WO2013117152A1

WO2013117152A1 - Interventional medical catheter and three-dimensional mapping device applying same

Info

Publication number: WO2013117152A1
Application number: PCT/CN2013/071387
Authority: WO
Inventors: 张国旺; 彭亚辉; 孙毅勇
Original assignee: 上海微创电生理医疗科技有限公司
Priority date: 2012-02-06
Filing date: 2013-02-05
Publication date: 2013-08-15
Also published as: CN202537494U

Abstract

Disclosed is an interventional medical catheter and a three-dimensional mapping device applying same, comprising an insert tube (1), at least two sensing elements (2), several electrodes (3) and a catheter handle (4). The insert tube (1) comprises a catheter body (7) having a linear shape and an annular shaped helical structure (8) coupled with the head end of the catheter body. The several electrodes (3) are located on the annular shaped helical structure (8). At least two sensing elements (2) are both located on the annular shaped helical structure (8), or at least one is located on the catheter body (7) and at least one of the others is located on the annular shaped helical structure (8). One end of the catheter handle (4) is secured with the tail end of the catheter body (7) and the other end is provided with a connector (5). Since the sensing elements can detect the three-dimensional coordinates and the direction of the magnetic field therein, the position and morphology of the annular shaped helical structure can be calculated. The image morphology of the catheter can be conveniently reproduced by utilizing existing three-dimensional image processing software technology; therefore, the positioning and the shape of the annular shaped helical structure can be reproduced.

Description

An invasive medical catheter and a three-dimensional mapping device using the same

The present application relates to the field of medical device technology, and in particular, to an interventional medical catheter having a positioning function and a three-dimensional mapping device using the medical catheter. Background technique

Invasive medical catheters with a ring-shaped configuration at the head end (such as a circumferential pulmonary vein mapping catheter) are a type of catheter that is common in clinical interventional procedures. In the clinical operation of transcatheter radiofrequency (RF) ablation for arrhythmias caused by atrial fibrillation, circumferential pulmonary vein mapping catheters are often used to examine electrical signals in the pulmonary veins or in the pulmonary veins. In performing such procedures, the surgeon does not directly view the position of the patient's heart chamber and the position and shape of the end of the circumferential lung catheter. At present, X-ray images and injection contrast agents are mainly used to determine the position of the pulmonary vein and the position and shape of the circumferential pulmonary catheter. Since this X-ray image is a two-dimensional image, it is not easy for doctors to judge the actual structure and position of the three-dimensional heart chamber and catheter, and it requires a lot of experience, and too much dose of X-rays can cause harm to the patient, which is inconvenient to apply. In recent years, with the development of science and technology, the three-dimensional positioning technology based on the mixing of magnetic field, electric field or electric field magnetic field can be used to locate the head end of the catheter, and the shape of the heart chamber can be reconstructed by computer three-dimensional cardiac electrophysiological mapping technology. This is clinically obvious to facilitate the implementation of such surgery. However, the existing magnetic field-based positioning techniques are directed to straight-line catheters, and for intervening medical catheters with a ring-shaped structure at the head end, no relevant records have been found. Utility model content

In view of this, the embodiment of the present application provides an interventional medical catheter and a three-dimensional mapping device using the medical catheter, and a ring structure of the end of the interventional medical catheter is disposed Positioning the sensor to position and shape the annular structure of the interventional medical catheter tip. In order to achieve the above object, the technical solution provided by the embodiments of the present application is as follows: An interventional medical catheter includes: an insertion tube, at least two sensing elements, a plurality of electrodes, and a catheter handle, wherein:

The insertion tube comprises a linear catheter body and an annular spiral structure connected to the head end of the catheter body, the annular spiral structure has memory elasticity, and each part of the annular spiral structure is elastically uniform;

The plurality of electrodes are located on the annular spiral structure;

The at least two sensing elements are all located on the annular spiral structure, or at least one of the at least two sensing elements is located on a catheter body connected to the annular spiral structure, and at least one other is located in the ring Spiral structure

One end of the catheter handle is fixed to the tail end of the catheter body, and the other end is provided with a connector to be fixed. Preferably, the sensing element is a magnetic positioning sensor. Preferably, the magnetic field sensor is a 5-DOF magnetic field sensor or a 6-DOF magnetic field sensor. Preferably, the number of the sensing elements is two. Preferably, the axes of the two sensing elements are perpendicular and the lines connecting the centers of the two sensing elements intersect the axis of the annular spiral. Preferably, the axes of the two sensing elements are parallel and the lines connecting the centers of the two sensing elements intersect the axis of the annular spiral. Preferably, a sensing element is located in the annular spiral structure and the conduit body The location of the connection, the other sensing element is located in the middle of the annular spiral. A three-dimensional mapping device includes: an interventional medical catheter, an extension cable, a signal extraction device, a signal processing device, and a display device, wherein:

The interventional medical catheter includes: an insertion tube, at least two sensing elements, a plurality of electrodes, and a catheter handle, the insertion tube including a linear catheter body and an annular spiral structure connected to the head end of the catheter body, The annular spiral structure has memory elasticity, and each part of the annular spiral structure is elastically uniform;

The plurality of electrodes are located on the annular spiral structure;

The at least two sensing elements are located on the annular spiral structure, or at least one of the at least two sensing elements is located on a catheter body connected to the annular spiral structure, and at least one other is located in the annular spiral Structurally

One end of the catheter handle is fixed to the tail end of the catheter body; the other end is provided with a connector;

One end of the extension cable is fixed to the connector on the handle, and the other end is connected to the signal extraction device;

An input end of the signal processing device is coupled to the signal extraction device, and an output terminal is coupled to the display device. Preferably, the apparatus further comprises: a data storage device storing the initial characteristic parameters of the annular spiral structure, the data storage device being located within the catheter handle. It can be seen from the above technical solution that the interventional medical catheter provided by the embodiment of the present application has a main body portion including: a linear catheter body and an annular spiral structure connected to the head end of the catheter body, and a plurality of annular spiral structures are disposed in the annular spiral structure. In addition, at least two sensing elements are disposed in the annular spiral structure, or at least one sensing element is disposed on the catheter body connected to the annular spiral structure, and at least one sensing element is disposed on the annular spiral structure. In actual use, the invasive medical catheter annular spiral structure segment is placed in the magnetic field region, at which time the sensing element can detect the three-dimensional coordinates and direction in the magnetic field in which it is located, and according to the above data, the position of the annular spiral structure can be calculated and Morphology, at the same time The image shape of the catheter can be conveniently reproduced by using the well-known three-dimensional software image processing technology, so that the annular spiral structure on the interventional medical catheter can be positioned. DRAWINGS

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings to be used in the embodiments or the description of the prior art will be briefly described below. Obviously, the drawings in the following description are only It is a few embodiments described in the present application, and other drawings can be obtained from those skilled in the art without any creative work. 1 is a schematic structural view of an invasive medical catheter provided by an embodiment of the present invention; FIG. 2 is a schematic structural view of a toroidal spiral structure according to an embodiment of the present application; 4 is a schematic structural diagram of a three-dimensional mapping device provided by an embodiment of the present application. detailed description

The technical solutions in the embodiments of the present application are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present application. The embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the scope of the present application. Embodiment 1;

FIG. 1 is a schematic structural view of an interventional medical catheter provided by an embodiment of the present application. FIG. 2 is a schematic structural diagram of a toroidal spiral structure provided by an embodiment of the present application. FIG. 3 is a schematic cross-sectional view of a toroidal spiral structure provided by an embodiment of the present application. As shown in Figures 1, 2 and 3, the interventional medical catheter comprises: an insertion tube 1, at least two sensing elements 2, a plurality of electrodes 3 and a catheter handle 4, wherein: the insertion tube 1 is guided The tube body 7 and the annular spiral structure 8 are composed. As shown in Fig. 1, the catheter body 7 has a linear configuration, and the annular spiral structure 8 is connected to the catheter body 7 and is located at the head end of the catheter body 7. In the embodiment of the present application, "head end" refers to one end of the catheter that enters the patient during surgery, and "tail end" refers to one end that is close to the operator during surgery. One end of the operating handle 4 is fixed to the tail end of the catheter body 7, and the other end is provided with a connector 5, and the connector 5 functions to be connected to the cable. In the embodiment of the present application, the material of the annular spiral structure 8 contains a memory elastic material and has memory elasticity. This is because the invasive medical catheter needs to insert the insertion tube into the lumen of the human body when in use, and the annular spiral structure 8 is made of a memory elastic material, such as a memory alloy, so that the annular spiral structure 8 has elasticity and memory function, so that Before the insertion, the annular spiral structure 8 can be straightened and transported through the sheath to the human body. When inserted into the position, the annular spiral structure 8 extends out of the sheath tube and automatically returns to the original state of the memory. In addition, the elasticity of each part of the annular spiral structure 8 is uniform, in order to ensure that the annular spiral structure 8 is in the human body cavity, and each part can be uniformly deformed after being stressed. As shown in FIG. 3, at least two sensing elements 2 and a plurality of electrodes 3 are located on the annular spiral structure 8. In the embodiment of the present application, the sensing element 2 can adopt a magnetic positioning sensor, and the sensing element 2 functions to detect the three-dimensional coordinates and the tangential direction of the point where the sensing element 2 is located on the annular spiral structure 8, thereby determining the annular spiral structure 8 Position and simulate the shape of the annular spiral structure 8. In actual use, the single magnetic field sensor can be a 5-DOF magnetic field sensor or a 6-DOF magnetic field sensor. As shown in FIG. 3, in the embodiment of the present application, the number of the sensing elements 2 is two, and in order to more accurately calculate and simulate the shape of the spiral structure, the connection and ring of the center of the two sensing elements 2 The axes of the helical structures 8 intersect, i.e., the two sensing elements 2 are located at one end of a diameter of the annular helical structure 8. In the embodiment of the present application, as shown in FIG. 3, one of the two sensing elements 2 may be located on the catheter body 7, and its position is connected to the annular spiral structure 8, and the other sensing element 2 may be Located in the middle of the annular spiral structure 8, and at this time the axes of the two sensing elements 2 can be perpendicular. In addition, the two sensing elements 2 can also all be located in a circular spiral Within structure 8, the axes of the two sensing elements 2 are now parallel. In either case, as long as the line connecting the centers of the two sensing elements 2 intersects the axis of the annular spiral structure, the measured data can greatly improve the accuracy of the reconstruction of the ring structure. The interventional medical catheter provided by the embodiment of the present application, because the sensing element 2 can detect the three-dimensional coordinates and direction in the magnetic field in which it is located, and assumes that each part of the annular spiral annular structure 8 is uniformly stressed in the heart chamber and forms a standard. The circular spiral structure is equivalent to knowing the coordinates of the starting point position of the annular spiral structure 8, the extending direction of the duct main body 7, the three-dimensional coordinates and the tangential direction of the middle position (or more other positions) of the annular spiral structure 8, and It is also possible to provide a reservoir within the catheter handle such that initial state parameters of the catheter toroidal helical structure, such as helical diameter, length, sensor element distribution, electrode distribution, etc., can be obtained from a reservoir located within the catheter handle. According to the above data, the position and shape of the annular spiral structure can be calculated, and the image shape of the catheter and the relative position of each electrode can be conveniently reproduced by using the well-known three-dimensional software image processing technology. When the force of each segment of the annular spiral structure is uneven, there is an error between the spiral shape and the actual shape simulated by the calculation method of the standard spiral, and the fewer the positioning sensors on the annular spiral structure, the more the error. In actual clinical practice, when the interventional medical catheter is a circumferential pulmonary vein catheter, when the circumferential pulmonary vein catheter is located outside the pulmonary vein, the force is less deformed and smaller; when located in the pulmonary vein, the force is slightly Large, but the force is relatively uniform, and the annular spiral structure 8 at the tip end of the catheter body 1 forms an approximately standard spiral shape. Embodiment 2:

FIG. 4 is a schematic structural diagram of a three-dimensional mapping device according to an embodiment of the present application. As shown in FIG. 4, the three-dimensional mapping device comprises: an interventional medical catheter 100, an extension cable 200, a signal extraction device 300, a signal processing device 400, and a display device 500, wherein: components and parts of the interventional medical catheter 100 Connection relationship between the embodiments It has been described in detail in the first, and will not be described again here. The signal extraction device 300 is connected to the extension cable 200 for receiving a detection signal of the sensor element 2 transmitted through the extension cable 200, and transmits a detection signal of the sensor element 2 to the signal processing device 400. Input end of signal processing device 400 and signal extracting device

300 phase connection, the output end is connected to the display device 500, and the signal processing device 400 is used for performing arithmetic processing on the detection signal received by the signal extraction device 300 to obtain the degree of bending of the annular spiral structure. In practical applications, the signal processing device 400 Can be a computer. The display device 500 is configured to simulate the curved shape of the calculated annular spiral structure, and may be a device such as a liquid crystal panel. In the embodiment of the present application, in order to conveniently obtain the initial characteristic parameters of the annular spiral structure, a data storage device may be disposed in the catheter handle 4 of the interventional medical catheter 100, and the annular spiral structure may be stored in the data storage device. All initial characteristic parameters, such as the initial diameter of the annular spiral structure, the number and distribution of the electrodes, the total length of the annular spiral structure, etc., when the interventional medical catheter 100 is connected to the signal extraction device 300, the signal extraction device 300 Data within the data storage device can be acquired and transmitted to signal processing device 400 for calculation. In addition, the signals collected by the sensing elements and the electrodes on the interventional medical catheter 100 are generally weak. In order to facilitate subsequent signal processing, in the embodiment of the present application, an amplification module may be disposed in the signal extraction device 300 to amplify The module is used to amplify the signals collected by the sensing elements and electrodes. The following is a typical treatment of atrial fibrillation surgery, wherein the interventional medical catheter is a circumferential pulmonary vein mapping catheter, and the clinical application process of the three-dimensional mapping device provided by the embodiment of the present application is described in detail. Before proceeding, the magnetic field generating device is first placed at a suitable position on the operating bed so that the patient's heart chamber is located within the optimal detection area of the magnetic field positioning system. The operator, such as a cardiologist, then inserts the circumferential lung catheter into the patient through the patient's vasculature. To facilitate the passage of the catheter's spiral annulus, the annular helix is straightened and passed through the sheath to the patient. In the right atrium of the heart, the puncture room is inserted into the left atrium, and then the annular spiral structure at the tip end of the catheter body is released into the left atrium cavity, and the annular spiral structure is restored to its original state by its own memory elasticity. At this time, the magnetic positioning sensor on the annular spiral structure is located in the localized magnetic field region. The connector interface on the catheter handle of the circumferential lung catheter is connected to the interface unit of the signal extraction device through an extension cable, and the signal extraction device can perform preliminary processing on the positioning signal received by the magnetic positioning sensor and convert it into a digital signal, and the signal extraction device The initial characteristic parameters of the annular spiral conduit stored in the data storage device within the catheter handle are read. And the signal control device sends all of the signals to the signal processing device, the signal processing device can include a computer and other digital signal processors, and the signal processing device determines the position of the head end of the circumferential lung catheter according to the obtained position information and the annular spiral structure The shape is reconstructed and the position and shape of the head end of the circumferential lung catheter is displayed on the display. When the operator operates the catheter handle to move the circumferential lung catheter in different positions within the left atrium, the magnetic positioning sensor acquires the positioning data and can be updated in real time, and the catheter image on the display is also updated at any time. The operator can adjust the position of the catheter to the target area based on feedback from the catheter image on the display. When the circumferential pulmonary catheter enters the pulmonary vein, the catheter is moved along the pulmonary vein and the trajectory of the spiral loop is recorded to obtain the position and shape of the pulmonary vein. When the circumferential lung catheter is located within the heart chamber, a three-dimensional model of the left atrium inner wall can be reconstructed using well-known algorithms depending on the location and shape of the annular structure. When establishing a three-dimensional model of the left atrium inner wall, the operator can use the radiofrequency ablation catheter with positioning function to operate the catheter to make the ablation electrode reach according to the position indication of the ablation electrode on the ablation catheter according to the established three-dimensional model of the cardiac chamber. Target location, then Ablation of the tissue at the target site. The above description is only a preferred embodiment of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments are obvious to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the application. Therefore, the application is not limited to the embodiments shown herein, but the broadest scope consistent with the principles and novel features disclosed herein.

Claims

Claim

An interventional medical catheter, comprising: an insertion tube, at least two sensing elements, a plurality of electrodes, and a catheter handle, wherein:

The plurality of electrodes are located on the annular spiral structure;

One end of the catheter handle is fixed to the tail end of the catheter body, and the other end is provided with a connector.

2. The medical catheter of claim 1, wherein the sensing element is a magnetic positioning sensor.

The medical catheter according to claim 2, wherein the magnetic field sensor is a 5-DOF magnetic field sensor or a 6-DOF magnetic field sensor.

The medical catheter according to claim 1, wherein the number of the sensing elements is two.

5. The medical catheter of claim 4 wherein the axes of the two sensing elements are perpendicular and the lines connecting the centers of the sensing elements intersect the axis of the annular spiral structure.

6. The medical catheter according to claim 4, wherein two axes of the sensing elements are parallel, and a line connecting the centers of the two sensing elements and the annular snail The axes of the spin structures intersect.

7. The medical catheter of claim 6, wherein one sensing element is located in a position where the annular helical structure is coupled to the catheter body and another sensing element is located in a central portion of the annular helical structure.

A three-dimensional mapping apparatus, comprising: an interventional medical catheter, an extension cable, a signal extraction device, a signal processing device, and a display device, wherein:

The interventional medical catheter comprises: an insertion tube, at least two sensing elements, a plurality of electrodes, a catheter handle, the insertion tube comprising a linear catheter body and an annular spiral structure connected to the head end of the catheter body, The annular spiral structure has memory elasticity, and each part of the annular spiral structure is elastically uniform;

The plurality of electrodes are located on the annular spiral structure;

One end of the catheter handle is fixed to the tail end of the catheter body, and the other end is provided with a connector;

One end of the extension cable is fixed to the connector on the catheter handle, and the other end is connected to the signal extraction device;

An input of the signal processing device is coupled to the signal extraction device, and an output is coupled to the display device.

9. The apparatus of claim 8, further comprising: a data storage device storing an initial characteristic parameter of the annular spiral structure, the data storage device being located within the catheter handle.