WO2019070116A1

WO2019070116A1 - An intelligent system for automated diagnosis and treatment of neonatal jaundice

Info

Publication number: WO2019070116A1
Application number: PCT/MY2018/050066
Authority: WO
Inventors: A S M Mukter UZ ZAMAN; Hin Yong WONG; Ala RZK; Alborz EHTESHAM; Shamala MANIAM; Sim Jui OON; Erfan HAJIMOHAMMADHOSSEINMEMAR
Original assignee: Universiti Telekom Sdn. Bhd.
Priority date: 2017-10-02
Filing date: 2018-10-01
Publication date: 2019-04-11

Abstract

An intelligent system (100) for automated diagnosis and treatment of neonatal jaundice includes a flexible phototherapy garment (102) for wrapping around a non- ocular body area of an infant to evenly irradiate light energy in a desired wavelength region, an automated control and image processing means (104) for continuous, real- time monitoring, control, analysis and prediction of a progress level in a neonatal jaundice treatment and at least one power supply means (106) integrated into the flexible phototherapy garment (102) for enabling a continuous power supply to irradiate a controlled amount of light energy evenly onto the body of the infant. The automated control and image processing means (104) performs continuous monitoring and control of the irradiated light energy in the desired wavelength region by the flexible phototherapy garment (102), comfortably wrapped around the non-ocular area of the body of the infant, and predicts the progress level in the neonatal jaundice treatment.

Description

AN INTELLIGENT SYSTEM FOR AUTOMATED DIAGNOSIS AND TREATMENT OF NEONATAL JAUNDICE

FIELD OF INVENTION

The invention generally relates to the treatment of neonatal hyperbilirubinemia or otherwise known as jaundice. In particular, the present invention relates to a system and a phototherapy device for automated diagnosis and treatment of neonatal jaundice.

BACKGROUND OF THE INVENTION

Approximately 60% of the millions of infants born around the world each year become clinically jaundiced. Jaundice, or hyperbilirubinemia, results from increased production and transiently impaired elimination of the pigment bilirubin. While most affected neonates recover rapidly, some infants show persistent high levels of unconjugated bilirubin. Such high levels can lead to kernicterus, a condition involving deposition of bilirubin in the brain, which leads to deficits in cognition, neuromuscular tone and control, and hearing, and even death. The most common therapy for neonatal hyperbilirubinemia is phototherapy. It is estimated that as many as hundreds of thousands of neonates in around the world receive phototherapy every year. Phototherapy facilitates the transformation of unconjugated bilirubin to compounds that are more easily excreted. Bilirubin undergoes three reactions in parallel, which includes photooxidation, configurational isomerization, and structural isomerization. Structural isomerization is the predominant mechanism leading to bilirubin elimination from the bloodstream. Structural isomerization transforms bilirubin instantaneously and continuously into the more polar non-toxic pigment lumirubin, which is presumably the major bilirubin product excreted in newborns undergoing phototherapy. The effectiveness of a phototherapy treatment typically depends on the intensity of the light, the surface area of exposure to the light, and the percentage of the light spectrum comprising wavelengths effective for treatment of the disease or disorder. The wavelength range generally effective for facilitating bilirubin photoisomerization is approximately 400-550 nm (violet to green), with light of a wavelength between 450 and 460 nm (blue) yielding maximal photoisomerization.

Phototherapy for treating hyperbilirubinemia is commonly delivered using fluorescent lamps suspended above the neonate. However, these conventional phototherapy devices have substantial drawbacks. While fluorescent lamps output high-intensity light, they also generate significant heat caused by infrared radiation, which prevents their placement close to the infant, thereby decreasing the irradiance. Fluorescent light is of a broad spectral range, and cannot be produced in only the narrow wavelength range desired. Conventional phototherapy devices typically illuminate the newborn only from above, leaving the skin at the back portion of the infant untreated, and do not therefore make optimal use of the available skin area. Furthermore, the use of fluorescent lamps for phototherapy leads to adverse side effects in many newborns. Such side effects include increased insensible water loss, hypothermia, loose and frequent bowel movements, tanning, and potential nasal obstruction by the eye pads required for preventing retinal damage. Furthermore, there are concerns that phototherapy using fluorescent lamps has potentially harmful effects on biological rhythms, and may increase the incidence of skin cancer in neonates subject to repeated treatment. Another problem is that many infants, particularly premature infants also receiving other treatments such as nasal CPAP, are often restless during the phototherapy process and do not lay still. This causes undue stress on the infant, and can lead to increase respiratory and heart rates, increase energy expenditure, over-heating, and discomfort. A simple technique used in the nursery to calm irritable infants is swaddling, which is a method of snugly wrapping the infant in a blanket. The snug wrap comforts and quiets the infant without the need for medication. However, swaddling is not currently an option in infants undergoing a course of phototherapy because the blankets currently used would block most or all of the phototherapy light from reaching the infant's skin, rendering the phototherapy procedure ineffective.

The recent advancements in flexible electronic circuitry and fiber optics led to development and use of flexible light emitting diode circuits that can be incorporated into the clothing of the infants for phototherapy treatment. The emission wavelength from the flexible light emitting diode circuits can be configured to fall within the 450 and 460 nm i.e. blue lights, yielding maximal photoisomerization. There are several prior arts, which disclose similar phototherapy devices, employing blue light radiating LED circuits incorporated into the clothing of the infant. However, most of the disclosed systems, methods and devices are not portable, requiring the baby to remain in one location. In addition, the disclosed systems, devices and methods often causes discomfort to the infants as they may be undergoing other treatment procedures causing restlessness, hence won't be able to stay still to receive the blue light evenly throughout the skin of the infant. The following prior arts disclose the different methods and devices used for the phototherapy treatment of the infant.

US 6596016 B l titled "Phototherapy of jaundiced newborns using garments containing semiconductor light-emitting devices", issued to Leland Stanford Junior University, discloses a phototherapy garment that contains a flexible backing material, a transparent liner, and a flexible printed circuit sheet containing surface-mounted light-emitting diodes (LEDs) positioned between the backing material and the liner. An infant is placed inside the garment so that the LEDs illuminate a large portion of the infant's skin for phototherapy. The LEDs preferably emit high-intensity blue light, suitable for treatment of neonatal hyperbilirubinemia or Crigler-Najjar syndrome. The LEDs are arranged in a densely packed array facing the liner and emit uniform, high intensity light. A portable power supply supplies adjustable power to the LEDs. A two-way communications device incorporated into the garment allows a physician or computer to control the garment remotely and gather relevant information periodically or continuously. The garment also contains a feedback system with skin bilirubin sensors (142), so that the intensity level and duration of light therapy can be based on bilirubin in the skin. However, the above disclosed phototherapy garment and system doesn't disclose a means for enabling true portability of the infant wrapped in the phototherapy garment as the handler needs to carry the infant along with the power supply means, which is often heavy and need to connected or recharged regularly for ensuring the continuous operation of the device. Moreover, the system doesn't disclose an intelligent processing means for predicting the effectiveness or a progress level of the treatment just by continuously analyzing the images of the infant during the treatment stages. Furthermore the system doesn't include an alerting means to alert relevant personal through their electronic devices such as smart wearable devices or other smart electronic devices of the users in real-time.

There is still a need, therefore, for a phototherapy device that provides high irradiance to a large surface area of the neonate, is inexpensive, consumes relatively low power, can be used outside of a hospital, minimizes discomfort to the neonate and caregivers, operates at the desired wavelength range, and is completely safe for the neonate. Moreover, there exists a need for an improved system, phototherapy device and method for real-time, continuous treatment and accurate prediction of the progress level of the phototherapy treatment. Furthermore, the needed system would allow the authorized users to view the progress level through a dynamic graphical user interface of an application launched from their electronic devices. Moreover, the needed phototherapy garment should enable equal distribution of the light of desired wavelength throughout the skin of the infant, in the non-ocular area, without causing discomfort and considerably limiting the movement of the body parts of the infant.

SUMMARY OF INVENTION The present invention relates to an intelligent system and a flexible phototherapy garment for automated diagnosis and treatment of a variety of diseases including neonatal jaundice. The intelligent system may include the flexible phototherapy garment for wrapping around a body of an infant to irradiate light energy of desired wavelength to the skin, at the non-ocular area, of the infant. The flexible phototherapy garment covers from a neck area to a toe area of the body of the infant enabling a controlled movement of the body parts such as the arms and legs of the infant. The intelligent system may further include an automated image processing means for realtime image capturing, analysis and prediction of a progress level in a jaundice treatment of the infant. The intelligent system may include an application having a dynamic graphical user interface capable of being launched from a central computer or an electronic device of an authorized user for continuous real-time monitoring and control of the progress level of the jaundice treatment. Furthermore, the application would provide real-time alerts and notifications regarding a number of events such as the effectiveness of the treatment, discomfort to the infant, and other parameters. Another important feature of the present system is the use of regenerative power supply incorporated into the flexible phototherapy garment in form of solar power, piezoelectric power generation or wireless or radio frequency based power generation means. This allows the infants to be carried away at home and to any desired location during the treatment and at the same time maintaining real-time monitoring and control of the phototherapy treatment.

In one implementation of the present flexible phototherapy garment, a number of light emitting diodes and/or flexible fiber optics lines is evenly distributed on an interior surface of the garment. The flexible light emitting diodes and/or flexible fiber optics lines on the inner surface of the garment are configured to irradiate light energy of desired wavelength, preferably in the blue light region, continuously and evenly onto the skin of the infant, at the non-ocular region. The flexible phototherapy garment can be sued to cover from the neck area to the toe area of the infant, providing a controlled movement to the arms and legs of the infant, thereby providing comfort and convenience during the phototherapy treatment. The flexible phototherapy garment is also provided with a connected means and a releasable closing means for easily wrapping the infant and engaging or disengaging the LED circuitry or the laser- fiber optics circuitry in the garment. In addition, the flexible phototherapy garment also incorporates regenerative or renewable power mechanisms as discussed above. The automated image processing means or the application running the electronic device of the users or at a treatment facility can be utilized to scan the eyes or the iris of the infant to determine an effectiveness or progress in the treatment.

In a further implementation, a method is provided using a flexible phototherapy garment, an automated image processing means or the application running on an electronic device of a user and/or a treatment facility for automated diagnosis and treatment of a variety of diseases including neonatal jaundice. The method may includes the steps of providing the flexible phototherapy garment having a number of flexible LEDs and/or fiber optics with associated flexible circuits evenly distributed on an inner surface of the garment. A power supply means is incorporated into the phototherapy garment, to power the flexible LEDs and/or fiber optics integrated into the flexible phototherapy garment, either chargeable using solar or piezoelectric or radio frequency means or from an external source. In the next step, the infant is placed on the flexible phototherapy garment and wrapped around from the neck to the toe region, allowing the controlled movement of the legs and arms of the infant. Once the infant is wrapped, the connector means and the releasable closing means can be engaged to start the phototherapy treatment. Then the eyes of the infant can be continuously scanned or monitored using video or image capturing methods utilizing the automated image processing means. The application running the electronic devices of the users or at a treatment facility can be utilized to scan the eyes or the iris of the infant to determine an effectiveness or progress in the treatment. The application provides a real-time dynamic view of the progress level of the phototherapy treatment through a dynamic graphical user interface. Furthermore, the application provides real-time updates and notifications regarding the progress of the treatment and predicts or schedules the optimal treatment duration and intensity of the radiation.

Other main features of the present system are discussed below. The present invention is designed to fulfill the below and other additional features as detailed in the following claims section and detailed description section of the invention.

A primary feature of the invention is to provide an intelligent system for automated diagnosis and treatment of a plurality of diseases including neonatal jaundice.

Another feature of the invention is to provide an intelligent system having a flexible phototherapy garment for providing phototherapy treatment to the non-ocular body of the infant.

Another feature of the invention is to provide an intelligent system having a flexible phototherapy garment with integrated flexible light emitting diode and fiber optics circuitry capable of evenly distributing blue lights of desired frequency to the skin of the infant.

Another feature of the invention is to provide a flexible phototherapy garment capable of comfortably wrapping around the body of the infant, enabling controlled movement of the body parts of the infant.

Another feature of the invention is to provide an intelligent system having a portable flexible phototherapy garment for automated diagnosis and treatment of neonatal jaundice.

Another feature of the invention is to provide an intelligent system having an automated image processing means for real-time image capturing, analysis and prediction of a progress level in a neonatal jaundice treatment of the infant.

Another feature of the invention is to provide an intelligent system having an automated image processing means capable of providing real-time alerts and notifications regarding the progress level in a neonatal jaundice treatment of the infant to a remote electronic device of a user.

Another feature of the invention is to provide an intelligent system having an automated image processing means with iris scanning for determining the progress level in a neonatal jaundice treatment of the infant to a remote electronic device of a user.

Another feature of the invention is to provide an intelligent system having a dynamic graphical user interface for displaying a real-time dynamic graphical view of the progress level in a neonatal jaundice treatment of the infant.

Another feature of the invention is to provide a flexible phototherapy garment having integrated regenerative power supply means for continuous neonatal jaundice treatment of the infant. The present invention that consists of features and a combination of parts are hereinafter fully described and illustrated in the accompanying drawings. It is being understood that various changes in the details may be made without departing from the scope of the invention or sacrificing any of the advantages of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of some embodiments of the present invention, a more particular description of the invention will be rendered by references to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the accompanying drawings in which:

Figure 1 shows an intelligent system for automated diagnosis and treatment of a number of of diseases including neonatal hyperbilirubinemia or jaundice in infants, according to a preferred embodiment of the present invention.

Figure 2a illustrates a flexible phototherapy garment with the lighting arrangements, according to one or more embodiment of the present invention.

Figure 2b is a block diagram showing a number of components integrated into the flexible phototherapy garment, according to a preferred embodiment of the present invention. Figure 3 shows a block diagram of the automated control and image processing means for real-time continuous monitoring, control, real-time image capturing, analysis and determination of a real-time and future progress level in the neonatal jaundice treatment, according to a preferred embodiment of the present invention.

Figure 4 shows a block diagram of the power supply means integrated into the flexible phototherapy garment for enabling a continuous power supply to irradiate a controlled amount of light energy of predetermined wavelength evenly onto the body of the infant, according to an embodiment of the present invention.

Figure 5a to Figure 5g discloses a method of comfortably wrapping the infant using the flexible phototherapy garment, according to a preferred embodiment of the present invention.

Figures 6a and 6b shows the infant comfortably wrapped using the flexible phototherapy garment placed on a fiber optic pad and on a baby nest bed, according to an embodiment of the present invention.

Figure 7 is a flowchart showing the sequence of operation of the present intelligent system, according one or more embodiment of the present invention. Figure 8 is a flowchart showing a number of processing steps for analysis, autonomous control and for predicting a progress level in the neonatal jaundice treatment, according to one or more embodiment of the present invention. Figure 9 is a flowchart showing a number of steps associated with a method for automated diagnosis and treatment of a number of diseases including neonatal jaundice, according to one or more embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to an intelligent integrated system for automated diagnosis and treatment of a variety of diseases including neonatal hyperbilirubinemia or jaundice, according to one or more embodiment of the present invention. The present system includes a comfortable flexible garment with flexible lighting arrangements that can be used to wrap around the body of the infant, without covering the facial part of the infant, to irradiate light energy of desired wavelength for a desired duration of time. The present intelligent integrated system further includes an automated controlling means for automatically monitoring and thereby controlling the amount of light energy irradiated onto the skin of the infant. The flexible phototherapy garment is portable, easily wearable or wrappable around the body of the infant, lightweight, and is continuously powered using portable regenerative or easily renewable power supply means. The flexible phototherapy garment is either incorporated with light emitting diodes, LED, capable of delivering light of desired wavelength and intensity or with other flexible fiber optics or laser based fiber optics or a combination of any of the above. These LEDs and/or the laser-based fiber optics are placed in the interior surface of the flexible phototherapy garment, without causing discomfort to the infant, for irradiating the light energy of desired wavelength in the pre- selected wavelength region and intensity directly onto the skin of the infant. The flexible phototherapy garment offers comfort and equally distributes the light of a particular wavelength or within a particular wavelength region from the LEDs and/or the laser-based fiber optics embedded into the phototherapy garment without causing discomfort to the infant. The present system and the comfortable flexible phototherapy garment help to reduce the bilirubin levels in the body of the infant at a faster rate. In addition, the present system enables continuous monitoring of the bilirubin levels and a progress and effectiveness in the phototherapy treatment using lightweight portable electronic devices and automatically controls the intensity and the duration of radiation by analyzing the reference, past and real-time images of the face and the eyes of the infant. The present system also acts as an alerting or notification tool for alerting the medical and other authorized personnel, in real-time or in advance, in case of any emergencies.

In one or more implementation of the present system, the light-emitting diodes (LEDs) integrated into the interior of the comfortable flexible phototherapy garment to deliver light directly to the skin of the infant are small, durable, long-lasting, generating less heat, has high efficiency and are connected using a flexible circuit. In some other instances, the LEDs used in the flexible phototherapy garment are chip- LEDs that offer less heat generation with high-energy output and high efficiency. This results in comfortable, flexible, portable, lightweight, easy to use, and relatively inexpensive phototherapy garment. In some other implementations of the present system, the light of desired wavelength are more directed to certain areas of the body where there are substantial blood vessels near the surface of the skin, the vascular tissue regions, so that the light can interact with photoactive substances in the blood to correct various problems. In such an implementation, the phototherapy garment consists of more LEDs near specific areas to irradiate the light of desired wavelength towards the area behind the knee joint, chest, neck, arm and abdominal area of the infant. However, in most of the implementations of the resent system, the LEDs or the laser fiber optics are arranged inside the garment to evenly distribute the light of desired wavelength throughout the surface or skin of the infant, in the non-ocular region. In all the above implementations, the automated control and processing means for analyzing the present state and the progress level of the treatment and for predicting the future result or future progress level is more or less the same.

Figure 1 shows an intelligent system (100) for automated diagnosis and treatment of a number of of diseases including neonatal hyperbilirubinemia or jaundice in infants, according to a preferred embodiment of the present invention. The present intelligent system (100) for automated diagnosis and treatment of neonatal jaundice mainly includes a flexible phototherapy garment (102) for comfortably wrapping around the body of an infant to continuously and evenly irradiate light energy of desired wavelength or light energy in a desired region of the wavelength for a desired or predetermined duration to reduce the bilirubin levels in the body of the infant to acceptable levels, according to a preferred embodiment of the present invention. The flexible phototherapy garment (102) includes a number of lighting arrangements (114) evenly distributed on an inner surface (116) to irradiate the light energy in the selected wavelength, such as 450 - 460 nm wavelength in the blue light region, to the skin of the infant. In some embodiment, the lighting arrangements (114) provided in the flexible phototherapy garment (102) includes a number of LEDs, such as chip-type LEDs, offering high intensity light radiation with minimal heat generation. In some other embodiment, the lighting arrangements (114) provided in the flexible phototherapy garment (102) include a number of laser fiber optic lines distributed throughout the inner surface (116) of the garment (102). In some instances, the lighting arrangements (114) provided in the flexible phototherapy garment (102) include a combination of LEDs and laser fiber optic lines connected using flexible circuitry. In all the above cases, the lighting arrangements (114) are properly distributed or integrated into the flexible phototherapy garment (102) to irradiate light of predetermined wavelength, within 450 - 460 nm, without causing discomfort to the infant.

The present intelligent system (100) further includes an automated control and image processing means (104) for real-time continuous monitoring, analysis and prediction of a progress level in a neonatal jaundice treatment. In some instances, the automated control and image processing means (104) is a computer system or an image processing system having a processor and associated electronic circuitry for receiving, storing and processing a variety of data including a number images of the infant captured using an image capturing means. The automated control and image processing means (104) includes an application having a number of instructions capable of executed using the processor to provide real-time updates, a number of alerts and other information regarding the progress level of the neonatal jaundice treatment and a future treatment result or future progress level or expected progress level of the neonatal jaundice treatment, according to one or more embodiment of the present invention. The automated control and image processing means (104) further includes a communication module or an interface means to communicate with an control the irradiation from the lighting arrangements (114) or the LEDs in the flexible phototherapy garment (102) wrapping the infant over a wired or wireless communication channel. The present intelligent system (100) further includes a power supply means (106), provided as an integral part of the flexible phototherapy garment (102), to power a number of operations including continuously powering the lighting arrangements (114) to irradiate a controlled amount of light energy evenly onto the body of the infant for a predetermined duration. In addition, the present intelligent system (100) may include means that is capable to do self-calibration. For example, the system can measure the intensity of the light and can compare with the predefined value. If it find the intensity is out of limit, it can trigger an alarm or can send an alert message.

Figure 2a illustrates the flexible phototherapy garment (102) with the lighting arrangements (114) and Figure 2b is a block diagram showing a number of components integrated into the flexible phototherapy garment (102), according to a preferred embodiment of the present invention. The flexible phototherapy garment (102) shown in Figure 2a is made from a comfortably flexible material made from fabrics such as wool, cotton or any other material clothing material or a combination of the material in different layers. In one or more embodiment of the present invention, the shape of the flexible phototherapy garment (102) is specially designed to completely wrap the non-ocular region of the body of the infant. In a preferred embodiment, the flexible phototherapy garment (102) covers from a neck area to the toe area of the infant, comfortably covering the arms and legs allowing a controlled or limited movement. In some other instances, the flexible phototherapy garment (102) is made in form of a jacket or other type of clothing for completely covering the non- ocular region of the body of the infant. In some other instance, the flexible phototherapy garment (102) is provided as a piece of clothing with integrated lighting arrangements (114) within an inner layer of the garment delivering light to the skin of the infant through certain small openings aligned with each of the lighting arrangements (114). In another embodiment, a transparent, heat insulating clothing layer covers the integrated lighting arrangements (114) provided within the inner layer of the garment to prevent direct heat transfer from the lighting arrangements (114) such as the LEDs to the skin of the infant. In one or more instances, the flexible phototherapy garment (102) is provided in form a price of clothing with a base portion (110) having a top edge, a bottom edge and a pair of side edges for covering a back area of the body of the infant, a top portion (118) continuously extending from the bottom edge of the base portion (110) to cover a non-ocular front area of the body of the infant and a pair of extending side portions (112a, 112b) extending out from the pair of side edges of the base potion (110) to cover a left side body part and a right side body part of the infant. The lighting arrangements (114) such as the LEDs and the laser-based fiber optics are evenly distributed on an inner surface (116) of the base portion (110), the top portion (118) and the pair of extending side portions (112a, 112b) to deliver equal amount of light energy of a predetermined wavelength to the skin of the infant wrapped using the flexible phototherapy garment (102). The pair of extending side portions (112a, 112b) of the flexible phototherapy garment (102) is also provided with a connector means (120) and a releasable closing means (122) to secure the flexible phototherapy garment (102) wrapped around the body of the infant.

The lighting arrangements (114) such as the LEDs and the laser-based fiber optics are evenly distributed on the inner surface (116) of the flexible phototherapy garment (102) and connected using flexible circuitry A portable power supply means (106) is integrated into the flexible phototherapy garment (102) for enabling a continuous power supply to irradiate a controlled amount of light energy of a predetermined wavelength evenly onto the skin at the non-ocular area of the infant. In certain embodiment, when the connector means (120) attached to the pair of extending side portions (112a, 112b) is engaged after wrapping the infant with the flexible phototherapy garment (102), the power supply to the lighting arrangements (114) provided on the inner surface of the flexible phototherapy garment (102) is activated. The releasable closing means (122) provided on the pair of extending side portions (112a, 112b) of the flexible phototherapy garment (102) includes attachment means such as, but not limited to, Velcro, pins or any other attaching means to secure the wrapped up position of the flexible phototherapy garment (102) around the body of the infant. In some instances, the flexible phototherapy garment (102) further includes one or more sensors (142) for measuring a number of parameters including temperature, bilirubin level in the infant etc., a controller (108) for controlling a light output from the lighting arrangements (114), and a communication device (144) for enabling wired and/or wireless communication of the controller (108) with a number of external devices for automated or remote controlled operation of the LEDs (114) for generating light of predetermined wavelength to irradiate onto the skin of the infant. With all the integrated components, the flexible phototherapy garment (102) is made lightweight, portable, comfortable and easily handled and operated by anyone just by wrapping and engaging the connector means (120) and the releasable closing means (122) to start the phototherapy treatment. Figure 3 shows a block diagram of the automated control and image processing means (104) for real-time continuous monitoring, real-time image capturing, analysis and determination of a progress level in the neonatal jaundice treatment and for predicting a progress level or treatment result in the neonatal jaundice treatment based on past, real-time and reference image data such as from the images of the eyes and the face of the infant, according to a preferred embodiment of the present invention. In one or more embodiment, the automated control and image processing means (104) is a computer system having a processor (126) for processing a number of instructions of an application for automated diagnosis, control and treatment of neonatal jaundice, one or more camera module (130) for capturing one or more real-time image and/or a video of an eye or iris and/or a skin of the infant, a display means (132) for displaying a variety of real-time updates and alerts regarding the progress level of the neonatal jaundice treatment to a number of users and a communication module (132) for enabling communication with a number of external electronic communication devices (134) in real-time.

In some instances, the automated control and image processing means (104) is a smart electronic device (104) such as a smartphone or tablet or a computer or a wearable device or any other electronic device capable of running the application for automated diagnosis, control and treatment of neonatal jaundice with a number of processor executable instructions. The smart electronic device (104) of the users can download the application from an application store and install and run the application. The users of the application is provided with unique authorization credentials and are allowed to manage a plurality of information including the images of the infant, schedule the light irradiation process, control intensity and wavelength of the light energy etc. Further the camera module (130) of the smart electronic device (104) of the users can be utilized for for capturing the real-time images and/or the video of the eye or iris and/or the face of the infant. The capture images or video can be processed in the processor (126) of the smart electronic device (104) based on the instructions of the application stored in a storage unit (136). A memory unit (138) temporarily stores the instructions of the application and the captured image data during the processing of the instructions and the captured image data and other reference images stored in the storage unit (136). The communication module (132) associated with the smart electronic device (104) of the users enables communication with a number of external electronic communication devices (134) in real-time over a wireless communication network, such as, the networks established using third/fourth/fifth generation mobile communication technologies or other wireless communication means. In some other instances, the smart electronic device (104) of the users further includes an input- output means (140) to directly connect with an external connector outlet (124) provided on the flexible phototherapy garment (102) and other electronic devices for collecting, transferring and processing a variety of data related to the neonatal jaundice treatment.

The smart electronic device (104) performs all the processing and analysis operations in real-time and presents the results including the progress level of the neonatal jaundice treatment through the dynamic graphical user interface of the application displayed on the display means (130) of the device (104). Further, in some instances, the display means (130) of the smart electronic device (104) is a touchscreen display (132) allowing the users to interact with the contents displayed through the dynamic graphical user interface of the application. The touchscreen display means (132) of the smart electronic device (104) allows the users to control the exposure duration of the light energy, intensity of the light energy etc., based on the information displayed through the dynamic graphical user interface of the application. In some other embodiment, the automated control and image processing means (104) or the smart electronic device (104) enables complete autonomous control of the neonatal jaundice treatment, including the control the exposure duration of the light energy, intensity of the light energy etc. based on the real-time data received by processing the images of the face and eye of the infant, stored reference images, and the past images of the infant collected during a particular period of time.

Figure 4 shows a block diagram of the power supply means (106) integrated into the flexible phototherapy garment (102) for enabling a continuous power supply to irradiate a controlled amount of light energy of predetermined wavelength evenly onto the body of the infant, according to an embodiment of the present invention. In a preferred embodiment of the present invention, the power supply means (106) integrated into the flexible phototherapy garment (102) includes at least one renewable power generating means selected from a group consisting of solar, piezoelectric and radio frequency, RF, power generation. The power supply means (106) includes similar components as that of a renewable power supply system, which includes a DC-DC converter, a super capacitor or power bank or rechargeable batteries, and other control and protection circuits. In a preferred embodiment, the power supply to the lighting arrangements (114) or LEDs (114) are initiated when the connector means (120) provided on the pair of extending side portions (112a, 112b) or the inner surface of the flexible phototherapy garment (102) is engaged after comfortably wrapping the infant therewithin.

In some other embodiment, the energy for the operations of the lighting arrangements (114) or LEDs (114) and other control circuitry are supplied by a main energy source. The power from the main energy source undergoes DC-DC converter if the source or the main energy source is more or less than recommended energy supply for the lighting arrangements (114). The power supply means (106) includes super capacitors or power banks or rechargeable batteries integrated into the flexible phototherapy garment (102). In the power circuit associated with the power supply means (106), a charge protection and also revised bias protection is provided to protect the batteries from getting over charged. The battery will autonomously stop from charging once the storage is full. This power supply means (106) includes an energy harvester where the battery can be charged by hybrid energy such as solar, piezoelectric and also RF by source converter. The operation of the present intelligent system (100) for automated diagnosis and treatment of neonatal jaundice are described in the following steps. Figure 5a to Figure 5g discloses a method of comfortably wrapping the infant using the flexible phototherapy garment (102), according to a preferred embodiment of the present invention. Figure 5a shows the stretched out view of the inner surface (116) of the flexible phototherapy garment (102). Figure 5c shows the wiring or electric connections, connecting the lighting arrangements (114) or the LEDs or the laser based fiber optics, running underneath the inner surface (116) of the flexible phototherapy garment (102). In one or more embodiment, the lighting arrangements (114) or the LEDs or the laser based fiber optics are arranged beneath a transparent and comfortable inner layer of the flexible phototherapy garment (102). In some other embodiment, the inner surface (116) of the flexible phototherapy garment (102) includes openings at specific locations of the lighting arrangements (114) or the LEDs or the laser based fiber optics for effectively irradiating the light energy of predetermined wavelength to the skin of the infant. Figure 5a and Figure 5b shows the base portion (110) having the top edge, bottom edge and the pair of side edges for covering the back area of the body of the infant. The top portion (118) of the flexible phototherapy garment (102) continuously extends from the bottom edge of the base portion (110) to cover a non-ocular front area of the body of the infant and the pair of extending side portions (112a, 112b) extends out from the pair of side edges of the base potion (110) to cover the left side body part and the right side body part of the infant. The lighting arrangements (114) such as the LEDs and the laser-based fiber optics are evenly distributed on an inner surface (116) of the base portion (110), the top portion (118) and the pair of extending side portions (112a, 112b) to deliver equal amount of light energy of a predetermined wavelength to the skin of the infant wrapped using the flexible phototherapy garment (102). Figure 5c shows the external connector means (124) for enabling the flexible phototherapy garment (102) to connect with the external devices such as a computer or an external LED controller or an external main power supply, according to one or more embodiment of the present invention.

Figure 5c further shows the lighting arrangements (114) such as the LEDs and associated electric connections provided on the inner surface (116) of the flexible phototherapy garment (102) for providing the predetermined amount of light energy of predetermined wavelength to the skin of the infant, continuously for a predetermined duration of time. As described in the previous paragraphs, the lighting arrangements (114) such as the LEDs are connected using flexible connecting means are comfortably placed on the inner surface (116) of the flexible phototherapy garment (102). In some instances, the lighting arrangements (114) such as the LEDs are placed beneath a transparent layer of comfortable clothing or incorporated into a clothing layer having a number of openings at specific locations for exposing the lighting arrangements (114) such as the LEDs to deliver the light energy of desired intensity to the skin of the infant. In some instances, the lighting arrangements (114) such as the LEDs used is a chip-LED capable of delivering the light energy of predetermined wavelength and intensity without causing heating effect on the skin of the infant. In some other embodiment, the flexible phototherapy garment (102) is made from comfortable, breathable, lightweight and flexible fabric to provide comfort to the infant while performing the neonatal jaundice treatment. Figure 5d shows the method of placing the infant on the base portion (110) of the flexible phototherapy garment (102), keeping the head of the infant outside the top edge of the base portion (110). The other body parts of the infant are comfortably kept within the inner surface (116) of the flexible phototherapy garment (102).

Once the infant is placed on the base portion (110) of the flexible phototherapy garment (102), as in Figure 5e, the top portion (118) of the flexible phototherapy garment (102) is folded over to cover the front body or skin of the infant. The folded top portion (118) over the front body area of the infant provides comfortable placement of the arms and legs of the infant and allows a limited or controlled movement, thereby allowing improved comfort to the infant. Now as in, Figure 5f, the pair of extending side portions (112a, 112b) comfortably covers the side portions of the body of the infant to irradiate light energy of the predetermined wavelength and intensity to the skin area at the side body parts of the infant. The connector means (120) and the releasable closing means (122) provided on the pair of extending side portions (112a, 112b) can be used to comfortably secure the flexible phototherapy garment (102) around the body of the infant. Figure 5g shows the infant comfortably wrapped using the flexible phototherapy garment (102) for irradiating light energy of predetermined wavelength, such as in the blue light region, and predetermined intensity onto the skin of the infant. The infant comfortably wrapped using the flexible phototherapy garment (102) can be carried by the caretakers to any desired location and can be placed on a level surface or in a crib or a baby nest bed or a blanket as desired, as in Figures 6a and 6b. In one or more embodiment, the present intelligent system (100) includes a sensor device (142) for continuously or periodically scanning the infants' iris and face and then record those into the storage unit of the electronic device (128).

The automated control and image processing means (104) of the present intelligent system (100) can be used to irradiate light energy of predetermined wavelength and intensity onto the skin of the infant, after comfortably wrapping the infant using the flexible phototherapy garment (102). An authorized user can launch the application for automated diagnosis, control and treatment of neonatal jaundice from the electronic device (128), which can be a standalone device or an electronic communication device (128) of the user configured to operate the present intelligent system (100) including the light output from the lighting arrangements (114) such as the LEDs provided in the flexible phototherapy garment (102). Figure 7 is a flowchart showing the sequence of operation of the present intelligent system (100), according one or more embodiment of the present invention. The authorized users can login to the application for automated diagnosis, control and treatment of neonatal jaundice from the electronic device (128) of the user or from a dedicated electronic device provided at the treatment facility. A server in communication with a number of electronic devices running the application including the electronic device (128) of the user authenticates the user based on pre-allocated unique user credentials. Further, the dynamic graphical user interface of the application allows the users to select a phototherapy dosage or intensity of the phototherapy light energy emitted from the lighting arrangements (114) such as the LEDs provided within the flexible phototherapy garment (102) and the duration of the phototherapy based on a medical condition of the infant. The dynamic graphical user interface of the application also includes options for saving the selected values of duration and the phototherapy dosage into the memory unit (138) of the electronic device (128). The users can key in the light intensity and the period of irradiation required for treating jaundice through the touchscreen display means (132) of the electronic device (128) or through the input-output means (138) such as a keyboard. The dynamic graphical user interface of the application also allows the users to set the period or duration for the phototherapy to be turned on and off autonomously by analyzing the progress level of the jaundice treatment. The dynamic graphical user interface of the application notifies the user if the phototherapy electronic device (128) is not connected correctly to the flexible phototherapy garment (102) and also creates an audible alert to inform the users to turn down the light output from the lighting arrangements (114) such as the LEDs provided within the flexible phototherapy garment (102). According to another embodiment of the present invention, the dynamic graphical user interface of the application running on the electronic device (128) allows the users to track the progress of the jaundice treatment from any remote location and to receive alerts and notifications regarding the jaundice treatment of the infant in real- time. The electronic device (128) of the users can be their personal smart electronic devices such as smartphones, tablets or wearable devices running the present application. The dynamic graphical user interface of the application further enables the users to remotely initiate and control of the irradiated light energy in a desired or predetermined wavelength region from the lighting arrangements (114) such as the LEDs provided within the flexible phototherapy garment (102), set a desired or pre- calculated duration for evenly distributing the irradiated light energy to the skin of the infant, and to start processing of a variety of information including the reference images, a number of past images of the eyes and face of the infant and a number of real-time images of the face and eyes of the infant and receive a dynamic visualization of the real-time progress level of the neonatal jaundice treatment. The dynamic graphical user interface of the application also provides a predicted progress level of the neonatal jaundice treatment by analyzing the variety of information including the reference images, the number of past images of the eyes and face of the infant and the real-time images of the face and eyes of the infant.

Figure 8 is a flowchart showing a number of processing steps for analysis, autonomous control and for predicting a progress level in the neonatal jaundice treatment, according to one or more embodiment of the present invention. The storage unit (130) of the electronic device (128) stores a number of reference images showing the face and eyes of infants without the neonatal jaundice. The sensor (142) provided with the present system (100) or the camera module (130) of the electronic device (128) can be used to capture the image of the eyes and face of the infant in real-time. The captured images are stored in the storage unit (130) and then compared with the reference images based on the instructions of the application. If the real-time images of the eyes and face of the infant shows a reduction in the bilirubin levels, based on the reference images and the past images of the infant, during the treatment, stored in the storage unit (130), then the progress level of the jaundice treatment is displayed to the user through the dynamic graphical user interface of the application. If the bilirubin levels are above a certain level and doesn't show any indication of reduction, then the authorized personnel are alerted and notified with preset messages such as "Consult Doctor as soon as possible". If the bilirubin levels are within acceptable levels of a normal infant without jaundice, then the authorized personnel are notified and the irradiation of light energy from the lighting arrangements (114) are automatically stopped or alerts the authorized users to stop the radiation. The application also predicts the future progress level and the intensity and duration of the phototherapy treatment required for achieving the desired result based on the reference images, the past images stored in the storage unit (130) of the electronic device (128) and the real-time images of the face and eyes of the infant received by the electronic device (128) and provides suitable preset notifications such as "Baby is getting better" to the caretakers through the application. Based on the above processing steps, the present application can be utilized to automatically control the intensity and the duration of irradiance of the light energy to achieve optimal results.

Figure 9 is a flowchart showing a number of steps associated with a method for automated diagnosis and treatment of a number of diseases including neonatal jaundice, according to one or more embodiment of the present invention. The method starts with the step of providing the flexible phototherapy garment (102) having a number of lighting arrangements (114) evenly distributed on the inner surface (116) of the flexible phototherapy garment (102), as in block 200. The flexible phototherapy garment (102) can be used to comfortably wrap the non-ocular area of the body of the infant as in block 202. The connector means (120) and the releasable closing means (122) provided with the flexible phototherapy garment (102) helps to secure the flexible phototherapy garment (102) comfortably wrapped around the body of the infant. Now as in block 204, the automated control and image processing means (104) can be used to start irradiating a controlled amount of light energy in a predetermined wavelength region evenly onto the body of the infant for a predetermined duration. A number of sensors (142) or the camera module (130) of the automated control and image processing means (104) can be used to continuously monitoring the face and the eyes of the infant, as in block 206, to obtain a progress level of the neonatal jaundice treatment in real-time. The collected images are sent to the application running on the automated control and image processing means (104) for further processing along with other information including a number of reference images, a number of past images of the eyes and face of the infant captured during the treatment to predict a progress level of the neonatal jaundice treatment, as in block 208. Then the predicted neonatal jaundice treatment progress level is dynamically presented through the dynamical graphical user interface of the application, as in block 210. Then as in block 212, a number of notifications and alerts related to the real-time progress level and the predicted neonatal jaundice treatment progress level of the infant are provided to the authorized users through their electronic devices (134) in real-time. Finally as in block 212, the dynamical graphical user interface of the application automatically controls the on and off operation lighting arrangements (114) or allows the authorized users to manually control the light intensity and the duration of phototherapy based on the information presented to them through the dynamical graphical user interface.

In some embodiment, the dynamical graphical user interface of the application running on the electronic device (128) of the users allows them to control the wavelength of the light energy generated from the LED or laser fiber optic lighting arrangements (114) provided within the flexible phototherapy garment (102). For obtaining optimum results during the neonatal jaundice treatment the wavelength of the light energy is set in the 450 - 460 nm blue light wavelength region. The automated control and image processing means (104) enables automated, continuous, real-time monitoring, control, diagnosis and treatment of neonatal jaundice. Moreover the automated control and image processing means (104) dynamically presents the real-time progress level and the predicted neonatal jaundice treatment information such as the desired progress level, time remaining for achieving a predetermined desired progress level, etc., in the neonatal jaundice treatment through the dynamical graphical user interface of the application. The present invention may be embodied in other specific forms without departing from its essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore indicated by the appended claims rather than by the foregoing description. All changes, which come within the meaning and range of equivalency of the claims, are to be embraced within their scope.

Claims

1. An intelligent system (100) for automated diagnosis and treatment of a plurality of diseases including neonatal jaundice comprising:

a flexible phototherapy garment (102) for wrapping around a body of an infant to evenly irradiate light energy in a desired wavelength region, wherein the flexible phototherapy garment (102) covers a non-ocular area of the body of the infant, enabling a controlled movement of a plurality of body parts of the infant;

an automated control and image processing means (104) for continuous, real-time monitoring, control, analysis and prediction of a progress level in a neonatal jaundice treatment; and

at least one power supply means (106) integrated into the flexible phototherapy garment (102) for enabling a continuous power supply to irradiate a controlled amount of light energy evenly onto the body of the infant.

characterized in that the automated control and image processing means (104) performs continuous monitoring and control of the irradiated light energy in the desired wavelength region by the flexible phototherapy garment (102), comfortably wrapped around the non-ocular area of the body of the infant, and predicts the progress level in the neonatal jaundice treatment.

2. The intelligent system (100) according to claim 1, wherein the flexible phototherapy garment (102) for wrapping around the body of the infant includes:

a base portion (110) having a top edge, a bottom edge and a pair of side edges for covering a back area of the body of the infant;

a top portion (118) continuously extending from the bottom edge of the base portion (110) to cover a non-ocular front area of the body of the infant;

a pair of extending side portions (112a, 112b) extending out from the pair of side edges of the base potion (110) to cover a left side body part and a right side body part of the infant; a plurality of lighting arrangements (114) evenly distributed on an inner surface (116) of the base portion (110), the top portion (118) and the pair of extending side portions (112a, 112b); and

an external connector outlet (124) to receive power from an external energy source.

3. The intelligent system (100) according to claim 2, wherein the pair of extending side portions (112a, 112b) of the flexible phototherapy garment (102) is provided with a connector means (120) and a releasable closing means (122) to secure the flexible phototherapy garment (102) wrapped around the body of the infant,

wherein the connector means (120) further enables power supply to the plurality of lighting arrangements (114) provided on the inner surface of the flexible phototherapy garment (102).

4. The intelligent system (100) according to claim 2, wherein the plurality of lighting arrangements (114) includes a plurality of LED lights and a plurality of blue fiber optic lasers flexibly arranged on the inner surface of the flexible phototherapy garment (102),

wherein the plurality of lighting arrangements (114) evenly irradiates light energy of the desired wavelength region throughout the non-ocular area of the body of the infant.

5. The intelligent system (100) according to claim 1, wherein the automated control and image processing means (104) includes:

a processor (126) associated with at least one electronic device (128) capable of executing a plurality of instructions of an application for automated diagnosis, control and treatment of neonatal jaundice;

at least one camera module (130) for capturing at least one image and/or a video of an eye and/or a skin of the infant;

a display means (132) for displaying a plurality of real-time updates and a plurality of alerts regarding the progress level of the neonatal jaundice treatment to a plurality of users; and a communication module (132) for enabling communication with a plurality of external electronic communication devices (134) in realtime;

wherein the automated control and image processing means (104) enables continuous real-time remote monitoring of the progress level of the neonatal jaundice treatment through a dynamic graphical user interface of the application running on the electronic device (128).

6. The intelligent system (100) according to claim 5, wherein the dynamic graphical user interface of the application running on the electronic device (128) enables the users to:

initiate and control of the irradiated light energy in a desired wavelength region from the flexible phototherapy garment (102);

set a desired duration for evenly distributing the irradiated light energy to the skin of the infant;

start processing of a plurality of information including a plurality of reference images, a plurality of past images and a plurality of real-time images of a face including at least one eye of the infant; and receive a dynamic visualization of a real-time progress level of the neonatal jaundice treatment and a predicted neonatal jaundice treatment information; and

provide a plurality of alerts to a plurality of third parties through the plurality of external electronic communication devices (134) in realtime.

7. The intelligent system (100) according to claim 1, wherein the power supply means (106) integrated into the flexible phototherapy garment (102) includes at least one renewable power generating means selected from a group consisting of solar, piezoelectric and radio frequency power generation.

8. A method for automated diagnosis and treatment of a plurality of diseases including neonatal jaundice includes the steps of: providing a flexible phototherapy garment (102) having a plurality of lighting arrangements (114) evenly distributed on an inner surface (116); wrapping a non-ocular area of a body of an infant using the flexible phototherapy garment (102);

irradiating a controlled amount of light energy evenly onto the body of the infant for a neonatal jaundice treatment,

wherein an automated control and image processing means (104) controls the irradiated light energy in a desired wavelength region for a desired duration;

monitoring a face and at least one eye of the infant continuously to obtain a progress level of the neonatal jaundice treatment in real-time, wherein a real-time progress level of the neonatal jaundice treatment is dynamically presented through a dynamical graphical user interface of an application;

processing a plurality of information including a plurality of reference images, a plurality of past images and a plurality of real-time images of the face and the at least one eye of the infant to predict a neonatal jaundice treatment information,

wherein the predicted neonatal jaundice treatment information is dynamically presented through the dynamical graphical user interface of the application; and

providing a plurality of notifications and alerts related to the real-time progress level and the predicted neonatal jaundice treatment information through a plurality of external electronic communication devices (134) in real-time.

9. The method according to claim 8, wherein the plurality of lighting arrangements (114) on the inner surface (116) of the flexible phototherapy garment (102) evenly irradiates light energy in 450 - 460 nm blue light wavelength region.

10. The method according to claim 8, wherein the automated control and image processing means (104) enables automated continuous, real-time, remote, monitoring, control, diagnosis and treatment of neonatal jaundice.