GB2129686A - Female incontinence device - Google Patents

Abstract

A female incontinence device is formed principally of a single piece of flexible material which has a pair of deflectable walls 14, 16 which define a channel at the periphery of the device intended to contact the wearer. The device as seen in plan has a "wasted" or approximately "8-shaped" configuration and the deflectable walls as seen in side elevation having sealing edges each of which is constituted by a pair of continuous curves, one on each side of the central longitudinal axis of the device and which extend from a high point at the front of the device to a high point at the rear of the device. <IMAGE>

Description

SPECIFICATION Female incontince device This invention relates to a female incontinence device.

The prior art is replete with attempts to design a completelysatisfactoryfemale incontinence device.

One ofthe greatest problems involved is securing adequate and reliable sealing of the device to the skin of the wearer, bearing in mind the complex shape and thenumerousvariationsfrom persontopersonofthe relevant part of the female anatomy.

One approach is that taken in U.K. PatentApplication Serial No.2090741 involving a seal around the urethral orifice. Another approach is typified by U.S.

Patent 3194238 involving an attemptto make a double seal, one seal by an inner bellows structure andanotherseal byan outerbellowsstructure.

Numerous other attempts have been made, of which the following can be mentioned as examples:~ European Patent Application Serial No.18749.

U.S. Patent3 995329 British Patent 1 522391 U.S. Patent3613 122 U.S. Patent3512 185 German Specification 1766795 U.S. Patent4116 197 U.S. Patent 2483079 British Patent 1 216682 British Patent 1 323190 British Patent 144483 British Patent 1 422 638.

Despite the claims made in these earlier documents, it has in practice proved very difficult to obtain satisfactory sealing, especially when the device is being worn by an active person. Another problem encountered but never properly solved is that with some wearers, there may well be a sudden rapid flow of urine, exiting at considerable pressure, and this gives riseto splashing, and the splashed liquid may cause soreness and maceration and also tends to reduce the security of attachment when an adhesive is used. Yet another problem is that many devices according to earlier suggestions are undesirably rigid and therefore are both uncomfortable to wear and liable to seal inadequately.

The present invention aims to provide an improved female incontinence device.

According to the present invention, there is provided a female incontinence device formed principally of a single piece of flexible material which has a pair of deflectable walls which define a channel at the periphery of the device intended to contactthe wearer, the device as seen in plan having a "waisted" or approximately 8-shaped configuration and the deflectable walls as seen in side elevation having sealing edges each of which is constituted by a pair of continuous curves, one on each side of the central longitudinal axis ofthe device and which extend from a high point at the front of the device to a high point at the rear of the device.

Among the optional features ofthe invention, the following can be mentioned:~ 1. The peripheral sealing obtained bythe groove defined bytwo deflectable walls can be enhanced by squeezing a liquid-repellanttype of cement or adhesive into the groove, this helps to seal the periphery of the device to the person wearing it; 2. the said deflectable walls defining a specially shaped saddle configuration designed to contactthe wearer between the base of the vagina and the anus and located at the rear zone ofthe device in orderto minimise the possibility of leakage at this area, where the riskofleakageisnormallygreatest; 3. an undercut region located beneath the deflectable walls intended to limit splash back; 4. an overall "waisted" or "8-shaped" configuration as seen in plan to improve comfort in wear; and 5. a basin or chamber shaped to conduct all urine directly to an outlet pipe.

The non-irritant cement or adhesive material referred to above is to be understood as a material which can be squeezed from a tube or moulded by hand from a block and which when applied to moist body skin surfaces, is capable of adhesively adhering thereto for a prolonged period of time, for example well over 12 hours, and which, when so used, does not generate any allergic reaction or irritation in the majority of human beings when so adhered. One example of a suitable material is that as "STOMAHESIVE (Registered Trade Mark) and made and sold by E. R. Squibb & ons Inc. of U.S.A. or its subsidiary and associated companies.

The inventionwill be better understood from the following description of an illustrative embodiment, given with reference to the accompanying drawings, in which:~ Figure 7 is a side elevation of one example of a female incontinence device according to the invention; Figure2is atop plan view of the device shown in Figure 1; Figure 3 is a vertical central section taken on the line Ill of Figure 2; and Figure 4 is an end view of the device looking in the direction of IV in Figure 3.

The female incontinence device illustrated in Figures 1-4 is preferably formed, moulded or shaped from a single piece of flexible material. Suitable materials are rubber of a Shore hardness of 50-55 , synthetic rubber, and flexible synthetic plastics materials. The device includes a chamber or basin 10 integral with an outlet pipe 12 and a pairofperipheral deflectable walls 14 and 16. It also has a laterally extending flange 18. This flange serves for connection of the device to a suitable woman's garment, for example a pair of conventional "stretch panties" modified by a cut out in the crutch portion shaped to receive the device.The flange 18 may be stuck or sewn to the panties, to provide a permament attachment, or it may be attached to suitable panties by press-studs or by strips of material having inter-engaging hooks, for example the material known by the Trade Name "VELCRO".

According to an advantageous feature ofthe invention, the periphery of the device intended to contactthe skin ofthe wearer is formed by a pair of deflectable walls defining a groove in which suitable adhesive material of a paste nature may be squeezed. The use of an adhesive or cement or paste is not essential although itis prnferred.Thewalls 14 and 16 are deflectable and are configured so that they deflect inwardly or outwardly into contact with the adjacent surface ofthe body of the wearer: due to this deformation they make surface rather than edge contactwith the body and so tend to provide good sealing without undue discomfort.

As an alternative to this and as an alternative to inserting a paste or cement material between the walls 14and 16, it is possible to insert largely the walls 14, 16 a gasket in the form of a soft deformable ring of thickness chosen to fit snugly between the walls; sealing is then achieved between the upper surface of such a ring,flattened bycontactwiththebodyofthe wearer, and the confronting skin surface of the wearer. The groove 20 is defined by the walls 14 and 16 and as shown may be deeper and narrower at the rear end of the device (right-hand end of Figure 3) and shallower and wider at the forward end ofthe device.

According to another particularly advantageousfeature ofthe device, thewalls 14 and 16 are supported by a portion ofthe material 22 which overhangs a urine receiving chamber 24so defining an undercut region which in use acts to limit splash. In order words, liquid expelled at relatively high pressure runs up the walls of the basin and is turned to move back in a lateral or downward direction. In this way the possibility of any splash reaching the skin of the wearer is greatly reduced.

Another advantageous feature of the invention is designed to improve comfort in wear. The illustrated female incontinence device in accordance with the invention is of "waisted" or "hour glass" shape as seen in plan, as clearly illustrated in Figure 2. The upward facing opening 26 is of like shape, and its boundary is defined by the innerwall 16. As seen in side elevation, the preferred device has a sealing edge of a specially chosen configuration.Each of the two walls 14, has an upperedge34,36which is a complex curve, rising to a high point at the front of the device and another high point at the rear ofthe device, so that the overall configuration is reminiscent ofthat of a saddle. In particularasseen in Figure4,thewalls riseto a rounded cusp or peak which, when the device is worn, is located between the base of the vagina (rearward side) and the anus. In prior artfemal incontinence device, this region has presented problems in obtaining effective and adequate sealing. The "waisted" configuration reffered to has the result that the device is relatively comfortable to wear both in a standing position as well as a sitting position; this comfort is enhanced by the choice of a flexible rubber or rubber-type material for the device.

As can be seen best in Figures 1 and 3, the basin wall 10 defining the lower boundary ofthe chamber 24 is shaped so as to slope sharply away as seen at 28 in the region of outlet pipe 12. The purpose of this is to facilitate quick and unobstructed flowing away of urine into the outlet pipe 12. As shown in Figures 2 and 4, the device may be equipped with a pipe coupling element in accordance with U.K. Patent Application Serial No.2092690.

To the best of Applicants' knowledge and belief, none ofthe extremely numerous attempts to design a satisfactory female incontinence device employed the feature of a pair of deflectable walls defining a groove, none suggested using such a groove to receive a sealant, and the Applicants have moreovertaken special measures in the present design to limit splash back and to renderthe device comfortable to wear. In particular relation to persons liable to discharge urine rapidly at high volume, it is believed that the present incontinence device will prove to be more practical and more satisfactory than prior art designs known to the Applicants.In addition, the device can be easily and cheaply manufactured, as no assembly is involved, and it is relatively simple for a user to apply itto herself particularly when attached to conventional stretch panties, it is also easy to fill the groove 20 with adhesive paste or with a gasketas described and push the incontinence device into position. To the best of Applicants' knowledge and belief,the present device offers numerous advantages which have not been simultaneously achieved by any one of the many hundreds of prior designs of female incontinence device.

CLAIMS (filed on 21/1183) 1. Afemale incontinencedeviceformed principally of a single piece of flexible material which has a pair of deflectable walls which define a channel or groove at the periphery of the device intended to contact the wearer, the device as seen in plan having a "waisted" or approximately "8-shaped" configuration and the deflectable walls as seen in side elevation having sealing edges each of which is constituted by a pair of continuous curves, one on each side ofthe central longitudinal axis ofthe device and which extend from a high pointatthefrontofthe device to a high point at the rear of the device.

2. Adevice according to claim 1 in which the peripheral sealing obtained by the channel or groove defined by two deflectable walls is enhanced by squeezing a liquid-repellanttype of cement or adhesive into the groove, this helps to seal the periphery of the device to the person wearing it.

3. Adeviceaccordingtoclaim 1 inwhichthesaid deflectable walls define a saddle configuration designed to contactthe wearer between the base of the vagina and the anus and located atthe rear zone of the device in orderto minimisethepossibilityofleakage atthis area.

4. A device according to claim 1 or 2 including an undercut region located beneath the deflectable walls intended to limit splash back, and having an overall "waisted" or"8-shaped" configuration as seen in plan to improve comfort in wear.

5. A device according to claim 4which includes a basin or chamber shaped to conduct all urine directly to an outlet pipe.

6. A device according to claim 2 in which the non-irritant cement or adhesive material is a material which can be squeezed from a tube or moulded by hand from a block and which when applied to moist body skin surfaces, is capable of adhesively adhering thereto for a prolonged period of time, for example, well over 12 hours, and which, when so used, does not generate any allergic reaction or irritation in the majority of human beings when so adhered.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (6)

**WARNING** start of CLMS field may overlap end of DESC **. The use of an adhesive or cement or paste is not essential although itis prnferred.Thewalls 14 and 16 are deflectable and are configured so that they deflect inwardly or outwardly into contact with the adjacent surface ofthe body of the wearer: due to this deformation they make surface rather than edge contactwith the body and so tend to provide good sealing without undue discomfort. As an alternative to this and as an alternative to inserting a paste or cement material between the walls 14and 16, it is possible to insert largely the walls 14, 16 a gasket in the form of a soft deformable ring of thickness chosen to fit snugly between the walls; sealing is then achieved between the upper surface of such a ring,flattened bycontactwiththebodyofthe wearer, and the confronting skin surface of the wearer. The groove 20 is defined by the walls 14 and 16 and as shown may be deeper and narrower at the rear end of the device (right-hand end of Figure 3) and shallower and wider at the forward end ofthe device. According to another particularly advantageousfeature ofthe device, thewalls 14 and 16 are supported by a portion ofthe material 22 which overhangs a urine receiving chamber 24so defining an undercut region which in use acts to limit splash. In order words, liquid expelled at relatively high pressure runs up the walls of the basin and is turned to move back in a lateral or downward direction. In this way the possibility of any splash reaching the skin of the wearer is greatly reduced. Another advantageous feature of the invention is designed to improve comfort in wear. The illustrated female incontinence device in accordance with the invention is of "waisted" or "hour glass" shape as seen in plan, as clearly illustrated in Figure 2. The upward facing opening 26 is of like shape, and its boundary is defined by the innerwall 16. As seen in side elevation, the preferred device has a sealing edge of a specially chosen configuration.Each of the two walls 14, has an upperedge34,36which is a complex curve, rising to a high point at the front of the device and another high point at the rear ofthe device, so that the overall configuration is reminiscent ofthat of a saddle. In particularasseen in Figure4,thewalls riseto a rounded cusp or peak which, when the device is worn, is located between the base of the vagina (rearward side) and the anus. In prior artfemal incontinence device, this region has presented problems in obtaining effective and adequate sealing. The "waisted" configuration reffered to has the result that the device is relatively comfortable to wear both in a standing position as well as a sitting position; this comfort is enhanced by the choice of a flexible rubber or rubber-type material for the device. As can be seen best in Figures 1 and 3, the basin wall 10 defining the lower boundary ofthe chamber 24 is shaped so as to slope sharply away as seen at 28 in the region of outlet pipe 12. The purpose of this is to facilitate quick and unobstructed flowing away of urine into the outlet pipe 12. As shown in Figures 2 and 4, the device may be equipped with a pipe coupling element in accordance with U.K. Patent Application Serial No.2092690. To the best of Applicants' knowledge and belief, none ofthe extremely numerous attempts to design a satisfactory female incontinence device employed the feature of a pair of deflectable walls defining a groove, none suggested using such a groove to receive a sealant, and the Applicants have moreovertaken special measures in the present design to limit splash back and to renderthe device comfortable to wear. In particular relation to persons liable to discharge urine rapidly at high volume, it is believed that the present incontinence device will prove to be more practical and more satisfactory than prior art designs known to the Applicants.In addition, the device can be easily and cheaply manufactured, as no assembly is involved, and it is relatively simple for a user to apply itto herself particularly when attached to conventional stretch panties, it is also easy to fill the groove 20 with adhesive paste or with a gasketas described and push the incontinence device into position. To the best of Applicants' knowledge and belief,the present device offers numerous advantages which have not been simultaneously achieved by any one of the many hundreds of prior designs of female incontinence device. CLAIMS (filed on 21/1183)

1. Afemale incontinencedeviceformed principally of a single piece of flexible material which has a pair of deflectable walls which define a channel or groove at the periphery of the device intended to contact the wearer, the device as seen in plan having a "waisted" or approximately "8-shaped" configuration and the deflectable walls as seen in side elevation having sealing edges each of which is constituted by a pair of continuous curves, one on each side ofthe central longitudinal axis ofthe device and which extend from a high pointatthefrontofthe device to a high point at the rear of the device.

2. Adevice according to claim 1 in which the peripheral sealing obtained by the channel or groove defined by two deflectable walls is enhanced by squeezing a liquid-repellanttype of cement or adhesive into the groove, this helps to seal the periphery of the device to the person wearing it.

3. Adeviceaccordingtoclaim 1 inwhichthesaid deflectable walls define a saddle configuration designed to contactthe wearer between the base of the vagina and the anus and located atthe rear zone of the device in orderto minimisethepossibilityofleakage atthis area.

4. A device according to claim 1 or 2 including an undercut region located beneath the deflectable walls intended to limit splash back, and having an overall "waisted" or"8-shaped" configuration as seen in plan to improve comfort in wear.

5. A device according to claim 4which includes a basin or chamber shaped to conduct all urine directly to an outlet pipe.

6. A device according to claim 2 in which the non-irritant cement or adhesive material is a material which can be squeezed from a tube or moulded by hand from a block and which when applied to moist body skin surfaces, is capable of adhesively adhering thereto for a prolonged period of time, for example, well over 12 hours, and which, when so used, does not generate any allergic reaction or irritation in the majority of human beings when so adhered.