Method for conditioning pelvic musculature using an implanted mi

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

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607 40, 607 61, A61N 136

Patent

active

060615966

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The present invention relates to a system and method for conditioning the pelvic musculature using one or more implanted microstimulators, and more particularly to a system and method for treating urinary incontinence using a radio-frequency-controlled implanted microstimulator.
Urinary incontinence is an enormous medical and social problem, affecting 8% of people in industrialized countries. Expenditures on its treatment are conservatively estimated to be over 10 billion dollars. Nevertheless, aggressive therapies for this condition are used to treat only a small part of the affected population, and much of the market is driven by the need for absorptive products rather than state-of-the-art devices.
Incontinence can be divided into at least three major categories of pathophysiology: contract at all or adequately for substantial emptying, so that urine accumulates until it overflows. This commonly occurs in spinal cord injury. sphincteric muscles, which are unable to stop the forceful expulsion of urine during transient increases in intra-abdominal pressure such as during coughing and lifting. This commonly occurs in women following childbirth and/or menopause. and/or sphincteric muscles producing a compelling feeling that the bladder needs to be emptied even when it contains little urine. This afflicts both men and women and probably arises from a variety of poorly understood dysfunctional reflexes.
It is has been observed over the past 50 years or so that conditioning exercises of the pelvic musculature can produce a reduction of stress incontinence in a majority of women who undertake this treatment. Pelvic conditioning therapies could potentially assist a large proportion of the more than 6 million women affected by stress incontinence in the United States alone. However, such exercises have not proved easy for many women to perform by voluntary contraction of the relevant muscles. Thus, electrical stimulation has been used to force contraction of the relevant muscles, and thereby achieve the desired muscle conditioning exercises.
Prior art devices that provide electrical stimulation to condition the pelvic musculature are based on the use of transcutaneous electrical stimulators which exercise pelvic muscles using externally-controlled regimes. While these prior art transcutaneous devices, introduced into the vagina or anal canal, have proven to be effective, they are often disliked by patients because of the associated embarrassment and sanitary problems. Further, in addition to stimulating the motor nerves, transcutaneously applied electrical currents necessarily stimulate the sensory nerves of the overlying skin, producing unpleasant sensations. It is thus apparent that there is a need in the art for a system and/or method for achieving the benefits of electrical stimulation of the pelvic musculature without the attendant problems associated with transcutaneous devices.
Stimulation of the bladder, sphincter and/or adjacent pelvic musculature and cutaneous nerves may also cause a reduction in the spontaneous sensations and contractions associated with urge incontinence, which is often combined with stress incontinence. The neural mechanism is unclear, but is believed to relate to a general property of neural reflect pathways that they can drift into states of hypersensitivity or spasticity as a result of various nonspecific insults and dysfunctional patterns of usage. Electrical stimulation may give rise to inhibitory neural activity that breaks the cycle of spasticity during a particular bout of urge incontinence. Repeated application of such stimulation may permit the patient to resist inappropriate urges to empty the bladder, thereby rebuilding normal bladder capacity and reducing the frequency of sensation that the bladder needs to be emptied. Repeated electrical stimulation may also lead to a reduction in the hypersensitivity of the neural pathways responsible for spontaneous sensations and contractions and a concomitant reduction in the incidence and/or severity o

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