Method and system for providing pulsed electrical stimulation to provide therapy for erectile/sexual dysfunction, prostatitis, prostatitis pain, and chronic pelvic pain

• US 20050131484A1
• Filed: 06/07/2004
• Published: 06/16/2005
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Granted Patent: US 7,330,762 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

Abstract

A method and system for providing pulse electrical stimulation to at least one of sacral plexus or its branches or portions, inferior hypogastric plexus or its branches or portions, superior hypogastric plexus or its branches or portions in a patient, to provide therapy for one of erectile/sexual dysfunction, prostatitis, pelvic pain, and pain originating from prostatitis pathology. The stimulation system comprises both implanted and external components. The pulsed electrical stimulation may be provided using one of the following stimulation systems: a) an implanted stimulus-receiver with an external stimulator; b) an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator; c) a programmer-less implantable pulse generator (IPG) which is operable with an external magnet; d) a programmable implantable pulse generator; e) a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and f) an implantable pulse generator (IPG) comprising a rechargeable battery. The stimulation pulses can be provided uni-directionally. In one embodiment, the external components such as the programmer or external stimulator may comprise a telemetry means for networking. The telemetry means therefore, allows for interrogation or programming of implanted device from a remote location, over a wide area network.

Claims

1. A method of providing pulsed electrical stimulation to at least one of sacral plexus, inferior hypogastric plexus, and superior hypogastric plexus or their branches or portion thereof, for treating or alleviating the symptoms for at least one of erectile/sexual dysfunction, prostatitis, pelvic pain, pain originating from prostatitis pathology, comprising the steps of:

a) providing a microprocessor based pulse generator to supply electrical pulses;

wherein said pulse generator consists of one from a group comprising of;

an implanted stimulus-receiver with an external stimulator;

an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator;

a programmer-less implantable pulse generator (IPG) which is operable with a magnet;

a programmable implantable pulse generator;

a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and

an IPG comprising a rechargeable battery;

b) providing at least one predetermined program to control the output of said pulse generator;

c) providing a lead in electrical contact with said pulse generator;

d) activating said at least one predetermined program to emit said electrical pulses to at least one said plexuses or their branches or portion thereof; and

e) providing at least one electrode connected to said lead;

wherein said at least one electrode is adapted to be in contact with at least one of said plexuses or their branches or portion thereof,

to provide said pulsed electrical pulses for said disorders.

2. A method of claim 1, wherein said plexuses or their branches or portion thereof in a patient further comprises, at least one of the pudendal nerve or its branches or portion thereof, the cavernous nerve or its branches or portion thereof, the prostatic plexus nerve or its branches or portion thereof, the sacral splanchnic nerve or its branches or portion thereof, or pelvic splanchnic nerve or its branches or portion thereof, or sacral nerves S1, S2, S3, or S4.

3. A method of claim 1, wherein said pulse generator further comprises telemetry means to remotely interrogate said pulse generator.

4. A method of claim 1, wherein said pulse generator further comprises telemetry means to remotely control said electrical pulses.

5. A method of claim 1, wherein said electrical pulses are provided to said nerves for unidirectional stimulation.

6. A method of claim 1, wherein said electrical pulses are provided at any point along the length of said plexuses or their branches or portion thereof.

7. A method of claim 1, wherein said predetermined program(s) comprises:

a) at least one variable component selected from a group comprising of pulse amplitude, pulse width, pulse frequency, ON-time, and OFF-time; and

b) controls said variable component of said electric pulses.

8. A method of claim 1, wherein said predetermined program(s) can be modified.

9. A method for treating or alleviating the symptoms for at least one of erectile/sexual dysfunction, prostatitis, pelvic pain, and pain originating from prostatitis pathology, with neuromodulation therapy, comprising the steps of:

a) selecting a patient for said neuromodulation therapy;

b) providing a pulse generator system, wherein said pulse generator system comprises implantable and external components, and wherein said pulse generator system further comprises a microprocessor based circuitry;

c) providing programming means to program said pulses generated by said pulse generator;

d) providing telemetry means for remote 2-way communication with said pulse generator over a wide area network; and

e) providing at least one electrode in electrical contact with said pulse generator and adapted to be in contact with at least one of the sacral plexus or branches, inferior hypogastric plexus or branches, superior hypogastric plexus or branches in a patient to provide said neuromodulation therapy.

10. The method of claim 9, wherein said pulse generator consists of one from a group comprising of:

an implanted stimulus-receiver with an external stimulator;

an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator;

a programmer-less implantable pulse generator (IPG) which is operable with a magnet;

a programmable implantable pulse generator;

a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and

an IPG comprising a rechargeable battery.

11. A method of claim 9, wherein said plexuses or their branches or portion thereof in a patient further comprises, at least one of pudendal nerve or its branches or portion thereof, cavernous nerve or its branches or portion thereof, prostatic plexus nerve or its branches or portion thereof, sacral splanchnic nerve or its branches or portion thereof, or pelvic splanchnic nerve or its branches or portion thereof, or sacral nerves S1, S2, S3, or S4.

12. A method of claim 9, wherein said electrical pulses are provided for unidirectional neuromodulation therapy.

13. A method of claim 9, wherein said electrical pulses are provided at any point along the length of said plexuses or their branches or portion thereof.

14. A system of providing pulsed electrical stimulation to at least one of sacral plexus, inferior hypogastric plexus, supereior hypogastric plexus or their branches or portion thereof in a patient, for treating or alleviating the symptoms for at least one of erectile/sexual dysfunction, prostatitis, pelvic pain, and pain originating from prostatitis pathology, comprising:

a) a microprocessor based pulse generator;

wherein said pulse generator comprises at least one predetermined program to deliver said electrical pulses;

b) means for programming said pulse generator; and

c) a lead in electrical contact with said pulse generator;

wherein said lead comprising at least one electrode adapted to be in contact with at least one of said plexuses or their branches or portion thereof in a patient;

d) telemetry means for remote two way communication with said pulse generator over a wide area network.

15. A system of claim 14, wherein said plexuses or their branches or portion thereof in a patient further comprises, at least one of pudendal nerve or its branches or portion thereof, cavernous nerve or its branches or portion thereof, prostatic plexus or its branches or portion thereof, sacral splanchnic nerve or its branches or portion thereof, or pelvic splanchnic nerve or its branches or portion thereof, or sacral nerves S1, S2, S3, or S4.

16. A system of claim 14, wherein said pulse generator consists of one from a group comprising of:

an implanted stimulus-receiver with an external stimulator;

an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator;

a programmer-less implantable pulse generator (I PG) which is operable with a magnet;

a programmable implantable pulse generator;

a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and

an IPG comprising a rechargeable battery.

17. A system of claim 14, wherein said telemetry means is further utilized to remotely said electrical pulses and interrogation of said pulse generator.

18. A system of claim 14, wherein said electrical pulses are provided for unidirectional stimulation.

19. A system of claim 14, wherein said electrical pulses are provided at any point along the length of at least one of said plexuses or their branches or portion thereof.

20. A system of claim 14, wherein said predetermined program(s) comprises:

a) at least one variable component selected from a group comprising consisting of pulse amplitude, pulse width, pulse frequency, ON-time, and OFF-time; and

b) controls said variable component of said electric pulses.

21. A system of claim 14, wherein said predetermined program(s) can be modified.

22. The system of claim 14, wherein said lead comprises a lead body with insulation selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

23. The system of claim 14, wherein said at least one electrode consists from a group comprising, spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.

24. The system of claim 23, wherein said electrodes are made from material from one of a group comprising of pure platinum, platinum-iridium alloy, platinum-iridium coated with titanium nitride, or carbon.