System and method for urine collection

Abstract

A system and method for collection and separation of midstream urine including a sample cup with a lid configured to collect a first urine portion, and a cup insert mounted within the sample cup configured to collect a second urine portion.

Description

[0001] SYSTEM AND METHOD FOR URINE COLLECTION

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority under 35 USC § 119(e) of U.S. provisional patent application no. 63 / 706,751 filed October 14, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to a system and method for urine collection and, more particularly, but not exclusively, for collection and / or separation of midstream urine.

[0006] A urine test is a medical test that is performed frequently in the general population and includes a chemical test and a urine culture test. Urine is normally sterile, however there is a risk of the sample being contaminated with bacteria from a user’s hands or skin around the urethra, since the urethra is not sterile, and is located near the female or male genital organ, as well as near the anus, when urinating, bacteria that are in the genital area or on the skin can be collected in the first stream of the urine. Further, many urine sample tests results are inconclusive due to non-ideal sample collection, i.e., the first urine stream is contaminated with non-urine tract originated bacteria. Therefore, a midstream urine (MSU) sample is preferred when testing a urine sample.

[0007] A MSU sample describes the middle part of the urine flow. However, collecting only the midstream flow and not the first part of urine flow is difficult and currently requires a user to pass a sample collector through a stream of urine without allowing the sample container to touch the user’s skin. Many users find it difficult to assess when to collect the urine sample from the urine stream. Additionally, the currently used method for urine collection is not ideal, as users are getting their hands covered in urine.

[0008] Therefore, there is a need for a system and method for simple and efficient midstream urine separation and collection. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0010] In the drawings:

[0011] Figs. 1A-B: Schematic diagrams illustrating a system for collecting urine, in accordance with some embodiments.

[0012] Figs. 2A-B: Schematic diagrams illustrating a top and side view, respectively, of a system for collecting and separating urine, in accordance with some embodiments.

[0013] Figs. 3A-B: Schematic diagrams illustrating a cross-section and expanded view, respectively, of a system for collecting urine and separating, in accordance with some embodiments.

[0014] Figs. 4A-B: Schematic diagrams illustrating a cross-section and expanded view, respectively, of a system for collecting urine and separating, in accordance with some embodiments.

[0015] Fig. 5: Schematic diagram illustrating a system for collecting urine, in accordance with some embodiments.

[0016] Figs. 6A-B: Schematic diagrams illustrating a system for collecting urine in open and closed configurations, respectively, in accordance with some embodiments.

[0017] Fig. 7: A block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention.

[0018] Fig. 8: A flow chart illustrating a method for use of the system for collecting and separating urine, in accordance with some embodiments of the invention.

[0019] Figs. 9A-D: Schematic diagrams illustrating cut-away views of a system for collecting urine, in accordance with some embodiments. Figs. 10A-H: Schematic diagrams illustrating various views of a cup insert, in accordance with some embodiments.

[0020] Figs. 11A-D: Schematic diagrams illustrating a system for collecting urine in open and closed configurations, respectively, in accordance with some embodiments.

[0021] Figs. 12A-B: Schematic diagrams illustrating a reverse system for collecting urine, in accordance with some embodiments.

[0022] Figs. 13A-H: Schematic diagrams illustrating a system for collecting urine, in accordance with some embodiments.

[0023] Figs. 14A-C: Schematic diagrams illustrating collection of urine, in accordance with some embodiments.

[0024] Fig. 15: A block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention.

[0025] Fig. 16: A flow chart illustrating a method for use of the system for collecting and separating urine, in accordance with some embodiments of the invention.

[0026] Figs. 17A-C: Schematic diagrams illustrating systems for collecting and separating urine, in accordance with some embodiments of the invention.

[0027] Fig. 18: A block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention.

[0028] Fig. 19: A flow chart illustrating a method for use of the system for collecting and separating urine, in accordance with some embodiments of the invention.

[0029] SUMMARY OF THE INVENTION

[0030] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.

[0031] In one general aspect, system may include a sample cup with a lid configured to collect a first urine portion. System may also include a cup insert, where the cup insert is mounted within the sample cup, and where said cup insert is configured to collect a second urine portion. System may furthermore include characterized in that the cup insert includes an opening and a flap, optionally located on a base of said cup insert, and where the flap is configured to seal the opening on accumulation of urine within said cup insert. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0032] Implementations may include one or more of the following features. System where the cup insert is fitted within the sample cup by a connector. System where the cup insert is integral to the sample cup. System where the lid is selected from a threaded cap, screw -on lid, snap-on lid, press-and-seal lid, ribbed lid, or a child-proof lid. System where the opening is configured for a slower fluid flow rate than an average rate of urination. System where a fluid flow rate out of the opening is controlled, at least in part, by a size and shape of the opening. System where the opening has a diameter ranging between about 0.1 mm to about 5 mm. System where the opening includes a funnel. System where the flap is integral to the cup insert. System where the flap is anchored to the cup insert along at least one side. System where the flap is anchored above the opening, below the opening, adjacent to the opening, or within the opening or a component thereof. System where the flap is configured to deform, bend or rotate under a weight or pressure of the urine accumulated in the cup insert. System where the flap includes a thinner portion configured to bend or rotate. System where the flap includes one or more slits along or adjacent to at least one unanchored side of said flap. System where the slits are configured to facilitate passage of urine. System where the slits have a concave shape. System where the slits are configured to be closed by a weight or pressure of the urine accumulated in the cup insert. Implementations of the described techniques may include hardware, a method or process, or a computer tangible medium.

[0033] In one general aspect, the method collection may include initiating urination. The method collection may also include passing a first portion of urine into a cup insert, and then through an opening past a flap in an open configuration and into a sample cup. Collection may furthermore include accumulating said first urine portion in the sample cup. Collection may in addition include accumulating a second urine (MSU) portion in the cup insert due to a difference in fluid flow rates between a flow rate of urine entering the cup insert and a flow rate of urine flowing out of the cup insert through the opening. Collection may moreover include converting said flap from an open configuration to a closed configuration by a weight of the urine in the cup insert, thereby sealing the opening and inhibiting further flow through said opening. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0034] Implementations may include one or more of the following features. The method may include configuring said opening for a slower fluid flow rate than an average rate of urination. The method may include controlling the fluid flow rate out of the opening, at least in part, by a size and shape of the opening. The method where said converting the flap from an open configuration to a closed configuration is through rotating said flap about an integral joint. The method where said converting the flap from an open configuration to a closed configuration is through bending or deforming said flap. The method may include passing the first portion of urine into the sample cup through a funnel in the opening. The method may include passing the first portion of urine into the sample cup through one or more slits located along or adjacent to at least one unanchored side of the flap. The method may include sealing the sample cup with a lid for storage and transportation. Implementations of the described techniques may include hardware, a method or process, or a computer tangible medium.

[0035] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0036] The present invention, in some embodiments thereof, relates to a system and method for urine collection and, more particularly, but not exclusively, for collection and / or separation of midstream urine.

[0037] OVERVIEW

[0038] Some embodiments relate to a system and method for safe and efficient urine collection. Optionally, the system and method may maintain urine integrity in terms of chemical parameters and microbial load. Optionally, the system and method may maintain the sterility of the urine for a medical examination. Optionally, the system may be configured to collect urine for analysis. Optionally, the system may be configured to collect midstream urine for analysis. Optionally, the system may be configured to separate midstream urine for analysis. Optionally, the system may be configured to collect non -first flow urine for analysis. In some embodiments, the system may be configured to separate midstream urine such that the tested urine consists of midstream urine, rather than the initial stream, as the latter is potentially contaminated with non-urine tract originated bacteria. Additionally or alternatively, in some embodiments, the system may reduce the occurrence of inconclusive urine sample tests due to non-ideal sample collection, i.e., the tested urine includes both initial and midstream urine.

[0039] According to some embodiments, the system may be configured to collect and / or separate, and / or store urine. Optionally, the system may store urine in a sterile manner. Optionally, the system may facilitate urine extraction for laboratory testing (e.g., chemical testing, biological testing such as culture testing, etc.). Optionally, urine may be extracted from the system by a vacuum sample collector, syringe, integrated transfer device, etc.

[0040] According to some embodiments, the system may include a cup insert. Optionally, the system may include a urine collection cup, cup insert and a lid. Optionally, the cup insert may be mounted to the inside of a standard urine collection cup (sample cup). Optionally, the cup insert may be fitted within a standard urine collection cup by a connector. Optionally, the connector may be an O-ring. Optionally, the connector may include a vent to facilitate the escape of air. Optionally, the cup insert may be integral to a standard sized urine collection cup. Optionally, a first portion of urine may be trapped in the cup insert. Optionally, a first portion of urine may be trapped in the sample cup. Optionally, a second portion of urine may be trapped in the cup insert. Optionally, a second portion of urine may be trapped in the sample cup.

[0041] According to some embodiments, the system may be sealed with a lid and / or cap for storage and / or transportation. Optionally, the lid may be a threaded cap, screw- on lid, snap-on lid, press-and-seal lid, ribbed lid, or a child-proof lid. Optionally, the lid may be reversibly removable. Optionally, the lid may be waterproof and / or air proof. Optionally, the lid may include an opening and / or port configured for extraction of urine.

[0042] According to some embodiments, the cup insert may include an opening in the insert. Optionally, the opening may be in the base of the cup insert and / or near the bottom thereof. Optionally, the opening may be in and / or along a side of the cup insert. For example, the base portion may include the bottom 1 / 10 of the cup insert and / or the botom 1 / 20 of the cup insert and / or the botom 1 / 40 of the cup insert and / or the botom 1 / 50 of the cup insert and / or the floor of the cup insert. Optionally, the opening may be small. Optionally, the opening may include a hole. Optionally, the opening may include a funnel. Optionally, the funnel may be narrow. Optionally, the funnel may include one, two or more rails. Optionally, the rails may be located on either side of the funnel slope. Optionally, the rails may include one or more indentations and / or protuberances.

[0043] According to some embodiments, the opening may be configured for urine to pass from the cup insert through the opening into the outer sample cup (standard sample cup). Optionally, the opening may be small to pass urine slowly from the cup insert into the outer cup. Optionally, the rate of urine flow from the cup insert into the outer cup may be dependent on the size and / or shape of the opening. Optionally, the size and / or shape of the opening may facilitate accumulation of fluid in the cup insert. For example, the opening may be configured such that a flow of urine through the opening will be less than a rate of urination. Optionally, the opening may be small. Optionally, the small size of the opening may provide a good seal and / or easy activation by the urine flow. Optionally, the opening may have a diameter and / or width range in size from 0.1 mm to about 1 mm, and / or between about 1.0 mm to about 5 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm, and / or between about 0.1 mm to about 5 mm.

[0044] According to some embodiments, the system may include an absorbent material. Optionally, the absorbent material may include a plurality of absorbent particles. Optionally, the absorbent material may be configured to absorb urine. Optionally, the absorbent material may be a hydrophilic polymer. Optionally, the absorbent material may form a hydrogel on absorption of urine. Non-limiting examples of absent materials include: Polyacrylic Acid (PAA), Polyvinyl Alcohol (PVA), Carboxymethyl Cellulose (CMC), Hydroxyethyl Cellulose (HEC), Polyethylene Glycol (PEG), Polyacrylamide (PAM), Alginate, Agarose, Gelatin, Starch, Cellulose, Chitosan, Dextran, or combinations thereof. Optionally, the absorbent material may be configured to absorb any first stream contaminants along with the first portion of the urine. Optionally, the absorbent material may be configured avoid contamination as midstream passes over saturated particles. Optionally, the saturation capacity of the absorbent material may facilitate absorption of the first portion of urine without absorbing the second portion of urine. According to some embodiments, the cup insert may include an absorbent material. Optionally, the absorbent material may be configured to absorb a first portion of urine. Optionally, the absorbent material may be configured to facilitate passage of a second portion of urine into the sample cup, e.g., once the saturation capacity of the absorbent material has been reached, the second portion of urine may pass between particles of the absorbent material. Optionally, the absorbent material may be configured to prevent passage of a second portion of urine into the sample cup, e.g., the absorbent material may absorb a first portion of urine to become a hydrogel, preventing passage of a second portion of urine, trapping the second portion of urine above hydrogel layer. Optionally, a first portion of urine and a second portion of urine may be separated by absorption of a first portion of urine by an absorbent material.

[0045] According to some embodiments, the absorbent material may be configured to preferentially absorb various microorganisms and / or chemical compounds. Optionally, the absorbed portion of the urine may undergo laboratory testing, e.g., chemical testing, biological testing such as culture testing, etc. Optionally, the absorbent material may include one or more layers of absorbent materials. Optionally, each layer of absorbent material may be configured to absorb a different organism and / or compound. Optionally, the various layers may be configured to filter various sizes of particles and / or contaminants and / or compounds. Optionally, each layer may be configured to absorb a different urine portion. Optionally, the layer with the desired urine portion may undergo laboratory testing. For example, the first layer that the urine contacts (e.g., a top layer) may absorb and / or adsorb fluid and / or contaminants from the first stream urine. Optionally, the top layer may be configured to filter particles and contaminants that are not of interest, while lower layers may be configured to filter particles and contaminants that are of interest, or vice versa.

[0046] In some embodiments, one or more layers may include a reagent, for example, a growth media. For example, a top layer may not facilitate growth of microorganisms, while lower layers may include growth media to culture microorganisms. Optionally, organisms in the first stream urine will be trapped in the top layer and / or will not be exposed to the growth media and / or will not grow. Later as the sorption capacity of the upper layer becomes saturated, organisms in the midstream will optionally pass through the top layer and be absorbed in the lower layers where they may be adsorbed and / or be cultured. Alternatively or additionally, the layers may be separated and / or exposed to different conditions to test for reagents and / or culture organism preferentially. Optionally, the absorbent material may include and / or may be growth media. Optionally, the growth media may be configured to culture colonies of microorganism.

[0047] According to some embodiments, the sample cup and / or cup insert may include an absorbent material configured to absorb urine. Optionally, the absorbent material may prevent contamination of the urine sample and / or there may be a barrier to prevent recontamination and / or mixing between the absorbed first stream urine and the midstream urine.

[0048] According to some embodiments, the system may include a mechanical means of separating urine portions. Optionally, the mechanical separation means may include an elastic flap. Optionally, the weight and / or pressure of the fluid may force the flap open and / or closed. Optionally, the mechanical separation means may include a freely moving member. For example, a freely moving member may include a revolving divider (e.g., a revolving door). Optionally, the weight and / or pressure of the fluid may cause movement from an open configuration to a closed configuration, or vice versa. Optionally, the mechanical separation means may include a valve. Optionally, the valve may be a one-way valve. Optionally, the valve may be configured to open and / or close due to the weight and / or pressure and / or buoyancy of the fluid, e.g., a float valve. Optionally, the valve may be configured to close after a predetermined time after the start of urination. Optionally, the valve may be configured to close after passage of a predetermined amount of urine. Optionally, the valve may be configured to facilitate passage of a first portion of urine and then close to trap a second portion of urine. Optionally, the valve may be a two-way valve, e.g., the valve may direct a first portion of urine to one location and then switch to direct a second portion of urine to a second location. Optionally, the valve may lock in a closed configuration and / or in a second state to prevent contamination of the second portion of urine. Optionally, the second urine portion may be maintained separate from the first urine portion by gravity. Optionally, mechanical separation may prevent contamination of the urine sample.

[0049] According to some embodiments, the mechanical separation mechanism may be combined with an absorbent material to facilitate separation of various portions of a urine sample and / or prevent contamination of the urine sample, e.g., a first portion of urine may be absorbed by an absorbent material, then a valve may be switched preventing contamination of a second portion of urine; a first portion of urine may pass through a valve, then the valve may be switched and a second portion may be absorbed by an absorbent material, preventing contamination of a second portion of urine, etc. Optionally, a first urine portion may be absorbed by an absorbent material, the weight of the heavily saturated material may rotate a door, and / or close a valve and / or seal a flap, thereby trapping a second urine portion. Optionally, the second urine portion may bypass the absorbent material. Optionally, a first urine portion may be absorbed by an absorbent material, the weight of the heavily saturated material may rotate a door, and / or close a valve and / or seal a flap, thereby trapping a second urine portion, such that the second urine portion may bypass the absorbent material. Optionally, a first urine portion may pass through a door, and / or a valve and / or a flap, where it may be trapped by an absorbent material, thereby preventing contamination and / or spillage and / or mixing with a second urine portion.

[0050] According to some embodiments, the cup insert may include a flap. Optionally, the flap may be located at the base of the cup insert. Optionally, the flap may be located within the cup insert in the vicinity of the opening. Optionally, the flap may be integral to the cup insert. Optionally, the flap and cup insert may be a single molded piece. Optionally, the flap and cup insert may be formed separately and / or assembled together. Optionally, the flap may be anchored to the cup insert along one or more sides. Optionally, the flap may be anchored above the opening. Optionally, the flap may be anchored below the opening. Optionally, the flap may be anchored adjacent to and / or within the funnel. According to some embodiments, the flap may be sealed against the opening. Optionally, the flap may be sealed against one or more rails of a funnel.

[0051] According to some embodiments, the flap may be located at the base of the cup insert. Optionally, the flap may be located within the cup insert in the vicinity of the opening. Optionally, the flap may be integral to the cup insert. Optionally, the flap and the cup insert may be a single molded piece. Optionally, the flap, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, the flap and the cup insert may be formed separately and / or assembled. Optionally, the flap may be anchored above the opening. Optionally, the flap may be anchored below the opening. Optionally, the flap may be anchored along one or more sides. Optionally, the flap may be connected on both sides by a thin integral joint. Optionally, the flap may include the slits along and / or adjacent to the unanchored sides. Optionally, the flap includes one or more slits along and / or adjacent to at least one unanchored side of the flap. Optionally, the slits may be configured to facilitate urine flow between the two sides of the flap and the cup insert. Optionally, the flap may be sealed against the opening. Optionally, when pressure is applied (e.g., by a flow of urine), the flap may bend towards the center, over the opening, sealing the slits and preventing further flow of fluid though the opening. Optionally, the slits may have a concave shape. Optionally, the slits may have a shape that corresponds to the way the flap may bend (e.g., a parabolic shape), to create maximum sealing. Optionally, the slits which facilitate flow may be closed easily by applying pressure from the fluid from above, and / or rising from below. Optionally, a mechanism may be robust and / or may not be prone to failure and / or breakage.

[0052] According to some embodiments, the flap may include multiple configurations. Optionally, in an open configuration, the flap may facilitate passage of fluid through the opening. Optionally, the flap may be biased up and / or in the open configuration when the sample cup and / or cup insert is empty. Optionally, in a closed configuration, the flap may prevent passage of fluid through the opening. Optionally, fluid in the cup insert may push the flap downward into the closed configuration. Optionally, the weight of the fluid in the cup insert may close and / or seal the flap in the closed configuration. For example, when the fluid in the cup insert reaches a threshold volume and / or mass the fluid may push the flap from the open configuration to a closed configuration.

[0053] Additionally, or alternatively, according to some embodiments, the flap may be biased downward and / or in the open configuration when the sample cup and / or cup insert is empty. Optionally, in a closed configuration, the flap may prevent passage of fluid through the opening. Optionally, fluid in the sample cup may push the flap upwards into the closed configuration. For example, when the fluid in the sample cup reaches a threshold volume and / or height the fluid may push the flap from the open configuration to a closed configuration.

[0054] According to some embodiments, the flap may include a hinge and / or pivot. Alternatively or additionally, a flap may include a flexible and / or elastic element. Optionally, the flap may include be configured to rotate about an axis due to the pressure and / or weight of the urine. Optionally, the flap may be configured to prevent passage of a first urine portion. Optionally, the flap may include a container configured to catch a first portion of urine. Optionally, the flap and / or the container may include absorbent material. Optionally, the weight of the heavily saturated absorbent material may rotate the flap about an axis. Optionally, rotation of the flap may direct a first urine portion into a cup insert. Optionally, rotation of the flap may drive the flap from an open configuration to a closed configuration. Optionally, the flap may close and / or seal the cup insert once the flap has completed its rotational arc. Optionally, in the closed configuration, the rotated flap may trap a first urine portion. Optionally, in the closed configuration, the rotated flap may facilitate passage of a second urine portion into the sample cup. in the closed configuration, the rotated flap may facilitate separation of the first urine portion and the second urine portion. Optionally, in the closed configuration, the rotated flap may prevent contamination of the second urine portion.

[0055] According to some embodiments, the flap may be composed of a flexible and / or elastic material. Optionally, the flap may be deformed by the pressure and / or weight and / or volume of the urine. Optionally, deformation of the flap may, at least in part, seal the opening.

[0056] According to some embodiments, the flap may be rigid and / or semi-rigid. Optionally, the pressure and / or weight and / or volume of the urine may, at least in part, force the flap into a position to seal the opening.

[0057] According to some embodiments, the flap may include a mechanism to maintain the flap in the closed position, e.g., a locking mechanism. Optionally, the locking mechanism may maintain the flap in the closed position to prevent rough handling and / or time to cause remixing of the urine portions. For example, the locking mechanism may include an interference element.

[0058] According to some embodiments, the flap, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, the weight of the fluid in the cup insert may close the flap. Optionally, the pressure of the fluid in the sample cup may close the flap. Optionally, the amount of fluid in the cup insert required to close the flap may depend on the thickness and / or flexibility of the flap and / or a portion thereof. Optionally, the thickness of the flap may range between about 0.01 mm to about 0.1 mm, and / or between about 0.1 mm to about 0.5 mm, and / or between about 0.5 mm to about 1 mm, and / or between about 1 mm to about 5 mm.

[0059] According to some embodiments, the flap may include one or more thinner portions. Optionally, the thinner portion may connect between the base of the cup insert and the flap. Optionally, the thinner portion may anchor the flap to the cup insert. Optionally, the thinner portion may be an integral joint. Optionally, the flap may rotate about the integral joint. Optionally, the flap may bend about the integral joint. Optionally, the integral joint may rotate and / or bend between a position horizontal to gravity to a position vertical to gravity. Optionally, the integral joint may rotate and / or bend between the open configuration and the closed configuration ranging between less than 5° and / or between 5 to 10° and / or between 10 to 15° and / or between 15 to 30°, and / or between 30° to about 45°, and / or between about 45° to about 60° from parallel to the base of the cup insert.

[0060] According to some embodiments, the cup insert and / or the flap may be composed of a hydrophobic material, e.g., to prevent fluid from adhering to the surface of the cup insert and / or the flap. Optionally, the hydrophobic material may be configured to prevent first flow urine from sticking to the cup insert. Optionally, the sample cup, the cup insert and / or the flap may be sterile.

[0061] According to some embodiments, the system may be configured to separate various portions of urine. Optionally, the first urine portion may be stored in the sample cup, below the cup insert. Optionally, the second urine portion may be stored in the cup insert, away from the first urine portion.

[0062] According to some embodiments, the first urine portion may range in volume from about 0.1 ml to about 1 ml, and / or between about 1 ml to about 10 ml, and / or between about 10 ml to about 100 ml. Optionally, the amount of urine in the first urine portion may be dependent on parameters including, urination rate, size of the opening, shape of the opening, size of the flap, flexibility of the flap, weight of the flap, fluid flow rate through the opening relative to the fluid flow rate into the cup insert, etc. and / or any combination thereof.

[0063] In some embodiments, the cup insert may leave space in the bottom of the sample cup under the cup insert for first flow urine. For example, the space may be less than about 5 ml and / or between about 5 to about 15 ml and / or between about 15 to about 30 ml.

[0064] According to some embodiments, the system may be configured to prevent fluid from returning through the opening and / or pushing the flap open. Optionally, the base of the cup insert may be sufficiently distant from the base of the sample cup to prevent fluid from returning through the opening and / or pushing the flap open. Optionally, the flap may include a mechanism to maintain the flap in the closed position, e.g., a locking mechanism. Optionally, the locking mechanism may maintain the flap in the closed position to prevent rough handling and / or time to cause remixing of the urine portions.

[0065] Some embodiments may relate to a method for collecting and / or separating various urine portions, e.g., separating the first flow from the mid-flow. Optionally, a user may collect urine in a urine sample cup including a cup insert. Optionally, on initiation of urination, urine may pass into the cup insert, through an opening in the base of the cup insert, into the sample cup. Optionally, this first urine portion may accumulate in the base of the sample cup. Optionally, the flap may be in the open configuration, e.g., the opening may not be covered by the flap. Optionally, the opening may be configured for a slower fluid flow rate than the average rate of urination, e.g., the fluid flow rate into the cup insert may be faster than the fluid flow rate out of the opening in the cup insert. Optionally, the fluid flow rate into the cup insert may be much faster than the fluid flow rate out of the opening in the cup insert. Optionally, the fluid flow rate out of the opening may be controlled, at least in part, by the size and / or shape of the opening. Optionally, due to the difference in fluid flow rates, fluid may accumulate in the cup insert. Optionally, the weight of the fluid in the cup insert may force the flap into the closed configuration. Optionally, in the closed configuration, the flap may block the opening, thereby stopping the flow of urine through the opening into the sample cup. Optionally, this mechanism may separate the first urine portion from the second urine portion. Optionally, the sample cup may be sealed with a lid and / or cap for storage and / or transportation.

[0066] According to some embodiments, the system may be for use in a healthcare institute, e.g., clinic, hospital, doctor’s office, care facility, sports facility, etc. Optionally, the system may be for use in homecare. Optionally, the system may be portable. Optionally, the system may facilitate urine testing. Optionally, the system may be cheap and / or simple to manufacture.

[0067] SPECIFIC EMBODIMENTS

[0068] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0069] Reference is now made to the figures:

[0070] Figs. 1A-B are schematic diagrams illustrating a system for collecting and separating urine, in accordance with some embodiments. For example, the system may include a sample cup 11, a cup insert 10, and a lid 14. Optionally, cup insert 10 may be mounted to the inside of a standard urine collection cup (sample cup 11). Optionally, cup insert 10 may be fitted within a standard urine collection cup with a connector (not shown). Optionally, the connector may be an O-ring. Optionally, the connector may include a vent to facilitate the escape of air. Optionally, cup insert 10 may be integral to a standard urine collection cup. Optionally, the first urine portion (unwanted urine) 16 may be collected in the base of sample cup 11. Lid 14 may be configured for storage and / or transportation. Optionally, the lid may be a threaded cap, screw-on lid, snap-on lid, press-and-seal lid, ribbed lid, or a child-proof lid. Optionally, lid 14 may be reversibly removable. Optionally, lid 14 may be waterproof and / or air proof. Optionally, lid 14 may include an opening and / or port configured for extraction of urine.

[0071] Figs. 2A-B are schematic diagrams illustrating a top and side view, respectively, of a system for collecting urine and separating, in accordance with some embodiments. For example, the system may include a sample cup 18 and a cup insert 20 for midstream urine collection. Optionally, cup insert 20 may include an opening 22 located in the base thereof. Optionally, the cup insert may include a flap (not shown).

[0072] Figs. 3A-B are a cross-section and expanded view, respectively, of schematic diagrams illustrating a system for collecting and separating urine, in accordance with some embodiments. For example, the system may include a sample cup 24 and a cup insert 26. Optionally, cup insert 26 may include an opening 28 located in the base thereof. Optionally, opening 28 may include a funnel 32. Optionally, cup insert 26 may include a flap 30. Optionally, the flap may be located at the base of cup insert 26. Optionally, flap 30 may be located within cup insert 26 in the vicinity of opening 28. Optionally, flap 30 may be integral to cup insert 26. Optionally, flap 30 and cup insert 26 may be a single molded piece. Optionally, flap 30 and cup insert 26 may be formed separately and / or assembled. Optionally, flap 30 may be anchored above opening 28. Optionally, flap 30 may be anchored below opening 28. Optionally, flap 30 may be anchored adjacent to and / or within the funnel 32. Optionally, flap 30 may be sealed against opening 28. Optionally, flap 30 may be sealed against one or more rails of a funnel 32. Optionally, flap 30 may include thinner portion. Optionally, the thinner portion may connect between the base of cup insert 26 and flap 30. Optionally, the thinner portion may be an integral joint. Optionally, flap 30 may rotate and / or bend about the integral joint. Optionally, the integral joint may rotate and / or bend between the open configuration and the closed configuration ranging between less than 5° and / or between 5 to 10° and / or between 10 to 15° and / or between 15 to 30°, and / or between 30° to about 45°, and / or between about 45° to about 60° from parallel to the base of the cup insert. Optionally, under the weight of accumulating urine, the integral joint may rotate and / or bend flap 30, which may seal against the funnel 32, preventing further flow from cup insert 26 through opening 28 into sample cup 24.

[0073] Figs. 4A-B are a cross-section and expanded view, respectively, of schematic diagrams illustrating a system for collecting and separating urine, in accordance with some embodiments. For example, the system may include a sample cup 34 and a cup insert 36. Optionally, cup insert 36 may include an opening 38 located in the base thereof. Optionally, opening 38 may be small. Optionally, the small size of opening 38 may provide a good seal and / or easy activation by the urine flow. Optionally, opening 38 may have a diameter and / or width range in size from 0.1 mm to about 1.0 mm, and / or between about 1.0 mm to about 5.0 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm. Optionally, opening 38 may be a hole. Optionally, opening 38 may include a funnel 40. Optionally, funnel 40 may be narrow. Optionally, funnel 40 may include two rails. Optionally, the rails may be located on either side of the funnel slope. Optionally, cup insert 36 may include a flap (not shown). Optionally, the flap may be located at the base of cup insert 36. Optionally, the flap may be located within cup insert 36 in the vicinity of opening 38. Optionally, the flap may be integral to cup insert 36. Optionally, the flap and cup insert 36 may be a single molded piece. Optionally, the flap and cup insert 36 may be formed separately and / or assembled. Optionally, the flap may be anchored above opening 38. Optionally, the flap may be anchored below opening 38. Optionally, the flap may be anchored adjacent to and / or within the funnel 40. Optionally, the flap may be sealed against opening 38. Optionally, the flap may be sealed against one or more rails of a funnel 40. Optionally, the flap may include thinner portion. Optionally, the thinner portion may connect between the base of cup insert 36 and the flap. Optionally, the thinner portion may be an integral joint. Optionally, the flap may rotate and / or bend about the integral joint. Optionally, under the weight of accumulating urine, the integral joint may rotate and / or bend the flap, which may seal against the funnel 40, preventing further flow from cup insert 36 through opening 38 into sample cup 34.

[0074] Fig. 5 is a schematic diagram illustrating a system for collecting urine, in accordance with some embodiments. For example, the system may include a sample cup 42 and a cup insert 44. Optionally, cup insert 44 may include an opening 46 located in the base thereof. Optionally, opening 46 may include funnel 48. Optionally, cup insert 44 may include a flap 50. Optionally, the flap may be located at the base of cup insert 44. Optionally, flap 50 may be located within cup insert 44 in the vicinity of opening 46. Optionally, flap 50 may be integral to cup insert 44. Optionally, flap 50 and cup insert 44 may be a single molded piece. Optionally, flap 50 and cup insert 44 may be formed separately and / or assembled. Optionally, flap 50 may be anchored above opening 46. Optionally, flap 50 may be anchored below opening 46. Optionally, flap 50 may be anchored adjacent to and / or within the funnel 48. Optionally, flap 50 may be sealed against opening 46. Optionally, flap 50 may be sealed against one or more rails of a funnel 48. Optionally, flap 50, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, flap 50 may include thinner portion 52. Optionally, thinner portion 52 may connect between the base of cup insert 44 and flap 50. Optionally, thinner portion 52 may be an integral joint. Optionally, flap 50 may rotate and / or bend about the integral j oint. Optionally, under the weight of accumulating urine, the integral joint may rotate and / or bend flap 50, which may seal against the funnel 48, preventing further flow from cup insert 44 through opening 46 into sample cup 42. Optionally, the weight of fluid in cup insert 44 may close flap 50. Optionally, the amount of fluid in cup insert 44 required to close flap 50 may depend on the thickness and / or flexibility of flap 50 and / or a thinner portion 52 thereof.

[0075] Figs. 6A-B are schematic diagrams illustrating a system for collecting and separating urine in open and closed configurations, respectively, in accordance with some embodiments. For example, the system may include a sample cup 60 and a cup insert 58. Optionally, cup insert 58 may include an opening 62 located in the base thereof. Optionally, cup insert 58 may include a flap 54. Optionally, the flap may be located at the base of cup insert 58. Optionally, flap 54 may be located within cup insert 58 in the vicinity of opening 62. Optionally, flap 54 may be integral to cup insert 58. Optionally, flap 54 and cup insert 58 may be a single molded piece. Optionally, flap 54 and cup insert 58 may be formed separately and / or assembled. Optionally, flap 54 may be anchored above opening 62. Optionally, flap 54 may be sealed against opening 62. Optionally, flap 54 may include thinner portion 56. Optionally, thinner portion 56 may connect between the base of cup insert 58 and flap 54. Optionally, thinner portion 56 may be an integral joint. Optionally, flap 54 may rotate and / or bend about the integral joint. Optionally, in an open configuration, flap 54 may facilitate passage of urine 64 through opening 62. Optionally, flap 54 may be biased up and / or open when the sample cup and / or cup insert is empty. Optionally, in a closed configuration, flap 54 may prevent passage of urine 64 through opening 62. Optionally, the weight of the urine 64 in cup insert 58 may push flap 54 into the closed configuration. Optionally, the weight of the urine 64 in cup insert 58 may seal flap 54 in the closed configuration. Optionally, flap 54 may be sealed against opening 62. Optionally, flap 54 may be sealed against one or more rails of a funnel. Optionally, flap 54 may include a mechanism to maintain flap 54 in the closed position, e.g., a locking mechanism. Optionally, the locking mechanism may maintain flap 54 in the closed position to prevent rough handling and / or time to cause remixing of the urine portions.

[0076] Fig. 7 is a block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention. For example, system 66 may include a sample cup 68 and a cup insert 70, wherein cup insert 70 may include an opening and a flap 72 located on the base thereof. Optionally, flap 72 may be configured to seal the opening from within cup insert 70 on accumulation of urine within the cup insert.

[0077] Fig. 8 is a flow chart illustrating a method for use of the system for collecting and separating urine, in accordance with some embodiments of the invention. For example, in method 74 for collecting and / or separating various urine portions, e.g., separating the first flow from the mid-flow. Optionally, a user may collect urine in a urine sample cup including a cup insert. Optionally, on initiation 76 of urination, urine may pass 78 into the cup insert, through an opening in the base of the cup insert, into the sample cup. Optionally, this first urine portion may accumulate 80 in the base of the sample cup. Optionally, the flap may be in the open configuration, e.g., the opening may not be covered by the flap. Optionally, the opening may be configured for a slower fluid flow rate than the average rate of urination, e.g., the fluid flow rate into the cup insert may be faster than the fluid flow rate out of the opening in the cup insert. Optionally, the fluid flow rate into 82 the cup insert may be much faster than the fluid flow rate out of the opening in the cup insert. Optionally, the fluid flow rate out of the opening may be controlled, at least in part, by the size and / or shape of the opening. Optionally, due to the difference in fluid flow rates, fluid may accumulate 84 in the cup insert. Optionally, the weight of the fluid in the cup insert may force 86 the flap into the closed configuration. Optionally, in the closed configuration, the flap may block 88 the opening, thereby stopping the flow of urine through the opening into the sample cup. Optionally, this mechanism may separate 90 the first urine portion from the second urine portion. Optionally, the sample cup may be sealed with a lid and / or cap for storage and / or transportation.

[0078] Fig. 9A is a schematic diagram illustrating cut-away views of a system for collecting urine, in accordance with some embodiments of the current invention. For example, the system may include a sample cup (not shown) and a cup insert 92a. Optionally, cup insert 92a may include an opening 94a located in the base thereof. Optionally, opening 94a may be small. Optionally, opening 94a may have a diameter and / or width range in size from 0. 1 mm to about 1.0 mm, and / or between about 1.0 mm to about 5.0 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm. Optionally, the small size of opening 94a may provide a good seal and / or easy activation by the urine flow. Optionally, opening 94a may be a hole. Optionally, opening 94a may include a funnel 96a. Optionally, funnel 96a may be narrow.

[0079] In some embodiments, cup insert 92a may include a flap 98a. Optionally, the flap may be located at the base of cup insert 92a. Optionally, flap 98a may be located within cup insert 92a in the vicinity of opening 94a. Optionally, flap 98a may be integral to cup insert 92a. Optionally, flap 98a and cup insert 92a may be a single molded piece. Optionally, flap 98a and cup insert 92a may be formed separately and / or assembled.

[0080] In some embodiments, flap 98a may be anchored above opening 94a. Optionally, flap 98a may be anchored below opening 94a. Optionally, flap 98a may be anchored adjacent to and / or within the funnel 96a. Optionally, flap 98a may be sealed against opening 94a. Optionally, flap 98a may be sealed against one or more sides of a funnel 96a. Optionally, flap 98a, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, flap 98a may include thinner tongue 100a. Optionally, thinner tongue 100a. For example, tongue 100a may connect between the cup insert 92a and flap 98a. Optionally, tongue 100a may be an integral joint. Optionally, flap 98a may rotate and / or bend about the integral joint. In some embodiments, the flap 98a includes a sealing structure. For example, part of flap 98a may fit into opening 94a while a protrusion 95a protrudes past an edge of opening 94a and / or seals against the floor of the cup insert 92a when flap 98a is closed. Additionally or alternatively, a wall of opening 94a may include a bevel 97a to seal up against a surface of the flap 98a. For example, the surface may be beveled to fit the bevel 97a of the opening.

[0081] Optionally, under the weight of accumulating urine, the integral joint may rotate and / or bend flap 98a, which may seal against the funnel 96a, preventing further flow from cup insert 92a through opening 94a into the sample cup. Optionally, the weight of fluid in cup insert 92a may close flap 98a. Optionally, the amount of fluid in cup insert 92a required to close flap 98a may depend on the thickness and / or flexibility of flap 98a and / or a thinner tongue 100a thereof.

[0082] Fig. 9B is a schematic diagram illustrating cut-away views of a system for collecting urine, in accordance with some embodiments. For example, the system may include a sample cup and a cup insert 92b. Optionally, cup insert 92b may include an opening 94b. For example, the opening may be located in the base of the insert 92b. Optionally, opening 94b may be small. Optionally, opening 94b may have a diameter and / or width range in size from 0. 1 mm to about 1.0 mm, and / or between about 1.0 mm to about 5.0 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm. Optionally, the small size of opening 94b may provide a good seal and / or easy activation by the urine flow. Optionally, opening 94b may be a hole. Optionally, opening 94b may include a funnel 96b. Optionally, funnel 96b may be narrow.

[0083] In some embodiments, opening 94b may include locking and / or sealing features. For example, sealing and / or locking elements may include a protrusion 95b that fits into a corresponding indentation 99b. For example, protrusion 95b may be on the flap 98b while indentation 99b is in the wall and / or funnel 96b. Optionally, cup insert 92b may include a flap 98b. For example, the protrusion 95b may seal to indentation 99b and / or a wall of opening 94b. Additionally or alternatively, flap 98b may latch to a wall of opening 94b. For example, there may be an interference element latching closed opening 94b. For example, closing opening 94b may include flexing of protrusion 95b with a beveled surface of indentation 99b and / or opening the opening 94b may require forcing the protrusion 95b against the bevel.

[0084] In some embodiments, the flap 98b may be located at the base of cup insert 92b and / or located within cup insert 92b (e.g., in the vicinity of opening 94b). Optionally, flap 98b may be integral to cup insert 92b. Alternatively or additionally, flap 98b and cup insert 92b may be formed separately and / or assembled.

[0085] In some embodiments, flap 98b may be anchored above opening 94b. Alternatively or additionally, flap 98b may be anchored below opening 94b and / or flap 98b may be anchored adjacent to and / or within the funnel 96b. In some embodiments, flap 98b may be sealed against opening 94b. Alternatively or additionally, flap 98b may be sealed against one or more sides of a funnel 96b. Optionally, flap 98b may include a flexible and / or elastic tongue 100b. Optionally, tongue 100b may be thinner than other parts of flap 98b and / or tongue 100b may connect flap 98b to insert 92b.

[0086] In some embodiments, under the weight of accumulating urine, a joint may rotate and / or flap 98b may bend, which may seal against the opening 94b, preventing further flow from cup insert 92b through opening 94b into the sample cup. Optionally, the weight of fluid in cup insert 92b may close flap 98b. Optionally, the amount of fluid in cup insert 92b required to close flap 98b may depend on the thickness and / or flexibility of flap 98b and / or tongue 100c.

[0087] Figs. 9C and 9D are schematic diagrams illustrating cut-away views of a system for collecting urine, in accordance with some embodiments. For example, the system may include a sample cup and a cup insert 92c. Optionally, cup insert 92c may include an opening 94c. For example, the opening may be located in the base of the insert 92c. Optionally, opening 94c may be small. Optionally, opening 94c may have a diameter and / or width range in size from 0. 1 mm to about 1.0 mm, and / or between about 1.0 mm to about 5.0 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm. Optionally, the small size of opening 94c may provide a good seal and / or easy activation by the urine flow. Optionally, opening 94c may be a hole. Optionally, opening 94c may include a funnel.

[0088] In some embodiments, opening 94c may include locking and / or sealing features. For example, sealing and / or locking elements may include a countersunk region 93c that fits into a corresponding flange (e.g., protrusion 95c). For example, protrusion 95c may be on the flap 98c while countersunk region 93c is optionally at an edge of opening 94c. For example, the protrusion 95c may seal to and / or countersunk region 93c and / or a wall of opening 94c. Additionally or alternatively, flap 98c may latch to a wall of opening 94c. For example, there may be an interference element latching closed opening 94c.

[0089] In some embodiments, the flap 98c may be located at the base of cup insert 92c and / or located within cup insert 92c (e.g., in the vicinity of opening 94b). Optionally, flap 98c may be integral to cup insert 92c. Alternatively or additionally, flap 98c and cup insert 92c may be formed separately and / or assembled.

[0090] In some embodiments, flap 98c may be anchored above opening 94c. Alternatively or additionally, flap 98c may be anchored below opening 94c and / or flap 98c may be anchored adjacent to and / or within the opening 94c. In some embodiments, flap 98c may be sealed against opening 94c. Alternatively or additionally, flap 98c may be sealed against one or more sides of an opening 94c. Optionally, flap 98c may include a flexible and / or elastic tongue 100c. Optionally, tongue 100c may be thinner than other parts of flap 98c and / or tongue 100c may connect flap 98c to insert 92c.

[0091] In some embodiments, under the weight of accumulating urine, a joint may rotate and / or flap 98c may bend, which may seal against the opening 94b, preventing further flow from cup insert 92c through opening 94c into the sample cup. Optionally, the weight of fluid in cup insert 92c may close flap 98c. Optionally, the amount of fluid in cup insert 92c required to close flap 98c may depend on the thickness and / or flexibility of flap 98c and / or tongue 100c.

[0092] Figs. 10A-H are schematic diagrams illustrating various views of a cup insert, in accordance with some embodiments. For example, the system may include a sample cup (not shown) and a cup insert 102. Optionally, cup insert 102 may include opening 104 located in the base thereof (e.g., Fig. 10B and Fig. 10C). Optionally, opening 104 may be small. Optionally, opening 104 may have a diameter and / or width range in size from 0.1 mm to about 1.0 mm, and / or between about 1.0 mm to about 5.0 mm, and / or between about 5.0 mm to about 10 mm, and / or between about 10 mm to about 15 mm, and / or between about 15 mm to about 30 mm. Optionally, the small size of opening 104 may provide a good seal and / or easy activation by the urine flow. Optionally, flap 106 may be located at the base of cup insert 102. Optionally, flap 106 may be located within cup insert 102 in the vicinity of opening 104. Optionally, flap 106 may be integral to cup insert 102. Optionally, flap 106 and cup insert 102 may be a single molded piece. Optionally, flap 106, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, flap 106 and cup insert 102 may be formed separately and / or assembled. Optionally, flap 106 may be anchored above opening 104 (e.g., Fig. 10D and Fig. 10F). Optionally, flap 106 may be anchored below opening 104 by one or more anchors 108. Optionally, flap 106 may be anchored 108 along one or more sides. Optionally, flap 106 may be connected on both sides by a thin integral joint. Optionally, flap 106 may include slits 110 along and / or adjacent to the unanchored sides. Optionally, flap 106 includes one or more slits 110 along and / or adjacent to at least one unanchored side of flap 106. Optionally, slits 110 may be configured to facilitate urine flow between the two sides of flap 106 and cup insert 102. Optionally, flap 106 may be sealed against opening 104. Optionally, when pressure is applied (e.g., by a flow of urine), flap 106 may bend towards the center, over opening 104, sealing slits 110 and preventing further flow of fluid though opening 104 (e.g., Fig. 10G and Fig. 10H are a side view and a bottom view, respectively, of a sealed opening). Optionally, slits 110 may have a concave shape. Optionally, slits 110 may have a shape that corresponds to the way flap 106 may bend (e.g., a parabolic shape), to create maximum sealing. Optionally, slits 110 which facilitate flow may be closed easily by applying pressure from the fluid from above, and / or rising from below. Optionally, a mechanism may be robust and / or may not be prone to failure and / or breakage.

[0093] Figs. 11A-D are schematic diagrams illustrating a system for collecting urine in open and closed configurations, respectively, in accordance with some embodiments. For example, flap 112 may be located at the base of cup insert 114. Optionally, flap 112 may be located within cup insert 114 in the vicinity of opening 116. Optionally, flap 112 may be integral to cup insert 114. Optionally, flap 112 and cup insert 114 may be a single molded piece. Optionally, flap 112, and / or a portion thereof, may be thin and / or flexible and / or elastic. Optionally, flap 112 and cup insert 114 may be formed separately and / or assembled. Optionally, flap 112 may be anchored above opening 116. Optionally, flap 112 may be anchored below opening 116 by one or more anchors (not shown). Optionally, flap 112 may be anchored along one or more sides. Optionally, flap 112 may be connected on both sides by a thin integral joint. Optionally, flap 112 may include slits (not shown) along and / or adjacent to the unanchored sides. Optionally, flap 112 includes one or more slits along and / or adjacent to at least one unanchored side of flap 112. Optionally, the slits may be configured to facilitate urine 118 flow between the two sides of flap 112 and cup insert 114. Optionally, flap 112 may be sealed against opening 116. Optionally, when pressure is applied (e.g., by a flow of urine 118), flap 112 may bend towards the center, over opening 116, sealing slits and preventing further flow of fluid though opening 116. Optionally, the slits may have a concave shape. Optionally, the slits may have a shape that corresponds to the way flap 112 may bend (e.g., a parabolic shape), to create maximum sealing. Optionally, the slits which facilitate flow may be closed easily by applying pressure from the fluid from above, and / or rising from below. Optionally, a mechanism may be robust and / or may not be prone to failure and / or breakage.

[0094] For example, urine 118 may flow through slits on either side of flap 112 to opening 116 in the base of cup insert 114. Optionally, the fluid flow rate into cup insert 114 may be much faster than the fluid flow rate out of opening 116 in the cup insert. Optionally, the fluid flow rate out of opening 116 may be controlled, at least in part, by the size and / or shape of the opening and / or the size and / or shape of the slits. As the volume of urine 118 accumulated within cup insert 114 increases, the pressure applied to flap 112 may increase, deforming the shape of flap 112 (e.g., a parabolic shape), gradually reducing the size of opening 116 and reducing the amount of urine 118 which may flow therethrough. Eventually, the pressure applied to flap 112 may be sufficient to seal flap 112 against opening 116, thereby stopping the flow of urine 118 out of cup inert 114 through the opening 116 into the sample cup. Optionally, this mechanism may separate the first urine 118 portion from the second urine 118 portion. Optionally, the sample cup may be sealed with a lid and / or cap for storage and / or transportation.

[0095] Figs. 12A-B are schematic diagrams illustrating a reverse actuation system for collecting urine, in accordance with some embodiments. For example, flap 124 may be located at the base of cup insert 122. Optionally, flap 124 may be located within cup insert 122 in the vicinity of opening 126. Optionally, flap 124 may be integral to cup insert 122. Optionally, flap 124 and cup insert 122 may be a single molded piece. Optionally, flap 124 and cup insert 122 may be formed separately and / or assembled. Optionally, flap 124 may be anchored below opening 126 by one or more anchors (not shown). Optionally, flap 124 may be biased downward and / or in the open configuration when the sample cup 120 and / or cup insert 122 is empty. Optionally, flap 124 may be composed of a flexible and / or elastic material. Optionally, flap 124 may be deformed by the pressure and / or weight and / or volume of the fluid 128. Optionally, deformation of flap 124 may, at least in part, seal opening 126. Optionally, slits which facilitate flow may be closed by application of pressure by the fluid 128 from below. Optionally, in a closed configuration, flap 124 may prevent passage of fluid 128 through opening 126. Optionally, the fluid in the sample cup 120 may push flap 124 upwards into the closed configuration. Optionally, when the fluid 128 in sample cup 120 reaches a threshold volume and / or height the fluid may push flap 124 from the open configuration to a closed configuration.

[0096] Figs. 13A-H: Schematic diagrams illustrating a system for collecting urine, in accordance with some embodiments. For example, the system may include a sample cup 130, a first urine catcher 132 including a rotating flapl34 with a pivot 136. Optionally, the first urine catcher may be part of a cup insert 131 (e.g., that may be inserted into an existing or custom sample cup 130. For example, the insert 131 may be attached to a wall of a sample cup 130. Alternatively or additionally the catcher 132 may be intrinsic to the sample cup. The flap 134 may include a container 138. The first urine portion 140 may flow into the container 138. Optionally, the weight and / or pressure of the urine may cause flap 134 to rotate. In some embodiments, catcher 132 may include an empty space that holds the first flow urine. Alternatively or additionally, first urine portion 140 may be absorbed by an absorbent material located within the catcher 132. In some embodiments, the weight of the urine and / or saturated and / or partially saturated absorbent material may cause flap 134 to rotate. Optionally, upon completing its rotation, flap 134 may close and / or seal catcher 132. Optionally, closing flap 134 separates first urine portion 140 within catcher 132. Second urine portion 142 may then flow into sample cup 130 for sampling.

[0097] According to some embodiments, the flap may include a hinge and / or pivot. Optionally, the flap may include be configured to rotate about an axis due to the pressure and / or weight of the urine. Optionally, the flap may be configured to prevent passage of a first urine portion. Optionally, the flap may include a container 138 configured to catch a first portion of urine. For example, when flap 134 closes the first portion of the urine in the container 138 may be dumped into catcher 132. Alternatively or additionally, the flap and / or the container 138 may include absorbent material. Optionally, the weight of the urine and / or the heavily saturated absorbent material may rotate the flap about an axis. Optionally, rotation of the flap may direct a first urine portion into a cup insert. Optionally, rotation of the flap may drive the flap from an open configuration to a closed configuration. Optionally, the flap may close and / or seal the cup insert once the flap has completed its rotational arc. Optionally, in the closed configuration, the rotated flap may trap a first urine portion. Optionally, in the closed configuration, the rotated flap may facilitate passage of a second urine portion into the sample cup. in the closed configuration, the rotated flap may facilitate separation of the first urine portion and the second urine portion. Optionally, in the closed configuration, the rotated flap may prevent contamination of the second urine portion.

[0098] Figs. 14A-C are schematic diagrams illustrating collection of urine, in accordance with some embodiments. For example, after urination is complete, a sample of the second urine portion may be obtained from the system. Optionally, there may be an opening and / or port 146 with a seal at the bottom of the sample cup 144 and / or cup insert 152 configured for extraction of the urine sample. Optionally, the lid 150 may include an opening and / or port 146 with a seal configured for extraction of urine from sample cup 144 and / or cup insert 152. Optionally, the seal may be sterile. Optionally, the port may be configured for sterile aspiration of urine. Optionally, vacuum syringe 148 may be inserted into the port. Optionally, vacuum syringe 148 may include a needle. Optionally, the needle may pierce the seal and the vacuum may draw the second portion of urine into the sterile syringe for testing. Optionally, sample cup 144 and / or cup insert 152 may include an absorbent material configured for absorption of the first urine sample and / or the second urine sample to prevent spillage and / or remixing and / or contamination. Optionally, the urine saturated absorbent material may be extracted for testing.

[0099] Fig. 15 is a block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention. For example, system 154 may be configured for collection and separation of midstream urine. System 154 may include a sample cup 156 configured to collect a first urine portion, and a separator 158, For example, separator 158 may be part of the sample cup 156 and / or an insert that can be placed into an independent cup. For example, separator 158 is mounted within the sample cup 156, and wherein said cup 156 is configured to collect a midstream urine portion. Alternatively or additionally, the separator 158 may collect the midstream portion and the first stream portion may be collected in the cup.

[0100] In some embodiments, the device for separating first flow urine from mid-flow urine in a sample cup 156 includes a sample cup 156 and a separator 158. The sample cup 156 is designed to collect urine samples, while the separator 158 is configured to differentiate between the initial stream of urine, which may contain contaminants, and the subsequent midstream urine, which is typically cleaner and more suitable for testing . The separator 158 can either be an independent insert placed within the sample cup 156 or an integral part of the cup 156 itself.

[0101] The separator 158 may include an absorbent material positioned within the sample cup 156. This absorbent material is designed to rapidly absorb the first portion of urine, thereby inhibiting its passage into the main collection area of the sample cup 156. The absorbent material may be composed of a hydrophilic polymer that forms a hydrogel upon absorbing urine. Examples of suitable absorbent materials include Polyacrylic Acid (PAA), Polyvinyl Alcohol (PVA), Carboxymethyl Cellulose (CMC), and others. This hydrogel formation helps trap the initial stream of urine, preventing it from mixing with the midstream urine.

[0102] Optionally, the absorbent material may be configured in multiple layers, each designed to absorb different contaminants or microorganisms. The top layer may filter out larger particles and contaminants, while lower layers may be configured to absorb specific microorganisms or chemical compounds. This layered structure can facilitate targeted laboratory testing of the absorbed urine, such as chemical or biological testing. Additionally, the absorbent material may include growth media to culture microorganisms from the midstream urine, ensuring that only the desired portion of the urine sample is tested.

[0103] Alternatively or additionally, the separator 158 may include a mechanical means of separating urine portions, such as an elastic flap or a valve. This mechanical separation mechanism can be configured to open and close based on the weight and pressure of the urine flow. For example, an elastic flap may remain open to allow the first portion of urine to pass through and then close to trap the midstream urine in the sample cup 156. This mechanical separation, combined with the absorbent material, ensures that the first flow urine is effectively separated from the mid-flow urine, facilitating accurate and uncontaminated urine sample collection fortesting.

[0104] Fig. 16 is a flow chart illustrating a method for use of the system for collecting and / or separating 168 urine. In accordance with some embodiments of the invention, a method 160 for separating 168 first flow urine from mid-flow urine in a sample cup is disclosed. The method begins by initiating urination 162. Optionally, the first portion of urine is trapped 164 in a catcher and / or a cup insert and / or an absorbent material.

[0105] In some embodiments, cup insert may include an absorbent material configured to rapidly absorb the first portion of urine, thereby inhibiting its escape and preventing contamination of the subsequent urine flow. The absorbent material may be designed to absorb any first stream contaminants along with the first portion of the urine, ensuring that the midstream urine remains uncontaminated as it passes over the saturated particles.

[0106] Following the trapping 164 of the first portion of urine, the second portion of urine is allowed to pass 166 into the sample cup. This is facilitated by the saturation capacity of the absorbent material, which, once reached, enables the second portion of urine to flow between the particles of the absorbent material into the sample cup. Alternatively or additionally, the absorbent material may be configured to prevent the passage of the second portion of urine into the sample cup by forming a hydrogel that traps the second portion above the hydrogel layer within the cup insert. This method effectively separates 168 the first urine portion from the second urine portion for subsequent analysis.

[0107] In some embodiments, the system may include multiple layers of absorbent materials within the cup insert, each configured to absorb different organisms and / or compounds. For example, a top layer may filter out particles and contaminants not of interest, while lower layers may be designed to absorb specific microorganisms or chemical compounds. This layered approach allows for the selective absorption and separation 168 of various urine portions, facilitating targeted laboratory testing, such as chemical or biological testing, including culture testing. The absorbent material may also include growth media to culture microorganisms from the midstream urine, ensuring that only the desired urine portion undergoes laboratory analysis.

[0108] Additionally or alternatively, the system may incorporate a mechanical means of separating 168 urine portions, such as a flap or valve mechanism. For instance, a flap located at the base of the cup insert may be configured to close upon reaching a certain urine volume, thereby trapping 164 the first urine portion and allowing the second portion to pass into the sample cup. This mechanical separation 168 may be combined with the absorbent material to enhance the separation 168 process and prevent contamination. The system may also include features such as a lid or cap for secure storage and transportation of the urine sample, ensuring that the separated 168 urine portions remain uncontaminated and ready for analysis.

[0109] Additionally, or alternatively, urination may be initiated. A first urine portion may pass into the sample cup. A second urine portion may be trapped in the cup insert of a sample cup. The first urine portion may thereby be separated from the second urine portion for analysis.

[0110] Figs. 17A-C are schematic diagrams illustrating systems for collecting and separating urine, in accordance with some embodiments of the invention. For example, the system may include an absorbent material 172. Optionally, the absorbent material may include a plurality of absorbent particles. Optionally, the absorbent material may be configured to absorb urine. Optionally, the absorbent material may be a hydrophilic polymer. Optionally, the absorbent material may form a hydrogel on absorption of urine. Non-limiting examples of absent materials include: Polyacrylic Acid (PAA), Polyvinyl Alcohol (PVA), Carboxymethyl Cellulose (CMC), Hydroxyethyl Cellulose (HEC), Polyethylene Glycol (PEG), Polyacrylamide (PAM), Alginate, Agarose, Gelatin, Starch, Cellulose, Chitosan, Dextran, or combinations thereof. Optionally, the absorbent material may be configured to absorb any first stream contaminants along with the first portion of the urine. Optionally, the absorbent material may be configured avoid contamination as midstream passes over saturated particles. Optionally, the saturation capacity of the absorbent material may facilitate absorption of the first portion of urine without absorbing the second portion of urine.

[0111] According to some embodiments, the absorbent material may be configured to preferentially absorb various microorganisms and / or chemical compounds. Optionally, the absorbed portion of the urine may undergo laboratory testing, e.g., chemical testing, biological testing such as culture testing, etc. Optionally, the absorbent material may include one or more layers of absorbent materials. Optionally, each layer of absorbent material may be configured to absorb a different organism and / or compound. Optionally, the various layers may be configured to filter various sizes of particles and / or contaminants and / or compounds. Optionally, each layer may be configured to absorb a different urine portion. Optionally, the layer with the desired urine portion may undergo laboratory testing. Optionally, a top layer may be configured to filter particles and contaminants that are not of interest, while lower layers may be configured to filter particles and contaminants that are of interest, or vice versa. Optionally, atop layer may not facilitate growth of microorganisms, while lower layers may include growth media to culture microorganisms from midstream urine, or vice versa. Optionally, the absorbent material may include and / or may be growth media. Optionally, the growth media may be configured to culture colonies of microorganism.

[0112] Cup insert 174 may include an absorbent material 172. Optionally, the absorbent material may be configured to rapidly absorb the first portion of urine, so that it does not escape. Optionally, the absorbent material 172 may be configured to absorb a first portion of urine 170. Optionally, the absorbent material may be configured to facilitate passage of a second portion of the urine 178 of urine into the sample cup, e.g., once the saturation capacity of the absorbent material has been reached, the second portion of urine may pass between particles of the absorbent material into the sample cup 176. Optionally, the absorbent material 172 may be configured to prevent passage of a second portion of urine into the sample cup 176, e.g., the absorbent material 172 may absorb a first portion of urine to become a hydrogel, preventing passage of a second portion of urine 178, trapping the second portion of urine 178 above hydrogel layer in the cup insert 174. Optionally, a first portion of urine and a second portion of urine may be separated by absorption of a first portion of urine by an absorbent material. Optionally, there may be a separation layer and / or a membrane separating the absorption layer from the collected urine e.g., to prevent recontamination.

[0113] Alternatively or additionally, an absorbent material 172 may be placed in sample cup and absorb and / or separate the first stream urine. For example, the absorbent material 172 may be in the top and / or bottom and / or middle of the cup. Fig. 18 is a block diagram illustrating a system for collecting and separating urine, in accordance with some embodiments of the invention. For example, system 180 may be configured for collection and separation of midstream urine. System 180 may include a sample cup 182 configured to collect a first urine portion, and a cup insert 184, wherein the cup insert 184 is mounted within the sample cup 182, and wherein said cup insert 184 is configured to collect a second urine portion. Sample cup 182 and / or cup insert 184 may include an absorbent material 186 configured to absorb the first urine portion and / or the second urine portion.

[0114] In some embodiments, the sample cup 176 may include an absorbent material 172 integrated into the wall of the cup and / or lining the walls of the cup (e.g., as illustrated in Fig. 17C). In some embodiments an absorbent insert may be placed in the cup. The insert may have any shape, for example, it may be a cup shaped liner fitting into the urine cup and / or a pillar shape etc. This absorbent material 172 is configured to absorb the first portion of urine, thereby inhibiting the contamination of the second portion of urine 178. The absorbent material 172 may include a variety of hydrophilic polymers. These materials facilitate the rapid absorption of the first portion of urine and / or form a hydrogel that traps contaminants and inhibits their passage into the second portion of urine 178. Some embodiments, may include absorbent material in multiple locations (the sides of the cup, the bottom of the cup and / or a funnel at the top of the cup.

[0115] Fig. 19 is a flow chart illustrating a method for use of the system for collecting and separating urine, in accordance with some embodiments of the invention. For example, in method 190, urination may be initiated 192. A first portion of urine passes into the cup insert, and is absorbed 194 by absorbent particles of an absorbent material. A second portion of urine passes 196 through the absorbent particles into the sample cup. The first urine portion may thereby be separated 198 from the second urine portion for analysis.

[0116] Additionally, or alternatively, urination may be initiated. A first urine portion may pass into the sample cup. A second urine portion may be trapped in the cup insert of a sample cup. The first urine portion may thereby be separated from the second urine portion for analysis. Sample cup and / or cup insert may include an absorbent material configured to absorb the first urine portion and / or the second urine portion. These embodiments are provided by way of example and are in no means intended to limit the scope of the invention.

[0117] While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination and arrangement of parts, may be made without departing from the spirit and scope of the invention.

[0118] GENERAL

[0119] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0120] As used herein the term “about” refers to ± 10%

[0121] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

[0122] The term “consisting of’ means “including and limited to”.

[0123] The term "consisting essentially of' means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0124] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

[0125] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0126] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0127] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0128] It is expected that during the life of a patent maturing from this application many relevant building technologies, artificial intelligence methodologies, computer user interfaces, image capture devices will be developed and the scope of the terms for design elements, analysis routines, user devices is intended to include all such new technologies a priori.

[0129] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0130] All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

CLAIMSWhat is claimed is:

1. A system for collection and separation of midstream urine comprising: a sample cup with a lid configured to collect a first urine portion; and a cup insert, wherein the cup insert is mounted within the sample cup, and wherein said cup insert is configured to collect a second urine portion.

2. The system according to claim 1, wherein the cup insert includes an opening and a flap located on a base of said cup insert, and wherein the flap is configured to seal the opening on accumulation of urine within said cup insert.

3. The system according to claim 2, wherein the cup insert is fitted within the sample cup by a connector.

4. The system according to claim 2, wherein the cup insert is integral to the sample cup.

5. The system according to claim 2, wherein the lid is selected from a threaded cap, screw -on lid, snap-on lid, press-and-seal lid, ribbed lid, or a child-proof lid.

6. The system according to claim 2, wherein the opening is configured for a slower fluid flow rate than an average rate of urination.

7. The system according to claim 2, wherein a fluid flow rate out of the opening is controlled, at least in part, by a size and shape of the opening.

8. The system according to claim 2, wherein the opening has a diameter ranging between about 0.1 mm to about 5 mm.

9. The system according to claim 2, wherein the opening includes a funnel.

10. The system according to claim 2, wherein the flap is integral to the cup insert.

11. The system according to claim 2, wherein the flap is anchored to the cup insert along at least one side.

12. The system according to claim 11, wherein the flap is anchored above the opening, below the opening, adjacent to the opening, or within the opening or a component thereof.

13. The system according to claim 2, wherein the flap is configured to deform, bend or rotate under a weight or pressure of the urine accumulated in the cup insert.

14. The system according to claim 2, wherein the flap includes a thinner portion configured to bend or rotate.

15. The system according to claim 2, wherein the flap includes one or more slits along or adjacent to at least one unanchored side of said flap.

16. The system according to claim 15, wherein the slits are configured to facilitate passage of urine.

17. The system according to claim 15, wherein the slits have a concave shape.

18. The system according to claim 15, wherein the slits are configured to be closed by a weight or pressure of the urine accumulated in the cup insert.

19. A method collection and separation of midstream urine, the method comprising: initiating urination; passing a first portion of urine into a cup insert, and then through an opening past a flap in an open configuration and into a sample cup; accumulating said first urine portion in the sample cup; accumulating a second urine portion in the cup insert due to a difference in fluid flow rates between a flow rate of urine entering the cup insert and a flow rate of urine flowing out of the cup insert through the opening; and converting said flap from an open configuration to a closed configuration by a weight of the urine in the cup insert, thereby sealing the opening and inhibiting further flow through said opening.

20. The method according to claim 19, further comprising configuring said opening for a slower fluid flow rate than an average rate of urination.

21. The method according to claim 19, further comprising controlling the fluid flow rate out of the opening, at least in part, by a size and shape of the opening.

22. The method according to claim 19, wherein said converting the flap from an open configuration to a closed configuration is through rotating said flap about an integral joint.

23. The method according to claim 19, wherein said converting the flap from an open configuration to a closed configuration is through bending or deforming said flap.

24. The method according to claim 19, further comprising passing the first portion of urine into the sample cup through a funnel in the opening.

25. The method according to claim 19, further comprising passing the first portion of urine into the sample cup through one or more slits located along or adjacent to at least one unanchored side of the flap.

26. The method according to claim 19, further comprising sealing the sample cup with a lid for storage and transportation.

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