Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Patent
1996-06-24
1998-09-01
Lacyk, John P.
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
607116, 600373, A61N 100
Patent
active
058005013
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to an intravaginal or intrarectal electrode for electro-stimulation and/or bio-feedback monitoring of the pubo-visceral musculature and most especially the pelvic floor primarily as a treatment for various pelvic floor dysfunctions including urinary stress incontinence.
BACKGROUND TO THE INVENTION
Electro stimulation of the pelvic floor muscle is a technique that has been used for many years now to treat urinary incontinence, where the patients have weak or inactive muscles closing the urethra whereby control of voiding of the contents of the bladder is lost. Electro-stimulation has been found to be effective in increasing muscle strength and the bio-feedback monitoring of muscular activity is valuable in assessment and re-education of the patient for correct pelvic floor contraction.
For the purposes of electro stimulation and bio feedback monitoring an extensive range of intravaginal and intrarectal electrode probes exist.
Both of these techniques require an intra-vaginal or intra-rectal electrode. Stimulation requires an electrode that will deliver an appropriate stimulus to the pelvic floor musculature at a depth of approximately 3.5 to 5 cms from the introitus (entrance to the vagina) and similarly, a bio-feedback electrode will be required to pick up the natural electrical activity of the muscle for display on a bio-feedback monitor.
Both techniques require a sound interface between the electrode and the muscle. A sufficient surface area of the conductive part of the electrode is required to allow safe and comfortable stimulation and, in bio-feedback, the conductive area must be so shaped and positioned to provide a sound and interference-free signal to be monitored.
Seemingly without exception, however, these conventional electrode probes are of a geometry whereby they are not firmly held within the vagina or rectum when inserted and are susceptible to expulsion by the muscular contraction. Inevitably, therefore, these conventional electrode probes are largely limited to use in a clinical environment where they are held in place and generally require the patient to be recumbent during their use. They are largely unsuited for ambulatory use whereby the patient can remain mobile and are especially troublesome for the many patients who are young mothers who do not have the time or opportunity to sit or lie down for sessions which frequently last for half an hour at intervals several times daily. Furthermore, in some treatment protocols it is necessary for low level stimulation to be applied for several hours at a time. It will be appreciated, therefore that the existing electrodes for pubo-visceral muscle stimulation are subject to an extremely inconvenient drawback.
It is a general objective of the present invention to overcome the above problem to provide an intravaginal or intrarectal electrode suitable for ambulatory use and to improve the interfacing between the electrode and the muscle for increased operational efficiency.
SUMMARY OF THE INVENTION
According to a first aspect of the present invention there is provided an intravaginal or intrarectal electrode for electro-stimulation and/or bio feedback monitoring of muscle activity, which electrode comprises:
a pair of electrode lines each comprising a lead with an electrode terminus; and
probe body having an enlarged head portion to seat within the vagina or the rectum and carrying at least one of the electrode terrini and having at least one longitudinal concave surface extending for a majority of the length of the probe body head portion, a narrower neck portion adapted to seat at the introitus of the vagina or of the rectum, and handle means extending from the neck portion to enable the probe body head and neck to be inserted into and withdrawn from the vagina or the rectum.
Advantageously either the neckward end of the probe body head portion or the apex, end remote from the neck, of the probe body head portion is provided with a gap whereby the opposing side wall lengths of the probe
REFERENCES:
patent: 659409 (1900-10-01), Mosher
patent: 4881526 (1989-11-01), Johnson et al.
patent: 5046511 (1991-09-01), Maurer et al.
B.V. Enraf-Nonius Delft--Advertisement/Trade publication entitled: "The Hygienic Solution for Incontinence", date unknown.
EuroSurgical Limited--Advertisement/Trade Publication entitled: "INNOVA Feminine Incontinence Treatment System Design Rationale", date unknown.
Lacyk John P.
Ruddy David M.
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