WO1999018898A1

WO1999018898A1 - An external female urine collection device and a method for manufacturing such a device

Info

Publication number: WO1999018898A1
Application number: PCT/DK1998/000381
Authority: WO
Inventors: Morten Bay Alexandersen; Kristian Sloth
Original assignee: Coloplast A/S
Priority date: 1997-10-09
Filing date: 1998-09-08
Publication date: 1999-04-22
Also published as: AU9062298A

Abstract

An external female urine collection device comprises a flexible conduit (1) having an inlet end (2) arranged in liquid flow communication with the urethral opening (3), and at least one support member (4) sealingly surrounding the conduit inlet end (2). A first side (5) of the at least one support member is arranged in sealing contact with the skin tissue of the female vulva area (6). The inlet end (2) of the conduit (1) has and internal diameter exceeding the diameter of the urethral opening (3) and the support member (4) is generally disc-shaped and formed entirely from a tacky sealing compound which is easily deformable by manipulation for moulding into mating contact with the vulva area (6).

Description

TITLE

An external female urine collection device and a method for manufacturing such a device.

FIELD OF THE INVENTION The present invention relates to an external female urine collection device of the kind comprising a flexible conduit for conducting urine away from the urethral opening towards a disposal or collection assembly. The conduit has an inlet with an internal diameter exceeding the diameter of the urethral opening and the inlet is arranged in alignment with the urethral opening. The collection device compri- ses at least one support member sealingly surrounding said inlet end and said at least one support member has at least one inner surface provided with an adhesive sealing forming a sealing contact with the female vulva area surrounding the urethral opening and at least one outer surface facing away from said vulva area.

BACKGROUND OF THE INVENTION

Urinary incontinence is a frequently occurring problem for human individuals, in particular in the adult female population. Various forms of incontinence are suffered either permanently by disabled individuals, who may be wheelchair bound as a result of an accident or disease, or temporarily either short term after certain operations or childbirth or for extended periods because of changes during menopause or other factors inherent in the ageing process.

A multitude of different products have been suggested or are available on the market to remedy or compensate for the discomfort caused by urinary incontinence. Typical products for use by female individuals are absorbing articles fre- quently used in cases of long term incontinence, plug-like members for insertion into the female urethra, pressure devices for use in the vagina and catheters which are typically used by paraplegic or tetraplegic patients. The majority of known products or articles suffer from significant practical disadvantages. Thus, absorbing products in the form of sanitary towels and pads are inconvenient and cumbersome in use and may often cause skin irritation like maceration or fungal diseases. Devices intended for insertion into the vagina are li- mited to use mainly in cases of light incontinence. Many devices requiring insertion of a foreign member into the urethra involves a high risk of infection.

External collecting devices of the kind to which the invention pertains do not generally cause infection and due to the fact that urine is transported away from the urethral opening and the vulva area they also carry a significantly reduced risk of fungal disease.

A general problem with external collecting devices for use by female individuals is related to the connection of the device to the female body. The majority of available known solutions are quite complex and in general not discrete. Moreover, they often comprise rather rigid structures resulting in considerable discomfort.

The prior art device known from DE patent application no. 28 17 571 comprises a tube portion (D) carrying a flange (B) which flange (B) is made by the same di- mensionally stable material as the tube portion (D) and covered with a sealing ring (E) made of a gelatinous material.

This prior art, together with most other known solutions, are not usable by wheelchair bound individuals, as they do not function with a sitting person because of compression of wall parts of the product, blocking of the outlet, through which urine is to be transported away, or a risk of pressure sore caused by the complex structure of such products.

Many prior art devices of this kind such as disclosed e.g. in US-A-3,900,019, US-A-5,387,205 and US-A-5, 511 ,557 are, moreover, only intended for collection of urine samples and not for prolonged use. Known devices intended for prolonged use are often provided with some kind of a fixation member engaging the vagina, either just wall parts at the vaginal opening or by deeper penetration into the vagina. As an example, US-A-4,023,560 discloses a female urinary device including an inverted U-shaped member which is stiff and resiliently bendable and has an upper end portion insertable into the vaginal orifice and depending spaced leg portions engaged with the vaginal wall. Obviously, such a device relying on engagement within the vagina is not ideal for use in a sitting position in which a large part of the body weight will be acting on the device.

Other prior art devices include waist belts or harnesses which by themselves entail a great deal of discomfort in use.

Other known urine collection systems are provided with a strong adhesive layer for fixation with respect to the body, similar to the adhesives used for ostomy devices, or they may comprise a strong adhesive paste applied to the device to en- sure a leakage free contact with the body. A commercially available product of this kind is marketed under the registered trade mark "InCare".

In US-A-4, 198,979 a female urine collection device is disclosed comprising a generally funnel-shaped and rigid one-piece collection member with a wide orifice and having on its upper side a flanged lip forming a seat to which a sealant com- posed of layer of a double adhesive is applied. The upper surface, to which the sealant is applied, is shaped to fit within the contour of the perineum area with the urethral opening aligned with the wide orifice, the sealant being in contact with the vestibular tissue to prevent leakage of urine.

The adhesive used in this prior art device has the disadvantage that the area of the skin to which the adhesive is applied need to be shaved to prevent hair from being torn out upon removal of the device. In view of its extreme sensitivity the skin at this area is not suitable for being shaved almost daily. This applies, in particular to individuals in southern countries, where the risk for skin diseases like barber's itch is increased due to warmth and humidity and people are often more hairy The problem with skin sensitivity is even more pronounced for disabled persons like paraly- tics

An external female urine collection device of the kind defined in the foregoing is disclosed in EP-A-286 752 Such a device can be worn for extended periods to avoid or reduce the need for cathenzation, whereby transurethral transport of microorganisms is avoided or minimized The conduit of this known device has an internal diameter essentially equal to the diameter of the urethra and is arranged with the conduit in axial alignment with the urethral opening by means of a movable positioning member The inlet of the conduit is circumferentially encompassed by and affixed to a support member, to which a pliable adhesive sealing medium is applied, by means of which the support member can be secured in leak- free relationship with the vulva area with the conduit aligned with the urethral ostium without any part of the conduit itself penetrating into the urethra Thereby, urine can flow freely from the urethral ostium through the conduit to the collection and storage zone

This prior art collection device is intended, in particular, for users in a lying position and for employment by normal active females, particularly in a gravity-free en- vironment such as outer space conditions It is not ideal, however, for users in a sitting position Moreover, the need of using a special positioning member will make this product unsuitable for use by paralytics who often also suffer from poor dexterity In addition, the fact that the positioning member penetrates shortly into the urethra entails a certain increased infection risk

BRIEF DESCRIPTION OF THE INVENTION

On the background of this prior art, it is the object of the invention to provide an improved female urine collection device which overcomes the disadvantages and shortcomings mentioned above to provide a female incontinence aid having a significantly increased comfort in use and optimum functionality regardless of the position of the user so as to be particularly suitable for users in a sitting position such as wheelchair bound individuals

According to the invention this and other objects of the invention is accomplished by a female urine collection device of the kind set forth which is characterised in that at least one support member is generally discshaped and formed from a tacky sealing compound which is easily deformable by manipulation for moulding into mating contact with said vulva area surrounding the urethral opening

In use, the support member of the urine collection device of the invention can be easily arranged by the user with the inner surface in adhesive contact with the tissue at the vulva area surrounding the urethral opening Due to the internal diameter of the conduit inlet being larger than the diameter of the urethral opening the device can, on one hand, be quite easily positioned in alignment with the urethral opening without use of a separate positioning member to be inserted into the urethra and, on the other hand, the device is perfectly capable to receive the relatively high urination flow rate with female users The supporting member is easily mouldable into mating contact with the vulva area and is kept safely in position by the adhesive sealing which, however, is sufficiently faint to allow easy detachment of the device The supporting member is so to speak modelled into position by the user

Thus, in one preferred embodiment the ability of the device to receive the relatively high urination flow rate with female individuals is improved by placing a buffer chamber formed by an enlargement of the conduit at the inlet end of the conduit preferably immidiately after the urine has entered the conduit, whereby the walls of the conduit will not produce any counter pressure to the flow of urine through the device

In a further preferred embodiment, the easy manipulation of the support member by the user is further assisted by covering the outer surface of the deformably support member with a protective layer formed from a thin, flexible and skin-friendly foil material This covering, which can be extended to all surface parts of the deformable support member outside the part of the inner surface of the member to be positioned in adhesively sealing contact with the vulva area tissue, can be made of a foil material such as a polyurethane-based material giving the covered surface parts of the support member a surface character different from the surrounding skin tissue, thereby assisting the user with respect to localisation of the device when it is to be detached for removal

In a still further preferred embodiment, the manipulation of the supporting member by a user such as a tetraplegic having poor dexterity may be further assisted by profiling the second side of the support member to increase mouldability and flexibility of the support member and provide a gripping surface to facilitate said manipulation The profiling can typically be in the form of discrete raised projections separated by tracks or grooves By such a profiling of the support member manipulation of the support member for arrangement of the collecting device can be performed also by users having an extremely poor dexterity of the fingers

The external urine collection device according to the invention is intended for use together with a disposal or collection assembly such as a urine bag which via a hose may be connected with the conduit of the collection device Both the collection device as such and the whole incontinence system comprising the collection device and the disposal or collection assembly including any hose connection may be designed for disposable or multiple use

The invention also relates to a method of manufacturing the above-mentioned preferred embodiment of the female urine collection device according to the invention, in which the outer surface of the deformable support member is covered with a protective layer This method is characterized in that the support member is made by solidifying said tacky sealing compound in a mould lined with said foil material in which said conduit is arranged as a core member This method is also well suited for manufacture of the further preferred embodiment in which the second side of the support member is profiled by using a mould wall parts of which are profiled to provide profiling to the second side of the support member

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be further explained with reference to the accompanying drawings, in which

figure 1 illustrates a urine collection device embodying the invention arranged in position against the vulva area of a female user,

figure 2 is an enlarged presentation of the collection device shown in figure 1 ,

figures 3 and 4 are a plan view and a cross-sectional view, respectively, of a preferred embodiment of the urine collection device of the invention;

figure 5 is a schematical illustration of the embodiment in figures 3 and 4 arranged in the position of use,

figures 6 and 7 show a further embodiment of the urine collection device and its arrangement in the position of use;

figure 8 shows an advantageous modification of the design of the conduit of the collecting device of the invention; and

figure 9 is a schematical illustration of a mould suitable for manufacture of the urine collection device of the invention; and

figure 10 shows a further embodiment of the urine collection device comprising two support members. DETAILED DESCRIPTION OF THE INVENTION

As shown in figures 1 and 2 an external female urine collection device according to the invention comprises a conduit 1 , which may be formed as a relatively short hose part of a flexible plastic and has an inlet end 2 arranged in alignment and liquid flow communication with the opening of the female urethra 3 The inlet end 2 of conduit 1 is provided with reinforcement means 2a, e g by being designed with an increased wall thickness, and is surrounded by and sealingly connected with a deformable support member 4 having an inner surface 5 arranged in sealing contact with the skin tissue of the vulva area 6 which surrounds the opening of the urethra 3 and is defined by the labia majora 7

According to the invention, the inlet end 2 of the conduit 1 has an internal diameter which exceeds the opening diameter of the urethra 3 Typically the inlet end diameter of the conduit 1 may be between 10 and 20 mm Thereby, the advantage is obtained that the device can normally be arranged in the position of use even by a disabled user having poor dexterity without the use of a separate positioning member However, since the arrangement of the device by a disabled user will often be performed following an intermittent catheπzation of the bladder the device may optionally be arranged with its conduit in alignment with the urethral opening by using the urinary catheter employed for the intermittent ca- thenzation as a positioning member

The larger diameter of the inlet end 2 of the conduit 1 entails the further advantage that the device will be perfectly capable of taking-up the relatively high urination flow rate from a female user without any leak of urine between the support member and the vulva area of the user

As shown in figure 8 this advantage can be further improved by forming the conduit 1a with an enlargement forming a buffer chamber 31 between the inlet end 2 of conduit 1 and the outer surface of the deformable support member 4 facing away from the inlet end 2 The support member 4 is generally made in the form of a relatively flat disc and is formed entirely from a tacky sealing compound, which can be easily deformed by manipulation so that it can be moulded into mating contact with the skin tissue of the vulva area 6. Thereby, the urine collection device can be quite easily posi- tioned by the user to provide a substantially leak-free urine flow from the bladder 8 through the urethra 3 and the conduit 1 to a disposal or collecting device, not illustrated, which in a manner known per se may be connected to an outlet end 9 of the conduit 1.

The deformable support member 4 is preferably manufactured by solidification of a 2-component silicone composition based on polydimethylsiloxanes and incorporating a first component A containing a polymer, an inhibitor and a catalyst and a second component B containing a polymer, an extender and a crosslinker mixed in a suitable ratio to provide optimum characteristics for obtaining the desired product structure and performance. In general, compositions comprising a greater quantity of the second component B than of the first component A will tend to be less tacky and flexible, whereas compositions containing a larger quantity of the first component A will be softer and more tacky and flexible to achieve the desired mouldability.

For the purpose of the present invention the mixing ratio of the first component A to the second component B may suitably be within the range from 1 : 0.9 to 1 : 1.1 and preferably 1 : 0.95. Thereby the first side 5 of support 4 will acquire a sufficiently adhesive or tacky character to retain the collection device in the position of use for extended periods, while at the same time allowing easy detachment without discomfort to the normally very sensitive skin tissue at the vulva area 6. For users having reduced skin sensibility at the vulva area the described composition of the compound for the support member 4 offers a considerable practical advantage with respect to a significantly reduced risk of pressure sores. The support member may alternatively be made, however, of other compound materials such as hydrogel materials affording the desired tacky sealing characteristics

As further illustrated in figure 2 a outer side 10 of the deformable support mem- ber 4 is preferably covered with a protective layer 1 1 formed by a thin, flexible and skin-friendly foil material, which may suitable be a polyurethane-based material Thereby, the second side 10, which is to be manipulated by the user when arranging the collection device in the position of use shown in figure 1 , will be given a surface character easily distinguishable from the surrounding skin tissue, e g at the labia majora in addition to facilitating the user's manipulation of the support member when arranging the collection device, the distinct surface character of the protective layer also assist the user in localizing the collection device when it is desired to remove it

In the plan view in figure 3 and the cross-sectional view in figure 4 taken along lines IV - IV in figure 3 a further preferred embodiment of the deformable support member 4a is shown, in which the outer surface 10a is provided with a profiling, suitably in the form of discrete raised projections 12, separated by tracks or grooves 13 Thereby, the mouldability and flexibility of the support member 4 will be improved and the outer surface 10a will provide a gripping surface that will signi- ficantly assist the user both in manipulating or modelling the support member when arranging the collection device in the position of use shown in figure 4 and in localizing the device when it is desired to remove it

In the same way as for the embodiment in figures 1 and 2 the outer surface 10a of the support member 4a shown in figures 3 and 4 may be covered by a protec- tive layer 11a

As illustrated in the plan views in figures 3 and 6 the collection device of the invention may suitably be supplied with a deformable support member 4b having a generally elliptical circumferential contour 14 as shown in solid lines With the illustrated size of the support member 4b this will usually entail that the vaginal opening 15 as shown in figure 6 will be covered by the support member 4b

In order to allow use of the collection device in situations, such as menstruation periods, where there is a need for an unobstructed flow passage from the vaginal opening the deformable support member 4b may as shown in dashed lines in figure 6 be provided with marking lines 16 allowing the user to cut-out the part 17 of the support member which would otherwise obstruct the vaginal opening 15

As further illustrated in figure 6 the deformable support member 4b may be provided with additional marking lines 18 to allowing shaping of edge parts 19 and 20 of the support member which in the position of use are facing the thighs of the user, thereby improving the comfort in use of the collection device

As an alternative to forming the support member with marking lines 16 and 18 as shown in figure 6, the device may be supplied with a support member preformed into a circumferential contour following marking lines 16 and/or 18

As a further possibility to increase the comfort for the user the circumferential edge of the support member may be rounded or bevelled as shown in figures 2 and 4

The embodiments of the collection device shown in figures 2 to 8 may as illustrated in figure 9 be manufactured by solidification of the tacky sealing silicone com- pound, from which the support member 21 is to be made in a mould 22, which is lined with the foil material 23 serving to provide the protective covering on the second side 24 of support member 21 , and in which a hose member 25 intended to form the conduit of the collection device is arranged to penetrate the foil material 23 and supported as a core member by arrangement in a bore 26 through the bottom of the mould 22 For manufacture of the preferred embodiment shown in figures 3 and 4 the inner side of the bottom of the mould 22 may be profiled to form the profiling of the second side of the support member

The embodiment of the collection device shown in figure 10 is constituted by two support members 4c and 4d The inner support member 4c is provided with an inner surface 5c which forms a sealing contact with the mucous membrane surrounding the urethral opening in the female vulva area 6 Preferably the inner support member 4c should be placed between the labia minora of the user but the actual placing depends on the anatomy of the user The outer surface 10c of the inner support member 4c should be more or less covered by the users labia majora The support member is provided with a backward pointing part 32 which should cover the lowest front part of the wall of the vagina and provide a sealing contact preventing leakage of urine

The outer support member 4d is provided with an inner surface 5d which forms an adhesive contact with the skin of the user and this adhesive will retain the collection device in the wanted position for extended periods The outer support member is formed entirely from a tacky sealing compound which is easily deformable by manipulation

The outer support member 4d is connected to the inner support member 4c by a deformable connection 33 which is sealingly fastened to the conduit 1 The connection 33 is made of a relatively soft elastic plastic or rubber material such as silicone, polyurethane, polystyrene based block copolymers or latex The connection 33 can be formed as a corrugated hull which allows extending of the connection 33 Openings 34 in the conduit 1 might lead leaked urine caught between the two support members 4c and 4d into the conduit 1

Claims

1 An external female urine collection device of the kind comprising a flexible conduit for conducting urine away from the urethral opening towards a disposal or collection assembly, said conduit having an inlet with an internal diameter ex- ceeding the diameter of the urethral opening and arranged in alignment with the urethral opening, and at least one support member sealingly surrounding said inlet end, said at least one support member having at least one inner surface provided with an adhesive sealing forming a sealing contact with the female vulva area surrounding the urethral opening and at least one outer surface facing away from said vulva area, characterized in that at least one support member (4, 4a, 4b, 4d) is generally discshaped and formed from a tacky sealing compound which is easily deformable by manipulation for moulding into mating contact with said vulva area (6) surrounding the urethral opening (3).

2. A female urine collection device as claimed in claim 1, characterized in that the device comprises at least two support members (4c,4d), where a first support member (4c) is formed from a relatively thin plate of material having an inner surface (5c) provided with an adhesive sealing forming a sealing contact with the mucous membrane surrounding the urethral opening (3) in the female vulva area (6), and a second support member (4d) formed from a generally discshaped tacky sealing compound which is easily deformable by manipulation for moulding into mating contact with the skin tissue of the vulva area mainly defined by the labia majora of the user.

3. A female urine collection device as claimed in claim 2, characterized in that the first support member (4c) has a part (32) forming sealing contact with the mucous membrane of the lowest part of the front wall of the vagina.

4. A female urine collection device as claimed in claim 3, characterized in that the tacky sealing compound is a gel-like silicone compound and that the silicone compound preferably is made from a 2-component silicone system.

5. A female urine collection device as claimed in claim 4, characterized in that said silicone system is based on polydimethylsiloxanes and comprises a first component (A) containing a polymer, an inhibitor and a catalyst and a second component (B) containing a polymer, an extender and a crosslinker, said first

5 and second components being mixed in a ratio within the range 1:0.9 to 1:1.1, preferably a ratio of 1 :0.95.

6. A female urine collection device as claimed in any of the preceding claims, c h a racterized in that the outer surface (10, 10a) of the support member (4, 4a) formed from a tacky sealing compound is covered with a protective layer (11 ,

1011a) formed from a thin, flexible and skin-friendly foil material.

7. A female urine collection device as claimed in claim 6, characterized in that said foil material is a polyurethane-based material.

8. A female urine collection device as claimed in any of the preceding claims, c h aracterizedin that the outer surface (10a) of the support member (4a) for-

15 med from a tacky sealing compound is profiled to increase mouldability and flexibility of the support member and provide a gripping surface to facilitate said manipulation.

9. A female urine collection device as claimed in claim 9, characterized in that the profiling of the outer surface (10a) is in the form of discrete raised projec- 0 tions (12) separated by tracks or grooves (13).

10. A female urine collection device as claimed in claim 11, characterized in that said support member (4b) formed from a tacky sealing compound is provided with marking lines (16, 18) to allow removal of a cut-out parts (17, 19, 20) of the member to uncover the vaginal opening (15) or for adapting the contour of 5 said member to the thighs of the user.

11. A female urine collection device as claimed in claim 11, characterized in that the support member (4b) is preformed with a cut-out part to uncover the vaginal opening or with circumferential edge parts shaped to adapt the contour of the support member to the thighs of the user.

512. A female urine collection device as claimed in any of the preceding claims, c ha racterizedin that the circumferential edge of said support member is rounded or bevelled.

13. A female urine collection device as claimed in any of the preceding claims, c ha racterizedin that said conduit (1) is provide with reinforcement means 0 (2a) at said inlet end (2).

14. A method of manufacturing a female urine collection device as claimed in claim 7 or 8, characterized in that the support member (21 ) formed from tacky sealing material is made by solidifying said tacky sealing compound in a mould (22) lined with said foil material (23) in which said conduit (25) is arranged to penetrate said foil material (23) and is supported as a core member by a wall part of said mould.

15. A method as claimed in claim 18 for manufacturing a female urine collection device as claimed in claim 9 or 10, characterized in that wall parts (26) of said mould (22) are profiled to provide profiling to said second side (24) of said support member (21).