Methods for retaining a prosthetic heart valve

• US 9,993,338 B2
• Filed: 04/15/2016
• Issued: 06/12/2018
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Maisano, Francesco, Meiri, Oded
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US15/130,433
• Publication Number:
  US 20160228248A1
• Time in Patent Office: 788 Days
• Field of Search: 623 211
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A prosthetic valve system for replacing a native aortic valve exhibiting regurgitation comprises a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure is radially collapsible and expandable, and deployable on an outflow side of the native aortic valve, circumscribing the native leaflets of the aortic valve. The THV is radially collapsible and expandable, and deployable in an annulus of the native aortic valve to frictionally engage the native leaflets between an interior surface of the support structure and the THV.

Claims

1. A method of retaining a prosthetic heart valve at a native aortic valve having three aortic valve leaflets and three intermediate commissures, comprising:

delivering a support member to an outflow side of a native aortic valve of a patient, the support member comprising an annular body sized such that it can be positioned within the aorta of a patient and around the native aortic valve leaflets, the support member defining three peaks and three valleys;

orienting the support member so that the three peaks are adjacent to the commissures and the valleys are adjacent to the leaflets of the aortic valve;

after positioning the support member around the leaflets of the aortic valve and while the support member is retained by a delivery system component, delivering an expandable prosthetic heart valve to within the aortic valve leaflets, the prosthetic heart valve being advanceable independently of the support member; and

expanding the expandable prosthetic heart valve into contact with the leaflets of the aortic valve, thereby causing the leaflets to be secured between an inner surface of the support member and an outer surface of the prosthetic heart valve.

2. The method of claim 1, wherein the valleys of the support member have greater radii than the peaks.

3. The method of claim 1, wherein the support member is self-expandable.

4. The method of claim 1, wherein the expandable prosthetic heart valve is delivered from an inflow side of the aortic valve.

5. The method of claim 1, wherein the expandable prosthetic heart valve is delivered from the outflow side of the aortic valve.

6. The method of claim 1, wherein the act of delivering the expandable prosthetic heart valve comprises delivering the prosthetic heart valve through a left ventricle of the patient'"'"'s heart.

7. The method of claim 1, wherein the act of delivering the expandable prosthetic heart valve comprises delivering the prosthetic heart valve through the patient'"'"'s aorta.

8. The method of claim 1, wherein the act of delivering the support member comprises:

advancing a first catheter through an aortic arch of the patient so that a distal end of the first catheter is near the aortic valve of the patient, the first catheter at least partially enclosing a stent-delivery catheter, an inner catheter, and the support member in a compressed state; and

;

advancing the stent-delivery catheter and the inner catheter through the first catheter, thereby causing the support member to be deployed from the distal end of the first catheter and to expand into an uncompressed state.

9. The method of claim 1, further comprising disconnecting the support member from a delivery catheter once the leaflets of the aortic valve are frictionally secured between the inner surface of the support member and the outer surface of the prosthetic heart valve.

10. The method of claim 9, wherein the disconnecting comprises retracting an inner catheter relative to a stent-delivery catheter, thereby retracting inner prongs coupled to the inner catheter from corresponding apertures in retaining arms of the support member.

11. A method of retaining a prosthetic heart valve at a native valve having leaflets, comprising:

delivering a support member to an outflow side of a native valve of a patient, the support member comprising an annular body sized such that it can be positioned around the native valve leaflets;

after positioning the support member around the native valve leaflets, delivering an expandable prosthetic heart valve to within the valve leaflets and while the support member is retained by a delivery system component, the prosthetic heart valve being advanceable independently of the support member; and

expanding the expandable prosthetic heart valve into contact with the native valve leaflets, thereby causing the leaflets to be pinched between an inner surface of the support member and an outer surface of the prosthetic heart valve.

12. The method of claim 11, wherein the native valve is an aortic valve having three aortic valve leaflets and three intermediate commissures, and wherein the support member has three valleys and three peaks, the valleys being oriented adjacent the valve leaflets.

13. The method of claim 12, wherein the valleys of the support member have greater radii than the peaks.

14. The method of claim 11, wherein the support member is self-expandable.

15. The method of claim 11, wherein the expandable prosthetic heart valve is delivered from the outflow side of the native valve.

16. The method of claim 11, wherein the act of delivering the support member comprises delivering the support member transapically through a left ventricle of the patient'"'"'s heart.

17. The method of claim 16, wherein the act of delivering the expandable prosthetic heart valve comprises delivering the prosthetic heart valve transapically through a left ventricle of the patient'"'"'s heart.

18. The method of claim 11, wherein the native valve is a mitral valve and the support member surrounds the chordae tendineae of the mitral leaflets.

19. The method of claim 18, wherein the support member is delivered using two catheters.

20. The method of claim 11, wherein the support member is formed from Nitinol.