Methods and systems for cardiac valve delivery

• US 20070027534A1
• Filed: 07/24/2006
• Published: 02/01/2007
• Est. Priority Date: 07/27/2005
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Bergheim, Bjarne, Cuevas, Walter, DuMontelle, Jeffrey
• Granted Patent: US 8,790,396 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention provides systems and methods for the repair, removal, and/or replacement of heart valves. The methods comprise introducing a delivery system into the heart, wherein a prosthesis is disposed on the delivery member attached to the delivery system, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery member at the target site for implantation. The present invention also provides implant systems for delivering a prosthesis to a target site in or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system, and a prosthesis.

Claims

1. A balloon expandable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a balloon delivery member positioned about the distal end of the scapus;

a valve replacement detachably positioned about the balloon delivery member and capable of being collapsed so as to temporarily reduce the valve diameter by up to 90%; and

a collapsible stent positioned about the exterior of the valve, the collapsible stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts.

2. The stented valve replacement scapus delivery system of claim 1 wherein the stent is made of stainless steel.

3. The stented valve replacement scapus delivery system of claim 1 wherein the stent has three parallel support posts attached to the circular inflow and outflow rims at about 120°

intervals.

4. The stented valve replacement scapus delivery system of claim 1 wherein the scapus is a solid rod.

5. The stented valve replacement scapus delivery system of claim 1 wherein the scapus is a hollow rod.

6. The stented valve replacement scapus delivery system of claim 1 wherein the scapus is a catheter with a substantially rigid guide-stick loosely disposed within the said catheter.

7. The stented valve replacement scapus delivery system of claim 1 wherein the scapus is a catheter with a substantially rigid guide-sleeve loosely disposed around said catheter.

8. The stented valve replacement scapus delivery system of either claim 5 or 6, wherein the scapus material is a stainless steel or a polymer plastistic.

9. The stented valve scapus delivery system of claim 1 wherein the balloon delivery member further includes a perfusion tube connecting the distal and proximal ends of said balloon delivery member in order to allow blood flow through the perfusion tube.

10. The stented valve scapus delivery system of claim 1 wherein the stent commissural attachments are adapted to align with the commissural attachments of a previously implanted heart valve prosthesis.

11. A balloon expandable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a valve replacement detachably positioned about the balloon delivery member and capable of being collapsed so as to temporarily reduce the valve diameter by up to 90%; and

a collapsible stent positioned about the exterior of the valve, the collapsible stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts.

a first inflatable balloon delivery member positioned about the scapus at the distal end of the stented valve replacement, the first inflatable balloon delivery member, when inflated, having a larger diameter than the stented valve in order to prevent migration of the stented valve; and

a second inflatable balloon delivery member positioned about the scapus at the proximal end of the stented valve replacement, the second inflatable balloon delivery member, when inflated, having a larger diameter than the stented valve replacement in order to further prevent migration of the stented valve.

12. The stented valve replacement scapus delivery system of claim 11 wherein the stent is made of stainless steel.

13. The stented valve replacement scapus delivery system of claim 11 wherein the stent has three parallel support posts attached to the circular inflow and outflow rims at about 120°

intervals.

14. The stented valve scapus delivery system of claim 11 wherein the stented valve is circumferentially surrounded by a balloon delivery member middle portion that is operatively connected to the first and second inflatable balloon delivery members for simultaneous inflation.

15. The stented valve scapus delivery system of claim 11 wherein the first and second inflatable balloon delivery members have a larger coefficient of friction than the balloon delivery member middle portion.

16. The stented valve scapus delivery system of claim 11 wherein the delivery system further includes a perfusion tube positioned about the scapus, the perfusion tube being operatively connected to one or more holes in the distally mounted first inflatable balloon delivery member in order to allow blood flow through the perfusion tube.

17. The stented valve scapus delivery system of claim 11 wherein both the second inflatable balloon delivery member and the balloon delivery middle portion are also operatively connected to the perfusion tube in order to allow for blood flow.

18. The stented valve scapus delivery system of claim 11 wherein the scapus is a hollow rod containing one or more lumens within the hollow rod cavity.

19. A stented valve replacement delivery member comprising:

a balloon delivery member comprising a middle section and a proximal and distal end, wherein the cross-sectional areas of the distal and proximal ends of the inflated balloon are larger than the cross-sectional areas of the middle section of the inflated balloon; and

a valve replacement detachably positioned about the middle of the balloon delivery member and capable of being collapsed so as to temporarily reduce the valve diameter by up to 90%; and

a collapsible stent positioned about the exterior of the valve, the collapsible stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts.

20. The stented valve replacement delivery member of claim 19 wherein the balloon delivery member further includes a perfusion tube connecting the distal and proximal ends of said balloon delivery member in order to allow blood flow through the perfusion tube.

21. An intra-vascular embolic protection system consisting of a distal and proximal end, so as to operate, when expanded, as a temporary valve and prevent flush back of blood, embolic material and other debris comprising:

a compressible frame located at the proximal end of the intra-vascular embolic protection system that makes a seal with the surrounding vasculature;

a first compressible porous bag, having an open filter mouth at its proximal end and connected to the compressible frame, and whose distal end is open; and

a second compressible porous bag enveloping the first compressible porous bag, having an open filter mouth at its proximal end and connected to the compressible frame, and whose distal end is open.

22. The intra-vascular embolic protection system of claim 21 wherein the distal end of the second compressible porous bag is closed.

23. The intra-vascular embolic protection system of claim 21 wherein the intra-vascular embolic protection system is internally supported, when expanded, by a frame material of shape memory alloy.

24. The intra-vascular embolic protection system of claim 21, wherein the intra-vascular embolic protection system frame materials is Nitinol.

25. A foldable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a valve replacement detachably positioned about the scapus and capable of being folded so as to temporarily reduce the valve diameter by up to 50%; and

a foldable stent positioned about the exterior of the valve, the foldable stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts, the foldable stent being constructed of a memory shaped alloy.

26. The foldable, stented valve replacement scapus delivery system of claim 25 wherein the stent memory shaped alloy has an Af temperature between about 0°

C. and about 30°

C.

27. The foldable, stented valve replacement scapus delivery system of claim 25 wherein the stent is made of Nitinol.

28. The foldable, stented valve replacement scapus delivery system of claim 25 wherein the stent has three parallel support posts attached to the circular inflow and outflow rims at about 120°

intervals.

29. The foldable, stented valve replacement scapus delivery system of claim 25 wherein the scapus is a solid rod.

30. The foldable, stented valve replacement scapus delivery system of claim 25 wherein the scapus is a hollow rod.

31. The foldable, stented valve replacement scapus delivery system of either claim 29 or 30, wherein the scapus material is a stainless steel or a polymer plastistic.

32. A foldable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a valve replacement detachably positioned about the scapus and capable of being folded so as to temporarily reduce the valve diameter by up to 50%; and

a foldable stent positioned about the exterior of the heart valve, the foldable stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts, the foldable stent being constructed of a memory shaped alloy;

a first inflatable balloon delivery member positioned about the scapus at the distal end of the foldable, stented valve replacement, the first inflatable balloon delivery member, when inflated, having a larger diameter than the foldable, stented valve in order to prevent migration of the foldable stented valve; and

a second inflatable balloon delivery member positioned about the scapus at the proximal end of the foldable, stented valve replacement, the second inflatable balloon delivery member, when inflated, having a larger diameter than the foldable, stented valve replacement in order to further prevent migration of the foldable stented valve.

33. The foldable, stented valve scapus delivery system of claim 32 wherein the stent memory shaped alloy has an A_f temperature between about 0°

C. and about 30°

C.

34. The foldable, stented valve replacement scapus delivery system of claim 32 wherein the stent is made of Nitinol.

35. The foldable, stented valve replacement scapus delivery system of claim 32 wherein the stent has three parallel support posts attached to the circular inflow and outflow rims at about 120°

intervals.

36. The foldable, stented valve scapus delivery system of claim 32 wherein the foldable, stented valve is circumferentially surrounded by a balloon delivery member middle portion that is operatively connected to the first and second inflatable balloon delivery members for simultaneous inflation.

37. The foldable, stented valve scapus delivery system of claim 36 wherein the first and second inflatable balloon delivery members have a larger coefficient of friction than the balloon delivery member middle portion.

38. The foldable, stented valve scapus delivery system of claim 32 wherein the delivery system further includes a perfusion tube positioned about the scapus, the perfusion tube being operatively connected to one or more holes in the distally mounted first inflatable balloon delivery member in order to allow blood flow through the perfusion tube.

39. The foldable, stented valve scapus delivery system of claim 38 wherein both the second inflatable balloon delivery member and the balloon delivery middle portion are also operatively connected to the perfusion tube in order to allow for blood flow.

40. The foldable, stented valve scapus delivery system of claim 36 wherein a balloon inflation, adapted to inflate the first and second inflatable balloon delivery members and the balloon delivery middle portion, is secured to the exterior of the scapus at a plurality of locations.

41. The foldable, stented valve scapus delivery system of claim 32 wherein the scapus is a hollow rod containing one or more lumens within the hollow rod cavity.

42. A foldable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a valve replacement detachably positioned about the scapus and capable of being folded so as to temporarily reduce the valve diameter by up to 50%; and

a foldable stent positioned about the exterior of the heart valve, the foldable stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal support posts, the foldable stent being constructed of a memory shaped alloy capable of changing from a malleable martensite phase to a memorized austentite phase at an A_f temperature between about 0°

C. and about 30°

C. such that the stent is capable of being folded in the martensite phase so as to temporarily reduce its diameter by up to 50%; and

a compressible distal embolic protection filter detachably positioned about the scapus, the distal embolic protection filter being formed of one or more truncated porous bags, having an open filter mouth located adjacent the distal end of foldable, stented valve so as to operate, when expanded, as a temporary valve and prevent flush back of blood, embolic material and other debris.

43. The foldable, stented valve replacement scapus delivery system of claim 42 wherein the distal embolic protection filter and temporary valve is internally supported, when expanded, by a frame material of shape memory alloy.

44. The foldable, stented valve replacement scapus delivery system of claim 43, wherein the distal embolic protection filter and temporary valve frame materials is Nitinol.

45. A foldable, stented valve replacement scapus delivery system comprising:

an elongated substantially rigid scapus;

a valve replacement detachably positioned about the scapus and capable of being folded so as to temporarily reduce its diameter by up to 50%; and

a foldable stent positioned about the exterior of the heart valve, the foldable stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal commissural support posts, the foldable stent being constructed of a memory shaped alloy capable of changing from a malleable martensite phase to a memorized austentite phase at an A_f temperature between about 0°

C. and about 30°

C. such that the stent is capable of being folded in the martensite phase so as to temporarily reduce its diameter by up to 50%, wherein the foldable stent inflow rims are adapted to align with the inflow rim of a previously implanted heart valve prosthesis.

46. The foldable, stented valve replacement scapus delivery system of claim 45 wherein the stent A_f temperature is between about 15°

C. and about 25°

C.

47. The foldable, stented valve replacement scapus delivery system of claim 45 wherein the stent is made of Nitinol.

48. The foldable, stented valve replacement scapus delivery system of claim 45 wherein the stent has three parallel commissural support posts attached to the circular inflow and outflow rims at about 120°

intervals.

49. A foldable, stented valve replacement scapus delivery system comprising:

an elongated, substantially rigid scapus;

a valve replacement detachably positioned about the scapus and capable of being folded so as to temporarily reduce the valve diameter by up to 50%; and

a foldable stent positioned about the exterior of the heart valve, the foldable stent having a circular inflow rim and a circular outflow rim connected by a plurality of longitudinal commissural support posts, the foldable stent being constructed of a memory shaped alloy capable of changing from a malleable martensite phase to a memorized austentite phase at an A_f temperature between about 0°

C. and about 30°

C. such that the stent is capable of being folded in the martensite phase so as to temporarily reduce its diameter by up to 50%, wherein the foldable stent longitudinal commissural support posts are adapted to align with the commissural posts of a previously implanted heart valve prosthesis.

50. The foldable, stented valve replacement scapus delivery system of claim 49 wherein the stent A_f temperature is between about 15°

C. and about 25°

C.

51. The foldable, stented valve replacement scapus delivery system of claim 49 wherein the stent is made of Nitinol.

52. The foldable, stented valve replacement scapus delivery system of claim 49 wherein the stent has three parallel commissural support posts attached to the circular inflow and outflow rims at about 120°

intervals.