Self-positioning vaginal weight with facilitation

Exercise devices – User manipulated force resisting apparatus – component... – Utilizing weight resistance

Reexamination Certificate

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C482S093000

Reexamination Certificate

active

06183402

ABSTRACT:

The present invention generally relates to strengthening of pelvic floor muscles and more particularly relates to a vaginal weight, a set of vaginal weights and a method of treating incontinence.
Exercising of the striated muscles of the pelvic floor has been used to prevent and treat problems of incontinence for decades. A too slack and weak pelvic floor musculature frequently results in a state of incontinence (involuntary loss of urine and/or faeces). The causes have many different explanations, however, at least three parameters appear to influence the state: the striated musculature with its fascia and ligamentous tissue, the smooth musculature and the vascularization.
Ultrasonic scannings have demonstrated significant differences in the position of the neck of bladder in the pelvic cavity between continent and incontinent women, which means in practice that the urethral pressure for incontinent women will frequently be lower than the bladder pressure, and that the pressure transformation to the urethra, at a pressure increase in the abdomen, will be poorer and, therefore, leakage can easily occur.
It has moreover been demonstrated that when particularly the levator ani is affected, the pressure increases in the urethra, in particular mid-urethral, and the position of the neck of the bladder is moved anterior cranially toward the os pubis.
The above mentioned pressure increase in the urethra may be generated voluntarily by means of Kegel (squeezing) exercises.
The teaching of Kegel exercises, however, have involved many problems, since correct use of the deep pelvic floor musculature is difficult because of the position of the muscles. When being taught correct muscular use elsewhere in the body, one can frequently move the muscle via a joint while using so-called facilitation techniques which help the learning.
Under the law of facilitation, when an impulse has passed once through a certain set of neurons to the exclusion of others, it will tend to take the same course on a future occasion, and each time it traverses this path, the resistance in the path will be smaller. Thus, according to this principle, muscle use can be taught.
Moreover, continued Kegel exercising has the effect of increasing pelvic floor muscle bulk. In healthy women, the thickness of the hammock-shaped levator ani muscle is about 1 cm in the sagittal plane. In women having weak pelvic floor muscles and/or problems of incontinence, the muscles have become very thin in many cases.
Assessment of the strength of the pelvic floor in order to evaluate the result of the treatment also involves some problems. Influence from the pressure in the abdomen and use of synergists for the pelvic floor musculature are difficult to exclude when using e.g. various forms of biofeedback. It has been attempted to standardize vaginal palpation performed by a physiotherapist, but, naturally, a subjective measuring method has its limitations with respect to use and reproducibility.
Further, biofeedback and vaginal palpation as an examination method have been performed by most people exclusively in a supine position, which corresponds poorly with the fact that only in a standing position does the pelvic floor exhibit its functional strength and endurance.
With these problems in view, so-called vaginal weights have been used for some years as a supplement to examination as well as exercising. Good results have been obtained, and the method is easy to understand and use by the patient. However, there have been some problems in connection with the use of vaginal weights, as the anatomical conditions vaginally vary much from patient to patient, just as the anatomical conditions vary depending on the cause of the problem of incontinence.
The principle of using vaginal weights for exercising is to facilitate the muscular tissue for contraction via sensory input from the contact of the weight with the muscular tissue. This requires that the weight has a shape and a size which enable contact with the tissue. Studies have shown, however, that up to 17% of a group of women could not use common vaginal weights because the size of the levator gap made tissue contact impossible.
Measurement of endurance and strength by means of vaginal weights requires a reasonably differentiated weight distribution, and there are weights where diameter and weight “fit together”, i.e., have a certain mutual size ratio. Existing vaginal weights, however, have the drawback that the weights are dimensioned so that diameter and weight are proportional, which means that larger diameter results in greater weight. This, however, is extremely inexpedient. Physiologically, however, inverse proportionality is required because the use of the largest weight takes place in the case where the levator gap of the woman is so wide that other diameters merely slip out. Thus the problem is that a wide levator gap generally is a symptom of weak muscles, for which reason the patient cannot retain the weight.
A further drawback of certain known vaginal weights is the geometrical shape of the weight, as several of these have a conical shape at one or both ends, which may mean that the weight, after insertion and during contraction of the musculature, slides further up into the vagina and tilts so that its position becomes horizontal, and consequently is placed so high that the exercise has no effect.
A further drawback of the known vaginal weights is that, under certain conditions, they may be extremely difficult to position in the vagina, particularly if the user has a backwardly bent vagina which, in the standing position, in combination with the bend already possessed by the vagina, causes a shelf to be formed on which the weight can lie without the musculature being used.
U.S. Pat No. 5,407,412 and EP 0,392,854 both describe vaginal weights. The vaginal weights described in these documents have a conical shape at the end pointing towards the opening of the vagina. Thus the vaginal weight, after insertion and during contraction of the musculature, might slide further up into the vagina and tilt so that the position is horizontal, and consequently be disposed so high that the exercise has no effect. Another problem with the conical shape is that the vaginal weight might slide out of the vagina.
SUMMARY OF THE INVENTION
The vaginal weight in accordance with the present invention for insertion into a vagina for exercising and examining striated musculature generally includes a tubular portion with rounded end means disposed at one end of the tubular portion for enabling smooth insertion into the vagina. In combination therewith, means disposed at another end of the tubular portion are provided for enabling a user sensed vaginal resistance during outward movement of the weight from the vagina.
More particularly, in accordance with the present invention, the means disposed at another end of the tubular portion comprises a flat end surface disposed at a generally perpendicular angle with the tubular portion longitudinal axis. The flat end surface is joined with an outside surface with the tubular portion by a rounded corner.
In addition, the means disposed at another end of the tubular portion may comprise a rough surface disposed on the tubular portion outside surface.
The vaginal weight in accordance with the present invention may further include means for positioning the weight in the vagina for enhanced facilitation. This last mentioned means may be a string attached to the another end of the tubular portion.
The means for positioning the vaginal weight in accordance with the present invention may further comprise a mass disposed within the weight at a position causing a center gravity of the weight to be closer to the another end than the one end of the tubular portion.
In addition, the rough surface hereinabove noted may include an assembly of discrete optionally exchangeable embossings projecting from the tubular portion outside surface.
Further, the tubular portion may include an upper part adjacent the rounded end means and a lower part adjacent the another end with the

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