Valved Catheters Including High Flow Rate Catheters

Abstract

A pressure activated two-way slit valve assembly is designed to be used in combination with, but not limited to, a high flow rate catheter to prevent accidental ingestion of air or loss of blood if the closure cap comes off during non-use of the catheter. In addition, the potential for occlusion of the catheter due to blood clots in the catheter and catheter related infection is substantially reduced. The pressure activated two-way slit valve assembly includes a first end, a second end, a wall defining a dumbbell shaped channel, and a flexible, thin disk having a slit and positioned within the pressure activated two-way slit valve assembly to reside within the dumbbell shaped channel. The slit and the dumbbell shaped channel are sized to enable the slit to deform in response to a predetermined pressure differential across the slit to allow fluid to pass therethrough.

What is claimed is: 
     
         1 . A system for delivering fluid, the system comprising:
 a catheter having a distal end and a proximal end and at least one lumen extending therethrough;   a hub having a proximal end and a distal end, the distal end of the hub is in contact with the proximal end of the catheter;   at least one extension leg having a proximal end and a distal end, the distal end of the at least one extension leg being in contact with the proximal end of the hub;   at least one valve housing, the valve housing comprised of a first housing, a second housing, and a connection area, the first housing body having a proximal end and a distal end, the second housing body having a proximal end and a distal end, the distal end of the first housing body is in contact with the proximal end of the at least one extension leg, the connection area is where the proximal end of the first valve housing is in contact with the distal end of the second valve housing;   the at least one valve housing have an area of greatest diameter located substantially at the connection area, the first housing having an area that tapers in a lesser diameter away from the connection area in a distal direction, the second housing having an area that tapers in a lesser diameter away from connection area in a proximal direction;   the valve housing further comprising a flexible valve, the flexible valve having at least one slit to permit the flow of fluid between the first valve housing and the second valve housing, the flexible valve having a first threshold pressure and a second threshold pressure that is different from the first threshold pressure.   
     
     
         2 . The system of  claim 1 , wherein the first housing and the second housing are permanently connected. 
     
     
         3 . The system of  claim 1 , wherein the first housing further comprises a lumen having an area that tapers in a lesser diameter away from the connection area in a distal direction for a selected distance. 
     
     
         4 . The system of  claim 1 , wherein first housing further comprises a lumen having a first cross-sectional diameter and a second cross-sectional diameter, wherein the first cross-sectional diameter is less than the second cross-sectional diameter. 
     
     
         5 . The system of  claim 4 . wherein the first cross-sectional diameter is located proximal to the second cross-sectional diameter. 
     
     
         6 . The system of  claim 5 , wherein second housing further comprises a lumen having a first cross-sectional diameter and a second cross-sectional diameter, wherein the first cross-sectional diameter is less than the second cross-sectional diameter. 
     
     
         7 . The system of  claim 6 , wherein the first cross-sectional diameter is located proximal to the second cross-sectional diameter. 
     
     
         8 . The system of  claim 1 , wherein the flexible valve is secured in the at least one valve housing via an interference fit. 
     
     
         9 . The system of  claim 1 , wherein the slit of the flexible valve is straight. 
     
     
         10 . The system of  claim 1 , wherein the slit of the flexible valve is not straight. 
     
     
         11 . A system for delivering fluid, the system comprising:
 a catheter having a distal end and a proximal end and at least one lumen extending therethrough;   a hub having a proximal end and a distal end, the distal end of the hub is in contact with the proximal end of the catheter;   at least two extension legs having a proximal end and a distal end, the distal end of the at least two extension legs being in contact with the proximal end of the hub;   at least one of the two extension legs further comprising one valve housing, the valve housing comprised of a first housing, a second housing, and a connection area, the first housing body having a proximal end and a distal end, the second housing body having a proximal end and a distal end, the distal end of the first housing body is in contact with the proximal end of the at least one extension leg. the connection area is where the proximal end of the first valve housing is in contact with the distal end of the second valve housing;   the valve housing have an area of greatest diameter located substantially at the connection area, the first housing having an area that tapers in a lesser diameter away from the connection area in a distal direction, the second housing having an area that tapers in a lesser diameter away from connection area in a proximal direction;   the valve housing further comprising a flexible valve, the flexible valve having at least one slit to permit the flow of fluid between the first valve housing and the second valve housing, the flexible valve having a first threshold pressure and a second threshold pressure that is different from the first threshold pressure.   
     
     
         12 . The system of  claim 11 , wherein at least one extension leg does not comprise a valve housing. 
     
     
         13 . A system for delivering fluid, the system comprising:
 a catheter having a distal end and a proximal end and at least one lumen extending therethrough;   at least one valve housing, the valve housing comprised of a first housing, a second housing, and a connection area, the first housing body having a proximal end and a distal end, the second housing body having a proximal end and a distal end;   the at least one valve housing have an area of greatest diameter located substantially at the connection area, the first housing having an area that tapers in a lesser diameter away from the connection area in a distal direction, the second housing having an area that tapers in a lesser diameter away from connection area in a proximal direction;   the valve housing further comprising a flexible valve, the flexible valve having at least one slit to permit the flow of fluid between the first valve housing and the second valve housing, the flexible valve having a first threshold pressure and a second threshold pressure, the first threshold pressure is a result of fluid flowing in a distal direction, the second threshold pressure is a result of fluid flowing in a proximal direction.   
     
     
         14 . The system of  claim 13 , wherein the threshold pressure differential is determined by at least one of the following: (i) a thickness of the flexible valve; (ii) a size of the slit; (iii) a hardness of the material used to form the flexible valve; or (iv) a tapering cross-sectional luminal area of the first housing and the second housing. 
     
     
         15 . The system of  claim 13 , wherein the first threshold pressure is higher than the second threshold pressure. 
     
     
         16 . The system of  claim 13 , wherein the first threshold pressure is tower than the second threshold pressure.