Capsule for gastrointestinal sampling

Patent metadata

Field	Value
Publication number	US-12514569-B2
Application number	US-202017785166-A
Country	US
Kind code	B2
Filing date	Dec 16, 2020
Priority date	Dec 16, 2019
Publication date	Jan 6, 2026
Grant date	Jan 6, 2026

Abstract

Passive devices for non-invasive gastrointestinal (GI) sampling are disclosed. In some embodiments, a device includes a capsule housing containing an absorbent sampling hydrogel. The capsule may be ingested by a patient and subsequently travel through the GI tract. Once the capsule reaches a desired location in the GI tract, GI fluid may flow into the capsule through a sampling aperture of the capsule. The fluid may be absorbed by and stored within the sampling hydrogel for subsequent analysis, and the absorption of the fluid may cause the sampling hydrogel to expand within the capsule. The capsule may further include a sealing member positioned between the sampling hydrogel and the sampling aperture, and the expansion of the sampling hydrogel may press the sealing member against the sampling aperture to seal the capsule.

First claim

What is claimed is:

1 . A device for passive sampling of a gastrointestinal tract, the device comprising:
a capsule housing having a first housing portion and a second housing portion that cooperate to bound a cavity; a sampling aperture formed in the first housing portion of the capsule housing and providing fluid communication between the cavity and an exterior of the capsule housing; a solution casted enteric coating covering the sampling aperture of the first housing portion, wherein the sampling aperture is formed in a recess of the first housing portion, the enteric coating is received within the recess, and degradation of the enteric coating exposes the sampling aperture to permit flow into the cavity.

2 . The device of claim 1 , wherein the enteric coating is configured to degrade at a predetermined location in the gastrointestinal tract.

3 . The device of claim 1 , wherein the enteric coating has a thickness of 50 μm.

4 . The device of claim 1 , wherein the enteric coating comprises materials selected from carboxylic acid groups, poly methacrylic acid-co-ethyl acrylate, poly methacrylic acid-co-methyl methacrylate, hydroxypropyl methylcellulose phthalate polymers, hypromellose phthalate, cellulose acetate phthalate, and polyvinyl acetate phthalate.

5 . The device of claim 1 , wherein the enteric coating has a flat outer surface.

6 . The device of claim 1 , wherein the enteric coating extends across only a partial portion of the capsule housing.

7 . The device of claim 1 , wherein the first housing portion and the second housing portion are configured to attach to each other through at least one of a screw interface, a snap fit, or an interference fit.

8 . The device of claim 1 , wherein the enteric coating is circular.

9 . The device of claim 1 , further comprising a sampling hydrogel positioned inside the cavity and a sealing member positioned between the sampling hydrogel and the sampling aperture, wherein upon exposure to a sample fluid, the sampling hydrogel is configured to absorb the sample fluid, expand within the cavity to move the sealing member into sealing engagement with the sampling aperture, and store the sample fluid for subsequent analysis.

10 . The device of claim 1 , wherein the solution casted enteric coating is formed by drop casting.

11 . A method of manufacturing a device for passive sampling of a gastrointestinal tract, the method comprising:
providing a first housing portion of a capsule housing, the first housing portion defining a sampling aperture, and a second housing portion, wherein the first and second housing portions are configured to be assembled to form the capsule housing having a cavity, the sampling aperture providing fluid communication between the cavity and an exterior of the capsule housing; forming an enteric coating over the sampling aperture using a solution casting technique to cover the sampling aperture, wherein the forming the enteric coating comprises
dissolving a polymer in a liquid solution to form a polymer solution;
depositing the polymer solution onto the first housing portion while the first housing portion is positioned on a holder that blocks the sampling aperture, thus preventing the polymer solution from passing through the aperture; and
drying the polymer solution to form the enteric coating over the sampling aperture.

12 . The method of claim 11 , wherein the solution casting technique comprises use of a doctor blade.

13 . The method of claim 11 , wherein the enteric coating is formed over only a portion of the capsule housing to cover the sampling aperture.

14 . The method of claim 11 , wherein the enteric coating is formed as a plane.

15 . The method of claim 11 , further comprising providing a sampling hydrogel inside the cavity, wherein upon exposure to a sample fluid, the sampling hydrogel is configured to absorb the sample fluid, expand within the cavity, and store the sample fluid for subsequent analysis.

16 . The device of claim 12 , wherein using the doctor blade comprises running the blade over a surface of the deposited solution before the solution dries.

17 . The method of claim 11 , wherein the solution casting technique comprises drop casting.

18 . The method of claim 11 , wherein the enteric coating is circular in shape.

19 . The method of claim 11 , wherein the holder is a silicone holder.

20 . The method of claim 11 , wherein the first housing portion and the second housing portion are configured to attach to each other through at least one of a screw interface, a snap fit, and an interference fit.

21 . The method of claim 11 , further comprising positioning a sampling hydrogel within at least one of the first housing portion and the second housing portion, and attaching the first housing portion to the second housing portion such that the sampling hydrogel is positioned inside the cavity.

22 . The method of claim 21 , further comprising placing a sealing membrane between the sampling hydrogel and the sampling aperture before attaching the first housing portion to the second housing portion.

23 . The method of claim 20 , wherein the enteric coating is biodegradable, such that degradation of the biodegradable coating exposes the sampling aperture to permit fluid flow into the cavity.

24 . The method of claim 23 , wherein the biodegradable coating is configured to degrade at a predetermined location in the gastrointestinal tract.

25 . The method of claim 21 , further comprising subjecting an exterior surface of the first housing portion and an exterior surface of the second housing portion to a plasma treatment to form a hydrophilic coating.

Assignees

• Lilly Co Eli

Inventors

• Nejati Sina
• Rahimi Rahim
• Verma Mohit Singh
• Waimin Almendares Jose Fernando
• Wang Jiangshan

Classifications

• A61B2010/0061

  Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions · CPC title

• A61B10/02

  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 title

• A61B10/0045 Primary

  Devices for taking samples of body liquids · CPC title