Intelligent test system for minimally invasive interventional surgical instrument

Abstract

The invention relates to the technical field of medical instrument test control, in particular to a minimally invasive interventional surgical instrument intelligent test system which comprises an organ simulation mechanism, a puncture mechanism, a monitoring module, a control module, a data analysis module and an output module. The control module is used for controlling the organ simulation unit to simulate movement under the influence of respiration and heartbeat according to organ movement data coupled and output by actual respiration data and actual heartbeat data of a human body; the monitoring module is used for collecting real-time position information of a mark point and a puncture needle on the organ simulation unit; and the data analysis module is used for comparing the real-time position information and the initial position information of the mark point, comparing a difference value between the real-time position information of the needle point and the real-time position information of the mark point, and judging whether the difference value is in a preset reasonable range. According to the invention, the interaction process of the puncture needle and the organ in the body can be obtained, so that the minimally invasive interventional surgical instrument can be evaluated.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical instrument test control, in particular to a minimally invasive interventional surgical instrument intelligent test system. BACKGROUND

[0002] Minimally invasive interventional surgery is an advanced technology that enters the body through a small incision or natural body cavity, guided by imaging equipment to achieve precise treatment of diseases. Minimally invasive interventional surgery has been widely used in clinical fields such as tumor biopsy, radiofrequency ablation, vascular intervention, and nerve block due to its small trauma and fast recovery.

[0003] The interaction process between the instrument (puncture needle, catheter, and auxiliary surgical robot) and the biological tissue (such as organs and blood vessels) in the minimally invasive interventional surgery (the real-time deformation of the tissue caused by the force generated by the instrument during operation and the motion path of the instrument itself) plays a key role in the evaluation of minimally invasive interventional surgical instruments.

[0004] The interaction process between the minimally invasive interventional surgical instruments such as puncture needles, catheters, and auxiliary surgical robots and biological tissues (such as organs and blood vessels) in the body is extremely complex, involving highly nonlinear and viscoelastic coupling. Current highly depends on in-vivo experiments, but the ethical review is strict, the cost is high, and the cycle is long.

[0005] Therefore, the present application provides a minimally invasive interventional surgical instrument intelligent test system and method to simulate puncture needle surgery and obtain the interaction process between the puncture needle and the biological tissue in the body, thereby realizing the evaluation of minimally invasive interventional surgical instruments. SUMMARY

[0006] The purpose of the present application is to provide a minimally invasive interventional surgical instrument intelligent test system to solve the technical problem that the interaction process between the puncture needle and the biological tissue in the body cannot be obtained in the prior art.

[0007] To solve the above technical problems, the present application provides a minimally invasive interventional surgical instrument intelligent test system, which comprises an organ simulation mechanism, a puncture mechanism, a monitoring module, a control module, a data analysis module, and an output module. The organ simulation mechanism comprises an organ driving mechanism and an organ simulation unit for simulating a real organ of a human body; the organ driving mechanism is connected with the control module; the organ driving mechanism is used to drive the organ simulation unit to perform three-dimensional motion; the organ simulation unit comprises a marker point; The puncture mechanism comprises a puncture driving mechanism and a puncture needle connected with the puncture driving mechanism; the puncture driving mechanism is used to drive the puncture needle to puncture on the organ simulation unit; The control module is used to control the organ drive mechanism based on the organ motion data coupled from the actual human breathing data and actual heartbeat data, so that the organ simulation unit can perform three-dimensional motion to simulate the motion under the influence of breathing and heartbeat. The monitoring module is used to collect the initial position information of the marker point, the real-time position information of the marker point and the puncture needle, and send the initial position information and the real-time position information to the data analysis module; The data analysis module is used to compare the real-time position information and the initial position information of the marker point, and to calculate and analyze the real-time offset information of the marker point. The output module is used to output the real-time offset information of the marker point and the real-time position information of the puncture needle.

[0008] Furthermore, the organ simulation unit includes a liver model, a blood vessel model, and a tumor model; the blood vessel model and the tumor model are both disposed inside the liver model; the liver model, the blood vessel model, and the tumor model are all provided with the marker points; the liver model is fixed to the organ driving mechanism; The monitoring module is used to simultaneously collect real-time location information of marker points on the liver model, the tumor model, and the blood vessel model; The data analysis module is also used to calculate and analyze the real-time position information of the needle tip of the puncture needle based on the real-time position information of the puncture needle, and compare the difference between the real-time position information of the needle tip and the real-time position information of the marker point on the blood vessel model to determine whether the difference is within a preset reasonable range.

[0009] Furthermore, the data analysis module is also used to compare the difference between the real-time position information of the puncture needle tip and the real-time position information of the marker point on the tumor model, and to determine whether the difference is within a preset reasonable range.

[0010] Furthermore, the organ simulation unit also includes a skin simulation layer; the skin simulation layer includes an epidermal simulation layer, a dermal simulation layer, and a subcutaneous tissue simulation layer arranged from top to bottom; the subcutaneous tissue simulation layer covers the liver model.

[0011] Furthermore, the organ simulation unit also includes a constraint body; the constraint body encloses the liver model so that the liver model is located inside the constraint body; the constraint body is used to constrain the liver model; the subcutaneous tissue simulation layer covers the constraint body; the constraint body is made of transparent hydrogel.

[0012] Furthermore, the organ simulation unit includes a fixing box with an opening at the top; the side walls of the fixing box are made of transparent material; the bottom of the fixing box is fixed to the organ driving mechanism; the four sides of the restraint body are fixed to the side walls of the fixing box; the bottom of the restraint body is fixed to the bottom wall of the fixing box; a base layer is provided between the restraint body and the fixing box; the epidermal simulation layer, the dermal simulation layer, the subcutaneous tissue simulation layer, the restraint body, and the base layer are all located inside the fixing box; the base layer is made of non-transparent hydrogel.

[0013] Furthermore, the monitoring module includes an XZ-direction camera, a YZ-direction camera, and a transmission module; The XZ-direction camera is used to acquire the initial X and Z-direction position information of the marker point, and the real-time X and Z-direction position information of the marker point and the puncture needle; the YZ-direction camera is used to acquire the initial Y and Z-direction position information of the marker point, and the real-time Y and Z-direction position information of the marker point and the puncture needle. The transmission module is used to send the initial position information of the marker point, the real-time position information of the marker point and the puncture needle to the data analysis module.

[0014] This invention also provides an intelligent testing method for minimally invasive interventional surgical instruments, which is applied to the aforementioned intelligent testing system for minimally invasive interventional surgical instruments. The method includes: The puncture drive mechanism drives the puncture needle to perform puncture on the organ simulation unit; The control module controls the organ drive mechanism by coupling organ motion data with actual human breathing data and actual heartbeat data, so that the organ simulation unit can perform three-dimensional motion to simulate the motion under the influence of breathing and heartbeat. The monitoring module collects the initial position information of the marker points on the organ simulation unit, as well as the real-time position information of the marker points and the puncture needle, and sends the initial position information and the real-time position information to the data analysis module. The data analysis module compares the real-time position information and the initial position information of the marker point, and calculates and analyzes the real-time offset information of the marker point; The output module outputs the real-time offset information of the marker point and the real-time position information of the puncture needle.

[0015] Furthermore, the organ simulation unit includes a liver model, a blood vessel model, and a tumor model; the blood vessel model and the tumor model are both disposed inside the liver model; the liver model, the blood vessel model, and the tumor model are all provided with the marker points; the liver model is fixed to the organ driving mechanism; The monitoring module simultaneously collects real-time location information of marker points on the liver model, the tumor model, and the blood vessel model; The data analysis module calculates and analyzes the real-time position information of the needle tip based on the real-time position information of the puncture needle, and compares the difference between the real-time position information of the needle tip and the real-time position information of the marker point on the blood vessel model to determine whether the difference is within a preset reasonable range.

[0016] Furthermore, the data analysis module compares the difference between the real-time position information of the puncture needle tip and the real-time position information of the marker point on the tumor model, and determines whether the difference is within a preset reasonable range.

[0017] By adopting the above technical solution, the present invention has the following beneficial effects: The intelligent testing system for minimally invasive interventional surgical instruments provided by this invention, during operation, recognizes that human organs (such as the liver and kidneys) are not static during minimally invasive interventional surgery but move due to respiration and heartbeat. Therefore, the control module of this invention first controls the movement of the organ driving mechanism based on the organ movement data coupled from actual respiratory and heartbeat data. This causes the organ driving mechanism to drive the organ simulation unit to move according to the actual human body condition, thereby simulating the real organ state during minimally invasive interventional surgery. This invention controls the organ simulation unit's movement by coupling actual respiratory and heartbeat data, making the organ simulation unit more accurately simulate the real state of human organs, improving the accuracy of the surgical simulation test, and thus improving the accuracy of the information output by the subsequent output module.

[0018] While the organ simulation unit moves as described above, the puncture drive mechanism drives the puncture needle to perform a puncture operation on the organ simulation unit. During actual puncture surgery in the human body, the internal tissues of organs (liver, kidneys, etc.) deform due to the pressure of the puncture needle, causing internal displacement (tumors, blood vessels). Therefore, this invention sets marker points within the organ simulation unit. The monitoring module collects the initial position information of the marker points. Simultaneously with the puncture needle puncturing the organ simulation unit, the monitoring module collects the real-time position information of the marker points and the real-time position information of the puncture needle and sends it to the data analysis module. The data analysis module compares the real-time position information of the marker points with the initial position information to calculate and analyze the real-time offset information of the marker points. The output module outputs the real-time offset information of the marker points and the real-time position information of the puncture needle. The real-time offset information of the marker points reflects the tissue deformation within the organ simulation unit (liver model, etc.) during the surgery. The real-time position information of the puncture needle reflects the movement path of the puncture needle during the surgery.

[0019] This invention can obtain the interaction process between the puncture needle and the internal organs by using the real-time offset information of the marker point and the real-time position information of the puncture needle, thereby realizing the evaluation of minimally invasive interventional surgical instruments. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the structure of the intelligent testing system for minimally invasive interventional surgical instruments provided in an embodiment of the present invention; Figure 2 for Figure 1 A schematic diagram of the structure of the central organ drive mechanism; Figure 3 for Figure 1 Another structural diagram of the central organ drive mechanism; Figure 4 This is a schematic diagram of the structure of the organ simulation unit provided in an embodiment of the present invention; Figure 5 for Figure 4 A schematic diagram of the structure of the middle organ.

[0022] Figure label: 1-Organ simulation mechanism; 2-Monitoring module; 3-Puncture mechanism; 4- Computer; 5- NDI optical positioning system; 6- Optical positioning platform; 11-Organ driving mechanism; 12-Organ simulation unit; 21-XZ-direction camera; 22-YZ direction camera; 31-puncture needle; 32-needle hub; 33 - Puncture drive mechanism; 111 - X-axis drive motor; 112 - X-axis displacement platform; 113 - Y-axis drive motor; 114 - Y-axis displacement platform; 115 - Z-axis drive motor; 116 - Z-axis displacement platform; 121 - Epidermal simulation layer; 122 - Dermal simulation layer; 123 - Subcutaneous tissue simulation layer; 124 - Liver model; 125 - Blood vessel model; 126 - Tumor model; 127 - Marker points; 128 - Fixation box; 129 - Constraint body; 1210 - Base layer. Detailed Implementation

[0023] The embodiments of this application will now be described in detail with reference to the figures, including one or more examples of embodiments of this application. Each example is provided for the purpose of explaining this application and not for limiting it. In fact, those skilled in the art will appreciate that various modifications and variations can be made to this application without departing from the scope or spirit of this application. For example, a feature illustrated or described as part of one embodiment may be used with another embodiment to produce yet another embodiment. Therefore, it is intended that this application cover such modifications and variations, which are within the scope of the appended claims and their equivalents. As used in this specification, the terms “first,” “second,” etc., are used interchangeably to distinguish one component from another and are not intended to indicate the location or importance of the components. As used in this specification, unless the context clearly indicates otherwise, the terms “a,” “an,” “the,” and “the” are intended to indicate the presence of one or more elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be other elements in addition to those listed.

[0024] Referring now to the accompanying drawings, in which the same numbers in all the drawings denote the same elements, the present invention will be further explained and described below in conjunction with specific embodiments.

[0025] like Figures 1 to 5 As shown, the intelligent testing system for minimally invasive interventional surgical instruments provided in this embodiment of the invention includes an organ simulation mechanism 1, a puncture mechanism 3, a monitoring module 2, a control module, a data analysis module, and an output module. The organ simulation mechanism 1 includes an organ driving mechanism 11 and an organ simulation unit 12 for simulating real human organs; the organ driving mechanism 11 is connected to the control module; the organ driving mechanism 11 is used to drive the organ simulation unit 12 to perform three-dimensional motion; the organ simulation unit 12 includes marker points 127; The puncture mechanism 3 includes a puncture drive mechanism 33 and a puncture needle 31 connected to the puncture drive mechanism 33; the puncture drive mechanism 33 is used to drive the puncture needle 31 to perform puncture on the organ simulation unit 12. The control module is used to control the organ drive mechanism 11 based on the organ motion data coupled from the actual human breathing data and actual heartbeat data, so that the organ simulation unit 12 can perform three-dimensional motion to simulate the motion under the influence of breathing and heartbeat. The monitoring module 2 is used to collect the initial position information of the marker point 127, the real-time position information of the marker point 127 and the puncture needle 31, and send the initial position information and the real-time position information to the data analysis module; The data analysis module is used to compare the real-time position information and the initial position information of marker point 127, and to calculate and analyze the real-time offset information of marker point 127. The output module is used to output the real-time offset information of the marker point 127 and the real-time position information of the puncture needle 31.

[0026] The three-dimensional motion mentioned in this invention refers to motion along the X-axis, Y-axis, and Z-axis directions. The X-axis direction in this invention refers to... Figure 1 The direction from camera 22 to organ simulation mechanism 1 along the YZ axis; the Y-axis direction refers to... Figure 1 The direction from camera 21 to organ simulation mechanism 1 along the XZ axis; the Z-axis direction refers to... Figure 1 The vertical direction (height direction) in the middle.

[0027] The intelligent testing system for minimally invasive interventional surgical instruments provided in this invention, during operation, recognizes that human organs (such as the liver and kidneys) are not static during minimally invasive interventional surgery but undergo corresponding movements due to the combined effects of respiration and heartbeat. Therefore, the control module of this invention first controls the movement of the organ driving mechanism 11 based on the organ movement data coupled from actual respiratory and heartbeat data. This causes the organ driving mechanism 11 to drive the organ simulation unit 12 to move according to the actual human condition, thereby simulating the real organ state during minimally invasive interventional surgery. This invention controls the organ simulation unit 12 to move accordingly by coupling the organ movement data from actual respiratory and heartbeat data, making the organ simulation unit 12 more accurately simulate the real state of human organs, improving the accuracy of the surgical simulation test, and thus improving the accuracy of the information output by the subsequent output module. In other words, this invention can accurately drive the testing system to reproduce the dynamic deformation process of organs affected by respiration and heartbeat in three-dimensional space. This dynamic environment provides crucial testing conditions for minimally invasive puncture instruments.

[0028] While the organ simulation unit 12 moves as described above, the puncture drive mechanism 33 drives the puncture needle 31 to perform a puncture operation on the organ simulation unit 12. Because during actual puncture surgery in the human body, the internal tissues of organs (liver, kidneys, etc.) deform due to the squeezing force of the puncture needle 31, causing the internal structures (tumors, blood vessels) to shift. Therefore, this invention sets a marker point 127 within the organ simulation unit 12. The monitoring module collects the initial position information of the marker point 127. Then, the puncture needle 31 punctures the organ simulation unit 12. Simultaneously, the monitoring module collects the real-time position information of the marker point 127 and the real-time position information of the puncture needle 31 and sends them to the data analysis module. The data analysis module compares the real-time position information of the marker point 127 with the initial position information, thereby calculating and analyzing the real-time offset information of the marker point 127. The output module outputs the real-time offset information of the marker point 127 and the real-time position information of the puncture needle 31. The real-time offset information of marker point 127 can reflect the tissue deformation inside organ simulation unit 12 (liver model 124, etc.) during the operation. The real-time position information of puncture needle 31 can reflect the movement path of puncture needle 31 during the operation.

[0029] The present invention can obtain the interaction process between the puncture needle 31 and the internal organs by using the real-time offset information of the marker point 127 and the real-time position information of the puncture needle 31, thereby realizing the evaluation of minimally invasive interventional surgical instruments.

[0030] Preferably, the monitoring module includes at least two calibrated industrial cameras. These cameras establish a unified world coordinate system with the organ-driven mechanism, and the camera coordinates are converted to the organ coordinate system using known rigid body transformation relationships. Calibration employs the Zhang calibration method, with a calibration accuracy better than 1 mm.

[0031] In practice, the output module can output the above information to computer 4 for the tester to view and store. The location information referred to in this invention can be three-dimensional coordinates in practice.

[0032] Experiments have shown that the aforementioned human respiratory data is as follows: with the Z-axis displacement platform 116 as the main displacement direction (amplitude range 10-30mm, frequency 0.2-0.5Hz), the secondary coupled motions of the X-axis displacement and Y-axis displacement are simultaneously superimposed to form the characteristic trajectory of the diaphragm's rise and fall (generating respiratory data).

[0033] The aforementioned human heartbeat data consists of a composite harmonic with adjustable phase difference across the X, Y, and Z axes (fundamental frequency 1-2Hz, single-axis amplitude 0.1-1mm), simulating the micro-displacement of tissues caused by heartbeats. Users can independently adjust the amplitude, frequency, waveform envelope, and inter-axial phase delay of each axis to construct a non-linearly coupled organ motion trajectory.

[0034] The aforementioned marker point 127 can be implemented in several ways, such as setting the material at the location of marker point 127 to be different from the material at the unmarked location. Alternatively, the color at the location of marker point 127 can be different from the color at the unmarked location. The latter, a different color, is preferred, as it ensures the consistency of the material of the organ simulation unit 12, thus more closely resembling the actual condition of human organs and improving test accuracy.

[0035] The organ simulation unit 12 simulates organs such as the liver and kidneys. In a preferred embodiment of the present invention, the organ simulation unit 12 includes a liver model 124, a blood vessel model 125, and a tumor model 126. The blood vessel model 125 and the tumor model 126 are both disposed inside the liver model 124. Marker points 127 are provided on the liver model 124, the blood vessel model 125, and the tumor model 126. The liver model 124 is fixed to the organ driving mechanism 11. The monitoring module 2 is used to simultaneously collect the real-time location information of the marker points 127 on the liver model 124, tumor model 126, and blood vessel model 125; The data analysis module is also used to calculate and analyze the real-time position information of the needle tip of the puncture needle 31 based on the real-time position information of the puncture needle 31, and compare the difference between the real-time position information of the needle tip and the real-time position information of the marked point 127 on the blood vessel model 125 to determine whether the difference is within a preset reasonable range.

[0036] In this embodiment, during the operation, due to the force of the puncture needle 31, the internal tissue of the liver model 124, the tumor model 126, and the blood vessel model 125 are all in a dynamic state. By collecting the real-time position information of the marked points 127 on the liver model 124, the tumor model 126, and the blood vessel model 125, the real-time change status of the three can be known. At the same time, by comparing the difference between the real-time position of the needle tip and the blood vessel model 125 (in actual operation, the difference between the three-dimensional coordinate values ​​of the two), the distance between the needle tip and the blood vessel model 125 can be known, and it can be determined whether the difference is within a preset reasonable range. Thus, it can be known whether the needle tip is within a safe position range during the operation.

[0037] The "preset reasonable range" is a threshold set based on the diameter of the blood vessel being tested and the allowable error of the tissue. It is entered by the user through the testing software interface before the test.

[0038] Based on the above embodiments, the data analysis module is further used to compare the difference between the real-time position information of the needle tip of the puncture needle 31 and the real-time position information of the marker point 127 on the tumor model 126 (in actual operation, the difference between their three-dimensional coordinate values) to determine whether the difference is within a preset reasonable range. Similarly, the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the tumor model 126 can reflect the positional relationship between the needle tip and the tumor model 126; determining whether the difference is within a preset reasonable range can facilitate the prediction of whether the needle tip can accurately reach the position of the tumor model 126 during the surgical procedure.

[0039] Based on the above embodiments, further, there are multiple marker points 127 on the blood vessel model 125; the data analysis module calculates and analyzes the real-time distance between each marker point 127 on the blood vessel model 125 and the needle tip. The distances between multiple marker points 127 and the needle tip can more accurately reflect the real-time position of the needle tip.

[0040] Preferably, the output module outputs the judgment results of the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the blood vessel model 125, the judgment results of the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the tumor model 126, and the real-time distance between multiple marker points 127 on the blood vessel model 125. This facilitates the tester's review of the study.

[0041] Preferably, the liver model 124 is cast from translucent silicone, with its elastic modulus precisely controlled between 12-18 kPa to match the mechanical properties of real liver parenchyma. Internally, a tree-like network of branching cavities with a diameter of 1-5 mm is formed using a sacrificial material method. This model has ≥85% visible light transmittance, supporting fluoroscopic observation of the internal vascular model 125 and tumor model 126 structures.

[0042] The vascular model 125 is composed of an elastic silicone tube embedded in the cavity of the liver model 124. The main trunk and branch channels are injected with red dye to create a color contrast while maintaining a semi-transparent property.

[0043] Tumor model 126 is molded into an irregular sphere using a non-uniform silicone composite (which can be Flexible 80A Resin). The hardness gradient change in the edge area is achieved through a layered gradient casting process, which accurately simulates the biomechanical properties of the tumor model 126-liver tissue interface.

[0044] The aforementioned organ-driving mechanism 11 can be implemented in various ways, for example: it can be a robotic arm capable of three-dimensional motion, or it can be implemented using a mechanism capable of controlling linear motion in three directions, specifically as follows: Figure 2 and Figure 3As shown, the organ driving mechanism 11 includes an X-axis drive motor 111, an X-axis displacement platform 112, a Y-axis drive motor 113, a Y-axis displacement platform 114, a Z-axis drive motor 115, and a Z-axis displacement platform 116. The Y-axis displacement platform 114 is fixedly connected to the Y-axis drive motor 113. The Y-axis drive motor 113 drives the Y-axis displacement platform 114 to move along the Y direction. The organ simulation unit 12 is fixed on the Y-axis displacement platform 114. The X-axis displacement platform 112 is fixedly connected to the X-axis drive motor 111. The X-axis drive motor 111 drives the X-axis displacement platform 112 to move along the X direction. The Y-axis displacement platform 114 is disposed on the X-axis displacement platform 112 and slidably connected to the X-axis displacement platform 112. The Z-axis displacement platform 116 is fixedly connected to the Z-axis drive motor 115. The Z-axis drive motor 115 drives the Z-axis displacement platform 116 to move along the Z direction. The X-axis displacement platform 112 is disposed on the Z-axis displacement platform 116 and slidably connected to the Z-axis displacement platform 116. During operation, the Z-axis drive motor 115 drives the Z-axis displacement platform 116 to move along the Z-axis. Simultaneously, the X-axis drive motor 111, X-axis displacement platform 112, and Y-axis drive motors 113 and Y-axis displacement platform 114 move along the Z-axis, thereby driving the organ simulation unit 12 to move along the Z-axis. The X-axis drive motor 111 drives the X-axis displacement platform 112 to move along the X-axis, while simultaneously driving the Y-axis drive motor 113, Y-axis displacement platform 114, and organ simulation unit 12 to move along the X-axis. The Y-axis drive motor 113 drives the Y-axis displacement platform 114 to move along the Y-axis, while simultaneously driving the organ simulation unit 12 to move along the Y-axis. This achieves three-dimensional motion of the organ simulation unit 12 through motor drive in three directions, thus simulating the motion of a real organ. The advantages of this method in this embodiment are simple structure, convenient setup, and cost savings. Preferably, each axial drive motor has a repeatability accuracy of ≤5μm, a backlash error compensation capability of ±0.01mm, and a dynamic response bandwidth of 0.1-20Hz.

[0045] like Figure 4 and Figure 5 As shown, based on the above embodiment, the organ simulation unit 12 further includes a skin simulation layer; the skin simulation layer includes an epidermal simulation layer 121, a dermal simulation layer 122, and a subcutaneous tissue simulation layer 123 arranged from top to bottom; the subcutaneous tissue simulation layer 123 covers the liver model 124. This can simulate the structure of real human skin covering the surface of an organ, thereby accurately simulating the stress and other conditions on the organ and improving the accuracy of the test.

[0046] The epidermal simulation layer 121 is composed of an ultra-thin medical silicone membrane with a thickness of 0.05±0.01mm. Its surface replicates the micro-texture of human skin and is coated with a biomimetic hydrophobic coating. By controlling the hardness and surface tension of the silicone, this layer can simulate the elastic deformation resistance and breakthrough feeling of real epidermal tissue at the moment of contact with the tip of the puncture needle 31.

[0047] The dermal simulation layer 122 is cast from a non-transparent modified gel with a thickness of 1.0±0.2 cm, with an internally embedded collagen fiber network framework structure. The gel is acoustically modified to achieve an acoustic impedance matching of 1.60–1.65 MRayl, and reproduces the viscoelastic response in terms of mechanical properties (relaxation modulus 0.5–2.0 MPa·s, loss factor tanδ=0.1–0.3). During puncture, it dynamically exhibits the compression deformation field of the gel around the needle tract.

[0048] The subcutaneous tissue simulation layer 123 consists primarily of a porous gel with a thickness of 3.0 ± 0.5 cm, internally containing embedded fat-simulating microspheres (2-5 mm in diameter). The gel porosity (30%-50%) and microsphere density (100-200 microspheres / cm³) were adjusted accordingly. 3 This layer can simulate the buffering effect of real subcutaneous adipose tissue. When the puncture needle 31 passes through, it generates a load-displacement curve with nonlinear characteristics. The slope of the resistance peak attenuation is more than 90% correlated with the clinical measured data.

[0049] like Figure 4 As shown, based on the above embodiment, the organ simulation unit 12 further includes a constraint body 129; the constraint body 129 encloses the liver model 124 so that the liver model 124 is located inside the constraint body 129; the constraint body 129 is used to constrain the liver model 124; a subcutaneous tissue simulation layer 123 covers the constraint body 129; the constraint body 129 is made of transparent hydrogel. The constraint body 129 is formed by injection molding using a multi-cavity injection molding process, forming a uniform coating layer around the core liver model 124, simulating the biomechanical properties of the liver model 124's membrane, and improving the accuracy of the test.

[0050] like Figure 4As shown, based on the above embodiment, the organ simulation unit 12 further includes a fixing box 128 with an opening at the top; the side walls of the fixing box 128 are made of transparent material; the bottom of the fixing box 128 is fixed to the organ driving mechanism 11; the restraint body 129 is fixed to the side walls of the fixing box 128 on all four sides; the bottom of the restraint body 129 is fixed to the bottom wall of the fixing box 128; a base layer 1210 is provided between the restraint body 129 and the fixing box 128; the epidermal simulation layer 121, the dermal simulation layer 122, the subcutaneous tissue simulation layer 123, the restraint body 129, and the base layer 1210 are all located inside the fixing box 128, and the base layer 1210 is made of non-transparent hydrogel. The fixing box 128 can fix the restraint body 129 on all four sides to prevent shaking.

[0051] Preferably, the base layer 1210 is composed of a non-transparent hydrogel with a thickness of 0.5±0.1cm and an elastic modulus controlled within the range of 50-100kPa, serving as a mechanical support platform for the overall biomimetic structure. Preferably, this layer forms a fixed constraint with the bottom surface of the fixation box 128 during the perfusion and curing stage, ensuring no misalignment with the connection to the Y-axis displacement platform 114. Preferably, the hydrogel has a visible light transmittance of ≥92% and an elastic modulus precisely controlled within 0.5-1.5kPa to match the physiological capsule properties. During perfusion, its tightness with the liver model 124 is ensured by an internal mold, and seamless adhesion (bonding strength ≥0.3MPa) is achieved with the sidewall of the fixation box 128 via molecular cross-linking technology, thereby constructing a three-dimensional soft constraint body 129 system for the liver model 124.

[0052] The stability of the constraint body 129 is ensured through a layered composite bonding mechanism: its bottom layer forms a chemical bond with the non-transparent hydrogel of the base layer 1210 at the cross-linking interface, achieving rigid anchoring of the mechanical support platform; the top layer forms a mechanical interlock with its periphery through the extended structures of the epidermal simulation layer 121, the dermal simulation layer 122, and the subcutaneous tissue simulation layer 123, maintaining an interlayer displacement tolerance of ≤0.1mm during puncture testing. This design allows the organ model to maintain internal and external constraint coupling under dynamic motion, accurately replicating the stress transmission path of soft tissue during clinical puncture.

[0053] The puncture drive mechanism 33 can be implemented in various ways, such as a robotic arm capable of three-dimensional motion, or a mechanism capable of controlling linear motion in three directions.

[0054] Based on the above embodiments, the puncture mechanism 3 further includes a six-degree-of-freedom force sensor; the puncture needle 31 is fixed to the puncture drive mechanism 33 via a needle holder 32; the six-degree-of-freedom sensor is disposed on the needle holder 32; the six-degree-of-freedom force sensor is used to collect and calculate the mechanical parameters of the needle holder 32 during the puncture process in real time. This sensor quantifies the axial puncture resistance, lateral shear force, and torque components, and can accurately capture the complete dynamic response of the needle holder 32-tissue interaction. The six-degree-of-freedom sensor can monitor the force and torque data of the needle holder 32 during the puncture process in real time, and simultaneously sense and quantify the vertical puncture force and the horizontal tangential force, thereby accurately measuring all mechanical responses (including axial pressure, lateral force, and torque) when the needle holder 32 contacts the tissue. The system collects data from the sensor at high speed, calculates the force on the needle holder 32 in real time, and performs dynamic analysis based on the mechanical changes during the puncture process. Precise monitoring of mechanical data helps doctors assess in real time the insertion speed and force of the puncture needle 31, as well as the tissue location and tissue response during the puncture process, ensuring that over-puncture or improper force does not occur during the operation. In addition, the six-degree-of-freedom sensor and monitoring module 2 are used in tandem, that is, the mechanical parameters of the needle hub 32 are used in conjunction with the position information of the marker point 127 and the puncture needle 31 collected by the monitoring module 2 to provide comprehensive surgical feedback, helping to improve surgical precision and ensure safety.

[0055] like Figure 1 As shown, based on the above embodiment, the monitoring module 2 further includes an XZ-direction camera 21, a YZ-direction camera 22, and a transmission module. The XZ-direction camera 21 is used to collect the initial X and Z-direction position information of the marker point 127 and the real-time X and Z-direction position information of the marker point 127 and the puncture needle 31. The YZ-direction camera 22 is used to collect the initial Y and Z-direction position information of the marker point 127 and the real-time Y and Z-direction position information of the marker point 127 and the puncture needle 31. The transmission module is used to send the initial position information of the marker point 127 and the real-time position information of the marker point 127 and the puncture needle 31 to the data analysis module. Submillimeter-level tissue displacement measurement and needle trajectory monitoring can be achieved through dual cameras. Preferably, the dual cameras are respectively fixed on a finely adjustable manual base, and the focal length parameters and distortion coefficients are obtained through three-dimensional reconstruction calibration to establish a transformation matrix from the camera coordinate system to the world coordinate system (spatial registration error ≤ 0.05 mm).

[0056] This invention can construct a highly simulated biomechanical environment, enabling real-time, accurate, and synchronous quantitative acquisition of multi-physics field information during the operation of instruments in dynamic organ environments. Based on this, multi-dimensional quantitative evaluation of the tested minimally invasive interventional instruments can be performed, providing efficient and reliable platform support for instrument structure optimization.

[0057] Preferably, before the XZ-direction camera 21 and YZ-direction camera 22 acquire the position information of the marker point 127, the accuracy of the two cameras is evaluated. An NDI optical positioning system 5 can be used. Specifically, the two cameras and the camera within the NDI optical positioning system 5 simultaneously capture the position information of the calibration ball within the NDI optical positioning system 5 and calculate the spatial position of the calibration ball. By comparing the calculated spatial positions of the calibration ball, the error between the two cameras and the NDI optical positioning system 5 can be determined. Since the NDI optical positioning system 5 is a high-precision instrument, the user can determine the camera accuracy through the aforementioned error, ensuring the overall system testing accuracy.

[0058] During the experiment, the organ simulation mechanism 1, the puncture mechanism 3, the control module, the monitoring module 2, the data analysis module, and the output module were all set on the optical positioning platform 6.

[0059] In another aspect, the present invention provides an intelligent testing method for minimally invasive interventional surgical instruments, which is applied to the aforementioned intelligent testing system for minimally invasive interventional surgical instruments. The method includes: The puncture drive mechanism 33 drives the puncture needle 31 to perform puncture on the organ simulation unit 12; The control module controls the organ drive mechanism 11 by coupling the actual human breathing data and actual heartbeat data to output organ motion data, so that the organ simulation unit 12 can perform three-dimensional motion to simulate the motion under the influence of breathing and heartbeat. The monitoring module collects the initial position information of the marker point 127 on the organ simulation unit 12, the real-time position information of the marker point 127 and the puncture needle 31, and sends the initial position information and the real-time position information to the data analysis module. The data analysis module compares the real-time position information and the initial position information of marker point 127, and calculates and analyzes the real-time offset information of marker point 127. The output module outputs the real-time offset information of marker point 127 and the real-time position information of puncture needle 31.

[0060] The method provided by this invention, during operation, recognizes that human organs (liver, kidneys, etc.) are not in a static state during minimally invasive interventional surgery but undergo corresponding movements due to the combined effects of respiration and heartbeat. Therefore, the control module of this invention first controls the movement of the organ driving mechanism 11 based on the organ movement data coupled from actual human respiration and heartbeat data. This causes the organ driving mechanism 11 to drive the organ simulation unit 12 to move according to the actual human condition, thereby simulating the real organ state during minimally invasive interventional surgery. This invention controls the organ simulation unit 12 to move accordingly by coupling the organ movement data from actual human respiration and heartbeat data, making the organ simulation unit 12 more accurately simulate the real state of human organs, improving the accuracy of the surgical simulation test, and thus improving the accuracy of the information output by the subsequent output module. In other words, this invention can accurately drive the testing system to reproduce the dynamic deformation process of organs affected by respiration and heartbeat in three-dimensional space. This dynamic environment provides crucial testing conditions for minimally invasive puncture instruments.

[0061] While the organ simulation unit 12 moves as described above, the puncture drive mechanism 33 drives the puncture needle 31 to perform a puncture operation on the organ simulation unit 12. During actual puncture surgery in the human body, the internal tissues of organs (liver, kidneys, etc.) deform due to the squeezing force of the puncture needle 31, causing the internal structures (tumors, blood vessels) to shift. Therefore, this invention sets a marker point 127 within the organ simulation unit 12. After the monitoring module collects the initial position information of the marker point 127, the puncture needle 31 punctures the organ simulation unit 12. Simultaneously, the monitoring module collects the real-time position information of the marker point 127 and the real-time position information of the puncture needle 31 and sends them to the data analysis module. The data analysis module compares the real-time position information of the marker point 127 with the initial position information to calculate and analyze the real-time offset information of the marker point 127. The output module outputs the real-time offset information of the marker point 127 and the real-time position information of the puncture needle. The real-time offset information of marker point 127 can reflect the tissue deformation inside organ simulation unit 12 (liver model 124, etc.) during the operation. The real-time position information of puncture needle 31 can reflect the movement path of puncture needle 31 during the operation.

[0062] The present invention can obtain the interaction process between the puncture needle 31 and the internal organs by using the real-time offset information of the marker point 127 and the real-time position information of the puncture needle 31, thereby realizing the evaluation of minimally invasive interventional surgical instruments.

[0063] Based on the above embodiments, the organ simulation unit 12 further includes a liver model 124, a blood vessel model 125, and a tumor model 126; both the blood vessel model 125 and the tumor model 126 are disposed inside the liver model 124; each of the liver model 124, blood vessel model 125, and tumor model 126 is provided with a marker point 127; the liver model 124 is fixed to the organ driving mechanism 11; the monitoring module 2 simultaneously collects the real-time position information of the marker points 127 on the liver model 124, tumor model 126, and blood vessel model 125; the data analysis module calculates and analyzes the real-time position information of the needle tip of the puncture needle 31 based on the real-time position information of the puncture needle 31, and compares the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the blood vessel model 125 to determine whether the difference is within a preset reasonable range. The principle and beneficial effects of this embodiment are the same as above, and will not be repeated here.

[0064] Based on the above embodiments, the data analysis module further compares the difference between the real-time position information of the needle tip of the puncture needle 31 and the real-time position information of the marker point 127 on the tumor model 126, and determines whether the difference is within a preset reasonable range. The principle and beneficial effects of this embodiment are the same as above, and will not be repeated here.

[0065] Based on the above embodiment, further, there are multiple marker points 127 on the blood vessel model 125; the data analysis module calculates and analyzes the real-time distance between each marker point 127 on the blood vessel model 125 and the needle tip. The principle and beneficial effects of this embodiment are the same as above, and will not be repeated here.

[0066] Preferably, the output module outputs the judgment results of the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the blood vessel model 125, the judgment results of the difference between the real-time position information of the needle tip and the real-time position information of the marker point 127 on the tumor model 126, and the real-time distance between multiple marker points 127 on the blood vessel model 125. This facilitates the tester's review of the study.

[0067] Based on the above embodiments, the monitoring module 2 further includes an XZ-direction camera 21 and a YZ-direction camera 22. The XZ-direction camera 21 is used to collect the initial X and Z-direction position information of the marker point 127 and the real-time X and Z-direction position information of the marker point 127 and the puncture needle 31. The YZ-direction camera 22 is used to collect the initial Y and Z-direction position information of the marker point 127 and the real-time Y and Z-direction position information of the marker point 127 and the puncture needle 31. Before the XZ-direction camera 21 and the YZ-direction camera 22 start working, the accuracy of the XZ-direction camera 21 and the YZ-direction camera 22 is evaluated using the NDI optical positioning system 5. The specific principle is the same as above and will not be repeated here.

[0068] This specification uses examples to disclose this application, including preferred embodiments, and also enables those skilled in the art to practice this application, including making and using any apparatus or system and performing any incorporated methods. The patentable scope of this application is defined by the claims and may include other embodiments conceived by those skilled in the art. Such other embodiments are deemed to be within the scope of the claims if they include structural elements that are not different from the literal language of the claims, or if they include equivalent structural elements that are not substantially different from the literal language of the claims.

Claims

1. An intelligent testing system for minimally invasive interventional surgical instruments, characterized in that, It includes an organ simulation mechanism, a puncture mechanism, a monitoring module, a control module, a data analysis module, and an output module; The organ simulation mechanism includes an organ driving mechanism and an organ simulation unit for simulating real human organs; the organ driving mechanism is connected to the control module; the organ driving mechanism is used to drive the organ simulation unit to perform three-dimensional motion; the organ simulation unit includes marker points; The puncture mechanism includes a puncture drive mechanism and a puncture needle connected to the puncture drive mechanism; the puncture drive mechanism is used to drive the puncture needle to puncture the organ simulation unit. The control module is used to control the organ drive mechanism based on the organ motion data coupled from the actual human breathing data and actual heartbeat data, so that the organ simulation unit can perform three-dimensional motion to simulate the motion under the influence of breathing and heartbeat. The monitoring module is used to collect the initial position information of the marker point, the real-time position information of the marker point and the puncture needle, and send the initial position information and the real-time position information to the data analysis module; The data analysis module is used to compare the real-time position information and the initial position information of the marker point, and to calculate and analyze the real-time offset information of the marker point. The output module is used to output the real-time offset information of the marker point and the real-time position information of the puncture needle.

2. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 1, characterized in that, The organ simulation unit includes a liver model, a blood vessel model, and a tumor model; Both the vascular model and the tumor model are disposed inside the liver model; the liver model, the vascular model, and the tumor model are all provided with the marker points; the liver model is fixed to the organ driving mechanism; The monitoring module is used to simultaneously collect real-time location information of marker points on the liver model, the tumor model, and the blood vessel model; The data analysis module is also used to calculate and analyze the real-time position information of the needle tip of the puncture needle based on the real-time position information of the puncture needle, and compare the difference between the real-time position information of the needle tip and the real-time position information of the marker point on the blood vessel model to determine whether the difference is within a preset reasonable range.

3. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 2, characterized in that, The data analysis module is also used to compare the difference between the real-time position information of the needle tip of the puncture needle and the real-time position information of the marker point on the tumor model, and to determine whether the difference is within a preset reasonable range.

4. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 2, characterized in that, The organ simulation unit also includes a skin simulation layer; The skin simulation layer includes, from top to bottom, an epidermal simulation layer, a dermal simulation layer, and a subcutaneous tissue simulation layer; the subcutaneous tissue simulation layer covers the liver model.

5. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 4, characterized in that, The organ simulation unit also includes a constraint body; The constraint body encloses the liver model so that the liver model is located inside the constraint body; the constraint body is used to constrain the liver model; the subcutaneous tissue simulation layer covers the constraint body; the constraint body is made of transparent hydrogel.

6. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 5, characterized in that, The organ simulation unit includes a fixing box with an opening at the top; The side walls of the fixing box are made of transparent material; the bottom of the fixing box is fixed to the organ driving mechanism; the four sides of the restraint body are fixed to the side walls of the fixing box; the bottom of the restraint body is fixed to the bottom wall of the fixing box. A base layer is provided between the constraint body and the fixing box; The epidermal simulation layer, the dermal simulation layer, the subcutaneous tissue simulation layer, the restraint body, and the basal layer are all located within the fixation box; The base layer is made of non-transparent hydrogel.

7. The intelligent testing system for minimally invasive interventional surgical instruments according to claim 1, characterized in that, The monitoring module includes an XZ-direction camera, a YZ-direction camera, and a transmission module; The XZ-direction camera is used to acquire the initial X and Z-direction position information of the marker point, and the real-time X and Z-direction position information of the marker point and the puncture needle. The YZ-direction camera is used to collect the initial Y and Z-direction position information of the marker point, and the real-time Y and Z-direction position information of the marker point and the puncture needle; The transmission module is used to send the initial position information of the marker point, the real-time position information of the marker point and the puncture needle to the data analysis module.

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