Integrated body fluid collection and analysis device with sample transfer component

• US 6,372,182 B1
• Filed: 12/15/1999
• Issued: 04/16/2002
• Est. Priority Date: 05/01/1998
• Status: Active Grant

• Current Assignee: Aalto Scientific Ltd.
• Original Assignee: Aalto Scientific Ltd.
• Inventors: Reynolds, Robert A., Mauro, Stephen F.
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US09/461,989
• Time in Patent Office: 853 Days
• Field of Search: 422/55, 422/56, 422/57, 422/58, 422/61, 422/100, 422/102, 604/318, 604/408, 604/409, 600/584
• US Class Current: 422/417
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61M 1/69 Drainage containers not being adapted for subjection to vacuum, e.g. bags devices worn by the patient for reception of urine A61F5/44
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0605 check valves
• 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 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 1/4077 by other techniques involving separation of suspended solids

Abstract

A single, integrated device in which a body fluid (e.g., blood) of a human or animal can be both collected and analyzed easily and without risk of contamination is disclosed. The collection portion and analysis portion of the device are permanently joined to permit movement of small quantities of body fluid under controlled conditions, to minimize any waste of the body fluid, to ensure that no contamination reaches the main body fluid volume, and to create a permanent physical record of the results of the analysis in association with the fluid sample itself: A wide variety of different body fluid components which may be indicative of various diseases, dysfunctions and abnormalities of the human or animal or the body fluid itself can be tested for. The device includes a container for collecting human or animal body fluid, one or more testing chambers containing one or more analysis units activated by body fluid; a transfer pump or vacuum assembly to transfer one or more samples into the analysis units; and one-way valves or the equivalent to prevent any portion of the withdrawn sample from being returned to the collection container. The body fluid acted upon may be blood, blood plasma, urine, bile, pleural fluid, ascites fluid, stomach or intestine fluid, colostrom, milk or lymph.

Claims

1. An integrated body fluid collection and analysis device for analysis of a body fluid comprising:

a body fluid reservoir;

a body fluid-activated analysis unit permanently associated therewith;

a fluid conduit between said reservoir and said analysis unit for passage of said body fluid from said reservoir to said analysis unit;

transfer means for transferring said body fluid from said reservoir to said analysis unit through said fluid conduit; and

a backflow restrictor in said fluid conduit;

such that no portion of body fluid transferred by said pump from said reservoir to said analysis unit returns to said reservoir.

2. A device as in claim 1 wherein said transfer means is disposed in said fluid conduit.

3. A device as in claim 2 wherein said backflow restrictor is disposed between said transfer means and said reservoir.

4. A device as in claim 2 wherein said backflow restrictor is disposed between said transfer means and said analysis unit.

5. A device as in claim 1 wherein said transfer means is disposed in fluid communication with an end of said analysis unit distal from said reservoir.

6. A device as in claim 1 wherein said transfer means is manually operated.

7. A device as in claim 6 wherein said transfer means comprises a chamber enclosed by a flexible wall and is operated by manual compression of said flexible wall when said body fluid is present in said chamber.

8. A device as in claim 1 wherein said transfer means comprises a mechanical or electromechanical pump or a vacuum fluid drawing assembly.

9. A device as in claim 1 wherein said body fluid acted upon comprises blood, blood plasma, urine, bile, stomach or intestine fluid, colostrom, milk or lymph.

10. A device as in claim 1 wherein said analysis unit comprises detection means for detecting and indicating the presence or absence in said body fluid of a component of said body fluid, said presence or absence being indicative of disease, abnormality or dysfunction of a human or animal from which said body fluid was obtained.

11. A device as in claim 10 wherein said analysis unit comprises a plurality of detection means, each said detection means of said plurality for detecting the presence or absence in said body fluid of a different component of said body fluid each indicative of disease, abnormality or dysfunction of said human or animal from which said body fluid was obtained.

12. A device as in claim 10 wherein said analysis unit further comprises a first control detector providing confirmation that said body fluid transferred by said transfer means has entirely filled said analysis unit.

13. A device as in claim 10 wherein said detection means comprises a chamber having therein a material sensitive to the presence of said component of said body fluid, activation of said material by said component in said body fluid causing by a visible change in the appearance of said material, said chamber being enclosed by a wall which comprises a viewing area though which said visible change may be observed, such that said detection means manifests identification of said presence or absence of said component by the appearance or non-appearance of said visible change within said viewing area.

14. A device as in claim 13 wherein said material is disposed within said chamber in a distinctive pattern and said visible change comprises appearance of color or change of color in said material in said pattern.

15. A device as in claim 11 wherein each said detection means in said plurality comprises a chamber having therein a material sensitive to the presence of said component of said body fluid for which said detection means is directed, activation of said material by said component in said body fluid causing by a visible change in the appearance of said material, said chamber being enclosed by a wall which comprises a viewing area though which said visible change may be observed, such that said detection means manifests identification of said presence or absence of said component by the appearance or non-appearance of said visible change within said viewing area.

16. A device as in claim 15 wherein in each said detection means said material is disposed within said chamber in a distinctive pattern and said visible change comprises appearance of color or change of color in said material in said pattern.

17. A device as in claim 12 wherein said control detector comprises a chamber having therein a material sensitive to the presence of said body fluid, activation of said material by said body fluid causing by a visible change in the appearance of said material, said chamber being enclosed by a wall which comprises a viewing area though which said visible change may be observed, such that said detection means manifests confirmation that said body fluid has reached said control detector by the appearance or non-appearance of said visible change within said viewing area.

18. A device as in claim 17 wherein said material is disposed within said chamber in a distinctive pattern and said visible change comprises appearance of color or change of color in said material in said pattern.

19. A device as in claim 10 wherein said analysis unit further comprises a second control detector comprising a reactant which reacts with said body fluid in a known manner and provides an indication confirming such known reaction, said indication providing confirmation of the nature of said bodily fluid.

20. A device as in claim 19 further comprising a first control detector providing confirmation that said body fluid transferred by said transfer means has entirely filled said analysis unit.

21. A device as in claim 20 wherein said first control detector and said second control detector comprise a single unitary control detector which provides confirming functions of both said first control detector and said second control detector.