A midline conduit with intelligent navigation function and its system

Abstract

This invention discloses a midline catheter and its system with intelligent navigation function, belonging to the field of medical device technology. The system includes a catheter integrating miniature electromagnetic and pressure sensors, an external positioning device, and a processing and display unit. By acquiring the three-dimensional position of the catheter tip and the contact pressure with the catheter wall in real time, and fusing it with a vascular model reconstructed from the patient's preoperative images, a real-time interactive three-dimensional navigation screen is formed, guiding the operator to accurately place the catheter tip into the target area of ​​the superior vena cava. This invention achieves visualization and intelligentization of the midline catheter placement process, effectively avoiding accidental entry into branches and damage to blood vessels, significantly improving the success rate of first-time catheter placement and operational safety.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to a midline catheter and its system with intelligent navigation function. Background Technology

[0002] A midline catheter is a central vascular access device inserted via peripheral venous puncture, with its tip located at the periphery of the wall of the subclavian, axillary, or brachial vein. Compared to traditional peripheral intravenous catheters, it can tolerate longer drug infusion times; compared to central venous catheters, it is easier to insert and has a lower risk of complications. Therefore, its use is becoming increasingly widespread in moderate-duration intravenous therapy.

[0003] However, current midline catheter placement generally relies on traditional surface anatomical marking and ultrasound guidance. While the operator can visualize the punctured vein using ultrasound, the catheter's path after entry into the vessel and the final position of its tip cannot be visualized in real time. Whether the tip is located in an ideal area with abundant blood flow and a large diameter can only be confirmed through postoperative chest X-rays. This leads to a series of clinical problems: The success rate of catheter placement is unstable: the catheter is easily misplaced into other branches such as the internal jugular vein, requiring repeated adjustments or even re-insertion if it fails.

[0004] Complication risks: Blindly pushing the tip may damage the vascular endothelium, increasing the risk of phlebitis and thrombosis. Poor tip placement can lead to functional impairment or arrhythmia.

[0005] Inefficient and experience-dependent: The entire process is full of uncertainties, highly dependent on the operator's experience, and requires multiple X-ray exposures for confirmation, making the process cumbersome.

[0006] Therefore, there is an urgent clinical need for a midline catheter technology that can achieve real-time visualization and intelligent navigation during the catheterization process to improve the accuracy, safety and efficiency of catheterization. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the prior art and provide a centerline duct and its system with intelligent navigation function.

[0008] To achieve the above objectives, the present invention provides the following technical solution: This application provides a midline catheter with intelligent navigation function, including a catheter body, the distal end of which is integrated with a miniature sensor module for real-time sensing of position and / or mechanical state information.

[0009] Optionally, the micro-sensor module includes at least one of an electromagnetic sensor and a micro-pressure sensor; the electromagnetic sensor is used to generate a position signal under the induction of an external magnetic field; the micro-pressure sensor is attached to the outer wall of the catheter body and is used to sense the contact pressure between the catheter tip and the blood vessel wall.

[0010] Optionally, the catheter body has embedded microwires electrically connected to the microsensor module, and the microwires extend along the catheter wall to a connector interface at the proximal end.

[0011] Secondly, this application provides a midline conduit system with intelligent navigation function, comprising: As mentioned above, a centerline conduit with intelligent navigation function; An external positioning and navigation device is used to interact with the micro-sensor module to obtain position signals and / or pressure signals at the catheter tip; The processing and display unit is communicatively connected to the external positioning and navigation device, and is used to receive the signal, register it with a pre-stored patient vascular model, and generate a navigation interface that includes the real-time position and orientation of the catheter tip.

[0012] Optionally, the external positioning and navigation device is an electromagnetic positioning generator that generates a weak magnetic field with a known spatial distribution; the micro-sensor module is an electromagnetic sensor coil.

[0013] Optionally, the processing display unit includes: The image registration module is used to spatially register the real-time acquired catheter tip coordinates with the patient's preoperative or intraoperative medical imaging data. The navigation algorithm module has a built-in vascular centerline path planning algorithm, which is used to calculate and display the expected catheter travel path; The warning module is used to issue a visual or audible warning signal when the pressure value returned by the miniature pressure sensor exceeds a set threshold, or when the position of the catheter tip deviates from the predetermined path.

[0014] Optionally, the navigation interface may also display: a three-dimensional vascular model based on medical image reconstruction, real-time position and orientation icons of the catheter tip, a preset ideal catheter placement target area, and real-time pressure oscilloscope waveforms or values.

[0015] Optionally, the system also includes a portable handheld terminal, which is wirelessly connected to the processing and display unit to display simplified navigation information for convenient viewing by the operator outside the bedside sterile area.

[0016] Thirdly, this application provides a method for intelligent navigation placement of a midline catheter using the system described above, comprising the following steps: S1: Acquire medical images of the patient's chest vessels, construct a personalized three-dimensional vascular model of the superior vena cava, and mark the target navigation area; S2: Establish the spatial coordinate mapping relationship between the external positioning and navigation device and the patient's body surface; S3: Insert the catheter under aseptic conditions and observe the catheter tip's position and pressure feedback in the vascular model in real time through the processing and display unit; S4: Following the navigation guidance, adjust the catheter tip and finally place it into the target navigation area. After confirmation, fix the catheter in place.

[0017] Optionally, in step S3, the operator avoids forceful pushing based on pressure feedback and identifies and corrects cases where the catheter is mistakenly inserted into a branch blood vessel based on location information.

[0018] Compared with the prior art, this application has the following beneficial effects: Transforming blind puncture and delivery into visual driving can intuitively avoid catheters entering branches, ensure accurate arrival at the target area on the first attempt, and significantly improve the success rate of first catheter placement.

[0019] Real-time pressure feedback acts like a tactile warning, reminding the operator to handle the vein gently and avoid mechanical injury. Precise tip positioning also eliminates complications related to malposition.

[0020] It reduces the extreme reliance on the surgeon's touch and experience, decreases the number of times ultrasound and X-rays are used for repeated confirmation, shortens the overall operation time, and makes the technology easier to standardize and promote.

[0021] It allows for immediate confirmation of catheter placement, eliminating the need to wait for postoperative X-rays, simplifying the workflow and facilitating rapid treatment for patients. Attached Figure Description

[0022] Figure 1 This is a flowchart of the intelligent navigation midline catheter placement method of the present invention.

[0023] Figure 2 This is a block diagram of a centerline conduit system with intelligent navigation function according to the present invention.

[0024] Figure 3 This schematic diagram illustrates the composition of an electronic device according to an exemplary embodiment of the present disclosure.

[0025] Figure 4 The schematic diagram illustrates the composition of a storage medium in an exemplary embodiment of the present disclosure. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Furthermore, in this invention, an element referred to as fixed to or disposed on another element may be directly disposed on the other element, or there may be an intermediate element. When an element is considered to be connected to another element, it may be directly connected to the other element, or there may be an intermediate element present simultaneously. The terms vertical, horizontal, left, right, and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0028] This application provides a midline catheter with intelligent navigation function, including a catheter body, the distal end of which is integrated with a miniature sensor module for real-time sensing of position and / or mechanical state information.

[0029] The micro-sensor module specifically includes a micro-triaxial accelerometer, a triaxial gyroscope, and a triaxial magnetometer. These three components work together to achieve real-time acquisition of six-degree-of-freedom attitude and position information of the distal end of the catheter within the human body. The accelerometer detects linear acceleration during catheter movement, the gyroscope measures angular velocity to reflect rotational state, and the magnetometer senses the strength and direction of the Earth's magnetic field to assist in correcting heading angle drift. The data from these three components are fused using a Kalman filter algorithm to output position coordinates with centimeter-level positioning accuracy and attitude angle information with an error within 0.5 degrees. Simultaneously, the sensor module also integrates a micro-pressure sensor, capable of real-time monitoring of the contact pressure between the distal end of the catheter and the blood vessel wall. When the pressure exceeds a preset safety threshold (e.g., 15 mmHg), an early warning signal is immediately triggered, effectively preventing mechanical damage to the vascular endothelium during catheter advancement. The sensor module is packaged using biocompatible polyimide material with a thickness controlled within 0.3 mm and a diameter not exceeding 1 / 3 of the outer diameter of the catheter body, ensuring that it does not significantly increase the flexibility and permeability of the catheter. Its lead is connected to the signal interface at the proximal end through a dedicated microchannel in the inner cavity of the catheter body, realizing bidirectional data transmission with the external control console.

[0030] In one specific embodiment, the micro-sensor module includes at least one of an electromagnetic sensor and a micro-pressure sensor; the electromagnetic sensor is used to generate a position signal under the induction of an external magnetic field; the micro-pressure sensor is attached to the outer wall of the catheter body and is used to sense the contact pressure between the catheter tip and the blood vessel wall.

[0031] For example, the electromagnetic sensor can employ a triaxial miniature electromagnetic induction coil, working in conjunction with an externally positioned low-frequency alternating magnetic field generator to generate a three-dimensional spatial position signal at the catheter tip by sensing changes in the intensity and direction of the magnetic field. Preferably, 2-3 miniature pressure sensors are evenly distributed around the circumference of the catheter tip to comprehensively capture contact pressure with the blood vessel wall from different directions. Their sensing sensitivity can reach 0.1 mmHg. When the detected pressure value exceeds a preset safety threshold of 15 mmHg, an abnormal pressure signal can be immediately transmitted to the external control console via a dedicated lead, triggering an audible and visual warning to prompt the operator to adjust the propulsion force. The core components of the sensor module are all encapsulated in biocompatible polyimide material, with an overall thickness of [missing information]. The accuracy is controlled within 0.3mm, and the diameter does not exceed 1 / 3 of the outer diameter of the catheter body, effectively avoiding the impact on the original flexibility and vascular permeability of the catheter. The signal lead of the module uses ultra-fine platinum-iridium alloy wire with a diameter of only 0.05mm. It runs through an independent micro-channel in the inner cavity of the catheter body, which not only ensures the stability of data transmission, but also does not occupy the main channel space of the catheter used for drug infusion. In addition, the position signal collected by the electromagnetic sensor can be fused with the data of the inertial measurement unit built into the catheter, which includes a three-axis accelerometer, a three-axis gyroscope and a three-axis magnetometer, through Kalman filtering, to further improve the detection accuracy of the catheter tip position and attitude, so that the positioning error is controlled at the centimeter level and the attitude angle error is less than 0.5 degrees.

[0032] In one specific embodiment, the catheter body has embedded microwires electrically connected to the microsensor module, and the microwires extend along the catheter wall to a connector interface at the proximal end.

[0033] The connector interface features a snap-fit ​​design to prevent mis-mating, enabling quick and precise docking with the corresponding port on the external positioning and navigation console. Its internal contacts are gold-plated, effectively reducing contact resistance during signal transmission and ensuring that pressure, position, and attitude data collected by the micro-sensor module are transmitted to the console for processing in real time and without loss. Simultaneously, the interface is equipped with a waterproof sealing ring to prevent short circuits or signal interference caused by liquid infiltration during clinical operations, further enhancing the system's reliability and safety. Furthermore, the connector interface's dimensions are compatible with the standard interface of existing midline catheters, allowing for direct use without replacing existing clinical equipment, thus lowering the barrier to entry and reducing costs for clinical adoption.

[0034] Secondly, this application provides a midline conduit system 20 with intelligent navigation function, comprising: As mentioned above, a centerline conduit with intelligent navigation function; An external positioning and navigation device 210 is used to interact with the micro-sensor module to obtain position signals and / or pressure signals at the catheter tip; The processing and display unit 220 is communicatively connected to the external positioning and navigation device, and is used to receive the signal, register it with a pre-stored patient vascular model, and generate a navigation interface that includes the real-time position and orientation of the catheter tip.

[0035] The system stably transmits pressure, position, and attitude data collected by a micro-sensor module to an external positioning and navigation device 210 via micro-wires embedded in the catheter. This device integrates a low-noise amplifier and a high-speed data acquisition chip, enabling precise capture and real-time conversion of weak signals. The navigation software built into the processing and display unit 220 possesses multimodal image fusion capabilities, allowing for the overlay and registration of preoperative CT angiography images with real-time catheter position information during the procedure. This generates a three-dimensional visual navigation interface, clearly marking the relative position of the catheter tip within the blood vessel, its direction of travel, and surrounding important anatomical structures. It also supports touch-sensitive zoom and angle rotation, facilitating multi-view observation of the operating area by the physician. Furthermore, the system includes a data storage module that automatically records catheter dynamic parameters and navigation logs throughout the entire procedure, providing comprehensive data support for postoperative review and clinical research. All data is stored in an encrypted format to ensure patient privacy and security.

[0036] In one specific embodiment, the external positioning and navigation device is an electromagnetic positioning generator that generates a weak magnetic field with a known spatial distribution; the micro-sensor module is an electromagnetic sensor coil.

[0037] When the catheter moves within this weak magnetic field, the electromagnetic sensor coil generates an induced electromotive force (EMF) due to changes in the magnetic field. The signal characteristics of this EMF have a precise mathematical correspondence with the coil's three-dimensional position and spatial orientation. The external positioning and navigation device uses a built-in signal processing algorithm to filter, amplify, and demodulate the induced EMF signal. Combined with a preset magnetic field distribution parameter model, it can calculate the coordinate information and orientation angle of the miniature sensor module in real time, thereby accurately reconstructing the dynamic position trajectory of the catheter within the blood vessel. This electromagnetic positioning method has the advantage of strong anti-obstruction capability, requiring no reliance on optical vision. Even when the catheter is partially obstructed by the blood vessel wall or surrounding tissue, it maintains millimeter-level positioning accuracy, effectively meeting the stringent requirements for real-time and stable navigation during midline catheter placement, providing a reliable basis for physician decision-making.

[0038] In one specific embodiment, the processing and display unit includes: The image registration module 230 is used to spatially register the real-time acquired catheter tip coordinates with the patient's preoperative or intraoperative medical imaging data. The navigation algorithm module 240 has a built-in vascular centerline path planning algorithm, which is used to calculate and display the expected catheter travel path; The warning module 250 is used to issue a visual or audible warning signal when the pressure value returned by the miniature pressure sensor exceeds a set threshold, or when the position of the catheter tip deviates from a predetermined path.

[0039] The image registration module 230 is used to spatially register the real-time acquired catheter tip coordinates with the patient's preoperative or intraoperative medical imaging data (such as CT angiography and ultrasound images). Through a rigid registration algorithm based on vascular anatomical landmarks, it achieves precise mapping between the electromagnetic positioning coordinate system and the medical imaging coordinate system, ensuring a clear overlay of the catheter position on the image. The navigation algorithm module 240 incorporates a vascular centerline path planning algorithm to calculate and display the expected catheter travel path. It can also dynamically adjust the path based on the real-time dynamic position of the catheter tip, combined with changes in vessel diameter, branch nodes, and curvature information. The system updates the optimal path and marks key operation nodes (such as blood vessel bends and branch entrances) with operation prompts. The early warning module 250 is used to issue visual or audible warning signals when the pressure value returned by the miniature pressure sensor exceeds a threshold preset based on the patient's blood vessel elasticity, or when the catheter tip deviates from the predetermined path by more than ±2mm. When the pressure exceeds the limit, a red flashing icon is used in conjunction with an intermittent buzzer sound to indicate the problem. When the path deviation is slight (≤1mm), a yellow warning light is used to indicate the need for fine-tuning the direction. When the deviation is severe (>2mm), a continuous alarm is triggered and navigation guidance is paused until the doctor manually confirms the adjustment and resumes.

[0040] In one specific implementation, the navigation interface simultaneously displays: a three-dimensional vascular model based on medical image reconstruction, real-time position and orientation icons of the catheter tip, a preset ideal catheter placement target area, and real-time pressure oscilloscope waveforms or values.

[0041] The 3D vascular model uses semi-transparent volumetric rendering technology to clearly present the course, branches, and spatial relationship of the target blood vessel with surrounding tissues. Doctors can rotate, scale, and translate the model using a touch screen or an external mouse, flexibly focusing on areas of interest. The real-time position and orientation icons of the catheter tip are superimposed on the model as highlighted colored arrows. The arrow color is linked to the pressure status (blue for normal pressure, yellow for mild abnormality, and red for severe abnormality), and the arrow points precisely to match the actual direction of catheter travel. The preset ideal catheter placement target area is defined by a green dashed cube, with the diameter, depth, and blood flow velocity of the target blood vessel marked inside the box, making it easy for doctors to confirm the catheter placement endpoint. The real-time pressure oscilloscope waveform is displayed as a dynamic curve on the right side of the interface, with a sampling frequency of 10Hz. The current pressure value is automatically marked at the peak of the waveform. When the pressure changes suddenly (such as fluctuations exceeding 5 mmHg in a short period of time), the waveform area will automatically flash and a value change prompt box will pop up. In addition, a deviation statistics bar is set at the bottom of the interface, which calculates the three-dimensional spatial deviation value and direction angle between the catheter tip and the ideal path in real time. The deviation data is accurate to 0.1mm, providing doctors with a quantitative reference for adjusting the catheter posture.

[0042] In one embodiment, the system further includes a portable handheld terminal wirelessly connected to a processing and display unit for displaying simplified navigation information for convenient viewing by the operator outside the bedside sterile area.

[0043] This handheld terminal features a 5-inch high-definition anti-glare touchscreen, supporting simple operations such as single-finger zoom and two-finger panning, allowing for quick focusing on the catheter tip area. The display interface layout maintains logical consistency with the main control console, displaying key information including the catheter tip orientation in the form of a bright colored arrow, pressure status color-coded markers, key parameters such as the diameter and depth of the blood vessel in the ideal placement area, and real-time updates of three-dimensional spatial deviation values. It uses the low-power Bluetooth 5.0 protocol to establish a stable connection with the processing and display unit, with a transmission latency of less than 100ms, ensuring navigation information synchronization. A built-in 2000mAh lithium battery allows for continuous operation for over 8 hours on a full charge, meeting the needs of typical surgical procedures. When the main control console detects a sudden pressure change or a deviation exceeding a threshold, the handheld terminal simultaneously triggers an audible and visual alarm (buzzer alert + screen flashing) and displays a red warning box at the top of the interface, promptly alerting the operator to the abnormal situation. Furthermore, the terminal supports offline caching; in the event of a brief disconnection, it retains the navigation data for the most recent 10 seconds, automatically re-uploading it upon reconnection to ensure operational continuity.

[0044] Example 1: Intelligent centerline conduit system integrating electromagnetic and pressure sensing 1. Overall System Composition like Figure 1 As shown, the intelligent navigation centerline guide system 20 of this embodiment consists of three core parts: Intelligent midline catheter assembly: a single-use sterile medical device.

[0045] External positioning and navigation device 210: includes an electromagnetic positioning transmitter and a main unit, and is reusable.

[0046] Processing display unit 220: Typically a high-performance medical touch screen all-in-one machine, running dedicated navigation software.

[0047] 2. Detailed structure of the intelligent midline conduit The catheter body is made of biocompatible polyurethane material, and its length ranges from 15-25 cm to accommodate different patient body types. The catheter lumen is a standard channel used for infusion and guidewire passage.

[0048] The key innovation of this invention lies in its remote sensing module: Electromagnetic positioning sensor: This is a miniature, coreless triaxial induction coil encapsulated in biocompatible epoxy resin, fully embedded in the duct wall at a distance of 0.5-1.0 cm from the tip. Its diameter is less than 1.0 mm and its length is approximately 2.0 mm. This sensor can detect changes in the strength and direction of an external magnetic field.

[0049] The pressure sensing array consists of two miniature fiber Bragg grating (FBG) pressure sensors, which are symmetrically embedded in the outer surface of the conduit wall at a 180-degree angle, only 0.3 cm from the tip. Each FBG sensor measures approximately 0.5 mm x 0.5 mm. FBG sensors were chosen because of their immunity to electromagnetic interference, extremely small size, and high sensitivity.

[0050] Signal transmission lines consist of several insulated microalloy wires wound in a spiral pattern around the wall of the catheter lumen to enhance its resistance to bending. These wires transmit the electrical signals (electromagnetic sensors) or optical signals (FBG sensors, which require transmission via miniature optical fibers) from the sensor to the proximal end.

[0051] Proximal multi-function interface: This interface includes a standard Luer lock infusion port and an electro-optical composite signal interface. The composite interface connects to the system host via a disposable sterile cable.

[0052] 3. External Positioning and Navigation Control Console Electromagnetic positioning transmitter: This is a flexible pad containing multiple magnetic field transmitting coils arranged in a specific three-dimensional array. The transmitter generates a low-intensity alternating magnetic field (frequency range 5-20kHz) with a known spatial gradient. This magnetic field penetrates human tissue but does not interfere with the human body or the device. The transmitter connects to the host computer via USB or a dedicated cable.

[0053] Main unit: Internally includes a magnetic field generation circuit, a signal demodulation module, and a data preprocessing module. The main unit is responsible for driving the transmitter board and receiving raw signals from the duct sensor and optical signals from the FBG demodulator (integrated or external), converting them into digital position coordinates and pressure values.

[0054] 4. Processing and display unit and navigation software The core navigation software running in this unit includes the following modules: 3D Image Import and Modeling Module: Supports importing CT or MR venography data in DICOM format. The software uses region growing and centerline extraction algorithms to automatically or semi-automatically reconstruct personalized 3D vascular models from the puncture point (such as the basilic vein) to the superior vena cava (SVC) and right atrium (RA) entrance.

[0055] Image registration module 230: Before catheter placement begins, the operator uses a calibrated registered probe (with an electromagnetic sensor) to touch at least three anatomical landmarks on the patient's body surface (such as the suprasternal notch, the midpoint between the left and right clavicles). The software calculates and precisely registers the virtual 3D vascular model with the patient's actual anatomical space and the spatial coordinate system established by the electromagnetic positioning transmitter.

[0056] Navigation Algorithm Module 240: This is the core of the software. It receives catheter tip coordinates (x, y, z) and attitude angles (α, β, γ), as well as two pressure values ​​(P1, P2), from the host dozens of times per second. The engine maps this data to the 3D vascular model in real time.

[0057] User Interface (UI): The main UI view is a 3D rendered blood vessel model. The catheter tip is displayed as a dynamic cone-shaped icon with a short trajectory line at its tail. A semi-transparent blue tube represents the system-calculated recommended path. The target area (e.g., from the lower 1 / 3 of the SVC to 2cm above the RA inlet) is highlighted in green. The UI sidebar displays real-time pressure waveforms and values, as well as the distance of the catheter tip from the target area. When the average pressure value (P1+P2) / 2 exceeds a preset threshold (e.g., 15mmHg) or the catheter icon deviates from the recommended path by more than 2mm, the interface edge flashes red and emits a beeping alarm.

[0058] Data recording and reporting module: Automatically records the entire catheterization process, including the path, final tip position coordinates, maximum pressure value, etc., and generates a structured report that can be stored in the hospital information system.

[0059] 5. Detailed operating steps Step S1: Preoperative preparation.

[0060] A chest venography CT scan is performed on the patient, and the data is imported into the processing and display unit. The software generates a personalized 3D vascular model, on which the doctor confirms the puncture vein and target area.

[0061] Place the external positioning transmitter flat under the patient's torso on the operating table and connect it to the main unit. Turn on the entire system and perform a self-test.

[0062] Step S2: Patient localization and coordinate registration.

[0063] The patient lies supine on the operating table where the positioning plate has been placed.

[0064] The operator uses a registration probe wrapped in a sterile sleeve to sequentially touch predefined anatomical points on the patient's body surface. The software completes the spatial coordinate registration, and the screen displays a message indicating successful registration with an error of <1.5mm.

[0065] Step S3: Aseptic puncture and catheter connection.

[0066] The operator performs routine disinfection and draping, and then performs puncture and guidewire placement of the target peripheral vein under ultrasound guidance.

[0067] Remove the intelligent midline catheter and connect its proximal interface to the sterile receiving port extended from the host unit using a sterile connector. At this point, the catheter icon should immediately appear at the puncture initiation point on the vascular model displayed on the screen.

[0068] Step S4: Placement under real-time navigation.

[0069] The operator slowly pushes the catheter while watching the navigation screen. On the screen, the catheter icon moves along the blood vessel model in real time.

[0070] When the catheter is advanced to the junction of the axillary and subclavian veins, the system may predict the risk of accidental entry into the internal jugular vein based on the tip's posture, displaying a yellow arrow in advance to prompt the operator to slightly withdraw and rotate the catheter. The operator should adjust accordingly; if the pressure waveform remains stable, it indicates that the catheter has successfully entered the brachiocephalic vein.

[0071] Continue pushing, and when the catheter tip icon enters the target green area, the system emits a pleasant success beep. Simultaneously, the pressure sensor reading stabilizes at a low level (approximately 3-8 mmHg), consistent with the pulsating pressure characteristics of a central venous catheter.

[0072] Step S5: Confirmation and Completion.

[0073] The operator was able to draw blood smoothly through the catheter, further confirming that the position was good.

[0074] Click "Installation Complete" on the navigation software; the software will record the final coordinates. Remove the guidewire and connecting wires, connect the infusion tubing to the Luer lock interface, and suture to secure the catheter.

[0075] Example 2: A simplified system based on ultrasonic Doppler and impedance sensing A lower-cost, simplified alternative embodiment may be described herein, such as one in which a miniature Doppler ultrasound probe and electrodes are integrated at the catheter tip to indirectly determine location using blood flow velocity and electrocardiogram waveforms. The system then uses algorithms to fuse this information for assisted guidance. Its specific structure, signal processing method, and operation are similar to but simplified compared to Embodiment 1, in order to reflect the broad scope of the claims.

[0076] The advantages of the present invention are reflected in the embodiments: Through the above specific implementation methods, those skilled in the art can understand that the present invention transforms the abstract catheter placement operation into intuitive aerial navigation. Through multi-sensor fusion and augmented reality display, it provides operators with a see-through eye and tactile extension that surpasses traditional ultrasound, fundamentally solving the pain points of blind placement of midline catheters.

[0077] In an exemplary embodiment of this disclosure, an electronic device capable of implementing the above-described method is also provided.

[0078] Those skilled in the art will understand that various aspects of the present invention can be implemented as systems, methods, or program products. Therefore, various aspects of the present invention can be specifically implemented in the following forms: entirely in hardware, entirely in software (including firmware, microcode, etc.), or in a combination of hardware and software, collectively referred to herein as “circuit,” “module,” or “system.”

[0079] The following reference Figure 3 To describe an electronic device 300 according to this embodiment of the present invention. Figure 3 The electronic device 300 shown is merely an example and should not impose any limitations on the functionality and scope of use of the embodiments of the present invention.

[0080] like Figure 3 As shown, the electronic device 300 is presented in the form of a general-purpose computing device. The components of the electronic device 300 may include, but are not limited to: at least one processing unit 310, at least one storage unit 320, and a bus 330 connecting different system components (including storage unit 320 and processing unit 310).

[0081] The storage unit stores program code that can be executed by the processing unit 310, causing the processing unit 310 to perform the steps described in the "Exemplary Methods" section of this specification according to various exemplary embodiments of the present invention. For example, the processing unit 310 can perform actions such as... Figure 1S1: Acquire medical images of the patient's chest vessels, construct a personalized three-dimensional vascular model of the superior vena cava, and mark the target navigation area; S2: Establish the spatial coordinate mapping relationship between the external positioning and navigation device and the patient's body surface; S3: Insert the catheter under aseptic conditions, and observe the travel position and pressure feedback of the catheter tip in the vascular model in real time through the processing and display unit; S4: Adjust the catheter tip according to the navigation guidance and finally place it into the target navigation area, and fix the catheter after confirmation.

[0082] Storage unit 320 may include readable media in the form of volatile storage units, such as random access memory (RAM) 3201 and / or cache memory 3202, and may further include read-only memory (ROM) 3203.

[0083] Storage unit 320 may also include a program / utility 3204 having a set (at least one) program module 3205, such program module 3205 including but not limited to: operating system, one or more application programs, other program modules and program data, each or some combination of these examples may include an implementation of a network environment.

[0084] Bus 330 can represent one or more of several types of bus structures, including a memory cell bus or memory cell controller, a peripheral bus, a graphics acceleration port, a processing unit, or a local bus using any of the various bus structures.

[0085] Electronic device 300 can also communicate with one or more external devices 200 (e.g., keyboard, pointing device, Bluetooth device, etc.), and with one or more devices that enable a user to interact with electronic device 300, and / or with any device that enables electronic device 300 to communicate with one or more other computing devices (e.g., router, modem, etc.). This communication can be performed via input / output (I / O) interface 350. Furthermore, electronic device 300 can also communicate with one or more networks (e.g., local area network (LAN), wide area network (WAN), and / or public networks, such as the Internet) via network adapter 360. As shown, network adapter 360 communicates with other modules of electronic device 300 via bus 330. It should be understood that, although not shown in the figures, other hardware and / or software modules can be used in conjunction with electronic device 300, including but not limited to: microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data backup storage systems.

[0086] From the above description of the embodiments, those skilled in the art will readily understand that the exemplary embodiments described herein can be implemented by software or by combining software with necessary hardware. Therefore, the technical solutions according to the embodiments of this disclosure can be embodied in the form of a software product, which can be stored in a non-volatile storage medium (such as a CD-ROM, USB flash drive, external hard drive, etc.) or on a network, including several instructions to cause a computing device (such as a personal computer, server, terminal device, or network device, etc.) to execute the methods according to the embodiments of this disclosure.

[0087] In exemplary embodiments of this disclosure, a computer-readable storage medium is also provided, on which a program product capable of implementing the methods described above is stored. In some possible embodiments, various aspects of the invention may also be implemented as a program product comprising program code that, when the program product is run on a terminal device, causes the terminal device to perform the steps of the various exemplary embodiments of the invention described in the "Exemplary Methods" section of this specification.

[0088] refer to Figure 4 As shown, a program product 400 for implementing the above-described method according to an embodiment of the present invention is described. This product may employ a portable compact disc read-only memory (CD-ROM) and include program code, and may run on a terminal device, such as a personal computer. However, the program product of the present invention is not limited thereto. In this document, the readable storage medium may be any tangible medium containing or storing a program that may be used by or in conjunction with an instruction execution system, apparatus, or device.

[0089] The program product may employ any combination of one or more readable media. A readable medium may be a readable signal medium or a readable storage medium. A readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples (a non-exhaustive list) of readable storage media include: electrical connections having one or more wires, portable disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof.

[0090] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, carrying readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. A readable signal medium may also be any readable medium other than a readable storage medium, capable of sending, propagating, or transmitting programs for use by or in conjunction with an instruction execution system, apparatus, or device.

[0091] The program code contained on the readable medium may be transmitted using any suitable medium, including but not limited to wireless, wired, optical fiber, RF, etc., or any suitable combination thereof.

[0092] Program code for performing the operations of this invention can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java and C++, and conventional procedural programming languages ​​such as C or similar languages. The program code can execute entirely on the user's computing device, partially on the user's device, as a standalone software package, partially on the user's computing device and partially on a remote computing device, or entirely on a remote computing device or server. In cases involving remote computing devices, the remote computing device can be connected to the user's computing device via any type of network, including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computing device (e.g., via the Internet using an Internet service provider).

[0093] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0094] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A midline catheter with intelligent navigation function, comprising a catheter body, characterized in that, The distal end of the catheter body is integrated with a miniature sensor module for real-time sensing of position and / or mechanical state information.

2. The centerline conduit with intelligent navigation function according to claim 1, characterized in that, The micro-sensor module includes at least one of an electromagnetic sensor and a micro-pressure sensor; the electromagnetic sensor is used to generate a position signal under the induction of an external magnetic field; the micro-pressure sensor is attached to the outer wall of the catheter body and is used to sense the contact pressure between the catheter tip and the blood vessel wall.

3. The centerline conduit with intelligent navigation function according to claim 2, characterized in that, The catheter body contains embedded microwires electrically connected to the microsensor module, and the microwires extend along the catheter wall to the connector interface at the proximal end.

4. A centerline conduit system with intelligent navigation function, characterized in that, include: The centerline conduit with intelligent navigation function as described in any one of claims 1-3; An external positioning and navigation device is used to interact with the micro-sensor module to obtain position signals and / or pressure signals at the catheter tip; The processing and display unit is communicatively connected to the external positioning and navigation device, and is used to receive the signal, register it with a pre-stored patient vascular model, and generate a navigation interface that includes the real-time position and orientation of the catheter tip.

5. The centerline conduit system with intelligent navigation function according to claim 4, characterized in that, The external positioning and navigation device is an electromagnetic positioning generator that generates a weak magnetic field with a known spatial distribution; the micro-sensor module is an electromagnetic sensor coil.

6. The centerline conduit system with intelligent navigation function according to claim 4, characterized in that, The processing and display unit includes: The image registration module 230 is used to spatially register the real-time acquired catheter tip coordinates with the patient's preoperative or intraoperative medical imaging data. The navigation algorithm module has a built-in vascular centerline path planning algorithm, which is used to calculate and display the expected catheter travel path; The warning module is used to issue a visual or audible warning signal when the pressure value returned by the miniature pressure sensor exceeds a set threshold, or when the position of the catheter tip deviates from the predetermined path.

7. The centerline conduit system with intelligent navigation function according to claim 6, characterized in that, The navigation interface simultaneously displays: a three-dimensional vascular model based on medical image reconstruction, real-time position and orientation icons of the catheter tip, a preset ideal catheter placement target area, and real-time pressure oscilloscope waveforms or values.

8. The centerline conduit system with intelligent navigation function according to claim 4, characterized in that, The system also includes a portable handheld terminal that is wirelessly connected to the processing and display unit to display simplified navigation information for convenient viewing by the operator outside the bedside sterile area.

9. A method for intelligent navigation placement of a midline catheter using the system described in any one of claims 4-8, characterized in that, Includes the following steps: S1: Acquire medical images of the patient's chest vessels, construct a personalized three-dimensional vascular model of the superior vena cava, and mark the target navigation area; S2: Establish the spatial coordinate mapping relationship between the external positioning and navigation device and the patient's body surface; S3: Insert the catheter under aseptic conditions and observe the catheter tip's position and pressure feedback in the vascular model in real time through the processing and display unit; S4: Following the navigation guidance, adjust the catheter tip and finally place it into the target navigation area. After confirmation, fix the catheter in place.

10. The method according to claim 9, characterized in that, In step S3, the operator avoids forceful pushing based on pressure feedback and identifies and corrects cases where the catheter is mistakenly inserted into a branch blood vessel based on location information.

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