Apparatus for treating a heart valve

• US 9,763,782 B2
• Filed: 07/19/2016
• Issued: 09/19/2017
• Est. Priority Date: 04/21/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US15/214,362
• Publication Number:
  US 20160324641A1
• Time in Patent Office: 427 Days
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

An apparatus for treating a heart valve in need thereof comprises a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

Claims

1. An apparatus for treating a native heart valve in need thereof, the apparatus comprising:

a valve member, the valve member movable between an open state and a closed state, the valve member in the open state extending primarily in a direction along blood flow, the valve member in the closed state extending in a direction transverse to blood flow, the valve member including a plurality of flaps arranged side-by-side with adjacent surfaces having coaptation areas in close contact with each other to prevent leakage between the flaps, the flaps comprising glutaraldehyde-treated pericardial tissue;

a stent arranged for placement at a native heart valve with the valve member disposed within the stent, the stent at least partially covered;

an anchoring member arranged to fix the position of the valve member at the native heart valve, the anchoring member disposed on an outflow side of the valve member; and

an elongate connecting member extending between the valve member and the anchoring member, the connecting member axially spacing the valve member from the anchoring member, wherein at least a portion of the connecting member is flexible,

wherein the valve member is compressible for insertion using a catheter.

2. The apparatus of claim 1, wherein the anchoring member comprises a disk-shaped element, the disk-shaped element engageable with a portion of connecting member extendable through a heart wall, the disk-shaped element suitable for contacting the heart wall and preventing the anchoring member from migrating through the heart wall.

3. The apparatus of claim 1, wherein the disk-shaped element is a first disk-shaped element, the anchoring member further comprising a second disk-shaped element engageable with a portion of the connecting member.

4. The apparatus of claim 1, wherein the anchoring member is suitable for engaging with, or partially or wholly penetrating tissue.

5. The apparatus of claim 1, wherein the anchoring member comprises hooks, barbs, or spikes.

6. The apparatus of claim 1, wherein the apparatus is dimensioned for positioning the valve member at a native mitral valve and the anchoring member at a ventricular wall.

7. A kit comprising the apparatus of claim 1 and a delivery catheter.

8. An apparatus for treating a heart valve in need thereof, the apparatus comprising:

a valve member, the valve member movable between an open state and a closed state, the valve member in the open state extending primarily in a direction along blood flow, the valve member in the closed state extending in a direction transverse to blood flow, the valve member including a plurality of flaps arranged side-by-side with adjacent surfaces having coaptation areas in close contact with each other to prevent leakage between the flaps;

an anchoring member arranged to fix the position of the valve member at a native heart valve, the anchoring member disposed on an outflow side of the valve member; and

an elongate connecting member extending between the valve member and the anchoring member, the connecting member axially spacing the valve member from the anchoring member.

9. The apparatus of claim 8, wherein the plurality of flaps is made from biological tissue, heart valve, blood vessel, or pericardial tissue.

10. The apparatus of claim 8, wherein the plurality of flaps is made from animal tissue treated with glutaraldehyde.

11. The apparatus of claim 8, wherein the anchoring member comprises a disk-shaped element, the disk-shaped element engageable with a portion of connecting member extendable through a heart wall, the disk-shaped element suitable for contacting the heart wall and preventing the anchoring member from migrating through the heart wall.

12. The apparatus of claim 11, wherein the disk-shaped element is a first disk-shaped element, the anchoring member further comprising a second disk-shaped element engage able with a portion of the connecting member.

13. The apparatus of claim 8, wherein the anchoring member is suitable for engaging with, or partially or wholly penetrating tissue.

14. The apparatus of claim 8, wherein the anchoring member comprises hooks, barbs, or spikes.

15. The apparatus of claim 8, wherein the anchoring member comprises a shape memory material, nitinol, stainless steel, or spring steel.

16. The apparatus of claim 8, wherein at least a portion of the connecting member is flexible.

17. The apparatus of claim 8, further comprising a stent arranged for placement at the native heart valve with the valve member disposed within the stent.

18. The apparatus of claim 17, wherein the stent is an at least partially covered stent.

19. The apparatus of claim 8, wherein the apparatus is dimensioned for positioning the valve member at a native mitral valve and the anchoring member at a ventricular wall.

20. A kit comprising the apparatus of claim 8, wherein a diameter of the valve member is compressible, and a delivery catheter.