Sampling device for drug development and diagnosis of gastric-intestinal diseases

Patent metadata

Field	Value
Publication number	US-2020367828-A1
Application number	US-201916958165-A
Country	US
Kind code	A1
Filing date	Jan 2, 2019
Priority date	Jan 2, 2018
Publication date	Nov 26, 2020
Grant date	—

Abstract

An ingestible electronic capsule for the collection of samples along a gastric intestinal tract and methods relating thereto are provided. The ingestible electronic capsule includes a housing and a cap that form an interior chamber. The cap includes a sampling port and one or more sample collection chambers are disposed within the interior chamber. A motor is also disposed within the interior chamber and is configured to rotate one of the cap and the one or more sample collection chambers so to align one or the one or more sample collection chambers and the sampling port of the cap so to allow for sample collection. A microcontroller is also disposed within the interior chamber and is in communication with at least the motor. The microcontroller is configured to control the selective alignment of the sampling port and one of the one or more sample collection chambers and induce gastric intestinal fluid sampling.

First claim

1 . An ingestible electronic device for collecting samples along a gastric-intestinal tract, the ingestible electronic device comprising:
a housing; a cap connected to the housing and comprising a surface defining a sampling port; one or more sample collection chambers within the housing and configured to collect the gastric-intestinal samples, where the one or more sample collection chambers includes a wall which is mechanically deformable; a rotatable shaft disposed within the housing and is configured to rotate one of the cap or the one or more sample collection chambers; a motor connected to the rotatable shaft within the housing and configured to axially rotate the rotatable shaft; and a microcontroller configured to control the motor and rotatable shaft so as to selectively align the sampling port of the cap with at least one of the sample collection chambers, thereby exposing the at least one sample collection chamber to the gastric-intestinal tract for collection of one or more gastric-intestinal fluid samples.

2 . The ingestible electronic device of claim 1 , wherein each sample collection chamber comprise one or more deformable cartridges.

3 . The ingestible electronic device of claim 2 , wherein at least one of the deformable cartridges comprises foam material having a porosity ranging from greater than or equal to about 30% to less than or equal to about 90%,
wherein the foam material has an average pore diameter ranging from greater than or equal to about 50 nm to less than or equal to about 500 μm and by controlling the average pore diameters particles from drug products and select intestinal content are prevented from entering the deformable cartridges.

4 . The ingestible electronic device of claim 3 , wherein the foam material is chemically pretreated to enhance at least one of the chemical stability of the gastric-intestinal fluid sample and affinity of the sample collection chamber during the sampling period and during the sample extraction process.

5 . The ingestible electronic device of claim 1 , wherein each sample collection chamber of the one or more sample collection chambers comprises a first end, a second end, and sidewalls connecting the first end and the second end.

6 . The ingestible electronic device of claim 5 , wherein at least one sample collection chamber of the one or more sample collection chambers retains a time-correlated profile of the one or more gastric-intestinal fluid samples between the first end and the second end.

7 . The ingestible electronic device of claim 5 , wherein the first end is configured for exposure to the gastric-intestinal tract for sample collection and the second end and sidewalls are covered by a sealing coating.

8 . The ingestible electronic device of claim 7 , wherein the sealing coating comprises an impervious polymer.

9 . The ingestible electronic device of claim 1 , wherein interior surfaces of one or more of the cap and the housing are coated with a silicon-based grease.

10 . The ingestible electronic device of claim 1 , wherein the rotatable shaft comprises a protrusion that is configured to deform one or more of the one or more sample collection chambers so as to induce a negative vacuum effect with regard to the one or more sample collection chambers such to facilitate gastric-intestinal fluid sample collection.

11 . The ingestible electronic device of claim 1 , further comprising one or more sensors operatively connected to the microcontroller,
wherein the one or more sensors are configured to obtain at least one of a temperature of the gastric-intestinal tract in the vicinity of the ingestible electronic device, a pH of the gastric-intestinal tract in the vicinity of the ingestible electronic device, a pressure of the gastric-intestinal tract in the vicinity of the ingestible electronic device, a specific force of the ingestible electronic device, and an angular rate of the ingestible electronic device.

12 . The ingestible electronic device of claim 1 , wherein the microcontroller comprises a transceiver configured to obtain a signal instructing the ingestible electronic device to perform gastric-intestinal fluid sample collection.

13 . The ingestible electronic device of claim 1 , wherein the ingestible electronic device has a diameter of greater than or equal to about 10 mm to less than or equal to about 14 mm and a length of greater than or equal to about 25 mm to less than or equal to about 30 mm.

14 . The ingestible electronic device of claim 1 , wherein the ingestible electronic device is less than about 10 grams in weight.

15 . The ingestible electronic device of claim 1 , wherein the ingestible electronic device has a length of greater than or equal to about 25 mm to less than or equal to about 30 mm and a variable diameter along the length.

16 . The ingestible electronic device of claim 1 , wherein the ingestible electronic device comprises first and second distal ends and at least one of the first and second distal ends is curved to improve transit through the gastric-intestinal tract.

17 . The ingestible electronic device of claim 1 , further comprising one or more batteries, wherein the one or more batteries provide an operational time of not less than about 40 hours of deployment within the gastric-intestinal tract.

18 .- 33 . (canceled)

34 . An ingestible electronic device for collecting samples along a gastric-intestinal tract, the ingestible electronic device comprising:
a housing; a cap connected to the housing and comprising a surface defining a sampling port; a rotatable shaft disposed within the housing; a motor connected to the rotatable shaft within the housing and configured to axially rotate the rotatable shaft; one or more mechanically deformable sample collection chambers within the housing and configured to collect the gastric-intestinal samples, wherein each sample collection chamber of the one or more sample collection chambers includes a first end, a second end, and sidewalls connecting the first end and the second end, such that the first end is configured for exposure to the gastric-intestinal tract for sample collection, portions of the side walls are mechanically deformable, and the second end and sidewalls are covered by an impervious polymer; a microcontroller configured to control the motor and rotatable shaft so as to selectively align the sampling port of the cap with at least one of the sample collection chambers, thereby exposing the at least one sample collection chamber to the gastric-intestinal tract for collection of one or more gastric-intestinal fluid samples; and two or more batteries residing in the housing and configured to provide two disparate power sources, one each for the microcontroller and the motor.

Assignees

• Univ Michigan Regents

Inventors

• Sun Duxin
• Gianchandani Yogesh B
• Li Tao
• Liao Jinhui
• Cheng Qisen
• Lewis Johnathan
• MEREDITH Ryan
• Felton Jeremy

Classifications

• A61B10/0045 Primary

  Devices for taking samples of body liquids · CPC title

• A61B5/4255

  Intestines, colon or appendix · CPC title

• A61B5/073

  Intestinal transmitters · CPC title

• A61B5/6861 Primary

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

• A61B2560/0214

  of power generation or supply · CPC title