WO2019198088A1 - Surgical device - Google Patents

Abstract

A surgical device is provided. The surgical device includes a shaft including a drive mechanism having a rotatable elongated member and a sensing mechanism for sensing a number of rotations of the elongated member.

Description

SURGICAL DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/655,884, filed April 11, 2018, entitled“SURGICAL DEVICE”, the contents of which are incorporated herein by reference in their entirety.

BACKGROUND

The present invention relates to a surgical device and, more particularly, to a surgical device that includes a drive mechanism having a rotating shaft and a sensing mechanism for sensing a number of rotations and optionally a rotational position of the shaft.

Devices capable of delivering staples, fasteners (e.g. tacks), anchors and tissue adhesives as well devices for manipulating tissue (e.g. graspers) are commonly used in minimally invasive surgery. Such devices enable rapid and accurate manipulation and ligation of tissue and/or fixation of implants to tissue under the anatomical space constraints imposed by minimally invasive surgery.

While minimally invasive surgery has its benefits, one limitation thereof arises from the anatomical space constraints and the resulting inability of a surgeon to visualize the operating end of the device. Most of the minimally invasive devices in use today are simple mechanical devices prone to mechanical mishaps that can lead to operational failures. In the case of tissue fasteners, failure to identify such mechanical mishaps can lead to incomplete delivery of a tissue fastener and suboptimal ligation of tissue or attachment of an implant.

There is thus a need for, and it would be highly advantageous to have, a sensing mechanism that can be used to verify the operational status of a medical device, such as a tissue fastening device, so as to enable a surgeon to readily identify and correct any operational mishaps. SUMMARY

According to one aspect of the present invention there is provided a surgical device comprising a shaft including a drive mechanism having a rotatable elongated member; and a sensing mechanism for sensing a number of rotations of the elongated member.

According to further features in preferred embodiments of the invention described below, the sensing mechanism also senses a rotation position of the elongated member.

According to still further features in the described preferred embodiments the device further comprises a handle attachable to the shaft, the handle including a motor for actuating the drive mechanism.

According to still further features in the described preferred embodiments the elongated member includes an implant driver disposed in the distal portion of the shaft.

According to still further features in the described preferred embodiments the distal portion of the shaft includes a single or plurality of implants.

According to still further features in the described preferred embodiments the implants are tacks, anchors, screws, mesh or glue.

According to still further features in the described preferred embodiments the elongated member operates a tissue manipulator disposed in the distal portion of the shaft.

According to still further features in the described preferred embodiments the tissue manipulator is a grasper, a glue pump or a mesh deployment.

According to still further features in the described preferred embodiments the handle includes a trigger and further wherein activation of the trigger deploys a single implant from a distal opening of the shaft.

According to still further features in the described preferred embodiments the elongated element rotates more than one time to deploy the single implant from the distal opening of the shaft.

According to still further features in the described preferred embodiments the sensing mechanism includes a plurality of gears for translating rotation of the shaft to a rotation of a dial. According to still further features in the described preferred embodiments the dial includes a diametric magnet.

According to still further features in the described preferred embodiments the handle includes a reader for determining a position of the dial.

According to still further features in the described preferred embodiments the reader is a chip.

According to still further features in the described preferred embodiments each rotation of the elongated member is translated to less than one rotation of the dial.

According to still further features in the described preferred embodiments a plurality of rotations of the elongated member are translated to a single rotation of the dial.

According to still further features in the described preferred embodiments the chip regulates operation of the motor.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings:

FIGs. 1 and 2 are isometric views of one embodiment of the present device showing the shaft attached (Figure 1) and detached (Figure 2) from the handle.

FIG. 3 is an isometric view of the device of Figure 1 with the handle and shaft housings removed.

FIG. 4 is a side view of the device of Figure 1 showing the cartridge portion of the shaft in an angled position.

FIG. 5 is a side cutaway view of the handle of one embodiment of the present device.

FIGs. 6A-B illustrate the drive unit of the handle, the geared mechanism of the shaft and the interface between the shaft and handle of one embodiment of the present device. The interface is shown in a disengaged (Figure 6A) and engaged (Figure 6B) states.

FIGs. 7A-C illustrate delivery of a tissue fastener from the distal end of the shaft of one embodiment of the present device.

DETAILED DESCRIPTION

The present invention is of a surgical device which can be used in minimally invasive surgery. Embodiments of the present invention can be used to provide a surgeon with feedback relating to the operational state of an effector end, such as a tissue grasper or tissue fastener delivery end, of a surgical device used in minimally invasive surgery.

The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Minimally invasive surgical devices are well known in the art. Such devices can be used to manipulate tissue (e.g. graspers), to ligate tissues (e.g., suturing devices, staplers), or to attach implants such as meshes to body tissues (e.g. tacks). Such devices are typically mechanical and are operated manually or via a motor.

In a previously filed application, the present inventors described one such device which includes a motorized drive mechanism for delivering tissue fasteners.

While continuing development of the device and experimenting with various prototypes, the present inventors discovered that there is a need for surgeon feedback as to the operational state of the effector end of the device when positioned within the body.

Such feedback is especially critical when the surgical device is utilized for delivering a tissue fastener since incomplete delivery can result in suboptimal tissue ligation or tissue to implant attachment.

The present sensing mechanism was developed in order to provide a surgeon with feedback regarding the operational state of a minimally invasive surgical tool and maintain the device modular, simple and amenable to single use. Minimally invasive devices that utilize a motorized handle typically include a single use shaft connectable to a multi-use handle. This modular construction allows a surgeon to discard a shaft following a procedure and use multiple shaft types with a single handle. To address these needs, the present sensing mechanism was also developed in order to function with various shaft types and provide operational feedback regardless of the shaft type used with the handle.

Thus, according to one aspect of the present invention there is provided a surgical device which is capable of approximating, cutting, ligating and fixating tissues and/or implants such as meshes and the like and can be used in both open and minimally invasive surgeries. The present device can be used in hernia mesh repair, both Inguinal and Ventral, Laparoscopic and open approaches. It can also be used for repairing pelvic or rectal prolapse.

The surgical device includes a handle and a rigid or articulating shaft. The articulating shaft can include a proximal portion attached to a distal portion through an articulation region. The articulation mechanism can include a hollow tube disposed (coaxially) within the proximal portion of the shaft with a first gear being disposed at the distal end of the tube. The gear teeth of the first gear are arranged around the tube or form an end thereof and are designed to selectively engage perpendicularly oriented teeth of a second gear disposed in the distal portion. The handle can include a roller or slide-type interface that can be actuated to rotate the tube through a set of drive gears. The tube can be rotated in clockwise or counterclockwise directions (by rolling or sliding forwards or backwards) one or more full rotations. The number of rotations required to achieve maximum articulation depends on the gear ratio provided between the first and second gears.

The roller interface can be used to set articulation at any angle between 0-95 degrees (between the proximal and distal portions) e.g. 10, 20, 40, 60, 80, 90 degrees.

The handle can include a drive mechanism including a motor, a battery pack and associated electronics and interface elements for controlling and driving a rotatable elongated member which in turn drives an effector end such as a grasper or a fastener delivery mechanism disposed in the distal portion of the shaft.

The rotatable elongated member runs the length of the shaft from the handle to the distal portion, in the case of an articulating shaft, the rotatable elongated member traverses the articulation region through the first gear.

The interface for the drive mechanism (e.g. trigger) allows a user to actuate grasper jaws, cutters etc. or deliver a single fastener from the distal end of the shaft with a single push of the button. Delivery is actuated by the motor which rotates the elongated member a preselected number of rotations for every push of the button. Rotation of the elongated member rotates the fastener delivery mechanism which in turn rotates and delivers a fastener.

The distal portion of the shaft which includes the fastener delivery mechanism also includes a fastener cartridge holding two or more (preferably 3, 4, 5, 6, 7, 10 or more) fasteners arranged along a length of the distal portion. The fasteners can be coupled to one another such that delivery of one fastener advances all the fasteners in the cartridge and 'cocks' the cartridge for subsequent delivery.

The handle can be permanently attached to the shaft or removably attached thereto. The latter case enables use of several handle types with one shaft and/or reuse of the handle or use of one handle with several shafts.

The surgical device also includes a sensing mechanism for sensing a number of rotations and a rotational position of the rotatable elongated member.

Such a sensing mechanism includes a sensor for sensing rotation of the rotatable elongated member and a reader for translating a signal from the sensor into information relating to the number of rotations and rotational position of the shaft. The sensor can be positioned in the shaft while the reader can be positioned in the handle. The information generated by the reader can be provided to the user through, for example, a digital display forming a part of the handle or being in communication with the device.

Several types of sensing mechanisms can be used with the present invention. Such sensing mechanisms can employ optical or magnetic/mechanical sensors. For example, an optical sensor can rely on reflection or interruption. A reflective sensor operates by shining a beam of light against the target and then measuring the resultant reflected beam. This method yields a great deal of flexibility and can be used not only to measure the speed of passing features as they change the amount of light reflected, but with an appropriate sensor can also measure the actual distance to the target.

An interrupter (optical) sensor works by having the target interrupt a beam of light shining from an emitter to a receiver. Because the target needs to move through the sensing structure, this sensor offers less flexibility than a reflective sensor. The major advantage of an optical interrupter is cost; it is readily available for less than $1 from numerous manufacturers.

Magnetic sensors can employ variable -reluctance (VR), eddy-current killed oscillator (ECKO), Wiegand sensors, and Hall-effect sensors.

A Variable-Reluctance sensor is a transducer that, when combined with very basic electronic circuitry, detects the change in presence or proximity of ferrous objects. The ECKO approach is unusual in that it can detect nonferrous metal targets such as brass, stainless steel, and aluminum. The Wiegand sensor is structurally similar to a VR sensor, with a coil around a core. The difference is that the Wiegand sensor doesn't use a magnet as a core and needs to be actuated with an external magnet attached to the target. A Hall effect sensor is a transducer that varies its output voltage in response to a magnetic field.

One type of sensing mechanism that is particularly advantageous for its simplicity and modularity includes a gear mechanism for translating rotations and rotational position of the shaft to a magnetic field strength signal which is then relayed to a chip for translating this signal to actual rotational information.

Such a sensing mechanism is described hereinbelow with reference to a tissue fastener delivery device. Referring now to the drawings, Figures 1-7 illustrate a tissue fastener delivery device that is referred to herein as device 10.

Device 10 is configured for delivering an implant such as a tack- type tissue fastener (e.g. corkscrew) suitable for attaching a surgical mesh such as a hernia mesh to tissue. Alternative embodiments of the present device can be used to deliver a suture, staples or manipulate tissue via a grasper or cutter (scissor) -type effector end.

Device 10 includes a handle 12 and a shaft 14. Shaft 14 can be rigid or articulating. In the embodiment shown in Figures 1-4, shaft 14 includes a proximal portion 16 attached to a distal portion 18 through an articulation region 20. Figure 4 illustrates distal portion 18 angled (at approximately 80 degrees) with respect to proximal portion 16.

Handle 12 can be permanently attached to shaft 14 (e.g. glued) or it can be attached thereto through a releasable interface between the drive unit positioned in the handle and the elongated member (also referred to herein as driveshaft) positioned in the shaft as well as between housing 13 of handle 12 and proximal housing 15 of shaft 14. At its distal end, a driveshaft 50 (Figures 3, 6A-B) is connected to a tack delivery mechanism positioned within a tack cartridge.

Handle 12 can be fabricated from a polymer such as Polycarbonate, ABS, Polyurethane using Injection molding, casting machining or 3D printing approaches. Preferably two halves forming the handle shell are fabricated using injection molding and the two halves are glued or mechanically adjoined around the internal components (further described hereinunder). Typical dimensions for handle 12 are 145-200 mm length, 35-55 mm height and 25-50 mm width.

Handle 12 is ergonomically shaped and is operated by wrapping two to four fingers around the handle body with the thumb over the articulation control (slider) 21 of user interface and forefinger at the fastener actuation button (trigger) 23 (shown in Figure 4) of the interface. As is shown in Figure 2, slider 21 forms a part of shaft 14 (and is positioned within handle 12 when shaft 12 is coupled thereto), while trigger 23 forms a part of handle 12 (Figure 4).

Handle 12 can also include a neutral activation button for engaging/disengaging the articulation gear. When neutral activation button is disengaged, the distal portion of the shaft can articulate freely (simply by pushing the handle against the shaft) and the fastener delivery button is deactivated to prevent delivery of a fastener while the distal portion is articulated. Once an articulation angle is selected by the operator, engaging the neutral activation button locks articulation and allows delivery of a fastener from the distal end (as is indicated by a pair of LED lights on the handle).

Handle 12 further includes a port (e.g. USB) for programming a microcontroller of the fastener delivery mechanism in handle 12. The port can be positioned at the proximal end of handle 12 or on a side face of handle 12.

Shaft 14 can be fabricated from a variety of medical grade stainless steel using machining approaches. Typical dimensions for shaft 14 are 200-300 mm length and 5- 10 mm outer diameter. A lumen extends the length of shaft 12 and is 3-6 mm in diameter. A driveshaft 50 positioned within the lumen can be fabricated from a polymer or a metal, driveshaft 50 extends out from a proximal end of shaft 14 to a cartridge (distal) portion thereof.

Proximal portion 16 of shaft 14 and proximal portion 17 of driveshaft 50 are connectable to handle 12 via a handle coupling mechanism 24 (coupling housings of shaft and handle and driveshaft 50 to motor 23). Proximal portion 16 is typically 200- 300 mm in length. Distal portion 18 is connected to proximal portion 16 distally to an articulation region 20. Distal portion 18 includes tissue fastener cartridge 26 and mechanism for delivering one or more tissue fasteners through distal opening 28. Distal portion 18 is typically 50-70 mm in length.

Handle 12 controls both articulation of distal portion 18 and delivery of tissue fasteners from cartridge 26.

Figure 2 illustrates handle 12 detached from shaft 14 showing housing 13 of handle 12 and proximal housing 15 of shaft 14. Distal end 30 of handle 12 (Figures 3 and 5) includes a coupling mechanism 32 for interfacing with a respective coupling mechanism 34 of shaft 14 (also shown in Figures 6A-B) as well as internal shaft components for transferring actions from articulation control 21 to articulation region 20 and from trigger 23 to cartridge 20.

Figure 3 illustrates handle 12 and shaft 14 with housing 13 and proximal housing 15 removed.

Coupling mechanisms 32 and 34 include couplers that engage when shaft 14 is connected to handle 12 (Figure 6B). Figures 3 and 5 illustrates the internal components of handle 12, showing motor 42 (e.g., a stepper motor which rotates a predefined distance upon triggering of trigger 23), battery 44 and associated handle fastener mechanism 46 and trigger 23 for actuating rotation of rotatable elongated member (driveshaft) 50 for delivering a tack from distal end of shaft 14.

Driveshaft 50 is a hollow, preferably metal alloy (e.g. stainless steel or titanium) tube having a length of 35-40 mm an outer diameter (OD) of 3.0-4.0 and an inner diameter (ID) of 2.2-2.5 mm.

Detailed description of articulation, tack delivery mechanism and tack cartridge can be found in WO2016157171 which is fully incorporated herein by reference.

Several types of fasteners can be used along with device 10 of the present inventions. Such fasteners can be fabricated from a metal alloy (e.g. titanium, stainless steel) or a polymer (e.g. nylon). The fastener can also be fabricated from poly -lactic and/or -glycolic acid to enable biodegradation. The fasteners include a tissue piercing end (surgical needle type bevel) at a distal end of a fastener body that can be shaped as a corkscrew/spiral from round or square wire forming a base measuring about 3.6 mm² and a coil measuring 4.0 to 6.0 mm in length. The spiral can have a pitch of 1.2 to 1.8 mm.

As is mentioned hereinabove, device 10 of the present invention includes a sensing mechanism for sensing a number of rotations and optionally a rotation position of the elongated member and translating such rotations and optionally position to a delivery state of a tissue fastener (or in other embodiments of the present device to an actuation state of a tissue effector end).

Figures 6A-B illustrate one embodiment of such a sensing mechanism that is referred to herein as sensing mechanism 60. Figure 6A shows shaft 14 disengaged from handle 12 while Figure 6B shows shaft 14 engaged to handle 12.

Sensing mechanism 60 includes two portions, a first portion 62 positioned in shaft 14 and a second portion 64 positioned in handle 12. First portion 62 includes a first gear 66 attached to driveshaft 50, a second dual gear 68 and a third gear 70. Second dual gear 68 is interposed between first gear 66 and third gear 70 and transfers rotation of first gear 66 (and driveshaft 50) to rotation of third gear 70. Gears 66-70 can be fabricated from a polymer such as nylon or from a metal such as aluminum or stainless steel. Gear 66 is dedicated to shaft 12 and the type of actuation (implant delivery, tissue manipulation) effected by driveshaft 50. This enables device 10 to accept a variety of shaft types with each shaft and shaft-included mechanism having a dedicated gear 66 (shape, number of teeth, diameter). Gear 66 is matched with the number of rotations of driveshaft 50 required to complete an operation of device 10.

First gear 66 is mounted around drive shaft 50 and is 2.0-10.0 mm in diameter and includes 10-20 teeth. Second dual gear 68 includes a distal-facing gear 72 that is 2.0-10.0 mm in diameter and includes 10-20 teeth. The teeth of distal-facing gear 72 engage teeth of first gear 66. Second dual gear 68 also includes a proximal-facing gear 74 that is 2.0-10.0 mm in diameter, includes 10-20 teeth and is tapered (conical) in shape. The teeth of proximal-facing gear 74 perpendicularly engage teeth of third gear 70 that is 5.0-15.0 mm in diameter and includes 15-45 teeth. Third gear 70 includes a diametric magnet like Radial Magnet Inc. pari number 9042 that produces a magnetic field readable by a sensor 80 when positioned in proximity to third gear 70 (when shaft 14 is coupled to handle 12, Figure 6B). Sensor 80 is a magnetic field sensor (e.g. AMS AS5048A-HTSP-500CT-ND) designed for sensing magnetic field strength When the third gear is rotated the magnetic polarity is changed varies with the device. The magnetic sensor on sensor 80 senses changes in the magnetic field and translates it to electronic signals. The processor translates these electronic signals to spatial rotation changes.

Gears 66-70 of first portion 62 are configured such that a single rotation of driveshaft 50 is translated to less than a single rotation of third gear 70. For example, gears 66-70 can be configured such that a single rotation of driveshaft 50 is translated to a third or a quarter rotation of third gear 70. In other words, each full rotation of third gear 70 can equal 2, 3, 4, 5, 6, 7 or 8 or more full rotations of driveshaft 50. In cases where several rotations of driveshaft 50 are required to complete actuation (delivery of a tack, or complete closure of grasper jaws), such gear-mediated translation enables sensing mechanism 60 to track the number of rotations of driveshaft 50 and to determine the position of driveshaft 50 throughout such rotations.

For example, in a device 10 configured for tack delivery and requiring 4 rotations of driveshaft 50 to complete delivery of a single tack 100 (Figures 7A-C), gears 66-70 can be configured as follows. The ratio between gears 66 and 72 is 12:16 (3:4) and between gears 74 and 70 is 12:36 (1:3) for a final ratio is 1:4. In order to provide feedback to a user (e.g. surgeon) of device 10, sensing mechanism also includes second portion 64 positioned in handle 12. Second portion 64 includes a reader 82 (Figures 6A-B) for translating the magnetic field strength sensed by sensor 80 to a rotation count and a rotational position of driveshaft 50. Reader 82 includes a processor (a microcontroller such as STMicroelectronics STM32F301K8U6) that translates the electronic signals to rotational movement count and position.

Reader 82 can communicate the operational state of device 10 to a user through a display positioned on handle 12 (or in communication with device 10), LED lights on the handle (green/red). Pre-defined states can be indicated by lights. For example, ready to use - flashing Green, Standby (ready to fire) - constant Green and not ready to use / Error - Constant Red.

Device 10 includes several safeguards against failed actuation (e.g. incomplete tack delivery). For example, sensing mechanism 60 can be operationally coupled to the delivery mechanism to prevent re-actuation of implant (tissue fastener) delivery in cases where a previous delivery attempt was not completed or motor 42 can be auto- actuated to remount (within cartridge) or expel (from cartridge) a mis -delivered tack. A mis-delivered tack can occur when tack tissue insertion is incomplete (high external load for example). In such a case it is possible that full rotations of the driveshaft were not completed, hence the next tack is not in a“standby” position. Under such conditions, the magnetic sensor will assess the actual magnet position and the microcontroller will correct“next tack” position to achieve best results.

As is mentioned hereinabove, device 10 of the present invention can be used in a variety of fully open or minimally invasive medical procedures.

One preferred use for device 10 is tacking of a mesh in minimally invasive repair of an inguinal hernia.

Following insertion of a mesh via a working port and positioning of the mesh against the abdominal wall the device of the present invention is turned on and the shaft of choice (with attached cartridge) is selected and attached to the handle. After verifying the shaft is straight, it is then inserted into the abdominal cavity via a standard access port with the appropriate size opening. The mesh is deployed via a dedicated port and held in position via a grasper, the shaft is then articulated such that the cartridge distal end is pressed perpendicularly against the mesh and the abdominal wall. The tack firing button is then actuated, and a single tack is deployed into the mesh and tissue. If tack delivery is successful (as assessed by sensing mechanism 60), the trigger is then released, and the cartridge is repositioned at the next tacking location to deliver the next tack. This process is repeated until the mesh is satisfactorily attached, the shaft is then straightened and removed from the body.

As used herein the term“about” refers to ± 10 %.

Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting.

EXAMPLES

Reference is now made to the following example, which together with the above descriptions, illustrate the invention in a non limiting fashion.

Prototypes constructed in accordance with the teachings of the present invention were bench tested using a tissue phantom, a hernia mesh and a test fixture and were forced into“failure mode” in order to test device feedback.

The tissue phantom simulated the bio -mechanical characteristics of an abdominal facia and the Cupper Ligament (where the tacks are inserted). To ensure that the prototype device meets requirements, several commercial meshes were used in combination with the tissue phantom (SOFT MESH, VENTRALEX, VENTRIO, VENTRALIGHT and SEPRAMESH).

The test fixture forced the device into under-shoot (incomplete insertion of tack) or over-shoot (tack inserted too deep) modes. Both cases were identified by the device sensor and a corresponding alert light (red LED light) was presented to the user. The device was also tested by calibrating the sensor to allow small under-shoots and over-shoots in which case no alert was provided to the user.

The prototypes delivered the desired performance and correct indications during operation and when forced into a“failure mode”. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

WHAT IS CLAIMED IS:

1. A surgical device comprising:

(a) a shaft including a drive mechanism having a rotatable elongated member; and

(b) a sensing mechanism for sensing a number of rotations of said elongated member.

2. The device of claim 1, wherein said sensing mechanism also senses a rotation position of said elongated member.

3. The device of any one of claims 1 and 2, further comprising a handle attachable to said shaft, said handle including a motor for actuating said drive mechanism.

4. The device of any one of claims 1-3, wherein said elongated member includes an implant driver disposed at a distal portion of said shaft.

5. The device of claim 4, wherein said distal portion of said shaft includes a single or plurality of implants.

6. The device of claim 5, wherein said implants are tacks, anchors, screws, mesh or glue.

7. The device of any one of claims 4-6, wherein said elongated member operates a tissue manipulator disposed in said distal portion of said shaft.

8. The device of claim 7, wherein said tissue manipulator is a grasper, a glue pump or a mesh deployment.

9. The device of claim 5, wherein said handle include a trigger and further wherein activation of said trigger deploys a single implant from a distal opening of said shaft.

10. The device of claim 9, wherein said elongated element rotates more than one time to deploy said single implant from said distal opening of said shaft.

11. The device of any one of claims 1-10, wherein said sensing mechanism includes a plurality of gears for translating rotation of said shaft to a rotation of a dial.

12. The device of claim 11, wherein said dial includes a diametric magnet.

13. The device of any one of claims 11-12, wherein said handle includes a reader for determining a position of said dial.

14. The device of claim 13, wherein said reader is a chip.

15. The device of any one of claims 11-14, wherein each rotation of said elongated member is translated to less than one rotation of said dial.

16. The device of any one of claims 11-15, wherein a plurality of rotations of said elongated member are translated to a single rotation of said dial.

17. The device of any one of claims 14-16, wherein said chip regulates operation of said motor.