CN113243987A

CN113243987A - Ablation catheter system adopting combined electrode

Info

Publication number: CN113243987A
Application number: CN202110480949.6A
Authority: CN
Inventors: 谭家宏
Original assignee: Shanghai Xinlutong Life Technology Co ltd
Current assignee: Shanghai Xinlutong Life Technology Co ltd
Priority date: 2021-04-30
Filing date: 2021-04-30
Publication date: 2021-08-13

Abstract

The invention designs an ablation catheter system adopting a combined electrode, which comprises an ablation energy system console, a pacing and ECG unit and an ablation catheter, wherein the ablation catheter comprises a proximal section, a main body middle section and a distal section which are sequentially connected; the ablation catheter is connected to an ablation energy system console, and ablation energy is transmitted to the ablation tissue through an electrode on the ablation catheter; the catheter distal section comprises an elastically telescopic spline basket, the spline basket comprises a plurality of extensible splines with a plurality of electrodes, and at least one electrode in the plurality of electrodes is a bendable electrode and is suitable for different ablation requirements.

Description

Ablation catheter system adopting combined electrode

Technical Field

The invention relates to the field of medical instruments, in particular to an ablation catheter system adopting a combined electrode.

Background

Cardiac ablation has experienced a great deal of innovation and rapid development since its first implementation in 1969. Ablation was used primarily for the treatment of supraventricular tachycardia patients with accessory pathways and pre-excitation syndrome, and today ablation is also used for the treatment of atrial flutter, atrial fibrillation and ventricular arrhythmias.

The purpose of ablation is to destroy potentially arrhythmic tissue and form transmural and continuous permanent lesions. Percutaneous catheter ablation to achieve Pulmonary Vein (PV) isolation in atrial tissue using radio-frequency ablation (RFA) and cryoablation therapy has become a widely accepted procedure for treating Atrial Fibrillation (AF). Other energy forms of catheter ablation include microwaves, high intensity focused ultrasound, low intensity collimated ultrasound, lasers, cryogenic energy, and heated saline.

Radio-frequency (RF) energy is currently the most commonly used energy source. RF creates lesions by resistively heating tissue and then conducting heat to deeper tissue.

Irreversible electroporation (IRE) is a rapidly developing and FDA-approved treatment for solid tumors. IRE is a promising approach for cardiac ablation, especially in comparison to RF, where it can produce foci without the side effects of thermal conduction, i.e. the ability to preserve surrounding tissue structure, a field in which such voltage pulses are more commonly referred to as Pulsed Field Ablation (PFA). Aiming at the ablation of radio frequency ablation, pulse electric field and the like, how to deal with different ablation conditions, improve the ablation efficiency and the safety, and achieve the aim of quickly, safely and effectively treating diseases such as arrhythmia and the like, the method is a difficult problem to be solved in the technology.

Chinese patent CN111772783A discloses an ablation system with bendable electrodes, which comprises an ablation energy system console, a pacing and ECG unit and an ablation catheter. The ablation energy source is radio frequency or voltage pulse, the ablation catheter is connected to the ablation energy system console through a converter, and the ablation energy is transmitted to the ablation tissue through an electrode on the ablation catheter, so that tissue cells are denatured. The ablation catheter comprises a spline basket formed by a plurality of splines, and at least one bendable electrode is arranged on each spline, so that the bending electrode is perfectly attached to the tissue, and a better ablation effect is achieved. A guide wire cavity is formed in the spline basket catheter, and a guide wire entering the pulmonary vein helps the spline basket to be better positioned and attached to the vestibule of the pulmonary vein, so that the success rate of pulmonary vein isolation is improved. The distal end can be also provided with a ring catheter entering the pulmonary vein, different electrode arrangements contacting tissues and various combinations among addressable electrodes form various different discharge modes, and large-area damage in local, linear, ring or uniform distribution can be formed, so that the purpose of treating arrhythmia diseases such as atrial augmentation, supraventricular tachycardia, ventricular tachycardia, atrial fibrillation and the like is achieved. However, the invention cannot be used in the case of ablation of non-vascular orifices, the spline basket is also not convenient for real-time detection of electrocardiographic signals, and the ablation efficiency can be further improved by partially modifying the spline basket.

Chinese patent CN111728693A discloses a system for treating arrhythmia by using pulsed electric field ablation technology, which comprises a voltage pulse system console, a pacing and ECG unit and an ablation catheter. The voltage pulse system console includes an electrical pulse generator, a controller, a human-machine interface, and a converter. The pacing and ECG unit comprises an ECG recorder, a pacing catheter, a cardiac stimulator and a mapping catheter, and pacing electric signals are synchronously transmitted to a voltage pulse system console. The ablation catheter is connected to a system console via a transducer, and based on the pacing signal, delivers a voltage pulse waveform during a refractory period of the cardiac cycle, delivering pulsed electric field energy to the ablated tissue via electrodes on the ablation catheter. The ablation catheter comprises a spline basket, the distal end of the spline basket is also provided with an annular catheter entering the pulmonary vein, and large-area irreversible injury in local, linear, annular or uniform distribution can be formed, so that the purpose of treating arrhythmia diseases such as atrial augmentation, supraventricular tachycardia and atrial fibrillation is achieved. However, this system is not suitable for use in radio frequency ablation and in ablation of non-vascular orifices.

Therefore, the technical problem to be solved by those skilled in the art is how to provide an ablation system suitable for the ablation diagnosis and treatment of the annular vein orifice as well as the ablation diagnosis and treatment of the non-vein orifice, radio frequency ablation, pulsed electric field ablation, and the like.

Disclosure of Invention

In order to achieve the above purpose, the present application provides the following technical solutions on the basis of chinese patent CN 111772783A.

An ablation catheter system adopting a combined electrode comprises an ablation energy system console, a pacing and ECG unit and an ablation catheter;

the ablation catheter comprises a proximal section, a main body middle section and a distal section which are sequentially connected; the ablation catheter is connected to an ablation energy system console, and ablation energy is transmitted to the ablation tissue through an electrode on the ablation catheter;

the distal section of the catheter comprises an elastically telescopic spline basket, the spline basket comprises a plurality of extensible splines with a plurality of electrodes, and at least one electrode in the plurality of electrodes is a bendable electrode;

the electrodes of each spline on the spline basket comprise one or more combinations of the following four conditions according to the arrangement sequence:

1) a flexible electrode and a ring electrode;

2) a flexible electrode and two ring electrodes;

3) one flexible electrode and three ring electrodes;

4) two bendable electrodes.

The spline basket has the following two conditions according to the stretched shape:

1) a basket-like sphere shape;

2) petal shape.

Preferably, the proximal section of the ablation catheter comprises a control handle; the middle section of the main body is a slender tube body which is of a hollow inner cavity structure and comprises an outer tube, a wire, a stay wire, an inner tube and a wire guide cavity.

Preferably, the distal end part of the spline is provided with a bendable electrode sleeved outside the insulating branch pipe, and each electrode selects an electrode of the same spline or an electrode on an adjacent spline to carry out positive and negative pairing so as to realize voltage pulse bipolar discharge ablation; can also be connected with a radio frequency instrument to perform single-stage or multi-stage radio frequency ablation.

Preferably, the bendable electrode is of a bracket structure and is formed by an electrode formed by a single-strand or multi-strand wire electrode, and the multi-strand is preferably 2-5.

The annular electrode is an annular conductive metal sheet and is tightly attached to the surface of the spline.

Preferably, the bendable electrode support structure is replaced by a spring structure formed by arranging single wires or multiple wires or a metal wire woven mesh structure formed by weaving a plurality of round wires or flat wires, wherein each spring or woven mesh corresponds to one bendable electrode.

Preferably, the material of the flexible electrode or ring electrode is platinum, platinum alloy, gold alloy, copper, stainless steel, nickel titanium alloy, MP35N or a metal composite structure with X-ray development components, such as a non-developed bulk composite structure with X-ray development coating.

Preferably, the spline basket is in a basket-shaped sphere shape or a petal shape after being stretched.

Preferably, the proximal end of the spline basket is connected to a fixing piece of the middle section of the catheter body, the fixing piece is connected to a control handle of the proximal section through a pull wire, the control handle is used for realizing bending of the spline basket, and the spline basket is adjusted to different positions.

The length of the bendable electrode is 2 mm-20 mm, and the outer diameter is 2F-10F; the length of the annular electrode is 0.5 mm-5 mm, the outer diameter is 2F-10F, and the distance between adjacent electrodes on the same spline is 0.5 mm-20 mm;

preferably, the length of the bendable electrode is 4 mm-10 mm, and the outer diameter is 2F-7F; the length of the annular electrode is 0.5 mm-3 mm, and the outer diameter is 2F-7F; the distance between adjacent electrodes on the same spline is 0.5 mm-6 mm.

Preferably, the distance between the adjacent electrodes on the same spline is 1 mm-4 mm.

Preferably, the spline basket comprises 3-12 splines, preferably 4-8 splines; the spline of the spline basket is composed of an elastic single-cavity tube made of medical high polymer materials.

Preferably, the splines are flexible single lumen tubes with X-ray contrast.

Preferably, the distal section further comprises a ring-shaped catheter or guide wire extending to the distal end of the spline basket through a catheter guide wire cavity, the ring-shaped catheter or guide wire can enter the vascular cavity, and the ring-shaped catheter is provided with electrodes for performing discharge ablation and mapping.

Preferably, the electrode is tightly matched on the surface of the spline, and the proximal end of the electrode is connected with the lead and extends to the handle; and an annular catheter or a guide wire in the catheter guide wire cavity enters the cavity to help the spline basket to be positioned and attached at the cavity opening.

The beneficial effects obtained by the invention are as follows:

(1) the splines in the spline basket are covered with the bendable electrodes or the annular electrodes, the ablation range can be adjusted by adjusting the structures, the numbers and the combination of the bendable electrodes and the annular electrodes, and the device has strong flexibility and wide application range;

(2) the positive and negative paired discharge ablation between the bendable electrode on the spline and the annular electrode greatly increases the ablation area and improves the ablation efficiency;

(3) when other electrodes are discharged and ablated, the ring electrode at the near end can be matched with the electrode on the adjacent spline to carry out real-time mapping on electrocardiosignals, and once the real-time mapping meets the electrocardio blocking requirement, ablation can be stopped, so that the damage to tissues is reduced to the maximum extent;

(4) the guide wire is divided into an annular guide wire and a tail end elbow guide wire according to the shape, and the annular guide wire is convenient to fix in the cavity. The tail end elbow guide wire is linear, is convenient to move in a blood vessel and has strong flexibility;

(5) the spline basket is divided into a basket-shaped sphere shape and a petal shape according to the shape, and the basket-shaped sphere-shaped spline basket with the bendable electrodes has high flexibility and strong fitness with tissues and is suitable for ablation of vein orifices with different sizes. And the longer bendable electrode can cover the vestibules of vessels with different calibers, so that the spline basket catheter with one size can meet the requirements of all patients.

(6) The two ends of the spline of the petal-shaped catheter are connected, and when no annular catheter or guide wire is used in cooperation, the petal-shaped catheter is suitable for ablation of non-vascular orifice parts, such as ablation of the back wall and the top of an atrium, and the requirement of ablation of continuous atrial fibrillation is met.

The foregoing description is only an overview of the technical solutions of the present application, so that the technical means of the present application can be more clearly understood and the present application can be implemented according to the content of the description, and in order to make the above and other objects, features and advantages of the present application more clearly understood, the following detailed description is made with reference to the preferred embodiments of the present application and the accompanying drawings.

The above and other objects, advantages and features of the present application will become more apparent to those skilled in the art from the following detailed description of specific embodiments thereof, taken in conjunction with the accompanying drawings.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts, and these drawings are all within the protection scope of the present application. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

FIG. 1 is a schematic view of the overall structure of an ablation catheter system employing a combination electrode as disclosed herein;

FIG. 2 is a schematic structural view of a first embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 3 is a schematic structural view of a second embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 4 is a schematic structural view of a third embodiment of the disclosed ablation catheter employing a combination electrode; .

FIG. 5 is a schematic structural view of a fourth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 6 is a schematic structural view of a fifth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 7 is a schematic structural view of a sixth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 8 is a schematic structural view of a seventh embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 9 is a schematic structural view of an eighth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 10 is a schematic structural view of a ninth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 11 is a schematic structural view of a tenth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 12 is a schematic structural view of a tenth embodiment of the presently disclosed ablation catheter employing a combination electrode;

FIG. 13a is a schematic diagram of a single-strand bendable electrode structure disclosed in the present invention;

FIG. 13b is a schematic diagram of a structure of a bifilar bendable electrode disclosed in the present invention;

fig. 13c is a schematic view of a structure of a snap-in bendable electrode disclosed in the present invention.

Description of reference numerals: 131. a distal segment; 132. a main body middle section; 133. a proximal segment; 321. a catheter body; 331. a control handle; 332. a connecting assembly; 333. a stopper; 334. a lever or knob; 335. a wire drawing assembly; 336. a connector; 210. a spline basket; 211. a spline; 212. a bendable electrode; 213. an insulating tube; 214. a ring electrode; 215. a guide bar; 220. a guidewire.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. In the following description, specific details such as specific configurations and components are provided only to help the embodiments of the present application be fully understood. Accordingly, it will be apparent to those skilled in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present application. In addition, descriptions of well-known functions and constructions are omitted in the embodiments for clarity and conciseness.

It should be appreciated that reference throughout this specification to "one embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrase "one embodiment" or "the present embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Further, the present application may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.

The term "and/or" herein is merely an association describing an associated object, meaning that three relationships may exist, e.g., a and/or B, may mean: a exists alone, B exists alone, and A and B exist at the same time, and the term "/and" is used herein to describe another association object relationship, which means that two relationships may exist, for example, A/and B, may mean: a alone, and both a and B alone, and further, the character "/" in this document generally means that the former and latter associated objects are in an "or" relationship.

The term "at least one" herein is merely an association relationship describing an associated object, and means that there may be three relationships, for example, at least one of a and B, may mean: a exists alone, A and B exist simultaneously, and B exists alone.

It is further noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion.

The invention is shown in figure 1, which is a schematic diagram of the overall structure of an ablation catheter system using a combined electrode.

Referring to fig. 1, a schematic diagram of an overall structure of an ablation catheter system using a combined electrode is shown, which illustrates an ablation catheter system using a combined electrode, and includes:

comprises an ablation energy system console, a pacing and ECG unit and an ablation catheter;

the ablation energy source is radio frequency or voltage pulse, the ablation catheter is connected to the ablation energy system console through a converter, and ablation energy is transmitted to the ablation tissue through an electrode on the ablation catheter, so that tissue cells are denatured.

Referring to fig. 1, the ablation catheter includes a distal section 131, a body intermediate section 132, and a proximal section 133 connected in series.

The catheter distal section 131 includes a resiliently collapsible splined basket 210, the splined basket 210 including a plurality of extendable splines 211 with bendable electrodes 212 and ring electrodes 214, and a hollow pushrod 215.

Further, the distal section 131 includes a treatment head, such as a splined basket 210.

The main body middle section 132 is a slender tube body, and the tube body is a hollow inner cavity structure.

Comprises an outer tube, a lead, a stay wire and an inner tube with a guide wire cavity; for saline-filled catheters, there is also a saline lumen.

The proximal segment 133 includes a control handle 331. the control handle 331 includes a connecting assembly 332 for receiving a guide wire or a circular catheter, and a connector 336 connected to the handle body.

Further, the control handle 331 includes a wire assembly 335 for bending the head part of the distal section 131, a lever or knob 334, and a stopper 333. The proximal end of the pull wire assembly 335 may be anchored to a member, such as a cam, that is responsive to the lever or knob 334. Detent 333 is movably coupled to the proximal portion of the catheter and/or control handle 331 through the inner tube to manipulate and move hollow push rod 215 of distal segment 131.

Further, the detent 333 comprises a sliding key, button, rotating lever or other movable connection to the control handle 331 and to the hollow push rod 215 on the splined basket 131.

In one embodiment, the control handle 331 has a slider bar, gear and pull wire structure therein, and the stopper 333 is connected to the hollow push rod 215 of the splined basket 210, and the splined basket 210 is retracted by rotating or pushing and pulling the control handle 331 to form the splined basket 210, the petal catheter 210, or straightening the splines 211 in preparation for repositioning or ablating other pulmonary veins. The pull wire of the other set of position control mechanism is connected to the proximal end of the spline basket 210, and the direction of the spline basket 210 is controlled by a knob or a push button on the handle, so that the spline basket 210 is perfectly attached to pulmonary vein orifices in different positions.

The outer tube of the main body middle section 132 is a medical polymer tube with excellent performance, preferably a woven mesh tube with excellent torsion control performance, and is of a single-cavity or multi-cavity structure.

Furthermore, the woven mesh tube comprises an inner cavity insulating material, a middle woven mesh and an outer layer insulating material. The inner cavity insulating material is TPU or Pebax, and can also be polyimide, FEP, ETFE and PTFE with smaller friction coefficient and better insulating property; the middle mesh grid is woven by stainless steel, Nitinol and other alloy wires; the outer layer is made of biocompatible electric insulating materials such as TPU, Pebax, nylon and the like.

In one embodiment, the braided outer tube of the ablation catheter body middle section 132, if of single lumen construction, is formed with a TPU, PeBax, silicone rubber, polyimide, FEP, ETFE, PTFE, PEEK, metal, inner tube with a guidewire lumen, the distal end extending into the spline basket 210, and connected to the hollow push rod 215; the proximal end enters the control handle 331 and forms a guidewire lumen with the lumen in the luer fitting through which the guidewire 220 passes to the pulmonary vein. The inner tube may also be a woven mesh tube.

In one embodiment, the ablation catheter distal section 131 is a mesh-covered balloon with electrodes embedded in the balloon surface to perform electrical discharge ablation.

In one embodiment, the distal ablation catheter section 131 is of an annular multi-polar configuration, the catheter is adapted to the pulmonary vein ostium, has an outer diameter of 1.5-5 cm, and has 4-16 electrodes, forming a complete pulmonary vein isolation.

As shown in fig. 2, in one embodiment, the basket-like ball spline basket with the looped guidewire or looped catheter is covered with a bendable electrode and a looped electrode;

as shown in fig. 3, in one embodiment, a basket-like spherical spline basket with a looped guidewire or looped catheter is covered with one bendable electrode and two looped electrodes;

as shown in fig. 4, in one embodiment, a basket-like spherical spline basket with a looped guidewire or looped catheter is covered with one bendable electrode and three looped electrodes;

as shown in fig. 5, in one embodiment, the basket-shaped spherical spline basket with the end bend guide wire is covered with a bendable electrode and a ring electrode;

as shown in fig. 6, in one embodiment, the basket-shaped spherical spline basket with the end bend guide wire is covered with one bendable electrode and two ring electrodes;

as shown in fig. 7, in one embodiment, the basket-shaped spherical spline basket with the end bend guide wire is covered with one bendable electrode and three ring electrodes;

as shown in fig. 8, in one embodiment, a splined petal catheter fitted with an annular guide wire or annular catheter;

as shown in fig. 9, in one embodiment, a splined petal catheter fitted with a distal elbow guide wire;

as shown in fig. 10, in one embodiment, a splined basket fitted with a looped guidewire or looped catheter is covered with two bendable electrodes;

in one embodiment, the splined basket with the end bend guidewire is covered with two bendable electrodes as shown in figure 11.

As shown in fig. 12, in one embodiment, there is no petal spline shaped catheter for the guide wire or annular catheter.

As shown in fig. 2-12, the treatment head component of the distal segment 131 comprises an expandable spline basket 210, wherein the spline basket 210 comprises a plurality of flexible expandable splines 211 with bendable electrodes, and the number of the splines 211 is 3-12, preferably 4-8.

The main body of the spline 211 is an insulating tube 213, and the distal end of the spline 211 is provided with a bendable electrode 212. The length of the bendable electrode 212 is 2 mm-20 mm, the outer diameter is 2F-10F, the bendable electrode clings to the outer wall of the spline 211, and the inner diameter is close to the spline 211. The medial and/or proximal ends of the spline 211 are provided with ring electrodes 214. The length of the annular electrode 214 is 0.5 mm-5 mm, the outer diameter is 2F-10F, the annular electrode is tightly attached to the outer wall of the spline 211, the inner diameter is close to the spline 211, and the distance between adjacent electrodes on the same spline is 0.5 mm-20 mm.

Furthermore, the length of the bendable electrode is 4-10 mm, and the outer diameter is 2-7F; the length of the annular electrode is 0.5 mm-3 mm, and the outer diameter is 2F-7F; the electrode spacing is 0.5 mm-6 mm.

2-7, the number of splines is 6, and the bendable electrode 212 fits snugly against the distal portion of the spline 211, preferably covering 1/6-1/2 of the length of the spline 211 catheter; the ring electrode 214 is positioned proximate the middle and/or proximal portions of the splines, preferably covering 1/20-5/20 lengths of the catheter of spline 211.

Fig. 2 and 5, fig. 3 and 6, and fig. 4 and 7 are the case of one flexible electrode 212 plus one ring electrode 214, one flexible electrode 212 plus two ring electrodes 214, and one flexible electrode 212 plus 3 ring electrodes 214, respectively. The number of ring electrodes 214 may be selected for different ablation needs: the more the number of the electrodes is, the higher the range and efficiency of the discharge ablation is, and the electrode is suitable for large-area ablation; correspondingly, the smaller the number of the electrodes, the smaller the range of the discharge ablation, the small-area ablation can be realized without damaging other tissues, and the safety is higher.

Further, referring to fig. 10 and 11, the spline 211 is covered with two bendable electrodes, preferably 1/3-3/4 lengths of the catheter covering the spline 211.

This is so that during ablation, the ablation energy system console 110 can address each of the bendable electrodes 212 and ring electrodes 214 on the spline basket 210, and select either adjacent electrodes on the same spline 211 or electrodes on adjacent splines 211 for unipolar and bipolar spark ablation.

In one embodiment, each electrode on the spline basket can be discharged monopolar to the back reference electrode separately for radiofrequency ablation therapy.

Further, an insulated wire is provided in the insulated tube 213, and is connected to the bendable electrode 212, and the insulated wire is connected to an electrical socket of the control handle 331 through the conduit 321 of the main body middle section 132.

The insulating tube 213 is a tube made of flexible polymer insulating material, including but not limited to polyimide, FEP, TPU, Pebax, nylon, and silicone.

Further, the proximal end of the spline basket 210 is connected to the catheter 321 of the main body middle section 132, the push rod 215 is connected between the distal end and the proximal end of the spline basket 210, the push rod 215 is connected to the rotary handle or the push rod of the control handle 331 of the proximal section through the inner tube, and the control handle is used for retracting or extending the spline basket 210.

Furthermore, both ends of the bendable electrode 212 in the spline 211 are fixedly connected with the conduit 321 of the main body middle section 132 through an insulating tube 213.

The materials of the flexible electrode and the ring electrode include, but are not limited to, metal platinum, platinum alloy, gold alloy, copper, stainless steel, nickel-titanium alloy, MP35N, and metal composite structure with X-ray development component, such as non-development bulk composite structure with X-ray development coating.

Electrodes are distributed on the annular catheter 220, wherein the adjacent positive and negative electrodes are combined to perform discharge ablation, so that three-dimensional cylindrical surface ablation is realized, and the discharge ablation effect is maximized.

The guide wire 220 passing through the catheter 321 and the push rod 215 has two shapes, a loop shape and a terminal elbow shape.

In one embodiment, referring to fig. 2-4, the 220 is a ring catheter, which has a large discharge range and a larger ablation area, and is suitable for large-area ablation.

In one embodiment, referring to fig. 5-7, the guide wire 220 is a distal elbow guide wire, which is linear and is convenient for moving and positioning in a blood vessel.

Further, the guide wire 220 extends through the lumen of the push rod 215 of the spline basket 210, and the push rod 215 can be retracted from the catheter 321, thereby controlling the extension of the spline basket 210.

When a plurality of splines 211 are provided, under the condition that the spline basket 210 is opened to form a basket shape, the splines 211 are uniformly distributed on the three-dimensional space by 360 degrees around the straight line where the guide pipe 321 and the push rod 215 are located. The open spline basket 210 has two shapes, a basket-like sphere shape and a petal shape, and also has an intermediate state of three states.

In one embodiment, referring to fig. 2-7, spline basket 210 is in the shape of a basket sphere, which has a larger fitting area, and the electrodes on splines 211 are positively and negatively paired with each other and with the electrodes on the ring catheter to achieve large area ablation by electrical discharge.

In one embodiment, referring to fig. 8-9, spline basket 210 is petal-shaped, and petal-shaped splines 211 are connected at both ends. The petal catheter (fig. 12) without the loop catheter or guide wire 220 is suitable for ablation of non-vascular orifice sites, such as the posterior wall and the top of the atrium, and meets the requirements of continuous atrial fibrillation ablation.

Further, referring to fig. 13a, 13b and 13c, the bendable electrode structure may be a single-strand, double-strand and snap-fit structure. Referring to fig. 13a, the single-stranded bendable electrode is formed by bending a conductive wire into a spring shape, and has a length of 2mm to 20mm and an outer diameter of 2F to 710F; referring to fig. 13b, the bifilar bendable electrode is formed by bending two conductive wires into a spring shape, the length is 2 mm-20 mm, and the outer diameter is 2F-10F; referring to fig. 13c, the flexible electrode with snap structure is formed by connecting annular conductive metal sheets with snap on their edges, and has a length of 2 mm-20 mm and an outer diameter of 2F-10F.

The above description is only a preferred embodiment of the present invention, and it is not intended to limit the scope of the present invention, and various modifications and changes may be made by those skilled in the art. Variations, modifications, substitutions, integrations and parameter changes of the embodiments may be made without departing from the principle and spirit of the invention, by the conventional substitution or by performing the same function within the spirit and principle of the invention.

Claims

1. An ablation catheter system adopting a combined electrode is characterized by comprising an ablation energy system console, a pacing and ECG unit and an ablation catheter, wherein the ablation catheter comprises a proximal section, a main body middle section and a distal section which are sequentially connected; the ablation catheter is connected to an ablation energy system console, and ablation energy is transmitted to the ablation tissue through an electrode on the ablation catheter;

the distal section of the catheter comprises an elastically stretchable splined basket comprising a plurality of extendable splines with a plurality of electrodes, at least one of the plurality of electrodes being a bendable electrode.

2. The ablation catheter system with a combined electrode as claimed in claim 1, wherein the electrode of each spline on said spline basket includes one or more combinations of the following four in the order of arrangement:

1) a flexible electrode and a ring electrode;

2) a flexible electrode and two ring electrodes;

3) one flexible electrode and three ring electrodes;

4) two bendable electrodes.

3. The ablation catheter system adopting the combined electrode as claimed in claim 1, wherein the distal end part of the spline is a bendable electrode sleeved outside the elastic insulation branch pipe, and each electrode selects an electrode of the same spline or an electrode on an adjacent spline to carry out positive and negative pairing so as to realize voltage pulse bipolar discharge ablation; can also be connected with a radio frequency instrument to perform single-stage or multi-stage radio frequency ablation.

4. The ablation catheter system with the combined electrode as claimed in claim 3, wherein the bendable electrode is a stent structure and is formed by an electrode formed by a single wire or a plurality of wires, and the plurality of wires are preferably 2-5;

5. The ablation catheter system with the combined electrode as claimed in claim 2 or 3, wherein the bendable electrode support structure is replaced by a spring structure formed by arranging single or multiple wires or a metal wire mesh structure formed by weaving multiple round or flat wires, wherein each spring or mesh corresponds to one bendable electrode;

the material of the bendable electrode or the ring electrode is metal platinum, platinum alloy, gold alloy, copper, stainless steel, nickel-titanium alloy, MP35N or a metal composite structure with X-ray development components (such as a non-development bulk composite structure with X-ray development coating).

6. The ablation catheter system with a combined electrode of claim 1, wherein the multi-spline structure is in the shape of a basket sphere or a petal after being stretched;

the proximal end of the spline basket is connected to a fixing piece at the middle section of the catheter main body, the fixing piece is connected to a control handle at the proximal section through a pull wire, the spline basket is bent through the control handle, and the spline basket is adjusted to different positions.

7. The ablation catheter system with a combined electrode according to claim 2, wherein the bendable electrode has a length of 2mm to 20mm and an outer diameter of 2F to 10F; the length of the annular electrode is 0.5 mm-5 mm, and the outer diameter is 2F-10F; the distance between adjacent electrodes on the same spline is 0.5 mm-20 mm. Preferably, the length of the bendable electrode is 4 mm-10 mm, and the outer diameter is 2F-7F; the length of the annular electrode is 0.5 mm-3 mm, and the outer diameter is 2F-7F; the distance between adjacent electrodes on the same spline is 0.5 mm-6 mm.

8. The ablation catheter system with a combination electrode of claim 1, wherein the splined basket includes 4-12 splines, preferably 4-8 splines; the spline of the spline basket is composed of an elastic single-cavity tube made of medical polymer materials, and the elastic single-cavity tube with X-ray developer is preferable.

9. The ablation catheter system with a combination electrode of claim 1, wherein the distal section further comprises a ring catheter or guidewire extending through the catheter guidewire lumen to the distal end of the spline basket, the ring catheter having an electrode disposed thereon, the catheter or guidewire being accessible within the vascular lumen.

10. The ablation catheter system with a combination electrode of any of claims 1-9, wherein the electrode fits closely over the splined surface and the proximal end of the electrode is connected to a lead extending to a handle; the guide wire or the annular catheter in the guide wire cavity of the catheter enters the cavity, so that the spline basket is positioned and attached to the cavity opening, and the annular catheter can be used for mapping or ablation by discharging.