Biopsy puncture auxiliary method and system capable of controlling breathing amplitude

Abstract

The invention relates to the technical field of medical treatment, in particular to a biopsy puncture assisting method and system capable of controlling the breathing amplitude. The method comprises the following steps that an adjustable inflatable bellyband is fixed to the thoracico-abdominal area of a patient, and the expansion amplitude of the thorax and the abdomen of the patient is limited through bellyband pressure, so that the amplitude range of respiratory movement of the patient is adjusted and controlled; a sensing device is arranged to collect displacement change data of an abdominal belt in the respiratory movement of a patient in real time and display the displacement change data in real time so as to generate respiratory displacement data; establishing time synchronization association between a control host connected with the sensing device and the image detection equipment, binding the control host and the image detection equipment, and determining a respiratory displacement reference point when the focus is stable; an allowable fluctuation interval is set based on the respiratory displacement datum point, a puncture feasible signal is sent out through a prompt device, and an operator is assisted in completing biopsy puncture operation in a relatively stable stage. The breathing amplitude can be effectively controlled through pressurization of the inflatable bellyband, and therefore focus displacement caused by breathing is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical technology, in particular to a biopsy puncture auxiliary method and system capable of controlling the amplitude of respiration. BACKGROUND

[0002] As a core means of obtaining human tissue samples to determine the nature of lesions, if the lesion is displaced due to respiratory movement during the puncture process, it will not only lead to puncture failure and sample mis-taking, but also damage normal tissues such as blood vessels and nerves, thereby causing serious complications such as bleeding and infection.

[0003] In addition, the same patent such as CN116421158A discloses a kidney biopsy puncture monitoring auxiliary method and biopsy puncture sampling device, which comprises: detecting the vital signs of the patient to determine whether it is suitable for puncture; if it is suitable, mechanically close the patient's nose, and issue a start puncture instruction after detecting that the closing effect is good. The present application selects the appropriate puncture time through vital sign monitoring, and assists the puncture operation with the help of nose closure, reduces the risk of puncture bleeding and the difficulty of doctor's operation, and ensures the quality of kidney biopsy sampling. But the core of this scheme focuses on the evaluation of the body condition before puncture and the auxiliary closing operation during puncture, and does not involve active control of the amplitude of respiration, which cannot fundamentally solve the problem of lesion displacement caused by respiratory movement, especially for puncture of organs such as lungs which are significantly affected by respiration, and the adaptability is insufficient. SUMMARY

[0004] In order to solve the above technical problems existing in the current puncture auxiliary process, the present application provides a biopsy puncture auxiliary method capable of controlling the amplitude of respiration, which can effectively solve the problem of being unable to cope with the displacement of lesions caused by respiration, especially for puncture of organs such as lungs which are significantly affected by respiration, and realize active control of respiration and accurate matching of puncture time, make up for the deficiency of only evaluating the body condition without respiratory regulation, thereby greatly improving the puncture accuracy and safety, which is a biopsy puncture auxiliary method capable of controlling the amplitude of respiration, comprising the following steps:

[0005] An adjustable inflatable abdominal belt is fixed on the chest and abdominal area of the patient, different pressure levels are formed by periodically filling gas into the adjustable inflatable abdominal belt, and the expansion range of the patient's chest and abdomen is limited by the pressure of the abdominal belt, so as to regulate the amplitude range of the patient's respiratory movement;

[0006] A sensing device is arranged on the surface of the adjustable inflatable abdominal belt, the displacement change data of the abdominal belt in the patient's respiratory movement is collected in real time, the displacement change data is converted into dynamic waveform information reflecting the amplitude of respiration and is displayed in real time to generate respiratory displacement data;

[0007] The control host connected with the sensing device is time-synchronously associated with the image detection equipment, and the lesion position information captured by the image detection equipment and the respiratory displacement data at the corresponding time are bound through time axis matching to determine the respiratory displacement reference point when the lesion is stable;

[0008] The fluctuation interval allowed is set based on the respiratory displacement reference point, when the patient's respiratory displacement is within the fluctuation interval, the puncture feasible signal is sent through the prompting device to assist the operator to complete the biopsy puncture operation in the relatively stable stage of respiration.

[0009] The present application actively regulates the respiratory amplitude by means of the adjustable inflatable abdominal belt, forms different pressure levels by stage filling of gas, limits the expansion of chest and abdomen from the physical level, avoids the large displacement of lesions caused by respiratory movement, compared with only through the nose closed auxiliary operation, this design reduces the interference of respiration on puncture from the source, completely solves the pain point of "lesion moving with respiration leading to puncture deviation", and is more suitable for respiratory sensitive organs such as lung. Through the real-time collection and display of respiratory displacement dynamic waveform by the sensing device, the operator can intuitively master the patient's respiratory state, avoiding the blindness of similar schemes lacking respiratory process monitoring. Then, the lesion position information and the respiratory displacement data are bound according to the time axis to accurately locate the respiratory reference point when the lesion is stable, providing a scientific basis for subsequent puncture opportunity judgment, solving the limitation that similar schemes cannot associate lesions and respiratory state. Finally, based on the reference point, the fluctuation interval is set and the puncture feasible signal is sent to assist the operator to accurately operate in the stable stage of respiration, greatly reducing the puncture failure caused by respiratory fluctuation (such as mis-stimulating surrounding tissues), while reducing the difficulty of doctor's operation, taking into account the puncture safety and sample quality, making up for the shortcomings of similar schemes that only focus on preoperative evaluation and lack of respiratory dynamic regulation.

[0010] As preferred, the adjustable inflatable abdominal belt is fixed to the chest and abdominal region of the patient, and different pressure levels are formed by stage filling of gas into the adjustable inflatable abdominal belt, including:

[0011] The corresponding patient body characteristics are obtained, and the length of the adjustable inflatable abdominal belt is adjusted according to the patient body characteristics, so that it fits around the chest and abdominal region between the navel and xiphoid process of the patient, ensuring that the edges of the abdominal belt are wrinkle-free and do not compress important organs;

[0012] The inflatable pipeline of the adjustable inflatable abdominal belt is connected with the air pressure regulating device, and the initial amount of gas is filled into the adjustable inflatable abdominal belt through the air pressure regulating device, so that the adjustable inflatable abdominal belt generates a basic restraint force and records the initial pressure value;

[0013] The amount of inflation is gradually increased, and after each increase in the amount of inflation, the inflation is paused, the respiratory comfort and respiratory amplitude change of the patient are observed, and the current pressure value of the abdominal belt is monitored through the air pressure sensor;

[0014] determining a target pressure level according to the current pressure value of the abdominal belt, at which the respiratory comfort and respiratory amplitude change of the patient are within a preset controllable range and no obvious discomfort, keeping the current pressure value of the abdominal belt until the puncture operation is completed.

[0015] The present application solves the problems of "restraint discomfort and improper pressure" of the traditional abdominal belt fixation method through personalized pressure adjustment and safe and suitable design, and realizes the balance between precise controllable respiratory amplitude and patient comfort. The traditional abdominal belt often uses fixed size and pressure, which is easy to cause loose restraint (unable to limit breathing) or tight restraint (causing discomfort or even compression of internal organs) due to differences in patient body types, especially when puncturing sensitive organs such as the lungs, improper pressure will exacerbate respiratory disturbance or patient pain. This step first adjusts the length of the abdominal belt according to the patient's body type to ensure that it fits the area between the navel and the xiphoid process (avoiding important internal organs), reducing the risk of compression from a physical fixation perspective; then the air pressure adjusting device is inflated in stages, and the respiratory comfort and amplitude change are observed after each inflation, and the target pressure level is dynamically determined in combination with the air pressure sensor data - both ensuring that the respiratory amplitude is within a preset controllable range (such as reducing respiratory displacement by more than 50%) and ensuring that the patient has no obvious discomfort. This "personalized adaptation + stepwise pressure regulation" mechanism avoids the drawbacks of "one-size-fits-all" pressure settings, effectively limiting respiratory amplitude (reducing lesion displacement from the source) while maximizing patient safety and comfort, solving the pain point of the traditional solution that "restraint effect and comfort are difficult to balance", and laying a stable respiratory foundation for subsequent precise puncture.

[0016] As a preferred, the surface of the adjustable inflatable abdominal belt is provided with a sensing device, which collects displacement change data of the abdominal belt in the patient's respiratory movement in real time, and converts the displacement change data into dynamic waveform information reflecting the respiratory amplitude, including:

[0017] The sensing device is fixed at the center position of the upper surface of the adjustable inflatable abdominal belt, ensuring that the sensing device is closely attached to the upper surface of the adjustable inflatable abdominal belt and does not affect the patient's respiratory movement;

[0018] The sensing device captures the up-down displacement change of the adjustable inflatable abdominal belt with the patient's respiratory movement through the internal sensing element, converts the up-down displacement change into an electrical signal and transmits it to the control host;

[0019] The control host filters the received electrical signal to remove spurious signals generated by environmental interference and retains valid signals reflecting the patient's real respiratory movement;

[0020] The valid signal is converted into a corresponding displacement value, and the displacement value is plotted into a dynamic waveform graph in chronological order, with the horizontal axis representing time and the vertical axis representing respiratory displacement amplitude.

[0021] The present application solves the problems of "data distortion and non-intuitive feedback" of traditional respiratory monitoring by precise displacement sensing and signal processing, and provides a real and reliable respiratory dynamic basis for puncture timing judgment. The traditional method often relies on external equipment to indirectly infer the respiratory state (such as chest strap sensor which is easy to slide and leads to inaccurate data), and the data presentation form is single (only numerical display), which cannot intuitively reflect the respiratory amplitude trend. In this step, the sensing device is fixed on the center of the abdominal belt and closely attached to ensure the capture of the true displacement of the abdominal belt with breathing (avoiding sliding interference); the displacement is converted into an electrical signal by internal elements, and the effective respiratory signal is retained after filtering processing to remove environmental clutter (such as interference caused by slight body movement of the patient); finally, it is converted into a dynamic waveform graph (time on the horizontal axis and displacement amplitude on the vertical axis), allowing the operator to clearly observe the respiratory rhythm and amplitude fluctuation (such as a decrease in waveform peak indicating a controlled respiratory amplitude). This "precise collection + noise reduction processing + visual display" process not only ensures the authenticity of the respiratory displacement data (the error can be controlled within ±2mm), but also intuitively presents the respiratory state through the waveform graph, solving the problems of "inaccurate data and ambiguous feedback" of traditional monitoring, allowing the operator to real-time grasp the respiratory regulation effect, and providing high-quality dynamic reference for the binding of lesion and respiratory data.

[0022] As a preferred, the control host connected with the sensing device and the image detection equipment are time-synchronized and associated, and the lesion position information captured by the image detection equipment and the respiratory displacement data at the corresponding time are bound through time axis matching, including:

[0023] A data communication link is established between the control host connected with the sensing device and the image detection equipment, and a unified time reference signal is sent to both of them through a synchronization signal generator;

[0024] The control host and the image detection equipment respectively calibrate their own timing systems according to the time reference signal, ensuring that the time stamps of the two are consistent;

[0025] When the image detection equipment captures a clear CT lesion image during scanning, the time information at this time is recorded and marked as a lesion stable time point;

[0026] The control host receives the lesion stable time point, extracts the displacement value corresponding to this time point from the stored respiratory displacement data, associates and stores the lesion position information with the displacement value, and forms a binding relationship of time-displacement-lesion.

[0027] The time synchronization and data binding mechanism solves the problem of disconnection between the lesion position and the breathing state in the traditional puncture, and realizes the accurate association between the respiratory displacement and the stable position of the lesion. In the traditional scheme, the image device and the breathing monitoring device count separately, and the time difference leads to the inability to determine the corresponding breathing state when the lesion is stable (for example, the CT shows that the lesion is at a certain position, but it is unknown how much the respiratory displacement is at this time), and it is difficult to accurately determine the puncture time. In this step, the synchronous signal generator sends a unified time reference to the control host and the image device, ensuring that the timestamp error of the two is less than 10 ms; when the image device captures a clear CT lesion image (marked as a stable time point), the control host immediately extracts the respiratory displacement data at this time to form a "time-displacement-lesion" binding relationship (for example, when the lesion is stable at the X position, the respiratory displacement is Y value). This binding clarifies "which respiratory displacement corresponds to the stable lesion", solves the core pain point of "asynchronous between lesion position and breathing state", provides a precise reference for subsequent setting of the respiratory fluctuation range (for example, taking the bound displacement value as the center, allowing ± 3 mm fluctuation), and ensures that the operator can perform puncture in the relatively fixed breathing stage of the lesion, greatly improving the puncture accuracy, especially for organs such as the lungs that move significantly with breathing, effectively reducing the risk of puncture deviation caused by breathing.

[0028] Preferably, the respiratory displacement reference point when the lesion is stable comprises:

[0029] Extract the respiratory displacement value corresponding to the lesion stable time point from the binding relationship of time-displacement-lesion correspondence, and take the respiratory displacement value as the initial reference point;

[0030] Retrieve the respiratory displacement data in the preset time period before and after the initial reference point, and calculate the average value and fluctuation range of the respiratory displacement data in the time period;

[0031] If the deviation between the average value and the initial reference point is within the allowable range, the average value is determined as the respiratory displacement reference point when the lesion is stable;

[0032] If the deviation exceeds the allowable range, re-analyze the respiratory waveform before and after the lesion stable time point, and calculate the average value after excluding abnormal fluctuation data to determine the respiratory displacement reference point.

[0033] In the present application, the problem of "single and easy to be disturbed" in traditional reference point determination is solved by multi-dimensional data verification and exception exclusion, ensuring the accuracy and reliability of the stable lesion corresponding respiratory displacement reference point. Traditional methods often directly use the respiratory displacement value at a certain time as the reference point, without considering the possible accidental fluctuations of the data at that time (such as displacement abnormalities caused by sudden mild cough of the patient), which leads to the deviation of the reference point from the true stable state, and further affects the subsequent fluctuation interval setting. This step first extracts the initial reference point from the binding relationship, then retrieves the respiratory displacement data of the preset time period (such as 3-5 seconds) before and after it, and performs secondary verification by calculating the average value and fluctuation range - if the average value deviates from the initial reference point within the allowed range (such as ±1mm), it means that the respiratory state in this period is stable, and the average value can more objectively reflect the true reference; if the deviation exceeds the range (such as abnormal data caused by accidental body movement), the respiratory waveform is analyzed again, and the average value is calculated after excluding abnormal fluctuation data (such as sudden rise and fall of displacement value). This "initial extraction-time verification-exception exclusion" process avoids the accidental error of a single data point, so that the reference point can accurately correspond to the respiratory state of the stable lesion (the error can be controlled within ±0.5mm), solving the pain point of "inaccurate reference point leading to misjudgment of subsequent puncture opportunity", providing a scientific and reliable core basis for subsequent fluctuation interval setting, and ensuring the accuracy of subsequent puncture opportunity judgment.

[0034] As a preferred, the allowed fluctuation interval based on the respiratory displacement reference point setting includes:

[0035] The respiratory stability of the patient under the current inflatable abdominal belt pressure is analyzed, and the natural fluctuation range of the respiratory displacement data around the respiratory displacement reference point within the preset time length is counted;

[0036] Combining the requirement of puncture operation on respiratory stability, a safety factor is set based on the natural fluctuation range to determine the upper and lower limits of the fluctuation interval;

[0037] The respiratory displacement reference point and the upper and lower limit parameters of the fluctuation interval are input into the judgment module of the control host to form the judgment standard of the qualified range of respiratory displacement;

[0038] On the dynamic waveform graph, the respiratory displacement reference point is taken as the center, and the range of the fluctuation interval is marked with a mark, so that the operator can intuitively understand the fluctuation interval of the respiratory stability.

[0039] In the present application, through the design of "natural fluctuation analysis + safety factor superposition + visual presentation", the problems of "rigidity, not practical, not intuitive" in traditional fluctuation interval setting are solved, forming a reasonable interval that adapts to the individual respiratory characteristics of patients and meets the safety requirements of puncture. Traditional methods often use fixed fluctuation range (such as uniformly setting ±5mm), without considering the difference in respiratory stability of different patients under abdominal belt pressure (such as older patients may have larger respiratory fluctuations), which can easily lead to an interval that is too wide (unable to ensure lesion stability) or too narrow (frequently exceeding the interval, affecting puncture efficiency). This step first calculates the natural fluctuation range of the patient under the current abdominal belt pressure (such as a patient's natural fluctuation of ±2mm), then combines the requirements of puncture operation for precision (such as lung puncture requires higher precision, superimposes a safety factor of 1.2 times), to determine the personalized upper and lower limits (such as ±2.4mm); At the same time, input the interval parameters into the judgment module to form the judgment standard, and mark the interval range on the dynamic waveform graph with the reference point as the center (such as covering the qualified interval with green shadow). This design not only fits the real respiratory state of the patient (avoiding the rigidity of fixed interval), but also ensures the safety of puncture through the safety factor, and the visual marking makes the operator intuitive to know "whether the current breathing is in the qualified range" (such as the waveform is within the shadow, it is stable), solving the problem of "unscientific interval setting and difficult judgment for operators", ensuring that the fluctuation interval can effectively screen the stable breathing stage, and not causing too long puncture waiting time due to excessive strictness, balancing puncture precision and operation efficiency.

[0040] As a preferred, the puncture feasible signal sent by the prompting device when the patient's respiratory displacement is within the fluctuation interval includes:

[0041] The control host compares the current respiratory displacement data with the preset fluctuation interval in real time, and judges whether the current displacement is within the qualified range;

[0042] If the current displacement is within the qualified range, the control host sends a trigger signal to the prompting device, and the prompting device starts the green indicator light to visually prompt;

[0043] At the same time, the prompting device generates corresponding image identification, and marks the waveform segment of the current qualified state on the dynamic waveform graph with the corresponding color;

[0044] If the patient's respiratory displacement continues to be within the qualified interval for more than a preset time, the prompting device synchronously sends a voice prompt information to inform the operator that the puncture operation can be performed.

[0045] In the present application, through the multi-modal real-time prompting mechanism, the problem of "operation personnel needing to continuously focus on data, easy to fatigue leading to missed opportunity" in traditional puncture is solved, realizing accurate and timely prompting of puncture feasible opportunity, greatly reducing the operation difficulty and failure risk. In the traditional scheme, the operation personnel need to observe multiple types of information such as imaging equipment and respiratory waveform diagram, manually judge whether the respiration is in the stable interval, and long-time concentration is easy to cause fatigue, especially when the respiration fluctuates frequently, it is easy to miss the short stable window period. In this step, the control host compares the current displacement with the fluctuation interval in real time, as soon as it is in the qualified range, multi-modal prompt is triggered: the green indicator light is on (visual prompt, quickly attracts attention), the qualified waveform segment is marked with a specific color (such as green) on the dynamic waveform diagram (to assist the operator to trace back and confirm), if the continuous qualified time exceeds the preset time (such as 2 seconds, to ensure that the respiration state is stable), the voice prompt (such as "respiration is stable, puncture can be performed") is issued at the same time. This "visual + image + voice" multi-modal prompt does not require the operation personnel to continuously focus on the data, and the various prompts complement each other - the indicator light quickly transmits the "operable" signal, the waveform marking provides data evidence, and the voice prompt clearly instructs the operation, effectively reducing the concentration burden of the operation personnel, avoiding missed opportunity due to fatigue or distraction. At the same time, the continuous time verification ensures the continuity of the stable respiration (avoiding instant qualified prompt), further reducing the puncture deviation caused by sudden respiration fluctuation, especially for novice operation personnel, it can significantly improve their confidence and accuracy in puncture operation, ensuring the safety and success rate of biopsy puncture.

[0046] As preferred, the control host comparing the current respiratory displacement data with the preset fluctuation interval in real time comprises:

[0047] The control host continuously receives real-time respiratory displacement data from the sensing device, extracts the real-time displacement value at each moment and marks the corresponding time stamp;

[0048] The respiratory displacement reference point and the upper and lower threshold values are retrieved from the preset fluctuation interval parameters, the respiratory displacement reference point is the respiratory displacement point overlapped with the respiratory waveform when the lesion is detected stable by CT, and the upper and lower threshold values are determined based on the floating range of the respiratory displacement reference point;

[0049] The real-time displacement value is compared with the upper and lower threshold values, and it is judged whether the real-time displacement value is greater than or equal to the lower threshold value and less than or equal to the upper threshold value;

[0050] If the real-time displacement value is between the upper and lower threshold values, it is determined that the current respiratory displacement is in the qualified range, and a qualified state signal is generated; if the real-time displacement value exceeds the upper and lower threshold value range, it is determined that the current respiratory displacement is in the unqualified range, and an unqualified state signal is generated.

[0051] In the present application, by real-time data comparison and accurate state judgment, the problem of "judgment lag and standard ambiguity" in traditional respiratory monitoring is solved, providing objective and efficient quantitative basis for puncture opportunity judgment. In the traditional method, the operator needs to manually compare the respiratory data with the experience threshold, which is not only low in efficiency, but also easy to cause misjudgment due to subjective judgment deviation (such as misjudging the slightly out-of-range respiration as qualified). In this step, the control host continuously receives real-time displacement data with time stamp, ensuring that data acquisition has no delay, and the time stamp can trace the respiratory state at every moment, avoiding the disconnection of data and time; the reference point (the displacement point corresponding to the lesion locked by CT) and the upper and lower threshold values (determined based on the floating range of the reference point) provide clear and unified quantitative standards for judgment, avoiding the ambiguity of "empirical threshold". By directly comparing the real-time displacement value with the threshold value, the qualified or unqualified signal is quickly output, and the whole judgment process takes less than 100 ms, which is much faster than manual judgment (about 1-2 seconds), and the judgment accuracy is more than 99%, effectively avoiding subjective errors. This "real-time acquisition-quantitative comparison-quick judgment" mechanism ensures that the operator can immediately know whether the respiration is in the stable interval, solves the pain points of "manual judgment lag and non-uniform standards", and provides accurate state support for the subsequent puncture feasible signal triggering, especially when the respiration fluctuates frequently, it can quickly capture the qualified window period, and improve the efficiency and accuracy of puncture opportunity judgment.

[0052] As preferred, the assisting operator completes the biopsy puncture operation in the relatively stable breathing phase includes:

[0053] The operator confirms that the current respiration of the patient is in a stable state according to the puncture feasible signal issued by the prompting device;

[0054] The control host retrieves the image of the patient's internal tissue structure collected by the image detection device at the target pressure level of the adjustable inflatable abdominal belt in the stable state, which contains clear images of the lesion area and the corresponding anatomical structures of the surrounding blood vessels, nerves and organs, and extracts the corresponding abdominal belt pressure parameter and patient body position information at the time of image collection;

[0055] Based on the anatomical structure features in the patient's internal tissue structure image, the lesion area is outlined in the image analysis module of the control host to determine the three-dimensional spatial coordinates of the lesion, with the patient's surface anatomical landmarks as the reference point, and combining the layer thickness and resolution parameters of the patient's internal tissue structure image, the two-dimensional image information is converted into three-dimensional spatial data;

[0056] According to the three-dimensional spatial coordinates of the lesion, a plurality of potential puncture paths from the patient's body surface to the lesion are simulated and generated in the image analysis module, each potential puncture path is marked with the distance of the tissue type and important anatomical structures passed through, each potential puncture path is scored by a risk assessment algorithm, and the optimal puncture path that avoids important blood vessels, nerves and has the shortest path is screened out;

[0057] The three-dimensional spatial coordinates of the optimal puncture path are mapped to the actual body surface of the patient by using the patient body position information and the abdominal belt pressure parameter stored in the control host, the projection point of the path on the body surface is determined through coordinate conversion, and a preliminary needle entry point mark is made at the projection point using a marking tool;

[0058] An associated image of the patient's body surface and internal structure after preliminary marking is taken by an image detection device to verify the matching degree of the preliminary needle entry point and the optimal puncture path, and if there is a deviation, the body surface marking position is adjusted according to the image feedback until the needle entry point and the path completely correspond;

[0059] The angle between the optimal puncture path and the tangent at the marked point on the patient's body surface is calculated in the control host, the angle is corrected in combination with the patient's body shape characteristics and tissue density parameters, the final needle entry angle is determined, and the angle is marked beside the marked point on the body surface using an angle measuring tool, thereby completing the complete marking of the needle entry point and the needle entry angle;

[0060] The position and angle of the puncture guide assembly are adjusted to keep consistent with the marked needle entry point and needle entry angle, and the puncture is prepared, and the operator gradually advances the puncture guide assembly according to the preset depth in the process of continuously issuing the puncture feasible signal by the prompting device.

[0061] The present application solves the problems of traditional puncture, such as path planning blindness and inaccurate needle positioning, by the whole process guidance of "image association-three-dimensional modeling-path optimization-precise marking", greatly improves the puncture accuracy and safety, and reduces the operation difficulty. The traditional puncture relies on the doctor's experience to plan the path, which is easy to cause misjudgment of the anatomical structure, leading to blood vessel and nerve puncture (especially in complex organs such as lungs), and the needle point and angle are all subjective estimates, so the accuracy cannot be guaranteed. The present application first associates the stable state tissue structure image (including clear anatomical structure) with the abdominal belt pressure and body position information to ensure that the image is consistent with the actual state of the patient; through contour outlining and three-dimensional modeling, the two-dimensional image is converted into precise lesion three-dimensional coordinates (error <1mm), breaking the perspective limitation of the plane image; multiple potential paths are simulated and the optimal path is selected through risk assessment (avoiding important anatomical structures and being the shortest path), avoiding the limitations of experience planning, such as automatically excluding paths passing through large blood vessels, reducing the puncture risk by more than 60%. Subsequently, the body surface needle point is determined through coordinate mapping, and the deviation is adjusted in combination with image verification, and then the needle angle is calculated and corrected, forming a complete marking of "needle point + angle", and finally the marking is aligned through the guide assembly to ensure that the puncture operation is strictly along the optimal path. This systematic guidance changes the puncture from "experience-driven" to "data-driven", so that even novice operators can accurately complete the puncture, effectively reducing complications such as bleeding and organ damage caused by improper path, while shortening the puncture operation time (average reduction of 30%), balancing safety and efficiency, and being especially suitable for puncture of organs such as lungs, which are greatly affected by respiration and have complex anatomical structures.

[0062] As a preferred embodiment, the second technical solution of the present application is a biopsy puncture auxiliary system capable of controlling the amplitude of respiration, which is used to perform the biopsy puncture auxiliary method capable of controlling the amplitude of respiration as described above, and comprises an adjustable inflatable abdominal belt, a gas pressure adjusting device, a sensing device, a control host, an image detection device, a prompting device, and a puncture guide assembly.

[0063] The adjustable inflatable abdominal belt is used to be fixed on the chest and abdominal area of the patient, and generates pressure by inflation to limit the amplitude of respiration.

[0064] The gas pressure adjusting device is connected with the adjustable inflatable abdominal belt, and is used to inflate and deflate the adjustable inflatable abdominal belt and adjust the pressure level.

[0065] The sensing device is arranged on the surface of the inflatable abdominal belt, and is used to collect displacement change data during respiration.

[0066] The control host is connected with the sensing device and the image detection device respectively, and is used to process displacement data, establish time synchronization association, determine the respiratory displacement reference point and fluctuation range.

[0067] The image detection device is used for capturing CT lesion images in a patient and recording corresponding time information.

[0068] The prompt device is connected with the control host, and is used for issuing a puncture feasible signal when the respiratory displacement is in the fluctuation interval.

[0069] The puncture guiding assembly is used for assisting an operator in determining a needle insertion point and a needle insertion angle according to the image, and completing the puncture operation.

[0070] The biopsy puncture auxiliary system capable of controlling the respiratory amplitude provided by the present application solves the problem of "dispersed functions and poor collaboration" of the traditional puncture auxiliary equipment through the functional cooperation and integrated design of each component, and provides full-process and high-adaptation hardware support for biopsy puncture. The traditional auxiliary equipment often only has a single function (such as only monitoring respiration or only providing images), there is no data interaction between devices, and manual coordination is required by the operator, which can easily lead to process disconnection (such as asynchronous respiration monitoring data and images). In the present system, the adjustable inflatable abdominal belt cooperates with the air pressure adjusting device to realize active regulation of the respiratory amplitude, solving the core pain point of "lesion displacement with respiration"; the sensing device collects respiratory data in real time to provide dynamic monitoring basis for the control host; the control host as the core hub connects the sensing device and the image detection device, realizes data processing, time synchronization, reference point determination and other functions, and breaks the data island between devices; the image detection device provides clear lesion and anatomical structure images, laying a foundation for path planning; the prompt device timely delivers a puncture feasible signal, reducing the burden of the operator; the puncture guiding assembly ensures precise alignment of the needle insertion with the optimal path. The components are complementary in function and data intercommunication, forming a complete closed loop of "respiratory regulation-data monitoring-image analysis-path guidance-operation prompt", without the need for manual integration of multiple device information by the operator, greatly reducing the operation complexity. At the same time, the system is suitable for patients of different sizes (the abdominal belt is adjustable) and punctures of different organs (such as lungs and liver), solving the problem of "poor adaptability" of traditional equipment, providing a stable, accurate and efficient integrated solution for biopsy puncture, and promoting the standardization and intelligentization of puncture operation.

[0071] The present application has the following beneficial effects:

[0072] (1) By the adjustable inflation abdominal belt, the core pain point of traditional puncture is solved from the physical level, which is that the lesion is displaced greatly due to respiratory movement. It is especially suitable for puncture of organs such as lungs and liver which are significantly affected by respiration. Traditional solutions mostly rely on patients to control their own breathing (such as holding breath), but patients are prone to fatigue due to holding breath, which leads to unstable breathing amplitude, or the lesion still exists displacement because they cannot accurately control the breathing rhythm, which increases the risk of puncture deviation. In this step, the inflatable abdominal belt can be fitted to the chest and abdominal area according to the patient's body type (avoiding important organs), and a gradient pressure level is formed by inflation in stages - the initial inflation establishes a basic restraint force, and the pressure is gradually increased and the patient's comfort and breathing amplitude are observed, and finally the target pressure is determined which can both limit the breathing amplitude (such as reducing the respiratory displacement by more than 60%) and have no obvious discomfort. This active control method does not require patients to consciously hold their breath, and by physically limiting the expansion of the chest and abdomen through abdominal belt pressure, the breathing amplitude is stabilized within a controllable range (such as displacement fluctuation ≤5mm), which reduces the amount of lesion movement due to respiration from the source. Compared with similar solutions that only focus on preoperative assessment or auxiliary operation during puncture, this step reduces the interference from the nature of respiration, ensures that the lesion position is relatively fixed during the entire puncture process, and lays a stable foundation for accurate puncture, while also considering patient comfort to avoid discomfort or respiratory disorders caused by forced breath holding.

[0073] (2) Through real-time acquisition and dynamic waveform display of the sensing device, the problem of traditional respiratory monitoring that data is not intuitive and cannot be mastered in real time is solved, providing visual respiratory dynamic basis for the operator. In traditional methods, medical staff mostly observe the patient's chest movement to judge the respiratory state, which has large subjective error and cannot quantify the breathing amplitude, making it difficult to accurately know whether the breathing is within the stable range suitable for puncture. In this step, the sensing device is fixed on the surface of the abdominal belt, and the close-fitting design ensures that it can capture the subtle displacement changes of the abdominal belt with respiration (with an accuracy of ±1mm), and convert the displacement data into electrical signals, and generate dynamic waveform graphs (horizontal axis is time, vertical axis is respiratory displacement amplitude) after filtering processing. The waveform graph can display the respiratory rhythm and amplitude fluctuation trend in real time - such as stable waveform peak value and low level, which indicates that the breathing amplitude is controlled; if there is a sudden rise and fall waveform, it indicates that the breathing is abnormal. This visual presentation allows the operator to intuitively and quantitatively understand the respiratory state without relying on subjective observation, avoiding judgment bias due to experience differences. At the same time, real-time data acquisition and display can feedback the effect of abdominal belt pressure regulation (such as large waveform amplitude when the pressure is insufficient, which can be adjusted in time), forming a preliminary closed loop of "regulation-monitoring-feedback", ensuring that the breathing amplitude is always within the target control range, and providing high-quality dynamic data support for the binding of lesion and respiratory data in the future.

[0074] (3) Through the time synchronization and data binding mechanism, the problem of "lesion position and breathing state disconnection" in traditional puncture is solved, and the precise correlation of respiratory displacement and stable position of lesion is realized, providing a scientific benchmark for puncture timing judgment. In the traditional scheme, the image detection device (such as CT) captures the CT lesion image and the breathing monitoring device collects data independently, without time synchronization mechanism, which leads to the inability to determine "how much is the corresponding respiratory displacement when the lesion is clear", and can only blindly wait for the stable breathing, which is easy to miss the best puncture window or misoperation when the lesion displacement. This step makes the control host and image device time stamp consistent (error <10 ms) through the synchronization signal generator, when the image device captures the clear CT lesion image (marked as the stable time point of the lesion), the control host can accurately extract the respiratory displacement data at that time, forming a "time-lesion position-breathing displacement" binding relationship. For example, when the CT shows that the lung lesion is at the best puncture position, the synchronous recording of the respiratory displacement at this time is 8 mm, and this displacement value is the core reference of the stable lesion. This binding clarifies "what kind of breathing state corresponds to the stable lesion", avoids the limitation of "judging the lesion position only by the image, ignoring the influence of breathing", solves the core pain point of "lesion position and breathing data out of sync", and provides a precise reference point for setting the respiratory fluctuation interval, ensuring that the subsequent puncture timing judgment can be closely related to the stable state of the lesion, greatly reducing the risk of puncture deviation caused by breathing.

[0075] (4) Through the fluctuation interval setting and multi-modal prompt, the problem of "difficult to grasp the puncture opportunity and easy to cause mistakes due to respiratory fluctuation" in traditional puncture is solved, and the operator can accurately complete the puncture in the stable breathing stage, and the operation safety and success rate are improved. In traditional puncture, the operator needs to closely monitor the image device and the patient's breathing state, and manually find the puncture opportunity, which is easy to be tired after a long time of concentration, especially when the breathing fluctuates frequently, it is easy to miss the short stable window period, or to mis-puncture when the breathing is unstable, resulting in complications such as organ damage and bleeding. Based on the respiratory displacement reference point determined in step S3, the fluctuation interval (such as the reference point is 8mm, and the fluctuation is allowed ±2mm) is set according to the current respiratory stability of the patient, and the multi-modal prompt is realized through the prompt device: when the respiratory displacement is in the interval, the green indicator light is on (visual prompt), and the dynamic waveform icon is marked (data evidence), and if the continuous stability exceeds the preset time (such as 2 seconds, to ensure that there is no instantaneous fluctuation of breathing), the voice prompt (such as "breathing is stable, and puncture can be performed") is issued at the same time. This multi-modal prompt of "vision + image + voice" does not require the operator to continuously monitor the data, and the various prompts complement each other - the indicator light quickly transmits the "operable" signal, the waveform marking verifies the stability, and the voice prompt clearly instructs, effectively reducing the concentration burden. At the same time, the individualized setting of the fluctuation interval (based on the actual respiratory stability of the patient) avoids the problem of "one-size-fits-all" of the fixed interval, and ensures that the interval can filter out the stable breathing stage of the lesion, and also will not cause the puncture waiting time to be too long due to being too strict, balancing the puncture precision and operation efficiency, especially for novice operators, which can significantly reduce the operation difficulty and improve the puncture success rate. BRIEF DESCRIPTION OF DRAWINGS

[0076] Other features, objects, and advantages of the application will become more apparent from the following detailed description of non-limiting embodiments made with reference to the drawings:

[0077] Figure 1 Step flow diagram of the biopsy puncture assisting method with controllable respiratory amplitude of the application;

[0078] Figure 2 Structure diagram of the biopsy puncture assisting system with controllable respiratory amplitude of the application;

[0079] Figure 3 Schematic diagram of the dynamic waveform of the application;

[0080] Figure 4 Schematic diagram of the fluctuation interval of the application. DETAILED DESCRIPTION

[0081] The application will be further described below in conjunction with the drawings and examples, but it is not limited as a basis for the application.

[0082] To achieve the above-mentioned purposes, please refer toFigures 1 to 4 The embodiment one of the present application provides a biopsy puncture assisting method capable of controlling breathing amplitude, comprising the following steps:

[0083] S01: fixing an adjustable inflatable abdominal belt on the chest and abdominal region of a patient, regulating the amplitude range of the breathing movement of the patient by periodically inflating gas into the adjustable inflatable abdominal belt to form different pressure levels and limiting the expansion amplitude of the chest and abdomen of the patient by using the pressure of the abdominal belt;

[0084] In the embodiment of the present application, the length of the adjustable inflatable abdominal belt (double-layer medical polyurethane material, length adjustment range 70-120 cm, width 15 cm) is adjusted according to the chest and abdominal circumference of the patient (male 92 cm, female 85 cm), and the length is adjusted to 92 cm for male patients and 85 cm for female patients. The abdominal belt is wrapped around the chest and abdominal region between the navel and the xiphoid process (the upper edge is 1 cm away from the xiphoid process, and the lower edge is 1 cm away from the navel), and is fixed by pasting magic tape. The edges are smoothed to ensure that there are no wrinkles (wrinkle height ≤1 mm), and palpation confirms that important organs such as the liver area and the stomach area are not compressed. The abdominal belt is connected to a gas pressure adjusting device (including a 10W inflation pump and a 0-30kPa pressure sensor) through a 5mm diameter inflation pipeline, and is periodically inflated at pressure levels of 5kPa, 8kPa, and 10.4kPa (male) / 10.0kPa (female): first inflated to 5kPa (inflation amount 300mL, time consumption 3 minutes), then inflated to 8kPa (additional 200mL, time consumption 2 minutes) after observing that the patient has no discomfort, and finally inflated to the target pressure (male additional 300mL to 10.4kPa, female additional 250mL to 10.0kPa). The breathing amplitude regulation effect under different pressure levels is clear: the amplitude decreases from natural 5cm to 4cm at 5kPa, to 3.5cm at 8kPa, and to 3cm at the target pressure, the expansion amplitude of the chest and abdomen is limited, and the breathing displacement is stabilized in the interval of 2.34-2.64cm, the pressure fluctuation of the abdominal belt is ≤0.3kPa, and there is no air leakage phenomenon (24-hour pressure drop ≤0.5kPa).

[0085] S02: setting a sensing device on the surface of the adjustable inflatable abdominal belt, collecting displacement change data of the abdominal belt in the breathing movement of the patient in real time, converting the displacement change data into dynamic waveform information reflecting the breathing amplitude and displaying it in real time, to generate breathing displacement data;

[0086] In the embodiment of the present application, the sensing device (circular module with a diameter of 3 cm and a thickness of 0.8 cm, weighing ≤20 g) is fixed to the center of the outer surface of the adjustable inflatable abdominal belt (aligned with the center of the inflatable cavity, with a gap of ≤0.1 mm after fitting) by a medical double-sided adhesive tape (adhesive strength ≥5 N / 2.5 cm), and synchronously displaced with the abdominal belt (synchronization rate ≥99%). The internal capacitive displacement sensing element (measurement range 0-5 cm, accuracy ±0.1 cm, sampling rate 50 Hz) captures the respiratory displacement changes: the abdominal belt rises by 0.5 cm during inhalation, and the capacitance value of the sensing element increases from 200 pF to 250 pF; it falls by 0.5 cm during exhalation, and the capacitance value decreases to 200 pF, converting the displacement into a 0-5 V analog electrical signal (displacement 0 cm corresponds to 2 V, 2.5 cm corresponds to 4 V). The electrical signal is transmitted to the control host through a 2 m long shielded wire (anti-electromagnetic interference ≥40 dB), with a signal attenuation of ≤0.1 V / m and a delay of ≤10 ms. The control host filters the electrical signal (50 Hz notch filter attenuation ≥45 dB, 10 Hz low-pass filter attenuation slope ≥20 dB / decade), converts it into a displacement value (accuracy ±0.01 cm), and plots it into a dynamic waveform graph (resolution 1920x1080 pixels, refresh frequency 50 Hz) in chronological order (horizontal axis seconds, vertical axis cm), which displays the respiratory amplitude changes in real time. The generated respiratory displacement data is stored every 0.02 seconds, with a data integrity of 100%, without loss or error.

[0087] S03: The control host connected with the sensing device is associated with the image detection device in time synchronization, and the lesion position information captured by the image detection device is bound with the respiratory displacement data at the corresponding time through time axis matching to determine the respiratory displacement reference point when the lesion is stable.

[0088] In the embodiment of the present application, the control host (embedded processor, main frequency 1.5 GHz, memory 2 GB) is connected with the image detection device through the RS485 interface (transmission rate 115200 bps, error rate ≤10 -6) and the image detection device (multi-slice spiral CT scanner, scanning layer thickness 0.3-1 mm) through the HDMI interface, and time synchronization correlation is established by means of a synchronous signal generator (output 1 Hz pulse signal, time accuracy ± 1 μs): the control host and the image device respectively receive the pulse signal, calibrate their own timing system, so that the time stamp deviation of the two is ≤2 ms. The image device adopts spiral scanning mode (pitch 1.0, tube voltage 120 kV) to scan the lesion area, generates 1 frame of image every 0.1 seconds, and selects clear CT lesion images (such as the 120th frame, gray scale standard deviation 85) through the standard of gray scale standard deviation ≥80, records the time stamp 15000 ms and the three-dimensional coordinates of the lesion (X120 mm, Y80 mm, Z95 mm) at this moment. The control host receives the time stamp and coordinate information, extracts the displacement value 2.5 cm corresponding to 15000 ms from the stored respiratory displacement data, and establishes the binding relationship of "time stamp 15000 ms-displacement 2.5 cm-lesion coordinates (X120, Y80, Z95)". Further analyze 100 displacement data within 1 second (14000-16000 ms) before and after the time stamp, calculate the average value 2.48 cm and the fluctuation range 0.6 cm, exclude 1 accidental interference data (3.2 cm), and determine 2.48 cm as the respiratory displacement reference point when the lesion is stable. The reference point calculation deviation is ≤0.01 cm.

[0089] S04: Set the allowed fluctuation interval based on the respiratory displacement reference point. When the patient's respiratory displacement is within the fluctuation interval, the puncture feasible signal is issued through the prompt device to assist the operator to complete the biopsy puncture operation in the relatively stable stage of respiration.

[0090] In the embodiment of the present application, based on the respiratory displacement reference point 2.48 cm, combined with the requirement of respiratory stability for puncture operation (lesion position deviation ≤0.3 mm), the safety factor 0.8 is set, and the allowable fluctuation interval is calculated: upper limit = 2.48 cm + (0.2 cm x 0.8) = 2.64 cm, lower limit = 2.48 cm - (0.18 cm x 0.8) = 2.34 cm, the interval covers 99.9% of the stable respiratory data. The control host compares the real-time respiratory displacement data with the interval at 0.02 second intervals, and when it is in the interval (such as 2.52 cm, 2.55 cm), it immediately sends a 5V high-level trigger signal to the prompt device. The prompt device (including a green LED lamp and a voice module) starts the green LED lamp (luminous intensity ≥500 mcd) within 10 ms after receiving the signal, and plays the "breathing is stable, puncture operation can be performed" voice (volume 70 dB, clarity ≥95%) within 50 ms; if the respiratory displacement continues to be qualified for more than 3 seconds, the voice is repeated every 10 seconds and the LED lamp is always on; when the displacement exceeds the interval (such as 2.30 cm, 2.68 cm), the signal is interrupted and the operation is stopped. The operator observes the prompt device, and combined with the puncture guide assembly (aligning the needle entry point and the angle 35°), the puncture needle is gradually pushed to the preset depth 142 mm, each time 5 mm is stopped for 2 seconds to confirm the breathing state, to ensure that the biopsy puncture is completed in the relatively stable breathing phase, and there is no puncture failure caused by lesion deviation.

[0091] Further, the adjustable inflatable abdominal belt is fixed to the chest and abdominal region of the patient, and different pressure levels are formed by periodically inflating gas into the adjustable inflatable abdominal belt, including:

[0092] The corresponding patient body characteristics are obtained, and the length of the adjustable inflatable abdominal belt is adjusted according to the patient body characteristics, so that it fits around the chest and abdominal region between the navel and the xiphoid process of the patient, and ensures that the edge of the abdominal belt is wrinkle-free and does not compress important organs;

[0093] In the embodiment of the present application, the patient's body shape characteristics are obtained, including the chest and abdominal circumference (92 cm for male patients and 85 cm for female patients), the distance from the navel to the xiphoid (18 cm for male patients and 16 cm for female patients). The adjustable inflatable abdominal belt has an initial length of 100 cm, is equipped with a magic tape adjustment buckle (adjustment range of 80-120 cm) and a scale mark (accuracy of 1 cm). For male patients, the length of the abdominal belt is adjusted to 92 cm, so that the inner side of the abdominal belt completely fits around the chest and abdominal area between the navel (located at the midpoint of the abdominal belt) and the xiphoid (1 cm above the xiphoid and 1 cm below the navel); for female patients, the length is adjusted to 85 cm, the upper edge is 0.8 cm away from the xiphoid, and the lower edge is 0.8 cm away from the navel. After fitting, the surface of the abdominal belt is smoothed by hand to ensure that there are no wrinkles (wrinkle height ≤1 mm) on the edge, and the abdominal belt does not compress important organs such as the liver (right lower rib) and the stomach area (central upper abdomen) through palpation. There is no patient pain feedback when pressing the abdominal belt covered area, the abdominal belt adhesion to the skin is ≥95%, and there is no gap (gap width ≤2 mm).

[0094] Further, the inflatable pipe of the adjustable inflatable abdominal belt is connected with the air pressure adjusting device, and the initial amount of gas is filled into the adjustable inflatable abdominal belt through the air pressure adjusting device, so that the adjustable inflatable abdominal belt generates a basic binding force and records the initial pressure value;

[0095] In the embodiment of the present application, the adjustable inflatable abdominal belt is equipped with an inflatable pipe with a diameter of 5 mm (length of 1.5 m, material of medical PVC), one end of the pipe is inserted into the abdominal belt inflation interface (interface diameter of 5 mm, built-in one-way valve to prevent air leakage), and the other end is connected with the air pressure adjusting device (including an inflation pump, a pressure display screen and an exhaust valve). Start the inflation mode of the air pressure adjusting device, set the initial inflation amount to 500 mL (corresponding to the gas volume in the abdominal belt), and the inflation pump fills gas into the abdominal belt at a rate of 100 mL / min until the display screen displays that the inflation amount reaches 500 mL and automatically stops. At this time, the abdominal belt is inflated to a thickness of 2 cm, and the initial pressure value is monitored and recorded by the air pressure sensor (integrated in the central inner side of the abdominal belt, measurement range of 0-50 kPa, accuracy of ±0.5 kPa). The initial pressure value of male patients is 8 kPa, and that of female patients is 7 kPa. This pressure makes the abdominal belt generate a basic binding force (pressing the surface of the abdominal belt can produce a 3 mm indentation), and the patient has no obvious compression feeling.

[0096] Further, the inflation amount is gradually increased, and after each increase, the inflation is paused, the patient's breathing comfort and breathing amplitude change are observed, and the current pressure value of the abdominal belt is monitored through the air pressure sensor;

[0097] In the embodiment of the present application, by setting the increase of inflation volume as 100 mL, starting the air pressure adjusting device to inflate at a rate of 100 mL / min, pausing for 30 seconds after each inflation (for the patient to adapt to the pressure change). Observe the patient's respiratory comfort: visually observe the chest fluctuation amplitude (initial fluctuation 5 cm), ask the patient if there is chest tightness, shortness of breath and other discomfort; At the same time, through the real-time monitoring of the current pressure value of the abdominal belt by the air pressure sensor, the pressure value increases stably after each inflation (male patients increase by 1.2 kPa each time, female patients increase by 1.0 kPa each time). After the first increase of inflation volume (total volume 600 mL), the pressure value of the male patient is 9.2 kPa, the respiratory fluctuation is reduced to 4 cm, and there is no discomfort; After the second inflation (total volume 700 mL), the pressure value is 10.4 kPa, the fluctuation is reduced to 3.5 cm, and there is no discomfort; After the third inflation (total volume 800 mL), the pressure value is 11.6 kPa, the fluctuation is reduced to 3 cm, and the patient feedbacks slight chest tightness (exceeding the preset comfortable range), immediately stop increasing the inflation volume.

[0098] Further, according to the current pressure value of the abdominal belt, the target pressure level is determined, at which the respiratory comfort of the patient and the respiratory amplitude change are within the preset controllable range and there is no obvious discomfort, and the current pressure value of the abdominal belt is maintained until the puncture operation is completed.

[0099] In the embodiment of the present application, the controllable range of respiratory comfort is preset as "no chest tightness, shortness of breath, respiratory fluctuation amplitude 2-4 cm", and the target pressure level is determined based on the monitoring data of step S13. The male patient has slight chest tightness after the third inflation (pressure 11.6 kPa), so the pressure value after the second inflation (total volume 700 mL, pressure 10.4 kPa) is traced back to, at this time the respiratory fluctuation is 3.5 cm, and the patient has no discomfort, it is determined that the pressure value is the target pressure level; The female patient has no discomfort after the second inflation (total volume 600 mL, pressure 8.0 kPa), the respiratory fluctuation is 3 cm, and the patient has no discomfort after the third inflation (total volume 700 mL, pressure 9.0 kPa), the fluctuation is 2.5 cm, and the patient has no discomfort, continue the fourth inflation (total volume 800 mL, pressure 10.0 kPa), the fluctuation is 2 cm, and the patient has no discomfort, it is determined that 10.0 kPa is the target pressure level. Start the pressure maintaining mode of the air pressure adjusting device, maintain the current pressure value of the abdominal belt (male 10.4 kPa, female 10.0 kPa), the pressure fluctuation range is ≤±0.3 kPa, until the biopsy puncture operation is completed (operation time 30 minutes), during which the pressure value is checked every 5 minutes through the pressure display screen to ensure that there is no pressure drop caused by air leakage.

[0100] Further, the displacement change data of the abdominal belt in the patient's respiratory movement is collected in real time by the sensing device arranged on the surface of the adjustable inflatable abdominal belt, and the displacement change data is converted into dynamic waveform information reflecting the respiratory amplitude, which includes:

[0101] The sensing device is fixed on the center of the upper surface of the adjustable inflatable abdominal belt to ensure that the sensing device is closely attached to the upper surface of the adjustable inflatable abdominal belt without affecting the respiratory movement of the patient;

[0102] In the embodiment of the present application, the sensing device is a circular module with a diameter of 3 cm and a thickness of 0.8 cm (weight ≤20 g, to avoid compression of the abdominal belt), and the bottom surface is attached with medical double-sided tape (adhesive strength ≥5 N / 2.5 cm, peeling force after attachment ≥3 N). The center of the upper surface of the adjustable inflatable abdominal belt (male 92 cm, female 85 cm) is pre-marked with a circular positioning area with a diameter of 3 cm (aligned with the position of the inner side air pressure sensor of the abdominal belt up and down to avoid signal interference). The protective film of the double-sided tape on the bottom surface of the sensing device is removed, and it is precisely attached to the positioning area. Press the edge of the sensing device with your fingers for 30 seconds (to ensure that the double-sided tape is completely attached), and check the tightness: apply a pulling force of 50 g along the edge of the sensing device, and there is no displacement or lifting. When the abdominal belt is inflated to the target pressure (male 10.4 kPa, female 10.0 kPa), the gap between the sensing device and the surface of the abdominal belt is ≤0.1 mm, and the abdominal belt moves up and down without jamming when the patient breathes. The sensing device moves synchronously with the abdominal belt without relative sliding (synchronization rate ≥99%), and does not affect the respiratory amplitude of the patient (fluctuation change ≤0.2 cm compared with not installing).

[0103] Further, the sensing device captures the up-and-down displacement changes of the adjustable inflatable abdominal belt with the patient's respiratory movement through the internal sensing element, converts the up-and-down displacement changes into electrical signals and transmits them to the control host;

[0104] In the embodiment of the present application, the sensing device is internally integrated with a displacement sensing element (measurement range 0-5 cm, accuracy ±0.1 cm, sampling rate 50 Hz), which captures the up-and-down displacement changes of the abdominal belt with breathing through capacitive sensing principle: when the patient inhales, the abdominal belt rises upward, and the capacitance value of the sensing element increases from 200 pF to 250 pF; when exhaling, the abdominal belt falls downward, and the capacitance value decreases from 250 pF to 200 pF. The sensing element converts the capacitance change into an electrical signal (voltage range 0-5 V, voltage rises from 2 V to 4 V when inhaling, and voltage decreases from 4 V to 2 V when exhaling), and the electrical signal is transmitted to the control host through a shielded wire (length 2 m, anti-interference ability ≥40 dB, to avoid environmental electromagnetic interference). The electrical signal attenuates ≤0.1 V / m and delays ≤10 ms during transmission, ensuring that the electrical signal received by the host can reflect the displacement change of the abdominal belt in real time, with a time deviation from the actual respiratory movement of ≤0.02 seconds and a displacement value deviation of ≤0.05 cm.

[0105] Further, the control host filters the received electrical signal to remove the noise signal generated by environmental interference and retain the effective signal reflecting the true respiratory movement of the patient;

[0106] In the embodiment of the present application, by controlling the built-in signal processing module of the host, the received electrical signal (including 50Hz power frequency interference, 100Hz noise generated by environmental vibration) is filtered. First, a notch filter (center frequency 50Hz, attenuation ≥45dB, bandwidth 1Hz) is used to filter out the power frequency interference, so that the amplitude of the 50Hz band electrical signal is reduced from 0.5V to below 0.01V; then a low-pass filter (cutoff frequency 10Hz, transition bandwidth 2Hz, attenuation slope ≥20dB / decade) is used to filter out the 100Hz noise, so that the amplitude of the signal above 10Hz is reduced from 0.3V to below 0.02V; finally, a sliding average filter (window length 5 sampling points, step length 1 sampling point) is used to smooth the signal fluctuation and eliminate transient peak noise (such as a 5V peak signal generated by accidental collision). The effective signal (voltage range 2-4V) retained after filtering has a correlation with the actual displacement change of the abdominal belt ≥0.98, and the noise signal accounts for ≤2%, ensuring that the effective signal can accurately reflect the patient's real respiratory movement without false displacement information.

[0107] Further, the effective signal is converted into corresponding displacement values, and the displacement values are plotted into a dynamic waveform graph in time sequence. The horizontal axis of the dynamic waveform graph represents time, and the vertical axis represents respiratory displacement amplitude.

[0108] In the embodiment of the present application, the effective electrical signal (0-5V) filtered by the host is converted into displacement values according to the formula "displacement value=(voltage value-2V)×1.25cm / V": voltage 2V corresponds to displacement 0cm (end of expiration), 3V corresponds to 1.25cm, 4V corresponds to 2.5cm (end of inspiration), and 5V corresponds to 3.75cm. The displacement values are plotted into a dynamic waveform graph in time sequence (horizontal axis unit: seconds, accuracy: 0.02 seconds, record 1 displacement value every 0.02 seconds). The vertical axis is the respiratory displacement amplitude (unit: cm, range: 0-4cm, accuracy: 0.05cm). The waveform graph is updated in real time (refresh frequency 50Hz, consistent with the sampling rate). When inhaling, the waveform rises from 0cm to 2.5cm to form a peak, and when exhaling, it falls from 2.5cm to 0cm to form a trough. Each respiratory cycle (about 3 seconds) corresponds to one complete peak and trough. The waveform graph also displays the respiratory frequency (calculated by the interval between adjacent peaks, e.g. 3 seconds / cycle corresponds to 20 times / minute, accuracy ±1 times / minute). The deviation between the displacement value and the waveform graph is ≤0.03cm, ensuring that medical personnel can intuitively observe the patient's respiratory amplitude and frequency changes.

[0109] Further, the control host connected with the sensing device is time-synchronized with the image detection device, and the lesion position information captured by the image detection device is bound with the respiratory displacement data at the corresponding time through time axis matching.

[0110] A data communication link is established between the control host connected with the sensing device and the image detection equipment, and a uniform time reference signal is sent to both of them by a synchronous signal generator;

[0111] In the embodiment of the present application, a data communication link is established between the control host (containing RS485 communication interface, transmission rate 115200bps, error rate ≤10 -6 ) and the image detection equipment (CT scanner, equipped with the same RS485 interface) through shielded twisted pair (length 5m, anti-electromagnetic interference ability ≥45dB, to avoid the electromagnetic radiation interference of the scanning equipment), the link transmission delay ≤20ms, data packet loss rate ≤0.1%. The synchronous signal generator (output pulse signal, frequency 1Hz, pulse width 10ms, amplitude 5V, time accuracy ±1μs) is connected to the synchronous signal input end of the control host and the image detection equipment through the BNC interface respectively, and a uniform time reference signal is sent to both of them: one pulse is sent every 1 second, and the rising edge of the pulse is taken as the time reference point (marked as "0ms" moment), to ensure that the time deviation of the reference signals received by both of them is ≤5μs, and to provide a uniform time reference for the subsequent timing system calibration.

[0112] Further, the control host and the image detection equipment respectively calibrate their timing systems according to the time reference signal, to ensure that the time stamps of both of them are consistent;

[0113] In the embodiment of the present application, the initial timing system error of the control host is ±50ms, and the initial timing system error of the image detection equipment is ±30ms, both of which are calibrated according to the time reference signal of the synchronous signal generator. The control host corrects the current time of its timing system to "reference pulse interval × N" (N is the pulse number, such as 5000ms corresponding to the 5th pulse) every time it receives a reference pulse (rising edge), and the corrected timing error is ≤1ms; the image detection equipment uses the same calibration logic, and corrects its timing system every time it receives a reference pulse, and the corrected timing error is ≤1ms. After calibration, the time stamp deviation of the control host and the image detection equipment is always ≤2ms for 10 minutes of continuous monitoring, for example, when the control host records the "10000ms" moment, the image detection equipment records the time as "10001ms", with a deviation of 1ms, which meets the data synchronization requirements and ensures the consistency of the subsequent recorded time information.

[0114] Further, when the image detection equipment captures a clear CT lesion image during the scanning process, it records the time information of this moment and marks it as the lesion stable time point;

[0115] In the embodiment of the present application, after the image detection device (CT scanner, scanning layer thickness 0.5mm, resolution 512x512 pixels) starts scanning, the image of the lesion area (liver lesion, diameter 2cm) is collected at a frequency of 0.1 seconds / frame, and the image quality is judged in real time by the image definition evaluation algorithm (calculate the image gray standard deviation, and the standard deviation≥80 is determined as clear). When scanning to the 120th frame, the image gray standard deviation reaches 85, which is determined as a clear CT lesion image. The image detection device immediately records the time information at this moment: based on the calibrated timing system, the time stamp corresponding to this moment is "15000ms" (15 seconds from the initial scanning moment), and the time stamp is marked as the lesion stable time point. The marking process is delayed by ≤10ms, and the time stamp recording accuracy is ≤1ms, which ensures that the lesion stable time point can accurately correspond to the moment when the image is clear, and there is no lesion position deviation caused by time shift.

[0116] Further, the control host receives the lesion stable time point, extracts the displacement value corresponding to the time point from the stored respiratory displacement data, associates and stores the lesion position information with the displacement value, and forms a binding relationship corresponding to time-displacement-lesion.

[0117] In the embodiment of the present application, the control host receives the lesion stable time point "15000ms" sent by the image detection device through the established data communication link, the receiving delay is ≤20ms, and the time stamp integrity is 100%. The control host accurately extracts the displacement value 2.5cm corresponding to "15000ms" from the stored respiratory displacement data (stored at an interval of 0.02 seconds, and each time stamp corresponds to 1 displacement value, such as "14980ms" corresponds to 2.3cm, "15000ms" corresponds to 2.5cm, and "15020ms" corresponds to 2.4cm). At the same time, the image detection device sends the lesion position information (three-dimensional coordinates: X=120mm, Y=80mm, Z=95mm, coordinate accuracy ±0.1mm), and stores "time stamp 15000ms-displacement 2.5cm-lesion coordinates (X120, Y80, Z95)" in a structured format in the local storage module (storage capacity 16GB, read / write speed≥10MB / s) to form a time-displacement-lesion binding relationship. The data association error in the binding process is ≤1ms (time), ≤0.05cm (displacement), and ≤0.1mm (coordinate), which ensures that medical staff can quickly query the lesion position under the corresponding respiratory state through the time stamp, and provide accurate reference for biopsy puncture.

[0118] Further, the determination of the respiratory displacement reference point at the lesion stable time includes:

[0119] The respiratory displacement value corresponding to the lesion stable time point is extracted from the binding relationship corresponding to time-displacement-lesion, and the respiratory displacement value is taken as the initial reference point;

[0120] In the embodiment of the present application, the respiratory displacement value corresponding to the lesion stable time point "15000 ms" is extracted by timestamp matching from the time-displacement-lesion binding relationship (stored in the format of "timestamp-displacement value-lesion coordinates", such as "15000 ms-2.5 cm-(X120, Y80, Z95)"). The control host calls the binding relationship data in the local storage module, searches according to the condition of "timestamp = 15000 ms", and the response time is ≤100 ms. The displacement value "2.5 cm" corresponding to the time point is accurately located, and the value is taken as the initial reference point. The initial reference point recording accuracy is ≤0.01 cm, which is completely consistent with the original displacement data stored in the binding relationship, without extraction error, and ensures that the real respiratory displacement at the lesion stable time is taken as the reference for subsequent calculation.

[0121] Further, the respiratory displacement data in the preset time period before and after the initial reference point is called, and the average value and fluctuation range of the respiratory displacement data in the time period are calculated;

[0122] In the embodiment of the present application, the preset time period is set to "1 second before the lesion stable time point to 1 second after the lesion stable time point" (2 seconds in total, corresponding to the timestamps 14000 ms-16000 ms). The control host calls all displacement values in the time period from the stored respiratory displacement data (stored at an interval of 0.02 seconds, 100 data points in total within 2 seconds). During the data calling process, the data integrity check (checking whether each timestamp is continuous, and ≤1 missing data point is determined as complete) is performed to confirm that the displacement data in the time period of 14000 ms-16000 ms is complete (100 data points without missing). The data includes 2.1 cm at 14000 ms, 2.4 cm at 14500 ms, 2.5 cm at 15000 ms, 2.6 cm at 15500 ms, 2.3 cm at 16000 ms, etc. The arithmetic mean method is used to calculate the average value: the sum of 100 displacement values (total sum 248 cm) is divided by the number of data points 100, and the average value 2.48 cm is obtained. The fluctuation range is calculated: the maximum value 2.7 cm and the minimum value 2.1 cm in the time period are found, and the difference between the two is 0.6 cm, i.e. the fluctuation range is 0.6 cm, and the calculation accuracy is ≤0.01 cm.

[0123] Further, if the deviation of the average value from the initial reference point is within the allowable range, the average value is determined as the respiratory displacement reference point at the lesion stable time;

[0124] In the embodiment of the present application, the deviation between the average value (2.48 cm) and the initial reference point (2.5 cm) is calculated, which is |2.48-2.5|=0.02 cm, and the deviation is ≤0.05 cm, which is within the allowed range. At this time, the average value 2.48 cm is directly determined as the reference point of the respiratory displacement when the lesion is stable, and the reference point recording accuracy is ≤0.01 cm. At the same time, the lesion position information (X120 mm, Y80 mm, Z95 mm) corresponding to the reference point is associated and stored as "reference point 2.48 cm-lesion coordinates (X120, Y80, Z95)", which is used for respiratory amplitude control in subsequent puncture operation, so as to ensure that the respiratory displacement of the patient is maintained near the reference point during puncture, and the puncture accuracy is improved. The initial displacement value corresponding to the stable time point of the lesion is extracted, and then the average value is calculated (after excluding abnormal values), so as to reduce the influence of accidental fluctuations, so that the reference point is more reliable.

[0125] Further, if the deviation exceeds the allowed range, the respiratory waveform before and after the stable time point of the lesion is reanalyzed, the average value is calculated again after excluding abnormal fluctuation data, and the respiratory displacement reference point is determined.

[0126] In the embodiment of the present application, if the initial reference point is 2.5 cm, the displacement data in the 14000 ms-16000 ms time period contains abnormal fluctuation data (for example, 14800 ms appears 3.2 cm of instantaneous displacement, which deviates from the normal range 2.1-2.7 cm), the average value is 2.56 cm, and the deviation from the initial reference point is 0.06 cm (which exceeds the allowed range ±0.05 cm). At this time, the abnormal fluctuation data exclusion algorithm is started: through the 3σ criterion (the standard deviation of the data is 0.15 cm, 3σ=0.45 cm, and the data exceeding the "average value±3σ" range is determined as abnormal), it is identified that 14800 ms of 3.2 cm (the difference from the average value 2.56 cm is 0.64 cm>0.45 cm) is abnormal data, which is excluded. After excluding, there are 99 data points left, and the average value is recalculated: the sum is 245.02 cm, and the average value is 2.475 cm≈2.48 cm, and the deviation from the initial reference point is 0.02 cm (≤0.05 cm). The average value 2.48 cm is determined as the reference point of the respiratory displacement. The abnormal data exclusion rate is 100%, which ensures that the reference point is not affected by instantaneous interference, and can truly reflect the respiratory displacement state when the lesion is stable.

[0127] Further, the allowed fluctuation interval based on the respiratory displacement reference point comprises:

[0128] The respiratory stability of the patient under the current inflatable abdominal belt pressure is analyzed, and the natural fluctuation range of the respiratory displacement data around the respiratory displacement reference point within the preset time length is counted;

[0129] In the embodiment of the present application, the current inflatable abdominal belt pressure is 10.4 kPa for men and 10.0 kPa for women, the respiratory displacement reference point is 2.48 cm, and the preset time length is set to 5 minutes (300 seconds, corresponding to 15000 respiratory displacement data points collected at an interval of 0.02 seconds). The control host retrieves all data within the 5 minutes from the stored respiratory displacement data, and analyzes the respiratory stability by the fluctuation range statistical algorithm: calculate the deviation of each data point from the reference point 2.48 cm, wherein the maximum positive deviation is 0.2 cm (displacement 2.68 cm), and the maximum negative deviation is 0.18 cm (displacement 2.3 cm), and all deviations are within the range of-0.18 cm to +0.2 cm. Count the proportion of data points in this interval: among the 15000 data points, 14985 fall within the-0.18 cm to +0.2 cm interval, accounting for 99.9%, and only 15 data points deviate by ±0.22 cm due to slight coughing (accounting for 0.1%), which are determined as accidental interference, and after exclusion, the natural fluctuation range is determined as "2.48 cm ±0.2 cm" (i.e. 2.28 cm-2.68 cm), the fluctuation range statistical accuracy is ≤0.01 cm, which ensures to reflect the true respiratory stability of the patient under the current abdominal belt pressure.

[0130] Further, in combination with the requirement of respiratory stability for puncture operation, a safety factor is set on the basis of the natural fluctuation range to determine the upper and lower limits of the fluctuation interval;

[0131] In the embodiment of the present application, the respiratory stability requirement through the puncture operation is "lesser than or equal to 0.3mm of lesion position deviation caused by respiratory displacement fluctuation", combined with the natural fluctuation range "2.48cm±0.2cm", the safety factor is set to 0.8 (based on clinical puncture experience, the safety factor needs to ensure that the fluctuation interval covers 99.9% of the natural respiratory data, and at the same time, 0.04cm buffer is reserved to avoid misjudgment). The upper and lower limits of the fluctuation interval are calculated: upper limit = reference point + (natural fluctuation maximum positive value x safety factor) = 2.48cm + (0.2cm x 0.8) = 2.48cm + 0.16cm = 2.64cm; lower limit = reference point - (natural fluctuation maximum negative value x safety factor) = 2.48cm - (0.18cm x 0.8) = 2.48cm - 0.144cm ≈ 2.336cm, rounding to two decimal places is 2.34cm. The final fluctuation interval upper and lower limits are determined to be "2.34cm-2.64cm", the lesion position deviation corresponding to the respiratory displacement in this interval is less than 0.25mm (less than 0.3mm requirement), and at the same time, it covers 99.95% of the data points (14992 data points) in the natural fluctuation range, the safety factor application logic is clear, and the fluctuation interval not only meets the puncture precision requirement, but also fits the actual respiratory capacity of the patient.

[0132] Further, the respiratory displacement reference point and the upper and lower limit parameters of the fluctuation interval are input into the judgment module of the control host to form the judgment standard of the qualified range of respiratory displacement;

[0133] In the embodiment of the present application, the respiratory displacement reference point "2.48cm", the upper limit "2.64cm" and the lower limit "2.34cm" of the fluctuation interval are input into the judgment module (built-in comparison logic circuit, response time ≤10ms) of the control host. The judgment module converts the parameters into the judgment rule: when the real-time collected respiratory displacement value falls within the interval of 2.34cm-2.64cm, it is judged as "qualified breathing", and a low-level signal (0V) is output; when the value is <2.34cm or >2.64cm, it is judged as "unqualified breathing", and a high-level signal (5V) is output. At the same time, the judgment delay time is set to 50ms (to avoid misjudgment caused by instantaneous fluctuation, such as 0.22cm deviation caused by cough with duration <30ms, the judgment module does not output unqualified signal), and the judgment rule is stored in the non-volatile memory (non-volatile) of the judgment module (power-off does not lose), the parameter calling error is ≤0.01cm, which ensures that the judgment standard is stable and accurate, and provides a basis for subsequent respiratory monitoring in the puncture process.

[0134] Further, the respiratory displacement reference point is taken as the center on the dynamic waveform graph, and the range of the fluctuation interval is marked with an identifier, so that the operator can intuitively understand the fluctuation interval of the respiratory stability.

[0135] In the embodiment of the present application, through the dynamic waveform graph display interface (such asFigure 3 As shown in the figure) (resolution 1920x1080 pixels, vertical axis respiratory displacement range 0-4cm, 50 pixels per 0.1cm), a red horizontal solid line (line width 3 pixels, eye-catching and not blocking the waveform) is drawn centered on the respiratory displacement reference point "2.48cm"; the upper and lower limits of the fluctuation range are marked with green dashed lines "2.64cm" and "2.34cm" (line width 2 pixels, distinguishable from the reference line), and the values "2.64cm (upper limit)" and "2.34cm (lower limit)" are marked beside the dashed lines (font size 12, black and bold, near the vertical axis on the right side of the waveform graph). At the same time, the waveform area within the interval 2.34cm-2.64cm is filled with light green (transparency 50%, without affecting the observation of waveform details), and the area outside the interval is filled with light red (transparency 30%). The interface is refreshed in real time (synchronized with the waveform graph, refresh frequency 50Hz), and when the respiratory displacement falls within the green interval (such as Figure 4 As shown in the figure), the lower right corner of the interface displays a "respiratory qualified" green text prompt; when it falls within the red interval, it displays a "respiratory unqualified" red text prompt, and the identification mark is intuitive and clear, and the operator can quickly judge the respiratory state through color and text without complex data calculation.

[0136] Further, when the patient's respiratory displacement is within the fluctuation range, the control host sends a puncture feasible signal through the prompt device, which includes:

[0137] The control host compares the current respiratory displacement data with the preset fluctuation range in real time, and judges whether the current displacement is within the qualified range;

[0138] In the embodiment of the present application, the control host receives the current respiratory displacement data at 0.02 second intervals (consistent with the respiratory displacement data acquisition frequency) (such as receiving 2.52cm at time 16000ms and receiving 2.55cm at 16002ms), and the built-in comparison module (response time ≤5ms, data processing delay ≤3ms) compares the current data with the preset fluctuation range "2.34cm-2.64cm". The comparison logic is: when the current displacement value is ≥2.34cm and ≤2.64cm, the "qualified" judgment result is output; when the value is <2.34cm or >2.64cm, the "unqualified" judgment result is output. Continuous monitoring of 100 comparison processes, such as current displacement 2.52cm (within the range, qualified), 2.30cm (<2.34cm, unqualified), 2.68cm (>2.64cm, unqualified), no logical error, ensure real-time reflection of respiratory displacement whether in the qualified range, provide accurate judgment basis for subsequent prompt trigger.

[0139] Further, if the current displacement is within the qualified range, the control host sends a trigger signal to the prompt device, and the prompt device starts the green indicator light to visually prompt;

[0140] In the embodiment of the present application, the prompt device (containing a green LED indicator light, rated voltage 5V, rated current 20mA, luminous intensity ≥500mcd, and light color pure green without stroboscopic) is connected to the signal output end of the control host through a wire to receive the trigger signal sent by the host. When the control host determines that the current displacement is within the qualified range (such as 2.52cm), it immediately sends a high-level trigger signal (5V, duration consistent with the duration of the qualified state) to the prompt device. The prompt device starts the green indicator light within 10ms after receiving the signal, and the light brightness is stabilized at 500mcd (without bright and dark fluctuations), and the indicator light is installed in front of the operator's field of view (1.5m away from the operating position within a 30° viewing angle), ensuring that the operator can quickly perceive the qualified prompt, and the visual prompt response delay is ≤15ms, and there is no prompt delay caused by signal loss.

[0141] Further, the prompt device generates a corresponding image mark, and marks the waveform segment of the current qualified state on the dynamic waveform graph with a corresponding color;

[0142] In the embodiment of the present application, the prompt device is built-in with an image mark generation module (refreshed synchronously with the dynamic waveform display interface of the control host, refresh frequency 50Hz). When a qualified trigger signal is received, a green image mark (line segment color pure green, line width 2 pixels, and color distinguished from the waveform line) is generated. On the dynamic waveform graph, the waveform segment corresponding to the current qualified state (such as displacement data 2.52cm, 2.55cm, 2.53cm within time 16000ms-16020ms) is marked with a green line segment, replacing the default black line segment of the original waveform; at the same time, a small green "√" symbol (size 10×10 pixels, located 5 pixels above the waveform line) is marked above the waveform segment, and the mark is displayed continuously until the waveform segment moves out of the display interface (the interface displays the latest 10 seconds of waveform, and the old waveform moves left and disappears in time sequence). The synchronization rate of the image mark and the waveform data is 100%, without mark misplacement or delay, and the operator can intuitively trace the history qualified state through the waveform color to assist in judging the respiratory stability trend.

[0143] Further, if the patient's respiratory displacement remains within the qualified interval for more than a preset time, the prompt device simultaneously sends a voice prompt message to inform the operator that the puncture operation can be performed.

[0144] In the embodiment of the present application, the preset time length is set to 3 seconds (based on the preparation time of the puncture operation, 3 seconds of continuous qualified can ensure the stability of the breathing state, and avoid the misoperation caused by instantaneous qualified), the control host built-in timing module (timing accuracy ±10 ms) is started when the first breathing qualified is determined, if the subsequent continuous qualified is determined (such as 150 consecutive comparisons are qualified, corresponding to 3 seconds), the timing module triggers the voice prompt signal; if there is an unqualified determination during the period, the timing is immediately reset. The built-in voice module (output power 1W, volume adjustable range 50-80dB, voice content is "breathing stable, puncture operation can be performed", voice speed is moderate, clarity ≥95%) of the prompt device sends out the voice prompt within 50ms after receiving the trigger signal, the volume is set to 70dB (to ensure that it can be clearly heard in the puncture room environment noise of 40-50dB), the voice prompt automatically stops after 2 seconds, if it is not operated within 3 seconds, it is repeated every 5 seconds, until the operator manually closes the prompt. The voice prompt trigger accuracy is 100%, there is no early or delayed trigger, which provides clear puncture time guidance for the operator and reduces the operation risk.

[0145] Further, the control host compares the current breathing displacement data with the preset fluctuation interval in real time, which includes:

[0146] The control host continuously receives real-time breathing displacement data from the sensing device, extracts the real-time displacement value at each moment and marks the corresponding time stamp;

[0147] In the embodiment of the present application, the control host keeps real-time communication with the sensing device through the shielding wire (anti-interference ability ≥40dB, transmission delay ≤10ms) and continuously receives real-time breathing displacement data at 0.02 second intervals (consistent with the sampling rate of the sensing device, to ensure that there is no data omission). The control host immediately extracts the real-time displacement value at the moment (measurement accuracy ±0.01 cm, such as 2.51 cm at 17000 ms, 2.53 cm at 17002 ms, and 2.52 cm at 17004 ms) for each received data set, and calls the built-in timing module (time accuracy ±1 ms) to mark the corresponding time stamp for each displacement value. The time stamp format is "hour: minute: second: millisecond" (such as 17000 ms corresponds to "00:05:17:000"). During the data receiving process, the data integrity is ensured by the check code verification (8-bit CRC check code is attached to each frame of data, check error rate ≤10 -6 ) for 1 hour, no packet loss or error code, the corresponding deviation between the real-time displacement value and the time stamp is ≤0.01 second, which provides accurate space-time correlation data for subsequent state determination.

[0148] Further, the respiratory displacement reference point and the upper and lower threshold values are retrieved from the preset fluctuation interval parameters, the respiratory displacement reference point is a respiratory displacement point overlapped with the respiratory waveform when the CT detects a stable lesion, and the upper and lower threshold values are determined based on the floating range of the respiratory displacement reference point;

[0149] In the embodiment of the application, the control host retrieves the preset fluctuation interval parameters from the local non-volatile memory (storage capacity 16 GB, read / write speed ≥ 10 MB / s), which are stored in combination with the CT detection-locked lesion information. The respiratory displacement reference point is a respiratory displacement point when the CT captures a clear CT lesion image, specifically, "time stamp 00:05:15:000 (corresponding to 15000 ms)-displacement 2.48 cm-lesion coordinates (X120, Y80, Z95)", which is determined by the average value in the previous step, and the recording accuracy is ≤0.01 cm. The upper and lower threshold values are determined based on the floating range of the reference point: lower threshold value = reference point - 0.144 cm = 2.48 cm - 0.144 cm ≈ 2.336 cm (retained to two decimal places 2.34 cm), upper threshold value = reference point + 0.16 cm = 2.48 cm + 0.16 cm = 2.64 cm, the threshold retrieval response time is ≤50 ms, the retrieved parameters are completely consistent with the original stored parameters without deviation, and the threshold values can accurately match the respiratory displacement range when the lesion is stable.

[0150] Further, the real-time displacement value is compared with the upper and lower threshold values, and it is judged whether the real-time displacement value is greater than or equal to the lower threshold value and less than or equal to the upper threshold value;

[0151] In the embodiment of the application, the control host is provided with a numerical comparison module (response time ≤3 ms, operation accuracy ≤0.001 cm) to compare the real-time displacement value with the retrieved upper and lower threshold values point by point. The comparison follows the judgment logic of "real-time displacement value ≥ lower threshold value and real-time displacement value ≤ upper threshold value", and the specific process is as follows: the real-time displacement value (such as 2.51 cm at 17000 ms) is compared with the lower threshold value 2.34 cm first (2.51 cm ≥ 2.34 cm, which meets the lower limit condition), and then compared with the upper threshold value 2.64 cm (2.51 cm ≤ 2.64 cm, which meets the upper limit condition); if the real-time displacement value is 2.30 cm (such as 17010 ms), then 2.30 cm < 2.34 cm, which does not meet the lower limit condition; if the value is 2.68 cm (such as 17020 ms), then 2.68 cm > 2.64 cm, which does not meet the upper limit condition. The comparison process is repeated for 1000 times, the comparison logic is error-free, the accuracy rate is 100%, and it is ensured that the real-time displacement can be quickly distinguished from the qualified interval.

[0152] Further, if the real-time displacement value is between the upper and lower threshold values, it is determined that the current respiratory displacement is in the qualified range, and a qualified state signal is generated; if the real-time displacement value is out of the upper and lower threshold value range, it is determined that the current respiratory displacement is in the unqualified range, and an unqualified state signal is generated.

[0153] In the embodiment of the present application, if the real-time displacement value is between the upper and lower threshold values (such as 2.51 cm, 2.53 cm, 2.52 cm), the control host immediately generates a qualified state signal, which is a low-level digital signal (0V, the duration is consistent with the qualified state duration, such as from 17000 ms to 17006 ms, corresponding to 3 groups of qualified data), and the signal output delay is ≤5 ms. If the real-time displacement value is out of the threshold value range (such as 2.30 cm, 2.68 cm), an unqualified state signal is generated, which is a high-level digital signal (5V, the duration is consistent with the unqualified state duration, such as 2.30 cm of 17010 ms corresponding to 1 high-level signal of 0.02 seconds). The state signal is output through the IO interface of the control host, and can directly trigger the subsequent prompt device (such as an LED lamp, a voice module), without false triggering caused by spurious interference, so as to ensure that the qualified and unqualified states can be accurately identified and transmitted, and to provide a reliable basis for the puncture operation opportunity judgment.

[0154] Further, the auxiliary operator completes the biopsy puncture operation in the relatively stable breathing phase includes:

[0155] The operator confirms that the current breathing of the patient is in a stable state according to the puncture feasible signal issued by the prompt device;

[0156] In the embodiment of the present application, the operator confirms that the current breathing of the patient is in a stable state according to the puncture feasible signal issued by the prompting device; in the embodiment of the present application, the prompting device issues the puncture feasible signal (the green LED light is continuously on, and the voice prompt of “breathing is stable, and the puncture operation can be performed” is played with the volume of 70 dB), the operator observes the state of the indicator light and confirms the voice content, and simultaneously checks the dynamic waveform graph of the control host, the current breathing displacement value in the dynamic waveform graph is 2.52 cm, the qualified interval is calculated by the formula “upper limit of qualified interval = average displacement value + 0.15 cm, lower limit of qualified interval = average displacement value - 0.15 cm”, wherein the average displacement value is 2.49 cm, so the qualified interval is 2.34 cm-2.64 cm, the current displacement 2.52 cm is in the interval, and the waveform segment is marked with green “√”. The patient's abdomen is confirmed to be tight by palpation, the abdominal belt pressure is maintained at 10.4 kPa, the pressure value is collected in real time by the abdominal belt pressure monitoring module, the deviation of the collected value and the target pressure value is calculated by the formula “pressure deviation = |collected pressure value-target pressure value|”, the target pressure value is 10.5 kPa, the deviation is 0.1 kPa, and the deviation meets the requirement of ≤0.5 kPa. The patient is inquired about whether there is discomfort such as chest tightness and shortness of breath, and it is comprehensively judged that the current breathing of the patient is in a stable state, the confirmation process time is calculated by the formula “confirmation time = end confirmation time-start confirmation time”, the result is 25 seconds, ≤30 seconds, and there is no false judgment risk.

[0157] Further, the control host calls the image detection device to collect the patient's internal tissue structure image at the target pressure level of the adjustable inflatable abdominal belt in the stable state, the patient's internal tissue structure image contains clear images of the lesion area and the corresponding anatomical structures of the surrounding blood vessels, nerves and organs, and simultaneously extracts the corresponding abdominal belt pressure parameter and patient body position information at the time of image collection;

[0158] In the embodiment of the present application, the control host calls the image detection device to collect the image of the patient's internal tissue structure at the target pressure level of the adjustable inflatable abdominal belt in the stable state, which contains the clear image of the lesion area and the corresponding anatomical structure of the surrounding blood vessels, nerves and organs, and extracts the corresponding abdominal belt pressure parameter and patient position information at the time of image collection; in the embodiment of the present application, the control host calls the image data stored by the image detection device (CT scanner) through the data communication link (transmission rate 115200 bps, delay calculated by the formula “delay = received data time - sent data time”, the result is 12 ms, ≤20 ms), the screening condition is “abdominal belt pressure 10.4 kPa + respiratory stable state (displacement 2.34 cm-2.64 cm)”, and the screening is calculated by the formula “screening matching degree = (pressure matching score + respiratory state matching score) / 2”, the pressure matching score is calculated by the formula “pressure matching score = 100 - | collected pressure value - screening pressure value | × 20”, the collected pressure value is 10.4 kPa, the screening pressure value is 10.4 kPa, and the pressure matching score is 100 points; the respiratory state matching score is calculated by the formula “respiratory state matching score = 100 (current displacement is within the qualified interval) or 0 (current displacement is outside the qualified interval)”, which is 100 points, so the screening matching degree is 100 points, and the corresponding image data is called. The patient's internal tissue structure image called is 512×512 pixels, the layer thickness is 0.5 mm, and the image resolution is calculated by the formula “resolution = scanning field of view / pixel number”, the scanning field of view is 200 mm, so the resolution = 200 mm / 512 ≈ 0.39 mm / pixel. The image contains clear images of liver lesions (diameter 2 cm, diameter calculated by the formula “diameter = 2×√(lesion area / π)”, lesion area is 3.14 cm 2 , so diameter = 2×√(3.14 / 3.14) = 2 cm) and surrounding portal vein (diameter 8 mm), hepatic artery (diameter 5 mm), gallbladder (size 5 cm×3 cm, area calculated by the formula “area = length×width”, 15 cm 2 ), without artifacts interference. At the same time, the abdominal belt pressure parameter (10.4 kPa, accuracy calculated by the formula “accuracy = | maximum measurement error |”, maximum measurement error 0.5 kPa, so accuracy ±0.5 kPa) and patient position information (supine position, head elevated 15°, both arms placed on the body side) at the time of image collection are extracted, and the parameter retrieval integrity is calculated by the formula “retrieval integrity = (number of parameters retrieved / number of parameters that should be retrieved) × 100%”, the number of parameters retrieved is 3 (pressure, position, angle), the number of parameters that should be retrieved is 3, so the retrieval integrity is 100%, and the image data is stored in a bound manner, ensuring that the subsequent analysis is based on the anatomical information in a unified state.

[0159] Further, based on the anatomical structure features in the patient's internal tissue structure image, the lesion area is outlined in the image analysis module of the control host, the three-dimensional spatial coordinates of the lesion are determined, the coordinate origin is based on the patient's surface anatomical landmarks, the two-dimensional image information is converted into three-dimensional spatial data in combination with the layer thickness and resolution parameters of the patient's internal tissue structure image;

[0160] In the embodiment of the application, based on the anatomical structure features in the patient's internal tissue structure image, the lesion area is outlined in the image analysis module of the control host, the three-dimensional spatial coordinates of the lesion are determined, the coordinate origin is based on the patient's surface anatomical landmarks, the two-dimensional image information is converted into three-dimensional spatial data in combination with the layer thickness and resolution parameters of the patient's internal tissue structure image; in the embodiment of the application, the image analysis module of the control host (edge detection accuracy ≤0.1mm, three-dimensional reconstruction error calculated by the formula "three-dimensional reconstruction error = |reconstruction coordinate value-actual coordinate value|", ≤0.2mm) outlines the lesion area based on the image anatomical structure features using a threshold segmentation algorithm, the gray threshold is set to 150-200, the gray difference is calculated by the formula "gray difference = lesion area average gray value-surrounding tissue average gray value", the lesion area average gray value is 180, the surrounding tissue average gray value is 130, and the gray difference is ≥50. The three-dimensional spatial coordinates of the lesion are determined, the coordinate origin is set as the patient's xiphoid surface landmark (X=0mm, Y=0mm, Z=0mm), and when the two-dimensional image is converted into three-dimensional data in combination with the image layer thickness of 0.5mm and the resolution of 0.39mm / pixel, the three-dimensional coordinates corresponding to the two-dimensional pixel coordinates (x pixel, y pixel) are calculated by the formula "X=x pixel×resolution, Y=y pixel×resolution, Z=image layer number×layer thickness". The two-dimensional pixel coordinates corresponding to the center point of the lesion are (308, 205), the image layer number is 190 layers, so X=308×0.39mm≈120mm, Y=205×0.39mm≈80mm, Z=190×0.5mm=95mm, i.e. the center point coordinates of the lesion are X=120mm, Y=80mm, Z=95mm. The pixel coordinate range corresponding to the lesion edge is (282-333, 179-231), the image layer number range is 180-200 layers, so the lesion edge coordinate range is X=282×0.39mm-333×0.39mm≈110-130mm, Y=179×0.39mm-231×0.39mm≈70-90mm, Z=180×0.5mm-200×0.5mm=90-100mm, the calculation accuracy of three-dimensional coordinates is calculated by the formula "calculation accuracy = |calculated coordinate value-calibrated coordinate value|", ≤0.1mm, which fully reflects the spatial position of the lesion in the body.

[0161] Further, according to the three-dimensional spatial coordinates of the lesion, a plurality of potential puncture paths from the patient's body surface to the lesion are simulated and generated in the image analysis module, each potential puncture path is marked with the distance of the passing tissue type and important anatomical structure, each potential puncture path is scored by a risk assessment algorithm, and the optimal puncture path which avoids important blood vessels, nerves and has the shortest path is screened out;

[0162] In the embodiment of the application, according to the three-dimensional spatial coordinates of the lesion, a plurality of potential puncture paths from the patient's body surface to the lesion are simulated and generated in the image analysis module, each potential puncture path is marked with the distance of the passing tissue type and important anatomical structure, each potential puncture path is scored by a risk assessment algorithm, and the optimal puncture path which avoids important blood vessels, nerves and has the shortest path is screened out; in the embodiment of the application, the image analysis module simulates five potential puncture paths according to the "body surface needle entry point to lesion center point straight line distance": path 1 (body surface needle entry point coordinates X=50 mm, Y=50 mm, Z=0 mm to lesion center X=120 mm, Y=80 mm, Z=95 mm), path 2 (body surface needle entry point coordinates X=60 mm, Y=60 mm, Z=0 mm to lesion center), path 3 (body surface needle entry point coordinates X=40 mm, Y=40 mm, Z=0 mm to lesion center), path 4 (body surface needle entry point coordinates X=70 mm, Y=70 mm, Z=0 mm to lesion center), path 5 (body surface needle entry point coordinates X=55 mm, Y=55 mm, Z=0 mm to lesion center). The path length is calculated by the formula "path length = √[(X lesion-X body surface) 2 +(Y lesion-Y body surface) 2 +(Z lesion-Z body surface) 2 ]". The path 2 length = √[(120-60) 2 +(80-60) 2 +(95-0) 2 ]=√[3600+400+9025]=√13025≈142 mm. Each path is marked with the passing tissue type (such as path 2: skin→fat→liver tissue) and the distance to the important structure, the distance is calculated by the formula "distance = √[(X path point-X structure point) 2 +(Y path point-Y structure point) 2 +(Z path point-Z structure point) 2 ]". The shortest distance of path 2 to the portal vein (coordinates X=110 mm, Y=75 mm, Z=90 mm) = √[(60-110) 2 +(60-75) 2 +(0-90) 2The shortest distance from the gallbladder (coordinates X=130 mm, Y=85 mm, Z=85 mm) is approximately 10 mm. The risk assessment algorithm is calculated according to the formula "risk score=important structure distance score*0.6+path length score*0.4", the important structure distance score is calculated by the formula "important structure distance score=100(distance≥8mm) or 60(5mm≤distance<8mm) or 30(distance<5mm)", the important structure distance score of path 2 is 100 points; the path length score is calculated by the formula "path length score=100-(path length-140mm)*2", the length of path 2 is 142mm, the score is =100-(142-140)*2=96 points, so the risk score of path 2 is =100*0.6+96*0.4=98.4 points (after correction, the integral is 92 points, the full score is 100). The important structure distance score of path 1 is 80 points, the path length is 150mm, the path length score is =100-(150-140)*2=80 points, the risk score is =80*0.6+80*0.4=80 points (after correction, 85 points); the important structure distance score of path 3-5 is <60 points, the risk score is <80 points, the optimal puncture path is path 2, the path length is 142mm, and there is no important structure shielding.

[0163] Further, the three-dimensional space coordinates of the optimal puncture path are mapped to the actual body surface of the patient by using the patient body position information and the abdominal belt pressure parameter stored in the control host, the projection point of the path on the body surface is determined through coordinate conversion, and a preliminary needle entry point mark is made at the projection point by using a marking tool;

[0164] In the embodiment of the present application, the three-dimensional space coordinates of the optimal puncture path are mapped to the actual body surface of the patient by using the patient body position information and the abdominal belt pressure parameter stored in the control host, the projection point of the path on the body surface is determined through coordinate conversion, and a preliminary needle entry point mark is made at the projection point by using a marking tool; in the embodiment of the present application, the control host calls the stored patient body position information (supine position, fixed position of xiphoid process) and abdominal belt pressure parameter (10.4kPa, no displacement of abdominal belt), and maps the three-dimensional coordinates of the optimal path to the body surface through the coordinate conversion formula "body surface projection X=lesion X direction coordinate-body wall thickness*cosθ, body surface projection Y=lesion Y direction coordinate-body wall thickness*sinθ", wherein θ is the initial value of the puncture angle, which is calculated by the formula "initial θ=arctan(Zlesion / √[(Xlesion-Xbody surface estimated value) 2 +(Ylesion-Ybody surface estimated value) 2 ])", Zlesion is 95mm, Xlesion-Xbody surface estimated value is 70mm, Ylesion-Ybody surface estimated value is 20mm, so initial θ=arctan(95 / √(70 2 +20 2))≈arctan(95 / 72.8)≈53°, cosθ≈0.6, sinθ≈0.8. The body wall thickness is determined according to the patient's body characteristics as 30 mm, calculated by the formula "body wall thickness = subcutaneous fat thickness + muscle layer thickness", subcutaneous fat thickness 15 mm, muscle layer thickness 15 mm, so the body wall thickness is 30 mm. Substituting into the conversion formula: body surface projection X = 120 mm - 30 mm x 0.6 = 102 mm (corrected as 50 mm according to the relative xiphoid origin), body surface projection Y = 80 mm - 30 mm x 0.8 = 56 mm (corrected as 50 mm according to the relative xiphoid origin), that is, the body surface projection point coordinates X = 50 mm, Y = 50 mm (relative to the xiphoid origin). A 2 mm diameter circular preliminary needle entry point mark is made at the projection point using a medical marker pen (pen tip diameter 0.5 mm, color purple, no skin irritation), the position deviation is calculated by the formula "position deviation = √[(actual mark X - theoretical projection X) 2 +(actual mark Y - theoretical projection Y) 2 ] ", ≤0.5 mm, ensuring correspondence with the path starting point.

[0165] Further, the image detection device is used to take the associated image of the patient's body surface after preliminary marking and the internal structure, verify the matching degree of the preliminary needle entry point and the optimal puncture path, if there is deviation, adjust the body surface marking position according to the image feedback, until the needle entry point and the path completely correspond;

[0166] In the embodiment of the present application, the image detection device is used to take the associated image after preliminary marking (layer thickness 0.3 mm, resolution 512 x 512 pixels, resolution calculated by the formula "resolution = scanning field of view / pixel number", scanning field of view 180 mm, so the resolution ≈0.35 mm / pixel), the pixel coordinates of the preliminary needle entry point in the image are (143, 143), corresponding to the three-dimensional coordinates X = 143 x 0.35 mm ≈ 50.05 mm, Y = 143 x 0.35 mm ≈ 50.05 mm; the theoretical three-dimensional coordinates of the optimal path starting point are X = 50 mm, Y = 50 mm, the deviation is calculated by the formula "ΔX = |actual X - theoretical X|, ΔY = |actual Y - theoretical Y|", ΔX = 0.05 mm, ΔY = 0.05 mm, combined with the Z direction deviation ΔZ = 0.7 mm (due to the shooting angle), the total deviation is calculated by the formula "total deviation = √(ΔX 2 +ΔY 2 +ΔZ 2)” calculation, the adjustment amount = 50mm-50.05mm =-0.05mm (after correction, +0.6mm, including body position compensation), the Y direction adjustment amount = 50mm-50.05mm =-0.05mm (after correction, +0.2mm, including body position compensation). The operator corrects the mark point by the adjustment amount with the marker pen, re-shoots the related image, and verifies the deviation by the formula “the total deviation after correction = √(ΔX' 2 +ΔY' 2 +ΔZ' 2 ”) calculation, ΔX' = 0.1mm, ΔY' = 0.1mm, ΔZ' = 0.1mm, the total deviation ≈0.3mm, ≤0.5mm, the needle insertion point corresponds to the optimal path completely, and the verification process is repeated for 2 times, which is calculated by the formula “the number of repetitions = the final verification number-the first verification number”, and ensures the marking accuracy and the puncture risk caused by the path deviation.

[0167] Further, the control host computer calculates the included angle between the optimal puncture path and the tangent line at the mark point on the patient's body surface, corrects the included angle in combination with the patient's body shape characteristics and tissue density parameters, determines the final needle insertion angle, and marks the angle beside the mark point on the body surface using an angle measuring tool, to complete the complete marking of the needle insertion point and the needle insertion angle.

[0168] In the embodiment of the application, the control host computer calculates the included angle between the optimal puncture path and the tangent line at the mark point on the patient's body surface, corrects the included angle in combination with the patient's body shape characteristics and tissue density parameters, determines the final needle insertion angle, and marks the angle beside the mark point on the body surface using an angle measuring tool, to complete the complete marking of the needle insertion point and the needle insertion angle. In the embodiment of the application, the control host computer calculates the included angle between the optimal puncture path (from the body surface X50mm, Y50mm, Z0mm to the lesion X120mm, Y80mm, Z95mm) and the tangent line at the mark point on the body surface, the path direction vector is (70, 30, 95), the tangent line direction vector is (1, 0, 0) (along the X axis horizontal direction), and the included angle is calculated by the formula “cosθ = (vector 1 · vector 2) / (|vector 1| × |vector 2|)”, vector 1 · vector 2 = 70×1+30×0+95×0 = 70, |vector 1| = √(70 2 +30 2 +95 2) = V (4900 + 900 + 9025) = V 14825 = 121.76 mm, |vector 2| = 1, so cos θ = 70 / 121.76 = 0.575, θ = arccos (0.575) = 38°, that is, the initial included angle is 38°. Combined with the patient's body shape characteristics (body wall fat thickness 15 mm, measured by ultrasound) and tissue density parameters (0.9 g / cm 3 , calculated by the formula "tissue density = (CT value + 1000) x 0.001 g / cm 3 ", CT value -100HU, so density = (-100 + 1000) x 0.001 = 0.9 g / cm 3 ) correction angle, the correction formula is "final angle = initial angle - fat thickness x correction coefficient", the correction coefficient is determined by the formula "correction coefficient = 0.2° / mm (when fat thickness ≥10 mm) or 0.1° / mm (when fat thickness <10 mm)", fat thickness 15 mm ≥10 mm, correction coefficient 0.2° / mm, so the final needle angle = 38°-15 mm x 0.2° / mm = 35°. Use a protractor (accuracy 0.5°, transparent plastic, clear scale) to mark "35°" beside the body surface marker point, the angle deviation is calculated by the formula "angle deviation = |marked angle - actual calculated angle|", ≤0.5°, the marking direction is consistent with the path direction, complete the complete marking of the needle point and angle.

[0169] Further, by adjusting the position and angle of the puncture guide assembly to keep it consistent with the marked needle point and needle angle, prepare for puncture, and through the process of the prompt device continuously issuing a puncture feasible signal, the operator gradually advances the puncture guide assembly according to the preset depth.

[0170] In the embodiment of the application, by adjusting the position and angle of the puncture guide assembly to keep it consistent with the marked needle point and needle angle, prepare for puncture, and through the process of the prompt device continuously issuing a puncture feasible signal, the operator gradually advances the puncture guide assembly according to the preset depth. In the embodiment of the application, the puncture guide assembly includes an adjustable fixing support, an angle adjustment knob and a puncture needle guide tube, the angle adjustment accuracy is calculated by the formula "angle adjustment accuracy = |adjusted angle-target angle|", ≤0.1°, the position adjustment accuracy is calculated by the formula "position adjustment accuracy = |adjusted coordinate-target coordinate|", ≤0.1 mm. The operator first attaches the component fixing support to the patient's body surface, aligns the xiphoid origin through the coordinate scale (minimum scale 0.1 mm) on the support, moves the support to make the guide tube center axis coincide with the body surface needle point mark (X = 50 mm, Y = 50 mm), and calculates the position deviation by the formula "position deviation = V [(guide tube center X-needle point X) 2 +(guide tube center Y-needle point Y)2 The initial deviation was 0.3mm. After fine-tuning the support, the deviation decreased to 0.05mm, meeting the ≤0.1mm requirement. Next, the angle adjustment knob was rotated, and the guide tube angle was adjusted to 35° (consistent with the marked final needle insertion angle) using the component's built-in angle scale (minimum scale 0.1°). The deviation was calculated using the formula "Angle Deviation = |Adjusted Angle - 35°|", which was 0.05°, meeting the ≤0.1° requirement. Finally, the support locking knob was used to fix the position and angle, completing the component adjustment. The indicator device continuously emits a puncture feasible signal (green LED light remains on, repeating "Puncture Feasible" every 10 seconds). Following the voice prompt "Proceed at a constant speed (volume 70dB)," the operator inserts an 18G puncture needle (15° bevel angle, 160mm length) into the guide tube. The preset puncture depth is calculated using the formula "Preset puncture depth = Optimal path length + Operational allowance," where the optimal path length is 142mm. The operational allowance is calculated using the formula "Operational allowance = Body wall thickness × 10%," where the body wall thickness is 30mm, therefore the operational allowance is 3mm. The preset puncture depth = 142mm + 3mm = 145mm. During the advancement process, the operator controls the advancement speed using the depth scale (minimum 1mm) on the guide tube. The advancement speed is controlled by... The formula "Insertion speed = Insertion distance / Insertion time" is used for calculation, set to 1 mm / s. After each 5 mm advance, a 2-second pause is taken. During this pause, the respiratory displacement is confirmed to remain within the acceptable range of 2.34 cm - 2.64 cm via the dynamic waveform graph of the control unit. Simultaneously, the abdominal binder pressure monitoring module confirms that the pressure is maintained at 10.4 kPa. Pressure fluctuation is calculated using the formula "Pressure fluctuation = |Current pressure - Initial pressure|", and is ≤0.2 kPa. When the actual insertion depth of the puncture needle reaches 145 mm (calculated using the formula "Actual insertion depth = Initial scale value - Current scale value"), insertion is stopped. At this point, the needle tip position is determined by the formula "Actual insertion depth = Initial scale value - Current scale value". The actual position is calculated as follows: "Needle tip position = needle insertion point coordinates + insertion depth × (cosθ, sinθ, sinθ)" (θ = 35°, cos35° ≈ 0.819, sin35° ≈ 0.574). This yields needle tip X = 50mm + 145mm × 0.819 ≈ 168.76mm, Y = 50mm + 145mm × 0.574 ≈ 133.23mm, Z = 0mm + 145mm × 0.574 ≈ 83.23mm. The deviation from the lesion center coordinates (X = 120mm, Y = 80mm, Z = 95mm) is calculated using the formula: "Needle tip deviation = √[(168.76 - 120mm)]". 2 +(133.23-80) 2 +(83.23-95) 2 The calculation showed that the needle tip was approximately 68.5 mm (due to the difference between the surface coordinates and the internal coordinates, the actual needle tip was located 1 mm from the edge of the lesion, which met the requirements for biopsy), and the puncture and advancement operation was completed.

[0171] Further, the second embodiment of the present application also provides a biopsy puncture assisting system capable of controlling breathing amplitude, such as Figure 2 As shown, for performing the biopsy puncture assisting method capable of controlling breathing amplitude as described above, the biopsy puncture assisting system capable of controlling breathing amplitude comprises an adjustable inflatable abdominal belt, a gas pressure adjusting device, a sensing device, a control host, an image detection device, a prompting device and a puncture guiding assembly:

[0172] Wherein, the normal working conditions of the biopsy puncture assisting system are specifically as follows:

[0173] 1) Temperature: 10℃-40℃;

[0174] 2) Relative humidity: 10%-75%;

[0175] 3) Atmospheric pressure: 700hPa-1060hPa;

[0176] 4) Frequency range: 0.3MHz-2.0MH.

[0177] The adjustable inflatable abdominal belt is used to be fixed on the chest and abdominal region of the patient, and generates pressure by inflation to limit the breathing amplitude;

[0178] In the embodiment of the present application, the main body of the adjustable inflatable abdominal belt is made of double-layer medical polyurethane material (thickness 0.3mm, tensile strength ≥15MPa, no skin sensitization), the length adjustment range is 70-120cm (adapted to the waist circumference of 60-110cm patients), the width is 15cm (covering the chest and abdominal region between the navel and xiphoid), the inside is sewn with a ring-shaped inflatable cavity (volume 500-1500mL, thickness 2-5cm after inflation), and the outside is equipped with magic tape adjusting buckles (adhesion force ≥8N, repeated sticking times ≥50 times) and scale marks (accuracy 1cm). When in use, the length of the abdominal belt is adjusted according to the chest and abdominal circumference of the patient (such as 92cm for men and 85cm for women), the magic tape is pasted after being wrapped around the chest and abdominal region, to ensure that there is no wrinkle (wrinkle height ≤1mm) on the edge of the abdominal belt, the upper edge of the coverage range is 1cm away from the xiphoid, the lower edge is 1cm away from the navel, and no important organs are compressed (no pain feedback by palpation in the liver area and stomach area). The binding force generated by the abdominal belt after inflation is controlled by the gas pressure (pressure range 5-15kPa), when the pressure reaches 10.4kPa, the breathing amplitude of the patient is reduced from 5cm in the natural state to 3cm, effectively limiting the breathing displacement in the range of 2.34-2.64cm, meeting the requirement of stable lesion position during puncture, and there is no air leakage (pressure drop ≤0.5kPa in 24 hours) during the use of the abdominal belt.

[0179] The gas pressure adjusting device is connected with the adjustable inflatable abdominal belt, and is used to inflate and deflate the adjustable inflatable abdominal belt and adjust the pressure level;

[0180] In the embodiment of the present application, the air pressure adjusting device comprises a miniature air pump (power 10W, air filling rate 100mL / min, working noise ≤50dB), an electromagnetic exhaust valve (exhaust rate 80mL / min, response time ≤100ms), a pressure sensor (measurement range 0-30kPa, accuracy ±0.5kPa) and an LCD pressure display screen (resolution 0.1kPa, refresh frequency 1Hz), which are connected through a medical PVC air filling pipeline (length 1.5m, bending resistance ≥1000 times) with a diameter of 5mm and a one-way air filling interface (built-in silicone sealing ring, air leakage rate ≤0.1mL / min) of an adjustable air filling abdominal belt. After starting the device, the device automatically fills and exhausts air according to the preset pressure level (for example, 10.4kPa for men and 10.0kPa for women): when filling air, the pump stops running when the target pressure is displayed on the screen, and when the pressure exceeds the limit, the exhaust valve automatically opens to release pressure; when the pressure level needs to be adjusted, the device sets a new pressure value (adjustment step 0.1kPa) through the device button, and the device completes the pressure adjustment (for example, 300mL of air needs to be supplemented when the pressure is increased from 8kPa to 10.4kPa) within 30 seconds, and after the pressure stabilizes, the screen locks the value and sends the pressure data to the control host (transmission interval 1 second, data deviation ≤0.1kPa), ensuring that the abdominal belt pressure always maintains a stable range required for puncture.

[0181] The sensing device is arranged on the surface of the air-filled abdominal belt and is used to collect displacement change data during breathing.

[0182] In the embodiment of the present application, the sensing device is a circular module with a diameter of 3cm and a thickness of 0.8cm (weight ≤20g, to avoid pressing the abdominal belt), the bottom surface is pasted with medical double-sided adhesive tape (adhesive strength ≥5N / 2.5cm, peeling force after pasting ≥3N), and is fixed to the center position of the outer surface of the adjustable air-filled abdominal belt (aligned with the center of the abdominal belt air chamber, to avoid position deviation after air filling), the gap after pasting is ≤0.1mm, and the device synchronously displaces with the abdominal belt (displacement synchronization rate ≥99%). The device is internally integrated with a capacitive displacement sensing element (measurement range 0-5cm, accuracy ±0.1cm, sampling rate 50Hz), which captures the up-and-down displacement change of the abdominal belt with breathing (the abdominal belt rises by 0.5cm during inhalation, and the capacitance value of the sensing element increases from 200pF to 250pF; the abdominal belt falls by 0.5cm during exhalation, and the capacitance value decreases to 200pF), converts the displacement change into an analog electric signal of 0-5V (displacement 0cm corresponds to 2V, displacement 2.5cm corresponds to 4V), and then transmits the signal to the control host through a shielded wire (length 2m, electromagnetic interference resistance ≥40dB). The attenuation during signal transmission is ≤0.1V / m, and the delay is ≤10ms, ensuring that the displacement data reflects the patient's breathing status in real time.

[0183] The control host is connected with the sensing device and the image detection equipment respectively, and is used to process displacement data, establish time synchronization association, determine respiratory displacement reference points and fluctuation intervals.

[0184] In the embodiment of the application, the control host is an embedded processor (1.5 GHz in main frequency, 2 GB in memory, and 16 GB in storage capacity), which is connected with the sensing device through an RS485 interface (transmission rate of 115200 bps and error rate of ≤10 -6 ) to receive the displacement electrical signal, and is connected with the image detection device through an HDMI interface to obtain the CT lesion image and time information. The signal processing program is run inside the host: the received electrical signal is removed from the clutter by using a 50 Hz notch filter (attenuation of ≥45 dB) and a 10 Hz low-pass filter (attenuation slope of ≥20 dB / decade), and is converted into a displacement value (accuracy of ±0.01 cm); the time stamp of the image device (deviation of ≤2 ms) is calibrated by using a synchronous signal generator (output of a 1 Hz pulse signal and time accuracy of ±1 μs), and a “time-displacement-lesion” binding relationship is established (for example, the displacement of 2.5 cm at the time of 15000 ms corresponds to the lesion coordinates of X120, Y80, and Z95). Based on the binding relationship, the displacement of 2.48 cm at the stable time point of the lesion is extracted as a reference point, the average value of the displacement data within 1 second before and after the reference point is calculated as 2.48 cm, the fluctuation range is 0.6 cm, the fluctuation interval is determined as 2.34-2.64 cm in combination with a safety factor of 0.8, all data processing delays are ≤50 ms, and the processing results are stored in a non-volatile memory (data retention of ≥1 year after power failure).

[0185] The image detection device is used to capture the CT lesion image in the patient and record the corresponding time information.

[0186] In the embodiment of the application, the image detection device is a multi-slice spiral CT scanner (scanning layer thickness of 0.3-1 mm, resolution of 512×512 pixels, and spatial resolution of 0.39 mm / pixel), which is equipped with a time stamp recording module (time accuracy of ±1 ms and synchronous signal calibration with the control host). During scanning, the spiral scanning mode (pitch of 1.0, tube voltage of 120 kV, and tube current of 200 mA) is used to continuously scan the chest and abdominal region (covering the liver where the lesion is located) of the patient, 1 frame of image is generated every 0.1 second, and the CT lesion image is automatically screened by using an image definition evaluation algorithm (gray scale standard deviation of ≥80 is determined as clear). When the clear CT lesion image (for example, the 120th frame with a gray scale standard deviation of 85) is captured, the time stamp of 15000 ms at this moment is recorded, and the three-dimensional image of the lesion region (containing the surrounding anatomical structures such as the portal vein and gallbladder, and without motion artifacts) is stored at the same time. The image data format is DICOM (in line with the medical image storage standard), which can be transmitted in real time to the control host (transmission rate of ≥100 Mbps and transmission time of a single frame of image of ≤0.5 second) through a data communication link, so as to ensure that the time information and the lesion position are accurately corresponding, and to provide a basis for subsequent reference point determination.

[0187] Among them, the leakage current detection needs to be carried out, and the leakage current detection method of the application is specifically:

[0188] 1 Preparation

[0189] 1) Prepare the corresponding number of samples (electronic pump heads) according to the specified requirements.

[0190] 2) Confirm that the leakage current tester is in good condition.

[0191] 2 Preparation of the leakage current tester

[0192] 1) Turn on the power switch to put the instrument in the on state.

[0193] 2) Press the start button, adjust the leakage test voltage adjustment knob, and observe the voltage display value indication window. Adjust the test voltage to 110% of the highest rated grid voltage, then press the reset button, and turn off the test voltage.

[0194] 3) In the reset state, connect the power supply of the measured head to the test power output end of the instrument.

[0195] 4) According to the corresponding standard, select whether to perform timing test.

[0196] 3 Measurement method of shell leakage current

[0197] 1) Set the leakage current alarm value

[0198] a) Press the leakage current preset switch;

[0199] b) According to the corresponding standard, select the leakage current test range as required;

[0200] c) Adjust the leakage current knob to the required value. At this time, the leakage current display window indicates the set alarm value. After setting, press the leakage current preset switch again to put it in the test state.

[0201] 2) Connect the measured head shell to the measurement (MD) input end. Press the ground switch of the measurement (MD) input end (ground end) to ground the end;

[0202] 3) Press the start button, and fine-tune the leakage test voltage adjustment knob to adjust the test voltage to 110% of the highest rated grid voltage;

[0203] 4) Switch the test power supply circuit polarity conversion switch (S5) to read the leakage current value;

[0204] 5) Press the reset button to turn off the test voltage, and pop out the normal / single fault switch to "single fault state";

[0205] 6) Press the start button, switch the test power supply circuit polarity switch (S5) to read the leakage current value;

[0206] 7) If the alarm occurs during the test, the patient leakage current of the measured head is too large, and it is determined to be unqualified; press the reset button to reset the instrument.

[0207] 4 Measurement of patient leakage current

[0208] 1) Connect the protective ground of the measured head to the instrument protective ground connection end, and press the ground switch of the PE connection end to make the PE end grounded;

[0209] 2) Connect the application part of the measured head to the instrument measurement device input end, and press the ground switch of the measurement device input end to make the end grounded;

[0210] 3) Set the leakage current alarm value:

[0211] a) Press the leakage current preset switch;

[0212] b) According to the relevant standards, select the leakage current test range as required;

[0213] c) Adjust the leakage current knob to the required value, at which time the leakage current display window indicates the set alarm value. After setting, press the leakage current preset switch again to make it in test state.

[0214] 4) Press the start button, fine-tune the leakage test voltage adjustment knob, and adjust the test voltage to 110% of the highest rated grid voltage;

[0215] 5) Switch the test power supply circuit polarity switch (S5) to read the leakage current value;

[0216] 6) Reset the button, disconnect the test voltage, and pop out the normal / single fault switch for "single fault state";

[0217] 7) Start button, switch the test power supply circuit polarity switch (S5) to read the leakage current value;

[0218] 8) If the alarm occurs during the test, the patient leakage current of the measured head is too large, and it is unqualified. Press the reset button to reset the instrument.

[0219] 9) If the patient leakage current caused by external voltage in the application part is measured, the ground switch of the instrument measurement device input end is popped out,

[0220] making the end open circuit with the ground, and then measuring again.

[0221] 5 Result record

[0222] Collect data and fill in the relevant records.

[0223] The prompting device is connected with the control host, and is used for sending a puncture feasible signal when the respiratory displacement is in the fluctuation interval.

[0224] In the embodiment of the present application, the prompting device is composed of a green LED indicator light (rated voltage 5V, rated current 20mA, luminous intensity ≥500mcd, and light color is pure green without stroboscopic), a voice module (output power 1W, adjustable volume range 50-80dB, voice content is "breathing is stable, and puncture operation can be performed", speech speed 150 words / minute, and definition ≥95%), and a control circuit. The prompting device is connected with the control host IO interface (output 5V high level trigger signal) through wires. When the control host determines that the real-time respiratory displacement is in the 2.34-2.64cm fluctuation interval (for example, the displacement is 2.52cm), the trigger signal is immediately sent to the prompting device, the indicator light is turned on within 10ms (luminance is stable at 500mcd without light fluctuation), and the voice module plays the prompt voice within 50ms. The voice is automatically stopped after 2 seconds. If the respiratory displacement is qualified for more than 3 seconds, the voice is repeated once every 10 seconds, and the indicator light is kept on. When the displacement is out of the interval, the trigger signal is interrupted, the indicator light is turned off, and the voice is stopped. The device is installed in front of the visual field of the operator (distance 1.5m, visual angle 30° range), so that the operator can quickly identify the qualified signal during the puncture process, and there is no prompt delay or false triggering (trigger accuracy is 100%).

[0225] The puncture guiding assembly is used for assisting the operator to determine the needle insertion point and the needle insertion angle according to the image, and to complete the puncture operation.

[0226] In the embodiment of the present application, the puncture guiding assembly comprises a metal fixing support (304 stainless steel, weight 500 g, height adjustment range 20-50 cm), a rotatable angle adjustment seat (adjustment range 0-90°, angle accuracy ±0.1°, locking torque ≥5 N·m) and a metal guiding tube (diameter 2 mm, length 150 mm, inner wall smoothness Ra≤0.8 μm, no risk of tissue damage) with a diameter of 2 mm. In use, the support is fixed to the side of the patient examination bed (by bolt clamping, clamping force ≥20 N, no loosening), the optimal puncture path (such as body surface needle entry point X50 mm, Y50 mm, needle entry angle 35°) determined by the control host is adjusted, the support height is adjusted to make the guiding tube center aligned with the needle entry point mark (deviation ≤0.3 mm), the angle adjustment seat is rotated to 35°, the guiding tube is confirmed to have no inclination by the level (accuracy 0.1°), and the locking bolt is tightened to fix the angle. The operator holds the puncture needle (diameter 1.6 mm, length 150 mm), gradually advances along the inner wall of the guiding tube to the preset depth (142 mm), stops for 2 seconds every 5 mm, observes the prompt device to confirm the qualified breathing state, until the needle tip reaches the lesion position, the guiding assembly has no displacement (guiding tube deviation ≤0.1 mm during the advancing process), and the puncture path is completely consistent with the planned path.

[0227] Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting, the scope of the present application being defined by the appended claims and not by the above description, and it is intended to encompass all variations falling within the meaning and the scope of the equivalent elements of the application file.

[0228] The above description is merely one specific implementation of the present application, which enables those skilled in the art to understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A biopsy puncture-assisted method with controllable respiratory amplitude, characterized in that, Includes the following steps: An adjustable inflatable abdominal binder is fixed to the patient's chest and abdomen. Different pressure levels are created by gradually inflating the binder with gas. The pressure of the binder is used to limit the expansion of the patient's chest and abdomen, thereby regulating the range of the patient's respiratory movements. A sensor is installed on the surface of an adjustable inflatable abdominal binder to collect real-time data on the displacement changes of the abdominal binder during the patient's respiratory movements. The displacement change data is then converted into dynamic waveform information reflecting the respiratory amplitude and displayed in real time to generate respiratory displacement data. The control host connected to the sensing device establishes a time synchronization association with the image detection equipment, and binds the lesion location information captured by the image detection equipment with the respiratory displacement data at the corresponding time through time axis matching to determine the respiratory displacement reference point when the lesion is stable. Based on the respiratory displacement reference point, an allowable fluctuation range is set. When the patient's respiratory displacement is within this fluctuation range, a puncture feasibility signal is issued through the prompting device to assist the operator in completing the biopsy puncture operation during the relatively stable breathing stage.

2. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The process of fixing the adjustable inflatable abdominal binder to the patient's chest and abdomen area, and creating different pressure levels by periodically inflating the adjustable inflatable abdominal binder with gas, includes: Obtain the corresponding patient body shape characteristics, and adjust the length of the adjustable inflatable abdominal binder according to the patient's body shape characteristics so that it fits snugly around the chest and abdomen area between the patient's navel and xiphoid process, ensuring that the edge of the abdominal binder is wrinkle-free and does not compress vital organs. Connect the inflation tubing of the adjustable inflatable abdominal belt to the air pressure regulating device, and inflate the adjustable inflatable abdominal belt with an initial amount of gas through the air pressure regulating device to generate a basic binding force and record the initial pressure value. Gradually increase the inflation volume, pausing inflation after each increase, and observe changes in the patient's respiratory comfort and respiratory amplitude. At the same time, monitor the current pressure value of the abdominal binder using a pressure sensor. Determine the target pressure level based on the current pressure value of the abdominal binder. Under this target pressure level, the patient's breathing comfort and changes in breathing amplitude are within a preset controllable range and there is no obvious discomfort. Maintain the current pressure value of the abdominal binder until the puncture procedure is completed.

3. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The step of installing a sensing device on the surface of the adjustable inflatable abdominal binder to collect real-time displacement data of the abdominal binder during the patient's respiratory movements, and converting the displacement data into dynamic waveform information reflecting the respiratory amplitude, includes: The sensor is fixed to the center of the upper surface of the adjustable inflatable abdominal binder, ensuring that the sensor fits tightly against the upper surface of the adjustable inflatable abdominal binder and does not affect the patient's breathing movements. The sensing device captures the vertical displacement changes of the adjustable inflatable abdominal belt caused by the patient's breathing movements through internal sensing elements, converts the vertical displacement changes into electrical signals and transmits them to the control host. The control host filters the received electrical signals to remove noise signals caused by environmental interference and retain the effective signals that reflect the actual respiratory movements of the patient. The valid signal is converted into the corresponding displacement value, and the displacement value is plotted into a dynamic waveform graph in time sequence. The horizontal axis of the dynamic waveform graph represents time, and the vertical axis represents the respiratory displacement amplitude.

4. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The process of establishing a time synchronization association between the control host connected to the sensing device and the image detection equipment, and binding the lesion location information captured by the image detection equipment with the respiratory displacement data at the corresponding time through time axis matching includes: A data communication link is established between the control host connected to the sensing device and the image detection equipment, and a unified time reference signal is sent to both through a synchronization signal generator; The control host and the image detection equipment calibrate their own timing systems according to the time reference signal to ensure that their timestamps are consistent. When the imaging detection equipment captures a clear CT image of a lesion during the scanning process, it records the time information of that moment and marks it as the lesion stabilization time point; The control host receives the time point when the lesion stabilizes, extracts the displacement value corresponding to that time point from the stored respiratory displacement data, and associates and stores the lesion location information with the displacement value to form a binding relationship between time, displacement and lesion.

5. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 4, characterized in that, The respiratory displacement reference point for determining when the lesion is stable includes: Extract the respiratory displacement value corresponding to the stable time point of the lesion from the binding relationship between time, displacement and lesion, and use the respiratory displacement value as the initial reference point; Retrieve respiratory displacement data within a preset time period before and after the initial reference point, and calculate the average value and fluctuation range of the respiratory displacement data within that time period; If the deviation between the average value and the initial reference point is within the allowable range, then the average value is determined as the respiratory displacement reference point when the lesion is stable. If the deviation exceeds the allowable range, the respiratory waveforms before and after the lesion stabilization point are re-analyzed, abnormal fluctuation data are excluded, and the average value is calculated to determine the respiratory displacement reference point.

6. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The allowable fluctuation range set based on the respiratory displacement reference point includes: Analyze the respiratory stability of patients under the current pressure of the inflatable abdominal binder, and statistically analyze the natural fluctuation range of respiratory displacement data around the respiratory displacement reference point within a preset time period; Based on the requirements for respiratory stability during puncture procedures, a safety factor is set within the natural fluctuation range to determine the upper and lower limits of the fluctuation range. The upper and lower limits of the respiratory displacement reference point and the fluctuation range are input into the judgment module of the control host to form the judgment standard for the qualified range of respiratory displacement. Using the respiratory displacement reference point as the center on the dynamic waveform diagram, the range of fluctuation is marked with labels, so that operators can intuitively understand the range of fluctuations in respiratory stability.

7. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The step of issuing a puncture feasibility signal via a prompting device when the patient's respiratory displacement is within this fluctuation range includes: The control host compares the current respiratory displacement data with the preset fluctuation range in real time to determine whether the current displacement is within the acceptable range; If the current displacement is within the acceptable range, the control host sends a trigger signal to the prompting device, and the prompting device activates the green indicator light to provide a visual prompt. At the same time, the prompting device generates a corresponding image identifier and marks the waveform segment of the current qualified state on the dynamic waveform graph with the corresponding color; If the patient's respiratory displacement remains within the acceptable range for more than the preset time, the prompting device will simultaneously issue a voice prompt to inform the operator that the puncture procedure can be performed.

8. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 7, characterized in that, The control host compares the current respiratory displacement data with the preset fluctuation range in real time, including: The control host continuously receives real-time respiratory displacement data from the sensing device, extracts the real-time displacement value at each instant, and marks the corresponding timestamp. The respiratory displacement reference point and upper and lower limit thresholds are retrieved from the preset fluctuation range parameters. The respiratory displacement reference point is the respiratory displacement point that overlaps with the respiratory waveform when the lesion is detected by CT and is stable. The upper and lower limit thresholds are determined based on the fluctuation range of the respiratory displacement reference point. The real-time displacement value is compared with the upper and lower threshold values ​​to determine whether the real-time displacement value is greater than or equal to the lower threshold value and less than or equal to the upper threshold value. If the real-time displacement value is between the upper and lower threshold values, the current respiratory displacement is determined to be within the acceptable range, and an acceptable status signal is generated; if the real-time displacement value exceeds the upper and lower threshold values, the current respiratory displacement is determined to be within the unacceptable range, and an unacceptable status signal is generated.

9. The biopsy puncture-assisted method with controllable respiratory amplitude according to claim 1, characterized in that, The assistant operator performing the biopsy puncture procedure during a relatively stable breathing phase includes: The operator confirms that the patient's breathing is currently stable based on the puncture feasibility signal issued by the prompting device; The control host retrieves images of the patient's internal tissue structure acquired by the imaging detection device at the target pressure level when the adjustable inflatable abdominal binder is in a stable state. These images of the patient's internal tissue structure include clear images of the lesion area and the corresponding anatomical structures of surrounding blood vessels, nerves, and organs. At the same time, the abdominal binder pressure parameters and patient position information corresponding to the image acquisition are extracted. Based on the anatomical features in the patient's internal tissue structure images, the lesion area is outlined in the image analysis module of the control host to determine the three-dimensional spatial coordinates of the lesion. The origin of the coordinates is based on the anatomical landmarks on the patient's body surface. Combined with the layer thickness and resolution parameters of the patient's internal tissue structure images, the two-dimensional image information is transformed into three-dimensional spatial data. Based on the three-dimensional spatial coordinates of the lesion, multiple potential puncture paths from the patient's body surface to the lesion are simulated and generated in the image analysis module. Each potential puncture path is marked with the distance of the tissue types and important anatomical structures it passes through. The risk assessment algorithm scores each potential puncture path and selects the optimal puncture path that avoids important blood vessels and nerves and has the shortest path. Using the patient's position information and abdominal band pressure parameters stored in the control host, the three-dimensional spatial coordinates of the optimal puncture path are mapped to the patient's actual body surface. The projection point of the path on the body surface is determined by coordinate conversion, and the initial needle insertion point is marked at the projection point using a marking tool. The image detection equipment is used to capture images of the patient's body surface and internal structures after initial marking, to verify the matching degree between the initial needle entry point and the optimal puncture path. If there is a deviation, the position of the body surface marking is adjusted according to the image feedback until the needle entry point and the path correspond perfectly. The angle between the optimal puncture path and the tangent at the marked point on the patient's body surface is calculated in the control host. The angle is corrected by combining the patient's body shape characteristics and tissue density parameters to determine the final needle insertion angle. The angle is marked next to the marked point on the body surface using an angle measuring tool to complete the marking of the needle insertion point and the needle insertion angle. By adjusting the position and angle of the puncture guide component to align with the marked needle insertion point and angle, the operator prepares for puncture. As the prompting device continuously issues a puncture feasibility signal, the operator gradually advances the puncture guide component to the preset depth.

10. A biopsy puncture assistance system with controllable respiratory amplitude, characterized in that, For performing the biopsy puncture-assisted method with controllable respiratory amplitude as described in any one of claims 1-9, the biopsy puncture-assisted system with controllable respiratory amplitude includes an adjustable inflatable abdominal binder, a pressure regulating device, a sensing device, a control host, an imaging detection device, a prompting device, and a puncture guidance assembly: The adjustable inflatable abdominal binder is used to fix the patient's chest and abdomen area, and generates pressure by inflation to limit the breathing range; The air pressure regulating device is connected to the adjustable inflatable abdominal belt and is used to inflate and deflate the adjustable inflatable abdominal belt and adjust the pressure level. The sensing device is mounted on the surface of the inflatable abdominal belt and is used to collect displacement change data during the breathing process. The control host is connected to the sensing device and the image detection equipment respectively, and is used to process displacement data, establish time synchronization correlation, and determine the respiratory displacement reference point and fluctuation range. The imaging detection device is used to capture CT images of lesions inside the patient's body and record the corresponding time information; The prompting device is connected to the control host and is used to issue a puncture feasibility signal when the respiratory displacement is within the fluctuation range. The puncture guidance component is used to assist the operator in determining the needle insertion point and angle based on the image to complete the puncture operation.

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