DESC:RETROFIT NEONATAL CRITICAL CARE SYSTEM

Field of invention
The present invention relates to a neonatal critical care system and more particularly, the present invention relates to neonatal critical care system attached as a retrofit to existing baby warmer units in a hospital environment.
Background of the invention

Neonatal hypothermia occurs when a new-born’s body temperature drops below 36.5°C (97.7°F). A significant increase in neonatal mortality is associated with each 1°C reduction in the body temperature. Specifically, the loss of body heat can occur due to cold environments or failure to immediately dry and wrap the infant after birth. As the pre-term and low-birth-weight babies have smaller amounts of the fat that helps to generate heat, they are at greater risk for hypothermia.

Thermoregulation is a process that allows the body to maintain its core internal temperature. The entire thermoregulation mechanism is designed to return the body back to homeostasis. Thermoregulation in the neonate is a critical physiological function that is strongly influenced by physical immaturity, extent of illness, and environmental factors. The average normal axillary temperature is considered to be 37°C and normal temperature in neonates is about 36.4°C (97.5F).

Conventionally, radiant warmer, is a body warming device to provide heat to the body. This device helps to maintain the body temperature of the baby (neonate) and limit the metabolism rate. Heat has a tendency to flow in the heat gradient direction that is from high temperature to low temperature. The heat loss in some new born babies is rapid; hence body warmers provide an artificial support to keep the body temperature constant. In certain areas with very cold climate, babies are kept on the radiant warmer for couple of hours immediately after birth to ensure the baby is stabilized after birth.

In addition to this, there are some other vital parameters such as SPO2 level, heart rate, weight, pulse rate and the like need to be evaluated for a new borne baby in order to ensure healthy growth of the baby. These parameters have been evaluated by using a separate data capturing & monitoring device along with radiant warmer and the expert/trained personnel is needed to monitor and control all such devices and treat the baby as per the need.

However, in case of large hospital establishments, there might be neonatal critical care devices, however, their controlling and monitoring becomes a difficult task in case of lack of experts and time availability. For example, the baby may have different body temperature and different foot temperature due to some inherent issues with hospital neonatal care system. But, currently, there is no mechanism which identifies thus temperature difference and provides correct analysis of the health of the baby. Even if someone wants to adapt the measures to correct the inherent issues of the neonatal critical care units, the costs of existing baby warmer units doesn’t allow them to adapt to the changes. Further, in the current neonatal critical care units, the data has to be maintained manually and there is no access to that data to a doctor who is sitting in remote location.

Accordingly, there exists a need to provide a neonatal critical care system which overcomes above-mentioned drawbacks.

Object of the invention

An object of the present invention is to provide a retrofit neonatal critical care system.

Another object of the present invention is to provide a neonatal critical care system for thermoregulation for improved patient management, easy to operate with real time monitoring of vital parameters remotely.

Yet another object of present invention is to provide an integrated neonatal critical care system for thermoregulation to monitor heat regulation along with other vital parameters with minimizing need to handle a patient personally.

Summary of the invention

Accordingly, the present invention provides a retrofit neonatal critical care system capable of connecting to existing baby warmer units having a heater, cradle and pedestal. The neonatal critical care system comprises a plurality of temperature sensors which helps to provide predictive analysis of the baby condition selected from any one of fever onset, heat stress onset, cold onset by calculation of DeltaT. The system further comprises at least one thermoregulator operably connected to the plurality of temperature sensors for regulating load cycle of the heater of the baby warmer unit, a plurality of load cells configured within a base of the cradle for continuously monitoring weight of the baby, at least one input cum LCD display device operably connected to the cloud server to display, control and communicate data, the input cum LCD display device is configured to monitor and display vital parameters of the baby, a cloud server operably coupled to the plurality of temperature sensor, the plurality of load cells and the input cum LCD device, and
a central data processor operably coupled to plurality of temperature sensors, and the load cells, the cloud server and the input cum LCD display device. Specifically, the central data processer is configured to receive, communicate, and process received data. The central data processor is configured to calculate DeltaT from the data received from the plurality of temperature sensors to predict the current baby condition and trigger alarms if any of the sensor/ device malfunctions.

Typically, wherein the input cum LCD display device monitors the vital parameters such as body temperature of the baby, peripheral body temperature of the baby, air temperature, derived value of DeltaT, SpO2, heart rate, baby weight, and APGAR score.

Brief description of the drawings

Figure 1 shows a schematic drawing of the neonatal critical care system in accordance with the present invention; and
Figure 2 shows a block diagram of the system of figure 1;
Figure 3 shows a schematic drawing of a input cum LCD display device of figure 1; and
Figure 4 shows a load sensors mounted within the cradle, in accordance with the present invention.

Detailed description of the invention

The foregoing objects of the present invention are accomplished and the problems and shortcomings associated with the prior art, techniques and approaches are overcome by the present invention as described below in the preferred embodiment

The present invention provides a neonatal critical care system for use in hospital environment. The system of the present invention allows doctors to monitor the baby remotely. The system of the present invention is retrofit and can be used in existing set up of a hospital neonatal critical care units. Alternatively, the neonatal critical care system of the present invention can be used afresh in new hospitals which do not have existing set up for neonatal critical care. The integrated database of vital parameters with physiological markers and clinical records helps in early prognosis, prevention, and diagnosis of preterm babies.

Referring now to figure 1 and 2, there is a retrofit neonatal critical care system (100) which capable of connecting to existing baby warmer units having a heater (10), a cradle (20) and a pedestal (30). The neonatal critical care system (100) (hereinafter ‘the system (100)’) can either be used as retrofit or can be instilled afresh. The system (100) can be connected to existing baby warmer units easily without making any changes in the existing baby warmer unit. Specifically, the wires of the heater of the existing warmer units are required to be connected to the system (100) in order to make the existing baby warmer system as smart warmer system in accordance with the present invention.

The system (100) comprises a plurality of temperature sensors (40). The plurality of temperature sensors (40) includes at least one first sensor configured to measure foot temperature of the baby, at least one second sensor configured to measure a body temperature of the baby and at least one third air temperature sensor. Specifically, the plurality of temperature sensors helps to provide predictive analysis of the baby condition selected from any one of fever onset, heat stress onset, cold onset by calculation of DeltaT. For example, if the baby’s body temperature is higher as compared to his foot temperature due to fault in the heater, the difference in temperature is calculated and is provided for analysis for baby’s health condition which otherwise have been treated as fever in conventional baby warmer system.

The system (100) further comprises at least one thermoregulator (35) operably connected to the plurality of temperature sensors (40) for regulating load cycle of the heater of the baby warmer unit. The thermoregulator (35) regulates the load cycle of the heater as per the heater or temperature settings done by the user. The thermoregulator has built in safety features to control the heater (10) within safety zone and report if heater is malfunctioning.

The system (100) furthermore comprises a plurality of load cells (12) configured within a base of the cradle (20). Specifically, Figure 4 shows internals of the cradle (10) with load sensor (12) mounted on a bottom support plate (14). The cradle (20) of the existing baby warmer unit can be manipulated to keep these load sensors therein at four corners for continuously monitoring weight of the baby. In an embodiment, the load cells are configured within the base plate of the mattress of the cradle (10) while manufacturing. In conventional baby warmer units, the caretaker of the baby has to keep the baby in weighing machines every time to keep the record of the weight of the baby. The present invention overcomes this problem by providing load cells within the cradle (20) which continuously provides weight of the baby as one of the parameter. Specifically, neonates body undergoes rapid weight changes, which affects their nutrition demand and pharmacokinetic/ pharmacodynamics properties of drugs administered to the baby. Thus, continuous calculation is needed and is currently being performed manually by neonatologists to determine the appropriate nutrition and drug dosage. The real time weight recording using the load cells of the cradle (20) without lifting the baby and automating the drug and feed calculations helps to make the entire process safer, efficient and error free.

The system (100) further comprises at least one input cum LCD display device (50) operably connected to the cloud server to display, control and communicate data in real time. Specifically, the input cum LCD display device (50) is configured to monitor and display vital parameters of the baby and configured on the pedestal of existing baby warmer units. In an embodiment, the input cum display device (50) can be formed as integral part of the baby warmer units made in accordance with the present invention. The input cum LCD display device (50) monitors in real time the vital parameters of the baby such as body temperature of the baby, peripheral body temperature of the baby, air temperature, derived value of DeltaT, SpO2, heart rate, baby weight, APGAR score and shows this data continuously on the LCD screen. Furthermore, the input cum LCD display device (50) provides option to user to select the working modes i.e. manual or auto-mode and set the value of desired parameters to control the heater and connected devices functionality. The input cum LCD display provides an integrated dashboard view through a central monitoring station and also provides a collated view of neonatal critical care unit facility of the hospital along with the necessary personal and clinical details of the admitted newborns.

Once the personal data, maternal history, birth related child data and initial assessment of child’s health is updated in the digitized admission form through the input cum LCD display device, the baby is admitted to the neonatal critical care unit. Every admitted neonate is color-coded based on health condition i.e. critical, moderate and stable, so that attention could be prioritized from the first view itself. The input cum LCD display device also displays the neonatal critical care unit level of newborn along with the critical life supporting device parameters such as Temperature{ Abdomen-T1, Foot-T2, Air-T3 & Delta-T(T1-T2)}, Weight, peripheral oxygen saturation, Pulse rate and the like. The neonatal critical care unit dashboard gives a quick, consolidated and informative view of all neonates along with their necessary monitoring parameters and notifications/ alerts & printable reports. Specifically, the input cum LCD display (50) includes a lower box (52) having arrangement for sensor connections, an upper box (54) having touch screen with other essential components and brackets (56) for mooting the input cum LCD display (50) on the pedestal (30).

The system (100) furthermore comprises a cloud server (60) operably coupled to the plurality of temperature sensor (40), the plurality of load cells and the input cum LCD device (50). The cloud server (60) is configured to store the data and provides the data as and when demanded by the connected devices. Specifically, the doctors and nurses can connect to the cloud server (60) through an mobile application and check the data remotely on their mobile device screen which is available on the LCD display device.

The system (100) also comprises a central data processor (70) operably coupled to plurality of temperature sensors (40), and the load cells, the cloud server and the input and display device (50). Specifically, the central data processer (70) is configured to receive, communicate, and process the received data. The major role of the central data processor (70) is to calculate DeltaT from the data received from the plurality of temperature sensors (30) to predict the current baby condition and trigger alarms if any of the sensor/ device malfunctions. For example, if the baby’s body temperature is higher as compared to his foot temperature due to fault in the heater, the difference in temperature is calculated by the central data processor and is provided for analysis for baby’s health condition which otherwise have been treated as fever in conventional baby warmer system. This data is very useful for the doctor and nurses to determine the actual body parameter of the baby.

In a preferred embodiment, the central processor (70) is coupled to LED alarm (72) signal configured on the input cum LCD display device which glows continuously. In case of any alarm, the LED blinks with a buzzer sound which is indicative either in fault in the baby warmer system or sudden change in vital parameters of the baby. The central data processor (70) is also configured to manage the admission and discharge data of the baby, generating real time medical records of the baby, maintaining database of the past treatment past treatment in the cloud server which can be remotely accessed from any communication device such as desktop, tablet and mobile phone.

The central data processor (70) receive the detail of the admission of the baby through the input device, monitors and maintain the data throughout the admission of the baby in the neonatal critical care unit and prepares final discharge report based on the available data on real time basis. This saves the time of paramedical staff to create and submit the reports.

In a preferred embodiment, the central data processor (70) includes a data acquisition module for data acquisition related to baby’s body temperature and other vital parameters, a data analysis module to analyze the captured data, a memory unit to store the patient specific data for future reference and deciding mode of treatment, and a data transmission module for transmitting the data to the cloud server. Specifically, the data analysis module consists of associated clinical rules and notifications required in neonatal critical care unit.

The system (100) also includes IR sensor (not shown) which is configured on the pedestal of the baby warmer system. The IR sensor is operably coupled the alarm (72) and other indicators. The doctors or paramedical staff can waive their hand in front of the IR sensor which in turn stops all the alarms and indicators.

The system (100) of the present invention provides a complete digital transformation of neonatal critical care which allows concurrent real time access of multiple infants to clinical experts, provides analytics and an end-to-end care delivery and thus, improves the treatment outcome, quality and care time. Key long-term benefits of the present system are care, time improvement, filling skill gap, remote monitoring of rural regions by experts, early identification of disease, and reduction in neonatal mortality.

Advantages of the invention

1. The present invention provides is intelligent thermoregulation with interconnectivity and central as well as remote monitoring capability.

2. The system of the present invention provides an integrated temperature, oxygenation and baby weight monitoring with automatic alarming module.

3. The system of the present invention is good analytical tools for easier therapeutic decision making

4. The system of the present invention allows remote monitoring of the babies of the neonatal critical care units.

The foregoing object of the invention is accomplished and the problems and shortcomings associated with prior art techniques and approaches are overcome by the present invention described in the present embodiment. The detailed descriptions of the preferred embodiment are provided herein; however, it is to be understood that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching skilled workers in the art to employ the present invention in virtually any appropriately detailed Device, structure, or matter. The embodiments of the invention as described above and the methods disclosed herein will suggest further modification and alterations to those skilled workers in the art. Such further modifications and alterations may be made without departing from the spirit and scope of the invention.
,CLAIMS:We Claim:

1. A retrofit neonatal critical care system capable of connecting to existing baby warmer units having a heater, cradle and pedestal, the neonatal critical care system comprising:
a plurality of temperature sensors having ;
• at least one first sensor configured to measure foot temperature of a baby;
• at least one second sensor configured to measure a body temperature of the baby and;
• at least one third air temperature sensor, wherein the plurality of temperature sensors helps to provide predictive analysis of the baby condition selected from any one of fever onset, heat stress onset, cold onset by calculation of DeltaT;
at least one thermoregulator operably connected to the plurality of temperature sensors for regulating load cycle of the heater of the baby warmer unit;
a plurality of load cells configured within a base of the cradle for continuously monitoring weight of the baby;
at least one input cum LCD display device operably connected to the cloud server to display, control and communicate data in real time, the input cum LCD display device is configured to monitor and display vital parameters of the baby in real time;
a cloud server operably coupled to the plurality of temperature sensor, the plurality of load cells and the input cum LCD device; and
a central data processor operably coupled to plurality of temperature sensors, and the load cells, the cloud server and the input cum LCD display device, the central data processer configured to receive, communicate, and process received data, the central data processor is configured to calculate DeltaT from the data received from the plurality of temperature sensors to predict the current baby condition and trigger alarms if any of the sensor/ device malfunctions.

2. The system as claimed in claim 1, wherein the input cum display device monitors in real time the vital parameters such as body temperature of the baby, peripheral body temperature of the baby, air temperature, derived value of DeltaT, SpO2, heart rate, baby weight, and APGAR score.

3. The system as claimed in claim 1, wherein the input cum LCD display device provides option to user to select working modes i.e. manual or auto-mode and set value of desired parameters to control the heater and connected devices functionality.

4. The system as claimed in claim 1, wherein the central processor is coupled to LED alarm signal configured on the input cum LCD display device which glows continuously, in case of any alarm, blinks with a buzzer sound.

5. The system as claimed in claim 1, wherein the pedestal is configured with IR sensor for non-contact alarm silence.

6. The system as claimed in claim 1, wherein the central data processor is configured to manage the admission and discharge data of the baby, generating real time medical records of the baby, maintaining database of the past treatment in the cloud server which can be remotely accessed from any communication device such as desktop, tablet and mobile phone.

Dated this 23 June 2022