Urine sample collector

Abstract

A system and method can collect and store urine without invasive medical procedures while maintaining its sterile condition for medical examinations. The system includes an absorbent member for collecting urine. The system may further include an extraction system. The system can also comprise a tester. For example, the tester may include an indicator (e.g., a test strip and / or a rapid diagnostic test) and / or a sensor, and / or an automated tester.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480030990.5 (22) Application Date 2024.05.06 (30) Priority Data 63 / 464,634 2023.05.08 US (85) PCT International Application Entering National Phase Date 2025.11.07 (86) PCT International Application Application Data PCT / IL2024 / 050428 2024.05.06 (87) PCT International Application Publication Data WO2024 / 231916 EN 2024.11.14 (71) Applicant Itan Azaria Address Israel (72) Inventor Itan Azaria (74) Patent Agency Shanghai Yisheng Patent & Trademark Agency (General Partnership) 31218 Patent Attorney Zhai Yu (51) Int.Cl. A61F 5 / 451 (2006.01) A61B 10 / 00 (2006.01) (54) Invention Title: Urine Sample Collector (57) Abstract: A system and method for collecting and storing urine without invasive medical procedures while maintaining its sterility for medical examination. The system includes an absorbent component for collecting urine. The system may further include an extraction system. The system may also include a testing instrument. For example, the testing instrument may include indicators (e.g., test strips and / or rapid diagnostic tests) and / or sensors, and / or automated testing instruments. Claims: 2 pages Description: 24 pages Drawings: 28 pages CN 121079058 A 2025.12.05 CN 1 21 07 90 58 A 1. A urine collection system, characterized in that it comprises: a sponge; and a housing configured to accommodate the sponge. 2. The system of claim 1, further comprising chemical and / or biological testing. 3. The system of claim 1, further comprising a sensor configured to alert the user at the start of urination. 4. The system of claim 1, further comprising a sensor configured to alert the user when the sponge has absorbed the required amount of urine. 5. The system of claim 4, wherein the alert includes an audible alert, a visual alert, or both. 6. The system of claim 1, wherein the housing includes an opening for facilitating the entry of urine. 7. The system of claim 1, wherein the housing includes an opening for draining overflowing urine. 8. The system of claim 1, further comprising a frame for securing the housing in place.9. The system of claim 1, wherein the sponge is a melamine sponge. 10. A method for collecting urine, comprising: placing a urine collector comprising a shell and a sponge on a subject; attaching the shell to the subject and positioning the sponge above the subject's urethral opening; and absorbing urine excreted by the subject with the sponge. 11. The method of claim 10, further comprising inserting the sponge into the shell. 12. The method of claim 11, further comprising unfolding the plastic shell before insertion. 13. The method of claim 10, further comprising collecting urine from the sponge into a testing instrument. 14. The method of claim 13, wherein the testing instrument is a biological testing instrument. 15. The method of claim 13, wherein the testing instrument is integrated with the collector. 16. The method of claim 13, wherein the testing instrument is located outside the collector. 17. The method of claim 13, wherein the testing instrument is a chemical testing instrument. 18. The method of claim 10, further comprising securing the shell in place using a standard diaper. 19. A system for collecting urine samples from a subject, characterized in that it comprises: a shell configured to be attached to a user; an absorbent material configured to absorb a sample, which is at least partially surrounded by the shell; and an opening in the shell to expose the absorbent material for absorbing the subject's urine. 20. The system of claim 19, characterized in that the absorbent material comprises a sponge. 21. The system of claim 19, characterized in that it further comprises a core in contact with the absorbent material, the core configured to draw urine from the absorbent material to an indicator. 22. The system of claim 21, characterized in that the indicator is configured to indicate the chemical properties of the urine. 23. The system of claim 21, characterized in that the core is at least partially enclosed by a tube. Claims 1 / 2 page 2 CN 121079058 A 24. The system of claim 21, characterized in that the core comprises a volume indicator configured to indicate when the absorbent material has collected sufficient urine for analysis. 25. The system of claim 19, further comprising: a covering layer located between the patient and the absorbent material. 26. The system of claim 25, wherein the covering layer is configured to prevent a first flow of urine from reaching the absorbent material. 27. The system of claim 26, wherein the covering layer is flushed away by the first flow of urine.28. The system of claim 26, wherein the covering layer absorbs the first stream of urine. 29. The system of claim 19, wherein the outer shell is flexible. 30. The system of claim 19, wherein the outer shell is provided with an adhesive at the opening edge. 31. The system of claim 30, wherein the opening edge includes an adhesive-free region configured to facilitate the outflow of excess urine from the absorbent material. 32. The system of claim 19, further comprising an absorbent material cap covering the opening. 33. The system of claim 32, wherein the absorbent material cap is hydrophilic. 34. The system of claim 32, wherein the absorbent material cap is hydrophobic and impermeable to water. 35. The system of claim 32, wherein the absorbent material cap is hydrophobic and permeable to water. 36. The system of claim 24, wherein the analysis is a chemical analysis. 37. The system of claim 24, wherein the analysis is a chemical-biological test. 38. The system of claim 19, further comprising a diaper for wrapping the system. 39. The system of claim 21, wherein the indicator is selected from the group consisting of ninhydrin, fluorescein isothiocyanate (FITC), azo dyes, color-changing inks, universal pH indicators, or combinations thereof. 40. A system for extracting urine from a sampler, comprising: a sampler holder configured to support the sampler; and an extractor configured to release urine from the sampler. 41. The system of claim 40, wherein the sampler holder includes a receiving portion that mates with the sampler. 42. The system of claim 40, wherein the extractor includes a push rod configured to compress the sampler when it is held in the sampler holder. 43. The system of claim 40, further comprising: a testing instrument for determining the properties of the urine. 44. The system of claim 43, wherein the testing instrument includes a sensor for reading the indicator. 45. The system of claim 44, wherein the tester includes a processor for interpreting the sensor output. 46. The system of claim 43, wherein the tester includes an indicator. 47. The system of claim 44, wherein the sensor is configured to read the indicator on the sampler. 48. The system of claim 43, wherein the tester is modular. Claims 2 / 2 Page 3 CN 121079058 A Urine Sample Collector

[0001] Related Applications This application claims priority to U.S. Application No. 63 / 464,634, filed May 8, 2023, with the U.S. Patent and Trademark Office.

[0002] Technical Field and Background Art In some embodiments, the present invention relates to a system and method for collecting and storing urine without invasive medical procedures, and more specifically (but not limited thereto), the system and method are capable of maintaining the sterility and integrity of urine for medical testing.

[0003] Urine testing is a common medical test performed in the general population, including chemical tests and urine culture tests. However, there are individuals who cannot urinate independently, particularly newborns from birth to the age at which they can urinate independently (usually around two years old), hospitalized patients, and the elderly. Similarly, in veterinary applications, collecting uncontaminated urine samples from animals can be challenging. This problem is further complicated when performing urine culture tests. Normal urine is usually a sterile liquid, but in some cases, even in healthy individuals, urine culture samples may show bacterial growth. Because the urethra is not sterile and is located near the male and female reproductive organs and anus, bacteria from the genital area or skin surface may enter the urine sample during urination.

[0004] Existing solutions include disposable urine bags for collecting infant urine, one type of sterile bag having an adhesive layer at the opening that fits around the infant's genitals and collects urine in the bag when the infant urinates. For dogs, owners can follow their pets with a bowl and try to collect urine as they urinate. However, existing solutions are not always effective because it is difficult to keep the sample sterile, sterile bags often leak, and urine is difficult to transfer to test tubes. These problems mainly and mostly occur in women, and this solution is often less than ideal due to the limitations of female anatomy.

[0005] Another existing solution is catheterization, which involves inserting a thin tube aseptically into the urethra to collect urine directly from the bladder. This method is generally able to collect urine aseptically and is used for urine collection from uncooperative patients, such as infants. While this method preserves the integrity of the urine sample, it is a painful and invasive procedure, requiring catheter insertion only by qualified medical personnel, resulting in long waiting times. Non-sterile catheterization can lead to complications such as introducing infection into the urinary tract.

[0006] Another existing solution is suprapubic bladder puncture, which involves percutaneously puncturing the bladder to sterilely collect urine into a syringe. This method is the most effective way to obtain a true urine sample, with a level of pain comparable to routine blood draws, and can be used in infants, children, and animals. It is safer than catheterization in terms of the risk of urinary tract infection. However, the bladder must be relatively full for positioning.

[0007] US Patent No. 11,426,303 appears to disclose a device for collecting urine excreted from a user's body, the device comprising a fluid collection assembly having at least one layer for guiding urine into an inner lumen, an outer cover covering a portion of said at least one layer, and at least one opening for receiving urine, wherein said opening is a portion of the fluid collection assembly not covered by the outer cover. The device further includes a cap closing a first end of the assembly, a tube having a first end in fluid communication with the cap, and a shape-retaining element configured to flex the assembly into a curved shape and retain that shape until it is adjusted. The assembly is configured to conform to the user's body, and at least one opening functionally engages with the user's urethral opening.

[0008] Further references describing the urine collection method are U.S. Patent No. 11,446,011, Chinese Patent No. 121079058 A 111297545B, Chinese Patent No. 213310939U, Chinese Patent No. 110934689B, U.S. Publication No. 2007 / 00185466, Chinese Patent Application No. 109171822A, Chinese Patent Application No. 2936204Y, Russian Patent No. 2505274, and U.S. Patent No. 11,395,871.

[0009] Therefore, there is a need to provide a system and method for collecting and storing urine while maintaining its sterility for use in medical examinations (e.g., chemical detection and urine culture) without the need for invasive medical procedures. Summary of the Invention

[0010] According to one aspect of some embodiments of the present invention, a urine collection system is provided, comprising: a sponge; and a housing for receiving said sponge.

[0011] According to some embodiments of the present invention, the system further includes chemical and / or biological testing.

[0012] According to some embodiments of the present invention, the system further includes a sensor for alerting the user when urination begins.

[0013] According to some embodiments of the present invention, the system further includes a sensor for alerting the user when the sponge has absorbed the required amount of urine.

[0014] According to some embodiments of the present invention, the alert includes an audible alert, a visual alert, or both.

[0015] According to some embodiments of the present invention, the housing includes an opening for facilitating urine entry.

[0016] According to some embodiments of the present invention, the housing includes an opening for draining overflowing urine.

[0017] According to some embodiments of the present invention, the system further includes a frame for securing the housing in place.

[0018] According to some embodiments of the present invention, the sponge is a melamine sponge.

[0019] According to one aspect of some embodiments of the present invention, a urine collection method is provided, the method comprising:A urine collector comprising a shell and a sponge is placed on a subject; the shell is adhered to the subject, and the sponge is placed above the subject's urethral opening; the sponge absorbs the urine excreted by the subject.

[0020] According to some embodiments of the invention, the method further includes inserting the sponge into the shell.

[0021] According to some embodiments of the invention, the method further includes unfolding the plastic shell before insertion.

[0022] According to some embodiments of the invention, the method further includes collecting urine from the sponge into a testing instrument.

[0023] According to some embodiments of the invention, the testing instrument is a biological testing instrument.

[0024] According to some embodiments of the invention, the testing instrument is integrated with the collector.

[0025] According to some embodiments of the invention, the testing instrument is located outside the collector.

[0026] According to some embodiments of the invention, the testing instrument is a chemical testing instrument.

[0027] According to some embodiments of the invention, the method further includes securing the shell in place using a standard diaper.

[0028] According to one aspect of some embodiments of the present invention, a system for collecting urine samples from a subject is provided, the system comprising: a housing for attaching to a user; an absorbent material for absorbing the sample, the absorbent material being at least partially surrounded by the housing; and an opening for exposing the absorbent material in the housing to the subject's urine.

[0029] According to some embodiments of the present invention, the absorbent material comprises a sponge.

[0030] According to some embodiments of the present invention, the system further comprises a core in contact with the absorbent material for drawing urine from the absorbent material to an indicator.

[0031] According to some embodiments of the present invention, the indicator is used to indicate the chemical properties of the urine.

[0032] According to some embodiments of the present invention, the core is at least partially enclosed by a tube.

[0033] According to some embodiments of the present invention, the tube comprises a volume indicator for indicating when sufficient urine has been collected for analysis.

[0034] According to some embodiments of the present invention, the system further comprises a covering layer located between the patient and the absorbent material.

[0035] According to some embodiments of the present invention, the covering layer is used to prevent the first stream of urine from flowing onto the absorbent material.

[0036] According to some embodiments of the present invention, the covering layer is washed away by the first stream of urine.

[0037] According to some embodiments of the present invention, the covering layer absorbs the first stream of urine.

[0038] According to some embodiments of the present invention, the outer shell is flexible.

[0039] According to some embodiments of the present invention, the outer shell contains an adhesive at the opening edge.

[0040] According to some embodiments of the invention, the opening edge includes an adhesive-free region configured to facilitate the outflow of excess urine from the absorbent material.

[0041] According to some embodiments of the invention, the system further includes an absorbent material cover over the opening.

[0042] According to some embodiments of the invention, the absorbent material cover is hydrophilic.

[0043] According to some embodiments of the invention, the absorbent material cover is hydrophobic and impermeable.

[0044] According to some embodiments of the invention, the absorbent material cover is hydrophobic and permeable.

[0045] According to some embodiments of the invention, the analysis is a chemical analysis.

[0046] According to some embodiments of the invention, the analysis is a chemical biological test.

[0047] According to some embodiments of the invention, the system further includes a diaper configured to wrap the system.

[0048] According to some embodiments of the invention, the indicator is selected from: ninhydrin, fluorescein isothiocyanate (FITC), azo dyes, color-changing inks, universal pH indicators, or combinations thereof.

[0049] According to some embodiments of the present invention, a system for extracting urine from a sampler is provided, the system comprising: a sampler holder for receiving the sampler; and an extractor for releasing urine from the sampler.

[0050] According to some embodiments of the present invention, the sampler holder includes a receiving portion cooperating with the sampler.

[0051] According to some embodiments of the present invention, the extractor includes a push rod for squeezing the sampler when the sampler is held in the sampler holder.

[0052] According to some embodiments of the present invention, the system further includes: a tester for determining the properties of urine.

[0053] According to some embodiments of the present invention, the tester includes a sensor for reading an indicator.

[0054] According to some embodiments of the present invention, the tester includes a processor for interpreting the output of the sensor.

[0055] According to some embodiments of the present invention, the tester includes an indicator.

[0056] According to some embodiments of the present invention, the sensor is configured to read an indicator on the sampler.

[0057] According to some embodiments of the present invention, the tester is modular.

[0058] Brief Description of the Drawings Some embodiments of the present invention are described herein by way of example in conjunction with the accompanying drawings. The following detailed description is based on the drawings. It should be emphasized that the details shown are merely examples and are used for illustrative discussion of the embodiments of the present invention. Based on this, the description in conjunction with the drawings enables those skilled in the art to clearly understand how to implement the various embodiments of the present invention.

[0059] In the drawings: FIG1 is a schematic diagram of a system for collecting and storing urine according to some embodiments; FIG2A is a schematic diagram of a system for collecting and storing urine according to some embodiments; Specification 3 / 24 pages 6 CN 121079058Figure 2B is a schematic diagram of a system for collecting and storing pet urine according to some embodiments; Figures 3A-3H are schematic diagrams of a system for collecting and storing urine according to some embodiments; Figures 4A-4B are three-dimensional views of a system for collecting and storing urine according to some embodiments; Figures 5A-5B are three-dimensional views of a system for collecting and storing urine according to some embodiments; Figures 6A-6G are schematic diagrams of methods for collecting, storing, and extracting urine according to some embodiments; Figure 7 is a block diagram illustrating a system for collecting and storing urine according to some embodiments of the present invention; Figure 8 is a flowchart illustrating a method for collecting and storing urine according to some embodiments of the present invention; Figure 9 is a flowchart illustrating a method for collecting and detecting urine according to some embodiments of the present invention; Figure 10 is a block diagram illustrating a system for collecting and detecting urine according to some embodiments of the present invention; Figure 11 is a flowchart illustrating a method for collecting and detecting urine according to some embodiments of the present invention; Figure 12 is a block diagram illustrating a system for collecting urine according to some embodiments of the present invention; Figure 13 is a schematic diagram of a urine collection pad according to some embodiments; Figure 14 is a schematic diagram of various covering layers of a sponge according to some embodiments. Figures 15A-15B are schematic top and side views of an indicator device and collection pad assembly according to some embodiments; Figures 16A-16H are schematic diagrams of a core and tube sponge system according to some embodiments; Figures 17A-17E are perspective views of a simplified version of a urine extraction system according to an embodiment of the present invention; Figure 18 is a schematic diagram of a urine extraction system according to some embodiments of the present invention; Figures 19A-19C are schematic diagrams of a urine extraction system 1900 according to some embodiments of the present invention; Figure 20 is a block diagram of a urine extraction system according to some embodiments of the present invention; Figure 21 is a flowchart of a urine detection method according to an embodiment of the present invention; Figure 22 is an image of a core before and after wetting according to some embodiments; Figures 23A-23C are images of a core and tube sponge system according to some embodiments; Figure 24A is a bacterial colony diagram on a melamine sponge according to some embodiments; Figure 24B is a bacterial colony diagram on a polyethylene acrylate sponge according to some embodiments; Figure 25 shows graphs and tables of colony-forming unit (CFU) counts at different time points in the melamine sponge group and the standard petri dish group, based on results obtained from some embodiments. Detailed Description

[0060] In some embodiments of the present invention, therein relates to a system and method for collecting and storing urine without invasive medical procedures, and more specifically, but not limited thereto, the system and method can maintain the sterility of urine when used for medical examinations.

[0061] Overview Some embodiments relate to a system and method for collecting and storing urine without invasive medical procedures.Optionally, the system and method can maintain the sterility of urine for medical examination. Optionally, the system can be adapted to the structure of the body. Optionally, the system can be adapted to the structure of a female body, a human body, and / or an animal body. Optionally, the system can adhere to the genital area. Optionally, the system can adhere to the female genital area. Optionally, the system can store urine in a more comfortable manner. Optionally, the system can store urine in a sterile manner. Optionally, the system does not require invasive procedures. Optionally, the system facilitates the extraction of urine for laboratory testing (e.g., chemical testing, biological testing (e.g., culture testing), etc.).

[0062] According to some embodiments, the system can be applied to newborns (girls and boys) up to the toilet training stage (typically about one and a half years old), hospitalized patients, and disabled adults (men and women) and / or animals. Optionally, the system can be conveniently applied by non-professionals, patients, parents, family members, or caregivers. Optionally, the system may include a device for absorbing urine. Optionally, the device may be anatomically adapted to the female urethra. Optionally, the device may have different sizes and / or anatomical shapes depending on the patient's age and / or body structure.

[0063] In some embodiments, the device may maintain the sterility of urine, for example, when used by a girl. In some cases, the device may be designed to be placed beneath an animal urinating. For example, the housing may be disposed on the ground in a dog's urination path and / or in a litter box in a cat's urination path. The device may absorb urine that falls on it quickly, cleanly, and / or sterilely.

[0064] According to some embodiments, the system may include a disposable part and a reusable part. Optionally, the disposable part may contain absorbent material. Optionally, the absorbent material may include a medical sponge. In some embodiments, the sponge may be protected by a housing. For example, the housing may be made of a rigid material, such as rigid plastic. Optionally, the contour of the housing may be adapted to the user's body (e.g., adapted to the genital area of ​​a female or male subject). Optionally, the housing may be covered with sponges on three sides and / or have an opening on one side. For example, the sponge can be exposed to urine through the opening. Optionally, the shape of the housing may be designed so that its opening conforms to the patient's genital area. Optionally, the opening may be completely or partially surrounded by an adhesive.

[0065] In some embodiments, the system may include an overflow release device. For example, the overflow release device may include an opening provided on the housing through which excess urine can be discharged when the urine volume exceeds the detection requirement and / or the sponge reaches saturation. Optionally, the overflow release device may include an opening provided on the housing and / orA conduit for guiding overflow to a location easily accessible for treatment.

[0066] Alternatively, or additionally, the housing may be a flexible structure and / or have flexible portions. Optionally, the housing may include an adhesive and / or partially adhesive patches. In some embodiments, the housing may be at least partially made of the following materials: bakelite, epoxy resin, phenolic plastic, polyurethane, melamine, polyethylene terephthalate (PETG), polycarbonate (PC), polyvinyl chloride (PVC), acrylic and / or polyethylene terephthalate (PET), elastomer, latex, or any combination thereof.

[0067] In some embodiments, the housing may be transparent and / or may include one or more transparent portions. Optionally, the housing may comprise one or more layers, such as plastic, unidirectional fabric, etc. Optionally, the housing is at least partially opaque to liquids. The reusable portion may be a rigid component to accommodate the disposable portion.

[0068] According to some embodiments, the system may also include a standard diaper. Optionally, the disposable portion may be worn inside a standard diaper, close to the subject's genital area. After urine is absorbed by the disposable portion, it can be removed from the reusable portion.

[0069] According to some embodiments, the system may include a medical sponge. Optionally, the reusable portion of the system may include a medical sponge. The medical sponge absorbs urine without reacting with urine components, such as a melamine sponge. Optionally, the medical sponge may include an indicator. For example, a volume indicator may provide the patient or caregiver with an indication that a sufficient amount of urine has been collected, so that the user and / or caregiver knows when to remove the system to extract and / or analyze the urine. Optionally, the volume indicator may protrude from the disposable portion, the reusable portion, and / or the diaper. Optionally, the indicator may provide a visual indication of the amount of urine collected and / or the nature of the urine.

[0070] According to some embodiments, the sponge can rapidly absorb urine, thereby keeping the urethra dry. Optionally, the sponge can absorb a large amount of liquid, for example, it can absorb liquid equivalent to the volume of the sponge. Optionally, the sponge can contain urine within the sponge without releasing it. Optionally, the sponge can release the stored urine when compressed. Optionally, the sponge can partially and / or completely release the stored urine. Optionally, the sponge can completely release the absorbed urine when compressed. Optionally, the sponge's extraction rate can be greater than 85%, and / or greater than 90%, and / or greater than 95%.

[0071] According to some embodiments, the sponge can store a certain volume of urine. Optionally, the amount of urine stored can be from 15ml to 25ml, and / or 20ml to 30ml, and / or 30ml to 50ml, and / or 50ml to 150ml.

[0072] According to some embodiments, the sample volume required for analysis (e.g., chemical detection, biological detection (e.g., culture detection), etc.) may be 5 ml to 10 ml, and / or 7 ml to 15 ml, and / or 10 ml to 25 ml.

[0073] According to some embodiments, a volume indicator may siphon a predetermined volume of urine from the sponge. Optionally, siphoning a predetermined volume of urine from the sponge does not affect system functionality. Optionally, the predetermined volume may be approximately 1 ml to 3 ml, and / or 3 ml to 5 ml, and / or 5 ml to 10 ml. Optionally, when urine reaches the volume indicator, a reaction may be triggered, thereby producing a visible indication. Optionally, the volume indicator may visually indicate that the sponge has collected enough urine for analysis, for example, if the volume indicator is in an "on" state (i.e., urine has reached the volume indicator and triggered a reaction, thereby producing a visible indication), then the amount of urine collected in the sponge is sufficient for analysis.

[0074] According to some embodiments, a wick and / or indicator may draw a predetermined volume of urine from the sponge by wick action. Optionally, the core can be implemented using a core material. Optionally, the core material can be derived from within the sponge. Optionally, the core material can contact the sponge. Optionally, the core material can be partially and / or completely encased in a tube. Optionally, the core material can terminate at the exterior of the sponge, and / or the outer shell, and / or the diaper. Optionally, the core material can terminate in an indicator material. Optionally, the indicator material can be a color-changing material. Optionally, the core material can be used as a volume indicator.

[0075] According to some embodiments, the core material can guide liquid (e.g., urine) from the sponge to the indicator material. Optionally, the core material can be hydrophilic, for example, wettable. Optionally, the core material can be wicked by capillary action through its internal structure (e.g., fibers and / or mesh structures). Optionally, the core material can rapidly absorb urine from the sponge, for example, within 10 minutes, and / or within 5 minutes, and / or within 3 minutes. Optionally, the core material has liquid retention properties to ensure that the amount of urine siphoned from the sponge is minimized, for example, without significantly reducing the sample volume. Optionally, the core material may be at least partially composed of polyvinyl alcohol (PVA), polyamide, cotton, wool, or any combination thereof.

[0076] According to some embodiments, the core material may be partially and / or completely enclosed in a tube. Optionally, the tube may be flexible. Optionally, the tube may be configured to contain the core material. Optionally, the tube may be configured to prevent urine from contacting the diaper, clothing, and / or bedding as it leaves the sponge, and / or the outer shell, and / or the diaper. Optionally, the tube may be configured to assist the core via capillary action. Optionally, one end of the tube may be open. Optionally, both ends of the tube may be open. Optionally, one end of the tube may be open (e.g., inside the outer shell, i.e., where the core contacts the sponge, or inside the sponge, etc.), and the other end may be closed (e.g., where the core reaches, contains, and / or contacts an indicator material).

[0077] According to some embodiments, the tube may comprise a flexible material. Optionally, the tube may comprise a material that is inert when in contact with human skin. Optionally, the tube may be impermeable to liquids, such as water, urine, sweat, etc. Optionally, the tube may be made of various polymers, such as polyvinyl chloride (PVC), polyethylene (PE), silicone, polytetrafluoroethylene (PTFE), etc., or any combination thereof. Optionally, the diameter of the tube may be configured to reduce the amount of urine drawn. Optionally, the diameter of the tube may be configured to enhance capillary action. Optionally, the diameter of the tube may be in the range of 0.5 mm to 1 mm, and / or 1 mm to 3 mm, and / or 2 mm to 4 mm.

[0078] According to some embodiments, the indicator may comprise a material that changes color upon contact with urine. Optionally, the material may be selected from ninhydrin, fluorescein isothiocyanate (FITC), azo dyes, water-sensitive inks, universal pH indicators, or any combination thereof. Optionally, the indicator may provide an indication of the pH value of urine. Instruction manual 6 / 24 pages 9 CN 121079058 A

[0079] According to some embodiments, one or more surfaces of the sponge may be covered with a covering material. Optionally, the covering material may prevent and / or reduce irritation upon contact with the user's skin. Optionally, the covering material may be non-porous. Optionally, the covering material may be porous in one direction. Optionally, the covering material may be porous. Optionally, the covering material may be configured to facilitate the free entry and / or exit of urine into and / or from the sponge. Optionally, the covering material may be hydrophobic. Optionally, the covering material may repel water-based solutions, such as urine; for example, the covering material may not absorb urine but instead deliver urine to the sponge for sample collection for analysis. Optionally, the covering material may not interact with and / or interfere with the chemical properties of urine. Optionally, the covering material may be safe for use on human skin. Optionally, the covering material may not cause irritation to human skin. Optionally, the covering material may be soft, comfortable, and / or flexible. Optionally, the covering material may be fixed to the sponge. Optionally, the covering material can be fixed to the sponge without adding an adhesive that may contaminate the urine sample.

[0080] According to some embodiments, the covering material can be made of fabric. Optionally, the fabric can be nonwoven. Optionally, the fabric can be made of a hydrophobic material, such as polypropylene (PP), modified cellulose, etc. Alternatively or additionally, the fabric can be a hydrophilic material coated with a hydrophobic substance (e.g., wax, paraffin, oil, etc.). For example, a paraffin-coated gauze pad. Optionally, the covering material can be configured to facilitate breathability and / or drainage, and / or non-adhesive to the user's skin. Optionally, the covering material can contain pores of sufficient size to allow the passage of liquids (e.g., urine).

[0081] According to some embodiments, the system or a portion thereof can be sterilized before use. Optionally, the medical sponge can be...Sterilize before use. Optionally, sterilization may include heating in an autoclave at 120°C. Optionally, the sponge may not interact with and / or affect the chemical parameters of the liquid, such as acidity (pH), nitrite, ketone bodies, ketones, sugars, glucose, urobilinogen, bilirubin, proteins, white blood cells, leukocytes, erythrocytes, etc., and / or any combination thereof. Optionally, the sponge surface may contain one or more indicators. Optionally, the sponge may not interact with the indicators. Optionally, the sponge may wet the indicators, for example, by allowing urine to flow over the indicators, by gently compressing the sponge, etc. Optionally, the sponge may be suitable for adding a substrate for bacterial growth (e.g., LB agar, etc.). Optionally, bacteria may grow on the sponge surface away from the patient's anatomy. Optionally, the sponge may promote the culture of bacteria in urine on the substrate surface, thereby quantitatively identifying bacteria in urine.

[0082] Advantageously, the medical sponge may include a convenient sterilization option, rapidly absorb urine, completely release urine under vacuum conditions, and not damage the bacterial community. Furthermore, this sponge may be relatively inexpensive compared to other specialized medical sponges.

[0083] According to some embodiments, the medical sponge containing urine can be moved to an external device for detection. Optionally, urine can be extracted from the sponge, for example, by squeezing. Optionally, the urine extracted from the sponge can be sent for detection. Optionally, the sponge can provide a substrate for chemical and / or biological detection. Optionally, detection can be performed in situ and / or ex-situ. Optionally, the sponge may contain one or more indicators, for example, for chemical and biological detection. Optionally, the sponge may contain a culture medium (culture) for culturing bacteria to detect the presence of bacteria. Optionally, after the urine is absorbed, a culture medium (culture) for culturing bacteria can be applied to the sponge to detect the presence of bacteria.

[0084] According to some embodiments, the system can release urine into a standard sterile vacuum test tube for urine testing (e.g., urine cup testing, test tube, etc.). Optionally, the release of urine allows for convenient sterile urine extraction without human contact with the urine.

[0085] According to some embodiments, the system may include one or more independent diagnostic tests. Optionally, parameters in routine urine tests may include various indicators (e.g., color-changing agents for identifying parameters). Optionally, the system may provide indications of various chemical parameters, for example, indicating abnormalities. Optionally, the system may provide indications of normal and / or abnormal states of microbial contamination (e.g., type and quantity of microorganisms). Optionally, indicators may be added with a sponge that ensures the indicator is completely wetted. Optionally, the system may include a device made of a transparent material.A window is provided to facilitate reading color changes. Optionally, the system may include a window made of a transparent material to facilitate determining the amount of urine collected.

[0086] Alternatively and / or additionally, once an indication of chemical parameters is obtained, urine may no longer be needed, and the urine may then interact with one or more substances that absorb liquid in an irreversible manner, such as polyacrylates, polyols, etc., as seen in conventional diapers. These substances absorb urine rapidly and irreversibly, keeping the area dry.

[0087] According to some embodiments, the medical sponge and / or urine-absorbing material may contain ectopic culture diagnostics, for example, combining polyacrylate-polyol with LB agar, which can promote the growth of bacterial communities. Optionally, if bacteria are present in the urine, they can be cultured into visible colonies within one day (at a temperature of 37°C). Optionally, such a test can exclude the detection of bacteria in the urine below an allowable threshold, thereby ruling out bacterial contamination.

[0088] According to some embodiments, the system may include a urination indicator. Optionally, the system may include a sensor (e.g., a humidity sensor, an electrical conductor, etc.). Optionally, the sensor may detect the start and / or end of urination. Optionally, the sensor may provide a prompt (e.g., an audible prompt, a visual prompt, etc.) at the start and / or end of urination.

[0089] In some embodiments, the sponge may include an isolation layer. For example, the isolation layer may include a layer located between the sponge and the subject. Optionally, the isolation layer may divert the first stream of urine and / or guide midstream urine to the collecting sponge. For example, midstream separation may include a layer located between a biocompatible layer and / or the user's skin and the sponge. Alternatively or additionally, the biocompatible layer may be located between the isolation layer and the sponge. One option for the layer is a dissolving layer that dissolves upon contact with a small amount of urine. Alternatively or additionally, the isolation layer may absorb the first stream of urine, allowing subsequent (midstream) urine to reach and / or be collected by the sampling sponge.

[0090] According to some embodiments, the system is suitable for urine chemical and biological detection, such as bacterial culture. According to some embodiments, the system can be easily used after a brief tutorial. According to some embodiments, the system is comfortable to wear and does not cause pain and / or discomfort. According to some embodiments, the system can provide urination indication. According to some embodiments, the system can be inexpensive and / or easy to manufacture.

[0091] According to some embodiments, the system may include a sponge. Optionally, the sponge may be biocompatible. Optionally, the system may include a dedicated layer for separating midstream urine. Optionally, the system may include a dedicated layer for isolating the sponge from the subject's body. Optionally, the system may include a biocompatible buffer layer. Optionally, the system may include a separation cap. Optionally, the system may include a midstream buffer layer. Optionally, the system may include an indicator.

[0092] According to some embodiments, the system may include a biocompatible layer. Optionally, the system may include a mid-section isolation layer. Optionally, the mid-section isolation layer may be located between the biocompatible layer and the sponge. According to some embodiments, the system may include a first layer, followed by a biocompatible layer, and then a sponge.

[0093] According to some embodiments, the mid-section isolation layer and / or the biocompatible layer may be a dissolving layer. Optionally, the dissolving layer dissolves upon contact with urine.

[0094] According to some embodiments, the system may include a device configured for extracting urine from a urine collection system. Optionally, the urine extraction device may be configured to extract urine in a simple, efficient, and safe manner without compromising the integrity of the sample.

[0095] According to some embodiments, the system may include a urine collection cup. In some embodiments, the system may extract urine from the sponge into a standard urine sample cup. Optionally, the system may be used in medical facilities. Optionally, the system may be used for home care. Optionally, the system may be portable. Optionally, the system may facilitate urine testing. Optionally, the urine sample detection, as described on page 8 / 24 of CN 121079058 A, can be a chemical detection (e.g., chemical analysis, pH value, etc.) and / or a biological detection (e.g., microbial detection, including bacterial inoculation capacity, culture capacity, and analytical capacity, etc.).

[0096] According to some embodiments, the system may include a urine collection cup equipped with a designed cap. Optionally, a urine collection sponge may be placed in the urine collection cup and covered by the designed cap. Optionally, the cap may be installed in the device. Optionally, urine can be extracted and collected into a sterile urine collection cap by squeezing the sponge. Optionally, the device can conveniently extract urine from multiple samples simultaneously. Optionally, squeezing can be automatic and / or manual operation.

[0097] According to some embodiments, the system may include one or more diagnostic methods for determining the characteristics of squeezed urine samples. Optionally, the system may include functions such as microbial detection, chemical detection, and image analysis. Optionally, chemical image analysis can be used to analyze the color, clarity, and other relevant parameters of urine and can provide results quickly. Optionally, bio-imaging analysis can be used to capture images of cultured samples.

[0098] In some embodiments, the system may include a urine extraction system. Optionally, the extraction process may be automated or manual. The extraction system may optionally include an indicator and / or a reader. For example, the indicator may be a chemical indicator (such as a test strip, diagnostic device, chemical analyzer, or indicator), a biological indicator (such as an antibody test, rapid diagnostic test, or biosensor), and / or a quantitative indicator. In some embodiments, the tester and / or reader may be distributed between the sampler and the extraction system. For example, the sampler may include a built-in chemical indicator, and / or the extraction system may include a reader for reading the chemical indicator results.The extractor (e.g., a detector (e.g., an optical detector for sensing the color of an indicator) and / or a processor for interpreting sensor data (e.g., converting the detected color into an estimated characteristic of the urine)). In some embodiments, the tester may be permanently built into the extraction system. Alternatively or additionally, the tester may be modular. For example, the extraction system may include a support for housing interchangeable testers. For example, interchangeable testers may include different indicators (e.g., different test strips and / or different indicator chemicals and / or different antibody tests), and / or the tester may include connectors for connecting the extraction system to different testing devices (e.g., automated analyzers and / or sensors, etc.).

[0099] According to some embodiments, the system may be configured to interpret test results using artificial intelligence (AI). Optionally, the AI ​​algorithm may compare images and / or data obtained from a urine sample with known parameters and / or protocols to generate accurate and reliable test results.

[0100] According to some embodiments, the system may include data storage capabilities. Optionally, the system may facilitate the maintenance of test result records. According to some embodiments, the system can support secure data transmission, for example, for access and analysis of data by healthcare professionals and clinics.

[0101] According to some embodiments, the system can be low-cost and / or easy to manufacture.

[0102] Exemplary Embodiments Before detailing at least one embodiment of the invention, it should be understood that the application of the invention is not necessarily limited to the specific construction and arrangement of the components and / or methods shown in the following description and / or drawings and / or embodiments. The invention may have other embodiments or may be implemented or carried out in various ways.

[0103] Some embodiments relate to a system and method for collecting and storing urine without invasive medical procedures while keeping the urine sterile for use in medical examinations, such as chemical detection, culture, etc. According to some embodiments, the system may include disposable components and reusable components. Optionally, the disposable component may include a medical sponge. In some embodiments, the sponge may be partially enclosed within a shell. Optionally, the shell may partially and / or completely surround the sponge. In some embodiments, the shell may be a transparent and / or flexible material. Optionally, the shell may consist of one or more layers of plastic and / or unidirectional fabric. Optionally, the reusable component may be a rigid reusable component that mates with a disposable component. Optionally, the system may also include a standard diaper. Specification 9 / 24 pages 12 CN 121079058 A

[0104] Referring now to the drawings: FIG1 is a schematic diagram of a system for collecting and storing urine according to some embodiments. For example, the system may include a dedicated sponge 1 that absorbs urine without affecting the composition of the urine and / or test parameters. Optionally, the volume of the sponge may beThe volume can be between 10 ml and 30 ml, 30 ml and 60 ml or 60 ml and 120 ml. Optionally, the sponge may include a surface 2 for culturing bacteria. Optionally, the culture surface may be located away from the patient's body. Optionally, the area of ​​the culture surface may be between 1 cm2 and 2 cm2, 2 cm2 and 4 cm2, or 4 cm2 and 8 cm2. Optionally, the culture surface may include LB agar, which may be suitable for forming visible bacterial colonies within 6 hours at a temperature of 37°C. Optionally, the sponge may include one or more indicators 3 for chemical testing. Optionally, a sound sensor 4 may also be included. For example, an audible alert may be given at the end of urination, such as when the urine is conductive. Optionally, a sealed transparent plastic shell 5 may enclose the sponge containing the sensor. Optionally, the plastic shell may include an opening suitable for the urethra. Optionally, the plastic shell may include a reversible adhesive 6 for securing the opening to the skin.

[0105] Figure 2A is a schematic diagram of a system for collecting and storing urine according to some embodiments. For example, the system may include a dedicated sponge 1 that absorbs urine without affecting the composition of the urine and / or test parameters. Optionally, the sponge may include a surface 2 for culturing bacteria. Optionally, the culture surface may be located away from the patient's body part 9. Optionally, the culture surface may include LB agar, which is suitable for culturing visible bacterial colonies at a temperature of 37°C for 6 hours. Optionally, the sponge may include one or more indicators 3 for chemical testing. Optionally, a sensor 4 may also be included for indicating the end of urination, for example, by providing an audible alert when urination is complete, such as when the urine is conductive. The system may be attached to a human and / or animal, for example, using adhesives and / or elastic members and / or straps and / or some form of clothing and / or diapers.

[0106] Figure 2B is a schematic diagram of an embodiment of the present invention. In some embodiments, a sponge 202 partially encased in a shell 204 may be placed in the path of urine flow 203 (e.g., the urine flow path of a dog 205). Optionally, the outer shell 204 protects the sponge 202 from contamination (e.g., contact with the ground and / or litter box) and / or collects urine into the sponge 202. Optionally, the outer shell 204 may have an opening, for example, for allowing urine to reach the sponge. Optionally, a cover may also be provided. For example, the cover may be a quick-release cover (e.g., peelable) and / or a replaceable cover (e.g., a plastic cap that can be removed after urine collection or replaced during storage and / or transport) and / or a dissolvable cover (e.g., the cover dissolves when urine covers it, thereby protecting the sponge 202 before urination and allowing urine to reach the sponge 202 during urination, such as midstream urine).

[0107] In some embodiments, the outer shell 5 may wrap around the sponge from three sides. For example, the outer shell may be a sealed, transparent cover.And / or made of plastic. The housing may contain a sensor. Optionally, the plastic housing may contain an opening adapted to the urethra. Optionally, the plastic housing may contain a reversible adhesive 6 for attaching the opening to the skin. Optionally, a rigid plastic frame 7 may detachably house the plastic housing, a test sponge (adapted to the subject's body structure), and / or other wrapping layers, such as swaddling clothes. Optionally, the system may also contain a standard diaper 8.

[0108] FIG2B is a schematic diagram of a system for collecting and storing pet urine according to some embodiments.

[0109] FIG3A-FIG3H are schematic diagrams of applications of a system for collecting and storing urine according to some embodiments. For example, an elastic, flexible plastic housing 32 and / or frame 30 are provided to fit the subject's body. The housing 32 may be selectively opened (e.g., as shown in FIG3A-FIG3D) and a disposable device (e.g., a sponge) may be unfolded and / or inserted therein (e.g., as shown in FIG3D). The housing 32 can selectively close the covering device 34 (e.g., as shown in Figures 3E-3H, in an elastic, manual, or other manner). In some embodiments, the frame 30 can be opened and / or placed on the user. For example, the frame 30, housing 32, and / or the device 34 can be elastically secured to the user when the deformed frame 30 returns to its resting shape and / or grips the user's body (e.g., as shown in Figures 3G and 3H). Optionally, the disposable device 34 may include one or more testing devices. Additionally or alternatively, the device 34 is inserted into the housing 32 (e.g., a plastic housing) (e.g., Figures 3D-3F). The disposable device can be selectively placed on the subject's body 35, optionally adhered in place, and a standard diaper 36 is applied thereon (e.g., Figures 3G-3H).

[0110] Figures 4A-4B are three-dimensional schematic diagrams of a system for collecting and storing urine according to some embodiments. For example, the system may include a standard diaper, a rigid plastic shell 40, and / or a frame 46. Optionally, the frame 46 may conform to the body structure of the subject and / or fit the standard diaper. In some embodiments, the shell 40 forms an additional container (e.g., a volume between 50 and 70 ml and / or between 20 and 50 ml and / or between 70 and 100 ml). The shell 40 may include a cover 44 suitable for a sponge 41. The shell may selectively fit the diaper. For example, when properly positioned, the diaper is closed, and the urethra is located directly in front of the opening 42.

[0111] Figures 5A and 5B are three-dimensional schematic diagrams of a system for collecting and storing urine according to some embodiments. For example, the system includes a sponge 60. For example, the volume of the sponge 60 may be between 50 and 70 ml and / or between 20 and 50 ml.Between 70 and / or 100 ml. Optionally, the sponge 60 may be enclosed in the housing 56. In some embodiments, the housing 56 may be sealed, transparent, and / or made of plastic. Optionally, a cap 52 covers the open side of the housing 56. In some embodiments, the cap may include an opening 57. For example, urine can reach the sponge through this opening. Optionally, a gasket 58 is disposed around the user's urethral opening and / or guides urine to the sponge and / or protects the urine from contamination and / or reduces wetting of the subject, diaper, and / or clothing. The housing 56 may be secured in place by a frame 54.

[0112] FIG5A is a three-dimensional schematic diagram of the sponge inserted into the hard housing; FIG5B is a three-dimensional schematic diagram of the housing containing the sponge, wherein when the urine absorption opening (part of the sponge housing) is adjusted to the opening of the hard housing, the urine absorption opening is located around the urethra when the diaper is closed.

[0113] According to some embodiments, the system may also include an audible indicator that can be activated when urine wets the sponge. Optionally, the circuit can be closed to activate the sound indicator when the sponge is wetted. Optionally, the sound indicator may include a button battery. Optionally, the sound indicator may be located inside the sponge.

[0114] According to some embodiments, the system may include an indicator (color) for urine chemical analysis. Optionally, the indicator may be located on the surface of the sponge (e.g., between the sponge and the transparent plastic shell) so that the various colors presented by the indicator can be observed and / or photographed after the test. Optionally, the final color of the indicator can be identified by an application.

[0115] According to some embodiments, the system may include a surface for culturing bacteria, for example, 4 cm2. Optionally, LB agar may be suitable for forming visible bacterial colonies within 6 hours at a temperature of 37°C. Optionally, LB agar may be placed on the surface of the sponge (e.g., between the sponge and the transparent plastic shell) to promote microbial growth. For example, bacterial colonies (or no colonies) can be observed and / or photographed after sampling and after an incubation period (e.g., about 6 hours at about 37°C). Optionally, the obtained colonies can be identified using an application.

[0116] Figures 6A-6G are schematic diagrams of methods for collecting, storing, and extracting urine according to some embodiments. For example, the method includes opening a diaper 62 and removing a disposable device (e.g., Figures 6A-6C) from a housing 61 and a frame 63. The disposable device is placed on a support 65. Optionally, the support includes a downward-facing opening (e.g., Figures 6D-6E). In some embodiments, a sponge 60 is compressed within the support 65, for example, through a baffle 64 of the support. Squeezing the device may optionally enhance the wettability of a test indicator 68 and / or a substrate for bacterial growth (e.g., Figures 6F-6G). Optionally,Take a photograph of the indicator and / or create a control table. Optionally, send the device, control table, and / or photograph to a medical professional for comment. Optionally, compression may extract urine into a container for testing. Optionally, incubate the disposable device at approximately 37°C for more than 6 hours. Optionally, photograph the substrate after incubation and compare it with a standard, and optionally submit it to a medical professional for evaluation. Instruction manual 11 / 24 pages 14 CN 121079058 A

[0117] According to some embodiments, the method of using the system may follow at least some of the following steps: • Open the hard plastic shell and disposable device suitable for the subject's body.

[0118] • Insert the test device into the plastic shell, with the urine inlet nozzle protruding from the inside to the outside.

[0119] • Place the test device on the subject, disinfect the urethra with disinfectant gel, and secure the urine inlet nozzle.

[0120] • Put on a standard diaper.

[0121] • Remove the diaper after hearing a urination sound.

[0122] • Remove the disposable test device from the plastic casing, with the urine inlet facing upwards as much as possible.

[0123] • Place the disposable device on the stand with the opening facing upwards.

[0124] • Squeeze the sponge to fully wet the indicator and / or bacterial substrate.

[0125] • After 60 seconds, take a photograph of the indicator (for comparison with a reference table or for application analysis).

[0126] • Submit for medical advice.

[0127] • Store the disposable device at a temperature of 37°C for more than six hours.

[0128] • After storage for more than six hours, take a photograph of the bacterial substrate for application analysis.

[0129] • Submit for medical advice.

[0130] • Discard the disposable device.

[0131] FIG7 is a block diagram of a system for collecting and storing urine according to some embodiments of the present invention. For example, system 700 may include a casing 702. Casing 702 may optionally be flexible, plastic, and / or transparent. System 700 includes a sponge 704 (e.g., a medical sponge). The sponge 704 is optionally protected and / or partially surrounded by a shell 702. The sponge 704 may contain one or more tests, such as a chemical test 710, a bacterial substrate 712, a sensor 714, and / or any combination thereof. Optionally, the sensor 714 can detect the start and / or end of urination. Optionally, the sensor 714 can provide a cue 716 (e.g., an audible cue, a visual cue, etc.) at a stage of urination (e.g., the start of urination, the point of reaching a predetermined humidity threshold, and / or the end of urination). System 700 may include a frame 706. Optionally, the frame 706 may be a rigid and / or reusable frame; alternatively and additionally, the frame 706 may be disposable and / or flexible and / or adjustable. For example, the frame...The system can be secured in place using an adhesive. Optionally, a diaper 708 can cover the entire system. The diaper 708 can include standard and / or commercially available diapers, and / or the diaper can be provided by the user.

[0132] FIG8 illustrates a flowchart of a method for collecting and storing urine according to some embodiments of the present invention. Various embodiments of the present invention may include some or all of the steps in exemplary method 800. In some embodiments, a medical sponge 806 is placed on a subject (e.g., near the urethral opening). Optionally, the sponge 808 can be secured by adhesiveting the device into place. Alternatively, the method may include unfolding a plastic shell and / or inserting the medical sponge into the shell. Furthermore, the device may also be covered by a hard shell. In some embodiments, the user and / or their clothing may be protected by using a standard diaper. Optionally, the device is held in place while collecting 814 a urine sample from the subject. In some embodiments, the urine is tested 816. For example, the test may be performed while the urine is still in the sponge. Alternatively or additionally, the urine may be extracted from the sponge for testing and / or sent to a laboratory for testing.

[0133] FIG9 is a flowchart illustrating a urine collection and testing method according to some embodiments of the present invention. For example, in method 900, a sample is brought into contact with a testing instrument 902. The result of the built-in testing instrument is read 904. An external test is performed 906, and all test results are reported to the user and / or caregiver 908.

[0134] In some embodiments, the sample is brought into contact with a testing instrument. For example, urine can be extracted from a sponge (e.g., by squeezing the sponge) to release the urine into an external testing instrument. For example, the external testing instrument may include test strips, test kits, analyzers, and / or culture media (e.g., a petri dish with growth medium). Optionally and / or additionally, urine may be distributed into a portion of the sponge, housing, and / or sampling device (e.g., distributed into the built-in testing instrument, for example, including test media, devices, and / or test strips). For example, the sponge may include a region containing nutrients (e.g., agar for bacterial growth). For example, the sponge can be squeezed to distribute urine to various parts of the sampler and / or the entire sponge.

[0135] In some embodiments, the sponge may be partially enclosed by a housing. For example, the housing may include an external barrier to protect the sponge from dirt and / or microorganisms and / or prevent urine leakage from the sponge. The housing may be flexible (e.g., paper) and / or soft (e.g., plastic film (e.g., polyethylene (PE), high-density polyethylene (HDPE), polypropylene (PP) and / or PET (polyethylene terephthalate))) and / or elastic (e.g., rubber, elastomer) and / or protective (e.g., high-density polyethylene (HDPE) fiber, Tyvek®).(and / or aluminum foil). Optionally, the housing is designed to allow the sponge to be squeezed without contacting the sponge and / or without removing the sponge from the housing. Alternatively or additionally, the sponge can be removed from the housing for testing and / or urine extraction.

[0136] In some embodiments, a user can read the test results from the integrated testing instrument of the sampling system. In some embodiments, the results can be read by a machine and / or transmitted over a network. For example, a user can photograph a portion of the sampler and read it via the Internet; or the sampler can include a data port and / or a wireless transmitter to transmit the results to the user's device, network, and / or medical personnel. In addition, the user can also hand over a portion of the sampler (e.g., test sticks and / or data storage devices) to a medical personnel for reading and / or downloading the results. Alternatively or additionally, test results can be read using an external device. For example, the sampler can contain a culture medium. Optionally, urine can be inoculated onto a culture medium within the sampling device. Microbial growth can be measured externally (e.g., observing colony growth and / or measuring impedance changes through a window on the sampler). Optionally, the culture medium substrate is maintained at a specific temperature (e.g., about 37°C) by an internal and / or external system. Optionally, identification can be based on colony morphology and / or by means of microscopy and / or inoculation isolation. Detection results may include the presence and / or degree of significant infection and the type of microorganism involved. Optionally, the infection status and / or bacterial identification can be assessed by image analysis (e.g., with the aid of an application).

[0137] In some embodiments, the integrated testing instrument may include chemical / pathogen test strips, culture medium, metabolomics, proteomics, flow cytometry (e.g., detection of cell shape and / or structure and / or DNA, cell cycle, proteins, etc.), immunoassay, nucleic acid amplification (e.g., polymerase chain reaction (PCR) and / or ligase chain reaction (LCR)).

[0138] In some embodiments, samples may be collected from a sampling system and placed into an external testing instrument and / or testing system. Optionally, users and / or medical personnel may read and / or receive results from the external system. In some embodiments, test results may be standardized to account for the impact of sampling.

[0139] In some embodiments, the results may be reported to the user automatically or manually. For example, if the test subject reads the results himself and / or through a machine, he / she and / or the machine may transmit the results to a medical professional and / or a server. For example, if a medical professional reads the results himself and / or through an external machine, he / she and / or the machine may send the results to the test subject and / or his / her representative (e.g., a caregiver and / or a doctor).

[0140] FIG10 is a block diagram of a system for collecting and storing urine according to some embodiments of the present invention. For example, the systemSystem 1000 may include a housing 1002. Optionally, housing 1002 is a flexible and / or plastic and / or transparent material. Optionally, housing 1002 is used to fix the system in position, for example, using an adhesive. System 1000 includes a sponge 1004 (e.g., a medical sponge). Optionally, sponge 1004 includes a covering layer (not shown), and 1004 may be hydrophobic, hydrophobic permeable, and / or hydrophilic. Optionally, sponge 1004 is protected and / or partially surrounded by housing 1002. Sponge 1004 may contact core 1006. Core 1006 may be partially or completely wrapped by a gasket (e.g., tube 1008). Tube 1008 may contain and / or contact and / or connect to indicator 1010. Indicator 1010 may contain a volume indicator (e.g., for indicating when sponge 1004 has collected sufficient urine for extraction and / or analysis (e.g., chemical detection, culture detection, etc.)). Alternatively and additionally, indicator 1010 may include indicators for indicating urine properties (e.g., pH, sugar content, biological materials (e.g., antibodies, pathogens)). Optionally, a diaper (not shown) may wrap the system. Optionally, the diaper may include standard and / or commercially available diapers, and / or may be provided by the user.

[0141] In some embodiments, housing 1002 may include an adhesive area. Optionally, the adhesive area may cover the entire housing and / or a portion thereof. Optionally, the adhesive area may adhere to the user's skin. The system may include a core 1006 encapsulated in a tube 1008. Core 1006 may contact sponge 1004. Tube 1008 may include and / or be connected to indicator 1010. Core 1006 may be made of absorbent material. Core material may be hydrophilic and absorb liquid (e.g., urine) through wetting and / or capillary action. The core material can deliver liquid to the indicator 1010. The indicator 1010 may optionally be encapsulated in an air bubble at the distal end of the tube 1008. The indicator 1010 may also be in the form of powder, beads, granules, coated paper, and / or liquid.

[0142] FIG11 is a flowchart illustrating a method for collecting and storing urine according to some embodiments of the present invention. For example, method 1100 includes some or all of the steps listed. For example, unfolding the adhesive shell 1102, inserting a medical sponge into the shell 1104, positioning the device 1106 on the subject, adjusting the indicator tube 1108, attaching the device 1110 into place, and covering the device with a standard diaper. Indication 1112 indicates that the sponge has collected sufficient urine. Collection 1114 and detection 1116 of the urine collected from the subject.

[0143] FIG12 is a block diagram illustrating a system 1200 for collecting and storing urine according to some embodiments of the present invention.

[0144] In some embodiments, system 1200 may include an absorbent material, such as sponge 1204. For example, the absorbent material may include melamine sponge (e.g., Magic Sponge), cellulose sponge (e.g., medical sponge), dense industrial sponge (e.g., sponge rubber), bath sponge, or polyethylene acrylate sponge. Optionally, the volume of sponge 1204 may be 10 ml to 30 ml, 30 ml to 60 ml, or 60 ml to 120 ml. Optionally, sponge 1204 may include a surface 2 for culturing bacteria. Optionally, the culture surface may be located away from the body structure of the subject. Optionally, the surface area may be 1 cm² to 2 cm², 2 cm² to 4 cm², or 4 cm² to 8 cm². Optionally, the culture surface may include LB agar, suitable for forming visible bacterial colonies.

[0145] In some embodiments, sponge 1204 may be partially surrounded by an outer layer 1202 (e.g., a shell). For example, the outer layer 1202 may include an external barrier to protect the sponge 1204 from dirt and / or microorganisms, and / or prevent urine leakage from the sponge 1204. The layer 1202 may be flexible (e.g., paper) and / or flexible (e.g., plastic film, such as polyethylene (PE), high-density polyethylene (HDPE), polypropylene (PP), and / or PET (polyethylene terephthalate)) and / or elastic (e.g., rubber, elastomer) and / or protective (e.g., high-density polyethylene (HDPE) fibers, Tyvek®, and / or aluminum foil). Optionally, the layer 1202 may be designed to allow the sponge 1204 to be squeezed without direct contact with it and / or without removing it from the layer 1202. Alternatively, the sponge 1204 may be removed from the layer 1202 for testing and / or urine extraction. Optionally, the layer 1202 may be transparent, translucent, and / or opaque.

[0146] Optionally, the contours of layer 1202 and / or sponge 1204 may be designed to conform to the user's body (e.g., to the genital area of ​​a female or male subject). Optionally, three sides of layer 1202 surround sponge 1204 and / or an opening is provided on one side. For example, sponge 1204 can contact urine through said opening. Optionally, the opening of layer 1202 may be designed to face the patient's genital area. Optionally, said opening may be completely or partially surrounded by an adhesive.

[0147] According to some embodiments, sponge 1204 may be made of a material that does not interact with and / or affect the chemical parameters of the liquid, such as acidity (pH), nitrite, ketones, sugars, glucose, urobilinogen, bilirubin, proteins, white blood cells, red blood (erythrocytes), etc., or any combination thereof.

[0148] Optionally, the surface of sponge 1204 may contain one or more indicators 1210. Optionally, sponge 1204 may not...Interacting with indicator 1210. Optionally, sponge 1204 may wet indicator 1210, for example by allowing urine to flow through indicator 1210, slightly compressing sponge 1204, etc. Optionally, indicator 1210 may be a substrate for bacterial growth (e.g., LG-agar, etc.). Optionally, bacteria may grow on the surface of sponge 1204 away from the patient's anatomy. Optionally, indicator 1210 may promote the culture of bacteria in urine on the substrate surface, thereby enabling quantitative identification of bacteria in urine.

[0149] In some embodiments, in certain cases, indicator 1210 may comprise a separate diagnostic test. Optionally, parameters in routine urine tests may comprise various indicators 1210 (e.g., color-changing materials for identifying the parameter). Optionally, system 1200 may provide indication of various chemical parameters, such as areas that may indicate abnormalities. Optionally, system 1200 may provide indications of normal and / or abnormal states of microbial contamination (e.g., type and quantity of microorganisms). Optionally, indicator 1210 may be added when the sponge ensures the indicator is fully wetted. Optionally, system 1200 (e.g., outer layer 1202) may include a window made of a transparent material to facilitate reading color changes. Optionally, the system may include a window made of a transparent material to facilitate determining the amount of urine collected.

[0150] According to some embodiments, sponge 1204 and / or indicator 1210 may contain ex-situ culture diagnostics, such as polyacrylate-polyol combined with LB agar to promote bacterial population growth.

[0151] In some embodiments, indicator 1210 will include a humidity indicator. For example, an audible cue may be triggered when the desired amount of urine is absorbed, and / or a visual indicator 1210 (e.g., color change) may be triggered.

[0152] In some embodiments, system 1200 may include various optional components. For example, sponge 1204 may include a cover layer that may be hydrophobic, hydrophobic, and / or hydrophilic. Sponge 1204 may contact the core. For example, the core may be partially or completely wrapped by a gasket. The gasket may contain and / or contact and / or be attached to a volume indicator 1210. The volume indicator 1210 may indicate when sponge 1204 has collected sufficient urine for extraction and / or analysis (e.g., chemical assay, culture assay, etc.). Optionally, a diaper (not shown) may wrap the system. Optionally, the diaper may include standard and / or commercially available diapers, and / or may be provided by the user.

[0153] Figure 13 is a schematic diagram of a urine collection system according to some embodiments. For example, the urine collection system may includeOuter layer (shell) 1306. In some embodiments, the outer layer 1306 may completely and / or partially surround the sponge 1302 from one, two, three, four, five, and / or six sides. For example, in the embodiment shown in FIG13, the outer layer 1306 completely covers the dorsal, lateral, underside, and upper side of the sponge 1302, while the ventral side is not covered. Alternatively and additionally, the outer layer may also partially cover the ventral side of the sponge 1302 and / or include an opening positioned above the user's urethral opening.

[0154] In some embodiments, the edges of the outer layer 1306 include an adhesive. For example, the adhesive surrounds the sides, underside, and upper side of the sponge 1302. (Alternatively and additionally, the adhesive surrounds the sides, underside, and above the openings on the ventral side of the outer layer 1306.) Optionally, the outer layer 1306 is configured such that when the adhesive adheres to the skin around the subject's urethral opening, the sponge 1302 is exposed to the urethral opening, allowing the inner sponge 1302 to absorb and contain urine, while the adhesive prevents urine from leaking outwards. Optionally, the outer layer 1306 includes an overflow drain. For example, an incision 1304 and / or an adhesive-free area may be provided to allow excess urine to drain from the pad.

[0155] FIG14 is a schematic diagram of various coverings of a sponge according to some embodiments. For example, each sponge 1402 may include one covering. Optionally, the covering comprises a nonwoven fabric. Optionally, the covering may be a hydrophobic covering 1404 (made of impermeable fabric), a hydrophobic and permeable covering 1406 (made of permeable fabric), and / or a hydrophilic fabric 1408. Urine can bypass the nonwoven cover layer (impermeable, hydrophobic 1404); pass through the cover layer without wetting it (permeable, hydrophobic 1406); or wet the cover layer and further wet the underlying sponge (hydrophilic 1408).

[0156] The pores of the fabric cover layer can be large enough to allow urine 1410 to pass through. Alternatively, a hydrophobic material can be used to prevent the fabric itself from absorbing urine 1410. Alternatively, the hydrophobic nonwoven fabric 1404 can prevent urine 1410 from penetrating into the sponge. However, the sides (thickest parts) of the sponge 1402 may come into contact with urine 1410, and these sides may not come into contact with the skin. Alternatively, a hydrophilic fabric 1408 can be used, which itself can absorb some urine 1410, but the amount absorbed is insufficient to affect the collection of urine 1410 by the sponge 1402. Alternatively or additionally, the hydrophilic fabric 1408 may absorb the first stream of urine, thereby facilitating the entry of midstream urine into the sponge 1402.

[0157] Figures 15A-15B are schematic top (back) and side (side) views of an indicating device combined with a collection pad according to some embodiments. For example, the system may include absorbent material (e.g., sponge 1504) and / or a housing 1502. Housing1502 may include an adhesive region 1512. Optionally, the adhesive region 1512 may cover the entire housing and / or a portion thereof. Optionally, the adhesive region 1512 may adhere to the user's skin. The system may include a core 1508 encapsulated in a tube 1506. The core 1508 may contact a sponge 1504. The tube 1506 may include and / or be connected to an indicator 1510. The core 1508 may be made of an absorbent material. The absorbent material may be hydrophilic and may absorb liquids (e.g., urine) through wetting and / or capillary action. The absorbent material may deliver liquids to the indicator 1510. Optionally, the indicator 1510 may be a quantitative indicator and / or encapsulated in an air bubble at the distal end of the tube 1506. Optionally, the indicator 1510 may be in the form of powder, beads, granules, coated paper, and / or liquid.

[0158] Figures 16A-16D illustrate methods of using a clinical urine extraction system according to some embodiments of the present invention. Optionally, multiple urine samples can be extracted simultaneously and / or individually. For example, as shown in FIG16A, the system may include one or more trigger switches (e.g., button 1622). For example, each of the three pistons 1626 includes a trigger button 1622. Optionally, pressing the trigger button 1622 activates the actuator 1623 and / or causes the corresponding piston 1626 to push the compression push rod 1664 toward the sampler (e.g., move downward).

[0159] In some embodiments, the system may include a holder 1628 for placing vials and / or sponges. In some embodiments, pressure can be applied to the pistons 1626 by an electric actuator. Alternatively and additionally, the user may directly press the pistons 1626 to apply pressure, and / or an elastic element (e.g., a spring) may apply pressure to the compression push rod 1664 and / or sponge (e.g., as shown in FIG16B-FIG16D).

[0160] FIG16B and FIG16C illustrate the placement of a sample collector and / or sample cup on an extraction system according to embodiments of the present invention. For example, the support 1628 can fix the sample cup 1668 under each compression pusher. For example, the sample cup 1668 can be a standard sample cup. The device and / or sample cup 1668 can be selectively sterile. The support 1628 can be selectively adjusted to accommodate different types of sample cups. Optionally, a sponge 1602 can be placed on the urine extraction cap (i.e., sponge adapter 1666) of each sample cup 1668.

[0161] Figure 16D shows a schematic diagram of the pusher 1664 squeezing the sponge 1602 according to an embodiment of the present invention. Optionally, each adapter 1666 can be provided with a filter at the opening of the sample cup 1668. The urine collection device (e.g., sponge 1602) can be placed above and / or inside the filter. The pusher 1664 can descend onto the urine collection device and / or squeeze the urine for sampling.A sampler is used to extract collected urine (e.g., introduced into sample cup 1668 via adapter 1666) for analysis.

[0162] FIG16E is a side cross-sectional view of a urine extraction system according to an embodiment of the present invention. FIG16E also shows an enlarged side cross-sectional view of the extraction system of sampler 1603 and pusher 1664. FIG16G is an enlarged perspective view of the extraction system of pusher cushion pad 1674, as shown in an embodiment of the present invention.

[0163] In some embodiments, the collector includes a flexible and / or resilient cover 1677 and / or an absorbent member (e.g., sponge 1602). For example, the collector soaked in sample 1676 is placed on sample cup 1668 with sponge 1602 open toward the inside of cup 1668, and / or with cover toward pusher 1664.

[0164] In some embodiments, pusher 1664 includes a rigid base 1672 and / or cushion pad 1674. For example, push rod 1664 can apply gradually uniform pressure to the sampler to extract urine sample 1676 (e.g., squeeze out from sponge 1602 of sampler 1603). In some embodiments, the cushioning pad can be elastic (e.g., made of rubber and / or elastomer, applying a uniform elastic force when pressed against collector 1603). Alternatively or additionally, the cushioning pad can be sealed (e.g., it can be a closed flexible container, and / or an open flexible container sealed to base 1672), containing a fluid (e.g., air). As push rod 1664 descends, the pressure of push rod 1664 on sampler 1603 squeezes sample 1676 out of sponge 1602, through receiving portion 1682 (e.g., see FIG. 16H) and / or squeezed into cup 1668.

[0165] FIG16H is an enlarged perspective view of an adapter 1666 according to an embodiment of the present invention, for adapting a sampler 1603 to a sample cup 1668. For example, the adapter 1666 may include a base 1678 configured to fit the urine cup 1668. For example, the base 1678 may form the bottom outer periphery of the adapter 1666. The adapter 1666 may optionally include a surface complementary to the push rod 1664. For example, the complementary surface may include a lip and edge surrounding the top surface of the adapter 1666 to prevent urine from overflowing from the adapter 1666, and / or the complementary surface 1680 may be configured to seal against the bottom surface of the push rod 1664.

[0166] In some embodiments, the adapter 1666 includes a sampler holder (e.g., a receiving portion 1682). For example, the receiving portion 1682 may have a notch formed on the top surface of the adapter. The receiving portion 1682 may be configured to engage with the cap 1677 (e.g., its edge) of the sampler 1603. Optionally, the receiving portion is formed on the edge of the recess on the top surface of the adapter, for example, this can suppress urine flow.Overflow from the side of the adapter 1666, and / or hold the sampler in a preferred position that facilitates squeezing. Optionally, the adapter includes a sieve 1684 (e.g., a support surface with drainage holes). The sieve 1684 may optionally form the bottom of a notch on the top surface of the adapter 1666 for supporting the bottom surface of the sampler 1603, and / or itself facilitate squeezing and / or promote the drainage of urine from the sponge 1602 into the cup 1668 below.

[0167] In some embodiments, the adapter 1666 can enhance the versatility of the urine extraction system. For example, by using different adapters, the same urine extraction system and / or sampler can be used to fill cups of different sizes and / or shapes to accommodate different urine testing devices. Different adapters can be used to extract urine from samplers of different shapes and / or sizes (e.g., samplers for large samples, small samples, adults, infants, men and / or women).

[0168] Figures 17A-17E are perspective views of a simplified version of a urine extraction system according to an embodiment of the present invention. For example, the extraction systems of Figures 16A-16H can be used in clinics and / or laboratories, while the systems of Figures 17A-17E can be used for home sampling and / or testing. The systems shown in Figures 17A-17E can be for single use (e.g., packaged in sterile packaging and discarded after a single use). For example, the extraction system may be constructed of molded plastic parts and / or may not contain an electric actuator.

[0169] In some embodiments, the system may include a push rod 1764, a sampler holder 1766, and a test holder 1768. For example, the top surface of the sampler holder 1766 may be provided with a notch and / or opening to secure the sampler (e.g., a squeeze surface on the upper surface of the sampler 1603 and / or similar adapter 1666). Optionally, the components of the system may be connected by guide rails and / or their relative movement may be limited by guide rails. For example, guide rails may be aligned with the push rod 1764 and the sampler holder 1766 to allow the push rod to move along a path toward or away from the sampler. For example, a guide rail can be aligned with the sampler holder 1766 and the test holder 1768 to allow urine squeezed from the sampler to flow to the testing device (e.g., test strip 1788 and / or sample cup). For example, the guide device may include a hinge 1783, a rail, a pin, a gear, etc. Optionally, urine can be squeezed from a urine collection device (e.g., a sponge) by manual squeezing (e.g., pushing a push rod 1764 towards the sampler holder 1766 and / or the sampler 1703 and / or the test holder 1768). Optionally, the push rod 1764 may include a protrusion configured to embed into a notch and / or opening in the sampler holder, thereby squeezing urine from the urine sampler.

[0170] Figures 17B-17D are schematic flowcharts illustrating a home care urine extraction system according to some embodiments of the present invention.Method of use. For example, a chemical test strip 1788 may be placed on a test holder 1768 (e.g., Figure 17B). Optionally, a urine sampler may be placed on a sampler holder 1766 and / or a sample holder 1766, with the sampler located near the test holder 1768 (e.g., Figure 17C). For example, closing the pusher 1864 onto the sampler 1603 squeezes urine from the sampler onto the test holder 1768 and / or the test strip 1788. The test strip is then removed from the urine extraction system and the result is read. Specification 17 / 24 pages 20 CN 121079058 A

[0171] Figure 18 is a schematic diagram of a urine extraction system 1800 according to some embodiments of the present invention. For example, the system includes a urine collection holder 1866. The urine extraction device may include a test holder 1868, for example configured to accommodate a test strip. For example, the test strip may include a pH test strip, a chemical test strip, a biological culture strip, etc. Optionally, the device may include a storage area 1890 for storing system components and / or incubating biological test strips. For example, the incubator may be climate-controlled (e.g., with a heater and / or humidifier). Optionally, the system may include a sterile storage area for storing samples before and / or after extraction.

[0172] Figures 19A-19C are schematic diagrams of a urine extraction system 1900 according to some embodiments of the present invention. For example, the system includes a urine collection holder 1866. The urine extraction device may include a test holder 1868, for example, configured to hold test strips. For example, the test strips may include pH test strips, chemical test strips, biological culture strips, etc.

[0173] In some embodiments, system 1900 may include a digital display 1990. Optionally, the display 1990 may display the test results and / or data of the subject. Optionally, the digital display 1990 may include a user interface 1992. Alternatively or additionally, system 1800 and system 1900 may be connected to an external display, processor, memory, and / or network. For example, the system may include wired and / or wireless interfaces for connecting a user's computing device (e.g., a smartphone and / or personal computer) and / or network (e.g., the Internet). For example, the adapter may include Bluetooth, Wi-Fi, Ethernet, USB connectors, etc. Optionally, system 1900 and system 1800 may include a processor. Optionally, the processor may include memory for data storage. Optionally, the processor may include a communication module. Optionally, the communication module may be configured to transmit test results to caregivers, clinics, etc. Optionally, the processor may include an artificial intelligence algorithm. Optionally, the artificial intelligence algorithm may be configured to analyze test data.

[0174] Figures 19A-19C show a method of using a urine extraction system according to some embodiments of the present invention.For example, a chemical test strip 1788 may be placed on a test holder 1866. A urine sampler (e.g., sampler 1603) may be selectively placed on the sampler holder 1866, and / or the sampler holder may move along a guide rail 1883. A push rod 1864 may be selectively closed to squeeze urine from the urine sampler onto the test strip 1788. The test strip 1788 may be selectively removed from the urine extraction system and the result read, or read in situ automatically and / or manually by the system.

[0175] FIG20 is a block diagram illustrating a urine extraction system according to some embodiments of the present invention. For example, the system may include a urine collection device (e.g., sampler 2003). The sampler 2003 may be selectively placed on a sampler holder 2066 and squeezed between the push rod 2064 and the urine sampler holder 2066. Urine can be collected in a urine collection cup 2069 (e.g., the system can be configured to squeeze urine into a sampling cup of an existing detection system, or the system can be adjusted to squeeze urine into cups of different sizes), and / or can be subjected to chemical and / or biological detection 2092. Detection 2092 can be performed in situ or ex-situ. For example, the urine collection cup and / or detection device (e.g., test strip) can be placed in a test holder 2068.

[0176] FIG21 is a flowchart of a urine detection method according to an embodiment of the present invention. In some embodiments, for example, a urine sample 2102 can be sampled by absorbing urine into a sponge. Optionally, the sponge can be part of a sampler (e.g., a urine sampling device as shown in any of the foregoing embodiments). Optionally, the sampler can be inserted into a detection device 2104. Optionally, urine can be extracted from the sampler 2107. For example, the sampler can be placed under pressure (e.g., squeezed by a push rod). Alternatively or additionally, urine can also be extracted by gravity and / or acceleration (e.g., by centrifugation and / or vibration of the sampler). In some embodiments, the extracted urine can be tested 2109. For example, the test can be performed within the extraction device and / or the urine can be moved to another location and / or the device can be used for testing 2109. Alternatively or additionally, the urine within the sampler can be redistributed using pressure and / or acceleration and / or the test can be performed while the urine is still inside the sampler (e.g., the sampler may include test indicators (e.g., chemical indicators and / or biological indicators (e.g., antibodies)) and / or microorganisms may be incubated within the sampler). Specification 18 / 24 pages 21 CN 121079058 A

[0177] Examples of the embodiments and aspects of the invention described above and claimed in the claims have been experimentally verified in the following examples.

[0178] Reference is now made to the following examples, which, in conjunction with the foregoing description, illustrate several embodiments of the invention in a non-limiting manner. Example 1: Test ChipFigure 22 shows the state of the core before wetting 2202 and after wetting 2204 according to some embodiments. For example, a cotton rope (4 mm thick) is used as the core without any external tube. In alternative embodiments, the core may include absorbent polymers (e.g., sodium polyacrylate (SAP)) and / or cellulose (e.g., wood pulp and / or paper) and / or synthetic fibers (e.g., microfiber) and / or hemp. In alternative embodiments, the core may include an external tube. A thinner cotton rope may be preferred because it absorbs less liquid. For example, the thickness of the core may be in the range of 1 mm to 3 mm, 3 mm to 5 mm, or 5 mm to 10 mm.

[0179] The cotton rope acts as an absorbent core, rapidly drawing liquid along its fibers, reaching about 7 cm within 30 seconds and wetting the indicator test strip. The dry cotton rope (upper part 2202) and the wet cotton rope (lower part 2204) were found to double in weight, increasing from 0.35 g to 0.7 g. For example, a 20cm long cotton rope can only absorb about 1 ml of liquid, which is negligible compared to the amount of sample required for analysis. In alternative embodiments, the dry core weight can be between 0.01 and 0.2 grams, 0.2 and 0.5 grams, 0.5 and 2 grams, or 2 and 10 grams. In alternative embodiments, the core can absorb 10% to 70%, 70% to 150%, or 150% to 300% of its own weight in urine.

[0180] According to some embodiments, a core with a sufficiently small diameter (e.g., a 1mm cotton rope or PVA thread) can be placed inside a tube of appropriate diameter (e.g., a silicone tube with an inner diameter slightly larger than the core diameter). Optionally, the tube can be used to contain liquid (e.g., to prevent liquid from wetting the diaper and / or the patient's skin) and / or to assist capillary action.

[0181] Example 2: Test Core Sampler Figures 23A-23C are images of a core-tube-sponge system according to some embodiments. For example, the system (e.g., FIG. 23A) may include a sponge 2302. Optionally, the proximal end of a tube 2304 containing a core 2310 is inserted into and / or in contact with the sponge 2302. After being soaked in a colored liquid, a portion of the sponge 2302 is wetted with a colored liquid 2308. The liquid 2308 is visible to advance along a portion of the tube (e.g., FIG. 23B). After being soaked in the liquid 2308, the liquid reaches the volume indicator 2312 and begins to accumulate in the hollow portion of the tube 2304 away from the core 2309, causing a color change. The volume indicator 2312 may be encapsulated in an end cap 2306 of the tube 2304. For example, the core 2310 may be a PVA fishing line or a cotton rope placed inside a silicone or PVC tube.

[0182] According to some embodiments, the diameter of the core 2310 may be between 0.4 mm and 0.6 mm, and / or between 0.6 mm and 0.8 mm, and / or between 0.8 mm and 1 mm. According to some embodiments, the inner diameter of the tube can be between 0.5 mm and 1 mm, and / or between 1 mm and 1.5 mm, and / or 1 mm.The outer diameter of the tube can be between 0.5 mm and 3 mm. According to some embodiments, the outer diameter of the tube can be between 0.7 mm and 1.2 mm, and / or between 1.2 mm and 1.8 mm, and / or between 1.8 mm and 3.5 mm. According to some embodiments, the length of the core 2310 can be between 3 cm and 5 cm, and / or between 5 cm and 10 cm, and / or between 10 cm and 20 cm, and / or between 20 cm and 30 cm. According to some embodiments, the core 2310 can be inserted into the tube. Optionally, the core 2310 can be at least partially wrapped by the tube along its length. Optionally, the length of the tube can be between 3 cm and 5 cm, and / or between 5 cm and 10 cm, and / or between 10 cm and 20 cm, and / or between 20 cm and 30 cm.

[0183] According to some embodiments, the system can be calibrated to take into account the tube size and the thickness of the core 2310, both of which can have a significant impact on capillary action, thereby affecting the rate of liquid movement along the tube. Optionally, the volume of liquid contained in the tube is negligible compared to the amount of sample required for analysis.

[0184] In the exemplary embodiments of Figures 23B and 23C, after the sponge is soaked in blue water, the exposed tip of the PVA core 2310 (caught between two sponges – upper and lower) is wetted and begins to dissolve. The liquid is drawn along the core 2310 into the silicone tube and moves with it, dissolving the PVA core 2310. Under experimental conditions, the rate is approximately 1 mm / s, which is quite fast. This effect also occurs when the tube is placed vertically, i.e., the liquid rises against gravity. Once the liquid comes into contact with the indicator paper, the indicator paper is immediately wetted and changes color according to the pH of the solution.

[0185] Example 3: Selection of Applicable Sponges Five types of sponges were tested: melamine sponge (e.g., Magic Sponge), cellulose sponge (e.g., medical sponge), dense industrial sponge (e.g., rubber sponge), bath sponge, and polyethylene acrylate sponge. All sponges were tested for density, liquid absorption capacity, liquid release capacity, and liquid retention capacity (i.e., the dryness around the absorbent material). Table 1 summarizes the test results.

[0186] Table 1: Physical properties of the tested sponges

[0187] According to the data obtained, melamine sponge is superior to other sponges in all parameters: it absorbs more water (the density of saturated sponge exceeds 1 g / ml, while the density of other sponges is less than 0.9 g / ml), meaning that the volume change is negligible; the amount of water it absorbs is approximately equal to its own volume; it does not spontaneously release liquid (it does not drip); and it can release about 90% of the liquid when compressed and / or squeezed. Polyethylene acrylate sponge absorbs a large amount of liquid, more than 20 times its own volume, does not drip, but cannot release liquid when compressed and / or squeezed.

[0188] Example 4 - Influence of substrate on chemical parameter testingSubsequently, melamine sponge and polyethylene acrylate sponge were tested to determine their effects on various chemicals in standard urine tests.

[0189] Urine was tested before and after absorption using standard test strips (7 parameters in total). The test solution was prepared from normal urine and various reagents were added to make its concentration higher than the levels that may occur in urine.

[0190] In this method, normal urine that had undergone routine laboratory testing was aliquoted into 15 test tubes. According to Table 2, reagents were added to the urine to simulate the analytical concentration of the analyte in the urine, making it reach the highest concentration level that may occur in urine in routine testing. Instruction manual 20 / 24 pages 23 CN 121079058 A

[0191] Urine samples were tested using two urine test strips: Aution Arkray test strip and URS-10T urine analysis test strip. The test results are summarized in Table 2.

[0192] Table 2: Effect of Substrate on the Detection Results of Chemical Parameters in Urine

[0193] Table 2 shows that melamine sponge has no effect on the chemical parameters of urine (i.e., the parameters tested in routine tests), while polyethylene acrylate sponge can affect the detection results in some tests. Therefore, melamine sponge is preferred. In some embodiments, the detection results can be standardized, adjusted and / or interpreted according to the volume, contact time, temperature, shape and / or material of the sponge.

[0194] Example 5 - Effect of Collection Sponge on Culture (Bacteria and Fungi) Tests Escherichia coli (E. coli) was added to normal urine at laboratory doses (500 and 1000 bacteria per milliliter), and the urine was soaked on a melamine sponge coated with 2 cm diameter LB agar. A similar procedure was performed on normal urine (without bacteria) (see 2403). Meanwhile, urine containing bacteria and urine without bacteria were inoculated into petri dishes containing LB agar according to standard procedures to detect the presence and quantity of bacteria (colony forming units, CFU). Instruction manual, pages 21 / 24, CN 121079058 A

[0195] A similar experiment was conducted using polyethylene acrylate sponge. Each experiment was repeated three times.

[0196] Test system bacteria: Escherichia coli (Migula, 1895), Castellani & Chalmers, 1919 (ATCC, catalog number 11775).

[0197] Test items: Rona ImedEx sponge treated with Escherichia coli.

[0198] Negative control: Rona ImedEx sponge treated with sterile microbial culture medium Luria Broth (LB).

[0199] Colony forming unit (CFU) count was examined.

[0200] Experimental designAll sponge treatments were performed under aseptic conditions.

[0201] Starting group #1: Escherichia coli (E. coli) was cultured overnight in LB suspension (shaking at 220 rpm).

[0202] Each starting culture was diluted with LB to adjust the microbial count to 10⁵ CFU / mL (20 mL per starting group).

[0203] Then, for each microbial solution, three sponges were taken, each sponge absorbing 5 mL of microbial solution, and placed in a sterile petri dish, incubated at room temperature for 3, 7, or 24 hours (3 time points × 3 independent starting cultures = 9 samples in total). At the same time, 5 mL of each microbial solution was taken and placed in an open petri dish, incubated at room temperature for the same time point (3 time points × 3 independent starting cultures = 9 samples in total).

[0204] Starting group #2: Escherichia coli (E. coli) was cultured in LB suspension for 8 hours (shaking at 220 rpm).

[0205] Each starting culture was diluted with LB to adjust the microbial count to 10⁵ CFU / mL (10 mL of each starting culture was required).

[0206] Then, each microbial solution was inoculated onto a sponge, with 5 mL of microbial solution inoculated onto each sponge, and placed in a sterile petri dish for 17 hours at room temperature (3 samples in total, from 3 independent starting cultures). 5 mL of each microbial solution was placed in an open petri dish and incubated at room temperature for the corresponding time point (3 samples in total).

[0207] In addition, clean LB was inoculated onto 4 sponges and incubated at room temperature for 3, 7, 17, and 24 hours, respectively (1 sponge at each time point, 4 samples in total). Simultaneously, 5 mL of each LB solution was placed on an open plate and incubated at room temperature for the corresponding time point (4 samples in total).

[0208] Each sponge was squeezed using the lid of the petri dish to extract the sample, and the resulting solution was diluted 10-fold five times. The microbial solutions on the plates were also subjected to the same dilution process.

[0209] Following Scheme 1, each dilution was inoculated into LB agar plates at a volume of 10 µL, and repeated inoculations were performed. The plates were incubated at 37°C for 18–24 hours.

[0210] The control sponge (soaked only in sterile LB medium) and the LB medium on the plates were not diluted before inoculation.

[0211] Colonies were counted, and total colony-forming units (CFU) were determined.

[0212] The experiment was conducted using three independent initial cultures.

[0213] Measurements included: initial colony-forming unit (CFU) counts for each microbial solution (before sponge addition) – 6 samples.

[0214] CFU counts for each solution extracted from the sponge, and CFU counts for the original bacterial solution at the corresponding time points.

[0215] Clean LB...The sterility of the culture medium was confirmed. Instructions for use, pages 22 / 24, CN 121079058 A

[0216] Results: The results showed that bacteria were clearly detected in melamine sponges regardless of the degree of contamination and in all repeated experiments (although the bacterial count was slightly low). In polyethylene acrylate sponges, the results were less clear, and not all experiments clearly showed the presence of bacterial contamination.

[0217] Figure 24A shows the bacterial culture on melamine sponges, and Figure 24B shows the bacterial culture on polyethylene acrylate sponges, with bacterial counts of 500 per milliliter (see section 2401) and 1000 per milliliter (see section 2402), respectively, according to some embodiments. For example, the initial culture of *E. coli* was cultured overnight in LB broth (oscillation rate 220 rpm), and then the initial culture was diluted in LB broth to adjust the microbial count to 10⁵ CFU / mL (colony forming units) (20 mL). Then, two sponges were inoculated with 5 mL of microbial solution and incubated on sterile plates at room temperature for 3, 7, or 24 hours. The CFU (colony-forming units) count of the bacteria was then measured. At all test time points (3, 7, 17, and 24 hours), there was no significant difference in the CFU count of the bacteria inoculated in the sponges compared to the corresponding bacterial solutions in the plates, indicating that the sponges had no effect on the viability or proliferation of the test bacteria compared to untreated bacteria.

[0218] Figure 25 is a graph and table showing the CFU counts of all starting bacterial solutions in melamine sponges and standard culture dishes at different time points according to some embodiments. The graphs were generated based on data from adjacent tables. As shown in Figure 25, at all test time points (3, 7, 17, and 24 hours), there was no significant difference in the CFU count of the bacteria inoculated in the sponges compared to the corresponding bacterial solutions in the culture dishes. This indicates that the sponges had no effect on the viability or proliferation of the tested bacteria compared to untreated bacteria.

[0219] The raw experimental data are listed in Tables 3A, 3B, 4A, and 4B.

[0220] It is anticipated that many related system building technologies, artificial intelligence methods, computer user interfaces, and image capturing devices will be developed during the effective period of the patents derived from this application, and the terminology of design elements, analysis procedures, and user devices is intended to cover all such new technologies in advance.

[0221] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although similar or equivalent methods and materials to those described herein may be used in carrying out or testing embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. Furthermore, the materials, methods, and examples described are for illustrative purposes only and do not constitute legal advice.This is intended to constitute any necessary limitation.

[0222] The terms “solar energy” and “sun” as used herein are used interchangeably.

[0223] The terms “about” or “approximately” as used herein mean ±10%. The terms “comprising,” “including,” “containing,” “having,” and their variations all mean “including but not limited to.”

[0224] The term “composed of” means “including and limited to.”

[0225] The term “consistently composed of” means that the composition, method, or structure may contain additional ingredients, steps, and / or components, provided that such additional ingredients, steps, and / or components do not materially alter the essential and novel features of the claimed composition, method, or structure.

[0226] The singular forms “an,” “a,” and “the” as used herein include plural references unless the context clearly specifies otherwise.

[0227] The term “voiding” as used herein refers to each urination and the daily volume of urine.

[0228] In this application, various embodiments of the invention may be described in the form of numerical ranges. It should be understood that the description in the form of a range is for convenience and brevity only and should not be construed as a strict limitation on the scope of the invention. Therefore, for a description of a range, it should be considered that the range description has specifically disclosed all possible subranges and the single numerical value within that range. For example, it should be considered that a range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and the single digit within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range.

[0229] Whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to. The phrases "range between the first indicator number and the second indicator number" and "range from the first indicator number to the second indicator number" used herein are interchangeable and refer to including the first and second indicator numbers, and all fractions and integers between them.

[0230] It is understood that certain features of the present invention, described in separate embodiments for clarity, may also be provided in combinations of a single embodiment. Conversely, various features described in a single embodiment for brevity may also be provided separately, in any suitable sub-combination, or in any other embodiment applicable to the present invention. Specific features described in the text of various embodiments are not considered essential features of those embodiments unless the embodiment would not function without those elements.

[0231] While the present invention has been described in conjunction with specific embodiments thereof, it will be apparent that many alternatives, modifications, and variations will apply.This will be apparent to those skilled in the art. Therefore, it is intended to include all substitutions, modifications, and variations falling within the scope of the appended claims.

[0232] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety. This is to the extent that each individual publication, patent, or patent application is specifically and individually indicated and incorporated herein by reference. Furthermore, any references cited or indicated should not be construed as an admission that such references are prior art to the present invention. The headings in this application are used herein to facilitate understanding of the specification and should not be construed as necessary limitations. Instruction manual page 24 / 24, page 27, CN 121079058 A, Figure 1; Instruction manual figure 1 / 28, page 28, CN 121079058 A, Figure 2A; Instruction manual figure 2 / 28, page 29, CN 121079058 A, Figure 2B; Instruction manual figure 3 / 28, page 30, CN 121079058 A; Instruction manual figure 4 / 28, page 31, CN 121079058 A; Instruction manual figure 5 / 28, page 32, CN 121079058 A; Instruction manual figure 6 / 28, page 33, CN 121079058 A, Figure 7; Instruction manual figure 7 / 28, page 34, CN 121079058 A, Figure 8; Instruction manual figure 8 / 28, page 35, CN 121079058 A; Instruction manual figure 9 / 28, page 36, CN 121079058 A; Instruction manual figure 10 / 28, page 37, CN 121079058 A Instruction Manual Illustrations, Page 11 / 28, 38 CN; 121079058 A Instruction Manual Illustrations, Page 12 / 28, 39 CN; 121079058 A Instruction Manual Illustrations, Page 13 / 28, 40 CN; 121079058 A Instruction Manual Illustrations, Page 14 / 28, 41 CN; 121079058 A Instruction Manual Illustrations, Page 15 / 28, 42 CN; 121079058 A Figure 17A Instruction Manual Illustrations, Page 16 / 28, 43 CN; 121079058 A Instruction Manual Illustrations, Page 17 / 28, 44 CN; 121079058 A Figure 18 Instruction Manual Illustrations, Page 18 / 28, 45 CN; 121079058 A Instruction Manual Illustrations, Page 19 / 28, 46 CN; 121079058 A Figure 20 Instruction Manual Illustrations, Page 20 / 28, 47 CN 121079058 A saidInstruction Manual Figures 21 / 28, Page 48, CN 121079058 A; Instruction Manual Figures 22 / 28, Page 49, CN 121079058 A; Instruction Manual Figures 23 / 28, Page 50, CN 121079058 A; Figure 25; Instruction Manual Figures 24 / 28, Page 51, CN 121079058 A; Table 3A: Raw CFU Count Data - Control Group (Stock); Instruction Manual Figures 25 / 28, Page 52, CN 121079058 A; Table 3B: Raw CFU Count Data - After Sponge Treatment; Instruction Manual Figures 26 / 28, Page 53, CN 121079058 A; Table 4A: Raw Colony Count Data - After Sponge Treatment; Instruction Manual Figures 27 / 28, Page 54, CN 121079058 A; Table 4B: Raw Colony Count Data - After Sponge Treatment; Instruction Manual Figures 28 / 28, Page 55, CN 121079058 A

Claims

1. A urine collection system, characterized in that Comprising: a sponge; and a housing configured to hold the sponge.

2. The system of claim 1, wherein, Further comprising a chemical test and / or a biological test.

3. The system of claim 1, wherein, Further comprising a sensor configured to alert a user when urination has begun.

4. The system of claim 1, wherein, Further comprising a sensor configured to alert a user when the sponge has absorbed a desired amount of urine.

5. The system of claim 4, wherein, The alert comprises an audible alert, a visual alert, or both.

6. The system of claim 1, wherein, The housing comprises an opening for facilitating the entry of urine.

7. The system of claim 1, wherein, The housing comprises an opening for expelling excess urine.

8. The system of claim 1, wherein, Further comprising a frame for securing the housing in place.

9. The system of claim 1, wherein, The sponge is a melamine sponge.

10. A method for collecting urine, characterized by Comprising: placing a urine collector comprising a housing and a sponge on a subject; adhering the housing to the subject and positioning the sponge over the subject's urethral opening; absorbing urine emitted by the subject with the sponge.

11. The method of claim 10, wherein, Further comprising inserting the sponge into the housing.

12. The method of claim 11, wherein, Further comprising deploying the plastic housing prior to the inserting.

13. The method of claim 10, wherein, Further comprising collecting urine from the sponge into a test meter.

14. The method of claim 13, wherein, The test meter is a biological test meter.

15. The method of claim 13, wherein, The test meter is integrated with the collector.

16. The method of claim 13, wherein, The test meter is external to the collector.

17. The method of claim 13, wherein, The test meter is a chemical test meter.

18. The method of claim 10, wherein, Further comprising securing the housing in place using a standard diaper.

19. A system for collecting a urine sample from a subject, comprising: Comprising: a housing configured to be secured to a user; an absorbent material configured to absorb a sample, at least partially surrounded by the housing; and an opening in the housing exposing the absorbent material to absorb urine from a subject.

20. The system of claim 19, wherein, The absorbent material comprises a sponge.

21. The system of claim 19, wherein, Further comprising a wick in contact with the absorbent material, the wick configured to draw urine from the absorbent material to an indicator.

22. The system of claim 21, wherein, The indicator is configured to indicate a chemical property of the urine.

23. The system of claim 21, wherein, The wick is at least partially surrounded by a tube.

24. The system of claim 21, wherein, The wick comprises a quantity indicator configured to indicate when the absorbent material has collected enough urine for analysis.

25. The system of claim 19, wherein, Further comprising: a cover between the patient and the absorbent material.

26. The system of claim 25, wherein, The cover is configured to prevent a first stream of urine from reaching the absorbent material.

27. The system of claim 26, wherein, The cover is burst open by the first stream of urine.

28. The system of claim 26, wherein, The cover absorbs the first stream of urine.

29. The system of claim 19, wherein, The housing is flexible.

30. The system of claim 19, wherein, The housing is provided with an adhesive at the edge of the opening.

31. The system of claim 30, wherein, The edge of the opening includes an adhesive-free region configured to facilitate the flow of excess urine from the absorbent material.

32. The system of claim 19, wherein, Further comprising an absorbent cover covering the opening.

33. The system of claim 32, wherein, The absorbent cover is hydrophilic.

34. The system of claim 32, wherein, The absorbent cover is hydrophobic and water-impermeable.

35. The system of claim 32, wherein, The absorbent cover is hydrophobic and water-permeable.

36. The system of claim 24, wherein, The analysis is a chemical analysis.

37. The system of claim 24, wherein, The analysis is a chemical biological test.

38. The system of claim 19, wherein, Further comprising a diaper for wrapping the system.

39. The system of claim 21, wherein, The indicator is selected from the group of: indantrione, fluorescein isothiocyanate (FITC), azo dye, color-changing ink, universal pH indicator, or a combination thereof.

40. A system for extracting urine from a sampler, comprising: Comprising: a sampler holder configured to support a sampler; an extractor configured to release urine from the sampler.

41. The system of claim 40, wherein, The sampler holder comprises a receptacle configured to fit the sampler.

42. The system of claim 40, wherein, The extractor comprises a push rod configured to squeeze the sampler when the sampler is held in the sampler holder.

43. The system of claim 40, wherein, Further comprising: A tester for determining a property of urine.

44. The system of claim 43, wherein, The tester includes a sensor for reading an indicator.

45. The system of claim 44, wherein, The tester includes a processor for interpreting the sensor output.

46. The system of claim 43, wherein, The tester includes an indicator.

47. The system of claim 44, wherein, The sensor is configured to read the indicator on the sampler.

48. The system of claim 43, wherein, The tester is modular.

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