CN120227138A - Pulse ablation system and control method of pulse ablation system - Google Patents

Abstract

The invention relates to the field of cardiac ablation, and provides a pulse ablation system and a control method of the system, wherein the pulse ablation system comprises a pulse ablation clamp and a pulse ablation instrument, the pulse ablation clamp comprises a clamp body and a jaw part formed by a fixed clamp arm and a movable clamp arm, the clamp body comprises a chute, n first electrodes are arranged on the movable clamp arm from a far end to a near end along the extending direction of the jaw part, n+1 second electrodes are arranged on the fixed clamp arm, and n is more than or equal to 2; in the direction perpendicular to the extension direction of the fixed clamp arm, the projection of each first electrode on the fixed clamp arm is positioned between two second electrodes, all the first electrodes are arranged outside the sliding groove, and at least one part of the (n+1) th second electrode is arranged inside the sliding groove. The pulse ablation instrument comprises a pulse generation module, a central control module and an interaction control module. At least one of the pulse ablation clamp and the pulse ablation instrument includes an impedance detection module. The ablation system and the control method avoid the condition of missed ablation, and can not generate electric arcs, thereby improving the ablation effect.

Description

Pulse ablation system and control method thereof

Technical Field

The invention relates to the field of cardiac ablation, in particular to a pulse ablation system and a control method of the pulse ablation system.

Background

Atrial fibrillation is one of the most common arrhythmic conditions, the symptoms of which appear as irregular heart beats. The incidence of atrial fibrillation in the general population is 0.5% to 1.5%. Worldwide, the patients with atrial fibrillation reach 3,350 ten thousand people, and about 800 ten thousand patients with atrial fibrillation exist in China. The risk of stroke is very high for patients with atrial fibrillation, and in China, the stroke is an important cause of death, and the stroke caused by atrial fibrillation is usually more serious in clinical manifestation, higher in death rate and easier to relapse. Thus, treatment of atrial fibrillation is not sustained.

For the treatment of atrial fibrillation, the common mode is intracardiac interventional catheter treatment, and the method is small in wound, quick in recovery and high in safety. However, for some patients with serious symptoms, surgical invasive treatment is required, and under the condition of surgical chest opening, the commonly used devices are an ablation forceps and an ablation pen, and meanwhile, the requirements on the treatment effect and the treatment time are met, so that the time required for treatment is reduced as much as possible, and the treatment effect is ensured.

Most of the existing ablation forceps are radio frequency ablation forceps, but the ablation is carried out by using radio frequency energy, the ablation damage range is not easy to control, the current latest mode is to carry out ablation by using pulse energy, and an ablation line is accurate, complete and transmural, so that the ablation forceps are one of effective methods for treating atrial fibrillation. The ablation effect influencing factors of pulse ablation include voltage, current, pulse width, frequency and the like, which are mostly emitted by an ablation instrument within a rated safety range, more of the operators are ablated by experience or equipment preset values in the operation, and the control of the process only consists in determining whether the clamping of target ablation tissues is tightly attached reliably or not by naked eyes, so that the uncertainty is large.

Meanwhile, in the existing ablation forceps, due to the relative movement of the two forceps arms, a reserved gap exists, and when the target ablation tissue is clamped actually, the situation that part of tissue enters the reserved gap is found, so that the target tissue cannot be completely ablated.

And after pulse energy ablation is adopted, irreversible electroporation can be generated on cells, but the result of the irreversible electroporation of the cells can not be intuitively detected and observed immediately, so that the effect of pulse ablation can not be effectively determined. Therefore, to reduce the likelihood of surgical failure, it is desirable to increase the reliability of the ablation procedure as much as possible while avoiding the situation of missed ablations. Current pulse ablation forceps do not meet practical needs.

In view of this, a new pulse ablation system and control method are needed to perform surgical pulse ablation.

Disclosure of Invention

In order to overcome the above problems in the prior art, the present invention provides a high-efficiency and safe pulse ablation system and a control method thereof, which can avoid the situation of ablation missing.

One aspect of the present invention provides a pulse ablation system comprising a pulse ablation clamp and a pulse ablator coupled to the pulse ablation clamp, wherein,

The pulse ablation forceps comprise a forceps body and a jaw part which is arranged on the forceps body and consists of a fixed forceps arm and a movable forceps arm parallel to the fixed forceps arm, wherein the jaw part is used for realizing the purpose of clamping or releasing target ablation tissues through the movement of the movable forceps arm relative to the fixed forceps arm, the forceps body comprises a chute, the fixed forceps arm is fixedly connected to the far end of the chute, the movable forceps arm is close to or far away from the fixed forceps arm along the chute, n first electrodes are arranged on the movable forceps arm from the far end to the near end along the extending direction of the jaw part, n+1 second electrodes are arranged on the fixed forceps arm, n is more than or equal to 2, the projection of each first electrode on the fixed forceps arm is positioned between the two second electrodes in the direction perpendicular to the extending direction of the fixed forceps arm, all the first electrodes are arranged outside the chute, and at least one part of n+1th second electrodes are arranged in the chute;

the pulse ablation instrument comprises a pulse generation module, a central control module and an interaction control module, wherein at least one of the pulse ablation clamp and the pulse ablation instrument comprises an impedance detection module;

The impedance detection module is used for detecting first impedance between the first electrode on the movable clamp arm and the second electrode on the fixed clamp arm, detecting second impedance between two adjacent electrodes on the same side clamp arm and feeding back to the central control module;

The pulse generation module is used for generating and sending pulse signals to each of the first electrode and the second electrode independently under the control of the central control module;

The central control module is connected with the impedance detection module, the pulse generation module and the interaction control module and is used for receiving information of other modules for processing and feeding back and/or displaying the processed information;

the interaction control module is used for displaying information and receiving control instructions of a user.

Preferably, the impedance detection module detects first impedances between n first electrodes on the movable clamp arm and n+1 second electrodes on the fixed clamp arm respectively in such a way that the resistance between the m first electrodes on the movable clamp arm and the m second electrodes on the fixed clamp arm and the resistance between the m first electrodes on the movable clamp arm and the m+1 second electrodes on the fixed clamp arm are equal to or greater than 1 and less than or equal to n.

More preferably, the central control module compares the first impedance detected by the impedance detection module with a first threshold value to select a working electrode, wherein,

First determining a second electrode S_a and a second electrode S_b of critical thresholds at two ends of the fixed clamp arm, wherein the second electrode S_a and the second electrode S_b meet the following conditions that i) the resistance between the second electrode S_a and the first electrode M_a and the resistance between the second electrode S_b and the first electrode M_b-1 are all smaller than or equal to the first threshold, wherein 1≤a≤b≤n+1, ii) the second electrode S_a-1 does not exist, or when the second electrode S_a-1 exists, the resistance between the second electrode S_a-1 and the first electrode M_a-1 is larger than the first threshold, and iii) the second electrode S_b+1 does not exist, or when the second electrode S_b+1 exists, the resistance between the second electrode S_b+1 and the first electrode M_b is larger than the first threshold;

Then, all the second electrodes among the second electrode S_a, the second electrode S_b, the second electrode S_a, and the second electrode S_b, the first electrode M_a, the first electrode M_b-1, and all the first electrodes among the first electrode M_a and the first electrode M_b-1 are used as working electrodes.

More preferably, when a >1, further comparing whether the resistance between the second electrode S_a and the first electrode M_a-1 is equal to or less than the first threshold value, when the resistance between the second electrode S_a and the first electrode M_a-1 is equal to or less than the first threshold value, the first electrode M_a-1 is also used as a working electrode;

When b < n+1, further comparing whether the resistance between the second electrode S_b and the first electrode M_b is equal to or less than the first threshold value, and when the resistance between the second electrode S_b and the first electrode M_b is equal to or less than the first threshold value, the first electrode M_b is also used as a working electrode.

Preferably, the central control module compares the second resistance between the j-th electrode and the j+1-th electrode on the same side forceps arm with a second threshold value, and when the second resistance is smaller than the second threshold value, the central control module sends an instruction to the pulse generation module to enable the pulse generation module to inhibit electrode discharge according to the following mode:

and when j is larger than or equal to n/2, the j+1th electrode is forbidden to discharge, and when j is smaller than n/2, the j electrode is forbidden to discharge.

Preferably, the kth first electrode and the kth second electrode and the kth+1th second electrode form electrode pairs, the pulse generation module sends pulse signals to one or more electrode pairs respectively according to the instruction of the central control module, so that the first electrode in the electrode pairs is one of positive electrodes and negative electrodes, and the second electrode in the electrode pairs is the other of positive electrodes and negative electrodes, wherein k is greater than or equal to 1 and less than or equal to n.

Preferably, the pulse ablation apparatus further comprises a pressure detection module, wherein the pressure detection module is used for detecting the pressure born by the first electrode on the movable clamp arm and the second electrode on the fixed clamp arm, and feeding back the pressure to the central control module.

More preferably, the central control module compares whether the pressure difference value received by the first electrode and the second electrode is less than or equal to 5% in the following manner, and feeds back the result to the interactive control module:

When n is an odd number, respectively comparing the pressure applied to the (n+1)/2 th second electrode, the (n+3)/2 nd second electrode and the (n+1)/2 nd first electrode on the movable clamp arm;

When n is an even number, the pressure applied by the n/2 th second electrode, the (n/2) +1 th second electrode and the n/2 th first electrode on the movable clamp arm are respectively compared.

Preferably, the pulse ablation forceps comprise an identification module, the identification module contains parameter information of the pulse ablation forceps, the pulse ablation instrument comprises a host identification module, and the host identification module is connected with the central control module and is used for identifying the identification module according to instructions of the central control module so as to acquire the parameter information of the pulse ablation forceps.

Another aspect of the present invention provides a method of controlling the above pulsed ablation system, the method comprising:

The method comprises the steps of S1) selecting a working electrode, wherein the central control module sends an instruction to the impedance detection module, the impedance detection module detects first impedance between the first electrode on the movable clamp arm and the second electrode on the fixed clamp arm and feeds the first impedance back to the central control module, and the central control module compares the first impedance with the first threshold value to determine the working electrode;

s2) working electrode pre-detection, wherein the central control module sends an instruction to the impedance detection module, the impedance detection module detects second impedance between two adjacent working electrodes on the same side clamp arm and feeds the second impedance back to the central control module, and the central control module compares the second impedance with the second threshold value to determine whether the working electrodes meet a discharge standard or not;

S3) discharging control, wherein the central control module sends an instruction to the pulse generation module, and the pulse generation module sends a pulse signal to the working electrode.

The pulse ablation system and the control method thereof of the invention have the following technical effects:

1) Compared with the ablation by the radio frequency energy, the ablation forceps in the pulse ablation system provided by the invention has the advantages that the boundary/range of the pulse ablation is obvious, the irreversible electroporation can be caused to the target ablation tissue only when the boundary/range of the pulse ablation reaches the voltage threshold, the myocardial tissue can be selectively ablated, other organs are not damaged accidentally as easily as the radio frequency ablation, the influence on the tissue at the non-ablation part is avoided, and the generation of complications is greatly reduced. The pulse electric field energy is adopted for ablation, the action time is short, the thermal effect can be hardly generated, cold saline is not needed for pouring and cooling, the restorability is faster, and compared with the cryoablation, the product structure is simpler.

2) The pulse ablation forceps in the pulse ablation system adopt two parallel push-pull clamping forceps arms, compared with the scissor type forceps arms, the target ablation tissue can be more easily kept between the two forceps arms, the fixed forceps arms are located at the far ends compared with the movable forceps arms, the target ablation tissue is controlled between the fixed forceps arms and the movable forceps arms and held by the fixed forceps arms, when the movable forceps arms are pushed to clamp the target ablation tissue, the change of the target ablation tissue is mainly controlled at the opposite near ends (near to one ends of the movable forceps arms), and the target ablation tissue can be more easily observed by operators, so that whether the target ablation tissue is clamped or not is perceived by naked eyes.

3) In practical applications, the inventor finds that when the first electrode and the second electrode are arranged in a one-to-one correspondence manner, that is, when the projection of the first electrode coincides with the second electrode in the direction perpendicular to the extending direction of the fixed clamp arm, and the upper electrode and the lower electrode are respectively arranged as the positive electrode and the negative electrode to perform low-voltage discharge (800-1200V), an ablation region gap (such as O in fig. 6) is easy to appear between the movable clamp arm and the fixed clamp arm. According to the invention, the first electrode is arranged to be less than the second electrode, and in the direction perpendicular to the extension direction of the fixed clamp arm, the projection of the first electrode is positioned between the two second electrodes, namely, the first electrode and the second electrode are arranged in a staggered way, so that the ablation range can be controlled more conveniently and efficiently by controlling the number and the positions of the discharged electrodes, the risk of generating an arc due to the too close distance between the first electrode and the second electrode is avoided, the notch of the ablation area can be reduced or eliminated, and the ablation is more complete.

4) The inventor finds that although the operator can place the target ablation tissue at the center of the forceps arms as much as possible during the operation, due to the volume of the target ablation tissue and the like, pushing the movable forceps arms during clamping the target ablation tissue can cause the target ablation tissue to be compressed/extruded to two sides along the fixed forceps arms, so that the target ablation tissue can enter the chute, and on the conventional ablation forceps, the electrode is usually spaced from the chute and is not arranged in the chute, so that the ablation leakage can be caused. In order to solve the problem, the pulse ablation forceps in the pulse ablation system are provided with n+1 second electrodes on the fixed forceps arms, and the n+1 second electrodes are at least partially arranged in the sliding grooves, so that the target ablation tissues entering the sliding grooves are ablated, and the leakage of the ablation is prevented. And the first electrode on the movable clamp arm is arranged outside the chute, so that the risks of arc and short circuit caused by the fact that the first electrode and the second electrode are arranged in the chute and are too close to each other are avoided.

5) In addition, due to the distance between electrodes, pulse intensity, etc., the pulse electric field generated between the positive and negative electrodes may not cover all preset ablation ranges during the ablation, as shown in fig. 10, 12, 17, and 23, there is an ablation gap M. According to the invention, the insulating protrusions are arranged between the adjacent electrodes of the fixed clamp arm and/or the movable clamp arm, so that the tissue to be ablated at the notch position can be supported and enter the range of the pulse electric field, thereby compensating the ablation notch and avoiding ablation leakage.

6) The control method can determine the positions and the number of the electrodes clamping the target ablation tissue by detecting the impedance between the first electrode and the second electrode, so as to determine the working electrode and avoid the occurrence of short circuit and other conditions caused by discharge between the electrodes not clamping the target ablation tissue. The working electrode is pre-detected by detecting the impedance between the adjacent electrodes on the same side forceps arm, and the bonding condition of the working electrode and the target ablation tissue is judged, so that the occurrence of short circuit and the like caused by the fact that the working electrode is not firmly bonded with the target ablation tissue is avoided. In addition, the invention can also set pressure reminding, detect whether the pressure difference between the first electrode and the second electrode is in a certain range, and preliminarily judge the clamping condition of the ablation forceps on the target ablation tissue. In addition, in the case of performing discharge ablation, the first electrode and the second electrode preferably form an electrode pair to perform discharge, so that an ablation notch between the first electrode and the second electrode can be reduced and eliminated. The control method of the present invention also includes discharge protection control to avoid adverse consequences of too high pulse signal application to the tissue. In summary, the control method of the invention is safe and efficient, and can avoid the occurrence of short circuit, ablation notch and the like as much as possible.

Drawings

FIG. 1 is a schematic view of a pulse ablation clamp according to one embodiment of the present invention;

FIG. 2 is an exploded view of a pulse ablation clamp according to one embodiment of the present invention;

FIG. 3 is a schematic view of a fixed jaw arm and a movable jaw arm of a pulse ablation clamp in accordance with one embodiment of the present invention;

FIG. 4 is a schematic view of a fixed jaw arm and a movable jaw arm of a pulse ablation clamp in accordance with another embodiment of the present invention;

FIG. 5 is a schematic view of a prior art ablation forceps holding a pig heart ear;

FIG. 6 is a simulated view of the ablation region of a prior art pulse ablation forceps;

FIG. 7 is a simulated view of an ablation region of a pulse ablation clamp in accordance with one embodiment of the present invention;

FIG. 8 is a schematic diagram of the configuration of the first and second electrodes in the fixed and movable arms of a pulse ablation forceps according to an embodiment of the invention;

FIG. 9 is a schematic illustration of electric field lines of one mode of ablation of the pulse ablation forceps shown in FIG. 8;

FIG. 10 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 9;

FIG. 11 is a schematic illustration of electric field lines of another ablation pattern of the pulse ablation forceps shown in FIG. 8;

FIG. 12 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 11;

FIG. 13 is a schematic view of electric field lines of another ablation pattern of the pulse ablation forceps shown in FIG. 8;

FIG. 14 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 13;

FIG. 15 is a schematic view of electric field lines of another ablation pattern of the pulse ablation forceps shown in FIG. 8;

FIG. 16 is a schematic illustration of the ablation region resulting from superposition of the ablations shown in FIGS. 13 and 15;

FIG. 17 is a simulation of ablation of a potato by a pulse ablation forceps in accordance with one embodiment of the invention;

FIG. 18 is a pulse ablation clamp in accordance with one embodiment of the invention wherein the fixed and movable clamp arms include insulative projections thereon;

FIG. 19 is a schematic view of electric field lines of one mode of ablation of the pulse ablation forceps of FIG. 18;

FIG. 20 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 19;

FIG. 21 is a schematic view of the configuration of the first and second electrodes in the fixed and movable arms of a pulse ablation forceps according to another embodiment of the invention;

FIG. 22 is a schematic diagram of electric field lines of one mode of ablation of the pulse ablation forceps of FIG. 21;

FIG. 23 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 22;

FIG. 24 is a schematic view of electric field lines of another ablation pattern of the pulse ablation forceps of FIG. 21;

FIG. 25 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 24;

FIG. 26 is a schematic diagram of an electric field of another ablation modality of the pulsed ablation clamp of FIG. 21;

FIG. 27 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 26;

FIG. 28 is a pulse ablation clip according to an embodiment of the invention wherein the fixed clip arms include insulative protrusions thereon;

FIG. 29 is a schematic view of electric field lines of one mode of ablation of the pulse ablation forceps of FIG. 28;

FIG. 30 is a schematic illustration of an ablation region produced by the ablation pattern shown in FIG. 29;

FIG. 31 is a schematic diagram of a pulse ablation system according to an embodiment of the present invention;

FIG. 32 is a flow chart of a control method according to an embodiment of the present invention;

FIG. 33 is a schematic diagram of a discharge protection circuit according to the present invention;

Fig. 34 is a schematic diagram of a circuit for real-time acquisition of pulse current to calculate ablation energy in accordance with the present invention.

Detailed Description

Definition of the definition

Distal side in this specification, when reference is made to "distal" to the device of the invention, the term refers to the side relatively remote from the user. For the jaw portion of the present invention, "distal" refers to the side that is distal from the chute.

Proximal-in this specification, when reference is made to "proximal" to a device describing the invention, the term refers to the side that is relatively close to the user. For the jaw portion of the present invention, "proximal" refers to the side proximate the chute.

Distal end in this specification, when describing a system or device of the present invention reference is made to "distal end," the term generally refers to the end that is relatively remote from the user. For the jaw portion of the present invention, "distal" refers to the end that is distal from the chute.

Proximal end in this specification, when reference is made to a "proximal end" in describing a system or device of the present invention, the term generally refers to the end that is relatively close to the user. For the jaw portion of the present invention, "proximal" refers to an end near the chute.

In this specification, "a number of" means more than one, i.e., 2 or more, for example, 2, 3, 4, 5, 6, 7, etc.

The terms "mounted," "connected," "secured," and the like are to be construed broadly and may be, for example, fixedly connected or detachably connected or integrally formed, mechanically connected or electrically connected, directly connected or indirectly connected via an intermediate medium, in communication between two elements or in an interaction relationship between two elements, unless otherwise specifically defined. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

The term "electroporation" refers to the application of an electric field to a cell membrane to alter the permeability of the cell membrane to the extracellular environment. As used herein, the term "irreversible electroporation" refers to the application of an electric field to a cell membrane to permanently alter the permeability of the cell membrane to the extracellular environment. For example, cells undergoing irreversible electroporation can observe the formation of one or more pores in their cell membrane that remain after removal of the electric field.

Preferred embodiments of the present invention will be described below with reference to the accompanying drawings, and it will be understood by those skilled in the art that the embodiments or examples described below with reference to the drawings are only illustrative of the best mode for carrying out the present invention, and do not limit the scope of the present invention to these embodiments. The present invention is capable of numerous modifications and variations in light of the embodiments described below. Such modifications and variations are intended to be included within the scope of the present invention.

Fig. 1 and 2 show a schematic view of a pulse ablation forceps 100 according to an embodiment of the invention, which is a parallel push-pull type ablation forceps for ablation with pulse energy, comprising a forceps body and a jaw section mounted on the forceps body, which jaw section is composed of a fixed forceps arm 3 and a movable forceps arm 4 parallel to the fixed forceps arm 3, the jaw section being capable of clamping or releasing target ablation tissue by movement of the movable forceps arm 4 relative to the fixed forceps arm 3. The clamp body comprises a chute 23, a fixed clamp arm 3 is fixedly connected to the far end of the chute 23, and a movable clamp arm 4 is close to or far away from the fixed clamp arm 3 along the chute 23. The pulse ablation forceps 100 of the invention adopts two forceps arms 3 and 4 which are clamped in parallel in a push-pull manner, compared with the scissor type forceps arms, the target ablation tissue can be more easily kept between the two forceps arms 3 and 4, the fixed forceps arm 3 is positioned at a far end compared with the movable forceps arm 4, the target ablation tissue is controlled between the fixed forceps arm 3 and the movable forceps arm 4 and is supported by the fixed forceps arm 3, and when the movable forceps arm 4 is pushed to clamp the target ablation tissue, the change of the target ablation tissue is mainly controlled at the opposite near end (the end close to the movable forceps arm 4), so that the target ablation tissue can be more easily observed by an operator, and thus, whether the tissue is clamped or not is perceived by naked eyes.

The structure for moving the movable jawarms 4 along the runners 23 toward and away from the fixed jawarms 3 is known and readily accomplished by those skilled in the art, for example CN102198012a discloses moving the movable jaw toward and away from the fixed jaw by a push rod, and the invention is not limited in this regard.

As just one example, the present invention provides a structure in which the pulse ablation forceps 100 of the present invention includes a handle 1, an extension rod 2, a fixed forceps arm 3, and a movable forceps arm 4. The extension rod 2 is connected with the handle 1 and extends distally, and a chute 23 is arranged on the extension rod 2.

The handle 1 includes a handle housing 11, a push-pull member 12, and a button post 13. The handle shell 11 is provided with a holding part, and the holding part can be provided with anti-skid patterns for improving friction force and facilitating holding. The holding part is matched with the push-pull piece 12, so that the use of the pulse ablation forceps is convenient for the operator, in the use process, the palm of the operator contacts with the push-pull piece 12, the finger presses the holding part, and the palm can push the push-pull piece 12 forcefully to realize the movement of the movable forceps arm 4, the locking of the pulse ablation forceps 100 and the like. The push-pull member 12 is partially exposed to the handle housing 11 and is connected to the extension rod 2 through the handle housing 11. Pushing the push-pull member 12 will move the inner tube 21 of the extension rod 2, thereby pushing the movable jawarm 4 to move relative to the fixed jawarm 3. The push-pull member 12 includes a push handle 121, a first spring 122, and a second spring 123. The pushing handle 121 pushes the movable clamp arm 4 to move, and the first spring 122 and the second spring 123 play a reset role. During the proximal-to-distal movement of the movable jawarm 4, i.e., the pushing of the movable jawarm 4 from away from the fixed jawarm 3 to toward the fixed jawarm 3, the first spring 122 is forced to compress and the second spring 123 is stretched. The handle housing 11 is provided with a button post 13. In one embodiment of the present application, the button post 13 is a fixed position limit post, and a limit portion and a release portion (not shown) are provided on the push-pull member 12. From the free state of the movable clamp arm 4 of the pulse ablation clamp 100 to the state before the push-pull piece 12 is pushed to reach the preset position, the button column 13 is limited in the corresponding hole of the handle shell 11 by the limiting part and cannot be ejected from the handle shell 11, and when the push-pull piece 12 is pushed to reach the preset position, the button column 13 slides over the limiting part to reach the releasing part, and at the moment, the button column 13 ejects the handle shell 11 to form the limit, so that the pulse ablation clamp 100 is changed into the limiting fixed state, and the pulse ablation clamp 100 is locked. In the above embodiment, the first spring 122 is connected with the handle housing 11 and the inner tube 21 of the extension rod 2, and can provide the elastic force required by the rebound of the inner tube 21, while the second spring 123 is abutted against one end of the handle 1 far away from the extension rod 2, and can still provide a constant elastic force within a certain range after the button column 13 provides limiting, so as to solve the clamping ablation of heart tissues with different thicknesses, so that the operator does not need to worry about the operation difficulty caused by the difference of heart wall thicknesses of various patients, effectively reduces the operation difficulty, protects the tissues to be ablated with different thicknesses from being damaged by the clamping force, and can form the surface of the tissue to be ablated with effective adhesion. When the button column 13 is pressed after the ablation is finished, the movable clamp arm 4 automatically pushes the extension rod 2 back under the action of the double-spring structure, and the extension rod is restored to the initial position, so that the ablation at the next position can be performed. After the button post 13 is locked into the handle 1 to form automatic limit, the thickness of a clamping object between the fixed clamp arm 3 and the movable clamp arm 4 can be between 0mm and 20mm under the action of the double-spring structure. In the present application, the clamping force between the movable jawarm 4 and the fixed jawarm 3 is provided by the elastic force of the two springs 122 and 123. Further, in other embodiments of the present application, the button post 13 is an actuating device, in which embodiment the handle 1 may further include a rotating device provided in the handle housing 11, the rotating device being an electric device actuated by the button post 13, and the electric device pushing the movable clamp arm 4 to move until the reaction pressure from the two springs 122 and 123 applied to the movable clamp arm 4 reaches a preset value after the button post 13 is pressed. After the ablation is finished, the rotating device can be reversely moved by pressing the button column 13 again, so that the movable clamp arm 4 is driven to be far away from the fixed clamp arm 3. In addition, the handle 1 comprises a connecting cable for connecting an external ablation device, so as to realize electrical connection.

The extension rod 2 is used to extend the length of the ablation forceps 100 for facilitating the insertion of the forceps arms into the body for manipulation, and includes an inner tube 21, an outer tube 22 and a chute 23. The outer tube 22 is fixedly connected with the handle housing 11, and a chute 23 is fixed at the distal end of the outer tube 22. The chute 23 is a member having an opening formed by two side walls and an inner wall connecting the two side walls, and one side of the fixed jaw arm 3 and the movable jaw arm 4 is entered from the opening and connected to the chute 23. In a direction perpendicular to the outer tube 22, there is a distance from the opening of the chute 23 to its inner wall so that the chute 23 has a depth to accommodate the fixed jaw arm 3 and the sliding jaw arm 4. And along the direction in which the outer tube 22 extends, the chute 23 has a length to accommodate the sliding of the inner tube 21 and the movable jawarms 4. The cross-sectional shape of the chute 23 may be a semicircular shape, a square shape, a rectangular shape, or a shape formed of two straight lines connected in an arc shape, which is open and hollow, in a direction perpendicular to the outer tube 22, or may be other shapes that can be adapted to the shape of the outer tube 22. The fixed clamp arm 3 is fixedly connected to the distal end of the sliding groove 23, the outer tube 22 is sleeved outside the inner tube 21, the inner tube 21 can move relative to the outer tube 22, and the movable clamp arm 4 is fixed to the distal end of the inner tube 21. The inner tube 21 is connected to the push-pull member 12 by a first spring 122 and is movable relative to the outer tube 22 by the push-pull member 12. The movement of the inner tube 21 relative to the outer tube 22 drives the movable jawarms 4 to slide in the slide grooves 23, and the movable jawarms 4 move in parallel relative to the fixed jawarms 3. Further, the inner tube 21 and the outer tube 22 can be made of metal shaped flexible tubes, and a doctor can manually adjust the bending form according to the specific tissue structure position so as to adapt to various surgical conditions.

As shown in fig. 3 and 4, the fixed jaw arm 3 and the movable jaw arm 4 may be provided in an arc shape having a length corresponding to an arc shape, or in a straight line shape having the same length. In addition to the above-described shape, any suitable shape may be provided according to actual needs, as long as the fixed jaw arm 3 and the movable jaw arm 4 are arranged in parallel and can clamp the target ablation tissue. In one embodiment, the length of the fixed jaw arm 3 and the movable jaw arm 4 may be 5-10cm along the direction in which the jaw portion extends (X direction in fig. 4), and when both are arc-shaped, the arc may be 1-15 °. The angle of the fixed jawarm 3 and the movable jawarm 4 with respect to the plane of the handle housing 11 is the same, and may be 90-120 °.

The fixed clamp arm 3 and the movable clamp arm 4 are oppositely arranged, n (n is more than or equal to 2) first electrodes 43 are arranged on the movable clamp arm 4 along the extending direction of the jaw part from the far end to the near end, n+1 second electrodes 33 are arranged on the fixed clamp arm 3, each first electrode 43 and each second electrode 33 are respectively and electrically connected with a pulse generator through leads, and each first electrode 43 and each second electrode 33 can be respectively arranged to be non-electrified, negative or positive. The first electrode 43 is disposed outside the chute 23, and at least a portion of the n+1th second electrode of the plurality of second electrodes 33, which is adjacent to the chute 23, is disposed inside the chute 23. As shown in fig. 3 and 4, at least a part of the second electrode 33 indicated by a broken line frame falls within the chute 23. That is, along the extending direction (Y-axis direction in fig. 4) of the chute 23, the projection of the chute 23 onto the movable jawarm 4 does not cover the first electrode 43, while the projection of the chute 23 onto the fixed jawarm 3 covers at least a portion of the (n+1) th second electrode near the chute 23. Along the extending direction (X-axis direction in fig. 4) of the fixed clamp arm 3, the depth of the chute is generally 6-8 mm, in a preferred embodiment, the length of the second electrode 33 near the chute 23 extending into the chute 23 is 1-4mm, and the distance between the end of the (n+1) th second electrode near the chute and the inner wall of the chute is 2-4mm.

In practical application, due to the volume of the target ablation tissue, the movable clamp arm 4 is pushed during clamping the target ablation tissue, so that the target ablation tissue is compressed/extruded to two sides of the clamp arm along the fixed clamp arm 3, and the target ablation tissue may enter the chute 23. In fig. 5, taking the pig heart auricle as an example, it can be seen that when the ablation forceps clamp the heart auricle, part of tissue is clamped and extruded into the space of the chute, and in the ablation forceps of the prior art, the condition of ablation leakage occurs because no electrode exists in the chute. The invention realizes the ablation of the target ablation tissue entering the chute 23 and prevents the problem of ablation leakage by arranging a plurality of second electrodes 33 on the fixed forceps arm 3 and arranging at least one part of the second electrodes close to the chute 23 in the chute 23. And, each electrode on the fixed jaw arm 3 and the sliding jaw arm 4 is connected with a corresponding wire, which is abutted against the inner wall of the chute 23 and is led into the extension rod 2 through the chute 23, and which occupies a part of the space in the chute 23. The first electrode 43 on the sliding clamp arm 4 is arranged outside the chute 23, so that the problems of breakdown and the like caused by too close distance between the electrode and the inner wall of the chute 23 and/or a wire in the chute 23 due to the fact that the electrode on the sliding clamp arm 4 extends into the chute 23 can be prevented.

In addition, as shown in fig. 6, if the first electrode 43 and the second electrode 33 are in one-to-one correspondence up and down, that is, in the direction perpendicular to the extending direction of the jaw portion, the projection of the first electrode 43 on the fixed jaw arm 3 coincides with the second electrode 33, and when the first electrode 43 and the second electrode 33 are respectively positive and negative, a notch O of the ablation region is likely to occur between the fixed jaw arm 3 and the movable jaw arm 4 when the low-voltage discharge (800-1200V) is performed. In the present invention, however, the first electrodes 43 and the second electrodes 33 are arranged alternately, i.e., in a direction perpendicular to the extension of the fixed jaw 3, the projection of each first electrode 43 onto the fixed jaw 3 is located between two second electrodes 33, e.g., for the fixed jaw 3, The electrodes on the movable clamp arm 4 are numbered, from the direction far from the extension rod 2 to the direction close to the extension rod 2, the n first electrodes 43 on the movable clamp arm 4 are sequentially M₁、M₂、M₃……M_n, the n+1 second electrodes 33 on the fixed clamp arm 3 are sequentially S₁、S₂、S₃……S_n+1, then in the direction perpendicular to the extension direction of the fixed clamp arm 3, the projection of M₁ on the fixed clamp arm 3 is positioned between S₁ and S₂, the projection of M₂ on the fixed clamp arm 3 is positioned between S₂ and S₃, and so on, the projection of M_n on the fixed clamp arm 3 is positioned between S_n and S _n+1, and M_n does not extend into the sliding groove 23, and at least one part of S _n+1 falls into the sliding groove 23. By this arrangement, as shown in fig. 7, the pulse ablation forceps 100 of the present invention can reduce or eliminate the notch O at the time of low-voltage discharge. Fig. 17 is a simulated ablation performed on potatoes using the same conditions, and it can be seen that no ablation notch appears at the intermediate position between the first electrode 43 and the second electrode 33.

The pulse ablation forceps 100 of the invention can prevent the problems of ablation leakage and arc generation in the chute 23 and between the two forceps mouths by arranging the first electrode 43 and the second electrode 33 as above, and the arrangement of the segmented electrodes can control the ablation range more conveniently and efficiently by controlling the number and the positions of the discharged electrodes. For example, when the clamped target ablation tissue does not cover all of the first electrodes 43 and the second electrodes 33, the target ablation tissue may be ablated using only the first electrodes 43 and the second electrodes 33 covered by the target ablation tissue.

In a preferred embodiment of the invention, n is 5, i.e. 5 first electrodes 43 are provided on the sliding jaw arm 4 and 6 second electrodes 33 are provided on the fixed jaw arm 3. In a preferred embodiment of the present invention, the adjacent first electrodes 43 are arranged at equal intervals, and/or the adjacent second electrodes 33 are arranged at equal intervals, preferably in a range of 1.5 to 4mm. In a preferred embodiment of the present invention, each of the first electrodes 43 and/or the second electrodes 33 has the same length and area, where the length is the distance each of the first electrodes 43 and the second electrodes 33 extends in the direction in which the jaw portions extend, and the area is a cross-section with a plane parallel to the direction in which the jaw portions extend, and the cross-sectional area of each of the first electrodes 43 and the second electrodes 33, i.e., the area of the electrode's contact surface with the target ablation tissue. In a preferred embodiment of the invention, the first electrode 43 and the second electrode 33 have a length of 6mm and an area of 16mm². By arranging the first electrode 43 and the second electrode 33 having the above lengths and areas at equal intervals, not only the target ablation tissue entering the chute can be ablated, but also the ablation effect of the target ablation tissue clamped between the sliding clamp arm 4 and the fixed clamp arm 3 can be more uniform and better. The shapes of the first electrode 43 and the second electrode 33 are not particularly limited, and in a preferred embodiment of the present invention, both the first electrode 43 and the second electrode 33 are elliptical. Under the high voltage condition, the tip, the bulge, the edge angle and the like of the electrode can cause the problem of tip discharge, so that the safety is reduced due to the generation of electric arcs, and therefore, the original rectangular electrode plate is subjected to chamfering treatment, so that the rectangular electrode plate is elliptical, and the problem of tip discharge can be effectively prevented.

In one embodiment of the present invention, as shown in fig. 8, the sliding jaw arm 4 includes a first jaw housing 41, a first insulating layer 42 disposed on the first jaw housing 41, and a first electrode 43 disposed within the first insulating layer 42 having a face for contacting the target ablation tissue, the first electrode 43 including first electrodes 431, 432, 433, 434, and 435 in this embodiment. Accordingly, the fixed jaw arm 3 includes a second jaw housing 31, a second insulating layer 32 disposed on the second jaw housing 31, and a second electrode 33 disposed within the second insulating layer 32 having a face for contacting the target ablated tissue, the second electrode 33 including, in this embodiment, second electrodes 331, 332, 333, 334, 335, and 336. Wherein the projection of the first electrode 431 onto the fixed jawarm 3 is located between the second electrodes 331 and 332 in a direction perpendicular to the fixed jawarm 3 (i.e., the Y-axis direction in fig. 8), the projection of the first electrode 432 onto the fixed jawarm 3 is located between the second electrodes 332 and 333, and so on, the projection of the first electrode 435 onto the fixed jawarm 3 is located between the second electrodes 335 and 336, and none of the first electrodes 43 falls into the chute 23 (not shown), while at least a portion of the second electrode 336 is disposed within the chute 23.

According to the pulse ablation forceps shown in fig. 8, different modes of ablation may be employed depending on the size of the target ablated tissue. As shown in fig. 9 and 10, when the target ablation tissue D covers all of the first electrodes 431, 432, 433, 434, 435 and the second electrodes 331, 332, 333, 334, 335, 336, all of the first electrodes and the second electrodes participate in the ablation. For example, pulse energy is delivered to the target ablation tissue D by transmitting electrical signals to all first electrodes 431, 432, 433, 434, 435, by the pulse generator, making them negative, and transmitting electrical signals to all second electrodes 331, 332, 333, 334, 335, 336, making them positive (all first electrodes 43 can also be made positive, all second electrodes 33 are made negative). All electric field lines between the first electrode and the second electrode are shown in fig. 9, and the formed ablation region T is shown in fig. 10, and it can be seen that even if the target ablation tissue D enters the chute 23 (not shown) due to volume or extrusion, since at least a portion of the second electrode 336 is located in the chute 23, the formed ablation region T can cover the target ablation tissue D located in the chute 23, thereby avoiding leakage of ablation. Further, as shown in fig. 11 and 12, when the target ablation tissue D covers only a part of the first electrodes 431, 432, 433 and the second electrodes 331, 332, 333, an electric signal is transmitted to the covered first electrodes 431, 432, 433 and the second electrodes 331, 332, 333 by the pulse generator, the first electrodes 431, 432, 433 are made negative, the second electrodes 331, 332, 333 are made positive (the first electrodes 431, 432, 433 may also be made positive, the second electrodes 331, 332, 333 are made negative), and an electric signal is not transmitted to the remaining first electrodes 434, 435 and the second electrodes 334, 335, 336, thereby transmitting pulse energy to the target ablation tissue D. In this case, electric field lines between the first electrodes 431, 432, 433 and the second electrodes 331, 332, 333 are as shown in fig. 11, and an ablation area T is formed as shown in fig. 12, and it can be seen that the ablation area covers only the target ablation tissue D. No electric field is generated between the first electrode 434, 435 and the second electrode 334, 335, 336, avoiding the risk of short-circuiting, arcing, etc. due to the absence of target ablated tissue between the first electrode and the second electrode.

In some embodiments, in the case where the target ablation tissue is thin, only the first electrode or the second electrode may be used for ablation, as shown in fig. 13 and 14, the electric signals are not transmitted to all the first electrodes 431, 432, 433, 434, 435, and the adjacent second electrodes are respectively configured as positive and negative electrodes, in fig. 13, the second electrode 331 is configured as a positive electrode, the second electrode 332 is configured as a negative electrode, the second electrode 333 is configured as a positive electrode, and an electric field is generated between the adjacent second electrodes, so that an ablation region T is formed as shown in fig. 14. Further, as shown in FIG. 15, it is also possible to configure that electric signals are not transmitted to all of the second electrodes 331, 332, 333, 334, 335, 336, adjacent first electrodes are respectively configured as positive and negative electrodes, the first electrode 431 is configured as a positive electrode, the first electrode 432 is configured as a negative electrode, the first electrode 433 is configured as a positive electrode, and an electric field is generated between the adjacent first electrodes to form an ablation region. In addition, when the target ablation tissue is thick, the ablation may not be completely performed by using only one electrode, in which case, in order to avoid incomplete ablation using a single electrode, as shown in fig. 16, a mode of performing ablation by using an adjacent second electrode and performing secondary ablation by using an adjacent first electrode may be configured, so that overlapping of the two ablation areas can avoid missed ablation. Furthermore, while only a portion of the first and second electrodes are shown in fig. 13-16 for ablation, those skilled in the art will appreciate that when the target ablated tissue covers all of the first and second electrodes, the same configuration may be used for all of the first and second electrodes to ablate the target ablated tissue using the manner of ablation shown in fig. 13-16.

As shown in fig. 10 and 12, when the polarities of the first electrode and the second electrode are opposite, since there is a distance between the adjacent two electrodes on the same forceps arm, there may be an area where the electric field lines cannot cover, and thus, a gap M of the ablation area may be generated between the adjacent two electrodes on the same forceps arm, and the target ablation tissue located at the gap M cannot be ablated. Fig. 17 is a simulated ablation on potatoes using the pulse ablation forceps of fig. 8 in the discharge mode of fig. 9, it being seen that a gap M exists between the two electrodes. In order to prevent the problem of missed ablation of the target ablated tissue at the notch M, in one embodiment of the invention, an insulating protrusion is provided between two adjacent electrodes on the same jawarm. The insulating bulge can prop up the target ablation tissue at the notch M to enable the target ablation tissue to enter an ablation area, and therefore ablation leakage can be prevented. The insulating protrusions may be provided only between the adjacent two first electrodes, or only between the adjacent two second electrodes, or between the adjacent two first electrodes and the adjacent two second electrodes. As shown in fig. 18, first protrusions 441, 442, 443, and 444 are respectively disposed between the first electrodes 431, 432, 433, 434, and 435, and second protrusions 341, 342, 343, 344, and 345 are respectively disposed between the second electrodes 331, 332, 333, 334, 335, and 336. As shown in fig. 19 and 20, the first protrusions 441, 442, 443, 444 and the second protrusions 341, 342, 343, 344, 345 prop up the target ablation tissue at the corresponding positions, so that the target ablation tissue originally located at the notch M enters the range of the electric field, falls within the ablation region T, and can be ablated. The shape of the insulating protrusions is not particularly limited, but is preferably an arch shape. The insulating projections have a height in a section in a plane perpendicular to the direction in which the jaw portion extends, i.e., a longest distance from a surface of the insulating projections in contact with the tissue to the opposite jaw, of 5mm or less, and a width of the insulating projections, i.e., a longest distance of the insulating projections in the direction in which the jaw extends, of 3.5mm or less, for example, a spacing between adjacent two of the electrodes.

In another embodiment of the present invention, the pulse ablation forceps of the present invention may have a structure in which only one first electrode is provided on the movable forceps arm 4, a plurality of second electrodes are provided on the fixed forceps arm 3, the first electrode is provided outside the chute 23, i.e., it does not extend into the chute, and at least a portion of the second electrode adjacent to the chute 23 is provided inside the chute 23. Therefore, not only the target ablation tissue falling into the chute 23 can be ablated, but also the arc can not be generated because the first electrode and the second electrode are too close, and meanwhile, the movable clamp arm 4 is provided with only one first electrode, so that the structure is simpler. Fig. 21 shows an example of the above embodiment, which is illustrated with 6 second electrodes, and those skilled in the art will recognize that the number of second electrodes may be greater or less than 6. As shown in fig. 21, only one first electrode 43' is provided on the movable jawarm 4, and 6 second electrodes 33, namely, second electrodes 331, 332, 333, 334, 335, 336 are provided on the fixed jawarm 3. At least a portion of the second electrode 336 extends into the chute 23 (not shown), and the first electrode 43' is disposed outside the chute 23. The length of the first electrode 43 'may be set according to the electrode in the existing ablation forceps in which a single electrode is provided at the single-sided forceps arm, for example, in order to contact as much as possible with the target ablation tissue, the first electrode 43' extends along the extending direction of the sliding forceps arm 4 as long as the end thereof near the chute 23 does not extend into the chute 23. Preferably, the projection of the first electrode 43' onto the fixed jaw arm 3 in a direction perpendicular to the fixed jaw arm 3 covers at least a portion of the second electrode 331 and the second electrode 336 simultaneously, and by this arrangement, the area of the ablation region can be enlarged, and occurrence of missed ablations can be reduced.

The pulse ablation forceps shown in fig. 21 may employ different modes of ablation depending on the size of the target ablated tissue. As shown in fig. 22 and 23, when the target ablation tissue D covers the first electrode 43 'and all the second electrodes 331, 332, 333, 334, 335, 336, the first electrode 43' and all the second electrodes participate in the ablation. For example, pulse energy is delivered to the target ablation tissue D by transmitting an electrical signal to the first electrode 43 'via the pulse generator, making it negative, and transmitting an electrical signal to all of the second electrodes 331, 332, 333, 334, 335, 336, making it positive (the first electrode 43' may also be made positive, and all of the second electrodes negative). The electric field lines between the first electrode 43' and the second electrodes 331, 332, 333, 334, 335, 336 are shown in fig. 22, and the formed ablation zone T is shown in fig. 23, and it can be seen that even if the target ablation tissue D enters the chute 23 (not shown) due to volume or extrusion, the formed ablation zone T can cover the target ablation tissue D located in the chute 23 due to at least a portion of the second electrode 336 being located in the chute 23, thereby avoiding missed ablations. Further, as shown in fig. 24 and 25, when the target ablation tissue D covers only a part of the first electrode 43 'and a part of the second electrodes 331, 332, 333, an electric signal is transmitted to the first electrode 43' and the covered second electrodes 331, 332, 333 by the pulse generator, the first electrode 43 'is made negative, the second electrodes 331, 332, 333 are made positive (the first electrode 43' may be made positive, the second electrodes 331, 332, 333 may be made negative), and no electric signal is transmitted to the remaining second electrodes 334, 335, 336, thereby transmitting pulse energy to the target ablation tissue D. In this case, the electric field lines between the first electrode 43' and the second electrodes 331, 332, 333 are as shown in fig. 24, and the ablation region T is formed as shown in fig. 25, and it can be seen that the ablation region covers only the target ablation tissue D. No electric field is generated between the first electrode 43' and the second electrodes 334, 335, 336, avoiding the occurrence of risks of short circuits, arcing, etc.

In some embodiments, only the second electrode may be used for ablation, as shown in fig. 26, without transmitting an electrical signal to the first electrode 43', the adjacent second electrodes are respectively disposed as positive and negative electrodes, in fig. 26, the second electrode 331 is configured as a positive electrode, the second electrode 332 is configured as a negative electrode, the second electrode 333 is configured as a positive electrode, and an electric field is generated between the adjacent second electrodes, so that an ablation region T is formed as shown in fig. 27. Furthermore, while only a portion of the second electrodes are shown in fig. 26-27 as being used for ablation, those skilled in the art will appreciate that when the target ablated tissue covers all of the second electrodes, the same configuration may be used for all of the second electrodes to ablate the target ablated tissue using the manner of ablation shown in fig. 26-27.

Further, as shown in fig. 23 and 25, when the polarities of the first electrode 43' and the second electrode are opposite, since there may be a region where the electric field lines cannot cover between the adjacent two second electrodes on the fixed jaw arm 3, a notch M of the ablation region may be generated between the adjacent two second electrodes on the fixed jaw arm 3, and the target ablation tissue located at the notch M cannot be ablated. In order to prevent the problem of missed ablation of the target ablated tissue at the notch M, in one embodiment of the invention, an insulating protrusion is provided between adjacent two electrodes on the fixed jaw arm 3. The insulating bulge can prop up the target ablation tissue at the notch M to enable the target ablation tissue to enter an ablation area, and therefore ablation leakage can be prevented. As shown in fig. 29 and 30, second protrusions 341, 342, 343, 344 and 345 are respectively disposed between the second electrodes 331, 332, 333, 334, 335 and 336, and the second protrusions 341, 342, 343, 344 and 345 prop up the target ablation tissue at the corresponding positions, so that the target ablation tissue originally located at the notch M enters the range of the electric field and falls into the ablation region T, thereby being able to be ablated.

In one embodiment of the present invention, the pulsed ablation forceps 100 of the present invention may also include a pressure sensor. When the sliding clamp arm 4 is pushed to move towards the fixed clamp arm 3 to clamp the target ablation tissue, the pressure sensor can sense the pressure on the position and can transmit the pressure to a pressure detection module in a pulse ablation instrument connected with the pulse ablation clamp 100 according to the invention through a lead connected with the pressure sensor, and according to the detected pressure, an operator can pertinently adjust and control the clamping process. The position of the pressure sensor can be set as required. In one embodiment, a pressure sensor is provided at the bottom of each of the first and second electrodes, and when tissue is clamped, the electrode force is transferred to the underlying pressure sensor. In another embodiment, the pressure sensor is arranged in the gap between two adjacent electrodes of the same side jawarms, not connected to the electrodes, in which case the pressure sensor is able to directly sense the pressure conditions during clamping. When an insulating bulge exists between two adjacent electrodes of the clamp arm on the same side, the insulating bulge can be used as a sensing part of the pressure sensor to sense the pressure in the clamping process. In one embodiment of the present invention, the pulse ablation forceps 100 of the present invention further includes a pressure display device, which may be provided on the handle 1 or the pulse ablation instrument, for displaying the pressure sensed by the pressure sensor, so as to facilitate the operation of the operator.

In one embodiment of the present invention, the pulse ablation forceps 100 of the present invention may further include distance sensors provided on the fixed forceps arm 3 and the movable forceps arm 4, respectively, electrically connected to the pulse ablator by conduction connected to each distance sensor for sensing the distance between the fixed forceps arm 3 and the movable forceps arm 4. In a preferred embodiment, the pressure sensors are provided in a plurality of pairs, equally spaced on the fixed jaw arm 3 and the movable jaw arm 4, for measuring the thickness of the target ablation tissue clamped between the fixed jaw arm 3 and the sliding jaw arm 4 and whether the clamping is uniform.

In one embodiment of the present invention, the pulsed ablation forceps 100 of the present invention may further include an impedance detection module. The impedance detection module is provided with a dielectric constant detection unit, the dielectric constant detection unit is used for outputting excitation signals to each first electrode and each second electrode, the excitation signals act on human tissues through each first electrode and each second electrode to generate complex impedance signals, the complex impedance signals are processed to obtain dielectric constant signals, and the degree of adhesion between a plurality of ablation electrodes and the target tissues is detected through the dielectric constant signals. When the dielectric constant signal is smaller than the set threshold, a short circuit phenomenon exists, and the clamping angle is required to be adjusted or the ablation forceps are required to be wiped and replaced. In addition, the impedance detection module can be used for detecting the impedance between each first electrode and each second electrode on the fixed clamp arm and the movable clamp arm, so that the range of the clamped target ablation tissue is judged, the number and the positions of the electrodes for ablation are selected, and the problems of short circuit and the like caused by electrode discharge of the target ablation tissue which is not clamped are avoided. In a preferred embodiment, the impedance detection module is a chip provided at the handle 1 and is connected to the pulse ablator by a wire connected thereto. In addition, the person skilled in the art can also set the impedance detection module at a suitable position of the pulse ablation forceps or the pulse ablation instrument according to the need.

Furthermore, in a preferred embodiment of the present invention, the pulse ablation forceps 100 of the present invention may further include an identification module, which corresponds to the structure of the pulse ablation forceps itself connected thereto, such as the number of electrodes, the length, the area, the electrode spacing on the same side forceps arms and both side forceps arms, the length of the forceps arms, etc. When the pulse ablation forceps 100 are connected with the pulse ablation instrument for ablating target ablation tissues, the pulse ablation instrument can be matched with corresponding parameters such as ablation voltage, pulse width, pulse interval and the like according to the target ablation tissues by identifying the identification module on the pulse ablation forceps 100. For example, the identification module may be a resistive element that may be disposed anywhere on the pulse ablation forceps 100 as long as it does not interfere with the operation of the pulse ablation forceps 100, such as within the handle housing 11. The resistance elements with different resistance values respectively correspond to pulse ablation pliers with different structures, and the pulse ablation instrument identifies the pulse ablation pliers by detecting the resistance values of the resistance elements on the pulse ablation pliers and correspondingly matches parameters such as corresponding ablation voltage, pulse width, pulse interval and the like. In addition, the identification module can be in other suitable forms such as a chip.

Fig. 31 shows a schematic diagram of a pulse ablation system 1000 according to an embodiment of the present invention, which includes an ablation forceps 100 and a pulse ablator 200 electrically connected to the ablation forceps 100. The pulse ablator 200 includes an impedance detection module 230, a pulse generation module 240, an interaction control module 250, and a central control module 260. In a preferred embodiment, the pulse ablator 200 of the present invention further comprises a host computer identification module 210 and a pressure detection module 220. The impedance detection module 230, the pulse generation module 240, the interaction control module 250, and preferably the host identification module 210 and the pressure detection module 220 are electrically connected to the central control module 260, respectively. The impedance detection module 230 may be disposed on the pulse ablation forceps 100 instead of the pulse ablation instrument 200, or the impedance detection module 230 may be disposed in both the pulse ablation forceps 100 and the pulse ablation instrument 200. The impedance detection module 230 is configured to detect a first impedance between a first electrode on the movable jawarm 4 and a second electrode on the fixed jawarm 3, and to detect a second impedance between two adjacent electrodes on the same-side jawarm, and to feed back the first impedance to the central control module 260. The pulse generation module 240 is configured to generate and be capable of transmitting pulse signals to each of the first electrode and the second electrode individually under the control of the central control module 260. The central control module 260 is configured to receive information of other modules, process the information, and feed back and/or display the processed information. The interactive control module 250 is used for displaying information and receiving control instructions from a user, such as a display, a keyboard, a touch screen, etc. The host recognition module 210 is configured to recognize the recognition module on the pulse ablation forceps 100 according to the instruction of the central control module 260 to obtain the relevant parameter information of the pulse ablation forceps 100. The pressure detecting module 220 is configured to detect the pressure applied to the first electrode on the movable jawarm 4 and the second electrode on the fixed jawarm 3, and feed back the pressure to the central control module 260.

In the pulse ablation system 1000 of the present invention, the device architecture of the pulse ablator 200 is configured as a central control module 260 and various functional modules electrically connected thereto via a universal communication bus. The above-described respective modules may use devices or apparatuses known in the art, as long as they can realize the functions of the respective modules, and are not particularly limited.

For example, the central control module 260 is constructed based on a general purpose processor, including a single-core or multi-core microcontroller, or a programmable logic device, which may include an FPGA, that has good stability, low latency, and has the advantage of hardware parallelism, and better computing power than a Digital Signal Processor (DSP), helping to improve the effectiveness of pulsed electric field ablation. In addition, the central control module 260 may further include a random access memory, a read only memory, a digital-to-analog converter, an analog-to-digital converter, a power management chip, a communication chip, and the like.

The communication bus adopts an isolated digital interface (such as an optical coupler isolated SPI) to realize data interaction between the central control module and each functional module, but optionally, the pulse ablation system 1000 can also be additionally provided with an independent wireless communication module (such as a Bluetooth low-power-consumption protocol). That is, the data stream in the pulse ablation system 1000 may be transmitted using any communication means, wireless means such as Wifi, WLAN, bluetooth, etc., and wired means such as fiber optic, wire, USB, serial, etc.

In one embodiment, the acquired data may be presented to the operator via an interactive interaction module 250 (e.g., a display, microphone, speaker, etc.) provided with the pulse ablation system. In addition, the interactive interaction module 250 may also be a touch display screen, physical keys, status indicator lamps, and expandable external input devices (such as a keyboard and a mouse) to implement man-machine interaction with an operator. The interfaces of the above devices are required to meet the electrical isolation requirements of medical devices.

For the pulse generating module 240, it may be configured to generate a high voltage by a switching power supply and output pulses through a power switching device, where the switching power supply includes a high frequency transformer and a rectifying and filtering unit, and the power switching device is controlled by a photoelectric isolation driving circuit, and supports multiple pulse outputs such as square waves.

In the above device architecture, each module is powered by a unified power plane, which includes, for example, a buck-type voltage regulator chip and a low dropout linear regulator, to provide multiple isolated power supplies for the system. The communication interfaces and the power supply links of all the functional modules meet the general requirements of the safety standard of medical and electrical equipment on electrical isolation and electromagnetic compatibility.

The control method of the present invention and the connection and operation of the components in the pulse ablation system 1000 of the present invention are described below with reference to fig. 32. As shown in fig. 32, the control method of the present invention includes the selection of the S1 working electrode, the pre-detection of the S2 working electrode, and the S3 discharge control. In a preferred embodiment, the control method of the present invention may further include an S1-b recognition control and an S1-a pressure reminding step.

Since the size of the target ablation tissue and the positions of the target ablation forceps 100 in the two forceps mouths may be different, and the discharge of the electrode which does not clamp the target ablation tissue may cause short circuit, etc., before formally starting pulse ablation, a working electrode needs to be selected, so that the first electrode and the second electrode which clamp the target ablation tissue are working electrodes, and a subsequent ablation operation is performed. The control method of the present invention thus includes the selection of the S1 working electrode, by controlling the operation of the ablation forceps and associated components of the ablation instrument, to achieve the above-described objectives. In the selection of the working electrode in step S1, the working electrode is selected by clamping the difference in impedance between the first electrode and the second electrode that are not clamping the target ablated tissue. Specifically, when the movable jawarm 4 and the fixed jawarm 3 are both segmented electrodes, the impedance detection module 230 detects the first impedance between the n first electrodes 43 on the movable jawarm 4 and the n+1 second electrodes 33 on the fixed jawarm 3, respectively, in such a manner that the resistance between the m first electrodes 43 on the movable jawarm 4 and the m second electrodes 33 on the fixed jawarm 3, and the resistance between the m first electrodes 43 on the movable jawarm 4 and the m+1 second electrodes 33 on the fixed jawarm 3, are 1≤m≤n. The impedance detection module 230 then sends all the detected first impedances to the central control module 260, and the central control module 260 compares all the first impedances with a first threshold value, and selects a working electrode according to the comparison result. First determining a second electrode S_a and a second electrode S_b which fix critical thresholds at both ends of a clamp arm 3, wherein the second electrode S_a and the second electrode S_b satisfy the conditions that i) the resistance between the second electrode S_a and the first electrode M_a and the resistance between the second electrode S_b and the first electrode M_b-1 are all less than or equal to the first threshold, wherein 1≤a≤b≤n+1, ii) the second electrode S_a-1 is absent, or the resistance between the second electrode S_a-1 and the first electrode M_a-1 is greater than the first threshold when the second electrode S_a-1 is present, and iii) the second electrode S_b+1 is absent, or the resistance between the second electrode S_b+1 and the first electrode M_b is greater than the first threshold when the second electrode S_b+1 is present, and then combining the second electrode S_a, all of the second electrodes S_b, the second electrode S_a and the second electrode S_b, the first electrode M_a, The first electrode M_b-1 and all the first electrodes between the first electrode M_a and the first electrode M_b-1 serve as working electrodes. In a preferred embodiment, when a >1, the resistance between the second electrode S_a and the first electrode M_a-1 is further compared to be equal to or less than the first threshold value, when the resistance between the second electrode S_a and the first electrode M_a-1 is equal to or less than the first threshold value, the first electrode M_a-1 is also used as a working electrode, when b < n+1, the resistance between the second electrode S_b and the first electrode M_b is further compared to be equal to or less than the first threshold value, and when the resistance between the second electrode S_b and the first electrode M_b is equal to or less than the first threshold value, the first electrode M_b is also used as a working electrode.

When all of the first impedances are equal to or less than the first threshold value, it is indicated that the target ablation tissue is sandwiched between all of the first electrodes 43 and the second electrodes 33 (as in the case of fig. 10), and all of the first electrodes 43 and the second electrodes 33 are selected as working electrodes. All of the first electrodes 43 and the second electrodes 33 may be selected as the working electrodes according to the conditions of the second electrodes S_a and S_b for determining the critical threshold. Taking fig. 10 as an example, from the distal end to the proximal end of the jaw portion, a first electrode second electrode 331 to a sixth electrode second electrode 336 are respectively disposed on the fixed jaw arm. For the determination of the electrode S_a near the critical threshold of the distal end on the fixed jawarm, the resistance between the second electrode 331 and the first electrode 431, the resistance between the second electrode 332 and the first electrode 432, the resistance between the second electrode 333 and the first electrode 433, the resistance between the second electrode 334 and the first electrode 434, the resistance between the second electrode 335 and the first electrode 435 are all equal to or less than the first threshold, and the second electrodes 331, 332, 333, 334 and 335 all satisfy the condition i of the second electrode S_a for determining the critical threshold described above. When the second electrode 331 is regarded as S_a, since the second electrode 331 is the first electrode from the distal end to the proximal end on the fixed clamp arm 3, S_a-1 is absent, the condition ii) of the second electrode S_a satisfying the above-mentioned judgment threshold is satisfied, when the second electrode 332 is regarded as S_a, a is 2, S_a-1 is the second electrode 331, and the resistance between the second electrode 331 and the first electrode 431 is equal to or less than the first threshold, the condition ii) of the second electrode S_a not satisfying the above-mentioned judgment threshold is satisfied, the same is true of the second electrode 333, 334 and 335 do not satisfy the condition ii) of the second electrode S_a for the judgment of the critical threshold value described above). Therefore, the conditions i) and ii) of the second electrode S_a that simultaneously satisfy the above-described judgment threshold value are determined as the second electrode S_a of the threshold value. for the determination of the second electrode S_b near the proximal end critical threshold on the fixed jawarm 3, the resistance between the second electrode 332 and the first electrode 431, the resistance between the second electrode 333 and the first electrode 432, the resistance between the second electrode 334 and the first electrode 433, the resistance between the second electrode 335 and the first electrode 434, and the resistance between the second electrode 336 and the first electrode 435 are all equal to or less than the first threshold, the second electrodes 332, 333, 334, 335 and 336 each satisfy the condition i) of the second electrode S_b for determining the critical threshold value described above). When the second electrode 332 is regarded as S_b, S_b+1 is the second electrode 333, the resistance between the second electrode 333 and the first electrode 432 is equal to or less than the first threshold, and the condition iii) of the second electrode S_b that does not satisfy the above-mentioned judgment threshold is satisfied, similarly the second electrode 333, 334. 335 also satisfies the condition iii) of the second electrode S_b for the above-mentioned judgment threshold value), and when the second electrode 336 is regarded as S_b, since the second electrode 336 is the last electrode from the distal end to the proximal end on the fixed jaw arm, S_b+1 does not exist, the condition iii) of the second electrode S_b for the above-mentioned judgment threshold value is satisfied. Therefore, the second electrode 336 satisfying both the conditions i) and iii) of the second electrode S_b for determining the critical threshold is determined as the second electrode S_b for determining the critical threshold. After the second electrodes 331 and 336 are determined to be electrodes of a critical threshold, the second electrodes 331 to 336 and the first electrodes 431 to 435 are selected as working electrodes.

When the partial first impedance is less than or equal to the first threshold, it indicates that the target ablation tissue covers only part of the first electrode and the second electrode, taking the case shown in fig. 12as an example, for determining the electrode S_a near the critical threshold at the distal end on the fixed clamp arm, the resistance between the second electrode 331 and the first electrode 431, the resistance between the second electrode 332 and the first electrode 432, the resistance between the second electrode 333 and the first electrode 433 are all less than or equal to the first threshold, and the second electrodes 331, 332 and 333 all satisfy the condition i of the second electrode S_a for judging the critical threshold described above. When the second electrode 331 is regarded as S_a, since the second electrode 331 is the first electrode S_a-1 on the fixed clamp arm 3 from the distal end to the proximal end, the condition ii) of the second electrode S_a satisfying the above-mentioned judgment threshold value is not present, when the second electrode 332 is regarded as S_a, a is 2, S_a-1 is the second electrode 331, and the resistance between the second electrode 331 and the first electrode 431 is equal to or less than the first threshold value, the condition ii) of the second electrode S_a not satisfying the above-mentioned judgment threshold value is not satisfied, and similarly, the second electrode 333 is also not satisfied with the condition ii) of the second electrode S_a satisfying the above-mentioned judgment threshold value. Therefore, the conditions i) and ii) of the second electrode S_a that simultaneously satisfy the above-described judgment threshold value are determined as the second electrode S_a of the threshold value. For the determination of the second electrode S_b near the critical threshold on the fixed jawarm 3, the resistance between the second electrode 332 and the first electrode 431 and the resistance between the second electrode 333 and the first electrode 432 are all equal to or less than the first threshold, and both the second electrodes 332, 333 satisfy the condition i of the second electrode S_b for determining the critical threshold. When the second electrode 332 is regarded as S_b, S_b+1 is the second electrode 333, the resistance between the second electrode 333 and the first electrode 432 is equal to or less than the first threshold, the condition iii) of the second electrode S_b that does not satisfy the above-described judgment threshold is satisfied, and when the second electrode 333 is regarded as S_b, S_b+1 is the second electrode 334, the resistance between the second electrode 334 and the first electrode 433 is greater than the first threshold, the condition iii) of the second electrode S_b that satisfies the above-described judgment threshold is satisfied. Therefore, the second electrode 333 that satisfies both the conditions i) and iii) of the second electrode S_b for determining the critical threshold is determined as the second electrode S_b for determining the critical threshold. After the second electrodes 331 and 333 of the two critical thresholds are determined, the second electrodes 331, 332, 333 and the first electrodes 431, 432 are selected as working electrodes. At this time, since b is 3, which is smaller than the total number of the second electrodes n+1 (6) on the fixed jaw arm, in order to further optimize the ablation effect, the relationship between the resistance between the second electrode 333 and the first electrode 433 and the first threshold value is further compared, and the resistance between the second electrode 333 and the first electrode 433 is equal to or smaller than the first threshold value, the first electrode 433 is also selected as the working electrode. Fig. 12 shows only one case where the target ablation tissue covers part of the first electrode and the second electrode, i.e. the target ablation tissue covers part of the electrode near the distal end of the jaw portion, the present specification details how the second electrode of the critical threshold is determined and how the working electrode is selected. In other cases, for example, the target ablation tissue covers only the first electrode and the second electrode at the middle portion of the jaw portion, the edge of the target ablation tissue does not cover the first electrode and the second electrode 331 on the fixed jaw arm 3, or the target ablation tissue covers only a portion of the electrode near the proximal end of the jaw portion, which can be judged and selected by those skilled in the art according to the above-mentioned judgment conditions, and details are not repeated here.

When there is only one first electrode on the movable jawarm 4 and the fixed jawarm 3 includes a plurality of second electrodes, the first impedance between the first electrode and each second electrode is detected, each first impedance is compared with a first threshold value, and all the second electrodes and the first electrodes with the first impedance smaller than the first threshold value are selected as working electrodes.

In the control method of the present invention, the first threshold is set to distinguish between the completely empty electrode (i.e. the non-working electrode) and the electrode holding the target ablation tissue (i.e. the working electrode), and the specific impedance value between the working electrodes may have different results according to the different states of the target ablation tissue, and the person skilled in the art may set different first thresholds according to the target ablation tissue, preferably, the first threshold is 500 ohms. The impedance detection module 230 is configured with a dielectric constant detection unit, which outputs an excitation signal (e.g., a sine wave constant current source with a peak value of 10 uA) containing a voltage signal to the first electrode and the second electrode to be detected, respectively, and the excitation signal generates a voltage after acting on the target ablation tissue. The acquired voltage is processed according to the following expression 1, and the resistance between the two electrodes can be obtained.

The formula 1: y=ks+b,

Wherein Y is the acquisition voltage;

s is a resistor to be measured;

K. B is a coefficient.

The central control module 260 sends the results of the selected working electrodes to the interactive control module 250 for display, which may be displayed in a manner commonly used in the art, for example, different colors may be used to label the working electrodes and the non-working electrodes.

Further, in performing ablation, if the target ablated tissue is not in good contact with the electrode, there is a risk of short circuiting. Therefore, it is necessary to pre-examine the degree of contact between the target ablated tissue and the electrode before performing the main pulse ablation. The control method of the invention comprises an S2 working electrode pre-inspection step, and the aim is achieved by controlling relevant components of the pulse ablation forceps 100 and the pulse ablation instrument 200. Specifically, the impedance detection module 230 detects a second impedance between two adjacent electrodes on the same side jawarms and feeds back to the central control module 260. The central control module 260 compares a second resistance between the j-th electrode and the j+1-th electrode on the same-side jawarm to a second threshold to determine whether the electrodes meet the discharge criteria. When the second resistance is less than the second threshold, the central control module 260 issues an instruction to the pulse generation module 240 to cause the pulse generation module 240 to inhibit electrode discharge in such a manner that j+1th electrode discharge is inhibited when j is greater than or equal to n/2, and j < n/2 th electrode discharge is inhibited. In the present invention, the second threshold is preferably 350 ohms. Likewise, the impedance between two adjacent electrodes may be detected using methods known in the art, for example by the dielectric constant detection unit described above. In a preferred embodiment, the central control module 260 sends the comparison of the impedance between adjacent electrodes to the second threshold to the interactive control module 250 for display to facilitate corresponding adjustment of the ablation forceps by the operator. If the adhesion is found to be unstable, the impedance between the connected electrodes can be adjusted to be within a second threshold range by adjusting the clamping angle of the ablation forceps, wiping and replacing the ablation forceps, and the like. Specifically, S1 and S2 may be repeated, or S2 may be repeated only, as the case may be, after adjusting the clamping angle of the ablation forceps or wiping the replacement ablation forceps.

After the selection and pre-detection of the working electrode are completed, the discharge control step S3 is performed, and the central control module 260 instructs the pulse generation module 240 to cause the pulse generation module 240 to transmit a pulse signal to the working electrode. The manner in which the working electrodes form electrode pairs and the manner in which the discharge is performed may be as in any of fig. 9-16, 19-29, and the details of which are described in the preceding section of the present invention are not repeated here. In a preferred embodiment, the kth first electrode forms an electrode pair with the kth second electrode and the kth+1th second electrode respectively, and the pulse generating module 240 sends pulse signals to one or more of the electrode pairs respectively according to the instruction of the central control module 260, so that the first electrode in the electrode pair is one of positive and negative electrodes, and the second electrode in the electrode pair is the other electrode in the positive and negative electrodes, wherein k is equal to or greater than 1 and n. By discharging the first electrode and the second electrode to form an electrode pair, an ablation notch (O in fig. 6) of the target ablation tissue located at the intermediate portion of the first electrode and the second electrode can be reduced or eliminated.

In a preferred embodiment, step S3 further comprises a discharge protection control, wherein the generated pulse signal is converted into a current signal, the current signal is compared with a third threshold value, and if the current signal is greater than the third threshold value, the pulse output is terminated. Fig. 33 is an example diagram of a gate-controlled overcurrent protection circuit implemented by hardware. As shown in fig. 33, the gate-controlled overcurrent protection circuit comprises a pulse generation control unit U1, transformers TR1 and TR2, a threshold value unit VG1, and a threshold value comparison output unit OP1, wherein N1 and N2 respectively represent primary and secondary windings of the transformers. Wherein the pulse signal generated by the pulse generation control unit U1 is used as the input excitation of a subsequent circuit. Transformers TR1, TR2 are used to achieve coupling and electrical isolation of the circuit signals. The threshold unit VG1 provides the circuit with a current signal of a third threshold value for comparison with the excitation signal coupled via the transformer TR2. The threshold comparison output unit OP1 has two inputs connected to the threshold unit VG1, to which the third threshold is set, and to one output connected to the transformer TR1, respectively. The threshold comparison output unit OP1 is operative to compare the signal obtained by the transformer TR2 with the signal supplied from the threshold unit VG1, and to output a corresponding level signal according to the comparison result for determining whether the signal obtained by the transformer TR2 meets or exceeds a set third threshold. If the third threshold value is exceeded, the threshold value comparison output unit OP1 outputs a feedback signal, which is sent to the pulse generation control unit U1 via the transformer TR1, terminating the pulse output.

In another preferred embodiment, step S3 further includes collecting the ablation current values in real time during the ablation process, so as to implement ablation energy calculation, implementing total current sampling during the ablation process by triggering AD sampling at a high speed, and implementing ablation energy derivation by an integration algorithm. As shown in fig. 34, the energy harvesting circuit specifically includes a pulse generation control unit U1, a transformer M1, a data processing unit U2, and a data buffering and filtering unit IOP1, where N1 and N2 represent primary and secondary windings of the transformer, respectively. In the working process, the pulse generation control unit U1 generates pulses, pulse signals reach a secondary side through the coupling of the transformer M1, the secondary side signals are transmitted to the data filtering and buffering unit IOP1, data processed by the IOP1 reach the data processing unit U2, the data processing unit U2 adopts triggered sampling to solve the data caching problem, the data processing unit monitors pulse current signals in real time, and integral operation is carried out on the pulse current signals according to the following formula 2, so that actual output energy is obtained. If the actual output energy is below or above the desired, adjustments may be made by increasing or decreasing the ablation voltage, etc., to ensure that the energy output meets the desired.

The formula 2:E =p = t=u x I x T,

Wherein E is ablation energy;

p is the ablation generated power;

t is the sampling interval time;

u is pulse voltage;

i is pulse current.

In a preferred embodiment of the present invention, before step S1, the method further includes a step S-1a pressure alert, in this embodiment, the pulse ablator 200 further includes a pressure detection module 220, where the pressure detection module 220 is configured to detect a pressure applied to the first electrode on the movable jawarm 4 and the second electrode on the fixed jawarm 3, and feed back the pressure to the central control module 260, and the central control module 260 compares the pressures applied to the first electrode and the second electrode, and feeds back the result to the interactive control module 250 for display. The pressure experienced by each electrode on each of the two jawarms is collected by a pressure sensor on each jawarm, after which the pressure sensor sends the pressure to the pressure sensing module 220. In a preferred embodiment, the central control module 260 compares whether the difference between the pressures received by the first and second electrodes is less than or equal to 5% and feeds back the result to the interactive control module 250 in such a manner that the (n+1)/2 th second electrode on the fixed jaw arm 3, the (n+3)/2 th second electrode, and the (n+1)/2 nd first electrode on the movable jaw arm 4 are respectively compared when n is an odd number, and the n/2 th second electrode on the fixed jaw arm 3, the (n/2) +1 th second electrode, and the n/2 th first electrode on the movable jaw arm 4 are respectively compared when n is an even number. The interactive control module 250 displays the comparison result. Through the above operation, the clamping condition of the pulse ablation forceps 100 on the target ablation tissue can be preliminarily judged. When the difference of the electrode pressures at the middle parts of the two side forceps arms is less than or equal to 5%, the electrode pressures on the two side forceps arms are judged to be similar, and the target ablation tissue is well clamped between the two forceps arms of the pulse ablation forceps 100. If the pressure difference between the electrodes on the two forceps arms does not meet the requirement, the pressure difference can be adjusted by changing the clamping angle of the ablation forceps and the like, and the step S-1a is repeated until the pressure difference is less than or equal to 5%.

In a preferred embodiment, before step S-1a, step S-1 b) of identifying control is further included, in which embodiment, the pulse ablation forceps 100 includes an identification module, the identification module includes parameter information of the pulse ablation forceps 100, the pulse ablation instrument 200 includes a host identification module 210, and the host identification module 210 is connected to the central control module 260, and identifies the identification module according to an instruction of the central control module 260 to acquire the parameter information of the pulse ablation forceps 100.

In summary, the pulse ablation forceps and the pulse ablation instrument system provided by the invention have the advantages that the plurality of second electrodes are arranged on the fixed forceps arms, at least one part of the electrodes close to the chute is arranged in the chute, the target ablation tissue entering the chute can be ablated, the leakage of ablation is avoided, and meanwhile, the first electrodes on the movable forceps arms are arranged outside the chute, and the phenomena of electric arc, short circuit and the like caused by too close distance between the first electrodes and the second electrodes are avoided. In addition, because a certain distance exists between the segmented electrodes, and an ablation gap exists between the segmented electrodes in the ablation process, the invention can support the tissue to be ablated at the gap position through the insulating protrusions arranged between the adjacent electrodes of the forceps arms, so that the tissue to be ablated enters the range of the pulse electric field, thereby compensating the ablation gap and avoiding ablation leakage. In addition, the control method of the invention avoids the occurrence of short circuit and other conditions caused by the fact that the target ablation tissue is not clamped between the electrodes or the bonding degree of the electrodes and the target ablation tissue is not high through the selection of the working electrode and the control of the pre-detection. Meanwhile, the control method of the invention avoids the leakage ablation of target ablation tissues at the middle positions of the two side forceps arms by controlling the electrode cross discharge on the two side forceps arms.

While the embodiments of the present invention have been described in detail with reference to the drawings, the present invention is not limited to the above embodiments, and various components of the present invention may be used in any combination, and various changes may be made without departing from the spirit of the present invention within the knowledge of those skilled in the art.

Claims (10)

1.A pulse ablation system is characterized by comprising a pulse ablation clamp and a pulse ablation instrument connected with the pulse ablation clamp, wherein,

The pulse ablation forceps comprise a forceps body and a jaw part which is arranged on the forceps body and consists of a fixed forceps arm and a movable forceps arm parallel to the fixed forceps arm, the jaw part is used for realizing the purpose of clamping or releasing target ablation tissues through the movement of the movable forceps arm relative to the fixed forceps arm, the forceps body comprises a chute, the fixed forceps arm is fixedly connected to the far end of the chute, and the movable forceps arm is close to or far away from the fixed forceps arm along the chute, and the pulse ablation forceps is characterized in that n first electrodes are arranged on the movable forceps arm from the far end to the near end along the extending direction of the jaw part, n+1 second electrodes are arranged on the fixed forceps arm, and n is more than or equal to 2; the projection of each first electrode on the fixed clamp arm is positioned between two second electrodes in the direction perpendicular to the extending direction of the fixed clamp arm, all the first electrodes are arranged outside the sliding groove, and at least one part of the (n+1) th second electrode is arranged inside the sliding groove;

the pulse ablation instrument comprises a pulse generation module, a central control module and an interaction control module, wherein at least one of the pulse ablation clamp and the pulse ablation instrument comprises an impedance detection module;

the impedance detection module is used for detecting first impedance between the first electrode on the movable clamp arm and the second electrode on the fixed clamp arm, and detecting second impedance between two adjacent electrodes on the same side clamp arm, and feeding back to the central control module;

The pulse generation module is used for generating and sending pulse signals to each of the first electrode and the second electrode independently under the control of the central control module;

The central control module is connected with the impedance detection module, the pulse generation module and the interaction control module and is used for receiving information of other modules for processing and feeding back and/or displaying the processed information;

the interaction control module is used for displaying information and receiving control instructions of a user.

2. The pulse ablation system of claim 1, wherein the impedance detection module detects a first impedance between n of the first electrodes on the movable clamp arm and n+1 of the second electrodes on the fixed clamp arm, respectively, by a resistance between an mth of the first electrodes on the movable clamp arm and an mth of the second electrodes on the fixed clamp arm, and by a resistance between an mth of the first electrodes on the movable clamp arm and an mth of the +1 of the second electrodes on the fixed clamp arm, 1≤m≤n.

3. The pulsed ablation system of claim 2, said central control module comparing said first impedance detected by said impedance detection module to a first threshold to select a working electrode, wherein,

First determining a second electrode S_a and a second electrode S_b of critical thresholds at two ends of the fixed clamp arm, wherein the second electrode S_a and the second electrode S_b meet the following conditions that i) the resistance between the second electrode S_a and the first electrode M_a and the resistance between the second electrode S_b and the first electrode M_b-1 are all smaller than or equal to the first threshold, wherein 1≤a≤b≤n+1, ii) the second electrode S_a-1 does not exist, or when the second electrode S_a-1 exists, the resistance between the second electrode S_a-1 and the first electrode M_a-1 is larger than the first threshold, and iii) the second electrode S_b+1 does not exist, or when the second electrode S_b+1 exists, the resistance between the second electrode S_b+1 and the first electrode M_b is larger than the first threshold;

Then, all the second electrodes among the second electrode S_a, the second electrode S_b, the second electrode S_a, and the second electrode S_b, the first electrode M_a, the first electrode M_b-1, and all the first electrodes among the first electrode M_a and the first electrode M_b-1 are used as working electrodes.

4. The pulsed ablation system of claim 3, wherein the pulse ablation system comprises,

Further comparing whether the resistance between the second electrode S_a and the first electrode M_a-1 is equal to or less than the first threshold value when a >1, and using the first electrode M_a-1 as a working electrode when the resistance between the second electrode S_a and the first electrode M_a-1 is equal to or less than the first threshold value;

When b < n+1, further comparing whether the resistance between the second electrode S_b and the first electrode M_b is equal to or less than the first threshold value, and when the resistance between the second electrode S_b and the first electrode M_b is equal to or less than the first threshold value, the first electrode M_b is also used as a working electrode.

5. The pulse ablation system of claim 1, wherein the central control module compares the second resistance between the j-th electrode and the j+1-th electrode on the ipsilateral clamp arm to a second threshold value, and when the second resistance is less than the second threshold value, the central control module instructs the pulse generation module to inhibit electrode discharge by:

and when j is larger than or equal to n/2, the j+1th electrode is forbidden to discharge, and when j is smaller than n/2, the j electrode is forbidden to discharge.

6. The pulse ablation system according to claim 5, wherein a kth one of the first electrodes forms an electrode pair with a kth one of the second electrodes and a kth +1th one of the second electrodes, respectively, and the pulse generation module sends pulse signals to one or more of the electrode pairs, respectively, according to the instruction of the central control module, such that the first electrode in the electrode pair is one of positive/negative electrodes and the second electrode in the electrode pair is the other of positive/negative electrodes, wherein k is 1≤k≤n.

7. The pulse ablation system of claim 5, further comprising a pressure detection module for detecting a pressure experienced by the first electrode on the movable jawarm and the second electrode on the fixed jawarm and feeding back to the central control module.

8. The pulsed ablation system of claim 7, wherein the central control module compares whether the pressure difference experienced by the first electrode and the second electrode is less than or equal to 5% and feeds back the results to the interactive control module:

When n is an odd number, respectively comparing the pressure applied to the (n+1)/2 th second electrode, the (n+3)/2 nd second electrode and the (n+1)/2 nd first electrode on the movable clamp arm;

When n is an even number, the pressure applied by the n/2 th second electrode, the (n/2) +1 th second electrode and the n/2 th first electrode on the movable clamp arm are respectively compared.

9. The pulse ablation system of any of claims 1-8, wherein the pulse ablation forceps comprise an identification module containing parameter information of the pulse ablation forceps, the pulse ablation instrument comprises a host identification module connected to the central control module for identifying the identification module according to instructions of the central control module to obtain the parameter information of the pulse ablation forceps.

10. A control method for the pulsed ablation system of any of claims 1-9, the method comprising:

The method comprises the steps of S1) selecting a working electrode, wherein the central control module sends an instruction to the impedance detection module, the impedance detection module detects first impedance between the first electrode on the movable clamp arm and the second electrode on the fixed clamp arm and feeds the first impedance back to the central control module, and the central control module compares the first impedance with the first threshold value to determine the working electrode;

s2) working electrode pre-detection, wherein the central control module sends an instruction to the impedance detection module, the impedance detection module detects second impedance between two adjacent working electrodes on the same side clamp arm and feeds the second impedance back to the central control module, and the central control module compares the second impedance with the second threshold value to determine whether the working electrodes meet a discharge standard or not;

S3) discharging control, wherein the central control module sends an instruction to the pulse generation module, and the pulse generation module sends a pulse signal to the working electrode.