Self-regulating gastric band with pressure data processing

• US 8,905,915 B2
• Filed: 07/18/2011
• Issued: 12/09/2014
• Est. Priority Date: 01/04/2006
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Birk, Janel A.
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US13/184,914
• Publication Number:
  US 20110275887A1
• Time in Patent Office: 1,240 Days
• Field of Search: 600/37, 600/300, 600/407, 600 29- 32, 606/157, 607/41
• 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 operates 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 remotely controllable, self-regulating gastric band system for treating an overweight patient, the gastric band system comprising:

a gastric band for implantation around an upper portion of a stomach of the patient, the gastric band having an inflatable portion disposed around an inner circumference thereof for containing a volume of a fluid, the inflatable portion connected to a first check valve that is movable between open and closed states to either permit or restrict flow of the fluid into or out of the inflatable portion;

a reservoir for storing a volume of the fluid, the reservoir connected to a second check valve that is movable between open and closed states to either permit or restrict flow of the fluid into or out of the reservoir;

a bleed valve in fluid communication with at least the reservoir;

a sensor for sensing an instantaneous parameter of the gastric band or the fluid;

a controller responsive to the sensor and configured to automatically control the volume of the fluid contained in the inflatable portion of the gastric band, the controller including at least one pump connected between the first and second check valves;

an external control device configured to be positioned outside the patient and configured to wirelessly communicate with the controller, the external control device configured to be remotely controlled via a web server application, and

a power source configured to be implanted in the patient for powering the system.

2. The gastric band system of claim 1 wherein the controller is configured to be awakened by the external control device.

3. The gastric band system of claim 1 wherein the reservoir is integrated with the gastric band.

4. The gastric band system of claim 1 wherein the controller includes a series of pumps connected between the first and second check valves.

5. The gastric band system of claim 1 wherein the controller provides a shut off signal when the sensor senses that a pressure of the fluid in the inflatable portion is within a set operating range.

6. The gastric band system of claim 1 wherein the controller operates the opening and closing of the first and second check valves.

7. The gastric band system of claim 1 wherein the bleed valve is operable to withdraw fluid from the inflatable portion.

8. The gastric band system of claim 1 wherein the bleed valve is in fluid communication with both the reservoir and the inflatable portion, and the bleed valve equalizes pressure between the reservoir and the inflatable portion.

9. The gastric band system of claim 1 wherein the first check valve, the second check valve, the bleed valve, the sensor, and the controller are provided in a common housing.

10. The gastric band system of claim 9 wherein the power source is provided within the common housing.