A mechanical sweep real-time three-dimensional insonification ultrasound imaging system and process

Abstract

The application discloses a mechanical swing scanning real-time three-dimensional built-in ultrasonic imaging system and process, and the ultrasonic imaging system comprises an operation handle, a built-in catheter, an imaging unit and a rotating power device. In one aspect, the inner core reciprocates and swings within the width of the view window to replace 360-degree rotation, focuses on the target area in front to realize real-time or quasi-real-time three-dimensional images, and effectively solves the problems of poor spatial perception of traditional two-dimensional imaging, low frame rate of full-circle scanning and data redundancy. In another aspect, based on the mechanical decoupling design of the puncture needle and the inner core, the stability of the probe swing and the three-dimensional reconstruction accuracy are ensured, the interference of imaging motion on puncture operation is avoided, the deficiency of poor adaptability of the complex rotating structure is overcome, and the intervention navigation efficiency is significantly improved.

Description

Technical Field

[0001] This invention belongs to the field of medical ultrasound imaging technology, specifically relating to a mechanically oscillating real-time three-dimensional implantable ultrasound imaging system, and also to a mechanically oscillating real-time three-dimensional implantable ultrasound imaging process. Background Technology

[0002] Interventional ultrasound is a commonly used real-time image-guided technology in minimally invasive clinical diagnosis and treatment, and is widely used in procedures such as puncture, biopsy, ablation, drainage, and drug delivery.

[0003] Currently, the mainstream interventional ultrasound products in the industry mainly include extracorporeal ultrasound guidance systems, intracavitary ultrasound systems, endoscopic ultrasound systems, and intravascular ultrasound systems. Among them, extracorporeal ultrasound guidance systems usually consist of a surface ultrasound probe, an ultrasound host, and a display device. Doctors perform puncture or treatment operations under the guidance of two-dimensional images acquired by the surface probe. Its advantages are high maturity and convenient operation. However, the imaging angle is limited by the surface position, and the display effect of deep tissues or complex anatomical areas is easily affected by tissue attenuation, bone obstruction, gas interference, and imaging angle. Intracavitary ultrasound and endoscopic ultrasound, on the other hand, improve the local imaging quality by inserting the ultrasound probe into natural cavities or the tip of the endoscope, making the imaging unit closer to the target area. Endoscopic ultrasound systems typically include an endoscope body, a front-end ultrasound probe, a working channel, a puncture needle, or a treatment instrument. They enable imaging guidance and interventional procedures near the digestive tract, respiratory tract, or other cavities. Their overall size and entry path are limited by the endoscope structure, making them primarily suitable for interventional scenarios related to specific cavities. Intravascular ultrasound and other catheter-based ultrasound products typically place a miniature ultrasound transducer at the distal end of the catheter, entering the body through blood vessels or other cavities to achieve local imaging. Existing intravascular ultrasound products mainly include two types: mechanically rotating and electronically phased array. Mechanically rotating catheters typically consist of an outer sheath, a proximal drive unit, a flexible drive shaft or torque shaft, a distal miniature unit transducer, and electrical connections. The typical connection is as follows: the proximal motor outputs rotational motion, which is transmitted to the distal transducer via a slender drive shaft, causing a single transducer to rotate continuously around the catheter axis. During rotation, the transducer sequentially emits ultrasound in different circumferential directions and receives echoes. The host computer reconstructs these echo data to form a circumferential cross-sectional image. The advantages of this type of structure are that it requires fewer transducer units at the distal end and the front-end structure is relatively straightforward, thus it has been widely used in early and existing clinical systems. Its disadvantages are also quite typical: since distal imaging relies on a rotary transmission chain, catheter coaxiality, shaft wobble, rotation uniformity, and long-term reliability all affect image quality. Furthermore, the internal space of the catheter must simultaneously accommodate the transmission shaft, cables, and protective structures, compressing the space available for other functional modules. If it is desired to add larger intervention channels, additional sensing units, or more complex scanning mechanisms within the same device, traditional mechanical rotary structures face significant space constraints. Electronic phased array systems typically arrange multiple miniature array elements in a circumferential or annular region at the distal end of the catheter. Each element is fixed and does not rotate, forming an image by electronically stimulating and receiving signals in turn. This approach eliminates high-speed rotating transmission components, theoretically reducing some mechanical instability factors and improving system stability under certain operating conditions.The industry generally regards it as another mainstream IVUS route alongside mechanical rotary type. However, the electronic phased array solution places higher demands on micro-packaging, element consistency, channel interconnection, front-end wiring and system driving. Especially when the diameter of the instrument is strictly limited, the increase in the number of elements often means a simultaneous increase in interconnection complexity and packaging difficulty. If the device not only undertakes imaging tasks, but also needs to take into account the passage of other instruments, the layout of functional modules, or more complex spatial scanning capabilities, its far-end space allocation will be more strained. Therefore, although the electronic phased array route has potential in electronic scanning, it is still quite difficult to implement in ultra-fine, micro-sized, and multifunctional integrated implantable instruments.

[0004] However, traditional interventional ultrasound primarily relies on two-dimensional ultrasound images for guidance, displaying the positional relationship between the target tissue, interventional instruments, and surrounding anatomical structures through a fixed or dynamic cross-section. Interventional procedures are essentially a three-dimensional process of instrument positioning and path control. The position, orientation, depth, and relationship with the target area and adjacent important tissues of puncture needles, catheters, guidewires, ablation needles, or other therapeutic instruments within the body all possess three-dimensional characteristics. Traditional two-dimensional ultrasound can only display information within a single cross-section. When the instrument or target area deviates from the imaging plane, the operator needs to rely on experience to infer spatial relationships, which can easily lead to problems such as discontinuous needle tip display, difficulty in determining the instrument path, or incomplete understanding of target boundaries. Therefore, in complex interventional procedures, three-dimensional ultrasound can provide more complete spatial information, which is beneficial for improving the positioning accuracy, operational intuitiveness, and safety during the intervention process. There are two main types of real-time 3D ultrasound implementation methods. The first type is two-dimensional array electronic scanning, which uses a two-dimensional array transducer to perform electronic focusing and scanning in multiple directions to directly acquire volume data. The second type is mechanical scanning to obtain continuous two-dimensional cross-sections and then perform 3D reconstruction. In conventional large-sized probes, two-dimensional array is an important approach, but area array probes are expensive, and in interventional ultrasound, catheters are mostly disposable consumables. However, in catheter-type, needle-type, and slender implantable devices, due to limited front-end area, limited interconnection resources, and difficulties in array element packaging, the mechanical scanning approach has long been of practical significance in engineering.

[0005] In short, existing interventional ultrasound techniques have the following shortcomings: 1) Traditional ultrasound imaging is mainly based on two-dimensional imaging, which is difficult to fully meet the needs of real-time spatial positioning and three-dimensional visualization in complex interventional procedures. When the instrument or target deviates from the two-dimensional imaging plane, the operator needs to rely on experience to make spatial judgments, thus failing to accurately perceive the three-dimensional spatial relationship between the instrument tip and the surrounding key anatomical structures (such as blood vessel walls and nerve bundles). This significantly increases the surgical risks such as tissue injury and puncture deviation, while also prolonging the operation time and increasing the operator's cognitive load.

[0006] 2) The most common mechanical scanning methods in existing catheter-based or intravascular ultrasound are 360° rotation scanning. This method is suitable for circumferential cross-sectional observation of vascular or cavity structures. However, in interventional surgery, operators usually pay more attention to local spatial information in front of the instrument or near the target area. 360° rotation scanning may have problems such as low effective field of view utilization and scattered scanning resources, which directly leads to a decrease in the imaging frame rate of the target area in front, a large amount of data redundancy and real-time feedback delay. It is difficult to support high-precision forward navigation and rapid dynamic tracking, which limits its application effectiveness in complex non-vascular interventional scenarios.

[0007] 3) Complete rotational scanning usually requires a rotating drive shaft, slip ring, or complex rotational connection structure, which places high demands on the transmission, wiring, and sealing within slender implantable devices. It is also unsuitable for endoscopic or implantable ultrasound structures with fixed imaging windows. Therefore, there is an urgent need to explore new scanning mechanisms that do not require overall mechanical rotation (such as electronic phased array scanning, microelectromechanical system galvanometers, or acoustic metamaterial beam deflection) to simplify the internal structure of the device, reduce the outer diameter, and achieve flexible forward or fan-shaped three-dimensional imaging, thereby improving the reliability and clinical applicability of the system. Summary of the Invention

[0008] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide an improved mechanical oscillating real-time three-dimensional implantable ultrasound imaging system.

[0009] The present invention also relates to a mechanically oscillating real-time three-dimensional implantation ultrasonic imaging process.

[0010] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows: A mechanically oscillating real-time three-dimensional implantable ultrasound imaging system includes an operating handle, an implantation catheter, an imaging unit, and a rotary actuator. The implantation catheter includes an outer catheter, an inner core, and a three-way connector. The three-way connector includes a straight tube forming an implantation cavity and an insertion cannula communicating with the implantation cavity from one side of the straight tube. The straight tube connects the proximal end of the outer catheter to the operating handle, and the inner core connects to the rotary actuator. A viewing window is provided on one side of the distal end of the outer catheter. The insertion cannula is a puncture cannula, and an avoidance notch is formed on the inner core, wherein the avoidance notch and the inner wall of the outer catheter form a puncture channel. The imaging unit includes a device located at the distal end of the inner core and connected to the viewing window. The aligned ultrasound probe, the self-puncture tube, and the puncture channel are sequentially inserted into and exit through the viewing window of the puncture needle. The inner core and the puncture needle are mechanically decoupled by relative rotational support and avoidance. The inner core reciprocates around its own axis within the wide range of the viewing window. The ultrasound probe continuously changes space within the wide range of the viewing window based on the two-dimensional imaging plane and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images. The puncture needle exits through the puncture channel from the viewing window, and the exiting part is an adjustable bent needle tip. The adjustable bent needle tip is bent or oscillated based on the mechanical decoupling relative to the inner core.

[0011] Preferably, mechanical decoupling is a technique that uses structural design or control strategies to weaken or eliminate the coupling relationship between mutually influencing components or degrees of freedom in a mechanical system, thereby achieving independent motion and control.

[0012] Preferably, the inner core is rod-shaped, with its axis coinciding with the axis of the outer conduit. This coincidence of axes ensures that the rotation of the inner core maintains the same standard, which is more conducive to scanning by the synchronously moving ultrasound probe, thereby improving the accuracy of the three-dimensional image.

[0013] According to a specific embodiment and preferred aspect of the present invention, the clearance notch is a recessed groove from the outside in, wherein the two ends of the groove form guide ramps, namely an insertion ramp and an exit ramp, respectively. The puncture needle passes through the puncture channel and exits through the viewing window based on the line contact or surface contact of the insertion ramp and the exit ramp. The layout of the guide ramps not only maintains the same angle for the insertion and exit of the puncture needle, but also maintains contact restriction of the inner core based on contact to assist the rotation of the inner core.

[0014] Preferably, the inner core's own axis is used as the rotation center line, and the relative rotational support with respect to the puncture needle is used as the motion reference. Driven by the rotational power unit, the ultrasound probe reciprocates within the wide range of the viewing window based on the reference, so that the ultrasound probe can obtain and receive echo signals under the same standard, thereby more accurately assisting in imaging.

[0015] In some specific embodiments, the insertion angle of the puncture tube is consistent with the guide angle of the insertion ramp; the exit ramp is positioned close to the ultrasound probe and is located within the window axis layout area, wherein the exit curved section of the puncture needle is located within the window axis layout area and exits in accordance with the exit ramp. Due to the angle limitation, the insertion and exit angles of the puncture needle are controllable, and the adjustable bend increases the puncture working range while also avoiding motion interference between the puncture needle and the window (in short, the puncture-assisted imaging of the puncture needle will not be affected by the window).

[0016] According to a specific embodiment and preferred aspect of the present invention, an ultrasonic probe is used to emit ultrasonic waves and receive echo signals, wherein two-dimensional cross-sectional imaging is achieved in the axially correlated plane of the inner core through array element electronic scanning; and two-dimensional cross-sectional data at different angular positions are acquired under the mechanical sweeping action of the inner core to achieve real-time or near-real-time three-dimensional imaging. In short, the ultrasonic probe employs a miniature phased array ultrasonic transducer, which is fixed at the distal end of the inner core, and its material includes an array of piezoelectric transducer elements and a protective encapsulation structure. The array of piezoelectric transducer elements can be made of piezoelectric ceramics, piezoelectric composite materials, or single-crystal piezoelectric materials, and the exterior is encapsulated with an insulating and biocompatible material.

[0017] According to another specific embodiment and preferred aspect of the invention, the distal end of the external catheter is rounded or conical. This distal shape not only facilitates catheter insertion but also reduces the probability of distal-end injury.

[0018] According to another specific embodiment and preferred aspect of the invention, the viewing window is located near the rounded or conical distal end and extends along the axial direction of the external conduit. This provides a consistent reference for ultrasound scanning, ensuring that changes in position do not affect the accuracy of the final imaging.

[0019] Furthermore, the rotary power unit includes a rotary motor and a transmission assembly. The transmission assembly is fixedly connected to the proximal end of the inner core, and the inner core reciprocates under the drive of the rotary motor. The transmission assembly includes a crank, a connecting rod, and a rocker arm. The crank is located inside the operating handle and is fixedly or coaxially connected to the output shaft of the rotary motor. The connecting rod is located between the crank and the rocker arm, with its two ends rotatably connected to the crank and the rocker arm, respectively. The rocker arm is fixedly connected to the proximal end of the inner core. This crank-connecting rod transmission method converts rotation into reciprocating oscillation.

[0020] Another technical solution of the present invention is: a mechanically oscillating real-time three-dimensional implantable ultrasound imaging process, which adopts the above-mentioned mechanically oscillating real-time three-dimensional implantable ultrasound imaging system and includes the following steps: S1. Placement and Positioning The catheter is inserted into the target area from the distal end, and a puncture needle is used to locate the target area. S2. Scanning Imaging The inner core is driven by a rotary power unit to reciprocate around its own axis within the wide range of the viewing window. The inner core and the puncture needle are mechanically decoupled. At the same time, the inner core and the puncture needle rotate relative to each other for support and avoidance. Meanwhile, the ultrasound probe fixed at the far end of the inner core scans synchronously. The ultrasound probe is based on the continuous spatial change of the two-dimensional imaging plane within the wide range of the viewing window, and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images.

[0021] Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art: Current interventional ultrasound imaging primarily relies on two-dimensional imaging, which is insufficient to meet the demands for real-time spatial positioning and three-dimensional visualization in complex interventional procedures. When instruments or targets deviate from the two-dimensional imaging plane, operators must rely on experience for spatial judgment, making it difficult to accurately perceive the three-dimensional spatial relationship between the instrument tip and surrounding key anatomical structures (such as blood vessel walls and nerve bundles). This significantly increases the surgical risks of tissue injury and puncture deviation, while also prolonging the procedure time and increasing the operator's cognitive load. Furthermore, the mechanical scanning methods commonly used in current catheter-based or intravascular ultrasound are mostly 360° rotational scanning. While this method is suitable for circumferential cross-sectional observation of luminal structures such as blood vessels or cavities, operators in interventional procedures typically focus more on local spatial information in front of the instrument or near the target area. 360° rotational scanning may suffer from low effective field-of-view utilization and dispersed scanning resources, directly leading to reduced imaging frame rate for the target area, large data redundancy, and real-time feedback delays. This makes it difficult to support high-precision forward navigation and rapid dynamic tracking, limiting its application effectiveness in complex non-vascular interventional scenarios. Finally, complete rotational scanning usually requires a rotation drive shaft, slip ring, or complex rotational connection structure for the transmission within slender implanted instruments. The present invention addresses the shortcomings of traditional methods, such as high requirements for wiring and sealing, and unsuitability for endoscopic or implantable ultrasound structures with fixed imaging windows. This invention, based on the overall structural design of a mechanically oscillating real-time three-dimensional implantable ultrasound imaging system, cleverly solves these shortcomings. Using this ultrasound imaging system, a rotary actuator drives the inner core to reciprocate around its own axis within the wide range of the viewing window. The ultrasound probe continuously changes spatially within the wide range of the viewing window based on the two-dimensional imaging plane, and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images. Simultaneously, based on the adjustable bending tip of the puncture needle… This invention achieves mechanical decoupling between the protruding part of the puncture needle and the inner core, allowing for bending or swinging to assist imaging. Therefore, on one hand, the inner core reciprocates within the wide viewing window, replacing 360° rotation, to focus on the target area and achieve real-time or near-real-time 3D images. This effectively solves the problems of poor spatial perception, low frame rate, and data redundancy in traditional 2D imaging. On the other hand, the mechanical decoupling design between the puncture needle and the inner core ensures both the stability of the probe's swing and the accuracy of 3D reconstruction, while avoiding interference from imaging motion on the puncture operation. These complementary approaches overcome the poor adaptability of complex rotating structures, significantly improving interventional navigation efficiency. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the mechanical oscillating real-time three-dimensional implantable ultrasound imaging system of the present invention; Figure 2 for Figure 1 A structural decomposition diagram; Figure 3 for Figure 1Front view diagram; Figure 4 for Figure 3 A top-down view; Figure 5 for Figure 4 Schematic diagram of the AA section; The components are as follows: 1. Operating handle; 10. Upper housing; 11. Lower housing; 2. Insertion catheter; 20. External catheter; 200. Viewing window; 21. Inner core; 210. Avoidance notch; a. Groove; s. Insertion ramp; q. Exit ramp; 22. T-tube; 220. Straight tube; 221. Insertion cannula; 3. Imaging unit; 30. Ultrasonic probe; 31. Puncture needle; 4. Rotary power unit; 40. Rotary motor; 41. Transmission assembly; 410. Crank; 411. Connecting rod; 412. Rocker arm. Detailed Implementation

[0023] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0024] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0025] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0026] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0027] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0028] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0029] like Figures 1 to 5 As shown, the mechanical oscillating real-time three-dimensional implantable ultrasound imaging system of this embodiment includes an operating handle 1, an implantation catheter 2, an imaging unit 3, and a rotary power unit 4. The operating handle 1 is formed by the docking of two housings (upper housing 10 and lower housing 11). The implantation catheter 2 includes an outer catheter 20, an inner core 21, and a three-way tube 22. The imaging unit 3 includes an ultrasound probe 30 and a puncture needle 31. The rotary power unit 4 includes a rotary motor 40 and a transmission assembly 41.

[0030] Specifically, the external catheter 20 is mainly used to provide a path for the insertion end to enter the body, and to support, protect and guide the internal core 21 and ultrasound probe 30; at the same time, the external catheter 20 is provided with a viewing window 200 (or ultrasound imaging window) to provide an ultrasound transmission and reception path for the ultrasound probe 30 of the internal core 21.

[0031] In some specific embodiments, the outer catheter 20 and the inner core 21 are co-located, with the proximal end connected to the three-way tube 22 and the distal end tapered (or rounded). This distal shape facilitates catheter insertion and reduces the probability of distal-end damage. Simultaneously, the viewing window 200 is located near the tapered distal end and extends along the axis of the outer catheter 20. This provides a consistent reference for ultrasound scanning, ensuring that positional changes do not affect the final imaging accuracy. Furthermore, the outer catheter 20 can be made of medical-grade metals or polymers with sufficient strength and biocompatibility, such as stainless steel, nickel-titanium alloy, polyimide, Pebax, or polytetrafluoroethylene. A composite structure can also be used, and the viewing window area can be formed using a thin-walled structure or acoustically transparent material that minimizes the impact on ultrasound propagation. The inner core 21 is located inside the outer conduit 20 and extends axially, with its distal end located in the corresponding area of ​​the viewing window 200. In this example, the inner core 21 is rod-shaped, with its axis coinciding with the axis of the outer conduit 20. The inner core 21 is the main carrier structure of the insertion end, and it can reciprocate under the action of the rotary power unit 4, especially the angular oscillation of the distal imaging segment, thereby driving the ultrasonic probe 30 to scan and provide continuous cross-sectional data for real-time three-dimensional imaging. The ultrasonic probe 30 is positioned at the distal end of the inner core 21, ensuring that it always corresponds to the viewing window 200 for imaging during the oscillation process. The proximal end of the inner core 21 is connected to the rotary power unit 4 inside the operating handle 1, thus enabling the oscillation. The inner core 21 is made of medical polymer materials, metal materials, or composite materials with a certain strength, such as PEEK, polyimide, reinforced Pebax, stainless steel thin-walled tube, nickel-titanium alloy tube, etc.; if necessary, a composite structure of polymer outer layer and metal reinforcement layer can also be used to balance the support required for oscillation scanning and the fine diameter required for the insertion process. The three-way tube 22 includes a straight tube 220 forming an insertion cavity inside, and an insertion cannula 221 communicating with the insertion cavity from one side of the straight tube 220. The straight tube 220 connects the proximal end of the external catheter 20 to the operating handle 1.

[0032] In this example, the cannula 221 is a puncture tube, with an avoidance notch 210 formed on the inner core 21. The avoidance notch 210 and the inner wall of the outer catheter 20 form a puncture channel. Specifically, the avoidance notch 210 is a groove a recessed from the outside to the inside, with guide ramps formed at both ends of the groove a, namely an insertion ramp s and an exit ramp q. The puncture needle 31 passes through the puncture channel and exits through the viewing window 200 based on the line contact or surface contact of the insertion ramp s and the exit ramp q. The insertion angle of the puncture tube is consistent with the guide angle of the insertion ramp s. The exit ramp q is set close to the ultrasound probe 31 and is located within the axial layout area of ​​the viewing window 200. The exiting curved section of the puncture needle 31 is located within the axial layout area of ​​the viewing window 200 and exits in contact with the exit ramp q. The angle limitation allows for controllable insertion and exit angles of the puncture needle, and the adjustable bending increases the puncture working range while avoiding motion interference between the puncture needle and the viewing window (in short, the puncture-assisted imaging of the puncture needle will not be affected by the viewing window).

[0033] In some specific embodiments, the ultrasound probe 30 is positioned at the distal end of the inner core 21 and aligned with the viewing window 200. The puncture needle 31 is inserted sequentially through the puncture tube and puncture channel and exits through the viewing window 200. The inner core 21 and the puncture needle 31 are mechanically decoupled through relative rotational support and avoidance. The inner core 21 reciprocates within a wide range of the viewing window 200 around its own axis. The ultrasound probe 30 continuously changes spatially within the wide range of the viewing window 200 based on the two-dimensional imaging plane, and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images. The exit portion of the puncture needle 31 is an adjustable bent needle tip 31a, which is bent or oscillated based on the mechanical decoupling relative to the inner core 21. Specifically, mechanical decoupling is a technique that weakens or eliminates the coupling relationship between mutually influencing components or degrees of freedom in a mechanical system through structural design or control strategies, achieving independent motion and control. Meanwhile, with the axis of the inner core 21 as the rotation center line and the relative rotation support with the puncture needle 31 as the motion reference, the ultrasound probe 30 reciprocates within the wide range of the viewing window 200 based on the reference under the drive of the rotary power unit 4, so that the ultrasound probe 30 can obtain and receive echo signals under the same standard, thereby more accurately assisting imaging.

[0034] In this example, the ultrasonic probe 30 is used to emit ultrasonic waves and receive echo signals. Two-dimensional cross-sectional imaging is achieved in the axially related plane of the inner core 21 through array element electronic scanning; and two-dimensional cross-sectional data at different angular positions are acquired under the mechanical sweeping action of the inner core 21 to achieve real-time or near-real-time three-dimensional imaging. In short, the ultrasonic probe 30 employs a miniature phased array ultrasonic transducer, which is fixed to the distal end of the inner core 21. Its materials include an array of piezoelectric transducer elements and a protective encapsulation structure. The array of piezoelectric transducer elements can be made of piezoelectric ceramics, piezoelectric composite materials, or single-crystal piezoelectric materials, and the exterior is encapsulated with an insulating and biocompatible material. The puncture needle 31 is a commonly used adjustable-bend puncture needle in the art and is directly purchased externally.

[0035] In some specific embodiments, the transmission assembly 41 is fixedly connected to the proximal end of the inner core 21, and the inner core 21 reciprocates under the drive of the rotary motor 40. The transmission assembly 41 includes a crank 410, a connecting rod 411, and a rocker arm 412. The crank 410 is disposed inside the operating handle 1 and is fixedly or coaxially connected to the output shaft 400 of the rotary motor 40. The connecting rod is disposed between the crank 410 and the rocker arm 412, and its two ends are rotatably connected to the crank 410 and the rocker arm 412, respectively. The rocker arm 412 is fixedly connected to the proximal end of the inner core 21. The crank-connecting rod transmission method converts rotation into reciprocating oscillation.

[0036] In summary, this embodiment achieves implantable real-time three-dimensional interventional ultrasound imaging through two-dimensional phased array imaging and rapid mechanical scanning. The specific operation is as follows: S1. Placement and Positioning The catheter 2 is inserted into the target area from the distal end, and the puncture needle 31 is used to puncture and locate the target area. S2. Scanning Imaging Driven by the rotary power unit 4, the inner core 21 reciprocates around its own axis within the wide range of the viewing window 200, and the inner core 21 and the puncture needle 31 are mechanically decoupled. At the same time, the inner core 21 and the puncture needle 31 rotate relative to each other for support and avoidance. At this time, the ultrasound probe 30 fixed at the distal end of the inner core 21 scans synchronously. The ultrasound probe 30 continuously changes in space within the wide range of the viewing window 200 based on the two-dimensional imaging plane, and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or quasi-real-time three-dimensional images.

[0037] In summary, compared with existing technologies, the patented technical solution has the following advantages: 1. By reciprocating within the wide viewing window of the inner core instead of 360° rotation, real-time or near-real-time 3D images are achieved by focusing on the target area in front. This is not only suitable for observing the area in front of the instrument or a local target area during intervention, but also effectively solves the problems of poor spatial perception, low frame rate, and data redundancy in traditional 2D imaging. 2. Based on the mechanical decoupling design of the puncture needle and the inner core, the stability of the probe's oscillation and the accuracy of 3D reconstruction are ensured, while avoiding interference from imaging motion on the puncture operation. This mutually overcomes the shortcomings of poor adaptability of complex rotating structures, significantly improving interventional navigation efficiency. Simultaneously, puncture further enhances the spatial positioning capability during the intervention process. 3. Because the inner core is rod-shaped, with its axis coinciding with the axis of the external catheter, the rotation of the inner core maintains the same standard, which is more conducive to scanning by the ultrasound probe moving synchronously with it, thereby improving the accuracy of the 3D image. 4. A guide ramp is used. The layout not only ensures the same angle for needle insertion and exit, but also maintains contact with the inner core to assist its rotation. Simultaneously, using the inner core's own axis as the rotation centerline and maintaining relative rotational support with the needle as the motion reference, the ultrasound probe reciprocates within a wide range of the viewing window under the drive of the rotary actuator. This allows the ultrasound probe to acquire and receive echo signals under the same standard, thus providing more accurate imaging assistance. 5. The angle limitation allows for controllable needle insertion and exit angles, and the adjustable bend increases the puncture working range while avoiding motion interference between the needle and the viewing window (in short, the viewing window will not affect the needle's puncture-assisted imaging). 6. The distal shape not only facilitates catheter insertion but also reduces the probability of distal damage; the viewing window is located near the rounded or conical distal end and extends along the axis of the external catheter. 7. Provides the same reference for ultrasound scanning, and the final imaging accuracy will not be affected by changes in position; 8. Adopts a crank-connecting rod transmission method to convert rotation into reciprocating oscillation, which is simple and stable; 9. Through the integrated design of imaging and interventional structure, it is beneficial to improve the consistency between imaging path and interventional path, thereby facilitating subsequent interventional operations.

[0038] The present invention has been described in detail above, with the aim of enabling those skilled in the art to understand and implement the invention. However, this description should not be construed as limiting the scope of protection of the invention. All equivalent changes or modifications made in accordance with the spirit and essence of the invention should be included within the scope of protection of the invention.

Claims

1. A mechanically oscillating real-time three-dimensional implantable ultrasound imaging system, comprising an operating handle, an implantation catheter, an imaging unit, and a rotary actuator, wherein the implantation catheter includes an outer catheter, an inner core, and a three-way connector, wherein the three-way connector includes a straight tube forming an implantation cavity internally, and an insertion tube communicating with the implantation cavity from one side of the straight tube, the straight tube connecting the proximal end of the outer catheter to the operating handle, and the inner core connecting to the rotary actuator, characterized in that: A viewing window is provided on one side of the distal end of the external catheter. The cannula is a puncture tube with an avoidance notch formed on the inner core. The avoidance notch and the inner wall of the external catheter form a puncture channel. The imaging unit includes an ultrasound probe located at the distal end of the inner core and aligned with the viewing window, a puncture needle that enters sequentially from the puncture tube and the puncture channel and exits through the viewing window, and a mechanical decoupling between the inner core and the puncture needle through relative rotational support and avoidance. The inner core reciprocates around its own axis within the wide range of the viewing window. The ultrasound probe continuously changes the space of the two-dimensional imaging plane within the wide range of the viewing window and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images. The puncture needle exits through the puncture channel from the viewing window, and the exiting part is an adjustable bent needle tip. The adjustable bent needle tip is bent or oscillating based on the mechanical decoupling relative to the inner core.

2. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 1, characterized in that: The inner core is rod-shaped, and the axis of the rod coincides with the axis of the outer conduit.

3. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 1 or 2, characterized in that: The clearance is a groove that is concave from the outside to the inside. The two ends of the groove form guide ramps, which are respectively the entry ramp and the exit ramp. The puncture needle passes through the puncture channel and exits through the window based on the line contact or surface contact of the entry ramp and the exit ramp.

4. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 3, characterized in that: With the inner core's own axis as the rotation center line and maintaining relative rotational support with the puncture needle as the motion reference, the ultrasound probe reciprocates within the wide range of the viewing window under the drive of the rotary power unit.

5. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 3, characterized in that: The insertion angle of the puncture tube is consistent with the guiding angle of the insertion ramp; the exit ramp is set close to the ultrasound probe and is located within the window axis layout area, wherein the exit curved section of the puncture needle is located within the window axis layout area and is inserted into the exit ramp.

6. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 1, characterized in that: The ultrasonic probe is used to emit ultrasonic waves and receive echo signals. It achieves two-dimensional cross-sectional imaging in the axially related plane of the inner core through array element electronic scanning; and acquires two-dimensional cross-sectional data at different angle positions under the mechanical sweeping action of the inner core to achieve real-time or near-real-time three-dimensional imaging.

7. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 6, characterized in that: The ultrasonic probe is fixed at the far end of the inner core and is made of an array of piezoelectric transducers and a protective encapsulation structure. The array of piezoelectric transducers can be made of piezoelectric ceramics, piezoelectric composite materials or single-crystal piezoelectric materials, and the outside is made of insulating and biocompatible encapsulation material.

8. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 1, characterized in that: The distal end of the external conduit is rounded or conical; and / or, the viewing window is close to the rounded or conical distal end and extends along the axial direction of the external conduit.

9. The mechanically oscillating real-time three-dimensional implantable ultrasound imaging system according to claim 1, characterized in that: The rotary power unit includes a rotary motor and a transmission assembly, wherein the transmission assembly includes a crank, a connecting rod, and a rocker arm. The crank is located inside the operating handle and is fixedly or coaxially connected to the output shaft of the rotary motor. The connecting rod is located between the crank and the rocker arm, and its two ends are rotatably connected to the crank and the rocker arm, respectively. The rocker arm is fixedly connected to the proximal end of the inner core.

10. A mechanically oscillating real-time three-dimensional implantable ultrasound imaging process, characterized in that: It employs the mechanically oscillating real-time three-dimensional implantable ultrasound imaging system as described in claims 1 to 9, and includes the following steps: S1. Placement and Positioning The catheter is inserted into the target area from the distal end, and a puncture needle is used to puncture and locate the target area. S2. Scanning Imaging The inner core is driven by a rotary power unit to reciprocate around its own axis within the wide range of the viewing window. The inner core and the puncture needle are mechanically decoupled. At the same time, the inner core and the puncture needle rotate relative to each other for support and avoidance. Meanwhile, the ultrasound probe fixed at the far end of the inner core scans synchronously. The ultrasound probe is based on the continuous spatial change of the two-dimensional imaging plane within the wide range of the viewing window, and performs three-dimensional reconstruction on the two-dimensional images acquired at different angles to obtain real-time or near-real-time three-dimensional images.

Images