Hydraulic gastric band with collapsible reservoir

• US 8,308,630 B2
• Filed: 08/04/2010
• Issued: 11/13/2012
• Est. Priority Date: 01/04/2006
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Birk, Janel A., Franklin, Ethan
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US12/850,038
• Publication Number:
  US 20100324358A1
• Time in Patent Office: 832 Days
• Field of Search: 600/37, 600 29- 31, 606139-158
• 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 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0053 remotely adjustable

Abstract

A self-regulating gastric band apparatus for adjusting stoma size. The apparatus includes an adjustable gastric band that has an inner ring expanding with injected fluid. A band adjustment assembly is provided for implanting with the gastric band that includes a sensor for sensing fluid pressure in the inner ring. The band adjustment assembly further includes a pump assembly connected to the expandable inner ring 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 being set to maintain pressure variations below a predefined variation limit generally corresponding with satiated fill volumes for a particular patient and implanted band. An elongated fluid reservoir may extend along a substantial part of a fill tube. A balloon-like expandable fluid reservoir in fluid communication with the pump assembly may store a volume of the fluid for adjusting the volume of fluid in the lumen. A protective outer sheath may be provided around the exterior of an expandable fluid reservoir in both a first, deflated state, and a second, inflated state of the reservoir.

Claims

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

a gastric band having an inflatable member;

a fill tube having a fill tube lumen in fluid communication with the inflatable member;

a reservoir having a reservoir lumen separate from the inflatable member and the fill tube lumen and being positioned longitudinally along and adjacent a substantial portion of the fill tube lumen, and being in fluid communication with the fill tube lumen and configured to hold a fluid;

a pump coupled between the reservoir and the inflatable member and configured to transfer the fluid between the reservoir and the inflatable member through the fill tube lumen;

a sensor coupled to the inflatable member and configured to sense an instantaneous pressure of the fluid in the inflatable member; and

a controller coupled to the pump and receptive to the sensor and configured to receive stored pressure data and automatically control the transfer of the fluid between the reservoir and the inflatable member through the fill tube lumen based on a comparison between the stored pressure data and the instantaneous pressure of the fluid in the inflatable member.

2. The self-regulating gastric band system of claim 1, wherein the stored pressure data is a target pressure value for the controller to automatically control the transfer of the fluid between the reservoir and the inflatable member so that the instantaneous pressure of the fluid in the inflatable member is substantially the same as the target pressure value.

3. The self-regulating gastric band system of claim 1, wherein the stored pressure data is an operating pressure range for the controller to automatically control the transfer of the fluid between the reservoir and the inflatable member so that the instantaneous pressure of the fluid in the inflatable member is within the operating pressure range.

4. The self-regulating gastric band system of claim 1, wherein the stored pressure data is a pressure bounds for the controller to automatically control the transfer of the fluid between the reservoir and the inflatable member so that the instantaneous pressure of the fluid in the inflatable member is not outside the pressure bounds.

5. The self-regulating gastric band system of claim 1, wherein the sensor is located within the inflatable member.

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

a gastric band having an inflatable member disposed around an inner periphery thereof;

a fill tube having a fill tube lumen in fluid communication with the inflatable member;

a reservoir having a reservoir lumen separate from the inflatable member and the fill tube lumen and being positioned longitudinally along and adjacent a substantial portion of the fill tube lumen, and being in fluid communication with the fill tube lumen and configured to store a fluid;

a pump coupled between the reservoir and the inflatable member and configured to transfer the fluid between the reservoir and the inflatable member through the fill tube lumen;

a sensor capable of receiving stored pressure data and configured to sense an instantaneous pressure of the fluid in the inflatable member and output an adjustment signal based on a comparison between the instantaneous pressure of the fluid in the inflatable member and the stored pressure data; and

a controller coupled to the pump and receptive to the sensor and configured to automatically control the transfer of the fluid between the reservoir and the inflatable member through the fill tube lumen using the adjustment signal received from the sensor.

7. The self-regulating gastric band system of claim 6, wherein the sensor is located within a fluid transfer path between the reservoir and the inflatable member.

8. The self-regulating gastric band system of claim 6, further comprising an external control device configured to wirelessly communicate with the controller.

9. The self-regulating gastric band system of claim 6, wherein the controller is configured to initially establish the stored pressure data for a particular patient by monitoring a pressure variation between readings of the instantaneous pressure of the fluid in the inflatable member for a plurality of fill volumes of the inflatable member.

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

a gastric band having an inflatable member;

a fill tube having a fill tube lumen in fluid communication with the inflatable member;

a reservoir having a reservoir lumen separate from the inflatable member and the fill tube lumen and being positioned longitudinally along and adjacent a substantial portion of the fill tube lumen, and being in fluid communication with the fill tube lumen and configured to store a fluid;

a pump coupled between the reservoir and the inflatable member and configured to transfer the fluid between the reservoir and the inflatable member through the fill tube lumen;

a sensor configured to sense an instantaneous parameter of the gastric band; and

a controller coupled to the pump and receptive to the sensor and configured to receive stored parameter data and automatically control the transfer of the fluid between the reservoir and the inflatable member through the fill tube lumen based on a comparison between the stored parameter data and the instantaneous parameter of the gastric band.

11. The self-regulating gastric band system of claim 10, wherein the sensor is selected from a group consisting of (a) a pressure sensor, (b) a stress-strain sensor, (c) a linear motion sensor, (d) a distance sensor, (e) a force sensor, (0 a thermal sensor and (g) a thickness gauge sensor.

12. The self-regulating gastric band system of claim 10, wherein the instantaneous parameter is selected from a group consisting of (a) a pressure of the gastric band, (b) a stress or strain of the gastric band, (c) a length in the gastric band, (d) a distance between a point on the gastric band and a reference point to detect a change in size of the gastric band, (e) a force exerted against an area by the fluid, (f) a temperature from a low level heat source to approximate distance and (g) a thickness of the gastric band.

13. The self-regulating gastric band system of claim 10, further comprising a valve coupled between the inflatable member and the reservoir and configured to prevent fluid migration when the valve is closed.

14. The self-regulating gastric band system of claim 10, further comprising an external control device configured to wirelessly transmit the stored parameter data to the controller and configured to wirelessly receive the instantaneous parameter of the gastric band from the controller.

15. The self-regulating gastric band system of claim 10, wherein the sensor is configured to be inactive and sense the instantaneous parameter of the gastric band when activated by the controller.