Techniques for percutaneous mitral valve replacement and sealing

• US 9,017,399 B2
• Filed: 07/21/2011
• Issued: 04/28/2015
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Gross, Yossi, Hacohen, Gil, Miller, Eran, Zipory, Yuval
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/811,308
• Publication Number:
  US 20130172992A1
• Time in Patent Office: 1,377 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623/2.17, 623/2.18, 623/2.36, 623/2.37, 623/2.38, 623/2.4, 623/2.41, 623/2.42, 623/904
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Apparatus and methods are described including a prosthetic valve support (40) configured to be placed at a patient'"'"'s native atrioventricular valve annulus. The valve support defines an annular element (44) that defines an inner cross-sectional area thereof. An expandable prosthetic valve (80) is placed into the patient'"'"'s ventricle, the prosthetic valve including an expandable frame (79) and prosthetic valve leaflets (82) coupled to the frame. When the frame is in a non-constrained state thereof, a cross-sectional area of the frame, along at least a given portion L of the frame'"'"'s length, is greater than the cross-sectional area defined by the annular element. The prosthetic valve is couplable to the prosthetic valve support at any location along the portion, by the frame being expanded when the location along the portion is aligned with the annular element. Other applications are also described.

Claims

1. A method for use with a native valve of a heart of the subject, the native valve having an annulus and being disposed between an atrium of the heart and a ventricle of the heart, the method comprising:

through a sheath, transluminally advancing a prosthetic valve support, in a compressed state thereof, into the atrium;

placing the prosthetic valve support against an atrial surface of the annulus;

inhibiting upstream movement of the prosthetic valve support away from the annulus;

through the sheath, transluminally advancing an expandable prosthetic valve, comprising an expandable frame, to the heart;

deploying a downstream end of the prosthetic valve within the ventricle, the downstream end comprising a plurality of snares;

while upstream movement of the prosthetic valve support is inhibited, sandwiching tissue of the native valve between the snares and the prosthetic valve support by moving the prosthetic valve in an upstream direction, such that at least part of the prosthetic valve is disposed within the prosthetic valve support; and

while the tissue is sandwiched and at least the part of the prosthetic valve is disposed within the prosthetic valve support, expanding the prosthetic valve such that the prosthetic valve becomes held in place with respect to the prosthetic valve support.

2. The method according to claim 1, further comprising anchoring an anchor to the native valve prior to advancement of the prosthetic valve support, and wherein inhibiting upstream movement of the prosthetic valve support away from the annulus comprises coupling the prosthetic valve support to the anchor.

3. The method according to claim 1, wherein inhibiting upstream movement of the prosthetic valve support away from the annulus comprises pushing the prosthetic valve support against the annulus using a pushing element.

4. The method according to claim 1, wherein:

the prosthetic valve comprises a frame that is self-expandable,

advancing the expandable prosthetic valve comprises advancing the expandable prosthetic valve while the expandable prosthetic valve is disposed in a compressed state within an overtube, and

expanding the prosthetic valve comprises facilitating self-expansion of the prosthetic valve by exposing the prosthetic valve from within the overtube.

5. The method according to claim 1, wherein advancing the prosthetic valve comprises advancing the prosthetic valve independently of advancing the prosthetic valve support.

6. The method according to claim 1, wherein advancing the prosthetic valve comprises advancing the prosthetic valve subsequently to advancing the prosthetic valve support.

7. The method according to claim 1, wherein the steps of advancing the prosthetic valve support, placing the prosthetic valve support, inhibiting upstream movement, advancing the prosthetic valve, deploying the downstream end of the prosthetic valve, sandwiching the tissue, and expanding the prosthetic valve, are performed without the use of cardiopulmonary bypass.

8. The method according to claim 1, wherein placing the prosthetic valve support against the atrial surface of the annulus comprises placing the prosthetic valve support against the atrial surface of the annulus while the native valve continues to function.

9. The method according to claim 1, wherein expanding the prosthetic valve comprises expanding the prosthetic valve until the expansion of the prosthetic valve is constrained by the prosthetic valve support.