PROSTHETIC VALVE FOR REPLACING MITRAL VALVE

• US 20150202044A1
• Filed: 08/27/2014
• Published: 07/23/2015
• Est. Priority Date: 12/04/2009
• Status: Abandoned Application

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated), Edwards Lifesciences Corporation
• Original Assignee: Georg Lutter, Lucian Lozonschi, Mark Chau, Marlowe Patterson, Steve Geist, Travis Oba, Yi Seung
• Inventors: LOZONSCHI, Lucian, LUTTER, Georg, CHAU, Mark, PATTERSON, Marlowe, YI, Seung, OBA, Travis, GEIST, Steve
• Application Number:
  US14/470,621
• Publication Number:
  US 20150202044A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

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.

2. 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, and wherein the first and second attachment portions are adjacent to a ventricular end of the main body, and the elongate member further comprises an intermediate portion that extends from the first end portion to the second end portion and in a 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.

3. The prosthetic apparatus of claim 2, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

4. The prosthetic apparatus of claim 1, further comprising 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 on the outside of the main body when the prosthetic apparatus is implanted.

5. The prosthetic apparatus of claim 4, wherein the atrial sealing member is frustoconical and extends from the first end of the main body radially outward and toward the ventricular end of the main body.

6. The prosthetic apparatus of claim 4, wherein the anchor comprises a base 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, the free end portion 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.

7. 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.

8. 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.

9. 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, the anchor can remain substantially stationary as the main body is radially compressed or expanded.

10. 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 leaflets comprising a free edge portion and an annulus connection portion, the prosthetic apparatus comprising:

a main body configured for placement within the native mitral valve, the main body being compressible to a compressed state for delivery into the heart and expandable from the compressed state to an expanded state;

at least one ventricular anchor coupled to and disposed outside of the main body such that, in the expanded state, a leaflet-receiving space exists between the ventricular anchor and an outer surface of the main body to receive a free edge portion of a native valve leaflet, the ventricular anchor comprising an engagement portion configured to extend behind the received native leaflet and engage a ventricular surface of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the ventricular surface of the native annulus and the annulus connection portion of the received native leaflet, while the free edge portion of the received native leaflet is not engaged by the ventricular anchor; and

at least one atrial anchor coupled to and disposed outside of the main body, the at least one atrial anchor being configured to engage an atrial portion of the native mitral annulus, the annulus connection portion of the received native leaflet, or both the atrial surface of the native annulus and the annulus connection portion of the received native leaflet, at a location opposite the engagement portion of the ventricular anchor for retention of the prosthetic apparatus.

11. The prosthetic apparatus of claim 10, further comprising a valve portion coupled within the main body, the valve portion comprising valve leaflets that form a one-way valve within the main body.

12. The prosthetic apparatus of claim 10, wherein the ventricular anchor is configured to extend behind native chordae tendinae such that the engagement portion contacts the ventricular surface of the native mitral annulus at a commissure region between the native leaflets.

13. The prosthetic apparatus of claim 12, further comprising a second, diametrically opposed ventricular anchor having a second engagement portion, the ventricular anchors being configured such that the prosthetic apparatus can be rotated about a longitudinal axis to position the engagement portions of the anchors at opposing commissure regions of the native mitral annulus.

14. The prosthetic apparatus of claim 12, further comprising a second ventricular anchor having a second engagement portion, the anchors being positioned adjacent to one another on the same side of the prosthetic apparatus, the ventricular anchors being deflectable to a constrained position wherein the anchors overlap one another and the ventricular anchors being releasable from the constrained position such that the anchors resiliently move apart and the engagement portions of the anchors move in opposite directions to opposite commissure regions of the native mitral annulus.

15. A device for delivering a prosthetic apparatus to the mitral valve region of the heart, comprising:

an inner sheath comprising a distal end portion having at least one longitudinal slot extending proximally from a distal end of the inner sheath, the distal end portion of the inner sheath being configured to contain the prosthetic apparatus within the inner sheath in a radially compressed state; and

an outer sheath positioned concentrically around the inner sheath, wherein at least one of the inner sheath and the outer sheath is movable axially relative to the other between a first position, in which the outer sheath extends over at least a portion of the longitudinal slot, and a second position, in which the at least a portion of the longitudinal slot is uncovered by the outer sheath so as to allow a portion of the prosthetic apparatus contained within the inner sheath to expand radially outward through the longitudinal slot.

16. The device of claim 15 in combination with the prosthetic apparatus, wherein the prosthetic apparatus comprises a prosthetic valve comprising a frame and a fluid-occluding portion mounted to the frame, the frame comprising a main body configured to be implanted within a native heart valve annulus and at least one anchor coupled to the main body and being radially expandable relative to the main body through the slot in the inner sheath when the inner sheath and the outer sheath are in the second position.

17. The device of claim 15, further comprising a pusher shaft positioned within the inner sheath, wherein at least one of the pusher shaft and the inner sheath is movable axially relative to the other, the pusher shaft comprising a distal end configured to contact a proximal end of the prosthetic apparatus and urge the prosthetic apparatus out of the distal end of the inner sheath when there is relative movement between the pusher shaft and the inner sheath.

18. The device of claim 15, further comprising a retaining band positioned around the distal end portion of the inner sheath and extending over the slot, the retaining band being made of a frangible material that can break as a result of the expanded portion of the prosthetic apparatus being pushed through the retaining band as the prosthetic apparatus is advanced from the distal end of the inner sheath.

19. The device of claim 15, wherein the at least one longitudinal slot comprises a plurality of longitudinal slots and wherein each longitudinal slot is located at a diametrically opposed location from another longitudinal slot with respect to a central longitudinal axis of the inner sheath.

20. The device of claim 15, further comprising:

an inner shaft positioned within the inner sheath and being movable longitudinally relative to the inner sheath, the inner shaft being configured to be positioned within a lumen of the prosthetic apparatus when the prosthetic apparatus is contained within the inner sheath;

a housing;

a lead screw disposed in the housing and coupled to a proximal end portion of the inner sheath; and

a rotatable portion rotatably coupled to the lead screw such that rotation of the rotatable portion relative to the housing causes the lead screw and the inner sheath to move axially relative to the rotatable portion and the housing.