AU2003258764A1

AU2003258764A1 - System for treating obesity and implant therefor

Info

Publication number: AU2003258764A1
Application number: AU2003258764A
Authority: AU
Inventors: Richard Cancel; Daniel Grepillat; Gerard Sassi; Richard Wallace
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-06-13
Filing date: 2003-05-16
Publication date: 2003-12-31
Also published as: IS7591A; BR0311606A; EP1519698B1; EP1519698A1; WO2003105732A1; JP2005528969A; RU2004136572A; NO20045265L; IL165575A0; FR2840804A1; FR2840804B1; WO2003105732A8; CA2488640A1; JP4471835B2

Description

For: SYSTEM FOR THE TREATMENT OF OBESITY AND IMPLANT FOR A SYSTEM OF THIS TYPE VERIFICATION OF TRANSLATION Arthur C. Haines, residing at 614 South 8 Street, Philadelphia, PA 19147, declares: (1) that he knows well both the French and English languages; (2) that he translated the above-identified Application from French to English; (3) that the attached English translation is a true and correct translation of the above identified Application to the best of his knowledge and belief; and (4) that all statements made of his own knowledge are true and that all statements made of information and belief are believed to be true, and further that these statements are made with the knowledge that willful false statements and the ilke may jeopardize the validity of the Application or any patent issuing thereon. Date: ou . . e% Locs ae rurC. aines -PHIL 1:36170 7 6.v ..... ,v~a ,J.r"t, iIUJ/I UOr SYSTEM FOR THE TREATMENT OF OBESITY AND IMPLANT FOR A SYSTEM OF THIS TYPE The present invention pertains to a system for the treatment of obesity, constituted by a motorized gastric implant and a control equipment unit intended for a medical operator. Such equipment units are known in the state of the art in their general principles. PCT patent application WO 01/12108 describes a gastric implant controlled by a power transmission means providing a wireless transmission of power in a first form from the exterior of the body of a patient. An implanted medical device can operate in response to power in a second form different from the power of the first form. An implanted power transmission means transforms the power of the first form, transmitted in a wireless manner by the power transmission means, into power of the second form intended to be used in the control and operating of the medical device. PCT patent application WO 00/15158 describes another constriction gastric implant, at least partially implantable in the human or animal body, comprising a constriction organ forming a ring in its operating configuration. This constriction organ comprises a flexible band, both ends of which are adjacent to each other in the operating configuration, as well as a means for actuating the constriction organ. One end of the flexible band comprises a tractable element enabling the displacement of said end in relation to the other end generating a radial deformation of the constriction organ. Patent application WO 01/112076 Al describes a device for the treatment of gastric burning sensations and gastroesophogeal reflux which comprises a controllable constriction device that can be implanted in a patient or animal, said device being intended to come into contact with the stomach close to the cardia or to come into contact with the esophagus in a manner such as to form VU I /hHUJ/U1505 2 a constriction in the alimentary canal. A power emission organ enabling a wireless emission of power of a first form originating from the exterior of the patient is provided. This constriction device can be made to operate by reaction of power of a second form different from the power of the first form, delivered in a manner so as to vary the constriction in the alimentary canal. An implantable power transformation organ is used for transforming the power of the first form emitted by the power emission organ into power of the second form. The implementation of such implants creates difficulties linked to the electromagnetic power necessary for the good operation of the implant. It is in fact important that the induction power be sufficient to ensure good operation of the motor but, if the power is excessive, it can cause heating which can become harmful. This difficulty is increased by the fact that the positioning of the implant varies from one patient to another, and that the relative orientation as well as the distance between the antennas of the implant and the control equipment unit has a major impact on the transmitted power. One solution consists of separating the induction coil from the implant so as to allow positioning of the coil close to the patient's skin. Although this certainly reduces the power transmission problems, it involves a more intensive surgical intervention. One goal of the present invention is to avoid such a surgical intervention and to make it unnecessary for the patient to have an antenna under his skin, said antenna being furthermore required to be physically linked to the implant. Another goal of the invention is to resolve the problem of the adequacy of the transmitted power and to increase the safety of use of the gastric rings. For this purpose, the invention pertains, in its most general sense, to a system for the treatment of obesity comprising a gastric implant for the control of alimentary absorption and a control equipment unit, the gastric 3 implant comprising a ring designed to fit around the esophagus and a motorized control means for the adjustment of the extension of said ring, as well as an induction coil for the wireless powering of the motorized control means, characterized in that the induction coil of the implant is integrated in the implant and in that the control equipment unit comprises means for the adjustment of the emission power and in that the implant comprises an electronic circuit delivering a response signal to a command transmitted by the control equipment unit. The implant advantageously comprises: - a memory for recording digital identification data of the implant [date of manufacture, series number, etc.]; - and/or a memory for recording digital identification data of the patient [date of implantation, identifier, etc.]; - and/or a memory for recording digital data corresponding to historical events [date of modification, position]; - and/or a memory for recording the absolute position of the implant; - and/or a memory for recording displacement limits of the ring and a means for preventing command of the motor in the case of receiving commands which would lead to going beyond said limits. According to one preferred variant, the control equipment unit comprises means for receiving information recorded in the memory of an implant and a memory for recording, e.g., historical data, comprising the identifier of each of the controlled implants and the date of modification of each of said implants. The control equipment unit advantageously comprises a mobile antenna and a means for generation of a digital reference screen for the step of adjustment of the emission power prior to the step of commanding an implanted ring.

TV %a..V IJ/ 1 ' ut, l ii"mUU i o i 4 The control equipment unit preferably comprises a circuit for modulation of the amplitude of the feed voltage of the mobile antenna. According to one particular variant, the implant comprises a time delay activating the vigilance mode after a predetermined period without command signals. According to another variant, the system comprises a test function commanding the displacement of the implant, i.e., the closing then the opening of a position. The control equipment unit preferably comprises a calculator for the creation of a command signal which is a function of a position input by an operator and the control information stemming from the implant to be commanded. According to one preferred mode of implementation, the control equipment unit is capable of generating a secure signal for the displacement of one step of the implant motor. Better comprehension of the invention will be obtained from the description below with reference to the attached drawings pertaining to a nonlirnitative example of implantation in which: - figure 1 shows a sectional view of an implant according to the invention; - figure 2 shows a block diagram of the control equipment unit; - figure 3 shows a block diagram of the electronic circuits of the implant; - figure 4 shows the operating algorithm of the control equipment unit; - figure 5 shows the operating algorithm of the implant; - figure 6 shows a block diagram of a variant of implementation of the control equipment unit (command console - transmitter/receiver). The implant shown in figure 1 in section view comprises a case (1) of a section of circa 10 mm up to 20 mm so as to allow housing of the antenna in the case and to enable implantation by laparoscopy. This case closed by a cap (4) incorporates an electronic circuit (8) a brushless motor (2) driving a in ii r ri u31 u i DUD 5 threaded coupling (3) capable of translational displacement in a tubular lip (5). This threaded coupling (3) extends one of the ends of a band (6) forming the gastric ring (10). This ring presents a deployed length of 85 millimeters. The maximal perimeter is preferably 85 millimeters. The opposite end of the threaded coupling (3) presents a hook for attachment to the body of the case (1) after implantation around the esophagus. The implant furthermore comprises an induction coil constituted by a support of rectangular form presenting conductive windings. The course of the threaded coupling (3) is approximately 15 to 25 millimeters. The length of the case is approximately 70 to 85 millimeters. The length of the induction coil is approximately 67 to 82 millimeters. The displacement rate is approximately 12 to 25 mm per minute with a force of 8 to 12 newton. The course is divided into 8 positions distributed linearly with a precision of approximately 10%. According to a first mode of implementation of the invention, the motor comprises an encoder formed, e.g., by a Hall sensor detecting angular displacement and transmitting a relative displacement signal to the electronic circuit of the implant. According to a second mode of implementation of the invention, the control electronics reconstitute the angular position of the motor then, by counting, the position of the threaded coupling. The electronic circuit integrated in the implant comprises a nonvolatile random access memory for recording before implantation information not modifiable after the locking of each of them, such as: - the series number of the implant; - the patient's identifier; - the date of manufacture; - the date when initially put into service; as well as information that can be modified after implantation: - the date of the last intervention; t,% I /rM NVJ/ U1 1utO 6 - historical information on the last N interventions, e.g., the last 8 interventions; - the number of interventions since first being put into service. The implant is positioned such that the ring surrounds the esophagus and not the stomach. Its operation is controlled by a control equipment unit comprising a command console and a mobile antenna that can be positioned close to or preferably on the patient's abdomen with a slight possibility of angular orientation. The block diagram of the control equipment unit is shown in figure 2. It comprises a cut-off power supply (11, 12) with a cut-off voltage reducer circuit (12). The antenna (13) is coupled to a full bridge inverter (14) by a tuned circuit (15). The power transmitted to the antenna (13) is modulated or regulated in amplitude by a step-down device (12) controlled by a microcontroller (16). According to a first mode of implementation, the microcontroller (16) dialogues with an input/output interface (18) controlling a display panel and/or providing the link with a microcomputer. According to a second mode of implementation, the microcontroller (16) dialogues with a microcomputer which is in the console. The equipment unit furthermore comprises a circuit (17) for the detection and processing of the signal stemming from the implant. A time-delay circuit interrupts the powering of the antenna after a predetermined cumulative duration of emission so as to avoid excessive heating. The block diagram of the electronic circuit of the implant is shown in figure 3. It comprises an induction coil (20) linked by a rectifier to a communication circuit (22).

vv wfI VJ I 1t; I /irx uj/u I UbII 7 According to a first mode of implementation of the invention, a power supply (24) in the form of a buffer battery or a condenser or any equivalent means powers the electronic circuits by the intermediary of a regulation circuit (23). According to a second mode of implementation, the coil (20) powers the electronic circuits. A microcontroller (25) controls the brushless motor (26) as well as the memories integrated in the microcontroller (25). The electronic circuit of the implant controls the following functions: - Generation of a specific screen or localization screen for the localization of the control equipment unit during the positioning of the antenna; - Management of the memories, and notably of the locking of information recorded prior to implantation by modification of the state of a flag preventing new writing in the corresponding registers; - Transmitting of data consisting of the generation of messages under the action of a command transmitted by the control equipment unit; - Displacement of the threaded coupling as a function of the instruction emitted by the control equipment unit. Displacement is controlled without sensors, with verification of the displacement by the implant at each position before any new displacement command; - Repositioning of the ring: this function is activated by the control equipment unit under the operator's control when there is incertitude about the effective position of the motor in relation to the recorded information. The control equipment unit sends a message commanding the displacement at the implant motor's stop, in maximal and minimal extension, so as to return to zero the position information and calculate the limited positions. The implant circuit furthermore also generates alarm signals in the case of malfunction: - Detection of blockage: this signal is generated when a displacement command signal is detected and the motor remains inactive; this blockage is vvi%., uoj vurj . JP I iIM U /iUlU 8 detected according to a first mode of implementation because no modification of the signal is provided by the angular position detector of the motor and according to a second mode of implementation in the absence of sensor as a function of the fact that the motor does not start up or slows down to a major degree. The error signal is recorded in a memory of the implant. In the first mode of implementation, the system generates a return command. In the second mode of implementation, the implant returns to its previous position. The control equipment unit presents multiple possible states: - Stop: the electric power is interrupted and the electronic circuits are at rest. The antenna does not emit any radiation; - Waiting: the power is activated and the circuits are powered, the antenna does not emit any radiation; - Normal use: the antenna is powered, the implant is identified; - Use/localization: the antenna is powered and the equipment unit is in phase of adjustment of the emission power by periodic incrementing of the power and measurement of the implant's response, with repositioning of the antenna in order to optimize the transmitted power; - Use/command: the power is set and the equipment unit transmits the command information to the implant; - Use/alarm: the implant or the equipment unit generates an alarm signal. A timer activates the waiting mode after a use of a duration greater than a predetermined value. Similarly, the implant presents different operating states: - Waiting: the default state. The electronic circuits and the motor are not powered; - Localization: the implant detects an emission and dialogues with the equipment unit for the purpose of optimizing the emission power. The goal is to set the emission power at a minimum level required for transmitting sufficient power for the operating of the electronic circuits then the brushless .... ' .PCT/FRO3/01505 9 motor, with an unequivocal detection of the command signals modulating the amplitude of the voltage applied to the antenna of the control equipment unit; - Ready: the implant is ready to receive command signals; - Alarm: the implant generates an alarm signal in response to an operating anomalyv; - Vigilance: the implant does not respond subsequent to an excessively long period of inactivity of the control equipment unit. The description below pertains to an advantageous mode of operating a system according to the invention and specifies several important functional i ties. The control equipment unit first of all emits a command signal for identification of the medical operator. For this purpose, it comprises a procedure for inputting a password and verification, e.g., by means of a cryptologic algorithm. The verification of this procedure opens a session which ends after a determined period of inactivity. The management of the passwords and the users, and especially of new users, is performed by means of a procedure protected by an access master. The creation of a new patient is performed from the opening of a session of a user referenced at a higher level. The control equipment unit comprises a keyboard for inputting the specific information regarding a new patient such as an identifier and for the recording of this information in the memory of a new implant. These data are locked upon the first activation of the implant's motor. The control unit comprises for this purpose an algorithm neutralizing the access in writing of the memory zone intended to receive the information pertaining to the identity of the patient in response to a signal, e.g., after the first request for displacement of the motor. Prior to implantation, the system allows verification of good operating order. For this purpose, the control equipment unit transmits instructions to .L 1 ,, I U,.(Vi I U 10 confirm the rotation of the motor first in one direction and then in the other direction in a single step. The command of an implant comprises a step of positioning the antenna by the practitioner. He displaces the antenna in relation to the patient's body until obtaining, for a given power, the best response signal. The power is then diminished incrementally until reaching the minimum power compatible with a satisfactory powering of the implant. After displaying the data stored in memory in the implant, the practitioner can then command the displacement of the motor, either by calculation of a target displacement or by a step-by-step modification of the positioning of the motor. In the first case, the control equipment unit inputs the actual position of the implant by reading the implant's position memory then calculating the number of positions required for the target position. The equipment unit then modulates the command signal to the implant so as to command the displacement of the implant's motor according to a secure protocol. Another mode of use consists of sending a command signal to provide for the displacement of one step in one direction or in the other direction. Each displacement is performed on a step-by-step basis in order to ensure the correct performance of the displacements. This mode makes it possible to increase or reduce the section of the gastric ring. Each displacement performed by the implant is recorded in the implant's memory so as to save the history of the modification. Only the last modification is time stamped. The system moreover comprises an urgent opening procedure allowing commanding of the maximal opening of the ring without passing through a prior identification step.

* j~j tJCri.. 1 1rr1Luaiu I Duo0 11 The operating of the implant comprises different procedures. The initialization procedure consists of generating a specific screen that can be detected by the control equipment unit during the phase of adjustment of the power applied to the antenna. This procedure is triggered by the detection by the implant of a modulated signal specific to the control equipment unit, so as notably to limit the risk of interaction with other induction devices. It is interrupted, e.g., upon emission of a confirmation signal by the control unit. The invention was described above with reference to a preferred example of implementation. Examples of operating algorithms of the control equipment unit and the implant are shown respectively in figures 4 and 5. Figure 6 shows a block diagram of a variant of implementation of the control equipment unit (command console - transmitter/receiver). The command console of this variant of implementation is constituted by a control card and an industrial computer (100) with a touch screen. The touch screen enables creation of contextual menus by a software application loaded in the random access memory of the computer. This application program activates the tactile zones corresponding solely to the authorized functions, taking into account the state of the system, and prevents all other actions. This solution makes it possible to increase the security of use of the system. Certain security functions such as the management of the passwords are provided not by the computer (100) but by the microcontroller (101) of the control card of the gastric ring. The computer provides the man-machine interface functions while the implant command functions are provided by the electronic circuits of the control card. A peripheral device, e.g., a diskette reader makes it possible to store and/or process the data in memory.

". .... P i/I-HUJ3/U15U5 12 In addition to the microcontroller (101), this control card comprises a power supply (102) comprising a sector transformer (103), a quartz oscillator (104) delivering a clock signal and a circuit (105) for the detection and processing of the signals exchanged with the implant. The power supply and communication with the implant is provided by an antenna (106) powered by a full bridge inverter (107). According to this variant, the feed voltage of the antenna (106) is reduced by a cut-off voltage converter (108). This makes it possible to limit the emission power to that strictly required for the correct operation of the implant. The antenna of the implant is formed by a plastic frame around which is coiled a winding, e.g., spires of enameled copper wire. The frame is integrated in the implant which enhances the reliability of the construction of the implant. According to a first mode of implementation, one uses a thin antenna at the exterior of the case which antenna must be inserted in the patient's body in coiled up form. According to a second mode of implementation, the antenna is placed in the case: this eliminates the risk of failure due to rupture of the thin antenna after insertion. The communication frequency is set at 115.2 kHz to 120.6 kHz so as to enable an optimal transmission of power at a distance of less than 10 centimeters.

Claims

1. System for the treatment of obesity comprising a gastric implant for the control of alimentary absorption and a control equipment unit, the gastric implant comprising a ring designed to fit around the esophagus and a motorized control means for the adjustment of the extension of said ring, as well as an induction coil for the wireless powering of the motorized control means, characterized in that the induction coil of the implant is integrated in the implant and in that the control equipment unit comprises means for the adjustment of the emission power and in that the implant comprises an electronic circuit delivering a response signal to a command transmitted by the control equipment unit.

2. System according to claim 1, characterized in that the electronic circuit of the implant comprises a memory for recording digital identification data of the implant [date of manufacture, series number, etc.].

3. System according to claim 1, characterized in that the electronic circuit of the implant comprises a memory for recording digital identification data of the patient [date of implantation, identification number, name, etc.].

4. System according to claim 1, characterized in that the electronic circuit of the implant comprises a memory for recording digital data corresponding to historical information [date of modification, position; identifier of the control equipment unit, etc.].

5. System according to any one of the preceding claims, characterized in that the implant comprises a memory for recording the absolute position of the ring. ..... ' ..... IPL F I-KUS/i15U5 14

6. System according to any one of the preceding claims, characterized in that the implant comprises a memory for recording displacement limits of the ring, and a means for preventing command of the motor in the case of receiving commands that would lead to going beyond said limits.

7. System according to any one of the preceding claims, characterized in that the control equipment unit comprises means for receiving information recorded in the memory of an implant and a memory for recording the historical information, comprising the identifier of each controlled implant and the date of modification of each of said implants.

8. System according to any one of the preceding claims, characterized in that the control equipment unit comprises a mobile antenna and a means for generation of a digital reference screen for the step of adjustment of the emission power prior to the command step of an implanted antenna.

9. System according to any one of the preceding claims, characterized in that the control equipment unit comprises a circuit for the regulation of the amplitude of the feed voltage of the mobile antenna.

10. System according to any one of the preceding claims, characterized in that the implant comprises a time-delay circuit activating the vigilance mode after a predetermined period without command signals.

11. System according to any one of the preceding claims, characterized in that it comprises a test function commanding the closing of a position then the opening of a position of the implant, the control equipment unit comprising test function deactivation information.

12. System according to any one of the preceding claims, characterized in that the control equipment unit comprises a calculator for the creation of a vvyW Va/ iVoro Pc I iI-IMUJ/U1 bub 15 command signal which is a function of a position input by the operator and the command information stemming from the implant to be controlled.

13. System according to any one of the preceding claims, characterized in that the control equipment unit is capable of generating a secure signal for the displacement of one step of the implant motor.

14. System according to any one of the preceding claims, characterized in that the induction coil of the implant is constituted by a frame comprising a winding, said frame being integrated in the interior of the implant.

15. System according to any one of the preceding claims, characterized in that the command circuit comprises a cut-off voltage converter inserted between the power supply and the full bridge inverter making it possible to limit the emission power.

16. Gastric implant for a system according to at least one of the preceding claims, characterized in that it comprises a ring designed to fit around the esophagus and a motorized control means for the adjustment of said ring, as well as an induction coil for the contactless powering of the motorized control means integrated in the implant and in that it comprises an electronic circuit delivering a response signal to a command transmitted by the control equipment unit.

17. Gastric implant according to claim 16, characterized in that the power supply is implemented by a winding around a frame, said frame being integrated in the implant.