Eversion resistant sleeves

• US 7,766,973 B2
• Filed: 06/08/2005
• Issued: 08/03/2010
• Est. Priority Date: 01/19/2005
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Parker, Ian, Melanson, David A., Levine, Andy H.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/147,984
• Publication Number:
  US 20060161187A1
• Time in Patent Office: 1,882 Days
• Field of Search: 623 2364- 2368, 623 124- 126, 623 112- 113, 623/23.7, 623/2.14, 623/2.18, 604/8
• US Class Current: 623/23.7
• 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:

a proximal anchor adapted for attachment within a natural body lumen;

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

an eversion-resistant feature of the sleeve disposed only at the proximal end of the sleeve that inhibits eversion of the sleeve by collapsing radially in the presence of retrograde pressures, the floppy zone of the sleeve extending the substantial length of the sleeve beyond the eversion resistant feature, the eversion-resistant feature comprising;

a proximal crumple zone of the sleeve that collapses radially in the presence of retrograde pressures; and

a distal reinforced region of the sleeve between the crumple zone and the floppy zone of the sleeve, the reinforced region collapsing radially, but to a lesser extent than the crumple zone, 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, 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.

11. 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.

12. The device of claim 1, wherein the device has a concentric eversion pressure of at least 30 inches H₂O.

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

providing an eversion-resistant feature of a thin-walled sleeve only at a proximal end of the sleeve, the eversion-resistant feature having an eversion-threshold pressure greater than that of the sleeve itself, a floppy zone of the sleeve extending a substantial length of the sleeve beyond the eversion-resistant feature;

anchoring, with an anchor, the proximal end of the sleeve with the eversion-resistant feature in the lumen;

focusing collapse of the eversion-resistant feature towards the longitudinal axis of the anchor by radially collapsing a proximal crumple zone of the sleeve in the presence of retrograde pressures; and

radially collapsing a distal reinforcing region of the sleeve coupled to the proximal crumple zone of the sleeve in the presence of retrograde pressures, the distal reinforcing region collapsing to a lesser extent than the proximal crumple zone.

14. The method of claim 13, further comprising the steps of increasing the stiffness of a proximal portion of the thin-walled, floppy sleeve.

15. The method of claim 14, wherein the step of increasing the stiffness comprises providing a different material relatively stiffer than the sleeve.

16. The method of claim 14, wherein the step of increasing the stiffness comprises providing more than one layer of material.

17. The method of claim 16, wherein the step of increasing the stiffness comprises coupling a reinforcing member to the proximal end of the sleeve.

18. The method of claim 13, further comprising the steps of increasing the coefficient of friction along an exterior surface a proximal portion of the thin-walled, floppy sleeve.

19. The method of claim 18, wherein the step of increasing the coefficient of friction comprises providing a different material.

20. The method of claim 18, wherein the step of increasing the coefficient of friction comprises texturing the exterior surface.

21. The method of claim 13, 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.

22. 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 sleeve open at both ends and defining a lumen therebetween, a floppy zone of the sleeve having material characteristics that result in the sleeve being prone to evert proximally to the anchor;

eversion resisting means of the sleeve for resisting eversion of any portion of the sleeve proximally to the anchoring means by collapsing radially in the presence of retrograde pressures, the eversion resisting means being disposed only at a proximal end of the sleeve, a floppy zone of the sleeve extending a substantial length of the sleeve beyond the eversion resisting means,

the eversion resisting means comprising;

a proximal crumple zone of the sleeve that collapses radially in the presence of retrograde pressures; and

a distal reinforcing region of the sleeve coupled to the crumple zone, the reinforcing means collapsing radially, but to a lesser extent than the crumple zone, in the presence of retrograde pressures.

23. 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;

an eversion-resistant feature disposed between the anchor and the proximal end of the sleeve that inhibits eversion of the sleeve by collapsing radially in the presence of retrograde pressure,

the eversion-resistant feature comprising;

a proximal crumple zone of the sleeve that collapses in the presence of retrograde pressures; and

a distal reinforced region of the sleeve between the crumple zone and the substantial length of the sleeve, the reinforcing means collapsing, but to a lesser extent than the crumple zone, in the presence of retrograde pressures.

24. The device of claim 23, 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.

25. The device of claim 23, wherein the device has a concentric eversion pressure of at least 30 inches H₂O.