Deployment system for an endoluminal device

• US 7,753,945 B2
• Filed: 08/08/2003
• Issued: 07/13/2010
• 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: Bruun, Steven R., Mann, James W., Cully, Edward H., Vonesh, Michael J., Ulm, Mark J.
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/637,986
• Publication Number:
  US 20040143315A1
• Time in Patent Office: 2,531 Days
• Field of Search: 623/1.11, 606/108, 606/198, 606/194, 606/195
• 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 in the form of a continuous double-walled tube adapted to cover and constrain at least a portion of said endoluminal device in an introductory profile;

wherein said deployment system includes a deployment line integral with and extending from one wall of said double-walled tube to which tension can be applied to aid endoluminal device deployment;

wherein upon endoluminal device deployment, said double-walled tube progressively unrolls from around said endoluminal device through actuation of said deployment line to form removed sheath material;

wherein said removed sheath material begins to become converted to deployment line at a point where said removed sheath material breaks apart, separates, and converges into deployment line material in the form of an elongated filament; and

wherein said converged deployment line material is removed from said deployment system along with said deployment line.

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

3. The deployment system of claim 1 wherein said double-walled tube comprises a thin continuous film.

4. The deployment system of claim 1 wherein said double-walled tube 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 comprises a wall with a thickness of less than 0.05 mm.

7. The deployment system of claim 1 wherein the sheath comprises a fluoropolymer.

8. The deployment system of claim 1 wherein one wall of said double-walled tube is placed over the other wall and one wall moves past the other wall upon unrolling of said double-walled tube.

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

10. The deployment system of claim 9 wherein the catheter shaft extends distally beyond the endoluminal device in its introductory profile.

11. 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.

12. 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.

13. The deployment system of claim 12 wherein said at least a portion of a second catheter substantially confines said sheath-deployment line.

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

15. The deployment system of claim 14 wherein the inflatable balloon includes polytetrafluoroethylene.

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

17. The deployment system of claim 1 wherein the length of sheath retracted from the expandable endoluminal device is essentially half the length of deployment line displaced during deployment of the expandable endoluminal device.

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

19. 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;

wherein said removable sheath comprises a polymeric material in the form of a continuous double thin-walled tube adapted to surround at least a portion of the expandable endoluminal device and constrain the expandable endoluminal device in an introductory profile on the endo-prosthesis mounting member;

an extension of the double thin-walled tube in the form of a filamentous deployment line, wherein the deployment line extension is integral and continuous with the double thin-walled tube; and

wherein upon actuation of the deployment line, the double thin-walled tube unrolls from the endoluminal device and converts from the double thin-walled tube to form to a single elongated deployment line filament.

20. The deployment system of claim 19 wherein said double-walled tube comprises an extruded thin-walled tube.

21. The deployment system of claim 19 wherein wherein said double-walled tube comprises a thin continuous film.

22. The deployment system of claim 19 wherein said double-walled tube is in the form of an extruded thin-walled tube reinforced with a thin continuous film tube.

23. The deployment system of claim 19 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.

24. The deployment system of claim 19 wherein the sheath comprises an extruded fluoropolymer tube.

25. The deployment system of claim 19 wherein the sheath is convertible to deployment line over at least a portion of the sheath length.

26. The deployment system of claim 19 further comprising a catheter placed within the endo-prosthesis mounting member.

27. The deployment system of claim 19 wherein the endo-prosthesis mounting member is in the form of an inflatable balloon.

28. The deployment system of claim 27 wherein the inflatable balloon includes polytetrafluoroethylene.

29. The deployment system of claim 19 wherein the endo-prosthesis mounting member is non-inflatable.

30. The deployment system of claim 26 wherein the catheter has a single lumen.

31. The deployment system of claim 19 further comprising at least a portion of a second catheter co-axially placed over at least a portion of said delivery catheter.

32. The deployment system of claim 31 wherein said at least a portion of a second catheter substantially confines said sheath-deployment line.

33. The deployment system of claim 19 wherein the polymeric material includes a fluoropolymer.

34. The deployment system of claim 33 wherein the fluoropolymer is polytetrafluoroethylene.

35. The deployment system of claim 34 wherein the polytetrafluoroethylene is porous expanded polytetrafluoroethylene.

36. The deployment system of claim 35 wherein the tube has a wall with a thickness of less than 0.05 mm.

37. The deployment system of claim 19 wherein a first portion of the removable sheath substantially surrounds at least a portion of the expandable endoluminal device and a second portion of the removable sheath substantially covers the first portion.

38. The deployment system of claim 37 wherein the deployment line is integral with the second portion of the removable sheath.

39. The deployment system of claim 19 wherein the sheath is not attached to a catheter shaft.