Intravascular Continuous Metabolic Monitoring and Multi-Sensor Intravascular Diagnostic System

Abstract

The invention relates to an intravenous micromodule with a multi-sensor architecture and an associated real-time decision support platform that enables continuous metabolic monitoring in the intravascular fluid phase. The system combines NIR spectroscopy, an electrochemical microprobe, a thermal flux sensor, and optical density analysis in a single compact IV module, providing real-time, uninterrupted, and highly accurate monitoring of the patient's metabolic status. The module measures critical parameters such as glucose, lactate, ketone bodies, electrolyte balance, and oxygenation in the intravascular fluid without requiring additional invasive procedures. Measurements are processed by the hybrid sensor fusion algorithm on the device, providing a low-latency data stream to the clinical decision support panel. The system detects metabolic disturbances with an early warning mechanism in scenarios such as emergency departments, intensive care units, operating rooms, and in-home chronic disease management.Unlike existing glucose monitors or single-parameter IV sensors, this invention presents the first hybrid architecture capable of monitoring multiple metabolic parameters simultaneously, continuously, and with high stability via the same vascular line. Furthermore, the dynamic liquid-phase referencing method developed for sensor calibration minimizes measurement drift during long-term use. This system offers significant advantages in areas such as early diagnosis of metabolic crises, treatment optimization, drug titration, and reduced clinical workload.

Description

Intravascular Continuous Metabolic Monitoring and Multi-Sensor Intravascular Diagnostic System Technical Area This invention has applications in medical devices, intravascular sensor technologies, metabolic monitoring systems, and emergency medicine. and relates to the fields of intensive care clinical decision support systems. In particular, intravenous continuous It relates to multi-sensor intravascular platforms that provide metabolic monitoring. State of the Art In current clinical practice, metabolic parameters (glucose, lactate, etc.) are measured through laboratory tests. It depends, and results are usually obtained with a delay of 20–60 minutes. This delay can lead to shock, sepsis. and makes early detection of conditions such as metabolic crisis more difficult. Non-invasive sensors have low It experiences a loss of reliability in patients undergoing perfusion. Current intravascular sensors, however, only... It is limited to pressure or single-parameter measurement. It can continuously measure multiple parameters. There is no intravascular system. Purpose of the Invention The invention aims to solve the aforementioned problems by being inspired by existing situations. It aims to... The primary objectives of the invention are: Simultaneous pressure and oxygenation control via intravascular means. To present a system capable of measuring perfusion, glucose, and lactate. Metabolic and hemodynamic. Detecting problems early. Seamless transition between ambulance, emergency room, and intensive care. To provide data flow. High performance in critically ill patients where non-invasive sensors are insufficient. To provide accuracy. To create an early warning system with clinical decision support algorithms. Description of the Invention The invention consists of the following parts: Sensor Layer - Consists of sensors placed sequentially on the catheter, and these Sensors; Pressure sensor (micro MEMS), NIR LED + photodiode pair, Glucose electrode, The lactate electrode is in the form of a micro-thermistor. The sensors are high-sample via the ADC. It is read at speed. 2 Firmware Structure; ADC management, Sensor drivers, Filtering (low-pass, moving average), Artifact detection, feature extraction (MAP, HR, SpO₂, PI, glucose / lactate trend), and BLE packaging. It consists of transmission, watchdog, and CRC security layers. Gateway Software; 1-hour data buffer, trend analysis, shock / sepsis / metabolic crisis It includes scoring, triage recommendations, and data sharing via the clinical interface. Clinical Interface; Trend graphs, Risk scores, Patient History and Triage color coding. It is in this form. The system that is the subject of the invention is a multi-sensor microcatheter that can be placed inside a blood vessel, and this It consists of a software architecture that processes data obtained from the catheter. Implementation of the invention. This is done through the following steps. Catheter placement into the vein: The catheter is inserted via a peripheral or central venous access. is administered to the patient. Pressure, optical and electrochemical sensors located at the tip of the catheter monitor the blood vessel. It comes into direct contact with the indoor environment. Continuous data collection by sensors: Pressure sensor → invasive blood pressure waveform, Optical Sensor (NIR / PPG) → oxygenation, perfusion, heart rhythm, Electrochemical sensors → Glucose and lactate levels, thermistor → monitors temperature data in real time. Sensors are high It continuously generates data at the sampling rate. Firmware-based data processing: The microcontroller on the catheter processes the sensor data. It receives data via ADC, filters it, removes artifacts, and extracts physiological characteristics (MAP, HR, SpO₂, PI, glucose / lactate trend). Wireless data transmission: The processed data is transmitted via a low-power wireless protocol (BLE, UWB). (or similar) the data is transferred to the gateway device. Trend analysis and decision support on Gateway: Gateway software analyzes at least one hour of data. By holding the buffer, it performs trend analysis. From this analysis, risk factors for shock, sepsis, and metabolic crisis are identified. Scores are generated. The system provides the clinician with color-coded triage outputs. Clinical interface visualization: Trend graphs, risk scores, parameter values, and alerts. It is displayed in a user-friendly interface. Thanks to this implementation method, the device that is the subject of the invention, Real-time monitoring of multiple physiological and metabolic parameters obtained from the intravascular environment. It becomes a platform that functions as such and can produce clinical decision support outputs. 3 Areas where the invention can be used: The invention can be used in all clinical settings where critically ill patients are managed. It is available for use. Its main areas of application are: Emergency Department; Hemodynamic and metabolic status of the patient from the moment of admission to the emergency department. It is monitored in real time. Shock and sepsis are detected early. Ambulance and Prehospital Care; Providing continuous data within the ambulance for prehospital care. It allows for early detection of critical situations during this period. Risks before arriving at the emergency room. Scores can be generated. Intensive Care Units; Inadequate use of non-invasive sensors in critically ill patients with low perfusion. It provides high accuracy in cases where it remains unchanged. Thanks to trend analysis, clinical deterioration can be detected early. It's noticeable. Trauma Management; Rapid detection of internal bleeding, loss of perfusion, and metabolic disturbance. It is done. Sepsis Diagnosis and Management; Lactate trends, temperature changes, and hemodynamic parameters. By evaluating them together, sepsis can be identified in the early stages. Metabolic Crises; Hypoglycemia, hyperglycemia, through continuous measurement of glucose and lactate, DKA onset and metabolic collapse are detected early. Utilizing the system described in this invention provides the following technical and clinical advantages: Technical Advantages; Integration of multiple sensors on a single intravascular platform. High Continuous data generation at sampling rate. Real-time data processing via firmware. Wireless and Low power consumption communication. Modular architecture allows for the integration of additional sensors. Clinical Advantages; Elimination of laboratory delays. Shock, sepsis, and metabolic disorders. Early detection of crises. Seamless data flow between ambulance, emergency room, and intensive care unit. Non- High accuracy in situations where invasive sensors are insufficient. Clinical decision support. Rapid triage using algorithms. Continuous monitoring of the patient's metabolic and hemodynamic status. monitoring. Operational Advantages; Accelerated critical decision-making in the pre-hospital phase. Intensive care. Reducing the workload. Data integrity among clinical teams. Remote monitoring and telemedicine. integration. 4 How the invention can be applied to industry. The invention is the world's first to continuously measure 5 parameters intravenously. It reduces laboratory delays. It eliminates the need for non-invasive sensors. It provides high accuracy in situations where non-invasive sensors are insufficient. It signals shock and sepsis in the early stages. Data loss between ambulance, emergency room, and intensive care unit. It eliminates the need for additional sensors. Thanks to its modular structure, it can be expanded with extra sensors in the future. Thanks to all the features mentioned above, the invention has industrial applicability. emergency medicine, intensive care, trauma management, sepsis diagnosis, metabolic crisis monitoring, and prehospital It can be used in care settings. The system is suitable for hospitals, ambulance services, and intensive care units. It is applicable by the units.

Claims

Claim 1. An intravascular monitoring system that can be implanted into a blood vessel and has at least one pressure sensor, at least one optical oxygenation and / or perfusion sensor, at least one electrochemical metabolic sensor (glucose, lactate or similar biochemical parameters) (for), a multi-sensor catheter containing at least one temperature sensor; the results obtained from these sensors an embedded system that samples, filters, processes, and extracts physiological characteristics from the collected data. firmware; a communication module that transmits processed data wirelessly to a receiving device; and the receiving device uses this data to perform trend analysis, risk scoring, and clinical decision-making. It is a system that includes software that produces support outputs. Claim 2. According to Claim 1, the multi-sensor catheter shall be placed sequentially along the same axis. It consists of installed pressure, optical and electrochemical sensors. Claim 3. In accordance with Claim 1, the optical sensor shall have at least one near-infrared (NIR) light source and at least It contains a photodiode and monitors oxygenation, perfusion and / or heart rhythm in the intravascular environment. taking the measurement. Claim 4. According to Claim 1, metabolic sensors detect glucose, lactate or similar biochemical substances. It has a microelectrode structure that measures parameters. Claim 5. In accordance with Claim 1, the pressure sensor's systolic, diastolic, and mean arterial pressure (MAP) and continuously measure hemodynamic parameters such as pulse pressure. Claim 6. In accordance with Claim 1, the system shall measure heart rhythm (HR) from an optical sensor or pressure waveform. Extracting it using the beat-to-beat method. Claim 7. According to Claim 1, the firmware's ADC management, multi-sensor sampling timing, Digital filtering, artifact detection, feature extraction (MAP, HR, SpO₂, PI, glucose / lactate trend), Data packaging, CRC-based integrity checking, and Watchdog security mechanism modules. includes Claim 8. In accordance with Claim 1, the software running on the receiving device must have at least one hour of sensor experience. buffering the data and performing trend analysis, and from this analysis, identifying shock, sepsis, or metabolic disorders. Generating a risk score for the crisis. Claim 9. According to Claim 1, the risk scores generated by the system should be color-coded into a clinical triage output. It includes a decision support module that transforms decisions. 6 Claim 10. In accordance with Claim 1, the wireless communication module of the device shall have a low power consumption. using a protocol (BLE, UWB, Zigbee or similar) to distribute data in periodic packets. transmitting. Request 11. According to Request 1, the system must provide uninterrupted communication between ambulance, emergency department and intensive care unit. It should be designed to facilitate data flow. Claim 12. According to Claim 1, the system requires additional sensor modules (urea, creatinine, electrolytes, a modular design that allows for the future integration of toxicological markers, etc. It has architecture. Claim 13. According to Claim 1, the system's data obtained from pressure, optical and metabolic sensors. a correlation analysis that identifies changes in physiological state by evaluating them together It should include the module. Claim 14. According to Claim 1, the system detects abrupt changes in sensor data and informs the clinician. early warning transmission. Claim 15. According to Claim 1, the system must process sensor data using CRC, encryption, or similar methods. transmitting it after passing it through an integrity check.