Gastrointestinal anchor compliance

• US 20070005147A1
• Filed: 06/08/2005
• Published: 01/04/2007
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: Gidynamics, Inc.
• Original Assignee: GI Dynamics Incorporated
• Inventors: Levine, Andy, Melanson, David
• Granted Patent: US 7,976,488 B2
• Time in Patent Office: Days
• US Class Current: 623/23.650
• 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 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

A collapsible gastrointestinal anchor can be characterized in various embodiments by a radial force of about 0.1 Newtons (N) or greater at a compressed diameter of 25 millimeters (mm); by an average spring rate of about 13 Newtons/meter (N/m) or greater in a range of motion between a relaxed diameter and a compressive elastic deformation diameter; or by a radial force over the range of motion of about 0.1 N or greater. Typically, the anchor can be adapted to be retained within a subject'"'"'s intestine, more typically in the duodenum, or particularly in the duodenal bulb just distal to the pylorus. A gastrointestinal implant device includes the collapsible gastrointestinal anchor and a floppy sleeve. The sleeve is open at both ends and adapted to extend into a subject'"'"'s intestine, the anchor being coupled to a proximal portion of the sleeve. Also include are methods of implanting the gastrointestinal implant device in a subject, and methods of treating a subject for disease. The disclosed gastrointestinal invention leads to an improved ability to secure anchors and devices in the gastrointestinal tract while tending to minimize migration.

Claims

1-19. -19. (canceled)

20. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends and adapted to extend into a subject'"'"'s intestine; and

a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterized by a radial force of about 0.1 Newtons (N) or greater at a compressed diameter of 25 millimeters (mm).

21. The gastrointestinal implant device of claim 20, the radial force at 25 mm being measured while unloading the anchor from a compressed state.

22. The gastrointestinal implant device of claim 20, the radial force at 25 mm being about 0.3 N or greater.

23. The gastrointestinal implant device of claim 20, characterized by a relaxed diameter of about 40 mm or greater.

24. The gastrointestinal implant device of claim 20, characterized by a relaxed diameter of between about 45 mm and about 65 mm.

25. The gastrointestinal implant device of claim 20, the radial force being about 0.2 N or greater over a range of motion of about 20 mm or greater, the range of motion being between a relaxed diameter and a compressive elastic deformation diameter.

26. The gastrointestinal implant device of claim 20, further comprising barbs.

27. The gastrointestinal implant device of claim 20, characterized by a compressive elastic deformation diameter of about 12 mm or less.

28. The gastrointestinal implant device of claim 20, the anchor being made of Nitinol wire.

29. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends and adapted to extend into a subject'"'"'s intestine; and

a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterized by an average spring rate of about 13 Newtons/meter (N/m) or greater in a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter.

30. The gastrointestinal implant device of claim 29, the spring rate being measured while unloading the anchor from a compressed state.

31. The gastrointestinal implant device of claim 29, characterized by a relaxed diameter of about 40 mm or greater.

32. The gastrointestinal implant device of claim 29, the average value of the spring rate being between about 15 N/m and about 35 N/m.

33. The gastrointestinal implant device of claim 29, the range of motion being about 30 mm or greater.

34. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends and adapted to extend into a subject'"'"'s intestine; and

a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterized by a radial force of about 0.1 Newtons (N) or greater over a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter.

35. The gastrointestinal implant device of claim 34, the radial force being measured while unloading the anchor from a compressed state.

36. The gastrointestinal implant device of claim 34, the radial force being about 0.2 N.

37. The gastrointestinal implant device of claim 34, characterized by a relaxed diameter of about 40 mm or greater.

38. The gastrointestinal implant device of claim 34, the range of motion being about 30 mm or greater.

39-59. -59. (canceled)

60. A gastrointestinal implant device, comprising:

a flexible sleeve; and

collapsible anchor means for providing substantially constant force against gastrointestinal tissue over a range of motion occurring between a relaxed diameter of about 40 mm or greater and a compressive elastic deformation diameter of the anchor.