阅读说明：本技术 一种心腔内二维超声成像导管及其系统 (Two-dimensional ultrasonic imaging catheter in cardiac chamber and system thereof ) 是由 刘斌 于 2021-07-15 设计创作，主要内容包括：本申请提供了一种心腔内二维超声成像导管,包括导管本体和设置在导管本体一端的超声波器件；超声波器件包括多个呈线状阵列排布的换能器单元,换能器单元采用振膜结构,振膜的直径或长度不超过目标超声波工作频率对应波长的二分之一。本申请还提供了一种心腔内二维超声成像导管系统,包括具备超声脉冲波多普勒、连续波多普勒和彩色多普勒功能的超声成像主机和心腔内二维超声成像导管；超声成像主机用于生成二维超声图像。本申请与传统TEE食道超声技术相比,能显著降低术中的X射线剂量和术中造影剂的应用,避免了插管的不适感；超声波探头不受气体介质影响,声能衰减小,提升了检测深度和图像分辨率；能够实时进行术中心包检测,提高了手术安全性。(The application provides a two-dimensional ultrasonic imaging catheter in a heart cavity, which comprises a catheter body and an ultrasonic device arranged at one end of the catheter body; the ultrasonic device comprises a plurality of transducer units which are arranged in a linear array, the transducer units adopt a vibrating diaphragm structure, and the diameter or the length of the vibrating diaphragm does not exceed one half of the corresponding wavelength of the target ultrasonic working frequency. The application also provides a two-dimensional ultrasonic imaging catheter system in the heart cavity, which comprises an ultrasonic imaging host machine with the functions of ultrasonic pulse wave Doppler, continuous wave Doppler and color Doppler and a two-dimensional ultrasonic imaging catheter in the heart cavity; the ultrasonic imaging host is used for generating a two-dimensional ultrasonic image. Compared with the traditional TEE esophagus ultrasonic technology, the application can obviously reduce the X-ray dosage in operation and the application of contrast agent in operation, and avoids the discomfort of intubation; the ultrasonic probe is not influenced by gas media, so that the acoustic energy attenuation is reduced, and the detection depth and the image resolution are improved; the pericardium detection in the operation can be carried out in real time, and the operation safety is improved.)

1. A two-dimensional ultrasonic imaging catheter in a cardiac chamber is characterized by comprising a catheter body (1) and an ultrasonic device (2); the ultrasonic device (2) is arranged at the first end of the catheter body (1);

the ultrasonic device (2) comprises a plurality of transducer units which are arranged in a linear array; the transducer unit adopts a diaphragm structure, and the diameter or the length of the diaphragm does not exceed one half of the wavelength corresponding to the target ultrasonic working frequency.

2. The intracardiac two-dimensional ultrasound imaging catheter according to claim 1, wherein: the ultrasonic device (2) is prepared on a silicon substrate by adopting a PMUT manufacturing process or a CMUT manufacturing process.

3. The intracardiac two-dimensional ultrasound imaging catheter according to claim 1, wherein: two adjacent columns of transducer units form a transducer element, and the number of the transducer elements is not more than 100.

4. The intracardiac two-dimensional ultrasound imaging catheter according to claim 1, wherein: the transducer array comprises two rows of transducer units which are connected in parallel in sequence; the transducer unit comprises a top electrode, a bottom electrode and a vacuum cavity below the vibrating diaphragm, wherein a passive layer material is arranged above the top electrode.

5. The intracardiac two-dimensional ultrasound imaging catheter according to any of claims 1 to 4, wherein: also comprises an operating handle (3); the operating handle (3) is arranged at the second end of the catheter body (1).

6. The intracardiac two-dimensional ultrasound imaging catheter according to claim 5, 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).

7. An intracardiac two-dimensional ultrasonic imaging catheter system, which is characterized by comprising an ultrasonic imaging host with the functions of ultrasonic pulse wave Doppler, continuous wave Doppler and color Doppler and the intracardiac two-dimensional ultrasonic imaging catheter as claimed in any one of claims 1 to 6; the ultrasonic imaging host is connected with the ultrasonic device (2) and used for generating a two-dimensional ultrasonic image.

8. The intracardiac two-dimensional ultrasound imaging catheter system of claim 7, wherein: the intracardiac two-dimensional ultrasound imaging catheter further comprises an identification module (5); the identification module (5) is electrically connected with the ultrasonic imaging host.

9. The intracardiac two-dimensional ultrasound imaging catheter system of claim 7, wherein: the intracardiac two-dimensional ultrasonic imaging pipe still includes transmission wire (7), transmission wire (7) are followed the inside cavity of pipe body (1) arranges, transmission wire (7) one end with the ultrasonic imaging host computer is connected, transmission wire (7) the other end with ultrasonic device (2) are connected.

10. The intracardiac two-dimensional ultrasound imaging catheter system of claim 8, wherein: the identification module (5) is configured with a Flash memory chip.

Technical Field

The application belongs to the technical field of structural heart disease treatment equipment, and particularly relates to a two-dimensional ultrasonic imaging catheter in a heart cavity and a system thereof.

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 is used for detecting a far field, the resolution is reduced due to the attenuation of sound energy, so that the display of structures such as a right ventricle and a pulmonary valve is poor.

Disclosure of Invention

An object of the embodiment of the application is to provide a cardiac chamber two-dimensional ultrasonic imaging catheter and a system thereof, so as to solve the technical problems of intubation discomfort, low operation safety, poor ultrasonic imaging quality and the like existing in the TEE esophageal ultrasonic technology in the structural heart disease treatment operation process.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: the two-dimensional ultrasonic imaging catheter in the heart cavity comprises a catheter body and an ultrasonic device; the ultrasonic device is arranged at the first end of the catheter body;

the ultrasonic device comprises a plurality of transducer units which are arranged in a linear array; the transducer unit adopts a diaphragm structure, and the diameter or the length of the diaphragm does not exceed one half of the wavelength corresponding to the target ultrasonic working frequency.

Optionally, the ultrasonic device is fabricated on a silicon substrate using a PMUT or CMUT fabrication process.

Optionally, two adjacent columns of transducer elements constitute one transducer element, and the number of the transducer elements is not more than 100.

Optionally, the transducer unit comprises two columns of transducer units connected in parallel in sequence; the transducer unit comprises a top electrode, a bottom electrode and a vacuum cavity below the vibrating diaphragm, wherein a passive layer material is arranged above the top electrode.

Optionally, the intracardiac two-dimensional 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.

The application also provides a two-dimensional ultrasonic imaging catheter system in the heart chamber, which comprises an ultrasonic imaging host machine with the functions of ultrasonic pulse wave Doppler, continuous wave Doppler and color Doppler and a two-dimensional ultrasonic imaging catheter in the heart chamber; the ultrasonic imaging host is connected with the ultrasonic device and used for generating a two-dimensional ultrasonic image.

Optionally, the intracardiac two-dimensional ultrasound imaging catheter further comprises an identification module; the identification module is electrically connected with the ultrasonic imaging host.

Optionally, the two-dimensional ultrasound imaging catheter in the cardiac chamber further includes a transmission lead, the transmission lead is arranged along the inner cavity of the catheter body, one end of the transmission lead is connected with the ultrasound imaging host, and the other end of the transmission lead is connected with the ultrasound device.

Optionally, the identification module is configured with a Flash memory chip.

The application provides a two-dimentional ultrasonic imaging pipe in heart chamber's beneficial effect lies in: compared with the prior art, the two-dimensional ultrasonic imaging catheter in the heart cavity provided by the application has the advantages that the transducer unit in the ultrasonic device adopts the structure, the diameter or the length of the vibrating diaphragm does not exceed one half of the corresponding wavelength of the target ultrasonic working frequency, the smaller the size of the vibrating diaphragm is, the distance between transducer units can be effectively reduced, the side lobe energy in an ultrasonic sound field can be effectively reduced, the energy of a main lobe is enhanced, and the ultrasonic echo electric signal obtains a better signal-to-noise ratio.

In the alternative, the ultrasonic device is prepared on the silicon substrate by adopting a PMUT (passive acoustic transducer) manufacturing process or a CMUT (capacitive micro-machined groove) manufacturing process, so that the integration level of the ultrasonic device is improved, the consistency of transducer units is good, a simulated ultrasonic imaging electric signal with a higher signal-to-noise ratio can be obtained, and the imaging quality of a two-dimensional ultrasonic image is improved.

The application provides a two-dimentional ultrasonic imaging catheter system in heart chamber's beneficial effect lies in: compared with the prior art, the application is different from the traditional TEE esophagus ultrasound, the X-ray dosage in the operation can be obviously reduced by applying the intracardiac ultrasound imaging technology, and the damage of the X-ray to the human body is reduced; the application of contrast medium in operation can be reduced, which is beneficial to protecting the kidney function of the patient; the ultrasonic imaging catheter in the heart cavity can be conveyed into the heart cavity through femoral vein puncture, general anesthesia is not needed, and discomfort of intubation is avoided; the ultrasonic probe is not influenced by gas media, so that the acoustic energy attenuation is reduced, and the detection depth and the image resolution are improved; the pericardium detection in the operation can be carried out in real time, and the operation safety is favorably improved. The ultrasonic imaging catheter in the heart cavity can provide ultrasonic two-dimensional structural images of a heart, such as a fossa ovalis, a left atrium, a right atrium, a ventricle, a right auricle, a left auricle, an aortic valve, a mitral valve and a tricuspid valve, is used for preoperative assessment and operation scheme formulation, can also be used for guiding and positioning implantation interventional devices such as a plugging device, a prosthetic valve, an ablation catheter and a ventricular assist device in operation, and can be used for postoperative treatment effect assessment on operations such as foramen ovale plugging, left auricle plugging, valve repair or replacement by utilizing the ultrasonic pulse wave, continuous wave Doppler and color Doppler functions of an ultrasonic imaging host machine.

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 a two-dimensional ultrasound imaging catheter in a cardiac chamber according to an embodiment of the present application;

FIG. 2 is a schematic structural diagram of a two-dimensional intracardiac ultrasound imaging catheter system according to an embodiment of the present application;

fig. 3 is a partially enlarged schematic view of a in fig. 1.

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. 1-3 together, a two-dimensional intracardiac ultrasound imaging catheter and a system thereof according to an embodiment of the present application will now be described. The intracardiac two-dimentional ultrasonic imaging conduit, including body 1 of the conduit and ultrasonic device 2; the ultrasonic device 2 is arranged at the first end of the catheter body 1; the ultrasonic device 2 is a micro-electromechanical ultrasonic planar array chip; the micro-electromechanical ultrasonic planar array chip comprises N transducer array elements which are linearly arranged, wherein N is not more than 100. The transducer unit adopts a diaphragm structure, and the diaphragm is square or in other geometrical shapes, such as: circular or oval, etc., and the diameter or length of the diaphragm is not more than one half of the wavelength corresponding to the target ultrasonic working frequency.

The application provides a heart intracavity two-dimensional ultrasonic imaging pipe, compare with prior art, transducer unit in ultrasonic device 2 adopts the structure, and vibrating diaphragm diameter or length do not exceed the half of target ultrasonic working frequency corresponding wavelength, and the vibrating diaphragm size can effectively reduce the interval between the transducer unit more, thereby can effectively reduce the sidelobe energy in the ultrasonic sound field, makes the mainlobe energy reinforcing, and then makes the ultrasonic echo signal of telecommunication obtain better SNR.

In one embodiment of the present application, the ultrasonic device 2 is a micro-electromechanical ultrasonic planar array chip, which is fabricated on a silicon substrate using a PMUT (piezoelectric micromachined ultrasonic transducer) fabrication process or a CMUT (capacitive micromachined ultrasonic transducer) fabrication process. The micro-electro-mechanical ultrasonic planar array chip is adopted to replace a traditional piezoelectric ceramic ultrasonic device as an ultrasonic device, so that the processing technology is simple, the integration level is high, the manufacturing cost is low, the structure of the ultrasonic device is simplified, the signal-to-noise ratio of an ultrasonic imaging electric signal obtained by the ultrasonic device is improved, and the quality of a two-dimensional ultrasonic image in a heart cavity is improved.

In one embodiment of the present application, the transducer unit includes two rows of transducer units connected in parallel in sequence, 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) is disposed above the top electrode. 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 increase the electroacoustic conversion efficiency of the transducer.

An embodiment of the present application further provides a two-dimensional ultrasound imaging catheter system in a cardiac chamber, including a two-dimensional ultrasound imaging catheter in a cardiac chamber and an ultrasound imaging host, please refer to fig. 2.

The ultrasonic imaging host is connected with the ultrasonic device through a connector 8 and a transmission lead 7 and is used for acquiring imaging electric signals output by the ultrasonic imaging catheter in the heart cavity, and generating a two-dimensional ultrasonic image after signal processing and image processing; a transmission conductor 7, which may be a coaxial cable or an FPC (flexible circuit board), is arranged along the inner cavity of the catheter body 1.

Compared with the prior art, the intracardiac two-dimensional ultrasonic imaging catheter system is different from the traditional TEE esophagus ultrasonic, the X-ray dosage in the operation can be obviously reduced by applying the intracardiac ultrasonic imaging technology, and the injury of the X-ray to the human body is reduced; the application of contrast medium in operation can be reduced, which is beneficial to protecting the kidney function of the patient; the ultrasonic imaging catheter in the heart cavity can be conveyed into the heart cavity through the femoral vein, general anesthesia is not needed, and discomfort of intubation is avoided; the ultrasonic probe is not influenced by gas media, so that the acoustic energy attenuation is reduced, and the detection depth and the image resolution are improved; the pericardium detection in the operation can be carried out in real time, and the operation safety is favorably improved. The ultrasonic imaging catheter in the heart cavity can provide ultrasonic two-dimensional structural images of a heart, such as a fossa ovalis, a left atrium, a right atrium, a ventricle, a right auricle, a left auricle, an aortic valve, a mitral valve and a tricuspid valve, is used for preoperative assessment and operation scheme formulation, can also be used for guiding and positioning implantation interventional devices such as a plugging device, a prosthetic valve, an ablation catheter and a ventricular assist device in operation, and can be used for postoperative treatment effect assessment on operations such as foramen ovale plugging, left auricle plugging, valve repair or replacement by utilizing the ultrasonic pulse wave, continuous wave Doppler and color Doppler functions of an ultrasonic imaging host machine.

The ultrasonic imaging host sends an electric excitation signal with time delay information to the ultrasonic device, drives each transducer array element in the ultrasonic device to sequentially transmit ultrasonic waves, converts ultrasonic wave echoes into analog imaging electric signals, and sends the analog imaging electric signals to the ultrasonic imaging host through an independent transmission wire 7 and a connector 8.

The ultrasonic imaging host generates a two-dimensional ultrasonic image in a heart cavity, and is used for measuring and evaluating structures of preoperative target tissues (such as a patent foramen ovale, atrial septal defect, aortic valve, left atrial appendage, mitral valve, tricuspid valve and the like), such as sizes of the patent foramen ovale and the atrial septal defect, the number and the shape of aortic valve leaflets, the size of left atrium, the existence of thrombus in the left atrial appendage, the size and the length of the entrance of the left atrial appendage, the volume of the left atrial appendage, the diameter of the mitral valve, the narrow caliber, the size of valve neoplasms or valve prolapse and the like, and can also be used for anchoring of an occluder, a prosthetic valve or other implantation instruments in operation, checking the shape and the functions of the occluder, the prosthetic valve or other implantation instruments after release, detecting and monitoring the pericardium in real time, and evaluating the contraction and relaxation functions of the heart after operation.

In an embodiment of the present application, the ultrasound imaging host has functions of ultrasound pulse wave, continuous wave doppler and color doppler, and is used for preoperatively examining blood flow conditions of target tissues (e.g., a foramen ovale, a ventricular septal defect, a left atrial appendage, a mitral valve, a tricuspid valve, etc.), such as blood flow velocities of an inflow tract and an outflow tract of the left atrium, shunting caused by a patent foramen ovale and an atrial septal defect, evaluating a degree of regurgitation caused by insufficiency of the mitral valve and the tricuspid valve, measuring a diameter and a blood flow velocity of LUPV, a maximal emptying and filling velocity of blood flow of the left atrial appendage, and the like, and also being capable of detecting whether a residual shunting exists after a release of an occluder, a prosthetic valve or other implantation apparatus, and whether residual regurgitation exists in the mitral valve and the tricuspid valve, and further evaluating a postoperative treatment effect.

In one embodiment of the present application, the intracardiac two-dimensional ultrasound imaging catheter further comprises an operation 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 host through the connector 8 to realize the read-write operation of the conduit information.

In one embodiment of the present application, 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.

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.