Feedback systems and methods to enhance obstructive and other obesity treatments, optionally using multiple sensors

• US 9,662,240 B2
• Filed: 01/05/2016
• Issued: 05/30/2017
• Est. Priority Date: 09/23/2004
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Imran, Mir, Province, Rose, Brynelsen, Charles R., Wong, Ken, Potosky, John C.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/988,542
• Publication Number:
  US 20160206457A1
• Time in Patent Office: 511 Days
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 2005/0023 for sensing chemical parameters
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0059 with wireless means
• CPC Class Codes: A61F 5/0069 in the wall of the stomach

Abstract

Feedback systems and methods enhance obstructive and other obesity treatments by presenting feedback regarding patients'"'"' actual eating. An ingestion restricting implant body can be deployed along the gastrointestinal tract. In some embodiments, ingestion alters the implant body, which, in turn, generates signals. The generated signals can be used to inhibit unhealthy ingestion by the patient. In other embodiments, the implant body can be altered by signals so as to selectable change the restriction imposed on the gastrointestinal tract, optionally in response to ingestion events, an eating schedule, or the like. The implant body may comprise a gastric band. Sensor signals may be processed to identify ingestion and/or characterize ingestion material, and the results may be displayed on a screen for a patient or coach to view.

Claims

1. A system for treating a patient, the patient having a body and a gastrointestinal tract, the system comprising:

an ingestion restricting implant body deployable along the gastrointestinal tract;

at least two sensors configured to transmit signals in response to changes of the body of the patient in use, wherein the body of the patient is obese and the at least two sensors include a transgastric probe having a probe body and a transgastric wall transversing portion, the at least two sensors separated along the probe body from the transgastric wall transversing portion so as to be disposed within an interior of the gastrointestinal tract; and

a processor coupled to the at least two sensors, the processor, in response to the signals, generating output comprising at least one member selected from the group consisting of;

display signals based on changes of the body of the patient, and

patient treatment signals.

2. The system of claim 1, wherein the gastrointestinal tract includes a gastric pouch and the at least two sensors are disposed within an interior of the gastric pouch.

3. The system of claim 1, wherein the at least two sensors are selected from the group consisting of a temperature sensor, a visible color sensor, a pressure sensor, a temperature sensor, an optical sensor, an impedance sensor, a pH sensor, an acoustic sensor, an accelerometer, a heart-rate sensor, and/or an infrared light detector.

4. The system of claim 3, wherein the heart-rate sensor comprises an electrode engaging the stomach wall so as to receive far field electric signals from the heart.

5. The system of claim 3, wherein the accelerometer is configured to sense motion of the body of the patient, the motion corresponding to an activity level of the patient.

6. The system of claim 5, wherein a low activity level includes a stationary body and a high activity level includes a moving body.

7. The system of claim 1, further comprising at least one of:

a display coupled to the processor, the display showing ingestion events identified in response to the display signals during a plurality of days and configured for communicating feedback relating to the ingestion events to the patient and/or a health care professional and/or other individuals;

an actuator coupled to the processor so as to alter the ingestion restricting implant body in response to the ingestion event; and

at least two electrodes coupled to the processor so as to stimulate tissue of the gastrointestinal tract in response to the ingestion event so as to encourage healthy ingestion habits for the patient.

8. The system of claim 7, wherein altering the ingestion restricting implant body includes increasing the restriction when the ingestion event is sensed to be unhealthy and decreasing the restriction when the ingestion event is sensed to be healthy.

9. The system of claim 1, further comprising a display showing activity levels identified in response to the display signals during a plurality of days and configured for communicating feedback relating to the activity levels to the patient and/or a health care professional and/or other individuals so as to encourage high activity levels in the patient.

10. A system for treating an obese patient, the patient having a gastrointestinal tract, the system comprising:

an ingestion restricting implant body deployable along the gastrointestinal tract;

at least one responsive element comprising at least one sensor, the at least one sensor configured to transmit signals in response to changes in the gastrointestinal tract in use, wherein the body of the patient is obese and the at least one sensor includes a transgastric probe having a probe body and a transgastric wall transversing portion, the at least one sensor separated along the probe body from the transgastric wall transversing portion so as to be disposed within an interior of the gastrointestinal tract and wherein the responsive element determines the existence of a condition; and

a processor coupled to the at least two sensors, the processor, in response to the signals, generating output comprising at least one member selected from the group consisting of;

display signals based on changes of the body of the patient, and

patient treatment signals.

11. The system of claim 10, wherein the condition is selected from the group consisting of presence of food, ingestion of food, type of food ingested, activity level of the patient, wakefulness of the patient, time of a daily schedule, contractions of the stomach, stress level, and/or nausea.

12. The system of claim 10, wherein the at least one sensor is selected from the group consisting of a temperature sensor, a visible color sensor, a pressure sensor, a temperature sensor, an optical sensor, an impedance sensor, a pH sensor, an acoustic sensor, an accelerometer, a heart-rate sensor, and/or an infrared light detector.

13. The system of claim 10, wherein the responsive element is configured to respond to a condition by interfering with the gastrointestinal tract so as to slow, stop or reverse innate peristaltic contractions.

14. The system of claim 11, wherein the responsive element is configured to stimulate the gastrointestinal tract to retain food for a predetermined period of time in response to the condition.

15. The system of claim 14, wherein the condition includes ingestion of food and/or activity level of the patient.

16. The system of claim 14, wherein the condition includes wakefulness of the patient and/or contractions of the stomach.

17. A method for treating a patient, the patient having a gastrointestinal tract, the method comprising:

deploying at least a portion of an implant along the gastrointestinal tract, the implant having a body, at least three sensors and a processor;

wherein the body of the patient is obese and the at least three sensors include a transgastric probe having a probe body and a transgastric wall transversing portion, the at least three sensors separated along the probe body from the transgastric wall transversing portion so as to be disposed within an interior of the gastrointestinal tract;

identifying, during a day and in response to signals sent from the at least three sensors to the processor, a candidate characterization of an ingested material;

determining whether the ingested material constitutes an allowed ingestion in response to the candidate characterization, and if so, allowing the ingested material to traverse the body of the implant along the gastrointestinal tract;

determining whether the ingested material constitutes an unhealthy ingestion in response to the candidate characterization, and if so, transmitting signals from the processor to the body so as to alter a shape, compliance, and/or size of the body such that the body restricts the unhealthy ingestion.

18. The method of claim 17 further comprising:

communicating feedback to the patient and/or health care professional and/or other individuals, wherein the feedback is based on the determination of whether the ingested material constitutes an unhealthy ingestion or an allowed ingestion; and

wherein communicating feedback provides a behavioral modification component for treating the obese patient.

19. The method of claim 17, wherein the feedback is communicated securely via website, email, telephone, or text message.

20. The method of claim 17, wherein at least one of the at least three sensors is a temperature sensor supported with thermal separation from the implant body.