Percutaneously deliverable heart valve

• US 20040049266A1
• Filed: 09/11/2002
• Published: 03/11/2004
• Est. Priority Date: 09/11/2002
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Tu, Hosheng, Quijano, Rodolfo C., Anduiza, James Peter
• Granted Patent: US 6,875,231 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

This invention discloses a percutaneously deliverable heart valve and delivery means thereof, wherein the percutaneously deliverable heart valve is a foldable heart valve prosthesis to replace a diseased valve of a patient comprising: a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of each crossbar; a flexible tissue heart valve with a plurality of valvular leaflets attached to the support structure; and a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to coupling the first and the second crossbars.

Claims

1. A foldable heart valve prosthesis to replace a diseased valve of a patient comprising:

a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of each crossbar;

a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and

a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to coupling the first and the second crossbars.

2. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is a porcine valve.

3. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is made of pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.

4. The foldable heart valve prosthesis of claim 2 or claim 3, wherein the flexible tissue heart valve is chemically treated to reduce antigenicity of said tissue material.

5. The foldable heart valve prosthesis of claim 4, wherein the flexible tissue heart valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds.

6. The foldable heart valve prosthesis of claim 1, wherein at least one slidable ring connector is slid to adjacent an end of the first crossbar when said heart valve prosthesis is folded.

7. The foldable heart valve prosthesis of claim 1, wherein the first crossbar of the first crossbar frame has a recess configured for coupling the second crossbar of the second crossbar frame.

8. The foldable heart valve prosthesis of claim 7, wherein the second crossbar comprises a recess, the recess of the first crossbar facing the recess of the second crossbar.

9. The foldable heart valve prosthesis of claim 7, wherein the recess of the first crossbar is located close to an end of the first crossbar.

10. The foldable heart valve prosthesis of claim 1, wherein the slidable ring connector is made of an elastic material.

11. The foldable heart valve prosthesis of claim 1, wherein the slidable ring connector is made of a coil spring material.

12. The foldable heart valve prosthesis of claim 1, wherein the slidable ring connector is made of a shape-memory material configured to shrinkably coupling the first crossbar and the second crossbar snugly.

13. The foldable heart valve prosthesis of claim 11, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.

14. The foldable heart valve prosthesis of claim 13, wherein a shape-transition temperature of the shape-memory material is between about 40°

C. to about 50°

C.

15. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is an aortic valve.

16. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is a pulmonary valve.

17. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is an atrioventricular valve.

18. The foldable heart valve prosthesis of claim 1, wherein the flexible tissue heart valve is generally mounted on the support structure at commissural points of said flexible tissue heart valve and is secured to the crossbar frames.

19. The foldable heart valve prosthesis of claim 1, wherein the support structure is made of a material selected from a group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, polyester, shape-memory material, and mixture thereof.

20. The foldable heart valve prosthesis of claim 1, wherein the slidable ring connector is configured and sized to show minimal circumference after being coupled to the crossbars.

21. The foldable heart valve prosthesis of claim 20, wherein an angle of the coupled crossbars after being coupled with said slidable ring connector is at least 15 degrees.

22. The foldable heart valve prosthesis of claim 1, wherein the support structure is self-expandable.

23. A method for minimally invasively delivering a foldable heart valve prosthesis into a patient, the foldable heart valve prosthesis comprising a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars;

a flexible tissue heart valve with a plurality of valvular leaflets attached to said support structure; and

a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to coupling the first and the second crossbars;

said method comprising;

folding said support structure with the attached flexible tissue heart valve inside a lumen of a delivery apparatus;

delivering said delivery apparatus to a target valvular annulus of the patient;

unfolding said support structure to deploy said foldable heart valve prosthesis in place; and

coupling the crossbars by sliding the slidable ring connector to an appropriate location of the crossbars.

24. The method of claim 23, wherein the delivery apparatus comprises a catheter.

25. The method of claim 24, wherein the delivery step is carried out with said catheter through an opening selected from a group consisting of a carotid artery, a jugular vein, a subclavian vein, and a body vessel.

26. The method of claim 24, wherein the catheter is made of a material selected from a group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, and polyester.

27. The method of claim 23, wherein the unfolding step is carried out by the support structure that is self-expandable.

28. The method of claim 23, wherein the delivery apparatus comprises a cannula.

29. The method of claim 28, wherein the delivery step is carried out with said cannula through a percutaneous intercostal penetration.

30. The method of claim 29 further comprising a step of removing at least a portion of a patient'"'"'s heart valve by means of a cutting tool introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall before the unfolding step.

31. The method of claim 29, wherein the step of removing is carried out by providing radiofrequency energy to the cutting tool.

32. The method of claim 29 further comprising a step of fastening the unfolded heart valve within the valvular annulus by means of an instrument introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall after the unfolding step.

33. The method of claim 23, wherein the folding step is carried out after a step of sliding at least one of the slidable ring connectors to adjacent an end of the first crossbar.

34. The method of claim 23 further comprising a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the slidable ring connector.

35. The method of claim 34, wherein the shrinking step is carried out by raising a temperature of the ring connector above a shape-transition temperature of a shape-memory material, said slidable ring connector being made of said shape-memory material.

36. The method of claim 35, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.

37. The method of claim 35, wherein the shape-transition temperature of the shape-memory material is between about 40°

C. to about 50°

C.

38. The method of claim 23, wherein the flexible tissue heart valve is an aortic valve.

39. The method of claim 23, wherein the flexible tissue heart valve is a pulmonary valve.

40. The method of claim 23, wherein the flexible tissue heart valve is an atrioventricular valve.

41. The method of claim 23, wherein the tissue heart valve is a porcine valve.

42. The method of claim 23, wherein the flexible tissue heart valve is made of pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.

43. The method of claim 41 or 42, wherein the flexible tissue heart valve is chemically treated to reduce antigenicity of said tissue material.

44. The method of claim 43, wherein the flexible tissue heart valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds.

45. The method of claim 23, wherein the unfolding step is carried out by an inflatable balloon on a catheter.

46. The method of claim 45, wherein the balloon is selected from a group consisting of compliant material, non-compliant material, and semi compliant material.

47. A method for minimally invasively delivering a foldable heart valve into a patient, the foldable heart valve comprising a support structure having a plurality of crossbars and a plurality of slidable ring connectors;

said method comprising;

folding said valve within a lumen of delivery means for delivering said valve to a target valvular annulus of the patient;

unfolding said valve in place by a balloon catheter, wherein a differentially expandable balloon of the balloon catheter is configured to expand the folded heart valve into an oval unfolded valve; and

coupling the crossbars by sliding the slidable ring connector to an appropriate location of the crossbars.

48. The method of claim 47, wherein said differentially expandable balloon comprises a longitudinal axis, a major traverse axis and a minor traverse axis, the major traverse axis being at least 10% longer than the minor traverse axis.

49. The method of claim 47, wherein said differentially expandable balloon is delivered through a percutaneous intercostal penetration of the patient.

50. The method of claim 49, wherein said differentially expandable balloon is delivered through an opening selected from a group consisting of a carotid artery, a jugular vein, a subclavian vein, and a body vessel.

51. The method of claim 47 further comprising a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the slidable ring connector.

52. The method of claim 51, wherein the shrinking step is carried out by raising a temperature of the ring connector above a shape-transition temperature of a shape-memory material, said slidable ring connector being made of said shape-memory material.

53. The method of claim 52, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.

54. The method of claim 52, wherein the shape-transition temperature of the shape-memory material is between about 40°

C. to about 50°

C.