System and method for measuring analyte concentration in bodily fluids

Abstract

To provide a system and a method for measuring analyte concentration in bodily fluids.SOLUTION: A system includes durable components, at least one indicator component comprising an indicator zone, and at least one moisture sensor. A method for measuring analyte concentration in bodily fluids and predicting future health risks comprises: collecting bodily fluid and transporting it to at least one colorimetric analyte sensing element; detecting the presence of bodily fluid in contact with the at least one colorimetric analyte sensing element; after a predetermined period following detection of the bodily fluid, collecting optical data relating to the at least one colorimetric analyte sensing element using at least one spectrophotometer; communicating the optical data to a computing system having at least one processor and data storage; and analyzing the optical data to determine at least one analyte concentration in the bodily fluid.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a system for measuring changes in the concentration of an analyte in a body fluid. More specifically, the present invention relates to a system used for measuring the concentration of an analyte in urine over time, and a method for measuring these analytes and detecting early-onset disease states in the human body.

Background Art

[0002] Analytes found in body fluids such as urine or sweat potentially carry evidence of metabolic problems. There is a need for people inside and outside medical facilities to track and analyze changes in the concentration of analytes in body fluids over time.

[0003] Currently, people and physicians rely on visible symptoms to diagnose systemic metabolic problems. This often prompts physicians to perform urine analysis or blood tests to determine the presence or concentration of various analytes in these body fluids. Thus, in today's practice, tests such as urine analysis are most frequently used not for early identification of diseases, but to confirm symptom-based diagnoses. Some conditions, such as diabetic ketoacidosis, exhibit visible symptoms only when an individual's condition already justifies an emergency examination by a physician. Other conditions, such as urinary tract infections, do not exhibit visible symptoms and can lead to kidney scarring, which may not manifest as a health problem for years.

[0004] Non-invasively measuring analyte concentrations in urine content is also ideally suited for epidemiological studies to quickly identify common problems in specific regions. However, difficulties in sample collection impede the acceleration of research in this field.

[0005] Absorbent articles such as diapers exist with embedded sensors that can only detect wetness. Often, they transmit that information to a receiving system. The receiving system then warns a caregiver of a one-time event. These wetness detection systems do not perform diagnoses.

[0006] Some existing diagnostic systems rely on urine test strips immersed in urine samples and are read manually or automatically by an imaging device or a mobile phone. Other diagnostic systems rely on urine test strips mounted on the outer surface of absorbent articles and, when wetted, are read manually or automatically by an imaging device or a mobile phone. In either case, data from current readings can be compared with those of both past and future readings.

[0007] In either approach, reading of the urine test strip is performed at a time point after the strip has been wetted with urine. Many of the chemicals used in the test strips are sensitive to exposure time, temperature, humidity, etc. Therefore, it is difficult to obtain accurate and reproducible readings.

[0008] In summary, analytes found in body fluids can be evidence of metabolic problems. There is a need to track and analyze changes in the concentration of analytes in body fluids such as urine over time. However, for the data to be useful, the readings must be accurate and reproducible. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0009] The present applicants have developed a novel and useful system for measuring analyte concentration in a body fluid. The system includes a durable component, an indicator component including an indicator zone having at least one colorimetric analyte sensing element, and at least one moisture sensor. The durable component has a housing having at least one window, 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 is arranged and configured to be attached to the durable component while the indicator zone is arranged adjacent to and in optical communication with at least one window and at least one spectrophotometer. The computing system is operably connected to the moisture sensor and at least one spectrophotometer. Additionally, the moisture sensor is arranged and configured to communicate the presence of moisture within 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.

[0010] The present applicants have also developed a novel and useful kit for measuring analyte concentration in body fluids. The kit includes a durability component, a plurality of indicator components having indicator zones, and at least one moisture sensor adjacent to the indicator zone. The coupler has a housing with at least one window, and at least one spectrophotometer adjacent to and optically communicating with the window, a computing system having at least one processor and a data storage device, and means for electronic communication between the computing system and at least one external device. Each indicator component is enclosed within an individual package and has a coupler for the durability component. Each indicator component is arranged and configured to be releasably attached to the durability component while the indicator zone is adjacent to and optically communicates with at least one window and at least one spectrophotometer. The computing system is operably connected to the moisture sensor and at least one spectrophotometer, and the moisture sensor is arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing element to the computing system. Each of the at least one colorimetric analyte sensing element is associated with a spectrophotometer.

[0011] The present applicants have also developed a novel and useful method for measuring analyte concentration in body fluids. The method includes collecting a body fluid and transporting it to at least one colorimetric analyte sensing element, and detecting the presence of the body 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 after a predetermined period after detecting the presence of the body fluid in contact with the colorimetric analyte sensing element, communicating the optical data to a computing system having at least one processor and a data storage device, and analyzing the optical data to determine the concentration of at least one analyte in the body fluid.

[0012] The present applicants have also developed a novel and useful method for measuring analyte concentration in a body fluid. The method includes obtaining a durability component, removing an indicator component from an individual package, where the indicator component comprises an indicator zone with at least one colorimetric analyte sensing element, and coupling the indicator component to the durability component. The durability component has a housing with at least one window, at least one spectrophotometer adjacent to and optically communicating with the window, a computing system having at least one processor and a 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 adjacent to and optically communicates with at least one window and at least one spectrophotometer, and the computing system is operably connected to the moisture sensor and at least one spectrophotometer. The moisture sensor is disposed adjacent to the indicator zone, and each of the at least one colorimetric analyte sensing element is associated with the spectrophotometer. The method also includes placing the assembly device in contact with a body fluid source, collecting the body fluid and transporting it to at least one colorimetric analyte sensing element, and detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element. The method further includes, after a predetermined period after detecting the presence of the body fluid in contact with the colorimetric analyte sensing element, collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer, communicating the optical data to a computing system having at least one processor and a data storage device, and analyzing the optical data to determine the concentration of at least one analyte in the body fluid.

[0013] The present applicants have also developed a novel and useful method for predicting the risk of future disease states. The method includes collecting a body fluid and transporting it to at least one colorimetric analyte sensing element; detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element; after detecting the presence of the body fluid, collecting optical data related to the at least one colorimetric analyte sensing element using at least one spectrophotometer after a predetermined period; communicating the optical data to a computing system having at least one processor and a data storage device; analyzing the optical data to determine the concentration of at least one analyte in the body fluid; identifying a threshold analyte concentration of at least one analyte in the body fluid that is an indicator of the risk of developing a future disease state; and recording the concentration of at least one analyte in the body fluid over time. BRIEF DESCRIPTION OF THE DRAWINGS

[0014]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

DETAILED DESCRIPTION OF THE INVENTION

[0015] The present invention relates to a system for use in an absorbent article for measuring changes in the concentration of an analyte in a body fluid such as urine over time, and a method for using this system to measure the concentration of an analyte in a body fluid over time, and a method for using these analyte measurements over time to detect an early-onset disease state in a human body.

[0016] The subject matter of the present disclosure is described more fully hereinafter with reference to the accompanying drawings and examples. However, the subject matter of the present disclosure can be embodied in different forms and should not be construed as limited to any of the specific embodiments described herein. Instead, the broadest scope consistent with the features described herein is provided. 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. Those skilled in the art will appreciate that they can make the most of the present invention based on the description herein.

[0017] 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.

[0018] The present invention relates to a system and method that enable monitoring of analyte concentration within an absorbent article. The system and method also enable statistical analysis and determination of changes in health status by collecting multiple data points over time, which may be evidence of a metabolic problem. Other data such as medical history and family history, and current variables such as age, temperature, and / or other current markers can be used to supplement the trends and statistical analysis.

[0019] Figures 1 - 6 show an apparatus or system 10 for measuring analyte concentration within an absorbent article. System 10 has an indicator component 20 and a durability component 100. Figure 1 is a top perspective view of system 10 when fully assembled, while Figure 2 is an exploded view of system 10.

[0020] The indicator component 20 is shown in exploded view in FIG. 2 and in cross-sectional view in FIG. 3. The indicator component 20 includes an indicator zone 21 having a colorimetric analyte sensing element 30 that can be disposed within an optional second flexible web 40, a fluid transport layer 50, an optional first flexible web 60, an optional upper plate 70, a coupler 80 shown here as a holding plate, and an adhesive layer 90. The indicator component 20 is preferably disposable.

[0021] The colorimetric analyte sensing element 30 has perforations 36 and is disposed within an opening 46 of the second flexible web 40. In some embodiments, the colorimetric analyte sensing element 30 is a reagent-impregnated matrix designed to produce a visual indicator of the presence of a preselected analyte in a sample generated by a wearer of the system 10. Chemical structures and methods for detecting analytes by producing a visual indicator are well known in the art. In some embodiments, the preselected analyte measured by the system 10 can be, among other things, glucose, ketone, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cell, and / or creatinine.

[0022] For example, the absorbent article can be a diaper, the fluid to be tested can be urine, and the preselected analyte measured by the system 10 can be glucose. Glycosuria, i.e., glucose in urine, is the presence of a higher than normal level of sugar in urine and can be due to complications related to an individual's kidneys or diabetes. Some of the most common causes of glucose in urine include true diabetes, hyperthyroidism, benign glycosuria, cirrhosis of the liver, or a high-carbohydrate diet. In addition, in some embodiments, one of ordinary skill in the art will recognize that it is possible to select an appropriate biosensor that can convert a preferred biomarker into a calorimetrically readable result and that can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers present in urine.

[0023] As described above, the colorimetric analyte sensing element 30 is disposed within the opening 46 of the second flexible web 40 and is in fluid communication with the fluid transport layer 50. The fluid transport layer 50 is, in turn, in fluid communication with the first flexible web 60. The second flexible web 40 has a first side 42 and is made of a non-absorbent material such as polyethylene foam. The fluid transport layer 50 has a first side 52 and perforations 56 and is made of a wicking material such as cloth or paper that is effective in diffusing and transporting fluid via capillary action. The first flexible web 60 has a first side 62 and perforations 66 and is made of a non-absorbent open film such as polyethylene mesh.

[0024] The second flexible web 40, the fluid transport layer 50, and the first flexible web 60 are designed to assist in the transport of fluid to the colorimetric analyte sensing element 30. In use, fluid from the absorbent article first contacts the first side 62 of the first flexible web 60. Since the first flexible web 60 is a non-absorbent open film, the fluid passes through the first flexible web 60 and contacts the first side 52 of the fluid transport layer 50. The fluid then permeates through the entire fluid transport layer 50. The fluid will contact the first side 42 of the second flexible web 40. However, since the second flexible web 40 is made of a non-absorbent material, the fluid within the transport layer 50 does not penetrate the second flexible web 40. Finally, the fluid within the transport layer 50 contacts the colorimetric analyte sensing element 30.

[0025] The sensing element 30, fluid transport layer 50, and first flexible web 60 disposed within the second flexible web 40 are stacked as shown in FIGS. 1-3 and held together by an upper plate 70 and a retaining plate 80. The retaining plate 80 has pins 88. The pins 88 sequentially pass through the perforations 36 of the colorimetric analyte sensing element 30, the perforations 56 of the fluid transport layer 50, and the perforations 66 of the first flexible web 60. Although not shown, the upper plate 70 has a blind hole in which the pins 88 are disposed. The friction fit between the blind hole of the upper plate 70 and the pins 88 holds the components of the indicator component 20 together. Alternative assemblies may be held together by other interactions such as snap fits, ultrasonic welding, thermal welding, other mechanical fasteners, and equivalents.

[0026] The upper 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. This provides a more controlled delivery of body fluid to the indicator zone and a related timing between the body fluid reaching the indicator zone and the colorimetric measurement, as described in more detail below.

[0027] The upper plate 70 may have channels on the side facing the first side 62 of the first flexible web 60. The channels may serve to direct fluid from the absorbent article to the first side 62 of the first flexible web 60.

[0028] The durability component 100 is shown in a disassembled top perspective view in FIG. 2, a top view in FIG. 4, a cross-sectional view in FIG. 5, and an enlarged cross-sectional view in FIG. 6. The durability component 100 has a housing 102 with a window 104. A spectrophotometer is disposed within the housing 102. The components of the spectrophotometer include a light source 122 and a photodetector 124. The spectrophotometer is adjacent to and in optical communication with the window 104. This enables the spectrophotometer to be in optical communication with the colorimetric analyte sensing element 30 of the indicator component 20.

[0029] As shown in FIG. 2, the spectrophotometer includes two light sources 122 and one photodetector 124. If desired, the spectrophotometer may include at least one or two or more light sources 122 and at least one photodetector 124, for example, at least two or three or more light sources 122 and at least two or three or more photodetectors 124.

[0030] FIG. 2 also shows a male connector protrusion 106 surrounding the window 104 on the housing 102. The male connector protrusion 106 enables the durability component 100 to be releasably attached to the indicator component 20.

[0031] FIG. 4 is a top view of the durability component 100 of the system 10. Conductive strips 108a and 108b are disposed on the upper surface of the male connector protrusion 106 and act as moisture sensors arranged and configured to communicate the presence of moisture within the colorimetric analyte sensing element 30 to a computer system disposed within the durability component 100 as described below.

[0032] FIGS. 4 and 5 also show two light sources 122 and photodetectors 124 that are linearly arranged and evenly spaced within the system 10. The equal spacing can also be achieved by other methods such as a plurality of two light sources 122 evenly arranged in a square or circular arrangement around the photodetector 124.

[0033] FIGS. 5 and 6 are cross-sectional views of the durability component 100. FIG. 5 shows the housing 102, the window 104, the male connector protrusion 106, the conductive strips 108a and 108b, and a printed circuit board (PCB) 120. FIG. 6 is an enlargement of the area of the durability component 100 that houses the components of the spectrophotometer.

[0034] The PCB 120 mechanically supports and electrically connects electronic components using conductive tracks, pads, and other features etched from copper sheets laminated on a non-conductive substrate. Components (e.g., capacitors, resistors, controllers, power supplies, light sources, detectors) are generally soldered onto the PCB 120. The PCB 120 has a computing system 140 having one or more processors and memory, and means 150 for electronic communication for transmitting the results of the analysis to a data processing system external to the system 10. Data processing systems that can be used include at least one external device including a server computer, a client computer, and a handheld device such as a mobile phone.

[0035] FIG. 5 shows the PCB 120 supported within the housing 102 of the durability component 100 using the support bracket 110. In other embodiments, the PCB 120 can be directly attached to the inner surface of the housing 102.

[0036] FIG. 6 is an enlargement of the area of the durability component 100 that houses the components of the spectrophotometer. The light source 122 and the photodetector 124, which are components of the spectrophotometer, are disposed on the surface of the PCB 120. They are shielded from ambient light by a shield 126 shown as a cylindrical ring whose two ends terminate on the surface of the PCB 120 and the inner surface of the housing 102 of the durability component 100. A skirt 128 is attached to the surface of the PCB 120 and serves to optically separate the light source 122 from the photodetector 124. Thus, during operation, the light emitted from the light source 122 cannot impinge on the photodetector 124 without reflecting from the colorimetric analyte sensing element 30.

[0037] Alternatively, a lens can be disposed covering the light source 122 so that the light emitted from the light source 122 during operation cannot impinge on the photodetector 124 without reflecting from the colorimetric analyte sensing element 30. Potting material can also be used to focus the light from the light source 122 onto the colorimetric analyte sensing element 30.

[0038] FIG. 6 also shows the optical chamber 130. The optical chamber 130 is a volume enclosed by the surface of the PCB 120, ambient light by the shield 126, the male connector projection 106, the conductive strip 108b, and the colorimetric analyte sensing element 30. The indicator zone 21 is the area of the indicator component 20 where the colorimetric analyte sensing element 30 is exposed to the light source 122.

[0039] Two light sources 122 are visible in FIGS. 5 and 6, but the durability component 100 may have a plurality of light sources 122, for example, four light sources evenly spaced around the device. The light source 122 can be a light-emitting diode (LED), which is a semiconductor light source that emits light when current flows through it. The LED has many advantages over incandescent light sources, including lower energy consumption, longer lifespan, improved physical robustness, smaller size, and faster switching. In the embodiments contemplated herein, the light source 122 is an RGB LED. Mixing red, green, and blue sources can produce white light with appropriate color mixing. Additionally, the colors emitted from the RGB LED can be monochromatic, which allows data to be acquired within a narrow wavelength range.

[0040] The photodetector 124 is also referred to as a photosensor. The photodetector is a sensor for light or other electromagnetic radiation. The photodetector has a p-n junction that converts light quanta into an electric current. The absorbed photons form electron-hole pairs in the depletion region. In some embodiments, the photodetector 124 can measure the amount of white light received. In the embodiments contemplated herein, the photodetector 124 specifically measures red, green, and blue light, allowing data to be acquired within a narrow wavelength range (note the "R", "G", and "B" above the photodetector 124 in FIG. 6).

[0041] In system 10 for measuring the concentration of an analyte within an absorbent article, light source 122 emits light at narrow red, green, and blue wavelengths. The emitted light waves are reflected from colorimetric analyte sensing element 30. The reflected light is then measured by photodetector 124. In this embodiment, light source 122 emits red light, green light, and blue light sequentially, enabling the nearly simultaneous collection of three data points. In other embodiments, the order of the emitted red light, green light, and blue light can vary.

[0042] The components of the spectrophotometer can be coated with a protective material. The protective material prevents moisture from contacting colorimetric analyte sensing element 30 and potentially damaging the components of the spectrophotometer.

[0043] Indicator component 20 is arranged and configured to be removably attached to durable component 100. When assembled, colorimetric analyte sensing element 30 is adjacent to and in optical communication with window 104 and the elements of the spectrophotometer.

[0044] Figures 4 - 6 also show conductive strips 108a and 108b disposed on the upper surface of male connector projection 106. Conductive strips 108a and 108b act as moisture sensors within system 10 and are arranged and configured to communicate the presence of moisture within colorimetric analyte sensing element 30 to a computing system disposed within durable component 100. Consequently, the computing system disposed within durable component 100 is operably connected to the moisture sensors and the components of the spectrophotometer.

[0045] As shown in Figure 6, conductive strips 108a and 108b are adjacent to colorimetric analyte sensing element 30. When moisture impinges on colorimetric analyte sensing element 30, it will also contact a portion of conductive strips 108a and 108b.

[0046] Figures 7 and 8 illustrate the function of conductive strips 108a and 108b within the moisture sensor in system 10. Figure 7 is a top view of conductive strips 108a and 108b at several points during the progression of the moisture front across the strips. The progression of the front is shown as A-A, B-B, C-C, and D-D. At point A-A, the moisture front is progressing across conductive strips 108a and 108b partially. Further progression across strips 108a and 108b is shown at points B-B and C-C, while D-D indicates the point at which the moisture front has completely crossed strips 108a and 108b.

[0047] Figure 8 shows an example of the change in electrical characteristics between strips 108a and 108b as the moisture front progresses across the strips. In this embodiment, Figure 8 shows a capacitance vs. time plot as the moisture front crosses strips 108a and 108b. Line A on Figure 8 corresponds to point A-A at which the moisture front has progressed across conductive strips 108a and 108b partially. The capacitance is shown to increase to line B, then to line C as points B-B and C-C indicate further progression across strips 108a and 108b. Finally, it is line D where the capacitance is shown at a level corresponding to point D-D at which the moisture front has completely crossed strips 108a and 108b. At point D-D, the colorimetric analyte sensing element 30 is completely saturated with moisture.

[0048] Although capacitance is being considered in this embodiment, other electrical characteristics such as resistance will also change as the moisture front progresses across strips 108a and 108b.

[0049] The moisture sensing system described above enables a spectrophotometer to perform a reading of the emitted light waves reflected from the colorimetric analyte sensing element 30 at a point in time after the strip has been wetted with moisture. This solves the problem that the chemicals used in the test strip are sensitive to time, temperature, and humidity, and enables accurate and reproducible readings to be obtained.

[0050] In a preferred embodiment, the plurality of light sources 122 are four narrow-beam LEDs spaced around the photodetector 124. Thus, the occurrence of wettability can be detected by a change in impedance by the conductive strips 108a and 108b. The accuracy of the start of sufficient saturation of the colorimetric analyte sensing element 30 can be improved by sequentially activating each of the narrow-beam LEDs and comparing the light detected by the photodetector 124. As a result of the different narrow-beam LEDs, if there is a significant difference between the data returned by the photodetector 124, the colorimetric analyte sensing element 30 may not be sufficiently saturated for a reliable analysis. Thus, in this embodiment, the system, after a predetermined period following bodily fluid contact with the colorimetric analyte sensing element 30, (1) changes in impedance by the conductive strips 108a and 108b, and (2) relatively consistent data returned by the photodetector 124 as a result of the different narrow-beam LEDs indicating substantially uniform wettability of the colorimetric analyte sensing element 30, may begin to collect optical data regarding the colorimetric analyte sensing element 30.

[0051] The embodiments described above are embodiments of the system 10 for measuring analyte concentration within an absorbent article having the indicator component 20 and the durability component 100, although in some cases it is envisioned that the durability component 100 may be combined with a plurality of indicator components 20 to create a kit for measuring analyte concentration within an absorbent article. The kit has at least one, preferably one or more individually packaged indicator components 20. This allows the kit to measure the analyte concentration within the absorbent article daily, or weekly, or monthly, or once or more than once a day, or once a week, or once a month. When used in this way, the system 10 is used to track changes in the analyte concentration measured over several days, weeks, months, or even years.

[0052] Disposable absorbent articles for use with a system 10 for measuring analyte concentration include absorbent hygiene articles such as diapers (including infant diapers, training pants, and adult incontinence products) and pads (including feminine sanitary napkins and pantiliners, as well as nursing pads).

[0053] For example, the absorbent article for use with the system 10 for measuring analyte concentration is a diaper, and the analyte concentration is measured in urine. The indicator component 20 has attachment means such as an adhesive layer 90. The adhesive layer 90 is used to attach or bond the indicator component 20 of the system 10 to the fluid transport layer of the diaper. The system 10 can be attached to the body-facing surface of the diaper. Other attachment means will readily become apparent, including but not limited to mechanical fasteners such as clips, clamps, hook and loop systems, and bands, magnetism (including static electricity), friction, and the like. The indicator component can be arranged and configured to be removably attached to the diaper.

[0054] A system for measuring analyte concentration within an absorbent article can have a plurality of colorimetric analyte sensing elements. FIGS. 9-17 show a system for measuring analyte concentration within an absorbent article of the present invention. The system 200 has an indicator component 220 and a durability component 300. FIGS. 9 and 10 are, respectively, the top and bottom of the system 200 when fully assembled.

[0055] The indicator component 220 is shown in exploded view in FIG. 11. The indicator component 220 includes an indicator zone 221 having a pair of colorimetric analyte sensing elements, namely, a first colorimetric analyte sensing element 230a and a second colorimetric analyte sensing element 230b. The first colorimetric analyte sensing element 230a has a first side 232a, a second side 234a, and a perforation 236a. The second colorimetric analyte sensing element 230b has a first side 232b, a second side 234b, and a perforation 236b.

[0056] The colorimetric analyte sensing elements 230a, 230b can be reagent-impregnated matrices designed to generate a visual indicator of the presence of a preselected analyte in a sample generated by a wearer of the system 200. Chemical structures and methods for detecting analytes by generating visual indicators are well known in the art. The preselected analytes measured by the system 200 can be, inter alia, glucose, ketones, bilirubin, blood, pH, proteins, urobilinogen, nitrites, white blood cells, and / or creatinine.

[0057] The colorimetric analyte sensing elements 230a, 230b can be designed to generate a visual indicator of the presence of the same preselected analyte in a sample generated by a wearer of the system 200. In this case, the colorimetric analyte sensing elements 230a, 230b act to confirm the analysis. The colorimetric analyte sensing elements 230a, 230b can also be designed to generate a visual indicator of the presence of different preselected analytes in a sample generated by a wearer of the system 200.

[0058] Again, the absorbent article can be a diaper, the fluid to be examined can be urine, and the preselected analyte measured by the system 200 can be glucose. Glycosuria, i.e., glucose in urine, is the presence of higher than normal levels of sugar in urine and can be due to complications related to an individual's kidneys or diabetes.

[0059] The preselected analyte measured by the system 200 can also be ketones. When the cells in the body do not get enough glucose, the body burns fat for energy instead. This produces ketones that can appear in the blood and urine. High ketone levels in urine can indicate diabetic ketoacidosis (DKA), a complication that can even lead to coma or death.

[0060] Some of the most common causes of glucose in urine include diabetes mellitus, hyperthyroidism, benign glycosuria, cirrhosis of the liver, or a high-carbohydrate diet. Additionally, in some embodiments, one of ordinary skill in the art will recognize that appropriate biosensors 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.

[0061] Other components of the indicator component 220 include an optional upper plate 270, an optional first flexible web 260, a fluid transport layer 250, a second flexible web 240, an adhesive layer 290, and a coupler 280 shown here as a retaining plate.

[0062] The colorimetric analyte sensing elements 230a, 230b are encapsulated between a first encapsulation layer 410 and a second encapsulation layer 430 to form a fluid-impermeable envelope 431. The first encapsulation layer 410 has a first side 412 and a second side 414, as well as perforations 416 and openings 418. The second encapsulation layer 430 has a first side 432 and a second side 434, as well as perforations 436 and openings 438.

[0063] FIG. 12 is a top perspective view of a fluid-impermeable envelope 431 encapsulating the colorimetric analyte sensing elements 230a, 230b of the indicator component 220 of system 200. FIG. 13 shows a top view of the fluid-impermeable envelope 431 encapsulating the colorimetric analyte sensing elements of FIG. 12. The figure shows, in solid lines, the first side 432, the perforation 436, and the opening 438 of the second encapsulation layer 430. In dashed lines, the figure shows the colorimetric analyte sensing elements 230a, 230b, their first sides 232a, 232b, and perforations 236a, 236b, and the opening 418 of the first encapsulation layer 410. The dashed lines showing the colorimetric analyte sensing elements 230a, 230b also depict the contour of an individual pocket 433 (one of two shown in FIG. 13) formed when the first encapsulation layer 410 and the second encapsulation layer 430 are both sealed where their surfaces contact.

[0064] When assembled, the first perforation 436 of the second encapsulation layer 430 is aligned with the perforations 236a, 236b of the colorimetric analyte sensing elements 230a, 230b and the perforation 416 of the first encapsulation layer 410 (not shown). Additionally, the opening 438 of the second encapsulation layer 430 is aligned with the opening 418 of the first encapsulation layer 410.

[0065] The fluid-impermeable envelope 431 encapsulating the colorimetric analyte sensing elements 230a, 230b of the indicator component 220 of system 200 is disposed on the fluid transport layer 250. This partially assembled indicator component of system 200 is shown in a top view in FIG. 14 and a bottom view in FIG. 15. FIG. 14 shows, in solid lines, the first side 252, the first perforation 256, and the second perforation 258 of the fluid transport layer 250. In dashed lines, the figure shows the colorimetric analyte sensing elements 230a, 230b, their first sides 232a, 232b, and perforations 236a, 236b, and the opening 418 of the first encapsulation layer 410 and the first side 432 and opening 438 of the second encapsulation layer 430.

[0066] FIG. 15 shows, in solid lines, the second side 252 of the fluid transport layer 250, and the second side 414, the perforations 416, and the openings 418 of the first encapsulation layer 410. In dashed lines, the figure shows the colorimetric analyte sensing elements 230a, 230b, their second sides 234a, 234b, and the perforations 236a, 236b, and the second perforation 258 of the fluid transport layer 250.

[0067] The second flexible web 240 has a first side 242, a second side 244, and an opening 246, and is made of a non-absorbent material such as polyethylene foam. The fluid-impermeable envelope 431 that encapsulates the colorimetric analyte sensing elements 230a, 230b is specifically disposed on the second flexible web 240 within the opening 246 of the second flexible web 240 and is in fluid communication with the fluid transport layer 250. The fluid transport layer 250 is in turn in fluid communication with the first flexible web 260. The first flexible web 260 has a first side 262 and a perforation 266, and is made of a non-absorbent open film such as polyethylene mesh.

[0068] The second flexible web 240, the fluid transport layer 250, and the first flexible web 260 are designed to control the transport of body fluid to the colorimetric analyte sensing elements 230a, 230b and to limit cross-contamination of fluids between different colorimetric analyte sensing elements. In use, fluid from the absorbent article first contacts the first side 262 of the first flexible web 260. Since the first flexible web 260 is a non-absorbent apertured film, the fluid passes through the first flexible web 260 and contacts the first side 252 of the fluid transport layer 250. The fluid then permeates through the entire fluid transport layer 250. The fluid will contact the first side 242 of the second flexible web 240. However, since the second flexible web 240 is made of a non-absorbent material, the fluid in the transport layer 250 does not penetrate the second flexible web 240. Finally, the fluid in the transport layer 250 passes through the openings 438 of the second encapsulation layer 430 and contacts the colorimetric analyte sensing elements 230a, 230b. Cross-contamination between the two colorimetric analyte sensing elements is eliminated or made at least insignificant and undetectable using a fluid barrier defined by a gap in the capillary action within the fluid transport layer 250 provided by the second perforations 258.

[0069] The sensing elements 230a, 230b, the first encapsulation layer 410, the second encapsulation layer 430, the second flexible web 240, the fluid transport layer 250, and the first flexible web 260 are stacked as shown in FIG. 11 and held together by the upper plate 270 and the retaining plate 280. The upper plate 270 has pins 278. The pins 278 sequentially pass through the perforations 266 of the first flexible web 260, the perforations 256 of the fluid transport layer 250, the perforations 416 of the first encapsulation layer 410, the perforations 236a, 236b of the colorimetric analyte sensing elements 230a, 230b, the first perforation 436 of the second encapsulation layer 430, and the opening 246 of the second flexible web 240, and finally are disposed within the blind hole 286 of the retaining plate 280. The friction fit between the upper plate pins 278 and the blind holes 286 holds the components of the indicator component 220 together. Alternative assemblies may be held together by other interactions such as snap fits, ultrasonic welding, thermal welding, other mechanical fasteners, and equivalents.

[0070] The upper plate 270 may have one or more channels on the side facing the first side 262 of the first flexible web 260. The channels may serve to direct fluid from the absorbent article to the first side 262 of the first flexible web 260.

[0071] The indicator component 220 may have attachment means such as an adhesive layer 290. The adhesive layer 290 has a first side 292 and is used to attach or bond the indicator component 220 of the system 200 to the fluid transport layer of an absorbent article such as a diaper.

[0072] The durability component 300 of the system is shown in a top perspective view in FIG. 16 and in a top view in FIG. 17. The durability component 300 has a housing 302 having a pair of windows, namely, a first window 304a and a second window 304b. The durability component 300 also has a flat top surface 306. A pair of spectrophotometers are disposed within the housing 302. The first spectrophotometer is adjacent to and in optical communication with the first window 304a. The components of the first spectrophotometer include a light source 322a and a photodetector 324a. The first spectrophotometer is in optical communication with the colorimetric analyte sensing element 230a. The second spectrophotometer is adjacent to and in optical communication with the second window 304b. The components of the second spectrophotometer include a light source 322b and a photodetector 324b. The second spectrophotometer is in optical communication with the colorimetric analyte sensing element 230b. The durability component 300 is shown with two spectrophotometers, although additional spectrophotometers may be included for the measurement of additional analytes such as pH, temperature, or bodily fluid states. The indicator-zone 221 is the area of the indicator component 220 where the colorimetric analyte sensing element 230a is exposed to the light source 322a.

[0073] Although not shown, the durability component 300 also involves a printed circuit board (PCB) with a computing system having one or more processors and memory, and also has means for electronic communication for transmitting the results of the analysis to a data processing system external to the system 200. 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 FIGS. 16 and 17, the first and second spectrometers may include four light sources 322a, 322b, and each spectrometer has one photodetector 324a, 324b. Each spectrometer may have at least one light source 322a, 322b associated therewith. Each spectrometer may include at least six or more than seven light sources 322a, 322b. As described above, the light sources 322a, 322b may be light emitting diodes (LEDs), more specifically, RGB LEDs. The light sources 322a, 322b may sequentially emit red light, green light, and blue light, enabling the substantially simultaneous collection of three data points, or the order of the emitted red light, green light, and blue light may vary.

[0075] The photodetectors 324a, 324b within the spectrometer may specifically measure red, green, and blue light, as previously discussed, enabling data to be acquired within a narrow wavelength region. The light waves emitted from the light source 322a are reflected from the colorimetric analyte sensing element 230a, and the reflected light is measured by the photodetector 324a. The light waves emitted from the light source 322b are reflected from the colorimetric analyte sensing element 230b, and the reflected light is measured by the photodetector 324b. The components of the spectrometer may be coated with a protective material. The protective material prevents moisture from contacting the colorimetric analyte sensing elements 230a, 230b and potentially damaging the components of the spectrometer.

[0076] Figures 16 and 17 also show a connector 310 disposed on the housing 302. The connector 310 includes a standard spring load clip 312 that is biased to hold the clip 312 to the housing 302 of the durability component 300. As shown in FIG. 11, the retaining plate 280 has a receiving element 286 disposed thereon. The clip 312 is fastened to the receiving element 286 to removably attach the durability component 300 to the retaining plate 280. By this means, the durability component 300 is removably attached to the indicator component 220. Other attachment means will readily become apparent, including but not limited to mechanical fasteners such as clips, clamps, hook and loop systems, threaded openings, bayonet couplings, straps, belts, and bands, magnetic (including electrostatic), friction, and the like.

[0077] FIG. 17 also shows conductive strips 308a, 308b, 308c, and 308d disposed on the upper surface 306 of the durability component 300. The conductive strips 308a, 308b, 308c, and 308d act as moisture sensors arranged and configured to communicate the presence of moisture in the colorimetric analyte sensing elements 230a, 230b to a computing system disposed within the durability component 300. As shown in FIG. 17, the conductive strips 308a and 308b are associated with the first window 304a and the colorimetric analyte sensing element 230a. The conductive strips 3_{08}c and 308d are associated with the second window 304b and the colorimetric analyte sensing element 230b. The computing system disposed within the durability component 300 is operably connected to the moisture sensor as well as components of the spectrophotometer.

[0078] Conductive strips 308a and 308b are adjacent to the colorimetric analyte sensing element 230a. When moisture impinges on the colorimetric analyte sensing element 230a, it will also contact a portion of the conductive strips 308a and 308b. Conductive strips 308c and 308d are adjacent to the colorimetric analyte sensing element 230b. When moisture impinges on the colorimetric analyte sensing element 230b, it will also contact a portion of the conductive strips 308c and 308d.

[0079] The operating modes of the conductive strips 308a, 308b, 308c, and 308d as moisture sensors are the same as the operation of the conductive strips 108a and 108b as described in FIGS. 7 and 8. The moisture front progresses partially and ultimately completely across the conductive strips 308a and 308b, and 308c and 308d. A system for measuring analyte concentration in a body fluid can be used in an absorbent article or can be directly contacted by body fluid outside the absorbent article. For example, the system can contact body fluid collected within a specimen container or can contact body fluid such as urine as the fluid is excreted from the human body. FIGS. 18 - 20 illustrate a system for measuring analyte concentration in a body fluid of the present invention. System 500 has an indicator component 520 and a durability component 600. FIG. 18 is a top perspective view of the system 500 when fully assembled. FIG. 19 is a top perspective view of the indicator component 520 of the system 500. FIG. 20 is a partially exploded view of the system 500 in which the indicator component 520 is shown in an exploded view.

[0080] In FIG. 20, the indicator component 520 includes an indicator zone 521 shown to have a pair of colorimetric analyte sensing elements, namely a first colorimetric analyte sensing element 530a and a second colorimetric analyte sensing element 530b. The first colorimetric analyte sensing element 530a has a first side surface 532a and a perforation 536a. The second colorimetric analyte sensing element 530b has a first side surface 532b and a perforation 536b.

[0081] As previously discussed, the colorimetric analyte sensing elements 530a, 530b can be reagent-impregnated matrices designed to produce a visual indicator 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 can be, inter alia, glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cells, and / or creatinine.

[0082] Again, the colorimetric analyte sensing elements 530a, 530b can be designed to indicate the presence of the same preselected analyte in a sample 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 can also be designed to produce a visual indicator of the presence of different preselected analytes in a sample generated by a user of the system 500.

[0083] Again, the fluid to be tested can be urine, and the preselected analytes measured by the system 500 can be glucose, one or more ketones, or a combination thereof. The presence of levels of glucose and / or ketones in urine that are higher than normal can be due to complications related to the user's kidneys, or other conditions such as diabetes mellitus, hyperthyroidism, benign diabetes, cirrhosis of the liver, or a high-carbohydrate diet.

[0084] In addition, 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 body fluids.

[0085] Other components of the indicator component 520 include an upper plate 570, a first flexible web 560, a fluid transport layer 550, a first encapsulation layer 710, a second encapsulation layer 730, and a coupler 580 shown here as a holding plate.

[0086] 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 surface 712, perforations 716, and an opening 718. The second encapsulation layer 730 has a first side surface 732, perforations 736, and an opening 738.

[0087] When assembled to the indicator component 520, the perforations 716 of the first encapsulation layer 710 are aligned with the perforations 536a, 536b of the colorimetric analyte sensing elements 530a, 530b and the perforations 736 of the second encapsulation layer 730. Additionally, the opening 718 of the first encapsulation layer 710 is aligned with the opening 738 of the second encapsulation layer 730.

[0088] FIG. 20 also shows a fluid transport layer 550 and a first flexible web 560. When assembled to the indicator component 520, the fluid transport layer 550 is disposed over the encapsulated colorimetric analyte sensing elements 530a, 530b of the indicator component 520 of the system 500. The fluid transport layer 550 has a first side surface 552, a first perforation 556, and a second perforation 558. The first flexible web 560 is disposed over the fluid transport layer 550, has a first side surface 562 and a perforation 566, and is made of a non-absorbent open film such as a polyethylene mesh.

[0089] When assembled to the indicator component 520, the colorimetric analyte sensing elements 230a, 230b encapsulated in the fluid-impermeable envelope 731 are in fluid communication with the fluid transport layer 550. The fluid transport layer 550 is, in turn, in fluid communication with the first flexible web 560.

[0090] The fluid transport layer 550 and the first flexible web 560 are designed to control the transport of body fluid to the colorimetric analyte sensing elements 530a, 530b and to limit cross-contamination of fluids between different colorimetric analyte sensing elements. In use, the body fluid first contacts the first side 562 of the first flexible web 560. Since the first flexible web 560 is a non-absorbent apertured film, the fluid passes through the first flexible web 560 and contacts the first side 552 of the fluid transport layer 550. The fluid then permeates through the entire fluid transport layer 550. Finally, the fluid in the transport layer 550 passes through the openings 738 of the second encapsulation layer 730 and contacts the colorimetric analyte sensing elements 530a, 530b. Again, cross-contamination between the two colorimetric analyte sensing elements is eliminated or made at least insignificant and undetectable using a fluid barrier defined by the gaps in the capillary action within the fluid transport layer 550 provided by the second perforation 558.

[0091] The sensing elements 530a, 530b, the first encapsulation layer 710, the second encapsulation layer 730, the fluid transport layer 550, and the first flexible web 560 are stacked as shown in FIG. 20 and held together by the upper plate 570 and the retaining plate 580. The upper plate 570 has pins 578. The pins 578 sequentially pass through the perforations 566 of the first flexible web 560, the perforations 556 of the fluid transport layer 550, the perforations 716 of the first encapsulation layer 710, the perforations 536a, 536b of the colorimetric analyte sensing elements 530a, 530b, and the perforations 736 of the second encapsulation layer 730, and are finally disposed within the blind holes 586 on the first side 582 of the retaining plate 580. The friction fit between the upper plate pins 578 and the blind holes 586 holds the components of the indicator component 520 together. Alternative assemblies can be held together by other interactions such as snap fits, ultrasonic welding, thermal welding, other mechanical fasteners, and equivalents.

[0092] The upper plate 570 has an opening 576 that serves to direct fluid toward the first side 562 of the first flexible web 560. The upper plate 570 also has a protrusion 575 disposed thereon. The protrusion 575, as well as the protrusion 587 disposed on the holding plate 580, are means for attaching the indicator component 520 to the durability component 600 of the system 500.

[0093] The durability component 600 is shown in a top perspective view in FIG. 20. The durability component 600 having a proximal end 620 and a distal end 630 has a housing 602 having a pair of windows, namely a first window 604a and a second window 604b. The durability component 600 also has a flat top surface 606, conductive rings 608a and 604b, a receiving element 605, protrusions 610, an activation button 650, and a finger grip 660.

[0094] 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. The durability component 600 is shown with two spectrophotometers, although additional spectrophotometers may be included for the measurement of additional analytes such as pH, temperature, or bodily fluid conditions. The indicator-zone 521 is the area of the indicator component 520 where the colorimetric analyte sensing element 530a is exposed to the light source.

[0095] Although not shown, the durability component 600 also has a printed circuit board (PCB) with a computing system having one or more processors and memory, as well as means for electronic communication for transmitting the results of the analysis to a data processing system external to the system 500. The data processing system that may be used includes at least one external device including a server computer, a client computer, and a handheld device such as a mobile phone.

[0096] As considered in other embodiments of this document, the spectrophotometer may include at least one, or two or more, or two or three or more, or four or five or more, or six or seven or more light sources and at least one, or at least two or three or more photodetectors. Also, as described above, the light source within the durability component 600 may be a light-emitting diode (LED), more specifically, an RGB LED. The light source may sequentially emit red light, green light, and blue light, enabling the nearly simultaneous collection of three data points, or the order of the emitted red light, green light, and blue light may vary.

[0097] The photodetectors within the durability component 600 may also specifically measure red, green, and blue light, as previously considered, enabling data to be acquired within a narrow wavelength region and may be coated with a protective material to reduce the possibility of damage to those components.

[0098] FIG. 18 shows a top perspective view of the durability component 600 and the indicator component 520 assembled to form the system 500. Here, the indicator component 520 is disposed on the distal end 630 of the durability component 600. The upper plate 570 of the durability component 600 has a protrusion 575, and the retaining plate 580 has a protrusion 587. The durability component 600 has a receiving element 605 and a protrusion 610. To releasably attach the indicator component 520 to the durability component 500, the protrusion 575 of the upper plate 570 is disposed within the receiving element 605 of the durability component 600. Then, the protrusion 587 of the retaining plate 580 is engaged with the protrusion 610 of the durability component 600 using a snap connection.

[0099] Figure 20 shows conductive strips 608a and 608b disposed on the upper surface 606 of the durability component 600. Conductive strips 608a and 608b act as moisture sensors for 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 durability component 600. In this embodiment, conductive strip 608a is associated with the first window 604a and the colorimetric analyte sensing element 530a. Conductive strip 308b is associated with the second window 604b and the colorimetric analyte sensing element 530b. The computing system disposed within the durability component 600 is operably connected to the moisture sensors as well as the components of the spectrophotometer.

[0100] The mode of operation of conductive strips 608a and 608b as moisture sensors is identical to the operation of conductive strips 108a and 108b as described in FIGS. 7 and 8. The moisture front progresses partially and ultimately completely across conductive strips 608a and 608b.

[0101] The durability component may correspond to a plurality of indicator components to create a kit for measuring analyte concentration in an absorbent article. For example, the kit may have durability components 100, 300, 600 (described above), and a plurality of indicator components 20, 220, 520 (described above). To ensure the integrity of the indicator components during storage, each such indicator component is enclosed within an individual package.

[0102] The present invention also includes a method for measuring the concentration of an analyte in an absorbent article. Body fluid is collected and transported through a transport layer to at least one colorimetric analyte sensing element. The presence of body fluid within the at least one colorimetric analyte sensing element initiates a countdown over a predetermined period. Optical data associated with the colorimetric analyte sensing element is collected by at least one spectrophotometer after the predetermined period. The optical data is communicated to a computing system having at least one processor and a data storage device. The optical data is analyzed to determine the concentration of at least one analyte in the body fluid.

[0103] The predetermined period following contact of the body fluid 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 more. The predetermined period following contact of the body fluid with the colorimetric analyte sensing element can be, for example, within a predetermined time range of about 15 to about 360 seconds, or about 30 to about 240 seconds, or about 120 to about 180 seconds, or about 240 to about 360 seconds.

[0104] The analyte measured by the system can be, inter alia, glucose, ketone, bilirubin, blood, pH, protein, urobilinogen, nitrite, white blood cell, and / or creatinine.

[0105] Analytes found in body fluid potentially carry evidence of potential metabolic problems. There is a desire for people within and outside of medical facilities to track and analyze changes in the concentration of analytes in body fluid over time. These changes can be useful for predicting the risk of future disease states. Thus, the system contemplated by the present invention enables a method for predicting the risk of future disease states.

[0106] As described above, body fluid is collected and transported via a transport layer to at least one colorimetric analyte sensing element. The presence of body fluid in at least one colorimetric analyte sensing element starts a countdown over a predetermined period. Optical data related to the colorimetric analyte sensing element is collected by at least one spectrophotometer after the predetermined period. The optical data is communicated to a computing system having at least one processor and a data storage device. The optical data is analyzed to determine at least one analyte concentration in the body fluid. At least one threshold analyte concentration indicative of the 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.

[0107] The system can be arranged, configured, and programmed with a plurality of photodetectors 124 and a plurality of colorimetric analyte sensing elements 30 to determine a plurality of analyte concentrations in body fluid.

[0108] Non-invasively measuring analyte concentrations in body fluid is also ideally suited for epidemiological studies to quickly identify common problems in a particular region or for a particular population of people. Analyte concentration measurements from system 10 can be collected over a long period across a wide population. The data collected is studied to determine the relationship between various analyte levels and disease states or combined with other physiological parameters such as blood pressure, blood oxygen level, and pulse rate, or demographic statistics such as age, gender, weight, and nationality to create a predictive model of future disease states as a function of stored parameters.

[0109] The foregoing 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 body fluids without using an absorbent article. For example, system 500 may be attached to the body-facing surface of a diaper. The systems 500 of FIGS. 18-20 may be placed in direct contact with body fluids. It may be immersed in the body fluid initially collected in a specimen container by gripping system 500 by finger grip 660 on proximal end 620 of durable component 600. System 500 may be powered by user-engaged activation button 650 on proximal end 620 of durable component 600 either before or after inserting distal end 630 into the specimen container. Alternatively, the indicator component of system 500 may be placed into the flow of body fluid such as urine as the fluid is excreted from the human body. In these uses, durable component 600 is a hand-held analyzer.

Example

[0110] Example 1: Demonstration of the stability of reflectance values versus time in a colorimetric analyte sensing element. To test the change in reflectance values versus time, measurements of the reflectance values were performed using a prototype spectrophotometer on a series of prototype colorimetric analyte sensing elements exposed to a glucose solution at room temperature.

[0111] The prototype spectrophotometer was constructed using the following components. · Light source 122: An RGB LED having light wavelengths of 624, 525, and 468 nm from INOLUX (Santa Clara, CA). The part number is IN-S66TATRGB. · Photodetector 124: An integrated circuit (IC) color light digital converter having an infrared (IR) filter. The integrated circuit provides digital values for red, green, blue (RGB), and clear light sensing. The IR blocking filter minimizes the IR light spectral component and enables accurate color measurements. The part number was TCS34725 available from ams AG (Premstaetten, Austria).

[0112] The prototype colorimetric analyte sensing element 30 was a porous polysulfone membrane from PortaScience Inc. (Moorsetown, NJ). The following mixture was injected into the membrane. · Glucose oxidase: 16.3% W / W · Horseradish peroxidase: 0.6% W / W · Potassium iodide: 7% W / W · 60.7% W / W buffer, and · 16.7% W / W non-reactive component.

[0113] The tests were performed using an artificial urine solution with a glucose concentration of 25 milligrams / deciliter. All tests were performed at room temperature.

[0114] Light scans at three wavelengths (red, green, blue) were performed on the dry colorimetric analyte sensing element so that the baseline color of the element was established. The colorimetric analyte sensing element was then saturated with the artificial urine solution. Reflectance measurements were performed in the three channels of light (red, green, and blue) every 30 seconds, and the reflectance was recorded.

[0115] Table 1.1 shows the reflectance from the saturated colorimetric analyte sensing element at each wavelength at each time point.

[0116]

Table 1

[0117] The table shows that the reflectance of light decreased at each of the wavelengths tested as time increased.

[0118] Next, the relative variation of the trace was calculated using the following formula. Relative variation (t2) = 100 * [Reflectance (t1) - Reflectance (t2)] / Reflectance (t0) Where Reflectance (t1) and Reflectance (t2) are the reflectance measurement values at time 1 and time 2, respectively, The reflectance (t0) is the reflectance measurement of the dried colorimetric analyte sensing element.

[0119] The unit of relative variation is percent (%).

[0120] For example, using the reflectance measurements of the green channel from Table 1.1, the relative variation at 60 seconds was calculated as follows. Relative variation (t 60 ) = 100 * [1885 - 1736] / 2422 = 6.15%

[0121] Table 1.2 shows the relative variation of the reflectance measurements of the green channel from the colorimetric analyte sensing element at each time point.

[0122]

Table 2

[0123] The table shows the last three values of the converging relative variation. Thus, in this example, the data obtained 150 seconds after the colorimetric analyte sensing element is saturated with the glucose solution can be used by the algorithm to evaluate the glucose concentration. Alternatively, the algorithm can use the data obtained 120 - 180 seconds after the colorimetric analyte sensing element is saturated with the glucose solution when testing for glucose.

[0124] In other embodiments, the converged value of the relative variation can be used to determine the appropriate time to record the data. Thus, for example, if the relative variation falls below 2 percent, or 1.5 percent, the algorithm can select that time point as the time to record the data.

[0125] Of course, the limitations of this test when compared to realistic conditions include the temperature of the solution and the rate at which actual urine would saturate the colorimetric analyte sensing element within the system. However, this qualitative example can reflect the actual process. Extensive testing under realistic conditions must be continued.

[0126] Example 2: Demonstration of the stability of reflectance values over time in a colorimetric analyte sensing element having a moisture sensor. As described above, the conductive strips 108a and 108b act as moisture sensors within the system 10 and are arranged and configured to communicate the presence of moisture within the colorimetric analyte sensing element 30 to a computing system disposed within the durability component 100. In this example, measurements of the reflectance values were performed using a prototype spectrophotometer on a series of prototype colorimetric analyte sensing elements exposed to a glucose solution at room temperature, and the moisture sensor was used to initiate the inspection of the analyte in the colorimetric sensor.

[0127] The prototype spectrophotometer and the prototype colorimetric analyte sensing elements were the same as those used in Example 1, which was an artificial urine solution (glucose concentration of 25 milligrams per deciliter). As in Example 1, all tests were performed at room temperature.

[0128] The tests were performed as follows. 1. 1.5 mL of artificial urine was applied to the periphery of the prototype colorimetric analyte sensing element at the 3 o'clock position. 2. The capacitor moisture sensor indicated complete wetting of the sensor in less than 20 seconds. 3. The prototype colorimetric analyte sensing element was placed face up on the prototype spectrophotometer, and reflectance measurements were performed at 60 - second intervals in three channels of light (red, green, and blue). The reflectance was recorded.

[0129] Table 2.1 shows the reflectance from the saturated colorimetric analyte sensing element at each wavelength at each time point.

[0130]

Table 3

[0131] The relative variation of the reflectance measurements in the green channel was calculated as shown in Example 1. Table 2.2 shows the relative variation of the reflectance measurements at each time point.

[0132]

Table 4

[0133] The table shows that the last three values of the relative variation indicate the conversion of the data. Thus, in this example, data obtained 240 or 300 seconds after the colorimetric analyte sensing element is saturated with the glucose solution may be good for use in an algorithm to evaluate the glucose concentration. Alternatively, the algorithm may use data obtained 240 - 360 seconds after the colorimetric analyte sensing element is saturated with the glucose solution when testing for glucose.

[0134] The foregoing specification, embodiments, and examples are presented to assist 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 is defined by the claims appended hereto.

[0135] 〔Embodiment〕 (1) A system for measuring the concentration of an analyte in a body fluid, comprising: a) A durable component comprising a housing, the housing having at least one window, and i) At least one spectrophotometer adjacent to and in optical communication with the window, and ii) A computing system having at least one processor and a data storage device, and iii) Means for electronic communication between the computing system and at least one external device, the durable component containing the same; b) An indicator component comprising an indicator zone having at least one colorimetric analyte sensing element; c) At least one moisture sensor adjacent to the indicator zone. Comprising I) The indicator component is arranged and configured to be attached to the durability component while the indicator zone is 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) A system wherein each of the at least one colorimetric analyte sensing element is associated with a spectrophotometer. (2) The system according to embodiment 1, wherein the indicator component further comprises a fluid transport layer in fluid communication with the indicator zone. (3) The system according to embodiment 2, wherein the indicator component further comprises a fluid-impermeable envelope surrounding the indicator zone, the fluid-impermeable envelope having individual pockets arranged and configured to contain each of the at least one colorimetric analyte sensing element, each pocket having a unique opening in fluid communication with the fluid transport layer. (4) The system according to embodiment 3, wherein the indicator zone comprises at least two colorimetric analyte sensing elements, each of the at least two colorimetric sensing elements being separated from the other colorimetric sensing elements. (5) The system according to embodiment 4, wherein the at least one moisture sensor includes a plurality of moisture sensors, each moisture sensor being arranged and configured to communicate the presence of moisture in each of the at least two colorimetric analyte sensing elements to the computing system.

[0136] (6) The indicator component comprises: i) an upper plate; ii) a first flexible web layer; iii) a fluid transport layer adjacent to the first flexible web layer; (iv) A fluid-impermeable envelope surrounding the indicator zone adjacent to the fluid transport layer; (v) A second flexible web layer adjacent to the fluid-impermeable envelope; (vi) Attachment means disposed on the second flexible web layer; (vii) A holding plate; and further comprising; (V) The first flexible web layer, the fluid transport layer, the fluid-impermeable envelope, and the second flexible web layer are stacked in sequence and fixed between the upper plate and the holding plate; (VI) The indicator zone comprises at least two colorimetric analyte sensing elements; (VII) The fluid-impermeable envelope has individual pockets arranged and configured to contain each of the at least two colorimetric analyte sensing elements, each pocket having a unique opening in fluid communication with the fluid transport layer; (VIII) The fluid transport layer is arranged and configured to prevent fluid transport between the openings within the fluid-impermeable envelope. The system according to Embodiment 1. (7) The upper plate and the holding 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. The system according to Embodiment 6. (8) The indicator component comprises; (i) A first flexible web layer; (ii) A fluid transport layer adjacent to the first flexible web layer; (iii) A fluid-impermeable envelope surrounding the indicator zone adjacent to the fluid transport layer; and further comprising; (V) The first flexible web layer, the fluid transport layer, and the fluid-impermeable envelope are stacked in sequence and fixed together; (VI) The indicator zone comprises at least two colorimetric analyte sensing elements; (VII) The fluid-impermeable envelope has individual pockets arranged and configured to contain each of the at least two colorimetric analyte sensing elements, and each pocket has a unique opening in fluid communication with the fluid transport layer. (VIII) The system of embodiment 1, wherein the fluid transport layer is arranged and configured to prevent fluid transport between openings within the fluid-impermeable envelope. (9) iv) an upper plate adjacent to the first flexible web layer; v) a holding plate; further comprising: The system of embodiment 8, wherein the first flexible web layer, the fluid transport layer, and the fluid-impermeable envelope are secured between the upper plate and the holding plate. (10) The system of embodiment 1, wherein the indicator component further comprises a coupler.

[0137] (11) The system of embodiment 1, wherein the indicator component is attached to the durability component. (12) The system of embodiment 1, arranged and configured to be exposed to a body fluid source. (13) The system of embodiment 12, arranged and configured to be placed inside a diaper. (14) A handheld device comprising the system of embodiment 12. (15) A kit for measuring the concentration of an analyte in a body fluid, comprising: a) a durability component comprising a housing, the housing having at least one window and i) at least one spectrophotometer adjacent to and in optical communication with the window; ii) a computing system having at least one processor and a data storage device; and iii) means for electronic communication between the computing system and at least one external device, the durability component containing the same. b) A plurality of indicator components, each indicator component being encapsulated within an individual package and i) an indicator zone comprising at least one colorimetric analyte sensing element; ii) a coupler for the durability component, and an indicator component; c) at least one moisture sensor adjacent to the indicator zone; comprising; I) Each indicator component is arranged and configured to be releasably attached to the durability component while the indicator zone is 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 the at least one colorimetric analyte sensing element is associated with a spectrophotometer, a kit.

[0138] (16) The kit according to embodiment 15, wherein each indicator component further comprises a fluid transport layer in fluid communication with the indicator zone. (17) The kit according to embodiment 16, wherein each indicator component further comprises a fluid-impermeable envelope surrounding the indicator zone, the fluid-impermeable envelope having individual pockets arranged and configured to contain each of the at least one colorimetric analyte sensing element, each pocket having a unique opening in fluid communication with the fluid transport layer. (18) The kit according to embodiment 17, wherein the indicator zone comprises at least two colorimetric analyte sensing elements, each of the at least two colorimetric sensing elements being separated from the other colorimetric sensing elements. (19) The kit according to embodiment 18, wherein the at least one moisture sensor includes a plurality of moisture sensors, and each moisture sensor is arranged and configured to communicate the presence of moisture in each of the at least two colorimetric analyte sensing elements to the computing system. (20) Each indicator component iii) an upper plate, and iv) a first flexible web layer, and v) a fluid transport layer adjacent to the first flexible web layer, and vi) a fluid-impermeable envelope surrounding the indicator zone adjacent to the fluid transport layer, and vii) a second flexible web layer adjacent to the fluid-impermeable envelope, and viii) attachment means disposed on the second flexible web layer, and ix) a holding plate, and further comprising V) the first flexible web layer, the fluid transport layer, the fluid-impermeable envelope, and the second flexible web layer are stacked in sequence and secured between the upper plate and the holding plate, VI) the indicator zone comprises at least two colorimetric analyte sensing elements, VII) the fluid-impermeable envelope has individual pockets arranged and configured to contain each of the at least two colorimetric analyte sensing elements, each pocket having a unique opening in fluid communication with the fluid transport layer, VIII) the fluid transport layer is arranged and configured to prevent fluid transport between the openings within the fluid-impermeable envelope, the kit according to embodiment 15.

[0139] (21) The kit according to embodiment 20, wherein the upper plate and the holding 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. (22) The indicator component iii) a first flexible web layer, and iv) a fluid transport layer adjacent to the first flexible web layer, v) a fluid-impermeable envelope surrounding the indicator zone adjacent to the fluid transport layer, further comprising V) the first flexible web layer, the fluid transport layer, and the fluid-impermeable envelope are stacked in sequence and fixedly attached together, VI) the indicator zone comprises at least two colorimetric analyte sensing elements, VII) the fluid-impermeable envelope has individual pockets arranged and configured to contain each of the at least two colorimetric analyte sensing elements, and each pocket has a unique opening in fluid communication with the fluid transport layer, VIII) the fluid transport layer is arranged and configured to prevent fluid transport between the openings within the fluid-impermeable envelope, the kit according to embodiment 15. (23) vi) an upper plate adjacent to the first flexible web layer, vii) a holding plate, further comprising the first flexible web layer, the fluid transport layer, and the fluid-impermeable envelope are fixedly attached between the upper plate and the holding plate, the kit according to embodiment 22. (24) the durability component is coupled to a single non-packaged indicator component, the indicator component being arranged and configured to be exposed to a body fluid source, an assembled device. (25) arranged and configured to be placed into a diaper, the assembled device according to embodiment 24.

[0140] (26) the diaper is a diaper for infants, the assembled device according to embodiment 24. (27) a handheld device comprising the assembled device according to embodiment 24. (28) A method for measuring the concentration of an analyte in a body fluid, comprising a) Collecting a body fluid and transporting it to at least one colorimetric analyte sensing element; b) Detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element; c) After a predetermined period after detecting the presence of the body fluid in contact with the colorimetric analyte sensing element, collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer; 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 body fluid. A method comprising the steps of: (29) The method according to embodiment 28, wherein the body fluid is urine. (30) The method according to embodiment 29, wherein the analyte is selected from the group consisting of glucose, ketone, bilirubin, blood, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, and combinations thereof.

[0141] (31) A method for measuring the concentration of an analyte in a body fluid, comprising: a) Obtaining a durable component comprising a housing, the housing having at least one window and i) at least one spectrophotometer adjacent to and optically communicating with the window; ii) a computing system having at least one processor and a data storage device; iii) means for electronic communication between the computing system and at least one external device; iv) at least one moisture sensor; Obtaining, containing; b) Removing an indicator component from individual packages, the indicator component comprising an indicator zone comprising at least one colorimetric analyte sensing element; Removing; c) Coupling the indicator component to the durable component; I) The indicator zone is arranged 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 adjacent to the indicator zone and IV) Each of the at least one colorimetric analyte sensing element is associated with, coupled to, a spectrophotometer. d) Placing the assembly device in contact with a body fluid source. e) Collecting the body fluid and transporting it to the at least one colorimetric analyte sensing element. f) Detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element. g) After a predetermined period after detecting the presence of the body fluid in contact with the colorimetric analyte sensing element, collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer. 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 body fluid. A method comprising. (32) The method according to embodiment 31, wherein step (d) includes attaching the assembly device to a surface facing the body of the diaper. (33) The method according to embodiment 32, wherein step (d) includes bringing the assembly device into contact with the body fluid. (34) A method for predicting the risk of a future disease state, a) Collecting a body fluid and transporting it to at least one colorimetric analyte sensing element. b) Detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element. c) After a predetermined period after detecting the presence of the body fluid in contact with the colorimetric analyte sensing element, collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer; 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 at least one analyte concentration in the body fluid; f) Identifying a threshold analyte concentration of the at least one analyte in the body fluid that is an indicator of the risk of developing a future disease state; g) Recording the at least one analyte concentration in the body fluid over time. A method comprising: (35) The method according to embodiment 34, wherein the body fluid is urine.

[0142] (36) The method according to embodiment 34, wherein the analyte is selected from the group consisting of glucose, ketone, bilirubin, blood, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, and combinations thereof.

Claims

Claim 1 A method for measuring the concentration of an analyte in a body fluid, comprising: a) collecting the body fluid and transporting it to at least one colorimetric analyte sensing element; b) detecting the presence of the body fluid in contact with the at least one colorimetric analyte sensing element; c) after a predetermined period following detection of the presence of the body fluid in contact with the at least one colorimetric analyte sensing element, collecting optical data regarding the at least one colorimetric analyte sensing element using at least one spectrophotometer; 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 body fluid. Claim 2 The method according to claim 1, wherein the body fluid is urine. Claim 3 The method according to claim 2, wherein the analyte is selected from the group consisting of glucose, ketone, bilirubin, blood, protein, urobilinogen, nitrite, white blood cells, and / or creatinine, and combinations thereof.

Images