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

• US 7,330,762 B2
• Filed: 06/07/2004
• Issued: 02/12/2008
• Est. Priority Date: 06/07/2004
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Primary Examiner(s): Bockelman; Mark
• Assistant Examiner(s): Bertram; Eric D.
• Application Number:
  US10/862,630
• Publication Number:
  US 20050131484A1
• Time in Patent Office: 1,345 Days
• Field of Search: 607 39- 41, 607/46, 607/59, 607/60
• 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, comprising the steps of:

providing an implantable stimulator to provide electrical pulses, wherein said implantable stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator adapted to be inductively coupled to said stimulus-receiver module; and

providing at least one implanted lead in electrical contact with said implanted stimulator, and at least one electrode adapted to be in contact with at least one of sacral plexus, inferior hypogastric plexus, and superior hypogastric plexus or their branches or portion thereof,

whereby pulsed electrical stimulation is provided to at least one of sacral plexus, inferior hypogastric plexus, and superior hypogastric plexus or their branches or portion thereof.

2. The method of claim 1, wherein said plexuses or their branches or portion thereof in a patient further comprises, at least one of a pudendal nerve or its branches or portion thereof, a cavernous nerve or its branches or portion thereof, a prostatic plexus nerve or its branches or portion thereof, a 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. The method of claim 1, wherein said implantable stimulator further comprises telemetry means, wherein said telemetry means allow said pulse generator to be remotely interrogated.

4. The method of claim 1, wherein said implantable stimulator further comprises telemetry means, wherein said telemetry means allow said electrical pulses to be remotely controlled.

5. The method of claim 1, wherein said pulsed electrical stimulation is provided to said nerves for unidirectional stimulation.

6. The method of claim 1, wherein said pulsed electrical stimulation is provided at any point along the length of said plexuses or their branches or portion thereof.

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

providing an implantable stimulator to provide electrical pulses, wherein said implantable stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator adapted to be inductively coupled to said stimulus-receiver module; and

providing at least one implanted lead in electrical contact with said implanted stimulator, and at least one electrode adapted to be in contact with at least one of sacral plexus, inferior hypogastric plexus, and superior hypogastric plexus or their branches or portion thereof,

whereby electrical pulses are provided for treating or alleviating the symptoms for at least one of erectile/sexual dysfunction, prostatitis, pelvic pain, or pain originating from prostatitis pathology.

8. The method of claim 7, 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.

9. The method of claim 7, wherein said neuromodulation therapy is provided by providing electrical pulses at any point along the length of said plexuses or their branches or portion thereof.

10. A system for 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, comprising:

providing an implantable stimulator to provide electrical pulses, wherein said implantable stimulator comprises a pulse generator module and a stimulus-receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator adapted to be inductively coupled to said stimulus-receiver module; and

providing at least one implanted lead in electrical contact with said implanted stimulator, and at least one electrode adapted to be in contact with at least one of sacral plexus, inferior hypogastric plexus, supereior hypogastric plexus or their branches or portion thereof,

whereby said system can provide 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, or pain originating from prostatitis pathology.

11. The system of claim 10, 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.

12. The system of claim 10, wherein said implantable stimulator comprises a rechargeable battery.

13. The system of claim 10, wherein said implantable stimulator further comprises network telemetry, wherein said network telemetry allows said stimulation and/or interrogation of said implantable stimulator to be remotely controlled.

14. The system of claim 10, wherein said pulsed electrical stimulation is provided for unidirectional stimulation.

15. The system of claim 10, wherein said pulsed electrical stimulation is provided at any point along the length of at least one of said plexuses or their branches or portion thereof.

16. The system of claim 10, wherein said implantable lead comprises a lead body with insulation selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

17. The system of claim 10, wherein said at least one electrode is from a group comprising, spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.

18. The system of claim 17, 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.