Prosthetic Valve with Sealing Members and Methods of Use Thereof

• US 20110264206A1
• Filed: 04/21/2011
• Published: 10/27/2011
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tabor, Charles
• Granted Patent: US 9,545,306 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2250/0069 Sealing means

Abstract

Embodiments of the present invention provide prosthetic valves having sealing members on the external surface thereof. The prosthetic heart valves of the present invention are preferably delivered by catheter directly through the apex of the heart or by other close range transcatheter delivery methods. Because these methods of implantation require a shorter length of catheter, a prosthetic valve can be more accurately oriented in the desired implantation location. Fluoroscopy can be used to further assist in orientation of the valve. The sealing members of the present invention can be positioned on the prosthetic valve such that, when the prosthetic valve is implanted in a native annulus, each provided sealing member is located adjacent to a commissural point of the native valve leaflets. Because the sealing members are precisely oriented on the prosthetic valve, a physician can ensure that the sealing members are aligned with the commissural points of the native valve leaflets. In embodiments of the present invention, the prosthetic valve can have a waisted middle section, and the sealing members can be located in the waisted middle section such that the crimped diameter of the prosthetic valve is not negatively impacted by the sealing members.

Claims

1. A prosthetic heart valve assembly comprising:

a prosthetic valve including a circumferential wall having an inner surface and an outer surface, wherein the prosthetic valve is radially contractible and expandable for transcatheter delivery to a native annulus; and

two or more sealing members mounted on the prosthetic valve and substantially evenly placed around the prosthetic valve, wherein the sealing members are configured to engage gaps existing between the implanted prosthesis and the native valve to prevent paravalvular leakage.

2. The prosthetic heart valve assembly of claim 1, wherein the prosthetic valve comprises an inflow section, an outflow section, and a waisted middle section having an expanded diameter less than the expanded diameters of the inflow section and the outflow section, and wherein the sealing members are positioned in the waisted middle section of the prosthetic valve.

3. The prosthetic heart valve assembly of claim 1, wherein the sealing members include at least three sealing members configured to engage the three commissure points of leaflets of a native tricuspid valve to prevent paravalvular leakage.

4. The prosthetic heart valve assembly of claim 3, wherein the sealing members include three additional sealing members positioned approximately midway between the commissural points of a native tricuspid valve.

5. The prosthetic heart valve assembly of claim 1, wherein the sealing members comprise at least one pad.

6. The prosthetic heart valve assembly of claim 5, wherein at least one of the sealing members includes two pads.

7. The prosthetic heart valve assembly of claim 5, wherein the prosthetic valve comprises support arms extending from the outer surface of the circumferential wall, and the support arms are configured to contact tissue adjacent to an outflow end of a native annulus to brace the prosthetic valve in position.

8. The prosthetic heart valve assembly of claim 1, wherein the sealing members comprise polyethylene terephthalate.

9. The prosthetic heart valve assembly of claim 1, wherein the sealing members comprise biological tissue.

10. A prosthetic heart valve assembly comprising:

a prosthetic valve including a circumferential wall having an inner surface and an outer surface, wherein the prosthetic valve comprises an inflow section, an outflow section, and a waisted middle section having an expanded diameter less than the expanded diameters of the inflow section and the outflow section;

at least one commissural seal pad mounted on the prosthetic valve at a location corresponding to the commissural points of the leaflets of a native valve, wherein the commissural seal pads are configured to prevent paravalvular leak,

wherein the at least one commissural seal pad is positioned in the waisted middle section of the prosthetic valve.

11. The prosthetic heart valve assembly of claim 10, wherein the commissural seal pads comprise polyethylene terephthalate.

12. The prosthetic heart valve assembly of claim 10, wherein the commissural seal pads comprise biological tissue.

13. The prosthetic heart valve assembly of claim 10, wherein the prosthetic valve comprises commissural posts for supporting tissue leaflets, and wherein the at least one commissural seal pad is mounted to the frame at a location that is longitudinally aligned with a commissural post.

14. The prosthetic heart valve assembly of claim 10 comprising a circumferential commissural seal pad extending around the circumference of the waisted middle section of the prosthetic valve.

15. The prosthetic heart valve assembly of claim 13 comprising three commissural seal pads mounted on the prosthetic valve.

16. The prosthetic heart valve assembly of claim 13, wherein the size of the circumferential commissural seal pad varies along the length of the circumferential commissural seal pad, and wherein the size of the circumferential commissural seal pad is the largest at portions of the circumferential commissural seal pad that are longitudinally aligned with the commissural posts.

17. A method of using a prosthetic valve, the method comprising:

obtaining a prosthetic valve comprising;

a prosthetic valve including a circumferential wall having an inner surface and an outer surface, wherein the prosthetic valve is radially contractible and expandable for transcatheter delivery to a native annulus; and

two or more sealing members mounted on the prosthetic valve and substantially evenly placed around the prosthetic valve, wherein the sealing members are configured to engage gaps existing between the implanted prosthesis and the native valve to prevent paravalvular leakage; and

radially contracting the prosthetic valve so that the one or more sealing members do not extend beyond the maximum diameter of the outer surface of the prosthetic valve.

18. The method of claim 17, further comprising loading the radially compressed prosthetic valve into a catheter assembly.

19. The method of claim 18, further comprising advancing the catheter assembly into a native heart valve annulus.

20. The method of claim 19, further comprising withdrawing the catheter assembly after delivering the prosthetic valve.