Neuromodulation stimulation for the restoration of sexual function

Abstract

Systems and methods use an implantable pulse generator system for neuromodulation stimulation to treat sexual dysfunction by the unilateral or bilateral stimulation of the left and / or right branches of the dorsal genital nerves using one or more leads and electrodes implanted in adipose or other tissue in the region at or near the pubic symphysis. A neuromodulation stimulation waveform includes at least a variable frequency component and / or a variable duty cycle component and / or a variable amplitude component and / or a variable pause component to ward off habituation.

Description

RELATED APPLICATIONS [0001] This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 149,654, filed 10 Jun. 2005, and entitled “Systems and Methods for Bilateral Stimulation of Left and Right Branches of the Dorsal Genital Nerves to Treat Dysfunctions Such as Urinary Incontinence.” This application also claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 578,742, filed Jun. 10, 2004, and entitled “Systems and Methods for Bilateral Stimulation of Left and Right Branches of the Dorsal Genital Nerves to Treat Dysfunctions, Such as Urinary Incontinence,” which are all incorporated herein by reference. [0002] This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 150,419, filed 10 Jun. 2005, and entitled “Lead and Electrode Structures Sized and Configured for Implantation in Adipose Tissue and Associated Methods of Implantation,” which is incorporated herein by reference. [0003] This applicat...

AI Technical Summary

Benefits of technology

[0027] The implantable stimulation system will use electrical stimulation of the dorsal genital nerve of either the male or the female to provide a sexual restoration function on-demand with a

Problems solved by technology

While existing systems and methods can provide remarkable benefits to individuals requiring neuromodulation stimulation, many limitations and issues still remain.

For example, existing systems can often require the user to wear an external stimulator, which may provide a positive functional outcome, but may also negatively affect quality of life issues.

Although these modalities have shown the ability to provide a neuromodulation stimulation with positive effects, they have received limited acceptance by patients because of their limitations of portability, limitations of treatment regimes, and limitations of ease of use and user control.

Erectile Dysfunction is common problem affecting men and is defined as the inability to achieve or maintain a penile erection sufficient for sexual activity.

It would cost $3.5 billion per year if only one fifth of Americans with ED were treated with the first line of treatment (oral therapy such as PDE-5 inhibitors), and the cost for the second line of treatment (such as injection or transurethral administration of alprostadil) is approximately twice as expensive.

Thus, ED is often associated with poor self-image, depression, and it can affect interpersonal relationships and lead to increased mental stress.

Persons with vasculogenic erectile dysfunction are unable to achieve penile erection due to either insufficient arterial blood flow or insufficient venous occlusion or both.

Methods of treatment for erectile dysfunction are available but are either often discontinued due to loss of efficacy or side effects or reserved as a final recourse requiring irrevocable damage.

The second-line treatments are usually effective in 33% to 70% of men, but they are also later discontinued by over half of the patients, often due to side effects such as pain or local damage at the site of administration.

However, side effects of pain and local damage are associated with the second line of treatment, and at least half of the men discontinue this form of therapy.

Yet, implantation of a penile prosthesis is reserved for the final method of treatment because the implantation causes permanent (irrevocable) damage to the erectile tissue resulting in the loss of any future erection if the implant is removed.

These animal experiments demonstrate that DNP stimulation can evoke a reflex erection, but they do not determine if the reflex erection is comparable to the erections evoked by the present treatment methods.

Unlike the second line of treatment, this approach will not require a constrictive ring, needle insertion, or urethral-suppository insertion, which can cause local injury prior to each erection and lead to discontinuation of treatment.

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