Systems and methods for treating sexual disorders using electro-stimulation

• US 10,300,279 B2
• Filed: 10/25/2017
• Issued: 05/28/2019
• Est. Priority Date: 10/13/2014
• Status: Active Grant

• Current Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Original Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Inventors: Fraga {grave over (d)}a Silva, Rodrigo Araujo, Stergiopulos, Nikolaos
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/793,781
• Publication Number:
  US 20180043164A1
• Time in Patent Office: 580 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. A method of treating a sexual disorder, the method comprising:

placing an array of electrodes adjacent a prostate or where a native prostate was located prior to prostatectomy, the array of electrodes disposed on at least one flat flexible substrate;

selectively activating subsets of the array of electrodes to empirically determine an identity of a subset of the array of electrodes comprising the at least one electrode;

storing the identity of the empirically determined subset of the array of electrodes; and

supplying electrical stimulation via the empirically determined subset of the array of electrodes to stimulate a pelvic plexus and thereby at least one cavernous nerve to cause an erection.

2. The method of claim 1, wherein the at least one flat flexible substrate is sized and shaped to abut at least a portion of the pelvic plexus and configured to bend to conform to an anatomical shape of the portion of the pelvic plexus.

3. The method 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 and each electrode is individually selectable.

4. The method 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.

5. The method of claim 4, 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 supplying the electrical stimulation via the empirically determined subset of the array of electrodes comprises supplying the electrical stimulation to one or more electrodes of the first portion and one or more electrodes of the second portion at a same time in a bilateral stimulation manner.

6. The method of claim 1, wherein supplying the electrical stimulation via the empirically determined subset of the array of electrodes comprises initiating a stimulation routine executed by an implantable processor operatively coupled to the array of electrodes.

7. The method of claim 6, wherein the stimulation routine is initiated responsive to a command wirelessly transmitted by an external patient controller to the implantable processor.

8. The method of claim 6, wherein the stimulation routine specifies one or more of pulse duration, frequency of alternating current, voltage, current, or period of stimulation sufficient to cause the erection.

9. The method of claim 6, further comprising adjusting the stimulation routine by adjusting stimulation parameters at the implantable processor responsive to one or more commands wirelessly received.

10. The method of claim 9, further comprising wirelessly sending the one or more commands by an external physician controller or an external patient controller after supplying the electrical stimulation.

11. The method of claim 1, wherein selectively activating subsets of the array of electrodes is executed via an external physician controller operatively coupled to the array of electrodes.

12. The method of claim 1, wherein selectively activating subsets of the array of electrodes comprises executing a scanning protocol via an implantable processor operatively coupled to the array of electrodes.

13. The method of claim 12, wherein executing the scanning protocol comprises activating varying subsets of the array of electrodes in a predetermined manner to determine the empirically determined subset of the array of electrodes.

14. The method of claim 13, wherein activating the varying subsets of the array of electrodes in the 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.

15. The method of claim 13, wherein activating the varying subsets of the array of electrodes in the predetermined manner comprises activating a first subset of the array of electrodes at a first time and activating either the first subset of the array of electrodes at different stimulation parameters or a second subset of the array of electrodes at a same or different stimulation parameters.

16. The method of claim 1, further comprising anchoring the array of electrodes to maintain the array of electrodes in contact with the pelvic plexus.

17. The method of claim 16, wherein anchoring the array of electrodes comprises anchoring the array of electrodes with sutures or biocompatible glue.

18. The method of claim 1, further comprising:

receiving an electrical signal emitted by one or more external electrodes disposed on a skin of a penis of the patient via at least one electrode of the array of electrodes; and

recording and storing information indicative of the received electrical signal.