Intraoperative heart conduction bundle detection marker pen and detection method

Abstract

The invention belongs to the technical field of marking devices, and provides an intraoperative heart conduction bundle detection marking pen and a detection method.The intraoperative heart conduction bundle detection marking pen comprises a pen holder body, a control circuit is arranged in the pen holder body, and a wiring end is arranged at the tail end of the pen holder body; the detection assembly comprises a first potential detection point, a second potential detection point and a current release point, and the first potential detection point, the second potential detection point and the current release point are all arranged at the front end of the pen holder main body; the marking assembly comprises a sterile marking head and a pressing triggering mechanism, and the pressing triggering mechanism controls the sterile marking head to stretch out and draw back; a current display screen and a current adjusting button are integrated on the outer surface of the pen holder body, and the detection assembly, the current display screen and the current adjusting button are all electrically connected with the control circuit. According to the method, the electrophysiological difference between the conduction beam and the myocardial cells in the hyperpolarization state is detected in real time through the double-potential detection points, the recognition accuracy is high, the problem of misjudgment of complex malformation cases is effectively solved, and mechanical damage caused by traditional suture or electrocautery marking is avoided.

Description

Technical Field

[0001] The invention belongs to the technical field of marking devices, in particular to a marking pen and a detection method for intraoperative cardiac conduction bundle detection. Background Art

[0002] In cardiac surgery, especially when repairing structural heart abnormalities such as congenital heart disease and valvular disease, precise manipulation of the surgical incision or suture area is crucial. Because the anatomical location of cardiac conduction bundles (such as the atrioventricular bundle, the His bundle, and its branches) within the heart varies from person to person, and in some cases, the conduction bundles have abnormal course, accidental damage to the conduction bundles can lead to severe postoperative arrhythmias (such as atrioventricular block) and even the need for permanent pacemaker implantation.

[0003] Traditional intraoperative conduction bundle localization methods rely primarily on surgeon experience, preoperative imaging prediction, or intraoperative electrophysiological mapping. However, during cardioplegic perfusion and cryopreservation, myocardial cells and conduction bundle cells are hyperpolarized and unable to actively generate action potentials. Conventional electrophysiological equipment has difficulty distinguishing conduction bundles from normal myocardial tissue based on action potential differences.

[0004] Therefore, the existing intraoperative conduction bundle positioning method requires combining anatomical landmarks and manual feel to determine the position of the conduction bundle, which can easily lead to misjudgment in complex deformity cases. The error of traditional suture marking or electrocautery marking can reach 2-3mm, which may cause mechanical damage, and requires repeated adjustment of stimulation parameters or switching of equipment, which prolongs the operation time and increases the risk of complications.

[0005] Therefore, those skilled in the art have proposed an intraoperative cardiac conduction bundle detection marker pen and a detection method to solve the problems raised in the background art. Summary of the Invention

[0006] In order to solve the above technical problems, the present invention provides an intraoperative cardiac conduction bundle detection marking pen and a detection method to solve the problems in the existing intraoperative conduction bundle positioning method that require combining anatomical landmarks and hand feel to determine the position of the conduction bundle, which is prone to misjudgment of complex deformity cases.

[0007] An intraoperative cardiac conduction bundle detection marking pen comprises: a pen body, a control circuit is built into the pen body, and a terminal is provided at the end of the pen body;

[0008] A detection assembly, comprising a first potential detection point, a second potential detection point, and a current release point, wherein the first potential detection point, the second potential detection point, and the current release point are all located at the front end of the pen body;

[0009] A marking assembly comprising a sterile marking head and a press trigger mechanism, wherein the press trigger mechanism controls the extension and retraction of the sterile marking head;

[0010] The outer surface of the pen body is integrated with a current display screen and a current adjustment button, and the detection component, current display screen and current adjustment button are all electrically connected to the control circuit.

[0011] Preferably, the first potential detection point and the second potential detection point are spaced apart by 1-2.0 mm.

[0012] Preferably, the control circuit includes a signal acquisition and amplification module, a potential difference analysis module, a feedback trigger and marking control module, a current stimulation generation module, and a power management module; the signal acquisition and amplification module includes an operational amplifier (Op-Amp) and a low-pass filter (RC circuit);

[0013] The potential difference analysis module includes a differential amplifier, an analog-to-digital converter and a microcontroller;

[0014] The feedback trigger module adopts a digital comparator;

[0015] The current stimulation generation module includes a constant current source circuit, a digital potentiometer and a multiplexer;

[0016] The power management module includes a lithium battery pack, a low dropout regulator (LDO) and an isolated DC-DC module.

[0017] Preferably, the press trigger mechanism includes a marking button, a telescopic rod, a connecting sleeve, a limiting ring and a return spring. The telescopic rod is slidably installed in the pen body, and a sterile marking head is provided at the end of the telescopic rod. The limiting ring and the connecting sleeve are installed around the telescopic rod. The return spring is limitedly installed in the pen body, the limiting ring abuts against the top of the return spring, and the connecting sleeve is fixedly connected with a guide part on the side. The marking button is slidably installed on the outer wall of the pen body, and a pressure rod is fixedly installed on the inner wall of the marking button. The position of the pressure rod corresponds to the guide part, and the sterile marking head.

[0018] Preferably, the pen body is made of polyetheretherketone.

[0019] Preferably, the sterile marking head dye is a PLGA-based methylene blue complex, and the marking accuracy is ±0.3 mm.

[0020] A method for detecting cardiac conduction bundles during surgery comprises the following steps:

[0021] S1. Place the probe assembly in contact with the endocardial surface and apply a suprathreshold current stimulus through the current release point.

[0022] S2, collecting potential signals of myocardial cells and conduction bundle cells in real time through the first potential detection point and the second potential detection point;

[0023] S3, analyzing the potential difference between the two detection points. If the sum of the difference is greater than a set threshold and the duration exceeds the set threshold, it is determined to be the conduction beam position;

[0024] S4. Mark the conduction bundle path area using the marking component.

[0025] Preferably, the above-threshold current intensity is adjusted by a current adjustment button.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] The present invention uses dual potential detection points to detect the electrophysiological differences between conduction bundles and myocardial cells in a hyperpolarized state in real time, with high recognition accuracy, effectively solving the problem of misjudgment in complex deformity cases; it uses absorbable PLGA dyes and a press-trigger mechanism to avoid the mechanical damage of traditional sutures or electrocautery markings, and the dye is completely degraded 48 hours after surgery, ensuring no risk of tissue residue; it integrates current regulation and real-time data display functions, and the surgeon can dynamically adjust parameters with a single-handed operation, significantly shortening the operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0029] Figure 2 It is a schematic diagram of the cross-sectional structure of the present invention;

[0030] Figure 3 This is a schematic diagram of the control module.

[0031] In the picture:

[0032] 1. Pen body; 2. Detection assembly; 201. First detection point; 202. Second detection point; 203. Current release point; 3. Sterile marking head; 4. Telescopic rod; 5. Current display screen; 6. Current adjustment knob; 7. Indicator light; 8. Wiring terminal; 9. Connecting sleeve; 10. Guide part; 11. Marking button; 12. Pressure rod; 13. Limiting ring; 14. Return spring. DETAILED DESCRIPTION

[0033] The following embodiments of the present invention are described in further detail with reference to the accompanying drawings and examples. The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0034] As attached Figure 1 To the attached Figure 3 As shown: The present invention provides an intraoperative cardiac conduction bundle detection marking pen, comprising a pen body 1, a detection component 2 and a marking component;

[0035] The pen body 1 has a built-in control circuit, and a terminal 8 is provided at the end of the pen body 1;

[0036] The detection assembly 2 includes a first potential detection point 201, a second potential detection point 202, and a current release point 203. The first potential detection point 201, the second potential detection point 202, and the current release point 203 are all located at the front end of the pen body 1. The detection assembly 2 is used to apply electrical stimulation above the hyperpolarization threshold to the myocardial tissue and to collect the potential signal after the stimulation.

[0037] The marking assembly includes a sterile marking head 3 and a press-trigger mechanism. The press-trigger mechanism controls the extension and retraction of the sterile marking head 3 to leave a mark on the endocardial surface. The pen body 1 is made of polyetheretherketone. The dye in the sterile marking head 3 is a PLGA-based methylene blue complex with a marking accuracy of ±0.3mm. It completely degrades within 48 hours after surgery and complies with FDA 21 CFR 73.3120.

[0038] The outer surface of the pen body 1 is integrated with a current display screen 5 and a current adjustment button 6. The detection component 2, the current display screen 5 and the current adjustment button 6 are all electrically connected to the control circuit; the current adjustment button 6 is used to dynamically adjust the stimulation current intensity according to the intraoperative conditions; the current display screen 5 is used to display the stimulation current intensity, potential difference value and marking status in real time.

[0039] The interval between the first potential detection point 201 and the second potential detection point 202 is 1-2.0 mm.

[0040] The control circuit includes a signal acquisition and amplification module, a potential difference analysis module, a feedback trigger and marking control module, a current stimulation generation module, and a power management module;

[0041] The signal acquisition and amplification module includes a high-precision operational amplifier Op-Amp and a low-pass filter RC circuit; the operational amplifier is used to amplify the weak bioelectrical signals (μV level) collected by the dual potential detection points (201, 202) to improve the signal-to-noise ratio, and the low-pass filter (RC circuit) filters out high-frequency interference (electric knife noise) and retains the 0-100Hz myocardial action potential signal;

[0042] The potential difference analysis module includes a differential amplifier, an analog-to-digital converter, and a microcontroller. The differential amplifier amplifies the difference between the two potential signals and converts it into an analyzable voltage signal. The analog-to-digital converter (ADC), using the ADS1115, converts the analog potential difference signal into a digital signal for processing by the microcontroller. The microcontroller (MCU), using the STM32 series, executes an algorithm to determine whether the potential difference exceeds a set threshold (>100μV, lasting >20ms) and triggers a marking action.

[0043] The feedback trigger module uses a digital comparator, which helps the MCU quickly determine whether the potential difference meets the standard and reduce processing delays;

[0044] The current stimulation generation module includes a constant current source circuit, a digital potentiometer, and a multiplexer. The constant current source circuit uses the LM334 chip to generate an adjustable stimulation current of 0.1-5mA, ensuring the current is stable and meets the safety threshold. The digital potentiometer (DigiPot) uses the AD5242, and its resistance is adjusted by the MCU to dynamically control the current intensity (to adapt to different cardioplegic solutions or temperature conditions). The multiplexer (MUX) switches between different current levels (such as pulse frequency 1-10Hz and pulse width 0.5-2ms).

[0045] The power management module includes a lithium battery pack, a low-dropout voltage regulator (LDO), and an isolated DC-DC module. The lithium battery pack (3.7V, medical grade) provides portable power to support continuous use during surgery. The low-dropout voltage regulator (LDO) uses the TPS7A47 to provide stable voltage (±5V, 3.3V) for each module to avoid noise interference. The isolated DC-DC module achieves electrical isolation between the signal circuit and the power circuit to prevent leakage risks.

[0046] The pressing trigger mechanism includes a marking button 11, a telescopic rod 4, a connecting sleeve 9, a limiting ring 13 and a reset spring 14. The telescopic rod 4 is slidably installed in the pen body 1, and a sterile marking head 3 is provided at the end of the telescopic rod 4. A limiting ring 13 and a connecting sleeve 9 are installed around the telescopic rod 4. The reset spring 14 is limitedly installed in the pen body 1, and the limiting ring 13 abuts against the top of the reset spring 14. The connecting sleeve 9 is fixedly connected to a guide part 10. The marking button 11 is slidably installed on the outer wall of the pen body 1, and a pressure rod 1 is fixedly installed on the inner wall of the marking button 11. 2. The position of the pressure rod 12 corresponds to the guide part 10, and the sterile marking head 3 is formed; by pressing the marking button 11, the pressure rod 12 is driven to move downward, and the guide part 10 is squeezed during the downward movement of the pressure rod 12, so that the telescopic rod 4 is retracted from the end of the pen body 1, and the sterile marking head 3 is extended from the end of the pen body to achieve sterile marking; the reset spring 14 is combined with the limiting ring 13 to ensure that the reset spring 14 is stably compressed when the telescopic rod 4 moves. After releasing the marking button 11, the reset spring 14 contracts, and the sterile marking head 3 is received into the pen body 1.

[0047] The pen body 1 is made of polyetheretherketone; the dye of the sterile marking head 3 is a PLGA-based methylene blue complex, and the marking accuracy is ±0.3mm. It is completely degraded within 48 hours after surgery and complies with FDA21CFR73.3120 standards.

[0048] During cardiac surgery, the surgeon first connects the device to an external power source or control system via the terminal 8 at the end of the pen body 1. During detection, the first potential detection point 201, the second potential detection point 202, and the current release point 203 at the front end of the pen body are lightly touched to the myocardial surface. Under the action of the control circuit, the current release point 203 applies an adjustable electrical stimulation of 0.1-5mA to the myocardial tissue (the current intensity can be dynamically adjusted by the current adjustment button 6). At this time, the first and second potential detection points synchronously collect bioelectric signals from the myocardial surface. The weak original signal (μV level) is processed by the signal acquisition and amplification module: first amplified by a high-precision operational amplifier, and then filtered out high-frequency interference through a low-pass filter, retaining the effective action potential signal of 0-100Hz.

[0049] The amplified two-way potential signal enters the potential difference analysis module, the differential amplifier calculates the difference between the two and further amplifies it, the ADS1115 analog-to-digital converter converts the analog difference into a digital signal, and the STM32 microcontroller performs algorithm analysis to determine whether the potential difference exceeds 100μV and lasts for more than 20ms (at the same time, the digital comparator assists in quick judgment to reduce delays). If it meets the standard, the microcontroller triggers the feedback trigger and marking control module. At this time, the operator presses the marking button 11, driving the pressure rod 12 to squeeze the guide part 10, so that the telescopic rod 4 pushes the sterile marking head 3 out of the pen body, leaving a precise mark on the endocardial surface (accuracy ±0.3mm). After the marking is completed, release the button, the reset spring 14 drives the telescopic rod to retract through the limit ring 13, and the marking head is retracted into the pen.

[0050] Throughout the entire process, the current display 5 shows the stimulation current intensity, potential difference, and marking status in real time. The device is powered by a medical-grade lithium battery pack, which is processed by a low-dropout voltage regulator and an isolated DC-DC module to ensure stable power supply to each module and avoid leakage risks. The PLGA-based methylene blue complex dye used for marking complies with FDA standards and is fully degraded within 48 hours after surgery, eliminating the need for secondary removal.

[0051] The detection method includes the following steps:

[0052] S1. Place the detection component 2 in contact with the endocardial surface and apply a suprathreshold current stimulus through the current release point 203;

[0053] S2, collecting potential signals of myocardial cells and conduction bundle cells in real time through the first potential detection point 201 and the second potential detection point 22;

[0054] S3. Analyze the potential difference between the two detection points. If the sum of the difference is greater than a set threshold of 100 μV and the duration exceeds a set threshold of 20 ms, it is determined to be the location of the conduction bundle.

[0055] S4. Mark the conduction bundle path area using the marking component.

[0056] The suprathreshold current intensity is adjusted by the current adjustment button 6 according to the type of intraoperative cardioplegic solution, myocardial temperature and individual differences, with an adjustment step of 0.1 mA.

[0057] Here's how it works:

[0058] Electrical stimulation and signal acquisition: The current release point 203 applies a suprathreshold current (0.1-5 mA) to the myocardial tissue, stimulating the conduction bundles and myocardial cells in the hyperpolarized state to generate differential action potentials.

[0059] The first potential detection point 201 and the second potential detection point 202 collect potential signals in real time, and the action potential of the cells in the conduction bundle has a larger amplitude and a longer duration.

[0060] Signal processing and judgment:

[0061] Signal acquisition and amplification module: A high-precision operational amplifier is used to amplify μV-level bioelectric signals, and a low-pass filter is used to filter out high-frequency interference.

[0062] Potential difference analysis module: The differential amplifier calculates the potential difference between the two detection points, the analog-to-digital converter converts the analog signal into a digital signal, and the microcontroller (STM32F4) executes the algorithm. If the potential difference is greater than 100 μV and lasts for more than 20 ms, it is determined to be the location of the conduction bundle.

[0063] Feedback and Mark Trigger:

[0064] Feedback trigger module: The digital comparator assists the MCU in quickly determining the threshold and triggering the marking action.

[0065] The marking button 11 drives the pressure rod 12 to push the guide part 10, compressing the return spring 14 to extend the telescopic rod 4, and the sterile marking head 3 contacts the endocardium to release the PLGA dye. After the marking is completed, the return spring 14 rebounds and resets.

[0066] The operator adjusts the resistance of the digital potentiometer through the current adjustment button 6 to change the output current of the constant current source (step size 0.1mA) to adapt to different cardioplegic fluid or myocardial temperature conditions.

[0067] The current display screen 5 displays the current intensity (mA), potential difference (μV) and marking status in real time.

[0068] Example 1: Atrioventricular conduction bundle marking steps:

[0069] Preoperative preparation: Connect the probe pen to the control host, initialize the current intensity to 2.0mA (default parameter), and calibrate the sterile marking head 3.

[0070] Intraoperative operation: lightly touch the probe tip to the right atrial endocardium and start current stimulation through the pen;

[0071] Current display screen 5 shows the real-time potential difference value: initial value 50μV → gradually increases to 120μV (lasting 25ms);

[0072] The microcontroller triggers the feedback module and presses the marking button 11), the telescopic rod 4 extends, and the PLGA dye marks the conduction bundle running area with a marking diameter of 0.5 mm;

[0073] After the operation, electrophysiological mapping was performed to verify that the marked position was consistent with the conduction bundle (error 0.2mm).

[0074] Postoperative monitoring: The dye was completely degraded 48 hours after the operation, and there was no atrioventricular block on the electrocardiogram.

[0075] Example 2: Complex heart deformity repair steps:

[0076] Intraoperative challenges: The conduction bundles have abnormal course and are difficult to locate using traditional imaging.

[0077] Operational adjustments: adjust the current intensity to 3.5 mA (due to an increased threshold for myocardial edema); adjust the interval between the bipotential detection points to 2.0 mm to improve signal resolution;

[0078] The display shows the potential difference fluctuation in real time (80-150μV), and a marker is triggered when the difference is >100μV for 30ms;

[0079] A total of 3 abnormal conduction bundle branches were marked, taking a total of 20 seconds.

[0080] Effect verification:

[0081] Postoperative electrophysiological mapping showed that the marked points were consistent with the anatomical position of the conduction bundle, there was no intraoperative damage, and the patient did not experience arrhythmia.

[0082] Example 3: Intraoperative localization and marking of conduction bundles in infants with complex congenital heart disease

[0083] Surgical background: The patient, aged 6 months, was diagnosed with complete atrioventricular septal defect (CAVSD) and abnormal conduction bundle. Conventional imaging could not accurately locate the His bundle branches. Intraoperative damage to the conduction bundle was necessary to prevent complete atrioventricular block after surgery.

[0084] Equipment calibration: Connect the probe to the portable control host (model CB-2000) and initialize the parameter settings:

[0085] Initial current intensity: 1.2mA (adapted to the thinner myocardium thickness of infants and young children);

[0086] Potential difference threshold: 80μV (20% lower than adult threshold);

[0087] Dual detection point spacing: 1.5mm (balance between signal resolution and space limitations).

[0088] The sterile marking tip (3) is loaded with PLGA-methylene blue dye (concentration 0.3% w / v), and the marking diameter is preset to 0.5 mm.

[0089] Safety verification: Use simulated myocardial tissue (silicone model, resistivity simulates real myocardium) to test the output current stability of the probe pen (error ≤ 0.05mA) and verify the leakage current (≤ 8μA).

[0090] Step 1: The operator gently touches the probe tip to the endocardium at the edge of the atrial septal defect and starts current stimulation (pulse frequency 5 Hz, pulse width 1 ms).

[0091] Step 2: The current display screen 5 displays the potential difference fluctuation in real time (initial value 40 μV → gradually increases to 95 μV, lasting 22 ms).

[0092] Step 3: The microcontroller determines that the potential difference exceeds the threshold, triggers the feedback module, presses the marking button 11 downward, drives the telescopic rod 4 to extend, and the PLGA dye accurately marks the His bundle branch site.

[0093] During the operation, the threshold of myocardial cells increased due to low temperature (25°C). The surgeon increased the current intensity to 1.8 mA (0.1 mA step) through the current adjustment button 6, and the potential difference value recovered to 105 μV (lasting 25 ms), completing the second marking.

[0094] Multi-area marking: A total of 3 key conduction bundle areas were marked, taking a total of 9 seconds, without bleeding or tissue tearing during the procedure.

[0095] Electrophysiological mapping verification: An intraoperative electrophysiological mapping instrument (EP-3000) was used to compare the marked points with the actual course of the conduction bundle, with a maximum error of 0.25 mm and a 100% coincidence rate.

[0096] Postoperative monitoring: electrocardiogram 24 hours after surgery showed sinus rhythm, no atrioventricular block or arrhythmia;

[0097] An echocardiogram performed 48 hours after surgery showed that the dye marking points were completely absorbed, with no residual or inflammatory reaction in the endocardium; a follow-up examination 3 months after surgery showed that the child's cardiac function was normal and there were no conduction system complications.

[0098] Example 4: Material safety and performance verification

[0099] Steps: Insulation material testing:

[0100] The pen holder was immersed in simulated body fluid (37°C, pH 7.4) for 72 hours, and the amount of ion precipitation was tested, which was in line with the YY / T1556-2017 standard.

[0101] Dye degradation experiment: PLGA dye-marked points were implanted subcutaneously in rats. Micro-CT showed that the dye volume was reduced to 5% on the third day after surgery and was completely absorbed on the seventh day without any inflammatory reaction.

[0102] Circuit safety verification: Tests the leakage current (≤8μA) of isolated DC-DC modules, complying with the IEC 60601-1 medical electrical safety standard.

[0103] The key parameters and verification data are as follows:

[0104]

[0105] This device uses dual potential detection points (1-2.0mm apart) combined with a high-precision signal processing module (μV-level amplification, low-pass filtering and differential analysis) to detect the electrophysiological differences between conduction bundles and myocardial cells in a hyperpolarized state in real time, significantly reducing the risk of misdiagnosis in complex malformation cases; it uses absorbable PLGA dye (marking accuracy ±0.3mm) and a mechanical press trigger mechanism (telescopic rod and reset spring linkage) to avoid tissue penetrating damage, and the dye is completely degraded within 48 hours after surgery, with no residual risk; it integrates adaptive current regulation (0.1-5mA, step size 0.1mA) and real-time data display (current intensity, potential difference, marking status), so the surgeon can complete dynamic adjustment of stimulation parameters with one hand, and single-point marking takes ≤3 seconds, effectively shortening the operation time; medical-grade insulation materials and isolated power supply design ensure electrical safety; modular circuits support adaptability to different cardioplegia solutions, myocardial temperatures and individual anatomical differences, making it suitable for promotion in grassroots hospitals.

[0106] The embodiments of the present invention are provided for the purpose of illustration and description. Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limitations on the present invention. Ordinary technicians in this field can change, modify, replace and deform the above embodiments within the scope of the present invention.

[0107] In the description of this specification, the reference terms "one embodiment", "some embodiments", "examples", "specific examples" or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0108] In the drawings of the embodiments disclosed in the present invention, only the structures involved in the embodiments disclosed in the present invention are involved. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of the present invention can be combined with each other.

[0109] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A marking pen for detecting cardiac conduction bundle during surgery, characterized in that: include: A pen body (1), wherein the pen body (1) has a built-in control circuit, and a terminal (8) is provided at the end of the pen body (1); A detection assembly (2), comprising a first potential detection point (201), a second potential detection point (202), and a current release point (203), wherein the first potential detection point (201), the second potential detection point (202), and the current release point (203) are all arranged at the front end of the pen body (1); A marking assembly comprising a sterile marking head (3) and a press trigger mechanism, wherein the press trigger mechanism controls the extension and retraction of the sterile marking head (3); The outer surface of the pen body (1) is integrated with a current display screen (5) and a current adjustment button (6); the detection component (2), the current display screen (5) and the current adjustment button (6) are all electrically connected to the control circuit.

2. The intraoperative cardiac conduction bundle detection marker pen according to claim 1, characterized in that: The first potential detection point (201) and the second potential detection point (202) are spaced apart by 1-2.0 mm.

3. The intraoperative cardiac conduction bundle detection marker pen according to claim 1, characterized in that: The control circuit includes a signal acquisition and amplification module, a potential difference analysis module, a feedback trigger and marking control module, a current stimulation generation module, and a power management module; The signal acquisition and amplification module includes an operational amplifier and a low-pass filter; The potential difference analysis module includes a differential amplifier, an analog-to-digital converter and a microcontroller; The feedback trigger module adopts a digital comparator; The current stimulation generation module includes a constant current source circuit, a digital potentiometer and a multiplexer; The power management module includes a lithium battery pack, a low voltage dropout regulator and an isolated DC-DC module.

4. The intraoperative cardiac conduction bundle detection marker pen according to claim 1, characterized in that: The press trigger mechanism includes a marking button (11), a telescopic rod (4), a connecting sleeve (9), a limiting ring (13) and a return spring (14); the telescopic rod (4) is slidably installed in the pen body (1); a sterile marking head (3) is provided at the end of the telescopic rod (4); a limiting ring (13) and a connecting sleeve (9) are installed around the telescopic rod (4); a return spring (14) is limitedly installed in the pen body (1); the limiting ring (13) abuts against the top of the return spring (14); a guide portion (10) is fixedly connected to the circumference of the connecting sleeve (9); the marking button (11) is slidably installed on the outer wall of the pen body (1); a pressure rod (12) is fixedly installed on the inner wall of the marking button (11); the position of the pressure rod (12) corresponds to the guide portion (10), and the sterile marking head (3).

5. The intraoperative cardiac conduction bundle detection marker pen according to claim 1, characterized in that: The pen body (1) is made of polyetheretherketone.

6. The intraoperative cardiac conduction bundle detection marker pen according to claim 1, characterized in that: The dye of the sterile marking head (3) is a PLGA-based methylene blue complex, and the marking accuracy is ±0.3mm.

7. A method for detecting cardiac conduction bundles during surgery, characterized in that: The following steps are involved: S1, contacting the detection component (2) with the endocardial surface and applying a suprathreshold current stimulus through the current release point (203); S2, collecting potential signals of myocardial cells and conduction bundle cells in real time through the first potential detection point (201) and the second potential detection point (22); S3, analyzing the potential difference between the two detection points. If the sum of the difference is greater than a set threshold and the duration exceeds the set threshold, it is determined to be the conduction beam position; S4. Mark the conduction bundle path area using the marking component.

8. The method for detecting cardiac conduction bundles during surgery according to claim 7, wherein: The above-threshold current intensity is adjusted by a current adjustment button (6).

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