Ingestable sampling devices

Abstract

The present invention relates to an ingestible cell sampling device for sampling target cells, and a method of using the same to detect abnormalities in the target. [Solution] The ingestible cell sampling device comprises i) an abrasive sponge housed in a soluble capsule, wherein the abrasive sponge has an outer surface exposed to the external environment, ii) a molded cap, and iii) a string having a first end attached to the molded cap.

Claims

1. A cell sampling device that can be ingested, i) An abrasive sponge contained within a soluble capsule, wherein the soluble capsule has an outer surface exposed to the external environment, and the abrasive sponge, ii) Molded cap and, iii) The ingestible cell sampling device comprising a string having a first end attached to the molded cap.

2. The ingestible cell sampling device according to claim 1, further comprising a handle attached to the string, preferably a non-swallowable handle.

3. The ingestible cell sampling device according to claim 1 or 2, wherein the abrasive sponge comprises a mesh foam.

4. The ingestible cell sampling device according to any one of the prior claims, wherein the polishing sponge is compressible.

5. The ingestible cell sampling device according to claim 4, wherein the abrasive sponge is held in a compressed state by the soluble capsule.

6. An ingestible cell sampling device according to any one of the prior claims, wherein the abrasive sponge has at least one cavity in an uncompressed state.

7. The ingestible cell sampling device according to claim 6, wherein the string passes through at least one cavity, preferably at least one recess.

8. The ingestible cell sampling device according to any one of the prior claims, wherein the soluble capsule has one or more openings, and a portion of the abrasive sponge is exposed to the external environment through the one or more openings.

9. The soluble capsule comprises a first end and a second end, a) The first end is closed, and the second end is closed, or b) The ingestible cell sampling device according to any one of the prior claims, wherein the first end is closed and the second end is open.

10. The ingestible cell sampling device according to claim 9, wherein the molded cap comprises an inner surface and an outer surface, the inner surface of the cap contacts the outer surface of the capsule at the first closing end, and the outer surface of the cap contacts the external environment.

11. The ingestible cell sampling device according to claim 9, wherein the molded cap comprises an inner surface and an outer surface, and the inner surface of the cap is in contact with the polishing sponge.

12. The ingestible cell sampling device according to claim 11, wherein the outer surface of the cap is in contact with the inner surface of the capsule at the first closed end.

13. The ingestible cell sampling device according to claim 11 or 12, wherein the inner surface of the cap is attached to the polishing sponge by adhesive.

14. The ingestible cell sampling device according to claim 9, wherein the molded cap comprises an inner surface of the cap in contact with the polishing sponge and an outer surface of the cap in contact with the external environment.

15. The ingestible cell sampling device according to claim 14, wherein the inner surface of the cap is attached to the polishing sponge.

16. The ingestible cell sampling device according to claim 15, wherein the inner surface of the cap is attached to the polishing sponge by adhesive.

17. The ingestible cell sampling device according to any one of the prior claims, wherein the string is attached to the molded cap by knots and / or adhesive.

18. The ingestible cell sample device according to any one of the prior claims, wherein the string has one or more calibration markings.

19. The ingestible cell sampling device according to any one of the prior claims, wherein the string includes a suture.

20. The ingestible cell sampling device according to any one of the prior claims, wherein the string passes through a portion of the polishing sponge.

21. The ingestible cell sampling device according to any one of the prior claims, wherein the molded cap includes a button.

22. A system or kit for obtaining a cell sample from a subject, comprising an ingestible cell sampling device as described in any one of the prior claims, i) A container for receiving a polishing sponge containing the collected cells, ii) Cell preservation reagents, preferably buffering reagents, iii) Slide glass, iv) Assay plate, v) Local anesthetic agent, preferably a local anesthetic spray, vi) Components of a drinkable solution, preferably a pre-mixed drinkable solution, and vii) The system or the kit further comprising one or more lubricants, preferably lubricating gels or liquids.

23. A method for obtaining cell samples from a subject, i) Orally administering to the subject an abrasive sponge contained within a soluble capsule of the ingestible cell sampling device according to any one of claims 1 to 21, ii) The method comprising withdrawing the polishing sponge from the object, wherein the polishing sponge collects a cell sample from the object during the withdrawal.

24. The method according to claim 23, wherein the extraction occurs within 10 minutes of oral administration.

25. The method according to claim 23 or 24, wherein during the oral administration, the subject swallows the soluble capsule of the ingestible cell sampling device.

26. A method for characterizing a cell sample collected according to any one of claims 23 to 25, comprising assaying the cell sample for at least one biomarker.

27. The method according to claim 26, wherein the at least one biomarker comprises one or more proteins and nucleic acids.

28. The method according to claim 26 or claim 27, wherein the at least one biomarker comprises DNA containing at least a portion of a gene selected from the group consisting of NDRG4, ZNF682, VAV3, BMP3, ZNF568, FER1L4, ANKRD13B, CD1D, CDKN2A, CHST2, CNNM1, DIO3, DOCK2, DTX1, ELMO1, FERMT3, FLI1, GRIN2D, HUNK, JAM3, LRRC4, OPLAH, PDGFD, PKIA, PPP2R5C, QKI, SEP9, SFMBT2, SLC12A8, TBX15, TSPYL5, ZNF304, and ZNF671.

29. The method according to claim 28, wherein assaying the at least one biomarker includes determining the DNA to determine the methylation status of the gene.

30. Assaying for at least one of the above biomarkers is possible for NDRG4, ZNF682, VAV3, BMP3, ZNF568, FER1L4, ANKRD13B, CD1D, CDKN2A, CHST2, CNNM1, DIO3, DOCK2, DTX1, ELMO1, FERMT3, FLI1, GRIN2D, HUNK, JAM3, LRRC4, OPLAH, PDGFD, PKIA, PPP2R5C, QKI, and SEP9. The method according to any one of claims 26 to 29, comprising assaying 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, or 33 of the biomarkers from the group consisting of SFMBT2, SLC12A8, TBX15, TSPYL5, ZNF304, and ZNF671.

31. Assaying for at least one of the above biomarkers is possible for NDRG4, ZNF682, VAV3, BMP3, ZNF568, FER1L4, ANKRD13B, CD1D, CDKN2A, CHST2, CNNM1, DIO3, DOCK2, DTX1, ELMO1, FERMT3, FLI1, GRIN2D, HUNK, JAM3, LRRC4, OPLAH, PDGFD, PKIA, PPP2R5C, QKI, S The method according to claim 30, comprising assaying the methylation status of one, two, three, four, five, six, seven, eight, nine, ten, one, two, three

32. The method according to any one of claims 28 to 30, wherein assaying the at least one biomarker comprises assaying the methylation status of at least one gene selected from the group consisting of ANKRD13B, CHST2, CNNM1, DOCK2, DTX1, FER1L4, FERMT3, FLI1, GRIN2D, JAM3, LRRC4, OPLAH, PDGFD, PKIA, PPP2R5C, QKI, SEP9, SFMBT2, SLC12A8, TBX15, TSPYL5, VAV3, ZNF304, ZNF568, and ZNF671.

33. The method according to any one of claims 28 to 30, wherein assaying the at least one biomarker comprises assaying the methylation status of at least one gene selected from the group consisting of BMP3, NDRG4, VAV3, SFMBT2, DIO3, HUNK, ELMO1, CD1D, CDKN2A, and OPLAH.

34. The method according to any one of claims 28 to 30, wherein assaying the at least one biomarker comprises assaying the methylation status of at least one gene selected from the group consisting of NDRG4, ZNF682, VAV3, BMP3, ZNF568, and FER1L4.

35. The method according to claim 34, comprising assaying the methylation status of the group of genes consisting of NDRG4, ZNF682, VAV3, BMP3, ZNF568, and FER1L4.

Images