Erythrocyte sedimentation rate (ESR) test measurement instrument of unitary design and method of using the same

Abstract

An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration. The ESR measurement instrument comprises a sedimentation measurement tube having an hollow interior volume containing a predetermined quantity of blood sample diluting agent therewithin and being air/fluid sealed with respect to the ambient environment; and a blood collection tube having a hollow interior volume containing a predetermined quantity of anti-coagulant and being vacuum-sealed with respect to the ambient environment, and physically coupled to the air-sealed sedimentation measurement tube, by at least a portion of the sedimentation measurement tube being inserted within a portion of the hollow interior volume of the blood collection tube. The sedimentation measurement tube and the blood collection tube are maintained stationarily fixed relative to each other as a unitary assembly having a syringe-like form factor when the ESR measurement instrument is arranged in the Blood Collection Configuration. During this configuration, a needle-supporting connector can be connected to the blood collection tube and a sample of whole blood from a patient vacuum-drawn and injected into the blood collection tube. After the sample of anti-coagulated blood has been collected in the blood collection tube and the needle-supporting connector is disconnected therefrom, the air/fluid seal of the sedimentation measurement tube can be broken and then the sedimentation measurement tube can be manually plunged into and to the bottom of the hollow interior volume of said blood collection tube, using a single-handed operation to rearrange the ESR measurement instrument into the ESR Measurement Configuration. The anti-coagulated sample of blood fills up a substantially portion of the sedimentation measurement tube and mixes with the blood sample diluting agent to enable the blood plasma/erythrocyte cell (P/E) interface level within the sedimentation measurement tube to settle downwards toward the blood collection tube during a predetermined time period when said ESR measurement instrument is oriented in a gravity vertical position. By virtue of the present invention, the erythrocyte sedimentation rate (ESR) of the collected blood sample can be measured by determining how far the P/E interface level has moved against graduation markings formed along the length of the sedimentation measurement tube during the predetermined time period.

1 - 25 . (canceled)  
   
   
       26 . An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration, said ESR measurement instrument comprising: 
 a sedimentation measurement tube having an hollow interior volume containing a predetermined quantity of blood sample diluting agent therewithin and being air/fluid sealed with respect to the ambient environment; and    a blood collection tube having a hollow interior volume containing a predetermined quantity of anti-coagulant, and being physically coupled to said air-sealed sedimentation measurement tube, by at least a portion of said sedimentation measurement tube being inserted within a portion of the hollow interior volume of said blood collection tube;    wherein said sedimentation measurement tube and said blood collection tube are maintained stationarily fixed relative to each other as a unitary assembly when said ESR measurement instrument is arranged in said Blood Collection Configuration, during which a needle-supporting connector can be connected to said blood collection tube and a sample of whole blood from a patient drawn and injected into said blood collection tube; and    wherein after the sample of anti-coagulated blood has been collected in said blood collection tube and the needle-supporting connector is disconnected therefrom, the air/fluid seal of said sedimentation measurement tube can be broken and then said sedimentation measurement tube can be manually plunged into and to the bottom of the hollow interior volume of said blood collection tube, so as to rearrange said ESR measurement instrument into said ESR Measurement Configuration,    whereby the anti-coagulated sample of blood fills up a substantially portion of said sedimentation measurement tube and mixes with said blood sample diluting agent to enable the blood plasma/erythrocyte cell (P/E) interface level within said sedimentation measurement tube to settle downwards toward said blood collection tube during a predetermined time period when said ESR measurement instrument is oriented in a gravity vertical position, so that the erythrocyte sedimentation rate (ESR) of said collected blood sample can be measured by determining how far said P/E interface level has moved against graduation markings formed along the length of said sedimentation measurement tube during said predetermined time period.    
   
   
       27 . The ESR measurement instrument of  claim 26 , wherein said blood collection tube is vacuum sealed.  
   
   
       28 . The ESR measurement instrument of  claim 26 , wherein said unitary assembly has a syringe-like form factor.  
   
   
       29 . The ESR measurement instrument of  claim 28 , wherein said blood collection tube has (i) a hollow interior cylindrical volume of a predetermined internal diameter for receiving the sample of whole human blood during blood collection operations, (ii) a pair of low-relief flanges projecting about the outer end surface of the blood collection tube for gripping a rubber needle-pierceable cap with a thick self-sealing end portion and thinner wall portions that snap fit over the low-relief flanges and the outer end portion of the blood collection tube during assembly, and (iii) a large annular flange projecting from the outer end of the blood collection tube at its opposite end, for engagement with the fingers of a person pushing said sedimentation measurement tube within the blood collection tube with his or her thumb.  
   
   
       30 . The ESR measurement instrument of  claim 26 , wherein said sedimentation measurement tube has (i) a hollow central bore of a predetermined diameter and an outer diameter slightly smaller than the interior diameter of the hollow interior volume of the blood collection tube, (ii) a series of graduation marks formed along the exterior surface of the sedimentation measurement tube for indicating the ESR of a whole blood sample in accordance with the ESR measurement method of the present invention, (iii) a plurality of low-relief plunger gripping flanges projecting from the opposite end of the sedimentation measurement tube for retaining a rubber plunger having a hollow inner volume bounded on its closed end by a thin, rupturable wall membrane, and having outer wall surfaces which slide over the free end of said sedimentation measurement tube and engage the flanges projecting therefrom.  
   
   
       31 . The ESR measurement instrument of  claim 30 , wherein said sedimentation measurement tube has a large annular flange projecting from its outer end at the end opposite the rubber plunger, for engagement with the thumb of the person pushing the sedimentation measurement tube within the blood collection tube when rearranging the ESR measurement instrument into said ESR Measurement Configuration.  
   
   
       32 . The ESR measurement instrument of  claim 30 , wherein an air/fluid flow restriction plug is insertable into the top end portion of said sedimentation measurement tube so as to restrict or occlude the flow of air from the ambient environment and the interior of the hollow central bore while the ESR measurement instrument is arranged in said Blood Collection Configuration.  
   
   
       33 . The ESR measurement instrument of  claim 30 , wherein a rubber washer, slidable over the plunger gripping flanges, before the rubber plunger is attached to the end of the sedimentation measurement tube, for creating a liquid seal between outer walls of said sedimentation measurement tube and the inner walls of said blood collection tube.  
   
   
       34 . The ESR measurement instrument of  claim 26 , wherein means is provided for maintaining the plunger portion of the sedimentation measurement tube within the upper portion of the blood collection tube in a stationary position with respect to each other while the predetermined quantity of anti-coagulant is contained within the vacuum-sealed blood collection tube while the ESR measurement instrument is arranged in said Blood Collection Configuration.  
   
   
       35 . A method of ESR measurement using an ESR measurement instrument having a unitary construction, said method comprising the steps of: 
 (a) injecting the needle of blood collecting apparatus through a rubber cap associated with a blood collection tube that contains a predetermined quantity of anti-coagulant within the hollow interior volume of said blood collection tube and which is further integrated with a sedimentation measurement tube that is air/fluid-sealed and contains a predetermined quantity of blood sample diluting agent, wherein a liquid seal is disposed between the interior volume of said blood collection tube and said sedimentation measurement tube;    (b) drawing a sample of whole blood from a patient's body and collecting said sample through said needle and into said blood collection tube, wherein the collected sample of whole blood mixes with said predetermined quantity of anti-coagulant within said blood collection tube;    (c) withdrawing said needle from said blood collecting device;    (d) breaking the air/fluid seal of said sedimentation measurement device; and    (e) breaking the liquid seal between said sedimentation measurement tube and said blood collection tube by manually pushing said sedimentation measurement tube into the hollow interior volume of said blood collection tube,    thereby causing the sample of anti-coagulated blood to fill up a substantial portion of said sedimentation measurement tube, and mix with said predetermined quantity of blood sample diluting agent, and    whereby the blood plasma/erythrocyte cell (P/E) interface level within said sedimentation measurement tube is permitted to flow down towards said blood collection tube over a predetermined time period when said ESR measurement instrument is supported in a gravity vertical direction during said predetermined time period, so that the erythrocyte sedimentation rate (ESR) of said collected blood sample can be measured by determining how far said P/E interface level has moved against graduation markings formed along the length of said sedimentation measurement tube during said predetermined time period.    
   
   
       36 . The method of ESR measurement of  claim 35 , wherein said blood collection tube is vacuum-sealed.  
   
   
       37 . An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration, said ESR measurement instrument comprising: 
 a sedimentation measurement tube having an hollow interior volume; and    a blood collection tube having a hollow interior volume containing a predetermined quantity of anti-coagulant and a predetermined quantity of blood sample diluting agent therewithin, and physically coupled to said sedimentation measurement tube by at least a portion of said sedimentation measurement tube being inserted within a portion of the hollow interior volume of said blood collection tube;    wherein said sedimentation measurement tube and said blood collection tube are maintained stationarily fixed relative to each other as a unitary assembly when said ESR measurement instrument is arranged in said Blood Collection Configuration, during which a needle-supporting connector can be connected to said blood collection tube and a sample of whole blood from a patient drawn and injected into said blood collection tube; and    wherein after the sample of whole blood has been collected in said blood collection tube and mixes with said anti-coagulating agent and said predetermined quantity of blood sample diluting agent, the needle-supporting connector is disconnected therefrom, and said sedimentation measurement tube can be manually plunged into and to the bottom of the hollow interior volume of said blood collection container, so as to rearrange said ESR measurement instrument into said ESR Measurement Configuration,    whereby the anti-coagulated sample of blood fills up a substantially portion of said sedimentation measurement tube and the blood plasma/erythrocyte cell (P/E) interface level within said sedimentation measurement tube settles downwards toward said blood collection tube during a predetermined time period when said ESR measurement instrument is oriented in a gravity vertical position, so that the erythrocyte sedimentation rate (ESR) of said collected blood sample can be measured by determining how far said P/E interface level has moved against graduation markings formed along the length of said sedimentation measurement tube during said predetermined time period.    
   
   
       38 . The ESR measurement instrument of  claim 37 , wherein said blood collection tube is vacuum sealed, and said unitary assembly has a syringe-like form factor.  
   
   
       39 . The ESR measurement instrument of  claim 37 , wherein said sedimentation measurement tube can be manually plunged into and to the bottom of the hollow interior volume of said blood collection container, using a single handed operation, so as to rearrange said ESR measurement instrument into said ESR Measurement Configuration.  
   
   
       40 . The ESR measurement instrument of  claim 37 , wherein said blood collection tube has (i) a hollow interior cylindrical volume of a predetermined internal diameter for receiving the sample of whole human blood during blood collection operations, (ii) a pair of low-relief flanges projecting about the outer end surface of the blood collection tube for gripping a rubber needle-pierceable cap with a thick self-sealing end portion and thinner wall portions that snap fit over the low-relief flanges and the outer end portion of the blood collection tube during assembly, and (iii) a large annular flange projecting from the outer end of the blood collection tube at its opposite end, for engagement with the fingers of a person pushing said sedimentation measurement tube within the blood collection tube with his or her thumb.  
   
   
       41 . The ESR measurement instrument of  claim 40 , wherein said sedimentation measurement tube has (i) a hollow central bore of a predetermined diameter and an outer diameter slightly smaller than the interior diameter of the hollow interior volume of the blood collection tube, (ii) a series of graduation marks formed along the exterior surface of the sedimentation measurement tube for indicating the ESR of a whole blood sample in accordance with the ESR measurement method of the present invention, (iii) a plurality of low-relief plunger gripping flanges projecting from the opposite end of the sedimentation measurement tube for retaining a rubber plunger having a hollow inner volume bounded on its closed end by a thin, rupturable wall membrane, and having outer wall surfaces which slide over the free end of said sedimentation measurement tube and engage the flanges projecting therefrom.