BY

SEAN SNOW AND JANEL A. BIRK

RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent

Application Serial Number 12/712,833, filed on February 25, 2010, the entire disclosure of which is incorporated herein by this specific reference.

FIELD

[0002] The present invention generally relates to medical systems and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and more specifically, relates to pressure sensing for gastric banding systems.

BACKGROUND

[0003] Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, CA) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, CA) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts the food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach provides a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract .

[0004] Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid access port connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion, for example, by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction. The level of constriction is related to the amount of fluid in the gastric band system. The level of constriction is also related to the pressure within the gastric band system.

[0005] An implantable pressure sensor for monitoring blood pressure is disclosed in U.S. Patent No. 5,120,313 to Elftman. However, the system of Elftman is percutaneous and extends partially outward from the skin, and is thus unsuitable for complete implantation.

[0006] A previous attempt to provide a medical pressure sensor may be found in U.S. Patent No. 5,554,113 to Novak et al . While the Novak sensor is sterilizable, it is not fully implantable and requires a percutaneous conduit.

[0007] Other attempts to provide a medical pressure sensor may be found in U.S. Patent No. 6,024,704 to Meador et al . and in U.S. Patent No. 5,535,752 to Halperin et al . However, although the sensors of Meador and Halperin are implantable, they are energized by an implanted battery, and both are specifically intended for use within the heart and in connection with an implanted pulse generator.

[0008] Yet another attempt to provide a medical pressure sensor may be found in U.S. Patent No. 6,221,024 to Miesel. The sensor of Miesel utilizes an incompressible oil as a pressure transfer medium, but does not address minimizing damaged caused by thermal expansion.

[0009] Still another attempt to provide a medical pressure sensor may be found in U.S. Patent No. 7,021,147 to Subramanian et al . The sensor of Subramanian addresses thermal expansion but limits the scope to utilizing fillers with low or negative coefficients of thermal expansion.

[0010] A prior attempt to provide pressure monitoring for a gastric banding system may be found in U.S. Patent Application Publication No. 2006/0189888 by Hassler et al . However, the pressure sensor of Hassler is specifically part of the access port, and thus does not permit the pressure sensor to be used with preexisting access ports.

[0011] Another prior attempt to provide pressure monitoring for a gastric banding system may be found in U.S. Patent Application Publication No. 2008/0221598 by Dlugos et al . However, the pressure sensors of Dlugos do not confer strain relief or puncture resistance features.

[0012] It remains desirable to monitor pressure within a gastric band system. Thus, tubing-based pressure sensors for gastric banding systems are described herein.

SUMMARY

[0013] Generally described herein are pressure sensors for gastric band systems, and methods of use thereof. The

apparatus, systems and methods described herein aid in

facilitating obesity control and/or treating obesity-related diseases, and may be non-invasive once implanted.

[0014] In one embodiment, an implantable device is configured for monitoring static and fluctuating pressure levels of a fluid moving to and from an inflatable portion of a gastric band. The implantable device comprises a housing defining a cavity and having an open top portion, and a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting the fluid. The implantable device further comprises a pressure transfer fluid located within the cavity, and a sensing element, positioned within the cavity of the housing and positioned adjacent to the flexible membrane. The sensing element measures a pressure on the flexible membrane. The pressure is caused by the fluid contacting the outer surface of the flexible membrane. The sensing element converts the pressure to a pressure signal.

[0015] The implantable device further comprises a

microcontroller positioned within the cavity of the housing and coupled to the sensing element. The microcontroller is

configured to transmit the pressure signal received from the sensing element to a location external to the implantable device .

[0016] In another embodiment, an implantable device is

configured to monitor a pressure of fluid within an inflatable portion of a gastric band. The implantable device comprises a tube defining a lumen and having a first end and a second end. The second end is connected to the inflatable portion of the gastric band for allowing the fluid to flow through the lumen. The implantable device further comprises a pressure sensor positioned within at least one of the lumen or the tube. The pressure sensor is configured to sense the pressure of the fluid within the inflatable portion of the gastric band, and the pressure sensor is configured to transmit a pressure signal based on the pressure to a remote control device. Further, the pressure sensor comprises a rigid housing conferring strain relief upon at least a portion of the tube, and the pressure sensor shields at least a portion of the tube from puncture by a needle . [0017] In another embodiment, a system is configured to facilitate obesity control. The system comprises an implantable gastric banding device including an inflatable member for containing fluid and restricting a patient's cardia, and an implantable access port coupled to the implantable gastric banding device via tubing. The implantable access port is configured to control pressure within the inflatable member.

[0018] The system further comprises an external remote control device capable of communicating with and powering a pressure sensor and the pressure sensor disposed at least partially within the tubing. The pressure sensor comprises a housing defining a cavity and having an open top portion, and a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting a fluid within the tubing.

[0019] The pressure sensor further comprises a pressure transfer fluid located within the cavity, and a sensing element,

positioned within the cavity of the housing and positioned adjacent to the flexible membrane. The sensing element is configured to measure a pressure on the flexible membrane. The pressure is caused by the fluid contacting the outer surface of the flexible membrane. The pressure sensor is configured to convert the pressure to a pressure signal, and to transmit the pressure signal to a remote device.

[0020] In another embodiment, a system is configured to

facilitate obesity control. The system comprises an implantable gastric banding device including an inflatable member for containing fluid and restricting a patient's cardia, an

implantable fluid reservoir, and an implantable pump unit for controlling pressure within the inflatable member. The

implantable pump unit is in communication with the fluid

reservoir and the gastric banding device via tubing. [0021] The system further comprises an implantable access port coupled to the implantable pump unit, an external remote control device capable of communicating with and powering the

implantable pump unit and a pressure sensor, and the pressure sensor disposed at least partially within the tubing.

[0022] The pressure sensor comprises a housing defining a cavity and having an open top portion, and a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting a fluid within the tubing.

[0023] The pressure sensor further comprises a pressure transfer fluid located within the cavity, and a sensing element,

positioned within the cavity of the housing and positioned adjacent to the flexible membrane. The sensing element is configured to measure a pressure on the flexible membrane. The pressure is caused by the fluid contacting the outer surface of the flexible membrane. The pressure sensor is configured to convert the pressure to a pressure signal. The pressure sensor further comprises a microcontroller positioned within the cavity of the housing and coupled to the sensing element. The

microcontroller is configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a remote device.

[0024] In another embodiment, a method of retrofitting a tubing- based pressure sensor to a previously implanted gastric banding system is provided. The method comprises removing a portion of existing tubing from the gastric banding system, and inserting a portion of new tubing into the gastric banding system. The portion of the new tubing contains at least one pressure sensor disposed at least partially therein.

[0025] The pressure sensor comprises a housing defining a cavity and having an open top portion, and a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting a fluid within the tubing.

[0026] The pressure sensor further comprises a pressure transfer fluid located within the cavity, and a sensing element,

positioned within the cavity of the housing and positioned adjacent to the flexible membrane. The sensing element is configured to measure a pressure on the flexible membrane. The pressure is caused by the fluid contacting the outer surface of the flexible membrane. The pressure sensor is configured to convert the pressure to a pressure signal. The pressure sensor further comprises a microcontroller positioned within the cavity of the housing and coupled to the sensing element. The

microcontroller is configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a location external to the pressure sensor.

[0027] The method further comprises coupling the portion of the new tubing to at least one of: a previously implanted access port, a previously implanted pump, or a portion of the existing tubing .

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1A illustrates an overall schematic view of an example configuration of components according to an embodiment of the present invention.

[0029] FIG. IB illustrates an overall schematic view of an example configuration of components according to an embodiment of the present invention.

[0030] FIG. 2 illustrates a pressure sensor disposed in a strain relief portion located between an access port and tubing in an example configuration of components according to an embodiment of the present invention. [0031] FIGS. 3A through 3D illustrate cross-sections of an example tubing incorporating a pressure sensor according to an embodiment of the present invention.

[0032] FIGS. 4A and 4B illustrate cross-sections of tubing having an example sensor disposed in the tubing wall according to an embodiment of the present invention.

[0033] FIG. 4C illustrates an example configuration of

components including a hard connector and stress relief

components according to an embodiment of the present invention.

[0034] FIGS. 5A and 5B illustrate cross-sections of an example pressure sensor according to an embodiment of the present invention .

[0035] FIG. 5C illustrates example components of a

microcontroller and a pressure transducer according to an embodiment of the present invention.

DETAILED DESCRIPTION

[0036] The present invention generally provides pressure sensing for gastric banding systems, for example, for treatment of obesity and obesity related conditions.

[0037] Turning now to FIG. 1A, a gastric banding system 100A in accordance with one embodiment of the present invention

generally includes an access port 102, a tubing 104, a gastric band 106 having at least one inflatable member 107, a pressure sensor 108, and a remote controller unit 110 (not shown) . Each of the components of the system 100, other than the remote controller unit 110, is implantable in a patient using

conventional surgical techniques. The access port 102 may be used, for example, with a hypodermic needle, to fill and drain the gastric band 106, for example responsive to pressure

measured by the pressure sensor 108 and communicated to the remote controller unit 110. [0038] Turning now to FIG. IB, a gastric banding system 100B in accordance with another embodiment of the present invention generally includes an access port 102, a tubing 104, a gastric band 106 having at least one inflatable member 107, a pressure sensor 108, a remote controller unit 110 (not shown), a

reservoir 112, and a high precision pump unit 114. Each of the components of the system 100B, other than the remote controller unit 110, is implantable in a patient using conventional

surgical techniques. The high precision pump unit 114 can be used to complement or replace the access port 102 for adjusting inflation of the gastric band 106, for example, responsive to pressure measured by the pressure sensor 108. The high

precision pump 114 may also include a microcontroller or a microprocessor to receive a telemetric signal from the remote controller unit 110. The microcontroller or the microprocessor may be used to the control the high precision pump 114.

[0039] With reference to FIGS. 1A and IB, in various example embodiments, one or more pressure sensors 108 are coupled to the tubing 104. When compared to conventional gastric banding systems having no pressure sensing components, or having

pressure sensing components integrated into access ports, pumps, and/or the like, the presently described systems and apparatus offer several benefits. By locating the pressure sensor 108 within the wall of the tubing 104 and/or within the tubing 104 lumen, the tubing 104 incorporating the pressure sensor 108 may be easily retrofitted to preexisting access ports.

Additionally, by locating the pressure sensor 108 within the wall of the tubing 104 and/or within the tubing 104 lumen, interference between the pressure sensor 108 and electrical and/or mechanical components of an access port, a pump, a valve, or other components of a gastric banding system may be reduced and/or eliminated, for example due to increased spacing between the pressure sensor 108 and other components. Further, locating the pressure sensor 108 within the wall of the tubing 104 allows the pressure sensor 108 to confer additional puncture resistance to at least the corresponding portion of the tubing 104.

Moreover, utilization of a substantially rigid pressure sensor 108 and/or associated hard connectors and/or other components allows the pressure sensor 108 to act as partial strain relief for the tubing 104.

[0040] Further, by locating the pressure sensor 108 away from the access port, the pump, the valves, and/or other components of a gastric banding system, certain electrical portions of the pressure sensor 108, such as antenna, are not affected by metal parts which may be in such other components of a gastric banding system. In this manner, the pressure sensor 108 can achieve improved powering and/or communication ranges due to the reduced interference .

[0041] Referring again to FIG. IB, in an example embodiment, the high precision pump unit 114 is connected to the reservoir 112 and the gastric band 106 via the tubing 104, and can move precisely metered volumes of fluid in or out of the gastric band 106. Moving the fluid into the gastric band 106 causes

inflation of at least one bladder, or inflatable member 107 of the gastric band 106 and constricts around the cardia, or upper portion of the stomach, forming a stoma that restricts the passage of food into a lower portion of the stomach. This stoma can provide a patient with a sensation of satiety or fullness that discourages overeating. In contrast, moving fluid out of the at least one inflatable member 107 of the gastric band 106 contracts the pressure around the cardia and allows a stoma to be at least partially released and regains the patient's hunger sensation .

[0042] The high precision pump unit 114 is implanted within a patient, and therefore, is non-biodegradable. The encasement of the high precision pump unit 114 may be non-hermetically or hermetically sealed from the in situ environment and at least partially formed of any rugged plastic material, including polypropylene, cyclicolephin co-polymer, nylon, and other compatible polymers and the like, or at least partially formed of a non-radioopaque metal. The encasement has a smooth

exterior shape, with no jagged edges, to minimize foreign body response and tissue irritation. The unit itself is also

sterilizable, preferably dry heat sterilizable before

implantation .

[0043] In one example embodiment, the encasement or housing of the high precision pump unit 114 has an internal volume of between about 0.75 in ³ to about 1.6 in ³ . The high precision pump unit 114 can be arranged in any fashion appropriate for

delivering and removing precise amounts of fluid from the gastric band 106 and the reservoir 112.

[0044] The high precision pump unit 114 can be actively or passively driven. If the high precision pump unit 114 is actively driven, a local power source such as a battery (not shown) is provided to drive the high precision pump unit 114. If the high precision pump unit 114 is passively driven, it may be inductively powered by a device external to the high

precision pump unit 114. In an exemplary configuration, the high precision pump unit 114 is passively driven through

inductive power, for example, power delivered by the remote controller unit 110. In one example embodiment, the high precision pump unit 114 is an inductively powered, electrically driven, positive displacement piezoelectric pump. The high precision pump unit 114 provides one means to move fluid into and/or out of the gastric band 106 and/or the reservoir 112.

[0045] In an example embodiment, the high precision pump unit 114 can move fluid from the reservoir 112 to the gastric band 106 at rates higher than about 0.5 cc/min, for example higher than about 1 cc/min for band pressures less than about 10 psi (about 138 kPa) relative to the reservoir pressure.

Alternatively, fluid can be drained from the gastric band 106 to the reservoir 112 at rates higher than about 0.5 cc/min, for example, higher than about 1 cc/min for band pressures above about 0.2 psi (about 1.38 kPa) .

[0046] Additional details regarding adjustable gastric banding systems and exemplary components thereof may be found in Birk, U.S. Patent Application Publication No. 2009/0270904, and Birk, U.S. Patent Application Publication No. 2007/0156013, each of which are commonly assigned herewith and incorporated in their entirety herein by this specific reference.

[0047] In an example embodiment, the reservoir 112 is a soft, collapsible balloon made of a biocompatible polymer material, for example, silicone, which holds a reserve of a biocompatible fluid, for example, saline, to allow for adjustments in the size of the gastric band 106. The reservoir 112 is preferably fully collapsible and can contain the extra fluid required to increase the volume of the gastric band 106 to therapeutic levels.

Further, the reservoir 112 also may have excess capacity so the gastric band 106 may be fully drained into it without the reservoir 112 being filled beyond its maximum capacity.

[0048] The fluids used within the systems include any fluid that is biocompatible. Consequently, the fluid has no adverse effect on the patient in the unlikely event that a leak emanates from the system. The fluid can simply be water or any biocompatible polymer oil such as caster oil. In an example embodiment, the fluid is saline.

[0049] The tubing 104 is any biocompatible flexible tubing that does not degrade in vivo. The tubing 104 is configured to withstand hydraulic forces up to about 30 psi (about 206 kPa) without leakage. This hydraulic pressure tolerance is true of the entire fluid path of the systems described herein. Although the systems described herein do not generally leak, if they do, in general fluid is not lost at a rate greater than about

0.2cc/yr, or about O.lcc/yr.

[0050] Other biocompatible and biostable polymers which are useful for forming the reservoir 112 and/or the tubing 104 include polyolefins, polyisobutylene and ethylene-alphaolefin copolymers; acrylic polymers and copolymers, ethylene-co- vinylacetate, polybutylmethacrylate, vinyl halide polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidene halides, such as polyvinylidene fluoride and polyvinylidene chloride;

polyacrylonitrile, polyvinyl ketones; polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers, acrylonitrile- styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66 and polycaprolactam; alkyd resins; polycarbonates; polyoxymethylenes ; polyimides; polyethers; epoxy resins, polyurethanes ; rayon; rayon- triacetate; cellulose, cellulose acetate, cellulose butyrate; cellulose acetate butyrate; cellophane; cellulose nitrate;

cellulose propionate; cellulose ethers; and carboxymethyl cellulose .

[0051] Turning now to FIG. 2, in an example embodiment, an access port 202 is coupled to a tubing 204 via a strain relief portion 206. A pressure sensor 208 is disposed within the strain relief portion 206. The strain relief portion 206 may comprise a thickened portion of the tubing 204; alternatively, the strain relief portion 206 may comprise a material different from the tubing 204. In these embodiments, the pressure sensor 208 may be disposed within the strain relief portion 206 in a location configured to allow the pressure sensor 208 to detect changes in the pressure in the fluid passing through the strain relief portion 206 and/or the tube 204. Additionally, the strain relief portion 206 and/or the pressure sensor 208 help protect the tubing 204 from errant needle sticks, for example, needle sticks intended to contact the nearby access port 202. For example, the pressure sensor 208 may comprise material resistant to puncture by a sharp object.

[0052] Moreover, in accordance with principles of the present invention, a pressure sensor may be integrated into and/or coupled to the tubing 104 in any suitable manner. For example, various configurations of a pressure sensor 308 as integrated into and/or contained within a tubing 304 are illustrated in FIGS. 3A through 3D. In one example embodiment illustrated in FIG. 3A, at least a portion of the tubing 304 has a generally rectangular cross-section and defines an inner lumen 310. The pressure sensor 308 is disposed within the tubing 304 adjacent to the lumen 310. In this configuration, the pressure sensor 308 and the lumen 310 may be aligned "side by side" with respect to the skin of a patient.

[0053] In another example embodiment illustrated in FIG. 3B, at least a portion of the tubing 304 has a somewhat "bullef'-shaped cross section and defines an inner lumen 310. The pressure sensor 308 is disposed within the tubing 304 adjacent to the lumen 310. In this configuration, the pressure sensor 308 and the lumen 310 may be aligned "top and bottom" with respect to the skin of a patient. In this manner, the pressure sensor 308 and/or the tubing 304 may at least partially protect the lumen 310 from damage or puncture, for example, from errant needle sticks. Moreover, any suitable cross-sections of the tubing 304 and/or the pressure sensor 308 may be aligned "top to bottom" in order to locate the pressure sensor 308 at least partially between a portion of the lumen 310 and an incoming needle or other device which may potentially damage the tubing 304.

[0054] In another example embodiment illustrated in FIG. 3C, at least a portion of the tubing 304 has a somewhat "egg"-shaped cross section and defines a similarly shaped inner lumen 310. In this configuration, the tubing 304 may also be considered to have a cross-section resembling a conical frustum configured with partially rounded edges. The pressure sensor 308 is disposed within the lumen 310. In this manner, the pressure sensor 308 may be in direct contact with the fluid contained in the lumen 310 while still allowing flow of the fluid through the lumen 310, for example, when the pressure sensor 308 is

configured with a substantially circular cross-section or other cross-section different from the cross-section of the lumen 310.

[0055] In another example embodiment illustrated in FIG. 3D, at least a portion of the tubing 304 has a circular cross-section. Within the tubing 304, an inner lumen 310 having a cross-section with a main lumen area and a plurality of extensions therefrom is defined. The pressure sensor 308 is disposed within the main lumen area of the lumen 310. In this manner, the pressure sensor 308 may be in direct contact with the fluid contained in the lumen 310 while not obstructing flow of the fluid through the lumen 310 even when the tubing 304 is bent or kinked. For example, when the tubing 304 is bent in a particular direction, one or more of the plurality of extensions from the main lumen area of the lumen 310 may be at least partially blocked, while fluid flow through another of the plurality of extensions may remain substantially unrestricted.

[0056] Moreover, it will be appreciated by one of ordinary skill in the art that many additional shapes, geometries,

configurations, cross-sections, and/or combinations of the tubing 304, the inner lumen 310, and the pressure sensor 308 and/or additional components are possible, and all such are considered to be within the scope of the present invention.

[0057] Turning now to FIG. 4A, a cutaway view of placement of a pressure sensor 408 within an expanded portion of a tubing 404 is illustrated. In an example embodiment, the tubing 404 is configured with a first thickness for a portion of the length of the tubing 404. The tubing 404 is further configured with a second, larger thickness for another portion of the length of the tubing 404. The pressure sensor 408 is disposed within the thicker portion of the tubing 404, for example, in a "pocket" or other recess or cavity at least partially defined by the tubing 404. Moreover, the pressure sensor 408 may be molded into the tubing 404 upon manufacture of the tubing 404. The pressure sensor 408 may also be placed within a void, recess, pocket, or other available space at least partially defined by the tubing 404 subsequent to manufacture of the tubing 404.

[0058] In an example embodiment illustrated in FIG. 4B, the pressure sensor 408 may be retained in the wall of the tubing 404 in connection with the use of a plug 412. The plug 412 may be made of the same material as the tubing 404. The plug 412 may also be made of a different material than the tubing 404, for example, an incompressible material configured to

frictionally couple to the material of the tubing 404. The plug 412 may be at least partially inserted into and/or wedged between portions of the tubing 404. In this manner, the

pressure sensor 408 may be retained in a portion of the tubing 404. The plug 412 may be removed as desired, for example, in order to replace a non-functioning pressure sensor 408, or to upgrade the pressure sensor 408 to a new pressure sensor 408 having expanded functionality, extended communication range, or other desirable properties.

[0059] In another example embodiment illustrated in FIG. 4C, the pressure sensor 408 may be coupled to the tubing 404 at a joint, for example, a joint associated with a hard connector 414. As illustrated, multiple portions of the tubing 404 are each configured with a wider portion having, for example,

complementary cavities therein. The pressure sensor 408 is disposed within the complementary cavities of the tubing 404, and the ends of the tubing 404 are then brought together, such that the pressure sensor 408 is surrounded by the tubing 404. One or more hard connector components 414 may similarly be coupled together, securing the pressure sensor 408 within the tubing 404. Additionally, the expanded thickness of the tubing 404 near the hard connector 414 can confer additional stress relief to the tubing 404.

[0060] FIGS. 5A and 5B illustrate configuration and operation of an exemplary pressure sensor according to an embodiment of the present invention. Referring to FIG. 5A, in an example

embodiment, a pressure sensor 550 is hermetically sealed and comprises a housing 552, for example, a metallic housing, and a membrane 554, both of which may comprise titanium or other non- radioopaque material. The membrane 554 flexes in response to changes in pressure, which affects the pressure transducer 556. Space inside the housing 552 may contain a pressure transfer medium 558, for example, degassed silicone oil or other suitable incompressible pressure transfer medium. The pressure transfer medium 558 may at least partially surround and/or immerse various components within the housing 552, for example, the pressure transducer 556, a microcontroller 560 coupled to the pressure transducer 556, a signal wire 562, and/or the like. In an example embodiment, the surface area of membrane 554 is large in comparison to the volume of the pressure transfer medium occupying the interior of the housing 552.

[0061] As pressure outside the pressure sensor 550 is increased, as illustrated in FIG. 5B, the membrane 554 deflects downward increasing the pressure of the pressure transfer medium 558.

Similarly, as pressure outside the pressure sensor 550 is decreased, the membrane 554 deflects a reduced amount, reducing the pressure on the pressure transfer medium 558. The pressure transducer 556 converts pressure changes into changes in a suitable electromagnetic property, for example, capacitance, inductance, resistance, and/or the like. The changes in the electromagnetic property are proportional to the changed in the measured pressure. The changes in the electromagnetic property are then detected by the microcontroller 560, for example, via periodic and/or continuous polling or other querying of the pressure transducer 556 by the microcontroller 560. The

microcontroller 560 converts the signal from the pressure transducer 556, which may be an analog signal susceptible to noise, interference, and/or the like, into a suitable signal, for example, an analog or digital signal having a suitable signal to noise ratio, configured to be delivered to a remote location. In one example, a signal from the microcontroller 560 passes through the housing 552 via the signal wire 562 which may be configured to be substantially immune to typical levels of electrical noise. In another example, a signal from the

microcontroller 560 may be wirelessly transmitted beyond the confines of the pressure sensor 550, for example, by an antenna or other components integrated with and/or coupled to the microcontroller 560.

[0062] The pressure sensor 550 may further comprise various components, for example, antennas, capacitors, inductors, transistors, electrical couplings, connectors, and/or the like, configured to permit the pressure sensor 550 to communicate with and/or receive operating power from a remote control, for example, remote controller unit 110. Such components may be located on and/or may comprise part of a microcontroller 560. Such components may also be coupled to the microcontroller 560 inside the housing 552. Such components may also be located on the outside of the housing 552, for example in order to

facilitate wireless communication with the remote controller unit 110, or to facilitate wired and/or wireless communication with other components of a gastric banding system (e.g., other sensors, an access port, a pump, and/or the like) . [0063] With additional reference now to FIG. 5C, in an example embodiment the microcontroller 560 comprises an application specific integrated circuit (ASIC) having various memories, signal processors, communications components, power components, temperature sensors, and/or the like. The microcontroller 560 is configured to manage and/or condition incoming electrical power received from the remote controller unit 110, for example via inductive coupling. The microcontroller 560 is further configured to utilize an internal temperature sensor to obtain temperature information. Responsive to temperature information, the microcontroller 560 may perform temperature compensation in order to adjust for changes in the behavior of one or more components of the pressure sensor 550.

[0064] In various example embodiments, the microcontroller 560 stores calibration values associated with one or more components of the pressure sensor 550 in on-board memory on the

microcontroller 560. For example, one or more calibration values may be stored on the microcontroller 560 in order to correct for non-linear behavior and/or offsets associated with one or more components of the pressure sensor 550, for example the pressure transducer 556. The calibration values may be revised and/or updated, as suitable, in order to allow the pressure sensor 550 to report an accurate pressure reading to the remote controller unit 110. Additionally, the

microcontroller 560 may format pressure data, temperature data, and/or other data for transmission to the remote controller unit 110. Moreover, the microcontroller 560 may be configured to respond as a slave to a master unit, for example another

microcontroller 560 in another pressure sensor 550, a

microprocessor in the remote controller unit 110, and/or the like .

[0065] In an example embodiment, the microcontroller 560

comprises an ASIC having a form factor of about 1.5mm by 3.15mm by 0.2mm. In other example embodiments, the microcontroller may have a larger and/or smaller form factor, in order to allow the microcontroller 560 to be placed within the pressure sensor 550 and/or immersed in the pressure transfer medium 558 therein.

[0066] The pressure sensor 550 is configured to withstand high temperatures, for example, temperatures in excess of

temperatures necessary for steam sterilization (e.g.,

temperatures in excess of 120 degrees Celsius) , without damage to the pressure transducer 556 or other components of the pressure sensor 550 caused by expansion of the pressure transfer medium 558. Notably, the pressure sensor 550 achieves this result without resorting to fillers intended to lower the overall thermal expansion coefficient of the pressure transfer medium 558, for example, fillers comprising glass beads, metal fragments, and/or the like, as such fillers can lead to

undesirable increases in manufacturing complexity and/or cost. Additionally, the pressure sensor 550 minimizes the internal volume which is filled with the pressure transfer medium 558 while maximizing the surface area of the membrane 554. This design minimizes the stress on the membrane for a given increase in the temperature of the sensor 550. Moreover, because the pressure sensor 550 receives operational power from the remote controller unit 110, no battery or other implanted power source is required for operation of the pressure sensor 550.

[0067] The pressure sensor 550 in accordance with various exemplary embodiments may comprise a pressure sensor, multiple pressure sensors, including multiple pressure sensors configured to operate in a differential mode, a flow rate sensor, and/or the like or combinations thereof.

[0068] Returning again to FIG. IB, the gastric banding system 100B may comprise a plurality of the pressure sensors 108

disposed, for example, within the tubing 104. In an exemplary embodiment, two pressure sensors 108 are situated within the high precision pump unit 114. During a filling or draining condition, as well as during a no-flow condition, both of the pressure sensors 108 may be used to measure pressure, thereby providing the benefits of redundancy and averaging. Moreover, any suitable number of the pressure sensors 108 may be utilized.

[0069] The systems and apparatus described herein further include the remote controller unit 110 (not shown) , which provides access to system data and functions. The remote controller unit 110 may be an external, handheld, reusable battery-powered device, or any other suitable electronic device. The remote controller unit 110 can be made of any rugged

material, including polypropylene, cyclicolephin co-polymer, nylon, and other compatible polymers and the like. The remote controller unit 110 is not implanted within the patient, so hermetic sealing of the unit is not required. However, the remote controller unit 110 is preferably at least water

resistant, if not waterproof, and may be cleaned using standard hospital disinfectants without damage to the unit.

[0070] Further, the remote controller unit 110 is configured with a user interface including at least one display and at least one user input. In some example embodiments, the display and the user input are combined in the form of a touch screen with a color display. In other embodiments, the display is grayscale. The remote controller unit 110 permits a clinician or a patient to interact with the gastric banding system 100B, for example, by navigating through menu driven screens used for data entry, data collection, and control of other components of the gastric banding system 100B.

[0071] The remote controller unit 110 is capable of

communicating with the pressure sensor 108, the high precision pump unit 114, and/or other components of a gastric banding system, for example, the gastric banding system 100B. "Capable of communicating" as used herein refers to the ability of the remote controller unit 110 to establish communications with other components, yet still have the ability to break

communication and the systems described herein still function. To establish communication, in one example embodiment, once the remote controller unit 110 is initialized, a display shows a searching query for nearby compatible components, for example, the high precision pump unit 114, the pressure sensor 108, and/or the like. As the remote controller unit 110 is brought into range of a compatible component, a symbol displays the strength of the communication link. Once stable communications have been acquired, the display may show the serial number or other identifying indicia of the component or system so a clinician can verify they have the appropriate patient records in hand.

[0072] Via the remote controller unit 110, the clinician can obtain information from and/or issue commands to other

components of the gastric banding system. For example, if the patient requires a tightening of the gastric band 106, the clinician can enter the amount of the desired volume increase. If the patient requires a loosening of the gastric band 106, the clinician can enter the amount of the desired volume decrease. Current and/or logged pressure readings from the pressure sensor 108 may similarly be obtained. The remote controller unit 110 can also display the current and/or desired volume within the gastric band 106 and indicate the new volume as the gastric band 106 fills or drains.

[0073] To verify an appropriate adjustment has been made to the system, the clinician can set the remote controller unit 110 into a pressure monitor mode and request that the patient drink water. The display may show a real time graph of one or more pressure readings measured within the gastric banding system

100B, for example, by one or more of the pressure sensors 108. This diagnostic tool may show higher pressures and warning messages if the gastric band 106 has been over-tightened.

[0074] The remote controller unit 110 can synchronize and charge when coupled with a charging cradle or docking station. This docking station provides the ability to recharge a battery for the remote controller unit 110, and may also provide a link to download information to a personal computer such as the

adjustment history of a patient. Other data that can be stored on the remote controller unit 110 and downloaded from the high precision pump unit 114 and/or the pressure sensor 108 includes, but is not limited to, serial number, gastric band size, patient information, gastric band volume, current pressure, historical pressure, firmware version and patient adjustment history. This data can be downloaded directly to a patient tracking database for ease of tracking.

[0075] Any data stored on the remote controller unit 110, on the pressure sensor 108, and/or on the high precision pump unit 114 can be electronically secured. In other words, security

measures can be put in place to keep the data confidential, including communication between the high precision pump unit 114 and the remote controller unit 110, communication between the high precision pump unit 114 and the pressure sensor 108, and/or other communications between various components of the gastric banding system 100B. Security measures can include computer generated algorithms that prevent intrusion by outside parties.

[0076] In an example embodiment, the pressure sensor 108 is a passive device configured to be powered by and/or communicate with the remote controller unit 110 when it is in close

proximity. For example, in one example embodiment, the remote controller unit 110 may be configured to power and communicate with the pressure sensor 108 at a distance less than about 8 inches, preferably less than about 4 inches (about 10.2 cm) of tissue plus about 4 inches, preferably about 2 inches (about 5.1 cm) of air. Moreover, power and communications can be tailored to transmit over longer distances, or can be tailored to have the remote controller unit 110 placed on the skin adjacent to the pressure sensor 108.

[0077] The remote controller unit 110 can inductively power and telemetrically control the pressure sensor 108. The remote controller unit 110 may be configured to provide continuous power to the pressure sensor 108. In an example embodiment, a dedicated microcontroller within the remote controller unit 110 monitors the amount of power that is transmitted. Further, a power management system may be implemented to optimize energy transmission between the remote controller unit 110 and the pressure sensor 108 relative to their separation distance. For example, the power transmission may automatically decrease as the remote controller unit 110 is moved closer to the pressure sensor 108, and may be increased as the distance is increased. This reduces wasted energy, and energy exposure to the patient.

[0078] Returning to FIGS. 5A and 5B, in an example embodiment, the pressure sensor 550 is a passive device which may be

entirely controlled and powered by the remote controller unit 110. An antenna on the microcontroller 560 housed within the pressure sensor 550 couples to the remote controller unit 110 to allow the transmission of power through the skin and/or

subcutaneous tissue. In another embodiment, the antenna

providing power is located outside of the pressure sensor 550. The power issued from the remote controller unit 110 may be continually monitored by a dedicated microprocessor to ensure that power transmission is suitably reduced and/or minimized to the lowest level required for operation. To reduce the power transmission and to improve command communication, the pressure sensor 108 and the remote controller unit 110 may have a channel frequency dedicated to command communication and a separate channel frequency dedicated to power transmission. The command communication can be configured, for example, to take place at about 402 - 406 MHz while the power transmission, for example, takes place at about 400 kHz. This command communication adheres to the frequency and power standards set by the Medical Implant Communications Service. Other communication and/or power frequency ranges may be utilized, as desired. To ensure accuracy, communication and control commands may be verified prior to data reporting or command implementation, for example, by error checking and/or correction algorithms.

[0079] The systems and apparatus described herein use common surgical techniques to place the components in their respective positions within a patient. The surgical techniques may be identical or similar to those used in the placement of

conventional gastric banding systems. For example, the gastric band 106 may be placed around the stomach using laparoscopic techniques, as known to those of skill in the art. Like a conventional access port, the high precision pump unit 114 and/or the access port 102 may be sutured onto the rectus muscle sheath or any other conveniently accessible muscle. For example, in order to achieve a secure attachment of the high precision pump unit 114, it may be sutured to the rectus muscle and remain securely attached for forces below about 6 pound- force (about 26.6 Newtons) , and preferably below about 3 pound- force (about 13.3 Newtons) . The tubing 104 passes through the rectus muscle into the peritoneal cavity.

[0080] The systems and apparatus of the present invention further allow for remotely monitored pressure and controlled adjustment without needles, non-invasively, by using the remote controller unit 110. Also, should the remote controller unit 110 be unavailable, damaged, out of power, or in the event of an emergency, an adjustment of the gastric band 106 can be

performed invasively using a needle. For example, by using the access port 102 illustrated in FIGS. 1A and IB, a clinician can choose to use a standard needle for adjustments. If any of the electronics associated with the systems and apparatus described herein become inoperable, the access port 102 can be used to add or remove the fluid from the gastric band 106. The access port 102 and a syringe or needle can be used to adjust the gastric band 106.

[0081] The systems described herein generally function as follows. A clinician uses the remote controller unit 110 to query one or more of the pressure sensors 108. The pressure sensors 108 are activated responsive to an energy pulse from the remote controller unit 110. The pressure sensors 108 may then take pressure readings, store pressure values or other

information, and/or transmit current and/or historical pressure values or other information to the remote controller unit 110. Updated configuration information, command information, control information, diagnostic information, reset information, and/or other suitable information may be sent to and/or from the remote controller unit 110 and the pressure sensor 108. Responsive to information from the pressure sensor 108 and/or other suitable information or operating parameters, the remote controller unit 110 may subsequently and/or simultaneously communicate with and/or power the high precision pump unit 114 in order to adjust the gastric band 106. In an example embodiment, the remote controller unit 110 communicates simultaneously with the

pressure sensor 108 and the high precision pump unit 114 in order to monitor pressure changes in the gastric banding system during filling and/or draining of the gastric band 106. In one example, the total power consumed by the pressure sensor 108, the high precision pump unit 114, and all other inductively powered components of gastric banding system 100B during

simultaneous operation thereof is less than 1 watt. In another example, the total power consumed is less than 700 milliwatts. [0082] As described herein, the present systems and apparatus may be compatible with magnetic resonance imaging (MRI), which is much safer for a patient than exposure to X-ray radiation. In one example embodiment, the systems and apparatus described herein are configured and structured to be compatible with MRI, or MRI safe, at magnetic field strengths of up to about 1.5 Tesla. For example, the pressure sensor 108 may be entirely inductively powered. The pressure sensor 108 may utilize no permanent magnets, no long metallic wires or leads, and a minimal or negligible amount of ferrous or ferromagnetic

material. The pressure sensor 108 may be substantially free of or contain substantially no ferromagnetic materials.

Substantially no ferromagnetic materials refers to materials containing less than about 5%, preferably less than about 1% or 0.1% (w/w) of ferromagnetic material. The resulting systems are thus MRI safe given standard specifications regulating

translational and rotational attraction, MRI heating, and imaging artifacts. All materials selected for the systems are preferably selected to be compatible and safe in an MRI

environment .

[0083] Further, the inductive powering of the pressure sensor 108 utilizes energy passed through the body tissue. Since the body tissue absorbs a portion of the energy passing through it, the heating of the body tissue can be proportional to the total energy transferred. To ensure that the systems meet standards to minimize tissue heating (below 2°C above body temperature per ISO 45502), the pressure sensors 108 described herein have been designed to use very little power to measure pressure within the system, for example, less than about 2 milliwatts, or preferably less than about 1.35 milliwatts, and do not cause excessive heating of the patient's body tissue.

[0084] Using the remote controller unit 110 to communicate with the pressure sensor 108, a clinician can monitor pressure inside the gastric band 106, for example, in "real time" during an adjustment of the constriction within the gastric band 106.

This allows the clinician to observe the response of the gastric band 106 to a patient's adjustment. A new modality for gastric band adjustment management is thus enabled, because clinicians can monitor static pressure, as well as pressure and volumes during adjustments. With these pressure sensing capabilities, the clinician can make expanded determinations, for example, whether there is a leak within the system (e.g., an unexpectedly low, declining, or zero pressure reading) , or whether there is an obstruction in the system (e.g., an unexpectedly high

pressure reading or prolonged pressure rise) .

[0085] In one example embodiment of the present invention, components of the systems can be replaced without replacing the entire system and subjecting patients to overly invasive

surgeries to replace entire systems when a single component is defective or damaged. For example, if the pressure sensor 108 becomes damaged, unreliable, or inoperable, it can be replaced independently of other components. Additionally, if multiple pressure sensors 108 are used, the system can continue to operate with a reduced number of operational pressure sensors 108 should one or more of the pressure sensors 108 fail.

[0086] The systems described herein are configured to meet at least one safety specification. For example, in the event of any failure of the systems, either no change in the gastric band 106 tightness or a loosening of the gastric band 106 results. Further, the high precision pump unit 114 and the pressure sensor 108 are biocompatible for long term implantation, and the remote controller unit 110 is biocompatible for transient use both per ISO 10993. The systems are designed to have no

significant interaction or interference with other electronics in any of the following modalities: implantable energy sources such as defibrillators and pacemakers; internal energy sources such as electrosurgical instruments; external energy sources such as ultrasound, x-rays and defibrillators; and

radiofrequency signals such as pacemaker programmers and neuron- stimulators .

[0087] Sensing or measuring the pressure within a gastric banding system, for example within the fluid pathway of the gastric banding system 100B, provides diagnostic uses.

Clinicians can measure pressure while a patient drinks water, recording and analyzing resulting pressure fluctuations which can help determine if the gastric band 106 is too restrictive. A band that is too restrictive can also be confirmed by the patient's response (generally discomfort) upon drinking the water, and can then be appropriately adjusted. Further, sensing or measuring pressure in the gastric banding system 100B can be useful in diagnosing system leaks or obstructions. For example, if the pressure consistently drops over an extended period of time, the clinician can diagnose a leak within the system and plan for an appropriate treatment to fix the problem. In contrast, if there is an obstruction within the system with a sustained pressure rise over time, the clinician can diagnose an obstruction within the system and plan for an appropriate treatment to fix the problem.

[0088] The pressure sensor 108 may be utilized on a short term basis and/or a long term basis. For example, the pressure sensor 108 may be utilized during the course of a patient visit with a clinician, which may be anywhere from a few minutes to several hours in duration. Information from the pressure sensor 108 may be used to analyze changes in pressure which occur during various intentional patient actions, for example,

swallowing. Information from the pressure sensor 108 may also be used to detect unintentional patient actions, for example, smooth muscle fasciculations , reflexive actions, spasming, cramping, and/or the like. [0089] On a longer term basis, the pressure sensor 108 may also be used, for example, to compare pressure readings from one clinical visit to the next, from one year to the next, and/so on. Long-term changes in pressure reported by the pressure sensor 108 may be utilized to detect system leaks, capsular contraction around the stomach, herniation and/or erosions within the stomach, and/or the like. In this manner, the pressure sensor 108 can provide additional information to enable the clinician to determine a suitable course of care for the patient .

[0090] Moreover, the pressure sensor 108 may also be retrofitted to an existing gastric banding system. For example, an existing gastric banding system may be configured with tubing lacking a pressure sensor 108. A minor surgical procedure may replace at least a portion of the existing tubing with the new tubing 104 having one or more pressure sensors 108 therein. Thus, pressure monitoring capabilities can be extended to existing patients without requiring removal and/or replacement of various existing components of their gastric banding systems, for example access ports, gastric bands, pumps, batteries, valves, and/or the like.

[0091] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the

specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported

significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing

measurements .

[0092] The terms "a, " "an, " "the" and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise

indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better

illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the present invention.

[0093] Groupings of alternative elements or embodiments of the present invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims .

[0094] Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the present invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing

description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context .

[0095] Furthermore, numerous references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.

[0096] Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term "consisting of" excludes any element, step, or ingredient not specified in the claims. The transition term "consisting essentially of" limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic ( s ) . Embodiments of the present invention so claimed are inherently or expressly described and enabled herein . [0097] In closing, it is to be understood that the embodiments of the present invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the present invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.