CN118830912B - Flexible pulse electric field ablation catheter and working method thereof - Google Patents

Abstract

The present invention belongs to the technical field of medical equipment, and specifically relates to a flexible pulse electric field ablation catheter, which includes a multi-lumen catheter, wherein an air circuit hose and an electrode wire are installed inside the multi-lumen catheter, an endoscope is fixed to one end of the multi-lumen catheter, an air hole is opened at one end of the outer side of the multi-lumen catheter close to the endoscope, and the output end of the air circuit hose is connected to the air hole. The present invention uses an air pump module to make the electrode carrier and the flexible electrode stretch synchronously, so that the flexible electrode can fit the target tissue, and the two ends of the electrode carrier in the stretched state are supported and limited by the cooperation of multiple inner support cross arms and outer support cross arms, so that the electrode carrier in the stretched state forms a structure similar to a cylinder. Compared with the method in which the electrode is parallel or perpendicular to the axis of the catheter, the spiral arrangement of the electrodes can achieve a more uniform distribution of the pulsed electric field.

Description

Flexible pulse electric field ablation catheter and working method thereof

Technical Field

The invention belongs to the technical field of medical equipment, and particularly relates to a flexible pulse electric field ablation catheter and a working method thereof.

Background

Diabetes is a common and highly developed condition that affects lives of hundreds of millions of people worldwide. Traditional therapeutic approaches include diet control, exercise enhancement, oral hypoglycemic agents, insulin injections, and the like. However, these conventional methods reduce the quality of life of the patient to some extent, which causes inconvenience to the patient. For example, oral hypoglycemic agents may cause hypoglycemia, dyspepsia, weight gain, or other discomfort, and chronic administration may also lead to resistance of some patients to the agent.

Currently, methods for treating chronic diseases such as obesity and diabetes by duodenal intima reconstruction have been proposed. However, if conventional treatment of the duodenum is performed by electrothermal ablation, there is a risk of overheating, the ablation boundary cannot be accurately controlled, more layers of the duodenum (e.g., the myometrium) may be damaged than expected, and unpredictable risks are presented to the patient for recovery after treatment. Traditional solutions require long-term patient compliance, but the final therapeutic effect is often not satisfactory.

In view of the above problems, the present disclosure proposes a flexible pulsed electric field ablation catheter and a working method thereof to improve the summary of the problems.

The invention aims to provide a flexible pulse electric field ablation catheter, which enables an electrode carrier and a flexible electrode to synchronously extend through an air pump module, enables the flexible electrode to be attached to target tissues, forms support and limit on two ends of the electrode carrier in an extending state through matching of a plurality of inner support cross arms and outer support cross arms, enables the electrode carrier in the extending state to form a cylinder-like structure, and achieves more uniform distribution of a pulse electric field through electrode spiral arrangement compared with a mode that electrodes are parallel or perpendicular to the axis of the catheter.

The technical scheme adopted by the invention is as follows:

the utility model provides a flexible pulsed electric field ablation pipe, includes the multicavity pipe, the inside of multicavity pipe is equipped with gas circuit hose and electrode wire, the one end of multicavity pipe is fixed with the scope, the one end that is close to the scope in the multicavity pipe outside has seted up the gas pocket, just the output of gas circuit hose is connected with the gas pocket, still includes:

The electrode carrier is arranged at one end, close to the endoscope, of the outer side of the multi-cavity catheter, and is matched with the air hole;

the flexible electrodes are spirally distributed on the outer side of the electrode carrier and are connected with the electrode wires;

The first supporting mechanisms are assembled at one end, close to the endoscope, of the outer side of the multi-cavity catheter;

The second supporting mechanisms are assembled on the outer side of the multi-cavity catheter and are positioned on the outer side of the first supporting mechanism, and the second supporting mechanisms are in one-to-one correspondence with the first supporting mechanisms;

The handle assembly is arranged at one end of the multi-cavity catheter far away from the endoscope, and the handle assembly is connected with the first supporting mechanism and the handle assembly is connected with the second supporting mechanism, and the handle assembly can respectively drive the first supporting mechanism and the second supporting mechanism to operate;

And in the initial state, the electrode carrier and the flexible electrode are in a compressed state, and after a gas medium is input into the electrode carrier through the gas path hose, the electrode carrier drives the flexible electrode to extend until the flexible electrode is attached to target tissues.

In a preferred embodiment, the electrode carrier is made of any one of PI, PET, PEEK, PTFE.

In a preferred embodiment, the flexible electrode is made of any one of gold, silver and titanium.

In a preferred embodiment, the electrode carrier has a material thickness ranging from 10 μm to 60 μm.

In a preferred scheme, a plurality of limiting bosses are fixed at the outer side of the multi-cavity catheter and positioned at the two ends of the air holes, and the limiting bosses are in one-to-one correspondence with the first supporting mechanisms.

In a preferred scheme, the first supporting mechanism comprises a guide plate and a plurality of internal supporting cross arms, wherein the guide plate is slidably connected to the outer side of the multi-cavity catheter, the internal supporting cross arms are all rotatably connected to the outer side of the guide plate, the handle assembly and the internal supporting cross arms are all connected with each other, and in an initial state, the internal supporting cross arms are mutually attached to form a first tubular structure.

In a preferred scheme, the second supporting mechanism comprises a supporting tube and a plurality of external supporting cross arms, wherein the supporting tube is fixed on the outer side of the multi-cavity catheter and is positioned on the outer side of the first supporting mechanism, the supporting tube is fixedly connected with the electrode carrier, the external supporting cross arms are all rotationally connected to one end, close to the air hole, of the supporting tube, the external supporting cross arms are connected with the handle assembly, and in an initial state, the external supporting cross arms are mutually attached to form a second tubular structure.

In a preferred scheme, one end of the inner supporting cross arm and one end of the outer supporting cross arm, which are far away from the air hole, are respectively provided with a rotating boss, and one side of the rotating boss, which is close to the multi-cavity catheter, is provided with a right-angle limiting surface.

A method of operating a flexible pulsed electric field ablation catheter, suitable for use with any one of the above-described flexible pulsed electric field ablation catheters, comprising the steps of:

determining pulse parameters, wherein the pulse parameters comprise pulse power and pulse frequency;

The limit of the second supporting mechanism is relieved through the handle assembly, and the first supporting mechanism is driven to operate through the handle assembly, so that the first supporting mechanism is converted into an extending state from an initial state, the second supporting mechanism is driven to be converted into the extending state from the initial state through the first supporting mechanism, and the electrode carrier in the extending state is supported and limited through the cooperation of the first supporting mechanism and the second supporting mechanism;

Inputting a gas medium into the electrode carrier through the gas pump module, so that the electrode carrier and the flexible electrode are synchronously stretched;

The pulse generating module is started, and the flexible electrode releases the ablation electric field.

The invention has the technical effects that:

According to the invention, a gas medium is input into the electrode carrier through the gas pump module, so that the electrode carrier and the flexible electrode are synchronously stretched, the flexible electrode can be attached to target tissues, meanwhile, the handle assembly drives the first supporting mechanism and the second supporting mechanism to operate, the two ends of the electrode carrier in a stretched state are supported and limited through the cooperation of the inner supporting cross arms and the outer supporting cross arms, the pulse generation module is started to perform pulse ablation on the target tissues through the flexible electrode, and compared with a mode that the electrodes are parallel or perpendicular to the axis of the catheter, the pulse electric field is more uniformly distributed through the spiral arrangement of the electrodes;

According to the invention, the two ends of the electrode carrier in an extending state are supported and limited by the cooperation of the inner supporting cross arms and the outer supporting cross arms, so that the electrode carrier in the extending state forms a structure similar to a cylinder, and the target tissue is subjected to pulse ablation through the flexible electrode, so that the boundary accurate ablation can be realized, and the electrode carrier can be applied to duodenal lining reconstruction to treat obesity, diabetes and other chronic diseases.

Drawings

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

FIG. 2 is a schematic view of a portion of the structure of the present invention;

FIG. 3 is a partial cross-sectional view of the present invention;

FIG. 4 is an enlarged partial schematic view of the present invention at A in FIG. 3;

FIG. 5 is a schematic view of the partial construction of the internal support cross arm of the present invention;

FIG. 6 is a partial cross-sectional view of the internal support cross-arm of the present invention;

FIG. 7 is a schematic view of the structure of the invention in an extended state;

FIG. 8 is a cross-sectional view of the structure of the present invention in an extended state;

FIG. 9 is a graph of the distribution of pulsed electric fields in the XOY direction in a simulation analysis in accordance with the present invention;

FIG. 10 is a graph of the distribution of pulsed electric fields in the XOZ direction in a simulation analysis in accordance with the present invention;

FIG. 11 is a graph of the pulse electric field profile in the YOZ direction in a simulation analysis of the present invention.

In the drawings, the list of components represented by the various numbers is as follows:

10. The endoscope comprises a multi-cavity catheter, 11, an endoscope, 12, an air hole, 13, an electrode carrier, 14, a flexible electrode, 15, a limiting boss, 20, a first supporting mechanism, 21, a guide plate, 22, an inner supporting cross arm, 30, a second supporting mechanism, 31, a supporting tube, 32, an outer supporting cross arm, 40 and a handle assembly.

Detailed Description

In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways other than those described herein, and persons skilled in the art will readily appreciate that the present invention is not limited to the specific embodiments disclosed below.

Further, reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic can be included in at least one implementation of the invention. The appearances of the phrase "in one preferred embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments.

In describing the embodiments of the present invention in detail, the cross-sectional view of the device structure is not partially enlarged to a general scale, and the schematic drawings are only examples, which should not limit the scope of the present invention. In addition, the three-dimensional dimensions of length, width and depth should be included in actual fabrication.

Referring to fig. 1 to 4, a first embodiment of the present invention provides a flexible pulse electric field ablation catheter, which includes a multi-cavity catheter 10, an air path hose and an electrode wire are assembled in the multi-cavity catheter 10, an endoscope 11 is fixed at one end of the multi-cavity catheter 10, an air hole 12 is formed at one end, close to the endoscope 11, of the outer side of the multi-cavity catheter 10, and an output end of the air path hose is connected with the air hole 12, and further includes:

The electrode carrier 13 is arranged at one end, close to the endoscope 11, of the outer side of the multi-cavity catheter 10, and the electrode carrier 13 is matched with the air hole 12;

the flexible electrodes 14 are spirally distributed on the outer side of the electrode carrier 13, and the flexible electrodes 14 are connected with electrode wires;

The first support mechanisms 20 are assembled at one end, close to the endoscope 11, of the outer side of the multi-cavity catheter 10, and the first support mechanisms 20 are respectively positioned at two ends of the electrode carrier 13;

The plurality of second supporting mechanisms 30 are assembled on the outer side of the multi-cavity catheter 10 and are positioned on the outer side of the first supporting mechanism 20, the plurality of second supporting mechanisms 30 are respectively positioned at two ends of the electrode carrier 13, and the plurality of second supporting mechanisms 30 are in one-to-one correspondence with the plurality of first supporting mechanisms 20;

The handle assembly 40, the handle assembly 40 is disposed at one end of the multi-cavity catheter 10 far away from the endoscope 11, and the handle assembly 40 is connected with the air path hose, the handle assembly 40 and the electrode lead, the handle assembly 40 and the first support mechanism 20, and the handle assembly 40 and the second support mechanism 30, and the handle assembly 40 can drive the first support mechanism 20 and the second support mechanism 30 to operate respectively;

In the initial state, the electrode carrier 13 and the flexible electrode 14 are both located inside the second supporting mechanism 30 and are in a compressed state, after a gas medium is input into the electrode carrier 13 through the gas path hose, the electrode carrier 13 drives the flexible electrode 14 to stretch until the flexible electrode 14 is attached to the target tissue, and the electrode carrier 13 in the stretched state can be supported through the cooperation of the plurality of first supporting mechanisms 20 and the second supporting mechanisms 30.

Here, the number of the flexible electrodes 14 is at least two.

It should be noted that, the handle assembly 40 is provided with a plurality of adjusting units, and the adjusting units are connected with the first supporting mechanism 20 and the adjusting units are connected with the second supporting mechanism 30 through the binding wires, and in an initial state, the plurality of adjusting units can respectively limit the first supporting mechanism 20 and the second supporting mechanism 30 through the binding wires, so that the first supporting mechanism 20 and the second supporting mechanism 30 are prevented from running when ablation is not performed.

Further, the pulse ablation control system is used in combination with the device, and at least comprises a power supply module, a pulse generation module, an impedance detection module, a control module and an air pump module, wherein the power supply module is electrically connected with the control module, the power supply module is electrically connected with the pulse generation module, the pulse generation module is electrically connected with the impedance monitoring module, the pulse generation module is electrically connected with the flexible electrode 14, the air pump module is connected with the air channel hose, the power supply module is used for supplying electric energy, the pulse generation module is used for sending pulse signals to the flexible electrode 14, the impedance detection module is used for detecting impedance values among a plurality of pulse electrodes of the electrodes, further determining the impedance value of target tissue, the control module can receive the impedance value of focus tissue detected by the impedance detection module, and determine ablation parameters (such as ablation time, pulse voltage, pulse width, pulse frequency and the like) according to the impedance value of focus tissue, and the air pump module can convey or extract gas media into the electrode carrier 13.

In this embodiment, an image of a target tissue is acquired by an imaging device, one end of the multi-lumen catheter 10 far from the handle assembly 40 is conveyed to the target tissue, an impedance value of the ablated tissue is acquired by a pulse ablation control system, pulse parameters are determined, the handle assembly 40 is operated, the limit on the second support mechanism 30 is released by the handle assembly 40, then the handle assembly 40 drives the plurality of first support mechanisms 20 to move towards the direction close to the air hole 12, meanwhile, the first support mechanisms 20 are converted from an initial state to an extended state, the first support mechanisms 20 drive the second support mechanisms 30 to synchronously operate during the extension process, so that the second support mechanisms 30 are also converted from the initial state to an extended state, support and limit are formed by the cooperation of the first support mechanisms 20 and the second support mechanisms 30 in the extended state to the electrode carrier 13 (in this process, the electrode carrier 13 can be partially stretched but cannot be fully stretched under the drive of the first supporting mechanism 20), the air pump module is started, a gas medium is input into the electrode carrier 13 through the air path hose, the electrode carrier 13 is gradually stretched, the initial state is changed into the stretched state, meanwhile, the electrode carrier 13 drives the flexible electrode 14 to stretch until the flexible electrode 14 is tightly attached to target tissues, the pulse generating module is started to send pulse signals to the flexible electrode 14, the target tissues are subjected to pulse ablation through the flexible electrode 14, the spiral flexible electrode 14 realizes more uniform distribution of a pulse electric field in a mode of being parallel or perpendicular to the axis of the catheter compared with the electrode, meanwhile, the ablation boundary is controllable, the boundary precise ablation is realized, the method can be applied to the reconstruction of the duodenal internal membrane to treat obesity, diabetes and other chronic diseases after the ablation is finished, the handle assembly 40 drives the first supporting mechanism 20 to reversely run, the support of the first supporting mechanism 20 to the electrode carrier 13 is released, the first supporting mechanism 20 is converted from an unfolding state to an initial state, the air inside the electrode carrier 13 is extracted through the air pump module, the electrode carrier 13 and the flexible electrode 14 are contracted, the handle assembly 40 drives the two second supporting mechanisms 30 to reversely run, the unfolding state is converted to the initial state, the handle assembly 40 limits the second supporting mechanisms 30, and the device can be extracted from a patient after ablation is completed.

In a specific embodiment, referring to fig. 9 to 11, a simulation analysis is performed to show pulse electric field distribution by taking unidirectional voltage as an example, the applied pulse voltage is 2000V, the pulse frequency is 1Hz, the pulse width is 100us, the pulse electric field distribution is uniform, the ablation boundary is controllable, and the boundary accurate ablation can be realized.

In a preferred embodiment, the electrode carrier 13 is made of any one of PI, PET, PEEK, PTFE or other medical polymer materials, the thickness of the electrode carrier 13 ranges from 10 μm to 60 μm, the flexible electrode 14 is made of any one of gold, silver, titanium or other conductive polymer materials, specifically, in this embodiment, the electrode carrier 13 is preferably made of PEEK, the thickness of the electrode carrier 13 is preferably 20 μm, and the flexible electrode 14 is preferably made of titanium.

In this embodiment, the medical polymer materials generally have good biocompatibility, which means that they have good compatibility with human tissues and organisms, and such materials can be combined with human tissues without adverse effects such as rejection, allergy, corrosion, and carcinogenesis.

Referring to fig. 3 to 4 again, a plurality of limiting bosses 15 are fixed on the outer side of the multi-cavity catheter 10 and located at two ends of the air hole 12, and the plurality of limiting bosses 15 and the plurality of first supporting mechanisms 20 are in one-to-one correspondence.

In this embodiment, when the handle assembly 40 drives the first support mechanism 20 to move in the direction approaching each other, the positioning boss 15 can limit the travel of the first support mechanism 20, so that the excessive moving distance of the first support mechanism 20 is avoided, and effective support and positioning of the electrode carrier 13 cannot be achieved.

Referring to fig. 3 to 4 again, the first supporting mechanism 20 includes a guide plate 21 and a plurality of inner supporting cross arms 22, the guide plate 21 is slidably connected to the outer side of the multi-cavity catheter 10, the plurality of inner supporting cross arms 22 are rotatably connected to the outer side of the guide plate 21, and the guide plate 21, the handle assembly 40, and the inner supporting cross arms 22 and the handle assembly 40 are all connected to each other, wherein in an initial state, the plurality of inner supporting cross arms 22 are mutually attached to form a first tubular structure.

In the present embodiment, the number of the first supporting mechanisms 20 and the second supporting mechanisms 30 is two.

In this embodiment, when the pulse ablation is required to be performed on the target tissue, the handle assembly 40 is used to release the limit on the second supporting mechanism 30, the handle assembly 40 is used to drive the guide plates 21 in the two first supporting mechanisms 20 to move towards each other, after the guide plates 21 are contacted with the limit boss 15, the limit boss 15 limits the guide plates 21, the handle assembly 40 is used to drive all the inner supporting cross arms 22 in the two first supporting mechanisms 20 to rotate, the inner supporting cross arms 22 will drive the electrode carrier 13 to partially stretch during rotation, after the inner supporting cross arms 22 are contacted with the second supporting mechanisms 30, the inner supporting cross arms 22 will drive the second supporting mechanisms 30 to operate, so that the second supporting mechanisms 30 are changed from the initial state to the stretched state (at this time, the electrode carrier 13 is partially clamped between the inner supporting cross arms 22 and the second supporting mechanisms 30), the electrode carrier 13 is supported and limited by the cooperation of the inner supporting cross arm 22 and the second supporting mechanism 30, a gas medium is input into the electrode carrier 13 through the air pump module, so that the electrode carrier 13 and the flexible electrode 14 are synchronously stretched until the flexible electrode 14 is tightly attached to target tissues, after the pulse generating module is started, pulse ablation is carried out on the target tissues through the flexible electrode 14, the spiral flexible electrode 14 is more uniformly distributed in a pulse electric field mode in parallel or perpendicular to the axis of the catheter compared with the mode of the electrode, meanwhile, the ablation boundary is controllable, the boundary is accurately ablated, after the ablation is finished, the inner supporting cross arm 22 is driven to reset through the handle assembly 40, the guide plates 21 in the two first supporting mechanisms 20 are moved in the directions away from each other, the support on the inner parts of the electrode carrier 13 is released, the air pump module and the second supporting mechanism 30 are reversely operated, the electrode carrier 13, the flexible electrode 14 and the second supporting mechanism 30 are changed from an extended state to an initial state, and the handle assembly 40 drives the drawing wire to move and limit the second supporting mechanism 30 in the initial state.

Referring to fig. 3 to 4 again, the second supporting mechanism 30 includes a supporting tube 31 and a plurality of external supporting cross arms 32, the supporting tube 31 is fixed on the outer side of the multi-cavity catheter 10 and is located on the outer side of the first supporting mechanism 20, two ends of the supporting tube 31 and the electrode carrier 13 in the two second supporting mechanisms 30 are respectively and fixedly connected, the plurality of external supporting cross arms 32 are respectively and rotatably connected to one end of the supporting tube 31, which is close to the air hole 12, and the external supporting cross arms 32 are connected with the adjusting unit, wherein in an initial state, the plurality of external supporting cross arms 32 are mutually attached to form a second tubular structure.

It should be noted that, the support tube 31 and the electrode carrier 13 in the plurality of second support mechanisms 30 form a closed space, so that the gas medium is prevented from overflowing when the gas medium is input into the electrode carrier 13 through the gas pump module.

It should be noted that, the guide plates 21 and the adjusting and controlling units, the inner supporting cross arm 22 and the adjusting and controlling units, and the outer supporting cross arm 32 and the adjusting and controlling units are all connected by the binding wires, specifically, when the adjusting and controlling units adapted to the guide plates 21 are operated in the forward direction, the guide plates 21 in the two first supporting mechanisms 20 move in the directions approaching to each other; when the regulating and controlling units matched with the guide plates 21 are operated reversely, the guide plates 21 in the two first supporting mechanisms 20 move in the directions away from each other; when the regulating units matched with the inner supporting cross arms 22 are operated forward, the inner supporting cross arms 22 are rotated forward, the first supporting mechanism 20 is changed from an initial state to an extended state, when the regulating units matched with the inner supporting cross arms 22 are operated backward, the inner supporting cross arms 22 are rotated backward, the first supporting mechanism 20 is changed from an extended state to an initial state, when the regulating units matched with the outer supporting cross arms 32 are operated forward, the regulating units release the limit of the outer supporting cross arms 32, the outer supporting cross arms 32 can be rotated and drive the connected wire-drawing wires to synchronously move, at the moment, the second supporting mechanism 30 can be changed from the initial state to the extended state, when the regulating units matched with the outer supporting cross arms 32 are rotated backward, the outer supporting cross arms 32 can be driven to reversely operate to reset through the wire-drawing wires, after the outer supporting cross arms 32 are rotated to the reset state, the wire-drawing wires are in the tight state, the limit of the outer supporting cross arms 32 can be formed through the wire-drawing wires in the tight state, meanwhile, the second supporting mechanism 30 is changed from the extended state to the initial state, the handle assembly 40 can be changed into the extended state, the handle assembly 40 can be adjusted to the mature environment according to the specific application requirements, and will not be further described.

Here, the forward operation and the reverse operation represent only the state of the structural member operation, and are not particularly limited as the operation direction.

In this embodiment, an image of a target tissue is acquired through an imaging device, one end of the multi-cavity catheter 10 far away from the handle assembly 40 is conveyed to the target tissue, the limit of the outer support cross arm 32 is released through the handle assembly 40, the first support mechanism 20 is driven by the handle assembly 40 to be converted into an extended state from an initial state, wherein after the rotating inner support cross arm 22 and the outer support cross arm 32 are contacted, the outer support cross arm 32 can be driven to synchronously rotate, the second support mechanism 30 is driven by the inner support cross arm 22 to be converted into an extended state from the initial state, the electrode carrier 13 is supported and limited through the cooperation of the inner support cross arms 22 and the outer support cross arms 32, an air pump module is started to input a gaseous medium into the electrode carrier 13, the electrode carrier 13 and the flexible electrode 14 are enabled to synchronously extend, the electrode carrier 13 in the extended state forms a cylinder-like structure, the flexible electrode 14 and the target tissue are tightly attached, the first support cross arm 20 is driven by a regulating and controlling unit matched with the first support mechanism 20 to be converted into the initial state after the target tissue is ablated through the flexible electrode 14, and simultaneously, the air pump is started to drive the air pump is driven by the air pump mechanism 20 to be converted into the air pump from the initial state through the regulating and controlling unit matched with the first support cross arm 20, the air pump and the external support cross arm 32 through the reverse direction regulating and controlling module, and the air carrier 13 is enabled to form a telescopic state, and the initial state is enabled to be matched with the external carrier 32 through the external support cross arm and a regulating and a telescopic carrier through the external carrier 32.

Referring to fig. 5 to 6 again, the ends of the inner support cross arm 22 and the outer support cross arm 32 far away from the air hole 12 are respectively provided with a rotation boss, the inside of the rotation boss is provided with a shaft lever, the guide plate 21 and the inner support cross arm 22 as well as the support tube 31 and the outer support cross arm 32 are respectively connected through rotation bosses in a rotation way, and one side of the rotation boss, which is close to the multi-cavity catheter 10, is provided with a right-angle limiting surface.

Further, in the present embodiment, the angular rotation range of the inner support cross arm 22 and the outer support cross arm 32 is 0 to 90 °.

In this embodiment, the right-angle limiting surface is provided to limit the rotation angle of the guide plate 21 and the support pipe 31 when the guide plate 21 and the support pipe 31 are rotated and reset, so that the guide plate 21 and the support pipe 31 are prevented from being rotated continuously after being reset.

A method of operating a flexible pulsed electric field ablation catheter, suitable for use in any one of the above, comprising the steps of:

acquiring an image of the target tissue by the imaging device, and delivering the end of the multi-lumen catheter 10 remote from the handle assembly 40 to the target tissue;

Determining pulse parameters, wherein the pulse parameters comprise pulse power and pulse frequency;

the limit of the outer supporting cross arm 32 is relieved through the handle assembly 40, the two guide plates 21 are driven to move towards the directions approaching to each other through the handle assembly 40, the inner supporting cross arm 22 is driven to rotate, the outer supporting cross arm 32 is driven to rotate through the plurality of inner supporting cross arms 22, and the two ends of the electrode carrier 13 in the stretching state are supported and limited through the cooperation of the inner supporting cross arm 22 and the outer supporting cross arm 32 in the stretching state;

Starting an air pump module, and inputting a gas medium into the electrode carrier 13 through an air path hose, so that the electrode carrier 13 and the flexible electrode 14 are synchronously stretched until the flexible electrode 14 is attached to target tissues;

The pulse generation module is activated and the flexible electrode 14 releases the ablating electric field to ablate the target tissue.

The working principle of the invention is as follows:

Referring to fig. 7 to 8, an image of a target tissue is acquired by an imaging device, one end of the multi-lumen catheter 10 close to the endoscope 11 is conveyed to the target tissue, an impedance value of the ablated tissue is acquired by a pulse ablation control system, pulse parameters are determined, the handle assembly 40 is operated, the limit of the external support cross arm 32 is released by the handle assembly 40, the first support mechanism 20 is driven by the handle assembly 40 to be converted from an initial state to an extended state, in the process, the external support cross arm 32 is driven by the internal support cross arm 22 to rotate, the second support mechanism 30 is converted from the initial state to the extended state, the internal support cross arm 22 and the external support cross arm 32 in the extended state cooperate to form support and limit on both ends of the electrode carrier 13 in the extended state, the air pump module is started to input a gaseous medium into the electrode carrier 13, so that the electrode carrier 13 and the flexible electrode 14 are synchronously extended, the electrode carrier 13 is made to form a cylinder-like structure until the flexible electrode 14 is attached to the target tissue, the pulse generating module is started to send pulse signals to the flexible electrode 14, the target tissue is subjected to pulse ablation through the flexible electrode 14, after ablation is finished, the first supporting mechanism 20 is driven by a regulating and controlling unit matched with the first supporting mechanism 20 to be converted into an initial state from an extended state, meanwhile, the air pump module is started to reversely operate, the air medium in the electrode carrier 13 is extracted through the air pump module, the electrode carrier 13 in the extended state and the flexible electrode 14 are contracted, the outer supporting cross arm 32 is driven to reversely rotate through a regulating and controlling unit matched with the outer supporting cross arm 32, the second supporting mechanism 30 is converted into the initial state from the extended state, the outer supporting cross arm 32 is formed to limit again through the cooperation of the regulating and controlling unit and a bundling wire, the device is withdrawn from the patient when the electrode carrier 13, the flexible electrode 14, the first support mechanism 20 and the second support mechanism 30 are all in an initial state.

The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention. Structures, devices and methods of operation not specifically described and illustrated herein, unless otherwise indicated and limited, are implemented according to conventional means in the art.

Claims (9)

1. The utility model provides a flexible pulsed electric field ablation catheter, its characterized in that includes multicavity pipe (10), the inside of multicavity pipe (10) is equipped with gas circuit hose and electrode wire, the one end of multicavity pipe (10) is fixed with scope (11), gas pocket (12) have been seted up to the one end that is close to scope (11) in multicavity pipe (10) outside, just the output of gas circuit hose and gas pocket (12) are connected, still include:

The electrode carrier (13) is arranged at one end, close to the endoscope (11), of the outer side of the multi-cavity catheter (10), and the electrode carrier (13) is matched with the air hole (12);

The flexible electrodes (14) are spirally distributed on the outer side of the electrode carrier (13), and the flexible electrodes (14) are connected with electrode wires;

A plurality of first supporting mechanisms (20), wherein the first supporting mechanisms (20) are all assembled at one end, close to the endoscope (11), of the outer side of the multi-cavity catheter (10);

The second supporting mechanisms (30) are assembled on the outer side of the multi-cavity catheter (10), and the second supporting mechanisms (30) are positioned on the outer side of the first supporting mechanism (20) and correspond to the first supporting mechanisms (20) one by one;

The handle assembly (40) is arranged at one end, far away from the endoscope (11), of the multi-cavity catheter (10), the handle assembly (40) and the first supporting mechanism (20) are connected with each other, the handle assembly (40) can drive the first supporting mechanism (20) and the second supporting mechanism (30) to operate respectively, the limit on the second supporting mechanism (30) is released through the handle assembly (40), then the first supporting mechanism (20) is driven to operate through the handle assembly (40), so that the first supporting mechanism (20) is converted into an extending state from an initial state, the second supporting mechanism (30) is driven to be converted into the extending state from the initial state through the first supporting mechanism (20), and the electrode carrier (13) in the extending state is supported and limited through the cooperation of the first supporting mechanism (20) and the second supporting mechanism (30);

in the initial state, the electrode carrier (13) and the flexible electrode (14) are in a compressed state, and after a gas medium is input into the electrode carrier (13) through the air pump module, the electrode carrier (13) drives the flexible electrode (14) to synchronously extend until the flexible electrode (14) is attached to target tissues.

2. A flexible pulsed electric field ablation catheter in accordance with claim 1, wherein the electrode carrier (13) is any one of PI, PET, PEEK, PTFE.

3. A flexible pulsed electric field ablation catheter in accordance with claim 1, wherein said flexible electrode (14) is made of any one of gold, silver, and titanium.

4. A flexible pulsed electric field ablation catheter as claimed in claim 1, wherein the electrode carrier (13) has a material thickness in the range of 10-60 μm.

5. The flexible pulsed electric field ablation catheter of claim 1, wherein a plurality of limiting bosses (15) are fixed at two ends of the plurality of air holes (12) and outside the multi-cavity catheter (10), and the plurality of limiting bosses (15) are in one-to-one correspondence with the plurality of first supporting mechanisms (20).

6. A flexible pulsed electric field ablation catheter according to claim 1, wherein said first support means (20) comprises a guide plate (21) and a plurality of inner support cross arms (22), said guide plate (21) being slidably connected to the outer side of the multi-lumen catheter (10), a plurality of said inner support cross arms (22) being rotatably connected to the outer side of the guide plate (21), and said guide plate (21) and handle assembly (40) being interconnected with each other and said inner support cross arms (22) and handle assembly (40), and in an initial state, a plurality of said inner support cross arms (22) being in contact with each other to form a first tubular structure.

7. A flexible pulsed electric field ablation catheter according to claim 6, wherein the second support mechanism (30) comprises a support tube (31) and a plurality of external support cross arms (32), the support tube (31) is fixed on the outer side of the multi-cavity catheter (10) and is located on the outer side of the first support mechanism (20), the support tube (31) is fixedly connected with the electrode carrier (13), the plurality of external support cross arms (32) are all rotatably connected to one end, close to the air hole (12), of the support tube (31), the external support cross arms (32) are connected with the handle assembly (40), and in an initial state, the plurality of external support cross arms (32) are mutually attached to form a second tubular structure.

8. The flexible pulsed electric field ablation catheter of claim 7, wherein the ends of the inner support cross arm (22) and the outer support cross arm (32) away from the air hole (12) are respectively provided with a rotating boss, and a right-angle limiting surface is arranged on one side of the rotating boss, which is close to the multi-cavity catheter (10).

9. A method of operating a flexible pulsed electric field ablation catheter, adapted for use with a flexible pulsed electric field ablation catheter as defined in any one of claims 1-8, comprising the steps of:

determining pulse parameters, wherein the pulse parameters comprise pulse power and pulse frequency;

the pulse generating module is activated and the flexible electrode (14) releases the ablative electric field.