A catheter ultrasound probe device and methods of using the same

Abstract

The application relates to the technical field of ultrasonic imaging of medical devices, in particular to a catheter ultrasonic probe device and a use method thereof. The device comprises a front-end ultrasonic probe array, a middle flexible pipeline and a tail-end control module. The ultrasonic probe array is detachably assembled on the outside 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 capable of energy regulation. A guide wire hole is arranged in the middle flexible pipeline and used for guiding the ultrasonic probe array to reach a target position. The tail-end control module is used for controlling the ultrasonic transducers and the imaging transducers, realizing time-sharing or joint use in a physiological parameter analysis process. The device can efficiently, safely and accurately perform interventional energy regulation.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical instrument ultrasonic imaging energy regulation, and in particular to a catheter ultrasonic probe device and a method of using the same. BACKGROUND

[0002] In the field of modern interventional energy regulation, effective diagnosis and treatment of various diseases have an urgent need for precise, safe and efficient diagnosis and treatment integration technology. Medical imaging technologies such as ultrasonic imaging, CT imaging and magnetic resonance imaging are important guides for interventional energy regulation, which can present the internal structure of the human body, assist in determining the location, size and shape of the lesion, and provide a basis for the planning of energy regulation scheme.

[0003] In the clinical energy regulation of cardiovascular diseases, the catheter ultrasonic device, as a kind of advanced medical instrument, is gradually showing its unique potential for energy regulation. Especially in the treatment of intravascular thrombus and plaque, the device introduces vortex acoustic field technology, uses the mechanical effect, thermal effect and physicochemical effect of ultrasonic waves, can efficiently and safely promote thrombus dissolution, while reducing drug side effects and vascular damage. In addition, the application of high-frequency ultrasonic thermal effect technology can generate high temperature at the plaque site through ultrasonic energy, achieve coagulative necrosis of the plaque, and promote the repair and regeneration of the vascular wall, significantly improving the accuracy and safety of energy regulation for cardiovascular diseases.

[0004] In summary, the existing technology faces many challenges in the process of diagnosis and treatment integration, and a new technology is urgently needed to not only utilize the unique mechanical effect, thermal effect and physicochemical effect of ultrasound, but also break through the limitations of traditional imaging technology in energy regulation monitoring, realize seamless connection and collaborative operation of precise imaging and effective energy regulation, and provide better, safer and more accurate diagnosis and treatment integration solutions for interventional energy regulation of various diseases, and promote the development of interventional energy regulation technology to a new stage. SUMMARY

[0005] The technical problem to be solved by the present application is to provide a catheter ultrasonic probe device and a method of using the same to solve the technical problem that traditional imaging technology has limitations in energy regulation monitoring and cannot realize seamless connection of precise imaging and effective energy regulation.

[0006] The purpose of the present application is achieved by the following technical solutions:

[0007] In a first aspect, the present application provides a catheter ultrasonic probe device, comprising: an ultrasonic probe array at the front end, a flexible pipeline in the middle and a control module at the end.

[0008] The ultrasonic probe array is detachably assembled outside the end of the flexible pipeline; the ultrasonic probe array comprises a plurality of ultrasonic transducers and / or a plurality of imaging transducers, the ultrasonic transducers are used for emitting energy, and the imaging transducers are used for imaging a target region;

[0009] The intermediate flexible pipeline is internally provided with a guide wire hole for guiding the ultrasonic probe array to reach a target position;

[0010] The end control module is used for controlling the ultrasonic transducers and the imaging transducers, so as to realize time-sharing or joint control of the ultrasonic transducers and the imaging transducers.

[0011] As a further improvement of the present application, the ultrasonic probe array comprises:

[0012] 1 to n independently operating tubular ultrasonic transducers; the tubular ultrasonic transducers are cut into independent units at a set angle along the axial direction; the tubular ultrasonic transducers are used for radiating energy to the periphery, so as to realize circumferential energy intervention;

[0013] The surface of the tubular ultrasonic transducer is used for coating an active substance, so as to realize circumferential local active substance delivery.

[0014] As a further improvement of the present application, the ultrasonic probe array comprises:

[0015] 1 to n cylindrical ultrasonic transducers, the cylindrical ultrasonic transducers emit energy forward to realize radial energy intervention; when the number of cylindrical ultrasonic transducers is 1, a vortex acoustic lens is assembled, and vortex acoustic field efficiency energy regulation is performed through motor transmission; when the number of cylindrical ultrasonic transducers is multiple, vortex acoustic field efficiency energy regulation is performed through stepwise circumferential arrangement or phase regulation.

[0016] The front end surface of the cylindrical ultrasonic transducer is coated with an active substance, so as to realize radial local active substance delivery energy regulation.

[0017] As a further improvement of the present application, the ultrasonic probe array comprises:

[0018] The ultrasonic probe array comprises a protrusion for matching connection with the intermediate flexible pipeline, 1 to n fan-shaped ultrasonic transducers are arranged on both sides of the protrusion, the fan-shaped ultrasonic transducers are arranged inside the protrusion and are used for acoustic field energy focusing; an imaging transducer is arranged at the middle position inside the protrusion, the number of the imaging transducers is 1 to n, and the imaging section sound beam of the imaging transducers penetrates the acoustic field energy focusing area.

[0019] An imaging transducer composed of n x m array elements and detachably assembled at the front end of the flexible pipe, the n x m array elements are arranged in a linear or cross shape, and the forward emission of the acoustic beam of the imaging transducer realizes radial imaging.

[0020] 1-n fan-shaped ultrasonic transducers assembled around the imaging transducer for forward emission of the acoustic field to realize radial anomaly feature recognition; when the fan-shaped ultrasonic transducers are multiple, the step-like circumferential arrangement or phase control is used to realize the synergistic control of vortex acoustic field.

[0021] As a further improvement of the application, the front end of the flexible pipe is provided with a hollow sandwich layer; the inner middle part includes a single hollow channel and two peripheral hollow channels, and the single hollow channel and the peripheral hollow channels are in communication with the hollow sandwich layer; the single hollow channel is used for transmitting wires, and the two peripheral hollow channels are respectively used for inflow or outflow of liquid or gas.

[0022] As a further improvement of the application, the ultrasonic transducer is superimposed with a matching layer and a piezoelectric ceramic element from inside to outside.

[0023] As a further improvement of the application, the ultrasonic transducer is used to realize thrombolysis and ablation, and the corresponding working parameters of thrombolysis and ablation respectively include:

[0024] When the thrombolysis function is used, the frequency range of the ultrasonic transducer is 20 kHz-5 MHz, and the power is 10-60 W;

[0025] When the ablation function is used, the frequency range of the ultrasonic transducer is 3 MHz-10 MHz, and the power is 3-15 W;

[0026] The working frequency of the imaging transducer is 5 MHz-15 MHz.

[0027] As a further improvement of the application, the end control module is used to synchronously control multiple ultrasonic transducers, control the phase of pulse emission waveform, amplify through a power amplifier, and realize the synergistic energy control of vortex acoustic field.

[0028] In a second aspect, the application provides a catheter ultrasonic probe device use method based on the above-mentioned catheter ultrasonic probe device, which comprises:

[0029] Assembling the detachable ultrasonic probe array to the outside of the flexible pipe end, the ultrasonic probe array includes a plurality of ultrasonic transducers and / or a plurality of imaging transducers; the ultrasonic transducer is used for emitting energy, and the imaging transducer is used for imaging in the target area;

[0030] Passing the guide wire through the guide wire hole of the intermediate flexible pipe, and guiding the ultrasonic probe array to the target area by the guide wire;

[0031] The corresponding working mode is selected through the terminal control module, and the ultrasonic probe array is controlled in time sharing or jointly; the working mode includes circumferential energy regulation, radial energy regulation, circumferential anomaly identification and radial anomaly identification;

[0032] After the control is completed, the ultrasonic probe array stops working, the terminal control module is closed, and the flexible pipeline and the ultrasonic probe array are exited through the guide wire.

[0033] The embodiment of the present application provides a catheter ultrasonic probe device, which realizes circumferential energy regulation and circumferential anomaly identification, radial energy regulation and radial energy identification energy regulation through a detachable ultrasonic probe array, meeting different needs. The present application also integrates ultrasonic imaging and energy regulation functions in the same device, avoiding the trouble of needing to replace equipment multiple times in the traditional diagnosis and treatment process, simplifying the diagnosis and treatment process and shortening the diagnosis and treatment time. The ultrasonic transducer is accurate under the guidance of imaging, avoiding damage to the surrounding healthy tissue and improving the safety and effectiveness of energy regulation. The pipeline made of flexible material can be flexibly advanced and controlled in a narrow and curved channel such as a blood vessel, reducing damage to the blood vessel wall and reducing the risk of complications. The guide wire hole is designed to pass through, ensuring that the probe array can accurately reach the target position and avoiding the risk of misoperation. The control module can realize 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.

[0034] Further, the tubular ultrasonic transducer can uniformly radiate energy to the surrounding, realizing 360° omnidirectional coverage energy regulation of the lesion area. At the same time, it avoids the problem of limited energy regulation range of traditional linear or fan-shaped transducers, ensuring that there is no dead angle energy regulation in the lesion area. The tubular transducer is cut into multiple independent units along the axial direction at a set angle, each unit can work independently, and specific transducers can be flexibly selected according to the specific position and shape of the lesion, realizing accurate directional energy regulation of the lesion area. The tubular design makes the ultrasonic energy more uniformly diffuse to the surrounding, reduces energy loss and improves energy transmission efficiency. At the same time, the transducer surface is coated with drugs, and the local release and penetration of drugs are promoted by ultrasonic energy. The combination of drugs and ultrasonic energy promotes drug penetration and absorption through ultrasonic imaging, and local drug delivery can reduce systemic exposure of drugs and reduce the risk of side effects. BRIEF DESCRIPTION OF DRAWINGS

[0035] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0036] Figure 1 The schematic diagram of the shape structure of the energy regulation of the catheter ultrasonic probe device in the application;

[0037] Figure 2 The schematic diagram of the structure of the transducer in the application;

[0038] Figure 3 The schematic diagram of the shape structure of the catheter ultrasonic circumferential abnormal feature recognition integrated device in the application;

[0039] Figure 4 The schematic diagram of the structure of the transducer in the application;

[0040] Figure 5 The schematic diagram of the shape structure of the catheter ultrasonic radial energy regulation (phased array vortex) device in the application;

[0041] Figure 6 The schematic diagram of the structure of the transducer in the application;

[0042] Figure 7 The schematic diagram of the shape structure of the catheter ultrasonic radial energy regulation (four array elements) device in the application;

[0043] Figure 8 The schematic diagram of the structure of the transducer in the application;

[0044] Figure 9 The schematic diagram of the shape structure of the catheter ultrasonic radial abnormal feature recognition integrated device in the application;

[0045] Figure 10 The schematic diagram of the structure of the transducer in the application;

[0046] In the figure, 1, flexible pipeline; 2, guide wire hole; 31, first ultrasonic transducer group; 311, first matching layer; 312, first piezoelectric ceramic element; 4, protruding part; 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, pipe body; 12, hollow sandwich layer; 13, single hollow channel; 14, peripheral hollow channel. DETAILED DESCRIPTION

[0047] In order to make the purpose and technical scheme of the present application clearer and more convenient to understand, the present application will be further described in detail below in combination with the drawings and examples. The specific examples described herein are only used to explain the present application and are not intended to limit the present application.

[0048] The technical scheme of the present application will be described clearly and completely below in combination with the drawings and specific examples. The described examples are only a part of the examples of the present application, but not all the examples.

[0049] Example 1

[0050] As Figures 1-10 , the present embodiment provides a catheter ultrasonic probe device. The device includes a front-end ultrasonic probe array, a middle flexible pipe 1 and a tail-end control module.

[0051] The front-end ultrasonic probe array is detachably assembled outside the tail end of the flexible pipe 1. The connection mode includes buckle connection, plug-in connection mode or magnetic connection + plug-in connection.

[0052] 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 used to realize circumferential energy regulation and circumferential anomaly identification, radial energy regulation and radial anomaly identification through different assembly modes.

[0053] When circumferential energy regulation is performed, as Figures 1-2 shown, the ultrasonic probe array includes 1 to n independently operating 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 the surrounding, realizing circumferential energy regulation.

[0054] In addition, the surface of the first ultrasonic transducer 31 is used to coat a drug, which is used for circumferential local drug delivery. The first ultrasonic transducer 31 has a first matching layer 311 and a first piezoelectric ceramic element 312 superimposed from inside to outside.

[0055] As Figures 5-8 shown, when radial energy regulation is performed, the ultrasonic probe array includes 1 to n cylindrical ultrasonic transducers (i.e. fourth ultrasonic transducers 32), the cylindrical ultrasonic transducers (fourth ultrasonic transducers 32) emit energy forward to realize radial energy regulation; when the number of cylindrical ultrasonic transducers is 1, a vortex acoustic lens 10 is assembled, and through motor transmission, vortex acoustic field efficiency energy regulation is realized; when the number of cylindrical ultrasonic transducers is multiple, through stepwise circumferential arrangement or phase regulation, a fifth ultrasonic transducer group 33 is obtained, realizing vortex acoustic field efficiency energy regulation.

[0056] The front end surface of the cylindrical ultrasonic transducer is coated with drugs to achieve radial local drug delivery.

[0057] The fourth ultrasonic transducer 32 is stacked with a third matching layer 321 and a third piezoelectric ceramic element 322 from the inside out. 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 out.

[0058] like Figures 3-4 As shown, when performing circumferential anomaly feature identification, the ultrasonic probe array includes: a protrusion 4 for mating with the intermediate flexible pipe. Two sides of the protrusion are provided with one to n sector-shaped ultrasonic transducers (i.e., a second ultrasonic transducer 5 and a third ultrasonic transducer 7). The sector-shaped ultrasonic transducers are located inside the protrusion and are used to focus the acoustic field energy. An imaging transducer (i.e., a first imaging transducer 6) is located in the middle of the protrusion. The imaging transducer's imaging section acoustic beam penetration energy regulates the acoustic field energy focus area. The ultrasonic transducer is stacked from the inside to the outside with a second matching layer 8 and a second piezoelectric ceramic element 9.

[0059] like Figures 9-10 As shown, when radial abnormality feature detection is performed, the ultrasonic probe array includes: an imaging transducer, which 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. The sound beam of the imaging transducer is emitted forward to achieve radial imaging;

[0060] One to n sector-shaped ultrasonic transducers (i.e., the sixth ultrasonic transducer group 34) are assembled around the imaging transducer, emitting a forward sound field to achieve radial energy control. When multiple sector-shaped ultrasonic transducers are present, vortex sound field enhancement and energy control are achieved through stepped circumferential arrangement or phase control. The sixth ultrasonic transducer group 34 is stacked from the inside out with a fifth matching layer 341, a fifth piezoelectric ceramic element 342, and a backing 343.

[0061] In addition, the ultrasonic transducer in this embodiment is stacked from the inside out with a matching layer and piezoelectric ceramic elements. The piezoelectric elements of the ultrasonic transducer meet the requirements of a high electromechanical coupling coefficient, a high voltage electric strain constant, a high quality factor, low dielectric loss, and low mechanical loss. The piezoelectric elements of the imaging ultrasonic transducer meet the requirements of a high electromechanical coupling coefficient, a piezoelectric strain constant, and a low quality factor. The front-end ultrasonic probe array is prepared by stacking and cutting the matching layers and piezoelectric elements from the outside in. Radial anomaly feature detection also includes a backing mounted inside the piezoelectric element.

[0062] Ultrasonic transducers are used to achieve thrombolysis and ablation. The corresponding working parameters of thrombolysis and ablation include:

[0063] The frequency range of the ultrasonic transducer is 20 kHz-5 MHz and the power is 10-60 W when the thrombolytic function is performed.

[0064] The frequency range of the ultrasonic transducer is 3 MHz-10 MHz and the power is 3-15 W when the ablation function is performed.

[0065] The working frequency of the imaging transducer is 5 MHz-15 MHz.

[0066] The intermediate flexible pipeline is provided with a guide wire hole 2 inside for guiding the ultrasonic probe array to reach the target position. The pipe diameter of the catheter is about 5-15 Fr to adapt to the thrombolytic, ablation, and drug delivery operations in blood vessels of different diameters.

[0067] For the radial abnormal feature detection process, the front end of the flexible pipeline in the embodiment is provided with a hollow sandwich 12; the inside intermediate part 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 in communication with the hollow sandwich 12; when the radial abnormal feature detection is performed, the single hollow channel 13 is used for transmitting the guide wire, and the two peripheral hollow channels 14 are respectively used for inflow or outflow of liquid or gas.

[0068] The terminal control module is used for controlling the ultrasonic transducer and the imaging transducer to realize the time-sharing or joint use in the abnormal feature detection process. The terminal control module is used for synchronously controlling multiple ultrasonic transducers, regulating the pulse emission waveform phase, amplifying through a power amplifier, and realizing the vortex sound field efficiency energy regulation. The catheter ultrasonic abnormal feature detection probe device meets the electrical safety requirements.

[0069] The embodiment adopts flexible materials and innovative catheter design, reduces the damage to the inner wall of the blood vessel, realizes more effective intravascular energy regulation such as thrombolysis and plaque ablation by accurately controlling the frequency and energy output of the ultrasonic wave, and makes the energy regulation coverage range reach 360° through the annular transducer and four-element array design, and comprehensively regulates the lesion area. In addition, the imaging probe and the energy regulation probe can be combined to realize real-time intravascular imaging and energy regulation, and greatly improve the accuracy and safety of energy regulation.

[0070] Embodiment 2

[0071] The whole includes the front end ultrasonic probe array, the intermediate flexible pipeline, and the terminal control module; the front end ultrasonic probe array can realize the circumferential energy regulation, the radial energy regulation, the circumferential abnormal feature detection, and the radial abnormal feature detection; the front end ultrasonic probe array can realize the nearby monitoring of the thrombolysis, the ablation, the drug delivery, and the energy regulation target area through the selection of the piezoelectric element, the working frequency of the imaging and energy regulation, and the energy regulation power; the front end ultrasonic probe array is assembled on the outside of the flexible catheter terminal, and the guide wire hole is reserved in the hollow of the intermediate catheter.

[0072] For a catheter ultrasonic probe device front end to achieve circumferential energy regulation probe array, as shown in Figure 1 The ultrasonic transducer is composed of 1 to n independently operable tubular ultrasonic transducers, which radiate energy to the periphery to achieve circumferential energy regulation; the front-end catheter and the ultrasonic transducer surface are coated with medicine to deliver medicine 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 at different angles to achieve directional energy regulation in different angle directions and can be independently controlled.

[0073] For a catheter ultrasonic probe device front end to achieve radial energy regulation probe array, as shown in Figure 5 , 7 The ultrasonic transducer is composed of 1 to n independently operable tubular ultrasonic transducers, which radiate energy to the periphery to achieve circumferential energy regulation; the front-end catheter and the ultrasonic transducer surface are coated with medicine to deliver medicine 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 at different angles to achieve directional energy regulation in different angle directions and can be independently controlled.

[0074] 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 and cost-effectiveness, and customization ability, and is very suitable for this application scenario.

[0075] For a catheter ultrasonic probe device to detect circumferential abnormal features, as shown in Figure 3 The front end of the catheter is provided with a protruding part, the probes are distributed inside the protruding part, the imaging ultrasonic transducer is in the middle, and the ultrasonic transducers are distributed on both sides; the ultrasonic transducers distributed on both sides are composed of 1 to m independently operable sector-shaped ultrasonic transducers to achieve acoustic field energy focusing; the imaging ultrasonic transducer is composed of 1 to n independently operable sector-shaped ultrasonic transducers, and the imaging section sound beam penetrates the energy regulation acoustic field energy focusing area.

[0076] For a catheter ultrasonic probe device to detect radial abnormal features, as shown in Figure 9 The imaging ultrasonic transducer is composed of n x m array elements and is assembled at the front end of the catheter, the array elements are linearly or crosswise arranged, and the sound beam is forwardly transmitted to realize radial imaging; 1 to n sector-shaped ultrasonic transducers are assembled around the imaging ultrasonic transducer, which can independently transmit sound field forwardly to realize radial energy regulation; when there are multiple ultrasonic transducers, the vortex acoustic field efficiency regulation is realized through stepwise circumferential arrangement or phase regulation.

[0077] The piezoelectric element of the ultrasonic transducer meets high electromechanical coupling coefficient, high piezoelectric strain constant, high quality factor, low dielectric loss and low mechanical loss; the piezoelectric element of the imaging ultrasonic transducer meets high electromechanical coupling coefficient, piezoelectric strain constant and low quality factor; the front-end ultrasonic probe array is prepared by matching layers, piezoelectric elements, and cutting and stacking from outside to inside. The radial anomaly feature detection also includes a backing assembled inside the piezoelectric element.

[0078] The piezoelectric material selected for the imaging probe, such as PZT-5, has a high electromechanical coupling coefficient that can efficiently convert electrical and mechanical energy, accurately transmit and receive ultrasonic signals during imaging, and improve the resolution and clarity of the images, allowing doctors to obtain clearer images of the internal structure of the human body and assist in diagnosing diseases; the piezoelectric material selected for the energy regulation probe, such as PZT-4, has low dielectric loss to reduce the ineffective consumption of electrical energy and low mechanical loss to ensure stable energy output, allowing ultrasonic energy to better act on the diseased area, improving energy utilization in energy regulation, enhancing the energy regulation effect, and reducing the impact on surrounding normal tissues, providing patients with a better energy regulation experience.

[0079] The ultrasonic transducer has a working frequency range of about 20 kHz to 5 MHz and a power range of about 10-60 W for thrombolytic function; the ultrasonic transducer has a working frequency range of about 3 MHz to 10 MHz and a power range of about 3-15 W for ablation function; the imaging ultrasonic transducer has a working frequency range of about 5 MHz-15 MHz.

[0080] The catheter has a diameter of about 5-15 Fr to accommodate thrombolysis, ablation, and drug administration operations in blood vessels of different diameters; the catheter has a through guide wire hole in the middle to allow the guide wire to pass through and guide the probe to the target position. The catheter front end of the catheter ultrasonic probe device for radial anomaly feature detection is provided with a hollow sandwich, which includes a single hollow channel and two peripheral hollow channels in the middle and is in communication with the hollow sandwich; the single hollow channel is used for transmitting a guide wire, and the two peripheral hollow channels are used for inflow or outflow of liquid or gas.

[0081] The catheter is made of flexible materials such as polytetrafluoroethylene, polyethylene, silicone rubber, nylon, and liquid crystal polymer to better meet the needs of tissue energy regulation surgery through the femoral artery into the tissue, and to facilitate the advancement and control in the blood vessel.

[0082] The control module synchronously controls the ultrasonic transducer and the imaging ultrasonic transducer of the front-end ultrasonic probe array to realize time-sharing or joint use of the anomaly feature detection function; multiple ultrasonic transducers are synchronously controlled to regulate the phase of the pulse emission waveform, which is amplified by a power amplifier to realize vortex sound field synergistic energy regulation; the catheter ultrasonic probe device meets the electrical safety requirements.

[0083] In the process of circumferential energy regulation, the catheter is inserted into the blood vessel through the guide wire hole, and the guide wire is inserted into the guide wire hole. The catheter is pushed to the target position. The ring-shaped transducer uniformly distributed on the outer periphery of the catheter starts to work, and the energy output parameters thereof are adjusted by the control module. When the working frequency is 20 kHz to 5 MHz, the internal structure of the thrombus is destroyed by the mechanical vibration effect and cavitation effect of ultrasound to achieve thrombolysis; when the working frequency is 3 MHz to 15 MHz, the plaque is ablated by the thermal effect and mechanical effect of ultrasonic energy. 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 convenient to push and control in the blood vessel, so as to realize 360° circumferential energy regulation.

[0084] In the process of radial energy regulation with phased array vortex, the flexible catheter is first inserted into the blood vessel, and the metal rod is inserted into the guide wire hole to connect the vortex acoustic lens and is pushed to the target position. The transducer is arranged on the outer surface of the end portion of the catheter, and the material performance thereof is good. The control module adjusts the parameters of the transducer, and works at a specific frequency to utilize the ultrasonic wave effect in thrombolysis, and adjusts the frequency to utilize the ultrasonic energy effect on the plaque in ablation. At the same time, the vortex acoustic lens 1 is rotated by the electrode rotating device to form a vortex acoustic field to change the direction of energy regulation, and radial energy regulation is completed. In the process of radial energy regulation of multiple array elements, the catheter is first inserted into the blood vessel, and the guide wire is inserted into the guide wire hole and is pushed to the target position. The multiple array element transducers of the front end are started, the control module is adjusted, the ultrasonic waves in the specific frequency range act on the thrombus and the plaque respectively, and the array element ladder is used to achieve better focusing, sound field distribution and depth control, and radial energy regulation is completed.

[0085] In the process of circumferential abnormal feature detection, the catheter is inserted into the blood vessel through the guide wire hole and cooperates with the guide wire to reach the protruding portion to the position, the circumferentially distributed imaging probe collects data to understand the condition of the blood vessel, and then the energy regulation probe is started by the control module according to the diagnosis result. The energy regulation probe acts by ultrasonic waves or ultrasonic energy, and the thrombus or plaque is processed accordingly. The control module can independently control each probe, and is used in time sharing or combination to realize comprehensive diagnosis and precise energy regulation of the blood vessel lesion, and the circumferential abnormal feature detection process is completed.

[0086] In the radial abnormal feature detection, the front end enters into the tissue or organ and adheres to the energy regulation area with the deepening of the tube body. The lead wire is transmitted through the middle single hollow channel to connect the front and rear ends, transmit the signal and energy, the peripheral two hollow channels make the liquid or gas flow in and out, and finally the hollow interlayer cools the liquid circulation to realize the precise imaging and energy regulation. In the tissue imaging and energy regulation, the lead wire enters into the tissue or organ and adheres to the abnormal feature detection area through the deepening of the middle single hollow channel; the peripheral two hollow channels are used for the inflow and outflow of the liquid or gas to effectively dissipate the heat generated by the transducer in the working process; the hollow interlayer is used for cooling the liquid to discharge the liquid.

[0087] Embodiment 3

[0088] The embodiment provides a catheter ultrasonic probe device use method. Based on the line of sight of the catheter ultrasonic probe device in the embodiment 1, the method steps of the method include:

[0089] Assembling a detachable ultrasonic probe array to the outside of the flexible pipe end, the ultrasonic probe array includes a plurality of ultrasonic transducers and / or a plurality of imaging transducers; the ultrasonic transducers are used for emitting energy, and the imaging transducers are used for imaging the target area;

[0090] Passing the guide wire through the guide wire hole of the middle flexible pipe, guiding the ultrasonic probe array to the target area by the guide wire;

[0091] Selecting the corresponding working mode through the end control module, and controlling the ultrasonic probe array in time sharing or jointly; the working mode includes the circumferential energy regulation, the radial energy regulation, the circumferential abnormal identification and the radial abnormal identification;

[0092] After the control is completed, stopping the ultrasonic probe array work, closing the end control module, and exiting the flexible pipe and the ultrasonic probe array through the guide wire.

Claims

1. A catheter ultrasound probe device, characterized in that: include: Ultrasonic probe array at the front, flexible pipe in the middle and control module at the end; 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 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 ultrasound probe array to the target position; The terminal control module is used to control the ultrasonic transducer and the imaging transducer to achieve time-sharing or joint control of the ultrasonic transducer and the imaging transducer; The ultrasonic probe array comprises: a plurality of independently operating 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 surface of the tubular ultrasonic transducers is used to coat active substances for circumferential localized active substance delivery; The ultrasonic probe array includes: a plurality of cylindrical ultrasonic transducers, which emit energy forward to achieve radial energy regulation and energy intervention; when the number of cylindrical ultrasonic transducers is one, a vortex acoustic lens is installed, and vortex sound field efficiency enhancement energy regulation is performed through motor transmission; when the number of cylindrical ultrasonic transducers is multiple, vortex sound field efficiency 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; The ultrasonic probe array includes: the ultrasonic probe array includes a protrusion for matching and connecting with the middle flexible pipe, and a plurality of 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 and are used 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 several. The imaging section sound beam penetration energy of the imaging transducer regulates the sound field energy focusing area.

2. The catheter ultrasound probe device according to claim 1, characterized in that: The ultrasound probe array comprises: An imaging transducer, which is composed of a plurality of array elements and is detachably mounted on the front end of the flexible pipe, wherein the array elements are arranged linearly or crosswise, and the acoustic beam of the imaging transducer is emitted forward to achieve radial imaging; Several fan-shaped ultrasonic transducers are assembled 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.

3. The catheter ultrasound probe device according to claim 2, characterized in that: The front end of the flexible pipe is provided with a hollow interlayer; the middle of the interior 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 used for the inflow or discharge of liquid or gas respectively.

4. The catheter ultrasound probe device according to any one of claims 1 to 3, characterized in that: The ultrasonic transducer is stacked with a matching layer and a piezoelectric ceramic element from the inside to the outside.

5. The catheter ultrasound probe device according to any one of claim 4, characterized in that: Ultrasonic transducers are used to achieve thrombolysis and ablation. The corresponding working parameters of thrombolysis and ablation include: In thrombolytic function, 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.

6. 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 the power amplifier to achieve vortex sound field efficiency energy regulation.

Images