Sampling systems and related materials and methods

• US 10,588,608 B2
• Filed: 08/18/2017
• Issued: 03/17/2020
• Est. Priority Date: 08/18/2016
• Status: Active Grant

• Current Assignee: Progenity, Inc. (Athyrium Capital Management LP)
• Original Assignee: Progenity, Inc. (Athyrium Capital Management LP)
• Inventors: Jones, Mitchell Lawrence, Wahl, Christopher Loren, Philippsen, Aaron Olafur Laurence, Allan, Nicholas David, Drlik, Mark Sasha, McGuinness, Ryan Paul, Singh, Sharat, Magyar, Robert S.
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US15/680,430
• Publication Number:
  US 20180052084A1
• Time in Patent Office: 942 Days
• Field of Search: 600300, 600424, 600573, 600583, 435 79, 435 614
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/088 Channel loops
• CPC Class Codes: B01L 2300/12 Specific details about materials
• CPC Class Codes: B01L 2300/1883 using thermal insulation
• CPC Class Codes: B01L 2400/0472 : Diffusion
• CPC Class Codes: B01L 2400/0475 : specific mechanical means and fluid pressure
• CPC Class Codes: B01L 2400/0633 : with moving parts
• CPC Class Codes: B01L 2400/0677 : phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• 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 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5085 : for multiple samples, e.g. microtitration plates
• CPC Class Codes: G01N 1/405 : by adsorption or absorption
• CPC Class Codes: G01N 33/56916 : Enterobacteria, e.g. shigella, salmonella, klebsiella, serratia
• CPC Class Codes: G01N 33/56938 : Staphylococcus
• CPC Class Codes: G01N 33/56944 : Streptococcus

Abstract

Sampling systems that include an absorbent material a preservative, such as an analyte preservative, as well as related materials and methods, are disclosed.

Claims

1. An ingestible device, comprising:

a sampling system, comprising;

a first absorbent member;

a second absorbent member different from the first absorbent member; and

at least one preservative,

wherein;

the first absorbent member is configured to absorb a fluid,

the sampling system is configured so that fluid that flows from an exterior of the ingestible device to an interior of the ingestible device enters the first absorbent member; and

the sampling system is configured to allow fluid to flow from the first absorbent member to the second absorbent member.

2. The ingestible device of claim 1, wherein the at least one preservative is at least one analyte preservative.

3. The ingestible device of claim 2, wherein the at least one analyte preservative comprises a preservative for at least one of a nucleic acid, a small molecule, or a protein.

4. The ingestible device of claim 2, wherein the at least one analyte preservative comprises a preservative for at least one nucleic acid, small molecule, or protein that is a biomarker of at least one GI disorder.

5. The ingestible device of claim 2, wherein the at least one analyte preservative is a surfactant.

6. The ingestible device of claim 2, wherein the at least one analyte preservative is a stabilizer.

7. The ingestible device of claim 2, wherein the at least one analyte preservative comprises a member selected from the group consisting of a nuclease inhibitor, an RNase inhibitor, and a protease inhibitor.

8. The ingestible device of claim 2, wherein the at least one analyte preservative comprises an acid having a pKa of from three to seven.

9. The ingestible device of claim 2, wherein the at least one analyte preservative comprises a paraben.

10. The ingestible device of claim 5, wherein the surfactant comprises polysorbate.

11. The ingestible device of claim 6, wherein the stabilizer comprises trehalose or dextran.

12. The ingestible device of claim 9, wherein the paraben comprises a member selected from the group consisting of parahydroxybenzoate, an ester of parahydroxybenzoic acid, and propyl paraben.

13. The ingestible device of claim 7, wherein the at least one analyte preservative comprises a protease inhibitor.

14. The ingestible device of claim 13, wherein the protease inhibitor comprises a member selected from the group consisting of serine protease inhibitors, metalloprotease inhibitors, aminopeptidase inhibitors, cysteine peptidase inhibitor, and aspartyl protease inhibitors.

15. The ingestible device of claim 2, wherein the at least one analyte preservative comprises an acid.

16. The ingestible device of claim 2, wherein the at least one analyte preservative comprises at least one member selected from the group consisting of sorbic acid and citric acid.

17. The ingestible device of claim 1, wherein the at least one preservative comprises at least one bacteria preservative.

18. The ingestible device of claim 17, wherein the at least one bacteria preservative reduces bacterial growth and multiplication.

19. The ingestible device of claim 17, wherein the at least one bacteria preservative comprises a bactericidal or bacteriostatic preservative.

20. The ingestible device of claim 17, wherein the at least one bacteria preservative comprises a preservative for at least one bacterium associated with at least one GI disorder.

21. The ingestible device of claim 17, wherein the at least one bacteria preservative comprises a member selected from the group consisting of sorbic acid, citric acid, propyl paraben, nisin, dimethyl dicarbonate, ethylenediaminetetraacetic acid (EDTA), sodium azide, hydroxyurea, fusidic acid, diazolidinyl urea, imidazolidinyl urea, salicylic acid, barium and nickle chloride, metallic copper, thimerosal, 2-phenoxyethanol, and ProClin.

22. The ingestible device of claim 17, wherein the at least one bacteria preservative is sorbic acid, thimerosal, 2-phenoxyethanol, diazolinidyl urea, or imidazolinidyl urea.

23. The ingestible device of claim 2, wherein the at least one absorbent member comprises at least one analyte preservative in addition to the at least one bacteria preservative.

24. The ingestible device of claim 23, wherein the at least one analyte preservative is a nucleic acid preservative.

25. The ingestible device of claim 24, wherein the nucleic acid preservative is a DNAse inhibitor or an RNase inhibitor.

26. The ingestible device of claim 1, wherein the sampling system comprises a plurality of different preservatives.

27. The ingestible device of claim 1, wherein the sampling system further comprises a cell filter between the first and second absorbent members.

28. The ingestible device of claim 1, wherein the sampling system further comprises a cell filter.

29. The ingestible device of claim 1, wherein the fluid comprises a GI fluid.

30. The ingestible device of claim 1, wherein the sampling system is configured to fit within an ingestible device that does not include analytical instrumentation.

31. The ingestible device of claim 1, wherein the at least one preservative is at least partially absorbed in the second absorbent member.

32. A method, comprising:

collecting a sample into the ingestible device of claim 1.

33. The method of claim 32, wherein the at least one preservative is at least partially absorbed in the second absorbent member.