Abstract:
A specimen collection receptacle formed by a channel disposed within the wall of a toilet bowl. The receptacle is located above the weir water line. The receptacle comprises a channel open to the interior of the bowl having opposed non-parallel side walls. The side walls may be joined opposite the opening. The side walls may be joined by a bottom wall. The bottom wall may be arcuate. The side walls may be non-planar. The walls may exhibit a roughened surface. The receptacle may comprise an optical window. The receptacle may comprise a cuvette. The receptacle may be in communication with one or more light emitting probes. The receptacle may be self-cleaning. The receptacle may comprise a replaceable module disposed in the wall of the toilet bowl. The receptacle may be located at the front of the toilet bowl. The receptacle may be disposed in a toilet bowl liner or insert.

Description:
FIELD OF INVENTION 
       [0001]    This disclosure relates to the field of specimen collection receptacles for analyzing samples in situ. More particularly, this disclosure teaches a collection receptacle disposed within the wall of a human waste disposal appliance, such as a toilet, urinal, or pot. The walls of the collection receptacle are configured to capture a sufficient sample and retain it long enough for in situ analysis by sensors or probes connected to the receptacle and then release the sample in the ordinary course of cleansing the receptacle. 
       BACKGROUND 
       [0002]    Human waste contains an unparalleled amount o health-related information. In particular, urine is routinely analyzed by healthcare professionals to obtain information regarding an individual&#39;s disease state, hormonal balance, nutritional status, pharmaceutical use, metabolic activity, microbial balance, risks of future health complications and other clinical points of interest. Conventionally, this information is obtained following sample submission to a laboratory; however, laboratory analysis typically only provides single-point data and is often a lengthy and awkward process for patients. Since human health is not an isolated event, the health information provided by the current testing methodology offers mere glimpses into an individual&#39;s health status. Ideally, key health measures would be assessed on an ongoing basis; however, the cost and inconvenience of laboratory analysis make regular testing prohibitive for the majority of people. In contrast, an on-site, in situ urine collection and analysis unit capable of delivering accurate, continuous and minimally invasive health testing would offer unprecedented longitudinal health-related information to individuals and healthcare professionals. Such in situ sample collection and analysis is most conveniently achieved at the typical site of urine excretion: the toilet, urinal, or pot. 
         [0003]    Urine collection methods designed for on-site urine analysis have been described previously. For example, U.S. Pat. No. 5,073,500 (hereafter referred to as reference 1, the entire disclosure of which is incorporated herein by this reference) describes a toilet apparatus which measures the concentrations of urinary components based on the specific wavelength-absorbing characteristics of a urine sample following passage through a liquid chromatograph. Urine is collected in a large funnel located at the front of the toilet bowl that channels samples into an automated liquid chromatography system, where it is separated into sample aliquots by gas injection, combined with a urinary component-specific reagent, forced through a liquid chromatograph and then exposed to a component-specific wavelength of light. The system is neither convenient nor practical for unassisted personal use. 
         [0004]    A more practical approach to analysis is described U.S. Pat. No. 5,772,406 (hereafter referred to as reference 2, the entire disclosure of which is incorporated herein by reference), which describes a toilet stool-based spectroscopic system that analyzes uric component concentrations by measuring urine sample absorbance of select wavelengths of visible or near-infrared light. In this system, a urine collecting basin is located in the front of a toilet bowl. Urine that enters the basin passes through a screen into a tube, where it is held back by a valve. When the system is ready process urine, the valve opens and urine flows down the tube through a spectral analysis cell to a closed secondary valve. A liquid sensor determines whether sufficient urine has been captured to fill the spectral analysis cell. If so, analysis is conducted. Following the analysis, the secondary valve is opened and the urine is evacuated to the sewage system. The system then undergoes a flush cycle which is monitored by a sensor to insure that the urine collecting part and the spectral analysis cell are sufficiently clean to assure valid analytical results. This is accomplished using a washing solution that is discharged front a nozzle located opposite to the urine collecting basin. Once the spectral analysis cell is sufficiently clean, a cell blank measurement of the empty cell or of a water-filled cell is taken to establish a clean reference for the next sample. 
         [0005]    Other creative methods employed for sample capture and analysis include U.S. Pat. No. 5,730,149 (hereafter referred to as reference 3, the entire disclosure of which is incorporated herein by reference), which describes an extensible, mechanically operated collection spoon. Following extension of the collection device, urine is captured mid-air and is forwarded via a flexible tube through the swing arm and spindle to the urinalysis device, where reagents are added to the sample for component quantification. U.S. Pat. No. 7,812,312 (hereafter referred to as reference 4, the entire disclosure of which is incorporated herein by reference) describes a system for analysis of aqueous systems using, attenuated total reflectance (ATR) crystals. In a toilet embodiment of the invention, the ATR body is preferentially designed as a flow-through cell with a reversibly closeable inlet and outlet incorporated into a separate sampling line branching from the toilet drain pipe. 
         [0006]    Perhaps the most feasible in-toilet urine collection approach is outlined in U.S. Pat. No. 5,815,260 (hereafter referred to as reference 6, the entire disclosure of which is incorporated herein by reference), which describes a toilet stool-based analytical system that measures the concentrations of erogenous components using Raman spectroscopy. Urine is collected in a frontal basin which is connected to a light-emitting fiber optic cable and a light-receiving fiber. The light-emitting cable transmits light from a laser source across the basin and through the sample to the light-receiving cable which conducts the resultant light to a Raman spectrometer. Following spectral analysis, the basin is cleared by flush water and drained through a scupper to prepare the basin for a new collection and sampling procedure. 
         [0007]    Unfortunately, previous attempts to facilitate automated urine specimen collection, preparation and analysis are hindered by mechanical complexity and difficulties in creating a spectral sampling pathlength of appropriate thickness that is also amenable to rapid sample evacuation and easy cleaning. For example, when sampling a liquid such as urine which is predominantly comprised of water with near-infrared spectroscopy, a transmission sample pathlength of 1 mm is necessary to obtain useitil results. While urine will flow through a gap of this size, the rate of flow is significantly hindered, and passage of a typical 300-800 mL sample of urine through such a space is unacceptably slow. Furthermore, expulsion of fecal matter into the collection unit represents a significant obstacle for quality analysis, especially if the fecal matter becomes lodged inside a collection tube with a 1 mm sampling area. In overcoming these obstacles, it is an object of the present invention to provide an automated urine specimen collection device capable of channeling urine through a spectral analysis site with a pathlength appropriate to the demands of the chosen spectrometer without significantly impinging the overall flow of urine or subsequent flush cycle. Additionally, the unit will be able to maintain a clean environment suitable to high quality spectral analysis. In so doing, the present invention allows for elegant in situ urine sampling and analysis. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention describes a receptacle for the in situ collection, preparation and analysis of urine samples within the toilet bowl cavity. Urine is excreted into the toilet bowl or a toilet insert and channeled by flow-directing protrusions towards a vertically oriented spectral flow cell. Urine passing through the flow cell or retained by the flow cell is optimally situated for spectral assessment. Light is transmitted through the sample from a light-emitting probe to a light-receiving probe and passed to a spectrometer for assessment. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0009]      FIG. 1  is a diagram of the in situ specimen collection receptacle comprising an analysis channel or flow cell. 
           [0010]      FIG. 1 a    is a transparent view of  FIG. 1  which depicts the positioning of the fiber optic cables relative to the analysis channel or flow cell. 
           [0011]      FIG. 2  is a depiction of a collection device disposed within a toilet bowl. 
           [0012]      FIG. 3  is a diagram of a sectional view of the toilet. 
           [0013]      FIGS. 4 a -4 d    are cross-sectional views of the analysis channel or flow cell configurations. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0014]      FIG. 1  is a diagram of the in situ specimen collection receptacle  10  comprising an analysis channel or flow cell  11 . The receptacle is connected to a spectro analyzer ( FIG. 3   19  and transmission device  18 ) by fiber optic cables  12 . 
         [0015]      FIG. 1 a    is a diagram of the in situ specimen collection receptacle as shown in  FIG. 1 a    further depicting the fiber optic cables  12  in communication with the analysis channel or flow cell  11  at a fiber optic cable interface  13  that may include light emitting and light receiving cable ends, collimating lenses, or a spectral window. 
         [0016]      FIG. 2  is a diagram of a floor mounted toilet  14  comprising a water supply tank  17  a bowl  16  and a weir water line  15 . Also depicted is the analysis channel  10  located above the weir water line. 
         [0017]      FIG. 3  is a diagram of a longitudinal sectioned view of the toilet  14 . The toilet comprises a water supply tank  17 , a bowl  16 , a weir  20 , and weir water line  15 , the collection receptacle  10  connected by means of a fiber optical cable  12  to a spectral analyzer  19  and transmission device  18 . The spectral analyzer is connected to a monitor that is not shown. The collection receptacle  10  may be located at the front of the bowl  16 . The front surface of the bowl  16  may be inclined. The location of the collection receptacle  10  should be convenient fur both male and female urination events. Also, the location should be above the weir water line  15 . Water from the tank  17  that enters the bowl  16  during the flush cycle may be used to cleanse the analysis channel  11  and the fiber optic cable interface  13 . Additionally, a cleansing solution may be added to the tank&#39;s water supply to insure adequate cleansing. The cleansing solution may be applied to the channel  11  from a nozzle, not shown, positioned in the bowl wall  16  and directed toward the channel  11 . 
         [0018]      FIGS. 4 a -4 d    are cross-sectional diagrams  21  of the receptacle  10 . The analysis channel&#39;s opposed walls  24 ,  26 , and  30  feature non-parallel configurations. Side wall  24  form a truncated cone shape; side wall  26  form reentrant side walls, and side walls  30  are curvilinear, such as convex or concave. Channel wall  29  features a non-planar surface. The variety of wall configurations and surface finishes are intended to control the sample flow through the analysis channel  11 , maximize sample volume, promote capillary adhesion of the sample during analysis, restrain ambient light, and facilitate cleansing. The volume of the analysis channel  11  should be about at least 5 mL. The volume of the channel  11  proximate the cable interface  13  should be at least 150 μL and not more than 2 mL. Preferably, the volume should be around between 300 μL and 600 μL. The actual volume proximate the cable interface  13  may vary depending on the nature of the analysis and the equipment used. 
         [0019]    In the preferred embodiment, urine is excreted by the user into a toilet bowl  16  or a toilet insert and flows down to the urine specimen collection receptacle  10  which lies flush with the surface of the toilet bowl  16  or insert. Protrusions from the surface of the collection receptacle direct urine flow towards the analysis channel or flow cell  11 . Excess urine overflows the protrusions and drains into the reservoir of the toilet bowl or insert  16 , leaving a tiny pool of urine that gravimetrically feeds through the analysis channel or flow cell  11 . Once flow through the cell has ceased, the capillary effect ensures that a residual amount of urine fills the flow cell  11 , covering the light transmission site  26 . Either during the flow-through period or after capture of a sample via the capillary effect, light is transmitted through the sample from a light-emitting fiber optic cable  12  to a light-receiving fiber optic cable  22 . Light captured by the light-receiving cable  22  then passes down the fiber optic cable to the spectrometer  19 , where it is reflected, diffracted and focused onto a photodetector to generate spectral data on the urine sample using the transmission device  18 . When the toilet is flushed, water from the flush cycle is again channeled to and through the flow cell  11 , displacing the urine and allowing it to exit with the rest of the bodily waste. 
         [0020]    In one embodiment, the analysis channel  1  comprises a vertically-oriented gap  27  open to the bowl  16 . This gap  27  is of a width that best fits the spectral path length requirements of the requisite spectrometer(s) and may range from 0.01-1.3 mm, with a preferred width of 0.5-2 mm. For example, in one embodiment, a gap  27  of 1 mm provides the ideal pathlength for a urine sample when the channel  11  is coupled with a near-infrared spectrometer. Fiber optic cables  12 ,  22  with core sizes ranging from 0.1-1,000 μm, with the preferred core size ranging from 1-600 μm, are placed in close proximity to the edge of the gap  27 . Preferentially, these will be multi-mode fibers. Both fibers need not have the same configuration or core size. Furthermore, the cables  12 ,  22  will have a maximum angle of curvature which cannot be exceeded and may be contained within a stable housing to ensure an optimal radial conformation. Alternatively, the light-emitting or light-receiving elements of the flow cell  11  may be placed in a straight, direct alignment with the light source or spectrometer  19 . The surface of the gap  27  will preferentially contain one or more optical elements  13  such as cable ends, collimating lenses or a spectral window. These optical elements may be formed from any arbitrary material which is transparent to the radiation employed by the spectrometer light source, especially to electromagnetic radiation in the ultraviolet, visible, near-infrared or middle infrared regions. Alternatively, the entirety of the collection receptacle  11  may be formed from an optic material to provide a seamless optic environment. The presence and type of these flow cell components is conditional on the specific requirements of the spectrometer and sampling techniques. 
         [0021]    In an embodiment, the analysis receptacle  11  exhibits non-parallel side walls  24 , in order to maximize the volume of the channel  11 , promote sample retention, and post analysis cleansing. In another embodiment that side walls  26  may exhibit a reentrant configuration in order to control ambient light that may iaterfert with the spectral analysis. Other embodiments may comprise non-planar side walls  29  comprising corrugations, channels, discontinuities, or protrusions to control sample flow and aid in retention of the sample during analysis. And the side walls  30  may be curvilinear, such as concave or convex, in order to accommodate the spectral analysis, facilitate cleaning, and sample retention. It may be desirable that the side walls  24 ,  26 ,  29  and  30  comprise a combination of features as disclosed herein. The bottom walls  23 ,  25 , and  28  may incorporate the features of the other side walls. The bottom wall may be stepped as a means for controlling the flow of the sample through the channel  11 . Baffles may be added to the channel  11  for sample retention and control. The channel  11  may not have a bottom wall  23 ,  25 , and  28  when it is desirable to have the side walls converge at the bottom forming a V shaped channel. The walls  23 ,  24 ,  25 ,  26 ,  28 ,  29 , and  30  may comprise a replaceable insert to facilitate cleaning and maintenance. The insert could be fashioned so as not to interfere with the light emitting or receiving ends of the fiber optic cables  12 ,  22 . At least a portion of the walls may exhibit a polished surface, even a mirror polished surface, in order to promote capillary adhesion and cleansing. For example only the proximal region of the channel  11 , the region before the spectral window or fiber optic cable interface  13 , may be polished while the distal region of the channel  11 , the region after the spectral window or fiber optic cable interface, could be non-planar. Also, the channel wall region surrounding the fiber optic cable interface  13  may be polished while the remainder of the channel  11  may be non-planar. The channel walls and may comprise a hydrophilic material or coating. Contrariwise, the bottom wall of the channel  11  may comprise a hydrophobic material or coating that creates droplets suitable for spectral analysis. 
         [0022]    The inventors have successfully experimented with the analysis channel or flow cell  10  as described herein and have developed algorithms for the spectral analysis of Urea, Creatinine Glucose, Amylase, Uric acid, and Ethanol. 
         [0023]    Additionally, the collection receptacle  10  may include a temperature sensor such as a thermistor. Immediately following excretion, the temperature of urine is approximately equal to the temperature of the human body (37° C.) and substantially exceeds normal room temperature (25° C.). Therefore, contact with urine constitutes a signal event for the temperature sensor that can be used to identify the presence of urine in the flow cell  11 . Once the presence of urine in the flow cell  11  has been identified, the spectrometer and light source  19  will be activated for sampling. 
         [0024]    Finally, the collection device may include an integrated cleaning apparatus. This may include a spray or drip nozzle designed to release a wash solution into the flow cell to remove build-up on the surface of the flow cell or clear remaining flush water in the flow cell with a rapidly evaporating liquid such as alcohol. The cleaning apparatus may also feature a fan or compressed air nozzle designed to circulate air through the flow cell and improve clearance of residual urine, water or wash solution from the flow cell. Once the flow cell has been cleared of fluid, a timed reference scan may be initiated by the spectrometer. 
         [0025]    The embodiment described here is provided to illustrate the function of the device and is not intended to confine the invention to a specific set of design elements, conformations or optical components. Modifications to the overall mechanical, optical or electrical design in keeping with the intent of the device may be made to improve the unit without undermining the validity of this application.