Deployment system for intraluminal devices

• US 20020099431A1
• Filed: 01/22/2002
• Published: 07/25/2002
• Est. Priority Date: 01/22/2001
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Cully, Edward H., Armstrong, Joseph R., Vonesh, Michael J., Ulm, Mark J.
• Granted Patent: US 6,827,731 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter. The angioplasty balloon'"'"'s working length is preferably shorter than the length of the endoprosthesis. A endoprosthesis assembly incorporating a constraining sheath according to one embodiment of the invention is also provided with an additional packaging sheath.

Claims

1. An endoprosthesis assembly comprising an implantable endoprosthesis capable of being diametrically expanded from a smaller diameter to a larger diameter;

and a generally tubular, delicate constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, said constraining sheath being provided with means for disruption initiated by application of a distending force to the constraining sheath, wherein said assembly is contained within a packaging sheath which is not required to be implantable.

2. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 21 hours.

3. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 24 hours.

4. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 48 hours .

5. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 5 days.

6. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 10 days.

7. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 20 days.

8. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 30 days.

9. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 45 days.

10. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 60 days.

11. An endoprosthesis assembly according to claim 1 wherein the endoprosthesis is a self-expanding endoprosthesis.

12. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 21 hours.

13. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 24 hours.

14. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 48 hours.

15. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 5 days.

16. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 10 days.

17. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 20 days.

18. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 30 days.

19. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 45 days.

20. An endoprosthesis assembly according to claim 11 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 60 days.

21. An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath comprises porous expanded polytetrafluoroethylene.

22. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 21 hours.

23. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 24 hours.

24. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 48 hours.

25. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 5 days.

26. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 10 days.

27. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 20 days.

28. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 30 days.

29. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 45 days.

30. An endoprosthesis assembly according to claim 21 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 60 days.

31. An endoprosthesis assembly according to claim 21 wherein the endoprosthesis is a self-expanding endoprosthesis.

32. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 21 hours.

33. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 24 hours.

34. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 48 hours.

35. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 5 days.

36. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 10 days.

37. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 20 days.

38. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 30 days.

39. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 45 days.

40. An endoprosthesis assembly according to claim 31 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60°

C. for a time of at least 60 days.

41. An endoprosthesis assembly comprising an implantable endoprosthesis capable of being diametrically expanded from a smaller diameter to a larger diameter;

and a generally tubular, delicate constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, said constraining sheath being provided with means for disruption initiated by application of a distending force to the constraining sheath, wherein said assembly is stored at a temperature of less than about 5°

C. for at least 30 days.

42. An endoprosthesis assembly according to claim 41 wherein the assembly is stored at a temperature of less than about 5°

C. for at least 60 days.

43. An endoprosthesis assembly comprising a catheter balloon having a working length, an implantable endoprosthesis having a length and capable of being diametrically expanded from a smaller diameter to a larger diameter;

said endoprosthesis being fitted coaxially over the catheter balloon with the length of the endoprosthesis approximately centered axially over the working length of the catheter balloon, and a generally tubular constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, wherein the working length of the catheter balloon is less than the length of the endoprosthesis.

44. An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 90 percent of the length of the endoprosthesis or less.

45. An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 80 percent of the length of the endoprosthesis or less.

46. An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 70 percent of the length of the endoprosthesis or less.

47. An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 60 percent of the length of the endoprosthesis or less.

48. An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 50 percent of the length of the endoprosthesis or less.