Systems and methods for the treatment of bladder dysfunctions using neuromodulation

Abstract

Systems and Methods treat bladder dysfunctions using neuromodulation stimulation. Bladder emptying through stimulation of urethral afferents, and continence through stimulation of the dorsal genital nerve, is provided with one or more implanted pulse generators and one or more leads. A simple surgical procedure preserves all existing functions. A stimulating catheter is provided to be used as a clinical screening tool. The stimulating catheter is used to measure bladder pressures and stimulate the urethra at the same time.

Description

RELATED APPLICATION[0001]This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 931,263, filed May 22, 2007, and entitled “Systems and Methods for the Treatment of Bladder Dysfunctions Using Neuromodulation Stimulation” which is incorporated herein by reference.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH[0002]This invention was made with government support under grant number 1RNS055393-01 awarded by the National Institutes of Health, through the National Institute of Neurological Disorders and Stroke. The Government may have certain rights in the invention.FIELD OF THE INVENTION[0003]This invention relates to systems and methods for stimulating nerves and / or muscles in animals, including humans, to treat bladder dysfunctions.BACKGROUND OF THE INVENTIONI. Neuromodulation Stimulation[0004]Neuromodulation stimulation (the electrical excitation of nerves to indirectly affect the stability or performance of a physiological system) can provide function...

AI Technical Summary

Benefits of technology

"The present invention provides a new way to control the bladder through a simple surgical procedure that preserves all existing functions. The system combines bladder emptying through stimulation of urethral afferents and continence through stimulation of the dorsal genital nerve. The stimulation can be adjusted to activate either the urethral or genital pathway for micturition or continence, respectively. The invention also includes a stimulating catheter for measuring bladder pressures and stimulating the ureter at the same time."

Problems solved by technology

While existing systems and methods can provide remarkable benefits to individuals able to be treated with 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 some 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.

Electrical stimulation of urethral afferents may evoke micturition even if some of the neural circuitry is damaged or compromised (e.g., through disease or injury, including spinal cord injury).

The inability to empty the bladder is a significant problem that is not adequately addressed by present treatment options.

Bladder contractions become ineffective in emptying the bladder, leaving a high residual volume.

The urinary system transformed by SCI typically results in additional complications such as ureteric reflux and obstruction, infection of the kidneys, long-term renal damage, episodes of autonomic dysreflexia with dangerous rises in blood pressure, bladder trabeculation, and frequent urinary tract infections.

Furthermore, the loss of control of urinary function alters social relationships and can be personally demoralizing, and it can lead to depression, anger, poor self-image, embarrassment, frustration and can prevent persons from achieving their personal goals.

Presently, self-catheterization proves to be the best non-invasive method to care for lower urinary tract dysfunction, but many persons with lower urinary tract dysfunction sustain multiple infections per year, and persons with SCI often lack the physical ability to catheterize themselves.

Alternative methods have been developed to empty the bladder by preventing the sphincter from closing the urethra, but most of them, including sphincterotomy, sphincter paralysis, and urethral stenting, leave the person incontinent and lead to further complications.

Other techniques, such as balloon dilation, have a low (e.g., 15 percent) success rate, and presently, no techniques provide effective bladder emptying without the secondary consequences that limit widespread acceptance among the patient population.

It has been found that few people elect to receive the VOCARE system because it requires 1) a time-consuming (e.g., more than eight hours), invasive surgical procedure and 2) an irreversible nerve transection, resulting in the loss of sexual function and reflex defecation.

Presently, it is difficult to determine how effective a VOCARE system may be prior to implantation.

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