Devices and methods for treatment of incontinence

#1. Field of the Invention

#The invention relates to devices and methods for treating incontinence. More specifically, particular embodiments of the invention use a variable control vacuum and/or vibratory device or other device to apply suction or other force to the male or female genital region, e.g. the region of the female urethral opening, the clitoral region and/or the vaginal region, or the male penile region.

#2. Description of Related Art

#Embodiments of the invention will be described with respect to the figures, in which like reference numerals denote like elements and in which:

#FIG. 1 is a perspective, schematic view of an incontinence treatment device according to an embodiment of the invention;

#FIG. 2 is a top view of a vacuum application mechanism for use with the embodiment of FIG. 1;

#Devices according to aspects of the invention physically stimulate sacral nerves and nerve roots and/or other nerves or areas to reduce or eliminate urinary incontinence, e.g. stress, urge, and/or overflow incontinence, and/or fecal incontinence. Embodiments of the invention also tend to promote blood flow to the genital region, e.g. to the clitoris of a female patient or the penis of a male patient, to also treat female sexual dysfunction or male erectile dysfunction if needed. Non-pharmacological, non-invasive treatment of incontinence, especially (although not limited to) urge incontinence, is achieved in a previously unknown and advantageous manner.

#Embodiments of the invention are expected to become a primary therapy for treating overactive bladder symptoms or similar incontinence symptoms, because of the many advantages provided over current treatments. Kegel muscle exercises, although often perceived useful for treating incontinence symptoms, can be difficult to implement in practice, in part because many patients have difficulty knowing which muscle to contract. Biofeedback or other treatments using vaginal probes or the like are often perceived as uncomfortable or invasive. Treatment using e.g. an electromagnetic chair or other large or complex appliance requires an office visit and involves corresponding inconvenience and expense. Other treatments are surgically invasive and thus even more expensive, inconvenient and prone to negative side effects. Pharmacological treatments, of course, also can produce negative side effects. Embodiments of the invention, on the other hand, are non-invasive, non-pharmacological, easy-to-use in the privacy of the patient's home, free of serious risk factors, and provide other advantages.

#As referenced above, it is generally accepted that mild electrical stimulation of the sacral nerves in the nerve root or at the peripheral sciatic nerve can be used in the treatment of urinary incontinence. The sacral nerves influence the behavior of e.g. the external urethral orifice, the bladder, and the muscles of the pelvic floor. It is also generally accepted that clitoral stimulation and tumescence are important aspects of female sexual arousal. Tumescence or engorgement occurs when the clitoris fills with blood. During sexual arousal, the smooth muscles within the clitoris relax and the arterial wall dilates. This causes an increase in blood flow leading to tumescence and extension of the glans clitoris. Although a physical relationship exists between proper urinary function and sexual stimulation (e.g. urination is difficult or impossible during periods of sexual stimulation), it has not been generally known in theory or practice to treat urinary and/or fecal incontinence by physically stimulating sacral nerves and/or sacral nerve roots by using a device that also can successfully treat female sexual arousal disorder, or male erectile dysfunction, by applying suction or pressure to or otherwise stimulating e.g. the female genitalia or genital region, or by applying suction or pressure to or otherwise stimulating the male penis by using e.g. a vacuum cylinder.