Systems and methods for mitral valve replacement
View Patent ↗Systems and methods of atrioventricular valve replacement are provided. In various embodiments, an arch-like support structure is provided that is insertable and implantable into a heart and is positioned in the mitral annulus to replace a native mitral valve. The support structure is operable to support, and various systems comprise leaflet and chord structures operable to control and regular blood flow between chambers of the heart.
1 . An atrioventricular valve replacement member comprising:
a structural support member comprising an arcuate support member extending at a non-orthogonal angle from an annular base member;
the arcuate support member comprising a first end and a second end, and wherein the first end and the second end are secured to the annular base member and wherein at least one of the arcuate support member and the annular base member are operable to be secured to human tissue; and
wherein at the non-orthogonal angle comprises an angle relative to the base member to direct blood flow at an angle relative to at least the annular base member; and
wherein the arcuate support member comprises at least one attachment portion for receiving and supporting at least one prosthetic chordal element.
2 . The replacement member of claim 1 , wherein the arcuate support member comprises a deformable metallic member.
3 . The replacement member of claim 1 , wherein a prosthetic leaflet structure is secured to the at least one attachment portion.
4 . The replacement member of claim 1 , wherein the replacement member comprises at least one strain-relief element to enable flexure of the arcuate support member and to enable the arcuate support member to deform between a first position and a second position.
5 . The replacement member of claim 4 , wherein the strain-relief element comprises at least one of a hinge, a bend or a loop provided in the arcuate support member and wherein a prosthetic chordal element is attached to the strain-relief element.
6 . The replacement member of claim 1 , wherein the replacement member comprises two arcuate support members.
7 . The replacement member of claim 1 , wherein the first end and the second of the arcuate support are secured to the annular base member and the base member comprises an annular fixation element operable to be anchored to tissue.
8 . The replacement member of claim 1 , wherein the non-orthogonal angle comprises and angle between 10 and 70 degrees.
9 . An atrioventricular valve implant comprising:
a support member that is deformable between a first position and a second position, wherein the first position comprises a compressed position operable for insertion into the human heart and wherein the second position comprises an expanded position operable for implantation;
the support member extending between a first end and a second end, and at least one of the first end and the second are operable to be secured to an annular base member, and wherein the support member comprises an attachment portion further operable to provide a strain-relief feature for the support member;
a flexible leaflet member secured to the attachment portion;
the leaflet member being operable to regulate blood flow through the implant and function as a one-way valve.
10 . The valve implant of claim 9 , wherein the leaflet member comprises a thickness of not more than 2.0 millimeters.
11 . The mitral valve implant of claim 9 , wherein a plurality of fenestrations are provided to form a fenestrated section and the open fenestrated areas comprise a majority of the fenestrated section.
12 . The valve implant of claim 9 , wherein primary neochordal and secondary neochordal leaflet extensions are provided, and wherein the secondary neochordal leaflet extensions extend in a different direction from the primary neochordal extensions and prevent tangling.
13 . The valve implant of claim 9 , wherein the arcuate support is operable to be provided at an angle relative to at least one of a plane in which the annular base member resides and an annular plane of a flow path of a mitral valve of the heart.
14 . The valve implant of claim 9 , wherein the leaflet member comprises at least one fenestration forming a neochordal leaflet extension operable to be secured to the support member.
15 . A method of forming a flexible biomimetic valve leaflet, the method comprising:
providing a bioprosthetic material;
providing a structural support member comprising an arcuate support member extending at a non-orthogonal angle from an annular base member and wherein the arcuate support member comprises a first end and a second end, and wherein the first end and the second end are secured to the annular base member and wherein at least one of the arcuate support member and the annular base member are operable to be secured to human tissue;
stretching the bioprosthetic material to achieve a desired biomimetic structure relative to the structural support member, and securing the bioprosthetic material to the arcuate support member; and
performing a cross-linking chemical fixation step.
16 . The method of claim 15 , wherein the bioprosthetic material comprises at least one of bovine, equine, or porcine pericardium.
17 . The method of claim 15 , wherein the step of stretching is performed on a curved jig.
18 . The method of claim 15 , wherein the step of stretching is performing before and during cross-linking chemical fixation.
19 . The method of claim 15 , wherein the cross-linking chemical fixation step is performed using at least one of glutaraldehyde, epoxides, and adjunctive anti-calcification strategies.
20 . A method of implanting a frame member for an atrioventricular valve implant, the method comprising:
providing a frame member with a support member and an annular base member, the frame member being deformable between a first position and a second position, wherein the first position comprises a compressed position operable for insertion into the human heart and wherein the second position comprises an expanded position operable for implantation;
applying a force to deform the support member to the first position;
inserting the frame member into a mitral annulus of a heart;
removing the force and allowing the support member to expand to the second position;
securing the frame member to native tissue; and
wherein the frame member is secured such that the support member is angled provided at a non-orthogonal angle relative to the annular base member to direct blood flow toward a posterior position.