Interventional operation safety management system

Abstract

The invention provides an interventional operation safety management system which comprises a cloud server, a double-end-side mobile APP and a robot which are connected pairwise, the cloud server comprises an external system integration module, a business logic and service module and a data storage and analysis module, and the double-end-side mobile APP comprises a medical staff end APP and a patient end APP. The robot is specially deployed in an interventional operation catheter room to achieve remote control and parameter configuration, automatic operation process processing and intelligent information collection and uploading in an operation. According to the system, through the cooperation of the data processing capability of the cloud server, the convenient interaction function of the double-end side mobile APP and the field execution capability of the robot, automatic process reminding and execution supervision of the whole interventional operation process, automatic collection and recording of key diagnosis and treatment data in the operation, closed-loop management of medicine and consumable use in the operation, and automatic management of the whole interventional operation process are achieved. Personalized rehabilitation guidance is provided for a patient after an operation, so that the safety, the compliance and the traceability of the interventional operation are guaranteed.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical informatization and intelligent diagnosis and treatment management, in particular to an interventional surgery safety management system based on cloud server, mobile application (APP) and robot collaboration. BACKGROUND

[0002] With the continuous progress of medical technology, interventional surgery as a minimally invasive treatment method has been widely used in the fields of cardiovascular medicine, neurology, respiratory medicine, and vascular surgery. Interventional surgery is a high-precision and high-risk diagnosis and treatment operation. Its success and safety highly depend on the strict execution of complex procedures by the surgical team and the accurate management of key information such as patient identity, surgical site, medication and consumables. However, the safety check, consumable registration, drug management and various records in current interventional surgery still mainly rely on traditional manual methods, which have the following outstanding problems:

[0003] 1) The verification process relies on human execution and lacks reliability: especially in situations of surgical tension and personnel fatigue, it is easy to simplify, omit or formalize the process, which brings safety hazards.

[0004] 2) Intraoperative record efficiency is low and error risk is high: interventional surgery usually only has one nurse, with multiple work contents and more expensive consumables during the operation. Currently, it mainly relies on handwritten or computer input methods, which not only have low efficiency, but also are more likely to have record errors, omissions or delays in emergency situations, affecting medical quality traceability and cost control.

[0005] 3) Serious information silos: patient information, surgical plans, drug and consumable inventories, and other data are scattered in various systems and cannot be linked in real time with the surgical process, making it difficult to achieve automatic data collection and closed-loop management.

[0006] 4) Lack of objective process tracking means: in the event of medical disputes or adverse events, there is a lack of visual and objective process records to restore key operation nodes, which is not conducive to post-analysis and responsibility identification.

[0007] Although some existing operating room information management systems have certain informatization functions, they are mostly limited to fixed terminal operations and require manual intervention, and cannot achieve active interaction and automatic data collection in physical space. Therefore, there is an urgent need for a solution that can intelligently integrate into the surgical process, achieve non-invasive real-time monitoring and automatic verification, recording, intraoperative medication and consumable statistical management. SUMMARY

[0008] In view of the technical problems of high dependence on manual operation, insufficient process reliability and difficulty in information tracing in the existing interventional operation management, the present application provides an interventional operation safety management system based on cloud server, mobile application (APP) and robot cooperation, which realizes full-process automatic management driven by operation doctor's order through the technical cooperation of the three, and further guarantees the safety, compliance and traceability of interventional operation.

[0009] In order to solve the above technical problems, the present application adopts the following technical scheme:

[0010] An interventional operation safety management system, comprising a cloud server, a double-end mobile APP and a robot, the cloud server, the double-end mobile APP and the robot are connected with each other in pairs; wherein,

[0011] The cloud server comprises an external system integration module, a business logic and service module, and a data storage and analysis module, the external system integration module realizes seamless association and docking with the existing information system of the hospital based on a standardized interface protocol, automatically extracts operation doctor's order data, patient basic information and diagnosis and treatment information data, and preliminarily screens and formats the extracted unstructured data, providing standardized data input support for subsequent instruction generation and data analysis of the business module; the business logic and service module is used for receiving and processing the standardized operation information and patient information data transmitted by the external system integration module, and receiving in real time the operation progress data uploaded by medical staff in the operation execution process through AI voice recognition technology and AI image recognition technology, and generating checking instructions in accordance with the clinical specifications of interventional operation for the above two types of data; the data storage and analysis module is used for storing the interventional operation standardized process knowledge base and the full-amount structured data generated in the operation execution process, and performing structured analysis and classification archiving on the stored data, and constructing an operation experience knowledge base based on the analysis results;

[0012] The double-end mobile APP comprises a medical staff end APP and a patient end APP, the medical staff end APP is based on the data issued by the cloud server and the real-time monitoring of the robot, and is used for providing services such as operation whole cycle management, task execution guidance, information real-time recording and data encryption synchronization to medical staff; the patient end APP is used for providing preoperative preparation guidance to patients based on the preoperative preparation list specially issued for patients by the cloud server, and pushing personalized postoperative rehabilitation guidance to patients through the cloud server based on the patient's operation recovery stage and operation type, to assist patients to complete the whole cycle nursing;

[0013] The robot is specially deployed in the interventional operation catheter room, and is used for realizing remote control and parameter configuration, operation process automatic processing, and in-operation information intelligent collection and uploading to the cloud server and the medical staff end APP.

[0014] Further, the business logic and service module generates the check instructions conforming to the clinical specifications of the intervention surgery for the two types of data, including: first, completing data feature extraction and weight calculation through a preset dynamic feature extraction algorithm, then performing multi-dimensional data comparison with the built-in surgery specification knowledge base, and finally generating the check instructions conforming to the clinical specifications of the intervention surgery by using a multi-objective optimization algorithm.

[0015] Further, the intervention surgery standardized procedure knowledge base stored in the data storage and analysis module covers the whole procedure links including preoperative preparation, catheter room preparation, pre-puncture / general anesthesia check, intraoperative key operation node, and postoperative check, and each link contains corresponding standardized task list and operation risk prompt; the full amount of structured data generated during the surgery execution stored in the data storage and analysis module includes patient surgery whole procedure execution log, intraoperative consumable use details, and intraoperative drug use record.

[0016] Further, the medical staff terminal APP includes a remote management and monitoring module, a surgery task execution module, an intraoperative recording module, and a data synchronization module, the remote management and monitoring module synchronizes data based on the cloud server, supports medical staff to remotely complete surgery scheme parameter configuration, robot running state monitoring, surgery whole procedure progress viewing operation, receives abnormal alarm information pushed by the system at the same time, and supports historical surgery record browsing; the surgery task execution module receives surgery arrangement information issued by the cloud server in real time, and accurately pushes it to the corresponding medical staff based on role permission, and on the other hand, in the surgery execution process, it guides medical staff to complete the operation step by step through interaction according to the preset standardized procedure; the intraoperative recording module supports medical staff to collect and record surgery key information, surgery consumable UDI code identification association and input, surgery key step photographing and archiving, and surgery key node electronic signature confirmation in real time; the data synchronization module is used to encrypt and synchronize the execution data generated during the whole surgery procedure to the cloud server in real time, and supports offline buffering function at the same time.

[0017] Further, the robot is used to realize the remote control and parameter configuration function, including: supporting medical staff to remotely complete the movement path planning of the robot, task start / pause control and system parameter configuration through the medical staff terminal APP.

[0018] Further, the robot is used to realize the surgery procedure automation processing function, including: after the robot loads the intervention surgery standardized procedure issued by the cloud server, it automatically executes the surgery key node check, surgery whole procedure supervision, and surgery link information recording.

[0019] Further, the robot is used to realize intelligent collection and uploading of intraoperative information, comprising: the robot identifies intraoperative instructions and operation descriptions of medical staff through an AI voice recognition module carried by the robot, automatically extracts drug names, dosages and consumable type information; and identifies intraoperative drug packaging, consumable UDI codes and patient vital sign monitor screen data through an AI image recognition module carried by the robot, accurately extracts structured information; and then the collected information is encrypted and uploaded to a cloud server in real time, and is simultaneously synchronized to a medical staff terminal APP.

[0020] Compared with the prior art, the interventional operation safety management system provided by the application realizes automatic process reminding and execution supervision of the whole interventional operation process, automatic collection and recording of key diagnosis and treatment data during operation, closed-loop management of intraoperative drugs and consumables, and personalized rehabilitation guidance for patients after operation, finally builds a complete safety management closed loop covering "pre-operation-intraoperative-postoperative" between medical staff and patients, and further guarantees the safety, compliance and traceability of interventional operation. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 is the overall architecture diagram of the interventional operation safety management system provided by the application.

[0022] Figure 2 is a schematic diagram of the cloud server provided by the application.

[0023] Figure 3 is a function distribution diagram of the double-end mobile APP provided by the application.

[0024] Figure 4 is a function distribution diagram of the robot provided by the application.

[0025] Figure 5 is a core data flow and interaction schematic diagram in the interventional operation safety management system provided by the application. DETAILED DESCRIPTION

[0026] In order to make the technical means, creative features, purposes and effects realized by the application easy to understand, the application is further described below in combination with specific diagrams.

[0027] Please refer to Figures 1 to 5 The application provides an interventional operation safety management system, comprising a cloud server, a double-end mobile APP and a robot, the cloud server, the double-end mobile APP and the robot are connected with each other in pairs; wherein,

[0028] The cloud server as the core data processing and instruction center of the system adopts modular design, specifically including external system integration module, business logic and service module, data storage and analysis module, the function positioning of each module is as follows:

[0029] The external system integration module realizes seamless connection with the existing hospital information system (HIS system) based on standardized interface protocol (such as API interface), can automatically extract surgical order data (including operation type, operation time, intraoperative drug / commodity list), patient basic information (including identity information, medical history data) and diagnosis and treatment information (including preoperative examination results, allergy history, etc.) data, and preliminarily screen and format convert the extracted unstructured data, providing standardized data input support for subsequent business module (business logic and service module, data storage and analysis module) instruction generation and data analysis.

[0030] The business logic and service module is the core operation unit of the cloud server, with dual technical capabilities of data fusion processing and compliance verification instruction generation, on the one hand for receiving and processing standardized surgical information and patient information data transmitted by the external system integration module, on the other hand can receive real-time surgical progress data (including completed nodes, to be executed nodes) and associated information (including intraoperative abnormal situation description) uploaded by medical personnel in the operation execution process through AI voice recognition technology (supporting medical professional term recognition, recognition accuracy ≥95%) and AI image recognition technology (supporting commodity UDI code recognition, operation scene recognition), for the above two types of data, the module first completes data feature extraction and weight calculation through the preset dynamic feature extraction algorithm (such as feature weight distribution model based on deep learning), then carries out multi-dimensional data comparison with the built-in operation specification knowledge base, finally generates verification instructions (including operation guide, risk warning prompt) conforming to the clinical specification of interventional operation by using multi-objective optimization algorithm.

[0031] The data storage and analysis module adopts a distributed storage architecture and possesses three technical functions: data storage, structured analysis, and iterative knowledge base construction. Specific functions include: ① storing a standardized interventional surgery procedure knowledge base, which covers the entire process, including preoperative preparation (patient identification, surgery type, puncture site marking), catheterization lab preparation (equipment disinfection status verification, consumable preparation list), pre-puncture / general anesthesia verification (allergy history confirmation, anesthesia protocol verification), key intraoperative operation nodes (secondary surgery communication records, real-time records of emergency medications, consumable usage traceability), and post-operative verification (instrument count, patient vital sign confirmation). Each step includes a corresponding standardized task list and operational risk warnings; ② storing surgical execution. The full amount of structured data generated during the process includes, but is not limited to, the patient's surgical procedure log (including operation time and personnel), intraoperative consumable usage details (including unique code, specifications, manufacturer, and quantity used), and intraoperative drug usage records (including drug name, dosage, route of administration, and usage time); ③ The stored data is subjected to structured analysis (such as surgical duration statistics, consumable usage rate analysis, and adverse event correlation factor mining) and classified archiving, and a surgical experience knowledge base is built based on the analysis results. By accumulating successful surgical cases (including operation procedures and key parameters) and abnormal situation handling templates (including troubleshooting steps and emergency plans), data support is provided for the system's self-learning optimization (such as improving the accuracy of verification instructions and optimizing the timeliness of risk warnings).

[0032] The dual-end mobile app is designed based on user role differentiation, including a medical staff app and a patient app. The functional modules of each app are developed around the needs of the entire process of interventional surgery from pre-operative to intra-operative to post-operative. The specific technical implementation and functions are as follows:

[0033] The medical staff-facing app is designed for surgeons, nurses, anesthesiologists, and other medical personnel. Based on data distributed from a cloud server and real-time robot monitoring, it provides core services including full-cycle surgical management, task execution guidance, real-time information recording, and encrypted data synchronization. Specifically, the medical staff-facing app includes the following functional modules:

[0034] Remote Management and Monitoring Module: This module synchronizes data based on a cloud server and supports medical staff in remotely completing three core operations: ① Surgical plan parameter configuration, including surgical type matching (such as cardiovascular intervention, neurointervention), setting key node times and precautions (such as pre-puncture verification time window, intraoperative consumable replacement nodes, preparation before balloon dilation, etc.); ② Robot operation status monitoring, including real-time acquisition of the robot's physical position (accuracy ≤ 0.5m), remaining battery power (display accuracy ≤ 1%), current task execution progress (including the percentage of completed / pending tasks), and real-time marking of abnormal states (such as battery power below 20%, position deviation exceeding the threshold); ③ Viewing the entire surgical process progress, displaying completed nodes (green markers), pending nodes (blue markers), and abnormal nodes (red markers) through a visual timeline, while receiving abnormal alarm information pushed by the system (such as robot failure, data synchronization interruption), and supporting access to historical surgical records (including operation logs, verification results, and intraoperative key data reports), realizing remote control and traceability of the entire surgical cycle.

[0035] Surgical Task Execution Module: This module has dual functions of automatic task reception and standardized guidance. On the one hand, it receives surgical arrangement information (including surgical time, patient name, hospital number, surgical type, and list of participating medical staff) from the cloud server in real time and pushes it accurately to the corresponding medical staff based on role permissions. On the other hand, during the surgical execution, it guides medical staff to complete the operation step by step according to the preset standardized process through interactive methods such as voice prompts (supporting multilingual switching) and graphic guidance (including operation step diagrams and risk warning pop-ups). This includes confirming the completion of preoperative ward preparation, checking and verifying preoperative instruments, and confirming key steps during the operation. Only after the current step is completed and confirmed to be correct is the next operation allowed, ensuring that the operation complies with clinical standards.

[0036] Intraoperative Recording Module: This module integrates multimodal information acquisition technology, enabling medical staff to efficiently record the following intraoperative information: ① Real-time acquisition and recording of key surgical information, including intraoperative medication records (automatically linked to the drug database, supporting initial letter search), patient vital signs data (supports data interface with monitors, automatically synchronizing heart rate, blood pressure, and blood oxygen saturation), and operation time nodes (automatically generated time, accurate to the second); ② Support for surgical consumables UDI code recognition (compatible with barcodes / QR codes, recognition speed ≤ 1 second). 1) Automatically associates consumable information (model, specifications, manufacturer, expiration date) and enters it into the system to avoid manual input errors; 2) Provides a photo archiving function for key surgical steps (supports high-definition shooting, resolution ≥1080P), which can take photos to record the instrument placement status, operation interface parameters, etc., and automatically associate them with the corresponding operation nodes; 3) Provides an electronic signature confirmation function for key surgical nodes, where medical staff can complete electronic signatures through fingerprint / facial recognition at key nodes (such as completion of preoperative preparation, completion of preoperative verification, and confirmation of the end of surgery), ensuring the authenticity and legal validity of the record. At the same time, the signature information is bound to the operation record in real time to form a traceable operation chain.

[0037] Data Synchronization Module: This module uses edge-cloud collaboration technology and encrypted transmission protocols to encrypt and synchronize the execution data generated throughout the entire surgical process (including task execution time, operation location information, node operation results, and record files) to the cloud server in real time, with a synchronization delay of ≤3 seconds. It also supports a network outage buffering function, which automatically caches data when the network is interrupted and automatically retransmits it after the network is restored, ensuring the timeliness and integrity of the data and providing an accurate data foundation for subsequent surgical quality assessment and cost accounting.

[0038] The patient-side app focuses on the needs of patients during the pre-operative preparation and post-operative rehabilitation stages of interventional surgery. It assists patients in completing the entire cycle of care through multimedia interaction technology and specifically includes the following functional modules:

[0039] Preoperative preparation guidance module: This module is based on a patient-specific preoperative preparation checklist (customized according to the patient's surgical type and underlying diseases) distributed from a cloud server. It guides patients to perform preoperative preparation tasks through multiple media: ① It uses voice broadcast (supporting adjustable speech speed and dialect versions) to remind patients to complete preparations according to the time nodes (such as fasting for 8 hours before surgery and abstaining from water for 2 hours before surgery); ② It guides patients to complete personal preparations (such as cleaning the surgical site and changing into surgical gowns) through step-by-step picture instructions (including operation diagrams and precautions); ③ It provides demonstration videos of preoperative examination items (including examination procedures and key points of cooperation) to help patients understand the purpose of the examination and the operation method, avoiding omissions or operational errors due to information discrepancies.

[0040] Postoperative Rehabilitation Guidance Module: This module, based on the patient's postoperative recovery stage (e.g., 1-3 days post-surgery, 1 week post-surgery, 1 month post-surgery) and surgical type, pushes personalized postoperative rehabilitation guidance plans to patients via a cloud server: ① Guides patients to conduct rehabilitation exercises (e.g., limb movement training, respiratory function training) through illustrated tutorials (including movement breakdown diagrams and key points of exertion) and dynamic video demonstrations (supporting playback speed adjustment and highlighting key areas); ② Provides a dietary recommendation list (including recommended foods, prohibited foods, and nutritional balance plans), and supports adjusting the recommendations according to the patient's dietary preferences; ③ Clarifies wound care requirements (e.g., dressing frequency, disinfection methods, and identification of abnormal symptoms), while also indicating follow-up appointment times, follow-up items (including examination types and appointment methods), and postoperative emergency handling methods (e.g., medical guidance for bleeding or increased pain), assisting patients in scientific recovery and improving postoperative rehabilitation outcomes.

[0041] The robot is an intelligent execution device specifically designed for interventional catheterization labs. It achieves collaboration with a cloud server and dual-device mobile apps through hardware configuration and software algorithms. Specific technical features and functionalities are as follows:

[0042] (1) Robot deployment scenarios and core basic capabilities

[0043] This robot is specifically deployed in the catheterization lab of interventional surgery. Its hardware configuration and software system are adapted to the medical environment requirements of the catheterization lab (such as resistance to electromagnetic interference and radiation protection). It has three core basic technical capabilities: ① Autonomous mobility: Equipped with lidar and a visual navigation module, it supports autonomous movement within the catheterization lab along a preset path (movement accuracy ≤0.3m) and can precisely stop in designated areas (such as next to the operating table or instrument cabinet) according to surgical needs; ② Environmental and information perception capabilities: Equipped with a high-definition camera (resolution ≥4K), infrared sensor, and temperature and humidity sensor, it can capture surgical environment data (such as room temperature and humidity), key intraoperative operation scenarios (such as consumable retrieval and drug injection), and equipment status (such as monitor parameters and surgical instrument positions) in real time; ③ Human-computer interaction capabilities: It integrates a touch screen and a voice interaction module (supporting medical terminology recognition) and can interact with medical staff (such as receiving operation instructions and providing feedback on task execution results). Meanwhile, the robot supports dual-mode network access via WiFi and 5G, with a network transmission rate of ≥100Mbps. It can act as a communication hub to establish real-time data interaction links with the cloud server and the app. On one hand, it can dynamically report its task execution status (such as the number of completed checks and the list of tasks to be executed) to the cloud server and the app. On the other hand, when abnormal situations are detected (such as network interruption, insufficient power, or task execution deviation), it automatically triggers an audible and visual warning mechanism (flashing red light + buzzer alert) and simultaneously pushes abnormal alarm information to the cloud and the app, ensuring the real-time and reliable transmission of surgery-related information. As a specific implementation, the robot can be implemented using the Cruzr robot developed by UBTECH Robotics Corp.

[0044] (2) Implementation of core functions of the robot

[0045] Based on the above fundamental capabilities, the robot achieves the following three core functions through its own software algorithms:

[0046] Remote control and parameter configuration functions: Medical staff can remotely control the robot and set parameters via a medical staff app, including: ① Movement path planning: After drawing the movement path in the catheterization lab on the medical staff app, the robot automatically executes the path planning and moves through the navigation module; ② Task start / pause control: The robot's verification tasks, recording tasks, and other operations can be started or paused remotely; ③ System parameter configuration, including AI recognition accuracy thresholds (e.g., UDI code recognition confidence level of consumables ≥90%) and warning trigger conditions (e.g., low battery warning triggered when battery level is below 15%, network warning triggered when data synchronization delay exceeds 5 seconds), eliminating the need for on-site operation by medical staff and improving the robot's ease of use and operational flexibility.

[0047] Automated Surgical Processing Function: After loading the standardized interventional surgery process issued by the cloud server, the robot automatically executes the following three core tasks: ① Verification of key surgical nodes: Following the preset process, the robot sequentially completes preoperative preparation verification (such as confirmation of instrument sterilization status and patient identity verification), pre-puncture / general anesthesia verification (such as confirmation of allergy history and verification of anesthesia plan), verification of key intraoperative operation nodes (such as confirmation of secondary surgery communication records and verification of emergency medication), and post-operative verification (such as instrument counting and patient vital sign recording). During the verification process, the robot provides voice prompts for medical staff to confirm; if no confirmation is received, the robot will not proceed to the next step. ② Full-process surgical supervision: The robot monitors whether the medical staff's operations comply with the standards through a visual recognition module (such as whether consumables are recorded and medication injections are verified). Real-time warnings are triggered when violations are detected. ③ Recording of information for each stage of the surgery: The robot automatically records the completion time, personnel involved, and verification results of each stage, forming a structured surgical log.

[0048] Intraoperative Information Intelligent Collection and Upload Function: The robot, through its built-in AI voice recognition and AI image recognition modules, achieves automated collection and upload of intraoperative information: ① The AI ​​voice recognition module recognizes the intraoperative instructions (such as "use heparin sodium", "change guidewire") and operation descriptions from medical staff, automatically extracting information such as drug name, dosage, and consumable type; ② The built-in AI image recognition module recognizes intraoperative drug packaging (supports drug name and specification recognition), consumable UDI codes, and patient vital signs monitor screen data (supports heart rate, blood pressure, and blood oxygen saturation value recognition), accurately extracting structured information; ③ The collected information is encrypted and uploaded to the cloud server in real time with an upload delay of ≤2 seconds, and simultaneously synchronized to the medical staff's APP, realizing full-process digital management of interventional surgery from preoperative preparation to intraoperative operation, significantly reducing the workload of manual recording, and improving the safety, standardization, and efficiency of surgical operations.

[0049] To more clearly illustrate the technical solution of the interventional surgery safety management system provided by the present invention, and to facilitate comparison with the technical defects of the prior art, a detailed description will be provided below in conjunction with specific embodiments.

[0050] This embodiment uses "coronary angiography + stent implantation when necessary" as a typical application scenario to verify the technical feasibility and effectiveness of the interventional surgery safety management system of this invention. Its technical solution is also applicable to other interventional surgeries such as cerebrovascular interventional surgery and peripheral vascular interventional surgery. This embodiment is based on the collaboration of a cloud server, a mobile application (hereinafter referred to as "APP"), and a catheterization lab robot to achieve full-process safety management of the surgery "preoperative-intraoperative-postoperative". The functions of each link and the technical capabilities of the system components are strictly matched. The specific implementation process is detailed in the appendix. Figures 1-5 Expand.

[0051] (I) Preoperative safety preparation and risk assessment stage (from the time the surgical order is issued by the HIS system to the start of the surgery). The core objective of this stage is to complete the configuration of the preoperative safety checklist, information verification and environmental preparation through cloud server data integration, APP multi-role collaboration and robot scenario deployment, so as to eliminate potential preoperative risks.

[0052] 1.1 Standard security inventory cloud configuration and personalized generation

[0053] (1) Standard list preset

[0054] The cloud server's "Data Storage and Analysis Module" pre-stores the "List of Safety Management Standards for Coronary Artery Stent Implantation." This list is constructed based on industry standards such as the "Management Specifications for Cardiovascular Interventional Diagnosis and Treatment Techniques" and the "Medical Quality Management Measures," covering several safety verification benchmarks in four major categories, as detailed below:

[0055] Patient information verification items include: patient name, hospital number, gender, date of birth, type of surgery, preoperative diagnosis (e.g., "acute inferior wall myocardial infarction"), and informed consent form signing status;

[0056] Preoperative examination confirmation items include: 12-lead electrocardiogram, coagulation function (INR value 0.8-1.5, APTT value 25-35s), liver and kidney function, history of contrast agent allergy, infectious disease screening (hepatitis B / hepatitis C / syphilis / HIV), echocardiogram report, myocardial enzyme spectrum, and electrolytes;

[0057] Medical device and consumable compliance items include: stent model, guidewire / balloon model, expiration date of each consumable (≥3 months from the date of use), integrity of consumable packaging, contrast agent batch number, heparin specification (12500U / vial), expiration date of emergency medicines (atropine, adrenaline, etc.), and preparation of emergency life support equipment, etc.

[0058] Personnel qualifications include: surgeon / radiologist / nurse's professional qualification certificate number, interventional diagnosis and treatment technology authorization level, cardiopulmonary resuscitation training qualification record, defibrillation operation assessment results, angiography machine operation qualification, and consumable verification and training certificate.

[0059] (2) Dynamic generation of personalized lists

[0060] After the surgeon issues the order for "coronary angiography + stent implantation if necessary" in the HIS system, the "external system integration module" on the cloud server interacts with the HIS system in real time through the interface protocol, synchronizing the following information:

[0061] Patient basic information: name, gender, date of birth, medical record number, diagnosis "acute inferior wall myocardial infarction", past medical history "contrast agent allergy (2020)";

[0062] Surgical procedure information: Coronary angiography + stent implantation.

[0063] The cloud server's "Business Logic and Service Module" calls the built-in "Surgical Safety Knowledge Base" and performs intelligent matching based on the above information: because the patient has a "history of contrast agent allergy", the system automatically adds two personalized safety items: "Confirmation of preparation for anti-allergy drugs (dexamethasone 5mg)" and "Registration of alternative low-osmolarity contrast agents". Finally, a "Patient-Specific Surgical Safety Task List" is generated, and each task execution subject (such as "Attending Physician - Preoperative Examination Verification", "Ward Nurse Preoperative Preparation Confirmation", "Interventional Room Nurse Preparation Confirmation") and completion time limit (such as "Complete Examination Verification 30 minutes before operation" and "Complete Consumable Preparation 20 minutes before operation").

[0064] 1.2 Multi-role App Collaborative Verification and Information Synchronization

[0065] The app assigns tasks based on role permissions, and all operation data is encrypted and uploaded to the cloud server through the "data synchronization module" to achieve real-time information sharing.

[0066] (1) Medical staff operation (4 types of role collaboration)

[0067] Attending physician: Log in to the "Preoperative Examination Verification" module of the APP, link the results of the examinations that need to be screened before surgery in the patient's HIS system, such as the patient's 12-lead electrocardiogram, coagulation function report, etc. The system automatically compares with the standard threshold and marks "Verification Passed"; take a photo and upload the signed pages of the "Surgical Informed Consent Form" and "Power of Attorney", etc. The APP uses OCR recognition technology to verify the integrity of the signature (requires the signature of both patient / family member and doctor) and the consistency of the name (matching with the patient information database).

[0068] Surgeon: Log in to the "Surgical Plan Confirmation" module of the APP, view the "Tomorrow's Surgery List", click on the target patient to complete the preoperative visit record: including condition assessment ("Chest pain lasting 4 hours, NSTEMI classification"), consumable matching confirmation ("2.5mm stent matches target vessel diameter"), special preparation notes ("Right coronary artery occlusion, temporary pacemaker required"). The record is automatically synchronized to the cloud for the team to view.

[0069] Ward nurses: Log in to the "Patient Preoperative Preparation" module of the APP and perform three core operations: ① Take a photo of the patient's wristband, use OCR to identify the name / hospital number and compare it with the information in the cloud (confirm that there is no mismatch); ② Push preoperative education content ("6 hours of fasting before surgery, 2 hours of water restriction, skin cleaning (right radial artery area)"), and record the education process; ③ Mark "indwelling intravenous catheter (18G, right forearm)" and "300mg aspirin taken before surgery (2 hours before surgery)", and upload the operation time.

[0070] Interventional unit nurses: Log in to the "Catheterization Lab Preparation" module of the APP, check and upload: ① Equipment status (DSA angiography machine on standby, defibrillator battery at 100%, temporary pacemaker on standby, etc.); ② Consumable UDI code scan (stent, guidewire, balloon, etc.); ③ Drug list (contrast agent, 500ml normal saline, 12500U heparin, dexamethasone, etc.).

[0071] (2) Patient-side operation

[0072] The patient logs into the "Preoperative Preparation" module of the APP and completes: ① Filling out the "Preoperative Allergy History Questionnaire" (checking "Contrast agent allergy" and "No drug / food allergy"); ② Uploading a preoperative skin preparation photo (no damage to the right radial artery area, no catheter, no fistula, no jewelry, etc.) and confirming the wearing of surgical gowns; ③ Confirming the signing status of the "Surgical Informed Consent Form" and "Consumable Selection Confirmation Form"; After the system verifies that all items are "complete", it pushes the surgical process animation ("Patient enters the room → Preparation → Disinfection → Puncture → Angiography → Stent Implantation") and sets dual reminders (voice + pop-up window) 2 hours and 30 minutes before the operation.

[0073] 1.3 Preoperative Deployment of Robots

[0074] The cloud server synchronizes the following information to the catheterization lab robot, which then completes its deployment through its "autonomous movement" and "environmental perception" capabilities:

[0075] Spatial configuration: Patient entry route (ward → catheterization lab operating table, avoiding equipment access), and checkpoint locations (catheterization lab entrance, operating table).

[0076] Function configuration: Preloaded "preoperative confirmation voice script" ("Please show your wristband for verification" "Do not cross the sterile area"), abnormal alarm threshold (heart rate > 120 beats / min, blood pressure < 90 / 60 mmHg triggers warning).

[0077] The robot moves to the "patient entrance" and activates the environmental perception module: ① Detects temperature and humidity (22℃, 50%, in compliance with the "Technical Specifications for Clean Operating Room Buildings in Hospitals"); ② Visually identifies the sterile area division (sterile cloth coverage area, warning sign location) to confirm that no personnel have violated regulations by crossing over; ③ Detects the attire of team members (surgical gowns, masks, and caps are worn in compliance with regulations); generates a "Preoperative Environmental Safety Report for the Catheterization Lab" and uploads it to the cloud in real time, awaiting the start of surgery instructions.

[0078] (II) Intraoperative safety monitoring and dynamic intervention phase (from the start to the end of the operation)

[0079] This phase utilizes robotic mandatory verification, cloud-based anomaly alerts, and app-based supplementary recording to achieve control over key intraoperative points and real-time risk intervention, as detailed in the attached document. Figures 1-4 The system's collaborative functions.

[0080] 2.1 Mandatory Verification of Key Nodes in Robot-Mediated Systems

[0081] After receiving the "surgery start command" from the cloud, the robot triggers four core node checks according to the "Patient-Specific Surgical Safety Task List". If the checks fail, the process is locked.

[0082] (1) Node 1: Patient identity verification upon arrival

[0083] The robot moves to the operating table: ① Voice prompt "Please verify patient information"; ② The screen displays the patient's name, hospital number, surgery name, and site; ③ The surgeon / nurse enters their employee ID, and the system verifies their qualifications (confirming that the surgeon has "Level III authorization for coronary intervention"); ④ The wristband is scanned to compare information; After all roles confirm, an "verification passed" electronic record is generated, allowing the surgery to begin.

[0084] (2) Node 2: Time-out check before puncture

[0085] The robot forcibly pauses operation: ① Voice announcement "Entering Time-out verification"; ② Screen displays core items (patient identity confirmed, surgery type unchanged, right radial artery puncture site (marked), allergy history medication prepared, emergency equipment on standby); ③ Requires 3 people (surgeon / nurse / radiologist) to click "confirm"; The verification time (down to the second) and employee ID are recorded in the cloud, generating an unalterable "Time-out Verification Record File".

[0086] (3) Node 3: Pre-implantation verification of stents

[0087] The robot moves to the instrument table: ① Scans the stent's UDI code, verifies the model and expiration date in the cloud; ② AI image recognition shows the integrity of the packaging; ③ Voice prompt "Please confirm the stent model", the surgeon confirms by voice or click; if the model is mismatched, the robot immediately sounds an alarm (red light flashing + "model mismatch" voice), pushes a warning to the cloud and the doctor's APP, and locks the operation until the correct stent is replaced.

[0088] Node 4: Post-operative departure verification

[0089] The robot triggers the exit verification: ① The screen displays patient information, a list of consumables used (1 stent, 1 guidewire, 1 balloon), and a list of medications used (6000U heparin, 5mg dexamethasone); ② The nurse verifies the actual usage and clicks "Confirm"; a "Surgery End Verification Record" is generated, allowing the patient to leave the catheterization lab.

[0090] 2.2 Intraoperative real-time data monitoring and early warning of abnormalities

[0091] (1) Robot data acquisition

[0092] The robot wirelessly connects to the monitor to collect in real time: ① vital signs; ② operational data (puncture time, contrast agent dosage, stent implantation time, etc.); AI voice recognition records "intravenous injection of heparin 6000U" and "replacement of 1 guidewire", generating an "Intraoperative Safety Record Form" and synchronizing it to the cloud via 5G.

[0093] (2) Cloud-based early warning and intervention

[0094] The cloud-based system presets safety thresholds (heart rate 50-100 beats / min, blood pressure 90-140 / 60-90 mmHg) and analyzes data in real time: ① When the patient's heart rate drops to 45 beats / min due to puncture stimulation, the cloud identifies the abnormality within 5 seconds and triggers an alert; ② Simultaneously pushes a "low heart rate alert" to the robot (voice broadcast) and the doctor's APP (pop-up window, including "recommended intravenous administration of atropine 0.5mg"); ③ The robot screen displays "Atropine location (second slot on the left side of the instrument table)" to assist the nurse in retrieving the medication; 5 minutes after the intervention (14:30), the heart rate rises back to 65 beats / min, and the cloud records "intervention measures, time, and effect," forming a closed loop.

[0095] 2.3 Intraoperative safety recording and traceability (APP + robot collaboration)

[0096] Robotic recording: Automatically stores the time of each node (such as puncture, stent implantation, etc.), early warning and treatment process, vital sign curves, and uploads them to the cloud in real time;

[0097] Supplementary records from the app: The nurse uploaded the following records through the "Intraoperative Record" module of the app: "No bleeding at the right radial artery puncture site" and "Contrast agent dosage 100ml (not exceeding the 400ml safety limit)";

[0098] Doctor Confirmation: The surgeon signs the "Intraoperative Procedure Confirmation Form" through the APP to confirm the surgical outcome; all records form an "Intraoperative Safety Data Chain" and are stored in the cloud for traceability.

[0099] (III) Closed-loop stage of postoperative safety management and follow-up (from the end of surgery to 1 year postoperatively)

[0100] This phase achieves a closed-loop postoperative management system through cloud-based data integration, APP-based rehabilitation guidance, and follow-up.

[0101] 3.1 Cloud-based postoperative data integration and analysis

[0102] After the surgery, the cloud automatically integrates preoperative and intraoperative data to generate the following types of structured reports:

[0103] Surgical Safety Compliance Report: 100% pass rate for preoperative, intraoperative, and postoperative checks;

[0104] Consumables Usage Statistics Table: 1 stent (manufacturer, model, expiration date, unique code, etc.), 1 guidewire (manufacturer, model, expiration date, unique code, etc.), 1 balloon (manufacturer, model, expiration date, unique code, etc.);

[0105] Intraoperative Nursing Record Sheet: Records of procedures such as wound dressing and nursing care, medication administration, etc.

[0106] The report is stored in the cloud and can be accessed by departmental quality control personnel with the appropriate permissions for safety and quality assessment.

[0107] 3.2 Patient-side APP rehabilitation guidance and feedback

[0108] Based on the patient's surgery type and recovery stage (same day after surgery, 2-7 days after surgery, 1-3 months after surgery, 3-6 months after surgery, 6-12 months after surgery), the cloud server generates a personalized rehabilitation safety checklist, which is then pushed to the patient's end. The checklist content for each recovery stage is as follows:

[0109] Post-operative care: Puncture site care (avoid pressing, observe for bleeding / swelling); drink plenty of water (2000ml / day to promote contrast agent excretion); antiplatelet medication reminder (aspirin 100mg / day + clopidogrel 75mg / day, do not miss a dose);

[0110] Postoperative days 2-7: Suture removal time at the puncture site (7 days postoperatively); Activity guidance (walking for 30 minutes / day is allowed, avoid lifting heavy objects >5kg); Dietary guidance (low-fat, low-salt, avoid spicy foods);

[0111] 1-3 months post-surgery: Upgrade rehabilitation exercises (e.g., from slow walking to brisk walking, 40 minutes each time); Follow-up appointment reminders (ECG and coagulation function tests 1 month post-surgery);

[0112] Postoperative 3-12 months: Long-term medication management (do not stop medication on your own); recognition of abnormal symptoms (such as chest pain or difficulty breathing require immediate medical attention); annual follow-up (coronary angiography 1 year postoperatively);

[0113] Patients can complete the following operations through the patient-side app:

[0114] Feedback: Upload photos of the puncture site (e.g., no bleeding or swelling 3 days post-procedure) and confirm daily medication (click "I have taken aspirin").

[0115] Reporting abnormalities: If you experience "increased pain at the puncture site and redness of the skin", click the "Abnormal Feedback" button in the APP, upload a photo and describe the symptoms;

[0116] The system automatically verifies the feedback information: if it is in a normal recovery state, it marks "no abnormality" and synchronizes it to the cloud; if it is an abnormal situation, it triggers the "abnormal feedback channel" and pushes a reminder to the attending physician's APP and the nurse's APP within 10 minutes.

[0117] 3.3 Follow-up and intervention via medical staff's mobile app

[0118] Abnormal intervention: When a patient reports "redness and swelling at the puncture site," the attending physician can view the photos through the app, determine "mild local inflammation," and push a treatment plan.

[0119] Follow-up reminders: The system sets up a "postoperative follow-up schedule" task to automatically remind doctors to follow up on the patient's follow-up situation, check the follow-up results, and provide timely rehabilitation guidance, forming a closed-loop follow-up system.

[0120] Compared with existing technologies, the interventional surgery safety management system provided by this invention achieves automated process reminders and execution supervision of the entire interventional surgery process, automatic collection and recording of key diagnostic and treatment data during the operation, closed-loop management of intraoperative drug and consumable use, and personalized rehabilitation guidance for patients after the operation by combining the data processing capabilities of the cloud server, the convenient interactive functions of the dual-end mobile APP, and the on-site execution capabilities of the robot. Ultimately, it builds a complete safety management closed loop covering "pre-operative-intra-post-operative" between medical staff and patients, thereby ensuring the safety, compliance, and traceability of interventional surgery.

[0121] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. An interventional surgery safety management system, characterized in that, This includes a cloud server, two-sided mobile apps, and a robot, with each of these components interconnected. The cloud server includes an external system integration module, a business logic and service module, and a data storage and analysis module. The external system integration module achieves seamless integration with the hospital's existing information system based on a standardized interface protocol. It automatically extracts surgical orders, patient basic information, and diagnostic and treatment information, and performs preliminary screening and format conversion on the extracted unstructured data, providing standardized data input support for subsequent business module instruction generation and data analysis. The business logic and service module receives and processes standardized surgical and patient information data transmitted by the external system integration module, and receives surgical progress data uploaded by medical staff during surgery using AI voice recognition and AI image recognition technologies. It generates verification instructions that conform to interventional surgery clinical standards for these two types of data. The data storage and analysis module stores a standardized interventional surgery process knowledge base and all structured data generated during surgery. It performs structured analysis and classification archiving of the stored data and constructs a surgical experience knowledge base based on the analysis results. The dual-end mobile app includes a medical staff app and a patient app. The medical staff app is based on data distributed from a cloud server and real-time monitoring by a robot. It is used to provide medical staff with services including full-cycle surgical management, task execution guidance, real-time information recording, and encrypted data synchronization. The patient app is used to provide patients with preoperative preparation guidance based on a patient-specific preoperative preparation checklist distributed from the cloud server. It also pushes personalized postoperative rehabilitation guidance to patients through the cloud server based on the patient's surgical recovery stage and surgical type, assisting patients in completing full-cycle care. The robot is specifically deployed in the interventional surgery catheterization room to enable remote control and parameter configuration, automated processing of surgical procedures, and intelligent collection and uploading of intraoperative information to the cloud server and the medical staff's mobile app.

2. The interventional surgery safety management system according to claim 1, characterized in that, The business logic and service module generates verification instructions that conform to the clinical standards of interventional surgery for the above two types of data by: firstly, completing data feature extraction and weight calculation through a preset dynamic feature extraction algorithm; secondly, comparing the data with the system's built-in surgical standard knowledge base in multiple dimensions; and finally, using a multi-objective optimization algorithm to generate verification instructions that conform to the clinical standards of interventional surgery.

3. The interventional surgery safety management system according to claim 1, characterized in that, The data storage and analysis module stores a standardized interventional surgery procedure knowledge base, covering the entire process, including preoperative preparation, catheterization lab preparation, pre-puncture / general anesthesia check, key intraoperative operation nodes, and postoperative check. Each step includes a corresponding standardized task list and operational risk warnings. The data storage and analysis module also stores all structured data generated during the surgical procedure, including the patient's entire surgical procedure log, intraoperative consumable usage details, and intraoperative medication usage records.

4. The interventional surgery safety management system according to claim 1, characterized in that, The medical staff-side APP includes a remote management and monitoring module, a surgical task execution module, an intraoperative recording module, and a data synchronization module. The remote management and monitoring module synchronizes data based on a cloud server, supporting medical staff to remotely configure surgical plan parameters, monitor robot operation status, and view the progress of the entire surgical process. It also receives abnormal alarm information pushed by the system and supports access to historical surgical records. The surgical task execution module receives surgical arrangement information from the cloud server in real time and accurately pushes it to the corresponding medical staff based on role permissions. During the surgical execution, it guides medical staff to complete the operation step by step according to the preset standardized process through interactive methods. The intraoperative recording module supports medical staff to collect and record key surgical information in real time, identify and associate surgical consumables UDI codes, archive key surgical steps by photo, and confirm key surgical nodes with electronic signatures. The data synchronization module is used to encrypt and synchronize the execution data generated throughout the surgical process to the cloud server in real time, and also supports offline buffering function.

5. The interventional surgery safety management system according to claim 1, characterized in that, The robot is used to achieve remote control and parameter configuration functions, including supporting medical personnel to remotely complete the robot's movement path planning, task start / pause control, and system parameter configuration through a medical personnel-side APP.

6. The interventional surgery safety management system according to claim 1, characterized in that, The robot is used to automate the surgical process, including: after loading the standardized interventional surgery process issued by the cloud server, the robot automatically performs key surgical node checks, full surgical process supervision, and information recording of each stage of the surgery.

7. The interventional surgery safety management system according to claim 1, characterized in that, The robot is used to intelligently collect and upload intraoperative information, including: using its built-in AI voice recognition module to recognize the intraoperative instructions and operation descriptions of medical staff, and automatically extracting information such as drug names, dosages, and consumable types; and using its built-in AI image recognition module to recognize intraoperative drug packaging, consumable UDI codes, and patient vital signs monitor screen data, and accurately extract structured information; and then encrypting and uploading the collected information to the cloud server in real time, while simultaneously synchronizing it to the medical staff's mobile app.

Images