Devices and methods for attaching an endolumenal gastrointestinal implant

• US 20060020247A1
• Filed: 05/05/2005
• Published: 01/26/2006
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Dann, Mitchell, Guterman, Lee, Swain, Paul, Fallin, T. Wade, Butters, Joshua, Kagan, Jonathan, Baldwin, Thomas
• Granted Patent: US 8,070,743 B2
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61F 2/04 : Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/044 : Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0036 : Intragastrical devices
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

The present invention provides devices and methods for attachment of an endoluminal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve device or an attachment cuff, within a patient'"'"'s digestive tract for treatment of obesity.

Claims

1. A method of treating a patient, comprising the steps of:

providing a gastrointestinal sleeve device having an elongate tubular body, with a proximal end and a distal end;

positioning the gastrointestinal sleeve device in the patient'"'"'s digestive tract such that the proximal end of the tubular body is positioned in the vicinity of the gastroesophageal junction to receive ingested material from the patient'"'"'s esophagus and the distal end of the tubular body is positioned in the patient'"'"'s intestine; and

securing the proximal end in the vicinity of the gastroesophageal junction by advancing at least one attachment device through an adjacent tissue wall from the lumen of the stomach, to an outer serosal surface, and positioning a transverse retention surface on the attachment device in contact with the serosal surface.

2. A method of treating a patient as in claim 1, wherein the securing step comprises advancing at least six tissue anchors through the tissue wall and positioning a retention surface on each tissue anchor in contact with the serosal surface.

3. A method of treating a patient as in claim 1, wherein the securing step comprises advancing at least ten tissue anchors through the tissue wall and positioning a retention surface on each tissue anchor in contact with the serosal surface.

4. A method of treating a patient as in claim 1, wherein the tissue anchor comprises a connecting element for connecting the transverse retention surface to the sleeve device, and the length of the connecting element is at least about 75% of the uncompressed wall thickness.

5. A method of treating a patient as in claim 4, wherein the length of the connecting element is at least about 95% of the uncompressed wall thickness.

6. A method of treating a patient as in claim 4, wherein the length of the connecting element is at least about 125% of the uncompressed wall thickness.

7. A method of treating a patient as in claim 1, wherein the positioning the gastrointestinal sleeve step is accomplished with the use of an endoscope.

8. A method of treating a patient as in claim 1, wherein at least a portion of a wall of the tubular body is porous.

9. A method of treating a patient as in claim 1, wherein the tubular body is impermeable such that the tubular body acts as an internal intestinal bypass.

10. A method of treating a patient as in claim 1, wherein the providing step comprises providing the tubular body with a stoma in the vicinity of the proximal end.

11. A method of treating a patient as in claim 1, wherein the positioning step comprises positioning the tubular body such that the distal end is positioned at least as far as the patient'"'"'s jejunum.

12. A method of treating a patient as in claim 1, wherein the positioning step comprises positioning the tubular body such that the distal end is positioned at least about 100 cm past the pyloris.

13. A method of treating a patient as in claim 1, wherein the providing step comprises providing a sleeve having a substantially constant diameter throughout its length.

14. A method of treating a patient as in claim 1, wherein the providing step comprises providing a sleeve having a funnel-shaped entry on the proximal end.

15. A method of treating a patient, comprising the steps of:

providing a gastrointestinal attachment cuff having a tubular body, a proximal end and a distal end;

positioning the gastrointestinal cuff in the patient'"'"'s digestive tract adjacent a mucosal side surface in the vicinity of the gastroesophageal junction, the mucosal surface separated from a serosal surface by a wall thickness; and

securing the gastroesophageal cuff adjacent the mucosal surface by advancing at least three attachment structures through the mucosal surface, across the wall thickness and through the serosal surface to position a transverse retention surface of each attachment structure in contact with the serosal surface.

16. A method of treating a patient as in claim 15, wherein the securing step comprises advancing at least six attachment structures through the mucosal surface and positioning a retention surface of each attachment structure in contact with the serosal surface.

17. A method of treating a patient as in claim 16, wherein the securing step comprises advancing at least ten attachment structures through the mucosal surface and positioning a retention surface of each attachment structure in contact with the serosal surface.

18. A method of treating a patient as in claim 15, wherein the attachment structure comprises a connector element for connecting the transverse retention surface to the cuff, and the length of the connector element is at least about 75% of the uncompressed wall thickness between the mucosal surface and the serosal surface.

19. A method of treating a patient as in claim 18, wherein the length of the connector element is at least about 95% of the wall thickness.

20. A method of treating a patient as in claim 18, wherein the length of the connector element is at least about 125% of the wall thickness.

21. A method of treating a patient as in claim 15, further comprising the steps of providing an elongate flexible gastric bypass tube having a proximal end and a distal end, and attaching the proximal end to the cuff.

22. A method of treating a patient as in claim 21, wherein the attaching the proximal end of the bypass tube to the cuff step is accomplished with the use of an endoscope.

23. A method of treating a patient as in claim 21, wherein the attaching the proximal end of the bypass tube to the cuff step comprises removeably attaching the proximal end of the bypass tube to the cuff.

24. A method of treating a patient as in claim 15, wherein the tubular body is impermeable such that the tubular body acts as an internal intestinal bypass.

25. A method of treating a patient as in claim 21, comprising positioning the distal end of the bypass tube in the patient'"'"'s jejunum.

26. A method of treating a patient as in claim 21, comprising positioning the distal end of the bypass tube in the patient'"'"'s ileum.

27. A method of attaching a device to the mucosal side of a wall comprising a muscularis layer and a serosal layer, comprising the steps of:

providing a tension element having a retention element thereon;

advancing the retention element through the wall from the mucosal side and placing the retention element such that it is spaced apart from the muscularis by serosal tissue;

causing changes to the serosal tissue in between the retention element and the muscularis; and

attaching the device to the tension element, such that the device is positioned adjacent the mucosal surface.

28. A method of attaching a device to the mucosal side of a wall as in claim 27, wherein the causing changes to the serosal tissue step is accomplished following the attaching step.

29. A method of attaching a device to the mucosal side of a wall as in claim 27, wherein the causing changes to the serosal tissue step is accomplished prior to the attaching step.

30. A method of attaching a device to the mucosal side of a wall as in claim 28, wherein the causing changes to the serosal tissue step is in response to tension on the tension element biasing the retention element against the serosal surface.

31. A method of attaching a device to the mucosal side of a wall as in claim 27, wherein the causing changes to the serosal tissue step is in response to the application of an active agent.

32. A method of attaching a device to the mucosal side of a wall as in claim 31, comprising applying a sclerosing agent to the serosal tissue.

33. A method of attaching a device to the mucosal side of a wall as in claim 31, comprising applying a growth factor to the serosal tissue.

34. An attachment system for attaching a device to the mucosal side of a wall of the gastrointestinal tract, the wall comprising a muscularis layer and a serosal layer, the system comprising:

a gastrointestinal attachment cuff having a tubular body, a proximal end and a distal end;

at least one tissue anchor for transmural attachment of the cuff to the mucosal side, the anchor comprising a tension element for extending through the wall and at least one transverse retention surface for positioning in contact with serosal tissue.

35. An attachment system as in claim 34, wherein the tension element comprises suture.

36. An attachment system as in claim 34, wherein the tension element comprises a proximal end for extending through the mucosal layer and a distal end for carrying the transverse retention surface, wherein the transverse retention surface comprises a proximal surface of a serosal anchor.

37. An attachment system as in claim 36, wherein the serosal anchor comprises a T-tag.

38. An attachment system as in claim 36, wherein the serosal anchor comprises a disc.

39. An attachment system as in claim 36, wherein the serosal anchor is inflatable.

40. An attachment system as in claim 36, wherein the serosal anchor is transformable from a first, reduced profile for distal transmural advance through the wall, and a second, enlarged profile for resisting proximal retraction through the wall.

41. An attachment system as in claim 36, wherein the tension element has a length between the cuff and the transverse transverse retention surface, and the length is at least about 6 mm.

42. An attachment system as in claim 36, wherein the tension element has a length between the cuff and the transverse transverse retention surface, and the length is at least about 10 mm.

43. An attachment system as in claim 34, further comprising a first coupler on the attachment cuff for coupling to a second, complementary coupler on a gastric bypass tube.

44. An attachment system as in claim 43, wherein the first and second couplers are configured for removably coupling the bypass tube to the cuff.

45. An attachment system as in claim 43, wherein the first and second couplers are configured for permanently coupling the bypass tube to the cuff.

46. An attachment system as in claim 34, further comprising a gastric bypass tube for connection to the cuff, the bypass tube having a length of at least about 50 cm.

47. An attachment system as in claim 34, comprising at least six tissue anchors.

48. An attachment system as in claim 34, comprising at least ten tissue anchors.

49. A method of adjusting therapy in a patient, comprising the steps of:

identifying a patient with an implanted first gastrointestinal bypass tube having a first length, the first bypass tube releasably connected to a support which is attached to tissue in the vicinity of the gastroesophageal junction;

separating the first bypass tube from the support and removing the first bypass tube from the patient;

providing a second bypass tube, having a second length which is different than the first length; and

attaching the second bypass tube to the support.

50. A method of adjusting therapy in a patient as in claim 49, wherein the second length is longer than the first length.

51. A method of adjusting therapy in a patient as in claim 49, wherein the second length is shorter than the first length.

52. A method of adjusting therapy in a patient as in claim 49, wherein the attaching step is accomplished endoscopically.