Vacuum Pressure Regulators for Use During Blood Collection

Abstract

A regulator for modulation of the flow rate of blood out of a patient's blood vessel during blood collection is disclosed. The regulator includes a housing having a housing inlet, a housing outlet, and a wall defining a housing interior. At least a portion of the wall includes a flexible member. A valve is associated with the flexible member and is in communication with the housing interior. The regulator is designed so that upon an application of a differential pressure within the housing interior, the flexible member and/or valve automatically move with respect to either the housing inlet or housing outlet to modulate a flow of blood moving through the housing. A manual over-ride device can be provided to enable a user to over-ride the automatic regulation and manually regulate the flow of blood through the housing.

The invention claimed is: 
     
         1 . A method of regulating a flow of blood through a wingset during blood collection comprising:
 associating a vacuum pressure regulator with the wingset, said vacuum pressure regulator including a housing having a housing inlet, a housing outlet, and a wall defining a housing interior, at least a portion of said wall comprising a flexible member, and a valve associated with said flexible member, said valve extending into said housing interior;   inserting a patient end of a cannula of said wingset into a patient; and   connecting a non-patient end of a cannula of said wingset with an evacuated blood collection container, wherein upon an application of the vacuum pressure within the housing interior caused by the connection of the blood collection container causes the flexible member and valve to be automatically moved toward either the housing inlet or housing outlet to restrict an orifice opening of the housing inlet or housing outlet to modulate the flow of blood moving through the housing.   
     
     
         2 . The method of  claim 1  wherein the wingset includes a hub, tubing, and a blood collection holder and wherein the vacuum pressure regulator is directly associated with the hub, positioned in-line with the tubing, or is directly associated with the blood collection holder. 
     
     
         3 . The method of  claim 1  including associating a thumb pad with the flexible member to enable the user to over-ride the automatic regulation of blood flow and to manually regulate the flow of blood through the housing. 
     
     
         4 . The method of  claim 1  wherein the valve comprises one of a needle valve, a poppet valve having a flat shut-off, or a concentric annulus. 
     
     
         5 . The method of  claim 1  including associating a seal ring having a small flow channel with either the housing inlet or the housing outlet of the regulator and wherein the valve comprises the flexible member that is drawn toward the seal ring to cooperate with the seal ring and small flow channel to reduce or restrict the flow of blood through the small flow channel upon the application of the vacuum pressure within the housing interior. 
     
     
         6 . The method of  claim 1  including associating a spring with an atmospheric side of the flexible member. 
     
     
         7 . A wingset including a regulator for flow modulation during blood collection, said wingset comprising:
 a first cannula having a patient end;   a second cannula having a non-patient end;   a hub and tubing positioned between the first and second cannulae;   a tube holder associated with said second cannula, said tube holder configured for receiving a blood collection tube, said blood collection tube including a seal for containing a vacuum therein; and   a regulator associated with either the hub, tubing, or tube holder, said regulator comprising a housing having a housing inlet, a housing outlet, and a wall defining a housing interior, at least a portion of said wall comprising a flexible member and a valve associated with said flexible member, said valve extending into said housing interior, wherein insertion of the blood collection tube within the tube holder and piercing of the seal of the blood collection tube causes an application of a differential pressure within the housing interior, and upon the application of the differential pressure within the housing interior causes the flexible member and valve to be automatically moved toward either the housing inlet or the housing outlet to restrict an orifice opening of the housing inlet or the housing outlet.   
     
     
         8 . The wingset of  claim 7  including a thumb pad associated with the flexible member to enable a user to over-ride the automatic regulation of blood flow and to manually regulate the flow of blood through the housing. 
     
     
         9 . The wingset of  claim 7  wherein the valve comprises one of a needle valve, a poppet valve, or a concentric annulus. 
     
     
         10 . The wingset of  claim 7  wherein the regulator includes a seal ring having a small flow channel associated with either the housing inlet or the housing outlet and wherein the valve comprises the flexible member that is drawn toward the seal ring to cooperate with the seal ring and small flow channel to reduce or restrict the flow of blood through the small flow channel upon an application of a vacuum pressure within the housing interior. 
     
     
         11 . The wingset of  claim 7  including a spring associated with an atmospheric side of the flexible member.