Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination

Abstract

The present invention is directed to the parenteral procurement of bodily-fluid samples. The present invention is also directed to systems and methods for parenterally procuring bodily-fluid samples with reduced contamination from dermally-residing microbes. In some embodiments, a bodily-fluid withdrawing system is used to withdraw bodily fluid from a patient for incubation in culture media in one or more sample vessels. Prior to withdrawing bodily fluid into the one or more sample vessels for incubation, an initial volume of withdrawn bodily fluid is placed in one or more pre-sample reservoirs and is not used for the incubation in culture media.

1 .- 20 . (canceled) 
     
     
         21 . A system for obtaining bodily-fluid samples from a patient, comprising:
 a first needle having a lumen configured for insertion into the patient;   a second needle having a lumen configured to be fluidically coupled to the first needle;   an intermediary lumen-containing device configured to fluidically couple the lumen of the first needle to the lumen of the second needle; and   a pre-sample reservoir configured to be fluidically coupled to the lumen of the second needle, the pre-sample reservoir sized and configured to receive a first volume of bodily-fluid from the patient, the first volume of bodily-fluid being (a) greater than the combined volume of the lumen of the first needle, the intermediary lumen-containing device, and the lumen of the second needle, and (b) less than 5 ml,   whereby transferring the first volume of bodily-fluid to the pre-sample reservoir sequesters microbes present in the first volume of bodily-fluid thereby reducing contamination of any subsequent volumes of bodily-fluid withdrawn from the patient.   
     
     
         22 . The system of  claim 21 , wherein sequestering the first volume of bodily-fluid in the pre-sample reservoir reduces false results in culture tests of a subsequent second volume of bodily-fluid by at least about 50%. 
     
     
         23 . The system of  claim 21 , further comprising:
 a guard configured to be disposed over the second needle.   
     
     
         24 . The system of  claim 21 , further comprising:
 a disinfectant for cleansing the patient's skin prior to insertion of the first needle.   
     
     
         25 . The system of  claim 24 , wherein the disinfectant includes an isopropyl alcohol solution. 
     
     
         26 . The system of  claim 24 , wherein the disinfectant includes chlorhexidine gluconate. 
     
     
         27 . The system of  claim 21 , wherein the pre-sample reservoir is configured to receive 0.5 ml to 5 ml of bodily-fluid. 
     
     
         28 . The system of  claim 21 , wherein the pre-sample reservoir is configured to receive 1 ml to 5 ml of bodily-fluid. 
     
     
         29 . The system of  claim 21 , whereby dermally residing microbes dislodged while inserting the first needle into the patient are transferred to and sequestered in the pre-sample reservoir. 
     
     
         30 . The system of  claim 21 , whereby a tissue fragment dislodged while inserting the first needle into the patient is transferred to and sequestered in the pre-sample reservoir. 
     
     
         31 . A system for obtaining bodily-fluid samples from a patient, comprising:
 a first needle configured for insertion into the patient;   a second needle configured to be fluidically coupled to the first needle;   a flexible tube configured to fluidically couple the first needle to the second needle; and   a vacuum-sealed pre-sample reservoir configured to be fluidically coupled to the second needle after the first needle has been inserted into the patient, the vacuum-sealed pre-sample reservoir having a volume in a range of 1 ml to 5 ml,   whereby transferring a first volume of bodily-fluid to the vacuum-sealed pre-sample reservoir sequesters dermally residing microbes dislodged while inserting the first needle into the patient, thereby reducing contamination of any subsequent volumes of bodily-fluid withdrawn from the patient.   
     
     
         32 . The system of  claim 31 , wherein the vacuum-sealed pre-sample reservoir is a single Vacutainer. 
     
     
         33 . The system of  claim 31 , wherein the vacuum-sealed pre-sample reservoir is a first vacuum-sealed pre-sample reservoir, the system further comprising:
 a second vacuum-sealed pre-sample reservoir.   
     
     
         34 . The system of  claim 31 , wherein sequestering the first volume of bodily-fluid in the vacuum-sealed pre-sample reservoir reduces false results in culture tests of a subsequent second volume of bodily-fluid by at least about 50%. 
     
     
         35 . The system of  claim 31 , further comprising:
 a guard configured to be disposed over the second needle.   
     
     
         36 . The system of  claim 31 , further comprising:
 a disinfectant for cleansing the patient's skin prior to insertion of the first needle.   
     
     
         37 . A system for obtaining blood samples from a patient, comprising:
 a first needle configured for insertion into the patient a venipuncture site;   a second needle configured to be fluidically coupled to the first needle;   a flexible tube configured to fluidically couple the first needle to the second needle; and   a vacuum-sealed pre-sample reservoir configured to be fluidically coupled to the second needle after the first needle has been inserted into the patient, the vacuum-sealed pre-sample reservoir sized and configured to draw a first volume of blood from the patient through the first needle, the flexible tube, and the second needle to the vacuum-sealed pre-sample reservoir until a pressure in the vacuum-sealed pre-sample reservoir is substantially equal to a vascular pressure of the patient at the venipuncture site, the first volume of blood in a range of 1 ml to 5 ml,   whereby transferring the first volume of blood to the vacuum-sealed pre-sample reservoir sequesters microbes present in the first volume of blood thereby reducing contamination of any subsequent volumes of blood withdrawn from the patient.   
     
     
         38 . The system of  claim 37 , further comprising:
 a sample vessel including a culture medium.   
     
     
         39 . The system of  claim 37 , further comprising:
 a first sample vessel including a first culture medium; and   a second sample vessel including a second culture medium.   
     
     
         40 . The system of  claim 39 , wherein the second culture medium is different than the first culture medium. 
     
     
         41 . The system of  claim 37 , further comprising:
 a first sample vessel including an aerobic culture medium; and   a second sample vessel including an anaerobic culture medium.   
     
     
         42 . The system of  claim 37 , whereby dermally residing microbes dislodged while inserting the first needle into the patient are transferred to and sequestered in the vacuum-sealed pre-sample reservoir. 
     
     
         43 . The system of  claim 37 , whereby a tissue fragment dislodged while inserting the first needle into the patient is transferred to and sequestered in the pre-sample reservoir. 
     
     
         44 . The system of  claim 37 , wherein sequestering the first volume of bodily-fluid in the pre-sample reservoir reduces false results in culture tests of a subsequent second volume of bodily-fluid by at least about 50%. 
     
     
         45 . The system of  claim 37 , further comprising:
 a guard configured to be disposed over the second needle.   
     
     
         46 . The system of  claim 37 , further comprising:
 a disinfectant for cleansing the patient's skin prior to insertion of the first needle.   
     
     
         47 . A system for obtaining bodily-fluid samples from a patient, the system consisting essentially of:
 a first needle configured for insertion into the patient;   a second needle configured to be fluidically coupled to the first needle;   a flexible tube configured to fluidically couple the first needle to the second needle;   a vacuum-sealed pre-sample reservoir configured to be fluidically coupled to the second needle after the first needle has been inserted into the patient, the vacuum-sealed pre-sample reservoir having a volume in a range of 1 ml to 5 ml,   whereby transferring a first volume of bodily-fluid to the vacuum-sealed pre-sample reservoir sequesters microbes present in the first volume of bodily-fluid thereby reducing contamination of any subsequent volumes of bodily-fluid withdrawn from the patient.   
     
     
         48 . The system of  claim 47 , wherein sequestering the first volume of bodily-fluid in the pre-sample reservoir reduces false results in culture tests of a subsequent second volume of bodily-fluid by at least about 50%. 
     
     
         49 . The system of  claim 47 , whereby dermally residing microbes dislodged while inserting the first needle into the patient are transferred to and sequestered in the pre-sample reservoir. 
     
     
         50 . The system of  claim 47 , whereby a tissue fragment dislodged while inserting the first needle into the patient is transferred to and sequestered in the pre-sample reservoir.