CN211934275U

CN211934275U - Double-electrode electrotome device

Info

Publication number: CN211934275U
Application number: CN201922115474.1U
Authority: CN
Inventors: 徐宏; 尤玲丽; 周乐; 黄元新
Original assignee: Hangzhou Kunbo Biotechnology Co Ltd
Current assignee: Hangzhou Kunbo Biotechnology Co Ltd
Priority date: 2019-11-29
Filing date: 2019-11-29
Publication date: 2020-11-17
Anticipated expiration: 2029-11-29

Abstract

The application discloses a double-electrode electrotome device, which comprises a sheath tube, a handle connected to the near end of the sheath tube and a first electrode connected to the far end of the sheath tube, wherein the first electrode is of a cylindrical structure, the axial far end side of the first electrode is a cutting working part, and the axial near end side of the first electrode is a connecting part fixed with the sheath tube; the double-electrode electrotome device further comprises a second electrode arranged at an interval with the first electrode, the second electrode is positioned at the proximal end side of the first electrode, and the second electrode is cylindrical and is sleeved and fixed on the periphery of the sheath tube; and a first lead connected with the first electrode and a second lead connected with the second electrode are embedded in the tube wall of the sheath tube. The technical scheme disclosed by the application has the advantages of accurate positioning in the treatment process, various treatment means, controllable treatment process, good treatment effect and difficult recurrence.

Description

Double-electrode electrotome device

Technical Field

The application relates to the field of medical equipment, in particular to a double-electrode electrotome device.

Background

At present, lung diseases, especially Chronic Obstructive Pulmonary Disease (COPD), bullous lung (pulmonary bulla) and the like, have great influence on human productive life. Wherein Chronic Obstructive Pulmonary Disease (COPD) includes chronic bronchitis and emphysema. COPD is often characterized by airflow obstruction, particularly limiting the ventilation of the patient during exhalation. Patients with chronic bronchitis have chronic cough with sputum production resulting in respiratory obstruction. In patients with emphysema, destruction of the lung parenchyma may lead to loss of elastic recoil, reduced airway range, obstruction of exhalation, and coughing. The pulmonary bulla (pulmonary bulla) refers to the air sac-containing cavity formed in the lung tissue by the pressure rise in the alveolar cavity caused by various reasons and the rupture and fusion of the alveolar walls.

Surgery is a common option in clinical treatment, but if the diseased part of the lung is removed by surgery, the surgery usually results in a reduction of the effective lung amount of about 15-30%, which may not be sufficient to cause a significant increase in lung function. Meanwhile, lung cancer patients with older age, weak constitution, poor heart and lung functions or complications are not suitable for or tolerant to conventional surgical resection therapy.

Therefore, minimally invasive surgery gradually enters the visual field of people, such as a plurality of local treatment methods of tumor minimally invasive ablation and the like. The tumor minimally invasive Ablation of the lung comprises Radio Frequency Ablation (RFA), cryoablation, microwave Ablation and the like, wherein only the Radio Frequency Ablation is listed by the non-small cell lung cancer clinical guidance of the United states national comprehensive cancer network.

The principle of the radio frequency ablation is that alternating high-frequency current with the frequency less than 30MHz (generally 460-480 kHz) is applied to enable ions in tumor tissues to generate high-speed oscillation and mutual friction, radio frequency energy is converted into heat energy, and therefore coagulative necrosis of tumor cells occurs. In radiofrequency ablation therapy, the device used is an electrotome, the distal electrode of which is capable of transmitting radiofrequency energy to the tissue surrounding the site of penetration after percutaneous penetration. When the radiofrequency ablation therapy is carried out, the electrode of the electrotome is connected with the radiofrequency generator, and under the guidance of B-ultrasonic or CT, the percutaneous puncture is carried out and the target tumor is punctured through a puncture point. The neutral electrode is also connected to a radio frequency generator, which is attached to the appropriate part of the patient's body. When the foot switch on the radio frequency generator is stepped on, a loop is established between the electrode of the electrotome and the neutral electrode and communicated with each other, and high-frequency current acts on the human tissue between the electrode of the electrotome and the neutral electrode, so that tumor cells contacted with the electrode at the far end of the electrotome are coagulated, denatured and necrotized.

The inventor finds that when the existing electric knife for the lung works, the existing radio frequency ablation operation cannot effectively judge the accurate position of the front end electrode of the radio frequency ablation catheter even under the guidance of B ultrasonic or CT. The CT images are a limited number of cross-sectional images obtained by X-ray scanning, and at some angles, it appears that the front electrode is placed at the target region, but the actual position may not be correct, and only the front electrode is overlapped in the projection direction, so that the position of the front electrode is difficult to determine, and the positioning accuracy is insufficient.

Meanwhile, because the treatment means is relatively single, the existing treatment means has the problem that after the blocked part is opened, the focus area is blocked again after the operation, and the treatment effect is poor.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem, the application discloses a double-electrode electric knife device, which comprises a sheath tube, a handle connected to the proximal end of the sheath tube and a first electrode connected to the distal end of the sheath tube, wherein the first electrode is of a cylindrical structure, the axial distal side of the first electrode is a cutting working part, and the axial proximal side of the first electrode is a connecting part fixed with the sheath tube;

the double-electrode electrotome device further comprises a second electrode arranged at an interval with the first electrode, the second electrode is positioned at the proximal end side of the first electrode, and the second electrode is cylindrical and is sleeved and fixed on the periphery of the sheath tube;

and a first lead connected with the first electrode and a second lead connected with the second electrode are embedded in the tube wall of the sheath tube.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the distal side and/or the proximal side of the second electrode is further provided with a heat insulation ring fixed on the outer periphery of the sheath.

Optionally, the axial length of the heat insulation ring is 0.5-2 mm.

Optionally, the axial length of the second electrode is 5-12 mm.

Optionally, the ratio of the axial length of the second electrode to the axial length of the first electrode is 5/6-2.

Optionally, the distance between the second electrode and the first electrode in the axial direction is 0.5-4 mm.

Optionally, the distal end side of the first lead is welded and fixed to the inner wall of the first electrode;

the distal end side of the second lead is welded and fixed to the inner wall of the second electrode.

Optionally, the first and second wires are arranged on opposite sides of the sheath axis.

Optionally, a second connection terminal is mounted on the handle, and a proximal end of the second wire is electrically connected to the second connection terminal.

Optionally, a second switch for controlling the second lead circuit to be switched on and off is arranged on the proximal end side of the sheath, and the second switch is directly arranged on the handle or fixed on the sheath.

Optionally, the electrotome device further comprises an anchor head and an anchor core connected to the anchor head, the anchor core defines a threading path in a use state, and the sheath is slidably sleeved on the anchor core and can move to the distal end along the threading path.

Optionally, the distal side of the anchor head is tapered to form a tip.

Optionally, at least a portion of the anchor head is a working portion made of a conductive material, and a third wire electrically connected to the working portion is inserted into the anchor core.

The application realizes multiple functions through double electrodes, such as double-position ablation, ablation and then coagulation elimination, for example, electric ablation and then coagulation elimination, and the like. The design of the double electrodes can facilitate the implementation of the treatment processes such as ablation, coagulation removal, electrotomy and the like, and the applied and disclosed technical scheme has the advantages of accurate positioning in the treatment process, various treatment means, controllable treatment process, good treatment effect and difficult recurrence.

Specific advantageous technical effects will be further explained in the detailed description in combination with specific structures.

Drawings

FIG. 1 is a schematic view of an embodiment of an electrotome device;

FIG. 2 is a schematic cross-sectional view of the electrotome device of FIG. 1;

FIG. 3 is a schematic view of the internal structure of the electrotome device of FIG. 1;

FIG. 4a is a schematic view of the first electrode and sheath of FIG. 1;

FIG. 4b is a perspective view of the first electrode and the sheath of FIG. 1;

FIG. 5 is a schematic view of the first electrode shown in FIG. 1;

FIG. 6 is a schematic view of an embodiment of an electrotome device;

FIG. 7 is a schematic cross-sectional view of the electrotome device of FIG. 6;

FIG. 8 is a schematic view of the first and second electrodes of FIG. 6;

FIG. 9 is a schematic view of the first electrode, the second electrode and the sheath of FIG. 6;

FIG. 10a is a schematic view of an embodiment of an electrotome device;

FIG. 10b is a schematic view of the anchor core and anchor head of FIG. 10;

FIG. 11a is a schematic view of the sheath tube of FIG. 10 advanced along the anchor core;

FIG. 11b is a schematic view of the sheath tube of FIG. 10 retracted along the anchor core;

fig. 12 is a schematic view of the internal structure of the anchor head of fig. 10.

The reference numerals in the figures are illustrated as follows:

11. a sheath tube; 111. a first conductive line; 1111. a first lead distal end; 1112. a first wire jacket; 1113. A first wire through hole; 112. a second conductive line; 1121. a second lead distal end; 113. a third conductive line;

12. a handle; 121. a first connection terminal;

13. a first electrode; 131. a cutting work part; 132. a connecting portion; 1321. a through hole;

14. a pipe joint; 15. a second electrode; 151. a heat insulating ring; 161. a first switch; 162. a second switch; 17. an anchor head; 171. a cylindrical section; 172. a conical section; 173. a first mounting groove; 174. a second mounting groove;

18. an anchoring core; 181. an anchor head control handle; 182. and a third connecting terminal.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, 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 application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 to 2, an embodiment of the present application discloses an electric knife device, which includes a sheath 11, a handle 12 connected to a proximal end of the sheath 11, and a first electrode 13 connected to a distal end of the sheath 11, wherein the first electrode 13 is a cylindrical structure, a distal end side of the first electrode 13 in an axial direction is a cutting working portion 131, and a proximal end side of the first electrode 13 in the axial direction is a connecting portion 132 fixed to the sheath 11.

The electrotome device sends the first electrode 13 into a human body through the sheath tube 11 and is close to a target tissue, and a series of treatment processes such as cutting, ablation, electrocoagulation and the like of the target tissue are realized by releasing radio frequency energy to the target tissue through the first electrode 13. In the present embodiment, the first electrode 13 is preferably a cylindrical structure, and similar to the common structure of the sheath 11, it is convenient to provide a connecting portion 132 at the axial proximal end of the first electrode 13, so as to achieve a stable connection with the sheath 11. The cutting blade 131 on the axially distal side of the first electrode 13 is used to directly make electrical contact with the target tissue, thereby releasing the radio frequency energy for functionality. The cylindrical structure of the first electrode 13 can provide a plurality of functions for the cutting work part 131. For example, when used in a therapeutic procedure such as cutting, the cutting work part 131 may approach the target tissue through the bottom surface of the cylindrical structure, and a relatively thin sidewall is used to form a relatively small contact area for facilitating cutting; when used in ablation or the like, the cutting work portion 131 can be brought close to the target tissue through the circumferential surface of the cylindrical structure, thereby forming a large contact area. Thereby realizing the treatment process of first electrocision and then electrocoagulation and reducing the possibility of recurrence of the focus. In the specific operation, firstly, the electric excision can be selected to form a through channel, the vacuum suction is carried out by negative pressure to take the cut tissue, and then the electric coagulation and the scabbing are carried out, so that the technical effect of avoiding the secondary blockage of the postoperative healing is realized.

In one embodiment, the proximal end of the sheath 11 extends through and is fixed to the handle 12, and the portion of the sheath 11 extending out of the handle 12 is provided with a connector 14 for connecting an external device.

In a practical and complicated treatment process, at different treatment stages, the electrotome device often needs to be connected with various external devices to realize different treatment functions. Therefore, the design of the pipe joint 14 can facilitate the access of external equipment, reduce the workload of medical workers and other operators, and lead the operators and the like to be more concentrated on the treatment process, thereby improving the experience.

The design of the pipe joint 14 is various, and can be adjusted according to different use scenarios and requirements, and a more general interface in the art, such as a luer joint, can be adopted to improve the versatility.

Referring to fig. 1 to 5, in an embodiment, the electric knife device includes a sheath 11, a handle 12 connected to a proximal end of the sheath 11, and a first electrode 13 connected to a distal end of the sheath 11, the first electrode 13 is a cylindrical structure, a distal end side of the first electrode 13 in an axial direction is a cutting working portion 131, a proximal end side of the first electrode 13 in the axial direction is a connecting portion 132 fixed to the sheath 11, wherein the cutting working portion 131 of the first electrode 13 is a circumferential closed structure.

The circumferential closed structure means that a path which is connected end to end and surrounds the outer circumferential surface of the first electrode 13 for one circle exists, large-area hollowing does not exist on the outer circumferential surface of the first electrode 13, and the design can provide good mechanical strength for the first electrode 13 and avoid accidents such as damage, falling parts and the like in a human body; and the tissue in the human body is not easy to generate blocking interference with the first electrode 13, thereby being convenient for the operator to use. In a specific design, the circumferential enclosing structure can be adjusted as required, for example, opening holes avoiding certain solid bodies, etc., so that the circumferential enclosing structure is not completely enclosed in an absolute sense, but only needs to satisfy line contact for cutting the target tissue and surface contact for ablation and electrocoagulation in certain embodiments. Of course, in some embodiments, the cutting blade 131 of the first electrode 13 is completely closed in the circumferential direction, i.e., does not have any cut-out.

The shape of the end of the cutting work part 131 may be adjusted as desired according to various lesions and conditions, and in one embodiment, the end of the cutting work part 131 is a flat head or a pointed head.

The end of the cutting work portion 131 is a portion that directly contacts the target tissue. Generally, during a treatment process such as cutting, the end of the cutting working part 131 is a part directly acting on the target tissue, and when the shape of the end of the cutting working part 131 is changed, some additional technical advantages are brought, for example, when the end of the cutting working part 131 is a pointed end, a smaller contact area with the target tissue can be provided, and a smaller volume of target prevention can be conveniently treated. The different technical advantages of the different structures are also the reason for choosing different structures as desired.

When the end part of the cutting working part 131 is a flat head, the cutting working part 131 realizes the cutting of the target tissue through the side wall of the cylindrical structure by combining the first electrode 13 as the cylindrical structure; when the cutting blade 131 is pointed at the end (not shown), the cutting blade 131 can cut the target tissue through the tip of the pointed tip.

The axial length of the cutting work portion 131 determines two indexes, i.e., the maximum depth at which the first electrode 13 can cut the target tissue and the maximum contact area with the target tissue. These two indicators directly influence the progress of the treatment and the effect of the treatment. In one embodiment, the axial length of the cutting work portion 131 of the first electrode 13 is 4-6 mm.

When the length of the cutting working part 131 of the first electrode 13 is too short, the cutting depth is small, and when the target tissue is thick, the operation is inconvenient; when the length of the cutting operation part 131 of the first electrode 13 is too long, it is not favorable for the interventional procedure, and the long first electrode 13 is inconvenient to advance in the human body. Therefore, the axial length of the cutting work portion 131 of the first electrode 13 is preferably 4 to 6 mm.

Compared with the flexibility of the sheath 11, the first electrode 13 is rigid and is not easy to bend in the human body, so that the total length of the first electrode 13 in the axial direction is required to facilitate the implementation of the interventional procedure. The length ratio of the cutting work portion 131 and the connecting portion 132 needs to be adjusted. The actual working process of the electric knife device is realized by the cutting working part 131, so that from the functional point of view, the longer the cutting working part 131 is, the more parts are available; however, the first electrode 13 is fixed by the connection portion 132, the first electrode 13 inserted into the human body is subjected to external forces such as extrusion and pulling of human tissues, the connection of components fails due to the absence of stable connection, the treatment process is terminated if the connection is not stable, and new problems are caused if components are left in the human body if the connection is heavy, so that the cutting operation portion 131 and the connection portion 132 both have certain requirements on length. In one embodiment, the ratio of the axial lengths of the cutting working portion 131 and the connecting portion 132 of the first electrode 13 is 1: 0.3-3.

In different scenes, the ratio of the axial length of the cutting work part 131 to the axial length of the connecting part 132 is 1: 0.3-3. Accordingly, when the length of the connection portion 132 becomes short, a corresponding structure or technical means needs to be designed to secure the connection effect.

In some preferred embodiments, the ratio of the axial length of the cutting work part 131 to the axial length of the connecting part 132 of the first electrode 13 is 1: 0.5-2.

The first electrode 13 is always kept together with the sheath 11 during use of the electrotome device, and therefore there is no separate requirement for use. The sheath 11 is typically a plastic material, and the first electrode 13 may be integrally formed with the sheath 11 during the manufacturing process. In one embodiment, the connecting portion 132 of the first electrode 13 has a hollow area, and a part or all of the hollow area is embedded and fixed in the tube wall of the sheath 11.

It should be noted that in the embodiment, the first electrode 13 is made of an electrically conductive material, and the sheath 11 is made of an insulating material, and the difference between the materials may cause a problem in the fit between the first electrode 13 and the sheath 11, especially in the process of temperature variation, the connection may fail due to the difference of the expansion coefficients of the first electrode and the sheath. A secure connection between the components is very important in the field of interventions, since the detachment of the components has a great influence on the human body. The effect of fretwork area is with spacing change to realizing spacing through partly structure counterbalance through frictional force between two kinds of materials. In the present embodiment, the plastic material of the sheath 11 enters the hollow area during molding, and thus abuts against the boundary of the hollow area, so as to prevent the relative movement between the first electrode 13 and the sheath 11. On the premise of technical idea consistency, in some other embodiments, the form of the hollowed-out region may be deformed, for example, a part of the material of the first electrode 13 protrudes out of the outer peripheral surface of the first electrode, and the sheath 11 is formed to wrap the protrusion of the first electrode 13, so as to prevent the relative movement between the first electrode 13 and the sheath 11.

Since the first electrode 13 directly contacts with the human tissue in the interventional field, and may be twisted, adhered, pulled, etc., the first electrode 13 needs to be able to maintain a stable connection with the sheath 11 under stress in various directions, in one embodiment, the hollow area includes a plurality of through holes 1321, and each through hole 1321 is distributed along the circumference of the first electrode 13.

The circumferentially arranged through-hole 1321 can circumferentially restrict the relative movement of the first electrode 13 and the sheath 11. This design is very important in the interventional field, and therefore the circumferential arrangement of the through holes 1321 can greatly improve the connection strength of the first electrode 13 with the sheath 11.

In one embodiment, the through holes 1321 are divided into two to four groups, the groups are sequentially arranged along the axial direction of the first electrode 13, and the through holes 1321 of the same group are distributed along the circumferential direction of the first electrode 13.

The through holes 1321 are distributed with a plurality of groups to form an array-type hollow area on the outer peripheral surface of the connecting part 132 of the first electrode 13, so that the connecting strength between the sheath tube 11 and the first electrode 13 can be effectively improved, and the stability of the electrotome device is improved. When the first electrode 13 is subjected to a force, the through-hole 1321 located at different positions in the axial direction of the first electrode 13 is not necessarily subjected to uniform stress. For example, when the first electrode 13 is subjected to a pulling force or a pushing force along the axial direction thereof, the stress direction of each through hole 1321 is along the circumferential direction of the first electrode 13; when the first electrode 13 is subjected to a torsional stress, the through holes 1321 in different arrangements are subjected to stresses with different directions and different magnitudes.

In one embodiment, the through holes 1321 between adjacent sets are aligned with each other in the circumferential direction of the first electrode 13. Each through hole 1321 in fact acts as a fixing point, so that in fact more fixing points are provided at the through holes 1321 arranged in alignment with each other, which contributes to increasing the stability of the first electrode 13 in the axial direction thereof, which is more resistant to stresses in this direction.

In other embodiments, the through holes 1321 between adjacent groups are arranged offset in the circumferential direction of the first electrode 13. The offset arrangement of the through holes 1321 enables a denser fixation point for a given number of through holes 1321, so that the first electrode 13 can be selected as desired for different situations.

In one embodiment, the number of vias 1321 in the same set is 1, 2, 3, 4, 5, or 6.

The increase in the number of the through holes 1321 can bring about a more stable connection effect, but the through holes 1321 have an influence on the structural strength of the first electrode 13 itself when provided. Therefore, in actual production, it is necessary to control the total area of the through holes 1321, the structural strength of the first electrode 13 cannot be reduced by opening the through holes 1321, the number of the through holes 1321 is inversely related to the sectional area of the individual through holes 1321 as a whole, and the sectional area of each through hole 1321 is not greatly different.

In one embodiment, each of the through holes 1321 has the same shape, and for one of the through holes 1321, the inner edge thereof is polygonal or the inner edge thereof is a smooth curve. Of course, the shape of each through-hole 1321 may be different in other embodiments.

The sectional shape of the through-hole 1321 also affects the connection effect of the connection portion 132. For example, when the cross-sectional shape of the through hole 1321 is a shape having a sharp included angle, a stress concentration portion is likely to occur at the included angle, and the sheath 11 and the through hole 1321 may generate a mutual cutting effect at this time, which may cause a connection failure, and needs to be overcome by increasing the number of the through holes 1321 and optimizing the arrangement position. Therefore, the shape of each through-hole 1321 is preferably polygonal or the inner edge is smoothly curved

In one embodiment, some or all of the vias 1321 are rectangular.

For example, when the cross-sectional shape of the through hole 1321 is rectangular, the axial and circumferential acting areas of the first electrode 13 of the offset part of the sheath 11 and the single through hole 1321 are large, the connection stability is improved, more importantly, the structure which is convenient to produce in the production process is easy to control the precision, the through hole 1321 with the rectangular cross section can effectively reduce the production cost, and the design considers the connection effectiveness and the production process requirement.

In one embodiment, a first lead 111 is embedded in the wall of the sheath 11, a proximal end of the first lead 111 extends to the handle 12, and a distal end 1111 of the first lead is electrically connected to the first electrode 13.

The first lead 111 functions to establish an electrical connection between the rf source and the first electrode 13 for delivering rf energy to the first electrode 13. The first wire 111 is embedded in the sheath 11 and passes through the human body following the sheath 11. Generally, first lead 111 and sheath 11 are fixedly connected, i.e. cannot be displaced relatively, and this design is mainly realized by molding first lead 111 and sheath 11 as an integral structure during the production process. The sheath 11 can provide protection for the first wire 111, and prevent foreign substances such as gas, liquid, and solid from affecting the function of the first wire 111. The first conductive wire 111 may be a composite structure with an outer layer made of insulating material and an inner layer made of conductive material, or may be made of a single conductive material, because the sheath 11 itself can provide shielding and protection for the first conductive wire 111. In this embodiment, the sheath 11 is provided with a first lead through hole 1113 for the first lead 111 to pass through, and the first lead 11 passes through the first lead sheath 1112 and is disposed in the first lead through hole 1113. The first lead sheath 1112 and the sheath 11 together protect the first lead 111.

The first conducting wire 111 needs to be electrically connected to the first electrode 13 to realize the function of the electrotome device, so that the first conducting wire 111 can be fixed on the first electrode 13 by various structures, for example, a clamping component for clamping the first conducting wire 111 is arranged on the first electrode 13.

In one embodiment, the distal end 1111 of the first wire is welded to the inner wall of the first electrode 13.

In the embodiment, the welding refers to stable electrical connection, and specifically, there are various implementation forms, for example, electrical connection and physical fixation are achieved through a third-party welding medium; and electrically connected and physically fixed, for example, by partial melting of the conductive material of the first lead 111 or the first electrode 13. This connection fixing mode needs to satisfy three conditions: a stable electrical connection capable of delivering radio frequency energy to the first electrode 13; the two higher strength physical connections need not be easily defeated by an external force applied to the first electrode 13; the inertia of the material is also considered because the material inertia is high, the material cannot react with other substances, the position is exposed to the internal environment of the human body when in the human body, and if various metal materials exist at the welding position, the electrochemical reaction is easy to generate by adding current and a humid environment.

In the using process of the electrotome device, various using modes are possible according to different conditions of a focus, so that the electrotome device adopts a modularized design and can be flexibly combined to realize functions under different conditions. In one embodiment, a first terminal 121 is mounted on the handle 12, and the proximal end of the first wire 111 is electrically connected to the first terminal 121.

The first connection terminal 121 can provide a standard interface for the first electrode 13, which is convenient for the production and use of the corollary equipment.

In the actual treatment process of the electrotome device, a plurality of stages exist, and the working state of each part in each stage can generate difference. For example, when the first electrode 13 is not close to the target tissue, the first electrode 13 is in a standby state, and radio frequency energy is not released so as to avoid causing damage to normal tissues; it is desirable to begin to release rf energy when the first electrode 13 is in place. In one embodiment, a first switch 161 (as shown in fig. 6) for controlling the on/off of the first conducting wire 111 is disposed at the proximal end of the sheath 11, and the first switch 161 is directly disposed on the handle 12 or fixed on the sheath 11.

First switch 161 can the operating condition of accurate control first electrode 13, makes things convenient for operating personnel such as medical personnel to operate. However, in some cases, the first switch 161 cannot be provided on the handle 12 or fixed to the sheath 11. For example, in the technical solution shown in fig. 1, the first switch 161 is not shown, and in reality, the first switch 161 may be disposed on an external device or other parts due to various situations, such as device differences, focus differences, and surgical needs. The second switch 162 is the same hereinafter.

Referring to fig. 6 to 9, in an embodiment, the electric knife device includes a sheath 11, a handle 12 connected to a proximal end of the sheath 11, and a first electrode 13 connected to a distal end of the sheath 11, wherein the first electrode 13 has a cylindrical structure, a distal end side of the first electrode 13 in an axial direction is a cutting working portion 131, and a proximal end side of the first electrode 13 in the axial direction is a connecting portion 132 fixed to the sheath 11; the electrotome device further comprises a second electrode 15 arranged spaced apart from the first electrode 13, the second electrode 15 being on a proximal side of the first electrode 13.

The second electrode 15 can provide a richer functionality to the electrotome device. The advantage of this design is that the treatment process can be segmented for different requirements on the electrode shape, and the individual electrodes can be designed to better conform to the shape and characteristics of a particular treatment process. For example, the first electrode 13 is used for cutting, is designed to be a pointed small contact area, is long in length, facilitates the realization of cutting with larger depth, and the second electrode 15 is used for ablation, electrocoagulation and the like, is large in circumferential area, and facilitates the realization of large-area contact with the target tissue. The specific shape and characteristics of the first electrode 13 and the second electrode 15 can be adjusted as needed in the actual situation.

In order to avoid interference between the first electrode 13 and the second electrode 15, the spacing arrangement is a reasonable choice. The spacing arrangement specifically means that the first electrode 13 and the second electrode 15 are electrically insulated, and in terms of specific structure, the spacing arrangement has multiple implementation forms, for example, the first electrode 13 and the second electrode 15 are axially arranged in sequence, and a spacer ring for maintaining insulation is arranged in the middle; for another example, at least a portion of the first electrode 13 and the second electrode 15 are sleeved with each other, and the sleeved portion of the first electrode and the second electrode holds an isolation ring for keeping insulation; and so on.

In order to facilitate the insertion into the human body, the second electrode 15 has a design requirement for reducing the size of the entire device, so as to facilitate the operation. In one embodiment, the second electrode 15 is cylindrical and is fixed on the outer circumference of the sheath 11.

The sheath 11 is hollow cylindrical in general design, and the second electrode 15 is in order to realize the bigger area of contact with the target tissue, and the cover is the reasonable preferred in sheath 11 periphery, therefore the size of the whole device can effectively be reduced to the second electrode 15 of tube-shape, improves operating personnel's experience.

In actual selection, second electrode 15 can select to form partial fretwork on itself, conveniently realizes with the fixed of sheath 11, and the fretwork mainly acts on inside making things convenient for partial material entering second electrode 15 of sheath 11, realizes fixedly, improves joint strength.

In the case of the electrotome device performing a treatment, the first electrode 13 and the second electrode 15 may act for different treatment procedures and thus may have a time difference in operation, and in one embodiment, the distal side and/or the proximal side of the second electrode 15 is further provided with a heat insulating ring 151 fixed to the outer circumference of the sheath 11.

The thermal isolation ring 151 can eliminate the influence between the first electrode 13 and the second electrode 15, and the first electrode 13 and the second electrode 15 can be arranged more compactly, thereby facilitating the implementation and subsequent operation of the interventional procedure.

The axial length of the insulating ring 151 determines to some extent the gap between the first electrode 13 and the second electrode 15. In one embodiment, the axial length of the heat insulation ring 151 is 0.5-2 mm.

When the axial length of the heat insulation ring 151 is too small, the gap between the first electrode 13 and the second electrode 15 may be too small, and in a wet environment in a human body, the insulation may fail; when the axial length of the heat insulation ring 151 is too large, the distance between the first electrode 13 and the second electrode 15 is large, and the electrotome device is not convenient to operate when being inserted into a human body, particularly in the lung region, so that the axial length of the heat insulation ring 151 is preferably 0.5-2 mm

Compared with the flexibility of the sheath 11, the second electrode 15 is rigid and is not easy to bend in the human body, so that the total length of the second electrode 15 in the axial direction is required to facilitate the implementation of the interventional procedure. In one embodiment, the axial length of the second electrode 15 is 5-12 mm.

In principle, the distal end of the axial length of the second electrode 15 is more beneficial for the implementation of the interventional procedure, but the axial length of the second electrode 15 directly determines the contact area between the second electrode 15 and the target tissue, so the axial length of the second electrode 15 is preferably 5-12 mm under the consideration of the overall process and treatment effect of the interventional procedure.

The first electrode 13 and the second electrode 15 are both located at the side of the sheath 11 at the distal end, and the longer the axial length of the whole is, the more adverse to the implementation of the interventional procedure, but the axial length of the first electrode 13 and the second electrode 15 directly affects the direct contact area with the target tissue, so the axial length ratio of the first electrode 13 and the second electrode 15 needs to be designed, and in an embodiment, the ratio of the axial length of the second electrode 15 to the axial length of the first electrode 13 is 5/6-2.

Under the condition of ensuring the overall axial length of the two, the adjustment is carried out according to different lesion conditions. When the operation of the first electrode 13 is more important or a longer length is required, the length of the second electrode 15 can be shortened appropriately; when the operation of the second electrode 15 is more important or a longer length is required, the length of the first electrode 13 can be shortened appropriately, so as to achieve the technical purpose of improving the treatment effect without influencing the interventional process.

The axial distance between the second electrode 15 and the first electrode 13 directly affects the insulation performance of the second electrode 15 and the first electrode 13 and also affects the arrangement of the heat insulation ring 151, and in one embodiment, the axial distance between the second electrode 15 and the first electrode 13 is 0.5-4 mm.

If the distance is too small, insulation failure may occur in a humid environment in a human body; when the distance is too large, the electrotome device is not convenient to operate when the electrotome device intervenes in a human body, particularly in the lung region, so that the distance between the second electrode 15 and the first electrode 13 in the axial direction is preferably 0.5-4 mm.

In order to supply power to the first electrode 13 and the second electrode 15, respectively, in an embodiment, a first lead 111 and a second lead 112 are further embedded in the wall of the sheath 11;

the proximal end of the first lead 111 extends to the handle 12, and the distal end 1111 of the first lead is electrically connected to the first electrode 13;

the proximal end of the second wire 112 extends to the handle 12, and the distal end 1121 of the second wire is electrically connected to the second electrode 15.

The first lead 111 functions to establish an electrical connection between the rf source and the first electrode 13 for delivering rf energy to the first electrode 13. The second lead 112 functions to establish an electrical connection between the rf source and the second electrode 15 for delivering rf energy to the second electrode 15. The first and

second wires

111, 112 are embedded in the sheath 11, and the sheath 11 can pass through the human body along with the sheath 11 when moving. Generally, the first lead 111 and the second lead 112 are fixedly connected with the sheath 11, i.e. they cannot be displaced relatively, and this design is mainly realized by molding the first lead 111 and the second lead 112 with the sheath 11 as an integral structure during the production process. The sheath 11 can provide protection for the first and

second wires

111 and 112, and prevent foreign substances such as gas, liquid, and solid from affecting the functions of the first and

second wires

111 and 112. The first and

second wires

111 and 112 may be a composite structure with an outer layer made of insulating material and an inner layer made of conductive material, or may be made of a single conductive material, because the sheath 11 itself can provide shielding and protecting functions for the first and

second wires

111 and 112.

After the proximal ends of the first and

second wires

111 and 112 extend to the handle 12, corresponding electrical connectors can be disposed to facilitate connection with external circuits, and the form of the electrical connectors is not limited strictly, at least providing good circuit conduction and necessary connection strength.

In one embodiment, the distal end 1111 of the first wire is welded to the inner wall of the first electrode 13; the second distal lead end 1121 is welded and fixed to the inner wall of the second electrode 15.

In the embodiment, the welding refers to stable electrical connection, and specifically, there are various implementation forms, for example, electrical connection and physical fixation are achieved through a third-party welding medium; and electrically connected and physically fixed, for example, by partial melting of the conductive material of the first lead 111 or the first electrode 13. This connection fixing mode needs to satisfy three conditions: a stable electrical connection capable of delivering radio frequency energy to the first electrode 13 and the second electrode 15; the two physical connections with higher strength are required not to easily fail when the first electrode 13 and the second electrode 15 are subjected to external force; the inertia of the material is also considered because the material inertia is high, the material cannot react with other substances, the position is exposed to the internal environment of the human body when in the human body, and if various metal materials exist at the welding position, the electrochemical reaction is easy to generate by adding current and a humid environment.

When the sheath 11 meanders in the human body, it tends to twist the first wire 111 and the second wire 112, and physical interference, friction, and electrical radio frequency energy interference may occur between the first wire 111 and the second wire 112; in one embodiment, first and

second wires

111, 112 are disposed on opposite sides of the axis of sheath 11. I.e. both are spaced apart at least in the circumferential direction, and in one aspect, the path of extension within the sheath may be axial to the sheath, or may be offset or even slightly helical, to provide the necessary length compensation during bending of the sheath.

The first conductive line 111 and the second conductive line 112 are arranged as separated as possible during production, so that the stability of the first conductive line 111 and the second conductive line 112 can be effectively improved.

In the using process of the electrotome device, various using modes are possible according to different conditions of a focus, so that the electrotome device adopts a modularized design and can be flexibly combined to realize functions under different conditions. In one embodiment, a second terminal is mounted on the handle 12 and the proximal end of the second wire 112 is electrically connected to the second terminal.

The second connection terminal can provide a standard interface for the second electrode 15, so that the production and the use of matched equipment are facilitated.

In this embodiment, the second connection terminal is built in the first connection terminal 121 and shares an external interface, so that the number of interfaces of the whole device can be simplified, misoperation can be reduced, and operation feeling and stability can be improved.

In the actual treatment process of the electrotome device, a plurality of stages exist, and the working state of each part in each stage can generate difference. In one embodiment, a second switch 162 for controlling the on/off of the second wire 112 is disposed at the proximal end of the sheath 11, and the second switch 162 is directly disposed on the handle 12 or fixed on the sheath 11.

For example, when the second electrode 15 is not close to the target tissue, the second electrode 15 is in a standby state, and does not release the radio frequency energy to avoid causing damage to normal tissues; when the second electrode 15 is in place, the radio frequency energy needs to be released, so that the second switch 162 can accurately control the working state of the second electrode 15, and operation of medical staff and other operators is facilitated.

The second switch 162 may also be disposed in a control panel in combination with the first switch in the foregoing embodiments, and similarly, the control panel may also be integrally installed with a switch for opening and closing other devices (such as a negative pressure device, etc., hereinafter).

Referring to fig. 10a to 12, in an embodiment, the electric knife device includes a sheath 11, a handle 12 connected to a proximal end of the sheath 11, and a first electrode 13 connected to a distal end of the sheath 11, the first electrode 13 is a cylindrical structure, a distal end side of the first electrode 13 in an axial direction is a cutting working portion 131, and a proximal end side of the first electrode 13 in the axial direction is a connecting portion 132 fixed to the sheath 11.

The electric knife device in the embodiment further comprises an anchoring head 17 and an anchoring core 18 connected with the anchoring head 17, the anchoring core 18 defines a threading path in the use state, and the sheath 11 is slidably sleeved on the anchoring core 18 and can move towards the far end along the threading path.

The action of the anchoring core 18 defines the threading path axially in itself so as to guide the movement of the sheath 11, while enabling the movement of the first electrode 13 and other components on the threading path, since the first electrode 13 and other components are fixed to the sheath 11. This design is mainly intended to overcome the positioning problem of the first electrode 13. In the field of intervention, how to accurately position a treatment device near a target tissue and perform treatment and adjust the spatial state during the treatment process is always a difficult problem. The anchor head 17 can form an anchor point on the human tissue before the treatment process is started, so that the adjustment of the space state of the parts of the human body internal parts can be conveniently realized by matching with the adjustment of the near end.

In the actual design process, the anchor head 17 may have various shapes such as a barb shape for preventing the escape, a spherical shape for making the positioning accuracy inconspicuous, and the like. In particular, in one embodiment, the distal side of the anchor head 17 is tapered to form a tip.

Anchoring is very sensitive to positioning accuracy and can have a large impact on the therapeutic effect. Therefore, the convergent anchor head 17 can accurately position the human tissue, and more importantly, in the existing cooperation means in the interventional field, such as B-mode ultrasound, CT and the like, the shape is a feature which is easy to observe, so that the accurate operation of operators such as medical staff can be facilitated.

The anchor head 17 serves to form an anchor point, and various methods such as a suction cup or the like for forming suction effect to human tissue by negative pressure are available. However, the common design has the disadvantages of the need of separately establishing pipelines, great influence on the internal environment of the human body and the like.

In one embodiment, at least a portion of the anchor head 17 is a working portion made of a conductive material, and a third wire 113 electrically connected to the working portion is inserted into the anchor core 18.

The working part actually forms the effect of an electrode and can release radio frequency energy to human tissues, thereby realizing the working processes of cutting, ablation, electric coagulation and the like. However, when implemented on the anchor head 17, its primary purpose is not treatment, but to form an anchor point to facilitate subsequent treatment procedures. The third wire 113 is used to deliver radio frequency energy to the working portion.

The anchor head 17 can be ablated to form a small hole at an expected tissue part after being electrified, then the tip of the anchor head is used for guiding the anchor head to penetrate through the small hole, the anchor head 17 is expanded relative to the anchor core 18 as a whole, and has obvious mutation in the radial direction, and after being placed into the small hole formed by ablation, the anchor head 17 can be limited and held in the small hole to realize positioning.

The choice of the configuration of the anchor head 17 can take many forms. In one embodiment, the anchor head 17 includes a proximal cylindrical section 171 and a distal conical section 172; the third wire 113 is connected to the conical section 172 through the cylindrical section 171.

In the actual working process, the conical section 172 and the cylindrical section 171 play a role together to form an anchoring point, and in the anchoring process with the anchoring point, the conical surface of the conical section 172 can form a guiding function, so that the positioning is convenient to implement; the cylindrical section 171 can play a role of coming off prevention, and holds the anchor head 17 in the anchor point, thereby providing a stable anchoring effect for the electrotome device.

In one embodiment, the anchor head 17 is entirely of a conductive material, i.e., as a conductive portion.

The conductive material can realize the working effect of the electrode and release radio frequency energy to human tissues. In a specific design, the anchor head 17 may not be entirely made of a conductive material, for example, the outer peripheral surface is made of a conductive material for releasing electromagnetic energy, and the inner portion is made of another material for realizing other functions, and the specific material may be selected according to specific working conditions.

The third wire 113 may optionally be threaded into the sheath 11 during the threading process. The advantage of this solution is the ease of production. However, the sheath 11 itself can move relative to the anchor core 18, and therefore, abrasion of the third wire 113 by the sheath 11 may occur.

In one embodiment, the anchoring core 18 is tubular, with the interior of the tube being the passage for the third wire 113;

the proximal end of the anchor head 17 is provided with a first mounting groove 173, the distal end of the anchor core 18 is inserted and fixed in the first mounting groove 173, and a sudden change of the radial dimension is formed between the proximal end of the anchor head 17 and the anchor core 18.

The outer peripheral surface of the anchor core 18 is used for guiding the movement of the sheath 11, and the inside is used for passing the third wire 113, actually, the third wire 113 is provided in various ways, and can freely move inside the anchor core 18, or be fixed inside the anchor core 18, or be passed through the wall of the anchor core 18, and so on. The anchoring core 18 can provide protection for the third conductive wire 113, and prevent foreign substances such as gas, liquid, and solid from affecting the function of the third conductive wire 113. The third conductive wire 113 may be a composite structure with an outer layer of insulating material and an inner layer of conductive material, or may be a single conductive material, since the anchoring core 18 itself can provide shielding and protection for the third conductive wire 113. The abrupt change in radial dimension between the anchor head 17 and the anchor core 18 facilitates tissue entrapment in positioning the anchor head 17.

In one embodiment, the bottom of the first mounting groove 173 is formed with a second mounting groove 174, and the distal end of the third wire 113 is welded and fixed in the second mounting groove 174.

In the embodiment, the welding refers to stable electrical connection, and specifically, there are various implementation forms, for example, electrical connection and physical fixation are achieved through a third-party welding medium; electrical connection and physical fixation is again achieved, for example, by partial melting of the electrically conductive material of the third wire 113 or of the anchor head 17. This connection fixing mode needs to satisfy three conditions: a stable electrical connection capable of delivering radio frequency energy to the anchor head 17; the two higher strength physical connections need not be easily defeated by an external force applied to the anchor head 17; the inertia of the material is also considered because the material inertia is high, the material cannot react with other substances, the position is exposed to the internal environment of the human body when in the human body, and if various metal materials exist at the welding position, the electrochemical reaction is easy to generate by adding current and a humid environment.

In the using process of the electrotome device, various using modes are possible according to different conditions of a focus, so that the electrotome device adopts a modularized design and can be flexibly combined to realize functions under different conditions. In one embodiment, an anchor head control handle 181 is mounted to the proximal end of the anchor core 18, a third wire connection terminal 182 is mounted to the anchor head control handle 181, and the proximal end of the third wire 113 is electrically connected to the third wire connection terminal 182.

The third connection terminal 182 can provide a standard interface for the anchor head 17, thereby facilitating the production and use of the matching device.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The double-electrode electric knife device comprises a sheath tube, a handle connected to the near end of the sheath tube and a first electrode connected to the far end of the sheath tube, and is characterized in that the first electrode is of a cylindrical structure, the axial far end side of the first electrode is a cutting working part, and the axial near end side of the first electrode is a connecting part fixed with the sheath tube;

2. An electrotome device according to claim 1, wherein the distal side and/or the proximal side of the second electrode is further provided with a heat insulating ring secured to the outer circumference of the sheath.

3. The electrotome device according to claim 2, wherein the axial length of the heat insulating ring is 0.5 to 2 mm.

4. The electrotome device according to claim 1, wherein the second electrode has an axial length of 5 to 12 mm.

5. The electrotome device according to claim 1 wherein the ratio of the axial length of the second electrode to the first electrode is 5/6-2.

6. The electrotome device according to claim 1, wherein the second electrode is spaced from the first electrode by 0.5 to 4mm in the axial direction.

7. The electrotome device according to claim 1 wherein the distal side of the first wire is welded to the inner wall of the first electrode;

8. The electrotome device according to claim 1 further comprising an anchor head and an anchor core connected to the anchor head, the anchor core defining a threading path in use, the sheath being slidably disposed over the anchor core and being movable distally along the threading path.

9. The electrotome device according to claim 8 wherein the distal side of the anchor head is tapered to form a tip.

10. The electrotome device according to claim 8 wherein at least a portion of the anchor head is a working portion of an electrically conductive material and wherein a third wire is threaded through the anchor core for electrical connection to the working portion.