Treatment of reproductive endocrine disorders by vagus nerve stimulation

• US 7,657,310 B2
• Filed: 01/26/2006
• Issued: 02/02/2010
• Est. Priority Date: 01/26/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Buras, William R.
• Primary Examiner(s): Manuel; George
• Application Number:
  US11/340,309
• Publication Number:
  US 20070173891A1
• Time in Patent Office: 1,468 Days
• Field of Search: 607/2, 607/3, 607/45, 607/116, 607/118, 607/39, 607/46
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

I disclose a method of treating a reproductive endocrine disorder in a patient, including coupling at least one electrode to at least one portion of a cranial nerve of the patient; and applying an electrical signal to said cranial nerve using said electrode to treat said reproductive endocrine disorder. Among the reproductive endocrine disorders which may be treated by the method are gonadal dysgenesis, hypogonadism, hypergonadism, delayed puberty, amenorrhea, infertility, premature menopause, and polycystic ovarian disease.

Claims

1. A method of treating a reproductive disorder in a patient, comprising:

coupling at least one electrode to at least one portion of a cranial nerve of the patient, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, an accessory nerve, or a hypoglossal nerve; and

applying an electrical signal to said cranial nerve using said electrode to treat said reproductive disorder, wherein treating said reproductive disorder comprises treating a disorder selected from the group consisting of infertility and amenorrhea.

2. The method of claim 1, wherein the cranial nerve is a vagus nerve.

3. The method of claim 1, wherein treating said reproductive disorder comprises treating a disorder selected from the group consisting of gonadal dysgenesis, hypogonadism, hypergonadism, delayed puberty, amenorrhea, infertility, premature menopause, polycystic ovarian syndrome, osteoporosis, hirsutism, and sarcopenia.

4. The method of claim 1, wherein applying said electrical signal comprises applying said electrical signal in synchronization with a normal endogenous endocrine cycle.

5. The method of claim 1, further comprising detecting a symptom of the reproductive disorder, and wherein applying the electrical signal is initiated in response to detecting said symptom.

6. The method of claim 1, wherein applying the electrical signal comprises applying said signal to the cranial nerve using said at least one electrode during a first treatment period, and said method further comprises applying a second electrical signal to the cranial nerve using said at least one electrode during a second treatment period, to treat the reproductive disorder.

7. The method of claim 1, wherein applying the electrical signal comprises blocking one of afferent and efferent action potentials on the cranial nerve.

8. The method of claim 1, further comprising the steps of:

providing a programmable electrical signal generator;

coupling said signal generator to said at least one electrode;

generating an electrical signal with the electrical signal generator; and

applying the electrical signal to the electrode.

9. The method of claim 8, further comprising programming the electrical signal generator to define the electrical signal by at least one parameter selected from the group consisting of a current magnitude, a pulse frequency, a pulse width, an on-time and an off-time, wherein said at least one parameter is selected to treat the reproductive disorder.

10. The method of claim 9, further comprising detecting one or more of the period or the amplitude of an endocrine cycle associated with the reproductive endocrine disorder, and wherein the parameter of the electrical signal is modified in response to detecting said period or said amplitude.

11. The method of claim 1, wherein applying an electrical signal to said cranial nerve comprises applying an electrical signal from a medical device selected from the group consisting of an implantable medical device, an external medical device, and a partially implantable medical device.

12. A method of treating a reproductive endocrine disorder in a patient, comprising:

coupling at least one electrode to at least a portion of a cranial nerve of the patient, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, an accessory nerve, or a hypoglossal nerve;

receiving a signal indicative of a symptom of the reproductive endocrine disorder; and

applying an electrical signal to said cranial nerve using said electrode to treat said reproductive endocrine disorder in response to receiving said signal indicative of said symptom, wherein applying said electrical signal comprises applying said electrical signal in synchronization with at least one endogenous endocrine cycle.

13. The method of claim 12, wherein applying the electrical signal comprises applying said signal to the cranial nerve using said at least one electrode during a first treatment period, and said method further comprises applying a second electrical signal to the cranial nerve using said at least one electrode during a second treatment period, to treat the reproductive endocrine disorder.

14. The method of claim 12, wherein treating said reproductive endocrine disorder comprises treating a disorder selected from the group consisting of gonadal dysgenesis, hypogonadism, hypergonadism, delayed puberty, amenorrhea, infertility, premature menopause, and polycystic ovarian disease.

15. The method of claim 12, further comprising:

providing a drug delivery device in fluid communication with the bloodstream of the patient; and

releasing from said drug delivery device a drug capable of treating said reproductive endocrine disorder in response to receiving said signal indicative of said symptom.

16. The method of claim 15, wherein releasing a drug comprises releasing a drug selected from the group consisting of follicle stimulating hormone (FSH), luteinizing hormone (LH), human chorionic gonadotropin (hCG), a luteinizing hormone-releasing hormone (LHRH) agonist, an estrogen, an anti-androgen, selective estrogen reuptake modulators, a hormone replacement therapy drug, oxytocin, and a steroid.

17. The method of claim 15, wherein treating said reproductive endocrine disorder comprises treating a disorder selected from the group consisting of gonadal dysgenesis, hypogonadism, hypergonadism, delayed puberty, amenorrhea, infertility, premature menopause, and polycystic ovarian disease.

18. The method of claim 15, further comprising:

applying a first signal to said drug delivery device to release said drug during a first time period;

receiving a second indication of a symptom of the reproductive endocrine disorder subsequent to delivery of said drug;

applying said electrical signal to said portion of said cranial nerve during a second time period in response to said receiving said second indication of a symptom of the

reproductive endocrine disorder.

19. An implantable medical device system, comprising:

an electrode adapted to be coupled to a cranial nerve of a patient, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, an accessory nerve, or a hypoglossal nerve, and

an implantable medical device for treating at least one reproductive disorder in a patient, comprising a controller for providing an electrical signal to the electrode, to treat said reproductive disorder, wherein treating said reproductive disorder comprises treating a disorder selected from the group consisting of and amenorrhea.

20. The implantable medical device of claim 19, further comprising:

a sensor for sensing a symptom of the reproductive disorder; and

wherein said controller receives a sensor signal from said sensor indicative of said symptom, and provides said electrical signal to said electrode in response to receiving said sensor signal.

21. An implantable medical device system, comprising:

an electrode adapted to be coupled to a cranial nerve of a patient, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, an accessory nerve, or a hypoglossal nerve, and

an implantable medical device for treating at least one reproductive disorder in a patient, comprising a controller for providing an electrical signal to the electrode for treating said reproductive endocrine disorder, wherein treating said reproductive disorder comprises treating a disorder selected from the group consisting of gonadal dysgenesis, hypogonadism, hypergonadism, delayed puberty, amenorrhea, infertility, premature menopause, polycystic ovarian syndrome, osteoporosis, hirsutism, and sarcopenia.

22. A method of treating a reproductive disorder in a patient, comprising:

coupling at least one electrode to at least one portion of a cranial nerve of the patient, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, an accessory nerve, or a hypoglossal nerve; and

applying an electrical signal to said cranial nerve using said electrode to treat said reproductive disorder, wherein said electrical signal is applied in synchronization with said at least one endogenous endocrine cycle.