Methods for manufacturing capsules with ingestible event markers

Patent metadata

Field	Value
Publication number	US-11529071-B2
Application number	US-202017034893-A
Country	US
Kind code	B2
Filing date	Sep 28, 2020
Priority date	Oct 26, 2016
Publication date	Dec 20, 2022
Grant date	Dec 20, 2022

Abstract

Various methods and apparatuses are presented for an ingestible capsule that includes a digital, ingestible sensor component—or ingestible sensor—embedded into the capsule. The ingestible sensor component may be configured to activate upon coming into contact with conductive fluid, such as a body's stomach fluid. Once activated, the ingestible sensor component may be configured to perform various tasks, such as transmitting one or more signals and obtaining biometric data about the body that ingested the capsule.

First claim

What is claimed is:

1. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by wedging the ingestible sensor into the capsule and affixing the ingestible sensor to the capsule using friction forces between edges of the ingestible sensor and an inner wall of the ingestible capsule, using the automated manufacturing process,
wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

2. The method of claim 1 , wherein the ingestible sensor comprises at least a portion of material that is configured to flex or deform upon applying physical pressure, and wherein wedging the ingestible sensor into the capsule comprises flexing or deforming at least a portion of the ingestible sensor as the ingestible sensor is wedged into the capsule.

3. The method of claim 2 , wherein the material that is configured to flex or deform is insoluble and non-conductive and is further configured to magnify a signal emitted from the ingestible sensor by increasing a length of a current path formed between two dissimilar materials positioned on opposite sides of the ingestible sensor.

4. The method of claim 3 , wherein the material that is configured to flex and deform comprises a planar geometry.

5. The method of claim 4 , wherein the material that is configured to flex and deform comprises a rhombus-shaped planar geometry.

6. The method of claim 4 , wherein the material that is configured to flex and deform comprises a planar geometry with at least two lobes.

7. The method of claim 4 , wherein the material that is configured to flex and deform comprises a planar geometry with at least two extended arms.

8. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by:
affixing the ingestible sensor to a first band;
forming an ingestible sensor band by affixing a second band over the ingestible sensor and the first band to sandwich the ingestible sensor in between the first band and the second band; and
affixing the ingestible sensor band to the capsule by wrapping the ingestible sensor band around the capsule;
wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

9. The method of claim 8 , further comprising affixing the ingestible sensor to the first band using a banding ribbon that is configured to be affixed to multiple ingestible sensors.

10. The method of claim 9 , further comprising using a roll-to-roll web-processing manufacturing tool to create the banding ribbon.

11. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by:
embedding the ingestible sensor onto an inner wall of an outer cap; and
affixing the outer cap over at least a portion of the capsule, such that the ingestible sensor is sandwiched between at least a portion of the capsule and the outer cap;

wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

12. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by:
securing an inner wall of the capsule using a support pin;
on an outer wall of the capsule, opposite the inner wall of the capsule supported by the support pin, deforming a portion of the outer wall of the capsule to create a depression, using a deforming pin; and
embedding the ingestible sensor into the depression of the outer wall;

wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

13. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by:
applying a glue material to an inner wall of the capsule; and
securing the ingestible sensor to the inner wall of the capsule via the glue material;

wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

14. The method of claim 13 , wherein the glue material comprises at least one of: polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC), methylcellulose, ethylcellulose, gelatin or hydroxypropyl methylcellulose (HPMC).

15. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by:
deforming a portion of the capsule by applying heat to the portion of the capsule; and
attaching the ingestible sensor to the deformed portion of the capsule;

wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

16. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by attaching an ingestible sensor bead to the capsule using a fluid bed coating;
wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

17. A method of manufacturing an ingestible capsule including an ingestible sensor, the method comprising:
accessing an already-manufactured ingestible capsule; and
modifying the capsule to include an ingestible sensor using an automated manufacturing process by machining a vertical channel into a rounded end of the capsule and placing the ingestible sensor into the vertical channel;
wherein the ingestible sensor includes a partial power source that powers the ingestible sensor when the partial power source comes into contact with a conductive fluid.

18. The method of claim 17 , wherein machining the vertical channel comprises machining a bottom edge into the capsule having a geometry that matches a geometry of an outer edge of the ingestible sensor.

19. The method of claim 18 , wherein the bottom edge of the vertical channel comprises a V-shaped edge.

Assignees

• Otsuka Pharma Co Ltd

Inventors

• Frank Jeremy
• Pargaonkar Nikhil
• Schmidt Raymond
• Azevedo Robert
• Scheinpflug Kurt
• Leist Nikolaus
• Dong Chris
• Patel Hiren
• Bjeletich Peter
• Duck Robert

Classifications

• A61B2562/162

  Capsule shaped sensor housings, e.g. for swallowing or implantation · CPC title

• A61B5/6861 Primary

  Capsules, e.g. for swallowing or implanting · CPC title

• A61J2200/30

  Compliance analysis for taking medication · CPC title

• A61J2200/70

  Device provided with specific sensor or indicating means · CPC title

• A61B5/073 Primary

  Intestinal transmitters · CPC title