Self-regulating gastric band with pressure data processing

ES 2 392 886 T3

DESCRIPTION

Self-regulating gastric band with pressure data processing

Background of the invention

Field of the invention

The present invention relates generally to devices for controlling obesity, and, more particularly, to a gastric band or gastric band system or assembly configured to self-monitor and adjust size, i.e. internal diameter, of the gastric band in order to provide a continuous adjustment of the stomach size in a patient.

Relevant background

Severe obesity is an increasingly common chronic condition that is difficult for clinicians to treat with diet and exercise alone. Physicians use gastrointestinal surgery to treat patients who are severely obese and cannot lose weight through traditional means or who suffer from serious obesity-related health problems. In general, gastrointestinal surgery promotes weight loss by restricting food intake, and more specifically, restrictive operations limit food intake by creating a narrow passage or “stoma” from the upper part of the stomach. to the larger bottom, which reduces the amount of food the stomach can hold and slows the passage of food through the stomach. Initially, the stoma was a fixed size, but more recently clinicians have 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 adjustable gastric banding (AGB). In an exemplary AGB procedure, a hollow band (i.e., a gastric band) made of a silicone elastomer is placed around the stomach near its upper end, creating a small pouch and narrow passage (i.e., a stoma) in the rest of the stomach. The band is then inflated with a saline solution using a thin needle and syringe to access a small sample that has been 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 solution contained in the band through the port. access to change the size of the passage or stoma.

The provision of fine gastric band adjustments after initial stoma sizing has been shown to be a significant improvement in the adjustable gastric cerclage procedure. However, there is a continuing difficulty in determining when to further adjust the gastric band and when to increase or decrease the size or diameter of the band to achieve an intended stoma dimension. Numerous gastric bands have been developed to allow a practitioner or other technician to adjust an implanted gastric band. In general, these band systems include a sensor to measure or determine the parameters in relation to association with the patient and in response, the practitioner or technician acts to adjust the volume of fluid in the band based on the patient's parameters. , 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 monitoring device. A doctor or other operator then responds by loosening the gastric band by drawing a quantity of fluid from the band through the external access port and fill tubing. In another gastric band system, the components for adjusting the size of the gastric band are implanted into the patient, and when a physical parameter related to the patient is determined, such as stomach pressure or the physical position of the patient, it is actuated an external control unit located outside the patient's body to activate the implanted components to adjust the size of the band, for example, adding or removing a preset volume of fluid from the belt.

Although they provide improved control over adjustable gastric bands, current gastric bands do not meet the needs of patients. In part, the shortcomings of current adjustable gastric bands are due to the need for the patient to be treated by a doctor or other technician to adjust the size of the band and the formed stoma by means of an external control unit. Other deficiencies are related to the unreliability or imprecision of patient-related detection parameters and their correlation with a predicted stoma size. In addition, some of the current gastric bands require the insertion of sensors into the patient, such as inside or on the stomach to determine the pressure of the stomach. Due to these and other limitations of current technologies, there remains a need for an improved gastric buckling system, and for methods of adjustment in association with it, in order to provide improved adjustments to the size of a stoma in a patient. who is being treated for obesity.

Document US 5,938,699 A relates to an adjustable gastric cerclage device according to the preamble of claim 1.

ES 2 392 886 T3

Summary of the invention

The present invention overcomes the above problems and other problems, by providing a self-regulating gastric band system for implantation in an obese patient in order to automatically adjust the size of a stoma on a periodic or continuous basis. The system is "self-regulating" in some embodiments, because it includes a sensor to detect a property or parameter of an implanted expandable gastric band and a band adjustment assembly or system that adjusts the size of the expandable gastric band in response to the property of the detected band. For example, a physician or other practitioner could set an operating margin for the property in system memory prior to implantation or afterward by means of an external monitoring device. The sensor operates periodically, on a continuous basis, or after being activated to detect the property of the band (such as fluid pressure within an expandable inner ring or band member). The sensor or a controller functions to determine if the band is within the intended range based on the sensed property of the band, and if not, the controller acts to adjust the size of the band to bring the band or its sensed property. back to operating range, such as by operating a pump assembly to move fluid between a fluid reservoir and the expandable inner ring. The self-regulating gastric band system also typically includes a housing to enclose the components of the implanted system with the gastric band and a local power source that is implanted to supply power to the various components of the System such as pumps, the sensor, and the controller. Thus, embodiments of the gastric banding system could be viewed as "set it and forget it" gastric cerclage treatments for obesity.

The present invention is defined in claim 1. Advantageous further embodiments are specified in the dependent claims.

More particularly, a gastric band adjustment assembly is provided to be placed on a patient while the gastric band is implanted. The assembly includes a sensor used to take pressure readings or detect fluid pressure in a lumen of an expandable part of the gastric band. A pump assembly is connected to the lumen, and a controller is provided that operates the pump assembly to adjust the volume of fluid contained in the lumen based on pressure readings and a target pressure defined by the gastric band ( for example, a predicted pressure for the band stored in the memory of the set). The assembly further includes a pressure adjustment module (eg, a software / hardware application run by the controller) that processes the pressure readings to provide a target pressure setting. This processing could include determining pressure variations / standard deviations in first and second values ​​or data intervals for fluid volume (i.e., first and second increments or fill levels) and then setting the target pressure. to correspond to one of the first and second values ​​or volumes for which the pressure variations have been determined to be smaller, and, in some cases, that are less than a predefined maximum pressure variation value or pressure variation limit for the gastric band. For example, the pressure swing limit could be less than about 3.4x10³ N / m² (0.5 PSI), less than 2.1x10³N / m² (0.3 PSI), or even more preferably less than about 6.9x10³ N / m² (0.1 PSI), and a fill volume could be set to correspond to the target pressure. The adjustment module could further operate to monitor pressure readings after the band has been filled to fill volume and to adjust the target pressure when pressure variations exceed the pressure variation limit in order to automatically adapt to variable treatment conditions. An external control device could be used to communicate wirelessly with the controller to modify the target pressure and / or fill volume and to retrieve pressure readings, which could be displayed such as a graph on a monitor of the external control device to provide feedback to the practitioner during band setting operations.

In a patient, a gastric band is implanted or positioned such that an expandable inner ring engages the patient's stomach and / or esophagus to form a stoma. One method could include providing a sensor operatively coupled with the gastric band to take fluid pressure readings on the expandable inner ring. A first volume of fluid is injected into the inner ring, the sensor is operated for a period of time to collect a first set of pressure readings, and then a pressure adjustment module is used to process the first set of pressure readings. pressure to determine a first set of pressure variations (eg, standard deviations, differences between maximum and minimum pressures, or similar parameters). The method continues with injecting an additional amount of fluid into the inner ring to provide a second volume of fluid in the gastric band. The sensor then operates to collect a second set of pressure readings, and the pressure adjustment module processes these pressure readings to determine a second set of pressure variations. The method continues with comparing the first and second sets of pressure variations with a pressure variation limit. Then a filling volume is configured for the gastric band that is equal to or close to the first second volume depending on which one had pressure variations that were less than the pressure variation limit. If both volumes have pressure variations less than the pressure variation limit, the method could include incrementally injecting additional amounts of fluid into the inner ring and then repeating the steps of operating the sensor, determining the pressure variation, comparing to the pressure variation limit, and set the fill volume until the pressure variation limit is exceeded. This method could be performed by an internal band adjustment system or by an external controller with the use of a sensor.

ES 2 392 886 T3 pressure provided at or near an access port that is connected to the inner ring by a fill pipe.

A method could be envisaged for adjusting the diameter or perimeter of the band and monitoring the pressure within an envelope that is filled with a fluid, a gas, a gel or a solid and that covers the inner surface of the band. By changing the diameter or perimeter of the band by mechanical or other means, pressure changes are made within the fluid-filled shell. As stated above, the pressure variation could be monitored over time when the band diameter is adjusted to monitor and analyze to set the band size below the configured maximum limit of variation (for example, to configure the size of the perimeter or diameter).

The above method of self-analyzing data could be applied to a manual access port used in conjunction with a hydraulically tightened gastric band. In such a case, a pressure sensor is placed within the access port or within the fluid path of the system during monitoring (the sensor could be attached to a syringe or syringe adapter) and used to remotely search for data from an external manual controller (or tabletop or similar). The band is adjusted (in addition to or instead of being adjusted by an automatic internal adjustment system) using a manual needle and syringe, and pressure data in some cases is collected during incremental fill volumes. The external or "remote" controller includes a processing module (or modules) that analyzes the data for pressure variations and indicates the optimal fill volume to the practitioner who adjusts based on analysis of the data (eg, by visually displaying sensed pressures , determined pressure variations, and / or a calculated fill volume for the particular band / fill pipe / port design based on analysis of sensed pressures and determined pressure variations). As noted above, the data could be displayed graphically and / or numerically at the controller to indicate the ideal pressure set value for the access port.

Brief description of the drawings

Figure 1 illustrates a self-adjusting (ie self-monitoring and self-adjusting) gastric band system in accordance with the present invention as it might appear installed in a patient;

Figure 2 illustrates a gastric band with an interconnected internal band adjustment system in fluid communication with band lumens such as could be used in a self-regulating gastric band system such as in the system of Figure 1;

Figure 3 is a cross-sectional view of the gastric band of Figure 2 taken on line 3-3 illustrating the expandable inner lumen used for fine adjustment of the inner diameter or size of the gastric band and an outer light that provides an internal or local reservoir for fluid for use in expanding (or deflating or contracting) the expandable interior lumen;

Figure 4 is a functional block diagram of a self-regulating gastric band system according to one embodiment of the invention;

Figure 5 is a schematic and / or functional block diagram of another embodiment of a self-regulating gastric band system of the invention more particularly illustrating one embodiment of a pump assembly useful for implementing the self-adjusting features of the invention;

Figure 6 is a cutaway perspective view of a physical implementation of the pump assembly of the invention, and in particular, of the pump assembly of the system of Figure 5;

Figure 7 is a schematic diagram similar to Figure 5 showing another embodiment of a self-regulating gastric band system of the invention using a different pump assembly 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 that uses 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 another embodiment of a self-regulating gastric band system of the invention that uses yet another pump assembly useful to implement the tightening properties. 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 sensor location with respect to the systems of Figures 5, 7, 8 and 9;

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Figure 11 is a functional block diagram of a self-adjusting or adjusting gastric band system that uses a manual controller that communicates with remote controllers or services (such as controllers or web-based services) via a link telephone;

Figure 12 is another functional block diagram showing the hand controller and cradle of the system of Figure 11 in further detail;

Figures 13 and 14 are perspective views of an exemplary implementation of a handheld controller and cradle in accordance with the present invention, such as to implement the systems of Figures 10 and 11;

Figure 15 is a flow chart of a normal mode of operation of a gastric band system, such as those described in Figures 10 and 11, for regulating the size of an implantable gastric band;

Figure 16 is a functional block diagram of a self-regulating gastric band system similar to that of Figure 4 according to another embodiment of the invention, showing the use of a software application or module to provide automated control (or optionally instigated by hand) of band pressure;

Figure 17 is a block diagram similar to Figure 16 showing a gastric band system according to another embodiment of the invention in which a pressure sensor is provided at or near an access port and a pressure analysis and an adjustment module are used by an external monitoring device to adjust the filling of a gastric band, and

Figure 18 illustrates a graph of gastric band pressure data, which could be historical or provided by means of a real-time visual display.

Detailed description of the preferred embodiments

In a nutshell, the invention is directed to a self-regulating gastric band or band system that allows an operator (for example, a physician or an assistant) to set operating parameters for a gastric band before or after its implantation in a patient. The self-regulating gastric band is then operable to directly monitor gastric band properties or in association with it, in order to determine if these monitored or detected properties are within configured operating limits or parameters, and then, if they are not within limits, automatically adjust the size of the gastric band (i.e. its internal diameter which establishes the size of a stoma in the stomach of the patient) so that the property or properties monitored or detected are within the present range or limits of operation.

The self-regulating gastric band systems of the invention can generally be used with numerous gastric band designs with many embodiments that are particularly useful for those that include an inflatable portion or inner lumen that expands or contracts by increasing or decreasing the volume of fluid contained therein. Generally, gastric band systems of the invention include one or more sensors to directly detect a band parameter, such as a fluid pressure in the inflatable part, and a controller that processes this detected band parameter or property to determine whether fluid is added or removed from the band to fine-tune its size (and the corresponding stoma size). A local fluid reservoir could be provided which is connected to a pump assembly, which is controlled by the controller to pump fluid into or out of the web. In one embodiment, the local fluid reservoir has been provided within the gastric band itself, for example, in an outer lumen or a ring or member of the reservoir. An internal fill tubing is connected between the pump assembly and the inflatable part or member of the gastric band to allow volume to be controlled locally (eg, in place of or in addition to a standard access port). Power for the pump, controller, and sensor assembly is typically delivered locally to the gastric band, i.e., intracorporeally or adjacent to the stoma or gastric band in the patient, rather than from an external source of power such as a induction power source. A memory is also in association with the controller to store band data and operating margins or band limits that are used to determine when to size the gastric band, and these operating margins or limits (i.e. , margin limits) could be configured prior to implantation or later configured or modified through 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 to 10.

Figure 1 illustrates a self-regulating gastric banding system or apparatus 100 as it might appear when installed in a patient being treated for morbid obesity. As shown in the figure, the system 100 is being used to form a stoma or a smaller opening in the upper part of the stomach near the esophagus to restrict food intake and flow. It is often helpful or even necessary to vary the size of the stomach to properly treat a patient. Thus, the self-regulating gastric band system 100 is intended to self-regulate its size based on sensed band parameters and operational parameters (such as a range of operational parameters with configured upper and lower limits). The gastric band system 100 includes a gastric band 110 that is inflatable by external or extracorporeal actions via a filling tube or tubing 112 that is connected to an access port 114 through which it can be

ES 2 392 886 T3 pumping fluid into the inflatable portion or member of the gastric band 110. Such filling is typically performed as part of an initial sizing of the stomach as part of the implantation process performed by the physician or other attendant.

Band 110 and other components of system 100 are implanted in the same or similar surgical procedure that is used with current expandable or inflatable gastric bands. For example, a surgeon would typically dissect the tissues around the stomach to create a tunnel for band 110. The band 110 is then introduced into the abdomen of the patient, for example, through an 18mm or other trocar or similar trocar or directly through the trocar hole in the skin. Band 110 is then tunneled into position and wrapped around the stomach. The other components of the system 100 including the internal band adjustment system or unit 130 are positioned close to the stomach (such as just under the skin at the top of the sternum or in the rectus muscle sheath near the access port) with a connection for fluids provided through the fill / drain line 120 to the gastric band 110 and in particular to the inflatable or expandable member or part of the band 110 (additional connections have been provided at embodiments where band 110 also includes a local fluid reservoir for use in sizing band 110). In other embodiments, connection 120 to fill line 112 is provided such that no other connection to band 110 is required.

The self-regulating gastric band system 100 includes an internal band adjustment assembly or unit 130 that functions to detect a band parameter, such as a fluid pressure in the inflatable or expandable part or lumen or in the fill line 112 or a property such as surface tension / strain on the web or similar property, to determine whether this sensed or monitored web property or parameter is within an acceptable predefined web operating range, and if not, sizing the gastric band 110. Typically, sizing is accomplished via fill / drain tubing 120 by adding or removing fluid, such as saline, to or from the band. 110, which is explained in detail with reference to Figures 4 to 10. The system 100 further includes an external monitoring or control device 150 that includes a display element 154 that is used to display data received through wireless communications 152 with the internal band adjusting system or unit 130, to display visually data such as new operating parameters to be sent to internal system 100, or to display historical data or other data in association with the gastric band 110. The external monitoring device 150 also includes a keyboard or other input area 156 to allow an operator to enter data or inputs (such as requesting data from the internal system 130, inputting a new setting value for gastric band 110 by adjusting its operating range, or a similar operation).

The gastric band 110 could take many forms to practice the invention and, for example, but without limitation, the gastric band 110 could be configured similar to the classic bands described in US Patent Nos. 5,226,429 and 5,601. .604 .. Alternatively, gastric band 110 could include one of the gastric bands available from Allergan, Inc. (for example one of the LAP-BANDTM family of expandable gastric bands such as 9.75 or 10.0, 11.0 cm, the VG, or AP-LAP BANDS) Other gastric bands from various manufacturers or Distributors that could be used for this application include, but are not limited to, the Obtech band, (Ethicon), the AMI band, the Heliogast band, the Minimizer band (Pier), and the Cousin Bioband.

Figures 2 and 3 illustrate one embodiment of a self-regulating gastric band assembly 200 that includes 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 detail in Figures 4 to 10, which generally includes a sensor or sensors to directly detect the properties of web 210, a memory controller, an internal power supply, and a pump assembly (not shown in Figures 2 and 3 but described with reference to Figures 4 through 10).

Gastric band 210 includes a filling tube or tubing 212 that is used to provide a fluid connection between an access port (not shown) and an expandable or inflatable portion or lumen 226 in band 210. A strap 214 with a recessed surface 200 and a raised portion 218 is provided with a buckle member 216 to allow the initial formation of a circular loop or band of a particular initial size or inside diameter when the band 210 is implanted around the stomach. of a patient (eg to initially size the band to 9 to 11 cm or other useful inner diameter) to provide an initial stomach size. To allow additional fine adjustment of the stoma, the gastric band includes an inflatable part or member that rests on the outer surfaces of the stomach.

As shown in the figures, gastric band 210 includes a molded casing or casing 220, an inner ring 222, and an inflatable part, member, or balloon 224 made of an elastic or other material that can be increased in size and then shrink in size. Inflatable member 224 includes an internal lumen 226 for received volumes of fluid, for example saline or the like. In accordance with a feature of the invention, gastric band 210 could be configured to provide a local fluid reservoir to store fluid to expand or deflate inflatable portion 224. In this context, inner ring 222, which is typically constructed of a more rigid than the inflatable member 224 and is attached at 321 (such as with adhesive) to the shell 220, includes a lumen or reservoir 323 for storing fluid that can then be pumped into the lumen 226 of

ES 2 392 886 T3 the inflatable part 224 by means of the internal adjustment system 230. The lumen or reservoir 323 is useful as a fluid store because a connecting tube or pipe to the reservoir 238 has been provided in the band adjustment system 230 internal (such as a pump) (not shown) in system 230.)

Fluid drawn from reservoir 323 formed by inner ring 222 is pumped through tubing 340 by inner band adjustment system 230 to lumen 226 of inflatable member 224 to increase the size of the gastric band (i.e., to increase the outside diameter of a cross section of the band 210 as shown in Figure 3) or to reduce the size of the inside diameter formed by the band around the stomach in order to reduce the size of the stoma formed in a patient. At other times internal adjustment system 230 is operated (based on sensed band parameters) to pump fluid from lumen 226 as shown by arrow 350 via fill and drain line 234 connecting lumen 226 of the inflatable portion 224 to inner band adjusting system 230 (to or a pump of system 230). Such removal of fluid from lumen 226 decreases the size of band 210 and inflatable member 224 while increasing the inside diameter formed by band 210 around the stomach and increasing the size of the patient's stoma. Fluid withdrawn from inflatable portion 224 is pumped into reservoir 323 as shown by arrow 340 for storage and later use in sizing or fitting gastric band 210.

Figure 4 illustrates in functional block form an exemplary self-regulating gastric band assembly or system 400. System 400 includes an external monitoring and / or control device 410 that wirelessly communicates 426 with an internal band adjusting system 430. In use, the inner band adjustment system 430 is implanted together with an expandable or adjustable gastric band 460 into an abdominal cavity of a patient to form a stoma in the patient's stomach for the purpose of treating obesity, i.e. the band Gastric is inflated or deflated by adding or removing fluid to change the size of the gastric band and the inner diameter of the band, IDBand, formed by the band in its circular configuration. The external monitoring and control device 410 could take the form of a handheld desktop laptop or communication device that includes a display element 412 for displaying information and an input / output component 414 to allow a user enter data or information such as a keyboard as input, a touch screen and / or voice data input properties and for wireless communications as shown at 426 with an input / output component of the internal band adjusting system 430. Device 410 further includes memory 416 for storing band data 418, such that it can be read from system 430 and provided by controller 432 and input / output 434 from internal system 430 and for storing band setting values ​​420, such as margins with operating limits (i.e. an upper limit and a lower limit such as for a pressure range) for the gastric band 460 that could be entered with the monitoring device 410 or be present in the internal system 430 and then read by the external device 410 for storage memory 416 and / or for modification or alteration by operation of external control device 410. Memory 416 can also be used by external control device 410 to store sensor data 422 (and, in some cases, patient data) obtained by sensor 450 of internal band adjusting system 430.

The internal band setting system 430 has been shown to include a controller 432, which could include a central processing unit (hereinafter CPU) and a code useful for controlling the operation of the system 430. The system further includes an input element / output 434 to communicate with external monitoring and control device 410. Memory 436 has been provided in system 430 to store band setting values ​​400, that is, an acceptable operating range for a particular property or parameter of gastric band 400 in which it is detected by sensor 450 such as a limit. upper and lower pressure (for example, 28x10³ N / m² and 34x10³ N / m² (4 and 5 PSI) when sensor 450 is a pressure sensor for the fluid in the inflatable portion of the gastric band 460. Band setting values ​​438 could be configured for the particular patient or as default setting values ​​prior to implanting the System 430 in a patient and / or band setting values ​​438 could be configured or modified after implantation by means of the external control / monitoring device 410 in order to alter the size of the gastric band 460 and the resulting inner diameter, IDBAND. Memory 436 could 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 gastric band 460 operation and band information such as serial number. , belt manufacturer, etc.

To monitor the performance of the gastric band 460, the system 430 includes the sensor 450 which preferably directly monitors physical properties or parameters of the gastric band 460. As shown, the sensor 450 could be provided in - or linked to - as shown in 452 - a pressure transducer or other device in a fluid link or connection 448 between gastric band 460 and pump assembly 442 of system 430. Alternatively, a pressure transducer or other pressure sensing device could be provided such as sensor 450 or in communication with sensor 450 to measure pressure in gastric band 460 such as by positioning on the inflatable portion of band 460, at an admission port to the band, into fill pipe 471 which is in communication with access port 474 and external fill device 470 (which in turn has been provided for initial filling of the inflatable or expandable portion of strap 460 or for adjusting optional rear 460 band). Sensor 450 could also be positioned in order to otherwise directly detect properties of web 460 such as those shown with tubing 456, for example, with a strain sensor indicating the surface tension of web 460 such as in a surface of the

ES 2 392 886 T3 inflatable or expandable part or by other useful sensing devices with the present size measurement of the gastric band 460.

Sensor 450 could include memory 466 to store band set values ​​438 such that when it detects a band parameter 460 that is outside of a preset range such as above a maximum set value or below the minimum set value sensor 450 can wake controller 432 to operate pump assembly 442. In other words, sensor 450 could be configured to be intelligent enough to determine when the gastric band is outside of a preset operating range and respond with alert or alarm signals to cause controller 432 to operate to control pump 442 including transmitting the detected band parameter to allow controller 432 to act appropriately to adjust band 460. Alternatively, sensor 450 could be operated periodically (or in some cases more frequently to near continuous operation) to take an additional reading of the band's property or parameter (as shown at 452 and 456) and to providing the sensed value to controller 432 which, in turn, acts to compare the sensed band value to band setting values ​​438 to determine if band 460 adjustments are required or desired.

In either case, a power source 444 such as a battery or similar equipment is used to power the controller 432 and other power consuming components of the system 430 such as that of the pump assembly 442 and the sensor 450. The system 430 further includes a pump assembly 442 and an internal reservoir 446. The pump assembly 442 could take a variety of shapes, such as those shown in Figures 5-10, to hydraulically adjust the size of the band 460 in response to information from the sensor 450, and the invention is not limited to one pump or one. fluid transfer device in particular. Internal or local reservoir 446 is in fluid communication with pump assembly 442 and provides fluid, such as a saline solution, to pump through fill or drain line 448 to band 460 to increase its size and reduce the inside diameter of the band and also provides a location to store fluid that is pumped or allowed to flow based on the pressure difference of the band 460 across line 448 and pump assembly 442. The reservoir 446 could be provided as a separate component in a housing (not shown) that is used to enclose or encapsulate the internal band adjustment system 430 or the reservoir 446 could be provided as a separate device, such as in the shape of a balloon-like structure, which is provided at a point near the housing of the system 230 of the band 460. In addition, in some embodiments, reservoir 446 could be provided as part of gastric band 460 itself such as in a lumen or outer member of the band shell, (as shown in Figures 2-3 and Figures 5 to 10).

With an understanding of the general characteristics of self-regulating gastric band systems, it might now be useful to describe in more detail 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 number of gastric bands, for example, those currently sold by Allergan, Inc., such as 9.75 cm, 10.0 cm, VGs, or AP LAP- BANDS. The pump set pump replaces the function of the manually adjustable access port. The materials used to construct the band will generally be the same as those normally used and the dimensions of the band, except the tube in the case of a local deposit that is provided in the casing or tube, which will remain the same. However, alternative materials could be employed to implement the invention such as materials specifically selected to improve performance, to increase acid resistance, or to obtain some other intended result. Similarly, there could be a minor change in the band tube to increase the outer diameter from 3.3 to 4.5 mm (0.130 to 0.180 inches) or more to increase the saline capacity in the outer or shell lumen. or in the tube to act as a reservoir for additional fluid or saline that can be used for future adjustments. The gastric band tube could have two lumens to separate the saline solution for the reservoir and the saline solution that is part of the band as shown in figure 2 and 3. In addition, a long balloon extended along the length of the gastric band could be placed. tube to act as a reservoir. The pump assembly will generally include one or more pumps, (or pump-like devices to move fluid in and out of the belt), electronic devices, communication components, computers or smart components, and a power source such as a battery. or batteries. The internal gastric band fitting assembly will be hermetically sealed within an outer housing constructed of a biocompatible material such as an acetyl copolymer, PEEK, titanium, or the like. In some embodiments, the power source is an implantable grade battery that is hermetically sealed in titanium prior to being placed in the pump assembly. The pump assembly could have a command transfer port that allows manual adjustments if necessary such as with external fill device 470 through access port 474 shown in Figure 4.

In some preferred embodiments, the self-regulating gastric band system functions automatically or as a fit and forget device. For example the system could operate continuously or periodically, such as hourly, daily, weekly, monthly, or some other selected monitoring period, to detect a band parameter or property and then adjust such as hydraulically inflating or deflating the gastric band with saline or other fluid. In some cases, the same or a similar specification for the saline fill volume and a burst of saline fill of the band will apply to the self-regulating gastric band system. The adjustments in these self-regulating embodiments are made by remotely activating a micropump or pumps coupled with the sensor and with control electronics. The sensor directly detects a

ES 2 392 886 T3 parameter or a property of the band for example, an internal pressure of the band, an internal or external parameter such as a tension or strain of the sheath. The sensor could also include a linear motion sensor that detects changes in length in the band or in the inflatable part of the band with the sensor or controller acting to convert this detected length deviation to measurements of stoma, or band diameter. . The sensor could also be a distance sensor that functions to detect the distance between two points to detect a change in position. The sensor could also be asked by an external monitoring or control unit via telemetry to collect data on the parameter being monitored for real-time feedback to the practitioner.

In some cases, the sensor is programmed to "wake up" at monitoring intervals or periods to monitor parameters and adjust the band to the ideal band parameters established through testing or established to better treat a patient over a period longer than treatment. . If the parameters are not within the ideal range, the sensor will send a command to readjust as necessary to ensure that the band reads within the ideal parameter control limits or, alternatively, the sensor will simply pass the information collected from the band to the controller for use in determining if the band is in a desired operating range. For example, the sector could “wake up” and determine if the band is monitoring an internal band pressure of X / m² (X psi ”) and determine based on a comparison with preset band parameters that the band needs to be adjusted so that the pressure of its internal fluid is in Y / N m². which could be a pressure at the center point within the operating range or any pressure within that range. The sensor, in this arrangement, will communicate to the controller to cause the controller to activate the implanted pump and send the volume of fluid to pump into the band or out of the band until the sensor readings are within ideal parameter limits, for example , by operating the pump until the sensor detects an internal fluid pressure in the band within or matches the center point of the present operating range (or other reset point stored in memory in association with the sensor or with the controller).

Micropumps draw power from the implanted battery or power source to allow for adjustment and, if included, the controller also activates one or more check valves to open (see Figures 5-10). band more or to finely increase its size, the pump pulls the fluid from the local reservoir into the band. To deflate the belt or to fine-tune its size, the pump pulls fluid from the belt back into the reservoir. Once the sensor reads within the specified parameter range, the valves will close to prevent fluid migration. The pump and sensor will then stop to conserve energy until the sensor “wakes up” again. Just like current bands, the fluid will be used to either inflate or deflate the shell to control stoma size but in this case size change 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 the parameter has changed, the value of the new detected setting or parameter or band property, and in some cases the deviation or the amount of the variation.

To externally monitor the reading of a parameter such as a new reading or an adjusted sensor parameter, a practitioner or system operator may use a handheld monitor or other externally sized monitor and a monitoring device external to the patient's body to request the sensor a reading or to ask controller for a more recently stored value, or both. Apart from the external monitor device and access ports, the system is self-contained to monitor and adjust itself. The pump assembly can store a variety of data in addition to band data and band acceptable operating range such as a serial number that can be remotely viewed by the external monitoring and control device to identify the implanted device including the implanted gastric band and the internal gastric band adjustment system.

The external device often takes the form of a manual control unit that may have a liquid crystal display and a control panel to operate the device. The manual feature may have a series of menus that allow the operator to program or read or determine the implant to contain in the second important information from memory such as the size of the band, the name of the patient, the doctor who has implanted it and the date of implantation. The handheld device can communicate with the sensor via telemetry via radio waves. The FDA and the world-renowned communications band (WMTS 402-405 Mhz) can be used in some embodiment and an authentication process can be used to ensure that the device cannot be accidentally accessed or controlled by a control mechanism other than manual. . The telemetry control signal can be sent from about 30 cm (one foot) or possibly farther away than the patient and will typically not require the patient to uncover himself to query the sensor or to change its parameters. During adjustments, the manual external monitoring device is preferably capable of reading and writing information to the implant such as current pressure or parametric data, the name of the adjusting physician, the date with the manual device which often works to save or retain the adjustment history in its own memory, (this history can be saved in the internal adjustment system, also or only). The handheld device could also be password controlled to prevent unauthorized personnel from investigating the device. The display of the handheld device, which could include visual and audio outputs, will typically display or output the detected web condition parameter or physical parameter whether this parameter or property is pressure, strain, tension, and / or or linear measure.

ES 2 392 886 T3

Regarding the duration of the sensor change, the search for the sensor will typically take only a few seconds, but the control of the micropumps can take longer, such as approximately 30 seconds per 6.9 x10³ N / m² (1 psi) of pressure change. Resolution of pressure readings and parameter ranges will be fine and preferably have a higher resolution than is currently possible by manual syringe settings. Regarding data storage, at least part of the information will be saved directly in the internal system implemented. To retrieve data, the handheld device could be used to query the device and display data on the screen, such as serial number, patient name, doctor name, band size, fill volume, and patient history. adjustment.

Regarding the power supply of the implant system, although the above specifically mentions an implanted battery, the implant could be powered by a variety of internal power sources that satisfy power requirements such as the following: (a) creation of kinetic energy by movement of the body stored in a condenser; (b) an implanted fuel cell; (c) an implanted power supply powered by body chemistry; (d) an implanted power supply powered by changes in temperature; and (e) implanted batteries that can be recharged by direct contact. The hand control device will typically be powered by rechargeable batteries while some embodiments could use other power sources. For example, a power cord could be provided to allow bus recharging between uses with, in most embodiments, a fully charged device performing a day's work as questions from 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 and safe operation and supports telematic communication with the implant. The system is configured to reduce the risk of infection and to improve patient comfort. The implantable battery or power supply provides a consistent and reliable power supply. The system can be operated to provide feedback on the status 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 the device 410 of FIG. 4, is configured to control the operation of the internal band setting system. In these embodiments, sensor 450 (or controller 432) is queried by external device 410 via telemetry 426 to collect data on the parameter being monitored by the sensor at 452 and / or 456. Based on the current readings, the practitioner or operator of device 410 who is collecting this information can then change the monitoring limits, (i.e., band set values ​​438 that could be programmed to sensor 450 when sensor 450 is configured to intelligently monitor the operating limits of the parameter band 460) such as to increase or decrease pressure or tension and deformation of the gastric band. Sensor 450 (or control 432 by storing new band set values ​​438) can then be reprogrammed to read data and determine if the new data is within the modified control limits. Sensor 450 sends a signal to control mechanism 432 to adjust band 460 such that (or until) sensor 450 reads data (i.e., a gastric band property or parameter) within control limits as values. band setting 420 or 438.

For example, a band could be monitoring or reading a band parameter (such as fluid pressure within band 460) between 13.8x10³ and 20.7x10³ N / m² (2 and 3 psi) when the practitioner prompts sensor 450 through operation of external device 410. The practitioner, physician, or other operator may then choose to increase the band monitoring interval, to an interval that is 34.4 x10³ N / m² (5 psi) at its center point. The clinician will reprogram the 450 sensor to monitor between 31x10³ at 37.9x10³ N / m² (4.5 to 5.5 psi) (as occurs by reconfiguring band trim values ​​420 and / or 438) and sending this to sensor 450 telemetrically 426. Sensor 450 reconfigures its monitoring limits (or controller 432 reconfigures its band set values ​​438 for use in comparison to sensor-derived band parameters) and communicates with controller 432 to activate implanted pump assembly 442 in such a way that a volume of fluid is pumped into the band or out of the band until sensor 450 reads (track 452, 456) within control limits.

During operation, the pump draws power from the implanted battery or power source 444 to allow adjustment and also activates any check valves to open (as indicated with reference to Figures 5-10). To inflate band 460, pump assembly 442 pulls fluid from reservoir 446 into band 460. To deflate band 460, pump assembly 442 pulls fluid from band 460 back to reservoir 446. Once sensor 450 reads within the specified parameter range, the appropriate check valves are closed to prevent fluid migration from or to band 460. To confirm the new pressure (or other band parameter) reading, the physician or operator uses handheld 410 to prompt sensor 450 for another reading. If confirmed, pump assembly 442 and sensor 450 are stopped until asked again to conserve power.

Figures 5 to 10 illustrate particular self-regulating gastric band systems that could be used to practice the invention. Each system described provides an alternate example of an effective pump set that could be used in a gastric band system (such as for gastric band pump sets).

ES 2 392 886 T3 inner band adjustment of Figures 1 to 4). Each of the disclosed systems employs a pressure sensor for use in sensing or determining fluid pressure in the inflexible or expandable part of the gastric band (hereinafter referred to as the "inner expandable ring). However, it should be remembered that the invention is not limited to just a pressure sensor and that many embodiments of the invention (including those described in Figures 5 to 10 with a replacement of the sensor) employ other sensors to directly detect one or more properties. gastric band or physical parameters of the same.

For example, but not limited to, the sensors used could include:

1. Pressure sensors, such as those available from CardioMems and Troníos Microsystems SA;

2. Implantable grade stress-strain sensors, for example those available from CardioMems and Troníos Microsystem, SA or being developed by these companies individually or in joint efforts with Inamed (the official assignee of the patent application);

3.Linear motion sensors, such as those available from Microstrain, Inc (for example, see http://www.microstain.com/imaqes/sensorman.jpq, which has been incorporated herein by reference);

Four. Distance sensors such as those distributed by Microstrain, Inc., s 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 under development by Verichip or by Verichip and Inamed (the assignee of this patent application), for measuring a thermal gradient from a low level heat source at an approximate distance; Y

7. Shell thickness gauge to detect reduction in wall thickness of a shell due to elongation during expansion.

Referring to FIG. 5, there is illustrated a schematic of a self-regulating gastric band system 500 that includes a gastric band 510 for implantation in a patient in a circular configuration around their stomach to form a stoma. Band 110 includes an outer ring reservoir 512 for storing fluid for use in sizing band 510, for example, A lumen could be provided in the outer ring or wrap of the band extending at least partially around the circumference of the band 510 or along the length of the band when not implanted or positioned 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. An expandable or inflatable outer ring 514 is provided in the band 510 that is formed of a material that allows it to expand when it receives a fluid and to deflate or contract when the fluid is removed or drained.

As discussed above, expandable gastric bands are well known in the art, and almost any of these known bands could be employed in system 500 with modifications to include outer ring reservoir 512 and fluid connection tubing 517 (or a tank fill or drain pipe) provided for tank 512. During use, the expandable inner ring 514 is filled and emptied of fluid through a fill pipe or tube 516 (which could more accurately be considered a band sizing pipe). Initial sizing of band 510 is done through manual or access port 518 that is typically implanted just below the patient's skin and is connected to fill tubing 516. Sizing includes a physician injecting a volume of fluid that is typically selected for gastric band 510 in an attempt to obtain a predicted inner diameter of band 510. Fine tuning and continuous self-regulation are performed on system 500 using a system. internal band adjuster comprised of a pump assembly 530, a sensor 522, a power source 528 (eg, one or more batteries), and control and communication components. Although not shown, the system 500 could interact with an external monitor and control device as noted in detail above. In this sense, an antenna or other wireless communications component 524 is provided in the internal assembly and linked to the control 526, and this antenna 524 allows the use of telemetry to communicate the parameters of the band and other information (again, as has been said in detail above) with the external monitoring and control device.

As illustrated, a housing 520 is provided so that the components of the inner band adjustment system can be isolated within the patient. Within housing 520, a pump assembly 530 is provided along with sensor 522, antenna 524, control 526, battery or power supply 528, and memory 529 (which could be incorporated into sensor 522 or the control 526). Sensor 522, control 526, battery 528, and memory 529 provide the functionalities described in detail in Figure 4 and in the preceding description. In this embodiment, sensor 522 is a pressure sensor for sensing fluid pressure in expandable inner ring 514. In this sense, fill line 516 is routed to housing 520 from access or manual port 518 through or via contact with sensor 522 to the entrance of expandable inner ring 514. In some embodiments, sensor 522 includes a pressure transducer that can directly sense back pressure.

ES 2 392 886 T3 applied by the fluid in the expandable inner ring 514 over the fluid in the fill line 516. In other embodiments, the sensor 522 or a portion of the sensor 522 is provided on the band 510 such as at or near the Inlet port to expandable inner ring 514 for fill pipe 516 or inner to expandable inner ring 514.

Sensor 522 could be inactive for periods of time and activated by control 526, by an internal timing mechanism, and / or by an external monitoring device. The 522 sensor when activated takes pressure readings and supplies them to the 526 control for storage in 529 memory and / or for comparison against a preset operating range (i.e., maximum and minimum pressure limits such as 20.7x10³ to 48.3x10³ N / m2 (3 to 7 psi) or more likely 27.6x10³ to 34.4x10³ N / m2 (4 to 5 psi) which could be considered band setting values) stored in memory 529. Alternatively, sensor 522 could have intelligence and memory and act to compare the pressure readings read (i.e., a property directly obtained band) with band setting values ​​programmed to sensor 522. When the pressure read in band 510 is outside the band setting values, sensor 522 could wake up controller 526 to operate to raise or lower the pressure in band 510 by actuation of pump assembly 530 to add or remove fluid from the expandable inner ring 514. Battery 528 provides a local power source for power consuming components within housing 520 such as control 526, sensor 522, and any electronic pumps and / or valves in pump assembly 530. In addition to band setting values, memory 529 could store pressure readings from sensor 122 and other data related to gastric band 510 (such as band identification information, implantation date, and similar information), as well as, in some cases, data related to the patient, (such as the patient's name, last date and time of treatment, and similar information.)

Pump assembly 530 generally functions to respond to control signals from control 526, either to pump fluid into expandable inner ring 514, or to withdraw fluid from expandable inner ring 514 to thereby size band 510, thereby which a parameter or property of the band monitored by sensor 522 is returned to be within an operating range or within band setting values. As shown, the pump assembly 530 of the system 500 includes a bleed valve 532 (e.g., a ceramic bleed valve or the like actuated by a spring stem) in fluid communication with the outer ring reservoir 512 through line 517. Bleed valve 532 is actuated by a 534 pump (for example, a 48.2x10 Bartel activator pump³ N / m² (7 psi) or other pump having the same capacity or higher or lower nominal pressure) that is primed with an internal reservoir 536. Bleed valve 532 is also shown connected to fill / drain line 516 of the expandable inner ring 514. The bleed valve 532 has been provided to allow the pump assembly 530 to equalize the pressure between the outer ring reservoir 512 and the expandable inner ring 514, which could be convenient in some embodiments (and when not, these components in relation to associated with bleed valve 532 could be omitted from pump assembly 530).

Additionally (or alternatively) bleed valve 532 could be used to drain or remove fluid from expandable inner ring 514. In these embodiments, sensor 522 could detect a pressure that is too high, that is, above an upper limit of a V band setting or operating range value, and control 26 could respond to a signal from sensor 522 to activate pump 534 to open bleed valve 532. A pressure difference between the outer ring reservoir 512 and the expandable inner ring results in fluid flow from the inner ring 514 through the fill line 516 and bleed valve 532 to the outer ring reservoir 512 (for example, this operative embodiment assumes that the fluid reservoir 514 is maintained at a lower pressure than the fluid in the expandable inner ring 512). Sensor 522 continues to monitor the pressure of expandable inner ring 512, and when it (or control 526) determines that the pressure is within the intended operating range (or more typically at or near the center point of that range), control 526 shuts down. Operate to deactivate pump 534 to close bleed valve 532.

Pump assembly 530 of system 500 also includes a pair of check valves 542, 546 (eg, Bartel's micro check valve or the like), between which is positioned a pump 540 (eg, activator pump. Bartel 20 PSI or similar). A check valve 542 is connected to the outer ring reservoir 512 through line 517, and a check valve 546 is connected to the expandable inner ring 514 through fill line 516. Pump 540 is connected between the valves check valve 542, .546 with flow during pumping from outer ring reservoir 512 to inner expandable ring 514. With this arrangement, pump 140 can be used to increase the size of band 510 when operated by control 526 to pump fluid from outer ring reservoir 112 through check valves 542, 546 to inner expandable ring 514 . Control 526 supplies a close signal when fluid pressure in inner expandable ring 514 is within the configured operating range (or at or near a center point or other preset point within that range), as determined by operation. 522 Sensor and 526 Control.

In some cases, the band 510 could be adjusted to be smaller by drawing fluid from the expandable inner ring 514 by means of the pump 540. In these embodiments, the sensor 122 could detect a pressure that is too low (i.e. that is, less than a lower limit of the operating range or band parameters), and supply this information to the control 526. The control 526 then sends signals to the control valves.

ES 2 392 886 T3 retention 542, 546 to open and allow fluid to flow back through pump 540 to outer ring reservoir 512 via tubing 517. This embodiment also assumes reservoir pressure outer ring 512 is less than fluid in expandable inner ring 514, and that pump 140 is configured to allow back flow when not actively pumping. When sensor 522 detects a pressure within the programmed operating range (or at a center point or other set point within this range) as determined by sensor 522 and / or control 526, control 526 operates to close check valves 542 , 546.

Figure 6 illustrates a physical layout for pump assembly 530. As shown, housing 520 is a one-piece unit or box that encloses sensor 522, control 526, battery 528, pumps 534, 540, and internal reservoir 536 (as well as other components of the pump assembly). The housing also provides fluid ports or connection points for fill line 516 and tank connection line 517. The materials used for housing 520 are preferably biocompatible, and housing 520 is preferably constructed to be leak resistant (ie, water or fluid tight) to withstand extended use of the assembly, as an implant. In other embodiments not shown, housing 520 could take different shapes such as a cylinder, square, or other useful shape and could be modular in such a way that the differing components are provided in two or more shells that can be attached or provided as separate modules.

Figure 7 illustrates a schematic of another embodiment of a self-regulating gastric band system 700. System 700 is configured similarly to system 500 with an adjustable gastric band 510 having an expandable inner ring 514 and an outer ring reservoir 516 with tubing of fill / drain 516 and 518, respectively. An access port 518 is connected to fill / drain tubing 516 to allow external filling of inner expandable ring 514 with saline or other fluid, such as during the implant process to initially size band 510. In a housing 720 , a sensor 322 is provided in fill / drain tubing 516 to sense gastric band fluid pressure 510 in inner expandable ring 514. An antenna 724, a control 726, a battery 728, and memory 729 have been provided with functionality similar to that of the analog components of the system 500.

The system 700 differs from the system 500 in the configuration of the pump assembly 730 provided as part of the internal band adjustment system in the housing 720. As shown, the pump assembly 730 includes a bleed valve 732 connected to the plumbing. fill / drain valve 516, 117 which functions similarly to valve 532 by operating pump 734 and reservoir 736 and control 726. However, pump set 730 differs from pump set 530 with the replacement of a single pump 540 by a plurality of pumps 740, 742, .744 (e.g. three 7 psi Bartel activator pumps or another pump useful for this purpose). function) that are arranged in series between check valves 746,748. Pumps 740, 742, .744 are operated by battery 728 and control 726 to pump fluid from outer ring reservoir 512 to inner expandable ring 514 when sensor 322 detects a pressure less than a preset lower pressure limit. Also, in some embodiments, check valves 746, .748 are opened by control 726 and powered by battery 728 to allow fluid in the inner expandable ring that is under pressure greater than a preset upper pressure limit as per is detected by the sensor 122 circulates outside the inner expandable ring 514 through the pumps 740,742, 744 to the outer ring reservoir 112 until sensor 722 and control 726 determine that it is within the preset operating range.

Figure 8 illustrates an embodiment of a self-regulating gastric band system 800 that is similar to systems 500 and 700 including an expandable gastric band 510 with a self-contained fluid reservoir 512 and within a housing 820 a pressure sensor 822, a module 824, a controller 826, a local power supply 828, and a memory 829. However, system 800 includes a pump assembly 830 in housing 820 that differs from pump assemblies 530, 730. As shown, an optional bleed valve 832 is provided between the outer ring reservoir and the inner expandable ring 514 which can function to maintain a predicted pressure difference between the fluid in these two parts of the band 510 (or system 800). For example it might be convenient on some 510 bands to keep a difference of less than approximately 13.8x10³ N / m² (2 psi) or less than about 1.7x10³ to 6.9x10³ N / m² or similar. In other, not shown embodiments of the system 800, the bleed valve 832 could be omitted.

To allow selective adjustment of the size of the inner expandable ring 514, the pump assembly 830 includes a pair of check valves 846, 848 connected to the fill / drain lines 516,517. The fluid movement or pumping forces are provided by a syringe or other chamber 842 that is in fluid communication with the two check valves 516, 517 and thus with the two reservoirs or parts 512, 514 of the band 510. Fluid is aspirated and forced out of chamber 842 by operation of a squirrel cage motor 838 that is sealed in an engine crankcase 834 having a bellows 836 to support movement of a shaft / plunger 840 connected to the motor 838 (for example a squirrel cage motor or the like) and chamber 842.

During operation of the system 800, the sensor 822 detects the pressure in the expandable inner ring 514 of the band 510. The sensed or monitored band property is either used by the sensor 822 to determine if the

ES 2 392 886 T3 web pressure is within the programmed or preset operating range or that determination is made by control 826. Once a determination has been made that the pressure is less than a preset lower limit or outside of a range, the control 826 operates the motor 838 to pump fluid from the outer ring reservoir 512 to the expandable inner ring 514 through check valves 846, 848 and fill / drain lines 516, 517 until the pressure in band 510 sensed by sensor 822 is within the preset operating range or typically some amount greater than the lower limit. When a determination has been made that the fluid pressure in the inner expandable ring 514 is greater than a preset upper limit or out of range, the control 826 could adjust the pressure (and the corresponding size of the ring 514) by opening the check valves. check valve 846 and 848 to allow fluid at a pressure greater than inner expandable ring 514 to flow to outer ring reservoir 512 through fill / drain lines 516, 517, until the pressure sensed by sensor 822 is back within range (or at a pressure a preset amount below the upper pressure limit.)

Figure 9 illustrates another self-regulating gastric band system 900 similar to systems 500, 700, and 800 in that it includes a gastric band 510 and a housing 920 that encloses a pressure sensor 922 in the filling line 516 of band 510. , a communication element or antenna 924, a control device 926, a battery 928, and a memory 929. The pump assembly 930 is similar to the assembly 830 in that it includes a bleed valve 932 in fluid communication with the inner expandable ring 514 and the outer ring reservoir 512 through lines 516, 517 to maintain a predicted pressure difference between the two lights or tanks 512, 514. The pump assembly 930 differs from the assembly 830 with the insertion between the check valves 942, 936 of a pumping mechanism that is constituted by a crankcase 934 that hermetically seals a squirrel cage motor 940 that is used to drive or moving a diaphragm 938 by means of a shaft extending through or into the bellows 936. The other operations of the system 900 are similar to those of the system 800.

Figure 10 illustrates a self-regulating gastric band assembly 1000 that is configured similarly to the system 500 of Figure 5. Differences between the systems (or unique aspects of the system 1000) include the positioning of the sensor 1022 external to the housing 1020 between the expandable ring. interior 514 and a check valve 1049 in fill line 516. Sensor 1022 is in communication (wired or wireless) with controller 1026, which act to communicate with an external monitoring and control device (not shown in Figure 10) through antenna or communication element 1024, to save data received from sensor 1022 and external monitoring and control device in memory 1029, and to power pump assembly 1030 as needed with battery 1028, which also powers controller 1026. Controller 1026 is also configured to operate (as discussed in detail above) pump assembly 1030 to automatically maintain band 510 within an intended operating range typically defined by a lower limit and an upper limit (eg, an upper limit). lower pressure and an upper pressure limit) pumping fluid in and out of the inner expandable ring 514 based on the band properties sensed by the sensor 1022 (For example, fluid pressure in line 516 and ring 514.)

System 1000 also differs from System 500 in the configuration of its pump assembly 1030. The pump assembly 1030 includes a bleed valve 1032 to bleed the higher pressure fluid from the inner expandable ring 514 (when sensed by the sensor and based on the control signals from the control 1026) to the outer ring reservoir 512. However, the 1030 set includes a different 1034 pump, for example a 34.4x10 Thinxxs pump³ N / m² (5 psi) or similar, from that used by System 530, which is primed by internal reservoir 1036 to actuate bleed valve 1032 in response to signals from control 1026. System 1000 further differs from System 500 in that a plurality of 1040, 1042, 1044, 1046 pumps (for example, 34.4x10 Thinxxs pumps³ N / m² (5 psi) or other useful pumps) are located between check valves 1048, 1049 and reservoir 512 and inner expandable ring 514 instead of a single pump 540. These series installed pumps 1040, 1042, 1044, 1046 are actuated to pump fluid from reservoir 512 to inner expandable ring 514 when sensor 1022 detects a pressure below or outside a minimum pressure that defines a lower limit of the intended operating range. or the pressure range programmed for band 510.

As can be seen in Figures 5-10, there are many different pump assembly configurations that can be used to implement the present invention. Additionally, other components could be varied to obtain the desired functionality of a self-regulating gastric band. For example, the systems shown in Figures 5 to 10 included a fluid reservoir provided with a lumen or integral part of the gastric band. In some embodiments, it may be desirable to have the fluid reservoir provided within the pump housing. In other cases, the fluid reservoir could be provided as a component external to the pump housing and external to the gastric band, such as by providing a separate elastic sac, balloon, or other similar structure that would be useful for storing fluid. to pump to the belt and out of the belt using the pump assembly.

In some embodiments, it is desirable to allow adjustment of an implanted band by a practitioner or other technician over a telephone link. In short, this is accomplished by providing a local controller for the patient and a remote local controller for the physician or technician, with the two controllers communicating via a wired or wireless telephone link. The local controller could be thought of as a remote adjustable band manual controller (hereinafter RAB) (or the controller could be fixed but 14

ES 2 392 886 T3 local to the patient) or a remote manual controller (hereinafter RHC). The main function of the RHC is: locate the implanted pump, control the implanted pump, provide an easy-to-use visual display of system status and programming, allow access to RHC functions via remote switched line connection, provide a web server application that allow web-based control of all functions when accessed via remote switched line connection, and provide a standard wireless link to a cradle, that provides load power to the controller and a telephone link (to access the web page or another controller). The local controller or the RHC could be used, for example, to communicate through the antennas of the systems shown in Figures 1 to 10, and the use of such an RHC is explained in more detail in the following description.

Figure 11 illustrates in functional block form a gastric band system 1100 using a controller RAB 1150 to control the settings of an implanted (or implantable) band 1190. Figure 12 illustrates the RAP controller 1150 and its cradle 1110, with more detail. As shown, the 1100 system includes an 1100 cradle to provide phone connections and power for a RAB or RHC 1150 handheld controller. In turn, the RHC 1150 is used to control by means of the data transferred over a wireless link 1162 an implanted pump 1160, which adjusts or regulates the size of the gastric band 1190 by controlling the transfer of fluid over the connection 1179. In this example. fluid is supplied via external reservoir 1180 (for example, external to a housing of pump assembly 1170 or via manual port 1184 (for example for initial fill or sizing of band 1190) via connections 1181, 1185. As previously described in pump assemblies, pump assembly 1170 includes telemetry circuitry 1172, a controller and memory 1174, and one or more hydraulic pumps 1178.

The RHC 1150 is shown to include a user interface 1152 and display 1154 along with a keyboard (or user input mechanism) 1164 to allow a user such as a gastric band patient or other 1100 system operator to view data from the pump set 1170 and data received remotely over the telephone link 1118 and to allow the user to make adjustments and enter data in some cases. The RHC 1150 further includes a system controller 1156, wireless circuitry and an antenna or cradle link 1158 to communicate with the cradle 1110, an implant telemetry 1160 to communicate with the telemetry circuitry 1172 of the implanted pump assembly 1170, and an 1168 battery / power supply to allow the RHC 1150 to be used outside of the 1110 cradle.

Cradle 1110 provides a power link 1128 by providing a power link 1115 to a power supply 1104 via power supply 1120 and RHC charger 1126. More significantly, the cradle 1110 includes a controller 1111 and a data / telephone link 1118 to facilitate remote control of the RHC 1150 and pump assembly 1170 via a telephone jack or other connection 110 that is linked 1103 with a connection interface. line 1112 to communicate with the RHC 1150 via an 1114 antenna / wireless communications circuit. The main functions of the RHC 1.110 cradle are: charge the RHC 1168 battery, store the RHC 1150 when not in use, provide a telephone / line interface including a modem (in some cases as shown in figure 12) for data access via the 1112 interface, implement a connection link 1118 standard wireless data between the modem and the RHC to allow remote access to RHC features and 1170 pump set, and to allow access to RHC functions through a remote switched connection.

Figures 13 and 14 illustrate a useful physical implementation of the RHC 1150 and cradle 1110. These figures show that the RHC 1150 can be easily removed and inserted or stowed for charging via the power connection (or stowage manifold) 1128 A telephone line 1103 is connected (or can be connected) to the cradle 1110 as is a power line 1105 (such as a 12V DC line). The display 1154 upon which a user interface 1152 would be provided is shown on the RHC 1150, as is a keypad 1164 and a power on / off switch or push button 1356. The RHC 1150 could be configured in a number of ways to include the implant telemetry access antenna and the standard wireless antenna 1156, 1160 these having been shown in figure 14 which are provided on the rear 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 easy manual operation to allow a user to position the RHC 1150 close to the patient and the 1190 gastric band to facilitate communications with the 1172 implant telemetry circuits in the 1170 pump assembly. , and ease of data input / output via display 1154.

It would now be useful to describe a few operational features of the 1100 and RHC 1150 system along with a description of their operations, with reference to FIG. 15, to regulate an implanted gastric band 1190. Useful features of the 1110 system and the RHC 1150 include: (a) the implantable pump 1170 that controls the RHC 1150 is self-powered and does not require power to transfer through the controller 1150; (b) implantable pump 1170 makes adjustments to band 1190 until a predicted band pressure (as opposed to a predicted volume) is achieved; (c) The RHC 1150 contains a standard 1158 wireless interface such as Bluetooth or ZIGBEE, which connects the RHC 1150 to the 1114 telephony interface in the RAB 1110 cradle, which in turn connects via interface 1112 and connection 1103 to a remote computer or controller (not shown) capable of switched access or other communication data and control information to the RHC 1150; (d) the RHC 1150 contains network software run by the controller 1105 and which allows connectivity from distant computers through the telephone interface provided by the cradle 1110 and wireless interface 1158; (e) the RHC 1150 contains a web server

ES 2 392 886 T3 run by the 1156 system controller which allows web-based access to all functions of the RHC 1150, including setup commands, after a switched network connection has been established over the telephone interface, which eliminates the need to install specific application software on the accessing computer (for example, in one embodiment, Secure Internet Explorer or an end connection is used)

The RHC 1150 operates in the following high-level modes: normal, remote access, docked, and no power. Figure 15 illustrates the operation of the RHC 1150 (or gastric band system 1100) in the normal mode for remote adjustment or regulation 1500 of a gastric band in a patient. In this mode the primary function of the RHC is to access and control the RAB 1170 Implantable Pump. Wireless access to the implantable pump 1170 could be, for example, through the band of the medical implant communications service (hereinafter MICS) operating in the frequency range 402 -405 MHz. The communication protocol between the RHC 1150 and the 1190 implantable pump could be kept in compliance with patient privacy regulations and healthcare industry regulations. The flow chart in Figure 15 shows a typical set of activities leading to an adjustment. Adjustments are typically in the form of pressure changes in the band as opposed to discrete volumetric changes.

In the normal regulation or process 1500 mode, the RHC 1550 is powered on the 1510, such as by pressing a button or flipping a 1356 switch on the RHC 1150. In the 1520, a password entry might be required to use the RHC 1150 with the to prevent unauthorized users from adjusting the 1190 band. In 1530, the RHC 1150 is operated by the system controller 1156 to search for and find the implanted pump 1160 such as communications being performed between the 1160 implant telemetry on the 1150 RHC and the 1172 telemetry circuits of the 1170 set of devices. bomb with link 1162 being set at 1540 when set 1170 is found by rHc 1150. At 1150, the RHC 1150 acts to retrieve and display data that is stored in the memory 1104 of the implanted pump assembly 1170.

In 1560, the RHC 1150 moves via U and 1152 and screen 1154 for a pressure changes input (that is, the user wishes to change or adjust the pressure in the gastric band 1190 to adjust the band 1190). At 1170, input is received (such as via user keyboard 1164 and / or UI 1152 input) and a pressure change command is sent through link 1162 from RHC 1150 to implanted pump assembly 1170. In 1580, the RHC 1150 waits for confirmation from the implanted pump assembly 1170 that it has completed the pressure change in the gastric band 1190 (for example, through operation of the pump 1178 by the controller 1174 to add or remove fluid through connections 1179, 1181 and fluid reservoir 1180 as described in detail with reference to Figures 1 to 10). The process 1500 may then proceed with the retrieval of additional data at 1150 or more typically with the display of the commit and then expediting the input of additional changes at 1560.

An innovative feature of the 1100 system (and the systems in Figures 1-10) is the ability for a clinician to make remote band adjustments. By operating the 1100 system, clinicians or other operators are able to securely connect from their office computers to the RHC 1150. This connection and control communications are accomplished by operating the physician's computer or the computer of other operators for switched connections and connecting to the RAB 1100 system through a telephone model or link in the cradle 1110.

The following sequence of events occurs in one embodiment to remotely access and control the RAB system: (a) the patient connects the cradle 1110 to an active telephone jack 1102 using a standard telephone cord 1103, with the physician typically ascertaining the telephone number plug / cradle before attempting remote access; (b) the clinician uses standard windows networking software to dial the RAB 1100 system; (c) cradle 1110 contains modem and telephone interface circuitry 1112, and upon detection of a telephone ring signal on telephone line 1103, cradle 1110 automatically "picks up" and modem 1112 is activated; (d) the modem 1112 of the cradle 1110 establishes a connection 1103 with the modem of the physician's computer (not shown); (e) cradle 1110 then establishes a wireless data link 1118 between modem or interface 1114 and RAB handheld controller 1150, which contains network software (e.g., a TCP / IP stack run by system controller 1156 and / or with dynamic interface 1158: (f) the RHC 1150 establishes a network connection with the physician's computer, with the connection typically being encrypted and compatible with a secure connection from Microsoft Internet Explorer or similar; (g) the physician launches Microsoft Internet Explorer or similar application on his or her computer or other remote controller and, using a preferred web address, gains access to an RHC 1150-based application that allows full control of the RHC function; (h) the physician performs all the functions allowed in the normal mode of operation (for example, method 1500 in figure 15) after entering the appropriate access codes (username and / or password) and (i) the The patient or the operator of the RHC 1150 will be moved on the RHC screen or display 1154 as to what action to take to facilitate remote control or adjustment of the 1170 implanted pump assembly by the physician. In many cases the wireless data link will be either Bluetooth, ZIGBEE, or another communication technique or protocol that complies with regulations.

ES 2 392 886 T3

The docked mode of operation is primarily used to charge the RHC 1150. However, remote access could be provided for the purpose of pre-programming a setting or retrieving patient data. In the no-power mode of operation, the RHC functions are suspended except for battery charging and charge monitoring.

The operation of the self-regulating gastric band system has been described in detail with reference to Figures 1 to 15, but it might be useful to provide yet another summary of one embodiment of such a system. An implantable pump assembly has been provided that enables non-invasive pressure management of an implantable gastric band, and this function is typically called as a response to commands transmitted from the RAB RHC hand controller shown in Figures 11-15 or otherwise. controller. The implanted pump assembly and its components are internally powered, (ie locally powered by a battery or similar equipment rather than remotely or externally powered to the patient's body).

The implanted components (or internal band fitting system) include the following functional components: a shell; an external deposit; a manual port; a fluid pump (for example, a 138x10 Bartels pump³ N / m² (20 psi) with active valve or similar); a control circuit (for example, to control the pump and any valves); telemetry and antenna circuits; and a battery and power supply circuits. The RAB implantable pump can be deployed as a 138 x10 piezoelectric pump³ N / m2 (20 psi) (or other capacity) eg a pump with an active valve built into its design. The implantable pump is preferably self-powered by a custom implantable battery designed for long-term implantation. The pump has intake and discharge valves. For a robust design, check valves are used at the pump intake and at the pump discharge to eliminate or control leaks, such as micro check valves. For pressure release and pressure equalization, the system could use a piezoelectric or active valve or the like. The system directly pumps fluid from the reservoir to the belt, changing the belt pressure. Banding pressure release is done through a separate subsystem. The increase in the pressure of the band is done directly by means of the pump. The pressure drop is achieved by releasing pressure followed by pumping back the web to the appropriate pressure.

The two band setting modes are described below. In normal operation, a 138x10 pump³ N / m² (20 psi) with a check valve that supports a minimum back pressure of 207x10³ N / m²maintains a directional flow between an external reservoir and the gastric band. The pump, for example a 138x10 piezoelectric pump³ N / m2 (20 psi) or similar, is to increase the pressure in the belt and is monitored by a pressure sensor. Due to the nature of the piezoelectric material, flow is not reversible for pressure release on the web. The pressure is maintained in the band after the pump has stopped. There is no leakage or back flow because the check valves are built into the pump or provided separately.

To provide pressure relief or equalization, for pressure relief in the web, an active valve / flow redirection mechanism is used, for example a piezoactive valve. Active valve opens to equalize pressure between belt and reservoir. Once equalization has been obtained, the active valve is closed. The main pump is then activated to increase the pressure to the expected pressure in the gastric band.

As described above, it is sometimes convenient to monitor fluid pressure within an implanted gastric band. Furthermore, in some embodiments, it is desirable that the pressure of the band or the fluid in the band is automatically monitored and controlled or adjusted by an internal band adjustment system. This automatic adjustment could be combined with a periodic reporting of pressure set values ​​and readings to an external control device and, in some cases, with pressure set value changes provided by the external control device. In other cases, it may be useful to monitor pressure in the band, such as by means of a sensor in an access port, and to control the filling of the gastric band based on analysis or monitoring of the pressure in the band during such operations. fill. These pressure-based embodiments of the invention are explained in more detail with reference to Figures 16 to 18, and the aspects described below could be used alone or in combination with any of the preceding embodiments of the invention. The following embodiments of the invention also provide more details on the use of one or more software applications. e.g. pressure analysis and adjustment of software or modules, to facilitate automatic pressure control for a gastric band or to facilitate more accurate and / or efficient filling and band adjustment via an access port and the operation of an external filling device.

For example, another embodiment of a self-regulating gastric band assembly or system is shown in Figure 16. System 1600 has been shown to be a modification of system 400 of FIG. 4, similar numbered components not being explained in detail here. Of course, these modifications could be made to any of the self-regulating devices or systems described herein (such as those shown in Figures 5 to 12). The system 1600 is particularly adapted to self-adjust a gastric band 460 based on a sensed pressure of the fluid in the band 460 (for example, in the expandable part of the band.) To do this, the sensor 450 of the internal band adjustment system Band 430 is provided in fluid communication with band fluid such as by connection or placement in band 460, in line 448 or pump assembly 422, in line 478, or in a port access 474. Sensor 450 is used to detect or take fluid pressure readings in band 460 and controller 432 acts to store the

ES 2 392 886 T3 pressure reading 1620 in memory 436 (eg as part of stored data from sensor 440). In memory 436, one or more pressure targets 1630 (eg, pressure values ​​or levels) could also be stored as part of the band set values ​​438, and the controller 432 operates to adjust the volume of the fluid in the band 400 via the reservoir 448 and pump assembly 442 to maintain this target pressure 1630 (or to maintain the pressure of the fluid or the band within a range that encompasses the target pressure 1630 to allow for some variation as noted above). Pressure readings 1620 are communicated to an external monitoring and control device 410 wirelessly 426 via input / output devices 434,414. The data is stored as historical pressure data 1650 in the memory 416 of the external device 410. The patient pressure setting value 1640 is stored in the memory 416 and is provided or written to the memory 416 of the internal band adjustment system. 430 for use in controlling pressure in band 460. The sensed information 1650 could be reported to a user of the external device 410 by generating a pressure graph or report 1666 on display 412 (for example, see the report or graphs 1800 of FIG. 18 for an example. ).

To allow continuous self-adjustment of pressure, the internal band adjustment system 430 includes a pressure adjustment and analysis module 1610. This could be a software application or combination of software and hardware that is run by the controller 432. to process the pressure reading 1620 to determine if the pressure target 1630 is being maintained during continuous operations. However, significantly, the 1610 module can also be used to initially set the pressure target or ideal 1630 pressure setting value for a particular patient based on the analysis of the 1620 pressure reading. Then, once configured, the module 1610 could be used to adjust the pressure of band 460 in a continuous manner and / or in response to commands or inquiries from external device 410. In some cases, controller 432 could also operate to reduce pressure in strap 460 when there is an obstruction or other problem or event for a patient for whom it is desirable to temporarily loosen strap 460.

The operation of the system 1600 and the use of the pressure adjustment and analysis module 1610 are now described in detail with reference to Figure 16 and also to Figure 18. The pressure graph 1810 of Figure 18 illustrates a pressure graph at a function of time for a gastric band, such as band 460, installed in a patient. Pressure data 1620 was collected from sensor 450 over a period of time and over a number of web fill or wear operations including nominal or initial fill, post adjustment, or increased fluid volume of the web, and an additional setting to increase fluid volume to a point of overfill. The 1810 chart is useful in showing how the 1620 pressure data can be analyzed by the 1610 Pressure Analysis and Adjustment Module to establish a 1630 pressure target and identify when additional adjustments might be desirable (for example, when the 1630 target of pressure should be adjusted up or down to accommodate varying operating parameters such as changes with respect to the patient and / or associated band or equipment).

Graph 1810 is representative of a real-time pressure curve generated from pressure readings 1620 of an actual patient in which a band 460 has been implanted. Initially, the band 460 could be filled with a nominal amount of fluid to get a first or a second pressure (for example, about 34x10³ to 48x10³ N / m² (5 to 7 PSI) as shown in 1820. This first part of curve 1810, that is, from 0 to 517 seconds, corresponds to when band 460 was at a filling volume that induced satiety in a patient or it was slightly overfilled beyond that point .. During experimentation, this fill point was initially determined by filling the band, such as with external fill device 470, and receiving feedback from the patient to identify nominal fill to obtain such feelings of satiety. The inventor observed that there was very little variation in pressure, PVAR, as measured from the maximum and minimum pressure values ​​read at a particular fill volume or by determining a standard deviation in the readings. This minor variation in pressure is shown in the two pressure stages of the time from 0 to 517 seconds.

In the second part 1830 of curve 1810, the band 460 was filled with additional fluid in order to increase the pressure, for example to an average or average pressure of about 55x10³ N / m² (8 PSI) in this example. At this point in the experiment or study, that is, from about 517 to about 900 seconds, the patient reported that they were or felt overfilled and that the patient was slightly uncomfortable. The pressure variations, PV AR, (or standard deviation) in the pressure readings were significantly increased over the variations seen in the quenched fill portion of the 1820 curve. Furthermore, as band 460 was filled even further to an increasingly overfilled level of fluid as curve 1840 shows, the intraband pressure response increases in its variation as can be seen from about 1033 to 1377 seconds. Through this knowledge of an operating band 460, the inventor determined that the pressure adjustment and analysis module 1610 can be configured to determine a pressure target either without any input from an external device 410 or with an initial target provided by device 410.

In one embodiment, pressure adjustment and analysis module 1610 functions to analyze sensed fluid pressure in band 460 (e.g., band pressure) and to establish a target pressure adjustment value 1630 for band 460 (or for patient wearing band 460). To provide this functionality, the internal band adjustment system 430 could operate to wake up or activate the sensor 450 to take a pressure reading from the 18

ES 2 392 886 T3 fluid pressure in band 460 (eg, multiple readings per second or more or fewer readings). External fill device 470 could be used to provide conventional nominal fill of band 460. For example, it might be known that a volume of fluid can be added via access port 474 (such as with a needle) so as not to overfill the band but also that it would probably not place the band 460 at an ideal or target operating pressure 1630 for any patient.

After (or during) this fill, the 1610 module could cause the 432 controller to collect 1620 pressure readings over a period of time (or collect a set number of readings) with the 450 sensor. These pressure readings could match the stage initial part of the 1820 first part of the 1810 pressure curve, which in this example is about 34x10³ N / m² (5 PSI). Module 1610 operates to analyze pressure variation (eg, between a maximum and a minimum) in this fill volume. This maximum (or mean) determined pressure variation PVAR or a standard deviation could be stored in memory 436 and compared to a preset maximum acceptable pressure variation. If this preset maximum is not exceeded (which is likely the nominal initial fill level), module 1610 causes controller 432 to operate pump assembly 442 to pump fluid from reservoir 448 to band 460 to increase pressure to a near value of a₃juste i₂ncremental that is greater than the nominal setting value by a particular amount (for example 3.4x10³ N / m² (0.5 PSI), 6.9x10³ N / m² (1 PSI), 14x10³ N / m²(2 PSI) or in some other useful increment), such as from 5 psi to around 7 psi as shown in the example in Figure 18. In some cases, the 1610 module could cause the 432 controller to add a volume preset to band 460 to increase or decrease the pressure of band 460 rather than adjusting it to a preset pressure increase.

At this new volume / fill level or pressure, sensor 450 is used to collect another set of 1620 pressure readings. Module 1610 processes these readings to determine a pressure variation (or standard deviation for the readings) and compares this variation or deviation with a preset maximum. Again, if the maximum is not exceeded, (ie, the pressure variation is relatively small), the module 1610 determines that the band 460 may not yet have reached its ideal pressure set value. This target or ideal setting value is, in this case defined, as one in which the pressure readings are maximized, but the pressure variations as measured by difference between maximum and minimum values ​​(or as a standard deviation) while that a fill volume remains stationary or constant. In other embodiments, a pressure value below said maximum pressure but above pressure in association with the nominal initial fill volume for band 460 is used in operations. The 1630 target pressure could be similar across a patient population, but will typically vary enough due to manufacturing tolerances and differences between patients to make it convenient for the 1710 module to be operable to identify a 1630 set point for a particular patient after band 460 has been implanted.

If the pressure still does not vary significantly and does not exceed a preset maximum pressure variation (as shown in the second stage of curve portion 1820), the module 1610 stores the determined pressure variations in memory 436, such as in sensor data, and causes controller 432 to again operate pump assembly 442 to increase pressure in band 480 by pumping more fluid from reservoir with 448 to band 460. The band adjustment could continue until a pressure increase is reached or to add a preset increase in the volume of the band fluid. For example, pressure sensor 450 continues to collect pressure readings 1620 which are stored in memory 436. When adjustment is complete (for example, such as after a 3.4x10³ N / m² (0.5), 6.9x10³N / m² (1), 10x10³ N / m² (1.5), 14x10³ N / m² or a similar magnification or from about 48x10³ N / m² (7PSI) to 55X10³n / M² As shown in Figure 18, controller 432 stops operation of pump assembly 442 and continues to collect readings 1620 from sensor 450 (such as for a preset period of time or until a preset number of readings have been obtained such as defines modulus 1610). Module 1610 then determines a pressure variation at this new band fill level and compares this determined variation to the preset acceptable variation for band 460. If the determined variation does not exceed the maximum, another incremental change in fill for the web is initiated by module 1610, such as the pressure level shown in curve portion 1840 of FIG. 18.

In contrast, module 1610 could determine that at this new fill level that the band pressure has a pressure variation, PVAR, that is too large because it corresponds to or exceeds the maximum preset value for band 460. When making such a determination , module 1610 could act to cause controller 432 to operate pump or valve assembly 442 to reduce the amount of fluid in band 430 by returning or pumping fluid back to reservoir 448. For example, module 1610 could instruct controller 432 to return to the previous fill level (or previous band pressure) or to a fill level or volume (or associated band pressure) between the previous fill level and the previous fill level. current such as a midpoint between the two levels. Additional readings could be taken at this level and if the maximum acceptable pressure variation is not exceeded, the pressure in relation to this fill level could be saved as the 1620 target or ideal pressure for the patient (or the Fill could be increased incrementally and the process repeated one or more times before setting the target pressure 1620 to a level where the maximum pressure swing set value is not exceeded). If the pressure swing is exceeded, the fill may be further reduced until the pressure readings show that the swing set value is not being exceeded. The 1610 module can then be used to monitor the 1620 pressure reading on a continuous or more periodic basis and to operate the

ES 2 392 886 T3 controller 432 as described above to maintain the pressure of band 460 between the target set value 1630 or in a range that includes the set value 1630 (such as at the midpoint of the range.)

In a typical embodiment, the pressure readings 1620 during this process of identifying the target pressure 1630 and otherwise are stored in memory 436. Similarly, the module 1610 could store the pressure variations (or standard deviations) determined at each level. band fill as well as, in some embodiments, the volume of fluid added at each stage. This data is then transferred via wireless communications 426 to external monitoring and control device 410 for storage in memory 416, where it can be easily accessed for viewing and review such as by a doctor or other use of the device 410. In some In these cases, the transferred pressure readings 1650 can be used by the control device 1610 in generating graphs 1810 as shown in Figure 18. Rather than pure historical data, the graph 1810 can display at the device at 1666 how the data is being collected by the internal band adjusting system 430 to provide real-time feedback information. The information in memory 416 can also be transferred to a personal computer or other computing device for storage and / or later analysis.

System 1600 allows for real-time pressure monitoring of band 460. For example, device 410 (a handheld or tabletop device) typically includes software (not shown) to allow an operator to view the actual pressure output from the sensor 450 on a pressure graph or display 1666 (eg, a graph similar to curve 1810 of FIG. 18). The pressure display 1666 could include a pressure curve (for example curve 1810 or the like) and / or additional information such as mean pressure, standard deviation or pressure variation minimum pressure and maximum pressure measured over time. The curves on display 1626 are useful in allowing the operator such as a physician to view pressure changes within band 460 while treating a patient or adjusting band 460. For example, after a routine band adjustment where a doctor added fluid with the gastric band such as through a 470 external filling device, it is typical for the doctor to ask the patient to swallow water and then ask how the patient is feeling. to ensure your belt has been adjusted to an optimal fill level or amount. With a 1666 curve / graphs on display 412, the clinician can not only listen to the patient for verbal feedback but also match it with measured pressures and pressure variations or changes after an adjustment to decide whether further adjustments might be helpful or advisable.

The curves or changes in pressure are generally generated by peristalsis in the esophagus that is transferred to the stomach and the added band 460. This can be thought of as a column of pressure that is pushed down into the stoma from the esophagus and through the stoma into the stomach / band interface. As described above, the 1610 software module acts to analyze pressure readings from the sensor in fluid communication with the web fluid in order to identify when these changes or variations are within an acceptable range (for example, below of a preset maximum variation or standard deviation).

The preset maximum deviation used by the 1610 module could be configured per band in a number of modes. For example, the maximum preset pressure variation or standard deviation could be set for all bands in a consistent manner or set for a particular implanted band. For example, the preset maximum could be determined by studying a group of patients to collect pressure data similar to those described with respect to curve 1810 of row 18 and based on this study, a maximum acceptable variation could be configured for a band design. particular (such as 0.3x10³ N / m² (0.05) to 3.4x10³ N / m² (0.5 PSI) and more typically less than about 1x10³ N / m² (0.15 PSI) or less than 0.7x10³ N / m² (0.1 PSI) .. This preset could then be programmed into each 430 system for use by the 1610 module in determining the 1630 pressure target for the particular patient (for example, providing a patient-specific target pressure for the band). .

The study of implant patients could be performed in a number of ways to determine the maximum preset pressure variation or deviation, but typically would involve some level of participation or feedback by the patient. In one embodiment, standard gastric band pressure data or readings were collected for a number of patients at various fill levels or volumes. Specifically, pressure readings were obtained after optimal fill levels were set (or before adjustment to increase fluid volumes in the band), after an adjustment (or injection of additional fluid), and when the patient was swallowing water. after finishing the setting. Patients were asked to participate in a study when they did not currently need an adjustment, that is, a physician had previously set the band to a target fill level of fluid volume and its associated pressure. Band pressure data was collected in these patients by inserting a needle into their access ports and connecting the needle's fluid path to a pressure transducer or sensor. The transducer used in this particular experiment was capable of obtaining multiple pressure readings per second and the equipment connected to the transducer could store those readings and also graph the results in substantially real time (and it is believed that similar equipment could be useful for systems 430 of the invention for sensors 450). It was observed that when a patient's band was at the optimal target set value provided by the physician, the pressure readings only varied minimally as shown in portion 1820 of curve 1810 of Figure 18. For example

ES 2 392 886 T3 this minimum variation could be less than about 0.7x10³ N / m2 (0.1 PSI). When the patient gradually swallowed water, increases in pressure were noted but the variations were still relatively small.

In contrast, when the volume of fluid in the band was increased to a point such that the patient indicated that he was appreciably uncomfortable, the mean or average pressure not only rose to a higher value, but the variations in pressure also increased. as can be seen from part 1830 of curve 1810. The relative intensity of these pressure curves was then correlated with the patient's comfort levels. When patients were notably uncomfortable, pressure curves were found to vary significantly, for example up to 14x10³ N / m² (2 PSI) or more. The greater the intensity of the waves or pressure variations, the longer they tended to last. Data was recorded and observed for each patient at each fill level, for example for two to five minutes at each level where the pressure did not drop (in addition to sensed pressure variations) unless fluid was removed from the the band. In these tests it was determined that when the band was returned to a lower or optimal fill level, (or a band pressure associated with that fill volume), the pressure variation again became negligible (i.e. relatively low such as below about 0.7x10³ at 1.4x10³ N / m² (0.1 to 0.2 PSI). This can be seen in the 1850 portion of the 1810 pressure curve shown in Figure 18. These experiments provided data to configure a maximum allowable pressure variation (or standard deviation) that can be used with a gastric band (but, in some cases, such experiments were preferably performed for each particular gastric band design because acceptable variations could vary with such designs). Based on this data, a pressure analysis and adjustment model, such as the 1610 module, can be designed that follows a similar process as observed by an individual patient to determine a pressure target for that patient with a particular gastric band (e.g. example, moving from a nominal fill volume to larger fill volumes and back again until a fill volume is identified for which the pressure swing remains below a preset maximum pressure swing set value. In other embodiments, the module (such as a 1610 module) is more complex and is also capable of establishing the maximum acceptable pressure variation through analysis of various fill levels and the variations identified at each level.

In some cases, it is desirable that the software provided in the internal system 430 of the system 1600 is provided with an external device in order to provide a new diagnostic tool for medical uses in the adjustment and use of gastric bands. Figure 17 illustrates one such setting tool for the 1700 system. This tool or system 1700 can be used to determine an optimal level of web adjustment or fill based on the pressure response in web 430 without requiring the implementation of an internal adjustment system and its associated sensors. The controller (such as a handheld 410) could be configured to allow a physician to gradually increase the pressure in band 460. To do this, system 1705 and a control device 410 (such as a handheld, tabletop, or electronic device) with a controller or processor 1710 that controls the operation of display 410, input and output 4 14, and memory 416 and run a pressure adjustment and analysis module 1720, which could be a software application similar to module 1610 in Figure 16. The memory is used to store band 418 data as indicated above, band 420 set values ​​that could include 1750 patient pressure set values ​​including the target or ideal pressure set value as determined by the 1720 module pressure analysis tuning tool, and sensor data 422 which could include real-time pressure data or pressure readings from a 1710 sensor and historical 1740 pressure data.

System 1700 is also configured to allow detection of pressure from an implanted gastric band 460, and in the illustrated embodiment, this is accomplished with a pressure sensor 1710 (eg, a pressure transducer or the like) that is mounted on or near the access port 474 in order to be in contact with the fluid in the fill line 478 (and thus with the fluid in the band 460). Sensor 1710 could also be provided with an external filling device 470 or a tubing between port 474 and device 470. In still other embodiments, sensor 1710 is provided on the gastric band 460 itself. Sensor 1710 is preferably selected to communicate wirelessly or with a wired connection (eg, a disconnectable connection) the pressures read or sensed at the inlet and outlet 414.

As with module 1610, module 1720 is preferably configured to allow an operator such as a physician to easily set a target or desirable pressure set value for band 460.

To do this, module 1720 could be configured to process sensor 1710 pressure readings at one or more fill volumes for gastric band 460, such as when pressure is gradually increasing incrementally with external fill device 470 (e.g. , a needle) .. The module 1720 could function to generate graphs 1760 that are displayed by the controller 1710 on the display 410 (such as the curve / graph 1810 of FIG. 18). This graph 1760 could be correlated to the patient in which band 460 has been implanted to identify associated fill levels and overfill levels (eg, portions 1820 and 1830, 1840, respectively, of curve 1810). Module 1720 could take this data to determine pressure variations or standard deviations at each fill level. Module 1720 could act to correlate variations in each fill level and supply. the recommended target fill pressure that results in pressure variations that ultimately remain below a particular level of variation (for example, such as below 3.4x10³N / m² (0.5 PSI), below 1.4x10³ N / m² (0.2 PSI), below 0.7x10³

ES 2 392 886 T3

N / m² (0.1PSI), or some other variation identified by an operator of the 1700 system 410 device or by the 1720 module itself) Data from memory 416 could be collected and downloaded to the physician's or operator's computer or computer system ( for example, a database in such a system) to track pressures over time for the patient. In this way, the system 1700 can be used to initially set a pressure for the band 460 and also to subsequently monitor the pressure of the band 460 by means of the sensor 1710 such as by prompting the sensor 1710.

Although the embodiment of the system 1600 of Figure 16 and other figures has generally been described as freestanding, there are situations where it is desirable for these systems to be controlled manually. For example, it might be desirable for a physician or other operator to initiate pressure monitoring operations of module 1610 in order to allow pressure readings 1620, 1650 to be viewed on a 1666 graph or for other reasons. In one implementation, the system 1600 is adapted to be awakened by an operator of the external device 410, such as a technician or physician, or by the patients themselves. This could be useful when there is an obstruction in the stoma, above the position of band 460. Obstructions result in patient discomfort. In such a case, device 410 could be operated to transmit a wake-up signal on connection 426 to internal band setting system 430. The 1610. module (or another software module) could process the wake-up signal and trigger a 460 band auto-tune. When an obstruction exists, the 1610 module will determine that the pressure readings 1620 from sensor 450 are too high or too low. above target set point 1630 (or outside of a desired pressure range relative to target set point 1630). Module 1610 responds to such high or out-of-range pressures by causing controller 432 to operate pump assembly 442, to decrease the volume of fluid in band 460 (for example, by pumping fluid to reservoir 448, or by opening valves to allow for flow.) Flow is carried out until the obstruction passes and the pressure is out of range on the low side. At this point, module 1610 automatically acts to fill web 460 with reservoir fluid 448 (for example, using power source 444 to operate pump 442.)

Similarly, in some cases it is desirable for the system 1600 to further include a quick release valve or other device to allow pressure to be automatically or manually drained from the web. For example, the 1600 system (or other systems described herein) could include a fluid release mechanism, which could include one or more valves or the like, that are remotely activated by an external controller to release a part. cavity fluid. Alternatively, the fluid release mechanism could be activated automatically such as by installing a safety valve (eg. a one-way check valve) in a tubing between the band or its sheath / cavity / lumen that is selected to open at pressures above a particular maximum pressure that could be associated with the particular gastric band or patient and / or the treatment regimen. In other cases, the fluid release mechanism could be part of the internal adjustment system or be provided by additional components and activated by commands of the internal controller, the processing module, and / or by commands of an external controller or monitoring device. In those embodiments, the measured pressure can be reduced in the event that the external controller, internal controller, or check valve or similar device has determined that the measured pressure of the fluid in the cavity is greater than an upper limit of the range. operating pressure or is greater than a second maximum pressure set above the upper limit (for example, 6.9x10³ to 14x10³ N / m2 (1 to 2 PSI) above upper limit or other maximum allowable pressure useful for a belt).

Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure is usually made by way of example, and that numerous changes in the combination and arrangement of the parts may be resorted to by those skilled in the art. technique without departing from the scope of the invention, as claimed hereinafter. To practice the invention, gastric bands that are adjusted by the internal band adjustment systems of the invention could be external to the stomach as shown in Figure 1, for example, or they could be provided or implanted internally to the stomach and / or esophagus, that is, the regulated gastric bands according to the invention could be intragastric bands. Said intragastric band can take the same or a similar shape of the bands described with reference to Figures 1 to 10 or another shape (such as the shapes described in the following incorporated reference) and, for example, could be added and / or implanted in a number of ways as shown in US Patent Application No. 2005/0192601.