The present invention relates to an incontinence device particularly adapted for the use of female 5. patients.

The problem of incontinence in women has long been difficult to solve. In hospitals the use of a self-retaining catheter inserted into the urethra is normal practice, and while this successfully

10. controls involuntary flow it brings with it the problem of infection. In addition, professional help is normally required in replacing the catheter, which makes it inconvenient for use when the patient is not in hospital. The use of known incontinence

15. clothing has little more than an external cosmetic effect, and since urine flow is not prevented the patient remains continually wet and uncomfortable.

Incontinence in females may be a transient condition or a long term condition or an involuntary

20. condition.

The present invention has a number of aspects which address these different conditions but all the aspects have in common the characteristic of an internal portion which is held in or urged into

25. functional cooperation with the urethra by secure- ent of an external portion to tensioning means secured to, or mounted on the users body externally or the users clothing.

Moreover, the present invention in its various aspects consists essentially of a simple moulded device which can be worn in the vagina, and which is easy to use in that it can easily be inserted and

5. removed by the patient herself and worn, when required, at home. It may conveniently be moulded in a one-piece form which is cheap to manufacture and easy to clean or cheap enough to be disposable. The condition referred to above as transient may

10. be when the incontinence has been caused by trauma such as an operation and the patient can be expected gradually to regain control of bladder function. Here a drainage version of the device in accordance with the invention may be most appropriate, since

15. it will accommodate inadvertant bladder leakage but enable the user to observe her increasing degree of control and gain confidence therefrom.

This form of device is also useful where the patient has long term incontinence and for example

20. is bed ridden.

The condition referred to as long term may on the other hand require more complete control as indeed may the transient condition when the patient has left hospital. Here a restrictive version of

25. the invention is used in which the internal portion of the device occludes the urethra so that the device is removed to discharge the bladder.

Hybrids of these two versions are also envisaged in which a drainage channel is provided in the 30. device, but this is occludable either by operation

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of an external control device or has an occlusion which can be overcome internally by the user exerting muscular force to express urine from the bladder past the occlusion. The former arrangement is preferred. 5. The condition referred to above as involuntary is a further condition of female incontinence which is known as stress incontinence. This is a condition in which involuntary discharge of urine occurs only in certain circumstances such as when 10* the person coughs or jumps. This is caused by the bladder dropping. Known techniques which have been applied to try to control this condition comprise the so-called watch spring pessary and a surgical procedure in which a ligature is placed round the 15. urethra. Both techniques aim to relocate the urethra in the normal position. The former tech¬ nique is not very effective, the device tending to slip from the correct position and the latter technique involves a surgical procedure. 20. The third version of the present invention addresses the problem of stress incontinence. Here the internal portion of the device in accordance with the present invention functions to relocate the urethra but is urged into the correct position by 25. the external securement and tensioning of the device. Thus according to the broadest aspect of the present invention an incontinence device for use by females is provided with an internal portion gener¬ ally shaped so as, in use, to conform to or contact

30 the anterior vaginal wall of the user and an external

portion arranged, in use, to extend out of the vaginal opening, the device being provided with tensioning means, external to the user in use of the device, the tensioning means being adapted to be

5. secured to or mounted on the users body externally, or to or on the users clothing, and optionally securing means for securing or mounting the tensioning means to or on the users body externally, or to or on the users clothing, the arrangement

10. being such that in use the internal portion is located in the vagina conforming to or contacting the anterior vaginal wall and the tensioning means is secured to or mounted on the users body externally or to or on the users clothing whereby

15. the internal portion of the device is urged into or held ^" in functional cooperation with the urethra. According to one aspect of the invention, which has been referred to above as the drainage version, an incontinence device for use by females is pro-

20. vided with an internal portion generally shaped so as, in use, to conform to or contact the anterior vaginal wall of the user and an external portion arranged, in use, to extend out of the vaginal opening, the device being provided with tensioning

25. means, external to the user in use of the device, the tensioning means being adapted to be secured to or mounted on the users body externally or to or on the users clothing, and optionally securing means for securing or mounting the tensioning means to or

30. on the users body externally or to or on the users

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clothing, the arrangement being such that in use the internal portion is located in the vagina conforming to or contacting the anterior vaginal wall and the tensioning means is secured to or mounted on the

5. users body externally or to or on the users clothing whereby the internal portion of the device is urged into or held in functional cooperation with the urethra, the device being arranged, in use, to fit around the opening to the urethra and provided with

10, duct means to permit discharge of urine from the urethra through the device.

The duct means are preferably such as in use to extend from the opening of the urethra to outside the vaginal opening.

15. This form of the device is generally shaped so as to conform with the anterior vaginal wall and to extend out of the vaginal opening, preferably forward therefrom and particularly desirably generally to conform to the outer part of the body 0, directly forward of the vaginal opening, and being provided with means to channel the urine into an external receptacle. It preferably consists of two limbs which together form a generally U or V-shaped configuration, a first or upper limb being provided 5 with a medially extending channel on its inner face which communicates with an internal duct in a second or lower limb, which duct extends through the second limb to emerge at its outer face at or near its end, and continues as or is attached to a tube. This 0, tube conveys the urine to a suitable receptacle,

which may be attached to the patient's leg.

This version of the invention retains one of the advantages of the catheter in that the urine can still be observed and its volume measured for

5. diagnostic purposes.

In another aspect of the invention, which has been referred to above as the restrictive version, an incontinence device for use by females is pro¬ vided with an internal portion generally shaped so

10. as, in use, to conform to or contact the anterior vaginal wall of the user and an external portion arranged, in use, to extend out of the vaginal opening, the device being provided with tensioning means, external to the user in use of the device,

15. the tensioning means being adapted to be secured to or mounted on the users body externally, or to or on the users clothing, and optionally securing means for securing or mounting the tensioning means to or on the users body externally, or to or on the users

20. clothing, the arrangement being such that in use the internal portion is located in the vagina conforming to or contacting the anterior vaginal wall and the tensioning means is secured to or mounted on the users body externally or to or on the users clothing

25. whereby the internal portion of the device is urged into or held in functional cooperation with the urethra, the device being provided with occlusion means arranged in use to occlude the urethra and thus prevent discharge of urine from the bladder.

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In this aspect of the invention the device is shaped so as to contact the anterior vaginal wall and to extend out of the vaginal opening, preferably forward therefrom, and particularly desirably

5. generally to conform to the outer part of the body directly forward of the vaginal opening, and being particularly shaped so as to be adapted to cause occlusion of the urethra on being urged against the anterior vaginal wall above the urethral opening.

10. It preferably consists of two limbs which together form a generally U or V shaped configuration, the urethral occlusion being caused by the pressure of the first or upper limb on the vaginal wall. The occlusion means may comprise a protuberance which

15. presses against the urethra.

In one form of this aspect of the invention the protuberance is compressible and is such that it will prevent involuntary discharge of urine but permit voluntary discharge brought about by muscular

20. activity of the user.

In another form of this aspect of the invention the protuberance can be increased in size or reduced in size by control means located externally in use. The protuberance may comprise a fluid filled

25. bag, e.g. a liquid or gas, e.g. air, filled bag, connected to pump means which in use are located externally.

According to a further aspect of the present invention, the stress incontinence version, an

30. incontinence device for use by females is provided

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with an internal portion generally shaped so as, in use, to conform to or contact the anterior vaginal wall of the user and an external portion arranged, in use, to extend out of the vaginal opening, the

5. device being provided with tensioning means, external to the user in use of the device, the tensioning means being adapted to be secured to or mounted on the users body externally, or to or on the users clothing, and optionally securing means

10. for securing or mounting the tensioning means to or on the users body externally, or to or on the users clothing, the arrangement being such that in use the internal portion is located in the vagina conforming to or contacting the anterior vaginal wall and the

15. tensioning means is secured to or mounted on the users body externally or to or on the users clothing whereby the internal portion of the device is urged into or held in functional cooperation with the urethra, the interior portion being arranged in use

20. to hold the users urethra in a normal or approxi¬ mately normal position whereby stress incontinence is substantially alleviated or eliminated.

Preferably in this aspect of the invention the interior portion has an opening so that in use the

25. opening of the urethra is not occluded.

As mentioned above the invention also extends to hybrid versions, e.g. of the drainage and restrictive versions of the invention.

The invention in a further aspect thus extends

30. to an incontinence device for use by females which

is provided with an internal portion generally shaped so as, in use, to conform to or contact the anterior vaginal wall of the user and an external portion arranged, in use, to extend out of the 5. vaginal opening, the device being provided with tensioning means, external to the user in use of the device, the tensioning means being adapted to be secured to or mounted on the users body externally, or to or on the users clothing, and optionally

10. securing means for securing or mounting the tensioning means to or on the users body externally, or to or on the users clothing, the arrangement being such that in use the internal portion is located in the vagina conforming to or contacting

15. the anterior vaginal wall and the tensioning means is secured to or mounted on the users body externally or to or on the users clothing whereby the internal portion of the device is urged into or held in functional cooperation with the urethra,

20. the device being arranged, in use, to fit around the opening to the urethra and provided with duct means to permit discharge of urine from the urethra through the device, and the device also being provided with occlusion means arranged in use to controllably or

25. overcomably occlude the urethra so as to permit the user at will to permit or cause discharge of urine from the bladder.

An incontinence device in accordance with the present invention may consist of two limbs which together form a generally U or V-shaped configura¬ tion, a first or upper limb affording the internal

5. portion of the device and a second or lower limb affording the external portion of the device and to which is attached the tensioning means.

The first limb may be shorter than the second limb, or they may be of essentially equal length,

10. but this is not essential, the upper limb may be significantly shorter provided the necessary seal can be maintained. On the other hand an arrangement in which the lower or outer limit is shorter is not excluded.

15. In those forms of the incontinence device which are provided with occlusion means, these may be provided on the upper limb by a forwardly facing protuberance, the pressure of which on the vaginal wall causes or assists the urethral occlusion.

20. The device may also be held in position by a rearwardly-extending portion which is pressed against the dorsal vaginal wall.

This rearwardly - extending portion may be either a rigid loop attached to the upper limb,

25. or a moulded extension to the base of the U, or preferably may be generally shaped so as to conform to the lower vaginal wall proximate to the vaginal opening. In this case, the device is preferably provided with a second duct to allow egress of

30. natural vaginal fluids.

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In another form of the invention a rearwardly extending portion extends from the region of the upper end of the interior portion and across the vagina laterally and extends into the region of the 5. cervix or past it but stops short of the dorsallwall of the vagina. This assists in maintaining the device in the laterally correct position and is particularly useful in the stress incontinence version of the invention. 10. The device may be made of a rigid or semi-rigid substance and is preferably provided with soft pads or coverings for comfort.

The tensioning means may conveniently comprise a strap or cord attached at one end to a belt, the 15. tension being due to the elasticity of the cord or that of the belt, or both, the belt also constituting the securing means.

It may be desirable, for comfort, for the strap to be of a soft or padded material or for it to be 20. sheathed.

In another form of the invention the device is generally rigid but is provided with a flexible portion between the limbs allowing hinging motion therebetween. 25. In order to produce or assist in producing a fluid-tight seal between the anterior vaginal wall and the inner face of the first limb, a suitable substance of putty-like consistency may be used. The invention may be put into practice in 30. various ways, and a number of specific embodiments

will be described by way of example with reference to the accompanying drawings, in which:

Figure 1A is a perspective view of a first embodiment of the invention showing a drainage 5. version of the invention;

Figure IB is a front elevation of the device shown in Figure 1A;

Figure 2 is a medial cross section of the embodiment of Figures 1A and IB illustrating the 10. drainage channel and tube outlet;

Figure 3A is a medial cross section of the lower part of the female body, showing the embodiment of Figure 1 in position, in which position it is held either by an external strap (chained line) or by the 15. external strap and an internal loop (dashed line);

Figure 3B is a view similar to Figure 3A showing a first modification of the first embodiment, provided with sheathing of the strap and a modified internal positioning arrangement. 20. Figure 4 illustrates one method of securing the embodiments of the invention in position, in which an extensible strap and belt are used;

Figure 5 is a perspective view of a second modification of the first embodiment of the 25. invention, in which the device is shaped to conform to the vaginal opening as well as being held in place by a strap and belt;

Figure 6A is a medial cross section of this second modification of the first embodiment, 30. illustrating the drainage channel and tube and showing a second conduit which allows egress of the natural vaginal fluids;

Figure 6B is a transverse cross-section of the arrangement shown in Figure 5 taken on the line VIB-VIB;

Figure 7 is a perspective view of the second

5. embodiment of the invention showing a restrictive version of the invention;

Figure 8 is a medial cross section of the lower part of the female body showing the embodiment of Figure 7 in position, in which position it is held

10, either by an external strap (see Figure 4) (chained line) or in a first modification of this second embodiment by the external strap and by an internal loop (dashed line);

Figure 9 is a perspective view of a second

15. modification of this second embodiment of the invention, in which the device is shaped to conform to the vaginal opening as well as being held in place by a strap and belt (as in Figure 4) ;

Figure 10 is a medial cross section of the

20 second modification of the second embodiment (shown in Figure 9) illustrating a conduit which allows egress of the natural vaginal fluid;

Figure 11 is a plan view from the front of a third modification of the second embodiment;

25, Figure 12 is a medial cross section of this third modification of the second embodiment;

Figure 13 is a plan view from the rear of the embodiment shown in Figures 11 and 12;

Figure 14 is a cross section similar to Figure

30. 8 showing the third modification of the second embodiment in use;

Figure 15 is a perspective view from one side

and behind of a fourth modification of the second embodiment of the invention in which an overcomable occlusion means is provided, the general shape of the device being similar to the third modification

5. of the second embodiment;

Figure 16 is a cross section on the line XVI-XVI of Figure 15;

Figure 17 is a side elevation of a fifth modification of the second embodiment of the

10. invention in which a controllable occlusion means is provided, the device otherwise being similar to that shown in Figure 15;

Figure 18 is a cross section on the line XVIII-XVIII of Figure 17 showing in full lines the

15. open position of the occlusion means and in dotted lines the closed position;

Figure 19 is a perspective view from one side and behind of a first form of the third embodiment, the stress incontinence version, of the invention;

20. and

Figure 20 is a similar view to Figure 19 of a second form or first modification of the third embodiment of the invention which is provided with a dorsal extension similar to that shown in Figure 3B.

25. The differences between Figures 3A, 3B and 8 on the one hand and Figure 14 on the other hand reflects the wide range of different shapes and sizesof the vaginal cavity, which in fact really only exists as a cavity when a member is inserted

30. into it. The most constant feature is the location of the anterior dorsal vaginal wall and its rela¬ tionship to the pubic bone, (25 in Figure 3B) . However, even the shape of the pubic bone can vary widely.

In the first embodiment the invention takes the form shown in Figure 1, and consists of two inte¬ grally connected limbs 1 and 2, the inner or upper limb 1 broadening out into a tongue or in elevation 5. (see Figure IB) light bulb shaped plan, and the outer of lower limb 2 being narrower and not broadening out at its end. The limbs 1 and 2 together provide a generally U or V-shaped config¬ uration, the inner face 3 of the lower limb of the U ₁ 0. being generally flat or concave. The inner face 4 of the upper limb 1 affords a centrally disposed medially extending duct, channel, or groove 5 defined by the edges of the limb 1, which edges are slightly rounded at its far end 6. 15. The edges 4 of the channel 5 may also be rounded along its length. The channel issues out of the end 6 of the limb 1 and extends around the base of the U some distance (e.g. about 20 to 30% e.g. 25% of the length) along the lower limb 2, where it terminates 20. on the surface of the limb 2 in a rounded end 7.

The channel 5 communicates with an internal duct 8, at or near its end 7, which duct extends more or less diagonally through the limb 2 to emerge through its outer face at 9, at or near the end of the limb 25. 2. This angle enables the bladder to be emptied even when the woman is sitting down. The duct 8 is there connected to, or continues as a tube 10. In use, the limb 1 of the device is inserted into the entrance of the vagina, and is positioned so as to 30. be located in the vagina as shown in Figure 3A, with the limb 1 being placed against the anterior vaginal wall 11 the channel 5 being positioned so as to follow the course of the urethra 12. It is not

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essential for the limb 1 to extend as far into the vagina as shown in Figure 3A. It may be shorter, provided an adequate seal can be maintained between the vaginal wall 11 and the edges 4 of the channel

5. 5. The lower limb 2 points forwardly and is positioned against the outer surface of the body, within the vulva 13. The urethral opening 14 is thus positioned within the channel 5. Any urine escaping from the urethral opening 14 will pass along the

10. channel 5, through the duct 8 and pass into the tube 10 where it may be collected by any suitable means such as a receptacle attached to the patient's leg.

The device is held in position by means of external tensioning means one form of which is a

15. strap 15 which is attached to or is a continuation of the second limb 2 from its forward end 16. The strap 15 (which may be padded or sheathed for com¬ fort) may conveniently be attached to a belt 17 as shown in Figure 4 and is maintained in tension by

20. its own elasticity or that of the belt 17, or both. When the strap 15 is sheathed this is conveniently achieved by a plastics tube 16A which may extend (as shown in Figure 3B) from the end of limb 2 (to which it may be connected) out beyond the vulva 13, e.g.

25. s far as 16B (see Figure 3B) . This prevents the tensioning means rubbing the user. The means 15 may only be elastic within such a tube and thereafter be connected to the belt by an inelastic connection. The belt may be elastic or inelastic. This tension

30 , causes the limb 1 to be pressed against the anterior vaginal wall 11. The necessary seal between the

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vaginal wall 11 and the edges 4 of the channel 5 may be enhanced by lining the edges 4 with any suitable material such as a soft pad, or a cohesive gum of suitable consistency may be used. Suitable gums 5. include a mixture of Karaya gum, glycerine and gelatine mixed to a putty-like consistency, or alternatively liquid polymers such as a cellulose- polybutene combination may be used.

Figure 3B shows a further modification in which 10. a dorsal extension 1A of generally duck bill shape extends rearwardly from the top back face of the limb 1 towards or past the cervix, but stops short of the dorsal wall of the vagina and extends across this region of the vagina. A dorsal extension of 15. this sort is also shown and described in Figure 20 (see reference 207). This extension helps maintain accurate lateral location of the device in use. In a first modification of the device, the necessary support may be increased internally 20. particularly against lateral movement. This may take the form of a generally rigid but resilient loop 18, which is attached to the back or outer face of the limb 1 as shown in Figures 1 and 3A by dashed lines. In this modification the belt and strap 25. again hold the device in place and cause the limb 1 to be pressed against the anterior vaginal wall 11 in the position previously described. The loop 18 being pressed against the upper dorsal vaginal wall 19 behind the cervix 20 with the natural elasticity 30. of the vaginal wall 19 helps to hold the device in place particularly against lateral movement.

In a second modification of this first embodiment, shown in Figure 5 and in cross section in Figure 6, the device is shaped so as to be held in place between the anterior and dorsal vaginal

5- walls, 11, 21 in the vaginal entrance as well as being held in place by the belt and strap. The limbs 1,2 are generally as described above for the first embodiment, but the base of the U is extended to form a generally saddle-shaped protrusion 22,

10. moulded to conform to the general shape of the lower dorsal vaginal wall 21 and provided on either side and its lower edge by outwardly and downardly extending wings 22B and 22C which in use bear against the users external body surface outside the

15. vagina.. In use, the device is held in position by the combined pressure of the anterior wall 11 on the upper limb 1 and that of the dorsal wall 21 on the saddle-shaped protrusion 22 as well as the belt and strap. The protrusion 22 is provided with a

20. generally vertically disposed duct 23 extending between its upper and lower surfaces, which duct serves to allow egress of natural vaginal fluids, and to permit easy removal of the device.

In a third modification the end of the channel 5

25. i _s left open rather than communicating with the duct 8 and tube 10 (which are then no longer needed and can be omitted) . This arrangement may thus be similar to the opening 205 described below for Figures 19 and 20.

30 The device may be made of any suitably flexible material such as rubber, or it may be made of a more rigid material such as polypropylene and provided with pads of compressible material for comfort, in

the necessary regions. The structure should be sufficiently rigid to ensure secure location in the vagina and to enable the force exerted by the strap 15 to pull the limb 1 against the vaginal wall 11. 5. If the device is made of a generally rigid material, the base of the U, between the limbs 1 and 2, may be made of a more flexible material to allow some hing¬ ing movement between the limbs, thus accommodating personal differences in vaginal shape. When the loop 10. 18 is present the hinging embodiment can be used or the device can be made of more flexible material throughout. The use of a non-reactive material may be useful to patients with allergies to rubber or silicone products. 15. This first version, the drainage version, of the invention deals with incontinence by collecting the urine.

The second version, the restrictive version, of the invention mechanically causes retention of the 20. urine.

In the second embodiment, this restrictive version of the invention takes the form shown in Figure 7 and consists of two integrally connected limbs 101,102. The limbs 101 and 102 together 25. provide a generally U or V-shaped configuration, the inner face 103 of the lower limb 102 being generally flat or concave. The inner face 104 of the upper limb is generally flat or convex and terminates in an inwardly-facing protuberance 105, of which the 30. edges are rounded as shown in Figure 7. In use, the limb 101 of the device is inserted into the entrance to the vagina, and is positioned so as to be located in the vagina as shown in Figure 8 with the limb 101

being placed against the anterior vaginal wall 11, following the line of the urethra 12.

The lower limb 102 points forwardly and is positioned against the outer surface of the body

5. within the vulva 13. The device is held in position by means of tensioning means, one form of which is a strap 115 which is attached to or is a continuation of the lower limb 102 at its forward end 116. The strap 115 (which may be padded for

10. comfort or sheathed as described above in connection with Figure 3B) may conveniently be attached to a belt 17 (as shown in Figure 4 above) and is maintained in tension by its own elasticity or that of the belt 17, or both. This tension causes the

15. limb 101 to be pressed against the anterior vaginal wall 11 directly over the course of the urethra 12. The pressure of the limb 101, and particularly that due to the protuberance 105 causes the urethra 12 to collapse (as shown in Figure 8), so preventing urine

20. flow.

In a first modification of this second embodiment of the device, the necessary support may be increased internally particularly against lateral movement. This may take the form of a rigid loop

25. 118 which is attached to the back or outer face of the limb 101 as shown in Figures 7 and 8 by dashed lines. In this modification, the belt and strap again hold the device in place, the limb 101 being pressed against the anterior vaginal wall 11 in the

30. positon previously described. The loop 118 being pressed against the upper dorsal vaginal wall 19 behind the cervix 20 with the natural elasticity of the vaginal wall 19 helps hold the device in place particularly against lateral movement.

In a second modification of this second embodiment, shown in Figure 9 and in cross section in Figure 10, the device is shaped so as to be held in place between the anterior and dorsal vaginal 5. walls 11, 21, proximate the vaginal entrance as well as being held in place by the belt and strap. The limbs 101 and 102 are generally as described above for the first modification of the second embodiment but the base of the U or V is extended to form a 10. generally saddle-shaped protrusion 122, moulded to conform with the general shape of the lower dorsal vaginal wall 21. In use, the device is held in position by the combined pressure of the anterior wall 11 on the upper limb 1 and that of the dorsal 15. wall 21 on the saddle-shaped protrusion 122 as well as the belt and strap. The protrusion 122 is provided with a generally vertically-disposed duct 123 extending between its upper and lower surfaces, which duct serves to allow egress of natural vaginal 20. fluids and enables the device to be removed easily, and if desired wings 122B and C (not shown) as described above for Figure 5.

It is not essential for the limb 101 to extend as far into the vagina as shown in Figure 8. It 25. may be shorter, provided that it extends far enough above the urethral opening 14 to allow the occlusion of the urethra 12 without significant leakage. The protuberance 105 at the end of the limb 101 is likewise not essential to the invention; the 30. pressure of the limb 101 alone on the urethra 12 can be sufficient to cause it to collapse but the protuberance aids certainty of operation.

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The device may be made of any suitably flexible material such as rubber, or it may be made of a more rigid material such as polypropylene, and provided with pads of compressible material, for comfort, in

5. the necessary regions. The structure should be sufficiently rigid to ensure secure location in the vagina, and to enable the force exerted by the strap 15 to pull the limb 101 and the protuberance 105 against the interior vaginal wall 11 sufficiently

10. hard to occlude the urethra 12. If the device is made of a generally rigid material the base of the U, between the limbs 101 and 102, may be made of a more flexible material to allow some hinging movement between the limbs , thus accommodating

15. personal differences in vaginal shape. When the loop 118 is present the hinging embodiment may be used or the device may be made of a more flexible material throughout.

Referring now to Figures 11 to 14 the device in

20. this third embodiment is a polypropylene moulding about 3 nuns thick. The device before insertion has a shepherd-crook longitudinal cross section having a long straight portion 52 corresponding to the limb 102 having a connecting link 66 at its free end and

25. broadening into a paddle shaped end 75 at the end where it curves round to form a broadened plate 51 of egg shaped plan view corresponding to the limb 101 in the first embodiment. This plate 51 is curved inwardly in cross section towards the portion

30. 52 so as to afford a protuberance 55 effective to

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apply pressure to the urethra and thus occlude it in use. The straight portion 76 of the limb 52 is preferably sheathed in soft polymer or rubber 77 so as to prevent discomfort or excoriation of the 5. mucous membrane at the lower end and may be made sufficiently flexible to conform in use to the user's body as shown in Figure 14. The edges 74 of the plate 51 are carefully moulded to rounded shapes with the same aim in mind, and in addition the soft 10. sheathing may extend to cover the plate 51 as is also shown at 78 in Figure 14.

Referring now to Figures 15 to 18 these fourth and fifth modifications of the second embodiment are both concerned with restrictive versions of the 15. invention in which the occlusion means can either be overcome by the user (Figures 15 and 16) by internal muscular effort or controlled by external action (Figures 17 and 18) .

The arrangement shown in Figures 15 and 16 has 20. an inner or upper limb 151 and an outer or lower limb 152 from the end of which extends tensioning means (indicated diagrammatically at 15) as in the other embodiments. The upper end of the inner limb 152 is oval in cross section (Figure 16) the rigid 25. back face 155 carrying a compressible cushion 157, e.g. having a foam or fluid filled interior 156 and an impervious covering 158. This cushion is of such compressibility as under the pressure of the tensioning means 15 exerted via the back face 155 30. to occlude the urethra and prevent urine flow but

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also to be capable of being further compressed when muscular pressure is exerted on the bladder to force urine down the urethra and past this cushion 157. The arrangement in Figures 17 and 18 has the

5. cushion 157 replaced by a fluid filled bag, e.g. an airbag 160, again mounted on the front side of the rigid back 155 and connected via a tube 161 with a small hand operable pump 162 which in use is located outside the body. In use the pump can be used to

10. inflate the airbag, e.g. to the position shown in dotted lines in Figure 18 to shut off urine flow. The pump 162 is also provided with a release valve 163 so that the airbag can be easily deflated to permit discharge of urine.

_] _5 In both these embodiments, which permit use of the device without removal from the vagina, duct means will be provided to allow discharge of urine. Such a duct may merely be an opening through the device, e.g. the limb 151 or may be a duct such as

20. shown in the arrangement of Figures 1 to 6.

Referring now to Figures 19 and 20 these show the third embodiment of the invention, the stress incontinence version.

Here the inner limb 201 is generally of spoon

25. shape whilst the outer limb 202 is narrower. Again the tensioning means extend away from the end of the limb 202 as in the other embodiments and as illustrated diagra matically at 15. A slot-like duct 205 extends around the bend which joins the

30. limbs 201 and 202 enabling urine to be discharged

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from the urethral opening 14 without the device needing to be removed from the vagina. The top edge 206 of the inner limb 201 holds the users urethra in or near the normal position and reduces or alleviates stress incontinence.

The arrangement in Figure 20 has a further feature in the dorsal extension 207 which is akin to the extension 1A shown in Figure 3B and is of similar duck-bill shape and extent (extending to

10 near the cervix but stopping short thereof and extending across the vagina) and function (helping to maintain lateral location) .

In modifications of the arrangements of Figures 19 and 20 the overcomeable or controllable cushion 15. or airbag features of Figures 15 to 18 are incorporated into the structures of the Figure 19 and 20 embodiments.