FEEDBACK SYSTEMS AND METHODS TO ENHANCE OBSTRUCTIVE AND OTHER OBESITY TREATMENTS

• US 20110034760A1
• Filed: 04/05/2010
• Published: 02/10/2011
• Est. Priority Date: 04/03/2009
• Status: Abandoned Application

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Province, Rose, Imran, Mir, Brynelsen, Charles R.
• Application Number:
  US12/754,439
• Publication Number:
  US 20110034760A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4205 Evaluating swallowing
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G09B 19/0092 Nutrition
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Feedback systems and methods enhance obstructive and other obesity treatments by presenting feedback regarding patients'"'"' actual eating and/or exercise habits. 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 or an intragastric balloon. Sensor signals may be processed to identify ingestion and/or characterize ingestion of a solid or a liquid, and the results may be displayed on a screen for a patient or coach to view.

Claims

1. A method for treating a patient, the patient having a gastrointestinal tract and an unhealthy ingestion pattern, the method comprising:

deploying an ingestion restricting implant body along the gastrointestinal tract;

generating signals correlating to altering of the implant body; and

inhibiting unhealthy ingestion by the patient in response to the signals sufficiently to modify the unhealthy ingestion pattern toward a healthier ingestion pattern.

2. The method of claim 1, wherein deploying the implant body comprises bariatric surgery so as to surgically implant an implant system for weight loss, the implant system comprising the implant body and a processor coupled to the implant body so as to transmit the signals therebetween.

3. The method of claim 2, wherein the implant body comprises a gastric band defining a channel therethrough, wherein deploying the implant body comprises positioning the band so that the gastrointestinal tract extends through the channel of the implant body.

4. The method of claim 3, wherein the altering of the implant body is performed a plurality of times each day for a plurality of days by altering an engagement force between the gastrointestinal tract and a fluid-filled pressure bladder of the gastric band, the fluid pressure bladder disposed between the channel and a support structure of the gastric band.

5. The method of claim 4, wherein the altering of the engagement force is induced each day by ingestion-related distension of the gastrointestinal tract within the channel of the gastric band, wherein the signals are generated by at least one sensor in response to transient changes in fluid pressure within the bladder, the signals indicating an ingestion event, and wherein the inhibiting of unhealthy ingestion comprises at least one member selected from the group consisting of:

showing a display to the patient or a lifestyle coach, the display corresponding to eating events during the plurality of days;

increasing the pressure within the bladder; and

/or

electrically stimulating tissue of the gastrointestinal tract with the implant.

6. The method of claim 5, wherein the at least one sensor comprises one of a pressure sensor, a temperature sensor, an optical sensor, an impedance sensor, a pH sensor, or an acoustic sensor.

7. The method of claim 6, wherein the ingestion event comprises ingestion of a solid.

8. The method of claim 6, wherein the ingestion event comprises ingestion of a drink.

9. The method of claim 4, wherein the signals comprise pressure command signals transmitted to the bladder from the processor of the implant, and wherein the altering of the engagement force is induced by changes in fluid pressure within the bladder in response to the pressure command signals so that the pressure within the bladder is decreased each day to allow healthy ingestion and increased each day to inhibit unhealthy ingestion.

10. The method of claim 3, wherein the processor is coupled to an actuator of the gastric band, and wherein altering the implant comprises varying a size or shape of the channel of the gastric band with the actuator in response to signals from the processor such that restriction of ingestion is altered.

11. The method of claim 10, wherein the actuator comprises a fluid actuator.

12. The method of claim 10, further comprising energizing the actuator with the signals so as to activate the gastric band and increase restriction and decrease ingestion into the patient.

13. The method of claim 10, further comprising energizing the actuator with the signals so as to deactivate the gastric band and decrease restriction and allow increased ingestion into the patient.

14. The method of claim 2, wherein the implant body comprises a gastric balloon, and wherein the processor is coupled to an actuator, and wherein altering the implant comprises varying a size of the gastric balloon with the actuator in response to the signals from the processor such that restriction of ingestion is altered.

15. The method of claim 2, wherein the implant body comprises a gastric balloon, wherein the altering of the implant body comprises altering a fluid pressure within the gastric balloon.

16. The method of claim 2, further comprising delivering electrical stimulation to an internal organ of the living body from the implant.

17. The method of claim 2, further comprising sensing a physiological trigger with the implant, wherein the processor transmits the signals in response to the physiological trigger.

18. The method of claim 11, wherein the processor transmits the signals at least in part in response to a non-physiological trigger.

19. The method of claim 1, wherein generating of the signals correlating to altering of the implant body is performed by a pressure sensor coupled to the implant body such that the signals identify pressure changes in the gastrointestinal tract, and further comprising processing the signals so as to identify an ingestion event, the inhibiting of the unhealthy ingestion being performed in response to the identification of the unhealthy ingestion event.

20. The method of claim 19, wherein the processing of the signals is performed so as to identify peristaltic waves of the gastrointestinal tract proximate to the ingestion restricting implant body.

21. The method of claim 19, further comprising characterizing the ingestion event as ingestion of a liquid in response to a pressure change that lasts more than 10 seconds but less than 5 minutes.

22. The method of claim 19, further comprising characterizing the ingestion event as ingestion of a solid in response to a pressure change that lasts more than 5 minutes but less than 60 minutes.

23. The method of claim 19, further comprising sensing a temperature signal proximate the gastrointestinal tract with a temperature sensor, wherein the processing of the signals comprises processing of the signals from the pressure sensor and temperature signals from the temperature sensor by a processor so as to characterize the ingestion event, the inhibiting of the unhealthy ingestion being performed in response to the characterizing of the ingestion event.

24. The method of claim 24, wherein the characterizing the ingestion event comprises identifying ingestion of a solid in response to a sufficiently high pressure change and sufficiently low temperature change.

25. The method of claim 24, wherein the characterizing the ingestion event comprises identifying combined solid and liquid ingestion in response to a sufficiently high pressure change and sufficiently high temperature change.

26. The method of claim 24, wherein sufficiently low pressure change and sufficiently low temperature change are identified as no ingestion.

27. The method of claim 24, wherein the characterizing the ingestion event comprises identification of a liquid ingestion and possible cheating event in response to sufficiently low pressure change and sufficiently high temperature change.

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

deploying an ingestion restricting implant along the gastrointestinal tract;

sensing, with the implant, an ingestion into the patient;

transmitting, from the implant, signals in response to the ingestion; and

at least one member selected from the group consisting of;

displaying ingestion information and

treating the patient

per the signals.

29. The method of claim 28, wherein the deploying of the implant comprising positioning the implant so that a tissue of the gastrointestinal tract extends through a channel of the implant such that a size of the channel limits transmission of ingested material along the gastrointestinal tract from upstream of the implant to downstream of the implant.

30. The method of claim 29, wherein the deploying of the implant comprises a laparoscopic gastric band placement procedure.

31. The method of claim 28, wherein deploying the implant comprises positioning the implant within an interior of the stomach, the implant having a sufficient food displacement volume to significantly limit ingestion.

32. The method of claim 32, wherein the implant comprises a gastric balloon.

33. 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 and a processor;

identifying, during a day, an allowed ingestion, and allowing associated ingested material to traverse the body of the implant along the gastrointestinal tract;

identifying, during the day, an unhealthy ingestion; and

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.

34. The method of claim 33, wherein the deploying of the implant comprising positioning the implant so that a tissue of the gastrointestinal tract extends through a channel of the implant such that a size of the channel limits transmission of ingested material along the gastrointestinal tract from upstream of the implant to downstream of the implant.

35. The method of claim 34, wherein the deploying of the implant comprises a laparoscopic gastric band placement procedure.

36. The method of claim 33, wherein deploying the implant comprises positioning the implant within an interior of the stomach, the implant having a sufficient food displacement volume to significantly limit ingestion.

37. The method of claim 36, wherein the implant comprises a gastric balloon.

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

deploying an implant along the gastrointestinal tract, the implant having a processor and a body;

identifying, during a day, an unhealthy ingestion; and

transmitting signals from the processor to the patient in response to the identification of the unhealthy ingestion so as to inhibit the unhealthy ingestion.

39. 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 deployable along the gastrointestinal tract;

a signal generator coupled to the implant body so as to generate signals correlating to altering of the implant body; and

a processor coupled to the signal generator 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.

40. The system of claim 39, wherein the implant body comprises a gastric band defining a channel therethrough, the gastrointestinal tract extendible 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.

41. The system of claim 40, wherein the signal generator comprises at least one sensor coupled to the fluid pressure bladder, the altering of the engagement force induced by ingestion-related distension of the gastrointestinal tract within the channel of the gastric band so that the signals are generated in response to transient changes in fluid pressure within the bladder and the signals indicate an ingestion event.

42. The system of claim 41, further comprising at least one of:

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 to the patient 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

an electrode coupled to the processor so as to stimulate tissue of the gastrointestinal tract in response to the ingestion event.

43. The system of claim 42, further comprising at least one of a pressure sensor, a temperature sensor, an optical sensor, an impedance sensor, a pH sensor, or an acoustic sensor coupled to the processor.

44. The system of claim 40, wherein the signal generator comprises an actuator, the signals comprising fluid pressure signals transmitted to the bladder from the processor, and wherein the altering of the engagement force is induced by changes in fluid pressure within the bladder in response to the pressure signals so that the pressure within the bladder is decreased each day to allow healthy ingestion and increased each day to inhibit unhealthy ingestion.

45. The system of claim 44, wherein energizing the actuator activates the gastric band so as to increase restriction and decrease ingestion into the patient.

46. The system of claim 44, wherein energizing the actuator deactivates the gastric band so as to decrease restriction and allow increased ingestion into the patient.

47. The system of claim 39, wherein the implant body comprises a gastric balloon, wherein the altering of the implant body comprises altering a fluid pressure within the gastric balloon.

48. The system of claim 47, wherein the signal generator comprises an actuator, and wherein altering the implant comprises varying a size of the gastric balloon with the actuator in response to command signals from the processor such that restriction of ingestion is altered.

49. The system of claim 39, further comprising an electrode coupled to the processor so as to deliver electrical stimulation to an internal organ of the living body.

50. The system of claim 49, wherein the signal generator comprises a pressure sensor, and wherein the processor is configured to process the signals to as to identify pressure changes in the gastrointestinal tract.

51. The system of claim 50, wherein the processor is configured so that a pressure change that lasts at least 10 seconds but not more than 5 minutes is identified as an ingestion of a liquid.

52. The system of claim 50, wherein the processor is configured so that a pressure change that lasts at least 5 minutes but not more than 60 minutes is identified as an ingestion of a solid.

53. The system of claim 39, further comprising a temperature sensor coupled to the processor so as to provide a temperature from proximate the gastrointestinal tract thereto.

54. The system of claim 53, wherein the processor is configured so that signals from the pressure sensor and temperature sensor are processed to identify pressure changes and temperatures.

55. The system of claim 54, wherein the processor is configured so that high pressure change and low temperature change is identified as a solid ingestion.

56. The system of claim 54, wherein the processor is configured so that high pressure change and high temperature change is identified as a combined solid and liquid ingestion.

57. The system of claim 54, wherein the processor is configured so that low pressure change and low temperature change is identified as no ingestion.

58. The system of claim 54, wherein the processor is configured so that low pressure change and low temperature change is identified as a liquid ingestion and possible cheating event.

59. The system of claim 39, further comprising a sensor coupled to the processor, wherein the sensor comprises an optical sensor.

60. A system for treating a patient, the patient having a gastrointestinal tract, the system comprising:

an ingestion restricting implant body deployable along the gastrointestinal tract;

a sensor coupled to the implant body so as to transmit signals in response to ingestion into the patient in use; and

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

ingestion display signals, and

patient treatment signals.

61. A system for treating a patient, the patient having a gastrointestinal tract, the system comprising:

an implant body deployable along the gastrointestinal tract;

a processor; and

an actuator coupling the processor to the body;

the processor configured so as to identify, during a day, an allowed ingestion, and for allowing associated ingested material to traverse the body of the implant along the gastrointestinal tract;

the processor configured so as to identify, during the day, an unhealthy ingestion and to transmit signals to the body via the actuator so as to alter a shape or size of the body such that the body restricts the unhealthy ingestion.

62. 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; and

a processor coupleable to the implant body so as to transmit signals therebetween, wherein the signals are transmitted in correlation with changes in a size or a shape of the implant body in use.

63. The therapeutic implant of claim 62, 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.

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

an ingestion restricting implant body implantable along the gastrointestinal tract;

at least one sensor for generating signals; and

a processor coupled to the at least one sensor and the implant body so as to transmit the signals therebetween, wherein the signals are transmitted in correlation with an ingestion event.

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

an ingestion restricting implant body implantable along the gastrointestinal tract;

at least one sensor for generating signals; and

a processor coupleable to the at least one sensor and the implant body so as to transmit the signals therebetween, wherein the signals are transmitted in correlation with a physical activity event.

66. The therapeutic implant of claim 65, wherein the sensor comprises an activity sensor.

67. The therapeutic implant of claim 65, wherein the sensor comprises a heart rate sensor.

68. The therapeutic implant of claim 65, wherein the sensor comprises a core body temperature sensor.

69. The therapeutic implant of claim 65, wherein the sensor comprises a sleep detector.

70. The therapeutic implant of claim 65, wherein the signals are transmitted by the processor to a data server.