PERCUTANEOUS HEART VALVE PROSTHESIS

• US 20170296339A1
• Filed: 07/06/2017
• Published: 10/19/2017
• Est. Priority Date: 03/11/2004
• Status: Active Grant

• Current Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Original Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Inventors: Thambar, Suku, Jayasinghe, Stayajit Rohan
• Granted Patent: US 10,085,835 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6).

Claims

1. A percutaneous mitral valve prosthesis comprising:

a valve body having a first end, a second end, a longitudinal axis, and a blood flow passage extending along the longitudinal axis between the first end and the second end, the valve body collapsible about the longitudinal axis to fit within a catheter for delivery, the valve body tapered in an uncollapsed state with the first end sized to pass through a mitral valve orifice and the second end sized to not pass through the mitral valve orifice, the valve body including a valve body frame comprising nitinol;

a flexible skirt comprising polyester, the flexible skirt extending around a periphery of the valve body, the flexible skirt dimensioned for blocking blood flow between the valve body and native mitral valve tissue,

a one-way valve secured to the valve body frame, the one-way valve including a plurality of flexible valve leaflets around the blood flow passage, the flexible valve leaflets comprising pericardial material;

an anchor device having a plate-like configuration suitable for anchoring the valve body against migration;

three lines, a first end of each of the three lines secured to the first end of the valve body, and the second ends of the three lines converging; and

an anchor line comprising secured to and extending between the second ends of the three lines and the anchor device, the anchor line comprising a flexible wire or cord.

2. The percutaneous mitral valve prosthesis of claim 1, wherein the flexible skirt is sutured to the valve body frame.

3. The percutaneous mitral valve prosthesis of claim 1, wherein the valve leaflets are sutured to the valve body frame.

4. The percutaneous mitral valve prosthesis of claim 1, wherein the anchor device is collapsible to fit within a catheter for delivery, and includes a plurality of elongate anchor frame elements.

5. The percutaneous mitral valve prosthesis of claim 4, wherein tension on the anchor line urges the anchor device in the plate-like configuration.

6. The percutaneous mitral valve prosthesis of claim 1, wherein the anchor line comprises nitinol wire, stainless steel wire, carbon fibre, polyimide, aromatic polyamide, polyether block amide, silicone, or polyurethane.

7. A system for replacing a mitral valve comprising the percutaneous mitral valve of claim 1 and a delivery catheter into which the percutaneous mitral valve is loadable in a radially collapsed state.

8. A percutaneous mitral valve prosthesis comprising:

a valve body having a valve body first end, a valve body second end and a passage extending along a longitudinal axis between said valve body first end and said valve body second end, the valve body collapsible about the longitudinal axis for delivery via catheter;

one or more flexible valve elements secured to the valve body, the one or more flexible valve elements extending across the passage for blocking bloodflow in one direction through the passage;

an anchor device; and

an anchor line secured to and extending between the valve body and the anchor device.

9. The percutaneous mitral valve prosthesis of claim 8, wherein the valve body comprises nitinol.

10. The percutaneous mitral valve prosthesis of claim 8, wherein the valve body includes a plurality of elongate valve body frame elements.

11. The percutaneous mitral valve prosthesis of claim 8, wherein the valve body tapers from the first end to the second end, the second end of sized to not pass through a mitral valve orifice in an uncollapsed state.

12. The percutaneous mitral valve prosthesis of claim 8, further comprising a flexible skirt extending around a periphery of the valve body.

13. The percutaneous mitral valve prosthesis of claim 12, wherein the flexible skirt comprises pericardial material, silicone, polyester, or dacron.

14. The percutaneous mitral valve prosthesis of claim 12, wherein the flexible skirt is sutured to the valve body frame.

15. The percutaneous mitral valve prosthesis of claim 8, wherein the one or more flexible valve elements include pericardial material.

16. The percutaneous mitral valve prosthesis of claim 8, wherein the one or more flexible valve elements include three valve leaflets.

17. The percutaneous mitral valve prosthesis of claim 8, wherein the anchor device included a collapsible anchor frame

18. The percutaneous mitral valve prosthesis of claim 17, wherein the collapsible anchor frame has a flat plate-like configuration and an elongate configuration.

19. The percutaneous mitral valve prosthesis of claim 8, further comprising three further lines, a first end of each further line secured to the valve body first end, a second end of each further line converging to and secured to the anchor line.

20. The percutaneous mitral valve prosthesis of claim 8, wherein the anchor line comprises nitinol wire, stainless steel wire, carbon fibre, polyimide, aromatic polyamide, polyether block amide, silicone, or polyurethane.

21. A system for replacing a mitral valve comprising the percutaneous mitral valve of claim 8 and a delivery catheter into which the percutaneous mitral valve is loadable in a radially collapsed state.