Cross slit gasket for introducer sheath

Abstract

A sheath introducer system including a sheath introducer defining a lumen therethrough and having a proximal valve housing in fluid communication with a distal tubular sheath, wherein a proximal end of the valve housing defines a proximal opening of the lumen of the sheath introducer. A gasket seated within the valve housing has a first surface, a second surface and an outer periphery extending between the first and second surfaces. A first slit is formed into the first surface having an inner surface defining a first gap. A second slit formed into the second surface having an inner surface defining a second gap. A notch extends into the first gap of the first slit forming a bump on the inner surface of the first slit, wherein the second slit intersects the first slit at the notch such that the notch prevents the first and second slits from being in fluid communication.

1 - 14 . (canceled) 
     
     
         15 : A method of forming a gasket for a percutaneous catheter introducer comprising:
 molding the gasket to form a first surface, a second surface and an outer periphery extending between the first and second surfaces, wherein during molding a first slit is formed into the first surface having an inner surface defining a first gap and a second slit is formed into the second surface having an inner surface defining a second gap;   forming a notch that extends into the first dap of the first slit to create a bump on an inner surface of the first slit, wherein the second slit intersects the first slit at the notch such that the notch prevents the first and second slits from being in fluid communication;   seating the gasket within a valve housing of the percutaneous catheter introducer; and   compressing the gasket within the valve housing so as to close at least one of the first gap and the second cap gaps to form a seal.   
     
     
         16 : The method of  claim 15 , wherein the first slit is molded such that the inner surface of the first slit is defined by spaced apart opposing walls in an uncompressed configuration. 
     
     
         17 : The method of  claim 16 , wherein the spaced apart walls converge at a rounded surface, the rounded surface extending along a longitudinal length of the first slit. 
     
     
         18 . (canceled) 
     
     
         19 : The method according to  claim 15 , wherein the notch has a first dimension extending along a length of the first slit, and wherein the notch has a second dimension which has a maximum width substantially equal to a width of the first slit. 
     
     
         20 : The method according to  claim 19 , wherein the first dimension of the notch has sufficient length to prevent the second slit from establishing fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
     
     
         21 : The method according to  claim 19 , wherein the second dimension of the notch has sufficient width to prevent the second slit from establishing fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
     
     
         22 : The method according to  claim 15  further comprising:
 piercing the notch to establish fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
 
     
     
         23 : The method according to  claim 15 , wherein compressing the gasket within the valve housing includes applying a longitudinal force to the first surface of the gasket or applying a radial force to the outer periphery of the gasket. 
     
     
         24 : A method of forming a gasket for use in a percutaneous catheter introducer comprising:
 molding the gasket to form a first surface, a second surface and an outer periphery extending between the first and second surfaces, wherein during molding a first slit is formed into the first surface having an inner surface defining a first gap and a second slit is formed into the second surface having an inner surface defining a second gap; and   forming a notch extending into the first gap of the first slit, the notch thereby creating a raised bump on an inner surface of the first slit, wherein the second slit intersects the first slit at the notch such that the notch prevents the first slit and the second slit from being in fluid communication.   
     
     
         25 : The method according to  claim 24 , further comprising:
 seating the gasket within a valve housing of the percutaneous catheter introducer; and   compressing the gasket within the valve housing so as to close at least one of the first gap and the second gap to form a seal.   
     
     
         26 : The method according to  claim 24 , wherein the first slit is molded such that the inner surface of the first slit is defined by spaced apart opposing walls in an uncompressed configuration. 
     
     
         27 : The method according to  claim 26 , wherein the spaced apart opposing walls converge at a rounded surface, the rounded surface extending along a longitudinal length of the first slit, 
     
     
         28 : The method according to  claim 24 , wherein the notch has a first dimension extending along a length of the first slit, and wherein the notch has a second dimension which has a maximum width substantially equal to a width of the first slit. 
     
     
         29 : The method according to  claim 28 , wherein the first dimension of the notch has sufficient length to prevent the second slit from establishing fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
     
     
         30 : The method according to  claim 28 , wherein the second dimension of the notch has sufficient width to prevent the second slit from establishing fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
     
     
         31 : The method according to  claim 24  further comprising:
 piercing the notch to establish fluid communication between the first gap and the second gap of the first slit and the second slit, respectively. 
 
     
     
         32 : The method according to  claim 24 , wherein the notch is formed during molding of the gasket. 
     
     
         33 : A method of assembling a gasket into a percutaneous catheter introducer comprising:
 forming the gasket with a first surface, a second surface and an outer periphery extending between the first and second surfaces, wherein the gasket includes a first slit formed into the first surface having an inner surface defining a first gap and a second slit formed into the second surface having an inner surface defining a second gap;   forming a notch that extends into the first gap of the first slit to create a bump on an inner surface of the first slit, wherein the second slit intersects the first slit at the notch such that the notch prevents the first slit and the second slit from being in fluid communication;   seating the gasket within a valve housing of the percutaneous catheter introducer; and   compressing the gasket within the valve housing so as to close at least one of the first gap and the second gap to form a seal.   
     
     
         34 : The method of  claim 33 , wherein the gasket is formed by molding and the first slit the second slit, and the notch are formed during molding of the gasket. 
     
     
         35 : The method of  claim 33 , wherein the first slit and the second slit are formed by cutting.