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

• US 7,660,631 B2
• Filed: 04/22/2005
• Issued: 02/09/2010
• Est. Priority Date: 04/26/2001
• Status: Expired due to Fees

• 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): MANUEL, GEORGE C
• Application Number:
  US11/112,630
• Publication Number:
  US 20050209652A1
• Time in Patent Office: 1,754 Days
• Field of Search: 600/38, 600/41, 607/2, 607/39, 607/40, 607/72, 604/21, 514/252.03, 514/573, 514/645, 424/198.1, 128/898, 128/899, 3 3/8
• 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 for performing prostate surgery, comprising:

during a prostate surgery;

positioning an implantable device to stimulate a tissue affecting the penis of the prostate surgery patient;

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

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

2. The method of claim 1 wherein:

the implantable device comprises a system control unit and 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 and the system control unit is operably connected at least one system control unit to a proximal portion of the at least one of the lead and the catheter for the patient;

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

stimulating the tissue affecting the penis comprises;

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 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.

9. The method of claim 2 wherein stimulating the tissue affecting the penis comprises affecting emission or ejaculation.

10. The method of claim 9 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.

11. The method of claim 9 wherein the at least one nerve comprises at least one of the pelvic splanchnic nerves leading to the prostate.

12. The method of claim 2 further comprising:

sensing a condition of the patient with at least one sensor; and

using the sensed condition to adjust at least one of the stimulation parameters of the system control unit.

13. 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, so that the system control unit is generally within 150 mm of the 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.

14. The method of claim 13 wherein the system control unit is leadless.

15. The method of claim 13 wherein the system control unit includes at least one of a lead and a catheter.

16. A system comprising:

an implantable stimulator comprising an implantable package housing electrical circuitry configured to control localized application of at least one of electrical stimulation and chemical stimulation to a tissue affecting the penis;

a sensing device configured to sense a physiological condition indicative of an erection of the penis; and

a communication link between the electrical circuitry and the sensing device,

wherein the sensing device, the electrical circuitry, and the communication link are in a closed loop to control one or more parameters of the application of the at least one of the electrical stimulation and the chemical stimulation.

17. The system of claim 16, wherein at least part of the sensing device is housed in the implantable package.

18. The system of claim 16, wherein the sensing device comprises a pressure sensor.

19. The system of claim 16, wherein the communication link between the electrical circuitry and the sensing device is direct.