CN111601542B - Capacitively coupled return path pad with separable array elements - Google Patents
Capacitively coupled return path pad with separable array elements Download PDFInfo
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- CN111601542B CN111601542B CN201880084135.7A CN201880084135A CN111601542B CN 111601542 B CN111601542 B CN 111601542B CN 201880084135 A CN201880084135 A CN 201880084135A CN 111601542 B CN111601542 B CN 111601542B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4887—Locating particular structures in or on the body
- A61B5/4893—Nerves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
- A61B5/1107—Measuring contraction of parts of the body, e.g. organ, muscle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0247—Pressure sensors
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
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- Pathology (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Surgical Instruments (AREA)
Abstract
The invention discloses a return pad for an electrosurgical system. The return pad includes a plurality of conductive members and a plurality of sensing devices. The conductive member is configured to receive a radio frequency current applied to a patient. The sensing device is configured to be able to detect at least one of: a nerve control signal applied to the patient; and movement of the anatomical feature of the patient caused by application of the nerve control signal.
Description
Cross Reference to Related Applications
This patent application claims the benefit of earlier filing date of U.S. provisional patent application 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," filed 3/30/5, clause 119 (e) of the united states code, the disclosure of which is incorporated by reference in its entirety.
The present patent application also claims the priority of U.S. provisional patent application Ser. No. 62/650,887 entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES" filed 3/30 of U.S. code 35, U.S. provisional patent application Ser. No. 62/650,877 entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROL" filed 3/30 of 2018, U.S. provisional patent application Ser. No. 62/650,877 entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM" filed 3/30 of 2018, the disclosure of each of which is incorporated herein by reference in its entirety, in accordance with the provisions of clause 119 (e) of the United states code 35.
This patent application also claims the benefit of priority from U.S. provisional patent application Ser. No. 62/640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR" filed on3 month 8 of the United states code, volume 35, clause 119 (e), and U.S. provisional patent application Ser. No. 62/640,415 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR", filed on3 month 8 of the United states code, the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.
The present patent application also claims the priority of U.S. provisional patent application Ser. No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM", filed on U.S. Ser. No. 62/611,340, filed on U.S. Ser. No. 62/340,340, entitled "CLOUD-BASED MEDICAL ANALYTICS", filed on U.S. Ser. No. 28, and U.S. provisional patent application Ser. No. 62/611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM", filed on U.S. Ser. No. 62/611,339, filed on 28, 12, and both filed on 28, 35, the disclosures of each of which are hereby incorporated by reference in their entirety.
Background
The present patent application discloses an invention that relates generally and in various aspects to surgical systems and return pads for electrosurgical systems.
Electrosurgical systems typically utilize a generator to supply electrosurgical energy (e.g., alternating current at a radio frequency level) to an active electrode that applies the electrosurgical energy to the patient's body. Electrosurgical energy applied to the patient's body is used to heat the patient's tissue (to seal and/or cut the tissue), and generally exits the patient's body to a return pad that may be applied to the patient's body or may be capacitively coupled to the patient's body. The return pad is connected to a return path wiring which in turn is connected back to the generator. In other words, the return pad and the return path wiring collectively form an electrical return path of the electrosurgical system.
One concern associated with electrosurgery is whether the discrete electrodes of the return pad are large enough and/or have sufficient surface area to adequately capture and carry the electrosurgical energy introduced into the patient's body so that unnecessary patient burns can be avoided. The return pad is typically sized to keep the current density low enough as the electrosurgical energy exits the patient. Otherwise, heat may build up in the patient and cause burns.
When cutting target tissue of a patient with electrosurgical energy, one concern is that one or more nerves may be inadvertently damaged and/or severed during the electrosurgical procedure, potentially causing the patient to experience muscle weakness, pain, numbness, paralysis, and/or other undesirable consequences. While the surgeon typically has a good knowledge of the location of the nerves and is thus able to avoid them, this is not always the case. For example, if a region of a patient is deformed, damaged, or otherwise deviates from what is considered normal, it may be difficult to determine the location of a given nerve within that region. When the location of a given nerve within the region is not readily discernable, the likelihood of inadvertently damaging or cutting the nerve increases.
Disclosure of Invention
In one aspect, a return pad for an electrosurgical system is provided. The return pad includes: a plurality of conductive members configured to receive radio frequency current applied to a patient; and a plurality of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal.
In another aspect, an electrosurgical system is provided. The electrosurgical system includes: a generator configured to be capable of supplying a radio frequency alternating current; an instrument configured to apply an alternating current to a patient; a return pad capable of capacitively coupling to a patient, wherein the return pad comprises: a plurality of conductive members configured to conduct radio frequency current, wherein the plurality of conductive members are capacitively coupleable to the patient and selectively coupleable to the generator; a plurality of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal; and a conductor coupled to the return pad and the generator.
In yet another aspect, a return pad for an electrosurgical system is provided. The return pad includes: a plurality of electrodes configured for capacitive coupling with a patient; and an array of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal.
Drawings
The features of the various aspects are particularly described in the appended claims. The various aspects (related to surgical organization and methods) and further objects and advantages thereof, however, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.
Fig. 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.
Fig. 3 is a surgical hub paired with a visualization system, robotic system, and intelligent instrument, in accordance with at least one aspect of the present disclosure.
Fig. 4 is a partial perspective view of a surgical hub housing and a combined generator module slidably receivable in a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure.
Fig. 5 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation component in accordance with at least one aspect of the present disclosure.
Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing configured to be able to receive a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 7 illustrates a vertical modular housing configured to be able to receive a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 8 illustrates a surgical data network including a modular communication hub configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical operations to a cloud in accordance with at least one aspect of the present disclosure.
Fig. 9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure.
Fig. 11 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.
Fig. 12 illustrates a logic diagram of a control system for a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 15 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure.
Fig. 17 is a schematic view of a robotic surgical instrument configured to operate a surgical tool described herein, in accordance with at least one aspect of the present disclosure.
Fig. 18 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.
Fig. 19 is a schematic view of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.
Fig. 20 is a simplified block diagram of a generator configured to provide, among other benefits, inductor-less tuning in accordance with at least one aspect of the present disclosure.
Fig. 21 illustrates an example of a generator that is one form of the generator of fig. 20 in accordance with at least one aspect of the present disclosure.
Fig. 22 illustrates an electrosurgical system in accordance with at least one aspect of the present disclosure.
Fig. 23 illustrates a return pad of the electrosurgical system of fig. 22 in accordance with at least one aspect of the present disclosure.
Fig. 24 illustrates a plurality of electrodes of the return pad of fig. 23 in accordance with at least one aspect of the present disclosure.
FIG. 25 illustrates an array of sensing devices of the return pad of FIG. 23 in accordance with at least one aspect of the present disclosure.
Fig. 26 illustrates a method for simultaneously applying a neural stimulation signal and electrosurgical energy to a patient in accordance with at least one aspect of the present disclosure.
Detailed Description
The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 2018, 6, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. __________, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS" (attorney docket number END8543 USNP/170760);
U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION" (attorney docket number END8543USNP 1/170760-1);
U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" (attorney docket number END8543USNP 2/170760-2);
U.S. patent application Ser. No. __________, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" (attorney docket number END8543 USNP/170760-3);
U.S. patent application Ser. No. __________, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES" (attorney docket number END8543 USNP/170760-4);
U.S. patent application Ser. No. __________, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE" (attorney docket number END8543USNP 5/170760-5);
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES" (attorney docket number END8543 USNP/170760-6);
U.S. patent application Ser. No. __________, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY" (attorney docket number END8543 USNP/170760-7);
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE" (attorney docket number END8544 USNP/170761);
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT" (attorney docket number END8544USNP 1/170761-1);
U.S. patent application Ser. No. __________, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY" (attorney docket number END8544USNP 2/170761-2);
U.S. patent application Ser. No. __________ entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES" (attorney docket number END8544USNP 3/170761-3);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL" (attorney docket number END8545 USNP/170762);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS" (attorney docket number END8545USNP 1/170762-1);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION FLOW PATHS" (attorney docket number END8545USNP 2/170762-2);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL" (attorney docket number END8545 USNP/170762-3);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SENSING AND DISPLAY" (attorney docket number END8545 USNP/170762-4);
U.S. patent application Ser. No. __________, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"( attorney docket number END8546 USNP/170763);
U.S. patent application Ser. No. __________, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM" (attorney docket number END8546USNP 1/170763-1);
U.S. patent application Ser. No. __________, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"( attorney docket number END8547 USNP/170764); and
U.S. patent application Ser. No. __________, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS" (attorney docket number END8548 USNP/170765).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 28 th 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/691,228, entitled "A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices";
U.S. provisional patent application Ser. No. 62/691,227, entitled "controlling a surgical instrument according to sensed closure parameters";
U.S. provisional patent application Ser. No. 62/691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. provisional patent application Ser. No. 62/691,219 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. provisional patent application Ser. No. 62/691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. provisional patent application Ser. No. 62/691,262, titled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; and
U.S. provisional patent application Ser. No. 62/691,251 entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".
The applicant of the present patent application owns the following U.S. provisional patent applications filed on date 19 of 2018, 4, the disclosures of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/659,900 entitled "METHOD OF HUB COMMUNICATION".
The applicant of the present patent application owns the following U.S. patent applications filed on day 29, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,641 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. patent application Ser. No. 15/940,648 entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITES";
U.S. patent application Ser. No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
U.S. patent application Ser. No. 15/940,666 entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";
U.S. patent application Ser. No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
U.S. patent application Ser. No. 15/940,677 entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
U.S. patent application Ser. No. 15/940,632 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. patent application Ser. No. 15/940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS";
U.S. patent application Ser. No. 15/940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. patent application Ser. No. 15/940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
U.S. patent application Ser. No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. patent application Ser. No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
U.S. patent application Ser. No. 15/940,668 entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
U.S. patent application Ser. No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. patent application Ser. No. 15/940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
U.S. patent application Ser. No. 15/940,700 entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
U.S. patent application Ser. No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. patent application Ser. No. 15/940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. patent application Ser. No. 15/940,722 entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY"; and
U.S. patent application Ser. No. 15/940,742 entitled "DUAL CMOS ARRAY IMAGING".
The applicant of the present patent application owns the following U.S. patent applications filed on day 29, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. patent application Ser. No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
U.S. patent application Ser. No. 15/940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. patent application Ser. No. 15/940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET";
U.S. patent application Ser. No. 15/940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION";
U.S. patent application Ser. No. 15/940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. patent application Ser. No. 15/940,706 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; and
U.S. patent application Ser. No. 15/940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES".
The applicant of the present patent application owns the following U.S. patent applications filed on day 29, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 15/940,627 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,637 entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,642 entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,676 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,680 entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,683 entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application Ser. No. 15/940,690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and
U.S. patent application Ser. No. 15/940,711 entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
The applicant of the present patent application owns the following U.S. provisional patent applications filed on day 28, 3, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application Ser. No. 62/649,302 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. provisional patent application Ser. No. 62/649,294 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. provisional patent application Ser. No. 62/649,300 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. provisional patent application Ser. No. 62/649,309 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. provisional patent application Ser. No. 62/649,310 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. provisional patent application Ser. No. 62/649,291 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. provisional patent application Ser. No. 62/649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. provisional patent application Ser. No. 62/649,333 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. provisional patent application Ser. No. 62/649,327 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. provisional patent application Ser. No. 62/649,315 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
U.S. provisional patent application Ser. No. 62/649,313 entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
U.S. provisional patent application Ser. No. 62/649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. provisional patent application Ser. No. 62/649,307 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and
U.S. provisional patent application Ser. No. 62/649,323 entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
It is to be understood that at least some of the figures and descriptions of the present invention have been simplified to illustrate relevant elements for a clear understanding of the present invention, while eliminating, for purposes of clarity, other elements that may also form a part of the present invention. However, since such elements are well known in the art and since they do not facilitate a better understanding of the present invention, a description of such elements is not provided herein.
In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like numerals and reference characters generally refer to like parts throughout the several views unless the context indicates otherwise. The illustrative aspects set forth in the detailed description, drawings, and claims are not intended to be limiting. Other aspects may be utilized, and other changes may be made, without departing from the scope of the techniques described herein.
The following description of certain examples of the present technology is not intended to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is by way of example, one of the best modes contemplated for carrying out the technology. As will be appreciated, the techniques described herein are capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
It should also be understood that any one or more of the teachings, expressions, aspects, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, aspects, embodiments, examples, etc. described herein. Thus, the following teachings, expressions, aspects, embodiments, examples, etc. should not be considered as being in isolation from each other. Various suitable ways in which the teachings herein may be combined will be apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the appended claims.
Before explaining the various aspects of the electrosurgical system, return pad and method in detail, it should be noted that the various aspects disclosed herein are not limited in their application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. Rather, the disclosed aspects can be arranged or incorporated in other aspects, embodiments, variations and modifications, and may be practiced or carried out in various ways. Accordingly, aspects of the electrosurgical system, return pad, and method disclosed herein are exemplary in nature and are not intended to limit the scope or application thereof. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the various aspects for the convenience of the reader and are not for the purpose of limiting the scope. Further, it should also be understood that any one or more of the disclosed aspects, expressions of aspects, and/or examples thereof may be combined with any one or more of the other disclosed aspects, expressions of aspects, and/or examples thereof, without limitation.
Also, in the following description, it is to be understood that terms such as inward, outward, upward, downward, above, below, left, right, interior, exterior, etc. are words of convenience and are not to be construed as limiting terms. The terms used herein are not intended to be limited to the scope of the devices described herein or portions thereof, but may be attached or utilized in other orientations. Various aspects will be described in more detail with reference to the accompanying drawings.
As described in more detail below, aspects of the invention may be implemented by a computing device and/or a computer program stored on a computer readable medium. The computer readable medium may include a disk, an apparatus, and/or a propagated signal.
Referring to fig. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., may include a cloud 104 coupled to a remote server 113 of a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with a cloud 104, which may include a remote server 113. In one example, as shown in fig. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a hand-held intelligent surgical instrument 112 configured to communicate with each other and/or with the surgical hub 106. In some aspects, the surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of hand-held intelligent surgical instruments 112, where M, N, O and P are integers greater than or equal to one.
Fig. 3 illustrates an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. When the surgeon views the surgical site through the surgeon's console 118, the patient-side cart 120 may manipulate at least one removably coupled surgical tool 117 through a minimally invasive incision in the patient. Images of the surgical site may be obtained by a medical imaging device 124 that may be maneuvered by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM) filed on month 12, 2017, the disclosure of which is incorporated herein by reference in its entirety.
Various examples of CLOUD-BASED analysis performed by the CLOUD 104 and suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on date 12, 2017, the disclosure of which is incorporated herein by reference in its entirety.
In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge Coupled Device (CCD) sensors and Complementary Metal Oxide Semiconductor (CMOS) sensors.
The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate multiple portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.
The one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may be referred to as visible light or simple light. A typical human eye will respond to wavelengths in the air of about 380nm to about 750 nm.
The invisible spectrum (i.e., the non-emission spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380nm and above about 750 nm). The human eye cannot detect the invisible spectrum. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisible Infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.
In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophageal-duodenal scopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.
In one aspect, the imaging device employs multispectral monitoring to distinguish between topography and underlying structures. Multispectral images are images that capture image data in a specific range of wavelengths across the electromagnetic spectrum. Wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green and blue receptors. Use of multispectral imaging is described in more detail under the heading "advanced imaging acquisition Module (ADVANCED IMAGING Acquisition Module)" of U.S. provisional patent application Ser. No. 62/611,341, entitled "Interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)", filed on month 12, 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety. After completing a surgical task to perform one or more of the previously described tests on the treated tissue, multispectral monitoring may be a useful tool for repositioning the surgical site.
It is self-evident that the operating room and surgical equipment need to be strictly sterilized during any surgical procedure. The stringent sanitary and sterilization conditions required in the "surgery room" (i.e., operating or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize the patient or any substance penetrating the sterile field, including the imaging device 124 and its attachments and components. It should be understood that a sterile field may be considered a designated area that is considered to be free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area surrounding a patient that is ready for a surgical procedure. The sterile field may include scrubbing team members that are properly worn, as well as all furniture and fixtures in the area.
In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically placed with respect to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging acquisition module (ADVANCED IMAGING Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.
As shown in fig. 2, the main display 119 is positioned in the sterile field to be visible to an operator at the operating table 114. Furthermore, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108, guided by the surgical hub 106, is configured to utilize the displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, the surgical hub 106 may cause the imaging system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a real-time feed of the surgical site on the main display 119. The snapshot on the non-sterile display 107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps related to a surgical procedure.
In one aspect, the surgical hub 106 is further configured to route diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 to a main display 119 within the sterile field, where the diagnostic inputs or feedback can be observed by a sterile operator at the operating table. In one example, the input may be a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be routed through the surgical hub 106 to the main display 119.
Referring to fig. 2, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. The surgical hub 106 is also configured to coordinate the flow of information to a display of the surgical instrument 112. See, for example, U.S. provisional patent application serial No. 62/611,341, filed on date 28 of 12 in 2017, entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM), the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 may be routed by the surgical hub 106 to the surgical instrument display 115 within the sterile field, where it may be observed by the operator of the surgical instrument 112. An exemplary surgical instrument suitable for use in surgical system 102 is described under the heading "surgical instrument hardware (Surgical Instrument Hardware)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 12 and 28 in 2017, the disclosure of which is incorporated herein by reference in its entirety, for example.
Referring now to fig. 3, the surgical hub 106 is depicted in communication with a visualization system 108, a robotic system 110, and a hand-held intelligent surgical instrument 112. The surgical hub 106 includes a surgical hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a memory array 134. In certain aspects, as shown in fig. 3, the surgical hub 106 further includes a smoke evacuation module 126 and/or an aspiration/irrigation module 128.
During surgical procedures, energy application to tissue for sealing and/or cutting is often associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid lines, power lines, and/or data lines from different sources are often entangled during a surgical procedure. Solving this problem during a surgical procedure can lose valuable time. Disconnecting the pipeline may require disconnecting the pipeline from its respective module, which may require resetting the module. The surgical hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.
Aspects of the present disclosure provide a surgical hub for a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a surgical hub housing and a combined generator module slidably received in a docking bay of the surgical hub housing. The docking station includes a data contact and a power contact. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component for connecting the combination generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid and/or particulates generated by application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the surgical hub housing. In one aspect, the surgical hub housing includes a fluid interface.
Certain surgical procedures may require more than one type of energy to be applied to tissue. One energy type may be more advantageous for cutting tissue, while a different energy type may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the surgical hub modular housing 136 is configured to house different generators and facilitate interactive communication therebetween. One of the advantages of the surgical hub modular housing 136 is the ability to quickly remove and/or replace various modules.
Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue. The modular surgical housing includes: a first one of the energy generator modules is configured to generate a first energy, the first energy generator module is configured to generate first energy for application to tissue; and a first docking station including a first docking port including a first data and power contact, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contact.
Further to the above, the modular surgical housing further comprises a second energy generator module configured to generate a second energy different from the first energy for application to the tissue, and a second docking station comprising a second docking port comprising a second data and power contact, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contact.
In addition, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
Referring to fig. 3-7, aspects of the present disclosure are presented as a surgical hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and aspiration/irrigation module 128. The surgical hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar and ultrasonic components supported in a single housing unit 139 slidably inserted into the surgical hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to be connectable to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the surgical hub modular housing 136. The surgical hub modular housing 136 may be configured to facilitate interactive communication between the insertion and docking of multiple generators into the surgical hub modular housing 136 such that the generators will act as a single generator.
In one aspect, the surgical hub modular housing 136 includes a modular power and communication backplane 149 having external and wireless communication connectors to enable removable attachment of the modules 140, 126, 128 and interactive communication therebetween.
In one aspect, the surgical hub modular housing 136 includes a docking cradle or drawer 151 (also referred to herein as a drawer) configured to slidably receive the modules 140, 126, 128. Fig. 4 shows a partial perspective view of the surgical hub housing 136 and the combined generator module 145 slidably receivable in the docking cradle 151 of the surgical hub housing 136. The docking ports 152 having power and data contacts on the back of the combined generator module 145 are configured to engage the corresponding docking ports 150 with the power and data contacts of the corresponding docking bays 151 of the surgical hub modular housing 136 when the combined generator module 145 is slid into place within the corresponding docking bays 151 of the surgical hub modular housing 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasound and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as shown in fig. 5.
In various aspects, smoke evacuation module 126 includes a fluid line 154, which fluid line 154 conveys trapped/collected smoke and/or fluid from the surgical site to, for example, smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid lines may be in the form of a flexible tube terminating at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path extending toward the smoke evacuation module 126 received in the surgical hub housing 136.
In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and an aspiration fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubing extending from the surgical site toward the aspiration/irrigation module 128. The one or more drive systems may be configured to flush fluid to and aspirate fluid from the surgical site.
In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, a draft tube, and an irrigation tube. The draft tube may have an inlet at its distal end and the draft tube extends through the shaft. Similarly, the draft tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic energy and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the shaft.
The flush tube may be in fluid communication with a fluid source and the draft tube may be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed in the suction/irrigation module 128. In one example, the fluid source and/or vacuum source may be housed in the surgical hub housing 136 independently of the aspiration/irrigation module 128. In such examples, the fluid interface can connect the aspiration/irrigation module 128 to a fluid source and/or a vacuum source.
In one aspect, the modules 140, 126, 128 and/or their corresponding docking mounts on the surgical hub modular housing 136 may include an alignment feature configured to align the docking ports of the modules into engagement with their corresponding ports in the docking mounts of the surgical hub modular housing 136. For example, as shown in fig. 4, combined generator module 145 includes side brackets 155, side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bays 151 of surgical hub modular housing 136. The brackets cooperate to guide the mating port contacts of the combined generator module 145 into electrical engagement with the mating port contacts of the surgical hub modular housing 136.
In some aspects, the drawers 151 of the surgical hub modular housing 136 are the same or substantially the same size, and the size of the modules are adjusted to be received in the drawers 151. For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are sized differently and each is designed to accommodate a particular module.
In addition, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer having unmatched contacts.
As shown in fig. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by a communication link 157 to facilitate interactive communication between modules housed in the surgical hub modular housing 136. Alternatively or additionally, the docking port 150 of the surgical hub modular housing 136 may facilitate wireless interactive communication between modules housed in the surgical hub modular housing 136. Any suitable wireless communication may be employed, such as AirTitan-Bluetooth, for example.
Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect the modules 161. The modules 161 are slidably inserted into the docking base 162 of the lateral modular housing 160, which lateral modular housing 160 includes a floor for interconnecting the modules 161. As shown in fig. 6, the modules 161 are laterally disposed in a lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.
Fig. 7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking bay or drawer 167 of a vertical modular housing 164, the vertical modular housing 164 including a floor for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are vertically arranged, in some cases, the vertical modular housing 164 may include drawers that are laterally arranged. Further, the modules 165 may interact with each other through the docking ports of the vertical modular housing 164. In the example of fig. 7, a display 177 for displaying data related to the operation of module 165 is provided. Further, the vertical modular housing 164 includes a main module 178 that houses a plurality of sub-modules slidably received in the main module 178.
In various aspects, the imaging module 138 includes an integrated video processor and modular light source and is adapted for use with various imaging devices. In one aspect, an imaging device is constructed of a modular housing that may be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, the light source module, and the camera module. The light source module and/or the camera module may be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Also, the light source module may be configured to deliver white light or different lights, depending on the surgical procedure.
During a surgical procedure, it may be inefficient to remove a surgical device from a surgical field and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporary loss of vision from the surgical field can have undesirable consequences. The modular imaging apparatus of the present disclosure is configured to allow for flow replacement of the light source module or the camera module during a surgical procedure without having to remove the imaging apparatus from the surgical site.
In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module, which may be configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module, which may be configured for snap-fit engagement with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Instead of snap-fit engagement, threaded engagement may be employed.
In various examples, multiple imaging devices are placed at different locations in a surgical field to provide multiple views. The imaging module 138 may be configured to be capable of switching between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to be capable of integrating images from different imaging devices.
Various image processors and imaging devices suitable for use in the present disclosure are described in U.S. patent 7,995,045, entitled combined SBI and conventional image processor (COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR), published 8/9/2011, which is incorporated herein by reference in its entirety. Furthermore, U.S. patent 7,982,776, entitled SBI motion artifact removal apparatus and method (SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD), published in 2011, 7, 19, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such a system may be integrated with the imaging module 138. In addition, U.S. patent application publication 2011/0306840 entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" published 12/15/2011 and U.S. patent application publication 2014/0243597 entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE" published 8/28/2014, the disclosures of each of which are incorporated herein by reference in their entirety.
Fig. 8 illustrates a surgical data network 201 including a modular communication hub 203, the modular communication hub 203 configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in a medical facility specifically equipped for surgical procedures to a cloud-based system (e.g., cloud 204, which may include remote server 213 coupled to storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 in communication with a network router. Modular communication hub 203 may also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured to be passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) and cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.
Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. The hub 207 and/or the network switch 209 may be coupled to a network router 211 to connect the devices 1a-1n to the cloud 204 or to a local computer system 210. The data associated with the devices 1a-1n may be transmitted via routers to cloud-based computers for remote data processing and manipulation. Data associated with the devices 1a-1n may also be transmitted to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with the devices 2a-2n may be transmitted to the cloud 204 via the network router 211 for data processing and manipulation. The data associated with the devices 2a-2m may also be transmitted to the local computer system 210 for local data processing and manipulation.
It should be appreciated that the surgical data network 201 may be extended by interconnecting a plurality of network hubs 207 and/or a plurality of network switches 209 with a plurality of network routers 211. Modular communication hub 203 may be included in a modular control tower configured to be capable of receiving a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be contained in a modular control tower. Modular communication hub 203 is connected to display 212 to display images obtained by some of devices 1a-1n/2a-2m, for example, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as a non-contact sensor module in an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, an aspiration/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and/or other modular devices that may be connected to a modular communication hub 203 of a surgical data network 201.
In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(s), and network router(s) that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the hub or switch may collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "types of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., stationary, mobile, temporary, or in-situ operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 through the internet. The cloud infrastructure may be maintained by a cloud service provider. In this case, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n/2a-2m located in one or more operating rooms. The cloud computing service may perform a large amount of computation based on data collected by intelligent surgical instruments, robots, and other computerized devices located in the operating room. Surgical hub hardware enables multiple devices or connections to be connected to a computer that communicates with cloud computing resources and memory.
Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical results, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of a disease, and data including images of body tissue samples for diagnostic purposes may be examined using cloud-based computing. This includes localization and marginal confirmation of tissue and phenotype. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques, such as overlaying images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve surgical procedure results by determining whether further treatment (such as endoscopic interventions, emerging techniques, targeted radiation, targeted interventions, and the application of precision robots to tissue-specific sites and conditions) may be continued, such data analysis may further employ result analysis processing, and may provide beneficial feedback to confirm or suggest modification of the surgical treatment and surgeon's behavior using standardized methods.
In one implementation, operating room devices 1a-1n may be connected to modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of devices 1a-1n to the hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating on the physical layer of the Open Systems Interconnection (OSI) model. The hub provides a connection to the devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and sends it to the router in half duplex mode. The hub 207 does not store any media access control/internet protocol (MAC/IP) for transmitting device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 has no routing tables or intelligence about where to send information and broadcast all network data on each connection and all network data to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as collisions, but broadcasting all information to multiple ports may pose a security risk and cause bottlenecks.
In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired channel or a wireless channel. The network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to a network. The network switch 209 sends data to the network router 211 in the form of frames and operates in full duplex mode. Multiple devices 2a-2m may transmit data simultaneously through network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.
The hub 207 and/or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. Network router 211 creates a route for transmitting data packets received from network hub 207 and/or network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of devices 1a-1n/2a-2 m. Network router 211 may be employed to connect two or more different networks located at different locations, such as, for example, different operating rooms at the same medical facility or different networks located at different operating rooms at different medical facilities. The network router 211 sends data in packets to the cloud 204 and operates in full duplex mode. Multiple devices may transmit data simultaneously. The network router 211 uses the IP address to transmit data.
In one example, the hub 207 may be implemented as a USB hub that allows multiple USB devices to connect to a host. USB hubs can extend a single USB port to multiple tiers so that more ports are available to connect devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.
In other examples, operating room devices 1a-1n/2a-2m may communicate with modular communication hub 203 via bluetooth wireless technology standards for exchanging data from stationary devices and mobile devices and constructing Personal Area Networks (PANs) over short distances (using short wavelength UHF radio waves of 2.4 to 2.485GHz in the ISM band). In other aspects, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 family), wiMAX (IEEE 802.16 family), IEEE 802.20, long Term Evolution (LTE) and Ev-DO, hspa+, hsdpa+, hsupa+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, wiMAX, LTE, ev-DO, etc.
The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a type of data called frames. The frames carry data generated by the devices 1a-1n/2a-2 m. When the modular communication hub 203 receives the frame, it is amplified and transmitted to the network router 211, which network router 211 transmits the data to the cloud computing resources using a plurality of wireless or wired communication standards or protocols as described herein.
Modular communication hub 203 may be used as a stand-alone device or connected to a compatible hub and network switch to form a larger network. Modular communication hub 203 is generally easy to install, configure, and maintain, making it a good option for networking operating room devices 1a-1n/2a-2 m.
Fig. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236, the modular control tower 236 being connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room. As shown in fig. 10, modular control tower 236 includes a modular communication hub 203 coupled to computer system 210. As shown in the example of fig. 9, modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239, generator module 240 coupled to energy device 241, smoke evacuation module 226, aspiration/irrigation module 228, communication module 230, processor module 232, storage array 234, smart device/instrument 235 optionally coupled to display 237, and non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. The robotic hub 222 may also be connected to a modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via a wired or wireless communication standard or protocol, as described herein. The modular control tower 236 can be coupled to the surgical hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization system 208. The surgical hub display may also combine the images and the overlay images to display data received from devices connected to the modular control tower.
Fig. 10 illustrates a surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 10, modular communication hub 203 may be hierarchically configured to connect to expand the number of modules (e.g., devices) that may be connected to modular communication hub 203 and transmit data associated with the modules to computer system 210, cloud computing resources, or both. As shown in fig. 10, each of the hubs/switches in modular communications hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with cloud 204 may be through a wired or wireless communication channel.
The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and uses ultrasonic or laser type non-contact measurement devices to generate a map of the surgical room. The ultrasound-based non-contact sensor module scans the Operating Room by transmitting a burst of ultrasound waves and receiving echoes as it bounces off the enclosure of the Operating Room, as described under the heading "Surgical Hub space perception within the Operating Room" in U.S. provisional patent application serial No. 62/611,341 entitled "interactive Surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on day 12, 2017, which is incorporated herein by reference in its entirety, wherein the sensor module is configured to be able to determine the size of the Operating Room and adjust bluetooth pairing distance limits. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses that bounce off the enclosure of the operating room, and comparing the phase of the emitted pulses with the received pulses to determine the size of the operating room and adjust the bluetooth pairing distance limit.
Computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input/output interface 251. The system bus may be any of several types of bus structure including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, industry Standard Architecture (ISA), micro-Charmel architecture (MSA), extended ISA (EISA), intelligent Drive Electronics (IDE), VESA Local Bus (VLB), peripheral Component Interconnect (PCI), USB, advanced Graphics Port (AGP), personal computer memory card international association bus (PCMCIA), small Computer System Interface (SCSI), or any other peripheral bus.
The controller 244 may be any single or multi-core processor, such as those provided by Texas instruments Inc. (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be an on-chip memory available from, for example, texas instruments (Texas Instruments) LM4F230H5QR ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz), a prefetch buffer for improving performance above 40MHz, 32KB single-cycle Sequential Random Access Memory (SRAM), loaded withInternal read-only memory (ROM) of software, 2KB electrically erasable programmable read-only memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Inputs (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, the details of which can be seen in the product data sheet.
In one aspect, the processor 244 may include a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R also produced by texas instruments (Texas Instruments). The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
The system memory includes volatile memory and nonvolatile memory. A basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, the non-volatile memory may include ROM, programmable ROM (PROM), electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDR SDRAM) Enhanced SDRAM (ESDRAM), synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).
Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, magnetic disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, jaz drives, zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.
It is to be appreciated that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environment. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored either in system memory or on disk storage. It is to be appreciated that the various components described herein can be implemented with various operating systems or combinations of operating systems.
A user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices are connected to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial, parallel, game, and USB. The output device(s) use the same type of port as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (e.g., monitors, displays, speakers, and printers) that require special adapters among other output devices. Other devices or systems of devices, such as remote computer(s), provide both input and output capabilities.
Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as a cloud computer(s), or local computers. The remote cloud computer(s) may be a personal computer, a server, a router, a network PC, a workstation, a microprocessor based appliance, a peer device or other common network node and the like, and typically includes many or all of the elements described relative to computer systems. For simplicity, only memory storage devices having remote computer(s) are shown. The remote computer(s) is logically connected to the computer system through a network interface and then physically connected via communication connection. The network interface encompasses communication networks such as local-area networks (LAN) and wide-area networks (WAN). LAN technologies include Fiber Distributed Data Interface (FDDI), copper Distributed Data Interface (CDDI), ethernet/IEEE 802.3, token ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).
In various aspects, the computer system 210, imaging module 238 and/or visualization system 208 of fig. 10, and/or the processor module 232 of fig. 9-10 may include an image processor, an image processing engine, a media processor, or any special purpose Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computation with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.
Communication connection(s) refers to hardware/software for connecting a network interface to a bus. Although shown as a communication connection for exemplary clarity within a computer system, it can also be external to computer system 210. The hardware/software necessary for connection to the network interface includes, for exemplary purposes only, internal and external technologies such as, modems including regular telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
Fig. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with one aspect of the present disclosure. In the illustrated aspect, USB hub device 300 employs a TUSB2036 integrated circuit hub of texas instruments (Texas Instruments). The USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP 0) input paired with a differential data positive (DM 0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including differential data positive (DP 1-DP 3) outputs paired with differential data negative (DM 1-DM 3) outputs.
The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry for the upstream USB transceiver port 302 and all of the downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed and low speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured in a bus powered mode or a self-powered mode and include surgical hub power logic 312 for managing power.
The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in chapter 8 of the USB specification. SIE 310 generally includes signaling up to the transaction level. The processing functions thereof can include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and surgical hub repeater circuitry 318 to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 through port logic circuitry 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from a serial EEPROM via serial EEPROM interface 330.
In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using standardized four-wire cables that provide both communication and power distribution. The power is configured in a bus power mode and a self-powered mode. USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or ganged port power management, and self-powered hubs with individual port power management or ganged port power management. In one aspect, the USB hub 300, the upstream USB transceiver port 302, are plugged into a USB host controller using USB cables, and the downstream USB transceiver ports 304, 306, 308 are exposed for connection to USB compatible devices, etc.
Fig. 12 illustrates a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461, the microcontroller 461 including a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor drive 492 is operably coupled to the longitudinally movable displacement member to drive the I-beam knife element. The tracking system 480 is configured to determine a position of the longitudinally movable displacement member. The position information is provided to a processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member and the position of the firing member, firing bar, and I-beam knife element. Additional motors may be provided at the tool driver interface to control I-beam firing, closure tube travel, shaft rotation, and articulation. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data input. The information displayed on the display 473 may be superimposed with the image acquired via the endoscopic imaging module.
In one aspect, microprocessor 461 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas instruments Inc. (Texas Instruments). In one aspect, the master microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from, for example, texas instruments Inc. (Texas Instruments), which includes 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz) on-chip memory, a prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI simulations, and/or one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.
In one aspect, the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R also produced by texas instruments company (Texas Instruments). The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
The microcontroller 461 can be programmed to perform various functions such as precise control of the speed and position of the knife and articulation system. In one aspect, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed Direct Current (DC) motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, motor drive 492 is a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system. A detailed description of absolute positioning systems is described in U.S. patent application publication 2017/0296213, entitled system and method (SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT) for controlling a surgical stapling and severing instrument, published at 10 and 19 in 2017, which is incorporated herein by reference in its entirety.
The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 may be configured to be able to calculate responses in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used in the actual feedback decision. The observed response is an advantageous tuning value that equalizes the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.
In one aspect, the motor 482 can be controlled by a motor drive 492 and can be employed by a firing system of the surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of about 25,000 rpm. In other arrangements, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including a Field Effect Transistor (FET). The motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery that may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium ion battery, which may be coupled to and separable from the power component.
Driver 492 is a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). A3941 492 is a full bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed DC motors. The driver 492 includes a unique charge pump regulator that provides full (> 10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the above-described battery supply voltage required for an N-channel MOSFET. The internal charge pump of the high side drive allows dc (100% duty cycle) operation. Diodes or synchronous rectification may be used to drive the full bridge in either a fast decay mode or a slow decay mode. In slow decay mode, current recirculation may pass through either the high-side or low-side FETs. The dead time, which is adjustable by a resistor, protects the power FET from breakdown. The overall diagnostics provide indications of brown-out, over-temperature, and power bridge faults, and may be configured to protect the power MOSFET during most short circuit conditions. Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system.
Tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 in accordance with an aspect of the present disclosure. A position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member that includes a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or I-beam, each of which may be adapted and configured as a rack that can include drive teeth. Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member is coupled to the firing member, the firing bar, and the I-beam. Thus, the absolute positioning system may actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 adapted to measure linear displacement. Thus, a longitudinally movable drive member, firing bar, or I-beam, or combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact type displacement sensor or a non-contact type displacement sensor. The linear displacement sensor may include a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system including a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system including a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system including a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
The electric motor 482 may include a rotatable shaft operatively interfacing with a gear assembly mounted on the displacement member in meshing engagement with a set or rack of drive teeth. The sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor arrangement may be connected to the linear actuator via a rack and pinion arrangement, or to the rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system and the output indicator may display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member that includes racks of drive teeth formed thereon for meshing engagement with corresponding drive gears of the gear reducer assembly. The displacement member represents a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.
The single rotation of the sensor element associated with position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after the single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via gear reduction that causes the position sensor 472 to complete only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.
A series of switches (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. The state of the switch is fed back to the microcontroller 461, which microcontroller 461 applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+ … dn of the displacement member. The output of the position sensor 472 is provided to a microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (e.g., a potentiometer), an array of analog hall effect elements that output a unique combination of position signals or values.
The position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or vector component of the magnetic field. Technologies for producing the two types of magnetic sensors described above cover a number of aspects of physics and electronics. Techniques for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spin, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoresistance, magnetostriction/piezoelectric composites, magneto-sensitive diodes, magneto-sensitive transistors, optical fibers, magneto-optical, and microelectromechanical system based magnetic sensors, among others.
In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system includes a magnetic rotational absolute positioning system. The position sensor 472 may be implemented AS an AS5055EQFT monolithic magnetic rotation position sensor, commercially available from Austria Microsystems (AG). The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power component and includes four hall effect elements located in the area of the position sensor 472 on the magnet. A high resolution ADC and intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as bitwise and Volder algorithm) is provided to perform simple and efficient algorithms to calculate hyperbolic functions and trigonometric functions, which require only addition, subtraction, digital displacement and table lookup operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 through a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12 or 14 bit resolution. The site sensor 472 may be an AS5055 chip provided in a small QFN 16 pin 4mm x 0.85mm package.
The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, status feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the locations measured by location sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) may include sensor arrangements such as those described in the following patents: U.S. patent 9,345,481, entitled staple cartridge tissue thickness sensor system (STAPLE CARTRIDGE TISSUE THICKNESS), issued 5/24/2016, the entire disclosure of which is incorporated herein by reference; U.S. patent application publication 2014/0263552 entitled staple cartridge tissue thickness sensor system (STAPLE CARTRIDGE TISSUE THICKNESS), published at 9/18 of 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 15/628,175, entitled technique for adaptive control of motor speed for surgical stapling and cutting instruments (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT), filed on 6/20 of 2017, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a limited resolution and sampling frequency. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the inputs.
Thus, the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument and does not retract or advance the displacement member to a reset (clear or home) position as may be required by conventional rotary encoders that merely count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, or the like.
The sensor 474 (such as, for example, a strain gauge or a micro-strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, an amplitude of strain exerted on the anvil during a clamping operation, which may be indicative of a closing force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Alternatively or in addition to the sensor 474, a sensor 476 (such as a load sensor) may measure the closing force applied to the anvil by the closure drive system. A sensor 476, such as a load sensor, may measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge sled configured to cam the staple drivers upward to push staples out into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to sever tissue when the I-beam is advanced distally through the firing bar. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The force required to advance the firing member may correspond to, for example, the current consumed by the motor 482. The measured force is converted to a digital signal and provided to the processor 462.
In one form, the strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. A strain gauge may be coupled to the end effector to measure forces on tissue being treated by the end effector. A system for measuring force applied to tissue grasped by an end effector includes a strain gauge sensor 474, such as, for example, a microstrain gauge, configured to measure one or more parameters of the end effector, for example. In one aspect, the strain gauge sensor 474 can measure an amplitude or magnitude of strain applied to the jaw member of the end effector during a clamping operation, which can be indicative of tissue compression. The measured strain is converted to a digital signal and provided to a processor 462 of the microcontroller 461. Load sensor 476 may measure a force used to operate a knife element, for example, to cut tissue trapped between an anvil and a staple cartridge. A magnetic field sensor may be employed to measure the thickness of the trapped tissue. The measurements of the magnetic field sensors may also be converted to digital signals and provided to the processor 462.
The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the sensors 474, 476, respectively, to characterize corresponding values of the selected position of the firing member and/or the speed of the firing member. In one example, the memory 468 may store techniques, formulas, and/or look-up tables that may be employed by the microcontroller 461 in the evaluation.
The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with a modular communication hub, as shown in fig. 8-11.
Fig. 13 illustrates a control circuit 500, the control circuit 500 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to enable the various processes described herein. The circuit 500 may include a microcontroller including one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement the various processes described herein. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. Memory circuit 504 may include volatile storage media and nonvolatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.
Fig. 14 illustrates a combinational logic circuit 510, the combinational logic circuit 510 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. Combinational logic circuit 510 may be configured to enable the various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512, the combinational logic 512 being configured to receive data associated with a surgical instrument or tool at input 514, process the data through the combinational logic 512 and provide output 516.
Fig. 15 illustrates a sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool in accordance with an aspect of the present disclosure. Sequential logic 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from the input 526, process the data through the combinational logic 522 and provide the output 528. In other aspects, the circuitry may include a combination of a processor (e.g., processor 502, fig. 13) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may comprise a combination of combinational logic circuitry (e.g., combinational logic circuitry 510, fig. 14) and sequential logic circuitry 520.
Fig. 16 illustrates a surgical instrument or tool including multiple motors that may be activated to perform various functions. In some cases, a first motor may be activated to perform a first function, a second motor may be activated to perform a second function, and a third motor may be activated to perform a third function. In some instances, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing motions, closing motions, and/or articulation in the end effector. Firing motions, closing motions, and/or articulation may be transmitted to the end effector, for example, by a shaft assembly.
In some instances, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operably coupled to a firing motor drive assembly 604 that may be configured to transmit firing motions generated by the motor 602 to an end effector, particularly for displacing I-beam elements. In some instances, the firing motion generated by the motor 602 may cause, for example, staples to be deployed from a staple cartridge into tissue captured by the end effector and/or cause the cutting edge of the I-beam member to be advanced to cut the captured tissue. The I-beam element may be retracted by reversing the direction of motor 602.
In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to transmit a closure motion generated by the motor 603 to the end effector, in particular for displacing a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closing motion may transition, for example, the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
In some instances, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operatively coupled to respective articulation motor drive assemblies 608a, 608b that may be configured to transmit articulation generated by the motors 606a, 606b to the end effector. In some cases, articulation may cause the end effector to articulate relative to a shaft, for example.
As described above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire a plurality of staples and/or advance the cutting edge while the articulation motor 606 remains inactive. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to distally advance the closure tube and I-beam elements, as described in more detail below.
In some instances, a surgical instrument or tool may include a common control module 610, which common control module 610 may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may adjust one of the plurality of motors at a time. For example, the common control module 610 may be individually coupled to and separable from multiple motors of the surgical instrument. In some instances, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In some instances, multiple motors of a surgical instrument or tool may independently and selectively engage a common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.
In at least one example, the common control module 610 can be selectively switched between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may be movable or transitionable between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 may electrically couple the common control module 610 to the close motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some instances, a separate common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.
Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor for actuating the jaws.
In various cases, as shown in fig. 16, the common control module 610 may include a motor driver 626, which motor driver 626 may include one or more H-bridge field effect FETs. The motor driver 626 may regulate power transmitted from a power source 628 to a motor coupled to the common control module 610, e.g., based on input from the microcontroller 620 ("controller"). In some cases, when the motors are coupled to the common control module 610, the microcontroller 620 may be employed, for example, to determine the current consumed by the motors, as described above.
In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform the various functions and/or computations described herein. In some cases, one or more of the memory units 624 may be coupled to the processor 622, for example.
In some cases, power source 628 may be used, for example, to power microcontroller 620. In some cases, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some instances, the battery pack may be configured to be releasably mountable to the handle for powering the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 628. In some cases, the power source 628 may be, for example, replaceable and/or rechargeable.
In various circumstances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or deactivate the motor coupled to the common controller 610. It should be appreciated that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functionality of the Central Processing Unit (CPU) of a computer on one integrated circuit or at most a few integrated circuits. A processor is a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, this is an example of sequential digital logic. The objects of operation of the processor are numbers and symbols represented in a binary digital system.
In one example, the processor 622 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas instruments Inc. (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR purchased from texas instruments (Texas Instruments). In at least one example, texas Instruments LM F230H5QR is an ARM Cortex-M4F processor core comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features that are readily available. Other microcontrollers could be easily replaced for use with the module 4410. Accordingly, the present disclosure should not be limited in this context.
In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closure motor 603, and the articulation motors 606a, 606 b. Such program instructions may cause the processor 622 to control firing, closing, and articulation functions in accordance with inputs from algorithms or control programs for the surgical instrument or tool.
In some cases, one or more mechanisms and/or sensors (such as, for example, sensor 630) may be used to alert the processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 may alert the processor 622 to use program instructions associated with firing, closing, and articulation end effectors. In some cases, the sensor 630 may include, for example, a position sensor that may be used to sense the position of the switch 614. Thus, the processor 622 may use program instructions associated with firing the I-beam of the end effector when the switch 614 is detected in the first position 616, for example, by the sensor 630; processor 622 may use program instructions associated with closing the anvil upon detecting, for example, by sensor 630 that switch 614 is in second position 617; and the processor 622 may use program instructions associated with articulating the end effector when it is detected, for example by the sensor 630, that the switch 614 is in the third position 618a or the fourth position 618 b.
Fig. 17 is a schematic view of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control the firing member, the closure member, the shaft member, and/or one or more articulation members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, and/or one or more articulation members.
In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702, the removable staple cartridge 718, the shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704 e. The position sensor 734 may be configured to provide position feedback of the I-beam 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. Timer/counter 731 provides timing and count information to control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. Motors 704a-704e may be individually operated in open loop or closed loop feedback control by control circuit 710.
In one aspect, control circuitry 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause one or more processors to perform one or more tasks. In one aspect, a timer/counter 731 provides an output signal, such as a elapsed time or a digital count, to the control circuit 710 to correlate the position of the I-beam 714 as determined by the position sensor 734 to the output of the timer/counter 731 so that the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to a starting position or the time (t) when the I-beam 714 is at a particular position relative to the starting position. The timer/counter 731 may be configured to be able to measure elapsed time, count external events, or time external events.
In one aspect, the control circuitry 710 may be programmed to control the functionality of the end effector 702 based on one or more tissue conditions. Control circuit 710 may be programmed to directly or indirectly sense a tissue condition, such as thickness, as described herein. The control circuit 710 may be programmed to select a firing control routine or a closure control routine based on the tissue condition. The firing control procedure may describe distal movement of the displacement member. Different firing control procedures may be selected to better address different tissue conditions. For example, when thicker tissue is present, control circuit 710 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, control circuit 710 may be programmed to translate the displacement member at a higher speed and/or with a higher power. The closure control program may control the closure force applied to the tissue by the anvil 716. Other control programs control rotation of the shaft 740 and the articulation members 742a, 742 b.
In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to the corresponding motor drive signal. In some examples, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, motor controllers 708a-708e may be omitted and control circuit 710 may directly generate motor drive signals.
In some examples, control circuit 710 may initially operate each of motors 704a-704e in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a firing control routine in a closed loop configuration. The response of the instrument may include the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 710 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e to translate the displacement member at a constant speed based on translation data describing the position of the displacement member in a closed-loop manner.
In one aspect, motors 704a-704e may receive power from energy source 712. The energy source 712 may be a DC power source driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to individual movable mechanical elements, such as I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706 e. The transmissions 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the I-beam 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the I-beam 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the I-beam 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the I-beam 714. Also, in some examples, the position sensor 734 may be omitted. In the case where any of motors 704a-704e is a stepper motor, control circuit 710 may track the position of I-beam 714 by aggregating the number and direction of steps that motor 704 has been commanded to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.
In one aspect, the control circuit 710 is configured to drive a firing member, such as an I-beam 714 portion of the end effector 702. Control circuit 710 provides a motor setpoint to motor control 708a, which provides a drive signal to motor 704 a. An output shaft of motor 704a is coupled to torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a that is coupled to the I-beam 714. The transmission 706a includes movable mechanical elements such as rotary elements and firing members to control the movement of the I-beam 714 distally and proximally along the longitudinal axis of the end effector 702. In one aspect, motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. Torque sensor 744a provides a firing force feedback signal to control circuit 710. The firing force signal represents the force required to fire or displace the I-beam 714. The position sensor 734 may be configured to provide the position of the I-beam 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708 a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to an end-of-stroke position distal to the stroke start position. As the firing member is translated distally, the I-beam 714 with the cutting element positioned at the distal end is advanced distally to cut tissue between the staple cartridge 718 and the anvil 716.
In one aspect, the control circuit 710 is configured to drive a closure member, such as an anvil 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which motor control 708b provides a drive signal to the motor 704 b. An output shaft of motor 704b is coupled to torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b that is coupled to the anvil 716. The actuator 706b includes movable mechanical elements such as rotary elements and closure members to control movement of the anvil 716 from the open and closed positions. In one aspect, motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal is indicative of the closing force applied to the anvil 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 may provide a closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, control circuit 710 may provide a close signal to motor control 708 b. In response to the closure signal, motor 704b advances the closure member to grasp tissue between anvil 716 and staple cartridge 718.
In one aspect, the control circuit 710 is configured to enable rotation of a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708c, which motor control 708c provides a drive signal to the motor 704 c. An output shaft of motor 704c is coupled to torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c that is coupled to a shaft 740. The actuator 706c includes a movable mechanical element, such as a rotating element, to control the shaft 740 to rotate more than 360 degrees clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) a proximal end of the proximal closure tube for operative engagement by a rotary gear assembly that is operably supported on the tool mounting plate. Torque sensor 744c provides a rotational force feedback signal to control circuit 710. The rotational force feedback signal is indicative of the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
In one aspect, the control circuitry 710 is configured to enable articulation of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. The output of motor 704d is coupled to torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d that is coupled to an articulation member 742a. The transmission 706d includes movable mechanical elements, such as articulation elements, to control articulation of the end effector 702 + -65 deg.. In one aspect, the motor 704d is coupled to an articulation nut rotatably journaled on the proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is representative of the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.
In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate discs on the robotic interface (rack) that are driven by the two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b may be antagonistic driven relative to the other link to provide resistance preserving motion and load to the head when the head is not moving and articulation when the head is articulating. The articulation members 742a, 742b attach to the head at a fixed radius as the head rotates. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more pronounced for other articulation link drive systems.
In one aspect, one or more of the motors 704a-704e can include a brushed DC motor with a gear box and a mechanical link with a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces, which act against one of the electric motors 704a-704e. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotational absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotational position sensor, commercially available from Austria Microsystems (AG). Position sensor 734 interfaces with control circuit 710 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations, and table lookup operations.
In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression and time, and anvil strain and time. The sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 can be located on the deck of the staple cartridge 718 to determine tissue location using segmented electrodes. The torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, and the like. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the staple cartridge 718 having tissue thereon, and (4) the load and position on the two articulation bars.
In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the anvil 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may comprise a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect an impedance of a tissue section located between the anvil 716 and the staple cartridge 718 that is indicative of the thickness and/or integrity of the tissue located therebetween.
In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, hall effect devices, magnetoresistive (MR) devices, giant Magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 738 may include non-electrical conductor switches, ultrasonic switches, accelerometers, inertial sensors, and the like.
In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the anvil 716. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closing force applied by the closure tube to the anvil 716. The force exerted on the anvil 716 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. Control circuitry 710 receives real-time sample measurements to provide and analyze time-based information and evaluate in real-time the closing force applied to anvil 716.
In one aspect, a current sensor 736 may be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the I-beams 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to control circuit 710. Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the I-beam 714 in the end effector 702 at or near a target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controllers. The robotic surgical instrument 700 may include a power source to convert signals from a feedback controller into physical inputs, such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled closed loop speed control technique for robotic surgical instruments (CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT), filed on publication No. 6/29, 2017, which is incorporated herein by reference in its entirety.
Fig. 18 illustrates a block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as an I-beam 764. The surgical instrument 750 includes an end effector 752, which may include an anvil 766, an I-beam 764 (including a sharp cutting edge), and a removable staple cartridge 768.
The position, movement, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764. In some examples, the control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed or a digital count, to control circuit 760 to correlate the position of I-beam 764 as determined by position sensor 784 with the output of timer/counter 781 so that control circuit 760 can determine the position of I-beam 764 relative to a starting position at a particular time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or time external events.
Control circuit 760 may generate motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide motor drive signals 774 to the motor 754 to drive the motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some examples, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.
Motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to an I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage members to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuitry 760 may track the position of I-beam 764 by aggregating the number and direction of steps that motor 754 has been instructed to perform. The position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.
Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.
The one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and cartridge 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the anvil 766 and the staple cartridge 768 that is indicative of a thickness and/or completeness of tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.
A current sensor 786 may be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted to a digital signal and provided to control circuitry 760.
The control circuitry 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the I-beam 764 in the end effector 752 at or near a target speed. Surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, status feedback, LQR, and/or adaptive controllers. The surgical instrument 750 may include a power source to convert signals from a feedback controller into physical inputs, such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example.
The actual drive system of the surgical instrument 750 is configured to drive a displacement member, cutting member, or I-beam 764 through a brushed DC motor having a gear box and mechanical link with an articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and an articulation driver, such as an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on a physical system. Such external effects may be referred to as drag forces acting against the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 with a motor-driven surgical stapling and severing tool. For example, the motor 754 may drive the displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable anvil 766 and, when configured for use, the staple cartridge 768 is positioned opposite the anvil 766. The clinician may grasp tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along a longitudinal axis of the end effector 752 from a proximal stroke start position to an end-of-stroke position distal to the stroke start position. As the displacement member translates distally, the I-beam 764 with the cutting element positioned at the distal end may cut tissue between the staple cartridge 768 and the anvil 766.
In various examples, surgical instrument 750 may include control circuitry 760 programmed to control distal translation of a displacement member (such as I-beam 764) based on one or more tissue conditions. The control circuit 760 may be programmed to directly or indirectly sense a tissue condition, such as thickness, as described herein. The control circuit 760 may be programmed to select a firing control routine based on the tissue condition. The firing control procedure may describe distal movement of the displacement member. Different firing control procedures may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and/or with lower power. When thinner tissue is present, control circuitry 760 may be programmed to translate the displacement member at a higher speed and/or with a higher power.
In some examples, control circuit 760 may operate motor 754 initially in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the sum of the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the pulse width of the motor drive signal, and the like. After the open loop portion, the control circuit 760 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 based on translation data describing the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application Ser. No. 15/720,852, entitled System and method for controlling a display of a surgical instrument (SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT), filed on publication No. 9/29, 2017, which is incorporated herein by reference in its entirety.
Fig. 19 is a schematic view of a surgical instrument 790 configured to control various functions in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control distal translation of a displacement member, such as an I-beam 764. Surgical instrument 790 includes an end effector 792 that may comprise an anvil 766, an I-beam 764, and a removable staple cartridge 768 that is interchangeable with an RF cartridge 796 (shown in phantom).
In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid state switch, a hall effect device, an MR device, a GMR device, a magnetometer, or the like. In other implementations, the sensor 638 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensor 788 may include a conductor-less electrical switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.
In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a magnetic rotational absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotational position sensor, available from Austria Microsystems (AG). Position sensor 784 interfaces with control circuit 760 to provide an absolute positioning system. The location may include a plurality of hall effect elements located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations, and table lookup operations.
In one aspect, the I-beam 764 may be implemented as a knife member including a knife body that operably supports a tissue cutting blade thereon, and may further include an anvil-engaging tab or feature and a channel-engaging feature or foot. In one aspect, staple cartridge 768 can be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF bin 796 may be implemented as an RF bin. These and other sensor arrangements are described in commonly owned U.S. patent application Ser. No. 15/628,175, entitled technique for adaptive control of motor speed for surgical stapling and cutting instruments (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT), filed on even date 20 at 6 in 2017, which is incorporated herein by reference in its entirety.
The position, movement, displacement, and/or translation of a linear displacement member, such as an I-beam 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor, represented as position sensor 784. Since the I-beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the I-beam 764 may be achieved by the position sensor 784 as described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as an I-beam 764, as described herein. In some examples, the control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed or a digital count, to control circuit 760 to correlate the position of I-beam 764 as determined by position sensor 784 with the output of timer/counter 781 so that control circuit 760 can determine the position of I-beam 764 relative to a starting position at a particular time (t). Timer/counter 781 may be configured to be able to measure elapsed time, count external events, or time external events.
Control circuit 760 may generate motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide motor drive signals 774 to the motor 754 to drive the motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some examples, the motor controller 758 may be omitted and the control circuit 760 may directly generate the motor drive signal 774.
Motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to an I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other linkage members to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuitry 760 may track the position of I-beam 764 by aggregating the number and direction of steps that the motor has been instructed to perform. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.
Control circuitry 760 can be in communication with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters, such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.
The one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between anvil 766 and cartridge 768. The sensor 788 may be configured to detect an impedance of a tissue segment located between the anvil 766 and the staple cartridge 768 that is indicative of a thickness and/or completeness of tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the anvil 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the anvil 766 to detect a closing force applied by the closure tube to the anvil 766. The force exerted on the anvil 766 may be indicative of the tissue compression experienced by the section of tissue trapped between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during a clamping operation. Control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to anvil 766 in real-time.
A current sensor 786 may be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted to a digital signal and provided to control circuitry 760.
When an RF cartridge 796 is loaded in the end effector 792 in place of the staple cartridge 768, an RF energy source 794 is coupled to the end effector 792 and applied to the RF cartridge 796. Control circuitry 760 controls the delivery of RF energy to RF bin 796.
Additional details are disclosed in U.S. patent application Ser. No. 15/636,096, filed on 6/28 of 2017, entitled surgical System coupleable with a staple cartridge and a radio frequency cartridge, the entire disclosure of which is incorporated herein by reference, and methods (SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE,AND METHOD OF USING SAME), for use thereof.
Fig. 20 is a simplified block diagram of a generator 800 configured to provide, among other benefits, inductor-less tuning. Additional details of generator 800 are described in U.S. patent 9,060,775, entitled surgical generator (SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES) for ultrasonic and electrosurgical devices, published on month 23 of 2015, which is incorporated herein by reference in its entirety. The generator 800 may include a patient isolation stage 802 that communicates with a non-isolation stage 804 via a power transformer 806. The secondary winding 808 of the power transformer 806 is included in the isolation stage 802 and may include a tap configuration (e.g., a center-tap or non-center-tap configuration) to define drive signal outputs 810a,810b,810c for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including an ultrasonic energy mode and an RF energy mode that can be delivered separately or simultaneously. Specifically, the drive signal outputs 810a,810 c may output an ultrasonic drive signal (e.g., a 420V Root Mean Square (RMS) drive signal) to the ultrasonic surgical instrument, and the drive signal outputs 810a,810 c may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument, where the drive signal output 810b corresponds to a center tap of the power transformer 806.
In some forms, the ultrasonic drive signal and the electrosurgical drive signal may be provided simultaneously to different surgical instruments and/or a single surgical instrument, such as a multi-functional surgical instrument, having the ability to deliver both ultrasonic energy and electrosurgical energy to tissue. It should be appreciated that the electrosurgical signal provided to the dedicated electrosurgical instrument and/or the combined multifunctional ultrasonic/electrosurgical instrument may be a therapeutic or sub-therapeutic level signal, wherein the sub-therapeutic signal may be used, for example, to monitor tissue or instrument conditions and provide feedback to the generator. For example, the ultrasound signal and the RF signal may be delivered separately or simultaneously from a generator having a single output port in order to provide the desired output signal to the surgical instrument, as will be discussed in more detail below. Thus, the generator may combine ultrasonic energy and electrosurgical RF energy and deliver the combined energy to the multi-functional ultrasonic/electrosurgical instrument. The bipolar electrode may be placed on one or both jaws of the end effector. In addition to electrosurgical RF energy, one jaw may be simultaneously driven by ultrasonic energy. Ultrasonic energy may be used to dissect tissue, while electrosurgical RF energy may be used for vascular sealing.
The non-isolated stage 804 may include a power amplifier 812, the power amplifier 812 having an output connected to a primary winding 814 of the power transformer 806. In some forms, the power amplifier 812 may include a push-pull amplifier. For example, the non-isolated stage 804 may also include logic device 816, which logic device 816 is configured to supply a digital output to a digital-to-analog converter (DAC) circuit 818, which DAC circuit 818 in turn supplies a corresponding analog signal to an input of the power amplifier 812. In some forms, for example, logic device 816 may include a Programmable Gate Array (PGA), an FPGA, a Programmable Logic Device (PLD), among other logic circuits. Thus, by controlling the input of power amplifier 812 via DAC circuit 818, logic device 816 may control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal that appears at drive signal outputs 810a, 810b, 810 c. In some forms and as described below, logic 816 in conjunction with a processor (e.g., a DSP described below) may implement a plurality of DSP-based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 800.
Power may be supplied to the power rail of the power amplifier 812 by a switch mode regulator 820 (e.g., a power converter). In some forms, the switch mode regulator 820 may comprise an adjustable buck regulator, for example. For example, the non-isolated stage 804 may also include a first processor 822, which in one form may include a DSP processor, such as Analog DEVICES ADSP-21469 SHARC DSP available from Analog Devices (Norwood, mass.), although any suitable processor may be employed in various forms. In some forms, DSP processor 822 may control the operation of switch mode regulator 820 in response to voltage feedback data received by DSP processor 822 from power amplifier 812 via ADC circuit 824. In one form, for example, DSP processor 822 may receive as input, via ADC circuit 824, the waveform envelope of the signal (e.g., RF signal) amplified by power amplifier 812. Subsequently, the DSP processor 822 can control the switch mode regulator 820 (e.g., via a PWM output) such that the rail voltage supplied to the power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 812 based on the waveform envelope, the efficiency of the power amplifier 812 may be significantly improved relative to a fixed rail voltage amplifier scheme.
In some forms, logic 816 in conjunction with DSP processor 822 may implement digital synthesis circuitry, such as a direct digital synthesizer control scheme, to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 800. In one form, for example, logic device 816 may implement the DDS control algorithm by recalling waveform samples stored in a dynamically updated look-up table (LUT) (such as a RAM LUT), which may be embedded in the FPGA. This control algorithm is particularly useful in ultrasound applications in which an ultrasound transducer, such as an ultrasound transducer, may be driven by a purely sinusoidal current at its resonant frequency. Minimizing or reducing the total distortion of the dynamic branch current may accordingly minimize or reduce adverse resonance effects, as other frequencies may excite parasitic resonances. Because the waveform shape of the drive signal output by the generator 800 is affected by various sources of distortion present in the output drive circuit (e.g., power transformer 806, power amplifier 812), the voltage and current feedback data based on the drive signal can be input into an algorithm (such as an error control algorithm implemented by DSP processor 822) that compensates for the distortion by pre-distorting or modifying the waveform samples stored in the LUT as appropriate in a dynamic traveling manner (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples may be dependent on the error between the calculated dynamic branch current and the desired current waveform shape, where the error may be determined on a sample-by-sample basis. In this manner, the predistorted LUT samples, when processed by the drive circuitry, may cause the dynamic arm drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such a form, when distortion effects are considered, the LUT waveform samples will not exhibit the desired waveform shape of the drive signal, but rather exhibit a waveform shape that requires the desired waveform shape of the dynamic arm drive signal to be ultimately produced.
The non-isolated stage 804 may also include first and second ADC circuits 826, 828 coupled to the output of the power transformer 806 via respective isolation transformers 830, 832 for sampling the voltage and current, respectively, of the drive signal output by the generator 800. In some forms, the ADC circuits 826, 828 may be configured to be capable of sampling at high speeds (e.g., 80 Million Samples Per Second (MSPS)) to enable oversampling of the drive signal. In one form, for example, the sampling rate of the ADC circuits 826, 828 may enable over-sampling of the drive signal by about 200x (depending on frequency). In some forms, the sampling operation of the ADC circuits 826, 828 may be performed by having a single ADC circuit receive the input voltage and current signals via a two-way multiplexer. By using high-speed sampling in the form of generator 800, among other things, computation of complex currents flowing through the dynamic legs (which in some forms may be used to achieve the above-described DDS-based waveform shape control), accurate digital filtering of the sampled signals, and computation of actual power consumption with high accuracy may be achieved. The voltage and current feedback data output by the ADC circuits 826, 828 may be received and processed (e.g., first-in-first-out (FIFO) buffers, multiplexers) by the logic device 816 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 822. As described above, the voltage and current feedback data can be used as inputs to the algorithm for pre-distorting or modifying LUT waveform samples in a dynamic progression manner. In some forms, when a pair of voltage and current feedback data is collected, it may be desirable to index each stored voltage and current feedback data based on or otherwise associated with a corresponding LUT sample output by logic device 816. Synchronizing LUT samples and voltage and current feedback data in this manner helps in the accurate timing and stability of the predistortion algorithm.
In some forms, voltage and current feedback data may be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signal. In one form, for example, voltage and current feedback data may be used to determine the impedance phase. Subsequently, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and the frequency control signal may be implemented in the DSP processor 822, for example, with the frequency control signal supplied as input to a DDS control algorithm implemented by the logic device 816.
In another form, the current feedback data may be monitored, for example, to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In some forms, control of the current amplitude may be achieved by a control algorithm in the DSP processor 822, such as, for example, a proportional-integral-derivative (PID) control algorithm. Variables that the control algorithm controls in order to properly control the current amplitude of the drive signal may include, for example: scaling of LUT waveform samples stored in logic device 816 and/or full scale output voltages via DAC circuit 818 of DAC circuit 834, which supplies the input to power amplifier 812.
The non-isolated stage 804 may also include a second processor 836 for providing, among other things, user Interface (UI) functionality. In one form, the UI processor 836 may include, for example, an Atmel AT91SAM9263 processor with ARM 926EJ-S core available from Atmel Corporation (San Jose, california). Examples of UI functions supported by UI processor 836 may include audible and visual user feedback, communication with peripheral devices (e.g., via a USB interface), communication with foot switches, communication with input devices (e.g., a touch screen display), and communication with output devices (e.g., speakers). The UI processor 836 may communicate with the DSP processor 822 and the logic device 816 (e.g., via an SPI bus). Although UI processor 836 may support primarily UI functions, in some forms it may also cooperate with DSP processor 822 to mitigate risk. For example, the UI processor 836 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen input, foot switch input, temperature sensor input) and may deactivate the drive output of the generator 800 upon detection of an error condition.
In some forms, for example, both DSP processor 822 and UI processor 836 may determine and monitor an operational state of generator 800. For DSP processor 822, the operating state of generator 800 may, for example, indicate which control and/or diagnostic processes DSP processor 822 implements. For UI processor 836, the operational state of generator 800 may indicate, for example, which elements of the UI (e.g., display, sound) are presented for the user. The respective DSP processors 822 and UI processor 836 may independently maintain the current operating state of the generator 800 and identify and evaluate possible transitions of the current operating state. DSP processor 822 may act as the subject in this relationship and determine when a transition between operating states will occur. The UI processor 836 may note the valid transitions between operating states and may confirm whether a particular transition is appropriate. For example, when DSP processor 822 instructs UI processor 836 to transition to a particular state, UI processor 836 may verify that the requested transition is valid. If the UI processor 836 determines that the required inter-state transition is invalid, the UI processor 836 may cause the generator 800 to enter a failure mode.
The non-isolated stage 804 may also include a controller 838 for monitoring input devices (e.g., capacitive touch sensors, capacitive touch screens for turning the generator 800 on and off). In some forms, the controller 838 may include at least one processor and/or other control device in communication with the UI processor 836. In one form, for example, the controller 838 may include a processor (e.g., a Mega168 bit controller from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one form, the controller 838 may include a touch screen controller (e.g., QT5480 touch screen controller available from Atmel) to control and manage the acquisition of touch data from a capacitive touch screen.
In some forms, the controller 838 may continue to receive operating power (e.g., via a line from a power source of the generator 800, such as the power source 854 described below) while the generator 800 is in the "power off" state. In this manner, the controller 838 may continue to monitor an input device (e.g., a capacitive touch sensor located on the front panel of the generator 800) for turning the generator 800 on and off. When the generator 800 is in a power off state, the controller 838 may wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 856 of the power source 854) if user activation of an "on/off" input device is detected. The controller 838 may thus begin a sequence that transitions the generator 800 to the "power on" state. Conversely, when the generator 800 is in the power on state, if activation of the "on/off input device is detected, the controller 838 may begin a sequence that transitions the generator 800 to the power off state. In some forms, for example, the controller 838 may report activation of an "on/off" input device to the UI processor 836, which in turn implements a desired sequence of processes to transition the generator 800 to a power-off state. In such forms, the controller 838 may not have the independent ability to remove power from the generator 800 after the power-on state is established.
In some forms, the controller 838 may cause the generator 800 to provide audible or other sensory feedback to alert the user that a power-on or power-off sequence has begun. Such alerts may be provided at the beginning of a power-on or power-off sequence and prior to the beginning of other processes associated with the sequence.
In some forms, isolation stage 802 may include instrument interface circuitry 840, for example, to provide a communication interface between control circuitry of the surgical instrument (e.g., control circuitry including a handpiece switch) and components of non-isolation stage 804, such as, for example, logic device 816, DSP processor 822, and/or UI processor 836. The instrument interface circuit 840 may exchange information with components of the non-isolated stage 804 via a communication link (such as, for example, an IR-based communication link) that maintains a suitable degree of electrical isolation between the isolated stage 802 and the non-isolated stage 804. For example, instrument interface circuit 840 may be powered using a low drop-out voltage regulator powered by an isolation transformer, which is driven from non-isolation stage 804.
In one form, instrument interface circuit 840 may include logic 842 (e.g., logic, programmable logic, PGA, FPGA, PLD) in communication with signal-conditioning circuit 844. The signal conditioning circuit 844 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the logic circuit 842 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signals may be sent to the surgical instrument control circuit (e.g., through the use of conductive pairs in a cable connecting the generator 800 to the surgical instrument) and monitored to determine the status or configuration of the control circuit. The control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that a state or configuration of the control circuit may be uniquely identified based on the one or more characteristics. In one form, for example, the signal conditioning circuit 844 may include an ADC circuit for generating samples of a voltage signal that appears in the control circuit input as a result of an interrogation signal passing through the control circuit. Subsequently, the logic circuit 842 (or a component of the non-isolation stage 804) may determine a state or configuration of the control circuit based on the ADC circuit samples.
In one form, instrument interface circuit 840 may include a first data circuit interface 846 to enable exchange of information between logic circuit 842 (or other elements of instrument interface circuit 840) and first data circuits provided in or otherwise associated with a surgical instrument. In some forms, for example, the first data circuit may be provided in a cable integrally attached to the surgical instrument handpiece, or in an adapter for interfacing a particular surgical instrument type or model with the generator 800. The first data circuit may be implemented in any suitable manner and may communicate with the generator according to any suitable protocol including, for example, those described herein with respect to the first data circuit. In some forms, the first data circuit may include a non-volatile memory device, such as an EEPROM device. In some forms, the first data circuit interface 846 may be implemented separately from the logic circuit 842 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 may be integral with the logic circuit 842.
In some forms, the first data circuit may store information related to the particular surgical instrument associated therewith. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information. Such information may be read by instrument interface circuit 840 (e.g., by logic circuit 842), transmitted to components of non-isolated stage 804 (e.g., to logic device 816, DSP processor 822, and/or UI processor 836) for presentation to a user via an output device and/or to control functions or operations of generator 800. In addition, any type of information may be sent to the first data circuit via the first data circuit interface 846 (e.g., using logic circuit 842) for storage therein. Such information may include, for example, an updated number of operations in which the surgical instrument is used and/or a date and/or time of its use.
As previously discussed, the surgical instrument may be detachable from the handpiece (e.g., the multi-function surgical instrument may be detachable from the handpiece) to facilitate instrument interchangeability and/or disposability. In such cases, the ability of the conventional generator to identify the particular instrument configuration used and to optimize the control and diagnostic process accordingly may be limited. However, from a compatibility perspective, it is problematic to address this problem by adding readable data circuits to the surgical instrument. For example, designing a surgical instrument to maintain backward compatibility with a generator lacking the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and costs. The form of instrument described herein addresses these problems by using data circuits that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical instrument with the current generator platform.
In addition, the form of the generator 800 may enable communication with an instrument-based data circuit. For example, the generator 800 may be configured to communicate with a second data circuit included in an instrument (e.g., a multifunction surgical instrument). In some forms, the second data circuit may be implemented in a manner similar to the first data circuit described herein. The instrument interface circuit 840 may include a second data circuit interface 848 for enabling this communication. In one form, the second data circuit interface 848 may comprise a tri-state digital interface, although other interfaces may be used. In some forms, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one form, for example, the second data circuit may store information related to the particular surgical instrument associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information.
In some forms, the second data circuit may store information regarding electrical and/or ultrasonic characteristics of an associated ultrasonic transducer, end effector, or ultrasonic drive system. For example, the first data circuit may indicate an aging frequency slope, as described herein. Additionally or alternatively, any type of information may be sent to the second data circuit for storage therein via the second data circuit interface 848 (e.g., using the logic circuit 842). Such information may include, for example, the number of updates to the operation in which the surgical instrument was used and/or the date and/or time of its use. In some forms, the second data circuit may transmit data collected by one or more sensors (e.g., instrument-based temperature sensors). In some forms, the second data circuit may receive data from the generator 800 and provide an indication (e.g., a light emitting diode indication or other visual indication) to the user based on the received data.
In some forms, the second data circuit and the second data circuit interface 848 may be configured such that communication between the logic circuit 842 and the second data circuit may be accomplished without providing additional conductors for this (e.g., dedicated conductors of a cable connecting the handpiece to the generator 800). In one form, for example, information may be sent to and from the second data circuit using a single bus communication scheme implemented on an existing cable, such as one of the conductors for transmitting interrogation signals from the signal conditioning circuit 844 to the control circuit in the handpiece. In this way, design changes or modifications of the surgical instrument that may otherwise be necessary may be minimized or reduced. Furthermore, because the different types of communications implemented on the common physical channel may be band separated, the presence of the second data circuit may be "stealth" to the generator that does not have the requisite data reading functionality, thus enabling backward compatibility of the surgical instrument.
In some forms, the isolation stage 802 may include at least one blocking capacitor 850-1, the at least one blocking capacitor 850-1 being connected to the drive signal output 810b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although relatively few failures occur in single capacitor designs, such failures can have adverse consequences. In one form, a second blocking capacitor 850-2 may be provided in series with blocking capacitor 850-1, wherein current leakage occurring from a point between blocking capacitors 850-1 and 850-2 is monitored, such as by ADC circuit 852, to sample the voltage induced by the leakage current. These samples may be received, for example, by logic 842. Based on the change in leakage current (as indicated by the voltage samples), the generator 800 can determine when at least one of the blocking capacitors 850-1, 850-2 fails, thus providing benefits over a single capacitor design with a single point of failure.
In some forms, non-isolated stage 804 may include a power source 854 for delivering DC power at a suitable voltage and current. The power source may comprise, for example, a 400W power source for delivering a DC system voltage of 48V. The power source 854 may also include one or more DC/DC voltage converters 856 for receiving an output of the power source to generate a DC output at voltages and currents required by the various components of the generator 800. As described above in connection with the controller 838, one or more of the DC/DC voltage converters 856 may receive input from the controller 838 when the controller 838 detects a user activation of an "on/off" input device to enable operation of the DC/DC voltage converter 856 or to wake up the DC/DC voltage converter 856.
Fig. 21 shows an example of a generator 900, which is one form of generator 800 (fig. 20). Generator 900 is configured to deliver a plurality of energy modalities to a surgical instrument. Generator 900 provides an RF signal and an ultrasonic signal for delivering energy to the surgical instrument independently or simultaneously. The RF signal and the ultrasonic signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to an end effector to treat tissue.
Generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to be able to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which is not shown for clarity of this disclosure. The digital information associated with the waveform is provided to a waveform generator 904, which waveform generator 904 includes one or more DAC circuits to convert the digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled to a secondary side of the patient isolated sides through a power transformer 908. A first signal of a first ENERGY modality is provided to the surgical instrument between terminals labeled enable 1 and RETURN. A second signal of a second ENERGY modality is coupled across capacitor 910 and provided to the surgical instrument between terminals labeled enable 2 and RETURN. It should be appreciated that more than two energy modes may be output, and thus the subscript "n" may be used to designate that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1. It should also be appreciated that up to "n" return paths RETURNn may be provided without departing from the scope of the present disclosure.
The first voltage sensing circuit 912 is coupled across terminals labeled enable 1 and RETURN paths to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across terminals labeled enable 2 and RETURN paths to measure the output voltage therebetween. As shown, a current sensing circuit 914 is provided in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. The outputs of the first and second voltage sensing circuits 912, 924 are provided to respective isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to the other isolation transformer 918. The output of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolated side) is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. Output voltage and output current feedback information may be used to adjust the output voltage and current provided to the surgical instrument and calculate output impedance, among other parameters. Input/output communications between the processor 902 and patient isolation circuitry are provided through interface circuitry 920. The sensor may also be in electrical communication with the processor 902 through the interface 920.
In one aspect, the impedance may be determined by the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled across a terminal labeled enable 1/RETURN or a second voltage sensing circuit 924 coupled across a terminal labeled enable 2/RETURN by the output of a current sensing circuit 914 disposed in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage sensing circuits 912, 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to the other isolation transformer 916. The digitized voltage and current sense measurements from ADC circuit 926 are provided to processor 902 for use in calculating impedance. For example, the first ENERGY modality enegy 1 may be ultrasonic ENERGY and the second ENERGY modality enegy 2 may be RF ENERGY. However, other energy modes besides ultrasound and bipolar or monopolar RF energy modes include irreversible and/or reversible electroporation and/or microwave energy, and the like. Moreover, while the example shown in fig. 21 illustrates that a single RETURN path RETURN may be provided for two or more energy modalities, in other aspects, multiple RETURN paths RETURNn may be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.
As shown in fig. 21, a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in one or more energy modes (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, generator 900 may deliver energy with a higher voltage and a lower current to drive an ultrasound transducer, a lower voltage and a higher current to drive an RF electrode for sealing tissue, or a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasound transducer to the output of generator 900 will preferably be between the outputs labeled ENERGY 1 and RETURN, as shown in FIG. 21. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be between outputs labeled enable 2 and RETURN. In the case of monopolar output, the preferred connection would be an active electrode (e.g., a cone of light (pencil) or other probe) to the appropriate RETURN pad of the ENERGY 2 output and to the RETURN output.
Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled technique (TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS) for operating a generator and housing instrument for digitally generating electrical signal waveforms, published at 30/3/2017, which is incorporated herein by reference in its entirety.
Fig. 22 illustrates an electrosurgical system 60000 in accordance with at least one aspect of the present disclosure. Electrosurgical system 60000 includes a generator 60002, electrosurgical instrument 60004, and return pad 60006. The generator 60002 supplies an alternating current at radio frequency level to the electrosurgical instrument 60004 via the first conductor/cable 60008. The electrosurgical instrument 60004 includes an electrode tip (i.e., an active electrode) positionable at a target tissue of a patient. The electrosurgical instrument 60004 receives alternating current from the generator 60002 and delivers the alternating current to target tissue of the patient 60010 via the electrode tip. The alternating current is received at the target tissue and the electrical resistance from the tissue generates heat that provides the desired effect (e.g., sealing and/or cutting) at the surgical site. The alternating current is conducted through the patient's body and ultimately received by return pad 60006. The alternating current received by the return pad 60006 is carried back to the generator 60002 via the second conductor/cable 60012 to complete the closed path followed by the alternating current.
According to various aspects, the generator 60002 is similar to the generator 900 described above, and may include, for example, a processor and a waveform generator similar to the processor 902 and the waveform generator 904 described above.
The electrosurgical instrument 60004 may be configured for monopolar operation, wherein electrosurgical energy supplied by the generator 60002 is introduced into the patient's tissue through the active electrode of the surgical instrument 60004 and returned to the generator 60002 via a return pad 6006. According to various aspects, the electrosurgical instrument 60004 includes a handpiece or light cone and an electrode tip. The electrode tip acts as an active electrode for the electrosurgical system 60000 and introduces electrosurgical energy into the target tissue of the patient 60010. Specifically, an electrical discharge is delivered from the electrode tip to the patient 60010 in order to cause heating of cellular material of the patient 60010 in close contact with or adjacent to the electrode tip. Tissue heating occurs at a suitably high temperature to allow the electrosurgical instrument 60004 to be used to perform electrosurgery.
Fig. 23 illustrates a return pad 60006 of the electrosurgical system 60000 of fig. 22 in accordance with at least one aspect of the present disclosure. The return pad 60006 is with a MEGA commercially available from Megadyne medical Products (MEGADYNE MEDICAL Products, inc.)The patient return electrode may be similar in that the return pad 60006 may comprise a sleeve or cover 60014, may be separated from the patient's body by a small distance, may be capacitively coupled to the patient's body, and is configured to be able to carry the amount of current introduced into the patient's body by the electrosurgical instrument 60004, but differently.
The return pad 60006 is with a MEGA commercially available from Megadyne medical Products (MEGADYNE MEDICAL Products, inc.)The patient return electrode differs in that, instead of one return electrode, the return pad includes a plurality of electrodes 60016 (see fig. 24) that can be capacitively coupled to the patient's body and collectively configured to be able to carry the amount of current introduced into the patient's body by the electrosurgical instrument 60004. For such capacitive coupling, the patient's body effectively acts as one plate of the capacitor, and the multiple electrodes of the return pad together effectively act together as the other plate of the capacitor. A more detailed description of capacitive coupling can be found in, for example, U.S. patent No. 6,214,000 entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE" issued 10/4/2001 and U.S. patent No. 6,582,424 entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE" issued 24/6/2003, each of which is incorporated by reference in its entirety. Although return pad 60006 is shown in fig. 23 as being generally rectangular, it should be appreciated that return pad 60006 may be any suitable shape.
Fig. 24 illustrates a plurality of electrodes 60016 of the return pad 60006 of fig. 23 in accordance with at least one aspect of the present disclosure. For clarity, the sleeve or cover 60014 of the return pad 60006 is not shown in fig. 24. Although four electrodes 60016 are shown in fig. 24, it should be understood that return pad 60006 can include any number of electrodes 60016. For example, according to various aspects, return pad 60006 includes sixteen electrodes 60016. Moreover, although individual electrodes 60016 are shown as being generally rectangular in fig. 24, it should be appreciated that individual electrodes may be of any suitable shape.
The electrode 60016 of the return pad 60006 can be considered a return electrode of the electrosurgical system 60000 of fig. 22, and can also be considered a segmented electrode, as the electrode 60016 can be selectively decoupled from the patient's body and/or the generator 60002. The electrodes 60016 of return pad 60006 can also be coupled together to effectively act as one large electrode. For example, according to various aspects, each of the electrodes 60016 of the return pad 60006 can be connected to an input of the switching device 60020 by a respective conductive member 60018, as shown in fig. 24. When the switching device 60020 is in the open position as shown in fig. 24, the respective electrodes 60016 of the return pads 60006 are decoupled from each other and from the patient's body and/or the generator 60002. In contrast, when the switching device 60020 is in the closed position, the respective electrodes 60016 of the return pads 60006 are coupled together to effectively act as one large electrode.
The switching device 60020 may be controlled by processing circuitry (e.g., processing circuitry of the generator 60002 of the electrosurgical system, processing circuitry of the surgical hub 206, processing circuitry of the surgical hub 106, etc.). For simplicity, the processing circuitry is not shown in fig. 24. According to various aspects, the switching device 60020 shown in fig. 24 can be incorporated into the return pad 60006. According to other aspects, the switching device 60006 shown in fig. 24 may be incorporated into the second conductor/cable 60012 of the electrosurgical system 60000 of fig. 22. The return pad 60006 may also include a plurality of sensing means 60022 (see figure 25).
By being able to couple multiple electrodes 60016 together for use during an electrosurgical procedure, the overall effective size of the electrodes 60016 of the return pad 60006 is sufficiently large and/or has sufficient surface area to keep the current density low enough to mitigate the likelihood of any unnecessary burn of the patient 60010.
Fig. 25 illustrates an array of sensing devices 60022 of the return pad 60006 of fig. 23, in accordance with at least one aspect of the present disclosure. For clarity, the sleeve or cover 60014 of the return pad 60006 is not shown in fig. 25. According to various aspects, the number of sensing devices 60022 corresponds to the number of electrodes 60016 such that there is one sensing device 60022 per electrode 60016, and each sensing device 60022 is mounted to or integrated with a corresponding electrode 60016. However, although the number of sensing devices 60022 shown in fig. 25 corresponds to the number of electrodes 60016, it should be appreciated that return pads 60006 can include any number of sensing devices 60022. For example, for aspects of the return pad 60006 that include sixteen electrodes 60016, the return pad 60006 may include only four or eight sensing means 60022. Although the sensing device 60022 is shown in fig. 25 as being centered on a corresponding electrode 60016, it should be understood that the sensing device 60022 may be positioned on any portion of the corresponding electrode 60016 and may be positioned differently on different electrodes 60016.
The sensing device 60022 is configured to be able to detect monopolar nerve control signals applied to a patient and/or movement of anatomical features of the patient (e.g., muscle twitches) caused by application of the nerve control signals. The monopolar nerve control signal may be applied by the electrosurgical instrument 60004 of the electrosurgical system 60000 of fig. 22, or may be applied by a different surgical instrument coupled to a different generator. Each sensing device 60022 may include, for example, a pressure sensor, an accelerometer, combinations thereof, or the like, and is configured to output signals indicative of detected nerve control signals and/or detected movement of anatomical features of the patient. Such pressure sensors may include, for example, piezoresistive strain gauges, capacitive pressure sensors, electromagnetic pressure sensors, and/or piezoelectrical pressure sensors. Such accelerometers may include, for example, mechanical accelerometers, capacitive accelerometers, piezoelectric accelerometers, electromagnetic accelerometers, and/or microelectromechanical system (MEMS) accelerometers. The respective output signals of the respective sensing means 60022 may be in the form of analog signals and/or digital signals.
Using coulomb's law and the respective positions of the active electrodes of the electrosurgical instrument 60004, the patient's body, and the respective sensing devices 60022, the respective output signals of the respective sensing devices 60022, which are indicative of the detected nerve control signals and/or movement of anatomical features of the patient, may be analyzed to determine the position of the nerve within the patient's body. Coulomb's law states that e=k (Q/r 2), where E is the threshold current required to stimulate a nerve at the nerve, K is a constant, Q is the minimum current from the nerve stimulating electrode, and r is the distance from the nerve. The farther the nerve stimulating electrode is from the nerve, the proportionally greater the current required to stimulate the nerve. Thus, constant current stimulation may be utilized to estimate the distance from the nerve stimulating electrode to the nerve. In general, the respective intensity of the output signal of the respective sensing device 60022 indicates how close or far the respective sensing device 60022 is to the stimulated nerve of the patient 60010.
According to various aspects, analysis of the respective output signals of the respective sensing devices 60022 may be performed by processing circuitry of the generator 60002 of the electrosurgical system 60000 of fig. 22, by processing circuitry of a nerve monitoring system separate from the generator 60002 of the electrosurgical system 60000 of fig. 22, by processing circuitry of the surgical hub 206, by processing circuitry of the surgical hub 106, and so forth. The analysis may be performed in real time or near real time. According to various aspects, the respective output signals are used as inputs to a monopolar nerve stimulation algorithm executed by the processing circuit.
As shown in fig. 25, according to various aspects, the output signals of the respective sensing devices 60022 may be input into a multiple-input-single-output switching device 60024 (e.g., a multiplexer) via the respective conductive members 60026. By controlling the selection signal S 0、S1 to the multiple-input-single-output switching device 60024, the multiple-input-single-output switching device 60024 can be controlled to output only one of the output signals of the respective sensing devices 60024 at a time for the analysis described above. For example, referring to fig. 25, by setting the select signals S 0、S1 to 0, the output signal from the sensing device 60022 associated with the electrode 60016 in the upper left corner of fig. 25 can be output by the multiple-input-single-output switching device 60024 for analysis by applicable processing circuitry. By setting the selection signal S 0、S1 to 0, 1, the output signal from the sensing device 60022 associated with the electrode 60016 in the upper right hand corner of fig. 25 can be output by the multiple-input-single-output switching device 60024 for analysis by applicable processing circuitry. By setting the selection signal S 0、S1 to 1, 0, the output signal from the sensing device 60022 associated with the electrode 60016 in the lower left corner of fig. 25 can be output by the multiple-input-single-output switching device 60024 for analysis by applicable processing circuitry. By setting the selection signal S 0、S1 to 1, the output signal from the sensing device 60022 associated with the electrode 60016 in the lower right hand corner of fig. 25 can be output by the multiple-input-single-output switching device 60024 for analysis by applicable processing circuitry.
The selection signal S 0、S1 may be provided to the multiple-input-single-output switching device 60024 by a processing circuit, such as the processing circuit of the generator 60002 of the electrosurgical system 60000 of fig. 22, the processing circuit of a nerve monitoring system separate from the generator 60002 of the electrosurgical system 60000 of fig. 22, the processing circuit of the surgical hub 206, the processing circuit of the surgical hub 106, or the like. For simplicity, the processing circuitry is not shown in fig. 25. By providing the various selection signals at a sufficiently fast rate, the rate at which all of the output signals of the respective sensing devices are analyzed in time may be allowed to effectively scan the output signals of the respective sensing devices to determine the location of the stimulated nerve.
According to various aspects, the multiple-input-single-output switching device 60024 shown in fig. 25 can be incorporated into the return pad 60006. According to other aspects, the multiple-input-single-output switching device 60024 shown in fig. 25 can be incorporated into the second conductor/cable 60012 of the electrosurgical system 60000 of fig. 22.
The control of the multiple input-single output switching device 60024 is described above in the context of a four input-single output switching device corresponding to the four sensing devices 60022 shown in fig. 25. It will be appreciated that for aspects where there are more than four sensing devices 60022 (e.g., sixteen sensing devices), the output signals of more than four sensing devices 60022 will be input to the multiple-input-single-output switching device 60024, and more than two select signals (e.g., S 0、S1、S2 and S 3) are required to control the output of the multiple-input-single-output switching device 60024.
For the aspect that the output signal of the sensing device 60024 is an analog signal, the output of the multiple-input-single-output switching device 60024 may be converted to a corresponding digital signal by an analog-to-digital converter 60026 (shown as a dashed line in fig. 25) before analysis of the output signal is performed by an applicable processing circuit.
By incorporating an array of sensing devices 60022 into the plurality of electrodes 60016 of return pad 60006, the position of a patient's nerve relative to the electrode tips of electrosurgical instrument 60004 can be determined. The determined nerve position may be presented to the surgeon, thereby reducing the likelihood that the surgeon will inadvertently damage or sever the nerve when cutting target tissue of patient 60010 with the electrode tip.
According to various aspects, detection of the nerve control signal and/or movement of an anatomical feature of the patient by the sensing device 60022 may be performed when the electrodes 60016 of the return pad 60006 are coupled to one another or when the electrodes 60016 are decoupled from one another. For example, with respect to performing detection when the respective electrodes 60016 of the return pad 60006 are decoupled from each other, the return pad 60006 can be placed in a "sensing mode" after positioning the patient 60010 on an operating table but before starting a surgical procedure by controlling the switching means 60020 shown in fig. 24 to decouple the respective electrodes 60016 of the return pad 60006 from each other. When the respective electrodes 60016 are decoupled from each other, the nerve and/or nerve bundles may be stimulated with the electrosurgical instrument 60004 as described above, and the respective output signals of the sensing means 60022 of the return pad 60006 may be analyzed as described above to identify where the nerve, nerve bundles, and/or nerve junctions associated therewith are located. These locations may be input into a monopolar nerve stimulation algorithm curve, which may reside, for example, in a memory circuit of the generator 60002, a memory circuit coupled to a different generator of a surgical instrument other than the electrosurgical instrument 60004, and so forth. Once these locations are entered into the monopolar neural stimulation algorithm curve, they are effectively isolated from the capacitive operation of the electrode 60016 of the return pad 60006 and serve as sensing nodes of the monopolar neural stimulation algorithm curve to inform the surgeon when approaching the nerve and/or nerve bundles when performing a tissue cutting procedure. According to various aspects, the surgeon may be notified of the nearby location of the nerve and/or nerve bundle via an audible alert, visual alert, vibratory alert, or the like.
With respect to performing the detection when the respective electrodes 60016 of the return pads 60006 are coupled to one another, according to various aspects, as described in more detail below with reference to fig. 26, the generator 60002 of the electrosurgical system 60000 of fig. 22 can generate a high frequency waveform (radio frequency alternating current) modulated on a carrier wave, wherein the carrier wave has a frequency low enough to stimulate the nerve of the patient. This allows sensing of the nerve control signal and/or movement of anatomical features to occur simultaneously with capacitive coupling of the corresponding electrode 60016 of the return pad 60006 to the patient's body. By applying a specific waveform to the patient 60010 and sensing a specific response, it is highly confident that the movement of the anatomical feature is the result of the applied waveform and not just some general movement. The modulation scheme may be adjusted over time to stimulate different sizes of nerves. According to various aspects, the modulation may vary in amplitude over time in order to allow an applicable processing circuit to determine the distance of the nerve and/or nerve bundle from the signal without having to constantly stimulate the nerve and/or nerve bundle.
Fig. 26 illustrates a method 60030 for simultaneously applying a neural stimulation signal and electrosurgical energy to a patient in accordance with at least one aspect of the present disclosure. As a first step 60032 in the exemplary process, the generator 60002 generates an alternating current at a radio frequency level as a high frequency waveform. According to various aspects, the waveform generator of the generator 60002 performs this step.
For the second step 60034, the generator 60002 generates a low-frequency waveform configured to be able to stimulate the nerve of the patient. According to various aspects, the low frequency waveform is a unipolar nerve control signal, and the waveform generator of the generator 60002 performs this step.
For the third step 60036, the generator 60002 modulates the low frequency waveform generated at step 60034 with the high frequency waveform generated at step 60032 to form a composite waveform. According to various aspects, the waveform generator of the generator 60002 performs this step. According to other embodiments, the processing circuitry of the generator 60002 performs this step.
For a fourth step 60038, the generator 60002 supplies the composite waveform generated at step 60036 to the electrosurgical instrument 60004.
For the fifth step 60040, the electrode of the electrosurgical instrument 60004 (i.e., the active electrode) applies the composite waveform to the patient 60010. The high frequency waveform is used to heat the target tissue of the patient 60010 and leaves the patient's body and is then received by the electrode 60016 of the return pad 60006. The low frequency waveforms are used to stimulate the patient's nerves and/or cause movement (e.g., muscle twitches) of the patient's anatomical features caused by the application of nerve control signals.
For the sixth step 60042, a plurality of electrodes 60016 coupled together via a switching means 60020 receive electrosurgical energy exiting the patient's body and transfer the electrosurgical energy back to the generator 60002 through the respective conductive members 60018, switching means 60020 and second conductors/cables 60012.
For the seventh step 60044, the sensing means 60022 detects the unipolar nerve control signal applied to the patient 60010 and/or the movement of anatomical features of the patient 60010 caused by the application of the nerve control signal (e.g., muscle twitches) and generates a respective output signal corresponding thereto. The output of the respective sensing means 60022 is sampled as described above and forwarded to processing circuitry for analysis. The processing circuitry may be, for example, the processing circuitry of the generator 60002 of the electrosurgical system 60000 of fig. 22, the processing circuitry of a nerve monitoring system separate from the generator 60002 of the electrosurgical system 60000 of fig. 22, the processing circuitry of the surgical hub 206, the processing circuitry of the surgical hub 106, and the like.
For the eighth step 60046, the applicable processing circuitry analyzes the output signal and determines where the nerve, nerve bundle, and/or nerve connection associated with the output signal is located. As described above, according to various aspects, the respective output signals may be used as inputs to a monopolar nerve stimulation algorithm performed by the processing circuit, and the monopolar nerve stimulation algorithm is used to help prevent a surgeon from cutting or damaging nerves, nerve bundles, and/or nerve junctions.
Examples
Various aspects of the subject matter described herein are set forth in the following numbered embodiments.
Example 1-a return pad for an electrosurgical system, the return pad comprising: a plurality of conductive members configured to receive radio frequency current applied to a patient; and a plurality of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal.
Embodiment 2-the return pad of embodiment 1, wherein the plurality of conductive members are further configured for capacitive coupling with a patient.
Embodiment 3-the return pad of any of embodiments 1-2, further comprising a switching device configured to selectively decouple at least one of the plurality of conductive members from another of the plurality of conductive members.
Embodiment 4-the return pad of any one of embodiments 1-3, further comprising a switching device configured to selectively decouple each of the conductive members from another conductive member.
Embodiment 5-the return pad of any of embodiments 1-4, further comprising a switching device configured to selectively decouple the plurality of conductive members from the patient.
Embodiment 6-the return pad of any of embodiments 1-5, further comprising a switching device configured to selectively decouple the plurality of conductive members from the generator.
Embodiment 7-the return pad of any one of embodiments 1-6, further comprising a switching device configured to selectively couple each of the plurality of conductive members to the generator.
Embodiment 8-the return pad of any of embodiments 1-7, wherein the plurality of sensing devices is configured as an array of sensing devices.
Embodiment 9-the return pad of any of embodiments 1-8, wherein each sensing device of the plurality of sensing devices is coupled to a corresponding one of the plurality of conductive members.
Embodiment 10-the return pad of any one of embodiments 1-9, wherein each conductive member of the plurality of conductive members is coupled to a corresponding one of the plurality of sensing devices.
Embodiment 11-the return pad of any one of embodiments 1-10, wherein at least one sensing device of the plurality of sensing devices comprises one of: a pressure sensor; an accelerometer; pressure sensors and accelerometers.
Embodiment 12-the return pad of any one of embodiments 1-11, wherein each of the plurality of sensing devices is further configured to be capable of outputting a signal indicative of detection.
Example 13-an electrosurgical system, comprising: a generator configured to be capable of supplying a radio frequency alternating current; an instrument configured to apply an alternating current to a patient; a return pad capable of capacitively coupling to a patient, wherein the return pad comprises: a plurality of conductive members configured to conduct radio frequency current, wherein the plurality of conductive members are capacitively coupleable to the patient and selectively coupleable to the generator; a plurality of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal; and a conductor coupled to the return pad and the generator.
Embodiment 14-the electrosurgical system of embodiment 13, further comprising a multiple-input-single-output switching device coupled to each of the plurality of sensing devices.
Embodiment 15-the electrosurgical system of embodiment 14, further comprising an analog-to-digital converter coupled to the multiple-input-single-output switching device.
Embodiment 16-the electrosurgical system of any one of embodiments 1-15, wherein the generator is further configured to: generating an alternating current as a high frequency waveform; generating a low frequency waveform configured to stimulate a nerve of a patient; modulating the low frequency waveform with the high frequency waveform to form a composite waveform; and supplying the composite waveform to the instrument.
Embodiment 17-the electrosurgical system of any of embodiments 1-16, wherein the generator is further configured to amplitude modulate the low frequency waveform to form a composite waveform.
Example 18-a return pad for an electrosurgical system, the return pad comprising: a plurality of electrodes configured for capacitive coupling with a patient; and an array of sensing devices configured to be capable of detecting at least one of: a nerve control signal applied to the patient; and movement of anatomical features of the patient caused by application of the nerve control signal.
Embodiment 19-the return pad of embodiment 18, wherein each sensing device in the array of sensing devices is configured to be capable of outputting a signal indicative of detection.
Embodiment 20-the return pad of any of embodiments 18-19, wherein each sensing device of the array of sensing devices is positioned on a corresponding one of the plurality of electrodes.
While various forms have been illustrated and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such detail. Many modifications, variations, changes, substitutions, combinations, and equivalents of these forms may be made by one skilled in the art without departing from the scope of the disclosure. Furthermore, the structure of each element associated with the described form may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may be used. It is, therefore, to be understood that the foregoing detailed description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms of the invention. The appended claims are intended to cover all such modifications, changes, variations, substitutions, modifications and equivalents.
The foregoing detailed description has set forth various forms of the apparatus and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein may be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and/or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product or products in a variety of forms, and that an illustrative form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.
Instructions for programming logic to perform the various disclosed aspects can be stored within a memory within a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include, but is not limited to, a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), a floppy disk, an optical disk, a compact disk, a read-only memory (CD-ROM), a magneto-optical disk, a read-only memory (ROM), a Random Access Memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic or optical card, a flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not mean that the associated organizations do not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including, but not limited to, wi-Fi (IEEE 802.11 family), wiMAX (IEEE 802.16 family), IEEE 802.20, long Term Evolution (LTE), ev-DO, hspa+, hsdpa+, hsupa+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, bluetooth, and ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, wiMAX, LTE, ev-DO, etc.
As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), programmable Logic Arrays (PLAs), field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware storing instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry forming part of a larger system, such as an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smart phone, or the like. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially implements the methods and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially implements the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, communication switch, or optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.
As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (typically memory or some other data stream). The term as used herein refers to a central processor (central processing unit) in one or more systems, especially a system on a chip (SoC), that combine multiple specialized "processors".
As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the components of a computer or other electronic system. It may contain digital, analog, mixed signal and typically radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripheral devices such as a Graphics Processing Unit (GPU), wi-Fi module, or coprocessor. The SoC may or may not contain built-in memory.
As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its components. The microcontroller may include one or more Core Processing Units (CPUs), memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory or OTP ROM, as well as small amounts of RAM are often included on the chip. Microcontrollers may be used in embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.
As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between two components of a computer or a controller on an external device for managing the operation of (and connection to) the device.
Any of the processors or microcontrollers as described herein may be any single or multi-core processor, such as those provided by texas instruments company (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from texas instruments (Texas Instruments), comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load STELLARISInternal read-only memory (ROM) of software, electrically erasable programmable read-only memory (EEPROM) of 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features that are readily available.
In one example, the processor may include a security controller that includes two controller-based families, such as TMS570 and RM4x, also offered by texas instruments (Texas Instruments) under the trade name Hercules ARM Cortex R4. The security controller may be configured to be capable of being dedicated to IEC 61508 and ISO 26262 security critical applications, etc., to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.
As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer readable storage medium. The firmware may be embodied as code, instructions or a set of instructions and/or data that are hard-coded (e.g., non-volatile) in a storage device.
As used in any aspect herein, the terms "component," "system," "module," and the like can refer to a computer-related entity, hardware, a combination of hardware and software, or software in execution.
As used in any aspect herein, an "algorithm" refers to an organized sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states that may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. Are often used to refer to signals such as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or conditions.
The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow for communication using transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with an ethernet standard known as the "IEEE 802.3 standard" published by the Institute of Electrical and Electronics Engineers (IEEE) at month 12 of 2008 and/or a higher version of the standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunications union telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard promulgated by the ATM forum at month 8 of 2001 under the name "ATM-MPLS network interworking 2.0" and/or a higher version of the standard. Of course, different and/or later developed connection oriented network communication protocols are likewise contemplated herein.
Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
One or more components may be referred to herein as "configured to be capable of", "configurable to be capable of", "operable/operable", "adapted/adaptable", "capable of", "conformable/conformable", and the like. Those skilled in the art will recognize that "configured to be capable of" may generally encompass active and/or inactive and/or standby components unless the context indicates otherwise.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It will also be appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "upper," "lower," "left," and "right" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
The modular device includes modules receivable within a surgical hub (as described in connection with fig. 3 and 9) and a surgical device or instrument that is connectable to various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, aspiration/irrigation devices, smoke ventilators, energy generators, ventilators, insufflators, and displays. The modular device described herein may be controlled by a control algorithm. The control algorithm may be executed on the modular device itself, on a surgical hub paired with a particular modular device, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., through sensors in, on, or connected to the modular device). The data may be related to the patient being operated on (e.g., tissue characteristics or insufflation pressure) or the modular device itself (e.g., rate at which the knife is advanced, motor current or energy level). For example, control algorithms for surgical stapling and severing instruments may control the rate at which a motor of the instrument drives its knife through tissue based on the resistance encountered by the knife as it advances.
Those skilled in the art will recognize that, in general, terms used herein, and particularly in the appended claims (e.g., bodies of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to," the term "having" should be construed as "having at least," the term "comprising" should be construed as "including but not limited to," etc.). It will be further understood by those with skill in the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim(s). However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.
In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Moreover, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that, in general, unless the context indicates otherwise, disjunctive words and/or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to encompass the possibility of including one of the terms, either of the terms, or both. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".
For the purposes of the appended claims, those skilled in the art will understand that the operations recited therein can generally be performed in any order. In addition, while a plurality of operational flow diagrams are listed in order(s), it should be understood that the plurality of operations may be performed in other orders than shown, or may be performed concurrently. Examples of such alternative ordering may include overlapping, staggered, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other altered ordering unless the context dictates otherwise. Moreover, unless the context dictates otherwise, terms such as "responsive to," "related to," or other past-type adjectives are generally not intended to exclude such variants.
It should be appreciated that any reference to "one aspect," "an example," or "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example," and "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.
Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification and/or listed in any application data sheet is incorporated herein by reference, as if the incorporated material was not inconsistent herewith. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
In summary, many of the benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the present invention are possible in light of the above teachings. One or more of the forms selected and described are chosen to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various forms and various modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.
Claims (19)
1. A return pad of an electrosurgical system, the return pad comprising:
a plurality of conductive members configured to receive radio frequency alternating current applied to a patient by an instrument of the electrosurgical system; and
A plurality of sensing devices configured to be capable of detecting at least one of:
a nerve control signal applied to the patient; and
Movement of the anatomical feature of the patient caused by application of the nerve control signal, and
Wherein the electrosurgical system comprises a generator, the generator is configured to:
generating a radio frequency alternating current as a high frequency waveform;
generating a low frequency waveform configured to stimulate a nerve of the patient;
modulating the low frequency waveform with the high frequency waveform to form a composite waveform; and
Supplying the composite waveform to the instrument,
Wherein the high frequency waveform is used to heat target tissue of a patient and exit the patient's body and is then received by the plurality of conductive members of the return pad, and wherein the plurality of sensing devices of the return pad are configured to detect monopolar nerve control signals applied to the patient generated by the low frequency waveform and/or movement of anatomical features of the patient caused by application of the nerve control signals.
2. The return pad of claim 1, wherein the plurality of conductive members are further configured for capacitive coupling with the patient.
3. The return pad of claim 1, further comprising a switching device configured to selectively decouple at least one of the plurality of conductive members from another of the plurality of conductive members.
4. The return pad of claim 1, further comprising a switching device configured to selectively decouple each of the conductive members from another conductive member.
5. The return pad of claim 1, further comprising a switching device configured to selectively decouple the plurality of conductive members from the patient.
6. The return pad of claim 1, further comprising a switching device configured to selectively decouple the plurality of conductive members from a generator.
7. The return pad of claim 1, further comprising a switching device configured to selectively couple each of the plurality of conductive members to a generator.
8. The return pad of claim 1, wherein the plurality of sensing devices are configured as an array of sensing devices.
9. The return pad of claim 1, wherein each sensing device of the plurality of sensing devices is coupled to a corresponding one of the plurality of conductive members.
10. The return pad of claim 1, wherein each of the plurality of conductive members is coupled to a corresponding one of the plurality of sensing devices.
11. The return pad of claim 1, wherein at least one of the plurality of sensing devices comprises one of:
a pressure sensor;
an accelerometer; and
Pressure sensors and accelerometers.
12. The return pad of claim 1, wherein each of the plurality of sensing devices is further configured to output a signal indicative of detection.
13. An electrosurgical system, comprising:
A generator configured to be capable of supplying a radio frequency alternating current;
An instrument configured to apply the alternating current to a patient;
the return pad of claim 1, the return pad being capacitively coupleable to the patient; and
A conductor coupled to the return pad and the generator, an
Wherein the generator is further configured to:
generating the alternating current as a high frequency waveform;
generating a low frequency waveform configured to stimulate a nerve of the patient;
modulating the low frequency waveform with the high frequency waveform to form a composite waveform; and
The composite waveform is supplied to the instrument.
14. The electrosurgical system of claim 13, further comprising a multiple-input-single-output switching device coupled to each sensing device of the plurality of sensing devices.
15. The electrosurgical system of claim 14, further comprising an analog-to-digital converter coupled to the multiple-input-to-single-output switching device.
16. The electrosurgical system of claim 13, wherein the generator is further configured to amplitude modulate the low frequency waveform to form the composite waveform.
17. A return pad of an electrosurgical system, the return pad comprising:
a plurality of electrodes configured for capacitive coupling with a patient; and
An array of sensing devices configured to be capable of detecting at least one of:
a nerve control signal applied to the patient; and
Movement of the anatomical feature of the patient caused by application of the nerve control signal, and
Wherein the electrosurgical system comprises a generator, the generator is configured to:
generating a radio frequency alternating current as a high frequency waveform;
generating a low frequency waveform configured to stimulate a nerve of the patient;
modulating the low frequency waveform with the high frequency waveform to form a composite waveform; and
Supplying the composite waveform to an instrument of the electrosurgical system that applies the composite waveform to the patient,
Wherein the high frequency waveform is used to heat target tissue of a patient and exit the patient's body and then are received by the plurality of electrodes of the return pad, and wherein the array of sensing devices of the return pad is configured to detect monopolar nerve control signals applied to the patient generated by the low frequency waveform and/or movement of anatomical features of the patient caused by application of the nerve control signals.
18. The return pad of claim 17, wherein each sensing device in the array of sensing devices is configured to output a signal indicative of detection.
19. The return pad of claim 17, wherein each sensing device in the array of sensing devices is positioned on a corresponding one of the plurality of electrodes.
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JP2021509038A (en) | 2021-03-18 |
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