Electrotome device

Abstract

The present application discloses an electrotome device, which includes 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. It is characterized in that the first electrode is a cylindrical structure, the distal side in the axial direction of the first electrode is a cutting working part, and the proximal side in the axial direction of the first electrode is a connecting part fixed to the sheath tube; the electrotome device further includes: a cold anchor head, the inside of the cold anchor head is provided with a heat exchange cavity; a delivery tube, which is communicated with the heat exchange cavity and is used to deliver a cooling medium to the cold anchor head to adjust the temperature of the cold anchor head. The delivery tube defines a threading path, and the sheath tube is slidably sleeved on the delivery tube and can move distally along the threading path. The technical solution disclosed in the present application has accurate positioning during the treatment process, diverse treatment means, controllable treatment process, good treatment effect, and is not easy to relapse.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an electrotome device. Background Art

[0002] At present, lung diseases have a great impact on people's production and life, especially chronic obstructive pulmonary disease (COPD) and pulmonary bulla, etc. Among them, chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. COPD is usually characterized by airflow obstruction, especially restricting the ventilation volume of patients during exhalation. Patients with chronic bronchitis have chronic cough accompanied by sputum production, resulting in expiratory obstruction. In patients with emphysema, the destruction of lung parenchyma can lead to loss of elastic recoil, reduced airway range, expiratory obstruction, and cough. Pulmonary bulla (also called pulmonary bulla) refers to an air-containing cavity formed in lung tissue due to the increase of alveolar cavity pressure caused by various reasons, resulting in the rupture of alveolar walls and their fusion with each other.

[0003] In clinical treatment, surgical operation is a common choice. However, if the diseased part of the lung is removed through surgery, the operation usually causes a reduction of about 15 - 30% in the effective lung volume, which may not be sufficient to cause a significant improvement in lung function. At the same time, for lung cancer patients who are older, have a weak constitution, poor cardiopulmonary function, or have complications, etc., they are not suitable for or intolerant to conventional surgical resection therapy.

[0004] Therefore, minimally invasive surgery has gradually come into people's view, such as many local treatment methods like tumor minimally invasive ablation. Minimally invasive ablation of lung tumors includes radiofrequency ablation (RFA), cryoablation, microwave ablation, etc. Among them, only radiofrequency ablation is included in the clinical guidelines for non-small cell lung cancer of the National Comprehensive Cancer Network of the United States.

[0005] The principle of radiofrequency ablation is to apply an alternating high-frequency current with a frequency less than 30 MHz (usually between 460 and 480 kHz) to cause high-speed oscillation of ions in tumor tissues, and they rub against each other, converting radiofrequency energy into heat energy, so that tumor cells undergo coagulative necrosis. In radiofrequency ablation treatment, the instrument used is an electrotome, and the electrode at its distal end can transmit radiofrequency energy to the cell tissue around the puncture site after percutaneous puncture. During radiofrequency ablation treatment, the electrode of the electrotome is connected to the radiofrequency generator. Under the guidance of B-ultrasound or CT, percutaneous puncture is performed, and the target tumor is punctured through the puncture point. The neutral electrode is also connected to the radiofrequency generator, and it is attached to a suitable part of the patient's body. When the foot switch on the radiofrequency generator is pressed, a circuit is established and connected between the electrode of the electrotome and the neutral electrode in the human tissue, and the high-frequency current acts on the human tissue between the two, causing the tumor cells contacted by the electrode at the distal end of the electrotome to coagulate, degenerate, and necrosis.

[0006] The inventors found that when the existing electrocautery for the lungs is in operation, even with the guidance of B-ultrasound or CT, the existing radiofrequency ablation operation cannot effectively determine the accurate position of the front-end electrode of the radiofrequency ablation catheter. CT images are a limited number of cross-sectional images scanned by X-rays. At certain angles, it may seem that the front-end electrode is placed at the target site, but the actual position may be incorrect, and it is only overlapping in the projection direction. Therefore, it is difficult to determine the position of the front-end electrode, and the positioning accuracy is insufficient.

[0007] During some treatment processes, it may be necessary to pull on the lesion or surrounding tissues, and the solutions in the related technologies generally cannot complete this action. Because the treatment means are relatively single, there is a problem that after the blocked part is opened by the existing treatment means, the lesion area will be blocked again after the operation, and the treatment effect is not good. Summary of the Invention

[0008] To solve the above technical problems, the present application discloses an electrocautery device, including 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. The first electrode is a cylindrical structure. The distal side in the axial direction of the first electrode is the cutting working part, and the proximal side in the axial direction of the first electrode is a connecting part fixed to the sheath tube.

[0009] The electrocautery device further includes:

[0010] A cold anchor, the inside of which has a heat exchange cavity;

[0011] A delivery tube, communicating with the heat exchange cavity and used to deliver a cooling medium to the cold anchor to adjust the temperature of the cold anchor. The delivery tube defines a threading path, and the sheath tube is slidably sleeved on the delivery tube and can move distally along the threading path.

[0012] The following also provides several optional ways, which are not additional limitations to the above overall solution, but are only further supplements or optimizations. Without technical or logical contradictions, each optional way can be combined with the above overall solution separately, or multiple optional ways can be combined with each other.

[0013] Optionally, the heat exchange cavity opens at the proximal side of the cold anchor, and the delivery tube is docked at this opening part.

[0014] Optionally, the delivery tube is sleeved and fixed on the proximal side of the cold anchor.

[0015] Optionally, the cold anchor is cylindrical and closed at the distal end, and the inside of the cylinder is the heat exchange cavity, and the delivery tube is docked and communicated to the proximal end of the cylinder.

[0016] Optionally, the cold anchor head has a first working surface facing the distal end and a second working surface located at the outer periphery of the cylinder, and the surface of each working surface is smooth.

[0017] Optionally, the delivery pipe comprises an outer pipe and an inner pipe which are nested, a first channel is provided in the inner pipe, and a second channel is provided in a gap between the outer pipe and the inner pipe;

[0018] The first channel and the second channel intersect and communicate with each other in the heat exchange chamber;

[0019] The first channel, the second channel and the heat exchange chamber form a cooling medium circuit.

[0020] Optionally, the outer tube sealing sleeve is arranged on the proximal side of the cold anchor head, and the end of the inner tube extends into the heat exchange chamber.

[0021] Optionally, outer circumferential surfaces of the butt joint between the outer tube and the cold anchor head are flush with each other.

[0022] Optionally, the distal end of the inner tube is a bevel structure.

[0023] Optionally, a cold anchor head control handle is installed at the proximal end of the delivery tube, and the cold anchor head control handle includes a shell, and two mutually isolated switching chambers are defined in the shell, and each switching chamber is also connected to a switching joint for connecting to an external pipeline.

[0024] Optionally, each of the adapter cavities is directly opened in the shell, or a adapter is provided in the shell, and each of the adapter cavities is opened in the adapter.

[0025] Optionally, the delivery tube includes an outer tube and an inner tube that are nested, and the outer tube and the inner tube are respectively connected to a corresponding transfer cavity.

[0026] Optionally, there is a portion of a common cavity wall between the two transition cavities, the outer tube and the inner tube penetrate into one of the transition cavities, and only the inner tube passes through the common cavity wall to enter the other transition cavity.

[0027] Optionally, the outer tube and the inner tube are respectively fixed to the cavity walls of corresponding parts of the transition cavity, so that the outer tube and the inner tube maintain a relative axial position.

[0028] Optionally, a traction wire is passed through the delivery tube, and the distal end of the traction wire is connected to the cold anchor head for adjusting the posture of the cold anchor head; a cold anchor head control handle is installed at the proximal end of the delivery tube, and the cold anchor head control handle is provided with a control component that is linked to the proximal end of the traction wire.

[0029] This application realizes the positioning of the electrode through a cold anchor head with a heat exchange cavity, facilitating the implementation of treatment processes such as ablation, coagulation, and electrocision. During the treatment process, the positioning is accurate, the treatment means are diverse, the treatment process is controllable, the treatment effect is good, and recurrence is not easy.

[0030] The specific beneficial technical effects will be further explained in combination with the specific structure in the specific implementation manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of an electrocautery device in an embodiment;

[0032] Figure 2 is Figure 1 Schematic cross-sectional view of the electrocautery device in

[0033] Figure 3 is Figure 1 Schematic diagram of the internal structure of the electrocautery device in

[0034] Figure 4a is Figure 1 Schematic diagram of the cooperation between the first electrode and the sheath tube in

[0035] Figure 4b is Figure 1 Perspective schematic diagram of the cooperation relationship between the first electrode and the sheath tube in

[0036] Figure 5 is Figure 1 Schematic diagram of the structure of the first electrode in

[0037] Figure 6 Schematic diagram of an electrocautery device in an embodiment;

[0038] Figure 7 is Figure 6 Schematic cross-sectional view of the electrocautery device in

[0039] Figure 8 is Figure 6 Schematic diagram of the first electrode and the second electrode in

[0040] Figure 9 is Figure 6 Schematic diagram of the cooperation between the first electrode, the second electrode and the sheath tube in

[0041] Figure 10a Schematic diagram of an electrocautery device in an embodiment;

[0042] Figure 10b Schematic diagram of the anchoring core and the anchoring head in FIG. 10;

[0043] Figure 11a Schematic diagram of the sheath tube advancing along the anchoring core in FIG. 10;

[0044] Figure 11bSchematic diagram of the sheath tube retracting along the anchoring core in FIG. 10;

[0045] Figure 12 Schematic diagram of the internal structure of the anchoring head in FIG. 10;

[0046] Figure 13 Schematic diagram of the structure of the electrosurgical knife device in an embodiment;

[0047] Figure 14a It is Figure 13 Schematic diagram of the delivery tube, cold anchoring head and cold anchoring head control handle in;

[0048] Figure 14b It is Figure 13 Schematic diagram of the cross-section of the intermediate adapter, delivery tube and cold anchoring head in;

[0049] Figure 15 It is Figure 13 Schematic diagram of the internal structure of the electrosurgical knife device in;

[0050] Figure 16 It is Figure 13 Schematic diagram of the internal structure of the cold anchoring head in;

[0051] Figure 17 It is Figure 13 Schematic diagram of the internal structure of the cold anchoring head operating handle in;

[0052] Figure 18 Schematic diagram of the electrosurgical knife device in an embodiment;

[0053] Figure 19 It is Figure 18 Schematic diagram of the proximal side structure of the traction wire in;

[0054] Figure 20 It is Figure 18 Schematic diagram of the distal side structure of the traction wire in.

[0055] The descriptions of the reference numerals in the figure are as follows:

[0056] 11. Sheath tube; 111. First wire; 1111. Distal end of the first wire; 1112. First wire sheath; 1113. First wire through hole; 112. Second wire; 1121. Distal end of the second wire; 113. Third wire;

[0057] 12. Handle; 121. First terminal;

[0058] 13. First electrode; 131. Cutting working part; 132. Connecting part; 1321. Through hole;

[0059] 14. Pipe joint; 15. Second electrode; 151. Heat insulation ring; 161. First switch; 162. Second switch;

[0060] 17. Anchor head; 171. Cylindrical section; 172. Conical section; 173. First installation groove; 174. Second installation groove;

[0061] 18. Anchor core; 181. Anchor head control handle; 182. Third terminal;

[0062] 19. Cold anchor head; 191. Heat exchange cavity; 192. First working surface; 193. Second working surface;

[0063] 20. Delivery pipe; 21. Inner pipe; 211. Groove structure; 22. Outer pipe; 221. Traction groove; 23. Cold anchor head control handle; 230. Adapter; 231. Housing; 2311. Guide groove; 232. Adapter cavity; 233. Adapter joint; 234. Common cavity wall; 235. Adapter through hole;

[0064] 24. Traction wire; 241. Traction wire pull head; 242. Extension channel;

[0065] 25. Control component; 251. Locking part; 252. Operation part; 253. Traction part; 2531. First receiving cavity; 2532. Second receiving cavity; 2533. Traction wire through hole; 254. Transmission part; 2541. Pressure plate; Detailed implementation mode

[0066] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0067] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0068] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention belongs. The terms used herein in the description of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the related listed items.

[0069] Refer to Figures 1 to 2, one embodiment of the present application discloses an electrosurgical device, including a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a cylindrical structure. The distal side in the axial direction of the first electrode 13 is a cutting working part 131, and the proximal side in the axial direction of the first electrode 13 is a connecting part 132 fixed to the sheath 11.

[0070] The electrosurgical device sends the first electrode 13 into the human body through the sheath 11 and approaches the target tissue. By releasing radiofrequency energy from the first electrode 13 to the target tissue, a series of treatment processes such as cutting, ablation, and electrocoagulation of the target tissue can be achieved. In this embodiment, the first electrode 13 is preferably a cylindrical structure, similar to the common structure of the sheath 11, which is convenient for setting the connecting part 132 at the proximal end in the axial direction of the first electrode 13, so as to realize a stable connection with the sheath 11. The cutting working part 131 on the distal side in the axial direction of the first electrode 13 is used to directly make electrical contact with the target tissue, so as to release radiofrequency energy and realize its function. The cylindrical structure of the first electrode 13 can provide multiple functions for the cutting working part 131. For example, when used in treatment processes such as cutting, the cutting working part 131 can approach the target tissue through the bottom surface of the cylindrical structure, and use the thinner side wall of the cylindrical structure to form a smaller contact area, which is convenient for cutting; when used in treatment processes such as ablation, the cutting working part 131 can approach the target tissue through the circumferential surface of the cylindrical structure, so as to form a larger contact area. Thus, a treatment process of first electrocuting and then electrocoagulating can be realized, reducing the possibility of recurrence of the lesion. In specific operations, it can be selected to first electrocut to form a through channel, and aspirate the cut tissue through negative pressure vacuum, and then electrocoagulate and form a scab, so as to achieve the technical effect of avoiding re-blockage during postoperative healing.

[0071] In one embodiment, the proximal end of the sheath 11 penetrates and is fixed to the handle 12, and a pipe joint 14 for connecting an external device is installed on the part of the sheath 11 that penetrates out of the handle 12.

[0072] In the actual complex treatment process, at different treatment stages, the electrosurgical device often needs to be connected to a variety of external devices to achieve different treatment functions. Therefore, the design of the pipe joint 14 can facilitate the access of external devices, reduce the workload of operators such as medical staff, enable operators and the like to focus more on the treatment process, and improve the experience.

[0073] There are various design forms of the pipe joint 14, which can be adjusted according to different usage scenarios and requirements, and a more common interface in the field can also be adopted to improve the versatility, such as a Luer connector, etc.

[0074] Refer to Figures 1 to 5, in one embodiment, the electrosurgical device includes a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a cylindrical structure. The distal side in the axial direction of the first electrode 13 is a cutting working portion 131, and the proximal side in the axial direction of the first electrode 13 is a connecting portion 132 fixed to the sheath 11. The cutting working portion 131 of the first electrode 13 is a circumferentially closed structure.

[0075] The circumferentially closed structure refers to the existence of a path that wraps around the outer peripheral surface of the first electrode 13 end to end for one week, and there is no large-area hollowing on the outer peripheral surface of the first electrode 13. This design can provide better mechanical strength for the first electrode 13, avoiding accidental situations such as breakage and falling parts in the human body; and tissues in the human body are not easily blocked and interfered with the first electrode 13, thus facilitating the use by the operator. In a specific design, the circumferentially closed structure can be adjusted as needed, such as opening holes to avoid certain entities, etc. Therefore, the circumferentially closed structure is not completely closed in an absolute sense. In some embodiments, it is necessary to meet the line contact for cutting the target tissue and the surface contact for ablation and electrocoagulation. Of course, in some embodiments, the cutting working portion 131 of the first electrode 13 is completely closed in the circumferential direction, that is, there is no hollow part.

[0076] According to different lesions and situations, the shape of the end of the cutting working portion 131 can be adjusted as needed. In one embodiment, the end of the cutting working portion 131 is flat or pointed.

[0077] The end of the cutting working portion 131 is the part that directly contacts the target tissue. Generally, during treatment such as cutting, the end of the cutting working portion 131 is the part that directly acts on the target tissue. When the shape of the end of the cutting working portion 131 changes, some additional technical advantages will be brought. For example, when the end of the cutting working portion 131 is pointed, it can provide a smaller contact area with the target tissue, which is convenient for treating smaller target tissues. The different technical advantages of different structures are also the reasons for selecting different structures as needed.

[0078] When the end of the cutting working portion 131 is flat, combined with the first electrode 13 being a cylindrical structure, the cutting working portion 131 cuts the target tissue through the side wall of the cylindrical structure; when the end of the cutting working portion 131 is pointed (not shown in the figure), the cutting working portion 131 can cut the target tissue through the tip of the pointed end.

[0079] The axial length of the cutting working portion 131 determines two indicators. One is the maximum depth that the first electrode 13 can cut the target tissue, and the other is the maximum contact area that can contact the target tissue. These two indicators directly affect the progress of the treatment process and the treatment effect. In one embodiment, the axial length of the cutting working portion 131 of the first electrode 13 is 4 - 6 mm.

[0080] When the length of the cutting working part 131 of the first electrode 13 is too short, the cutting depth is small, and it is inconvenient to operate when the target tissue is thick; when the length of the cutting working part 131 of the first electrode 13 is too long, it is not conducive to the implementation of the intervention process, and it is more inconvenient for the longer first electrode 13 to travel in the human body. Therefore, the axial length of the cutting working part 131 of the first electrode 13 is preferably 4-6 mm.

[0081] Compared with the flexibility of the sheath 11, the first electrode 13 is rigid and not easily bent in the human body. Therefore, in order to facilitate the implementation of the intervention process, there are certain requirements for the total length of the first electrode 13 in the axial direction. Therefore, the length ratio of the cutting working part 131 to the connecting part 132 needs to be adjusted. The actual working process of the electrotome device is realized by the cutting working part 131. Therefore, from a functional point of view, the longer the cutting working part 131, the more available parts there are; however, the fixation of the first electrode 13 is realized by the connecting part 132. The first electrode 13 inserted into the human body will be subjected to external forces such as extrusion and pulling by human tissues. Without a stable connection, the component connection will fail, resulting in the termination of the treatment process at worst, or leaving components in the human body to cause new problems at worst. Therefore, both the cutting working part 131 and the connecting part 132 have certain requirements for the length. In an embodiment, the axial length ratio of the cutting working part 131 to the connecting part 132 of the first electrode 13 is 1:0.3-3.

[0082] In different scenarios, the axial length ratio of the cutting working part 131 to the connecting part 132 is 1:0.3-3. Correspondingly, when the length of the connecting part 132 becomes short, corresponding structures or technical means need to be designed to ensure the connection effect.

[0083] In some preferred embodiments, the axial length ratio of the cutting working part 131 to the connecting part 132 of the first electrode 13 is 1:0.5-2.

[0084] During the use of the electrotome device, the first electrode 13 is always kept together with the sheath 11, so there is no need for separate use. The sheath 11 is generally made of plastic material, and the first electrode 13 and the sheath 11 can be formed as one body during the production process. In an embodiment, the connecting part 132 of the first electrode 13 has a hollowed-out area, and a part or all of the hollowed-out area is embedded and fixed in the tube wall of the sheath 11.

[0085] It should be noted that in this embodiment, the first electrode 13 is made of a conductive material, while the sheath 11 is made of an insulating material. The difference in materials may cause problems in the cooperation between the first electrode 13 and the sheath 11. Especially during temperature changes, the originally tight fitting relationship may cause connection failure due to different expansion coefficients. A stable connection between components is very important in the intervention field because the detachment of components will have a great impact on the human body. The role of the hollowed-out area is to change the limit between the two materials through frictional force to the limit through the abutment of a part of the structure. In this embodiment, the plastic material of the sheath 11 will enter the hollowed-out area during molding, so as to abut against the boundary of the hollowed-out area, thereby preventing the relative movement between the first electrode 13 and the sheath 11. On the premise of the same technical idea, in some other embodiments, the form of the hollowed-out area may be deformed. For example, a part of the material of the first electrode 13 protrudes from its outer peripheral surface, and the sheath 11 will wrap the protrusion of the first electrode 13 during molding, thereby preventing the relative movement between the first electrode 13 and the sheath 11.

[0086] Because in the intervention field, the first electrode 13 directly acts on human tissue, various situations such as torsion, adhesion, and traction may occur. The first electrode 13 needs to be able to maintain a stable connection with the sheath 11 under stresses in various directions. In one embodiment, the hollowed-out area includes a plurality of through holes 1321, and each through hole 1321 is distributed along the circumferential direction of the first electrode 13.

[0087] The circumferentially arranged through holes 1321 can limit the relative movement between the first electrode 13 and the sheath 11 in the circumferential direction. This design is very important in the intervention field, so the circumferential arrangement of the through holes 1321 can greatly improve the connection strength between the first electrode 13 and the sheath 11.

[0088] In one embodiment, the through holes 1321 are divided into two to four groups, and the groups are arranged in sequence along the axial direction of the first electrode 13, and the through holes 1321 in the same group are distributed along the circumferential direction of the first electrode 13.

[0089] After the through holes 1321 are distributed in multiple groups, an array-type hollowed-out area is formed on the outer peripheral surface of the connecting portion 132 of the first electrode 13, which can effectively improve the connection strength between the sheath 11 and the first electrode 13 and improve the stability of the electrosurgical device. When the first electrode 13 is subjected to a force, the stresses received by the through holes 1321 at different positions along the axial direction of the first electrode 13 are not necessarily the same. For example, when the first electrode 13 is subjected to a tensile or thrust force along its own axial direction, the stress directions of each through hole 1321 are all along the circumferential direction of the first electrode 13; when the first electrode 13 is subjected to a torsional stress, the through holes 1321 arranged in different positions will receive stresses with different directions and magnitudes.

[0090] In one embodiment, the through-holes 1321 between adjacent groups are aligned with each other in the circumferential direction of the first electrode 13. Each through-hole 1321 actually acts as a fixed point. Therefore, the through-holes 1321 arranged in alignment with each other actually provide more fixed points, which is beneficial to improving the stability of the first electrode 13 in its own axial direction and enhancing the stress resistance in this direction.

[0091] In other embodiments, the through-holes 1321 between adjacent groups are arranged in a staggered manner in the circumferential direction of the first electrode 13. The through-holes 1321 arranged in a staggered manner achieve denser fixed points with a certain number of through-holes 1321. Therefore, the first electrode 13 can be selected as needed according to different situations.

[0092] In one embodiment, the number of through-holes 1321 in the same group is 1, 2, 3, 4, 5, or 6.

[0093] An increase in the number of through-holes 1321 can bring a more stable connection effect, but the setting of the through-holes 1321 will affect the structural strength of the first electrode 13 itself. Therefore, in actual production, it is necessary to control the total area of the through-holes 1321 so as not to reduce the structural strength of the first electrode 13 due to the opening of the through-holes 1321. Generally speaking, the number of through-holes 1321 and the cross-sectional area of a single through-hole 1321 are negatively correlated, and the cross-sectional areas of each through-hole 1321 are not very different.

[0094] In one embodiment, the shapes of the through-holes 1321 are the same. For one of the through-holes 1321, its inner edge is a polygon or a smooth curve. Of course, in other embodiments, the shapes of the through-holes 1321 can also be different.

[0095] The cross-sectional shape of the through-hole 1321 will also affect the connection effect of the connecting portion 132. For example, when the cross-sectional shape of the through-hole 1321 is a shape with a sharp included angle, stress concentration is likely to occur at the included angle position. At this time, the sheath 11 and the through-hole 1321 may cut each other, resulting in the possibility of connection failure, which needs to be overcome by increasing the number of through-holes 1321 and optimizing the arrangement positions. Therefore, the shapes of the through-holes 1321 are preferably polygons or smooth curves on the inner edge.

[0096] In one embodiment, some or all of the through-holes 1321 are rectangular.

[0097] For example, when the cross-sectional shape of the through-hole 1321 is rectangular, the acting areas of the sheath 11 and the first electrode 13 at the contacting part of a single through-hole 1321 in the axial and circumferential directions are larger, improving the connection stability. More importantly, a rectangular shape is a structure that is more convenient for production during the production process and is easier to control the accuracy. Therefore, selecting through-holes 1321 with a rectangular cross-section can effectively reduce the production cost, and this design takes into account both the effectiveness of the connection and the requirements of the production process.

[0098] In one embodiment, a first wire 111 is embedded in the tube wall of the sheath tube 11. The proximal end of the first wire 111 extends to the handle 12, and the distal end 1111 of the first wire is electrically connected to the first electrode 13.

[0099] The function of the first wire 111 is to establish an electrical connection between the radiofrequency source and the first electrode 13 for delivering radiofrequency energy to the first electrode 13. The first wire 111 is embedded in the sheath tube 11 and travels through the human body following the sheath tube 11. Generally, the first wire 111 is fixedly connected to the sheath tube 11, that is, no relative displacement can occur. This design is mainly achieved by forming the first wire 111 and the sheath tube 11 into an integral structure during the production process. The sheath tube 11 can provide protection for the first wire 111 to prevent external impurities such as gas, liquid, and solid from affecting the function of the first wire 111. The first wire 111 can be a composite structure with an insulating material on the outer layer and a conductive material on the inner layer, or it can be a single conductive material because the sheath tube 11 itself can provide shielding and protection for the first wire 111. In this embodiment, a first wire through-hole 1113 for the first wire 111 to pass through is provided on the sheath tube 11, and the first wire 11 passes through the first wire through-hole 1113 through the first wire sheath 1112. The first wire sheath 1112 and the sheath tube 11 jointly protect the first wire 111.

[0100] The first wire 111 needs to be electrically connected to the first electrode 13 to realize the function of the electrotome device. Therefore, various structures can be designed on the first electrode 13 to fix the first wire 111. For example, a clamping component for clamping the first wire 111 is provided on the first electrode 13, etc.

[0101] In one embodiment, the distal end 1111 of the first wire is welded and fixed to the inner wall of the first electrode 13.

[0102] In this embodiment, the welding referred to is a stable electrical connection, and there are various specific implementation forms. For example, the electrical connection and physical fixation are realized through a third-party welding medium; for another example, the electrical connection and physical fixation are realized by melting a part of the conductive material of the first wire 111 or a part of the first electrode 13. This connection and fixation method need to meet three conditions: a stable electrical connection that can deliver radiofrequency energy to the first electrode 13; a relatively high-strength physical connection that does not easily fail when the first electrode 13 is subjected to external forces; and a relatively high inertness that does not react with other substances. When in the human body, this position is exposed to the internal environment of the human body. If there are multiple metal materials at the welding position, plus the current and humid environment, electrochemical reactions are likely to occur. Therefore, the inertness of the materials also needs to be considered.

[0103] During the use of the electrocautery device, there may be multiple usage methods according to different conditions of the lesion. Therefore, adopting a modular design can more flexibly combine functions according to different situations. In one embodiment, a first terminal 121 is installed on the handle 12, and the proximal end of the first wire 111 is electrically connected to the first terminal 121.

[0104] The first terminal 121 can provide a standard interface for the first electrode 13, facilitating the production and use of supporting equipment.

[0105] During the actual treatment process of the electrocautery device, there are multiple stages, and the working states of each component will vary in each stage. For example, when the first electrode 13 is not close to the target tissue, the first electrode 13 is in a standby state and does not release radiofrequency energy to avoid damaging normal tissues; when the first electrode 13 is in place, it needs to start releasing radiofrequency energy. In one embodiment, a first switch 161 (as shown in Figure 6 ) for controlling the on / off of the circuit of the first wire 111 is provided on the proximal side of the sheath 11. The first switch 161 is directly arranged on the handle 12 or fixed on the sheath 11.

[0106] The first switch 161 can accurately control the working state of the first electrode 13, facilitating operation by medical staff and other operators. However, in some cases, the first switch 161 cannot be arranged on the handle 12 or fixed on the sheath 11. For example, in the technical solution shown in Figure 1 , the first switch 161 is not shown. In actual situations, due to various factors such as equipment differences, lesion differences, and surgical requirements, the first switch 161 may be arranged on an external device or other parts. The same applies to the second switch 162 in the following text.

[0107] Referring to Figures 6 to 9 , in one embodiment, the electrocautery device includes a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a cylindrical structure. The distal side in the axial direction of the first electrode 13 is a cutting working part 131, and the proximal side in the axial direction of the first electrode 13 is a connecting part 132 fixed to the sheath 11; the electrocautery device further includes a second electrode 15 arranged at an interval from the first electrode 13, and the second electrode 15 is located on the proximal side of the first electrode 13.

[0108] The second electrode 15 can endow the electrotome device with more abundant functions. The advantage of this design is that it can divide the treatment processes with different requirements for the electrode shape, and design a single electrode to be more in line with the shape and characteristics of a specific treatment process. For example, the first electrode 13 is used for cutting, designed with a small contact area with a pointed tip and a longer length to facilitate deep cutting. The second electrode 15 is used for ablation, electrocoagulation, etc., with a larger circumferential area to facilitate large-area contact with the target tissue. The specific shapes and characteristics of the first electrode 13 and the second electrode 15 can be adjusted according to actual situations as needed.

[0109] To avoid interference between the first electrode 13 and the second electrode 15, spaced arrangement is a reasonable choice. The spaced arrangement specifically means that the first electrode 13 and the second electrode 15 are electrically insulated from each other. In terms of specific structures, there are various implementation forms. For example, the first electrode 13 and the second electrode 15 are arranged axially in sequence, with an insulating spacer ring provided in the middle; another example is that at least a part of the first electrode 13 and the second electrode 15 are sleeved with each other, and an insulating spacer ring is clamped between the sleeved parts; and so on.

[0110] For the convenience of threading in the human body, the second electrode 15 has a design requirement to reduce the size of the overall device to facilitate operation. In one embodiment, the second electrode 15 is in a tubular shape and is sleeved and fixed on the outer periphery of the sheath 11.

[0111] In general designs, the sheath 11 is a hollow cylinder. For the second electrode 15 to achieve a larger contact area with the target tissue, it is a reasonable preference to be sleeved on the outer periphery of the sheath 11. Therefore, the tubular second electrode 15 can effectively reduce the size of the overall device and improve the operator's experience.

[0112] In actual selection, the second electrode 15 can be selected to form partial hollowing on itself to facilitate fixation with the sheath 11. The main function of the hollowing is to facilitate part of the material of the sheath 11 to enter the inside of the second electrode 15 to achieve fixation and improve the connection strength.

[0113] During the treatment process of the electrotome device, the first electrode 13 and the second electrode 15 may act on different treatment processes, so there may be a time difference in their operations. In one embodiment, a heat insulation ring 151 fixed on the outer periphery of the sheath 11 is further provided on the distal side and / or proximal side of the second electrode 15.

[0114] The heat insulation ring 151 can eliminate the influence between the first electrode 13 and the second electrode 15, enabling the first electrode 13 and the second electrode 15 to be arranged more compactly, facilitating the implementation of the intervention process and subsequent operations.

[0115] The axial length of the heat insulation ring 151 to a certain extent determines 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 to 2 mm.

[0116] 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 the relatively humid environment in the human body, insulation failure may occur; 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 it is not convenient to operate when the electrotome device intervenes in the human body, especially in the lung area. Therefore, the axial length of the heat insulation ring 151 is preferably 0.5 to 2 mm.

[0117] Compared with the flexibility of the sheath 11, the second electrode 15 is rigid and not easily bent in the human body. Therefore, in order to facilitate the implementation of the intervention process, there are certain requirements for the total axial length of the second electrode 15. In one embodiment, the axial length of the second electrode 15 is 5 to 12 mm.

[0118] In principle, the farther the distal end of the axial length of the second electrode 15 is, the more beneficial it is to the implementation of the intervention process. However, the axial length of the second electrode 15 directly determines the contact area between the second electrode 15 and the target tissue. Therefore, considering the intervention implementation process and the treatment effect comprehensively, the axial length of the second electrode 15 is preferably 5 to 12 mm.

[0119] Both the first electrode 13 and the second electrode 15 are located on the distal side of the sheath 11. The longer the overall axial length is, the more unfavorable it is to the implementation of the intervention process. However, the axial lengths of the first electrode 13 and the second electrode 15 directly affect the direct contact area with the target tissue. Therefore, the axial length ratio of the second electrode 15 to the first electrode 13 needs to be designed. In one embodiment, the ratio of the axial length of the second electrode 15 to the first electrode 13 is 5 / 6 to 2.

[0120] Under the condition of ensuring their overall axial lengths, adjust according to different lesion conditions. When the work of the first electrode 13 is more important or a longer length is required, the length of the second electrode 15 can be appropriately shortened; when the work of the second electrode 15 is more important or a longer length is required, the length of the first electrode 13 can be appropriately shortened, so as to achieve the technical purpose of improving the treatment effect without affecting the intervention process.

[0121] The axial distance between the second electrode 15 and the first electrode 13 directly affects the insulation performance between the second electrode 15 and the first electrode 13, and also affects the arrangement of the heat insulation ring 151. In one embodiment, the axial distance between the second electrode 15 and the first electrode 13 is 0.5 to 4 mm.

[0122] If the spacing is too small, insulation failure may occur in the relatively humid environment inside the human body; when the spacing is too large, it is not convenient to operate the electrosurgical device when it intervenes in the human body, especially in the lung area. Therefore, the axial spacing between the second electrode 15 and the first electrode 13 is preferably 0.5 - 4 mm.

[0123] In order to supply power to the first electrode 13 and the second electrode 15 respectively, in one embodiment, a first wire 111 and a second wire 112 are also embedded in the tube wall of the sheath 11;

[0124] The proximal end of the first wire 111 extends to the handle 12, and the distal end 1111 of the first wire is electrically connected to the first electrode 13;

[0125] 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.

[0126] The function of the first wire 111 is to establish an electrical connection between the radiofrequency source and the first electrode 13 for delivering radiofrequency energy to the first electrode 13. The function of the second wire 112 is to establish an electrical connection between the radiofrequency source and the second electrode 15 for delivering radiofrequency energy to the second electrode 15. The first wire 111 and the second wire 112 are embedded in the sheath 11 and can follow the sheath 11 to travel inside the human body when the sheath 11 moves. Generally, the first wire 111 and the second wire 112 are fixedly connected to the sheath 11, that is, relative displacement cannot occur. This design is mainly achieved by forming an integral structure of the first wire 111, the second wire 112 and the sheath 11 during the production process. The sheath 11 can provide protection for the first wire 111 and the second wire 112 to prevent external impurities such as gas, liquid, and solid from affecting the functions of the first wire 111 and the second wire 112. The first wire 111 and the second wire 112 can be composite structures with an insulating material on the outer layer and a conductive material on the inner layer, or can be separate conductive materials, because the sheath 11 itself can provide shielding and protection for the first wire 111 and the second wire 112.

[0127] After the proximal ends of the first wire 111 and the second wire 112 extend to the handle 12 respectively, corresponding electrical connectors can be configured respectively to facilitate connection with external circuits. The form of the electrical connectors is not strictly limited, and at least good circuit conduction and necessary connection strength can be provided.

[0128] In one embodiment, the distal end 1111 of the first wire is welded and fixed to the inner wall of the first electrode 13; the distal end 1121 of the second wire is welded and fixed to the inner wall of the second electrode 15.

[0129] In this embodiment, the welding refers to a stable electrical connection, and there are various specific implementation forms. For example, the electrical connection and physical fixation are achieved through a third-party welding medium; for another example, the electrical connection and physical fixation are achieved by melting a part of the conductive material of the first wire 111 or a part of the first electrode 13. This connection and fixation method needs to meet three conditions: a stable electrical connection that can transmit radio frequency energy to the first electrode 13 and the second electrode 15; a relatively high-strength physical connection that will not easily fail when the first electrode 13 and the second electrode 15 are subjected to external forces; and a relatively high inertness that will not react with other substances. When in the human body, this position is exposed to the internal environment of the human body. If there are multiple metal materials at the welding position, plus current and a humid environment, an electrochemical reaction is likely to occur. Therefore, the inertness of the material also needs to be considered.

[0130] When the sheath 11 winds through the human body, it will generate a torsional tendency on the first wire 111 and the second wire 112. Physical interference, friction, and radio frequency energy interference in terms of electricity may occur between the first wire 111 and the second wire 112. In one embodiment, the first wire 111 and the second wire 112 are arranged on opposite sides of the axis of the sheath 11. That is, the two are at least circumferentially spaced apart. However, for either one, the extension path in the sheath can be along the axial direction of the sheath, or it can be offset or even slightly spiral, which can provide the necessary length compensation when the sheath is bent.

[0131] When manufacturing, arranging the first wire 111 and the second wire 112 as far apart as possible can effectively improve the stability of the first wire 111 and the second wire 112.

[0132] During the use of the electrosurgical device, there may be various usage methods according to different conditions of the lesion. Therefore, adopting a modular design can be more flexible in combination to achieve functions according to different situations. In one embodiment, a second terminal is installed on the handle 12, and the proximal end of the second wire 112 is electrically connected to the second terminal.

[0133] The second terminal can provide a standard interface for the second electrode 15, which is convenient for the production and use of supporting equipment.

[0134] In this embodiment, the second terminal is built into the first terminal 121 and shares an external interface, which can simplify the number of interfaces of the overall device, reduce misoperations, and improve the operation experience and stability.

[0135] During the actual treatment process of the electrosurgical device, there are multiple stages, and the working states of each component will vary in each stage. In one embodiment, a second switch 162 for controlling the on / off of the circuit of the second wire 112 is provided on the proximal side of the sheath 11, and the second switch 162 is directly set on the handle 12 or fixed on the sheath 11.

[0136] For example, when the second electrode 15 is not close to the target tissue, the second electrode 15 is in standby mode and does not release radio frequency energy to avoid causing damage to normal tissue; when the second electrode 15 is in place, it needs to start releasing radio frequency energy, so the second switch 162 can accurately control the working state of the second electrode 15, making it convenient for medical staff and other operators to operate.

[0137] The second switch 162 can also be centrally arranged on a control panel together with the first switch in the aforementioned embodiment. Similarly, switches for turning on and off other devices (such as the negative pressure device described below) can also be integrated on the control panel.

[0138] refer to Figures 10a to 12 In one embodiment, the electrosurgical unit includes a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a tubular structure, and the axial distal side of the first electrode 13 is a cutting working part 131, and the axial proximal side of the first electrode 13 is a connecting part 132 fixed to the sheath 11.

[0139] In this embodiment, the electrosurgical device further comprises an anchor head 17 and an anchor core 18 connected to the anchor head 17. When in use, the anchor core 18 defines a threading path, and the sheath 11 is slidably mounted on the anchor core 18 and can move toward the distal end along the threading path.

[0140] The function of the anchoring core 18 is to limit the threading path with its own axial direction, so as to guide the movement of the sheath 11. At the same time, because the first electrode 13 and other components are fixed on the sheath 11, the movement of the first electrode 13 and other components on the threading path can be realized. This design is mainly to overcome the positioning problem of the first electrode 13. In the field of intervention, how to accurately position the treatment equipment near the target tissue and perform treatment and adjust the spatial state during the treatment process has always been a difficult problem. The anchoring head 17 can form an anchor point on the human tissue before the treatment process begins, so as to facilitate the adjustment of the spatial state of the components in the human body with the adjustment of the proximal end.

[0141] In the actual design process, the anchor head 17 can be in various shapes, such as a barb shape to prevent disengagement, a spherical shape that is insensitive to positioning accuracy, etc. Specifically in one embodiment, the distal end side of the anchor head 17 gradually converges to form a tip.

[0142] Anchoring is very sensitive to positioning accuracy, which will have a great impact on the treatment effect. Therefore, the anchor head 17 that converges to a sharp tip can accurately locate human tissue. More importantly, in the existing interventional field cooperation methods, such as B-ultrasound, CT, etc., the shape is a feature that is easier to observe, so it is convenient for medical staff and other operators to accurately operate it.

[0143] The function of the anchoring head 17 is to form an anchoring point, which can be realized in many ways, such as forming a suction cup with an adsorption effect on human tissue by negative pressure, etc. However, common designs often have the disadvantages of requiring separate pipelines and having a significant impact on the internal environment of the human body.

[0144] In one embodiment, at least a portion of the anchor head 17 is a working portion made of conductive material, and a third wire 113 electrically connected to the working portion is passed through the anchor core 18 .

[0145] The working part actually forms the effect of an electrode, which can release radio frequency energy to human tissue, thereby achieving cutting, ablation, electrocoagulation and other working processes. However, when implemented on the anchoring head 17, its main purpose is not treatment, but to form an anchor point, thereby facilitating the subsequent treatment process. The third wire 113 is used to deliver radio frequency energy to the working part.

[0146] After the anchor head 17 is energized, it can ablate a small hole at the expected tissue site, and then use its tip to guide through the small hole. The anchor head 17 is overall enlarged relative to the anchor core 18, and has an obvious sudden change in the radial direction. After the anchor head 17 is placed in the small hole formed by ablation, it will be limited and retained in the small hole to achieve positioning.

[0147] The anchoring head 17 may have various shapes. In one embodiment, the anchoring head 17 includes a cylindrical section 171 at the proximal end and a conical section 172 at the distal end; the third guide wire 113 passes through the cylindrical section 171 and is connected to the conical section 172 .

[0148] In actual working process, the conical section 172 and the cylindrical section 171 work together to form an anchoring point. During the anchoring process with the anchoring point, the conical surface of the conical section 172 can form a guiding effect to facilitate positioning; the cylindrical section 171 can play an anti-slip effect and keep the anchoring head 17 in the anchoring point, thereby providing a stable anchoring effect for the electrosurgical device.

[0149] In one embodiment, the anchor head 17 is entirely made of conductive material, namely, serves as a conductive portion.

[0150] Conductive materials can achieve the working effect of electrodes and release radio frequency energy to human tissue. In a specific design, the anchor head 17 may not be entirely made of conductive materials. For example, the outer surface may be made of conductive materials for releasing electromagnetic energy, and the interior may be made of other materials for achieving other functions. The specific materials may be selected according to specific working conditions.

[0151] The third wire 113 can be inserted into the sheath tube 11 during the insertion process. The advantage of this solution is that it is easy to produce. However, the sheath tube 11 itself can move relative to the anchor core 18, so the sheath tube 11 may wear the third wire 113.

[0152] In one embodiment, the anchoring core 18 is tubular, and the interior of the tube is a threading channel for the third wire 113;

[0153] A first mounting groove 173 is provided on the proximal side of the anchoring head 17. The distal end of the anchoring core 18 is inserted and fixed in the first mounting groove 173, and there is a sudden change in the radial dimension between the proximal end of the anchoring head 17 and the anchoring core 18.

[0154] The outer peripheral surface of the anchoring core 18 is used to guide the movement of the sheath tube 11, and the interior is used to thread the third wire 113. In fact, there are various ways to arrange the third wire 113. It can move freely inside the anchoring core 18, or be fixed inside the anchoring core 18, or be threaded through the tube wall of the anchoring core 18, and so on. The anchoring core 18 can provide protection for the third wire 113 to prevent impurities such as gas, liquid, and solid in the outside world from affecting the function of the third wire 113. The third wire 113 can be a composite structure with an insulating material on the outer layer and a conductive material on the inner layer, or a single conductive material, because the anchoring core 18 itself can provide shielding and protection for the third wire 113. The sudden change in the radial dimension between the anchoring head 17 and the anchoring core 18 is beneficial to tissue interception and positioning of the anchoring head 17.

[0155] In one embodiment, a second mounting groove 174 is provided at the bottom of the first mounting groove 173, and the distal end of the third wire 113 is welded and fixed in the second mounting groove 174.

[0156] In this embodiment, the welding referred to is a stable electrical connection, and there are various specific implementation forms. For example, the electrical connection and physical fixation are achieved through a third-party welding medium; for another example, the electrical connection and physical fixation are achieved through partial melting of the conductive material of the third wire 113 or the anchoring head 17. This connection and fixation method needs to meet three conditions: one is a stable electrical connection that can deliver radiofrequency energy to the anchoring head 17; the second is a relatively high-strength physical connection that does not easily fail when the anchoring head 17 is subjected to external forces; the third is relatively high inertness and does not react with other substances. When in the human body, this position is exposed to the internal environment of the human body. If there are multiple metal materials at the welding position, plus the current and humid environment, electrochemical reactions are likely to occur. Therefore, the inertness of the material also needs to be considered.

[0157] During the use of the electrotome device, there may be various usage methods according to different conditions of the lesion. Therefore, a modular design is adopted, which can be more flexibly combined according to different conditions to achieve functions. In one embodiment, an anchoring head control handle 181 is installed at the proximal end of the anchoring core 18, and a third wiring terminal 182 is installed on the anchoring head control handle 181. The proximal end of the third wire 113 is electrically connected to the third wiring terminal 182.

[0158] The third terminal 182 can provide a standard interface for the anchoring head 17, facilitating the production and use of supporting devices.

[0159] Reference Figures 13 to 17 , in one embodiment, the electrosurgical device includes a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a cylindrical structure. The distal side in the axial direction of the first electrode 13 is the cutting working part 131, and the proximal side in the axial direction of the first electrode 13 is a connecting part 132 fixed to the sheath 11.

[0160] The electrosurgical device further includes a cold anchoring head 19 and a delivery tube 20 for delivering a cooling medium to the cold anchoring head 19 to adjust the temperature of the cold anchoring head 19; in the use state, a threading path is defined. The sheath 11 is slidably sleeved on the delivery tube 20 and can move distally along the threading path.

[0161] The function of the delivery tube 20 is to define the threading path with its own axis, thereby guiding the movement of the sheath 11. At the same time, since the first electrode 13 and other components are fixed on the sheath 11, the movement of the first electrode 13 and other components on the threading path can be realized. This design is mainly to overcome the positioning problem of the first electrode 13. In the interventional field, how to accurately position the treatment device near the target tissue for treatment and adjust the spatial state during the treatment process has always been a difficult problem. The cold anchoring head 19 can form an anchor point on the human tissue through temperature change before the start of the treatment process, thus facilitating the adjustment of the spatial position or state of the internal components of the human body in cooperation with the proximal adjustment.

[0162] In one embodiment, the cold anchoring head 19 has an internal heat exchange cavity 191, and the delivery tube 20 communicates with the heat exchange cavity 191.

[0163] The delivery tube 20 realizes the stable adjustment of the cold anchoring head 19 by delivering a cooling medium to the heat exchange cavity 191. When there is more cooling medium, the temperature of the cold anchoring head 19 is lower. When it drops to a certain temperature, the cold anchoring head 19 can be anchored to the human tissue; when there is less cooling medium, the temperature of the cold anchoring head 19 rises under the influence of the human tissue temperature. When it rises above a certain temperature, the cold anchoring head 19 disengages from the human tissue.

[0164] In principle, the cold anchoring head 19 is made of a material with good thermal conductivity, which is convenient for adjusting the temperature of the cold anchoring head 19 through the cooling medium, so as to realize the conversion between anchoring and disengagement. In one embodiment, the heat exchange cavity 191 opens on the proximal side of the cold anchoring head 19, and the delivery tube 20 is docked at this opening part.

[0165] Specifically, there are also certain requirements for the contact area between the cold anchoring head 19 and the human tissue. Sufficient contact area is required to achieve a better anchoring effect.

[0166] In one embodiment, the delivery tube 20 is sleeved and fixed on the proximal side of the cold anchor head 19 .

[0167] The sleeve connection method is easy to install, but the strength and sealing of the connection need to be ensured. The cooling medium may affect human tissue and should be sealed inside the cold anchor head 19 as much as possible. At the same time, the diameter of the delivery pipe 20 also has certain requirements for delivering enough cooling medium to the cold anchor head 19.

[0168] In one embodiment, the cold anchor head 19 is cylindrical and has a closed distal end. The interior of the cylinder is a heat exchange chamber 191 , and the delivery pipe 20 is connected to the proximal end of the cylinder.

[0169] The cold anchor head 19 is generally in the shape of a cylinder with one end open. The advantage of the cylinder is that the cooling medium can fill the entire heat exchange chamber 191, thereby improving the heat exchange efficiency and thus improving the anchoring efficiency of the cold anchor head 19. At the same time, the outer peripheral surface area of ​​the cylinder is large, which can form a larger contact area with human tissue, thereby ensuring the anchoring effect.

[0170] During the anchoring process, the temperature of the cold anchor head 19 changes dramatically, and after anchoring, it may exert a pulling force on human tissue. In one embodiment, the cold anchor head 19 has a first working surface 192 facing the distal end and a second working surface 193 at the cylindrical periphery, and each working surface has a smooth surface.

[0171] The smooth surface can reduce the damage to human tissue. The first working surface 192 and the second working surface 193 can be used separately in different situations, reducing the positioning accuracy requirements of the cold anchor head 19 on human tissue.

[0172] The arrangement of the delivery pipe 20 is mainly used to deliver the cooling medium and form a passage for the cooling medium to go back and forth. Therefore, the delivery pipe 20 is actually selected to include at least two passages, one for going back and forth, to reduce the congestion of the cooling medium and the interference between the cooling medium before and after the work. Specifically, a pipe can be selected to be partitioned in the middle to form two independent passages, but the production cost of this design is high, and as the delivery pipe 20 is bent, one passage may be blocked.

[0173] In one embodiment, the delivery pipe 20 includes an outer pipe 22 and an inner pipe 21 which are nested, a first passage is provided in the inner pipe 21, and a second passage is provided in the gap between the outer pipe 22 and the inner pipe 21;

[0174] The first channel and the second channel intersect and communicate in the heat exchange chamber 191;

[0175] The first channel, the second channel and the heat exchange chamber 191 form a cooling medium circuit.

[0176] Because human tissues have the characteristic of constant temperature, sufficient cooling medium needs to be continuously input into the cold anchor head 19 during the anchoring process to ensure the anchoring effect. Therefore, the cooling medium circuit can ensure the smooth flow of the cooling medium and avoid the situation of anchoring failure caused by circuit congestion. In specific selection, when the new cooling medium enters the heat exchange cavity 191, it should be as close as possible to the side wall of the heat exchange cavity 191 to take away the heat of the cold anchor head 19, and the cooling medium that has absorbed the heat of the heat exchange cavity 191 leaves the heat exchange cavity 191 to make way for the new cooling medium.

[0177] In one embodiment, the outer tube 22 is hermetically sleeved on the proximal side of the cold anchor head 19, and the end of the inner tube 21 extends into the heat exchange cavity 191.

[0178] The hermetic sleeve of the outer tube 22 is beneficial to enclose the cooling medium in the cold anchor head 19 and reduce the influence of the cooling medium on human tissues. The end of the inner tube 21 extends into the heat exchange cavity 191, which can form a stable cooling medium passage in the heat exchange cavity 191, improve the stability of the cooling medium flow, and thus improve the anchoring effect of the cold anchor head 19.

[0179] The outer tube 22 needs to be hermetically connected to the cold anchor head 19. Among common technical means, the plug-in form with a large mouth on one side and a small mouth on the other side can ensure the effectiveness of the seal.

[0180] In one embodiment, the outer peripheral surfaces of the docking parts of the outer tube 22 and the cold anchor head 19 are flush with each other.

[0181] The outer tube 22 constitutes the threading path of the actual forming sheath tube 11. The sheath tube 11 moves circumferentially along the outer peripheral surface of the outer tube 22. Therefore, in some cases, a part of the sheath tube 11 may move to the part of the cold anchor head 19. At this time, the flush outer peripheral surfaces of the outer tube 22 and the cold anchor head 19 will not interfere with the movement of the sheath tube 11, thereby expanding the applicable range of the electrotome device. More importantly, the outer tube 22 with a flush outer peripheral surface and the cold anchor head 19 are not easily affected by external forces, thereby improving the stability of the hermetic connection and reducing the possibility of leaking cooling medium.

[0182] The specific shape of the inner tube 21 can affect the flow direction and flow rate of the cooling medium. In specific selection, the distal side of the inner tube 21 can be selected as a bevel cut shape with a straight cross-section, or an irregular groove with a continuously changing curve cross-section; various shapes such as a flat mouth can also be selected.

[0183] In one embodiment, the distal end of the inner tube 21 is a groove structure 211.

[0184] The groove structure 211 can specifically refer to the inconsistent axial lengths at both ends in the diameter direction of the inner tube 21. This design can control the flow direction and velocity of the cooling medium. In actual operation, the outer tube 22 sleeved outside the inner tube 21 provides a cooling medium passage around the outer peripheral surface of the inner tube 21. However, since the distal end of the inner tube 21 is a groove, part of the cooling medium will first pass through the inner tube 21, and the other part of the cooling medium needs to travel a longer distance to pass through the inner tube 21. Therefore, the groove structure 211 can achieve the control of the flow direction and velocity of the cooling medium.

[0185] The outer tube 22 and the inner tube 21 enable the cooling medium to enter and exit the heat exchange cavity 191. Therefore, the outer tube 22 and the inner tube 21 need to be connected to external devices respectively to achieve the stable circulation of the cooling medium. This is relatively inconvenient.

[0186] In one embodiment, a cold anchor control handle 23 is installed at the proximal end of the delivery tube 20. The cold anchor control handle 23 includes a housing 231. Two mutually isolated transfer cavities 232 are defined inside the housing 231, and each transfer cavity 232 is also connected to a connector 233 for docking with an external pipeline.

[0187] The external cooling medium delivery source is connected to the inner tube 21 and the outer tube 22 through the cold anchor control handle 23 at the proximal end, and the flow direction of the cooling medium is controlled through the isolated transfer cavities 232. The structure is simple and stable, which is convenient for operators such as medical staff to connect, control, and operate on-site, improving the convenience of the overall electrosurgical knife device.

[0188] In one embodiment, each transfer cavity 232 is directly opened inside the housing 231, or a transfer member 230 is provided inside the housing 231, and each transfer cavity 232 is opened inside the transfer member 230.

[0189] The main function of the transfer cavity 232 is to direct the cooling medium into different pipe bodies. The main advantage of this design is that it can stably control the characteristics such as the flow velocity and flow direction of the cooling medium, so as to provide stable cooling medium for the cold anchor 19 and optimize the anchoring effect. The transfer member 230 can enable the separate manufacturing of the cold anchor control handle 23 and the delivery tube 20, and then the transfer member 230 can be assembled into the cold anchor control handle 23 later, greatly reducing the production cost and processing requirements.

[0190] In implementing this embodiment, the cold anchor handle 23 can be a semi-open wrapping adapter 230 or a fully enclosed receiving adapter 230. When there are many enclosed components, in order to facilitate the connection between external devices and the adapter 230, the cold anchor handle 23 is provided with an adapter through-hole 235 in this embodiment. The adapter 230 penetrates the adapter through-hole 235 from the inside to the outside and is connected to the external device. The adapter through-hole 235 can also provide a limit for the adapter 230 to prevent circumferential self-rotation and axial displacement, improving the installation stability of the adapter 230 and the cold anchor handle 23.

[0191] Regarding the setting of the delivery pipe 20, it is mainly used to deliver the cooling medium to form a path for the back-and-forth flow of the cooling medium. Therefore, in actual selection, the delivery pipe 20 includes at least two one-way and one-return paths to reduce the congestion of the cooling medium and the interference between the cooling media before and after work. Specifically, a pipeline can be selected and partitioned in the middle to form two independent paths, but this design has a high production cost, and with the bending of the delivery pipe 20, one path may be blocked.

[0192] In one embodiment, the delivery pipe 20 includes an outer pipe 22 and an inner pipe 21 arranged in a nested manner, and the outer pipe 22 and the inner pipe 21 are respectively communicated with a corresponding transfer cavity 232.

[0193] The advantage of the mutual nesting of the outer pipe 22 and the inner pipe 21 is that it can reduce the change in the inner diameter of the pipe body when the pipe body is bent. When the mutually nested inner pipe 21 and outer pipe 22 are bent, the gap between the inner pipe 21 and the outer pipe 22 will become smaller on the side facing the bend and larger on the side facing away from the bend, so that the gap between the inner pipe 21 and the outer pipe 22 remains at a relatively stable level during the bending process, thus ensuring the flow of the cooling medium and optimizing the anchoring effect.

[0194] In the specific design, the two transfer cavities 232 can be independently designed, but this design will cause waste of the internal space of the cold anchor handle 23 and is also not conducive to the layout of the delivery pipe 20.

[0195] In one embodiment, there is a part of a common cavity wall 234 between the two transfer cavities 232. The outer pipe 22 and the inner pipe 21 penetrate into one of the transfer cavities 232, and only the inner pipe 21 passes through the common cavity wall 234 and enters the other transfer cavity 232.

[0196] In actual selection, the two transfer cavities 232 are arranged side by side in the axial direction of the inner pipe 21 and the outer pipe 22. By opening the pipe bodies in the corresponding transfer cavities 232 to achieve communication, the volume of the cold anchor handle 23 can be well reduced, multiple paths can be established within small components, and it is convenient for operators such as medical staff to operate. In the specific implementation, when the inner pipe 21 passes through the common cavity wall 234, it needs to be sealed with the common cavity wall 234 to achieve the independence of the two transfer cavities 232.

[0197] In order to fix the position of the outer tube 22 and the inner tube 21 relative to the adapter cavity 232, a fixed structure is required. For example, a fixed component can be used to lock the axial position of the outer tube 22 and the inner tube 21 to prevent the axial position of the outer tube 22 and the inner tube 21 from changing due to external force during treatment, resulting in failure of the cooling medium circuit and anchoring.

[0198] In one embodiment, the outer tube 22 and the inner tube 21 are respectively fixed to the cavity walls of the corresponding parts of the transition cavity 232, so that the outer tube 22 and the inner tube 21 maintain a relative axial position.

[0199] The passage of the cooling medium is realized by the outer tube 22 and the inner tube 21 accurately opening in the corresponding transfer cavity 232, so the axial position of the outer tube 22 and the inner tube 21 determines the stability of the cooling medium circuit. Compared with other designs, this design has the advantage of simple structure, eliminating independent fixing components, and making the production and assembly of the cold anchor head control handle 23 more convenient.

[0200] refer to Figures 18 to 20 In one embodiment, the electrosurgical device includes a sheath 11, a handle 12 connected to the proximal end of the sheath 11, and a first electrode 13 connected to the distal end of the sheath 11. The first electrode 13 is a cylindrical structure, the axial distal end side of the first electrode 13 is a cutting working part 131, and the axial proximal end side of the first electrode 13 is a connecting part 132 fixed to the sheath 11. The electrosurgical device also includes a cold anchor head 19 and a delivery tube 20 for delivering a cooling medium to the cold anchor head 19 to adjust the temperature of the cold anchor head 19; in the use state, the delivery tube 20 defines a threading path, and the sheath 11 is slidably sleeved on the delivery tube 20 and can move toward the distal end along the threading path.

[0201] A traction wire 24 is also passed through the delivery tube 20, and the distal end of the traction wire 24 is connected to the cold anchor head 19 to adjust the posture of the cold anchor head 19; a cold anchor head control handle 23 is installed at the proximal end of the delivery tube 20, and a control component 25 that is linked to the proximal end of the traction wire 24 is provided on the cold anchor head control handle 23.

[0202] The traction wire 24 is used to apply tension to the cold anchor head 19. When the cold anchor head 19 is located in the human body, the tension of the traction wire 24 will produce a twisting movement tendency, thereby adjusting the spatial position state of the cold anchor head 19. The adjustment of the spatial position state of the cold anchor head 19 can achieve a more flexible and more precise anchoring effect, thereby providing a more flexible insertion path for the sheath 11 and improving the overall effect of the electrosurgical device.

[0203] The traction wire 24 needs to transmit the force to the cold anchor head 19 to achieve the bending adjustment function. Specifically, a clamping component can be set on the cold anchor head 19 or a direct connection method can be selected to achieve fixation.

[0204] In one embodiment, the distal end of the traction wire 24 is fixedly welded to the outer wall of the cold anchor head 19.

[0205] The welding in this embodiment refers to a physical connection with relatively high strength. The traction wire 24 is used to apply a force to drive the cold anchor head 19 to twist, and the transmission needs to be achieved through welding. Fixing to the outer wall of the cold anchor head 19 can increase the lever arm of the torsion force generated by the traction wire 24 on the cold anchor head 19, facilitating the operation of operators such as medical staff. In a specific design, in order to facilitate the connection between the traction wire 24 and the cold anchor head 19, a traction groove 221 is provided on the cold anchor head 19. A plurality of traction grooves 221 are provided in the circumferential direction of the cold anchor head 19 to correspond to the positions of the traction wires 24 in different products. The design of the traction groove 221 enables the cold anchor head 19 after the installation of the traction wire 24 to still achieve a sealed connection with the delivery tube 20.

[0206] In one embodiment, the cold anchor head control handle 23 includes a housing 231, and a control component 25 is slidably or rotatably installed on the housing 231. A locking member 251 for maintaining their relative positions is further provided between the housing 231 and the control component 25.

[0207] The control component 25 changes the relative position relationship between the traction wire 24 and the housing 231 by sliding or rotating, so as to apply a traction force to the cold anchor head 19 to adjust the spatial position of the cold anchor head 19. In the design of the specific structure, a structure convenient for single-handed operation is generally provided. For example, when the control component 25 is slidably installed, the operator only needs to hold the housing 231 with one hand and drive the control component 25 to slide with a finger to drive the traction wire 24; for another example, when the control component 25 is rotatably installed, the operator only needs to hold the housing 231 with one hand and turn the control component 25 with a finger to drive the traction wire 24; this design greatly facilitates the operation process of the operator.

[0208] In one embodiment, two mutually isolated transfer cavities 232 are defined in the housing 231. The delivery tube 20 includes an outer tube 22 and an inner tube 21 which are nested, and the outer tube 22 and the inner tube 21 are respectively communicated with a corresponding transfer cavity 232; an extension channel 242 is formed in the side wall of the outer tube 22, and the traction wire 24 is threaded through the extension channel 242.

[0209] An external cooling medium delivery source is connected to the inner tube 21 and the outer tube 22 through the proximal cold anchor head control handle 23, and the flow direction of the cooling medium is controlled through the isolated transfer cavities 232. The structure is simple and stable, which is beneficial to improving the stability of the overall electrocautery device. The traction wire 24 is threaded through the extension channel 242 in the side wall of the outer tube 22 and can displace relative to the outer tube 22. The outer tube 22 can provide protection for the traction wire 24 to prevent external impurities from affecting the movement of the traction wire 24.

[0210] In one embodiment, a guiding groove 2311 is formed in the housing 231, and the control member 25 is a toggle button that moves along the guiding groove 2311. The design of the toggle button facilitates directly transmitting the force applied by the operator to the traction wire 24, and enables the operator to operate the control member 25 with one hand without the need for other components.

[0211] In the specific design of this embodiment, the control member 25 includes:

[0212] An operating part 252, which is exposed outside the housing 231 of the cold anchor head control handle 23;

[0213] A traction part 253, which is accommodated in the housing 231 of the cold anchor head control handle 23 and is connected to the traction wire 24 through a traction wire head 241;

[0214] A transmission member 254, which is slidably fitted in the guiding groove 2311 and is respectively connected to the operating part 252 and the traction part 253 at both ends.

[0215] In a further preferred embodiment, the traction part 253 is further provided with a first receiving cavity 2531, the traction wire head 241 is fixed in the first receiving cavity 2531, and the traction wire 24 passes through the side wall of the first receiving cavity 2531 of the traction part 253 through a traction wire through hole 2533. When an operator such as a medical staff operates the control member 25, first unlock the locking member 251, and then apply a force to the operating part 252. Under the guidance of the guiding groove 2311, the force can drive the transmission member 254 to move along the guiding groove 2311, thereby driving the traction part 253 to move. When the traction part 253 moves, a force is applied to the traction wire head 241 through the side wall of the first receiving cavity 2531, thereby driving the traction wire 24 to act and completing the bending adjustment process.

[0216] In one embodiment, the locking member 251 is a compression spring that is pressed between the housing 231 and the control member 25, and the relative positions of the housing 231 and the control member 25 are maintained by the tension provided by the compression spring. In the specific design of this embodiment, the locking member 251, i.e., the compression spring, can be arranged between the traction part 253 and the transmission member 254, and the friction force between the transmission member 254 and the housing 231 of the cold anchor head control handle 23 is increased by pressing, so as to realize the locking of the control member 25 by the locking member 251.

[0217] In a further preference, the traction part 253 is provided with a second receiving cavity 2532 for receiving the locking member 251. The shape of the second receiving cavity 2532 is complementary to that of the transmission member 254, and can play a role in guiding the transmission member 254 away from or close to the traction part 253, thereby improving the working stability of the locking member 251.

[0218] In a further preference, a pressing plate 2541 with a relatively large area is further provided on one side of the transmission member 254 facing the locking member 251, and the shape of the second receiving cavity 2532 is complementary to that of the pressing plate 2541, which can effectively improve the working stability of the locking member 251.

[0219] During the unlocking process, operators such as medical staff only need to apply a driving force along the circumferential direction of the transmission member 254 through the operation part 252. This driving force will overcome the elastic force of the locking member 251 and thus drive the traction part 253 and the transmission member 254 to approach each other. At this time, the transmission member 254 and the housing 231 of the cold anchor control handle 23 move away from each other, and operators such as medical staff can realize the free movement of the control component 25.

[0220] The tension force of the compression spring can maintain the relative position between the housing 231 and the control component 25, and at the same time does not affect the direct operation of the operator, simplifies the unlocking and locking steps, and is convenient for the operator to accurately control the cold anchor 19. In this embodiment, the compression spring can be replaced by other elastic members in actual design, such as deformable rubber blocks, etc.

[0221] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of concise description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification. When the technical features in different embodiments are shown in the same drawing, it can be regarded that the drawing also discloses the combination examples of the respective embodiments involved at the same time.

[0222] The above-described embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent should be subject to the appended claims.

Claims

1. An electrosurgical device, comprising 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, characterized in that, The first electrode is a cylindrical structure, the distal end of the first electrode is a cutting working part, and the proximal end of the first electrode is a connecting part fixed to the sheath tube; The electrosurgical device further comprises: A cold anchor head, wherein the cold anchor head has a heat exchange chamber inside; A delivery tube is connected to the heat exchange chamber and is used to deliver cooling medium to the cold anchor head to adjust the temperature of the cold anchor head. The delivery tube defines a threading path. The sheath tube is slidably mounted on the delivery tube and can move toward the distal end along the threading path. The distal end of the sheath tube can move to the outer periphery of the cold anchor head. A traction wire is also passed through the delivery tube. The distal end of the traction wire is connected to the cold anchor head to adjust the posture of the cold anchor head. The cold anchor head is provided with a traction groove, and the traction wire is connected to the traction groove.

2. The electrosurgical device according to claim 1, characterized in that, The heat exchange chamber opens at the proximal end of the cold anchor head, and the delivery pipe is butted against the opening.

3. The electrosurgical device according to claim 2, characterized in that, The delivery tube is sleeved and fixed on the proximal end side of the cold anchor head.

4. The electrocautery device according to claim 1, wherein The cold anchor head is cylindrical and has a closed distal end. The interior of the cylinder is the heat exchange chamber. The delivery pipe is butt-connected to the proximal end of the cylinder.

5. The electrosurgical knife device according to claim 4, wherein, The cold anchor head has a first working surface facing the distal end and a second working surface located at the outer periphery of the cylinder, and the surface of each working surface is smooth.

6. The electrosurgical knife device according to claim 1, characterized in that The delivery pipe comprises an outer pipe and an inner pipe which are nested, a first passage is provided in the inner pipe, and a second passage is provided in the gap between the outer pipe and the inner pipe; The first channel and the second channel intersect and communicate with each other in the heat exchange chamber; The first channel, the second channel and the heat exchange chamber form a cooling medium circuit.

7. The electrosurgical device according to claim 6, characterized in that, The outer tube sealing sleeve is arranged on the proximal side of the cold anchor head, and the end of the inner tube extends into the heat exchange cavity.

8. The electrosurgical knife device according to claim 6, wherein, The outer peripheral surfaces of the joints between the outer tube and the cold anchor head are flush with each other.

9. The electrosurgical device according to claim 6, wherein The distal end of the inner tube is a groove structure.

10. The electrosurgical device according to claim 1, characterized in that, A cold anchor head control handle is installed at the proximal end of the delivery tube. The cold anchor head control handle includes a shell. Two mutually isolated transfer chambers are defined in the shell. Each transfer chamber is also connected to a transfer joint for connecting to an external pipeline.

11. The electrosurgical knife device according to claim 10, characterized in that, The adapter cavities are directly opened in the shell, or an adapter is provided in the shell, and the adapter cavities are opened in the adapter.

12. The electrosurgical device according to claim 10, wherein, The delivery pipe comprises an outer pipe and an inner pipe which are nested and are respectively connected to a corresponding transfer cavity.

13. The electrosurgical knife device according to claim 12, characterized in that, A portion of a common cavity wall is provided between the two transition cavities, the outer tube and the inner tube penetrate into one of the transition cavities, and only the inner tube passes through the common cavity wall and enters into the other transition cavity.

14. The electrosurgical device according to claim 12, characterized in that, The outer tube and the inner tube are respectively fixed to the cavity walls of the corresponding parts of the transition cavity, so that the outer tube and the inner tube maintain a relative axial position.

15. The electrosurgical knife device according to claim 1, wherein, A cold anchor head control handle is installed at the proximal end of the delivery tube, and a control component that is linked to the proximal end of the traction wire is provided on the cold anchor head control handle.

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