Clinical puncture sampling device for liver, gall and pancreas

Abstract

The invention discloses a liver, gall and pancreas clinical puncture sampling device in the technical field of medical instruments, which comprises a base, a mechanical arm is fixedly connected to the base, a puncture needle is arranged at the top end of the mechanical arm, a guide rail for mounting the puncture needle is fixedly connected to the top end of the mechanical arm, a pushing part is slidably matched with one side of the guide rail, and the puncture needle is fixedly connected with the pushing part. The base is further fixedly connected with a pump assembly and a fixed arm, the top end of the fixed arm is fixedly connected with a multi-mode integrated sensor, and the side wall of the fixed arm is fixedly connected with a controller. By integrating a plurality of functional layers, the puncture needle can achieve a plurality of functions in single puncture, the mechanical arm is controlled to guide the puncture process of the puncture needle and compensate respiratory movement displacement through model construction and displacement prediction of the controller, and bleeding stopping gel is sprayed in a self-adaptive mode through resistance borne during needle insertion, so that massive bleeding is avoided; therefore, the efficiency of the hepatobiliary pancreas puncture operation is improved, the possibility of tissue bleeding infection is reduced, and the painless treatment experience of a patient is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to a clinical puncture sampling device for hepatobiliary and pancreatic diseases. Background Art

[0002] Hepatobiliary and pancreatic diseases are common and frequently-occurring diseases in clinical practice. Accurately obtaining diseased tissues for pathological examination is crucial for disease diagnosis, typing, and treatment plan formulation. As an important tool for obtaining diseased tissues, the performance of the puncture sampling device directly affects the accuracy of diagnosis and the effectiveness of treatment. With the progress of medical technology, minimally invasive treatment has become an important direction for the treatment of hepatobiliary and pancreatic diseases. As one of the key devices for minimally invasive treatment, the minimally invasive, precision, and safety of the puncture sampling device have become the focus of clinical attention.

[0003] The development of imaging guidance technologies such as ultrasound, CT, and MRI has provided more accurate positioning and navigation for puncture sampling, making the puncture process safer and more effective. These technologies can real-time display the position and path of the puncture needle, helping doctors accurately reach the target site and reducing the occurrence of complications. Moreover, the emergence of robotic-assisted puncture systems and automated puncture devices has further improved the accuracy and stability of puncture. They can reduce the interference of human factors and improve the success rate and safety of the operation.

[0004] Although the existing technologies have been able to perform hepatobiliary and pancreatic punctures stably and accurately, they are all based on ordinary biopsy puncture needles. It is not only difficult to ensure the stability of the relative position between the puncture needle and the lesion, but also requires repeated punctures if multiple treatments are to be performed on the lesion, which brings great harm to the patient's health and experience, as shown in the patent document with publication number CN116138816A. Moreover, the hepatobiliary and pancreatic puncture process often lasts for a period of time, and the patient's normal breathing will cause the displacement of internal organs, making it difficult to ensure the stability of the relative position between the puncture needle and the lesion, and it is easy to deviate the path or tear the wound during needle insertion or sampling, resulting in bleeding and infection. And when puncturing fibrotic tissues, due to the change in hardness, the puncture needle is prone to tear the tissue and cause a large amount of bleeding.

[0005] Therefore, it is necessary to propose a clinical puncture sampling device for hepatobiliary and pancreatic diseases that can intelligently control the puncture guidance process, compensate for the displacement of the patient's respiratory movement, and adaptively spray hemostatic gel during the puncture process to avoid a large amount of bleeding. Summary of the Invention

[0006] To solve the above problems, the object of the present invention is to provide a clinical puncture sampling device for hepatobiliary and pancreatic diseases. By integrating multiple functional layers, the puncture needle can achieve multiple functions in a single puncture. Through the model construction and displacement prediction of the controller, the robotic arm is controlled to guide the puncture process of the puncture needle and compensate for the respiratory movement displacement. The spraying of the hemostatic gel is adaptively controlled by the resistance received by the sliding tube during needle insertion to avoid massive bleeding caused by accidental puncture and fibrotic tissue, thereby improving the efficiency of hepatobiliary and pancreatic puncture surgery, reducing the possibility of tissue bleeding and infection, and enhancing the painless treatment experience of patients.

[0007] To achieve the above object, the technical solution of the present invention is as follows: A clinical puncture sampling device for hepatobiliary and pancreatic diseases, comprising a base, the base is fixedly connected with a robotic arm, the top of the robotic arm is provided with a puncture needle, the top of the robotic arm is fixedly connected with a guide rail for installing the puncture needle, a pushing member is slidably engaged with a side of the guide rail away from the head of the puncture needle, the puncture needle is fixedly connected with the pushing member, the base is further fixedly connected with a pump assembly and a fixed arm, the top of the fixed arm is fixedly connected with a multi-modal integrated sensor, the side wall of the fixed arm is fixedly connected with a controller, and the robotic arm, the pushing member, the puncture needle, the pump assembly and the multi-modal integrated sensor are all signal-connected to the controller;

[0008] The robotic arm is used to control the three-dimensional needle insertion angle of the puncture needle as a whole and assist in compensating for the respiratory movement displacement; the pushing member is used to control the needle insertion and retraction of the puncture needle; the puncture needle is used to actively guide the puncture of the patient's organ to reach the lesion to perform sampling, inactivation, hemostasis and chemotherapy tasks and spray the hemostatic gel along the way according to the needle insertion situation; the pump assembly is used to provide negative pressure suction and storage space for lesion sampling and provide positive air pressure for spraying the hemostatic gel; the multi-modal integrated sensor is used to detect 3D organ ultrasound data through high-frequency ultrasound technology, track the position of the puncture needle head through electromagnetic positioning technology, and detect respiratory movement displacement data through surface inertial sensing technology and optical tracking technology; the controller is used to collect 3D organ segmentation data to construct a 3D organ segmentation model, combine electromagnetic positioning technology and fiber optic sensing technology to guide the orientation and needle insertion of the puncture needle, collect respiratory movement displacement data to construct an LSTM organ displacement prediction model, predict the respiratory movement displacement law and provide delay compensation, and control the robotic arm and the puncture needle to perform respiratory movement displacement compensation puncture sampling.

[0009] The principle of the basic solution is as follows: The robotic arm is responsible for controlling the three-dimensional needle insertion angle of the puncture needle as a whole and assisting in respiratory movement displacement compensation during the puncture process to ensure that the puncture needle can accurately reach the lesion location. The pusher is responsible for controlling the needle insertion and retraction actions of the puncture needle to achieve precise movement of the puncture needle within the patient's body. The puncture needle can not only actively guide the puncture of the patient's organ to reach the lesion and perform tasks such as sampling, inactivation, and chemotherapy, but also spray hemostatic gel along the way according to the needle insertion situation to reduce the bleeding risk during the puncture process. The pump assembly provides negative pressure suction for lesion sampling to suck the collected samples into the storage space; at the same time, it provides positive air pressure for spraying the hemostatic gel to ensure that the hemostatic gel can be accurately and evenly sprayed at the required position. The multi-modal integrated sensor uses ultrasonic technology to detect 3D organ ultrasonic data to obtain detailed structural information of the organ; it tracks the position of the puncture needle head through electromagnetic positioning technology to real-time master the position of the puncture needle in the body; it uses surface inertial sensing technology and optical tracking technology to detect respiratory movement displacement data to provide a basis for subsequent displacement compensation. The controller collects 3D organ segmentation data, constructs a 3D organ segmentation model, and combines electromagnetic positioning technology and fiber optic sensing technology to guide the orientation and needle insertion of the puncture needle to ensure that the puncture needle accurately reaches the lesion along the predetermined path. At the same time, it collects respiratory movement displacement data, constructs an LSTM organ displacement prediction model, predicts the law of respiratory movement displacement, and provides delay compensation to control the robotic arm and the puncture needle to perform respiratory movement displacement compensation puncture sampling, improving the accuracy and safety of the puncture.

[0010] The beneficial effects of the basic solution are as follows: 1. In traditional hepatobiliary and pancreatic puncture surgeries, it is often necessary to perform multiple punctures to separately complete different tasks such as sampling, inactivation, hemostasis, and chemotherapy. Each puncture requires repositioning, adjusting the puncture angle and depth, which not only consumes a large amount of time but also increases the risk and complexity of the surgery. However, the hepatobiliary and pancreatic clinical puncture sampling device of the present invention enables the puncture needle to achieve multiple functions simultaneously during a single puncture by integrating multiple functional layers. For example, when performing lesion sampling, the puncture needle can synchronously perform inactivation operations to directly process the lesion cells, avoiding the need for a second puncture for inactivation. During the puncture process, hemostatic gel can be sprayed in a timely manner as needed, eliminating the need for additional time for hemostasis treatment. This multi-functional integrated design greatly simplifies the surgical procedure, reduces unnecessary operating steps, thus significantly shortening the surgical time and improving the surgical efficiency.

[0011] 2. The device utilizes advanced sensor and controller technologies to enable precise control of the puncture needle. The multi-modal integrated sensors can acquire detailed structural information of the organ and the position of the puncture needle in real time. The controller accurately guides the orientation and insertion of the puncture needle based on this data. This allows the puncture needle to accurately reach the lesion location in one go, avoiding multiple puncture attempts caused by inaccurate positioning. Compared with the situation in traditional surgeries where repeated adjustments may be required due to puncture position deviation, this device greatly improves the success rate of puncture, reduces the time for repeated operations, and further enhances the surgical efficiency.

[0012] 3. During the puncture process, accidental puncture and fibrotic tissue are common causes of significant bleeding. In the device of the present invention, the sliding tube can adaptively control the spraying of the hemostatic gel according to the resistance it receives during needle insertion. When the puncture needle encounters fibrotic tissue or blood vessels and other sites prone to bleeding, the resistance received by the puncture needle will change, and the puncture needle adaptively adjusts the spraying amount and spraying position of the hemostatic gel according to this change. This adaptive control method can ensure that the hemostatic gel is accurately sprayed on the areas with a higher bleeding risk, quickly forming a hemostatic barrier and avoiding the occurrence of significant bleeding. Compared with traditional surgeries where doctors need to rely on experience to judge when to use hemostatic measures, this device is more scientific and precise, can effectively reduce the amount of bleeding, and reduce the harm caused to patients due to excessive bleeding.

[0013] 4. The multi-modal integrated sensor is one of the key components for improving the puncture accuracy of this device. It can detect 3D organ ultrasound data through high-frequency ultrasound technology, clearly showing the internal structure and morphology of the organ, and helping doctors understand the location of the lesion and the surrounding tissues. The electromagnetic positioning technology can real-time track the position of the puncture needle tip to ensure that the movement trajectory of the puncture needle in the body is controllable. The surface inertial sensing technology and optical tracking technology can detect respiratory movement displacement data, providing accurate information for subsequent displacement compensation. The controller fuses and processes these multi-modal data to construct a 3D organ segmentation model and an LSTM organ displacement prediction model. Through these models, the controller can accurately calculate the optimal insertion path of the puncture needle and real-time adjust the direction and depth of the puncture needle to guide the puncture needle to accurately reach the lesion location.

[0014] 5. Respiratory movement is one of the important factors leading to puncture position deviation. During hepatobiliary and pancreatic puncture surgeries, the patient's breathing causes organ displacement, thus affecting the accuracy of puncture. Under the command of the controller, the robotic arm of this device can perform real-time compensation based on respiratory movement displacement data. The controller predicts the displacement law of respiratory movement through the LSTM organ displacement prediction model and adjusts the actions of the robotic arm in advance, enabling the puncture needle to move synchronously with the displacement of the organ, ensuring that the puncture needle always aims at the lesion. This respiratory movement displacement compensation function greatly improves the accuracy of puncture and reduces the occurrence of puncture failures and complications caused by respiratory movement.

[0015] Furthermore, the puncture needle includes a syringe barrel. One end of the syringe barrel is connected to a needle tube. The other end of the syringe barrel is vertically and symmetrically fixedly connected with push pieces, and the push pieces are fixedly connected to a pushing member. The end of the needle tube far from the syringe barrel is fixedly connected with a needle tip. The needle tube includes a biopsy inner core tube, and a number of symmetric annular grooves are formed on the biopsy inner core tube. The annular grooves of different cross-sections are arranged in a spiral and staggered manner. An alloy tube is fixedly sleeved outside the biopsy inner core tube. A number of piezoelectric ceramic fibers are embedded in parallel in the inner circumference of the alloy tube. A drug slow-release layer, an insulating layer, and a radiofrequency electrode layer are sequentially fixedly sleeved outside the alloy tube. One ends of the alloy tube, the insulating layer, and the radiofrequency electrode layer are all fixedly connected to the syringe barrel. A number of through holes communicating with the drug slow-release layer are axially formed at the other ends of the insulating layer and the radiofrequency electrode layer. The biopsy inner core tube communicates with the needle tip. An electromagnetic positioning coil is fixedly sleeved on the outer circumference of the rear end of the needle tip. An optical fiber array and a gel tube are axially laid in the biopsy inner core tube. The piezoelectric ceramic fibers are all electrically connected to the controller, and the electromagnetic positioning coil is connected to a control signal.

[0016] The beneficial effects of the basic solution are as follows: 1. The spiral annular groove design endows the biopsy inner core tube with anisotropic mechanical properties, enhancing the lateral flexibility while maintaining the axial rigidity. Combined with the micro-displacement drive of piezoelectric ceramic fibers, active bending and path correction of the needle tip are achieved, effectively avoiding sensitive structures such as blood vessels and nerves. The electromagnetic positioning coil real-time feedbacks the spatial position of the needle tip. After being fused with the optical tracking data, it forms a sub-millimeter-level navigation accuracy, significantly reducing the puncture deviation.

[0017] 2. The radiofrequency electrode layer generates a controllable thermal field through high-frequency current to precisely inactivate the lesion tissue. At the same time, the thermal effect can enhance the permeability of the drug slow-release layer; the drug slow-release layer releases chemotherapy drugs based on the pH response of the tumor microenvironment, forming a "hyperthermia + chemotherapy" synergistic effect with radiofrequency ablation to improve the local treatment effect. The insulating layer isolates the radiofrequency current from the drug carrier, avoiding electrolytic reaction from interfering with the drug activity, and at the same time reducing the damage to surrounding healthy tissues caused by heat conduction.

[0018] 3. The integrated structure design integrates biopsy, ablation, drug delivery, and hemostasis functions into a single needle, avoiding tissue trauma caused by repeated punctures and shortening the operation time. pH-triggered drug release ensures continuous release of chemotherapy drugs in the acidic microenvironment of tumors, maintaining local effective concentration and reducing systemic toxic reactions; the necrotic tissue after radiofrequency ablation can act as a drug sustained-release carrier, prolonging the action time.

[0019] 4. The fiber optic array monitors the needle body strain in real time through the grating wavelength drift, dynamically identifies sudden changes in tissue resistance (such as accidental puncture of blood vessels), and triggers the adaptive release of hemostatic gel from the gel tube to form a double barrier of physical occlusion and biological coagulation. The superelastic alloy tube can still return to its initial shape after multiple bends, combined with the closed-loop control driven by piezoelectricity, avoiding the risk of needle body fracture caused by plastic deformation.

[0020] Furthermore, an inner sleeve is axially fixedly connected to the inner wall of the needle tip. A sliding tube is slidably fitted at the front end of the inner sleeve. The rear end of the sliding tube communicates with a first arc-shaped member. A first axial groove is formed on the side wall of the first arc-shaped member close to the radial center of the sliding tube. A sliding groove is formed on the side wall of the sliding tube away from the first arc-shaped member. An injection tube is fixedly connected to the rear end of the inner sleeve. The front end of the injection tube communicates with a second arc-shaped member. A second axial groove is formed on the side wall of the second arc-shaped member close to the radial center of the injection tube. A sliding rail is fixedly connected to one side of the front end of the second arc-shaped member. The sliding rail cooperates with the sliding groove. A return spring is fixedly connected to the front end of the second arc-shaped member. The other end of the return spring is fixedly connected to the first arc-shaped member. The first arc-shaped member and the second arc-shaped member are slidably fitted with each other. The first axial groove and the second axial groove are slidably fitted coaxially with each other. The injection tube communicates with the gel tube.

[0021] The beneficial effect of the basic solution is that when the needle tip encounters blood vessels or fibrotic tissues, the resistance triggers the axial retraction of the sliding tube along the sliding rail. The axial grooves of the first arc-shaped member and the second arc-shaped member are accurately aligned to form a gel injection channel, ensuring that the hemostatic substance reaches the damaged site directly. The greater the resistance, the greater the retraction of the sliding tube, and the larger the channel formed by the axial grooves, adaptively spraying hemostatic gel during the penetration process of normal tissues and fibrotic tissues. After release, the spring automatically resets to close the channel, avoiding gel leakage or excessive release, while maintaining the compactness of the needle tip structure and reducing the risk of secondary tissue damage.

[0022] Furthermore, the alloy tube is made of superelastic nickel-titanium alloy material; the drug sustained-release layer is made of nanoporous material, and the front end of the drug sustained-release layer is sealed with an environmental pH value-responsive group; annular electrodes are symmetrically laid on the outer side wall of the front end of the radiofrequency electrode layer, and a reference electrode is laid on the outer side wall of the rear end of the radiofrequency electrode layer.

[0023] The beneficial effects of the basic solution are as follows: 1. The superelastic nickel-titanium alloy tube endows the puncture needle with excellent shape recovery ability, and it can still maintain structural integrity after being bent multiple times in complex anatomical paths, avoiding the fracture risk caused by traditional metal fatigue. At the same time, its low stiffness characteristic reduces the penetration damage to fragile tissues (such as liver cirrhosis areas) to a certain extent.

[0024] 2. The nano-porous structure screens drug molecules through the size effect to achieve the balance of high drug loading capacity and controllable release rate; the pH-responsive group dissociates specifically in the acidic microenvironment of tumors, releasing chemotherapy drugs to the core of the lesion directionally and reducing systemic toxicity; the porous framework synchronously adsorbs tissue exudate, maintains the local drug concentration gradient, and extends the treatment window.

[0025] 3. The compact spacing of the front-end annular electrodes forms a high-intensity focused electric field, improving the ablation efficiency. At the same time, it limits the range of heat diffusion, protecting adjacent important structures; the remote design of the rear-end reference electrode reduces the impedance of the current loop, ensuring the uniformity of the temperature distribution in the ablation area and avoiding the phenomena of edge carbonization or central overheating; the synergistic effect of the electrode layer and the insulating layer precisely confines the radiofrequency energy to the target area, reducing the thermal interference to the drug slow-release layer.

[0026] Furthermore, the multi-modal integrated sensor includes an ultrasonic probe. The ultrasonic probe is fixedly connected to the top of the fixed arm. The ultrasonic probe is used to detect the 3D organ ultrasonic data around the lesion, and the ultrasonic probe is signal-connected to the controller.

[0027] The beneficial effects of the basic solution are as follows: 1. High-frequency ultrasound penetrates the tissues around the lesion, generating three-dimensional images with millimeter-level resolution, dynamically presenting key structures such as the vascular trajectory and bile duct distribution, assisting the operator to identify and avoid risk areas in real time during the needle insertion process, and reducing the probability of accidentally injuring sensitive tissues.

[0028] 2. The ultrasonic image is registered with the electromagnetic positioning and fiber optic sensing data in real time to construct a high-precision spatial mapping field, eliminating the perception blind spots of a single modality (such as the sensitivity limitation of ultrasound to deep small lesions), forming a "global-local" collaborative navigation system, and ensuring the anatomical adaptability of the puncture path.

[0029] Furthermore, the multi-modal integrated sensor also includes an optical tracker and several inertial sensors. The optical tracker is fixedly connected to the top of the fixed arm. The reflective markers and inertial sensors equipped with the optical tracker are both fixed on the skin surface of the patient's chest and abdomen. The optical tracker and the inertial sensors are both signal-connected to the controller.

[0030] The beneficial effects of the basic solution are: 1. The optical tracker captures the macroscopic displacement of the instrument end in real time, while the inertial sensor intensively monitors the microscopic deformation of the patient's body surface. When the patient has respiratory movement or fine-tuning of body position, the dual data fusion can accurately calculate the dynamic offset of the organ relative to the puncture needle, so that the controller can drive the robotic arm to make millimeter-level compensation adjustments.

[0031] 2. When relying solely on ultrasound or electromagnetic positioning, deep tissue displacement or tiny deformation is easily overlooked. However, the dense array of surface inertial sensors (2cm spacing is consistent with human anatomical characteristics) can capture the displacement of organs caused by diaphragm movement, etc., and cooperate with the global positioning of optical tracking to form a "surface-to-body" motion mapping chain.

[0032] 3. In surgeries on organs such as the liver, gallbladder and pancreas that move significantly with breathing, the system can dynamically update the puncture path. For example, when the patient's breathing cycle changes, the LSTM model predicts the organ's movement trajectory based on the time series data of the inertial sensor, and the robotic arm synchronously adjusts the needle insertion angle to keep the puncture needle in the safe puncture corridor.

[0033] Furthermore, the pump assembly includes a negative pressure pump and a positive pressure pump. The output end of the negative pressure pump is connected to a sampling tube, and the input end of the positive pressure pump is connected to a gel tank, which is filled with a temperature-sensitive hemostatic gel. The input end of the negative pressure pump is connected to a suction tube, which extends upward through the syringe and is connected to the biopsy core tube. The output end of the positive pressure pump is connected to a supply tube, which extends upward through the syringe and the needle tube and is connected to the injection tube. Both the negative pressure pump and the positive pressure pump are connected to the controller signal.

[0034] The beneficial effect of the basic solution is that the pump assembly realizes the intelligent switching of sampling and hemostasis functions through the dual pump collaborative design of negative pressure pump and positive pressure pump. The negative pressure pump is directly connected to the biopsy core tube. After the puncture is in place, the controller can accurately adjust the negative pressure intensity to form a directional sampling flow. Its pulse suction technology can avoid tissue traction damage and is particularly suitable for fragile pancreatic tissue. The positive pressure pump forms a pressure delivery system with the gel tank. The temperature-sensitive hemostatic gel reaches the needle tip directly through the supply tube and spreads rapidly at 37°C. This gel quickly forms a physical barrier when it encounters blood, and its temperature-sensitive properties ensure rapid solidification at body temperature without blocking the pipeline during delivery.

[0035] Furthermore, the pusher includes a pusher motor. Parallel sliding grooves are formed at the bottom of the guide rail. The inner top wall of the sliding groove is fixedly connected to the pusher motor. The output end of the pusher motor is coaxially and fixedly connected with a motor gear. A toothed belt is engaged with the motor gear. The inner top wall of the sliding groove is fixedly connected with a snap ring. A lead screw nut is slidably connected inside the snap ring. A pusher lead screw is in threaded fit inside the lead screw nut. One end of the pusher lead screw away from the needle tip is fixedly connected with a pusher block. A card slot for cooperating with the pusher piece is formed on the top wall of the pusher block. One side of the pusher block close to the guide rail is fixedly connected with a sliding piece. A strip-shaped groove is formed on the guide rail. The sliding piece is slidably engaged with the strip-shaped groove. The pusher electrode is in signal connection with the controller.

[0036] The beneficial effects of the basic solution are as follows: 1. The pusher adopts a mechatronic design. Its core is that the pusher motor converts rotational motion into linear motion of the pusher block through gear and toothed belt transmission. The sliding groove at the bottom of the guide rail serves as a motion guiding track to ensure the precise displacement of the pusher block along a predetermined path. The meshing design of the motor gear and the toothed belt realizes high-torque transmission while maintaining low-noise characteristics, which is particularly suitable for puncture scenarios requiring fine control.

[0037] 2. The pusher block realizes micro-displacement control through a lead screw nut mechanism. The pusher lead screw inside it adopts a variable lead design, enabling the puncture needle to quickly enter the needle in the initial stage and automatically switch to a precision stepping mode (the minimum stepping amount can reach 0.05 mm) when approaching the lesion. This dual-mode control not only ensures the puncture efficiency but also avoids tissue tearing caused by excessive needle insertion.

[0038] Furthermore, a high-frequency generator and a fiber optic strain sensor are provided inside the controller. The high-frequency generator is connected with a plurality of cables. The cables extend upward through the syringe barrel and are fixedly connected with the annular electrode and the reference electrode. The fiber optic array passes through the sampling tube wall and the syringe barrel along the inner wall of the needle tube and is fixedly connected with the fiber optic strain sensor.

[0039] The beneficial effects of the basic solution are as follows: 1. By integrating the high-frequency generator and the fiber optic strain sensor, the controller realizes closed-loop control of energy output and state monitoring. The high-frequency generator delivers precisely regulated radiofrequency energy to the annular electrode at the front end of the puncture needle through the cables, forming a controllable thermal field in the target area. Its dynamic power adjustment technology can adjust the output parameters in real time according to tissue impedance to ensure that the temperature in the ablation area is stable within the optimal treatment window of 60 - 80 °C, inactivating the lesion while avoiding carbonization.

[0040] 2. The fiber optic strain sensor, through the fiber optic array deployed along the inner wall of the needle tube, real-time monitors the micro-deformation of the puncture needle in a complex anatomical path. When the needle body encounters hardened tissue or tumor nodules, the wavelength drift of the fiber grating will be immediately fed back to the controller, and the system can synchronously adjust the needle insertion speed and radiofrequency ablation power. This real-time strain monitoring enables doctors to anticipate changes in tissue resistance, optimize the puncture strategy in advance, and effectively avoid important structures such as blood vessels and nerves.

[0041] Furthermore, the controller is also provided with a data acquisition module, a model construction module, a prediction module, a guidance module, a respiratory motion compensation module, and an execution module;

[0042] The data acquisition module is used to acquire 3D organ ultrasound data, inertial sensing data, optical tracking data, electromagnetic positioning data, fiber optic strain curvature data, and puncture tissue impedance data;

[0043] The model construction module is used to construct a 3D organ segmentation model based on the 3D organ ultrasound data, identify the target organ and main blood vessels, and use the Monte Carlo obstacle avoidance algorithm to plan the needle insertion path;

[0044] The prediction module is used to establish and correct a respiratory phase-organ displacement prediction model using the LSTM neural network combined with the viscoelastic biomechanical model based on the three-dimensional acceleration data and angular velocity data in the inertial sensing data and the optical tracking data. The phase division in the model discretizes the respiratory cycle into 0° - 360°, where the inhalation phase is 0° - 180°, and the exhalation phase is 180° - 360°. The real-time phase angle calculation formula is as follows:

[0045]

[0046] In the formula, is the volume change rate, V max is the maximum volume change amount of the respiratory cycle,

[0047] The phase feature extraction is to calculate the instantaneous volume to extract the thoracic volume change rate through the three-dimensional coordinates of the marked points of the optical tracker, and to extract the diaphragm movement speed through the differential of the vertical displacement of the marked point cluster of the inertial sensor;

[0048] The guidance module is used to reconstruct the electromagnetic positioning data and fiber optic strain curvature data into the 3D organ segmentation model in real time for real-time needle insertion guidance. The real-time reconstruction formula of the three-dimensional curvature is as follows:

[0049]

[0050] In the formula, h = 0.4mm,

[0051] Control the robotic arm and the driving motor to point the puncture needle at the target lesion and avoid blood vessels and other organs;

[0052] The respiratory motion compensation module is used for the time series prediction based on the LSTM neural network, to output the organ displacement prediction queue in advance, and to control the robotic arm to drive the puncture needle to translate following the respiratory cycle, synchronously realizing respiratory motion compensation and delay compensation;

[0053] An execution module, which is used to control a negative pressure pump to aspirate samples after the puncture needle reaches the lesion, control a positive pressure pump to supply hemostatic gel, control the high-frequency generation inactivation of the annular electrode, and adjust the power of the annular electrode according to the puncture tissue impedance data, so as to realize the integrated functions of sampling, inactivation, hemostasis and chemotherapy.

[0054] The beneficial effects of the basic scheme are as follows: 1. The acquisition module integrates multi-source data such as ultrasonic images, electromagnetic positioning, and inertial sensing in real time to form a holographic surgical field of "anatomical structure + instrument position + physiological movement". The model construction module is based on the Monte Carlo algorithm, and performs million-level path simulations in the 3D organ model to quickly screen out a puncture scheme that can avoid major blood vessels (the obstacle avoidance success rate is increased to 97.6%) and ensure the shortest path (the path optimization efficiency is increased by 42%).

[0055] 2. The prediction module innovatively combines the LSTM neural network with the viscoelastic biomechanical model, and through the double verification of the diaphragm movement speed and the thoracic cavity volume change rate, realizes the accurate division of the respiratory phase. Its phase angle calculation formula can capture the respiratory rhythm changes in real time, so that the prediction error of the respiratory motion compensation module is controlled within 0.8 mm. The robotic arm starts the compensation action 0.3 - 0.5 seconds in advance according to the prediction model, effectively offsetting the organ displacement caused by the respiratory motion.

[0056] 3. The guiding module adopts the differential curvature reconstruction algorithm to calculate the three-dimensional shape of the needle body in real time through the fiber optic strain data. The sampling interval of 0.4 mm ensures the real-time prediction of the tip position. Combined with the millimeter-level accuracy of electromagnetic positioning, the puncture needle can dynamically adjust the path, avoiding nerve blood vessels while maintaining the targeting accuracy.

[0057] 4. The execution module realizes the intelligent linkage of "sampling - inactivation - hemostasis - chemotherapy". The negative pressure pump accurately obtains the lesion tissue through pulsed suction, the positive pressure pump automatically adjusts the gel spraying amount according to the puncture resistance, and the high-frequency generator adjusts the radio frequency power in real time according to the tissue impedance, forming a synergistic treatment system of "mechanical energy - thermal energy - chemical energy". This intelligent regulation not only shortens the operation time by 40%, but also greatly reduces the complication rate. Description of the Drawings

[0058] Figure 1 It is an axonometric view of the clinical puncture sampling device for hepatobiliary and pancreatic in the embodiment of the present invention.

[0059] Figure 2 It is a side view of the clinical puncture sampling device for hepatobiliary and pancreatic in the embodiment of the present invention.

[0060] Figure 3 It is a top-down sectional view of the pusher in the embodiment of the present invention.

[0061] Figure 4 It is a top-down sectional view of the puncture needle in the embodiment of the present invention.

[0062] Figure 5 The enlarged view of position A in Figure 1 .

[0063] Figure 6 The enlarged view of position B in Figure 4 .

[0064] Figure 7 The enlarged view of position C in Figure 4 .

[0065] Figure 8 The operation schematic diagram of the controller of the hepatobiliary and pancreatic clinical puncture sampling device in the embodiment of the present invention.

[0066] The reference numerals in the accompanying drawings of the specification include: 1, base; 2, fixed arm; 3, sampling tube; 4, negative pressure pump; 5, suction tube; 6, gel tank; 7, positive pressure pump; 8, supply tube; 9, cable; 10, fiber optic array; 11, robotic arm; 12, push block; 13, push piece; 14, sliding piece; 15, syringe; 16, guide rail; 17, needle tube; 18, optical tracker; 19, controller; 20, high frequency generator; 21, fiber optic strain sensor; 22, needle tip; 23, ultrasonic probe; 24, push screw rod; 25, toothed belt; 26, push motor; 27, screw nut; 28, annular electrode; 29, sliding tube; 30, biopsy inner core tube; 31, first arc-shaped member; 32, first axial groove; 33, return spring; 34, second axial groove; 35, second arc-shaped member; 36, injection tube; 37, inner sleeve; 38, annular groove; 39, piezoelectric ceramic fiber; 40, drug slow release layer; 41, insulating layer; 42, radio frequency electrode layer; 43, environmental pH value responsive group; 44, through hole; 45, superelastic alloy tube; 46, electromagnetic positioning coil. Specific Embodiments

[0067] The following is a further detailed description through specific embodiments:

[0068] Embodiment 1

[0069] Basically as shown in the attached Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 and Figure 8As shown: A clinical puncture sampling device for hepatobiliary and pancreatic diseases, including a base 1, on which a robotic arm is welded. At the top of the robotic arm, a puncture needle is installed. At the top of the robotic arm, a guide rail 16 for installing the puncture needle is welded. A pusher is slidably fitted on the side of the guide rail 16 away from the head of the puncture needle. The puncture needle is welded to the pusher. A pump assembly and a fixed arm 2 are also welded on the base 1. At the top of the fixed arm 2, a multi-modal integrated sensor is welded. On the side wall of the fixed arm 2, a controller 19 is adhesively attached. The robotic arm, the pusher, the puncture needle, the pump assembly, and the multi-modal integrated sensor are all signal-connected to the controller 19.

[0070] The robotic arm is used to control the three-dimensional needle insertion angle of the puncture needle as a whole and assist in compensating for the displacement during respiratory movement; the pusher is used to control the insertion and withdrawal of the puncture needle; the puncture needle is used to actively guide the puncture of the patient's organ to reach the lesion to perform sampling, inactivation, hemostasis, and chemotherapy tasks and spray hemostatic gel along the way according to the needle insertion situation; the pump assembly is used to provide negative pressure suction and storage space for lesion sampling and positive air pressure for spraying hemostatic gel; the multi-modal integrated sensor is used to detect 3D organ ultrasound data through ultrasonic technology, track the position of the head of the puncture needle through electromagnetic positioning technology, and detect respiratory movement displacement data through surface inertial sensing technology and optical tracking technology; the controller 19 is used to collect 3D organ segmentation data to construct a 3D organ segmentation model, combine electromagnetic positioning technology and fiber optic sensing technology to guide the orientation and insertion of the puncture needle, collect respiratory movement displacement data to construct an LSTM organ displacement prediction model, predict the law of respiratory movement displacement and provide delay compensation, and control the robotic arm and the puncture needle to perform respiratory movement displacement compensation puncture sampling.

[0071] Such as Figure 6As shown, the puncture needle includes a syringe barrel 15. One end of the syringe barrel 15 is connected to a needle tube 17. At the other end of the syringe barrel 15, push pieces 13 are perpendicularly and symmetrically welded. The push pieces 13 are all clamped with a pushing member. At the end of the needle tube 17 far from the syringe barrel 15, a needle tip 22 is welded. The needle tube 17 includes a biopsy inner core tube 30. A number of symmetric annular grooves 38 are formed on the biopsy inner core tube 30. The depth of each annular groove 38 is 0.1 mm. The annular grooves 38 in different cross-sections are arranged in a spiral and staggered manner. An alloy tube 45 is fixedly sleeved outside the biopsy inner core tube 30. A number of piezoelectric ceramic fibers 39 are embedded in parallel in the circumferential direction inside the superelastic alloy tube 45. A drug slow-release layer 40, an insulating layer 41, and a radiofrequency electrode layer 42 are adhesively bonded in sequence outside the alloy tube 45. One ends of the alloy tube 45, the insulating layer 41, and the radiofrequency electrode layer 42 are all adhesively bonded to the syringe barrel 15. A number of through holes 44 communicating with the drug slow-release layer 40 are axially formed at the other ends of the insulating layer 41 and the radiofrequency electrode layer 42. The biopsy inner core tube 30 communicates with the needle tip 22. An electromagnetic positioning coil 46 is fixedly sleeved on the outer periphery of the tail of the needle tip 22. The drug slow-release layer 40 is used to slowly release chemotherapy drugs in a pH value-triggered manner in the environment. The insulating layer 41 is used to separate the radiofrequency electrode layer 42 from the drug slow-release layer 40 to reduce the influence of the current and high temperature generated by radiofrequency ablation. The radiofrequency electrode layer 42 is used to inactivate the biological tissue near the needle tip 22 through the ionization effect generated by high-frequency current. An optical fiber array 10 and a gel tube are axially laid in the biopsy inner core tube 30. The optical fiber array 10 includes 4 optical fibers. Three gratings are arranged in each optical fiber. The piezoelectric ceramic fibers 39 are all electrically connected to a controller 19. The electromagnetic positioning coil 46 is connected to a control signal.

[0072] An inner sleeve 37 is axially welded to the inner wall of the needle tip 22. A sliding tube 29 is slidably fitted at the front end of the inner sleeve 37. A first arc-shaped member 31 is connected to the rear end of the sliding tube 29. A first axial groove 32 is formed on the side wall of the first arc-shaped member 31 close to the radial center of the sliding tube 29. A sliding groove is formed on the side wall of the sliding tube 29 far from the first arc-shaped member 31. An injection tube 36 is adhesively bonded to the rear end of the inner sleeve 37. A second arc-shaped member 35 is connected to the front end of the injection tube 36. A second axial groove 34 is formed on the side wall of the second arc-shaped member 35 close to the radial center of the injection tube 36. A sliding rail is welded to one side of the front end of the second arc-shaped member 35. The sliding rail is matched with the sliding groove. A return spring 33 is welded to the front end of the second arc-shaped member 35. The other end of the return spring 33 is welded to the first arc-shaped member 31. The first arc-shaped member 31 and the second arc-shaped member 35 are slidably matched with each other. The first axial groove 32 and the second axial groove 34 are slidably matched coaxially with each other. The injection tube 36 communicates with the gel tube.

[0073] The alloy tube 45 is made of a superelastic nickel-titanium alloy material; the drug slow-release layer 40 is made of a nanoporous material with a pore diameter of 50 - 200 nm and a porosity of 65% - 70%. The front end of the drug slow-release layer 40 is closed with an environmental pH value-responsive group 43; on the outer side wall of the front end of the radiofrequency electrode layer 42, annular electrodes 28 are symmetrically laid with a spacing of 1.5 - 2 mm. On the outer side wall of the rear end of the radiofrequency electrode layer 42, a reference electrode is laid, and the reference electrode is 20 - 22 mm away from the needle tip 22.

[0074] The multimodal integrated sensor includes an ultrasonic probe 23, which is welded to the top of the fixed arm 2. The ultrasonic probe 23 is used to detect the 3D organ ultrasonic data around the lesion, and the ultrasonic probe 23 is signal-connected to the controller 19. The multimodal integrated sensor also includes an optical tracker 18 and several inertial sensors. The optical tracker 18 is welded to the top of the fixed arm 2. The reflective markers and inertial sensors equipped with the optical tracker 18 are all pasted on the skin surface of the patient's chest and abdomen. The spacing between the inertial sensors is 2 cm. The optical tracker 18 and the inertial sensors are both signal-connected to the controller 19.

[0075] The pump assembly includes a negative pressure pump 4 and a positive pressure pump 7. The output end of the negative pressure pump 4 is connected to a sampling tube 3. The input end of the positive pressure pump 7 is connected to a gel tank 6, and the gel tank 6 is filled with a temperature-sensitive hemostatic gel. The input end of the negative pressure pump 4 is connected to a suction tube 5, and the suction tube 5 extends upward through the syringe barrel 15 and is connected to the biopsy inner core tube 30. The output end of the positive pressure pump 7 is connected to a supply tube 8, and the supply tube 8 extends upward through the syringe barrel 15 and the needle tube 17 and is connected to an injection tube 36. The negative pressure pump 4 and the positive pressure pump 7 are both signal-connected to the controller 19.

[0076] The pusher includes a pusher motor 26. Parallel chutes are opened at the bottom of the guide rail 16. The inner top wall of the chute is fixedly connected to the pusher motor 26. The output end of the pusher motor 26 is coaxially welded with a motor gear, and a toothed belt 25 is engaged with the motor gear. The inner top wall of the chute is welded with a snap ring, and a lead screw nut 27 is slidably connected inside the snap ring. A pusher lead screw 24 is in threaded cooperation inside the lead screw nut 27. One end of the pusher lead screw 24 away from the needle tip 22 is welded with a pusher block 12. A slot for cooperating with the pusher piece 13 is opened on the top wall of the pusher block 12. On one side of the pusher block 12 close to the guide rail 16, a sliding piece 14 is welded. A blade-shaped groove is opened on the guide rail 16, and the sliding piece 14 is slidably matched with the blade-shaped groove. The pusher electrode is signal-connected to the controller 19.

[0077] A high-frequency generator 20 and a fiber optic strain sensor 21 are installed inside the controller 19. The high-frequency generator 20 is connected to several cables 9, and the cables 9 extend upward through the syringe barrel 15 and are welded to the annular electrodes 28 and the reference electrode. The fiber optic array 10 passes through the wall of the sampling tube 3 and the syringe barrel 15 along the inner wall of the needle tube 17 and is bonded to the fiber optic strain sensor 21.

[0078] The specific implementation process is as follows: Traditional clinical puncture sampling of the hepatobiliary and pancreas often relies on doctors holding biopsy needles. While observing the lesion location on the screen of the ultrasonic monitor, they manually insert the needle and adjust the needle insertion direction. After reaching the lesion, they also need to manually control the start and speed of the sampling operation, which undoubtedly affects the efficiency of the sampling operation and increases the uncertainty of accidents during the sampling operation. Even for automatic needle insertion devices, they are merely simple stable propulsion devices combined with robotic arms with multiple degrees of freedom. Although they can replace manual work to a certain extent through programming and information collection, they cannot compensate for the respiratory displacement of the patient's organs physiologically, and problems such as needle insertion deviation and tissue tearing may occur.

[0079] Based on these problems above, the present invention first detects the 3D organ ultrasonic data of the patient through the ultrasonic probe 23 on the fixed arm 2. These data include organ type, organ contour, the distribution of various tissues inside the organ, and the blood vessel distribution inside the organ, etc. Then the controller 19 establishes a 3D organ segmentation model as the "map" for subsequent needle insertion. On this basis, the optical tracker 18 and the inertial sensor can also collect the motion data of the patient's chest and abdomen driven by the diaphragm during the respiratory cycle, including the volume change rate and the motion speed. By using a neural network to establish a prediction model, it is possible to calculate and predict the respiratory movement of the patient's organs in advance, providing respiratory movement compensation and delay compensation for subsequent automatic needle insertion. Since the physical conditions of each patient are different, all the above data need to be collected again before each puncture operation, so as to perform precise puncture operations according to the personalized model.

[0080] Under the control of the controller 19 according to the 3D organ segmentation model and the respiratory movement compensation data, the robotic arm lifts and rotates the guide rail 16 to prepare for needle insertion. The robotic arm with multiple degrees of freedom allows the guide rail 16 to rotate and translate in at least four axes in three-dimensional space, so as to flexibly help the puncture needle adjust the puncture angle to compensate for the respiratory movement. The syringe barrel 15 of the puncture needle is installed in the guide rail 16, and the push piece 13 is fixed in the card slot, so that the advance and retreat of the puncture needle can be flexibly driven. When starting to insert the needle, the driving motor 26 rotates forward to drive the lead screw nut 27 in the snap ring to rotate through the toothed belt 25. The rotation of the lead screw nut 27 converts the radial rotation into the axial movement of the push lead screw 24. Since one end of the push lead screw 24 is fixedly connected to the push block 12, the push lead screw 24 can only move axially stably in the lead screw nut 27. The sliding piece 14 on the push block 12 further stabilizes the running track of the push block 12, so that the whole pushing part can accurately and stably adjust the puncture process.

[0081] After the puncture needle enters the patient's organ, how to accurately reach the lesion under respiratory motion compensation is another key issue in automated puncture. On the one hand, it is necessary to avoid the deviation of the needle insertion trajectory and tissue tearing under the respiratory displacement of the organ. On the other hand, important blood vessels and tissue areas should be avoided to prevent more serious problems. The controller 19 detects the three-dimensional position of the tip 22 of the puncture needle in the patient's body through the electromagnetic positioning coil 46 installed on the puncture needle, and can detect the curvature change of the puncture needle through the fiber optic array 10 on the inner wall of the puncture needle. These detected data can be substituted into the 3D organ segmentation model to construct the position function of the puncture needle, so as to reflect the trajectory and shape of the puncture needle in the patient's body in real time, providing a reference for the next needle insertion or withdrawal strategy. And during the needle insertion process, although the diameter of the puncture needle does not exceed 2.5 mm, tissue bleeding may still occur during puncture. Especially when puncturing fibrotic tissue, due to its high hardness, the puncture needle may tear these tissues and cause bleeding. The tip 22 of the puncture needle of this device divides the internal axial space of the puncture needle through the inner sleeve 37. During puncture, the resistance received by the tip 22 will push the sliding tube 29 back to compress the return spring 33, making the first arc-shaped part 31 and the second arc-shaped part 35 approach each other, so that the two axial grooves gradually cooperate to expand the delivery channel of the hemostatic gel. The change in this delivery volume is determined by the resistance received by the tip 22. Therefore, when puncturing normal tissue, a small amount of hemostatic gel is pushed by the positive pressure pump 7 to flow through the injection tube 36 and the axial groove to the sliding tube 29. When the tip resistance increases, such as when encountering fibrotic tissue with high hardness or reaching the lesion mass, at this time, the axial grooves cooperate with each other to enhance the delivery effect. On the one hand, it prevents bleeding after the fibrous tissue is torn, and on the other hand, it prepares in advance for the ablation bleeding of the subsequent lesion, reducing the mass or infection caused by bleeding. The temperature-sensitive hemostatic gel can spread well at body temperature or the high temperature caused by tissue ablation, thus enhancing the hemostatic range and effect.

[0082] Such as Figure 6As shown, existing puncture needles generally can only perform one function, similar to an ordinary needle for sucking tissue or tissue fluid from the lesion. Once the patient's lesion condition is severe and other treatment methods need to be implemented as soon as possible, only repeated punctures can be used to help other instruments reach the lesion for treatment, which will undoubtedly increase the risk of the patient's surgical treatment and cause pain to the patient. This device not only integrates the above-mentioned treatment instruments on the needle tube 17, but also can improve the flexibility of needle insertion by driving the bending of the needle tube 17 through piezoelectricity. The annular groove 38 opened on the outer wall of the biopsy inner core tube 30 of the needle tube 17 can endow the biopsy inner core tube 30 with the function of bending while only reducing the rigid strength of the biopsy inner core tube 30 by 30%. When bending, the axial arms of the annular groove 38 approach each other to achieve multi-directional bending. The piezoelectric ceramic fiber 39 in the alloy tube 45 can, under the control of the electrical signal of the controller 19, bend the biopsy inner core tube 30 by pushing and pulling when needed. The alloy tube 45 is mainly made of nickel-titanium alloy, which buffers the driving impact without affecting the deformation of the piezoelectric ceramic fiber 39 through its superelasticity and extends the service life.

[0083] When the puncture needle finally reaches the lesion, first, the needle tip 22 pierces into the lesion. The sliding tube 29 releases a large amount of hemostatic gel due to the change in the resistance of the lesion to the needle tip 22. The negative pressure pump 4 starts to suck the lesion tissue sample through the needle tip 22 and the biopsy inner core tube 30 and enters the sampling tube 3 through the suction tube 5. At the same time, the environmental pH-responsive group 43 at the front end of the drug slow-release layer 40 is affected by the low pH value of the lesion inflammation or cancer environment and undergoes conformational changes or detachment (such as poly-L-glutamic acid), enabling the therapeutic drug sealed in the nanoporous material to enter the lesion through the through-hole 44 for targeted treatment.

[0084] After sampling, if subsequent treatment is still required, first, the high-frequency generator 20 controls the generation of high-frequency current between the annular electrodes 28 on the outermost radiofrequency electrode layer 42 of the needle tube 17 through the cable 9, thereby inactivating the lesion cells through ionization and high-temperature physical ablation. The remaining high temperature after inactivation can promote the diffusion of the hemostatic gel released in large quantities, thereby enhancing its subsequent hemostatic effect. Part of these high temperatures will be absorbed by the drug slow-release layer 40 to reduce the damage of the high temperature to the surrounding normal tissues, and the absorbed heat will also promote the release speed and diffusion speed of the therapeutic drug, promoting the progress and effect of the overall treatment process. It not only realizes the multi-functional integration of sampling-inactivation-hemostasis-chemotherapy, reduces the number of punctures and the accident rate of treatment, but also enables the mutual promotion between the treatment processes, adaptively delivers the hemostatic gel, accelerates the healing of the puncture wound, avoids the bleeding injury that may be caused during the treatment process, and realizes the functions of automatic, precise and efficient puncture and treatment.

[0085] Example 2

[0086] The difference from the above embodiment is that as shown in the attached Figure 1 , Figure 2 andFigure 8 As shown: The controller 19 is also provided with a collection module, a model construction module, a prediction module, a guidance module, a respiratory motion compensation module, and an execution module;

[0087] The collection module is used to collect 3D organ ultrasound data, inertial sensing data, optical tracking data, electromagnetic positioning data, fiber optic strain curvature data, and puncture tissue impedance data;

[0088] The model construction module is used to construct a 3D organ segmentation model based on the 3D organ ultrasound data, identify the target organ and the main blood vessels, and plan the needle insertion path using the Monte Carlo obstacle avoidance algorithm;

[0089] The prediction module is used to establish and correct the respiratory phase-organ displacement prediction model using the LSTM neural network combined with the viscoelastic biomechanical model according to the three-dimensional acceleration data and angular velocity data in the inertial sensing data and the optical tracking data. The phase division in the model discretizes the respiratory cycle into 0° - 360°, where the inhalation phase is 0° - 180°, and the exhalation phase is 180° - 360°. The real-time phase angle calculation formula is as follows:

[0090]

[0091] In the formula, is the instantaneous volume change rate, V max is the maximum volume change amount of the respiratory cycle,

[0092] The phase feature extraction is to calculate the instantaneous volume to extract the thoracic volume change rate through the three-dimensional coordinates of the marker points of the optical tracker, and to extract the diaphragm movement speed through the differential of the vertical displacement of the marker point cluster of the inertial sensor;

[0093] The guidance module is used to reconstruct the electromagnetic positioning data and the fiber optic strain curvature data into the 3D organ segmentation model in real time for real-time needle insertion guidance. The real-time reconstruction formula of the three-dimensional curvature is as follows:

[0094]

[0095] In the formula, h = 0.4mm,

[0096] Control the robotic arm and the driving motor 26 to point the puncture needle at the target lesion and avoid blood vessels and other organs;

[0097] The respiratory motion compensation module is used for the time series prediction based on the LSTM neural network, to output the organ displacement prediction queue in advance, and to control the robotic arm to drive the puncture needle to translate along with the respiratory cycle, synchronously realizing respiratory motion compensation and delay compensation;

[0098] The execution module is used to control the negative pressure pump 4 to aspirate samples after the puncture needle reaches the lesion, control the positive pressure pump 7 to supply hemostatic gel, control the high-frequency generation inactivation of the annular electrode 28 and adjust the power of the annular electrode 28 according to the puncture tissue impedance data, so as to realize the integrated functions of sampling, inactivation, hemostasis and chemotherapy.

[0099] The specific implementation process is as follows: Similar to the process of Embodiment 1, the controller 19 mainly collects data from different sensors, performs modeling and operation simulation, then identifies the location of the lesion, controls the robotic arm and the puncture needle to guide to the lesion and moves cyclically to compensate for the organ respiratory displacement, so as to improve the accuracy of puncture sampling and treatment.

[0100] After the data is collected, first, the model construction module constructs a 3D organ segmentation model. After identifying the location of the lesion, important tissues and blood vessels, the Monte Carlo obstacle avoidance algorithm is used to plan the needle insertion path. The path calculation formula is as follows:

[0101] Collision probability assessment:

[0102]

[0103] Path optimization objective:

[0104] min q (α·||q - q target || + β·P collision )

[0105] In the formula, Ⅱ(·) is the indicator function, which is 1 when there is a collision and 0 otherwise. Ω vessel is the blood vessel spatial domain, and q is the path node coordinate.

[0106] In the subsequent process of using the LSTM neural network to establish a respiration-organ displacement prediction model, the model state equation is as follows:

[0107]

[0108] The input features are:

[0109]

[0110] The output prediction formula is:

[0111] Δp t =W y ·h t +b y

[0112] In the formula, σ is the Sigmoid activation function, ⊙ is the Hadamard product, is the diaphragm movement speed, and Δp t is the predicted organ displacement vector.

[0113] Meanwhile, the formula for respiratory motion delay compensation control is as follows:

[0114] Prediction-execution delay compensation:

[0115]

[0116] Dynamic queue buffering:

[0117]

[0118] When the controller 19 controls the displacement and bending of the robotic arm and the piezoelectric ceramic fiber 39 to drive the puncture needle and guides it to the lesion location, the fiber optic array 10 calculates the bending of the needle tube 17 in real time through three-dimensional curvature reconstruction, integrates it with the electromagnetic positioning data of the puncture needle tip 22, and judges the position of the puncture needle to facilitate accurate needle insertion positioning.

[0119] In addition to the above formula, the strain calculation formula for the three-dimensional curvature real-time reconstruction formula is as follows:

[0120]

[0121] In the formula, Δλ B is the drift amount of the fiber Bragg grating wavelength, and p e is the photoelastic coefficient (≈0.22).

[0122] After model establishment and calculation, the execution module can control the puncture needle to accurately reach the organ lesion, and compensate for the organ respiratory motion displacement and signal delay during the entire puncture process by using the multi-angle rotation and displacement of the entire robotic arm, so that the puncture needle is in a relatively stable state of motion between the patient's body and the lesion, avoiding tearing of the punctured tissue, reducing the patient's pain, and controlling the radiofrequency electrode layer 42 on the needle tube 17 to assist subsequent physical and chemical treatments, improving the treatment efficiency and surgical speed, and avoiding unnecessary injuries caused by multiple punctures.

[0123] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "including", "comprising" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device.

[0124] The above are only embodiments of the present invention. Specific structures and common knowledge such as characteristics that are well-known in the art are not described in detail herein. Those of ordinary skill in the art know all the common general technical knowledge in the technical field to which the invention pertains before the filing date or the priority date, are able to know all the prior art in this field, and have the ability to apply conventional experimental means before this date. Those of ordinary skill in the art can, under the inspiration given in this application, combine their own abilities to improve and implement this solution. Some typical well-known structures or well-known methods should not become an obstacle for those of ordinary skill in the art to implement this application. It should be noted that for those skilled in the art, without departing from the structure of the present invention, several deformations and improvements can still be made, and these should also be regarded as the protection scope of the present invention, and these will not affect the implementation effect of the present invention and the practicality of the patent. The protection scope claimed in this application shall be subject to the content of its claims, and the specific implementation manners and the like described in the specification can be used to interpret the content of the claims.

Claims

1. A clinical puncture sampling device for hepatobiliary and pancreatic diseases, comprising a base (1), a robotic arm fixedly connected to the base (1), and a puncture needle provided at the top of the robotic arm, characterized in that: A guide rail (16) for installing a puncture needle is fixedly connected to the top end of the robotic arm. A pusher is slidably engaged with a side of the guide rail (16) away from the head of the puncture needle. The puncture needle is fixedly connected to the pusher. A pump assembly and a fixed arm (2) are also fixedly connected to the base (1). A multi-modal integrated sensor is fixedly connected to the top end of the fixed arm (2). A controller (19) is fixedly connected to the side wall of the fixed arm (2). The robotic arm, the pusher, the puncture needle, the pump assembly, and the multi-modal integrated sensor are all signal-connected to the controller (19); The robotic arm is used to control the three-dimensional needle insertion angle of the puncture needle as a whole and assist in respiratory movement displacement compensation; The pusher is used to control the insertion and retraction of the puncture needle; The puncture needle is used to actively guide the puncture of the patient's organ to reach the lesion to perform sampling, inactivation, hemostasis, and chemotherapy tasks and spray hemostatic gel along the way according to the needle insertion situation; The pump assembly is used to provide negative pressure suction and storage space for lesion sampling and provide positive air pressure for spraying hemostatic gel; The multi-modal integrated sensor is used to detect 3D organ ultrasound data through ultrasonic technology, track the position of the puncture needle head through electromagnetic positioning technology, and detect respiratory movement displacement data through surface inertial sensing technology and optical tracking technology; The controller (19) is used to collect 3D organ segmentation data to construct a 3D organ segmentation model, combine electromagnetic positioning technology and fiber optic sensing technology to guide the orientation and insertion of the puncture needle, collect respiratory movement displacement data to construct an LSTM organ displacement prediction model, predict the law of respiratory movement displacement and provide delay compensation, and control the robotic arm and the puncture needle to perform respiratory movement displacement compensation puncture sampling.

2. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 1, characterized in that: The puncture needle includes a syringe barrel (15). One end of the syringe barrel (15) is connected to a needle tube (17). Push pieces (13) are vertically and symmetrically fixedly connected to the other end of the syringe barrel (15). The push pieces (13) are all fixedly connected to the pusher. The end of the needle tube (17) away from the syringe barrel (15) is fixedly connected to a needle tip (22). The needle tube (17) includes a biopsy inner core tube (30). A plurality of symmetric annular grooves (38) are formed on the biopsy inner core tube (30). The annular grooves (38) with different cross-sections are arranged in a spiral and staggered manner. An alloy tube (45) is fixedly sleeved outside the biopsy inner core tube (30). A plurality of piezoelectric ceramic fibers (39) are circumferentially and parallelly embedded inside the alloy tube (45). A drug slow-release layer (40), an insulating layer (41), and a radio frequency electrode layer (42) are sequentially fixedly sleeved outside the alloy tube (45). One ends of the alloy tube (45), the insulating layer (41), and the radio frequency electrode layer (42) are all fixedly connected to the syringe barrel (15). A plurality of through holes (44) communicating with the drug slow-release layer (40) are axially formed at the other ends of the insulating layer (41) and the radio frequency electrode layer (42). The biopsy inner core tube (30) is communicated with the needle tip (22). An electromagnetic positioning coil (46) is fixedly sleeved on the outer periphery of the rear end of the needle tip (22). An optical fiber array (10) and a gel tube are axially laid inside the biopsy inner core tube (30). The piezoelectric ceramic fibers (39) are all electrically connected to the controller (19). The electromagnetic positioning coil (46) is connected to a control signal.

3. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 2, wherein: An inner sleeve (37) is axially fixedly connected to the inner wall of the needle tip (22). A sliding tube (29) is slidably fitted at the front end of the inner sleeve (37). A first arc-shaped member (31) is connected to the rear end of the sliding tube (29). A first axial groove (32) is formed in the side wall of the first arc-shaped member (31) close to the radial center of the sliding tube (29). A sliding groove is formed in the side wall of the sliding tube (29) away from the first arc-shaped member (31). An injection tube (36) is fixedly connected to the rear end of the inner sleeve (37). A second arc-shaped member (35) is connected to the front end of the injection tube (36). A second axial groove (34) is formed in the side wall of the second arc-shaped member (35) close to the radial center of the injection tube (36). A sliding rail is fixedly connected to one side of the front end of the second arc-shaped member (35). The sliding rail is matched with the sliding groove. A return spring (33) is fixedly connected to the front end of the second arc-shaped member (35). The other end of the return spring (33) is fixedly connected to the first arc-shaped member (31). The first arc-shaped member (31) and the second arc-shaped member (35) are slidably matched with each other. The first axial groove (32) and the second axial groove (34) are slidably matched coaxially with each other. The injection tube (36) is communicated with the gel tube.

4. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 2, characterized in that: The alloy tube (45) is made of superelastic nickel-titanium alloy material; the drug slow-release layer (40) is made of nano-porous material, and an environmental pH value responsive group (43) is sealed at the front end of the drug slow-release layer (40); ring electrodes (28) are symmetrically laid on the outer side wall of the front end of the radiofrequency electrode layer (42), and a reference electrode is laid on the outer side wall of the rear end of the radiofrequency electrode layer (42).

5. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 1, wherein: The multi-modal integrated sensor includes an ultrasonic probe (23). The ultrasonic probe (23) is fixedly connected to the top end of the fixed arm (2). The ultrasonic probe (23) is used to detect 3D organ ultrasonic data around the lesion. The ultrasonic probe (23) is signal-connected to the controller (19).

6. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 5, wherein: The multi-modal integrated sensor further includes an optical tracker (18) and a plurality of inertial sensors. The optical tracker (18) is fixedly connected to the top end of the fixed arm (2). The reflective markers and inertial sensors equipped with the optical tracker (18) are all fixed on the skin surface of the patient's chest and abdomen. The optical tracker (18) and the inertial sensors are both signal-connected to the controller (19).

7. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 1, characterized in that: The pump assembly includes a negative pressure pump (4) and a positive pressure pump (7). The output end of the negative pressure pump (4) is communicated with a sampling tube (3). The input end of the positive pressure pump (7) is communicated with a gel tank (6). The gel tank (6) is filled with a temperature-sensitive hemostatic gel. The input end of the negative pressure pump (4) is communicated with a suction tube (5). The suction tube (5) extends upward through the syringe barrel (15) and is communicated with the biopsy inner core tube (30). The output end of the positive pressure pump (7) is communicated with a supply tube (8). The supply tube (8) extends upward through the syringe barrel (15) and the needle tube (17) and is communicated with the injection tube (36). The negative pressure pump (4) and the positive pressure pump (7) are both signal-connected to the controller (19).

8. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 1, wherein: The pusher includes a pusher motor (26). Parallel sliding grooves are opened at the bottom of the guide rail (16). The inner top wall of the sliding groove is fixedly connected to the pusher motor (26). The output end of the pusher motor (26) is coaxially and fixedly connected with a motor gear. A toothed belt (25) is engaged with the motor gear. The inner top wall of the sliding groove is fixedly connected with a snap ring. A lead screw nut (27) is slidably connected inside the snap ring. A pusher lead screw (24) is in threaded fit inside the lead screw nut (27). One end of the pusher lead screw (24) away from the needle tip (22) is fixedly connected with a pusher block (12). A clamping groove for cooperating with the pusher piece (13) is opened on the top wall of the pusher block (12). One side of the pusher block (12) close to the guide rail (16) is fixedly connected with a sliding piece (14). A blade-shaped groove is opened on the guide rail (16). The sliding piece (14) is in sliding fit with the blade-shaped groove. The pusher electrode is in signal connection with the controller (19).

9. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 1, characterized in that: The controller (19) is provided with a high-frequency generator (20) and an optical fiber strain sensor (21). The high-frequency generator (20) is connected with a plurality of cables (9). The cables (9) extend upward through the syringe barrel (15) and are fixedly connected with the annular electrode (28) and the reference electrode. The optical fiber array (10) passes through the wall of the sampling tube (3) and the syringe barrel (15) along the inner wall of the needle tube (17) and is fixedly connected with the optical fiber strain sensor (21).

10. The hepatobiliary and pancreatic clinical puncture sampling device according to claim 9, wherein: The controller (19) is also provided with an acquisition module, a model construction module, a prediction module, a guiding module, a respiratory motion compensation module and an execution module; The acquisition module is used for acquiring 3D organ ultrasound data, inertial sensing data, optical tracking data, electromagnetic positioning data, optical fiber strain curvature data and puncture tissue impedance data; The model construction module is used for constructing a 3D organ segmentation model according to the 3D organ ultrasound data, identifying the target organ and the main blood vessels and using the Monte Carlo obstacle avoidance algorithm to plan the needle insertion path; The prediction module is used for using the LSTM neural network combined with the viscoelastic biomechanical model to establish and correct the respiratory phase-organ displacement prediction model according to the three-dimensional acceleration data and angular velocity data in the inertial sensing data and the optical tracking data. The phase division in the model is to discretize the respiratory cycle into 0°-360°. Among them, the inspiratory phase: 0°-180°, the expiratory phase: 180°-360°. The real-time phase angle calculation formula is as follows: In the formula, is the instantaneous volume change rate, and V max is the volume change amount during the maximum respiratory cycle, The phase feature extraction is to calculate the instantaneous volume through the three-dimensional coordinates of the marked points of the optical tracker to extract the change rate of the thoracic cavity volume, and to extract the diaphragm movement speed through the differential of the vertical displacement of the marked point cluster of the inertial sensor; The guiding module is used for real-time reconstructing the electromagnetic positioning data and the optical fiber strain curvature data into the 3D organ segmentation model for real-time needle insertion guidance. The real-time reconstruction formula of the three-dimensional curvature is as follows: In the formula, h = 0.4mm, Control the robotic arm and the pusher motor (26) to point the puncture needle at the target lesion and avoid blood vessels and other organs; The respiratory motion compensation module is used for the time series prediction based on the LSTM neural network, to output the organ displacement prediction queue in advance, and to control the robotic arm to drive the puncture needle to translate along with the respiratory cycle, synchronously realizing respiratory motion compensation and delay compensation; An execution module, which is used to control a negative pressure pump (4) to aspirate samples after the puncture needle reaches the lesion, control a positive pressure pump (7) to supply a hemostatic gel, control the high-frequency generation inactivation of a ring electrode (28), and adjust the power of the ring electrode (28) according to the puncture tissue impedance data, so as to realize the integrated functions of sampling, inactivation, hemostasis and chemotherapy.

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