SELF-ADJUSTING GASTRIC BAND

• US 20120095288A1
• Filed: 05/31/2011
• Published: 04/19/2012
• Est. Priority Date: 04/29/2010
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Snow, Sean, Babkes, Mitchell H., Borrell, Marcos, Dominguez, Zachary P., Franklin, Ethan, Honaryar, Babak, Torjesen, Erik, Deuel, Christopher R.
• Application Number:
  US13/149,585
• Publication Number:
  US 20120095288A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61F 5/0063 wrapping the stomach

Abstract

Generally described herein are automatic, self-adjusting, gastric banding systems and improvements thereof, that are capable of automatically relaxing and contracting in response to a large bolus passing through the area of a patient'"'"'s stomach constricted by a gastric band. Alternatively, and/or in addition in one or more embodiments, the gastric banding systems described herein may also help prevent pouch dilatation and/or erosion. The apparatus and systems described herein aid in facilitating obesity control and/or treating obesity-related diseases while generally being non-invasive once implanted. Furthermore, certain embodiments of the self-adjusting gastric banding systems disclosed herein are automatically adjustable without complicated fluid control mechanisms, flow rate limiting devices, and/or valves. The automatic adjustments may also be made in response to other changes in the patient'"'"'s esophageal-gastric junction, for example, in response to size, shape, and or location changes.

Claims

1. A self-adjusting gastric banding system for the treatment of obesity that adjusts to allow a bolus to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric banding system, the self-adjusting gastric banding system comprising:

a gastric band having an inflatable portion disposed about the stomach of the patient, the inflatable portion capable of constricting the stomach;

an access port fluidly coupled to the inflatable portion, the access port capable of receiving a fluid to inflate, or for removing a fluid to deflate, the inflatable portion of the gastric band;

a tubing coupled to the gastric band and the access port, the tubing carrying fluid between the inflatable portion of the gastric band and the access port; and

a compliant reservoir attached to at least a portion of the tubing and configured to receive fluid from the inflatable portion of the gastric band for automatically relaxing the constriction formed by the inflatable portion of the gastric band sufficiently to allow the bolus to pass through the constriction.

2. The self-adjusting gastric banding system of claim 1 wherein the tubing traverses through an interior cavity of the compliant reservoir.

3. The self-adjusting gastric banding system of claim 1 wherein the tubing includes an open portion, the entirety of the open portion located within the compliant reservoir, the open portion configured to allow fluid to flow into and out of the compliant reservoir.

4. The self-adjusting gastric banding system of claim 1 wherein the tubing includes a portion having a plurality of openings, and each of the openings fully located within the compliant reservoir for allow fluid to flow into and out of the compliant reservoir.

5. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir is a tube-shaped cylinder having a star-shaped structure defining an outer circumference, the star-shaped structure being deformable in response to an increase in fluid volume in the compliant reservoir.

6. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir is a tube-shaped cylinder configured to expand in diameter at a mid-point of the cylinder in response to an increase in fluid volume in the compliant reservoir.

7. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir is a flattened tube configured to expand in response to an increase in fluid volume in the compliant reservoir.

8. The self-adjusting gastric banding system of claim 7 wherein the flattened tube further includes indented portions which expand in response to the increase in fluid volume in the compliant reservoir.

9. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir is a u-shaped tube having two u-shaped portions, the u-shaped tube configured to expand in response to a first increase in fluid volume in the compliant reservoir such that one of the two u-shaped portions becomes flat, while the other of the two u-shaped portions remains u-shaped, the u-shaped tube configured to expand in response to a second increase in fluid volume in the complaint reservoir such that the u-shaped tube is transformed into a substantially oval tube.

10. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir includes a compliant tube and an exterior shell, the exterior shell configured to circumferentially surround the compliant tube while leaving a gap between an outer surface of the compliant tube and an inner surface of the exterior shell.

11. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir comprises a plurality of coiled wings, each of the coiled wings having a preset stress and being configured to uncoil and straighten out in response to an increase in fluid within the compliant reservoir.

12. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir may include an internal spring configured to prevent the compliant reservoir from being kinked, bent or compressed disrupting a flow of fluid through the compliant reservoir.

13. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir may include an internal cage configured to prevent the compliant reservoir from being kinked, bent or compressed disrupting a flow of fluid through the compliant reservoir.

14. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir may include a plurality of internal, parallel rings configured to prevent the compliant reservoir from being kinked, bent or compressed disrupting a flow of fluid through the compliant reservoir.

15. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir may include an external structure wrapping axially about the compliant reservoir, the external structure being deformable in response to the compliant reservoir having a fluid volume exceeding a threshold, the external structure further having a hinge cut.

16. The self-adjusting gastric banding system of claim 1 wherein the compliant reservoir may include depressions along an outer circumferential perimeter, the depressions configured to buckle inward in a reproducible manner when suction is applied to the compliant reservoir.

17. The self-adjusting gastric banding system of claim 1 further comprising a ring configured to surround an entirety of the inflatable portion, further wherein the compliant reservoir surrounds an outer perimeter of the ring.

18. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient;

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion;

a tubing coupled to the inflatable portion and the access port, the tubing for carrying fluid between the inflatable portion and the access port; and

a compliant reservoir coupled to the access port at a first end and being closed at a second end, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction.

19. The self-adjusting gastric band of claim 18 wherein the compliant reservoir is a coiled tube having a preset stress, the coiled tube configured to uncoil and straighten out in response to an increase in fluid within the compliant reservoir.

20. The self-adjusting gastric band system of claim 18 wherein the compliant reservoir is tube having a bulged reservoir at the second end, the bulged reservoir configured to enlarge in response to an increase in fluid within the compliant reservoir.

21. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable member configured to inflate when fluid is introduced into the inflatable member and deflate when fluid is removed from the inflatable member, the inflatable member configured to be situated about an esophageal-gastric junction of the patient;

an access port fluidly coupled to the inflatable portion to inflate and deflate the inflatable portion; and

a plurality of compliant reservoirs radially oriented about the inflatable portion, and fluidly coupled to the inflatable portion and the access port, the plurality of compliant reservoirs for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion.

22. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient, the inflatable portion configured to be filled with a pseudoplastic fluid or a Bingham plastic;

an access port coupled to the inflatable portion to fill and drain the inflatable portion of the pseudoplastic fluid or the Bingham plastic; and

a compliant reservoir coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving the pseudoplastic fluid or the Bingham plastic from the inflatable portion.

23. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

a plurality of closed constriction portions disposed about an esophageal-gastric junction for contacting and restricting the patient'"'"'s stomach; and

a support structure attached to the plurality of closed constriction portions, the support structure including alternating ring portions and hinge portions, each ring portion contacting a different one of the plurality of closed constriction portions, each hinge portion separating adjacent ring portions, and configured to flex to allow the large bolus to pass through the constriction.

24. The self-adjusting gastric band of claim 23 wherein the plurality of closed constriction portions are filled with gas and wherein the plurality of closed constriction portions are each coated with a gas-impermeable substance.

25. The self-adjusting gastric band of claim 23 wherein the plurality of closed constriction portions are filled with a fluid.

26. The self-adjusting gastric band of claim 23 further comprising four constriction portions, four ring portions and four hinges.

27. A gas-impermeable self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the gas-impermeable self-adjusting gastric band, the gas-impermeable self-adjusting gastric band comprising:

a gas-impermeable inflatable portion disposable about an esophageal-gastric junction of the patient;

a gas-impermeable access port fluidly coupled to the inflatable portion to fill and drain the gas-impermeable inflatable portion; and

a gas-impermeable compliant reservoir fluidly coupled to the gas-impermeable inflatable portion and the gas-impermeable access port, the gas-impermeable compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving gas from the gas-impermeable inflatable portion.

28. The gas-impermeable self-adjusting gastric band of claim 27 wherein the gas-impermeable inflatable portion, the gas-impermeable access port and the gas-impermeable compliant reservoir are each coated with a gas-impermeable substance.

29. The gas-impermeable self-adjusting gastric band of claim 27 wherein at least one of the gas-impermeable inflatable portion, the gas-impermeable access port and the gas-impermeable compliant reservoir is constructed out of silicone rubber.

30. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient;

a reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving both fluid and gas from the inflatable portion; and

an encapsulated gas-filled member configured to move from the inflatable portion to the reservoir in response to a pressure created by the large bolus passing through the constriction, the encapsulated gas-filled member further configured to move from the reservoir to the inflatable portion in response to a reduction of pressure when the large bolus has passed through the constriction.

31. The self-adjusting gastric band of claim 30 wherein the encapsulated gas-filled member is a balloon coated with a gas-impermeable coating.

32. The self-adjusting gastric band of claim 30 wherein the encapsulated gas-filled member is a closed-cell foam coated with a gas-impermeable coating.

33. The self-adjusting gastric band of claim 30 wherein the reservoir is compliant.

34. The self-adjusting gastric band of claim 30 wherein the reservoir is rigid.

35. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient;

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion;

a reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion; and

a gas spring located within the reservoir, the gas spring having a housing and a piston, the gas spring configured to move the piston within the housing in a direction away from the inflatable portion and compress a gas sealed between the inside walls of the housing and the piston in response to a pressure created by the large bolus.

36. The self-adjusting gastric band of claim 35 wherein the gas spring is configured to move the piston toward the inflatable portion and decompress the gas in response to a reduction of pressure caused by the large bolus passing through the constriction.

37. The self-adjusting gastric band of claim 36 further comprising a pin configured to stop the movement of the piston in response to the reduction of pressure caused by the large bolus passing through the constriction.

38. The self-adjusting gastric band of claim 35 wherein the outer surface of the housing comprises alternating curved portions and flat portions, the curved portions for contacting an interior surface of the reservoir and holding the housing in place, the flat portions for allowing the fluid to pass through the reservoir between the interior surface of the reservoir and the outer surface of the housing.

39. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient; and

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion, the access port further configured to be a compliant member for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion.

40. The self-adjusting gastric band of claim 39 wherein the access port further comprises a movable membrane which increases the fluid volume of the access port in response to a pressure induced by the large bolus passing through the constriction.

41. The self-adjusting gastric band of claim 39 wherein the access port further comprises a permeable membrane having openings configured to allow fluid to pass through while preventing a tip of a needle from passing through.

42. The self-adjusting gastric band of claim 39 wherein the access port further comprises a spring.

43. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient;

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion;

a compliant reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion; and

a restriction device for controlling a fluid flow rate between the inflatable portion and the compliant reservoir, the restriction device configured to temporarily increase the band-side pressure when a large bolus passes through the constriction.

44. The self-adjusting gastric band of claim 43 wherein the restriction device is a one-way valve, a pressure relief valve, an orifice, a turbulence controller, a sponge, or an environment adapting device.

45. The self-adjusting gastric band of claim 43 wherein the restriction device is electronically controlled, modulated with an external adjustment system or a passive restriction device configured to be independent from being controlled by an external tool.

46. The self-adjusting gastric band of claim 43 wherein the restriction device is an orifice having an inner diameter which limits the flow rate of the fluid in both directions.

47. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction, the inflatable portion having a first end and a separate second end; and

a ring about the inflatable portion, the ring constructed out of metal and having a spring rate that provides a substantially constant force on the esophageal-gastric junction of the patient where the inflatable portion is disposed, the ring further configured to flex open to allowing the large bolus to pass through the constriction.

48. The self-adjusting gastric band of claim 47 further comprising a tether for connecting the first end and the second end.

49. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient, the inflatable portion having a first component for restricting and stimulating the esophageal-gastric junction, and a second component for dilation prevention, the second component attached to the first component in an orad direction, the second component increasing in diameter in the orad direction; and

a ring about the inflatable portion, the ring having a first component corresponding with the first component of the inflatable portion and a second component corresponding with the second component of the inflatable portion, the second component of the ring attached to the first component of the ring in an orad direction, the second component increasing in diameter in the orad direction.

50. The self-adjusting gastric band of claim 49 further comprising:

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion; and

a compliant reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion.

51. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient, the inflatable portion independent from a ring portion and structural support for the inflatable portion solely dependent on the inflatable portion;

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion; and

a compliant reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion.

52. A self-adjusting gastric band that adjusts to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the self-adjusting gastric band, the self-adjusting gastric band comprising:

an inflatable portion disposable about an esophageal-gastric junction of the patient;

a ring attached to the inflatable portion, the ring having a plurality of indented portions along a length of the ring;

an access port fluidly coupled to the inflatable portion to fill and drain the inflatable portion; and

a compliant reservoir fluidly coupled to the inflatable portion and the access port, the compliant reservoir for automatically relaxing the constriction formed by the self-adjusting gastric band and allowing the large bolus to pass through the constriction by receiving fluid from the inflatable portion.

53. The self-adjusting gastric band of claim 52 wherein the indented portions are holes which extend through the entire depth of the ring.

54. The self-adjusting gastric band of claim 52 wherein each of the indented portions include two tapered surfaces.

55. A vacuum device configured to assist a patient in transferring fluid from a gastric band to a fluidly coupled reservoir to allow a large bolus of food to pass through a constriction in a patient'"'"'s stomach formed by the gastric band, the vacuum device comprising:

a body having a suction-creating component; and

a tip attached to the body, the tip configured to have a diameter substantially equal to a diameter of the reservoir, the tip configured to contact an area on an outer surface of the patient'"'"'s body proximate to the location of the reservoir and form a seal on the contacted area to pull on skin of the patient and a subcutaneous fat layer located below the skin to induce fluid to flow from the gastric band to the reservoir.