Nonintrusive body fluid samplers and methods of using same

• US 4,635,488 A
• Filed: 12/03/1984
• Issued: 01/13/1987
• Est. Priority Date: 12/03/1984
• Status: Expired due to Fees

• Current Assignee: Schleicher & Schuell Inc.
• Original Assignee: Schleicher & Schuell Inc.
• Inventors: Kremer, Richard D.
• Primary Examiner(s): Tokar, Michael J.
• Assistant Examiner(s): Noland, Tom
• Application Number:
  US06/677,226
• Time in Patent Office: 771 Days
• Field of Search: 73/864.72, 73/863, 73/61.1 C, 128/760, 128/771, 604/1, 604/312, 604/318, 604/364, 604/358, 604/365, 604/366, 604/367, 604/370, 604/374, 604/375, 422/56, 422/58, 422/59, 422/61, 422/69, 422/70, 436/165, 436/169, 436/174, 436/179, 436/180, 116/206
• US Class Current: 73/864.72
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 2010/0067 Tear or lachrymal fluid
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0457 passive flow or gravitation
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 1/10 in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 2001/149 Capillaries; Sponges
• CPC Class Codes: G01N 33/487 of liquid biological material

Abstract

A body fluid sampling device including a hollow tube with a solid, porous, water-wettable nonfibrous nib mounted in and protruding from one end of the tube for collecting, by absorption, a sample of a body fluid such as sweat, tears, or saliva. The sample may be extracted from the nib for analysis by supplying an extraction fluid to the interior of the tube for gravity or vacuum-assisted flow out through the nib. Alternatively, an elongated analysis element such as a strip of paper or a packed column, e.g. containing an agent that changes appearance to indicate the presence of a substance to be detected, may be disposed in the tube for endwise contact with the nib to receive the sample (or components thereof) by absorption.

Claims

1. A device for nonintrusively collecting a sample of a fluid such as sweat, tears or saliva, comprising:

(a) a hollow tube having at least one open end; and

(b) a collecting nib secured in said one end of said tube and having an inner extremity facing the interior of the tube and an outer tip projecting beyond said one end of the tube for contact with a fluid to be collected, said nib comprising a solid, nonfibrous, porous, water-wettable body a porosity sufficient for absorption therein of the fluid to be collected, and said nib and said one end of said tube being mutually arranged to permit passage of fluid between the exterior and the interior of the tube at said one end only through the nib body.

2. A device as defined in claim 1, wherein said tube has a second open end opposed to said one open end.

3. A device as defined in claim 2, further including a cap for closing said second open end of the tube.

4. A device as defined in claim 3, further including a second cap for externally enclosing the nib and said one open end of said tube.

5. A device as defined in claim 1, wherein the nib body is fabricated of a material selected from the class consisting of polyethylene and polypropylene.

6. A device as defined in claim 1, wherein the nib body and the tube are bonded together by ultrasonic welding at said one end of the tube.

7. A device as defined in claim 1, wherein the nib body is press-fitted into said one end of the tube.

8. A device as defined in claim 1, wherein the nib body and the tube are joined by heat sealing.

9. A device as defined in claim 1, wherein said nib tip is substantially pointed.

10. A device as defined in claim 1, wherein said nib tip is substantially rounded.

11. A device as defined in claim 1, wherein said nib incorporates an agent capable of changing color on contact with a substance to be detected.

12. A device as defined in claim 1, wherein said tube is formed with an external annular ledge facing said one end to serve as a bearing surface for support of the tube in upright position with the nib oriented downwardly.

13. A device as defined in claim 1, wherein said tube has a second open end opposed to said one open end, and further including a cap for closing said second open end, and an elongated, absorbent, substantially rigid analysis element extending through the tube for fluid-transferring contact with the inner extremity of the nib to receive and absorb fluid collected by the nib;

and wherein said analysis element has a proximal end mounted in said cap and a distal end disposed for contact with said nib inner extremity when said cap is in position closing said second open end.

14. A device as defined in claim 13, wherein said analysis element comprises a strip of web material having a distal end secured to said nib.

15. A device as defined in claim 13, wherein said analysis element comprises a strip of web material, and, mounted at the distal end thereof, a porous absorbent solid body disposed for fluid-transferring contact with the inner extremity of the nib.

16. A device as defined in claim 15, wherein said last-mentioned body is hydrophobic.

17. A device as defined in claim 13, wherein said analysis element comprises a packed column having a distal end secured to said nib.

18. A device as defined in claim 13, wherein said analysis element comprises a packed column and, mounted at the distal end thereof, a porous absorbent solid body disposed for fluid-transferring contact with the inner extremity of the nib.

19. A device as defined in claim 18, wherein said last-mentioned body is hydrophobic.

20. A device as defined in claim 13, wherein said analysis element incorporates an agent which undergoes an observable change upon contact with a substance to be detected, and wherein said tube is transparent.

21. A device as defined in claim 1, wherein said tube has a second open end opposed to said one open end, and further including a cap for closing said second open end, and a packed columm of particules filling said tube and in fluid-transferring contact with the inner extremity of said nib, said particules comprising an agent which undergoes an observable change upon contact with a substance to be detected.

22. A device as defined in claim 1, wherein said tube has a second open end opposed to said one open end, and further including a cap for closing said second open end, a porous absorbent hydrophobic solid body disposed within the tube in fluid-transferring contact with the inner extremity of the nib, and a packed column of particles filing said tube and in fluid-transmitting contact with said hydrophobic solid body, said particles comprising an agent which undergoes an observable change upon contact, or subsequent development, with a substance to be detected.

23. A device as defined in claim 1, wherein said tube is shaped and dimensioned for insertion in the human mouth with said tip positioned under the tongue for collection of a sample of saliva.