DESC:FIELD OF THE INVENTION
The present invention relates to a field of hemoglobin measurement. More particularly,
the present invention relates to a device for non-invasively detecting, measuring and/or
monitoring hemoglobin concentration in a user’s blood in real-time and a method
thereof.
10 BACKGROUND
Background description includes information that may be useful in understanding the
present invention. It is not an admission that any of the information provided herein is
prior art or relevant to the presently claimed invention, or that any publication
specifically or implicitly referenced is prior art.
15 Hemoglobin is an iron-containing, oxygen-transport metalloprotein present in the red
blood cells of almost all vertebrates as well as the tissues of some invertebrates. It is
responsible for carrying oxygen from the lungs to the rest of the body and returning
carbon dioxide from the body cells to the lungs for exhalation. Concentration of
hemoglobin in the blood is a vital parameter for detecting abnormalities in the human
20 body, especially anemia and polycythemia. Anemia is a condition characterized by a
lower amount of red blood cells or hemoglobin concentration in the blood, resulting in an
impaired ability of the blood to transport oxygen. Hemoglobin measurement is an
essential step as well in determining blood loss and can affect therapeutic decisions
including operative intervention and blood transfusion.
25 The current standard of care for anemia detection includes the clinical pallor test and
the WHO’s color scale. However, the blood based assays are only performed at
equipped laboratories and hospitals, which are often well out of reach of an average
citizen of a developing nation. Further, the noninvasive pallor test is based on the color
of the conjunctiva tissue of the eye, thereby relying on the limited judgment and
30 experience of the healthcare worker for determining anemic condition in the patient.
Invasive techniques, in the current practices, are based on ex-vivo measurement of
hemoglobin concentration in whole blood. Point of care testing methods for anemia
typically involve analysis of blood from the patient by finger-prick sample. Although the
current methods are rapid and inexpensive, they require liquid reagents and may
35 expose healthcare workers to risks of blood-borne infections. Moreover, these methods
require venepuncture and specialized equipment that may introduce delays or be
unavailable in resource-poor settings. Furthermore, they may lead to discomfort and
potential complications for the pregnant, elderly and pediatric patients.
With the development of non-invasive detection and point-of-care testing technologies,
40 non-invasive hemoglobin measurement techniques are continuously emerging.
3
5 A non-patent literature by Liu et al. titled “Development and Validation of a
Photoplethysmography System for Noninvasive Monitoring of Hemoglobin
Concentration” discloses a portable prototype of noninvasive spectrophotometry-based
total hemoglobin (tHb) real-time monitoring system.
Another non-patent literature by Shivakumaraswamy et al. titled “Non-Invasive
10 Hemoglobin Measurement” discloses a method and technique involved in designing a
prototype for the non-invasive measurement of hemoglobin.
Indian patent application no. IN201941041551A titled “Non-invasive Portable Device
For Measuring Hemoglobin And Blood Pressure Using Artificial Intelligence” discloses a
non-invasive portable device for measuring hemoglobin and blood pressure using
15 Artificial Intelligence.
US patent application no. US6615064B1 titled “Non-invasive blood component
analyzer” discloses a non-invasive device and method for analyzing the concentration of
blood components, including oxygen saturation, bilirubin, hemoglobin, oxyhemoglobin,
glucose, hormones and a variety of drugs.
20 US patent application no. US20180116515A1 titled “A non-invasive bio-fluid detector
and portable sensor-transmitter-receiver system” discloses a bio-fluid detector such as
a hemoglobin detector having the capability of receiving, storing and transmitting health
information utilizing a portable transmitter and receiver including electronic PDAs such
as cell phones.
25 However, there are a number of drawbacks and/or shortcomings in the currently similar
technologies providing non-invasive hemoglobin measurement techniques and devices.
None of the current technologies provide a solution for negating optical interferences
(noise signals) from ambient light resulting in false-positive hemoglobin predictions.
Moreover, hemoglobin measurement using different-sized body organs is provided by
30 none of the prior arts. This may lead to non-detection of anemic conditions, especially in
infants because of their small finger sizes. Furthermore, the current techniques provide
limited accuracy and range of hemoglobin measurement. Further, the current
technologies do not account for density of the patient’s blood while calculating
hemoglobin concentration. If the blood is too dense, it may absorb more light than
35 expected, resulting in a lower oxygen saturation reading. Conversely, if the blood is less
dense than normal, it may transmit more light than anticipated, leading to a falsely
higher oxygen saturation reading. Additionally, none of the prior arts disclose remote
monitoring of the hemoglobin concentration data.
Thus, there remains a need to address the shortcomings of the cited prior arts by
40 providing a cost-effective and efficient device for non-invasively measuring hemoglobin
concentration in a person’s blood and a method thereof.
4
5 SUMMARY OF THE INVENTION
This summary is provided to introduce a selection of concepts, in a simplified format,
that are further described in the detailed description of the present invention. This
summary is neither intended to identify key or essential inventive concepts of the
present invention and nor is it intended for determining the scope of the present
10 invention.
An embodiment of the present invention relates to a device for non-invasively detecting,
measuring and/or monitoring hemoglobin concentration in a user’s blood in real-time. In
particular, the device comprises an optically isolated compartment, an optical probe,
one or more detection sensors, one or more optical sources, a processing unit, one or
15 more photodetectors, one or more amplifiers, a power supply unit, a switch, a display
unit and an IoT (Internet of Things) communication module.
In accordance with an embodiment of the present invention, the optically isolated
compartment is configured for minimizing optical interference from ambient light. The
optically isolated compartment comprises the optical probe, the one or more optical
20 sources including a first optical source and a second optical source, and the one or
more photodetectors. In particular, the optical probe is configured for receiving a body
part of the user. The one or more detection sensors are configured inside the optical
probe and with a processing unit for detecting receiving of the body part of the user by
the optical probe. Moreover, the first optical source and the second optical source are
25 configured on one side of the optical probe. The processing, on detecting receiving of
the body part of the user by the optical probe using the one or more detection sensors,
automatically switches ON the first optical source for continuously emitting a first optical
signal for a first predetermined time period while keeping the second optical source
switched OFF. Furthermore, the processing unit automatically switches ON the second
30 optical source, on completing the first predetermined time period, for continuously
emitting a second optical signal for a second predetermined time period while keeping
the first optical source switched OFF. Further, the one or more photodetectors are
configured on other side of the optical probe opposite to the one or more optical sources
for detecting transmitted optical signals including a third optical signal transmitted from
35 the body part of the user based on the first optical signal and a fourth optical signal
transmitted from the body part of the user based on the second optical signal. The one
or more photodetectors process the transmitted optical signals into equivalent current
values. The distance between the one or more optical sources and/or the one or more
photodetectors is kept constant.
40 In accordance with an embodiment of the present invention, the first predetermined time
period and/or the second predetermined time period may be in the range of 10 seconds
to 20 seconds each.
5
5 In accordance with an embodiment of the present invention, the first optical signal may
include a red light in the range of 620 nm to 720 nm wavelength and the second optical
signal may include an infrared light in the range of 800 nm to 1100 nm wavelength.
In accordance with an embodiment of the present invention, the one or more amplifiers
are configured with the one or more photodetectors for processing the equivalent
10 current values into equivalent voltage values.
In accordance with an embodiment of the present invention, the processing unit is
connected with the one or more photodetectors for digitally conditioning, filtering and/or
processing the equivalent voltage values into equivalent digital readings. In particular,
the processing unit determines perfusion index (PI) of the user’s blood using the
15 equivalent digital readings. In case the perfusion index (PI) of the user’s blood is below
a threshold value, the processing unit halts processing operation and transmits a first
digital signal to a display unit for displaying a first digital message. Alternatively, if the
perfusion index (PI) of the user’s blood is equal to or above the threshold value, the
processing unit calculates data relating to hemoglobin concentration in the user’s blood
20 and transmits a second digital signal to the display unit for displaying a second digital
message including the data relating to hemoglobin concentration in the user’s blood.
In accordance with an embodiment of the present invention, the threshold value relating
to the perfusion index (PI) of the user’s blood may be 1.24
In accordance with an embodiment of the present invention, the IoT (Internet of Things)
25 communication module is configured with the processing unit for wirelessly transmitting,
to a cloud server, data relating to hemoglobin concentration in the user’s blood
measured by the device. In particular, the user can remotely access and/or monitor data
relating to hemoglobin concentration in the blood measured by the device through the
cloud server.
30 In accordance with an embodiment of the present invention, the power supply unit is
configured with the processing unit for supplying power to operate the device.
In accordance with an embodiment of the present invention, the switch is configured
with the power supply unit and the processing unit for operating the device.
In accordance with an embodiment of the present invention, the display unit is
35 configured with the processing unit for receiving the first digital signal and displaying the
first digital message and/or receiving the second digital signal and displaying the
second digital message.
6
5 Another embodiment of the present invention relates to a system for non-invasively
detecting, measuring and/or monitoring hemoglobin concentration in a user’s blood in
real-time comprising the device, the cloud server and a data analytics unit.
In accordance with an embodiment of the present invention, the data analytics unit is
configured with the cloud server for analyzing data relating to hemoglobin concentration
10 in the user’s blood measured by the device. In particular, the data analytics unit may
use an artificial intelligence based predictive model for improving accuracy of the device
for measuring hemoglobin concentration in the user’s blood based on one or more
parameters. Moreover, the one or more parameters may include age of the user,
gender of the user, SpO2 level of the user and/or pulse rate of the user.
15 OBJECTIVES OF INVENTION
Primary objective of the present disclosure is to provide a suitable, efficient, and costeffective device for non-invasively detecting, measuring and/or monitoring hemoglobin
concentration in a user’s blood in real-time.
Another objective of the present invention is to provide a point of care and portable
20 device for non-invasively detecting, measuring and/or monitoring hemoglobin
concentration in the user’s blood in real-time, thereby bypassing traditional means of
hemoglobin detection requiring extraction of blood from the user.
Yet another objective of the present invention is to provide a device for non-invasively
measuring hemoglobin concentration in the user’s blood using fingers and/or toes,
25 especially in user’s having amputation, diseased conditions and/or injured or damaged
body parts.
Yet another objective of the present invention is to provide a device for non-invasively
measuring hemoglobin concentration in the user’s blood of users including men,
women, children, infants, pregnant women and/or elderly individuals in the age ranging
30 from 5 years to 85 years.
Yet another objective of the present invention is to provide a device for non-invasively
measuring hemoglobin concentration in the user’s blood having high accuracy and a
short processing time.
Other objects and advantages of the present invention will become apparent from the
35 following description taken in connection with the accompanying drawings, illustrations,
and examples to disclose the aspects of the present invention.
BRIEF DESCRIPTION OF DRAWINGS
7
5 So that the manner in which the above recited features of the present invention is
understood in detail, a more particular description of the invention, briefly summarized
above, may be had by reference to embodiments, some of which are illustrated in the
appended drawings. It is to be noted, however, that the appended drawings illustrate
only typical embodiments of this invention and are therefore not to be considered
10 limiting of its scope, for the invention may admit to other equally effective embodiments.
Fig. 1 is a block diagram illustrating a device (100) for non-invasively detecting,
measuring and/or monitoring hemoglobin concentration in a user’s blood in real-time in
accordance with one or more embodiments of the present invention;
Fig. 2 is a diagonal view illustrating the device (100) for non-invasively detecting,
15 measuring and/or monitoring hemoglobin concentration in a user’s blood in real-time in
accordance with one or more embodiments of the present invention;
Fig. 3 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the user’s blood in comparison with the actual hemoglobin
concentration in the user’s blood in accordance with one or more embodiments of the
20 present invention;
Fig. 4 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the users’ blood in comparison with the actual hemoglobin
concentration of users of different age groups in accordance with one or more
embodiments of the present invention;
25 Fig. 5 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the users’ blood in comparison with the actual hemoglobin
concentration of male and female users in accordance with one or more embodiments
of the present invention;
Fig. 6 is a block diagram illustrating a system (200) for non-invasively detecting,
30 measuring and/or monitoring hemoglobin concentration in a user’s blood in real-time in
accordance with one or more embodiments of the present invention; and
Fig. 7 is a flowchart illustrating a process for non-invasively detecting, measuring and/or
monitoring hemoglobin concentration in the user’s blood in real-time based on the
system (200) in accordance with one or more embodiments of the present invention.
35 ELEMENT LIST
Device – 100
Optically isolated compartment – 105
Optical probe – 110
8
5 One or more detection sensors – 115
One or more optical sources – 120
First optical source - 120A
Second optical source - 120B
One or more photodetectors – 125
10 One or more amplifiers – 130
Processing unit – 135
IoT (Internet of Things) communication module (140) – 140
Power supply unit – 145
Switch – 150
15 Display unit – 155
System – 200
Cloud server – 205
Data analytics unit – 210
The device (100) and the system (200) are illustrated in the accompanying drawings,
20 throughout which like reference letters indicate corresponding parts in the various
figures. It should be noted that the accompanying figure is intended to present
illustrations of exemplary embodiments of the present disclosure. This figure is not
intended to limit the scope of the present disclosure. It should also be noted that the
accompanying figure is not necessarily drawn to scale.
25 DETAILED DESCRIPTION
The present invention relates to a device (100) and a system (200) for non-invasively
detecting, measuring and/or monitoring hemoglobin concentration in a user’s blood in
real-time and a method thereof.
The principles of the present invention and their advantages are best understood by
30 referring to FIGS. 1 to FIGS. 7. In the following detailed description numerous specific
details are set forth in order to provide a thorough understanding of the embodiment of
invention as illustrative or exemplary embodiments of the disclosure, specific
embodiments in which the disclosure may be practiced are described in sufficient detail
to enable those skilled in the art to practice the disclosed embodiments. However, it will
9
5 be obvious to a person skilled in the art that the embodiments of the invention may be
practiced with or without these specific details. In other instances, well known methods,
procedures and components have not been described in detail so as not to
unnecessarily obscure aspects of the embodiments of the invention.
The following detailed description is, therefore, not to be taken in a limiting sense, and
10 the scope of the present disclosure is defined by the appended claims and equivalents
thereof. The terms “comprising,” “including,” “having,” and the like are synonymous and
are used inclusively, in an open-ended fashion, and do not exclude additional elements,
features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense
(and not in its exclusive sense) so that when used, for example, to connect a list of
15 elements, the term “or” means one, some, or all of the elements in the list. References
within the specification to “one embodiment,” “an embodiment,” “embodiments,” or “one
or more embodiments” are intended to indicate that a particular feature, structure, or
characteristic described in connection with the embodiment is included in at least one
embodiment of the present disclosure.
20 Although the terms first, second, etc. may be used herein to describe various elements,
these elements should not be limited by these terms. These terms are generally only
used to distinguish one element from another and do not denote any order, ranking,
quantity, or importance, but rather are used to distinguish one element from another.
Further, the terms "a" and "an" herein do not denote a limitation of quantity, but rather
25 denote the presence of at least one of the referenced items.
Conditional language used herein, such as, among others, "can," "may," "might," "may,"
“e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within
the context as used, is generally intended to convey that certain embodiments include,
while other embodiments do not include, certain features, elements and/or steps.
30 Disjunctive language such as the phrase “at least one of X, Y, Z,” unless specifically
stated otherwise, is otherwise understood with the context as used in general to present
that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y,
and/or Z). Thus, such disjunctive language is not generally intended to, and should not,
imply that certain embodiments require at least one of X, at least one of Y, or at least
35 one of Z to each be present.
The term Photoplethysmography (PPG) refers to a non-invasive optical technique used
for detecting and measuring blood volume changes in peripheral tissues. It is based on
the principle of light absorption by blood. The light-emitting diodes (LEDs) emit light,
usually in the visible or near-infrared spectrum, into the tissue and a photodetector
40 measures the transmitted light intensity. When arterial blood flow increases during each
heartbeat, the amount of light absorbed by the tissue changes. These variations in light
10
5 absorption correspond to changes in blood volume, primarily caused by the pulsatile
arterial blood flow. The detected signal represents the changes in blood volume during
each cardiac cycle.
The term “Moving Average Filter (MAF)” refers to the signal conditioning process
method used to smooth out fluctuations in data over time. The MAF filter computes the
10 average of a specific number of consecutive data points in a sliding window and uses
this average value as the filtered output.
The term “Perfusion Index (PI) refers to the proportion of pulsatile blood flow to static
and non-pulsatile blood flow.
Terms “HemoProbe”, “device” or “apparatus” may be interchangeably used throughout
15 this document.
Any reference made with respect to “accuracy”, “variation”, “deviation” and/or the like
regarding the present invention should be construed in respect of results of the
comparative analysis with the biological tests performed at pathological labs for
invasively determining hemoglobin concentration and obtaining the associated lab
20 results data.
Any reference made with respect to “sensitivity”, “repeatability” and/or the like regarding
the present invention should be construed in respect of the property of the device (100)
in accurately measuring hemoglobin concentration in the user’s blood for consecutive
times.
25 Referring to Figs. 1 and 2 illustrates a device (100) for non-invasively detecting,
measuring and/or monitoring hemoglobin concentration in a user’s blood in real-time. In
particular, the device (100) comprises an optically isolated compartment (105), an
optical probe (110), one or more detection sensors (115), one or more optical sources
(120), a processing unit (135), one or more photodetectors (125), one or more
30 amplifiers (130), a power supply unit (145), a switch (150), a display unit (155) and an
IoT (Internet of Things) communication module (140).
In accordance with an embodiment of the present invention, the optically isolated
compartment (105) is configured for minimizing optical interference from ambient light.
In particular, the optically isolated compartment (105) may be configured for minimizing
35 about 99% optical interference due to ambient light.
In an exemplary embodiment, the optically isolated compartment (105) may be made of
including but not limited to ABS (Acrylonitrile Butadiene Styrene). In particular, the ABS
(Acrylonitrile Butadiene Styrene) material being black in color, creates an ideal
11
5 environment for minimizing optical interference of ambient light with the one or more
photodetectors (125) and the body part of the user.
In an exemplary embodiment of the present invention, the optically isolated
compartment (105) may minimize around 99 % optical interference of ambient light. In
accordance with an embodiment of the present invention, the optical probe (110) is
10 configured for receiving a body part of the user.
In accordance with an embodiment of the present invention, the device (100) may be
configured to measure hemoglobin concentration in the user’s blood using the user’s
body parts including but not limited to a finger and/or a toe.
In accordance with an embodiment of the present invention, the one or more detection
15 sensors (115) are configured inside the optical probe (110) and with the processing unit
(135) to detect receiving of the body part of the user by the optical probe (110). In
particular, the one or more detection sensors (115) are advantageously configured to
measure and/or display hemoglobin concentration in the user’s blood within 45 seconds
to 60 seconds.
20 In an exemplary embodiment, the one or more detection sensors (115) may include but
not limited to a touch sensor, capacitive sensor, proximity sensor, position sensor,
passive infrared sensor and/or the like.
In accordance with an embodiment of the present invention, the one or more optical
sources (120) include a first optical source (120A) and a second optical source (120B),
25 both configured on one side of the optical probe (110). On detecting receiving of the
body part of the user by the optical probe (110) using the one or more detection sensors
(115), the processing unit (135) automatically switches ON the first optical source
(120A) for continuously emitting the first optical signal for the first predetermined time
period while keeping the second optical source (120B) switched OFF. Moreover, the
30 processing unit (135) automatically switches ON the second optical source (120B) on
completing the first predetermined time period for continuously emitting the second
optical signal for the second predetermined time period while keeping the first optical
source (120A) switched OFF. Furthermore, the first optical signal is primarily absorbed
by the deoxygenated blood and the second optical signal is primarily absorbed by the
35 oxygenated blood as hemoglobin has different absorption characteristics depending on
its oxygenation state.
In accordance with an embodiment of the present invention, the first predetermined time
period and/or the second predetermined time period may be in the range of 10 seconds
to 20 seconds each.
12
5 In another embodiment, the first predetermined time period and/or the second
predetermined time period may be of 15 seconds each.
In one embodiment, the first optical signal may include a red light in the range of 620
nm to 720 nm wavelength and the second optical signal may include an infrared light in
the range of 800 nm to 1100 nm wavelength.
10 In another embodiment, the first optical signal may include a red light of 660 nm
wavelength and the second optical signal may include an infrared light of 940 nm
wavelength. Alternatively, the first optical signal may include a red light of 660 nm
wavelength and the second optical signal may include an infrared light of 880 nm
wavelength. Moreover, the first optical source (120A) and/or the second optical source
15 (120B) may include but not limited to an LED (Light Emitting Diode), QD-LEDs
(Quantum dot light-emitting diodes), laser diodes and/or the like.
In an exemplary embodiment, the first optical source (120A) may operate at a voltage of
1.6 V and/or a current of 50 mA. Moreover, the second optical source (120B) may
operate at a voltage of 1.25 V and/or a current of 100 mA.
20 In accordance with an embodiment of the present invention, the one or more
photodetectors (125) are configured on other side of the optical probe (110) opposite to
the one or more optical sources (120). In particular, the one or more photodetectors
(125) are configured for detecting transmitted optical signals including a third optical
signal transmitted from the body part of the user based on the first optical signal and a
25 fourth optical signal transmitted from the body part of the user based on the second
optical signal. Moreover, the one or more photodetectors (125) process the transmitted
optical signals into equivalent current values. Furthermore, the one or more
photodetectors (125) operate in photoconductive mode for linearity and/or low dark
current.
30 In an exemplary example, the one or more photodetectors (125) may include but not
limited to OPT 101 optical detector, TSL235R optical sensor, SFH 213 FA photodiode
and/or BPW34 photodiode. In particular, the one or more photodetectors (125) may
operate on a single supply voltage. Moreover, the responsivity of the one or more
photodetectors (125) may lie in the range of 600 nm to 1000 nm.
35 In another exemplary example, the OPT101 photodetector may be powered from 2.7
volts to 36 volts. Moreover, the OPT101 photodetector may have a quiescent current of
120 microampere. The OPT101 photodetector may have a responsivity of 0.45 A/W at
650 nm and a bandwidth of 14 kHz.
13
5 In accordance with an embodiment of the present invention, the distance between the
one or more optical sources (120) and/or the one or more photodetectors (125) is kept
constant in the range of 15 mm to 25 mm.
In another embodiment, the distance between the one or more optical sources (120)
and/or the one or more photodetectors (125) is 20 mm. In particular, the distance
10 between the one or more optical sources (120) and/or the one or more photodetectors
(125) is kept constant as variations in the optical path length can lead to differences in
the amount of light absorbed by the user’s blood, leading to false-positive values for
hemoglobin concentration.
Moreover, the optical path length error is also minimized by considering ratios of Red
15 LED readings and Infrared LED readings from the PPG graph for calculating
hemoglobin concentration in the user’s blood.
In accordance with an embodiment of the present invention, the one or more amplifiers
(130) are configured with the one or more photodetectors (125) for processing the
equivalent current values into equivalent voltage values. In particular, the one or more
20 amplifiers (130) may include but not limited to a trans-impedance amplifier, a current
amplifier, a power amplifier and/or the like.
In an exemplary example, the one or more photodetectors (125) and the transimpedance amplifier may eliminate leakage current errors, noise pick-up, and stray
capacitance. In particular, the trans-impedance amplifier operates for both single power
25 supply and/or dual power supply. Moreover, the output voltage of the trans-impedance
amplifier rises linearly with light intensity.
In accordance with an embodiment of the present invention, the processing unit (135) is
connected with the one or more photodetectors (125) for digitally conditioning, filtering
and/or processing the equivalent voltage values into equivalent digital readings. In
30 particular, the processing unit (135) processes the equivalent digital readings using a
moving average filter as a part of the signal conditioning process. Moreover, the
processing unit (135) determines perfusion index (PI) of the user’s blood using the
equivalent digital readings.
In accordance with an embodiment of the present invention, the processing unit (135)
35 may be configured for sequentially switching ON the first optical source (120A) and the
second optical source (120B) for recording 50 to 300 digital readings in a time period of
15 seconds.
In one embodiment, if the perfusion index (PI) of the user’s blood is below a threshold
value, the processing unit (135) halts processing operation and transmits a first digital
40 signal to a display unit (155) for displaying a first digital message. Alternatively, if the
14
5 perfusion index (PI) of the user’s blood is equal to or above a threshold value, the
processing unit (135) calculates data relating to hemoglobin concentration in the user’s
blood. Moreover, the processing unit (135) transmits a second digital signal to the
display unit (155) for displaying a second digital message including the data relating to
hemoglobin concentration in the user’s blood.
10 In an embodiment of the present invention, the threshold value relating to the perfusion
index (PI) of the user’s blood may be 1.24. Below this threshold value, the user’s blood
may contain impurities such as but not limited to blood clots, dirt in the fingernails and/or
others leading to false-positive hemoglobin values. This may result in false-positive
readings of hemoglobin concentration in the user’s blood.
15 In accordance with an embodiment of the present invention, the processing unit (135)
may include but not limited to a microcontroller unit, a microprocessor unit and/or the
like.
In an exemplary example, the processing unit (135) may include but not limited to an
Arduino Nano microcontroller, Arduino UNO microcontroller, Arduino Mega
20 microcontroller, Raspberry Pi, Teensy 3.2, STM32F103C8T6 ARM cortex
microcontroller and/or PIC16F877A microcontroller. In particular, the processing unit
(135) may be attached to a printed circuit board along with connecting wires, resistors,
capacitors and/or voltage regulators. Moreover, the processing unit (135) may have a
clock frequency of 240 MHz with reading-writing capabilities and 2 KB SRAM with 32 Kb
25 flash memories, 512 bytes of EEPROM to store the information of reading values from
the one or more photodetectors (125). Furthermore, the processing unit (135) may
operate in a voltage ranging from 2.2 volts to 5 volts.
In accordance with an embodiment of the present invention, the device (100) may be
configured with allied electronics comprising microcontrollers and/or biasing
30 components including but not limited to a battery module, a communication module
and/or a data acquisition system consisting of a memory module.
In accordance with an embodiment of the present invention, the processing unit (135)
processes the equivalent digital readings using moving average filter as part of signal
conditioning process for calculating data relating to hemoglobin concentration in the
35 user’s blood. In particular, the data obtained by the one or more photodetectors (125) is
at the peak (corresponding to the oxygenated blood data value) and crest
(corresponding to the de-oxygenated blood data value) of the pulse signal. In order to
achieve the values of the global peak and crest, the first derivative of the blood data
values is calculated by using the moving average filter to form a PPG graph.
40 In accordance with an embodiment of the present invention, the power supply unit (145)
is configured with the processing unit (135) for supplying power to operate the device
15
5 (100). In particular, the power supply unit (145) may be but not limited to a battery, a
power bank, supply from a passive device (100) and/or the like.
In an exemplary example, the battery may be a 12 V battery. Moreover, the battery may
be configured with a voltage regulator circuit for converting 12 V to 5 V. Moreover, the
power supply unit (145) may be a separate block within the device (100).
10 In accordance with an embodiment of the present invention, the switch (150) is
configured with the power supply unit (145) and the processing unit (135) for operating
the device (100).
In accordance with an embodiment of the present invention, the display unit (155) is
configured with the processing unit (135) for receiving the first digital signal and
15 displaying the first digital message.
In an exemplary embodiment, the first digital message may be “Please visit the nearby
doctor”.
Moreover, the display unit (155) receives the second digital signal from the processing
unit (135) and displays the second digital message.
20 In an embodiment, the second digital message may include data relating to hemoglobin
concentration in the user’s blood measured by the device (100).
Table 1 is a tabular representation illustrating an exemplary example of standard ranges
of hemoglobin concentration values in different types of user populations in accordance
with one or more embodiments of the present invention.
Population
Types
Anaemic Non-Anaemic
(in g/dL)
Hypoxia
Mild (in g/dL)
(in g/dL)
Moderate
(in g/dL)
Severe
(in g/dL)
Children (6 to
59 Months)
10.0 to
10.9
7.0 to 9.9 < 7.0 11.0 to 15.0 > 15
Children (5 to
11 Years)
11.0 to
11.4
8.0 to 10.9 < 8.0 11.5 to 15.5 > 15.5
Children (12 to
14 Years)
11.0 to
11.9
8.0 to 10.9 < 8.0 12.0 to 16.0 > 16
Men (Above
15 years)
11.0 to
12.9
8.0 to 10.9 < 8.0 13.0 to 17.0 > 17
Women
(Above 15
years)
11.0 to
11.9
8.0 to 10.9 < 8.0 12.0 to 16.0 > 16
Pregnant
Women
10.0 to
10.9
7.0 to 9.9 < 7.0 11.0 to 15.0 > 15
16
5 The processing unit (135) compares the hemoglobin concentration of the user
measured by the device (100) with the standard ranges of hemoglobin concentration
values in different types of user populations in accordance with Table 1.
In an exemplary embodiment, if the hemoglobin concentration of the user measured by
the device (100) is below the normal hemoglobin range for males and/or females, the
10 second digital message may be displayed as “Please visit the nearby doctor”.
In an exemplary embodiment of the present invention, the display unit (155) may be an
LCD (liquid crystal display) flat panel display unit (155). In particular, the LCD display
unit (155) may be made up of liquid crystal and polarizers. Moreover, the LCD display
unit (155) uses one line to display 16 characters and two lines to display the values.
15 Every character on the LCD is represented by a 5*7 pixel matrix. Furthermore, the
operating voltage ranges between 4.7 V to 5.3 V. It may be used in both 4 and/or 8 bit
modes.
Fig. 3 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the user’s blood in comparison with the actual hemoglobin
20 concentration in the user’s blood in accordance with one or more embodiments of the
present invention. In particular, the graph provides a comparative analysis of the
hemoglobin concentration in the users’ blood measured using the device (100) in
comparison with the actual hemoglobin concentration of different users determined
using the traditional method of pricking venepuncture as provided in the prior arts. The
25 graph also provides indication of divergence of the hemoglobin concentration in the
users’ blood measured using the device (100) in comparison with the actual hemoglobin
concentration of different users in terms of accuracy of prediction.
In accordance with an embodiment of the present invention, the device (100) may be
configured to measure hemoglobin concentration in the user’s blood with an accuracy of
30 about 98 % and/or with a maximum variation of about +/- 0.2 g/dl.
Fig. 4 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the users’ blood in comparison with the actual hemoglobin
concentration of users of different age groups in accordance with one or more
embodiments of the present invention. In particular, the graph provides a comparative
35 analysis of the hemoglobin concentration in the users’ blood measured using the device
(100) in comparison with the actual hemoglobin concentration of users of different age
groups determined using the traditional method of pricking venepuncture as provided in
the prior arts.
In accordance with another exemplary embodiment, the device (100) may be used for
40 non-invasively measuring hemoglobin concentration in users in the age range from 5
years to 85 years.
17
5 Fig. 5 is a graph illustrating accuracy of the device in non-invasively measuring
hemoglobin concentration in the users’ blood in comparison with the actual hemoglobin
concentration of male and female users in accordance with one or more embodiments
of the present invention. In particular, the graph provides a comparative analysis of the
hemoglobin concentration in the users’ blood measured using the device (100) in
10 comparison with the actual hemoglobin concentration of male and female users
determined using the traditional method of pricking venepuncture as provided in the
prior arts.
In accordance with an exemplary embodiment, the device (100) may be used for noninvasively measuring hemoglobin concentration in users including but not limited to
15 men, women, children, infants, pregnant women and/or elderly individuals.
In accordance with an embodiment of the present invention, the device (100) may be
configured to detect hemoglobin concentration in the user’s blood in the range of 5 g/dl
to 18 g/dl and/or with sensitivity of about 96 %.
In accordance with an embodiment of the present invention, the device (100) may be
20 configured to measure and/or display hemoglobin concentration in the user’s blood
within 1 minute. Alternatively, the device (100) may be configured to measure and/or
display hemoglobin concentration in the user’s blood within 45 seconds to 60 seconds.
In accordance with an embodiment of the present invention, the IoT (Internet of Things)
communication module (140) may be configured with the processing unit (135) for
25 wirelessly transmitting data relating to hemoglobin concentration in the user’s blood
measured by the device (100) to the cloud server (205). In particular, the user can
remotely access and/or monitor the data relating to hemoglobin concentration in the
blood measured by the device (100).
Referring to Fig. 6 illustrates a system (200) for non-invasively detecting, measuring
30 and/or monitoring hemoglobin concentration in a user’s blood in real-time. In particular,
the system (200) comprises the device (100), a cloud server (205) and a data analytics
unit (210). Moreover, the data analytics unit (210) may be configured with the cloud
server (205) for analyzing data relating to hemoglobin concentration in the user’s blood
measured by the device (100). Furthermore, the data analytics unit (210) may use an
35 artificial intelligence based predictive model for improving accuracy of the device (100)
for measuring hemoglobin concentration in the user’s blood based on one or more
parameters. Further, the one or more parameters may include age of the user, gender
of the user, SpO2 level of the user and/or pulse rate of the user.
In one embodiment of the present invention, the data analytics unit (210) may use the
40 artificial intelligence based predictive model for analyzing large volumes of data relating
to hemoglobin concentration in the user’s blood measured by the device (100);
18
5 identifying patterns indicating false-positive results, potential errors and/or discrepancies
in hemoglobin concentration in the user’s blood measured by the device (100);
providing real-time feedback based on the analyzed data during the hemoglobin
measurement process using the device (100) and/or facilitating better standardization
and calibration of the device (100) based on the analyzed data.
10 Fig. 7 illustrates a process for non-invasively detecting, measuring and/or monitoring
hemoglobin concentration in the user’s blood in real-time based on the device (100) and
the system (200). Method 700 starts at step 705 and proceeds to steps 710, 715, 720,
725, 730, 735, 740, 745, 750, 755, 760.
At Step 705, the user activates the switch (150) for turning ON the device (100).
15 At Step 710, the optical probe (110) receives the body part of the user. In particular, the
user’s body part may include but not limited to the finger and/or the toe. Moreover, the
one or more detection sensors (115) detect receiving of the body part of the user by the
optical probe (110).
At Step 715, the processing unit (135) automatically switches ON, on detecting
20 receiving of the body part of the user by the optical probe (110) using the one or more
detection sensors (115), the first optical source (120A) for continuously emitting the first
optical signal for the first predetermined time period while keeping the second optical
source (120B) switched OFF. In particular, the first optical signal may include a red light
in the range of 620 nm to 720 nm wavelength.
25 At Step 720, the processing unit (135) automatically switches ON, on completing the
first predetermined time period, the second optical source (120B) for continuously
emitting the second optical signal for the second predetermined time period while
keeping the first optical source (120A) switched OFF. In particular, the second optical
signal may include an infrared light in the range of 800 nm to 1100 nm wavelength.
30 Moreover, the first predetermined time period and/or the second predetermined time
period may be in the range of 10 seconds to 20 seconds each. Furthermore, the first
predetermined time period and/or the second predetermined time period may be of 15
seconds each.
At Step 725, the one or more photodetectors (125) detect transmitted optical signals
35 including the third optical signal transmitted from the body part of the user based on the
first optical signal and the fourth optical signal transmitted from the body part of the user
based on the second optical signal. The one or more photodetectors (125) process the
transmitted optical signals into equivalent current values. Moreover, distance between
the one or more optical sources (120) and/or the one or more photodetectors (125) is
40 kept constant in the range of 15 mm to 25 mm. In particular, the distance between the
19
5 one or more optical sources (120) and/or the one or more photodetectors (125) may be
20 mm.
At Step 730, the one or more amplifiers (130) process the equivalent current values into
equivalent voltage values.
At Step 735, the processing unit (135) processes the equivalent voltage values into
10 equivalent digital readings. In particular, the processing unit (135) may record 200
digital readings in a time period of 30 seconds. Moreover, the processing unit (135)
digitally conditions, filters and/or processes the equivalent voltage values into equivalent
digital readings.
At Step 740, the processing unit (135) determines perfusion index (PI) of the user’s
15 blood using the equivalent digital readings. In case the perfusion index (PI) of the user’s
blood is below the threshold value of 1.24, the method proceeds to Step 645, else the
method proceeds to Step 650.
At Step 745, the processing unit (135) halts the processing operation and transmits the
first digital signal to the display unit (155) for displaying the first digital message. In an
20 exemplary embodiment, the first digital message may be “Please visit the nearby
doctor”. The method is restarted at Step 605.
At Step 750, if the perfusion index (PI) of the user’s blood is equal to or above the
threshold value of 1.24, the processing unit (135) calculates data relating to hemoglobin
concentration in the user’s blood based on the equivalent digital readings. The
25 processing unit (135) further transmits the second digital signal to the display unit (155)
for displaying the second digital message. In particular, the processing unit (135)
processes the equivalent digital readings using moving average filter as part of the
signal conditioning process for calculating data relating to hemoglobin concentration in
the user’s blood. Moreover, the IoT (Internet of Things) communication module (140) is
30 configured with the processing unit (135) to wirelessly transmit, to the cloud server
(205), data relating to hemoglobin concentration in the user’s blood measured by the
device (100). Furthermore, the user can remotely access and/or monitor data relating to
hemoglobin concentration in the blood measured by the device (100) though the cloud
server (205). Further, the data analytics unit (210) configured with the cloud server
35 (205) may use an artificial intelligence based predictive model for improving accuracy of
the device (100) for measuring hemoglobin concentration in the user’s blood based on
one or more parameters. And, the one or more parameters may include age of the user,
gender of the user, SpO2 level of the user and/or pulse rate of the user.
At Step 755, the display unit (155) displays the first digital message based on the first
40 digital signal received from the processing unit (135) and/or the second digital message
based on the second digital signal received from the processing unit (135). In particular,
20
5 the second digital message may include data relating to hemoglobin concentration in
the user’s blood measured by the device (100).
At Step 760, the device (100) is turned OFF by the user by deactivating the switch
(150). In particular, the device (100) may be configured to measure and/or display
hemoglobin concentration in the user’s blood within 45 seconds to 60 seconds.
10 In accordance with an embodiment of the present invention, the device (100) may also
be configured to measure physiological parameters including but not limited to SpO2,
pulse rate and/or the like.
ADVANTAGES
? The present invention can be used to advantageously measure hemoglobin
15 concentration in the user’s blood using fingers and/or toes as well. In particular,
this may be advantageous for determining hemoglobin concentration of user’s
having amputation, diseased conditions and/or injured or damaged body parts.
? The present invention provides a point of care and portable device (100) for noninvasively detecting, measuring and/or monitoring hemoglobin concentration in
20 the user’s blood in real-time, thereby bypassing traditional means of hemoglobin
detection requiring extraction of blood from the user.
? The device (100) can be used for detecting hemoglobin concentration in user’s
having anemia and/or anemia-associated diseases.
? The device (100) is cost-effective for the user and provides accurate results for
25 hemoglobin concentration in a short processing time. The device (100) does not
require any blood sample and is therefore painless, having no risk of infection.
? The present invention may be used for non-invasively measuring hemoglobin
concentration in men, women, children, infants, pregnant women and/or elderly
individuals in the age ranging from 5 years to 85 years.
30 ? The device (100) does not require any medical expertise and can be used as an
OTC device (100), as well as a POC device (100) that can be used by any
layman, for self-diagnosis. It can also be an assistance tool for doctors and
medical professionals, including hospitals, alike.
WORKING EXAMPLES
35 Example 1 :- Dimensions of the device (100) components
Table 2 is a tabular representation illustrating an exemplary example of dimensions of
the device (100) in accordance with one or more embodiments of the present invention.
Components Population Type Dimension (in mm)
Distance between the one or more For Adults 20
21
optical sources (120) and the one or
more photodetectors (125)
For Children 16
Diameter of the optical probe (110) For Adults 22
For Children 15
5
Example 2 :- Accuracy levels for different body parts of the user
Table 3 is a tabular representation illustrating an exemplary example of accuracy levels
of the hemoglobin concentration measured using different body parts of 2 users in
accordance with one or more embodiments of the present invention.
Body Part of the User Data Accuracy
Predicted Actual Error
Hand (Thumb) 13.5 12.7 0.8 ~ 81 %
12.89 13.6 0.71
Hand (Index Finger) 12.75 12.7 0.05 ~ 98 %
13.63 13.6 0.03
Hand (Middle Finger) 13.46 12.7 0.76 ~ 84 %
14 13.6 0.4
Hand (Fourth Finger) 13.52 12.7 0.82 ~ 90 %
14.32 13.6 0.72
Hand (Fifth Finger) 12.5 12.7 0.2 ~ 93 %
13.76 13.6 0.16
Toe 11.5 12.7 1.2 ~ 78 %
12.14 13.6 1.46
10
In accordance with Table 3, the accuracy levels of the hemoglobin concentration
measured by the device (100) using different body parts of the user lies in the range of
78 % to 98 %.
Example 3 :- Accuracy levels for variable number of readings in a timeframe
15 Table 4 is a tabular representation illustrating an exemplary example of accuracy levels
of the hemoglobin concentrations of 3 users involving recording of variable number of
readings in the timeframe of 15 seconds by the one or more photodetectors (125) in
accordance with one or more embodiments of the present invention.
No. of
readings
recorded in
15 seconds
Data Accurac
y levels
Observations
Predict
ed
Actual Error
50 12.3 12.7 0.4 ~ 85 % Less data points, leading
8.6 7.9 0.7 to underfitting
22
14.03 13.6 0.43
100 12.5 12.7 0.2 ~ 92 % Moderate data points,
leading to moderate
accuracy
8.4 7.9 0.5
13.89 13.6 0.29
200 12.75 12.7 0.05 ~ 98 % Optimum data points,
leading to highest
accuracy
8 7.9 0.1
13.63 13.6 0.03
300 12.56 12.7 0.14 ~ 89 % Higher number of data
points, leading to less
accuracy
8.32 7.9 0.42
13.33 13.6 0.27
400 12.23 12.7 0.47 ~ 76 % Highest number of data
points, leading to
overfitting
8.65 7.9 0.73
13.0 13.6 0.6
5
In accordance with Table 4, the accuracy levels of the hemoglobin concentration
measured by recording variable number of readings in the timeframe of 15 seconds by
the one or more photodetectors (125) lies in the range of 76 % to 98 %.
Example 4 :- Accuracy levels for moving average filter (MAF) as part of signal
10 conditioning process along with the Perfusion Index (PI) threshold
Table 5 is a tabular representation illustrating an exemplary example of accuracy levels
of the hemoglobin concentration in the user’s blood of 3 users measured by considering
moving average filter (MAF) as part of signal conditioning process along with the
Perfusion Index (PI) threshold in accordance with one or more embodiments of the
15 present invention.
S.No. Data Accuracy
Levels
Observations
Predicted Actual Error
Condition 1 :-
Calculating
Hemoglobin
concentration without
applying moving
average filter (MAF)
and Perfusion Index
(PI) threshold.
13.9 12.7 1.2 ~ 75 % Very less accuracy
due to addition of
noise signals (as
MAF not applied) and
impurities in blood
(as Perfusion Index
(PI) threshold not
applied)
10 7.9 2.1
14 13.6 0.4
Condition 2 :-
Calculating
Hemoglobin
concentration without
applying Perfusion
Index (PI) threshold,
but with moving
12.3 12.7 0.4 ~ 83 % Less accuracy due to
impurities in blood
(as Perfusion Index
(PI) threshold not
applied). However,
noise signals are
removed (as MAF is
9.23 7.9 1.33
13.0 13.6 0.6
23
average filter (MAF). applied).
Condition 3 :-
Calculating
Hemoglobin
concentration without
applying moving
average filter (MAF),
but with Perfusion
Index (PI) threshold.
13 12.7 0.3 ~ 86 % Less accuracy due to
addition of noise
signals (as MAF not
applied). However, it
can be determined
that the blood
contains impurities
and medical attention
is needed can be
devised (as Perfusion
Index (PI) threshold
is applied)
8.51 7.9 0.61
13.47 13.6 0.13
Condition 4 :-
Calculating
Hemoglobin
concentration by
applying moving
average filter (MAF)
and Perfusion Index
(PI) threshold.
12.75 12.7 0.05 ~ 98 % Accurate results as
noise signals are
removed (as MAF is
applied). Moreover, it
can be determined
that the blood
contains impurities
and medical attention
is needed can be
devised (as Perfusion
Index (PI) threshold
is applied)
8 7.9 0.1
13.63 13.6 0.03
5
In accordance with Table 5, the accuracy levels of the hemoglobin concentration
measured by considering moving average filter (MAF) as part of signal conditioning
process along with the Perfusion Index (PI) threshold is about 98 %.
Example 5 :- Process for measuring hemoglobin concentration in the user’s
10 blood in real-time using the device (100)
Step 1 :- Switching ON the Red LED (of 660 nm wavelength) and keeping the Infrared
LED (of 940 nm wavelength) OFF. The readings detected by the one or more
photodetectors (125) of the RED LED are saved.
Step 2 :- Switching OFF the Red LED and turning ON the Infrared LED. The readings
15 detected by the one or more photodetectors (125) of the Infrared LED are saved.
Step 3 :- Applying Moving Averaging Filter (MAF) for the readings of Red LED and
Infrared LED separately.
24
5 Step 4 :- Determining the highest and lowest readings of Red LED readings and
Infrared LED readings from the PPG graph and saving them as REDmaximum, REDminimum,
IRmaximum, and IRminimum.
Step 5 :- Calculating the following ratios :
Ratio of RED LED =
REDmaximum - REDminimum
REDmaximum
Ratio of IR LED =
IRmaximum - IRminimum
IRmaximum 10
Step 6 :- Calculating the Perfusion Index (PI), wherein Perfusion Index (PI) is equal to
the Ratio of IR LED calculated from the above steps. Using Photoplethysmography
(PPG) method, Perfusion Index (PI) can be determined as :
Perfusion Index (PI) =
AC component of IR Reading
DC component of IR Reading * 100
15 In case the PI is greater than or equal to 1.24, the method proceeds to further steps.
Alternatively, if the PI is less than 1.24, the display unit (155) displays “Please visit the
doctor” and the method is restarted from Step 1.
Step 7 :- Using the modified Beer-Lambert's Law for predicting the hemoglobin
concentration by finding the concentrations of oxyhemoglobin (HbO2) and
20 deoxyhemoglobin (HHb). Formula for Beer-Lambert's Law is :
A = ?. C. d. DPF
wherein A = Absorbance,
? = Absorbance Coefficient,
C = Concentration,
25 d = optical length,
DPF = Differential Path Factor.
DPF consists of Refractive Index (i.e. 1.36) and minimum density of blood (i.e. 1.24).
For finding the hemoglobin concentration in the user’s blood, the Beer Lambert's Law
becomes :
?? =
??
?. d.DPF 30
25
5 Simplifying for 2 different wavelengths, the calculation becomes a Matrix calculation as
follows:
[
????1
????2
] = [
???1??????
???1??????2
???2??????
???2??????2
].[
????????
????????2
]. ??
Finding CHHb and CHbO2 so the matrix becomes
[
????????
????????2
] = [
???1??????
???1??????2
???2??????
???2??????2
]
-1
.[
????1
????2
].
1
??.??????
10 Step 8 :- Calculating total Hemoglobin levels, wherein
Total Hemoglobin = CHHb + CHbO2
Step 9 :- Displaying the Total Hemoglobin on the display unit (155).
Hence, the Total Hemoglobin in the user’s blood is measured using the present
invention and displayed in g/dl.
15 Example 6 :- Example for measuring hemoglobin concentration in the user’s
blood in real-time using the device (100)
Hemoglobin concentration in a user’s blood was non-invasively determined using the
device (100). Following are the calculations made by the processing unit (135) :-
REDmaximum = 163
20 REDminimum = 33
IRmaximum = 117
IRminimum = 23
?????????????????????? =
163 - 33
33 = 4.0
???????????????????? =
117 - 23
23 = 4.1
25 Calculating in Matrix form using optical distance and absorbance coefficient, we get
[
10.199 -2.725
-6.747 27.248][
4.0
4.1
] = [
????????
????????2
]
CHHB = 29.6235
26
5 CHbO2 = 84.7488
CHHB + CHbO2 = 29.6235 + 84.7488 = 114.3528
Multiplying the obtained values by a blood density factor of 0.105, we get
114.3528 * 0.105 = 12.01
Hence, the Total Hemoglobin in the user’s blood, measured using the present invention,
10 was 12.01 g/dl.
Example 7 :- Accuracy levels for different types of users
Table 6 is a tabular representation illustrating an exemplary example of accuracy levels
of the hemoglobin concentration of 10 users of different ages and genders, measured
using the device (100) in accordance with one or more embodiments of the present
15 invention.
User Age
(in
year
s)
Gender Actual
hemoglobin
(in g/dL)
Predicted
hemoglobin
(in g/dL)
Difference
(in g/dL)
Error
(in
g/dL)
Accuracy
(in %)
User 1 23 Male 13.3 13.5 0.2 0.02 98.50
User 2 27 Female 13.3 13.2 0.1 0.01 99.25
User 3 31 Male 15 14.76 0.24 0.02 98.4
User 4 37 Female 11.8 11.67 0.13 0.01 98.90
User 5 43 Female 11.1 11.32 0.22 0.02 98.02
User 6 24 Male 17 16.87 0.13 0.01 99.24
User 7 55 Female 13 13.1 0.1 0.01 99.23
User 8 16 Female 11.7 11.8 0.1 0.01 99.14
User 9 60 Female 8.8 8.76 0.04 0.01 99.54
User 10 90 Female 6.7 6.9 0.2 0.03 97.01
Average Accuracy (in %) = 98.72
In accordance with Table 6, the accuracy levels of the hemoglobin concentration of 10
users of different ages and genders, measured using the device (100) is about 98.72 %.
It will be apparent to those skilled in the art that other embodiments of the invention will
20 be apparent to those skilled in the art from consideration of the specification and
practice of the invention. While the foregoing written description of the invention enables
one of ordinary skill to make and use what is considered presently to be the best mode
thereof, those of ordinary skill will understand and appreciate the existence of
variations, combinations, and equivalents of the specific embodiment, method, and
25 examples herein. The invention should therefore not be limited by the above described
27
5 embodiment, method, and examples, but by all embodiments and methods within the
scope of the invention. It is intended that the specification and examples be considered
as exemplary, with the true scope of the invention being indicated by the claims.
A person of ordinary skill in the art will appreciate that embodiments and exemplary
scenarios of the disclosed subject matter may be practiced with various computer
10 system configurations, including multicore multiprocessor systems, minicomputers,
mainframe computers, computers linked or clustered with distributed functions, as well
as pervasive or miniature computers that may be embedded into virtually any device.
Further, the operations may be described as a sequential process, however some of the
operations may in fact be performed in parallel, concurrently, and/or in a distributed
15 environment, and with program code stored locally or remotely for access by single or
multiprocessor machines. In addition, in some embodiments, the order of operations
may be rearranged without departing from the spirit of the disclosed subject matter.
It is to be understood that the terms so used are interchangeable under appropriate
circumstances and embodiments of the invention are capable of operating according to
20 the present invention in other sequences, or in orientations different from the one(s)
described or illustrated above. ,CLAIMS:1. A device (100) for non-invasively detecting, measuring and/or monitoring
hemoglobin concentration in a user’s blood in real-time comprising:
10 a. an optically isolated compartment (105), for minimizing optical interference from
ambient light, comprising:
an optical probe (110) for receiving a body part of the user;
15 one or more detection sensors (115), configured inside the optical probe (110)
and with a processing unit (135), for detecting receiving of the body part of the
user by the optical probe (110);
one or more optical sources (120) including a first optical source (120A) and a
20 second optical source (120B), both configured on one side of the optical probe
(110);
wherein the processing unit (135), on detecting receiving of the body part of the
user by the optical probe (110) using the one or more detection sensors (115),
25 automatically switches ON the first optical source (120A) for continuously
emitting a first optical signal for a first predetermined time period while keeping
the second optical source (120B) switched OFF;
wherein the processing unit (135) automatically switches ON the second optical
30 source (120B), on completing the first predetermined time period, for
continuously emitting a second optical signal for a second predetermined time
period while keeping the first optical source (120A) switched OFF;
one or more photodetectors (125), configured on other side of the optical probe
35 (110) opposite to the one or more optical sources (120), for detecting transmitted
optical signals including a third optical signal transmitted from the body part of
the user based on the first optical signal and a fourth optical signal transmitted
from the body part of the user based on the second optical signal;
40 wherein the one or more photodetectors (125) process the transmitted optical
signals into equivalent current values; wherein distance between the one or more
optical sources (120) and/or the one or more photodetectors (125) is kept
constant;
29
5
b. one or more amplifiers (130) configured with the one or more photodetectors
(125) for processing the equivalent current values into equivalent voltage values;
c. the processing unit (135) connected with the one or more photodetectors (125)
10 for digitally conditioning, filtering and/or processing the equivalent voltage values
into equivalent digital readings; wherein the processing unit (135) determines
perfusion index (PI) of the user’s blood using the equivalent digital readings;
wherein the processing unit (135) –
i. halts processing operation, in case the perfusion index (PI) of the user’s
15 blood is below a threshold value, and transmits a first digital signal to a
display unit (155) for displaying a first digital message; and/or
ii. calculates, in case the perfusion index (PI) of the user’s blood is equal to
or above the threshold value, data relating to hemoglobin concentration in
the user’s blood; wherein the processing unit (135) transmits a second
20 digital signal to the display unit (155) for displaying a second digital
message including the data relating to hemoglobin concentration in the
user’s blood;
d. an IoT (Internet of Things) communication module (140) configured with the
25 processing unit (135) for wirelessly transmitting, to a cloud server (205), data
relating to hemoglobin concentration in the user’s blood measured by the device
(100); wherein the user can remotely access and/or monitor data relating to
hemoglobin concentration in the blood measured by the device (100) through the
cloud server (205);
30
e. a power supply unit (145) configured with the processing unit (135) for supplying
power to operate the device (100);
f. a switch (150) configured with the power supply unit (145) and the processing
35 unit (135) for operating the device (100); and
g. the display unit (155) configured with the processing unit (135) for –
(i.) receiving the first digital signal and displaying the first digital message;
and/or
40 (ii.) receiving the second digital signal and displaying the second digital
message; wherein the second digital message may include data relating
to hemoglobin concentration in the user’s blood measured by the device
(100).
30

2. The device (100) as claimed in claim 1, wherein the threshold value relating to the
perfusion index (PI) of the user’s blood may be 1.24

3. The device (100) as claimed in claim 1, wherein the first predetermined time period
and/or the second predetermined time period may be in the range of 10 seconds to
10 20 seconds each.

4. The device (100) as claimed in claim 1, wherein the device (100) may be configured
to measure hemoglobin concentration in the user’s blood using the user’s body parts
including but not limited to a finger and/or a toe.
15

5. The device (100) as claimed in claim 1, wherein the first optical signal may include a
red light in the range of 620 nm to 720 nm wavelength and the second optical signal
may include an infrared light in the range of 800 nm to 1100 nm wavelength.

6. The device (100) as claimed in claim 1, wherein the device (100) may be configured
to detect hemoglobin concentration in the user’s blood in the range of 5 g/dl to 18
g/dl and/or with sensitivity of about 96 %.

7. The device (100) as claimed in claim 1, wherein the device (100) may be configured
25 to measure and/or display hemoglobin concentration in the user’s blood within 45
seconds to 60 seconds.

8. The device (100) as claimed in claim 1, wherein the device (100) may be configured
to measure hemoglobin concentration in the user’s blood with an accuracy of about
30 98 % and/or with a maximum variation of about +/- 0.2 g/dl.

9. The device (100) as claimed in claim 1, wherein the processing unit (135) may be
configured for sequentially switching ON the first optical source (120A) and/or the
second optical source (120B) for recording 200 digital readings in a time period of 30
35 seconds.

10.A system (200) for non-invasively detecting, measuring and/or monitoring
hemoglobin concentration in a user’s blood in real-time comprising:
40 a device (100) for non-invasively detecting, measuring and/or monitoring hemoglobin
concentration in a user’s blood in real-time comprising:
a. an optically isolated compartment (105), for minimizing optical interference
from ambient light, comprising:
31
5 an optical probe (110) for receiving a body part of the user;
one or more detection sensors (115), configured inside the optical probe
(110) and with a processing unit (135), for detecting receiving of the body part
of the user by the optical probe (110);
10
one or more optical sources (120) including a first optical source (120A) and a
second optical source (120B), both configured on one side of the optical
probe (110);
15 wherein the processing unit (135), on detecting receiving of the body part of
the user by the optical probe (110) using the one or more detection sensors
(115), automatically switches ON the first optical source (120A) for
continuously emitting a first optical signal for a first predetermined time period
while keeping the second optical source (120B) switched OFF;
20
wherein the processing unit (135) automatically switches ON the second
optical source (120B), on completing the first predetermined time period, for
continuously emitting a second optical signal for a second predetermined time
period while keeping the first optical source (120A) switched OFF;
25
one or more photodetectors (125), configured on other side of the optical
probe (110) opposite to the one or more optical sources (120), for detecting
transmitted optical signals including a third optical signal transmitted from the
body part of the user based on the first optical signal and a fourth optical
30 signal transmitted from the body part of the user based on the second optical
signal;
wherein the one or more photodetectors (125) process the transmitted optical
signals into equivalent current values; wherein distance between the one or
35 more optical sources (120) and/or the one or more photodetectors (125) is
kept constant;
b. one or more amplifiers (130) configured with the one or more photodetectors
(125) for processing the equivalent current values into equivalent voltage
40 values;
c. the processing unit (135) connected with the one or more photodetectors
(125) for digitally conditioning, filtering and/or processing the equivalent
voltage values into equivalent digital readings; wherein the processing unit
32
5 (135) determines perfusion index (PI) of the user’s blood using the equivalent
digital readings;
wherein the processing unit (135) –
(i.) halts processing operation, in case the perfusion index (PI) of the
10 user’s blood is below a threshold value, and transmits a first digital
signal to a display unit (155) for displaying a first digital message;
and/or
(ii.) calculates, in case the perfusion index (PI) of the user’s blood is equal
to or above the threshold value, data relating to hemoglobin
15 concentration in the user’s blood; wherein the processing unit (135)
transmits a second digital signal to the display unit (155) for displaying
a second digital message including the data relating to hemoglobin
concentration in the user’s blood;
20 d. an IoT (Internet of Things) communication module (140) configured with the
processing unit (135) for wirelessly transmitting, to a cloud server (205), data
relating to hemoglobin concentration in the user’s blood measured by the
device (100); wherein the user can remotely access and/or monitor data
relating to hemoglobin concentration in the blood measured by the device
25 (100) through the cloud server (205);
e. a power supply unit (145) configured with the processing unit (135) for
supplying power to operate the device (100);
30 f. a switch (150) configured with the power supply unit (145) and the processing
unit (135) for operating the device (100); and
g. the display unit (155) configured with the processing unit (135) for –
(i.) receiving the first digital signal and displaying the first digital message;
35 and/or
(ii.) receiving the second digital signal and displaying the second digital
message; wherein the second digital message may include data relating
to hemoglobin concentration in the user’s blood measured by the device
(100);
40 the cloud server (205) configured for receiving data relating to hemoglobin
concentration in the user’s blood measured by the device (100) from the IoT (Internet of
Things) communication module (140); wherein the user can remotely access and/or
monitor data relating to hemoglobin concentration in the blood measured by the device
(100) through the cloud server (205); and
33
5 a data analytics unit (210) configured with the cloud server (205) for analyzing data
relating to hemoglobin concentration in the user’s blood measured by the device (100);
wherein the data analytics unit (210) may use an artificial intelligence based predictive
model for improving accuracy of the device (100) for measuring hemoglobin
concentration in the user’s blood based on one or more parameters; wherein the one or
10 more parameters may include age of the user, gender of the user, SpO2 level of the
user and/or pulse rate of the user.

11.A process for non-invasively detecting, measuring and/or monitoring hemoglobin
concentration in a user’s blood in real-time based on the system (200) as claimed in
claim 10, comprising the steps of :
15
a. activating, by the user, a switch (150) for turning ON the device (100);
b. receiving, by an optical probe (110), a body part of the user; wherein the user’s body
part may include a finger and/or a toe; wherein one or more detection sensors (115)
20 are configured to detect receiving of the body part of the user by the optical probe
(110);
c. automatically switching ON, by a processing unit (135) on detecting receiving of the
body part of the user by the optical probe (110) using the one or more detection
25 sensors (115), a first optical source (120A) for continuously emitting a first optical
signal for a first predetermined time period while keeping a second optical source
(120B) switched OFF; wherein the first optical signal may include a red light in the
range of 620 nm to 720 nm wavelength;
30 d. automatically switching ON, by the processing unit (135) on completing the first
predetermined time period, a second optical source (120B) for continuously emitting
a second optical signal for a second predetermined time period while keeping the
first optical source (120A) switched OFF; wherein the second optical signal may
include an infrared light in the range of 800 nm to 1100 nm wavelength; wherein the
35 first predetermined time period and/or the second predetermined time period may be
in the range of 10 seconds to 20 seconds each;
e. detecting, by one or more photodetectors (125), transmitted optical signals including
a third optical signal transmitted from the body part of the user based on the first
40 optical signal and a fourth optical signal transmitted from the body part of the user
based on the second optical signal;
34
5 wherein the one or more photodetectors (125) process the transmitted optical
signals into equivalent current values; wherein distance between the one or more
optical sources (120) and/or the one or more photodetectors (125) is kept constant;
f. processing, by one or more amplifiers (130), the equivalent current values into
10 equivalent voltage values;
g. processing, by the processing unit (135), the equivalent voltage values into
equivalent digital readings; wherein the processing unit (135) may record 200 digital
readings in a time period of 30 seconds; wherein the processing unit (135) digitally
15 conditions, filters and/or processes the equivalent voltage values into equivalent
digital readings;
h. determining, by the processing unit (135), perfusion index (PI) of the user’s blood
using the equivalent digital readings; wherein the processing unit (135) –
20 (i.) halts processing operation, in case the perfusion index (PI) of the user’s blood
is below a threshold value, and transmits a first digital signal to a display unit
(155) for displaying a first digital message; and/or
(ii.) calculates, in case the perfusion index (PI) of the user’s blood is equal to or
above the threshold value, data relating to hemoglobin concentration in the
25 user’s blood based on the equivalent digital readings;
wherein the processing unit (135) processes the equivalent digital readings
using moving average filter as part of signal conditioning process for
calculating data relating to hemoglobin concentration in the user’s blood;
30 wherein the processing unit (135) transmits a second digital signal to the
display unit (155) for displaying a second digital message;
wherein the threshold value relating to the perfusion index (PI) of the user’s
blood may be 1.24;
35
wherein an IoT (Internet of Things) communication module (140) configured
with the processing unit (135) may wirelessly transmit, to a cloud server
(205), data relating to hemoglobin concentration in the user’s blood measured
by the device (100); wherein the user can remotely access and/or monitor
40 data relating to hemoglobin concentration in the blood measured by the
device (100) though the cloud server (205); wherein a data analytics unit
(210) configured with the cloud server (205) may use an artificial intelligence
based predictive model for improving accuracy of the device (100) for
measuring hemoglobin concentration in the user’s blood based on one or
35
5 more parameters; wherein the one or more parameters may include age of
the user, gender of the user, SpO2 level of the user and/or pulse rate of the
user;
i. displaying, by the display unit (155) -
10 (i.) the first digital message based on the first digital signal received from the
processing unit (135); and/or
(ii.) the second digital message based on the second digital signal received from
the processing unit (135); wherein the second digital message may include
data relating to hemoglobin concentration in the user’s blood measured by the
15 device (100);
j. deactivating the switch (150) for turning OFF the device (100);
wherein the device (100) may be configured to measure and/or display hemoglobin
concentration in the user’s blood within 45 seconds to 60 seconds.