SELF-REGULATED GASTRIC BANDFIELD OF THE INVENTION The present invention relates in general to devices and methods for controlling obesity and, more particularly, a gastric band or gastric band assembly / system, and the corresponding methods, configured for self-monitoring and adjustment of size, for example the internal diameter, of the gastric band to thereby provide continuous adjustment of the size of the stoma in a patient.
BACKGROUND OF THE INVENTION Severe obesity is a chronic and increasingly prevalent condition, which is difficult to treat by physicians in their patients through diet and exercise alone. Gastrointestinal surgery is used by doctors to treat people who are severely obese and can not lose weight by traditional means and who suffer from serious health problems related to obesity. In general, gastrointestinal surgery promotes weight loss by restricting food intake, and more specifically, restrictive operations limit the intake of food by creating a narrow passage or "stoma" from the upper part of the stomach to the lower part of the stomach. lower larger, which reduces the amount of food REF..194398that the stomach can maintain, and retards the passage of food through the stomach. Initially, the stoma was of a fixed size, but doctors have recently determined that the procedure is more effective if the stoma can be adjusted to alter its size. One of the most commonly used of these purely restrictive operations for obesity, is the adjustable gastric band (AGB for its acronym in English). In an exemplary procedure, a hollow band (e.g., a gastric band) made of silicone elastomer is placed around the stomach near its upper end, creating a small pouch and a narrow passage (e.g., a stoma) to the rest of the stomach. The band is then inflated with a saline solution by using a coreless needle and syringe to access a small gate that is placed under the skin. To control the size of the stoma, the gastric band can be tightened or loosened over time by the physician or other technician extracorporeally, by increasing or decreasing the amount of saline in the band via the access gate, to change the size of the passage or the stoma. The provision of fine adjustments of the gastric band after adjustment of the initial size of the stoma has proven to be a significant improvement in the adjustable gastric band procedure. However, there is a difficultycontinues to determine when to further adjust the gastric band and how much to increase or decrease the size of the bands or the diameter thereof to achieve a desired stoma size. Numerous gastric bands have been developed to allow a physician or other technician to adjust an implanted gastric band. In general, these band systems include a sensor for measuring or determining parameters associated with the patient and in response, the physician or technician acts to adjust the fluid volume in the band based on the patient's parameters. For example, an adjustable gastric band system determines when the pressure in a patient's stomach exceeds a pre-set limit, and provides an alarm to an external control device. A doctor or other operator then responds by loosening the gastric band by withdrawing a quantity of fluid from the band via the external access gate and the fill line. In another gastric band system, the components for adjusting the size of the gastric band are implanted within the patient, and when a physical parameter related to the patient, such as the stomach pressure or the patient's physical position, are determined, a unit of external control outside the patient's body, is operated to energize the implanted components, to adjust the size of the band, for example, with addition or removal of a pre-set volume of fluidfrom the band. While improved control over adjustable gastric banding is provided, existing gastric banding does not meet the needs of patients. In part, the deficiencies in the existing adjustable gastric bands are due to the need for the patient to be treated by a physician or other technician, to adjust the size of the gastric band and the stoma formed, via an external control unit. Other deficiencies are related to the non-reliability or imprecision of the detection parameters related to the patient, and the correlation of this to a desired stoma size. In addition, some of the existing gastric bands require sensor insertion into the patient, such as in or on the stomach to determine stomach pressure. Because of these and other limitations of existing technologies, there remains a need for an improved gastric banding system, and associated adjustment methods, for the provision of improved stoma size adjustments in a patient being treated for obesity.
BRIEF DESCRIPTION OF THE INVENTION The present invention addresses the above and other problems by providing a self-regulating gastric band system for implantation in an obese patient,to automatically adjust the size of a stoma on a periodic or continuous basis. The system is "self-regulating" in some embodiments since it includes a sensor to detect a property or parameter of an expandable gastric band, implanted, and a mounting or band adjustment system that adjusts the size of the expandable gastric band, in response to the detected property of the band. For example, a clinician or clinician may establish a range of operation for the property in the system memory before implantation, or later by means of an external control device. The sensor operates periodically, on a progressive basis, or after being activated to detect the properties of the band (such as fluid pressure within an expandable inner ring or band member). The sensor or a controller operates to determine if the band is within the desired range based on the detected property of the band, and if not, the controller acts to adjust the size of the band to bring the band or its property detected. back to the operating range, such as by the operation of a pump assembly to move the fluid between a fluid reservoir and the expandable inner ring. The self-regulating gastric band system also typically includes a housing for enclosing the implanted system components with the gastric band, and a power sourcelocal that is implanted to provide power to various system components such as pumps, the sensor and the controller. In this way, the modalities of the gastric band system can be considered gastric band treatments "put on and forget" for obesity. More particularly, a self-regulating gastric band apparatus is provided to adjust the size of the stoma in a patient. The apparatus includes a gastric band for implantation in a patient. The gastric band has an expandable inner ring with a lumen or cavity to receive a fluid (such as saline). A band adjustment assembly for implantation with the gastric band is provided, and this assembly includes a sensor for detecting a property or parameter of the gastric band, and more typically, the expandable inner ring.(for example, the pressure of the fluid in the inner ring or other property indicating the size of the inner ring, and therefore the size of the gastric band). The band adjustment assembly further includes a pump assembly connected to the lumen of the expandable inner ring, and a controller that can operate the pump assembly to adjust the fluid volume in the lumen, based on the sensed property of the band Gastric The band setting assembly may include some memory that stores an operating range for the particular band property (such as a limit).upper and lower defining an acceptable operating range, for example, two fluid pressure values that define an upper and lower limit of a pressure range), and in this case, the controller (or a programmable sensor) compares the detected property of the band to determine if it is within the operating range. If not, the controller operates the pump assembly either to increase the volume of the fluid in the inner ring, or to decrease the volume of the fluid depending on whether the detected parameter is outside the low or high range.
BRIEF DESCRIPTION OF THE FIGURES Figure 1 illustrates a self-regulating gastric band system (eg, self-monitoring and self-adjusting) according to the present invention, as it may appear when installed in a patient; Figure 2 illustrates a gastric band with an interconnected internal band adjustment system in fluid communication with the lumens of the band as it can be used in a self-regulating gastric band system, such as in the system of the Figure 1; Figure 3 is a cross-sectional view of the gastric band of Figure 2, taken on line 3-3 illustrating the expandable internal lumen used for thefine tuning of the diameter or internal size of the gastric band, and an external lumen that provides a local or internal reservoir for the fluid, for use in the expansion (and deflation or shrinkage) of the expandable, internal lumen; Figure 4 is a functional block diagram of a self-regulating gastric band system according to an embodiment of the present invention; Figure 5 is a schematic and / or functional block diagram of another embodiment of a self-regulating gastric band system of the invention, which more particularly illustrates a pump assembly mode, useful for implementing self-adjusting characteristics of the invention; Figure 6 is a perspective cut-away view of a physical implementation of the pump assembly of the invention, and particularly, of the pump assembly of the system of Figure 5; Figure 7 is a schematic diagram similar to Figure 5, showing yet another embodiment of a self-regulating gastric band system of the invention, using a pump assembly different from the system of Figure 5; Figure 8 is a schematic diagram similar to Figures 5 and 7, showing yet another embodiment of a self-regulating gastric band system of the invention,using a pump assembly that differs from those shown in the systems of Figures 5 and 7; Figure 9 is a schematic diagram similar to Figures 5, 7 and 8 illustrating yet another embodiment of a self-regulating gastric band system of the invention, using another pump assembly useful for practicing the adjustment features of the invention; Figure 10 is a schematic diagram similar to Figures 5, 7, 8 and 9 showing yet another embodiment of a self-regulating gastric band system of the invention, using a pump assembly and the location of the sensor relative to the systems of Figures 5, 7, 8 and 9; Figure 11 is a functional block diagram of the self-regulating and adjustable gastric band system of the invention, using a manual controller that communicates with remote controllers or services (such as controllers or services based on a page of the Internet ) via a telephone connection; Figure 12 is another functional block diagram showing the manual controller and the system support of Figure 11, with additional detail; Figures 13 and 14 are perspective views of an exemplary implementation of a manual controller and support according to the present invention, such as to implement the systems of Figures 10 and 11; YFigure 15 is a flow chart of a normal mode of operating the gastric band system, such as those described in Figures 10 and 11, to regulate the size of an implantable gastric band.
DETAILED DESCRIPTION OF THE INVENTION In summary, the invention is directed to a self-regulating gastric band or a band system that makes it possible for an operator (eg, a physician or technician) to adjust the operational parameters for a gastric band before or after of implantation in a patient. The self-regulating gastric band is then operable to directly monitor the properties of or associated with the gastric band, to determine if these monitored or detected properties are within the operational parameters or established limits, and then, if it is not within the limits , the size of the gastric band is automatically adjusted (for example, its internal diameter that establishes the size of a stoma in the patient's stomach) such that the property or properties monitored or detected are within the current range or limits of operation. The self-regulating gastric band systems of the invention can be used in general with numerous gastric band designs with many modalities that are particularly useful for those that include a portioninflatable or internal lumen that is expanded or contracted by the increase or decrease in the volume of fluid contained in it. In general, the gastric band systems of the invention include one or more sensors for directly detecting a band parameter, such as the fluid pressure in the inflatable portion, and a controller that processes this parameter or property of the detected band, for determine if the fluid in the band is added or removed to fine tune its size (and the corresponding stoma size). A local fluid reservoir that is connected to a pump assembly, which is controlled by the controller for pumping the fluid in or out of the band, may be provided. In one embodiment, the local fluid reservoir is provided within the gastric band itself, for example, in an external lumen or ring or reservoir member. An internal packing line or tube is connected between the pump assembly and the inflatable portion or the gastric band member, to allow the volume to be controlled locally (eg, instead of or in addition to a standard access gate). ). The energy for the pump assembly, the controller and the sensor is also typically provided locally to the gastric band, for example, intracorporeally or adjacent to the stoma and the gastric band in the patient, rather than from an external source of energy such as a energy sourceinduction. A memory is also associated with the controller to store the data of the band, the intervals or limits of operation of the band that are used to determine when to adjust the size of the gastric band, and these intervals or limits of operation (for example, interval limits) can be established before implantation or after adjustment or modified via communications with an external controller / monitor. These and other features of the invention are described in detail in the following description with reference to Figures 1-10. Figure 1 illustrates a self-regulating gastric band system or apparatus 100 as it may appear when installed in a patient being treated for morbid obesity. As shown, the system 100 is being used to form a stoma or smaller opening in the upper portion of the stomach near the esophagus, to restrict food intake and flow. It is often useful or even necessary to vary the size of the stoma to adequately treat a patient. Therefore, the self-regulating gastric band system 100 is adapted for the self-regulation of its size, based on the detected parameters of the band, and the operating parameters (such as a range of operating parameters with the limits upper and lower set). The band system 100gastric includes a gastric band 110 that is inflatable by external or extracorporeal actions via a filling line or tube 112 that is connected to an access gate 114 through which the fluid can be pumped into the inflatable portion or member of the gastric band 110. Such a filler if it is typically performed as part of an initial size adjustment of the stomach as part of the implantation process performed by the physician or other technician. The band 110 and other components of the system 100 are implanted in the same or a similar surgical procedure as used with existing expandable or inflatable gastric bands. For example, a surgeon could typically dissect the tissues around the stomach to create a tunnel for the band 110. The band 110 is then inserted into the abdomen of the patient, for example, through an 18-mm or other size trocar, or the like. , or directly through the trocar hole in the skin. The band 110 is then placed by tunneling in place and placed around the stomach. The other components of the system 100 that include the internal band adjustment system or unit 130 are placed close to the stomach (such as under the skin on the upper part of the sternum or on the sheath of the rectus muscle proximal to the gate. access) with fluid connection provided via the fill / drain line 120 to the gastric band 110, andparticularly the inflatable or expandable member or portion of the band 110 (additional connections are provided in the embodiments in which the band 110 also includes a local fluid reservoir for use in adjusting the size of the band 110). In other embodiments, the connection 120 is provided to the filling line 112, such that no further connection to the band 110 is required. The self-regulating gastric band system 100 includes an internal band adjustment unit 130, which functions to detect a parameter of the band, such as the fluid pressure in the inflatable or expandable portion or the lumen or in the filling line 112, or a property such as tension / strain on the band or the like, to determine if this detected or monitored property or parameter of the band is within a predefined range of band operation, acceptable, and if not, the size of the gastric band 110 is adjusted. Typically, the size adjustment is achieved via the fill / drain line 120 by the addition or removal of the liquid, such as saline, to or from the band 110, which is explained with reference to Figures 4-10. The system 100 further includes an external monitoring or control device 150 that includes a screen or display element 154 that is used to display the data received via wireless communications 152 with the system orinternal band adjustment unit 130, for displaying data such as the new operational parameters that are to be sent to the internal system 100, or for displaying the historical data or other data associated with the gastric band 110. The external monitoring device 150 it also includes a keyboard or other data entry area 156 to allow an operator to enter data (such as to request data from the internal system 130, to enter a new setting for the gastric band 110, by adjusting the operating interval, or Similary) . The gastric band 110 can take many forms to practice the invention. For example, but not as a limitation, gastric band 110 may be configured in a manner similar to the gastric bands described in U.S. Patent Nos. 5,226,429 and 5,601,604, which are incorporated herein by reference in their entirety. Alternatively, gastric band 110 may include one of the gastric bands available from Inamed Corporation (eg, one of the bands in the LAP-BANDMR family of expandable elastic bands such as 9.75, 10.0, 11.0 cm, VG or AP LAP-BANDs). Other gastric bands from various manufacturers / distributors of bands that could be used for this application include, but are not limited to: the band Obtech (Ethicon), the band AMI, the band Heliogast, the bandMinimize (Pier), and the Cousin Bioband. Figures 2 and 3 illustrate one embodiment of a self-regulating gastric band assembly 200, including an exemplary gastric band 210 that can be used to implement the invention (such as for use as band 110 in system 100). The gastric band assembly 200 includes the gastric band 210 and an internal adjustment system 230, as described with respect to Figure 1, and in more detail with Figures 4-10, which generally includes one or more sensors to detect directly the properties of the band 210, a controller with memory, an internal power supply, and a pump assembly (not shown in Figures 2 and 3 but described with reference to Figures 4-10). The gastric band 210 includes a filling tube or line 212 which is used to provide a fluid connection between an access gate (not shown) and an expandable or inflatable portion or lumen 226 in the band 210. A belt 214 with a surface recessed 215 and a raised portion 218 is provided together with a buckle member 216 to allow initial formation of a loop or circular band of a particular initial size or internal diameter, when band 210 is implanted around a patient's stomach ( for example, to initially adjust the size of the band to 9-11 cm or other diameter useful internal) to provide an initial size of a stoma. To allow additional fine adjustment of the stoma, the gastric band includes an inflatable portion or member that abuts the outer surfaces of the stomach. As shown, the gastric band 210 includes a molded shell or shell 220, an inner ring 222, and an inflatable portion, member or balloon 224 made of an elastic or other material that can be increased in size and subsequently reduced in size . Inflatable member 224 includes an internal lumen 226 for volumes received from the fluid, eg, saline or the like. According to a feature of the invention, the gastric band 210 can be configured to provide a local fluid reservoir for storing the fluid, for expansion or deflation of the inflatable portion 224. In this regard, the inner ring 222, which is typically made of a stiffer material than the inflatable member 224 and is engaged in 321 (such as with adhesive) to the cap 220, includes a lumen or reservoir 323 for storing fluid that can subsequently be pumped into the lumen 226 of the inflatable portion 224 by the internal adjustment system 230. The lumen or reservoir 323 is useful as a fluid store, because the tube or connecting line 238 of the reservoir is provided for the internal band adjusting system 230 (such as a pump (not shown) in system 230).
The fluid withdrawn from the reservoir 323 formed by the inner ring 222 is pumped via the line 340 to the internal band adjusting system 230 to the lumen 226 of the inflatable member 224, to increase the size of the gastric band (e.g. external diameter of a cross section of the band 210 as shown in Figure 3) or to reduce the size of the internal diameter formed by the band around the stomach, to reduce the size of the stoma formed in a patient. At other times, the internal adjustment system 230 is operated (based on the detected parameters of the band) to pump fluid from the lumen 226. as shown by arrow 350 via the fill / drain line 234 connecting the lumen. 226 of the inflatable portion 224 to the internal band adjustment system 230 (or to a pump in the system 230). Such removal of the fluid from the lumen 226 decreases the size of the band 210 and the inflatable member 224, while increasing the internal diameter formed by the band 210 around the stomach, and increasing the size of the patient's stoma. The fluid withdrawn from the inflatable portion 224 is pumped into the reservoir 323 as shown by the arrow 340 for storage, and the subsequent use in size adjustment or adjustment of the gastric band 210. Figure 4 illustrates a block shape function of an exemplary assembly or system 400 of gastric bandadjustable The system 400 includes an external monitoring and / or control device 410, which communicates wirelessly 426 with an internal band adjustment system 430. In use, the internal band adjusting system 430 is implanted together with an expandable or adjustable gastric band 460, in an abdominal cavity of a patient, to form a stoma in the patient's stomach, to treat obesity, for example, the gastric band is inflated or deflated by the addition or withdrawal of fluid to change the size of the gastric band and the internal diameter of the band, IDBAD, formed by the band in its circular configuration. The external monitoring and control device 410 may take the form of a computer and / or manual communication device, such as a laptop or desktop that includes a screen or monitor element 412 to display the information, a input / output component 414 to allow a user to enter data or information such as a keyboard, touch screen and / or voice data input feature and for wireless communications as shown in 426 with an I / O component of the internal system 430 band adjustment. The device 410 further includes the memory 416 for storing data 418 of the band, such as those which can be read from the system 430 and provided by the controller 432 and the I / O 434 of the internal system 430 and forstoring band settings 420, such as the ranges or limits of operation (eg, an upper or lower limit such as for a pressure range) for the gastric band 460 which can be introduced with the control device 410 or present in the internal system 430, and subsequently read by external device 410 for storage in memory 416 and / or for modification or alteration by the operation of external control device 410. Memory 416 may also be used by external control device 410 for storing sensor data 422 (and, in some cases, patient data) obtained by the sensor 450 of the internal band adjusting system 430. The internal band adjustment system 430 is shown to include a controller 432, which may include a Central Processing Unit (CPU) and the code useful for controlling the operation of the 430 system. The system also includes a I / O element 434 for communicating with the external monitoring and control device 410. The memory 436 is provided in the system 430 for storing band settings 438, eg, an acceptable range of operation for a particular property or parameter of the band gastric 460, which is detected by the sensor 450 such as a higher and lower pressure limit (eg, 0.28-0.35 kg / cm2 (4and 5 PSI respectively) when the sensor 450 is a pressure sensor for the fluid in the inflatable portion of the gastric band 460. The band settings 438 can be established for the particular patient or as default settings prior to the implantation of the system 430 in a patient and / or band adjustments 438 can be established or modified after implantation via the external monitoring / control device 410, to thereby alter the size of the gastric band 460 and the resulting internal diameter, IDBAND- memory 436 may also be used by controller 432 to store other sensor and band data 440, such as data collected from sensor 450, to provide a historical perspective of operation of gastric band 460 and band information such as the serial number of the band, the manufacturer and the like. To monitor the operation of the gastric band 460, the system 430 includes the sensor 450 which preferably directly monitors the properties or physical parameters of the gastric band 460. As shown, the sensor 450 can be provided on or connected to, as shows at 452, a pressure transducer or other device in a fluid connection or connection 448 between gastric band 460 and pump assembly 442 of system 430. Alternatively, a pressure transducer or other pressure sensing devicecan be provided as sensor 450 or in communication with sensor 450, for measuring pressure in gastric band 460 such as by placing in the inflatable portion of band 460, in an inlet gate to band 460, in line of filling 478 which is in communication with the access gate 474 and the external filling device 470 (which, in turn, is provided for the initial filling of the inflatable or expandable portion of the 460 band, or for optional adjustment later of band 460). The sensor 450 may also be positioned to otherwise detect directly the properties of the band 460, as shown by line 456, for example, with a voltage sensor indicating the surface tension of the band 460, such as on a surface of the inflatable or expandable portion, or with other sensing devices useful with measuring the current size of the gastric band 460. The sensor 450 may include the memory 436 or the memory for storing the band settings 438, such that when the latter detecting a parameter of the band 460 that is outside a preset range (as previously described a maximum setting or below a minimum setting) the sensor 450 can "wake up" the controller 432 to operate the pump assembly 442. In other words, the sensor 450 can be configured to be smart enough to determine when the gastric band 460 isoutside of a preset operating range, and responding by alert or alarm, to cause the controller 432 to operate to control the pump 442, include the transmission of the detected band parameter, to allow the controller 432 to act appropriately to adjust the band 460. Alternatively, the sensor 450 may be periodically (or, in some cases, more frequently to approximate near continuity) operate the sensor 450 to take an additional reading of the property or parameter of the band (as shown in 452 and 456) and to provide detected controller 432 which, in turn, acts to compare the detected value of the band with the settings of band 438, to determine whether the settings of band 460 are required or desired. In any case, a power supply 444 such as a battery or the like is used to power the controller 432 and other power consuming components of the system 430 (such as pump assembly 442 and sensor 450). The system 430 further includes the pump assembly 442 and an internal reservoir 446. The pump assembly 442 can take a variety of forms (such as those shown in Figures 5-10) to hydraulically adjust the size of the 460 band in response to the sensor information 450, and the invention is not limited to a particular pump or fluid transfer device. The internal deposit orlocal 446 is in fluid communication with pump assembly 442 and provides fluid (such as saline) for pumping via fill / drain line 448 within band 460, to increase its size and reduce IDBAND and also provides a site for storing fluid that is pumped or allowed based on the pressure differentials from band 460 via line 448 and pump assembly 442. Tank 446 may be provided as a separate component in a housing (not shown) that is used to enclose or encapsulate the internal band adjusting system 430 or the reservoir 446 may be provided as a separate device, such as in the form of a balloon-like structure, which is provided proximate to the housing of the system 430, and band 460. In addition, in some embodiments, reservoir 446 may be provided as part of gastric band 460 itself, such as in a lumen or external member of the gastric band. band sleeper (as shown in Figures 2-3 and Figure 5-10). With an understanding of the general characteristics of self-regulating gastric band systems, it may now be useful to discuss more fully the operation of such systems to effectively adjust the size of an implanted gastric band (such as bands 110, 210 and 460). The pump assembly is typically modular, and can be used with any of a number of bandsgastric, for example, those currently available from Inamed Corporation such as 9.75 cm, 10.0 cm, VGs or APs LAP-BANDs. The pump in the pump assembly replaces the function of the manually adjustable access gate. The materials used to build the band will generally remain the same as those normally used, and the dimensions of the band, except the pipe in the case of a local deposit that is provided in the bushing or pipe, will remain the same . However, alternative materials may be used to implement the invention, such as materials selected specifically to improve performance, to increase acid resistance, or to achieve some other desired result. Similarly, there may be a minor change to the band tubing, to increase the external diameter from 0.130 to 0.180 or greater, to increase saline capacity in the external lumen or bushing or tubing, to act as a reservoir for saline solution or additional fluid that can be used for future adjustments. The gastric band tubing can have 2 lumens to separate the saline, for the reservoir, and the saline that is part of the band (as shown in Figures 2 and 3). In addition, a long extended balloon can be placed along the pipeline to act as a reservoir. The pump assembly will generally include one ormore pumps (or pump-like devices to move fluid in and out of the band, electronic components, communication components, computer or intelligence components, and a power supply such as a battery or batteries.) The internal adjustment assembly gastric band will be sealed inside an external housing made of a biocompatible material such as acetyl copolymer, PEEK, titanium or the like In some embodiments, the power supply is an implantable grade battery that is hermetically sealed in titanium before being placed Within the pump assembly, the pump assembly may have an overlap gate that will allow manual adjustments if necessary, such as with the external filling device 470 via the access gate 474 shown in Figure 4. In some preferred embodiments, The self-regulating gastric band system works automatically or as a "put and forget" device For example, the system can operate continuously or periodically (such as hourly, daily, weekly, monthly, or some other monitoring period selected) to detect a parameter or property of the band, and then adjust this one as by inflation or deflation of the gastric band, hydraulically with saline or other fluid. In some cases, an equal or similar specification for the saline fill volume and a burstThe filling of the band will apply to the self-regulating gastric band system. The adjustments in these self-regulation modes are made by the remote activation of a micropump or pumps coupled with the sensor and with electronic control components. The sensor directly detects a parameter or property of the band such as an internal parameter of the band, for example, an internal pressure of the band, or an internal or external parameter, such as the stress and / or tension of the bushing. The sensor may also include a linear motion sensor that detects changes in length in the band or in the inflatable portion of the band, with the sensor or controller acting to convert this detected length delta to measurements of stoma diameter or from the band. The sensor can also be a distance sensor that works to detect the distance between two points to detect a change in position. The sensor could be scrutinized or inspected by an external monitoring or control unit via telemetry to obtain data on the parameter that is monitored for real-time feedback to the clinician. In some cases, the sensor is programmed to "wake up" at intervals (or monitoring periods) to monitor the parameters and to adjust the band to the or the ideal band parameters established through the test, or set to better treat a patient in alonger treatment period. If the parameters are not within the ideal range, the sensor will send a command for readjustment, as necessary, to ensure that the band readings are within the ideal control limits of the parameters or alternatively the sensor will merely pass on the information obtained from the band to the controller, for use in determining whether or not the band is in a desired operating range. For example, the sensor can "wake up" and determine that the band is monitoring an internal band pressure of "X kg / cm2 or psi" and determine, based on a comparison with the preset band parameters, that the band needs to be adjusted such that its internal fluid pressure is "Y kg / cm2 or psi" which may be a pressure at the intermediate point within an operating range or any pressure within that range. The sensor, in this arrangement, will communicate with the controller to cause the controller to activate the implanted pump and command the volume of fluid to be pumped in the band or out of the band, until the sensor reads within the limits of the ideal parameters, for example, by the operation of the pump until the sensor detects an internal fluid pressure to the band within the range or equal to the intermediate point of the current operating range (or another reset point stored in the memory , associated withsensor or with the controller). The micropump or pumps draw energy from the implanted battery or power supply to allow adjustment and, if included, the controller also activates one or more check valves to open (see Figures 5-10). To inflate the band additionally or to increase its size finely, the pump draws fluid from the local reservoir into the band. To deflate the band or to finely reduce its size, the pump will draw fluid from the band back into the reservoir. Once the sensor reads within the specified range of parameters, the valve will close to prevent fluid migration. The pump and sensor will then turn off to conserve power until the sensor "wakes up" again. Just as in the current bands, the fluid will be used either to inflate or deflate the cap, to control the size of the stoma but in this case the change in size is handled internally using local control and a local fluid reservoir. After the parameter monitored by the sensor has been changed, the sensor will send a command or message to the controller to record the date on which the parameter was changed, the value of the new adjustment or the detected parameter or property of the band, and in some cases, the delta or amount of the change. To externally monitor a reading ofparameter such as a new or adjusted parameter reading from the sensor, a clinician or system operator can use a manual or other external monitor and the control device external to the patient's body to find out the sensor for a reading, and for Find out the driver for a most recently stored value (or both). Apart from the external monitor device and the access gate, the system is self-contained to monitor and adjust for itself. The pump assembly can store a variety of data in addition to the band data and the acceptable band operating range such as a serial number that can be remotely read by external monitoring and control devices, to identify the implanted device including the implanted gastric band and the internal adjustment system of the gastric band. The external device will often take the form of a manual control unit that can characterize an LCD screen and the control panel to operate the device. The manual control can characterize a series of menus that allow an operator to program (or read / determine) the implant to contain important information in the memory such as the size of the band, the name of the patient, the implanting physician, and the date it is implanted. The handheld device can communicate with the sensor via telemetry through radio waves. The FDA andglobally recognized communication bands (MTS 402-405 Mhz) can be used in some modes, and an authentication process can be used to ensure that the device can not be accidentally accessed or controlled by any other control mechanism than the manual. The telemetry control signal may be sent from approximately 30 cm or possibly a greater distance from the patient, and typically will not require the patient to undress to inquire or figure out the sensor or to change its parameters. During adjustments, the external manual monitoring device is preferably able to read and describe information to the implant such as current pressure data or parametric data, adjusting the doctor's name, the date with the manual device that often operates to store or keep the history of settings in its own memory (this story can be stored in the internal adjustment system, also or only). The handheld device can also be controlled by a keyword to prevent unauthorized personnel from investigating the device. The screen of the handheld device that can include visual and audio outputs, will typically show or output the detected parameter of the band affectation or the physical parameter, if this parameter or property is the pressure, voltage, effort and / or linear measurement.
Regarding the duration of the sensor change, the sensor inquiry will typically take only a few seconds, but the control of the micropump (s) may take longer, such as approximately 30 seconds per 0.0703 kg / cm2 (1 psi) of change of pressure. The resolution of the pressure readings and the parametric ranges will be fine and preferably have higher resolution than what is currently possible by manual syringe settings. Regarding data storage, at least a portion of the information will be stored directly on the internal system implanted. To retrieve data, the handheld device can be used to investigate the device and visually display the data, such as the serial number, the patient's name, the name of the doctor, the size of the band, or the volume of the patient. filled, and the history of adjustments. Regarding the energy source of the implant system, although the foregoing specifically mentions an implanted battery, the implant could be energized by a variety of internal energy sources that meet the energy requirements such as the following: (a) creation of energy kinetics by the body movement stored on a capacitor; (b) an implanted fuel cell; (c) an implanted energy source energized by body chemistry; (d) a source of energyimplanted energized by the temperature change; and (e) implanted batteries that can be recharged by direct contact. The manual control device will typically be powered by rechargeable batteries while some modes may use other sources of energy. For example, a power cord may be provided to allow recharging the device between uses, with most modes with a fully charged device operating a daily check value of a plurality of implanted band systems. The self-regulating gastric band adjustment system of the present invention has a number of design advantages. For example, the system provides accurate or safe operation, and supports telemetric communication with the implant. The system is configured to reduce the risk of infections and to improve patient comfort. The implantable battery or power source provides a reliable and consistent power supply. The system can be operated to provide feedback on the state of the implant, which can be used to improve therapeutic intervention and patient follow-up. In some embodiments, the external monitoring and control device, such as device 410 of Figure 4, is configured to control the operation of the systeminternal band adjustment. In these embodiments, sensor 450 (or controller 432) is interrogated by external device 410 via telemetry 426, to obtain data on the parameter that is monitored by the sensor at 452 and / or 456. Based on current readings , the clinician or operator of the device 410 that is obtaining this information can then change the monitoring limits (e.g., the band settings 438 that can be programmed in the sensor 450, when the sensor 450 is configured to intelligently monitor the operating limits of band 460) of the parameter, such as to increase or decrease the pressure or tension and effort of the gastric band. The sensor 450 (or the controller 432 by storage of the new band settings 438) can then be reprogrammed to read data and determine whether the new data is within the modified control limits. The sensor 450 sends a signal to the control mechanism 432 to adjust the band 460 such that (or until) the sensor 450 reads the data (e.g., a property or parameter of the gastric band) within the control limits (or band settings 420 or 438). For example, a band may be monitoring or reading a band parameter (such as fluid pressure within band 460) between 0.14 and 0.21 kg / cm2 (2 and 3 psi) when the clinician investigates the sensor 450 by operation of theexternal device 410. The clinician, physician or other operator may then choose to increase the range of band monitoring to a range that has 0.35 kg / cm2 (5 psi) as its intermediate point. The physician will reprogram the sensor 450 to monitor between 0.31 to 0.38 kg / cm2 (4.5 to 5.5 psi) (such as by readjusting the band settings 420 and / or 438) and send these to the sensor 450 telemetrically 426. The sensor 450 it resets its monitoring limits (or the controller 432 resets the band settings 438 for use in the comparison of the band parameters obtained by the sensor) and communicates with the controller 432 to activate the implanted pump assembly 442 such that a Fluid volume is pumped into the band or out of the band until the sensor 450 reads (via 452, 456) within the control limits. During operation, the pump draws energy from the implanted battery or power supply 444, to allow adjustment and also activates any check valves to open (as discussed with reference to Figures 5-10). To inflate the band 460, the pump assembly 442 draws fluid from the reservoir 446 toward the band 460. To deflate the band 460, the pump assembly 442 pulls the fluid from the band 460 back into the reservoir 446. Once the sensor 450 reads within the specified parametric range, the appropriate check valves areclosed to prevent fluid migration from or to the band 460. To confirm the new pressure reading (or other band parameter) the physician or operator uses the handheld device 410 to inquire the sensor 450 for another reading. If confirmed, pump assembly 442 and sensor 450 are turned off until they are re-investigated to conserve energy. Figures 5-10 illustrate particular self-regulating gastric band systems, which may be employed to practice the invention. Each system described that provides an alternative example of an effective pump assembly can be employed in a gastric band system (such as for the pump assemblies of the internal band systems of Figures 1-4). The described systems each employ a pressure sensor for use in the detection or determination of fluid pressure in the inflatable or expandable portion of the gastric band (hereinafter labeled "internal expandable ring"). However, it should be remembered that the invention is not limited solely to a pressure sensor and that many embodiments of the invention(including those described in Figures 5-10 with a sensor replacement) employ other sensors to directly detect one or more properties of the gastric band or physical parameters. For example, but not as a limitation, theUsed sensors may include: 1. Pressure Sensors, such as those available from CardioMems and Tronics Microsystem, S.A .; 2. Implantable-grade stress-strain sensors, for example, those available from CardioMems and Tronics Microsystem, S.A., or that are developed by these companies individually or in joint efforts with Inamed (the assignee of this patent application); 3. Linear motion sensors, such as those available from Microstrain, Inc. (for example, see http://www.microstrain.com/images/sensorman.jpg, which is incorporated by reference herein); 4. Distance sensors, such as those distributed by Microstrain, Inc., to measure the distance between two points; 5. Force sensors, such as those distributed by Microstrain, Inc., to measure the force exerted against an area by the saline solution; 6. Thermal sensors, such as those available or in development by Verichip or by Verichip eInamed (the assignee of this patent application), to measure a thermal gradient from a low level heat source, at an approximate distance; and 7. The thickness gauge of the protection or bushing, to detect the reduction in the thickness of theCap wall due to elongation during expansion. With reference to Figure 5, a scheme of a self-regulating gastric band system 500, including a gastric band 510 for implantation in a patient, in a circular configuration around its stomach to form a stoma is illustrated. The band 510 includes an outer ring reservoir 512 for storing fluid for use in adjusting the size of the band 510, for example, a lumen may be provided in the outer ring or bushing of the band extending at least partially around of the circumference of the band 510 (or along the length of the band when it is not implanted or placed in its circular configuration, such as from a head to a tail of the band or from a first end to a second end of the band. band) . An expandable or inflatable inner ring 514 is provided in the band 510, which is formed of a material that allows it to expand as it receives a fluid and deflates or contracts when the fluid is withdrawn or drained. As discussed above, expandable gastric bands are well known in the art, and almost any of these known bands can be employed in system 500 with modifications to include the outer ring reservoir 512 and a fluid connection line 517(or a line or tube for filling / draining the reservoir) provided to the reservoir 512. During use, the inner expandable ring 514 is filled and drained of fluid via a line or filling tube 516 (which can be considered more precisely as a line for adjusting the size of the band). Adjustment of the initial size of the band 510 is performed via the access or manual gate 518 which is typically implanted just below the skin of the patient, and which is connected to the filling line 516. Size adjustment includes injection of a volume of fluid by the clinician, which is typically selected for gastric band 510, in an attempt to obtain a desired internal diameter of the band 510. Fine tuning and progressive "self-regulation" is performed in the system 500 using an internal band adjustment system constituted in a pump assembly 530, a sensor 522, a power supply 528 (e.g., one or more batteries) and the control and communication components. Although not shown, the system 500 can interact with an external monitoring / control device as discussed in detail above. In this regard, an antenna or other wireless communication component 524 is provided in the internal assembly or linked to the control 526, and this antenna 524 allows the telemetry to be used to communicate the band parameters and other information (again, asdiscussed in detail above) with the external monitoring / control device. As illustrated, a housing 520 is provided such that the components of the internal band adjustment system can be isolated within the patient. Within the housing 520, a pump assembly 530 is provided together with the sensor 522, the antenna 524, a control 526, a battery or power source 528 ^ and the memory 529 (which can be incorporated in the sensor 522 and / or control 526). The sensor 522, the control 526, the battery 528 and the memory 529 provide the functionalities described in detail with reference to Figure 4, and the preceding description. In this embodiment, the sensor 522 is a pressure sensor for detecting the fluid pressure in the inner expandable ring 514. For this purpose, the filling line 516 is routed to the housing 520 from the manual port or gate 518, through or by means of contact with the sensor 522 towards the entrance of the inner expandable ring 514. In some embodiments, the sensor 522 includes a pressure transducer that can directly detect the back pressure applied by the fluid in the inner expandable ring 514 on the fluid in the filling line 516. In other embodiments, the sensor 522 or a portion of the sensor 522 is provided in the band 510, such as in or near the entrance gate to the internal expandable ring 514 for the filling line 516 orlower than inner expandable ring 514. Sensor 522 may be inactive for periods and activated by control 526, by an internal synchronization mechanism, and / or by an external monitoring device. Sensor 522 when activated takes pressure readings and provides these to control 526 for storage in memory 529 and / or for comparison against a preset operating interval (e.g., minimum and maximum pressure limits or boundaries such as 0.21 a 0.49 kg / cm2 (3 to 7 psi) or more likely 0.28 to 0.35 kg / cm2 (4 to 5 psi), which may be considered as band adjustments) stored in memory 529. Alternatively, sensor 522 may have intelligence and memory, and act to compare the read pressure readings (e.g., the band property directly obtained) to the band settings programmed in the sensor 522. When the pressure read in the band 510 is outside the band settings, the sensor 522 can wake the controller 526 to operate, to raise or lower the pressure in the band 510 by operation of the pump assembly 530, to add or remove fluid from the internal expandable ring 514. The battery 528 provides a local power source for the energy-containing components within housing 520, such as control 526, sensor 522, and any pumps and / or electronic valvesin the pump assembly 530. In addition to the band settings, the memory 529 can perform pressure readings from the sensor 522 and other data related to the gastric band 510 (such as the band identification information, the implantation date , and the like) as well as, in some cases, the data related to the patient (such as the name of the patient, the date / time of the last treatment, and the like). The pump assembly 530 functions in general to respond to the control signals from the control 526 either to pump fluid to the inner expandable ring 514 or to remove or remove fluid from the inner expandable ring 514 to adjust the size of the band. 510, whereby a parameter or band property monitored by the sensor 522 is returned within an operating range or within the band settings. As shown, the pump assembly 530 of the system 500 includes a relief valve 532 (e.g., a ceramic relief valve or the like operated by a spring plunger) in fluid communication with the outer ring tank 512 via the line 517. Relief valve 532 is operated by a 534 pump (for example, a Bartel actuator pump of 0.49 kg / cm2 (7 psi) or another pump having the same capacity or a greater or lesser capacity or higher pressure ratio or minor) that is prepared with an internal deposit 536.relief valve 532 is also shown connected to fill / drain line 516 of inner expandable ring 514. Relief valve 532 is provided to allow pump assembly 530 to equalize the pressure between external ring reservoir 512 and ring internal expandable 514, which may be desirable in some embodiments (and when not, these components associated with relief valve 532 may be omitted from pump assembly 530). In addition (or alternatively), the relief valve532 can be used to drain / remove fluid from the inner expandable ring 514. In these embodiments, the sensor 522 can detect a pressure that is too high, for example, above an upper limit of a band setting or operating range. , and control 526 can respond to a signal from sensor 522 to activate pump 534 to open relief valve 532. A pressure differential between external ring reservoir 512 and internal expandable ring 514 results in fluid flow from the inner ring 514 via the filling line 516 and the relief valve 532 to the outer ring reservoir 512 (for example, this operational mode assumes that the fluid reservoir 514 is maintained at a lower pressure than the fluid in the ring internal expandable 512). The 522 sensor continues to monitor the pressure in the ringinternal expandable 512 and when it (or control 526) determines that the pressure is within the desired operating range (or more typically at or near the center or intermediate point of such range) the control 526 is operated to deactivate the pump 534 for turn off the relief valve 532. The pump assembly 530 of the system 500 also includes a pair of check valve 542, 546 (for example, Bartel check valves or the like) between which a pump 540 is placed (for example , a Bartel actuator pump of customary 1.4 kg / cm2 (20 psi), or similar). A check valve 542 is connected to the outer ring reservoir 512 via the line 517, and a check valve 546 is connected to the internal expandable ring 514 by means of the filling line 516. The pump 540 is connected between the check valves 542, 546 with the flow during pumping that is coming from the outer ring reservoir 512 towards the inner expandable ring 514. With this arrangement, the pump 540 can be used to increase the size of the band 510 when it is operated by the 526 control for pumping fluid from the outer ring reservoir 512 through the check valves 542, 546 in the inner expandable ring 514. The control 526 provides a shutdown signal when the fluid pressure in the inner expandable ring 514 iswithin the established operating range (or at or near an intermediate point or other preset point within such range) as determined by the operation of the sensor 522 and the control 526. In some cases, the band 510 may be adjusted to having a smaller size by removal of the fluid from the inner expandable ring 514 via the pump 540. In these embodiments, the sensor 522 can detect a pressure that is too low (eg, less than a lower limit of the operating range or parameters band) and provide this information to control 526. Control 526 then signals check valves 542, 546 to open, and fluid is allowed to flow back through pump 540 to the outer ring reservoir 512 via line 517. This embodiment also assumes that the pressure of the outer ring reservoir 512 is less than that of the fluid in the inner expandable ring 514, and that the pump 540 is It is configured to allow backflow when it is not actively pumping. When the sensor 522 detects a pressure within the programmed operating range (or an intermediate point or other set point within that range) as determined by the sensor 522 and / or the 526 control, the 526 control operates to close the valves retention 542, 546. Figure 6 illustrates a physical arrangement for thepump assembly 530. As shown, housing 520 is a one-piece unit or enclosure that encloses sensor 522, control 526, battery 528, pumps 534, 540, and internal reservoir 536 (as well as other components of pump assembly 530). The housing also provides fluid gates or connection points for the fill line 516 and the tank connection line 517. The materials used for housing 520 are preferably biocompatible, and housing 520 is preferably constructed to be leak resistant (eg, "watertight" to water or fluid) to withstand prolonged use of the pump assembly as an implant. In other embodiments not shown, the housing 520 can take different forms such as a cylinder, a square, or other useful shape and can be modular such that different components are provided in two or more housings which can be coupled or provided as uncoupled modules. Figure 7 illustrates a scheme of another embodiment of a self-regulating gastric band system 700. The system 700 is configured in a manner similar to that of the system 500 with an adjustable gastric band 510 having an internal expandable ring 514 and an external ring reservoir 516, with the fill / drain lines 516 and 518, respectively. An access gate 518 is connectedto the fill / drain line 516 to allow external filling of the inner expandable ring 514 with saline or other fluid, such as during the implantation process, to initially adjust the size of the band 510. In a housing 720, a sensor 722 is provided in the fill / drain line 516 for detecting the gas pressure of the gastric band 510 in the inner expandable ring 514. An antenna 724, a control 726, a battery 728, and memory 729 are provided with similar functionality to that of similar components in system 500. System 700 differs from system 500 in the configuration of pump assembly 730 provided as part of the internal band adjustment system in housing 720. As shown, pump assembly 730 includes a vent valve 732 connected to the fill / drain line 516, 517 which is operated in a manner similar to valve 532 by the operation of pump 734 and the reservoir 736 and control 726. However, pump assembly 730 differs from pump assembly 530 with the replacement of a single pump 540 with a plurality of pumps 740, 742, 744(for example, three Bartel actuator pumps of 0.49 kg / cm2 (7 psi) or another pump useful for this function / purpose) that are arranged in series between the check valves746, 748. The pumps 740, 742, 744 are operated by means of the battery 728 and the control 726 to pump fluid from theexternal ring reservoir 512 towards the inner expandable ring 514, when the sensor 722 detects a pressure less than a preset lower pressure limit. In addition, in some embodiments, check valves 746, 748 are opened by control 726 and energized by battery 728, to allow fluid in the internal expandable ring that is under a pressure above a current upper pressure limit. (as detected by the sensor 722) flows out of the inner expandable ring 514 through the pumps 740, 742, 744 towards the outer ring reservoir 512 until it is determined by the sensor 722 and the control 726 that is within the range of preset operation. Figure 8 illustrates one embodiment of a self-regulating gastric band 800 system that is similar to systems 500 and 700 that include an expandable gastric band 510 with a self-contained fluid reservoir 512, and within the housing 820 a self-contained gas sensor. pressure 822, a communication module 824, a controller 826, a local power supply 828 and the memory 829. The system 800 nevertheless includes a pump assembly 830 in the housing 820 which differs from the pump assemblies 530, 730. As shown, an optional relief valve 832 is provided between the outer ring reservoir and the internal expandable ring 514, which is operable to maintain a desired pressure differential between the fluid in these two portions of the band.510 (or the 800 system). For example, it may be desirable in some bands 510 to maintain a differential smaller than about 0.14 kg / cm2 (2 psi) or less than about 0.017 to 0.0703 kg / cm2 (0.25 to 1 psi) or similar. In other embodiments (not shown) of system 800, vent valve 832 may be emitted. To allow for selective adjustment of the size of inner expandable ring 514, pump assembly 830 includes a pair of check valves 846, 848 connected to the fill / drain lines 516, 517. The pumping or driving forces of the fluid are provided by a syringe or other chamber 842 that is in fluid communication with the two check valves 516, 517 and therefore, with the two reservoirs or prtions 512, 514 of the band 510. The fluid is pulled in and forced out of the chamber 842 by the operation of a SQUIGGLE motor 838 which is sealed in a motor housing 834 having a bellows 836 to support the movement of a column / piston 840 connected to the engine 838 (for example, a SQUIGGLE engine or the like) and the chamber 842. During operation of the system 800, the sensor 822 senses the pressure in the internal expandable ring 514 of the ba 510. The detected or monitored band prty is either used by sensor 822 to determine if the band pressure is within an operating range.programmed or preset, or such a determination is made by control 826. Once the determination is made that the pressure is less than a pre-set lower limit or outside the low range, control 826 operates motor 838 to pump fluid from the outer ring reservoir 512 towards the inner expandable ring 514 by means of the check valves 846, 848 and the fill / drain lines 516, 517 until the pressure in the band 510 which is detected by the sensor 822 is within the preset operating interval (or typically some amount higher than the lower limit). When a determination is made that the fluid pressure in the inner expandable ring 514 is higher than a pre-set upper limit or outside the high range, the control 826 can adjust the pressure (and the corresponding size of the ring 514) by opening the the check valves 846 and 848, to allow the fluid at a higher pressure in the inner expandable ring 514 to flow to the outer ring tank 512 via the fill / drain lines 516, 517 until the pressure detected by the sensor 822 is again within the range (or at a preset amount or pressure below the upper pressure limit). Figure 9 illustrates another self-regulating gastric band system 900, similar to systems 500, 700 and800, since it includes a gastric band 510 and a housing 920 that encloses a pressure sensor 922 in the filling line 516 of the band 510, an antenna or communication element 924, a control device 926, a battery 928, and the memory 929. The pump assembly 930 is similar to the assembly 830 in that it includes a relief valve 932 in fluid communication with the internal expandable ring 514 and the outer ring reservoir 514 via the lines 516, 517 to maintain a differential of desired pressure between the two lumens or reservoirs 512, 514. The pump assembly 930 differs from the mounting 830 with respect to the insertion between the check valves 942, 946 of a pump mechanism which is constituted by a motor housing 934 which seals a SQUIGGLE 940 motor that is used to drive or move a 938 diaphragm by means of an axle or column extending through or inside the 936 bellows. Other operations of the 900 system are similar to aq System 800. Figure 10 illustrates a self-regulating gastric band assembly 1000 that is similarly configured to system 500 of Figure 5. Differences between systems (or unique aspects of system 1000) include positioning of the sensor 1022 external to the housing 1020 between the inner expandable ring 514 and a check valve 1049 in the filling line 516. The sensor 1022 is in communication (wired or wireless) with thecontroller 1026, which acts to communicate with an external monitoring / control device (not shown in Figure 10) via the antenna or communication element 1024, to store the data received from the sensor 1022 and the external monitoring / control device in memory 1029, and to energize pump assembly 1030 (as necessary) with battery 1028, which also energizes controller 1026. Controller 1026 is also configured to operate (as discussed in detail below) the pump 1030 for automatically maintaining the band 510 within a desired operating range typically defined by a lower limit and an upper limit (e.g., a lower pressure limit and a higher pressure limit) by pumping fluid in and out of the inner expandable ring 514, based on the band properties detected by the 1022 sensor (e.g., the fluid pressure in line 516 and in the ring 514). The system 1000 also differs from the system 500 in the configuration of its pump assembly 1030. The pump assembly 1030 includes a relief valve 1032 for venting the higher pressure fluid in the inner expandable ring 514 (when detected by the sensor and based on the control signals from the control 1026) to the inner ring reservoir 512. The assembly 1030 however includes a different pump 1034, forexample, a Thinxxs pump of 0.35 kg / cm2 (5 psi) or similar, than that used in the system 530, which is set by the reservoir 1036 to operate the relief valve 1032 in response to the signals from the 1026 control. system 1000 also differs from the system 500 in that a plurality of pumps 1040, 1042, 1044, 1046 (for example, Thinxxs pumps of 0.35 kg / cm2 (5 psi) or other useful pumps) are placed between check valves 1048, 1049 and the reservoir 512 and the inner expandable ring 514, instead of a single pump 540. These pumps arranged in series 1040, 1042, 1044, 1046 are operated to pump fluid from the reservoir within the inner expandable ring 514, when the sensor 1022 detects a pressure less than (or outside of) a minimum pressure that defines a lower limit of the desired operating range or the programmed pressure range for the band 510. As can be seen from Figures 5-10, there are many config Different pump assembly urations, which may be used to implement the present invention. In addition, other components can be varied to achieve the desired functionality of a self-regulating gastric band. For example, the systems shown in Figures 5-10 include a fluid reservoir provided in a lumen or integral portion of the gastric band. In some modalities, it may be desirable to havethe fluid reservoir provided inside the pump housing. In other cases, the fluid reservoir may be provided as an external component to the pump housing and external to the gastric band, such as by the provision of a separate elastic bag, balloon or other similar structure that could be useful for storing fluid for pumping inside the band and out of the band by the pump assembly. In some embodiments, it is desirable to allow adjustment of a band implanted by a physician or other technician via a telephone connection. In summary, this is achieved by providing a local controller to the patient and a local remote controller to the doctor or technician, with the two controllers communicating by means of a wired and / or wireless telephone connection. It can be thought that the local controller is a remotely adjustable manual band controller (RAB) (or the controller can be fixed but local to the patient) or The main function of the is to locate the implanted pump, to control the implanted pump, to provide facility to use the programming and system status screen, to allow access to the functions through a remote dial, to provide an application of network server that allows control based on the network page of all functions when accessed through remote dialing, andprovide a standard wireless connection to a cradle or fork, which provides power to the controller and a telephone connection (to access the network page and / or another controller). The local controller or may, for example, be used to communicate via the antennas of the systems shown in Figures 1-10, and the use of such an RCH is explained in more detail in the following description. Figure 11 illustrates in the form of a functional block a gastric band system 1100 using a RAB controller 1150 to control the settings of an implanted (or implantable) band 1190. Figure 12 illustrates the RAB controller 1150 and its yoke or support 1110. more details. As shown, the system 1100 includes a support 1100 for providing telephone connections and power for a manual controller RAB or 1150. The 1150 in turn is used for control via the data transferred over the wireless connection 1162 of an implanted pump 1170, which adjusts or regulates the size of a gastric band 1190 by controlling the transfer of fluid over the connection 1179. The fluid is supplied in this example by the external reservoir 1180 (eg, external to a housing of the pump assembly 1170 or via a manual gate 1184 (for example, for an initial fill or size adjustment of the band 1190) by means of connections 1181, 1185. Aswith the previously described pump assemblies, the pump assembly 1170 includes the telemetry circuitry 1172, the controller and the memory 1174 and one or more hydraulic pumps 1178. It is shown that the RHC 1150 includes a user interface 1152 and the screen 1154 together with a keyboard (or user input mechanism) 1164 to allow a user (such as the gastric band patient or another operator of the 1100 system) to observe the data from the pump assembly 1170 and the remotely received data via telephone connection 1118, and to allow the user to make adjustments and enter data in some cases. The RHC 1150 further includes a controller 1156 of the system, a set of wireless circuits and the antenna or support connection 1158 for communicating with the carrier 1110, an implant telemetry 1160 for communicating with the telemetry circuitry 1172 of the antenna assembly. implanted pump 1170, and a power supply / battery 1168 to allow the RHC 1150 to be used outside the support 1110. The support 1110 provides a power connection 1128 by providing an energy connection 115 to a power supply 1104 via the power supply 1120 and the RHC charger 1126. More significantly, the support 1110 includes a controller 1111 and a connection oftelephony / data 1118, to facilitate remote control of the RHC 1150 and pump assembly 1170 via a telephone jack or other connection 110 which is connected 1103 to a line interconnection 1112 to communicate with the RHC 1150 via the wireless communication circuit / 1114 antenna. The main functions of the RHC 1110 support are: charging the RHC 1168 battery, storing the RHC 1150 when not in use, providing telephone / line interconnection including a MODEM (in some cases as shown in Figure 12) ) for data access via interconnection 1112, implement a standard 1118 wireless data connection between the MODEM and the RHC 1150, to allow remote access to the RHC feature and pump assembly 1170, and allow access to the RHC functions through remote dialing. Figures 13 and 14 illustrate a useful physical implementation of the RHC 1150 and the support 1110. These figures show that the RHC 1150 can be easily removed and inserted or engaged within the support for charging via the power connection (or the coupling connector). 1128. A telephone line 1103 is connected to (or connectable to) the holder 1110 as is a power line 1105 (such as a direct current line of 12 volts). The screen 1154 on which a user connection 1152 could be provided, is shown in the RHC 1150 as akeyboard 1164 and a power on / off switch or button 1356. The RHC 1150 can be configured in a number of ways to include an implant telemetry access antenna and the standard wireless antenna 1156, 1160 with these shown in the Figure 14 to be provided on the back of the body or housing of the RHC 1150 for ease of access and maintenance. As can be seen, the RHC 1150 is configured for facilitated manual operation, to allow a user to place the RHC 1150 close to the patient and the gastric band 1190, to facilitate communications with the 1172 implant telemetry circuitry in the assembly pump 1170, and ease of data entry / exit via screen 1154. It may now be useful to discuss a few of the operational characteristics of the 1100 system and the RHC 1150, along with a discussion of its operations, with reference to Figure 15 , to regulate an implanted gastric band 1190. Useful features in the 1110 system and the RHC 1150 include: (a) the implantable pump 1170 that the RHC 1150 controls, is self-energized and does not require energy to be transferred by the controller 1150; (b) the implantable pump 1170 makes adjustments to the band 1190 until a desired band pressure is reached (as opposed to a desired volume); (c) the RHC 1150 contains a standard 1158 wireless interconnect, such as Bluetooth or ZIGBEE, whichconnects the RHC 1150 to the telephone interconnection 1114 in the RAB support 1110, which in turn is connected via the interconnection 1112 and the connection 1103 to a remote computer or remote controller (not shown), capable of accessing the marking or communication of other data and control information to the RHC 1150; (d) the RHC 1150 contains the networking software run by the controller 1156 that allows connectivity from remote computers through the telephone interconnection provided by the support 1110 and the wireless interconnection 1158; (e) RHC 1150 contains a network server run by system controller 1156 that allows network-based access to all RHC 1150 functions, including setting commands, after a dial-up network connection has been established on the telephone interconnection, which eliminates the need to install specific software of the application on the access computer (for example, in a mode, Secure Internet Explorer or a similar connection is used). The RHC 1150 operates in the following high-level modes: normal, remote accessed, coupled and low-energy. Figure 15 illustrates the operation of the RHC 1150 (or gastric band system 1100) in the normal mode to remotely adjust or remotely regulate a 1500 gastric band ina patient. In this mode the primary function of the RHC is to access and control the implantable pump of RAB 1170. The wireless access to the implantable pump 1170 can be, for example, through the Medical Implant Communications Service (MICS). which is a band operating in the frequency range of 402-405 MHz. The communication protocol between the RHC 1150 and the implantable pump 1170 can be maintained in compliance with patient privacy regulations and industrial health regulations. The flow chart in Figure 15 shows a typical group of activities that lead to an adjustment. Adjustments are typically in the form of pressure changes in the band, as opposed to discrete volumetric changes. In normal regulation mode or process 1500, the RHC 1550 is energized at 1510, such as by pressing a button or moving a switch 1356 over the RHC 1550. In 1520, a keyword entry may be required to use the RHC 1550, to prevent unauthorized users from adjusting the band 1190. At 1530, the RHC 1550 is operated by the system controller 1156 to search and find the implanted pump 1170 such as the communications that are made between the implant telemetry 1160 and the RHC 1150 and the 1172 telemetry circuitry of the pump assembly 1170 with the connection1162 which is established in 1540 when assembly 1170 is found by the RHC 1150. In 1550, the RHC 1550 acts to retrieve and display data that is stored in memory 1174 of the implanted pump assembly 1170. In 1560, the RHC 1550 promotes , via Ul 1152 and screen 1154, for a pressure change input (for example, if the user wishes to change or adjust the pressure in gastric band 1190 to adjust band 1190). In 1570, the input has been received (such as via the user input via the 1164 keypad and / or Ul 1152) and one or more pressure change commands are sent via connection 1162 from the RHC 1150 to the assembly of implanted pump 1170. In 1580, the RHC 1550 awaits a confirmation of the implanted pump assembly 1170, which has completed the pressure change in the gastric band 1190 (for example, via the operation of the pump 1178 by the controller 1174 to add or withdrawing fluid via connections 1179, 1181 and fluid reservoir 1180 as discussed in detail with reference to Figures 1-10). The 1500 process can continue with the retrieval of additional data in 1550 or more typically, with the display of a confirmation and then the promotion of an additional change entry in 1560. An innovative feature of the 1100 system (and the systems in Figure 1) -10) is the ability for adoctor perform the remote adjustment of the band. Through the operation of the 1100 system, physicians or other operators are able to securely connect from their office computers to the RHC 1150. These connection and control communications are achieved through the operation of the physician's or other operator's computer, to "dial" and connect to the RAB 1100 system through a telephone MODEM or the connection on the 1110 support. The following sequence of events occurs in a mode to have remote access and control of the RAB system:(a) the patient connects the support 1110 to an active telephone socket 1102 using a standard telephone cord 1103, with the physician who is typically aware of the telephone number of the support / plug before attempting remote access; (b) the doctor uses the standard Windows dial-up network software to dial the RAB 1100 system; (c) the support 1110 contains the telephone interconnection and the circuit set 1112 of the MODEM, and after the detection of a telephone call signal over the telephone line 1103, the support 1110 automatically "enters into communication" and the MODEM 1112 is activated; (d) MODEM 1112 on support 1110 establishes a connection 1103 with the MODEM of the physician's computer (not shown); (e) the support 1110 then establishes a wireless 1118 data connection between the modem or the interconnection1114 and the RAB Manual Controller 1150, which contains the networking software (e.g., a TCP / IP stack run by the system controller 1156 and / or with the wireless interconnect 1158); (f) the RHC 1150 establishes a network connection with the physician's computer, with the connection that is typically coded and compatible with the secure connection of Microsoft Internet Explorer or similar; (g) the doctor launches the Microsoft Internet Explorer or a similar application on your computer or other remote controller and, using a predefined network address, has access to a network-based application over the RHC 1150, allowing full control of the function of RHC; (h) the physician performs all the permitted functions in the normal mode of operation (e.g. method 1500 of Figure 15) after entering the appropriate access codes (user name and / or keyword); e (i) the patient or operator of the RHC 1150 will be persuaded on the screen or monitor 1154 of the RHC on what action to take to facilitate the remote adjustment / control of the implanted pump assembly 1170, by the physician. In many cases, the wireless data connection will be either Bluetooth, ZIGBEE or another protocol / communication technique. The coupled mode of operation is mainly used to load the RHC 1150. However, remote access can be provided for the purpose ofpre-program an adjustment or recovery of patient data. In the low power operation mode, the RHC functions are suspended, except for the battery charge and charge monitoring. The operation of a self-regulating gastric band system has been described in detail with reference to Figures 1-15, but it may be useful to provide another summary of one embodiment of such a system. An implantable pump assembly is provided, which allows non-invasive pressure management of an implantable gastric band, and this function is typically invoked as a response to commands transmitted from the Manual RAB Controller(RHC) shown in Figures 11-15 or another controller. The implantable pump assembly and its components are internally energized (eg, locally energized by a battery or the like instead of remotely or externally to the patient's body). The implanted components (or the internal band adjustment system) include the following functional components: a housing; an external deposit; a manual gate; a fluid pump (for example, a Baterls pump of 1,406 kg / cm2 (20 psi) with active valve or similar); a set of control circuits (for example, to control the pump and any valves); the set of telemetry circuits and the antenna; and a battery and theset of power supply circuits. The RAB implantable pump can be implemented as a 1,406 kg / cm2 (20 PSI) piezoelectric pump (or other capacity), for example, a pump with an active valve incorporated in its design. The implantable pump is preferably auto-energized through a customary implantable battery, designed for long-term implantation. The pump has inlet and outlet valves. For a robust design, check valves at the pump inlet and pump outlet are used to eliminate or control the leak, such as the retention microvalves. For the release of pressure and pressure equalization, the system can use a piezoelectric or active valve or similar. The system pumps fluid directly from the tank into the belt, changing the belt pressure. The release of the band pressure is achieved through a separate sub-system. The increase in the pressure in the band is made directly by means of the pump. The decrease in pressure is achieved through the release of pressure followed by the re-pumping of the band at the proper pressure. The following describes the two band adjustment modes. In normal operation, a 1,406 kg / cm2 (20 psi) pump with check valve that withstands a minimum back pressure of 2,109 kg / cm2 (30 psi) maintains directional flow between an external reservoir and the gastric band. The pump, forexample, a piezoelectric pump of 1,406 kg / cm2 (20 psi) or similar, is for the increase of pressure in the band, and is monitored by a pressure sensor. Due to the nature of the piezo material, the flow is not reversible for the release of pressure in the band. The pressure is maintained in the band once the pump is turned off. No leakage or counterflow occurs due to check valves that are integrated in the pump or provided separately. To provide relief / pressure equalization, for the pressure relief in the band, an active valve / flow re-direction mechanism is used, for example, a piezo-active valve. The active valve is opened to equalize the pressure between the belt and the tank. Once the equalization is achieved, the active valve is turned off. The main pump is then activated to increase the pressure to the desired pressure in the gastric band. Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present invention has been made by way of example only, and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art. material, without departing from the spirit and scope of the invention, as claimed later in this. Forpracticing the invention, the gastric bands that are adjusted by the internal band adjustment systems of the invention, can be external to the stomach as shown in Figure 1, for example, or they can be provided or implanted internally to the stomach and / or to the esophagus, for example, the gastric bands regulated according to the invention can be intragastric bands. Such an intragastric band may take the same shape or form similar to the bands described with reference to Figures 1-10 or another form (such as the forms described in the following incorporated reference), and for example, may be coupled and / or implanted in a number of ways as shown in U.S. Patent Application Publication No. 2005/0192601, which is incorporated by reference herein.
It is noted that in relation to this date the best method known by the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.