Non-immediate effects of therapy

• US 9,101,765 B2
• Filed: 02/16/2006
• Issued: 08/11/2015
• Est. Priority Date: 03/05/1999
• 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:
  US11/884,389
• Publication Number:
  US 20090131993A1
• Time in Patent Office: 3,463 Days
• Field of Search: 607/40, 607/59, 607/2
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

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 metabolic condition in a patient, comprising:

determining a target non-immediate effect of a therapy relating to treatment of a metabolic condition, said target including a reduced fasting glucose level identifiable 24 hours after said applying is stopped;

selecting an application protocol designed to at least approach said target;

applying an electric field to an abdominal cavity of the patient following said protocol so as to at least approach said target; and

causing said target to be approached by said applying, wherein said non-immediate effect is in addition to any effect caused by weight loss.

2. A method according to claim 1, wherein said metabolic condition comprises diabetes.

3. A method according to claim 1, wherein selecting comprises selecting at least one pulse application parameter of said field responsive to said determining.

4. A method according to claim 1, wherein selecting comprises selecting at least one application logic of said field responsive to said determining.

5. A method according to claim 1, wherein selecting comprises selecting at least one stopping condition of said field responsive to said determining.

6. A method according to claim 1, wherein selecting comprises selecting at least one application modification logic of said field responsive to said determining.

7. A method according to claim 1, wherein said non-immediate effect is an effect that appears after less than 1 week from starting of said applying.

8. A method according to claim 1, wherein said non-immediate effect is an effect that appears in a significant manner after more than 3 weeks from starting of said applying.

9. A method according to claim 8, wherein said effect includes a persistent reduced fasting blood glucose level.

10. A method according to claim 1, wherein said effect includes a reduction in HbA1c.

11. A method according to claim 1, wherein said selecting comprises selecting an application protocol also to achieve an acute effect.

12. A method according to claim 1, wherein said applying comprises applying an electric field as a sequence of at least one pulse and comprising applying said sequence fewer than 10 times a day.

13. A method according to claim 1, wherein said applying comprises applying an electric field as a sequence of at least one pulse and comprising applying said sequence fewer than 5 times a day.

14. A method according to claim 1, wherein said applying comprises applying an electric field as a sequence of at least one pulse and comprising applying said sequence in fewer than 3 days of a week of said applying.

15. A method according to claim 1, wherein said applying comprises applying an electric field as a sequence of at least one pulse and comprising applying said sequence such that a field is applied, in total, for less than 10 minutes a day.

16. A method according to claim 1, wherein said selecting comprises taking into account a treatment of said patient using a bioactive material.

17. A method according to claim 1, wherein said applying comprises applying to a pancreas.

18. A method according to claim 1, wherein said applying comprises applying to a GI tract.

19. A method according to claim 1, wherein said applying comprises applying to a stomach.

20. A method according to claim 1, wherein said target comprises a reduction in insulin resistance.

21. A method according to claim 1, wherein said target comprises an improvement in post-prandial glucose levels.

22. A method according to claim 1, wherein said applying comprises applying for less than 3 hours a day, on the average, for a month.

23. A method according to claim 1, wherein said applying comprises applying for less than 1 hour a day, on the average, for a month.

24. A method according to claim 1, wherein said applying comprises applying for less than 1 minute a day, on the average, for a month.

25. A method according to claim 1, wherein said non-immediate effect is an effect that is apparent in a significant manner after more than 1 week from completing of said applying and comprising measuring said effect.

26. A method according to claim 1, wherein said non-immediate effect is an effect that is apparent in a significant manner after more than 1 week from starting of said applying and comprising measuring said effect.

27. A method according to claim 1, comprising also determining an acute target for said treatment, wherein said applying is for both acute and non-immediate treatment targets and comprising measuring to determine if said targets are reached.

28. A method according to claim 1, wherein said non-immediate effect is identifiable within 4 weeks of an initiation of said therapy.

29. A method according to claim 1, wherein said non-immediate effect becomes more pronounced after stopping said applying and comprising measuring said effect.

30. A method according to claim 1, comprising modifying said applying in response to a measurement of said non-immediate effect.

31. Apparatus for treating a metabolic disorder, comprising:

at least one electrode adapted for implantation in an abdominal cavity; and

circuitry configured to apply an electrical signal, suitable for acute metabolic treatment of humans by reducing blood glucose levels, to said electrodes fewer than 3 hours a day, on the average for a month, wherein said configuration comprises a limit on application duration in a day.

32. Apparatus according to claim 31, wherein said configuration comprises programming.

33. Apparatus according to claim 31, wherein said limit is implemented, at least in part, by said circuitry enforcing a refractory period during which no field is applied after a previous application.

34. Apparatus according to claim 31, wherein said circuitry is configured to apply said field fewer than 10 minutes a day on the average for a week.

35. Apparatus according to claim 31, wherein said electric signal is selected to reduce glucose levels.

36. Apparatus according to claim 31, wherein said electric signal is selected to reduce glucose levels without significantly raising insulin levels.

37. Apparatus according to claim 31, wherein said electric signal is selected to cause a feeling of satiety.

38. Apparatus according to claim 31, wherein said circuitry is configured to apply an electrical signal to said electrodes less than 1 hours a day, on the average for a month.

39. Apparatus according to claim 31, wherein said circuitry is configured to apply an electrical signal to said electrodes less than 30 minutes a day, on the average for a month.

40. Apparatus according to claim 31, wherein said circuitry is configured to apply an electrical signal to said electrodes less than 20 minutes a day, on the average for a month.

41. Apparatus for treating a metabolic disorder, comprising:

at least one electrode adapted for implantation in an abdominal cavity; and

circuitry configured to apply an electrification signal, suitable for acute metabolic treatment of humans by reducing blood glucose levels, to said at least one electrode less than once a day on the average for at least a week, wherein said configuration comprises a limit on application duration in a day.

42. Apparatus according to claim 41, wherein said circuitry is configured to apply said signal for at least a month.

43. A method of metabolic treatment, comprising:

determining a desired diurnal day and night blood glucose level pattern which is not uniform over the day;

applying a blood chemical modifying electrical therapy in a pattern selected to at least approach said desired diurnal pattern by the application separately affecting day and night blood glucose levels.

44. A method of treating an early morning rise in blood glucose levels including one or both of a dawn effect and a Somogyi effect, comprising:

predicting an increase in blood glucose levels at a time prior to an expected waking time; and

applying an electric field to an abdominal cavity of a patient more than 2 hours before said expected waking time and prior to said predicted increase, said applying preventing or reducing such an increase in blood glucose level.

45. A method according to claim 44, wherein said field is applied at least 5 hours before waking.

46. A method for determining a suitability of a patient for treatment using electrical therapy, comprising:

applying at least one electrical field to the patient, said field at least putatively suitable for achieving a metalobic change of a non-immediate reduced fasting glucose level identifiable after 24 hours; and

determining a suitablility of said patient, based on at least one of (a) a change in response to a metabolic challenge given after the applying, said change caused by said field; and

(b) a non-immediate effect of said field measured at least 24 hours after said applying is stopped.

47. A method according to claim 46, wherein determining a suitability comprises determining a suitability based on a change in patient response.

48. A method according to claim 46, wherein determining a suitability comprises determining a suitability based on a non-immediate effect.

49. A method according to claim 48, wherein said non-immediate effect manifests within less than 3 days.

50. A method of treating a variation in blood glucose level, comprising:

predicting a change in blood glucose level based on a pattern of blood glucose levels; and

applying an electric field to an abdominal cavity of a patient more than 1 hour before a predicted increase in blood glucose levels, said applying preventing or reducing such an increase in blood glucose level.