APPARATUS AND METHOD FOR REPAIRING THE FUNCTION OF A DISEASED VALVE

• US 20170165059A1
• Filed: 12/08/2016
• Published: 06/15/2017
• Est. Priority Date: 12/14/2015
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Roselli, Eric E., Johnston, Douglas R.
• Granted Patent: US 10,335,272 B2
• Time in Patent Office: Days
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0064 Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An apparatus for repairing the function of a diseased valve includes a tubular first support member which is expandable to a first average diameter and has oppositely disposed proximal and distal first support member ends. A tubular second support member is spaced axially apart from the first support member and is expandable to a second average diameter that is smaller than the first average diameter. The second support member has oppositely disposed proximal and distal second support member ends. A tubular graft section interconnects the first and second support members and has oppositely disposed proximal and distal graft section ends axially spaced apart by a graft section body. The proximal graft section end is connected directly to the distal first support member end and the distal graft section end is connected directly to the proximal second support member end.

Claims

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

a tubular first support member expandable to a first average 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 average diameter that is smaller than the first average diameter, the second support member having oppositely disposed proximal and distal second support member ends; and

a tubular graft section interconnecting the first and second support members and defining an annulus axially spaced from both the first and second support members, the tubular graft section having oppositely disposed proximal and distal graft section ends axially spaced apart by a graft section body, 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, a diameter of the tubular graft section at the proximal graft section end being larger than a diameter of the tubular graft section at the distal graft section end.

2. The apparatus of claim 1, including 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.

3. The apparatus of claim 1, wherein the graft section underlies and is secured to an inner 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 underlies and is secured to an inner surface of the other of the first and second support members.

5. The apparatus of claim 1, including a tubular third support member spaced axially apart from, and distal to, the first support member and expandable to a third average diameter that is substantially similar to the first average diameter, the third support member having oppositely disposed proximal and distal third support member ends, the third support member being connected directly to the graft section body.

6. The apparatus of claim 5, wherein the graft section underlies and is secured to an inner surface of the third support member.

7. The apparatus of claim 5, wherein the graft section body includes at least one graft aperture penetrating therethrough, the graft aperture being located axially between circumferentially corresponding portions of axially adjacent ones of the first, second, and third support members.

8. The apparatus of claim 7, wherein each of the first, second, and third support members includes a plurality of distally-oriented peaks and proximally-oriented valleys, and wherein a plurality of graft apertures are configured to divide the graft section body circumferentially between the graft apertures into a plurality of graft bridges oriented in a substantially axial direction and extending between circumferentially aligned distally-oriented peaks and proximally-oriented valleys of axially adjacent ones of the first, second, and third support members.

9. The apparatus of claim 1, wherein the proximal first support member end is axially spaced proximally from the proximal graft section end.

10. The apparatus of claim 1, including a tubular fourth support member spaced axially apart from, and proximal to, the second support member and expandable to a fourth average diameter that is substantially similar to the second average diameter, the fourth support member having oppositely disposed proximal and distal fourth support member ends, the fourth support member being connected directly to the graft section body.

11. The apparatus of claim 10, wherein the graft section underlies and is secured to an inner surface of the fourth support member.

12. The apparatus of claim 1, wherein the graft section is the only structure directly connecting the first and second support members together.

13. The apparatus of claim 10, wherein the graft section body includes at least one graft aperture penetrating therethrough, the graft aperture being located axially between circumferentially corresponding portions of axially adjacent ones of the first, second, third, and fourth support members.

14. The apparatus of claim 13, wherein each of the first, second, third, and fourth support members includes a plurality of distally-oriented peaks and proximally-oriented valleys, and wherein a plurality of graft apertures are configured to divide the graft section body circumferentially between the graft apertures into a plurality of graft bridges oriented in a substantially axial direction and extending between circumferentially aligned distally-oriented peaks and proximally-oriented valleys of axially adjacent ones of the first, second, third, and fourth support members.

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

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

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

providing a tubular graft section having oppositely disposed proximal and distal graft section ends axially spaced apart by a graft section body, a diameter of the tubular graft section at the proximal graft section end being larger than a diameter of the tubular graft section at the distal graft section end;

interconnecting the first and second support members with the graft section;

with the graft section, defining an annulus axially spaced from both the first and second support members;

connecting the proximal graft section end directly to the distal first support member end; and

connecting the distal graft section end directly to the proximal second support member end.

16. The method of claim 15, including:

providing a prosthetic 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 with the first and second support members being interconnected only by the graft section, and the prosthetic valve being directly secured only to the graft section.

17. The method of claim 15, wherein interconnecting the first and second support members with the graft section includes arranging the graft section underlying and secured to an inner surface of at least one of the first and second support members.

18. The method of claim 15, wherein interconnecting the first and second support members with the graft section includes:

arranging the graft section overlapping and secured to an outer surface of one of the first and second support members; and

arranging the graft section underlying and secured to an inner surface of the other of the first and second support members.

19. The method of claim 15, including:

providing a tubular third support member spaced axially apart from, and distal to, the first support member and expandable to a third average diameter that is substantially similar to the first average diameter, the third support member having oppositely disposed proximal and distal third support member ends; and

connecting the third support member directly to the graft section body.

20. The method of claim 19, including arranging the graft section underlying and secured to an inner surface of the third support member.

21. The method of claim 15, including penetrating the graft section body with at least one graft aperture, the graft aperture being located axially between circumferentially corresponding portions of axially adjacent ones of the first, second, and third support members.

22. The method of claim 21, wherein each of the first, second, and third support members includes a plurality of distally-oriented peaks and proximally-oriented valleys, and including:

with a plurality of graft apertures, dividing the graft section body circumferentially between the graft apertures into a plurality of graft bridges oriented in a substantially axial direction and extending between circumferentially aligned distally-oriented peaks and proximally-oriented valleys of axially adjacent ones of the first, second, and third support members.

23. The method of claim 15, wherein connecting the proximal graft section end directly to the distal first support member end includes axially spacing the proximal first support member end proximally from the proximal graft section end.

24. The method of claim 15, including:

providing a tubular fourth support member spaced axially apart from, and proximal to, the second support member and expandable to a fourth average diameter that is substantially similar to the second average diameter, the fourth support member having oppositely disposed proximal and distal fourth support member ends; and

connecting the fourth support member directly to the graft section body.

25. The method of claim 24, including arranging the graft section underlying and secured to an inner surface of the fourth support member.

26. The method of claim 24, including penetrating the graft section body with at least one graft aperture, the graft aperture being located axially between circumferentially corresponding portions of axially adjacent ones of the first, second, third, and fourth support members.

27. The method of claim 26, wherein each of the first, second, third, and fourth support members includes a plurality of distally-oriented peaks and proximally-oriented valleys, and including:

with a plurality of graft apertures, dividing the graft section body circumferentially between the graft apertures into a plurality of graft bridges oriented in a substantially axial direction and extending between circumferentially aligned distally-oriented peaks and proximally-oriented valleys of axially adjacent ones of the first, second, third, and fourth support members.