Valved Sheath Introducer For Venous Cannulation

Abstract

A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

What is claimed is: 
     
         1 . A method of making a sheath introducer, comprising:
 coupling a handle to a sheath having a lumen, the handle including:
 a bore communicating with the lumen; 
 a first receiving section; and 
 a second receiving section; 
   inserting a valve into the handle, comprising:
 inserting a central portion of the valve into the bore, the central portion having a first thickness, the central portion including a slit through the first thickness; 
 inserting a first anchoring member of the valve into the first receiving section, the first anchoring member having a second thickness; and 
 inserting a second anchoring member of the valve into the second receiving section, the second anchoring member having the second thickness; and 
   attaching a cap to the handle under pressure to compress a portion of the valve between the cap and the handle.   
     
     
         2 . The method of making according to  claim 1 , wherein the coupling step comprises insert molding the handle over a proximal end of the sheath. 
     
     
         3 . The method of making according to  claim 1 , wherein the first receiving section of the handle is on a first side of the bore, and wherein the second receiving section of the handle is on a second side of the bore opposite of the first side of the bore. 
     
     
         4 . The method of making according to  claim 1 , wherein the central portion of the valve has a thickness greater than a portion of the valve surrounding the central portion. 
     
     
         5 . The method of making according to  claim 1 , wherein the central portion of the valve has a concave surface on one side thereof. 
     
     
         6 . The method of making according to  claim 5 , wherein the central portion of the valve has opposing concave surfaces. 
     
     
         7 . The method of making according to  claim 1 , wherein the central portion of the valve has a diameter approximately equal to a diameter of the bore of the handle. 
     
     
         8 . The method of making according to  claim 1 , wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section. 
     
     
         9 . The method of making according to  claim 8 , wherein the slit of the valve is perpendicularly aligned with the opposing slotted regions. 
     
     
         10 . The method of making according to  claim 9 , further comprising looping a wire through the slit, wherein the inserting step comprises disposing both a first end of the wire and a second end of the wire in either the first receiving section or the second receiving section of the handle. 
     
     
         11 . The method of making according to  claim 1 , wherein the slit forms an acute angle with respect to a top surface of the valve. 
     
     
         12 . The method of making according to  claim 1 , wherein the slit of the valve is positioned in a center of the central portion, and wherein the valve further comprises a second slit aligned with the slit, the second slit positioned at an outer edge of the valve. 
     
     
         13 . The method of making according to  claim 12 , wherein the valve further comprises a third slit aligned with the slit, and wherein the third slit is positioned at a first edge of the valve and the second slit is positioned at a second edge of the valve opposite of the first edge of the valve. 
     
     
         14 . The method of making according to  claim 13 , wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section, and wherein the second slit and the third slit are aligned with the opposing slotted regions. 
     
     
         15 . The method of making according to  claim 1 , wherein the slit of the valve is positioned in a center of the central portion, and wherein the valve further comprises a first notch aligned with the slit, the first notch positioned at an outer edge of the valve. 
     
     
         16 . The method of making according to  claim 15 , wherein the valve further comprises a second notch aligned with the slit, wherein the first notch is positioned at a first edge of the valve and the second notch is positioned at a second edge of the valve opposite of the first edge of the valve. 
     
     
         17 . The method of making according to  claim 16 , wherein the handle includes opposing slotted regions between the first receiving section and the second receiving section, and wherein the first notch and the second notch are aligned with the opposing slotted regions. 
     
     
         18 . The method of making according to  claim 1 , wherein the attaching step comprises ultrasonically welding the cap to the handle. 
     
     
         19 . The method of making according to  claim 1 , wherein the coupling step comprises coupling a first part of the cap to a first side of the handle and attaching a second part of the cap to a second side of the handle such that a gap between the first part of the cap and the second part of the cap is aligned with one or more slotted regions in the handle. 
     
     
         20 . The method of making according to  claim 1 , wherein the first thickness is less than the second thickness.