US2013116597A1PendingUtilityA1

Method and apparatus for acquiring blood for testing

38
Assignee: PHENOMENEX INCPriority: Nov 4, 2011Filed: Nov 2, 2012Published: May 9, 2013
Est. expiryNov 4, 2031(~5.3 yrs left)· nominal 20-yr term from priority
A61B 5/150351B01L 3/5023A61B 5/150022B01L 2300/105A61B 5/150358A61B 5/150213B01L 2200/0678B01L 3/5085B01L 9/543B01L 3/0275B01L 3/50A61B 5/150343A61B 5/150305A61B 5/150755G01N 2001/4027B01L 2300/069
38
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Claims

Abstract

A blood sampling device is provided having holder with a manipulating end and an absorbent probe on the opposing end. The probe is of hydrophilic polymer sized to directly absorb a predetermined volume of up to about 30 microliters of blood. Ribs on the holder position the probe within a compartment of a container to prevent contact with the container. The ribs also position the probe within extraction wells.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A biological fluid sampling device, comprising:
 an absorbent probe made of a hydrophilic polymeric material of sufficient size to absorb for analysis a maximum of about 20 μl of blood in about 2-5 seconds without separating the blood from plasma, the probe having a length of less than about 5 mm and a cross-sectional area of less than about 20 mm 2  and a density of less than about 4 g/cc with a majority of the exterior surface of the probe being exposed and available for placing against a fluid sample on a surface to absorb the sample; and   a holder connected to the probe.   
     
     
         2 . The device of  claim 1 , wherein the holder is dimensionally suited for use with devices that can manipulate a pipette tip. 
     
     
         3 . The device of  claim 1 , wherein the holder is disposable and the probe has a pore volume of about 40%. 
     
     
         4 . The device of  claim 1 , wherein the density is about 0.6 g/cc and the volume is about 25 microliters. 
     
     
         5 . The device of  claim 1 , wherein the probe has a cylindrical portion that is sized to fit into a mating opening in the holder to connect the holder to the probe. 
     
     
         6 . The device of  claim 1 , wherein the probe is made of polyethylene. 
     
     
         7 . The device of  claim 1 , wherein the probe and holder are sterile and packaged in a sterile container. 
     
     
         8 . The device of  claim 1 , wherein the probe contains dried anti-coagulant. 
     
     
         9 . The device of  claim 1 , wherein the probe contains at least one of a reference standard, a dried stabilizer or a modifier. 
     
     
         10 . The device of  claim 1 , wherein the probe contains dried blood. 
     
     
         11 . The device of  claim 1 , wherein the holder has a plurality of ribs extending along a length of the holder, the ribs having a height and length selected to keep the probe from contacting walls of a recess into which the holder and probe are placed for shipment or for extraction of the dried blood. 
     
     
         12 . The device of  claim 11 , wherein the holder has a hollow end opposite the probe and further comprising a container having a first portion with a mounting projection sized to fit into and releasably engage the hollow end of the holder, the container having a second portion releasably fastened to the first portion and having a recess configured to enclose a portion of the holder for transportation of the holder. 
     
     
         13 . The device of  claim 11 , wherein the container has a plurality of openings allowing air to access the probe. 
     
     
         14 . The device of  claim 11 , wherein the first portion has a side with an access port therein of sufficient size and located so that indicia may be applied through the port and onto the holder when the holder is on the mounting projection. 
     
     
         15 . The device of  claim 1 , wherein there are a plurality of holders each with a probe, and wherein each of the plurality of holders has a hollow end opposite its probe and further comprising a container having a first portion with a plurality of elongated mounting projections each sized to fit into and releasably engage one of the hollow ends of the plurality of holders, the container having a second portion releasably fastened to the first portion, the container having a recess configured to separately enclose each of the plurality of holders in a separate enclosure within the container. 
     
     
         16 . The device of  claim 15 , wherein a plurality of the holders each has a plurality of ribs extending along a length of the holder, the ribs configured to keep the probe from contacting walls of the container. 
     
     
         17 . The device of  claim 15 , wherein at least two of the probes contain dried blood. 
     
     
         18 . The device of  claim 16 , further comprising a desiccant inside the container. 
     
     
         19 . The device of  claim 15 , wherein each holder contains visible indicia associating the holder with the container and with at least one other holder. 
     
     
         20 . A process for use in testing a blood sample, comprising:
 placing an absorbent probe in physical contact with a blood sample, the probe being made of a hydrophilic polymeric material and connected to a holder, the absorbent probe being configured to absorb a predetermined maximum volume of blood of about 1 to 30 micro liters, the absorbent probe having a majority of its exterior surface exposed and accessible for absorption of blood from a surface;   maintaining a portion of the exterior surface of the probe in contact with the blood sample until the predetermined amount of blood is absorbed by the probe;   removing the probe from contact with the blood; and   drying the blood in the probe without contaminating the blood.   
     
     
         21 . The process of  claim 20 , wherein the predetermined time is less than about five seconds. 
     
     
         22 . The process of  claim 20 , wherein the blood sample is on a live animal when contacted by the probe. 
     
     
         23 . The process of  claim 20 , wherein the probe is configured to absorb a predetermined amount of blood of about 5-15 microliters. 
     
     
         24 . The process of  claim 20 , wherein said majority of the exterior surface of the probe has a porosity of about 30% to 50%. 
     
     
         25 . The process of  claim 20 , further comprising placing the probe with the dried blood in a compartment within a container. 
     
     
         26 . The process of  claim 20 , further comprising placing the probe with dried blood in a container with fluid selected to reconstitute the dried blood in the probe. 
     
     
         27 . The process of  claim 20 , comprising a plurality of probes each held in a pipette tip and each containing dried blood, the pipette tips being held in a tray. 
     
     
         28 . The process of  claim 20 , wherein the holder comprises a plurality of ribs configured to prevent the probe from contacting at least one of the walls of a shipping container in which the holder is placed or the walls of a recess in which the probe is placed to extract the dried blood. 
     
     
         29 . The process of  claim 28 , wherein the holder has a position stop located to position the probe within at least one of a container or a well plate so as to prevent the probe from contacting the container or well plate. 
     
     
         30 . A kit for collecting body fluids, comprising:
 a plurality of elongated holders each having a manipulating end and opposite thereto an absorbent probe made of a hydrophilic, polymeric material configured to absorb a predetermined volume of about 30 microliters or less of blood within about 2-5 seconds, the probe having a majority of its exterior surface exposed for use in absorbing the blood and in drying the absorbed blood;   a container having a plurality of compartments, each configured to releasably receive a different one of the elongated holders and its probe, the container and holder configured to prevent the probes from abutting the compartment within which the holder and probe are placed, the container having openings in each compartment to allow air to enter each of the compartments and reach the probe within the compartment with which the openings are associated.   
     
     
         31 . The kit of  claim 30 , further comprising a plurality of access ports with each port associated with a different one of the compartments, each port located to allow printing onto the manipulating end of the holder in the compartment with which the port is associated. 
     
     
         32 . The kit of  claim 30 , wherein at least some of the holders have a plurality of ribs extending along a length of the holder and located between the manipulating end and the probe, the ribs cooperating with the container to prevent the probe from abutting the compartment within which said ribbed holder is placed. 
     
     
         33 . The kit of  claim 30 , wherein the container has two parts cooperating to form tubular shaped compartments, the container having a first part having a plurality of elongated mounting protrusions each extending along a portion of a different compartment, the manipulating end of the holder configured to fit onto the mounting protrusion to releasably fasten the holders onto the mounting protrusions. 
     
     
         34 . The kit of  claim 30 , further comprising visible indicia on a plurality of holders and the container associating the holders with at least one of the container or another holder within the container. 
     
     
         35 . The kit of  claim 30 , wherein the probes are made of polyethylene and configured to absorb about 1-7 microliters of blood. 
     
     
         36 . The kit of  claim 30 , wherein at least one holder is tubular and the probe on that holder is held within one end of the tubular holder. 
     
     
         37 . The kit of  claim 30 , wherein at least one of the probes contains dried blood. 
     
     
         38 . The kit of  claim 31 , wherein at least one of the probes contains a dried anticoagulant. 
     
     
         39 . The kit of  claim 30 , wherein at least one of the compartments contains a desiccant. 
     
     
         40 . The kit of  claim 30 , wherein about 80% or more of the exterior surface of the probe is exposed for use in absorbing the fluid.

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