WO2021012638A1

WO2021012638A1 - Interventional therapy system and method

Info

Publication number: WO2021012638A1
Application number: PCT/CN2020/070465
Authority: WO
Inventors: 赵东生; 章东; 张冬宇; 王静; 缪莹莹
Original assignee: 江苏霆升科技有限公司
Priority date: 2019-07-25
Filing date: 2020-01-06
Publication date: 2021-01-28
Also published as: CN112274238A

Abstract

Disclosed is an interventional therapy system and method. The interventional therapy system comprises a catheter (4) and a holding member (9), which are connected to each other, wherein a mapping electrode (1) is embedded in the front end of the catheter (4), a balloon (3) is fitted on the catheter (4), a therapeutic transducer (5) and an imaging transducer (6) are sequentially arranged inside the catheter (4), the holding member (9) is internally provided with an electric motor (8), and the therapeutic transducer (5) and the imaging transducer (6) are both connected to the electric motor (8) and can be driven by the electric motor (8) to rotate. The interventional therapy system can perform destruction and electrical isolation on lesions at the pulmonary vein and outside the pulmonary vein.

Description

Interventional treatment system and method

This application claims the priority of a Chinese patent application filed with the Chinese Patent Office on July 25, 2019, the application number is 201910677233.8, and the application name is "an interventional therapy system and method", the entire content of which is incorporated into this application by reference .

Technical field

This application relates to the technical field of ablation therapy, and specifically to an interventional therapy system and method.

Background technique

Atrial fibrillation is currently the most common clinical arrhythmia disease. It not only induces cardiac insufficiency, but also increases the incidence of strokes in patients, thereby increasing the hospitalization rate and mortality of patients. Percutaneous catheter ablation has become the first-line treatment for atrial fibrillation. Studies have shown that the pulmonary vein is the source of lesions in more than 80% of atrial fibrillation, and some patients with atrial fibrillation (about 20%-30%) also have lesions outside the pulmonary vein. Pulmonary Vein Isolation (Pulmonary Vein Isolation, PVI) has become the basis of all atrial fibrillation catheter ablation strategies. At present, there are two mainstream methods for ablation of atrial fibrillation: thermal ablation (radiofrequency ablation) and cold ablation (cryoballoon). Thermal ablation (radio frequency ablation) refers to the real-time three-dimensional positioning of the radiofrequency ablation catheter under the three-dimensional mapping system, and the three-dimensional model of the heart is established through the catheter contacting the heart to draw a circle around the pulmonary veins for PVI and triggering of non-pulmonary veins through electrical mapping The focus is ablated. The advantage of this procedure is that it is reliable in isolation and can be ablated for non-pulmonary vein triggered foci. The disadvantage is that the equipment is expensive, the operation is complicated, and the learning curve is long. The frozen balloon enters the left atrium by puncturing the interatrial septum, implanting a flexible sheath, using a coordinated mapping catheter to deliver the frozen balloon to the pulmonary vein through a guide wire, and the balloon is inflated and positioned at each pulmonary vein opening. Contrast injection was used to confirm pulmonary vein obstruction, and on this basis, the balloon was cooled to isolate the pulmonary vein. The advantage of this procedure is that it is simple to operate, but the disadvantage is that it cannot ablate non-pulmonary vein triggered foci.

Application content

The purpose of this application is to provide an interventional treatment system and method that can electrically isolate the pulmonary vein and the lesion outside the pulmonary vein.

In order to achieve the above objective, the present application provides an interventional treatment system, the interventional treatment system includes a connected catheter and a holding member, wherein a mapping electrode is embedded in the front end of the catheter, and a balloon is installed on the catheter, A therapeutic transducer and an imaging transducer are arranged in the catheter in sequence, an electric motor is arranged in the holding member, and both the therapeutic transducer and the imaging transducer are connected to the electric motor , And can be driven to rotate by the electric motor.

Further, after the front end of the catheter is placed into the pulmonary vein, the balloon is inflated to fix the catheter.

Further, the therapeutic transducer and the imaging transducer are connected to the electric motor through a motor linkage guide wire.

Further, the front end of the catheter is embedded with two mapping electrodes at fixed intervals, and the two mapping electrodes are connected to the internal circuit through an electrode guide wire.

Further, the therapeutic transducer rotates under the drive of the electric motor, and electrically isolates the pulmonary vein from damage during the rotation, and the imaging transducer rotates under the drive of the electric motor, and obtains Two-dimensional images of the heart in different sections, and a three-dimensional model of the heart is constructed based on the obtained two-dimensional images of the heart.

Further, after the electrical isolation of the injury and the modeling of the three-dimensional model of the heart are completed, the gas in the balloon is drawn out, and the catheter is moved out to the triggering foci outside the pulmonary vein, so that the treatment transducer can be used for treatment. Single-point ablation of the triggering lesion is described.

Further, when performing single-point ablation of the triggering focus by the therapeutic transducer, the electric motor is turned off.

In order to achieve the above objective, the present application also provides an interventional treatment method, which includes: placing the tip of the catheter into the pulmonary vein, and inflating the balloon to fix the catheter; turning on the electric motor to drive the treatment transducer The pulmonary veins are electrically isolated by the treatment transducer and the imaging transducer, and the three-dimensional model of the heart is constructed through the imaging transducer; after the electrical isolation of the damage and the three-dimensional model of the heart are built Afterwards, the gas in the balloon is withdrawn, and the catheter is moved out to the triggering foci outside the pulmonary vein, so as to perform a single-point ablation of the triggering foci through the therapeutic transducer.

Further, electrically isolating the pulmonary vein from damage by the therapeutic transducer, and constructing a three-dimensional model of the heart by the imaging transducer includes:

The therapeutic transducer rotates under the drive of the electric motor, and electrically isolates the pulmonary veins from damage during the rotation. The imaging transducer rotates under the drive of the electric motor, and obtains images of different sections. Two-dimensional images of the heart, and a three-dimensional model of the heart is constructed based on the obtained two-dimensional images of the heart.

Further, the method further includes:

When single-point ablation of the triggering focus is performed by the therapeutic transducer, the electric motor is turned off.

It can be seen from the above that the technical solution provided by this application uses ultrasound to perform heart modeling, catheter positioning, and an innovative treatment method for low-frequency ultrasound injury ablation. Specifically, a catheter integrated with an ultrasound transducer can be designed and manufactured. The front end of the catheter is a mapping electrode, the back is an inflatable balloon, and the back is a therapeutic transducer and an imaging transducer. Both are linked with electric motors. In practical applications, the tip of the catheter can be first placed into the pulmonary vein, the balloon is inflated to fix the catheter, the electric motor is turned on to rotate the therapeutic transducer and the imaging transducer, and the ultrasound is obtained while electrically isolating the injury along the pulmonary vein. Images construct a three-dimensional model of the heart. Then, after the synchronization of the pulmonary vein isolation and the construction of the three-dimensional heart model is completed, the gas in the balloon is withdrawn, the catheter is removed, and the single-point ablation is performed to the triggering focus outside the pulmonary vein. The technical solution provided by this application combines the advantages of current thermal ablation and cold ablation, PVI is simple and fast to operate, and can damage any lesion outside the pulmonary vein.

Description of the drawings

In order to more clearly describe the embodiments of the present application or the technical solutions in 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 drawings in the following description are only exemplary. For those of ordinary skill in the art, other implementation drawings can be derived from the provided drawings without creative work.

Figure 1 is a schematic structural diagram of an interventional treatment system in an embodiment of the application;

Figure 2 is a step diagram of the interventional treatment method in an embodiment of the application.

Detailed ways

The following specific examples illustrate the implementation of this application. Those familiar with this technology can easily understand the other advantages and effects of this application from the content disclosed in this specification. Obviously, the described examples are part of this application. , Not all examples. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

The following examples are used to illustrate the application, but are not used to limit the scope of the application.

The present application provides an interventional treatment system. Please refer to FIG. 1. The interventional treatment system includes a catheter 4 and a holding member 9 connected to each other. A mapping electrode 1 is embedded in the front end of the catheter 4, and the catheter 4 is A balloon 3 is installed, a therapeutic transducer 5 and an imaging transducer 6 are sequentially arranged inside the catheter 4, an electric motor 8 is arranged in the holding member 9, and the therapeutic transducer 5 and the The imaging transducer 6 is connected to the electric motor 8 and can be driven to rotate by the electric motor 8.

In one embodiment, when the front end of the catheter 4 is placed into the pulmonary vein, the balloon 3 is inflated to fix the catheter 4.

In one embodiment, the therapeutic transducer 5 and the imaging transducer 6 are connected to the electric motor 8 through a motor-linked guide wire 7.

In one embodiment, the front end of the catheter 4 is embedded with two mapping electrodes 1 spaced apart at a fixed interval, and the two mapping electrodes 1 are connected to an internal circuit through an electrode guide wire 2.

In one embodiment, the therapeutic transducer 5 rotates under the drive of the electric motor 8 and electrically isolates the pulmonary veins from damage during the rotation. The imaging transducer 6 is connected to the electric motor 8 It rotates under the driving force of, and obtains two-dimensional images of the heart of different sections, and constructs a three-dimensional model of the heart based on the obtained two-dimensional images of the heart.

In one embodiment, after the electrical isolation of the damage and the modeling of the three-dimensional model of the heart are completed, the gas in the balloon 3 is extracted, and the catheter 4 is removed to the triggering focus outside the pulmonary vein to pass the treatment The transducer 5 performs single-point ablation on the trigger focus.

Specifically, the therapeutic transducer emits a low-frequency ultrasonic wave perpendicular to the long axis of the catheter, and when it is not rotating, it directly faces the tip electrode during bending.

In one embodiment, the electric motor 8 is turned off when the triggering focus is single-point ablated by the therapeutic transducer 5.

Specifically, the treatment transducer emits low-frequency ultrasound to damage the heart tissue, similar to an ultrasonic knife. The treatment transducer rotates 360 degrees along the long axis of the catheter, and the emitted linear low-frequency ultrasound draws a circle along the pulmonary vein orifice for treatment. At the same time, the rotation of the imaging transducer will obtain two-dimensional images of the heart in different sections, thereby constructing the heart Three-dimensional model.

The imaging transducer can be understood as a strip-shaped back plate with N ultrasonic probes in sequence, and each probe can be understood as a point-shaped linear distance measurement (the flight time difference between sound wave emission and echo reception * speed of sound). In the two-dimensional plane of the ultrasound array, the probe can be probed at different angles (range from 0 to 180°) and probed at a certain angular interval (for example, 0.1° increments), so that the spatial depth information and return of a two-dimensional plane can be obtained. Wave intensity information. Then, through the rotation of the ultrasound array itself (0-360°, 0.1° increments), the distance and echo intensity information in the three-dimensional space are obtained, so as to construct a three-dimensional space model centered on the ultrasound array.

The imaging transducer has been constantly and periodically refreshing the three-dimensional image of the scanned space. At the same time, it scans and locates the position of the treatment transducer and the mapping electrode on the catheter, fitting the real-time shape and relative position of the catheter in the heart, and Through the 3D matching technology, correlate the changes in the front and back positions of the catheter.

Please refer to FIG. 2. This application also provides an interventional treatment method applied to the above-mentioned interventional treatment system, and the method includes:

S1: Place the tip of the catheter into the pulmonary vein and inflate the balloon to fix the catheter;

S2: Turn on the electric motor to drive the treatment transducer and the imaging transducer to rotate, and electrically isolate the pulmonary vein from damage by the treatment transducer, and construct a three-dimensional model of the heart by the imaging transducer ；

S3: After the electrical isolation of the injury and the modeling of the three-dimensional model of the heart are completed, the gas in the balloon is extracted, and the catheter is moved out to the triggering foci outside the pulmonary vein, so that the therapeutic transducer can trigger the trigger Single point ablation of the lesion.

In one embodiment, electrically isolating the pulmonary vein from damage by the therapeutic transducer and constructing a three-dimensional model of the heart by the imaging transducer includes:

In one embodiment, the method further includes:

It can be seen from the above that the technical solution provided by this application uses ultrasound to perform heart modeling, catheter positioning, and an innovative treatment method for low-frequency ultrasound injury ablation. Specifically, a catheter integrated with an ultrasound transducer can be designed and manufactured. The front end of the catheter is a mapping electrode, the back is an inflatable balloon, and the back is a therapeutic transducer and an imaging transducer. Both are linked with electric motors. In practical applications, the tip of the catheter can be first placed into the pulmonary vein, the balloon is inflated to fix the catheter, the electric motor is turned on to rotate the treatment and imaging transducer, and the ultrasound image of the heart is obtained while electrically isolating the damage along the pulmonary vein to construct a three-dimensional heart model. Then, after the synchronization of the pulmonary vein isolation and the construction of the three-dimensional heart model is completed, the gas in the balloon is withdrawn, the catheter is removed, and the single-point ablation is performed to the triggering focus outside the pulmonary vein. The technical solution provided by the present application combines the advantages of current thermal ablation and cold ablation, PVI is simple and fast to operate, and can damage the pulmonary vein and any lesion outside the pulmonary vein.

Although this application has been described in detail above with general descriptions and specific examples, some modifications or improvements can be made to it on the basis of this application, which is obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of this application belong to the scope of protection claimed by this application.

Claims

An interventional treatment system, characterized in that the interventional treatment system comprises a connected catheter and a holding member, wherein a mapping electrode is embedded in the front end of the catheter, a balloon is installed on the catheter, and the inside of the catheter A therapeutic transducer and an imaging transducer are arranged in sequence, an electric motor is arranged in the holding member, and both the therapeutic transducer and the imaging transducer are connected to the electric motor and can be The electric motor drives rotation.
The interventional treatment system according to claim 1, wherein after the front end of the catheter is placed in the pulmonary vein, the balloon is inflated to fix the catheter.
The interventional treatment system according to claim 1, wherein the therapeutic transducer and the imaging transducer are connected to the electric motor through a motor-linked guide wire.
The interventional treatment system according to claim 1, wherein two mapping electrodes at fixed intervals are embedded in the front end of the catheter, and the two mapping electrodes are connected to the internal circuit through an electrode guide wire.
The interventional therapy system according to claim 1, wherein the therapeutic transducer is driven by the electric motor to rotate, and during the rotation, the pulmonary veins are damaged and electrically isolated; the imaging transducer It rotates under the drive of the electric motor to obtain two-dimensional images of the heart of different sections, and constructs a three-dimensional model of the heart based on the obtained two-dimensional images of the heart.
The interventional treatment system according to claim 5, wherein after the electrical isolation of the injury and the modeling of the three-dimensional model of the heart are completed, the gas in the balloon is extracted, and the catheter is moved out to the triggering focus outside the pulmonary vein , In order to perform single-point ablation of the triggering focus through the therapeutic transducer.
The interventional treatment system according to claim 6, wherein the electric motor is turned off when the triggering focus is single-point ablated by the therapeutic transducer.
An interventional treatment method applied in the interventional treatment system according to any one of claims 1 to 7, wherein the method comprises:

Place the tip of the catheter into the pulmonary vein and inflate the balloon to fix the catheter;

Turn on the electric motor to drive the treatment transducer and the imaging transducer to rotate, and electrically isolate the pulmonary veins from damage by the treatment transducer, and construct a three-dimensional heart model through the imaging transducer;

After the electrical isolation of the injury and the modeling of the three-dimensional model of the heart are completed, the gas in the balloon is extracted, and the catheter is moved out to the triggering foci outside the pulmonary vein, so that the triggering foci can be performed by the therapeutic transducer Single point ablation.
The method according to claim 8, characterized in that, electrically isolating the pulmonary vein from damage by the therapeutic transducer, and constructing a three-dimensional model of the heart by the imaging transducer comprises:

The therapeutic transducer rotates under the drive of the electric motor, and electrically isolates the pulmonary veins from damage during the rotation. The imaging transducer rotates under the drive of the electric motor, and obtains images of different sections. Two-dimensional images of the heart, and a three-dimensional model of the heart is constructed based on the obtained two-dimensional images of the heart.
The method according to claim 8, wherein the method further comprises:

When single-point ablation of the triggering focus is performed by the therapeutic transducer, the electric motor is turned off.