DEPLOYMENT SYSTEM FOR INTRALUMINAL DEVICES

• US 20040073286A1
• Filed: 01/22/2001
• Published: 04/15/2004
• 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 (W.L. Gore and Associates)
• Inventors: Cully, Edward H., Vonesh, Michael J., Ulm, Mark J., Shaw, Edward E., Armstrong, Joseph P.
• Granted Patent: US 6,899,727 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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.

Claims

1. An endoprosthesis assembly comprising:

an endoprosthesis capable of being diametrically expanded from a smaller diameter to a larger diameter; and

a generally tubular 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.

2. An endoprosthsis assembly according to claim 1 wherein the distending force results from inflation of a catheter balloon.

3. An endoprosthesis assembly according to claim 1 wherein the means for disruption comprises perforations.

4. An endoprosthesis assembly according to claim 3 wherein the perforations are oriented in at least one substantially straight line substantially parallel to a longitudinal axis of the generally tubular constraining sheath.

5. An endoprosthesis assembly according to claim 3 wherein the perforations are arranged in a line which is not parallel to a longitudinal axis of the generally tubular constraining sheath.

6. An endoprosthesis assembly according to claim 1 wherein the sheath comprises porous expanded polytetrafluoroethylene.

7. An endoprosthesis assembly according to claim 6 wherein the porous expanded polytetrafluoroethylene comprises porous expanded polytetrafluoroethylene film.

8. An endoprosthesis assembly according to claim 7 wherein the porous expanded polytetrafluoroethylene film is applied in layers wherein one layer extends around less than an entire circumference of the constraining sheath.

9. An endoprosthesis assembly according to claim 7 wherein the constraining sheath has a full length, wherein the porous expanded polytetrafluoroethylene film is applied in layers wherein one layer extends for less than the full length of the constraining sheath.

10. An endoprosthesis assembly according to claim 1 wherein the means for disruption comprises a seamline.

11. An endoprosthesis assembly according to claim 1 wherein the constraining sheath has one end affixed to a catheter shaft.

12. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is implantable.

13. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is removable following deployment of the endoprosthesis.

14. An endoprosthesis assembly according to claim 1 wherein said endoprosthesis comprises a stent provided with a distensible stent covering.

15. An endoprosthesis assembly according to claim 1 wherein the constraining sheath contains a therapeutic agent releasable following deployment.

16. An endoprosthesis assembly according to claim 1 wherein said constraining sheath has two adjacent rows of perforations, wherein disruption is initiated by applying tension to a pull string affixed to a tip end of a portion of the constraining sheath located between the two adjacent rows of perforations.

17. An endoprosthesis assembly according to claim 1 wherein said constraining sheath and endoprosthesis each have a length, and wherein disruption is initiated by moving an object through at least a portion of the length of the endoprosthesis and constraining sheath, said object having a larger diameter than the smaller diameter of the endoprosthesis.

18. An endoprosthesis assembly according to claim 1 wherein the endoprosthesis has first and second ends, wherein only the first end is expanded to the larger diameter.

19. An endoprosthesis assembly according to claim 18 wherein the endoprosthesis is an occluder.

20. An endoprosthesis assembly according to claim 18 wherein the endoprosthesis is a filter.

21. An endoprosthesis assembly according to claim 18 wherein the second end of the endoprosthesis is expanded at a later time to the larger diameter.

22. An endoprosthesis assembly according to claim 1 wherein the means for disruption comprises a hinge.

23. An endoprosthesis assembly according to claim 1 wherein the constraining sheath contains a radiopaque marker.

43. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is implantable.

44. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is removable following deployment of the endoprosthesis.

45. An endoprosthesis assembly according to claim 1 wherein said endoprosthesis comprises a stent provided with a distensible stent covering.

46. An endoprosthesis assembly according to claim 1 wherein the constraining sheath contains a radiopaque marker.

24. A constraining sheath comprising a tubular form, for use coaxially around an endoprosthesis having a first, smaller circumference intended to allow insertion into a body conduit having a luminal surface and a second, larger circumference to which it may be deployed within the body conduit to contact the luminal surface of the body conduit, said constraining sheath fitted coaxially around the endoprosthesis at the first, smaller circumference, said constraining sheath having means for disruption initiated by application of a distending force to the constraining sheath, wherein disruption of the constraining sheath results in deployment of the endoprosthesis to the second, larger circumference.

25. A constraining sheath according to claim 24 wherein the distending force results from inflation of the catheter balloon.

26. A constraining sheath according to claim 24 wherein the means for disruption comprises perforations.

27. A constraining sheath according to claim 26 wherein the perforations are oriented in at least one substantially straight line substantially parallel to a longitudinal axis of the generally tubular constraining sheath.

28. A constraining sheath according to claim 26 wherein the perforations are arranged in a line which is not parallel to a longitudinal axis of the generally tubular constraining sheath.

29. A constraining sheath according to claim 24 wherein the sheath comprises porous expanded polytetrafluoroethylene.

30. A constraining sheath according to claim 29 wherein the porous expanded polytetrafluoroethylene comprises porous expanded polytetrafluoroethylene film.

31. A constraining sheath according to claim 30 wherein the porous expanded polytetrafluoroethylene film is applied in layers wherein one layer extends around less than an entire circumference of the constraining sheath.

32. A constraining sheath according to claim 30 wherein the constraining sheath has a full length, wherein the porous expanded polytetrafluoroethylene film is applied in layers wherein one layer extends for less than the full length of the constraining sheath.

33. A constraining sheath according to claim 24 wherein the means for disruption comprises a seamline.

34. A constraining sheath according to claim 24 wherein the constraining sheath has one end affixed to a catheter shaft.

35. A constraining sheath according to claim 24 wherein the constraining sheath contains a therapeutic agent releasable following deployment.

36. A constraining sheath according to claim 24 having two adjacent rows of perforations, wherein disruption is initiated by applying tension to a pull string affixed to a tip end of a portion of the constraining sheath located between the two adjacent rows of perforations.

37. A constraining sheath according to claim 24 wherein said constraining sheath and endoprosthesis each have a length, and wherein disruption is initiated by moving an object through at least a portion of the length of the endoprosthesis and constraining sheath, said object having a larger diameter than the smaller diameter of the endoprosthesis.

38. A constraining sheath according to claim 24 wherein the endoprosthesis has first and second ends, wherein only the first end is expanded to the larger diameter.

39. A constraining sheath according to claim 38 wherein the endoprosthesis is an occluder.

40. A constraining sheath according to claim 38 wherein the endoprosthesis is a filter.

41. A constraining sheath according to claim 38 wherein the second end of the endoprosthesis is expanded at a later time to the larger diameter.

42. A constraining sheath according to claim 24 wherein the means for disruption comprises a hinge.

47. An endoprosthesis assembly comprising:

an endoprosthesis capable of being diametrically expanded from a smaller circumference to a larger circumference; and

a generally tubular constraining sheath provided around the endoprosthesis at the smaller circumference of the endoprosthesis, said constraining sheath having a larger circumference of similar dimension to the larger circumference to which the endoprosthesis can be diametrically expanded, extra material of the constraining sheath forming at least one flap that is wrapped around the smaller circumference of the endoprosthesis and temporarily bonded to temporarily constrain the endoprosthesis at the smaller circumference.

48. An endoprosthesis assembly according to claim 47 wherein inflation of the catheter balloon provides a distending force resulting in disruption of the at least one temporarily bonded flap of the constraining sheath, thereby allowing the endoprosthesis to deploy to the larger circumference.

49. An endoprosthesis assembly according to claim 47 wherein the at least one flap is temporarily bonded with a medical grade adhesive.

50. An endoprosthesis assembly according to claim 47 wherein the at least one flap is temporarily bonded with a thermal bond.

51. An endoprosthesis assembly according to claim 47 wherein the constraining sheath comprises porous polytetrafluoroethylene

52. An endoprosthesis assembly according to claim 47 wherein the constraining sheath is implantable.

53. An endoprosthesis assembly according to claim 47 wherein the constraining sheath is removable with the catheter balloon following deployment of the endoprosthesis.

54. An endoprosthesis assembly according to claim 47 wherein the endoprosthesis contains a therapeutic agent that is releasable following deployment of the endoprosthesis.