Implantable medical device assembly

• US 20040122503A1
• Filed: 12/20/2002
• Published: 06/24/2004
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Campbell, Carey V., Wiley, William H.
• Granted Patent: US 6,984,242 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

The present invention is directed to implantable medical device assemblies. The assemblies are primarily used to introduce and deposit implantable medical devices in the vasculatures of implant recipients. The principle implantable medical device used in the assembly is an expandable element in the form of an endovascular device. The expandable element is maintained in a compacted configuration during introduction of the device into the vasculature with a confinement means. The expandable element is released from the confinement means at an implantation site with a control line. The control line has high tensile strength, high modulus, structural rigidity, and low compressibility. These features of the control line provide a practitioner with tactile feedback of the release of the expandable element from the confinement means. The tactile feedback is present during the entire deployment of the expandable element. The tactile feedback enables the practitioner to better track and control deployment of the expandable element at an implantation site.

Claims

1. An implantable medical device assembly comprising:

an expandable element;

at least one control line removably attached to the implantable medical device assembly;

the control line comprising a non-fluoropolymer core and a fluoropolymer cover surrounding the core.

2. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by pull through force of greater than about 4.

3. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by pull through force of greater than about 5.

4. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by pull through force of greater than about 6.

5. The implantable medical device assembly of claim 1 wherein said implantable medical device assembly further comprises confinement means containing said expandable element in a compacted configuration.

6. The implantable medical device assembly of claim 5 wherein the control line is removably attached to the confinement means.

7. The implantable medical device assembly of claim 6 wherein the control line is removably attached to the confinement means by stitching.

8. The implantable medical device assembly of claim 7 wherein the control line provides tactile feedback to a practitioner as essentially every stitch is removed from said confinement means.

9. The implantable medical device assembly of claim 1 wherein the expandable element comprises a vascular device.

10. The implantable medical device assembly of claim 9 wherein the vascular device is a stent.

11. The implantable medical device assembly of claim 10 wherein the stent has a permanent covering placed on at least a portion of the stent.

12. The implantable medical device assembly of claim 10 wherein the stent is an expandable stent.

13. The implantable medical device assembly of claim 12 wherein the expandable stent has a permanent covering placed on at least a portion of the stent.

14. The implantable medical device assembly of claim 9 wherein the vascular device is a stent-graft.

15. The implantable medical device assembly of claim 9 wherein the vascular device is an intra-cardiac device.

16. The implantable medical device assembly of claim 1 wherein the removable control line has a tensile strength of at least 14 pounds force.

17. The implantable medical device assembly of claim 1 wherein the core comprises an aramid polymer.

18. The implantable medical device assembly of claim 1 wherein the core comprises a liquid crystal polymer.

19. The implantable medical device assembly of claim 1 wherein the core comprises polyethyleneterephthalate.

20. The implantable medical device assembly of claim 1 wherein the core comprises polyamid.

21. The implantable medical device assembly of claim 1 wherein the fluoropolymer material comprises polytetrafluoroethylene.

22. The implantable medical device assembly of claim 21 wherein the polytetrafluoroethylene comprises porous polytetrafluoroethylene.

23. A medical device assembly comprising:

an implantable device;

at least one removable control line attached to the implantable device;

wherein the control line comprises a non-fluoropolymer core and a fluoropolymer material surrounding the core.

24. The medical device assembly of claim 23 wherein the implantable device is a vascular device.

25. The medical device assembly of claim 24 wherein the vascular device is a stent.

26. The medical device assembly of claim 25 wherein the stent has a permanent covering placed on at least a portion of the stent.

27. The medical device assembly of claim 25 wherein the stent is an expandable stent.

28. The medical device assembly of claim 27 wherein the expandable stent has a permanent covering placed on at least a portion of the stent.

29. The medical device assembly of claim 24 wherein the vascular device is a stent-graft.

30. The medical device assembly of claim 24 wherein the vascular device is an intra-cardiac device.

31. The medical device assembly of claim 23 wherein the removable control line has a tensile strength of at least 14 pounds force.

32. The medical device assembly of claim 23 wherein the core comprises an aramid polymer.

33. The medical device assembly of claim 23 wherein the core comprises a liquid crystal polymer.

34. The medical device assembly of claim 23 wherein the core comprises polyethyleneterephthalate.

35. The medical device assembly of claim 23 wherein the core comprises polyamid.

36. The medical device assembly of claim 23 wherein the fluoropolymer material comprises polytetrafluoroethylene.

37. The medical device assembly of claim 36 wherein the polytetrafluoroethylene comprises porous polytetrafluoroethylene.

38. A medical device assembly comprising:

an implantable device having a confinement means placed on at least a portion of the device;

at least one removable control line attached to the confinement means;

wherein the removable control line comprises a non-fluoropolymer core and a fluoropolymer material surrounding the core.

39. The medical device assembly of claim 38 wherein the confinement means substantially surrounds the device.

40. The medical device assembly of claim 39 wherein the confinement means is in the form of a sheet and is maintained around the device with stitches made with the removable control line.

41. The medical device assembly of claim 40 wherein tactile feedback is provided to a practitioner as the removable control line is pulled by the practitioner and the control line becomes unstitched from the confinement means.

42. The medical device assembly of claim 41 wherein the tactile feedback is in the form of oscillating pulling forces that vary in magnitude as substantially every stitch is removed from the confinement means.

43. The medical device assembly of claim 38 wherein the cover is removable from the implantable device.

44. The medical device assembly of claim 38 wherein the implantable device is a cardio-vascular device.

45. The medical device assembly of claim 44 wherein the cardio-vascular device is a stent.

46. The medical device assembly of claim 45 wherein the stent has a permanent covering placed on at least a portion of the stent.

47. The medical device assembly of claim 45 wherein the stent is an expandable stent.

48. The medical device assembly of claim 47 wherein the expandable stent has a permanent covering placed on at least a portion of the stent.

49. The medical device assembly of claim 44 wherein the vascular device is a stent-graft.

50. The medical device assembly of claim 44 wherein the vascular device is an intra-cardiac device.

51. The medical device assembly of claim 38 wherein the control line has a tensile strength of at least 14 pounds force.

52. The medical device assembly of claim 38 wherein the core comprises an aramid polymer.

53. The medical device assembly of claim 38 wherein the core comprises a liquid crystal polymer.

54. The medical device assembly of claim 38 wherein the core comprises polyethyleneterephthalate.

55. The medical device assembly of claim 38 wherein the core comprises polyamid.

56. The medical device assembly of claim 38 wherein the fluoropolymer material comprises polytetrafluoroethylene.

57. The medical device assembly of claim 56 wherein the polytetrafluoroethylene comprises porous polytetrafluoroethylene.