Devices and methods for gynecologic hormone modulation in mammals

• US 7,623,924 B2
• Filed: 08/30/2005
• Issued: 11/24/2009
• Est. Priority Date: 08/31/2004
• Status: Expired due to Fees

• Current Assignee: Leptos Biomedical, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Leptos Biomedical, Inc. (Abbott Laboratories Incorporated)
• Inventors: Narciso, Hugh Louis Jr.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/215,892
• Publication Number:
  US 20060079943A1
• Time in Patent Office: 1,547 Days
• Field of Search: 607/39, 607 1- 3, 607/45, 607/46
• 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 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 method of treating gynecological conditions in a body of a mammal, comprising:

stimulating tissue at a first stimulation energy dose to induce a production of at least one gynecologic hormone, the first stimulation energy dose having at least one frequency, at least one pulse width, at least one duty cycle and at least one intensity;

measuring a 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;

adjusting the first stimulation energy dose according to any measured difference in concentration between the desired reference concentration and the measured concentration; and

stimulating tissue at an adjusted stimulation energy dose having at least one frequency, at least one pulse width, at least one duty cycle and at least one intensity,

wherein the stimulating 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 against the desired reference concentration comprises comparing the measured concentration against the desired hormone level pattern; and

wherein the desired hormone level pattern comprises a pre-menopausal hormone level pattern for a human female.

2. The method of claim 1, further comprising:

surgically implanting the tissue stimulation device.

3. The method of claim 1 wherein the desired hormone level pattern comprises a pattern of hormone levels corresponding to a typical estrus cycle pattern of hormone levels.

4. The method of claim 3 wherein the desired hormone level pattern is about 26 to about 30 days in duration.

5. The method of claim 1 wherein the at least one gynecologic hormone is selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

6. The method of claim 1 wherein the at least one frequency of the adjusted stimulation energy dose is from about 1 Hz to about 50 Hz.

7. The method of claim 1 wherein stimulation occurs without raising the baseline mean arterial pressure of the mammal by more than 25%.

8. The method according to claim 1, wherein the pulse width of the first energy stimulation dose comprises from about 125 microseconds to about 1000 microseconds.

9. The method according to claim 1, wherein the intensity of the first energy stimulation dose comprises up to about 10 mAmps.

10. The method according to claim 1, wherein the duty cycle of the first energy stimulation dose comprises from about 5 to about 60%.

11. The method according to claim 1, wherein the pulse width of the adjusted energy stimulation dose comprises from about 125 microseconds to about 1000 microseconds.

12. The method according to claim 1, wherein the intensity of the adjusted energy stimulation dose comprises up to about 10 mAmps.

13. The method according to claim 1, wherein the duty cycle of the adjusted energy stimulation dose comprises from about 5 to about 60%.

14. The method according to claim 1, wherein the stimulated tissue comprises a vagus nerve, an autonomic sympathetic nerve, a splanchnic nerve, an ovarian nerve, an adrenal gland, an adrenal cortex, an adrenal medulla, an ovary, a uterus, a pen-abdominal fat, a hypothalamus or a pituitary.

15. A method of treating multiple gynecology conditions in a mammal, comprising, electrically stimulating tissues with multiple tissue stimulation patterns having at least one frequency, at least one pulse width, at least one intensity and at least one duty cycle, so as to alter hormone production of the mammal, 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.

16. The method of claim 15 wherein stimulation occurs without raising the baseline heart rate of the mammal by more than 25%.

17. The method of claim 15, further comprising surgically implanting a programmable electrical tissue stimulation energy source that provides electrical stimulation with stimulation parameters that are controllable and repeatable.

18. The method of claim 15, wherein the electrical stimulation for the treatment of menopause follows a tissue stimulation pattern configured to induce production of a pattern of hormone levels corresponding to a typical estrus cycle pattern of hormone levels.

19. The method of claim 18, wherein the typical estrus cycle and pattern of hormone levels is about 26 to about 30 days in duration.

20. The method of claim 15, wherein the multiple tissue stimulation patterns alter the hormone production of at least one hormone selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

21. The method of claim 15, wherein the at least one frequency of the multiple tissue stimulation patterns is from about 1 Hz to about 50 Hz.

22. The method according to claim 15, wherein the at least one pulse width of the multiple stimulation patterns comprises from about 125 microseconds to about 1000 microseconds.

23. The method according to claim 15, wherein the at least one intensity of the multiple stimulation patterns comprises up to about 10 mAmps.

24. The method according to claim 15, wherein the at least one duty cycle comprises from about 5 to about 60%.

25. The method according to claim 15, wherein the stimulated tissues comprise a vagus nerve, an autonomic sympathetic nerve, a splanchnic nerve, an ovarian nerve, an adrenal gland, an adrenal cortex, an adrenal medulla, an ovary, a uterus, a pen-abdominal fat, a hypothalamus or a pituitary.

26. A method of treating multiple gynecology conditions in a mammal, comprising, electrically stimulating tissues with multiple tissue stimulation patterns having at least one frequency, at least one pulse width, at least one intensity and at least one duty cycle, so as to alter hormone production of the mammal, wherein the gynecological conditions comprise interruption of the estrus cycle and treatment of menopause and wherein the gynecological conditions are treated separately and sequentially.

27. The method of claim 26 wherein the tissue stimulation pattern for the treatment of menopause 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 26 wherein the tissue stimulation pattern for the treatment of menopause 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 26 wherein the tissue stimulation pattern for the treatment of menopause 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. The method of claim 26, further comprising surgically implanting a programmable electrical tissue stimulation energy source that provides electrical stimulation with stimulation parameters that are controllable and repeatable.

34. The method of claim 26, wherein the multiple tissue stimulation patterns alter the production of at least one hormone selected from the group consisting of estrogen, progesterone, estradiol, pregnenolone, androstenedione, estrone, androgens, and progestins.

35. The method of claim 26, wherein the at least one frequency of the multiple tissue stimulation patterns is from about 1 Hz to about 50 Hz.

36. The method of claim 26, wherein stimulation occurs without raising the baseline mean arterial pressure of the mammal by more than 25%.

37. The method according to claim 26, wherein the at least one pulse width of the multiple stimulation patterns comprises from about 125 microseconds to about 1000 microseconds.

38. The method according to claim 26, wherein the at least one intensity of the multiple stimulation patterns comprises up to about 10 mAmps.

39. The method according to claim 26, wherein the at least one duty cycle comprises from about 5 to about 60%.

40. The method according to claim 26, wherein the stimulated tissues comprise a vagus nerve, an autonomic sympathetic nerve, a splanchnic nerve, an ovarian nerve, an adrenal gland, an adrenal cortex, an adrenal medulla, an ovary, a uterus, a pen-abdominal fat, a hypothalamus or a pituitary.