Stool sample collecting device and method thereof

Abstract

A collecting device for biologic samples comprises a container and a lid that accommodates a longitudinal sample collector off-center. In one aspect, the device specifically collects homogenized stool samples through a rotating mechanism that mixes the sample and loads a predetermined quantity onto the sample collector.

Description

STOOL SAMPLE COLLECTING DEVICE AND METHOD THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application takes priority from U.S. Provisional Patent Application No. 63 / 544,210, filed on Oct. 15, 2023, titled “Stool Sample Collecting Device and Method Thereof’, herein incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention is in the field of stool sample devices and methods for collecting and analyzing stool samples.BACKGROUND OF THE INVENTION

[0003] Stool sample collection holds significant importance due to its potential for diagnosing a wide range of medical conditions and diseases. The composition and characteristics of stool provide valuable insights into various aspects of health, including: 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; identification of infections; monitoring digestive health; assessment of nutritional status, including food allergies; screening for colorectal cancer; evaluation of digestive enzymes and monitoring and treatment of chronic conditions and research.

[0004] The determination of quantitative analytes within stool samples has emerged as a critical aspect of medical diagnostics, particularly for gastrointestinal conditions. Biochemical markers such as calprotectin are instrumental in diagnosing and monitoring diseases such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), infections, and other gastrointestinal disorders. Accurate measurement of calprotectin levels within stool samples can provide valuable insights into inflammatory processes, aiding in the differential diagnosis and management of these conditions.

[0005] Current diagnostic practices often require patients to collect stool samples at home and transport them to healthcare facilities for stool sample testing, which can be inconvenient and uncomfortable, leading to non-compliance. For example, fecal calprotectin (FC) home tests still require user handling with feces; the user must manually sample their stool in at least three different places using a collection stick to ensure homogeneous sampling. Moreover, users might struggle to gather an exact or uniform amount. Over- or under-sampling can lead to inaccurate test results, affecting the reliability of the diagnosis. Home-based stool collection devices that allow for the collection of a predetermined small amount of stool either for transport to healthcare facilities or for at home testing, could offer an attractive solution. However, for these devices to be effective, they must ensure accurate collection and homogenization of stool samples to provide reliable quantitative analyte measurements.

[0006] Home-based stool sample collection for the collected stool to be tested brings about specific challenges, including the variability in stool consistency and the need to minimize direct human contact with the sample. The collection device must be capable of accommodating various stool consistencies, from liquid or semi-solid to solid, and ensure thorough mixing of the sample to avoid discrepancies in analyte concentrations. Additionally, the device should facilitate precise loading of the stool sample onto a sample collector, which is critical for consistent and accurate analytical results.

[0007] The need for home -based collection devices capable of such precision is underscored by the rising trend of personalized medicine and the increasing demand for convenient diagnostic solutions. These devices can empower patients to manage their health more effectively, reduce the burden on healthcare facilities, and enhance the overall accuracy and efficiency of gastrointestinal diagnostics and monitoring.SUMMARY OF THE INVENTION

[0008] It is an object of the present invention to disclose a stool collecting device for collecting a predetermined amount of homogenized stool sample, comprising: a stool receiving container configured to be placed upon a toilet; a lid for sealing the container after the stool is obtained within the container; the lid accommodates a longitudinal sample collector extending from anopening on the lid and located off-center of the lid; the sample collector comprises a distal sample collecting segment facing the container upon sealing; wherein sealing the container is by rotating the lid, leading to mixing and breakdown of the stool by the rotated sample collector; allowing sample loading onto the sample collecting segment.

[0009] It is another object of the present invention to disclose a stool collecting device as disclosed herein, further comprising at least one homogenizing means extending from the inner side of the lid, wherein rotating the lid, leads to mixing and breakdown of the stool by the rotated homogenizing means and the sample collector; allowing sample loading onto the sample collecting segment.

[0010] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein removal of the sample collector from the lid removes excess stool sample, leaving a predetermined amount of homogenized stool sample on the sample collecting segment.[Oi l] It is another object of the present invention to disclose a stool collecting device as disclosed herein, further comprising a sample collector cavity extending from the opening to accommodate the sample collector.

[0012] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the at least one homogenizing means is selected from the group consisting of a mixer element, a scraper, impeller, propeller, rotor, agitator, mixer, paddle, spinner, blade, turbine, auger, spring-loaded mechanism, and any combination thereof.

[0013] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the at least one homogenizing means comprises a mixer element that rotates around the center of the container as well as around its own axis.

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

[0015] It is another object of the present invention to disclose a stool collecting device as disclosed herein, further comprising at least one fixed projection protruding from the internal side of the container, configured to prevent the stool from rolling, aggregating or sticking to the container walls or floor.

[0016] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the at least one fixed projection is selected from a central projection extending upward from the central bottom surface of the container, a floor projection distributed along the bottom surface, and wall projections that extend radially inward.

[0017] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the sealing between the container and the lid is by a central sealing mechanism.

[0018] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the sealing between the container and the lid is by a peripheral sealing mechanism.

[0019] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the central sealing mechanism comprises engagement between a hollowed projection extending downward from the lid and a central projection or a central threaded pin extending from the central portion of the container.

[0020] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the central sealing mechanism comprises rising of the central threaded pin, allowing rotation of the sample collector at a minimal height of the sample collector from the bottom surface of the container from the start of the rotation.

[0021] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the lid further comprises at least one chamber for securing a tube configured to accommodate the sample collector.

[0022] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the opening further comprises means of securing the sample collector within the opening.

[0023] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the sample collector cavity comprises dimensions that strictly correlate with the sample collector to allow for the removal of excess sample volume loaded on the sample collector 500 upon its removal from the lid.

[0024] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the sample collector further comprises a gripping segment for introducing and / or removing the sample collector from the container.

[0025] It is another object of the present invention to disclose a stool collecting device as disclosed herein, further comprising a protective feature configured to prevent stool loading on segments of the sample collector other than the sample collecting segment.

[0026] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the protective feature is selected from a capping segment temporarily attached to the end tip of the sample collector, and a cavity extension extending from the sample collector cavity.

[0027] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the opening comprises the sample collector cavity and an additional cavity extension configured to prevent contact between the stool within the container and any segments of the sample collector other than the sample collecting segment.

[0028] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the cavity extension and / or an end tip of the sample collector comprise a beveled edge to prevent excess accumulation of the sample beneath the sample collector.

[0029] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the homogenizing means are rotated by a rack and gear mechanism.

[0030] It is another object of the present invention to disclose a stool collecting device as disclosed herein, further comprising securing elements configured to secure the container within a toilet.

[0031] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the securing elements are selected from the group consisting of a bracket, and lateral strips comprising adhesive.

[0032] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the collected stool sample is for use in measurement of a quantitative analyte.

[0033] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the quantitative analyte is indicative of a disease disorder health status, or any combination thereof in a subject in need thereof.

[0034] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the quantitative analyte is a nucleic acid or a protein.

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

[0036] It is another object of the present invention to disclose a stool collecting device as disclosed herein, wherein the at least one groove is positioned on the side of the sample collector that faces the direction of rotation.

[0037] It is another object of the present invention to disclose a method for collecting a predetermined amount of homogenized stool sample, comprising: (a) providing a stool collecting device comprising: a stool receiving container configured to be placed upon a toilet; a lid for sealing the container after the stool is obtained within the container; the lid accommodates a longitudinal sample collector extending from an opening on the lid and located off-center of the lid; the sample collector comprises a distal sample collecting segment facing the container upon sealing; wherein sealing the container is by rotating the lid, leading to mixing and breakdown of the stool by the rotated sample collector; allowing sample loading onto the sample collecting segment; (b) securing the container within the toilet; (c) passing stool into the container; (d) sealing the container with the lid; and, (e) removing the sample collector from the lid, thereby collecting a predetermined amount of homogenized stool sample on the sample collecting segment.

[0038] It is another object of the present invention to disclose a method as disclosed herein, wherein securing the container in step (b) is with a bracket or lateral strips.

[0039] It is another object of the present invention to disclose a method as disclosed herein, wherein sealing the container in step (d) is by rotating the lid until no further rotation is possible and / or until sensory feedback is provided.

[0040] It is another object of the present invention to disclose a method as disclosed herein, wherein rotating the lid is for at least 2 rounds.

[0041] It is another object of the present invention to disclose a method as disclosed herein, wherein the predetermined amount corresponds to a volume of between 2 and 20 mm3.

[0042] It is another object of the present invention to disclose a method as disclosed herein, further comprising a step of inserting the removed sample collector to a tube comprising a predetermined volume of diluent.BRIEF DESCRIPTION OF THE DRAWINGSExemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein be considered as being illustrative, rather than restrictive. The disclosure, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

[0043] Figs. 1A-1C are perspective views of a stool collecting device 100 positioned over a toilet 50, comprising a bracket 200, a stool receiving container 300, a lid 400, and a longitudinal sample collector 500, according to some embodiments of the invention;

[0044] Fig. ID is a perspective view of a stool collecting device 100, showing the stool receiving container 300, the lid 400, the longitudinal sample collector 500, and the lateral strips 211 with adhesive 212;

[0045] Fig. 2 is a cross-sectional view of a stool collecting device 100, illustrating the internal configuration and components, including the central fixed projection 312, homogenizing means 420, sample collector cavity 422, and the sample collector 500 removed from the opening 410 in the lid 400;

[0046] Figs. 3A-3C are perspective views of a stool receiving container;

[0047] Fig. 3D shows a perspective view of a central threaded pin 313 and a fastener 314;

[0048] Fig. 3E is an exploded view of the container including the central threaded pin and the fastener;

[0049] Fig. 4A is a perspective view of the lid 400 with handle 411, sample collector cavity 422, homogenizing means 420, and the sample collector 500. Fig. 4B is a bottom view of the lid 400 showing the sample collector cavity 422 and homogenizing means 420. Fig. 4C is a bottom perspective view of the lid 400 illustrating the hollowed projection 424 and multiple homogenizing means 420;

[0050] Fig. 5A is a top perspective view of the collecting device lid, illustrating components such as the lid, handle, sample collector cavity, hollowed projection, and gripping segment;

[0051] Figs. 5B-5C are bottom perspective views of the lid, displaying elements including the mixer element, sample collector cavity, gear mechanism, and hollowed projection;

[0052] Figs. 6A -6B are perspective views of the sample collector. Fig. 6C is a cross-sectional view of the sample collector integrated into the lid;

[0053] Fig. 7A shows a front view of various embodiments of a longitudinal sample collector 500;

[0054] Figs. 7B-7D are close-up perspective views of different configurations of the groove 535 and tip532;

[0055] Fig. 8A shows a perspective side view of a longitudinal sample collector 500, detailing the gripping segment 510, longitudinal segment 520, sample collecting segment 530 with the groove 535, and locking element 511;

[0056] Fig. 8B shows an alternative configuration of the groove 535;

[0057] Fig. 8C show a side view featuring the sample collecting segment 530 of the longitudinal sample collector 500 within the cavity extension 423, showing the groove 535;

[0058] Figs. 8D-8G show illustrations of different capping segments;

[0059] Fig. 9A is a cross-sectional view of a stool collection device, depicting the internal components within the container, according to some embodiments of the invention;

[0060] Fig. 9B is a perspective view of the stool collection device showing the arrangement of the container and the lid from an overhead angle;

[0061] Figs. 9C-9D are side views of the stool collection device, illustrating the placement of the sample collector and the projections within the container;

[0062] Fig. 10 is a perspective cross-sectional view of the stool collection device highlighting the central threaded pin mechanism and internal projections; and,

[0063] Fig. 11 is an assembled perspective view of the stool collecting device showing the internal gear and mixer elements within the container.

[0064] Fig. 12 includes images of the sample collecting device, featuring different groove designs, after the operation of the device with various sample textures.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS DETAILED

[0065] The present invention, in certain embodiments, discloses a device designed for stool sampling, with potential applications in home environments. One of the major challenges in the quantitative analysis of stool analytes lies in the need to accurately measure the analyte concentration within a defined volume of a homogeneously mixed stool sample. Due to the wide variability in stool consistency, ranging from fully liquid to highly solid forms, and the unpredictability of stool volume, there is a need for a device that can address this variability challenge. Specifically, the device must be capable of homogenizing the stool and loading a precise volume onto a sample collector. Moreover, given the nature of stool as a biological material, it is also essential that the device minimizes human contact and view of the sample to ensure patient compliance with the sampling procedure. Designing a device that enables the collection of a predetermined amount of homogenized sample, while minimizing direct interaction or view of the sample, presents a significant challenge.

[0066] According to one aspect of the invention there is provided a stool collecting device 100 comprising (i) a stool receiving container 300, and (ii) a lid 400 for sealing the container 300, and for accommodating a longitudinal sample collector 500 in the container 300.

[0067] As used herein, the terms "stool receiving container" and "container" are interchangeably used.

[0068] As used herein, the terms "longitudinal sample collector" and "sample collector" are interchangeably used.

[0069] The device described in the present invention is designed to be placed upon a toilet for stool collection from a subject. Reference is now made to Figs. 1A-1D, showing a stool collecting device 100 according to some embodiments of the invention. The stool collecting device 100 comprises a stool receiving container 300, and a lid 400 configured to seal the container 300 after the stool is obtained. The lid 400 accommodates a longitudinal sample collector 500 extending from an opening 410 on the lid 400 and located off-center of the lid 400. The longitudinal sample collector 500 comprises a a distal sample collecting segment 530. In some embodiments, the sample collector 500 extends through the opening 410, so that the sample collecting segment 530 faces the container 300 upon sealing of the container with the lid.

[0070] As used herein, the term "sealing" refers to the act of closing the container with the lid by rotating the lid. It is understood that "sealing" does not necessarily imply an airtight or complete seal.

[0071] In some embodiments, sealing the container 300 is by rotating the lid 400, leading to mixing and breakdown of the stool by the rotated sample collector 500; allowing sample loading onto the sample collecting segment 530.

[0072] In the exemplary illustrations shown in Figs. 1A-1C, the device 100 is mounted on the toilet bowl 50 using a bracket 200. In some embodiments, the bracket 200 comprises at least one lateral and / or median support configured to be placed on the toilet. For example, the bracket 200 may include two lateral supports (Fig. IB), or may be shaped as a round shell that surrounds part of the container 300 (Fig. 1C). The bracket 200 and the container 300 may be held by a pin-notch mechanism or by means of adhesive. As shown in Fig. ID, the container 300 may alternatively be attached to the toilet using two lateral strips 211, which have adhesive 212 on the inner side facing the toilet bowl to ensure secure attachment of the container 300 to the toilet seat and / or bowl. In some embodiments, the adhesive area on the lateral strips is wide, allowing for the use of a less strong adhesive. This design ensures that the strips remain firmly in place due to the wide contact area, providing stability during attachment to the toilet seat and / or bowl. In some embodiments, it was found that the large surface area ensures secure positioning during use, while still allowing for easy removal of the strips after the operation is complete. Non-limiting examples of means of adhesive include, but are not limited to: double sided tape, glue, epoxy resin, cyanoacrylate, scotch tape, adhesive putty, contact cement, pressure sensitive adhesive, or any combination thereof.

[0073] Reference is now made to Fig. 2. The lid 400 is designed with an off-center opening 410, extending to a sample collector cavity 422, to accommodate the longitudinal sample collector 500.

[0074] As used herein, the term "opening" refers to a slit, a hole, a void, a chamber, a cavity, or any combination thereof.

[0075] In some embodiments, sample collector 500 has a cylindrical, a tubular, a columnar, a round, a cylinder, a rod shape, or any combination thereof.

[0076] The sample collector 500 comprises an external gripping segment 510 for introducing and / or removing the longitudinal sample collector from the container 300, a longitudinal segment 520, and a sample collecting segment 530, on which the sample is loaded.

[0077] Once the stool is obtained within the container 300, the subject places the lid 400, pre-loaded with the sample collector 500 within the sample collector cavity 422, onto the container 300 and seals it.

[0078] In the embodiment shown in Fig. 2, the sealing mechanism is centrally located between a fixed central projection 312 protruding upward from the internal side of the container 300 and a hollowed projection 424 extending downward from the lid 400. In some embodiments, the central projection 312 comprises a threaded sealing feature. The threaded sealing feature refers to a screwing thread or a bolt thread feature. The threaded sealing feature disclosed herein is configured to seal lid 400 on container 300 by a thread sealing mechanism.

[0079] During the sealing process, such as by rotating the lid 400, homogenizing means 420, which protrude from the inner portion of the lid 400, rotate, stir and homogenize the stool.

[0080] As used herein, "homogenizing means" refers to components or mechanisms configured to stir, mix, or agitate a substance to achieve a uniform or consistent mixture. It is understood that homogenizing means can be either fixed in place or capable of varying degrees of motion.

[0081] In some embodiments, homogenizing means 420 is selected from the group consisting of: impeller, propeller, rotor, agitator, mixer, paddle, spinner, blade, turbine, auger, spring-loaded mechanism, or any combination thereof.

[0082] In some embodiments, it was surprisingly found that homogenization of stool is more efficient using rotating mixer elements compared to propellers. These features promote a more consistent breakdown of the stool material, minimizing the occurrence of unprocessed clumps or areas of uneven texture that are often seen with propeller -based mixing systems. In some embodiments, the rotating mixer element is in a shape of a frame. 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 mixing element rotates around the center of the container as well as around its own axis. In some embodiments, the mixer element comprises sharp edges facing the direction of rotation, facilitating stool breakdown.

[0083] The container 300 may further comprise at least one fixed projection that protrudes from the internal side of the container 300. In some embodiments, the at least one fixed projection prevents the stool from sticking to and spreading along the sides of the container.

[0084] Simultaneously, as the lid 400 is rotated, the sample collector 500 positioned within the sample collector cavity 422 also rotates around the container 300, allowing a sufficient volume of the homogenized stool to be loaded onto the sample collecting segment 530.

[0085] It is understood that any of the fixed projections disclosed herein, including those that protrude from the container and / or from the lid, may also be used to aid in the homogenization of the stool. For example, the sample collector cavity 422 protruding from the lid 400, may be designed with a sharpened edge to facilitate stool breakdown while rotating within the container 300.

[0086] The container 300 may also include a securing element (e.g., pins 316) designed to secure the container within the bracket 200.

[0087] The device is designed such that rotating the lid 400 ensures that an appropriate homogenized volume of stool is loaded onto the sample collecting segment 530 by the end of the sealing process. Once this process is complete, the sample collector 500 can be removed. Removal of the sample collector also removes any excess stool from the sample collecting segment 530, leaving an accurate volume on the loading portion to enable precise quantitative determination of stool analytes. Still referring to Fig. 2, in some embodiments, the sample collector is attached to a capping segment 550, which is configured to prevent the loading of samples onto areas other than the collecting segment 530. Once the sample collector is removed, the capping segment 550 may remain within the container 300.

[0088] The structural design ensures that the sample is collected in a precise amount of stool without the need for direct human contact, enhancing the ease of use of the stool collecting device 100 and improving user compliance.

[0089] In some embodiments, the device 100 of the invention further comprises means of securing sample collector 500 within opening 410. Non-limiting examples for securing means include but are not limited to: grip pad, chuck, clamp, thread bore, tapped hole, pin-notch mechanism or any combination thereof. In some embodiments, means of securing is configured to prevent samplecollector 500 from moving around its axis while the container is rotated and / or to hold the sample collector in place so that the collecting segment faces the stool during rotation.

[0090] Figs. 3A and 3B show the stool receiving container 300 according to some embodiments of the invention. The container 300 is defined by a bottom surface 301 and container walls 302 that extend upward from the bottom surface 301. In the exemplified container illustrated in Fig. 3 A, the top of the container 300 features a threaded opening 305, which is configured to engage with a complementary threaded lid (not shown) for secure sealing.

[0091] In some embodiments, the threaded sealing feature is configured to seal lid 400 on container 300. In some embodiments, the top segment of the container comprises a threaded sealing feature. In some embodiments, the threaded sealing is a circumference threaded sealing. In some embodiments, central projection 312 comprises a threaded sealing feature. In some embodiments, the threaded sealing is a central threaded sealing. As used herein, the term "threaded sealing" refers to closing the container with the lid in a secure manner.

[0092] When comparing peripheral threads, located around the edges of a cylindrical part, with central threads, located at the core, the preference for central threads likely arises because they are less exposed to external loads and stresses. This minimizes the likelihood of binding effects, where the thread may become misaligned and stuck. Additionally, the central positioning of the thread distributes pressure more evenly, further enhancing reliability compared to peripheral threads.

[0093] Inside the container 300, various projections are designed to assist in the homogenization of the stool. A central projection 312 is positioned at the center of the bottom surface 301, extending upwards. Surrounding the central projection 312 are upward central projections 322, which further aid in breaking up the stool and preventing it from clustering. Additional floor projections 324 extend laterally from the base of the central projection 312 and from the bottom surface 301, contributing to the stirring mechanism. The container walls 302 may also feature multiple wall projections 320 that extend radially inward, providing additional interaction points to aid in the thorough mixing of the stool. Additional wall projections may extend radially outward from the central projection 312. An absorbent 350 material and / or structure may be included within the bottom section of the container 300, possibly embedded or integrated with the projections.

[0094] The absorbent 350 may be positioned with a gap above the bottom surface 301. It may include small holes, functioning like a sieve, to facilitate liquid transfer and remove excess fluid. Through the incorporation of these various projections and absorbent elements, the stool receiving container300 is designed to ensure effective mixing, prevent stool clustering, and absorb unwanted liquid residues.

[0095] In some embodiments, the top of the container is characterized by a diameter greater than bottom301 diameter. In some embodiments, the top of the container further comprises pins 316 configured to engage at least one groove on bracket 200. In some embodiments, the pins are configured to couple with the at least one groove on bracket 200. The pins 316 may be configured to secure container 300 within bracket 200 by a notch-pin mechanism.

[0096] In some embodiments, the at least one fixed projection protrude upward from the floor, or sideward from the wall or from the central projection, at an angle of at least 0°, at least 10°, or at least 15°, including any range or value in between. In some embodiments, the at least one fixed projection protrude upward from the floor at an angle of between 0° and 90°, between 80° and 90°, between 70° and 90°, between 0° and 75°, between 0° and 50°, or between 0° and 25°, including any value in between.

[0097] In some embodiments, the at least one fixed projection protruding from the internal side of the container (e.g., 312, 320, 322 and 324) prevents stool from being dragged.

[0098] In some embodiments, central projection 312 is located in the middle of the container. In some embodiments, the at least one fixed projection is configured to prevent the stool from forming a cluster, a bundle, a mass, a group, or an aggregate. In some embodiments, central projection 312 is configured to move stool from the middle of the container to the side of the container. In some embodiments, central projection 312 is configured to move stool from the middle of the container to the sample collector 500.

[0099] In some embodiments, at least one fixed projection 324 is continuous. In some embodiments, at least one fixed projection 324 is non-continuous. In some embodiments, at least one fixed projection 324 connects between central projection 312 and at least one wall projection 320.

[0100] In some embodiments, container 300 further comprises an absorbent 350 configured to absorb liquid. Non-limiting examples for such absorbent include sponge, membrane, paper, silica gel,zeolite, or any other combination thereof. As used herein, the term "liquid sample" refers to urine and water present in watery stool or diarrhea.

[0101] The absorbent may be used in some embodiments to concentrate the sample and to enhance the efficiency of homogenization.

[0102] In some embodiments, absorbent 350 is placed at inner side bottom of container 300. The absorbent 350 may extend from the bottom surface 301 to the walls 302 of the container. In some embodiments, the absorbent 350 is a physical absorbent. As used herein, the term "physical absorbent" refers to a filter placed at the bottom of the container. In some embodiments, between the filter and the bottom side of the container, there is a gap configured to accommodate the liquid sample after filtration. In some embodiments, the filter is made of a metal, a ceramic, a composite, a polymer, or any combination thereof.

[0103] Fig. 3C shows the stool receiving container 300 according to some embodiments of the invention. In some embodiments, it was found that a separate central threaded pin 313, as illustrated in Figs. 3D-3E, connected to the central portion of the bottom surface 301 e.g., by a fastener 314, is beneficial for collecting a stool sample from a relatively small amount of stool. By using this separate threaded mechanism, upon closing the container 300 with the lid 400, the sample collecting segment 530 can be positioned at a minimal height from the bottom surface 301. As the container 300 is sealed, the central threaded pin 313 rises, allowing the sample collector to rotate at a minimal height of the sample collecting segment 530 from the bottom surface from the start of the rotation, rather than lowering the sample collecting segment 530 during rotation. In some embodiments, the fastener disclosed herein may be a screw or a bolt.

[0104] The container wall 302 may be complemented with the lateral connector 360, positioned on either side of the container wall to connect the container with lateral strips 211 to aid in securing the container within the toilet bowl during use. Floor projections 324 may be distributed around the central threaded pin 313 and extend upwards from the bottom surface 301. These projections 324 are designed to prevent stool from clustering and may assist in stirring the sample to ensure uniform consistency.

[0105] Still referring to Fig. 3C, within the stool receiving container 300, a rack 303 may be integrated along the perimeter of the container wall 302. This rack 303 may serve as part of a rack gear mechanism designed for rotating homogenizing means 420, such as a stirrer.

[0106] As used herein, "rack gear mechanism" means a combination of a straight or linear gear known as the rack and a mating circular gear known as the pinion, such that the linear motion of the rack translates to rotational motion in the pinion, and vice versa. The rack typically comprises a series of evenly spaced teeth along a length of a substantially elongated, linear body. The pinion, which is a round gear with teeth designed to mesh with the teeth on the rack, engages the rack to allow for the conversion of linear to rotational motion.

[0107] In applications concerning a homogenizing means, the rack gear mechanism is utilized to rotate the homogenizing means by converting a linear force, applied to the rack, into a rotational force exerted on the pinion. This rotational force is then transmitted to the homogenizing means. For instance, in a homogenizing device for biologic substances, a linearly moving rack may engage a pinion connected to a rotating mixing blade or element. As the rack, circulating the upper portion of the container wall moves linearly, the pinion rotates, thereby driving the rotation of the mixing element to produce a homogenized mixture of the biologic substances.

[0108] In some embodiments, container 300 is disposable. In some embodiments, the container is biodegradable. In some embodiments, the container is rigid. In some embodiments, container 300 is made of composites, ceramics, polymers, or any combination thereof.

[0109] Figs. 4A-4C show a detailed view of the lid 400 of the stool sample collecting device according to some embodiments of the invention, along with its various integral components. The lid 400 is designed to securely seal the stool receiving container 300 and facilitate the homogenization of the stool during the sealing process. The lid 400 features a handle 411, which allows for easy handling and manipulation of the lid. In addition, it includes homogenizing means 420, which protrudes downward from the lid 400 into the container 300. The homogenizing means 420 is designed to engage with the stool upon closing the lid 400, ensuring thorough mixing and homogenization for accurate sampling. The lid 400 also includes off-center the sample collector cavity 422, specifically designed to accommodate the longitudinal sample collector 500, which is used to collect a precisely measured stool sample.

[0110] In some embodiments, the lid 400 further comprises at least one homogenizing means 420 configured to stir stool within the container. In some embodiments, at least one homogenizing mean 420 is configured to direct stirred stool to the sample collecting segment 530. In some embodiments, at least one homogenizing mean 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 mean 420 has a paddle custom made shape, based on the stirring needed.

[0111] Additionally, the lid 400 may feature a hollowed projection 424, configured to engage with the central fixed projection 312 or the central threaded pin 313 during the sealing process. Engagement with central threaded pin 313 enables the rotation of both the central threaded mechanism and the sample collector 500, ensuring that the sample collecting segment 530 remains at a minimal height from the bottom surface from the start of the sealing process.

[0112] Reference is now made to Figs. 5A-5C, illustrating the lid 400 and its internal operational components according to some embodiments of the invention. The lateral support elements 211, connected to the container 300 via the lateral connector 360, are designed to attach to the external toilet base. The lateral connectors 360 are preferably moon-shaped to facilitate the lateral stretching of the support elements 211. Handles 412 facilitate the rotation of the lid 400 by the user during sealing. The hollowed projection 424, which interacts with the central threaded pin 313 during the sealing process, is also shown.

[0113] The homogenizing components may include a scraper 421, designed to remove any sample remnants adhered to the container wall 302, and a mixer element 426. The mixer element 426 may be connected to a gear mechanism allowing 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 large gear 430 and small gear 431. In some embodiments, the large gear 430 and small gear 431 work in tandem, transferring motion to drive the mixer element 426. The mixer element may feature at least one sharpened edge to facilitate the breakdown of the sample.

[0114] The sample collector cavity 422 may be elongated with an additional cavity extension 423 that includes an opening to enable interaction between the sample collecting segment 530 and the stool sample. The cavity extension 423 may be designed with a beveled edge to prevent sampleaccumulation beneath the sample collector 500. It is also understood that the sample collector cavity 422 and the cavity extension 423 may be an integral part of a single continuous component.

[0115] Reference is now made to Figs. 6A-6C showing the sample collector 500 and its integration within the lid 400 according to some embodiments of the invention. Opening 410 within the lid 400 may further comprise means of securing gripping segment 510 of the sample collector 500 within opening 410. Non-limiting examples for means of securing include but are not limiting to threaded mechanism, grip pad, chuck, clamp, pin-notch mechanism, or any combination thereof. In some embodiments, opening 410 further comprises a protrusion 545 or a notch 540, configured to secure sample collector 500 by a pin-notch mechanism.

[0116] In some embodiments, opening 410 dimensions correlate with the sample collector 500 dimensions. In some embodiments, opening 410 is circular. In some embodiments, opening 410 is characterized by a diameter greater than sample collector longitudinal segment 520. In some embodiments, opening 410 is characterized by a diameter greater than the sample collecting segment 530.

[0117] In some embodiments, sample collector cavity 422 is located beneath opening 410. In some embodiments, opening 410 comprises the sample collector cavity 422. In some embodiments, sample collector cavity 422 is fixed to opening 410 side facing the container. In some embodiments, sample collector cavity 422 is located off-center of the lid.

[0118] The sample collector cavity 422 disclosed herein is configured to accommodate and protect the sample collector 500 during the stirring from mechanical and / or radial forces. In some embodiments, sample collector cavity 422 is configured to stir stool within container 300. In some embodiments, sample collector cavity 422 is configured to remove excess of stool from the sample collecting segment 530 or from other exposed components within the sample collector 500 upon its removal. In some embodiments, the cavity 422 dimensions are correlated with the sample collector longitudinal segment 520 to allow removal of excess stool sample upon sample collector removal. In some embodiments, the cavity side facing container 300 is characterized by a cone shape. In some embodiments, the cone-shaped cavity is configured to remove excess of stool during sample collector 500 removal.

[0119] In the example shown in Fig. 6C, the sample collector 500 length is greater than sample collector cavity 422. In some embodiments, sample collector cavity 422 edge facing the container is characterized by an angle of at least 5°, at least 10°, at least 15° of the cross-section of the cavity, including any value in between. In some embodiments, sample collector cavity 422 edge is characterized by an angle between 5° and 60°, between 5° and 50°, between 5° and 40°, or between 10° and 30° of the cross-section of the cavity configured, including any range or value in between.

[0120] In some embodiments, the cavity dimensions are configured to detach a capping segment 550 from sample collecting segment 530 during removal of sample collector 500 from lid 400.

[0121] In some embodiments, both sample collector gripping segment 510 and longitudinal segment 520 are accommodated within the lid. In other embodiments, longitudinal segment 520 is accommodated within sample collector cavity 422.

[0122] During stirring, sample collector 500 rotates and a stool sample is loaded on the sample collecting segment 530. Figs. 7A-7D show different examples for grooves 535 within the sample collecting segment 530.

[0123] The distal end of the longitudinal segment 520 transitions into the sample collecting segment 530. At the very end of the sample collecting segment 530 is the tip 532. The sample collecting segment 530 is equipped with at least one groove 535, which is strategically positioned to capture stool samples as the longitudinal sample collector 500 is rotated or moved within the container 300. These grooves 535 ensure that the collected sample is retained within the sample collecting segment 530 until the sample collector 500 is withdrawn from the container 300. The grooves 535 can vary in size and shape to accommodate different sample requirements and may be positioned at different heights and / or circumferentially around the sample collecting segment 530.

[0124] As used herein, the term "groove" means a notch, a crevice, a cavity, a recess, a slot, or any combination thereof. In some embodiments, the at least one groove 535 collects the stool sample, upon contacting the stool.

[0125] In some embodiments, at least one groove 535 is located on the sample collecting segment 530. In some embodiments, at least one groove 535 is located on the side of the sample that moves in conjugation with the sealing motion. In some embodiments, at least one groove 535 is oriented toward the stool upon sealing the container. In some embodiments, at least one groove 535 isoriented towards the stool upon stirring. In some embodiments, the grooves 535 are positioned on the side of the sample collector that faces the direction of rotation, allowing for maximal loading.

[0126] Figs. 8A-8C illustrate the sample collector 500 according to some embodiments of the invention. The tip 532 at the distal end of the sample collector 500 is designed with a beveled edge to minimize stool loading beneath the sample collector 500. Gripping segment 510 may include a locking element 511 to secure the sample collector within the tube 600 upon insertion.

[0127] In some embodiments, it was found that the cross-shaped grooves 535, as shown in Figs. 8B-8C, with curved corners, allow for complete filling of the groove, preventing any sample-free zones within the groove 535. In other embodiments it was found that a lip angle of about 90° allows for greater loading of the sample compared to a sloped lip.

[0128] In some embodiments, the groove dimensions are configured to hold a sample volume of 1 - 20 mm3, 1 - 15 mm3, 2 - 15 mm3, 1 - 10 mm3, 1 - 8 mm3, 2 - 8 mm3, or 3 - 8 mm3, or any range inbetween, after the sample collector is removed from the lid. Each possibility represents a separate embodiment of the present invention.

[0129] In some embodiments, the groove dimensions are configured to hold a sample volume of about 5 mm3after the sample collector is removed from the lid.

[0130] In the exemplified illustration, only the side of the sample collecting segment 530 is exposed, while the other parts of the sample collector are enclosed by the sample collector cavity 422 and the cavity extension 423. This configuration ensures accurate loading of the sample onto the sample collecting segment 530 when the sample collector 500 is removed. In some embodiments, the cavity extension 423 may be shaped like a pocket to secure the sample collector 500 in place. For example, the cavity extension may include a protrusion 425 that extends onto the front side of the distal tip of the sample collector 500.

[0131] The design of these elements allows the longitudinal sample collector 500 to operate efficiently with the stool sample collecting device, ensuring precise and hygienic sampling for further analysis.

[0132] Figs. 8D-8G show exemplary illustrations of the capping segment 550. The capping segment may comprise a plug 551 that is temporarily attached to the distal end of the sample collector, blockingdirect contact between the collecting segment 530 and the stool at the distal end of the sample collector (Figs. 8D-8E). The shape of the capping segment may be an inverted cone, where the maximum diameter of the cone is at its distal outer portion facing the stool sample. In some embodiments, the maximum diameter of the capping segment 550 is larger compared to the inner diameter of the opening 410 and / or the sample collector cavity 422. Once the sample collector is pulled out of the device 100, the capping segment 550 may be detached from the collector 500 and may remain within the container 300. Excess stool present on the outer surface of the stick 200 remains attached to the inner portion of the cavity 422, allowing the sampling of a predetermined amount of stool. The capping segment 500 may also be a detachable hollow cylinder 552 that temporarily wraps the distal portion of the sample collector 500 (Figs. 8F-8G). The capping segment may comprise an opening configured to allow direct contact between the grooves 535 and the stool sample. Similar to plug 551, capping segment 552 may also detach from the sample collector 500 once it is pulled out of the device 100. The capping segment may be made of a flexible material. Non-limiting examples of such flexible materials include silicone elastomers, polyurethane elastomers, thermoplastic elastomers (TPE), natural rubber, fluorosilicone rubber, ethylene propylene diene monomer (EPDM) rubber, etc.

[0133] Reference is now made to Figs 9A-9B, illustrating the device according to some embodiments of the invention. Figure 9A illustrates a lid 400 comprising a sample collector cavity 422 an additional separate homogenizing means 420. The homogenizing means 420 has a flat paddle shape. In some embodiments, homogenizing means 420 is configured to stir the stool within the container and direct the stirred stool to the sample collecting segment 530.

[0134] The lid 400 may further comprise at least one chamber on the top side of lid 400 (Fig. 9B). In some embodiments, the at least one chamber is configured to secure a tube 600. In some embodiments, lid 400 comprises chamber 450, configured to secure horizontally the tube 600 before use. Chamber 450 may also be used as a handle. In some embodiments, the lid comprises chamber 440 configured to secure the tube upon insertion of the sample collector loaded with the stool sample. In some embodiments, chamber 440 is a fixed projection protruding downwards from lid 400 into container 300. In some embodiments, chamber 450 is located in downward hollowed projection. As used herein, the term "top side" refers to the side opposite to container 300. In some embodiments, chamber 450 is at the same plane as opening 410. In some embodiments, chamber440 is located off-center to the lid. In some embodiments, chamber 440 is located at the center of lid 400. In some embodiment, chamber 450 and chamber 440 are in the same plane. In some embodiments, chamber 440 and opening 410 are at the same plane. In some embodiments, a tube 600 is configured to accommodate the collected stool sample collector 500.

[0135] In some embodiments, the tube 600 comprises a predetermined volume of diluent, for diluting the predetermined amount of the collected stool sample in the diluent for further analysis.

[0136] The device is further illustrated in Figs 9C-9D, exhibiting the sealed container 300 by lid 400. The container may comprise pins 316 configured to secure the container on bracket 200. The lid may further comprise chamber 440 configured to secure a tube 600.

[0137] Figs. 9C-9D and Fig. 10 show the device 100 in a sectional view, providing a detailed illustration of its various components and their spatial relationships. The container 300 may be equipped with at least one fixed projection, such as wall projections 320, a central projection (e.g., threaded pin 313), and floor projections 324 (Fig. 9C), which are designed to prevent stool from adhering to the inner surfaces of the container and to facilitate the homogenization process. The container 300 may further include a rack 303 (Fig. 9D) configured to engage with the homogenizing means 420 and facilitate the rotation of the homogenizing means 420 via a rack-and-gear mechanism.

[0138] As illustrated in Fig. 9D, upon rotating the lid 400, the hollowed projection 424 extending downward from the lid interacts with the central threaded pin 313, causing the pin 313 to rise in the Z direction. This mechanism positions the sample collecting segment 530 at a minimal distance from the bottom surface 301 from the start of the lid’s rotation, allowing for maximum contact time between the sample collecting segment and the stool within the container. This feature is especially important when only a small amount or low level of stool is collected in the container, ensuring effective contact and sample collection even with low sample content.

[0139] Fig. 11 provides a detailed perspective of the internal components of the stool sample collecting device. Central to the configuration is the central threaded pin 313. Multiple floor projections 324 are positioned at the bottom of the container, preventing the stool from sticking to the surface and aiding in the mixing process and sample homogenization. In some embodiments, as the lid 400 is rotated, the sample collector 500 passes between the floor projections 324. This positions thesample collecting segment 530 at a minimal height above the bottom surface 301 during rotation, allowing for the homogenization of a very small or low sample amount.

[0140] In the embodiment illustrated in Fig. 11, the rack 303 lines the upper inner circumference of the container 300. Once the lid 400 is placed on the container 300 and rotated, a small gear 431 engages with a corresponding large gear 430, enabling rotational motion for various homogenization and collection processes within the device. Specifically, in some embodiments, a mixer element 426 protrudes downward from the large gear 430 and rotates accordingly. The mixer element 426 may be hollow, rectangular in shape, with sharpened edges facing the direction of rotation to facilitate mixing and cutting of the stool. Other possible shapes for the mixer element include cylindrical, elliptical, or trapezoidal designs, each contributing distinctively to the efficiency of the mixing process.

[0141] In some embodiments, the presence of the central sealing mechanism allows for the integration of the circumferential rack-and-gear mechanism, which facilitates the rotation of the homogenizing means. While the current invention focuses on manual homogenization, where the user rotates the lid to operate the homogenizing means, it is understood that automatic means may also be employed to facilitate the rotation of the homogenizing means 420. An example of such automatic means is an integrated electric motor coupled with the lid 400.

[0142] During rotation, the sample collecting segment 530 gathers a sufficient amount of the stool sample, while any excess sample is removed upon extraction of the sample collector from the lid. In some embodiments, it was found that at least 2 full 360-degree rotations are required for sufficient loading of the sample onto the sample collecting segment 530. In some embodiments, at least 2.5, 3, 3.5, 4, 4.5, 5, 5.5 or 6 full 360-degree rotations are required to fully fill the grooves 535 within the sample collecting segment 530. In some embodiments, it was found that full loading of the sample onto the sample collecting segment 530 within the collecting device disclosed herein can be achieved with less than 3 rotations. In some embodiments, between 1.5 and 3.5 rounds are required for sufficient loading of the sample onto the sample collecting segment 530.

[0143] The sample collector 500 may then be inserted into a tube 600 and transported to another location for further analysis, or stored, for the examination of an analyte within the sample.

[0144] In some embodiments, introducing and removing the sample collector is done manually, through automation, or any combination thereof.

[0145] In some embodiments, the device 100 is made of metal, composites, ceramics, polymers, 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, polyvinylchloride, nylon, polycarbonate, polyoxymethylene, polyethylene terephthalate, fluoropolymers, polyesters (e.g., polyhydroxyalkanoates), polyglycolic acid, polycaprolactane, polylactic acid, polystyrene, cellulose, lignin, hemicellulose, starch (e.g., amylose, amylopectin) or any combination thereof. In some embodiments, device 100 or any part thereof is made of pulped paper, cardboard, or any combination thereof.

[0146] As used herein, the term Cl -CIO polyalkenes refers to polymers derived from Cl -CIO alkene monomers. As used herein, the term Cl -CIO alkenes refers to alkenes comprising 2, 3, 4, 5, 6, 7, 8, 9 or 10 carbon atoms, for example, ethylene, propylene, butylene, isopropylene. As used herein the term alkenes, refers to a hydrocarbon comprising a double bound.

[0147] 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. As used herein, the term "biodegradable" refers to a material, substance, or product that in the presence of microorganisms such as bacteria or fungi, is broken down to smaller substances over time such as water, organic matter, and carbon dioxide.

[0148] A skilled in the art can appreciate that device 100 may include additional or fewer elements.

[0149] In some embodiments, the collected stool sample is for use in analyte level measurement methods, analyte detection methods, analyte monitoring methods, or any combination thereof in a subject.

[0150] In some embodiments, the analyte detected within the sample is a protein or nucleic acid whose quantitative level correlates with a disease or disorder. In some embodiment, the analyte is used for disease or disorder monitoring.

[0151] In some embodiments, the analyte detected within the sample reflects the health status of a subject. In particular, the analyte may indicate the health status of the subject's digestive system or gut (e.g., microbiome).

[0152] In some embodiments, the subject is a mammal. In some embodiments, the subject is human.

[0153] In some embodiments, non-limiting examples of analyte level measurement methods include but are not limited to: spectroscopy, chromatography, mass spectroscopy, fluorescence, luminescence, electrophoresis, immunoassays, lateral flow assays, or any combination thereof.

[0154] Non-limiting examples of stool analyte detection methods include but are not limited to: chemical analyzer, polymerase chain reaction, lateral flow immunoassay, fecal fat analysis setup, flow cytometer, mass spectrometer, microbiome sequencing equipment, or any combination thereof.

[0155] In some embodiments, the analyte is a quantitively diagnostic marker for disease or disorder. In some embodiments, the predetermined amount of stool is used for a quantitative measurement of the analyte disclosed herein.

[0156] As used herein, the term "analyte" encompasses a protein, a nucleic acid, a cell, or any combination thereof.

[0157] In some embodiments, it was found that the device disclosed herein can be used for calprotectin measurement.

[0158] It is appreciated that, although the device is primarily designed for quantitative analyte determination, it may also be used for non -quantitative analytes. In some embodiments, the detection is of a medical condition, medical disease, microorganisms, or any combination thereof.

[0159] In some embodiments, the medical condition or medical disease is selected from the group consisting of: gastrointestinal disorder, irritable bowel syndrome, inflammatory bowel disease, infections, allergies, or cancer, including any combination thereof.

[0160] In some embodiments, microorganism is selected from the group consisting of: bacteria, viruses, fungi, parasites, archaea, or any combination thereof.

[0161] According to another aspect, there is provided a method for collecting a predetermined amount of homogenized stool sample, comprising:(a) providing a stool collecting device comprising: a stool receiving container 300 configured to be placed upon a toilet; a lid 400 for sealing the container 300 after the stool is obtained within the container; the lid 400 accommodates a longitudinal sample collector 500 extending from anopening 410 on the lid 400 and located off-center of the lid 400; the sample collector 500 comprises a distal sample collecting segment 530 facing the container 300 upon sealing; wherein sealing the container 300 is by rotating the lid 400, leading to mixing and breakdown of the stool by the rotated sample collector 500; allowing sample loading onto the sample collecting segment 530;(b) securing the container 300 within the toilet;(c) passing stool into the container 300;(d) sealing the container 300 with the lid 400; and,(e) removing the sample collector 500 from the lid 400, thereby collecting a predetermined amount of homogenized stool sample on the sample collecting segment 530.

[0162] In some embodiments, providing in step (a) is of a stool collecting device as disclosed herein, further comprising at least one homogenizing means 420 extending from the inner side of the lid 400, wherein sealing the container 300 is by rotating the lid 400, leadings to mixing and breakdown of the stool by the the rotated homogenizing means 420 and the sample collector 500; allowing sample loading onto the sample collecting segment 530.

[0163] In some embodiments, sealing the container 300 in step (d) is by rotating the lid 400 until no further rotation is possible and / or until sensory feedback is provided.

[0164] As used herein, the term "sensory feedback" encompasses at least one audio, visual, or tactile notification. Non-limiting examples for audio notifications include beep sounds, voice alerts, alarm tone, melodic chimes. Examples for visual notifications include LED indicator lights, display screen messages, flashing lights, icons, and etc. Tactile notifications provide physical feedback through touch. Non-limiting examples may include click or snap, vibration feedback, resistance increase, and haptic pulses.

[0165] As used herein, the term "about" when combined with a value refers to plus and minus 20% of the reference value.

[0166] It is appreciated that the terms "sample collector", "sample collector stick" and "longitudinal sample collector" are interchangeably used.EXAMPLE 1

[0167] The device 100 disclosed herein was tested for its ability to collect a predetermined amount of samples, with sample textures ranging from liquid to solid, using sample collectors 500 that feature different collecting grooves 535. The results are shown in Fig. 12 and Table 1.

[0168] Table 1 - Different weights of collected solid and liquid samples.

[0169] Results showed that for more solid stool textures, sticks #1 and #2 provided the best results, whereas for more liquid stool texture, sticks # 1 and # 4 provided the best performance.

[0170] Grooves oriented directly towards the stool were more effective than those positioned to the side.

[0171] Wider grooves demonstrated better performance compared to very thin and widely spaced grooves.

[0172] When the stool level was low, such as with small-sized or watery stool, grooves that were positioned in a higher position were not fully filled. Therefore, it would be beneficial to position the grooves lower to improve collection efficiency in these conditions.

[0173] Unexpectedly, the best results were achieved with stick # 5, which featured perpendicular grooves, performing well with both semi-solid and solid samples.

Claims

CLAIMSWhat is claimed is:

1. A stool collecting device 100 for collecting a predetermined amount of homogenized stool sample, comprising: a stool receiving container 300 configured to be placed upon a toilet; a lid 400 for sealing said container 300 after the stool is obtained within said container; said lid 400 accommodates a longitudinal sample collector 500 extending from an opening 410 on said lid 400 and located off-center of said lid 400; said sample collector 500 comprises a distal sample collecting segment 530 facing the container 300 upon sealing; wherein sealing said container 300 is by rotating said lid 400, leading to mixing and breakdown of said stool by the rotated sample collector 500; allowing sample loading onto said sample collecting segment 530.

2. The stool collecting device of claim 1 , further comprising at least one homogenizing means 420 extending from the inner side of said lid 400, wherein rotating said lid 400, leads to mixing and breakdown of said stool by said rotated homogenizing means 420 and said sample collector 500; allowing sample loading onto said sample collecting segment 530.

3. The stool collecting device of claim 1 or 2, wherein removal of said sample collector 500 from said lid 400 removes excess stool sample, leaving a predetermined amount of homogenized stool sample on said sample collecting segment 530.

4. The stool collecting device of any one of claims 1 to 3, further comprising a sample collector cavity 422 extending from said opening 410 to accommodate said sample collector 500.

5. The stool collecting device of claim 2, wherein said at least one homogenizing means 420 is selected from the group consisting of a mixer element 426, a scraper 421, impeller, propeller, rotor, agitator, mixer, paddle, spinner, blade, turbine, auger, spring-loaded mechanism, and any combination thereof.

6. The stool collecting device of claim 2, wherein said at least one homogenizing means 420 comprises a mixer element 426 that rotates around the center of the container 300 as well as around its own axis.

7. The stool collecting device of claim 2, wherein said at least one homogenizing means 420 comprises a paddle shaped - or a frame shaped - mixer element 426.

8. The stool collecting device of any one of claims 1 to 7, further comprising at least one fixed projection protruding from the internal side of said container 300, configured to prevent the stool from rolling, aggregating or sticking to the container walls or floor.

9. The stool collecting device of claim 8, wherein said at least one fixed projection is selected from a central projection 312 extending upward from the central bottom surface of the container, a floor projection 324 distributed along said bottom surface, and wall projections 320 that extend radially inward.

10. The stool collecting device of any one of claims 1 to 9, wherein said sealing between said container 300 and said lid 400 is by a central sealing mechanism.

11. The stool collecting device of any one of claims 1 to 9, wherein said sealing between said container 300 and said lid 400 is by a peripheral sealing mechanism.

12. The stool collecting device of claim 10, wherein said central sealing mechanism comprises engagement between a hollowed projection 424 extending downward from said lid 400 and a central projection 312 or a central threaded pin 313 extending from the central portion of said container 300.

13. The stool collecting device of claim 12, wherein said central sealing mechanism comprises rising of the central threaded pin 313, allowing rotation of said sample collector 500 at a minimal height of the sample collector from the bottom surface 301 of said container 300 from the start of the rotation.

14. The stool collecting device of any one of claims 1 to 13, wherein said lid 400 further comprises at least one chamber for securing a tube 600 configured to accommodate said sample collector 500.

15. The stool collecting device of any one of claims 1 to 14, wherein said opening 410 further comprises means of securing said sample collector 500 within said opening 410.

16. The stool collecting device of claim 4, wherein said sample collector cavity 422 comprises dimensions that strictly correlate with the sample collector 500 to allow for the removal of excess sample volume loaded on said sample collector 500 upon its removal from said lid 400.

17. The stool collecting device of any one of claims 1 to 16, wherein said sample collector 500 further comprises a gripping segment 510 for introducing and / or removing said sample collector from said container.

18. The stool collecting device of any one of claims 1 to 17, further comprising a protective feature configured to prevent stool loading on segments of the sample collector other than said sample collecting segment 530.

19. The stool collecting device of claim 18, wherein said protective feature is selected from a capping segment 550 temporarily attached to the end tip 532 of the sample collector, and a cavity extension 423 extending from said sample collector cavity 422.

20. The stool collecting device of claim 4, wherein said opening 410 comprises said sample collector cavity 422 and an additional cavity extension 423 configured to prevent contact between the stool within said container and any segments of the sample collector other than said sample collecting segment 530.

21. The stool collecting device of claim 20, wherein said cavity extension 423 and / or an end tip 532 of said sample collector 500 comprise a beveled edge to prevent excess accumulation of the sample beneath the sample collector 500.

22. The stool collecting device of any one of claims 1 to 21 , wherein said homogenizing means 420 are rotated by a rack and gear mechanism.

23. The stool collecting device of any one of claims 1 to 22, further comprising securing elements configured to secure the container within a toilet.

24. The stool collecting device of claim 23, wherein said securing elements are selected from the group consisting of a bracket 200, and lateral strips 211 comprising adhesive 212.

25. The stool collecting device of any one of claims 1 to 24, wherein said collected stool sample is for use in measurement of a quantitative analyte.

26. The stool collecting device of claim 25, wherein said quantitative analyte is indicative of a disease disorder health status, or any combination thereof in a subject in need thereof.

27. The stool collecting device of claim 25 or 26, wherein said quantitative analyte is a nucleic acid or a protein.

28. The stool collecting device of any one of claims 1 to 27 wherein said sample collecting segment 530 comprises at least one groove 535.

29. The stool collecting device of any one of claims 1 to 28 wherein said at least one groove 535 is positioned on the side of said sample collector that faces the direction of rotation.

30. A method for collecting a predetermined amount of homogenized stool sample, comprising:(a) providing a stool collecting device comprising: a stool receiving container 300 configured to be placed upon a toilet; a lid 400 for sealing said container 300 after the stool is obtained within said container; said lid 400 accommodates a longitudinal sample collector 500 extending from an opening 410 on said lid 400 and located off-center of said lid 400; said sample collector 500 comprises a distal sample collecting segment 530 facing the container 300 upon sealing; wherein sealing said container 300 is by rotating said lid 400, leading to mixing and breakdown of said stool by the rotated sample collector 500; allowing sample loading onto said sample collecting segment 530;(b) securing said container 300 within said toilet;(c) passing stool into said container 300;(d) sealing said container 300 with said lid 400; and,(e) removing said sample collector 500 from said lid 400, thereby collecting a predetermined amount of homogenized stool sample on said sample collecting segment 530.

31. The method of claim 30, wherein said securing said container 300 in step (b) is with a bracket 200 or lateral strips 211.

32. The method of claim 30 or 31, wherein said sealing said container 300 in step (d) is by rotating said lid 400 until no further rotation is possible and / or until sensory feedback is provided.

33. The method of claim 30, wherein said rotating said lid 400 is for at least 2 rounds.

34. The method of any one of claims 30 to 33, wherein said predetermined amount corresponds to a volume of between 2 and 20 mm3.

35. The method of any one of claims 30 to 34, further comprising a step of inserting the removed sample collector 500 to a tube 600 comprising a predetermined volume of diluent.

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