Methods and systems for electrical and/or drug stimulation as a therapy for erectile dysfunction

• US 20050209652A1
• Filed: 04/22/2005
• Published: 09/22/2005
• Est. Priority Date: 04/26/2001
• 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.
• Granted Patent: US 7,660,631 B2
• Time in Patent Office: Days
• 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
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

Systems and methods for introducing one or more stimulating drugs and/or applying electrical stimulation to tissue affecting the penis to treat erectile dysfunction (for instance, following prostate surgery) uses at least one implantable system control unit (SCU) producing electrical pulses delivered via electrodes and/or producing drug infusion pulses, wherein the stimulating drug(s) are delivered via one or more pumps and infusion outlets.

Claims

1. A method comprising:

stimulating tissue affecting the penis of a prostate surgery patient;

wherein the prostate surgery patient suffers from erectile dysfunction, and

wherein stimulating tissue affecting the penis of the prostate surgery patient includes stimulation via at least one of electrical stimulation and drug infusion; and

determining if the patient is responsive to stimulation to promote erection.

2. The method of claim 1 further comprising:

providing at least one of a lead and a catheter, wherein the lead includes at least one stimulating electrode at a distal portion of the lead and the catheter includes at least one infusion outlet at a distal portion of the catheter;

operably connecting at least one system control unit to a proximal portion of at least one of the lead and the catheter for the patient;

providing operating power to the at least one system control unit;

providing stimulation parameters to the at least one system control unit;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses via at least one of the lead and the catheter to the tissue affecting the penis.

3. The method of claim 2 wherein the stimulation pulses are infusion pulses providing at least one of an excitatory drug, acetylcholine and an acetylcholine agonist.

4. The method of claim 2 wherein the stimulation pulses are electrical pulses.

5. The method of claim 2 wherein the tissue affecting the penis comprises one or more of 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.

6. The method of claim 5 wherein the stimulation pulses are infusion pulses providing at least one of an inhibitory drug, GABA, phentolamine, and a norepinephrine antagonist.

7. The method of claim 5 wherein the stimulation pulses are electrical pulses

8. The method of claim 2 wherein the tissue affecting the penis comprises at least one of the corpus cavernosa, corpus spongiosum, cavernous nerves, nerves of the prostatic plexus, branches of the prostatic plexus, pelvic splanchnic nerves, second, third, and fourth sacral nerves, sympathetic ganglia from which the hypogastric nerves arise, hypogastric nerves, nerves of the inferior hypogastric plexus, branches of the inferior hypogastric plexus, branches of the inferior hypogastric plexus that innervate at least one of the prostate, seminal vesicles, and vas deferens, pelvic splanchnic nerves leading to the prostate, blood vessels supplying the penis, blood vessels draining the penis, internal iliac arteries, internal pudendal arteries, dorsal arteries of the penis, deep arteries of the penis, the deep dorsal vein of the penis, and the urethra.

9. The method of claim 8 wherein the stimulation pulses are infusion pulses providing at least one of a drug that elevates cyclic nucleotides in penile cavernosal smooth muscle, a drug that inhibits PDE5, a drug that inhibits degradation of cGMP, vasoactive intestinal polypeptide, prostaglandin E₁, sildenafil, vardenafil, cGMP, acetylcholine, nitric oxide, analogs of nitric oxide, a guanylyl cyclase nitric oxide receptor agonist, papaverine, phentolamine, an androgen, a gene that leads to improved erectile response, and a gene product that leads to improved erectile response.

10. The method of claim 1 wherein the tissue affecting the penis supplies parasympathetic input that promotes erection and wherein the tissue affecting the penis comprises at least one nerve of the cavernous nerves, the prostatic plexus, branches of the prostatic plexus, the pelvic splanchnic nerves, and the second, third, and fourth sacral nerves.

11. The method of claim 2 wherein the tissue affecting the penis affects emission or ejaculation.

12. The method of claim 11 wherein the tissue affecting the penis 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.

13. The method of claim 11 wherein the at least one nerve comprises at least one of the pelvic splanchnic nerves leading to the prostate.

14. The method of claim 1 further comprising sensing a condition of the patient with at least one sensor and using the sensed condition to adjust the stimulation parameters of at least one system control unit.

15. A method for treating a prostatic surgery patient comprising:

providing a system control unit for delivering stimulation to tissue;

implanting the system control unit adjacent to tissue affecting the penis;

applying stimulation via the system control unit to determine if a patient with erectile dysfunction is responsive to stimulation to promote erection;

providing operating power to the system control unit;

providing stimulation parameters to the system control unit;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to the tissue affecting the penis.

16. The method of claim 15 wherein the system control unit is leadless.

17. The method of claim 15 wherein the system control unit includes at least one of a lead and a catheter.

18. A system comprising:

at least one of a lead and a catheter, the lead including at least one stimulating electrode and the catheter including at least one infusion outlet;

a system control unit configured for connection to at least one of the lead and the catheter, and configured to apply stimulation through at least one of the lead and the catheter; and

wherein at least one of the electrode and the infusion outlet deliver stimulation pulses to tissue affecting the penis in a prostate surgery patient with erectile dysfunction; and

wherein the patient is responsive to stimulation to promote erection.

19. The system of claim 18, further comprising:

means for providing operating power to the system control unit;

means for providing stimulation parameters to the system control unit; and

means for generating stimulation pulses in accordance with the stimulation parameters.

20. The system of claim 18, further comprising an external stimulator configured for connection to at least one of the lead and the catheter, and configured to apply stimulation through at least one of the lead and the catheter to tissue affecting the penis.