Apparatus and methods for repairing the function of a diseased valve and method for making same

• US 7,799,072 B2
• Filed: 05/18/2006
• Issued: 09/21/2010
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Greenberg, Roy K.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): STROUD, JONATHAN R
• Application Number:
  US11/436,521
• Publication Number:
  US 20060276813A1
• Time in Patent Office: 1,587 Days
• Field of Search: 623/1.13, 623/1.26, 623/2.1
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2220/0066 stapled
• CPC Class Codes: A61F 2230/0017 Angular shapes

Abstract

An apparatus for repairing the function of a diseased valve includes an annular first support member expandable to a first diameter. An annular second support member is spaced axially apart from the first support member and is expandable to a second diameter that is independent of the first diameter. A tubular graft section interconnects the first and second support members. The graft section defines an annulus having a third diameter that is independent of each of the first and second diameters. A prosthetic valve is secured within the annulus of the graft section. The bioprosthetic valve has at least two valve leaflets that are coaptable to permit the unidirectional flow of blood. Methods for repairing the function of a diseased valve and for making the apparatus are also provided.

Claims

1. An apparatus for repairing the function of a diseased valve, the apparatus comprising:

a tubular first support member expandable to a first diameter and having oppositely disposed proximal and distal first support member ends;

a tubular second support member spaced axially apart from the first support member and expandable to a second diameter that is independent of the first diameter, the second support member having oppositely disposed proximal and distal second support member ends;

a tubular graft section interconnecting the first and second support members and defining an annulus having a third diameter that is independent of each of the first and second diameters, the graft section having oppositely disposed proximal and distal graft section ends, the proximal graft section end being connected directly to the distal first support member end and the distal graft section end being connected directly to the proximal second support member end; and

a prosthetic valve secured within the annulus of the graft section, the prosthetic valve having at least two valve leaflets that are coaptable to permit the unidirectional flow of blood;

wherein

the first and second support members are interconnected only by the graft section, and the prosthetic valve is directly secured only to the graft section; and

wherein

the graft section has an hourglass shape with a neck portion, the neck portion of the graft section defining the annulus of the valve, and a converging portion and a diverging portion on opposite sides of the neck portion; and

at least one conduit puncturing longitudinally through the converging and diverging neck portions and connecting to form a smaller secondary lumen therethrough.

2. The apparatus of claim 1, further comprising an expandable ring encircling the annulus of the graft section and supporting the prosthetic valve secured within the annulus.

3. The apparatus of claim 1, wherein the graft section overlaps and is secured to an outer surface of at least one of the first and second support members.

4. The apparatus of claim 1, wherein the graft section overlaps and is secured to an outer surface of one of the first and second support members and the graft section overlaps and is secured to an inner surface of the other of the first and second support members.

5. The apparatus of claim 1, further comprising at least one tubular conduit having first and second ends, the second end being received in the at least one passage in the graft section, the first end for positioning in a branch blood vessel.

6. The apparatus of claim 1, further comprising at least two graft extensions having first and second ends, the first end of each graft extension being secured to the graft section and the second end of each graft extension providing support to a valve leaflet.

7. The apparatus of claim 6, wherein each graft extension is formed integrally with the graft section.

8. The apparatus of claim 6, further comprising an extension support ring, with the second end of each graft extension being attached to the extension support ring.

9. The apparatus of claim 1, wherein the prosthetic valve has a center valve axis, the graft section has a center graft axis, and the prosthetic valve is secured within the annulus of the graft section with the center valve axis being axially offset from the center graft axis.

10. The apparatus of claim 1, wherein the first and second support members are each substantially made from a first material and the graft section is substantially made from a second material.