Expandable annuloplasty ring and associated ring holder

• US 9,757,231 B2
• Filed: 08/23/2012
• Issued: 09/12/2017
• 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:
  US13/592,820
• Publication Number:
  US 20130073033A1
• Time in Patent Office: 1,846 Days
• Field of Search: 623 211, 623 236- 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 first elastic core member, said first elastic core member being annular in shape;

a second elastic core member, said second elastic core member being annular in shape; and

a flexible fabric sheath member, said fabric sheath member coupled to each of said first and second elastic core members, forming a closed perimeter, continuous annular assembly, and covering each of said first and second core members, said fabric sheath member maintaining said first and second core members in a spaced-apart spatial relationship relative to one another in a manner to create an annular portion of the fabric sheath member between said elastic core members for receiving suture during implantation to repair the aortic valve;

wherein, said prosthetic device is configured as a closed-perimeter flexible structure for placement externally around the aortic root, at the subvalvular region generally adjacent the nadir portion of the valve annulus, and whereby, in use, the closed-perimeter structure constrains 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 height of the prosthetic device, resulting from the spaced-apart spatial relationship between said first and second core members, is appropriate to allow surgical implantation of said prosthetic device below the attachment point of the coronary arteries to the aortic root.

3. The prosthetic device of claim 2, wherein said first and second core members are expandable as a function of the different phases of the cardiac cycle, said prosthetic device being elastically expandable in annular perimeter between a first device configuration in which the aortic root is exposed to a 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.

4. The prosthetic device of claim 3, wherein said fabric sheath member is a compliant textile material that allows substantially unhindered expansion of said first and second core members as said prosthetic device transitions between said first and second device configurations.

5. The prosthetic device of claim 4, wherein the prosthetic device expansion between said first and second device configurations is within an expansion range of 8-15%.

6. The prosthetic device of claim 1, wherein said elastic core members are made from a silicone elastomer material, and said fabric sheath member is made from a knitted polyester fabric.

7. The prosthetic device of claim 3, wherein at least one of said first or second core members is configured with a cross-sectional area that varies as a function of the location along said closed-perimeter defining said first or second core member, so as to provide variable flexibility to said prosthetic device depending on the circumferential location along said closed-perimeter structure thereof.

8. The prosthetic device of claim 3, wherein at least one of said first or second core members is reinforced by fibres or filament members thereby producing a fiber-reinforced arrangement, so as to provide a non-linear elastic behavior to said prosthetic device as it transitions between said first and second device configurations.

9. The prosthetic device of claim 1, wherein said annular portion of the fabric sheath member is provided with a plurality of circumferentially spaced apart position indicators serving as visual guides during implantation of said prosthetic device.

10. The prosthetic device of claim 1, wherein said prosthetic device further comprises a device holder, said holder demountably coupled to said prosthetic device so as to allow disassembly from said prosthetic device during the implantation thereof to the aortic root, said holder having a cylindrical surface configured and sized for engagement with a mating annular surface on said prosthetic device, said cylindrical surface having a plurality of circumferentially spaced apertures, said apertures communicating with a portion of said annular portion of the fabric sheath member so as to guide the placement of device-anchoring sutures through said prosthetic device during surgical implantation.