A non-invasive transcutaneous carbon monoxide detection-based neonatal jaundice risk assessment system and method

By using a non-invasive transcutaneous carbon monoxide detection system, the CO concentration in the newborn's skin can be monitored in real time, the bilirubin production rate can be calculated, and dynamic risk assessment can be performed by combining the TcB value. This solves the problem that changes in the bilirubin production rate cannot be tracked in existing technologies, and enables early and prospective warning of neonatal jaundice.

CN122376032APending Publication Date: 2026-07-14ANHUI PROVINCIAL HOSPITAL
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
ANHUI PROVINCIAL HOSPITAL
Filing Date
2026-04-28
Publication Date
2026-07-14

AI Technical Summary

Technical Problem

Existing technologies cannot track the dynamic changes in the rate of bilirubin production in newborns in real time and non-invasively, resulting in a lag in early warning of hyperbilirubinemia and an inability to achieve prospective and dynamic risk assessment.

Method used

By using non-invasive percutaneous carbon monoxide detection, the CO concentration in skin tissue is cyclically measured. The bilirubin production rate is calculated using the equimolar relationship between CO and bilirubin production, and dynamic risk assessment is performed in conjunction with TcB values. A system is constructed for automated bedside monitoring.

Benefits of technology

It enables early, prospective, and dynamic risk assessment of neonatal hyperbilirubinemia, accurately identifies hemolytic jaundice, supports the shift in clinical practice from passive response to proactive early warning, and achieves non-invasive, real-time monitoring at the bedside.

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Abstract

This invention discloses a neonatal jaundice risk assessment system and method based on non-invasive transcutaneous carbon monoxide (TcCO) detection, specifically relating to the field of medical device technology. The system includes: cyclically executing measurement steps to non-invasively measure the transcutaneous TcCO value in newborns; calculating the bilirubin production rate (BGR) based on the equimolar generation principle of carbon monoxide and bilirubin, according to each TcCO value; assessing the dynamic risk level based on the changing trend of BGR over time, and outputting auxiliary information. The system includes a transcutaneous carbon monoxide detection module, a data processing and control module, a risk assessment module, and an output module, with each module sequentially connected by signals. This invention achieves early, prospective warning of neonatal hyperbilirubinemia by cyclically monitoring the BGR trend, shifting clinical intervention from passive to proactive; combining the BGR threshold and transcutaneous bilirubin value, it can accurately identify hemolytic jaundice, achieving non-invasive, dynamic, and quantitative bedside risk assessment.
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Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a neonatal jaundice risk assessment system and method based on non-invasive transcutaneous carbon monoxide detection. Background Technology

[0002] Neonatal jaundice (neonatal hyperbilirubinemia) is the most common clinical problem in the neonatal period. Its root cause is elevated bilirubin levels in the blood, which can lead to irreversible neurological damage in severe cases. Bilirubin mainly originates from the degradation of hemoglobin in aging red blood cells. Under the catalysis of heme oxygenase, the heme ring structure is opened, releasing an equimolar amount of carbon monoxide (CO) and generating biliverdin, which is then rapidly converted back into bilirubin by biliverdin reductase. Therefore, there is a direct quantitative correlation between the rate of CO production and the rate of bilirubin production in the body. Currently, clinical techniques for assessing neonatal jaundice mainly include: transcutaneous bilirubin (TcB) measurement (such as the jaundice detection circuit and transcutaneous jaundice tester disclosed in CN112472025B, which estimates serum bilirubin concentration by measuring the difference in optical density of reflected light from the skin), serum total bilirubin (TSB) measurement (the invasive gold standard), and indirect assessment of bilirubin production by detecting end-tidal carbon monoxide (ETCO) (such as the infant exhaled gas collection device and detection method disclosed in CN112107333B, which collects infant exhaled gas in a semi-enclosed collection chamber to detect CO concentration). In addition, CN102379703A discloses a non-invasive neonatal jaundice monitoring system that uses an LED light source and a light-guiding fiber optic probe to monitor bilirubin levels in real time; CN109316169B discloses a health monitoring instrument based on a mobile smart terminal that uses a mobile phone flash and camera combined with grating spectrophotometry to detect multiple physiological indicators, including bilirubin.

[0003] However, the aforementioned existing technologies still have significant shortcomings: TcB and TSB reflect the results of bilirubin metabolism, i.e., the amount of bilirubin accumulated, rather than the rate of bilirubin production, leading to a lag in early warning of rapidly progressing pathological jaundice such as hemolysis; while CN112107333B can detect exhaled CO, it requires the infant to be placed in a closed collection room for 10-25 minutes, making the operation cumbersome and unable to achieve rapid, continuous dynamic monitoring at the bedside; CN102379703A and CN109316169B both measure bilirubin concentration based on optical principles, similarly only obtaining accumulation values ​​at single or discrete time points, unable to track the real-time dynamic changes in the rate of bilirubin production, and even less able to conduct prospective risk assessment based on these trends. Therefore, existing technologies cannot promptly identify high-risk newborns before bilirubin accumulates to dangerous levels, and clinical intervention remains in a reactive state.

[0004] Therefore, this invention provides a method and system for assessing the risk of neonatal jaundice based on non-invasive transcutaneous carbon monoxide detection. The aim is to achieve early, prospective, and dynamic risk assessment of neonatal hyperbilirubinemia by non-invasively and cyclically measuring transcutaneous carbon monoxide concentration and calculating the changing trend of bilirubin production rate. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a method and system for assessing the risk of neonatal jaundice that can non-invasively, in real time, and directly evaluate the bilirubin production rate and track its dynamic changes, so as to achieve early, prospective, and dynamic risk assessment of hyperbilirubinemia, especially hemolytic jaundice.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a method for assessing the risk of neonatal jaundice based on non-invasive percutaneous carbon monoxide detection, comprising the following steps: S1: Repeat the following measurement steps: Use the transcutaneous carbon monoxide detection module to non-invasively measure the carbon monoxide concentration under the skin tissue of the newborn and obtain the transcutaneous carbon monoxide (TcCO) measurement value; S2: Based on the physiological principle that the amount of carbon monoxide generated during heme degradation is equimolarly related to the amount of bilirubin generated, the bilirubin production rate (BGR) of the newborn in each cycle is calculated according to the transdermal carbon monoxide (TcCO) measurement value obtained in each cycle. S3: Based on the trend of the bilirubin production rate (BGR) calculated in each cycle, assess the dynamic risk level of the newborn developing hyperbilirubinemia and output the risk assessment results as auxiliary information.

[0007] Further, in S2, the bilirubin production rate BGR is calculated using the following formula: BGR = k × TcCO; Where k is the conversion factor.

[0008] Furthermore, in S3, the specific method for assessing the dynamic risk level based on the changing trend of BGR calculated in each cycle is as follows: Calculate the difference ΔBGR between two consecutive cycles of BGR = BGR i - BGR i-1 A positive number is preset as the fluctuation threshold; the difference ΔBGR is compared with the preset fluctuation threshold. If ΔBGR is greater than or equal to the critical value of the fluctuation twice in a row, it is judged to be a continuous upward trend; If ΔBGR is less than or equal to the negative of the fluctuation threshold twice in a row, it is judged to be a continuous downward trend; If the absolute value of ΔBGR is less than the critical value of the fluctuation in two consecutive instances, it is judged as a stable fluctuation. Specifically, a sustained upward trend is assessed as high risk, a sustained downward trend as low risk, and stable fluctuations as medium risk.

[0009] Furthermore, it also includes S0: measuring the transcutaneous bilirubin (TcB) value of the newborn; correspondingly, in S3, the risk assessment specifically involves: jointly assessing the dynamic risk level of the newborn developing hyperbilirubinemia based on the changing trend of the bilirubin production rate (BGR) calculated in each cycle and the transcutaneous bilirubin (TcB) value; wherein, when the BGR is in a stable fluctuation trend and the TcB value exceeds the 95th percentile corresponding to the newborn's age, the risk level is upgraded to high risk.

[0010] Further, S3 specifically includes: inputting the bilirubin production rate (BGR) trend and the transcutaneous bilirubin (TcB) value into a preset risk assessment matrix, wherein the risk assessment matrix outputs a high-risk, medium-risk, or low-risk level; wherein the risk assessment matrix uses a preset threshold range where the BGR trend and TcB value are located as two-dimensional coordinates, and the matrix cells are preset with high-risk, medium-risk, or low-risk levels.

[0011] Furthermore, in S1, the time interval between two adjacent measurements in a cycle is preset to be between 1 hour and 6 hours.

[0012] A neonatal jaundice risk assessment system based on non-invasive transcutaneous carbon monoxide detection for performing the method includes: a transcutaneous carbon monoxide detection module, a data processing and control module, a risk assessment module, and an output module; The output terminal of the transdermal carbon monoxide detection module is connected to the first input terminal of the data processing and control module, and is used to output the transdermal carbon monoxide (TcCO) measurement value to the data processing and control module. The first output terminal of the data processing and control module is connected to the first input terminal of the risk assessment module, and is used to output the trend data of bilirubin production rate (BGR) to the risk assessment module. The first output terminal of the risk assessment module is connected to the input terminal of the output module, and is used to output the dynamic risk level assessment result to the output module.

[0013] Furthermore, it also includes a transcutaneous bilirubin (TcB) detection module, the output of which is connected to the second input of the data processing and control module.

[0014] Furthermore, the output module is one or more combinations of a display screen, a sound alarm, and a data interface.

[0015] A computer-readable storage medium having a computer program stored thereon that, when executed by a processor, implements the steps of the method.

[0016] The technical effects and advantages of this invention are as follows: 1. Compared with the prior art, the method of the present invention achieves early and prospective warning of neonatal hyperbilirubinemia by cyclically performing transcutaneous carbon monoxide measurement and calculating the bilirubin production rate (BGR), and then assessing the dynamic risk level based on the changing trend of BGR. This solves the problem that traditional TcB and TSB only reflect the bilirubin accumulation result and cannot track the dynamic changes in the production rate, thus transforming clinical intervention from a passive response to an active warning.

[0017] 2. Compared with existing technologies, this method achieves accurate identification of hemolytic jaundice by setting a BGR threshold for risk stratification; it achieves comprehensive risk assessment by combining transcutaneous bilirubin TcB values ​​and the 95th percentile escalation rule; it achieves clinically adjustable dynamic monitoring by pre-setting cyclic measurement intervals of 1-6 hours; it achieves automated, non-invasive bedside risk assessment by constructing a system including a transcutaneous carbon monoxide detection module, a data processing and control module, a risk assessment module, and an output module, connected sequentially with signal input and output terminals; it achieves multi-parameter fusion and historical trend tracing by adding a transcutaneous bilirubin detection module and a storage unit; and it achieves standardized deployment of the method through computer-readable storage media. Attached Figure Description

[0018] Figure 1 This is a flowchart of the method of the present invention.

[0019] Figure 2 This is a system block diagram of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0021] Example 1: As attached Figure 1 The method for assessing the risk of neonatal jaundice based on non-invasive percutaneous carbon monoxide detection, as shown, includes the following steps: S1: The following measurement steps are performed cyclically: Using a percutaneous carbon monoxide (TcCO) detection module, the module is fixed to the skin at the manubrium of the newborn's sternum to non-invasively measure the carbon monoxide concentration in the subcutaneous tissue, obtaining the TcCO measurement value. For example, the unit of TcCO is ppm; if the measurement is performed every 2 hours, each measurement lasts for 30 seconds, and a stable TcCO value is recorded. In this embodiment, the process is repeated multiple times, and the interval between two adjacent measurements can be preset according to clinical needs.

[0022] This module employs a semiconductor-based MEMS gas sensor. The micro-hotplate structure within this sensor can be referenced in patent CN111693577B, which discloses a MEMS micro-hotplate based on an air insulation layer to provide a stable operating temperature for the gas-sensitive material. Specifically, the micro-hotplate comprises, from bottom to top, a silicon substrate, a lower insulating layer, an upper insulating layer, and a cover layer. The upper insulating layer contains an array of through-holes and an air insulation layer, which is a cuboid cavity used to suppress heat loss to the outside of the heating platform. The silicon substrate thickness is 200–500 μm, and the air insulation layer thickness is 0.5–2.0 μm. The heating electrode and the test electrode are located on the same layer above the cover layer, with the test electrode surrounded by the heating electrode. Based on this, a gas-sensitive material sensitive to carbon monoxide, such as a metal oxide semiconductor or mesoporous semiconductor material, is used to construct a complete MEMS gas sensor. In other words, the MEMS micro-hotplate coupled with the gas-sensitive material forms a transdermal carbon monoxide detection module to collect CO gas.

[0023] The feasibility of the transdermal carbon monoxide detection module is supported by the following publicly available technologies: (1) The MEMS micro-hot plate provides a stable operating temperature for the gas-sensitive material. The micro-hot plate is the core component of the MEMS gas sensor. (2) CO gas sensors based on MEMS micro-hot plates, such as CO gas sensors using pulse heating methods, have an electrical response of 34.3 to 200 ppm CO (Reference: Li et al., IEEE Electron Device Letters, 2024), and MEMS gas sensors using TiO2 thin films have a response of 96.14% to 5 ppm CO (Reference: Rao LR, 2021 paper); where 1 ppm = 1000 ppb; (3) Sensitive materials such as palladium oxide nanoparticles have been used for CO detection on MEMS micro hot plates.

[0024] S2: Based on the physiological principle that the amount of carbon monoxide produced during heme degradation is equimolarly to the amount of bilirubin produced, the main source of bilirubin in the human body is the degradation of hemoglobin in aging red blood cells. Specifically, the porphyrin ring structure of heme in hemoglobin is opened under the catalysis of heme oxygenase. This ring-opening reaction produces three products: carbon monoxide, biliverdin, and free iron. Biliverdin is then rapidly converted into bilirubin under the action of biliverdin reductase. For example, 1 mol of heme degradation → 1 mol of carbon monoxide + 1 mol of bilirubin; that is, the amount of carbon monoxide produced is in a 1:1 molar ratio to the amount of bilirubin produced. Therefore, by measuring the rate of carbon monoxide production in newborns, the transdermal CO concentration can be obtained, and the bilirubin production rate (BGR) can be directly and quantitatively calculated.

[0025] Based on the transcutaneous carbon monoxide (TcCO) measurement values ​​obtained in each cycle, the bilirubin production rate (BGR) of the newborn in that cycle is calculated. The BGR for each cycle is calculated using the formula BGR = k × TcCO, where k is a conversion factor, and in this example, k = 0.5 (μmol / (kg·h·ppm)). This value is an example; in practical applications, it can be determined through clinical studies. The BGR value for each cycle is thus obtained.

[0026] S3: Based on the trend of bilirubin production rate (BGR) calculated in each cycle, assess the dynamic risk level of the newborn developing hyperbilirubinemia and output the risk assessment results as auxiliary information.

[0027] For example, if BGR < 0.8 μmol / (kg·h), the risk is assessed as low; if 0.8 ≤ BGR < 1.2 μmol / (kg·h), the risk is assessed as medium, and enhanced monitoring is recommended; if BGR ≥ 1.2 μmol / (kg·h), regardless of the TcB value, the risk is assessed as high, indicating possible acute hemolysis, requiring immediate serological confirmation and intervention. Ultimately, this risk assessment result serves as supplementary information for physicians' clinical decision-making.

[0028] Example 2: This embodiment further illustrates the calculation formula for BGR based on Example 1. The defined formula BGR = k × TcCO has been specifically implemented in S2 of Example 1, where k is a conversion factor, and in this embodiment, k is taken as 0.5 μmol / (kg·h·ppm). This formula is based on the physiological principle of equimolar generation of carbon monoxide and bilirubin, and is the core quantitative relationship for calculating the bilirubin generation rate.

[0029] (Note: Since this formula has been fully disclosed in Example 1, this example is only a formal correspondence and does not repeat the substantive content.) Example 3: This embodiment is based on embodiment 1, as shown in the appendix. Figure 1 As shown in Figure S3, the specific method for assessing the dynamic risk level based on the changing trend of BGR calculated in each cycle is as follows: Calculate the difference between BGR in two adjacent cycles, ΔBGR = BGR i -BGR i-1 A positive number is preset as the fluctuation threshold; the difference ΔBGR is compared with the preset fluctuation threshold. According to clinical literature, the rate of increase in serum total bilirubin (TSB) in healthy full-term infants is less than 3.4 μmol / (L·h), while the rate of increase in TSB in infants with Rh hemolytic disease can be greater than 8.5 μmol / (L·h). Converting this to a neonatal blood volume of 0.085 L / kg, the critical value for the rate of change in BGR in normal newborns is: TSB increase rate × blood volume = 3.4 μmol / (L·h) × 0.085 L / kg = 0.289 μmol / (kg·h). In this embodiment, a preset fluctuation threshold of 0.3 μmol / (kg·h) is used as the threshold to distinguish between stable fluctuations and continuous increases / decreases. In practical applications, this threshold can be adjusted based on clinical research.

[0030] If ΔBGR ≥ 0.3 μmol / (kg·h) twice consecutively, it is judged to be a continuous upward trend; If ΔBGR ≤ -0.3 μmol / (kg·h) twice consecutively, it is judged as a continuous downward trend; If the absolute value of ΔBGR is <0.3 μmol / (kg·h) for two consecutive times, it is judged as a stationary fluctuation; Specifically, a sustained upward trend is assessed as high risk, a sustained downward trend as low risk, and stable fluctuations as medium risk. See the table below:

[0031] Example 4: This embodiment is based on embodiment 3, as shown in the appendix. Figure 1 As shown, it also includes S0: measuring the transcutaneous bilirubin (TcB) value of the newborn; specifically: using a transcutaneous bilirubin analyzer, simultaneously measuring the TcB value at the same site as the TcCO measurement, such as the manubrium of the sternum.

[0032] Correspondingly, in S3, the risk assessment is specifically as follows: based on the trend of bilirubin production rate (BGR) and transcutaneous bilirubin (TcB) values ​​calculated in each cycle, the dynamic risk level of the newborn developing hyperbilirubinemia is jointly assessed; among them, when the BGR is in a stable fluctuation trend and the TcB value exceeds the 95th percentile corresponding to the newborn's age, the risk level is upgraded to high risk.

[0033] For example, when BGR is in the medium-risk range (0.8 ≤ BGR < 1.2 μmol / (kg·h)), but the TcB value has exceeded the 95th percentile corresponding to the newborn's age, the risk level is upgraded from medium-risk to high-risk.

[0034] The 95th percentile refers to the 95th percentile value of the corresponding age as specified in the neonatal hourly bilirubin percentile curve (such as the 95th percentile value of the corresponding age as specified in the American Academy of Pediatrics' Guidelines for the Management of Neonatal Hyperbilirubinemia or the Chinese Expert Consensus on the Diagnosis and Treatment of Neonatal Hyperbilirubinemia). This percentile curve is a well-known clinical assessment tool in the field.

[0035] Example 5: This embodiment further defines S3 based on embodiment 4, as shown in the appendix. Figure 1 As shown, S3 specifically includes: inputting the bilirubin production rate (BGR) trend and the transcutaneous bilirubin (TcB) value into a preset risk assessment matrix, and the risk assessment matrix outputs a high-risk, medium-risk, or low-risk level; wherein, the risk assessment matrix uses the preset threshold range of the BGR trend and the TcB value as a two-dimensional coordinate, and the matrix cells are preset with high-risk, medium-risk, or low-risk levels.

[0036] The preset threshold range for TCB values ​​can be divided according to the bilirubin percentile curve corresponding to the newborn's age. For example, below the 40th percentile is the first range (low level), from the 40th to the 95th percentile is the second range (moderate level), and above the 95th percentile is the third range (high level). The above range division is only an example and can be adjusted according to clinical needs in actual application.

[0037] For example, as shown in the table below: The risk assessment matrix uses BGR and TcB as two dimensions. The horizontal axis represents TcB values, categorized into low, medium, and high levels. The vertical axis represents the BGR trend, categorized into downward, stable, and upward trends. Each cell in the matrix has a pre-defined risk level. For instance, an upward BGR trend with a high TcB level corresponds to high risk; a downward BGR trend with a low TcB level corresponds to low risk.

[0038]

[0039] Example 6: This embodiment, based on Embodiment 1, further defines the time interval between cyclic measurements. Specifically, as shown in the attached... Figure 1 As shown in S1, the time interval between two consecutive measurements in a cycle is preset to 1 to 6 hours. This interval can be manually adjusted by the clinician according to the child's condition.

[0040] Example 7: As attached Figure 2 As shown, this embodiment provides a neonatal jaundice risk assessment system based on non-invasive transcutaneous carbon monoxide detection for performing the method. The system includes: a transcutaneous carbon monoxide detection module, a data processing and control module, a risk assessment module, and an output module. A transcutaneous carbon monoxide (TcCO) detection module is used to non-invasively measure the carbon monoxide concentration under the skin tissue of a newborn and obtain the TcCO measurement value. The output of the transcutaneous TcCO detection module is connected to the first input of a data processing and control module to output the TcCO measurement value to the data processing and control module. The data processing and control module receives the TcCO measurement value and, based on the physiological principle that carbon monoxide and bilirubin coexist in a 1:1 molar ratio, calculates the bilirubin production rate (BGR) of the newborn and further tracks the trend of changes in the calculated bilirubin production rate. The first output of the data processing and control module is connected to the first input of a risk assessment module to output the trend data of the BGR. The risk assessment module is used to assess the dynamic risk level of hyperbilirubinemia in the newborn based on the trend of the bilirubin production rate and generate a risk assessment result. The first output of the risk assessment module is connected to the input of an output module to output the dynamic risk level assessment result to the output module. The output module is used to display or output the risk assessment result.

[0041] Specifically, the transdermal carbon monoxide detection module employs a miniature electrochemical CO sensor, the data processing and control module uses a microcontroller (MCU), the risk assessment module is implemented using software algorithms (existing software algorithms can be used), and the output module is an LCD display. The system can automatically execute measurement cycles at preset time intervals, continuously recording and storing the results.

[0042] like Figure 2 As shown, the system also includes a storage unit. The second output of the data processing and control module is connected to the first input of the storage unit. The second input and first output of the storage unit are respectively connected to the second output and second input of the risk assessment module. This storage unit stores the TcCO measurement values, bilirubin production rate (BGR), and dynamic risk level assessment results obtained from each cycle. The storage unit can use an EEPROM, Flash chip, or SD card to save historical data for doctors to review trend charts.

[0043] Example 8: This embodiment is based on embodiment 7, as shown in the appendix. Figure 2 As shown, the system also includes a transcutaneous bilirubin (TcB) detection module. The output of this module is connected to the second input of the data processing and control module. The TcB detection module, based on the principle of dual-wavelength reflectance spectroscopy, simultaneously measures the concentration of bilirubin in the skin. The data processing and control module simultaneously receives TcCO and TcB signals, calculates the BGR and records the TcB value respectively, and sends both to the risk assessment module for comprehensive risk assessment.

[0044] Example 9: This embodiment, based on Embodiment 7, further defines the specific form of the output module. The output module is one or more combinations of a display screen, an audible alarm, and a data interface. For example, a color LCD display screen is used to display the current TcCO, BGR, TcB, and risk level in real time; when the risk assessment result is high risk, the audible alarm emits intermittent beeps; and at the same time, the data is transmitted to the central monitoring system at the nurse station in real time via a Bluetooth data interface.

[0045] Example 10: This embodiment provides a computer-readable storage medium. The storage medium stores a computer program that, when executed by a processor, implements the steps of a method for assessing neonatal jaundice risk based on non-invasive percutaneous carbon monoxide detection. For example, the storage medium is an SD card or an eMMC chip, and the program includes instruction code for a measurement control module, a BGR calculation module, a trend analysis module, and a risk assessment module.

[0046] The risk assessment results of this invention are only intended to provide doctors with supplementary reference information to indicate the possibility of neonatal hyperbilirubinemia. The final conclusion should be made by a doctor in conjunction with gold standards such as serum total bilirubin testing. This invention does not replace the professional judgment of a doctor and does not directly provide a result for the disease.

[0047] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0048] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for assessing the risk of neonatal jaundice based on non-invasive transcutaneous carbon monoxide detection, characterized in that, Includes the following steps: S1: Repeat the following measurement steps: Use the transcutaneous carbon monoxide detection module to non-invasively measure the carbon monoxide concentration under the skin tissue of the newborn and obtain the transcutaneous carbon monoxide (TcCO) measurement value; S2: Based on the physiological principle that the amount of carbon monoxide generated during heme degradation is equimolarly related to the amount of bilirubin generated, the bilirubin production rate (BGR) of the newborn in each cycle is calculated according to the transdermal carbon monoxide (TcCO) measurement value obtained in each cycle. S3: Based on the trend of the bilirubin production rate (BGR) calculated in each cycle, assess the dynamic risk level of the newborn developing hyperbilirubinemia and output the risk assessment results as auxiliary information.

2. The method for assessing neonatal jaundice risk based on non-invasive percutaneous carbon monoxide detection according to claim 1, characterized in that: In S2, the bilirubin production rate BGR is calculated using the following formula: BGR = k × TcCO; Where k is the conversion factor.

3. The method for assessing neonatal jaundice risk based on non-invasive transcutaneous carbon monoxide detection according to claim 1, characterized in that: In S3, the specific method for assessing the dynamic risk level based on the changing trend of BGR calculated in each cycle is as follows: Calculate the difference ΔBGR between two consecutive cycles of BGR = BGR i - BGR i-1 A positive number is preset as the fluctuation threshold. The difference ΔBGR is compared with a preset fluctuation threshold. If ΔBGR is greater than or equal to the critical value of the fluctuation twice in a row, it is judged to be a continuous upward trend; If ΔBGR is less than or equal to the negative of the fluctuation threshold twice in a row, it is judged to be a continuous downward trend; If the absolute value of ΔBGR is less than the critical value of the fluctuation in two consecutive instances, it is judged as a stable fluctuation. Specifically, a sustained upward trend is assessed as high risk, a sustained downward trend as low risk, and stable fluctuations as medium risk.

4. The method for assessing neonatal jaundice risk based on non-invasive percutaneous carbon monoxide detection according to claim 3, characterized in that: It also includes S0: measuring the transcutaneous bilirubin (TcB) value of the newborn; correspondingly, in S3, the risk assessment specifically involves: jointly assessing the dynamic risk level of the newborn's hyperbilirubinemia based on the changing trend of the bilirubin production rate (BGR) calculated in each cycle and the transcutaneous bilirubin (TcB) value; wherein, when the BGR is in a stable fluctuation trend and the TcB value exceeds the 95th percentile corresponding to the newborn's age, the risk level is upgraded to high risk.

5. The method for assessing neonatal jaundice risk based on non-invasive transcutaneous carbon monoxide detection according to claim 4, characterized in that: S3 specifically includes: inputting the bilirubin production rate (BGR) trend and the transcutaneous bilirubin (TcB) value into a preset risk assessment matrix, wherein the risk assessment matrix outputs a high-risk, medium-risk, or low-risk level; wherein the risk assessment matrix uses a preset threshold range of BGR trend and TcB value as a two-dimensional coordinate, and the matrix cells are preset with high-risk, medium-risk, or low-risk levels.

6. The method for assessing neonatal jaundice risk based on non-invasive transcutaneous carbon monoxide detection according to claim 1, characterized in that: In S1, the time interval between two adjacent measurements in a cycle is preset to be between 1 hour and 6 hours.

7. A neonatal jaundice risk assessment system based on non-invasive transcutaneous carbon monoxide detection for performing the method according to any one of claims 1-6, characterized in that: include: Transdermal carbon monoxide detection module, data processing and control module, risk assessment module, and output module; The output terminal of the transdermal carbon monoxide detection module is connected to the first input terminal of the data processing and control module, and is used to output the transdermal carbon monoxide (TcCO) measurement value to the data processing and control module. The first output terminal of the data processing and control module is connected to the first input terminal of the risk assessment module, and is used to output the trend data of bilirubin production rate (BGR) to the risk assessment module. The first output terminal of the risk assessment module is connected to the input terminal of the output module, and is used to output the dynamic risk level assessment result to the output module.

8. A neonatal jaundice risk assessment system based on non-invasive transcutaneous carbon monoxide detection according to claim 7, characterized in that: Also includes: The output of the transcutaneous bilirubin (TcB) detection module is connected to the second input of the data processing and control module.

9. A neonatal jaundice risk assessment system based on non-invasive transcutaneous carbon monoxide detection according to claim 7, characterized in that: The output module is one or more of the following: a display screen, a sound alarm, and a data interface.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the program is executed by the processor, it implements the steps of the method as described in any one of claims 1-6.