MITRAL VALVE FIXATION DEVICE REMOVAL DEVICES AND METHODS

• US 20170143330A1
• Filed: 02/02/2017
• Published: 05/25/2017
• Est. Priority Date: 03/17/2014
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Wei, Michael F., Kabe, Arundhati, Krishnamurthy, Gaurav, Dell, Kent, Basude, Raghuveer
• Granted Patent: US 10,667,804 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Procedures may be performed on the heart after the installation of a mitral valve fixation device. In order to prepare the heart for such procedures, the fixation device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart. The fixation device may be partitioned so that one portion may remain attached to each leaflet of the mitral valve. In another example, the leaflets may be cut along the edges of the distal element(s) of the fixation device, so as to cut the fixation device from the leaflet(s). Systems and devices for performing such procedures endovascularly are disclosed. Fixation devices with improved access to a release harness are also disclosed.

Claims

1. A system for disabling or removing a mitral valve fixation device, the system comprising:

a catheter with a cutting means disposed at a distal end thereof, and

a catheter with a retaining means disposed at a distal end thereof.

2. The system of claim 1, wherein the system further comprises a catheter with a repairing means disposed at a distal end thereof for affixing a leaflet or leaflets together.

3. The system of claim 1, wherein the retaining means comprises a cone assembly.

4. The system of claim 3, wherein the cone assembly comprises a balloon in the shape of a hollow cone disposed at the distal end of the catheter.

5. The system of claim 3, wherein the retaining means comprises a lasso-type structure for capturing and retaining a fixation device attached to a mitral valve.

6. The system of claim 5, wherein the lasso-type structure comprises an oval or ring-shaped wire that can be adjusted in size, and a helical loop that encircles the oval or ring-shaped wire.

7. A system for disabling or removing a mitral valve fixation device, the system comprising:

a catheter with a cutting assembly disposed at a distal end thereof, and

a catheter with a retaining assembly disposed at a distal end thereof, the retaining assembly being configured to capture the mitral valve fixation device.

8. The system of claim 7, wherein the cutting assembly comprises a blade and a cutting member that are configured to more relative to one another.

9. The system of claim 8, wherein the cutting member comprises a first portion and a second portion, the first portion having a hardness greater than the second portion.

10. The system of claim 7, wherein the retaining assembly comprises a capturing mechanism configured to capture the mitral valve fixation device, the capturing mechanism comprises a flexible member having a ring-shape and being angularly orientated with respect to an elongate member extending from the catheter.

11. The system of claim 10, wherein the flexible member is angularly orientated about 90°

with respect to the elongate member.

12. The system of claim 10, wherein the flexible member is angularly orientated about 45°

to about 135°

with respect to the elongate member.

13. The system of claim 7, wherein the system further comprises a catheter with a staple disposed at a distal end thereof for affixing a leaflet or leaflets together.

14. The system of claim 7, wherein the retaining assembly and the cutting assembly are collectively associated with a cone assembly comprising a balloon in the shape of a hollow cone disposed at the distal end of the catheter.

15. The system of claim 14, wherein the cone assembly further comprises a heating element configured to separate the mitral valve fixation device from leaflet tissue.

16. The system of claim 14, further comprising a suture assembly.

17. A system for disabling or removing a mitral valve fixation device, the system comprising:

a retaining assembly configured to encircle and capture the mitral valve fixation device that coapts leaflets within a heart,

a cutting assembly configured to cooperate with the mitral valve fixation device to separate leaflets within the heart and disable the mitral valve fixation device, and

a repair assembly configured to affix leaflets of the plurality of leaflets following disabling of the mitral valve fixation device.

18. The system of claim 17, wherein the repair assembly comprises a staple deployable from a distal end of a catheter associated with the repair assembly.

19. The system of claim 17, wherein the repair assembly comprises a suture.

20. The system of claim 17, wherein the cutting assembly is configured to cut the mitral valve fixation device or cut leaflets to which the mitral valve fixation device are captured to disable the mitral valve fixation device.