Biological fluid sampling and storage apparatus for remote use

• US 9,040,236 B2
• Filed: 07/25/2011
• Issued: 05/26/2015
• Est. Priority Date: 08/26/2010
• Status: Active Grant

• Current Assignee: Spot Bioscience, LLC
• Original Assignee: Spot On Sciences, Inc.
• Inventors: Hill, Jeanette, Hill, James
• Primary Examiner(s): FORMAN, BETTY J
• Application Number:
  US13/817,442
• Publication Number:
  US 20130143226A1
• Time in Patent Office: 1,401 Days
• Field of Search: None
• US Class Current: 435/6.1
• 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 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/0067 Tear or lachrymal fluid
• CPC Class Codes: A61B 2010/0077 Cerebrospinal fluid
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15101 Details
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• 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: Y10T 436/25 including sample preparation

Abstract

An apparatus for sampling and storing biological fluids from a human or animal subject is provided. In one embodiment of the present disclosure, the apparatus includes a main body, lancet carrier or hub, lancet, lancet trigger, capillary tube, and sample compartments for collecting and storing dried blood and other bodily fluids. The lancet hub supports a lancet and provides for moving the lancet longitudinally between a first retracted position and a second extended position. The device includes a capillary tube having an internal diameter sized to draw and retain fluid from a contacted source using capillary action. The main body of the apparatus further includes a sample compartment for holding sampling and storage materials. In at least one embodiment of the present disclosure, the sample compartment can be accessed by lifting sample compartment lid. Also included is a new “fan” or “daisy” shaped collection material format for use in collecting and preserving samples.

Claims

1. A sampling and storage device for biological fluids comprising:

a body comprising;

two or more structural components that can at least partially be attached and detached from one another and can form an open and a closed configuration, having a top portion and a bottom portion in the closed configuration, wherein the components form one or more interior cavities when in the closed configuration;

a carrier that is disposed on the top surface of the top portion, wherein the carrier extends from one edge of the body to the opposing edge and comprises a channel;

a capillary tube contained in the channel of the carrier and extending from an exterior of the device to a fluid reservoir and in fluid communication with the one or more interior cavities;

one or more collection compartments formed in the one or more interior cavities and in fluid communication with the capillary tube;

one or more pieces of sampling material placed within the one or more collection compartments and in fluid communication with the capillary tube; and

a desiccant contained within the cavities in vaporous communication with the sampling material, and suitable for drying a collected sample and maintaining low humidity in the device; and

a mechanism for sealing the device from the environment after use.

2. The device of claim 1, wherein the sampling material is a solid support comprising nylon, polypropylene, polyester, rayon, cellulose, cellulose acetate, mixed cellulose ester, glass microfiber filter, cotton, quartz microfiber, polytetrafluoroethylene, polyvinylidene fluoride, filter paper or a combination of any thereof, or one or more sheets of absorbent material.

3. The device of claim 1, wherein the sampling material, the capillary tube or both comprise an anticoagulant.

4. The device of claim 1, wherein the sampling material comprises a detergent, a chelator, a pH modulating chemical, an enzyme inhibitor, a denaturant, or a combination thereof.

5. The device of claim 1, wherein the biological fluid is whole blood, plasma, serum, urine, saliva, cerebrospinal fluid, a tissue culture supernatant, bronchoalveolar lavage, synovial fluid, a tissue extract, tear, or a skin washing.

6. The device of claim 1, further comprising one or more identification mechanisms.

7. The device of claim 6, wherein the identification mechanism is one or more bar code tags, one or more RFID tags or a combination thereof affixed to the device.

8. The device of claim 1, further comprising one or more identification mechanisms attached to the sampling material.

9. The device of claim 8, wherein the identification mechanisms are one or more barcode tags, RFID tags, or a combination thereof.

10. The device of claim 1 wherein the sealing mechanism is selected from a sticker placed over the outside opening of the capillary tube, a plug placed within the capillary tube, a movable door or slide that can be positioned to cover the capillary opening, pinching or twisting the capillary tube so that it is sealed, and replacing the capillary tube containing structural component with a structural component not containing a capillary tube.

11. The device of claim 1 further comprising a lancet device within the channel of the carrier that is effective to cause a small wound in the subject to create a blood flow for collection in the device.

12. The device of claim 1 wherein the sampling material comprises a central disk from which radiates a plurality of protrusions, wherein each protrusion contacts only the central disk and does not contact any other protrusion, and wherein the plurality of protrusions and central disk substantially define a fan-shape.

13. A method of sampling and storing a biological fluid from a subject for testing comprising:

contacting a biological fluid of the subject with the end of the capillary tube of the device of claim 1 effective to draw the biological fluid into the one or more interior cavities and into contact with the sampling material;

drying the biological fluid absorbed into the sampling material; and

storing the dried biological material in the device.

14. The method of claim 13, further comprising shipping the device containing the dried biological sample to a location remote from the collection site for testing.

15. The method of claim 13 wherein the sampling material is removed from the device for testing.

16. The method of claim 13, wherein at least a portion of the sampling material comprises a chemical test reagent that reacts to a characteristic or component of a biological fluid.

17. The method of claim 16 wherein the reaction results in a color change.