Retaining mechanisms for prosthetic valves and methods for using

• US 8,323,335 B2
• Filed: 02/10/2009
• Issued: 12/04/2012
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton, Maisano, Francesco, Meiri, Oded
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/368,891
• Publication Number:
  US 20090319037A1
• Time in Patent Office: 1,393 Days
• Field of Search: 623/2.1, 623/2.11, 128/898
• US Class Current: 623/2.11
• 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

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve.

Claims

1. A method of treating aortic insufficiency, comprising:

delivering a support structure to an outflow side of an aortic valve of a patient, the support structure comprising an annular body defining an interior;

positioning the annular body around leaflets of the aortic valve such that the leaflets of the aortic valve are located within the interior of the annular body and the annular body circumscribes the leaflets of the aortic valve;

after positioning the annular body around the leaflets of the aortic valve, delivering an expandable prosthetic heart valve to a vicinity of the aortic valve, the prosthetic heart valve being advanceable independently of the support structure;

advancing the expandable prosthetic heart valve into the interior of the annular body while the annular body is maintained in a substantially fixed position relative to the aortic valve; and

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

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

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

4. 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.

5. 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.

6. The method of claim 1, wherein the support structure is a support stent, and wherein the act of delivering the support structure 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 stent in a compressed state; and

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

7. The method of claim 1, wherein the act of delivering the support structure comprises guiding the support structure to the outflow side of the aortic valve and into a desired orientation, wherein the desired orientation aligns peaks of the support structure with either the tips or the commissures of the leaflets.

8. The method of claim 1, further comprising disconnecting the support structure from at least a delivery catheter once the leaflets of the aortic valve are frictionally secured between the inner surface of the annular body and the outer surface of the prosthetic heart valve.

9. The method of claim 8, 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 structure.

10. The method of claim 8, wherein the disconnecting comprises cutting through material used to form the support structure.

11. The method of claim 1, wherein the act of expanding the expandable prosthetic heart valve comprises inflating a balloon of a balloon catheter, the expandable prosthetic heart valve being disposed around the balloon of the balloon catheter.