System for communicating with an implantable antenna

TECHNICAL FIELD [0001] The present invention relates to devices for aligning an antenna implanted under the skin with an external device or device placed internally.

BACKGROUND OF THE INVENTION [0002] Obesity is becoming an increasing problem, particularly in the United States, as the number of obese people is constantly increasing and more and more is known about the negative effects of obesity on health. Morbid obesity, where the weight of a person is greater by 100 pounds (45.36 kg) or more compared to ideal body weight, is in particular a significant risk of serious health problems. Therefore, much attention is paid to the treatment of obese patients. One method of treating morbid obesity was to place a limiting device, such as an oblong band, around the upper stomach. The gastric bands usually contained a fluid-filled elastomeric balloon with fixed points of ending, which surrounds the stomach directly below the junction of the stomach and esophagus to shape the small stomach pouch above the band and reduce the mouth of the mouth in the stomach. When the liquid is introduced into the balloon, the band expands on the stomach, creating a restriction of food intake or mouth in the stomach. In order to reduce this limitation, the liquid from the band is removed. The effect of using the band is to limit the available volume of the stomach, and thus the amount of food that can be taken before it becomes "full".

[0003] Devices for limiting consumed food also include mechanically adjustable bands that similarly surround the upper stomach. These bands contain any number of springing materials or transmission devices, as well as drive components for adjusting the bands. In addition, stomach bands have been developed that contain both hydraulic and mechanical drive components. It is also known to limit the available volume for consumed food in the stomach cavity by implanting a filled elastomeric balloon in the stomach cavity itself. The balloon is filled with fluid to expand towards the stomach wall and thereby reduce the available volume for food inside the stomach.

[0004] For each of the food restriction devices described above, safe and effective therapy requires that the device be regularly monitored and adjusted to change the degree of restriction used with respect to the stomach. Typically, the adjustment of the gastric band required a planned medical visit, during which the Huber's needle and syringe were used to pierce the patient's skin and remove the fluid from the balloon through the dosing port. Recently, implantable pumps have been developed that enable non-invasive adjustment of the band. The external controller communicates with the implanted pump using telemetry to control the pump. During the planned visit, the doctor places the manual control part near the gastric implant and transmits the control signal to the implant.

[0005] Implants, such as those described above, comprise electronic components, such as an antenna, that are used to communicate information to an external device to control the adaptation of the band. In the case of an implanted antenna, it is important to properly align with the external device to allow successful transmission of information. Correct alignment of the internal antenna with external devices can be difficult and time-consuming to power the implant and / or transfer data between them, because the antenna can change positions and directions under the skin. [0006] There is therefore a need for a system that will be able to position the antenna implanted under the skin into an external device or device placed internally.

[0007] French Patent Publication No. FR 2869466 relates to a process that consists in electrically connecting several transmitting antennas in parallel.

[0008] International patent publication number WO 2005/105001 relates to a gastric ring that has at least one receiving antenna, wherein at least one of the antennas is misaligned relative to the plane of the gastric ring, as well as an electronic device that is affixed to the annulus and which it is designed to ensure optimal use of the received energy.

[0009] US Patent No. 6,009,350 relates to an antenna device intended for an implantable medical device adapted and located in such a way as to have an increased telemetry range by using multiple antennas connected in parallel with each other and physically separated from each other.

[0010] The European patent publication EP 1992316 deals with the problem of percutaneous access to the dosing port and uses wireless position transducers in the gas filling junction assembly and in the injection syringe. The measurements provided by the transducers indicate to the doctor the location and position of the syringe relative to the dosing port.

[0011] The European Patent Publication 1704833 relates to a limiting system, such as an adjustable gastric band, to create a limitation in the patient's body and non-invasive transmission of pressure data regarding restriction to an external control device. The system includes a limiting device implanted in the patient's body to create a constraint. The system further comprises an implantable port connected to a limiting device. The port contains a working fluid to affect the size of the restriction. The system further comprises a pressure detection system connected to a working fluid for measuring the working fluid pressure and transmitting pressure measurement data to an external control device.

[0012] The European patent application EP 2095797 is part of the prior art according to art. 54 (3)

The European Patent Convention (EPC) and discloses a limiting system comprising a first housing comprising a tank formed therein and shaped to contain a fluid, and a second housing remote from and connected to allow fluids to flow from the first housing. The second housing may have a sensor, e.g. for measuring the fluid pressure. The limiting device may be connected to allow fluid flow with the first and second housing and may be adapted to create a passage restriction.

SUMMARY OF THE INVENTION [0013] The present invention relates to an implantable restraint system in the form as defined in independent claim 1. Preferred embodiments are defined in the dependent claims. In particular, an implantable limiting system is provided that includes an implantable limiting device configured to create a passage restriction, as well as an implantable housing associated with an implantable restraint device. The housing has at least one antenna that is adapted for telemetric communication with the transceiver device regardless of the rotational position of the housing with respect to the longitudinal axis of the catheter. At least one antenna runs along an axis aligned with the longitudinal axis of the catheter running from the housing. The transceiver may have various forms. For example, the transceiver device may be an external device located adjacent to the tissue surface or the transceiver may be placed on the device, which may be configured to be inserted internally in the patient's body. In one embodiment, the implantable housing can include a sensor that can be configured, for example, to measure at least one of the system and physiological parameters, and the antenna can effectively transmit the measured parameter to the transceiver. At least one antenna may also be adapted to receive energy, to power the sensor, or data, or other information.

[0014] The antenna can be located in the housing in various ways. For example, the implantable housing may include a support therein having a proximal and distal end and extending along the longitudinal axis of the catheter. In an exemplary embodiment, at least one antenna may include a plurality of antennas, each antenna being disposed around the proximal and distal end of the support and radially spaced about the support from the neighboring antenna. The antenna can be placed around the support in many configurations. For example, each of the plural antennas may be radially spaced apart from another, e.g. about 180 degrees, about 120 degrees, about 90 degrees or about 60 degrees, or using other angular values. In a further exemplary embodiment, at least one antenna may be in the form of an antenna with a cylindrical coil.

[0015] In a further embodiment, a limiting system is disclosed that comprises an implantable band formed to form a passage limitation, and a housing associated with the band and having a catheter extending therefrom, defining a longitudinal axis along its length. The implantable sensor may be configured to measure at least one of the limiting system parameter and a physiological parameter, e.g. fluid pressure in the band. At least one antenna may be associated with the housing and may be configured to emit a magnetic field towards an external device located on the tissue surface in the immediate vicinity of the housing, regardless of the position of the rotatable housing about the axis of the catheter running from the housing. The antenna can have a number of configurations,

BRIEF DESCRIPTION OF THE DRAWINGS [0016] The present invention will be better understood from the following detailed description, based on the attached drawings, in which:

Fig. 1A is a diagram of an embodiment of the food intake restriction system;

Figure 1B is a perspective view of an embodiment of a portion of the implantable food-restriction system of Figure 1A;

Fig. 2A is a perspective view of the food-restriction device of Fig. 1A; Fig. 2B schematically shows a device for restricting the food intake of Fig. 2A used around the patient's gastroesophageal junction;

Figure 3 is a perspective view of an embodiment of the dispensing port housing of Figure 1A;

Figure 4 is a perspective view of the embodiment of the sensor housing of Figure 1A;

Fig. 5 shows an embodiment of the sensor housing of Fig. 1A;

Fig. 6 schematically illustrates an embodiment of the variable resistance circuit intended for the pressure sensor of Fig. 5;

Fig. 7 is a block diagram showing an embodiment of the internal and external components of the food-restricting device of Fig. 1A; Fig. 8 is a perspective view of one embodiment of the containment system of Figs. 1A-1B, showing a sensor housing comprising a plurality of antennas located therein;

Fig. 9 is a perspective view of one embodiment of a support for supporting an antenna housed in the housing of Fig. 8;

Fig. 10 is a perspective view of a further embodiment of a support for supporting an antenna housed in the housing of Fig. 8;

Figure 11 is a perspective view of another embodiment of the antenna adapted to be placed in the sensor housing;

Figure 12 is a perspective view of the sensor housing including the antenna of Figure 11;

Fig. 13 is a perspective view of a further embodiment of the limiting system of Fig. 1A1B showing a housing including a plurality of antennas located therein; Figure 14 is a perspective view of the embodiment of the housing of Figure 13, showing a further embodiment of the antenna placed therein.

DETAILED DESCRIPTION [0017] Certain embodiments will now be described to provide a complete understanding of the principles of construction, functionality, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are shown in the attached drawings. Those skilled in the art will be aware that the devices and methods described in detail herein and in the accompanying drawings are non-limiting embodiments and that the scope of the present disclosure is determined solely by the claims. The properties shown or described in connection with one exemplary embodiment may be combined with the properties of the other embodiments. Such modifications and variants are intended to be within the scope of the present invention.

[0018] Various exemplary devices have been provided for communication with an implantable restraint system. In one embodiment, the implantable limiting system comprises a housing having at least one internal antenna that can communicate with an implantable sensor configured to measure system parameters (e.g. pressure) and / or physiological parameters. The internal antenna can be adapted to emit a magnetic field towards an external device or device placed internally irrespective of the rotation of the housing around the longitudinal axis of the catheter running from the housing to allow communication with an external device or device placed internally, e.g.

[0019] Although the present invention may be used with a number of limiting systems known in the art, FIG. 1A illustrates one exemplary embodiment of a food intake limiting system 10 when applied to a patient's body. As can be seen, the system 10 essentially comprises an implantable portion 10a and an outer portion 10b. Fig. 1B shows the implantable portion 10a outside the patient's body. As can be seen, the implantable portion 10a includes an adjustable gastric band 20 that is configured to receive around a patient's upper stomach 40 and a dosing port housing 30 that is connected allowing fluid to flow with an adjustable gastric band 20, e.g. via a catheter 50. the introduction can be used, to allow the introduction of fluid into and removal from the gastric band 20, thereby adjusting the size of the band 20, and thus the pressure exerted on the stomach 40. The dosing port 30 can thus be implanted in a site within the body that is accessible through the tissue. Typically, the insertion joints are located in the transverse abdominal region of the patient, beneath the skin and layers of adipose tissue. Surgeons often also implant dosing ports on the patient's bridge.

[0020] The inner portion 10a may also include a sensing or measuring device that is connected to allow fluids to flow with a closed fluid circuit in the implant portion 10a. In one embodiment, the detection device is a pressure sensing device configured to measure the fluid pressure of a closed fluid circuit. Although the pressure measuring device may have various forms and may be located anywhere along the inner part 10a, including inside the dosing port 30, in the embodiment shown the pressure measuring device is in the form of a pressure sensor which is housed inside the sensor housing 60 placed in the vicinity of the insertion connector 30. The catheter 50 may include a first portion that is connected between the gastric band 20 and the pressure sensor housing 60,

[0021] As can further be seen in Fig. 1A, the outer portion 10b essentially comprises a data reading device 70 that is configured to be placed on the skin surface above the pressure sensor housing 60 (which can be implanted below thick tissue, e.g. over 10 cm). ??) for non-invasive communication (as described in detail below) with the pressure sensor housing 60 and thereby obtaining pressure measurements. The data reading device 70 can optionally be electrically connected (either wireless or wired, as in this embodiment via the electric cable assembly 80), with a control box 90, which can display pressure measurements, other data obtained from the data reading device 70 and / or data alarms.

[0022] In some embodiments, the outer portion 10b may include a detection system configured to obtain data regarding one or more of the corresponding parameters, such as, for example, fluid pressure in the closed fluid circuit of the inner portion 10a. For example, the pressure in the closed fluid circuit can be measured with a Huber needle connected in fluid communication with the dosing port 30. An exemplary external pressure reading system is described in US Publication No. 2006/0211912, entitled "External Pressure-Based Gastric Band Adjustment System and Method" .

[0023] Fig. 2A illustrates in detail the gastric band 20. Although the gastric band 20 may have various forms, and furthermore various different gastric bands known in the art can be used with the present disclosure, in the embodiment shown the gastric band 20 has a substantially oblong shape with a support structure 22 having first and second opposite ends 20a, 20b that can be formed in a loop such that the ends are attached to each other. Various connection techniques can be used to connect the ends 20a, 20b to each other. In the illustrated embodiment, the ends 20a, 20b are in the form of strips that connect to each other, one being on top of the other. In a further embodiment shown, for example, in Figures 1B and 2B, the support structure at one end of the gastric band 20 may include a hole through which the second end of the gastric band 20 may be translated to connect the endings to each other. The gastric band 20 may also include a variable volume element, such as a filled balloon 24, which is placed or molded on one side of the support structure 22 and which is formed adjacent to the tissue. The balloon 24 may expand or contract in contact with the external walls of the stomach to form a regulated outlet for controlled restriction of food intake into the stomach. such as a filled balloon 24 which is placed or molded on one side of the support structure 22 and which is formed to be placed adjacent to the tissue. The balloon 24 may expand or contract in contact with the external walls of the stomach to form a regulated outlet for controlled restriction of food intake into the stomach. such as a filled balloon 24 which is placed or molded on one side of the support structure 22 and which is formed to be placed adjacent to the tissue. The balloon 24 may expand or contract in contact with the external walls of the stomach to form a regulated outlet for controlled restriction of food intake into the stomach.

[0024] A person skilled in the art will be aware that the gastric band may have a number of other forms. In addition, the various methods and devices disclosed herein are equally applicable to other types of implantable wristbands. For example, the bands are used to treat fecal incontinence, as described in U.S. Patent No. 6,461,292. The wristbands can also be used to treat urinary incontinence, as described in US Publication No. 2003/0105385. The wristbands may also be used to treat heartburn and / or acid reflux, as disclosed in U.S. Patent No. 6,470,892. The wristbands can also be used to treat impotence, as described in US Publication No. 2003/0114729.

[0025] Fig. 2B illustrates an adjustable gastric band 20 used around a patient's transesophageal joint. As can be seen, the band 20 at least essentially includes the upper portion of the stomach 40 near the connection to the patient's esophagus 42. After the band 20 has been implanted, preferably in unfilled form, in which the band 20 contains little or no fluid, the band 20 can be filled, for example using saline, to reduce the size of the mouth of the mouth. One skilled in the art will recognize that various techniques, including mechanical and electrical techniques, can be used to adjust the band 20. Fig. 2B also shows an alternative location of the detection device 41, located in the clamp 43 of the band 20.

[0026] The fluid dispensing port 30 may also have a number of forms. In the embodiment shown in Fig. 3, the dispensing port 30 has a substantially cylindrical housing with a distal or sub surface and a circumferential wall extending in a proximal direction from the bottom surface and defining a proximal opening 32. The proximal opening 32 may include a wall punctured through the needle 34 running across and providing access to the fluid reservoir (not shown in Fig. 3) formed inside the housing. The wall 34 is preferably placed in a sufficiently close position in such a way that the depth of the tank is sufficient to expose the open end of the needle, such as a Huber needle, i.e. fluid transfer may occur. The wall 34 is preferably arranged in such a way, that it will be sealed automatically after piercing through the needle and after withdrawing the needle. As can be further noted in Figure 3, the connector 30 may further include a catheter tube connecting member 36 that is connected to allow fluids to flow with the reservoir and that is adapted to be connected to the catheter (e.g., catheter 50). The person skilled in the art will be aware that the housing can be made of any number of materials, including stainless steel, titanium, ceramics, glass or polymeric materials, and the wall 34 can be similarly made of any number of materials, including silicone. which is connected allowing fluid to flow with the reservoir and which is adapted to be connected to a catheter (e.g. a catheter 50). The person skilled in the art will be aware that the housing can be made of any number of materials, including stainless steel, titanium, ceramics, glass or polymeric materials, and the wall 34 can be similarly made of any number of materials, including silicone. which is connected allowing fluid to flow with the reservoir and which is adapted to be connected to a catheter (e.g. a catheter 50). The person skilled in the art will be aware that the housing can be made of any number of materials, including stainless steel, titanium, ceramics, glass or polymeric materials, and the wall 34 can be similarly made of any number of materials, including silicone.

[0027] The reading device 70 may also have a plurality of forms, and one exemplary pressure reading device has been disclosed in detail in the also owned by the applicant US publication number 2006/0189888 and the US publication number 2006/0199997. In general, the reading device 70 may non-invasively measure the fluid pressure within the graft portion 10a, even when the pressure detection device is implanted below the coarse (at least more than 10 cm, and possibly above 15 cm) subcutaneous fat tissue. The physician may maintain the device 70 to be read facing the patient's skin in the vicinity of the location of the sensor housing 60 and / or the location of the other pressure-sensing device, obtain the detected pressure data and possibly other information as discussed above, and to observe a pressure reading (and / or other data) on the display of the control box 90. The data reading device 70 can also be attached removably to the patient, as discussed in detail below, e.g. during long-term testing, using straps , binders and other known methods. The data reading device 70 may operate through standard fabric or paper surgical sheets, and may further comprise a removable cover (not shown) that can be replaced for each patient. using strips, binders and other known methods. The data reading device 70 may operate through standard fabric or paper surgical sheets, and may further comprise a removable cover (not shown) that can be replaced for each patient. using strips, binders and other known methods. The data reading device 70 may operate through standard fabric or paper surgical sheets, and may further comprise a removable cover (not shown) that can be replaced for each patient.

[0028] According to the above description, the system 10 may also include one or more sensors for monitoring the gastric limiting system 10. The sensor (s) may be used to measure various operating parameters of the system 10, including, but not limited to, the pressure inside the system, the temperature inside the system. , the occurrence or frequency of the peristaltic pulse, the width of the peristaltic impulse, the duration of the peristaltic impulse, and the amplitude of the peristaltic pulse. In one exemplary embodiment, the system may include a sensor in the form of a pressure measuring device that connects to a closed fluid circuit and which is configured to measure fluid pressure within the system that corresponds to the size of the restriction used by the adjustable gastric band on the patient's stomach. The sensor can also be used to measure a number of other parameters, for example the number of pulses and the pulse width. In use, measurement of fluid pressure or any other system control parameter may allow the physician (or other health professional) to assess the performance of the restraint system. In the illustrated embodiment shown in FIG. 4, the pressure measuring device is in the form of a pressure sensor 62 located inside the sensor housing 60. The pressure measuring device may, however, be located anywhere within the closed circuit of the hydraulic implant part, and various exemplary locations and configurations have been disclosed in detail in the also owned by the applicant US publication number 2006/0211913, titled "NonInvasive Pressure Measurement In A Fluid Adjustable Restrictive Device", brought on March 7, 2006. Generally, the sensor housing 60 includes an inlet 60a and an outlet 60b that are connected allowing fluids to flow in the implantable portion 10a. The catheter 50 already implanted may be retrofitted with the sensor housing 60, e.g. by cutting the catheter 50 and inserting corrugated joints (or any other connectors such as clips, clips, adhesives, welding etc.) into the cut ends of the catheter 50. Sensor 62 can it may be arranged inside the housing 60 and may be configured to react to changes in pressure within the hydraulic circuit and to convert the pressure changes into a usable data form. In general, the present sensor housing 60 includes an inlet 60a and an outlet 60b that are connected to allow fluids to flow in the implantable portion 10a. The catheter 50 already implanted may be retrofitted with the sensor housing 60, e.g. by cutting the catheter 50 and inserting corrugated joints (or any other connectors such as clips, clips, adhesives, welding etc.) into the cut ends of the catheter 50. Sensor 62 can it may be arranged inside the housing 60 and may be configured to react to changes in pressure within the hydraulic circuit and to convert the pressure changes into a usable data form. In general, the present sensor housing 60 includes an inlet 60a and an outlet 60b that are connected to allow fluids to flow in the implantable portion 10a. The catheter 50 already implanted may be retrofitted with the sensor housing 60, e.g. by cutting the catheter 50 and inserting corrugated joints (or any other connectors such as clips, clips, adhesives, welding etc.) into the cut ends of the catheter 50. Sensor 62 can it may be arranged inside the housing 60 and may be configured to react to changes in pressure within the hydraulic circuit and to convert the pressure changes into a usable data form.

[0029] Different pressure sensors known from the prior art can be used as a pressure sensor 62, for example a wireless pressure sensor offered by CardioMEMS, Inc., Atlanta, Georgia, although a suitable MEMS pressure sensor (Micro-Electro-Mechanical Systems - microsystem electromechanical) can be obtained from any other source, including but not limited to Integrated Sensing Systems, Inc. (ISSYS), Ypsilanti, Michigan and Remon Medical Technologies, Inc., Waltham, Massachusetts. One exemplary MEMS pressure sensor has been described in U.S. Patent No. 6,855,115. One skilled in the art will also recognize that suitable pressure sensors may include, but are not limited to, a capacitive piezoresistive silicon strain gauge or ultrasonic (acoustic) pressure sensors,

Furthermore, the sensor housing 60 can be made of any one or more transparent (as seen in FIG. 5) opaque, translucent and radiopaque materials. The circuit board 64, including, in addition to other elements, a microcontroller 65 (e.g. a processor), may also be disposed in the housing 60 to assist the process and transfer pressure measurements collected by the sensor 62, and possibly other data associated with the band 20. (The circuit board 64 may also be part of the housing 60, as mentioned above.) As described below, the circuit board 64 may also include a Transcutaneous Energy Transfer (TET) / telemetry coil and a capacitor. Optionally, a temperature sensor can be integrated with the circuit board 64. The microcontroller 65, the TET / telemetry coil, the capacitor and / or the temperature sensor can be connected via the circuit board 64 or via any other suitable component (s). The TET / telemetry coil and the capacitor may together form a resonant circuit for taking energy from the external part 10b and transferring pressure measurements to a pressure reading device, e.g. a reading device 70. In addition, to the extent that the telemetric component associated with the pressure sensor 62 is unable to connect to a telemetry device outside the patient's body without certain assistance,

[0031] During use, fluid can enter the sensor housing 60 through an opening 66 located anywhere on the housing surface (in this case the housing bottom) and contact the sensor pressure sensing surface 68. Sensor 62 is normally sealed relative to the motherboard in such a way that fluid entering the opening 66 can not penetrate and affect the operation of the sensor 62, except for the pressure detection surface 68. The sensor 62 can measure the pressure of the fluid coming into contact with the pressure sensing surface 68 when fluid flows in and out through the opening 66. For example, the pressure detection surface 68 can include a membrane having a deformable surface such that when liquid flows through the opening 66, fluid hits the membrane surface, causing mechanical displacement of the surface. The mechanical displacement of the diaphragm can be transformed into an electrical signal through a circuit of variable resistance, containing a pair of silicon strain gauges with variable resistance. One strain gauge can be attached to the center portion of the diaphragm to measure the displacement of the diaphragm, while the other, associated strain gauge, can be attached close to the outer edge of the diaphragm. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. The mechanical displacement of the diaphragm can be transformed into an electrical signal through a circuit of variable resistance, containing a pair of silicon strain gauges with variable resistance. One strain gauge can be attached to the center portion of the diaphragm to measure the displacement of the diaphragm, while the other, associated strain gauge, can be attached close to the outer edge of the diaphragm. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. The mechanical displacement of the diaphragm can be transformed into an electrical signal through a circuit of variable resistance, containing a pair of silicon strain gauges with variable resistance. One strain gauge can be attached to the center portion of the diaphragm to measure the displacement of the diaphragm, while the other, associated strain gauge, can be attached close to the outer edge of the diaphragm. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. containing a pair of silicon strain gauges with variable resistance. One strain gauge can be attached to the center portion of the diaphragm to measure the displacement of the diaphragm, while the other, associated strain gauge, can be attached close to the outer edge of the diaphragm. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. containing a pair of silicon strain gauges with variable resistance. One strain gauge can be attached to the center portion of the diaphragm to measure the displacement of the diaphragm, while the other, associated strain gauge, can be attached close to the outer edge of the diaphragm. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. it can be attached near the outer edge of the membrane. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge. it can be attached near the outer edge of the membrane. The strain gauges can be attached to the membrane by means of binders or they can be dispersed in the membrane structure. When the fluid pressure within the band 20 changes, the surface of the membrane may deform up or down, causing a change in the resistance in the center of the strain gauge.

In particular, the first differential amplifier 102 measures the voltage across the entire perimeter of the bridge 100, while the second differential amplifier 104 measures the differential voltage on the strain gauge half of the bridge circuit 100. The greater the difference between the voltages on the strain gauge, the constant bridge voltage, the greater the pressure difference . The output signals from the differential amplifiers 102, 104 can be used by the microcontroller 65 integrated in the circuit board 64, and the microcontroller 65 can transmit the measured pressure data to a device away from the patient. If desired, a fully compensated Wheatstone bridge can also be used to increase the sensitivity and accuracy of the pressure sensor 62. In the fully compensated circumference of the sternum,

[0033] Fig. 7 depicts one embodiment of the components included in the inner and outer portions 10a, 10b. As can be seen in Fig. 7, the outer portion 10b includes a main TET coil 130 for transmitting a power signal 132 to the inner portion 10a. Also included is a telemetry coil 144 for transmitting data signals to the inner portion 10a. The main coil TET 130 and the telemetry coil 144 connect to form an external antenna, e.g. a reading device 70. The outer part 10b, e.g. placed in the control box 90, comprises a power supply circuit TET

134, the power circuit TET 134 is controlled by a microprocessor 136 having an associated memory 138. The user graphical interface 140 is connected to the microprocessor 136 to enter patient information, present data, and instructions to the physician and / or user. or printing data and instructions for the doctor. By using the user interface 140, the user, such as a patient or clinician, can forward the regulatory request to the physician, and can further indicate the reason for the request. In addition, the user interface 140 may enable the patient to read and respond to the doctor's orders and / or alarms regarding pressure measurements, as discussed in detail below.

The external part 10b also comprises a main telemetry transceiver 142 for transmitting query commands to and receiving response data, including detected pressure data, from the implanted microcontroller 65. The main transceiver 142 is electrically connected to the microprocessor 136 at to enter and receive command and data signals. The main transceiver 142 powers the telemetry coil 144 to induce resonance at the selected RF transmission frequency. The resonating circuit can generate a sub-variable magnetic field 146 that transmits command data to the microcontroller 65. Alternatively, the transceiver 142 may receive telemetry signals transmitted from the secondary TET / telemetry coil 114 in the inner portion 10a. The received data may be stored in the memory 138 associated with the microprocessor 136. Power150 may provide energy to the control box 90 to power the element (s) in the inner portion 10a. The ambient pressure sensor 152 is connected to the microprocessor 136. The microprocessor 136 may use the signal from the ambient pressure sensor 152 to adjust the received pressure measurements in the event of changes in atmospheric pressure, e.g. due to changes in barometric conditions or altitude to increase the accuracy of the pressure measurements.

[0035] Fig. 7 also shows components of the inner part 10a, which in this embodiment are housed in the sensor housing 60 (e.g. on the circuit board 64). As can be seen in FIG. 7, the auxiliary telemetry coil TET receives the power / communication signal 132 from the external antenna. The auxiliary coil 114 forms a tank resonance circuit that is inductively coupled to the main TET 130 coil to supply the implant or main telemetry coil 144 to receive and transmit data. The telemetric transceiver device 158 controls the data exchange with the secondary coil 114. In addition, the inner part 10a includes a rectifier / power controller 160, a microcontroller 65, memory 162 associated with the microcontroller 65, a temperature sensor 112, a pressure sensor 62, and a signal enhancement circuit 164. The implanted components may transmit the results of the pressure measurement (with or without adjustment due to temperature, etc.) from the sensor 62 to the control box 90 via the antenna (main coil TET 130 and telemetry coil 144). The pressure measurements can be stored in the memory 138, adapted to the ambient pressure, presented on the display on the control box 90 and / or transmitted, if possible in real time, to the remote monitoring station in a location away from the patient.

[0036] According to the above description, the sensor housing may comprise at least one antenna that may be used to enable the supply of the implantable restraint system 10 by and / or communicate with an external device or device placed internally. The antenna is placed in the housing in such a way as to allow effective communication between the antenna and the external device adjacent to the skin surface or a device configured to be placed inside the patient's body, e.g. in the gastrointestinal tract. In particular, the antenna is arranged in the housing to allow the antenna to emit a magnetic field towards the external device or device placed internally, regardless of the position of the rotatable housing about the longitudinal axis of the catheter. You can do it,

[0037] Although the housing that includes the antenna, e.g. the sensor housing 60 described above, is shown in Figure 1B as having a disc-like configuration and in Figure 4 in the form of a longitudinal configuration, the housing can have a variety of shapes, including round and rectangular . In one exemplary embodiment shown in Fig. 8, the housing 200 can have a substantially oblong cylindrical shape, having a proximal and distal end 200p, 200d that define a longitudinal axis therebetween. One skilled in the art will recognize that the housing 200 may be of any shape and size, but is preferably configured to be implanted into the tissue and include at least one antenna 204 disposed therein. The housing 200 may further include a catheter extending therefrom. such as a catheter 50. The catheter 50 may be connected to the housing by using an inlet and / or outlet that are connected to allow fluids to flow in the implantable portion 10a. To enable efficient communication between the antenna 204 and the external device, the antenna 204 extends within the housing 200 along the axis A aligned with the longitudinal axis of the catheter 50. A skilled person will appreciate that alignment of the antenna 204 with the longitudinal axis of the catheter 50 includes an antenna 204 that is coaxial. z or parallel to the longitudinal axis of the catheter 50. Thus, regardless of the rotation of the housing 200 about the longitudinal axis of the catheter 50, the antenna 204 may emit a magnetic field towards a predetermined location on the tissue surface to allow communication of the antenna 204 with the external device. The expert in this field will be aware, that the housing 200 can have any configuration provided that the antenna 204 can be placed inside it. In addition, one skilled in the art will recognize that although the casing and catheter are shown aligned in line with the present disclosure, the components may be arranged in a variety of other ways that are not consistent with the present invention, including using a T configuration or configuration Y, and various example configurations have been disclosed in detail in the applicant's US publication number 2006/0211913, entitled "Non-Invasive Pressure Measurement In A Fluid Adjustable Restrictive Device", filed March 7, 2006.

[0038] The housing 200 may also include an electrical circuitry as described above in Figure 5, which may be housed in a housing in a variety of ways. For example, in an exemplary embodiment, the circuitry may be mounted in the housing 200 using a connecting member 208 that is configured to connect the circuitry to the proximal end 200p of the housing 200. The skilled person will note, however, that the circuitry may be disposed in the housing. 200 in any fashion and may be attached to housing 200 using any known means.

[0039] At least one antenna 204 may also be disposed within the housing 200 in a number of ways. In one embodiment, the housing 200 may include a support 202 configured to support the antenna 204. The support 202 may have a variety of shapes and further include a proximal and distal end 202p, 202d that define a longitudinal axis therebetween that is parallel to or coaxial with the longitudinal axis of the catheter 50 extending from the housing 200. In the embodiment shown, the proximal end 202p of the support 202 is connected to the proximal end 200p of the housing 200 using a fastener 206 that is configured to connect the support 202 to the inner proximal wall of the housing 200. expert in this field will notice, however, that the support 202 can be connected to the housing 200 using various techniques. For example, the support 202 can be permanently connected to the housing 200, e.g. using adhesives or fasteners or the support 202 can be detachably connected to the housing 200. One skilled in the art will recognize that the support 202 can be connected to a housing 200 in any way that allows the antenna 204 to be positioned along the support 202. The support 202 may also include means for accommodating any number of antennas 204 arranged in any manner along the support 202, as will be described in more detail below.

[0040] In order to facilitate communication with a device, such as a transceiver device, which may be an external device or device designed to be placed inside the body, e.g. in the gastrointestinal tract, the housing 200 may include any number of antennas 204 in different configurations in order to emitting and / or receiving field lines that are directed to the tissue surface regardless of the orientation of the housing 200 about the axis of the catheter 50 extending from the housing 200. In one exemplary embodiment, this allows the antenna 204 to communicate with any device, including external devices, and internal, regardless of the orientation of the housing 200 about the axis of the catheter 50 extending from the housing when the housing 200 rotates and / or jumps about the axis of the catheter 50 when it is implanted. An expert in the field will notice

[0041] For example, in one exemplary embodiment, the housing 200 may include a plurality of antennas 204 arranged around proximal and distal ends 202p, 202d of support 202 and radially spaced apart to emit field lines, which allows antennas 204 to communicate with an external device. The plurality of antennas may be radially spaced apart according to any angular increments, e.g. about 180 degrees, 120 degrees, 90 degrees, 60 degrees, 30 degrees or according to a different increment. In the exemplary embodiment of Fig. 8, the first, second and third antennas can be wound around support 202, running along its longitudinal axis, and are radially spaced about 120 degrees apart. In other words, each of the first, second and third antennas may have a first part,

[0042] The support may also have a variety of shapes for supporting a plurality of antennas arranged radially around it. For example, FIG. 9 shows one exemplary embodiment of a support 222 adapted to support the first and second antennas. The first and second antennas can be wound around support 222, running along its longitudinal axis, and can be radially spaced about 180 degrees apart. In other words, each of the first and second antennas may have a first portion running along the side 220, 224 of the support 222 and a second portion extending along the opposite side 226, 228 of the support 222. In this way, each of the first and second antenna parts is spaced apart from each other. by 90 degrees. In order to place the first and second antennas, the support 222 may have a substantially elongated shape with a cross-shaped cross-section. The support 222 may also include first and second opposed mounting grooves 230, 232 that face each other along sides 220, 228 of the support 222 to hold the first antenna, and third and fourth mounting grooves 234, 236 that face each other and 90 degrees to the first and second mounting grooves 230, 232 opposite each other along the sides 224, 226 of the support 222 to hold the second antenna. The assembly grooves 230, 232, 234, 236 may have a number of configurations, but in the embodiment shown, they are formed by channels formed along the lengths 220, 224, 226, 228 of the support 222 and are sized and shaped to hold the first and second antennas inside. . Each assembly groove 230, 232, 234, 236 may comprise first and second opposite side wall 230a, 230b, 232a, 232b, 234a, 234b, 236a, 236b, and further the side walls may have a height that prevents the antenna from sliding out of the mounting grooves 230, 232, 234, 236 to hold the first and second antennas in place. One skilled in the art will recognize that the support 222 may have a series of configurations for supporting the first and second antennas. For example, the support 222 may be in the form of an elongated rectangle (not shown) having four sides with mounting grooves 230, 232, 234, 236 formed in each of the sides of the longitudinal rectangle. In addition, one skilled in the art will recognize that the support 222 can support the antenna without using mounting grooves. 236 to keep the first and second antennas in place. One skilled in the art will recognize that the support 222 may have a series of configurations for supporting the first and second antennas. For example, the support 222 may be in the form of an elongated rectangle (not shown) having four sides with mounting grooves 230, 232, 234, 236 formed in each of the sides of the longitudinal rectangle. In addition, one skilled in the art will recognize that the support 222 can support the antenna without using mounting grooves. 236 to keep the first and second antennas in place. One skilled in the art will recognize that the support 222 may have a series of configurations for supporting the first and second antennas. For example, the support 222 may be in the form of an elongated rectangle (not shown) having four sides with mounting grooves 230, 232, 234, 236 formed in each of the sides of the longitudinal rectangle. In addition, one skilled in the art will recognize that the support 222 can support the antenna without using mounting grooves. 234, 236 formed in each of the sides of the longitudinal rectangle. In addition, one skilled in the art will recognize that the support 222 can support the antenna without using mounting grooves. 234, 236 formed in each of the sides of the longitudinal rectangle. In addition, one skilled in the art will recognize that the support 222 can support the antenna without using mounting grooves.

[0043] In a further exemplary embodiment, the first, second and third antennas 304a, 304b, 304c may be spaced radially about 120 degrees apart. As can be seen in Fig. 10, the support 302 may be configured to hold the first, second and third antennas and may have a substantially hexagonal shape having six sides. Each pair of opposed sides of the support 302 may hold the first, second and third antennas 304a, 304b, 304c along its length such that the antenna segments are spaced apart from each other by an angle of about 60 degrees. One skilled in the art will recognize that the support 302 may have a variety of shapes and comprise a series of additional elements for supporting the first, second and third antennas 304a, 304b, 304c. For example, the support 302 may include mounting grooves as described above with reference to FIG. to allow communication between the antenna 304a, 304b, 304c and the external or internal device. [0044] One skilled in the art will recognize that the antenna may have any configuration and may be configured to emit a field in all directions. For example, the antennas shown in Figs. 8-10 are configured to emit a field in all directions due to the antenna being wound around the ends of the support. Although the field emitted from the antenna ends may be weaker than the field emitted from the antenna part, running along the length of the antenna support, these antenna configurations will emit a field in all directions. In a further exemplary embodiment, in order to obtain an antenna that emits a substantially uniform field in all directions, the antenna can be arranged to have a symmetrical configuration, for example in the shape of a cube.

[0045] In a further exemplary embodiment, as can be seen in Figs. 11-12, the antenna may be in the form of a cylindrical coil 404 having a longitudinal axis A that is aligned with the longitudinal axis of the catheter 50 extending from the housing 400. Antenna 404 the cylindrical coil has a length and a diameter that are configured to allow the antenna 404 to be housed within the housing 400, and may have a number of configurations. For example, the coil antenna 404 may be formed of a single continuous antenna 404 in helical configuration or it may be formed of a plurality of separate circular antennas located close to each other to form a helical shape. The support 402 may be configured to support the antenna 404 with a cylindrical coil, and in the embodiment shown in the form of a longitudinal surface having a size, which allows placement of support 402 in antenna 404 with a cylindrical coil. The support 402 may have a length that permits the support 402 to extend over the entire length of the antenna 404 and allows connection of the support 402 to the housing 400. The support 402 may be connected to the housing in a number of ways. For example, in the embodiment shown, the support 402 can be connected to the proximal inner wall of the housing 400 using a fastener 406. The circuitry 408 located inside the housing 400, as described above, can also be attached to the housing 400 using a fastener 406. One skilled in the art will recognize that the circuitry 408 can be attached to the housing in a variety of ways, including using a separate fastener. In the illustrated embodiment, the fastening element 406 comprises first and a second elongation extending therefrom. The first extension is configured to be connected to the support 402 to connect the support 402 to the fastener 406, and the second extension is configured to connect to the circuitry 408 to connect the circuitry 408 to the fastener 406. To facilitate communication with the external device, the field lines generated through the antenna 404 with the cylindrical coil, run substantially parallel to the longitudinal axis of the catheter 50, allowing communication with the external device regardless of the position of the rotatable housing 400 about the axis of the catheter 50 extending therefrom.

enabling communication with an external device or indoor device regardless of the rotary position of the housing around any axis. One skilled in the art will recognize that the antenna can be located within any enclosure in the bounding system to allow communication of the antenna with an external device or device placed internally.

[0047] In use, the restraint system 10 shown in Figs. 1A-1B can be implanted under the skin using techniques known in the art. For example, the gastric band 20 may be inserted into the patient's body and placed around the stomach to restrict passage to the stomach, thereby limiting food intake. The housing 60 (or 200, 400) and the port 30 can be implanted into the tissue, preferably in the fascia, and can be connected to the band 20 to allow fluid flow between them. Preferably the port 30 is attached to the fascia surface, e.g. in such a way that the port 30 is substantially parallel to the skin surface to allow access to the port 30. The housing 60, 200, 400, which is spaced apart from the port 30 and preferably located on the fascia. , can be connected to port 30 using a catheter 50.

[0048] After implantation, it is necessary to allow communication with the implant part 10a of the containment system 10, for example, to transfer energy to the limiting system and / or to forward system information to and from the limiting system 10. The antennas are configured inside the housing, e.g. the sensor housing or a dispensing port, in any of the configurations described above to facilitate communication with an external device. The lines of the magnetic field emitted and / or received by the implanted antenna are emitted and / or received in such a way as to allow communication of the external antenna on the external device or internal antenna on the device placed internally with the implanted antenna, regardless of the position of the antennas and the housing in which they are they are arranged around any axis.

[0049] The devices disclosed herein may be designed to be removed after one use or may be designed to be used repeatedly. However, in any case, the device may be regenerated for reuse after at least one use. The regeneration may comprise any combination of steps of dismantling the device, cleaning or replacing individual elements, and then reassembling. In particular, the device may be dismantled and any number of individual elements or parts of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing individual parts, the device can be refolded, for further use in a regeneration plant or surgical team immediately before surgery. Those skilled in the art will appreciate that the regeneration of the device may include a variety of different techniques for disassembling, cleaning / replacing elements and reassembling. The use of such techniques as well as the resulting regenerated device is within the scope of the present disclosure.

[0050] Preferably, the invention described herein will be prepared prior to surgery. First, a new or used device is obtained and cleaned if necessary. The device can then be sterilized. According to one of the sterilization techniques, the device is placed in a closed and sealed package, such as a plastic or TYVEK bag. The packaging and device are then placed in a radiation field that can penetrate the package, such as gamma radiation, X-rays or electron radiation with increased energy. Radiation destroys the bacteria on the instrument and in the packaging. The sterilized device can then be stored in a sterile package.

[0051] It is advantageous to carry out the sterilization of the device. This can be accomplished using any method known to those skilled in the art, including beta or gamma radiation, sterilization with ethyl acetate or steam. One of ordinary skill in the art will appreciate further features and advantages of the present invention based on the embodiments set out above. Accordingly, the invention should not be limited to what has been specifically shown and described, except as indicated in the appended claims.

26842 / PE / 16 EP2103285