DK181609B1

DK181609B1 - A device for collecting midstream urine from a human individual

Info

Publication number: DK181609B1
Application number: DKPA202330215A
Authority: DK
Inventors: Fleischer Jesper; Geert Jensen Anders; Christian Boldsen Peter; Haaning Charles Morten
Original assignee: Aarhus Medical Aps
Priority date: 2023-09-19
Filing date: 2023-09-19
Publication date: 2024-06-26
Also published as: DK202330215A1

Abstract

The invention relates to a urine collection device (100) for collecting midstream urine; wherein said device, in the orientation intended during urine collection, comprising: a first recipient (2) for urine; a second recipient (4) for urine; a urine diverting means (5); wherein said urine collection device (100) comprises a third recipient (14) for urine, wherein said third recipient for urine comprises an evacuated container; or wherein said third recipient (14) for urine comprises a container which is configured for becoming evacuated by being in fluid connection with a vacuum pump; wherein said urine collection device comprises a conduit (16) having an opening (18) in a first end (20) and an opening (22) in a second end (24) thereof; wherein said first end (20) of said conduit (16) is arranged at the interior of said second recipient (4) for urine; ´wherein said opening (22) in said second end (24) of said conduit (16) is in fluid connection with the interior of said third recipient (14) for urine; wherein said first end (20) of said conduit (16) comprises a flexible tubing (70) which has been bend so as to comprise a tube kink (72); wherein said tube kink (72) is being hold in place by a tube kink retaining element (74), wherein said tube kink retaining element (74) is being made of a moist-soluble material, thereby making said tube kink seal off a vacuum which is being present in said third recipient (14) until dissolution of said moist soluble material and subsequent unfolding said flexible tubing (70) of said tube kink (72).

Description

A device for collecting midstream urine from a human individual

Field of the invention

The present invention relates in general to the field of medical equipment. More specifically the present invention relates in a first aspect to a urine collection device for collecting midstream urine. In a second aspect the present invention relates to a wearable device comprising a urine collection device according to the first aspect. In a third aspect the present invention relates to the use of a urine collection device according to the first aspect of the present invention or of a wearable device according to the second aspect of the present invention for collecting a midstream portion of urine from a human individual.

Background of the invention

Within the field of medicine, it is customary to collect samples from a human body in order to examine such samples with the aim to deduct a diagnosis relating to various conditions of the individual, from which the sample has been collected.

Such samples to be collected may relate to tissue or bodily fluids.

Collecting and examining urine from an individual may accordingly form the basis for an essential examination to diagnose a potential bacterial infection in the urinary tract.

Examples of inflammations in the urinary track and examples of other medical conditions — which may be diagnosed from urine are: general infections, bladder infections, autoimmune diseases, bladder cancer, kidney functions, pregnancy, diabetes 1, diabetes 2, internal bleedings, poisonings and prostate.

However, as the urethra is prone to contain bacteria originating from its opening’s exposure to the surroundings, a mere uncritically collection of urine and a subsequent diagnosis conducted — on such urine may lead to false positive results in relation to identification of bacterial infections in the individual from which the urine has been collected.

For this reason, when conducting a diagnosis on the basis of urine from an individual, it must be assured that the collected urine, which is subjected to the diagnosis, is not forestream urine which may be prone to contain bacteria which have an external origin; rather, it must be assured that the collected urine is so-called “midstream urine”, which is defined as urine not belonging to the first portion of urine situated in the urethra and being emptied by the individual.

It is a generally accepted definition that midstream urine is that portion of urine, being emptied from a human individual, which does not belong to the first 10 milliliters of expelled urine.

DK 181609 B1 2

Whereas healthy adult persons without any assistance, except receiving instructions, will be able to urinate into a urine collection recipient in such a way that only a midstream portion of urine is collected, there are groups of persons in respect of whom the situation is different.

Examples of such group of persons are disabled persons, weak or diseased persons, small children, persons with reduced motility control and persons with reduced bladder control.

In respect of collecting a midstream urine, devices have been provided which are able to collect both a forestream and a midstream portion of urine and wherein the device provides for automatically separating the midstream portion from the forestream portion of urine.

One such device is disclosed in WO 2008/094771 A1. This document discloses a device and a — method for collecting a midstream urine. The device comprises a tube through which urine is being led. A lower part of the tube comprises a through-going hole which is covered with a water soluble cover. Once urine is being led into the tube, a first portion of urine will pass the whole tube. Having been exposed for urine for a short period of time, the water soluble cover will eventually dissolve and urine will subsequently be directed from the tube, through the through-going hole in the tube and into a collector arranged below the through-going hole. In this way, the collection of only midstream urine is assured.

Another example of a device for collecting a midstream portion of urine is disclosed in US 2005/0240164 Al. This document discloses a disposable device for collecting a midstream portion of urine, especially intended to be worn by small children. — The device disclosed in US 2005/0240164 A1 comprises a collection bag for urine. The collection bag comprises an opening which is provided with a delaying mechanism. An absorbent material is provided on the bag in such a way that this absorbing material surrounds the opening. The delaying mechanism may comprise a cover covering the opening which cover is being made from a urine dissolving material. The working mode of the device US 2005/0240164 Al is as follows: a first stream of urine being led to the outside of the collection bag in the area above the cover of the opening will be directed to the absorbing material surrounding the opening and will be absorbed by this absorbing material. Once being exposed to urine, the delaying mechanism will after a short while provide for access to the interior of the bag. Thereby the midstream portion of urine will be collected in the bag.

Although devices have been developed which provide for separating and collection of a midstream portion of urine from a forestream portion of urine, these devices nevertheless presents a number of disadvantages.

One of these disadvantages is that once a midstream portion of urine has been collected by these devices, this portion of midstream urine need be handled and transferred to a proper vial in which the urine can be stored until the process of conducting the analysis leading to a diagnosis.

Such handling necessitates human involvement and hence represents labor time needed in respect of nurses or assistants, inconvenience and potential delays.

DK 181609 B1 3

Moreover, human handling of urine samples collected by the prior art devices involves the risk of exposing the urine samples for bacteria of external origin, thus representing a risk of obtaining false positive diagnosis results.

A further disadvantage of the above-mentioned prior art devices is that they do not represent a satisfactorily solution for persons suffering from lack of bladder control and therefore must use diapers.

In WO 2019/242823 Al is disclosed an improved device for collecting a midstream portion of urine with the view to perform a proper diagnosis on this portion of urine and which avoids false positive results.

The device disclosed in WO 2019/242823 A1 comprises a first recipient for urine, a second recipient for urine, a third recipient for urine and a urine diverting means. The third recipient for urine comprises an evacuated container. The device is designed in such a way that a first portion of urine directed to the device will be guided to the first recipient for urine and in such a way that a midstream portion of urine will be guided to second recipient for urine. A conduit is connecting the second recipient for urine with the evacuated third recipient for urine. The end of this conduit which being present in the second recipient for urine comprises a moist- soluble plug. Upon being moist by urine entering the second recipient for urine, this plug will dissolve and due to the vacuum in the third recipient for urine the urine originally collected in the second recipient for urine will be sucked into the third recipient for urine which subsequently can be removed from the device and transferred for analysis.

Although the device disclosed in WO 2019/242823 Al in many situations provided for a satisfactorily collection of a midstream portion of urine, this device in some situations presents some shortcomings.

One of these shortcomings is that in order for the soluble plug in the conduit connecting the — second and the third recipient for urine to withstand the vacuum being present in the third recipient for urine, this plug needs to have certain minimum physical dimension. Such certain minimum physical dimension will imply a certain magnitude of time delay from the time where urine is received in the second recipient for urine to the time where that moist-soluble plug is dissolved so that the urine can be sucked into the third recipient for urine.

In other words, with the device disclosed in WO 2019/242823 Al, the selection of the necessary physical magnitude of the moist-soluble plug, will dictate the magnitude of delay from the time where urine is received in the second recipient for urine to the time where that is being transferred to the third recipient for urine.

In certain medial applications, such delays are undesirable.

Itis an objective of the present invention to provide devices and uses which overcome the disadvantages of the prior art devices.

Brief description of the invention

These objectives are fulfilled according to the first, the second and the third aspect of the present invention.

Accordingly, the first aspect of the present invention relates to a urine collection device for collecting midstream urine; wherein said device, in the orientation intended during urine collection, comprising: -a first recipient for urine; -a second recipient for urine; -a urine diverting means; wherein said urine collection device comprises a third recipient for urine, wherein said third recipient for urine comprises an evacuated container; or wherein said third recipient for urine comprises a container which is configured for becoming evacuated by being in fluid connection with a vacuum pump; wherein said urine collection device comprises a conduit having an opening in a first end and an opening in a second end thereof; wherein said first end of said conduit is arranged at the interior of said second recipient for urine; wherein said opening in said second end of said conduit is in fluid connection with the interior of said third recipient for urine; characterized in that said first end of said conduit comprises a flexible tubing which has been bend so as to comprise a tube kink; wherein said tube kink is being hold in place by a tube kink retaining element, wherein said tube kink retaining element is being made of a moist- soluble material, thereby making said tube kink seal off a vacuum which is being present in said third recipient until dissolution of said moist soluble material and subsequent unfolding — said flexible tubing of said tube kink.

In a second aspect, the present invention relates to a wearable device for collecting urine from a human individual, wherein said wearable device comprises a urine collecting device according to the first aspect of the present invention; wherein said wearable device comprises a material having an inner surface configured to face at least a lower portion of the pelvic region of a human individual, and an outer surface arranged opposite to the inner surface.

In a third aspect the present invention relates to a use of the urine collection device according to the first aspect of the present invention, or of a wearable device according to the second aspect of the present invention for collecting a midstream urine from a human individual.

The present invention in its various aspects provides for an improved urine collection device and an improved wearable device for separating a midstream portion from a forestream portion of urine and for collecting such midstream portion of urine in an easy and convenient way among human individuals with no clear bladder control, which moreover reduces the risk of contamination of the collected midstream urine with bacteria of external origin.

Especially, the present invention provides for predetermining the magnitude of delay in time 5 from the time where urine is received in the second recipient for urine to the time where that urine is being transferred to the third recipient for urine by means of the vacuum being present in that third recipient.

Moreover, once collected in the third recipient, the portion of midstream urine collected may in the very same container be stored and transported to the analysis laboratory without the necessity for further handling of the urine sample per se by medical personnel. Accordingly, the risk of contamination after collecting the midstream urine sample is considerably reduced.

Brief description of the figures

Fig. la is a diagram illustrating the working mode of the urine collection device according to the general first aspect of the present invention.

Fig. 1b is diagram illustrating the working mode of the urine collection device of fig. la furthermore comprising urine retaining means.

Fig. 1c is a cross-sectional view illustrating the concept of including baffles in the urine collection device.

Fig. 1d is a diagram illustrating one specific embodiment of the urine collection device according to the general first aspect of the present invention.

Fig. le is a diagram illustrating a variation of the embodiment illustrated in fig. 1d.

Fig. 1f is a diagram illustrating another specific embodiment of the urine collection device according to the general first aspect of the present invention.

Fig. 2 isa perspective view illustrating an embodiment according the urine collection device according to the first aspect of the present invention.

Fig. 3 is a cross-sectional view illustrating the device of fig. 2.

Fig. 4a is a cross-sectional view of an alternative embodiment of the urine collection device illustrated in fig. 2 and 3, further comprising an adhesive collar.

Fig. 4b is an exploded view of the urine collection device illustrated in fig. 4a.

Fig. 5 is an illustration depicting a wearable device according the second aspect of the present invention.

Fig 6a, 7a, 8a and 9a are drawings showing in a perspective view various suitable geometries of the tube kink retaining element comprised in the device of the present invention.

Fig 6b, 7b, 8b, 9b and 10 are drawings showing in a perspective view various suitable geometries of the tube kink retaining element when being used with the flexible tubing of the device of the present invention.

Fig. 11 is a cross-sectional view illustrating a special embodiment of the urine collection device according to the first aspect of the present invention.

Detailed description of the invention

The first aspect of the present invention

Accordingly, the first aspect of the present invention relates to a urine collection device for collecting midstream urine; wherein said device, in the orientation intended during urine collection, comprising: -a first recipient for urine; -a second recipient for urine; - a urine diverting means; wherein said urine collection device comprises a third recipient for urine, wherein said third recipient for urine comprises an evacuated container; or wherein said third recipient for urine comprises a container which is configured for becoming evacuated by being in fluid connection with a vacuum pump; wherein said urine collection device comprises a conduit having an opening in a first end and an opening in a second end thereof; wherein said first end of said conduit is arranged at the interior of said second recipient for urine; wherein said second end of said conduit is in fluid connection with the interior of said third recipient for urine; characterized in that said first end of said conduit comprises a flexible tubing which has been bend so as to comprise a tube kink; wherein said tube kink is being hold in place by a tube kink retaining element, wherein said tube kink retaining element is being made of a moist- soluble material, thereby making said tube kink seal off a vacuum which is being present in said third recipient until dissolution of said moist soluble material and subsequent unfolding said flexible tubing of said tube kink.

By providing the urine collection device with three recipients for urine as in the design according to the first aspect of the present invention the midstream urine will automatically be separated from a forestream portion of urine and automatically collected in a recipient which is suitable for storing and transportation of the urine sample until analysis thereof.

Inclusion of a tube kink and a tube kink retaining element in the flexible tubing in the second recipient for urine provides a degree in freedom as to predetermining the magnitude of the delay from the time where urine is received in the second recipient for urine to the time where that is being transferred to the third recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine diverting means is being configured for diverting a first portion of urine being led to the position of said urine diverting means, from above, to enter said first recipient for urine; and is being configured for diverting a subsequent portion of urine being led to the position of said urine diverting means from above, to enter said second recipient for urine.

Hereby a separation of urine into a first stream of urine and a subsequent stream of urine is accomplished.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine diverting means is being positioned at or above an upper opening of said second recipient for urine.

Hereby urine may be separated into a first stream of urine and a subsequent stream of urine — when the urine is being supplied to the urine diverting means from above.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine diverting means comprises a moist soluble membrane; wherein said moist soluble membrane is covering an upper opening of said second recipient for urine; wherein at least a part of the perimeter of said moist soluble membrane defines an entry into the first recipient for urine.

By providing the urine diverting means as a moist soluble membrane, a first stream of urine provided to said membrane will be diverted to the first recipient for urine, whereas a subsequent stream of urine provided to said membrane will enter the second recipient for urine, as that soluble membrane dissolves by the presence and contact with urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the moist soluble membrane is made from a material independently selected from the group comprising: polyvinyl alcohol, polyvinyl pyrrolidone, alginate, polyacrylamide.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine diverting means comprises a canopy covering an upper opening of said second recipient for urine, thereby preventing urine form entering said second recipient for urine from above, yet allowing subsequent urine to enter said second recipient for urine from below.

In this alternative design of the urine diverting means, a first stream of urine when supplied form above will hit the canopy and be diverted into the first recipient for urine, and as this first recipient for urine becomes filled with urine, a subsequent stream of urine will be able to flow into the second recipient for urine below said canopy and from said first recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the first recipient for urine at least partly surrounds said second recipient for urine.

Hereby a first stream of urine being led to an area above the urine diverting means will easily be allowed to flow into the first recipient for urine, whereas a subsequent stream of urine will easily be allowed to flow into the second recipient for urine

In one embodiment of the urine collection device according to the first aspect of the present invention the one or more essentially vertically arranged baffles, such as 2 — 24 baffles are arranged between the first recipient for urine and said second recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the device furthermore comprising one or more urine retaining means arranged between said first recipient for urine and said second recipient for urine, preferably along their full circumference, wherein said urine retaining means defines a relative narrow passage for urine between said first recipient for urine and said second recipient for urine, in going from an area above said urine retaining means to an area below said urine retaining means, and vice versa.

By these two embodiments the lower portion of urine (and hence a first portion of urine) being present in the first recipient for urine will be less prone to migrate into the second recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the upper opening of the second recipient for urine is being arranged below an upper rim of said first recipient for urine.

Hereby, urine will be able to flow from the first recipient for urine into the second recipient forurine.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine holding capacity of said first recipient and/or said second recipient and/or said third recipient independently is comprised within the ranges of 50 — 250 ml.

These volumes have proven to be sufficient for collection of a sufficient portion of midstream urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the conduit comprises a valve, such as a non-return valve for preventing a flow of urine in a direction from said third recipient for urine to said second recipient for urine.

Hereby it is ensured that midstream, once collected in the third recipient for urine, will not migrate back to the second recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the interior of said third recipient for urine comprises a vacuum of 600 mm Hg or less, such as 500 mm Hg or less, e.g. 450 mm Hg or less, such as 400 mm Hg or less, e.g. 350 mm Hg or less, such as 300 mm Hg or less, for example 250 mm Hg or less, e.g. 200 mm Hg or less, such as 150 mm Hg or less, for example 100 mm Hg or less, or 50 mm Hg or less.

Accordingly, in order for the urine collection device to work properly, it is not necessary to establish an absolute vacuum or a near absolute vacuum.

Rather, it is merely a requirement that the vacuum involved is sufficient for transferring, by suction into the third recipient, an amount of urine from the second recipient for urine of approximately 5 — 15 ml. The above stated magnitudes of evacuation provide for such transfer.

Such a design ensures that the forestream of urine will be diverted into the first recipient for urine, whereas the midstream portion of urine will enter the second recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the first recipient for urine comprises a urine absorbing material, such as a spongy material or a fibrous material, such as cellulose, such as cotton fiber or paper.

Hereby it can be ensured that a forestream of urine, once collected in the first recipient for urine will not splash around and thereby accidentally enter the second recipient for urine, which is allocated for midstream urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine diverting means, when viewed from the outside of said second recipient, and preferably from above, defines a convex cover covering the opening of said second recipient for urine.

Designing the urine diverting means in this configuration will aid in diverting a forestream urine into the first recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the moist soluble tube kink retaining element is made from a moist-soluble material selected form the group comprising, synthetic polymers, such as polyvinyl alcohol,

polyacrylamide polyvinyl pyrrolidone, polyacrylic acid, methyl celluloses, hydroxyethyl cellulose; or non-synthetic polymers, such as alginate, guar gum, gelatin, xanthan gum.

Such materials have proved excellent for the intended purpose of dissolving after exposure for urine for a short period of time.

In one embodiment of the urine collection device according to the first aspect of the present invention the third recipient for urine is a recipient which has previously been sterilized.

Hereby, any contamination, such as bacterial contamination of external origin can be avoided.

In one embodiment of the urine collection device according to the first aspect of the present invention the device further comprises a flow guide for directing urine, flowing or falling by — the action of gravity, to an upper part of said first and/or second recipient for urine; wherein the flow guide comprises an upper rim.

Providing the device with a flow guide aids in directing expelled urine from an individual in the vicinity of the area of the first and second recipients for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the upper rim of said flow guide is provided with an adhesive collar, thereby enabling adhering said urine collection device to the skin of a human individual.

In this embodiment the device can be used by a human individual without the necessity of being combined with a panty or a diaper.

In one embodiment of the urine collection device according to the first aspect of the present invention conduit at least partly comprises a flexible tube.

This will ease the arrangement of the third recipient for urine relative to the second recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the first end of said conduit is arranged at the interior of said second recipient for urine at a lower portion thereof.

Hereby is assured, that even if only a relatively small amount of midstream urine is collected in the second recipient for urine, this small amount will still be transferred to the third recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the first recipient for urine comprises a cover partly covering the entry into said first recipient for urine, such as by being provided with one or more openings, such as in the form of one or more holes, perforations or gaps.

Such cover will reduce the tendency of a forestream portion of urine, once collected in the first recipient for urine, to splash around and thereby accidentally enter the second recipient for urine, which is allocated for midstream urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the third recipient for urine comprises an evacuated container.

In one embodiment of the urine collection device according to the first aspect of the present invention the third recipient for urine comprises a container which is configured for becoming evacuated by being in fluid connection with a vacuum pump.

These two embodiments represent alternative ways of ensuring transfer of a midstream portion of urine, collected in the third recipient for urine, into the third recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the third recipient for urine is made of a transparent or translucent material, thereby allowing visual detection of completion of collection of a midstream portion of urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the device further comprises one or more RFID tags for identification of the identity of the urine collected.

Hereby the risk of mixing up a collected urine sample from one individual for another may be — reduced or avoided

In one embodiment of the urine collection device according to the first aspect of the present invention the device further comprises one or more sensors, such as movement sensor(s), temperature sensor(s), humidity sensor(s), optionally connected to a transmitter comprised in the device for transmitting data collected by such one or more sensors to a central receiver; said sensor and/or transmitter optionally being in the form of an RFID data logger.

This embodiment allows wireless transfer of data sensed by the sensor to a central receiver. In this way it can be detected when urination of a human individual has taken place.

In one embodiment of the urine collection device according to the first aspect of the present invention the tube kink divides said flexible tubing into a first portion comprising said — opening and into a second portion which is being in fluid connection with said third recipient for urine; wherein said tube kink retaining element touches a first area on the outside surface of said first portion as well as a second area on the outside surface of said second portion (86b) of said flexible tubing.

In this way the tube kink retaining element will be able to hold in please the kink of the tube.

In one embodiment of the urine collection device according to the first aspect of the present invention the tube kink retaining element is being in the form of a cured moist-soluble glue, such as a PVA glue, wherein said moist-soluble glue is adhering to said first area as well as a second area.

Use of glue makes it easy to determine the magnitude of the time delay involved in dissolution of the glue with subsequent unfolding of the tube.

In one embodiment of the urine collection device according to the first aspect of the present invention the tube kink retaining element comprises two inner opposing surface portions which are having geometries, dimensions and a mutual distance which are adapted to the geometry and dimensions of said flexible tubing so as to be able to retain said kink of said flexible tubing.

In one embodiment of the urine collection device according to the first aspect of the present invention the tube kink retaining element is in the form of a closed-looped ring, a closed- looped string, an open looped clip, such as a U-shaped clip, or a helix.

All these stated geometries are well-suited for the intended purpose of holding the tube kink in place until dissolution of the tube kink retaining element.

In one embodiment of the urine collection device according to the first aspect of the present invention the flexible tubing is being made of a polymer, such as a thermoplastic elastomer, such as polyethylene, polypropylene, polyvinyl chloride, silicone, polyurethane, ethylene- — vinyl acetate, fluorinated derivatives or co-polymers of any of these

In one embodiment of the urine collection device according to the first aspect of the present invention the flexible tubing is being an elastic, flexible tubing.

When the tubing is being an elastic, flexible tubing it is ensured that it will unfold when the tube kink retaining element has dissolved, thereby giving access to the vacuum in the third recipient for urine.

In one embodiment of the urine collection device according to the first aspect of the present invention the third recipient for urine comprises a leak proof coupling, such as a snap coupling for connecting and disconnecting said conduit.

Such a coupling makes it easy to remove the third recipient for urine, comprising a portion of midstream urine, from the rest of the device, for further processing in a hospital or a laboratory.

In one embodiment of the urine collection device according to the first aspect of the present invention the urine collection device is packed in a sealed package, such as a sterilized, sealed package.

In one embodiment of the urine collection device according to the first aspect of the present invention, the urine collection device comprises a first part and a second part , wherein said first part of said urine collection device comprises said first recipient for urine, said second recipient for urine and said urine diverting means; and wherein said second part of said urine collection device comprises said third recipient for urine;

wherein said first part of said urine collection device is being in the form of a wearable device adapted to be worn by a female human being and configured to be held in place between the labia majora of that female human being; wherein said first recipient for urine is being arranged below said second recipient for urine; wherein said first recipient for urine is being separated from said second recipient for urine by a wall element, wherein said wall element comprises an upwardly extending, hollow protrusion; wherein said urine diverting means is being in the form of a funnel like structure comprising an upper flow guide and a lower hollow stem, and wherein said urine diverting means is covering said second recipient for urine; wherein said hollow stem of said urine diverting means is being accommodated in said upwardly extending, hollow protrusion of said wall element; wherein the geometry and dimensions of said upwardly extending, hollow protrusion and of said hollow stem of said urine diverting means, respectively, are adapted to each other in such away that a free space is present between an outer surface of the hollow stem and an inner surface of said hollow protrusion, thereby allowing midstream urine to flow from said first recipient for urine to said second recipient for urine via said free space; wherein said first part said urine collection device comprises an opening for entry of said conduit into said second recipient for urine, and wherein said conduit is arranged in said opening.

This embodiment of the present invention allows a female user to wear the device in advance of the time of delivery of a urine sample.

In one embodiment of the urine collection device according to the first aspect of the present invention, the first recipient for urine comprises a urine absorbing material, such as a spongy material or a fibrous material, such as cellulose, such as cotton fiber or paper, wherein said urine absorbing material optionally is being arranged below said hollow stem of said urine diverting means.

Hereby it can be ensured that a forestream of urine, once collected in the first recipient for urine will be absorbed and not enter the second recipient for urine, which is allocated for midstream urine.

In one embodiment of the urine collection device according to the first aspect of the present invention, the second recipient for urine comprises an overflow opening for allowing urine to exit said second recipient for urine, such as into a diaper worn by said female human being.

Hereby, a female user will be able to urinate to an extent so as to empty her bladder as opposed to just urinating to an extent which is sufficient for delivery of an adequate amount of midstream urine for subsequent analysis.

DK 181609 B1 14

In one embodiment of the urine collection device according to the first aspect of the present invention, the extension in a longitudinal direction X of said first part of said urine collection device is selected from the ranges of 40 — 85 mm, such as 45 — 80 mm, e.g. 50 — 75 mm, such as 55 — 70 mm or 60 — 65 mm; and/or the extension in a transversal direction Y of said first part (300) of said urine collection device is selected from the ranges of 22 — 48 mm, such as 24 — 46 mm, for example 26 — 44 mm, such as 28 — 42 mm, such as 30 — 40 mm, for example 32 — 38 mm or 34 — 36 mm and/or wherein the extension in a height direction Z of said first part of said urine collection device is selected from the ranges of 22 — 48 mm, such as 24 — 46 mm, for example 26 — 44 mm, e.g. 28 — 42 mm, for example 30 — 40 mm, e.g. 32—38 mm —or34—36 mm.

These dimensions will ensure a proper and comfortable fit of the urine collection device between the labia majora of a female user.

In one embodiment of the urine collection device according to the first aspect of the present invention, an upper portion of said first part of said urine collection device comprises an at least partly surrounding outwardly extending rim which is configured to enter into engagement with part of the labia majora of that female human being upon use, wherein said rim optionally is having a thickness, as measured in a vertical direction Z, of 2 — 9 mm, such as 3 — 8 mm, for example 4 — 7 mm or 5 — 6 mm.

Such a rim participates in holding the urine collection device in place between the labia majora of a female user.

In one embodiment of the urine collection device according to the first aspect of the present invention, said urine diverting means (5) of said first part (300) is being detachably mounted to said second recipient (4) for urine. — The second aspect of the present invention

Accordingly, the wearable device according to the second aspect of the present invention makes it easy to attach the urine collection device thereof to a human individual.

In one embodiment of the wearable device according to the second aspect of the present invention the wearable device is in the form of a diaper or a panty, such as a disposable panty.

In one embodiment of the wearable device according to the second aspect of the present invention the inner surface comprises a water impermeable lining.

Such lining will aid in directing urine into the vicinity of the first and the second recipient for urine of the urine collection device thereof.

In one embodiment of the wearable device according to the second aspect of the present invention the wearable device, when being worn by a human individual, is configured in such away that said first recipient and said second recipient of said urine collection device are arranged at a lower portion of said wearable device.

This will ensure that urine, flowing downward by the action of gravity will find its way to the first and the second recipient for urine.

In one embodiment of the wearable device according to the second aspect of the present invention the urine collection device comprises a flow guide as disclosed above in respect of the first aspect of the present invention and wherein said rim of the flow guide is arranged at the inner surface of the wearable device.

In one embodiment of the wearable device according to the second aspect of the present invention the wearable device, when being worn by a human individual, is configured in such away that said first recipient for urine, said second recipient for urine and said third recipient for urine are arranged opposite to the inner surface of said wearable device.

Hereby room for these recipients are ensured.

In one embodiment of the wearable device according to the second aspect of the present invention the wearable device is packed in a sealed package, such as a sterilized, sealed package.

The third aspect of the present invention

In one embodiment of the use (not according to the third aspect of the present invention) the use does not involve any diagnostic steps per se.

According to this embodiment the use only comprises the steps of collection of midstream urine and not any subsequent analysis or diagnostic steps.

In one embodiment of the wearable device according to the third aspect of the present invention the use involves wearing the urine collection device or the wearable device by a human individual and optionally further involves wearing a standard diaper.

It is preferred that during use, the human individual wearing the device of the first or the — second aspect of the present invention, additionally wears a standard diaper on top of the

DK 181609 B1 16 device, in case the device is the urine collection device of the first aspect of the present invention or is a panty according to the second aspect of the present invention.

Referring now to the drawings for better illustrating the present invention in its various aspects, fig. la is a schematic drawing illustrating the principle of the working mode of the urine collection device of the first aspect of the present invention.

Fig. 1a shows a urine collection device 100 for collecting midstream urine.

The urine collection device, in the orientation intended during urine collection, comprises a first recipient for urine, a second recipient for urine and a third recipient for urine.

These recipients for urine are for simplicity represented by the boxes 2, 4 and 14 respectively. — Above the second recipient 4 for urine is arranged a urine diverting means 5.

As explained in more detail below the urine diverting means 5 is being configured for diverting a first portion of urine being led to the position of said urine diverting means 5, from above, to enter the first recipient 2 for urine; and is moreover being configured for diverting a subsequent portion of urine being led to the position of the urine diverting means 5, from — above, to enter the second recipient 4 for urine.

Depending on the specific design of the urine diverting means 5, a midstream of urine will either be able to enter the second recipient 4 for urine by passing through the urine diverting means 5, as illustrated by the arrow 52 in Fig. 1a; or alternatively will have to take a detour into the first recipient 2 for urine before entering the second recipient 4 for urine, as illustrated — by the combined arrows 12 and 52 in Fig. 1a.

It is seen in fig. la that a conduit 16 is having an opening 18 in a first end 20 and an opening 22 in a second end 24 thereof is included in the urine collection device.

The first end 20 of the conduit 16 is arranged at the interior of the second recipient 4 for urine.

The second end 24 of said conduit 16 is arranged at the interior of said third recipient 14 for urine.

In the urine collection device according to the first aspect of the present invention the third recipient 14 for urine comprises an evacuated container, thereby representing a vacuum.

Fig. 1a shows that end 20 of the conduit 16 comprises a flexible tubing 70 which has been bend so as to comprise a tube kink 72. The tube kink 72 is being hold in place by a tube kink retaining element 74.

The tube kink retaining element 74 can be designed in various geometrical shapes and explained further below with reference to Fig. 6a, 7a, 8a, 9a and 10.

However, for the sake of simplicity, in Fig. 1a the tube kink retaining element 74 is symbolically and simply illustrated by the cross X. The same applies in respect of Fig. 1b, 1d, le, If, 3, 4 and 5.

DK 181609 B1 17

The tube kink retaining element 74 is being made of a moist-soluble material. In this way the tube kink seals off a vacuum which is being present in the third recipient 14 until dissolution of the moist-soluble material of the kink retaining element 74 and subsequent unfolding of the flexible tubing 70 of that tube kink 72.

In use the urine collection device 100 is arranged so that a first portion of urine falling or flowing by the action of gravity, as indicated by the arrow U, will, by virtue of the urine diverting means 5, be diverted so as to enter the first recipient for urine 2, whereas a subsequent portion of urine will be allowed, again by virtue of the urine diverting means 5, to enter the second recipient for urine 4. This is described in more detail below.

The stream of urine collected in the second recipient 4 for urine is a delayed portion of urine from the human individual subject to urine collection and this delayed portion of urine represents and qualifies as being a midstream portion of urine which to the extent possible is free of any externally provided bacteria.

When collection of urine in the second recipient 4 for urine has begun, the urine collected therein will start dissolving the tube kink retaining element 74 holding the kink 72 of the first end 20 of the flexible tubing 70 of the conduit 16 implying unfolding the kink of the tubing 70.

Once dissolved, urine collected in the second recipient 4 for urine will, by the action of the vacuum present in the third recipient 14 for urine, be sucked into the third recipient for urine 14.

The third recipient 14 for urine may easily and conveniently be disconnected from the conduit 16 without exposing the urine collected therein for the environment.

Hereby a safe and easy collection of a midstream portion of urine from a human individual is accomplished which moreover excludes risk of external contamination with bacteria.

Fig. 1b is a schematic view illustrating the urine collection device of Fig. 1a, wherein the first recipient 2 for urine at least partly surrounds said second recipient 4 for urine, and wherein a urine retaining means 50 has been arranged between the first recipient 2 for urine and the second recipient 4 for urine. The urine retaining means 50 extends along the full circumference of the space between the first recipient 2 for urine and the second recipient 4 for urine. Hereby, the urine retaining means 50 defines a relative narrow passage for urine being present between the first recipient 2 for urine and the second recipient 4 for urine, in going from an area above said urine retaining means 50 to an area below said urine retaining means 50, and vice versa.

This has the consequence that a first stream of urine, upon being collected in the first recipient 2 for urine, will be less prone to enter the second recipient 4 for urine once the level of urine rises in the first recipient 2 for urine.

In other words, as the level of urine rises in the first recipient 2 for urine the urine retaining means 50 aids in preventing urine which has entered the first recipient for urine below the

DK 181609 B1 18 horizontal level of the urine retaining means 50, and hence comprising a first stream of urine, will be less likely to flow to a horizontal level above the urine retaining means 50, whereas a subsequent stream of urine, which enters the first recipient for urine when the level of urine is above the horizontal level of the urine retaining means 50, will be able to flow into the first recipient for urine. Thereby, a midstream of urine can be collected in the second recipient 4 for urine.

Fig. 1c is a cross-sectional view illustrating the first recipient for urine 2. It is seen that the second recipient for urine 4 is arranged within the first recipient for urine and that a space thereby is being defined between an inner surface of the first recipient for urine 2 and an outer — surface of the second recipient for urine 4.

This space has been provided with a number of baffles 48, which furthermore aids in retaining a first stream of urine in the first recipient 2 for urine, thereby minimizing the amount of a first stream of urine which enters the second recipient 4 for urine.

Fig. 1d is a schematic view illustrating the urine collection device of Fig. 1a, wherein the urine diverting means 5 is in the form of a moist soluble membrane 6 covering an upper opening 8 of the second recipient 4 for urine.

A part of the perimeter 10 of this moist soluble membrane 6 defines an entry 12 into the first recipient 2 for urine.

By virtue of the presence of the moist soluble membrane 6, urine being led to the urine — collection device 100 will hit the membrane 6 and be diverted to the entry 12 of the first recipient for urine 2.

However, this complete diversion of urine to the first recipient 2 for urine will only take place as long as the moist soluble membrane 6 remains intact. As the membrane 6 is moist soluble, the moist soluble membrane 6 will eventually dissolve by contact with the urine, whereafter a — continued stream of urine will be directed through the opening 8 of the second recipient 4 for urine and into the interior of this recipient.

Fig. le illustrates the embodiment of fig. 1d with the exception that the upper opening 8 of said second recipient 4 for urine is being arranged below an upper rim 54 of the first recipient 2 for urine.

Fig. 1fis a schematic view illustrating the urine collection device of Fig. la wherein the urine diverting means 5 is in the form of a canopy 7.

The canopy 7 is being positioned above an upper opening 8 of the second recipient for urine 4,

Furthermore, the canopy 7 is covering the upper opening 8 of the second recipient 4 for urine, thereby preventing urine form entering said second recipient for urine 4 from above, yet allowing subsequent urine to enter said second recipient for urine 4 from below, as described above with reference to Fig. la.

DK 181609 B1 19

Accordingly, in order for urine to enter the second recipient 2 for urine in the embodiment illustrated in Fig. 1f, urine will first have to flow into the first recipient 2 for urine as illustrated by the arrow 12, as the level of urine rises in the first recipient 2 for urine, a subsequently added portion of urine will be able to follow the arrow 52 and flow into the — second recipient 4 for urine.

The first recipient 2 for urine may be in the form of a container as illustrated in fig. 1.

Alternatively, this first recipient 2 may alternatively be in the form of or additionally comprise a urine absorbing material, such as a spongy material.

This is further illustrated in Fig. 2 and 3.

Fig. 2 is a perspective view illustrating an embodiment of the urine collection device according to the first aspect of the present invention. Fig. 3 is a cross-sectional view of this embodiment. In fig. 2 and 3 the urine diverting means 5 is in the form of a moist soluble membrane covering the upper opening of second recipient 4 for urine.

Fig. 2 and 3 show the device 100 comprising a first recipient 2, a second recipient 4 and a — third recipient 14, wherein a conduit 16 in the form of a tube is connecting the interior of the second recipient 4 for urine with the interior of the third recipient 14 for urine.

Again, the second recipient 4 for urine is at an upper opening thereof covered by a moist soluble membrane 5,6, and again the opening 18 in first end 20 of the conduit 16 is provided with a moist soluble tube kink retaining element 74.

Inthe embodiment illustrated in fig. 2 and 3 the first recipient 2 for urine comprises a urine absorbing material 28 in the form of a spongy material or cellulose fibers, such as paper fibers. Accordingly, instead of the situation where a first stream, or forestream, of urine is collected in a container, in the embodiment illustrated in fig. 2 and 3 the forestream of urine is merely absorbed by a spongy material 28 surrounding the moist soluble membrane 5, 6 covering the second recipient for urine.

In the embodiment illustrated in fig. 2 the first recipient 2 for urine comprises a cover 42 comprising a number of perforations 44 therein. The cover 42 is covering an upper opening of the first recipient 2 for urine. Thereby it can be avoided that urine, once collected in the first recipient 2 for urine, subsequently will migrate into the second recipient 4 for urine. Also seen inthe embodiment illustrated in fig. 2 and 3 is the flow guide 32 comprising an upper rim 38.

This flow guide aids in directed a flow of urine to the opening of the upper parts of the first recipient 2 for urine and the second recipient for urine 4, respectively.

The materials used in the manufacture of the urine collection device 100 according to the first aspect of the present invention may be selected form materials usually employed in the field of urology, such as polyethylene, polypropylene, polyvinyl chloride etc.

Evacuated containers, which have proven suitable for us as the third recipient 14 for urine, in the urine collection device according to the first aspect of the present invention are

DK 181609 B1 20 commercially available. An example of such a commercially available vacuum container is the product “Monovette” manufactured by SARSTEDT.

The flexible tubing used for forming the kink 72 is suitable a PE Connection tube (1.0 x 2.0 mm), available from MPH Medical Devices s.r.o, Prelouc, Czech Republic. — This tube is capable of automatically unfolding to an un-kinked state once, the tube kink retaining element has been dissolved. Many other types of tubing will be suitable as well.

In an alternative embodiment the third recipient 14 for urine comprises a container which is a non-evacuated container, but is a container, which configured for becoming evacuated by being in fluid connection with a vacuum pump.

Accordingly, in this embodiment, by activating the vacuum pump, either before or after midstream urine has been collected in the second recipient 4 for urine, the midstream portion of urine can be transferred to the third recipient for urine by evacuation of that container.

The embodiment of the urine collection device 100 according to the first aspect of the present invention as illustrated in fig. 2 and 3 is suitable for being used in a wearable device. Hereby the invention according to the second aspect of the present invention is attained.

This is further illustrated in fig. 5 as disclosed below.

Fig. 5 shows a wearable device 200 for collecting urine from a human individual. The wearable device comprises a urine collecting device 100 according to the first aspect of the present invention. In fig. 5 the embodiment of the urine collection device corresponds to the device 100 illustrated in fig. 2 and 3.

The wearable device 200 illustrated in fig. 5 comprises a material 201 having an inner surface 202 configured to face a lower portion of the pelvic region of a human individual, and an — outer surface 204 arranged opposite to the inner surface.

On the inner surface 202 is arranged a water impermeable lining 206. This lining directs urine to the upper parts of the first recipient 2 for urine and the second recipient for urine 4, respectively, thereby leading urine, being present at the inner surface 202 of the material 201 of the device 200, to the urine collection device 100. — As seen in fig. 5 the upper rim 38 of the flow guide 32 of the urine collection device 100 is attached to a hole 208 in the material 201 in such a way that the flow guide 32 of the urine collection device 100 is arranged at a lower portion of said wearable device and in such a way that that the first recipient 2 for urine, the second recipient 4 for urine and the third recipient 14 for urine are arranged opposite to the inner surface 202 of said wearable device, that is outside the wearable device when being worn by a human individual.

The wearable device may be in the form of a diaper or a panty, such as a disposable panty.

DK 181609 B1 21

Arranging the third recipient 14 opposite to the inner surface 202 of the material 201 of the wearable device 200 allows for easy detection of delivery of urine from the individual.

Fig. 4a is a cross-sectional view of an alternative embodiment of the urine collection device illustrated in fig. 2 and 3. Fig. 4b is an exploded view of the urine collection device illustrated infig. 4a.

Fig. 4a and 4b illustrates a urine collection device in essence of similar design as the urine collection device illustrated in the Fig. 2 and 3.

Accordingly, the urine collection device 100 shown in Fig. 4a and 4b comprises a first recipient 2 for urine, a second recipient for urine 4 and a third recipient for urine 14. As in fig. 3 and 3 the urine collection device is provided with a flow guide 32 for urine which comprises an upper rim 38.

The upper rim 38 of the flow guide 32 is attached to an adhesive collar 210.

The adhesive is applied to the upper surface of the collar and thereby allows the collar 210 and accordingly the whole device 100 to be adhered to the skin of a human individual, and thereby enclosing the genitals of the individual.

In this way the urine collection device may be worn by a human individual without the necessity of being part of a panty or a diaper.

Also seen in fig. 4a and 4b is that the urine collection device is provided with a combined sensor and transmitter 45. The combined sensor and transmitter is in this embodiment arranged in the second recipient for urine 4 and thereby allows for sensing the appearance of a situation in which urine is being collected in the second recipient 4 for urine. This information may be sent by the transmitter of the combined sensor and transmitter to a central receiver which subsequently will alert hospital personnel that urination by the individual has taken place. — Such combined sensors and transmitters are commercially available under the generic term “sensor tags”. The company AMS markets a single chip RFID data logger under the model

No. SL900A. This data logger provides for measuring and transmitting a sensed temperature.

The urine collection device 100 illustrated in fig. 4a and 4b also comprises an overflow outlet 46 situated in an upper part of the flow guide 32.

In this way, excessive urine may exit the interior portion of the flow guide and flow through this outlet 46 into a diaper worn by the individual in addition to the device 100.

As it appears from the above sections, the urine collection device 100 when provided with a flow guide 32 and an adhesive collar 210 may be used as a stand-alone device; and alternatively, may be used in combination with a panty, such as a disposable panty or with a diaper.

DK 181609 B1 22

Fig. 6a, 7a, 8a, 9a are drawings which illustrate suitable geometries of the tube kink retaining element, and Fig. 6b, 7b, 8b, 9b and 10 are drawings illustrating the way in which such tube kink retaining element may retain the flexible tubing 70 in a kink configuration.

Fig. 6a shows the tube kink retaining element 74 in the form of a closed-looped ring 78. The — closed-lopped ring 78 comprises two inner opposing surface portions 76a,76b which may abut the outer surface of the flexible tubing 70 when this tubing has been bend into a kink 72 as shown in Fig. 6b.

In practice of the present invention, it has been found that so-called PVA straws which can be cut into smaller rings are excellent for use as the tube kink retaining element 74. Such PVA straws are available in tackle shops. See for example the following website: https://gardnertackle.co.uk/product/pva-booms/

Fig. 7a shows the tube kink retaining element 74 in the form of a closed-looped string 78 with a knot. Again, the closed-lopped string 80 comprises two inner opposing surface portions 76a,76b which may abut the outer surface of the flexible tubing 70 when this tubing has been bend into a kink 72 as shown in Fig. 7b.

Fig. 8a shows the tube kink retaining element 74 in the form of an open-looped clip 82. The open-lopped clip 82 comprises the two inner opposing surface portions 76a,76b which may abut the outer surface of the flexible tubing 70 when this tubing has been bend into a kink 72 as shown in Fig. 8b.

Fig. 9a shows the tube kink retaining element 74 in the form of a helix 84. The helix 84 comprises the two inner opposing surface portions 76a,76b which may abut the outer surface of the flexible tubing 70 when this tubing has been bend into a kink 72 as shown in Fig. 9b.

In Fig. 6b, 7b, 8b and 9b it is seen that the kink 72 of the flexible tubing 70 divides the flexible tubing 70 into a first portion 86a comprising the opening 18 and into a second portion 86b which is being in fluid connection with the third recipient 14 for urine. The tube kink retaining element 74 touches a first area on the outside surface of the first portion 86a as well as a second area on the outside surface of the second portion 86b of said flexible tubing 70.

Finally, Fig. 10 shows the tube kink retaining element 74 in the form of a moist-soluble glue 85. It is seen that the moist-soluble glue 85 adheres to the first portion 86a as well as the second portion 86b of the flexible tubing 70.

It should be noted that other geometries and designs of the of the tube kink retaining element 74 than those disclosed in the present application are possible and a person skilled in the art will be able to come up with other such designs and geometries.

DK 181609 B1 23

Fig. 11 shows the first part 300 of a urine collection device 100. The urine collection device 100 also comprises a second part 302, which is not illustrated in Fig. 11. The second part of said urine collection device comprises the third recipient 14 for urine.

The first part of the urine collection device comprises said first recipient 2 for urine, said — second recipient 4 for urine and said urine diverting means 5.

The part 300 of said urine collection device is being in the form of a wearable device adapted to be worn by a female human being and configured to be held in place between the labia majora of that female human being.

It is seen in Fig. 11 that the first recipient 2 for urine is being arranged below said second recipient 4 for urine.

As seen in Fig. 11, the first recipient 2 for urine is being separated from the second recipient 4 for urine by a wall element 304, and that wall element comprises an upwardly extending, hollow protrusion 306.

The urine diverting means 5 is being in the form of a funnel like structure comprising an — upper flow guide 32 and a lower hollow stem 308, and as seen the urine diverting means 5 is covering the second recipient 4 for urine.

The hollow stem 308 of the urine diverting means 5 is being accommodated in the upwardly extending, hollow protrusion 306 of the wall element 304.

The geometry and dimensions of the upwardly extending, hollow protrusion 306 and of the hollow stem 308 of the urine diverting means 5, respectively, are adapted to each other in such a way that a free space 310 is present between an outer surface 312 of the hollow stem 308 and an inner surface 314 of the hollow protrusion 306, thereby allowing midstream urine to flow from said first recipient 2 for urine to said second recipient 4 for urine via said free space 310.

Itis seen that the first part 300 the urine collection device illustrated in Fig. 11 comprises an opening 316 for entry of the conduit 16 into the second recipient 4 for urine, and that this conduit 16 is arranged in this opening 316.

It is also seen that the first recipient 2 for urine comprises a urine absorbing material 28, such as a spongy material or a fibrous material, such as cellulose, such as cotton fiber or paper, and that the urine absorbing material 28 is being arranged below the hollow stem 308 of the urine diverting means 5.

Also seen in Fig. 11 is that the second recipient 4 for urine comprises an overflow opening 318 for allowing urine to exit said second recipient 4 for urine, such as into a diaper worn by said female human being.

DK 181609 B1 24

Finally, Fig. 11 shows that an upper portion 320 of the first part 300 of the urine collection device comprises a surrounding outwardly extending rim 322 which is configured to enter into engagement with part of the labia majora of that female human being upon use.

In use, the urine collection device of Fig. 11 is arranged between the labia majora of a female user in an orientation where, when the female is standing upright, the second recipient 4 for urine is being arranged above the first recipient for urine 2.

In this position, when the female user urinates, the urine diverting means 5 in the form of the flow guide 32 directs the urine into the first recipient for urine 2 via the hollow stem 308.

Once reaching the first recipient for urine 2, the urine absorbing material 28 will absorb the first or forestream portion of urine (which is not midstream urine). When more urine enters the first recipient for urine 2, the level of the urine will rise and enter the interior of the hollow protrusion 306, thereby entering the second recipient for urine 4.

When urine is present in the second recipient for urine 4, it will dissolve the tube kink retaining element 74, which in turn will imply that the area of the kink 72 of the tubing 70 — will stretch out, thereby allowing the urine being present in the second recipient for urine 4 to be sucked into the third recipient for urine 14.

It should be understood that all features and achievements discussed above and in the appended claims in relation to one aspect of the present invention and embodiments thereof apply equally well to the other aspects of the present invention and embodiments thereof.

DK 181609 B1 25

List of reference numerals 2 First recipient for urine 4 Second recipient for urine

Urine diverting means 5 6 Moist soluble membrane 7 Canopy 8 Upper opening of second recipient for urine

Perimeter of moist soluble membrane 12 Entry into first recipient for urine 10 14 Third recipient for urine 16 Conduit 18 Opening in first end of conduit 20 First end of conduit 22 Opening in second end of conduit 24 Second end of conduit 28 Urine absorbing material 32 Flow guide 38 Upper rim of flow guide 40 Lower portion of second recipient for urine 42 Cover of first recipient for urine 44 Opening in entry into first recipient for urine 45 Sensor and transmitter, such as RFID 46 Overflow outlet 47 Support for urine absorbing material 48 Baffle

Urine retaining means 52 Access for urine into second recipient for urine

DK 181609 B1 26 54 Upper rim of first recipient for urine 70 Flexible tubing 72 Kink of flexible tubing 74 Tube kink retaining element 76a,76b Inner opposing surface portions 78 Tube kink retaining element in the form of a closed-looped ring 80 Tube kink retaining element in the form of a closed-lopped string 82 Tube kink retaining element in the form of an open looped clip 84 Tube kink retaining element in the form of a helix 85 Moist-soluble glue 86a First portion of flexible tubing 86b Second portion of flexible tubing 88a First area on outside surface of first portion of flexible tubing 88b Second area on outside surface of second portion of flexible tubing 100 Urine collection device 200 Wearable device 201 Material of wearable device 202 Inner surface of wearable device 204 Outer surface of wearable device 206 Water impermeable lining 208 Hole in material of wearable device 210 Adhesive collar 300 First part of urine collection device 302 Second part of urine collection device 304 Wall element of first part of urine collection device 306 Hollow protrusion of wall element 308 Hollow stem of flow guide

DK 181609 B1 27 310 Free space 312 Outer surface of hollow stem 314 Inner surface of hollow protrusion 316 Opening for conduit 318 Overflow opening 320 Upper portion of first part of urine collection device 322 Outwardly extending rim

U Stream of urine

Claims

DK 181609 B1 28 Patent claim

1. Urine collection device (100) for collecting midstream urine; where the device in the orientation intended during urine collection comprises: - a first receiving container (2) for urine; -a second receiving container (4) for urine; -urinary diversion agents (5); wherein the urine collection device (100) comprises a third urine receiving container (14), wherein the third urine receiving container (14) comprises an evacuated container, or wherein the third urine receiving container (14) comprises a container configured to be evacuated by being in fluid communication with a vacuum pump; wherein the urine collection device comprises a channel (16) having an opening (18) at a first end (20) and an opening (22) at a second end (24) thereof; wherein the first end (20) of the channel (16) is arranged in the interior of the second receiving container (4) for urine; — where the opening (22) at the other end (24) of the channel (16) is in fluid communication with the interior of the third receiving container (14) for urine; characterized in that the first end (20) of the channel (16) comprises a flexible hose (70) which is bent so as to comprise a hose kink (72); wherein the hose kink (72) is held in place by a hose kink retaining element (74), wherein the hose kink retaining element — (74) is made of a moisture soluble material, the hose kink thereby blocking a vacuum present in the third receiving container (14) until dissolution of the moisture-soluble material and subsequent unfolding of the flexible hose (70) in the hose clamp (72).

2. Urine collection device (100) according to claim 1, wherein the urine diverting means (5) are — configured to divert a first portion of urine, which is guided from above to the position of the urine diverting means (5), to enter the first receiving container (2) for urine; and which is configured to drain a subsequent portion of urine, which is directed from above to the position of the urine diverting means (5), to enter the second receiving container (4) for urine.

3. Urine collection device (100) according to claim 1 or 2, wherein the urine diversion means (5) are — positioned at or above an upper opening (8) of the second receiving container (4) for urine.

A urine collection device (100) according to any one of the preceding claims, wherein the urine diversion means (5) comprises a moisture soluble membrane (6); wherein the moisture soluble membrane (6) covers an upper opening (8) of the second receiving container (4) for urine;

DK 181609 B1 29 wherein at least part of the circumference (10) of the moisture soluble membrane defines an entrance (12) into the first receiving container for urine.

5. Urine collection device (100) according to any one of claims 1 - 3, wherein the urine diversion means (5) comprise a cap covering an upper opening (8) of the second receiving container (4) for urine, whereby urine is prevented from to enter the second receiving container (4) for urine from above, but which nevertheless enables subsequent urine to enter the second receiving container (4) for urine from below.

6. Urine collection device (100) according to claim 4, wherein the moisture-soluble membrane (6) is made of a material independently selected from the group comprising: polyvinyl alcohol, polyvinyl pyrrolidone, alginate, polyacrylamide.

Urine collection device (100) according to any one of the preceding claims, wherein the first receiving container (2) for urine at least partially surrounds the second receiving container (4) for urine.

8. Urine collection device (100) according to claim 7, wherein one or more substantially vertically oriented baffles (48), such as 2-24 baffles, are arranged between the first receiving container (2) for urine and the second receiving container (4) for urine.

9. Urine collection device (100) according to claim 7 or 8 further comprising one or more urine retention means (50) arranged between the first receiving container (2) for urine and the second receiving container (4) for urine, preferably along their full circumference, where — the urine retention means (50) define a relatively narrow passage for urine between the first urine receiving container (2) and the second urine receiving container (4) when going from an area above the urine retention means (50) to an area below the urine retention means (50) , and the other way around.

10. Urine collection device (100) according to any one of the preceding claims, wherein — the upper opening (8) of the second receiving container (4) for urine is arranged below an upper edge (54) of the first receiving container for urine,

11. Urine collection device (100) according to any one of the preceding claims, wherein the urine holding capacity of the first receiving container (2) for urine and/or the second receiving container (4) for urine, and/or the third receiving container (14) is independently in — the range 50 — 250 ml.

A urine collection device (100) according to any one of the preceding claims, wherein the channels (16) comprise a valve, such as a non-return valve, for preventing urine from flowing in one direction from the third urine receiving container (14) to the second receiving container (4) for urine. — 13. A urine collection device (100) according to any one of the preceding claims, wherein the interior of the third urine receiving container (14) comprises a vacuum of 600 mm Hg or less, such as 500 mm Hg or less, e.g. 450 mm Hg or less, such as 400 mm Hg or less, e.g. 350 mm Hg or less, such as 300 mm Hg or less, for example

DK 181609 B1 30 250 mm Hg or less, e.g. 200 mm Hg or less, such as 150 mm Hg or less, for example 100 mm Hg or less, or 50 mm Hg or less.

Urine collection device (100) according to any one of the preceding claims, wherein the urine diversion means (5), when viewed from the outside of the second receiving container (4), and preferably from above, define a convex cover.

15. Urine collection device (100) according to any one of the preceding claims, wherein the third receiving container (14) for urine is previously sterilized.

A urine collection device (100) according to any one of the preceding claims, wherein the first end (20) of the channel (16,70) is arranged in the interior of the second receiving container — (4) for urine at a lower part thereof .

A urine collection device (100) according to any one of the preceding claims, wherein the third receiving container (14) for urine comprises an evacuated container.

A urine collection device (100) according to any one of the preceding claims, wherein the third receiving container (14) for urine comprises a container configured to be — evacuated by being in fluid communication with a vacuum pump.

19. Urine collection device (100) according to any one of the preceding claims, wherein the third receiving container (14) for urine is made of a transparent or transparent material, whereby visual detection of completion of collection of a portion of mid-stream urine is thereby enabled.

A urine collection device (100) according to any one of the preceding claims, wherein the third receiving container (14) for urine comprises a leak-proof coupling, such as a quick coupling for coupling and disconnecting the channel.

A urine collection device (100) according to any one of the preceding claims, wherein the urine collection device is packaged in a sealed package, such as a sterilized, — sealed package.

A urine collection device (100) according to any one of the preceding claims, wherein the first receiving container (2) for urine comprises a urine absorbent material (28), such as a spongy material or a fibrous material such as cellulose, such as cotton fibers or paper.

23. Urine collection device (100) according to any one of the preceding claims, wherein — the hose kink retaining element (74) is made of a moisture-soluble material selected from the group comprising: synthetic polymers such as polyvinyl alcohol, polyacrylamide, polyvinylpyrrolidone, polyacrylic acid, methyl cellulose, hydroxyethyl cellulose; or non-synthetic polymers such as alginate, guar gum, gelatin, xanthan gum.

A urine collection device (100) according to any one of the preceding claims — further comprising a flow guide (32) for directing urine flowing or falling via

DK 181609 B1 31 the gravitational acceleration, to an upper part of the first and/or the second receiving container for urine; in that this flow guide comprises an upper edge (38).

25. Urine collection device (100) according to claim 24, wherein the upper edge (38) of the flow guide is provided with an adhesive collar, thereby enabling the urine collection device to adhere to the skin of a human individual.

A urine collection device according to any one of the preceding claims, wherein the channel (16) at least partially comprises a flexible tube.

Urine collection device (100) according to any one of the preceding claims, wherein the first receiving container (2) for urine comprises a cover (42) which partially covers the entrance (12) in the first receiving container for urine, such as by being provided with one or more openings (44), such as in the form of one or more holes, perforations or slits.

28. Urine collection device (100) according to any one of the preceding claims further comprising one or more RFID tags for identifying the identity of the collected urine.

29. Urine collection device (100) according to any one of the preceding claims, further comprising one or more sensors (45), such as motion sensor(s), temperature sensor(s), humidity sensor(s), optionally coupled to a transmitter which is contained in the device, for the transmission of data collected by one or more such sensors to a central receiver, the sensor and/or the transmitter possibly being in the form of a — RFID data logger.

Urine collection device (100) according to any one of the preceding claims, wherein the hose kink (72) divides the flexible hose (70) into a first part (86a) comprising the opening (18) and a second part (86b) which is in fluid communication with the third receiving container (14) for urine; wherein the hose kink retaining member (74) contacts a first area (88a) on the outer surface of the first part (86a) as well as a second area (88b) on the outer surface of the second part (86b) of the flexible hose (70) .

A urine collection device (100) according to claim 30, wherein the hose kink retaining member (74) is in the form of a hardened moisture soluble adhesive (85), such as PVA glue, wherein the moisture soluble adhesive is attached to the first region (88a) as well as to the second area (88b).

A urine collection device (100) according to any one of the preceding claims, wherein the hose kink retaining element (74) comprises two inner, opposite surface portions (76a, 76b) having geometries, dimensions and mutual distances adapted to the geometry and dimensions of the flexible hose (70) in order to maintain the kink (72) of the flexible hose (70).

A urine collection device (100) according to any one of the preceding claims, wherein the hose kink retaining element (74) is in the form of a closed loop ring (78), a closed loop cord (80), an open loop clip (82 ), such as a U-shaped clip or spiral (84).

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34. Urine collection device (100) according to any one of the preceding claims, wherein the flexible hose (70) is made of a polymer, such as a thermoplastic elastomer, such as polyethylene, polypropylene, polyvinyl chloride, silicone, polyurethane, ethylene vinyl acetate, fluorinated derivatives or co-polymers of any of these.

A urine collection device (100) according to any one of the preceding claims, wherein the flexible tube (70) is an elastic flexible tube.

36. Urine collection device (100) according to claim 1, wherein the urine collection device (100) comprises a first part (300) and a second part (302), wherein the first part of the urine collection device comprises the first receiving container (2) for urine, the second receiving container ( 4) for urine and the urine diversion agents (5); and wherein the second part (302) of the urine collection device comprises the third receiving container (14) for urine; wherein the first portion (300) of the urine collection device is in the form of a body-worn device adapted to be worn by a female and configured to be held in place between the female's labia majora; — where the first receiving container (2) for urine is arranged below the second receiving container (4) for urine; wherein the first receiving container (2) for urine is separated from the second receiving container (4) for urine by a wall element (304), the wall element comprising a hollow projection (306) which extends upwards; — wherein the urine diverting means (5) is in the form of a funnel-like structure comprising an upper flow guide (32) and a lower hollow stem (308), and wherein the urine diverting means (5) covers the second receiving container (4) for urine; wherein the hollow stem (308) of the urine diverting means (5) is housed in the hollow projection (306) of the wall member (304) which extends upwards; > where the geometry and dimensions of the hollow protrusion (306) which extends upwards, and of the hollow stem (308) of the urine diverting means (5) are adapted to each other in such a way that a free space (310) is present between an outer surface (312) of the hollow stem (308) and an inner surface of the hollow projection (306), thereby enabling midstream urine to flow from the first urine receiving container (2) to the second receiving container (4) for urine via this free space (310); where the first part (300) of the urine collection device comprises an opening (316) for introducing the channel (16) into the second receiving container (4) for urine, and where the channel (16) is arranged in this opening (316).

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37. Urine collection device (100) according to claim 36, wherein the first receiving container (2) for urine comprises a urine absorbent material (28), such as a spongy material or a fibrous material, such as cellulose, such as cotton fiber or paper, wherein the urine absorbent material (28 ) is optionally arranged under the hollow stem (308) of the urine diversion means (5).

38. Urine collection device (100) according to claim 36 or 37, wherein the second receiving container (4) for urine comprises an overflow opening (318) to enable urine to flow out of the second receiving container (4) for urine, such as into a diaper worn by the woman.

39. Urine collection device (100) according to any one of claims 36 - 38, wherein the extent in a longitudinal direction X of the first part (300) of — the urine collection device is selected from the ranges of 40 — 85 mm, such as 45 — 80 mm,

eg. 50 — 75 mm, such as 55 — 70 mm or 60 — 65 mm; and/or wherein the extent in a transverse direction Y of the first part (300) of the urine collection device (100) is selected from the ranges 22 — 48 mm, such as 24 — 46 mm, for example 26 — 44 mm, such as 28 — 42 mm, such as 30 — 40 mm, for example 32 — 38 mm or 34 — 36 mm; and/or where — the extent in a height direction Z of the first part (300) of the urine collection device (100) is selected from the ranges of 22 — 48 mm, such as 24 — 46 mm, for example 26 — 44 mm,

eg. 28 — 42 mm, for example 30 — 40 mm, e.g. 32 — 38 mm or 34 — 36 mm.

40. Urine collection device (100) according to any one of claims 36 - 39, wherein an upper part (320) of the first part (300) of the urine collection device comprises an at least partially surrounding outwardly extending edge (322) which is configured to be able, in use, to engage with a portion of the labia majora of the woman, where the edge (322) optionally has a thickness, as measured in a vertical direction Z, of 2 — 9 mm, such as 3 — 8 mm, for example 4 — 7 mm or 5 — 6 mm.

41. Urine collection device (100) according to claim 36 further comprising features as — defined in any one of claims 1 — 3, 5, 16, 22 — 24, 26 and/or 18 — 35.

42. A urine collection device (100) according to any one of claims 36-41, wherein the urine diversion means (5) of the first part (300) are removably attached to the second receiving container (4) for urine.

43. A body-worn device (200) for collecting urine from a human subject, wherein the — body-worn device comprises a urine collection device (100) according to any one of claims 1 — 35; wherein the body-worn device comprises a material (201) with an inner surface (202) which is configured to face at least a lower part of the pelvic region of a human subject, and an outer surface (204) which is arranged opposite the inner surface. 44 The body-worn device (200) according to claim 43, wherein the body-worn device, when worn by a human subject, is configured in such a way that the first receiving container (2) and the second receiving container (4) of the urine collection device are arranged at a lower part of the body-worn device.

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45. Body-worn device (200) according to claim 43 or 44, wherein the body-worn device, when worn by a human subject, is configured in such a way that the first receiving container (2) for urine, the second receiving container (4) for urine and the third — receiving container (14) is arranged opposite the inner surface of the body-worn device.

46. A body-worn device (200) according to any one of claims 43-45, wherein the body-worn device is packaged in a package, such as a sterilized, sealed package.

47. A body-worn device (200) according to any one of claims 43-46, wherein the body-worn device is in the form of a diaper or an underpants, such as a disposable underpants.

48. A body-worn device (200) according to any one of claims 43-47, wherein the inner surface (202) comprises a water impermeable lining (206).

49. The body-worn device (200) of any one of claims 43-48, wherein the urine collection device is as defined in claim 24, wherein the edge (38) of the flow guide is arranged at the inner surface (202) of the body-worn device. —

50. Use of the urine collection device (100) according to any one of claims 1-42, or of a body-worn device (200) according to any one of claims 43-49, for collecting midstream urine from a human subject.

51. Use according to claim 50, wherein the use includes wearing the urine collection device or the body-worn device by a human subject and — optionally further includes wearing a standard diaper.