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

• US 9,259,342 B2
• Filed: 12/08/2014
• Issued: 02/16/2016
• Est. Priority Date: 09/23/2004
• Status: Expired due to Fees

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Wong, Ken, Potosky, John C., Province, Rose, Brynelsen, Charles R., Imran, Mir
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/563,686
• Publication Number:
  US 20150094526A1
• Time in Patent Office: 435 Days
• US Class Current: 1/1
• 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 therapeutic implant system for treating an overweight patient, the patient having a gastrointestinal tract and an unhealthy ingestion pattern, the therapeutic implant system comprising:

an ingestion restricting implant body deployable along the gastrointestinal tract so as to separate the gastrointestinal tract into a restricted portion of the gastrointestinal tract and a gastric pouch portion of the gastrointestinal tract upstream of the restricted portion, the implant body comprising a gastric band defining a channel therethrough, the gastrointestinal tract extendable through the channel of the implant body, wherein the gastric band comprises a fluid-filled pressure bladder disposed between the channel and a support structure such that changes in a fluid pressure within the fluid pressure bladder correspond with changes in an engagement force between the gastrointestinal tract and the gastric band;

a sensor coupleable to the gastric pouch portion of the gastrointestinal pouch so that signals are generated in response to transient changes in the gastric pouch and the signals indicate an ingestion event;

a processor coupled to the signal generator and the implant body;

a display coupled to the processor, the display showing eating events identified in response to the signals during a plurality of days and configured for communicating feedback to the patient, a peer group member, a health care professional, or a lifestyle coach;

an actuator coupled to the processor so as to alter the fluid pressure within the bladder in response to the ingestion event; and

at least two electrodes coupled to the processor so as to stimulate tissue of the gastrointestinal tract such that, in response to the signals, the unhealthy ingestion pattern by the patient is inhibited in use sufficiently to modify the unhealthy ingestion pattern toward a healthier ingestion pattern.

2. The system of claim 1, wherein signals are transmitted to the bladder from the processor, and wherein the altering of the engagement force is induced by an actuator in response to the sensor signals so that the pressure within the bladder is decreased each day to allow healthy ingestion and increased each day to inhibit unhealthy ingestion.

3. 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 two sensors so as to transmit signals in response to ingestion into the patient in use, wherein the at least two sensors include a transgastric probe having a probe body and a transgastric wall traversing portion, the at least two sensors separated along the probe body from the transgastric wall traversing 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;

ingestion display signals based on ingestion into the patient, and

patient treatment signals.

4. The system of claim 3, wherein the gastrointestinal tract includes a gastric pouch and the at least two sensors are disposed within an interior of the gastric pouch.

5. The system of claim 3, 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 eccelerometer, a heart-rate sensor, and/or an infrared light detector.

6. The system of claim 3, 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 to the patient 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.

7. The system of claim 6, 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 health.

8. A therapeutic implant system for treating a patient, the patient having a gastrointestinal tract and an unhealthy ingestion pattern, the therapeutic implant system comprising:

an ingestion restricting implant body implantable along the gastrointestinal tract so as to separate the gastrointestinal tract into a restricted portion of the gastrointestinal tract and a gastric pouch portion of the gastrointestinal tract upstream of the restricted portion;

at least two sensors configured to engage the gastric pouch portion, wherein the sensor is included in a transgastric probe having a probe body and a transgastric wall traversing portion, the sensor separated along the probe body from the wall traversing portion so as to be disposed within an interior of the gastric pouch; and

a processor coupleable to the sensor so as to transmit signals therebetween, wherein the signals are transmitted in correlation with transient changes in the gastric pouch potion of the gastrointestinal tract in use.

9. The system of claim 8, wherein two or more electrodes are coupled to the processor, the electrodes configured to deliver electrical stimulation to the gastrointestinal tract.

10. The system of claim 9, wherein the two or more electrodes are mounted along the body of the transgastric probe.

11. The system of claim 8, wherein the at least two sensors may be coupled to the processor and configured to generate signals and the processor may be configured to process the signals so as to identify transient changes in the gastric pouch of the gastrointestinal tract.

12. The therapeutic implant of claim 8, wherein the implant body has a first configuration and a second configuration, the size, compliance, or shape of the implant body in the second configuration being different than the size, compliance, or shape of the implant body in the first configuration such that the implant body has an enhanced inhibition of ingestion in the second configuration.

13. A method for treating an obese 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;

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

wherein the at least three sensors of the deployed implant include a transgastric probe having a probe body and a transgastric wall traversing portion, the sensor separated along the probe body from the wall traversing portion so as to be disposed within an interior of the gastrointestinal tract;

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.

14. The method of claim 13, wherein the transgastric probe may include two or more members selected from the group consisting of a temperature sensor, an electrode, and a visible color sensor and/or an infrared light detector.

15. The method of claim 13 further comprising:

communicating feedback to the patient, a peer group member, a health care professional, and/or a lifestyle coach, wherein the feedback is based on the determination of whether the ingested material constitutes an unhealthy ingestion or an allowed ingestion.

16. The method of claim 15, wherein communicating feedback provides a behavioral modification component for treating the obese patient.

17. The method of claim 13, wherein the feedback is communicated securely via website, email, telephone, or text message.

18. A therapeutic implant system for treating an overweight patient, the patient having a gastrointestinal tract and an unhealthy ingestion pattern, the therapeutic implant system comprising:

an ingestion restricting implant body deployable along the gastrointestinal tract so as to separate the gastrointestinal tract into different portions;

wherein the implant comprises a first gastric band and a second gastric band;

the first gastric band located superior relative to the second gastric band, each gastric band defining a channel through the gastrointestinal tract;

wherein the first gastric band comprises a fluid-filled pressure bladder disposed between the channel and a support structure such that changes in a fluid pressure within the bladder correspond with changes in an engagement force between the gastrointestinal tract and the first gastric band;

at least two sensors coupleable to the first and/or second gastric bands, the sensors capable of generating signals in response to transient changes in the gastrointestinal tract indicative of an ingestion event;

a processor coupled to a signal generator and the implant body;

a display coupled to the processor, the display showing ingestion events identified in response to the signals during a plurality of days and configured for communicating feedback to the patient, a peer group member, a health care professional, or a lifestyle coach;

an actuator coupled to the processor so as to alter the fluid pressure within the bladder in response to the ingestion event; and

at least two electrodes coupled to the processor so as to stimulate tissue of the gastrointestinal tract such that, in response to the signals, the unhealthy ingestion pattern of the patient is inhibited in use sufficiently to modify the unhealthy ingestion pattern toward a healthier ingestion pattern.

19. The system of claim 18, wherein the first gastric band increases fluid pressure in response to a sensed unhealthy ingestion pattern so as to discourage the ingestion event and restrict food intake.

20. The system of claim 18, wherein stimulating the tissue of the gastrointestinal tract curbs the patient'"'"'s appetite.

21. The system of claim 18, wherein each gastric band has different elasticities and each elasticity may be dynamically adjusted.

22. The system of claim 18, wherein the first and/or second gastric bands are secured in place with seromuscular sutures.