DEVICES, SYSTEMS, AND METHODS FOR A VALVE REPLACEMENT
Disclosed are valve replacement devices, systems, and methods. Valve replacement devices may comprise one-or two-piece systems comprising a receiver body (also called an adapter) and a valve assembly with replacement leaflets attached to and located within the receiver body. In two-piece systems, the valve assembly may be removable from the receiver body such that both can be delivered together or separately, and the receiver body may remain implanted while the valve assembly may be removed and replaced. Also described are devices, systems, and methods related to delivering, removing, and replacing a valve replacement. Such delivery methods may include transseptal insertion of a new minimum leaflet structure, and securement of the valve replacement using several securement type (e.g., supra-annular, sub-annular, radial, leaflet securement, etc.). Also described is a braided helical design that mimics the heart's natural movement, and a flange structure for assisting the functioning of the valve replacement.
1 . A prosthetic valve, comprising:
a tubular body comprising a first braided wire, an inflow end and an outflow end;
a flange comprising a second braided wire woven into the first braided wire of the tubular body, the flange comprising a portion extending radially outwardly from the tubular body in a direction towards the inflow end, and the flange comprising a curved section and a D-shaped perimeter;
at least one stabilizer extending from the tubular body near the outflow end; and
at least one leaflet clip extending from the tubular body near the outflow end.
2 . The prosthetic valve of claim 1 , wherein the tubular body comprises an intermediate portion between the inflow end and the outflow end, and wherein the flange's curved section extends from the intermediate portion.
3 . The prosthetic valve of claim 2 , wherein at least a portion of the curved section is configured to rest in an intra-annular space of a native cardiac valve when the prosthetic valve is deployed across in the native cardiac valve.
4 . The prosthetic valve of claim 3 , wherein at least a portion of the curved section transitions into the D-shaped perimeter.
5 . The prosthetic valve of claim 1 , wherein the at least one leaflet clip comprises posterior and anterior leaflet clips inclined towards the inflow end of the tubular body.
6 . The prosthetic valve of claim 1 , wherein the at least one stabilizer comprises medial and lateral stabilizers inclined towards the inflow end of the tubular body.
7 . The prosthetic valve of claim 1 , wherein at least a portion of the flange is configured to rest in a supra-annular space of a native cardiac valve when the prosthetic valve is deployed across in the native cardiac valve.
8 . The prosthetic valve of claim 7 , wherein a first portion of the flange is configured to rest in an intra-annular space of a native cardiac valve when the prosthetic valve is deployed across in the native cardiac valve, and wherein a second portion of the flange is configured to rest in a supra-annular space of the native cardiac valve when the prosthetic valve is deployed across in the native cardiac valve.
9 . The prosthetic valve of claim 1 , wherein the second braided wire of the flange comprises peaks along the D-shaped perimeter of the flange, wherein the peaks of the flange comprise a petal shape near the inflow end of the tubular body.
10 . The prosthetic valve of claim 1 , further comprising prosthetic leaflets attached to the tubular body.
11 . The prosthetic valve of claim 10 , wherein the prosthetic leaflets comprise a commissure attached to the tubular body near the at least one leaflet clip.
12 . A prosthetic valve, comprising:
a receiver body comprising a first braided wire, an inflow end and an outflow end;
a flange comprising a second braided wire woven into the first braided wire of the receiver body, the flange comprising a portion extending radially outwardly from the receiver body towards the inflow end and the flange comprising a curved section and a D-shaped perimeter, wherein at least a portion of the flange's curved section is configured to rest in an intra-annular space of a native mitral annulus when deployed in a native valve.
13 . The prosthetic valve of claim 12 , wherein at least a portion of the flange's D-shaped perimeter is configured to rest against supra-annular tissue of the native annulus when deployed in the native valve.
14 . The prosthetic valve of claim 12 , further comprising an anterior leaflet clip extending anteriorly from the receiver body near the outflow end.
15 . The prosthetic valve of claim 14 , further comprising a posterior leaflet clip extending posteriorly from the receiver body near the outflow end.
16 . The prosthetic valve of claim 12 , further comprising a medial stabilizer extending medially from the receiver body near the outflow end.
17 . The prosthetic valve of claim 16 , further comprising a lateral stabilizer extending laterally from the receiver body near the outflow end.
18 . The prosthetic valve of claim 17 , wherein the medial and lateral stabilizers extend from the second braided wire of the flange.
19 . The prosthetic valve of claim 15 , wherein the anterior and posterior leaflet clips extend from the first braided wire of the receiver body.
20 . The prosthetic valve of claim 19 , wherein the anterior and posterior leaflets clips each comprise curved wires that exit and enter the receiver body at different locations along the first braided wire of the receiver body.
21 . The prosthetic valve of claim 18 , wherein the medial and lateral stabilizers each comprise curved wires that exit and enter the receiver body at different locations along the second braided wire of the flange.
22 . A prosthetic valve, comprising:
a tubular body comprising a first braided wire, an inflow end and an outflow end;
a flange comprising a second braided wire woven into the first braided wire of the tubular body, the flange comprising a portion extending radially outwardly from the tubular body and towards the inflow end of the tubular body;
at least one stabilizer extending from a lower portion of the tubular body at the outflow end, wherein the at least one stabilizer extends from the second braided wire of the flange and extends towards the inflow end of the tubular body;
at least one leaflet clip extending from the tubular body at the outflow end, wherein the at least one leaflet clip extends from the first braided wire of the tubular body and extends towards the inflow end of the tubular body.
23 . The prosthetic valve of claim 22 , wherein the at least one leaflet clip comprises a curved wire that exits the tubular body at a first location along a circumference of the tubular body and re-enters the tubular body at a second location along the circumference of the tubular body.
24 . The prosthetic mitral valve of claim 22 , wherein the at least one stabilizer comprises a curved wire that exits the tubular body at a first location along a circumference of the tubular body and re-enters the tubular body at a second location along the circumference of the tubular body.
25 . The prosthetic valve of claim 22 , wherein the flange comprises a curved section and a D-shaped perimeter, wherein at least a portion of the curved section is configured to rest in an intra-annular space of a native annulus when deployed in a native valve, and wherein at least a portion of the D-shaped perimeter is configured to rest on top of the native annulus when deployed in the native valve.
26 . A prosthetic valve, comprising:
a tubular body comprising a first braided wire, an inflow end, an outflow end, and a lower portion near the outflow end; and
a flange comprising a second braided wire woven into the first braided wire of the tubular body, the flange comprising a portion extending radially outwardly from the tubular body and extending in a direction away from the outflow end and beyond the inflow end;
at least one anchor extending from the lower portion of the tubular body;
wherein the tubular body is undersized in comparison to a native annulus of a native valve in one of more of an anterior-to-posterior (A-P) and commissure-to-commissure (C-C) directions, wherein the tubular body does not exert radial force against the native annulus in the undersized directions when deployed in the native valve.
27 . The prosthetic valve of claim 26 , wherein the at least one anchor comprises posterior and anterior leaflet clips.
28 . The prosthetic valve of claim 26 , further comprising at least one stabilizer extending from the lower portion of the tubular body.
29 . The prosthetic valve of claim 28 , wherein the at least one stabilizer comprises medial and lateral stabilizers.
30 . The prosthetic valve of claim 26 , wherein the tubular body is between 17 to millimeters in height and between 25 to 34 millimeters in width.