Device and therapy for erectile dysfunction and other sexual dysfunction

• US 7,865,243 B1
• Filed: 01/24/2006
• Issued: 01/04/2011
• Est. Priority Date: 04/07/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K, McGivern, James P
• Primary Examiner(s): ROBINSON, DANIEL LEON
• Application Number:
  US11/338,006
• Time in Patent Office: 1,806 Days
• Field of Search: 607/39, 607/143, 607/2, 128/788
• US Class Current: 607/39
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

An implantable stimulator(s) with at least one infusion outlet and/or at least one electrode, is implanted with the outlet(s) and/or electrode(s) located adjacent to a pudendal nerve(s) and potentially other nerve(s) innervating the reproductive organs, such as the cavernous nerve(s). Stimulation of such nerve(s) is provided via stimulating drugs and/or electrical stimulation as a therapy for erectile dysfunction. The stimulator uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a battery is accomplished, for example, by inductive coupling with an external appliance. The stimulator provides means of stimulating a nerve(s) when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power. The system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes a sensor, and the sensed condition is used to adjust stimulation parameters.

Claims

1. A method for treating a patient with sexual dysfunction comprising:

providing at least one stimulator having at least one electrode;

implanting the at least one stimulator adjacent to at least one nerve supplying somatic motor input to the penis;

providing operating power to the at least one stimulator;

using at least one external appliance to transmit stimulation parameters to the at least one stimulator;

receiving and storing the stimulation parameters;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerve fibers adjacent to the at least one stimulator.

2. The method of claim 1 wherein the stimulation pulses are excitatory stimulation pulses.

3. The method of claim 2 wherein the at least one nerve supplying somatic motor input to the penis comprises at least one of the pudendal nerves.

4. The method of claim 3 wherein the at least one pudendal nerve is at least one of the pudendal nerve and the dorsal nerve of the penis.

5. The method of claim 1 further comprising implanting at least one electrode adjacent to at least one nerve providing autonomic innervation of the penis.

6. The method of claim 5 wherein the at least one nerve providing autonomic innervation of the penis comprises one or more of the cavernous nerves, the nerves of the prostatic plexus, the nerves of the branches of the prostatic plexus, the nerves of the uterovaginal plexus, the nerves of the branches of the uterovaginal plexus, the pelvic splanchnic nerves, the second, third, and fourth sacral nerves, the hypogastric nerves, the sympathetic ganglia from which the hypogastric nerves arise, the hypogastric nerves, the nerves of the inferior hypogastric plexus, and the nerves of the branches of the inferior hypogastric plexus.

7. The method of claim 1 wherein the implantable stimulator further comprises at least one sensor.

8. The method of claim 7 wherein the sensed condition is used to adjust the stimulation parameters.

9. The method of claim 1 wherein the at least one electrode is positioned on a lead.

10. A method for treating a patient with at least one sexual dysfunction, comprising the steps of:

providing at least one means for stimulating tissue;

implanting the at least one stimulating means adjacent to at least one nerve innervating at least one reproductive organ;

providing operating power to the at least one stimulating means;

transmitting stimulation parameters to the at least one stimulating means using at least one external appliance;

receiving and storing the stimulation parameters;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerves fibers adjacent to the at least one stimulating means;

wherein the stimulating means includes at least one lead.

11. The method of claim 10 wherein the stimulating means is no more than about 150 mm from the at least one nerve to be stimulated.

12. The method of claim 11 wherein the at least one nerve comprises one or more of the cavernous nerves, the nerves of the prostatic plexus, the nerves of the branches of the prostatic plexus, the nerves of the uterovaginal plexus, the nerves of the branches of the uterovaginal plexus, the pelvic splanchnic nerves, the second, third, and fourth sacral nerves, the hypogastric nerves, the sympathetic ganglia from which the hypogastric nerves arise, the hypogastric nerves, the nerves of the inferior hypogastric plexus, and the nerves of the branches of the inferior hypogastric plexus.

13. The method of claim 10 wherein the stimulation pulses are excitatory stimulation pulses.

14. The method of claim 13 wherein the at least one nerve innervating at least one reproductive organ comprises at least one nerve supplying somatic motor input to the penis.

15. The method of claim 14 wherein the at least one nerve supplying somatic motor input to the penis comprises at least one of the pudendal nerves.

16. A method for treating a patient with sexual dysfunction comprising:

providing at least one stimulator having at least two electrodes;

implanting the at least one stimulator adjacent to at least one nerve innervating the reproductive organs;

providing operating power to the at least one stimulator;

using at least one external appliance to transmit stimulation parameters to the at least one stimulator;

receiving and storing the stimulation parameters;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerve fibers adjacent to the at least one stimulator;

wherein the stimulator has a size and shape suitable for placement of the electrodes adjacent to the at least one nerve innervating the reproductive organs.

17. The method of claim 16 wherein the at least one nerve comprises at least one nerve of the cavernous nerves, the prostatic plexus, branches of the prostatic plexus, the uterovaginal plexus, branches of the uterovaginal plexus, the pelvic splanchnic nerves, the second, third, and fourth sacral nerves, and the hypogastric nerves.

18. The method of claim 16 wherein the at least one nerve comprises one or more of the sympathetic ganglia from which the hypogastric nerves arise, the nerves of the inferior hypogastric plexus, and the nerves of the branches of the inferior hypogastric plexus.

19. The method of claim 18 wherein the at least one nerve comprises at least one nerve of the branches of the inferior hypogastric plexus that innervate at least one of the prostate, seminal vesicles, and vas deferens.

20. The method of claim 16 wherein the at least one nerve effects emission or ejaculation.