Prosthetic apparatus for implantation at mitral valve

• US 8,585,755 B2
• Filed: 08/28/2012
• Issued: 11/19/2013
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe E., Oba, Travis Zenyo, Yi, Seung-Beom, Geist, Stephen C.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/597,122
• Publication Number:
  US 20120323316A1
• Time in Patent Office: 448 Days
• Field of Search: 623 21- 219, 623 124- 126, 606/108
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Embodiments of prosthetics configured for implanting in at the native mitral valve region of the heart include a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Methods and apparatus for delivering and implanting the prosthetic valve are also described.

Claims

1. A method of implanting a prosthetic apparatus at the native mitral valve region of the heart, the native mitral valve having a native annulus and native valve leaflets, the method comprising:

positioning a main body of the prosthetic apparatus in a radially compressed state within the native annulus;

deploying at least one ventricular anchor such that an engagement portion of the ventricular anchor is positioned behind one of the native valve leaflets and contacts a ventricular surface of the native annulus;

allowing the main body to expand from the radially compressed state to a radially expanded state within the native annulus; and

deploying at least one atrial anchor such that an engagement portion of the atrial anchor contacts an atrial surface of the native annulus, the engagement portions of the atrial anchor and the ventricular anchor contacting the native annulus at locations on opposite sides of the native annulus;

wherein the native valve leaflets are free to seal around the main body during systole to prevent blood from flowing toward the left atrium, and wherein the native valve leaflets are free to separate from the main body during diastole to allow blood to flow around the main body into the left ventricle.

2. The method of claim 1, wherein deploying the at least one ventricular anchor comprises retracting a delivery sheath from around the ventricular anchor to allow the ventricular anchor to resiliently move from a delivery position, in which the ventricular anchor extends from the main body in a ventricular direction, to a deployed position, in which the anchor extends from the main body in an atrial direction behind the native valve leaflet.

3. The method of claim 1, wherein deploying at least one ventricular anchor comprises deploying an anterior ventricular anchor such that an engagement portion of the anterior ventricular anchor is positioned behind the anterior native valve leaflet, and deploying a posterior ventricular anchor such that an engagement portion of the posterior ventricular anchor is positioned behind the posterior native valve leaflet.

4. The method of claim 1, wherein the main body comprises a crescent shaped body having a concave anterior side and a convex posterior side when the main body is in the radially expanded state.

5. The method of claim 4, wherein positioning the main body within the native annulus comprises positioning the concave anterior side of the main body facing the anterior native valve leaflet and positioning the convex posterior side of the main body facing the posterior native valve leaflet, such that the native valve leaflets can seal around the main body during systole to prevent mitral regurgitation.

6. The method of claim 5, wherein the main body comprises a prosthetic valve.

7. The method of claim 1, wherein the native valve leaflet between the ventricular anchor and the main body has a free edge extending from one commissure of the native mitral valve to the other commissure of the native mitral valve, and wherein the entire free edge is allowed to separate from the main body during diastole and then seal around the main body during systole.

8. A method for implanting a prosthetic apparatus at the native mitral valve region of a heart, the native mitral valve having a native annulus, posterior and anterior native valve leaflets, first and second commissures, a first group of chordae tendinae connected to the native leaflets at the first commissure, and a second group of chordae tendinae connected to the native leaflets at the second commissure, the method comprising:

positioning a main body of the prosthetic apparatus in a radially compressed state within the native annulus;

positioning an atrial anchor of the prosthetic apparatus within the left atrium so as to engage an atrial surface of the native annulus;

positioning a first ventricular anchor of the prosthetic apparatus behind the anterior native valve leaflet;

positioning a second ventricular anchor of the prosthetic apparatus behind the posterior native valve leaflet; and

allowing the main body to self-expand from the radially compressed state to an expanded state contacting inner surfaces of the native valve leaflets.

9. The method of claim 8, wherein the second ventricular anchor and first ventricular anchor are on diametrically opposed sides of the main body.

10. The method of claim 9, wherein:

positioning the first ventricular anchor comprises positioning the first ventricular anchor behind the A2 region of the anterior native valve leaflet at a location between the first and second groups of chordae tendinae; and

positioning the second ventricular anchor comprises positioning the second ventricular anchor behind the P2 region of the posterior native valve leaflet at a location between the first and second groups of chordae tendinae.

11. The method of claim 9, wherein an intermediate portion of the anterior native valve leaflet is pinched between the first ventricular anchor and an outer surface of the main body, and an intermediate portion of the posterior native valve leaflet is pinched between the second ventricular anchor and an outer surface of the main body.

12. The method of claim 11, wherein the prosthetic apparatus is implanted such that:

during diastole, the intermediate portions of the anterior and posterior native valve leaflets remain in contact with the outer surface of the main body while portions of the native valve leaflets adjacent to the first and second commissures are allowed to separate from each other and from the outer surface of the main body to allow blood to flow therebetween toward the left ventricle; and

during systole, the portions of the native valve leaflets adjacent to the first and second commissures are urged against each other and against the outer surface of the main body to prevent blood from flowing toward the left atrium between the outer surface of the main body and the native valve leaflets.

13. The method of claim 8, wherein the prosthetic apparatus comprises a valve portion coupled within the main body, the valve portion comprising prosthetic valve leaflets that form a one-way valve within the main body that allows blood to flow through the main body in a direction toward the left ventricle during diastole and prevents blood from flowing through the main body in a direction toward the left atrium during systole.

14. The method of claim 13, wherein the main body comprises an atrial end and a ventricular end, the prosthetic valve leaflets are positioned between the atrial end and the ventricular end, and the ventricular anchors extend from the ventricular end toward the atrial end of the main body.

15. The method of claim 14, wherein each of the ventricular anchors comprises an elongated member having first and second fixed end portions secured to the ventricular end of the main body, first and second intermediate portions that extend from the first and second fixed end portions, respectively, toward the atrial end of the main body, and a bent portion interconnecting the first and second intermediate portions, the bent portion forming a free end portion of the anchor.

16. The method of claim 15, wherein each of the first and second fixed end portions extends from the ventricular end of the main body toward the left ventricle and is bent back toward the atrial end.

17. The method of claim 8, wherein the main body comprises a spacer that does not allow blood to flow through the main body during diastole.

18. The method of claim 8, wherein the method further comprises delivering the prosthetic apparatus in a radially compressed state to the native mitral valve region via a transapical approach.

19. The method of claim 8, wherein the method further comprises delivering the prosthetic apparatus in a radially compressed state to the native mitral valve region via a transeptal approach.

20. The method of claim 8, wherein the atrial anchor comprises an atrial sealing member that blocks blood from flowing through space between the native valve leaflets and the main body in a direction toward left ventricle during diastole.

21. The method of claim 20, wherein the atrial sealing member also blocks blood from flowing through the space between the native valve leaflets and the main body in a direction toward the left atrium during systole.

22. The method of claim 8, wherein the atrial anchor extends radially outward from the main body a greater distance than the first and second ventricular anchors.

23. The method of claim 8, wherein allowing the main body to self-expand comprises allowing an atrial end portion of the main body to self-expand before allowing a ventricular end portion of the main body to self-expand.

24. The method of claim 8, wherein allowing the main body to self-expand comprises allowing a ventricular end portion of the main body to self-expand before allowing an atrial end portion of the main body to self-expand.

25. The method of claim 8, wherein prior to positioning the first and second ventricular anchors behind the native valve leaflets, the first and second ventricular anchors are expanded away from the main body while the main body is retained in a radially compressed state.

26. The method of claim 25, wherein expanding the first and second ventricular anchors away from the main body comprises moving an outer sheath proximally relative to an inner sheath such that the outer sheath uncovers the first and second ventricular anchors and the main body is retained in a radially compressed state within the inner sheath.

27. The method of claim 26, wherein allowing the main body to self-expand from the radially compressed state to an expanded state comprises moving the inner sheath proximally relative to the main body.

28. A method for implanting a prosthetic heart valve at the native mitral valve region of a heart, the native mitral valve having a native annulus, posterior and anterior native valve leaflets, and first and second commissures, the method comprising:

inserting a delivery apparatus through the apex of the heart in a direction toward the left atrium, the delivery apparatus containing the prosthetic heart valve in a radially compressed state, the prosthetic heart valve comprising a main body, a plurality of leaflets supported within the main body, an atrial anchor, and first and second ventricular anchors on diametrically opposite sides of the main body;

moving an outer sheath proximally relative to an inner sheath of the delivery apparatus such that the outer sheath uncovers the first and second ventricular anchors and then expanding the first and second ventricular anchors away from the main body while the main body and the atrial anchor are retained in a radially compressed state within the inner sheath;

positioning the main body within the native annulus, the first and second ventricular anchors behind the anterior and posterior native leaflets, respectively, and the atrial anchor within the left atrium; and

moving the inner sheath proximally relative to the main body and the atrial anchor to allow the atrial anchor to expand away from the main body in the left atrium and to allow the main body to radially expand and contact inner surfaces of the native valve leaflets.

29. The method of claim 28, wherein the act of positioning comprises aligning the first and second ventricular anchors with the A2 and P2 positions of the anterior and posterior native valve leaflets, respectively, and then advancing the delivery apparatus distally toward the left atrium to position the first and second ventricular anchors behind the A2 and P2 positions of the anterior and posterior native valve leaflets.

30. The method of claim 28, wherein the act of moving the inner sheath comprises moving the inner sheath proximally to uncover the atrial anchor and allow the atrial anchor to self-expand within the left atrium and then further moving the inner sheath proximally to uncover the main body and allow the main body to self-expand within the native valve annulus.

31. The method of claim 28, wherein portions of the anterior and posterior native valve leaflets are pressed against the main body by the first and second ventricular anchors after the main body is expanded.