Systems and methods for treating sexual disorders using electro-stimulation

• US 9,821,163 B2
• Filed: 10/12/2015
• Issued: 11/21/2017
• Est. Priority Date: 10/13/2014
• Status: Active Grant

• Current Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Original Assignee: Ecole Polytechnique Federal de Lausanne
• Inventors: Fraga Da Silva, Rodrigo Araujo, Stergiopulos, Nikolaos
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/880,903
• Publication Number:
  US 20160101288A1
• Time in Patent Office: 771 Days
• Field of Search: 607 39
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

Systems and methods are provided for treating a sexual disorder such as erectile dysfunction (ED) or female sexual arousal disorder (FSAD). An electrical stimulation system may include an implantable stimulation unit, an external patient controller, and an external physician controller. The implantable stimulation unit has an array of electrodes disposed on one or more flexible substrates configured to conform to a patient'"'"'s anatomy at the pelvic plexus. Post-implantation, the physician controller may direct the stimulation unit to stimulate with select electrode(s) of the array to determine which electrode configuration provides optimal sexual arousal. The patient controller may be used to cause the stimulation unit to stimulate using the optimal electrode configuration at desired times.

Claims

1. An electrical stimulation system for treatment of erectile dysfunction in a patient, the system comprising:

an implantable stimulation unit comprising;

an array of electrodes disposed on at least one flat flexible substrate sized and shaped to abut at least a portion of a pelvic plexus of a patient adjacent a prostate or where a native prostate was located prior to prostatectomy and configured to bend to conform to an anatomical shape of the portion of the pelvic plexus;

a programmable controller operatively coupled to the array of electrodes, the programmable controller including a stimulation circuit, a nonvolatile memory and a microprocessor coupled to the stimulation circuit and the nonvolatile memory,

wherein the nonvolatile memory stores an identity of an empirically determined subset of the array of electrodes post implantation of the implantable stimulation unit and a stimulation routine used by the microprocessor to supply electrical stimulation via the stimulation circuit and the pelvic plexus to at least one cavernous nerve sufficient to cause an erection; and

an external patient controller configured to selectably activate the implantable stimulation unit responsive to a patient input; and

an external physician controller configured to selectively activate desired subsets of the array of electrodes to determine the empirically determined subset of the array of electrodes post implantation of the implantable stimulation unit and to cause the nonvolatile memory of the implantable stimulation unit to store the stimulation routine used by the microprocessor post implantation of the implantable stimulation unit.

2. The electrical stimulation system of claim 1, wherein the implantable stimulation unit and the external patient controller communicate wirelessly.

3. The electrical stimulation system of claim 2, wherein the implantable stimulation unit contains a first transceiver and the external patient controller contains a second transceiver.

4. The electrical stimulation system of claim 3, wherein wireless communications between the first and second transceivers are encrypted.

5. The electrical stimulation system of claim 4, wherein the external patient controller comprises a smartphone, laptop, tablet, or smartwatch programmed to communicate with the implantable stimulation unit.

6. The electrical stimulation system of claim 5, wherein the first and second transceivers employ IEEE 802.11 or Bluetooth communications schemes.

7. The electrical stimulation system of claim 3, wherein the implantable stimulation unit and the external physician controller communicate wirelessly.

8. The electrical stimulation system of claim 7, wherein the external physician controller contains a third transceiver.

9. The electrical stimulation system of claim 8, wherein wireless communications between the first and third transceivers are encrypted.

10. The electrical stimulation system of claim 9, wherein the external physician controller comprises a smartphone, laptop, tablet, or desktop computer programmed to communicate with the implantable stimulation unit.

11. The electrical stimulation system of claim 10, wherein the first and third transceivers employ IEEE 802.11 or Bluetooth communications schemes.

12. The electrical stimulation system of claim 1, wherein the external physician controller is configured to selectively activate desired subsets of the array of electrodes to determine the empirically determined subset of the array of electrodes at the time of implantation of the implantable stimulation unit.

13. The electrical stimulation system of claim 1, wherein the external physician controller is configured to selectively activate desired subsets of the array of electrodes to determine the empirically determined subset of the array of electrodes subsequent to implantation of the implantable stimulation unit.

14. The electrical stimulation system of claim 1, wherein the at one least flat flexible substrate comprises a first flat flexible substrate configured to conform to a first half of the pelvic plexus and a second flat flexible substrate configured to conform to a second half of the pelvic plexus.

15. The electrical stimulation system of claim 14, wherein a first portion of the array of electrodes is disposed on the first flat flexible substrate and a second portion of the array of electrodes is disposed on the second flat flexible substrate, wherein the stimulation circuit is configured to cause one or more electrodes of the first portion and one or more electrodes of the second portion to supply electrical stimulation at a same time in a bilateral stimulation manner.

16. The electrical stimulation system of claim 1, further comprising an anchor configured to maintain the at least one flat flexible substrate in contact with the pelvic plexus following radical prostatectomy.

17. The electrical stimulation system of claim 16, wherein the anchor comprises sutures or biocompatible glue.

18. The electrical stimulation system of claim 1, wherein electrodes of the array of electrodes comprise a plurality of rows and a plurality of columns disposed on the at least one flat flexible substrate, such that each electrode is individually selectable.

19. The electrical stimulation system of claim 1, wherein the implantable stimulation unit further comprises a power supply.

20. The electrical stimulation system of claim 19, wherein the power supply is rechargeable.

21. The electrical stimulation system of claim 1, wherein the stimulation routine comprises a pulse duration, frequency, voltage, and current.

22. The electrical stimulation system of claim 21, wherein the parameters of the electrical stimulation may be adjusted post-implantation by the external physician controller.

23. The electrical stimulation system of claim 1, wherein the subset of the array of electrodes comprises one or more electrodes within the array of electrodes.

24. The electrical stimulation system of claim 1, wherein the external physician controller is configured to selectively activate desired subsets of the array of electrodes by causing the microprocessor to execute a scanning protocol stored in the nonvolatile memory to determine the empirically determined subset of the array of electrodes and to cause the nonvolatile memory to store the identity of the empirically determined subset of the array of electrodes.

25. The electrical stimulation system of claim 24, wherein the scanning protocol is configured to cause the microprocessor to supply electrical stimulation via the stimulation circuit by activating varying subsets of the array of electrodes in a predetermined manner to determine the empirically determined subset of the array of electrodes and to cause the nonvolatile memory of the implantable stimulation unit to store the stimulation routine used by the microprocessor.

26. The electrical stimulation system of claim 25, wherein activating varying subsets of the array of electrodes in a predetermined manner comprises activating a first subset of the array of electrodes at a first time and activating a second subset of the array of electrodes at a second time in an interpulse manner.

27. The electrical stimulation system of claim 1, wherein the at least one flat flexible substrate comprises at least one cavity configured to permit connective tissue growth in the at least one flat flexible substrate or through the at least one flat flexible substrate, or both, to anchor the at least one flat flexible substrate adjacent to the pelvic plexus.

28. The electrical stimulation system of claim 1, wherein the electrical stimulation is configured to promote nerve regeneration.

29. The electrical stimulation system of claim 1, wherein the implantable stimulation unit is configured to be implanted using a robotic-guided surgery system.

30. The electrical stimulation system of claim 1, wherein the at least one flat flexible substrate and the programmable controller are each sized and shaped to be implanted through a trocar.

31. The electrical stimulation system of claim 1, wherein at least one electrode of the array of electrodes is configured to receive an electrical signal emitted by one or more external electrodes disposed on a skin of a penis of the patient and the nonvolatile memory of the programmable controller is configured to record and store information indicative of the received electrical signal.