Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-20
2001-05-01
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06224580
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus, particularly for use by pregnant women, which includes a mandrel for insertion into the vagina, the main function of the apparatus being to dilate muscular, tendinous and connective tissue in the pelvic floor (diaphragma pelvis) and the perineum so as to make these tissue structures more elastic with the purpose of reducing the frequency and the size of traumatic injuries during the actual childbirth, such as breaks and ruptures, and of reducing the number of surgical interventions (episiotomy). A secondary function is that the apparatus may moreover be used for retraining a flabby pelvic floor musculature, e.g., caused by childbirth, or for ordinary maintenance training, and may thus also contribute to contraction of the above-mentioned structures.
2. The Prior Art
A single apparatus of this type is known, viz. from EP 0 574 966 B1. T his apparatus, which has a purely mechanical action, includes a distendible mandrel for insertion into the vagina. The mandrel includes a plurality of elements which may be displaced radially from each other by means of a wedge effect or linkage in order to expand the pelvic floor. The apparatus has a relatively heavy and clumsy appearance, but provides excellent control when training expansion of the pelvic floor, e.g., for an imminent birth. The apparatus can give a measure of the expansion of the pelvic floor from time to time and protects against an unintentional too rapid expansion that may cause damage to the pelvic floor, as the user herself controls the expansion. The excellencies of the apparatus, however, are overshadowed by the circumstance that the apparatus is not very handy and convenient in use. Thus, the apparatus has the undesirable property that, when operated, it can rotate in the vagina.
The object of the invention is to provide an apparatus of the above-mentioned type which is easier to use than the purely mechanically acting apparatus mentioned above.
SUMMARY OF THE INVENTION
This object is achieved according to the invention by an apparatus which is characterized in that the mandrel has mounted thereon an expandable length of hose which may be connected with an air pump or the like for the fluid through at least one channel in the mandrel, and that the mandrel has a vent channel extending longitudinally through it and terminating outside the user in use. The use of a length of hose provides for an expansion in the transverse direction alone, while allowing a vent channel to be provided. Insertion of this apparatus into the vagina is easier than the purely mechanical one, as the apparatus according to the invention may basically be made smaller, i.e., primarily thinner. Furthermore, the apparatus does not tend to rotate in operation and use.
It will be appreciated that the apparatus according to the invention differs from the type of devices comprising a balloon, which are exclusively used for measuring the muscular strength of the pelvic floor and retraining it, cf. e.g., U.S. Pat. No. 4,050,499 which discusses Kegel's Perineometer among other things. The apparatus also differs from dilators as described in DE 38 03 727 C1 in which a mandrel is coated by a closed envelope which leaves no possibility of an evacuation channel.
The invention also relates to a protective cover for the apparatus according to the invention. The cover is formed by a length of hose intended to be applied to mandrels and at least secured at or near one end. The protective cover, which is discarded after each use of the apparatus, serves a hygienic purpose as well as a safety purpose in the event that the dilated length of hose should break.
The use of a liquid as the fluid readily provides a measure for the expansion like in the mechanical apparatus. The situation is different when using a gas, typically atmospheric air, as the fluid since this is compressible. To prevent expansion altogether beyond the permissible amount, a restrictive envelope, e.g., in the form of a net, may be inserted over the length of hose, which net may optionally be integrated in the length of hose. Alternatively, the cover may be shaped so as to have a restrictive effect, and graduation of the maximum size allowed for the covers and coding, e.g., by colour, may provide a measure of the expansion achieved for each use. This may be combined with an adjustable pressure relief valve in the apparatus which sets an upper limit to how hard the length of hose may be inflated.
For the secondary function of the apparatus, i.e., retraining of a flabby pelvic floor musculature, the mandrel may be provided with a casing which is applied over the front of the mandrel and which protrudes somewhat across the expandable length of hose, so that said length is active only on the rearmost part, i.e., precisely the part with which the pelvic floor musculature is retrained.
The invention will be described more fully below with reference to the example illustrated in the accompanying drawing. In the drawings:
REFERENCES:
patent: 899477 (1908-09-01), Williams
patent: 923303 (1909-06-01), Shults
patent: 2026747 (1936-01-01), Nemzek
patent: 3799170 (1974-03-01), Walsh et al.
patent: 4198981 (1980-04-01), Sinnreich
patent: 4664114 (1987-05-01), Ghodsoan
patent: 5338297 (1994-08-01), Kocur et al.
patent: 3803727 (1989-04-01), None
patent: 3800744 (1989-05-01), None
patent: 2297036 (1996-07-01), None
patent: 2071285 (1997-01-01), None
Dykema Gossett PLLC
Mendez Manuel
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