NZ222169A - Intra-vaginal, urinary incontinence control device - Google Patents

Description

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NEW ZEALAND PATENTS ACT. 1953 COMPLETE SPECIFICATION URINARY INCONTINENCE DEVICE // ^ \ U /V ^ \ 0\ °AV ,*v V- ,,al-». £ * SN0Vj98f> 7 We. ZEDLANI PTY. LIMITED, a Company incorporated under the laws of the State of New South Wales, of 1 Smith Street, Parramatta, New South Wales 2150, Australia hereby declare the invention for which i/7 we pray that a patent may be granted to ry(e/u.s, and the method by which it is to be performed, to be particularly described in and by the following statement: - 222169 The present invention relates to a device for controlling urinary incontinence and vaginal and rectal prolapse in females. Particularly, the invention relates to a device which may be removably inserted into the vagina.

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 the pelvic floor muscle. On coughing or sneezing or physical exercise, i.e. when strain is put upon the bladder, an involuntary spurt of urine is released from the bladder. This involuntary urine release is unpleasant and embarrassing. The released urine may irritate the groin region and 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. These conditions may be painful, and uncomfortable. Additionally, sexual intercourse may be impaired by occlusion of the vagina. 222169 It is a generally accepted view that surgical treatment is most appropriate for cure of stress incontinence and vaginal rectal 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 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 often fail to prevent involuntary urinary leakage.

An annular device which aids in controlling vaginal and rectal prolapse and urinary incontinence is disclosed in our New Zealand patent specification No. 224254.

The object of the present invention is to provide an intra-vaginal device to aid in controlling vaginal and rectal prolapse and urinary incontinence.

The intra-vaginal device of the present invention can in broad terms be said to comprise a first limb and a second limb which are joined to a flexible base having an aperture, wherein said limbs extend in substantially the same direction from said base, two projections separated by a depression are provided at the distal end of said first limb to form a cradle and, a pair of splayed legs are provided at the distal _ end of . . -S said second limb. 222169 The base portion is preferably arch shaped, and is preferably comprised of a resilient material or has resilient material embedded within the arch.

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.

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

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

Preferably, the opposing inner surfaces of the two ^ limbs are covered by a spongy deformable material bearing complementary grooves and ridges. This material imitates vaginal mucosa. Sexual intercourse is therefore not affected by the device as the spongy material cannot readily be distinguished by the male partner. Additionally, the grooves and ridges aid in channelling menstrual blood and vaginal secretions through the vagina. ; t r f.-A J /;!■ 17/:' 222169 The present invention will now be described by way of example only with reference to the following drawings, in which: Fig. 1 is a perspective view of the intra-vaginal device; Fig. 2 is a side view of the intra-vaginal device; Fig. 3 is an end view of the intra-vaginal device; Fig. 4 is a schematic view of a saggital section of the female pelvic organs showing the intra-vaginal device in place; Fig. 5 is a schematic perspective view of an intra-vaginal device to aid in controlling urinary incontinence; and Fig. 6 is a schematic view of a saggital section of the female pelvic organs showing the device of Fig. 5 in place.

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

The device comprises a base portion 10 which forms an arch 12 of generally "U-shaped" configuration. The base.^portion '" C . may be inherently resilient or may contain a resilient insert. The arch 12 contains an aperture 13 which in ' ** v ' 1 V /• 3 222169 adjacent the cervix of the uterus. The arch 12 interconnects two opposing limbs 14 and 16. The limb 14 lies adjacent the "•K. 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 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, thus holding the device in place.

'W' As shown in Fig. 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 caused by the bladder 25 pressing against the anterior vaginal wall 2 4 (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 continence. Additionally, a significant closure of the bladder neck is achieved as is a reduction of the included angle between the urethra and the bladder. "These features again increase continence. . -4 j.v s::.; 222169 The arch 12 supports the cardinal and uterosacaral ligaments (not shown) and helps to lift the uterus in the pelvic cavity thereby preventing uterine prolapse. The aperture 13 in the arch 12 lies adjacent the cervix 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 (enterocele) and rectal prolapse (rectocele). The legs 22 of the limb 16 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, thus aiding in retention of the device in the vagina.

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 minimise vaginal irritation.

In a further embodiment of the present invention as shown in Figs 5 and 6, a small inflatable balloon 28 may be ^ provided between the projections 28. The balloon 28 may be inflated to compress the bladder neck against the pubic symphysis thus closing off the urethra resulting in continence. The balloon 28 may be inflated/deflated by virtue of a small lead connected to the balloon 2 8 which passes out of the vagina where it can be manipulated by the patient.

The device shown in the accompanying drawings can be 222 placed in position by a medical practitioner without anesthetic, with immediate results achievable.

The foregoing describes the invention including a preferred form thereof. Alterations and modifications as will be obvious to those skilled in the art are intended to be incorporated in the scope of the invention as defined by the following claims. 222169

Claims (8)

WHAT WE CLAIM IS:

1. An intravaginal device for insertion in a human patient comprising a first limb and a second limb which are joined to a flexible base having an aperture, wherein said limbs extend in substantially the same direction from said base, two projections separated by a depression are provided at the distal end of said first limb to form a cradle and, a pair of splayed legs are provided at the distal end of said second limb.

2. A device according to claim 1, wherein an expandable member is provided between the projections.

3. A device according to claim 2, wherein the expandable member is a balloon.

4. A device according to any preceding claim, wherein the device is composed of a resilient material.

5. A device according to any one of claims 1 to 3, wherein resilient material is embedded within the base portion.

6. A device according to any preceding claim, wherein the base biases the first and second limbs away from each other.

7. A device according to any preceding claim, wherein in use the projections can engage the anterior vaginal wall of the n - 10 - 222169 patient while the legs engage the perineal body of the patient and the base engages with the cervix of the patient.

8. An intra-vaginal device substantially as herein described with reference to the accompanying drawings. r™) WEST-WALKER, McCABE per: ATTORNEYS FOR THE APPLICANT 1 !■ ^ / \/-4 J A"