Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
1999-05-03
2003-03-11
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C128S885000, C128SDIG008
Reexamination Certificate
active
06530879
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an intravaginal set, used in the case of prolapse of the urogenital organs and urinary stress incontinence, or during the period when a therapeutic intravaginal insert for treatment of static disorders of the urogenital organs and urinary stress incontinence is not currently inserted and the method of the treatment with usage of this intravaginal set, and application thereof.
Aging and past parturitions result in weakening and elongation of the perineum muscles leading to the prolapse of urogenital organs and other anatomical disorders.
Once extended, muscles become weaker and weaker which subsequently results in progress of prolapse up to transvaginal eversion of the uterus. As the vaginal canal is the “locus minoris resistentiae” in the pelvic floor, walls of the vagina may become the ring of hernia (cystocele, uretrocele and rectocele). In the course of progressive prolapse of urogenital organs, discomfort in lower abdominal part intensifies, from a feeling of “heaviness” to one of pain, and urinary stress incontinence becomes apparent.
Prolapse of the urogenital organs causes a decrease in the distance between the uterine cervix and the vaginal inlet, descent of the anterior wall of the vagina along with the urinary bladder and urethra (the cysto-urethral angle becomes more obtuse), and dislocation of the urethra to outside an operation range of the intra-abdominal pressure.
This results in impaired blood outflow from the urogenital organs due to venous constriction (low-pressure blood vessels).
In less advanced cases of the urogenital prolapse, special therapeutic exercises are recommended to strengthen the pelvic floor muscles.
The physical exercises may only increase the efficiency of the cross-striated muscles, i.e. muscles dependent on the person's own physical characteristics, whereas the urogenital organs equilibrium is independent of the patient's muscle responses since it is controlled by the autonomous nervous system. Strong muscles build the urinary bladder, urethra, internal sphincter muscle of urethra, and muscles in uterine ligaments fix the uterus in its normal position.
A significant progress in the treatment of static disorders of the urogenital organs has been made by development of a therapeutic insert (patent specification No. RP 138406), consisting of a hollow ball with a string attached freely outside the ball, and a smaller ball placed freely inside the hollow ball. This device generates mechanical impulses stimulating contractions of surrounding muscles, both smooth, and cross-striated. A metal ball placed for free movement in the intravaginal therapeutic insert generates mechanical impulses by hitting its cap as a result of translocation to the center of gravity while the patient is walking. The mechanical impulse stimulates muscular contraction. Regular muscular exercise results in muscle hypertrophy and an increase in muscular force. The therapeutic insert may be used twice a day, over a period of about 30 minutes.
Prolonged application longer than 30 minutes leads to muscular overstrain and abdominal pain Use of the therapeutic insert every day over a period of three months achieved satisfactory therapeutic results in the treatment of minor prolapse of the urogenital organs (grade I), while in more advanced cases (grades II, III, IV) no improvement was observed.
The most probable explanation of this result is that in the case of more advanced urogenital prolapse the uterus lowers during intervals between use of the therapeutic device, resulting in unfavorable effects (isometric contraction, passive congestion).
When conservative therapy is ineffective, the reconstructive surgery is performed to restore the normal position of the urogenital organs. Different strategies of therapeutic management are used, depending on symptoms, age and progress of the illness. From among around 200 modifications applied to correct the position of the urogenital organs, the basic management consists in shortening of muscles and ligaments. Such therapeutic management ameliorates the position of the organs, but it does not restore the normal muscular function and thus a lasting and complete recovery.
In the case of contraindications for surgery, a device-prostheses may be used to ensure a normal position of the urogenital organs.
One such device is the well-known intravaginal disc for support of a lowered or prolapsed uterus. This disc is applied in a manner such that its ring surrounds the uterine cervix, thus preventing uterus prolapse by extension of the vaginal wall in the area of the posterior vaginal fornix. A disadvantage of this design includes difficulties in application and removal. These problems have limited use of this device. Also, as the disc is placed in the upper part of the vagina, it does not transmit the contraction of the levator ani muscle. Thus, the uterus is not elevated. The British patent application discloses a plastic planar arc, the wider arm of which rests on the public symphysis, while the second, narrow arm presses the urethra against the urinary bladder. The maximum time for intravaginal application is 2 hours, which limits the usefulness of this device. The mode of action of this device is local compression of the urethra, which may lead to inflammation and decubitus ulcers.
There is also a well-known disposable vaginal pack (made in Germany), which is placed in the vagina for a period of up to 8 hours. Its mode of action is a mild compression of the urethra and adjustment to the vagina after soaking with water before intravaginal application. This vaginal pack, however, does not provide the desired corrective functions, and may cause an inflammatory state in the case of prolonged intravaginal presence. Soaking with vaginal secretion may result in distension of the vagina leading to progressive prolapse of the uterus and urinary bladder.
OBJECT OF THE INVENTION
The object of the invention is to provide an intravaginal set and a method of treatment using the set to obtain permanent optimal positioning of the uterus and urinary bladder.
BRIEF DESCRIPTION OF THE INVENTION
An intravaginal set is provided to be used in the treatment of prolapse of urogenital organs and urinary stress incontinence, or in the period of intervals in women when the intravaginal therapeutic insert for treatment of static disorders of the urogenital organs and urinary stress incontinence is not currently inserted. The therapeutic insert comprises a hollow plastic ball with string attached and freely moving outside the ball, a smaller ball is placed to be freely movable inside the hollow plastic ball, which smaller ball has a weight adequately adjusted to generate mechanical impulses stimulating alternate contractions of the muscles. The set also includes a subset of intravaginal corrective inserts and an intravaginal measuring subset for determining the size of the insert. The subset of intravaginal corrective inserts has at least two balls of different diameters, ranging between the minimal and maximal woman patent vaginal diameter. Each ball is preferably hollow, and each ball has the loosely hanging string. Each ball is preferably made of medical material, such as polycarbonate or methyl methacrylate, while the intravaginal measuring subset comprises at least two balls made of metal or plastic with graduated diameters corresponding to graduated diameters of the balls of subset of intravaginal corrective inserts. The measuring balls, instead of having the loosely hanging string, have a rigidly mounted, preferably linearly scaled, slat for measurement of optimal diameter and depth of localization of the insert in the vagina, depending on actual and individual anatomical conditions of urogenital organs of the woman being treated.
The invention also is directed to a method of treatment of prolapse of urogenital organs and urinary stress incontinence or in the period of intervals in women when the intravaginal therapeutic insert for treatment of static disorders of the urogenital organs and u
Adamed, SP. Z.O.O.
Darby & Darby
Lacyk John P.
LandOfFree
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