Capillary Slit Urine Sampling System

We disclose a device and method for collecting a urine sample as a user urinates into a toilet. The device further conducts analytical measurements which may include spectral, colorimetric, and chemical assays. The user need only urinate normally into the toilet. A urine collection trap, which includes a vertical slit, may capture a urine sample which has a volume in the microliter range. Pumps may divert the urine from the vertical slit into a conduit that is connected to spectral analysis devices and other devices for analyzing the urine sample. The disclosed device is both convenient and prevents unsanitary urine spills.

BACKGROUND

Field of the Invention

This invention relates to devices for collecting and analyzing urine and methods of use thereof.

Background of the Invention

Collecting a urine sample for analysis is often inconvenient. Urine collection often involves urinating into a receptacle and may result in unsanitary urine spills and drips. Some types of urinalysis require a user to urinate on a test strip or a specific part of a device. Controlling the urine stream to contact only a test strip or part of a device is often difficult and results in urine splashing onto unwanted areas. A device and method of collecting a urine sample that is easy and without risk of urine spills or drips is needed.

In addition, many types of urinalysis assays are not adapted for use outside the clinic setting. Consequently, a device and method of performing complex analysis of urine samples in the home or elsewhere outside of the clinic setting is needed.

SUMMARY

We disclose a novel system for collecting and analyzing urine samples. The urine sampling system may be located within a toilet bowl. The urine sampling system may include an elongated, elevated mound that may be flush with the wall of the toilet bowl. A vertical slit may bisect the mound with the slit running substantially parallel with the longitudinal axis of the mound. A user urinates normally into the toilet bowl and the urine stream flows over the mound. The mound acts as a dam to channel urine into the vertical slit. The vertical slit captures a urine sample by capillary action.

The urine sampling system may include a conduit that is in fluid connection with the vertical slit and may include a pump that, when actuated, moves the urine sample from the vertical slit into the conduit through a sample port. The conduit may be in fluid connection with one or more analytical devices which may conduct analytical assays on the urine sample. These assays may include, but are not limited to, chemical, spectral, and colorimetric assays.

The urine sampling system may include a junction along the conduit that includes a spectral analysis cell. The spectral analysis cell may include two substantially parallel light-transmitting plates. The urine may move from the conduit into the space between the light-transmitting plates. A light source may emit light through a filter which then allows light of one or more defined wavelengths to pass through the filter and through the urine sample in the spectral analysis cell. A spectrometer may then perform a spectral measurement on the light transmitted through the spectral analysis cell. In some embodiments, the urine sampling system may store the urine sample after analysis for additional testing.

The urine may continue through the conduit after passing through the junction to either exit the urine sampling system or be transferred into additional medical devices for further analysis. In some embodiments, the urine exits the conduit through a port that is different than the sample port and in some embodiments the pump reverses the direction of urine travel sending it out through the sample port.

Upon exiting the urine sampling system, the urine may be dispensed into the toilet water and flushed. The urine sampling system may draw rinse water through the system between uses. Urine flows around the mound, rather than pooling, so that there is little or no residual urine remaining on the mound. Rinse water from the lip of the toilet bowl that may be dispensed upon flushing the toilet or water from a sprayer may rinse the mound between uses.

The disclosed urine sampling system collects a urine sample while the user simply urinates into a toilet bowl thus providing a convenient and sanitary method to collect urine for analysis. The urine sampling system may then perform one or more analysis on the sample which may be used to assess the user's health status or diagnose illness. The analysis may be done in the home or elsewhere outside of a clinical setting. The disclosed urine sampling system provides convenient health services without the need to visit a clinic.

DETAILED DESCRIPTION

Definitions

User, as used herein, means a human or animal that deposits bodily waste into an embodiment of the toilet disclosed herein.

Toilet, as used herein, means a device that may be used to collect one or more biological waste products of a user.

While this invention is susceptible of embodiment in many different forms, there are shown in the drawings, which will herein be described in detail, several specific embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principals of the invention and is not intended to limit the invention to the illustrated embodiments.

Disclosed herein is a urine sampling system which comprises a device which captures a urine sample as a user urinates into a toilet. Upon capturing the urine sample, the device may transfer the urine sample into one or more analytical devices which may conduct one or more chemical, colorimetric, or spectral analysis on the urine sample. The measurements collected from the analytical devices may be used to provide an assessment of the user's health or provide a diagnosis. In some embodiments, the urine sampling system then captures a sample of water to rinse the system between uses.

Parts of the disclosed urine sampling system may be positioned within the toilet bowl of a toilet. In some embodiments, the urine sampling system includes a structure that resembles an elongated mound that may be an elevated region of the wall of the toilet bowl. The mound may be formed from two separate sections separated by a vertical slit. The mound may include a longitudinal and transverse axis, the longitudinal axis being greater in length than the transverse axis. The vertical slit may run substantially parallel to the transverse axis and may approximately bisect the mound between the two sections. In some embodiments, the longitudinal axis of the mound is parallel to an axis of the toilet bowl that runs left to right across the toilet bowl from the perspective of a user sitting on the toilet seat.

The mound may be positioned above the standing water level set by the toilet's P-trap. Furthermore, the mound may be located near the front of the toilet bowl. As used herein, the front of the toilet bowl is the side of the toilet bowl where a user may stand as he or she approaches the toilet bowl. The front is opposite a rear side of the toilet bowl which is near the opening which leads to the P-trap in a traditional toilet. Consequently, the user's urine stream flows onto the mound whether the user is standing in front of the toilet or sitting on the toilet seat.

The mound functions much like a dam by temporarily detaining urine as it flows over the mound and channeling a urine sample into the vertical slit. In some embodiments, the vertical slit collects approximately between 10 μl of urine to approximately 50 μl of urine. In some embodiments, the vertical slit collects approximately 25 μl of urine. The width of the vertical slit may be small enough that capillary forces hold urine in the vertical slit even after urination has stopped. However, the urine does not pool on the mound so rinse water from the lip of the bowl or a sprayer may rinse the residual urine from the mound and may provide rinse water that enters the urine sampling system through the vertical slit as discussed in more detail below. Consequently, the urine sampling system may be rinsed when the user flushes the toilet.

In some embodiments, the urine sampling system includes a vertical slit but does not include a mound. In these embodiments, the slit is positioned substantially flush with the wall of the toilet bowl. A user's urine stream may pass over the vertical slit. The vertical slit may pull a urine sample into the vertical by capillary action. The vertical slit may be substantially perpendicular to a front-to rear axis of the toilet bowl, substantially parallel to the front-to-rear direction axis of the toilet bowl, or positioned at an angle between parallel and perpendicular to the front-to-rear direction axis of the toilet bowl. “Front-to rear direction axis” as used herein, is illustrated as front-to-rear direction axis130shown inFIG. 1. “Front” is the side of the toilet bowl that is nearest where a user approaching the toilet would stand and “rear” is the side along front-to-rear direction axis130that is nearest the toilet tank of a traditional toilet.

In some embodiments in which the vertical slit is positioned substantially flush with the wall of the toilet bowl, the toilet bowl may include a depression in a wall of the toilet bowl. The vertical slit may be located within the depression. Urine may flow down into the depression and into the vertical slit. The vertical slit may then pull a urine sample into the vertical by capillary action.

In some embodiments in which the vertical slit is positioned substantially flush with the wall of the toilet bowl, the wall of the toilet bowl may include an elongated channel. The elongated channel may trap urine and direct the urine toward the vertical slit.

In some embodiments, the urine sampling system includes one or more sensors which detect the presence of urine. The sensors may include a temperature sensor, an optical sensor, or both. In some embodiments, a level sensor or flow meter is present in the toilet bowl or P-trap which detects when volume has been added to the toilet bowl. A gas sensor may be used in conjunction with the level sensor or flow meter to detect volatile organic compounds emitted from feces. Thus, the sensors may distinguish between defecation and urination events.

Some embodiments include sensors which may detect the presence of a user on or near the toilet. These sensors may include optical proximity sensors and weight sensors. In addition, weigh sensors may detect that the user is urinating by detecting a loss of weight after an initial body weight measurement. The weight sensor may also be combined with a gas sensor to differentiate weight lost due to urination versus defecation.

A sampling port may be positioned either at the bottom or a side of the vertical slit. The sample port may connect the vertical slit with a conduit. The conduit may resemble a section of tubing or a pipe. Some embodiments include an inlet valve between the sample port and the conduit which regulates fluid entry into the system and fluid exit from the system. The inlet valve may be connected to a controller which may actuate the valve to open and close the valve.

In some embodiments, the conduit is connected to a T-junction which includes three ports. The sample port may comprise a first port of the T-junction. A second port of the T-junction may be connected to a pump which, when actuated, may create force which pulls urine from the vertical slit, through the sample port, and into the conduit. A hose or similar tubing may connect the pump to the conduit. A third port of the T-junction may be an output port through which urine exits the urine sampling system after analysis. Some embodiments include an output valve which may open to allow fluid to exit the urine sampling system after urinalysis but which may close during and prior to urine analysis.

The pump that is present in embodiments that include a T-junction may be a syringe pump. In embodiments which include check valves, the action of the syringe pump may open and close the valves without the need for a signal from the controller.

The syringe pump may draw a urine sample into the conduit from the vertical slit. The pump may draw the entire capillary volume, after which the pump will draw air. This creates a narrow bubble of urine with an inner diameter of approximately between 1/32 inch and approximately 1/16 inch. This allows for a smaller syringe pump volume which may make dispensing small volumes easier. In embodiments in which the output valve is closed at this point in the process, the bubble may be drawing through the second port of the T-junction towards the syringe pump. We point out that some embodiments do not create a narrow bubble of urine. Embodiments which create a narrow bubble of urine simply do so to enable a smaller syringe pump volume.

Alternatively, other embodiments may not include a T-junction. Rather, some embodiments may include a linear fluid path which may include a conduit and a peristaltic pump which pushes fluid through the conduit. In embodiments that include a linear fluid path with no T-junction, fluid may enter the sample port and travel through the conduit then exit through the outlet port. In these embodiments, the peristaltic pump pushes fluid through the conduit in a single direction.

In other embodiments, a single port functions as both the sample port and output port. The urine sample may travel from the vertical slit through the single port and into the conduit where it is analyzed. A peristaltic pump may function in a first direction to force the urine from the vertical slit toward the conduit. After analysis is complete, the peristatic pump may function in a second direction to force urine from the conduit and back through the single port and out through the vertical slit.

In embodiments that include a T-junction, a syringe pump may pull fluid into the conduit through the single port when the plunger is withdrawn from the barrel of the syringe pump. After analysis, the plunger may re-enter the barrel of the syringe pump creating a force which pushes the fluid back through the conduit in the opposite direction the urine traveled during entry, through the single port, and out through the vertical slit.

In embodiments that include a single port that functions as both a sample port and output port, valves to regulate fluid entry into and exit from the conduit are optional. In embodiments that include a single sample/outlet port, a valve may optionally be included to prevent entry of foreign substances into the system during urinalysis. The valve may be a solenoid driven pinch valve or other actuated valve.

Upon entering the conduit, the urine may travel to a junction which may be positioned along the conduit. The junction may include a spectral analysis cell which may house urine while the urine sampling system conducts optical measurements. The optical measurements may detect one or more of color, light transmission, and particle size. The measurement may be performed by microscopy, laser light scattering, turbidity measurements, spectroscopy, or other techniques known in the art.

In some embodiments, the spectral analysis cell may include two light-transmitting plates which may be positioned substantially parallel to each other. A width of a space between the two light-transmitting plates may be small enough that the urine may spread substantially evenly along the faces of the plates by capillary force. The width of the space between the two light-transmitting plates may be adjustable so as to adjust the distance of the light transmission path through the urine sample. In some embodiments, a variable diaphragm, which may be a liquid lens, may be used to control the length of the light transmission path thereby controlling the spectral measurements. Some embodiments include a compliant seal, which may be an O-ring, between the two light-transmitting plates. The compliant seal may contain the urine sample keeping it within a light transmission section through which light emitted from a light source may travel during spectral analysis. In some embodiments, an entrance port transverses one of the light-transmitting plates. The urine sample may travel from the conduit into the spectral analysis cell through the entrance port. The urine may exit the spectral analysis cell through an exit port that may transverse the second light-transmitting plate. Both the entrance port and the exit port may be in fluid connection with the conduit through sections of tubing or pipe.

Spectral analysis may also be conducted through tubing that comprises one or more sections of the conduit. The cross-sectional diameter of the tubing may vary along the length of the tubing. Spectral measurements may be collected from sections of tubing with different diameters to collect measurements from regions of tubing that have different levels of absorption.

Embodiments which include a microfluidic system for spectral analysis that is located below the mound and vertical slit may have an advantage over conducting the spectral analysis in the vertical slit. These may include additional protection from ambient light. In addition, it may be easier to regulate the temperature within the microfluidic system below the vertical slit. This is at least because urine in the vertical slit may evaporate, lose heat, and may absorb heat from the toilet bowl.

In some embodiments, the third port of a T-junction or yet another port may connect the conduit with a reservoir housing a reagent which may be added to the urine sample within the spectral analysis cell to conduct a chemical or colorimetric assay.

In addition to spectral analysis, the conduit may be connected to other devices which may conduct urinalysis assays. In some embodiments, the urine is expelled through an output port and into a reagent, or test strip for further analysis. In some embodiments, the urine exits the output port and is dispensed into a multi-well plate for further chemical analysis. The output port may dispense the urine through a volume controlled system known in the art which may include an automated micropipette.

In some embodiments, the urine may be dispensed into a collector for further examination or to maintain as evidence. This step may be performed when an analytical test indicates a potential health concern while non-suspect samples may be ejected out through the vertical slit or a separate output port.

Referring now to the drawings,FIG. 1illustrates toilet100which includes an embodiment of the disclosed urine sampling system. Toilet100includes rim140which is connected to proximity sensor160. In some embodiments, proximity sensor160, or embodiments thereof, detect the presence of a user and send a signal to a controller which then prepares the urine sampling system to receive a urine sample.

Toilet100further includes toilet bowl110and orifice150which leads to the P-trap within toilet100. Urine collection trap120is shown within toilet bowl110. Urine collection trap120is positioned above the toilet water line and nearer the front of rim140than the rear of rim140. In this embodiment, urine collection trap120is between the front of rim140and orifice150. Arrow130, shown inFIG. 1, illustrates the front-to-rear direction axis of toilet bowl110. “Front,” as used herein, is the side along front-to-rear direction axis130that is nearest where a user approaching the toilet would stand and “rear” is the side along front-to-rear direction axis130that is nearest the toilet tank of a traditional toilet. The toilet bowl may also comprise a width axis which is perpendicular to the front-to-rear axis.

FIG. 2is a close-up view of urine sampling system200which includes urine collection trap120. Arrow250illustrates longitudinal axis of urine collection trap120and arrow260illustrates a transverse axis of urine collection trap120. As described above with regard toFIG. 1, urine collection trap120is shown within toilet bowl110above the toilet water. Urine collection trap120resembles a mound which includes first section210and second section220. The mound is elongated with the longer axis substantially parallel with longitudinal axis250and the shorter axis substantially parallel with transverse axis260. An opening between first section210and second section220defines an orifice referred to herein as vertical slit230. The orifice of vertical slit230transects the mound and is substantially parallel to front-to-rear direction axis130of the toilet bowl and to transverse axis260of urine collection trap120. Vertical slit230is sufficiently narrow such that it captures urine and diverts it down into the orifice of vertical slit230by capillary action.

FIG. 3is an aerial view of toilet300which includes an embodiment of the urine sampling system. Urine collection trap120is again illustrated nearer the front of the toilet bowl than orifice150and near the front of the toilet rim, with as defined by front-to-rear direction axis130. In this embodiment, vertical slit230is substantially parallel to front-to-rear direction axis130.

FIG. 4is a cross-sectional view of toilet400which includes an embodiment of the disclosed urine sampling system. Toilet water450is shown within toilet bowl110. Urine collection trap120is positioned within toilet bowl110above toilet water450. Urine collection trap120is connected to conduit410which, in this embodiment, is located below toilet bowl110. Urine collected by urine collection trap120is transferred through the vertical slit and into conduit410. Conduit410is further connected to chemical analysis assay devices430and440. Each of chemical analysis assay devices430and440may conduct a urine analysis assay on the urine sample.

FIG. 5is a schematic cross-sectional view of urine sampling system500, which is an embodiment of the disclosed urine sampling system. Urine collection trap120is shown as a cross section of a mound with vertical slit230bisecting it. The mound configuration of urine collection trap120acts as a dam to trap urine as it flows into the toilet bowl. Urine pools against the mound as a dam inhibits water flow. The mound detains the urine long enough for some of the urine to enter vertical slit230but the remaining urine flows around the mound and into the toilet bowl so that there is no standing urine on urine collection trap120. Capillary action pulls the urine sample from the upper opening of vertical slit230down into vertical slit230. Conduit520is in fluid connection with vertical slit230through sample port510. Urine sampling system500includes inlet valve540and output valve540. Urine sensor595may detect the presence of urine and send a signal to controller590. Controller590may then send a signal which causes inlet valve540to open and output valve550to close. Controller590may also send a signal to actuate peristaltic pump515which draws the urine sample from vertical slit230through sample port510and into conduit520. The downward-pointing arrow indicates the direction of urine travel. As the urine travels through conduit520, the urine enters a junction. In urine sampling system500, the junction includes spectral analysis cell560. An embodiment of a spectral analysis cell is shown in more detail inFIGS. 7A, 7B, and 8. Spectral analysis cell560includes light transmission section570through which filtered light may pass during spectral analysis. After spectral analysis is complete, controller590sends a signal to open output valve540and to actuate peristaltic pump515. The urine sample moves out of spectral analysis cell560, continues through conduit520, and out of urine sampling system500through output port530. In some embodiments, the process is repeated with rinse water between uses. In some embodiments, the rinse water may be toilet water.

FIG. 6is a schematic cross-sectional view of urine sampling system600, which is another embodiment of the disclosed urine sampling system. Urine sampling system600is structurally and functionally similar to urine sampling system500except that peristaltic pump515of urine sampling system500has been replaced with syringe pump690. A signal from controller590causes syringe pump690to actuate and the plunger of syringe pump690pulls away from the syringe barrel in the direction shown by the horizontal arrow inFIG. 6. Similar to peristaltic pump515, syringe pump690pulls the urine sample from vertical slit230through sample port510and into conduit520in the direction shown by the downward-pointing arrow.

FIG. 7Ais a cross sectional side view of an embodiment of a spectral analysis cell that may house a urine sample during spectral analysis and which may be included in the disclosed urine sampling system. The spectral analysis cell ofFIG. 7Aincludes two light-transmitting plates710and720which are substantially parallel to each other. Entrance port730transverses light transmitting plate710and exit port740transverses the light-transmitting plate740. Both entrance port730and exit port740are in fluid communication with the conduit of the urine sampling system. Urine may enter the spectral analysis cell from the conduit through entrance port730then exit the spectral analysis cell through exit port740which leads back into the conduit. Entrance port730and exit port740may connect to the conduit at substantially the same or different positions along the length of the conduit. The space between light-transmitting plates710and720defines a urine analysis reservoir which holds a urine sample while the urine sample undergoes spectral analysis. The width of the space between light-transmitting plates710and720may be adjustable to achieve optimal spectral measurements. In the embodiment ofFIG. 7A, screws760and770may be turned to move light-transmitting plates710and720closer together or further from each other. This action adjusts the light path that a light source travels through during spectral analysis. In some embodiments, compliant seal795is positioned between light-transmitting plates710and720. In some embodiments, compliant seal795is an O-ring seal.

FIG. 7Bis a front view of the spectral analysis cell ofFIG. 7B. In addition to screws760and770shown inFIG. 7A, screws780and790are visible in the view shown inFIG. 7B. Other embodiments may include more or fewer screws than shown in the embodiments ofFIGS. 7A and 7B. In other embodiments, connectors known in the art, other than screws may be used to connect and move the light-transmitting plates.

FIG. 7Bshows a front view of compliant seal795which, in this embodiment, is an O-ring seal. Alternatively,FIG. 7Aillustrates a cross-section of the O-ring which is illustrated as two circles inFIG. 7A. Compliant seal795seals a small volume of urine in a light transmission section of the urine analysis reservoir through which a light source may pass during spectral analysis. Because compliant seal795is compliant, it may condense and expand as screws760,770,780, and790adjust the distance between light-transmitting plates710and720.

FIG. 8is a schematic drawing of the spectral analysis cell ofFIGS. 7A and 7Bas it may be used to conduct a spectral measurement on a urine sample. The spectral analysis cell is shown as a cross-sectional side view as first illustrated byFIG. 7A. Light source810emits light of multiple wavelengths which pass through filter820. A select range of wavelengths or a specific wavelength passes through filter820and then sequentially through light-transmitting plate710, a urine sample within the spectral analysis cell, then light-transmitting plate720. The light that is transmitted through light-transmitting plate720is then measured by spectrometer830.

FIG. 9is a schematic cross-sectional view of urine sampling system900, which is yet another embodiment of the disclosed urine sampling system. Urine sampling system900is similar to urine sampling system500ofFIG. 5. However, urine sampling system900includes sample/output port910. This embodiment includes a single port that functions both as a sample port and an output port. Urine sensor595may detect the presence of urine and send a signal to controller590. Controller590may then send signals which cause inlet valve540to open and peristaltic pump515to actuate. Because there is no separate output valve in this embodiment, controller590does not send a signal to close a second valve as in the embodiments ofFIGS. 5 and 6. Peristaltic pump515may function in a first direction which may pull urine from vertical slit230, through sample/outlet port910, and into conduit520. In some embodiments, controller590may send a second signal to inlet valve540causing it to close. The urine may enter a junction which includes spectral analysis cell560. After analysis is complete, controller590may send another signal to peristaltic pump515which causes peristaltic pump515to function in a second direction. In some embodiments, controller590may send a second signal to inlet valve540causing it to open. In response to peristaltic pump515functioning in the second direction, urine may move back up conduit520and out through sample/outlet port910.

FIG. 10is a flow chart illustrating a series of steps which the disclosed urine sampling system may conduct to collect and analyze a urine sample. The embodiment ofFIG. 10includes sensors that identify the presence of a user near the toilet or the presence of urine in the urine sampling system. Upon receiving the signal that a user or a urine sample is present, a controller sends a signal to the input valve on the conduit causing the input valve to open and a signal to the output valve on the conduit causing the output valve to close. Urine enters the vertical slit in the urine collection trap and is drawn into the urine collection trap through capillary action. A pump draws the urine sample from the vertical slit, through the input port and into the conduit. The sample is then subjected to one or more analysis assays which may include optical measurements and chemical analysis assays. The output valve is then opened and the urine sample exits the urine sampling system through the output port. In some embodiments, the urine sample is dispensed from the output port into the toilet water. In some embodiments, the urine sampling system is then rinsed by repeating the above-described steps with toilet water prior to the next user approaching the toilet.

While specific embodiments have been illustrated and described above, it is to be understood that the disclosure provided is not limited to the precise configuration, steps, and components disclosed. Various modifications, changes, and variations apparent to those of skill in the art may be made in the arrangement, operation, and details of the methods and systems disclosed, with the aid of the present disclosure.

Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and exemplary and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein.