CN116549021A

CN116549021A - Ultrasonic double-layer basket catheter

Info

Publication number: CN116549021A
Application number: CN202210109576.6A
Authority: CN
Inventors: 冯君; 黄龙; 磨志岱; 李龙; 王本琪
Original assignee: Xinhang Medical Technology Guangzhou Co ltd
Current assignee: Xinhang Medical Technology Guangzhou Co ltd
Priority date: 2022-01-28
Filing date: 2022-01-28
Publication date: 2023-08-08

Abstract

The invention discloses an ultrasonic double-layer basket catheter, which comprises: the ultrasonic catheter comprises a catheter assembly, a first basket and a second basket, wherein the first basket comprises a plurality of first splines, a plurality of first electrodes are distributed on each first spline, ultrasonic transducers are packaged in the first electrodes, and the first electrodes on two adjacent first splines are staggered; a plurality of second electrodes are distributed on the second basket; the first basket and the second basket can be synchronously unfolded or contracted by operating the catheter assembly; when the first basket and the second basket are in the unfolded state, the first basket and the second basket are deformed, and the second basket is completely positioned inside the first basket and has a certain distance from the first basket. The ultrasonic double-layer basket catheter can realize the functions of ultrasonic detection rapid modeling and non-contact mapping, solves the problem of impact interference of the non-contact mapping, and can accurately draw a structural model of a heart and draw a conductive chart of heart electrical activity so as to facilitate the establishment of various subsequent treatment schemes.

Description

Ultrasonic double-layer basket catheter

Technical Field

The invention relates to the technical field of catheters, in particular to an ultrasonic double-layer basket catheter.

Background

Intracardiac ultrasound (ICE) technology, which was first applied in 1980 and has been used for many years in the field of cardiac interventional therapy to date, is a mature technology that allows for a clearer view of structures and catheters within the heart cavity than transthoracic ultrasound. With the aid of ICE, the safety and effectiveness of these surgical procedures is improved: atrial septal puncture with complex anatomy; placing a atrial defect repair patch; placing a left auricle occluder; and judging the contact degree of the ablation catheter relative to the target point.

The ICE is typically packaged as a linear catheter with an ultrasound transducer mounted at the head end. In combination with the associated equipment, may be displayed as a 2D ultrasound map. Over the years, ICE catheters have become smaller and more precise in presentation quality. However, because of the nature of only one ultrasonic transducer, the displayed information is still a planar sectional view, and the synchronous scanning of the whole heart cavity cannot be performed.

With the advancement of ultrasonic transducer technology, the size of ultrasonic transducers has been greatly reduced, thereby promoting the development of ultrasonic basket electrodes. Basket electrodes with 48 ultrasonic transducers are arranged on the market at present, each ultrasonic transducer is arranged on a spline of a basket and can emit ultrasonic beams so as to scan the whole heart chamber, and a three-dimensional model of the heart chamber can be built by combining software. Meanwhile, electrodes for non-contact mapping of electrical activity in the heart chamber are also arranged between the ultrasonic transducers, and a three-dimensional excitation conduction diagram can be drawn by combining software.

Due to the size, the basket is inevitably contacted with the inner wall of the heart chamber, so that the mechanical impact of heart beating can cause interference on the non-contact mapping electrode to influence the accuracy of mapping results. The existing ultrasonic basket electrode can not solve the problem.

Disclosure of Invention

According to one aspect of the present invention there is provided an ultrasonic double layer basket catheter comprising:

a catheter assembly;

the first basket is arranged at the far end of the catheter assembly and comprises a plurality of first splines, a plurality of first electrodes are distributed on each first spline, ultrasonic transducers are packaged in the first electrodes, and the first electrodes on two adjacent first splines are staggered;

the second basket is arranged at the far end of the catheter assembly, and a plurality of second electrodes are distributed on the second basket;

the first basket and the second basket can be synchronously unfolded or contracted by operating the catheter assembly;

when the first basket and the second basket are in the unfolded state, the first basket and the second basket are deformed, and the second basket is completely positioned inside the first basket and has a certain distance from the first basket.

In some embodiments, the second basket includes a plurality of uniformly arranged elongated deformable second splines, each of the second splines having a plurality of the second electrodes disposed thereon.

In some embodiments, each of the second splines is opposite a gap between two adjacent first splines.

In some embodiments, one first electrode on any one first spline is located between two adjacent first electrodes on adjacent first splines.

In some embodiments, the ultrasound transducer within each of the first electrodes is configured to transmit and receive ultrasound energy, thereby enabling calculation of the distance between the ultrasound transducer and a site of an endocardial surface orthogonal to the ultrasound transducer.

In some embodiments, a plurality of the first electrodes are in contact with or non-contact with a body component, and a plurality of distance data are measured to construct a structural model of the heart chamber.

In some embodiments, the second electrode is configured as a non-contact mapping electrode for recording electrical activity signals of the heart.

In some embodiments, the electrical activity signal of the heart comprises one or more of current density, charge density, transmembrane potential, electric dipole density, local field potential, activation time, voltage, and repolarization time information.

In some embodiments, the catheter assembly comprises a telescoping first catheter having a distal end provided with a guide head for connecting the distal ends of the first basket and the second basket, the first catheter controlling the guide head connected thereto by telescoping operation so as to simultaneously expand or contract the first basket and the second basket.

In some embodiments, a central reference electrode is provided on the first catheter near the distal end for assisting the second electrode in recording the electrical activity of the heart.

In some embodiments, when the second electrode performs non-contact mapping, the second electrode is configured as a positive electrode or a negative electrode, the central reference electrode is configured as a ground, and recording an electrical signal between the second electrode and the central reference electrode results in a monopolar electrogram.

In some embodiments, a magnetic sensor is provided on the first catheter near the distal end to enable positioning and tracking of the ultrasonic double-layer basket catheter.

In some embodiments, position information of the dual layer basket ablation catheter is obtained by acquiring magnetic channel data of the magnetic sensor and/or electrical channel data of the central reference electrode.

In some embodiments, the first basket includes at least six first splines and 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 the second splines is six, eight, ten or twelve.

In some embodiments, twelve first electrodes are provided on each of the first splines, and eight second electrodes are provided on each of the second splines; or, twenty first electrodes are arranged on each first spline, and eight second electrodes are arranged on each second spline.

The invention has the beneficial effects that: according to the ultrasonic double-layer basket catheter, the first electrodes on the two adjacent first splines on the first basket are staggered, so that the distribution density of ultrasonic beams on the spherical surface of the basket catheter is higher, and a structural model of a heart chamber can be quickly constructed. Because the first basket of the outer layer is unfolded, the second electrode of the second basket of the inner layer and the patient tissue just form a certain distance, stable non-contact mapping can be formed, the interference problem of non-contact mapping electrode impact is solved, and the mapping result is more accurate and guaranteed.

Drawings

FIG. 1 is a schematic perspective view of an ultrasonic double-layer basket catheter in accordance with one or more embodiments of the present invention.

Fig. 2 is a schematic side view of the ultrasonic double-layer basket catheter of fig. 1.

Fig. 3a is a schematic front view of the ultrasonic double basket catheter of fig. 1 in an expanded state.

FIG. 3b is a schematic view of the ultrasound double basket catheter of FIG. 1 in a deployed state, in a cross-sectional state perpendicular to the L-axis.

FIG. 3c is a schematic view of the ultrasonic double basket catheter of FIG. 1 in a contracted state in a cross-sectional state perpendicular to the L-axis.

FIG. 3d is a schematic side view of the first spline and the second spline of the ultrasonic double-layer basket catheter of FIG. 1.

Fig. 3e is a schematic side view of the ultrasonic double-layer basket catheter of fig. 1 in a contracted state.

Fig. 4 is a schematic perspective view showing a cross-sectional state of the ultrasonic double-layer basket catheter shown in fig. 1.

Fig. 5 is an enlarged schematic view of the portion a in fig. 4.

Fig. 6a is an enlarged schematic view of an embodiment of the portion B of fig. 4.

Fig. 6B is an enlarged schematic view of an embodiment of the portion B of fig. 4.

Fig. 6c is an enlarged schematic view of an embodiment of the portion B of fig. 4.

Fig. 7 is a schematic perspective view of a cross-sectional view of a catheter assembly portion of the ultrasonic double-layer basket catheter of fig. 1.

Fig. 8 is an enlarged schematic view of a portion of fig. 7.

Fig. 9 is an enlarged schematic view of a portion of fig. 8.

FIG. 10 is a schematic cross-sectional view of a catheter assembly portion of the ultrasonic double-layer basket catheter of FIG. 1.

FIG. 11 is a schematic view of the fabrication of the basket portion of the ultrasonic dual-layer basket catheter of FIG. 1.

FIG. 12 is a schematic view of the fabrication of the basket portion of the ultrasonic dual-layer basket catheter of FIG. 1.

Fig. 13 is a schematic perspective view of one embodiment of an ultrasonic double-layer basket catheter of the present invention.

Fig. 14 is a schematic perspective view of an embodiment of an ultrasonic double-layer basket catheter of the present invention attached to a control handle.

Reference numerals in the drawings: 100-catheter assembly, 110-first catheter, 111-delivery lumen, 112-infusion port, 113-infusion tube, 120-second catheter, 130-third catheter, 140-bendable member, 141-connection, 142-pull wire, 150-guidewire, 171-first conductive strip, 172-second conductive strip, 200-first basket, 201-first spline, 300-second basket, 301-second spline, 400-first electrode, 500-second electrode, 600-lead, 601-connection, 602-fastener, 603-press buckle, 700-connection sleeve, 701-first connection, 702-second connection, 800-control handle, 901-magnetic sensor, 902-central reference electrode.

Detailed Description

The invention is described in further detail below with reference to the accompanying drawings.

Example 1

1-2 schematically illustrate an ultrasonic double-layer basket catheter according to one embodiment of the present invention having a proximal end and a distal end, comprising: catheter assembly 100, first basket 200, second basket 300, first electrodes 400, second electrodes 500, and guide head 600. For better illustration of the various components of this embodiment, the axis of catheter assembly 100 is designated as the L-axis in conjunction with FIG. 1, and the forward direction of the L-axis is the distal direction and the opposite direction is the proximal direction in conjunction with FIG. 1. The present catheter is described in further detail below in conjunction with the concept of the L-axis. The specific structure is as follows,

the catheter assembly 100, the proximal portion of which is connected to the control handle 800, controls the basket portion of the distal end of the present catheter with the control handle 800;

a first basket 200 disposed at a distal location of the catheter assembly 100;

the second basket 300 is arranged at the distal end position of the catheter assembly 100 and is positioned in the first basket 200, namely, 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, the second basket 300, and the distal ends of the first basket 200, the second basket 300 are commonly connected to the control deployment section of the catheter assembly 100. Specifically, referring to fig. 1-2, the proximal ends of the first basket 200 and the second basket 300 are connected, a connecting sleeve 700 for connecting the first basket 200 and the second basket 300 is provided at the proximal ends thereof, and the connecting sleeve 700 is sleeved on the connecting portion 141 for fixation; distal ends of the first basket 200 and the second basket 300 are connected, and distal ends of the first basket 200 and the second basket 300 are provided with a guide head 600 connecting the two.

Referring to fig. 1-3, the first basket 200 has first electrode strips extending from a distal end to a proximal end thereof uniformly distributed thereon, the first electrode strips being composed of a plurality of first electrodes 400 arranged in a regular pattern; the first electrode 400 has an ultrasonic transducer enclosed therein, the ultrasonic transducer being configured to transmit and receive ultrasonic energy; specifically, the ultrasonic transducer generally adopts a structure of a synthetic piezoelectric ceramic component, lead zirconate titanate (PZT), or the like, and when the thickness thereof expands under negative pressure or compresses under positive pressure, a surface charge of negative or positive polarity is generated. By changing the polarity of the applied voltage at a known frequency, the crystal expands and contracts, transmitting mechanical energy into the adjacent medium (creating an ultrasonic beam) at the same frequency. Thus, each ultrasound transducer element is operative in either an excitation mode to transmit ultrasound energy or a reception mode to receive ultrasound energy, the ultrasound transducer transmitting and receiving ultrasound energy enabling ultrasound detection within the heart, assisting in the construction of the heart chamber module.

Referring to fig. 1-3, the first basket 200 includes a plurality of bar-shaped first splines 201 uniformly arranged in a rotational direction of the axis of the catheter assembly 100, the first splines 201 extending in the L-axis direction, and the first electrode 400 is disposed on the first splines 201 to form a first electrode strip, and in the deployed state, the first splines 201 are deformed to form a bow-like shape. The first electrodes 400 of the first basket 200 positioned on the outer layer are configured as ultrasonic electrodes, the ultrasonic transducer is packaged inside the first electrodes 400, the first electrodes 400 are embedded on the outer surface of the first spline 201, a plurality of first electrodes 400 are arranged on one first spline 201, the plurality of first electrodes 400 on one first spline 201 are uniformly distributed along the L axial direction, the density of the first electrodes 400 arranged on the first basket 200 is higher, the surface area of the first electrodes 400 is larger, the width of the first electrodes 400 can be larger than the width of the first spline 201, and the width of the first electrodes can be smaller than the width of the first spline 201. Preferably, the first electrodes 400 on two adjacent first splines 201 are staggered; specifically, as shown in fig. 3e, one first electrode 400a on any one first spline 201a is located between two adjacent first electrodes 400b on adjacent first splines 201b, that is, the first splines 400 on adjacent first splines 201 are offset in the axial direction (axis L). The first electrodes 400 can be uniformly distributed as much as possible, so that the distribution density of ultrasonic beams on the spherical surface of the basket catheter is higher.

The ultrasonic transducer encapsulated in the first electrode 400 has a generally circular structure, or may have a hexagonal or octagonal structure, and can transmit an ultrasonic beam from the central axis of the ultrasonic transducer to the outside of the basket, and the first can be calculated based on the flight time of the ultrasonic waveThe distance between an electrode 400 and the endocardial surface,where d is the distance between the first electrode 400 and the endocardium, v is the speed of transmission of the ultrasound waves in the blood, and Δt is the time difference between the emission of the ultrasound energy and the reception of the ultrasound energy. The first basket 200 of the inner layer is preferably provided with 6-20 first splines 201, preferably 10; between 6 and 30 first electrodes 400, preferably 8, may be provided on each first spline 201. Specifically, 8 first electrodes 400 are disposed on each first spline 201, 80 first electrodes 400 are disposed on 10 first splines 201 in total, that is, 80 ultrasonic transducers are disposed on the first basket 200 in a distributed manner, each ultrasonic transducer transmits and receives ultrasonic energy to endocardial sites orthogonal to the first basket, a time difference Δt is recorded, a distance d between the ultrasonic transducer and the endocardial sites can be calculated, which corresponds to a position for obtaining one endocardial site, and 80 ultrasonic transducers are disposed on the first basket 200, so that in one ultrasonic detection, the position of 80 endocardial sites can be obtained. The refresh frequency of the sites can be 1-100Hz or higher, so that when the ultrasonic double-layer basket catheter rotates, more endocardial sites can be continuously detected, and a three-dimensional model of the endocardium can be constructed according to all the detected sites.

In the traditional modeling mode in the field of cardiac electrophysiology, a model in a heart cavity needs to be built by fully moving a catheter in the heart cavity and taking the volume of the catheter as a minimum filling unit, and the modeling mode is complex to operate and takes longer time as much as relying on experience of an operator. Compared with the traditional modeling mode, the ultrasonic modeling of the invention has the advantages that a plurality of ultrasonic electrodes (the first electrode 400) participate in the modeling at the same time, so that the modeling time is greatly shortened, meanwhile, as the ultrasonic electrodes are uniformly distributed on the spherical surface, an operator only needs to slightly rotate a catheter to finish the modeling, the operation difficulty is reduced, and the ultrasonic detection modeling mode of the invention can quickly construct a structural model of a heart chamber.

Referring to fig. 1-3, the second basket 300 has uniformly distributed thereon second electrode strips extending from a distal end to a proximal end thereof, the second electrode strips being formed of a plurality of regularly arranged second electrodes 500. The second basket 300 includes a plurality of bar-shaped second splines 301 uniformly arranged in the rotational direction of the axis of the catheter assembly 100, the second splines 301 extending in the L-axis direction, and the second electrode 500 is disposed on the second splines 301 to form a second electrode belt. In the unfolded state, the second spline 301 is deformed to form a similar arcuate shape.

In this embodiment, the second electrode 500 of the second basket 300 located at the inner layer is configured as a non-contact mapping electrode, and the second electrode 500 continuously performs non-contact mapping before, during and after the ablation performed by the first electrode 400, and records the electrical activity signal of the heart; the electrical activity signal of the heart includes one or more of current density, charge density, transmembrane potential, electric dipole density, local field potential, activation time, voltage, and repolarization time.

With reference to fig. 3a to 3d, the second electrodes 500 are embedded on the outer surface of the second spline 301, a plurality of second electrodes 500 are disposed on one second spline 301, and the plurality of second electrodes 500 on one second spline 301 are uniformly disposed along the L axis direction, the density of the second electrodes 500 disposed on the second basket 300 is higher, the surface area of the second electrodes 500 is larger, and the width of the second electrodes 500 can be set to be larger than the width of the second spline 301, so that the sensitivity of collecting signals can be improved. The second basket 300 of the inner layer is preferably provided with 6-20 second splines 301, preferably 10; 2-100 second electrodes 500, preferably 8, may be provided on each second spline 301. Unlike the second electrodes 500, the plurality of second electrodes 500 are disposed at intervals over the entire second spline 301, not only at the front half of the second spline 301 near the distal end. Each second electrode 500 is connected to the control handle 800 by a conductive wire, at least a portion of which is disposed inside the second spline 301, the portion of the conductive wire inside the second spline 301 is electrically connected to the portion of the second electrode 500 embedded in the second spline 301 and each second electrode 500 is connected by a separate conductive wire connection device such that each second electrode 500 can be addressed independently. The conductive wire may be embedded in the wall of a certain tube of the catheter assembly 100, or may be installed in a space formed between two catheters, and extend along the axis of the catheter assembly 100 to the proximal end to connect with the control handle 800, so as to electrically connect the second electrode 500 with the apparatus.

In the present embodiment, the arrangement of the second electrodes 500 is preferably a uniform arrangement. In the unfolded state of the catheter, the distance between the center points of two adjacent second electrodes 500 on the same second spline 301 is 0.5-5mm; preferably optimally 1.7mm. The shape of the second electrode 500 may be a sheet, a ring, a flower, or other shape. The upper second electrodes 500 of the second basket 300 are provided in 50-100, preferably 80.

In other embodiments, the relationship between the first electrode 400 and the second electrode 500 at the positions corresponding to the inner and outer layers may be a cross distribution, an overlapping distribution, or a partial overlapping or a partial cross.

In other embodiments, the size relationship between the first electrode 400 and the second electrode 500 may be the same size electrode, the outer layer may be a large electrode, the inner layer may be a small electrode, the inner layer may be a large electrode, the outer layer may be a small electrode, or the like.

Preferably, the first electrode 400 and the second electrode 500 each take the form of a sheet, which is constructed of a metal having superior ductility and softness, such as gold, silver, or the like.

With reference to fig. 3a-3e, on a plane perpendicular to the L axis, the second splines 301 and the first splines 201 are alternately arranged along the circumferential direction of the ultrasonic double-layer basket catheter, that is, each second spline 301 is opposite to the gap between two adjacent first splines 201, the second splines 301 are located in the gap between two adjacent first splines 201 and are arranged in a penetrating manner, so that shielding of the second basket 300 of the inner layer by the first basket 200 of the outer layer is avoided. In this embodiment, in the unfolded state, a certain distance is formed between the first basket 200 and the second basket 300, so that the second basket 300 and human tissues can always keep a certain distance, and therefore, the interference problem of mechanical impact on the non-contact mapping electrode (the second electrode 500) is solved, and the mapping result is more accurate and guaranteed.

In this embodiment, the expanded basket may be spherical, oblate spheroid, pear-shaped, or other shapes. After the basket is unfolded, the maximum diameter of the basket is 16-28mm, preferably 20mm, and under the condition that the volume of the basket is smaller, the maximum unfolded posture of the basket can be attached to the vestibule of an atrial pulmonary vein, so that the vestibule of the atrial pulmonary vein can be accurately positioned.

Referring to fig. 4-5 and 7-10, the catheter assembly 100 includes a first catheter 110, a second catheter 120, and a third catheter 130 sleeved with each other along a radial direction perpendicular to the L-axis, the first catheter 110 being telescopic within the second catheter 120 along the L-axis, a distal end of the first catheter 110 being connected to a proximal end of the guide head 600;

a bendable member is inserted at a distal location of the third catheter. The bendable member comprises a connection portion 141 and two symmetrically distributed pull wires 142. The proximal end of the connection portion 141 is inserted into the distal end position of the third catheter 130, the connection portion 141 is provided with a lumen through which the first catheter 110 and the second catheter 120 penetrate, the second catheter 120 extends to the distal end surface of the connection portion 141, and the first catheter 110 completely penetrates the lumen of the connection portion 141 and is connected to the proximal end of the guide head 600. The stay wire 142 is arranged in the separation chamber between the third catheter 130 and the second catheter 120, and a protective sleeve is sleeved outside the stay wire 142; the distal end of the pull wire 142 is connected to the proximal end of the connecting portion 141; specifically, the distal end of the pull wire 142 is formed as a ball, and the proximal end of the connecting portion 141 is provided with a groove that engages with the distal end ball of the pull wire 142. By pulling one of the wires 142, the bending of the bendable member in the direction of the position of the wire 142 can be controlled.

The catheter assembly 100 also includes conductive wires that may be embedded in the wall of a catheter or may be mounted in a compartment formed between two catheters in order to conduct electricity to the electrodes on the basket.

In some other embodiments, as shown in fig. 10, catheter assembly 100 may also employ conductive strips in place of conductive wires to conduct electricity to the electrodes. Specifically, a conductive strip is installed in the compartment formed between the first duct 110 and the third duct 130, the conductive strip including a number of first conductive strips 171 that conduct to the first electrodes 400 on the first splines 201 and a number of second conductive strips 172 that conduct to the second electrodes 500 on the second splines 301.

The plurality of first splines 201 may share one first conductive stripe 171, and preferably, two first splines 201 share one first conductive stripe 171; alternatively, three, four or five first splines 201 may share one first conductive stripe 171. For example, when ten first splines 201 are provided on the first basket 200, the first conductive stripes 171 may be provided in five.

Similarly, the plurality of second splines 301 also share one second conductive strip 172, and preferably, two second splines 301 share one second conductive strip 172; alternatively, three, four or five second splines 301 may share one second conductive strip 172. For example, when ten second splines 301 are provided on the second basket 300, the second conductive bars 172 may be provided in five.

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

Similarly, the proximal end of the second conductive layer is connected to the control handle 800, the distal end is connected to the second spline 301, and a plurality of conductive layers which are insulated from each other are also provided inside the second conductive strip 172, and each conductive layer is connected to one of the second electrodes 500, so that each of the second electrodes 500 can be addressed independently.

Further, the first conductive strip 171 is located closer to the third conduit 130 than the second conductive strip 172, i.e., within the compartment formed by the first conduit 110 and the third conduit 130, the second conductive strip 172 is located closer to the L axis, and the first conductive strip 171 is located farther from the L axis, i.e., the first conductive strip 171 is located outside the second conductive strip 172.

Referring to fig. 3b, 5-10, a delivery lumen 111 is formed within first catheter 110, and a guidewire capable of extending and retracting from the distal end of first catheter 110 may be provided, with first catheter 110 penetrating guide head 600 and extending to the distal end face of guide head 600. In practice, the delivery lumen 111 may be capable of delivering various fluids, such as saline, contrast media, and the like, in addition to the guidewire. When heparin saline is to be infused to prevent thrombosis, the distal end portion of the first catheter 110 may also be designed as a blind end, with the exposed portion of the second basket 300 at the junction of the distal and proximal ends thereof being provided with wall holes, extension tubes, etc., through which heparin saline is infused; alternatively, the catheter assembly 100 is provided with a perfusion tube 113 in parallel with the first catheter 110, and heparin saline is perfused through the perfusion tube 113. The heparin saline can be poured to effectively prevent tissue blood from coagulating, so that the catheter can work more safely.

Preferably, the first conduit 110, the second conduit 120 and the third conduit 130 are coaxially arranged and extend along the L-axis, and the first conduit 110, the second conduit 120 and the third conduit 130 are flexible, i.e. bendable. The first, second and third catheters 110, 120, 130 are each constructed of polyurethane or PEBAX (polyether block amide), and the third catheter 130 located on the outermost surface side may also be provided with an embedded braided mesh of stainless steel or the like to increase torsional rigidity of the catheter assembly 100 itself so that the distal end portion of the catheter assembly 100 itself will rotate in a corresponding manner when the control handle 800 is rotated.

In this embodiment, the wall thicknesses of the first duct 110, the second duct 120, and the third duct 130 are substantially as follows, and the wall thicknesses of the first duct 110 and the second duct 120 are 0.10mm; the third conduit 130 is supported and the wall thickness is set to 0.20mm.

Referring to fig. 5, the connection sleeve 700 is in a sleeve shape, and the connection sleeve 700 is directly nested to the outer wall of the connection part 141 and fused together. The outer ring diameter of the connection sleeve 700 is the same as the outer ring diameter of the third catheter 130; thus, the outer wall of the connection sleeve 700 is matched with the outer wall of the third duct 130.

Referring to fig. 6a-6c, a guide head 600 connects the distal ends of the first basket 200, the second basket 300, and the guide head 600 connects the distal end of the first catheter 110. The deployment of the first basket 200 and the second basket 300 can be controlled by the first catheter 110; when the first catheter 110 is retracted, the first basket 200, the second basket 300 are deployed simultaneously; when the first catheter 110 is extended, the first basket 200 and the second basket 300 are contracted simultaneously.

Referring to fig. 6a-6c, the guide 600 may alternatively be a conventional hat. The following structure may also be adopted, the guide head 600 includes a connecting piece 601 and a fastener 602, the distal ends of the first basket 200 and the second basket 300 are respectively inserted into the hole of the connecting piece 601 from the distal end and the proximal end of the connecting piece 601, the fastener 602 is in a rivet-shaped mounting position of the distal end of the connecting piece 601, the distal end surface of the fastener 602 is disposed in the hole communicated with the first catheter 110, and the distal end surface of the fastener 602 is an arc surface. In the present catheter deployed state, the distal end face of the fastener 602 does not protrude beyond the distal end face of the first basket 200; in this embodiment, the distal surface of the first basket 200 preferably coincides with the distal surface of the fastener 602. The guiding end (namely the far end) of the catheter can be ensured to be smooth, and the trauma to the human body is reduced when the catheter is guided into the human body diseased tissue.

In some other embodiments, the distal end surface of the guide head 600 may also protrude slightly beyond the distal end surface of the first basket 200 in the deployed state by a distance of less than 2mm.

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

Alternatively, as shown in fig. 6b, the portion of the first spline 201 inserted into the connector 601 is in the same plane as the portion of the second spline 301 inserted into the connector 601, specifically, the inserted portion of the first spline 201 is bent in the proximal direction from the distal end of the guide head 600 to the inner wall of the fitting connector 601, and the inserted portion of the second spline 301 is bent in the distal direction from the proximal end of the guide head 600 to the inner wall of the fitting connector 601, so that the first spline 201 and the second spline 301 are in the same plane (the inner wall plane of the connector 601).

Alternatively, as shown in fig. 6c, a portion of the first spline 201 inserted into the inside of the connection member 601 and at least a portion of the second spline 301 inserted into the inside of the connection member 601 overlap each other. Specifically, the insertion portion of the second spline 301 is bent in the distal direction from the proximal end of the guide head 600 to the inner wall of the fitting connection 601, and the insertion portion of the first spline 201 is bent in the proximal direction from the distal end of the guide head 600 to the inner wall of the insertion portion of the second spline 301, and the insertion portions are superimposed on each other. The insertion portion of the first spline 201 may be folded and attached to the inner wall of the connector 601, and the insertion portion of the second spline 301 may be folded and attached to the inner wall of the first spline 201.

11-12, the method for manufacturing the basket in the catheter is to use a 3D printing technology, and specifically comprises the following steps:

s1, respectively printing two spline arrays containing electrodes, wherein the proximal ends of the splines are connected through a connecting part.

S2.1, in the first basket 200 positioned on the outer layer, a first connecting part 701 is arranged at the proximal end part of a plurality of first splines 201, a plurality of first electrodes 400 are arranged on each first spline 201, and two ends of the first connecting part 701 are welded to form a round shape.

S2.2, manufacturing the second basket in the inner layer by the same method, wherein the proximal end parts of the second splines 301 are provided with second connecting parts 702, each second spline 301 is provided with a plurality of second electrodes 500, and two ends of each second connecting part 702 are welded to form a round shape.

S3, the second connecting part 702 is sleeved in the first connecting part 701, and the second connecting part 702 and the first connecting part 701 are welded to form the connecting sleeve 700.

S4, the distal ends of the first spline 201 and the second spline 301 are connected by the guide head 600, as shown in fig. 6a-6c.

Referring to fig. 14, control handle 800 includes a handle body, a deployment adjustment assembly, a bend adjustment assembly, a guidewire inlet assembly, and an electrical connector. The deployment adjusting assembly, the bend adjusting assembly, the guidewire control assembly, and the electrical connector are all disposed within the handle body, and the proximal ends of the second and third catheters 120, 130 are mounted at the distal end of the handle body. The deployment adjustment assembly is connected to the proximal end of the first catheter 110, the bend adjustment assembly is connected to the proximal end of the pull wire 142, the lumen of the first catheter 110 is connected to the guidewire inlet assembly, and the conductive wire is electrically connected to the electrical connector.

In this embodiment, the working end of the present catheter is delivered to the patient tissue, and the first basket 200 and the second basket 300 are deployed to treat the patient tissue. The first electrode 400 of the first basket 200 positioned on the outer layer is contacted or not contacted with the tissue of the patient, ultrasonic detection is carried out, and the position data of enough endocardial sites are detected, so that a structural model of the heart chamber is constructed; since the outer first basket 200 is unfolded, the second electrode 500 of the inner second basket 300 is just spaced from the patient tissue, enabling a stable non-contact mapping.

In a conventional and practical cardiac operation using non-contact mapping, a basket catheter is positioned in cardiac tissue, and the basket catheter is mapped without contacting the cardiac tissue. However, due to the beating of the heart, when the atrium contracts, the tissue often hits the surface of the catheter, resulting in a mechanical change of the shape of the basket and direct contact of the tissue with the electrode; in this case, fluctuations may be caused to the recorded mapping data, and some incorrect data may be generated, so that this case requires that some signal data recorded when the heart contracts are removed after the operation is completed according to previous experience, and some important data may be removed due to insufficient experience or negligence. However, in the present catheter, the first basket 200 of the outer layer is deployed, so that the second electrode 500 of the second basket 300 of the inner layer forms a stable distance with the patient tissue, so that the first basket can protect the second basket 300, and can avoid the inner layer second basket 300 from being impacted during heart beating, so that very stable non-contact mapping can be performed, and the mapping data is stable, and the mapping data set does not need to be screened, so that a mapping result with higher accuracy is obtained.

According to the ultrasonic double-layer basket catheter, the functions of ultrasonic detection and non-contact mapping are realized on the same catheter, the problem of impact interference of the non-contact mapping is solved, feedback modeling is carried out on patient tissues through mapping and ultrasonic detection, a structural model of a heart can be accurately drawn, and a heart electrical activity conduction diagram is drawn so as to facilitate the establishment of various subsequent treatment schemes.

Example two

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

with reference to fig. 13, a magnetic sensor 901 is provided on the first catheter 110 near the distal end, and the magnetic sensor 901 may be sleeved outside the first catheter 110, or the magnetic sensor 901 may be wrapped inside the first catheter 110. The magnetic sensor 901 is disposed within the second basket 300, and in particular, the magnetic sensor 901 is located at a distal position within 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.

With reference to fig. 13, a central reference electrode 902 is embedded on the surface of the magnetic sensor 901 at the distal end of the first catheter 110, and the central reference electrode 902 is used as a reference for other electrodes, so as to assist the other electrodes in recording the electrical activity of the heart, and a separate conductive wire or conductive layer is also connected to the central reference electrode 902, so as to be independently addressable. Specifically, when the second electrode 500 is subjected to non-contact mapping, the second electrode 500 may be configured as an anode, the central reference electrode 902 may be configured as a ground, an electrical signal between the second electrode 500 and the central reference electrode 902 may be recorded, and a unipolar electrogram may be recorded, which may provide information of the proximity or the distance of the heart electrical activity from the electrodes, unlike a bipolar electrogram recorded between the two second electrodes 500. Of course, at the time of the marking, the second electrode 500 may be set as a negative electrode, the central reference electrode 902 is still set as ground, and a monopolar electrogram may be recorded.

In some other embodiments, the central reference electrode 902 may not be disposed on the surface of the magnetic sensor 901, may be disposed on the first catheter 110, and may be disposed proximate to the magnetic sensor 901.

Further, the magnetic sensor 901 is mounted on the basket catheter to position and track the ultrasonic double-layer basket catheter in the body. In the prior art, when medical staff operates the catheter, the catheter can be generally observed through X rays, but the X rays radiate the medical staff, so that the risk of cancer replacement of the medical staff is increased, and the auxiliary positioning through the magnetic sensor is provided in the embodiment, so that the X-ray dosage of operation can be reduced.

The electric field navigation is to apply a near-orthogonal patch on the surface of a patient, the patch emits excitation current with a certain frequency, and the position information of the working end of the ultrasonic double-layer basket catheter can be obtained by calculating the change of the resistance between the central reference electrode 902 and the patch. The electric field positioning accuracy is easily affected by a human body, the electric impedance of the human body is greatly affected by breathing and body surface sweat, and a coordinate system established by the electric impedance is spatially distorted. It is therefore necessary to simultaneously establish a magnetic field coordinate system to calibrate the position information of the electric field localization.

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, so that navigation and positioning of magneto-electric fusion of the catheter can be realized. Specifically, in the same position in the heart chamber, the device can collect the data (x, y, z coordinate parameters) of the electric channel on the central reference electrode 902 and the data (x, y, z coordinate parameters) of the magnetic channel of the magnetic sensor 901 at the same time, then the two are in one-to-one correspondence, when the catheter moves fully in the heart chamber, after collecting the sufficiently dense coordinates, any electrode on the catheter can find the corresponding data (coordinate information) of the magnetic channel in the space, and knowing the data of one channel (electrode) in a certain space position can infer the data of the other channel (electrode) in the space position.

The basic idea of the algorithm is as follows:

the process of building the table: and establishing a multilevel index table of the magnetoelectric data pair corresponding to the three-dimensional space position according to the existing standard magnetoelectric data pair. Specifically, the catheter is fully moved in the heart chamber, the electrical channel data of the central reference electrode 902 and the magnetic channel data of the magnetic sensor 901 at each position are collected, and then the relationship between the electrical channel data and the magnetic channel data is subjected to one-to-one correspondence to establish an index table, namely, a space coordinate system of magnetoelectric combination is established.

The table look-up process: after the data acquired by any electrode channel on the catheter, the magnetic channel data corresponding to the electric channel data are searched in the multi-level index table through the electric channel data, and the magnetic field coordinate system is spatially uniform and accurate, so that the spatial position obtained through the corresponding relation of the electric-magnetic space is also accurate, and accurate navigation of the catheter is realized.

In the description of the present invention, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance unless explicitly specified or limited otherwise; the term "plurality" means two or more, unless specified or indicated otherwise; the terms "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, integrally connected, or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the description of the present specification, it should be understood that the terms "front", "rear", "upper", "lower", "inner", "outer", and the like in the embodiments of the present invention are described in terms of angles shown in the drawings, and should not be construed as limiting the embodiments of the present invention. In addition, in the context of a description, it will be understood that when an element is referred to as being "in front of" or "behind" another element, it can be directly connected to the other element or be indirectly connected to the other element through intervening elements.

What has been described above is merely some embodiments of the present invention. It will be apparent to those skilled in the art that various modifications and improvements can be made without departing from the spirit of the invention.

Claims

1. Ultrasonic double-layer basket catheter, its characterized in that includes:

a catheter assembly;

2. The ultrasonic double-layer basket catheter of claim 1 wherein the second basket includes a plurality of uniformly disposed elongated deformable second splines, each of the second splines having a plurality of the second electrodes disposed thereon.

3. The ultrasonic double layer basket catheter of claim 2 wherein each second spline is opposite a gap between two adjacent first splines.

4. The ultrasonic double-layer basket catheter of claim 1 wherein one first electrode on any one first spline is located between two adjacent first electrodes on adjacent first splines.

5. The ultrasonic double-layer basket catheter of any one of claims 1-4 wherein the ultrasonic transducer within each first electrode is configured to transmit and receive ultrasonic energy to thereby enable calculation of the distance between the ultrasonic transducer and a site of an endocardial surface orthogonal to the ultrasonic transducer.

6. The ultrasonic double-layer basket catheter of claim 5 wherein a plurality of the first electrodes are in contact or non-contact ultrasonic detection with a body member and a plurality of distance data are measured to construct a structural model of the heart chamber.

7. The ultrasonic double layer basket catheter of claim 5 wherein the second electrode is configured as a non-contact mapping electrode for recording electrical activity signals of the heart.

8. The ultrasonic double-layer basket catheter of claim 7 wherein the electrical activity signal of the heart comprises one or more of current density, charge density, transmembrane potential, electric dipole density, local field potential, activation time, voltage, and repolarization time.

9. The ultrasonic double-layered basket catheter of claim 7 wherein the catheter assembly comprises a telescoping first catheter having a distal end provided with a guide head for connecting the distal ends of the first basket and the second basket, the first catheter controlling the guide head connected thereto by telescoping operation so as to simultaneously expand or contract the first basket and the second basket.

10. The ultrasonic double-layer basket catheter of claim 9 wherein a central reference electrode is provided on the first catheter near the distal end for assisting the second electrode in recording the electrical activity of the heart.

11. The ultrasonic double-layer basket catheter of claim 10 wherein when the second electrode is non-contact labeled, the second electrode is configured as either positive or negative and the central reference electrode is configured as ground, recording the electrical signal between the second electrode and the central reference electrode results in a monopolar electrogram.

12. The ultrasonic double-layer basket catheter of claim 11 wherein the first catheter is provided with a magnetic sensor at a location near the distal end that enables positioning and tracking of the ultrasonic double-layer basket catheter.

13. The ultrasonic double-layer basket catheter of claim 12 wherein the positional information of the double-layer basket ablation catheter is obtained by acquiring magnetic channel data of the magnetic sensor and/or electrical channel data of the central reference electrode.

14. The ultrasonic double-layer basket catheter of claim 2 wherein the first basket comprises at least six first splines and the second basket comprises at least six second splines.

15. The ultrasonic double layer basket catheter of claim 14 wherein the number of first splines is six, eight, ten or twelve; the number of the second splines is six, eight, ten or twelve.

16. The ultrasonic double-layer basket catheter of claim 15 wherein twelve first electrodes are provided on each of the first splines and eight second electrodes are provided on each of the second splines; or, twenty first electrodes are arranged on each first spline, and eight second electrodes are arranged on each second spline.