GB2147809A

GB2147809A - Urethral occlusion device

Info

Publication number: GB2147809A
Application number: GB08325847A
Authority: GB
Inventors: Thomas George Eakin
Original assignee: Individual
Current assignee: Individual
Priority date: 1983-09-27
Filing date: 1983-09-27
Publication date: 1985-05-22
Also published as: GB8325847D0; ZA847590B

Abstract

A urethral occlusion device (1) for use by females is generally shaped so as to contact the anterior vaginal wall and to extend out of the vaginal opening and being particularly shaped so as to be adapted to cause occlusion of the urethra (12) on being urged against the anterior vaginal wall above the urethral opening. A preferred means for urging the device against the interior vaginal wall is an external tensioning device connection (15) between the portion of the device (2) which extends out of the vaginal opening and for example a belt worn by the user. <IMAGE>

Description

SPECIFICATION Urethral occlusion device The present invention relates to a urethral occlusion device particularly adapted for the use of incontinent female 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 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 clothing has little more than an external cosmetic effect, and since urine flow is not prevented the patient remains continually wet and uncomfortable.

The present invention consists of a simple moulded device designed to occlude the urethra which can be worn in the vagina, and which significantly overcomes these problems in that it can easily be inserted and 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.The invention retains one of the advantages of the catheter, moreover, in that the urine can still be collected, observed and its volume measured for diagnostic purposes.

The device is shaped so as to contact Ihe 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 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. 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 two limbs may be of substantially equal length, though this is not essential; the upper limb may be considerably shorter. The upper limb may be provided with a forwardly facing protuberance, the pressure of which on the vaginal wall causes or assists the urethral occlusion.

The occlusion may be caused to occur in several ways, one of which is by the tension of some means connecting the second limb to an anchorage located on the user's body. A cord or strap attached to a belt is a convenient method of achieving this, the tension being due to the elasticity of the cord or that of the belt or both. A second method is by the provision of a rearwardly extending portion which is pressed against the dorsal vaginal wall; this may be a rigid loop attached to the upper limb, or it may be a portion generally shaped to conform to the lower dorsal vaginal wall proximate to the vaginal opening. In the latter case the extension may be provided with a duct to allow egress of the natural vaginal fluids.The device may be constructed of a suitable flexible substance, such as rubber, or it may be made of a more rigid substance such as polypropylene and provided with soft pads as coverings for comfort. It may also be constructed of a rigid substance but be provided with a flexible portion between the limbs allowing hinging motion therebetween and soft pads or coverings may be provided in this case also.

The invention may be put into pactice in various ways, and three specific embodiments will be described by way of example with reference to the accompanying drawings, in which: Figure 1 is a perspective view of the first embodiment of the invention; Figure 2 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 an internal loop (dashed line); Figure 3 illustrates one method of securing the first embodiment in position, in which a strap and belt are used; Figure 4 is a perspective view of a second embodiment of the invention, in which the device is shaped to conform to the vaginal opening; Figure 5 is a medial cross section of the second embodiment illustrating a conduit which allows egress of the natural vaginal fluid;; Figure 6 is a plan view from the front of a third embodiment which is a modified form of the first embodiment; Figure 7 is a medial cross section of the third embodiment; Figure 8 is a plan view from the rear; and Figure 9 is a cross section similar to Figure 2 showing the third embodiment in use.

In the first embodiment, the invention takes the form shown in Figure 1 and consists of two integrally connected limbs 1,2. The limbs 1 and 2 together provide a generally U or V-shaped configuration, the inner face 3 of the lower limb 2 being generally flat or concave. The inner face 4 of the upper limb is generally flat or convex and terminates in an inwardly-facing protuberance 5, of which the edges are rounded as shown in Figure 1.

In use, the limb 1 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 2 with the limb 1 being placed against the anterior vaginal wall 11, following the line of the urethra 12.

The lower limb 2 points forwardly and is positioned against the outer surface of the body within the vulva 13. The device may be held in position in several ways, one of which is by means of a strap 15 which is attached to or is a continuation of the lower limb 2 at its forward end 16. The strap 15 (which may be padded for comfort) may conveniently be attached to a belt 17 as shown in Figure 3 and is maintained in tension by its own elasticity or that of the belt 17, or both. This tension causes the limb 1 to be pressed against the anterior vaginal wall 11 directly over the course of the urethra 12. The pressure of the limb 1, and particularly that due to the protuberance 5 causes the urethra 12 to collapse, so preventing urine flow.

In a modification of the device, the necessary support may be provided internally in the form of a rigid loop 18 which is attached to the outer face of the link 1 as shown in Figures 1 and 2 by dashed lines. In this modification, the belt and strap are not required (though they may be retained), the device being placed in position with the loop 18 pressed against the upper dorsal vaginal wall 19 behind the cervix 20. The natural elasticity of the vaginal wall 19 holds the device in place and causes the limb 1 to be pressed against the anterior vaginal wall 11 in the position previously described.

in a second embodiment, shown in Figure 4 and in cross section in Figure 5, the device is shaped so as to be held in place between the anterior and dorsal vaginal walls 11, 21, proximate the vaginal entrance. The limbs 1 and 2 are generally as described above for the first embodiment but the base of the U or V is extended to form a generally saddle-shaped protrusion 22, 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 wall 21 on the saddle-shaped protrusion 22. The protrusion 22 is provided with a generally vertically-disposed duct 23 extending between its upper and lower surfaces, which duct serves to allow egress of natural vaginal fluids and enables the device to be removed easily.

It is not essential for the limb 1 to extend as far into the vagina as shown in Figure 2. It 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 5 at the end of the limb 1 is likewise not essential to the invention; the pressure of the limb 1 1 alone on the urethra 12 can be sufficient to cause it to collapse but the protuberance aids certainty of operation.

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. When the device is held in place by the strap 15 and the belt 17, 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 and the protuberance 5 against the interior vaginal wall 11 sufficiently hard to occlude the urethra 12. 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 hinging movement between the limbs, thus ac commodating personal differences in vaginal shape.When the loop 18 is relied on to hold the device in place, the hinging embodiment may be used or the device may be made of a more flexible material throughout.

The use of a non-reactive material may be useful to patients with allergies to rubber or silicone products.

Referring now to Figures 6 to 9.the device in this third embodiment is a polypropylene moulding about 3 mms thick. The device before insertion has a shepherd-crook longitudinal cross section having a long straight portion 52 corresponding to the limb 2 having a connecting link 66 at its free end and 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 1 in the first embodiment. This plate 51 is curved inwardly in cross section towards the portion 52 so as to afford a protuberance 55 effective to 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 so as to prevent discomfort or excoriation of the 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 9. The edges 74 of the plate 51 are carefully moulded to rounded shapes with the same aim in mind, and in addition the soft sheathing may extend to cover the plate 51 as is also shown in figure 9.

Claims

1. A urethral occlusion device for use by females, generally shaped so as to contact the anterior vaginal wall and to extend out 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.

2. A urethral occlusion device as claimed in Claim 1 consisting of two limb which together form a generally U or V-shaped configuration, the urethral occlusion being caused by the pressure of a first or upper limb.

3. A urethral occlusion device as claimed in Claim 2 in which the first limb is shorter than the second limb.

4. A urethral occlusion device as claimed in Claims 2 or 3 in which the upper limb is provided with a forwardly facing protuberance, the pressure of which on the vaginal wall causes or assists the urethral occlusion.

5. A urethral occlusion device as claimed in any preceding claim in which in use the occlusion is caused to occur by the tension of means connecting the second limb to an anchorage located on the user's body.

6. A urethral occlusion device as claimed in Claim 5 in which the connecting means is a strap or cord attached at one end to a belt, the tension being due to the elasticity of the cord or that of the belt, or both.

7. A urethral occlusion device as claimed in any of the preceding claims in which the device is held in position by a rearwardly extending portion which is pressed against the dorsal vaginal wall.

8. A urethral occlusion device as claimed in claim 7 in which the rearwardly extending portion is generally shaped so as to conform to the lower dorsal vaginal wall proximate to the vaginal open ing.

9. A urethral occlusion device as claimed in claim 8 in which the rearwardly extending portion is provided with a duct to allow egress of natural vaginal fluids.

10. A urethral occlusion device as claimed in Claim 7 in which the rearwardly extending portion is a rigid loop attached to the first limb.

11. A urethral occlusion device as claimed in any of the preceding claims in which the device is made of a rigid or semi rigid substance and is provided with soft pads or coverings for comfort.

12. A urethral occlusion device as claimed in any of the Claims 1 to 10 in which the device is generally rigid but is provided with a flexible portion between the limbs allowing hinging motion therebetween.

13. A urethral occlusion device as claimed in Claim 12 in which the device is provided with soft pads or coverings for comfort.

14. A urethral occlusion device for the female body substantially as specifically described herein with reference to the accompanying drawings.