Multipiece prosthetic mitral valve and method

• US 8,236,049 B2
• Filed: 06/18/2010
• Issued: 08/07/2012
• 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:
  US12/818,498
• Publication Number:
  US 20100256751A1
• Time in Patent Office: 781 Days
• Field of Search: 623/2.1, 623/2.11
• 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

A method for replacing a deficient native mitral valve includes positioning a support band around the leaflets of a native mitral valve and expanding a prosthetic heart valve within the native mitral valve. After the prosthetic heart valve is expanded, the leaflets of the native mitral valve are captured between the prosthetic heart valve and the support band. The prosthetic heart valve and support band are delivered into the body as separate and independent components. The prosthetic heart valve and support band may be deliverable into the left ventricle via a transapical approach in a minimally invasive procedure.

Claims

1. A method of treating a deficient native mitral valve, comprising:

inserting an introducer sheath into a left ventricle through a wall of the left ventricle at a location exterior of a space defined by chordae tendineae therein;

locating a distal tip of the introducer sheath adjacent to an outflow side of a native mitral valve;

delivering a support band through the introducer sheath into the left ventricle adjacent the outflow side of the native mitral valve;

positioning the support band to surround native leaflets of the native mitral valve, adjacent to an outflow side of the native mitral valve, the support band carried by a first catheter inserted into the left ventricle through the introducer sheath;

delivering a prosthetic heart valve into an annulus of the native mitral valve, the prosthetic heart valve carried by a second catheter inserted into the left ventricle through the introducer sheath while the position of the support band is maintained by the first catheter, the prosthetic heart valve comprising a radially expandable stent and a valve structure mounted within the expandable stent, the valve structure formed with pericardial tissue, the prosthetic heart valve being separate from the support band;

expanding the stent within the annulus of the native mitral valve and within the support band, thereby engaging the stent with an interior of the support band; and

releasing the support band from the first catheter,

wherein, after the stent is expanded, the native leaflets of the native mitral valve are frictionally secured between an outer wall of the stent and the support band and wherein the valve structure replaces the function of the native mitral valve.

2. The method of claim 1, wherein the support band comprises a cord and an adjustable locking member, the adjustable locking member securing at least two portions of the cord to the adjustable locking member to form the support band.

3. The method of claim 2, wherein the prosthetic heart valve is delivered into the left ventricle before a diameter of the support band is fixed.

4. The method of claim 1, wherein the support band comprises a shape-memory metal.

5. The method of claim 1, wherein releasing the support band comprises cutting through material used to form the support band.

6. The method of claim 1, wherein the stent is a self-expandable.

7. A method for treating a deficient mitral valve, the method comprising:

forming a partial loop around at least some of the chordae tendineae of a native mitral valve with a cord of biocompatible material;

securing a locking member to at least two portions of the cord to form a closed loop;

positioning the closed loop around leaflets of the native mitral valve;

positioning an expandable prosthetic heart valve into an interior of the mitral valve; and

expanding the expandable prosthetic heart valve, thereby causing an exterior surface of the expandable prosthetic heart valve to urge native leaflets of the mitral valve against an interior surface of the closed loop and to frictionally secure the expandable prosthetic heart valve to the native leaflets of the native mitral valve.

8. The method of claim 7, wherein the act of securing a locking member to portions of the cord comprises:

positioning the locking member over the portions of the cord;

advancing the locking member along the portions of the cord, thereby decreasing a diameter of the loop formed by the cord and the locking member; and

securing the locking member to the portions of the cord to form the closed loop,

wherein the closed loop has a substantially fixed diameter and an inner diameter of the closed loop is substantially equal to an outer diameter of the prosthetic heart valve when in an expanded configuration within the native mitral valve.

9. The method of claim 7, further comprising cutting through portions of the cord to release the loop formed by the cord of biocompatible material and the locking member.

10. The method of claim 7, wherein the locking member is attached to the at least two portions of the cord occurs before the expandable prosthetic heart valve is expanded.

11. The method of claim 7, wherein the act of attaching the locking member to the at least two portions of the cord occurs after expanding the expandable prosthetic heart valve.

12. The method of claim 7, further comprising:

unsecuring the locking member from the portions of the cord prior to expanding the prosthetic heart valve;

adjusting the diameter of the loop by moving the locking member along the portions of the cord; and

re-securing the locking member to the portions and forming a second loop with a substantially fixed diameter of a different size.

13. The method of claim 7, wherein the act of forming the partial loop around the chordae tendineae of the patient'"'"'s heart is performed using one or more delivery catheters inserted through the aortic arch of the patient.

14. The method of claim 7, wherein the act of forming the partial loop around the chordae tendineae of the patient'"'"'s heart is performed using one or more delivery catheters inserted through an opening in the left ventricle of the patient.

15. A method for treating a deficient native mitral valve, the method comprising:

advancing a first end of a support band out of a distal end of a first catheter, the support band at least partially encircling the chordae tendineae of a native mitral valve;

receiving the first end of the support band in a distal end of a second catheter;

advancing a locking member over the support band to form a loop;

adjusting a diameter of the loop formed by the support band and the locking member to a desired diameter and securing the locking member to the support band;

advancing an expandable prosthetic heart valve into the mitral valve and the interior of the loop formed by the support band and the locking member while the prosthetic heart valve is in a compressed state; and

expanding the expandable prosthetic heart valve into an uncompressed state, thereby causing one or more native leaflets of the mitral valve to be frictionally secured between the loop and the expandable prosthetic heart valve.

16. The method of claim 15, wherein the first and second catheters are advanced percutaneously through the aortic valve to provide access to the native mitral valve for delivery of the support band.

17. The method of claim 15, wherein the act of forming the loop comprises:

advancing the distal end of the first delivery catheter into the left ventricle of a patient so that a distal portion of the first delivery catheter substantially circumscribes a first half of the patient'"'"'s chordae tendineae;

advancing the distal end of the second delivery catheter into the left ventricle of the patient so that a distal portion of the second delivery catheter substantially circumscribes a second half of the patient'"'"'s chordae tendineae and so that a distal end of the second delivery catheter contacts a distal end of the first delivery catheter, thereby forming a delivery catheter junction;

advancing the first end of the support band through the first delivery catheter, across the delivery catheter junction, and into the second delivery catheter; and

retracting the first delivery catheter and the second delivery catheter from the left ventricle of the patient.