Minimally invasive puncture system based on navigation system

Abstract

The present invention relates to a minimally invasive puncture system based on a navigation system, which includes a puncture instrument and an electromagnetic navigation module. The first electromagnetic positioning sensor in the electromagnetic navigation module is fixedly mounted on the puncture needle body in the puncture instrument, and the second electromagnetic positioning sensor is slidably mounted on the puncture needle body. The electromagnetic positioning reading device in the electromagnetic navigation module is used to obtain the real-time coordinates of the first and second electromagnetic positioning sensors to obtain the real-time motion trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor, and to determine whether the real-time needle insertion trajectory of the puncture needle body entering the human body conforms to the system's preset needle insertion trajectory. The system can effectively assist the operator in determining whether the puncture needle body can reach the lesion, and is easy to operate and effectively improves the accuracy of puncture instrument placement and surgical operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a minimally invasive puncture system based on a navigation system. Background Art

[0002] Ablation tools such as puncture and biopsy procedures offer minimal trauma, ease of control, and a short surgical procedure time. Because ablation devices are minimally invasive during ablation procedures, they are widely used clinically for thermal coagulation of tumor tissue in organs such as the liver, lungs, and kidneys. While technological advancements have led to increasingly precise and controllable ablation procedures, inherent limitations of the technology make it impossible to intuitively determine the relative position of the ablation device and the lesion. Consequently, precise determination and monitoring of the ablation range during use are impossible, hindering accurate placement of the puncture or biopsy tool within the target sampling area, thus impacting biopsy efficiency. Summary of the Invention

[0003] In view of the above-mentioned defects of the prior art, the present invention provides a minimally invasive puncture system based on a navigation system, which effectively assists the operator to intuitively determine whether the relative positions of the puncture device and the lesion effectively coincide, is easy to operate, improves ablation, and has high operating accuracy.

[0004] In order to achieve the above objectives, the minimally invasive puncture system based on the navigation system of the present invention has the following structure:

[0005] The main features of the minimally invasive puncture system based on the navigation system include:

[0006] A puncture instrument, comprising a handheld portion and a puncture needle body, wherein the puncture needle body is provided on the handheld portion;

[0007] An electromagnetic navigation module, comprising an electromagnetic positioning reading device, a first electromagnetic positioning sensor, and a second electromagnetic positioning sensor, wherein the first electromagnetic positioning sensor is fixedly disposed on the puncture needle body at a position adjacent to the handheld portion, and the second electromagnetic positioning sensor is slidably mounted on the puncture needle body, and the second electromagnetic positioning sensor is located on a side of the first electromagnetic positioning sensor away from the handheld portion;

[0008] The electromagnetic positioning reading device is used to obtain the real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor to obtain the real-time movement trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor, and to determine whether the real-time insertion trajectory of the puncture needle body entering the human body conforms to the system preset insertion trajectory.

[0009] The above-mentioned minimally invasive puncture system based on the navigation system, wherein the minimally invasive puncture system based on the navigation system further includes:

[0010] An ultrasonic imaging module, comprising an ultrasonic probe, configured to generate a real-time ultrasonic image based on detection information from the ultrasonic probe;

[0011] The electromagnetic navigation module further includes a third electromagnetic positioning sensor, which is arranged on the ultrasonic probe;

[0012] The electromagnetic positioning reading device is further used to obtain the real-time coordinates of the third electromagnetic positioning sensor, so as to determine the relative position relationship between the ultrasonic probe and the puncture needle body according to the real-time coordinates of the first electromagnetic positioning sensor, the second electromagnetic positioning sensor and the third electromagnetic positioning sensor;

[0013] an image fusion module for fusing the real-time insertion trajectory of the puncture needle body into the human body with the real-time ultrasonic image to generate a device navigation screen that fuses the relative spatial position of the puncture needle body with the real-time ultrasonic image;

[0014] The display module receives the device navigation screen generated by the image fusion module and displays the device navigation screen.

[0015] In the above-mentioned minimally invasive puncture system based on the navigation system, the device navigation screen also displays the system preset needle insertion trajectory of the puncture needle body entering the human body.

[0016] In the above-mentioned minimally invasive puncture system based on the navigation system, the image fusion module includes:

[0017] an ultrasonic image calibration unit, configured to establish a relative position and angle relationship between the real-time ultrasonic image and the third electromagnetic positioning sensor, and determine a mapping relationship between each pixel point in the real-time ultrasonic image and the third electromagnetic positioning sensor;

[0018] an ablation probe calibration unit, configured to construct a mapping relationship between the real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor and the real-time insertion trajectory of the puncture needle body;

[0019] The coordinate unification unit converts the coordinates of each pixel point in the real-time ultrasonic image and the real-time needle insertion trajectory of the puncture needle body into the reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module to generate the device navigation screen.

[0020] In the above-mentioned minimally invasive puncture system based on the navigation system, the image fusion module further includes:

[0021] The three-dimensional reconstruction unit is used to convert the two-dimensional image collected by the ultrasonic imaging module into a three-dimensional ultrasonic image.

[0022] In the above-mentioned minimally invasive puncture system based on the navigation system, the following operations are performed when the real-time needle insertion trajectory of the puncture needle body into the human body is fused with the real-time ultrasonic image to generate a device navigation screen that fuses the relative spatial position of the puncture needle body with the real-time ultrasonic image:

[0023] According to the obtained real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor, a real-time motion trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor is obtained to obtain the real-time insertion trajectory of the puncture needle body into the human body;

[0024] Determining a mapping relationship between a reference coordinate system formed by a magnetic field generator in the electromagnetic navigation module and the real-time ultrasonic image;

[0025] Determining a mapping relationship between a real-time insertion trajectory of the puncture needle body into the human body and the reference coordinate system;

[0026] According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system, a device navigation screen is generated that integrates the relative spatial position of the puncture needle body into the real-time ultrasonic image.

[0027] In the above-mentioned minimally invasive puncture system based on the navigation system, determining the mapping relationship between the reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module and the real-time ultrasonic image includes:

[0028] The coordinate system relationship of the ultrasound probe coordinate system where the third electromagnetic positioning sensor is located is converted and unified relative to the reference coordinate system to determine a mapping relationship between the reference coordinate system and the real-time ultrasonic image.

[0029] In the above-mentioned minimally invasive puncture system based on the navigation system, the step of determining the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system includes:

[0030] The coordinate systems of the puncture needle body where the first electromagnetic positioning sensor and the second electromagnetic positioning sensor are located are converted and unified relative to the reference coordinate system to determine the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system.

[0031] The above-mentioned minimally invasive puncture system based on the navigation system, wherein the device navigation screen that integrates the relative spatial position of the puncture needle body into the real-time ultrasonic image is generated based on the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system, includes:

[0032] According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system, the relative position relationship between the real-time ultrasonic image and the real-time needle insertion trajectory of the puncture needle body entering the human body in the reference coordinate system is determined, and then the device navigation screen that integrates the relative spatial position of the puncture needle body into the real-time ultrasonic image is generated.

[0033] In the above-mentioned minimally invasive puncture system based on the navigation system, the puncture instrument can be any one of a puncture device, an ablation device, and a biopsy tool.

[0034] Beneficial effects of the minimally invasive puncture system based on the navigation system of the present invention:

[0035] 1. Compared with puncture devices without navigation positioning sensors, during use of the minimally invasive puncture system based on the navigation system of the present invention, the spatial position of the needle tip of the puncture needle body can be inferred using the real-time positions obtained by the first electromagnetic positioning sensor and the second electromagnetic positioning sensor, and tracked and displayed, allowing the operator to adjust the puncture direction of the puncture instrument in real time according to the spatial position of the real-time needle insertion trajectory during use.

[0036] 2. In a minimally invasive puncture system based on a navigation system, two or more first electromagnetic positioning sensors are provided on the puncture needle body. One of the electromagnetic positioning sensors located at the end of the puncture needle body is designed to be fixed, and the coordinates of the fixed electromagnetic positioning sensor are used as the basic coordinates of the puncture needle body coordinate system. The other electromagnetic positioning sensors are designed to be slidable. During the puncture process, the slidable electromagnetic positioning sensor can move toward the fixed electromagnetic positioning sensor under the push of the skin. The electromagnetic navigation module can determine the relative position of the active electromagnetic positioning sensor on the puncture needle body based on the change in the relative position of the fixed electromagnetic positioning sensor and the active electromagnetic positioning sensor, and can determine whether the puncture needle body has been bent or deformed based on the relative movement trajectory of the multiple electromagnetic positioning sensors on the puncture needle body. Since the electromagnetic positioning sensor near the needle tip of the puncture needle body in this solution is designed to slide, it will not increase the thickness of the needle body when entering the human body. At the same time, for some puncture instruments that require high temperature operation, the high temperature at the needle tip will not affect the electromagnetic positioning sensor. This method can not only provide designers with more convenience, but also improve the accuracy of the system.

[0037] 3. The spatial position of the needle insertion trajectory of the puncture needle body is positioned and displayed through the display module. Before the puncture needle body is inserted into a solid organ, the spatial position of the needle tip of the puncture needle body can be obtained. During actual use, this spatial position can help the puncture needle body plan the entry point where the puncture needle body intersects with the surface of the organ (such as the liver).

[0038] 4. The reconstructed ultrasound image is displayed in real time on the monitor. In the real-time displayed image, the position of the puncture needle body is dynamically displayed on the screen. The dynamic image helps to adjust the puncture needle body in real time during actual use, ensuring that the electrode needle is accurately placed in the target ablation lesion area. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The concept, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings to fully understand the purpose, characteristics and effects of the present invention.

[0040] Figure 1 1 is a module relationship diagram of a minimally invasive puncture system based on a navigation system according to an embodiment of the present invention.

[0041] Figure 2 1 is a diagram showing the relative positions of the ablation probe, the ablation handle, the first electromagnetic positioning sensor, and the second electromagnetic positioning sensor according to an embodiment of the present invention.

[0042] Figure 3 FIG. 1 is a schematic diagram of the relative position of the second electromagnetic positioning sensor on the ablation probe in the first state according to an embodiment of the present invention.

[0043] Figure 4 FIG. 1 is a schematic diagram of the relative position of the second electromagnetic positioning sensor on the ablation probe in the second state according to an embodiment of the present invention.

[0044] Figure 5 Schematic diagram of the needle insertion state with human tissue.

[0045] Figure 6A Schematic diagram of a device navigation screen of a minimally invasive puncture system based on a navigation system according to an embodiment of the present invention.

[0046] Figure 6B Schematic diagram of a device navigation screen of a minimally invasive puncture system based on a navigation system according to another embodiment of the present invention.

[0047] Figure 7 It is a state diagram of the puncture needle body.

[0048] Figure 8 Schematic diagram of the scanning mapping relationship based on the N-line calibration block.

[0049] Reference numerals

[0050] 1 Handheld

[0051] 2. Puncture needle body

[0052] 3. First electromagnetic positioning sensor

[0053] 4 Second electromagnetic positioning sensor

[0054] 5 Real-time needle trajectory

[0055] 6 System preset needle trajectory

[0056] 7 Human epidermal tissue area

[0057] 8 Lesions

[0058] 9 Needle entry point DETAILED DESCRIPTION

[0059] In order to make the technical means, creative features, objectives and effects of the invention easier to understand, the invention is further described below with reference to specific diagrams. However, the invention is not limited to the following implementation cases.

[0060] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification so that people familiar with this technology can understand and read them. They are not used to limit the conditions under which the present invention can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in the present invention without affecting the efficacy and purpose that can be achieved by the present invention.

[0061] The following combination Figures 1 to 8 The present invention is further described, wherein: Figure 1 It only reflects the relationship between modules and their components, and does not limit the actual design location of each component:

[0062] The minimally invasive puncture system based on the navigation system in this embodiment includes:

[0063] The puncture instrument comprises a handheld portion 1 and a puncture needle body 2, wherein the puncture needle body 2 is provided on the handheld portion 1;

[0064] An ultrasonic imaging module, comprising an ultrasonic probe, configured to generate a real-time ultrasonic image based on detection information from the ultrasonic probe;

[0065] The electromagnetic navigation module includes an electromagnetic positioning reading device, a first electromagnetic positioning sensor 3, a second electromagnetic positioning sensor 4 and a third electromagnetic positioning sensor, wherein Figure 2 As shown, the first electromagnetic positioning sensor 3 is fixedly arranged on the puncture needle body 2 at a position adjacent to the handheld part 1, the second electromagnetic positioning sensor 4 is slidably sleeved on the puncture needle body 2, and the second electromagnetic positioning sensor 4 is located on the side of the first electromagnetic positioning sensor 3 away from the handheld part 1; the third electromagnetic positioning sensor is arranged on the ultrasonic probe;

[0066] The electromagnetic positioning reading device is used to obtain the real-time coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4, so as to obtain the real-time motion trajectory of the second electromagnetic positioning sensor 4 relative to the first electromagnetic positioning sensor 3, and to determine whether the real-time insertion trajectory 5 of the puncture needle body 2 entering the human body conforms to the system preset insertion trajectory 6;

[0067] The electromagnetic positioning reading device is further used to obtain the real-time coordinates of the third electromagnetic positioning sensor, so as to determine the relative position relationship between the ultrasonic probe and the puncture needle body 2 according to the real-time coordinates of the first electromagnetic positioning sensor 3, the second electromagnetic positioning sensor 4 and the third electromagnetic positioning sensor;

[0068] An image fusion module is used to fuse the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body with the real-time ultrasonic image to generate a device navigation screen that fuses the relative spatial position of the puncture needle body 2 with the real-time ultrasonic image;

[0069] The display module receives the device navigation screen generated by the image fusion module and displays the device navigation screen.

[0070] like Figure 3 and Figure 4 As shown, the second electromagnetic positioning sensor 4 can slide on the puncture needle body 2. During the actual operation, the second electromagnetic positioning sensor 4 can be set at Figure 3 As shown in the figure, that is, the position of the needle head close to the puncture needle body 2, as the puncture needle body 2 gradually enters the human body, the second electromagnetic positioning sensor 4 can slowly move closer to the first electromagnetic positioning sensor 3 under the push of the human epidermal tissue area 7, that is, as shown in the figure Figure 4 In the state shown, the electromagnetic navigation module captures the relative position of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 .

[0071] The electromagnetic navigation module can determine whether the second electromagnetic positioning sensor 4 moves along the preset trajectory (i.e., the trajectory formed by the puncture needle body 2 in a normal state, which is pre-stored in the system) toward the first electromagnetic positioning sensor 3 by detecting the coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4. If some puncture needle body 2 is deformed due to external force during the puncture process, the second electromagnetic positioning sensor 4 will not be able to move along the preset trajectory toward the first electromagnetic positioning sensor 3. Then the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body will not conform to the system preset needle insertion trajectory 6. At this time, it can be known that the puncture is abnormal ( Figure 7 is a schematic diagram of the state of the puncture needle body 2, wherein the solid line portion depicts the schematic diagram of the puncture needle body 2 in the normal state, and the dashed line portion depicts the outline of the puncture needle body 2 when it is bent. Alternatively, due to an incorrect operation by the operator, the puncture needle body 2 cannot puncture the lesion 8. In this case, the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body obtained based on the coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 still indicates that the needle tip of the puncture needle body 2 cannot reach the lesion 8 according to the current operation method.

[0072] In the present invention, the real-time positions of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 can be used to infer the spatial position of the needle tip of the puncture needle body 2 and track and display it, so that the operator can adjust the puncture direction of the puncture instrument in real time according to the spatial position of the real-time needle insertion trajectory 5 during use, effectively assisting the operator to perform precise operations.

[0073] During the actual operation, the prompt can be given by using the real-time display method of the screen in this embodiment, or by using the voice warning method. However, the voice warning method is less intuitive than the method of displaying the real-time needle insertion trajectory 5 on the screen.

[0074] In this embodiment, the relative spatial position of the puncture needle body 2 is also fused with the real-time ultrasonic image, so that the operator can more intuitively determine the relative position relationship between the needle insertion trajectory and the eight points of the lesion.

[0075] In this embodiment, the device navigation screen also displays the system preset needle insertion trajectory 6 of the puncture needle body 2 entering the human body.

[0076] Since the system preset needle insertion trajectory 6 is also displayed in the navigation screen, the operator can be better guided to perform the needle insertion operation.

[0077] It should be noted that, in practical operation, the real-time needle insertion trajectory 5 is not a line that coincides with the needle body, but a guide line that can predict the direction of the needle body's advancement. Figure 5 Schematic diagram of the needle insertion state with human tissue, as shown in Figure 5As shown, the lesion 8 is located in the liver of the human body, and the puncture needle body 2 (due to the size of the picture, Figure 5 Only a thick solid line is drawn to represent the puncture needle body 2, which does not limit the actual shape of the puncture needle body 2) is currently at the needle entry point 9 outside the human body. At this time, the real-time needle insertion trajectory 5 is formed by the dotted line extending from the needle entry point 9 to the lesion 8 in the figure. At this time, the screen seen by the operator in the display module can be referred to Figure 6A or Figure 6B shown.

[0078] Figure 6A and Figure 6B The following are two schematic diagrams of the device navigation screen of the minimally invasive puncture system based on the navigation system. Figure 6A The solid line is the system preset needle insertion track 6, and the dotted line is the real-time needle insertion track 5. It can be seen from the figure that the real-time needle insertion track 5 coincides with the system preset needle insertion track 6. At this time, it can be determined that the needle insertion direction is correct and the operator can perform the needle insertion operation normally. Figure 6B In the figure, the line on the left is the real-time needle insertion trajectory 5 (the solid line portion in the real-time needle insertion trajectory 5 represents the position of the puncture needle body 2, and the dotted line portion represents the position to be reached by the puncture needle body 2 if it continues to move forward along the current trajectory), and the line on the right is the system preset needle insertion trajectory 6. The operator can adjust the needle insertion direction and calibrate the operation according to the deviation between the real-time needle insertion trajectory 5 and the system preset needle insertion trajectory 6.

[0079] The real-time needle insertion trajectory 5 in the figure is a predicted needle insertion trajectory formed based on the coordinates of the current first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 and the relative position change relationship between the two. That is, it draws the preset needle insertion direction and position when the operator operates according to the current operation direction, so that the operator can judge whether to continue to perform the needle insertion operation according to the current needle insertion trajectory, or make adaptive adjustments.

[0080] The image fusion module includes:

[0081] an ultrasonic image calibration unit, configured to establish a relative position and angle relationship between the real-time ultrasonic image and the third electromagnetic positioning sensor, and determine a mapping relationship between each pixel point in the real-time ultrasonic image and the third electromagnetic positioning sensor;

[0082] an ablation probe calibration unit, configured to construct a mapping relationship between the real-time coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 and the real-time needle insertion trajectory 5 of the puncture needle body 2;

[0083] A coordinate unification unit converts the coordinates of each pixel point in the real-time ultrasonic image and the real-time needle insertion trajectory 5 of the puncture needle body 2 into a reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module to generate the device navigation screen;

[0084] The three-dimensional reconstruction unit is used to convert the two-dimensional image collected by the ultrasonic imaging module into a three-dimensional ultrasonic image.

[0085] The following operations are performed when the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body is fused with the real-time ultrasonic image to generate a device navigation screen in which the relative spatial position of the puncture needle body 2 is fused with the real-time ultrasonic image:

[0086] According to the obtained real-time coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4, the real-time motion trajectory of the second electromagnetic positioning sensor 4 relative to the first electromagnetic positioning sensor 3 is obtained to obtain the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body;

[0087] Determining a mapping relationship between a reference coordinate system formed by a magnetic field generator in the electromagnetic navigation module and the real-time ultrasonic image specifically includes:

[0088] The coordinate system of the ultrasound probe in which the third electromagnetic positioning sensor is located is converted and unified relative to the reference coordinate system to determine a mapping relationship between the reference coordinate system and the real-time ultrasound image (in implementation, the relative position of each pixel point in the ultrasound image and the coordinate point of the third electromagnetic positioning sensor can be fixed, and then, after the relationship between the coordinate point of the third electromagnetic positioning sensor and the reference coordinate system is determined, the mapping relationship between each pixel point in the ultrasound image and the reference coordinate system can be determined);

[0089] Determining the mapping relationship between the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body and the reference coordinate system specifically includes:

[0090] The coordinate system relationship of the puncture needle body coordinate system where the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 are located is converted and unified relative to the reference coordinate system to determine the mapping relationship between the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body and the reference coordinate system (in the implementation process, the coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 can be matched with the contour relationship of the puncture needle body 2, so that the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body can be determined according to the coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 and the movement trajectory of the second electromagnetic positioning sensor 4 relative to the first electromagnetic positioning sensor 3. After mapping the coordinates of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 to the reference coordinate system, the mapping relationship between the real-time needle insertion trajectory 5 and the reference coordinate system can be determined);

[0091] According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body and the reference coordinate system, generating the device navigation screen that integrates the relative spatial position of the puncture needle body 2 with the real-time ultrasonic image specifically includes:

[0092] According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body and the reference coordinate system, the relative position relationship between the real-time ultrasonic image and the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body in the reference coordinate system is determined, and then the device navigation screen that integrates the relative spatial position of the puncture needle body 2 into the real-time ultrasonic image is generated.

[0093] That is, in the process of generating the above-mentioned device navigation screen, the electromagnetic navigation module converts and unifies the coordinate system relationship of the puncture needle body coordinate system where the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 are located and the ultrasound probe coordinate system where the third electromagnetic positioning sensor is located relative to the reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module, so as to unify the coordinates of the first electromagnetic positioning sensor 3, the second electromagnetic positioning sensor 4 and the third electromagnetic positioning sensor into the same coordinate system, and then determines the relative coordinate relationship between the first electromagnetic positioning sensor 3, the second electromagnetic positioning sensor 4 and the third electromagnetic positioning sensor in the unified coordinate system, and then determines the relative position relationship between the ultrasound probe and the puncture needle body 2, and then presents the real-time needle insertion trajectory 5 of the puncture needle body 2 entering the human body and the real-time ultrasonic image in the same screen.

[0094] In the mapping process of each coordinate, the coordinates (x1, y1, z1) of the first electromagnetic positioning sensor 3 in the puncture needle body coordinate system can be used as the reference coordinates of the puncture needle body coordinate system, and the coordinates (x2, y2, z2) of the third electromagnetic positioning sensor in the ultrasound probe coordinate system can be used as the reference coordinates of the ultrasound probe coordinate system. The coordinate relationship between the puncture needle body coordinate system and the ultrasound probe coordinate system is converted and unified relative to the reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module, and the coordinates (x1, y1, z1) of the first electromagnetic positioning sensor 3 and the coordinates (x2, y2, z2) of the third electromagnetic positioning sensor are determined to be relative to the reference coordinate system. The relative position relationship of the reference coordinates (x, y, z) in the image is obtained, and then through the conversion relationship of the above coordinate systems, the relative positions between the various coordinate systems can be clearly understood (the specific coordinate conversion method adopted in this embodiment can be converted using the unified coordinate conversion method in the prior art). In this embodiment, since a third electromagnetic positioning sensor is provided on the ultrasonic probe, the third electromagnetic positioning sensor can be used to obtain the spatial coordinates of the points on the ultrasonic image, so that the ultrasonic image can be displayed in the electromagnetic positioning sensor, and then the relative position relationship of the puncture needle body 2, the real-time needle insertion trajectory 5 and the real-time ultrasonic image can be determined in the same picture.

[0095] During implementation, two or more first electromagnetic positioning sensors 3 are provided on the puncture needle body 2, one of which is located at the end of the puncture needle body 2 and is designed to be fixed. The coordinates of the fixed electromagnetic positioning sensor are used as the basic coordinates of the puncture needle body coordinate system, and the other electromagnetic positioning sensors are designed to be slidable. During the puncture process, the slidable electromagnetic positioning sensor can move toward the fixed electromagnetic positioning sensor under the push of the skin. The electromagnetic navigation module can determine the relative position of the active electromagnetic positioning sensor on the puncture needle body 2 based on the change in the relative position of the fixed electromagnetic positioning sensor and the active electromagnetic positioning sensor, and can determine whether the puncture needle body 2 has been bent or deformed based on the relative movement trajectory of the multiple electromagnetic positioning sensors on the puncture needle body 2. Since the electromagnetic positioning sensor near the needle tip of the puncture needle body 2 in this solution is designed to slide, it will not increase the thickness of the needle body when entering the human body. At the same time, for some puncture instruments that require high temperature operation, the high temperature at the needle tip will not affect the electromagnetic positioning sensor. This method can not only provide designers with more convenience, but also improve the accuracy of the system.

[0096] The puncture instrument in the above embodiment may be any one of a puncture device, an ablation device, and a biopsy tool.

[0097] When the puncture instrument is the ablation device, the puncture instrument further comprises an ablation host, wherein the handheld portion 1 is formed by an ablation handle, and the puncture needle body 2 is formed by an ablation probe;

[0098] The ablation handle is connected to the ablation host;

[0099] The ablation host interacts with the electromagnetic navigation module, the ultrasonic imaging module and the image fusion module.

[0100] During use, the relative positions of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 on the ablation probe are detected to determine the position and posture of the ablation probe, thereby generating a real-time needle insertion trajectory 5. This real-time needle insertion trajectory 5 is then fused with the real-time ultrasound image and displayed on the device's navigation screen. This navigation-based minimally invasive puncture system effectively assists the operator in visually observing the relative position of the instrument being operated and the lesion, is easy to operate, and effectively improves the accuracy of instrument puncture placement and the accuracy of biopsy or ablation.

[0101] The system combines electromagnetic navigation technology with ultrasound image reconstruction. Through ultrasound image construction, the spatial position of the ablation probe electrode and the target tumor is displayed in real time in the constructed ultrasound reconstructed image. This real-time display helps the operator intuitively understand the relative spatial position of the ablation electrode, the target surgical organ, and adjacent organs, thereby effectively improving surgical precision and achieving precise placement of the ablation electrode in the target ablation area under navigation guidance (this technical solution can also achieve corresponding technical effects when applied to other puncture, biopsy, and other procedures). At the same time, the system is equipped with two electromagnetic positioning sensors, leaving more design space for product implementation.

[0102] In the design and process implementation of the existing technology, the sensor usually cannot be placed at the tip of the ablation probe, but can only be placed near the handle. During use, the electrode needle may be deformed during the puncture process, and the deformation will cause human errors. If the error beyond the allowable range is not discovered in time, it will cause a large deviation in the puncture.

[0103] Therefore, in order to solve the above problems, the present invention is designed to have at least two electromagnetic positioning sensors arranged on the electrode needle (for example, in some embodiments, three electromagnetic positioning sensors can also be arranged on the electrode needle). The added slidable electromagnetic positioning sensor can be placed near the tip of the electrode needle and can be moved during use. At the beginning of use, when puncture is just started, the electromagnetic positioning sensor can be placed near the tip of the needle. The system reads the position of this place and calculates the position of the needle tip (because it is close to the needle tip, the calculated needle tip position is more accurate). At the same time, through the relative position with the sensor near the handle, it can be calculated whether the electrode needle is bent during use, generate a corresponding real-time needle insertion trajectory 5, and remind the user (the display method of the real-time needle insertion trajectory 5 can be referred to). Figure 6A and Figure 6B As shown), adjust the electrode needle to a relatively straight state and perform puncture. In this way, the added sliding electromagnetic positioning sensor allows the system to take into account both ease of use and navigation accuracy.

[0104] The core of the navigation system is to obtain spatial information corresponding to ultrasound images and ablation / biopsy tools, thereby providing surgical guidance to doctors within the system software interface. During implementation, based on the electromagnetic navigation module, it is necessary to determine the mapping relationship between the ultrasound image and the electromagnetic navigation system, as well as the mapping relationship between the position and posture of the ablation (puncture, biopsy) tool and the electromagnetic navigation system. In this invention, a calibration process is used to obtain the corresponding coordinate system transformation matrix.

[0105] The following combination Figure 8 The image processing principle in the above embodiment is further explained:

[0106] In this embodiment, the image fusion module includes:

[0107] An ultrasonic image calibration unit, configured to establish a relative position and angle relationship between the real-time ultrasonic image and the electromagnetic positioning sensor, and determine a mapping relationship between each pixel point in the real-time ultrasonic image and the electromagnetic positioning sensor;

[0108] Combine Figure 8 As shown (where Figure 8 The leftmost figure shows the N-line calibration block. Figure 8 The middle picture shows the scanning diagram. Figure 8 The rightmost figure in the figure shows the actual scanning effect). In specific implementation, a calibration block is used, such as the common N-line calibration block. Through the geometric relationship of similar triangles, Figure 8 The positions of points A and B on the graph determine the actual physical position of the middle point C, thereby establishing the following equation 1 as the constraint equation:

[0109]

[0110] Among them, T s→g represents the transformation matrix from the coordinate system of each electromagnetic positioning sensor to the coordinate system of the magnetic field generator (i.e., the reference coordinate system), T g→w Represents the transformation matrix from the magnetic field generator coordinate system to the world coordinate system defined by the N-line calibration block. and Represent the homogeneous coordinate representation of point C in the image coordinate system and the world coordinate system respectively. Establish multiple constraint equations by scanning the images obtained at different positions and directions. Apply iterative optimization algorithms, such as solving the transformation matrix T i→s , thereby establishing a mapping relationship between each pixel point on the ultrasound image and the third electromagnetic positioning sensor.

[0111] an ablation probe calibration unit, configured to establish the relative position and offset between the needle tip position and posture of the ablation probe (i.e., the real-time needle insertion trajectory 5) and the two electromagnetic positioning sensors;

[0112] During implementation, the position and posture of each electromagnetic positioning sensor in the magnetic field generator coordinate system are known. By placing the puncture needle body 2 parallel to each electromagnetic positioning sensor, the posture of each electromagnetic positioning sensor can be consistent with the puncture needle body 2. The translation amount is obtained by calibration. The calibration method is as follows: the translation matrix from the puncture needle body 2 coordinate system (tip) to the electromagnetic positioning sensor is T t→s , the homogeneous coordinates of a point in space in two coordinate systems are x t =[x t ,y t , z t , 1] T and x s =[x s ,y s , z s , 1] T , then x s =T t→s x t By using the calibration tool of the electromagnetic positioning system, the translation matrix T is calculated t→s .

[0113] Two or more electromagnetic positioning sensors are placed on the puncture needle body 2 for accurate positioning while facilitating operation by the operator. For ease of explanation, the following uses the working mode of two electromagnetic positioning sensors as an example. The spatial conversion relationship in the algorithm is:

[0114] The first electromagnetic positioning sensor 3 is a fixed sensor. The position transformation relationship between the needle tip position and the first electromagnetic positioning sensor 3 is determined by the mapping relationship mentioned above. The second electromagnetic positioning sensor 4 is a micro-sliding sensor. The movement direction of the second electromagnetic positioning sensor 4 is used as a basis for judging whether the needle tip of the puncture needle body 2 is bent. The direction vectors of the first electromagnetic positioning sensor 3 and the second electromagnetic positioning sensor 4 are respectively and Then when satisfied When , it means that the tip does not produce a curvature that exceeds the preset standard, where ε is 0.01; when it does not meet When the needle tip is bent beyond the preset standard, the system stops guiding and prompting, and resumes guiding and prompting when the needle tip returns to the correct position.

[0115] During use, the position of the second electromagnetic positioning sensor 4 is not fixed. After the puncture needle body 2 enters the human body, it moves toward the handheld part 1. During use, the position of the first electromagnetic positioning sensor 3 is fixed. It is placed on the puncture needle body 2 at a position adjacent to the handheld part 1, or can be directly set inside the handle. During use, the first electromagnetic positioning sensor 3 will not move. During use, the position of the sensor changes as shown in the figure. Figure 3 and Figure 4 shown.

[0116] By capturing the trajectory of the second electromagnetic positioning sensor 4 sliding on the puncture needle body 2, the real-time motion trajectory of the puncture needle body 2 can be obtained. This real-time motion trajectory is compared with the trajectory of the ideal electrode needle in an unbent state (i.e., the system-preset needle insertion trajectory 6). This allows for real-time operation reminders and adjustment of the puncture needle body 2 for precise insertion.

[0117] By comparing the coordinate positions of the second electromagnetic positioning sensor 4 with the first electromagnetic positioning sensor 3, the distance between the first and second electromagnetic positioning sensors 3 and 4 can be calculated. This allows the distance between the second electromagnetic positioning sensor 4 and the needle tip to be calculated, and the needle insertion depth to be inferred. When the puncture needle body 2 first contacts the skin for puncture, the second electromagnetic positioning sensor 4 is close to the needle tip. The spatial location of the second electromagnetic positioning sensor 4, close to the needle tip, can be used as the puncture location point. This location is typically more accurate than the second sensor's position during actual use.

[0118] Specifically, during implementation, the ultrasound image is first converted to an electromagnetic positioning coordinate system (i.e., a reference coordinate system). Multiple electromagnetic positioning sensors on the puncture needle body 2 are then converted to the electromagnetic positioning coordinate system. A three-dimensional ultrasound image of the scanned object is then reconstructed in the electromagnetic positioning coordinate system. In the above steps, the pixels of the two-dimensional or three-dimensional ultrasound image and the pixels of the image of the puncture needle body 2 are unified in the electromagnetic positioning coordinate system. The relative positional relationship between the puncture needle body 2 and the two-dimensional ultrasound plane image, as well as the position of the current two-dimensional ultrasound plane in the reconstructed three-dimensional ultrasound image, can be calculated in this coordinate system.

[0119] Conventional intraoperative ultrasound presents a two-dimensional section, which is limited to the overall presentation of the scanned part. With the help of the position of each frame of the ultrasound image calibrated in the above processing process, three-dimensional reconstruction is performed through interpolation calculation. After scanning the target object, a specific three-dimensional reconstruction method based on pixels, voxels, or functions can be used, and multi-threading or GPU parallel fast calculation can be used to achieve fast (real-time) and accurate three-dimensional reconstruction of the target. The specific reconstruction process can be directly processed by relevant software in the existing technology and will not be described in more detail in this application.

[0120] For intraoperative ultrasound used under laparoscopy, a traditional segmentation algorithm can be used to segment the target area and then perform three-dimensional reconstruction in the above steps, thereby providing more accurate target reconstruction.

[0121] The above-mentioned coordinate conversion process and relative distance calculation can be implemented using existing coordinate conversion software and coordinate calculation software in the prior art. The present invention uses relevant algorithms to execute the operating logic of the minimally invasive puncture system based on the navigation system, so the specific algorithm and coordinate conversion relationship are not further explained in this application.

[0122] Applying the above scheme to the ablation process, the specific ultrasound image algorithm processing process can be as follows:

[0123] 1. Use multi-threading or GPU parallel fast computing to achieve fast (real-time) and accurate puncture.

[0124] 2. With the help of the calibrated ultrasound image position, the two-dimensional ultrasound image and three-dimensional volume data are configured, the mapping relationship between the ultrasound image and the three-dimensional volume data is established, and the target detection and tracking network is used to determine the relative position of the ablation target and the ablation needle.

[0125] 3. The relative spatial position of the electrode needle at the lesion and the needle insertion path.

[0126] like Figure 6A and Figure 6B As shown in the figure, the image on the left is the original real-time ultrasound image, and the image on the right is the generated device navigation screen, in which the real-time needle insertion trajectory and the system preset needle insertion trajectory 6 are drawn respectively. The operator can adjust the ablation probe position according to the picture to better achieve ablation.

[0127] Beneficial effects of the minimally invasive puncture system based on the navigation system of the present invention:

[0128] 1. Compared with puncture devices without navigation positioning sensors, the spatial position of the needle tip of the puncture needle body can be tracked and displayed in real time during use, allowing the operator to adjust the puncture direction of the puncture needle body in real time according to the spatial position of the puncture needle body during use.

[0129] 2. Two or more electromagnetic positioning sensors are placed on the puncture needle body. One of the electromagnetic positioning sensors is designed to be fixed and serves as the basic coordinate of the puncture needle body. The other electromagnetic positioning sensors use algorithms to obtain their relative positions on the puncture needle body. This approach not only provides greater convenience for designers, but also improves system accuracy.

[0130] 3. The spatial position of the puncture needle body in the puncture instrument is displayed through electromagnetic navigation positioning. Before the puncture needle body is inserted into a solid organ, the spatial position of the needle tip of the puncture needle body can be obtained. During actual use, this spatial position can help the puncture needle body plan the insertion point where the puncture needle body intersects the tracheal surface.

[0131] 4. The reconstructed ultrasound image is displayed in real time on the monitor. In the real-time displayed image, the position of the puncture needle body is dynamically displayed on the screen. The dynamic image helps to adjust the puncture needle body in real time during actual use, ensuring that the puncture needle body is accurately placed in the target ablation lesion area.

[0132] The preferred embodiments of the present invention have been described in detail above. It should be understood that numerous modifications and variations based on the concepts of the present invention are possible without inventive effort by those skilled in the art. Therefore, any technical solution that can be derived by one skilled in the art through logical analysis, reasoning, or limited experimentation based on the concepts of the present invention and the prior art should be within the scope of protection defined by the claims.

Claims

1. A minimally invasive puncture system based on a navigation system, characterized in that: include: A puncture instrument, comprising a handheld portion and a puncture needle body, wherein the puncture needle body is provided on the handheld portion; An electromagnetic navigation module, comprising an electromagnetic positioning reading device, a first electromagnetic positioning sensor, a second electromagnetic positioning sensor, and a third electromagnetic positioning sensor, wherein the first electromagnetic positioning sensor is fixedly disposed on the puncture needle body at a position adjacent to the handheld portion, the second electromagnetic positioning sensor is slidably mounted on the puncture needle body, and the second electromagnetic positioning sensor is located on a side of the first electromagnetic positioning sensor away from the handheld portion; An ultrasonic imaging module, comprising an ultrasonic probe, configured to generate a real-time ultrasonic image based on detection information from the ultrasonic probe; The third electromagnetic positioning sensor is arranged on the ultrasonic probe; The electromagnetic positioning reading device is used to obtain the real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor, so as to obtain the real-time motion trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor, and to determine whether the real-time insertion trajectory of the puncture needle body into the human body conforms to the system preset insertion trajectory; the electromagnetic positioning reading device is also used to obtain the real-time coordinates of the third electromagnetic positioning sensor, so as to determine the relative position relationship between the ultrasonic probe and the puncture needle body according to the real-time coordinates of the first electromagnetic positioning sensor, the second electromagnetic positioning sensor and the third electromagnetic positioning sensor; an image fusion module for fusing the real-time insertion trajectory of the puncture needle body into the human body with the real-time ultrasonic image to generate a device navigation screen that fuses the relative spatial position of the puncture needle body with the real-time ultrasonic image; The display module receives the device navigation screen generated by the image fusion module and displays the device navigation screen; the device navigation screen also displays the system preset needle insertion trajectory of the puncture needle body entering the human body.

2. The minimally invasive puncture system based on the navigation system according to claim 1, characterized in that: The image fusion module includes: an ultrasonic image calibration unit, configured to establish a relative position and angle relationship between the real-time ultrasonic image and the third electromagnetic positioning sensor, and determine a mapping relationship between each pixel point in the real-time ultrasonic image and the third electromagnetic positioning sensor; an ablation probe calibration unit, configured to construct a mapping relationship between the real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor and the real-time insertion trajectory of the puncture needle body; The coordinate unification unit converts the coordinates of each pixel point in the real-time ultrasonic image and the real-time needle insertion trajectory of the puncture needle body into the reference coordinate system formed by the magnetic field generator in the electromagnetic navigation module to generate the device navigation screen.

3. The minimally invasive puncture system based on the navigation system according to claim 2, characterized in that: The image fusion module also includes: The three-dimensional reconstruction unit is used to convert the two-dimensional image collected by the ultrasonic imaging module into a three-dimensional ultrasonic image.

4. The minimally invasive puncture system based on the navigation system according to claim 1, characterized in that: When fusing the real-time insertion trajectory of the puncture needle body into the human body with the real-time ultrasonic image to generate a device navigation screen that fuses the relative spatial position of the puncture needle body with the real-time ultrasonic image, the following operations are performed: According to the obtained real-time coordinates of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor, a real-time motion trajectory of the second electromagnetic positioning sensor relative to the first electromagnetic positioning sensor is obtained to obtain the real-time insertion trajectory of the puncture needle body into the human body; Determining a mapping relationship between a reference coordinate system formed by a magnetic field generator in the electromagnetic navigation module and the real-time ultrasonic image; Determining a mapping relationship between a real-time insertion trajectory of the puncture needle body into the human body and the reference coordinate system; According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system, a device navigation screen is generated that integrates the relative spatial position of the puncture needle body into the real-time ultrasonic image.

5. The minimally invasive puncture system based on the navigation system according to claim 4, characterized in that: Determining a mapping relationship between a reference coordinate system formed by a magnetic field generator in the electromagnetic navigation module and the real-time ultrasonic image includes: The coordinate system relationship of the ultrasound probe coordinate system where the third electromagnetic positioning sensor is located is converted and unified relative to the reference coordinate system to determine a mapping relationship between the reference coordinate system and the real-time ultrasonic image.

6. The minimally invasive puncture system based on the navigation system according to claim 4, characterized in that: Determining the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system includes: The coordinate systems of the puncture needle body where the first electromagnetic positioning sensor and the second electromagnetic positioning sensor are located are converted and unified relative to the reference coordinate system to determine the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system.

7. The minimally invasive puncture system based on the navigation system according to claim 4, characterized in that: The generating of the device navigation screen that fuses the relative spatial position of the puncture needle body into the real-time ultrasonic image according to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body into the human body and the reference coordinate system includes: According to the mapping relationship between the reference coordinate system and the real-time ultrasonic image and the mapping relationship between the real-time needle insertion trajectory of the puncture needle body entering the human body and the reference coordinate system, the relative position relationship between the real-time ultrasonic image and the real-time needle insertion trajectory of the puncture needle body entering the human body in the reference coordinate system is determined, and then the device navigation screen that integrates the relative spatial position of the puncture needle body into the real-time ultrasonic image is generated.

8. The minimally invasive puncture system based on the navigation system according to claim 1, characterized in that: The puncture instrument may be any one of a puncture device, an ablation device, and a biopsy tool.

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