Deployment system for an endoluminal device

• US 20040143315A1
• Filed: 08/08/2003
• Published: 07/22/2004
• Est. Priority Date: 01/17/2003
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Cully, Edward H., Vonesh, Michael J., Ulm, Mark J., Bruun, Steven R., Mann, James W.
• Granted Patent: US 7,753,945 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

The present invention is directed to a deployment system for an endoluminal device. The deployment system includes a confining sheath placed around a compacted endoluminal device. A deployment line is provided in the system that is an integral extension of the sheath. As the deployment line is actuated, the sheath retracts from around the compacted endoluminal device. As the sheath retracts from around the endoluminal device, material from the sheath may be converted into deployment line. Once the sheath is retracted from around the compacted endoluminal device, the endoluminal device expands in configuration and repairs vascular or cardiac structures of an implant recipient. Any remaining sheath material is removed from the implantation site along with the deployment line. The deployment system also includes an endo-prosthesis mounting member placed between the endoluminal device and an underlying catheter. The endo-prosthesis mounting member serves to cushion and retain the endoluminal device when constrained by the sheath and may assist in expansion of the endoluminal device when unconstrained by the sheath.

Claims

1. A deployment system for an endoluminal device comprising:

an expandable endoluminal device mounted on a delivery catheter provided With an endo-prosthesis mounting member;

a removable sheath adapted to cover the endoluminal device, the sheath comprising a fluoropolymer material adapted to surround at least a portion of the endoluminal device and constrain the device in an introductory profile;

wherein the deployment system includes a deployment line integral with the sheath to effectuate device deployment; and

wherein upon deployment, the sheath separates from the endoluminal device through actuation of the deployment line, the sheath becoming removed from the device along with the deployment line.

2. The deployment system of claim 1 wherein the sheath comprises an extruded thin-walled tube.

3. The deployment system of claim 1 wherein the sheath comprises a thin continuous film.

4. The deployment system of claim 1 wherein the sheath is in the form of an extruded thin-walled tube reinforced with a thin continuous film tube.

5. The deployment system of claim 1 wherein the sheath confines an endo-prosthesis mounting member to a smaller profile on the delivery catheter than an endo-prosthesis mounting member without the sheath.

6. The deployment system of claim 1 wherein the sheath splits to transform from the sheath to an elongated filament.

7. The deployment system of claim 6 wherein means is provided to aid in splitting from a sheath to the filament.

8. The deployment system of claim 6 wherein the means to aid in splitting comprises a splitter.

9. The deployment system of claim 6 wherein the means to aid in splitting comprises an engineered defect incorporated into the sheath-deployment line.

10. The deployment system of claim 1 wherein the sheath comprises a wall with a thickness of less than 0.05 mm.

11. The deployment system of claim 1 wherein the sheath comprises a fluoropolymer that surrounds the endoluminal device in a double layer.

12. The deployment system of claim 10 wherein one layer of the double layer is placed over the other layer and one layer moves past the other layer upon deployment.

13. The deployment system of claim 1 wherein the system includes a single catheter shaft.

14. The deployment system of claim 1 wherein actuation of the deployment line is achieved at least in part with an active elastic element incorporated therein.

15. The deployment system of claim 13 wherein the catheter shaft extends distally beyond the endoluminal device in its introductory profile.

16. The deployment system of claim 1 further comprising at least a portion of a second catheter co-axially placed over at least a portion of said delivery catheter.

17. The deployment system of claim 16 wherein said at least a portion of a second catheter substantially confines said sheath-deployment line.

18. The deployment system of claim 1 wherein the endo-prosthesis mounting member is in the form of an inflatable balloon.

19. The deployment system of claim 1 wherein the endoprosthesis mounting member is non-inflatable.

20. The deployment system of claim 18 wherein the inflatable balloon includes polytetrafluoroethylene.

21. The deployment system of claim 1 wherein the length of sheath retracted from the self-expanding endoluminal device is substantially equal to the length of deployment line displaced during deployment of the self-expanding endoluminal device.

22. The deployment system of claim 1 wherein the length of sheath retracted from the self-expanding endoluminal device is essentially half the length of deployment line displaced during deployment of the self-expanding endoluminal device.

23. The deployment system of claim 1 wherein the sheath is not attached to a catheter shaft.

24. A deployment system for an endoluminal device comprising:

an expandable endoluminal device placed over an endo-prosthesis mounting member and at least partially enclosed by a removable sheath; and

a deployment line integral with the removable sheath, wherein the removable sheath is convertible to the deployment line as the sheath is removed from the endoluminal device.

25. The deployment system of claim 24 wherein the sheath is in the form of an extruded thin-walled tube.

26. The deployment system of claim 24 wherein the sheath is in the form of a thin continuous film.

27. The deployment system of claim 24 wherein the sheath is in the form of an extruded thin-walled tube reinforced with a thin continuous film tube.

28. The deployment system of claim 24 wherein the sheath confines an endo-prosthesis mounting member to a smaller profile on the delivery catheter than an endo-prosthesis mounting member without the sheath.

29. The deployment system of claim 24 wherein the removable sheath is split to convert the sheath to the deployment line.

30. The deployment system of claim 24 wherein the sheath comprises a continuous film that surrounds the endoluminal device in a double layer.

31. The deployment system of claim 24 wherein the sheath comprises an extruded fluoropolymer tube that surrounds the endoluminal device in a double layer.

32. The deployment system of claim 30 wherein the sheath is convertible to deployment line over at least a portion of the sheath length.

33. The deployment system of claim 24 further comprising a catheter placed within the endo-prosthesis mounting member.

34. The deployment system of claim 24 wherein the endo-prosthesis mounting member is in the form of an inflatable balloon.

35. The deployment system of claim 34 wherein the inflatable balloon includes polytetrafluoroethylene.

36. The deployment system of claim 24 wherein the endo-prosthesis mounting member is non-inflatable.

37. The deployment system of claim 33 wherein the catheter has a single lumen.

38. The deployment system of claim 24 further comprising at least a portion of a second catheter co-axially placed over at least a portion of said delivery catheter.

39. The deployment system of claim 38 wherein said at least a portion of a second catheter substantially confines said sheath-deployment line.

40. The deployment system of claim 33 further comprising means on the catheter for initiating conversion of the removable sheath to the deployment line.

41. The deployment system of claim 24 wherein the removable sheath is split by the means to initiate conversion of the removable sheath to the deployment line.

42. The deployment system of claim 24 wherein the removable sheath is made of a polymeric material.

43. The deployment system of claim 42 wherein the polymeric material includes a fluoropolymer.

44. The deployment system of claim 43 wherein the fluoropolymer is polytetrafluoroethylene.

45. The deployment system of claim 44 wherein the polytetrafluoroethylene is porous expanded polytetrafluoroethylene.

46. The deployment system of claim 45 wherein the porous expanded polytetrafluoroethylene is in the form of a tube.

47. The deployment system of claim 46 wherein the tube has a wall with a thickness of less than 0.05 mm.

48. The deployment system of claim 24 wherein a first portion of the removable sheath substantially surrounds at least a portion of the self-expanding endoluminal device and a second portion of the removable sheath substantially covers the first portion.

49. The deployment system of claim 48 wherein the deployment line is integral with the second portion of the removable sheath.

50. The deployment system of claim 24 wherein the sheath is not attached to a catheter shaft.