A non-invasive device and associated method for measuring concentration of bilirubin
The non-invasive bilirubin measurement device addresses inaccuracies and costs by using an optical detection unit with beam splitter and sensor for accurate bilirubin assessment, enhancing neonatal care.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- MEDBLUE INNOVATIONS PVT LTD
- Filing Date
- 2025-11-27
- Publication Date
- 2026-07-02
AI Technical Summary
Existing non-invasive bilirubin measurement techniques are inaccurate due to skin interference factors and costly, posing a barrier to widespread use, and invasive methods cause trauma and infection risks.
A non-invasive device with an optical detection unit that uses a contact tip, beam splitter, concentrator, and optical sensor to measure bilirubin concentration via statistical regression analysis, accounting for skin factors and providing accurate readings.
The device offers accurate, cost-effective bilirubin measurement, reducing trauma and infection risks, and enabling timely neonatal jaundice diagnosis and treatment.
Smart Images
Figure IN2025051952_02072026_PF_FP_ABST
Abstract
Description
[0001] A NON-INVASIVE DEVICE AND ASSOCIATED METHOD FOR MEASURING CONCENTRATION OF BILIRUBIN FIELD OF THE INVENTION
[0002] [1] The present disclosure generally relates to measurement of substances within body tissues or fluids present in a body of a person. More particularly, the present disclosure relates to a non-invasive device and an associated method for measuring a concentration of bilirubin present in a body of a person.
[0003] BACKGROUND
[0004] [2] Measurement of substances within body tissues or fluids, such as blood, is commonly performed for use in diagnosis or in the monitoring of certain medical conditions. In many cases, such as in the measurement of bilirubin in blood serum, a blood sample is taken for analysis. This is commonly done in the assessment of jaundice in new-born babies by taking a blood sample from the baby's heel.
[0005] [3] However, this procedure can traumatize the baby, lead to infection(s), (particularly if repeated samples need to be taken to monitor treatment), and does not provide a reliable measurement at high concentrations of bilirubin.
[0006] [4] A number of non-invasive optical techniques have been proposed for measurement of substances such as bilirubin. These involve illuminating a subject skin with light having one or more wavelengths, detecting the light reflected from the skin, or in some cases transmitted through the body tissues, e.g. through a finger, and analyzing the results to measure a spectral characteristic of the reflected or transmitted light caused by the substance to be measured. Such measurements are, however, subject to interference by a number of factors including dermal thickness and melanin content of the skin, hemoglobin, ceramides, sebum, and hydration of the skin, resulting in inaccurate measurements. Further, transcutaneous bilirubinmeasurement can be affected by a variety of factors such as phototherapy and exposure to sunlight. Furthermore, existing devices that can be used to assess the level of transcutaneous bilirubin non-invasively are expensive. The high cost of such devices, and associated disposables presents a barrier for widespread use.
[0007] [5] Accordingly, there is a need for a device and method that can overcome one or more problems discussed herein.
[0008] SUMMARY
[0009] [6] This summary is provided to introduce a selection of concepts, in a simplified format, that is further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention.
[0010] [7] In accordance with an embodiment of the present disclosure, a non-invasive device for measuring a concentration of bilirubin present in a body of a person is disclosed. The non-invasive device includes a contact tip member configured to contact a skin surface of the body of the person, an optical beam concentrator disposed at least partially within the contact tip member, an optical detection unit coupled to the contact tip member. The optical detection unit includes an optical housing, a light source disposed within the optical housing and configured to emit white light, a plurality of optical members having a beam splitter, a beam splitter grating, a concentrating lens, and a wave amplification channel member, disposed within the optical housing. The optical detection unit further includes an optical sensor having an optical filter and a photodiode layer disposed on the optical filter, disposed within the optical housing. The optical detection unit further includes a casing coupled to the optical detection unit. The non-invasive device further includes a processing unit disposed within the casing. The processing unit is configured to determine a value indicative of the concentration of bilirubin basedon an output from the optical sensor, using a predetermined equation obtained from a statistical based regression analysis technique.
[0011] [8] In accordance with an embodiment of the present disclosure, a method for measuring a concentration of bilirubin present in a body of a person, using a non-invasive device is disclosed. The method includes contacting a contact tip member to a skin surface of the body of the person. The method further includes emitting white light from a light source disposed within an optical housing of an optical detection unit. Furthermore, the method includes splitting, by a beam splitter, the white light to generate a plurality of light beams. Additionally, the method includes directing, via an optical beam concentrator disposed at least partially within the contact tip member, the plurality of light beams to the skin surface of the body of the person. Further, the method includes directing, via the optical beam concentrator and the beam splitter, a plurality of reflected light beams to a beam splitter grating. Furthermore, the method includes splitting, via the beam splitter grating, the plurality of reflected light beams, to generate a plurality of split light beams. Each split light beam corresponds to a corresponding light wavelength of a light spectrum. The method additionally includes directing, via a concentrating lens and a wave amplification channel member, the plurality of split light beams to an optical sensor having an optical filter and a photodiode layer disposed on the optical filter. The beam splitter, the beam splitter grating, the concentrating lens, the wave amplification channel member, and the optical sensor are disposed within the optical housing. The method further includes directing an output from the optical sensor to a processing unit disposed within a casing. Additionally, the method includes determining, by the processing unit, a value indicative of the concentration of bilirubin based on the output from the optical sensor, using a predetermined equation obtained from a statistical based regression analysis technique.
[0012] [9] To further clarify the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the inventionMB01
[0013] and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.
[0014] BRIEF DESCRIPTION OF THE DRAWINGS
[0015]
[0010] These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:
[0016]
[0011] Figure 1 is a non-invasive device for measuring a concentration of bilirubin present in a body of a person in accordance with an exemplary embodiment of the present disclosure;
[0017]
[0012] Figure 2 is a perspective view of the contact tip member and the optical detection unit in accordance with the embodiment of figure 1 of the present disclosure;
[0018]
[0013] Figure 3 is a diagrammatical representation of the optical sensor in accordance with the embodiment of figure 2 of the present disclosure;
[0019]
[0014] Figure 4 is a block diagram of a processing unit disposed in the casing of the non-invasive device in accordance with embodiments of figures 1, 2, and 3 of the present disclosure;
[0020]
[0015] Figure 5 is a perspective view of the non-invasive device in accordance with an exemplary embodiment of the present disclosure;
[0021]
[0016] Figure 6 is a flow chart illustrating a method for measuring a concentration of bilirubin present in a body of a person, using the non-invasive device in accordance with the embodiments of figures 1-5 of the present disclosure;
[0022]
[0017] Figure 7 is a diagrammatical representation of the optical filter in accordance with the exemplary embodiment of the present disclosure;MB01
[0023]
[0018] Figure 8 is a table representative of an embodiment of ten filter channels and a clear channel of the optical filter in accordance with the embodiment of figure 7;
[0024]
[0019] Figure 9 is a table indicative of variables and regression coefficients of the ten filter channels and the clear channel of the optical filter in accordance with one embodiment of the present disclosure; and
[0025]
[0020] Figure 10 is a table indicative of the variables and the regression coefficients of the ten filter channels and the clear channel of the optical filter in accordance with another embodiment of the present disclosure.
[0026]
[0021] Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help to improve understanding of aspects of the present invention. Furthermore, in terms of the construction of vehicle, one or more components of the vehicle may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.
[0027] DETAILED DESCRIPTION OF FIGURES
[0028]
[0022] For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the various embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the present disclosure as illustrated therein being contemplated as would normally occur to one skilled in the art to which the present disclosure relates.MB01
[0029]
[0023] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are explanatory of the present disclosure and are not intended to be restrictive thereof.
[0030]
[0024] Whether or not a certain feature or element was limited to being used only once, it may still be referred to as “one or more features” or “one or more elements” or “at least one feature” or “at least one element.” Furthermore, the use of the terms “one or more” or “at least one” feature or element do not preclude there being none of that feature or element, unless otherwise specified by limiting language including, but not limited to, “there needs to be one or more...” or “one or more elements is required.”
[0031]
[0025] Reference is made herein to some “embodiments.” It should be understood that an embodiment is an example of a possible implementation of any features and / or elements of the present disclosure. Some embodiments have been described for the purpose of explaining one or more of the potential ways in which the specific features and / or elements of the proposed disclosure fulfil the requirements of uniqueness, utility, and non-obviousness.
[0032]
[0026] Use of the phrases and / or terms including, but not limited to, “a first embodiment,” “a further embodiment,” “an alternate embodiment,” “one embodiment,” “an embodiment,” “multiple embodiments,” “some embodiments,” “other embodiments,” “further embodiment”, “furthermore embodiment”, “additional embodiment” or other variants thereof do not necessarily refer to the same embodiments. Unless otherwise specified, one or more particular features and / or elements described in connection with one or more embodiments may be found in one embodiment, or may be found in more than one embodiment, or may be found in all embodiments, or may be found in no embodiments. Although one or more features and / or elements may be described herein in the context of only a single embodiment, or in the context of more than one embodiment, or in the context of all embodiments, the features and / or elements may instead be provided separately or in any appropriate combination or not at all. Conversely, any featuresMB01
[0033] and / or elements described in the context of separate embodiments may alternatively be realized as existing together in the context of a single embodiment.
[0034]
[0027] Any particular and all details set forth herein are used in the context of some embodiments and therefore should not necessarily be taken as limiting factors to the proposed disclosure.
[0035]
[0028] The terms “comprises”, “comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by “comprises... a” does not, without more constraints, preclude the existence of other devices or other sub- systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.
[0036]
[0029] Embodiments of the present disclosure will be described below in detail with reference to the accompanying drawings.
[0037]
[0030] Figure 1 is a non-invasive device (10) for measuring a concentration of bilirubin present in a body of a person, in accordance with an exemplary embodiment of the present disclosure. In the illustrated embodiment, the non-invasive device (10) includes a contact tip member (12), an optical detection unit (14), and a casing (16). The contact tip member (12) is configured to contact a skin surface of the body of the person. The optical detection unit (14) is coupled to the contact tip member (12). The casing (16) is coupled to the optical detection unit (14). A healthcare professional may hold the non-invasive device (10) at locations including but not limited to a forehead, a hand, and a foot of the person to measure the concentration of bilirubin at different locations of the person.
[0038]
[0031] Figure 2 is a perspective view of the contact tip member (12) and the optical detection unit (14) in accordance with the embodiment of figure 1 of the present disclosure. In the illustrated embodiment, the non-invasive device (10) furtherMB01
[0039] includes an optical beam concentrator (18) disposed at least partially within the contact tip member (12). The contact tip member (12) is made of a material including but not limited to at least one of polymethyl methacrylate, glass, polycarbonate, and polytetrafluoroethylene. In one embodiment, the material of the contact tip member (12) may further include an additive such as but not limited to acrylonitrile butadiene styrene. In another embodiment, the contact tip member (12) may be a flexible silicon conical shaped contact tip member used to access multiple body areas while taking readings / measurements. Th contact tip member (12) may also be used as a holder to precisely keep the non- invasive device (10) at the test area / location.
[0040]
[0032] The optical detection unit (14) includes a light source (20) disposed within an optical housing (22) [shown in figure 1] and configured to emit white light. The optical detection unit (14) further includes a plurality of optical members comprising a beam splitter (24), a concentrating lens (26), a beam splitter grating (28), and a wave amplification channel member (30), disposed within the optical housing (22).
[0041]
[0033] The beam splitter (24) is a rotating or a non-rotating beam separator made of optical filter or isolated optical channels or paths. The beam splitter (24) is configured to receive white light and transmit separated light beams of different wave lengths. The beam concentrator (18) is configured to focus the separated light beams to the skin surface via the contact tip member (12). The beam splitter grating (28) is configured to receive a plurality of reflected light beams from the skin surface and generate a plurality of split light beams. Each split light beam corresponds to a corresponding light wavelength of a light spectrum. Specifically, the split light beams include light beams of seven different colors including violet, indigo, blue, green, yellow, orange, and red colors. The concentrating lens (26) is configured to focus the plurality of split light beams. The wave amplification channel member (30) is configured to amplify the optical power of the plurality of split light beams.MB01
[0042]
[0034] The optical detection unit (14) further includes an optical sensor (32) disposed within the optical housing (22). The optical sensor (32) includes an optical filter (34) and a photodiode layer (36) disposed on the optical filter (34). The optical sensor (32) is configured to receive the amplified plurality of split light beams and generate an output (i.e., electrical output) corresponding to the received amplified plurality of split light beams.
[0043]
[0035] Figure 3 is a diagrammatical representation of the optical sensor (32) in accordance with the embodiment of figure 2 of the present disclosure. In the illustrated embodiment, the optical sensor (32) includes the optical filter (34) and a photodiode layer (36) disposed on the optical filter (34). The optical filter (34) includes ten filter channels and a clear channel. Each of the ten filter channels corresponds to a corresponding light wavelength of the light spectrum. Specifically, the ten filter channels are color filter channels made in such a way that each filter channel exhibits specific surface tension that gives it the property to direct the corresponding light beam incident on it to the photodiode layer (36). In one embodiment, two of the ten filter channels correspond to the infra-red light and the remaining filter channels correspond to the frequency-based light emission. The optical filter (34) is made of a material including but not limited to at least one of tantalum pentoxide and silver nitride. The optical filter (34) is configured to generate constructive and destructive interference of respective wavelengths of the plurality of split light beams. The photodiode layer (36) includes an array of photodiodes (38) and a layer of nano optic material (40). The layer of nano optic material (40) is made of a material having high sensitivity for the photons.
[0044]
[0036] The optical sensor (32) further includes a micro-glass lens (42), an anti-reflective coating (44), and an epoxy microlens layer (46). Specifically, the optical filter (34) is disposed on the micro-glass lens (42). The micro-glass lens (42) is disposed on the anti-reflective coating (44). Further, the anti-reflective coating (44) is disposed on the epoxy microlens layer (46).MB01
[0045]
[0037] Figure 4 is a block diagram of a processing unit (48) disposed in the casing (16) of the non-invasive device (10) in accordance with embodiments of figures 1, 2, and 3 of the present disclosure. The processing unit (48) is configured to determine a value indicative of the concentration of bilirubin based on an output from the optical sensor (32), using a predetermined equation obtained from a statistical based regression analysis technique.
[0046]
[0038] Further, in the illustrated embodiment, the non-invasive device (10) further includes a memory unit (50) disposed in the casing (16) and coupled to the processing unit (48). The memory unit (50) includes a flash memory (52) and Electrically Erasable Programmable Read-only Memory (EPROM) (54). In some embodiments, the processing unit (48) is used to control at least one function of the non-invasive device (10). In certain embodiments, the processing unit (48) may include more than one processor co-operatively working with each other for performing intended functionalities. The processing unit (48) is further configured to store and retrieve contents into and from the memory unit (50).
[0047]
[0039] In one embodiment, the processing unit (48) includes at least one of a general-purpose computer, a graphics processing unit (GPU), a digital signal processor, and a controller. In some embodiments, the processing unit (48) may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and / or any device that manipulates signals based on operational instructions. Among other capabilities, the at least one processor is configured to fetch and execute computer-readable instructions stored in the memory unit (50). In other embodiments, the processing unit (48) includes a customized processor element such as, but not limited to, an application-specific integrated circuit (ASIC) and a field-programmable gate array (FPGA). In some embodiments, the processing unit (48) may be communicatively coupled with at least one of a keyboard, a mouse, and any other input device and configured to receive commands and / or parameters from an operator via a console.MB01
[0048]
[0040] The memory unit (50) includes a flash memory (52) and Electrically Erasable Programmable Read-only Memory (EPROM) (54). In one embodiment, the memory unit (50) is a random-access memory (RAM), a read only memory (ROM), or any other type of computer readable memory accessible by the processing unit (48). In some embodiments, the memory unit (50) may include, for example, volatile memory such as static random-access memory (SRAM) and / or dynamic random-access memory (DRAM) and / or non-volatile memory such as read only memory (ROM), hard disks, optical disks, and / or magnetic tapes. Also, in certain embodiments, the memory unit (50) may be a non-transitory computer readable medium encoded with a program having a plurality of instructions to instruct the processing unit (48) to perform a sequence of steps to operate the non-invasive device (10).
[0049]
[0041] In certain embodiments, the non-invasive device (10) may include an input and output (VO) unit (56) provided to an outer surface of the casing (16) and having a variety of client application and hardware interfaces, for example, a web interface, a graphical user interface, and the like. The input and output unit (56) includes a display unit (58), input buttons (60), and a touch screen (62) that allows the processing unit (48) to interact with a customer directly or through customer devices. Further, the input and output unit (56) may enable the processing unit (48) to communicate with other computing devices such as web servers and external data servers (not shown). The input and output unit (56) is also communicatively coupled to a communication unit (64) disposed in the casing (16) and having Bluetooth (66), a Universal Serial Bus (USB) (68), and Wi-Fi (70). The input and output unit (56) interface may facilitate multiple communications within a wide variety of networks and protocol types, including wired networks such as Local Area Network, cable, etc., and wireless networks such as Wireless Local Area Network, cellular, satellite, etc. The input and output unit (56) may include one or more ports for connecting a plurality of devices to each other and / or to another server. Furthermore, the non-invasive device (10) includes a power source unit (72)MB01
[0050] including a battery disposed in the casing (16). The power source unit (72) is configured to supply electric power for operating the non-invasive device (10).
[0051]
[0042] The processing unit (48) is configured to determine a value indicative of the concentration of bilirubin based on an output from the optical sensor (32), using a predetermined equation obtained from a statistical based regression analysis technique.
[0052]
[0043] The predetermined equation is represented by:
[0053] Y =X i B i +X2B 2+X3B 3+X4B 4+X5B 5+X6 B 6+X7B 7+Xs .B 8+X9B 9+X 1 oB 10+X 11 Bn+E, (1)
[0054] wherein Y represents the value indicative of the concentration of bilirubin, Xi to .X10 are representative of variables of ten light beams of different colors and wavelengths corresponding to the ten filter channels respectively of the optical filter (34) used for different analytes present in the body of the person, Bi to Bio are representative of regression coefficients of ten light beams of different colors and wavelengths for the ten filter channels respectively of the optical filter (34), Xu is a representative of a variable of clear light beam corresponding to a clear channel of the optical filter, and Bn is representative of regression coefficient of clear light beam corresponding to the clear channel of the optical filter (34) ( Xu and Bn act as the frequency adjusters for the light source (20), wherein at some instances, the usage of light source (20) may change intensity and frequency over time, and hence the last filter channel functions as the counter balance mechanism for such instances), and E is indicative of matrix of residuals (the difference between the actual and predicted values). It should be noted herein that regression coefficients are constant values obtained by testing of the optical sensor (32) with reference to standard optical sensor for an estimation of the particular analyte (i.e. bilirubin). The processing unit (48) further includes an analog-to-digital converter (49) for converting the analog signals from the optical sensor (32) to corresponding digital values (i.e. values of Xi to .Xu).MB01
[0055]
[0044] Figure 5 is a perspective view of the non-invasive device (10) in accordance with an exemplary embodiment of the present disclosure. As discussed herein, the includes the contact tip member (12), the optical detection unit (14), and the casing (16). The optical detection unit (14) is coupled to the contact tip member (12). The casing (16) is coupled to the optical detection unit (14).
[0056]
[0045] In the illustrated embodiment, the non-invasive device (10) further includes a slidable button (74), a test button (76), and visual indicator (78) provided to the casing (16). The slidable button (74) is configured to be slidable for switching ON or OFF the non-invasive device (10). The test button (76) is configured to be pushed to record the readings. Further, the test button (76) is configured to be pushed for a longer duration to retrieve previous records. Furthermore, the test button (76) is configured to be pushed twice to synchronize the data with a predetermined application.
[0057]
[0046] In the illustrated embodiment, the visual indicator (78) is coupled to the processing unit (48). Further, the visual indicator (78) is configured to provide at least one of a first visual indication signal indicative of an action required based on an output of the processing unit (48) and a second visual indication signal indicative of charge status of the power source unit (72). In one embodiment, the first visual indication signal may show but not limited to a green light indicative of normal bilirubin value, a yellow light indicative that the person tested should be put on follow-up, and red light indicative that person being tested needs attention, during a testing process using the non-invasive device (10). Further, the second visual indication signal may show but not limited to green light indicative of battery being fully charged, yellow light indicative that charging is going “ON”, blinking red light indicative of low battery charge condition, and blue light indicative that data are being synchronized.
[0058]
[0047] Figure 6 is a flow chart (80) illustrating a method for measuring a concentration of bilirubin present in a body of a person, using the non-invasive device (10) in accordance with the embodiments of figures 1-5 of the presentMB01
[0059] disclosure. The method (80) includes contacting a contact tip member (12) to a skin surface of the body of the person as represented by step (82). The method (80) further includes emitting white light from a light source (20) disposed within an optical housing (22) of the optical detection unit (14) as represented by step (84). Furthermore, the method (80) includes splitting, by the beam splitter (24), the white light, to generate a plurality of light beams of different wave lengths as represented by step (86). Additionally, the method (80) includes directing, via the optical beam concentrator (18) disposed at least partially within the contact tip member (12), the plurality of light beams to the skin surface of the body of the person as represented by step (88). The beam concentrator (18) focuses the plurality of separated light beams to the skin surface via the contact tip member (12).
[0060]
[0048] Further, the method (80) includes directing a plurality of reflected light beams to the beam splitter grating (28) as represented by step (90). Specifically, the plurality of reflected light beams is generated after absorption of a portion of the plurality of light beams by the plurality of analytes present in the body of the person. Furthermore, the method (80) includes splitting, via the beam splitter grating (28), the plurality of reflected light beams, to generate a plurality of split light beams as represented by step (92). It should be noted herein that each split light beam corresponds to a corresponding light wavelength of the light spectrum. Specifically, the split light beams include light beams of seven different colors including violet, indigo, blue, green, yellow, orange, and red colors. Furthermore, the method (80) includes directing, via the concentrating lens (26) and the wave amplification channel member (30), the plurality of split light beams to the optical sensor (32) having the optical filter (34) and the photodiode layer (36) disposed on the optical filter (34) as represented by step (94). The concentrating lens (26) focuses the plurality of split light beams. The wave amplification channel member (30) amplifies the optical power of the plurality of split light beams.
[0061]
[0049] Additionally, the method (80) includes directing an output from the optical sensor (32) to the processing unit (48) disposed within the casing (16) as represented by step (96). Specifically, the optical sensor (32) receives the amplifiedMB01
[0062] plurality of split light beams and generates an output (i.e., electrical output) corresponding to the received amplified plurality of split light beams. More specifically, the output is generated from the photodiode layer (36) based on constructive and destructive interference of respective wavelengths of the plurality of split light beams. When a peak of one wavelength of light aligns with a peak of another wavelength of light, it leads to constructive interference and makes the intensity of that particular light wavelength higher. Similarly, when a peak of one wavelength of light and trough of another wavelength of light aligns, it leads to destructive interference that leads to filtration of unwanted wavelengths of light. The ten filter channels of the optical filter (34) enable passage of corresponding ten light beams of different colors and wavelengths to the photodiode layer (36). The remaining channel (i.e. eleventh channel) of the optical filter (34) enables passage of clear light beam. Specifically, the sensed wavelengths of light are transmitted to the array of photodiodes (38), the absorption excites the electrons in the semiconductor causing the electrons to jump at a higher energy state. Such jump of electrons leads to charged holes that leads to small current generated by the photodiodes of the photodiode layer (36).
[0063] Further, the method (80) includes determining, by the processing unit (48), a value indicative of the concentration of bilirubin based on the output from the optical sensor (32), using a predetermined equation obtained from a statistical based regression analysis technique as represented by step (98). The predetermined equation is represented by equation (1) mentioned herein. With reference to equation (1) mentioned herein, Y represents the value indicative of the concentration of bilirubin, Xi to .Xio are representative of variables of the ten light beams of different colors and wavelengths corresponding to the ten filter channels respectively of the optical filter (34) used for different analytes present in the body of the person, Bi to Bio are representative of regression coefficients of ten light beams of different colors and wavelengths for the ten filter channels respectively of the optical filter (34), Xu is a representative of a variable of clear light beam corresponding to the clear channel of the optical filter (34), and Bu is representativeMB01
[0064] of regression coefficient of clear light beam corresponding to the clear channel of the optical filter (34). It should be noted herein that regression coefficients are constant values obtained by testing of the optical sensor (32) with reference to standard optical sensor for an estimation of the particular analyte (i.e. bilirubin). It should further be noted herein that variable and regression coefficient corresponding to the clear channel (i.e. Xu and Bn) act as the frequency adjusters for the light source (20) and the optical sensor (32). For example, in some instances, the usage of light source (20) may change intensity and frequency over time, and performance of the optical sensor (32) may vary over time. Hence the last filter channel (i.e. clear channel) functions as the counterbalance mechanism for such instances). E is indicative of matrix of residuals (the difference between the actual and predicted values) or a base value of the bilirubin concentration. The analog-to-digital converter (49) of the processing unit (48) converts the analog signals from the optical sensor (32) to corresponding digital values (i.e. values of Xi to .Xu).
[0065]
[0050] In some embodiments, the method (80) may include providing at least one of a first visual indication signal indicative of an action required, by a visual indicator (78) provided to the casing (16), based on an output of the processing unit, and a second visual indication signal indicative of charge status of the power source unit (72), by the visual indicator (78).
[0066]
[0051] Figure 7 is a diagrammatical representation of the optical filter (34) in accordance with the exemplary embodiment of the present disclosure. As mentioned herein, the optical filter (34) includes ten filter channels and a clear channel. Each of the ten filter channels corresponds to a corresponding light wavelength of the light spectrum. The ten filter channels of the optical filter (34) enable passage of corresponding ten light beams of different colors and wavelengths to the photodiode layer (36). The remaining channel (i.e. eleventh channel) of the optical filter (34) enables passage of clear light beam. Specifically, the ten filter channels defined by curves (100), (102), (104), (106), (108), (110), (112), (114), (116), (118) are color filter channels made in such a way that each filter channel exhibits specific surface tension that gives it the property to direct theMB01
[0067] light incident on it to the photodiode layer (36). In one embodiment, two of the ten filter channels correspond to the infra-red light and the remaining filter channels correspond to the frequency-based light emission. Xi to .Xio are representative of variables of the ten light beams of different colors and wavelengths corresponding to the ten filter channels respectively of the optical filter (34) used for different analytes present in the body of the person, Xu is a representative of a variable of clear light beam corresponding to the clear channel of the optical filter (34).
[0068]
[0052] Figure 8 is a table (120) representative of an embodiment of the ten filter channels and a clear channel of the optical filter (34) in accordance with the embodiment of figure 7. The color and the wavelength values shown in columns (120), (124) of figure 8 are just an embodiment and should not be construed as limiting the scope of the present disclosure.
[0069]
[0053] Figure 9 is a table (126) indicative of the variables and regression coefficients (shown in columns (128), (130)) of the ten filter channels and the clear channel of the optical filter (34) in accordance with one embodiment of the present disclosure. The concentration of bilirubin (Y) is computed in accordance with the equation (1) mentioned herein by:
[0070] Y=13.029942976493945+(388x0.099999)+(1565x-0.023195)
[0071] +(2965x-0.011207)+(2442x0.012175)+(2602x0.002462)+(2701x-0.004397)+(3 514x0.001575)+(3198x-0.000047)+(12418x0.000124)+(1140x-0.003365)+(0), wherein Y is computed as 9.64 g / dL.
[0072]
[0054] Figure 10 is a table (132) indicative of the variables and regression coefficients (shown in columns (134), (136)) of the ten filter channels and the clear channel of the optical filter (34) in accordance with another embodiment of the present disclosure. The concentration of bilirubin (Y) is computed in accordance with the equation (1) mentioned herein by:
[0073] Y=(3.029942976493945+(404x0.099999)+(1619x-0.023195)+(3110x-0.011207 )+(2637x0.012175)+(2774x0.002462)+(2956x-0.004397)+(3773x0.001575)+(34MB01
[0074] 60x-0.000047)+(12218x0.000124)+(1140x-0.003365)+(0), wherein Y is computed as 10.42 g / dL.
[0075]
[0055] In accordance with the embodiments of the present disclosure discussed herein, the exemplary non-invasive device provides a cost-effective non-invasive solution to assess bilirubin in neonates at a transcutaneous level. The objective of the present disclosure is to decrease the trauma associated with the process of drawing the sample, and to decrease the mortality rate of neonatal jaundice by enabling instant diagnosis and appropriate treatment. The cost-effective nature of the non-invasive device enables hospitals to manage neonate’s jaundice conditions, and to integrate treatment seamlessly.
[0076]
[0056] The aspects of the present disclosure use a combination of optical modules within the non-invasive device to split the light into wavelengths at which bilirubin has a distinct absorption peak. The source also emits light at different wavelengths, which enables us to isolate contributions from other analytes present in the dermal layers. The processing unit enables a high level of accuracy for measuring concentration of bilirubin. The detection process is performed through an integrated detector array with multispectral filters, thereby enabling reduction of associated cost. The exemplary non-invasive device is also configured to take into consideration of dermal thickness and melanin levels before measuring the concentration of bilirubin levels and hence is also sensitive to lower and higher ranges of bilirubin level.
[0077]
[0057] In this application, unless specifically stated otherwise, the use of the singular includes the plural and the use of “or” means “and / or.” Furthermore, use of the terms “including” or “having” is not limiting. Any range described herein will be understood to include the endpoints and all values between the endpoints. Features of the disclosed embodiments may be combined, rearranged, omitted, etc., within the scope of the invention to produce additional embodiments. Furthermore, certain features may sometimes be used to advantage without a corresponding use of other features.
Claims
We Claim:
1. A non-invasive device (10) for measuring a concentration of bilirubin present in a body of a person, the non-invasive device (10) comprising: a contact tip member (12) configured to contact a skin surface of the body of the person;an optical beam concentrator (18) disposed at least partially within the contact tip member (12);an optical detection unit (14) coupled to the contact tip member (12), wherein the optical detection unit (12) comprises:an optical housing (22);a light source (20) disposed within the optical housing (22) and configured to emit white light;a plurality of optical members comprising a beam splitter (24), a beam splitter grating (28), a concentrating lens (26), and a wave amplification channel member (30), disposed within the optical housing (22); andan optical sensor (32) comprising an optical filter (34) and a photodiode layer (36) disposed on the optical filter (34), disposed within the optical housing (22);a casing (16) coupled to the optical detection unit (14); anda processing unit (48) disposed within the casing (16), wherein the processing unit (48) is configured to determine a value indicative of the concentration of bilirubin based on an output from the optical sensor (32), using a predetermined equation obtained from a statistical based regression analysis technique.
2. The non-invasive device (10) as claimed in claim 1, wherein the contact tip member (12) is made of a material comprising at least one of polymethyl methacrylate, glass, polycarbonate, and polytetrafluoroethylene, whereinthe material further comprises an additive comprising acrylonitrile butadiene styrene.
3. The non-invasive device (10) as claimed in claim 1, wherein the photodiode layer (36) comprises an array of photodiodes (38) and a layer of nano optic material (40).
4. The non-invasive device (10) as claimed in claim 1, wherein the optical filter (34) comprises ten filter channels and a clear channel, wherein each of the ten filter channels corresponds to a corresponding light wavelength of a light spectrum.
5. The non-invasive device (10) as claimed in claim 4, wherein the optical filter (34) is made of a material comprising at least one of tantalum pentoxide and silver nitride.
6. The non-invasive device (10) as claimed in claim 1, wherein the optical sensor (32) comprises:a micro-glass lens (42), an anti-reflective coating (44), and an epoxy microlens layer (46), wherein:optical filter (34) is disposed on the micro-glass lens (42),the micro-glass lens (42) is disposed on the anti-reflective coating (44), and the anti-reflective coating (44) is disposed on the epoxy microlens layer (46).
7. The non-invasive device (10) as claimed in claim 1, comprising:an input and output unit (56) provided to an outer surface of the casing (16); a power source unit (72) disposed within the casing (16);a memory unit (50) coupled to the processing unit (48); anda communication unit (64) provided to the casing (16).MB018. The non-invasive device (10) as claimed in claim 7, comprising a visual indicator (78) provided to the casing (16), wherein the visual indicator (78) is coupled to the processing unit (48) and configured to provide at least one of:a first visual indication signal indicative of an action required based on an output of the processing unit (48); anda second visual indication signal indicative of charge status of the power source unit (72).
9. The non-invasive device (10) as claimed in claim 7, wherein the predetermined equation is represented by:Y =X i B i +X2B 2+X3B 3+X4B 4+X5B 5+X6 B 6+X7B 7+Xs .B 8+X9B 9+X 1 oB 10+X 11 Bn+E, wherein Y represents the value indicative of the concentration of bilirubin, Xi to .X10 are representative of variables of a plurality of light beams of different colors and wavelengths corresponding to ten filter channels respectively of the optical filter (34) used for different analytes present in the body of the person, Bi to Bio are representative of regression coefficients of the plurality of light beams of different colors and wavelengths corresponding to the ten filter channels respectively of the optical filter (34), Xu is a representative of a variable of clear light beam corresponding to a clear channel of the optical filter (34), and Bn is representative of regression coefficient of clear light beam corresponding to the clear channel of the optical filter (34), and E is indicative of matrix of residuals.
10. A method (80) for measuring a concentration of bilirubin present in a body of a person, using a non-invasive device (10), the method (80) comprising: contacting a contact tip member (12) to a skin surface of the body of the person;emitting white light from a light source (20) disposed within an optical housing (22) of an optical detection unit;MB01splitting, by a beam splitter (24), the white light to generate a plurality of light beams;directing, via an optical beam concentrator (18) disposed at least partially within the contact tip member (12), the plurality of light beams to the skin surface of the body of the person;directing a plurality of reflected light beams to a beam splitter grating (28); splitting, via the beam splitter grating (28), the plurality of reflected light beams, to generate a plurality of split light beams, wherein each split light beam corresponds to a corresponding light wavelength of a light spectrum; directing, via a concentrating lens (26) and a wave amplification channel member (30), the plurality of split light beams to an optical sensor (32) comprising an optical filter (34) and a photodiode layer (36) disposed on the optical filter (34), wherein the beam splitter (24), the beam splitter grating (28), the concentrating lens (26), the wave amplification channel member (30), and the optical sensor (32) are disposed within the optical housing (22);directing an output from the optical sensor (32) to a processing unit (48) disposed within a casing (16); anddetermining, by the processing unit (48), a value indicative of the concentration of bilirubin based on the output from the optical sensor (32), using a predetermined equation obtained from a statistical based regression analysis technique.
11. The method (80) as claimed in claim 10, comprising generating the plurality of reflected light beams after absorption of a portion of the plurality of light beams by a plurality of analytes present in the body of the person.
12. The method (80) as claimed in claim 10, wherein directing the output from the optical sensor (32) to the processing unit (48) comprises generating the output from the photodiode layer (36) based on constructive and destructive interference of respective wavelengths of the plurality of split light beams.MB0113. The method (80) as claimed in claim 10, comprising provide at least one of:a first visual indication signal indicative of an action required, by a visual indicator (78) provided to the casing (16), based on an output of the processing unit (48); anda second visual indication signal indicative of charge status of the power source unit (72), by the visual indicator (78).
14. The method (80) as claimed in claim 10, wherein the predetermined equation is represented by:Y =X i B i +X2B 2+X3B 3+X4B 4+X5B 5+X6 B 6+X7B 7+Xs .B 8+X9B 9+X 1 oB 10+X 11 Bn+E, wherein Y represents the value indicative of the concentration of bilirubin, Xi to .X10 are representative of variables of a plurality of light beams of different colors and wavelengths corresponding to ten filter channels respectively of the optical filter (34) used for different analytes present in the body of the person, Bi to Bio are representative of regression coefficients of the plurality of light beams of different colors and wavelengths corresponding to the ten filter channels respectively of the optical filter (34), Xu is a representative of a variable of clear light beam corresponding to a clear channel of the optical filter (34), and Bn is representative of regression coefficient of clear light beam corresponding to the clear channel of the optical filter (34), and E is indicative of matrix of residuals.