Devices and methods for preparing a valve for a transcatheter valve replacement procedure

Patent metadata

Field	Value
Publication number	US-2022323148-A1
Application number	US-202217851984-A
Country	US
Kind code	A1
Filing date	Jun 28, 2022
Priority date	Nov 14, 2018
Publication date	Oct 13, 2022
Grant date	—

Abstract

The disclosure includes methods, systems and devices for severing and optionally removing at least a portion of heart valve leaflets. Leaflets can be partially removed or entirely removed or otherwise, the leaflets can be severed or splayed in such a way as to avoid coronary blockage, LVOT obstruction, or access challenges in procedures where a prosthetic valve is to be implanted within a previously implanted prosthetic valve. The disclosure also relate to numerous devices for and methods of disabling one or more valve ligating devices to provide an unobstructed valve opening so that a prosthetic heart valve can be implanted within the opening. The ligation device(s) is disabled either by removing the ligation device(s) or severing one leaflet so that ligated leaflets can be separated. In some embodiments, the ligation device(s) are severed to disable the ligation device(s).

First claim

What is claimed is:

1 . A system comprising:
a positioning device configured to align a puncturing element in front of a coronary ostium; further wherein the positioning device including: a positioning catheter having a distal end, and a positioning balloon including a first segment and a second segment positioned proximal to a distal end of the positioning catheter and on opposing sides of the positioning catheter; wherein the first and second segments have a deflated state and an inflated state.

2 . The system of claim 1 , wherein the positioning balloon has an irregular shape in the inflated state.

3 . The system of claim 1 , wherein the first and second segments are separated by a strip of adhesive.

4 . The system of claim 3 , wherein the strip of adhesive is positioned at opposite quadrants at the distal end of the positioning catheter.

5 . The system of claim 1 , wherein the positioning catheter includes a first lumen fluidly connected to the first segment and a second lumen fluidly connected to the second segment.

6 . The system of claim 1 , of claim further comprising a frame positioned over the positioning catheter and supporting the positioning balloon.

7 . The system of claim 1 , wherein, in the inflated state, the first segment is smaller than the second segment.

8 . The system of claim 1 further comprising a valve preparation device at least partially positioned within the positioning catheter; wherein the valve preparation device is configured to remove at least a portion of valve leaflets.

9 . The system of claim 8 , wherein the valve preparation device includes one or more of an electrode and a blade.

10 . The system of claim 8 , wherein the valve preparation device can be delivered through the positioning catheter.

11 . A method of preparing a heart valve having a plurality of leaflets and a valve opening, the method comprising:
providing a positioning device including a positioning catheter and a positioning balloon having a first segment and a second segment positioned proximal to a distal end of the positioning catheter and on opposing sides of the positioning catheter; wherein the first and second segments have a deflated state and an inflated state; delivering the positioning device adjacent the heart valve in the deflated state; transitioning the positioning balloon to the inflated state; advancing the positioning balloon to one of the plurality of leaflets; directing a valve preparation device through the positioning catheter and to the one of the plurality of leaflets; and severing the one of the plurality of leaflets.

12 . The method of claim 11 , further comprising the step of forming a hole in one of the plurality of leaflets; wherein a severing device of the valve preparation device is inserted though the positioning catheter and then through the hole to sever portions of the one of the plurality of leaflets.

13 . The method of claim 12 , wherein a guide wire is inserted through the hole and the severing device is directed over the guide wire to the one of the plurality of leaflets.

14 . The method of claim 11 , wherein the first segment and the second segment are inflated separately.

15 . The method of claim 11 , wherein the step of severing the one of the plurality of leaflets is accomplished with a radio frequency powered wire.

16 . The method of claim 11 , wherein, when in the inflated state and positioned on the one of the plurality of leaflets, the positioning balloon provides an opening to an adjacent coronary.

17 . The method of claim 11 , wherein inflation of the positioning balloon centers the positioning catheter with respect to the one of the plurality of leaflets.

18 . The method of claim 11 , wherein the positioning device includes a positioning catheter and a positioning balloon; wherein the method includes guiding the positioning catheter to the one of the plurality of leaflets, inflating the positioning balloon and guiding the valve preparation device through the positioning catheter to the one of the plurality of leaflets.

19 . The method of claim 11 , wherein the positioning device includes first and second guide wires; wherein the first guide wire is inserted within one of a right or left coronary and the second guide wire is inserted within a left ventricle of the heart.

20 . The method of claim 11 , wherein the heart valve is a mitral valve and a clip is securing two leaflets of the mitral valve together; further comprising the step of removing a portion of the at least one of the plurality of leaflets includes removing the clip along with the portion of the at least one of the plurality of leaflets.

Assignees

• Medtronic Inc

Inventors

• Rothstein Paul T
• Greeley Roger D
• Sandstrom Jeffrey D
• Racchini Joel
• Keogh James R

Classifications

• A61B17/12136

  Balloons · CPC title

• A61B2018/00369

  Heart valves · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2017/00292

  mounted on or guided by flexible, e.g. catheter-like, means · CPC title

• A61B17/12122

  within the heart (for closing a cardiac septal defect A61B17/0057) · CPC title