Device for taking urine samples in women

Abstract

The present invention relates to a device which allows taking clean urine samples in women, i.e., urine samples not contaminated with fluids or contaminants found in close proximity to the urethra. This device is characterized by a specific configuration which allows samples to be taken without damaging the woman's skin and prevents contamination thereof in the sample-taking process. Other specific examples have additional advantages that are described hereafter.

Description

[0001] DEVICE FOR COLLECTING URINE SAMPLES IN WOMEN

[0002] DESCRIPTION

[0003] OBJECT OF THE INVENTION

[0004] The present invention is directed to a device that allows taking clean urine samples from women, in the sense of not being contaminated with fluids or contaminants that are very close to the urethra.

[0005] This device is characterized by a specific configuration that allows for sample collection that doesn't damage the woman's skin and prevents contamination during the sample collection process. Other specific examples have additional advantages, which are described later.

[0006] BACKGROUND OF THE INVENTION

[0007] Collecting clean urine samples from women for subsequent laboratory testing is a complicated and often invasive task, causing wounds, irritation, or both.

[0008] Sampling in hospitalized women is often performed using catheters. The insertion of the catheter, although the surfaces and tip are blunt, impacts and passes with friction through a thin passage, especially in older women with very thin and delicate skin.

[0009] Although the catheter allows urine to be extracted, it must then be transferred to a container suitable for transport to the laboratory.

[0010] Another way to collect a urine sample is by using a container with the woman bedridden. In this position, the urethra is in a superior position, protected by the labia minora, with the vagina and anus very close. All of this makes it necessary to achieve greater accessibility, and the expelled urine is not contaminated when it descends and comes into contact with either the external area of ​​the vagina or the anus. The device of the present invention effectively overcomes these drawbacks.

[0011] DESCRIPTION OF THE INVENTION

[0012] The present invention is a device for collecting urine samples from women. The device comprises: a main body formed by a container accessible through a mouth, and a lid adapted to close the mouth of the main body.

[0013] The device consists of two parts: the main body and the lid. The main body has a mouth and what we'll call the container, the mouth, to allow urine to enter the container and isolate it from potential contaminants.

[0014] While the device can be positioned in any position and orientation in space, under operating conditions, the woman lies face up, for example, in a hospital bed, and a urine sample is collected with her urethra accessible. The device is positioned appropriately according to how her anatomy is exposed near the urethra. These conditions will be identified throughout the description when referring to "operational mode."

[0015] In this position, where the woman is lying on her back, the urethra is at its highest point, and the vagina is located farther away, albeit at a lower height. Urine discharge in these conditions would descend, becoming contaminated by the vagina and, later, even by the anal region, invalidating the urine sample. This is the order described because it is the anatomical order found when descending in height and, therefore, the path that urine would follow under the action of gravity.

[0016] The area of ​​skin between the urethra and the vagina is flanked by the labia minora. Once the labia minora are separated by the nurse in charge of collecting the sample, their tendency to close helps keep the device in the proper position, preferably even remaining partially or fully adhered to the outer surface of the device, thus establishing a tight seal that prevents urine from running down the outside of the device and entering the container through the mouth.

[0017] That is, the mouth of the device completely intercepts the urine outlet so that it enters the device without becoming contaminated.

[0018] According to preferred examples of the invention, they provide a device design such that, in operating mode, it extends in the area of ​​the vulva between the exit of the urethra, preferably slightly distanced from it and without touching it, to the perineum.

[0019] The tightness conditions with the woman's skin and the protection achieved against harm are the result of its configuration, which is described below.

[0020] As described, the mouth of the device is the one that, in operational mode at the time of taking the sample, is located next to the urethra, positioning it at the bottom following the direction of the action of gravity when the woman is lying on her back.

[0021] The device is characterized in that: the container is extended to the mouth by means of a tubular section; the tubular section comprises a channel with a curved section that extends along a longitudinal direction X-X', at least in one section, where said channel is extended on both sides by two lateral flanks, a right flank and a left flank, both configured in a "V" shape to rest on the woman's skin between the labia minora; the channel is extended at its end opposite the mouth of the main body in a curved section, separating from the longitudinal direction X-X', to give rise to an expansion of the container.

[0022] According to this specific configuration, the container extends to the mouth through a tubular section that guides the urine entering the device's mouth into the container. This tubular section has a configuration specifically designed to fit the woman's urethral region, ensuring that the urine is not contaminated and, furthermore, without damaging the woman's skin.

[0023] The fact that it does not cause skin damage means that potential infections are eliminated and there is no pain, two of the great advantages of this device.

[0024] The tubular section is configured with a curved channel. In operation, the outer surface of the curved channel is the one that always comes into contact with the woman's skin, and during sample collection, it rests on the section between the urethra and the vagina. The curved section avoids sharp edges that could cause skin damage. Likewise, its curved shape creates a channel inside the container for urine conduction, which extends to the inside of the container.

[0025] This channel extends on either side by two lateral flanks, one on the right and one on the left, forming a "V" shape. That is, the two flanks converge at the curved channel, so the final configuration lacks the lower peak of the "V"; the channel is more like the bottom of a "U." These lateral flanks help both guide urine inward and keep the woman's labia minora separated, preventing contact with and contamination of urine. Contact between the device and the woman's skin creates a tight seal that prevents urine expelled through the urethra from leaking out of the device.

[0026] The urine must always travel by gravity until it reaches the container, and the container must be such that it not only accepts the liquid but also prevents it from escaping.

[0027] To this end, the channel's path in its extreme zone opposite the inlet is curved, deviating from the longitudinal direction XX established by the first section. This deviating direction generates an expansion of the vessel.

[0028] During urine sampling, when the channel is resting on the skin between the urethra and the vagina, the longitudinal direction XX' defined by the channel is downward, hence the urine entering through the mouth of the device has the tendency to enter and reach the inside of the container. However, any change in inclination could result in urine leaking out of the container, especially when it is being filled. To solve this problem, the device is configured to expand, resulting in a curved final section of the channel separating from the longitudinal direction X-X'.

[0029] According to the position and orientation references, the final curved section with a curvature that separates from the longitudinal direction XX' is a section that increases its inclination and the expansion of the container is placed in a lowered position. That is, this configuration allows, in the operative position, the expanded area of ​​the container to adhere to the woman's skin in regions close to the vagina or even exceeding the position of the vagina. In this position, the expanded part is placed in an even lower position, ensuring that urine does not leak out again.

[0030] Furthermore, the "V" shape of the side flanks, according to one embodiment, also extends into this expanded region, helping to keep the area accessible and protecting the captured urine from contamination.

[0031] According to an example of embodiment applicable to the described device, the mouth has a configuration of its perimeter edge contained in an inclined plane with respect to the plane perpendicular to the longitudinal direction XX' and, such that the region of the perimeter edge close to the channel is shown to be more distant from the container than the rest of the region of the perimeter edge.

[0032] According to this embodiment, the perimeter edge of the mouth is oblique, that is, it is not transverse to the longitudinal direction XX. This inclination exposes the mouth opening to the nurse in charge of taking the sample, facilitating visual access so that they are able to identify that the device is properly positioned.

[0033] According to this inclination, the part of the perimeter edge that corresponds to the channel is extended and is the one that rests adjacent to the urethra so that the tightness condition with the perimeter edge is established right next to the urethra and no urine can escape outside the device.

[0034] According to an embodiment applicable to the device described in any of the previous examples, the container comprises a flat base, adapted to support the device on the base in such a way that the longitudinal direction XX' has

[0035] Once the device has been used to collect a urine sample, the lid seals the device and it can be transported. The flat base provides stability to the device when used as a support surface. When the base is used as a support surface on a horizontal surface, the channel direction preferably adopts a vertical position, always taking horizontal and vertical references with respect to the direction of gravity. However, according to various embodiments of the invention, the channel orientation may show a certain inclination. The ranges described in square brackets [*] have the usual meaning in mathematics that uses this notation, where the extremes are considered to be included within the range, closed intervals, unlike curved brackets (*), where the extremes are not part of the interval, open ends.

[0036] The stability achieved with this configuration is high since the expansion increases the support area and leaves the mouth as far away as possible from the lower base, preventing the collected urine from being close to the closing region between the lid and the main body, even when the device is closed.

[0037] According to an embodiment applicable to the device described in any of the previous examples, the side flanks are flat.

[0038] According to this configuration, the flanks form two inclined planes that converge at the bottom of the channel. This allows the labia minora to remain open and separated during sample collection. The tendency of the labia minora to close facilitates their adherence and creates an adequate seal to prevent urine from leaking out of the device.

[0039] According to an embodiment applicable to the device described in any of the previous examples, a section of wall of the tubular section connects the lateral flanks at an end opposite the channel and is configured to form a curved surface with a curved arc section, the section according to a plane perpendicular to the longitudinal direction X-X'.

[0040] According to this embodiment, the lateral flanks close off the tubular section on the side opposite the curved arch channel. This creates a larger tubular section, facilitating urine entry. It also eliminates the presence of corners, creating a smooth exterior surface that prevents damage to the woman's skin.

[0041] According to an embodiment applicable to the device described in any of the previous examples, where the material of the main body is elastically deformable.

[0042] The use of an elastically deformable material has several important technical benefits. The first is that the shape of each woman's anatomy varies from one to another. Therefore, while the device's configuration optimizes intimate contact with the skin to ensure a tight seal, its ability to deform helps achieve maximum adaptation. As it is also elastically deformable, after sampling, the device adopts the shape defined during manufacturing, with the advantages described above.

[0043] The other effect is to reduce specific stresses when it comes into contact with the skin, since the material gives way and prevents damage.

[0044] According to an embodiment applicable to the device described in any of the previous examples, where the lid material is elastically deformable.

[0045] The use of an elastically deformable material in the lid also ensures a secure seal with the main body. When both are elastically deformable, the deformation of one is followed by the deformation of the other, thus improving the tightness between the two.

[0046] According to an embodiment applicable to the device described in either of the two previous examples, the material is silicone.

[0047] The use of silicone allows for a high degree of elastic deformation, making it very durable and preventing breakage during handling. Furthermore, it is an inert material, so the risk of allergies is greatly reduced.

[0048] According to an embodiment applicable to the device described in any of the previous examples, the lid is configured to externally embrace the mouth of the main body, establishing a seal between the mouth and the lid.

[0049] The perimeter edge of the main body is shaped to fit snugly against the skin, creating a tight seal, and it is this edge that primarily determines the most suitable shape. It has been proven that a closure with the lid externally hugging the mouth of the main body provides an adequate tight seal.

[0050] According to an embodiment applicable to the device described in any of the previous examples, where the perimeter edge of the mouth is thickened to increase resistance to deformation.

[0051] A thickened perimeter rim increases resistance to deformation without the need for a material change. Greater rim strength allows the bond with the skin near the urethra to at least slightly increase the bond strength, as this is the contact region where the tightness must be most necessary to prevent urine from leaking outside the container.

[0052] Additionally, this greater resistance also makes the subsequent connection to the lid more secure and watertight, since possible deformations could lead to separation between the surfaces that are in contact between the lid and the mouth of the device.

[0053] According to an embodiment applicable to the device described in any of the previous examples, where all edges are rounded.

[0054] This condition ensures that handling of the device at the time of sample collection, when the device comes into contact with the skin of the woman from whom the sample is to be taken, does not cause damage, even if at that time the device is not through the surfaces specifically designed to come into contact with the skin. This prevents any accidental damage, even if the device is oriented differently. According to an exemplary embodiment applicable to the device described in any of the previous examples, where the lid comprises one or more receptacles, adapted to house one or more test elements, preferably for determining the existence of infections, where the one or more receptacles are in fluid communication with the interior of the main body when the lid is closing the mouth of the device.

[0055] There are various test elements, mainly in the form of strips, that react upon contact with a sample, such as urine, and change their appearance depending on the object for which they are designed. These test strips include those that determine the presence of any type of infection or chemical properties such as pH. Changes in appearance include, for example, a change in color.

[0056] Before closing the lid on the device, the receptacles accommodate one or more test elements such that, when the mouth of the device is closed with the lid, the test elements are exposed to contact with the urine.

[0057] This allows for a quick check of whether the urine contains an infection, even before taking it to the laboratory for analysis, or for a measurement of the sample, determined by the type of test element inserted into the container.

[0058] According to an exemplary embodiment applicable to the device described in any of the previous examples, the lid comprises one or more regions comprising one or more test elements, preferably joined by adhesive.

[0059] In the previous example, the lid incorporates one or more receptacles. In this other example, compatible with the previous one, the test elements are attached to the lid without needing to change the lid's configuration. It is sufficient to have a reserved region to receive the test element. One of the preferred regions to serve as a region containing the test element is a portion of the inner area of ​​the lid, the area that comes into contact with the urine when it closes the mouth of the device.

[0060] A preferred way to include these test elements in the lid regions is by means of an adhesive. According to an exemplary embodiment applicable to the device described in any of the previous examples that include a test element, these test elements are dry chemical elements, preferably sections of strips.

[0061] Dry chemistry strips are commonly used for rapid testing in open containers. In this case, the addition of a dry chemistry element attached to the lid means that the device itself, when in use, requires no additional intervention. Once closed, the urine collection process provides the initial result from the test element(s).

[0062] According to an exemplary embodiment applicable to the device described in any of the previous examples that include a test element, the test elements are adapted to identify at least the presence of:

[0063] - nitrites;

[0064] - leukocytes;

[0065] - hematuria;

[0066] - proteins;

[0067] - a combination of any of the above.

[0068] While it is possible to include more test elements, this selection is considered to allow for advanced understanding of some of the most relevant results regarding women's health.

[0069] According to an exemplary embodiment applicable to the device described in any of the previous examples, where the lid, the main body or both are transparent to allow visual access to changes in the appearance of the test strips.

[0070] When the test element reacts upon contact with the urine sample, a visually perceptible change occurs. If one or both elements, the main body or the lid, are transparent, this visual change can be observed without having to open the lid. Opening the lid before analysis can cause the entry of contaminants that could distort or even invalidate the subsequent laboratory test.

[0071] DESCRIPTION OF THE DRAWINGS These and other features and advantages of the invention will become more clearly apparent from the following detailed description of a preferred embodiment, given solely by way of illustrative and non-limiting example, with reference to the accompanying figures.

[0072] Figure 1 This figure shows a perspective view of a preferred embodiment of the invention. The view shows the main body and, with lines, the lid is represented in a transparent mode to allow simultaneous viewing of the perimeter edge of the device's mouth.

[0073] Figure 2 This figure shows the side of the device according to the same embodiment when it is with the base resting on a horizontal surface, for example, after taking a sample.

[0074] Figure 3 This figure shows a perspective view of the same embodiment where the orientation of the device is such that the interior of the main body can be observed.

[0075] DETAILED EXPLANATION OF THE INVENTION

[0076] The present invention is a device for taking urine samples from women, a preferred example of which is shown in Figures 1 to 3.

[0077] The preferred example is a device made of an elastically deformable material having the shape shown in the figures.

[0078] Figure 1 shows the main body (1) with the cover (2) displayed with lines, but in transparent mode, that is, in addition to the cover (2) the perimeter edge (1.2.1) of the mouth (1.2) for access to the interior of the main body (1) is also shown.

[0079] The orientation chosen in this figure is close to the orientation that the main body (1) has at the time of the sample.

[0080] Considering the orientation shown in this same figure 1, the perimeter edge (1.2.1) of the mouth (1.2) of the main body (1) is shown on the left and gives access to the interior of the main body (1) on which a larger volume area can be distinguished on the right and which we identify as container (1.1). We call it container (1.1) since it is intended to hold the collected urine sample inside.

[0081] Between the mouth (1.2) and the container (1.1) there is a tubular section (1.3) that acts as the neck of the container (1.1).

[0082] Continuing the description from the elements on the left to those on the right, it can be seen that the perimeter edge (1.2.1) of the mouth (1.2) is thickened and has a teardrop shape. That is, the lower part has a "V" shape with a rounded peak to avoid creating sharp edges. It extends upwards in straight sections until they end connected by an arch. This configuration is shown more clearly in Figure 3.

[0083] Returning to Figure 1 by the orientation shown, it can be seen how the entire perimeter edge of the mouth (1.2) is contained in a plane identified by the letter "P" and which is inclined. It is in Figure 2 where the plane is perpendicular to the plane where the figure is represented, which is why it is shown in the form of a dashed line and where the angle with respect to a plane transverse to the longitudinal direction (X-X') is represented by the Greek letter "a".

[0084] This inclination of the plane (P) to the right makes the lower part, according to the orientation shown, longer and this lower part of the perimeter edge (1.2.1) of the mouth (1.2) is also more prominent. Detail that is clearly shown in figure 2. This specific configuration allows the lower part of the perimeter edge (1.2.1) to rest in an area closer to the urethra and, the entrance to the tubular section (1.3) through the mouth (1.2) to be more visually accessible to see that the urine is entering the main body (1).

[0085] In this same lower position of the tubular section (1.3) is where the channel (1.3.a) is shown and is the one that rests directly on the woman's skin. Its exterior shape is a curved surface to give rise to the grooved shape without edges. On the inside, this channel (1.3.a) is the one that conducts the urine once it has entered through the mouth (1.2) to the container. In this same embodiment, the channel (1.3.a) is extended upwards by two lateral flanks (1.3.b, 1.3.c) that open forming a "V". These lateral flanks (1.3.b, 1.3.c) help to conduct the urine through their interior but they are also support surfaces that keep the labia minora separated with a certain degree of adherence that ensures tightness.

[0086] The two lateral flanks (1.3. b, 1.3. c) close at the top with an arched section (1.3. e) that expands the upper part, also according to the orientation shown in figure 1, without offering edges that could damage the woman's skin.

[0087] According to this embodiment, the channel (1.3.a) extends straight, defining a longitudinal direction (X-X'). While the preferred configuration is straight, this channel (1.3.a) according to other embodiments allows for a slight curvature. In this case, the longitudinal direction is defined by connecting the two ends of the channel (1.3.a).

[0088] In this same figure 1 it can be observed how the right end of the channel (1.3.a), the end opposite to the mouth (1.2), is extended in a curved section (1.3.d) resulting in a greater inclination with respect to the longitudinal direction (X-X') and a separation of the surface with respect to this same reference, the longitudinal direction (X-X').

[0089] The greater inclination makes the urine descend more easily in operating mode and generates an expansion in the area of ​​the container (1.1) which is located in a more lowered position.

[0090] This lower height position in the operating position means that the liquid, the urine, is stored safely once it has entered the container (1.1) in addition to achieving a greater degree of adaptation to the woman's anatomy during sample collection.

[0091] This greater adaptation to the female anatomy also involves establishing a physical barrier between the urine sample and the entrance to the vagina or anus, which could contaminate the sample. Figure 2 shows how the container (1.1) ends in a flat region, the base (1.1.1), which allows stable support on a horizontal surface once the urine sample has been taken. In this specific case, the channel (1.3.a) is oriented vertically, leaving the mouth (1.2) in the highest possible position. Furthermore, the expansion zone (1.1.2) of the container 1.1) increases the support area and generates greater stability.

[0092] According to another embodiment, the lid (2) includes one or more receptacles, for example in the form of recesses or pockets, adapted to receive test elements, for example sections of test strips, preferably for determining whether the urine is infected. These details are not shown in the figures for clarity so as not to overload the lid with lines, which is represented in transparent mode and includes the lines of the mouth (1.2). According to another example, the test elements are adhered to the inner surface of the lid, the surface that, when the lid is closed, comes into direct contact with the stored urine.

Claims

CLAIMS 1. Device for taking urine samples from women, comprising a main body (1) formed by a container (1.1) accessible through a mouth (1.2) and a lid (2) adapted to close the mouth (1.2) of the main body (1), characterized in that: the container (1.1) extends to the mouth (1.2) by means of a tubular section (1.3); the tubular section (1.3) comprises a channel (1.3.a) with a curved section that extends in a longitudinal direction (X-X'), at least in one section, where said channel (1.3.a) is extended on either side by two lateral flanks (1.

3. b, 1.3.c), a right flank (1.3.b) and a left flank (1.3.c), both configured in a "V" shape to rest on the woman's skin between the labia minora; The channel (1.3.a) extends at its end opposite the mouth (1.2) of the main body (1) in a curved section (1.3.d), separating from the longitudinal direction (X- X'), to give rise to an expansion (1.1.2) of the container (1.1). 2.- Device according to claim 1, wherein the mouth (1.2) has a configuration of its perimeter edge (1.2.1) contained in a plane (P) inclined with respect to the plane perpendicular to the longitudinal direction (X-X') and, such that the region of the perimeter edge (1.2.1) close to the channel (1.3.a) is further away from the container (1.1) than the rest of the region of the perimeter edge (1.2.1).

3. Device according to any of the preceding claims, wherein the container (1.1) comprises a flat base (1.1.1), adapted to support the device on the base (1.1.1) in such a way that the longitudinal direction (X-X') has an inclination with respect to the direction perpendicular to the base (1.1.1) in the range [-255, 255], and more preferably in the range [-205, 205], and more preferably in the range [-155, 15°] ;and more preferably in the range [-105, io°], and more preferably in the range [-55, 55], and more preferably the longitudinal direction (X-X') is perpendicular to the base (1.1.1). 4.- Device according to any of the preceding claims, wherein the lateral flanks (1.3.b, 1.3.c) are flat. 5.- Device according to any of the preceding claims, wherein a wall section (1.

3. e) of the tubular section (1.3) connects the lateral flanks (1.

3. b, 1.3.c) at an end opposite to the channel (1.3.a) and is configured to form a curved surface with a curved arc section, the section according to a plane perpendicular to the longitudinal direction (X-X'). 6.- Device according to any of the preceding claims, wherein the material of the main body (1) is elastically deformable. 7.- Device according to any of the preceding claims, wherein the material of the lid (2) is elastically deformable. 8.- Device according to any of claims 6 to 7, wherein the material is silicone. 9.- Device according to any of the preceding claims, wherein the cover (2) is configured to externally embrace the mouth (1.2) of the main body (1) establishing a seal between the mouth (1.2) and the cover (2). 10:- Device according to any of the preceding claims, wherein the perimeter edge (1.2.1) of the mouth (1.2) is thickened to increase resistance to deformation. 11.- Device according to any of the preceding claims, wherein all the edges are rounded. 12.- Device according to any of the preceding claims, wherein the lid (2) comprises one or more receptacles, adapted to house one or more test elements, preferably for determining the existence of infections, where the one or more receptacles are in fluid communication with the interior of the main body (1) when the lid (2) is closing the mouth of the device. 13.- Device according to any of the preceding claims, wherein the cover (2) comprises one or more regions comprising one or more test elements, preferably joined by adhesive. 14.- Device according to claims 12 or 13, wherein the test elements are dry chemistry elements, preferably sections of strips.

15. Device according to the preceding claim, wherein the test elements are adapted to identify at least the presence of: nitrites; leukocytes; hematuria; proteins; - a combination of any of the foregoing. 16.- Device according to any of the preceding claims, wherein the cover (2), the main body (1) or both (1, 2) are transparent to allow visual access.

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