Expandable annuloplasty ring and associated ring holder

• US 10,123,872 B2
• Filed: 08/02/2017
• Issued: 11/13/2018
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Coroneo, Inc.
• Original Assignee: Coroneo, Inc.
• Inventors: Bulman-Fleming, Neil, Lansac, Emmanuel, Nguyen, Trong Tin, Paolitto, Anthony, Paquette, Jonathan, Ranga, Adrian, Valentini, Valerio
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/666,688
• Publication Number:
  US 20170325957A1
• Time in Patent Office: 468 Days
• Field of Search: 623 211- 238
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes

Abstract

Devices and methods are provided for surgical repair of dilated aortic root to restore aortic valve competence while preserving native leaflets. In one aspect of the invention an expandable annuloplasty ring is provided for external placement at the base of a dilated aortic root. The expandable ring is capable of elastically expanding between a first diastolic diameter and a larger second systolic diameter to provide a physiologically representative surgical repair of the aortic root. In a further aspect of the invention, is provided a holder assembly for aortic annuloplasty ring and suitable for other cardiac valve prosthesis. The holder assembly consists of a holder body pivotingly coupled to a handle member through a ball-and-socket arrangement.

Claims

1. A prosthetic device for surgical repair of an aortic valve of a patient, the aortic valve being exposed to alternating diastolic and systolic phases of a cardiac cycle, the aortic valve having a valve axis and contained within a generally tubular aortic root, the aortic valve including a plurality of valve leaflets, the valve leaflets attached to a coronet-shaped valve annulus, the coronet-shaped valve annulus extending circumferentially around the valve axis, the coronet-shaped valve annulus extending in height along the valve axis between a nadir portion at a base of the aortic root and a spaced away commissure portion generally at a sinotubular junction of the aortic root, the aortic root also having a subvalvular region located below the nadir portion and a supravalvular region located above the commissure portion, the aortic root having coronary arteries attached thereto between the subvalvular and supravalvular regions, the prosthetic device comprising:

a subvalvular ring, said subvalvular ring being annular in shape; and

a supravalvular ring, said supravalvular ring being annular in shape;

wherein, said subvalvular and supravalvular rings are configured, in use, as closed-perimeter flexible structures for placement externally around the aortic root, the subvalvular ring at the subvalvular region generally adjacent the nadir portion of the valve annulus, the supravalvular ring at the supravalvular region generally adjacent the commissure portion of the valve annulus, and whereby, in use, the closed-perimeter flexible structures cooperate to constrain the aortic root so as to improve coaptation of the valve leaflets during the diastolic phase of the cardiac cycle.

2. The prosthetic device of claim 1, wherein the subvalvular ring of the prosthetic device is configured with a ring height that is appropriate to allow surgical implantation of the subvalvular ring below the attachment point of the coronary arteries of the aortic root.

3. The prosthetic device of claim 2, wherein the subvalvular ring of the prosthetic device is configured as an elongate flexible open band having a first band end and second band end and a ring-closing member, said open band allowing the placement of the subvalvular ring below the attachment point of the coronary arteries without having to surgically detach the coronary arteries from the aortic root, the ring-closing member operative to couple said first and second band ends to form the closed-perimeter flexible structure of the subvalvular ring.

4. The prosthetic device of claim 2, wherein said subvalvular ring has elastic mechanical properties.

5. The prosthetic device of claim 2, wherein said supravalvular ring has elastic mechanical properties.

6. The prosthetic device of claim 3, wherein the supravalvular ring of the prosthetic device is configured as an elongate flexible member joined at respective core terminal ends to produce a single open band having a first band end and second band end and a ring-closing member, the ring-closing member operative to couple said first and second band ends to form the closed-perimeter flexible structure of the supravalvular ring.

7. The prosthetic device of claim 3, wherein the supravalvular ring has elastic mechanical properties.

8. The prosthetic device of claim 7, wherein the subvalvular ring has elastic mechanical properties.

9. The prosthetic ring of claim 8, wherein the supravalvular ring of the prosthetic device is configured as an elongate flexible member joined at respective core terminal ends to produce a single open band having a first band end and second band end and a ring-closing member, the ring-closing member operative to couple said first and second band ends to form the closed-perimeter flexible structure of the supravalvular ring.

10. The prosthetic device of claim 8, wherein said subvalvular and supravalvular rings are expandable as a function of the different phases of the cardiac cycle, said subvalvular and supravalvular rings being elastically expandable in annular perimeter between a first device configuration in which the aortic root is exposed to the diastolic phase of the cardiac cycle and a second device configuration of larger annular perimeter than said first device configuration in which the aortic root is exposed to a systolic phase of the cardiac cycle, in said first device configuration the prosthetic device having an appropriately sized first perimeter length so as to improve coaptation of the valve leaflets, and in said second device configuration the prosthetic device expands to a second perimeter length greater than said first perimeter length thereby allowing a controlled expansion of the aortic root as the valve leaflets open to allow blood flow through the open aortic valve.

11. The prosthetic device of claim 1, wherein at least one of said subvalvular or supravalvular rings is covered with a flexible fabric.

12. The prosthetic device of claim 11, wherein said fabric is a compliant textile material that allows substantially unhindered expansion of said subvalvular or supravalvular rings as said prosthetic device transitions between said first and second device configurations.

13. The prosthetic device of claim 12, wherein the supravalvular ring is comprised of first and second core members, said first and second core members being annular in shape, and said fabric maintains said first and second core members in a spaced-apart spatial relationship relative to one another in a manner to create an interspaced fabric portion between said core members for receiving a suture through said supravalvular ring during implantation of the prosthetic device to repair the aortic valve.

14. The prosthetic device of claim 13, wherein said fabric is provided with a plurality of circumferentially spaced apart position indicators serving as visual guides during the implantation of said supravalvular ring.

15. The prosthetic device of claim 13, wherein the subvalvular ring is comprised of a core member, said core member being elongate and having a longitudinal opening extending therethrough, and further including fabric extending across said longitudinal opening for receiving a suture through said subvalvular ring during implantation of the prosthetic device to repair the aortic valve.

16. The prosthetic device of claim 15, wherein said first and second core members of the supravalvular ring and said core member of the subvalvular ring are made from a silicone elastomer material, and said fabric is made from a knitted polyester fabric.

17. The prosthetic device of claim 15, wherein said fabric is provided with a plurality of circumferentially spaced apart position indicators serving as visual guides during the implantation of said subvalvular ring.

18. The prosthetic device of claim 10, wherein the prosthetic device expansion between said first and second device configurations is within an expansion range of 8% to 15%.

19. The prosthetic device of claim 10, wherein at least one of said subvalvular or supravalvular rings is configured with a cross-sectional area that varies as a function of the location along said annular perimeter thereof, so as to provide variable flexibility to said subvalvular or supravalvular rings depending on the circumferential location along said closed-perimeter structure thereof.

20. The prosthetic device of claim 10, wherein at least one of said subvalvular or supravalvular rings is reinforced by fibres or filament members thereby producing a fiber-reinforced arrangement, so as to provide a non-linear elasticity to said prosthetic device as it transitions between said first and second device configurations.

21. The prosthetic ring of claim 4, wherein said supravalvular ring has elastic mechanical properties.

22. A prosthetic device for surgical repair of an aortic valve of a patient, the aortic valve being exposed to alternating diastolic and systolic phases of a cardiac cycle, the aortic valve having a valve axis and contained within a generally tubular aortic root, the aortic valve including a plurality of valve leaflets, the valve leaflets attached to a coronet-shaped valve annulus, the coronet-shaped valve annulus extending circumferentially around the valve axis, the coronet-shaped valve annulus extending in height along the valve axis between a nadir portion at a base of the aortic root and a spaced away commissure portion generally at a sinotubular junction of the aortic root, the aortic root also having a subvalvular region located below the nadir portion and a supravalvular region located above the commissure portion, the aortic root having coronary arteries attached thereto between the subvalvular and supravalvular regions, the prosthetic device comprising:

a subvalvular ring;

said subvalvular ring being annular in shape and covered by a flexible fabric, said subvalvular ring being further comprised of an elastic core member, said elastic core member having a longitudinal opening extending therethrough, said fabric extending across said longitudinal opening for receiving a suture through said subvalvular ring during implantation of the prosthetic device to repair the aortic valve; and

a supravalvular ring, said supravalvular ring being annular in shape and covered by a flexible fabric;

wherein, said subvalvular and supravalvular rings are configured, in use, as closed-perimeter flexible structures for placement externally around the aortic root, the subvalvular ring at the subvalvular region generally adjacent the nadir portion of the valve annulus, the supravalvular ring at the supravalvular region generally adjacent the commissure portion of the valve annulus, and whereby, in use, the closed-perimeter flexible structures cooperate to constrain the aortic root so as to improve coaptation of the valve leaflets during the diastolic phase of the cardiac cycle.

23. The prosthetic device of claim 22, wherein the subvalvular ring of the prosthetic device is configured as an elongate flexible open band having a first band end and second band end and a ring-closing member, said open band allowing the placement of the subvalvular ring below the attachment point of the coronary arteries without having to surgically detach the coronary arteries from the aortic root, the ring-closing member operative to couple said first and second band ends to form the closed-perimeter flexible structure of the subvalvular ring.

24. The prosthetic device of claim 23, wherein the supravalvular ring is comprised of first and second elastic core members, said first and second elastic core members being annular in shape, said fabric of the supravalvular ring coupled to each of said first and second core members, said fabric of the supravalvular ring maintaining said first and second core members in a spaced-apart spatial relationship relative to one another in a manner to create an interspaced fabric portion between said elastic core members for receiving a suture through said supravalvular ring during implantation of the prosthetic device to repair the aortic valve.

25. The prosthetic device of claim 24, wherein said subvalvular and supravalvular rings are expandable as a function of the different phases of the cardiac cycle, said subvalvular and supravalvular rings being elastically expandable in annular perimeter between a first device configuration in which the aortic root is exposed to the diastolic phase of the cardiac cycle and a second device configuration of larger annular perimeter than said first device configuration in which the aortic root is exposed to a systolic phase of the cardiac cycle, in said first device configuration the prosthetic device having an appropriately sized first perimeter length so as to improve coaptation of the valve leaflets, and in said second device configuration the prosthetic device expands to a second perimeter length greater than said first perimeter length thereby allowing a controlled expansion of the aortic root as the valve leaflets open to allow blood flow through the open aortic valve.