Catheter ultrasonic probe device and use method thereof

Abstract

The invention relates to the technical field of ultrasonic imaging of medical instruments, in particular to a catheter ultrasonic probe device and a using method thereof.The device comprises an ultrasonic probe array at the front end, a middle flexible pipeline and a tail end control module, and the ultrasonic probe array is detachably assembled on the outer side of the tail end of the flexible pipeline; the ultrasonic probe array comprises a plurality of ultrasonic transducers and / or a plurality of imaging transducers for energy regulation and control; a guide wire hole penetrates through the interior of the middle flexible pipeline and is used for guiding the ultrasonic probe array to reach a target position; the tail end control module is used for controlling the ultrasonic transducer and the imaging transducer, time-sharing or combined use in the physiological parameter analysis process is achieved, and the device can efficiently, safely and accurately conduct intervention energy regulation and control.

Description

Technical Field

[0001] The present invention relates to the field of ultrasonic imaging energy regulation of medical devices, and in particular to a catheter ultrasonic probe device and a use method thereof. Background Art

[0002] In the field of modern interventional energy regulation, the effective diagnosis and treatment of various diseases urgently requires accurate, safe and efficient integrated diagnosis and treatment technology. Medical imaging technologies such as ultrasound imaging, CT imaging and magnetic resonance imaging are important guides for interventional energy regulation. They can present the internal structure of the human body, assist in determining key information such as the location, size and shape of lesions, and provide a basic basis for the planning of energy regulation programs.

[0003] In the clinical energy regulation of cardiovascular diseases, catheter ultrasound equipment, as a cutting-edge medical device, is gradually showing its unique energy regulation potential. Especially in the treatment of intravascular thrombi and plaques, the equipment can efficiently and safely promote thrombus dissolution by introducing vortex acoustic field technology and utilizing the mechanical effect, thermal effect and physical and chemical effect of ultrasound, while reducing drug side effects and vascular damage. In addition, the application of high-frequency ultrasonic thermal effect technology generates high temperature at the plaque site through ultrasonic energy, achieves coagulative necrosis of the plaque, and promotes the repair and regeneration of the vascular wall, significantly improving the accuracy and safety of energy regulation of cardiovascular diseases.

[0004] In summary, existing technologies face many challenges in the process of integrated diagnosis and treatment, and there is an urgent need to develop a new technology that can not only utilize the unique mechanical, thermal and physical and chemical effects of ultrasound, but also break through the limitations of traditional imaging technology in energy regulation and monitoring, and achieve seamless connection and coordinated operation of precise imaging and effective energy regulation, thereby providing better, safer and more accurate integrated diagnosis and treatment solutions for interventional energy regulation of various diseases, and promoting interventional energy regulation technology to a new stage of development. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a catheter ultrasound probe device and a method of using the same in view of the deficiencies in the above-mentioned prior art, so as to solve the technical problem that traditional imaging technology has limitations in energy regulation and monitoring and it is difficult to achieve seamless connection between precise imaging and effective energy regulation.

[0006] The objective of the present invention is achieved by the following technical solutions: In a first aspect, the present invention provides a catheter ultrasound probe device, comprising: an ultrasound probe array at the front end, a middle flexible pipe, and a terminal control module; The ultrasonic probe array is detachably mounted on the outside of the end of the flexible pipe; the ultrasonic probe array includes a plurality of ultrasonic transducers and / or a plurality of imaging transducers, the ultrasonic transducers are used to transmit energy, and the imaging transducers are used to form an image in the target area; A guide wire hole is formed inside the intermediate flexible pipe to guide the ultrasonic probe array to the target position; The terminal control module is used to control the ultrasonic transducer and the imaging transducer, and realize time-sharing or joint control of the ultrasonic transducer and the imaging transducer.

[0007] As a further improvement of the present invention, the ultrasound probe array comprises: 1 to n independently working tubular ultrasonic transducers; the tubular ultrasonic transducers are cut into independent units along the axial direction at a set angle; the tubular ultrasonic transducers are used to radiate energy in all directions to achieve circumferential energy intervention; The tubular ultrasonic transducer surface is used for coating active substances for circumferential local active substance delivery.

[0008] As a further improvement of the present invention, the ultrasound probe array comprises: 1 to n cylindrical ultrasonic transducers, the cylindrical ultrasonic transducers emit energy forward to achieve radial energy intervention; when the number of cylindrical ultrasonic transducers is 1, a vortex acoustic lens is installed, and the vortex acoustic field enhancement energy regulation is performed through motor transmission; when the number of cylindrical ultrasonic transducers is multiple, the vortex acoustic field enhancement energy regulation is performed through stepped circumferential arrangement or phase regulation; The front end surface of the cylindrical ultrasonic transducer is coated with an active substance, which is used to achieve radial local active substance delivery energy regulation.

[0009] As a further improvement of the present invention, the ultrasound probe array comprises: The ultrasonic probe array includes a protrusion for matching and connecting with the middle flexible pipe, 1 to n fan-shaped ultrasonic transducers are arranged on both sides of the protrusion, and the fan-shaped ultrasonic transducers are arranged on the inner side of the protrusion for focusing the sound field energy; an imaging transducer is arranged in the middle part of the inner side of the protrusion, the number of the imaging transducers is 1 to n, and the imaging section sound beam of the imaging transducer penetrates the sound field energy focusing area. As a further improvement of the present invention, the ultrasonic probe array includes: An imaging transducer, which is composed of n×m array elements and can be detachably assembled at the front end of the flexible pipe, wherein the n×m array elements are arranged in a linear or cross shape, and the acoustic beam of the imaging transducer is emitted forward to realize radial imaging; 1 to n fan-shaped ultrasonic transducers are mounted around the imaging transducer and are used to emit sound fields forward to realize radial abnormal feature recognition; when there are multiple fan-shaped ultrasonic transducers, vortex sound field enhancement control is realized through stepped circumferential arrangement or phase control.

[0010] As a further improvement of the present invention, a hollow interlayer is provided at the front end of the flexible pipe; the interior middle includes a single hollow channel and two peripheral hollow channels, and the single hollow channel and the peripheral hollow channels are both connected to the hollow interlayer; the single hollow channel is used to transmit the wire, and the two peripheral hollow channels are respectively used for the inflow or discharge of liquid or gas.

[0011] As a further improvement of the present invention, the ultrasonic transducer is stacked with a matching layer and a piezoelectric ceramic element from the inside to the outside.

[0012] As a further improvement of the present invention, the ultrasonic transducer is used to achieve thrombolysis and ablation, and the corresponding working parameters of thrombolysis and ablation include: When the thrombolytic function is used, the frequency range of the ultrasonic transducer is 20kHz-5MHz, and the power is 10-60W; In ablation function, the frequency range of the ultrasonic transducer is 3MHz-10MHz, and the power is 3-15W; The imaging transducer has an operating frequency of 5 MHz to 15 MHz.

[0013] As a further improvement of the present invention, the terminal control module is used to synchronously control multiple ultrasonic transducers, adjust the phase of the pulse emission waveform, and amplify it through a power amplifier to achieve vortex sound field efficiency energy regulation.

[0014] In a second aspect, the present invention provides a method for using a catheter ultrasound probe device, based on the above-mentioned catheter ultrasound probe device, comprising: Assembling a detachable ultrasound probe array to the outside of the end of the flexible pipe, the ultrasound probe array comprising a plurality of ultrasound transducers and / or a plurality of imaging transducers; the ultrasound transducers are used to transmit energy, and the imaging transducers are used to form an image in a target area; Insert a guide wire through the guide wire hole of the middle flexible pipe, and use the guide wire to guide the ultrasound probe array to the target area; The corresponding working mode is selected by the terminal control module to control the ultrasonic probe array in a time-sharing or joint manner; the working mode includes circumferential energy regulation, radial energy regulation, circumferential anomaly recognition and radial anomaly recognition; After the control is completed, the ultrasonic probe array is stopped, the terminal control module is closed, and the flexible pipe and the ultrasonic probe array are withdrawn through the guide wire.

[0015] The beneficial effects of the present invention are as follows: This embodiment provides a catheter ultrasound probe device, which realizes circumferential energy regulation and circumferential abnormality identification, radial energy regulation and radial energy identification energy regulation through a detachable ultrasound probe array to meet different needs. The present invention also integrates ultrasound imaging and energy regulation functions into the same device, avoiding the trouble of multiple equipment replacements in traditional diagnosis and treatment, simplifying the diagnosis and treatment process, and shortening the diagnosis and treatment time. The ultrasound transducer is accurate under the guidance of imaging, avoiding damage to surrounding healthy tissues, and improving the safety and effectiveness of energy regulation. The pipeline made of flexible materials can be flexibly advanced and manipulated in narrow and curved channels such as blood vessels, reducing damage to the blood vessel wall and reducing the risk of complications. The guidewire hole penetration design ensures that the probe array can accurately reach the target position and avoids the risk of misoperation. The control module can realize the time-sharing or joint use of diagnosis and treatment functions, avoiding mutual interference between imaging and energy regulation functions, and improving the safety and reliability of diagnosis and treatment.

[0016] Furthermore, the tubular ultrasonic transducer can radiate energy evenly in all directions, achieving 360° all-round coverage of energy control in the lesion area. At the same time, it avoids the problem of limited energy control range of traditional linear or fan-shaped transducers, ensuring energy control without dead angles in the lesion area. The tubular transducer is cut into multiple independent units at set angles along the axial direction. Each unit can work independently. A specific transducer can be flexibly selected according to the specific location and shape of the lesion to achieve precise directional energy control in the lesion area. The tubular design allows ultrasonic energy to spread more evenly in all directions, reducing energy loss and improving energy transfer efficiency. At the same time, the transducer surface is coated with drugs, and ultrasonic energy is used to promote local release and penetration of drugs. The drugs are combined with ultrasonic energy, and ultrasonic energy images are used to promote drug penetration and absorption. Local drug delivery can reduce systemic exposure of drugs and reduce the risk of side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 It is a schematic diagram of the external structure of the energy regulation of the catheter ultrasound probe device in the present invention; Figure 2 It is a schematic diagram of the structure of the transducer in the present invention; Figure 3 It is a schematic diagram of the appearance structure of the integrated device for identifying abnormal circumferential characteristics of catheter ultrasound in the present invention; Figure 4 It is a schematic diagram of the structure of the transducer in the present invention; Figure 5 It is a schematic diagram of the appearance structure of the catheter ultrasonic radial energy regulation (phased array vortex) device in the present invention; Figure 6 It is a schematic diagram of the structure of the transducer in the present invention; Figure 7 It is a schematic diagram of the appearance structure of the catheter ultrasound radial energy regulation (four array elements) device in the present invention; Figure 8 It is a schematic diagram of the structure of the transducer in the present invention; Fig. 9 It is a schematic diagram of the appearance structure of the integrated device for identifying radial abnormal features of catheter ultrasound in the present invention; Fig.10 It is a schematic diagram of the structure of the transducer in the present invention; In the figure, 1, flexible pipe; 2, guide wire hole; 31, first ultrasonic transducer group; 311, first matching layer; 312, first piezoelectric ceramic element; 4, protrusion; 5, second ultrasonic transducer; 6, first imaging transducer; 7, third ultrasonic transducer; 8, second matching layer; 9, second piezoelectric ceramic element; 32, fourth ultrasonic transducer; 10, vortex acoustic lens; 321, third matching layer; 322, third piezoelectric ceramic element; 33, fifth ultrasonic transducer group; 331, fourth matching layer; 332, fourth piezoelectric ceramic element; 34, sixth ultrasonic transducer group; 341, fifth matching layer; 342, fifth piezoelectric ceramic element; 343, backing; 11, tube body; 12, hollow interlayer; 13, single hollow channel; 14, outer hollow channel. DETAILED DESCRIPTION

[0019] In order to make the purpose and technical solution of the present invention clearer and easier to understand, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. The specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0020] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings and specific embodiments, wherein the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments.

[0021] Example 1 like Figure 1-Figure 10 This embodiment provides a catheter ultrasound probe device, which includes an ultrasound probe array at the front end, a middle flexible pipe 1 and a terminal control module.

[0022] The front ultrasonic probe array is detachably mounted on the outside of the end of the flexible pipe 1. The connection method includes a snap connection, a plug-in connection, or a magnetic connection + a plug-in connection.

[0023] The ultrasonic probe array includes a plurality of ultrasonic transducers and / or a plurality of imaging transducers. The ultrasonic transducers and the imaging transducers are assembled in different ways to realize circumferential energy regulation and circumferential abnormality recognition, radial energy regulation and radial abnormality recognition.

[0024] When circumferential energy regulation is performed, Figure 1-Figure 2 As shown, the ultrasonic probe array includes: 1 to n independently working tubular first ultrasonic transducers 31; the tubular first ultrasonic transducers 31 are cut into independent units along the axial direction at a set angle; the tubular first ultrasonic transducers 31 are used to radiate energy to all sides to achieve circumferential energy regulation; In addition, the surface of the first ultrasonic transducer 31 is used to coat drugs for circumferential local drug delivery. The first ultrasonic transducer 31 is stacked with a first matching layer 311 and a first piezoelectric ceramic element 312 from the inside to the outside.

[0025] like Figure 5-Figure 8 As shown, when radial energy regulation is performed, the ultrasonic probe array includes: 1 to n cylindrical ultrasonic transducers (i.e., the fourth ultrasonic transducer 32), and the cylindrical ultrasonic transducer (the fourth ultrasonic transducer 32) emits energy forward to achieve radial energy regulation; when the number of cylindrical ultrasonic transducers is 1, a vortex-shaped acoustic lens 10 is installed, and the vortex sound field efficiency enhancement energy regulation is achieved through motor transmission; when the number of cylindrical ultrasonic transducers is multiple, a fifth ultrasonic transducer group 33 is obtained through stepped circumferential arrangement or phase regulation to achieve vortex sound field efficiency enhancement energy regulation; The front end surface of the cylindrical ultrasonic transducer is coated with drugs to achieve radial local drug delivery.

[0026] The fourth ultrasonic transducer 32 is stacked with a third matching layer 321 and a third piezoelectric ceramic element 322 from the inside to the outside. The transducers in the fifth ultrasonic transducer group 33 are stacked with a third matching layer 331 and a third piezoelectric ceramic element 332 from the inside to the outside.

[0027] like Figure 3-Figure 4As shown, when the circumferential abnormal feature is identified, the ultrasonic probe array includes: the ultrasonic probe array includes a protrusion 4 for matching and connecting with the middle flexible pipe, 1 to n fan-shaped ultrasonic transducers (i.e., the second ultrasonic transducer 5 and the third ultrasonic transducer 7) are arranged on both sides of the protrusion, and the fan-shaped ultrasonic transducers are arranged on the inner side of the protrusion for focusing the energy of the sound field; an imaging transducer (i.e., the first imaging transducer 6) is arranged in the middle part of the inner side of the protrusion, the number of imaging transducers is 1 to n, and the imaging section sound beam of the imaging transducer penetrates the energy of the sound field to regulate the energy focusing area of ​​the sound field. The ultrasonic transducer is superimposed with a second matching layer 8 and a second piezoelectric ceramic element 9 from the inside to the outside.

[0028] like Figure 9-10 As shown, when radial abnormality feature detection is performed, the ultrasonic probe array includes: an imaging transducer, the imaging transducer is composed of n×m array elements and is detachably assembled at the front end of the flexible pipe, the n×m array elements are arranged in a linear or cross shape, and the sound beam of the imaging transducer is emitted forward to realize radial imaging; 1 to n sector-shaped ultrasonic transducers (i.e., the sixth ultrasonic transducer group 34), which are mounted around the imaging transducer and are used to emit the sound field forward to achieve radial energy regulation; when there are multiple sector-shaped ultrasonic transducers, the vortex sound field enhancement energy regulation is achieved through stepped circumferential arrangement or phase regulation. The sixth ultrasonic transducer group 34 is stacked with a fifth matching layer 341, a fifth piezoelectric ceramic element 342, and a backing 343 from the inside to the outside.

[0029] In addition, the ultrasonic transducer in this embodiment is stacked with matching layers and piezoelectric ceramic elements from the inside to the outside. The piezoelectric element of the ultrasonic transducer meets the requirements of high electromechanical coupling coefficient, high voltage electric strain constant, high quality factor, low dielectric loss and low mechanical loss; the piezoelectric element of the imaging ultrasonic transducer meets the requirements of high electromechanical coupling coefficient, piezoelectric strain constant and low quality factor; the front-end ultrasonic probe array is prepared by stacking and cutting the matching layer and piezoelectric element from the outside to the inside. The backing assembled inside the piezoelectric element is also included in the detection of radial abnormal features.

[0030] Ultrasonic transducers are used to achieve thrombolysis and ablation. The corresponding working parameters of thrombolysis and ablation include: When the thrombolytic function is used, the frequency range of the ultrasonic transducer is 20kHz-5MHz, and the power is 10-60W; In ablation function, the frequency range of the ultrasonic transducer is 3MHz-10MHz, and the power is 3-15W; The imaging transducer has an operating frequency of 5 MHz to 15 MHz.

[0031] A guide wire hole 2 is provided inside the middle flexible pipe for guiding the ultrasound probe array to the target position. The diameter of the catheter is about 5-15Fr to adapt to thrombolysis, ablation and drug administration operations in blood vessels of different diameters.

[0032] With respect to the radial abnormal feature detection process, the front end of the flexible pipe in this embodiment is provided with a hollow interlayer 12; the interior middle includes a single hollow channel 13 and two peripheral hollow channels 14, and the single hollow channel 13 and the peripheral hollow channels 14 are both connected to the hollow interlayer 12; when performing radial abnormal feature detection, the single hollow channel 13 is used to transmit the wire, and the two peripheral hollow channels 14 are used for the inflow or discharge of liquid or gas respectively.

[0033] The terminal control module is used to control the ultrasonic transducer and the imaging transducer to achieve time-sharing or joint use in the process of abnormal feature detection. The terminal control module is used to synchronously control multiple ultrasonic transducers, adjust the phase of the pulse emission waveform, and amplify the power amplifier to achieve vortex sound field enhancement energy regulation. The catheter ultrasonic abnormal feature detection probe device meets the electrical requirements for safety.

[0034] This embodiment uses flexible materials and innovative catheter design to reduce damage to the inner wall of the blood vessel. By precisely controlling the frequency and energy output of ultrasound, more effective intravascular energy regulation, such as thrombolysis and plaque ablation, is achieved. The annular transducer and four-element array design allow the energy regulation coverage to reach 360°, fully regulating the lesion area. In addition, the imaging probe is combined with the energy regulation probe to perform real-time intravascular imaging and energy regulation, greatly improving the accuracy and safety of energy regulation.

[0035] Example 2 The whole system includes a front-end ultrasonic probe array, a middle flexible pipe and a terminal control module; the front-end ultrasonic probe array can realize circumferential energy control, radial energy control, circumferential abnormal feature detection and radial abnormal feature detection; the front-end ultrasonic probe array can realize thrombolysis, ablation, drug delivery and local monitoring of energy control target areas through the selection of piezoelectric elements, imaging and energy control working frequencies and energy control power; the front-end ultrasonic probe array is installed on the outside of the end of the flexible catheter, and the guide wire hole is retained in the middle of the catheter.

[0036] For a probe array that realizes circumferential energy regulation at the front end of a catheter ultrasound probe device, such as Figure 1 As shown. The ultrasonic transducer is composed of 1 to n independently working tubular ultrasonic transducers, radiating energy in all directions to achieve circumferential energy regulation; drugs are coated on the front catheter and the surface of the ultrasonic transducer to deliver the drugs to the energy regulation target area to achieve circumferential local drug delivery; the ultrasonic transducer array can be cut into different units along the axial direction according to angles to achieve directional energy regulation in different angles and directions, and can be independently controlled.

[0037] For a probe array that realizes radial energy regulation at the front end of a catheter ultrasound probe device, such as Figure 5 , 7As shown. The ultrasonic transducer is composed of 1 to n cylindrical ultrasonic transducers arranged circumferentially, emitting energy forward to achieve radial energy regulation; when the number of ultrasonic transducers is 1, a vortex-shaped acoustic lens matched by acoustic parameters is installed at the front end, and the vortex acoustic field enhancement energy regulation is achieved through motor transmission; when the number of ultrasonic transducers is multiple, the vortex acoustic field enhancement energy regulation is achieved through stepped circumferential arrangement or phase regulation; drugs are applied on the front end catheter and the surface of the ultrasonic transducer to deliver the drugs to the energy regulation target area to achieve radial local drug delivery.

[0038] The vortex acoustic lens as a whole can be made of materials such as epoxy resin, which has excellent physical and chemical properties, good biocompatibility, processability, cost-effectiveness and customization capabilities, and is very suitable for this application scenario.

[0039] For a circumferential abnormal feature detection of a catheter ultrasound probe device, such as Figure 3 As shown. A protrusion is provided at the front end of the catheter, the probe is distributed inside the protrusion, the imaging ultrasonic transducer is in the center, and the ultrasonic transducers are distributed on both sides; the ultrasonic transducers distributed on both sides are composed of 1 to m independently working fan-shaped ultrasonic transducers to achieve sound field energy focusing; the imaging ultrasonic transducer is composed of 1 to n independently working fan-shaped ultrasonic transducers, and the imaging section sound beam penetration energy regulates the sound field energy focusing area.

[0040] For radial abnormality feature detection of a catheter ultrasound probe device, such as Fig. 9 As shown in the figure, the imaging ultrasonic transducer is composed of n×m array elements and is installed at the front end of the catheter. The array elements are arranged linearly or crosswise, and the sound beam is emitted forward to achieve radial imaging; 1 to n fan-shaped ultrasonic transducers are installed around the imaging ultrasonic transducer, and can independently emit the sound field forward to achieve radial energy regulation; when there are multiple ultrasonic transducers, the vortex sound field enhancement energy regulation is achieved through stepped circumferential arrangement or phase regulation.

[0041] The piezoelectric element of the ultrasonic transducer meets the requirements of high electromechanical coupling coefficient, high voltage electric strain constant, high quality factor, low dielectric loss and low mechanical loss; the piezoelectric element of the imaging ultrasonic transducer meets the requirements of high electromechanical coupling coefficient, piezoelectric strain constant and low quality factor; the front-end ultrasonic probe array is prepared by stacking and cutting the matching layer and piezoelectric element from outside to inside. The backing assembled inside the piezoelectric element is also included in the detection of radial abnormal features.

[0042] The piezoelectric materials selected for the imaging probe, such as PZT-5, have a high electromechanical coupling coefficient and can efficiently realize the conversion between electrical and mechanical energy. They can accurately transmit and receive ultrasonic signals during imaging, improve the resolution and clarity of imaging, and allow doctors to obtain clearer images of the internal structure of the human body to assist in the diagnosis of diseases. The piezoelectric materials selected for the energy regulation probe, such as PZT-4, have low dielectric loss to reduce the ineffective consumption of electrical energy, and low mechanical loss to ensure continuous and stable energy output, so that ultrasonic energy can better act on the lesion site, improve energy utilization in energy regulation, enhance the energy regulation effect, and reduce the impact on surrounding normal tissues, bringing patients a better energy regulation experience.

[0043] The operating frequency range of the ultrasonic transducer is about 20kHz to 5MHz, and the power range is about 10-60W, which has a thrombolytic function; the operating frequency range of the ultrasonic transducer is about 3MHz to 10MHz, and the power range is about 3-15W, which has an ablation function; the operating frequency range of the imaging ultrasonic transducer is about 5MHz-15MHz.

[0044] The diameter of the catheter is about 5-15Fr to accommodate thrombolysis, ablation, and drug administration in blood vessels of different diameters; a guidewire hole is provided in the middle of the catheter to allow the guidewire to pass through and guide the probe to the target location. The front end of the catheter for radial abnormality feature detection of the catheter ultrasound probe device is provided with a hollow interlayer, which includes a single hollow channel in the middle and two hollow channels on the periphery and are both connected to the hollow interlayer; the single hollow channel is used to transmit the guidewire, and the two hollow channels on the periphery are used for the inflow or discharge of liquid or gas.

[0045] The catheter is made of flexible materials as a whole, such as polytetrafluoroethylene, polyethylene, silicone rubber, nylon, liquid crystal polymer and the like, so as to better meet the needs of entering tissues through the femoral artery for tissue energy regulation surgery, and to facilitate advancement and manipulation within the blood vessel.

[0046] The ultrasonic transducer and imaging ultrasonic transducer of the front-end ultrasonic probe array are synchronously controlled through the control module to realize the time-sharing or joint use of the abnormal feature detection function; multiple ultrasonic transducers are synchronously controlled to adjust the phase of the pulse emission waveform, and the vortex sound field enhancement energy regulation is realized through amplification by the power amplifier; the catheter ultrasonic probe device meets the electrical requirements and is safe.

[0047] When performing circumferential energy regulation, the catheter is inserted through the blood vessel, the guidewire is inserted through the guidewire hole, and the catheter is pushed to the target position. The annular transducers evenly distributed on the periphery of the catheter start working, and their energy output parameters are adjusted through the control module. When the working frequency is between 20kHz and 5MHz, the mechanical vibration effect and cavitation effect generated by ultrasound are used to destroy the internal structure of the thrombus to achieve thrombolysis; when the working frequency is between 3MHz and 15MHz, the thermal effect and mechanical effect of ultrasonic energy are used to ablate the plaque. In this process, the drug coating on the surface of the catheter plays an auxiliary energy regulation role, and the catheter made of flexible material is easy to advance and manipulate in the blood vessel, realizing 360° circumferential energy regulation.

[0048] When performing radial energy regulation with phased array vortex, first insert the flexible catheter through the blood vessel, insert the metal rod through the guide wire hole to connect the vortex acoustic lens and push it to the target position. The transducers are arranged on the outer surface of the catheter end, and the material performance is good. The control module adjusts the transducer 4 parameters, works at a specific frequency to use the ultrasonic effect during thrombolysis, and adjusts the frequency to act on the plaque by the ultrasonic energy effect during ablation. At the same time, the electrode rotation device is used to drive the vortex acoustic lens 1 to rotate to form a vortex acoustic field to change the energy regulation direction and complete the radial energy regulation. When performing radial energy regulation of multiple array elements, first insert the catheter through the blood vessel, insert the guide wire through the guide wire hole and push it to the target position. The multiple array element transducers with a stepped front end are started, and the control module adjusts the parameters. Ultrasound acts on thrombus and plaque respectively in a specific frequency range, and better focusing, sound field distribution and depth control are achieved due to the stepped array elements, completing radial energy regulation.

[0049] When performing circumferential abnormal feature detection, the catheter enters the blood vessel through the guidewire hole in cooperation with the guidewire until the protrusion is in place, and the circumferentially distributed imaging probes collect data to understand the condition of the blood vessel. Then, based on the diagnosis results, the control module starts the energy regulation probe, which uses ultrasound or ultrasonic energy to perform corresponding treatment on the thrombus or plaque. The control module can independently control each probe, and use them in time-sharing or combined manner to achieve comprehensive diagnosis of vascular lesions and precise energy regulation, thereby completing the circumferential abnormal feature detection process.

[0050] When performing radial abnormal feature detection, the front end enters the tissue or organ as the tube goes deeper and sticks to the energy regulation area. The wire is transmitted through the single hollow channel in the middle to connect the front and rear ends, transmit signals and energy, and the two hollow channels on the outside allow liquid or gas to flow in and out. Finally, the hollow interlayer is used to cool the liquid circulation to achieve precise imaging and energy regulation. When performing tissue imaging and energy regulation, the wire is passed through the single hollow channel in the middle to enter the tissue or organ and stick to the abnormal feature detection area; the two hollow channels on the outside are used for the overall inflow and discharge of liquid or gas, effectively dissipating the heat generated by the transducer during operation; the hollow interlayer is used to cool the liquid so that it can be discharged.

[0051] Example 3 This embodiment provides a method for using a catheter ultrasound probe device. Based on the line of sight of the catheter ultrasound probe device in embodiment 1, the method steps of this method include: Assembling a detachable ultrasound probe array to the outside of the end of the flexible pipe, the ultrasound probe array comprising a plurality of ultrasound transducers and / or a plurality of imaging transducers; the ultrasound transducers are used to transmit energy, and the imaging transducers are used to form an image in a target area; Insert a guide wire through the guide wire hole of the middle flexible pipe, and use the guide wire to guide the ultrasound probe array to the target area; The corresponding working mode is selected by the terminal control module to control the ultrasonic probe array in a time-sharing or joint manner; the working mode includes circumferential energy regulation, radial energy regulation, circumferential anomaly recognition and radial anomaly recognition; After the control is completed, the ultrasonic probe array is stopped, the terminal control module is closed, and the flexible pipe and the ultrasonic probe array are withdrawn through the guide wire.

Claims

1. A catheter ultrasound probe device, characterized in that: include: The front end ultrasonic probe array, the middle flexible pipe and the end control module; The ultrasonic probe array is detachably mounted on the outside of the end of the flexible pipe; the ultrasonic probe array includes a plurality of ultrasonic transducers and / or a plurality of imaging transducers, the ultrasonic transducers are used to transmit energy, and the imaging transducers are used to form an image in the target area; A guide wire hole is formed inside the intermediate flexible pipe to guide the ultrasonic probe array to the target position; The terminal control module is used to control the ultrasonic transducer and the imaging transducer, and realize time-sharing or joint control of the ultrasonic transducer and the imaging transducer.

2. The catheter ultrasound probe device according to claim 1, characterized in that: Energy Control The ultrasonic probe array includes: 1 to n independently working tubular ultrasonic transducers; the tubular ultrasonic transducers are cut into independent units along the axial direction at a set angle; the tubular ultrasonic transducers are used to radiate energy in all directions to achieve circumferential energy intervention and energy regulation; The tubular ultrasonic transducer surface is used for coating active substances for circumferential local active substance delivery.

3. The catheter ultrasound probe device according to claim 1, characterized in that: Energy Control The ultrasonic probe array includes: 1 to n cylindrical ultrasonic transducers, the cylindrical ultrasonic transducers emit energy forward to realize radial energy regulation and energy intervention; when the number of cylindrical ultrasonic transducers is 1, a vortex acoustic lens is installed, and the vortex sound field enhancement energy regulation is performed through motor transmission; when the number of cylindrical ultrasonic transducers is multiple, the vortex sound field enhancement energy regulation is performed through stepped circumferential arrangement or phase regulation; The front end surface of the cylindrical ultrasonic transducer is coated with an active substance for achieving radial local active substance delivery.

4. The catheter ultrasound probe device according to claim 1, characterized in that: The ultrasound probe array comprises: The ultrasonic probe array includes a protrusion for matching and connecting with the middle flexible pipe, and 1 to n fan-shaped ultrasonic transducers are arranged on both sides of the protrusion. The fan-shaped ultrasonic transducers are arranged on the inner side of the protrusion for focusing the sound field energy; an imaging transducer is arranged in the middle part of the inner side of the protrusion, and the number of the imaging transducers is 1 to n. The imaging section sound beam penetration energy of the imaging transducer regulates the sound field energy focusing area.

5. The catheter ultrasound probe device according to claim 1, characterized in that: The ultrasound probe array comprises: An imaging transducer, which is composed of n×m array elements and can be detachably assembled at the front end of the flexible pipe, wherein the n×m array elements are arranged in a linear or cross shape, and the acoustic beam of the imaging transducer is emitted forward to realize radial imaging; 1 to n fan-shaped ultrasonic transducers are installed around the imaging transducer and are used to emit sound fields forward to realize radial energy regulation and abnormal feature recognition; when there are multiple fan-shaped ultrasonic transducers, vortex sound field enhancement regulation and energy regulation are realized through stepped circumferential arrangement or phase regulation.

6. The catheter ultrasound probe device according to claim 5, characterized in that: The front end of the flexible pipe is provided with a hollow interlayer; the interior middle includes a single hollow channel and two peripheral hollow channels, and the single hollow channel and the peripheral hollow channels are both connected to the hollow interlayer; the single hollow channel is used to transmit the wire, and the two peripheral hollow channels are respectively used for the inflow or discharge of liquid or gas.

7. The catheter ultrasound probe device according to any one of claims 1 to 5, characterized in that: The ultrasonic transducer is stacked with matching layers and piezoelectric ceramic elements from inside to outside.

8. The catheter ultrasound probe device according to any one of claim 7, characterized in that: Ultrasonic transducers are used to achieve thrombolysis and ablation. The corresponding working parameters of thrombolysis and ablation include: When the thrombolytic function is used, the frequency range of the ultrasonic transducer is 20kHz-5MHz, and the power is 10-60W; In ablation function, the frequency range of the ultrasonic transducer is 3MHz-10MHz, and the power is 3-15W; The imaging transducer has an operating frequency of 5 MHz to 15 MHz.

9. The catheter ultrasound probe device according to claim 1, characterized in that: The terminal control module is used to synchronously control multiple ultrasonic transducers, adjust the phase of the pulse emission waveform, and amplify it through a power amplifier to achieve vortex sound field efficiency energy regulation.

10. A method for using a catheter ultrasound probe device, based on the catheter ultrasound probe device according to any one of claims 1 to 9, characterized in that: include: Assembling a detachable ultrasound probe array to the outside of the end of the flexible pipe, the ultrasound probe array comprising a plurality of ultrasound transducers and / or a plurality of imaging transducers; the ultrasound transducers are used to transmit energy, and the imaging transducers are used to form an image in a target area; Insert a guide wire through the guide wire hole of the middle flexible pipe, and use the guide wire to guide the ultrasound probe array to the target energy regulation area; The corresponding working mode is selected by the terminal control module to control the energy regulation of the ultrasonic probe array in a time-sharing or joint manner; the working mode includes circumferential energy regulation, radial energy regulation, circumferential anomaly recognition and radial anomaly recognition; After the energy regulation is completed, the ultrasonic probe array is stopped, the terminal control module is turned off, and the flexible pipe and the ultrasonic probe array are withdrawn through the guide wire.

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