Devices, systems, and methods for the collection of body fluids

• US 8,932,234 B2
• Filed: 10/11/2011
• Issued: 01/13/2015
• Est. Priority Date: 10/11/2010
• Status: Active Grant

• Current Assignee: Bioanalytical Systems, Inc.
• Original Assignee: Bioanalytical Systems, Inc.
• Inventors: Peters, Scott R., Hampsch, James M.
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US13/270,902
• Publication Number:
  US 20120088250A1
• Time in Patent Office: 1,190 Days
• Field of Search: 738/63, 738/633.3, 738/649.1, 206/569, 206/570, 206/461, 206/462, 206/464, 206/467, 206/231, 206/775, 206/781, 422/420, 422/548, 422/551, 422/552, 422/939, 4352877-2879, 600/573, 600/575, 604/6.15, 604/403
• US Class Current: 600/575
• 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 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: B01L 2300/0803 Disc shape
• CPC Class Codes: B01L 2300/0806 Standardised forms, e.g. compact disc [CD] format
• CPC Class Codes: B01L 3/50 Containers for the purpose of retaining a material to be analysed, e.g. test tubes devices for taking samples of blood A61B5/15
• CPC Class Codes: B01L 3/5085 for multiple samples, e.g. microtitration plates
• CPC Class Codes: B01L 3/50853 with covers or lids
• CPC Class Codes: G01N 1/2813 Producing thin layers of samples on a substrate, e.g. smearing, spinning-on G01N1/30 takes precedence
• CPC Class Codes: G01N 1/30 Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
• CPC Class Codes: G01N 2001/2826 Collecting by adsorption or absorption
• CPC Class Codes: G01N 2001/288 Filter punches
• CPC Class Codes: G01N 35/00069 whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

Devices, systems, and methods for the collection of biological samples. In at least one exemplary embodiment, a device comprises a collection medium having top and bottom surfaces and a predetermined size and shape, the top surface comprising a position marker and at least one binding site operable to bind a biological sample, a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium. The protective facing being sized and shaped to define a first void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, and a second void positioned to expose the position marker for alignment of the collection medium.

Claims

1. A storage device for biological samples, the device comprising:

a collection medium having a predetermined size and shape, the collection medium comprising;

a top surface;

a bottom surface;

a position marker positioned proximate to an edge of the collection medium, wherein the position marker is a void containing no collection medium;

a first central void extending through the center of the collection medium;

at least one first alignment void; and

at least one binding site operable to bind a biological sample;

a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium, the protective facing including;

a second central void in the middle of the protective facing, the second central void structured and positioned so as to align with the first central void; and

at least one second alignment void structured and positioned so as to respectively align with the at least one first alignment void in the collection medium;

wherein the protective facing is sized and shaped to define a first facing void and a second facing void, the first facing void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, the second facing void positioned to expose the position marker.

2. The storage device of claim 1, wherein the at least one binding site is positioned proximate to the edge of the collection medium.

3. The storage device of claim 1, wherein the at least one binding site comprises a plurality of binding sites each positioned in a row along the edge of the collection medium.

4. The storage device of claim 1, where the collection medium further comprises a separation element operable to divide the collection medium into at least two predetermined portions.

5. The storage device of claim 4, wherein the separation element is a perforation capable of separating the collection medium into the at least two predetermined portions upon exertion of a force.

6. The storage device of claim 4, wherein the separation element is positioned so as to divide the collection medium into the at least two predetermined portions through the position marker.

7. The storage device of claim 1, wherein the biological sample is selected from the group consisting of blood, blood fractions, sweat, urine, tears and cerebral spinal fluid, or combinations thereof.

8. The storage device of claim 1, wherein the collection medium is substantially circular.

9. The storage device of claim 1, further comprising an identification marker coupled to the protective facing.

10. The storage device of claim 1, wherein the at least one first alignment void and the at least one second alignment void are structured and positioned so as to allow the passage of an alignment member.

11. The storage device of claim 10, further comprising the alignment member traversing both the at least one first alignment void and the at least one second alignment void, and securing the collection medium to the protective facing.

12. The storage device of claim 1, wherein the protective facing comprises a coupling member and the protective facing is shaped to define a coupling void capable of engaging the coupling member.

13. The storage device of claim 12, wherein the protective facing comprises a top facing and a bottom facing, the top facing shaped to define the coupling void and the bottom facing defining the coupling member;

wherein when the collection medium is placed between the top facing and bottom facing, and the coupling void engages the coupling member, the collection medium is securably engaged to the protective facing.

14. The storage device of claim 1, wherein the protective facing is coupled to a bottom surface of the collection medium.

15. The storage device of claim 1, wherein the storage device is sized and shaped to define at least one third alignment void operable for engaging a sample collection apparatus.

16. A system for the storage of biological samples, the system comprising:

a biological sample collection apparatus capable of collecting a biological sample from a subject; and

a storage device capable of receiving the biological sample from the collection apparatus, the storage device comprising;

a collection having a predetermined size and shape, the collection medium comprising;

a top surface;

a bottom surface;

a position marker positioned proximate to an edge of the collection medium, wherein the position marker is a void containing no collection medium;

a first central void extending through the center of the collection medium;

at least one first alignment void; and

at least one binding site operable to bind a biological sample;

a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium, the protective facing including;

a second central void in the middle of the protective facing, the second central void structured and positioned so as to align with the first central void; and

at least one second alignment void structured and positioned so as to respectively align with the at least one first alignment void in the collection medium;

wherein the protective facing is sized and shaped to define a first facing void and a second facing void, the first facing void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, the second facing void positioned to expose the position marker.

17. The system of claim 16, wherein the at least one binding site is positioned proximate to the edge of the collection medium.

18. The system of claim 16, wherein the at least one binding site comprises a plurality of binding sites each positioned in a row along the edge of the collection medium.

19. The system of claim 16, where the collection medium further comprises a separation element operable to divide the collection medium into at least two predetermined portions.

20. The system of claim 19, wherein the separation element is a perforation capable of separating the collection medium into the at least two predetermined portions upon exertion of a force.

21. The system of claim 19, wherein the separation element is positioned so as to divide the collection medium through the position marker.

22. The system of claim 16, wherein the protective facing comprises a coupling member and the protective facing is shaped to define a coupling void capable of engaging the coupling member.

23. The system of claim 22, wherein the protective facing comprises a top facing and a bottom facing, the top facing shaped to define the coupling void and the bottom facing defining the coupling member;

wherein when the collection medium is placed between the top facing and bottom facing, and the coupling void engages the coupling member, the collection medium is securably engaged to the protective facing.