Fabric Material For Medical Devices

Abstract

At least a portion of fabrics for use in medical devices is formed from polymeric materials. The fabrics may be uncoated, partially coated or fully coated with one or more layers of a polymer. The fabrics may be used for the leaflets and/or cuffs of prosthetic heart valves and as a component of other medical devices.

1 . A replacement heart valve comprising:
 a self-expandable or balloon-expandable stent; and   a valve assembly sutured to the stent, the valve assembly comprising a cuff and a prosthetic leaflet composed of a coated or uncoated woven polymer fabric having at least one of: (i) an ultimate tensile strength between 25 MPa and 250 MPa; (ii) a tear strength of between 10 lbF and 40 lbF; (iii) a permeability of between 10 mLcm 2 /min—and 1,200 mLcm 2 /min; (iv) a suture retention of between 30 N and 70 N; (v) a stiffness/flexural rigidity of between 0.001 cm and 4 cm; and (vi) a stretch of between 3% and 50%,   wherein the prosthetic leaflet has a thickness of between about 5 μm and about 500 μm and the cuff has a thickness of between about 1 μm and about 300 μm.   
     
     
         2 . The replacement heart valve of  claim 1 , wherein the cuff or prosthetic leaflet further comprises:
 (i) a wire attached to a major surface of the woven polymer fabric or a coating layer on the woven polymer fabric;   (ii) a stitch through the woven polymer fabric, wherein the stitch does not attach the leaflet or the cuff to another structure;   (iii) a suture line through the woven polymer fabric, wherein the suture line does not attach the leaflet or the cuff to another structure;   (iv) an area of the woven polymer fabric having a greater weave density than other portions thereof; or   (v) a grommet through the woven polymer fabric.   
     
     
         3 . The replacement heart valve of  claim 1 , wherein the replacement heart valve is configured to replace or repair a native aortic valve. 
     
     
         4 . The replacement heart valve of  claim 1 , wherein the replacement heart valve is configured to replace or repair a native mitral valve. 
     
     
         5 . The replacement heart valve of  claim 4 , wherein the stent includes a first inner stent portion having a generally cylindrical shape and a second outer stent portion generally surrounding the first inner stent portion, the second outer stent portion attached to the first inner stent portion so that when the replacement heart valve is implanted into a native mitral valve annulus, the second outer stent portion engages the native mitral valve annulus and at least partially mechanically isolates the first inner stent portion from being deformed by the anatomy of the native mitral valve annulus or calcification of the native mitral valve such that the first inner stent portion retains its generally cylindrical shape, the valve assembly being substantially only attached to the first inner stent portion. 
     
     
         6 . The replacement heart valve of  claim 1 , wherein the cuff is disposed on a luminal surface of the stent. 
     
     
         7 . The replacement heart valve of  claim 1 , wherein the cuff is disposed on an abluminal surface of the stent. 
     
     
         8 . The replacement heart valve of  claim 1 , wherein the cuff is disposed on an abluminal surface of the stent and includes structure to reduce paravalavular leaks around the abluminal surface of the stent. 
     
     
         9 . The replacement heart valve of  claim 8 , wherein a second cuff portion is disposed on a luminal surface of the stent. 
     
     
         10 . The replacement heart valve of  claim 1 , wherein the woven polymer fabric includes a partial coating or layer on at least one major surface of the woven polymer fabric adjacent a free edge or an attachment edge of the prosthetic leaflet. 
     
     
         11 . The replacement heart valve of  claim 1 , wherein the prosthetic leaflet further comprises:
 (i) a wire attached to a major surface of the woven polymer fabric or a coating layer on the woven polymer fabric to impart or maintain a three-dimensional shape of the prosthetic leaflet;   (ii) an area of the woven polymer fabric having a greater weave density than other portions thereof, the area of greater weave density configured to impart or maintain a three-dimensional shape of the prosthetic leaflet; or   (iii) a suture line through the woven polymer fabric, wherein the suture line does not attach the leaflet to another structure and is configured to impart or maintain a three-dimensional shape of the prosthetic leaflet.   
     
     
         12 . The replacement heart valve of  claim 11 , wherein the wire, the area of greater weave density, or the suture line are discontinuous. 
     
     
         13 . The replacement heart valve of  claim 1 , wherein the prosthetic leaflet further comprises at least one pleat. 
     
     
         14 . The replacement heart valve of  claim 1 , wherein the cuff or the prosthetic leaflet is formed of a coated woven polymer, wherein the coating is either a plurality of laminated layers or partial layers. 
     
     
         15 . The replacement heart valve of  claim 1 , wherein the coated or uncoated woven polymer fabric forming the prosthetic leaflet further comprises a layer or coating that, when compared to the woven polymer fabric without the layer or coating: (i) adjusts surface roughness; (ii) alters prosthetic leaflet strength; (iii) provides added abrasion resistance; (iv) provides improved lubricity; (v) adds weight to bias the prosthetic leaflet to close; (vi) provides additional rigidity; (vii) promotes prosthetic leaflet folding; (viii) alters cell adhesion; (ix) controls cellular ingrowth; (x) improves resistance to thrombosis; or (xi) includes a therapeutic agent.