Eversion resistant sleeves

• US 20060161187A1
• Filed: 06/08/2005
• Published: 07/20/2006
• Est. Priority Date: 01/19/2005
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Coval-Goldsmith, Sherrie, Melanson, David A., Levine, Andy H., Parker, Ian
• Granted Patent: US 7,766,973 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

The invention relates to improved means for preventing eversion and subsequent obstruction of thin-walled, floppy gastrointestinal liners implanted in the digestive tract of an animal. The implantable devices include an anchor adapted for attachment within a natural body lumen and a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween. A substantial length of the sleeve has material characteristics that result in the sleeve being prone to eversion in the presence of retrograde pressures. Exemplary eversion-resistant features provide an increased stiffness and/or an increased friction coefficient between the anchor and the proximal end of the sleeve to resist eversion. In some embodiments, the eversion-resistant feature includes an anti-buckling element, such as a wire coupled along the substantial length of the sleeve.

Claims

1. A device for implanting within an animal body comprising:

an anchor adapted for attachment within a natural body lumen;

a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween, a substantial length of the sleeve having material characteristics that result in the sleeve being prone to eversion; and

an eversion-resistant feature disposed between the anchor and the proximal end of the sleeve that inhibits eversion of the sleeve in the presence of retrograde pressures.

2. The device of claim 1, wherein the eversion-resistant feature comprises increased stiffness relative to the sleeve'"'"'s stiffness.

3. The device of claim 2, wherein the increased stiffness is provided by a different material than that of the sleeve.

4. The device of claim 2, wherein the increased stiffness is provided by an increased wall thickness of the same material relative to that of the sleeve.

5. The device of claim 4, wherein the increased wall thickness comprises more than one layer of material.

6. The device of claim 2, wherein the increased stiffness is provided by a reinforcing member.

7. The device of claim 1, wherein a surface of the eversion-resistant feature has a coefficient-of-friction greater than that of a corresponding surface of the sleeve.

8. The device of claim 7, wherein the eversion-resistant feature comprises a different material having a coefficient of friction greater than that of the thin-walled, floppy sleeve.

9. The device of claim 7, wherein at least a portion of the exterior surface of the eversion-resistant feature is textured.

10. The device of claim 1, further comprising a centering element adapted to focus collapse of the eversion-resistant element towards the longitudinal axis of the anchor.

11. The device of claim 10, wherein the centering element comprises:

a proximal crumple zone; and

a distal reinforcing element coupled to the crumple zone, the crumple zone collapsing before the reinforcing element in the presence of retrograde pressures.

12. The device of claim 11, wherein the crumple zone comprises a tapered cone defining a proximal opening having a first diameter and a distal opening having a second diameter less than the first, a sufficient retrograde pressure moving the distal opening proximally while inhibiting lateral movement towards the walls of the body lumen.

13. The device of claim 1, wherein the eversion-resistant element is adapted to partially collapse upon itself thereby forming a valve allowing flow in an antegrade direction, while prohibiting flow in a retrograde direction thereby blocking eversion of the sleeve.

14. A method for inhibiting eversion of a sleeve device when implanted within a natural body lumen comprising:

providing an eversion-resistant feature at a proximal end of a thin-walled, floppy sleeve, the eversion-resistant feature having an eversion-threshold pressure greater than that of the sleeve itself, and

anchoring the proximal end of the sleeve with eversion-resistant feature in the lumen.

15. The method of claim 14, further comprising the steps of increasing the stiffness of a proximal portion of the thin-walled, floppy sleeve.

16. The method of claim 15, wherein the step of increasing the stiffness comprises providing a different material relatively stiffer than the sleeve.

17. The method of claim 15, wherein the step of increasing the stiffness comprises providing more than one layer of material.

18. The method of claim 17, wherein the step of increasing the stiffness comprises coupling a reinforcing member to the proximal end of the sleeve.

19. The method of claim 14, further comprising the steps of increasing the coefficient of friction along an exterior surface a proximal portion of the thin-walled, floppy sleeve.

20. The method of claim 19, wherein the step of increasing the coefficient of friction comprises providing a different material.

21. The method of claim 19, wherein the step of increasing the coefficient of friction comprises texturing the exterior surface.

22. The method of claim 14, further comprising the step of focusing collapse of the eversion-resistant element towards the longitudinal axis of the anchor in the presence of retrograde pressures to inhibit eccentric eversions.

23. The method of claim 14, further comprising the step of inducing a partial collapse of the eversion-resistant element upon itself, thereby forming a valve allowing flow in an antegrade direction, while prohibiting flow in a retrograde direction in the presence of retrograde pressures.

24. A device for implanting within an animal body comprising:

means for anchoring a proximal end of the device within a natural body lumen, the device including an elongated, thin-walled, floppy sleeve open at both ends and defining a lumen therebetween, a substantial length of the sleeve having material characteristics that result in the sleeve being prone to evert proximally to the anchor; and

means for resisting eversion of any portion of the sleeve proximally to the anchoring means in the presence of retrograde pressures.

25. A device for implanting within an animal body comprising:

an anchor adapted for attachment within a natural body lumen;

a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween, a substantial length of the sleeve having material characteristics that result in the sleeve being prone to eversion; and

an eversion-resistant feature disposed along a substantial length of the sleeve adapted to inhibit eversion of the sleeve in the presence of retrograde pressures.

26. The device of claim 25, wherein increased stiffness is provided by an anti-buckling member.

27. The device of claim 26, wherein the anti-buckling member is a wire coupled to the sleeve.

28. A device for implanting within an animal body comprising:

an anchor adapted for attachment within the small intestine of an animal body;

a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween and adapted to extend within the small intestine, a substantial length of the sleeve having material characteristics that result in the sleeve being prone to eversion; and

an eversion-resistant feature that inhibits eversion of the sleeve in the presence of retrograde pressures.

29. The device of claim 28, wherein the eversion-resistant feature is disposed between the anchor and a proximal, non-insubstantial length of the thin-walled, floppy sleeve.

30. The device of claim 28, wherein the eversion-resistant feature extends along a substantial length of the thin-walled, floppy sleeve.

31. The device of claim 30, wherein the eversion-resistant feature comprises an anti-buckling member.

32. The device of claim 31, wherein the anti-buckling member includes a wire.

33. The device of claim 28, wherein a relaxed diameter of the anchor is at least about 40 mm.