A female urine sample collector

Abstract

The present application relates to a female urine sample collector, which can collect clean urine samples, i.e. urine samples not contaminated by body fluids near the urethra or other contaminants. The collector adopts a specific structural design, which can collect urine samples without damaging the female skin and avoid contamination of urine samples during the collection process. The specific embodiments described below also have other additional advantages.

Description

Technical Field

[0001] This application relates to a female urine sample collector capable of collecting clean urine samples, i.e., urine samples that are not contaminated by bodily fluids or other contaminants near the urethra.

[0002] This sample collector employs a specific structural design that enables the collection of urine samples without damaging the woman's skin and avoids contamination of the urine samples during collection. The specific implementation described below also offers other additional advantages. Background Technology

[0003] Collecting clean urine samples from women for subsequent laboratory testing is a complex procedure that is often invasive and can cause damage, irritation, or both.

[0004] For hospitalized women, urine samples are usually collected using a urinary catheter. Although the surface and tip of the catheter are mostly designed to be relatively blunt and rounded, it will still come into contact with and rub against the narrow urethra during insertion, especially in elderly women with thinner and more fragile skin, who are more susceptible to injury.

[0005] Although a urinary catheter can drain urine, the drained urine still needs to be transferred to a container suitable for transport to the laboratory.

[0006] Another method of urine sample collection involves using a container and having the woman lie down. In this position, the urethra is positioned higher and protected by the labia minora, while the vagina and anus are relatively close to the urethra. Given this, it is necessary to make the urethral area more accessible, as the expelled urine can come into contact with the external areas of the vagina or anus as it flows downwards, thus becoming contaminated.

[0007] The data collector disclosed in this application can effectively overcome the above-mentioned shortcomings. Summary of the Invention

[0008] This application relates to a urine sample collection device for women. The collection device includes: The main body consists of a container with an opening leading to the interior; the lid is adapted to close the opening of the main body.

[0009] The collector consists of two parts: a main body and a cover. The main body has an opening and a container. The opening leads into the interior of the main body, allowing urine to enter the container and thus isolating the urine from any potential contaminants.

[0010] Although the sampler can be positioned and oriented arbitrarily in space, in its operational state, the woman lies supine, for example, in a hospital bed, to ensure the urethra is accessible for urine sample collection. The sampler is positioned appropriately based on the exposure of the anatomical structures near the urethra. In the following text, when the sampler is referred to as being in its operational state, this refers to the aforementioned state.

[0011] In this supine position, the urethra is at its highest point, while the vagina is separated from the urethra and located at a lower position. Urine flowing from this position will descend and may be contaminated first by the vagina, and subsequently even by the anal area, rendering the urine sample unusable. This description follows this order because the relevant anatomical structures are distributed in this sequence when viewed from high to low, thus representing the likely path urine takes under the influence of gravity.

[0012] The labia minora are located on either side of the skin area between the urethra and vagina. When the medical staff responsible for collecting urine samples separate the labia minora, their tendency to close helps to keep the collection device in the proper position. More preferably, the labia minora may even partially or completely adhere to the outer surface of the collection device, thereby creating a leak-proof seal and preventing urine from flowing down the outside of the collection device and entering the container through the mouth.

[0013] In other words, the opening of the collector can completely catch the flowing urine, allowing the urine to enter the collector without contamination.

[0014] In a preferred embodiment of this application, the collector is designed to extend into the perineum from near the urethral outlet, preferably slightly spaced from and not in contact with the urethral outlet, within the vulvar area during use.

[0015] The leak-proof seal formed between the collector and the woman's skin, as well as its protective function against damage to the woman, are attributed to its construction, as detailed below.

[0016] As described above, when collecting samples, the mouth of the sampler is positioned near the urethra. When the woman is lying on her back, it is positioned at the lower part of the urethra according to the direction of gravity.

[0017] In one embodiment, the collector's container extends to the opening via a tubular segment; The tubular segment includes a channel with an arcuate cross-section, the channel extending longitudinally in at least one section XX′, and two flanks extending on both sides of the channel to form a right flank and a left flank, the two flanks being arranged in a V-shape to fit against the skin between the labia minora of a woman; The channel extends at one end opposite the opening of the main body, forming a curved section that deviates from the longitudinal direction XX′, thus forming the expansion section of the container.

[0018] According to the specific construction described above, the container extends to the opening via a tubular segment that guides urine entering through the collector's opening into the container. This tubular segment has a specially designed structure to accommodate the shape of the female urethra, ensuring that the urine remains uncontaminated and does not damage the woman's skin.

[0019] Not damaging the skin means avoiding potential infections and pain, which are two major advantages of this collector.

[0020] The tubular segment includes a channel with an arcuate cross-section. In use, the outer surface of this arcuate channel remains in contact with the woman's skin and is supported in the area between the urethra and vagina during sample collection. The arcuate cross-section prevents the formation of sharp edges that could potentially damage the skin. Simultaneously, the arcuate structure forms a channel on its inner side for guiding urine into the container.

[0021] The channel extends to form two flanks on either side: a right flank and a left flank, arranged in a V-shape. That is, the two flanks converge at the curved channel, resulting in a structure that lacks the apex of a V-shape; instead, the channel is closer to the lower part of a U-shape. These flanks help guide urine inwards while keeping the labia minora separated, preventing contamination from contact with urine. The collector forms a seal between itself and the woman's skin, preventing leakage of urine from the urethra.

[0022] Urine should flow under gravity until it reaches the container, and the container should not only be able to hold the urine but also prevent it from flowing out again.

[0023] Therefore, the channel is curved at the end region opposite the inlet opening and deviates from the longitudinal direction XX′ defined by its preceding section. This deviation is used to form the expansion portion of the container.

[0024] When collecting urine samples, with the channel supported on the skin between the urethra and vagina, the longitudinal direction XX′ defined by the channel is downward. Therefore, urine entering through the collector's opening tends to flow inward and reach the inside of the container. However, any change in tilt can cause urine to leak out of the container, especially as the container gradually fills. To address this issue, the collector is equipped with an expansion section, forming the final curved section of the channel that deviates from the longitudinal direction XX′.

[0025] Based on the aforementioned definitions of position and direction, the final curved section deviates from the longitudinal direction XX′ due to its curvature, thus forming a section with increased inclination, placing the expansion portion of the container at a lower position. In other words, in use, this structure allows the expansion area of ​​the container to fit snugly against the woman's vagina, even extending beyond the skin area where the vagina is located. In this state, the expansion portion is positioned lower, ensuring that urine does not leak out again.

[0026] Furthermore, in one embodiment, the V-shape formed by the two flanks extends into the expansion area, helping to maintain accessibility to the area and protect the collected urine from contamination.

[0027] In one embodiment of the collector described above, the opening has a circumferential lip that lies in a plane that is inclined relative to a plane perpendicular to the longitudinal direction XX′, such that the area of ​​the circumferential lip near the channel is further away from the container than the rest of the area.

[0028] In this embodiment, the circumferential lip edge of the mouth is inclined, meaning it is not lateral to the longitudinal direction (XX′). This inclined structure ensures that the opening of the mouth faces the medical personnel responsible for collecting samples, allowing for visual observation of the opening and enabling them to determine whether the sample collector is properly positioned.

[0029] Due to this inclined setting, the portion of the circumferential lip corresponding to the channel extends further and is supported near the urethra, so that the circumferential lip forms a seal at the position adjacent to the urethra, thereby preventing urine from leaking out of the collector.

[0030] In one embodiment of the collector applicable to any of the above embodiments, the container includes a flat bottom adapted to support the collector such that the tilt angle of the longitudinal direction XX′ relative to the direction perpendicular to the bottom is in the range of [-25°, 25°], more preferably in the range of [-20°, 20°], more preferably in the range of [-15°, 15°], more preferably in the range of [-10°, 10°], more preferably in the range of [-5°, 5°], and, more preferably, the longitudinal direction XX′ is perpendicular to the bottom.

[0031] After urine sample collection is completed using the collector, the cover forms a seal, allowing the collector to be transported. The flat bottom improves the stability of the collector when used as a support surface. When using this bottom as a support surface for the collector on a horizontal surface, the channel is preferably vertical, with both the horizontal and vertical directions referenced to the direction of gravity. However, according to different embodiments of this application, the channel may also have a certain inclination. The ranges indicated by square brackets “[ ]” above have the usual mathematical meaning, that is, both endpoints of the range are included, forming a closed interval; in contrast, when indicated by parentheses “()”, the endpoints do not belong to the interval, forming an open interval.

[0032] The above structure achieves high stability because the expansion section increases the support area and keeps the opening as far away from the bottom as possible, thereby preventing collected urine from approaching the closed area between the cover and the body when the collector closes.

[0033] In one embodiment of the data collector applicable to any of the above embodiments, the side wings are planar.

[0034] According to this design, the two side wings form two inclined planes that converge at the lower part of the channel. This allows the labia minora to remain open and separated from each other during urine sample collection. The tendency of the labia minora to close helps improve fit and creates a seal sufficient to prevent urine from leaking out of the collector.

[0035] In one embodiment of the collector applicable to any of the above embodiments, the wall segment of the tubular section connects the two side wings to one end opposite the channel and is configured to form a curved surface, the curved surface having an arc-shaped cross-section in a plane perpendicular to the longitudinal direction XX′.

[0036] According to this embodiment, the two side wings opposite to the arc-shaped channel are connected by a wall segment, thereby sealing the tubular segment. This forms a tubular segment with a large cross-section, which facilitates the entry of urine while avoiding the formation of sharp corners, thus creating a smooth outer surface and preventing damage to the woman's skin.

[0037] In one embodiment of the collector applicable to any of the above embodiments, the body is made of a deformable elastic material.

[0038] Using deformable elastic materials achieves several important technical advantages. First, given the differences in anatomical structure among women, the design of the sampling device optimizes its close contact with the skin, ensuring a tight seal. Simultaneously, the material's deformability helps achieve maximum fit. Furthermore, because the material can elastically deform, the sampling device can return to its pre-designed shape after sampling, thus maintaining the aforementioned advantages.

[0039] Another technological advantage is that the material can deform when the collector comes into contact with the skin, thereby reducing local stress and preventing damage.

[0040] In one embodiment of the collector applicable to any of the above embodiments, the cover is made of a deformable elastic material.

[0041] The cover is also made of a deformable elastic material, which helps ensure a tight seal between the cover and the body. When both are elastically deformable, if one deforms, the other deforms accordingly, thereby improving the seal between them.

[0042] In one embodiment of the collector applicable to either of the two embodiments described above, the deformable elastic material is silicone.

[0043] Silicone allows for significant elastic deformation. Its high strength prevents breakage during handling. Furthermore, as an inert material, it has a very low likelihood of causing allergies.

[0044] In one embodiment of the collector applicable to any of the above embodiments, the cover is configured to surround the opening of the body from the outside to form a seal between the opening and the cover.

[0045] The circumferential lip of the main body is adapted to conform to the skin and form a seal, and it is primarily this circumferential lip that gives it the most suitable shape. It has been verified that the closure method of the cap surrounding the opening of the main body from the outside can establish a suitable leak-proof seal.

[0046] In one embodiment of the collector applicable to any of the above embodiments, the circumferential lip of the mouth is thickened to improve its resistance to deformation.

[0047] The thickened circumferential lip improves resistance to deformation without requiring changes to the material. This enhanced resistance to deformation allows for a slightly improved fit when adhering to skin near the urethra, as the circumferential lip is the contact area and needs to create a good seal to prevent urine leakage from the container.

[0048] Furthermore, higher resistance to deformation also facilitates a more reliable sealing fit with the cover, as possible deformation can cause the surfaces in contact between the cover and the collector opening to separate.

[0049] In one embodiment of the data collector applicable to any of the above embodiments, all corners are rounded.

[0050] This design ensures that when collecting urine samples, even if the sampler comes into contact with the woman's skin using a surface not specifically designed for skin contact, no damage will occur. Therefore, accidental injury can be avoided even if the sampler is in different orientations.

[0051] In one embodiment of the collector applicable to any of the above embodiments, the cover includes one or more receptacles adapted to accommodate one or more detection elements, preferably used to determine the presence of infection. When the cover closes the opening of the collector, the one or more receptacles are in communication with the interior of the main body.

[0052] Detection elements can take many forms, but are primarily found in the form of test strips. When the detection element comes into contact with a sample, such as urine, it reacts and produces a change in appearance depending on its intended use. These reactive test strips include, but are not limited to, strips used to determine the presence of a particular type of infection or chemical property (such as pH). Appearance changes can be, for example, color changes.

[0053] Before the collector is closed with a cover, one or more detection elements are housed in the receiving portion, so that after the opening of the collector is closed with a cover, the detection elements are exposed and come into contact with urine.

[0054] In this way, the presence of infection in the urine can be quickly determined before it is sent to the laboratory for analysis, or a measurement result from the urine sample can be obtained. The specific measurement depends on the type of detection element located in the container.

[0055] In one embodiment of the collector applicable to any of the above embodiments, the cover includes one or more regions provided with one or more detection elements, which are preferably attached by an adhesive.

[0056] In the foregoing embodiments, the cover is provided with one or more receiving portions. In another embodiment compatible with the foregoing embodiments, the detection element is directly attached to the cover without changing the structure of the cover; only a region for setting the detection element needs to be reserved on the cover. Preferably, a portion of the inner area of ​​the cover can be used as the area for setting the detection element, and this area can come into contact with urine when the cover closes the opening of the collector.

[0057] Preferably, the detection element is disposed within the area of ​​the cover by an adhesive.

[0058] In one embodiment applicable to any of the above-described collectors including a detection element, the detection element is a dry chemical detection element, preferably a strip of test paper.

[0059] Dry chemical test strips are typically used for rapid testing in open containers. In this embodiment, the dry chemical detection element is attached to the cover, allowing the collector to perform only urine collection without additional operations, and providing preliminary test results from one or more detection elements once the cover is closed.

[0060] In one embodiment of a collector including a detection element suitable for any of the above-described types, the detection element is adapted to detect the presence of at least one of the following substances: Nitrite; leukocyte; hematuria; protein; Any combination of the above.

[0061] Although more detection elements could be added, the above options are believed to provide some of the most relevant test results for women’s health in advance.

[0062] In one embodiment of the collector applicable to any of the above embodiments, the cover and / or body are transparent so that changes in the appearance of the test strip can be observed.

[0063] When the detection element comes into contact with and reacts with a urine sample, a visible change occurs. If one or both of the body and the cap are transparent, this visual change can be observed without opening the cap. Opening the cap before analysis may allow contaminants to enter, leading to distorted laboratory test results or even invalidating the test. Attached Figure Description

[0064] The present application will now be described in further detail with reference to the accompanying drawings and preferred embodiments. The above and other features and advantages of the present application will become clearer from the following description. It should be understood that the preferred embodiments are given as illustrative examples only and do not constitute a limitation of the present invention.

[0065] Figure 1 This is a three-dimensional structural diagram of the collector provided in a preferred embodiment of this application in one state. The figure shows the main body and the cover, wherein the cover is shown with transparent lines so that the circumferential lip of the collector's opening can be observed simultaneously.

[0066] Figure 2 This is a side view of the collector provided in one preferred embodiment of this application. The collector is supported on a horizontal surface with its bottom, for example, in a state after sample collection is completed.

[0067] Figure 3 This is a three-dimensional structural diagram of the collector provided in one preferred embodiment of this application in another state. The interior of the main body can be observed from the direction shown in the diagram. Detailed Implementation

[0068] This application relates to a urine sample collection device for women, a preferred embodiment of which is, for example... Figures 1 to 3 As shown.

[0069] The collector in this preferred embodiment is made of a deformable elastic material and has the shape shown in the attached drawings.

[0070] Figure 1 The main body 1 and the cover 2 are shown, with the cover 2 shown in transparent lines. That is, in addition to the cover 2, the circumferential lip 1.2.1 of the opening 1.2 leading into the interior of the main body 1 is also shown.

[0071] Figure 1 The orientation of the main body 1 shown is basically consistent with the orientation of the main body 1 when the sample was collected.

[0072] according to Figure 1 As shown, the circumferential lip 1.2.1 of the opening 1.2 of the main body 1 is located on the left side, and the opening 1.2 leads into the interior of the main body 1. A relatively large area is visible on the right side of the main body 1; this area is referred to as container 1.1. This area is called container 1.1 because it is used to hold the collected urine sample.

[0073] A tubular segment 13 extends between the mouth 1.2 and the container 1.1, which forms the neck of the container 1.1.

[0074] Following the diagram from left to right component, it can be seen that the circumferential lip 1.2.1 of the mouth 1.2 is thickened and teardrop-shaped. Specifically, its lower part is V-shaped with a rounded tip to avoid forming an edge; straight segments extend upwards from this lower part, and these straight segments are ultimately connected to each other by arc-shaped segments. The above structure... Figure 3 The diagram shows this more clearly.

[0075] See you again Figure 1 As can be seen in its illustrated orientation, the entire circumferential lip 1.2.1 of the mouth 1.2 lies within the inclined plane indicated by the letter "P". Figure 2 In the middle, since plane P is perpendicular to Figure 2 The plane in the diagram is represented by a dashed line, and the angle between plane P and the plane that is transverse to the longitudinal direction XX′ is represented by the Greek letter "α".

[0076] As shown in the diagram, the rightward tilt of plane P results in a greater extension and more prominent lower portion of the circumferential lip 1.2.1 of the mouth portion 1.2. This detail is... Figure 2This is shown more clearly in the diagram. The specific construction described above allows the lower part of the circumferential lip 1.2.1 to be supported in a region closer to the urethra, while making the entrance from the orifice 1.2 to the tubular segment 1.3 easier to observe, thus enabling direct observation of the urine entering the body 1.

[0077] Channel 1.3.a is also located at the lower part of tubular segment 1.3 and can directly contact the woman's skin. The outer surface of channel 1.3.a is curved, thus forming a groove-like structure without sharp edges. After urine enters through the opening 1.2, it is guided by channel 1.3.a to flow into the container along the inner side of channel 1.3.a.

[0078] In the same embodiment, channel 1.3.a extends upward to form two side wings 1.3.b and 1.3.c, which open and form a V-shape. Side wings 1.3.b and 1.3.c not only help guide urine flow along their inner sides but also form a support surface, keeping the labia minora separated while maintaining a certain degree of contact with the labia minora to ensure a seal.

[0079] according to Figure 1 As shown in the diagram, the upper parts of the two side wings 1.3.b and 1.3.c are closed by the arc-shaped segment 1.3.e, which widens the upper part and does not form an edge that could damage the woman's skin.

[0080] According to this embodiment, channel 1.3.a extends in a straight line, thereby defining the longitudinal direction XX′. Although channel 1.3.a extends in a straight line in the preferred embodiment, in other embodiments, channel 1.3.a may also have a slight curvature. In this case, the longitudinal direction XX′ is defined by a straight line connecting the two ends of channel 1.3.a.

[0081] Depend on Figure 1 It can also be seen that the right end of channel 1.3.a, that is, the end opposite to the opening 1.2, extends to form a curved section 1.3.d. The degree of inclination of this curved section 1.3.d relative to the longitudinal direction XX′ increases, causing its surface to deviate relative to the longitudinal direction XX′, which serves as a reference.

[0082] The increased tilt makes it easier for urine to flow downwards when in use, and causes the lower part of the container 1.1 to form an expansion 1.1.2.

[0083] In use, this lower position allows the liquid, i.e., urine, to be safely stored after entering container 1.1, while also improving the compatibility of the sampler with female anatomy during sample collection.

[0084] This improved adaptation to female anatomy can also create a physical barrier between the urine sample and the vaginal opening or anus, thereby reducing the possibility of urine sample contamination.

[0085] Figure 2 The container 1.1 has a flat area at its end, namely the bottom 1.1.1, which provides stable support on a horizontal surface after urine sample collection. In this specific case, the channel 1.3.a is arranged vertically, positioning the opening 1.2 as high as possible. Furthermore, the expansion portion 1.1.2 of the container 1.1 increases the support area, thereby achieving greater stability.

[0086] According to another embodiment, the cap 2 includes one or more receiving portions, such as in the form of a groove or cavity, thereby forming a pocket for accommodating a detection element, such as a test strip segment, preferably for determining the presence of infection in the urine. For clarity, these details are not shown in the drawings to avoid drawing too many lines on the cap 2—the cap 2 is shown with transparent lines, and lines for the opening 1.2 are also shown. According to another embodiment, the detection element is adhered to the inner surface of the cap 2, which is in direct contact with the stored urine when the cap 2 is closed.

Claims

1. A urine sample collection device for women, comprising: The main body (1) comprises a container (1.1) having an opening (1.2) leading to the interior; and a lid (2) adapted to close the opening (1.2) of the main body (1), characterized in that: The container (1.1) extends to the opening (1.2) via a tubular segment (1.3). The tubular segment (1.3) includes a channel (1.3.a) with an arcuate cross-section, the channel (1.3.a) extending longitudinally (XX′) at least in one section, and two flanks (1.3.b, 1.3.c) extending from both sides of the channel (1.3.a), namely the right flank (1.3.b) and the left flank (1.3.c), respectively, the two flanks (1.3.b, 1.3.c) being arranged in a V-shape to abut against the skin between the labia minora of a woman; The channel (1.3.a) extends at one end opposite to the opening (1.2) of the body (1) and forms a curved section (1.3.d) that deviates from the longitudinal direction (XX′) to form an expansion (1.1.2) of the container (1.1).

2. The female urine sample collector according to claim 1, characterized in that, The opening (1.2) has a circumferential lip (1.2.1) located in a plane (P) that is inclined relative to a plane perpendicular to the longitudinal direction (XX′), such that the area of ​​the circumferential lip (1.2.1) near the channel (1.3.a) is further away from the container (1.1) than the rest of the area.

3. The female urine sample collection device according to any one of the preceding claims, characterized in that, The container (1.1) includes a flat bottom (1.1.1) adapted to support the collector such that the angle of inclination of the longitudinal direction (XX′) relative to the direction perpendicular to the bottom (1.1.1) is in the range of [-25°, 25°], more preferably in the range of [-20°, 20°], more preferably in the range of [-15°, 15°], more preferably in the range of [-10°, 10°], more preferably in the range of [-5°, 5°], and more preferably, the longitudinal direction (XX′) is perpendicular to the bottom (1.1.1).

4. The female urine sample collection device according to any one of the preceding claims, characterized in that, The flanks (1.3.b, 1.3.c) are all planar.

5. The female urine sample collection device according to any one of the preceding claims, characterized in that, The wall segment (1.3.e) of the tubular segment (1.3) connects the two side wings (1.3.b, 1.3.c) to one end opposite to the channel (1.3.a) and is configured to form a curved surface, the curved surface having an arc-shaped cross section in a plane perpendicular to the longitudinal direction (XX′).

6. The female urine sample collection device according to any one of the preceding claims, characterized in that, The main body (1) is made of a deformable elastic material.

7. The female urine sample collection device according to any one of the preceding claims, characterized in that, The cover (2) is made of a deformable elastic material.

8. The female urine sample collector according to claim 6 or 7, characterized in that, The deformable elastic material is silicone.

9. The female urine sample collection device according to any one of the preceding claims, characterized in that, The cover (2) is configured to surround the opening (1.2) of the body (1) from the outside to form a seal between the opening (1.2) and the cover (2).

10. The female urine sample collection device according to any one of the preceding claims, characterized in that, The circumferential lip (1.2.1) of the mouth (1.2) is thickened to improve its resistance to deformation.

11. The female urine sample collection device according to any one of the preceding claims, characterized in that, All corners are rounded.

12. The female urine sample collection device according to any one of the preceding claims, characterized in that, The cover (2) includes one or more receiving portions adapted to accommodate one or more detection elements, which are preferably used to determine whether an infection exists; when the cover (2) closes the opening (1.2), the one or more receiving portions are in communication with the interior of the body (1).

13. The female urine sample collection device according to any one of the preceding claims, characterized in that, The cover (2) includes one or more areas provided with one or more detection elements, which are preferably attached by an adhesive.

14. The female urine sample collector according to claim 12 or 13, characterized in that, The detection element is a dry chemical detection element, preferably a test strip segment.

15. The female urine sample collector according to claim 14, characterized in that, The detection element is adapted to detect the presence of at least one of the following: Nitrite; leukocyte; hematuria; protein; Any combination of the above.

16. The female urine sample collection device according to any one of the preceding claims, characterized in that, The cover (2) and / or the main body (1) are transparent so that they can be visually observed.

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