Device and system for gastric volume reduction to facilitate weight loss

• US 9,827,405 B2
• Filed: 05/26/2011
• Issued: 11/28/2017
• Est. Priority Date: 05/27/2010
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Oral, Elif A., Oral, Hakan
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): Hollm, Jonathan
• Application Number:
  US13/700,368
• Publication Number:
  US 20130131708A1
• Time in Patent Office: 2,378 Days
• Field of Search: 606 1, 606108, 606191-200
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/004 remotely adjustable
• CPC Class Codes: A61F 5/0046 with wireless means
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An ingestible gastric volume reduction device (100) is provided that is controllably adjustable between an expanded state and a contracted state. A control subsystem within the device is able to selectively transition the device between both states. Such control can be by way of a biological or chemical sensor (102) in the device, a wireless (RF) receiver (104), or timer. Thus activation of the device whether to expand and fill a gastric volume or to contract to open up the gastric volume may be achieved from internal control (within device) or external control (to the device). The device may be used for patient treatment, by administering the device (e.g., through ingestion) to a gastric region and then controllably increasing and/or decreasing the volume of the device during treatment.

Claims

1. An ingestible and biologically inert gastric volume reduction device comprising:

a controllably adjustable volume subsystem including a titration system being repeatedly adjustable between an expansion mode of the device and a contraction mode of the device, wherein in the expansion mode, the device increases its volume and in the contraction mode, the device decreases its volume, the titration system comprising a first gas agent that expands the volume in the expansion mode and a second gas agent that reacts with the first gas agent to reduce the volume in the contraction mode; and

a control subsystem including a sensor and a receiver coupled to the volume subsystem and configured to repeatedly selectively set the mode of the device between the expansion mode and the contraction mode;

wherein the titration system, in response to control from the control subsystem, is configured to release the first gas agent in the expansion mode and is configured to release the second gas agent in the contraction mode to reduce the volume to a size that is small enough to allow the device to pass through an intestinal system.

2. The device of claim 1, wherein the control subsystem is configured to have an activation mode in which the device is activatable for operation after being digested into a gastric cavity, and wherein the activation mode is initiated in response to an external signal communicated to the control subsystem from outside the gastric cavity.

3. The device of claim 1, wherein the control subsystem is configured to set the expansion mode in response to receiving a wireless control signal at the receiver from a transmitter external to the device.

4. The device of claim 1, wherein the control subsystem is configured to set the expansion mode in response to the sensor in the control subsystem.

5. The device of claim 1, further comprising an expandable outer shell having at least one inner chamber containing an expandable gas, wherein the expandable outer shell is biodegradable.

6. The device of claim 1, wherein the sensor is either a pH sensor, a light sensor, a chemical sensor, a muscle contraction sensor, or a combination thereof.

7. The device of claim 6, wherein the sensor is ingested in an inactive mode, and is configured to be placed into an active mode in response to the control subsystem.

8. The device of claim 1, wherein the control subsystem operates in a time free manner.

9. The device of claim 1, wherein the control subsystem operates in a time controlled manner.

10. The device of claim 1, further comprising an internal discharge subsystem coupled to the control subsystem and to an outlet on an expandable outer shell, wherein the internal discharge subsystem is capable of releasing a third agent into a gastric cavity in response to the device being in the expansion mode or in the contraction mode.

11. The device of claim 10, wherein the third agent is selected from the grouping consisting of enzymatic agents, medicinal agents, chemical agents, hormones and combinations thereof.

12. The device of claim 1, wherein the control subsystem is configured to repeatedly selectively set the mode of the device by controlling the titration system to selectively release at least one of the first gas agent and the second gas agent.

13. The device of claim 1, wherein the titration system comprises a valve coupled to a plurality of reservoirs each adapted to store one of the first gas agent or the second gas agent, the control system adapted to control the release of the first and the second gas agents from the plurality of reservoirs upon selecting the expansion mode or the contraction mode of the device.

14. A system comprising a plurality of the devices of claim 1, wherein each of the plurality of devices is individually controllable to either expand or contract in volume in response to a controller external to each of the plurality of devices.

15. A method of treating a patient comprising:

administering the device of claim 1 to a gastric region of a patient through ingestion by the patient; and

controlling the volume of the device by releasing the first gas agent that expands the volume of the device in the expansion mode and releasing the second gas agent that reduces the volume of the device in the contraction mode to affect an internal volume of the gastric region.

16. The method of claim 15, further comprising controlling the volume of the device using a sensor, a timer, or an RF receiver.

17. The method of claim 15, comprising performing the administering and the controlling in lieu of performing a bariatric procedure on the patient.

18. The method of claim 15, comprising performing the administering and the controlling in combination with a bariatric procedure performed on the patient.