A disposable indicator component for measuring the concentration of an analyte in a body fluid

Abstract

A disposable indicator component for use in a system for measuring an analyte concentration in a bodily fluid includes an indicator region including at least one colorimetric analyte sensing element; and a coupler for coupling the indicator component to a component having at least one spectrophotometer housed within a housing.

Description

Background Technology Technical Field

[0002] This invention relates to a system for measuring changes in the concentration of analytes in bodily fluids. More specifically, this invention relates to a system for measuring the concentration of analytes in urine over time, and a method for measuring these analytes and detecting early-onset disease states in the human body.

[0003] Related technologies

[0004] Analytes present in bodily fluids (such as urine or sweat) may potentially carry evidence of metabolic system problems. People both inside and outside medical facilities want to track and analyze changes in the concentration of analytes in bodily fluids over time.

[0005] Currently, people and physicians rely on visible symptoms to diagnose systemic metabolic problems. This usually prompts a physician to perform a urinalysis or blood test to determine the presence or concentration of various analytes in these fluids. Therefore, in current practice, tests such as urinalysis are most often used to confirm symptom-based diagnoses rather than as initial identification of a disease. Some conditions, such as diabetic ketoacidosis, only show visible symptoms when the person's condition may already require an urgent visit to a physician. Other conditions, such as urinary tract infections, may not show visible symptoms and can lead to kidney scarring, which may not manifest as health problems until many years later.

[0006] Non-invasive measurement of analyte concentrations in urine is also ideally suited for epidemiological studies to rapidly identify prevalent problems in specific regions. However, difficulties in sample collection have hindered the acceleration of research in this field.

[0007] Absorbent products such as diapers contain embedded sensors that can only detect moisture. Typically, these sensors send the information to a receiving system. The receiving system then alerts caregivers to a one-time event. These moisture detection systems do not perform diagnostics.

[0008] Some existing diagnostic systems rely on urine analysis strips that are immersed in a urine sample and read manually or automatically by an imaging device or mobile phone. Other diagnostic systems rely on urine analysis strips attached to the outer surface of an absorbent material and read manually or automatically by an imaging device or mobile phone once wetted. In either case, data from the current reading can be compared with those from past and future readings.

[0009] In either method, urine analysis strips are read at the point in time after the strip has become wet with urine. Many of the chemicals used in the test strips are sensitive to exposure time, temperature, degree of wetting, etc. Therefore, obtaining accurate and repeatable readings is difficult.

[0010] In summary, the presence of analytes in bodily fluids may be evidence of metabolic system problems. It is desirable to track and analyze changes in the concentration of analytes in bodily fluids (such as urine) over time. However, for the data to be valuable, the readings must be accurate and repeatable. Summary of the Invention

[0011] We have developed a novel and usable disposable indicator component for use in systems for measuring the concentration of analytes in bodily fluids. The disposable indicator component includes an indicator region comprising at least one colorimetric analyte sensing element; and a coupler for coupling the indicator component to a component having at least one spectrophotometer housed within a housing.

[0012] A disposable indicator component for use with a handheld analyzer may include a first flexible mesh layer; a fluid delivery layer adjacent to the first flexible mesh layer; and a fluid-impermeable membrane surrounding an indicator region adjacent to the fluid delivery layer. The first flexible mesh layer, the fluid delivery layer, and the fluid-impermeable membrane are stacked and secured together in sequence, and the indicator region includes at least two colorimetric analyte sensing elements. Furthermore, the fluid-impermeable membrane has discrete pouches disposed thereon, configured to accommodate each of the at least two colorimetric analyte sensing elements, and each pouch has a single orifice in fluid communication with the fluid delivery layer. The fluid delivery layer is arranged and configured to inhibit fluid transport between the orifices in the fluid-impermeable membrane. Attached Figure Description

[0013] Figure 1 A top perspective view of the system used to measure the concentration of analytes in the absorbent article of the present invention;

[0014] Figure 2 for Figure 1 A decomposition diagram of the system;

[0015] Figure 3 for Figure 1 A cross-sectional view of the indicator component of the system;

[0016] Figure 4 for Figure 1 A top view of the durable components of the system;

[0017] Figure 5 For along Figure 4 A cross-sectional view of the durable component on plane 5-5;

[0018] Figure 6 for Figure 5 A cross-sectional view of the spectrophotometer section of the durable components;

[0019] Figure 7A top view of a moisture sensor element, which is an indicator component of a system used to measure the concentration of an analyte in an absorbent article as the moisture front passes through the element;

[0020] Figure 8 A capacitance-time plot of the moisture sensor element of the indicator component of the system as the moisture front passes through the system to measure the concentration of the analyte.

[0021] Figure 9 A top perspective view of the system used to measure the concentration of the analytes of the present invention;

[0022] Figure 10 for Figure 9 Bottom perspective view of the system used to measure analyte concentration;

[0023] Figure 11 for Figure 9 and Figure 10 An exploded view of the indicator components of the system;

[0024] Figure 12 For packaging Figure 11 A top perspective view of the colorimetric analyzer sensing element of the indicator component, where the fluid is impermeable to the membrane;

[0025] Figure 13 For packaged indicator components Figure 11 A top view of the fluid-impermeable membrane of the colorimetric analyzer sensing element;

[0026] Figure 14 for Figure 11 A top view of the partially assembled indicator components;

[0027] Figure 15 for Figure 11 A bottom view of the partially assembled indicator components;

[0028] Figure 16 for Figure 9 and Figure 10 Top perspective view of the durable components of the system;

[0029] Figure 17 for Figure 9 and Figure 10 A top view of the durable components of the system;

[0030] Figure 18 A top perspective view of the system used to measure the concentration of analytes in body fluids according to the present invention;

[0031] Figure 19 for Figure 18 Top perspective view of the indicator component of the system; and

[0032] Figure 20 for Figure 18 A partial decomposition diagram of the system. Detailed Implementation

[0033] This invention relates to a system for use in absorbent articles, which measures the concentration change of an analyte in a bodily fluid (such as urine) over time, a method for using the system to measure the concentration of an analyte in a bodily fluid over time, and a method for using the measurement results of the analyte over time to detect early-onset disease states in the human body.

[0034] The subject matter disclosed herein will now be described more fully below with reference to the accompanying drawings and embodiments. However, the subject matter disclosed herein may be embodied in various forms and should not be construed as being limited to any particular embodiment set forth herein or to the widest scope consistent with the features described herein. Rather, any characteristic embodiments are provided to make this disclosure thorough and complete, and to fully convey the scope of the invention to those skilled in the art to which it pertains. It is believed that those skilled in the art will be able to fully utilize the invention based on this specification.

[0035] 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 pertains. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety.

[0036] This invention relates to systems and methods that enable the monitoring of analyte concentrations in absorbable articles. The systems and methods also allow for statistical analysis and determination of changes in health status, which may be evidence of metabolic system problems, by collecting multiple data points over time. Other data, such as medical and family history, as well as current variables (such as age, temperature, and / or other current markers), can be used to supplement trend and statistical analysis.

[0037] Figures 1 to 6 An apparatus or system 10 for measuring the concentration of an analyte in an absorbent article is shown. The system 10 has an indicator component 20 and a durable component 100. Figure 1 This is a top perspective view of system 10 when fully assembled, and Figure 2 This is an exploded view of System 10.

[0038] Indicator component 20 in Figure 2 The view is shown as an exploded view, and in Figure 3The diagram is shown as a cross-sectional view. The indicator component 20 includes an indicator region 21 with a colorimetric analyte sensing element 30, which may be disposed in an optional second flexible mesh 40, a fluid delivery layer 50, an optional first flexible mesh 60, an optional top plate 70, a coupler shown herein as a retaining plate 80, and an adhesive layer 90. The indicator component 20 is preferably disposable.

[0039] The colorimetric analyte sensing element 30 has perforations 36 and is disposed within the openings 46 of the second flexible mesh 40. In some embodiments, the colorimetric analyte sensing element 30 is a reagent-impregnated matrix designed to generate a visual indication of the presence of a preselected analyte in a sample generated by the wearer of the system 10. Chemicals and methods for detecting analytes by generating visual indications are well known in the art. In some embodiments, the preselected analytes measured by the system 10 may be glucose, ketones, bilirubin, blood, pH, proteins, urobilinogen, nitrite, leukocytes, and / or creatinine, etc.

[0040] For example, the absorbent material may be a diaper, the fluid being tested may be urine, and the preselected analyte measured by system 10 may be glucose. Glucose in urine, or glucose in urine, is the presence of sugar in urine at levels higher than normal and may be due to a person's kidneys or complications of diabetes. Some of the most common causes of glucose in urine include diabetes, hyperthyroidism, benign glycosuria, cirrhosis, or a high-sugar diet. Furthermore, in some embodiments, those skilled in the art will recognize that selecting appropriate biosensors capable of translating preferred biomarkers into calorimetrically readable results can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers in urine.

[0041] As mentioned, the colorimetric analyte sensing element 30 is disposed in the opening 46 of the second flexible mesh 40 and is in fluid communication with the fluid delivery layer 50. The fluid delivery layer 50 is in fluid communication with the first flexible mesh 60. The second flexible mesh 40 has a first side 42 and is made of a non-absorbent material, such as polyethylene foam. The fluid delivery layer 50 has a first side 52 and perforations 56 and is made of a wicking material, such as fabric or paper, which is capable of effectively diffusing and delivering fluid via capillary action. The first flexible mesh 60 has a first side 62 and perforations 66 and is made of a non-absorbent open-cell membrane, such as a polyethylene mesh.

[0042] The second flexible mesh 40, the fluid delivery layer 50, and the first flexible mesh 60 are designed to facilitate the delivery of fluid to the colorimetric analyte sensing element 30. In use, fluid from the absorbable article first contacts the first side 62 of the first flexible mesh 60. Because the first flexible mesh 60 is a non-absorbent open-pore membrane, the fluid passes through the first flexible mesh 60 and contacts the first side 52 of the fluid delivery layer 50. The fluid then permeates the entire fluid delivery layer 50. The fluid will then contact the first side 42 of the second flexible mesh 40. However, because the second flexible mesh 40 is made of a non-absorbent material, the fluid in the delivery layer 50 does not penetrate the second flexible mesh 40. Finally, the fluid in the delivery layer 50 comes into contact with the colorimetric analyte sensing element 30.

[0043] The sensing element 30 is disposed in the second flexible mesh 40, and the fluid delivery layer 50 and the first flexible mesh 60 are stacked, as shown. Figures 1 to 3 As shown, the components are held together by a top plate 70 and a retaining plate 80. The retaining plate 80 has a pin 88. The pin 88 passes successively through a perforation 36 in the colorimetric analyzer sensing element 30, a perforation 56 in the fluid delivery layer 50, and a perforation 66 in the first flexible mesh 60. Although not shown, the top plate 70 has a blind hole in which the pin 88 is disposed. The frictional engagement between the blind hole in the top plate 70 and the pin 88 holds the components of the indicator component 20 together. Alternatively, the components may be held together by other interactions, such as snap-fit, ultrasonic welding, thermal welding, or other mechanical fasteners.

[0044] The top plate and retaining plate are arranged and configured to provide a predetermined spacing to accommodate a layer of indicator components with a predetermined fluid delivery capacity into the indicator area. This provides a more controlled delivery of fluid to the indicator area, and the correlation timing between the fluid arriving in the indicator area and the colorimetric measurement results is described in more detail below.

[0045] The top plate 70 may have channels on its side facing the first side 62 of the first flexible mesh 60. The channels can help guide fluid from the absorbent article to the first side 62 of the first flexible mesh 60.

[0046] Durable parts 100 Figure 2 The top perspective view is shown as an exploded view. Figure 4 The image is shown as a top view. Figure 5 The diagram is shown as a sectional view, and... Figure 6 The image is shown as an enlarged cross-sectional view. The durable component 100 has a housing 102 with a window 104. A spectrophotometer is disposed within the housing 102. Components of the spectrophotometer include a light source 122 and a photodetector 124. The spectrophotometer is adjacent to and optically communicates with the window 104. This allows the spectrophotometer to optically communicate with the colorimetric analyte sensing element 30 of the indicator component 20.

[0047] like Figure 2As shown, the spectrophotometer includes two light sources 122 and a photodetector 124. If desired, the spectrophotometer may include at least one or more light sources 122 and at least one photodetector 124, for example, at least two or more light sources 122 and at least two or more photodetectors 124.

[0048] Figure 2 Also shown is a male connector protrusion 106 surrounding the window 104 on the housing 102. The male connector protrusion 106 allows the durable part 100 to be releasably attached to the indicator part 20.

[0049] Figure 4 This is a top view of the durable component 100 of system 10. Conductive strips 108a and 108b are disposed on the top surface of the male connector protrusion 106 and, as described below, act as moisture sensors, arranged and configured to transmit the presence of moisture in the colorimetric analyzer sensing element 30 to a computing system disposed in the durable component 100.

[0050] Figure 4 and Figure 5 Two light sources 122 and a photodetector 124 are also shown linearly arranged and evenly spaced in the system 10. The spacing can be achieved in other ways, such as by having multiple light sources 122 evenly arranged in a square or circle around the photodetector 124.

[0051] Figure 5 and Figure 6 This is a cross-sectional view of durable component 100. Figure 5 The housing 102, window 104, male connector protrusion 106, conductive strips 108a and 108b, and printed circuit board (PCB) 120 are shown. Figure 6 It is an enlargement of the area of ​​the component housing the spectrophotometer in the durable component 100.

[0052] The conductive traces, pads, and other features etched from the laminated copper sheet onto the non-conductive substrate on the PCB 120 mechanically support and electrically connect electronic components. Components (e.g., capacitors, resistors, controllers, power sources, light sources, detectors) are typically soldered onto the PCB 120. The PCB 120 has a computing system 140 with one or more processors and memory, as well as a device 150 for electronic communication to transmit the results of analysis to a data processing system external to the system 10. The data processing system that can be used includes at least one external device, such as a server computer, client computer, and handheld device, such as a mobile phone.

[0053] Figure 5A PCB 120 is shown supported within a housing 102 of a durable component 100 by means of a support bracket 110. In other embodiments, the PCB 120 may be directly attached to the inner surface of the housing 102.

[0054] Figure 6 This is an enlarged view of the area of ​​the durable component 100 that houses the spectrophotometer. The light source 122 and photodetector 124 for 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), terminating at both ends on the surface of the PCB 120 and the inner surface of the housing 102 of the durable component 100. A skirt-like portion 128 is attached to the surface of the PCB 120 and serves to optically separate the photodetector 124 from the light source 122. Therefore, in operation, without reflection from the colorimetric analyte sensing element 30, light emitted from the light source 122 cannot be projected onto the photodetector 124.

[0055] Alternatively, a lens can be placed above the light source 122 so that, during operation, light emitted from the light source 122 cannot be projected onto the photodetector 124 without reflection from the colorimetric analyte sensing element 30. Encapsulating material can also be used to focus light from the light source 122 onto the colorimetric analyte sensing element 30.

[0056] Figure 6 Illumination chamber 130 is also shown. Illumination chamber 130 is a volume enclosed by the surface of PCB 120, ambient light shielded by shielding member 126, male connector protrusion 106, conductive strip 108b, and colorimetric analyzer sensing element 30. Indicator area 21 is the area of ​​indicator component 20 in which colorimetric analyzer sensing element 30 is exposed to light source 122.

[0057] Although the two light sources 122 are in Figure 5 and Figure 6 As is evident, the durable component 100 may have multiple light sources 122, such as four light sources evenly spaced around the device. The light sources 122 may be light-emitting diodes (LEDs), which are semiconductor light sources that emit light when current flows through them. LEDs have many advantages over incandescent light sources, including lower energy consumption, longer lifespan, improved physical robustness, smaller size, and faster switching. In the embodiments discussed herein, the light source 122 is an RGB LED. Mixing red, green, and blue sources can produce white light with appropriate color blending. Furthermore, the color emitted from an RGB LED can be monochromatic, thereby allowing data to be obtained in a narrow wavelength range.

[0058] The photodetector 124 is also referred to as a photoelectric sensor. A photodetector is a sensor of light or other electromagnetic radiation. The photodetector has a pn junction that converts photons into an electric current. 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 discussed herein, the photodetector 124 specifically measures red, green, and blue light, thereby allowing data to be obtained in a narrow wavelength range (note: in...). Figure 6 In the image, “R”, “G” and “B” are located above photodetector 124.

[0059] In system 10 for measuring the concentration of an analyte in an absorbent article, light source 122 emits light with 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, source 122 emits red, green, and blue light sequentially, allowing for the simultaneous collection of three data points. In other embodiments, the sequence of emitted red, green, and blue light can be varied.

[0060] The components of the spectrophotometer may be coated with a protective material. The protective material prevents moisture from coming into contact with the colorimetric analyte sensing element 30 and from potentially damaging the components of the spectrophotometer.

[0061] The indicator component 20 is arranged and configured for releasable attachment to the durable component 100. When assembled, the colorimetric analyzer sensing element 30 is disposed adjacent to the window 104 and optically communicates with the window 104 and the elements of the spectrophotometer.

[0062] Figures 4 to 6 Conductive strips 108a and 108b are also shown on the top surface of the male connector protrusion 106. Conductive strips 108a and 108b function as moisture sensors in system 10 and are arranged and configured to transmit the presence of moisture in the colorimetric analyzer sensing element 30 to a computing system disposed in the durable component 100. The computing system disposed in the durable component 100 is then operatively connected to components of the moisture sensor and the spectrophotometer.

[0063] like Figure 6 As shown, conductive strips 108a and 108b are adjacent to the colorimetric analyzer sensing element 30. When moisture is projected onto the colorimetric analyzer sensing element 30, it will also contact portions of conductive strips 108a and 108b.

[0064] Figure 7 and Figure 8 The functions of conductive strips 108a and 108b in the moisture sensor of system 10 are described. Figure 7This is a top view at several time points during the progression of the moisture front across conductive strips 108a and 108b. The progression of the front is shown as AA, BB, CC, and DD. At time point AA, the moisture front has partially progressed across conductive strips 108a and 108b. Further progress across strips 108a and 108b is shown as time points BB and CC, while DD shows the time point when the moisture front has completely crossed strips 108a and 108b.

[0065] Figure 8 An example of the change in electrical properties between bars 108a and 108b is shown when the moisture front crosses the bars. In this embodiment, Figure 8 The capacitance versus time plot is shown as the moisture front passes through strips 108a and 108b. Figure 8 Line A corresponds to time point AA, where the moisture front has partially advanced across conductive strips 108a and 108b. Capacitance is shown as increasing with line B at time points BB and CC, indicating further advancement across strips 108a and 108b, and then increasing with line C. Finally, line D, where capacitance is shown as the level corresponding to time point DD, where the moisture front has completely crossed strips 108a and 108b. At point DD, the colorimetric analyte sensing element 30 is completely saturated with moisture.

[0066] Although capacitance is discussed in this embodiment, other electrical properties, such as resistance, will also vary as the moisture front progresses across strips 108a and 108b.

[0067] The aforementioned moisture sensing system allows the spectrophotometer to read the emitted light waves reflected from the colorimetric analyte sensing element 30 at a specific point in time after the strip has become moistened. This solves the problem of the chemicals used in the test strip being sensitive to time, temperature, and degree of wetting, thus allowing for accurate and repeatable readings.

[0068] In a preferred embodiment, the plurality of light sources 122 are four narrow-beam LEDs spaced around the photodetector 124. Therefore, the onset of wetting can be detected by the impedance change of the conductive strips 108a and 108b. The accuracy of sufficient penetration initiation 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. If there are significant differences in the data returned by the photodetector 124 due to different narrow-beam LEDs, the colorimetric analyte sensing element 30 may not be sufficiently penetrated for reliable analysis. Therefore, in this embodiment, the system can begin collecting optical data associated with the colorimetric analyte sensing element 30, such as that determined by (1) the impedance change of the conductive strips 108a and 108b and (2) the relatively consistent data returned by the photodetector 124 (due to the different narrow-beam LEDs indicating substantially uniform wetting of the colorimetric analyte sensing element 30), after a predetermined time period following contact of the bodily fluid with the colorimetric analyte sensing element 30.

[0069] Although the above embodiment is an embodiment of system 10 for measuring the concentration of an analyte in an absorbent article having an indicator component 20 and a durable component 100, it is envisioned that in some cases, the durable component 100 can be combined with multiple indicator components 20 to create a kit for measuring the concentration of an analyte in an absorbent article. The kit has at least one, preferably one or more, separately packaged indicator components 20. This allows the kit to measure the concentration of the analyte in the absorbent article once or multiple times daily, weekly, monthly, or even daily, weekly, or monthly. When used in this manner, system 10 is used to track changes in the measured analyte concentration over several days, weeks, months, or even years.

[0070] The disposable absorbent products used in the system 10 for measuring analyte concentrations include absorbent hygiene products such as diapers (including baby diapers, training pants, and adult incontinence products) and pads (including feminine hygiene pads, panty liners, and nursing pads).

[0071] For example, the absorbent article used in 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 couple the indicator component 20 of system 10 to the fluid delivery layer of the diaper. System 10 can be attached to the body-facing surface of the diaper. Other attachment means will be apparent and, without limitation, include mechanical fasteners such as clamps, grippers, hook and loop systems, and belts; magnetic (including electrostatic); frictional; etc. The indicator component can be arranged and configured for releasable attachment to the diaper.

[0072] Systems used to measure the concentration of analytes in absorbent articles can have multiple colorimetric analyte sensing elements. Figures 9 to 17 A system for measuring the concentration of an analyte in an absorbent article of the present invention is shown. The system 200 has an indicator component 220 and a durable component 300. Figure 9 and Figure 10 These are the top and bottom when the system 200 is fully assembled.

[0073] Indicator component 220 in Figure 11 The diagram is shown in an exploded view. The indicator component 220 includes an indicator area 221 with a colorimetric analyte sensing element, 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 and a second side 234a, and a through-hole 236a. The second colorimetric analyte sensing element 230b has a first side 232b and a second side 234b, and a through-hole 236b.

[0074] The colorimetric analyte sensing elements 230a and 230b may be reagent-impregnated matrices designed to generate a visual indication of the presence of a preselected analyte in a sample generated by the wearer of system 200. Chemicals and methods for detecting analytes by generating visual indications are well known in the art. Preselected analytes measured by system 200 may include glucose, ketones, bilirubin, blood, pH, proteins, urobilinogen, nitrite, leukocytes, and / or creatinine, etc.

[0075] The colorimetric analyte sensing elements 230a and 230b can be designed to generate visual indications of the presence of the same pre-selected analyte in samples generated by the wearer of system 200. In this case, the colorimetric analyte sensing elements 230a and 230b serve to confirm the analysis. The colorimetric analyte sensing elements 230a and 230b can also be designed to generate visual indications of the presence of different pre-selected analytes in samples generated by the wearer of system 200.

[0076] Similarly, the absorbent material can be a diaper, the fluid being tested is urine, and the preselected analyte measured by system 200 is glucose. Glucose in urine, or glucose in urine, is the presence of sugar in the urine at levels higher than normal, and may be due to a person's kidneys or complications of diabetes.

[0077] Ketones can also be a preselected analyte measured by System 200. If cells in the body don't get enough glucose, the body will turn to burning fat for energy. This produces ketones, which can appear in the blood and urine. High ketone levels in urine can indicate diabetic ketoacidosis (DKA), a complication that can lead to coma or even death.

[0078] Some of the most common causes of glucose or ketones in urine include diabetes, hyperthyroidism, benign glycosuria, cirrhosis, or a high-sugar diet. Furthermore, in some embodiments, those skilled in the art will recognize that selecting appropriate biosensors capable of translating preferred biomarkers into calorimetrically readable results can also be used in genomics, transcriptomics, metabolomics, and proteomics to determine the presence of inflammatory biomarkers in urine.

[0079] Other components of the indicator component 220 include an optional top plate 270, an optional first flexible mesh 260, a fluid delivery layer 250, a second flexible mesh 240, an adhesive layer 290, and a coupler as shown herein as a retaining plate 280.

[0080] Colorimetric analysis sensing elements 230a and 230b are encapsulated between a first encapsulation layer 410 and a second encapsulation layer 430 to form a fluid-impermeable membrane 431. The first encapsulation layer 410 has a first side 412 and a second side 414, as well as a through-hole 416 and an aperture 418. The second encapsulation layer 430 has a first side 432 and a second side 434, as well as a through-hole 436 and an aperture 438.

[0081] Figure 12 This is a top perspective view of the fluid-impermeable encapsulation 431 of the colorimetric analysis sensing elements 230a and 230b of the indicator component 220 of the encapsulation system 200. Figure 13 The package is shown. Figure 12 A top view of the fluid-impermeable encapsulation 431 of the colorimetric analyzer sensing element. The figure shows the first side 432, perforation 436, and orifice 438 of the second encapsulation layer 430 in solid lines. The figure shows the colorimetric analyzer sensing elements 230a, 230b, their first sides 232a, 232b, and perforations 236a, 236b, as well as the orifice 418 of the first encapsulation layer 410 in dashed lines. The dashed lines showing the colorimetric analyzer sensing elements 230a, 230b also depict the discrete pouch 433 formed when the first encapsulation layer 410 and the second encapsulation layer 430 are sealed together at their surface contact points. Figure 13 (One of the two shown).

[0082] During assembly, the first perforation 436 of the second encapsulation layer 430 is aligned with the perforations 236a and 236b of the colorimetric analyzer sensing elements 230a and 230b, and with the perforation 416 (not shown) of the first encapsulation layer 410. Furthermore, the aperture 438 of the second encapsulation layer 430 is aligned with the aperture 418 of the first encapsulation layer 410.

[0083] A fluid-impermeable membrane 431 encapsulates the colorimetric analyte sensing elements 230a and 230b of the indicator component 220 of the system 200, which are disposed on the fluid delivery layer 250. This partially assembled indicator component of the system 200 is displayed... Figure 14 In the top view and Figure 15 In the bottom view. Figure 14 The first side 252, the first perforation 256, and the second perforation 258 of the fluid delivery layer 250 are shown in solid lines. The accompanying drawings show colorimetric analyte sensing elements 230a and 230b, their first sides 232a and 232b, and perforations 236a and 236b, as well as the orifice 418 of the first encapsulation layer 410 and the first side 432 and orifice 438 of the second encapsulation layer 430, all shown in dashed lines.

[0084] Figure 15 The second side 252 of the fluid delivery layer 250, the second side 414 of the first encapsulation layer 410, the perforation 416, and the aperture 418 are shown in solid lines. The accompanying drawings show colorimetric analyte sensing elements 230a and 230b, their second sides 234a and 234b, and perforations 236a and 236b, as well as the second perforation 258 of the fluid delivery layer 250, in dashed lines.

[0085] The second flexible mesh 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. A fluid-impermeable membrane 431 encapsulating the colorimetric analyte sensing elements 230a and 230b is disposed on the second flexible mesh 240, specifically within the opening 246 of the second flexible mesh 240, and is in fluid communication with the fluid delivery layer 250. The fluid delivery layer 250 is then in fluid communication with the first flexible mesh 260. The first flexible mesh 260 has a first side 262 and a perforation 266, and is made of a non-absorbent open-cell membrane, such as a polyethylene mesh.

[0086] The second flexible mesh 240, the fluid delivery layer 250, and the first flexible mesh 260 are designed to control the delivery of bodily fluids to the colorimetric analyte sensing elements 230a and 230b and to limit cross-contamination of fluids within different colorimetric analyte sensing elements. In use, fluid from the absorbable article first contacts the first side 262 of the first flexible mesh 260. Because the first flexible mesh 260 is a non-absorbent open-pore membrane, the fluid passes through the first flexible mesh 260 and contacts the first side 252 of the fluid delivery layer 250. The fluid then permeates the entire fluid delivery layer 250. The fluid will then contact the first side 242 of the second flexible mesh 240. However, because the second flexible mesh 240 is made of a non-absorbent material, the fluid in the delivery layer 250 does not penetrate the second flexible mesh 240. Finally, the fluid in the delivery layer 250 passes through the orifices 438 of the second encapsulation layer 430 to contact the colorimetric analyte sensing elements 230a and 230b. Cross-contamination between the two colorimetric analyte sensing elements is eliminated or at least rendered insignificant and cannot be detected by means of the fluid barrier defined by the capillary gap within the fluid delivery layer 250 provided by the second perforation 258.

[0087] Sensing elements 230a and 230b, a first encapsulation layer 410, a second encapsulation layer 430, a second flexible mesh 240, a fluid transport layer 250, and a first flexible mesh 260 are stacked, as shown. Figure 11 As shown, the components are held together by a top plate 270 and a retaining plate 280. The top plate 270 has a pin 278. The pin 278 passes successively through a perforation 266 of the first flexible mesh 260, a perforation 256 of the fluid delivery layer 250, a perforation 416 of the first encapsulation layer 410, perforations 236a and 236b of the colorimetric analyzer sensing elements 230a and 230b, a first perforation 436 of the second encapsulation layer 430, an opening 246 of the second flexible mesh 240, and is finally disposed in a blind hole 286 of the retaining plate 280. The frictional engagement between the top plate pin 278 and the blind hole 286 holds the components of the indicator component 220 together. Alternatively, the components may be held together by other interactions, such as snap-fit, ultrasonic welding, thermal welding, or other mechanical fasteners.

[0088] The top plate 270 may have one or more channels on its side facing the first side 262 of the first flexible mesh 260. The one or more channels may help guide fluid from the absorbent article to the first side 262 of the first flexible mesh 260.

[0089] The indicator component 220 may have an attachment means, such as an adhesive layer 290. The adhesive layer 290 has a first side 292 and is used to attach or couple the indicator component 220 of the system 200 to the fluid delivery layer of the absorbent article (such as a diaper).

[0090] The system's durable components 300 Figure 16The top perspective and in Figure 17 The image is shown in top view. The durable component 300 has a housing 302 with a pair of windows, namely a first window 304a and a second window 304b. The durable 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 optically communicates with the first window 304a. Components of the first spectrophotometer include a light source 322a and a photodetector 324a. The first spectrophotometer is optically communicated with a colorimetric analyte sensing element 230a. The second spectrophotometer is adjacent to and optically communicates with the second window 304b. Components of the second spectrophotometer include a light source 322b and a photodetector 324b. The second spectrophotometer is optically communicated with the colorimetric analyte sensing element 230b. Although the durable component 300 shows two spectrophotometers, additional spectrophotometers may be included for measuring additional analytes or fluid conditions, such as pH, temperature, etc. Indicator area 221 is the area of ​​indicator component 220 in which colorimetric analyzer sensing element 230a is exposed to light source 322a.

[0091] Although not shown, durable component 300 also includes a printed circuit board (PCB) with a computing system having one or more processors and memory, as well as means for electronic communication to send the results of the analysis to a data processing system external to system 200. The data processing system that can be used includes at least one external device, including server computers, client computers, and handheld devices such as mobile phones.

[0092] like Figure 16 and Figure 17 As shown, the first and second spectrophotometers may include four light sources 322a and 322b, and each spectrophotometer has a photodetector 324a and 324b. Each spectrophotometer may have at least one light source 322a and 322b associated with it. Each spectrophotometer may include at least six or more light sources 322a and 322b. As previously described, the light sources 322a and 322b may be light-emitting diodes (LEDs), and more specifically RGBLEDs. The light sources 322a and 322b may emit red, green, and blue light sequentially, thereby allowing for the near-simultaneous collection of three data points, or the sequence of emitted red, green, and blue light may be varied.

[0093] As previously discussed, the photodetectors in spectrometers 324a and 324b can specifically measure red, green, and blue light, thus allowing data to be obtained in a narrow wavelength range. Light waves emitted from light source 322a are reflected from colorimetric analyte sensing element 230a and measured by photodetector 324a. Light waves emitted from light source 322b are reflected from colorimetric analyte sensing element 230b and measured by photodetector 324b. Components of the spectrophotometer may be coated with a protective material. This protective material prevents moisture from contacting the colorimetric analyte sensing elements 230a and 230b and potentially damaging the components of the spectrophotometer.

[0094] Figure 16 and Figure 17 A connector 310 disposed on the housing 302 is also shown. The connector 310 includes a standard spring-loaded clamp 312 biased to hold the clamp 312 to the housing 302 of the durable component 300. Figure 11 As shown, retaining plate 280 has a receiving element 286 disposed therein. To releasably attach durable component 300 to retaining plate 280, clamp 312 is secured to receiving element 286. This means durable component 300 is releasably attached to indicator component 220. Other attachment devices will be apparent, and are not limited to mechanical fasteners such as clamps, hook and loop systems, threaded orifices, bayonet couplers, strips, straps, and bands; magnetic (including electrostatic); frictional; etc.

[0095] Figure 17 Conductive strips 308a, 308b, 308c, and 308d are also shown disposed on the top surface 306 of the durable component 300. The conductive strips 308a, 308b, 308c, and 308d serve as moisture sensors, arranged and configured to transmit the presence of moisture in the colorimetric analysis sensing elements 230a and 230b to a computing system disposed within the durable component 300. Figure 17 As shown, conductive strips 308a and 308b are associated with the first window 304a and the colorimetric analyte sensing element 230a. Conductive strips 308c and 308d are associated with the second window 304b and the colorimetric analyte sensing element 230b. A computing system disposed in the durable component 300 is operatively connected to components of the humidity sensor and the spectrophotometer.

[0096] Conductive strips 308a and 308b are adjacent to the colorimetric analyzer sensing element 230a. When moisture is projected onto the colorimetric analyzer sensing element 230a, it will also contact portions of conductive strips 308a and 308b. Conductive strips 308c and 308d are adjacent to the colorimetric analyzer sensing element 230b. When moisture is projected onto the colorimetric analyzer sensing element 230b, it will also contact portions of conductive strips 308c and 308d.

[0097] The operating mode of conductive strips 308a, 308b, 308c, and 308d as moisture sensors is the same as that of conductive strips 108a and 108b, such as... Figure 7 and Figure 8 As described in [the text]. The moisture front progresses partially and eventually crosses completely across conductive strips 308a and 308b, as well as 308c and 308d. Systems for measuring analyte concentrations in bodily fluids can be used in absorbent articles, or can be in direct contact with bodily fluids outside of absorbent articles. For example, the system can contact bodily fluids collected in a sample container, or it can contact bodily fluids such as urine as fluids are expelled from the body. Figures 18 to 20 A system for measuring the concentration of analytes in bodily fluids according to the present invention is shown. The system 500 has an indicator component 520 and a durable component 600. Figure 18 This is a top perspective view when the system 500 is fully assembled. Figure 19 Top perspective view of indicator component 520 of system 500. Figure 20 This is a partial exploded view of system 500, in which indicator component 520 is shown in an exploded view.

[0098] exist Figure 20 In the diagram, indicator component 520 includes an indicator area 521 shown as having a colorimetric analyte sensing element, 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 532a and a perforation 536a. The second colorimetric analyte sensing element 530b has a first side 532b and a perforation 536b.

[0099] As previously described, the colorimetric analyte sensing elements 530a and 530b may be reagent-impregnated matrices designed to generate a visual indication of the presence of a preselected analyte in a sample generated by the user of system 500. The preselected analytes measured by system 500 may include glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, leukocytes, and / or creatinine, etc.

[0100] Similarly, colorimetric analyte sensing elements 530a and 530b can be designed to indicate the presence of the same preselected analyte in samples generated by the user of system 500. In this case, colorimetric analyte sensing elements 530a and 530b serve to confirm the analysis. Colorimetric analyte sensing elements 530a and 530b can also be designed to generate visual indications of the presence of different preselected analytes in samples generated by the user of system 500.

[0101] Similarly, the fluid being tested can be urine, and the pre-selected analytes measured by System 500 are 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 complications of the user's kidneys or other conditions such as diabetes, hyperthyroidism, benign glycosuria, cirrhosis, or a high-sugar diet.

[0102] In addition, selecting appropriate biosensors capable of converting preferred biomarkers into calorimetrically readable results can also be used in genomics, transcriptomics, metabolomics, and proteomics to identify the presence of inflammatory biomarkers in urine or other body fluids.

[0103] Other components of the indicator component 520 include a top plate 570, a first flexible mesh 560, a fluid delivery layer 550, a first encapsulation layer 710, a second encapsulation layer 730, and a coupler shown herein as a retaining plate 580.

[0104] Colorimetric analysis sensing elements 530a and 530b are encapsulated between a first encapsulation layer 710 and a second encapsulation layer 730 to form a fluid-impermeable membrane 731. The first encapsulation layer 710 has a first side 712, a through-hole 716, and an aperture 718. The second encapsulation layer 730 has a first side 732, a through-hole 736, and an aperture 738.

[0105] When assembled in the indicator component 520, the perforations 716 of the first encapsulation layer 710 are aligned with the perforations 536a and 536b of the colorimetric analyzer sensing elements 530a and 530b, and the perforation 736 of the second encapsulation layer 730. Furthermore, the apertures 718 of the first encapsulation layer 710 are aligned with the apertures 738 of the second encapsulation layer 730.

[0106] Figure 20 A fluid delivery layer 550 and a first flexible mesh 560 are also shown. When assembled in the indicator component 520, the fluid delivery layer 550 is disposed on the encapsulated colorimetric analyte sensing elements 530a, 530b of the indicator component 520 of the system 500. The fluid delivery layer 550 has a first side 552, a first perforation 556, and a second perforation 558. The first flexible mesh 560 is disposed on the fluid delivery layer 550 and has a first side 562 and a perforation 566, and is made of a non-absorbent open-cell membrane, such as a polyethylene mesh.

[0107] When assembled in indicator component 520, colorimetric analyte sensing elements 230a and 230b, encapsulated in a fluid-impermeable membrane 731, are in fluid communication with fluid delivery layer 550. Fluid delivery layer 550 is then in fluid communication with first flexible mesh 560.

[0108] The fluid delivery layer 550 and the first flexible mesh 560 are designed to control the delivery of bodily fluids to the colorimetric analyte sensing elements 530a and 530b and to limit cross-contamination of fluids within the different colorimetric analyte sensing elements. In use, the bodily fluid first contacts the first side 562 of the first flexible mesh 560. Since the first flexible mesh 560 is a non-absorbent open-pore membrane, the fluid passes through the first flexible mesh 560 and contacts the first side 552 of the fluid delivery layer 550. The fluid then permeates the entire fluid delivery layer 550. Finally, the fluid in the delivery layer 550 passes through the orifice 738 of the second encapsulation layer 730 to contact the colorimetric analyte sensing elements 530a and 530b. Similarly, cross-contamination between the two colorimetric analyte sensing elements is eliminated or at least rendered insignificant and cannot be detected by means of the fluid barrier defined by the capillary gaps within the fluid delivery layer 550 provided by the second perforation 558.

[0109] Sensing elements 530a, 530b, a first encapsulation layer 710, a second encapsulation layer 730, a fluid transport layer 550, and a first flexible mesh 560 are stacked, as shown in the image. Figure 20 As shown, the components are held together by a top plate 570 and a retaining plate 580. The top plate 570 has a pin 578. The pin 578 passes successively through a perforation 566 of the first flexible mesh 560, a perforation 556 of the fluid delivery layer 550, a perforation 716 of the first encapsulation layer 710, perforations 536a and 536b of the colorimetric analyzer sensing elements 530a and 530b, a perforation 736 of the second encapsulation layer 730, and is finally disposed in a blind hole 586 on the first side 582 of the retaining plate 580. The frictional engagement between the top plate pin 578 and the blind hole 586 holds the components of the indicator component 520 together. Alternatively, the components may be held together by other interactions, such as snap-fit, ultrasonic welding, thermal welding, or other mechanical fasteners.

[0110] The top plate 570 has orifices 576 that facilitate the guidance of fluid to a first side 562 of the first flexible mesh 560. The top plate 570 also has protrusions 575 thereon. The protrusions 575, and the protrusions 587 thereon on the retaining plate 580, are means for attaching the indicator component 520 to the durable component 600 of the system 500.

[0111] Durable parts 600 Figure 20 As shown in the top perspective view. The durable component 600 with 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). The durable component 600 also has a flat top surface 606, conductive rings 608a and 604b, a receiving element 605, a protrusion 610, an activation button 650, and a finger grip 660.

[0112] Although not shown, a pair of spectrophotometers are disposed in housing 602. A first spectrophotometer is adjacent to and optically communicates with a first window 304a, while a second spectrophotometer is adjacent to and optically communicates with a second window 304b. The first spectrophotometer optically communicates with a colorimetric analyte sensing element 530a, and the second spectrophotometer optically communicates with a colorimetric analyte sensing element 530b. Although two spectrophotometers are shown in the durable component 600, additional spectrophotometers may be included for measuring additional analytes or fluid conditions, such as pH, temperature, etc. Indicator area 521 is the area of ​​indicator component 520 in which the colorimetric analyte sensing element 530a is exposed to one or more light sources.

[0113] 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 means for electronic communication to send the results of the analysis to a data processing system external to system 500. The data processing system that can be used includes at least one external device, including server computers, client computers, and handheld devices such as mobile phones.

[0114] As discussed in other embodiments of this document, the 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. Furthermore, as previously described, the light source in durable component 600 may be a light-emitting diode (LED), and more specifically an RGB LED. The light source may emit red, green, and blue light sequentially, thereby allowing for the near-simultaneous collection of three data points, or the sequence of emitted red, green, and blue light may be varied.

[0115] As previously discussed, the photodetectors of the durable component 600 can also specifically measure red, green, and blue light, thus allowing data to be obtained in a narrow wavelength range, and can be coated with protective materials to reduce the possibility of damage to their components.

[0116] Figure 18 A top perspective view of the durable component 600 and indicator component 520 assembled to form system 500 is shown. Here, the indicator component 520 is disposed on the distal end 630 of the durable component 600. The top plate 570 of the durable component 600 has a protrusion 575, and the retaining plate 580 has a protrusion 587. The durable component 600 has a receiving element 605 and a protrusion 610. In order to releasably attach the indicator component 520 to the durable component 500, the protrusion 575 of the top plate 570 is disposed in the receiving element 605 of the durable component 600. Then, the protrusion 587 of the retaining plate 580 engages with the protrusion 610 of the durable component 600.

[0117] Figure 20 Conductive strips 608a and 608b are shown disposed on the top surface 606 of the durable component 600. Conductive strips 608a and 608b serve as moisture sensors in the system 500. They are arranged and configured to transmit the presence of moisture in colorimetric analyte sensing elements 530a and 530b to a computing system disposed in the durable component 600. In this embodiment, conductive strip 608a is associated with a first window 604a and a colorimetric analyte sensing element 530a. Conductive strip 608b is associated with a second window 604b and a colorimetric analyte sensing element 530b. The computing system disposed in the durable component 600 is operatively connected to the moisture sensors and components of a spectrophotometer.

[0118] The operating mode of conductive strips 608a and 608b as moisture sensors is the same as that of conductive strips 108a and 108b, such as... Figure 7 and Figure 8 As described in the text. The moisture front partially advances and eventually crosses completely across conductive strips 608a and 608b.

[0119] Durable components can be matched with multiple indicator components to create a kit for measuring the concentration of analytes in absorbent articles. For example, a kit may have durable components 100, 300, 600 (described above) and multiple indicator components 20, 220, 520 (also described above). To ensure the integrity of the indicator components during storage, each such indicator component is sealed in a separate package.

[0120] The present invention also includes a method for measuring the concentration of an analyte in an absorbent article. A vacuum fluid is collected and delivered via a delivery layer to at least one colorimetric analyte sensing element. A countdown for a predetermined time period begins based on the presence of the body fluid at the at least one colorimetric analyte sensing element. After the predetermined time period, optical data associated with the colorimetric analyte sensing element is collected using at least one spectrophotometer. The optical data is transmitted 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.

[0121] The predetermined time period after the body fluid comes into 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 more. The predetermined time period after the body fluid comes into contact with the colorimetric analyte sensing element can be a predetermined time range, for example, about 15 seconds to about 360 seconds, or about 30 seconds to about 240 seconds, or about 120 seconds to about 180 seconds, or about 240 seconds to about 360 seconds.

[0122] The analytes measured by the system can be glucose, ketones, bilirubin, blood, pH, protein, urobilinogen, nitrite, leukocytes, and / or creatinine, etc.

[0123] Analytes present in bodily fluids may potentially carry evidence of metabolic system problems. People both inside and outside healthcare facilities wish to track and analyze changes in the concentration of analytes in bodily fluids over time. These changes can be used to predict the risk of future disease symptoms. Therefore, the system described in this invention allows for methods used to predict the risk of future disease symptoms.

[0124] Vacuum fluid is collected as described above and transported via a delivery layer to at least one colorimetric analyte sensing element. The presence of the body fluid at the at least one colorimetric analyte sensing element initiates a countdown for a predetermined time period. After the predetermined time period, optical data related to the colorimetric analyte sensing element is collected using at least one spectrophotometer. The optical data is transmitted 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. A threshold analyte concentration indicating the risk of developing future disease symptoms is compared with the concentration of the at least one analyte, and this can be recorded over time. Therefore, the risk of developing future disease symptoms can be monitored over time.

[0125] The system can be arranged, configured, and programmed with multiple photodetectors 124 and multiple colorimetric analyte sensing elements 30 to determine the concentrations of multiple analytes in the body fluid.

[0126] Non-invasive measurement of analyte concentrations in bodily fluids is also ideally suited for epidemiological studies to rapidly identify prevalent problems in specific regions or populations. Analyte concentration measurements from System 10 can be collected over long periods across a broad population. The collected data can be studied to determine the relationship between various analyte levels and disease states, or in combination with other physiological parameters such as blood pressure, blood oxygen levels, and pulse rate, or with vital statistics such as age, sex, weight, and nationality, to create predictive models of future disease states as functions of preserved parameters.

[0127] The aforementioned method can employ a system deployed in or combined with absorbent articles, such as diapers or pads, or these articles can come into direct contact with bodily fluids without the use of absorbent articles. For example, system 500 can be attached to the body-facing surface of a diaper. Figures 18 to 20The system 500 can come into direct contact with bodily fluids. It can be immersed in bodily fluids, which are initially collected in a sample container by the gripping system 500 on the proximal end 620 of the durable component 600 via the finger grip portion 660. The system 500 can be powered by an activation button 650 on the proximal end 620 of the durable component 600 before or after the distal end 630 is placed into the sample container. Alternatively, the indicator component of the system 500 can be placed in a flow of bodily fluids such as urine as fluid is expelled from the body. In these applications, the durable component 600 is a handheld analyzer.

[0128] Example

[0129] Example 1: Demonstration of the stability of reflectance values ​​with respect to time in a colorimetric analysis material sensing element .

[0130] To test the change in reflectance values ​​over time, reflectance values ​​were measured using a prototype spectrophotometer on a series of prototype colorimetric analyte sensing elements exposed to a glucose solution at room temperature.

[0131] Build a prototype spectrophotometer using the following components:

[0132] • Light source 122: RGB LEDs with wavelengths of 624nm, 525nm, and 468nm from INOLUX (Santa Clara, CA). Part number: IN-S66TATRGB.

[0133] • Photodetector 124: Integrated circuit (IC) color light-to-digital converter with infrared (IR) filter. The IC provides digital values ​​for red, green, blue (RGB) and transparent light sensing. The IR blocking filter minimizes the IR spectral components, allowing for accurate color measurements. Part number TCS34725, available from ams AG (Premstaetten, Austria).

[0134] The prototype colorimetric analyte sensing element 30 is a porous polysulfone membrane from PortaScience (Moorsetown, NJ). The membrane is bonded with the following mixture:

[0135] • Glucose oxidase: 16.3% w / w

[0136] Horseradish peroxidase: 0.6% w / w

[0137] Potassium iodide: 7% w / w

[0138] • 60.7% w / w buffer, and

[0139] • 16.7% W / W non-reactive component.

[0140] The tests were performed using an artificial urine solution with a glucose concentration of 25 mg / dL. All tests were performed at room temperature.

[0141] Three wavelengths (red, green, and blue) of light were scanned on the dried colorimetric analyte sensing element to establish a baseline color for the element. The colorimetric analyte sensing element was then impregnated with a synthetic urine solution. The reflectance at the three optical channels (red, green, and blue) was measured every 30 seconds and recorded.

[0142] Table 1.1 shows the reflectance of the immersion colorimetric analyzer sensing element at each wavelength at each time point.

[0143] Table 1.1: Colorimetric analyte sensing elements impregnated in artificial urine solutions containing 25 mg / dL glucose Reflectance measurement results in the three optical channels .

[0144]

[0145] This shows that the reflectivity of light at each test wavelength decreases over time.

[0146] Next, the relative change of the trace is calculated using the following equation:

[0147] Relative change (t2) = 100 * [reflectivity (t1) - reflectivity (t2)] / reflectivity (t0),

[0148] in:

[0149] Reflectance (t1) and reflectance (t2) are the reflectance measurements at time 1 and time 2, respectively.

[0150] Reflectance (t0) is the reflection measurement result of the sensing element of the dried colorimetric analyte.

[0151] The unit for relative change is percentage (%).

[0152] For example, using the reflectance measurements from the green channel in Table 1.1, the relative change at 60 seconds is calculated as follows:

[0153] Relative change (t) 60 ) = 100 * [1885 - 1736] / 2422 = 6.15%

[0154] Table 1.2 shows the relative changes in reflectance measurements from the green channel of the colorimetric analyzer sensing element at each time point.

[0155] Table 1.2: Relative Changes in Green Channel Reflectance Measurement Results with Relative to Time .

[0156]

[0157] The table shows that the last three values ​​of relative change converge. Therefore, in this embodiment, data acquired 150 seconds after the colorimetric analyte sensing element is immersed in the glucose solution can be used in the algorithm to assess glucose concentration. Alternatively, in glucose testing, the algorithm can use data acquired between 120 and 180 seconds after the colorimetric analyte sensing element is immersed in the glucose solution.

[0158] In other implementations, the convergence value of the relative change can be used to indicate the appropriate time to record data. Thus, for example, when the relative change decreases to below 2% or 1.5%, the algorithm can select that point in time as the time to record data.

[0159] Of course, limitations of this test compared to real-world conditions include the temperature of the solution and the ratio of real urine to the colorimetric analyte sensing element in the system. However, this qualitative embodiment can reflect a real process. Sufficient testing under real-world conditions is necessary.

[0160] Example 2: Stabilization of reflectance values ​​with respect to time in a colorimetric analysis analyte sensing element with a moisture sensor Proof of Sex .

[0161] As described above, conductive strips 108a and 108b serve as moisture sensors in system 10 and are arranged and configured to transmit the presence of moisture in the colorimetric analyte sensing element 30 to a computing system disposed in the durable component 100. In this embodiment, reflectance measurements are performed on a series of prototype colorimetric analyte sensing elements exposed to a glucose solution at room temperature using a prototype spectrophotometer, wherein the moisture sensor is used to initiate the testing of the analyte in the colorimetric sensor.

[0162] The prototype spectrophotometer and prototype colorimetric analyte sensing element were the same as those used in Example 1, and were identical to those used with the artificial urine solution (25 mg / dL glucose concentration). As in Example 1, all tests were performed at room temperature.

[0163] The test is executed as follows:

[0164] 1. Apply 1.5 mL of artificial urine at the 3 o'clock position on the periphery of the prototype colorimetric analyzer sensing element.

[0165] 2. The capacitor moisture sensor indicates that the sensor is fully wetted in less than 20 seconds.

[0166] 3. Place the prototype colorimetric analyzer sensing element squarely on the prototype spectrophotometer and perform reflectance measurements every 60 seconds at the three optical channels (red, green, and blue). Record the reflectance.

[0167] Table 2.1 shows the reflectance of the immersion colorimetric analyzer sensing element at each wavelength at each time point.

[0168] Table 2.1: Colorimetric analyte sensing elements impregnated in artificial urine solutions containing 25 mg / dL glucose Reflectance measurement results in the three optical channels .

[0169]

[0170] The relative changes in the reflection measurements of the green channel were calculated as shown in Example 1. Table 2.2 shows the relative changes in the reflection measurements at each time point.

[0171] Table 2.2: Relative Changes in Green Channel Reflectance Measurement Results with Relative to Time .

[0172]

[0173] The table shows that the last three values ​​of relative change indicate the data transformation. Therefore, in this embodiment, data acquired 240 seconds or 300 seconds after the colorimetric analyte sensing element is immersed in the glucose solution can be well used in the algorithm to assess glucose concentration. Alternatively, in glucose testing, the algorithm can use data acquired between 240 seconds and 360 seconds after the colorimetric analyte sensing element is immersed in the glucose solution.

[0174] The above description, embodiments, and examples are provided to aid in the completeness and non-limiting understanding of the invention disclosed herein. Since many variations and embodiments of the invention can be made without departing from its spirit and scope, the invention is defined by the following appended claims.

Claims

1. A disposable indicator component for use with a handheld analyzer, the disposable indicator component comprising: a) First flexible mesh layer; b) A fluid delivery layer, wherein the fluid delivery layer is adjacent to the first flexible mesh layer; as well as c) The fluid is impermeable to the membrane surrounding the indicator area adjacent to the fluid delivery layer; in: I) The first flexible mesh layer, the fluid delivery layer, and the fluid-impermeable membrane are stacked and fixed together in sequence; II) The indicator area includes at least two colorimetric analyte sensing elements; III) The fluid-impermeable membrane has discrete bags disposed thereon, the discrete bags being configured to accommodate each of the at least two colorimetric analyte sensing elements, and each bag having a single orifice in fluid communication with the fluid delivery layer; IV) The fluid transport layer is arranged and configured to inhibit the transport of fluid between orifices in the fluid-impermeable membrane.

2. The disposable indicator component according to claim 1, wherein the disposable indicator component comprises a diaper.

3. The disposable indicator component of claim 1, wherein the disposable indicator component is arranged and configured for releasable attachment to a diaper.

4. The disposable indicator component according to claim 1, further comprising: d) Top plate, which is adjacent to the first flexible mesh layer; as well as e) Keep the plate. The first flexible mesh layer, the fluid delivery layer, and the fluid-impermeable membrane are fixed between the top plate and the retaining plate, and the disposable indicator component also includes a coupler for releasably attaching the disposable indicator component to the housing of the handheld analyzer.

5. The disposable indicator component according to claim 4, wherein, The top plate and the retaining plate are arranged and configured to provide a predetermined spacing to accommodate an indicator component layer with a predetermined fluid delivery capacity into the indicator area.

6. The disposable indicator component according to claim 1, wherein the disposable indicator component is enclosed in a separate package.

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