Device and system for transcatheter mitral valve replacement
This invention relates to the design and function of a compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.
1 . A prosthetic heart valve having a compressed delivery configuration and an expanded deployed configuration, the prosthetic heart valve comprising:
a self-expanding outer stent having a tubular body and an atrial cuff integral with and flaring away from the tubular body, a cuff covering being disposed on at least one of a distal-facing side and a proximal facing side of the atrial cuff;
a collapsible and expandable inner leaflet support member disposed within a lumen of the tubular body and attached to the outer stent so that the inner leaflet support member is positioned radially inward of the outer stent in both the compressed delivery configuration and in the expanded deployed configuration, the inner leaflet support member forming three commissural tips that extend beyond an outflow end of the outer stent;
a prosthetic leaflet structure attached to the inner leaflet support member such that the prosthetic leaflet structure is positioned radially inward of the outer stent in both the compressed delivery configuration and in the expanded deployed configuration; and
an anchoring system including at least two wires extending from a ventricular end of the tubular body, the anchoring system not being directly attached to the prosthetic leaflet structure,
wherein in the compressed delivery configuration of the prosthetic heart valve, the prosthetic heart valve is configured to be received within a delivery catheter so that the tubular body is positioned between the atrial cuff and the anchoring system,
wherein, in a fully implanted condition of the prosthetic heart valve, the outer stent is shaped to contact inwardly facing surfaces of native leaflets of a native heart valve while the anchoring system anchors to a wall of a ventricle.
2 . The prosthetic heart valve of claim 1 , wherein the atrial cuff includes a plurality of radially extending loops collectively defining a collar shape and defining circumferential spaces between adjacent loops, the cuff covering being configured to permit the loops to articulate independently to conform to contours of an annulus of a native mitral or tricuspid valve.
3 . The prosthetic heart valve of claim 2 , wherein the loops have different lengths, defining an elongated collar.
4 . The prosthetic heart valve of claim 2 , wherein the cuff covering covers both the distal-facing side and the proximal-facing side of the atrial cuff and the radially outer ends of the loops.
5 . The prosthetic heart valve of claim 2 , wherein the cuff covering covers both the distal-facing side and the proximal-facing side of the atrial cuff and defines a peripheral edge of the atrial cuff that is spaced radially outwardly from the radially outer ends of the loops.
6 . The prosthetic heart valve of claim 1 , wherein the cuff covering is formed at least in part of a biocompatible synthetic material.
7 . The prosthetic heart valve of claim 1 , wherein the outer stent is formed of a nickel-titanium alloy.
8 . The prosthetic heart valve of claim 7 , wherein the inner leaflet support member is formed of a nickel-titanium alloy.
9 . The prosthetic heart valve of claim 1 , wherein the prosthetic heart valve is configured to replace a native mitral valve, and in the fully implanted condition of the prosthetic heart valve, the atrial cuff is configured to resist displacement of the prosthetic heart valve into the ventricle, the ventricle being a left ventricle.
10 . The prosthetic heart valve of claim 9 , wherein in the fully implanted condition of the prosthetic heart valve, the anchoring system is configured to resist displacement of the prosthetic heart valve into a left atrium.
11 . The prosthetic heart valve of claim 1 , wherein the atrial cuff covering is formed of cross-linked stabilized tissue, and the stabilized tissue is treated with anticoagulant.
12 . The prosthetic heart valve of claim 1 , wherein the cuff covering is formed of cross-linked stabilized tissue, and the stabilized tissue is heparinized.
13 . The prosthetic heart valve of claim 1 , wherein cuff covering is formed of cross-linked stabilized tissue, and the stabilized tissue has a thickness ranging from about 0.0762 mm and 0.254 mm.
14 . The prosthetic heart valve of claim 1 , wherein the prosthetic leaflet structure is formed of bovine pericardium.
15 . The prosthetic heart valve of claim 1 , wherein the atrial cuff forms an angle with respect to the tubular body in a range of between about 60 degrees and about 150 degrees when deployed.
16 . The prosthetic heart valve of claim 1 , wherein the three commissural tips can move independently of the outer stent.
17 . The prosthetic heart valve of claim 16 , wherein the three commissural are tips not directly coupled to the outer stent.
18 . The prosthetic heart valve of claim 17 , wherein the three commissural tips are capable of flexing inwardly or outwardly relative to the outer stent in the fully implanted condition of the prosthetic heart valve to relieve mechanical stresses on the prosthetic leaflet structure.
19 . The prosthetic heart valve of claim 18 , wherein the inner leaflet support member includes a portion which is directly coupled to the outer stent and which is spaced from the three commissural tips.
20 . The prosthetic heart valve of claim 1 , wherein the inner leaflet support member is a continuous and generally tubular wireform structure.
21 . The prosthetic heart valve of claim 1 , wherein the wall of the ventricle is a ventricular septum.