WO2023142361A1

WO2023142361A1 - Double-layer basket catheter device

Info

Publication number: WO2023142361A1
Application number: PCT/CN2022/101574
Authority: WO
Inventors: 冯君; 黄龙; 王本琪; 磨志岱; 李龙
Original assignee: 心航路医学科技(广州)有限公司
Priority date: 2022-01-28
Filing date: 2022-06-27
Publication date: 2023-08-03
Also published as: CN114668482A

Abstract

Disclosed in the present invention is a double-layer basket catheter device, comprising a catheter assembly and a top guide. A first basket has one end connected to a distal end of the catheter assembly and the other end connected by means of the top guide, and a plurality of first electrodes are uniformly arranged on the first basket. A second basket has one end connected to the distal end of the catheter assembly and the other end connected by means of the top guide, and a plurality of second electrodes are uniformly arranged on the second basket. The first basket and the second basket can be synchronously unfolded or contracted by operating the top guide; and the second basket is located inside the first basket. The first electrodes can acquire cardiac electrical signals when being in contact with or being not in contact with a tissue, the second electrodes acquire the cardiac electrical signals in a non-contact manner, and acquired information can be used for reflecting a spreading mode of cardiac electrical activities in different states. The device helps a clinician to determine an arrhythmia mechanism, and accordingly formulates a corresponding treatment strategy.

Description

Double Basket Catheter Set

technical field

The invention relates to the technical field of catheter devices, in particular to a double-layer basket catheter device.

Background technique

Electrophysiology catheters are often used to map electrical activity within the heart. Various electrode designs are known for different purposes. In particular, catheters with basket-shaped electrode arrays are known.

Basket catheters typically have an elongated catheter body and a basket-shaped electrode assembly mounted at the distal end of the catheter body. The basket assembly has a proximal end and a distal end and includes a plurality of splines connected at the proximal and distal ends thereof. Each spline includes at least one electrode. The basket assembly has an expanded arrangement in which the spines arc radially outward and a collapsed arrangement in which the splines are arranged generally along the axis of the catheter body. The catheter may also include a distal position sensor mounted at or near the distal end of the basket-shaped electrode assembly, and a proximal position sensor mounted at or near the proximal end of the basket-shaped electrode assembly. In use, the coordinates of the distal position sensor relative to the coordinates of the proximal sensor can be determined, and this can be considered together with known information about the curvature of the splines of the basket shape mapping assembly to find the position of each spline. The location of at least one electrode of the key.

However, the basket in the existing basket catheter is usually one layer. After being introduced into the catheter, only one effect of the electrode can be realized, that is, only contact mapping or non-contact mapping can be realized. It cannot be realized at the same time and arbitrarily switched between the two.

Contact mapping and non-contact mapping are two common mapping methods in the field of cardiac electrophysiology. Contact mapping mainly collects cardiac electrical signals by calculating the potential difference between two electrodes. The local electrical signal collected at the corresponding position of the electrode. Obtain potential amplitude information of local cardiac electrical activity. At the same time, it is compared with the reference potential at a fixed position to obtain the information of the excitation time, so as to analyze the direction of cardiac electrical conduction. The single acquisition range of contact mapping is limited to the local myocardial tissue that the electrodes touch. After the mapping is completed, the electrical activity information collected by the catheter at various parts of the heart chamber at different time points is spliced into a complete cardiac electrical conduction pattern. Since a fixed time reference is required, information collected at different times needs to be spliced into a complete map. Therefore, contact mapping is mainly aimed at stable atrial or ventricular arrhythmias with good temporal and spatial consistency.

Non-contact mapping is different from traditional contact mapping methods. First, the electrodes do not need to touch the tissue, and multiple electrodes can be combined to obtain a wider range of myocardial electrical activity at different angles. In this way, a wider range of ECG information can be obtained per unit time. Then through the inverse calculation of the signals recorded by multiple electrodes, the method of analyzing the electrical activity trajectory. Second, due to non-contact mapping, a wider range of myocardial electrical activity information can be obtained per unit time. The reliance of contact mapping on rhythm stability and a fixed time reference can be eliminated. Therefore, it can provide more meaningful help for the exploration of the mechanism of unstable arrhythmia, especially atrial fibrillation. Third, the method of non-contact mapping does not rely on the abutment of the catheter to the surface of the heart. Reduces mechanical stress due to catheter and heart. Reduce or avoid complications such as cardiac perforation.

If the design of the basket catheter for contact and non-contact mapping is integrated. While further improving the mapping efficiency and resolution of the existing contact mapping. Incorporate the advantages of non-contact mapping. Further help the exploration of the electrophysiological mechanism of arrhythmia. Help clinicians formulate more precise treatment strategies. Improve the success rate of catheter ablation.

technical solution

According to one aspect of the present invention, a double-layer basket catheter device is provided, comprising: a catheter assembly;

guide head;

The first basket, one end is connected to the distal end of the catheter assembly, and the other end is connected through a guide head, and a plurality of first electrode bands from the far end to the proximal end of the first basket are evenly distributed on the first basket, and the first electrodes are the strip includes a plurality of first electrodes;

The second basket, one end is connected to the far end of the catheter assembly, and the other end is connected by a guide head, a plurality of second electrode bands from the far end to the proximal end of the second basket are evenly distributed on the second basket, and the second The electrode strip includes a plurality of second electrodes;

The first net basket and the second net basket can be expanded or contracted synchronously through the operation of the guide head;

In the expanded state, the first net basket and the second net basket are deformed, and the second net basket is inside the first net basket.

In some embodiments, the first basket includes a plurality of evenly arranged elongated deformable first splines, and each first spline is evenly arranged with a plurality of first electrodes to form a first electrode belt; The second basket includes a plurality of evenly arranged strip-shaped deformable second splines, and a plurality of second electrodes are uniformly arranged on each second spline to form a second electrode belt; a plurality of first splines The distal ends of the plurality of second splines are connected to the guide head; the proximal ends of the plurality of first splines and the plurality of second splines are connected with the distal end of the catheter assembly.

In some embodiments, each second spline in the second basket is opposite to each first spline in the first basket, or each second spline in the second basket is opposite to each second spline in the second basket. The key is opposite the gap between two adjacent first splines in the first basket.

In some embodiments, the number of the first splines is the same as or different from the number of the second splines.

In some embodiments, the number of the first electrodes is the same as or different from the number of the second electrodes.

In some embodiments, in two adjacent second electrode strips, the second electrodes are dislocated or parallelly distributed.

In some embodiments, the conduit assembly includes a retractable first conduit, the first conduit is connected to the guide head, and the first conduit controls the guide head connected to it through telescopic operation, so that the first basket, the second The expansion or contraction of the second basket.

In some embodiments, the double-layer basket conduit is a nested structure, and the diameter of the second basket is always smaller than that of the first basket at different degrees of expansion.

In some embodiments, the proximal fixation site diameter of the second basket is smaller than the proximal fixation site diameter of the first basket.

In some embodiments, the catheter assembly is provided with a bendable member for enabling the first basket and the second basket to bend in at least one direction by 70°-270° relative to the axis of the catheter assembly.

In some embodiments, the distal ends of the first basket and the second basket are connected by a guide head; the guide head is connected with the distal end of the first catheter.

In some embodiments, the proximal ends of the first spline and the second spline form a connecting sleeve and are sleeved on the connecting portion, and are connected to the distal end of the catheter assembly through the connecting portion.

In some embodiments, the distal end surface of the guide head does not protrude from the distal end surface of the first basket in the deployed state, or the distal end surface of the guide head protrudes beyond the distal end surface of the first basket in the deployed state. The distance between the end faces is less than 2mm.

In some embodiments, the guide head has a hollow cavity, and the hollow cavity is docked with the first catheter, allowing the guide wire delivered from the control handle end to pass through the distal end of the guide head.

In some embodiments, the distal end of the first spline is inserted into the interior of the guide head from the distal end of the guide head; the distal end of the second spline is inserted into the guide head from the proximal end of the guide head. Inside the guide head.

In some embodiments, the portion of the first spline inserted into the guide head is perpendicular to the axis of the catheter assembly; the portion of the second spline inserted into the guide head is parallel to the axis of the catheter assembly.

In some embodiments, the part where the first spline is inserted into the guide head and the part where the second spline is inserted into the guide head are in the same plane or at least partially overlapped.

In some embodiments, the first electrode is configured as an electrode for contact mapping and/or non-contact mapping; the second electrode is configured as an electrode for non-contact mapping.

In some embodiments, the first basket includes at least six first splines; the second basket includes at least six second splines.

In some embodiments, the number of first splines is six, eight, ten or twelve; the number of second splines is six, eight, ten or twelve.

In some embodiments, each of the first splines is provided with at least six first electrodes; each of the second splines is provided with at least six second electrodes.

In some embodiments, each of the first splines is provided with twelve first electrodes,

eight second electrodes are provided on each of said second splines; or,

Twenty first electrodes are provided on each of the first splines,

Each of the second splines is provided with eight second electrodes.

In some embodiments, the interval between two adjacent first electrodes on the same first spline is 0.5-5mm; the interval between two adjacent second electrodes on the same second spline is 0.5-5mm.

In some embodiments, a central reference electrode is provided near the distal end of the first catheter to assist the first electrode and/or the second electrode in recording the electrical activity of the heart.

In some embodiments, when the first electrode is used for mapping, the first electrode is configured as positive or negative, the central reference electrode is configured as ground, and the voltage between the first electrode and the central reference electrode is recorded. electrical signals to obtain monopolar electrograms; and/or,

When the second electrode is used for mapping, the second electrode is configured as positive or negative, and the central reference electrode is configured as ground, and the electrical signal between the second electrode and the central reference electrode is recorded to obtain a unipolar voltage. picture.

In some embodiments, a magnetic sensor is provided near the distal end of the first catheter, which can be used to locate and track the double-layer basket catheter device.

In some embodiments, the position information of the double-layer basket catheter device is obtained by collecting the magnetic channel data of the magnetic sensor and/or the electrical channel data of the central reference electrode.

In some embodiments, the first mesh basket includes a self-responsive mesh member woven by several skeletons, and the first electrode is installed on the surface of the skeleton and distributed along the surface contour of the mesh member. .

In some embodiments, the second basket includes a balloon and a number of second splines evenly arranged in the circumferential direction, and a number of second splines are arranged on the inner surface of the cavity of the balloon; the second electrode is arranged on On the second spline; the balloon is provided with several openings corresponding to the positions of the second electrodes.

In some embodiments, each of the second baskets includes a self-responsive mesh member woven by intersecting skeletons; the second electrodes are installed on the surface of the skeleton and distributed along the surface contour of the mesh member.

Beneficial effect

Beneficial effects of the present invention: In the double-layer mesh basket catheter of the present invention, the electrodes of the splines of the outer layer mesh basket are located in different cardiac chambers of the heart according to the location of the catheter, and the electrodes contacting the endocardium are used for contact mapping, without The electrodes in contact with the endocardium perform non-contact mapping at the same time; the electrodes on the splines of the inner basket do not touch the endocardium at any position in the cardiac cavity, and only perform non-contact mapping. Specifically, the catheter can collect cardiac electrical activity signals both in contact with tissue and without contact with tissue. It contains information in the form of one or more of current density, charge density, transmembrane potential, electric dipole density, local field potential, excitation time, voltage, and repolarization time. Electrodes on the first spline (outer layer) allow cardiac electrical signal acquisition with or without tissue contact. Electrodes on the second spline (inner layer) collect electrical signals from the heart in a non-contact manner. The collected information can be used to reflect the spreading pattern of cardiac electrical activity in different states. Help clinicians judge the mechanism of arrhythmia and formulate corresponding treatment strategies accordingly.

Description of drawings

Fig. 1 is a schematic perspective view of the three-dimensional structure of a double-layer basket catheter device according to one or more embodiments of the present invention.

Fig. 2 is a schematic side view of the double-layer basket catheter device shown in Fig. 1 .

Fig. 3a is a schematic front view of the expanded state of the double-layer basket catheter device shown in Fig. 1 .

Fig. 3b is a schematic front view of another embodiment of the expanded state of the double-layer basket catheter device shown in Fig. 1 .

Fig. 3c is a schematic diagram of a cross section perpendicular to the L-axis in the expanded state of the double-layer basket catheter device shown in Fig. 1 .

Fig. 3d is a schematic diagram of a section perpendicular to the L-axis in a contracted state of the double-layer basket catheter device shown in Fig. 1 .

Fig. 3e is a schematic side view of the first spline and the second spline of the double-layer basket catheter device in Fig. 1 .

Fig. 3f is a schematic diagram of the enlarged structure of part D in Fig. 3c.

Fig. 4 is a three-dimensional structural schematic diagram of a section state of the double-layer basket catheter device shown in Fig. 1 .

FIG. 5 is a schematic diagram of an enlarged structure of part A in FIG. 4 .

Fig. 6a is an enlarged structural schematic diagram of an embodiment of part B in Fig. 4 .

Fig. 6b is an enlarged structural schematic diagram of an embodiment of part B in Fig. 4 .

Fig. 6c is an enlarged structural schematic diagram of an embodiment of part B in Fig. 4 .

FIG. 7 is a perspective view of the cross-sectional state of the catheter assembly part of the double-layer basket catheter device shown in FIG. 1 .

FIG. 8 is a schematic diagram of a partial enlarged structure in FIG. 7 .

FIG. 9 is a schematic diagram of a partial enlarged structure in FIG. 8 .

Fig. 10 is a schematic cross-sectional structural view of the catheter assembly part of the double-layer basket catheter device shown in Fig. 1 .

Fig. 11 is a schematic view showing the fabrication structure of the basket part of the double-layer basket conduit device shown in Fig. 1 .

Fig. 12 is a schematic diagram of the fabrication structure of the basket part of the double-layer basket conduit device shown in Fig. 1 .

Fig. 13 is a three-dimensional structural schematic diagram of an embodiment of the double-layer basket catheter device of the present invention.

Fig. 14 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

FIG. 15 is an enlarged structural schematic diagram of part C of the embodiment in FIG. 4 .

Fig. 16 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 17 is a perspective view of the semi-expanded state of the double-layer basket catheter device shown in Fig. 16 .

Fig. 18 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 19 is a three-dimensional structural schematic diagram of an embodiment of the double-layer basket catheter device of the present invention

Fig. 20 is a schematic plan view of an embodiment of the double-layer basket catheter device of the present invention.

Fig. 21 is a schematic cross-sectional structure diagram of a contracted state of an embodiment of the double-layer basket catheter device of the present invention.

Fig. 22 is a schematic diagram of a half-expanded planar structure of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 23 is a schematic diagram of the fully expanded planar structure of the double-layer basket catheter device shown in Fig. 25 .

Fig. 24 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 25 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 26 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 27 is a schematic perspective view of an embodiment of a double-layer basket catheter device of the present invention.

Fig. 28 is a schematic diagram of the planar structure of the double-layer basket catheter device shown in Fig. 27 .

Fig. 29 is a three-dimensional structural schematic diagram of an embodiment of the double-layer basket catheter device connected to the control handle of the present invention.

Fig. 30 is a comparison diagram of experimental data between the double-layer basket catheter device and the single-layer basket catheter device of the present invention.

Reference numerals in the figure: 100-catheter assembly, 110-first catheter, 111-delivery cavity, 112-perfusion hole, 113-perfusion tube, 120-second catheter, 130-third catheter, 140-bendable member, 141- Connecting part, 142-pull wire, 150-guide wire, 160-stress sleeve, 171-first conductive strip, 172-second conductive strip, 200-first basket, 201-first spline, 300-second Basket, 301-second spline, 302-balloon, 400-first electrode, 500-second electrode, 600-guide, 601-connector, 602-fastener, 603-press buckle, 700-connection Sleeve, 701-first connection part, 702-second connection part, 800-control handle, 901-magnetic sensor, 902-central reference electrode.

Embodiments of the present invention

The present invention will be described in further detail below in conjunction with the accompanying drawings.

Embodiment one

1-2 schematically show a double-layer basket catheter device according to an embodiment of the present invention, with a proximal end and a distal end, including: a catheter assembly 100, a first basket 200, and a second basket 300 , a plurality of first electrodes 400 , a plurality of second electrodes 500 and a guide head 600 . The specific structure is as follows,

The proximal part of the catheter assembly 100 is connected to the control handle 800, and the remote basket part of the device is controlled by the control handle 800;

The first basket 200 is located at the distal end of the catheter assembly 100;

The second basket 300 is located at the distal end of the catheter assembly 100 and is located in the first basket 200, that is, the second basket 300 and the first basket 200 are distributed inside and outside;

The guide head 600 connects the distal ends of the first basket 200 and the second basket 300 , and the distal ends of the first basket 200 and the second basket 300 are jointly connected with the control deployment part of the catheter assembly 100 .

Evenly distributed on the first basket 200 are the first electrode strips extending from its far end to the proximal end, the first electrode strips are composed of several regularly arranged first electrodes 400; The second electrode strip extending from the end to the proximal end, the second electrode strip is composed of several second electrodes 500 arranged regularly. The first electrode 400 and the second electrode 500 can be selected as ablation electrodes or mapping electrodes according to their properties. The ablation electrodes can be arranged only on the distal surface of the basket; the mapping electrodes can be evenly arranged on the surface of the mesh basket. The distance between two adjacent electrodes can be the same or different. For example, if the electrode is an ablation electrode and the shape of the ablation electric field to be formed is asymmetrical, the electrodes should be set at different distances to shape the shape of the electric field; if the formed ablation The electric field is symmetrical, so the same spacing is set between the electrodes.

In order to better illustrate the various components in this embodiment, with reference to Figure 1, the axis of the catheter assembly 100 is marked as the L axis, and, with reference to Figure 1, the positive direction of the L axis is the distal direction, and the reverse direction is the proximal direction. end direction. The device will be further described in detail below in combination with the concept of the L-axis.

In conjunction with Fig. 1-2, the proximal ends of the first net basket 200 and the second net basket 300 are connected, and the proximal ends of the first net basket 200 and the second net basket 300 are provided with a connection sleeve 700 connecting the two, the connection sleeve 700 is sleeved on the connecting portion 141 and fixed; the distal ends of the first basket 200 and the second basket 300 are connected, and the distal ends of the first basket 200 and the second basket 300 are provided with guide heads connecting the two 600.

Referring to FIG. 3 , the first basket 200 includes a plurality of strip-shaped first splines 201 uniformly arranged along the rotation direction of the catheter assembly 100 axis, the first splines 201 extend along the L-axis direction, and the first electrode 400 is arranged at the second A first electrode belt is formed on a spline 201; the second basket 300 includes a plurality of bar-shaped second splines 301 uniformly arranged along the rotational direction of the catheter assembly 100 axis, and the second splines 301 extend along the L-axis direction, The second electrode 500 is arranged on the second spline 301 to form a second electrode strip. In the expanded state, the first spline and the second spline deform to form a bow-like shape.

3a-3f, on the plane perpendicular to the L-axis, the second splines 301 and the first splines 201 are alternately arranged along the circumferential direction of the double-layer basket conduit device, that is, each second spline 301 is adjacent to each other. The gaps between the two first splines 201 are opposite, and the second splines 301 are located in the gap between the adjacent two first splines 201, and are arranged in an interspersed manner, avoiding the first basket of the outer layer 200 causes shelter to the second net basket 300 of inner layer. Of course, each second spline 301 can also be opposite to the first spline 201 . The electrodes can protrude beyond the surface of the spline or be flush with the surface of the spline.

In this embodiment, the expanded shape of the net basket can be spherical, oblate spherical, pear-shaped or other shapes. After the basket is unfolded, the maximum diameter of the basket is 16-28mm, preferably 20mm in diameter. Under the condition of ensuring that the basket is smaller, the maximum unfolded posture of the basket can be close to the vestibule of the atrium and pulmonary veins, and can accurately locate the vestibule of the atriopulmonary veins .

4-5, 7-10, the catheter assembly 100 includes a first catheter 110, a second catheter 120, and a third catheter 130 that are socketed along the radial direction perpendicular to the L-axis, and the first catheter 110 is connected to the second catheter. 120 expands and contracts along the L-axis direction, and the distal end of the first catheter 110 is connected to the proximal end of the guide head 600;

The bendable member 140 is inserted at the distal end of the third catheter 130 . The bendable member 140 includes a connecting portion 141 and two symmetrically distributed pull wires 142 . The proximal end of the connection part 141 is inserted into the distal end of the third catheter 130, the connection part 141 is provided with a lumen for the first catheter 110 and the second catheter 120 to penetrate, and the second catheter 120 extends to the distal surface of the connection part 141 , the first catheter 110 completely penetrates the lumen of the connection part 141 and is connected to the proximal end of the guide head 600 . The backguy 142 is arranged in the compartment between the third catheter 130 and the second catheter 120, and the backguy 142 is covered with a protective sheath; the far end of the backguy 142 is connected to the proximal end of the connection part 141; specifically, the far end of the backguy 142 The end is set as a ball, and the proximal end of the connection part 141 is provided with a groove engaging with the distal ball of the pull wire 142 . By pulling one of the pull wires 142, the bendable member can be controlled to bend in the direction of the pull wire 142, so that the first basket 200 and the second basket 300 can be bent in at least one direction relative to the axis L of the catheter assembly 100 70°-270°.

In order to conduct electricity to the electrodes on the basket, the catheter assembly 100 also includes conductive wires, which can be embedded on the wall of a certain catheter, or installed in a compartment formed between two catheters.

In some other implementations, as shown in FIG. 10 , the catheter assembly 100 can also use conductive strips instead of conductive wires to conduct electricity to the electrodes. Specifically, the conductive strip is installed in the compartment formed between the first conduit 110 and the third conduit 130, and the conductive strip includes several first conductive strips 171 that conduct electricity to the first electrode 400 on the first spline 201 and conduct to the first electrode 400 on the first spline 201. The second electrode 500 on the second spline 301 conducts a plurality of second conductive strips 172 .

Multiple first splines 201 can share one first conductive strip 171, preferably, two first splines 201 share one first conductive strip 171; optionally, three, four or five first conductive strips 171 can also be used. The splines 201 share a first conductive bar 171 . Exemplarily, when the first basket 200 is provided with ten first splines 201 , the number of first conductive strips 171 may be five.

Similarly, a plurality of second splines 301 also share a second conductive strip 172, preferably, two second splines 301 share a second conductive strip 172; optionally, three, four or five The second splines 301 share a second conductive bar 172 . Exemplarily, when the second basket 300 is provided with ten second splines 301 , the number of second conductive strips 172 may be five.

Both the first conductive strip 171 and the second conductive strip 172 extend along the L-axis, the proximal end of the first conductive layer is connected to the control handle 800, and the distal end is connected to the first spline 201, and the first conductive strip 171 is provided with multiple conductive layers inside. , the multiple conductive layers are insulated from each other, and each conductive layer is connected to a first electrode 400, so that each first electrode 400 can be independently addressed.

Similarly, the proximal end of the second conductive layer is connected to the control handle 800, and the far end is connected to the second spline 301. The inside of the second conductive strip 172 is also provided with mutually insulated multi-layer conductive layers, and each layer of conductive layers is respectively connected to a second electrodes 500 so that each second electrode 500 can be addressed independently.

Further, the first conductive strip 171 is closer to the third conduit 130 than the second conductive strip 172, that is, in the compartment formed by the first conduit 110 and the third conduit 130, the second conductive strip 172 is located near the L-axis , the first conductive strip 171 is located away from the L-axis, that is, the first conductive strip 171 is on the outer layer of the second conductive strip 172 .

3c, 5-10, a delivery lumen 111 is formed in the first catheter 110, and a guide wire that can be extended and retracted from the distal end of the first catheter 110 can be provided. The first catheter 110 penetrates the guide head 600 and extends to The distal surface of the guide head 600. In fact, the delivery chamber 111 can deliver various liquids, such as physiological saline, contrast agent, etc., in addition to the guide wire. When it is necessary to infuse heparin saline to prevent thrombus formation, the distal part of the first catheter 110 can also be designed as a blind end, and the exposed part at the junction of the distal end and the proximal end of the second basket 300 has a wall hole, extending Tubes, etc., perfuse heparin saline through holes and tubes; or set a perfusion tube 113 parallel to the first catheter 110 on the catheter assembly 100, and perfuse heparin saline through the perfusion tube 113. The perfusion of heparin saline can effectively prevent tissue blood coagulation so that the device can work more safely.

Preferably, the first conduit 110, the second conduit 120, and the third conduit 130 are arranged coaxially, all extending along the L axis, and the first conduit 110, the second conduit 120, and the third conduit 130 are flexible, that is, is bendable. The first conduit 110, the second conduit 120, and the third conduit 130 are all constructed of polyurethane or PEBAX (polyether block amide), and the third conduit 130 on the outermost side can also be provided with an embedded braided mesh such as stainless steel. To increase the torsional stiffness of the catheter assembly 100 itself, so that when the control handle 800 is rotated, the distal end of the catheter assembly 100 itself will rotate in a corresponding manner.

In this implementation, the wall thicknesses of the first conduit 110, the second conduit 120, and the third conduit 130 are roughly as follows, the wall thickness of the first conduit 110, the second conduit 120 is 0.10mm; the third conduit 130 plays a supporting role, and the wall The thickness is set to 0.20mm.

Referring to FIG. 5 , the connecting sleeve 700 is in the shape of a sleeve, and the connecting sleeve 700 is directly nested to the outer wall of the connecting portion 141 and fused together. The diameter of the outer ring of the connecting sleeve 700 is the same as that of the third conduit 130 ; thus, the outer wall of the connecting sleeve 700 fits the outer wall of the third conduit 130 .

Referring to FIGS. 6a-6c , the guide head 600 connects the distal ends of the first basket 200 and the second basket 300 , and the guide head 600 is connected with the distal end of the first catheter 110 . Through the first conduit 110, the deployment of the first basket 200 and the second basket 300 can be controlled; when the first conduit 110 is retracted, the first basket 200 and the second basket 300 are simultaneously deployed; When the catheter 110 is stretched out, the first basket 200 and the second basket 300 contract simultaneously.

Referring to Figs. 6a-6c, the guide head 600 can optionally adopt a traditional cap shape. The following structure can also be adopted. The guide head 600 includes a connector 601 and a fastener 602. The distal ends of the first basket 200 and the second basket 300 are respectively inserted into the holes of the connector 601 from the far and near ends of the connector 601. The fastener 602 The distal end of the connector 601 is installed in the shape of a rivet, and the distal surface of the fastener 602 is disposed in a hole communicating with the first catheter 110 , and the distal surface of the fastener 602 is an arc surface. In the unfolded state of the device, the distal surface of the fastener 602 does not protrude from the distal surface of the first basket 200; preferably in this embodiment, the distal surface of the first basket 200 and the distal end of the fastener 602 face overlap. It can ensure that the introduction end (that is, the distal end) of the device remains smooth, and when the device is introduced into a human patient's tissue, trauma to the human body is reduced.

In some other embodiments, the distal end surface of the guide head 600 may also slightly protrude from the distal end surface of the first basket 200 in the unfolded state, and the protruding distance is less than 2mm.

As shown in Figure 6a, the distal end of the first spline 201 is inserted into the inside of the connector 601 from the distal end of the guide head 600; the distal end of the second spline 301 is inserted into the inside of the connector 601 from the proximal end of the guide head 600 . The part of the first spline 201 inserted into the connector 601 is perpendicular to the axis L of the catheter assembly 100; the part of the second spline 301 inserted into the guide head 600 is parallel to the axis L of the catheter assembly 100, that is, the first spline 201 The insertion portion of the spline and the insertion portion of the second spline 301 are perpendicular to each other.

Optionally, as shown in FIG. 6b, the part where the first spline 201 is inserted into the connector 601 is on the same plane as the part where the second spline 301 is inserted into the connector 601. Specifically, the first spline 201 After being inserted from the distal end of the guide head 600, the insertion part is bent proximally to fit the inner wall of the connector 601, and the insertion part of the second spline 301 is bent toward the distal end after being inserted from the proximal end of the guide head 600. Fit the inner wall of the connecting piece 601 so that the first spline 201 and the second spline 301 are in the same plane (the plane of the inner wall of the connecting piece 601 ).

Optionally, as shown in FIG. 6 c , at least a part of the part where the first spline 201 is inserted into the connector 601 and the part where the second spline 301 is inserted into the connector 601 overlap each other. Specifically, the insertion part of the second spline 301 is inserted from the proximal end of the guide head 600 and bent toward the distal end until it fits the inner wall of the connector 601, and the insertion part of the first spline 201 is inserted from the distal end of the guide head 600. After being inserted, it is bent toward the proximal end until it fits on the inner wall of the insertion portion of the second spline 301 , and the insertion portions of the two splines overlap each other. It is also possible that the insertion part of the first spline 201 is bent to fit the inner wall of the connector 601 , and the insertion part of the second spline 301 is bent and fitted to the inner wall of the first spline 201 .

3a-3f, in this embodiment, the first electrode 400 of the first basket 200 located on the outer layer is configured as contact mapping, the first electrode 400 is embedded on the outer surface of the first spline 201, a first The spline 201 is provided with a plurality of first electrodes 400, and the plurality of first electrodes 400 on a first spline 201 are uniformly arranged along the L axis, and the density of the first electrodes 400 arranged on the first basket 200 is relatively low. High (a basket with more than 20 electrodes in the field can be characterized as a "high-density" electrode basket), the surface area of the first electrode 400 is small, and its width is smaller than the width of the first spline 201. The first basket 200 on the outer layer is provided with 6-20 strands of first splines 201 , preferably 10 strands; 2-100 first electrodes 400 can be arranged on each strand of first splines 201 .

Further, the inner surface of the first spline 201 may also be provided with a first electrode 400, and the first electrode 400 located on the inner surface may be configured for non-contact mapping.

3a-3f, in this embodiment, the second electrode 500 of the second basket 300 located in the inner layer is configured as non-contact mapping, the second electrode 500 is embedded on the outer surface of the second spline 301, and a first Two splines 301 are provided with a plurality of second electrodes 500, and a plurality of second electrodes 500 on a second spline 301 are evenly arranged along the L axis, and the density of the second electrodes 500 arranged on the second basket 300 is relatively high. Higher, the second electrode 500 has a larger surface area, and its width can be set to be greater than the width of the second spline 301, which can improve the sensitivity of the collected signal. The second basket 300 in the inner layer is preferably provided with 6-20 strands of second splines 301 , preferably 10 strands; 2-100 second electrodes 500 can be arranged on each second spline 301 .

In this embodiment, the arrangement of the electrodes is preferentially uniform. In the unfolded state of the device, the distance between the center points of two adjacent electrodes on the same spline is 0.5-5 mm; preferably 1.7 mm. The shape of the electrode can be sheet, ring, flower or other shapes. The number of upper first electrodes 400 of the first basket 200 is 100-200, preferably 120; the number of upper second electrodes 500 of the second basket 300 is 50-100, preferably 80.

In other embodiments, the relationship between the first electrodes 400 and the second electrodes 500 at the corresponding positions of the inner and outer layers may be cross distribution, overlapping distribution, or partial overlapping and partial crossing.

In other embodiments, regarding the size relationship between the first electrode 400 and the second electrode 500 of the inner and outer layers, they may be electrodes of the same size, or the outer layer may be a large electrode, and the inner layer may be a small electrode, or the inner layer may be The outer layer is a large electrode, the outer layer is a small electrode, and so on.

Preferably, both the first electrode 400 and the second electrode 500 are in the form of sheets, which are constructed of ductile and soft metals, such as gold and silver.

Combined with Figure 11-12, the manufacturing method of the net basket in this device is to use 3D printing technology, specifically:

S1. Print two sheets of spline arrays containing electrodes respectively, and the proximal ends of the splines are connected by connecting parts.

S2.1. In the first basket 200 located on the outer layer, the proximal parts of several first splines 201 are provided with first connecting parts 701, and each first spline 201 is provided with a plurality of first electrodes 400 , the two ends of the first connecting portion 701 are welded to form a circle.

S2.2. The second net basket located in the inner layer is also made in the same way. The proximal parts of several second splines 301 are provided with second connecting parts 702, and each second spline 301 is provided with a plurality of first splines. The two electrodes 500 are formed in a circular shape by welding both ends of the second connecting portion 702 .

S3 , nesting the second connection part 702 into the first connection part 701 , and welding the second connection part 702 and the first connection part 701 to form the connection sleeve 700 .

S4. Use the guide head 600 to connect the distal ends of the first spline 201 and the second spline 301, as shown in Figures 6a-6c.

Referring to FIG. 23 and FIG. 29 , the control handle 800 includes a handle body, a deployment adjustment component, a bending adjustment component, a guide wire inlet component and an electrical connector. The expansion adjustment component, the bending adjustment component, the guide wire control component, and the electrical connector are all arranged in the handle body, and the proximal ends of the second conduit 120 and the third conduit 130 are installed at the distal end of the handle body. The expansion adjustment assembly is connected to the proximal end of the first catheter 110, the bending adjustment assembly is connected to the proximal end of the pull wire 142, the lumen of the first catheter 110 is connected to the guide wire inlet assembly, and the conductive wire is electrically connected to the electrical connector.

In this embodiment, the working end of the device is delivered to the patient's tissue, and the first basket 200 and the second basket 300 are deployed to treat the patient's tissue. The first electrode 400 of the first mesh basket 200 on the outer layer is in contact with the patient's tissue for contact mapping; since the first mesh basket 200 on the outer layer is unfolded, the second electrode 400 of the second mesh basket 300 on the inner layer The 500 and the patient's tissue just form a certain distance, which can form a stable non-contact mapping.

In the past actual heart surgery with non-contact mapping, the mesh basket device is located in the heart tissue, and the mesh basket device performs mapping without contacting the heart tissue. However, as the heart beats and the atria contract, tissue tends to hit the surface of the device, causing a mechanical change in the shape of the basket and bringing the tissue into direct contact with the electrodes; Fluctuations will result in some incorrect data. Therefore, in this case, it is necessary to delete some signal data collected during systole according to past experience after the operation. Due to lack of experience or negligence, some important data will be deleted. However, in this device, the first mesh basket of the outer layer is used to expand, so that the second electrode 500 of the second mesh basket 300 of the inner layer forms a stable distance with the patient's tissue, so that the first mesh basket can be placed on the second electrode 500 of the second mesh basket. The basket 300 is protected to avoid impact on the second basket 300 in the inner layer when the heart beats, so that very stable non-contact mapping can be performed, so the mapping data is also stable, and there is no need to modify the mapping data. group to filter.

Moreover, the above is to map the patient's tissue through the combination of the two mapping methods, so as to obtain a mapping result with higher accuracy.

Embodiment two

This embodiment is substantially the same as the above-mentioned embodiment, the difference is that it also includes a magnetic sensor 901 and a central reference electrode 902, specifically as follows:

Referring to FIG. 13 , a magnetic sensor 901 is provided near the distal end of the first catheter 110 , and the magnetic sensor 901 can be sleeved outside the first catheter 110 , or the magnetic sensor 901 can be wrapped in the first catheter 110 . The magnetic sensor 901 is disposed in the second basket 300 , specifically, the magnetic sensor 901 is located at a remote position in the second basket 300 . The catheter assembly 100 is provided with conductive wires that are independently connected to the magnetic sensor 901 and can be individually addressed.

Referring to FIG. 13 , the magnetic sensor 901 at the distal end of the first catheter 110 is inlaid with a central reference electrode 902 on the surface. The central reference electrode 902 serves as a reference for other electrodes and can assist other electrodes to record the electrical activity of the heart. The central reference electrode 902 is also connected to an independent The conductive lines or conductive layers can be independently addressed. Specifically, when the first electrode 400 performs contact mapping, the first electrode 400 can be configured as a positive electrode, and the central reference electrode 902 can be configured as a ground, and the electrical signal between the first electrode 400 and the central reference electrode 902 can be recorded. A monopolar electrogram is recorded, which, unlike a bipolar electrogram recorded between two first electrodes 400, can provide information on the electrical activity of the heart as it approaches or moves away from the electrodes. Of course, during mapping, the first electrode 400 can also be set as the negative pole, and the central reference electrode 902 can still be set as the ground, and a monopolar electrogram can also be recorded. Similarly, when the second electrode 500 performs non-contact mapping, the second electrode 500 can be configured as a positive pole or a negative pole, the central reference electrode 902 can be configured as a ground, and the voltage between the second electrode 500 and the central reference electrode 902 can be recorded. signal, recorded onto a monopolar electrogram.

In some other implementation manners, the central reference electrode 902 may not be arranged on the surface of the magnetic sensor 901 , but may be arranged on the first catheter 110 and near the magnetic sensor 901 .

Further, installing the magnetic sensor 901 on the basket catheter can locate and track the double-layer basket catheter device in the body. In the prior art, when medical personnel operate catheters, they can generally be observed by X-rays. However, X-rays radiate medical personnel, which increases the risk of cancer replacement for medical personnel. In this embodiment, it is proposed to use magnetic sensors to assist positioning, which can reduce the number of operations. The amount of X-rays used for the operation.

Electric field navigation is to apply a near-orthogonal patch on the surface of the patient, and the patch emits an excitation current of a certain frequency. By calculating the change in the resistance between the central reference electrode 902 and the patch, the operation of the double-layer basket catheter device can be obtained. end location information. The accuracy of electric field positioning is easily affected by the human body. The electrical impedance of the human body is greatly affected by breathing and sweat on the body surface, and the coordinate system established by this impedance will be spatially distorted. Therefore, it is necessary to establish a magnetic field coordinate system at the same time to calibrate the position information of the electric field positioning.

Based on a specific algorithm, the position information of the central reference electrode 902 and the position information of the magnetic sensor 901 can be fused to realize navigation and positioning of the catheter by magnetoelectric fusion. Specifically, at the same position in the heart cavity, the device can simultaneously collect the electrical channel data (x, y, z coordinate parameters) of the central reference electrode 902 and the magnetic channel data (x, y, z coordinate parameters) of the magnetic sensor 901, and then combine the two When the catheter moves fully in the heart chamber and collects enough coordinates, any electrode on the catheter can find the corresponding magnetic channel data (coordinate information) in this space. The data of one channel (electrode) at a certain spatial position can infer the data of another channel (electrode) at that spatial position.

The basic idea of the algorithm is:

Table building process: According to the existing standard magnetoelectric data pairs, a multi-level index table of magnetoelectric data pairs corresponding to three-dimensional space positions is established. Specifically, move the catheter fully in the heart cavity, collect the electrical channel data of the central reference electrode 902 and the magnetic channel data of the magnetic sensor 901 at each position, and then make a one-to-one correspondence between the two to establish an index table, that is, establish a magnetoelectric channel data. Combined spatial coordinate system.

Table lookup process: After collecting data from any electrode channel on the catheter, look for the magnetic channel data corresponding to the electrical channel data in the multi-level index table through the electrical channel data. The magnetic field coordinate system is uniform and accurate in space, so through the electrical channel data -The spatial position obtained by the corresponding relation of the magnetic space is also accurate, so as to realize the precise navigation of the catheter.

Embodiment three

This embodiment is substantially the same as the above-mentioned embodiment, and its difference lies in the structure of the second net basket 300, specifically as follows:

Referring to FIGS. 14-15 , the second basket 300 includes a balloon 302 and several second splines 301 arrayed on the inner surface of the cavity of the balloon 302 . The setting structure of the second electrode 500 is the same as the previous embodiment, the second electrode 500 is inlaid on the outer surface of the second spline 301 ; the balloon 302 is provided with several openings corresponding to the second electrode 500 to expose the second electrode 500 .

14-15, the distal end of the balloon body of the balloon 302 is welded to the guide head 600, and the proximal end of the balloon body of the balloon 302 is sleeved on the connecting part 141, and it is welded; the second catheter 120, the second The compartment between the conduits 110 forms a pressure delivery chamber, the first conduit 110 and the second conduit 120 directly penetrate the lumen of the connecting part 141, the pressure delivery chamber communicates with the cavity of the balloon 302, and the pressure medium can directly pass through The pressure delivery cavity enters the cavity of the balloon 302 .

Referring to FIG. 15 , the pressure medium (generally developer) is input into the pressure delivery chamber, and the pressure medium directly enters the cavity of the balloon 302 through the pressure delivery chamber, thereby inflating the balloon 302 and deploying the second basket 300 .

Embodiment four

This embodiment is substantially the same as the above-mentioned embodiment, the difference lies in the structure of the catheter assembly 100, specifically as follows:

Referring to Figures 16-17, the catheter assembly 100 extends along the L-axis as a whole and includes the following components:

The third conduit 130 is located on the second outer side;

The second conduit 120, the second conduit 120 is sleeved in the third conduit 130;

The stress sleeve 160 is sleeved outside the third conduit 130 , and the stress sleeve 160 is detachably matched with the first basket 200 and the second basket 300 .

The bendable member includes a connection part 141 and two symmetrically distributed pull wires 142, the pull wire 142 is covered with a protective sheath, the proximal end of the connection part 141 is inserted into the distal end of the third catheter 130, and the pull wire 142 is arranged on the third catheter 130, the third catheter 130 In the compartment between the two catheters 120 , the distal end of the pull wire 142 is connected to the proximal end of the connection part 141 , and the bendable member can be controlled to bend in the direction of the pull wire 142 by pulling a certain pull wire 142 .

16-17, the proximal end of the first basket 200 is not connected to the connecting portion 141, the proximal end is free, the proximal end of the second basket 300 is connected to the connecting portion 141, and the proximal end of the second basket 300 is set Connecting sleeve 700 is arranged, and connecting sleeve 700 is set on connecting portion 141; The head 600 and the guide head 600 are independent. The expansion of the first basket 200 and the second basket 300 can be controlled through the stress sleeve 160; when the stress sleeve 160 is retracted, the first basket 200 and the second basket 300 are simultaneously deployed.

Specifically, when the distal end of the catheter device is wrapped with the stress sleeve 160, the first basket 200 and the second basket 300 are in a contracted state.

When the distal end of the catheter device reaches the patient's tissue, as shown in FIG. The basket 200 and the second net basket 300 perform elastic recovery, so as to realize deployment.

When the catheter device needs to be recovered, it is only necessary to retract the catheter device as a whole. At this time, the first basket 200 and the second basket 300 themselves will perform elastic deformation and contraction according to the environment of the patient's tissue; The first spline 201 of the first basket 200 will be reversed in the distal direction, and the second basket 300 located on the inside will contract as a whole, so as to follow the pipeline and leave the patient's tissue.

Of course, the stress sleeve can also be applied to the "structure in which the proximal end of the first basket 200 and the proximal end of the second basket 300 are connected", specifically:

Referring to FIG. 18 , the catheter assembly 100 is as described above without the first catheter 110 . The proximal end of the first net basket 200 and the proximal end of the second net basket 300 are connected with the connection part 141, and the proximal ends of the first net basket 200 and the second net basket 300 are provided with a connecting sleeve 700, and the connecting sleeve 700 is set on the connection On the part 141; the far ends of the first net basket 200 and the second net basket 300 are connected, the far ends of the first net basket 200 and the second net basket 300 are provided with a guide head 600, and the guide head 600 is independent. The expansion of the first basket 200 and the second basket 300 can be controlled through the stress sleeve 160; when the stress sleeve 160 is retracted, the first basket 200 and the second basket 300 are simultaneously deployed.

Embodiment five

This embodiment is substantially the same as the above-mentioned embodiments, the difference lies in the structure of the first basket 200; details are as follows.

17-18, the first basket 200 includes a number of first splines 201 uniformly arranged in the circumferential direction of the catheter assembly 100 axis, the first splines 201 extend along the L axis, and the first electrode 400 is arranged on the first spline. On the key 201 ; the distal ends of the first basket 200 and the second basket 300 are provided with guide heads 600 , and the guide heads 600 are connected with the distal ends of the first catheter 110 .

However, the proximal ends of the first net basket 200 and the second net basket 300 are not connected, and the connecting sleeve 700 only sets the proximal end of the second net basket 300 and is sleeved on the connecting portion 141. The proximal ends of the splines 201 are relatively independent. The first splines 201 are more than two-thirds of a semicircular arc shape, and the "umbrella shape" or a part of the "umbrella shape" is formed between several first splines 201.

The catheter assembly 100 of this embodiment is substantially the same as that of the eighth embodiment.

Embodiment six

This embodiment is substantially the same as the above-mentioned embodiment, the difference lies in the structure of the first basket 200, the second basket 300, and the structure of the guide head 600 at the distal end; the details are as follows.

Referring to FIG. 19 , the first spline 201 and the second spline 301 are integrally structured (hereinafter referred to as splines), several splines are connected end to end at the distal end of the catheter assembly 100, the guide head 600 is annular, and the guide head 600 The distal ends of several splines are connected in series, and the first catheter 110 is connected with the annular guide head 600; the part with some splines on the inside forms the second basket 300, and the part with some splines on the outside forms the first basket 200 . A buckle 603 is provided at the distal end of the guide head 600 , and a proximal end of the buckle 603 is connected with the first catheter 110 .

Embodiment seven

This embodiment is substantially the same as the above-mentioned embodiment, the difference lies in the distribution structure of the second electrodes 500 on the second basket 300, which is as follows.

Referring to FIGS. 20-21 , two adjacent second electrodes 500 along the rotation direction of the axis of the catheter assembly 100 are distributed forward and backward along the L-axis direction. When the second basket 300 is in the contracted state, the second electrodes 500 are dislocated and distributed, which can reduce the overall volume in the contracted state. This structure is applicable regardless of whether the second basket 300 is mesh-shaped, balloon-shaped, or spline-shaped.

As shown in FIG. 21 , when the second basket is collapsed into the collapsed configuration, the electrodes are configured to nest with adjacent electrodes along the direction of rotation of the catheter assembly 100 axis.

It can ensure the maximum quantity of each electrode, and can reduce the overall volume of the mesh basket in a contracted state. In this embodiment, the second electrode 500 is in the shape of a regular hexagon, and in other embodiments, it may be in the shape of a prism, a rectangle or other shapes.

Embodiment eight

This embodiment is substantially the same as the above-mentioned embodiment, the difference lies in the shape of the net basket after opening, as follows.

Combined with Figures 22-23, in this embodiment, as shown in Figure 23, when the basket is fully expanded, it is "pear-shaped" with a large distal end and a small proximal end; Relatively uniform end-to-proximal. After the net basket is unfolded, the maximum diameter of the net basket is 16-28 mm, preferably 20 mm in diameter.

The mesh basket with the above shape can facilitate the working end of the device to abut against the myocardium laterally, thereby optimizing the treatment.

Embodiment nine

This embodiment is substantially the same as the above-mentioned embodiment, and the difference is that a perfusion structure is added, as follows.

Referring to FIG. 24 , the distal end of the first catheter 110 is closed, and a perfusion hole 112 is opened on the side wall of the distal portion of the first catheter 110 , and heparin saline is perfused into the tissue through the perfusion hole 112 .

Or, in conjunction with Fig. 3c, the distal end of the first conduit 110 is closed, and a perfusion tube 113 is added on the sidewall of the distal portion of the first conduit 110, and the perfusion tube 113 communicates with the delivery chamber 111 of the first conduit 110, and the perfusion tube The end of 113 is closed, and a perfusion hole is opened on the side wall of the perfusion tube 113, through which heparin saline is perfused to the tissue. The perfusion tube 113 is located at the proximal end of the first catheter 110 near the second basket 300 , and prevents blood from coagulating at the junction of the splines by perfusing heparin saline.

Or, in conjunction with FIG. 26 , it is easy to see, so the first basket 200 and the second basket 300 are hidden; without changing the structure of the first catheter 110, an additional perfusion tube 113 is added in the catheter assembly 100, and the perfusion tube 113 The distal end is closed, and the perfusion tube 113 is arranged parallel to and side by side with the first catheter 110 , and a perfusion hole 112 is opened on the perfusion tube 113 , and the tissue is perfused with heparin saline through the perfusion hole 112 .

Perfusing the heparin saline into the tissue through the above structure can prevent blood coagulation during the treatment process and improve the treatment effect.

Embodiment ten

This embodiment is substantially the same as the above embodiment, the difference lies in the number of baskets, as follows.

27-29, it also includes a third basket 1000 and several third electrodes 1100, the third basket 1000 is arranged at the distal end of the catheter assembly 100, and several third electrodes 1100 are arranged on the surface of the third basket 1000 .

The near ends of the first net basket 200, the second net basket 300, and the third net basket 1000 are connected, and the near ends of the first net basket 200, the second net basket 300, and the third net basket 1000 are provided with a connecting sleeve 700, essentially On the above, the connecting sleeve 700 is the medium for connecting objects with three baskets; the connecting sleeve 700 is set on the connecting part 141;

The far-ends of the first net basket 200, the second net basket 300, and the third net basket 1000 are connected, and the far-ends of the first net basket 200, the second net basket 300, and the third net basket 1000 are provided with a guide head 600. Above, the guide head 600 is an object medium connected by three baskets, and the guide head 600 is connected with the distal end of the first catheter 110 .

Therefore, through the first conduit 110, the expansion/contraction of the first basket 200, the second basket 300, and the third basket 1000 can be controlled; when the first conduit 110 is retracted, the first basket 200, the second basket The second basket 300 and the third basket 1000 are deployed simultaneously; when the first conduit 110 is extended, the first basket 200 , the second basket 300 and the third basket 1000 are contracted simultaneously.

In the circumferential direction, the third electrodes 1100 are interspersed between two adjacent first electrodes 400 and are staggered from the second electrodes 400 . That is, in the direction perpendicular to the L axis, arranged along the circumferential direction, the arrangement sequence of the first electrode 400, the second electrode 500, and the third electrode 1100 is: the first electrode 400, the second electrode 500, the third electrode 1100, the An electrode 400 , a second electrode 500 , a third electrode 1100 . . .

The treatment is carried out through the three-layer mesh basket, which can further improve the one-time treatment effect by combining a variety of electrodes with different properties. In other embodiments, four layers, five layers, six layers, etc. can also be set.

Embodiment Eleven

This embodiment is substantially the same as the above-mentioned embodiment, and the difference lies in the properties of the electrodes, which are as follows.

In this embodiment, the properties of the electrodes are the same, that is, the functions of the electrodes are the same. Taking the double-layer basket structure as an example, the first electrode 400 on the outer layer is a non-contact mapping electrode, and the second electrode 500 on the inner layer is also a non-contact mapping electrode.

During the working process of the device: the working end of the device is transported to the patient's tissue, and the first basket 200 and the second basket 300 are unfolded to perform non-contact mapping on the patient's tissue; During the mapping process, the density of the electrodes is high, and the quality of the collected signals is correspondingly improved.

It should be noted that cross-correlation (referring to the cross-correlation between the measured signal and the real ECG signal) and absolute time delay (referring to the time delay between the measured signal and the real signal) are judgment indexes in this field. The higher the cross-correlation, the better the mapping effect; the lower the absolute delay, the better the mapping effect.

In the past, increasing the electrode density was to carry out high-density electrode arrangement on the spherical surface of a single net basket, which is undoubtedly the area density; and the present invention increases the density of the electrodes in the sense of space, which is a three-dimensional density; the net basket device of the present invention , which can improve the cross-correlation property of the mapping signal, reduce the absolute time delay of the mapping signal, and reduce the distortion of the mapping signal.

Combined with Figure 30, compare the single-layer mesh basket with 200 electrodes and the double-layer mesh basket with 200 electrodes (80 electrodes in the inner layer and 120 electrodes in the outer layer). Schematic diagram of cross-correlation and absolute delay comparison of signals. Then, the T test was used for statistical analysis, and it was found that the mesh basket with 200 electrodes in double layers had a better mapping effect than that with 200 electrodes in a single layer, and there was a significant difference (p<0.005). Under the same number of electrodes, the basket device of the present invention forms a three-dimensional high-density structure in such a way that the electrodes are distributed inside and outside. Compared with the surface density of a single-layer net basket, the cross-correlation properties of its mapping signals are higher, and the mapping The absolute delay of the signal is lower.

Moreover, some studies have shown that in the mapping operation in the low-density electrode basket, inaccurate target positioning usually occurs, and the recurrence rate of patients after surgery is high, which may cause patients to need secondary surgery; the resulting Yes, the cost of surgery will increase, and it will bring certain surgical risks. The high-density electrode mesh basket device has excellent performance in mapping surgery, using ultra-high-density markers, accurate target positioning, good marking effect, low recurrence rate after surgery, avoiding secondary surgery; can reduce risk and reduce the financial burden on patients.

In an electrode basket, the higher the electrode density, the higher the cross-correlation properties and the lower the absolute time delay. Under the same volume of the basket device, the basket device of the present invention can achieve higher density. Alternatively, it can be considered that when it is necessary to design a basket device with a certain number of electrodes, the present invention makes the electrode density a real space density by distributing electrodes inside and outside, so that the volume of the basket device can be made smaller, and it can better enter human patients. organize.

In the description of the present invention, unless otherwise clearly specified and limited, the terms "first", "second", and "third" are only used for the purpose of description, and cannot be understood as indicating or implying relative importance; unless As otherwise specified or explained, the term "plurality" refers to two or more; the terms "connection" and "fixation" should be understood in a broad sense, for example, "connection" can be a fixed connection or a detachable connection. Connected, or integrally connected, or electrically connected; it can be directly connected or indirectly connected through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

In the description of this specification, it should be understood that the orientation words such as "front", "rear", "upper", "lower", "inner" and "outer" described in the embodiments of the present invention are as shown in the accompanying drawings. The description is made from the perspective of the present invention and should not be construed as a limitation to the embodiments of the present invention. In addition, in this context, it also needs to be understood that when it is mentioned that an element is connected "before" or "behind" another element, it can not only be directly connected "before" or "behind" another element, but can also be To be indirectly connected "before" or "after" another element through an intervening element.

What have been described above are only some embodiments of the present invention. For those skilled in the art, without departing from the inventive concept of the present invention, several modifications and improvements can be made, and these all belong to the protection scope of the present invention.

Claims

The double-layer basket catheter device is characterized in that it comprises:

catheter assembly;

guide head;

The first basket, one end is connected to the distal end of the catheter assembly, and the other end is connected through a guide head, and a plurality of first electrode bands from the far end to the proximal end of the first basket are evenly distributed on the first basket, and the first electrodes are the strip includes a plurality of first electrodes;

The second basket, one end is connected to the far end of the catheter assembly, and the other end is connected by a guide head, a plurality of second electrode bands from the far end to the proximal end of the second basket are evenly distributed on the second basket, and the second The electrode strip includes a plurality of second electrodes;

The first net basket and the second net basket can be expanded or contracted synchronously through the operation of the guide head;

In the expanded state, the first net basket and the second net basket are deformed, and the second net basket is inside the first net basket.
The double-layer basket catheter device according to claim 1, wherein the first basket comprises a plurality of evenly arranged elongated deformable first splines, each first spline is provided with A plurality of first electrodes form a first electrode belt; the second basket includes a plurality of evenly arranged elongated deformable second splines, and each second spline is provided with a plurality of second electrodes to form a first electrode belt. Two electrode belts; the distal ends of multiple first splines and multiple second splines are connected to the guide head; the proximal ends of multiple first splines and multiple second splines are connected to the distal end of the catheter assembly.
The double-layer basket catheter device according to claim 2, wherein each second spline in the second basket is opposite to a first spline in the first basket; or, the Each second spline in the second basket is opposite a gap between two adjacent first splines in the first basket.
The double-layer basket conduit device of claim 2, the number of said first splines is the same as or different from the number of said second splines.
According to the double-layer basket catheter device according to claim 1, the number of the first electrodes is the same as or different from the number and spacing of the second electrodes.
The double-layer mesh basket catheter device according to claim 1, characterized in that, in two adjacent second electrode strips, the second electrodes are dislocated or parallel distributed.
The double-layer basket catheter device according to any one of claims 1-6, wherein the catheter assembly includes a telescopic first catheter, the first catheter is connected to the guide head, and the first catheter is operated by telescopic operation. To control the guide head connected to it, so as to expand or contract the first basket and the second basket.
The double-layer basket catheter device according to any one of claims 1-6, wherein the double-layer basket catheter is a nested structure, and the diameter of the second basket is always smaller than that of the first basket at different degrees of expansion. .
The double-layer basket catheter device according to any one of claims 1-6, wherein the diameter of the proximal fixing point of the second basket is smaller than the diameter of the proximal fixing point of the first basket.
The double-layer basket catheter device according to claims 1-6, wherein the catheter assembly is provided with a bendable member for enabling the first basket and the second basket to move toward at least the axis of the catheter assembly. 1 direction bending 70°-270°.
The double-layer basket catheter device according to any one of claims 1-6, wherein the distal ends of the first basket and the second basket are connected through a guide head; the guide head is connected with the second basket The distal end of a catheter is connected.
The double-layer basket catheter device according to any one of claims 2-5, wherein the proximal ends of the first spline and the second spline form a connecting sleeve and are connected to the distal end of the catheter assembly.
The double-layer basket catheter device according to claim 11, wherein the distal end surface of the guide head does not protrude from the distal end surface of the first basket in the deployed state, or,

The distance from the distal end surface of the guide head protruding from the distal end surface of the first basket in the unfolded state is less than 2mm.
The double-layer basket catheter device according to any one of claims 1-6, 13, characterized in that, the guide head has a hollow cavity, and the hollow cavity is docked with the first catheter, allowing the guide wire to be delivered from the control handle end. The wire passes through the distal end of the guide head.
The double-layer basket catheter device according to claim 13, wherein the distal end of the first spline is inserted into the interior of the guide head from the distal end of the guide head; A distal end is inserted into the interior of the guide head from the proximal end of the guide head.
The double-layer basket catheter device according to claim 15, wherein the part of the first spline inserted into the guide head is perpendicular to the axis of the catheter assembly; the second spline inserted into the The portion inside the guide head is parallel to the axis of the catheter assembly.
The double-layer basket catheter device according to claim 15, wherein the part where the first spline is inserted into the guide head and the part where the second spline is inserted into the guide head are in the same position. The same plane or at least partially superimposed.
The double-layer basket catheter device according to any one of claims 1-6, wherein the first electrode is configured as an electrode that realizes contact mapping and/or non-contact mapping; the second electrode Electrodes configured to enable non-contact mapping.
The double-layer basket catheter device of claim 2, wherein the first basket includes at least six first splines; and the second basket includes at least six second splines.
The double-layer basket conduit device according to claim 19, wherein the number of the first splines is six, eight, ten or twelve; the number of the second splines is six or eight , ten or twelve.
The double-layer basket catheter device according to claim 20, wherein at least six first electrodes are provided on each of the first splines; at least six electrodes are provided on each of the second splines. second electrode.
The double-deck basket conduit device of claim 21, wherein:

Twelve first electrodes are provided on each of the first splines,

eight second electrodes are provided on each of said second splines; or,

Twenty first electrodes are provided on each of the first splines,

Each of the second splines is provided with eight second electrodes.
The double-layer basket catheter device according to any one of claims 19-22, characterized in that the interval between two adjacent first electrodes (400) on the same first spline (201) is 0.5- 5mm;

The interval between two adjacent second electrodes (500) on the same second spline (301) is 0.5-5mm.
The double-layer basket catheter device according to claim 7, wherein a central reference electrode is provided near the distal end of the first catheter for assisting the first electrode and/or the second electrode to record the heart electrical activity.
The double-layer basket catheter device according to claim 24, wherein when the first electrode performs mapping, the first electrode is configured as a positive pole or a negative pole, and the central reference electrode is configured as a ground , recording the electrical signal between the first electrode and the central reference electrode to obtain a monopolar electrogram; and/or,

When the second electrode is used for mapping, the second electrode is configured as positive or negative, and the central reference electrode is configured as ground, and the electrical signal between the second electrode and the central reference electrode is recorded to obtain a unipolar voltage. picture.
The double-layer basket catheter device according to claim 25, wherein a magnetic sensor is provided near the distal end of the first catheter, which can be used to locate and track the double-layer basket catheter device.
The double-layer basket catheter device according to claim 26, wherein the position of the double-layer basket catheter device is obtained by collecting the magnetic channel data of the magnetic sensor and/or the electrical channel data of the central reference electrode information.
The double-layer basket catheter device according to claim 1, characterized in that, the first basket comprises a self-responsive mesh member woven by several skeletons intersecting, and the first electrode is installed on the skeleton and distributed along the surface contour of the mesh member.
The double-layer basket catheter device according to claim 1, wherein the second basket comprises a balloon and a plurality of second splines uniformly arranged in the circumferential direction, and the plurality of second splines are arranged on the capsule of the balloon. On the inner surface of the cavity; the second electrode is arranged on the second spline; the balloon is provided with several openings corresponding to the positions of the second electrodes.
The double-layer basket catheter device according to claim 1, wherein the second basket includes a self-responsive mesh member woven by several skeletons intersecting; the second electrode is installed on the skeleton surface, and distributed along the surface contour of the mesh member.