Percutaneous transcatheter heart valve replacement

• US 20040210307A1
• Filed: 04/18/2003
• Published: 10/21/2004
• Est. Priority Date: 04/18/2003
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Alexander Khairkhahan
• Inventors: Khairkhahan, Alexander
• Granted Patent: US 7,175,656 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

The present invention provides improved devices and methods for replacing or repairing a malfunctioning heart valve. In particular, improved minimally invasive methods and devices are provided for percutaneous transcatheter implantation of expansible prosthetic heart valves within or adjacent a valved anatomic site within the heart. In one embodiment, an expansible prosthetic heart valve comprises an implantable structure, a flexible membrane, and a membrane support. The implantable structure is expansible from a first reduced diameter to a second enlarged diameter and has a flow path therethrough. The flexible membrane is positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction. The membrane support is positionable in the flow path and affixed to the implantable structure.

Claims

1. An expansible prosthetic heart valve comprising:

an implantable structure which is expansible from a first reduced diameter to a second enlarged diameter and having a flow path therethrough;

a flexible membrane positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; and

a membrane support positionable in the flow path and affixed to the implantable structure.

2. An expansible valve as in claim 1, wherein the membrane support comprises at least one radial rib extending across the flow path.

3. An expansible valve as in claim 1, wherein the membrane support comprises a circular wire frame.

4. An expansible valve as in claim 1, wherein the membrane support and the implantable structure define an integral framework.

5. An expansible valve as in claim 1, wherein the flexible membrane is attached to a central portion of the membrane support.

6. An expansible valve as in claim 1, wherein the flexible membrane has a substantially circular shape.

7. An expansible valve as in claim 1, wherein the flexible membrane has a substantially conical shape.

8. An expansible valve as in claim 1, wherein the flexible membrane comprises at least one leaflet.

9. An expansible valve as in claim 1, wherein the flexible membrane comprises a displaceable, expandable valve member.

10. An expansible valve as in claim 1, wherein the flexible membrane comprises expanded polytetrafluoroethylene or biological materials.

11. An expansible valve as in claim 1, wherein the implantable structure and membrane support are fixed during opening and closing of the flow path by the flexible membrane.

12. An expansible valve as in claim 1, wherein the implantable structure comprises a tubular framework.

13. An expansible valve as in claim 12, wherein the framework comprises a plurality of struts, wherein at least three struts are longer than the remaining struts.

14. An expansible valve as in claim 12, wherein the framework further comprises a plurality of radial protrusions extending beyond the framework when the framework is implanted within or adjacent an intraluminal site.

15. An expansible valve as in claim 14, wherein the radial protrusions extend circumferentially and longitudinally from an outer surface of the framework.

16. An expansible valve as in claim 1, wherein the implantable structure is covered with a layer of expanded polytetrafluoroethylene or biological materials.

17. An expansible valve as in claim 1, wherein at least a portion of the implantable structure, flexible membrane, or membrane support is coated with an anti-thrombogenic substance.

18. An expansible valve as in claim 1, wherein the implantable structure, flexible membrane, and membrane support are expandable from a first reduced profile configuration to a second enlarged profile configuration.

19. An expansible prosthetic heart valve comprising:

an implantable structure which is expansible from a first reduced diameter to a second enlarged diameter and having a flow path therethrough;

a displaceable, expandable valve member positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; and

a valve member support positionable in the flow path.

20. An expansible valve as in claim 19, wherein the displaceable valve member is affixed to the valve member support.

21. An expansible valve as in claim 20, wherein the displaceable valve member and valve member support comprises an expandable ball valve.

22. An expansible valve as in claim 21, wherein the ball valve is coupled to the implantable structure at a hinge point, and wherein the ball valve is centrally supported.

23. An expansible valve as in claim 21, wherein the ball valve is axially slidable relative to the implantable structure.

24. An expansible valve as in claim 20, wherein the displaceable valve member and valve member support are displaced during opening and closing of the flow path.

25. An expansible prosthetic heart valve comprising:

a tubular framework which is expansible from a first reduced diameter to a second enlarged diameter and having a flow path along a tubular axis, wherein the framework comprises a plurality of struts, wherein at least three of the struts are longer than the remaining struts;

a flexible membrane positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; and

a membrane support affixed to the tubular framework and disposed in the flow path when the framework has the enlarged diameter, wherein the membrane support inhibits movement of the flexible membrane in the second direction when the prosthetic heart valve is closed and does not substantially flex during opening and closing of the flow path with the flexible membrane.

26. A method for implanting an expansible prosthetic heart valve, the method comprising:

providing a prosthetic heart valve having an expansible structure, a flexible membrane, and a membrane support;

implanting the expansible structure within or adjacent to an intraluminal site and expanding the structure from a first reduced diameter to a second enlarged diameter, wherein a flow path extends therethrough;

positioning the flexible membrane in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; and

positioning the membrane support in the flow path, wherein the membrane support does not flex during opening and closing of the flow path by the flexible membrane.

27. A method as in claim 26, wherein the intraluminal site comprises a mitral valve, aortic valve, pulmonary valve, or tricuspid valve annulus of the heart.

28. A method as in claim 26, wherein the membrane support is affixed to the structure, and wherein the membrane support and structure are fixed during opening and closing of the flow path by the flexible membrane.

29. A method as in claim 26, wherein the flexible membrane comprises an expandable valve member affixed to the membrane support, further comprising displacing the expandable valve member and membrane support at a hinge or in an axial direction relative to the structure.

30. A method as in claim 26, wherein implanting is carried out by percutaneously passing a catheter endoluminally through an anatomic passageway to a valved anatomic site within the heart.

31. A method as in claim 26, wherein implanting further comprises aligning the structure within the intraluminal site with at least three long struts.

32. A method as in claim 26, further comprising anchoring the structure with a plurality of hooks.

33. A method as in claim 26, wherein positioning further comprises expanding the membrane support from a first reduced profile configuration to a second enlarged profile configuration.

34. A method as in claim 26, wherein positioning further comprises expanding the flexible membrane from a first reduced profile configuration to a second enlarged profile configuration.