AU606408B2

AU606408B2 - Female incontinence device

Info

Publication number: AU606408B2
Application number: AU14650/88A
Authority: AU
Inventors: Nicholas Biswas
Original assignee: Zedlani Pty Ltd
Current assignee: Zedlani Pty Ltd
Priority date: 1986-10-14
Filing date: 1988-04-14
Publication date: 1991-02-07
Anticipated expiration: 2007-10-13
Also published as: AU1465088A

Description

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S F Ref: 56222 FORM '7 COMMONWEALTH OF AUSTRALIA SPATENTS ACT 1952 '-OMPLETE SPECIFICATION

(ORIGINAL)

0 00 9 0; 0 0*0 0 9 09 000984 0 9 0 0 0 0 v~ 0990 bOO 0 0 *00 40 '3 0 FOR OFFICE USE: Class Int Class Complete Specification Lodged: Accepted: Published: Priori ty: Related Art: Name and Address 2 PYM- I Is 4 of Applicant: 4-i'-cG-a-s-8--wa.s -9-G-r-a-f-to n--t-r-e e-t PA"eC,^C 211 B--&c-kewf~-New-Su-t-hWa-e-s-2448- -AUSr-TRAL--A- Ao,% c- Address for Service: Spruson Ferguson, Patent Attorneys Level 33 St Martins Tower, 31 Market Street Sydney, New South Males, 2000, Australia Complete Specification for the invention entitled: Nicholas Biswas The following statement is a full description of this invention, including the best method of performing it known to me/us 5845 /3 The present invention relates to devices for controlling urinary incontinence and to vaginal and rectal prolapse in females. Particularly, the invention relates to a device which may be removably inserted into the vagina.

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Female urinary incontinence is a common problem and is particularly prevalent where damage to the bladder or neck of the bladder has occurred during child birth. In elderly female patients, urinary incontinence is wide spread.

In normal continent patients, in the erect posture, there is no descent of the bladder neck below the pelvic floor muscle, thereby equal distribution of intra-abdominal pressure to the bladder and bladder neck and pelvic urethra occurs, and continence is maintained. However, in stress incontinence this is lost due to descent of the bladder neck below Ow. the pelvic floor muscle. On coghing or sneezing or physical exercise, i.e. when strain is put upon the bladder, an involuntary spurt of urine is S released from the bladder. This involuntary urine release is unpleasant and embarrassing. The released urine may irritate the groin region and S result in an offensive odour.

Vaginal and rectal prolapse are quite common conditions in females, particularly those who have vaginally delivered one or more children.

d These conditions may be painful, and uncomfortable. Additionally, sexual intercourse may be impaired by occlusion of the vagina.

It is a generally accepted view that surgical treatment is most appropriate for cure of stress incontinence and vaginal and rectal 25 prolapse. However, in elderly or infirm patients the risk of surgery is too great, so that often these conditions go untreated.

Previously proposed devices to treat incontinence and avoid recourse *044 to surgery have generally been unsatisfactory. Particularly, they are cumbersome, difficult to use, need to be replaced frequently, are inadequate in cases of permanent incontinence and oft2n fail to prevent involuntary urinary leakage.

A previously known intra-vaginal device for controlling urinary incontinence in females is disclosed in US Patent 4,139,006. This previously known device has as its object the deflection of the urethra.

More particularly it has the object of displacing a surface of the superior wall of the vagina, and an intermediate section of the urethra adjacent thereto, toward to pubic bone, to reduce the urethro-visicle angle to restore the patient's natural control over the flow of urine through the urethra from the bladder to the urethral opening. The device has a pair of DG:0751t -2i i- rhk/8401T m nnn forward projections which lie on either side of the urethra intermediate portion and apply a force thereto to deflect the intermediate portion of the urethra toward the pubic bone.

There is disclosed herein an entirely intra-vaginal urinary incontinence device comprising a planar resilient annulus having integrally formed thereupon two projections which extend upwardly from the plane of the annulus, the projections defining therebetween a cradle adapted to engage the anterior vaginal wall and lift the bladder adjacent the bladder neck.

Preferably, the cradle-like structure, which lifts the bladder base and bladder neck, is formed by two protrusions extending from the free end of the limb which lies adjacent the anterior vaginal wall. These protrusions have a depression therebetween. This depression accommodates .the anterior vaginal wall and the neck and base of the bladder.

Aoo.15 In use, the base portion biases the limbs outwardly to aid in 0 0 retention of the device in the vagina.

ooo° The limb adjacent the posterior vaginal wall preferably has two legs at its free end. These legs may be curved and splayed in order to fit over o0,, the perineal body for supporting the device in the vagina.

There is also disclosed herein an intra-vaginal device to aid in controlling urinary incontinence in females, said device having a central o oo 0 0 0 o o e l b~,ai3 rhk/0175E I- ~i I portion of an arcuate cupped configuration and shaped to be retained, within the vagina of a user, in an upwardly convex configuration, a rearward portion extending rearwardly -fi-om-sa-i-d--nt-r-a-l-per-t--en-to engage the posterior vaginal wall, a forward portion extending upwardly from said central portion to engage the anterior vaginal wall adjacent the bladder neck and to lift the bladder portion located adjacent thereto, a bladder neck cradle provided by said forward portion positioned to cradle the bladder neck, and wherein said device is formed of resiliently deformable material so as to flex into engagement with the posterior and anterior vaginal wall to retain the device in its upwardly convex position with the forward portion lifting the bladder and cradling the bladder neck.

Still further, it is preferred that the above described ring would be adjustable in diameter.

The present invention will now be described by way of example only '15 with reference to the following drawings, in which: Figure 1 is a perspective view of the intra-vaginal device; Figure 2 is a side view of the intra-vaginal device; Figure 3 is an end view of the intra-vaginal device; Figure 4 is a schematic view of a saggital section of the female pelvic organs showing the intra-vaginal device in place; Figure 5 is a schematic perspective view of an intra-vaginal device to aid in controlling urinary incontinence; Figure 6 is a schematic view of a saggital section of the female pelvic organs showing the device of Figure 5 in place; 4'"25 Figure 7 is a schematic bottom plan view of a further intra-vaginal device to aid in controlling urinary incontinence; Figure 8 is a schematic sectioned side elevation of the device of S Figure 7 sectioned along the line 8-8; and Figure 9 is a schematic end elevation of the device of Figure 7.

The intra-vaginal device shown in Figure 1 is constructed of a flexible material, for example a plastic/silicone compound.

The device comprises a base portion 10 which is of an arcuate form.

In this embodiment the base portion forms an arch 12 of generally "U-shaped" configuration. The base portion 10 may be inherently resilient or may contain a resilient insert. The arch 12 contains an aperture 13 which in use is adjacent the cervix of the uterus. The arch 12 interconnects two opposing limbs 14 and 16. The limb 14 lies adjacent the S anterior vaginal wall in use and has at its end two opposed rounded projections 18 having a depression 20 therebetween to form a cradle-like 4, therebetween 4 ~t v i'

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a 4 structure.

The limb 16 extending from the arch 12 is of substantially planar construction and has at its forward end a pair of splayed legs 22.

The flexible and resilient nature of the arch 12 enables the device to be readily inserted into the vagina and aids in its retention therein.

Particularly, the arch 12 biases the limbs 14 and 16 outwardly, causing them to press against the anterior and posterior walls of the vagina respectively, this holding the device in place.

As shown in Figure 4, when the device is inserted into the vagina, the limb 14 lies adjacent to and supports the anterior vaginal wall 24 preventing prolapse of the anterior vaginal wall (cystocele) and prolapse Scaused by the bladder 25 pressing against the anterior vaginal wall 24 (cysto-urethrocele). The outward bias of the limb 14 causes the projections 18 to cradle the anterior vaginal wall 24 and lift the neck and base of the bladder above the pelvic floor muscle thereby causing Scontinence. Additionally, a significant closure of the bladder neck is Sachieved as is a reduction of the included angle between the urethra and the bladder. These features again increase continence.

The arch 12 supports the cardinal and uterosacaral ligaments (not shown) and helps to lift the uterus in the pelvic cavity thereby preventing i uterine prolapse. The aperture 13 in the arch 12 lies adjacent the cervix i of the uterus.

The limb 16 lies adjacent to and supports the posterior vaginal wall 26, thereby preventing prolapse of the posterior vaginal wall 26 i 25 (enterocele) and rectal prolapse (retocele). The legs 22 of the limb 14 rest on the posterior vaginal wall 26 in the region of the para-rectal fossa 27. The splayed nature of the legs enables them to fit over the perineal body, this aiding in retention of the device in the vagina.

oIoaa4 'The device may be of different sizes to accommodate different vaginal size. Preferably, those portions of the device contacting the vaginal wall are smeared with Disaestrol and Sultril cream in order to minimize vaginal irritation.

In a further embodiment of the present invention as shown in Figs. and 6, a small inflatable balloon 28 may be provided between the projections 18. The balloon may be inflated to compress the bladder neck against the public symphasis thus closing off the urethra resulting in continence. The balloon 18 may be inflated/deflated by virtue of a small lead connected to the balloon which passes out of the vagina where it can be manipulated by the patient.

DG:0751t 1 i ii i In Figures 7 to 9 there is schematically depicted an intra-vaginal device to aid in controlling urinary incontinence. The device 30 is formed of resilient material so that in use it is resiliently deformed within the vagina so as to be biased outward into contact with the posterior and anterior vaginal wall. The device is about 8 cm in diameter. The device includes a central portion 31 of an arcuate cupped configuration having an aperture 32 to allow for the discharge of menstrual blood and vaginal secretions.

which in this particular embodiment comprises a pair of rearwardly extending projections 34.

Also extending from the central portion 31, is a forward portion which projects generally upwardly and in use, extends both forwardly and upwardly to engage the anterior vaginal wall adjacent the bladder neck.

f ,p'15 The forward portion 35 includes a pair of upwardly extending projections 36 which engage the anterior vaginal wall to lift the bladder adjacent the Sbladder neck. The projections 36 are about 2 cm high. Defined between the portions 36 is a cradle 37 within which the bladder neck lies to be cradled H thereby. It should be appreciated that the pressures applied to the bladder neck are minimized by the cradle neck 37.

Preferably the device 37 would be integrally formed of moulded elastomeric material having sufficient resilience so that upon being :I deformed and inserted in the vagina, the rear portion 33 and forward j portion 35 are resiliently biased into contact with the posterior and anterior wall of the vagina.

The central portions 31 have sides 38 which also engage the sides of Litt the vaginal wall to aid in retaining the device 30 in position, that is S, concaved upwardly so that the forward portion 36 engages the anterior vaginal wall adjacent the bladder.

In the above embodiment the device 30 is preformed so as to be "cup" shaped. However, the central portion 31 could be of a more planar configuration, so that in position within the vagina it is resiliently deformed into an arcuate or "cup" shaped configuration.

The above discussed preferred embodiments of the present invention have the advantage that they may be placed in position by a medical practitioner without anaesthetic, with immediate results achievable.

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Claims

1. An intra-vaginal device to aid in controlling incontinence in females, said device having a central portion of an arcuate cupped configuration and shaped to be retained, within the vagina of a user, in an upwardly convex orientation, a rearward portion extending rearwardly -iem -said ete-l-p e -en to engage the posterior vaginal wall, a forward portion extending upwardly from said central portion to engage the anterior vaginal wall adjacent the bladder neck and to lift the bladder portion located adjacent thereto, a bladder neck cradle provided by said forward portion positioned to cradle the bladder neck, and wherein said device is formed of resilient material so as to flex into engagement with the posterior and anterior vaginal wall to retain the device in its upwardly convex position with the forward portion lifting the bladder and cradling the bladder neck. 0

2. The device of Claim 1 wherein said rear portion is a pair of rearwardly extending projections, and said forward portion is a pair of 00 upwardly extending projections, between which said cradle is located.

3. The device of Claim 2 wherein said central portion has an aperture to provide for the discharge of menstrual blood and vaginal secretions.

4. The device of Claim 3 wherein said drvice is integrally moulded from elastomeric material.

An entirely intra-vaginal urinary incontinence device comprising a planar resilient annulus having integrally formed thereupon two projections which extend upwardly from the plane of the annulus, the o projections defining therebetween a cradle adapted to engage the anterior o vaginal wall and lift the bladder adjacent the bladder neck.

6. The device of claim 5, wherein: the two projections extend forwardly beyond the periphery of the annulus. 000Q06

7. An intra-vaginal device substantially as hereinbefore described with reference to Figs 7-9. DATED this TWENTY-SEVENTH day of JULY 1990 Nicholas Biswas Patent Attorneys for the Applicant SPRUSON FERGUSON 7 oitoedt cal tebldernc.,ad hrensaddvieisfrmdo '1 re il en at ria so a o f e n o e g g me t w t h o t r o n rhk/0175E Y-L