Gastrointestinal electrical therapy

• US 8,934,975 B2
• Filed: 02/01/2011
• Issued: 01/13/2015
• Est. Priority Date: 02/01/2010
• Status: Active Grant

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Haddad, Walid, Goode, Paul V. Jr., Lebovitz, Harold, Rousso, Benny, Ben-Haim, Shlomo, Yaniv, Irit, Aviv, Ricardo
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US13/576,485
• Publication Number:
  US 20130030503A1
• Time in Patent Office: 1,442 Days
• Field of Search: 607/2, 607/9, 607/40
• US Class Current: 607/40
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Apparatus (18) for treating a human patient, which includes one or more electrode contact surfaces (100), which are configured to be applied to a fundus (22) of the patient. A control unit (90) is configured to drive the one or more electrode contact surfaces (100) to apply an electrical signal to the fundus (22) that chronically improves a blood glucose level of the patient, in order to treat the patient, without calculating an impedance of tissue of the fundus (22) based on a sensed parameter that varies in response to the electrical signal, for detecting eating by the patient or a characteristic of food eaten by the patient. Other embodiments are also described.

Claims

1. A method for treating a human patient, comprising:

implanting one or more electrode contact surfaces in contact with a fundus of the patient;

providing a control unit coupled to the electrode contact surfaces; and

activating the control unit to drive the electrode contact surfaces to apply an electrical signal to at least one fundic site of the patient that chronically improves a blood glucose level of the patient, in order to treat the patient, (a) without sensing eating by the patient, and (b) without detecting a characteristic of food eaten by the patient by calculating an impedance of tissue of the fundus based on a sensed parameter that varies in response to the electrical signal.

2. The method according to claim 1, wherein activating comprises configuring the control unit to apply the signal to the at least one fundic site at least intermittently during a period having a duration of at least one week, without applying any electrical signals to any antral, sites of the patient during the period.

3. The method according to claim 1, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from hypertension, and implanting and activating in response to the identifying.

4. The method according to claim 1, wherein activating the control unit comprises activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient, without the control unit applying, or generating a signal for applying, any additional glucose-control or weight-control therapy to the patient.

5. A method for treating a human patient, comprising:

identifying that the patient might experience a chronic improvement in a blood glucose level in response to application of an electrical signal to at least one fundic site of the patient; and

in response to identifying;

implanting one or more electrode contact surfaces in contact with a fundus of the patient;

providing a control unit coupled to the electrode contact surfaces; and

activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient, without sensing eating by the patient.

6. The method according to claim 5, wherein implanting the one or more electrode contact surfaces in contact with the fundus of the patient comprises:

endoseopically making one or more incisions through a fundic wall of the patient; and

via exactly one of the one or more incisions, implanting the one or more electrode contact surfaces in contact with the fundus of the patient.

7. The method according to claim 6, wherein providing the control unit comprises implanting the control unit in a body of the patient via the exactly one of the one or more incisions.

8. The method according to claim 7, wherein providing the control unit comprises providing the control unit sized such that at least one line that passes from edge to edge of the control unit through the center of gravity thereof has a length of no more than 2 cm.

9. The method according to claim 8, wherein the length is no inure than 1 cm.

10. The method according to claim 6, wherein making the one or more incisions and implanting comprise making the one or more incisions and implanting during a surgical implantation procedure having a duration of no more than 45 minutes.

11. The method according to claim 5,

wherein activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the, patient comprises activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient during signal-application periods, and

further comprising activating the control unit to provide reduced-signal-application periods, which alternate with the signal-application periods, and during which the electrode contact surfaces apply the electrical signal having an average energy current that is less than 20% of the average energy of the electrical signal applied during the signal-application periods,

wherein the control unit provides one or more of the reduced-signal-applications periods during every 24-hour period, each of which reduced-signal-application periods has a duration of at least 30 minutes.

12. The method according to claim 11, wherein the reduced-signal-application periods are non-signal-application periods, and wherein activating comprises configuring the control unit to withhold applying the electrical signal during the non-signal-application periods.

13. The method according to claim 5, wherein activating the control unit comprises activating the control unit to drive the one or more electrode contact surfaces using no more than 5 J over a 24-hour period.

14. The method according to claim 5, wherein implanting the one or more electrode contact surfaces comprises implanting exactly one implantable electrode structure that includes the one or more electrode contact surfaces.

15. The method according to claim 5, wherein implanting the one or more electrode contact surfaces comprises implanting the one or more electrode contact surfaces in physical contact with muscle tissue of the fundic site.

16. The method according to claim 15, wherein implanting the one more electrode contact surfaces comprises positioning the one or more electrode contact surfaces within the muscle tissue.

17. The method according to claim 5, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from diabetes, and implanting and activating in response to the identifying

18. The method according to claim 5, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from metabolic syndrome, and implanting and activating in response to the identifying.

19. The method according to claim 5, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient might experience an improvement in the blood glucose level in response to applying the signal, and implanting and activating in response to identifying.

20. The method according to claim 5, wherein activating comprises configuring one or more parameters of the electrical signal to cause a reduction in a fasting glucose blood level of the patient.

21. The method according to claim 5, wherein activating comprises configuring one or more parameters of the electrical signal to cause a reduction in postprandial glucose level of the patient.

22. The method according to claim 5, wherein activating comprises configuring one or more parameters of the electrical signal to cause an improvement in a level at least one hormone selected from the group consisting of:

at least one hormone associated with glycemic control, and at least one hormone associated with a metabolic disorder.

23. The method according to claim 22, further comprising assessing the level of the at least one hormone after activating the control unit.

24. The method according to claim 22, wherein the improvement in the level of the at least one hormone includes a normalization of at least one element selected from the group consisting of:

secretion of the at least one hormone, expression of the at least one hormone, and a blood level of the at least one hormone.

25. The method according to claim 22, wherein configuring comprises configuring the one or more parameters of the electrical signal to simultaneously cause the improvement in levels of a plurality of hormones.

26. The method according to claim 22, wherein the at least one hormone is secreted by a stomach of the patient.

27. The method according to claim 26, wherein the at least one hormone is secreted by the fundus.

28. The method according to claim 26, wherein the at least one hormone is secreted by an antrum of the stomach.

29. The method according to claim 22, wherein the at least one hormone is secreted by an organ of the patient selected from the group of organs consisting of:

a duodenum of the patient, and a pancreas of the patient.

30. The method according to claim 22, wherein the improvement is an improvement selected from the group of improvements consisting of:

improvement in a postprandial level of the at least one hormone, and an improvement in a fasting level of the at least one hormone.

31. The method according claim 30, wherein the improvement includes an improvement selected from the group of improvements consisting of:

an improvement in a postprandial level of insulin, and an improvement in a fasting level of insulin.

32. The method according to claim 30, wherein the improvement includes an improvement selected from the group of improvements consisting of:

an improvement in a postprandial level of ghrelin, an improvement in a fasting level of ghrelin, an improvement in a postprandial level of glucagon, an improvement in a postprandial level of pancreatic polypeptide, an improvement in a fasting level of pancreatic polypeptide, an improvement in a postprandial level of glucagon-like peptide-1 (GLP-1), and an improvement in a postprandial level of C-peptide.

33. The method according to claim 5, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient might experience an improvement in a level at least one hormone in response to applying the signal, and implanting and activating in response to identifying, wherein the at least one hormone is selected from the group consisting of:

at least one hormone associated with glycemic control, and at least one hormone associated with a metabolic disorder.

34. The method according to claim 33, wherein the improvement in the level of the at least one hormone includes a normalization of at least one element selected from the group consisting of:

secretion of the at least one hormone, expression of the at least one hormone, and a blood level of the at least one hormone.

35. The method according to claim 33, wherein the improvement is a simultaneous improvement in levels of a plurality a hormones.

36. The method according to claim 33, wherein the at least one hormone is secreted by an organ of the patient selected from the group of organs consisting of:

a stomach of the patient, the fundus, an antrum of the stomach, a duodenum of the patient, and a pancreas of the patient.

37. The method according to claim 33, wherein the improvement is an improvement selected from the group of improvements consisting of:

an improvement in a postprandial level of the at least one hormone, and an improvement in a listing level of the at least one hormone.

38. The method according to claim 33, wherein the improvement includes an improvement selected from the group of improvements consisting of:

an improvement in a postprandial level of insulin, and an improvement in a fasting level of insulin.

39. The method according to claim 37, wherein the improvement includes an improvement selected from the group a improvements consisting of:

an improvement in a postprandial level of ghrelin, an improvement in a fasting level of ghrelin, an improvement in a postprandial level of glucagon, an improvement in a postprandial level of pancreatic polypeptide, an improvement in a fasting level of pancreatic polypeptide, an improvement in a postprandial level of glucagon-like peptide-1 (GLP-1) and an improvement in a postprandial level of C-peptide.

40. The method according to claim 5, further comprising assessing blood glucose level control by measuring a level of HbA1c of the patient after activating the control unit.

41. The method according to claim 5, further comprising assessing blood glucose level improvement by measuring the blood glucose level after activating the control unit.

42. The method according to claim 5, wherein activating comprises configuring one or more parameters of the electrical signal to not cause hypoglycemia of the patient.

43. The method according to claim 42, wherein configuring the one or more parameters of the electrical signal to not cause the hypoglycemia does not comprise measuring the blood glucose level of the patient.

44. The method according to claim 5, wherein activating comprises configuring the control unit to apply the signal in a series of pulses having an energy per pulse of no more than 5 microjoules.

45. The method according to claim 5, wherein activating comprises configuring the control unit to apply the signal in a series of pulses having an average energy per pulse of no more than 5 microjoules.

46. The method according to claim 5, wherein activating comprises configuring the control unit to apply the signal having an instantaneous power of no more than 100 milliwatts.

47. The method according to claim 5, wherein activating comprises configuring the control unit to apply the signal in a series of pulses, at least one of which pulses has an amplitude of between 5 mA and 35 mA.

48. The method according to claim 5, wherein activating comprises configuring the control unit to apply the signal for at least three months.

49. The method according to claim 5, wherein activating the control unit comprises activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient, without detecting a characteristic of food eaten by the patient by calculating an impedance of tissue of the fundus based on a sensed parameter that varies in response to the electrical signal.

50. The method according to claim 5, wherein activating the control unit comprises activating the control unit to:

during first and second modes of operation, drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient, and configuring one or more parameters of the electrical signal to chronically improve the blood glucose level of the patient, in order to heat the patient, and

during the first mode, and not during the second mode, sense a parameter that varies in response to the applied electrical signal, and calculate, based on the sensed parameter, an impedance of tissue of the fundus.

51. The method according to claim 5, wherein activating the control unit comprises activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient, without the control unit applying, or generating a signal for applying, any additional glucose-control or weight-control therapy to the patient.

52. The method according to claim 5, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from hypertension, and implanting and activating in response to the identifying.

53. A method for treating a human patient, comprising:

identifying that the patient might experience a chronic improvement in a blood glucose level in response to application of an electrical signal to at least one fundic site of the patient; and

in response to identifying;

implanting one or more electrode contact surfaces in contact with a fundus of the patient;

providing a control unit coupled to the electrode contact surfaces; and

activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient,

wherein activating comprises configuring the control unit to (a) apply the signal in a series of pulses, at least one of which pulses has a duration of no more than 5 milliseconds, and (b) configure the pulses to have an average energy per pulse of no more than 50 microjoules.

54. The method, according to claim 53, wherein the duration is between 2 microseconds and 5 milliseconds.

55. The method according to claim 53, wherein the duration is no more than 1 millisecond.

56. The method according to claim 55, wherein the duration is no more than 100 microseconds.

57. The method according to claim 53, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from hypertension, and implanting and activating in response to the identifying.

58. A method for treating a human patient, comprising;

implanting one or more electrode contact surfaces in contact with a fundus of the patient;

providing a control unit coupled to the electrode contact surfaces; and

activating the control unit to drive the electrode contact surfaces to apply an electrical signal, as a plurality of pulses, to at least one fluidic site of the patient that chronically improves a blood glucose level of the patient, in order to treat the patient, (a) without detecting eating by the patient by calculating impedance of tissue of the fundus based on a sensed parameter that varies in response to the electrical signal, and (b) without detecting a characteristic of food eaten by the patient by calculating impedance of tissue of the fundus based on a sensed parameter that varies in response to the electrical signal,

wherein one or more of the pulses have a pulse width of no more than 5 milliseconds.

59. The method according to claim 58, wherein the duration is between 2 microseconds and 5 milliseconds.

60. The method according to claim 58, wherein the duration is no more than 1 millisecond.

61. The method according to claim 60, wherein the duration is no more than 100 microseconds.

62. The method according to claim 58, wherein activating comprises configuring the control unit to configure the pulses to have an average energy per pulse of no more than 50 microjoules.

63. The method according to claim 58, wherein activating comprises configuring the control unit to generate the electrical signal using no more than 5 J over a 24-hour period.

64. The method according to claim 58, wherein implanting the electrode contact surfaces and activating the control unit comprises identifying that the patient suffers from hypertension, and implanting and activating in response to the identifying.

65. A method for treating a human patient, comprising:

identifying that the patient might experience a chronic improvement in a blood glucose level in response to application of an electrical signal to at least one fundic site of the patient; and

in response to identifying;

implanting one or more electrode contact surfaces in contact with a fundus of the patient;

providing a control unit coupled to the electrode contact surfaces; and

activating the control unit to drive the electrode contact surfaces to apply the electrical signal to the at least one fundic site of the patient that chronically improves the blood glucose level of the patient, in order to treat the patient,

wherein activating the control unit comprises (a) configuring the control unit to apply the signal in series of pulses, at least one of which pulses has a duration of no more than 5 milliseconds, and (b) activating the control unit to drive the one or more electrode contact surfaces using no more than 5 J over a 24-hour period.

66. The method according to claim 65, wherein activating comprises configuring the control unit to configure the pulses to have an average energy per pulse of no more than 50 microjoules.