CONNECTION SYSTEMS FOR TWO PIECE PROSTHETIC HEART VALVE ASSEMBLIES AND METHODS FOR MAKING AND USING THEM

• US 20090319038A1
• Filed: 06/03/2009
• Published: 12/24/2009
• Est. Priority Date: 06/05/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Arbor Surgical Technologies, Inc. (Medtronic Plc)
• Inventors: Gurskis, Donnell W., Lane, Ernest, Ino, Takashi Harry, Bacich, Steven R.
• Granted Patent: US 8,323,337 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2250/006 modular

Abstract

A heart valve assembly includes a prosthesis and a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus. The prosthesis includes an annular member, a flexible core at least partially defining a sewing cuff extending radially outwardly from the annular member, a rail ring disposed between the flexible core and the annular member, and a plurality of guide rails extending from the rail ring through respective openings in the flexible core. A fabric covering covers the prosthesis, and the guide rails extend through respective openings in the fabric covering. The prosthetic valve includes a frame including receptacles for receiving respective guide rails. After implanting the prosthesis within a biological annulus, the prosthetic valve is advanced along the guide rails until retention elements on the guide rails engage the receptacles to secure the prosthetic valve relative to the prosthesis.

Claims

1. A prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus, comprising:

an annular member sized to be received within a biological annulus;

a rail ring disposed adjacent the annular member;

a plurality of guide rails extending from the rail ring transversely relative to a plane defined by the rail ring; and

a fabric covering substantially covering the annular member and rail ring, the guide rails extending from the rail ring through respective openings in the fabric covering.

2. The prosthesis of claim 1, wherein each of the guide rails comprises one or more retention elements for securing a prosthetic valve relative to the prosthesis.

3. The prosthesis of claim 1, further comprising a flexible core disposed adjacent the rail ring opposite the annular member, the flexible core substantially covered with the fabric covering to at least partially define a sewing cuff extending outwardly from the annular member.

4. The prosthesis of claim 3, wherein the annular member, rail ring, and flexible core are aligned concentrically with one another such that, when covered by the fabric covering, a fluid flow passage is defined through the prosthesis.

5. A method for making a prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus, the method comprising:

providing a rail ring including a plurality of elongate guide rails, the guide rails spaced apart about and extending from a periphery of the rail ring;

connecting the rail ring to an annular member at one or more locations about the periphery; and

substantially covering the rail ring and annular member with a fabric covering with the guide rails extending through respective openings in the fabric covering to define a fluid flow passage through the prosthesis.

6. The method of claim 5, further comprising attaching a skirt around the annular member, the skirt being biased to extend transversely from a lower edge of the annular member to cause the fabric covering to extend outwardly from the annular member.

7. The method of claim 6, wherein the skirt and annular member are formed as substantially flat bands, wherein the bands are rolled after attaching the skirt around the annular member, and wherein ends of the skirt are secured together to maintain the skirt and annular member in a substantially enclosed configuration at least partially defining the fluid flow passage.

8. The method of claim 5, wherein the rail ring and guide rails are integrally formed from a single sheet of material disposed within the plane, and wherein the guide rails are bent transversely relative to the plane after being formed from the single sheet.

9. The method of claim 5, further comprising positioning a flexible core adjacent the rail ring opposite the annular member, wherein substantially covering the rail ring and annular member with a fabric covering further comprises substantially covering the flexible core with the fabric covering to at least partially define a sewing cuff extending radially from the annular member.

10. The method of claim 9, further comprising:

directing the guide rails through respective holes in the flexible core; and

securing stress diffusers to the flexible core and rail ring adjacent the guide rails to substantially maintain the flexible core and rail ring relative to one another, while allowing the guide tails to move relative to one the flexible core.

11. The method of claim 9, further comprising attaching a collar to the sewing cuff opposite the annular member, the collar shaped for receiving a prosthetic heart valve therein to enhance a seal between the sewing cuff and the prosthetic heart valve.

12. A prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus, comprising:

an annular member sized to be received within a biological annulus;

a sewing cuff extending outwardly from the annular member above a plane of the annular member;

an annular skirt extending outwardly from the annular member below the annular member;

a rail ring disposed between the sewing cuff and the annular member generally within a plane; and

a plurality of guide rails extending from the rail ring transversely relative to the plane.

13-18. -18. (canceled)

21. A heart valve assembly implantable within a biological annulus, comprising:

a first prosthesis comprising an annular member implantable within a biological annulus, a sewing cuff comprising a flexible core extending radially outwardly from the annular member, a rail ring disposed between the annular member and the flexible core, and a plurality of guide rails extending from the rail ring;

a second valve prosthesis comprising an annular frame and receptacles for receiving respective guide rails such that the second prosthesis may be directed along the guide rails towards the first prosthesis; and

retention elements on the guide rails for engaging the receptacles to secure the second prosthesis relative to the first prosthesis.

22. The heart valve assembly of claim 21, wherein the retention elements comprise a substantially blunt lower surface and a tapered upper surface.

23. The heart valve assembly of claim 22, wherein the receptacles comprises detents on spring elements for engaging the retention elements to secure the second prosthesis relative to the first prosthesis.

26. The heart valve assembly of claim 21, wherein the plurality of guide rails extend upwardly from the rail ring.

24-25. -25. (canceled)

27. The heart valve assembly of claim 21, wherein each of the guide rails includes a weakened region above the retention elements for detaching an upper portion of the guide rail from a lower portion.

27-34. -34. (canceled)

35. A method for implanting a heart valve assembly in a biological annulus, the method comprising:

inserting a first annular prosthesis into the biological annulus, the first prosthesis comprising a plurality of guide rails extending from a rail ring;

securing the first prosthesis to tissue surrounding the biological annulus;

directing free ends of the guide rails through respective receptacles on a second valve prosthesis; and

advancing the second prosthesis along the guide rails towards the first prosthesis until the receptacles substantially engage retention elements on the guide rails, thereby substantially securing the second prosthesis relative to the first prosthesis.