Retaining mechanisms for prosthetic valves

• US 8,597,348 B2
• Filed: 11/28/2012
• Issued: 12/03/2013
• 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:
  US13/687,960
• Publication Number:
  US 20130090726A1
• Time in Patent Office: 370 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

A method of treating a deficient mitral valve without open heart surgery is disclosed. A support band is advanced from a delivery catheter and positioned around native leaflets of the deficient mitral valve. The support band is preferably formed of a shape memory material and is configured to assume a curved shape upon advancement from the delivery catheter. While the support band is positioned around the native leaflets of the mitral valve, an expandable prosthetic heart valve is delivered through an apex of the left ventricle and into the mitral valve. The expandable prosthetic heart valve is then expanded within the mitral valve, thereby causing one or more of the native leaflets of the mitral valve to be frictionally secured between the support band and the prosthetic heart valve.

Claims

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

percutaneously inserting a guide catheter into a vasculature of a patient;

advancing the guide catheter into an aortic arch;

advancing a first catheter and a second catheter through the guide catheter into a left ventricle;

looping the first catheter and the second catheter at least partially around chordae tendineae in the left ventricle;

advancing a guidewire through the first catheter and the second catheter, the guidewire looping at least partially around the chordae tendineae;

withdrawing the first catheter and the second catheter;

attaching a cord of biocompatible material to the guidewire, the cord of biocompatible material comprising a first end and a second end, the first end comprising a first part of a snap-fit connection and the second end comprising a second part of a snap-fit connection, the cord of biocompatible material comprising a biocompatible alloy;

advancing the cord of biocompatible material into the left ventricle over the guidewire;

pulling the cord of biocompatible material in a partial loop around the chordae tendineae using the guidewire;

urging the first end and the second end of the cord of biocompatible material together into a closed loop,

locking the first part of the snap-fit connection at the first end of the cord to the second part of the snap-fit connection at the second end of the cord, thereby providing a support band;

withdrawing the guidewire;

positioning and holding the support band around native leaflets of a native mitral valve on the outflow side of the native mitral valve;

advancing a third catheter into the left ventricle, the third catheter carrying a prosthetic heart valve;

positioning the prosthetic heart valve within the support band and the annulus of the native mitral valve; and

balloon expanding the prosthetic heart valve, thereby pinching the native mitral valve leaflets between the prosthetic heart valve and the support band, securing the prosthetic heart valve within the annulus of the native mitral valve for treating the deficient native mitral valve.

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

advancing a first catheter and a second catheter into a left ventricle;

looping the first catheter and the second catheter at least partially around chordae tendineae in the left ventricle;

advancing a guidewire through the first catheter and the second catheter, the guidewire looping at least partially around the chordae tendineae;

attaching a cord of biocompatible material to the guidewire, the cord of biocompatible material comprising a first end and a second end;

positioning the cord of biocompatible material in a partial loop around the chordae tendineae using the guidewire;

locking the first end of the cord of biocompatible material to the second end of the cord of biocompatible material, thereby providing a support band;

positioning and holding the support band around native leaflets of a native mitral valve on the outflow side of the native mitral valve;

advancing a third catheter into the left ventricle, the third catheter carrying a prosthetic heart valve; and

deploying the prosthetic heart valve within the support band and the annulus of the native mitral valve, thereby pinching the native mitral valve leaflets between the prosthetic heart valve and the support band, securing the prosthetic heart valve within the annulus of the native mitral valve, and treating the deficient native mitral valve.

3. The method of claim 2, further comprising inserting a guide catheter into a vasculature of a patient and advancing the first catheter and the second catheter through the guide catheter.

4. The method of claim 2, wherein advancing a first catheter and a second catheter into a left ventricle comprises advancing a first catheter and a second catheter percutaneously or transapically.

5. The method of claim 2, wherein attaching a cord of biocompatible material to the guidewire comprises attaching a cord of biocompatible material comprising at least one of a biocompatible shape memory metal, a biocompatible alloy, or a synthetic biocompatible material.

6. The method of claim 2, wherein attaching a cord of biocompatible material to the guidewire, the cord of biocompatible material comprising a first end and a second end, comprises attaching a cord of biocompatible material comprising a first end comprising a shoulder and a second end comprising an angled collar, the shoulder engageable with the angled collar.

7. The method of claim 2, wherein attaching a cord of biocompatible material to the guidewire, the cord of biocompatible material comprising a first end and a second end, comprises attaching a cord of biocompatible material comprising a first end comprising a hollow portion and a second end dimensioned to be received in the hollow portion.

8. The method of claim 2, wherein attaching a cord of biocompatible material to the guidewire comprises attaching a cord of biocompatible material that assumes a C-shape in an unconstrained state.

9. The method of claim 2, wherein positioning the cord of biocompatible material in a partial loop around the chordae tendineae using the guidewire comprises pulling the guidewire.

10. The method of claim 2, wherein locking the first end of the cord of biocompatible material to the second end of the cord of biocompatible material comprises securing the first end to the second end using an adjustable locking member.

11. The method of claim 2, wherein locking the first end of the cord of biocompatible material to the second end of the cord of biocompatible material, thereby providing a support band comprises adjusting a diameter of the support band.

12. The method of claim 2, wherein deploying the prosthetic heart valve within the support band and the annulus of the native mitral valve comprises balloon expanding the prosthetic heart valve.

13. The method of claim 2, wherein deploying the prosthetic heart valve within the support band and the annulus of the native mitral valve comprises allowing the prosthetic heart valve to self-expand.

14. The method of claim 2, wherein deploying the prosthetic heart valve comprises delivering the prosthetic heart valve percutaneously or transapically.

15. A method of treating a deficient mitral valve without open heart surgery, the method comprising:

advancing a support band from a delivery catheter, the support band having a first end and a second end, the support band stretched into a linear form within the delivery catheter, the support band assuming a curved shape upon ejection from the delivery catheter for surrounding native leaflets of a deficient mitral valve, the support band curved circumferentially around the native leaflets with the first end of the support band proximal to the second end, the support band formed of a shape memory material;

positioning an expandable prosthetic heart valve within an interior of the mitral valve while the prosthetic heart valve is in a compressed shape; and

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

16. The method of claim 15, wherein the support band forms a C-shape.

17. The method of claim 15, wherein the support band is hollow.

18. The method of claim 15, wherein the prosthetic heart valve is delivered through an apex of the left ventricle while in the compressed shape.

19. The method of claim 18, wherein the support band and the prosthetic heart valve are delivered separately using separate catheters.

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

looping a guidewire at least partially around chordae tendineae in the left ventricle;

attaching a cord of biocompatible material to the guidewire, the cord of biocompatible material comprising a first end and a second end;

positioning the cord of biocompatible material in a partial loop around the chordae tendineae using the guidewire;

locking the first end of the cord of biocompatible material to the second end of the cord of biocompatible material, thereby providing a support band;

positioning and holding the support band around native leaflets of a native mitral valve on the outflow side of the native mitral valve; and

deploying a prosthetic heart valve within the support band and the annulus of the native mitral valve, thereby pinching the native mitral valve leaflets between the prosthetic heart valve and the support band, securing the prosthetic heart valve within the annulus of the native mitral valve, and treating the deficient native mitral valve.