Gastrointestinal tract detection methods, devices and systems

• US 10,610,104 B2
• Filed: 12/07/2017
• Issued: 04/07/2020
• Est. Priority Date: 12/07/2016
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Progenity, Inc. (Athyrium Capital Management LP)
• Inventors: Pak, Brian, McLean, John Mitchell, Smith, Paul Timothy, Jones, Mitchell Lawrence, Wahl, Christopher Loren
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/835,303
• Publication Number:
  US 20180206769A1
• Time in Patent Office: 852 Days
• Field of Search: None
• 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 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• 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: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 49/0019 characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
• CPC Class Codes: A61K 49/0026 : Acridine dyes
• CPC Class Codes: A61K 49/0028 : Oxazine dyes
• CPC Class Codes: A61K 49/0058 : Antibodies
• CPC Class Codes: A61K 49/0069 : the agent being in a particular physical galenical form
• CPC Class Codes: C12M 29/26 : Conditioning fluids entering or exiting the reaction vessel
• CPC Class Codes: C12N 1/20 : Bacteria; Culture media therefor
• CPC Class Codes: C12Q 1/045 : Culture media therefor
• CPC Class Codes: C12Q 1/06 : Quantitative determination
• CPC Class Codes: C12Q 1/10 : Enterobacteria
• CPC Class Codes: G01N 1/10 : in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 1/20 : for flowing or falling materials G01N1/2035 G01N1/12, G01N1/14 take precedence
• CPC Class Codes: G01N 1/38 : Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2001/1031 : Sampling from special places
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 33/4833 : of solid biological material, e.g. tissue samples, cell cultures tissue in vivo A61B5/00; cell suspensions G01N33/48735
• CPC Class Codes: G01N 33/487 : of liquid biological material
• CPC Class Codes: G01N 33/582 : with fluorescent label

Abstract

The present disclosure relates to gastrointestinal (GI) tract detection methods, devices and systems.

Claims

1. A device, comprising:

a diffractive optics sensor, comprising;

a diffraction grating;

an analyte-binding agent linked to a surface of the diffraction grating, wherein the analyte-binding agent is capable of binding to the analyte; and

a detector configured to detect light diffracted by the diffraction grating,

wherein;

the device is configured so that, when the analyte is bound to the analyte-binding agent, a diffraction pattern of light diffracted by the diffraction grating changes;

at least one of the following holds;

the device further comprises a light source configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence of from 30°

to 80°

measured from the surface of the diffraction grating;

the diffraction grating comprises a series of grooves comprising adjacent recessed portions, and raised portions of the grooves have a depth from about 1 nm to about 1000 nm;

the diffraction grating has a period of from 0.5 micron to 50 microns;

the diffraction pattern comprises light in a plurality of diffraction orders, and the detector detects an intensity of light in one or more of the diffraction orders; and

the device is an ingestible device.

2. The device of claim 1, wherein the change in the diffraction pattern comprises a change in an intensity of light diffracted by the diffraction grating.

3. The device of claim 2, wherein a magnitude of the change in the intensity of light diffracted by the diffraction grating is indicative of the concentration of the analyte in the sample.

4. The device of claim 1, further comprising a light source configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence 60°

measured from surface.

5. The device of claim 4, wherein the light source is configured to generate light having a wavelength of 670 nm.

6. The device of claim 1, wherein the diffraction grating has a period of 15 μ

m.

7. The device of claim 1, wherein the diffraction grating comprises a series of grooves comprising adjacent recessed portions and wherein raised portions of the grooves have a depth from about 1 nm to about 1000 nm.

8. The device of claim 1, wherein the diffraction pattern comprises light in a plurality of diffraction orders, and the detector detects an intensity of light in one or more of the diffraction orders.

9. The device of claim 1, wherein the diffraction optics are configured for total internal reflection.

10. The device of claim 1, wherein the analyte comprises a member selected from the group consisting of a biomolecule, a microorganism, a therapeutic agent, a drug, a biomarker, a pesticide, a pollutant, fragments thereof, and metabolites thereof.

11. The device of claim 1, wherein the analyte comprises a member selected from the group consisting of a protein, a nucleic acid, a steroid, a polysaccharide, and a metabolite.

12. The device of claim 1, wherein the analyte comprises a bile acid or a bile acid salt.

13. The device of claim 1, wherein the analyte comprises an antibiotic.

14. The device of claim 1, wherein the analyte is associated with a disease, a disorder, or a pathogen.

15. A method, comprising:

operating an ingestible device within the GI tract of a subject to detect an analyte,

wherein the ingestible device is a device according to claim 1.

16. The device of claim 1, further comprising a light source configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence of from 40°

to 80°

measured from the surface of the diffraction grating.

17. The device of claim 1, further comprising a light source configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence of from 50°

to 70°

measured from the surface of the diffraction grating.

18. The device of claim 1, further comprising a light source configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence of from 55°

to 65°

measured from the surface of the diffraction grating.

19. The device of claim 1, wherein the diffraction grating has a period of from 0.5 micron to 50 microns.

20. The device of claim 1, wherein the diffraction grating comprises a series of grooves comprising adjacent recessed portions, and raised portions of the grooves have a depth from about 200 nm to about 300 nm.

21. The device of claim 1, wherein the detector detects an intensity of diffracted light in a fifth diffraction order.

22. A device, comprising:

a light source; and

a diffractive optics sensor, comprising;

a diffraction grating;

an analyte-binding agent linked to a surface of the diffraction grating, wherein the analyte-binding agent is capable of binding to the analyte; and

a detector configured to detect light diffracted by the diffraction grating,

wherein;

the device is configured so that, when the analyte is bound to the analyte-binding agent, a diffraction pattern of light diffracted by the diffraction grating changes;

at least one of the following holds;

the light source is configured so that light emitted by the light source impinges on the diffraction grating with an angle of incidence of from 30°

to 80°

measured from the surface of the diffraction grating;

the diffraction grating has a period of from 0.5 micron to 50 microns;

the diffraction grating comprises a series of grooves comprising adjacent recessed portions, and raised portions of the grooves have a depth from about 200 nm to about 300 nm;

the detector detects an intensity of diffracted light in a fifth diffraction order; and

the device is an ingestible device.