Implantable artificial partition and methods of use

• US 20030093117A1
• Filed: 11/04/2002
• Published: 05/15/2003
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid
• Granted Patent: US 7,160,312 B2
• Time in Patent Office: Days
• US Class Current: 606/221
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/2945 : Curved jaws
• CPC Class Codes: A61B 2018/00023 : closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00083 : low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00273 : Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00369 : Heart valves
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4238 : stomach
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Apparatus and methods are provided for partitioning a gastro-intestinal lumen by intraluminally reducing a local cross-sectional area thereof. The apparatus comprises a plurality of anchors adapted for intraluminal penetration into a wall of the gastro-intestinal lumen to prevent migration or dislodgement of the apparatus, and a partition, which may include a drawstring or a toroidal balloon, coupled to the plurality of anchors to provide a local reduction in the cross-sectional area of the gastro-intestinal lumen.

Claims

1. Apparatus for partitioning a gastrointestinal lumen defined by a lumen wall, comprising:

a plurality of anchors configured to intraluminally penetrate into the lumen wall, each one of the plurality of anchors providing a fixture point; and

a partition coupled to the fixture point of each one of the plurality of anchors, the partition providing a localized reduction in a cross-sectional area of the GI lumen.

2. The apparatus of claim 1, wherein at least one of the plurality of anchors comprises a substrate having a multiplicity of barbs.

3. The apparatus of claim 1, wherein at least one of the plurality of anchors comprises a barbed distal end.

4. The apparatus of claim 1, wherein at least one of the plurality of anchors comprises a re-configurable member expandable from a reduced delivery profile to an expanded profile.

5. The apparatus of claim 4, wherein the re-configurable member comprises a plurality of struts.

6. The apparatus of claim 5, wherein the plurality of struts are covered by a membrane.

7. The apparatus of claim 4, wherein the re-configurable member comprises an elongated shaft that assumes a coiled shape when deployed to the expanded profile.

8. The apparatus of claim 1, wherein at least one of the plurality of anchors comprises an enclosure containing a water-swellable gel.

9. The apparatus of claim 1, wherein the partition comprises a biocompatible drawstring defining a stoma.

10. The apparatus of claim 9, wherein a cross-sectional area of the stoma is adjustable.

11. The apparatus of claim 1, wherein the partition comprises a toroidal balloon defining a stoma.

12. The apparatus of claim 11, wherein a diameter of the stoma is adjustable.

13. The apparatus of claim 12, wherein the diameter of the stoma is configured to be hydraulically adjusted.

14. The apparatus of claim 12, wherein the toroidal balloon further comprises a re-sealable port through which an inflation medium may be injected to adjust the diameter of the stoma.

15. The apparatus of claim 12, further comprising a pump and a reservoir coupled in fluid communication with the toroidal balloon.

16. The apparatus of claim 12, further comprising an inflation port coupled in fluid communication with the toroidal balloon, wherein the diameter of the stoma may be adjusted via introduction of an inflation medium through the inflation port.

17. The apparatus of claim 16, wherein the inflation port is configured for subcutaneous implantation.

18. The apparatus of claim 16, wherein the inflation port is configured to dynamically adjust the diameter of the stoma responsive to the pressure of food in the GI lumen proximal to an upper surface of the toroidal balloon.

19. The apparatus of claim 1, further comprising:

an internal control unit configured for subcutaneous implantation and operably coupled to the partition;

an external control unit that emits wireless signals for receipt by the internal control unit.

20. The apparatus of claim 12, wherein the diameter of the stoma is configured to be mechanically adjusted.

21. The apparatus of claim 12, wherein the toroidal balloon further comprises a substantially annular band having an adjustable diameter, the substantially annular band disposed around the stoma.

22. The apparatus of claim 21, wherein the substantially annular band comprises a shape memory alloy.

23. The apparatus of claim 21, wherein the substantially annular band comprises a worm, the apparatus further comprising a worm gear operably engaged to the worm, and a motor mechanically coupled to the worm gear.

24. The apparatus of claim 12, wherein the toroidal balloon further comprises a plurality of ultrasound transducers disposed around the stoma for measurement of the diameter of the stoma.

25. The apparatus of claim 12, wherein the toroidal balloon further comprises a conductive band having an adjustable length and a resistance that varies responsive to the adjustable length of the conductive band, the conductive band disposed around the stoma to measure the diameter of the stoma.

26. The apparatus of claim 12, wherein a pressure within the toroidal balloon varies responsive to the diameter of the stoma.

27. The apparatus of claim 26, wherein the toroidal balloon further comprises a pressure sensor that provides pressure data for wireless transmission, the pressure data corresponding to the pressure within the toroidal balloon.

28. The apparatus of claim 11, wherein the toroidal balloon is configured to create a seal against the lumen wall upon inflation thereof.

29. The apparatus of claim 28, wherein the toroidal balloon further comprises a plurality of concavities.

30. The apparatus of claim 29, wherein the plurality of anchors are coupled to the toroidal balloon so that the lumen wall is pulled into the plurality of concavities when the toroidal balloon is inflated.

31. The apparatus of claim 11, wherein the toroidal balloon further comprises a membrane that constrains outward radial expansion of the toroidal balloon.

32. The apparatus of claim 31, wherein the membrane further constrains proximal and distal expansion of the toroidal balloon.

33. The apparatus of claim 1, further comprising a cuff configured for attachment to the lumen wall proximal to the plurality of anchors and the partition, and to direct food in the GI lumen to pass through a stoma defined by the partition.

34. The apparatus of claim 1, further comprising a plurality of latches configured to couple the partition to the fixture point of each one of the plurality of anchors.

35. A method for partitioning a gastrointestinal lumen defined by a lumen wall, the method comprising:

providing apparatus having a plurality of anchors and a partition configured to be coupled to the plurality of anchors;

delivering the apparatus into the gastro-intestinal lumen;

engaging the plurality of anchors to the lumen wall; and

actuating the partition so that a local cross-sectional area of the gastro-intestinal lumen is reduced.

36. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein at least one of the plurality of anchors comprises a substrate having a multiplicity of barbs; and

engaging the plurality of anchors comprises penetrating the lumen wall with the multiplicity of barbs.

37. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein at least one of the plurality of anchors comprises a barbed distal end; and

engaging the plurality of anchors comprises penetrating the lumen wall with the barbed distal end.

38. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein at least one of the plurality of anchors comprises a re-configurable member expandable from a reduced delivery profile to an expanded profile; and

engaging the plurality of anchors comprises penetrating the lumen wall with the re-configurable member in the reduced delivery profile, and expanding the re-configurable member into the expanded profile.

39. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein at least one of the plurality of anchors comprises an enclosure containing a water-swellable gel; and

engaging the plurality of anchors comprises penetrating the lumen wall with the enclosure, and permitting the water-swellable gel to expand within the enclosure.

40. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein each one of the plurality of anchors comprises a fixture point, and the partition comprises a biocompatible drawstring; and

actuating the partition comprises tightening the biocompatible drawstring through the fixture point of each one of the plurality of anchors to define a stoma.

41. The method of claim 40, the method further comprising adjusting a cross-sectional area of the stoma.

42. The method of claim 35, wherein:

providing apparatus comprises providing apparatus wherein the partition comprises a toroidal balloon; and

actuating the partition comprises inflating the toroidal balloon.

43. The method of claim 42, wherein the toroidal balloon defines a stoma;

and

the method further comprising adjusting a diameter of the stoma.

44. The method of claim 43, wherein adjusting a diameter of the stoma comprises hydraulically adjusting the diameter of the stoma.

45. The method of claim 43, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a re-sealable port; and

adjusting a diameter of the stoma comprises injecting an inflation medium through the re-sealable port.

46. The method of claim 43, wherein providing apparatus comprises providing apparatus further comprising a pump and a reservoir coupled in fluid communication with the toroidal balloon;

and

adjusting a diameter of the stoma comprises inducing the pump to adjust a volume of fluid within the reservoir.

47. The method of claim 43, wherein:

providing apparatus further comprises providing apparatus having an inflation port coupled in fluid communication with the toroidal balloon; and

adjusting a diameter of the stoma comprises introducing an inflation medium through the inflation port.

48. The method of claim 47, further comprising subcutaneously implanting the inflation port.

49. The method of claim 35, wherein providing apparatus comprises providing apparatus further comprising an internal control unit configured for subcutaneous implantation and operably coupled to the partition, and an external control unit adapted to emit wireless signals for receipt by the internal control unit;

and

the method further comprising inducing the external control unit to emit wireless signals to the internal control unit.

50. The method of claim 43, wherein adjusting a diameter of the stoma comprises mechanically adjusting the diameter of the stoma.

51. The method of claim 43, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a substantially annular band having an adjustable diameter, the substantially annular band disposed around the stoma; and

adjusting a diameter of the stoma comprises adjusting the adjustable diameter of the substantially annular band.

52. The method of claim 51, wherein providing apparatus comprises providing apparatus wherein the substantially annular band comprises a shape memory alloy;

and

adjusting the adjustable diameter of the substantially annular band comprises inducing the substantially annular band to undergo a phase transition.

53. The method of claim 51, wherein providing apparatus comprises providing apparatus wherein the substantially annular band comprises a worm, the apparatus further comprising a worm gear operably engaged to the worm, and a motor mechanically coupled to the worm gear;

and

adjusting the adjustable diameter of the substantially annular band comprises inducing the motor to rotate the worm.

54. The method of claim 43, further comprising measuring the diameter of the stoma.

55. The method of claim 54, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a plurality of ultrasound transducers disposed around the stoma; and

measuring the diameter of the stoma comprises detecting the time-of-flight of signals traveling between pairs of the plurality of ultrasound transducers.

56. The method of claim 54, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a conductive band having an adjustable length and a resistance that varies responsive to the adjustable length of the conductive band, the conductive band disposed around the stoma; and

measuring the diameter of the stoma comprises measuring the resistance of the conductive band.

57. The method of claim 54, wherein:

providing apparatus comprises providing apparatus wherein a pressure within the toroidal balloon varies responsive to the diameter of the stoma; and

measuring the diameter of the stoma comprises detecting the pressure within the toroidal balloon.

58. The method of claim 57, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a pressure sensor; and

detecting the pressure within the toroidal balloon comprises inducing the pressure sensor to obtain pressure data for wireless transmission.

59. The method of claim 42, further comprising creating a seal between the toroidal balloon and the lumen wall.

60. The method of claim 59, wherein:

providing apparatus comprises providing apparatus wherein the toroidal balloon further comprises a plurality of concavities; and

inflating the toroidal balloon comprises inducing the lumen wall to be pulled into the plurality of concavities.

61. The method of claim 42, wherein inflating the toroidal balloon comprises constraining outward radial expansion of the toroidal balloon.

62. The method of claim 61, wherein inflating the toroidal balloon further comprises constraining proximal and distal expansion of the toroidal balloon.

63. The method of claim 35, wherein providing apparatus further comprises providing apparatus having a cuff;

and

the method further comprising attaching the cuff to the lumen wall proximal to the plurality of anchors and the partition so that food is directed in the GI lumen to pass through a stoma defined by the partition.

64. The method of claim 35, further comprising latching the partition to the plurality of anchors.