Longitudinally reinforced sheath

Abstract

A sheath for deploying a medical device to a target site in the body of a patient. A tubular inner liner has a proximal portion, a distal portion, and an outer surface. An outer jacket has a proximal portion, a distal portion, and an inner surface. A reinforcing member is received within a length of the outer jacket. The outer jacket is positioned longitudinally around the inner liner and bonded to the outer surface of the liner. The reinforcing member, which may be a triaxial braid, or an encapsulated longitudinal reinforcing wire, extends along the outer jacket length and is configured for inhibiting elongation of the sheath upon deployment of the device.

We claim: 
     
         1 . A sheath for deploying a medical device to a target site in the body of a patient, comprising:
 a tubular liner having a proximal portion, a distal portion, and an outer surface;   an outer jacket having a proximal portion, a distal portion, and an inner surface, said outer jacket positioned longitudinally around the liner such that the outer jacket inner surface is bonded to the outer surface of the liner; and   a reinforcing member received within a length of the outer jacket, said reinforcing member extending along said outer jacket length and having a length such that a proximal end of the reinforcing member extends proximal of a proximal end of said outer jacket, and wherein said reinforcing member is configured for inhibiting elongation of the sheath upon deployment of said device therefrom.   
     
     
         2 . The sheath of  claim 1 , wherein said reinforcing member comprises a longitudinal stiffening wire encapsulated along said length of the outer jacket. 
     
     
         3 . The sheath of  claim 2 , wherein the stiffening wire has a length such that a distal end of the stiffening wire does not extend to the distal end of said outer jacket. 
     
     
         4 . The sheath of  claim 1 , wherein the outer jacket comprises an extruded first polymer having a first stiffness, and the reinforcing member comprises a second polymer co-extruded along a length of the first polymer and encapsulated therein, the second polymer having a second stiffness greater than the first stiffness. 
     
     
         5 . The sheath of  claim 4 , further comprising at least one additional longitudinal reinforcing member co-extruded along said length of the first polymer and encapsulated therein, said at least one additional reinforcing member having a stiffness greater than said first stiffness. 
     
     
         6 . The sheath of  claim 5 , wherein each of the longitudinal reinforcing members are spaced equally along a circumference of said outer jacket length. 
     
     
         7 . The sheath of  claim 1 , wherein said reinforcing member extends between ninety percent and one hundred percent of a length of said tubular liner. 
     
     
         8 . The sheath of  claim 1 , wherein said inner liner comprises a lubricious fluoropolymer, and said outer jacket comprises a heat shrinkable polymer, said inner liner having a roughened outer surface wherein said outer jacket is bonded to said inner liner at said roughened outer surface. 
     
     
         9 . The sheath of  claim 1 , wherein the sheath has a flare at a proximal end and the longitudinal member extends beyond the flare. 
     
     
         10 . The sheath of  claim 1 , further comprising a self-expanding stent disposed within the inner liner. 
     
     
         11 . The sheath of  claim 10 , wherein the stent is greater than 100 millimeters. 
     
     
         12 . A method for forming an introducer sheath, comprising:
 positioning an inner liner over a mandrel;   positioning an outer jacket over the inner liner, the outer jacket having a longitudinal reinforcing member extending beyond an end of the outer jack and at least partially encapsulated along a length thereof; and   heating an assembly comprising said inner liner, reinforcing member, and outer jacket such that said outer jacket at least partially melts and bonds to an outer surface of the inner liner.   
     
     
         13 . The method of  claim 16 , wherein said outer jacket comprises a tubular member having a first, larger lumen and at least one second, smaller lumen extending along said outer jacket length, further comprising the steps of positioning the longitudinal reinforcing member in the at least one second lumen, and maintaining a tension on the reinforcing member. 
     
     
         14 . The method of claim  17 , further comprising the step of maintaining said tension on the reinforcing member by capturing a distal end of the longitudinal reinforcing member in a melted distal portion of the outer jacket prior to heating said assembly. 
     
     
         15 . The method of  claim 16 , wherein the outer jacket having the longitudinal reinforcing member at least partially encapsulated along a length thereof is formed by co-extruding said jacket and said longitudinal reinforcing member, the extruded jacket having a first stiffness, and the extruded longitudinal reinforcing member having a second stiffness, the second stiffness being greater than the first stiffness. 
     
     
         16 . The method of claim  19 , wherein said outer jacket further comprises at least one additional longitudinal reinforcing member co-extruded along said jacket length and at least partially encapsulated therein.