CN116019492A - Magnetic control interventional ultrasonic imaging catheter and system - Google Patents

Abstract

The invention discloses a magnetic control interventional ultrasonic imaging catheter, which belongs to the field of medical equipment, wherein a flexible joint is connected with an imaging unit, a magnetic response module of the imaging unit is arranged in a shell and can rotate circumferentially relative to the shell, a reflecting mirror is fixedly connected with the magnetic response module, an axial positioning piece is fixed on the shell, the axial positioning piece is matched with the magnetic response module or/and the reflecting mirror to axially position the magnetic response module in the shell, a transducer is fixedly arranged on the shell and is opposite to the reflecting mirror, the magnetic response module drives the reflecting mirror to rotate relative to the transducer and drive the flexible joint to deform under the action of an external magnetic field, and through the design, the mode of using a non-contact magnetic drive to replace a traditional end motor to drive a flexible shaft can be used for simultaneously improving the operability in the catheter insertion process and the stability in the imaging process. The invention also relates to a magnetic control interventional ultrasonic imaging system comprising the magnetic control interventional ultrasonic imaging catheter.

Description

Magnetically controlled interventional ultrasound imaging catheter and system

technical field

The invention relates to the field of medical devices, in particular to a magnetically controlled interventional ultrasonic imaging catheter.

Background technique

Interventional ultrasound refers to the technology of sending a micro-ultrasound probe into the diseased part of the human body through the natural orifice of the human body or a small wound for diagnosis and treatment. Intravascular Ultrasound (IVUS) is a typical representative of interventional ultrasound. Its working principle is to install a miniature ultrasonic transducer on the tip of the catheter, send the ultrasonic catheter to the target area through the guide wire, and transmit and receive during the withdrawal process. High-frequency ultrasound signals are used for imaging. IVUS can accurately describe the three-dimensional anatomical structure of blood vessels in real time, observe the degree of lumen stenosis, and detect atherosclerotic plaques, greatly improving the accuracy of diagnosis, and has important guiding significance for treatment strategies, stent selection, and effect evaluation.

There are two main types of ultrasonic catheters: mechanical rotary and phased array. Among them, the mechanical rotating ultrasonic catheter uses a metal steel wire of about 1.5 meters as a flexible shaft, and the motor drives the flexible shaft at the end of the body to drive the single-array element transducer at the other end to rotate 360°. Shaft exterior prevents vessel abrasion. However, the existing ultrasonic catheters still face challenges in the use of highly narrow and curved vascular regions: the structure and material properties of the flexible shaft limit the overall stiffness of the ultrasonic catheter and reduce the handling performance; the ultrasonic inner core and the external catheter need to be used together, which limits the overall Size: There is friction between the transmission shaft and the inner wall of the catheter, which will cause the head ultrasonic transducer to fail to rotate at a uniform speed and cause non-uniform rotation artifacts (Non-uniform Distribution, NURD).

Therefore, it is an urgent problem for those skilled in the art to develop an interventional imaging catheter that can be used in highly narrow and curved areas.

Contents of the invention

In order to overcome the deficiencies of the prior art, one of the objectives of the present invention is to provide a magnetically controlled interventional ultrasound imaging catheter, which uses non-contact magnetic drive instead of the traditional terminal motor to drive the soft shaft, and can simultaneously improve the control during catheter insertion stability and stability during imaging.

One of purpose of the present invention adopts following technical scheme to realize:

A magnetically controlled interventional ultrasonic imaging catheter, comprising an imaging unit and a flexible joint connected to the imaging unit, the imaging unit comprising a housing, a magnetic response module, a mirror, an axial positioning member and a transducer , the magnetic response module is installed inside the housing and can rotate circumferentially relative to the housing, the mirror is fixedly connected to the magnetic response module, the axial positioning member is fixed to the housing, and the shaft The positioning member cooperates with the magnetic response module or/and the reflector to axially position the magnetic response module in the housing, the transducer is fixedly mounted on the housing and faces the reflector, Under the action of an external magnetic field, the magnetic response module drives the mirror to rotate relative to the transducer and drives the flexible joint to deform.

Further, the imaging unit further includes a fixing frame, the transducer is mounted on the fixing frame, the fixing frame is fixed on the casing, and the transducer is fixed on the casing through the fixing frame.

Further, the imaging unit further includes a connecting piece, and the two ends of the connecting piece are fixedly connected to the mirror and the magnetic response module respectively.

Further, the axial positioning member is a magnetic ball shaft, the magnetic ball shaft is fixed to the housing, and the magnetic response module is adsorbed to the magnetic ball shaft.

Further, the axial positioning member is a positioning ring, and the number of the positioning rings is two, and the two positioning rings are respectively installed at both ends of the magnetic response module to limit the axial movement of the magnetic response module.

Further, the transducer is fixed on one end of the casing away from the flexible joint, and the magnetic response module is installed on the other end of the casing close to the flexible joint.

Further, the transducer is fixed on one end of the casing close to the flexible joint, and the magnetic response module is installed on the other end of the casing away from the flexible joint.

Further, the magnetically controlled interventional ultrasonic imaging catheter also includes a coaxial cable and a terminal catheter, the two ends of the flexible joint are respectively connected to the imaging unit and the terminal catheter, and the coaxial cable is embedded in the flexible joint. between the joint and the end catheter.

Further, the imaging unit further includes a sealing ring, the housing is filled with acoustic coupling liquid, and the sealing ring is installed at the end of the housing away from the flexible joint, and the sealing ring prevents leakage of the housing.

A magnetically controlled interventional ultrasound imaging system, comprising the above-mentioned magnetically controlled interventional ultrasound imaging catheter, the magnetically controlled interventional ultrasound imaging system also includes a magnetic drive device, the magnetic drive device can generate an external magnetic field, the external magnetic field The direction can be changed, and the external magnetic field acts on the magnetic response module, so that the magnetic response module drives the mirror to rotate relative to the transducer under the action of the external magnetic field and drives the flexible joint to deform.

Compared with the prior art, the magnetic response module of the magnetically controlled interventional ultrasonic imaging catheter of the present invention is installed inside the housing and can rotate circumferentially relative to the housing, the mirror is fixedly connected to the magnetic response module, the axial positioning member is fixed on the housing, and the The positioning part cooperates with the magnetic response module or/and the reflector to position the magnetic response module axially in the casing, the transducer is fixedly installed in the casing and faces the reflector, and the magnetic response module drives the reflector to perform relative energy conversion under the action of an external magnetic field The device rotates and drives the flexible joint to deform. Through the above design, the non-contact magnetic drive is used instead of the traditional terminal motor to drive the flexible shaft, which can simultaneously improve the maneuverability during catheterization and the stability during imaging.

Description of drawings

Fig. 1 is a schematic structural view of the first embodiment of the magnetically controlled interventional ultrasonic imaging catheter of the present invention;

FIG. 2 is a schematic structural diagram of an imaging unit of the magnetically controlled interventional ultrasound imaging catheter of FIG. 1;

FIG. 3 is a schematic diagram of the magnetically controlled interventional ultrasound imaging catheter in FIG. 1 in a navigation mode;

FIG. 4 is a schematic diagram of the magnetically controlled interventional ultrasound imaging catheter in FIG. 1 in an imaging mode;

5 is a schematic structural view of a second embodiment of the magnetically controlled interventional ultrasonic imaging catheter of the present invention;

6 is a schematic structural diagram of a third embodiment of the magnetically controlled interventional ultrasonic imaging catheter of the present invention;

FIG. 7 is a schematic structural view of a fourth embodiment of the magnetically controlled interventional ultrasonic imaging catheter of the present invention.

In the figure: 100, imaging unit; 101, shell; 102, magnetic response module; 103, connector; 104, mirror; 105, transducer; 106, fixing frame; 107, sealing ring; 108, acoustic coupling liquid; 109, magnetic ball shaft; 110, positioning ring; 200, flexible joint; 300, coaxial cable; 400, terminal catheter; 500, external magnetic field.

Detailed ways

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.

It should be noted that when a component is said to be “fixed” to another component, it may be directly on the other component or there may be another intermediate component through which it is fixed. When a component is said to be "connected" to another component, it may be directly connected to the other component or there may be another intermediate component at the same time. When a component is said to be "set on" another component, it may be set directly on the other component or there may be another intermediate component at the same time. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for purposes of illustration only.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

As shown in FIG. 1 to FIG. 4 , it is the first embodiment of the magnetically controlled interventional ultrasonic imaging catheter of the present invention, which includes an imaging unit 100 , a flexible joint 200 , a coaxial cable 300 and a terminal catheter 400 .

The imaging unit 100 includes a housing 101 , a magnetic response module 102 , a connecting piece 103 , a mirror 104 , a transducer 105 , a fixing frame 106 , a sealing ring 107 and an axial positioning piece.

The shell 101 is the outermost structure of the imaging unit 100, which fixes, constrains or protects other components, and serves as a sound-transmitting window for the sound field. Specifically, the housing 101 is a hollow cylindrical structure. The magnetic response module 102 , the connecting piece 103 , the mirror 104 , the transducer 105 , the fixing frame 106 , the sealing ring 107 and the axial positioning piece are installed inside the casing 101 .

The magnetic response module 102 can respond to an external magnetic field, and drive the mirror 104 to rotate or the flexible joint 200 to bend under the action of magnetic force and magnetic moment. Specifically, the magnetic response module 102 is cylindrical.

The connecting piece 103 is used to fix the magnetic response module 102 and the mirror 104 . One end of the connector 103 is fixedly connected to the magnetic response module 102 , and the other end is fixedly connected to the reflector 104 , so that the magnetic response module 102 is fixedly connected to the reflector 104 , so that the magnetic response module 102 drives the reflector 104 to rotate.

The reflector 104 is used for sound field reflection, and converts the axially emitted ultrasound into a 360° rotating radial ultrasound to realize side-view imaging. The reflective surface of the mirror 104 is opposite to the transducer 105 .

The transducer 105 can send and receive ultrasonic signals within a certain frequency range, and generate ultrasonic images after post-processing.

The fixing frame 106 is used for installing the transducer 105 and is fixed to the casing 101 so that the transducer 105 is fixed to the casing 101 .

The sealing ring 107 provides a sealed environment for the imaging unit.

The acoustic coupling liquid 108 enables the emitted sound waves to be smoothly transmitted into the human body and the reflected sound waves to be smoothly transmitted and captured by the transducer, and at the same time play a lubricating role.

The axial positioning member is used to restrict the axial movement of the magnetic response module 102 , so that the axial positioning of the magnetic response module 102 is limited in the casing 101 . Specifically, the axial positioning member is the magnetic ball shaft 109 in this embodiment, and the position of the magnetic ball shaft 109 and the reflector 104 is limited by magnetic attraction, and the spherical surface provides a fulcrum for rotation.

The flexible joint 200 is fixed at the end of the imaging unit 100, and the flexible joint 200 deforms as the position of the imaging unit 100 changes, so as to facilitate the ultrasonic diagnosis and treatment of the imaging unit 100 in highly narrow and tortuous areas.

The terminal catheter 400 is fixed on the flexible joint 200 , and the coaxial cable 300 is embedded in the flexible joint 200 and the terminal catheter 400 to provide power to the imaging unit 100 . The terminal catheter 400 is connected with the extracorporeal catheter feeding device to realize the retraction movement of the magnetically controlled interventional ultrasound imaging catheter.

When assembling the magnetic control interventional ultrasound imaging catheter, the magnetic response module 102 , the connecting piece 103 , the mirror 104 , the transducer 105 , the fixing frame 106 , the sealing ring 107 and the axial positioning piece are installed inside the housing 101 . The transducer 105 is fixed on the end of the housing 101 away from the flexible joint 200 through the fixing frame 106 , and the magnetic ball shaft 109 is fixed on the end of the housing 101 close to the flexible joint 200 . The sealing ring 107 is installed between the magnetic ball shaft 109 and the housing 101 to achieve sealing. One end of the connector 103 is fixedly connected to the magnetic response module 102 , and the other end is fixedly connected to the reflector 104 . The magnetic response module 102 is adsorbed to the magnetic ball shaft 109 to prevent axial movement of the magnetic response module 102 and the mirror 104 . The inner diameter of the housing 101 is slightly larger than the outer diameter of the magnetic response module 102 , which acts as a bushing and ensures the circumferential positioning of the magnetic response module 102 and the mirror 104 . The flexible joint 200 is fixed at the end of the imaging unit 100 , the terminal catheter 400 is fixed on the flexible joint 200 , and the flexible joint 200 is located between the imaging unit 100 and the terminal catheter 400 . The terminal catheter 400 is connected with the extracorporeal catheter feeding device to realize the retraction movement of the magnetically controlled interventional ultrasound imaging catheter.

When the magnetically controlled interventional ultrasound imaging catheter is used, in the navigation mode, the forward and backward movement of the magnetically driven interventional ultrasound imaging catheter is provided by an extracorporeal catheter feeding device, and the steering movement is driven by an external magnetic field. The control process is as follows. Firstly, an external magnetic field 500 perpendicular to the central axis of the imaging unit 100 is applied. At this time, the magnetic response module 102 rotates inside the casing 101 without changing the overall shape of the catheter, and adjusts the N pole and S pole to the desired deformation plane. superior. Next, change the direction of the external magnetic field 500 in the desired deformation plane. At this time, the movement of the magnetic response module 102 is restricted by the shell 101, which drives the flexible joint 200 of the catheter to deform until the applied magnetic moment and the internal stress of the catheter are dynamically balanced. . In the prior art, the traditional passive mechanical rotary ultrasound catheter has relatively high overall stiffness and does not have the ability to actively deform. During the operation, the doctor controls the movement of the guide wire head by pushing, pulling and twisting the end of the body, and uses the vessel wall to slide into the target branch. This method of operation has high requirements on the doctor's experience, and at the same time has the risk of vascular perforation. The magnetically driven interventional ultrasonic imaging catheter of the present application has high overall flexibility, and can be actively deformed under the action of the external magnetic field 500 to automatically enter the target branch.

In the imaging mode, the retraction movement of the magnetically driven interventional ultrasound imaging catheter is provided by an extracorporeal catheter feeding device, and the rotational movement of the probe is driven by an external magnetic field 500 . The control process is as follows, an external magnetic field 500 perpendicular to the central axis of the imaging unit 100 is applied to drive the mirror 104 to rotate by 360°. In particular, the applied field in this mode is a rotating field. In one period, the magnetic field vector forms a plane in a direction perpendicular to the central axis of the imaging unit 100, such as a perfect circle (the magnetic field strength is constant) or an ellipse (the magnetic field strength is periodic Change). The external magnetic field 500 controls and drives the mirror 104 to rotate at a constant speed. The ultrasonic signal encounters a reflective surface and changes its path, stabilizing the imaging. In the prior art, the traditional passive mechanical rotary ultrasound catheter uses a metal wire as the flexible shaft. During the imaging process, there is friction between the transmission shaft and the inner wall of the catheter, causing uneven rotation artifacts, which will be exacerbated by highly narrow and curved blood vessels. The transducer 105 of the magnetically driven interventional ultrasonic imaging catheter of the present application does not need to be rotated by a flexible shaft, and the imaging performance is not affected by the structural deformation of the rear end catheter, and can be used for imaging in complex environments with twists and turns.

Please continue to refer to Fig. 5, which is the second embodiment of the magnetically controlled interventional ultrasound imaging catheter of the present invention. In the second embodiment, the structure of the magnetically controlled interventional ultrasonic imaging catheter is roughly the same as that of the first embodiment, except that: The transducer 105 is fixed to the end of the casing 101 close to the flexible joint 200 through the fixing frame 106 , and the magnetic ball shaft 109 is fixed to the end of the casing 101 away from the flexible joint 200 . The sealing ring 107 is installed between the magnetic ball shaft 109 and the housing 101 to achieve sealing.

Please continue to refer to Fig. 6, which is the third embodiment of the magnetically controlled interventional ultrasound imaging catheter of the present invention. In the third embodiment, the structure of the magnetically controlled interventional ultrasonic imaging catheter is roughly the same as that of the first embodiment, except that: The axial positioning member is a positioning ring 110, and the number of positioning rings 110 is two. The two positioning rings 110 are respectively installed on both ends of the magnetic response module 102 to limit the axial movement of the magnetic response module 102 and the reflector 104, preventing the magnetic response module 102 from And the axial movement of the mirror 104. The two positioning rings 110 are mounted on one end of the casing 101 close to the flexible joint 200 .

Please continue to refer to FIG. 7, which is the fourth embodiment of the magnetically controlled interventional ultrasound imaging catheter of the present invention. In the fourth embodiment, the structure of the magnetically controlled interventional ultrasound imaging catheter is roughly the same as that of the third embodiment, except that: The transducer 105 is fixed on the end of the housing 101 close to the flexible joint 200 through the fixing frame 106 , and the two positioning rings 110 are installed on the end of the housing 101 away from the flexible joint 200 . The sealing ring 107 is installed between the positioning ring 110 and the housing 101 to achieve sealing.

The magnetic drive interventional ultrasonic imaging catheter of this application is used for ultrasonic diagnosis and treatment in highly narrow and tortuous areas. Under the action of the external magnetic field 500, the catheter can perform multiple working modes. In the navigation mode, the catheter head (imaging unit 100) can actively turn to enter the target branch, reducing the risk of vascular wall abrasion and perforation; Ultrasound image. The magnetic-driven interventional ultrasound imaging catheter is suitable for multiple tissues and organs in the body, such as blood vessels, lungs, and digestive tract.

The present application also relates to a magnetic-drive interventional ultrasound imaging system comprising the above-mentioned magnetic-drive interventional ultrasound imaging catheter and an external magnetic field 500 .

The above examples only express several implementation modes of the present invention, and the description thereof is relatively specific and detailed, but it should not be construed as limiting the scope of the patent for the invention. It should be pointed out that for those skilled in the art, without departing from the concept of the present invention, several modifications and improvements can be made, all of which are equivalent modifications made to the above embodiments based on the substantive technology of the present invention and evolution, these all belong to the protection scope of the present invention.

Claims (10)

1. A magnetically controlled interventional ultrasonic imaging catheter, comprising an imaging unit and a flexible joint, characterized in that: the flexible joint is connected to the imaging unit, and the imaging unit includes a shell, a magnetic response module, a mirror, an axial A positioning member and a transducer, the magnetic response module is installed inside the housing and can rotate circumferentially relative to the housing, the mirror is fixedly connected to the magnetic response module, and the axial positioning member is fixed to the The housing, the axial positioning member cooperates with the magnetic response module or/and the reflector to axially position the magnetic response module in the housing, and the transducer is fixedly installed on the housing and connected to the The reflector is facing directly, and the magnetic response module drives the reflector to rotate relative to the transducer under the action of an external magnetic field and drives the flexible joint to deform. 2. The magnetically controlled interventional ultrasonic imaging catheter according to claim 1, characterized in that: the imaging unit further comprises a fixing frame, the transducer is mounted on the fixing frame, and the fixing frame is fixed on the The housing, the transducer is fixed to the housing through the fixing frame. 3. The magnetically controlled interventional ultrasonic imaging catheter according to claim 1, characterized in that: the imaging unit further includes a connector, and the two ends of the connector are respectively fixedly connected to the mirror and the magnetic response module . 4. The magnetically controlled interventional ultrasonic imaging catheter according to claim 1, characterized in that: the axial positioning member is a magnetic ball shaft, the magnetic ball shaft is fixed on the housing, and the magnetic response module is connected to the The above-mentioned magnetic ball shaft adsorption. 5. The magnetically controlled interventional ultrasonic imaging catheter according to claim 1, characterized in that: the axial positioning member is a positioning ring, the number of the positioning rings is two, and the two positioning rings are respectively installed on the The two ends of the magnetic response module limit the axial movement of the magnetic response module. 6. The magnetically controlled interventional ultrasonic imaging catheter according to any one of claims 1, wherein the transducer is fixed on the end of the shell away from the flexible joint, and the magnetic response module is installed on the The housing is adjacent to the other end of the flexible joint. 7. The magnetically controlled interventional ultrasonic imaging catheter according to any one of claims 1, characterized in that: the transducer is fixed on the end of the housing close to the flexible joint, and the magnetic response module is installed on the The other end of the housing away from the flexible joint. 8. The magnetically controlled interventional ultrasonic imaging catheter according to any one of claims 1, characterized in that: the magnetically controlled interventional ultrasonic imaging catheter also includes a coaxial cable and a terminal catheter, and the two ends of the flexible joint are respectively connected to The imaging unit is connected to the end catheter, and the coaxial cable is buried between the flexible joint and the end catheter. 9. The magnetically controlled interventional ultrasonic imaging catheter according to any one of claims 1, characterized in that: the imaging unit further includes a sealing ring, the shell is filled with acoustic coupling liquid, and the shell is far away from the flexible joint The sealing ring is installed at the end of the sealing ring, and the sealing ring prevents the leakage of the casing. 10. A magnetic control interventional ultrasound imaging system, characterized in that: it comprises the magnetic control interventional ultrasound imaging catheter according to any one of claims 1-9, and the magnetic control interventional ultrasound imaging system also includes a magnetic drive device, the magnetic drive device can generate an external magnetic field, the direction of the external magnetic field can be changed, and the external magnetic field acts on the magnetic response module, so that the magnetic response module drives the reflector relative to the external magnetic field The transducer rotates and drives the flexible joint to deform.

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