CN217886192U

CN217886192U - Radio frequency pulse electric field dual-mode ablation catheter

Info

Publication number: CN217886192U
Application number: CN202221214044.0U
Authority: CN
Inventors: 沈学红; 朱晓林; 高进年; 邹波; 李楚武
Original assignee: Sichuan Jinjiang Electronic Medical Device Technology Co ltd
Current assignee: Sichuan Jinjiang Electronic Medical Device Technology Co ltd
Priority date: 2022-05-20
Filing date: 2022-05-20
Publication date: 2022-11-25
Anticipated expiration: 2032-05-20

Abstract

The utility model relates to a medical instrument, in particular to double mode ablation catheter of radio frequency pulse electric field, including first body, second body and the control mechanism that sets gradually, control mechanism one end and set up the connector, first body passes through control mechanism adjustment bending shape, first body tip sets up first electrode, arrange a plurality of second electrodes that distribute on the first body, all electrodes with the connector is connected, the connector can melt appearance and pulsed electric field ablation appearance adaptation connection with the radio frequency respectively. The catheter has a radio frequency ablation function or a pulse electric field ablation function, so that a more complex ablation operation can be completed without switching the catheter and an operation mode clinically, meanwhile, the first electrode and the plurality of second electrodes can independently acquire electrophysiological signals and discharge between the electrodes for realizing mapping and ablation in or near blood vessels, and multiple functions are selectively set to meet different requirements clinically.

Description

Radio frequency pulse electric field dual-mode ablation catheter

Technical Field

The utility model relates to a medical appliance, in particular to a radio frequency pulse electric field double-mode ablation catheter.

Background

In the catheter ablation treatment means for arrhythmia, the ablation depth of the traditional radio frequency ablation is deep, so that the lesion tissue can be completely necrotized and treated thoroughly, but the required ablation time is long, the catheter is required to be well attached to the ablation site, the tissue is not specifically selected, the ablation process cannot avoid the damage to extracellular matrix and adjacent unrelated tissue, and in some cases, if the lesion site is close to the vascular tissue, the vascular tissue is easily damaged by using a radio frequency ablation mode, so that the vascular stenosis is caused, and when the ablation site is close to a coronary artery, the myocardial infarction is even easily caused.

The high-voltage pulse electric field ablation can selectively damage myocardial cells with lower voltage threshold, but not vascular smooth muscle cells with higher voltage threshold, is suitable for intravascular ablation, and has two conditions: one is the inherent presence of conductive tissue within the vessel that requires ablation, for example, pulmonary vein isolation and Marshall vein ablation; secondly, the lesion is close to the blood vessel and cannot be ablated effectively through other paths, and energy needs to be transferred to the lesion by taking the blood vessel as a path, for example, ablation of the lesion close to the epicardium of the heart. However, the pulse electric field ablation is interelectrode discharge, the energy is dispersed, the ablation depth is shallow, the size of the existing pulse electric field ablation catheter is large, small blood vessels on the surface of the heart are difficult to pass through, particularly, the existing catheter is difficult to realize complete ablation clinically aiming at the special anatomical position and tissue structure of Marshall veins, the absolute ethyl alcohol chemical ablation mode is mostly used for ablation clinically, but the chemical ablation operation is difficult, the control on the absolute ethyl alcohol dose and the ablation time is strict, the tissue permeability of the absolute ethyl alcohol is strong, and the injury to surrounding unrelated tissues can be caused.

In combination with the above, the existing ablation modes have advantages and disadvantages, and for some complicated lesions, the combination of multiple ablation modes is needed, so that the operation difficulty and the economic burden of patients are increased, and the Marshall intravenous complete ablation is difficult to realize by the existing catheter technology.

Therefore, there is a need for a technical solution to solve the technical problems of the existing ablation catheter that the energy used is single, and for some complicated lesions, the ablation cannot be performed more thoroughly, which increases the difficulty of the operation and the economic burden of the patient.

Disclosure of Invention

The utility model aims to provide an: aiming at the technical problems that the existing ablation catheter has single energy and can not ablate more thoroughly for some complicated focuses, thereby increasing the operation difficulty and the economic burden of patients, the radio frequency pulse electric field dual-mode ablation catheter is provided.

In order to realize the purpose, the utility model discloses a technical scheme be:

the utility model provides a radio frequency pulse electric field dual mode ablation catheter, includes the first body, second body and the control mechanism that set gradually, control mechanism one end and set up the connector, first body passes through control mechanism adjustment bending shape, first body tip sets up first electrode, a plurality of second electrodes of range distribution on the first body, all electrodes with the connector is connected, the connector can respectively with radio frequency ablation appearance and pulsed electric field ablation appearance adaptation connection.

The utility model discloses a double mode pipe that melts of radio frequency pulse electric field, the connector setting is in the one end that control mechanism is close to the operation operator, can be selective be connected with radio frequency ablation appearance or pulse electric field ablation appearance, so that the pipe possesses radio frequency ablation function or pulse electric field ablation function, make and can not need to switch over pipe and operation mode clinically, accomplish the operation of melting more complicacy, and simultaneously, first electrode and a plurality of second electrode can carry out electrophysiological signal's collection and electrode discharge alone, a mapping and ablation near for realizing in the blood vessel or blood vessel, multiple functions's selection sets up, in order to adapt to clinical different demands.

As a preferable scheme of the present invention, the first tube body comprises a distal end section and a proximal end section, the length of the distal end section is 10-30mm, and the length of the proximal end section is 80-150mm; the tip section compliance is less than the proximal section compliance; the end section and the proximal section form an included angle alpha, and the alpha is 5-30 degrees. The end is the end that the ablation catheter is close to the position of waiting to ablate, and the near-end is the end that is close to the operation operator, through reducing the terminal section compliance, and keep certain contained angle with the near-end section, the near-end section can provide support and good torque transmission for the terminal section, makes when the ablation catheter uses, through rotatory control mechanism, can transmit the torsion to first body from the second body, makes terminal section and target branch blood vessel entry align, is convenient for the terminal section to get into the blood vessel branch under the condition of not having the guide wire, accomplishes ablation and the mark and map in the tiny blood vessel.

As a preferable scheme of the utility model, the outer diameter of the first pipe body is 3F-7F; the tip section outer diameter is smaller than the proximal section outer diameter. The end section is made smaller, and the small blood vessel branch can be more easily accessed.

As a preferred aspect of the present invention, the end section is arc-shaped, the included angle α is formed between an arc tangent of the end section and the proximal section, a traction structure is disposed in the proximal section, and the control mechanism controls the bent shape of the first pipe body through the traction structure. The inner space of the proximal section is larger than that of the distal section, and a traction structure can be arranged to be connected with the control mechanism, so that deflection control of the first pipe body is realized.

The utility model discloses a double mode pipe that melts of radio frequency pulse electric field can melt and Marshall intravenous freely switches over between melting in conventional heart, and tiny and the first body that can control easily get into coronary sinus after, more tiny end section can continue to go deep into and reach Marshall vein mouth, through controlling the rotatory first body of mechanism, the arc structure at end section makes the pipe can get into Marshall intravenous under the guide wire condition of nothing smoothly, accomplishes Marshall intravenous and melts.

As a preferable aspect of the present invention, the electrodes on the distal end section and the proximal end section are sequentially numbered, respectively, and the electrode surface areas of the odd-numbered positions of the distal end section or the proximal end section are the same, the electrode surface areas of the even-numbered positions are the same, and the electrode surface areas of the odd-numbered positions and the even-numbered positions are the same or different. The surface area ratio between the discharge electrodes is related to the energy concentration degree, the larger the surface area ratio between the discharge electrodes is, the more concentrated the energy of the electrode on the side with smaller surface area is, and the deeper the ablation depth is, taking the discharge of the electrode A to the electrode B as an example, the surface area ratio between the discharge electrodes is the ratio of the surface area of the electrode A to the surface area of the electrode B, the upper electrodes of the end section and the proximal section are respectively structurally limited, so that the upper electrodes of the end section and the proximal section are relatively independent, and the ablation in the corresponding area can be independently completed.

As a preferred embodiment of the present invention, when the diameters of the distal end section and the proximal end section are the same, all the electrodes on the first tube are sequentially numbered.

As the preferred scheme of the utility model, the first electrode discharges alone and carries out some ablation, or, all electrodes cooperation discharge and form linear ablation area, or, all electrodes carry out electrophysiological signal collection.

As a preferable scheme of the utility model, when in linear ablation, the adjacent electrodes discharge, or a plurality of electrodes discharge to a single electrode, or a plurality of electrodes discharge to a plurality of electrodes; the ratio of the surface area of the discharge electrode is 1-20. The electrodes can simultaneously have an electrophysiological mapping function, and can map the potential of an external heart mould or a left ventricle through coronary veins.

In a preferred embodiment of the present invention, the ratio of the surface areas of the discharge electrodes is 1 to 3.

As the preferred scheme of the utility model, the second electrode is platinum iridium alloy electrode, wire electrode or other flexible electrodes, second electrode width 0.5-4.0mm, and is adjacent second electrode interval 1-10mm, it is adjacent the interval size of second electrode becomes the inverse correlation with the detection precision, becomes positive correlation with the detection range. The distance between the adjacent second electrodes is adjusted according to the actual use requirement, and the smaller the distance is, the higher the detection precision of the electric potential is, but the smaller the range capable of detecting the electric potential is.

As the preferred scheme of the utility model, adjacent second electrode interval 1-4mm. Enabling a continuous ablation band to be produced when linear ablation is applied.

As the preferred scheme of the utility model, when the second electrode is the wire winding electrode, be in through the wire coiling make on the first body, wire diameter 0.01-0.5mm, coiling pitch 0-2mm, under the same line footpath, coiling density, electrode unit width are surface area, electrode rigidity down and are positive correlation. Compared with the common electrode, the wire-wound electrode can achieve a larger surface area under the same width, so that the catheter achieves an ideal electrode surface area ratio and a continuous ablation band, has better flexibility and compliance, can realize mapping and ablation in or near a blood vessel, particularly in the depth of a coronary vein, and has the advantages that the more dense winding under the same wire diameter is, the larger the surface area of the electrode under the unit width is, the larger the electrode rigidity is, and vice versa.

As the preferred scheme of the utility model, all electrodes with set up temperature sensor between the first body. The first electrode is arranged at the end part of the first tube body, the second electrode is arranged on the outer surface of the first tube body, and the temperature sensors are arranged between all the electrodes and the first tube body and used for detecting the temperature during radio frequency ablation.

As the utility model discloses a preferred scheme, first body sets up terminal positioning sensor and near-end positioning sensor at least, terminal positioning sensor sets up first electrode with between the first body, near-end positioning sensor sets up first body with between the second body. And displaying the position and the shape of the first tube body in the cardiac electrophysiology three-dimensional mapping system.

As a preferable aspect of the present invention, an intermediate positioning sensor is disposed between the distal end section and the proximal end section. The display of the position and the shape of the catheter is more accurate.

As the utility model discloses a preferred scheme, positioning sensor is magnetism positioning sensor, optic fibre positioning sensor or electronic tags, and positioning sensor and electrode are mutual insulation. The good insulation arrangement can avoid the distortion of the position and the shape display of the catheter in the ablation process.

To sum up, owing to adopted above-mentioned technical scheme, the beneficial effects of the utility model are that:

1. the utility model discloses a double-mode ablation catheter for radio frequency pulsed electric field, the connector is arranged at one end of the control mechanism close to an operator, and can be selectively connected with a radio frequency ablation instrument or a pulsed electric field ablation instrument, so that the catheter has the radio frequency ablation function or the pulsed electric field ablation function, and the complicated ablation operation can be completed without switching the catheter and the operation mode clinically;

2. the utility model discloses a dual-mode ablation catheter of radio frequency pulse electric field, the first electrode and a plurality of second electrodes can independently carry out the collection of electrophysiological signals and discharge between the electrodes for the mark survey and ablation in or near the blood vessel are realized, and the selection setting of multiple functions is to adapt to different clinical requirements;

3. the utility model discloses a double mode ablation catheter of radio frequency pulse electric field, near-end section can provide support and good moment of torsion transmission for the end section, makes when ablating the catheter and using, through rotatory control mechanism, can transmit torsion from the second body to the first body, makes the end section align with target branch blood vessel entry, is convenient for the end section to get into the blood vessel branch under the condition of not having the guide wire, accomplishes melting and mark survey in the tiny blood vessel;

4; the utility model discloses a radio frequency pulse electric field dual mode ablation catheter can freely switch between ablation and Marshall intravenous ablation in conventional heart, and after the tiny and controllable first body can easily get into coronary sinus, the more tiny end section can continue to go deep to reach Marshall venous orifice, and through the rotatory first body of control mechanism, the arc structure of end section makes the catheter can get into Marshall intravenous smoothly under the condition of no guide seal wire, accomplishes Marshall intravenous ablation;

5. the utility model discloses a double mode pipe that melts of radio frequency pulse electric field through adopting wire winding electrode, compares in ordinary electrode, can reach bigger surface area under the same width, not only makes the pipe reach the electrode surface area ratio of ideal and melts the area in succession, has better compliance and compliance moreover, can realize in the blood vessel or near vascular mark survey and melt, especially mark survey and melt in the deep department of coronary vein.

Drawings

Fig. 1 is a schematic structural view of a rf pulsed electric field bimodal ablation catheter of the present invention;

fig. 2 is a first schematic structural view of the first tube according to embodiment 1;

fig. 3 is a second schematic structural view of the first tube in embodiment 1;

FIG. 4 is a first schematic view showing the distribution of the electric field for discharge between electrodes in example 2;

FIG. 5 is a second schematic view showing the distribution of the discharge electric field between the electrodes in example 2;

FIG. 6 is a third schematic view showing the distribution of the electric field in the discharge between the electrodes in example 2;

FIG. 7 is a fourth schematic view showing the distribution of the discharge electric field between the electrodes in example 2.

An icon:

the probe comprises a first tube body 1, a tail end section 11, a proximal end section 12, a second tube body 2, a control mechanism 3, a connector 4, a first electrode 5, a second electrode 6, a second electrode 61, a third electrode 62, a fourth electrode 63, a fifth electrode 64, a sixth electrode 65, a tail end positioning sensor 7, a middle positioning sensor 8 and a proximal end positioning sensor 9.

Detailed Description

The present invention will be described in detail with reference to the accompanying drawings.

In order to make the objects, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the invention.

Example 1

As shown in fig. 1, the rf pulsed electric field bimodal ablation catheter includes a first tube 1, a second tube 2 and an operating mechanism 3, which are sequentially arranged, a connector 4 is arranged at one end of the operating mechanism 3, the first tube 1 is curved by the operating mechanism 3, a first electrode 5 is arranged at an end of the first tube 1, a plurality of second electrodes 6 are distributed on the first tube 1, all the electrodes are connected with the connector 4 through wires, the connector 4 can be connected with an rf ablation instrument and a pulsed electric field ablation instrument through a matching cable, the first tube 1 includes a distal end section 11 and a proximal end section 12, and the distal end section 11 is arc-shaped in a free state.

Specifically, the first tube 1 is a flexible bendable section, as shown in fig. 2, the first tube 1 may be composed of a tube with a same diameter, as shown in fig. 3, the first tube 1 may also be assembled by two tubes with different diameters, and this embodiment is described by taking an example that the first tube 1 is composed of two tubes with different diameters, namely, a terminal section 11 and a proximal section 12:

as shown in fig. 3, the diameter of the end section 11 is smaller than that of the proximal section 12, the flexibility of the end section 11 is smaller than that of the proximal section 12, an included angle α is formed between an arc tangent of the end section 11 and the proximal section 12, the α is 5-30 °, and a traction structure is arranged in the proximal section 12 and is connected with the control mechanism 3.

In particular, the end section 11 is curved by providing an internal support or heat-shaping into a fixed shape.

Specifically, the length of the end section 11 is 10-30mm, and the length of the proximal section 12 is 80-150mm, so as to ensure that the pipe body reaches a sufficient depth.

Specifically, the first tube 1 is provided with a distal positioning sensor 7, a middle positioning sensor 8 and a proximal positioning sensor 9, the distal positioning sensor 7 is arranged between the first electrode 5 and the first tube 1, the proximal positioning sensor 9 is arranged between the first tube 1 and the second tube 2, and the middle positioning sensor 8 is arranged between the distal section 11 and the proximal section 12.

When the cardiac electrophysiology three-dimensional mapping system is used, the position and the form of the first tube body 1 are accurately displayed in the cardiac electrophysiology three-dimensional mapping system through the positioning sensors, good torque transmission is provided for the tail end section 11 through the traction structure arranged in the near end section 12, when the control mechanism 3 rotates, the torque transmission is transmitted to the first tube body 1 through the second tube body 2, the deflection control of the first tube body 1 is realized, the first electrode 5 is controlled to reach a specified position, the first tube body 1 smoothly enters an accurate blood vessel, electrophysiological signals are collected through the electrodes distributed on the first tube body 1, and radiofrequency ablation or high-voltage pulse electric field ablation is carried out.

The radiofrequency pulse electric field dual-mode ablation catheter can be selectively connected with a radiofrequency ablation instrument or a pulse electric field ablation instrument, so that the catheter has a radiofrequency ablation function or a pulse electric field ablation function, the catheter and an operation mode do not need to be switched clinically, a complex ablation operation is completed, and the defects that the prior catheter is single in energy and cannot completely ablate some complex focuses are overcome.

According to the radiofrequency pulse electric field dual-mode ablation catheter, the first electrodes 5 and the second electrodes 6 can independently acquire electrophysiological signals and discharge electricity among the electrodes, mapping and ablation in or near blood vessels are achieved, particularly, mapping and ablation are performed at the deep part of coronary veins, and the mapping and ablation functions are achieved at the same time, so that different clinical requirements can be met.

According to the radiofrequency pulse electric field dual-mode ablation catheter, the two-section combined structure of the first tube body 1 and the arc-shaped arrangement of the end section 11 enable the first tube body 1 to be aligned with a target branch blood vessel entrance and enter a blood vessel branch under the condition of no guide wire, and can be closer to a part to be ablated.

The radio-frequency pulse electric field dual-mode ablation catheter can be used for Marshall intravenous ablation, free switching between conventional intracardiac ablation and Marshall intravenous ablation can be achieved, when the catheter is used, after a small and controllable first tube body 1 easily enters a coronary sinus, a smaller end section 11 can continuously and deeply reach a Marshall vein opening, then the torsion is transmitted to the first tube body 1 through a rotating control mechanism 3 through a second tube body 2, the first electrode 5 can be right opposite to a target branch blood vessel inlet due to the arc structure of the end section 11, the end section 11 can conveniently and smoothly enter the Marshall vein without a guide wire, marshall intravenous ablation is completed, and the defect that the existing catheter technology cannot be suitable for Marshall intravenous ablation is overcome.

Preferably, the positioning sensor may be a magnetic positioning sensor, an optical fiber positioning sensor or an electronic tag, and the positioning sensor is insulated from the electrodes. The good insulation arrangement can avoid the distortion of the position and the shape display of the catheter in the ablation process.

Preferably, the second electrode 6 is disposed on the outer surface of the first pipe 1, and a temperature sensor is disposed between the second electrode 6 and the first pipe 1. The temperature detection device is used for temperature detection during radio frequency ablation.

In particular, the electrodes and the wires are well insulated from the tube body and other components to avoid energy leakage and dispersion and ensure the safety and effectiveness of the ablation process, especially the high-voltage pulse electric field ablation process.

Example 2

The radiofrequency pulse electric field dual-mode ablation catheter of the embodiment has the same structure as that of the embodiment 1, except that: the positioning sensor is an electronic tag.

The radio-frequency pulse electric field dual-mode ablation catheter of the embodiment realizes positioning by adopting the electronic tag, the electronic tag has more advantages compared with the existing common positioning sensor in terms of size and cost, the electronic tag is applied to the ablation catheter, the ablation catheter with the thinner inner diameter can be more easily placed, and the positioning is more accurate compared with the conventional ablation catheter positioning mode which is optimized by an algorithm or positioned by an electric field.

Specifically, the electronic tag coils with different excitation frequencies have different inductances, the electronic tags with different excitation frequencies can be obtained by adjusting the number of turns of the electronic tag coils, the electronic tags are widely used in the fields of article tracing, anti-counterfeiting, book management and the like, the size of the conventional electronic tag can reach the micron level, and the smallest electronic tag is only 0.0026mm ² Can completely meet the use requirements, and when the catheter is subjected to marking, the direction of the positioning equipment is changedThe electronic tag sends electromagnetic pulse with a certain frequency, the generated electromagnetic field penetrates through the electronic tag antenna, voltage is generated in an antenna coil of the electronic tag and information in the chip is sent to the positioning equipment, the positioning equipment receives signals and then sends the signals to the processor for data processing and analysis, the position of the electronic tag is calculated, and real-time monitoring on the position and the shape of the first pipe body 1 is achieved.

Example 3

The radiofrequency pulse electric field dual-mode ablation catheter of the embodiment has the same structure as that of the embodiment 1, except that: considering that the surface area ratio between the discharge electrodes is related to the energy concentration degree, the larger the surface area ratio between the discharge electrodes is, the more concentrated the electrode energy on the side with smaller surface area is, and the deeper the ablation depth is, the structural definition is performed for all the electrodes arranged on the first tube body 1: the first electrodes 5 discharge independently to perform point ablation, or all the electrodes discharge in a matched mode to form a linear ablation band, or all the electrodes acquire electrophysiological signals.

The radiofrequency pulse electric field dual-mode ablation catheter has the advantages that each electrode can independently collect electrophysiological signals and can also be used for energy transmission, the transmitted energy can be high-voltage pulse energy or radiofrequency energy, the first electrode 5 can independently discharge to perform point ablation, and the multiple electrodes can also discharge to perform linear ablation so as to adapt to different clinical requirements.

Preferably, the ratio of the surface areas of the discharge electrodes is 1-20, and considering the phenomenon that the ionization of blood and tissues around the electrodes may occur due to the over concentration of energy, the ratio of the surface areas of the discharge electrodes is preferably 1-3 in this embodiment.

Specifically, as shown in fig. 2, when the diameters of the distal end section 11 and the proximal end section 12 are the same, all the electrodes are numbered along the distal end to the proximal end of the first tube 1 in sequence by the arabic numerals, the odd-numbered electrodes have the same surface area, the even-numbered electrodes have the same surface area, and the odd-numbered electrodes and the even-numbered electrodes have the same surface area or different surface areas.

Specifically, as shown in fig. 3, when the tube diameters of the distal end section 11 and the proximal end section 12 are different, the electrodes on the distal end section 11 and the proximal end section 12 are numbered sequentially, the electrode surface areas of the odd-numbered positions of the distal end section 11 or the proximal end section 12 are the same, the electrode surface areas of the even-numbered positions are the same, and the electrode surface areas of the odd-numbered positions and the even-numbered positions are the same or different. The electrodes on the distal end section 11 and the electrodes on the proximal end section 12 are relatively independent, so that ablation in the corresponding region can be independently completed.

Specifically, as shown in fig. 4, discharge is performed between the first electrode and the second electrode 61, discharge is performed between the third electrode 62 and the fourth electrode 63, and discharge is performed between the fifth electrode 64 and the sixth electrode 65, so that discharge is performed between adjacent electrodes, a linear ablation zone is formed, a discharge electric field is formed as shown in an outer annular region of the first tube 1 in fig. 4, the first electrode is the first electrode 5, and the rest are the second electrodes 6.

Specifically, as shown in fig. 5, it is a schematic diagram of electric field distribution of the second-position electrode 61 and the third-position electrode 62 discharging to the first-position electrode, so as to realize multi-electrode-to-single-electrode discharging, and since the total surface area of the second-position electrode 61 and the third-position electrode 62 is larger than that of the first-position electrode, energy is concentrated around the first-position electrode.

Specifically, as shown in fig. 6, the first-position electrode and the second-position electrode 61 discharge the third-position electrode 62 and the fourth-position electrode 63, so that multi-electrode discharge to multi-electrode discharge is realized, and compared with electrode discharge shown in fig. 4, the ablation range can be increased, the rigidity of the tube body in the electrode mounting region can be reduced, and the tube body can be bent and manipulated conveniently.

Preferably, the second electrode 6 is a platinum-iridium alloy electrode, a wound electrode or other flexible electrode, the width of the second electrode 6 is 0.5-4.0mm, the distance between adjacent second electrodes 6 is 1-10mm, the distance between adjacent second electrodes 6 is considered to be inversely related to the detection precision and to be positively related to the detection range, and in order to generate a continuous ablation zone in linear ablation application, the distance between adjacent second electrodes 6 is preferably 1-4mm.

Example 4

The radiofrequency pulse electric field dual-mode ablation catheter of the embodiment has the same structure as the embodiment 3, except that: considering the application of the catheter to mapping and ablation in or near the blood vessel, particularly deep in the coronary veins, the electrode size is limited and wire-wound electrodes are employed.

The radiofrequency pulsed electric field bimodal ablation catheter of the embodiment can achieve a larger surface area under the same width compared with a common electrode by adopting the wire-wound electrode.

Specifically, a wire-wound electrode is preferably formed by winding a metal wire on the first tube 1 to reduce the size of each electrode, and meanwhile, the wire-wound electrode has better compliance, and can provide good radial support and bending performance for the first tube 1 to give consideration to the flexibility and compliance of the tube, so that the first tube 1 can be smoothly applied to mapping and ablation in or near a blood vessel.

Specifically, the metal wire can be made of copper, silver, gold, platinum, iridium and other metals or alloys thereof, the diameter is 0.01-0.5mm, the winding pitch is 0-2mm, and the actual adaptability adjustment is carried out according to the principle that the winding density, the surface area of the electrode under the unit width and the electrode rigidity are in positive correlation under the same wire diameter.

Specifically, as shown in fig. 7, the electric field distribution diagram when the wound electrode with the same width discharges to the first electrode 5 is shown, and compared with the electrode pair with the same width as shown in fig. 4, the electric field distribution diagram can be more concentrated around the first electrode 5, and the ablation range is wider.

The above description is only exemplary of the present invention and should not be taken as limiting the scope of the present invention, as any modifications, equivalents, improvements and the like made within the spirit and principles of the present invention are intended to be included within the scope of the present invention.

Claims

1. The utility model provides a radio frequency pulsed electric field bimodal ablation catheter, characterized in that, including first body (1), second body (2) and the control mechanism (3) that set gradually, control mechanism (3) one end and set up connector (4), first body (1) is passed through control mechanism (3) adjustment bending shape, first body (1) tip sets up first electrode (5), a plurality of second electrodes (6) of arranging distribution on first body (1), all electrodes with connector (4) are connected, connector (4) can melt the appearance adaptation with radio frequency respectively and pulsed electric field and be connected.

2. A radiofrequency pulsed electric field bimodal ablation catheter as claimed in claim 1, wherein the first tube (1) comprises a distal section (11) and a proximal section (12), the distal section (11) being 10-30mm in length and the proximal section (12) being 80-150mm in length; the tip section (11) compliance being less than the proximal section (12) compliance; the end section (11) and the proximal section (12) form an included angle alpha, and the alpha is 5-30 degrees.

3. The rf-pulsed-electric-field bimodal ablation catheter according to claim 2, wherein the first tube (1) has an outer diameter of 3F-7F; the distal section (11) outer diameter is smaller than the proximal section (12) outer diameter.

4. A rf pulsed electric field bimodal ablation catheter as claimed in claim 3, wherein said tip section (11) is curved, and a tangent to the curve of said tip section (11) forms said angle α with said proximal section (12); a traction structure is arranged in the proximal section (12), and the control mechanism (3) controls the bending shape of the first pipe body (1) through the traction structure.

5. The rf-pulsed electric field bimodal ablation catheter as claimed in claim 4, wherein the electrodes on said tip section (11) and said proximal section (12) are sequentially numbered, respectively, the odd numbered electrodes of said tip section (11) or said proximal section (12) having the same surface area, the even numbered electrodes having the same surface area, and the odd and even numbered electrodes having the same or different surface areas.

6. The rf-pulsed electric field bimodal ablation catheter as claimed in claim 5, wherein all electrodes on the first catheter are sequentially numbered when the distal segment (11) and the proximal segment (12) are the same diameter.

7. The rf-pulsed electric field bimodal ablation catheter as claimed in claim 1, wherein the first electrodes (5) are individually discharged for point ablation, or all electrodes cooperate to discharge to form a linear ablation zone, or all electrodes are used for electrophysiological signal acquisition.

8. The rf-pulsed electric field bimodal ablation catheter of claim 7, wherein during linear ablation, electrical discharge is provided between adjacent electrodes, or multiple electrodes are provided for a single electrode, or multiple electrodes are provided for multiple electrodes; the ratio of the surface areas of the discharge electrodes is 1-20.

9. The rf-pulsed electric field bimodal ablation catheter as claimed in claim 1, wherein said second electrode (6) is a pt-ir alloy electrode, a wire-wound electrode or other flexible electrode, said second electrode (6) has a width of 0.5-4.0mm, said second electrodes (6) are spaced from each other by 1-10mm, and the spacing between said second electrodes (6) is inversely related to the detection accuracy and is positively related to the detection range.

10. The rf-pulsed electric field bimodal ablation catheter according to claim 9, wherein the second electrode (6) is a wire-wound electrode, and is made by winding a metal wire around the first tube (1), wherein the metal wire has a diameter of 0.01-0.5mm, a winding pitch of 0-2mm, and the winding density, the electrode surface area per unit width, and the electrode rigidity are positively correlated with each other at the same wire diameter.

11. A rf pulsed electric field bimodal ablation catheter according to claim 1, characterized in that temperature sensors are provided between all electrodes and the first catheter body (1).

12. A rf pulsed electric field bimodal ablation catheter as claimed in claim 2, characterized in that said first catheter body (1) is provided with at least a distal positioning sensor (7) and a proximal positioning sensor (9), said distal positioning sensor (7) being arranged between said first electrode (5) and said first catheter body (1), said proximal positioning sensor (9) being arranged between said first catheter body (1) and said second catheter body (2).

13. A rf-pulsed-electric-field bimodal ablation catheter as claimed in claim 12, wherein an intermediate location sensor (8) is provided between the tip section (11) and the proximal section (12).

14. The rf-pulsed electric field bimodal ablation catheter of claim 13, wherein the localization sensor is a magnetic localization sensor, a fiber optic localization sensor, or an electronic tag, the localization sensor being isolated from the electrodes.