Prosthetic valve for replacing mitral valve

• US 8,449,599 B2
• Filed: 12/02/2010
• Issued: 05/28/2013
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chau, Mark, Patterson, Marlowe, Yi, Seung, Geist, Steve, Oba, Travis
• Primary Examiner(s): Sweet, Thomas
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/959,292
• Publication Number:
  US 20110137397A1
• Time in Patent Office: 908 Days
• Field of Search: 623 21- 219, 623 124- 126
• US Class Current: 623/1.26
• 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 prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described.

Claims

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

a main body comprising a lumen and configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state;

at least one anchor coupled to and disposed outside of the main body, the anchor being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the anchor and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the anchor, the space decreases to capture the leaflet between the outer surface of the main body and the anchor; and

an annular flange portion extending radially outward from an atrial end of the main body, the annular flange portion comprising an atrial sealing member that blocks blood from flowing beyond the atrial end of the main body outside of the main body when the prosthetic apparatus is implanted.

2. The prosthetic apparatus of claim 1, wherein the atrial sealing member is substantially frustoconical and extends from the atrial end of the main body radially outward and toward the ventricular end of the main body.

3. The prosthetic apparatus of claim 1, wherein the anchor comprises a base portion that is secured to the main body adjacent a ventricular end of the main body, the anchor further comprising a free end portion opposite the base portion that extends toward the annular flange portion, the free end portion of the anchor being spaced from the annular flange portion such that the native valve leaflet extends between the free end portion and the annular flange portion when the native valve leaflet is in the leaflet-receiving space.

4. The prosthetic apparatus of claim 1, wherein the at least one anchor comprises a plurality of anchors that are spaced around the outside of the main body, and wherein the plurality of anchors comprises an anterior anchor and a posterior anchor coupled to the main body at about diametrically opposed locations on the main body, the anterior anchor defining a first leaflet-receiving space for capturing the native anterior leaflet of a native mitral valve between the anterior anchor and the outer surface of the main body and the posterior anchor defining a second leaflet-receiving space for capturing the native posterior leaflet of the native mitral valve between the posterior anchor and the outer surface of the main body.

5. The prosthetic apparatus of claim 4, wherein the first leaflet-receiving space is configured to capture an intermediate portion of the anterior leaflet between a postero-medial margin of the anterior leaflet and an antero-lateral margin of the anterior leaflet, and wherein the second leaflet-receiving space is configured to capture an intermediate portion of the posterior leaflet between a postero-medial margin of the posterior leaflet and an antero-lateral margin of the posterior leaflet, such that when the prosthetic apparatus is implanted in the native mitral valve:

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 antero-lateral margins and postero-lateral margins of the native leaflets 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 native valve leaflets 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.

6. The prosthetic apparatus of claim 1, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

7. The prosthetic apparatus of claim 1, wherein the anchor is coupled to the main body such that in the absence of any radial inward forces on the anchor, a free end of the anchor can remain substantially stationary as the main body is radially compressed or expanded.

8. The prosthetic apparatus of claim 1, wherein the leaflet-receiving space is configured to capture an intermediate portion of the native valve leaflet between a postero-medial margin of the leaflet and an antero-lateral margin of the leaflet, such that when the prosthetic apparatus is implanted in the native mitral valve:

during diastole, blood in the left atrium is allowed to flow toward the left ventricle between the outer surface of the main body and the native valve leaflets; and

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

9. The prosthetic apparatus of claim 1, wherein the at least one anchor is coupled to an anchor attachment portion of the main body, and wherein the at least one anchor is configured to self-expand to a radially extended state when released from a delivery sheath while the anchor attachment portion of the main body is retained in the radially compressed state by the delivery sheath.

10. The prosthetic apparatus of claim 9, wherein the at least one anchor is configured to self-expand to the radially extended state when released from a delivery sheath while the entire main body is retained in the radially compressed state by the delivery sheath.

11. The prosthetic apparatus of claim 1, wherein the anchor comprises a flexible elongate member having a first end portion attached to a first attachment portion of the main body and a second end portion, opposite the first end portion, attached to a second attachment portion of the main body, wherein the first and second attachment portions are adjacent to a ventricular end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a ventricular direction, wherein the elongate member further comprises an intermediate portion that extends from the first end portion and the second end portion and in an atrial direction lengthwise of the main body, and wherein the leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

12. The prosthetic apparatus of claim 11, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

13. A prosthetic apparatus for implantation within a native mitral valve of a heart, the native mitral valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a tubular main body comprising a lumen and configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state, the main body comprising an inflow end and an outflow end;

a plurality of anchors coupled to and disposed outside of the main body, the anchors positioned to define a plurality of leaflet-receiving spaces between the anchors and an outer surface of the main body for receiving native valve leaflets therebetween, wherein each anchor comprises a first portion that extends in a ventricular direction beyond the outflow end of the main body and a second portion that extends back toward the inflow end of the main body along a length of the main body; and

an annular flange portion extending radially outward from an atrial end of the main body, the annular flange portion comprising an atrial sealing member adapted to impede blood from flowing between the native mitral valve and the main body when the prosthetic apparatus is implanted.

14. The prosthetic apparatus of claim 13, wherein the first portion of each anchor is secured to the main body adjacent the outflow end of the main body, and the second portion of each anchor comprises a free end portion opposite the first portion that extends toward the annular flange portion, the free end portion of the anchor being spaced from the annular flange portion such that a corresponding native valve leaflet extends between the free end portion and the annular flange portion when the native valve leaflet is captured in the leaflet-receiving space.

15. The prosthetic apparatus of claim 13, wherein the plurality of anchors comprises an anterior anchor and a posterior anchor coupled to the main body at about diametrically opposed locations on the main body, the anterior anchor defining a first leaflet-receiving space for capturing the native anterior leaflet of a native mitral valve between the anterior anchor and the outer surface of the main body and the posterior anchor defining a second leaflet-receiving space for capturing the native posterior leaflet of the native mitral valve between the posterior anchor and the outer surface of the main body.

16. The prosthetic apparatus of claim 15, wherein the first leaflet-receiving space is configured to capture an intermediate portion of the anterior leaflet between a postero-medial margin of the anterior leaflet and an antero-lateral margin of the anterior leaflet, and wherein the second leaflet-receiving space is configured to capture an intermediate portion of the posterior leaflet between a postero-medial margin of the posterior leaflet and an antero-lateral margin of the posterior leaflet, such that when the prosthetic apparatus is implanted in the native mitral valve:

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 antero-lateral margins and postero-lateral margins of the native leaflets 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 native valve leaflets 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.

17. The prosthetic apparatus of claim 13, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

18. The prosthetic apparatus of claim 13, wherein at least one of the leaflet-receiving spaces is configured to capture an intermediate portion of the native valve leaflet between a postero-medial margin of the leaflet and an antero-lateral margin of the leaflet, such that when the prosthetic apparatus is implanted in the native mitral valve:

during diastole, blood in the left atrium is allowed to flow toward the left ventricle between the outer surface of the main body and the native valve leaflets; and

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

19. The prosthetic apparatus of claim 13, wherein each anchor comprises a flexible elongate member, wherein said first portion of the anchor comprises first and second end portions of the elongate member, the first end portion being attached to a first attachment portion of the main body and the second end portion being attached to a second attachment portion of the main body, wherein the first and second attachment portions are at the outflow end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a ventricular direction beyond the outflow end of the main body, wherein said second portion of the anchor comprises an intermediate portion of the elongate member that extends from the first end portion and the second end portion and in an atrial direction lengthwise of the main body, and wherein a respective leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

20. The prosthetic apparatus of claim 19, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

21. The prosthetic valve of claim 13, wherein the anchors are configured to compress portions of the native leaflets between the anchors and the main body.