An ultrasound plane-out puncture visualization assisted guiding method and system

Abstract

The present application relates to the field of medical devices, in particular to an ultrasonic plane external puncture visualized auxiliary guiding method and system, the method comprising the following steps: image acquisition, setting puncture angle, confirming puncture target point, confirming focal length and ultrasonic frequency and generating simulated puncture needle path; the system comprising clamping arm, guiding module, ranging module, trajectory generating module and image display module. The present application sets puncture target area based on ultrasonic slice thickness by using ultrasonic volume effect, increases the monitorable range of ultrasonic image to puncture needle in the puncture process, relatively expands the safety area of puncture operation, avoids that the needle tip is located outside the target point and deviates from the ultrasonic image monitoring; meanwhile, in the process from the puncture needle entering the skin to the puncture to the target, the projection point of the puncture needle tip in the central plane is output on the ultrasonic image of the monitor in real time to form a simulated puncture needle path, realizing the simulation visualization of the advancing trajectory of the puncture needle tip.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an ultrasound-guided extraplanar puncture visualization method and system. Background Technology

[0002] Ultrasound-guided intervention refers to the puncture of a target under the guidance of real-time ultrasound images, thereby performing corresponding diagnostic and therapeutic procedures such as pathological biopsy, aspiration of cyst fluid, catheter drainage, drug injection, and thermal ablation. It has the advantages of low risk, low cost, and good clinical treatment effect.

[0003] Currently, the main method of ultrasound-guided puncture is to use an auxiliary puncture frame to achieve in-plane or out-of-plane guidance. In-plane ultrasound-guided puncture refers to setting the puncture frame at one end of the long axis of the ultrasound transducer (probe) and advancing the puncture needle in a plane parallel to the long axis of the transducer. The puncture needle is coplanar with the ultrasound plane. In this way, the needle body and tip of the puncture needle can be continuously displayed on the ultrasound monitor throughout the entire process of the puncture needle reaching the target. Therefore, this is a safe and accurate guidance method. However, this method has a long puncture path and is prone to accidentally injuring adjacent tissues.

[0004] However, in scenarios where the anatomical location is narrow or the puncture needle length cannot reach the target, puncture can only be performed using ultrasound out-of-plane guided puncture that is close to the transducer's long axis. Out-of-plane guided puncture refers to setting the puncture frame at one end of the short axis of the ultrasound transducer near the center point of the ultrasound transducer, with the puncture needle located outside the ultrasound plane. Compared to in-plane puncture, out-of-plane puncture has a shorter needle insertion path and is less restricted by anatomical structures. However, most current extra-planar puncture frames are designed with a fixed angle, which cannot be adapted to puncture targets of different depths by changing the angle. In addition, because the ultrasound section and the puncture needle are in a cross-sectional relationship, extra-planar puncture cannot display the needle insertion path throughout the entire process. Although existing technologies can determine the point where the puncture path intersects with the ultrasound central plane (the ultrasound section formed by the midpoint of the physical thickness of the ultrasound probe is set as the central plane. Since the positional relationship between the ultrasound probe and the guiding module is fixed, the point where the puncture path at the corresponding angle intersects with the central plane can be obtained under a certain angle, which is the puncture target point) through mathematical trigonometric relationships, actual ultrasound-guided puncture often requires a certain amount of space to be reserved for puncture operations. For example, when using an automatic biopsy gun to obtain material, the puncture needle needs to be emitted about 2cm away from the target, or radiofrequency ablation surgery requires gradual needle withdrawal for complete tumor inactivation. Therefore, providing only one puncture target point will cause some processes of the above-mentioned surgical operations to be out of ultrasound image monitoring, which will easily increase the surgical risk. Summary of the Invention

[0005] Based on the above problems, the purpose of this invention is to provide a method and system for ultrasound-guided extraplanar puncture visualization.

[0006] The present invention adopts the following technical solution:

[0007] This invention provides a method for ultrasound-guided extraplanar puncture visualization, the method comprising the following steps:

[0008] Image acquisition: Acquire real-time ultrasound images of the target object, which is the site to be punctured under ultrasound guidance;

[0009] Set the puncture angle to confirm the puncture target point. Based on the position of the target object in the ultrasound image, select the puncture angle using an out-of-plane puncture method. After the puncture angle is determined, the point where the puncture path corresponding to the angle intersects with the ultrasound center plane can be obtained, which is the puncture target point. The puncture target point is displayed synchronously in the ultrasound image.

[0010] Confirm the focal length and ultrasound frequency, and adjust the focus of the ultrasound image to the depth of the puncture target point, thus obtaining a focal length equal to the depth of the puncture target point; set the input ultrasound frequency, and according to the formula: ST = cF / fD, the thickness of the ultrasound beam at the puncture target point, i.e., the thickness of the ultrasound slice, can be obtained. Based on the thickness of the ultrasound slice, a volumetric target area is set, and the projection of the puncture path through the volumetric target area onto the ultrasound center plane is set as the puncture target area. The puncture target area is simultaneously displayed in the ultrasound image for the operator to use as a reference for planning the puncture path;

[0011] Where c is the average velocity of ultrasound in human tissue; F is the focal length; f is the ultrasound frequency; and D is the probe aperture.

[0012] A simulated puncture needle path is generated. The distance of the puncture needle insertion is measured in real time by the ranging module and transmitted to the puncture needle trajectory generation module by the signal output unit. Then, the projection point of the puncture needle tip on the central plane during the process from the needle tip entering the skin to puncturing the target is generated. The image display module fits the real-time ultrasound image and displays it on the monitor as a real-time simulated puncture needle path.

[0013] The present invention also provides an ultrasound extraplane puncture visualization-assisted guidance system for implementing the ultrasound extraplane puncture visualization-assisted guidance method described above, including a clamping arm, a guidance module, a ranging module, a trajectory generation module and an image display module;

[0014] The clamping arm clamps onto the ultrasound probe, the guiding module is arranged on one side of the short axis of the ultrasound probe, and the guiding module is connected to the clamping arm;

[0015] The top of the guiding module is provided with multiple puncture needle passages, each with a different angle formed with the ultrasound center plane. The side wall of the guiding module is provided with a slot corresponding to each puncture needle passage. The ranging module is disposed in the slot. The signal transmission direction of the ranging module is parallel to the puncture needle passage. The signal emitted by the ranging module shines on a baffle and is received by the ranging module after being reflected by the baffle. The baffle is fixed on the puncture needle.

[0016] Preferably, the guide module is fan-shaped, and the puncture needle passages are arranged sequentially on the arc-shaped surface at the top of the guide module; the slots are arranged in a fan shape on the side wall of the guide module.

[0017] Preferably, the slot is a wedge-shaped slot, and the ranging module is inserted into the slot from the top.

[0018] Preferably, the ranging module includes a card box, which is inserted into the card slot from the top of the card slot. A limiting plate is provided on the top of the card box, and a ranging signal transmitting and receiving component is provided inside the card box. The ranging signal generated by the ranging signal transmitting and receiving component is emitted after passing through a reserved generating hole on the limiting plate.

[0019] Preferably, the ranging signal transmitting and receiving component transmits a laser signal, an infrared signal, or a microwave pulse signal.

[0020] Preferably, the clamping arm includes clamping arm A and clamping arm B, with a first end of clamping arm A movably connected to a first end of clamping arm B, and a second end of clamping arm A and a second end of clamping arm B being detachably connected via a connecting buckle.

[0021] Compared with the prior art, the beneficial technical effects of the present invention are as follows:

[0022] This invention utilizes the ultrasonic volume effect and sets a puncture target area based on the thickness of the ultrasonic slice, increasing the monitoring range of the puncture needle by the ultrasonic image during the puncture process. This relatively expands the safe area of ​​the puncture operation and solves the problem that providing only a puncture target point for out-of-plane puncture can lead to the needle tip being outside the target point and detached from the ultrasonic image monitoring during part of the surgical operation, which can easily increase surgical risks. At the same time, from the time the puncture needle enters the skin until it reaches the target, the projection point of the puncture needle tip on the central plane is output in real time on the ultrasonic image of the monitor to form a simulated puncture needle path. This realizes the visualization of the puncture needle tip trajectory simulation and solves the problem that the needle insertion path cannot be fully displayed in out-of-plane puncture because the ultrasonic section and the puncture needle are in a cross-sectional relationship. Attached Figure Description

[0023] The present invention will be further described below with reference to the accompanying drawings.

[0024] Figure 1 This is a flowchart of the ultrasound-guided extraplanar puncture visualization method of the present invention;

[0025] Figure 2 The present invention provides a schematic diagram simulating the puncture needle path by projecting the needle tip onto the ultrasonic center plane during the advancement of the puncture needle.

[0026] Figure 3 A schematic diagram provided by the present invention defines the projection of the puncture path through the volumetric target area onto the central plane as the puncture target area.

[0027] Figure 4 A schematic diagram showing the needle tip trajectory, puncture target point, and puncture target area of ​​the puncture needle provided by the present invention on an ultrasound image;

[0028] Figure 5 This is a schematic diagram of the ultrasonic extraplanar puncture visualization-assisted guidance system of the present invention;

[0029] Figure 6 This is a schematic diagram showing the positional relationship between the clamping arm, the guiding module, the ranging module, and the puncture needle of the present invention;

[0030] Figure 7 This is a schematic diagram of one side of the guiding module of the present invention;

[0031] Figure 8 This is a schematic diagram of the ranging module of the present invention;

[0032] Figure 9 This is a schematic diagram of another side of the guiding module of the present invention.

[0033] Explanation of reference numerals in the attached drawings: 1. Clamping arm; 101. Clamping arm A; 102. Clamping arm B; 103. Connecting buckle; 2. Guide module; 201. Puncture needle passage; 202. Slot; 3. Ranging module; 301. Card box; 302. Limiting plate; 303. Ranging signal transmitting and receiving assembly; 4. Ultrasonic probe; 5. Baffle; 6. Puncture needle. Detailed Implementation

[0034] To make the technical problems, technical solutions, and beneficial effects of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0035] like Figures 1 to 4 As shown in the figure, this embodiment discloses an ultrasound-guided extraplanar puncture visualization method, characterized in that the method includes the following steps:

[0036] (1) Image acquisition: real-time ultrasound image of the target object, which is the site to be punctured under ultrasound guidance;

[0037] In this embodiment, real-time ultrasound images of the target object are acquired to capture the real-time state of the target object, making it more accurate and reliable to determine the relative positional relationship between the target object and the puncture target point and puncture target area based on the ultrasound images.

[0038] Optionally, in some embodiments, an ultrasonic transducer is used to acquire real-time ultrasonic images of the target object.

[0039] Optionally, in some embodiments, the target signal is acquired by an image and video signal acquisition component and obtained through a connection method such as a serial port, USB port, Thunderbolt port, or HDMI port.

[0040] Optionally, in some embodiments, the target signal is converted from digital to analog (software decoding or hardware decoding) to obtain static and real-time dynamic ultrasound images.

[0041] (2) Set the puncture angle and confirm the puncture target point. Based on the position of the target object in the ultrasound image, select the puncture angle using an out-of-plane puncture method. After the puncture angle is determined, the point where the puncture path corresponding to that angle intersects with the ultrasound center plane can be obtained, which is the puncture target point. Figure 2 , 3 The T-point in the image is displayed synchronously on the client terminal via ultrasound.

[0042] The fixed puncture angle is selected based on the location of the target object in the ultrasound image. If the target object is located in the far field region of the ultrasound image, the angle between the puncture needle and the central plane of the ultrasound is small, and a puncture target point is formed in the far field of the ultrasound image. Conversely, if the target object is located in the near field region of the ultrasound image, the angle between the puncture needle and the central plane of the ultrasound is large, and a puncture target point is formed in the near field of the ultrasound image.

[0043] The determined puncture angle is based on the location of the puncture target and the spatial relationship of the real-time reference puncture target area. It is calculated by the operator based on a comprehensive calculation of various factors, including the sample volume and the two-dimensional anatomical structure through which the needle path passes. The embodiments of this application only provide a method and tool to facilitate the operator in implementing the puncture concept.

[0044] (3) Confirm the focal length and ultrasound frequency, adjust the ultrasound image focus to the depth of the puncture target point, thus obtaining a focal length equal to the depth of the puncture target point; set the input ultrasound frequency, and according to the formula: ST = cF / fD, the thickness of the ultrasound beam at the puncture target point, i.e., the thickness of the ultrasound slice, can be obtained. Based on the thickness of the ultrasound slice, set the volumetric target area, and set the projection of the puncture path through the volumetric target area onto the ultrasound center plane as the puncture target area ( Figure 3The area between the MN line segments (the region between the MN line segments), the puncture target area is displayed by synchronous ultrasound images on the client terminal, for the operator to use as a reference for planning the puncture path.

[0045] In the above formula, c is the average velocity of ultrasound in human tissue; F is the focal length; f is the ultrasound frequency; and D is the probe aperture.

[0046] Understandably, providing only one point where the puncture path intersects the central plane—the puncture target point—is insufficient for practical application. Ultrasound-guided punctures often require a certain amount of space for the puncture procedure. For example, when using an automated biopsy gun, the needle tip needs to be approximately 2 cm away from the target. Similarly, in radiofrequency ablation surgery, to ensure complete tumor inactivation, the needle needs to be withdrawn gradually. Therefore, relying solely on the puncture target point can lead to some procedures being outside the ultrasound image monitoring, increasing surgical risks. To address this issue, this application establishes a puncture target area. The puncture target area is based on the following: Because the ultrasound beam has a certain thickness, the ultrasound image is not an idealized two-dimensional section but rather an ultrasound slice containing all tissue echo information within the beam's thickness—the "volume effect" of ultrasound. The puncture target area essentially utilizes this "volume effect," reflecting the projected distance of the puncture path across the ultrasound slice on the central plane of the ultrasound image. The advantage of performing puncture within the puncture target area is that the ultrasound image within the puncture target area is formed by superimposing the echo information of all tissues within the corresponding ultrasound slice. At this time, the trajectory of the puncture needle tip within the puncture target area is entirely within the ultrasound slice. If, after observing the ultrasound image, there are no major blood vessels, nerves, or other important tissues that need to be avoided within the puncture target area, it indicates that the puncture operation within the puncture target area is safe. Therefore, this invention solves the problem that when the puncture path is planned solely based on the puncture target point, part of the puncture process is out of the ultrasound image monitoring range, thus reducing surgical risks.

[0047] (4) Generate a simulated puncture needle path. The distance of the puncture needle insertion is measured in real time by the ranging module and transmitted to the puncture needle trajectory generation module by the signal output unit. Then, the projection point of the puncture needle tip on the central plane during the process from the needle tip entering the skin to puncturing the target is compiled and generated. The image display module is fitted to the real-time ultrasound image and displayed on the monitor as a real-time simulated puncture needle path.

[0048] Understandably, the needle insertion process is dynamic and constantly changing. The corresponding ranging module measures the puncture distance in real time, and the signal processing unit converts this distance information into a corresponding signal. This signal is then transmitted by the signal output unit to the needle trajectory generation module, which compiles and generates the projection point of the needle tip on the central plane. The image display module then fits this projection onto the real-time ultrasound image. At this point, the monitor displays the simulated needle tip trajectory, the puncture target point, and the puncture target area (see...). Figure 4 ).

[0049] Optionally, in some embodiments, the corresponding wireless signal for distance information conversion in this application includes digitally encoded signals or Bluetooth and Wi-Fi, etc.

[0050] Optionally, in some embodiments, this application provides an ultrasound-guided extraplane puncture visualization method, which can be applied to a terminal, a server, or software running on a terminal or server. The receiving and compiling module is connected to or built into the client terminal, including but not limited to personal computers, ultrasound equipment terminals, and mobile communication terminals. The server can be an independent physical server, a server cluster or distributed system composed of multiple physical servers, or a cloud server providing basic cloud computing services such as cloud services, cloud databases, cloud computing, cloud functions, cloud storage, network services, cloud communication, middleware services, domain name services, security services, content delivery networks (CDN), and big data and artificial intelligence platforms.

[0051] like Figures 5 to 9 As shown, this embodiment also discloses an ultrasound extraplane puncture visualization-assisted guidance system for implementing the above-mentioned ultrasound extraplane puncture visualization-assisted guidance method. The system includes a clamping arm 1, a guidance module 2, a ranging module 3, a trajectory generation module, and an image display module.

[0052] The clamping arm 1 is clamped on the ultrasound probe 4. The clamping arm 1 includes clamping arm A101 and clamping arm B102. The first end of clamping arm A101 is movably connected to the first end of clamping arm B102. The second end of clamping arm A101 and the second end of clamping arm B102 are detachably connected by connecting buckle 103.

[0053] The guide module 2 is arranged on one side of the short axis of the ultrasound probe 4, and the guide module 2 is fixedly connected to the clamping arm B102 in the clamping arm 1.

[0054] The top of the guide module 2 is provided with multiple puncture needle passages 201, and the angle formed by each puncture needle passage 201 and the ultrasound center plane is different. On the side wall of the guide module 2, there are slots 202 at the positions corresponding to each puncture needle passage 201. The ranging module 3 is set in the slots 202. The signal transmission direction of the ranging module 3 is parallel to the puncture needle passage 201. The signal emitted by the ranging module 3 shines on the baffle 5 and is received by the ranging module 3 after being reflected by the baffle 5. The baffle 5 is fixed on the puncture needle 6.

[0055] In this embodiment, the guide module 2 is fan-shaped, and each puncture needle passage 201 is arranged sequentially on the arc-shaped surface at the top of the guide module 2; each slot 202 is arranged in a fan shape on the side wall of the guide module 2. In this embodiment, two puncture needle passages 201 are arranged on the guide module 2.

[0056] The puncture needle passage 201 works in conjunction with the puncture needle 6 to fix the puncture angle. The two puncture needle passages 201, which are closer to the ultrasound probe 4 and farther away from it, are used to guide the puncture ultrasound image to the far field and near field targets, respectively. That is, the puncture needle passage 201 closer to the ultrasound probe 4 has a smaller angle with the ultrasound center plane and forms a puncture target point in the far field of the ultrasound image, while the puncture needle passage 201 farther away from the ultrasound probe 4 has a larger angle with the ultrasound center plane and forms a puncture target point in the near field of the ultrasound image.

[0057] In this embodiment, the card slot 202 is a wedge-shaped slot, and the ranging module 3 is inserted into the card slot 202 from the top. Preferably, the ranging module 3 is an independently packaged structure, which is separate from the guide module 2 and detachable, which is beneficial for individual disinfection.

[0058] like Figure 9 As shown, the ranging module 3 includes a cartridge 301, which is inserted into the slot 202 from the top. A limiting plate 302 is provided on the top of the cartridge 301, abutting against the arc-shaped surface of the guide module 2. A ranging signal transmitting and receiving component 303 is provided inside the cartridge 301. This component mainly includes a signal transmitting unit, a signal receiving unit, and a signal processing unit. The ranging signal generated by the signal transmitting unit passes through a pre-drilled hole on the limiting plate 302 and is emitted. After being reflected by the baffle 5, it passes through the pre-drilled hole again on the limiting plate 302 and is received by the signal receiving unit. The signal processing unit converts the distance information into a corresponding signal, which is then transmitted by the signal output unit to the puncture needle trajectory generation module. Preferably, an indicator light and a power button can also be provided on the outer surface of the ranging module 3.

[0059] The ranging signal transmitting and receiving component 303 transmits laser signals, infrared signals, or microwave pulse signals. In this embodiment, the ranging signal transmitting and receiving component 303 transmits laser signals. The ranging signal transmitting and receiving component 303 mainly includes a main control circuit board, a laser transmitting and receiving unit, a signal processing unit, and a signal output unit. It functions to transmit and receive laser information, process laser reflection information, and transmit wireless signals containing distance information to the trajectory generation module and the image display module.

[0060] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. An ultrasound-guided extraplane puncture visualization system, used to realize an ultrasound-guided extraplane puncture visualization system, characterized in that: The terminal performs the following steps: Image acquisition: Acquire real-time ultrasound images of the target object, which is the site to be punctured under ultrasound guidance; Set puncture angle to confirm puncture target point: Based on the position of the target object in the ultrasound image, select the puncture angle using an out-of-plane puncture method. After the puncture angle is determined, the point where the puncture path corresponding to the angle intersects with the ultrasound center plane can be obtained, which is the puncture target point. The puncture target point is displayed synchronously in the ultrasound image. Confirm the focal length and ultrasound frequency, and adjust the ultrasound image focus to the depth of the puncture target point to obtain a focal length equal to the depth of the puncture target point. Set the input ultrasound frequency, and according to the formula: ST=cF / fD, the thickness of the ultrasound beam at the puncture target point, i.e., the thickness of the ultrasound slice, can be obtained. Based on the thickness of the ultrasound slice, set a volumetric target area. The projection of the puncture path through the volumetric target area onto the ultrasound center plane is set as the puncture target area. The trajectory of the puncture needle tip within the puncture target area is entirely within the ultrasound slice. The puncture target area is simultaneously displayed with ultrasound images for the operator to use as a reference for planning the puncture path. Where c is the average velocity of ultrasound in human tissue; F is the focal length; f is the ultrasound frequency; and D is the probe aperture. A simulated puncture needle path is generated. The distance of the puncture needle insertion is measured in real time by the ranging module and transmitted to the puncture needle trajectory generation module by the signal output unit. Then, the projection point of the puncture needle tip on the central plane during the process from the needle tip entering the skin to puncturing the target is generated. The image display module fits the real-time ultrasound image and displays it on the monitor as a real-time simulated puncture needle path. The aforementioned ultrasound extraplane puncture visualization-assisted guidance system includes a clamping arm (1), a guidance module (2), a ranging module (3), a trajectory generation module, and an image display module; The clamping arm (1) is clamped on the ultrasonic probe (4), the guiding module (2) is arranged on one side of the short axis of the ultrasonic probe (4), and the guiding module (2) is connected to the clamping arm (1). The top of the guide module (2) is provided with multiple puncture needle passages (201), and the angle formed by each puncture needle passage (201) and the ultrasound center plane is different. The side wall of the guide module (2) is provided with a slot (202) at the position corresponding to each puncture needle passage (201). The ranging module (3) is disposed in the slot (202). The signal transmission direction of the ranging module (3) is parallel to the puncture needle passage (201). The signal emitted by the ranging module (3) is irradiated on the baffle (5) and received by the ranging module (3) after being reflected by the baffle (5). The baffle (5) is fixed on the puncture needle (6). The guide module (2) is fan-shaped, and each of the puncture needle passages (201) is arranged sequentially on the arc-shaped surface at the top of the guide module (2); each of the slots (202) is fan-shaped and correspondingly arranged on the side wall of the guide module (2); The slot (202) is a wedge-shaped slot, and the ranging module (3) is inserted into the slot (202) from the top of the slot (202); The ranging module (3) includes a card box (301), which is inserted into the card slot (202) from the top. A limiting plate (302) is provided on the top of the card box (301). A ranging signal transmitting and receiving component (303) is provided inside the card box (301). The ranging signal generated by the ranging signal transmitting and receiving component (303) is emitted after passing through the reserved generating hole on the limiting plate (302).

2. The ultrasound-guided extraplanar puncture visualization system according to claim 1, characterized in that: The ranging signal transmitting and receiving component (303) transmits laser signals, infrared signals, or microwave pulse signals.

3. The ultrasound-guided extraplanar puncture visualization system according to claim 1, characterized in that: The clamping arm (1) includes clamping arm A (101) and clamping arm B (102). The first end of clamping arm A (101) is movably connected to the first end of clamping arm B (102). The second end of clamping arm A (101) and the second end of clamping arm B (102) are detachably connected by a connecting buckle (103).

Images