A female incontinence device comprising a support adapted for insertion into and stable retention in the vagina, a flexible diaphragm engaged at its periphery with the support, and remotely operable means carried by the support to elevate the diaphragm relative to the support and thereby upwardly displace both the urethra and bladder neck, while slightly elongating the urethra.
Field of Search:
1. A female incontinence device comprising:
2. A device according to claim 1 wherein said body has an undersurface, including said base, which is concave in the lateral direction.
3. A device according to claim 1 wherein said cavity has opposed sidewall portions in the longitudinal sides of said second shape which overhang said undersurface.
4. A device according to claim 1 wherein the part of said body defining the rim of said aperture is turned over into said cavity to form an annular groove, and said device comprises a spring seated in said groove to retain said diaphragm located across said aperture.
5. A device according to claim 1 wherein said inflation means comprises a balloon located in said cavity, a collapsible fluid reservoir located externally of said body, a flexible tube communicating said balloon and reservoir to form a sealed fluid system, and means for mutually isolating the interiors of said balloon and said reservoir.
This invention relates to an incontinence device.
The object of the invention is to provide a device which can be inserted into a female patient and enable the patient or her attending nurse to have control over incontinence of urine.
According to the present invention there is provided a female incontinence device comprising a support adapted for insertion into and stable retention in the vagina, a flexible diaphragm engaged at its periphery with said support, and remotely operable means carried by said support to elevate said diaphragm relative to the support and thereby to upwardly displace both the urethra and bladder neck, while slightly elongating the urethra.
The alteration of the relationship between the urethra and the bladder by the upward displacement of the urethra is the action whereby the device achieves continence of urine.
The pressure of the diaphragm on the urethra from the vagina may also assist in achieving continence by improving the resistance of the urethra to the involuntary escape of urine. When intra-abdominal pressure is raised no escape of urine takes place from the urethra when the diaphragm is elevated.
The support of the proposed device preferably takes the form of a suitably anatomically shaped member mould from acrylic or other plastics material which is acceptable from both the medical and production points of view.
Preferably the remotely operable means for elevating the diaphragm takes the form of a fluid expansible vessel. In the case of a molded support member, the member is conveniently hollowed to receive a vessel in the form of a balloon held captive in the support member hollow by the diaphragm. The fluid for expanding the vessel, such as air for inflating a balloon-form vessel, can be supplied via a narrow flexible tubing from an external reservoir or a simple hand pump.
The diaphragm itself can be a simple contraceptive type of diaphragm made of rubber or other flexible material incorporating a metal ring or spring around its edges, which holds the diaphragm in place by engagement in a suitable seating in the support.
In the case where a fluid expansible vessel is used, it is possible that the diaphragm may be unnecessary if the vessel is otherwise connected with the support.
The invention has particular application in women with urinary incontinence who are not suitable for surgical treatment or who have not been improved by operations aimed at restoring continence. Where the patient is in such circumstances that she cannot follow the simple instructions then the nurse or attendant can easily operate the device to keep the patient free of incontinence of urine.
In order that the invention may be more fully understood, the same will now be described, by way of example, with reference to the accompanying drawings, in which:
FIGS. 1 and 2 are longitudinal sections through a device according to the invention showing the diaphragm lowered in FIG. 1 and elevated in FIG. 2,
FIGS. 3 and 4 are transverse sections through the same device again with the diaphragm lowered and elevated, respectively,
FIGS. 5 and 6 show a closed pneumatic system for elevating and lowering the diaphragm of a device such as that illustrated by FIGS. 1 to 4, and
FIG. 7 illustrates the device in plan view.
The device illustrated in FIGS. 1 to 4 and 7 comprises an anatomically shaped support member 10 molded from acrylic plastics material. The member 10 is formed with a hollow to form a chamber 11 when covered by a rubber diaphragm 12. The diaphragm 12 is held in place around its periphery by a retaining spring 13 received by a seating 13a formed around the mouth of the hollow in the support member.
Within the chamber 11 is a rubber balloon 14 adapted to be supplied with air through a flexible tube 15. The flexible tube 15 and balloon 14 are also shown in FIGS. 5 and 6 and the tube 15 is connected to a rubber air reservoir 16 via a valve 17 which consists of a simple compression roller clip. The rubber reservoir 16 has an air filling valve 18. In FIG. 5 the reservoir 16 is shown full of air and the balloon 14 is deflated, but in FIG. 6 the reservoir 16 is compressed and the air has gone into the balloon 14.
The air reservoir 16 might alternatively have been made of polythene or other flexible plastics material.
In use the device is inserted into the vagina, the end marked 10a being the posterior end and the end marked 10b being the anterior end. When the patient wishes to micturate she allows the air to pass from the internal balloon 14 to the reservoir 16 by operating the compression roller clip valve 17. After micturation is complete the external reservoir is compressed which will inflate the internal balloon. The roller clip is then closed to maintain air within the balloon.
The external reservoir can initially be filled by means of a disposable plastic syringe via valve 18.
As clearly shown in the drawing, the female incontinence device includes a vaginal insert body which is generally triangular in side silhouette (FIGS. 1 and 2), the triangular form including a base, a first side, and a second side, for respective longitudinal, inferior, and superior disposition in the vagina. Near its inferior end, the vaginal insert body is generally triangular in top plan view, having a first upper surface portion, including said first side, converging towards the inferior end of said body, a second upper surface portion, including said second side diverging towards the superior end of said body, and a cavity opening into an aperture in said first upper surface portion. There is a flexible diaphragm 12 located across said aperture and inflation means 14 located in said cavity and remotely operable via 15 to elevate said diaphragm from said first upper surface portion. The body 10 has an undersurface, including said base, which is concave in the lateral direction (FIGS. 3 and 4). The cavity 11 has opposed sidewall portions (FIGS. 3 and 4) at its longitudinal sides which overhang said undersurface. Part of the body defining the rim of the aperture is turned over into the cavity 11 to form an annular groove (FIGS. 1-4), and a spring 13 seated in the groove to retain the diaphragm 12 located across the aperture. The inflation means includes a balloon 14 located in the cavity, a collapsible fluid reservoir 16 (FIGS. 5 and 6) located externally of said body, a flexible tube 15 communicating the balloon and reservoir to form a sealed fluid system, and means such as a clip 17 for mutually isolating the interiors of the balloon and the reservoir.