Disposable test vial with sample delivery device for dispensing sample into a reagent

• US 6,319,209 B1
• Filed: 08/23/1999
• Issued: 11/20/2001
• Est. Priority Date: 08/23/1999
• Status: Expired due to Term

• Current Assignee: LifeAssays AB
• Original Assignee: European Institute of Science AB
• Inventors: Kriz, Dario
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/379,158
• Time in Patent Office: 820 Days
• Field of Search: 600/562, 600/564, 600/569, 600/570, 600/572, 600/573, 600/576, 600/583, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 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 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures

Abstract

A disposable body fluid or tissue collection vial is disclosed. The vial has a sample accessing tool and a sample delivery member for dispensing a sample of body fluid or tissue into a reagent. The vial also has a base, a sample delivery sleeve, a sample accessing sleeve, and a cap. The sample delivery sleeve detachably attaches to the base, the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve. The base may contain one or more reagents suitable for diagnostic or other uses.

Claims

1. A vial for testing a sample, comprising:

a base, a reversible sample delivery sleeve comprising a sample delivery member, a sample accessing sleeve, and a cap, wherein the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve, and wherein the sample delivery sleeve detachably attaches to the base in a first and a second orientation, wherein in the first orientation the sample delivery member extends away from the base, and wherein in the second orientation the sample delivery member is positioned within the base.

2. The vial of claim 1, wherein the sample accessing sleeve comprises a sample accessing tool.

3. The vial of claim 2 wherein the sample accessing tool is a lancet.

4. The vial of claim 3, wherein the sample delivery member is a capillary tube.

5. The vial of claim 1, further comprising a reagent within the base.

6. The vial of claim 5 wherein the reagent comprises one or more of the group consisting of a solvent, a buffer, an anticoagulant, an antibody, an enzyme, a dye, a growth nutrient, a marker, and a separation particle.

7. The vial of claim 6 wherein the reagent further comprises a ferromagnetic substance.

8. The vial of claim 1, further comprising at least one additive within the base.

9. The vial of claim 8 wherein the additive is selected from the group consisting of sepharose, sephadex, cellulose, sephacryl, acrylic beads, plastic, polycarbonate, polytetrafluoroethylene, glass, polystyrene, polyethylene, polyvinyl, protein, starch, glycogen, chitosan, silica, zeolite, magnetic particles, and diatomaceous earth.

10. The vial of claim 1, wherein the base is constructed of a material comprising at least one member selected from the group consisting of polyethylene, polypropylene, polystyrene, TEFLON®

, polycarbonate, polymethylpentene, TEFZEL®

, polytetrafluoroethylene, quartz and glass.

11. A method for analyzing a sample, comprising the steps of:

providing a vial for testing a sample, the vial comprising a base, a reversible sample delivery sleeve comprising a sample delivery member, a sample accessing sleeve, and a cap, wherein the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve, and wherein the sample delivery sleeve detachably attaches to the base in a first and a second orientation, wherein in the first orientation the sample delivery member extends away from the base, and wherein in the second orientation the sample delivery member is positioned within the base;

contacting a material comprising the sample with the sample delivery member to retrieve the sample with the sample delivery member;

delivering the sample from the sample delivery member to the base; and

analyzing the sample contained within the base.

12. The method of claim 11, wherein the sample comprises body fluid.

13. The method of claim 11, wherein the sample comprises body tissue.

14. The method of claim 11, wherein the base contains a reagent, and wherein the delivering step comprises contacting the sample delivery member with the reagent.

15. The method of claim 14 wherein the reagent comprises one or more of the group consisting of a solvent, a buffer, an anticoagulant, an antibody, an enzyme, a dye, a growth nutrient, a marker, and a separation particle.

16. The method of claim 15, wherein the reagent further comprises a ferromagnetic substance.

17. The method of claim 11 wherein the delivering step comprises rotating the sample delivery sleeve from a first position, in which the sample delivery member does not contact the reagent, into a second position, in which the sample delivery member contacts the reagent.

18. The method of claim 17 wherein said sample delivery sleeve attaches to the base in both said first position and said second position.