Transcatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection device

Patent metadata

Field	Value
Publication number	US-2016242908-A1
Application number	US-201615056599-A
Country	US
Kind code	A1
Filing date	Feb 29, 2016
Priority date	Nov 14, 2006
Publication date	Aug 25, 2016
Grant date	—

Abstract

Devices and methods are disclosed for the treatment or repair of regurgitant cardiac valves, such as a mitral valve. An annuloplasty device can be placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. A protective device can be placed between the annuloplasty device and an underlying coronary artery to inhibit compression of the underlying coronary artery by the annuloplasty device in the coronary sinus. In addition, the protective device can inhibit compression of the coronary artery from inside the heart, such as from a prosthetic mitral valve that exerts radially outward pressure toward the coronary artery. The annuloplasty device can also create an artificial inner ridge or retaining feature projecting into the native mitral valve region to help secure a prosthetic mitral valve.

First claim

1 . A protection device for protecting a coronary artery of a heart from being compressed between a prosthetic mitral valve secured within the mitral valve region of the heart and a mitral annuloplasty tension element extending at least partially through a coronary sinus of the heart over the coronary artery, the protection device comprising:
a protective member comprising a first foot having a first free end, a second foot having a second free end, and an arched portion extending between the first and second feet, the protective member being configured to pass through a transvascular catheter and be implanted within the coronary sinus at a location where the coronary sinus passes over the coronary artery, the protective member being configured to be positioned along an annuloplasty tension element that extends at least partially through the coronary sinus and at least partially around the mitral valve; wherein the arched portion of the protective member has sufficient rigidity and dimensions to bridge over the coronary artery and inhibit application of compressive pressure on the underlying coronary artery by a prosthetic mitral valve positioned within the native mitral valve region of the heart and exerting an outward expansion force on myocardium underlying the coronary artery while the protective member is positioned in the coronary sinus over the coronary artery and the annuloplasty tension element is under tension.

2 . The protection device of claim 1 , wherein the protection device has sufficient dimensions and rigidity to protect the coronary artery from being compressed when a mitral annuloplasty tension element extends at least partially through a coronary sinus over the coronary artery and applies sufficient inward compression on the heart to create a retaining feature projecting inwardly into the native mitral valve region and when a prosthetic mitral valve is positioned within the native mitral valve region exerting an outward expansion force on myocardium underlying the coronary artery and the prosthetic mitral valve is secured using the retaining feature.

3 . The protection device of claim 1 , wherein the arch portion has a height that is greater than a diameter of the coronary artery such that the coronary artery can be protected from compression within the arch portion.

4 . The protection device of claim 1 , wherein the height of the arch portion is at least 3.5 mm.

5 . The protection device of claim 1 , wherein tension from the tension element causes the first and second feet to orient toward the prosthetic mitral valve when the arched portion is positioned over the coronary artery such that the first and second feet receive the expansion force applied by the prosthetic mitral valve and limit the amount of the expansion force received by the coronary artery.

6 . The protection device of claim 1 , wherein first and second feet of the protection member are curved to match the curvature of the heart wall adjacent to the coronary artery.

7 . The protection device of claim 1 , wherein the protection member has a chiral shape.

8 . The protection device of claim 1 , wherein the protection member has a helical, corkscrew, or spiral shape.

9 . The protection device of claim 1 , wherein the arched portion extends substantially perpendicular to the coronary artery when positioned in the coronary sinus over the coronary artery, while the first and second legs extend at oblique angles relative to the coronary artery.

10 . The protection device of claim 1 , wherein the first foot is offset laterally from the second foot and the arch portion curves laterally along its length as it arches over the coronary artery.

11 . The protection device of claim 1 , wherein the arched portion has a length extending from the first foot to the second foot and a width perpendicular to its length and its height, and wherein the width is substantially uniform along the length.

12 . The protection device of claim 1 , wherein the arched portion bridges a maximum linear distance of about 0.6 inches.

13 . The protection device of claim 1 , wherein the protection device is at least partially tubular.

14 . The protection device of claim 1 , further comprising a mitral annuloplasty tension element extending over or through the arched portion of the protection device.

15 . A method comprising:
placing an annuloplasty tensioning element at least partially through a coronary sinus of a heart and over a coronary artery; placing a protection member in the coronary sinus between the annuloplasty tensioning element and the coronary artery with an arched portion of the protection member extending over the coronary artery; applying sufficient tension to the annuloplasty tensioning element to create a retaining feature projecting inwardly into the native mitral valve region of the heart; and implanting a transcatheter prosthetic mitral valve within the native mitral valve region such that the prosthetic mitral valve is secured via the retaining feature and applies an outward expansion force on myocardium underlying the coronary artery; wherein the arched protection member has sufficient rigidity and dimensions to inhibit application of compressive pressure to the coronary artery by the prosthetic heart valve.

16 . The method of claim 15 , wherein the retaining feature is oriented substantially in a plane that is at an oblique angle relative to a plane defined by the native mitral valve annulus.

17 . The method of claim 15 , wherein implanting the transcatheter prosthetic mitral valve comprises delivering the prosthetic mitral valve into the native mitral valve region in a radially compressed configuration and causing the prosthetic mitral valve to radially expand and apply radially expansive pressure on the retaining feature.

18 . The method of claim 15 , wherein placing a protection member in the coronary sinus comprises orienting the arched portion of the protection member such that the arched portion extends perpendicularly across the coronary artery.

19 . A system comprising the protection member of claim 1 , an annuloplasty tensioning element suitable for use with the protection member, and a transcatheter prosthetic mitral valve suitable to be implanted within the native mitral valve region when the annuloplasty tensioning element and the protection member are positioned in the coronary sinus over the coronary artery and applying an inward compressive force on the heart.

20 . The system of claim, wherein the annuloplasty tensioning element is configured to create a retaining feature projecting inwardly into the native mitral valve region when extending at least partially through the coronary sinus and placed under tension, wherein the transcatheter prosthetic mitral valve is configured to be secured to the retaining feature by applying radially outward expansion force on the retaining feature, and the protection member is configured to protect the coronary artery from compression by pressure applied by the expansion force of the prosthetic mitral valve.

Assignees

• Us Health
• Us Health

Inventors

• Kim June-Hong
• Lederman Robert J
• Kocaturk Ozgur

Classifications

• A61F2002/068

  Modifying the blood flow model, e.g. by diffuser or deflector · CPC title

• A61F2/06

  Blood vessels · CPC title

• A61F2/2445 Primary

  Annuloplasty rings in direct contact with the valve annulus · CPC title

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61F2250/0004

  adjustable · CPC title