Self-regulating gastric band with pressure data processing

• US 20070156013A1
• Filed: 06/22/2006
• Published: 07/05/2007
• Est. Priority Date: 01/04/2006
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Birk, Janel
• Granted Patent: US 8,043,206 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0066 Closing devices for gastric bands

Abstract

A self-regulating gastric band apparatus for adjusting stoma size is disclosed. The apparatus includes an adjustable gastric band that has an expandable portion containing a volume of fluid. A band adjustment assembly is provided for implanting with the gastric band that includes a sensor for sensing fluid pressure in the expandable portion. The band adjustment assembly further includes a pump assembly connected to the expandable portion and to a controller that can operate the pump assembly to adjust the volume of the fluid in the band based on the sensed fluid pressure. The band adjustment assembly includes memory storing an operating range relative to a target fluid pressure, and the pump assembly is operated to maintain the sensed band pressure within the operating range. The target pressure is set to maintain pressure variations below a predefined variation limit generally corresponding with satiated fill volumes for a particular patient and implanted band.

Claims

1. A gastric band adjustment assembly for placement in a patient with an implantable gastric band, the band adjustment assembly comprising:

a sensor for taking pressure readings of fluid in a lumen of an expandable portion of the gastric band;

a pump assembly connected to the lumen;

a controller for operating the pump assembly to adjust a volume of fluid in the lumen based on the pressure readings and a target pressure for the gastric band; and

a pressure adjusting module for processing the pressure readings and setting the target pressure based on the processing of the pressure readings.

2. The assembly of claim 1, wherein the processing of the pressure readings comprises determining pressure variations each comprising a difference between a maximum and a minimum pressure at first and second values for the volume of fluid and wherein the target pressure corresponds to one of the first and second values for which the pressure variations are determined to be lower or for which the pressure variations are within an acceptable range based on data analysis by the pressure adjusting module of the pressure readings for the patient over multiple sets of the pressure readings.

3. The assembly of claim 2, wherein the setting of the target pressure by the pressure adjusting module further comprises determining the pressure variations at the first value for the fluid volume are less than a maximum pressure variation value accessible to the pressure adjusting module, determining the pressure variations at the second value for the fluid volume are at least about the maximum pressure variation value, and setting the target pressure to correspond to the first value for the fluid volume.

4. The assembly of claim 1, wherein the pressure adjusting module processes the pressure readings to identify a fill volume of the fluid in the expandable portion at which pressure variations are less than a preset maximum pressure variation.

5. The assembly of claim 4, wherein the preset maximum pressure variation is less than about 0.3 pounds per square inch (PSI).

6. The assembly of claim 4, wherein the pressure adjusting module identifies the fill volume after the expandable portion has been filled to a nominal volume, the fill volume being greater than the nominal volume.

7. The assembly of claim 1, wherein the controller operates the pump assembly to increase the volume of the fluid in the lumen when a sensed fluid pressure determined from the pressure readings is below a lower pressure boundary value and to decrease the volume of the fluid in the lumen when the sensed fluid pressure is above an upper pressure boundary value and wherein the target pressure is between the lowers and upper pressure boundary values.

8. The assembly of claim 7, wherein the band adjustment assembly further comprises memory for storing the lower and upper pressure boundary values and the target pressure, wherein the pressure adjusting module operates to determine whether the sensed fluid pressure is between about the lower pressure boundary value and the upper pressure boundary, and wherein the pump assembly is operated by the controller until the pressure is determined to be at about the target pressure between the boundary values.

9. The assembly of claim 7, further comprising a communication module for receiving command signals from a monitoring device external to the patient, wherein the command signals comprise at least one of a new lower pressure boundary value, a new upper pressure boundary value, and a new target pressure, and wherein the new boundary values and the new target pressure are stored in the memory for use by the pressure adjusting module in processing subsequent pressure readings.

10. The assembly of claim 1, further comprising a fluid reservoir configured for storing a volume of the fluid for use in the adjusting of the volume of fluid in the lumen, the fluid reservoir being in fluid communication with the pump assembly.

11. The assembly of claim 1, further comprising a local controller communicating with the band adjustment assembly controller to provide command signals to operate the pump assembly and to retrieve information gathered by the band adjustment assembly controller and determined by the pressure adjusting module, wherein at least a portion of the pressure readings are provided in a graph on a display portion of the local controller.

12. The assembly of claim 1, further comprising a communication module linked to the controller and a manual port operatively coupled to the lumen for adjusting the volume of the fluid based on the pressure readings along with results of the processing by the pressure adjusting module both of which are at least partially transmitted to and displayed on an external monitoring device.

13. A self-regulating gastric band system, comprising:

a gastric band for engaging a patient'"'"'s stomach, the gastric band having an expandable portion with a cavity that has a size varying with a volume of fluid in the cavity;

means for measuring pressure of the fluid in the cavity;

means for adjusting the volume of the fluid in the cavity, the adjusting means comprising means for determining when the measured pressure is outside of an operating pressure range set relative to a target pressure and when determined outside the operating pressure range, means for increasing or decreasing the volume of the fluid in the cavity until the means for measuring pressure determines the pressure is within the operating range.

14. The system of claim 13, wherein the system has a fluid release mechanism remotely activated by an external controller to release a portion of the fluid from the cavity, whereby the measured pressure is reduced in the event that the external controller has determined that the measured pressure of the fluid in the cavity is greater than a upper limit of the operating pressure range.

15. The system of claim 13, the adjusting means comprising memory for storing a lower bound and an upper bound defining the operating range and a target pressure and comprising a pump selectively operable to pump additional amounts of the fluid into the cavity of the expandable portion until the means for measuring pressure determines the pressure in the cavity has a value of about the target pressure.

16. The system of claim 15, further comprising means for setting the target pressure to coincide with a fill volume of the fluid in the cavity at which pressure variations determined for the measured pressures at the fill volume are less than a predefined maximum acceptable pressure variation value.

17. The system of claim 16, wherein the target pressure setting means operates, prior to setting the target pressure, to determine pressure variations at an overfill volume of the fluid in the cavity that exceed the predefined maximum acceptable pressure variation value, the overfill volume exceeding the fill volume coinciding with the target pressure.

18. The system of claim 13, further comprising external control means for wirelessly communicating with the adjusting means to retrieve the measured pressures, to graph the retrieved measured pressures, to set the target pressure, and to initiate operation of the adjusting means, whereby the external control means can be used to facilitate passing of an obstruction by the gastric band.

19. A method for adjusting a volume of fluid in an expandable portion of a gastric band, comprising:

in a patient'"'"'s body, placing a gastric band comprising an expandable portion engaging the patient'"'"'s stomach and/or esophagus to form a stoma;

providing a sensor operably coupled with the gastric band for taking pressure readings of fluid in the expandable portion;

adding a first volume of fluid into the expandable portion;

operating the sensor for a period of time to obtain a first set of the pressure readings;

with a pressure adjustment module, processing the first set of the pressure readings to determine a first set of pressure variations;

adding an additional volume of fluid into the expandable portion;

operating the sensor for a period of time to obtain a second set of the pressure readings;

with the pressure adjustment module, processing the second set of the pressure readings to determine a second set of pressure variations;

comparing the first and second sets of the pressure variations to a pressure variation limit; and

setting the fill volume to correspond to a pressure variation less than the pressure variation limit.

20. The method of claim 19, wherein when the comparing indicates that the first and second sets of pressure variations are both less than the pressure variation limit, the method further includes incrementally adding additional volumes of fluid into the expandable portion and repeating the operating, processing, comparing and setting steps until at least a portion of a set of pressure variations corresponding with an incremental fill volume exceeds the pressure variation limit.

21. The method of claim 19, further comprising after setting the fill volume, adjusting an amount of the fluid in the expandable portion, operating the sensor to obtain additional pressure readings, processing the additional pressure readings to determine an additional set of pressure variations, comparing the additional set of pressure variations to the pressure variation limit, and adjusting the fill volume of the gastric band based on the additional set comparison.

22. The method of claim 19, wherein the sensor is operatively coupled to an access port connected by a fill line to the expandable portion and wherein the processing, comparing and setting steps are performed through operating a control device provided external to the patient.

23. A gastric band adjustment assembly for placement in a patient with an implantable gastric band, the band adjustment assembly comprising:

a sensor taking pressure readings for fluid, gas, gel, liquid or a solid in a lumen of an expandable portion of the gastric band;

means for adjusting a stoma created by the band in the patient proximate to the filled lumen;

a controller operating the adjusting means relative to the pressure readings and a target pressure for the gastric band; and

a pressure adjusting module processing the pressure readings and setting the target pressure based on the processing of the pressure readings.

24. The assembly of claim 23, wherein the pressure adjusting module processes the pressure readings to identify an ideal stoma size at which pressure variations are less than a preset maximum pressure variation.

25. The assembly of claim 24, wherein the preset maximum pressure variation is less than about 0.3 pounds per square inch (PSI).

26. The assembly of claim 23, wherein the controller operates the adjusting means to create a smaller stoma when a sensed pressure determined from the pressure readings is at or below a lower pressure boundary value and to create a larger stoma when the sensed pressure is at or above an upper pressure boundary value and wherein the target pressure is between the lower and upper pressure boundary values.

27. The assembly of claim 26, wherein the band adjustment assembly further comprises memory for storing the lower and upper pressure boundary values and the target pressure, wherein the pressure adjusting module operates to determine whether the sensed pressure is between about the lower pressure boundary value and the upper pressure boundary, and wherein the adjusting means is operated by the controller until the pressure is determined to be at about the target pressure between the boundary values.

28. The assembly of claim 26, further comprising a communication module for receiving command signals from a monitoring device external to the patient, wherein the command signals comprise at least one of a new lower pressure boundary value, a new upper pressure boundary value, and a new target pressure, and wherein the new boundary values and the new target pressure are stored in the memory for use by the pressure adjusting module in processing subsequent pressure readings.

29. A method of inducing weight loss in a patient in need thereof by controlling the flow of food through the patient'"'"'s stomach, the method comprising:

surgically placing a gastric band in or around the patient'"'"'s stomach and/or esophagus to form a stoma, the gastric band comprising an expandable portion for holding a variable volume of fluid and a sensor for monitoring the pressure of fluid in the expandable portion;

adding a first volume of fluid into the expandable portion;

operating the sensor for a period of time to obtain a first set of pressure readings;

processing the first set of the pressure readings to determine a first set of pressure variations;

adding an additional volume of fluid into the expandable portion;

operating the sensor for a period of time to obtain a second set of the pressure readings;

processing the second set of the pressure readings to determine a second set of pressure variations;

comparing the first and second sets of the pressure variations to a pressure variation limit; and

setting the fill volume in the expandable portion to correspond to a set of pressure variations less than the pressure variation limit.

30. The method of claim 29, wherein when the comparing indicates that the first and second sets of pressure variations are both less than the pressure variation limit, the method further includes incrementally adding additional volumes of fluid into the expandable portion and repeating the operating, processing, comparing and setting steps until at least a portion of a set of pressure variations corresponding with an incremental fill volume exceeds the pressure variation limit.

31. The method of claim 29, further comprising after setting the fill volume, adjusting an amount of the fluid in the expandable portion, operating the sensor to obtain additional pressure readings, processing the additional pressure readings to determine an additional set of pressure variations, comparing the additional set of pressure variations to the pressure variation limit, and adjusting the fill volume of the gastric band based on the additional set comparison.

32. The method of claim 29, wherein the sensor is operatively coupled to an access port connected by a fill line to the expandable portion and wherein the processing, comparing and setting steps are performed through operating a control device provided external to the patient.