Pressure sensing gastric banding system

• US 8,840,541 B2
• Filed: 02/25/2010
• Issued: 09/23/2014
• Est. Priority Date: 02/25/2010
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Snow, Sean, Birk, Janel
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/712,833
• Publication Number:
  US 20110208220A1
• Time in Patent Office: 1,671 Days
• Field of Search: 600/37, 600/488, 606/201, 606/202, 606/153, 606/157, 604/65
• US Class Current: 600/37
• CPC Class Codes: A61F 5/005 Gastric bands

Abstract

An implantable device monitors a pressure of fluid within an inflatable portion of a gastric band. The implantable device comprises a tube defining a lumen, and a pressure sensor positioned within at least one of the lumen or the tube. The pressure sensor is configured to sense the pressure of the fluid within the inflatable portion of the gastric band. The pressure sensor is also configured to transmit a pressure signal based on the pressure to a microcontroller, which transmits the pressure signal to a remote control device. The pressure sensor confers strain relief upon at least a portion of the tube, and the pressure sensor shields at least a portion of the tube from puncture by a needle.

Claims

1. An implantable system that monitors static and fluctuating pressure levels of a fluid moving to and from an inflatable portion of a gastric band, the implantable system comprising:

a first pressure sensor including,

a housing defining a cavity and having an open top portion,

a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting the fluid,

a pressure transfer fluid located within the cavity,

a sensing element, entirely positioned within the cavity of the housing and positioned adjacent to the flexible membrane, for measuring a pressure on the flexible membrane, the pressure being caused by the fluid contacting the outer surface of the flexible membrane, for converting the pressure to a pressure signal, and

a microcontroller positioned within the cavity of the housing and coupled to the sensing element, the microcontroller configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a location external to the implantable system; and

a second pressure sensor including,

a housing defining a cavity and having an open top portion,

a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting the fluid,

a pressure transfer fluid located within the cavity,

a sensing element, entirely positioned within the cavity of the housing and positioned adjacent to the flexible membrane, for measuring a pressure on the flexible membrane, the pressure being caused by the fluid contacting the outer surface of the flexible membrane, for converting the pressure to a pressure signal, and

a microcontroller positioned within the cavity of the housing and coupled to the sensing element, the microcontroller configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a location external to the implantable system,

wherein the implantable system is located within a wall of a tubing through which the fluid moves to and from the inflatable portion of the gastric band,

wherein the first and second pressure sensors monitor static and fluctuating pressure levels of a fluid moving to and from the inflatable portion of the gastric band by operating in a differential mode.

2. The implantable system of claim 1, wherein the pressure transfer fluid is degassed silicone oil.

3. The implantable system of claim 1, wherein, for each of the first and second pressure sensors, the respective flexible membrane moves toward the respective sensing element when the fluid applies pressure to the respective outer surface of the flexible membrane.

4. The implantable system of claim 1, further comprising a remote device, wherein the remote device is configured to receive the pressure signal transmitted by the microcontroller of the first pressure sensor and the pressure signal transmitted by the microcontroller of the second pressure sensor, and wherein the remote device wirelessly provides power for operation of the implantable system.

5. The implantable system of claim 4, wherein the remote device receives the pressure signal transmitted by the microcontroller of the first pressure sensor and the pressure signal transmitted by the microcontroller of the second pressure sensor and displays the pressure signal transmitted by the microcontroller of the first pressure sensor and the pressure signal transmitted by the microcontroller of the second pressure sensor on a display component of the remote device.

6. The implantable system of claim 1, wherein for each of the first and second pressure sensors the pressure on the respective flexible membrane changes an electrical property of the respective sensing element.

7. The implantable system of claim 6, wherein the electrical property is detected by periodic or continuous polling of the respective sensing element by the respective microcontroller.

8. The implantable system of claim 1, wherein the first and second pressure sensors are disposed in a lumen in fluid communication with the inflatable portion, and wherein the lumen comprises a plurality of extensions constructed to pass the fluid by the first and second pressure sensors.

9. The system of claim 8, wherein the lumen is disposed within tubing, and wherein the plurality of extensions allow the fluid to pass by the first and second pressure sensors when the tubing is kinked.

10. The implantable system of claim 1, wherein for each of the first and second pressure sensors, at least one of the respective sensing element and the respective microcontroller are at least partially immersed in the respective pressure transfer fluid.

11. The implantable system of claim 1, wherein for each of the first and second pressure sensors, the respective pressure signal is based in part on the pressure of the respective pressure transfer fluid caused by the fluid contacting the respective outer surface of the respective flexible membrane.

12. The implantable system according to claim 1, wherein at least one of the sensing elements and the microcontrollers are at least partially immersed in their respective pressure transfer fluid.

13. In a gastric banding system having tubing carrying fluid moving to and from an inflatable portion of a gastric band, an implantable pressure sensor that monitors static and fluctuating pressure levels of the fluid, the sensor comprising:

a housing defining a cavity and having an open top portion, the housing contained in at least a portion of the tubing;

a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting the fluid;

a pressure transfer fluid located within the cavity;

a sensing element, entirely positioned within the cavity of the housing and positioned adjacent to the flexible membrane, for measuring a pressure on the flexible membrane, the pressure being caused by the fluid contacting the outer surface of the flexible membrane, for converting the pressure to a pressure signal; and

a microcontroller positioned within the cavity of the housing and coupled to the sensing element, the microcontroller configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a location external to the implantable pressure sensor.

14. The sensor according to claim 13, wherein the housing is integrated into the tubing.

15. In a gastric banding system having tubing that defines a lumen carrying fluid moving to and from an inflatable portion of a gastric band, an implantable pressure sensor that monitors static and fluctuating pressure levels of the fluid, the sensor comprising:

a housing defining a cavity and having an open top portion, the housing contained in the lumen of the tubing;

a flexible membrane covering the open top portion of the housing and having an inner surface facing the cavity and an outer surface capable of contacting the fluid;

a pressure transfer fluid located within the cavity;

a sensing element, entirely positioned within the cavity of the housing and positioned adjacent to the flexible membrane, for measuring a pressure on the flexible membrane, the pressure being caused by the fluid contacting the outer surface of the flexible membrane, for converting the pressure to a pressure signal; and

a microcontroller positioned within the cavity of the housing and coupled to the sensing element, the microcontroller configured to process the pressure signal received from the sensing element and transmit the processed pressure signal to a location external to the implantable pressure sensor.