Techniques for percutaneous mitral valve replacement and sealing

• US 9,763,657 B2
• Filed: 04/17/2015
• Issued: 09/19/2017
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Hacohen, Gil, Gross, Yossi, Miller, Eran, Zipory, Yuval, Reich, Tal
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/689,608
• Publication Number:
  US 20150216661A1
• Time in Patent Office: 886 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

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 disposed between an atrium and a ventricle of a heart of a subject, and having an annulus, leaflets, and first and second commissures, the method comprising, without use of cardiopulmonary bypass:

transluminally advancing an annular element, in a collapsed state thereof, toward the native valve;

expanding the annular element within the atrium;

securing the annular element against an atrial surface of the annulus, by anchoring a first anchor to a ventricular surface of the first commissure, and anchoring a second anchor to a ventricular surface of the second commissure, such that each anchor of the first and second anchors extends atrially through the respective commissure, and is attached within the atrium to the annular element;

advancing through a catheter a prosthetic valve in a compressed state thereof, and introducing the prosthetic valve into the heart independently of the advancing of the annular element; and

subsequently to the step of securing, coupling the prosthetic valve to the annular element by expanding the prosthetic valve within the annular element.

2. The method according to claim 1, wherein the annular element includes (i) a support frame that includes a plurality of metallic struts arranged in a circumferentially-repeating pattern, and (ii) a fabric covering that at least partly covers the support frame, and wherein transluminally advancing the annular element comprises transluminally advancing the annular element that includes the support frame and the fabric covering.

3. The method according to claim 2, wherein:

the annular element has a first side and a second side,

the fabric covering covers at least the second side of the annular element, and

securing the annular element against the atrial surface of the annulus comprises securing the annular element such that the fabric covering is disposed against the atrial surface of the annulus.

4. The method according to claim 1, wherein the step of securing the annular element comprises securing the annular element such that the annular element is disposed entirely within the atrium.

5. The method according to claim 1, further comprising transluminally advancing the first anchor and the second anchor toward the native valve while the first anchor and the second anchor are in respective compressed states thereof, and wherein (i) anchoring the first anchor comprises expanding the first anchor at the native valve, and (ii) anchoring the second anchor comprises expanding the second anchor at the native valve.

6. The method according to claim 1, wherein expanding the annular element comprises expanding the annular element such that the annular element has an outer diameter of 30-60 mm, and wherein expanding the prosthetic valve within the annular element comprises expanding the prosthetic valve to a maximum diameter of less than 25 mm.

7. The method according to claim 1, wherein expanding the annular element comprises expanding the annular element such that the annular element has an outer diameter of 30-60 mm, and wherein expanding the prosthetic valve within the annular element comprises expanding the prosthetic valve within the annular element such that the prosthetic valve defines a cross-sectional area that is not more than 90% of an area defined by the annulus of the native valve.

8. The method according to claim 1, wherein expanding the annular element comprises expanding the annular element such that the annular element is too large to pass through the annulus of the native valve.

9. A method for use with a native valve disposed between an atrium and a ventricle of a heart of a subject, and having an annulus, leaflets, and first and second commissures, the method comprising, without use of cardiopulmonary bypass:

transluminally advancing an annular element, in a collapsed state thereof, toward the native valve;

expanding the annular element within the atrium;

securing the annular element against an atrial surface of the annulus, by anchoring a first anchor to a ventricular surface of the first commissure, and anchoring a second anchor to a ventricular surface of the second commissure, such that each anchor of the first and second anchors extends atrially through the respective commissure, and is attached within the atrium to the annular element;

advancing through a catheter a prosthetic valve in a compressed state thereof, and introducing the prosthetic valve into the heart independently of the advancing of the annular element; and

subsequently to the step of placing and securing the annular element, coupling the prosthetic valve to the annular element by causing the prosthetic valve to apply radial force to the annular element.

10. The method according to claim 9, wherein the annular element includes (i) a support frame that includes a plurality of metallic struts arranged in a circumferentially-repeating pattern, and (ii) a fabric covering that at least partly covers the support frame, and wherein transluminally advancing the annular element comprises transluminally advancing the annular element that includes the support frame and the fabric covering.

11. The method according to claim 10, wherein:

the annular element has a first side and a second side,

the fabric covering covers at least the second side of the annular element, and

securing the annular element against the atrial surface of the annulus comprises securing the annular element such that the fabric covering is disposed against the atrial surface of the annulus.

12. The method according to claim 9, wherein the step of securing the annular element comprises securing the annular element such that the annular element is disposed entirely within the atrium.

13. The method according to claim 9, further comprising transluminally advancing the first anchor and the second anchor toward the native valve while the first anchor and the second anchor are in respective compressed states thereof, and wherein (i) anchoring the first anchor comprises expanding the first anchor at the native valve, and (ii) anchoring the second anchor comprises expanding the second anchor at the native valve.

14. The method according to claim 9, wherein expanding the annular element comprises expanding the annular element such that the annular element has an outer diameter of 30-60 mm, and coupling the prosthetic valve to the annular element comprises causing the prosthetic valve to apply the radial force to the annular element without expanding the prosthetic valve to have a cross-sectional area that is more than 90% of an area defined by the annulus of the native valve.

15. The method according to claim 9, wherein expanding the annular element comprises expanding the annular element such that the annular element is too large to pass through the annulus of the native valve.