External pressure-based gastric band adjustment system and method

Contents of disclosure

[priority] This application is incorporated herein by reference in this specification. Simultaneous continuation of the application on February 24, 2005, US Non-Provisional Patent Application No. 11 / 065,410 (Name: "Pressure of fluid in adjustable limiting device". This is a partial continuation application of "Device for Non-Invasive Measurement of Fluid Pressure in an Adjustable Restriction Device").

[Field of invention] Embodiments of the present invention relate to a limiting device for implantation, and more particularly to a fluid-filled limiting device. Embodiments of the present invention also relate to food intake restriction devices for the treatment of morbid obesity.

[Background of invention] Various devices and methods for treating obesity have been developed and used, including, but not limited to, adjustable gastric bands. An example of such an adjustable gastric band is US Pat. No. 6,067,991, granted May 30, 2000, which is incorporated herein by reference (name: "Mechanical Food Intake Restriction". It is disclosed in Device) "). If the adjustable gastric band system is fluid, those skilled in the art will appreciate that it is advantageous to obtain data representing the pressure of the fluid in the gastric band system. Similar benefits would be obtained with fluid-filled components implanted in the gastric cavity or elsewhere. Such pressure data can be obtained before, during, and / or after pressure regulation and may be useful for regulation, diagnosis, monitoring, or other purposes. The above examples are merely examples and are not exhaustive. Although various techniques and devices have been used in the treatment of obesity, it is believed that no one other than the inventor has made or used the invention disclosed in the appended claims.

[Outline of Invention] In one aspect, the external pressure detection system includes a connecting member that can be coupled to the syringe barrel. The connecting member can be further connected to the needle. The connecting member includes a syringe barrel and a conduit that, when connected to the needle, allows fluid to pass from the syringe barrel to the needle. The pressure detection system also includes a pressure sensor with fluid communication through this conduit. The pressure sensor is configured to detect the pressure of the fluid in the connecting member. The connecting member is configured so that the pressure sensor can detect the pressure of the fluid while it communicates from the barrel to the needle.

In another aspect, the external pressure detection kit includes a syringe and a pressure detection system. The syringe includes a barrel, a plunger configured to fit at least partially within the barrel, and a needle. The pressure sensing system includes a generally T-shaped member configured to fit between the barrel and the needle. The generally T-shaped member defines a flow path configured to allow fluid communication from the barrel to the needle. The pressure detection system is configured to detect the pressure of the fluid in the pressure detection system as the fluid flows from the barrel to the needle or from the needle to the barrel when a T-shaped member is mounted between the barrel and the needle. Further includes a pressure sensor. The pressure detection system further includes a communication device connected to the pressure sensor. This communication device can send the data obtained by the pressure sensor to the data processor.

In yet another aspect, the method for externally measuring the pressure of the fluid in the implanted device comprises the step of preparing a syringe assembly. This syringe assembly has a syringe barrel containing fluid. The syringe assembly also includes a plunger that is at least partially located within the barrel. The syringe assembly also includes a needle that communicates fluidly with the barrel. The method also includes providing an external pressure sensor with fluid communication to the syringe assembly. This external pressure sensor is located outside the patient. The method also includes the step of inserting the needle of the syringe assembly into the patient's body. The needle is inserted into a fluid injection port located inside the patient's body. The fluid injection port contains the fluid. The method also includes the step of adjusting the pressure of the fluid in the injection port. This adjusting step includes pushing or pulling the plunger against the syringe barrel to add or remove fluid to the injection port. The method also includes the step of obtaining pressure data with an external pressure sensor. The pressure data relates to the pressure of the fluid communicating from the barrel to the needle. The step of obtaining pressure data and the step of adjusting the pressure of the fluid in the injection port are performed substantially at the same time.

Other examples, features, embodiments, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which, for illustrative purposes, is considered to be one of the best modes for carrying out the present invention. There will be. Of course, the present invention is capable of all other distinct aspects without departing from the present invention. Therefore, the accompanying drawings and the following statements should be construed as exemplary and not restrictive.

Although the present specification is conclusive within the scope of the claims that demonstrate and clearly claim the invention, the invention can be better understood by reading the following detailed description with reference to the accompanying drawings. Will. In all attached drawings, similar elements are labeled with similar reference numerals.

[Detailed explanation] The specific examples described below of the present invention should not be construed as limiting the scope of the present invention. Other examples, features, embodiments, embodiments, and advantages of the present invention will become apparent from the following description, which is an example that would be considered by one of ordinary skill in the art to be one of the best methods for carrying out the present invention. There will be. Of course, the present invention is possible without deviating from the present invention in all other various distinct aspects. Therefore, it should be interpreted that the accompanying drawings and the following description are for illustrative purposes only and not for limiting purposes.

See the drawing here. In all drawings, similar reference numerals indicate similar elements. FIG. 1 illustrates the food intake restriction system 30. The system 30 includes a first portion 32 implanted inside the patient 34 and a second portion 36 located outside the patient's body. The implant portion 32 includes an adjustable stomach band 38 located above the patient's stomach 40. The adjustable stomach band 38 can include a cavity made of silicone rubber or another type of biocompatible material that expands inward with respect to the stomach 40 when filled with fluid. Alternatively, the band 38 can include a mechanically adjustable device having a fluid cavity whose pressure changes with the adjustment of the band, or an adjustable band that is a combination of fluid and mechanical. The injection port 42, which will be described in detail later, is implanted at a site in the body that is accessible during needle injection and / or telemetry communication signals. In the illustrated embodiment, the infusion port 42 communicates with an adjustable band 38 via a catheter 44. The surgeon can place the infusion port 42 inside the patient's body and implant it permanently to adjust the food intake restriction or opening. Those skilled in the art will appreciate that recent advances in surgical methods for placing gastric band systems such as implant 32 allow patients to obtain optimal therapeutic effects with minimal complications. For example, surgeons typically implant an infusion port 42 in the area below the lateral ribs below the skin and fat layer of the patient's abdomen. The surgeon can also implant an injection port 42 in the patient's sternum.

FIG. 2 illustrates in detail an exemplary adjustable gastric band. In this embodiment, the band 38 includes a variable volume cavity 46 that expands and contracts with respect to the outer wall of the stomach, forming an adjustable opening for controlling the restriction of food intake into the stomach. The physician can add fluid to the variable volume cavity 46 to reduce the opening, or remove fluid from the cavity to increase the opening. The fluid can be added or removed by inserting a needle into the injection port 42. Alternatively, the fluid can be transferred non-invasively between band 38 and injection port 42 using a telemetry command signal. The fluid can be, but is not limited to, 0.9% saline.

FIG. 3 shows the adjustable gastric band 38 of FIG. 2 mounted around the junction of the patient's stomach and esophagus. As shown in FIG. 3, the band 38 at least substantially surrounds the upper part of the stomach 40 near the junction with the esophagus 48. FIG. 4 is a cross-sectional view of a band 38 showing a band in a contracted structure. In this figure, the band 38 contains almost no fluid, so that the size of the mouth opened to the stomach 40 is maximized. FIG. 5 is a cross-sectional view of a band 38 and a stomach 40 similar to FIG. 4, showing a band 38 in an inflated, fluid-filled structure. In this figure, the fluid in the band increases the pressure of the band 38 against the stomach 40, which reduces the opening and limits food intake. FIG. 5 also schematically illustrates the dilation of the esophagus 48 above the band 38 forming the upper sac 50 underneath the patient's diaphragm muscle 52.

See Figure 1 again. The extracorporeal portion 36 of the food restriction system 30 includes a pressure reader 60 (using an electrical cable assembly 62 in this embodiment) electrically connected to a control box 64. The control box 64 includes a display 66, one or more control switches 68, which will be described in detail later, and an external control module. The control box 64 can be configured for use, for example, in a doctor's office or laboratory. The control box 64 can be mounted on a desktop, mounted on a laboratory table, or hung on a portable stand. The control box 64 can also be structured so that it can be placed in the pocket of a doctor's lab clothes, grabbed by hand, or placed on an examination table or a lying patient. The electrical cable assembly 62 can be detachably connected to the control box 64 or the pressure reader 60 to facilitate cleaning, maintenance, use, and storage of the external 36 of the system 30. The pressure reader 60 can non-invasively measure the pressure of the fluid within the implantation site 32, even if the injection port 42 is implanted underneath a thick subcutaneous adipose tissue (at least> 10 cm). .. The physician can hold the pressure reader 60 against the patient's skin near the location of the injection port 42 to see the pressure measurements displayed on display 66 of the control box 64. The pressure reader 60 can also be detachably attached to the patient using strings, adhesives, and other well-known methods if the examination takes a long time. The pressure reader 60 can also include a disposable cover (not shown) that can be operated via a conventional cloth or surgical paper drape and can be replaced on a patient-by-patient basis.

See Figure 6 here. FIG. 6 is a partial side sectional view of the injection port 42 including a pressure sensing system for non-invasively measuring fluid pressure in the implantable portion 32. As shown in FIG. 6, the injection port 42 includes a rigid housing 70 with an annular flange 72. The annular flange 72 includes a plurality of mounting holes 74 for mounting the injection port to the patient's tissue. The surgeon can attach the injection port 42 to tissue such as the fascia that covers the abdominal muscles using one of a variety of surgical fasteners, including sutures, staples, and clips. The injection port 42 further includes a bulkhead 76 that is held in a compressed state within the housing 70, usually made of silicone rubber. The septum 76 can be inserted by a Huber needle or similar type of infusion device to inject or withdraw fluid from the port. The septum 76 automatically seals when the needle is pulled out to maintain the volume of fluid in the injection port 42. The infusion port 42 also includes a reservoir 80 and a catheter connector 82 to receive the working fluid. Connector 82 is attached to catheter 44 as shown in FIG. 2 to establish a closed fluid circuit between the reservoir 80 in the infusion port 42 and the cavity 46 in the adjustable band 38. The fluid of the reservoir 80 can be used to inflate the volume of the band cavity 46. Alternatively, fluid can be drawn from the cavity 46 and retained in the reservoir 80 to temporarily reduce the volume of the cavity 46. The housing 70 and connector 82 can be integrally molded from a biocompatible polymer or formed from a metal such as titanium or stainless steel.

A pressure sensing system is provided in the injection port 42 to measure the fluid pressure in the closed fluid circuit of the implant portion 32. The pressure in the circuit corresponds to the degree of restriction imposed on the patient's stomach by the adjustable band 38. Therefore, by measuring the fluid pressure, the physician can assess the limits created by band adjustment. Fluid pressure can be measured before, during, and / or after band adjustment to assess whether the band is properly adjusted. In the embodiment shown in FIG. 6, the pressure sensing system includes a sensor 84 located at the bottom of the fluid reservoir 80 in the housing 70. A holding cover 86 covers the pressure sensor 84, substantially separating the surface of the sensor from the reservoir 80 and protecting the sensor from needle sticks. The holding cover 86 can be formed from a ceramic material such as alumina that can withstand needle insertion and does not interfere with the electrical connection between the pressure sensor 84 and the pressure reader 60. The holding cover 86 includes a vent 90. By this vent 90, the fluid in the reservoir 80 flows to the surface of the pressure sensor 84 and comes into contact with this surface.

FIG. 7 is an isometric view of the holding cover 86 illustrating the vent 90 on the bottom surface of the holding cover 86. FIG. 8 is an external isometric view of the pressure sensor 84. As shown in FIG. 8, the exterior of the pressure sensor 84 includes a strain element with a deformable surface. In the illustrated embodiment, this strain element is the diaphragm 92. The diaphragm 92 can be formed by thinning a part of the wall portion of the titanium reservoir 80. The diaphragm 92 can be formed from titanium or another similar material and has a thickness of 0.0254 mm to 0.0508 mm (0.001 inch to 0.002 inch). Although the diaphragm is shown as a strain element in embodiments, the invention can also be constructed and practiced with other strain elements that convert fluid pressure into mechanical displacement. Examples of other suitable strain elements include, but are not limited to, Bourdon tubes and bellows assemblies. The pressure sensor 84 is hermetically sealed inside the housing 94 to prevent fluid from entering and affecting the operation of the sensor. The housing 94 is sealed to the port housing 70 to prevent fluid from flowing out of the injection port 42. The diaphragm 92 is hermetically sealed to the sensor housing 94 to prevent fluid from flowing around the edges of the diaphragm 92 into the internal elements of the detection system. As the fluid flows into the reservoir 80 through the vent 90, it presses against the surface of the diaphragm 92. As the fluid flows into the vent 90, the diaphragm 92 can convert this change in fluid pressure into a mechanical displacement in response to a change in fluid pressure in the fluid circuit.

FIG. 9 is a side sectional view of the pressure sensor 84 cut along line AA of FIG. 8 illustrating a first embodiment 88 for measuring fluid pressure. In the embodiment shown in FIG. 9, the mechanical displacement of the diaphragm 92 is converted into an electrical signal by a pair of variable resistance silicon strain gauges 96, 98. The strain gauges 96 and 98 are attached to the diaphragm 92 on the opposite side of the reservoir 80 from the working fluid. The strain gauge 96 is attached to the central portion of the diaphragm 92 to measure the displacement of the diaphragm. The second matching strain gauge 98 is mounted near the outer edge of the diaphragm 92. The strain gauges 96, 98 can be attached to the diaphragm 92 with an adhesive or dispersed within the diaphragm structure. As the fluid pressure in the band 38 changes, the surface of the diaphragm 92 deforms up or down within the surface of the housing 94. This deformation of the diaphragm 92 changes the resistance of the central strain gauge 96.

As shown in FIG. 10, strain gauges 96, 98 constitute the upper two resistance elements of the semi-compensated Wheatstone bridge circuit 100. When the strain gauge 96 reacts to the mechanical displacement of the diaphragm 92, the fluctuating resistance of the gauge changes the anterior-posterior potential of the upper part of the bridge circuit. The strain gauge 98 matches the strain gauge 96 and insulates the Wheatstone bridge circuit. Differential amplifiers 102, 104 are connected to the bridge circuit 100 to measure the change in potential in the bridge circuit by the variable resistance strain gauge. Specifically, the differential amplifier 102 measures the voltage before and after the entire bridge circuit, and the differential amplifier 104 measures the differential voltage before and after the strain gauge, which is half of the bridge circuit 100. If the difference between the voltages of the strain gauges is large with respect to the fixed voltage over the bridge, the pressure difference is also large. If desired, a fully compensated Wheatstone bridge circuit can also be used to increase the sensitivity and accuracy of the pressure sensing system. In a fully compensated bridge circuit, not only two strain gauges, but four strain gauges are mounted on the surface of the diaphragm 92 as shown in FIG.

The output signals from the differential amplifiers 102 and 104 are supplied to the microcontroller 106. The microcontroller 106 is built into the circuit board 110 in the housing 94. The temperature sensor 112 measures the temperature inside the implanted port and inputs a temperature signal to the microcontroller 106. The microcontroller 106 uses the temperature signal from the sensor 112 to compensate for the unconsidered residual temperature error due to the strain gauge 98 and fluctuations in body temperature. By compensating for the pressure measurement signal against fluctuations in body temperature, the accuracy of the pressure detection system can be improved. In addition, the TET / telemetry coil 114 is located within the housing 94. The coil 114 is connected to the capacitor 116 to form a tuning tank circuit for receiving power from the extracorporeal portion 36 and transmitting the pressure measurement to the pressure reader 60.

FIG. 11 is a side sectional view similar to FIG. 9 showing a second embodiment 118 of the pressure detection system of the present invention. In a second embodiment 118, a MEMS sensor 120 is placed in the housing 94 to measure the mechanical displacement of the diaphragm 92 and generate an electrical signal proportional to the pressure in the adjustable band 38. There is. A sealed silicone oil chamber 122 is located between the diaphragm 92 and the MEMS sensor 120. The silicone oil chamber 122 protects the MEMS sensor 120 and transmits the mechanical displacement of the diaphragm 92 to the sensor. The MEMS sensor 120 outputs an electric signal indicating the fluid pressure in the reservoir 80 to the microcontroller 106. The microcontroller 106 receives the signal from the MEMS sensor 120 and the temperature signal from the temperature sensor 112 and calculates the pressure measurement value. This pressure measurement is transmitted to the pressure reader 60 of the extracorporeal portion 36 using a telemetry signal, the details of which will be described later.

FIG. 12 is a block diagram of the pressure measurement system of the first and second embodiments 88 and 118 of the present invention. As shown in FIG. 12, the external control module 126 of this system includes a primary TET coil 130 for transmitting power signals to the internal control device 132. The primary TET coil 130 is located within the pressure reader 60 shown in FIG. The TET drive circuit 134 controls the supply of power signals to the primary TET coil 130. The TET drive circuit 134 is controlled by a microprocessor 136 having associated memory 138. The graphical user interface 140 is connected to the microprocessor 136 to control the data displayed on the display 66. The external control module 126 also includes a primary telemetry transceiver 142 to send an inquiry command to the implanted control module 132 and receive response data including fluid pressure measurements from the implanted control module 132. The primary transceiver 142 is electrically connected to the microprocessor 136 to input instructions and receive data signals. The primary transceiver 142 resonates at the selected RF communication frequency to generate a downlink alternating magnetic field 146 that transmits instruction data to the implanted control module 132. The power supply 150 supplies energy to the external control module 126 to power the system 30. The ambient pressure sensor 152 is connected to the microprocessor 136. The microprocessor 136 uses the signal from the ambient pressure sensor 152 to adjust the pressure measurement value against the fluctuation of the atmospheric pressure due to the pressure condition or the fluctuation of the altitude in order to improve the accuracy of the pressure measurement value.

FIG. 12 also illustrates an internal control module 132 implanted underneath the patient's skin 154. The internal control module 132 is located within the housing 94 of the injection port 42. As shown in FIG. 12, the secondary TET / telemetry coil 156 in the internal control module 132 receives power and communication signals from the external control module 126. The coil 156 constitutes a tuning tank circuit that is inductively coupled to the primary TET coil 130 to power the implant or is inductively coupled to the primary telemetry coil 144 to receive and transmit data. The telemetry transceiver 158 controls data exchange with the coil 156. In addition, the internal control module 132 is for amplifying signals from the rectifier / power regulator 160, the microcontroller 106 described above, the memory 162 associated with the microcontroller, the temperature sensor 112, the pressure sensor 84, and the pressure sensor. Includes signal processing circuit 164. The internal control module 132 transmits the temperature control pressure measurement value from the pressure sensor 84 to the external control module 126. The external control module 126 adjusts the received pressure measurement signal for fluctuations in ambient pressure and displays it on the display 66.

FIG. 13 is a side sectional view showing a third embodiment 170 for measuring a fluid pressure according to the present invention. In a third embodiment 170, the internal control module 132 is powered by an internal power source, such as a battery 172. The battery 172 is an alternative to the primary and secondary TET coils 130, 156 for powering the microcontroller 106 and other internal elements. In this embodiment, the pressure sensing system includes a pair of strain gauges 96, 98 similar to the first embodiment 88 for measuring the mechanical displacement of the diaphragm 92 corresponding to the pressure change in the band 38. Strain gauges 96, 98 are incorporated in a thermally compensated equilibrium bridge circuit to measure the differential pressure in the implant's closed fluid circuit.

FIG. 14 is a block diagram of the pressure measuring system of the present invention according to the third embodiment 170 shown in FIG. In embodiment 170, an internal power source is used to power the internal control module 176 instead of the TET power system of the first embodiment. The power source for the implant 32 is the battery 172 rather than the TET primary coil 130 and secondary coil 156 shown in FIG. In the embodiment illustrated in FIG. 14, the implanted secondary coil 156 is used exclusively for data communication between the internal control module and the external control module. The power regulator 174 is provided to control the power from the battery 172 in order to extend the life of the battery.

FIG. 15 illustrates a fourth embodiment 180 for measuring fluid pressure within an adjustable band 38. In this fourth embodiment, a passive system is used to measure pressure changes in the working fluid. Also, in this fourth embodiment 180, a variable capacitance 182 is attached to the diaphragm 92 to measure the mechanical displacement of the diaphragm. The variable capacitance 182 includes a first plate 184 mounted near the center of the diaphragm 92 on the opposite side of the fluid reservoir 80. A second capacitor plate 186 is secured in place within the housing 94 by a capacitor mount 188. The capacitor plates 184 and 186 are connected to the inductance coil 190 to form a resonant circuit, as indicated by the wire 192. For example, when the fluid pressure in the reservoir 80 rises or falls due to a change in the peristaltic pressure with respect to the band 38, the position of the capacitor plate 184 fluctuates with the deformation of the diaphragm 92. When the pressure of the fluid rises, the diaphragm 92 presses the first capacitor plate 184 close to the second capacitor plate 186, so that the capacitance increases and the resonance frequency decreases. Similarly, when the fluid pressure in the closed implant circuit drops, the first capacitor plate 184 moves with the diaphragm 92 away from the second plate 186, reducing the capacitance in the resonant circuit and reducing the resonant frequency. Rise.

FIG. 16 shows a fifth embodiment 196 for measuring fluid pressure according to the present invention. Fifth embodiment 196 is an alternative embodiment of a passive pressure detection system in which the variable inductance coil 200 converts the mechanical displacement of the diaphragm 92 into a pressure measurement signal. As shown in FIG. 16, the inductance coil 200 is a flat coil located below the diaphragm 92. The fixed capacitance 202 is connected to the inductance coil 200 to form the LC resonant circuit 206, as shown by wire 204. As the diaphragm 92 deforms up or down in response to fluctuations in the pressure of the working fluid, the inductance of the coil 200 fluctuates. As the fluid pressure increases, the diaphragm 92 deforms in the direction of the coil 200, and the eddy current coupling between the metal diaphragm and the coil reduces the inductance of the coil 200. On the contrary, when the fluid pressure decreases, the diaphragm 92 deforms in the direction away from the coil 200, so that the coupling of eddy currents decreases and the inductance of the coil increases. Therefore, the inductance of the coil 200 is inversely proportional to the pressure of the working fluid. When the inductance of the coil 200 changes, the resonance frequency of the LC circuit 206 changes.

FIG. 17 is a block diagram of the pressure measurement system of the fourth and fifth embodiments 180 and 196 of the present invention. In this system, the microprocessor 136 controls the induction coil circuit 208 and the induction coil 210. The microprocessor 136 changes the frequency of the induction coil 210 to magnetically couple the coil with the LC circuit 206 of the implanted portion 32, as indicated by line 212. The frequency at which the internal coil and the external coil are coupled varies depending on the resonance frequency of the implanted LC circuit 206. The resonant frequency of the implanted LC circuit varies with the fluid pressure in band 38. The change in resonance frequency is measured by the microprocessor 136 via the induction coil circuit 208. Once detected, the resonant frequency can be compared to a known pressure at a given frequency to determine the fluid pressure within band 28. The graphical user interface 140 of the external module 214 shows the measured fluid pressure on the display 66.

FIG. 18 is a graph showing a pressure signal 216 from the pressure sensing system of the present invention, as shown on display 66 upon user inquiry. In the example shown in FIG. 18, when the patient is at rest, the fluid pressure is initially measured by the pressure reader 60, resulting in a constant pressure measurement, as shown. Next, the band 38 is adjusted to reduce the size of the opening. During band adjustment, the pressure detection system continuously measures the fluid pressure and sends the pressure measurement to the pressure reader 60 through the patient's skin. As shown in the graph of FIG. 18, the pressure measurement is slightly elevated after band adjustment. In the example illustrated, the patient is asked to drink the liquid to check the accuracy of the adjustment. When the patient drinks the liquid, the pressure detection system continuously measures and displays the pressure spike due to the peristaltic pressure as the liquid is swallowed to the external module 36 for display. By measuring and displaying the load of the limiting device on gastric peristalsis both during and after the adjustment, the present invention provides the physician with an accurate and real-time visualized response to the adjustment. The instantaneous active display of this recorded pressure data allows the physician to make more accurate band adjustments. This data can be displayed for a period of time to provide a history of pressure over time.

In addition to being used during regulation, the pressure sensing system of the present invention can also be used to measure pressure fluctuations in limiting devices at various time intervals during treatment. By periodic pressure measurement, this pressure detection system can be used as a diagnostic tool to confirm whether the food intake restriction device is functioning effectively. Specifically, this pressure detection system can be used to detect a zero pressure state in a band that indicates fluid leakage. Alternatively, the system can be used to detect excessive pressure spikes in the band indicating twisting or obstruction within the opening of catheter 44.

In the pressure detection system of the present invention, the patient can also follow the patient's own treatment at home by using an external monitor such as an extracorporeal device 36. External devices can be used to routinely send pressure measurements to the physician's office to reduce the number of visits to the physician's office required to monitor the patient's treatment. In addition, the patient can take pressure measurements at home and notify the physician if the band pressure drops below or exceeds a particular baseline, suggesting the need for adjustment of the device. Therefore, the pressure sensing system of the present invention is useful as both a diagnostic tool and a monitoring tool when treating a patient with an obesity device.

Another alternative sensor system 1088, 1188 suitable for incorporation into port 42 is shown in FIGS. 19 and 20. Each of these pressure sensing systems 1088, 1118 includes an upper member 1092 and a housing 94. Similar to embodiments 88, 118, 170, 180, 196 of the pressure sensing system described above, the pressure sensing systems 1088, 1118 can be located below the holding cover 86 of port 42. Alternatively, the upper member 1092 can be integrated with the holding cover 86 so that it is the bottom of the holding cover 86 or reservoir 80. Other suitable structures will be apparent to those skilled in the art. In this example, the upper member 1092 communicates with the fluid received in the port 42, so that the pressure of this fluid is applied to the upper member 1092. Each of these pressure sensing systems 1088, 1118 also includes a microcontroller 106, a TET / telemetry coil 114, and a capacitor 116. Each of these pressure sensing systems 1088, 1118 can also include temperature sensors (not shown). The microcontroller 106, the TET / telemetry coil 114, and the capacitor 116 can be configured and function in the same manner as the structures and functions of these components 106, 114, 116 described above.

In the embodiment of the pressure sensing system 1088 shown in FIG. 19, a fluid access port 1094 is provided on the upper member 1092 and communicates with the pressure sensor 1120. The airtight seal 1122 secures the pressure sensor 1120 to the bottom of the upper member 1092. The pressure sensor 1120 is configured to detect the pressure of a fluid in the vicinity of the upper member 1092, which communicates with the pressure sensor 1120 via the fluid access port 1094. Since the pressure sensor 1120 is connected to the microcontroller 106, the pressure measurement obtained by the pressure sensor 1120 can be sent to the microcontroller 106 or to an external telemetry device via the microcontroller 106, thus the coil 114. Can be sent.

In the embodiment of the pressure detection system 1188 shown in FIG. 20, a pressure sensor 1180 having a can-like structure is arranged in the upper member 1092 and extends over the upper member 1092. The pressure sensor 1180 has a metal cap 1182 that acts as a diaphragm and is airtightly sealed. The pressure sensor 1180 and / or cap 1182 can be hermetically sealed and electrically insulated from adjacent conductive and / or electronic elements. Like the pressure sensor 1120, the pressure sensor 1180 is configured to detect the pressure of a fluid in close proximity to the upper member 1092. Similarly, since the pressure sensor 1180 is connected to the microcontroller 106, the pressure measurements obtained by the pressure sensor 1180 can be sent to the microcontroller 106 or external telemetry via the microcontroller 106 and the coil 114. Can be sent to the device. The pressure sensor 1180 may also contain silicon oil or gel to make the transmission of pressure from the cap 1182 more uniform, to enhance the electrical insulation of the pressure sensor 1180, or for other purposes. Alternatively, silicone oil or gel alternatives may be used or omitted.

FIG. 21 shows another exemplary port 1142. Port 1142 in this example includes an upper housing 1170 secured to a lower housing 1172. Port 1142 also includes bulkhead 76 and retainer 1176. The retainer 1176 is secured to the upper housing 1170 and is configured to hold the bulkhead 76. Port 1142 also includes a reservoir 80 and a catheter connector 82 that communicates fluidly with the reservoir 80. Plate 1178 is located at the bottom of the reservoir 80 and has multiple vents 90 that penetrate this plate 178. The pressure measuring chamber 1188 is located below the plate 1178 and has fluid communication to the reservoir 80 via the vent 90. A pressure sensor 1190 is located in the pressure measuring chamber 1188 and can measure the pressure of the fluid in port 1142.

In one embodiment, each pressure sensor 1120, 1180, 1190 includes a radio pressure sensor obtained from CardioMEMS, Inc. located in Atlanta, Georgia, but a suitable MEMS pressure sensor may be used for other suitable. It can also be obtained from the supplier. In one example, the MEMS pressure sensor 1190 includes a pressure sensor disclosed in US Pat. No. 6,855,115, which is incorporated herein by reference for purposes of illustration only. In this example, the pressure sensors 1120, 1180, 1190 are configured to wirelessly transmit pressure data to an external telemetry device. In another embodiment, each pressure sensor 1120, 1180, 1190 comprises a silicone dye. Of course, any other type of pressure sensor can also be used. Where necessary or desired, port 1142, shown in FIG. 21, includes, but is not limited to, any other component, including, but not limited to, TET / telemetry coils, capacitors, microcontrollers, and batteries (not shown). It can also be included. Other forms of modification will be apparent to those skilled in the art.

22 to 25 show an exemplary detection head 300 that operates to detect the position and orientation of ports 42, 1142 from the outside. The detection head 300 of this example includes a needle window 302, a series of horizontal coils 304, a series of vertical coils 306, a TET coil (not shown), and a cable 310. The TET coil is wound around a generally triangular bobbin (not shown), but any other structure can be used. In this example, the TET coil tunes in parallel with the low ESR capacitor at 50kHz to form a parallel tuning tank circuit. Since the coil 114 of the port 42 is tuned in series with the capacitor, the resonance impedance is minimized at the resonance frequency of 50 kHz. With an input power of 5W to the TET coil, the coil 114 can supply about 10mW of power. Of course, any other structure and parameters can be used.

Each vertical coil 306 of the detection head 300 is arranged vertically in the corresponding horizontal coil 304. Although three horizontal coils 304 and three vertical coils 306 are shown, it should be understood that any suitable number of coils 304, 306 can be used. In addition, it should be understood that the coils 304, 306 are shown in a generally triangular structure, but can be of any other suitable configuration or structure. The cable 310 is connected to the coils 304 and 306 and is also connected to the display device 350 as described in detail later. Of course, the detection head 300 can be connected to any other external device by wire, wirelessly, or otherwise.

The detection head 300 of this example is configured to communicate with an injection port, such as the injection port 42, as a mere example. The detection head 300 may communicate with any other injection port or device, including, but not limited to, alternative ports and variations thereof disclosed herein. However, it can be understood from reading this disclosure that, in certain embodiments, the type or amount of metal in the port can adversely affect the operation of the port and / or detection head 300. For example, such effects can be in the form of eddy currents in an undesired range. It should be understood that if the metal port housing causes undesired results, the coil 114 is placed outside such metal and is hermetically connected to the pressure sensor 87 or other port element. However, no such action is required for port 42 in this example.

In this example, the detection head 300 can power the port 42 via the TET coil. The detection head 300 can also detect the position and orientation of port 42, as described in detail below. Further, the detection head 300 can receive the pressure data and other data sent from the port 42 in a manner similar to the pressure reading device 60 described above. Communication related to position, orientation, and pressure will be discussed in more detail below, but one of ordinary skill in the art would provide any other type of information between port 42 and detection head 300 in any other suitable manner. Let's understand that you can communicate with.

In one use, the detection head 300 is located in the vicinity of patient 34 in an area approximately close to port 42. As will be described in detail later, the detection head 300 can be used to determine the position and orientation of the port 42 so that the user can place the detection head 300 directly above or sufficiently close to the port 42. Once the detection head 300 is arranged in this way, the user can insert the needle 430 of the syringe 400 through the needle guide 302 of the detection head 300 to reach the septum 76 of the port 42 in one go. it can. The user can then use the syringe 400 to regulate the pressure of the fluid in the implant 32.

With the detection head 300 initially located, the horizontal coil 304 is configured to detect the RF signal generated by the coil 114 in the port 42. It should be understood that the characteristics of such RF signals can vary depending on the position of the detection head 300 with respect to port 42. The display device 350 can receive such an RF signal display from each horizontal coil 304 and can process these signals by logic capable of comparing the signals taken out by each horizontal coil 304. .. Therefore, the detection head 300 can be used to determine the position of port 42 by triangulation. For example, if the detection head 300 is located directly above port 42, the three received signals will have approximately equal amplitude and almost zero phase shift. However, it is not possible to arrange the detection head 300 so that the RF signals detected by each horizontal coil 304 have the same amplitude and the phase shift with respect to the RF signals detected by the other horizontal coils 304 is zero. Please understand that it will be possible. Therefore, the detection head 300 can be moved in the vicinity of the patient 34 until the difference in amplitude and phase of the RF signal detected by the horizontal coil 304 is minimized.

As will be described in more detail below, the display device 350 provides the user with a visual representation of the relative positions of the detection head 300 and port 42, and identifies the detection head 300 as directly above port 42. It can also include logic that can display.

The detection head 300 can also include a function capable of visually displaying position information. In this example, the detection head 300 includes a plurality of LEDs 312 arranged in a "plus sign" -like configuration. The LED 312 can indicate to the user the relative position of the detection head 300 and the port 42. Specifically, the lit LED 312 can indicate the position of port 42 with respect to the detection head 300. For example, if the detection head 300 needs to be moved downwards and to the right in order to place it directly above port 42, the rightmost and bottom LED 312s can be lit. When the detection head 300 moves so that it is directly above the port 42, the LED stays close to the detection head 300 until the center LED 312 lights up and the detection head 300 is almost directly above the port 42. It is possible to provide feedback indicating the degree. When the central LED 312 is lit, the user can further adjust the position of the detection head 300 by checking the display device 350, which will be described in detail later. When using the LED312, such an LED312 can be placed in any suitable structure other than the "plus sign". Such alternative structures can include Cartesian, polar, numeric, or any other kind of representation. As a mere example, a star-shaped or compass rose structure can also be used. In another embodiment, an array of LED 312s is provided that can be selectively lit in the form of directional arrows. The length of such arrows can vary to indicate distance. It should be understood that additional LED312s can be used to increase the spatial resolution of distances and / or directions indicated by such LED312s. Of course, any suitable alternative LED 312 can be used, including but not limited to LCD screens or other displays.

In one embodiment, logic is provided within the detection head 300 that is configured to process the signal received by the horizontal coil 304 and feed back the position by the LED 312. In another embodiment, such logic is provided within the display device 350 and partially communicates with the LED 312 via cable 310. In yet another embodiment, logic for driving the LED 312 is provided on both the detection head 300 and the display device 350. Other suitable positions of logic for driving the LED312 and other methods of driving the LED312 will also be apparent to those skilled in the art. It should be understood that the LED 312, like any other element and structure disclosed herein, can simply be omitted.

With the detection head 300 initially located in the vicinity of patient 34 in a region approximately close to port 42, vertical coil 306 will now detect the RF signal generated by coil 114 in port 42. It is configured. It should be understood that the characteristics of such RF signals can vary depending on the orientation of the detection head 300 with respect to port 42 (eg, pitch, yaw, roll, attitude, etc.). The display device 350 can receive a display of such RF signals from each vertical coil 306 and can process these signals by logic that can be compared to the signal retrieved by each vertical coil 306. it can. If the detection head 300 is placed parallel to port 42, the three received signals will have approximately equal amplitude and almost zero phase shift. As will be described in more detail below, the display device 350 represents the relative orientation of the detection head 300 and the port 42, and tells the user when the detection head 300 is oriented substantially parallel to the port 42. It can also include logic that can be displayed.

In another embodiment, the detection head 300 and the port 42 have orientation characteristics between signals radiated by the coil 114 in the detection head 300 (eg, launch / drive signals from the TET coil in the detection head 300). It is configured so that it can be detected based on the phase relationship of. For example, if the signals are in phase, such a relationship suggests that the port 42 is oriented parallel to the detection head 300 and the bulkhead 76 faces the detection head 300, and the signal is out of phase. A 90 degree shift indicates that port 42 is perpendicular to the detection head 300, and a signal phase shift of 180 degrees indicates that port 42 is inverted relative to the detection head 300. It can be suggested (eg, the bulkhead 76 faces inward towards the center of patient 34). Other orientations can also be detected based on the corresponding phase relationship. Alternatively, the coil 114 in the port 42 can emit a constant pattern of pulses as the detection head 300 passes over the port 42. For example, if the front side of port 42 is on the top, the pattern is two short pulses followed by a long pulse (eg, about 3% to 4% longer than the short pulse), with port 42 flipped 180 degrees on the back side. If is above, the pattern can be reversed. The detection head 300 receives such a signal, and the detection head 300 or any other device (such as the display device 350) processes such a signal to produce sound or visual related to the orientation of port 42. Information can be given to the user. Therefore, it should be understood that the vertical coil 306 is not always necessary to obtain orientation information. Other suitable structures and techniques for determining orientation information will also be apparent to those of skill in the art.

An alternative detection head 301 is shown in FIG. In this modified form, the needle window 303 is deviated from the center of the detection head 301, but other than that, it is configured in the same manner as the detection head 300. Such displacement of the needle window 303 can alleviate the physical obstruction of the housing of the detection head 301 by the anatomical structure of the patient 34's outer surface. If the stylus window 303 is not off-center, such physical interference creates difficulty in arranging the stylus window 302 at the center of the detection head 300 over the port 42. It is understood that the displacement of the needle window 303 shown in FIG. 26 is merely an example and the needle window 303 can be in other positions (eg, near the edges or corners of the housing of the detection head 301). I want to. It should be understood that if the needle window 303 is not centered on the detection head 301, then the needle window 303 is not located entirely in the center of the structure of the horizontal and vertical coils 306. Nevertheless, the coils 304 and 306 can be used to determine the relative position of the needle window 303 and the port 42 using a technique similar to that used in the detection head 300. For example, correction constants (eg, vectors) can be included in the elements of the algorithm used to process the RF signals detected by coils 304, 306. Such a correction constant can represent the displacement (eg, with respect to distance and direction) of the needle window 303 with respect to the center of the detection head 301 (or the center of the structure of the coils 304, 306). Those skilled in the art will appreciate various ways in which such modification constants can be included in the elements of the algorithm.

As a mere example, the position of the center of the detection head 301 with respect to port 42 can be initially determined by comparing the RF signals received by the horizontal coil 304 (eg, for phase and amplitude) (hence the "determined position"). can get). Next, a correction constant is added to this determination position to determine the position of the needle window 303 with respect to the port 42. Alternatively, the characteristics of the RF signal received by the coil 304 will be one or more characteristic mismatches (or a range of one or more characteristic mismatches) if the needle window 303 is located directly above port 42. The algorithm can address this discrepancy in a manner similar to the phase and amplitude difference of the minimized RF signal received by the coil 304 in the detection head 300. In other words, this algorithm can address such discrepancies as a goal to be reached. When the needle window 303 is located directly above the port 42, the characteristic mismatch in the nature of the RF signal detected by the horizontal coil 304 can be a function of the displacement of the needle window 303 with respect to the detection head 301. Therefore, the mismatch of characteristics can be determined in advance. Of course, any other technique or structure suitable for determining the position of the needle window 303 with respect to the port 42 can also be used.

FIG. 27 shows an exemplary display device 350 that is configured to transform the information transmitted by the detection head 300 into a visual representation that can be read by the user. In this example, the display device 350 is connected to the detection head 300 via cable 310, but any alternative to cable 310 can be used. The display device 350 further includes a graphic display 354 including the aiming display 360 illustrated in FIGS. 28 and 29. The aiming display 360 of this example includes a cross shape 362 and an arrow display 364. The aiming display 360 of this example can provide position and orientation information about the position and orientation of the detection head 300 with respect to port 42. Specifically, the position of the tip 366 of the arrow display 366 with respect to the center 364 of the cross 362 can serve to indicate the position of the needle window 302 with respect to the center of the port 42 (eg, partition wall 76). In other words, the center 364 of the cross 360 can represent the center of the bulkhead 76, and the tip 366 of the arrow display 366 can represent the needle window 302. The alignment data can be updated at any appropriate interval, such as near real time, and the position can be fed back to the user using the aiming display 360. Therefore, the user can move the detection head 300 until the aiming display 360 indicates that the needle window 302 is located directly above the port 42.

Orientation data for the tilt of the arrow display 366 can be displayed using the aiming display 360. In other words, the direction and degree of tilt of the arrow display 366 can represent the orientation of the detection head 300 with respect to the port 42, so that the arrow display 366 swivels around its tip 366 to indicate such orientation. To do. Like the alignment / positioning data, the orientation data can be refreshed at any suitable interval, such as near real time, and the orientation can be fed back to the user using the aiming display 360. If the detection head 300 is unsatisfactory with respect to port 42 (eg, port 42 is flipped back, i.e. on the patient's fascial plane), the surgeon turns port 42 again. It will be necessary.

FIG. 29 is a view of display device 350, where the aiming display 360 shows that the detection head 300 is substantially above port 42 and is substantially parallel to port 42. Therefore, since the arrow display 366 is located above the center 364 of the cross shape 362 and is in a vertical swivel position (ie, perpendicular to the screen), only the tail 370 of the arrow display 366 is shown. Such a display can indicate to the user that the needle 403 inserted straight into the needle window 302 has reliably reached the bulkhead 76 of the port.

It should be understood that another visual display can be given to the user, such as by using color to indicate position and orientation information. For example, in the aiming display 360 shown in FIG. 28, the arrow display 366 indicates that the needle 403 is not properly inserted into the needle window 302 (for example, the needle 403 has not reached the partition wall 76). Therefore, it can be shown in red. In contrast, in the aiming display 360 shown in FIG. 23, it is appropriate to insert the tail 370 of the arrow display 366 into the needle window 302 (eg, the needle reaches the bulkhead 76). Can be shown in green to indicate that.

It should be understood that the detection head 300 does not have to be perfectly parallel to the port 42 when the needle 403 is properly inserted into the bulkhead 76 through the needle window 302. Therefore, the display device 350 should provide an indication that the needle 403 is properly reachable to the bulkhead 76 through the needle window 302, even if the detection head 300 is oriented non-parallel to the port 42. Can be done. For example, such non-parallel orientations can indicate that the tail 370 of the arrow indicator 366 is within a particular ring of the cross-shaped 362. Alternatively, such an orientation can be indicated by a colored arrow display that is yellow or another color. One of ordinary skill in the art will appreciate another way in which the sufficiency of non-parallel orientation can be shown on the aiming display 360.

Similarly, even if the detection head 300 is not sufficiently oriented with respect to the port 42, the detection head 300 may not be placed directly above the port 42, but the detection head 300 is not placed directly above the port 42. However, it may be possible to point the detection head 300 approximately parallel to port 42. In such a case, if the needle 403 is properly oriented with respect to the detection head 300 (eg, an angle of about 80 degrees or a displacement of 10 degrees), the needle 403 is inserted into the bulkhead 76 through the needle window 302. be able to. Therefore, the display device 350 can provide a display indicating that the needle 403 can properly reach the partition wall 76 through the needle window 302 even if the detection head 300 is not located directly above the port 42. For example, such an orientation can indicate that the tail 370 of the arrow indicator 366 is within a particular ring of the cross shape 362. Alternatively, such an orientation can be displayed by coloring the arrow display 366, such as in yellow or another color. Other methods of being able to show the adequacy of the position of the indirect detection head 300 on the aiming display 360 will be apparent to those skilled in the art.

It should be understood that the detection head 300 can be configured to obtain depth data indicating the distance from the needle window 302 to the port 42 (and thus the depth to the bulkhead 76). Such depth data can be displayed on the display device 350 in various ways. For example, this depth can be displayed numerically and / or in various other ways. In addition to information related to position, orientation, and depth, other geometry information that can be detected by the detection head 300 and transmitted to the display device 350 will be apparent to those skilled in the art.

In addition to displaying information related to the position and orientation of the detection head 300 relative to the port 42, the display device 360 can also display pressure data sent from the port 42 to the detection head 300. Therefore, the display device 350 of this example includes a pressure display portion 374. As shown, the pressure display portion 374 shows an initial pressure measurement, a baseline pressure measurement, and a peak pressure measurement. The initial pressure measurement represents the pressure in the implant 32 before the fluid is added or withdrawn. The baseline pressure measurement represents the current pressure within the implantation site 32 (for example, when fluid is added or removed, or after fluid is added or removed). The peak pressure measurement value represents the peak pressure detected during the peristaltic movement of the stomach. Of course, parameters can be displayed from other pressures as other data such as temperature.

As described above, the detection head 300 can be configured to receive pressure data from the port 42 in the same manner as the pressure measuring device 60. Therefore, it should be understood that the TET coil of the detection head 300 can act as a telemetry coil that receives a telemetry signal from coil 114 in port 42 that indicates pressure or other data. Alternatively, another coil dedicated to such telemetry can be provided in the detection head 300. As yet another modification, either the vertical coil 306 and / or the horizontal coil 304 can be used for such telemetry. Still other suitable configurations will be apparent to those skilled in the art.

From the above, it is understood that the detection head 300 and the display device 350 can be used to display pressure measurements to the user in near real time before, during, and after fluid addition or withdrawal to the implant 32. I want to be. For example, the surgeon adjusts the saline solution in the implant 32 while the patient 34 swallows a certain amount of water, at which time the detection head 300 and the display device 350 monitor the pressure level in the implant. Can be done. It should be understood that optimal pressure regulation can be determined based on various factors associated with pressure data. Examples of such various factors include, but are not limited to, the original baseline pressure, the new baseline pressure, the maximum peristaltic pressure, the minimum peristaltic pressure, the length of the peristaltic contraction, the Fourier transform of the peristaltic contraction data spike, Added by the pressure decay time constant during peristaltic contraction, the total average pressure decay time constant when swallowing water, the number of peristaltic contractions to swallow a given amount of water, the implanted device and / or anatomical structure. One or more forces, the energy of the fluid in or within the implanted device, the rate of infusion of fluid into the implanted device, the amount of fluid in the implanted device, the acceptance of the implanted device Capability, fluid flow velocity into the implanted device or fluid flow velocity within the implanted device, fluid pressure pulse rate within the implanted device, fluid within the implanted device Count of pressure pulses, one or more electrical signals sent by the tissue prior to adjustment of the implanted device and / or one or more electrical signals sent by the tissue in response to this adjustment, implanted The chemical action by the tissue prior to the regulation of the device and / or the chemical action by the tissue in response to this regulation, the feedback of other tissues in response to the regulation of the implanted device, or any other factor can be mentioned. ..

In one embodiment, the display device 350 operates to receive data (eg, from a sensor, etc.) indicating the factors described above in any suitable manner, and automatically processes such factors. The processing result can be shown to the user. For example, the display device 350 determines the ideal amount of fluid to be added or removed based on the processing of such factors, and sends a message such as "add 4 cc of fluid" or "extract 0.5 cc of fluid". It can be configured so that it can be simply displayed to the user. Such messages can be displayed in place of or in addition to displays such as pressure measurements or pressure fluctuations. Those skilled in the art will also be aware of any of the factors mentioned above or other suitable treatments of other factors, and methods of presenting the results of such treatments to the user.

In this example, the pressure sensor 84 supplies pressure data at an update rate of about 20 Hz. Such rates can complete the telemetry / TET mode cycle approximately every 50 milliseconds. For example, the coil 114 powers port 42 in TET mode for about 45 ms and then supplies pressure data in telemetry mode for about 5 ms. Of course, any other switching technique can also be used. It should be understood that switching between TET and telemetry may not always be necessary. For example, port 42 can be activated so that TET is not needed. As another example, a second coil (not shown) is added to port 42, with one coil in port 42 dedicated to TET and the other dedicated to telemetry. Other alternative embodiments and modifications will be apparent to those of skill in the art.

Although the display device 350 in this example shows the pressure data numerically, it should be understood that the pressure data can be shown in various other ways. For example, in a graph, pressure can be shown as a function of time. Such graphs may be useful for pressure monitoring or other purposes during peristalsis. It should be understood that the absolute value of the pressure at a particular moment in time does not need to be displayed and the display device 350 can instead display the fluctuation of the pressure value. Other methods of displaying pressure data or other data will also be apparent to those of skill in the art.

As mentioned above, given the pressure measurements within the implant 32, it may be desirable to consider temperature, ambient pressure, and other factors. Therefore, the detection head 300 can receive additional data such as temperature measurements obtained within the implant 32, and the display device 350 is configured to adjust the pressure measurements according to various such factors. Can include logic.

In one form, the detection head 300 includes a switch (not shown) that switches the detection head 300 between the alignment mode and the pressure detection mode. Therefore, the user can put the detection head 300 in the alignment mode, obtain the position and orientation data, and properly position the detection head 300 on the port 42. The user can then switch the detection head 300 to pressure detection mode to obtain pressure measurements before, during, and after fluid addition or withdrawal from the implant 32. Alternatively, a similar switch can be provided on the display device 350. In yet another embodiment, the detection head 300 can be used simultaneously in alignment mode and pressure detection mode without the use of any switches. Those skilled in the art will also be aware of yet another possible mode and the structure for switching between such modes.

It should be understood that the detection head 300 can be used for ports that have a coil but no pressure sensor. In other words, the detection head 300 can be used to simply determine the position and orientation of the port. In making such a decision, pressure data may or may not be obtained from a source other than the port (eg, from a sensor other than the implant, or from a sensor outside the patient's body). .. In addition, although in the above example the detection head 300 with port 42 is used, it should also be understood that the detection head 300 can be used with port 1142. Of course, such use would require other equipment capable of including the TET / telemetry coil within the detection head 1142 or transmitting signals to the coils 304, 306. Other forms of detection head 300 and other forms of use of the detection head 300 will be apparent to those skilled in the art.

Another embodiment is shown in FIGS. 30 and 31 showing an exemplary syringe 400 and display device 420 connected by cable 422. The syringe 400 includes a plunger 402, a barrel 404, a pressure sensing element 410, and a needle 430. In this example, the plunger 402, barrel 404, and needle 430 are conventional parts. Thus, the barrel 404 has a male luer lock portion 406 and the needle 430 has a female luer lock portion 424. The plunger 402 has a piston 408 configured to engage the barrel 404 in a hermetically sealed manner. In one form, the needle 430 includes a Huber needle. Of course, in particular, any of these factors can be changed.

Cable 422 has a boot portion 429 configured to be selectively attached to the pressure sensing element 410. The boot portion 429 also includes a functional structure (not shown) that is electrically connected to the pressure sensor 426 and can transmit the pressure measurement value measured by the pressure sensor 426 via the cable 422. Such a functional structure can also include one or more terminals (not shown) or any other structure. In another embodiment, the pressure sensing element 410 is secured to the boot portion 429 and the cable 422. Other suitable structures will be apparent to those skilled in the art.

In this example, the pressure sensing element 410 includes a male luer lock portion 412, a female luer lock portion 414, a vertical cylindrical portion 416, a horizontal cylindrical portion 418, and a pressure sensor 426. The male luer lock portion 412 of the pressure sensing element 410 is configured to engage the female luer lock portion 424 of the needle 430, and the female luer lock portion 414 of the pressure sensing element 410 is the male of the barrel 404. It is configured to engage the mold luer lock portion 406. Therefore, it should be understood that the pressure sensing element 410 can be retrofitted to a variety of existing syringes. Alternatively, the syringe 400 can be configured to have a pressure sensing element 410 or can integrally form a similar functional structure.

As shown, the pressure sensor 426 is located in the horizontal cylindrical portion 418 in close proximity to the annular flange 428. In one example, the pressure sensor 426 is hermetically secured to the annular flange 428. In this example, the boot portion 429 has one or more electrodes (not shown) or similar functional structures configured to communicate with the pressure sensor 426 when the boot portion 429 engages the pressure sensing element 410. Including. In another example, the pressure sensor 426 is secured within the boot portion 429 and when the boot portion 429 engages the pressure sensing portion 410, it can approach the annular flange 428. Alternatively, any other suitable structure can be used.

The pressure sensor 426 can be configured according to any of the pressure sensors described above. Alternatively, the pressure sensor 426 can include any pressure sensor in stock suitable for use, or any other type of pressure sensor. In this example, when the syringe 400 is assembled, the vertical cylindrical portion 416 defines a closed conduit with fluid communication from the barrel 404 to the needle 430. The vertical cylindrical portion 416 communicates fluidly with the horizontal cylindrical portion 418 as well as the pressure sensor 426. Therefore, it should be understood that the pressure sensor 426 can operate to detect the pressure of the fluid in the syringe 400. It should be understood that the pressure detected by the pressure sensor 426 can be transmitted to the display device 420 via the cable 422 and displayed on the display device 420 in any suitable format.

In one use, the needle 430 is inserted into patient 34 to reach the septum of the injection port (not shown). Any suitable port may be used, including, but not limited to, any of the ports 42, 1142 described above, these modifications, and any port without a pressure sensor. In this example, during such insertion, the needle 430 communicates fluidly with the implant portion 32 so that the pressure of the fluid in the implant portion 32 and the pressure of the fluid in the syringe 400 can be substantially equal. Therefore, it should be understood that the pressure detected by the pressure sensor 426 can indicate the pressure of the fluid in the implant 32. Such pressure information would be particularly useful in adjusting the pressure within the implantation site 32 by adding or removing fluid to or from the implantation site 32 with the syringe 400. Specifically, the syringe 400 allows the fluid pressure to be adjusted and read simultaneously.

For example, the user first inserts the needle 430 into patient 34 to reach the septum 76 of injection ports 42, 1142. Once the pressures are equal, the user can see the initial pressure on the display device 420. It should be understood that pressure equilibrium can be determined by keeping the pressure readings substantially constant. The user can then add or remove fluid to the implant portion 32 with the syringe 400 while checking the change in pressure displayed on the display device 420. Such pressure measurements when the user adds or withdraws fluid to the implant 32, as no valve or other mechanism is required to switch between the pressure detection mode and the add / remove mode of the syringe 400. Can be obtained. Therefore, the pressure sensing element 410 and the pressure sensor 426 can be considered to be substantially in series with the elements of the other syringe 400. As used herein, "substantially in series" means that when pressure is detected by the pressure sensor 426, fluid can be added or removed by the syringe 400 at substantially the same time, and the addition / removal mode of the syringe 400 and the syringe 400 are used. This means that there is no need to operate a valve or other mechanism to switch the pressure detection mode of. However, the term "substantially in series" should not be construed as requiring that a straight line be orthogonal to all other components of the pressure sensor 426 and syringe 400.

Therefore, when the user adjusts the pressure with the syringe 400, the pressure measurement value can be obtained in almost real time. If there is a delay between the operation of the user's syringe 400 and the time at which the fluid pressure between the syringe 400 and the implant portion 32 is in equilibrium, the user is inspected by the pressure measurement shown on display device 420. You may simply wait until the value is substantially constant. Other suitable uses of the syringe 400 and display device 420 will also be apparent to those skilled in the art.

FIG. 32 shows an exemplary alternative to cable 422. In this modification, the wireless infrared communication device 440 is used instead of the cable 422 form of the syringe 400 shown in FIGS. 30 and 31. The infrared communication device 440 includes a pair of LEDs 442, a battery 444, and a pull tab 446. The infrared communication device 440 can be fixed to the pressure detection element 410 and is connected to the pressure sensor 426. In one embodiment, the pressure sensor 426 is received within the infrared communication device 440 and, when coupled to the pressure sensing element 410, is configured to be exposed to the pressure of the fluid within the pressure sensing element 410. There is. For example, such pressure exposure can be achieved by making the pressure sensor 426 come into direct contact with the fluid in the pressure sensing element 410. Alternatively, the infrared communicator 440 and / or the pressure sensing element 410 is a diaphragm or other that is located between the pressure sensor 426 and the fluid in the pressure sensing element 410 and is capable of transmitting pressure to the pressure sensor 426. Members can be included. In yet another embodiment, the pressure sensor 426 is a component of the pressure sensing element 410, so that the infrared communicator 440 receives the pressure data obtained from the pressure sensor 426 when coupled to the pressure sensing element 410. It is configured. Yet another suitable configuration will be apparent to those skilled in the art.

The infrared communication device 440 of this example can transmit the pressure data obtained from the pressure sensor 426 by infrared light by the LED 442. Therefore, it should be understood that the display device 420 can be modified to include an infrared sensor (not shown) capable of receiving such transmissions. The battery 444 can be used to power the infrared communication device 440. Prior to initial use, a pull tab 446 can be initially placed between the battery 444 and the terminals to preserve the life of the battery 444. Therefore, the user can remove the pull tab 446 before using it for the first time. Alternatively, the infrared communication device 440 may include a switch or other mechanism for selectively operating the battery 444. Other forms of modification will be apparent to those skilled in the art. It should also be understood that this modification of the syringe 400 can be used in the same manner as any other modification of the syringe 400 described above.

FIG. 33 shows yet another exemplary alternative to cable 422. In this modification, a radio frequency (RF) communication device 450 is used instead of the cable 422 form of the syringe 400 shown in FIGS. 30 and 31. The RF communication device 450 includes an RF coil 452, a battery 444, and a pull tab 446. The RF communication device 450 can be fixed to the pressure detection element 410 and is connected to the pressure sensor 426. As described above using the infrared communication device 440, the pressure sensor 426 can be placed in the RF communication device 450 or in the pressure detection element 410. Other suitable structures will be apparent to those skilled in the art.

The RF communication device 450 of this example can transmit the pressure data obtained from the pressure sensor 426 as an RF signal by the RF coil 452. Therefore, it should be understood that the display device 420 can be modified to include an RF signal receiver (not shown) capable of receiving such transmissions. The battery 444 can be used to power the RF communication device 45. The pull tab 446 can be initially placed between the terminal and the battery 444 to preserve the life of the battery 444 prior to its first use. Therefore, the user can remove the pull tab 446 before the first use. Alternatively, the RF communication device 450 may include a switch or other mechanism for selectively operating the battery 444. Other forms will be apparent to those skilled in the art. It should be understood that this modification of the syringe 400 can be used in the same manner as any other modification of the syringe 400 described above.

FIG. 34 shows another exemplary pressure sensing syringe system 1400. In this example, the syringe system 1400 includes a syringe 400, a tube 1402, a pressure sensing portion 1420, a cable 1404, an interface element 1406, and a display device 1408. Syringe 400 includes a T-joint 1410 with a two-way luer valve 1412. The T-joint 1410 has fluid communication with the needle 430 and tube 1402. The two-way luer valve 1412 is configured to open when the T-joint 1410 is coupled to the male luer lock portion 406 of the syringe 400. Of course, the T-joint 1410 or other device can also be placed without the two-way luer valve 1412. It should be understood that the pressure sensing element 1410 described above may also have a two-way luer valve (eg, female luer lock portion 414). In this example, when the T-joint 1410 is coupled to the syringe 400, the tube 1402 can transfer the pressure of the fluid in the syringe 400 to the pressure sensing portion 1420. It should be understood that T-fittings can be attached to various existing syringes 400 and needles 430. When using a two-way luer valve 1412 or similar device (eg, in a T-joint 1410 or in a pressure sensing element 410), avoid affecting the downstream elements of the two-way luer valve 1412 with fluid pressure. The barrel 404 can be removed after adjusting the pressure. In just one example, it would be desirable to use a syringe 400 to regulate the pressure, then remove the barrel 404 from the two-way luer valve 1412, allow patient 34 to stand upright, and then obtain pressure measurements. Removal of the barrel 404 and / or other use of the two-way luer valve 1412 may also be desirable in a variety of other situations.

As shown in FIGS. 34-36, the pressure sensing portion 1420 includes a reusable sensor portion 1422 and a disposable cap portion 1424. The reusable sensor portion 1422 and the disposable cap portion 1424 are configured to selectively engage with each other. When coupled to the reusable sensor portion 1422, the disposable cap portion 1424 communicates fluidly with the reusable sensor portion 1422 so that the pressure of the fluid in the tube 1402 is reused through the disposable cap portion 1424. It can be transmitted to a possible sensor portion 1422. In one embodiment, the disposable cap portion 1424 is incorporated herein by reference in US Pat. No. 6,725, Includes the pressure dome disclosed in No. 726. The reusable sensor portion 1422 includes a pressure port 1426 configured to receive such fluid pressure transmission transmitted from the disposable cap portion 1424. For example, pressure port 1426 can include a diaphragm or other structure suitable for receiving fluid pressure transmission. The reusable sensor portion 1422 also includes a pressure sensor (not shown) such as a transducer configured to supply pressure data to interface element 1406 via cable 1404. Interface element 1406 can process such pressure data and send it to display device 1408 via cable 1404. In one embodiment, the reusable sensor portion 1422 includes a model SP840 or SP844 sensor sold by MEMSCAP, located in Durham, NC, but elements of any other sensor portion 1422 can also be used. Of course, the interface element 1406 and the display device 1408 can be optionally integrated into one device. Interface elements 1406 and / or display device 1408 can include desktop PCs, laptop computers, personal digital assistants (PDAs), dedicated devices, or any other suitable device.

It should be understood that it is desirable to introduce the fluid into the tube 1402 in order to effectively transfer the pressure of the fluid in the syringe 400 to the reusable sensor portion 1422. Such a fluid can be introduced into tube 1402 before making a pressure measurement. The fluid in tube 1402 can be the same type of fluid as the fluid in syringe 400 (eg, saline), but is not limited to any, including, but not limited to, gel, silicone fluid, saline, and the like. Fluid can also be used. In one embodiment, the tube 1402 is prepared by introducing a fluid into the tube 1402 prior to use (eg, before connecting the T-joint 1414 to the syringe 400). In another embodiment, the tube 1402 is initially empty and free of fluid, and the user introduces the fluid into the tube 1402 before using the syringe 400 to flush the fluid to injection ports 42, 1142. Can be added or removed. Therefore, the vent cap 1414 can be provided on the disposable cap portion 1424 to facilitate the exhaust of air from the tube 1402 and facilitate the introduction of fluid into the tube 1402.

As mentioned above, the user can adjust the gastric band 38 by adding or removing fluid to ports 42, 1142 using the syringe 400. Adjust the pressure of the gastric band 38 when using the pressure-sensing syringe system 1400 assembled as shown in FIG. 34 in this way, or when any suitable modification of the pressure-sensing syringe system 1400 is used. It should be understood that the fluid pressure can be detected and the pressure measurement value can be obtained. In other words, pressure detection and regulation can be performed substantially simultaneously without operating a stopcock valve or similar device to switch between pressure regulation alone and pressure detection alone. Alternatively, such a stopcock valve or similar device can be provided.

The reusable sensor portion 1422 and the disposable cap portion 1424 are shown as separate elements, but it is believed that these elements 1422, 1424 can be used alone as an alternative. Yet another variation will be apparent to those skilled in the art.

FIG. 37 shows a modified form of the syringe 400. In this modification, the pressure sensor 426 is located between the plunger 402 and the piston 408 and is connected to the display device 420 via a cable 422. Alternatively, the pressure sensor 426 can be placed within the piston 408 or at the distal end of the piston 408 so as to contact the fluid within the barrel 404. In any of these modifications, the pressure sensor 426 is configured to detect the pressure of the fluid in the barrel 404, so that when the needle 430 is placed in fluid communication with the implant portion 32, the implant portion The pressure of the fluid in 32 can be detected. Similar to the embodiment described above, such pressure measurements are displayed to the user by the display device 420 in near real time as the user adds or withdraws fluid to the implantation site 32 using the syringe 400. can do.

The above description only describes the proper location of only a few cases of patient 34's external pressure sensor. Within the barrel 404 (eg, close to the male luer lock portion 406), within the needle 430 (eg, close to the female luer lock portion 424), or any other suitable, but not limited to. There are several other suitable positions, including the position. Similarly, although only the modified form of the syringe 400 is shown, the modified form of the display device 420 is also possible. For example, the display device 420 in this example is dedicated to the pressure sensor 426, but the display device 420 can be any other device. As a mere example, the display device 350 shown in FIG. 27 can be configured to receive communication from the pressure sensor 426. Alternatively, the pressure sensor 426 can be configured to communicate with a desktop PC, laptop computer, personal digital assistant (PDA), or any other device. Other modifications of the syringe 400 and display device 420, as well as the method of processing pressure data, will be apparent to those skilled in the art. In just one example, the display device 420 or any other device analyzes the pressure amplitude, pressure volatility, and / or other factors, and the syringe 400 you are using is too long or too small. Determine if it is too or inappropriate (eg, the injection rate is too fast) and warn the user if such a condition exists (eg, visually and / or It can be configured to emit (acoustic).

An embodiment of the detection head 300 (described above with reference to FIGS. 22-26) can receive pressure-related communications from ports 42, 1142 having pressure sensors 84, 1190, but those skilled in the art will appreciate it. It will be appreciated that the detection head 300 or a modification thereof can be used with any modification of the syringe 400 (described above with reference to FIGS. 30-37). For example, the detection head 300 is used to determine the position and orientation of ports 42, 1142 within the patient 34, and after appropriate alignment of the detection head 300 based on such position and orientation determination, any of the above. The needle 430 of the syringe 400 can be inserted through the needle window 302. Pressure data can be obtained from pressure sensors 84 in ports 42, 1142 and / or extracorporeal pressure sensors 426 in patient 34. Other suitable combinations of the above components will also be apparent to those of skill in the art.

The embodiments described above include using the pressure sensor in ports 42, 1142, in syringe 400, or elsewhere outside the patient 34, but the pressure sensor is located elsewhere in the patient 34's body. Please understand what you can do. For example, as shown in FIG. 38, the pressure sensor 500 can be placed within the gastric band 502. For example, the pressure sensor 500 can be placed within the inflatable portion of the gastric band 502. When the stomach band 502 includes an elastic portion and an inelastic portion, the pressure sensor 500 may or may not be fixed to either the elastic portion or the inelastic portion. In each case, the pressure sensor 500 detects the pressure of the fluid in the gastric band 502 before, during, and after the fluid is added or withdrawn from the gastric band 502 via the infusion port 2042 and the catheter 44. Can be sent. It should be appreciated that the pressure sensor 500 can be used to regulate the pressure in the gastric band 502 using a pump (not shown) or any other device.

Alternatively, as shown in FIG. 39, the pressure sensor 504 fluidizes in the catheter 506, in the pump, in the reservoir, or in the catheter 506 located between the gastric band 508 and the port 2042. Can be placed in the device of. As another modification, an example of which is shown in FIG. 40, the pressure sensor 1504 can be anchored in series with the catheter 506 and is not located within the catheter 506. In yet another modification, the example shown in FIG. 41, the sensor housing 2504 can be removably connected to the catheter 506. In this example, the pressure sensor 504 is located within the sensor housing 2504, which has a pair of detent connectors 2506 configured to engage the ends of the catheter 506. Therefore, the sensor housing 2504 is configured to define a fluid tube between the port 2042 and the gastric band 508 so that the pressure of the fluid in the sensor housing 2504 can be detected. It should be understood that an already implanted catheter 506 can be retrofitted to the sensor housing 2504 by simply cutting the catheter 506 and inserting a detent connector 2506 into the cut end. It should be understood that any alternative to the detent connector 2506 can be used, including, but not limited to, clamps, clips, adhesives, or welds.

Yet another embodiment is shown in FIG. 42 showing a catheter 506 with a T-shaped intersection 550. The pressure sensor 504 is provided in the arm of the T-shaped intersection 550 perpendicular to the catheter 506 and communicates with the catheter 506 in fluid communication. In one embodiment, the T-shaped intersection 550 is integrally formed with the catheter 506. In another embodiment, the T-shaped intersection 550 is a separate element that is attached to the catheter 506 (eg, using a structure similar to the detent connector 2506). Other suitable methods capable of providing the T-shaped intersection 550 will be apparent to those skilled in the art. Similarly, other methods by which the pressure sensors 504, 1504 can be placed within the catheter 506, in series with the catheter 506, or in close proximity to the catheter 56 will be apparent to those skilled in the art.

Alternatively, the pressure sensor 510 can be placed within the buckle 512 of the gastric band 514, as shown in FIG. In yet another embodiment (not shown), a pressure sensor is placed at the boundary between the infusion port and the catheter and / or the boundary between the gastric band and the catheter. Other suitable locations for the pressure sensor will also be apparent to those skilled in the art, including, but not limited to, any location within or near the flow path of the gastric band system. In addition, pressure sensors 500, 504, 510, 1504 can be placed within their respective bands 502, catheter 506, and buckle 512 (eg, against their inner walls), otherwise this A portion of such a band 502, catheter 506, and buckle 512 may include a protrusion extending outward from it and receiving at least a portion of the corresponding pressure sensors 500, 504, 510, 1504. Other structures for receiving pressure sensors 500, 504, 510, 1504 within or near the band 502, catheter 506, or buckle 512 will also be apparent to those skilled in the art.

Regardless of position, the pressure sensors 500, 504, 510, 1504 can include any pressure sensor suitable for in-stock use and can be customized for a particular application. Examples of suitable suppliers of pressure sensors are CardioMEMS, Integrated Sensing Systems (ISSYS), and Lemon Medical (Remon). Medical) can be mentioned. Exemplary pressure sensors include, but are not limited to, capacitive pressure sensors, piezoresistive pressure sensors, silicon strain gauge pressure sensors, or ultrasonic (acoustic) pressure sensors. In addition, active or passive telemetry comprises these pressure sensors to receive pressure data from pressure sensors 500, 504, 510, 1504 using any of the techniques described above or any other suitable technique. be able to. As a mere example, telemetry can be made possible using RF, ultra-wideband (UWB), ultrasound, or any other suitable communication method. It should be understood that any protocol of any communication format (eg Bluetooth) can be used. Thus, the pressure sensors 500, 504, 510, 1504 can all include or communicate with a telemetry element (eg, coil, transmitter, etc.). If the telemetry elements of the pressure sensors 500, 504, 510, 1504 cannot reach the external telemetry device of patient 34 without assistance, any suitable number of relays (not shown) or other device can be used as such assistance. Can be used.

In another embodiment, a plurality of pressure sensors 500, 504, 510, 1504 are used. For example, the gastric band system can include a pressure sensor 500 within the gastric band 502 in addition to the pressure sensor 504 within the catheter 506 fluidized to the gastric band 502. Such a plurality of pressure sensors 500, 504 can indicate how much the fluid pressure is dispersed within the elements of the gastric band system. Such multiple pressure sensors 500, 504 can also more accurately indicate pressure measurements and reduce the possibility of catheter obstruction (eg, stenosis) affecting the pressure measurements, patient movement. The effect of changes in hydrostatic pressure due to can be reduced or various other results can be imparted. Any system, including multiple pressure sensors, may have a pressure sensor in ports 42, 1142 and / or an external pressure sensor in patient 34 (eg, in addition to any of the internal pressure sensors 500, 504, 510, 1504 described above). It should be understood that the pressure sensor 426 within the injector 400 or the pressure sensor portion 1426 coupled to the injector 400) can be included. In addition, a device such as an internal or external inclinometer (or alternative) is used to determine the angle at which the patient 34 and / or the implant 32 is facing (eg, standing, lying, etc.). However, this angle can be included in the elements of the pressure data detected by one or more sensors 500, 504, 510, 1504 to consider the effect of hydrostatic pressure caused by the orientation of patient 34. Such factors (or any other factor) can be taken into account before or during the pressure measurement.

In this example, each pressure sensor 500, 504, 510, 1504 is enclosed so that the inclusion of the pressure sensors 500, 504, 510, 1504 does not affect the pressure of the fluid in the implant 32. Of course, the pressure sensors 500, 504, 510, 1504 can be arranged without being enclosed. The inventor believes that any of the pressure sensors described above, including, but not limited to, pressure sensors 500, 504, 510, 1504, can detect pressure in any variety of ways. For example, the pressure can be detected by detecting the displacement of a member such as a diaphragm. Since the degree of such displacement can be a function of the force applied to such a member, the pressure value can be obtained by including the known surface area as an element. If calculations are needed to determine the pressure as a function of displacement, such calculations can be done within the sensor or elsewhere. Pressure can be detected by a variety of other methods besides detecting displacement. For example, the pressure sensor can include a strain gauge configured to measure twist in the member. Other structures and techniques suitable for pressure detection or measurement will also be apparent to those of skill in the art. The particular structures and techniques for detecting or measuring pressure disclosed herein are not considered to be of great importance and the inventor may use any suitable structure and technique for measuring pressure. I believe.

In addition to detecting the pressure of the fluid in the implant 32 described in the various embodiments described above, the pressure of the fluid in the esophagus 48, upper sac 50, and / or stomach 40 is also optional, such as an endoscopic tonometer. It should be understood that it can be detected using a suitable device of. As a mere example, pressure measurements of such fluids can be compared to measured pressures of fluid in the implant 32 before, during, and / or after adjusting the pressure in the implant 32. Other suitable uses of pressure measured within the esophagus 48, upper sac 50, and / or stomach 40 will also be apparent to those of skill in the art.

Those skilled in the art will readily appreciate that the invention described above is equally applicable to other types of implantable bands. For example, bands are used to treat fecal incontinence. An example of such a band is disclosed in US Pat. No. 6,461,292, which is incorporated herein by reference. Bands can also be used to treat urinary incontinence. An example of such a band is disclosed in US Patent Application No. 2003/0105385, which is incorporated herein by reference. Bands can also be used for heartburn and / or acid reflux. An example of such a band is disclosed in US Pat. No. 6,470,892, which is incorporated herein by reference. Bands can also be used to treat impotence. An example of such a band is disclosed in US Patent Application No. 2003/0114729, which is incorporated herein by reference.

Although the present invention has been illustrated using some embodiments, the applicant is not intended to limit or limit the concept and scope of the appended claims. Various other modified, modified, and alternative forms will be apparent to those skilled in the art without departing from the scope of the invention. For example, the devices and methods of the present invention have illustrated the placement of pressure sensors within injection ports. Alternatively, the pressure sensor can be placed within the fluid-filled portion of the band to measure pressure changes within the band. In addition, the pressure sensor can be coupled to an elastic balloon implanted in the gastric cavity to measure the pressure of the fluid in the balloon. The structure of each element related to the present invention can also be described as a means for performing the function performed by these elements, as an alternative method. It should be understood that the above description is merely exemplary and one of ordinary skill in the art will come up with other modifications without departing from the appended claims.

[Implementation mode] (1) In the external pressure detection system (a) A connecting member that is connectable to a syringe barrel, is also connectable to a needle, and has a conduit that, when connected to the syringe barrel and the needle, allows fluid to communicate from the syringe barrel to the needle. With connecting members (b) A pressure sensor that communicates fluid with the conduit and is configured to detect the pressure of the fluid in the connecting member. Including The connecting member is configured such that the pressure sensor can detect the pressure of the fluid while the fluid communicates from the barrel to the needle. External pressure detection system. (2) In the external pressure detection system according to embodiment (1), The pressure sensor is an external pressure detection system arranged in the connecting member. (3) In the external pressure detection system according to embodiment (1). Display device, Including The display device is an external pressure detection system capable of displaying information about the pressure detected by the pressure sensor. (4) In the external pressure detection system according to embodiment (1), A communication device connected to the pressure sensor, Including The communication device is an external pressure detection system configured to transmit pressure data obtained by the pressure sensor to a display device. (5) In the external pressure detection system according to embodiment (4). The communication device is an external pressure detection system including a cable.

(6) In the external pressure detection system according to embodiment (4). The communication device includes one or more LEDs. The one or more LEDs are external pressure detection systems capable of transmitting pressure data by infrared light. (7) In the external pressure detection system according to embodiment (4). The communication device includes an RF coil. An external pressure detection system in which the RF coil can transmit pressure data via RF signals. (8) In the external pressure detection system according to embodiment (1), With the syringe barrel With the needle Including An external pressure sensing system in which the pressure sensor is substantially in series with the syringe barrel and the needle. (9) In the external pressure detection system according to embodiment (1), The connecting member is an external pressure detection system including a two-way luer valve. (10) In the external pressure detection system according to embodiment (1). (a) A tube in which fluid communicates with the connecting member, (b) A pressure sensor housing in which the pressure sensor is arranged in the pressure sensor housing and the pressure sensor housing is fluid-communication with the tube. Including an external pressure detection system.

(11) In the external pressure detection system according to embodiment (10). An external pressure sensing system in which the tube and the connecting member are filled with a fluid before the connecting member is connected to the syringe barrel and the needle. (12) In the external pressure detection system according to embodiment (1). The connecting member is an external pressure detection system without a stopcock. (13) In the external pressure detection kit (a) Syringe (i) barrel, (ii) A plunger, and a plunger, wherein at least a portion thereof is configured to fit within the barrel. (iii) Needle, With a syringe, (b) A pressure detection system (i) A generally T-shaped member that defines a flow path that is configured to fit between the barrel and the needle and that allows fluid to communicate from the barrel to the needle. , Generally T-shaped member, (ii) In a pressure sensor, when the generally T-shaped member is attached between the barrel and the needle, the fluid flows from the barrel to the needle or from the needle to the barrel. A pressure sensor and a pressure sensor configured to detect the pressure of a fluid in the pressure detection system. (iii) A communication device connected to the pressure sensor, capable of transmitting data obtained by the pressure sensor to a data processor. With a pressure detection system, Including external pressure detection kit. (14) In the external pressure detection kit according to embodiment (13), The pressure sensor is an external pressure detection kit that is arranged in the generally T-shaped member. (15) In the external pressure detection kit according to embodiment (14), An external pressure detection kit in which the pressure sensor is arranged close to the flow path of the generally T-shaped member.

(16) In the external pressure detection kit according to embodiment (13), The pressure sensing system further includes a tube connected to the T-shaped member. The tube is an external pressure detection kit arranged between the T-shaped member and the pressure sensor. (17) In the method for measuring the pressure of the fluid in the implanted device from the outside, (a) The step of preparing the syringe assembly, The syringe assembly (i) Syringe barrel containing fluid, (ii) A plunger, and at least part of which is located within the syringe barrel, and (iii) The barrel has a fluid-communication needle. Steps and (b) A step of preparing an external pressure sensor in fluid communication with the syringe assembly, wherein the external pressure sensor is located outside the patient. (c) In the step of inserting the needle of the syringe assembly into the body of the patient, the needle is inserted into a fluid injection port arranged in the body of the patient, and the fluid injection port is inserted into the fluid injection port. Steps, including fluids, (d) A step of adjusting the pressure of a fluid in the injection port, comprising pushing or pulling the plunger against the syringe barrel to add or remove fluid to the port. , (e) A step of obtaining pressure data with the external pressure sensor, wherein the pressure data is related to the pressure of the fluid communicating from the barrel to the needle. Including The step of obtaining the pressure data and the step of adjusting the pressure of the fluid in the injection port are performed substantially at the same time. Method. (18) In the method described in embodiment (17), (a) The step of processing the obtained pressure data and (b) A step of displaying the processing result of the obtained pressure data to the user by a visual display, and Including further, methods. (19) In the method described in embodiment (18), The method of displaying, wherein the step is performed after the adjustment step. (20) In the method described in embodiment (17), The method, wherein the pressure sensor is located within a connector located between the syringe barrel and the needle.

<figref num="1">It is a schematic explanatory drawing of the exemplary food intake restriction device.</figref><figref num="2">FIG. 1 is a more detailed perspective view of an exemplary implantable portion for the food intake restriction device of FIG.</figref><figref num="3">FIG. 2 is a perspective view of the adjustable gastric band of FIG. 2, showing a band placed around the junction of the patient's stomach and esophagus.</figref><figref num="4">FIG. 2 is a cross-sectional view of the adjustable gastric band of FIG. 2 shown in the contracted structure.</figref><figref num="5">FIG. 2 is a cross-sectional view of the adjustable gastric band of FIG. 2 shown in an inflated structure that limits food intake.</figref><figref num="6">It is a partial side sectional view of the injection port shown in FIG.</figref><figref num="7">It is an isometric view of the holding cover shown in FIG.</figref><figref num="8">It is an isometric view of the pressure sensor shown in FIG.</figref><figref num="9">It is a side sectional view illustrating an exemplary pressure detection system.</figref><figref num="10">It is a simple schematic diagram of the variable resistance circuit of the pressure detection system of FIG.</figref><figref num="11">FIG. 6 is a side sectional view of an alternative exemplary pressure sensing system.</figref><figref num="12">FIG. 5 is a block diagram representing a pressure measurement system associated with the pressure detection systems of FIGS. 9 and 11.</figref><figref num="13">FIG. 6 is a side sectional view of an alternative exemplary pressure sensing system.</figref><figref num="14">It is a block diagram which represents the pressure measurement system related to the pressure detection system of FIG.</figref><figref num="15">It is a side sectional view of an alternative pressure detection system.</figref><figref num="16">It is a side sectional view of an alternative pressure detection system.</figref><figref num="17">FIG. 5 is a block diagram representing a pressure measurement system associated with the pressure detection systems of FIGS. 15 and 16.</figref><figref num="18">It is a graph which shows the pressure signal from the pressure detection system which is displayed on the external monitor display at the time of inquiry by a user.</figref><figref num="19">FIG. 6 is a side sectional view of an alternative exemplary pressure sensing system.</figref><figref num="20">FIG. 6 is a side sectional view of an alternative exemplary pressure sensing system.</figref><figref num="21">FIG. 3 is an oblique cross-sectional view of an alternative exemplary pressure sensing system.</figref><figref num="22">It is a perspective view of an exemplary detection head.</figref><figref num="23">It is a top view of the detection head of FIG.</figref><figref num="24">It is a side sectional view of the detection head seen along the line 24-24 of FIG.</figref><figref num="25">It is a side sectional view of the detection head seen along line 25-25 of FIG.</figref><figref num="26">FIG. 5 is a plan view of an alternative exemplary detection head.</figref><figref num="27">FIG. 5 is a perspective view of an exemplary display device suitable for connection to the detection head of FIG.</figref><figref num="28">It is an exemplary graphic display suitable for the display device of FIG. 27.</figref><figref num="29">FIG. 28 is a graphic display of FIG. 28 showing the proper placement of the detection heads of FIG.</figref><figref num="30">It is an assembly disassembled perspective view of an exemplary syringe system equipped with a pressure sensor and a display device.</figref><figref num="31">It is sectional drawing of the pressure detection part of the syringe system of FIG.</figref><figref num="32">FIG. 30 is a perspective view of an exemplary infrared communication device suitable for use in the syringe system of FIG.</figref><figref num="33">FIG. 30 is a perspective view of an exemplary RF communication device suitable for use in the syringe system of FIG.</figref><figref num="34">FIG. 6 is a schematic representation of an alternative exemplary pressure sensing syringe system.</figref><figref num="35">FIG. 34 is a perspective view of a reusable sensor portion of the pressure sensing syringe system of FIG.</figref><figref num="36">FIG. 34 is a partial perspective view of a disposable cap portion of the pressure sensing syringe system of FIG. 34.</figref><figref num="37">It is an assembly disassembled perspective view of an alternative syringe equipped with a pressure sensor.</figref><figref num="38">It is a perspective view of the gastric band system in which the pressure sensor is arranged in the gastric band.</figref><figref num="39">It is a schematic diagram of the gastric band system in which the pressure sensor is arranged in the catheter.</figref><figref num="40">FIG. 3 is a perspective view of a gastric band system in which an alternative pressure sensor is placed along the catheter.</figref><figref num="41">FIG. 6 is a schematic representation of a gastric band system in which a removable pressure sensor is placed along the catheter.</figref><figref num="42">It is a schematic diagram of a gastric band system in which a pressure sensor and an alternative catheter are arranged.</figref><figref num="43">FIG. 3 is a perspective view of a gastric band system in which a pressure sensor is located on the buckle of the gastric band.</figref>