CN112754645A

CN112754645A - Ablation catheter device with mapping function

Info

Publication number: CN112754645A
Application number: CN202110029840.0A
Authority: CN
Inventors: 林晨
Original assignee: Anhang Medical Technology Hangzhou Co ltd
Current assignee: Hangzhouready Biological Technology Co ltd
Priority date: 2021-01-11
Filing date: 2021-01-11
Publication date: 2021-05-07

Abstract

The invention relates to an ablation catheter device with a mapping function. The device comprises a handle, a lead, a pulse generating circuit, a surgical control device, a metal flap, a first catheter and a flexible circuit; the first catheter is positioned at the far end of the handle, the far end of the first catheter is movably connected with a second catheter, the second catheter and the first catheter are mutually nested, and the far end of the second catheter is provided with a tube head; the metal flap is in a sheet shape, one end of the metal flap is connected with the first guide pipe, the other end of the metal flap is connected with the second guide pipe, the flexible circuit comprises a non-conductive base material, and the non-conductive base material is fixed on the outer surface of the metal flap; the conducting layer is fixed on the outer surface of the non-conducting substrate; the non-conductive covering material partially covers the outer surface of the conductive layer, and the conductive layer of the uncovered part forms an electrode. The invention has the advantages of better attaching to endocardial tissue, realizing ablation and mapping, reasonable ablation range and angle and convenient operation.

Description

Ablation catheter device with mapping function

Technical Field

The invention relates to a medical instrument, belongs to the technical field of pulse ablation surgery, and particularly relates to an ablation catheter device with a mapping function.

Background

Radio Frequency (RF) ablation and cryoablation are two common methods for treating arrhythmia such as severe atrial fibrillation in clinical practice. The success of ablation depends primarily on whether the ablation range is continuous and sufficient. The damage must be sufficient to destroy the arrhythmogenic tissue or to substantially interfere with or isolate abnormal electrical conduction within the myocardial tissue. Excessive ablation will have an effect on surrounding healthy tissue as well as on nerve tissue. The radiofrequency ablation can reach all positions of the anatomical structures of the heart, is suitable for arrhythmia including atrial fibrillation, atrial flutter, atrial velocity, ventricular premature, ventricular velocity and the like originated from pulmonary veins or non-pulmonary veins, has the defects of longer ablation operation time, higher requirement on the operation level of catheters of operators, pain during ablation due to thermal injury and easy pulmonary vein stenosis after operation. Application of radio frequency energy to target tissue has an effect on non-target tissue, application of radio frequency energy to atrial wall tissue may cause esophageal or phrenic nerve damage, and in addition radio frequency ablation has a risk of tissue scarring, further leading to embolization problems. And in the cryoablation, if the cryoballoon is tightly attached to the pulmonary vein, the annular ablation isolation can be completed once or several times, so that a patient does not feel pain and the operation time is shortened, but the damage rate of the cryoablation on the phrenic nerve is higher, and the method cannot timely confirm whether the ablation isolation is successfully completed, and the epicardial freezing near the coronary artery possibly causes thrombosis and progressive coronary artery stenosis.

Today, pulsed electric field technology is emerging, which applies brief high voltages to tissue cells, and can generate local high electric fields of several hundred volts per centimeter; the local high electric field disrupts the cell membrane by creating pores in the cell membrane where the applied electric field is above the cell threshold such that the pores do not close, and such electroporation is irreversible, thereby allowing biomolecular material to exchange across the membrane, resulting in cell necrosis or apoptosis. The irreversible electroporation of pulse is different from the physical therapy based on the principle of thermal ablation, such as radio frequency, refrigeration, microwave, ultrasound, etc., and the irreversible electroporation damage of microsecond pulse to the myocardial cell membrane is a non-thermal biological effect and can effectively avoid the damage of blood vessels, nerves and other tissues. Because different tissue cells have different threshold values for voltage penetration, the high-voltage pulse technology can be used for selectively treating the myocardial cells (the threshold value is relatively low) without influencing other non-target cell tissues (such as nerves, blood vessels and blood cells), and meanwhile, because the time for releasing energy is extremely short, the pulse technology cannot generate heat effect, so that the problems of tissue scabbing, pulmonary vein stenosis and the like are avoided.

In a similar technology, for example, chinese patent application publication No. CNCN 111248993 a, an irreversible electroporation (IRE) balloon catheter "with a membrane-insulated high-voltage balloon wire is disclosed. A medical probe is provided that includes a shaft and an inflatable balloon. The shaft is configured for insertion into an organ of a patient. The inflatable balloon is coupled to the distal end of the shaft, wherein the inflatable balloon comprises: (a) an inflatable membrane having an outer surface and an inner surface, wherein the inflatable membrane is configured to be inflated from a collapsed shape to a balloon-forming member, (b) a plurality of electrodes disposed on the outer surface of the inflatable membrane, (c) one or more wires connected to the plurality of electrodes, the wires extending from the distal end to the electrodes, (d) and an inflatable cover that encapsulates the wires between the inflatable cover and the inflatable membrane such that the wires are constrained between the cover and the inflatable membrane, but the electrodes are exposed to a surrounding environment.

The invention patent application assembles an inflatable balloon by assembling an inflatable membrane having an outer surface and an inner surface, wherein the inflatable membrane is configured to be inflated from a collapsed shape to a balloon forming member. A plurality of electrodes is disposed on an outer surface of the inflatable membrane. The wires are connected to a plurality of electrodes, and an expandable cover is used to encapsulate the wires between the cover and the expandable membrane such that the wires are constrained between the cover and the expandable membrane, but the electrodes are exposed to the surrounding environment. An inflatable balloon is coupled to the distal end of the shaft. That is, since the wire cannot be directly introduced into the human tissue, the wire is covered with the expandable covering member and the electrode portion is leaked out to perform the impulse ablation operation, but there are disadvantages as follows: 1. the electrodes on the balloon are bonded on the surface of the balloon, and deformation and uneven spacing can be generated in the process of balloon expansion, so that the ablation effect is influenced. 2. The shape of the balloon and the position of the electrodes are not good for eliminating thrombus generated by atrial fibrillation. 3. The balloon and the annular gap of the inflatable covering piece are connected by glue, and the balloon needs to be folded and inflated and has certain pressure, so that the glue is easy to fall off, leak and the like. The hidden danger is very big on the instrument for interventional therapy of human body.

Chinese patent application publication No. CN110662483A, discloses a system, device and method for electroporation ablation therapy, wherein the device includes a set of splines coupled to a catheter for medical ablation therapy. Each spline of the set of splines may include a set of electrodes formed thereon. The set of splines may be configured for translation to transition between a first configuration and a second configuration. Each spline of the set of splines in the second configuration may be petal-shaped.

The ablation device of this patent application may contain one or more catheters, guidewires, balloons, and electrodes. The ablation device can be converted to different configurations (e.g., compact and expanded) that can be transformed into two states by controlling the retraction and retraction of the catheter guidewire. However, in the actual use process, the in-place property of the shape is difficult to control in the in-vivo switching process of the technology, the rigidity of the material and the structure is poor, the orientation and the angle of the electrode cannot be guaranteed, and often in use, one ablation part needs to be rotated for multiple times by an angle, multiple times of ablation is carried out in a trial mode, so that incomplete ablation and ablation omission are avoided. In addition, the technique has the following disadvantages: 1. in the operation process, because the conditions in the heart and the blood vessel are relatively complex, the state of the electrodes formed by the technology is uncertain, the effective and accurate ablation is difficult, and the angle and the position can only be changed by repeatedly rotating, so the ablation effect is greatly reduced. 2. Because the heart is in continuous shrink and diastole, relevant great vessel, also because the inflow of blood flows and is constantly beating, setting up under this scheme two kinds of states is unreasonable, cambered surface tissue such as the left atrium back wall of can not effectively laminating promptly, also can not effectively adapt to annular vascular tissue such as vena cava, and the structure and the columniform electrode design of this petal formula all can receive the influence under practical state, have further reduced and have melted the effect.

Disclosure of Invention

The invention aims to solve the technical problem of providing an ablation catheter device with a mapping function, which has the advantages of reasonable structural design, good adhesion with the tissue and the blood vessel of the inner cardiac wall, capability of marking and measuring the potential of the atrial wall or the pulmonary vein ostium after ablation is finished, decision on whether ablation is successful or not, capability of achieving an ablation position more conveniently due to a light and thin structure, reasonable ablation angle, good ablation pertinence, stable ablation effect and convenience in operation.

The technical scheme adopted by the invention for solving the technical problems is an ablation catheter device with a mapping function, which comprises a handle, a guide wire, a pulse generation circuit and a surgical control device, and is structurally characterized by further comprising a metal flap, a first catheter and a flexible circuit;

the first catheter is positioned at the far end of the handle, is slender and is used for being inserted into an organ lesion part of a patient, the far end of the first catheter is movably connected with a second catheter, the second catheter and the first catheter are mutually nested, and the far end of the second catheter is provided with a tube head;

the metal valve is in a sheet shape, one end of the metal valve is connected with the first conduit, the other end of the metal valve is connected with the second conduit,

the flexible circuit comprises the following components:

A. a non-conductive substrate secured to an outer surface of the metallic lobe;

B. the conducting layer is fixed on the outer surface of the non-conducting substrate;

C. the non-conductive covering material is partially covered on the outer surface of the conductive layer, the conductive layer without being covered by the covering material forms an electrode, and the electrode is connected with the pulse generating circuit through a lead and is used for generating electric pulses for ablating pathological tissues.

The metallic valve that the slice set up, cooperate light and handy flexible circuit, it is more nimble convenient, can form three kinds of states according to the degree of strutting, the shrink form, complete expansion form and partial expansion form, partial expansion form can also select the degree of inflation as required, thereby nimble realization different positions and the ablation needs of the different state of an illness, and, simultaneously can realize the mapping function, can be after melting the completion, the electric potential of mapping atrium wall or pulmonary vein mouth, whether detect to melt successfully, if not melt successfully or melt incompletely, can melt once more, do not need to increase mapping pipe and extra operation in the middle of, the effect and the efficiency of operation have been improved greatly, promote treatment.

In addition, the flexible circuit has a three-layer structure, a plurality of electrodes can be flexibly arranged on the flexible circuit, and the functions of ablation and mapping can be further better realized through the matching of the plurality of electrodes.

The arrangement of the first catheter and the second catheter ensures the expanded shape, is more suitable for the lesion of the heart and related blood vessels, and is more beneficial to reaching the affected part more effectively. The application of the covering material further fixes the flexible circuit, reduces the influence on the stability of the flexible circuit due to the deformation of the metal flap, has firmer position, and plays a role in highlighting the ablation working area, so that the ablation area is more controllable and has outstanding effect. Covering materials can be arranged on one flexible circuit in a segmented mode, and an ablation area formed between electrodes is flexible and variable.

In addition, the design of the section can not obstruct the unobstructed blood flow. The blood flowing speed in the heart is high and is not stopped at all, if the blood flowing is not smooth, great negative effects can be generated, and the smooth operation is influenced.

Further, the metal petals are made of elastic metal, and the tail ends of the metal petals are combined into a whole to form a circular ring shape.

Typically a sheet metal such as nitinol.

Furthermore, the half part of the metal flap close to the tube head is provided with an easy-to-fold part which is locally thinned to form a thin part or locally hollowed to form a hollowed-out part.

Due to the design of the easy-to-fold part, when the spreading state is adjusted, the metal flap can be stably bent at the easy-to-fold part, so that a stable and expected shape is formed, the shape of the whole working part is easier to control, and ablation and mapping of different parts are better performed.

The design of the frangible portion is such that after full expansion the front end is flattened, somewhat resembling the shape of a pumpkin, in order to allow a larger ablation area to be formed at the front end, while allowing an ablation area to be formed at the side. Better eliminates the focus of atrial fibrillation. The flexible circuit can be attached to the tissue of the pulmonary vein opening for ablation, and can also be attached to the wall of the cambered tissue such as the rear wall of the left atrium for ablation. The surface electrode of the metal valve in a partial expansion state can perform ablation or mapping on annular blood vessel structures such as vena cava and the like.

Furthermore, the first catheter of the invention is composed of a first catheter and a second catheter, the second catheter is coaxially arranged in the first catheter, the distal end of the second catheter is provided with a soft catheter head, and the balloon is respectively connected with the soft catheter head and the edge of the first catheter.

Further, the first catheter is telescopic in length, the second catheter is coaxially arranged in the first catheter, and the distal end of the second catheter is provided with a catheter soft head.

The first catheters which are nested with each other are designed, the expansion shape is ingeniously controlled, meanwhile, the soft heads of the catheters are matched, the heart focus can be reached more conveniently, fine adjustment can be carried out on an ablation area in the use process, and therefore a better ablation effect is achieved.

The second catheter can also be sleeved outside the first catheter, and the second catheter can move back and forth relative to the far end of the first catheter, so that the metal flaps fixed at the far ends of the second catheter and the first catheter are respectively unfolded to form a working state.

Furthermore, the number of the metal valves is 4-12, and the size and the shape of the expanded metal valves are adaptive to the size and the shape of the pulmonary vein orifice or the atrial wall; the metal petals are uniformly distributed on the angle of the circumference.

The evenly distributed metal petals can form a stable and balanced ablation and mapping area, so that the ablation and mapping effects can be better controlled.

Furthermore, the handle is provided with a catheter bidirectional bending adjusting ring, the catheter bidirectional bending adjusting ring is connected with a guide wire which is arranged in the first catheter and fixedly connected to the far end of the first catheter, bending deflection of the far end of the first catheter is controlled, and the bending deflection of the far end of the first catheter drives the metal valve to deflect left and right.

The left and right deflection of the metal valve further increases the flexibility and range of ablation and mapping, and further enhances the effect of ablation and mapping, thereby further improving the effect of the operation.

Furthermore, the handle is also provided with a second catheter sliding adjusting block, and the second catheter sliding adjusting block is directly connected with the second catheter through a guide wire arranged in the first catheter.

The second guide pipe slides the setting of adjusting block for the control of second guide pipe is more convenient, thereby the degree that more accurate, nimble control flap struts.

Furthermore, the conducting layer on each metal lobe is respectively connected with the pulse generating circuit which is independently controlled through different conducting wires.

By controlling the polarity of the conducting layers on each metal lobe, a variable ablation and mapping area can be flexibly formed, and better ablation and mapping effects are realized. By matching with the sectional design of the covering material and the application of a plurality of flexible circuits, different ablation ranges can be flexibly formed so as to meet the actual requirements of the operation.

Further, the number of the electrodes on each metal petal is 2-8, and the electrodes protrude out of the non-conductive covering material.

The electrode is projected outwards, so that the ablation can be further effectively realized, and the ablation effect is improved.

Furthermore, the material of the non-conductive covering material and the material of the non-conductive base material are both biocompatible materials. Such as polyethylene terephthalate (PET), Polyimide (PI), and the like.

Compared with the prior art, the invention has the following advantages and effects:

1. the sheet-shaped design of the metal flaps is matched with the multi-electrode design of the flexible circuit, so that the dual functions of ablation and mapping can be realized, the two functions can be switched at will, the surface flexible circuit on the metal basket formed by the metal flaps is composed of a plurality of independent electrodes in the practical operation application process, the potential mapping can be timely carried out after ablation is completed to observe whether ablation is successful, and if the ablation is unsuccessful, re-ablation can be carried out immediately. The effect and the efficiency of the operation are greatly improved, so that the ablation effect is greatly improved.

2. The first catheter and the second catheter are matched, so that the shape of the metal valve is guaranteed, the medical catheter is more suitable for different pathological changes of the heart and related blood vessels, and the medical catheter is more favorable for being more effectively contracted to reach an affected part. The first catheters which are nested with each other are designed, the expansion shape is ingeniously controlled, meanwhile, the soft head of the catheter is matched, the heart focus can be reached more conveniently, fine adjustment can be carried out on an ablation area in the using process, and a better ablation effect is achieved. Through each controlling means who sets up on the brake valve lever, still make inflation degree and process more controllable, the retentivity of inflation shape is better to and the angle of rotation about adjusting the lamella, thereby in the in-service use process, the inflation and the location work that get into the affected part are more reliable.

3. The design of the frangible portion, which is flat at the front end after expansion, forms a metal basket somewhat resembling a pumpkin in shape, in order to allow a larger ablation area to be formed at the front end, while allowing an ablation area to be formed at the side. Better eliminates the focus of atrial fibrillation. Meanwhile, in a partial expansion state, the electrode on the surface of the metal valve can perform ablation or mapping on annular blood vessel structures such as vena cava and the like. The flexibility and adaptability of practical use are increased. In a word, the outline design of the expandable metal basket and the arrangement design of the flexible circuit enable the flexible circuit to be well attached to and ablated on the pulmonary vein opening and tissues, enable the electrodes to be attached to and ablated on arc-shaped tissue walls such as the rear wall of the left atrium and the like, and simultaneously enable the upper and lower venae cavae to be ablated in an annular structure. Achieves the purpose that one electrode catheter can carry out pulsed electric field ablation on structures with various structural shapes

4. The design of the expandable metal basket and the flexible circuit provides flexible, non-invasive and sufficient electrode fit with the endocardium, and the electric pulse energy is safely and effectively delivered to a specific target area. Meanwhile, the interference to blood flow can be reduced as little as possible, and the influence of the blood flow on ablation and mapping is avoided while the safety is improved.

5. The flexible design of the flexible circuit, the leaked electrodes are covered in a segmented mode, and the ablation area is more flexibly arranged by matching the number and the positions of the flexible circuits, so that a better operation effect is achieved. The electrode of the flexible circuit is projected outwards, so that the ablation effect can be further improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

FIG. 1 is a schematic view of the overall structure of embodiment 1 of the present invention;

FIG. 2 is a schematic diagram of the structure of a metallic flap and a flexible circuit according to example 1 of the present invention;

FIG. 3 is another angle structure diagram of FIG. 2;

FIG. 4 is a schematic structural view of a metallic lobe;

FIG. 5 is another schematic view of the metallic lobe;

FIG. 6 is a schematic diagram of a flex circuit;

FIG. 7 is a schematic view of FIG. 6 taken along line A;

FIG. 8 is a schematic diagram of a partially expanded configuration of the metallic petals and the flexible circuit;

FIG. 9 is a schematic representation of the operation of ablation of tissue at the ostium of a pulmonary vein;

FIG. 10 is a schematic representation of the operation of ablation of posterior wall tissue in the left atrium;

FIG. 11 is a schematic view of the operation of ablation in vena cava tissue;

description of reference numerals: the device comprises a first catheter 1, a metal basket 2, a second catheter 12, a tube head 121, a sheath 13, a metal flap 21, a thin part 22, a hollow part 23, a flexible circuit 3, a non-conductive substrate 31, a conductive layer 32, a non-conductive covering material 33, an electrode 34, a handle 41, a catheter bidirectional bending ring 42, a second catheter sliding adjusting block 43, a guide wire cavity 44, an input and output lead 45, a pulmonary vein orifice 51, a left atrium rear wall 52 and a vena cava 53.

Detailed Description

The present invention will be described in further detail with reference to examples, which are illustrative of the present invention and are not to be construed as being limited thereto.

Example 1:

as shown in fig. 1 to 8, the present embodiment describes an ablation catheter device with a mapping function, which belongs to the technical field of an impulse ablation operation, and is used for performing an electrical impulse ablation operation treatment on diseased tissue in an interventional human body blood vessel. The device may also map the relevant tissue during treatment. The structure of the device is as follows:

the ablation catheter device with mapping function of the embodiment is composed of the following components: a handle 41 for holding, on which a bidirectional adjusting ring 42, a second catheter sliding adjusting block 43, a pulse generating circuit, a guide wire cavity 44 and an input/output lead 45 are arranged; the distal end of the handle 41 is provided with an elongated first catheter tube 1, the distal end of the first catheter tube 1 is embedded with a second catheter tube 12, and the distal end of the second catheter tube 12 is provided with a catheter head 121. The second guide tube 12 is arranged in the first guide tube 1, the distal end of the second guide tube 12 extends out of the distal end of the first guide tube 1, and the second guide tube 12 can slide in the first guide tube along the axial direction. The first catheter 1 and the second catheter 12 are respectively connected to an expandable metal basket 2, and a plurality of flexible circuits 3 are disposed on the metal basket 2.

The expandable metal basket 2 is a multi-petal structure, that is, the metal basket 2 is composed of a plurality of sheet-shaped metal petals 21, in the embodiment, six metal petals 21 are uniformly distributed in the circumferential direction, and each metal petal 21 has the same shape. Of course, 4-10 metal petals 21 can be provided according to the specific ablation mapping range requirement, the shapes of different metal petals 21 can be changed, and even the metal petals 21 are uniformly arranged in the circumferential direction.

The distal end of the first catheter 1 is connected with one end of the metal flap 21, and the other end of the metal flap 21 is connected with the distal end of the second catheter 12, wherein the connection mode can be bonding, or other connection modes such as embedding, welding or clamping connection and the like can also be adopted. Each petal 21 has a frangible portion near the distal end of the second catheter, which is such that when the metal basket 2 is forced open, the petals 21 are deformed away from the frangible portion. Thereby ensuring that the shape after deformation is controllable. Generally at the location where the petals 21 are adjacent to the tip 121, which is relatively easy to shape for ablation, in this embodiment the frangible portion is partially narrowed to form a thin portion 22. Or a hollowed-out structure is adopted to form a hollowed-out part 23 (fig. 3 and 4), and the narrowed or hollowed-out thin part 22 or the hollowed-out part 23 can enable the metal flap 21 to be bent and deformed, and the main bending and deformation place is the part of the easy-to-fold part, so that the effect of approximate hinge connection is achieved. Of course, the frangible portion may take other forms, such as being locally thinned, or locally being of a different material, or locally being provided with a special metal finish.

Each lobe 21 has an insulating coating on its surface, typically Parylene or PTFE. Flexible circuits 3 are provided on the outer surface of each of the metal petals 21, each of the flexible circuits 3 is provided with a flexible non-conductive substrate 31 on the innermost layer, a conductive layer 32 in the middle, and a non-conductive cover material 33 on the outer layer, covering the conductive layer 32 and partially exposed to form a plurality of electrodes 34. In this embodiment the electrode 34 is shaped to protrude from the non-conductive covering material 33 for better pulsed discharge. Input-output conductors 45 connect the conductive layer 32 to the pulse generating circuitry.

A guide wire cavity 44 is arranged in the handle 1, the guide wire cavity 44 is connected with a cavity in the first catheter 1, a guide wire is arranged in the guide wire cavity, the far end of the first catheter 1 is controlled by the catheter bidirectional bending adjusting ring 42 through a linked guide wire or a fixing clamp, and the metal flap 21 is driven by the bending deflection of the far end of the first catheter 1 to move, so that the left and right deflection of the flexible circuit 3 is realized, and the metal basket 2, the flexible circuit 3 and tissues are attached more accurately; here, the catheter bi-directional adjustment ring 42 may also control twisting the second catheter tube 12 to deflect the metal flap 21, or may control twisting the first catheter tube 1 and the second catheter tube 12 simultaneously to deflect the metal flap 21. The guide wire cavity 44 is communicated with the inner cavity of the second catheter 12, and the second catheter sliding adjusting block 43 pulls the second catheter 12 to move in the cavity of the first catheter 1 along the axial direction through the guide wire, so that the expandable metal basket 2 changes the shape of the outer contour, and the flexible circuit 3 on the metal basket 2 is attached to tissues of different positions and different shapes for ablation or attachment and mapping. The catheter bidirectional adjusting ring 42 and the second catheter sliding adjusting block 43 together form a surgical control device.

The device comprises a first catheter 1, a metal basket 2, a second catheter 12, a tube head 121, a sheath 13, a metal flap 21, a thin part 22, a hollow part 23, a flexible circuit 3, a non-conductive substrate 31, a conductive layer 32, a non-conductive covering material 33, an electrode 34, a handle 41, a catheter bidirectional bending ring 42, a second catheter sliding adjusting block 43, a guide wire cavity 44, an input and output lead 45, a pulmonary vein orifice 51, a left atrium rear wall 52 and a vena cava 53.

When the operation is performed, the second guide tube 12 is moved away from the first guide tube 1 by adjusting the second guide tube sliding adjusting block 43, the metallic flap 21 and the flexible circuit 3 are straightened, and the metallic basket 2 is adjusted to a contracted state, that is, the metallic basket 2 has a tubular shape similar to that of the first guide tube 1. The metal basket 2 is then advanced through the first catheter 1 and handle 41 into the blood vessel to the ablation mapping region.

By moving the position of the second conduit 12, the metal basket 2 can be brought into three states, a contracted state and a fully expanded state and a partially expanded state. The distal end of the first catheter 1 is expanded from a collapsed state to a fully expanded state (fig. 3) or a partially expanded state (fig. 8) after entering a specific heart site. The shape of the outline of the metal basket 2 determines the contact shape of the flexible circuit 3 and the tissue, and when the outline of the metal basket is formed, the metal basket is in a fully expanded state and is approximately oblate sphere shape, so that the flexible electrode can be attached to and ablated by lung vein ostial tissue 51 and cambered tissue walls such as a posterior wall 52 of the left atrium (see fig. 9 and 10). The partially expanded metal basket 2 surface electrodes 34 may ablate or map annular vascular structures such as vena cava 53 (fig. 11).

The mapping can be carried out firstly, tissue ablation operation is carried out according to the mapping condition, the tissue ablation operation can be carried out to a certain degree, mapping can be carried out again, and then the ablation intensity, position and angle are adjusted according to the mapping result. The operation is achieved by the way of circulating and reciprocating.

Material of expandable metal basket 2: made of a resilient metal such as nitinol.

Non-conductive substrate 31: made of a biocompatible material, for example a plastic such as polyethylene terephthalate (PET), Polyimide (PI).

Conductive layer 32: deposited from suitable metals including gold, titanium, copper, etc. by sputtering, electroplating or electroless plating.

Non-conductive covering material 33: made of a biocompatible material, for example a plastic, such as polyethylene terephthalate (PET), Polyimide (PI) or the like.

In addition, it should be noted that the specific embodiments described in the present specification may differ in the shape of the components, the names of the components, and the like. All equivalent or simple changes of the structure, the characteristics and the principle of the invention which are described in the patent conception of the invention are included in the protection scope of the patent of the invention. Various modifications, additions and substitutions for the specific embodiments described may be made by those skilled in the art without departing from the scope of the invention as defined in the accompanying claims.

Claims

1. An ablation catheter device with a mapping function comprises a handle, a guide wire, a pulse generation circuit and a surgical control device, and is characterized by further comprising a metal flap, a first catheter and a flexible circuit;

the flexible circuit comprises the following components:

A. a non-conductive substrate secured to an outer surface of the metallic lobe;

2. The ablation catheter device with mapping function of claim 1, wherein: the metal petals are made of elastic metal, and the tail ends of the metal petals are combined into a whole to form a circular ring.

3. The ablation catheter device with mapping function of claim 1, wherein: the half part of the metal valve close to the tube head is provided with an easy-to-fold part which is locally thinned to form a thin part or locally hollowed to form a hollow part.

4. The ablation catheter device with mapping function of claim 1, wherein: the first catheter is telescopic in length, the second catheter is coaxially arranged in the first catheter, and a catheter soft head is arranged at the far end of the second catheter.

5. The ablation catheter device with mapping function of claim 1, wherein: the number of the metal valves is 4-12, and the size and the shape of the metal valves after being expanded are matched with those of the pulmonary vein orifice or the atrial wall; the metal petals are uniformly distributed on the angle of the circumference.

6. The ablation catheter device with mapping function of claim 2, wherein: the handle is provided with a catheter bidirectional adjusting bending ring, the catheter bidirectional adjusting bending ring is connected with a guide wire which is arranged in the first catheter and fixedly connected to the far end of the first catheter, bending deflection of the far end of the first catheter is controlled, and the bending deflection of the far end of the first catheter drives the metal valve to deflect left and right.

7. The ablation catheter device with mapping function of claim 4, wherein: the handle is also internally provided with a second catheter sliding adjusting block, and the second catheter sliding adjusting block is directly connected with the second catheter through a guide wire arranged in the first catheter.

8. The ablation catheter device with mapping function according to any one of claims 2-7, wherein: the conducting layer on each metal lobe is respectively connected with an independently controlled pulse generating circuit through different conducting wires.

9. The ablation catheter device with mapping function according to any one of claims 2-7, wherein: the number of the electrodes on each metal lobe is 2-8, and the electrodes protrude out of the non-conductive covering material.

10. The ablation catheter device with mapping function of claim 7, wherein: the material of the non-conductive covering material and the material of the non-conductive base material are both biocompatible materials.