Mitral valve fixation device removal devices and methods

• US 10,667,804 B2
• Filed: 02/02/2017
• Issued: 06/02/2020
• Est. Priority Date: 03/17/2014
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Basude, Raghuveer, Dell, Kent, Kabe, Arundhati, Krishnamurthy, Gaurav, Wei, Michael F.
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US15/423,060
• Publication Number:
  US 20170143330A1
• Time in Patent Office: 1,216 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 for prostheses A61F2210/0014
• 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 that coapts leaflets, the system comprising:

a first catheter with a cutting assembly disposed at a distal end of the first catheter, a portion of the cutting assembly being configured to move longitudinally along the first catheter to cut the leaflet tissue, the cutting assembly comprising a cutting blade and a cutting board, and

a second catheter with a capturing mechanism disposed at a distal end thereof and movable relative to the distal end, the capturing mechanism configured to selectively capture the mitral valve fixation device.

2. The system of claim 1, wherein the system further comprises a third 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 capturing mechanism comprises a lasso-type structure is configured for capturing and retaining a fixation device attached to a mitral valve.

4. The system of claim 3, 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.

5. A system for disabling or removing a mitral valve fixation device that coapts leaflets, the system comprising:

a first catheter with a cutting blade and a cutting board disposed at a distal end of the catheter, an elongate member being configured to move longitudinally along the first catheter to close a gap between the cutting blade and the cutting board to cut leaflet tissue held in apposition by the mitral valve fixation device, and

a second catheter with a capturing mechanism extending from a distal end of a lumen extending to the distal end of the second catheter, the capturing mechanism being selectively expandable and contractable to capture the mitral valve fixation device.

6. The system of claim 5, wherein the capturing mechanism comprises a flexible member having a ring-shape and being angularly orientated with respect to an elongate member extending from the second catheter.

7. The system of claim 6, wherein the flexible member is angularly orientated about 90°

with respect to the elongate member.

8. The system of claim 6, wherein the flexible member is angularly orientated about 45°

to about 135°

with respect to the elongate member.

9. The system of claim 5, further comprising a suture assembly.

10. A system for disabling or removing a mitral valve fixation device that coapts leaflets, the system comprising:

a retaining assembly configured to encircle and capture the mitral valve fixation device that coapts a plurality of leaflets of a heart, the retaining assembly comprising a capturing mechanism extending from a distal opening of a lumen that extends to a distal end of a catheter,

a catheter with a cutting assembly disposed at a distal end of the catheter, the cutting assembly being configured to cooperate with the mitral valve fixation device to separate one or more of the plurality of leaflets of the heart and disable the mitral valve fixation device, the cutting assembly comprising a cutting blade and a cutting board, the cutting board extending from an elongate member extending longitudinally along the catheter to which the cutting blade is mounted, the elongate member being configured to move longitudinally along the catheter, and

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

11. The system of claim 10, wherein the repair assembly comprises a suture.

12. The system of claim 10, wherein the cutting assembly is configured to disable the mitral valve fixation device by cutting the mitral valve fixation device or cutting leaflets captured by the mitral valve fixation device.