Valved Introducer Assembly and Method Therefor

Abstract

An introducer assembly includes a sheath having a sheath proximal end and distal end, and a passage therethrough. The introducer assembly further includes a valve assembly that is sealingly associated with the passage of the sheath. The valve assembly includes a valve having a first seal and a second seal, where the first and second seal optionally have different sealing properties. For example, the first seal and the second seal have different thicknesses, different sealing durometers, or otherwise different sealing features. In another option, the sheath is removable from the instrument disposed therethrough. In yet another option, the valve of the valve assembly further includes a chamber disposed between the first and second seals. The seals are spaced to accommodate devices with multiple flow holes therein.

1 . A method comprising:
 a) disposing an instrument through an introducer, the introducer having a sheath extending from a sheath proximal end to a sheath distal end, the sheath having a passage therethrough, the introducer having a valve assembly sealingly associated with the passage;   b) sealing a valve of the valve assembly against the instrument, the valve including a first seal, a second seal, and a chamber disposed between the first and second seals;   c) disposing the instrument includes disposing the instrument through at least the first seal, the chamber, and the second seal; and   d) separating the valve assembly and the introducer from around a cross-sectional perimeter of the instrument.   
     
     
         2 . The method as recited in  claim 1  wherein sealing the valve against the instrument includes sealing the first seal having one or more first properties and sealing the second seal having one or more second properties, where the first properties are different than the second properties. 
     
     
         3 . The method as recited in  claim 2  wherein sealing the first seal and the second seal includes sealing the first seal with a thinner seal than the second seal. 
     
     
         4 . The method as recited in  claim 2  wherein sealing the first seal and the second seal includes sealing the first seal with a greater durometer material than the second seal. 
     
     
         5 . The method as recited in  claim 1  wherein disposing the instrument through the first and second seals includes disposing the instrument through a circular opening of the first seal and at least one slit of the second seal. 
     
     
         6 . The method as recited in  claim 1  wherein disposing the instrument includes disposing the instrument through at least the first seal and the second seal, the first seal having a first sealing thickness and the second seal having a second sealing thickness, and the first sealing thickness is different from the second sealing thickness. 
     
     
         7 . A method comprising:
 a) disposing a medical instrument within an introducer, the introducer including at least two valves having a chamber therebetween, the medical instrument having at least two intake/discharge openings; and   b) positioning the at least two intake/discharge openings within the chamber.   
     
     
         8 . The method as recited in  claim 7  further comprising removing the at least two valves from the introducer. 
     
     
         9 . The method as recited in  claim 7  further comprising positioning the at least two valves a distance D apart from each other, and the at least two intake/discharge openings are positioned apart from each other less than D. 
     
     
         10 . The method as recited in  claim 7  further comprising positioning a first intake/discharge opening within a chamber and positioning a second intake/discharge opening outside the chamber without causing an air embolism.