Techniques for percutaneous mitral valve replacement and sealing

• US 10,512,456 B2
• Filed: 08/30/2017
• Issued: 12/24/2019
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil, Gross, Yossi, Reich, Tal
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US15/691,032
• Publication Number:
  US 20170360426A1
• Time in Patent Office: 846 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0041 J-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

A transluminal sheath is advanced transfemorally into a left atrium of a heart of the subject. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the atrium, and toward a commissure of the mitral valve. A helix is implanted at the mitral valve by advancing the helix out of the surrounding-sheath and through the commissure into a left ventricle of the subject, such that the helix wraps around at least some chordae tendineae of the mitral valve. A prosthetic valve is collapsed into a collapsed state, and subsequently to implanting the helix and collapsing the prosthetic valve, the prosthetic valve is advanced, in its collapsed state, through the transluminal sheath to the mitral valve. The prosthetic valve is implanted in the mitral valve by expanding it such that the helix facilitates anchoring of the prosthetic valve and sealing of the commissure.

Claims

1. A method, for use at a mitral valve of a heart of a subject, the method comprising:

advancing a transluminal sheath into a femoral vein of the subject, through an inferior vena cava of the subject, into a right atrium of the subject, and transseptally into a left atrium of the subject;

advancing a surrounding-sheath out of a distal end of the transluminal sheath, into the left atrium, and toward a commissure of the mitral valve;

implanting a helix at the mitral valve by advancing the helix out of the surrounding-sheath and through the commissure into a left ventricle of the subject, such that the helix wraps around at least some chordae tendineae of the mitral valve;

collapsing a prosthetic valve into a collapsed state;

subsequently to implanting the helix and collapsing the prosthetic valve, advancing the prosthetic valve, in its collapsed state, through the transluminal sheath to the mitral valve; and

implanting the prosthetic valve in the mitral valve by expanding the prosthetic valve such that the helix facilitates anchoring of the prosthetic valve and sealing of the commissure,

wherein the method further comprises;

subsequently to implanting the helix, and prior to advancing the prosthetic valve through the transluminal sheath, extracting the surrounding-sheath from the heart.

2. The method according to claim 1, wherein the helix is a conical helix having a wider end and a narrower end, and wherein implanting the helix comprises implanting the conical helix such that the wider end is proximal to the distal end.

3. The method according to claim 1, further comprising implanting a prosthetic valve support at the mitral valve prior to implanting the prosthetic valve, and wherein implanting the prosthetic valve in the mitral valve such that the helix facilitates anchoring of the prosthetic valve and sealing of the commissure, comprises (i) implanting the prosthetic valve support at the mitral valve such that the helix facilitates anchoring of the prosthetic valve support and sealing of the commissure, and (ii) implanting the prosthetic valve in the prosthetic valve support.

4. The method according to claim 1, further comprising, prior to the advancing of the surrounding-sheath, advancing a guide member to the commissure, and wherein advancing the surrounding-sheath comprises sliding the surrounding-sheath around the guide member.