Treatment of female fertility conditions through modulation of the autonomic nervous system

• US 7,676,269 B2
• Filed: 12/29/2003
• Issued: 03/09/2010
• Est. Priority Date: 12/29/2003
• Status: Active Grant

• Current Assignee: Palo Alto Investors
• Original Assignee: Palo Alto Investors
• Inventors: Lee, Patrick Yuarn-Bor, Yun, Anthony Joonkyoo
• Primary Examiner(s): Evanisko; George R
• Assistant Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/748,976
• Publication Number:
  US 20050143788A1
• Time in Patent Office: 2,262 Days
• Field of Search: 607/39, 607/2
• US Class Current: 607/39
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Abstract

Methods are provided for treating a subject for a fertility condition. In accordance with the subject methods, at least a portion of a subject'"'"'s autonomic nervous system is modulated to increase the sympathetic activity/parasympathetic activity ratio in a manner that is effective to treat the subject for the condition. Embodiments of the subject invention include modulating a subject'"'"'s autonomic nervous system using electrical energy and/or one or more pharmacological agents. The subject methods find use in the treatment of a variety of different fertility conditions. Also provided are kits for use in practicing the subject methods.

Claims

1. A method of treating a female subject for a fertility condition, said method comprising:

providing a female subject known to suffer from said fertility condition; and

modulating at least a portion of the autonomic nervous system of said female subject to increase the sympathetic activity/parasympathetic activity ratio of said subject in a manner effective to treat said female subject for said fertility condition, wherein said method further comprises determining said sympathetic activity/parasympathetic activity ratio at least prior to said modulation and performing said modulation of said at least one portion of the autonomic nervous system based on the determined sympathetic activity/parasympathetic activity ratio.

2. The method of claim 1, wherein said modulation is performed during at least one predetermined phase of said subject'"'"'s menstrual cycle.

3. The method of claim 2, wherein said predetermined phase is the luteal phase.

4. The method of claim 1, wherein said increase of the sympathetic activity/parasympathetic activity ratio comprises increasing sympathetic activity.

5. The method of claim 1, wherein said increase of the sympathetic activity/parasympathetic activity ratio comprises decreasing parasympathetic activity.

6. The method of claim 1, wherein said increase of the sympathetic activity/parasympathetic activity ratio comprises increasing sympathetic activity and decreasing parasympathetic activity.

7. The method of claim 1, wherein said modulation is localized.

8. The method of claim 7, wherein said modulation is localized to at least one pelvic nerve.

9. The method of claim 1, wherein said modulation is accomplished by at least applying electrical energy to said at least one portion of said autonomic nervous system.

10. The method of claim 9, wherein said application of electrical energy comprises electrically increasing activity in at least one portion of said autonomic nervous system.

11. The method of claim 9, wherein said application of electrical energy comprises electrically inhibiting activity in at least one portion of said autonomic nervous system.

12. The method of claim 1, wherein said modulation is accomplished by at least administering an effective amount of at least one pharmacological agent to said subject.

13. The method of claim 12, wherein said at least one pharmacological agent is chosen from:

beta agonists, alpha agonists, prednisone, steroids, indirect agents that include norepinephrine, epinephrine, norepinephrine, acetyicholine, sodium, calcium, angiotensin I, angiotensin II, angiotensin converting enzyme I, angiotensin converting enzyme II, aldosterone, potassium channel blockers, magnesium channel blockers, cocaine, amphetamines, ephedrine, terbutaline, dopamine, doputamine, antidiuretic hormone, oxytocin, THC cannabinoids, and combinations thereof.

14. The method of claim 12, wherein said method comprises combining said at least one pharmacological agent with seminal fluid to provide an at least one pharmacological agent containing seminal fluid mixture and administering said mixture to said subject.

15. The method of claim 1, wherein said method further comprises determining said sympathetic activity/parasympathetic activity ratio at least during said modulation.

16. The method of claim 1, wherein said method further comprises determining said sympathetic activity/parasympathetic activity ratio at least following said modulation.

17. The method of claim 1, further comprising determining the ratio of Th-1 activity/Th-2 activity.

18. The method of claim 1, wherein said fertility condition is infertility.

19. The method of claim 1, wherein said infertility condition is subfertility.

20. The method of claim 1, wherein said fertility condition is early pregnancy loss.

21. The method of claim 1, wherein said fertility condition is spontaneous abortion.

22. The method of claim 1, wherein said fertility condition is an implantation failure.

23. The method of claim 1, wherein said fertility condition is amenorrhea.

24. The method of claim 1, wherein said fertility condition is luteal insufficiency.

25. The method of claim 1, wherein said fertility condition is dysmenorrhea.

26. The method of claim 1, wherein said fertility condition is chemical pregnancy loss.

27. The method of claim 1, wherein said fertility condition is stillbirth.

28. The method of claim 1, wherein said fertility condition is habitual abortion.

29. The method of claim 7, wherein said modulation is localized to an area of the autonomic nervous system selected from the group consisting of pre-ganglionic nerve fibers, post-ganglionic nerve fibers, ganglionic structures, efferent nerve fibers, and afferent nerve fibers.

30. The method of claim 1, wherein said sympathetic activity/parasympathetic activity ratio is determined by sensing conduction in at least a portion of the sympathetic and/or parasympathetic nervous system.

31. The method according to claim 1, wherein said modulation comprises an implanted electrical energy delivering device.

32. The method according to claim 31, wherein said implanted device is an electrode.

33. The method according to claim 5, wherein said decrease in parasympathetic activity comprises electrical inhibition of at least one portion of the parasympathetic nervous system.

34. The method according to claim 33, wherein said electrical inhibition comprises ablation.

35. The method according to claim 1, wherein said modulation is performed for a period of days.

36. The method according to claim 1, wherein said modulation is performed for a period of weeks.