NZ224254A - Intra-vaginal urinary incontinence control device - Google Patents

Description

/ W-1' c 224254 Priority Date(s): Con^iste Specification Filed: Publication Date: . fl&Y. P.O. Journal. No: G Patents form No 5 PATENTS ACT 1953 COMPLETE SPECIFICATION URINARY INCONTINENCE DEVICE Number Dated G J/WE ZEDLANI PTY. LIMITED a company incorporated under the laws of the State of New South Wales, Australia, of 1 Smith Street, Parramatta, New South Wales 2150, Australia do hereby declare the invention for which #we pray that a Patent may be granted to xdc/us, and the method by which it is to be performed, to be particularly described in and by the following statement: • 1 - ,1 224254 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 bladderneck 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. ! *-4 JAN 1991r: ;- 3 - ;224254 ;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. ;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 the 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 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. ;- - i'i ;A substantially u-shaped intra-vaginal device^which ;. *1. ^-4 JANV391-;, aids in controlling vaginal incontinence is disclosed specification No 222169. and rectal prolapse and urinary in our New Zealand patent 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 an annulus having an annulus having a first face, a second face, a first edge portion and an opposing second edge portion, wherein two projections project from said first face adjacent said first edge portion, and a pair of protrusions separated by a depression extend from said second edge portion.

The annulus can be planar but is preferably dished.

The device is preferably comprised of a resilient material or has resilient material embedded therein.

The present invention will now be described by way of example only with reference to the accompanying drawings, in which: Fig. 1 is a schematic bottom plan view of the preferred form of intra-vaginal device to aid in controlling urinary incontinence. 224254 Fig. 2 is a schematic sectioned side elevation of the device of Figure 1 sectioned along the line 8-8; and Fig. 3 is a schematic end elevation of the device of Figure 1.

The device 30 depicted in Figures 1 to 3 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 walls. The device is about 8 cm in diameter. The device 30 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.

Extending rearwardly from the central portion 31 is a rear portion 33 which comprises a pair of rearwardly extending protrusions 34.

Also extending from the central portion 31, is a forward portion 35 which projects generally upwardly and in use, extends both forwardly and upwardly to engage the anterior vaginal wall adjacent the bladder neck. The forward portion 35 includes a pair of upwardly extending projections 36 which engage the anterior vaginal wall to lift the bladder adjacent the bladder neck. The projections 36 are about 2 cm high. Defined between the projections 36 is a cradle 37 within which the bladder neck lies to be cradled thereby. It should be appreciated that the pressures applied to the bladder^ei2|s^are jX, r- 7 s •''T/nv minimized by the cradle 37. 1 "V •1 ■ ^ 224254 Preferably the device 30 would be integrally formed of moulded elastomeric material having sufficient resilience so that upon being deformed and inserted in the vagina, the rear portion 33 and forward portion 35 are resiliently biased into contact with the posterior and anterior walls of the vagina.

The central portions 31 have sides 38 which also engage the sides of the vaginal wall to aid in retaining the device 30 in position, that is concaved upwardly so that the forward portion 35 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 device shown in the accompanying drawings can be placed in position by a medical practitioner without anaesthetic, 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. 22425

Claims (7)

WHAT WE CLAIM IS:

1. An intra-vaginal device for insertion in a patient comprising an annulus having a first face, a second face, a first edge portion and an opposing second edge portion, wherein two projections project from said first face adjacent said first edge portion, and a pair of protrusions separated by a depression extend from said second edge portion.

2. A device according to claim 1, wherein the annulus is dished.

3. A device according to claim 1, wherein the annulus is substantially planar.

4. A device according to any preceding claim, wherein the two projections extend beyond the perimeter of the annulus.

5. A device according to any preceding claim, wherein the device is composed of a resilient material or resilient material is embedded therein.

6. A device according to any preceding claim, wherein in use the projections can engage the anterior vaginal wall of the patient while the protrusions engage the posterior vaginal wall of the patient. 22425 - 8 -

7. An intra-vaginal device substantially as herein described with reference to the accompanying drawings. WEST-WALKER, McCABE per: ATTORNEY'S FOR THE APPLICANT