Gastroretentive articles for alcohol sensing

Patent metadata

Field	Value
Publication number	US-12138034-B2
Application number	US-202318541818-A
Country	US
Kind code	B2
Filing date	Dec 15, 2023
Priority date	May 12, 2020
Publication date	Nov 12, 2024
Grant date	Nov 12, 2024

Abstract

Drug delivery articles, resident articles, and retrieval systems e.g., for gram-level dosing, are generally provided. In some embodiments, the residence articles are configured for transesophageal administration, transesophageal retrieval, and/or gastric retention to/in a subject. In certain embodiments, the residence article includes dimensions configured for transesophageal administration with a gastric resident system. In some cases, the residence article may be configured to control drug release e.g., with zero-order drug kinetics with no potential for burst release for weeks to months. In some embodiments, the residence articles described herein comprise biocompatible materials and/or are safe for gastric retention. In certain embodiments, the residence article includes dimensions configured for transesophageal retrieval. In some cases, the residence articles described herein may comprise relatively large doses of drug (e.g., greater than or equal to 1 gram).

First claim

What is claimed is:

1. A gastric residence article, comprising:
a sensor associated with the gastric residence article; and
one or more drug delivery modules in electrical and/or wireless communication with the sensor;
wherein the gastric residence article is configured to be administered to a subject and to be retained at a location internal to the subject for at least 24 hours,
wherein the gastric residence article has a first configuration sized and adapted for transesophageal administration to a subject,
wherein the gastric residence article has a second configuration sized and adapted such that the gastric residence article is retained in the stomach and prevented from passing through the pylorus, and
wherein the sensor, upon detection of one or more biophysical conditions in the location internal the subject, is configured to trigger release of at least one therapeutic agent from the one or more drug delivery modules to the location internal the subject.

2. The gastric residence article as in claim 1 , wherein the gastric residence article is configured to dissociate such that the sensor dissociates from the gastric residence article and may exit the subject.

3. The gastric residence article as in claim 1 , wherein the gastric residence article is configured to be retrieved via the esophagus of the subject from the location internal the subject.

4. The gastric residence article as in claim 1 , further comprising a gas permeable membrane located with respect to the sensor such that the sensor is protected from gastrointestinal fluid when the gastric residence article is administered to the subject.

5. The gastric residence article as in claim 4 , wherein the gas permeable membrane comprises polytetrafluoroethylene, silicone, or combinations thereof.

6. The gastric residence article as in claim 1 , comprising an electronic component comprising a wireless transmitter, wherein the wireless transmitter is configured to transmit a signal from the location internal to the subject to a receiver positioned extracorporeal of the subject.

7. The gastric residence article as in claim 1 , wherein the gastric residence article further comprises a degradable linker.

8. The gastric residence article as in claim 1 , wherein the location internal to the subject is the stomach.

9. The gastric residence article as in claim 1 , wherein the gastric residence article comprises a linker that degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity of the gastric residence article and facilitates passage of the sensor and/or gastric residence article device out of a gastric cavity.

10. The gastric residence article as in claim 1 , further comprising polymeric arms configured to maintain structural integrity during the second configuration.

11. The gastric residence article as in claim 1 , wherein the gastric residence article comprises a polymeric material having a reconfigurable shape and a hollow core.

12. The gastric residence article as in claim 1 , wherein the gastric residence article has a maximum dimension of greater than or equal to 28 cm.

13. The gastric residence article as in claim 1 , wherein the at least one therapeutic agent is present in the gastric residence article in an amount greater than or equal to 1 gram.

14. The gastric residence article as in claim 11 , further comprising an elastic wire disposed within the hollow core.

15. The gastric residence article as in claim 1 , further comprising a magnetic component.

16. The gastric residence article as in claim 14 , wherein the elastic wire comprises a superelastic alloy and/or shape memory material.

17. A method, comprising administering, to the subject, a gastric residence article as in claim 1 .

18. The gastric residence article as in claim 1 , wherein the first configuration has a largest cross-sectional dimension that is between about 10% and 80% less than the largest cross-sectional dimension of the second configuration.

19. The gastric residence article in claim 1 , wherein the gastric residence article has a third configuration in which a degradable portion of the gastric residence article dissolves, degrades, and/or mechanically weakens, such that the gastric residence article dissociates from the sensor, thereby allowing the sensor to exit the stomach via the pylorus.

20. The gastric residence article as in claim 1 , wherein the sensor is selected from the group consisting of a biomolecular and/or biochemical sensor, a gas sensor, a temperature sensor, a pressure sensor, a motion sensor, an accelerometer, and a pH sensor.

21. The gastric residence article, comprising:
a sensor physically coupled with the gastric residence article; and
one or more drug delivery modules;
wherein the gastric residence article is configured to be administered to a subject and to be retained at a location internal to the subject for at least 24 hours,
wherein the gastric residence article has a first configuration sized and adapted for transesophageal administration to a subject,
wherein the gastric residence article has a second configuration sized and adapted such that the gastric residence article is retained in the stomach and prevented from passing through the pylorus, and
wherein the sensor, upon detection of one or more biophysical conditions in the location internal the subject, is configured to trigger release of at least one therapeutic agent from the one or more drug delivery modules to the location internal the subject.

Assignees

• Massachusetts Inst Technology
• Brigham & Womens Hospital Inc
• Massachusetts Gen Hospital

Inventors

• Langer Robert S
• Traverso Carlo Giovanni
• Verma Malvika
• Eweje Feyisope
• Steiger Christoph Winfried Johannes
• Li Junwei
• Phan Nhi
• Huang Hen-Wei
• Chu Jacqueline
• Salama John Ashraf Fou

Classifications

• A61B2562/02

  Details of sensors specially adapted for in-vivo measurements · CPC title

• A61B2562/164

  the sensor is mounted in or on a conformable substrate or carrier · CPC title

• A61B2562/162

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

• A61B5/4845 Primary

  Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence) · CPC title

• Y02A90/10

  Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation · CPC title