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

• US 20060276813A1
• Filed: 05/18/2006
• Published: 12/07/2006
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Greenberg, Roy K.
• Granted Patent: US 7,799,072 B2
• Time in Patent Office: Days
• US Class Current: 606/158
• 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:

an annular first support member expandable to a first diameter;

an annular second support member spaced axially apart from the first support member and expandable to a second diameter that is independent of the first diameter;

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; and

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

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 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 is secured to an outer surface of one of the first and second support members and is secured to an inner surface of the other of the first and second support members.

5. The apparatus of claim 1, wherein the graft section has an hourglass shape with a neck portion, the neck portion of the graft section defining the annulus.

6. The apparatus of claim 5, wherein the graft section includes a converging portion and a diverging portion on opposite sides of the neck portion.

7. The apparatus of claim 6, wherein the graft section includes at least one passage extending axially through the converging and diverging portions.

8. The apparatus of claim 7, 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.

9. 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.

10. The apparatus of claim 9, wherein each graft extension is formed integrally with the graft section.

11. The apparatus of claim 9, further comprising an extension support ring, with the second end of each graft extension being attached to the extension support ring.

12. 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.

13. A method for making an apparatus to repair the function of a diseased valve, the method comprising the steps of:

providing an annular first support member expandable to a first diameter;

providing an annular second support member expandable to a second diameter that is independent of the first diameter;

providing a tubular graft section defining an annulus having a third diameter that is independent of each of the first and second diameters;

interconnecting the first and second support members with the graft section such that the support members are spaced axially apart by the graft section;

providing a bioprosthetic valve having at least two valve leaflets that are coaptable to permit the unidirectional flow of blood; and

securing the prosthetic valve within the annulus of the graft section.

14. The method of claim 13, wherein the step of interconnecting the first and second support members with the graft section comprises the steps of:

securing one end of the graft section to an outer surface of one of the support members; and

securing the other end of the graft section to an inner surface of the other support member.

15. The method of claim 13, further comprising the step of providing an expandable ring that encircles the annulus of the graft section, wherein the step of securing the prosthetic valve includes securing the prosthetic valve to the expandable ring.

16. The method of claim 13, further comprising the steps of:

providing a tubular conduit having oppositely disposed first and second ends; and

inserting the tubular conduit into an axial passage through the graft section such that the second end of the conduit remains in the passage and the first end extends therefrom.

17. The method of claim 13, wherein the graft section has an hourglass shape with a neck portion, the neck portion of the graft section defining the annulus.

18. The method of claim 13, wherein the step of securing the prosthetic valve within the annulus of the graft section includes the steps of:

providing at least two graft extensions having first and second ends;

securing the first ends of the graft extensions to the graft section; and

supporting a valve leaflet with the second end of each graft extension.

19. The method of claim 18, wherein each graft extension is formed integrally with the graft section.

20. The method of claim 18, wherein the step of supporting a valve leaflet with the second end of each graft extension includes the steps of:

providing an extension support ring; and

attaching the second end of each graft extension to the extension support ring.

21. The method of claim 13, wherein the prosthetic valve has a center valve axis and the graft section has a center graft axis, and the step of securing the prosthetic valve within the annulus of the graft section includes the step of securing the prosthetic valve within the annulus of the graft section with the center valve axis being axially offset from the center graft axis.

22. A minimally invasive method for repairing the function of a diseased valve, the method comprising the steps of:

providing an apparatus including annular first and second support members that are spaced axially apart and are expandable to independent first and second diameters, respectively, the apparatus further including a prosthetic valve and a tubular graft section interconnecting the first and second support members, the graft section defining an annulus having a third diameter that is independent of the first and second diameters, the prosthetic valve being secured within the annulus of the graft section;

collapsing the apparatus and loading it into a sheath for intravascular delivery;

inserting the apparatus into the vasculature and advancing it to a location with the vasculature adjacent the diseased valve;

retracting the sheath and expanding the first and second support members into engagement with the vasculature at the respective first and second diameters; and

forming a seal between at least one of the first and second support members and the vasculature when the support members are expanded;

whereby the suspension of the prosthetic valve inside the graft section at the third diameter and within the vasculature adjacent the diseased valve assumes the function of the diseased valve.

23. The method of claim 22, further comprising the steps of:

providing at least one tubular conduit having oppositely disposed first and second ends;

inserting the at least one tubular conduit into an axial passage through the graft section such that the second end remains in the passage; and

placing the first end of the at least one conduit in a branch blood vessel.

30. The apparatus of claim 23, further comprising at least two graft extensions having first and second ends, the first end of each graft extension being secured to the second graft section and the second end of each graft extension providing support to a valve leaflet.

31. The apparatus of claim 30, wherein each graft extension is formed integrally with the second graft section.

32. The apparatus of claim 30, further comprising an extension support ring, with the second end of each graft extension being attached to the extension support ring.

33. The apparatus of claim 23, wherein the prosthetic valve has a center valve axis, the second graft section has a center graft axis, and the prosthetic valve is secured within the annulus of the second graft section with the center valve axis being axially offset from the center graft axis.

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

an annular support member having inner and outer surfaces, the support member being expandable to a first diameter;

a tubular first graft section for sealing against a vessel wall adjacent the diseased valve, the first graft section being connected to the outer surface of the support member;

a tubular second graft section secured to the inner surface of the support member, the second graft section defining an annulus having a second diameter that is smaller than and independent of the first diameter of the support member; and

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

25. The apparatus of claim 24, further comprising an expandable ring encircling the annulus of the second graft section and supporting the prosthetic valve secured within the annulus.

26. The apparatus of claim 24, wherein the second graft section has an hourglass shape with a neck portion, the neck portion of the graft section defining the annulus.

27. The apparatus of claim 26, wherein the second graft section includes a converging portion and a diverging portion on opposite sides of the neck portion.

28. The apparatus of claim 27, wherein the second graft section includes at least one passage extending axially through the converging and diverging portions.

29. The apparatus of claim 28, 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 second graft section, the first end for positioning in a branch blood vessel.

34. A method for making an apparatus to repair the function of a diseased valve, the method comprising the steps of:

providing an annular support member expandable to a first diameter, the support member having inner and outer surfaces;

connecting a tubular first graft section to the outer surface of the support member for sealing against a vessel wall adjacent the diseased valve;

connecting a tubular second graft section to the inner surface of the support member, the second graft section defining an annulus having a second diameter that is smaller than and independent of the first diameter;

providing a bioprosthetic valve having at least two valve leaflets that are coaptable to permit the unidirectional flow of blood; and

securing the prosthetic valve within the annulus of the second graft section.

35. A minimally invasive method for repairing the function of a diseased valve, the method comprising the steps of:

providing an apparatus including an annular support member having inner and outer surfaces and which is expandable to a first diameter, the apparatus further including a prosthetic valve and first and second tubular graft sections, the first graft section being connected to the outer surface and the second graft section being connected to the outer surface, the second graft section defining an annulus having a second diameter that is smaller than and independent of the first diameter, the prosthetic valve being secured within the annulus of the second graft section;

collapsing the apparatus and loading it into a sheath for intravascular delivery;

inserting the apparatus into the vasculature and advancing it to a location with the vasculature adjacent the diseased valve;

retracting the sheath and expanding the support member into engagement with the vasculature; and

forming a seal between the first graft section and the vasculature when the support member is expanded;

whereby the suspension of the prosthetic valve inside the second graft section at the second diameter and within the vasculature adjacent the diseased valve assumes the function of the diseased valve.

36. The method of claim 35, further comprising the comprising the steps of:

providing at least one tubular conduit having oppositely disposed first and second ends;

inserting the at least one tubular conduit into an axial passage through the second graft section such that the second end remains in the passage; and

placing the first end of the at least one conduit in a branch blood vessel.

37. The method of claim 35, wherein the graft section has an hourglass shape with a neck portion, the neck portion of the graft section defining the annulus.