Systems and methods for in situ measurement and collection of samples of analyte concentrations in body fluids - Patents.com

Abstract

The system and associated method includes a durable component, an indicator component including an indicator zone with at least one colorimetric analyte sensing element, at least one moisture sensor, and a fluid collection reservoir. The durable component houses at least one spectrophotometer, a computing system, and a means for electronic communication between the computing system and at least one external device. The indicator component includes at least one colorimetric analyte sensing element and a fluid transfer layer in fluid communication with the indicator zone, and is arranged and configured for attachment to the durable component. Additionally, the moisture sensor is arranged and configured to communicate the presence of moisture to initiate a predetermined delay in measuring the concentration of the at least one analyte. The fluid collection reservoir is releasable from at least one of the indicator component and the durable component at a predetermined break point for clinical analysis.

Description

[Technical Field]

[0001] The present invention relates to systems for measuring changes in analyte concentrations in bodily fluids in situ while simultaneously collecting samples for later analysis. More specifically, the present invention relates to systems used to measure analyte concentrations in urine over time and methods for measuring these analytes and detecting early-onset disease states in the human body. These systems have reservoirs for simultaneously collecting bodily fluids for later analysis to confirm the in situ analysis and / or to facilitate clinical studies. [Background technology]

[0002] Analytes found in bodily fluids, such as urine or sweat, potentially carry evidence of developing local and / or systemic health problems. There is a need for people both within and outside of medical facilities to track and analyze changes in the concentrations of analytes in bodily fluids over time.

[0003] Currently, people and doctors rely on visible symptoms to diagnose systemic metabolic problems. This often prompts doctors to perform urine or blood tests to determine the presence or concentration of various analytes in these bodily fluids. Therefore, in today's practice, tests such as urine analyses are most frequently used to confirm symptom-based diagnoses rather than as an initial identification of disease. Some conditions, such as diabetic ketoacidosis, only show visible symptoms when an individual's condition may already warrant an emergency visit to a physician. Other conditions, such as urinary tract infections, do not show visible symptoms and may result in kidney scarring, which may not manifest as a health problem until years later.

[0004] Noninvasive measurement of analyte concentrations in urine content is also ideally suited for epidemiological studies to rapidly identify common problems in specific regions, however, difficulties in sample collection hinder the acceleration of research within this field.

[0005] Most absorbent articles with sensors, such as diapers, have embedded sensors that can only detect wetness, and some of them can qualitatively assess the presence of biomarkers. Often, they transmit that information to a receiving system, which then alerts a caregiver to a one-time event. These wetness detection systems do not perform a diagnostic.

[0006] As an example, U.S. Patent No. 10,462,750 (B2) purports to disclose a diaper that reports the presence of a target biomarker. Unfortunately, the qualitative report of the biomarker cannot determine the concentration of that biomarker (a measure of significant value in clinical research and diagnostics).

[0007] Some existing diagnostic systems rely on urine test strips that are dipped into a urine sample and read manually or automatically by an imaging device or a cell phone. Other diagnostic systems rely on urine test strips mounted on the exterior of an absorbent article and, once wetted, read manually or automatically by an imaging device or a cell phone. In either case, data from a current reading can be compared to both past and future readings.

[0008] In either approach, a reading of the urine test strip is taken at a time point after the strip has been wetted with urine. Many of the chemicals used in test strips are sensitive to exposure time, temperature, wetness, etc. Therefore, accurate and reproducible readings are difficult to obtain. These systems also lack the ability to corroborate determined readings with analyte readings determined by laboratory procedures. Accuracy and reproducibility are important for tracking changes in analyte concentration over time.

[0009] In summary, analytes found in bodily fluids can be evidence of developing local and / or systemic health problems. There is a desire to track and analyze changes in the concentration of analytes in bodily fluids, such as urine, over time. However, for the data to be useful, the readings must be accurate and reproducible.

[0010] In addition to the in situ analysis of bodily fluids using the test strips and kits described above, clinical research and analysis employ the collection of bodily fluid samples for subsequent analysis in specialized laboratories that can screen for a broader panel of molecular biomarkers. Unfortunately, simultaneous collection of samples for laboratory analysis and accurate in situ analysis of the same bodily fluid is not possible. Therefore, determining the accuracy of an in situ testing system requires the comparison of two sets of data—one clinical data and the other in situ data. Summary of the Invention [Problem to be solved by the invention]

[0011] Therefore, what is needed is a system that can provide accurate and immediate in situ body fluid analysis and that can allow for the simultaneous collection of the same body fluid for subsequent analysis of a broader panel of molecular biomarkers. [Means for solving the problem]

[0012] The inventors have invented a system that combines an easy-to-use device capable of delivering accurate in situ analysis of bodily fluids for use by home caregivers, accurate enough for clinical testing, with simultaneous sample collection for panel confirmation or expansion of panel size for more detailed insight into such in situ analysis.

[0013] The system includes a durable component, an indicator component including an indicator zone with at least one colorimetric analyte sensing element, at least one moisture sensor, and a fluid collection reservoir. The durable component has a housing with at least one window and houses at least one spectrophotometer adjacent to and in optical communication with the window, a computing system having at least one processor and data storage device, and means for electronic communication between the computing system and at least one external device. The indicator component includes the at least one colorimetric analyte sensing element and a fluid transfer layer in fluid communication with the indicator zone, and is arranged and configured to be attached to the durable component while the indicator zone is disposed adjacent to and in optical communication with the at least one window and the at least one spectrophotometer, and the computing system is operably connected to the moisture sensor and the at least one spectrophotometer. Additionally, the moisture sensor is arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to the computing system, and each of the at least one colorimetric analyte sensing elements is associated with a spectrophotometer. The fluid collection reservoir has a fluid impermeable wall and a port in fluid communication with the fluid transfer layer, and is releasable from at least one of the indicator component and the durable component at a predetermined break point.

[0014] A novel and useful method for measuring an analyte concentration in a bodily fluid includes collecting and transporting the bodily fluid to at least one colorimetric analyte sensing element and at least one fluid collection reservoir, where the colorimetric analyte sensing element detects the presence of the bodily fluid in contact with the at least one colorimetric analyte sensing element. Additional steps include collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer a predetermined time period after detecting the presence of the bodily fluid in contact with the colorimetric analyte sensing element, communicating the optical data to a computing system having at least one processor and data storage device, and analyzing the optical data to determine the concentration of at least one analyte in the bodily fluid. Additionally, the method includes sealing the fluid collection reservoir for transport of the sealed fluid collection reservoir to a laboratory for laboratory analysis of the at least one analyte concentration.

[0015] Another novel and useful method for measuring an analyte concentration in a bodily fluid includes obtaining a durable component, removing an indicator component from an individual package, and bonding the indicator component to the durable component. The indicator component includes a transport layer, an indicator zone with at least one colorimetric analyte sensing element, a fluid collection reservoir having a fluid-impermeable wall and a port in fluid communication with the fluid transport layer. The fluid collection reservoir is releasable from the indicator component at a predetermined break point. The durable component has a housing with at least one window and houses at least one spectrophotometer adjacent to and in optical communication with the window, a computing system having at least one processor and data storage device, means for electronic communication between the computing system and at least one external device, and at least one moisture sensor. The indicator zone is positioned adjacent to and in optical communication with the at least one window and the at least one spectrophotometer, and the computing system is operably connected to the moisture sensor and the at least one spectrophotometer. The moisture sensor is disposed adjacent to the indicator zone, and each of the at least one colorimetric analyte sensing elements is associated with a spectrophotometer. The method also includes placing the assembled device in contact with a source of bodily fluid, collecting and transporting the bodily fluid to the at least one colorimetric analyte sensing element, and detecting the presence of the bodily fluid in contact with the at least one colorimetric analyte sensing element. The method further includes collecting optical data regarding the at least one colorimetric analyte sensing element using the at least one spectrophotometer a predetermined time period after detecting the presence of the bodily fluid in contact with the colorimetric analyte sensing element, communicating the optical data to a computing system having at least one processor and data storage device, and analyzing the optical data to determine the concentration of at least one analyte in the bodily fluid.The method also includes removing the fluid collection reservoir from the indicator component and sealing the fluid collection reservoir port to seal the fluid collection reservoir for transport of the sealed fluid collection reservoir to a laboratory for laboratory analysis of at least one analyte concentration. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a bottom perspective view of a system for measuring analyte concentration and for sample collection of the present invention. [Figure 2] FIG. 2 is a top perspective view of the system for measuring analyte concentration and for sample collection of FIG. 1. [Figure 3] FIG. 2 is a side view of the indicator and sample collection components of the system of FIG. 1. [Figure 4] FIG. 4 is an exploded top perspective view of the indicator and sample collection components of the system of FIGS. 1-3. [Figure 5] FIG. 5 is a top perspective view of a fluid-impermeable envelope encapsulating the colorimetric analyte-sensing element of the indicator and sample collection component of FIG. 4. [Figure 6] FIG. 5 is a top view of a fluid-impermeable envelope encapsulating the colorimetric analyte-sensing element of the indicator and sample collection component of FIG. 4. [Figure 7] FIG. 5 is a top view of the partially assembled indicator and sample collection component of FIG. 4. [Figure 8] FIG. 5 is a bottom view of the partially assembled indicator and sample collection component of FIG. 4. [Figure 9] FIG. 3 is a top perspective view of a durable component of the system of FIGS. 1 and 2. [Figure 10] FIG. 3 is a top view of the durability components of the system of FIGS. 1 and 2. [Figure 11] FIG. 2 is a partial side view of the system of FIG. 1. [Figure 12] FIG. 4 is a partial bottom perspective view of the indicator component of FIG. 3. [Figure 13]FIG. 1 is a top view of a moisture sensor element of an indicator component of a system for measuring an analyte concentration in an absorbent article as a moisture front traverses the element. [Figure 14] 1 is a capacitance versus time plot as a moisture front traverses a moisture sensor element of an indicator component of a system for measuring analyte concentration. [Figure 15] 1 is a top perspective view of a system for measuring analyte concentration in a body fluid and for sample collection of the present invention. [Figure 16] FIG. 16 is a top perspective view of the indicator component and sample collection of the system of FIG. 15. [Figure 17] FIG. 16 is a partially exploded view of the indicator component and sample collection system of FIG. 15. DETAILED DESCRIPTION OF THE INVENTION

[0017] The present invention relates to a system for use with absorbent articles for in situ measurement of the concentration of analytes in bodily fluids, such as urine, over time, which allows for the monitoring of analytes in such fluids, and methods for using the system to measure the concentration of analytes in bodily fluids over time, as well as methods for using these analyte measurements over time to detect early-onset disease states in the human body. These systems include a reservoir for simultaneous collection of bodily fluids to confirm the in situ analysis.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter described herein belongs. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety.

[0019] As used herein and in the claims, the term "panel" or "test panel" and variations thereof refer to a predefined group of medical tests or analyses used to aid in the diagnosis and treatment of disease.

[0020] The present invention relates to systems and methods that allow for monitoring of analyte concentrations in absorbent articles. The systems and methods also allow for statistical analysis and determination of changes in health status through the collection of multiple data points over time, which may be evidence of developing metabolic problems. Other data, such as medical and family history, and current variables, such as age, temperature, and / or other current markers, may be used to supplement trend and statistical analysis.

[0021] A device or system for collecting a sample of a bodily fluid and measuring an analyte concentration in the bodily fluid may be associated with an absorbent article. The system has an indicator component and a durable component. The indicator component includes an indicator zone having a colorimetric analyte sensing element that may be disposed within an optional flexible web, a fluid transfer layer, an optional first flexible web, an optional top plate, a coupler that may be a retaining plate, an adhesive layer, and a fluid collection reservoir. The indicator component is preferably disposable.

[0022] The colorimetric analyte sensing element has perforations and is disposed within the openings in the second flexible web. The colorimetric analyte sensing element can be a reagent-impregnated matrix designed to produce a visual indication of the presence of a preselected analyte in a sample produced by a wearer of the system. The preselected analyte measured by the system can be, among others, glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cells, and / or creatinine.

[0023] For example, the absorbent article can be a diaper, the fluid being tested can be urine, and the preselected analyte measured by the device or system for measuring analyte concentrations can be glucose. Glycosuria, or urinary glucose, is the presence of higher-than-normal levels of sugar in urine and can result from an individual's kidney complications or diabetes. Some of the most common causes of urinary glucose include diabetes mellitus, hyperthyroidism, benign diabetes, cirrhosis of the liver, or a high-carbohydrate diet. Biosensors capable of converting preferred biomarkers into calorimetrically readable results can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers present in urine and can be used in the systems of the present invention.

[0024] As described above, the colorimetric analyte sensing element disposed within the opening of the second flexible web is in fluid communication with the fluid transfer layer. The fluid transfer layer is in turn in fluid communication with the first flexible web. The second flexible web has a first side and is made of a non-absorbent material, such as polyethylene foam. The fluid transfer layer has a first side and perforations and is made of a wicking material, such as cloth or paper, that is effective in diffusing and transporting fluids via capillary action. The first flexible web has a first side and perforations and is made of a non-absorbent apertured film, such as polyethylene mesh.

[0025] The second flexible web, fluid transfer layer, and first flexible web are designed to assist in the transport of fluid to the colorimetric analyte sensing element. During use, fluid from the absorbent article first contacts the first side of the first flexible web. Because the first flexible web is a non-absorbent apertured film, the fluid passes through the first flexible web and contacts the first side of the fluid transfer layer. The fluid then permeates the entire fluid transfer layer. The fluid will then contact the first side of the second flexible web. However, because the second flexible web is made of a non-absorbent material, the fluid in the transfer layer does not penetrate into the second flexible web. Finally, the fluid in the transfer layer contacts the colorimetric analyte sensing element.

[0026] The sensing element disposed within the second flexible web, the fluid transport layer, and the first flexible web are stacked and held together by a top plate and a retaining plate. The retaining plate has pins that pass sequentially through the perforations in the colorimetric analyte sensing element, the perforations in the fluid transport layer, and the perforations in the first flexible web. Although not shown, the top plate has blind holes in which the pins are disposed. A friction fit between the blind holes in the top plate and the pins holds the components of the indicator component together. Alternative assemblies can be held together by other interactions, such as snap fits, ultrasonic welding, heat welding, other mechanical fasteners, and the like.

[0027] The top plate and the retaining plate are arranged and configured to provide a predetermined spacing for accommodating an indicator component layer with a predetermined fluid transport capacity to the indicator zone, which provides a more controlled delivery of bodily fluid to the indicator zone and the associated timing between the bodily fluid reaching the indicator zone and the colorimetric measurement, as described in more detail below.

[0028] The top plate may have channels on the side facing the first side of the first flexible web. The channels may help direct fluid from the absorbent article to the first side of the first flexible web.

[0029] The durable component has a housing with a window. A spectrophotometer is disposed within the housing. The spectrophotometer components include a light source and a photodetector. The spectrophotometer is adjacent to and in optical communication with the window within the housing. This allows the spectrophotometer to be in optical communication with the colorimetric analyte sensing element of the indicator component.

[0030] The spectrophotometer may include at least two or more light sources and at least two photodetectors, for example, at least four or more light sources and at least four or more photodetectors.

[0031] A male connector protrusion surrounding a window on the housing allows the durable component to be releasably attached to the indicator component. The durable component of the system for measuring an analyte concentration in an absorbent article has a conductive strip disposed on an upper surface of the male connector protrusion, the conductive strip functioning as a moisture sensor arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to a computing system disposed within the durable component.

[0032] The light sources and photodetectors may be linearly arranged and evenly spaced within the housing of a system for measuring analyte concentrations in absorbent articles and are typically located on a printed circuit board (PCB). The PCB mechanically supports and electrically connects the electronic components using conductive tracks, pads, and other features etched from copper sheets laminated onto a non-conductive substrate. Components (e.g., capacitors, resistors, controllers, power supplies, light sources, detectors) are typically soldered onto the PCB. The PCB can be supported within the housing of a durable component by a support bracket or can be attached directly to the interior surface of the housing.

[0033] The PCB has a computing system having one or more processors and memory, and means for electronic communication for transmitting the results of the analysis to a data processing system external to the system for measuring analyte concentrations in absorbent articles. Data processing systems that may be used include a server computer, a client computer, and at least one external device, including a handheld device such as a mobile phone.

[0034] The light source and photodetector components of the spectrophotometer are located on the surface of the PCB. They may be shielded from ambient light by a panel or shield. A skirt may be attached to the surface of the PCB to optically isolate the photodetector from the light source. Thus, during operation, light emitted from the light source cannot impinge on the photodetector without reflecting off the colorimetric analyte sensing element.

[0035] Alternatively, a lens may be placed over the light source such that, in operation, light emitted from the light source cannot impinge on the photodetector without reflecting off the colorimetric analyte sensing element. Potting material may also be used to focus the light from the light source onto the colorimetric analyte sensing element.

[0036] The light source may be a light-emitting diode (LED), a semiconductor light source that emits light when current passes through it. LEDs have many advantages over incandescent light sources, including lower energy consumption, longer lifespan, improved physical robustness, smaller size, and faster switching. The light source may be an RGB LED. Mixing red, green, and blue sources can produce white light with an appropriate blend of colors. Additionally, the color emitted from an RGB LED may be monochromatic, allowing data to be acquired within a narrow wavelength range.

[0037] Photodetectors are also called photosensors. They are sensors of light or other electromagnetic radiation. They have a pn junction that converts photons into electrical current. Absorbed photons create electron-hole pairs in the depletion region. Certain photodetectors can measure the amount of white light received.

[0038] Other photodetectors specifically measure red, green, and blue light, allowing data to be obtained over a narrow wavelength range. In systems employing red, green, and blue light, a light source may emit light in narrow red, green, and blue wavelengths. The emitted light waves reflect off the colorimetric analyte sensing element. A photodetector measures the reflected light. Sequential emission of red, green, and blue light allows for the near-simultaneous collection of three data points. Alternatively, the order of the emitted red, green, and blue light may be varied.

[0039] The components of the spectrophotometer may be coated with a protective material that prevents moisture from the colorimetric analyte sensing element from contacting and potentially damaging the components of the spectrophotometer.

[0040] The indicator component is arranged and configured to be releasably attached to the durable component, and when assembled, the colorimetric analyte sensing element is disposed adjacent to and in optical communication with the window and the spectrophotometer element.

[0041] The conductive strip is disposed on top of the male connector protrusion of the housing of a system for measuring an analyte concentration in an absorbent article. The conductive strip acts as a moisture sensor within the system and is arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to a computing system disposed within the durable component. The computing system disposed within the durable component is in turn operatively connected to the moisture sensor and spectrophotometer components. The function of the conductive strip in the moisture sensor is described below.

[0042] The moisture sensing system described above allows a spectrophotometer to perform readings of the emitted light waves reflected from the colorimetric analyte sensing element at a time after the strip is wetted with moisture. This overcomes the problem that the chemicals used in the test strip are sensitive to time, temperature, and wetness, allowing accurate and reproducible readings to be obtained.

[0043] Four narrow-beam LEDs are used, spaced apart around the photodetector. Thus, the onset of wetting can be detected by a change in impedance through the conductive strip; for example, four narrow-beam LEDs can be spaced around the photodetector. The accuracy of the onset of sufficient saturation of the colorimetric analyte sensing element can be improved by sequentially activating each of the narrow-beam LEDs and comparing the light detected by the photodetector. If there is a significant difference between the data returned by the photodetector as a result of different narrow-beam LEDs, the colorimetric analyte sensing element may not be sufficiently saturated for reliable analysis. Thus, the system can begin collecting optical data about the colorimetric analyte sensing element after a predetermined period of time following bodily fluid contact with the colorimetric analyte sensing element, as determined by (1) a change in impedance through the conductive strip and (2) relatively consistent data returned by the photodetector as a result of different narrow-beam LEDs, indicating substantially uniform wetting of the colorimetric analyte sensing element.

[0044] While the above description refers to a system for measuring an analyte concentration in an absorbent article having an indicator component and a durable component, it is envisioned that in some cases, the durable component may be combined with multiple indicator components to create a kit for measuring an analyte concentration in an absorbent article. The kit has at least one, and preferably one or more, individually packaged indicator components. This allows the kit to measure the analyte concentration in the absorbent article daily, weekly, or monthly, or more than once a day, week, or month. When used in this manner, the system is used to track changes in the measured analyte concentration over days, weeks, months, or even years.

[0045] Disposable absorbent articles for use in systems for measuring analyte concentrations include absorbent hygiene articles such as diapers (including baby diapers, training pants, and adult incontinence products) and pads (including feminine sanitary napkins and panty liners and nursing pads).

[0046] For example, an absorbent article for use in a system for measuring an analyte concentration is a diaper, and the analyte concentration is measured in urine. The indicator component has an attachment means, such as an adhesive layer. The adhesive layer is used to attach or bond the indicator component of the system to the fluid transfer layer of the diaper. The system may be attached to the body-facing surface of the diaper. Other attachment means will be readily apparent, including, but not limited to, mechanical fasteners such as clips, clamps, hook-and-loop systems, and bands, magnetic (including electrostatic), friction, and the like. The indicator component may be arranged and configured to be releasably attached to the diaper.

[0047] As described above, a system for measuring analyte concentrations in an absorbent article uses a colorimetric analyte sensing element to generate a visual indication of the presence of a preselected analyte in a sample freshly generated by the wearer of the system. The system also includes a means for collecting fluid for later analysis. The indicator component's retaining plate has a fluid collection reservoir attached thereto by a reservoir connector. The fluid collection reservoir may include an absorbent material, such as a sponge, to collect bodily fluids, such as urine. A sponge impregnated with boric acid and sodium formate (a urine preservative), such as UNISPONGE, a trademark registered by COPAN Diagnostics (Murrieta, CA), may be used. Other urine-absorbent materials include woven or nonwoven fibers of natural or synthetic materials, or absorbent gels. Superabsorbent polymers (SAPs), such as HYSORB SAP from BASF (Ludwigshafen, DE), are also suitable.

[0048] Fluid collected by the fluid collection reservoir can be sent to a comprehensive testing site for confirmation to compare the concentrations determined by the colorimetric analyte sensing element with concentrations determined by a "gold standard" testing method to confirm the in-situ analysis. Tests can also be run on an expanded panel for more detailed insight into such in-situ analysis, i.e., for other analytes not measured by the colorimetric analyte sensing element, to provide a more comprehensive determination of the user's health.

[0049] The fluid collection reservoir includes a sealable container body for receiving bodily fluid and a port through which the bodily fluid enters the reservoir. The container body has a liquid-impermeable wall and is made of a rigid or semi-rigid material such as an elastomeric plastic. The port may have a one-way valve that allows the bodily fluid to enter the reservoir.

[0050] The fluid collection reservoir is in fluid communication with the fluid transfer layer and may contain an absorbent material such as a sponge, woven fabric, nonwoven fabric, or absorbent gel as described above. The absorbent material contained within the fluid collection reservoir can draw bodily fluid from the fluid transfer layer. Drawing of bodily fluid from the fluid transfer layer into the reservoir may be achieved by a capillary gradient to draw a sample of bodily fluid into the reservoir.

[0051] The fluid collection reservoir is removable from the indicator component at a predetermined break point. The reservoir is sealable so that it can be capped when separated from the indicator component. The closure of the fluid container reservoir may include a flip top, snap top, or screw top to close and seal the container.

[0052] The fluid collection reservoir can be disposed within an opening in a reservoir retriever on the durable component. When the durable component is removed from the retainer plate, the reservoir retriever can detach the fluid collection reservoir from the retainer plate. A twist-off feature can be included to aid in removal of the fluid collection reservoir from the retainer plate.

[0053] The subject matter of the present disclosure will now be described more fully below with reference to the accompanying drawings and examples. However, the subject matter of the present disclosure may be embodied in different forms and should not be construed as limited to any specific embodiment described herein, but is to be accorded the widest scope consistent with the features described herein. Rather, any specific embodiment is provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art to which the invention pertains. It is believed that one skilled in the art can utilize the present invention to its fullest extent based on the description herein.

[0054] A system for measuring an analyte concentration in an absorbent article may have multiple colorimetric analyte sensing elements. Figures 1 and 2 show a system for measuring an analyte concentration in an absorbent article of the present invention. System 100 includes an indicator component 120 and a durable component 200. Figures 1 and 2 are top and bottom perspective views, respectively, of system 100 when fully assembled.

[0055] Indicator component 120 is shown in a side view in Figure 3 and in an exploded view in Figure 4. Indicator component 120 includes an indicator zone 121 having a pair of colorimetric analyte sensing elements, i.e., a first colorimetric analyte sensing element 130a and a second colorimetric analyte sensing element 130b. First colorimetric analyte sensing element 130a has first and second sides 132a and 134a and a perforation 136a. Second colorimetric analyte sensing element 130b has first and second sides 132b and 134b and a perforation 136b.

[0056] The colorimetric analyte sensing elements 130a, 130b may be reagent-impregnated matrices designed to produce a visual indication of the presence of a preselected analyte in a sample produced by the wearer of the system 100. Chemistry and methods for detecting analytes by producing a visual indication are well known in the art. The preselected analytes measured by the system 100 may be glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, among others.

[0057] The colorimetric analyte sensing elements 130a, 130b may be designed to produce a visual indication of the presence of the same preselected analyte in a sample produced by a wearer of the system 100. In this case, the colorimetric analyte sensing elements 130a, 130b act to confirm the analysis. The colorimetric analyte sensing elements 130a, 130b may also be designed to produce a visual indication of the presence of different preselected analytes in a sample produced by a wearer of the system 100.

[0058] Again, the absorbent article may be a diaper, the fluid being tested may be urine, and the preselected analyte measured by system 100 may be glucose. Glycosuria, or urinary glucose, is the presence of higher than normal levels of sugar in the urine and may result from an individual's kidney complications or diabetes.

[0059] A preselected analyte measured by system 100 can also be ketones. When cells in the body do not get enough glucose, the body burns fat for energy instead. This produces ketones, which can appear in the blood and urine. High ketone levels in the urine can indicate diabetic ketoacidosis (DKA), a complication that can lead to coma or even death.

[0060] Some of the most common causes of glucose in urine include diabetes mellitus, hyperthyroidism, benign diabetes, cirrhosis of the liver, or a high carbohydrate diet. Biosensors capable of converting preferred biomarkers into calorimetrically readable results can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers present in urine and can be used in the systems of the present invention.

[0061] Other components of indicator component 120 include an optional top plate 170, an optional first flexible web 160, a fluid transfer layer 150, a second flexible web 140, an adhesive layer 190, and a coupler 180, shown here as a retaining plate.

[0062] The colorimetric analyte sensing elements 130a, 130b are encapsulated between a first encapsulation layer 310 and a second encapsulation layer 330 to form a fluid-impermeable envelope 331. The first encapsulation layer 310 has a first side 312 and a second side 314, as well as perforations 316 and openings 318. The second encapsulation layer 330 has a first side 332 and a second side 334, as well as perforations 336 and openings 338.

[0063] Figure 5 is a top perspective view of a fluid-impermeable envelope 331 encapsulating the colorimetric analyte sensing elements 130a, 130b of the indicator component 120 of the system 100. Figure 6 shows a top view of the fluid-impermeable envelope 331 encapsulating the colorimetric analyte sensing elements of Figure 5. The figure shows, in solid lines, the first side 332, perforations 336, and openings 338 of the second encapsulation layer 330. The figure shows, in dashed lines, the colorimetric analyte sensing elements 130a, 130b, their first sides 132a, 132b, and perforations 136a, 136b, and openings 318 of the first encapsulation layer 310. The dashed lines indicating the colorimetric analyte sensing elements 130a, 130b also outline the individual pockets 333 (one of two shown in FIG. 6) that are formed when the first encapsulation layer 310 and the second encapsulation layer 330 are sealed together where their surfaces contact.

[0064] When assembled, first perforation 336 in second encapsulation layer 330 is aligned with perforations 136a, 136b in colorimetric analyte sensing elements 130a, 130b, as well as perforation 316 (not shown) in first encapsulation layer 310. Additionally, opening 338 in second encapsulation layer 330 is aligned with opening 318 in first encapsulation layer 310.

[0065] A fluid-impermeable envelope 331 encapsulating the colorimetric analyte sensing elements 130a, 130b of the indicator component 120 of the system 100 is disposed on the fluid transfer layer 150. This partially assembled indicator component of the system 100 is shown in a top view in FIG. 7 and a bottom view in FIG. 8. FIG. 7 shows, in solid lines, the first side 152, first perforation 156, and second perforation 158 of the fluid transfer layer 150. In dashed lines, the figure shows the colorimetric analyte sensing elements 130a, 130b, their first sides 132a, 132b, and perforations 136a, 136b, as well as the opening 318 of the first encapsulation layer 310 and the first side 332 and opening 338 of the second encapsulation layer 330.

[0066] 8 shows, in solid lines, second side 154 of fluid transport layer 150, as well as second side 314, perforation 316, and opening 318 of first encapsulation layer 310. In dashed lines, the figure shows colorimetric analyte sensing elements 130a, 130b, their second sides 134a, 134b, and perforations 136a, 136b, as well as second perforation 158 of fluid transport layer 150.

[0067] Second flexible web 140 has first side 142, second side 144, and opening 146, and is made of a non-absorbent material such as polyethylene foam. A fluid impermeable envelope 331 encapsulating colorimetric analyte sensing elements 130a, 130b is disposed on second flexible web 140, specifically within opening 146 of second flexible web 140, and is in fluid communication with fluid transfer layer 150. Fluid transfer layer 150 is in turn in fluid communication with first flexible web 160. First flexible web 160 has first side 162 and perforations 166, and is made of a non-absorbent apertured film such as polyethylene mesh.

[0068] Second flexible web 140, fluid transfer layer 150, and first flexible web 160 are designed to control the transport of bodily fluids to the colorimetric analyte sensing elements 130a, 130b and to limit fluid cross-contamination between different colorimetric analyte sensing elements. During use, fluid from the absorbent article first contacts first side 162 of first flexible web 160. Because first flexible web 160 is a non-absorbent apertured film, the fluid passes through first flexible web 160 and contacts first side 152 of fluid transfer layer 150. The fluid then permeates throughout the fluid transfer layer 150. The fluid will contact first side 142 of second flexible web 140. However, because second flexible web 140 is made of a non-absorbent material, the fluid in fluid transfer layer 150 does not penetrate second flexible web 140. Finally, the fluid in the transport layer 150 passes through the openings 338 in the second encapsulation layer 330 and contacts the colorimetric analyte sensing elements 130a, 130b. Cross-contamination between the two colorimetric analyte sensing elements is eliminated, or at least rendered unnoticeable or undetectable, with the fluid barrier defined by the capillary gap in the fluid transport layer 150 provided by the second perforations 158.

[0069] Colorimetric analyte sensing elements 130a, 130b, first encapsulation layer 310, second encapsulation layer 330, second flexible web 140, fluid transfer layer 150, and first flexible web 160 are stacked as shown in FIG. 4 and held together by top plate 170 and retaining plate 180. Top plate 170 has pins 178 that pass sequentially through perforation 166 in first flexible web 160, first perforation 156 in fluid transfer layer 150, perforation 316 in first encapsulation layer 310, perforations 136a, 136b in colorimetric analyte sensing elements 130a, 130b, first perforation 336 in second encapsulation layer 330, opening 146 in second flexible web 140, and finally positioned within blind holes 186 in retaining plate 180. A friction fit between the top plate pins 178 and the blind holes 186 holds together the components of the indicator component 120. Alternative assemblies may be held together by other interactions such as snap fits, ultrasonic welding, heat welding, other mechanical fasteners, and the like.

[0070] The top plate 170 may have one or more channels on the side facing the first side 162 of the first flexible web 160. The channels may help direct fluid from the absorbent article to the first side 162 of the first flexible web 160.

[0071] The indicator component 120 may have an attachment means such as an adhesive layer 190. The adhesive layer 190 has a first side 192 and a second side 194 and is used to attach or bond the indicator component 120 of the system 100 to a fluid transfer layer of an absorbent article such as a diaper.

[0072] The durable component 200 of the system is shown in a top perspective view in FIG. 9 and a top view in FIG. 10. The durable component 200 has a housing 202 with a pair of windows, first window 204a and second window 204b. The durable component 200 also has a flat top surface 206. A pair of spectrophotometers are disposed within the housing 202. The first spectrophotometer is adjacent to and in optical communication with the first window 204a. The first spectrophotometer components include a light source 222a and a photodetector 224a. The first spectrophotometer is in optical communication with the colorimetric analyte sensing element 130a. The second spectrophotometer is adjacent to and in optical communication with the second window 204b. The second spectrophotometer components include a light source 222b and a photodetector 224b. The second spectrophotometer is in optical communication with the colorimetric analyte sensing element 130b. Although the durable component 200 is shown with two spectrophotometers, additional spectrophotometers may be included for measuring additional analytes or bodily fluid conditions, such as pH, temperature, etc. The indicator-zone 121 is the area of ​​the indicator component 120 where the colorimetric analyte sensing element 130a is exposed to the light source 222a.

[0073] Although not shown, durable component 200 also includes a printed circuit board (PCB) with a computing system having one or more processors and memory, as well as a means for electronic communication to transmit the results of the analysis to a data processing system external to system 100. Data processing systems that may be used include at least one external device, including a server computer, a client computer, and a handheld device such as a mobile phone.

[0074] As shown in Figures 9 and 10, the first and second spectrophotometers may include four light sources 222a, 222b, each having one photodetector 224a, 224b. Each spectrophotometer may have at least one light source 222a, 222b associated therewith. Each spectrophotometer may include at least six or more light sources 222a, 222b. As mentioned above, the light sources 222a, 222b may be light-emitting diodes (LEDs), more specifically, RGB LEDs. The light sources 222a, 222b may sequentially emit red, green, and blue light, allowing for near-simultaneous collection of three data points, or the order of the emitted red, green, and blue light may be varied.

[0075] As previously discussed, the photodetectors 224a, 224b in the spectrophotometer may specifically measure red, green, and blue light, allowing data to be acquired within a narrow wavelength range. Light waves emitted from the light source 222a reflect off the colorimetric analyte sensing element 130a, and the reflected light is quantified by the photodetector 224a. Light waves emitted from the light source 222b reflect off the colorimetric analyte sensing element 130b, and the reflected light is quantified by the photodetector 224b. The components of the spectrophotometer may be coated with a protective material. The protective material prevents moisture from the colorimetric analyte sensing elements 130a, 130b from contacting and potentially damaging the components of the spectrophotometer.

[0076] 9 and 10 also show connector 210 disposed on housing 202. Connector 210 includes a standard spring-loaded clip 212 that is biased to retain clip 212 to housing 202 of durable component 200. As shown in FIG. 4, retention plate 180 has receiving element 184 disposed thereon. Clip 212 is fastened to receiving element 184 to releasably attach durable component 200 to retention plate 180. By this means, durable component 200 is releasably attached to indicator component 120. Other attachment means will be readily apparent, including, but not limited to, clips, clamps, hook-and-loop systems, threaded openings, bayonet couplings, mechanical fasteners such as straps, belts, and bands, magnetic (including electrostatic), friction, and the like.

[0077] 9 and 10 also show a reservoir retriever 250 disposed on the housing 202 of the durable component 200. The reservoir retriever 250 has an opening 252 that is used to retrieve the fluid collection reservoir 185 from the retaining plate 180, as described below.

[0078] 10 also shows conductive strips 208a, 208b, 208c, and 208d disposed on the top surface 206 of the durable component 200. The conductive strips 208a, 208b, 208c, and 208d act as moisture sensors arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing elements 130a, 130b to a computing system disposed within the durable component 200. As shown in FIG. 10, the conductive strips 208a and 208b are associated with the first window 204a and the colorimetric analyte sensing element 130a. The conductive strips 208c and 208d are associated with the second window 204b and the colorimetric analyte sensing element 130b. The computing system disposed within the durable component 200 is operably connected to the moisture sensors and the components of the spectrophotometer.

[0079] Conductive strips 208a and 208b are adjacent to colorimetric analyte sensing element 130a. When moisture impinges on colorimetric analyte sensing element 130a, it will also contact portions of conductive strips 208a and 208b. Conductive strips 208c and 208d are adjacent to colorimetric analyte sensing element 130b. When moisture impinges on colorimetric analyte sensing element 130b, it will also contact portions of conductive strips 208c and 208d.

[0080] 13 and 14 illustrate the function of conductive strips 208a and 208b in the moisture sensor in system 100. Conductive strips 208c and 208d function similarly. FIG. 13 shows top views of conductive strips 208a and 208b at several points during the progress of a moisture front across the strips. The progress of the front is indicated as AA, BB, CC, and DD. At point AA, the moisture front has progressed partially across conductive strips 208a and 208b. Further progress across strips 208a and 208b is indicated as points BB and CC, while DD indicates the point at which the moisture front has completely traversed strips 208a and 208b.

[0081] Although capacitance has been discussed above, other electrical properties, such as resistance, will also change as the moisture front progresses across strips 208a and 208b.

[0082] FIG. 14 shows an example of the change in electrical properties between strips 208a and 208b as the moisture front progresses across the strips. This figure shows a capacitance versus time plot as the moisture front traverses strips 208a and 208b. Line A on FIG. 14 corresponds to time AA, when the moisture front has progressed partially across conductive strips 208a and 208b. The capacitance is shown to increase to line B and then line C, as time points BB and CC indicate further progress across strips 208a and 208b. Finally, the capacitance is shown to reach a level corresponding to time point DD, when the moisture front has completely traversed strips 208a and 208b, line D. At point DD, the colorimetric analyte sensing element 130 is fully saturated with moisture.

[0083] As described above, the system 100 for measuring analyte concentrations in absorbent articles uses colorimetric analyte sensing elements 130a, 130b to generate a visual indication of the presence of a preselected analyte in a sample newly generated by the wearer of the system 100. The system 100 also includes a means for collecting fluid for later analysis. The retention plate 180 includes a fluid collection reservoir 185 attached to the retention plate 180 by a reservoir connector 183. The fluid collection reservoir 185 may comprise an absorbent material, such as a sponge, for collecting bodily fluids, such as urine. Fluid collected by the fluid collection reservoir 185 can be sent to a comprehensive testing site to compare the concentrations determined by the colorimetric analyte sensing elements 130a, 130b with concentrations determined by a "gold standard" testing method. Tests can also be performed for other analytes not measured by the colorimetric analyte sensing elements 130a, 130b to provide a more comprehensive assessment of the user's health.

[0084] 11 and 12 show the connection between the durable component 200 and the fluid collection reservoir 185. As described above, the fluid collection reservoir 185 is attached to the retaining plate 180 by the reservoir connector 183. FIG. 11 is a partial side view of the system 100, while FIG. 12 is a partial top perspective view of the indicator component 120. FIG. 11 shows the fluid collection reservoir 185 positioned within an opening 252 of a reservoir retriever 250. When the durable component 200 is removed from the retaining plate 180, the reservoir retriever 250 removes the fluid collection reservoir 185 from the retaining plate 180.

[0085] 12 shows a retaining plate 180 having a fluid collection reservoir 185 attached to the retaining plate 180 by a reservoir connector 183. The fluid collection reservoir 185 may have a twist-off feature 188 to aid in its removal from the bottom side 182 of the retaining plate 180.

[0086] The system for measuring analyte concentrations in bodily fluids may be used in an absorbent article or may be directly contacted by bodily fluids outside of the absorbent article. For example, the system may contact bodily fluids collected in a specimen container or may contact bodily fluids such as urine as the fluid is excreted from the human body. FIGS. 15-17 illustrate a system for measuring analyte concentrations in bodily fluids of the present invention. System 500 includes an indicator component 520 and a durable component 600. FIG. 15 is a top perspective view of system 500 when fully assembled. FIG. 16 is a top perspective view of indicator component 520 of system 500. FIG. 17 is a partially exploded view of system 500, with indicator component 520 shown in exploded view.

[0087] 17, indicator component 520 includes indicator zone 521, which is shown to have a pair of colorimetric analyte sensing elements, namely, first colorimetric analyte sensing element 530a and second colorimetric analyte sensing element 530b. First colorimetric analyte sensing element 530a has a first side 532a and perforations 536a. Second colorimetric analyte sensing element 530b has a first side 532b and perforations 536b.

[0088] As previously discussed, the colorimetric analyte sensing elements 530a, 530b may be reagent-impregnated matrices designed to produce a visual indication of the presence of a preselected analyte in a sample generated by a user of the system 500. The preselected analytes measured by the system 500 may be glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, among others.

[0089] Again, the colorimetric analyte sensing elements 530a, 530b may be designed to indicate the presence of the same preselected analyte in samples generated by a user of the system 500. In this case, the colorimetric analyte sensing elements 530a, 530b act to confirm the analysis. The colorimetric analyte sensing elements 530a, 530b may also be designed to produce a visual indication of the presence of different preselected analytes in samples generated by a user of the system 500.

[0090] Again, the fluid being tested may be urine, and the preselected analytes measured by system 500 may be glucose, one or more ketones, or a combination thereof. The presence of higher than normal levels of glucose and / or ketones in the urine may be due to a complication with the user's kidneys or other conditions, such as diabetes mellitus, hyperthyroidism, benign diabetes, cirrhosis of the liver, or a high carbohydrate diet.

[0091] Additionally, selecting an appropriate biosensor capable of converting a preferred biomarker into a calorimetrically readable result can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers present in urine or other bodily fluids.

[0092] Other components of the indicator component 520 include a top plate 570, a first flexible web 560, a fluid transfer layer 550, a first encapsulation layer 710, a second encapsulation layer 730, and a coupler 580, shown here as a retaining plate.

[0093] The colorimetric analyte sensing elements 530a, 530b are encapsulated between a first encapsulation layer 710 and a second encapsulation layer 730 to form a fluid-impermeable envelope 731. The first encapsulation layer 710 has a first side 712, a perforation 716, and an opening 718. The second encapsulation layer 730 has a first side 732, a perforation 736, and an opening 738.

[0094] When assembled into indicator component 520, perforations 716 in first encapsulation layer 710 are aligned with perforations 536a, 536b in colorimetric analyte sensing elements 530a, 530b and perforation 736 in second encapsulation layer 730. Additionally, opening 718 in first encapsulation layer 710 is aligned with opening 738 in second encapsulation layer 730.

[0095] 17 also shows a fluid transfer layer 550 and a first flexible web 560. When assembled into the indicator component 520, the fluid transfer layer 550 is disposed over the encapsulated colorimetric analyte sensing elements 530a, 530b of the indicator component 520 of the system 500. The fluid transfer layer 550 has a first side 552, a first perforation 556, and a second perforation 558. The first flexible web 560 is disposed over the fluid transfer layer 550 and has a first side 562 and perforations 566, and is made from a non-absorbent apertured film such as a polyethylene mesh.

[0096] When assembled into indicator component 520, colorimetric analyte sensing elements 230a, 230b, which are encapsulated in fluid impermeable envelope 731, are in fluid communication with fluid transport layer 550. Fluid transport layer 550 is in turn in fluid communication with first flexible web 560.

[0097] Fluid transport layer 550 and first flexible web 560 are designed to control the transport of bodily fluid to colorimetric analyte sensing elements 530a, 530b and to limit fluid cross-contamination between different colorimetric analyte sensing elements. During use, bodily fluid first contacts first side 562 of first flexible web 560. Because first flexible web 560 is a non-absorbent apertured film, the fluid passes through first flexible web 560 and contacts first side 552 of fluid transport layer 550. The fluid then permeates throughout fluid transport layer 550. Finally, the fluid in transport layer 550 passes through apertures 738 in second encapsulation layer 730 to contact colorimetric analyte sensing elements 530a, 530b. Again, cross-contamination between the two colorimetric analyte sensing elements is eliminated, or at least rendered unnoticeable and undetectable, with the fluid barrier defined by the gap in capillarity within the fluid transport layer 550 provided by the second perforations 558.

[0098] Sensing elements 530a, 530b, first encapsulation layer 710, second encapsulation layer 730, fluid transfer layer 550, and first flexible web 560 are stacked as shown in FIG. 17 and held together by top plate 570 and retaining plate 580. Top plate 570 has pin 578 that passes through perforation 566 in first flexible web 560, first perforation 556 in fluid transfer layer 550, perforation 716 in first encapsulation layer 710, perforations 536a, 536b in colorimetric analyte sensing elements 530a, 530b, perforation 736 in second encapsulation layer 730, and finally disposed in blind hole 586 on first side 582 of retaining plate 580. A friction fit between the top plate pin 578 and the blind hole 586 holds together the components of the indicator component 520. Alternative assemblies may be held together by other interactions such as snap fits, ultrasonic welding, heat welding, other mechanical fasteners, and the like.

[0099] Top plate 570 has openings 576 that help direct fluid to first side 562 of first flexible web 560. Top plate 570 also has protrusions 575 disposed thereon. Protrusions 575, and protrusions 587 disposed on retainer plate 580, are a means of attaching indicator component 520 to durable component 600 of system 500.

[0100] The system 500 also includes a means for collecting fluid for later analysis. The retaining plate 580 has a first side 572 and a fluid collection reservoir 595 attached to the top plate 570 by a reservoir connector 590. The fluid collection reservoir 595 may comprise an absorbent material, such as a sponge, to collect bodily fluids, such as urine. Fluid collected by the fluid collection reservoir 185 can be sent to a comprehensive testing site to compare the concentrations determined by the colorimetric analyte sensing elements 530a, 530b with concentrations determined by a "gold standard" testing method. Tests can also be performed for other analytes not measured by the colorimetric analyte sensing elements 530a, 530b to provide a more comprehensive determination of the user's health. The fluid collection reservoir 595 is detached from the top plate 570 by snapping the reservoir connector 590.

[0101] Durable component 600 is shown in a top perspective view in FIG. 17. Durable component 600, having a proximal end 620 and a distal end 630, has a housing 602 with a pair of windows, first window 604a and second window 604b. Durable component 600 also has a flat top surface 606, conductive strips 608a and 608b, a receiving element 605, a protrusion 610, an activation button 650, and a finger grip 660. First window 604a and second window 604b align with opening 585 in retainer plate 580.

[0102] Although not shown, a pair of spectrophotometers are disposed within the housing 602. The first spectrophotometer is adjacent to and in optical communication with the first window 604a, while the second spectrophotometer is adjacent to and in optical communication with the second window 604b. The first spectrophotometer is in optical communication with the colorimetric analyte sensing element 530a, and the second spectrophotometer is in optical communication with the colorimetric analyte sensing element 530b. Although the durable component 600 is shown with two spectrophotometers, additional spectrophotometers may be included for measuring additional analytes or bodily fluid conditions, such as pH or temperature. The indicator zone 521 is the area of ​​the indicator component 520 where the colorimetric analyte sensing element 530a is exposed to a light source.

[0103] Although not shown, durable component 600 also includes a printed circuit board (PCB) with a computing system having one or more processors and memory, as well as a means for electronic communication to transmit the results of the analysis to a data processing system external to system 500. Data processing systems that may be used include at least one external device, including a server computer, a client computer, and a handheld device such as a mobile phone.

[0104] As discussed elsewhere herein, a spectrophotometer may include at least one or more, or two or more, or four or more, or six or more light sources and at least one, or at least two or more photodetectors. Also, as previously mentioned, the light sources in durability component 600 may be light emitting diodes (LEDs), more specifically, RGB LEDs. The light sources may emit red, green, and blue light sequentially, allowing for near-simultaneous collection of three data points, or the order of the emitted red, green, and blue light may be varied.

[0105] The photodetectors in the durable components 600 may also specifically measure red, green, and blue light, as previously discussed, allowing data to be acquired within a narrow wavelength range, and may be coated with a protective material to reduce the possibility of damage to those components.

[0106] 15 shows a top perspective view of durable component 600 and indicator component 520 assembled to form system 500. Here, indicator component 520 is disposed on distal end 630 of durable component 600. Top plate 570 of durable component 600 has protrusion 575, and retention plate 580 has protrusion 587. Durable component 600 has receiving element 605 and protrusion 610. To releasably attach indicator component 520 to durable component 600, protrusion 575 of top plate 570 is disposed within receiving element 605 of durable component 600. Protrusion 587 of retention plate 580 is then engaged with protrusion 610 of durable component 600 using a snap connection.

[0107] 17 shows conductive strips 608a and 608b disposed on the top surface 606 of the durable component 600. The conductive strips 608a and 608b act as moisture sensors for the system 500. They are arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing elements 530a, 530b to a computing system disposed within the durable component 600. As shown, the conductive strip 608a is associated with the first window 604a and the colorimetric analyte sensing element 530a. The conductive strip 608b is associated with the second window 604b and the colorimetric analyte sensing element 530b. The computing system disposed within the durable component 600 is operably connected to the moisture sensors and the spectrophotometer components.

[0108] The mode of operation of conductive strips 608a and 608b as moisture sensors is identical to the operation of conductive strips 208a and 208b as described in Figures 13 and 14. A moisture front progresses partially and eventually completely across conductive strips 608a and 608b.

[0109] The durable component may be matched with multiple indicator components to create a kit for measuring analyte concentrations in absorbent articles. For example, a kit may have durable component 200 or 600 (described above) and multiple indicator components 120, 520 (also described above). To ensure the integrity of the indicator components during storage, each such indicator component is enclosed within an individual package.

[0110] The present invention also includes a method for measuring an analyte concentration in an absorbent article. Bodily fluid is collected and transported to at least one colorimetric analyte sensing element via a transport layer. The presence of bodily fluid at the at least one colorimetric analyte sensing element initiates a countdown over a predetermined period of time. Optical data associated with the colorimetric analyte sensing element is collected by at least one spectrophotometer after the predetermined period of time. The optical data is communicated to a computing system having at least one processor and data storage device. The optical data is analyzed to determine the concentration of at least one analyte in the bodily fluid.

[0111] The predetermined period of time following bodily fluid contact with the colorimetric analyte sensing element can be greater than 15 seconds, or greater than 30 seconds, or greater than 60 seconds, or greater than 120 seconds, or greater than 240 seconds, or greater than 300 seconds, or greater than 360 seconds, or longer. The predetermined period of time following bodily fluid contact with the colorimetric analyte sensing element can be a predetermined time range of, for example, from about 15 to about 360 seconds, or from about 30 to about 240 seconds, or from about 120 to about 180 seconds, or from about 240 to about 360 seconds.

[0112] The analytes measured by the system may be glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, among others.

[0113] Analytes found in bodily fluids potentially carry evidence of developing metabolic problems. There is a need for those within and outside of medical facilities to track and analyze changes in the concentrations of analytes in bodily fluids over time. These changes can be useful for predicting the risk of future disease states. Thus, the system contemplated in this invention enables a method for predicting the risk of future disease states.

[0114] As described above, bodily fluid is collected and transported to at least one colorimetric analyte sensing element via a transport layer. The presence of bodily fluid at the at least one colorimetric analyte sensing element initiates a countdown over a predetermined period of time. Optical data associated with the colorimetric analyte sensing element is collected by at least one spectrophotometer after the predetermined period of time. The optical data is communicated to a computing system having at least one processor and data storage device. The optical data is analyzed to determine the concentration of at least one analyte in the bodily fluid. A threshold analyte concentration of the at least one analyte concentration indicative of a risk of developing a future disease state is compared to the at least one analyte concentration, which can be recorded over time. Thus, the risk of developing a future disease state can be monitored over time.

[0115] The system may be arranged, configured, and programmed with multiple photodetectors 124 and multiple colorimetric analyte sensing elements 30 to determine multiple analyte concentrations in a bodily fluid.

[0116] Noninvasively measuring analyte concentrations in bodily fluids is also ideally suited for epidemiological studies to quickly identify common problems in a particular region or for specific populations. Analyte concentration measurements from system 10 can be collected over long periods of time across broad populations. The collected data can be studied to determine relationships between various analyte levels and disease states, or combined with other physiological parameters such as blood pressure, blood oxygen levels, and pulse rate, or with demographic statistics such as age, sex, weight, and nationality, to create predictive models of future disease states as a function of the stored parameters.

[0117] The aforementioned methods may employ a system deployed within or in conjunction with an absorbent article, such as a diaper or pad, or may employ direct contact with bodily fluids without the use of an absorbent article. For example, the system 500 may be attached to the body-facing surface of a diaper. The system 500 of FIGS. 15-17 may be in direct contact with bodily fluids. It may be immersed in the bodily fluid to be initially collected in a specimen container by grasping the system 500 by the finger grip 660 on the proximal end 620 of the durable component 600. The system 500 may be energized by a user-interacting activation button 650 on the proximal end 620 of the durable component 600 before or after placing the distal end 630 into the specimen container. Alternatively, the indicator component of the system 500 may be placed in a stream of bodily fluid, such as urine, as the fluid is discharged from the human body. In these uses, the durable component 600 is a handheld analyzer.

[0118] The above specification, embodiments, and examples are presented to aid in a complete and non-limiting understanding of the invention disclosed herein. Since many variations and embodiments of the invention are possible without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

[0119] [Embodiment] (1) A system for determining an analyte concentration in a body fluid, comprising: a) a durable component comprising a housing having at least one window, i) at least one spectrophotometer adjacent to and in optical communication with said window; ii) a computing system having at least one processor and a data storage device; iii) a durable component housing a means for electronic communication between said computing system and at least one external device; b) an indicator component comprising an indicator zone comprising at least one colorimetric analyte sensing element and a fluid transfer layer in fluid communication with said indicator zone; c) at least one moisture sensor adjacent to said indicator zone; d) a fluid collection reservoir having a fluid impermeable wall and a port in fluid communication with the fluid transfer layer, the fluid collection reservoir being releasable from at least one of the indicator component and the durable component at a predetermined break point; I) the indicator component is arranged and configured to be attached to the durable component while the indicator zone is disposed adjacent to and in optical communication with the at least one window and the at least one spectrophotometer; II) the computing system is operably connected to the moisture sensor and the at least one spectrophotometer; III) the moisture sensor is arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to the computing system; IV) each of said at least one colorimetric analyte sensing element is associated with a spectrophotometer; V) A system wherein the fluid collection reservoir is arranged and configured to provide a fluid transport gradient for drawing the bodily fluid therein and is sealable when detached from the indicator component. (2) The system of embodiment 1, wherein the indicator component comprises at least two colorimetric analyte sensing elements, each of the at least two colorimetric sensing elements being isolated from the other colorimetric sensing elements, and further comprising a fluid-impermeable envelope surrounding the indicator zone, the fluid-impermeable envelope having individual pockets arranged or configured to accommodate each of the at least two colorimetric sensing elements, each pocket having its own opening in fluid communication with the fluid transport layer. (3) The indicator component comprises: i) a top plate; ii) a first flexible web layer; and iii) a fluid transfer layer adjacent to the first flexible web layer; and iv) a fluid impermeable envelope surrounding the indicator zone adjacent the fluid transfer layer; v) a second flexible web layer adjacent to the fluid impermeable envelope; vi) attachment means disposed on said second flexible web layer; vii) a retaining plate; VI) the first flexible web layer, the fluid transfer layer, the fluid impermeable envelope, and the second flexible web layer are stacked in order and secured between the top plate and the support plate; VII) the indicator zone comprises at least two colorimetric analyte sensing elements; VIII) the fluid-impermeable envelope has a separate pocket arranged or configured to accommodate each of the at least two colorimetric analyte sensing elements, each pocket having a unique opening in fluid communication with the fluid transfer layer; IX) the fluid transfer layer is arranged and configured to prevent fluid transfer between openings in the fluid impermeable envelope; X) The system of embodiment 1, wherein the fluid collection reservoir is releasably attached to the retaining plate. (4) The system of embodiment 1, wherein the fluid collection reservoir further comprises an absorbent structure contained by the fluid-impermeable wall. (5) The system of embodiment 1, wherein the indicator component is releasably attached to the durable component.

[0120] (6) The system of embodiment 1, arranged and configured to be placed in a diaper. (7) A handheld device comprising the system described in embodiment 1. (8) A kit comprising the system of embodiment 1 and an additional indicator component, wherein each indicator component and the additional indicator component are each enclosed in an individual package. (9) A method for determining an analyte concentration in a body fluid, comprising: a) collecting and transporting a bodily fluid to at least one fluid collection reservoir having at least one colorimetric analyte sensing element and a fluid-impermeable wall and port; b) detecting the presence of a bodily fluid in contact with said at least one colorimetric analyte sensing element; and c) collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer after a predetermined period of time after detecting the presence of bodily fluid in contact with the colorimetric analyte sensing element; d) communicating the optical data to a computing system having at least one processor and a data storage device; e) analyzing the optical data to determine the concentration of at least one analyte in the bodily fluid; f) sealing the fluid collection reservoir for transport of the sealed fluid collection reservoir to a laboratory for laboratory analysis. (10) The method of embodiment 9, wherein the body fluid is urine.

[0121] 11. The method of claim 10, wherein the analyte is selected from the group consisting of glucose, ketones, bilirubin, blood, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, and combinations thereof. (12) The method of claim 9, further comprising the step of: g) instructing the laboratory to analyze the bodily fluid for the at least one analyte; and comparing the concentration of the at least one analyte from step e) and the laboratory analysis. (13) The method of embodiment 9, further comprising the step of: (x) instructing the laboratory to analyze a panel comprising a plurality of biomarkers. (14) The method of embodiment 13, wherein the panel comprising a plurality of biomarkers comprises the at least one analyte. (15) A method for determining an analyte concentration in a body fluid, comprising: a) obtaining a durable component comprising a housing having at least one window, said durable component comprising: i) at least one spectrophotometer adjacent to and in optical communication with said window; ii) a computing system having at least one processor and a data storage device; iii) means for electronic communication between said computing system and at least one external device; and iv) receiving at least one moisture sensor; b) removing an indicator component from an individual package, the indicator component comprising: (i) an indicator zone comprising at least one colorimetric analyte sensing element; (ii) a fluid transfer layer in fluid communication with the indicator zone; and (iii) a fluid collection reservoir having a fluid-impermeable wall and a port in fluid communication with the fluid transfer layer, the fluid collection reservoir being releasable from the indicator component at a predetermined break point; c) coupling the indicator component to the durable component, I) the indicator zone is disposed adjacent to and in optical communication with the at least one window and the at least one spectrophotometer; II) the computing system is operably connected to the moisture sensor and the at least one spectrophotometer; III) the moisture sensor is positioned adjacent to the indicator zone; IV) each of said at least one colorimetric analyte sensing element is associated with a spectrophotometer; V) coupling the fluid collection reservoir arranged and configured to provide a fluid transport gradient for drawing the bodily fluid therein and sealable when detached from the indicator component; d) placing the assembled device in contact with a source of said bodily fluid; e) collecting and transporting said bodily fluid to said at least one colorimetric analyte sensing element and said fluid collection reservoir; f) detecting the presence of said bodily fluid in contact with said at least one colorimetric analyte sensing element; g) collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer after a predetermined period of time after detecting the presence of bodily fluid in contact with the colorimetric analyte sensing element; h) communicating the optical data to a computing system having at least one processor and a data storage device; i) analyzing the optical data to determine the concentration of at least one analyte in the bodily fluid; j) removing the fluid collection reservoir from the indicator component; k) sealing the fluid collection reservoir port for transport of the sealed fluid collection reservoir to a laboratory for laboratory analysis.

[0122] 16. The method of claim 15, wherein step (d) comprises attaching the assembled device to a body-facing surface of a diaper. 17. The method of claim 15, wherein step (d) comprises contacting the assembled device with the bodily fluid. (18) The method of claim 15, further comprising the step of: l) instructing the laboratory to analyze the bodily fluid for the at least one analyte; and comparing the concentration of the at least one analyte from step i) and the laboratory analysis. (19) The method of embodiment 15, further comprising the step of: x) instructing the laboratory to analyze a panel comprising a plurality of biomarkers. (20) The method of embodiment 19, wherein the panel comprising a plurality of biomarkers comprises the at least one analyte.

Claims

1. 1. A system for measuring an analyte concentration in a body fluid, comprising: a) a durable component comprising a housing having at least one window, i) at least one spectrophotometer adjacent to and in optical communication with said window; ii) a computing system having at least one processor and a data storage device; iii) a durable component housing a means for electronic communication between said computing system and at least one external device; b) an indicator component comprising an indicator zone comprising at least one colorimetric analyte sensing element and a fluid transfer layer in fluid communication with said indicator zone; c) at least one moisture sensor adjacent to said indicator zone; d) a fluid collection reservoir having a fluid impermeable wall and a port in fluid communication with the fluid transfer layer, the fluid collection reservoir being releasable from at least one of the indicator component and the durable component at a predetermined break point; I) the indicator component is arranged and configured to be attached to the durable component while the indicator zone is disposed adjacent to and in optical communication with the at least one window and the at least one spectrophotometer; II) the computing system is operably connected to the moisture sensor and the at least one spectrophotometer; III) the moisture sensor is arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to the computing system; IV) each of said at least one colorimetric analyte sensing element is associated with a spectrophotometer; V) A system wherein the fluid collection reservoir is arranged and configured to provide a fluid transport gradient for drawing the bodily fluid therein and is sealable when detached from the indicator component.

2. 2. The system of claim 1, wherein the indicator component comprises at least two colorimetric analyte sensing elements, each of the at least two colorimetric analyte sensing elements being isolated from the other colorimetric sensing elements, and further comprises a fluid-impermeable envelope surrounding the indicator zone, the fluid-impermeable envelope having individual pockets arranged or configured to accommodate each of the at least two colorimetric analyte sensing elements, each pocket having its own opening in fluid communication with the fluid transfer layer.

3. the indicator component comprises: i) a top plate; ii) a first flexible web layer; and iii) a fluid transfer layer adjacent to the first flexible web layer; and iv) a fluid impermeable envelope surrounding the indicator zone adjacent the fluid transfer layer; v) a second flexible web layer adjacent said fluid impermeable envelope; vi) attachment means disposed on said second flexible web layer; vii) a retaining plate; VI) the first flexible web layer, the fluid transfer layer, the fluid impermeable envelope, and the second flexible web layer are stacked in order and secured between the top plate and the support plate; VII) the indicator zone comprises at least two colorimetric analyte sensing elements; VIII) the fluid-impermeable envelope has a separate pocket arranged or configured to accommodate each of the at least two colorimetric analyte sensing elements, each pocket having a unique opening in fluid communication with the fluid transport layer; IX) the fluid transfer layer is arranged and configured to prevent fluid transfer between openings in the fluid impermeable envelope; X) The system of claim 1, wherein said fluid collection reservoir is releasably attached to said retainer plate.

4. The system of claim 1 , wherein the fluid collection reservoir further comprises an absorbent structure contained by the fluid impermeable wall.

5. The system of claim 1 , wherein the indicator component is releasably attached to the durable component.

6. 10. The system of claim 1 arranged and configured to be placed into a diaper.

7. A handheld device comprising the system of claim 1.

8. 10. A kit comprising the system of claim 1 and an additional indicator component, wherein the indicator component and the additional indicator component are each enclosed within individual packages.

9. 1. A method for determining an analyte concentration in a body fluid, comprising: a) obtaining a durable component comprising a housing having at least one window, said durable component comprising: i) at least one spectrophotometer adjacent to and in optical communication with said window; ii) a computing system having at least one processor and a data storage device; iii) means for electronic communication between said computing system and at least one external device; and iv) at least one moisture sensor; b) removing an indicator component from an individual package, the indicator component comprising: (i) an indicator zone comprising at least one colorimetric analyte sensing element; (ii) a fluid transfer layer in fluid communication with the indicator zone; and (iii) a fluid collection reservoir having a fluid-impermeable wall and a port in fluid communication with the fluid transfer layer, the fluid collection reservoir being releasable from the indicator component at a predetermined break point; c) coupling the indicator component to the durable component; I) the indicator zone is disposed adjacent to and in optical communication with the at least one window and the at least one spectrophotometer; II) the computing system is operably connected to the moisture sensor and the at least one spectrophotometer; III) the moisture sensor is positioned adjacent to the indicator zone; IV) each of said at least one colorimetric analyte sensing element is associated with a spectrophotometer; V) coupling the fluid collection reservoir arranged and configured to provide a fluid transport gradient for drawing the bodily fluid therein and sealable when detached from the indicator component; d) placing the assembled device in contact with a source of said bodily fluid; e) collecting and transporting the bodily fluid to the at least one colorimetric analyte sensing element and the fluid collection reservoir; f) detecting the presence of said bodily fluid in contact with said at least one colorimetric analyte sensing element; g) collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer after a predetermined period of time after detecting the presence of the bodily fluid in contact with the colorimetric analyte sensing element; h) communicating the optical data to a computing system having at least one processor and a data storage device; i) analyzing the optical data to determine the concentration of at least one analyte in the bodily fluid; j) removing the fluid collection reservoir from the indicator component; k) sealing the port of the fluid collection reservoir for transport of the sealed fluid collection reservoir to a laboratory for laboratory analysis.

10. 10. The method of claim 9, wherein step (d) comprises attaching the assembled device to a body-facing surface of a diaper.

11. 10. The method of claim 9, wherein step (d) comprises contacting the assembled device with the bodily fluid.

12. 10. The method of claim 9, further comprising the step of: l) instructing the laboratory to analyze the bodily fluid for the at least one analyte; and comparing the concentration of the at least one analyte from step i) and the laboratory analysis.

13. 10. The method of claim 9, further comprising the step of: x) instructing the laboratory to analyze a panel comprising a plurality of biomarkers.

14. The method described in claim 13, wherein the panel comprising the plurality of biomarkers comprises the at least one analyte.

Images