METHOD AND APPARATUS FOR PRESERVING URINE SPECIMENS AT ROOM TEMPERATURE

• US 20060024838A1
• Filed: 09/06/2005
• Published: 02/02/2006
• Est. Priority Date: 12/31/2002
• Status: Abandoned Application

• Current Assignee: Stockwell Scientific Inc.
• Original Assignee: Stockwell Scientific Inc.
• Inventors: Leaman, Donald H. Jr.
• Application Number:
  US11/162,320
• Publication Number:
  US 20060024838A1
• Time in Patent Office: Days
• US Class Current: 436/176
• 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: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/12 Specific details about materials
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: B29C 45/0013 using fillers dispersed in the moulding material, e.g. metal particles
• CPC Class Codes: B29K 2105/0011 Biocides
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

A method and apparatus for preserving urine specimens at room temperature for testing includes a container which is made of a plastic and an antimicrobial where the plastic and antimicrobial form a uniform composition throughout the entire mass of the container by simultaneously injection molding the plastic and antimicrobial to form the container. The container preferably has a test tube shape with triclosan as the preferable antimicrobial.

Claims

1. A device for maintaining stabilization of a urine specimen at room temperature for urine transport which comprises a plastic molded container that is simultaneously injection molded with both a plastic and a hydrophobic antimicrobial wherein the plastic molded container is configured to limit a ratio of urine volume to be contained in the container to an interior surface of the container to a value less than one and where the container maintains the presence and concentration of diagnostic markers contained within the urine.

2. The device of claim 1 wherein said antimicrobial comprises at least one of triclosan, zinc pyrithione, 3-ido-2-propynyl butyl carbamate, silver compounds and organotin compounds.

3. The device of claim 1 wherein said plastic comprises at least one of a polypropylene copolymer, a polystyrene, a styrene butadiene copolymer, a clarified polypropylene, a polycarbonate, and an acrylic.

4. The device of claim 2 wherein the antimicrobial is within a range of about 0.01 to 0.80% by weight.

5. The device of claim 3 wherein the plastic preferably comprises a polypropylene copolymer or polystyrene within a range of about 99.2 to 99.99% by weight.

6. The device of claim 1 wherein said container comprises at least one of a tube shape, a bottle shape, a cuvette shape, and a vial shape.

7. The device of claim 1 wherein less than about 0.02% of said antimicrobial exposed to the urine specimen is leached into the urine specimen over a time period of 72 hours.

8. The device of claim 1 wherein said device is capable of preserving the urine specimen at room temperature for at least one of storage and transport for urinalysis for up to about 72 hours.

9. The device of claim 1 wherein said antimicrobial is uniformly distributed on both a surface area of said container and throughout a mass of said container.

10. The device of claim 1 wherein said container prevents intrinsic growth of microbes which would alter the composition of the urine specimen.

11. The device of claim 1 wherein said container prevents growth of microbes, without adding solids to the container, which could alter a specific gravity of the urine specimen.

12. The device of claim 1 wherein said container prevents intact cells contained in the urine specimen from being degraded by micro-organisms.

13. A device for maintaining stabilization of a urine specimen at room temperature for culturing at least one of a bacteria and a fungus common to the urinary tract which comprises a plastic injection molded container that is simultaneously injection molded with both a plastic and a hydrophobic antimicrobial wherein the plastic injection molded container is configured to limit a ratio of urine volume to be contained in the container to an interior surface of the container to a value less than one and where the device maintains the presence and concentration of diagnostic markers and intact cells contained within the urine.

14. The device of claim 13 wherein said antimicrobial comprises at least one of triclosan, zinc pyrithione, 3-ido-2-propynyl butyl carbamate, silver compounds and organotin compounds.

15. The device of claim 13 wherein said plastic comprises at least one of a polypropylene copolymer, a polystyrene, a styrene butadiene copolymer, a clarified polypropylene, a polycarbonate, and an acrylic.

16. The device of claim 14 wherein the antimicrobial is within a range of about 0.01 to 0.5% by weight.

17. The device of claim 16 wherein the plastic preferably comprises a polypropylene copolymer or polystyrene within a range of about 99.5 to 99.99% by weight.

18. The device of claim 13 wherein said container comprises at least one of a tube shape, a bottle shape, a cuvette shape, and a vial shape.

19. The device of claim 13 wherein less than about 0.02% of said antimicrobial exposed to the urine specimen is leached into the urine specimen over a time period of 72 hours.

20. The device of claim 13 wherein said device is capable of preserving the urine specimen at room temperature for at least one of storage and transport for culture and identification for up to about 72 hours.

21. The device of claim 13 wherein said antimicrobial is uniformly distributed on both a surface area of said container and throughout a mass of said container.

22. The device of claim 13 wherein said container limits the growth of microbes intrinsic to the urine specimen to prevent their loss due to overgrowth before they can be cultured.

23. A container for preserving a urine test specimen at room temperature comprising:

a plastic within a range of about 99.5 to 99.99% by weight; and

a hydrophobic antimocrobial within a range of about 0.01 to 0.80% by weight, wherein said plastic and said hydrophobic antimicrobial are mixed together either before or during injection molding to form a container in the shape of a test tube such that a concentration of diagnostic markers contained in a urine specimen placed in the test tube remains constant.

24. The container of claim 23 wherein said antimicrobial comprises at least one of triclosan, zinc pyrithione, 3-ido-2-propynyl butyl carbamate, silver compounds and organotin compounds.

25. The container of claim 23 wherein said plastic comprises at least one of a polypropylene copolymer, a polystyrene, a styrene butadiene copolymer, a clarified polypropylene, a polycarbonate, and an acrylic.

26. The container of claim 23 wherein the antimicrobial is within a range of about 0.1 to 0.3% by weight.

27. The container of claim 26 wherein the plastic preferably comprises a polypropylene copolymer or polystyrene within a range of about 99.5 to 99.9% by weight.

28. The container of claim 23 wherein less than about 0.02% of said antimicrobial exposed to the urine specimen is leached into the urine specimen over a time period of 72 hours.

29. The container of claim 23 further comprising a friction fit cap.

30. The container of claim 23 wherein said antimicrobial is uniformly distributed on both a surface area of said container and throughout a mass of said container.

31. The container of claim 23 wherein said container prevents intrinsic growth of microbes which would alter the composition or specific gravity of the urine specimen.

32. A method for making a urine transport and storage container which preserves a urine sample for testing comprising the steps of:

selecting a plastic material;

selecting a hydrophobic antimicrobial material;

blending said antimicrobial material into said plastic material during injection molding to form a container having an interior surface area; and

configuring the container to limit a ratio of a urine volume to be contained within the container to the interior surface area of the container to a value less than one and wherein a concentration of diagnostic markers in a the urine volume sample contained in the container remains constant during transport and storage.

33. The method of claim 33 wherein said step of selecting a plastic material comprises the step of selecting at least one of a polypropylene copolymer, a polystyrene, a styrene butadiene copolymer, a clarified polypropylene, a polycarbonate, and an acrylic.

34. The method of claim 33 wherein said step of selecting an antimicrobial comprises the step of selecting at least one of triclosan, zinc pyrithione, 3-ido-2-propynyl butyl carbamate, silver compounds and organotin compounds.

35. The method of claim 33 wherein said step of injection molding comprises the step of forming container having at least one of a tube shape, a bottle shape, a cuvette shape, and a vial shape.

36. The method of claim 33 wherein said container comprises a polypropylene copolymer within about 99.2 to 99.99% by weight and triclosan within about 0.01 to 0.80% by weight.

37. A method for making a urine transport and storage container for preserving a urine specimen at room temperature for testing comprising the steps of:

mixing a plastic and a hydrophobic antimicrobial to form a mixture; and

injection molding said mixture to form a container having an interior surface area; and

configuring the container to limit a ratio of a urine volume to be contained within the container to the interior surface area of the container to a value less than one and where a concentration of diagnostic markers in the urine volume specimen contained in the container remains constant.

38. The method of claim 38 wherein said step of mixing a plastic and an antimicrobial further comprises the step of selecting a plastic from at least one of a polypropylene copolymer, and a polystyrene, a styrene butadiene copolymer, a clarified polypropylene, a polycarbonate, and an acrylic.

39. The method of claim 38 wherein said step of mixing a plastic and an antimicrobial further compromises the step of selecting an antimicrobial from at least one of triclosan, zinc pyrithione, 3-ido-2-propynyl butyl carbamate, silver compounds and organotin compounds.

40. The method of claim 38 wherein said container comprises a polypropylene copolymer within about 99.92 to 99.99% by weight and triclosan within about 0.01 to 0.80% by weight.

41. A device for maintaining stabilization of a urine specimen at room temperature for urine transport comprising a device having a hydrophobic anitimicrobial uniformly distributed throughout a mass of the device wherein the antimicrobial uniformity enables stabilization of a concentration of diagnostic markers contained in urine specimens having a volume within a range of about 1 milliliter to about 8 milliliters that are contained within the device.