Responsive gastric stimulator

• US 8,364,269 B2
• Filed: 10/19/2009
• Issued: 01/29/2013
• Est. Priority Date: 05/01/2001
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Imran, Mir A.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US12/581,730
• Publication Number:
  US 20100094374A1
• Time in Patent Office: 1,198 Days
• Field of Search: 607/40, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61F 2005/0016 comprising measuring means
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

A responsive gastrointestinal stimulation device is provided where one or more sensors sense data corresponding to a subject or the gastrointestinal tract of a subject and responds to sensing the data by stimulating, adjusting stimulation, or stopping stimulation of the gastrointestinal tract. A stimulation device is also provided to stimulate the gastrointestinal tract to produce a sensation of satiety or to control hunger or food consumption.

Claims

1. A method comprising:

receiving data sensed from an implantable sensor system implanted inside a patient, the sensor system including a transgastric probe having an intragastric sensor disposed within a cavity of a stomach of the patient so as to generate intragastric sensed data, and an accelerometer so as to generate activity sensed data;

determining a characteristic of material ingested by the patient in response to the intragastric sensed data;

determining a gross activity level of the patient in response to the activity sensed data, wherein the determining of the gross activity level comprises determining a period when the patient is sleeping, determining a period when the patient has a wakeful gross activity level, and determining a period when the patient has a higher exertion gross activity level, the higher exertion activity level being more active than the wakeful activity level;

transmitting signals from implanted electronic circuitry of the implantable device to external circuitry outside the patient, and outputting the ingested material characteristic and gross activity level from the external circuitry in response to the signals, wherein outputting the ingested material characteristic and gross activity level comprises communicating to a physician of the patient; and

adjusting an obesity therapy of the patient in response to the ingested material characteristic and in response to the gross activity level of the patient.

2. The method of claim 1, wherein outputting the ingested material characteristic and gross activity level comprises communicating to the patient via at least one member selected from the group consisting of:

a display and/or

an auditory alert.

3. The method of claim 1, further comprising communicating the characteristic of ingested material and the gross activity level from the external circuitry to a computer via a port, the port providing bi-directional communication between the computer and the external circuitry.

4. The method of claim 1, wherein the implantable device comprises a stimulator, and wherein the adjusting of the obesity therapy comprises altering a protocol for electrical stimulation of the tissue of the patient with the implantable device.

5. The method of claim 1, wherein adjusting of the obesity therapy comprises altering a protocol for electrical stimulation of a tissue of the patient with the implantable device in response to the identified sleeping period and in response to the identified higher exertion period, wherein the electrical stimulation of the tissue is inhibited during the identified sleeping period and during the identified higher exertion period.

6. The method of claim 1, wherein the characteristic of the material comprises a composition of the material, and wherein the determination of the characteristic comprises generating an optical signal indicative of the composition.

7. The method of claim 6, wherein adjusting the obesity therapy comprises adjusting the obesity therapy in response to the composition of the ingested material departing from an approved ingestion regimen.

8. The method of claim 1, further comprising identifying gastric contractions of the patient in response to the data.

9. The method of claim 1, further comprising observing patterns of the patient over time in response to the data.

10. The method of claim 1, further comprising adjusting the obesity therapy so as to promote weight loss by the patient.

11. A device comprising:

an implantable sensor system coupleable to tissues of a patient so as to sense data from within the patient, the sensor system including a temperature sensor and an accelerometer; and

circuitry coupled to the sensor system, the circuitry configured to determine a characteristic of material ingested by the patient in response to a rate of change of the sensed data, and to determine a gross activity level of the patient in response to the sensed data so as to allow an obesity therapy of the patient to be adjusted in response to the ingested material characteristic and in response to the gross activity level of the patient, wherein the circuitry comprises implantable circuitry and external circuitry configured to be disposed outside the patient during use with telemetry for transmitting signals therebetween, and wherein the circuitry is configured;

so as to identify a sleeping period in response to the sensed data,

so as to identify a wakeful period in response to a wakeful gross activity level of the sensed data, and

so as to identify a period when the patient has a higher exertion gross activity level in response to a higher gross activity level of the sensed data, the higher exertion activity level being more active than the wakeful activity level; and

an output coupled to the external circuitry for outputting the ingested material characteristic and gross activity level in response to the signals.

12. The device of claim 11, wherein the output comprises at least one member selected from the group consisting of:

a display and/or

an auditory alert.

13. The device of claim 11, wherein the external circuitry comprises a port coupleable to a computer so as to communicate the characteristic of ingested material and the gross activity level from the external circuitry, the port providing bi-directional communication between the computer and the external circuitry.

14. The device of claim 13, wherein the implantable device comprises a stimulator, and wherein the circuitry adjusts the obesity therapy by altering a protocol for electrical stimulation of a tissue of the patient with the implantable device.

15. The device of claim 11, wherein the obesity therapy of the patient is adjusted in response to the identified sleeping period.

16. The device of claim 15, wherein the implantable device comprises a stimulator, and wherein the circuitry adjusts the obesity therapy by altering a protocol for electrical stimulation of a tissue of the patient with the implantable device in response to the identified sleeping period.

17. The device of claim 11, wherein the characteristic of the material comprises a composition of the material, and wherein the sensor comprises an optical signal sensor implantable in communication with an interior of the gastric system so as to sense an optical signal indicative of the composition.

18. The device of claim 17, wherein the circuitry compares the composition of the ingested material to an approved ingestion regimen and adjusts the obesity therapy when the composition diverts from the approved regimen.

19. The device of claim 11, wherein the circuitry is configured for identifying gastric contractions of the patient in response to the data.

20. The device of claim 11, wherein the circuitry comprises a memory configured to facilitate observing patterns of the patient over time in response to the data.

21. A system comprising:

an implantable sensor system configured to be coupled to a tissue within a patient so as to sense data therefrom, the sensor system comprising an accelerometer and an intragastric temperature sensor, the sensed data comprising accelerometer signals from the accelerometer and intragastric temperature signals from within an interior cavity of a stomach of the patient; and

a processor coupled to the sensor system, the processor determining a gross activity level of the patient in response to the sensed data so as to allow an obesity therapy of the patient to be adjusted in response thereto, wherein the processor is configured to identify;

a wakeful period in response to a wakeful gross activity level of the accelerometer signals; and

a higher exertion activity period in response to a gross activity level of the accelerometer signals higher than the wakeful gross activity level;

the processor including implantable circuitry, external circuitry for use outside the patient body, and wireless telemetry coupling the implanted and external circuitry; and

an output coupled to the external circuitry so as to indicate the gross activity level.