An apparatus for treatment of the female pelvic floor The present invention relates to an apparatus, particu- larly for use by pregnant women, and comprising a mandrel for insertion into the vagina, the main function of said apparatus being to dilate muscular, tendinous and connec- tive 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 child- birth, such as breaks and ruptures, and of reducing the number of surgical interventions (episiotomy). A secon- dary 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 train- ing, and may thus also contribute to contraction of the above-mentioned structures.

A single apparatus of this type is known, viz. from EP 0 574 966 B1. This apparatus, which has a purely mechanical action, comprises a distendible mandrel for insertion into the vagina. The mandrel comprises 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 pro- tects 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 appara- tus, 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.

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 va- gina is easier than the purely mechanical one, as the ap- paratus according to the invention may basically be made smaller, i. e. primarily thinner. Furthermore, the appara- tus 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. US 4 050 499 which discusses Kegel's Perineome- ter among other things. The apparatus also differs from dilators as described in DE 38 03 727 Cl in which a man- drel is coated by a closed envelope which leaves no pos- sibility 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 appara- tus, serves a hygienic purpose as well as a safety pur-

pose in the event that the dilated length of hose should break.

The use of a liquid as the fluid readily provides a meas- ure 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. Al- ternatively, the cover may be shaped so as to have a re- strictive effect, and graduation of the maximum size al- lowed for the covers and coding, e. g. by colour, may pro- vide 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. re- training of a flabby pelvic floor musculature, the man- drel 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 re- trained.

The invention will be described more fully below with reference to the example illustrated in the accompanying drawing. In the drawing: fig. 1 shows an embodiment of the apparatus according to the invention, seen from the side,

fig. 2 shows a longitudinal section of the apparatus of fig. 1, fig. 3 shows the apparatus of fig. 1 in a dilated state and provided with a protective cover, fig. 4 shows the apparatus of fig. 1 where the air pump is connected with the apparatus by a hose, fig. 5 shows a longitudinal section through a variation of the apparatus shown in figs. 1-4, fig. 6 shows a longitudinal section through a variation of the apparatus shown in fig. 5, fig. 7 shows a second embodiment of the apparatus accord- ing to the invention, seen from the side, fig. 8 shows a longitudinal section through the apparatus of fig. 7 in an inflated state, fig. 9 shows a longitudinal section through the apparatus with an alternative embodiment of the air pump, fig. 10 shows a lateral view of a further embodiment of the apparatus according to the invention, fig. 11 shows a perspective view of the apparatus shown in a disassembled state, fig. 12 shows a longitudinal section through the appara- tus as shown in fig. 10, fig. 13 shows an exploded view of the apparatus,

fig. 14 shows a perspective view of the apparatus to- gether with a cover for application to its mandrel, fig. 15 shows the same as fig. 14, but seen from the other end of the apparatus, fig. 16 shows a perspective view of the apparatus with partially applied cover, and fig. 17 shows a perspective view of the partially applied cover.

The apparatus shown in fig. 1 comprises an intermediate member 1 whose rear end is connected with an air pump 2 in the form of a rubber ball, and which forwardly merges into a mandrel 3 around which a length of hose 4 is se- cured, said length being inflatable by means of the hand pump.

As will appear from fig. 2, a through-going pressure equalization channel is provided in the mandrel 3 and the intermediate member 1, said channel extending from the tip of the mandrel and out on the underside of the inter- mediate member. The intermediate member has an air chan- nel 6 which connects the air pump 2 with the inner side of the length of hose 4 via a duct in the mandrel shown in dashed line and having distribution channels (not shown) which terminate on the upper side of the mandrel.

The shape of the mandrel is adapted to the vagina, and the apparatus as a whole is shaped for easy insertion into it. The intermediate member has a ring-shaped expan- sion 7 which indicates the maximum insertion of the man- drel into the vagina. During insertion, air in the abdo- men will be evacuated through the air equalization chan- nel 5. When the apparatus is in position, the length of

hose 4 is inflated to the desired firmness. If the length of hose breaks by accident, the air escaping into the ab- domen will likewise be evacuated through the pressure equalization channel 5.

After completed use the apparatus may be vented by de- flating the length of hose by means of a valve 8 in the air channel 6 of the intermediate member which communi- cates with a branch 9 to the underside of the intermedi- ate member. A manometer may be connected with the branch, allowing a picture of the muscular strength in the area to be obtained by the pressure.

For reasons of hygiene and safety, the mandrel may be provided with a replaceable cover 10 in the form of a length of hose prior to each exercise, see fig. 3 which shows the apparatus in its state of maximum dilation. One end of the cover 10 is passed into the pressure equaliza- tion channel 5, and its other end is rolled down over the mandrel. To facilitate the application, the end of the cover intended to be inserted into the channel 5 may be given a tubular shape or be provided as a decided tube which fits here. The application of the cover is carried out before the apparatus is inflated. An elastic ring 11 is arranged at the outer end of the cover, and this ring is moved across the elevation 7 and down in front of it.

There is still a passageway through the pressure equali- zation channel 5 for pressure equalization during inser- tion and for discharge of the air in the event that the length of hose 4 should become leaky. In that respect the cover has the additional advantage that it prevents the air from penetrating into the abdomen, but conveys it ei- ther directly into the air channel or allows the air to escape below the cover 10 at the attachment 11 to the in- termediate member.

Apart from the aspect of hygiene, the cover 10 also turns out to have a stabilizing effect on the length of hose 4.

It has been found that in some cases the length of hose is not inflated uniformly around the mandrel. The phe- nomenon may possibly be ascribed to the circumstance that the latex is produced with a relatively great inaccuracy in thickness. The cover has been found to have an align- ing effect on the inflated length of hose, i. e. it will be positioned symmetrically or essentially symmetrically with respect to the mandrel.

A latex of a thickness in the range of 0.8-1.4 mm is used for the length of hose. A thinner latex makes the length of hose too unstable, while a thicker latex is too stiff.

For the users who find it inconvenient to operate the ap- paratus with the air pump mounted directly on the end of the intermediate member, the air pump may be removed and connected with a hose 12 of a suitable length, as shown in fig. 4.

The apparatus is handy and easy to operate in contrast to the previous purely mechanical solution, just as the hy- giene and safety in use are great.

Referring to fig. 2 again, it is noted that the interme- diate member 1 has a polygonal, e. g. hexagonal, stem- shaped extension 13 which forms the inner part of the mandrel, while the outer part 14 is pushed inwardly thereover. The length of hose 4 is secured in that it is fixed with the ends between the part 14 and the breast 15 of the intermediate member 1 and a dome-shaped nut 16 which is screwed on to a threaded member that terminates the hexagonal stem. A washer 17 is arranged between the nut 16 and the part 14.

A variation of the above-mentioned embodiment is shown in fig. 5 of the drawing in which the intermediate member 1 and the mandrel 3 are made in one piece. For attachment of the length of hose 4, an annular groove 18 is provided at the end of the mandrel toward the intermediate member to receive the end of the length of hose. For retention of it, the elevation is shaped as a detachable locking ring 19 which may be pushed inwardly over the intermedi- ate member, and which is locked in the groove 18 by a snap lock connection. The other end of the length of hose 4 is secured by means of the nut 16, which may alterna- tively be provided as a ring-shaped button which may be clicked on to the end of the mandrel by a snap lock con- nection, said mandrel being in that case formed with the corresponding locking parts instead of threads. Instead of incorporating the vent valve in the intermediate mem- ber, an air pump 2 having an integrated vent valve may be used.

If the end of the mandrel is allowed to be uncovered, one end of the cover 10 may be secured by the nut 16, while the other end is correspondingly secured on the outer side of the locking ring 19. To facilitate the discharge of air below the elastic ring of the cover in the event that the length of hose 4 should be leaky, the locking ring 19 is provided with grooves 20.

To make the apparatus, which is made of plastics, lighter, the mandrel 3, as shown in fig. 6, may be formed with ribs 21, thereby reducing the required amount of ma- terial. The ribs 21 are covered by the length of hose 4 so that the user will perceive the apparatus as being an essentially smooth mandrel. In contrast to the previously shown embodiments, the pressure equalization channel 5 is curved here, thereby allowing the intermediate member 1 to be made less curved than when the air channel is rec-

tilinear. The latter requires a relatively great radius of curvature of the intermediate member for the air chan- nel to terminate on the underside thereof. Here too, the vent channel 8 is part of the air pump, and the air chan- nel 6 here terminates in the space to the first rib. In the embodiment shown, the locking ring 19 is composed of two halves which may be locked mutually around the appa- ratus by a snap lock connection. The end 16 of the man- drel is here shaped as a ring-shaped button which is snapped on to the mandrel.

Still another embodiment of the apparatus of the inven- tion is shown in figs. 7 and 8 of the drawing. Like be- fore, the main components of the apparatus are an air pump 2, an intermediate member 1 and a mandrel 3. The air pump, which is not shown in detail in the drawing, is op- erated by a push button 22 at the end. The air pump and the intermediate member are applied as an integrated unit to the end of the mandrel by a snap lock connection. The length of hose 4 is retained with rings 23 at the ends in grooves in the mandrel. There is communication from the pump with the air channel 6 which, with transverse chan- nels, extends out on the side of the mandrel. The central air channel 5 communicates with the outer side of the ap- paratus through openings 24 in the intermediate member 1.

The protective cover 10 is attached at the free end of the mandrel by the ring 23 which secures the length of hose, and the other end is secured by the elastic ring 11 in a groove in the mandrel and is secured in the connec- tion of the pump/intermediate member with the mandrel. In case of leakage in the length of hose, the air escapes through channels (not shown) which communicate with a groove 25 at the end of the mandrel. The air is dis- charged to the surroundings via the openings 24.

A special embodiment of the air pump 2 is shown in fig.

9, said pump accommodating a rod 26 having a through channel 27 at whose free end a non-return valve 28 is ar- ranged. The rod is connected with a valve mechanism 28 in the intermediate member 1. Inflation of the length of hose takes place by squeezing the pump ball, as described in connection with figs. 1-6, there being an air passage in the rod from the channel therein to the interior of the ball. Venting of the apparatus takes place by press- ing the end of the rod 26 inwards toward the intermediate member 1, whereby the valve mechanism 28 opens to allow air to flow out into a gap 29 between the air ball and the intermediate member 1.

Figs. 10-13 of the drawing show a further embodiment of the apparatus according to the invention, in which the same components are designated by the same reference nu- merals as in the foregoing. Here, the mandrel 4 is com- posed of an outer pipe 21 having a collar 23 at each end around which the length of hose 4 is secured with the ends, which are shaped so as to enter into the tubular shape of the length of hose, i. e. the ends of the length of hose are rolled over the collars of the outer pipe.

The mandrel is assembled with an inner pipe 34 having a threaded portion 35 at one end and a flange 36 at the other end. During assembly, the inner pipe 34 is moved into the outer pipe 31 which has been coated with the length of hose 4 beforehand. The inner pipe is moved fur- ther on through a hole, intended for the purpose, at the end of the intermediate member 1, which is here shaped as a bowl-shaped jacket. Before the bottom of this, an in- sert 37 having a central hole for the inner pipe is ar- ranged. The free end of the insert 37 is formed with a recess 38 to receive a washer 39 as well as a nut 40, which may be screwed on to the end of the inner pipe 34 for clamping the apparatus. As a result of the clamping,

the outer end of the length of hose 4 is secured between the collar 32 of the outer pipe and the flange 36 of the inner pipe, while the inner end is fastened between the collar 32 of the outer pipe and the bottom of the inter- mediate member 1, which is here formed with a recess 41 corresponding to the collar 32.

In the assembled state, there is a ring-shaped cavity 42 between the inner and outer pipes 31,34, as the inner pipe, at each end, has an internal flange 43 which en- gages the outer side of the inner pipe. Centrally on the outer pipe there are holes for the air out to the chamber below the length of hose 4.

The insert 37 has an air channel 46 therein which termi- nates in a hose connector 47 on the free end face of the insert and terminates in a ring-shaped recess 48 at the other end toward the mandrel, from which the air can pass on through openings in the adjoining flange 43 of the outer pipe and further on to the cavity 45.

The free end of the intermediate member 1 is shaped as a large opening in which a correspondingly shaped air pump 2 may be arranged. The end of the air pump is formed with a constriction 49 which may be a press fit in one end of the intermediate member. The inner end face of the air pump has a pressure relief valve 50 which prevents the length of hose from being inflated too hard. Further, there is a hose connection 51 for connecting the pump with the rest of the apparatus by a hose 52. The interme- diate member is constructed such that the hose may be stored in its coiled state in the cavity thereof when the apparatus is not in use. An inlet valve 28 is provided at the outer end of the air pump, and this valve can also serve as a vent valve when the air is to be released from the apparatus after completed use.

Figs. 14-17 of the drawing show an embodiment of the cover 53 intended for application on the mandrel 3 of the apparatus. The cover comprises a pipe 54 which is rela- tively stiff and which can be passed into the vent chan- nel 15 of the apparatus. The pipe has a length such that it extends in the entire or substantially the entire length of the inner pipe, as indicated in fig. 16. At one end the pipe merges into the cover part 55 itself, which is in a coiled state. The cover is applied by passing the pipe 54 into the vent channel of the apparatus until the coiled cover part 55 meets the end of the apparatus. The cover part 55 is then rolled inwardly over the mandrel and upwardly over the intermediate member 1 and extends across the opening with a terminating elastic ring. The cover is rolled off and discarded after completed use of the apparatus.

This embodiment of the apparatus is very convenient for the user as the air pump can readily be separated from the apparatus and be held in a convenient position, while the cover adds to the hygiene of the apparatus.