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FLUID DISCHARGING OR COLLECTION DEVICE FIELD OF THE INVENTION

The present invention relates to a device for discharging or collection fluid from a body. More particularly but not exclusively it relates to a device for discharging or collecting fluid reliant on a locator that engages with the fluid discharging or collection point.

It is an object of the present invention to provide a device for discharging or collection fluid that overcomes or at least ameliorates some of the abovementioned disadvantages or which at least provides the public with a useful choice. Other objects of the invention may become apparent from the following description which is given by way of example only.

SUMMARY OF THE INVENTION

Broadly stated, the invention relates to a tube-like device for sealing against a fluid opening, the device comprising a locator element that extends substantially transverse to the walls of the tube-like device, with an aperture therein to allow fluid flow, having (a) an inner region that extends from about the wall of the tube-like device head towards the centre of the tube-like device and (b) an outer region, that extends radially outwards from the wall of the tube-like device,

such that positioning of the locator element by the user against a fluid opening actuates the locator element through deflection of the inner region away from the user and simultaneous deflection of the outer region towards the fluid opening to form a seal.

Another aspect of the invention relates to a device for discharging or collecting fluid, the device comprising:

(A) a tube-like engagement head having a fluid receivable end for engaging the mouth of the fluid outlet and a fluid discharge end, the tube-like engagement head comprising

(i) a locator element, located at the fluid receivable end of the engagement head that allows the fluid from to access the fluid discharge end of the engagement head, the locator element extending substantially transverse to the walls of the tube-like engagement head to define (a) an inner locator element region that extends from about the wall of the tube-like engagement head towards the centre of the tube-like engagement head, and (b) an outer locator element region, that extends radially outwards from the wall of the tube-like engagement head, and (ii) a conformable material attached to, or formed unitarily with, the

locator element,

such that positioning of the locator element by the user against the fluid oudet actuates the locator element to move into a substantially sealing configuration about the fluid oudet.

In some embodiments the positioning of the locator element against the fluid oudet by the user actuates the inner locator element such that the outer locator element moves towards a substantially fluid oudet sealing configuration.

In some embodiments the inner locator element is deflected inward of the tube-like engagement head such that the outer locator elemerit is simultaneously deflected or moved towards or about the fluid oudet or into a substantially sealing configuration.

In some embodiments, when in use, positioning of the locator element against the fluid oudet causes the locator element to act as a fulcrum as the fluid oudet pushes against the inner region causing the outer region to move towards the fluid outiet, resulting in a seal being formed between the user and the fluid oudet surround.

Another aspect of the invention relates to a device for discharging or collecting fluid, the device comprising

an engagement head that engages the fluid receivable end of the ducting apparatus, wherein the engagement head includes an annular seal member about an entrance of the engagement head, which entrance can allow fluid to the ducting apparatus, and

wherein variation of the disposition of the ducting apparatus to at least part of the engagement head or to the annular seal, or both, can create a couple on the annular section thereby to vary conformation of the annular seal member to the fluid oudet.

Another aspect of the invention relates to a device for discharging or collecting fluid, the device comprising

a first annular seal located about the fluid receivable end of the duct, the first annular seal adapted to seal against the fluid oudet,

a second annular seal located radially outwards of the first annular shield, the second annular shield adapted to seal against the user. Another aspect of the invention relates to an urinary aid able to be positioned by a female user to allow that female user to urinate with control, the device comprising:

(B) a tube-like engagement head having a urine receivable end for engaging the mouth of the urethra and a urine discharge end, the tube-like engagement head comprising

(i) a locator element, located at the urine receivable end of the engagement head that allows urine from the female to access the urine discharge end of the engagement head, the locator element extending

substantially transverse to the walls of the tube-like engagement head to define (a) an inner locator element region that extends from about the wall of the tube-like engagement head towards the centre of the tubelike engagement head, and (b) an outer locator element region, that extends radially outwards from the wall of the tube-like engagement head, and

(ii) a conformable material attached to, or formed unitarily with, the

locator element,

such that positioning of the locator element by the user against the urethral opening actuates the locator element to move into a substantially sealing configuration about the users urethral opening.

In some embodiments the positioning of the locator element against the urethral opening by the user actuates the inner locator element such that the outer locator element moves towards a substantially urethral opening sealing configuration.

In some embodiments the inner locator element is deflected inward of the tube-like engagement head such that the outer locator element is simultaneously deflected or moved towards or about the urethral opening of the user or into a substantially sealing

configuration.

In some embodiments, when in use, positioning of the locator element against the urethral opening causes the locator element to act as a fulcrum as the urethral opening pushes against the inner region causing the outer region to move towards the female user, resulting in a seal being formed between the user and the urinary aid.

Another aspect of the invention relates to an urinary aid able to be positioned by a female user to assist that female to urinate with control, the device comprising an engagement head that engages the urine receivable end of the ducting apparatus, wherein the engagement head includes an annular seal member about an entrance of the engagement head, which entrance can allow urine to the ducting apparatus, and

wherein variation of the disposition of the ducting apparatus to at least part of the engagement head or to the annular seal, or both, can create a couple on the annular section thereby to vary conformation of the annular seal member to that female.

Another aspect of the invention relates to an urinary aid able to be positioned by a female user to assist that female to urinate with control, the device comprising

a first annular seal located about the urine receivable end of the duct, the first annular seal adapted to seal against the urethra and be contained within the labia minora, a second annular seal located radially outwards of the first annular shield, the second annular shield adapted to seal against the user, and be contained within the labia minora.

The following embodiments may relate to any of the above aspects.

In some embodiments the discharge/ collection device is applied to the urethral opening, an incision, a body orifice or the like.

In some embodiments the discharge/collection device is formed with a duct, or the duct is applied to the device just prior to use.

In some embodiments the ducting is attached to the discharge /collection device just prior to use. Another aspect of the invention relates to a pack of discharge/collection devices of" the present invention, with or without the ducting.

In some embodiments the duct is a flexible hose. Preferably the duct includes an expanding concertina arrangement, or bellows that provide for its bendability.

In some embodiments the duct is telescopic. In some embodiments the locator element is a contoured circular seal adapted to form a seal when pressed around the mouth of fluid oudet (i.e. urethral opening).

In some embodiments the locator element self aligns to the mouth of the fluid oudet to form the seal. Preferably the locator element is moveable to facilitate the sealing of the locator element to the fluid oudet. In some embodiments the conformable material is present as a layer of soft absorbent material on at least part of the locator element. Preferably the conformable material is present on that part of the locator element that forms a seal against the body.

In an alternate embodiment the conformable material is present about the locator element.

In some embodiments the locator element and the conformable material are formed from a single material. Preferably the material for the conformable material remains soft while the material for the locator element is compressed so as to have an increased rigidity compared to the conformable material. In an alternate embodiment the locator element and the conformable material are formed from two or more different materials, joined to each other by gluing, heat adhering, stitching, or any other method for attaching a soft and absorbable material to a more rigid material.

In some embodiment the seal between the body and the discharge/ collection device is facilitated by hydration of one or both of the locator element or the conformable material.

In some embodiments the discharge/collection device comprises one or more sealing rings radially outwards of the locator element.

In some embodiments the discharge/collection device comprises an exterior shell. Preferably the shell is formed from a plastic or a rigid paperboard material. Preferably the shell is biodegradable.

In some embodiments the locator element and/or conformable material are coated or imbibed with a lubricant, an anti-bacterial or a perfume, scent or antifungal or a combination thereof.

In some embodiments at least part thereof of the discharge/collection device is biodegradable. Preferably the locator element is biodegradable. Preferably the locator element and the conformable material are both biodegradable. Preferably the locator element, the conformable material and the duct are all biodegradable. Preferably the conformable material is biodegradable. Preferably the conformable material and the duct are both biodegradable. More preferably the entire discharge/ collection device is biodegradable. In some embodiments the locator element is formed, at least in part by, wood pulp, tissue, polyacrylate polymers, absorbing fabric, absorbing paper, gelatine, starch, cellulose, alginate or carageenan, or a combination thereof.

In some embodiments the absorbable material is formed, at least in part by, wood pulp, tissue, polyacrylate polymers, absorbing fabric, absorbing paper, gelatine, starch, cellulose, alginate or carageenan, or a combination thereof.

In some embodiments the duct comprises a one way valve. Preferably the valve opens in response to the collection of a small amount of urine. More preferably the valve only opens when about 0.1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, or 50 ml of fluid is accumulated.

In some embodiments the engagement head is 10, 15, 20, 25, 30, 35, 40, 45 and 50 millimetres in diameter. More preferably the engagement head is about 25 rnillimetres in diameter.

In some embodiments the discharge/ collection device comprises an air excluder, aperture or inlet to allow air flow between the environment and the internal ducting of the discharge/collection device so that when in use (and the aid is sealed against the user) air can pass out/in of the device (without needing to pass through the distal opening of the duct) to avoid a vacuum forming.

In some embodiments the discharge/ collection device is positioned against a fluid outlet. Preferably the discharge/ collection device is applied against the urethral opening, and more preferably against the urethral meatus.

Another aspect of the invention relates to a method of making an

discharge/ collection device of the present invention comprising the steps (in _. no particular order) of:

forming the locater element, wherein the locator element is adapted to seal about the fluid outlet,

forming the absorbable material on or about the locator element,

attaching a duct to the locator element and absorbable material pair,

such that when in use the fluid passes from the fluid outlet past the locator element and into the duct. Another aspect of the invention relates to a method of making an urinary aid of the present invention comprising the steps (in no particular order) of:

forming the locater element, wherein the locator element is adapted to seal about the mouth of the urethra,

forming the absorbable material on or about the locator element,

attaching a duct to the locator element and absorbable material pair,

such that when in use the urine passes from the urethra past the locator element and into the duct.

In some embodiments the locator element is formed unitarily with the absorbable material. Preferably the locator element material is compressed to form it as a rigid material. More preferably the locator element and absorbable material are compression moulded, with the locator element material having greater compression (and thus increased density) compared to the absorbable material.

In an alternate embodiment the locator element and the absorbable material are formed from separate materials. Preferable the locator element and the absorbable material are bonded to each other. In one embodiment the locator element and the absorbable material are heat moulded together, the heat moulding bonding the two materials together.

In one embodiment the method of forming the discharge/ collection device comprises the step of forming the device into a lie flat blank, wherein the lie flat blank can be inflated or pulled into its 3-dimensional operational state.

In one embodiment the discharge/ collection device is packaged in a compressed condition. Preferable the compressed urinary aid is bias to reform to its 3-dimensional condition.

Another aspect of the invention relates to a method of using a

discharge /collection device comprising the steps of

1. obtaining an discharge/ collection device that comprises

(a) a duct having a fluid receivable end a fluid discharging end,

(b) a locator element, located at the fluid receivable end of the duct that allows fluid from the fluid outlet to access the duct, that effectively extends substantially transverse to the duct to define (a) an inner locator element region that extends from about the wall of the duct towards the notional centre of the duct, and (b) an outer locator element region, that extends away radially outwards from the wall of the duct, and

(c) a conformable and absorbable material ("conformable material")

attached or formed unitarily with the locator element,

2. wherein the discharge/ collection device is applied to the fluid oudet so that the locator element forms a seal substantially about the fluid outlet.

Another aspect of the invention relates to a method of using an urinary aid

comprising the steps of

2. obtaining an urinary aid that comprises

(a) a duct having a urine receivable end a urine discharging end,

(b) a locator element, located at the urine receivable end of the duct that allows urine from the female to access the duct, that effectively extends substantially transverse to the duct to define (a) an inner locator element region that extends from about the wall of the duct towards the notional centre of the duct, and (b) an outer locator element region, that extends away radially outwards from the wall of the duct, and

(c) a conformable and absorbable material ("conformable material")

attached or formed unitarily with the locator element,

3. wherein the female user applies the device to the mouth of her urethra so that the locator element forms a seal substantially about the urethral mouth, such that the locator element is positioned within the confounds of the labia minora.

In some embodiments the use of the device includes the step of pressing the discharge/ collection device against the fluid outlet so that the conformable material, located about the locator element, pushes forward in a fulcrum motion so that the conformable material forms a seal against the fluid oudet.

When applied against the urethral opening, preferably the seal is formed within the confounds of the labia minora.

In one embodiment after use, the discharge/ collection device is rotated slighdy such that the conformable material can absorb any fluid that has escaped the seal between the locator element and the user. This also aids as a wipe. Another aspect of the invention relates to the use of a discharge/ collection device of the present invention.

Another aspect of the invention relates to the use of an urinary aid of the present invention. Another aspect of the invention relates to a discharge/ collection device substantially described, with or without reference to any one or more of the accompanying drawings.

Another aspect of the in% ^r ention relates to an urinary aid substantially described, with or without reference to any one or more of the accompanying drawings.

Other aspects of the invention may become apparent from the following description which is given by way of example only and with reference to the accompanying drawings.

As used herein the term "conformable" includes the ability to adopt a shape complementary to the object to which it is being applied.

As used herein the term "biodegradable" means that the material will decompose or break down when exposed to the environment. In some embodiments, the biodegradation occurs within two weeks, three weeks, one month, one, two, three, four, five, six, seven, eight, nine, ten, eleven or twelve months. More preferably, the biodegradation does not require any active steps on behalf of the user, the device fully breaking down when or after being disposed.

As used herein the term "and/ or" means "and" or "or", or both. As used herein "(s)" following a noun means the plural and/ or singular forms of the noun.

The term "comprising" as used in this specification and claims means "consisting at least in part of. When interpreting statements in this specification and claims which include that term, the features, prefaced by that term in each statement, all need to be present but other features can also be present. Related terms such as "comprise" and "comprised" are to be interpreted in the same manner.

To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by way of example only and with reference to the drawings in which:

Figure 1 is a section view through AA of Figure 3C of a discharge/ collection device of the present invention having the locator element adapted to seal against the fluid oudet,

Figure 2 is a section view through AA of Figure 3C showing the fulcrum like movement of the locator element of a discharge/collection device of Figure 1,

Figure 3A is a section view through AA of Figure 3C showing the locator element adapted to seal against the fluid oudet,

Figure 3B is a section view through AA of Figure 3C showing the locator element adapted to seal against the fluid oudet with a layer of conformable material that forms a layer between the locator element and the body,

Figure 3C is an end view of the locator element and conformable material of an embodiment of the invention whereby the conformable material surrounds the locator element,

Figure 4 shows a side view of a duct,

Figure 5 shows a perspective view of an alternate embodiment of the invention, showing a discharge/ collection device with multiple annular seals,

Figure 6 shows a cross-section view of a discharge/ collection device of Figure 5 with the duct attached,

Figure 7 shows a cross-section view of a discharge/ collection device of Figure 5 without the duct attached,

Figure 8A shows an end view of a discharge/collection device of Figure 5,

Figure 8B shows an end view of a discharge/collection device of Figure 5,

Figure 9 shows a cross-section view through BB of Figure 12B,

Figures 10A and 10B show a end and side view of a discharge /collection device of

Figure 8,

Figure 11A shows a locator element of a discharge/ collection device of Figure 8,

Figure 11B shows an end view of a locator element of Figure 8,

Figure 12 shows the use of a discharge/collection device of Figure 1,

Figure 13 shows the use of a discharge/ collection device of Figure 9, Figure 14 shows how a urinary aid of the present invention fits to the female anatomy,

Figure 14 shows a discharge/ collection device of the present invention in the form of a pen clip,

Figures 16 and 17 show how multiple discharge/collection devices, can be stored in an indexed manner when present without the duct,

Figure 17 show how a discharge/collection device of the present invention without the duct can be stored in a container, and

Figure 18 shows how a discharge/collection device of the present invention without the duct can be stored in a container for ease of use.

The invention can broadly be stated to relate to a small portable a

discharge/collection device that can be held against a fluid oudet. For example, such a discharge/ collection device will allow collection from a fluid oudet regardless of whether the body that is being sampled is crouched, standing, sitting or leaning against a support.

The a discharge/ collection device comprises:

^■ an engagement head 2 formed of a locator element 3 and an conformable material attached or formed unitarily with the locator element 3,

^■ a duct 4 (that may be supplied with the a discharge/ collection device or supplied separately and attached to the a discharge/ collection device just prior to use), and

^■ optionally a shell 11.

The a discharge/ collection device 1 is formed from an engagement head 2 that is attached to a duct 5 whereby the engagement head is placed against the mouth of the fluid oudet to form a seal. Preferably there is located on or about the locator element 3 conformable material 4. The conformable material 4 can form a layer on top of the locator element 3 so that when placed against the fluid outlet it forms a soft layer between the use and the locator element 3. In addition, or alternatively, the conformable material 4 can be located radially outwards and around the locator element 3.

Preferably the conformable material 4 is of a lower density than the locator element 3. In these embodiments the locator element 3 is more rigid than the conformable material 4 and may also have a higher density. The conformable material 4 is preferably soft and absorbable so as to be comfortable for the user and to prevent seepage of any fluid that escapes during use.

In some embodiments, the duct includes a one-way valve. The valve is preferably designed to open in response to the accumulation of a certain amount of fluid. The purpose of such a valve is to prevent dribbles emanating from the fluid discharge end of the duct which may mark the user's clothing. The valve collects that small amount of dribble and prevents it from dribbling out of the end of the duct. Preferably the valve only opens when about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45 or 50 ml of fluid is accumulated, and useful ranges may be selected between any of these values (these values for example, about 1 to about 50, about 1 to about 40, about 7 to about 47, about 12 to about 50, about 17 to about 24, about 21 to about 49, about 26 to about 43, about 31 to about 50, about 38 to about 46, about 41 to about 48).

When sealed against the user and the duct 5 having been filled with fluid, a vacuum may form. In some embodiments, the discharge/ collection device also comprises an air- excluder, aperture or inlet that allows air flow between the environment and the internal ducting of the discharge/ collection device 1 so that when in use, and the aid is sealed against the user, air can pass in or out of the discharge/collection device, without needing to pass through the fluid outlet end of the duct, to avoid a vacuum forming.

In one embodiment, the discharge/ collection device is comprised of engagement head 2 that comprises at the fluid receivable end 6 a number of concentric seals

concentrically disposed from each other. Preferably the first seal is disposed concentrically around the fluid receivable end 6 of the engaging head 2 and is adapted to fit conformably about the mouth of the fluid outlet. As seen in Figure 5, a device may include multiple seals including an inner seal 13 and an outer seal 14. As further seen in Figure 5, the outer seal may be raised in relation to the inner seal.

In some embodiments the device may comprise multiple seals, each seal being disposed concentrically and radially outwards of the inner seal. Bach seal helps ^" reduce the potential for fluid leakage to occur.

An advantage of the discharge/collection device 1 of the present invention is that it is of a very small size. In some embodiments the size of the engagement head is 10, 5, 20, 25, 30, 35, 40, 45 and 50 millimetres, and useful ranges may be selected from any of these values (for example, about 1 to about 40, about 7 to about 47, about 12 to about 50, about 17 to about 24, about 21 to about 49, about 23 to about 47, about 26 to about 43, about 28 to about 43, about 31 to about 50, about 35 to about 41, about 38 to about 46, about 41 to about 48).

Preferably the thickness of the engagement head is approximately 5, 10, 15, 20, 25, 30, 35, 40, 45 and 50 millimetres, and useful ranges may be selected between any of these values (for example, about 1 to about 40, about 7 to about 47, about 12 to about 50, about 17 to about 24, about 21 to about 49, about 23 to about 47, about 26 to about 43, about 28 to about 43, about 31 to about 50, about 35 to about 41, about 38 to about 46, about 41 to about 48).

Engagement head

The engagement head 2 engages to the mouth of the fluid oudet to form a seal. The engagement head 2 has an essentially tube-like arrangement to allow the passage the fluid from the fluid receivable end 6 to the fluid discharge end 7 of the engagement head 2.

In some embodiments the engagement head 2 can be sold separately to a duct 5, .the discharge/collection device 1 being capable of assembly by attaching the duct 5 to the fluid dischargeable end 7 of the engagement head 2.

At the fluid receivable end 6 of the engagement head 2 there is present a locator element 3 that extends transversally to the walls of the engagement head 2. The locator element 3 comprises an aperture to allow flow of fluid through the engagement head 2 to the fluid discharge end 7 of the engagement head 2.

The engagement head 2 also includes the conformable material 4, that can be formed either as a layer on top of the locater element 3 or formed radially about the locator element.

The engagement head 2 may also include a liquid impermeable shell 11.

Locator Element

Figure 1 shows a discharge/ collection device 1 with the locator element 2 shown in greater detail in the cross-section in Figures 2 and 3. The locator element 3 helps to locate the discharge/collection device 1 to the mouth of the fluid oudet to form a seal between the discharge/collection device 1 and the user. A feature of the locator element 3 is its ability to "self align" to the mouth of the fluid outlet which helps form a seal and prevent leakage of the fluid. More preferably the locator element 3 of the urinal aid 1 aligns against the urethral meatus.

It should be appreciated that the locator element 3 and the conformable material 4 of the engagement head 2 may be manufactured as one piece, for example, through plastic moulding. Alternatively the locator element 3 and the conformable material 4 of the engagement head 2 could be formed as separate pieces which are then bonded to each other.

As seen in detail in the cross-section shown in Figures 2 and 3, the locator element 3 is positioned substantially transverse to the walls of locator element 3. The locator element 3 has an inner region 8 and an outer region 9. The inner region 8 of the locator element 3 is located radially inwards of the walls of the engagement head 2 and the outer region 9 of locator element 3 is located radially outwards of the walls of the engagement head 2.

The operation of the locator element 3 is shown in Figure 2 by the arrows. Force applied to the inner region 8 of the locator element 3 causes the inner region 8 to be deflected inwardly to the engagement head 2 causing a simultaneous deflection of the outer region 9 of the locator element 3 towards the user. This actuation of the locator element 3 is similar to a fulcrum action with the axis of rotation being about where the wall of the engagement head 2 meets the locator element 3.

As mentioned above, in some embodiments the locator element 3 is a rigid material, as a too soft material would merely deflect without leading to a simultaneous deflection of the outer region 9.

In some embodiments the locator element 3 locates solely on the mouth of the fluid oudet.

For a urinary aid, the mouth of the urethra is surrounded by a raised circular portion (like the mouth of a volcano). The vaginal opening is located below the fluid outlet and both openings are surrounded by the labia minora. The whole region is surrounded by the labia majora. The urinary device 1, when in use, is centred upon the mouth of the urethra opening and the raised surrounding portion of the urethra and placed such that the engagement head 2 lies within the folds of the labia minora. One advantage of the locator element is that it helps locate the device onto the mouth of the fluid oudet.

The locator element ma)' have a projection 10 as seen in Figures 9 and 10. The projection 10 inserts into the urethra, the projection 10 having smooth round edges and is small enough to centre on the fluid outlet. For example, the. projection 10 may be a bulging elliptical section or a cylindrical tube. Typically the entry is only a few millimetres into the mouth of the urethra, thus causes minimal or no discomfort to the user.

As described above, in other embodiments the locator element is a soft seal that presses around the mouth of the urethra avoiding the need to insert it into the fluid oudet. Conformable material

The engagement head 2 includes conformable material 4, for enhancing the comfort of the device in use and helping prevent leakage of any fluid.

In some embodiments the conformable material 4 is compressible. Preferably the conformable material is also absorbable. In some embodiments the conformable material 4 is made of a fibrous material such as used in nappies. It should be appreciated that other material could be used such as wood pulp (that is highly absorbent), polyacrylate polymers (a highly absorbent material in powdered form) that may be packed inside a layer of wood pulp an absorbing fabric, an absorbing paper, gelatin,, starch, cellulose, alginate or carageenan, or a combination thereof. As seen in Figures 1 and 2 the conformable material 4 may be formed radially outwards of the locator element 3 so that when in use, the conformable material 4 is displaced forwards and forms a seal against the user.

As further shown in Figures 1 and 2 the conformable material 4 can be

manufactured to surround the entirety of the engagement head 2. In some embodiments the locator element 3 and conformable material 4 are formed from two different materials, the locator element 3 being formed from a material with a higher rigidity than the conformable material 4. In some embodiments, or additionally, the conformable material 4 has bonded to the locator element 3. This bonding can be in the form of gluing, heat compression, or any other method known in the art. As shown in Figure 3B the conformable material 4 may be formed as a layer on top of the locator element 3. In such embodiments, when the engagement head 2 is placed against the fluid oudet the conformable material 4 is pressed against the user. The locator element 3 still actuates since the mouth of the fluid outlet presses against the inner region 8 of the locator element 3 pushing the outer region 9 of the locator element 3 against the user.

The conformable material may be formed as a layer along the outer region of the locator element 3. In this form the locator element will position against the fluid outlet and the conformable material 4 will also form a seal adjacent the locator element 3.

In some embodiments the locator element 3 and the conformable material 4 are formed from a single material. For example, the locator element 3 and the conformable material 4 may be formed from -a÷ plastic such as polystyrene or polyurethane. The increased rigidity of the locator element 3 compared to the conformable material 4 can be provided for through differential compression of the locator element 3 and the conformable material. For example, to obtain a locator element 3 that has a higher rigidity than the conformable material 4 the material that is to form the locator element 3 can be subjected to a higher compression than the material that is to form the conformable material 4. Such

manufacturing will result in a locator element 3 having a greater density and rigidity in comparison to the conformable material 4.

In some embodiments the surface of the locator element 3, conformable material 4 or the entire engagement head 2 is coated or imbibed with an antibacterial or antiseptic film for hygiene and comfort. It should be appreciated that other additives such as scent could be coated to or imbibed into the locator element 3, and/or the conformable material 4 of the engagement head 2.

Shell

In some embodiments the discharge/collection device 1 comprises a shell 11 that encapsulates the lower portion of the engagement head 2. The function of the shell 11 is to hold and contain the engagement head 2 (that comprises the locator element 3 and the . conformable material 4). Preferably the shell 11 is impervious to liquid and thus provides an impenetrable membrane that liquid cannot pass through. This will prevent any leakage of fluid outside of the discharge/ collection device 1. It should be appreciated that the shape of the shell 1 1 conforms to the engagement head 2 of the discharge/collection device 1. For example, in those embodiments where the conformable material 4 is located about the locator element 3 the shell 1 1 will be formed about the conformable material 4. In those embodiments where the conformable material 4 is formed as a layer on top of the locator element 3 dien the shell 1 1 may form a layer about the engagement head 2 up to the edge of the locator element 3.

The shell 11 can be formed from any impermeable material such as a plastic or coated fibreboard. For example, some fibreboard has a coating that makes it impervious and/or less impervious to liquid. In some instances this may be a plastic coating.

Duct

The discharge/collection device I comprises a duct 5 diat attaches to, or within, the fluid discharge end 7 of the engagement head 2.

The purpose of the duct 5 is to direct fluid away from the engagement head 2. It should be appreciated that the lengdi of the duct 5 can be at any length and can include any number of the different modifications such as a flexible bellow 12 (as seen in Figure 4) or it could be formed telescopically. The advantage of a telescopic duct is that it makes the discharge/collection device 1 more compact.

In some embodiments the engagement head 2 and die duct 5 could be sold separately or assembled separately. For example, prior to use die duct 5is inserted into the fluid discharge end 7 of the engagement head 2 to complete die assembly of the

discharge/collection device 1. At this point the discharge/collection device 1 is ready, for use.

In other embodiments directed to a urinary device, owing to the compact size of the engagement head 2 it could form part of a panfy or a device that is worn by a female, so that when the female wishes to urinate they merely need to either lower their zip or undo their buttons of the pants and insert die duct 5 into the urine receiving end 6 into the engagement head 2. In some embodiments the duct 5 may be connected to the engagement head 2, but stored in a compact arrangement.

The lengdi of the duct 5 may be straight or curved or made of flexible or stiff material. In some embodiments the tube has an expanding concertina arrangement that allows the tube to be bent so as to direct the fluid flow.

In some embodiments the tube comprises a number of valves that assists in die collection of particular amounts of fluid. For example, the discharge/ collection device 1 could be used to sample urine. The use of multiple valves could assist in diis by collecting the initial urine flow, which is die disposed of, so as to sample the mid-stream urine flow for analysis. A number of different valves could be used diat are responsive to a collection of a certain amount of urine or diat can be manually opening or closed or are of a squeezable valve sort, squeezing of the valve cause deformation of the valve allowing urine to flow d rough. The tube may also incorporate bellows or a pump. The pump or bellows could be useful for developing a positive pressure to suck liquid from the liquid-expelling opening.

Use of a discharge/ collection device

As stated above, prior to use the device the discharge/collection device 1 can either be formed as a complete device or can be assembled prior to use. For use, as a urinary aid, the female user parts the lips of her labia minora applying the locater element 3 against the mouth of the urethral opening. In those embodiments where die conformable material 4 is formed as a layer on the locator element 3 it will be the conformable material 4 that actually engages to the user. Once the female user begins to urinate, the fluid flows through d e engagement head 2 and into the duct 5. It should be appreciated that as females may have different anatomy the discharge/collection device can be manufactured in variety of sizes to suit. It should also be appreciated diat the locater elements 3 seen in Figures 2 and 1 would not normally be visible, except with a tube, as it would be covered by the folds of the labia minora.

Alternatively, in some embodiments the conformable material 4 forms a layer merely over the outer region 9 of die locater element 3. In such an arrangement, the locater element 3 will contact the mouth of the fluid oudet and be displaced inwards thereby causing a corresponding outward displacement of the outer region 9 of the locater element 3 bring the conformable material 4 that is present as a layer over the outer region 9 of the locater element 3 against the user to form a seal. In a further embodiment the conformable material 3 may both be formed (1) on the locator element 3 and (2) radially about the locator element 3.

Shown in Figure 12 is an example of a discharge/collection device 1 wherein the discharge/collection device 1 comprises an engagement head 2 with the conformable material 4 located radially about the locater element 3. It is seen in Figure 12 that upon engagement of the locater element 3 with the moudi of the fluid oudet die outer region of the locater element 3 is displaced forwards causing a seal to be formed by the conformable material 4 against the user. Therefore, should any fluid escape between the seal formed between the locater element 3 and the mouth of the fluid oudet, the fluid will be caught by the conformable material 4 which will prevent leakage.

In those embodiments comprising a projecUon 10 as seen in Figure 13, the

projecUon is inserted into the fluid oudet and the seal is formed about the projecUon.

The device could be used at accidents to help a trapped person to discharge urine, to sample blood, or obtain fluid from any bodily fluid oudet. Portability

An advantage of the discharge/collection device 1 of the present invention is its small size and thus greater portability. As shown in Figure 15 and 17 are examples of how a discharge/collection device 1 could be index stacked for ease of portability. Such index stacking could also be used in a dispenser unit. If used as a urinary aid, a dispenser could be placed in a urinal.

In some embodiments the index stacking of die discharge/collection device 1 could be in a device as shown in Figure 14. Figure 14 shows a cylindrical pen-type carrying arrangement that can be clipped to the top of a trouser pocket or carried in a purse or handbag or other such thing. The outer body is a cylindrical body that can house the duct. The upper part of the cylindrical pen-type arrangement shown in Figure 14 may include a top cover that is removed from prior to use. The pressure of die pen may be used to push a carriage passed through a raised ridge to bring the engagement head 2 to- the top of the cylindrical pen.

The stack arrangement of the engagement head 2 could be used with a tube arrangement as shown in Figure 17. Here the ducts 5 are arranged radially which can be used with die pen like arrangement to prepare a discharge/collection device 1.

For example, pushing down on a portion on the top of a pen (i.e. a ring) can engage an engagement head 2 dirough the insertion of a duct 5 within to the engagement head 2. The assembled discharge/collection device 1 can dien be removed from the pen like device and utilised. The discharge/collection device 1 can then be d rown away. Second and subsequent discharge /collection devices can be prepared in die same manner through pushing down on die ring that engages each subsequent engagement head 2 with a duct 5.

As seen in Figure 18 is a pack that could be used to transport a number of engagement heads and/or tubes 5. The engagement heads can be mated with a duct at a later point prior to use. Method of manufacture

Another aspect of the invention relates to a method of making a discharge/collection device of the present invention comprising the steps (in no particular order) of:

forming the locater element,

forming die absorbable material on or about the locator element,

attaching a duct to the locator element and absorbable material pair,

such that when in use the fluid passes from the urethra past the locator element and into the duct.

In some embodiments tiiat are directed to a urinary aid, the element is adapted to seal about the mouth of the urethra. In some embodiments the locator element is formed unitarily widi the absorbable material. Preferably the locator element material is compressed to form it as a rigid material. More preferably die locator element and absorbable material are compression moulded, with the locator element material having greater compression (and thus increased density) compared to the absorbable material. In an alternate embodiment the locator element and the absorbable material are formed from separate materials. Preferable the locator element and the absorbable material are bonded to each other. In one embodiment the locator element and the absorbable material are heat moulded together, the heat moulding bonding the two materials together.

In some embodiments, the discharge/ collection device 1 is formed as an expandable blank that can be expanded to the use condition through inflation or expansion of the lie-flat blank. The advantage of such a lie-flat blank is that it will be easy to store and transport. For example, the engagement head 2 that defines the locater element 3 and the conformable material 4 may be made from material that is compressible. This compressible material would have a memory so that when flattened and released from that flattened state, to which it is biased, it will form the three-dimensional state that is the condition for use. The duct may yet form part of the device or be inserted into the bias following its transition from the flat state to the fully 3-dimensional in use state.

In one embodiment the discharge/ collection device 1 is packaged in a compressed condition. Preferable the compressed discharge/ collection device is biased to reform to its 3-dimeiisional condition.

•It should be appreciated that may different methods could be used to manufacture the device the discharge/ collection device 1 of the present invention. Such methods may use compression moulding or heat moulding if the conformable material 4 and the locater element 3 of the engagement head 2 are formed from either the same material or differing materials.

Biodegradability

In some embodiments, part or all of the discharge/collection device 1 is

biodegradable. For example, in some embodiments the engagement head 3 is biodegradable. In alternate embodiments, the engagement head 2 and the duct 5 are both biodegradable.

In alternate embodiments, the conformable material 4 may be biodegradable as may also be the duct 5 or the locater element 3 or the shell 11.

In some embodiments at least part thereof of the discharge/ collection device 1 is biodegradable. Preferably the locator element 3 is biodegradable. Preferably the locator element 3 and the conformable material 4 are both biodegradable. Preferably the locator element 3, the conformable material 4 and the duct 5 are all biodegradable. Preferably the conformable material 4 is biodegradable. Preferably the conformable material 4 and the duct 5 are both biodegradable. More preferably the entire device 1 is biodegradable.

In summary, some features of the discharge /collection device 1 of the present invention include: ^■ The discharge/ collection device 1 uses a conformable material 4, that preferably is absorbent, that forms a seal around the fluid outlet as it compresses to the shape of an individual's anatomy. This removes any need to press a cup shape item over the fluid outlet using a shield or a covering.

^■ The discharge/ collection device 1 can be disposed off after a single use. EXAMPLE - URINARY AID

The urinary aid 1 of this example is compact and portable. It enables women to urinate like a male. The urinary aid 1 is held against the female's urethra opening, within the folds of labia minora, without covering the vaginal passage opening or the pubic area. The urinary aid is made available in standard sizes, without the need to be personalised. The urinary aid consists of a locator element 3 that locates the urinary aid 1 to the fluid oudet to direct the flow of urine away from the fluid outlet with minimal or no leakage to the surrounding area. Two types of urinary aids are available. The first urinary aid is a modified nozzle that forms a contoured face circular seal when pressed around the mouth of urethra. The forward end sits away from the urethra and has a circular opening of comparatively generous section through which the urine flows. The second aid has a smooth rounded edge hollow nozzle that is small enough to be inserted into the urethral opening. The forward end sits away from the urethra and has a circular opening of comparatively generous section through which the urine flows.

The urinary aid also includes an absorbing seal element that is made of a highly , absorbent material. This absorbing seal element is about 5 mm in thickness and forms a tight surface contact seal with the wall of labia minora so as to absorb any. leakage that may escape past the locator element. The locator element, whether the smooth rounded edge nozzle or the profiled circular seal, has a circular passage that is in line with the axis of the locator element that is coated to make it liquid resistant. This ensures the urine cannot leak to the surrounding regions. The outer edge of the contoured face has a profile to suit the region surrounding the urethra opening within the labia minora. This is a bottom semicircular with a triangular top with a rounded apex to suit the triangular region of a female's anatomy within the labia minora around the urethra opening.

The part of the urinar)' aid that does not come into contact with the urethra is covered by a thin plastic part referred to as the shell element. The shell element is shaped to cover the surface of the absorbing seal element. The shell element has a hollow saucer-like shape, or cylindrical shallow dish-like shape, with the hollow portion facing the urethra. The shell element closely conforms to the shape of the absorbing seal element, with a circular opening located at the end opposite to the urethra through which a thin wall tube ("tube element") is inserted. The tube element is inserted in the absorbent seal element to direct the urine away from the user and is made of thin plastic material, or material that is coated to make the passage temporary impervious to urine. The tube may be straight or curved, with slight flexibility to direct the flow, or with a bellow-type portion that permits bending of the tube , up to about 45 degrees. Urinary aids are produced with locator elements, absorbing seal elements, shell elements and tube elements of particular sizes and profiles to account for the varying sizes and shapes of women anatomy in the urethra region. The urinar ₎ ' aid is also made of particular material (biologically degradable or recyclable), and with particular surface coatings to account for personal preferences regarding hygiene and comfort. In one type of urinar)' aid the locator element is a smooth rounded edge short nozzle made of plastic material. For example, polycarbonate, medical grade thermo-sensitive PVC material that is a non-irritant to the delicate mucous membranes of the urethra, LDPE or plastic material that is elastic and easy to mould in thin sections, or coated paper/ fabric. This type of locater element has an inserting end that is small enough to be inserted into the urethra, a slightly bulging section along the axis in the middle of the nozzle that may be circular or elliptical so as to make good contact with the walls of urethra, yet is of thin elastic section so as not to cause discomfort to the user.

Attached is a washer like rigid ring that snugly fits into a groove in the absorbing seal element that permits small movements to facilitate alignment with the urethra passage. It is generally of circular section having a comparatively larger sectional area to permit easy flow of urine. For the locator element of a type that is inserted into the urethra, it is coated with a fine filament of lubricant to ease insertion. The lubricant is like a moisturizing body lotion an includes an anti-bacterial and perfume.

For the locator element of a type that forms a contoured face circular seal when pressed around the mouth of the urethra opening, it is connected to a washer like rigid-ring. This connection is by way of a circular passage, that is a thin tube like structure. The washer-like rigid ring fits into a groove in the absorbing seal element to permit small movements of the contoured circular face seal so that it can self align with the mouth of the urethra and also permit the flow of urine. The contoured face of the circular seal is a concave inner annular ring and convex outer annular ring, for example, somewhat like a saucer with a central hole, blended to form an effective seal with the region around urethra opening. The contoured face circular seal connected by the thin tube to the rigid ring is moulded in one piece. - -

In another form the contoured face circular seal is formed by having a raised annular projection on the face of the absorbing seal element to form an effective seal with the region around urethra opening. It has a central circular passage in the absorbing seal element that is coated to make the passage temporary impervious to urine.

The absorbing seal element is made of highly absorbent material such as wood pulp, or contain polyacrylate polymers (an absorbent material in powder form packed inside layer of wood pulp), and/or absorbing fabric/paper and may be coated with an antibacterial/ antiseptic film to provide hygiene and comfort.

The shell element is formed by moulding from plastic material or chemically treated compressed fabric/ aper. Another form of the shell is produced by coating the surface of the absorbing seal insert element, that is not in contact with the labia minora region, with a plastic film or lacquer or chemical treatment to form a fairly firm, impervious liquid resistant surface.

The urinary device can be assembled as one piece or in two or more sub assemblies. The subparts can easily be assembled with each other by mere insertion into one another. Such an arrangement facilitates the use of an "easy-carry" and discreet urinary aid such as, for example, a thick clip-on pen, or a compact box. These can be carried in a purse or kept in a pouch of the undergarments to provide for a female's urinary requirements for a day or Where in the foregoing description reference has been made to elements or .integers having known equivalents, dien such equivalents are included as if diey were individually set forth.

Although the invention has been described by way of example and with reference to particular embodiments, it is to be understood that modifications and/or improvements may be made without departing from the scope or spirit of die invention.