Heart Valve Implant And Methods For Delivering And Implanting Same

• US 20170325949A1
• Filed: 05/10/2017
• Published: 11/16/2017
• Est. Priority Date: 05/13/2016
• Status: Active Application

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Rodgers, Richard, Tallarida, Steve
• Application Number:
  US15/591,780
• Publication Number:
  US 20170325949A1
• Time in Patent Office: Days
• 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 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0086 Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

Heart valve implants and methods for implanting and delivering same are described. A heart valve implant can include a shaft, having a first end and a second end, an anchor, and a plurality of wafers. The anchor is coupled to the first end of the shaft and configured to secure the heart implant to a patient'"'"'s heart. The wafers are coupled to the second end of the shaft and configured to form a stacked array of wafers. The stacked array of wafers can partially reduce a flow of blood through a heart valve upon coming in contact with a portion of a leaflet of the heart valve.

Claims

1. A heart valve implant comprising:

a shaft having a first end and a second end;

an anchor coupled to the first end of the shaft, the anchor configured to secure the heart valve implant to a patient'"'"'s heart; and

a plurality of wafers, wherein each of the plurality of wafers is coupled to the second end of the shaft to form a stacked array of wafers.

2. The heart valve implant of claim 1, wherein the stacked array of wafers is configured to at least partially restrict a flow of blood through the heart valve during systole upon contact with at least a portion of a valve leaflet of the heart valve.

3. The heart valve implant of claim 2, wherein the stacked array of wafers comprises a compliant surface.

4. The heart valve implant of claim 1, further comprising an inflatable balloon, wherein said balloon surrounds at least a portion of the plurality of wafers.

5. The heart valve implant of claim 4, wherein the balloon is at least partially inflated with a fluid.

6. The heart valve implant of claim 1, wherein one or more of the plurality of wafers comprises a biocompatible polymer.

7. The heart valve implant of claim 6, wherein the biocompatible polymer comprises a polyurethane, a polyethylene terephthalate (PET) and polyethyleneoxide (PEO) block copolymer, a polystyrene and poly(1,4-butadiene) block copolymer, a triblock copolymer made from poly(2-methyl-2-oxazoline) and polytetrahydrofuran, a polysiloxane, a polyether, or a combination thereof.

8. The heart valve implant of claim 1, wherein one or more of the plurality of wafers comprises a shape memory material.

9. The heart valve implant of claim 8, wherein the shape memory material comprises nitinol.

10. The heart valve implant of claim 1, wherein the stacked array of wafers exhibits a tapered shape extending from a proximal end to a distal end.

11. The heart valve implant of claim 1, wherein the stacked array of wafers exhibits a diamond-like shape.

12. The heart valve implant of claim 1, wherein the plurality of wafers have variable cross-sectional diameters.

13. The heart valve implant of claim 12, wherein the cross-sectional shape of the stacked array of wafers includes at least one of round, pear-shaped, elliptical, hour-glass shaped, triangular, or heart shaped.

14. The heart valve implant of claim 1, wherein the plurality of wafers have substantially equal cross-sectional diameters.

15. The heart valve implant of claim 14, wherein the cross-sectional shape of the stacked array of wafers includes at least one of rectangle or square.

16. The heart valve implant of claim 1, wherein each of the plurality of wafers is slidably coupled to the shaft.

17. The heart implant of claim 1, wherein each of the plurality of the wafers is fixedly coupled to the shaft.

18. The heart valve implant of claim 1, further comprising a plurality of coupling members, wherein each of the plurality of coupling members is configured to couple at least one of the wafers to the shaft.

19. The heart valve implant of claim 1, further comprising one or more radiopaque markers.

20. The heart valve implant of claim 19, wherein the one or more radiopaque markers are disposed on the shaft, one or more of the plurality of wafers, or a combination thereof.

21. The heart valve implant of claim 1, wherein the anchor comprises at least one barb, a helical feature, at least one anchor pad, or a combination thereof.

22. The heart valve of claim 1, wherein said implant is a mitral valve implant.

23. A method of delivering a heart valve implant, the method comprising:

implanting the heart valve implant in a patient'"'"'s heart, the heart valve implant comprising;

a shaft having a first end and a second end;

an anchor coupled to said first end of said shaft, the anchor configured to secure the heart valve implant to heart tissue; and

a plurality of wafers, wherein each of the plurality of wafers is coupled to the second end of the shaft;

at least partially collapsing said plurality of wafers of said heart valve implant;

wherein implanting the heart valve implant comprises;

percutaneously inserting said heart valve implant into the heart;

securing said anchor of said heart valve implant to native coronary tissue of the heart; and

expanding the plurality of wafers to form a stacked array of wafers at least partially within a heart valve to at least partially restrict a flow of blood through a heart valve during systole upon contact with at least a portion of a valve leaflet of the heart valve.

24. The method of claim 23, wherein said step of percutaneously inserting the heart valve implant comprises using a catheter.

25. The method of claim 24, further including inserting the collapsed plurality of wafers into a lumen of the catheter and delivering said heart valve implant to a ventricle of the heart via said catheter.

26. The method of claim 23, further including securing the heart valve implant to any of an interior surface of the heart, an exterior surface of the heart, or a combination thereof.

27. The method of claim 23, wherein one or more of the plurality of wafers comprises a biocompatible polymer.

28. The method of claim 23, wherein one or more of the plurality of wafers comprises a shape memory material.

29. The method of claim 28, wherein the shape memory material comprises nitinol.

30. The method of claim 23, wherein the stacked array of wafers comprises a distal end and an proximal end.

31. The method of claim 23, wherein the heart valve implant further comprises an inflatable balloon that surrounds at least a portion of the plurality of wafers.

32. A method of delivering a heart valve implant, the method comprising:

percutaneously inserting a heart valve implant into a patient'"'"'s heart, wherein the heart valve implant comprises a shaft extending from a first end to a second end, an anchor coupled to the first end of the shaft, and a plurality of wafers coupled to the shaft in proximity of the second end of the shaft, and wherein said wafers are in an at least partially collapsed state;

securing said anchor of said heart valve implant to native coronary tissue; and

expanding the plurality of wafers to form a stacked array of wafers disposed at least partially within the heart valve so as to at least partially restrict a flow of blood through the heart valve during systole.