Non-immediate effects of therapy

• US 9,821,158 B2
• Filed: 08/10/2015
• Issued: 11/21/2017
• Est. Priority Date: 02/17/2005
• Status: Expired due to Fees

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Rousso, Benny, Harel, Tamar
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US14/821,848
• Publication Number:
  US 20150343212A1
• Time in Patent Office: 834 Days
• 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

Abstract

A method of treating a metabolic condition in a patient, comprising:

• • determining a target non-immediate effect of a therapy relating to treatment of a metabolic condition; and
  • applying an electric field to an abdominal cavity of the patient in a manner designed to at least approach said target.

Claims

1. A method of treating a diabetic patient comprising:

receiving a BMI and HbA1c level of said diabetic patient;

selecting said patient for treatment with an insulin-resistance reducing signal, according to said BMI being above a BMI threshold, and said HbA1c level being above a HbA1C threshold; and

applying said treatment to said selected patient, said treatment comprising at least one of intra-abdominal and gastric electrical stimulation, thereby reducing an insulin resistance of said patient beyond any reduction which may be caused solely by weight loss, if any, due to said treatment;

wherein said applying causes said patient to generate less insulin for a same amount of food ingested, after said therapy is applied for a month, even if ingested after a pause in therapy of a week,

wherein said applying comprises using a signal which is non-excitatory to gastric muscle when applied to said gastric muscle.

2. A method according to claim 1, wherein said treatment has an immediate effect of reducing insulin secretion in response to food intake.

3. A method according to claim 2, wherein said reduction comprises a reduction in peak insulin levels in blood.

4. A method according to claim 1, comprising also injecting insulin to said patient.

5. A method according to claim 1, comprising also restricting a diet of said patient.

6. A method according to claim 1, comprising modifying said treatment of said patient in response to a change in insulin resistance caused by said applying.

7. A method according to claim 1, comprising providing insulin secretion enhancing drugs to said patient in response to a change in insulin resistance caused by said applying.

8. A method according to claim 1, comprising reducing one or both of insulin and drugs providing to said patient for treating diabetes, by at least 50%, in response to a change in insulin resistance caused by said applying within 4 weeks of starting said applying.

9. A method according to claim 1, comprising reducing one or both of insulin and drugs providing to said patient for treating diabetes, by at least 50%, in response to a change in insulin resistance caused by said applying within 10 weeks of starting said applying.

10. A method according to claim 1, comprising detecting a reduction in insulin resistance caused by said applying within 10 weeks of starting said applying.

11. A method according to claim 1, wherein said BMI threshold is at least 30.

12. A method according to claim 1, wherein said BMI threshold is at least 32.

13. A method according to claim 1, wherein said applying comprises applying gastric stimulation.

14. A method according to claim 13, wherein said signal is applied to an antrum, in response to an indication of eating.

15. A method according to claim 1, wherein said signal is applied as a series of bi-phasic pulses, wherein each phase is about 6 ms long and has a current of less than 10 mA.

16. A method according to claim 1, wherein said applying is automatic.

17. A method according to claim 1, wherein said applying is in response to an eating indication.

18. A method according to claim 1, wherein said applying comprises applying electrical stimulation with a frequency between 20 and 200 Hz.

19. A method according to claim 1, wherein said applying comprises applying electrical stimulation with a frequency between 50 and 150 Hz.

20. A method according to claim 1, wherein said applying comprises applying electrical stimulation with a magnitude between 2 and 15 mA.

21. A method according to claim 1, wherein said applying comprises applying electrical stimulation timed to a gastric slow wave.

22. A method according to claim 1, wherein said applying comprises applying a pulse train having a duration of between 1 and 6 seconds.

23. A method according to claim 1, wherein said applying comprises applying a pulse train having pulses with a duration of a pulse phase of between 1 and 10 milliseconds.

24. A method of treating a diabetic patient, comprising:

receiving a BMI level of said patient;

selecting said diabetic patient for treatment with an insulin-resistance reducing signal, according to said BMI being above a BMI threshold; and

applying an electrical signal to said patient, said signal comprising at least one of intra-abdominal and gastric electrical stimulation, said signal selected to reduce elevated glucose levels in said patient and selected to reduce insulin resistance of said patient, thereby reducing an insulin resistance of said patient beyond any reduction which may be caused solely by weight loss, if any, due to said treatment;

wherein said applying causes said patient to generate less insulin for a same amount of food ingested, after said therapy is applied for a month, even if ingested after a pause in therapy of a week,

wherein said electrical signal has a frequency between 30 Hz and 200 Hz.

25. A method according to claim 24, wherein said patient has a BMI above 30.

26. A method according to claim 24, wherein said patient has a BMI above 35.

27. A method according to claim 24, wherein said patient is morbidly obese.

28. A method according to claim 24, wherein said applying comprises selecting a signal selected to cause feelings of satiety.

29. A method according to claim 24, wherein said signal is selected to reduce insulin resistance beyond any reduction which may be caused solely by weight loss, if any, caused by the signal.

30. A method of treating a pre-diabetic obese patient, comprising:

receiving a BMI level of said patient;

selecting said pre-diabetic patient for treatment with an insulin-resistance reducing signal, according to said BMI being above a BMI threshold and having difficult in exercising and not being diabetic; and

applying an electrical signal to said patient, said signal comprising at least one of intra-abdominal and gastric electrical stimulation, said signal selected to reduce elevated glucose levels in said patient and selected to reduce insulin resistance of said patient, thereby reducing an insulin resistance of said patient beyond any reduction which may be caused solely by weight loss, if any, due to said treatment;

wherein said applying causes said patient to generate less insulin for a same amount of food ingested, after said therapy is applied for a month, even if ingested after a pause in therapy of a week,

wherein said electrical signal has a magnitude of between 2 mA and 15 mA.

31. A method according to claim 30, wherein said applying also has an immediate effect of reducing a reactivity of the pancreas to food ingestion by reducing an insulin peak amplitude in response to food ingestion.

32. A method according to claim 30, wherein said applying comprises selecting a signal selected to cause feelings of satiety.

33. A method according to claim 30, wherein said signal is selected to reduce insulin resistance beyond any reduction which may be caused solely by weight loss, if any, caused by the signal.

34. A method of treating a diabetic or pre-diabetic patient comprising:

receiving a BMI and HbA1c level of said diabetic patient;

selecting said patient for treatment with an insulin-resistance reducing signal, according to said BMI being above a BMI threshold, and said HbA1c level being above a HbA1C threshold; and

applying said treatment to said selected patient, said treatment comprising at least one of intra-abdominal and gastric electrical stimulation, thereby reducing an insulin resistance of said patient beyond any reduction which may be caused solely by weight loss, if any, due to said treatment;

wherein said applying causes said patient to generate less insulin for a same amount of food ingested, after said therapy is applied for a month, even if ingested after a pause in therapy of a week,

wherein said applying is timed relative to gastric slow waves.

35. A method of treating a diabetic patient, comprising:

receiving a BMI level of said patient;

selecting said diabetic patient for treatment with an insulin-resistance reducing signal, according to said BMI being above a BMI threshold; and

applying an electrical signal to said patient, said signal comprising at least one of intra-abdominal and gastric electrical stimulation, said signal selected to reduce elevated glucose levels in said patient and selected to reduce insulin resistance of said patient, thereby reducing an insulin resistance of said patient beyond any reduction which may be caused solely by weight loss, if any, due to said treatment;

wherein said applying causes said patient to generate less insulin for a same amount of food ingested, after said therapy is applied for a month, even if ingested after a pause in therapy of a week,

wherein said applying comprises using a signal which is non-excitatory to gastric muscle when applied to said gastric muscle.

36. A method according to claim 35, wherein said patient has a BMI above 30.

37. A method according to claim 35, wherein said applying comprises applying electrical stimulation with a frequency between 20 and 200 Hz.

38. A method according to claim 35, wherein said applying comprises applying electrical stimulation with a magnitude between 2 and 15 mA.