Medical apparatus and method of making the same

Abstract

A hemostatic valve apparatus used in medical procedures that provides rapid activation of a sealing mechanism resulting in lower blood loss during use of the sealing device. The valve apparatus incorporates an actuator and two mechanisms that counter-rotate opposite ends of a sealing tube.

1 . A medical apparatus, comprising:
 a flexible tube;   a first mechanism attached to the tube;   a second mechanism attached to the tube; and   an actuator coupled to the first and second mechanisms,   wherein the actuator is capable of counter rotating the first and second mechanism.   
     
     
         2 . The apparatus of  claim 1 , wherein the actuator is coupled to the first and second rotation mechanisms with gears. 
     
     
         3 . The apparatus of  claim 2 , wherein said gears are selected from the group consisting of a spur gear, helical gear, bevel gear, worm gear, and combinations thereof. 
     
     
         4 . The apparatus of  claim 1 , wherein said medical apparatus prevents the loss of bodily fluids. 
     
     
         5 . The apparatus of  claim 1 , wherein said medical apparatus is a vascular introducer sheath. 
     
     
         6 . The apparatus of  claim 1 , wherein said medical apparatus further comprises a latch or means of holding said actuator in place once said tube is twisted. 
     
     
         7 . The apparatus of  claim 1 , wherein counter rotating the first and second rotation mechanisms twists said tube and forces said tube to collapse around at least one medical device inserted into said tube. 
     
     
         8 . The apparatus of  claim 7 , wherein said medical device is selected from the group consisting of catheters, sheaths, and guidewires. 
     
     
         9 . The apparatus of  claim 1 , wherein the tube has a substantial circular cross section. 
     
     
         10 . The apparatus of  claim 1 , wherein the tube has a polygon cross-section. 
     
     
         11 . The apparatus of  claim 1 , wherein the tube has an inner diameter of at least 3 mm. 
     
     
         12 . The apparatus of  claim 1 , wherein the tube comprises a material selected from the group consisting of expanded polytetrafluoroethelene (ePTFE), silks, polyester weaves and porous filled materials. 
     
     
         13 . The apparatus of  claim 1 , wherein the wherein the tube comprises two or more different materials having different mechanical properties such as durometers or degrees of elasticity. 
     
     
         14 . The apparatus of  claim 1 , further comprising another sealing mechanism. 
     
     
         15 . The apparatus of  claim 14 , wherein said additional sealing mechanism is selected from the group consisting of elastic diaphragm, compression fitting, cap, second tube, brushes, and an inflatable valve. 
     
     
         16 . The apparatus of  claim 1 , wherein the tube has a length in the range from about 6 to about 25 mm. 
     
     
         17 . The apparatus of  claim 1 , wherein the actuator can be rotated about 180° or less. 
     
     
         18 . The apparatus of  claim 1 , wherein the actuator can be rotated to a maximum of about 360°. 
     
     
         19 . A valve for effecting selective closure of a catheter lumen to control fluid flow thorough said catheter lumen, comprising:
 a flexible tube having a lumen extending from proximal end to a distal end;   a first rotation mechanism attached to the tube, wherein the first rotation mechanism comprises a first gear;   a second rotation mechanism attached to the tube, wherein the second rotation mechanism comprises a second gear; and   an actuator coupled to the first and second rotation mechanisms, wherein the actuator is capable of counter rotating the first and second rotation mechanisms.   
     
     
         20 . The valve of  claim 19 , wherein the first and second gears are selected from the group consisting of a spur gear, helical gear, bevel gear, worm gear, and combinations thereof. 
     
     
         21 . The valve of  claim 19 , wherein the tube comprises a material selected from the group consisting of expanded polytetrafluoroethelene (ePTFE), silks, polyester weaves and porous filled materials. 
     
     
         22 . The valve of  claim 19 , wherein said counter rotating the first and second rotation mechanisms twists said tube to form a sealed tube. 
     
     
         23 . The valve of  claim 19 , wherein counter rotating the first and second rotation mechanisms twists said tube and forces said tube to collapse around at least one medical device inserted into said tube. 
     
     
         24 . The valve of  claim 19 , wherein said valve is a component in a vascular introducer sheath.