Whole blood sampling device

• US 6,755,802 B2
• Filed: 05/06/2002
• Issued: 06/29/2004
• Est. Priority Date: 05/06/2002
• Status: Expired due to Fees

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Bell, Michael L.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/139,569
• Publication Number:
  US 20030206828A1
• Time in Patent Office: 785 Days
• Field of Search: 604/4.01, 604/6.01, 604/6.04, 604/6.07, 604/6.15, 604/403, 604/405-6, 604/411, 604/415-16, 604/317, 210/644, 210/649-51, 210/348, 210/406, 210/435, 210/437-39, 210/446, 210/448, 210/500.1, 210/500-1-5, 422/100-1, 422/104, 738/63, 738/632.1, 738/632.3, 738/638.1, 738/64, 738/640--86, 738/641.1, 738/642.1, 738/649.1, 738/648--86, 435/283.1, 435/287.1, 435/287.3, 435/297--29, 436/174, 436/177-78, 436/68, 424/520, 424/529-30
• US Class Current: 604/6.15
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: B01D 2313/025 Specific membrane holders
• CPC Class Codes: B01D 2313/206 characterised by the material
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A portable hand-held blood sampling device having a self-filling capability includes a blood separation filter. The filter has a plurality of pores sized to permit passage of selected blood constituents such as blood plasma through the device. The device has a separated blood conduit that extends beyond the outlet of the device and is shaped for easy penetration into a self-sealing septum of a blood analyzer. An annular shield extends from the device outlet beyond the conduit to prevent inadvertent contact of the conduit by a user.

Claims

1. A blood sampling device comprising:

a hollow fluid tight tube having an inlet end defining an inlet chamber and an outlet end, the outlet end providing fluid exhaust from the interior of the tube; and

a hollow fiber filter extending within and along a length of the tube, the filter being sealed at a first end thereof proximate to the inlet end and in fluid communication with the outlet end at a second end thereof, wherein

the filter has a hollow interior and includes a plurality of pores sized to limit the passage of blood constituents from the inlet chamber to the interior of the filter, and to provide passage of blood plasma into the interior of the filter.

2. The device of claim 1, wherein the pores have diameters of about 2 micrometers.

3. The device of claim 2, wherein the pores are disposed along a length of the fiber filter from between the second end and a predetermined distance from the first end of said filter.

4. The device of claim 3 wherein the fiber filter has a cross section smaller than that of the inlet chamber defining thereby a fill volume there between.

5. The device of claim 4, wherein the predetermined distance is at a location that corresponds to no more than half of the fill volume.

6. The device of claim 1, wherein the pores have diameters in the range of about 0.1 to 1.0 micrometers.

7. The device of claim 1, wherein the inlet chamber defines (a) an inlet chamber wall having a wettable surface;

and (b) a cross sectional area dimensioned such that the inlet chamber is self filling under the influence of capillary action.

8. The device of claim 7 wherein the inlet chamber contains an anticoagulant reagent to inhibit clotting.

9. The blood sampling device of claim 1 wherein at least one of the blood constituents is blood cells and the filter limits the passage of blood cells from the inlet chamber to the interior of the filter and allows the passage of blood plasma through the filter and into the hollow interior of the filter.

10. The blood sampling device of claim 1 wherein the device includes a hollow stent mounted to the fiber filter, the stent (a) extending from between the interior and exterior of the tube at the outlet end;

and (b) providing an exhaust path from the interior of the filter.

11. A method of sampling blood comprising:

a) selecting the device of claim 1;

b) contacting the inlet end of the device with a blood sample;

c) drawing the blood sample into the inlet chamber of the device;

d) passing the blood plasma through the pores of the filter and into the interior of the filter, thereby separating the blood plasma from the blood sample; and

e) withdrawing the blood plasma from the interior of the filter through the outlet end of the tube.

12. A method according to claim 11, wherein the blood sample is drawn into the inlet chamber by capillary action.

13. A method according to claim 11, wherein the blood plasma is withdrawn from the interior of the filter by inserting the device into the sampling port of an analyzer and aspirating the blood plasma through the outlet end of the tube and into the analyzer.

14. A blood sampling device comprising:

a hollow fluid tight tube having an inlet defining an inlet chamber for receiving blood to be sampled and an outlet, the outlet providing fluid exhaust from the interior of the tube, said inlet chamber defining (a) an inlet chamber wall having a wettable surface; and

(b) a cross sectional area dimensioned such that the inlet chamber is self filling under the influence of capillary action; and

a blood separation filter positioned within the tube and adapted to separate blood elements from the blood and exhaust such separated blood elements through the outlet of the tube.

15. The blood sampling device of claim 14 wherein the separation filter comprises a hollow elongated fiber filter sealed at one end and coupled to the outlet at the other end, the filter having a hollow interior and a plurality of pores to provide a passageway for blood elements from the inlet chamber to the interior of the filter.

16. The blood sampling device of claim 15 wherein the pores are sized to limit the passage of blood cells to the interior of the filter and to provide passage of blood plasma into the interior of the filter.

18. The device of claim 16, wherein the pores have diameters in the range of about 0.1 to 1.0 micrometers.

19. The blood sampling device of claim 14 wherein the outlet includes an end cap for providing a fluid tight seal of the outlet, the end cap including a hollow stent extending from between the interior and exterior of the tube at the outlet thereof, the stein in fluid communication with the filter to exhaust contents of the filter out of the device, and wherein the end cap further includes an outlet shield positioned to surround the outlet, the outlet shield dimensioned to extend beyond the stent so as to shield the stent against inadvertent contact by a user.

17. The device of 16, wherein the pores have diameters of about 2 micrometers.

20. A blood sampling device comprising:

a hollow fluid tight tube having an inlet end defining an inlet chamber and an outlet end; and

a hollow fiber filter extending within and along a length of the tube, the filter being sealed at a first end thereof proximate to the inlet end and in fluid communication with the outlet end at a second end thereof, wherein

the filter has a hollow interior and includes a plurality of pores sized so as to limit the passage of blood constituents from the inlet chamber to the interior of the filter and to provide passage of blood plasma into the interior of the filter, and

the outlet end is distal to the inlet end and provides fluid exhaust from the interior of the filter.

21. A blood sampling device comprising:

a hollow fluid tight tube having an inlet end defining an inlet chamber and an outlet end, wherein the outlet end provides fluid exhaust from the interior of the tube and includes an end cap for providing a fluid tight seal of the outlet end, the end cap including a hollow stent extending from between the interior and exterior of the tube at the outlet end; and

a hollow fiber filter extending within and along a length of the tube, the filter being sealed at a first end thereof proximate to the inlet end and in fluid communication with the outlet end at a second end thereof, wherein

the filter has a hollow interior and includes a plurality of pores sized so as to limit the passage of blood constituents from the inlet chamber to the interior of the filter and to provide passage of blood plasma into the interior of the filter.

22. The device of claim 21, wherein the fiber filter is mounted to the stent in a fluid tight seal fashion so as to provide a blood plasma exhaust path from the interior of the filter.

23. The device of claim 21, wherein the end cap includes an outlet shield positioned to surround the outlet, the outlet shield dimensioned to extend beyond the stent so as to shield the stent against inadvertent contact.

24. A blood sampling device comprising:

a hollow fluid tight tube having (i) an inlet end defining an inlet chamber, the inlet end including a sharp projection adapted for piercing the skin of a patient, and (ii) an outlet end, the outlet end providing fluid exhaust from the interior of the tube; and

a hollow fiber filter extending within and along a length of the tube, the filter being sealed at a first end thereof proximate to the inlet end and in fluid communication with the outlet end at a second end thereof, wherein

the filter includes a plurality of pores sized so as to limit the passage of blood constituents from the inlet chamber to the interior of the filter and to provide passage of blood into the interior of the filter.

25. A blood sampling device comprising:

a hollow fluid tight tube having an inlet defining an inlet chamber for receiving blood to be sampled and an outlet, the outlet end providing fluid exhaust from the interior of the tube, said inlet chamber defining (a) an inlet chamber wall having a wettable surface; and

(b) a cross sectional area dimensioned such that the inlet chamber is self filling under the influence of capillary action;

a hollow stent extending from between the interior and exterior of the tube at the outlet thereof; and

a hollow blood separation filter positioned within the tube and adapted to separate blood elements from the blood and exhaust such separated blood elements through the hollow stent at the outlet of the tube.

26. A blood sampling device comprising:

a hollow fluid tight tube having an inlet defining an inlet chamber for receiving blood to be sampled and an outlet; and

a blood separation filter positioned within the tube and adapted to separate blood elements from the blood and exhaust such separated blood elements through the outlet of the tube, wherein

(a) the separation filter comprises a hollow elongated fiber filter sealed at one end and coupled to the outlet at the other end, the filter having a plurality of pores to provide a pssageway for blood elements from the inlet chamber to the interior of the filter;

(b) the outlet provides fluid exhaust from the interior of the tube and includes an end cap for providing a fluid tight seal of the outlet, the end cap including a hollow stent extending from between the interior and exterior of the tube at the outlet thereof, the stent in fluid communication with the filter to exhaust contents of the filter out of the device, and wherein the end cap further includes an outlet shield positioned to surround the outlet, the outlet shield dimensioned to extend beyond the stent so as to shield the stent against inadvertent contact by a user; and

wherein

(c) said inlet chamber defines (i) an inlet chamber wall having a wettable surface; and

(ii) a cross sectional area dimensioned such that the inlet chamber is self filling under the influence of capillary action.

27. A blood sampling device comprising:

a hollow fluid tight tube having (a) an inlet defining an inlet chamber for receiving blood to be sampled and including a sharp projection adapted for piercing the skin of a patient, and (b) an outlet, the outlet providing fluid exhaust from the interior of the tube, wherein said inlet chamber defines (i) an inlet chamber wall having a wettable surface; and

(ii) a cross sectional area dimensioned such that the inlet chamber is self filling under the influence of capillary action; and

a blood separation filter positioned within the tube and adapted to separate blood elements from the blood and exhaust such separated blood elements through the outlet of the tube.