阅读说明：本技术 一种超声波器件及超声成像导管 (Ultrasonic device and ultrasonic imaging catheter ) 是由 刘斌 于 2021-07-16 设计创作，主要内容包括：本申请提供了一种超声波器件,包括多个呈矩形阵列排布的换能器阵元,相邻换能器阵元之间的间距不大于目标超声工作频率对应的波长,每个换能器阵元通过CMOS大规模制造工艺集成了对应的发射模拟前端电路和接收模拟前端电路；本申请还提供了一种超声成像导管,包括导管本体和设置在导管本体一端的超声波器件。本申请提供的超声波器件,通过在换能器阵元集成了接收模拟前端电路,降低了寄生电容和链路损耗,提升了成像电信号的信噪比,使三维超声影像具备更好的分辨率和测量准确度；本申请提供的超声成像导管能够提大幅提升心腔内目标组织结构的测量效率和准确度,以及在术中对心室辅助装置等植介入器械的定位精度,帮助医生更加准确地评价治疗效果。(The application provides an ultrasonic device which comprises a plurality of transducer array elements arranged in a rectangular array, wherein the distance between adjacent transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and each transducer array element is integrated with a corresponding transmitting analog front-end circuit and a corresponding receiving analog front-end circuit through a CMOS (complementary metal oxide semiconductor) large-scale manufacturing process; the application also provides an ultrasonic imaging catheter, which comprises a catheter body and an ultrasonic device arranged at one end of the catheter body. According to the ultrasonic device, the receiving analog front-end circuit is integrated on the transducer array element, so that parasitic capacitance and link loss are reduced, the signal to noise ratio of an imaging electric signal is improved, and a three-dimensional ultrasonic image has better resolution and measurement accuracy; the ultrasonic imaging catheter provided by the application can improve the measurement efficiency and accuracy of a target tissue structure in a heart cavity, and can help a doctor to evaluate the treatment effect more accurately in the positioning precision of implantation intervention instruments such as a ventricular assist device in an operation.)

1. An ultrasonic device, comprising a plurality of transducer array elements arranged in a rectangular array; the distance between adjacent transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and a transmitting analog front-end circuit and a receiving analog front-end circuit are integrated on each transducer array element through a CMOS large-scale manufacturing process; the transmitting analog front-end circuit is used for generating ultrasonic waves; the receiving analog front-end circuit is used for converting the ultrasonic echo signals into electric signals.

2. An ultrasonic device as claimed in claim 1 further comprising a logic control module and analog to digital conversion circuitry module for three dimensional ultrasonic scanning and outputting real time three dimensional ultrasonic imaging electrical signals.

3. An ultrasonic device as claimed in claim 1, wherein the transducer element comprises four transducer elements connected in parallel in sequence, the transducer elements adopt a diaphragm structure and comprise a top electrode, a bottom electrode and a vacuum cavity below the diaphragm, and a passive layer material is arranged above the top electrode; and the top electrode and the bottom electrode of each transducer unit are electrically connected in a one-to-one correspondence manner.

4. The ultrasonic device of claim 3, wherein the transmit analog front end circuit comprises a driver circuit and a dc bias voltage line; the direct current bias voltage circuit is used for enabling the energy converter unit to be in a pull-in working mode; the driver circuit transmits an alternating current excitation signal to the energy converter unit, so that the vibration film in the energy converter unit vibrates to generate ultrasonic waves.

5. The ultrasonic device of claim 4, wherein the dc bias voltage in the dc bias voltage line does not exceed 150V.

6. An ultrasonic device as claimed in claim 1 wherein: the receiving analog front-end circuit comprises a switch circuit and a trans-impedance amplifier circuit; the switch circuit opens or closes a receiving signal channel; the transimpedance amplifier circuit comprises a CSA charge-sensitive amplifier and is used for converting a weak current signal generated by ultrasonic echo into a voltage signal and amplifying a low-noise signal.

7. An ultrasound imaging catheter, characterized by: comprising a catheter body (1) and an ultrasound device as claimed in any of claims 1-6, said ultrasound device being mounted at a first end of said catheter body.

8. The ultrasound imaging catheter of claim 7, wherein: also comprises an operating handle (3); the operating handle (3) is arranged at the second end of the catheter body (1).

9. The ultrasound imaging catheter of claim 8, wherein: the catheter body (1) is a bendable catheter; a plurality of traction wires (4) are arranged in the catheter body (1); one end of the traction wire (4) is fixedly connected with the first end of the catheter body (1); the other end of the traction wire (4) is movably connected with the operating handle (3).

10. The ultrasound imaging catheter of claim 8 or 9, wherein: still include transmission wire (7), transmission wire (7) are followed the inside cavity of pipe body (1) arranges, transmission wire (7) one end with ultrasonic device (2) are connected, transmission wire (7) other end is used for external supersound imaging equipment.

Technical Field

The application belongs to the technical field of structural heart disease treatment equipment, and particularly relates to an ultrasonic device and an ultrasonic imaging catheter.

Background

Structural Heart Disease (SHD) is the most rapidly developing field of cardiovascular intervention in recent years. As new technologies for treating structural heart disease continue to be developed and popularized worldwide, the concept of structural heart disease is increasingly well known to the cardiology, other specialists, and the social public. Structural heart disease refers to any disease related to the heart and the large blood vessel structures adjacent to the heart, except for heart electrical diseases and coronary artery diseases, and is characterized in that the disease can be treated by correcting or changing the heart structures. Specific disease categories include:

(1) congenital heart disease (ventricular septal defect, atrial septal defect, patent ductus arteriosus, etc.);

(2) valvular heart diseases (mitral, tricuspid, aortic, pulmonary, etc.);

(3) cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);

(4) abnormalities which cause heart function and are complicated with other diseases, such as left atrial appendage dysfunction caused by atrial fibrillation;

(5) and others: thrombosis in heart, heart tumor, pericardial disease, etc.

Structural heart disease treatment includes drug therapy, surgery, and interventional therapy. Currently, interventional therapy is the most important development direction for structural heart disease, and specific vascular interventional therapy techniques include:

(1) transcatheter occlusion of congenital heart disease;

(2) traditional transcatheter valve therapies: mainly percutaneous mitral valve balloon dilatation (PBMV), percutaneous pulmonary valve balloon dilatation (PBPV), and percutaneous aortic valve balloon dilatation (PBAV), transcatheter arterial paravalvular occlusion, etc.;

(3) emerging transcatheter valve therapies: transcatheter Aortic Valve Replacement (TAVR), Percutaneous pulmonary Valve placement (PPVI), Transcatheter edge-to-edge mitral Valve repair (TEER), Transcatheter mitral Valve placement (TMVI), Transcatheter tricuspid Valve intervention, and the like.

(4) Transcatheter left atrial appendage occlusion (Transcatheter left atrial appendage occlusion);

(5) interventional treatment of cardiomyopathy: including alcohol ablation (PTSMA) or radiofrequency ablation of hypertrophic cardiomyopathy;

(6) interventional treatment of heart failure: left ventricular volume reduction, atrial shunt, transcatheter ventricular assist devices, and the like.

Since the use of X-rays is minimized during the operation to the maximum extent and the patient and the doctor can be effectively protected, echocardiogram is becoming a very important image-assisted technique in the field of interventional therapy. Since the application of Transesophageal Echocardiography (TEE) in the clinic in 1987, it not only provides a new window approach for the ultrasonic diagnosis of heart diseases, but also plays an important role in the treatment of structural heart diseases. In the interventional operation process of oval hole plugging, valve repair/replacement, left atrial appendage plugging and the like, the TEE probe is placed into the esophagus or the stomach and is connected with a host image processing system, the structure and the function of the heart and the blood vessels can be dynamically observed in multiple angles, long and short axes and multiple sections, and the related hemodynamic indexes in the heart cavity can be continuously monitored. Therefore, the TEE is not only suitable for preoperative diagnosis and intraoperative guidance of the structural heart disease, but also can be used as a vital means for evaluating whether the operation is successful, evaluating the structure and the function of the valve, dynamically monitoring the function of the heart in the operation and the like. However, TEE transesophageal ultrasound also suffers from some significant drawbacks, as follows:

1) TEE probes are typically used under general anesthesia in patients, otherwise intubating discomfort can occur;

2) the diameter of the esophagus ultrasonic probe is thick, about 9-15mm, and the esophagus ultrasonic probe has certain traumatism in the operation;

3) the trachea is clamped between the upper esophagus section and the heart, and the heart bottom structure at the front side of the trachea, such as the upper ascending aorta section, the proximal aortic arch section, the upper superior vena cava section and the like, cannot be displayed, so that a blind area which is difficult to exceed is formed;

4) when the esophagus ultrasonic probe inspects a far field, the resolution ratio is reduced due to the attenuation of sound energy, so that the display of structures for detecting the right ventricle, the pulmonary valve and the like is poor;

in recent years, to solve the drawbacks of transesophageal ultrasound (TEE) technology, transcatheter Echocardiography (ICE) technology has been proposed in the industry. Compared with the traditional transesophageal ultrasound (TEE), the intracardiac ultrasonic Imaging (ICE) catheter can adopt a bendable catheter, and the ultrasonic probe is not limited by an imaging window and can flexibly adjust the spatial position and the imaging angle; the ultrasonic probe is directly coupled with blood and is not influenced by gas medium, so that the acoustic energy attenuation is reduced, and the detection depth and the image resolution are improved; an intracardiac ultrasonic Imaging (ICE) catheter is delivered into the cardiac chamber of a patient through femoral vein puncture, general anesthesia is not needed, and discomfort of intubation is avoided.

At present, an intracardiac ultrasonic Imaging (ICE) catheter in the industry only supports a two-dimensional ultrasonic image, and for operations such as foramen ovale blocking, interatrial septum blocking, left atrial appendage blocking, mitral valve repair/replacement and the like, ultrasonic two-dimensional scanning at a plurality of angles is required to be performed step by step to obtain the complete size and shape of target tissues such as the left atrial appendage and the like, so that the catheter is complex in operation aspect, and more operation time is required to be consumed. Therefore, a three-dimensional ultrasonic imaging technology and an imaging catheter scheme in a heart cavity are urgently needed in clinic, and the purposes of greatly improving the precision of preoperative evaluation and intraoperative guidance, the treatment effect and the operation efficiency are achieved by efficiently acquiring three-dimensional structure images of target tissues such as the oval hole, the left atrial appendage and the heart valve.

Disclosure of Invention

An object of the embodiment of the present application is to provide an ultrasonic device and an ultrasonic imaging catheter, so as to solve the technical problem that three-dimensional structure and contour data of a specific tissue in a cardiac chamber cannot be timely and efficiently acquired in the existing two-dimensional intracardiac ultrasonic Imaging (ICE) technology.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: providing an ultrasonic device supporting three-dimensional ultrasonic imaging, which comprises a plurality of transducer array elements arranged in a rectangular array; the distance between adjacent transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and a transmitting analog front-end circuit and a receiving analog front-end circuit are integrated on each transducer array element through a CMOS large-scale manufacturing process; the transmitting analog front-end circuit is used for generating ultrasonic waves; the receiving analog front-end circuit is used for converting the ultrasonic echo signals into electric signals.

Optionally, the ultrasonic device further includes a logic control module and an analog-to-digital conversion circuit module, which are used for three-dimensional ultrasonic scanning and outputting a real-time three-dimensional ultrasonic imaging electrical signal.

Optionally, the transducer array includes four transducer units connected in parallel in sequence, the transducer units adopt a diaphragm structure, and include a top electrode, a bottom electrode and a vacuum cavity below the diaphragm, and a passive layer material is disposed above the top electrode; and the top electrode and the bottom electrode of each transducer unit are electrically connected in a one-to-one correspondence manner.

Optionally, the transmit analog front end circuit comprises a driver circuit and a dc bias voltage line; the direct current bias voltage circuit is used for enabling the energy converter unit to be in a pull-in working mode; the driver circuit transmits an alternating current excitation signal to the energy converter unit, so that the vibration film in the energy converter unit vibrates to generate ultrasonic waves.

Optionally, the dc bias voltage in the dc bias voltage line does not exceed 150V.

Optionally, the receiving analog front-end circuit comprises a switching circuit and a transimpedance amplifier circuit; the switch circuit opens or closes a receiving signal channel; the transimpedance amplifier circuit comprises a CSA charge-sensitive amplifier and is used for converting a weak current signal generated by ultrasonic echo into a voltage signal and amplifying a low-noise signal.

The application also provides an ultrasonic imaging catheter supporting three-dimensional ultrasonic imaging, which comprises a catheter body and the ultrasonic device, wherein the ultrasonic device is arranged at the first end of the catheter body.

Optionally, the ultrasound imaging catheter further comprises an operating handle; the operating handle is arranged at the second end of the catheter body.

Optionally, the catheter body is a bendable catheter; a plurality of traction wires are arranged in the catheter body; one end of the traction wire is fixedly connected with the first end of the catheter body; the other end of the traction wire is movably connected with the operating handle.

Optionally, the ultrasound imaging catheter further comprises a transmission wire, the transmission wire is arranged along the inner cavity of the catheter body, one end of the transmission wire is connected with the ultrasonic device, and the other end of the transmission wire is used for being externally connected with ultrasound imaging equipment.

The ultrasonic device provided by the application has the beneficial effects that: the ultrasonic echo signal processing method adopts a plurality of transducer array elements which are arranged in a rectangular array, the distance between the transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and the smaller the distance between the transducer array elements is, the sidelobe energy in an ultrasonic sound field can be effectively reduced, so that the main lobe energy is enhanced, and the ultrasonic echo signal can obtain a better signal-to-noise ratio; by integrating the transmitting analog front-end circuit and the receiving analog front-end circuit, ultrasonic wave transmitting and echo receiving of a plurality of transducer array elements can be automatically completed, parasitic capacitance and link loss are reduced, and the signal-to-noise ratio, the signal processing efficiency and the image resolution of imaging electric signals are improved.

The ultrasonic imaging catheter provided by the application has the beneficial effects that: the utility model provides an ultrasonic imaging pipe can provide real-time three-dimensional digital ultrasonic imaging signal of telecommunication, can generate three-dimensional ultrasonic image through direct digital signal processing, can promote the measurement of efficiency and the degree of accuracy of target organizational structure (such as oval hole, left auricle, mitral valve etc.) in the heart chamber simultaneously by a wide margin to and to the positioning accuracy of implanting intervention apparatus such as occluder, artificial valve, ablation pipe and ventricle auxiliary device in the art, help the doctor to evaluate treatment more accurately.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.

Fig. 1 is a schematic structural diagram of an ultrasonic device provided in an embodiment of the present application;

FIG. 2 is a schematic structural diagram of an ultrasound imaging catheter provided in an embodiment of the present application;

fig. 3 is a partially enlarged view of a in fig. 2.

Wherein, in the figures, the respective reference numerals:

1-a catheter body; 2-an ultrasonic device; 3-operating a handle; 4-drawing a wire; 5-an identification module; 6-knob; 7-a transmission wire; 8-connector.

Detailed Description

In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application clearer, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered as limiting the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

Referring to fig. 1 to 3 together, an ultrasonic device and an ultrasonic imaging catheter provided in an embodiment of the present application will now be described. The ultrasonic device comprises a plurality of transducer array elements which are arranged in a rectangular array; the distance between adjacent transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and a transmitting analog front-end circuit and a receiving analog front-end circuit are integrated on each transducer array element through a CMOS large-scale manufacturing process; the transmitting analog front-end circuit is used for generating ultrasonic waves; the receiving analog front-end circuit is used for converting the ultrasonic echo signals into electric signals.

Compared with the prior art, the ultrasonic device provided by the application adopts a plurality of transducer array elements which are arranged in a rectangular array, the distance between the transducer array elements is not more than the wavelength corresponding to the target ultrasonic working frequency, and the smaller the distance between the transducer array elements is, the side lobe energy in an ultrasonic sound field can be effectively reduced, so that the main lobe energy is enhanced, and further, the ultrasonic echo electric signal obtains a better signal-to-noise ratio; by integrating the transmitting analog front-end circuit and the receiving analog front-end circuit, ultrasonic wave transmitting and echo receiving of a plurality of transducer array elements can be automatically completed, parasitic capacitance and link loss are reduced, and the signal-to-noise ratio, the signal processing efficiency and the image resolution of imaging electric signals are improved.

In one embodiment of the present application, referring to fig. 1, the ultrasonic device further includes a logic control module and an analog-to-digital conversion circuit module, which are used for three-dimensional ultrasonic scanning and outputting a real-time three-dimensional ultrasonic imaging electrical signal. The transmitting analog front-end circuit comprises a driver circuit and a direct current bias voltage line; the direct current bias voltage circuit is used for enabling the energy converter unit to be in a pull-in working mode; the driver circuit transmits an alternating current excitation signal to the transducer unit, so that the vibrating diaphragm in the transducer unit vibrates to generate ultrasonic waves. The DC bias voltage in the DC bias voltage line does not exceed 150V. The receiving analog front-end circuit comprises a switch circuit and a trans-impedance amplifier circuit; the switch circuit opens or closes the receiving signal channel; the transimpedance amplifier circuit comprises a CSA charge-sensitive amplifier for converting a weak current signal generated by ultrasonic echo into a voltage signal,and low noise signal amplification is performed. In FIG. 1, V_TXRepresenting the low-voltage alternating current excitation signal output by the logic unit at the transmitting end; c_iRepresents a blocking capacitor; v_DC-biasRepresents a dc bias voltage; c_fA negative feedback capacitor representing the transimpedance amplifier; v_RXRepresenting the ultrasonic echo electrical signal output by the transimpedance amplifier.

In an embodiment of the present application, the transducer array includes four transducer units connected in parallel in sequence, the transducer units adopt a diaphragm structure, the whole diaphragm structure is square or in other geometric shapes (e.g., circular or elliptical, etc.), the transducer units include a top electrode, a bottom electrode and a vacuum cavity under the diaphragm, and a passive layer material (e.g., SiN material) is disposed above the top electrode; the top and bottom electrodes of each transducer element are electrically connected in a one-to-one correspondence. The vacuum cavity is manufactured on a silicon substrate through a dry etching process or a wet etching process, and is arranged to enable a vibrating diaphragm formed by a top electrode, a passive layer and the like to realize an ideal 'piston' effect, reduce the resistance borne by the vibrating diaphragm during vibration and further increase the electroacoustic conversion efficiency of the transducer.

The present application further provides an ultrasound imaging catheter, please refer to fig. 2 and fig. 3 together, the ultrasound imaging catheter includes a catheter body 1 and the above-mentioned ultrasound device, the ultrasound device is installed at the first end of the catheter body.

The utility model provides an ultrasonic imaging catheter, compared with the prior art, the ultrasonic imaging catheter that this application provided can provide real-time three-dimensional digital ultrasonic imaging signal of telecommunication, can generate three-dimensional ultrasonic image through direct digital signal processing, can promote the measurement of target organizational structure (such as oval hole, left auricle, mitral valve etc.) efficiency and the degree of accuracy in the heart chamber simultaneously by a wide margin, and to the occluder, the artificial valve, the positioning accuracy of implanting intervention apparatus such as ablation catheter and ventricle auxiliary device in the art, help the doctor to evaluate treatment more accurately.

In one embodiment of the present application, referring to fig. 2, the ultrasound imaging catheter further comprises an operating handle 3; an operating handle 3 is provided at the second end of the catheter body 1. The operating handle is provided with an identification module 5. The identification module 5 is provided with a Flash memory chip for storing product information such as the ID, the size and the specification of the conduit, and is electrically connected with the ultrasonic imaging equipment through a connector 8 to realize the read-write operation of the conduit information.

In one embodiment of the present application, referring to fig. 2, the catheter body 1 is a bendable catheter; a plurality of traction wires 4 are arranged in the catheter body 1; one end of the traction wire 4 is fixedly connected with the first end of the catheter body 1; the other end of the traction wire 4 is movably connected with the operating handle 3. The operating handle is provided with a knob 6, and the other end of the traction wire 4 is connected with the knob 6; the effective working length of the traction wire 4 is adjusted by rotating the knob 6, and when the effective working length of the traction wire 4 is smaller than the length of the catheter body, the second end of the catheter body is turned or bent under the action of the tensile force of the traction wire 4. The number of the traction wires 4 can be two or four or even more, and the more the number of the traction wires 4, the more precise the angle direction of the bending of the catheter body. The embodiment is not limited to the mode of adopting the knob 6, and the pull wire 4 can be directly pulled to achieve the purpose of bending the catheter body. By adopting the bendable conduit, the ultrasonic device 2 is not limited by the imaging window, the spatial position and the imaging angle can be flexibly and conveniently adjusted, the operation is more convenient, the target tissue can be measured in all directions, and the operation time is effectively reduced.

In an embodiment of the present application, please refer to fig. 2, the ultrasound imaging catheter further includes a transmission wire 7, the transmission wire 7 is disposed along the inner cavity of the catheter body 1, one end of the transmission wire 7 is connected to the ultrasound device 2, and the other end of the transmission wire 7 is used for externally connecting an ultrasound imaging apparatus. The transmission wire 7 may be a coaxial cable or an FPC (flexible circuit board).

The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.