WO2023097784A1 - Dual-frequency endoscopic catheter and imaging device - Google Patents

Dual-frequency endoscopic catheter and imaging device Download PDF

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Publication number
WO2023097784A1
WO2023097784A1 PCT/CN2021/138045 CN2021138045W WO2023097784A1 WO 2023097784 A1 WO2023097784 A1 WO 2023097784A1 CN 2021138045 W CN2021138045 W CN 2021138045W WO 2023097784 A1 WO2023097784 A1 WO 2023097784A1
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Prior art keywords
dual
ultrasonic transducer
frequency
endoscopic catheter
catheter
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PCT/CN2021/138045
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French (fr)
Chinese (zh)
Inventor
马腾
张琪
高磊
孔瑞明
吴铮杰
陈焯权
黄继卿
李永川
郑海荣
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深圳先进技术研究院
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Publication of WO2023097784A1 publication Critical patent/WO2023097784A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0073Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by tomography, i.e. reconstruction of 3D images from 2D projections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0891Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • the invention relates to the technical field of medical device design, in particular to a dual-frequency endoscopic catheter and an imaging device.
  • the imaging device can be applied not only in the cardiovascular system, but also in the auxiliary diagnosis of the upper and lower digestive tracts.
  • CT Computed Tomography
  • MRI Magnetic Resonance Imaging
  • Intravascular Optical Coherence Tomography Tomography combines endoscopic and laparoscopic techniques on the basis of traditional OCT, which can provide higher-resolution tomographic imaging, thereby improving the accuracy of cardiovascular disease diagnosis; however, OCT optical imaging is due to the highlight of soft tissue Absorption and scattering properties, which reduce the imaging depth. Second, additional surgical risks are added due to the necessary blood flushing step.
  • IVUS Intravascular Ultrasound
  • the ultrasonic transducer frequency of the traditional IVUS imaging catheter is fixed at 20MHz-40MHz, which can only provide specific axial resolution, lateral resolution and imaging depth; A compromise has been made between the two aspects of depth, so it is impossible to distinguish fine structures such as the fibrous cap of the cardiovascular wall (the size is about 65um), which limits its ability to image cardiovascular structures and tiny plaques, so it is difficult to detect diseased tissues. Multi-level accurate diagnosis.
  • optical coherence tomography sacrifices imaging depth while providing high-resolution imaging, and has to introduce a flushing device; moreover, these studies all use multi-system coupling, which makes the device more complex and enables high-quality The cost of the image is greatly increased.
  • the present invention provides a dual-frequency endoscopic catheter and imaging device, the technical solution is as follows:
  • a dual-frequency endoscopic catheter, the dual-frequency endoscopic catheter includes:
  • the driving component located on one side of the housing, the driving component is used to drive the housing to rotate;
  • the sidewall of the housing has an open area
  • a first ultrasonic transducer and a second ultrasonic transducer located in the opening area and arranged in sequence along the first direction;
  • the first direction is the same as the length extension direction of the housing.
  • the frequency of the first ultrasonic transducer is less than or equal to 40 MHz;
  • the frequency of the second ultrasonic transducer is greater than 40MHz.
  • the dual-frequency endoscopic catheter further includes:
  • a base located in the opening area, and the base is fixedly connected to the housing;
  • the first ultrasonic transducer and the second ultrasonic transducer are fixed on the base.
  • the side of the casing facing away from the driving part is in the shape of a bullet.
  • the driving component is a torque coil
  • the number of coil layers of the torque coil is at least two layers.
  • the dual-frequency endoscopic catheter further includes:
  • a second coaxial cable connected to the second ultrasonic transducer.
  • the structure of the first ultrasonic transducer and the second ultrasonic transducer is the same, including:
  • the second direction is perpendicular to the backing layer, and is directed from the backing layer to the first electrode layer.
  • the structure of the first ultrasonic transducer and the second ultrasonic transducer are the same, further comprising:
  • a conductive layer located on a side of the second electrode layer away from the piezoelectric layer
  • the conductive layer is adjacent to the second electrode layer.
  • grooves are formed on the side of the backing layer away from the first electrode layer.
  • An imaging device comprising: a rotation retraction control module, a data acquisition module, an ultrasonic catheter component, and a host computer;
  • the rotation retraction control module is communicatively connected with the data acquisition module
  • the data acquisition module is communicatively connected with the host computer
  • the ultrasonic catheter components include: a proximal drive slot, a catheter sheath, and the dual-frequency endoscopic catheter described in any one of the above;
  • One end of the proximal drive slot is connected to the rotation retraction control module, and the other end is connected to one end of the catheter sheath;
  • the dual frequency endoscopic catheter is located within the introducer sheath.
  • a dual-frequency endoscopic catheter provided by the present invention includes: a casing; a driving part located on one side of the casing, and the driving part is used to drive the casing to rotate; the side wall of the casing has an opening area; The first ultrasonic transducer and the second ultrasonic transducer are arranged in sequence along the first direction in the opening area; wherein the first direction is the same as the length extension direction of the housing.
  • the dual-frequency endoscopic catheter places two ultrasonic transducers in the catheter in a set arrangement, and the two transducers can transmit and receive ultrasonic pulses at the same time or with a delay, or can transmit and receive ultrasonic pulses independently , to provide high-quality ultrasonic dual-frequency fusion images by organically combining the array elements with two resolution capabilities.
  • the matching layer of the dual-frequency ultrasonic transducer is made by high-precision coating, which effectively improves the output bandwidth and response amplitude of the transducer.
  • FIG. 1 is a schematic structural diagram of an imaging device provided by an embodiment of the present invention.
  • Fig. 2 is a schematic structural diagram of an ultrasonic catheter component provided by an embodiment of the present invention.
  • Fig. 3 is a schematic structural diagram of a guide wire cavity provided by an embodiment of the present invention, a guide wire is arranged in the guide wire cavity;
  • Fig. 4 is a schematic structural diagram of a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
  • FIG. 5 is a schematic structural diagram of an ultrasonic transducer provided by an embodiment of the present invention.
  • Fig. 6 is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in Fig. 5 provided by an embodiment of the present invention
  • FIG. 7 is a schematic structural diagram of another ultrasonic transducer provided by an embodiment of the present invention.
  • Fig. 8 is a schematic diagram of the wiring corresponding to the structure of the ultrasonic transducer shown in Fig. 7 provided by an embodiment of the present invention.
  • Fig. 9 is a schematic flowchart of a method for manufacturing a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
  • the inventor found that, compared with the traditional single-array ultrasonic endoscopic catheter, the dual-frequency ultrasonic endoscopic catheter has two ultrasonic transducers with different frequencies.
  • the design and assembly process of the transducer has always been a major bottleneck restricting the development of endoscopic ultrasound imaging technology.
  • the matching layer of the ultrasonic transducer mostly adopts traditional single-layer or double-layer matching, and the acoustic impedance matching cannot be well guaranteed, so that the output bandwidth and amplitude response of the ultrasonic transducer are not high enough.
  • the frequency of the ultrasonic endoscopic catheter with a single transducer is fixed and single, the imaging resolution of the high-frequency ultrasonic endoscopic catheter is high but the imaging depth is very shallow, and the imaging depth of the low-frequency ultrasonic endoscopic catheter is deep but the resolution is greatly reduced. It restricts the development of ultrasound images to high resolution and high imaging depth.
  • two ultrasonic transducers are placed side by side in the catheter on the same side, and the two transducers can transmit and receive ultrasonic pulses at the same time or with a delay, and can also transmit and receive ultrasonic pulses independently.
  • Array elements with two resolving powers are organically combined to provide high-quality ultrasound images.
  • this application uses the artificial matching layer structure of three or more layers designed by relevant theories and simulations, and uses high-precision coating to make the matching layer of the dual-frequency ultrasonic transducer, effectively improving the output bandwidth of the transducer and response magnitude.
  • the technical solution provided by this application uses ultrasonic dual-frequency array elements for ultrasonic endoscopic elastography, which can realize the combination of ultrasonic imaging and ultrasonic functional imaging, and provide a more reliable basis for clinical diagnosis.
  • FIG. 1 is a schematic structural diagram of an imaging device provided by an embodiment of the present invention.
  • the imaging device includes: a rotation retraction control module 11 , a data acquisition module 12 , an ultrasound catheter component 13 and a host computer 14 .
  • the rotation retraction control module 11 is connected with the data acquisition module 12 in communication.
  • the data acquisition module 12 is connected with the host computer 14 in communication.
  • the rotation retraction control module 11 mainly includes: a motor, and a control module for controlling the working state of the motor.
  • the motor at least includes a rotating motor and a retracting motor.
  • FIG. 2 is a schematic structural diagram of an ultrasonic catheter component provided by an embodiment of the present invention.
  • the ultrasonic catheter components include: a proximal drive slot 131, a catheter sheath 132, and a dual-frequency endoscopic catheter 133 described in the following embodiments of this application.
  • One end of the proximal drive slot 131 is connected to the rotation retraction control module 11 , and the other end is connected to one end of the catheter sheath 132 .
  • the dual frequency endoscopic catheter 133 is located within the introducer sheath 132 .
  • the ultrasound catheter component 13 further includes: a retraction fixing block 134 located on the catheter sheath 132 , and a guide wire lumen 135 away from the proximal driving groove 131 .
  • FIG. 3 is a schematic structural diagram of a guidewire lumen provided by an embodiment of the present invention.
  • a guidewire is pre-threaded into the guidewire lumen 135 during surgery.
  • the proximal drive slot 131 is fixedly connected to the rotating motor in the rotation retraction control module 11 , and then connected to the retraction component in the rotation retraction control module 11 , and the retraction fixing block 134 is stationary during retraction.
  • a retractable distance greater than 150mm is taken as an example for illustration.
  • the proximal drive groove 131 is also provided with an injection cavity 136 , which provides a coupling environment for the ultrasonic transducer in the dual-frequency endoscopic catheter 133 and evacuates the air in the catheter sheath by injecting physiological saline.
  • both the introducer sheath 132 and the guide wire lumen 135 are made of biocompatible materials.
  • the catheter sheath 132 is divided into a part close to the proximal driving groove 131 and a part close to the guide wire lumen 135; wherein the catheter sheath 132 near the proximal driving groove 131 can be hard, non-transparent, and of high acoustic impedance
  • the catheter sheath 132, the catheter sheath 132 near the guide wire lumen 135 can be a soft, transparent, low acoustic impedance catheter sheath 132 as an imaging window.
  • the length of the opaque portion of the catheter sheath 132 is greater than 1 m, and the length of the imaging window is greater than 150 mm.
  • the length of the imaging window matches the maximum distance of the retraction distance.
  • the length of the imaging window is also set to 300mm.
  • a scale line can be set on the catheter sheath 132 between the retraction fixing block 134 and the proximal driving groove 131 to measure the retraction distance, and at the same time, a scale line can be set on the rotation retraction module.
  • the digital display board with a retraction distance corrects the non-uniform distortion caused by the movement of the catheter through a rigid correction algorithm to provide more accurate ultrasonic endoscopic images.
  • FIG. 4 is a schematic structural diagram of a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
  • the dual-frequency endoscopic catheter includes:
  • the driving part 16 located on one side of the casing 15 is used to drive the casing 15 to rotate.
  • the side walls of the housing 15 have open areas.
  • the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are located in the opening area and arranged in sequence along the first direction.
  • the first ultrasonic transducer 17 and the second ultrasonic transducer 18 can be placed side by side on the same side (that is, arranged longitudinally), or placed in parallel on the same side (that is, arranged horizontally), or placed on different sides Placed side by side (that is, vertically dislocated back-to-back arrangement), or other arrangements such as back-to-back placement on different sides.
  • the first direction is the same as the extending direction of the length of the housing 15 .
  • the housing 15 is used to carry the first ultrasonic transducer 17 and the second ultrasonic transducer 18 and protect the first ultrasonic transducer 17 and the second ultrasonic transducer 18 .
  • the side of the casing 15 facing away from the driving part 16 is in the shape of a bullet, and the length of the casing is extremely short.
  • the design of the short bullet shape can significantly reduce the non-uniform distortion of the catheter during bending and retraction.
  • the material of the housing 15 includes but not limited to biocompatible metal materials or non-metal materials, which need to have high strength to make it durable and increase its service life.
  • the dual-frequency endoscopic catheter also includes:
  • the base 19 is located in the opening area, and the base 19 is fixedly connected with the shell 15 .
  • the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are fixed on the base 19 .
  • the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are fixed inside the housing 15 through a base 19 .
  • the first ultrasonic transducer 17 and the second ultrasonic transducer 18 include but are not limited to being fixed on the base 19 with biocompatible glue, and the biocompatible glue can also play the role of isolation and insulation between the two .
  • the design of the base 19 can greatly improve the coaxiality and coplanarity of the first ultrasonic transducer 17 and the second ultrasonic transducer 18 .
  • the material of the base 19 includes but not limited to biocompatible non-metallic materials (insulating materials).
  • the frequency of the first ultrasonic transducer 17 is less than or equal to 40 MHz; the frequency of the second ultrasonic transducer 18 is greater than 40 MHz.
  • two ultrasonic transducers with different frequencies are taken as an example for illustration, wherein the first ultrasonic transducer 17 is a low-frequency ultrasonic transducer, and the second ultrasonic transducer 18 is a high-frequency ultrasonic transducer. frequency ultrasonic transducer.
  • the driving component 16 is a torque coil.
  • the number of coil layers of the torque coil is at least two layers, preferably three layers or more.
  • the casing 15 and the torque coil 16 include but are not limited to be connected and fixed by means of biocompatible glue, conductive silver glue or laser welding, and the torque coil is used to transmit the torque generated by the rotating motor.
  • the torque coil has at least three layers of coils to achieve rotation in two directions, clockwise or counterclockwise, and has excellent bending performance, anti-shaking performance and safety performance.
  • the dual-frequency endoscopic catheter is placed in the catheter sheath, and the area where the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are located corresponds to the imaging window of the catheter sheath.
  • the dual-frequency endoscopic catheter also includes:
  • a second coaxial cable 21 connected to the second ultrasonic transducer 18 .
  • first coaxial cable 20 and the second coaxial cable 21 are respectively connected to components such as the first ultrasonic transducer 17 and the second ultrasonic transducer 18 through the hollow area of the torque coil.
  • the introducer sheath, the guidewire lumen and the guidewire remain stationary, and the dual-frequency endoscopic catheter rotates and/or retracts.
  • FIG. 5 is a schematic structural diagram of an ultrasonic transducer provided in an embodiment of the present invention.
  • the first ultrasonic transducer 17 has the same structure as the second ultrasonic transducer 18, including:
  • the first electrode layer 23 , the piezoelectric layer 24 , the second electrode layer 25 and at least three layers of acoustic artificial matching laminates 26 are sequentially stacked on one side of the backing layer 22 .
  • the second direction is perpendicular to the backing layer 22 and is directed from the backing layer 22 to the first electrode layer 23 .
  • one or more of piezoelectric single crystal materials or piezoelectric single crystal composite materials (such as PMN-PT single crystal material) with superior piezoelectric or dielectric properties are used to implement the first ultrasonic transducer 17 and the development of a second ultrasound transducer 18 .
  • the backing layer 22 of the first ultrasonic transducer 17 and the second ultrasonic transducer 18 is prepared by using a material with high sound absorption performance (such as E-Solder 3022 or tungsten steel), so as to further reduce the
  • the array element thickness of the transducer 17 and the second ultrasonic transducer 18 makes the outer diameter of the dual-frequency endoscopic catheter about 0.2mm-10mm, which is more convenient for endoscopic imaging in narrow and deep cardiovascular structures.
  • the material of the first electrode layer 23 includes but not limited to Cr/Au material. (The electrode layer is first plated with nickel and chromium, and then gold-plated to ensure that the electrode is more firm).
  • the material of the second electrode layer 25 includes but not limited to Cr/Au material.
  • At least three successively stacked acoustic artificial matching layers 26 include a first acoustic artificial matching layer A1 and a second acoustic artificial matching layer A2 which are sequentially stacked in the second direction; through the first acoustic artificial matching The layer A1 and the second acoustic artificial matching layer A2 are sequentially stacked in the second direction to form at least three sequentially stacked acoustic artificial matching laminates 26 .
  • the material of the first artificial acoustic matching layer A1 may be a polymer material, such as parylene or the like.
  • the material of the second acoustic artificial matching layer A2 may be a polymer material or a metal material, such as gold and other metal materials.
  • the piezoelectric layer 24 may be piezoelectric ceramics, piezoelectric ceramic composite material, pressure-point single crystal material or piezoelectric single crystal composite material.
  • a groove 27 is formed on a side of the backing layer 22 away from the first electrode layer 23 .
  • FIG. 6 is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in FIG. 5 provided by an embodiment of the present invention.
  • the coaxial cable is connected with the second electrode layer.
  • FIG. 7 is a schematic structural diagram of another ultrasonic transducer provided in an embodiment of the present invention.
  • the first ultrasonic transducer 17 has the same structure as the second ultrasonic transducer 18, and also includes:
  • a conductive layer 28 located on the side of the second electrode layer 25 away from the piezoelectric layer 24;
  • the conductive layer 28 is adjacent to the second electrode layer 25 .
  • a conductive layer 28 may also be formed on the side of the second electrode layer 25 away from the piezoelectric layer 24 .
  • the material of the conductive layer 28 includes, but is not limited to, metal materials such as gold.
  • FIG. 8 is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in FIG. 7 provided by an embodiment of the present invention.
  • the conductive layer 28 is connected to the metal shell, and the metal shell is connected to the shielding end of the coaxial cable.
  • the acoustic artificial matching laminate 26 is only described by taking the number of three film layers as an example.
  • the first ultrasonic transducer and the second ultrasonic transducer are manufactured by combining theory and simulation with three or more layers of acoustic artificial matching laminates to achieve higher resolution and higher resolution.
  • Integrated integration of dual-frequency multi-scale imaging catheter with high signal-to-noise ratio and higher sensitivity; the positive and negative poles of the first ultrasonic transducer and the second ultrasonic transducer are realized through the two connection methods shown in Figure 6 and Figure 8 Connection.
  • FIG. 9 is a schematic flowchart of a method for manufacturing a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
  • S106 Arranging multiple layers of acoustic artificial matching layer material on the forward acoustic radiation surface of the array element.
  • the two different array elements are respectively plated with artificial acoustic structures and then assembled into the shell to obtain the best acoustic matching. (for Figure 6)
  • each embodiment in this specification is described in a progressive manner, and each embodiment focuses on the differences from other embodiments.
  • the description is relatively simple, and for relevant details, please refer to the description of the method part.

Abstract

A dual-frequency endoscopic catheter (133) and an imaging device. Two ultrasonic transducers (17, 18) are placed in a catheter in a set arrangement manner, and the two ultrasonic transducers (17, 18) can transmit and receive ultrasonic pulses simultaneously or in a delayed mode, and can independently transmit and receive the ultrasonic pulses. Array elements with two resolution capabilities are organically combined to provide a high-quality ultrasonic dual-frequency fusion image. A matching layer of the dual-frequency ultrasonic transducers (17, 18) is manufactured in a high-precision coating manner by using an artificial matching layer structure (26) with three or more layers of a correlation theory and simulation design, and the output bandwidth and the response amplitude of the ultrasonic transducers (17, 18) are effectively improved.

Description

一种双频内窥导管及成像装置A dual-frequency endoscopic catheter and imaging device 技术领域technical field
本发明涉及医学器件设计技术领域,更具体地说,涉及一种双频内窥导管及成像装置。该种成像装置既可以应用在心血管,也可以应用在上下消化道内的辅助诊断。The invention relates to the technical field of medical device design, in particular to a dual-frequency endoscopic catheter and an imaging device. The imaging device can be applied not only in the cardiovascular system, but also in the auxiliary diagnosis of the upper and lower digestive tracts.
背景技术Background technique
目前临床上常用的心血管诊断技术主要包括:电子计算机断层扫描(Computed Tomography,简称CT)以及磁共振成像(Magnetic Resonance Imaging,简称MRI),但是对于冠状动脉疾病的评估和经皮冠状动脉介入治疗的引导,需要更为精准的成像装置。At present, the commonly used clinical cardiovascular diagnostic techniques mainly include: Computed Tomography (CT for short) and Magnetic Resonance Imaging (MRI for short), but for the evaluation of coronary artery disease and percutaneous coronary intervention Guidance requires a more precise imaging device.
血管内光学相干层析成像(Intravascular Optical Coherence Tomography,简称IVOCT)在传统OCT的基础上结合了内窥镜和腹腔镜技术,能够提供较高分辨率的断层成像,从而提高心血管疾病诊断的准确性;但是,OCT光学成像由于软组织的高光吸收和散射特性,会降低成像深度。其次,由于必要的血液冲洗步骤,会增加额外的手术风险。Intravascular Optical Coherence Tomography Tomography (IVOCT for short) combines endoscopic and laparoscopic techniques on the basis of traditional OCT, which can provide higher-resolution tomographic imaging, thereby improving the accuracy of cardiovascular disease diagnosis; however, OCT optical imaging is due to the highlight of soft tissue Absorption and scattering properties, which reduce the imaging depth. Second, additional surgical risks are added due to the necessary blood flushing step.
血管内超声(Intravascular Ultrasound,简称IVUS)已广泛应用于基于动脉粥样硬化和冠脉支架的心血管疾病成像。Intravascular Ultrasound (IVUS) has been widely used in imaging cardiovascular diseases based on atherosclerosis and coronary stents.
然而,传统的IVUS成像导管的超声换能器频率固定,为20MHz-40MHz,也就只能提供特定的轴向分辨率、横向分辨率以及成像深度;由于单频IVUS导管在成像分辨率和成像深度两个方面做了折中考虑,因此无法分辨例如心血管壁纤维帽(尺寸在65um左右)等细微结构,限制了其对于心血管结构和微小斑块的成像能力,因此难以对病变组织进行多层次的精准诊断。However, the ultrasonic transducer frequency of the traditional IVUS imaging catheter is fixed at 20MHz-40MHz, which can only provide specific axial resolution, lateral resolution and imaging depth; A compromise has been made between the two aspects of depth, so it is impossible to distinguish fine structures such as the fibrous cap of the cardiovascular wall (the size is about 65um), which limits its ability to image cardiovascular structures and tiny plaques, so it is difficult to detect diseased tissues. Multi-level accurate diagnosis.
近年来,美国南加州大学研发了用于心血管内窥成像的多模态导管,在光学相干层析成像用于高分辨率成像的同时,超声换能器用于大深度成像。In recent years, the University of Southern California has developed a multimodal catheter for cardiovascular endoscopic imaging. While optical coherence tomography is used for high-resolution imaging, ultrasound transducers are used for large-depth imaging.
技术问题technical problem
但是,光学相干层析成像在提供分辨率成像的同时也牺牲了成像深度,还不得不引入冲洗装置;并且,这些研究均采用多系统的耦合的方式,使其装置更为复杂,使获得优质图像的代价大为增加。However, optical coherence tomography sacrifices imaging depth while providing high-resolution imaging, and has to introduce a flushing device; moreover, these studies all use multi-system coupling, which makes the device more complex and enables high-quality The cost of the image is greatly increased.
技术解决方案technical solution
有鉴于此,为解决上述问题,本发明提供一种双频内窥导管及成像装置,技术方案如下:In view of this, in order to solve the above problems, the present invention provides a dual-frequency endoscopic catheter and imaging device, the technical solution is as follows:
一种双频内窥导管,所述双频内窥导管包括:A dual-frequency endoscopic catheter, the dual-frequency endoscopic catheter includes:
外壳;shell;
位于所述外壳一侧的驱动部件,所述驱动部件用于带动所述外壳进行旋转;a driving component located on one side of the housing, the driving component is used to drive the housing to rotate;
所述外壳的侧壁具有开口区域;The sidewall of the housing has an open area;
位于所述开口区域内且延第一方向依次排列的第一超声换能器和第二超声换能器;a first ultrasonic transducer and a second ultrasonic transducer located in the opening area and arranged in sequence along the first direction;
其中,所述第一方向与所述外壳的长度延伸方向相同。Wherein, the first direction is the same as the length extension direction of the housing.
优选的,在上述双频内窥导管中,所述第一超声换能器的频率为小于或等于40MHz;Preferably, in the aforementioned dual-frequency endoscopic catheter, the frequency of the first ultrasonic transducer is less than or equal to 40 MHz;
所述第二超声换能器的频率为大于40MHz。The frequency of the second ultrasonic transducer is greater than 40MHz.
优选的,在上述双频内窥导管中,所述双频内窥导管还包括:Preferably, in the above-mentioned dual-frequency endoscopic catheter, the dual-frequency endoscopic catheter further includes:
位于所述开口区域内的底座,且所述底座与所述外壳固定连接;a base located in the opening area, and the base is fixedly connected to the housing;
所述第一超声换能器和所述第二超声换能器固定在所述底座上。The first ultrasonic transducer and the second ultrasonic transducer are fixed on the base.
优选的,在上述双频内窥导管中,所述外壳背离所述驱动部件的一侧为子弹头形状。Preferably, in the above-mentioned dual-frequency endoscopic catheter, the side of the casing facing away from the driving part is in the shape of a bullet.
优选的,在上述双频内窥导管中,所述驱动部件为力矩线圈;Preferably, in the above-mentioned dual-frequency endoscopic catheter, the driving component is a torque coil;
所述力矩线圈的线圈层数为至少两层。The number of coil layers of the torque coil is at least two layers.
优选的,在上述双频内窥导管中,所述双频内窥导管还包括:Preferably, in the above-mentioned dual-frequency endoscopic catheter, the dual-frequency endoscopic catheter further includes:
与所述第一超声换能器连接的第一同轴电缆;a first coaxial cable connected to the first ultrasonic transducer;
与所述第二超声换能器连接的第二同轴电缆。A second coaxial cable connected to the second ultrasonic transducer.
优选的,在上述双频内窥导管中,所述第一超声换能器和所述第二超声换能器的结构相同,包括:Preferably, in the above-mentioned dual-frequency endoscopic catheter, the structure of the first ultrasonic transducer and the second ultrasonic transducer is the same, including:
背衬层;backing layer;
在第二方向上,依次位于所述背衬层一侧的第一电极层、压电层、第二电极层以及至少三层依次堆叠的声学人工匹配叠层;In the second direction, the first electrode layer, the piezoelectric layer, the second electrode layer and at least three successively stacked acoustic artificial matching laminates on one side of the backing layer;
其中,所述第二方向垂直于所述背衬层,且由所述背衬层指向所述第一电极层。Wherein, the second direction is perpendicular to the backing layer, and is directed from the backing layer to the first electrode layer.
优选的,在上述双频内窥导管中,所述第一超声换能器和所述第二超声换能器的结构相同,还包括:Preferably, in the above-mentioned dual-frequency endoscopic catheter, the structure of the first ultrasonic transducer and the second ultrasonic transducer are the same, further comprising:
位于所述第二电极层背离所述压电层一侧的导电层;a conductive layer located on a side of the second electrode layer away from the piezoelectric layer;
所述导电层与所述第二电极层紧邻设置。The conductive layer is adjacent to the second electrode layer.
优选的,在上述双频内窥导管中,所述背衬层背离所述第一电极层的一侧开设有凹槽。Preferably, in the above-mentioned dual-frequency endoscopic catheter, grooves are formed on the side of the backing layer away from the first electrode layer.
一种成像装置,所述成像装置包括:旋转回撤控制模块、数据采集模块、超声导管部件以及上位机;An imaging device, the imaging device comprising: a rotation retraction control module, a data acquisition module, an ultrasonic catheter component, and a host computer;
所述旋转回撤控制模块与所述数据采集模块通信连接;The rotation retraction control module is communicatively connected with the data acquisition module;
所述数据采集模块与所述上位机通信连接;The data acquisition module is communicatively connected with the host computer;
所述超声导管部件包括:近端驱动槽、导管鞘以及上述任一项所述的双频内窥导管;The ultrasonic catheter components include: a proximal drive slot, a catheter sheath, and the dual-frequency endoscopic catheter described in any one of the above;
所述近端驱动槽的一端与所述旋转回撤控制模块连接,另一端与所述导管鞘的一端连接;One end of the proximal drive slot is connected to the rotation retraction control module, and the other end is connected to one end of the catheter sheath;
所述双频内窥导管位于所述导管鞘内。The dual frequency endoscopic catheter is located within the introducer sheath.
有益效果Beneficial effect
本发明提供的一种双频内窥导管包括:外壳;位于所述外壳一侧的驱动部件,所述驱动部件用于带动所述外壳进行旋转;所述外壳的侧壁具有开口区域;位于所述开口区域内且延第一方向依次排列的第一超声换能器和第二超声换能器;其中,所述第一方向与所述外壳的长度延伸方向相同。A dual-frequency endoscopic catheter provided by the present invention includes: a casing; a driving part located on one side of the casing, and the driving part is used to drive the casing to rotate; the side wall of the casing has an opening area; The first ultrasonic transducer and the second ultrasonic transducer are arranged in sequence along the first direction in the opening area; wherein the first direction is the same as the length extension direction of the housing.
该双频内窥导管将两个超声换能器以设定的排布方式放置于导管内,两个换能器既可以同时或延时发射与接收超声脉冲,也可以单独发射与接收超声脉冲,通过将两种分辨能力的阵元有机结合以提供高质量的超声双频融合图像。The dual-frequency endoscopic catheter places two ultrasonic transducers in the catheter in a set arrangement, and the two transducers can transmit and receive ultrasonic pulses at the same time or with a delay, or can transmit and receive ultrasonic pulses independently , to provide high-quality ultrasonic dual-frequency fusion images by organically combining the array elements with two resolution capabilities.
利用相关理论与仿真设计的三层及三层以上的人工匹配层结构,采用高精度镀膜的方式来制作双频超声换能器的匹配层,有效提高换能器的输出带宽与响应幅值。Using the artificial matching layer structure of three or more layers designed by relevant theory and simulation, the matching layer of the dual-frequency ultrasonic transducer is made by high-precision coating, which effectively improves the output bandwidth and response amplitude of the transducer.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only It is an embodiment of the present invention, and those skilled in the art can also obtain other drawings according to the provided drawings without creative work.
图1为本发明实施例提供的一种成像装置的原理结构示意图;FIG. 1 is a schematic structural diagram of an imaging device provided by an embodiment of the present invention;
图2为本发明实施例提供的一种超声导管部件的结构示意图;Fig. 2 is a schematic structural diagram of an ultrasonic catheter component provided by an embodiment of the present invention;
图3为本发明实施例提供的一种导丝腔的结构示意图,导丝腔内设置有导丝;Fig. 3 is a schematic structural diagram of a guide wire cavity provided by an embodiment of the present invention, a guide wire is arranged in the guide wire cavity;
图4为本发明实施例提供的一种双频内窥导管的结构示意图;Fig. 4 is a schematic structural diagram of a dual-frequency endoscopic catheter provided by an embodiment of the present invention;
图5为本发明实施例提供的一种超声换能器的结构示意图;FIG. 5 is a schematic structural diagram of an ultrasonic transducer provided by an embodiment of the present invention;
图6为本发明实施例提供的一种图5所示超声换能器结构对应的连线示意图;Fig. 6 is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in Fig. 5 provided by an embodiment of the present invention;
图7为本发明实施例提供的另一种超声换能器的结构示意图;FIG. 7 is a schematic structural diagram of another ultrasonic transducer provided by an embodiment of the present invention;
图8为本发明实施例提供的一种图7所示超声换能器结构对应的连线示意图;Fig. 8 is a schematic diagram of the wiring corresponding to the structure of the ultrasonic transducer shown in Fig. 7 provided by an embodiment of the present invention;
图9为本发明实施例提供的一种双频内窥导管的制作方法流程示意图。Fig. 9 is a schematic flowchart of a method for manufacturing a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
本发明的实施方式Embodiments of the present invention
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
基于背景技术记载的内容而言,在本申请的发明创造过程中,发明人发现,相较于传统的单阵元超声内窥导管,双频超声内窥导管由于具有不同频率的两个超声换能器,其设计装配工艺一直是制约内窥超声成像技术发展的一大瓶颈。Based on the content of the background technology, during the invention and creation process of the present application, the inventor found that, compared with the traditional single-array ultrasonic endoscopic catheter, the dual-frequency ultrasonic endoscopic catheter has two ultrasonic transducers with different frequencies. The design and assembly process of the transducer has always been a major bottleneck restricting the development of endoscopic ultrasound imaging technology.
其中超声换能器的匹配层大多采用传统的单层或双层匹配,声阻抗匹配得不到很好的保证,使得超声换能器的输出带宽和幅值响应都不够高。Among them, the matching layer of the ultrasonic transducer mostly adopts traditional single-layer or double-layer matching, and the acoustic impedance matching cannot be well guaranteed, so that the output bandwidth and amplitude response of the ultrasonic transducer are not high enough.
此外,单个换能器的超声内窥导管的频率固定且单一,高频超声内窥镜导管成像分辨率高但成像深度很浅,低频超声内窥镜导管成像深度深但分辨率大为下降,制约着超声图像向高分辨率高成像深度的发展。In addition, the frequency of the ultrasonic endoscopic catheter with a single transducer is fixed and single, the imaging resolution of the high-frequency ultrasonic endoscopic catheter is high but the imaging depth is very shallow, and the imaging depth of the low-frequency ultrasonic endoscopic catheter is deep but the resolution is greatly reduced. It restricts the development of ultrasound images to high resolution and high imaging depth.
同时,单个换能器的超声内窥导管很难完成例如弹性成像等功能性超声成像的研究,制约着超声内窥导管向更加多元化的发展。At the same time, it is difficult for a single transducer ultrasonic endoscopic catheter to complete the research of functional ultrasonic imaging such as elastography, which restricts the development of more diversified ultrasonic endoscopic catheters.
基于此,在本申请中将两个超声换能器同侧并排放置于导管内,两个换能器既可以同时或延时发射与接收超声脉冲,也可以单独发射与接收超声脉冲,通过将两种分辨能力的阵元有机结合以提供高质量的超声图像。Based on this, in this application, two ultrasonic transducers are placed side by side in the catheter on the same side, and the two transducers can transmit and receive ultrasonic pulses at the same time or with a delay, and can also transmit and receive ultrasonic pulses independently. Array elements with two resolving powers are organically combined to provide high-quality ultrasound images.
进一步的,本申请利用相关理论与仿真设计的三层及三层以上的人工匹配层结构,采用高精度镀膜的方式来制作双频超声换能器的匹配层,有效提高换能器的输出带宽与响应幅值。Further, this application uses the artificial matching layer structure of three or more layers designed by relevant theories and simulations, and uses high-precision coating to make the matching layer of the dual-frequency ultrasonic transducer, effectively improving the output bandwidth of the transducer and response magnitude.
总的来说,本申请提供的技术方案利用超声双频阵元进行超声内窥弹性成像,可以实现超声成像与超声功能成像的结合,为临床诊断提供了更为可靠的依据。In general, the technical solution provided by this application uses ultrasonic dual-frequency array elements for ultrasonic endoscopic elastography, which can realize the combination of ultrasonic imaging and ultrasonic functional imaging, and provide a more reliable basis for clinical diagnosis.
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图和具体实施方式对本发明作进一步详细的说明。In order to make the above objects, features and advantages of the present invention more comprehensible, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.
参考图1,图1为本发明实施例提供的一种成像装置的原理结构示意图。Referring to FIG. 1 , FIG. 1 is a schematic structural diagram of an imaging device provided by an embodiment of the present invention.
所述成像装置包括:旋转回撤控制模块11、数据采集模块12、超声导管部件13以及上位机14。The imaging device includes: a rotation retraction control module 11 , a data acquisition module 12 , an ultrasound catheter component 13 and a host computer 14 .
所述旋转回撤控制模块11与所述数据采集模块12通信连接。The rotation retraction control module 11 is connected with the data acquisition module 12 in communication.
所述数据采集模块12与所述上位机14通信连接。The data acquisition module 12 is connected with the host computer 14 in communication.
具体的,所述旋转回撤控制模块11主要包括:电机、以及控制电机工作状态的控制模块。Specifically, the rotation retraction control module 11 mainly includes: a motor, and a control module for controlling the working state of the motor.
可选的,该电机至少包括旋转电机与回撤电机。Optionally, the motor at least includes a rotating motor and a retracting motor.
参考图2,图2为本发明实施例提供的一种超声导管部件的结构示意图。Referring to FIG. 2 , FIG. 2 is a schematic structural diagram of an ultrasonic catheter component provided by an embodiment of the present invention.
所述超声导管部件包括:近端驱动槽131、导管鞘132以及本申请下述实施例中所述的双频内窥导管133。The ultrasonic catheter components include: a proximal drive slot 131, a catheter sheath 132, and a dual-frequency endoscopic catheter 133 described in the following embodiments of this application.
所述近端驱动槽131的一端与所述旋转回撤控制模块11连接,另一端与所述导管鞘132的一端连接。One end of the proximal drive slot 131 is connected to the rotation retraction control module 11 , and the other end is connected to one end of the catheter sheath 132 .
所述双频内窥导管133位于所述导管鞘132内。The dual frequency endoscopic catheter 133 is located within the introducer sheath 132 .
其中,如图2所示,所述超声导管部件13还包括:位于所述导管鞘132上的回撤固定块134,以及远离近端驱动槽131的导丝腔135。Wherein, as shown in FIG. 2 , the ultrasound catheter component 13 further includes: a retraction fixing block 134 located on the catheter sheath 132 , and a guide wire lumen 135 away from the proximal driving groove 131 .
参考图3,图3为本发明实施例提供的一种导丝腔的结构示意图,导丝腔135内在手术中会预先穿入导丝。Referring to FIG. 3 , FIG. 3 is a schematic structural diagram of a guidewire lumen provided by an embodiment of the present invention. A guidewire is pre-threaded into the guidewire lumen 135 during surgery.
在该实施例中,近端驱动槽131与旋转回撤控制模块11中的旋转电机固定连接,再与旋转回撤控制模块11中的回撤部件相连,回撤时回撤固定块134静止。In this embodiment, the proximal drive slot 131 is fixedly connected to the rotating motor in the rotation retraction control module 11 , and then connected to the retraction component in the rotation retraction control module 11 , and the retraction fixing block 134 is stationary during retraction.
在本申请实施例中,以可回撤大于150mm的距离为例进行说明。In the embodiment of the present application, a retractable distance greater than 150mm is taken as an example for illustration.
如图2所示,该近端驱动槽131上还配置有注射腔136,通过注入生理盐水为双频内窥导管133内的超声换能器提供耦合环境并排空导管鞘内的空气。As shown in FIG. 2 , the proximal drive groove 131 is also provided with an injection cavity 136 , which provides a coupling environment for the ultrasonic transducer in the dual-frequency endoscopic catheter 133 and evacuates the air in the catheter sheath by injecting physiological saline.
可选的,导管鞘132以及导丝腔135均由生物性兼容材料制备。Optionally, both the introducer sheath 132 and the guide wire lumen 135 are made of biocompatible materials.
可选的,导管鞘132划分为靠近近端驱动槽131的部分以及靠近导丝腔135的部分;其中靠近近端驱动槽131部分的导管鞘132可以为硬质、非透明、高声阻抗的导管鞘132,靠近导丝腔135部分的导管鞘132可以为软质、透明、低声阻抗的导管鞘132作为成像窗口。Optionally, the catheter sheath 132 is divided into a part close to the proximal driving groove 131 and a part close to the guide wire lumen 135; wherein the catheter sheath 132 near the proximal driving groove 131 can be hard, non-transparent, and of high acoustic impedance The catheter sheath 132, the catheter sheath 132 near the guide wire lumen 135 can be a soft, transparent, low acoustic impedance catheter sheath 132 as an imaging window.
可选的,导管鞘132非透明部分的长度大于1m,成像窗口的长度大于150mm。Optionally, the length of the opaque portion of the catheter sheath 132 is greater than 1 m, and the length of the imaging window is greater than 150 mm.
在本发明其中一个实施例中,成像窗口的长度与回撤距离的最大距离相匹配。In one embodiment of the present invention, the length of the imaging window matches the maximum distance of the retraction distance.
例如,回撤距离的最大距离为300mm,那么成像窗口的长度也设置为300mm。For example, if the maximum retraction distance is 300mm, then the length of the imaging window is also set to 300mm.
进一步的,在本发明的一个实施例中,可以在回撤固定块134与近端驱动槽131之间的导管鞘132上设置刻度线,以衡量回撤距离,同时在旋转回撤模块上设置有回撤距离的数显板,通过刚性矫正算法矫正由于导管运动产生的非均匀畸变,以提供更加精确的超声内窥图像。Further, in one embodiment of the present invention, a scale line can be set on the catheter sheath 132 between the retraction fixing block 134 and the proximal driving groove 131 to measure the retraction distance, and at the same time, a scale line can be set on the rotation retraction module. The digital display board with a retraction distance corrects the non-uniform distortion caused by the movement of the catheter through a rigid correction algorithm to provide more accurate ultrasonic endoscopic images.
可选的,在本发明另一实施例中,参考图4,图4为本发明实施例提供的一种双频内窥导管的结构示意图。Optionally, in another embodiment of the present invention, refer to FIG. 4 , which is a schematic structural diagram of a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
所述双频内窥导管包括:The dual-frequency endoscopic catheter includes:
外壳15。shell15.
位于所述外壳15一侧的驱动部件16,所述驱动部件16用于带动所述外壳15进行旋转。The driving part 16 located on one side of the casing 15 is used to drive the casing 15 to rotate.
所述外壳15的侧壁具有开口区域。The side walls of the housing 15 have open areas.
位于所述开口区域内且延第一方向依次排列的第一超声换能器17和第二超声换能器18。可选的,所述第一超声换能器17和所述第二超声换能器18可同侧并排放置(即纵向排布),或同侧平行放置(即横向排布),或异侧并排放置(即纵向错位背靠背排布),或异侧背靠背放置等其它排列方式。The first ultrasonic transducer 17 and the second ultrasonic transducer 18 are located in the opening area and arranged in sequence along the first direction. Optionally, the first ultrasonic transducer 17 and the second ultrasonic transducer 18 can be placed side by side on the same side (that is, arranged longitudinally), or placed in parallel on the same side (that is, arranged horizontally), or placed on different sides Placed side by side (that is, vertically dislocated back-to-back arrangement), or other arrangements such as back-to-back placement on different sides.
其中,所述第一方向与所述外壳15的长度延伸方向相同。Wherein, the first direction is the same as the extending direction of the length of the housing 15 .
在该实施例中,该外壳15用于承载第一超声换能器17和第二超声换能器18,以及保护第一超声换能器17和第二超声换能器18。In this embodiment, the housing 15 is used to carry the first ultrasonic transducer 17 and the second ultrasonic transducer 18 and protect the first ultrasonic transducer 17 and the second ultrasonic transducer 18 .
其中,所述外壳15背离所述驱动部件16的一侧为子弹头形状,且外壳长度极短,该短子弹头形状的设计可以显著降低导管在弯曲以及回撤过程中产生的非均匀畸变。Wherein, the side of the casing 15 facing away from the driving part 16 is in the shape of a bullet, and the length of the casing is extremely short. The design of the short bullet shape can significantly reduce the non-uniform distortion of the catheter during bending and retraction.
可选的,该外壳15的材料包括但不限定于生物兼容性的金属材料或非金属材料,需具备强度高的特点,使其坚固耐用,以提高其使用寿命。Optionally, the material of the housing 15 includes but not limited to biocompatible metal materials or non-metal materials, which need to have high strength to make it durable and increase its service life.
可选的,如图4所示,所述双频内窥导管还包括:Optionally, as shown in Figure 4, the dual-frequency endoscopic catheter also includes:
位于所述开口区域内的底座19,且所述底座19与所述外壳15固定连接。The base 19 is located in the opening area, and the base 19 is fixedly connected with the shell 15 .
所述第一超声换能器17和所述第二超声换能器18固定在所述底座19上。The first ultrasonic transducer 17 and the second ultrasonic transducer 18 are fixed on the base 19 .
具体的,所述第一超声换能器17和所述第二超声换能器18通过底座19固定在外壳15内部。Specifically, the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are fixed inside the housing 15 through a base 19 .
该第一超声换能器17和第二超声换能器18包括但不限定于采用生物兼容性的胶水固定在底座19上,并且该生物兼容性的胶水还可以起到二者隔离绝缘的作用。The first ultrasonic transducer 17 and the second ultrasonic transducer 18 include but are not limited to being fixed on the base 19 with biocompatible glue, and the biocompatible glue can also play the role of isolation and insulation between the two .
其中,该底座19的设计可以极大程度提高第一超声换能器17和第二超声换能器18的同轴度和共面度。Wherein, the design of the base 19 can greatly improve the coaxiality and coplanarity of the first ultrasonic transducer 17 and the second ultrasonic transducer 18 .
可选的,该底座19的材料包括但不限定于生物兼容性的非金属材料(绝缘材料)。Optionally, the material of the base 19 includes but not limited to biocompatible non-metallic materials (insulating materials).
可选的,所述第一超声换能器17的频率为小于或等于40MHz;所述第二超声换能器18的频率为大于40MHz。Optionally, the frequency of the first ultrasonic transducer 17 is less than or equal to 40 MHz; the frequency of the second ultrasonic transducer 18 is greater than 40 MHz.
也就是说,在本申请实施例中,以两个频率不同的超声换能器为例进行说明,其中第一超声换能器17为低频超声换能器,第二超声换能器18为高频超声换能器。That is to say, in this embodiment of the application, two ultrasonic transducers with different frequencies are taken as an example for illustration, wherein the first ultrasonic transducer 17 is a low-frequency ultrasonic transducer, and the second ultrasonic transducer 18 is a high-frequency ultrasonic transducer. frequency ultrasonic transducer.
可选的,如图4所示,所述驱动部件16为力矩线圈。Optionally, as shown in FIG. 4 , the driving component 16 is a torque coil.
所述力矩线圈的线圈层数为至少两层,三层或三层以上更佳。The number of coil layers of the torque coil is at least two layers, preferably three layers or more.
其中,外壳15与力矩线圈16包括但不限定于通过生物兼容性胶水、导电银胶或激光焊接等方式进行连接固定,该力矩线圈用于传导旋转电机产生的扭矩。Wherein, the casing 15 and the torque coil 16 include but are not limited to be connected and fixed by means of biocompatible glue, conductive silver glue or laser welding, and the torque coil is used to transmit the torque generated by the rotating motor.
在本申请实施例中,该力矩线圈的线圈层数为至少三层,以实现可以顺时针或逆时针两个方向的旋转,且具有优良的弯曲性能,抗抖动性能以及安全性能。In the embodiment of the present application, the torque coil has at least three layers of coils to achieve rotation in two directions, clockwise or counterclockwise, and has excellent bending performance, anti-shaking performance and safety performance.
其中,该双频内窥导管放置在导管鞘内,且第一超声换能器17和第二超声换能器18所在区域对应导管鞘的成像窗口。Wherein, the dual-frequency endoscopic catheter is placed in the catheter sheath, and the area where the first ultrasonic transducer 17 and the second ultrasonic transducer 18 are located corresponds to the imaging window of the catheter sheath.
可选的,如图4所示,所述双频内窥导管还包括:Optionally, as shown in Figure 4, the dual-frequency endoscopic catheter also includes:
与所述第一超声换能器17连接的第一同轴电缆20。A first coaxial cable 20 connected to the first ultrasonic transducer 17 .
与所述第二超声换能器18连接的第二同轴电缆21。A second coaxial cable 21 connected to the second ultrasonic transducer 18 .
其中,第一同轴电缆20和第二同轴电缆21通过力矩线圈的中空区域分别与第一超声换能器17和第二超声换能器18等部件连接。Wherein, the first coaxial cable 20 and the second coaxial cable 21 are respectively connected to components such as the first ultrasonic transducer 17 and the second ultrasonic transducer 18 through the hollow area of the torque coil.
工作时,导管鞘、导丝腔以及导丝均保持静止,双频内窥导管进行旋转和/或回撤动作。During operation, the introducer sheath, the guidewire lumen and the guidewire remain stationary, and the dual-frequency endoscopic catheter rotates and/or retracts.
可选的,在本发明另一实施例中,参考图5,图5为本发明实施例提供的一种超声换能器的结构示意图。Optionally, in another embodiment of the present invention, refer to FIG. 5 , which is a schematic structural diagram of an ultrasonic transducer provided in an embodiment of the present invention.
所述第一超声换能器17和所述第二超声换能器18的结构相同,包括:The first ultrasonic transducer 17 has the same structure as the second ultrasonic transducer 18, including:
背衬层22。backing layer 22 .
在第二方向上,依次位于所述背衬层22一侧的第一电极层23、压电层24、第二电极层25以及至少三层依次堆叠的声学人工匹配叠层26。In the second direction, the first electrode layer 23 , the piezoelectric layer 24 , the second electrode layer 25 and at least three layers of acoustic artificial matching laminates 26 are sequentially stacked on one side of the backing layer 22 .
其中,所述第二方向垂直于所述背衬层22,且由所述背衬层22指向所述第一电极层23。Wherein, the second direction is perpendicular to the backing layer 22 and is directed from the backing layer 22 to the first electrode layer 23 .
在该实施例中,使用具备优越压电即介电性能的压电单晶材料或者压电单晶复合材料其中一种或多种(如PMN-PT 单晶材料)进行第一超声换能器17和第二超声换能器18的开发。In this embodiment, one or more of piezoelectric single crystal materials or piezoelectric single crystal composite materials (such as PMN-PT single crystal material) with superior piezoelectric or dielectric properties are used to implement the first ultrasonic transducer 17 and the development of a second ultrasound transducer 18 .
可选的,利用高吸声性能材料(如E-Solder 3022或者钨钢)制备第一超声换能器17和第二超声换能器18的背衬层22,以进一步减小第一超声换能器17和第二超声换能器18的阵元厚度,使双频内窥导管的外径尺寸处于0.2mm-10mm左右,更便于进入空间狭小且深入的心血管结构内进行内窥成像。Optionally, the backing layer 22 of the first ultrasonic transducer 17 and the second ultrasonic transducer 18 is prepared by using a material with high sound absorption performance (such as E-Solder 3022 or tungsten steel), so as to further reduce the The array element thickness of the transducer 17 and the second ultrasonic transducer 18 makes the outer diameter of the dual-frequency endoscopic catheter about 0.2mm-10mm, which is more convenient for endoscopic imaging in narrow and deep cardiovascular structures.
其中,第一电极层23的材料包括但不限于Cr/Au材料。(电极层是先镀镍铬,再镀金,保障电极更加牢固)。Wherein, the material of the first electrode layer 23 includes but not limited to Cr/Au material. (The electrode layer is first plated with nickel and chromium, and then gold-plated to ensure that the electrode is more firm).
第二电极层25的材料包括但不限定于Cr/Au材料。The material of the second electrode layer 25 includes but not limited to Cr/Au material.
可选的,至少三层依次堆叠的声学人工匹配叠层26包括在第二方向上依次堆叠设置的第一声学人工匹配层A1和第二声学人工匹配层A2;通过第一声学人工匹配层A1和第二声学人工匹配层A2在第二方向上依次堆叠形成至少三层依次堆叠的声学人工匹配叠层26。Optionally, at least three successively stacked acoustic artificial matching layers 26 include a first acoustic artificial matching layer A1 and a second acoustic artificial matching layer A2 which are sequentially stacked in the second direction; through the first acoustic artificial matching The layer A1 and the second acoustic artificial matching layer A2 are sequentially stacked in the second direction to form at least three sequentially stacked acoustic artificial matching laminates 26 .
可选的,第一声学人工匹配层A1的材料可以为聚合物材料,例如聚对二甲苯等。Optionally, the material of the first artificial acoustic matching layer A1 may be a polymer material, such as parylene or the like.
可选的,第二声学人工匹配层A2的材料可以为高分子材质或金属材料,例如金等金属材料。Optionally, the material of the second acoustic artificial matching layer A2 may be a polymer material or a metal material, such as gold and other metal materials.
可选的,所述压电层24可以为压电陶瓷、压电陶瓷复合材质、压点单晶材质或压电单晶复合材质。Optionally, the piezoelectric layer 24 may be piezoelectric ceramics, piezoelectric ceramic composite material, pressure-point single crystal material or piezoelectric single crystal composite material.
可选的,所述背衬层22背离所述第一电极层23的一侧开设有凹槽27。Optionally, a groove 27 is formed on a side of the backing layer 22 away from the first electrode layer 23 .
进一步的,参考图6,图6为本发明实施例提供的一种图5所示超声换能器结构对应的连线示意图。Further, refer to FIG. 6 , which is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in FIG. 5 provided by an embodiment of the present invention.
其中,同轴电缆与第二电极层连接。Wherein, the coaxial cable is connected with the second electrode layer.
可选的,在本发明另一实施例中,参考图7,图7为本发明实施例提供的另一种超声换能器的结构示意图。Optionally, in another embodiment of the present invention, refer to FIG. 7 , which is a schematic structural diagram of another ultrasonic transducer provided in an embodiment of the present invention.
所述第一超声换能器17和所述第二超声换能器18的结构相同,还包括:The first ultrasonic transducer 17 has the same structure as the second ultrasonic transducer 18, and also includes:
位于所述第二电极层25背离所述压电层24一侧的导电层28;a conductive layer 28 located on the side of the second electrode layer 25 away from the piezoelectric layer 24;
所述导电层28与所述第二电极层25紧邻设置。The conductive layer 28 is adjacent to the second electrode layer 25 .
在该实施例中,在图5所示超声换能器结构的基础上,还可以在所述第二电极层25背离所述压电层24的一侧形成一层导电层28。In this embodiment, on the basis of the ultrasonic transducer structure shown in FIG. 5 , a conductive layer 28 may also be formed on the side of the second electrode layer 25 away from the piezoelectric layer 24 .
可选的,导电层28的材料包括但不限定于金等金属材料。Optionally, the material of the conductive layer 28 includes, but is not limited to, metal materials such as gold.
进一步的,参考图8,图8为本发明实施例提供的一种图7所示超声换能器结构对应的连线示意图。Further, refer to FIG. 8 , which is a schematic diagram of wiring corresponding to the structure of the ultrasonic transducer shown in FIG. 7 provided by an embodiment of the present invention.
其中,导电层28与金属外壳连接,金属外壳与同轴电缆的屏蔽端连接。Wherein, the conductive layer 28 is connected to the metal shell, and the metal shell is connected to the shielding end of the coaxial cable.
需要说明的是,图5-图8中,声学人工匹配叠层26仅仅以三层膜层数量为例进行说明。It should be noted that, in FIGS. 5-8 , the acoustic artificial matching laminate 26 is only described by taking the number of three film layers as an example.
通过上述描述可知,在本申请中第一超声换能器和第二超声换能器结合理论与仿真结合的三层及三层以上的声学人工匹配叠层进行制作,实现更高分辨率、更高信噪比以及更高灵敏度的双频率多尺度成像导管的一体化集成;通过图6和图8的两种连线方式实现了第一超声换能器和第二超声换能器正负极的连接。From the above description, it can be seen that in this application, the first ultrasonic transducer and the second ultrasonic transducer are manufactured by combining theory and simulation with three or more layers of acoustic artificial matching laminates to achieve higher resolution and higher resolution. Integrated integration of dual-frequency multi-scale imaging catheter with high signal-to-noise ratio and higher sensitivity; the positive and negative poles of the first ultrasonic transducer and the second ultrasonic transducer are realized through the two connection methods shown in Figure 6 and Figure 8 Connection.
可选的,基于本发明上述实施例提供的双频内窥导管,下面对其制作过程进行简单阐述,仅仅作为一个示例进行说明:Optionally, based on the dual-frequency endoscopic catheter provided by the above-mentioned embodiments of the present invention, the manufacturing process thereof is briefly described below, which is only used as an example for illustration:
参考图9,图9为本发明实施例提供的一种双频内窥导管的制作方法流程示意图。Referring to FIG. 9 , FIG. 9 is a schematic flowchart of a method for manufacturing a dual-frequency endoscopic catheter provided by an embodiment of the present invention.
S101:利用PiezoCAD仿真确定各压电层、各层声学人工匹配层的厚度以及各超声换能器尺寸。S101: Using PiezoCAD simulation to determine the thickness of each piezoelectric layer, each acoustic artificial matching layer, and the size of each ultrasonic transducer.
S102:分别抛光研磨压电材料至仿真计算的厚度。S102: respectively polishing and grinding the piezoelectric material to a thickness calculated by simulation.
S103:利用磁控溅射仪在抛光研磨后的压电材料前后两面分别设置镍铬/金电极材料。S103: using a magnetron sputtering apparatus to respectively arrange nickel-chromium/gold electrode materials on the front and rear surfaces of the polished piezoelectric material.
S104:利用精密金刚石切割机将上述双频阵元切割至仿真设计的尺寸。S104: Using a precision diamond cutting machine to cut the above-mentioned dual-frequency array element to the size of the simulation design.
S105:利用E-Solder 3022材料进行阵元的连线,并用Epo-Tek 301环氧树脂材料将双频阵元置于底座上,并封装于外壳内部。S105: Use E-Solder 3022 material to connect the array element, and use Epo-Tek 301 epoxy resin material to place the dual-frequency array element on the base and encapsulate it inside the shell.
S106:将多层声学人工匹配层材料设置于阵元的前向声辐射面。S106: Arranging multiple layers of acoustic artificial matching layer material on the forward acoustic radiation surface of the array element.
需要说明的是,由于两个阵元匹配层厚度不一致,需要对厚度要求低的阵元做人工遮挡处理。(对于图8而言)It should be noted that since the thickness of the matching layer of the two array elements is inconsistent, it is necessary to perform manual occlusion processing on the array elements with low thickness requirements. (for Figure 8)
由于两个阵元匹配层厚度不一致,对两种不同阵元分别进行镀人工声学结构处理再装配进入外壳中,以获得最佳的声学匹配。(对于图6而言)Due to the inconsistent thickness of the matching layers of the two array elements, the two different array elements are respectively plated with artificial acoustic structures and then assembled into the shell to obtain the best acoustic matching. (for Figure 6)
以上对本发明所提供的一种双频内窥导管及成像装置进行了详细介绍,本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本发明的限制。A dual-frequency endoscopic catheter and an imaging device provided by the present invention have been introduced in detail above. In this paper, specific examples are used to illustrate the principle and implementation of the present invention. The description of the above embodiments is only used to help understand the present invention. The method of the invention and its core idea; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation and scope of application. In summary, the content of this specification should not be understood To limit the present invention.
需要说明的是,本说明书中的各个实施例均采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似的部分互相参见即可。对于实施例公开的装置而言,由于其与实施例公开的方法相对应,所以描述的比较简单,相关之处参见方法部分说明即可。It should be noted that each embodiment in this specification is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. For the same and similar parts in each embodiment, refer to each other, that is, Can. As for the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and for relevant details, please refer to the description of the method part.
还需要说明的是,在本文中,诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来,而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备所固有的要素,或者是还包括为这些过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。It should also be noted that in this article, relational terms such as first and second etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that these entities or operations Any such actual relationship or order exists between. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that elements inherent in a process, method, article, or apparatus comprising a set of elements are included or are also included as such , a method, an article or an element inherent in a device. Without further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising said element.
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

  1. 一种双频内窥导管,其特征在于,所述双频内窥导管包括:A dual-frequency endoscopic catheter, characterized in that the dual-frequency endoscopic catheter includes:
    外壳;shell;
    位于所述外壳一侧的驱动部件,所述驱动部件用于带动所述外壳进行旋转;a driving component located on one side of the housing, the driving component is used to drive the housing to rotate;
    所述外壳的侧壁具有开口区域;The sidewall of the housing has an open area;
    位于所述开口区域内且延第一方向依次排列的第一超声换能器和第二超声换能器;a first ultrasonic transducer and a second ultrasonic transducer located in the opening area and arranged in sequence along the first direction;
    其中,所述第一方向与所述外壳的长度延伸方向相同。Wherein, the first direction is the same as the length extension direction of the housing.
  2. 根据权利要求1所述的双频内窥导管,其特征在于,所述第一超声换能器的频率为小于或等于40MHz;The dual-frequency endoscopic catheter according to claim 1, wherein the frequency of the first ultrasonic transducer is less than or equal to 40MHz;
    所述第二超声换能器的频率为大于40MHz。The frequency of the second ultrasonic transducer is greater than 40MHz.
  3. 根据权利要求1所述的双频内窥导管,其特征在于,所述双频内窥导管还包括:The dual-frequency endoscopic catheter according to claim 1, wherein the dual-frequency endoscopic catheter further comprises:
    位于所述开口区域内的底座,且所述底座与所述外壳固定连接;a base located in the opening area, and the base is fixedly connected to the housing;
    所述第一超声换能器和所述第二超声换能器固定在所述底座上。The first ultrasonic transducer and the second ultrasonic transducer are fixed on the base.
  4. 根据权利要求1所述的双频内窥导管,其特征在于,所述外壳背离所述驱动部件的一侧为子弹头形状。The dual-frequency endoscopic catheter according to claim 1, wherein the side of the casing facing away from the driving part is in the shape of a bullet.
  5. 根据权利要求1所述的双频内窥导管,其特征在于,所述驱动部件为力矩线圈;The dual-frequency endoscopic catheter according to claim 1, wherein the driving component is a torque coil;
    所述力矩线圈的线圈层数为至少两层。The number of coil layers of the torque coil is at least two layers.
  6. 根据权利要求1所述的双频内窥导管,其特征在于,所述双频内窥导管还包括:The dual-frequency endoscopic catheter according to claim 1, wherein the dual-frequency endoscopic catheter further comprises:
    与所述第一超声换能器连接的第一同轴电缆;a first coaxial cable connected to the first ultrasonic transducer;
    与所述第二超声换能器连接的第二同轴电缆。A second coaxial cable connected to the second ultrasonic transducer.
  7. 根据权利要求1所述的双频内窥导管,其特征在于,所述第一超声换能器和所述第二超声换能器的结构相同,包括:The dual-frequency endoscopic catheter according to claim 1, wherein the first ultrasonic transducer and the second ultrasonic transducer have the same structure, including:
    背衬层;backing layer;
    在第二方向上,依次位于所述背衬层一侧的第一电极层、压电层、第二电极层以及至少三层依次堆叠的声学人工匹配叠层;In the second direction, the first electrode layer, the piezoelectric layer, the second electrode layer and at least three successively stacked acoustic artificial matching laminates on one side of the backing layer;
    其中,所述第二方向垂直于所述背衬层,且由所述背衬层指向所述第一电极层。Wherein, the second direction is perpendicular to the backing layer, and is directed from the backing layer to the first electrode layer.
  8. 根据权利要求7所述的双频内窥导管,其特征在于,所述第一超声换能器和所述第二超声换能器的结构相同,还包括:The dual-frequency endoscopic catheter according to claim 7, wherein the structure of the first ultrasonic transducer and the second ultrasonic transducer is the same, further comprising:
    位于所述第二电极层背离所述压电层一侧的导电层;a conductive layer located on a side of the second electrode layer away from the piezoelectric layer;
    所述导电层与所述第二电极层紧邻设置。The conductive layer is adjacent to the second electrode layer.
  9. 根据权利要求7所述的双频内窥导管,其特征在于,所述背衬层背离所述第一电极层的一侧开设有凹槽。The dual-frequency endoscopic catheter according to claim 7, characterized in that grooves are formed on the side of the backing layer away from the first electrode layer.
  10. 一种成像装置,其特征在于,所述成像装置包括:旋转回撤控制模块、数据采集模块、超声导管部件以及上位机;An imaging device, characterized in that the imaging device includes: a rotation retraction control module, a data acquisition module, an ultrasonic catheter component, and a host computer;
    所述旋转回撤控制模块与所述数据采集模块通信连接;The rotation retraction control module is communicatively connected with the data acquisition module;
    所述数据采集模块与所述上位机通信连接;The data acquisition module is communicatively connected with the host computer;
    所述超声导管部件包括:近端驱动槽、导管鞘以及权利要求1-9任一项所述的双频内窥导管;The ultrasonic catheter components include: a proximal drive slot, a catheter sheath, and the dual-frequency endoscopic catheter according to any one of claims 1-9;
    所述近端驱动槽的一端与所述旋转回撤控制模块连接,另一端与所述导管鞘的一端连接;One end of the proximal drive slot is connected to the rotation retraction control module, and the other end is connected to one end of the catheter sheath;
    所述双频内窥导管位于所述导管鞘内。The dual frequency endoscopic catheter is located within the introducer sheath.
PCT/CN2021/138045 2021-11-30 2021-12-14 Dual-frequency endoscopic catheter and imaging device WO2023097784A1 (en)

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