Whole blood sampling device

• US 20030206828A1
• Filed: 05/06/2002
• Published: 11/06/2003
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Bell, Michael L.
• Granted Patent: US 6,755,802 B2
• Time in Patent Office: Days
• US Class Current: 422/44
• 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 2313/20 Specific housing
• CPC Class Codes: B01D 2313/206 characterised by the material
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01D 63/024 with a single potted end
• 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 includes a plurality of pores sized so as to limit the passage of fluids from the inlet chamber to the interior of the filter to blood plasma.

2. The device of claim 1, wherein the outlet end of the tube 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 thereof.

3. The device of claim 2, 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.

4. The device of claim 3, 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.

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

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 5, 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.

8. The device of claim 7 wherein the fiber filter has a cross section smaller than that of the inlet chamber defining thereby a fill volume therebetween.

9. The device of claim 8 wherein the predetermined distance is at a location that corresponds to no more than half of the fill volume.

10. 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.

11. The device of claim 10 wherein the inlet chamber contains an anticoagulant reagent to inhibit clotting.

12. The device of claim 1, wherein the inlet includes a sharp projection adapted for piercing the skin of a patient for drawing blood therefrom.

13. 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.

14. The blood sampling device of claim 13 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 plurality of pores to provide passageways for blood elements from the inlet chamber to the interior of the filter.

15. The blood sampling device of claim 14 wherein the pores are sized to limit the passage of blood elements to blood plasma.

16. 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 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.

17. The device of claim 13, wherein the inlet includes a sharp projection adapted for piercing the skin of a patient for drawing blood therefrom.

18. The device of claim 15, wherein the pores have diameters of about 2 micrometers.

19. The device of claim 15, wherein the pores have diameters in the range of about 0.1 to 1.0 micrometers.