Introducer sheath for prosthetic heart valve

Abstract

The present disclosure pertains to introducer sheaths with an inner liner for percutaneous insertion of a medical device into a patient. The introducer sheaths can further have a tubular layer and an outer layer. The tubular layer can be a metal sleeve having a plurality of slots. The present disclosure also discloses embodiments of catheter-based prosthetic heart valves, including, prosthetic heart valves having sealing members configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted.

What is claimed is: 
     
         1 . An introducer sheath for percutaneous insertion of a medical device into a patient, comprising:
 a tubular layer comprising an inner surface and an outer surface;   an inner liner covering the inner surface of the tubular layer;   an outer layer covering the outer surface of the tubular layer.   
     
     
         2 . The introducer sheath of  claim 1 , wherein the inner liner comprises nylon-12, polyethylene, or fluorinated ethylene propylene. 
     
     
         3 . The introducer sheath of  claim 1 , wherein the inner liner has a radial wall thickness in the range of from about 0.025 mm (about 0.001 inch) to about 0.075 mm (about 0.003 inch). 
     
     
         4 . The introducer sheath of  claim 1 , wherein the tubular layer has a radial wall thickness in the range of from about 0.05 mm (about 0.002 ) to 0.15 mm (about 0.006 inch). 
     
     
         5 . The introducer sheath of  claim 1 , wherein the outer liner has a radial wall thickness in the range of from about 0.025 mm (about 0.001 inch) to about 0.075 mm (about 0.003 inch). 
     
     
         6 . The introducer sheath of  claim 1 , wherein the inner liner, the tubular layer, and the outer layer together have a radial wall thickness in the range of from about 0.09 mm (about 0.0035 inch) to about 0.3 mm (about 0.012 inch). 
     
     
         7 . The introducer sheath of  claim 1 , wherein the tubular layer comprises a metal or metal alloy. 
     
     
         8 . The introducer sheath of  claim 1 , wherein the tubular layer comprises a plurality of circumferentially or helically extending slots. 
     
     
         9 . The introducer sheath of  claim 8 , wherein the inner liner does not extend radially outwardly through the plurality of slots in the tubular layer. 
     
     
         10 . The introducer sheath of  claim 8 , wherein the inner liner material extends radially outwardly into the plurality of slots in the tubular layer. 
     
     
         11 . The introducer sheath of  claim 1 , wherein the outer layer is secured to the outer surface of the tubular layer with an adhesive. 
     
     
         12 . The introducer sheath of  claim 1 , wherein the outer layer is secured to the outer surface of the tubular layer by thermal welding. 
     
     
         13 . The introducer sheath of  claim 1 , wherein the outer layer comprises nylon-12, a polyether block amide, polyethylene, or a combination thereof. 
     
     
         14 . The introducer sheath of  claim 8 , wherein the inner liner and the outer layer are bonded to each other through the plurality of slots of the tubular layer. 
     
     
         15 . The introducer sheath of  claim 1 , wherein the inner liner and the outer layer are bonded to the tubular layer at a proximal end of the tubular layer and at a distal end of the tubular layer. 
     
     
         16 . The introducer sheath of  claim 15 , wherein the inner liner and the outer layer are unattached to the tubular layer between the proximal end and the distal end. 
     
     
         17 . The introducer sheath of  claim 8 , wherein the plurality of slots comprise a plurality of circular bands or rings interconnected by two links or connecting portions extending between each pair of adjacent rings. 
     
     
         18 . The introducer sheath of  claim 17 , wherein each pair of links connecting two adjacent bands are spaced about 180 degrees from each other and are rotationally offset by about 90 degrees from an adjacent pair of links. 
     
     
         19 . The introducer sheath of  claim 17 , wherein the plurality of slots further comprise two cutouts or apertures formed in each circular band. 
     
     
         20 . The introducer sheath of  claim 19 , wherein the cutouts have a generally elliptical or oval shape. 
     
     
         21 . The introducer sheath of  claim 19 , wherein each cutout extends about 180 degrees in the circumferential direction of the tubular layer and is rotationally offset by about 90 degrees from the cutout in an adjacent circular band. 
     
     
         22 . The introducer sheath of  claim 1 , wherein the introducer sheath has a minimum bend radius without visual kink of about 2.5 cm (1″). 
     
     
         23 . The introducer sheath of  claim 22 , wherein the introducer sheath has an inner diameter of about 5.8 mm (about 0.229 inch). 
     
     
         24 . The introducer sheath of  claim 22 , wherein the introducer sheath has a minimum bend radius allowing passage of 16-Fr dilator of about 2.5 cm (1″).