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Continuous non-invasive monitoring of bilirubin

When red blood cells break down, a substance called bilirubin is formed. Babies are not easily able to get rid of the bilirubin and it can build up in the blood and other tissues and fluids of the baby's body. Presently, there is no point-of-care system available to measure the baby’s bilirubin level at home, at certain pre-defined intervals. The patent proposes a method to monitor bilirubin levels at home without using invasive techniques.

About Company

Based on patent titled A DEVICE FOR THE CONTINUOUS NON-INVASIVE MONITORING OF BILIRUBIN IN REALTIME published By Ibrum Technologies

1 Introduction and key takeaways

<p><strong>Problem statement:</strong></p> <p><a href="https://www.chop.edu/conditions-diseases/hyperbilirubinemia-and-jaundice#:~:text=Hyperbilirubinemia%20is%20a%20condition%20in,the%20first%20week%20of%20life.">Hyperbilirubinemia</a> is a condition in which there is too much bilirubin in the blood. Severe hyperbilirubinemia can lead to acute bilirubin encephalopathy or kernicterus. <strong>Total serum bilirubin</strong> is commonly determined by spectrophotometric methods by analysing plasma or serum sample.&nbsp;</p> <p>Checking bilirubin levels after birth at pre-defined intervals involves multiple needle pricks. Presently, there is no point-of-care system available to measure the baby’s bilirubin level at home, at certain pre-defined intervals.</p> <p><strong>Solution:</strong></p> <p><em>This patent proposes a method to measure the bilirubin levels in babies using a wrist wearable device and efficiently monitor the parameters at home without human intervention.</em></p> <p><strong>Key takeaways</strong> of the patent:</p> <p>1. A <strong>wearable wrist device</strong> is provided for measuring bilirubin levels non-invasively. It is housed in a waterproof/splashproof body.</p> <p>2. The <strong>visible light radiations</strong> of multiple wavelengths and infrared light is used to detect and measure different parameters such as melanin, oxygenated and deoxygenated haemoglobin,&nbsp; glycated haemoglobin, bilirubin, water and albumin.</p> <p>3. A display unit is provided in the device which displays the <strong>current level of bilirubin</strong> at certain pre-defined intervals in real-time, along with the <strong>degree of severity</strong>.</p> <p>4. A <strong>learning module</strong> is configured to analyse the effectiveness of an ongoing therapy at the current settings and recommend the best settings and automatically <strong>change phototherapy settings without human intervention</strong>;</p>

2 Wearable device

1

FIG. 1 shows a diagram of the wearable wrist device.

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Wearable biocompatible, adjustable and detachable strap 104.

4

The feedback through the wireless connectivity facilitator 102 may be transmitted to an application on a handheld device, a compatible phototherapy unit and to a central nursing station.

3

Display Unit 101.

2

The bilirubin and temperature measuring module 100 comprises of light emitting sources, a microprocessor, photodetectors and a filter.

<p><strong>FIG. 1</strong> shows a diagram of the wearable wrist device for measuring bilirubin levels.</p>

3 Wearable device (bottom view)

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Battery and charging unit 201.

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Photodetectors 202 detect, collect and amplify the reflected light from a patient’s body.

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FIG. 2 shows a diagram of the wearable device.

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Light-emitting source 203 emits visible light radiations of multiple wavelengths and infrared light. The different wavelengths are used to measure different parameters such as melanin, oxygenated and deoxygenated haemoglobin, bilirubin, water and albumin.

<p><strong>FIG. 2</strong> shows a diagram of the bottom view of the wearable device to measure bilirubin levels.</p> <p>The bilirubin and temperature measuring module comprises light-emitting sources <strong>203</strong> that emit visible light radiations of multiple wavelengths and infrared light.</p> <p>The wearable biocompatible strap <strong>104 </strong>(Figure 1) is adjustable and detachable and is configured to mount the device on a patient, with the said biocompatible strap being single-use or multi-use.</p> <p>The display unit <strong>101 </strong>(Figure 1) comprises an indicator light that is disposed on a top portion of the device, and displays the current level of bilirubin at certain pre-defined intervals in real-time, along with the degree of severity.</p> <p>The learning module is configured to analyse the measured bilirubin levels at the current settings and recommend the best settings, thereby facilitating the changing of phototherapy settings without human intervention.</p> <p>The battery and charging unit <strong>201</strong> comprise a rechargeable battery. Switch <strong>103 </strong>(Figure 1) is used for powering the device on or off.</p>

4 Bilirubin monitoring process

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Bilirubin and body temperature are measured and shown on the display unit.

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The therapeutic unit uses algorithms to control the target system.

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FIG. 3 shows a flowchart of the bilirubin detecting and monitoring process.

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Measured data is transmitted via wireless connection to mobile device, nursing station or therapeutic unit.

<p><strong>FIG. 3</strong> shows a flowchart of the bilirubin detection, measurement and monitoring process.</p>

5 Understanding the claims

<p><strong>Primary claim</strong> of the patent:</p> <p>1. A &nbsp;device &nbsp;(300) &nbsp;for &nbsp;the &nbsp;continuous &nbsp;and &nbsp;real-time &nbsp;monitoring &nbsp;of &nbsp;bilirubin, ( @@h2 )<br> comprising:<br> a &nbsp;&nbsp;housing &nbsp;&nbsp;that &nbsp;&nbsp;encloses &nbsp;&nbsp;a &nbsp;&nbsp;waterproof/splash &nbsp;&nbsp;proof &nbsp;&nbsp;body, &nbsp;&nbsp;said &nbsp;&nbsp;body <br> comprising: a bilirubin and temperature measuring module (100) that comprises: ( @@h2 )<br> one &nbsp;or &nbsp;more &nbsp;light &nbsp;emitting &nbsp;sources &nbsp;(203) &nbsp;that &nbsp;emit &nbsp;visible &nbsp;light <br> radiations of multiple wavelengths and infrared light, said multiple wavelengths ranging &nbsp;between &nbsp;350 &nbsp;nm &nbsp;and &nbsp;1,200 &nbsp;nm, with the wavelength &nbsp;of &nbsp;at &nbsp;least &nbsp;one &nbsp;light &nbsp;radiation &nbsp;corresponding to &nbsp;the isosbestic point of bilirubin absorption; ( @@h3 )<br> a &nbsp;microprocessor that &nbsp;is &nbsp;configured &nbsp;to &nbsp;monitor &nbsp;and &nbsp;control &nbsp;the functioning of the device (300); <br> one &nbsp;or &nbsp;more &nbsp;photodetectors &nbsp;to &nbsp;detect, &nbsp;collect, &nbsp;and amplify the reflected &nbsp;light &nbsp;from &nbsp;a &nbsp;patient’s &nbsp;body, &nbsp;said &nbsp;one &nbsp;or &nbsp;more photodetectors &nbsp;(202) &nbsp;being &nbsp;disposed &nbsp;in &nbsp;close &nbsp;proximity &nbsp;to &nbsp;the one or more light emitting sources (203), and being separated from the one or more light emitting sources (203) by a blocking channel; ( @@h3 )<br> a filter that removes unwanted noise, and an &nbsp;analogue &nbsp;to &nbsp;digital &nbsp;converter, &nbsp;the &nbsp;output &nbsp;of &nbsp;which &nbsp;is &nbsp;processed to get the bilirubin level in real-time; <br> a &nbsp;wearable &nbsp;biocompatible &nbsp;strap &nbsp;(104) &nbsp;that &nbsp;is &nbsp;adjustable and &nbsp;detachable, said biocompatible strap (104) being configured to mount the device (300) on a patient, with said biocompatible strap (104) being single use or multi-use; ( @@h2 )<br> a buckle (205); ( @@h3 )<br> a display unit (101) comprising an indicator light that is disposed on a top portion &nbsp;of &nbsp;the &nbsp;device (300), said &nbsp;display &nbsp;unit &nbsp;(101) &nbsp;displaying &nbsp;the &nbsp;current level &nbsp;of &nbsp;bilirubin &nbsp;at &nbsp;certain &nbsp;pre-defined intervals &nbsp;in &nbsp;real-time, &nbsp;along &nbsp;with the degree of severity, with said indicator light being a low intensity light which doesn’t cause any biological damage to tissues, or does not interfere with a phototherapy unit; ( @@h2 )<br> a safety module; <br> a &nbsp;learning &nbsp;module that &nbsp;is &nbsp;configured &nbsp;to &nbsp;analyse the &nbsp;effectiveness &nbsp;of &nbsp;an &nbsp;ongoing &nbsp;therapy &nbsp;at &nbsp;the current &nbsp;settings &nbsp;and &nbsp;recommend the &nbsp;best &nbsp;settings, thereby facilitating the &nbsp;changing &nbsp;of phototherapy &nbsp;settings &nbsp;without &nbsp;human intervention; <br> a battery and charging unit (201) that comprises a rechargeable battery; ( @@h3 )<br> a switch for powering the device on or off (103); ( @@h2 )<br> and a wireless connectivity facilitator (102) that facilitates the device (300) to provide &nbsp;feedback &nbsp;in &nbsp;real-time &nbsp;based &nbsp;on &nbsp;measured &nbsp;bilirubin &nbsp;concentration and &nbsp;&nbsp;body &nbsp;&nbsp;temperature &nbsp;&nbsp;to &nbsp;&nbsp;a &nbsp;central &nbsp;nursing &nbsp;&nbsp;station, a &nbsp;&nbsp;compatible phototherapy &nbsp;&nbsp;unit, &nbsp;&nbsp;an &nbsp;&nbsp;application &nbsp;&nbsp;on &nbsp;&nbsp;a handheld &nbsp;&nbsp;device and/or an application on a wearable device ( @@h2 ).</p>

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