Neuromodulation and associated systems and methods for the treatment of sexual dysfunction

• US 9,974,593 B2
• Filed: 03/07/2013
• Issued: 05/22/2018
• Est. Priority Date: 03/08/2012
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Barman, Neil
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vahdat, Khadijeh
• Application Number:
  US14/379,902
• Publication Number:
  US 20150088112A1
• Time in Patent Office: 1,902 Days
• Field of Search: 606 28- 50
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter

Abstract

Methods for treating erectile dysfunction with therapeutic neuromodulation and associated systems and methods are disclosed herein. Erectile dysfunction can be characterized by the inability to develop and/or maintain an erection during sexual arousal or activity. One aspect of the present technology is directed to methods that at least partially inhibit sympathetic neural activity in nerves innervating the penis of a patient. Sympathetic drive in the patient can thereby be reduced in a manner that treats the patient for erectile dysfunction. Sympathetic nerve activity can be modulated along afferent and/or efferent pathways. The modulation can be achieved, for example, using an intravascularly positioned catheter carrying a therapeutic assembly, e.g., a therapeutic assembly configured to use electrically-induced, thermally-induced, and/or chemically-induced approaches to modulate the nerves.

Claims

1. A method, comprising:

introducing a neuromodulation assembly at a distal portion of a treatment device proximate to a dorsal nerve of a penis of a human patient diagnosed with erectile dysfunction or low libido, wherein introducing the neuromodulation assembly comprises extracorporeally positioning the neuromodulation assembly on penile tissue;

partially disrupting function of the dorsal nerve by applying thermal energy to the dorsal nerve via the neuromodulation assembly, wherein thermal energy is applied via the neuromodulation assembly through penile skin; and

removing the neuromodulation assembly from the patient after treatment,

wherein partial disruption of the function of the dorsal nerve therapeutically treats the diagnosed erectile dysfunction or low libido.

2. The method of claim 1 wherein the patient is diagnosed with low libido, and wherein partial disruption of the function of the dorsal nerve reverses low libido in the patient.

3. The method of claim 1 wherein partially disrupting function of the dorsal nerve by applying thermal energy comprises at least partially ablating the dorsal nerve via thermal energy from the neuromodulation assembly.

4. The method of claim 1 wherein partially disrupting function of the dorsal nerve in a manner that therapeutically treats the diagnosed erectile dysfunction or low libido comprises increasing a frequency of penile erections in the patient.

5. The method of claim 4 wherein increasing a frequency of penile erections in the patient is self-reported by the patient within about three months to about 12 months after reducing sympathetic neural activity in the patient.

6. The method of claim 4 wherein increasing a frequency of penile erections is assessed using a nocturnal penile tumescence test.

7. The method of claim 1 wherein partially disrupting function of the dorsal nerve in a manner that therapeutically treats the diagnosed erectile dysfunction or low libido comprises reducing a number of incidences where the patient reports impotence or premature loss of erection by at least about 20%.

8. The method of claim 1 wherein partially disrupting function of the dorsal nerve in a manner that therapeutically treats the diagnosed erectile dysfunction or low libido comprises reducing an average patient-perceived or clinician-observed frequency of impotence or premature detumescence during sexual activity within about three months to about 12 months after reducing sympathetic neural activity in the patient.

9. The method of claim 1 wherein partially disrupting function of the dorsal nerve by applying thermal energy to the dorsal nerve via the neuromodulation assembly comprises applying ultrasound energy via the neuromodulation assembly.