Intelligent puncture navigation system and method

Through the combination of medical imaging equipment and intelligent puncture needles, automatic navigation without image registration is achieved, error problems in existing systems are solved, accuracy and efficiency of puncture are improved, and cost is reduced.

WO2025139052A1PCT designated stage expired Publication Date: 2025-07-03JIANGSU CHUNCI MEDICAL TREATMENT TECHNOLOGY CO LTD
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Patent Information

Application Number
PCT/CN2024/117954
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-12-28
Filing Date
2024-09-10
Publication Date
2025-07-03

AI Technical Summary

Technical Problem

The existing puncture surgical navigation systems are prone to errors during image registration, resulting in puncture offset or failure, and the use of robotic arms is inflexible, expensive, and difficult to popularize.

Method used

Medical imaging equipment is used to obtain three-dimensional scanning images, mark the puncture points on the skin surface through positioning devices, and use intelligent puncture needles to monitor angle information in real time, real-time realization of automatic registration and real-time navigation, reducing dependence on the robotic arm.

Benefits of technology

It improves the accuracy and efficiency of puncture, reduces system costs, and avoids deviations caused by image registration errors. The puncture needle can be flexibly adjusted to adapt to human movement and reduces the risk of surgery.

✦ Generated by Eureka AI based on patent content.

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    Figure CN2024117954_03072025_PF_FP_ABST
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Abstract

Provided is an intelligent puncture navigation system and method. The system comprises a medical imaging device (1), an upper computer (2), a positioning device (3), and an intelligent puncture needle (4). The medical imaging device (1) is configured to acquire a three-dimensional scanning image of tissues to be punctured; the upper computer (2) is configured to determine puncture information according to the three-dimensional scanning image; the positioning device (3) is configured to form a mark on the skin surface of the area to be punctured according to the puncture information; the intelligent puncture needle (4) is configured to perform puncturing according to the mark and the puncture information and acquire real-time angle information of the puncture needle; the upper computer (2) is further configured to monitor the intelligent puncture needle (4) according to the real-time angle information. The intelligent puncture navigation system and method can achieve the navigation function without image registration, thereby avoiding puncture deviation or failure caused by image registration errors. The system and method offer flexible use and improve the puncture efficiency and accuracy.
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Description

Intelligent puncture navigation system and method

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 28, 2023, with application number 202311824637.8 and invention name “An Intelligent Puncture Navigation System”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of medical surgical navigation, and specifically to an intelligent puncture navigation system and method. Background Art

[0003] When biopsy or treatment of internal lesions requires puncture, a CT scanner is typically used to determine the lesion's position relative to a skin marker and the depth of the puncture needle. Specifically, the CT scanner first locates the lesion on a cross-section of the body. The optimal needle insertion position and angle are then selected within that plane. The precise location of the lesion and the puncture needle are determined using a three-dimensional image of the plane, angle, and depth. Although CT scanners can accurately determine the three-dimensional needle insertion angle and depth, the puncture procedure is performed after the patient is removed from the CT scanning plane. Once the patient is out of the CT scanner, the physician must use their own judgment to determine a rough needle insertion direction, perform the puncture, and then perform a CT scan for confirmation. Due to numerous human factors, inaccurate needle insertion often affects the accuracy of treatment. Sometimes, multiple needle insertions are necessary, which can lead to mispunctures in severe cases, causing significant pain and risk to the patient.

[0004] To address these issues, puncture surgical navigation systems have emerged. These systems consist of a stereotactic positioning system that reconstructs 3D images and a robotic arm. The operator manipulates the robotic arm based on the original image data stored on the monitor, while the monitor displays the puncture needle path, improving puncture accuracy and safety. Depending on the positioning method, puncture surgical navigation systems for certain scenarios are divided into two types: optical navigation systems and magnetic navigation systems. Both systems cannot display the angle of the puncture needle; they can only determine the angle of the robotic arm, which is then used to estimate the needle angle. These systems cannot display the needle angle in real time. During the puncture process, changes in the patient's position can also affect puncture accuracy. While the robotic arm can guide the puncture direction and ensure that the puncture angle does not shift, adjustment is very inflexible. During puncture, the patient is generally required to remain still, but the human body is not completely static. The intestines, lungs, and trachea are constantly moving, so the puncture angle often needs to be adjusted. When the puncture needle has partially entered the body, adjusting the puncture angle is not a simple matter of changing from one angle to another. Due to factors such as muscle grip, needle deformation, and rigidity, if a 15-degree adjustment is needed, the needle may need to be pushed down or up 30 or even 50 degrees before it can be adjusted 15 degrees when the needle naturally rebounds. Therefore, using the aforementioned robotic arm, which can only guide a fixed puncture direction, to guide the puncture is inconvenient and cannot be adjusted in real time as needed. Furthermore, current puncture surgical navigation systems are expensive and difficult to popularize.

[0005] Summary of the Invention

[0006] The purpose of this application is to provide an intelligent puncture navigation system and method, which realizes the functions of intelligent navigation and active guidance of puncture, avoids puncture deviation or failure caused by image registration errors, and is flexible to use, thereby improving the efficiency and accuracy of puncture.

[0007] To achieve the above objectives, the present invention provides the following technical solutions:

[0008] An intelligent puncture navigation system may include a medical imaging device (1), a host computer (2), a positioning device (3), and an intelligent puncture needle (4). The medical imaging device (1) is used to obtain a three-dimensional scanning image of a tissue to be punctured; the medical imaging device (1) may be a CT or magnetic resonance imaging device. The host computer (2) is used to determine puncture information based on the three-dimensional scanning image, wherein the puncture information may include the puncture point position, puncture angle, and needle insertion depth. The positioning device (3) is used to form a mark on the skin surface of the part to be punctured according to the puncture information; the mark may be the position of the point. The intelligent puncture needle (4) is used to perform puncture according to the mark and the puncture information, and obtain real-time angle information of the intelligent puncture needle (4). The host computer (2) may also be used to monitor the intelligent puncture needle (4) based on the real-time angle information. The positioning device (3), the intelligent puncture needle (4), and the medical imaging device (1) share a coordinate system. The positioning device (3) may include a first track (31) and a second track (32), wherein the first track (31) and the second track (32) are arranged directly above the scanning bed (11) of the medical imaging device (1), wherein the first track (31) is arranged parallel to the longitudinal direction of the scanning bed (11), and the second track (32) is arranged perpendicular to the first track (31) and is arranged on the first track (31), and can slide along the first track (31) under the drive of the first track (31); a laser emitter (33) is arranged on the lower side of the second track (32) facing the scanning bed (11), and the laser emitter (33) can move along the second track (32) under the drive of the second track (32). The positioning device (3) may also include a microcontroller and a wireless communication module, wherein the wireless communication module and the laser emitter (33) are electrically connected to the microcontroller respectively, and the microcontroller is also used to control the movement of the first track (31) and the second track (32). The host computer (2) communicates wirelessly with the microcontroller and sends coordinate information to the microcontroller. The microcontroller controls the movement of the first track (31) and the second track (32) according to the coordinate information of the puncture point, and adjusts the laser emitter (33) to the coordinate position. At this time, the microcontroller controls the laser emitter (33) to emit laser light, and the laser light hits the human body, which is the puncture point position.The intelligent puncture needle (4) may include a sleeve (43), which is detachably mounted on the outside of the needle sleeve (412) of the puncture needle (41), and a flexible circuit board is arranged inside the side wall of the sleeve (43) along its length direction, and at least two laser receivers (431) are arranged on the flexible circuit board. Corresponding to the laser receivers (431), a hole is arranged on the sleeve (43), and a second pogopin connector (432) is arranged at the end of the sleeve (43), and the second pogopin connector (432) is electrically connected to the flexible circuit board. A second pogopin connector (427) is arranged on the lower side of the corresponding shell (42), and the second pogopin connector (427) is electrically connected to the circuit board. The medical imaging device (1) emits a laser at a set zero point position, and the laser receiver (431) on the intelligent puncture needle (4) picks up the laser. When the two laser receivers (431) located on the same straight line both pick up the laser, the position is set as the zero point of the puncture needle. After the intelligent puncture needle (4) is powered on, the second pogopin connector (432) and the second pogopin connector (427) are powered on for communication. When the laser receiver (431) receives the laser signal, the information is transmitted to the host computer (2) via a Bluetooth module. When the host computer (2) receives the signals transmitted by the two laser receivers (431) at the same time, the position of the puncture needle (41) at this time is set to the zero point position, thereby achieving automatic alignment with the medical imaging device (1). The intelligent puncture navigation system may further include a puncture needle fixing device (5), the puncture needle fixing device (5) may include a silicone fixing plate (51), an adjusting device (52) and a hook (53); the adjusting device (52) may include an adjusting rope (521) and an adjusting buckle, the adjusting buckle may include a buckle body (522), one end of the adjusting rope (521) is fixedly connected to the buckle body (522), passes through the buckle body (522) and is connected to the silicone fixing plate (51), the other end of the adjusting rope (521) passes through the buckle body (522) and is adjustably connected to the buckle body (522), and one end of the hook (53) is slidably connected to the bend of the adjusting rope (521). The silicone fixing plate (51) supports the puncture needle (41) by its own gravity and friction with the skin. The hook (53) is used to hook the puncture needle (41). The hook (53) and the silicone fixing plate (51) are connected via an adjusting device (52). On the one hand, it is used to adjust the distance between the hook (53) and the silicone fixing plate (51), and on the other hand, it is used to support the hook (53) and adjust the fixing angle of the puncture needle (41).

[0009] An intelligent puncture navigation method, applied to the intelligent puncture navigation system, comprises: establishing an OC coordinate system based on a medical imaging device; establishing an OL coordinate system based on a positioning device; wherein the OC coordinate system and the OL coordinate system have the same x-axis and z-axis directions. Determining a mapping relationship between the OC coordinate system and the OL coordinate system. Using the medical imaging device to obtain a three-dimensional scan image of the tissue to be punctured. Using a host computer to determine puncture information based on the three-dimensional scan image, wherein the puncture information includes puncture point location, puncture angle, and needle insertion depth. Establishing an OP coordinate system based on the location of the tissue to be punctured, and determining a mapping relationship between the OP coordinate system and the OC coordinate system; wherein the coordinate origin of the OP coordinate system is located at the needle insertion point; the needle insertion point is the location where the positioning device marks the skin surface of the tissue to be punctured based on the puncture information. Based on the mapping relationships between the OL coordinate system and the OC coordinate system and the mapping relationship between the OP coordinate system and the OC coordinate system, determining a mapping relationship between the OP coordinate system and the OL coordinate system. An OU coordinate system is established based on the position of the tissue to be punctured in the virtual space, and a mapping relationship between the OC coordinate system and the OU coordinate system is determined; wherein the coordinate origin of the OU coordinate system is the position of the needle insertion point on the tissue to be punctured in the virtual space. A one-dimensional ON coordinate system is established based on the intelligent puncture needle; wherein the coordinate origin of the one-dimensional ON coordinate system is the position of the needle tip of the puncture needle. In the virtual space, a puncture process is simulated based on the puncture information to determine the virtual puncture needle tip position of the puncture needle. Real-time angle information is determined based on the virtual puncture needle tip position of the puncture needle. Puncture of the intelligent puncture needle is guided based on the real-time angle information.

[0010] According to the specific embodiments provided by this application, the application discloses the following technical effects: the intelligent puncture navigation system of this application can obtain puncture information through medical imaging equipment, automatically mark the puncture point position on the human body through a positioning device, obtain real-time puncture angle information through an intelligent puncture needle, and monitor the puncture angle in real time, thereby providing guidance on key information during the puncture process, namely the puncture point position and puncture angle, to accurately guide the puncture. The system is simple to construct. Medical imaging equipment is currently standard equipment in hospitals. As long as a positioning device, an intelligent puncture needle, and a host computer are added, the puncture navigation function of this system can be realized, greatly reducing the diagnosis and treatment costs of hospitals and patients. The system can also realize the navigation function without the image registration process, avoiding puncture deviation or failure caused by image registration errors. In addition, the use of the intelligent puncture needle does not have to be limited to the constraints of the robotic arm. It can be flexibly used and adjusted according to actual conditions during the puncture process. It can also measure the puncture angle information in real time according to the changes in the human body during the operation and display it on the host computer, greatly improving the efficiency and accuracy of the puncture. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG1 is a schematic diagram of the module structure of an intelligent puncture navigation system according to one or more embodiments;

[0012] FIG2 is a schematic diagram of the installation structure of a positioning device in an intelligent puncture navigation system according to one or more embodiments;

[0013] FIG3 is a schematic structural diagram of a positioning device in an intelligent puncture navigation system according to one or more embodiments;

[0014] FIG4 is a schematic structural diagram of a positioning device in an intelligent puncture navigation system without a frame according to one or more embodiments;

[0015] FIG5 is a schematic structural diagram of a puncture needle in an intelligent puncture navigation system according to one or more embodiments;

[0016] FIG6 is a schematic diagram of a portion of the structure of FIG5 after the housing is hidden;

[0017] FIG7 is a cross-sectional view of FIG5;

[0018] FIG8 is another schematic structural diagram of a puncture needle of an intelligent puncture navigation system according to one or more embodiments;

[0019] FIG9 is a schematic structural diagram of the housing in FIG8 ;

[0020] FIG10 is a cross-sectional view of FIG9;

[0021] FIG11 is a schematic structural diagram of an elastic clip according to one or more embodiments;

[0022] FIG12 is a schematic structural diagram of a first pogopin connector and a first pogopin connector according to one or more embodiments;

[0023] FIG13 is a schematic diagram of the arrangement of holes on a housing according to one or more embodiments;

[0024] FIG14 is a schematic structural diagram of a cannula provided on a puncture needle according to one or more embodiments;

[0025] FIG15 is a schematic structural diagram of a sleeve according to one or more embodiments;

[0026] FIG16 is a schematic structural diagram of a second pogopin connector arrangement according to one or more embodiments;

[0027] FIG17 is a schematic structural diagram of a puncture needle fixing device according to one or more embodiments;

[0028] FIG18 is a cross-sectional view of a buckle body according to one or more embodiments;

[0029] FIG19 is a schematic diagram of an OC coordinate system according to one or more embodiments;

[0030] FIG20 is a schematic diagram of an OU coordinate system according to one or more embodiments.

[0031] Figures: 1-medical imaging device; 11-scanning bed; 2-host computer; 3-positioning device; 31-first track; 311-first frame; 312-first conveyor belt; 313-first motor; 32-second track; 321-second frame; 322-second conveyor belt; 323-second motor; 33-laser emitter; 34-connecting plate; 4-intelligent puncture needle; 41-puncture needle; 411-needle core; 412-needle sleeve; 4121-needle sleeve rod; 4122-needle sleeve handle; 41221-first mounting plane; 41222-card slot; 42-housing; 421-second mounting plane; 422-card block; 423 -elastic clip; 424-anti-slip protrusion; 425-first pogopin connector; 426-first pogopin connector base; 427-second pogopin connector base; 43-sleeve; 431-laser receiver; 432-second pogopin connector; 5-puncture needle fixing device; 51-silicone fixing plate; 511-hanging ring; 52-adjustment device; 521-adjustment rope; 522-lock body; 523-adjustment button; 524-fixing hook; 53-hook. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0033] There are two commonly used puncture surgical navigation systems in the prior art: optical navigation systems and magnetic navigation systems. Both systems can match the human body with a virtual image and guide punctures, making puncture procedures more intuitive and visual. However, both optical and magnetic navigation systems require a matching process with the virtual image, which can easily result in matching errors, affecting the subsequent puncture guidance process and even causing puncture failure. Furthermore, while the robotic arm that guides the puncture can theoretically be adjusted to multiple angles, it often requires adjustment during the puncture process. Because the puncture needle is already partially inserted into the body, the adjustment process is not a simple one-to-one adjustment due to muscle grip, as well as the rigidity and toughness of the puncture needle. For example, to adjust the puncture needle by 15 degrees, it may be necessary to push down or push up the needle 30 or even 50 degrees before the needle naturally rebounds to achieve the desired 15-degree adjustment. In this case, these robotic arms are inconvenient and inflexible to use. Furthermore, current puncture surgical navigation systems are expensive and costly, but the actual results are not satisfactory. Moreover, the matching process between the human body and the virtual image generally takes 30-40 minutes, which also increases the time and risk of the operation.

[0034] In order to solve the above problems, in an application example, the present application provides an intelligent puncture navigation system, as shown in Figure 1, including a medical imaging device 1, a host computer 2, a positioning device 3 and an intelligent puncture needle 4.

[0035] The medical imaging device 1 is used to obtain a three-dimensional scan image of the tissue to be punctured. Medical imaging devices are primarily CT or MRI equipment commonly used in hospitals. CT includes conventional CT equipment and cone-beam CT (CBCT). For example, CT equipment typically scans the human body to obtain a cross-sectional scan image, which can then be reconstructed into a three-dimensional scan image.

[0036] The host computer 2 is used to determine the puncture information based on the 3D scan image. After the 3D scan image of the tissue to be punctured is obtained by the medical imaging device 1, it is transmitted to the host computer 2. The doctor will then determine the puncture information based on the 3D scan image on the host computer. First, the needle insertion level must be determined. The puncture path is determined based on the anatomical structure and tumor location. The puncture path avoids important organs such as nerves, blood vessels, and bones. The puncture information is then further determined, mainly including the puncture point location, puncture angle, and needle insertion depth.

[0037] The positioning device 3 is used to mark the skin surface of the puncture site according to the puncture information. The positioning device 3 communicates with the host computer 2, transmits the puncture point coordinate information to the positioning device 3, and forms a linkage, mainly used to mark the puncture site on the skin surface.

[0038] The smart puncture needle 4 is used to perform puncture according to the mark and the puncture information, and obtain real-time angle information of the smart puncture needle. Common puncture needles are provided with scales, so the doctor can observe the needle insertion depth at any time during puncture, but the puncture angle cannot be observed intuitively. However, when using the smart puncture needle 4 of the present application, the real-time puncture angle can be obtained. The smart puncture needle 4 is formed by integrating smart sensors, such as angle sensors, gyroscopes, etc., on ordinary puncture needles to form a smart puncture needle, which can realize the acquisition of real-time angle information of the puncture needle during the puncture process.

[0039] The host computer 2 is also used to monitor the smart puncture needle 4 according to the real-time angle information. After obtaining the real-time angle information of the smart puncture needle 4, the information is transmitted to the host computer 2, which monitors the puncture angle of the puncture needle 41 according to the real-time angle information.

[0040] When the intelligent puncture navigation system in the above embodiment is used, it first obtains a three-dimensional scanning image of the part to be punctured based on the medical imaging device 1, and then the host computer 2 determines the puncture information based on the three-dimensional scanning image. The puncture information generally includes the puncture point position, the puncture angle, and the needle insertion depth. The system also includes a positioning device 3, which can form a mark on the skin surface of the part to be punctured based on the puncture information, that is, mark the position on the human skin based on the puncture point position information. At the same time, when using the intelligent puncture needle 4 for puncture, the needle insertion depth can be known by observing the scale value on the puncture needle. The real-time angle information of the puncture needle can also be obtained through the intelligent puncture needle 4, which is used to compare with the puncture angle information during the puncture process to know whether the puncture angle deviates from the setting. In addition, the host computer 2 can also monitor the intelligent puncture needle 4 based on the real-time angle information to achieve automatic monitoring of the puncture needle 41.

[0041] The intelligent puncture navigation system of the present application can automatically mark the puncture point position on the human body through the positioning device 3 after obtaining the puncture information, obtain the real-time angle information of the puncture through the intelligent puncture needle 4, and monitor the puncture angle in real time, thereby guiding the key information in the puncture process, namely the puncture point position and the puncture angle, to guide the puncture. The system is simple in composition. Medical imaging equipment and host computers are standard equipment in current hospitals. As long as the positioning device 3 and the intelligent puncture needle 4 are added, the puncture navigation function of the system can be realized, greatly reducing the diagnosis and treatment costs of the hospital and patients. The system can also realize the navigation function without the image registration process, avoiding puncture deviation or failure caused by image registration errors. In addition, the use of the intelligent puncture needle 4 does not have to be limited to the constraints of the robotic arm. It can be flexibly used and adjusted according to the actual situation during the puncture process, and the next operation can be determined based on the real-time angle information, which greatly improves the efficiency and accuracy of the puncture.

[0042] In one embodiment, the host computer 2 is further configured to form a simulated animation on the three-dimensional scanned image based on the real-time angle information. The simulated animation is primarily used to simulate the puncture needle's puncture process, primarily the angle change process of the puncture needle. This simulated animation differs from the simulated animation in the prior art puncture surgery navigation system in that the simulated animation in the present application collects the real-time angle information of the puncture needle and then uses this real-time angle information to simulate the angle change of the puncture needle, which is a real-time monitoring behavior. The prior art puncture surgery navigation system simulates the virtual human body in the image and the real human body to accurately match them, using the virtual image data to guide the puncture direction. This is a pre-emptive behavior that requires very high accuracy, and is therefore prone to "a slight error leading to a great error." In comparison, the real-time simulation used in the present application is more instructive.

[0043] In one embodiment, monitoring the smart puncture needle based on the real-time angle information includes issuing an alarm when the angle difference between the real-time angle information and the puncture information exceeds a first set angle value. The alarm may be a visual alarm, an audible alarm, or a combination thereof. The visual alarm may include a flashing light, a color change in the image, or the like, and the audible alarm may include a buzzer, a voice prompt, or the like.

[0044] In a specific embodiment, a specific form of alarm information is provided, and the alarm information is a visual alarm. Assume that the puncture angle is a, the real-time angle information is b, and the first set angle value is c. When b∈(ac,a+c), the alarm information is that the puncture needle in the simulation animation is displayed in the first set color; when When the puncture needle is displayed in the second set color. For example, the first set color can be set to green and the second set color can be set to red. When the puncture needle's puncture angle is within the normal error range, the puncture needle in the virtual animation is green, indicating that the puncture is proceeding normally and it is safe to continue. When the puncture angle exceeds the normal error range, the puncture needle in the virtual animation is red, indicating that the puncture angle has deviated, prompting the doctor to correct the deviation.

[0045] In this embodiment, the specific structure of the positioning device 3 is provided to achieve its function. As shown in Figure 2, the positioning device 3 includes a first track 31 and a second track 32. The first track 31 and the second track 32 are arranged directly above the scanning bed 11 of the medical imaging device 1. The first track 31 is arranged parallel to the length of the scanning bed 11, and the second track 32 is arranged perpendicular to the first track 31. The first track 31 is arranged on the first track 31 and can slide along the first track 31. A laser emitter 33 is arranged on the lower side of the second track 32, facing the scanning bed 11. The laser emitter 33 can move along the second track 32. The positioning device 3 also includes a microcontroller and a wireless communication module. The wireless communication module and the laser emitter are electrically connected to the microcontroller. The microcontroller is used to control the movement of the first track 31 and the second track 32.

[0046] During installation, the positioning device 3 needs to be positioned directly opposite the scanning bed 11 of the medical imaging device 1, as shown in Figure 2. For example, it can be fixed to the ceiling directly opposite the scanning bed 11. Two rails are arranged perpendicularly, with a first rail 31 running parallel to the length of the scanning bed 11. A second rail 32 is mounted on the first rail 31 and can slide along it. A laser emitter 33 is positioned below the second rail 32. The laser emitter 33 should be positioned directly opposite the scanning bed 11 so that its light can illuminate the patient lying on the scanning bed 11. The laser emitter 33 is fixed to the second rail 32, and when the second rail 32 moves, it drives the laser emitter 33 along it. The device also includes a microcontroller and a wireless communication module. The wireless communication module and the laser emitter 33 are electrically connected to the microcontroller, which controls the movement of the first and second rails 31 and 32.

[0047] Before use, the device must be aligned with the medical imaging device 1 to ensure consistent coordinates. During use, the doctor first determines the puncture point location and puncture angle based on the scanned image on the host computer 2. Once the puncture point is located, its spatial coordinates are determined. The host computer 2 then wirelessly communicates with the microcontroller, sending the coordinate information to the microcontroller. The microcontroller then controls the movement of the first track 31 and the second track 32 based on the puncture point coordinate information, adjusting the laser emitter 33 to the coordinate position. The microcontroller then controls the laser emitter to emit laser light, and the laser spot that hits the body is the puncture point location.

[0048] The positioning device 3, by setting up automated equipment, is linked with the medical imaging device 1 and the host computer 2. After determining the puncture point, it can automatically mark the puncture point on the human body according to the spatial coordinate information of the puncture point using a laser transmitter 33. It is easy and accurate to use, and avoids errors caused by manual measurement.

[0049] In a specific embodiment, the present application provides a specific structure of a first track 31, as shown in Figure 3. The first track 31 includes a first frame 311 and a first conveyor belt 312. The first frame 311 has rotating shafts at both ends, and the ends of the first conveyor belt 312 are fixed to the rotating shafts. The first frame 311 is provided with a first motor 313 for driving the rotating shaft. The first motor 313 is electrically connected to a microcontroller. By setting the specific structure of the conveyor device, the microcontroller can control the movement of the first track 31.

[0050] In one embodiment, the plane formed by the midline of the first frame 311 and the midline of the scanning bed 11 is perpendicular to the scanning bed 11. The midline of the first frame 311 refers to the midline along its length, and the midline of the scanning bed 11 is also the midline along its length. By setting the plane containing the two planes perpendicular to the scanning bed 11, the first frame 311 is positioned directly above the scanning bed 11, facilitating the matching of the coordinates of the medical imaging device 1 and the intelligent puncture positioning device 3.

[0051] In one embodiment, as shown in Figure 3, the second track 32 includes a second frame 321 and a second conveyor belt 322. The second frame 321 is slidably connected to the first frame 311 and fixedly connected to the first track 31. A rotating shaft is provided at both ends of the inner side of the second frame 321, and both ends of the second conveyor belt 322 are fixed to the rotating shaft. A second motor 323 is provided on the second frame 321 for driving the rotating shaft. The second motor 323 is electrically connected to the microcontroller. The second frame 321 is slidably connected to the first frame 311 and fixedly connected to the first track 31, so that the first frame 311 can bear the weight of the second frame 321, while the first conveyor belt 312 can also drive the movement of the second frame 321.

[0052] This embodiment provides a specific structure in which a second frame 321 is disposed on a first frame 311. As shown in Figures 3 and 4, the second frame 321 is fixed to a connecting plate 34, which is slidably connected to the first frame 311 and fixed to a second conveyor belt 322. A laser emitter 33 is fixed to the second conveyor belt 322.

[0053] In one embodiment, the laser emitter 33 is a cross laser emitter that emits a cross laser point for easy positioning.

[0054] In this embodiment, a specific structure of the intelligent puncture needle 4 is provided to realize its function. The intelligent puncture needle 4 of this embodiment includes a puncture needle 41, which is provided with a gyroscope, a Bluetooth module and a power module. The gyroscope and the Bluetooth module are electrically connected to the power module respectively. Among them, the gyroscope is used to pick up the angle between the puncture needle 41 and the set reference plane; the Bluetooth module is used for wireless communication to transmit the detected angle information to a mobile phone, a host computer 2 or a tablet computer; and the power module supplies power to the gyroscope and the Bluetooth module. By integrating the gyroscope, the Bluetooth module and the power module on an ordinary puncture needle, the puncture angle of the puncture needle can be detected in real time. Therefore, during puncture, if the puncture angle deviates, it can be discovered in time to avoid puncture failure caused by the deviation of the puncture angle, such as puncturing blood vessels, bones or other important parts.

[0055] In one embodiment, as shown in FIG5 or FIG8 , a housing 42 is provided on the puncture needle 41, and the gyroscope, Bluetooth module, and power module are all disposed within the housing 42. During puncture, it is important for the puncture needle to be portable and lightweight, requiring both compactness and symmetrical weight. To meet this requirement, the housing 42 is configured with an "n"-shaped cross-section. This allows for a reasonable arrangement to ensure that the weight of both sides of the housing is equal, while also leaving space for the connection cables.

[0056] In one embodiment, the gyroscope and Bluetooth module are integrated on a circuit board and disposed within one side of the housing 42, while the power module is disposed within the other side of the housing 42, as shown in FIG6 . Furthermore, a control switch, such as an electromagnetic switch, may also be integrated on the circuit board. This divides the electronic components attached to the smart puncture needle 4 into two categories: one is the gyroscope, Bluetooth module, etc., which can be integrated on the circuit board and disposed within one side of the housing 42, while the heavier power module is disposed within the other corresponding side of the housing 42, thereby balancing the weight and making the weight on both sides of the housing 42 roughly balanced. Furthermore, the wiring between the power module and the circuit board can be arranged within the sidewalls connecting the two sides of the housing 42.

[0057] In another embodiment, another power supply method for powering the circuit board is provided based on the structure of the housing. As shown in Figures 12 and 13, a first pogopin connector 425 is electrically connected to the circuit board, and a first pogopin connector base 426 is electrically connected to the power supply. The first pogopin connector 425 and the first pogopin connector base 426 are arranged relative to each other and form contact. A hole is provided on the housing 42 corresponding to the position where the first pogopin connector 425 and the first pogopin connector base 426 contact. The pogopin connector includes a pogopin connector and a pogopin connector base, which is compact and space-saving. It is very suitable for use in the compact housing of this application, without the need for wiring, saving space. A hole is provided on the shell 42 at a position corresponding to the contact between the first pogopin connector 425 and the first pogopin connector seat 426, as shown in Figure 13. When not in use, an insulating paper sheet can be placed between the first pogopin connector 425 and the first pogopin connector seat 426 to save electricity. When in use, the insulating paper sheet can be removed to turn on the power. This setting can realize power on and off without installing a switch chip, saving space in the shell, which is very convenient and practical.

[0058] In one embodiment, after the circuit board is secured within the housing 42, the plane on which the circuit board resides is parallel to the axis of the puncture needle 41. This design facilitates the gyroscope's detection of the rotation angle of the puncture needle 41, simplifying the calculation process. In one specific embodiment, a nine-axis Bluetooth module can be used in place of the Bluetooth module and gyroscope. This nine-axis Bluetooth module integrates the functions of a Bluetooth module and a gyroscope into a single chip. This compact and powerful chip is well-suited for use in the smart puncture needle of this application.

[0059] Two specific embodiments are provided below to illustrate the installation method and position of the housing 42 on the puncture needle 41.

[0060] As shown in FIG5 , the puncture needle 41 generally includes a coaxially arranged needle core 411 and a needle guard 412. The needle guard 412 generally includes a metal needle guard rod 4121 and a plastic needle guard handle 4122, which are fixed together by injection molding or adhesive bonding. In a specific embodiment, the housing 42 is fixed to the needle guard handle 4122 of the puncture needle, as shown in FIG5 .

[0061] The lower end of the needle guard handle 4122 is thinner to facilitate connection with the needle guard rod 4121, while the upper end is thicker to facilitate gripping the puncture needle. The junction between the upper and lower ends forms a gradual transition, gradually increasing in thickness from bottom to top. The housing 42 has an "N"-shaped cross-section. To accommodate the shape of the needle guard handle 4122, the housing 42 is configured to be larger at the top and smaller at the bottom, as shown in Figure 7.

[0062] In one embodiment, as shown in Figures 5 and 7, first mounting surfaces 41221 are symmetrically provided on both sides of the lower end of the needle sleeve handle 4122, with a latching slot 41222 disposed above the first mounting surface. Second mounting surfaces 421 are symmetrically provided on both sides of the lower end of the housing 42, matching the first mounting surfaces 41221. A latching block 422 matching the latching slot is disposed above the second mounting surface 421. By providing the first mounting surface 41221 on the lower end of the needle sleeve handle, the second mounting surface 421 on the inner side of the housing 42, and the matching latching slot 41222 and latching block 422, the housing 42 can be conveniently secured to the needle sleeve handle 4122.

[0063] In one embodiment, the smart puncture needle also includes a sleeve 43, as shown in Figure 14, the sleeve 43 is detachably mounted on the outside of the needle sleeve 412 of the puncture needle 41, and a flexible circuit board is provided inside the side wall of the sleeve 43 along its length direction. As shown in Figures 15 and 16, at least two laser receivers 431 are provided on the flexible circuit board, and corresponding to the laser receivers 431, a hole is provided on the sleeve 43, and a second pogopin connector 432 is provided at the end of the sleeve 43, and the second pogopin connector 432 is electrically connected to the flexible circuit board, and a second pogopin connector 427 is provided on the lower side of the corresponding shell, and the second pogopin connector 427 is electrically connected to the circuit board.

[0064] Because the needle sleeve handle 4122 is thinner at the bottom and thicker at the top, with the connection between the two ends forming a gradual transition, the cannula 43 can be removably mounted on the needle sleeve handle 4122. A second pogopin connector 432 disposed at the end of the cannula 43 corresponds to a second pogopin connector seat 427 disposed on the underside of the housing. When the cannula 43 is secured to the needle sleeve handle 4122, the second pogopin connector 432 can be inserted into the second pogopin connector seat 427, achieving electrical communication. In one specific embodiment, the cannula 43 is provided with two laser receivers 431, arranged along a straight line parallel to the axis of the puncture needle.

[0065] The above setting is to complete the alignment of the smart puncture needle 4 and the medical imaging device 1. Taking the CT device as an example, the alignment of the CT device is to emit a laser at the set zero point position. At this time, the doctor holds the laser receiver 431 on the smart puncture needle to pick up the laser. When the two laser receivers 431 located on the same straight line pick up the laser, the position is set as the zero point of the puncture needle.

[0066] When in use, remove the insulating paper between the first pogopin connector 425 and the first pogopin connector 426, power on the smart puncture needle, and power on the second pogopin connector 432 and the second pogopin connector 427 for communication. When the laser receiver 431 receives the laser signal, it will transmit the information to the host computer through the Bluetooth module. When the host computer receives the signals transmitted by the two laser receivers 431 at the same time, the position of the puncture needle at this time is set to the zero position, thereby realizing automatic alignment with the medical imaging equipment.

[0067] In another embodiment, the housing 42 is removably attached to the needle shaft 4121 of the puncture needle. This removable connection facilitates the reuse of the smart component. The housing 42 has an "n"-shaped cross-section. To accommodate the shape of the needle shaft 4121, the housing 42 is uniform in size from top to bottom, as shown in Figure 8.

[0068] As shown in Figure 8, an elastic clip 423 is provided on the inner side of the shell 42 to match puncture needles of different thicknesses. As shown in Figure 11, the cross section of the elastic clip 423 is in the shape of an "n" and is integrally formed from a metal sheet. The outer side of the elastic clip 423 is a right angle, the inner side is an arc, and the connection between the inner and outer sides is an arc-shaped transition. The use of an integral metal sheet makes it convenient to utilize the mechanical deformation of the metal sheet to generate elastic force, thereby fixing the puncture needle. In order to adapt to the shape of the shell 42, the cross section of the elastic clip 423 is also in the shape of an "n", and the outer side of the elastic clip 423 is a right angle to adapt to the shape of the inner side of the shell, while the inner side of the elastic clip 423 is an arc to adapt to the shape of the puncture needle.

[0069] As shown in Figures 9 and 10, the rear side of the elastic clip 423 is provided with a groove, which corresponds to the protrusion on the inner side of the housing 42. The elastic clip 423 is fixed together by the protrusion and the groove. In order to prevent slipping when grasping, the outer side of the housing 42 is provided with an anti-slip protrusion 424.

[0070] The existing step-by-step needle insertion method involves scanning during puncture to confirm the correct puncture path and avoid accidental punctures. During the puncture process, the patient is scanned alone in the scanning room to avoid radiation exposure. Since the puncture needle is partially inserted, it is difficult to secure it. It is also impossible to determine whether the puncture direction has shifted due to movement or other factors during the scan.

[0071] This embodiment provides a puncture needle fixing device 5 for use during a puncture procedure when the puncture needle has been partially inserted into the body, as shown in FIG17 . The device comprises a silicone fixing plate 51, an adjusting device 52, and a hook 53. The adjusting device 52 comprises an adjusting rope 521 and an adjusting buckle. The adjusting buckle comprises a buckle body 522 and an adjusting rope 521. One end of the adjusting rope 521 is fixedly connected to the buckle body 522 and passes through the buckle body 522 to connect to the silicone fixing plate 51. The other end of the adjusting rope 521 passes through the buckle body 522 and is adjustably connected to the buckle body 522. One end of the hook 53 is slidably connected to the bend of the adjusting rope 521.

[0072] The puncture needle securing device includes a silicone securing plate 51. Made of medical silicone, it is skin-friendly and soft, allowing it to conform to human skin without being affected by skin shape. With the appropriate thickness and size, it can support the puncture needle through its own weight and friction with the skin. A hook 53 is used to hold the puncture needle. The hook 53 and silicone securing plate 51 are connected by an adjustment device 52. This device not only adjusts the distance between the hook 53 and the silicone securing plate 51, but also supports the hook 53, facilitating adjustment of the puncture needle's fixed angle.

[0073] The adjusting device 52 includes an adjusting rope 521 and a lock body 522. Both ends of the adjusting rope 521 pass through the lock body 522. One end is fixed on the lock body 522 and connected to the silicone fixing plate 51, and the other end is in an adjustable state, that is, the length of the free end located on the outside of the lock body 522 can be adjusted, thereby adjusting the distance between the hook 53 and the silicone fixing plate 51. One end of the hook 53 is slidably connected to the bend of the adjusting rope 521 to ensure that one end of the hook 53 is always located near the midpoint of the bend.

[0074] During use, the hook 53 is first hooked onto the puncture needle to be fixed. The hook 53 and the adjustment device 52 are then stretched to place the silicone fixing plate 51 on the patient's skin at the appropriate position. The length of the free end of the adjustment cord 521 is then fine-tuned to the appropriate position to fix the puncture needle. Furthermore, the position of the hook 53 on the puncture needle can be adjusted to adjust the direction of the puncture needle fixation. This puncture needle fixing device can fix the puncture needle during puncture scanning without affecting the scanning process, and is convenient and quick to use.

[0075] In a specific embodiment, a specific structure of an adjustment device is provided, as shown in Figure 18, a fixing hole and an adjustment hole are correspondingly provided on the lock body 522, one end of the adjustment rope 521 passes through the fixing hole and is connected to the silicone fixing plate 51, the adjustment rope 521 is fixedly connected to the fixing hole, and the other end of the adjustment rope 521 passes through the adjustment hole, and an adjustment button 523 is provided on the adjustment hole. When the adjustment button 523 is pressed, the adjustment rope 521 can move back and forth along the adjustment hole. When the adjustment button 523 is released, the adjustment rope 521 is fixed in the adjustment hole.

[0076] In one embodiment, as shown in Figure 17 , a loop 511 is provided on one side of the silicone fixing plate 51. A fixing hook 524 is provided at the fixed end of the adjustment cord 521, which is hooked into the loop 511. As shown in Figure 18 , a through hole is provided at the lower end of the adjustment button 523. Once the adjustment button 523 is mounted on the buckle body, the through hole corresponds to the adjustment hole. The adjustment button 523 is secured to the buckle body 522 via a spring. This simple structure is easy to operate.

[0077] In this application, a smart puncture needle 4 is used. Because it incorporates a smart chip, the needle handle 4122 is heavier. If the needle is not secured during distributed insertion, gravity can significantly affect the puncture direction. Therefore, a puncture needle securing device 5 is provided to secure the smart puncture needle 4. Furthermore, because the needle's real-time angle information can be obtained in real time, it is possible to determine whether the puncture angle has shifted during the step-by-step needle insertion scan, ensuring the accuracy of subsequent punctures.

[0078] A dedicated robotic arm, such as a six-axis one, can also be configured to secure the intelligent puncture needle 4, allowing for flexible and convenient adjustment. The robotic arm can be made of carbon steel to avoid interfering with the normal operation of the medical imaging equipment. Unlike the robotic arms used in optical and magnetic navigation systems, the robotic arm used in the intelligent puncture navigation system does not require an angle display or a puncture guide; it serves only as a support and fixation mechanism.

[0079] In order to simplify calculations and improve coordination between components, this application adopts a trinity coordinate system, that is, the positioning device 3, the intelligent puncture needle 4 and the medical imaging device 1 share a coordinate system, and all use the coordinate system of the medical imaging device 1. Medical imaging equipment will adjust the installation environment during installation, such as the horizontal plane (ground), installation orientation, etc., so it is most reasonable to match the coordinate system of the positioning device 3 and the intelligent puncture needle 4 with the coordinate system of the medical imaging device 1. After alignment, the physical entity is accurately mapped to the virtual entity, and then the free observation characteristics of the virtual space are used to guide the physical puncture service.

[0080] Based on this, the present application also provides another application example, which provides an intelligent puncture navigation method, which is applied to the intelligent puncture navigation system described above, and the method includes:

[0081] 1) Establishing an OC coordinate system based on a medical imaging device; establishing an OL coordinate system based on a positioning device; wherein the x-axis and z-axis directions of the OC coordinate system and the OL coordinate system are the same.

[0082] 2) Determine the mapping relationship from the OC coordinate system to the OL coordinate system.

[0083] 3) Using the medical imaging device to obtain a three-dimensional scanning image of the tissue to be punctured.

[0084] 4) Using a host computer to determine puncture information based on the three-dimensional scanning image, wherein the puncture information includes the puncture point position, puncture angle, and needle insertion depth.

[0085] 5) Establishing an OP coordinate system based on the position of the tissue to be punctured, and determining a mapping relationship from the OP coordinate system to the OC coordinate system; wherein the coordinate origin of the OP coordinate system is located at the needle insertion point; the needle insertion point is the position where the positioning device forms a mark on the skin surface of the tissue to be punctured based on the puncture information.

[0086] 6) Based on the mapping relationship between the OL coordinate system and the OC coordinate system and the mapping relationship between the OP coordinate system and the OC coordinate system, determine the mapping relationship between the OP coordinate system and the OL coordinate system.

[0087] 7) Establishing an OU coordinate system based on the position of the tissue to be punctured in the virtual space, and determining a mapping relationship from the OC coordinate system to the OU coordinate system; wherein the coordinate origin of the OU coordinate system is the needle insertion point position on the tissue to be punctured in the virtual space.

[0088] 8) Establishing a one-dimensional ON coordinate system based on the intelligent puncture needle; wherein the coordinate origin of the one-dimensional ON coordinate system is the needle tip position of the puncture needle.

[0089] 9) In the virtual space, a puncture process is simulated based on the puncture information to determine a virtual puncture needle tip position of the puncture needle.

[0090] 10) Determining real-time angle information based on the virtual puncture needle tip position of the puncture needle.

[0091] 11) Guiding puncture of the smart puncture needle based on the real-time angle information.

[0092] The specific implementation principle is described using CT as an example, involving the relationship and mutual conversion of multiple coordinate systems. The OC coordinate system is shown in Figure 19, and the OU coordinate system is shown in Figure 20. The specific steps are as follows:

[0093] ① CT Cartesian coordinate system: C(x,y,z), OC(xC,yC,zC), the coordinate origin is located at a point in the air where the CT cross laser is directly projected when the CT bed is reset.

[0094] ② Cartesian coordinate system of positioning device 3: L(x,z), OL(xL,zL), with the origin of the coordinate system located at the center of positioning device 3.

[0095] ③ The left-handed three-dimensional Cartesian coordinate system of the virtual space: U(x,y,z), OU(xU,yU,zU), the coordinate origin is located at the spatial position of the needle tip in the virtual space.

[0096] ④ The body’s right-handed three-dimensional Cartesian coordinate system: P(x,y,z), OP(xP,yP,zP), with the origin of the coordinate system located at the spatial position of the needle insertion point on the skin.

[0097] ⑤ One-dimensional coordinate axis of the intelligent puncture needle 4: N(s), ON(sN), with the origin of the coordinate located at the needle tip.

[0098] The steps for converting between coordinates are as follows:

[0099] Step 1: Establish the CT coordinate system OC, as shown in Figure 19.

[0100] Step 2: Establish the OL coordinate system, where the xL axis is parallel to the xC axis and has the same direction; the zL axis is parallel to the zC axis and has the same direction.

[0101] Step 3: Establish the mapping from OL to OC. After the positioning device 3 is installed, use the host computer 2 to control the positioning device 3 to return to the coordinate origin. Turn on the laser emitter 33, place the debugging board on the CT bed, align the laser with the metal cross, and then maintain the debugging board in place. Perform a CT scan on the debugging board. The coordinates of the center point of the debugging board's metal cross, OC (x0, y0, z0), are read out on the CT software. This establishes the mapping relationship from OC to OL. The coordinates of OL (0,0,0) in the OC are OC (x0, y0 + h, z0), where h is a constant and can be omitted. When the CT bed moves a distance s1 in the negative z-axis direction, the coordinates of OL (0,0,0) in the CT remain unchanged, remaining OC (x0, y0 + h, z0).

[0102] Step 4: Establish the OP coordinate system and create a mapping from OP to OC. After the CT scan is completed, the CT table returns to its initial position. The OP coordinate system now completely overlaps with the OC coordinate system, and the coordinates of OP (xP, yP, zP) in the CT scan are OC (xC, yC, zC). After the CT table moves a distance s1 in the negative z-direction, the coordinates of OP (xP, yP, zP) in the CT scan are OC (xC, yC, zC - s1).

[0103] After the CT scan, the optimal puncture path, skin puncture point, and puncture angle are planned based on the lesion location, avoiding critical surrounding tissues and organs. The coordinates of the puncture point P1 (xC1, yC1, zC1) and the corresponding skin entry point P2 (xC2, yC2, zC2) are located on the CT image. The roll angle θ and pitch angle α are measured from P2 to P1. Both angles are defined as the angle between the needle's mid-axis and the negative yC axis. Their values ​​are always non-negative and range from [0 to 180]. θ is measured on the CT transverse image, and α is measured on the CT sagittal image.

[0104] When the CT bed moves a distance s1 in the negative direction of the z-axis, the coordinates of P1 in the OC coordinate system are (xC1, yC1, zC1-s1), and the coordinates of P2 in the OC coordinate system are (xC2, yC2, zC2-s1), and the roll angle θ and pitch angle α remain unchanged.

[0105] Step 5: Establish an OP to OL mapping. After the CT bed moves a distance s1 in the negative z-axis direction, the skin insertion point P2 has coordinates (xC2, yC2, zC2-s1) in the OC coordinate system, which correspond to coordinates (xC2-x0, zC2-s1-z0) in the OL coordinate system. These coordinates are important for moving the center of the laser emitter 33 of the positioning device 3 to the planned skin insertion point.

[0106] Step 6: Establish the OU coordinate system and create an OC-to-OU mapping. The OU coordinate system is established when Unity3D is started. The origin of the OU coordinate system is located at the skin entry point. The xU axis is parallel to the xC axis and in the same direction, the yU axis is parallel to the yC axis but in opposite directions, and the zU axis is parallel to the zC axis but in opposite directions. When calculating the roll angle θ and pitch angle α in the OU coordinate system, the angle between the needle's mid-axis and the positive direction of the yU axis is used. Its value is always non-negative and ranges from [0,180] degrees. In the OU coordinate system, the origin of the OU coordinate system always coincides with the skin entry point. Since the OU coordinate system and the OC coordinate system have the same x-axis orientation and opposite y and z-axes, the positional deviation between the puncture point P1 and the skin entry point P2 in the OU coordinate system is Δx, -Δy, and -Δz. Therefore, the position of P1 in the OU coordinate system is OU(xC1-xC2, yC2-yC1, zC2-zC1).

[0107] Step 7: Establish the ON coordinate axis and establish a mapping from ON to OU. The ON coordinate axis is directly photoetched on the needle body, with the needle tip as the coordinate origin, the middle axis of the needle body as the s axis, the direction of the needle tail as positive, and any point at the coordinate ON (sN). The function of this axis is to guide the depth of the needle insertion, and the depth value is directly measured from the CT image. During the puncture process, there are two CT scans to verify the direction. Before scanning, the needle body scale value sN can be read and input into the host computer software to obtain the relative position of the current puncture needle and the point to be punctured. However, since the puncture needle may tip over, the spatial position of the needle insertion point will change. Therefore, the spatial position of the puncture needle displayed in the host computer software will have a certain deviation. It is for reference only. The specific position is subject to the CT scan image (the error here does not affect the accuracy of the final puncture). Under the ideal condition that the position of the skin needle entry point P2 remains unchanged, the coordinates of the puncture needle tip in OU are OU(±tanθ*sN / sqrt(1+tan2α+tan2θ), -sN / sqrt(1+tan2α+tan2θ), ±tanα*sN / sqrt(1+tan2α+tan2θ)), and the central axis of the needle body passes through OU(0,0,0).

[0108] Values ​​that need to be entered into the host computer software: System debugging phase: Enter the three values ​​of x0, y0, and z0 (recording the relative position relationship between the CT and the positioning device). Operation phase: z1 value, xC1, yC1, zC1 values, xC2, yC2, zC2 values, and needle insertion depth sN.

[0109] The needle's spatial attitude is calculated based on the quaternion data generated by the six-axis attitude sensor, which is transmitted to the host computer via Bluetooth. The host computer software calculates and displays the needle's spatial attitude based on the Unity3D engine. During Unity3D engine initialization, the needle's central axis is parallel to the z-axis, with the needle tip facing the negative z-axis. Since the six-axis attitude sensor chip's negative y-axis is oriented toward the needle tip and its negative z-axis is toward the center of the Earth, and it operates in a right-handed coordinate system, the quaternion output by the chip must be converted from (w, x, y, z) to (x, z, y, -w) when input into Unity3D's left-handed coordinate system.

[0110] The display of the needle body posture is based on Unity3D's Quaternion.RotateTowards function, which can realize the rotation of the object from the initial position to the given quaternion position. In this software, it is the rotation from the quaternion (0,0,0,0) to (x,z,y,-w).

[0111] The calculation of the needle's roll angle θ and pitch angle α is also based on quaternions. The specific method is to multiply the initial unit vector v1 (0, 0, 1) of the needle's central axis in the OU coordinate system by the rotation from (0, 0, 0, 0) to (x, z, y, -w) to obtain the rotated vector v2 (x2, y2, z2) of the needle's central axis. The roll angle θ = 90-arcsin(y2 / sqrt(y2*y2+x2*x2)) / π*180, and the pitch angle α = 90-arcsin(y2 / sqrt(y2*y2+z2*z2)) / π*180.

[0112] According to the above, the position of the puncture point P1 in the OU coordinate system is OU(xC1-xC2, yC2-yC1, zC2-zC1), and the position of the needle tip in the OU coordinate system is OU(±tanθ*sN / sqrt(1+tan2α+tan2θ), -sN / sqrt(1+tan2α+tan2θ), ±tanα*sN / sqrt(1+tan2α+tan2θ)), and the needle body always rotates around the OU coordinate system coordinate OU(0,0,0) of the skin insertion point P2.

[0113] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0114] This document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core concept of this application. At the same time, for those skilled in the art, based on the concept of this application, there may be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting this application.

Claims

1. An intelligent puncture navigation system, characterized in that, The intelligent puncture navigation system includes a medical imaging device (1), a host computer (2), a positioning device (3), and an intelligent puncture needle (4); The medical imaging device (1) is used to obtain a three-dimensional scanned image of the tissue to be punctured; the medical imaging device (1) is a CT or magnetic resonance imaging device; The host computer (2) is used to determine puncture information based on the three-dimensional scanned image, where the puncture information includes the puncture point position, the puncture angle, and the needle insertion depth; The positioning device (3) is used to form a mark on the skin surface of the puncture site according to the puncture information; the mark is the position of a point; The intelligent puncture needle (4) is used to perform puncture according to the mark and the puncture information, and obtain the real-time angle information of the intelligent puncture needle (4); The host computer (2) is also used to monitor the intelligent puncture needle (4) according to the real-time angle information; The positioning device (3), the intelligent puncture needle (4), and the medical imaging device (1) share a coordinate system; The positioning device (3) includes a first track (31) and a second track (32). The first track (31) and the second track (32) are arranged directly above the scanning bed (11) of the medical imaging device (1). The first track (31) is arranged parallel to the length direction of the scanning bed (11), and the second track (32) is arranged perpendicular to the first track (31) and is arranged on the first track (31) and can slide along it driven by the first track (31); on the lower side of the second track (32), a laser emitter (33) is arranged facing the scanning bed (11), and the laser emitter (33) can move along it driven by the second track (32); The positioning device (3) further includes a microcontroller and a wireless communication module. The wireless communication module and the laser emitter (33) are respectively electrically connected to the microcontroller, and the microcontroller is also used to control the movement of the first track (31) and the second track (32); The host computer (2) communicates wirelessly with the microcontroller, sends coordinate information to the microcontroller, and the microcontroller respectively controls the movement of the first track (31) and the second track (32) according to the coordinate information of the puncture point, adjusts the laser emitter (33) to the coordinate position. At this time, the microcontroller controls the laser emitter (33) to emit laser, and the laser hitting the human body is the puncture point position; The intelligent puncture needle (4) includes a sleeve (43). The sleeve (43) is detachably sleeved outside the needle sleeve (412) of the puncture needle (41). A flexible circuit board is arranged along the length direction inside the side wall of the sleeve (43), and at least two laser receivers (431) are arranged on the flexible circuit board. Corresponding to the laser receivers (431), Holes are provided on the sleeve (43), and a second pogopin connector (432) is provided at the end of the sleeve (43). The second pogopin connector (432) is electrically connected to the flexible printed circuit board. A second pogopin socket (427) is provided corresponding to the lower side of the housing (42), and the second pogopin socket (427) is electrically connected to the circuit board; The medical imaging device (1) emits a laser beam starting from a set zero position. The laser receiver (431) on the intelligent puncture needle (4) picks up the laser. When both laser receivers (431) on the same straight line pick up the laser, this position is set as the zero point of the puncture needle; After the intelligent puncture needle (4) is powered on, the second pogopin connector (432) and the second pogopin socket (427) are powered on for communication. When the laser receiver (431) receives a laser signal, it will transmit this information to the host computer (2) through the Bluetooth module. When the host computer (2) receives signals transmitted by both laser receivers (431) simultaneously, the position of the puncture needle (41) at this time is set as the zero point position, achieving automatic registration with the medical imaging device (1); The intelligent puncture navigation system further includes a puncture needle fixing device (5). The puncture needle fixing device (5) includes a silica gel fixing plate (51), an adjusting device (52), and a hook (53); The adjusting device (52) includes an adjusting rope (521) and an adjusting buckle. The adjusting buckle includes a buckle body (522). One end of the adjusting rope (521) is fixedly connected to the buckle body (522), passes through the buckle body (522), and is connected to the silica gel fixing plate (51). The other end of the adjusting rope (521) passes through the buckle body (522) and is adjustably connected to the buckle body (522). One end of the hook (53) is slidably connected to the bent portion of the adjusting rope (521); The silica gel fixing plate (51) forms a support for the puncture needle (41) through its own gravity and the friction with the skin; The hook (53) is used to hook the puncture needle (41). The hook (53) and the silica gel fixing plate (51) are connected through the adjusting device (52), which is used to adjust the distance between the hook (53) and the silica gel fixing plate (51) on the one hand, and also used to support the hook (53) to adjust the fixing angle of the puncture needle (41).

2. The intelligent puncture navigation system according to claim 1, characterized in that, The host computer (2) is further used to form a simulation animation on the three-dimensional scan image according to the real-time angle information.

3. The intelligent puncture navigation system according to claim 1, characterized in that, Monitoring the intelligent puncture needle according to the real-time angle information includes: when the angle difference between the real-time angle information and the puncture information is greater than a first set angle value, an alarm message is issued.

4. The intelligent puncture navigation system according to claim 3, characterized in that The puncture angle is a, the real-time angle information is b, and the first set angle value is c. When b ∈ (a - c, a + c), the alarm information is that the puncture needle in the simulation animation is displayed in the first set color; when , the puncture needle is displayed in the second set color.

5. The intelligent puncture navigation system according to claim 1, wherein A gyroscope, a Bluetooth module, and a power module are provided on the puncture needle (41), and the gyroscope and the Bluetooth module are respectively electrically connected to the power module.

6. The intelligent puncture navigation system according to claim 3, wherein The intelligent puncture navigation system further includes a display device; the display device is used to display the real-time angle information in real time.

7. The intelligent puncture navigation system according to claim 1, wherein, The first rail (31) includes a first frame (311) and a first conveyor belt (312). Rotating shafts are arranged at both inner ends of the first frame (311), and both ends of the first conveyor belt (312) are fixed on the rotating shafts; a first motor (313) is arranged on the first frame (311) for driving the rotating shafts to rotate; the first motor (313) is electrically connected to the microcontroller; the microcontroller controls the movement of the first rail (31); The second rail (32) includes a second frame (321) and a second conveyor belt (322). The second frame (321) is slidably connected to the first frame (311) and fixedly connected to the first rail (31); rotating shafts are arranged at both inner ends of the second frame (321), and both ends of the second conveyor belt (322) are fixed on the rotating shafts; a second motor (323) is arranged on the second frame (321) for driving the rotating shafts to rotate; the second motor (323) is electrically connected to the microcontroller; The laser emitter (33) is fixed on the second conveyor belt (322).

8. The intelligent puncture navigation system according to claim 1, characterized in that, The puncture needle (41) includes a coaxial needle core (411) and a needle sleeve (412); the needle sleeve 412 includes a needle sleeve rod (4121) and a needle sleeve handle (4122) fixed together; the housing (42) is fixed on the needle sleeve handle (4122) of the puncture needle (41).

9. The intelligent puncture navigation system according to claim 8, wherein On both sides of the lower end of the needle sleeve handle (4122), first mounting planes (41221) are symmetrically arranged, and a card slot (41222) is arranged above the first mounting plane (41221); on both sides of the inner part of the lower end of the housing (42), second mounting planes (421) matching the first mounting planes (41221) are symmetrically arranged, and a clamping block (422) matching the card slot (41222) is arranged above the second mounting plane (421).

10. An intelligent puncture navigation method, applied to the intelligent puncture navigation system according to any one of claims 1-9, characterized in that, The intelligent puncture navigation method includes: Establishing an OC coordinate system based on a medical imaging device; establishing an OL coordinate system based on a positioning device; where The x-axis direction and z-axis direction of the OC coordinate system are the same as those of the OL coordinate system; Determining the mapping relationship from the OC coordinate system to the OL coordinate system; Using the medical imaging device to obtain a three-dimensional scan image of the tissue to be punctured; Using a host computer to determine puncture information according to the three-dimensional scan image, where the puncture information includes the puncture point position, puncture angle, and needle insertion depth; Establishing an OP coordinate system based on the position of the tissue to be punctured and determining the mapping relationship from the OP coordinate system to the OC coordinate system; where the coordinate origin of the OP coordinate system is located at the needle insertion point position; the needle insertion point position is the position where the positioning device forms a mark on the skin surface of the tissue to be punctured according to the puncture information; Based on the mapping relationship from the OL coordinate system to the OC coordinate system and the mapping relationship from the OP coordinate system to the OC coordinate system, determining the mapping relationship from the OP coordinate system to the OL coordinate system; Establish an OU coordinate system based on the position of the tissue to be punctured in the virtual space, and determine the mapping relationship from the OC coordinate system to the OU coordinate system; wherein, the origin of the OU coordinate system is the position of the needle insertion point on the tissue to be punctured in the virtual space; Establish a one-dimensional ON coordinate system based on the intelligent puncture needle; wherein, the origin of the one-dimensional ON coordinate system is the position of the tip of the puncture needle; In the virtual space, simulate the puncture process based on the puncture information to determine the virtual puncture tip position of the puncture needle; Determine the real-time angle information based on the virtual puncture tip position of the puncture needle; Guide the puncture of the intelligent puncture needle based on the real-time angle information.

11. The intelligent puncture navigation method according to claim 10, characterized in that, The virtual puncture tip position of the puncture needle is OU(±tanθ*sN / sqrt(1+tan2α+tan2θ), -sN / sqrt(1+tan2α+tan2θ), ±tanα*sN / sqrt(1+tan2α+tan2θ)), and the central axis of the needle body of the puncture needle passes through the origin of the OU coordinate system; Wherein, θ and α respectively represent the side inclination angle and the pitch angle from the needle insertion point position on the tissue to be punctured to the puncture point position, and sN is the needle insertion depth.

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