CN115399865A

CN115399865A - Ablation electrode needle, ablation system and machining process of ablation electrode needle

Info

Publication number: CN115399865A
Application number: CN202211359327.9A
Authority: CN
Inventors: 衷兴华; 马剑豪; 刘红梅
Original assignee: Hangzhou Vena Anke Medical Technology Co ltd
Current assignee: Hangzhou Vena Anke Medical Technology Co ltd
Priority date: 2022-11-02
Filing date: 2022-11-02
Publication date: 2022-11-29

Abstract

The invention discloses an ablation electrode needle, an ablation system and a processing technology of the ablation electrode needle, and relates to the technical field of high-end equipment manufacturing. According to the technical scheme, the ablation electrode needle is provided with the two coaxial electrodes, so that the ablation electrode needle is suitable for the position of lesion in a dense blood vessel or a narrow space, and is quick and convenient to perform operation.

Description

Ablation electrode needle, ablation system and machining process of ablation electrode needle

Technical Field

The invention relates to the technical field of high-end equipment manufacturing, in particular to an ablation electrode needle, an ablation system and a machining process of the ablation electrode needle.

Background

The traditional clinical treatment of tumors generally comprises chemotherapy, radiotherapy, surgical resection and the like, the traditional treatment has the defects of large side effect on human bodies, large wound area and the like, and the latest technical treatment is irreversible electroporation which is mainly characterized by minimally invasive ablation.

Irreversible electroporation (IRE) therapy is a therapy in which a set of high-voltage electrical pulses is sent through electrodes to create an electric field in the tissue that causes irreversible electroporation of the cell membrane, thereby causing apoptosis of the tumor cells. Irreversible electroporation has become an emerging technique for non-thermal treatment of tumors and other non-cancerous pathologies. This solution delivers a series of short and strong electrical pulses through electrodes implanted directly or placed around the diseased tissue, creating an electric field between the electrodes, altering the transmembrane potential of the cell membrane, which, once it reaches a threshold, causes electroporation of the cell, which, as the electric field continues to increase, causes irreversible electroporation of the cell, causing apoptosis of the cell. Meanwhile, because the steep pulse has extremely short acting time (microsecond level), the generated thermal effect is usually negligible, and no thermal injury is generated to tissues.

In the prior art, when the operation ablation is carried out, two to six single-pole ablation needles are generally punctured simultaneously according to the size of a tumor, high-voltage pulses are applied between the two single-pole ablation needles respectively for tumor ablation, and the requirement on parallelism between the two single-pole ablation needles is higher during discharge ablation, so that the operation difficulty of a doctor is higher. Irreversible electroporation ablation is a mode of tumor ablation therapy, which often requires multiple paired ablation needles that simultaneously penetrate the tumor and electroporate the tumor by electrical discharge between the two needles. Due to the arrangement of a plurality of ablation needles, the problem of difficult needle arrangement often exists for the lesion position of dense blood vessels or in narrow space.

Disclosure of Invention

The invention mainly aims to provide an ablation electrode needle, which is suitable for a lesion position in a dense blood vessel or a narrow space and enables the operation to be simpler and quicker.

In order to achieve the above object, the present invention provides an ablation electrode needle, including:

the electrode comprises a first electrode needle and a second electrode needle tube, wherein the second electrode needle tube is coaxially sleeved on the first electrode needle; and the combination of (a) and (b),

the first insulating layer is coaxially sleeved between the first electrode needle and the second electrode needle tube, and the second insulating layer is coaxially sleeved on the second electrode needle tube;

the partial structure of the first electrode needle extends out of the first insulating layer along the axial direction of the ablation electrode needle to form a first electrode part, the partial structure of the second electrode needle tube extends out of the second insulating layer along the axial direction of the ablation electrode needle to form a second electrode part, and the part, exposed out of the second electrode needle tube, of the first insulating layer is an insulating part.

In an embodiment of the present invention, a length of the first electrode portion and a length of the second electrode portion are equal.

In an embodiment of the present invention, a length ratio of the first electrode portion to the insulating portion ranges from 1 to 1.

In an embodiment of the invention, the length range of the insulating part is 5 to 20 mm.

In an embodiment of the invention, the outer diameters of the first electrode part and the second electrode part are 0.3 to 1.5 mm.

In an embodiment of the present invention, the material of the first electrode needle and the second electrode needle tube is stainless steel.

In an embodiment of the invention, the tip end of the first electrode needle is located at the intersection of the periphery of the first electrode needle and the end point.

In an embodiment of the present invention, a material of the first insulating layer and the second insulating layer is at least one of polyetheretherketone, zirconia, alumina, or polyimide.

In an embodiment of the invention, the ablation electrode needle further comprises a handle, the handle comprises two detachably connected parts, and the two parts of the handle clamp and fix the first electrode needle and the second electrode needle tube.

In an embodiment of the invention, the ablation electrode needle further comprises a first electrical connector and a second electrical connector, the first electrical connector is electrically connected with one end of the first electrode needle far away from the first electrode part through a first conductive cable, the second electrical connector is electrically connected with one end of the second electrode needle far away from the second electrode part through a second conductive cable, and one end of the first conductive cable and one end of the second conductive cable are mounted on the handle.

The present invention also proposes an ablation system comprising:

an ablation electrode needle as described above; and (c) and (d),

the host computer is provided with a pulse current module, the host computer is electrically connected with the ablation electrode needle and conducts pulse current, and the ablation electrode needle is used for forming an electric field on a tissue to be ablated through the first electrode part and the second electrode part so as to ablate the tissue to be ablated.

The invention also provides a processing technology of the ablation electrode needle, which comprises the following steps:

pretreatment of an ablation electrode needle: scrubbing the surfaces of the stainless steel needle and the stainless steel needle tube and soaking the stainless steel needle tube in alcohol to obtain a first stainless steel needle and a second stainless steel needle tube;

preparing a first electrode needle: preparing a first insulating layer on the surface of the processed first stainless steel needle, wherein the first electrode needle partially extends out of the first insulating layer to form a first electrode part, so as to obtain a first electrode needle;

preparing a second electrode needle tube: preparing a second insulating layer on the surface of the processed second stainless steel needle tube, wherein the second electrode needle tube part extends out of the second insulating layer to form a second electrode part, so that a second electrode needle tube is obtained;

assembling an ablation electrode needle core: coaxially sleeving a second electrode needle tube on a first electrode needle, wherein a first insulating layer on the first electrode needle extends out of the second electrode needle tube to form an insulating part, so that an ablation electrode needle core is obtained;

welding an electric connector: welding one end of a first conductive cable at one end of the first electrode needle far away from the first electrode part to obtain a first electrode needle connection part, welding one end of a second conductive cable at one end of the second electrode needle far away from the second electrode part to obtain a second electrode needle connection part, and respectively connecting the other ends of the first conductive cable and the second conductive cable with a first electric connector and a second electric connector to obtain a first connection wire and a second connection wire;

assembling an ablation electrode needle: and assembling the upper and lower shells and the internal fixing block of the handle on the ablation electrode needle core, and installing the first electrode needle connecting part and the second electrode needle connecting part on the handle to obtain the ablation electrode needle.

In an embodiment of the present invention, in the processes for preparing the first electrode needle and the second electrode needle, one or more of chemical bonding, thermal spraying, chemical vapor deposition and the like may be used as a preparation process, and the preparation processes used for the first insulating layer and the second insulating layer may be the same or different.

According to the technical scheme, the ablation electrode needle is formed by coaxially sleeving the first electrode needle, the second electrode needle tube, the first insulating layer and the second insulating layer, part of the structure of the first electrode needle axially extends out of the first insulating layer along the ablation electrode needle to form the first electrode part, part of the structure of the second electrode needle tube axially extends out of the second insulating layer along the ablation electrode needle to form the second electrode part, and the part of the first insulating layer exposed out of the second electrode needle tube is the insulating part.

Drawings

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

FIG. 1 is a schematic structural view of an embodiment of an ablation electrode needle of the present invention;

FIG. 2 is a schematic cross-sectional view of the ablation electrode needle of FIG. 1;

FIG. 3 is an enlarged view of a portion of FIG. 2 at A;

fig. 4 is a diagram of the ablation effect when the ratio of the lengths of the first electrode part and the insulating part of the ablation electrode needle in fig. 1 is 1;

FIG. 5 is a graph of the ablation effect of the ablation electrode needle of FIG. 1 with a ratio of the length of the first electrode portion to the length of the insulating portion of 1;

FIG. 6 is a graph of the ablation effect of the ablation electrode needle of FIG. 1 with a ratio of the lengths of the first electrode portion and the insulating portion of 1;

FIG. 7 is a graph of the ablation effect of the ablation electrode needle of FIG. 1 with a ratio of the length of the first electrode portion to the length of the insulating portion of 1;

fig. 8 is a diagram showing the ablation effect when the ratio of the lengths of the first electrode part and the insulating part of the ablation electrode needle in fig. 1 is 1.

The reference numbers illustrate:

1. an ablation electrode needle; 10. a first electrode needle; 100. a first electrode section; 11. a first insulating layer; 110. an insulating section; 12. a second electrode needle tube; 120. a second electrode section; 13. a second insulating layer; 14. a first electrical connector; 140. a first electrically conductive cable; 15. a second electrical connector; 150. a second electrically conductive cable; 20. a handle; 21. an upper shell; 22. a lower shell.

The implementation, functional features and advantages of the present invention will be further described with reference to the accompanying drawings.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the present invention, unless otherwise expressly stated or limited, the terms "connected," "secured," and the like are to be construed broadly, and for example, "secured" may be a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In addition, descriptions such as "first", "second", etc. in the present invention are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

The electrocoagulation method widely used in surgery in the ablation electrode technology is monopolar electrocoagulation, in which a metal plate with a large area is contacted with a patient to serve as a return electrode, which is generally called a patient electrode or a non-effective electrode, and another electrode is connected with a hemostatic instrument to perform the electrocoagulation function, which is called a surgical electrode or an effective electrode. The monopolar electrocoagulation is used to connect with various surgical instruments, the electrode forms an electric field to act on tissues to achieve the purposes of hemostasis or cutting and the like, the monopolar electrocoagulation requires large electric energy and generates wide heat diffusion range, the electrode arranged on the body of a patient can generate heat, and the damage to adjacent tissues is also large. Therefore, the ablation electrode is not suitable for being used in important parts such as a functional area of a cortex, the vicinity of an important blood vessel, a brain stem, a spinal cord, nerve roots and other special areas.

Therefore, in order to reduce the damage of the surrounding tissues and ensure the effect of the operation, the energy of the working electrode must be more intensively released. Irreversible electroporation ablation is utilized not to have a heat effect but to have a biological effect of electric energy, irreversible electroporation technology adopts pulse current to supply energy, the pulse current in one moment avoids heating tissues, small-area damage to surrounding tissues can be accurately realized, and the range boundary of irreversible electroporation ablation is only the width of a few layers of cells, so that the treatment range is more precise and controllable compared with the traditional heat energy ablation technology. Irreversible electroporation can also maintain the organizational structure during ablation, but the operation mode among the prior art is to use two electrode needles to ablate, and keeps two electrode needles to maintain parallel state, and the operation degree of difficulty is very big, and to the pathological change position in intensive blood vessel or narrow space, it is also very difficult to carry out the cloth needle of a plurality of quantity.

In order to solve the above problems, the present invention provides an ablation electrode needle 1. Referring to fig. 1 to fig. 3, the ablation electrode needle 1 includes a first electrode needle 10 and a second electrode needle tube 12, and the second electrode needle tube 12 is coaxially sleeved on the first electrode needle 10; the electrode needle comprises a first electrode needle 10, a second electrode needle 12, a first insulating layer 11, a second insulating layer 13 and a third insulating layer 13, wherein the first insulating layer 11 is coaxially sleeved between the first electrode needle 10 and the second electrode needle 12, and the second insulating layer 13 is coaxially sleeved on the second electrode needle 12. Wherein, a part of the structure of the first electrode needle 10 extends out of the first insulating layer 11 along the axial direction of the ablation electrode needle 1 to form a first electrode part 100, a part of the structure of the second electrode needle tube 12 extends out of the second insulating layer 13 along the axial direction of the ablation electrode needle 1 to form a second electrode part 120, and the part of the first insulating layer 11 exposed out of the second electrode needle tube 12 is an insulating part 110.

Irreversible electroporation operation needs two electrodes, and ablation electrode needle 1 sets up first electrode needle 10 and second electrode needle tubing 12 on single electrode needle and regards as two electrodes respectively, does not need many electrode needles just to realize the operation, has reduced doctor's cloth needle degree of difficulty, and easy operation is convenient, is applicable to the focus in narrow space and has the important organs of heart and brain of intensive blood vessel. In the irreversible electroporation operation, in order to make the discharge energy uniform, two electrodes need to be arranged in parallel, the second electrode needle tube 12 is coaxially sleeved on the first electrode needle 10 so that the two electrodes are positioned on the same central axis and keep parallel, the diameters of the first electrode needle 10 and the second electrode needle tube 12 are kept consistent along the length direction, and meanwhile, in order to avoid the short circuit caused by the direct contact of the first electrode needle 10 and the second electrode needle tube 12, a first insulating layer 11 is coated between the first electrode needle 10 and the second electrode needle tube 12. In the irreversible electroporation process, the size of the ablation range and the strength of the electric field need to be accurately controlled, an electrode part needs to be arranged on the first electrode needle 10 and the second electrode needle tube 12 for performing the discharge ablation operation, the part of the first insulating layer 11 not covering the first electrode needle 10 is a first electrode part 100, similarly, the second insulating layer 13 covers the second electrode needle tube 12, and the part of the second electrode needle tube 12 not covered by the second insulating layer 13 is a second electrode part 120.

The material of the first electrode needle 10 and the second electrode needle 12 is stainless steel, and in this embodiment, stainless steel is used. The stainless steel has high strength, excellent corrosion resistance and conductivity, when irreversible electroporation is performed, the stainless steel needle part of the ablation electrode needle 1 can easily puncture the tissue surface to enter the inside for operation, and the materials of the first electrode needle 10 and the second electrode needle 12 can also be metal materials with corrosion resistance and wire performance, which is not limited in the invention. The material of the first insulating layer 11 and the second insulating layer 13 is at least one of polyetheretherketone, zirconia, alumina, or polyimide. The materials have excellent corrosion resistance and insulation performance, high stability, difficult reaction with human tissues, no influence of body fluid and human secretion, and extremely high peeling resistance, can be made into an extremely thin coating layer, is extremely firmly combined with the first electrode needle 10 and the second electrode needle tube 12 which are made of stainless steel materials, is difficult to fall off, and also prevents relative sliding between the first electrode needle 10 and the second electrode needle tube 12.

In one embodiment, the first electrode needle 10 has a solid structure without any lumen or opening. In another embodiment, the first electrode needle 10 has a lumen structure, or the first electrode portion 100 having a lumen structure has one or more openings on the tube wall, the structure of the lumen and the opening has a smaller contact area when puncturing the ablated tissue, so that the contact pressure is increased, the openings on the tube wall adjust the internal and external pressures, and a smaller force can also be used for puncturing, so that the fineness of the irreversible electroporation operation is improved, and the first electrode needle can also be used for delivering substances, such as suspensions containing one or more therapeutic agents and diagnostic agents, hydrogels, colloidal suspensions containing nano-particles and micro-particles, so as to increase the electrical conductivity of the tissue and increase the ablation efficiency. In other embodiments, the substance is released to alter the conductivity of the tissue. In other embodiments, the device is capable of extracting a substance selected from the group consisting of a tissue, a fluid, a medium, a solution, a suspension, a therapeutic agent, a hydrogel, a nanoparticle, and a microparticle.

In order to make it easier to pierce the surface of the ablation group, the front end of the first electrode needle 10 is further provided with a bevel structure forming a tip, and the lumen provided by the tip is also easier to deliver the therapeutic agent or other substances into the tissue. The tip is arranged on a single inclined plane, a bullet type or an egg type structure with the diameter gradually reduced can be further arranged on the first electrode needle 10 with the solid structure, the tip is located on the central axis of the ablation electrode needle 1, the power line is very dense due to the large curvature of the tip, the potential gradient is also enlarged, after the ablation electrode needle 1 is electrified by pulse current, the electric charges of the tip are very dense, the electric field intensity generated in the moment can be improved, the tissue ablation effect is better, and the treatment effect is improved.

However, in some embodiments of the irreversible electroporation process, the body organs with important physiological functions are not easy to use the electrode part at the tip for the irreversible electroporation process, such as the inner parietal lobe of the brain, occipital lobe, temporal lobe, frontal lobe, brain stem, cerebellum, duct, gland, the part with dense ventricular nerves, or the adipose tissue, breast tissue and lymphatic tissue which need to maintain the physiological steady state, the electric field at the tip is too high and the puncture effect is provided, so that the body tissues are easy to damage. The blunt first electrode needle 10 has a distinct advantage in that the blunt first electrode needle 10 can be used in an area where tissue is weak or easily damaged by other devices used in the art, and the blunt first electrode needle 10 is more accurate and precise in operation since the blunt tip itself has a non-cutting structure without being able to pierce surrounding structures. The tissue to be ablated remains intact and minimally affected, with minimal collateral damage, providing greater freedom of movement for the operator. In some embodiments, the blunt first electrode needle 10 may contact, even provide pressure to, change the shape of, or move a tissue structure or surrounding structure by applying non-cutting and non-piercing pressure that does not pierce a tissue or organ membrane. And does not produce holes, tears or perforations, thereby maintaining the maximum physiological integrity of the tissue.

Referring to fig. 3, in the irreversible electroporation, the two electrodes need to maintain the same current intensity to maintain the stability of the electric field and avoid further damage to the ablated tissue, the two electrodes are both powered by the same pulse current, the portion of the first electrode needle 10 exposed outside the first insulating layer 11 is the first electrode portion 100, and the portion of the second electrode needle 12 exposed outside the second insulating layer 13 is the second electrode portion 120, so the length of the first electrode portion 100 is equal to the length of the second electrode portion 120. Under the condition that the thickness of the insulating layer is small, the lengths of the first electrode part 100 and the second electrode part 120 are equal, the areas of the first electrode part 100 and the second electrode part 120 are similar to the same, the electric field intensity generated by the first electrode part 100 and the second electrode part 120 is uniform everywhere, the abnormal local discharge is avoided, the ablation area of the tissue to be ablated is better controlled, in addition, under the condition of facing different cases, the ablation electrode needle 1 can generate different electric field intensities only by changing the lengths of the electrode parts, and the application scenes are various.

When the lengths of the first electrode part 100 and the second electrode part 120 are equal, the length ratio of the first electrode part 100 to the insulating part 110 ranges from 1 to 1. For example, the axial distance between the first electrode portion 100 and the second electrode portion 120 represented by the length of the insulating portion 110 may be 1. In the case of using a pulse current, as the distance between the first electrode part 100 and the second electrode part 120 increases, the radiation area of the generated electric field increases and tends to be uniform, the resistance to current flow starts to decrease, the voltage also tends to decrease, the ablation effect also decreases, and the inter-electrode distance continues to increase, the smaller the distance between the first electrode part 100 and the second electrode part 120, the better the ablation effect, but the smaller the ablation area also correspondingly decreases, so in order to increase the ablation area, the distance between the positive electrode and the negative electrode can be increased, and the pulse voltage can be increased at the same time. When the length ratio of the first electrode part 100 to the insulating part 110 is lower than 1, the axial distance between the first electrode part 100 and the second electrode part 120 is already smaller than the length of the first electrode part 100, the generated discharge range is too small, the ablation area is too small, effective ablation operation on a tissue to be ablated cannot be performed, multiple operations are required, the difficulty of irreversible electroporation operation is increased, and the operation success rate is reduced, when the length ratio of the first electrode part 100 to the insulating part 110 is higher than 1.

The first insulating layer 11 and the second insulating layer 13 both coat most of the first electrode needle 10 and the second electrode needle tube 12 along the length direction of the ablation electrode needle 1, the first insulating layer 11 is located between the first electrode needle 10 and the second electrode needle tube 12 and plays a role in insulating and combining the first electrode needle 10 and the second electrode needle tube 12, part of the first insulating layer 11 is exposed outside the second electrode needle tube 12 to form an insulating part 110, and the length range of the insulating part 110 is 5-20 mm. For example, the length of the insulating portion 110 is less than 1.5 mm, the surface area of the insulating portion 110 is too small, the axial distance between the first electrode portion 100 and the second electrode portion 120 is too small, the insulating effect of the insulating portion 110 on the first electrode portion 100 and the second electrode portion 120 is weakened or even disappeared, abnormal discharge or short circuit between the first electrode portion 100 and the second electrode portion 120 is likely to occur, and single-point electric shock injury occurs on the tissue to be ablated, when the length of the insulating portion 110 is greater than 3 mm, the surface area of the insulating portion 110 is too large, the axial distance between the first electrode portion 100 and the second electrode portion 120 is too large, the insulating effect of the insulating portion 110 on the first electrode portion 100 and the second electrode portion 120 is too large, the first electrode portion 100 and the second electrode portion 120 cannot induce an electric field, and the tissue to be ablated cannot be subjected to irreversible electroporation.

Referring to fig. 4 to 8, fig. 4 is a graph of ablation effect when the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is 1, the lengths of the first electrode portion 100 and the second electrode portion 120 are 5 mm, and the length of the insulating portion 110 is 5 mm; fig. 5 is a graph of ablation effect when the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is 1; fig. 7 is a graph of ablation effect when the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is 1; fig. 8 is a graph of ablation effect when the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is 1. The above tissues to be ablated all achieve excellent ablation effect when irreversible electroporation operation is carried out, the ablation edge is clear, the first electrode part 100 and the second electrode part 120 are arranged in parallel, the electric field intensity generated by the first electrode part 100 and the second electrode part 120 is uniform, the range and the ablation intensity are well controlled, and the ablation range is increased along with the increase of the distance between the first electrode part 100 and the second electrode part 120. Fig. 6 is a graph of ablation effect when the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is 1. In fig. 4, compared with fig. 6, although the length of the first electrode portion 100 in fig. 6 is smaller, the ratio of the lengths of the first electrode portion 100 and the insulating portion 110 is larger, so that the ablation area of the tissue to be ablated in fig. 4 and 6 is substantially the same when the lengths of the insulating portions 110 are equal.

Preferably, when the length ratio of the first electrode part 100 to the insulating part 110 is 1.

When the site for performing irreversible electroporation is usually a site with a dense blood vessel and a complex structure, such as a brain, a cardiovascular site, and the like, an ablation electrode needle 1 with a fine size is required for operation, a second electrode needle tube 12 is coaxially sleeved on a first electrode needle 10, the outer diameter of the second electrode needle tube 12 is larger than the outer diameter of the first electrode needle 10, and the outer diameters of a first electrode part 100 and a second electrode part 120 are 0.3 to 1.5 mm. For example, the outer diameter of the first electrode portion 100 may be 0.3 mm, 0.8 mm, or 1.3 mm, the outer diameter of the second electrode portion 120 may be 0.5 mm, 1 mm, or 1.5 mm, when the outer diameters of the first electrode portion 100 and the second electrode portion 120 are less than 0.3 mm, the strength of the first electrode portion 100 and the second electrode portion 120 may be reduced, bending may easily occur in the tissue to be ablated, and irreversible electroporation cannot be performed, and when the outer diameters of the first electrode portion 100 and the second electrode portion 120 are greater than 1.5 mm, an excessively large outer diameter of the electrode portion may not perform irreversible electroporation on the tissue to be ablated having a complicated structure, and may even damage other peripheral tissues.

Referring to fig. 2 again, the ablation electrode needle 1 further includes a handle 20, and the handle 20 includes two detachably connected parts, which are respectively an upper shell 21 and a lower shell 22 for holding and fixing the first electrode needle 10 and the second electrode needle 12 on the two parts of the handle 20. First electrode needle 10 and second electrode needle tubing 12 extend to suitable operation length, and for avoiding operating personnel directly to touch the needle tubing body that melts electrode needle 1 in the irreversible electroporation operation, detachable handle 20 is regarded as the operation position about setting up, improves the simple operation nature, and handle 20 chooses for use plastics etc. to have insulating and high strength's material, and upper and lower part adopts screw assembly or sets up the joint structure and carries out the components of a whole that can function independently and combine. The handle 20 is installed at a position where the first electrode needle 10 is far away from the first electrode part 100, a sufficient discharge area and a needle body are reserved for operation, irreversible electroporation operation with a longer distance is facilitated, a plurality of fixing posts are arranged inside the handle 20, and the first electrode needle 10 and the second electrode needle 12 are fixed at multiple positions on two sides, so that stability is improved.

The ablation electrode needle 1 further comprises a first electrical connector 14 and a second electrical connector 15, the first electrical connector 14 is electrically connected to an end of the first electrode needle 10 away from the first electrode part 100 through a first conductive cable 140, the second electrical connector 15 is electrically connected to an end of the second electrode needle tube 12 away from the second electrode part 120 through a second conductive cable 150, and an end of the first conductive cable 140 and an end of the second conductive cable 150 are mounted on the handle 20. The part of the first electrode needle 10 connected with the first conductive cable 140 is arranged to extend out of the second electrode needle tube 12 and the first insulating layer 11, the part of the second electrode needle tube 12 connected with the second conductive cable 150 is arranged to extend out of the second insulating layer 13, the joint of the first electrode needle 10 and the first conductive cable 140 and the joint of the second electrode needle tube 12 and the second conductive cable 150 are both positioned inside the handle 20, and the first conductive cable 140 and the second conductive cable 150 extend out of the handle 20. The handle 20 is a full-sealed structure, the first electrode needle 10 and the second electrode needle tube 12 block the front end opening, the first conductive cable 140 and the second conductive cable 150 block the rear end opening, and external foreign matters and water are prevented from entering the joint to cause damage to internal devices.

The present invention also proposes an ablation system comprising: the specific structure of the ablation electrode needle 1 refers to the above embodiments, and since the system adopts all technical solutions of all the above embodiments, at least all the beneficial effects brought by the technical solutions of the above embodiments are achieved, and no further description is given here. The main machine is provided with a pulse current module, the main machine is electrically connected with the ablation electrode needle 1 and conducts pulse current, and the ablation electrode needle 1 is used for forming an electric field on a tissue to be ablated through the first electrode part 100 and the second electrode part 120 so as to ablate the tissue to be ablated. The main machine is provided with two electric sockets for connecting the first electric connector 14 and the second electric connector 15, the intensity of the pulse current released by the pulse current module in the main machine can be adjusted, and the ablation area and the ablation effect of the ablation electrode needle 1 can be adjusted by controlling the intensity of the pulse current.

The invention also provides a processing technology of the ablation electrode needle 1, which comprises the following steps:

pretreatment of an ablation electrode needle 1: scrubbing the surfaces of the stainless steel needle and the stainless steel needle tube and soaking the stainless steel needle tube in alcohol to obtain a first stainless steel needle and a second stainless steel needle tube;

preparing the first electrode needle 10: preparing a first insulating layer 11 on the surface of the processed first stainless steel needle, wherein the first electrode needle 10 partially extends out of the first insulating layer 11 to form a first electrode part 100, and thus obtaining a first electrode needle 10;

preparing the second-electrode needle tube 12: preparing a second insulating layer 13 on the surface of the processed second stainless steel needle tube, wherein the second electrode needle tube 12 partially extends out of the second insulating layer 13 to form a second electrode part 120, so as to obtain a second electrode needle tube 12;

assembling an ablation electrode needle core: coaxially sleeving a second electrode needle tube 12 on a first electrode needle 10, wherein the first insulating layer 11 on the first electrode needle 10 partially extends out of the second electrode needle tube 12 to form an insulating part 110, so as to obtain an ablation electrode needle core;

welding an electric joint: welding one end of a first conductive cable 140 to one end of the first electrode needle 10, which is far away from the first electrode part 100, to obtain an electricity connection part of the first electrode needle 10, welding one end of a second conductive cable 150 to one end of the second electrode needle tube 12, which is far away from the second electrode part 120, to obtain an electricity connection part of the second electrode needle tube 12, and respectively connecting the other ends of the first conductive cable 140 and the second conductive cable 150 with two electric connectors to obtain a first electricity connection head 14 and a second electricity connection head 15;

assembling an ablation electrode needle 1: the upper and lower cases and the internal fixing blocks of the handle 20 are assembled on the core of the ablation electrode needle 1, and the electric connection part of the first electrode needle 10 and the electric connection part of the second electrode needle tube 12 are installed on the handle 20, thus obtaining the ablation electrode needle 1.

In the processes of preparing the first electrode needle 10 and the second electrode needle 12, one or more of chemical bonding, thermal spraying, chemical vapor deposition, and the like may be used as the preparation process, and the processes used for the first insulating layer 11 and the second insulating layer 13 may be the same or different. The electrode needle and the insulating layer are fixed by the adhesive, the cost is low, the use efficiency is high, the thermal spraying is based on the thermoplastic characteristics of materials such as polyether-ether-ketone and polyimide, the first insulating layer 11 and the second insulating layer 13 which are subjected to thermal spraying treatment can reach thinner thickness, the ablation effect of the ablation electrode needle 1 can be further improved, the chemical vapor deposition mainly aims at firm coatings such as aluminum oxide and zirconium oxide which have excellent insulating properties but are stable in shape, and the insulating layer formed by the chemical vapor deposition mode is thinner, firmer and not easy to damage.

The above description is only an alternative embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention, which are made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. An ablation electrode needle, comprising:

the electrode comprises a first electrode needle and a second electrode needle tube, wherein the second electrode needle tube is coaxially sleeved on the first electrode needle; and (c) and (d),

the partial structure of the first electrode needle extends out of the first insulating layer along the axial direction of the ablation electrode needle to form a first electrode part, the partial structure of the second electrode needle tube extends out of the second insulating layer along the axial direction of the ablation electrode needle to form a second electrode part, and the part, exposed outside the second electrode needle tube, of the first insulating layer is an insulating part.

2. The ablation electrode needle according to claim 1, wherein a length of the first electrode portion and a length of the second electrode portion are equal.

3. The ablation electrode needle according to claim 2, wherein the length ratio of the first electrode part to the insulating part is in a range from 1 to 1.

4. The ablation electrode needle according to claim 3, wherein the length of the insulating part is in a range of 5 to 20 mm.

5. The ablation electrode needle according to claim 2, wherein the outer diameters of the first electrode part and the second electrode part are 0.3 to 1.5 mm.

6. The ablation electrode needle of claim 1, wherein the material of the first electrode needle and the second electrode needle tube is stainless steel.

7. The ablation electrode needle of claim 1, wherein the tip of the first electrode needle is located at an intersection of the first electrode needle circumference and the tip.

8. The ablation electrode needle of claim 1, wherein a material of the first insulating layer and the second insulating layer is at least one of polyetheretherketone, zirconia, alumina, or polyimide.

9. The ablation electrode needle of claim 1, further comprising a handle, wherein the handle comprises two detachably connected parts, and the two parts of the handle hold the first electrode needle and the second electrode needle tube.

10. The ablation electrode needle of claim 9 further comprising a first electrical connector electrically connected to an end of the first electrode needle distal from the first electrode portion by a first electrically conductive cable and a second electrical connector electrically connected to an end of the second electrode needle distal from the second electrode portion by a second electrically conductive cable, an end of the first electrically conductive cable and an end of the second electrically conductive cable being mounted to the handle.

11. An ablation system, comprising:

the ablation electrode needle according to any one of claims 1 to 10; and the combination of (a) and (b),

12. A machining process of an ablation electrode needle is characterized by comprising the following steps:

welding an electric connector: welding one end of a first conductive cable at one end of a first electrode needle far away from a first electrode part to obtain a first electrode needle connection part, welding one end of a second conductive cable at one end of a second electrode needle far away from a second electrode part to obtain a second electrode needle connection part, and respectively connecting the other ends of the first conductive cable and the second conductive cable with a first electric connector and a second electric connector to obtain a first connection wire and a second connection wire;

assembling an ablation electrode needle: assembling the upper and lower shells of the handle and the internal fixing block on the ablation electrode needle core, and installing the first electrode needle connecting part and the second electrode needle connecting part on the handle to obtain the ablation electrode needle.

13. The process for manufacturing an ablation electrode needle according to claim 12, wherein in the process for manufacturing the first electrode needle and the second electrode needle tube, one or more of chemical bonding, thermal spraying, chemical vapor deposition and the like can be used, and the first insulating layer and the second insulating layer can be manufactured by the same or different processes.