Devices and methods for gynecologic hormone modulation in mammals

• US 20060079943A1
• Filed: 08/30/2005
• Published: 04/13/2006
• Est. Priority Date: 08/31/2004
• Status: Active Grant

• Current Assignee: Leptos Biomedical, Inc. (Abbott Laboratories)
• Original Assignee: Leptos Biomedical, Inc. (Abbott Laboratories)
• Inventors: Narciso, Hugh Louis Jr.
• Granted Patent: US 7,623,924 B2
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007

Abstract

Methods and devices are described for electrically stimulating nerves and organs to induce and modulate the production of hormones according to desired hormone production patterns and hormone level patterns to treat gynecological conditions. Such methods and devices may be used to treat or alleviate the symptoms of menopause. In addition, such methods and devices may be used for birth control.

Claims

1. A tissue stimulation device for treatment of gynecological conditions in a patient, comprising:

an electrical tissue stimulation energy source including a logic and control unit coupled to a memory unit that stores machine readable information read by the logic and control unit to produce a tissue stimulation pattern that induces a desired hormone level pattern for gynecologic hormones; and

an electrode in electrical communication with the electrical tissue stimulation energy source and configured to be coupled to a nerve of the patient.

2. The device of claim 1 further comprising a battery in electrical communication with the logic and control unit.

3. The device of claim 1 wherein the logic and control unit further comprises a data input channel for input of hormone concentration measurement data and a feedback loop configured to adjust an electrical dose of the tissue stimulation pattern according to the hormone concentration measurement data.

4. The device of claim 3 wherein the data input channel comprises an antenna.

5. The device of claim 1 wherein the tissue stimulation energy source comprises an IPG.

6. The device of claim 1 wherein the hormone level pattern induced by the tissue stimulation pattern corresponds to a hormone level pattern of a typical estrus cycle.

7. The device of claim 6 wherein the typical estrus cycle and tissue stimulation pattern are about 26 days to about 30 days in duration.

8. The device of claim 6 wherein the tissue stimulation pattern induces a hormone production pattern corresponding to a normal hormone production pattern for a typical estrus cycle.

9. The device of claim 8 wherein at least one of the hormones comprising the hormone production pattern is selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

10. The device of claim 6 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 14;

(b) holding the electrical dose constant from about day 15 to about day 18; and

(c) decreasing the electrical dose from about day 19 to about day 28.

11. The device of claim 10 wherein the tissue stimulation pattern further comprises repeating (a) through (c) at least once.

12. The device of claim 6 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding me electrical dose constant from about day 6 to about day 24; and

(c) decreasing the electrical dose from about day 25 to about day 28.

13. The device of claim 12 wherein the tissue stimulation pattern further comprises repeating (a) through (c) at least once.

14. The device of claim 6 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose substantially constant from about day 8 to about day 28; and

(c) continuing to hold the electrical dose substantially constant beyond day 28.

15. The device of claim 14 wherein the tissue stimulation pattern further comprises continuing to hold the electrical dose substantially constant until treatment is terminated.

16. A method of treating gynecological conditions in a body of a mammal, comprising:

stimulating tissue at a first stimulation energy dose to induce the production of at least one gynecologic hormone;

measuring the concentration of the at least one gynecologic hormone in the body of the mammal;

comparing the measured concentration of the at least one gynecologic hormone against a desired reference concentration; and

adjusting the stimulation energy dose according to any measured difference in concentration between the reference concentration and the measured concentration of the at least one gynecologic hormone; and

stimulating tissue at the adjusted stimulation energy dose.

17. The method of claim 16 wherein stimulating tissue is performed by a tissue stimulation device comprising a memory unit with machine readable information representing a desired hormone level pattern and wherein comparing the measured concentration of the at least one gynecologic hormone against a desired reference concentration comprises comparing the measured concentration against the desired hormone level pattern.

18. The method of claim 17 wherein the desired hormone level pattern comprises a pre-menstrual hormone level pattern for a human female.

19. A method of treating gynecological conditions in a mammal, comprising electrical stimulation of hormone producing organs to induce a predetermined gynecologic hormone level pattern.

20. The method of claim 19 wherein the gynecological condition being treated comprises menopause and wherein the predetermined gynecologic hormone level pattern comprises substantially the gynecologic hormone level pattern of a pre-menopausal mammal.

21. The method of claim 19, further comprising:

surgically implanting a programmable electrical tissue stimulation energy source that provides electrical stimulation with stimulation parameters that are controllable and repeatable; and

electrically stimulating tissues according to predetermined tissue stimulation patterns that induce the production of gynecologic hormones according to a predetermined pattern of hormone production.

22. The method of claim 19 where the mammal comprises a human.

23. The method of claim 19 where the electrical stimulation follows a tissue stimulation pattern configured to induce the production of a pattern of hormone levels corresponding to a typical estrus cycle pattern of hormone levels.

24. The method of claim 23 wherein the typical estrus cycle and pattern of hormone levels is about 26 to about 30 days in duration.

25. The method of claim 23 where the tissue stimulation pattern corresponds to an endogenous pattern of hormone levels and hormone production for a normal 28-day estrus cycle.

26. The method of claim 19 wherein the inducement of the predetermined gynecologic hormone level pattern comprises the inducement of the production of at least one hormone selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

27. The method of claim 25 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 14;

(b) holding the electrical dose substantially constant from about day 15 to about day 18; and

(c) decreasing the electrical dose from about day 19 to about day 28.

28. The method of claim 27 further comprising repeating (a) through (c) at least once.

29. The method of claim 25 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose substantially constant from about day 8 to about day 24; and

(c) decreasing the electrical dose from about day 25 to about day 28.

30. The method of claim 29 further comprising repeating (a) through (c) at least once.

31. The method of claim 25 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose substantially constant from about day 8 to about day 28; and

(c) continuing to hold the electrical dose substantially constant beyond day 28.

32. The method of claim 31 further comprising continuing to hold the electrical dose substantially constant until treatment is terminated.

33. A method of treating menopause including the periods known as pre-menopause, peri-menopause and post-menopause to prevent or reduce the severity of medical conditions and side effects associated with all phases of menopause, comprising:

(a) surgically implanting a tissue stimulation device that provides electrical stimulation with stimulation parameters that are controllable and repeatable; and

(b) electrically stimulating tissue with tissue stimulation energy from the tissue stimulation device according to a tissue stimulation pattern that induces a desired hormone level pattern.

34. The method of claim 33 wherein the frequency of the tissue stimulation energy is from about 1 Hz and about 50 Hz.

35. The method of claim 33 wherein the mammal comprises a human.

36. The method of claim 33 wherein the hormone level pattern induced by the tissue stimulation pattern corresponds to a hormone level pattern of a typical estrus cycle.

37. The method of claim 36 wherein the typical estrus cycle and tissue stimulation pattern are about 26 days to about 30 days in duration.

38. The method of claim 36 where the tissue stimulation pattern induces a hormone production pattern corresponding to a normal hormone production pattern for a typical estrus cycle.

39. The method of claim 38 wherein at least one of the hormones comprising the hormone production pattern is selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

40. The method of claim 38 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 14;

(b) holding the electrical dose constant from about day 15 to about day 18; and

(c) decreasing the electrical dose from about day 19 to about day 28.

41. The method of claim 40 further comprising repeating (a) through (c) at least once.

42. The method of claim 38 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose constant from about day 8 to about day 24; and

(c) decreasing the electrical dose from about day 25 to about day 28.

43. The method of claim 42 further comprising repeating (a) through (c) at least once.

44. The method of claim 38 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose substantially constant from about day 8 to about day 28; and

(c) continuing to hold the electrical dose substantially constant beyond day 28.

45. The method of claim 44 further comprising continuing to hold the electrical dose substantially constant until treatment is terminated.

46. A method of interrupting the normal estrus cycle in a mammal and altering the hormone production related to the estrus cycle to prevent pregnancy, comprising, electrical stimulation of tissue of the body of the mammal.

47. The method of claim 46 further comprising:

(a) surgically implanting a tissue stimulation device that provides electrical stimulation with stimulation parameters that are controllable and repeatable; and

(b) electrically stimulating tissue with tissue stimulation energy from the tissue stimulation device according to a tissue stimulation pattern that induces a desired hormone level pattern.

48. The method of claim 46 wherein the hormone level pattern induced by the tissue stimulation pattern corresponds to a hormone level pattern of a typical estrus cycle.

49. The method of claim 48 wherein the typical estrus cycle and tissue stimulation pattern are about 26 days to about 30 days in duration.

50. The method of claim 48 where the tissue stimulation pattern induces a hormone production pattern corresponding to a normal hormone production pattern for a typical estrus cycle.

51. The method of claim 50 wherein at least one of the hormones comprising the hormone production pattern is selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

52. The method of claim 50 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 14;

(b) holding the electrical dose constant from about day 15 to about day 18; and

(c) decreasing the electrical dose from about day 19 to about day 28.

53. The method of claim 52 further comprising repeating (a) through (c) at least once.

54. The method of claim 50 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose constant from about day 8 to about day 24; and

(c) decreasing the electrical dose from about day 25 to about day 28.

55. The method of claim 54 further comprising repeating (a) through (c) at least once.

56. The method of claim 50 wherein the tissue stimulation pattern comprises:

(a) increasing the electrical dose from about day 1 to about day 7;

(b) holding the electrical dose substantially constant from about day 8 to about day 28; and

(c) continuing to hold the electrical dose substantially constant beyond day 28.

57. The method of claim 56 further comprising continuing to hold the electrical dose substantially constant until treatment is terminated.

58. The method of claim 46 wherein estrus is interrupted without raising the baseline mean arterial pressure of the mammal by more than 25%.

59. The method of claim 46 wherein estrus is interrupted without raising the baseline heart rate of the mammal by more than 25%.

60. A method of treating multiple gynecology conditions in a mammal, comprising, electrically stimulating tissues with multiple tissue stimulation patterns so as to alter the hormone production.

61. The method of claim 60 wherein the gynecological conditions comprise interruption of the estrus cycle and treatment of menopause and wherein the gynecological conditions are treated separately and sequentially.

62. The method of claim 60 wherein the gynecological conditions comprise interruption of the estrus cycle to prevent pregnancy, resumption of normal estrus through interruption of electrical tissue stimulation to allow a resumption of a normal estrus cycle and conception, interruption of the estrus cycle a second time to prevent pregnancy and treatment of menopause by changing the tissue stimulation pattern.