Infusion and blood collection device

Abstract

An infusion and blood collection device allows clean blood collections into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies after initial installation. The device includes a fluid flow restriction device to control the blood collection flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the angiocatheter.

1 . An infusion and blood collection apparatus for use with a catheter, a distal end of the catheter configured for insertion into a blood vessel, the apparatus comprising:
 an IV infusion lumen attachable to the catheter and defining a distal end, the IV infusion lumen configured for insertion into the blood vessel with the distal end of the IV infusion lumen extending into the blood vessel a specified distance beyond the distal end of the catheter;   an IV fluid inlet fluidly connected to the IV infusion lumen and configured for fluidic connection to an IV fluid source;   a draw port configured for fluid connection to a blood collection channel at least in part defined by a radial space between the interior surface of the catheter and an outside surface of the IV infusion lumen, the draw port configured for fluidic connection to a vacuum source; and   a fluid flow restriction device configured and sized to limit a flow rate of blood drawn through the distal end of the catheter to a preselected flow rate preventing IV fluid exiting the distal end of the IV infusion lumen from entering the distal end of the catheter when the catheter and IV infusion lumen are inserted into the blood vessel, the IV fluid inlet is fluidly connected to the IV fluid source, and the draw port is fluidly connected to the vacuum source.   
     
     
         2 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device defines an internal cross-section sized so that the preselected flow rate is 30 ml/min or less. 
     
     
         3 . The infusion and blood collection apparatus of  claim 2 , wherein the internal cross-section is sized so that the preselected flow rate is 15 ml/min or less. 
     
     
         4 . The infusion and blood collection apparatus of  claim 1 , wherein the specified distance is at least 10 mm. 
     
     
         5 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device is sized to limit the flow rate of blood drawn through the distal end of the catheter to a value of 30 ml/min or less when the specified distance is at least 10 mm, the catheter and IV infusion lumen are inserted into a blood vessel, the IV fluid inlet is fluidly connected to an IV fluid source, and the draw port is fluidly connected to a vacuum source. 
     
     
         6 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device includes a section of reduced internal cross-section for blood draw flow between the distal end of the catheter and the draw port. 
     
     
         7 . The infusion and blood collection apparatus of  claim 6 , wherein the fluid flow restriction device comprises a length of 24-gauge stainless steel hypodermic round tubing. 
     
     
         8 . The infusion and blood collection apparatus of  claim 7 , further comprising a blood collection component that includes the fluid flow restriction device, and wherein at least a portion of the fluid flow restriction device extends within the draw port. 
     
     
         9 . The infusion and blood collection apparatus of  claim 8 , wherein at least a portion of the fluid flow restriction device fluidly couples the vacuum source to the draw port. 
     
     
         10 . The infusion and blood collection apparatus of  claim 6 , wherein the IV infusion lumen is positioned within an interior of the catheter and the section of reduced internal cross-section is defined by a section of reduced clearance between an outside surface of the IV infusion lumen and the interior surface of the catheter. 
     
     
         11 . The infusion and blood collection apparatus of  claim 6 , wherein the fluid flow restriction device comprises a valve and the section of reduced internal cross-section is defined by active control of the valve. 
     
     
         12 . The infusion and blood collection apparatus of  claim 1 , wherein the IV infusion lumen is 24 to 25 gauge and the catheter is 18 to 20 gauge. 
     
     
         13 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device is sized to correspond with a vacuum pressure of the vacuum source. 
     
     
         14 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device is sized to achieve a volume flow rate of 30 ml/min or less when the vacuum pressure is 700 mmHg or less. 
     
     
         15 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device comprises a check valve with a tuned reverse flow rate. 
     
     
         16 . The infusion and blood collection apparatus of  claim 1 , wherein the fluid flow restriction device comprises a pump having a controllable flow rate. 
     
     
         17 . An infusion and blood collection apparatus, comprising:
 a catheter defining a distal end, the distal end of the catheter configured for insertion into a blood vessel;   an IV infusion lumen located within the catheter and defining a distal end, the IV infusion lumen configured for the distal end of the IV infusion lumen to extend into the blood vessel a specified distance beyond the distal end of the catheter;   an IV fluid inlet fluidly connected to the IV infusion lumen and configured for fluidic connection to an IV fluid source;   a draw port fluidly connected to a radial space between the interior surface of the catheter and the outside surface of the IV infusion lumen; and   a blood collection component configured for releasable fluidic connection to the draw port; and   wherein the blood collection component:
 includes a fluid flow restriction device having a first portion configured for fluidic connection to the draw port and a second portion configured for fluidic connection to a vacuum source; and 
 is sized to limit a flow rate of blood drawn through the distal end of the catheter to a preselected flow rate preventing IV fluid exiting the distal end of the IV infusion lumen from entering the distal end of the catheter when the catheter and IV infusion lumen are inserted into the blood vessel, the IV fluid inlet is fluidly connected to the IV fluid source, and the second portion of the fluid flow restriction device is fluidly connected to the vacuum source. 
   
     
     
         18 . The infusion and blood collection apparatus of  claim 17 , wherein the fluid flow restriction device comprises a length of rigid tubing having an interior diameter sized to limit a flow rate of the blood drawn. 
     
     
         19 . An infusion and blood collection apparatus, comprising:
 a catheter defining a distal end, the distal end of the catheter configured for insertion into a blood vessel;   an IV infusion lumen extending through an interior of the catheter and defining a distal end, the distal end of the IV infusion lumen extending into the blood vessel at least 10 mm beyond the distal end of the catheter;   an IV fluid inlet fluidly connected to the IV infusion lumen and configured for fluidic connection to an IV fluid source;   a blood collection channel defined at least in part by a radial space between the interior surface of the catheter and an outside surface of the IV infusion lumen;   a draw port fluidly connected to the blood collection channel and configured for fluidic connection to a vacuum source; and   a fluid flow restriction device sized to limit a flow rate of blood drawn through the blood collection channel to 30 ml/min or less when the draw port is fluidly connected to the vacuum source.   
     
     
         20 . The infusion and blood collection apparatus of  claim 19 , further comprising a blood collection device, and wherein the blood collection device includes the fluid flow restriction device and the fluid flow restriction device is releasably fluidly coupled between the draw port and the vacuum source.