Stool sample collection device and method

Abstract

The biological specimen collection device comprises a container and a lid that houses a vertical specimen collection tool in an eccentric position. In one embodiment, the device specifically collects a homogenized stool sample by a rotating mechanism that mixes the specimen and holds a preset amount on the specimen collection tool.

Description

[Technical Field]

[0001] The present invention relates to a field of stool sample collection apparatus and methods for collecting and analyzing stool samples.

[0002] Cross-references to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 544,210, “Stool Sample Collecting Device and Method Thereof,” filed on 15 October 2023, the contents of which are incorporated herein by reference. [Background technology]

[0003] Stool sample collection is extremely important because it has the potential to diagnose a wide range of medical conditions and diseases. The composition and characteristics of stool provide useful insights into various aspects of health, including, for example, gastrointestinal disorders such as inflammatory bowel disease (IBD) (e.g., Crohn's disease, ulcerative colitis), irritable bowel syndrome (IBS), and infections caused by bacteria, viruses, parasites, or other pathogens; infection identification; monitoring of digestive health; assessment of nutritional status, including food allergies; colorectal cancer screening; evaluation of digestive enzymes; and monitoring and treatment of chronic diseases, as well as research.

[0004] The quantitative measurement of analytes in stool samples is gaining attention as an important aspect of medical diagnosis, particularly for gastrointestinal diseases. Biochemical markers such as calprotectin are useful in the diagnosis and monitoring of diseases such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), infections, and other gastrointestinal disorders. Accurate measurement of calprotectin levels in stool samples can provide useful insights into inflammatory processes and support the differential diagnosis and management of these diseases.

[0005] Current diagnostic practices often require patients to collect stool samples at home and transport them to a medical facility for testing, which is inconvenient, uncomfortable, and can lead to a lack of compliance. For example, home testing for fecal calprotectin (FC) still requires user handling of the stool. Users must manually collect stool at at least three different locations using a collection stick to ensure homogeneous sampling. Furthermore, users may struggle to collect accurate or uniform quantities. Over-sampling or under-sampling can lead to inaccurate test results and affect the reliability of the diagnosis. Home stool sample collection devices that can collect pre-set small amounts of stool, accommodating both transport to a medical facility or home testing, could offer a promising solution. However, for such devices to be effective, accurate collection and homogenization of the stool sample are necessary to provide reliable quantitative analyte measurements.

[0006] Collecting stool samples at home for testing presents unique challenges, including variations in stool consistency and the need to minimize direct human contact with the samples. The collection device must be able to handle various stool consistencyes, from liquid to semi-solid to solid, and must ensure sufficient mixing of the samples to avoid inconsistencies in the concentration of the analyte. Furthermore, the device must enable accurate retention of the stool sample in the collection device, which is crucial for consistent and accurate analytical results.

[0007] The need for home-use sampling devices with such precision is increasing due to advancements in personalized medicine and the growing demand for convenient diagnostic solutions. These devices can enable patients to manage their own health more effectively, reduce the burden on healthcare facilities, and improve the overall accuracy and efficiency of digestive system diagnosis and monitoring. [Overview of the Initiative]

[0008] The object of the present invention is to disclose a stool collection device for collecting a predetermined amount of homogenized stool sample, the device comprising a stool receiving container configured to be placed on a toilet bowl, and a lid for sealing the container after stool has been collected in the container, the lid housing a vertical sample collection device extending from an opening in the lid and positioned eccentrically from the center of the lid, the sample collection device including a distal sample collection segment facing the container when sealed, the container being sealed by rotating the lid, thereby mixing and breaking down the stool by the rotating sample collection device, and as a result being able to hold the sample on the sample collection segment.

[0009] Another object of the present invention is to disclose a stool collection device disclosed herein, further comprising at least one homogenizing means extending from the inside of the lid, wherein by rotating the lid, the stool is mixed and broken down by the rotating homogenizing means and the sample collection device, thereby allowing the sample to be held on the sample collection segment.

[0010] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein by removing the sample collection device from the lid, excess stool sample is removed, leaving a preset amount of homogenized stool sample on the sample collection segment.

[0011] Another object of the present invention is to disclose a stool collection device disclosed herein, further comprising a sample collection cavity extending from an opening and housing a sample collection device.

[0012] Another object of the present invention is to disclose a fecal collection device disclosed herein, wherein at least one homogenizing means is selected from the group consisting of mixer elements, scrapers, impellers, propellers, rotors, agitators, mixers, paddles, spinners, blades, turbines, augers, spring-loaded mechanisms, and any combination thereof.

[0013] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein at least one homogenizing means includes a mixer element that rotates around the center of the container and around its own axis.

[0014] Another object of the present invention is to disclose a stool collection device as disclosed herein, wherein at least one homogenizing means comprises a paddle-shaped or frame-shaped mixer element.

[0015] Another object of the present invention is to disclose a fecal collection device disclosed herein, further comprising at least one fixing projection protruding from the inside of the container, the fixing projection being configured to prevent the feces from rolling, clumping, or sticking to the walls or bottom of the container.

[0016] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein at least one fixed projection is selected from a central projection extending upward from the central bottom surface of the container, a floor projection positioned along the bottom surface, and a wall projection extending radially inward.

[0017] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the sealing between the container and the lid is achieved by a central sealing mechanism.

[0018] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the sealing between the container and the lid is achieved by a peripheral sealing mechanism.

[0019] Another object of the present invention is to disclose a fecal collection device disclosed herein, wherein the central sealing mechanism includes an engagement between a hollow projection extending downward from the lid and a central projection or central threaded pin extending from the central portion of the container.

[0020] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the central sealing mechanism includes raising of a central threaded pin, thereby enabling the sample collection device to rotate at a minimum height from the bottom of the container from the start of rotation.

[0021] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the lid further comprises at least one chamber for securing a tube configured to accommodate a specimen sampling tool.

[0022] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the opening further comprises means for securing the specimen sampling tool within the opening.

[0023] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the specimen sampling tool cavity has dimensions that closely correspond to the specimen sampling tool, and is configured to enable removal of excess specimen volume retained on the specimen sampling tool 500 when the specimen sampling tool is detached from the lid.

[0024] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the specimen sampling tool further comprises a gripping segment for inserting the specimen sampling tool into and / or removing the specimen sampling tool from the container.

[0025] Another object of the present invention is to disclose the stool sampling device disclosed herein, which further comprises a protective function configured to prevent stool from being retained on segments of the specimen sampling tool other than the specimen sampling segment.

[0026] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the protective function is selected from a cap segment temporarily attached to the distal end of the specimen sampling tool, and a cavity extension portion extending from the specimen sampling tool cavity.

[0027] Another object of the present invention is to disclose the stool sampling device disclosed herein, wherein the opening comprises the specimen sampling tool cavity and an additional cavity extension portion configured to prevent contact between the stool inside the container and any segment of the specimen sampling tool other than the specimen sampling segment.

[0028] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the cavity extension and / or the tip of the sample collection device has a chamfered edge to prevent the accumulation of excess sample below the sample collection device.

[0029] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the homogenization means is rotated by a rack and gear mechanism.

[0030] Another object of the present invention is to disclose a fecal collection device disclosed herein, further comprising a fixing element configured to fix a container in a toilet bowl.

[0031] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the fixing elements are selected from the group consisting of brackets and lateral strips including adhesive.

[0032] Another object of the present invention is to disclose a stool collection apparatus disclosed herein in which a collected stool sample is used for the quantitative measurement of an analyte.

[0033] Another object of the present invention is to disclose a stool collection device disclosed herein in which the quantitative analyte indicates a disease, disorder, health condition, or any combination thereof in the subject being investigated.

[0034] Another object of the present invention is to disclose a stool collection device disclosed herein in which the quantitative analyte is nucleic acid or protein.

[0035] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein the sample collection segment comprises at least one groove.

[0036] Another object of the present invention is to disclose a stool collection device disclosed herein, wherein at least one groove is located on the side of the specimen collection device facing the direction of rotation.

[0037] Another object of the present invention is to disclose a method for collecting a predetermined amount of homogenized stool sample, the method comprising: (a) providing a stool collection device, the stool collection device comprising a stool receiving container configured to be placed on a toilet bowl, and a lid for sealing the container after stool has been obtained in the container, wherein the lid houses a longitudinal sample collection device extending from an opening in the lid and positioned eccentrically from the center of the lid, the sample collection device including a distal sample collection segment facing the container when sealed, the sealing of the container being performed by rotating the lid, thereby enabling the stool to be mixed and broken down by the rotating sample collection device and to be held on the sample collection segment; (b) fixing the container in a toilet bowl; (c) placing stool into the container; (d) sealing the container with the lid; and (e) removing the sample collection device from the lid, thereby collecting a predetermined amount of homogenized stool sample on the sample collection segment.

[0038] Another object of the present invention is to disclose a method disclosed herein in which the container in step (b) is secured using a bracket or a transverse strip.

[0039] Another object of the present invention is to disclose a method disclosed herein in which the sealing of the container in step (d) is performed by rotating the lid until it can no longer be rotated and / or until sensory feedback is obtained.

[0040] Another object of the present invention is to disclose a method disclosed herein in which the lid is rotated at least two times.

[0041] Another objective of the present invention is that the preset amount is 2 to 20 mm 3 To disclose a method disclosed herein that corresponds to the volume of [a certain substance].

[0042] Another object of the present invention is to disclose a method disclosed herein, further comprising the step of inserting a removed sample collection device into a tube containing a predetermined amount of diluent. [Brief explanation of the drawing]

[0043] Exemplary embodiments are shown in the referenced drawings. The embodiments and drawings disclosed herein are intended to be understood as illustrative, not limiting. However, the configuration and operation of the disclosure, as well as its purposes, features and advantages, will be best understood by reading the following detailed description together with the accompanying drawings. [Figure 1] Figures 1A to 1C are perspective views of a stool collection device 100 placed on a toilet bowl 50, having a bracket 200, a stool receiving container 300, a lid 400, and a vertical sample collection tool 500, according to some embodiments of the present invention. Figure 1D is a perspective view of the stool collection device 100, showing the stool receiving container 300, the lid 400, the vertical sample collection tool 500, and a transverse strip 211 having an adhesive 212. [Figure 2] Figure 2 is a cross-sectional view of the stool collection device 100, showing its internal structure and components, including the central fixing projection 312, the homogenization means 420, the sample collection device cavity 422, and the sample collection device 500 removed from the opening 410 of the lid 400. [Figure 3] Figures 3A to 3C are perspective views of the stool receiving container. Figure 3D is a perspective view of the central threaded pin 313 and fastener 314. Figure 3E is an exploded view of the container including the central threaded pin and fastener. [Figure 4] Figure 4A is a perspective view of the lid 400 having a handle 411, a sample collection cavity 422, homogenization means 420, and a sample collection device 500. Figure 4B is a bottom view of the lid 400, showing the sample collection cavity 422 and the homogenization means 420. Figure 4C is a bottom perspective view of the lid 400, showing the hollow projection 424 and the multiple homogenization means 420. [Figure 5]Figure 5A is a top perspective view of the lid of the sampling device, showing components such as the lid, handle, sample collection cavity, hollow projection, and gripping segment. Figures 5B and 5C are bottom perspective views of the lid, showing elements including the mixer element, sample collection cavity, gear mechanism, and hollow projection. [Figure 6] Figures 6A and 6B are perspective views of the sample collection device. Figure 6C is a cross-sectional view of the sample collection device incorporated into the lid. [Figure 7] Figure 7A shows front views of various embodiments of the longitudinal sample collection device 500. Figures 7B to 7D are enlarged perspective views of various configurations of the groove 535 and tip 532. [Figure 8] Figure 8A is a perspective side view of the longitudinal sample collection device 500, showing in detail the gripping segment 510, the longitudinal segment 520, the sample collection segment 530 with groove 535, and the locking element 511. Figure 8B shows an alternative configuration of groove 535. Figure 8C is a side view showing the sample collection segment 530 of the longitudinal sample collection device 500 within the cavity extension 423, showing groove 535. Figures 8D to 8G show examples of various cap segments. [Figure 9] Figure 9A is a cross-sectional view of a stool collection device according to several embodiments of the present invention, showing the internal components within the container. Figure 9B is a perspective view of the stool collection device, showing the arrangement of the container and lid as seen from above. Figures 9C and 9D are side views of the stool collection device, showing the arrangement of the sample collection tool and the protrusions within the container. [Figure 10] Figure 10 is a perspective cross-sectional view of the stool collection device, highlighting the central screw pin mechanism and internal protrusions. [Figure 11] Figure 11 is an assembled perspective view of the stool collection device, showing the internal gears and mixer elements within the container. [Figure 12] Figure 12 includes images of sample collection devices with different groove designs after operating the device with various sample characteristics. [Modes for carrying out the invention]

[0044] This invention discloses a device designed for stool sampling, which, in certain embodiments, has potential applications in a home environment. One of the major challenges in the quantitative analysis of stool analytes is the need to accurately measure the concentration of the analyte in a pre-set volume of homogeneously mixed stool sample. Since the state of stool varies widely from completely liquid to highly solid, and the volume of stool is unpredictable, there is a need for a device that can address these variability challenges. Specifically, the device must be able to homogenize the stool and ensure that the correct volume is held in the sample collection device. Furthermore, given that stool is a biological substance, it is essential that the device minimizes human contact and viewing of the sample to ensure patient compliance during the collection procedure. Designing a device that minimizes direct contact or viewing of the sample while enabling the collection of a pre-set volume of homogenized sample is a major challenge.

[0045] According to one aspect of the present invention, a stool collection device 100 is provided, comprising (i) a stool receiving container 300 and (ii) a lid 400 for sealing the container 300 and housing a vertical sample collection tool 500 inside the container 300.

[0046] In this specification, the terms “fecal receptacle” and “container” are used interchangeably.

[0047] In this specification, the terms "vertical specimen collection device" and "specimen collection device" are used interchangeably.

[0048] The apparatus described in the present invention is designed to be placed on a toilet bowl to collect stool from a subject. Referring here to Figures 1A to 1D, a stool collection apparatus 100 according to several embodiments of the present invention is shown. The apparatus 100 comprises a stool receiving container 300 and a lid 400 configured to seal the container 300 after the stool has been collected. The lid 400 houses a longitudinal sample collection device 500 that extends from an opening 410 of the lid 400 and is positioned eccentrically from the center of the lid 400. The longitudinal sample collection device 500 comprises a distal sample collection segment 530. In some embodiments, the sample collection device 500 extends through the opening 410, so that the sample collection segment 530 faces the container 300 when the container is sealed with the lid.

[0049] In this specification, the term "sealed" refers to the act of closing a container with a lid by rotating the lid. "Sealed" does not necessarily mean airtight or a complete seal.

[0050] In some embodiments, the container 300 is sealed by rotating the lid 400, which allows the stool to be mixed and broken down by the rotating sample collection device 500 and to be held on the sample collection segment 530.

[0051] In the exemplary diagrams shown in Figures 1A to 1C, the device 100 is attached to the toilet bowl 50 using a bracket 200. In some embodiments, the bracket 200 includes at least one lateral and / or intermediate support configured to be positioned on the toilet. For example, the bracket 200 may include two lateral supports (Figure 1B), or it may be shaped like a circular shell surrounding a portion of the container 300 (Figure 1C). The bracket 200 and the container 300 may be held together by a pin-notch mechanism or by adhesive. Alternatively, as shown in Figure 1D, the container 300 may be attached to the toilet using two lateral strips 211 with adhesive 212 on the inside facing the toilet bowl, thereby ensuring secure attachment of the container 300 to the toilet seat and / or bowl. In some embodiments, it is possible to use a low-strength adhesive with a large contact area on the lateral strips. This design ensures that the strips stay firmly in place due to the large contact area, providing stability during attachment to the toilet seat and / or bowl. In some embodiments, a large surface area has been found to ensure reliable positioning during use, while allowing for easy removal of the strip after operation is complete. Non-limiting examples of adhesives include, but are not limited to, double-sided tapes, adhesives, epoxy resins, cyanoacrylates, cellophane tapes, adhesive putties, contact cements, pressure-sensitive adhesives, or any combination thereof.

[0052] Next, refer to Figure 2. The lid 400 is designed to have an eccentrically positioned opening 410 for accommodating the longitudinal sample collection device 500, and this opening extends to the sample collection device cavity 422.

[0053] In this specification, the term “opening” refers to a slit, hole, void, chamber, cavity, or any combination thereof.

[0054] In some embodiments, the sample collection device 500 has a cylindrical, tubular, columnar, circular, cylindrical, rod shape, or any combination thereof.

[0055] The specimen collection device 500 comprises an external gripping segment 510 for inserting the vertical specimen collection device into and / or removing it from the container 300, a vertical segment 520, and a specimen collection segment 530 in which the specimen is held.

[0056] Once a stool sample is collected in container 300, the subject places the lid 400, which has the sample collection device 500 pre-loaded into the sample collection device cavity 422, on top of container 300 and seals it.

[0057] In the embodiment shown in Figure 2, the sealing mechanism is centrally located between a fixed central projection 312 protruding upward from the inside of the container 300 and a hollow projection 424 extending downward from the lid 400. In some embodiments, the central projection 312 comprises a screw-type sealing structure, which refers to a threaded or bolted function. The screw-type sealing structures disclosed herein are configured to seal the lid 400 onto the container 300 by the screw-type sealing mechanism.

[0058] During the sealing process, for example, by rotating the lid 400, the homogenizing means 420 protruding from the inner part of the lid 400 rotates, agitating and homogenizing the stool.

[0059] In this specification, “homogenizing means” means a component or mechanism configured to stir, mix, or agitate a substance to obtain a uniform or homogeneous mixture. It will be understood that homogenizing means may be fixed in place or may be capable of varying degrees of movement.

[0060] In some embodiments, the homogenization means 420 is selected from the group consisting of impellers, propellers, rotors, agitators, mixers, paddles, spinners, blades, turbines, augers, spring-loaded mechanisms, or any combination thereof.

[0061] In some embodiments, it has been found that using a rotating mixer element is more efficient for homogenizing feces compared to a propeller. Their features promote more uniform breakdown of fecal matter, minimizing the occurrence of untreated lumps and areas of uneven texture often seen in propeller-based mixing systems. In some embodiments, the rotating mixer element is frame-shaped. In some embodiments, the frame is rectangular, trapezoidal, elliptical, cylindrical, or any combination thereof. In some embodiments, the frame is rectangular. In some embodiments, the mixer element is hollow. In some embodiments, the mixer element rotates around the center of the container and around its own axis. In some embodiments, the mixer element has sharp edges facing the direction of rotation to promote fecal breakdown.

[0062] The container 300 may further include at least one fixing projection protruding from the inside of the container 300. In some embodiments, the at least one fixing projection prevents feces from sticking to the sides of the container and spreading along the sides.

[0063] Simultaneously, as the lid 400 rotates, the sample collection device 500, positioned within the sample collection device cavity 422, also rotates around the container 300, ensuring that a sufficient amount of homogenized stool is held in the sample collection segment 530.

[0064] It will be understood that any of the fixed protrusions disclosed herein, including those protruding from the container and / or lid, may be used to assist in the homogenization of the stool. For example, a specimen collection cavity 422 protruding from the lid 400 may be designed to have a sharp edge to facilitate the decomposition of the stool as it rotates within the container 300.

[0065] The container 300 may also include fixing elements (e.g., pins 316) designed to secure the container within the bracket 200.

[0066] The device is designed so that by rotating the lid 400, an appropriate amount of homogenized stool is reliably held in the sample collection segment 530 by the end of the sealing process. Once this process is complete, the sample collection device 500 can be removed. Removal of the sample collection device also removes any excess stool from the sample collection segment 530, leaving a precise amount in the holding portion, thereby enabling accurate quantitative measurement of the analyte. Continuing to refer to Figure 2, in some embodiments, the sample collection device is attached to a cap segment 550 configured to prevent the sample from being held in areas other than the sample collection segment 530. The cap segment 550 may remain inside the container 300 after the sample collection device has been removed.

[0067] This structural design makes it possible to collect a precise amount of stool sample without requiring direct human contact, thereby making the stool collection device 100 easy to use and improving user compliance.

[0068] In some embodiments, the apparatus 100 of the present invention further comprises means for securing the sample collection device 500 within the opening 410. Non-limiting examples of the securing means include, but are not limited to, grip pads, chucks, clamps, screw holes, tapped holes, pin notch mechanisms, or any combination thereof. In some embodiments, the securing means are configured to hold the sample collection device in place so as to prevent the sample collection device 500 from moving around its axis while the container is rotating and / or so as to ensure that the sample collection segment faces the stool during rotation.

[0069] Figures 3A and 3B show a fecal receiving container 300 according to several embodiments of the present invention. The container 300 is formed by a bottom surface 301 and a container wall 302 extending upward from the bottom surface 301. In the exemplary container shown in Figure 3A, the top of the container 300 is characterized by having a threaded opening 305, which is configured to engage with a corresponding threaded lid (not shown) for a secure seal.

[0070] In some embodiments, a screw-type sealing structure is configured to seal the lid 400 on the container 300. In some embodiments, the upper segment of the container is provided with a screw-type sealing structure. In some embodiments, the screw-type sealing is a peripheral screw-type sealing. In some embodiments, a central projection 312 is provided with a screw-type sealing structure. In some embodiments, the screw-type sealing is a central screw-type sealing. In this specification, the term “screw-type sealing” refers to a method of securely closing the container with a lid.

[0071] Comparing peripheral threads located on the periphery of a cylindrical component with central threads located in the center, central threads are likely preferable because they are less exposed to external loads and stresses. This minimizes the possibility of thread misalignment or seizure due to the coupling action. Furthermore, centralizing the threads allows for more uniform pressure distribution, resulting in even greater reliability compared to peripheral threads.

[0072] The interior of the container 300 is designed with various protrusions to assist in the homogenization of the stool. A central protrusion 312 is located in the center of the bottom surface 301 and extends upward. Around the central protrusion 312, upward-facing central protrusions 322 are provided to further break down the stool and prevent it from clumping together. Additional floor protrusions 324 extend laterally from the base of the central protrusion 312 and from the bottom surface 301, contributing to the mixing mechanism. The container wall 302 is also characterized by having a number of wall protrusions 320 extending radially inward, providing additional interaction points to assist in the thorough mixing of the stool. Furthermore, additional wall protrusions may be made to extend radially outward from the central protrusion 312. The bottom of the container 300 may include absorbent material 350 and / or structures, which may optionally be embedded in or integrated with the protrusions.

[0073] The absorbent body 350 may be positioned above the bottom surface 301 with a gap. This absorbent body may contain small holes that function like a sieve, thereby facilitating liquid movement and removing excess fluid. By incorporating these various protrusions and absorbent elements, the fecal receiving container 300 is designed to ensure effective mixing, prevent fecal clumping, and absorb unwanted liquid residue.

[0074] In some embodiments, the upper part of the container is characterized by having a diameter larger than the diameter of the bottom surface 301. In some embodiments, the upper part of the container further comprises a pin 316 configured to engage with at least one groove of the bracket 200. In some embodiments, the pin is configured to couple with at least one groove of the bracket 200. The pin 316 may be configured to secure the container 300 within the bracket 200 by a pin notch mechanism.

[0075] In some embodiments, at least one fixed projection protrudes upward from the floor, laterally from the wall, or laterally from the central projection at an angle of at least 0°, at least 10°, or at least 15° (including any range or value between these). In some embodiments, at least one fixed projection protrudes from the floor at an angle of 0° to 90°, 80° to 90°, 70° to 90°, 0° to 75°, 0° to 50°, or 0° to 25° (including any value between these).

[0076] In some embodiments, at least one fixing projection (e.g., 312, 320, 322, 324) protruding from the inside of the container prevents the stool from being dragged along.

[0077] In some embodiments, the central projection 312 is located in the center of the container. In some embodiments, at least one fixing projection is configured to prevent the stool from forming clumps, bundles, lumps, groups, or aggregates. In some embodiments, the central projection 312 is configured to move the stool from the center of the container to the sides of the container. In some embodiments, the central projection 312 is configured to move the stool from the center of the container to the sample collection device 500.

[0078] In some embodiments, at least one fixed projection 324 is continuous. In some embodiments, at least one fixed projection 324 is discontinuous. In some embodiments, at least one fixed projection 324 connects the central projection 312 and at least one wall projection 320.

[0079] In some embodiments, the container 300 further comprises an absorbent 350 configured to absorb liquids. Non-limiting examples of such absorbents include sponges, membranes, paper, silica gel, zeolites, or any combination thereof. In this specification, the term “liquid specimen” refers to water and urine present in watery or diarrheal stools.

[0080] In some embodiments, the absorbent may be used to concentrate the sample and improve the efficiency of homogenization.

[0081] In some embodiments, the absorbent 350 is located at the inner bottom of the container 300. The absorbent 350 may extend from the bottom surface 301 of the container to the wall 302. In some embodiments, the absorbent 350 is a physical absorbent. In this specification, the term “physical absorbent” refers to a filter located at the bottom of the container. In some embodiments, there is a gap between the filter and the bottom surface of the container configured to contain the filtered liquid sample. In some embodiments, the filter is made of metal, ceramic, composite material, polymer, or any combination thereof.

[0082] Figure 3C shows a stool collection container 300 according to several embodiments of the present invention. In some embodiments, as shown in Figures 3D and 3E, a separate central threaded pin 313 connected to the central portion of the bottom surface 301 by, for example, a fastener 314 has been found to be beneficial for collecting stool samples from relatively small amounts of stool. By using such a separate threaded mechanism, the sample collection segment 530 can be positioned at the minimum height from the bottom surface when the container 300 is closed with the lid 400. When the container 300 is sealed, the central threaded pin 313 rises, allowing the sample collection device to rotate while maintaining the sample collection segment 530 at the minimum height from the bottom surface 301 from the start of rotation, eliminating the need to lower the sample collection segment 530 during rotation. In some embodiments, the fastener disclosed herein may be a screw or a bolt.

[0083] The container wall 302 is supplemented by lateral connectors 360 located on both sides of the container wall, which connect to the container via lateral strips 211 and can help secure the container in the toilet bowl during use. Floor projections 324 are arranged around the central threaded pin 313 and can extend upward from the bottom surface 301. These projections 324 are designed to prevent the stool from clumping and can help agitate the sample to ensure uniform consistency.

[0084] Continuing to refer to Figure 3C, a rack 303 may be integrally provided within the stool receiving container 300 along the periphery of the container wall 302. This rack 303 may function as part of a rack gear mechanism designed to rotate a rotating homogenizing means 420, such as an agitator.

[0085] In this specification, “rack gear mechanism” means a combination of a linear or linear gear known as a rack and an engaging circular gear known as a pinion, in which the linear motion of the rack is converted into the rotational motion of the pinion, and vice versa. A rack typically comprises a series of teeth arranged at equal intervals along the length of a substantially elongated linear body. A pinion is a circular gear with teeth designed to mesh with the teeth of the rack, enabling it to engage with the rack and convert linear motion into rotational motion.

[0086] In applications relating to homogenization means, a rack gear mechanism is used to rotate the homogenization means by converting a linear force applied to the rack into a rotational force acting on a pinion. This rotational force is then transmitted to the homogenization means. For example, in a homogenization apparatus for biological materials, a linearly moving rack may engage with a pinion connected to a rotating mixing blade or element. As the rack moves linearly along the top of the container wall, the pinion rotates, thereby driving the rotation of the mixing element and resulting in a homogeneous mixture of the biological material.

[0087] In some embodiments, the container 300 is disposable. In some embodiments, the container is biodegradable. In some embodiments, the container is rigid. In some embodiments, the container 300 is made of a composite material, ceramic, polymer, or any combination thereof.

[0088] Figures 4A to 4C show detailed illustrations of the lid 400 of a stool sample collection device according to several embodiments of the present invention, along with its various integral components. The lid 400 is designed to securely seal the stool receiving container 300 and to facilitate the homogenization of the stool during the sealing process. The lid 400 is characterized by having a handle 411, which facilitates handling and operation of the lid. Furthermore, the lid 400 includes homogenization means 420 that project downward from the lid into the container 300. The homogenization means 420 is designed to engage with the stool when the lid 400 is closed, ensuring sufficient mixing and homogenization for accurate sampling. The lid 400 also includes a sample collection device cavity 422 located at an eccentric position, which is specifically designed to accommodate a longitudinal sample collection device 500, used to collect an accurately measured stool sample.

[0089] In some embodiments, the lid 400 further comprises at least one homogenizing means 420 configured to agitate the stool in the container. In some embodiments, at least one homogenizing means 420 is configured to guide the agitated stool to the sample collection segment 530. In some embodiments, at least one homogenizing means 420 is a flat paddle, cross paddle, propeller paddle, anchor paddle, turbine paddle, ribbon paddle, baffled paddle, double helix paddle, or any combination thereof. In some embodiments, at least one homogenizing means 420 has a customized paddle shape based on the required agitation.

[0090] Furthermore, the lid 400 may have a hollow projection 424 configured to engage with a central fixing projection 312 or a central threaded pin 313 during the sealing process. Engagement with the central threaded pin 313 allows both the central threaded mechanism and the sample collection device 500 to rotate, ensuring that the sample collection segment 530 remains at a minimum height from the bottom surface from the start of the sealing process.

[0091] Referring here to Figures 5A to 5C, the lid 400 and its internal operating components according to several embodiments of the present invention are shown. The lateral support element 211 is connected to the container 300 via a lateral connector 360 and is designed to be attached to the external toilet base. The lateral connector 360 preferably has a crescent shape to facilitate the lateral extension of the support element 211. The handle 412 facilitates the user to rotate the lid 400 during sealing. Also shown is a hollow projection 424 that interacts with a central threaded pin 313 during the sealing process.

[0092] The homogenization component may include a scraper 421 designed to remove sample residue adhering to the container wall 302 and a mixer element 426. The mixer element 426 may be connected to a gear mechanism that enables its rotation via a rack gear system. In some embodiments, the gear mechanism comprises one or more gears. In some embodiments, the gear mechanism comprises a large gear 430 and a small gear 431. In some embodiments, the large gear 430 and the small gear 431 operate in tandem to transmit motion for driving the mixer element 426. The mixer element may also be provided with at least one sharp edge to facilitate the disintegration of the sample.

[0093] The sample collection device cavity 422 may be elongated and have an additional cavity extension 423 that includes an opening to allow interaction between the sample collection segment 530 and the stool sample. The cavity extension 423 may be designed to have a chamfered edge to prevent sample accumulation below the sample collection device 500. It will also be understood that the sample collection device cavity 422 and the cavity extension 423 may be integral parts of a single continuous component.

[0094] Referring to Figures 6A to 6C, the specimen collection device 500 and its assembly into the lid 400 are shown according to several embodiments of the present invention. The opening 410 of the lid 400 may further comprise means for securing the gripping segment 510 of the specimen collection device 500 within the opening 410. Non-limiting examples of the securing means include, but are not limited to, screw mechanisms, grip pads, chucks, clamps, pin-notch mechanisms, or any combination thereof. In some embodiments, the opening 410 further comprises a projection 545 or notch 540 configured to secure the specimen collection device 500 by a pin-notch mechanism.

[0095] In some embodiments, the dimensions of the opening 410 correspond to the dimensions of the sample collection device 500. In some embodiments, the opening 410 is circular. In some embodiments, the opening 410 is characterized by a diameter larger than the diameter of the longitudinal segment 520 of the sample collection device. In some embodiments, the opening 410 is characterized by a diameter larger than the diameter of the sample collection segment 530.

[0096] In some embodiments, the sample collection cavity 422 is located below the opening 410. In some embodiments, the opening 410 includes the sample collection cavity 422. In some embodiments, the sample collection cavity 422 is fixed to the side of the opening 410 facing the container. In some embodiments, the sample collection cavity 422 is positioned eccentrically from the center of the lid.

[0097] The sample collection cavity 422 disclosed herein is configured to house the sample collection device 500 and protect the sample collection device from mechanical and / or radial forces during agitation. In some embodiments, the sample collection cavity 422 is configured to agitate the stool within the container 300. In some embodiments, the sample collection cavity 422 is configured to remove excess stool from the sample collection segment 530 or other exposed components of the sample collection device when the sample collection device 500 is removed. In some embodiments, the dimensions of the cavity 422 correspond to the longitudinal segment 520 of the sample collection device, thereby allowing for the removal of excess stool sample during removal of the sample collection device. In some embodiments, the cavity side facing the container 300 is characterized by a conical shape. In some embodiments, the conical cavity is configured to remove excess stool during removal of the sample collection device 500.

[0098] In the example shown in Figure 6C, the length of the sample collection device 500 is longer than the sample collection device cavity 422. In some embodiments, the edge of the sample collection device cavity 422 facing the container is characterized by having an angle of at least 5°, at least 10°, or at least 15° (including any range or value between them) with respect to the cross-section of the cavity. In some embodiments, the edge of the sample collection device cavity 422 is characterized by having an angle of 5° to 60°, 5° to 50°, 5° to 40°, or 10° to 30° (including any range or value between them) with respect to the cross-section of the constructed cavity.

[0099] In some embodiments, the cavity dimensions are configured to separate the cap segment 550 from the sample collection segment 530 during the removal of the sample collection device 500 from the lid 400.

[0100] In some embodiments, both the sample collection tool gripping segment 510 and the longitudinal segment 520 are housed within the lid. In other embodiments, the longitudinal segment 520 is housed within the sample collection tool cavity 422.

[0101] During agitation, the sample collection device 500 rotates, and the stool sample is held in the sample collection segment 530. Figures 7A to 7D show various examples of grooves 535 in the sample collection segment 530.

[0102] The distal end of the longitudinal segment 520 transitions into the sample collection segment 530. The leading edge of the sample collection segment 530 is the tip 532. The sample collection segment 530 is provided with at least one groove 535, which are strategically positioned to capture the stool sample as the sample collection device 500 is rotated or moved within the container 300. The grooves 535 ensure that the collected sample is held securely within the sample collection segment 530 until the sample collection device 500 is withdrawn from the container 300. The grooves 535 can be modified in size and shape to accommodate various sample requirements and can be positioned at various heights and / or circumferentially around the sample collection segment 530.

[0103] In this specification, the term “groove” means a notch, gap, cavity, recess, slot, or any combination thereof. In some embodiments, at least one groove 535 collects a stool sample when it comes into contact with stool.

[0104] In some embodiments, at least one groove 535 is located on the sample collection segment 530. In some embodiments, at least one groove 535 is located on the side of the sample that moves in conjunction with the sealing motion. In some embodiments, at least one groove 535 faces the stool when sealing the container. In some embodiments, at least one groove 535 faces the stool when stirring. In some embodiments, the groove 535 is located on the side of the sample collection device facing the direction of rotation, thereby achieving maximum retention.

[0105] FIGS. 8A to 8C show a specimen collection device 500 according to some embodiments of the present invention. The distal tip 532 of the specimen collection device 500 is designed to have a chamfered edge to minimize stool retention below the specimen collection device 500. The gripping segment 510 can include a locking element 511 for securing the specimen collection device within the tube 600 during insertion.

[0106] In some embodiments, as shown in FIGS. 8B and 8C, it has been found that a cross-shaped groove 535 with curved corners allows the interior of the groove to be completely filled, preventing the formation of regions within the groove 535 where no specimen is present. In other embodiments, it has been found that a lip angle of approximately 90° enables greater retention of the specimen compared to a sloped lip.

[0107] In some embodiments, the dimensions of the groove are configured to retain a specimen volume of 1 to 20 mm after the specimen collection device is removed from the cap 3 , 1 to 15 mm 3 , 2 to 15 mm 3 , 1 to 10 mm 3 , 1 to 8 mm 3 , 2 to 8 mm 3 , or 3 to 8 mm 3 , or any range therebetween. Each of these ranges represents a separate embodiment of the present invention.

[0108] In some embodiments, the dimensions of the groove are configured to retain a specimen volume of approximately 5 mm after the specimen collection device is removed from the cap 3 .

[0109] In the exemplary figure, only the side of the sample collection segment 530 is exposed, while the rest of the sample collection device is enclosed by the sample collection cavity 422 and the cavity extension 423. This configuration ensures that the sample is accurately retained on the sample collection segment 530 when the sample collection device 500 is removed. In some embodiments, the cavity extension 423 may be pocket-shaped to secure the sample collection device 500 in place. For example, the cavity extension may include a projection 425 that extends to the front side of the distal end of the sample collection device 500.

[0110] The design of these elements enables the vertical sample collection device 500 to operate efficiently with the stool collection device, ensuring accurate and hygienic sampling for further analysis.

[0111] Figures 8D–8G show illustrative diagrams of the cap segment 550. The cap segment may be temporarily attached to the distal end of the sample collection device and may include a plug 551 (Figures 8D and 8E) that blocks direct contact between the collection segment 530 and the stool at the distal end of the sample collection device. The shape of the cap segment may be an inverted cone, with the maximum diameter of the cone located at its distal outer portion facing the stool sample. In some embodiments, the maximum diameter of the cap segment 550 is larger than the inner diameter of the opening 410 and / or the sample collection device cavity 422. When the sample collection device is withdrawn from the device 100, the cap segment 550 is detached from the collection device 500 and may remain in the container 300. Excess stool present on the outer surface of the stick 200 remains attached to the inner portion of the cavity 422, thereby allowing sampling of a preset amount of stool. The cap segment 500 may also be a removable hollow cylinder 552 that temporarily covers the distal portion of the sample collection device 500 (Figures 8F and 8G). The cap segment may include an opening configured to allow direct contact between the groove 535 and the stool sample. Similar to the plug 551, the cap segment 552 may also be configured to detach from the sample collection device 500 when withdrawn from the device 100. The cap segment can be made of a flexible material. Non-limiting examples of such flexible materials include silicone elastomers, polyurethane elastomers, thermoplastic elastomers (TPEs), natural rubber, fluorosilicone rubber, and ethylene propylene diene monomer (EPDM) rubber.

[0112] Referring here to Figures 9A and 9B, apparatuses according to several embodiments of the present invention are shown. Figure 9A shows a lid 400 with a sample collection cavity 422 and an additional separate homogenization means 420. The homogenization means 420 has a flat paddle shape. In some embodiments, the homogenization means 420 is configured to agitate the stool in the container and guide the agitated stool to the sample collection segment 530.

[0113] Furthermore, the lid 400 may have at least one chamber on its upper side (Figure 9B). In some embodiments, at least one chamber is configured to secure the tube 600. In some embodiments, the lid 400 includes a chamber 450 configured to secure the tube 600 horizontally before use. The chamber 450 can also be used as a handle. In some embodiments, the lid includes a chamber 440 configured to secure the tube when inserting a sample collection device holding a stool sample. In some embodiments, the chamber 440 is a fixing projection that protrudes downward from the lid 400 into the container 300. In some embodiments, the chamber 450 is located within a downward-facing hollow projection. In this specification, the term “upper side” refers to the side opposite to the container 300. In some embodiments, the chamber 450 is located in the same plane as the opening 410. In some embodiments, the chamber 440 is located eccentrically from the center of the lid. In some embodiments, the chamber 440 is located at the center of the lid 400. In some embodiments, the chambers 450 and 440 are in the same plane. In some embodiments, the chamber 440 and the opening 410 are in the same plane. In some embodiments, the tube 600 is configured to house a stool sample collection device 500.

[0114] In some embodiments, the tube 600 contains a predetermined amount of diluent for diluting a predetermined amount of collected stool sample for further analysis.

[0115] Figures 9C and 9D further illustrate the apparatus, showing a container 300 sealed by a lid 400. The container may include pins 316 configured to secure the container on a bracket 200. The lid may further include a chamber 440 configured to secure a tube 600.

[0116] Figures 9C, 9D, and 10 show the apparatus 100 in a cross-sectional view, illustrating in detail its various components and their spatial relationships. The container 300 may be equipped with at least one fixed projection, e.g., a wall projection 320, a central projection (e.g., a threaded pin 313), and a floor projection 324 (Figure 9C), which are designed to prevent feces from adhering to the inner surface of the container and to facilitate the homogenization process. The container 300 may include a rack 303 (Figure 9D) configured to engage with the homogenization means 420 and to facilitate the rotation of the homogenization means 420 via a rack and gear mechanism.

[0117] As shown in Figure 9D, when the lid 400 is rotated, a hollow projection 424 extending downward from the lid interacts with a centrally threaded pin 313, causing the pin 313 to rise in the Z direction. This mechanism positions the sample collection segment 530 at the minimum distance from the bottom surface 301 of the container from the start of lid rotation, maximizing the contact time between the sample collection segment and the stool in the container. This feature is particularly important when the amount of stool collected in the container is small or low, ensuring effective contact and sample collection even with small sample volumes.

[0118] Figure 11 shows a detailed perspective view of the internal components of the stool sample collection device. At the center of the configuration is a central threaded pin 313. Multiple floor protrusions 324 are positioned at the bottom of the container, thereby preventing stool from adhering to the surface and assisting in the mixing process and homogenization of the sample. In some embodiments, as the lid 400 rotates, the sample collection device 500 passes between the floor protrusions 324. This positions the sample collection segment 530 at the minimum height above the bottom surface 301 during rotation, enabling homogenization even with very small or small sample volumes.

[0119] In the embodiment shown in Figure 11, the rack 303 is positioned along the upper inner circumference of the container 300. When the lid 400 is placed on top of the container 300 and rotated, the small gear 431 engages with the corresponding large gear 430, enabling rotational motion for various homogenization and sampling processes within the apparatus. Specifically, in some embodiments, a mixer element 426 protrudes downward from the large gear 430 and rotates accordingly. The mixer element 426 is hollow and rectangular and may also have sharp edges facing the direction of rotation to facilitate mixing and cutting of the stool. Other possible shapes of the mixer element include cylindrical, elliptical, or trapezoidal designs, each contributing characteristically to the efficiency of the mixing process.

[0120] In some embodiments, the presence of a central sealing mechanism makes it possible to incorporate a circumferential rack and gear mechanism to facilitate the rotation of the homogenizing means. While the present invention focuses on manual homogenization in which the user rotates the lid to operate the homogenizing means, it will be understood that automated means can also be employed to facilitate the rotation of the homogenizing means 420. An example of such automated means is an integrated electric motor coupled to the lid 400.

[0121] During rotation, the sample collection segment 530 collects a sufficient amount of stool sample, and any excess sample is removed when the sample collection device is withdrawn from the lid. In some embodiments, it has been found that at least two full 360-degree rotations are required to adequately hold the sample in the sample collection segment 530. In some embodiments, it has been found that at least 2.5, 3, 3.5, 4, 4.5, 5, 5.5, or 6 full 360-degree rotations are required to completely fill the groove 535 of the sample collection segment 530. In some embodiments, it has been found that in the collection device disclosed herein, it is possible to adequately hold the sample in the sample collection segment 530 with fewer than three rotations. In some embodiments, 1.5 to 3.5 rotations are required to adequately hold the sample in the sample collection segment 530.

[0122] Subsequently, the sample collection device 500 is inserted into the tube 600 and transported to another location for further analysis, or it may be stored for testing of the analyte in the sample.

[0123] In some embodiments, the insertion and removal of the sample collection device are performed manually, automatically, or a combination thereof.

[0124] In some embodiments, the apparatus 100 is made of metal, composite material, ceramic, polymer, or any combination thereof. In some embodiments, non-limiting examples of polymers include, but are not limited to, C1-C10 polyalkenes (e.g., polyethylene, polypropylene), polyurethane, polyvinyl chloride, nylon, polycarbonate, polyoxymethylene, polyethylene terephthalate, fluoropolymer, polyester (e.g., polyhydroxyalkanoate), polyglycolic acid, polycaprolactone, polylactic acid, polystyrene, cellulose, lignin, hemicellulose, starch (e.g., amylose, amylopectin), or any combination thereof. In some embodiments, the apparatus 100 or any part thereof is made of pulp paper, cardboard, or any combination thereof.

[0125] In this specification, the term "C1-C10 polyalkene" refers to a polymer derived from C1-C10 alkene monomers. In this specification, the term "C1-C10 alkene" refers to an alkene containing 2, 3, 4, 5, 6, 7, 8, 9, or 10 carbon atoms, such as ethylene, propylene, butylene, and isopropylene. In this specification, the term "alkene" refers to a hydrocarbon containing a double bond.

[0126] In some embodiments, the device is disposable. In some embodiments, the device is reusable. In some embodiments, the device or any part thereof is biodegradable. In this specification, the term “biodegradable” means a material, substance or product that, in the presence of microorganisms such as bacteria and fungi, decomposes over time into smaller substances such as water, organic matter, and carbon dioxide.

[0127] Those skilled in the art will understand that the apparatus 100 may include additional or fewer elements.

[0128] In some embodiments, the collected stool sample is intended for use in methods for measuring the level of analytes in a subject, methods for detecting analytes, methods for monitoring analytes, or any combination thereof.

[0129] In some embodiments, the analyte detected in the sample is a protein or nucleic acid whose quantitative level correlates with a disease or disorder. In some embodiments, the analyte is used for monitoring a disease or disorder.

[0130] In some embodiments, the analytes detected in a sample reflect the health status of the subject. In particular, the analytes may indicate the health status of the subject's digestive system or intestines (e.g., microbiome).

[0131] In some embodiments, the subject is a mammal. In some embodiments, the subject is a human.

[0132] In some embodiments, non-limiting examples of methods for measuring analyte levels include, but are not limited to, spectroscopy, chromatography, mass spectrometry, fluorescence measurement, luminescence measurement, electrophoresis, immunoassay, lateral flow assay, or any combination thereof.

[0133] Non-exclusive examples of methods for detecting stool analytes include, but are not limited to, chemical analyzers, polymerase chain reactions, lateral flow immunoassays, stool fat analysis setups, flow cytometers, mass spectrometers, microbiome sequencing devices, or any combination thereof.

[0134] In some embodiments, the analyte is a quantitative diagnostic marker for a disease or disorder. In some embodiments, a predetermined amount of stool is used for the quantitative measurement of the analyte disclosed herein.

[0135] In this specification, the term "analyte" includes proteins, nucleic acids, cells, or any combination thereof.

[0136] In some embodiments, the apparatus disclosed herein has been found to be usable for calprotectin measurement.

[0137] While this device is primarily designed for the quantitative measurement of analytes, it will be understood that it can also be used for non-quantitative analytes. In some embodiments, detection relates to medical conditions, medical diseases, microorganisms, or any combination thereof.

[0138] In some embodiments, the medical condition or medical disorder is selected from the group consisting of gastrointestinal disorders, irritable bowel syndrome, inflammatory bowel disease, infections, allergies, or cancer, and includes any combination thereof.

[0139] In some embodiments, the microorganism is selected from the group consisting of bacteria, viruses, fungi, parasites, archaea, or any combination thereof.

[0140] In another embodiment, a method is provided for collecting a predetermined amount of homogenized stool sample, the method being: (a) A step of providing a stool collection device, wherein the stool collection device comprises a stool receiving container 300 configured to be placed on a toilet bowl, and a lid 400 for sealing the container 300 after stool has been obtained in the container, the lid 400 housing a vertical sample collection tool 500 extending from an opening 410 of the lid 400 and positioned eccentrically from the center of the lid 400, the sample collection tool 500 including a distal sample collection segment 530 facing the container 300 when sealed, the sealing of the container 300 being performed by rotating the lid 400, thereby enabling the stool to be mixed and broken down by the rotating sample collection tool 500 and to be held on the sample collection segment 530, (b) The step of fixing the container 300 inside the toilet bowl, (c) The step of putting feces into container 300, (d) The step of sealing the container 300 with the lid 400, (e) The step of removing the sample collection device 500 from the lid 400, thereby collecting a predetermined amount of homogenized stool sample onto the sample collection segment 530.

[0141] In some embodiments, step (a) provides a stool collection device as disclosed herein, which further comprises at least one homogenizing means 420 extending from the inside of a lid 400, wherein the container 300 is sealed by rotating the lid 400, thereby allowing the stool to be mixed and broken down by the rotating homogenizing means 420 and the sample collection device 500, and to be held on the sample collection segment 530.

[0142] In some embodiments, sealing the container 300 in step (d) is performed by rotating the lid 400 until it can no longer be rotated and / or until sensory feedback is obtained.

[0143] In this specification, “sensory feedback” encompasses at least one auditory, visual, or tactile notification. Non-exclusive examples of auditory notifications include beeps, voice alerts, alarms, and melodic chimes. Examples of visual notifications include LED indicator lights, display screen messages, flashing lights, and icons. Tactile notifications provide physical feedback through touch. Non-exclusive examples may include clicks or snaps, vibration feedback, increased resistance, and tactile pulses.

[0144] In this specification, the term "approximately" when used with a numerical value refers to ±20% of the reference value.

[0145] Please understand that the terms "sample collection device," "sample collection stick," and "vertical sample collection device" are used interchangeably.

[0146] Example 1 The apparatus 100 disclosed herein was tested for its ability to collect preset amounts of samples having various properties ranging from liquid to solid, using a sample collection device 500 having various collection grooves 535. The results are shown in Figure 12 and Table 1.

[0147] TIFF2026536608000002.tif166128

[0148] The results showed that sticks #1 and #2 yielded the best results for stools with a more solid consistency, while sticks #1 and #4 performed best for stools with a more liquid consistency.

[0149] A groove facing directly towards the stool was more effective than one positioned to the side.

[0150] Wider grooves demonstrated superior performance compared to very narrow grooves or widely spaced grooves.

[0151] When the amount of stool was small, such as small stools or watery stools, the groove, which was positioned higher, was not completely filled. Therefore, to improve collection efficiency under such conditions, it is beneficial to position the groove lower.

[0152] Unexpectedly, the best results were obtained with stick #5, which features vertical grooves, and it performed well with both semi-solid and solid samples.

Claims

1. A stool collection device (100) for collecting a predetermined amount of homogenized stool sample, A feces receiving container (300) configured to be placed on the toilet bowl, The container is equipped with a lid (400) for sealing the container (300) after feces have been obtained inside the container. The lid (400) houses a vertical specimen collection device (500) that extends from the opening (410) of the lid (400) and is positioned eccentrically from the center of the lid (400). The specimen collection device (500) includes a distal specimen collection segment (530) that faces the container (300) when sealed, A stool collection device characterized in that the container (300) is sealed by rotating the lid (400), thereby the stool is mixed and broken down by the rotating sample collection device (500), and as a result, the sample can be held on the sample collection segment (530).

2. In the stool collection device according to claim 1, The lid (400) further comprises at least one homogenizing means (420) extending from the inside, A stool collection device characterized in that, by rotating the lid (400), the stool is mixed and broken down by the rotating homogenizing means (420) and the sample collection device (500), and as a result, the sample can be held on the sample collection segment (530).

3. In the stool collection device according to claim 1 or 2, A stool collection device characterized in that, by removing the sample collection device (500) from the lid (400), excess stool sample is removed, leaving a preset amount of homogenized stool sample on the sample collection segment (530).

4. In a stool collection device according to any one of claims 1 to 3, A stool collection device further comprising a specimen collection device cavity (422) extending from the opening (410) and housing the specimen collection device (500).

5. In the stool collection device according to claim 2, A stool collection device characterized in that the at least one homogenizing means (420) is selected from the group consisting of a mixer element (426), a scraper (421), an impeller, a propeller, a rotor, an agitator, a mixer, a paddle, a spinner, a blade, a turbine, an auger, a spring mechanism, and any combination thereof.

6. In the stool collection device according to claim 2, A stool collection device characterized in that the at least one homogenizing means (420) includes a mixer element (426) that rotates around the center of the container (300) and around its own axis.

7. In the stool collection device according to claim 2, A stool collection device characterized in that the at least one homogenizing means (420) includes a paddle-shaped or frame-shaped mixer element (426).

8. In a stool collection device according to any one of claims 1 to 7, A stool collection device further comprising at least one fixing projection protruding from the inside of the container (300), wherein the fixing projection is configured to prevent the stool from rolling, clumping together, or adhering to the walls or bottom of the container.

9. In the stool collection device according to claim 8, A stool collection device characterized in that the at least one fixing projection is selected from among a central projection (312) extending upward from the central bottom surface of the container, a floor projection (324) arranged along the bottom surface, and a wall projection (320) extending radially inward.

10. In a stool collection device according to any one of claims 1 to 9, A stool collection device characterized in that the sealing between the container (300) and the lid (400) is performed by a central sealing mechanism.

11. In a stool collection device according to any one of claims 1 to 9, A stool collection device characterized in that the sealing between the container (300) and the lid (400) is performed by a peripheral sealing mechanism.

12. In the stool collection device according to claim 10, A stool collection device characterized in that the central sealing mechanism includes an engagement between a hollow projection (424) extending downward from the lid (400) and a central projection (312) or a central threaded pin (313) extending from the central portion of the container (300).

13. In the stool collection device according to claim 12, A stool collection device characterized in that the central sealing mechanism includes raising the central threaded pin (313), thereby enabling the sample collection tool (500) to rotate at the minimum height from the bottom surface (301) of the container (300) from the start of rotation.

14. In a stool collection device according to any one of claims 1 to 13, A stool collection device characterized in that the lid (400) further comprises at least one chamber for fixing a tube (600) configured to house the specimen collection device (500).

15. In a stool collection device according to any one of claims 1 to 14, A stool collection device characterized in that the opening (410) further comprises means for fixing the specimen collection device (500) within the opening (410).

16. In the stool collection device according to claim 4, A stool collection device characterized in that the sample collection device cavity (422) has dimensions that precisely correspond to the sample collection device (500), and when the sample collection device is removed from the lid (400), it is possible to remove any excess sample held in the sample collection device (500).

17. In a stool collection device according to any one of claims 1 to 16, A stool collection device characterized in that the specimen collection device (500) further comprises a gripping segment (510) for inserting and / or removing the specimen collection device from the container.

18. In a stool collection device according to any one of claims 1 to 17, A stool collection device further comprising a protective function configured to prevent stool from being held in segments of the sample collection device other than the sample collection segment (530).

19. In the stool collection device according to claim 18, A stool collection device characterized in that the protective function is selected from a cap segment (550) temporarily attached to the tip (532) of the sample collection tool and a cavity extension (423) extending from the sample collection tool cavity (422).

20. In the stool collection device according to claim 4, A stool collection device characterized in that the opening (410) comprises the sample collection device cavity (422) and an additional cavity extension (423) configured to prevent contact between the stool in the container and any segment of the sample collection device other than the sample collection segment (530).

21. In the stool collection device according to claim 20, A stool collection device characterized in that the cavity extension (423) and / or the tip (532) of the sample collection device (500) have a chamfered edge to prevent the accumulation of excess sample below the sample collection device (500).

22. In a stool collection device according to any one of claims 1 to 21, A stool collection device characterized in that the homogenization means (420) is rotated by a rack and gear mechanism.

23. In a stool collection device according to any one of claims 1 to 22, A fecal collection device further comprising a fixing element configured to fix the container inside a toilet bowl.

24. In the stool collection device according to claim 23, A stool collection device characterized in that the fixing element is selected from the group consisting of a bracket (200) and a lateral strip (211) including an adhesive (212).

25. In a stool collection device according to any one of claims 1 to 24, A stool collection device characterized in that the collected stool sample is used for the quantitative measurement of target substances.

26. In the stool collection device according to claim 25, A stool collection device characterized in that the quantitatively analyzed substance indicates a disease, disorder, health condition, or any combination thereof in the subject being collected.

27. In the stool collection device according to claim 25 or 26, A stool collection device characterized in that the quantitatively analyte is nucleic acid or protein.

28. In a stool collection device according to any one of claims 1 to 27, A stool collection device characterized in that the sample collection segment (530) comprises at least one groove (535).

29. In a stool collection device according to any one of claims 1 to 28, A stool collection device characterized in that the at least one groove (535) is arranged on the side surface of the specimen collection tool facing the direction of rotation.

30. A method for collecting a predetermined amount of homogenized stool sample, (a) A step of providing a stool collection device, wherein the stool collection device comprises a stool receiving container (300) configured to be placed on a toilet bowl, and a lid (400) for sealing the container (300) after stool has been obtained in the container, the lid (400) housing a vertical sample collection tool (500) extending from an opening (410) of the lid (400) and positioned eccentrically from the center of the lid (400), the sample collection tool (500) including a distal sample collection segment (530) facing the container (300) when sealed, the sealing of the container (300) being performed by rotating the lid (400), thereby enabling the stool to be mixed and broken down by the rotating sample collection tool (500) and to be held on the sample collection segment (530), (b) The step of fixing the container (300) inside the toilet bowl, (c) The step of putting feces into the container (300), (d) The step of sealing the container (300) with the lid (400), (e) a method comprising the step of removing the sample collection device (500) from the lid (400) and thereby collecting a predetermined amount of homogenized stool sample onto the sample collection segment (530).

31. In the method according to claim 30, A method characterized in that the container (300) in step (b) is fixed using a bracket (200) or a lateral strip (211).

32. In the method according to claim 30 or 31, The method is characterized in that the sealing of the container (300) in step (d) is performed by rotating the lid (400) until it can no longer be rotated and / or until sensory feedback is obtained.

33. In the method according to claim 30, A method characterized in that the lid (400) is rotated at least twice.

34. In the method according to any one of claims 30 to 33, The aforementioned preset amount is 2 to 20 mm ３ A method characterized by being equivalent to the volume of [a certain value].

35. In the method according to any one of claims 30 to 34, A method further comprising the step of inserting the removed specimen collection device (500) into a tube (600) containing a predetermined amount of diluent.

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