PRESSURE SENSING GASTRIC BANDING SYSTEM

• US 20110208220A1
• Filed: 02/25/2010
• Published: 08/25/2011
• Est. Priority Date: 02/25/2010
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: SNOW, Sean, Birk, Janel
• Granted Patent: US 8,840,541 B2
• Time in Patent Office: Days
• US Class Current: 606/157
• 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 device that monitors static and fluctuating pressure levels of a fluid moving to and from an inflatable portion of a gastric band, the implantable device comprising:

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, 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 device.

2. The implantable device of claim 1, wherein the sensing element is selected from a group consisting of a pressure sensor, two pressure sensors configured to operate in a differential mode, a flow rate sensor, and combinations thereof.

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

4. The implantable device of claim 1, wherein the sensing element is immersed in the pressure transfer fluid.

5. The implantable device of claim 1, wherein the flexible membrane moves toward the sensing element when the fluid applies pressure to the outer surface of the flexible membrane.

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

7. The implantable device of claim 1, wherein the remote device receives the pressure signal from the microcontroller and displays the pressure signal on a display component of the remote device.

8. The implantable device of claim 1, wherein the pressure on the flexible membrane changes an electrical property of the sensing element.

9. The implantable device of claim 8, wherein the electrical property is detected by periodic or continuous polling of the sensing element by the microcontroller.

10. The implantable device of claim 1, wherein the pressure transfer fluid contains no fillers having a negative coefficient of thermal expansion.

11. The implantable device of claim 1, wherein the implantable device is configured to withstand steam sterilization without damage to the sensing element.

12. The implantable device of claim 1, wherein the implantable device is configured to withstand a temperature in excess of 120 degrees Celsius without damage to the sensing element.

13. An implantable device that monitors a pressure of fluid within an inflatable portion of a gastric band, the implantable device comprising:

a tube defining a lumen and having a first end and a second end, the second end connected to the inflatable portion of the gastric band for allowing the fluid to flow through the lumen; and

a pressure sensor positioned within at least one of the lumen or the tube,

wherein the pressure sensor is configured to sense the pressure of the fluid within the inflatable portion of the gastric band,

wherein the pressure sensor is configured to transmit a pressure signal based on the pressure to a microcontroller,

wherein the pressure sensor comprises a rigid housing conferring strain relief upon at least a portion of the tube, and

wherein the pressure sensor shields at least a portion of the tube from puncture by a needle.

14. The implantable device of claim 13, wherein the pressure sensor comprises:

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, 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 device.

15. The implantable device of claim 13, further comprising an access port, coupled to the first end of the tube, for adding or removing the fluid from the inflatable portion of the gastric band.

16. The implantable device of claim 13, further comprising a pump, coupled to the first end of the tube, for adding fluid or removing fluid from the inflatable portion of the gastric band.

17. The implantable device of claim 13, further comprising a reservoir, coupled to the pump, for holding fluid added to or removed from the inflatable portion of the gastric band.

18. The implantable device of claim 13, wherein the pressure sensor draws less than 2 milliwatts of power during operation.

19. The implantable device of claim 13, wherein the remote control device provides power to the pressure sensor.

20. The implantable device of claim 13, wherein the remote control device requests pressure sensor readings from the pressure sensor and displays the pressure sensor readings.

21. The implantable device of claim 19, wherein the remote control device includes a memory for storing the pressure sensor readings.

22. The implantable device of claim 19, wherein the pressure sensor readings can be used to detect an event selected from a group comprising:

a movement of the gastric band, capsular contraction around the gastric band, a patient action, a leak of the fluid, an erosion within a stomach, a herniation of a stomach, a smooth muscle fasciculation, a reflexive muscle action, a muscle spasm, a muscle cramp, and combinations thereof.

23. The implantable device of claim 13, wherein the pressure sensor is disposed in the lumen, and wherein the lumen comprises a plurality of extensions configured to allow the fluid to pass by the pressure sensor in the event of kinking of the tube.

24. The implantable device of claim 13, wherein the tube has a cross section of at least one of a circle, an oval, an egg shape, a bullet shape, a rectangle, and a rounded conical frustum.

25. The implantable device of claim 13, wherein the pressure sensor shields at least a portion of the tube from puncture by a needle by virtue of the pressure sensor comprising a puncture-resistant material.

26. The implantable device of claim 25, wherein the puncture resistant material is a titanium housing of the pressure sensor.

27. The implantable device of claim 13, wherein the pressure sensor shields at least a portion of the tube from puncture by a needle by virtue of the pressure sensor being disposed between the lumen and the skin of a patient.

28. The implantable device of claim 13, wherein the tube comprises at least two portions.

29. The implantable device of claim 28, wherein the at least two tube portions are coupled with at least one hard connector, and wherein the at least one hard connector confers strain relief upon the tube.

30. The implantable device of claim 13, wherein the pressure sensor is disposed within a first portion of the tube wall that is thicker than a second portion of the tube wall absent a pressure sensor.

31. The implantable device of claim 30, wherein the thicker portion of the tube wall confers strain relief upon the tube.

32. The implantable device of claim 13, wherein the implantable device is retrofittable to an access port already surgically implanted in a patient.

33. The implantable device of claim 13, wherein the pressure sensor is operative free from interference from other mechanical and electrical components contained in one or more of an access port, a pump, or a valve coupled to the gastric band.

34. A system for facilitating obesity control, the system comprising:

an implantable gastric banding device including an inflatable member for containing fluid and restricting a patient'"'"'s cardia;

an implantable access port coupled to the implantable gastric banding device via a tubing, the implantable access port controlling pressure within the inflatable member;

an external remote control device capable of communicating with and powering a pressure sensor; and

the pressure sensor disposed at least partially within the tubing, the pressure sensor comprising;

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 a fluid within the tubing;

a pressure transfer fluid located within the cavity

a sensing element, 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 device.

35. The system of claim 34, wherein the pressure sensor is disposed in a lumen within the tubing, and wherein the lumen is configured with a plurality of extensions configured to allow the fluid to pass by the pressure sensor in the event of kinking of the tube.

36. The system of claim 34, wherein the tube has a cross section of at least one of a circle, an oval, an egg shape, a bullet shape, a rectangle, and a rounded conical frustum.

37. The system of claim 34, wherein the pressure sensor is disposed between the lumen and the skin of a patient, and wherein the pressure sensor shields at least a portion of the tubing from puncture by a needle by virtue of the pressure sensor comprising a puncture-resistant material.

38. The system of claim 34, wherein the pressure transfer fluid contains no fillers having a negative coefficient of thermal expansion.

39. The system of claim 34, wherein the pressure sensor is configured to withstand steam sterilization without damage to the sensing element.

40. The system of claim 34, wherein the pressure sensor is configured to withstand a temperature in excess of 120 degrees Celsius without damage to the sensing element.

41. A system for facilitating obesity control, the system comprising:

an implantable gastric banding device including an inflatable member for containing fluid and restricting a patient'"'"'s cardia;

an implantable fluid reservoir;

an implantable pump unit for controlling pressure within the inflatable member, wherein the implantable pump unit is in communication with the fluid reservoir and the gastric banding device via a tubing;

an implantable access port coupled to the implantable pump unit;

an external remote control device capable of communicating with and powering the implantable pump unit and a pressure sensor; and

the pressure sensor positioned within the implantable pump unit, the pressure sensor comprising;

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 a fluid within the tubing;

a pressure transfer fluid located within the cavity;

a sensing element, 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 device.

42. The system of claim 41, wherein the tubing comprises at least two tubing portions, wherein the at least two tubing portions are coupled with at least one hard connector, and wherein the at least one hard connector confers strain relief upon the tubing.

43. The system of claim 41, wherein the pressure sensor is disposed between a lumen within the tubing and the skin of a patient, and wherein the pressure sensor shields at least a portion of the tubing from puncture by a needle by virtue of the pressure sensor comprising a puncture-resistant material.

44. The system of claim 41, wherein the pressure transfer fluid contains no fillers having a negative coefficient of thermal expansion.

45. The system of claim 41, wherein the pressure transfer fluid contains no fillers having a coefficient of thermal expansion lower than the coefficient of thermal expansion of the pressure transfer fluid.

46. The system of claim 41, wherein the pressure sensor is configured to withstand steam sterilization without damage to the sensing element.

47. The system of claim 41, wherein the pressure sensor is configured to withstand a temperature in excess of 120 degrees Celsius without damage to the sensing element.

48. A method of retrofitting a tubing-based pressure sensor to a previously implanted gastric banding system, the method comprising:

removing a portion of existing tubing from the gastric banding system;

inserting a portion of new tubing into the gastric banding system, wherein the portion of the new tubing contains at least one pressure sensor disposed at least partially therein, and wherein the pressure sensor comprises;

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 a fluid within the tubing;

a pressure transfer fluid located within the cavity;

a sensing element, 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 pressure sensor; and

coupling the portion of the new tubing to at least one of;

a previously implanted access port, a previously implanted pump, or a portion of the existing tubing.

49. The method of claim 48, wherein the pressure sensor is disposed between a lumen within the portion of new tubing and the skin of a patient, and wherein the pressure sensor shields at least a portion of the new tubing from puncture by a needle by virtue of the pressure sensor comprising a puncture-resistant material.

50. The method of claim 48, wherein the pressure sensor is configured to withstand steam sterilization without damage to the pressure sensor.

51. The method of claim 48, wherein the steam sterilization is conducted at a temperature in excess of 120 degrees Celsius.