Device and System for Transcatheter Mitral Valve Replacement

Abstract

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 which comprises an expandable tubular stent having a cuff and an expandable internal leaflet assembly, wherein said cuff is comprised of wire covered with stabilized tissue or synthetic material, wherein said leaflet assembly is disposed within the stent and is comprised of stabilized tissue or synthetic material, wherein one or more tethers are attached to the prosthetic heart valve and wherein one of such tethers is attached to an epicardial tether securing device. 
     
     
         2 . The prosthetic heart valve of  claim 1 , wherein the prosthetic heart valve is elastic and is compressed into a delivery catheter for deployment within a patient, and whereby upon expelling the prosthetic heart valve from the delivery catheter, the valve expands to its functional shape. 
     
     
         3 . The prosthetic heart valve of  claim 1 , wherein the cuff wire comprises wire from one end of the stent, wherein the cuff wire is formed as a series of radially extending loops. 
     
     
         4 . The prosthetic heart valve of  claim 3 , wherein the stent and/or the radially extending loops of the cuff are made from nickel-titanium alloy or a similar superelastic metal and articulate to locally contour to the valve annulus. 
     
     
         5 . The prosthetic heart valve of  claim 4 , wherein one or more of the radially extending loops extend outwardly in various lengths. 
     
     
         6 . The prosthetic heart valve of  claim 1 , wherein the stent and cuff are formed from the same piece of superelastic metal. 
     
     
         7 . The prosthetic heart valve of  claim 6 , wherein the stent and cuff are laser cut with pre-determined shapes to facilitate collapsing into a catheter delivery system. 
     
     
         8 . The prosthetic heart valve of  claim 1 , wherein the stabilized tissue is derived from bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa. 
     
     
         9 . The prosthetic heart valve of  claim 1 , wherein the stabilized tissue is derived from 30 day old bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa. 
     
     
         10 . The prosthetic heart valve of  claim 1 , wherein the synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene. 
     
     
         11 . The prosthetic heart valve of  claim 1 , wherein the stabilized tissue or synthetic material is treated with anticoagulant. 
     
     
         12 . The prosthetic heart valve of  claim 1 , wherein the stabilized tissue or synthetic material is heparinized. 
     
     
         13 . The prosthetic heart valve of  claim 1 , wherein the angle of the cuff to the stent comprises a range of between about 60 and about 150 degrees. 
     
     
         14 . The prosthetic heart valve of  claim 1 , wherein the ratio of the relationship between the height of the expanded deployed stent (h) and the lateral distance that the cuff extends onto the cardiac tissue (l) ranges from about 1:10 to about 10:1. 
     
     
         15 . The prosthetic heart valve of  claim 1 , wherein the cuff extends laterally beyond the wall of the expanded tubular stent between about 8 and about 20 millimeters. 
     
     
         16 . The prosthetic heart valve of  claim 1 , wherein the epicardial securing device is a pledget, button or similar device located on the outer surface of the apical epicardium, to which one or more tethers are attached. 
     
     
         17 . The prosthetic heart valve of  claim 1 , wherein the tubular stent has a first end and a second end, wherein the cuff is connected to the tubular stent at the first end of the tubular stent, and the second end of the tubular stent has a plurality of tether attachment structures. 
     
     
         18 . The prosthetic heart valve of  claim 1 , further comprising a plurality of tethers attached to the prosthetic heart valve for anchoring the prosthetic heart valve to native tissue. 
     
     
         19 . The prosthetic heart valve of  claim 18 , wherein at least one of the plurality of tethers is an elastic tether. 
     
     
         20 . The prosthetic heart valve of  claim 18 , wherein at least one of the plurality of tethers is a bioresorbable tether. 
     
     
         21 . The prosthetic heart valve of  claim 18 , wherein at least one of the plurality of tethers is a positioning tether and at least one of the plurality of tethers is an anchoring tether. 
     
     
         22 . The prosthetic heart valve of  claim 1 , wherein the cuff is connected to a plurality of tethers. 
     
     
         23 . The prosthetic heart valve of  claim 22 , wherein at least one of the plurality of tethers is an elastic tether. 
     
     
         24 . The prosthetic heart valve of  claim 22 , wherein at least one of the plurality of tethers is a bioresorbable tether. 
     
     
         25 . The prosthetic heart valve of  claim 22 , wherein at least one of the plurality of tethers is a positioning tether and at least one of the plurality of tethers is an anchoring tether. 
     
     
         26 . The prosthetic heart valve of  claim 1 , further comprising at least one tether attached to the cuff and/or at least one tether attached to the stent body. 
     
     
         27 . The prosthetic heart valve of  claim 26 , wherein at least one of the plurality of tethers is an elastic tether. 
     
     
         28 . The prosthetic heart valve of  claim 26 , wherein at least one of the plurality of tethers is a bioresorbable tether. 
     
     
         29 . The prosthetic heart valve of  claim 26 , wherein at least one of the plurality of tethers is a positioning tether and at least one of the plurality of tethers is an anchoring tether. 
     
     
         30 . The prosthetic heart valve of  claim 29 , wherein at least one of the plurality of tethers is an elastic tether. 
     
     
         31 . The prosthetic heart valve of  claim 29 , wherein at least one of the plurality of tethers is a bioresorbable tether. 
     
     
         32 . The prosthetic heart valve of  claim 1 , further comprising a plurality of anchoring barbs attached to the prosthetic heart valve for anchoring the valve into local tissue. 
     
     
         33 . The prosthetic heart valve of  claim 1 , wherein the leaflet assembly is constructed solely of stabilized tissue or synthetic material without a separate wire support structure, wherein the leaflet assembly comprises a plurality of valve leaflets attached to a leaflet housing, wherein the leaflet assembly is disposed within the lumen of the stent and is attached to the stent to provide a sealed joint between the leaflet assembly and the inner wall of the stent. 
     
     
         34 . The prosthetic heart valve of  claim 1 , wherein the leaflet assembly comprises a leaflet wire support structure to which a plurality of valve leaflets are attached and the entire leaflet assembly is housed within the stent body, wherein the leaflets are made from stabilized tissue or synthetic material, wherein the leaflet wire support is made from a superelastic metal, and wherein the leaflet assembly is disposed within the lumen of the stent and is attached to the stent to provide a sealed joint between the leaflet assembly and the inner wall of the stent. 
     
     
         35 . The leaflet assembly according to  claim 33 , wherein the leaflet assembly is shaped to have a hyperbolic paraboloid shape defining commissural points. 
     
     
         36 . A cuff for a prosthetic heart valve wherein the cuff has an articulating structure made of a superelastic metal that is covered with stabilized tissue or synthetic material. 
     
     
         37 . The cuff of  claim 36 , wherein the articulating structure comprises a plurality of radially extending loops. 
     
     
         38 . The cuff of  claim 37 , wherein the radially extending loops extend outwardly in various lengths. 
     
     
         39 . The cuff of  claim 36 , wherein the superelastic metal is a nickel-titanium alloy. 
     
     
         40 . The cuff of  claim 36 , wherein the stabilized tissue is derived from bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa. 
     
     
         41 . The cuff of  claim 36 , wherein the stabilized tissue is derived from 30 day old bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa. 
     
     
         42 . The cuff of  claim 36 , wherein the synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene. 
     
     
         43 . The cuff of  claim 36 , wherein the stabilized tissue or synthetic material is treated with anticoagulant. 
     
     
         44 . The cuff of  claim 36 , wherein the stabilized tissue or synthetic material is heparinized.