Ablation device and method of manufacturing an ablation device

Abstract

The application relates to the technical field of medical products, and discloses an ablation device and a manufacturing method of the ablation device. The ablation device comprises a tube body assembly, an ablation assembly and a handle assembly. The tube body assembly comprises a main tube and a push-pull tube. The main tube is provided with a first cavity along the axial direction of the main tube. The push-pull tube is movably arranged in the first cavity. The proximal end of the ablation assembly is connected to the distal end of the main tube. The distal end of the push-pull tube is drivingly connected to the distal end of the ablation assembly. The handle assembly comprises a shell part, an adjusting module and a first tube. The proximal end of the push-pull tube is located in the shell part. The first tube is sleeved and connected to the proximal end of the push-pull tube. The adjusting module is drivingly connected to the first tube. The adjusting module is used for driving the first tube to move along the axial direction of the first tube, so that the push-pull tube is driven to move, and the ablation assembly is switched between an expanded state and a contracted state. The degree of bending deformation of the part of the push-pull tube located in the handle is reduced, the adjusting precision is improved, and the consistency and reliability of the ablation effect are improved.

Description

Technical Field

[0001] This application relates to the field of medical product technology, and in particular to an ablation device and a method for manufacturing the ablation device. Background Technology

[0002] Pulse field ablation (PFA), as a novel non-thermal ablation technique, has shown significant advantages in the treatment of arrhythmias such as atrial fibrillation in recent years. With the continuous development of PFA technology, its pulse ablation morphology has become increasingly diversified. To meet the functional requirements of different surgical procedures and diverse ablation styles, the corresponding handpiece design and ablation system have also presented different functional forms.

[0003] In related technologies, an adjustment mechanism drives a push-pull tube to reciprocate axially, thereby expanding and contracting the ablation component to complete ablation operations of different forms. However, during operation, it was found that when driving the push-pull tube, the expansion trajectory of the ablation mechanism deviates from the expected path due to the bending and deformation of the push-pull tube located in the handle, resulting in a reduced ablation effect. Summary of the Invention

[0004] In one embodiment, this application provides an ablation device, comprising: The tube assembly includes a main tube and a push-pull tube, wherein the main tube has a first cavity along its own axial direction, and the push-pull tube is movably inserted into the first cavity; An ablation assembly, wherein the proximal end of the ablation assembly is connected to the distal end of the main tube, and the distal end of the push-pull tube is tractively connected to the distal end of the ablation assembly; The handle assembly includes a housing component, an adjustment module, and a first tube. The proximal end of the push-pull tube is located inside the housing component. The first tube is sleeved and connected to the proximal end of the push-pull tube. The adjustment module is throttle-connected to the first tube. The adjustment module is used to drive the first tube to reciprocate along its own axis, thereby moving the push-pull tube and switching the ablation component between an expanded state and a contracted state.

[0005] In one embodiment, the hardness of the first tube is greater than the hardness of the push-pull tube.

[0006] In one embodiment, the adjustment module includes a push knob and a connecting component, the connecting component connecting the first tube and the push knob; the push knob is at least partially disposed outside the housing component.

[0007] In one embodiment, the connecting component includes a bracket and a base, the push-button is connected to the bracket, the bracket is detachably connected to the base, and together they define a first through hole extending axially, the first tube passing through the first through hole and connected to the inner wall of the first through hole.

[0008] In one embodiment, the outer wall of the housing component is provided with an elongated hole, the push knob is configured to move along the extension direction of the elongated hole, and the adjustment module is spaced apart from the inner wall of the elongated hole in its own width direction.

[0009] In one embodiment, the main tube has a second cavity along its own axial direction, and the handle assembly has a receiving cavity; The ablation assembly includes an ablation element and a wire. The wire passes through the second cavity and is electrically connected at its distal end to the ablation element. The wire has a buffer portion housed in the receiving cavity. The buffer portion has a first buffer point and a second buffer point, which are spaced apart along the axial direction of the wire. The buffer portion is configured to be in a relaxed state when the tube assembly is bent, and the first buffer point is movable relative to the second buffer point when the tube assembly is bent.

[0010] In one embodiment, the handle assembly further includes a wire guide connector disposed within the housing component, the wire guide connector having the receiving cavity and a wire guide hole communicating with the receiving cavity, the push-pull tube being movably inserted through the receiving cavity, and the wire being inserted through the wire guide hole and the receiving cavity.

[0011] In one embodiment, the ablation assembly includes a plurality of lead wire groups, each of the lead wire groups including at least one lead wire; The wire connector has multiple wire holes, which are spaced apart circumferentially along the wire connector, and each wire group is individually threaded through one wire hole.

[0012] In one embodiment, the cable connector includes a proximal wall, a peripheral wall, and an extension tube. The proximal wall is connected to the proximal end of the peripheral wall and together defines the receiving cavity. The outer diameter of the extension tube is smaller than the inner diameter of the receiving cavity. The extension tube is connected to the proximal wall and protrudes toward the receiving cavity. The extension tube has a third cavity communicating with the receiving cavity, and the first tube is movably inserted through the third cavity. The extension tube and the wire-passing hole are spaced apart on the projection plane perpendicular to the central axis of the wire-passing connector.

[0013] In one embodiment, the distal end of the first tube is located within the third cavity, and the ablation device is configured such that the length of the third cavity is greater than the travel distance of the first tube.

[0014] In one embodiment, the length of the wire along its own axis within the receiving cavity is a, the length of the receiving cavity along its own axis is b, ab = c, and 3mm ≤ c ≤ 40mm.

[0015] In one implementation, 5mm ≤ c ≤ 20mm.

[0016] In one embodiment, the ablation assembly includes a plurality of the wires, the main tube has a plurality of second cavities, the plurality of second cavities are circumferentially spaced along the first cavity, the wire connector has a plurality of wire holes, the plurality of wire holes are circumferentially spaced along the third cavity, each wire hole has at least one wire inserted through it, and the portion of the plurality of wires near the proximal end of the wire connector is bundled into a wire bundle.

[0017] In one embodiment, each of the wire holes corresponds to at least one second cavity.

[0018] In one embodiment, each of the wire holes corresponds to two second cavities.

[0019] In one embodiment, at least one of the wires passes through a second cavity and a corresponding wire hole of the second cavity.

[0020] In one embodiment, the wire hole is sealed to the wire.

[0021] In one embodiment, the handle assembly further includes an injection module disposed within the housing component, wherein the first tube passes through the injection module and is connected to the adjustment module; The injection module includes a water supply pipe with a first flow channel connected to the second cavity. The portion of the wire near the wire connector and the water supply pipe are located on the radial sides of the push-pull tube, respectively.

[0022] In one embodiment, the infusion module further includes a water tank component and a second pipe. The water tank component is provided with a receiving cavity, and the water supply pipe is connected to the receiving cavity. A second through hole is opened at the distal end of the receiving cavity, and a third through hole is opened at the proximal end of the receiving cavity. One end of the second pipe is inserted into the proximal end of the third cavity, and the other end is inserted into the second through hole. The first pipe is slidably inserted from the distal end to the proximal end through the third cavity, the second pipe, the receiving cavity, and the third through hole. An infusion gap communicating with the second cavity is defined between the first pipe and the inner wall of the third cavity, and between the first pipe and the second pipe.

[0023] In one embodiment, the handle assembly further includes a tubular connector comprising a distal connector tube and a proximal connector tube, the distal connector tube having a first connection hole and the proximal connector tube having a second connection hole, the first connection hole communicating with the second connection hole, the main tube being inserted into the first connection hole, and the wire guide being inserted into the second connection hole.

[0024] In one embodiment, the injection module further includes a first sealing ring, which is sealed and sleeved on the outside of the first pipe and sealed to the inner wall of the third through hole.

[0025] In one embodiment, the injection module further includes a water pipe connector, and the water tank component also has a first insertion hole communicating with the receiving cavity, the first insertion hole extending to the radial sidewall of the water tank component, the water pipe connector being connected to the first insertion hole, the water pipe connector having a second insertion hole, and the water supply pipe being inserted into the second insertion hole.

[0026] In one embodiment, the water tank component includes a tank body and an end cap, the end cap being sealed to the tank body and defining the receiving cavity.

[0027] In one embodiment, the handle assembly further includes a flexible protective sleeve connected to the distal end of the housing component, with the main tube passing through the flexible protective sleeve.

[0028] In some embodiments, this application provides a method for manufacturing an ablation device, comprising at least the following steps: A tube assembly, an ablation assembly, and a handle assembly are provided; wherein, the ablation assembly includes a main tube and a push-pull tube, the main tube has a first cavity along its own axial direction, and the handle assembly includes a housing component, an adjustment module, and a first tube fitting; The push-pull tube is movably inserted into the first cavity; The proximal end of the ablation component is connected to the distal end of the main tube; The proximal end of the ablation component is connected to the distal end of the push-pull tube; The proximal end of the main tube is connected to the housing component; The proximal end of the push-pull tube is installed inside the housing component; The first fitting is sleeved onto the near end of the push-pull tube, and the first fitting is connected to the push-pull tube; The adjustment module is connected to the first tube, and the adjustment module can drive the first tube to reciprocate along its own axis to move the push-pull tube, so that the ablation component switches between an expanded state and a contracted state.

[0029] This application provides an ablation device and a method for manufacturing the ablation device in several embodiments. During use, when the adjustment module drives the first tube and the push-pull tube to move axially away from the ablation component, the ablation component switches to an expanded state; conversely, when the adjustment module drives the first tube and the push-pull tube to move axially closer to the ablation component, the ablation component switches to a contracted state, thus achieving state adjustment of the ablation component. This ablation device, by having the first tube sleeved and connected to the portion of the push-pull tube located within the housing component, allows the first tube to support the outer wall of the push-pull tube, improving the overall rigidity of the first tube and the push-pull tube, reducing the degree of bending deformation in the portion of the push-pull tube located inside the handle, improving adjustment accuracy, and enhancing the consistency and reliability of the ablation effect. Attached Figure Description

[0030] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments of this application will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of this application and these drawings without creative effort.

[0031] Figure 1 This is a schematic diagram of the ablation device provided in a specific embodiment of this application; Figure 2 This is an exploded view of the ablation device provided in the specific embodiments of this application; Figure 3 This is a partial structural cross-sectional view of the ablation device provided in the specific embodiments of this application; Figure 4 This is a cross-sectional view of the tube assembly provided in a specific embodiment of this application; Figure 5 This is one of the partial structural schematic diagrams of the ablation device provided in the specific embodiments of this application; Figure 6 This is a schematic diagram of the structure of the connecting component provided in a specific embodiment of this application; Figure 7 This is a schematic diagram of the handle assembly provided in a specific embodiment of this application; Figure 8 This is a schematic diagram of the wire connector provided in a specific embodiment of this application; Figure 9 This is a cross-sectional view of the cable connector provided in a specific embodiment of this application; Figure 10 This is a second partial structural schematic diagram of the ablation device provided in the specific embodiments of this application; Figure 11 This is an exploded view of the structure of the water tank component provided in the specific embodiments of this application; Figure 12 yes Figure 1 Enlarged view at point A.

[0032] The markings in the image are as follows: 1. Tube body assembly; 11. Main tube; 111. First cavity; 112. Second cavity; 12. Push-pull tube; 2. Ablation assembly; 21. Lead wire; 211. Buffer section; 22. Wire harness; 23. Connector; 24. Ablation component; 25. Distal cap; 3. Handle assembly; 31. Housing component; 311. Front shell; 312. Rear shell; 3121. Elongated hole; 32. Adjustment module; 321. Push knob; 322. Connecting component; 3221. Bracket; 3222. Base; 3223. First through hole; 33. First tube fitting; 34. Cable connector; 341. Receiving cavity; 342. Third cavity; 343. Cable hole; 344. Proximal wall; 345. Peripheral wall; 346. Extension tube; 35. Tube fitting connector; 351. Distal connector tube; 35 11. First connecting hole; 352. Proximal connector pipe; 3521. Second connecting hole; 36. Injection module; 361. Water supply pipe; 362. Water tank component; 3621. Tank body; 36211. First insertion hole; 36212. Second through hole; 3622. End cap; 36221. Third through hole; 3623. Receiving cavity; 363. Second fitting; 364. First sealing ring; 365. Water pipe connector; 3651. Second insertion hole; 366. Second sealing ring; 37. Flexible protective sleeve. Detailed Implementation

[0033] It should be understood that the examples and illustrations in this application are for illustrative purposes, and deviations and variations can be constructed and deployed based on the teachings of this application without departing from the scope of this application. Before detailing at least one embodiment of this application, it should be understood that this application is not necessarily limited to the detailed configuration and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. This application can have other embodiments or can be practiced or implemented in different ways.

[0034] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While similar or equivalent methods and materials to those described in this application may be used to practice or test embodiments of this application, exemplary methods and / or materials are described below. In the event of any conflict, the specification (including definitions) of this application shall prevail. Furthermore, these materials, methods, and embodiments are illustrative only and are not intended to impose necessary limitations.

[0035] In the description of this application, unless otherwise expressly specified and limited, the terms "set at," "contained in," "alongside," "connected," "fixed," "fixed to," and "fixed connection," etc., should be interpreted broadly. For example, they can refer to a non-removable fixed connection, a detachable fixed connection, or an integral part, except where there is a specific emphasis, such as a non-removable fixed connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. Furthermore, the terms "first," "second," etc., are used merely for descriptive distinction and have no special meaning.

[0036] In this application, the distal end refers to the end of the ablation device and at least some of the components constituting the ablation device that are exemplary remote from the operator during use (or, the distal end refers to the end of the ablation device and at least some of the components constituting the ablation device that are exemplary in contact with or intervene in the biological tissue when used on a living organism), and the proximal end refers to the end of the ablation device and at least some of the components constituting the catheter / ablation device that are exemplary close to the operator during operation (or, the proximal end refers to the end of the ablation device and at least some of the components constituting the ablation device that are exemplary in use on a living organism that are more remote from the biological tissue than the distal end).

[0037] like Figures 1-5As shown, at least one embodiment of this application provides an ablation device, including a tube assembly 1, an ablation component 2, and a handle assembly 3. The tube assembly 1 includes a main tube 11 and a push-pull tube 12. The main tube 11 has a first cavity 111 arranged along its own axial direction. The push-pull tube 12 is movably inserted through the first cavity 111. The proximal end of the ablation component 2 is connected to the distal end of the main tube 11, and the distal end of the push-pull tube 12 is throttle-connected to the distal end of the ablation component 2. The handle assembly 3 includes a housing component 31, an adjustment module 32, and a first tube 33. The proximal end of the push-pull tube 12 is located inside the housing component 31. The first tube 33 is sleeved and connected to the proximal end of the push-pull tube 12. The adjustment module 32 is throttle-connected to the first tube 33. The adjustment module 32 is used to drive the first tube 33 to reciprocate along its own axial direction, so as to drive the push-pull tube 12 to move, so that the ablation component 2 switches between an expanded state and a contracted state.

[0038] For example, such as Figure 1 and Figure 12 As shown, the ablation assembly 2 includes several connectors 23 and ablation elements 24 sleeved on the connectors 23. The ablation elements 24 are ablation electrodes. The connectors 23 are arranged circumferentially around the central axis of the ablation assembly 2. The distal ends of the connectors 23 converge and connect together. In the initial state, the distal ends of the connectors 23 have an open-loop structure to facilitate the placement of the ablation electrode on each connector 23. After the ablation electrode assembly is completed, the distal ends of the connectors 23 are connected to the distal end of the push-pull tube 12 through the distal end cap 25. At the same time, the proximal ends of the connectors 23 also converge and connect to the distal end of the main tube 11.

[0039] Each ablation electrode is connected to a corresponding wire 21. Several ablation electrodes are disposed on each connector 23. For example, two ablation electrodes are spaced apart along the axial direction on each connector 23. The ablation electrodes are annular electrodes, and in the multiple connectors 23, the multiple ablation electrodes correspond one-to-one along their axial directions. It is understood that the number of ablation electrodes can be reasonably set according to actual conditions, and the shape of the ablation electrodes can also be sheet-like, spherical, dot-like, or other shapes; this embodiment does not limit this. The ablation electrodes can be made of platinum-iridium alloy, gold alloy, stainless steel, nickel-titanium, or any other biocompatible medical metal.

[0040] In this embodiment, the connector 23 is a hollow sheet structure with an axial inner cavity for the ablation electrode wire 21 to pass through. A wire hole is provided at the location of the ablation electrode on the connector 23, communicating with the axial inner cavity. The distal end of the wire 21 passes through this wire hole and connects to the ablation electrode. After the distal end of the wire 21 is welded to the ablation electrode through the wire hole, the proximal end of the wire 21 enters the second cavity 112 of the main tube 11 through the axial inner cavity of the connector 23. After the wire 21 passes through the second cavity 112 of the main tube 11, the proximal ends of several connectors 23 are connected to the distal ends of the main tube 11 by heat fusion. It is understood that the connector 23 can be in other structural forms besides a sheet structure, such as circular or elliptical. Besides heat fusion, the proximal ends of several connectors 23 can also be connected to the distal ends of the main tube 11 by welding, adhesive bonding, etc. The number of connectors 23 can be four, six, eight, or other suitable numbers. In this embodiment, there are five connectors 23, five second cavities 112, and five wire holes 343. Two wires 21 pass through one wire hole 343, two second cavities 112, and one axial inner cavity and are electrically connected to two ablation electrodes. The connectors 23 can be evenly or non-uniformly distributed circumferentially.

[0041] In use, when the adjustment module 32 drives the first tube 33 and the push-pull tube 12 to move away from the ablation component 2 along the axial direction of the first tube 33, the ablation component 2 switches to an expanded state; conversely, when the adjustment module 32 drives the first tube 33 and the push-pull tube 12 to move closer to the ablation component 2 along the axial direction of the first tube 33, the ablation component 2 switches to a contracted state, thus achieving state adjustment of the ablation component 2. This ablation device, by fitting the first tube 33 onto and connecting it to the push-pull tube 12 within the housing component 31, allows the first tube 33 to support the outer wall of the push-pull tube 12, improving the overall rigidity of the first tube 33 and the push-pull tube 12, reducing the degree of bending deformation in the part of the push-pull tube 12 located inside the handle, improving adjustment accuracy, and enhancing the consistency and reliability of the ablation effect.

[0042] Furthermore, since the first tube 33 does not require bending within the handle assembly 3, in some embodiments, the hardness of the first tube 33 is greater than that of the push-pull tube 12. By increasing the hardness of the first tube 33, the overall rigidity of the first tube 33 and the push-pull tube 12 is further improved. The first tube 33 can be a stainless steel tube, a nickel-titanium alloy tube, or other high-rigidity metal tube, as long as its hardness is higher than that of the push-pull tube 12.

[0043] Furthermore, the adjustment module 32 includes a push knob 321 and a connecting component 322, the connecting component 322 connecting the first tube 33 and the push knob 321; the push knob 321 is at least partially disposed outside the housing component 31. In use, the operator can push the part of the push knob 321 located outside the housing component 31. The push knob 321 indirectly drives the first tube 33 and the push-pull tube 12 to move relative to the main tube 11 through the connecting component 322, causing the ablation component 2 to deform and change its radial dimension. If the push knob 321 moves proximally, it drives the push-pull tube 12 and the first tube 33 to move proximally relative to the main tube 11, increasing the radial dimension of the ablation component 2; if the push knob 321 moves distally, it drives the push-pull tube 12 to move distally relative to the main tube 11, decreasing the radial dimension of the ablation component 2. Specifically, in this embodiment, the linear displacement of the push-pull mechanism 321 is converted into the axial movement of the push-pull tube 12, eliminating the need for complex mechanisms to convert the motion form. This avoids complex structures such as rotational motion or gear transmission, simplifying the internal structure of the handle assembly 3, reducing processing difficulty and assembly costs, and also helping to reduce the overall size of the handle and improve grip comfort. Furthermore, the degree of deformation of the ablation component 2 can be intuitively perceived through the distance the fingers move, facilitating operator control of the diameter of the ablation component.

[0044] In one embodiment, such as Figure 6 As shown, the connecting component 322 includes a bracket 3221 and a base 3222. A push-button 321 is connected to the bracket 3221, and the bracket 3221 is detachably connected to the base 3222. Together, they define a first through hole 3223 extending axially. A first tube 33 passes through the first through hole 3223 and is connected to the inner wall of the first through hole 3223. The bracket 3221 and the push-button 321 engage with each other, and glue is injected at the engagement point to bond them together, thus connecting the bracket 3221 and the push-button 321. Of course, besides adhesive bonding, the push-button 321 and the bracket 3221 can also be connected using any other fixed connection structure, such as a threaded connection or a snap-fit ​​connection. After the first tube 33 passes through the first through hole 3223, glue can be injected into the first through hole 3223 to improve the connection strength between the first tube 33 and the connecting component 322. Of course, in other embodiments, the first tube 33 can also be connected to the connecting component 322 by any other fixing method besides the above-mentioned method, such as snap-fit ​​connection or interference fit between the first tube 33 and the first through hole 3223, etc. This application does not impose any restrictions.

[0045] like Figure 7As shown, the outer wall of the housing component 31 is provided with an elongated hole 3121, and the push knob 321 is configured to move along the extension direction of the elongated hole 3121. The adjustment module 32 is spaced apart from the inner wall of the elongated hole 3121 in its own width direction. The push knob 321 is restricted to move within the extension range of the elongated hole 3121, which can limit the maximum displacement of the push knob 321. Furthermore, there is no contact between the adjustment module 32 and the housing component 31, so there is no friction between the adjustment module 32 and the housing component 31, reducing the resistance of the push knob 321 and improving the ease of operation.

[0046] In this embodiment, the housing component 31 includes a front housing 311 and a rear housing 312 sequentially from the distal end to the proximal end. The connecting component 322 is located inside the rear housing 312. The elongated hole 3121 is provided on the side wall of the rear housing 312. The portion of the first tube 33 extending out of the first through hole 3223 is located at the proximal end inside the rear housing 312 and is connected to a tail tube. The tail tube is located outside the rear housing 312, and the proximal end of the tail tube is connected to a guide pin.

[0047] In the existing technology, the discharge wires of pulse ablation catheters are thin and long, making them extremely easy to bend during production and assembly. Furthermore, during the process of the catheter entering the human blood vessel and bending, the wires inside the catheter are excessively stretched due to bending. Bending changes the cross-sectional area of ​​the wires and the electron path, which has a significant impact on the inductance of high-frequency current. In addition, the heat dissipation capacity of the bent part decreases, leading to a sharp increase in local temperature, which can trigger breakdown discharge, thereby causing circuit breakage and product failure. During high-voltage discharge, sparks may also be generated in the bent area, causing the wires to break and the circuit to open.

[0048] It is understandable that when the catheter is bent, the lead wire 21 located on the outside of the bend will be subjected to a certain tensile stress. Based on this, in some embodiments, the main tube 11 is provided with a second cavity 112 along its own axial direction, and the handle assembly 3 has a receiving cavity 341; the ablation assembly 2 includes an ablation element 24 and a lead wire 21, the lead wire 21 passes through the second cavity 112, the distal end of the lead wire 21 is electrically connected to the ablation element 24, the lead wire 21 has a buffer portion 211, the buffer portion 211 is housed in the receiving cavity 341, the buffer portion 211 has a first buffer point and a second buffer point, the first buffer point and the second buffer point are spaced apart along the axial direction of the lead wire 21, the buffer portion 211 is configured to be in a relaxed state when the tube assembly 1 is bent, and the first buffer point can move relative to the second buffer point when the tube assembly 1 is bent. When the tube assembly 1 is bent so that the lead wire 21 located on the outside of the bend is pulled, the first buffer point can move relative to the second buffer point to provide buffer for the bend, thereby releasing the tensile stress of the lead wire 21, thereby reducing the risk of loosening of the lead wire 21 welding point and damage to the insulation layer, and further reducing the risk of sparks generated during the discharge of the lead wire 21, improving the electrical connection reliability of the lead wire 21, reducing the risk of equipment failure due to the breakage of the lead wire 21 during the operation, and improving the safety and operational stability of the ablation catheter.

[0049] Furthermore, such as Figure 3 , Figure 4 , Figure 8 and Figure 9 As shown, the handle assembly 3 also includes a wire connector 34 disposed within the housing component 31. The wire connector 34 has a receiving cavity 341 and a wire hole 343 communicating with the receiving cavity 341. The push-pull tube 12 is movably inserted through the receiving cavity 341, and the wire 21 is inserted through the wire hole 343 and the receiving cavity 341. Since the wire connector 34 is provided with a receiving cavity 341 for accommodating the wire 21, interference with other structures or irregular structures of the inner wall of the housing can be avoided during the stretching process of the wire 21, thereby reducing the risk of damage to the wire 21.

[0050] In some embodiments, the ablation device includes multiple wire groups, each wire group including at least one wire 21; the wire connector 34 has multiple wire holes 343, which are spaced apart circumferentially along the wire connector 34. Each wire group is individually inserted into a wire hole 343, making the multiple wire groups relatively independent, reducing the risk of interference and entanglement between the wires 21 of the wire groups, and dispersing the multiple wires 21, reducing the number of wires 21 in a single wire hole 343, thereby reducing the inner diameter of the wire hole 343, and eliminating the need to consider the gaps formed between the wire groups, which facilitates the sealing of the wire hole 343.

[0051] In one embodiment, the wire connector 34 includes a proximal wall 344, a peripheral wall 345, and an extension tube 346. The proximal wall 344 is connected to the proximal end of the peripheral wall 345 and together defines a receiving cavity 341. The outer diameter of the extension tube 346 is smaller than the inner diameter of the receiving cavity 341. The extension tube 346 is connected to the proximal wall 344 and protrudes toward the receiving cavity 341. The extension tube 346 has a third cavity 342 communicating with the receiving cavity 341. The extension tube 346 and the wire hole 343 are spaced apart on the orthographic projection plane perpendicular to the central axis of the wire connector 34. Thus, the extension tube 346 can separate multiple wire groups from each other in the circumferential direction of the wire connector 34, reducing the risk of the wire groups getting tangled or knotted in the slack state or during the bending of the conduit, thereby reducing the risk of mutual interference of the buffer portions 211 of each wire group, allowing them to be released independently.

[0052] In one embodiment, the distal end of the first tube 33 is located within the third cavity 342, and the ablation device is configured such that the length of the third cavity 342 is greater than the travel distance of the first tube 33. When the first tube 33 moves axially, the inner wall of the third cavity 342 provides a certain radial limit for the distal end of the first tube 33, thereby improving the stability of the first tube 33's movement and thus improving the release accuracy of the ablation assembly 2. Furthermore, since the distal end of the first tube 33 is always located within the third cavity 342, there is no need to consider the possibility that the distal end of the first tube 33 may come into contact with the proximal end of the wire connector 34 and become immobile during its movement towards the distal end, thus reducing design complexity and cost. Moreover, since the distal end of the first tube 33 is always located within the third cavity 342, while the wire 21 is located outside the extension tube 346, the risk of damage to the wire 21 due to contact between the end of the first tube 33 and the wire 21 can be avoided.

[0053] In one embodiment, the length of the wire 21 along its own axial direction within the receiving cavity 341 is 'a', and the length of the receiving cavity 341 along its own axial direction is 'b', where ab = c, and 3mm ≤ c ≤ 40mm, where c can be 3mm, 10mm, 20mm, 30mm, or 40mm. The portion of the wire 21 within the receiving cavity 341 is in a relaxed state, forming a buffer portion 211 to provide cushioning for bending. Furthermore, 5mm ≤ c ≤ 20mm ensures that the wire 21 has sufficient buffering margin to release bending stress while avoiding excessive bending margin that could cause the wire 21 to become entangled or difficult to assemble within the receiving cavity 341.

[0054] In one embodiment, the ablation component 2 includes multiple wires 21, and the main tube 11 has multiple second cavities 112. The multiple second cavities 112 are circumferentially spaced along the first cavity 111. The wire connector 34 has multiple wire holes 343, which are circumferentially spaced along the third cavity 342. At least one wire 21 passes through each wire hole 343, and the portion of the multiple wires 21 near the wire connector 34 is bundled into a wire bundle 22. The multiple second cavities 112 and multiple wire holes 343 make the multiple wires 21 relatively independent, reducing problems such as interference, entanglement, and knotting between the multiple wires 21. During assembly, the threading path of the wires 21 is clear and fixed, eliminating the need for repeated adjustments to the position of the wires 21, reducing assembly difficulty and improving assembly efficiency. Furthermore, the multiple wires 21 are bundled into a wire bundle 22 after exiting from the proximal ends of the multiple wire holes 343, making the wiring arrangement at the proximal end neater and more compact, facilitating subsequent docking and assembly with the interface component. The handle assembly 3 is provided with an interface component, which is electrically connected to the proximal end of the wiring harness 22 and can also be connected to the host; optionally, the interface component has multiple interfaces, so that the wiring harness 22 can also be connected to other devices.

[0055] In one embodiment, each wire through hole 343 corresponds to at least one second cavity 112, and the wire 21 passing through the wire through hole 343 is disposed within the corresponding second cavity 112. One wire through hole 343 may correspond to one, two, or three second cavities 112, and the placement of the wire 21 is fixed, resulting in a clear wiring path and reduced assembly difficulty. In this embodiment, each wire through hole 343 corresponds to two second cavities 112, and the wire 21 passing through one wire through hole 343 is disposed within the corresponding two second cavities 112.

[0056] In one embodiment, at least one wire 21 passes through a second cavity 112 and a corresponding wire hole 343. During assembly, one or more wires 21 may be simultaneously passed through a second cavity 112 and a corresponding wire hole 343.

[0057] Furthermore, the wire hole 343 and the wire 21 are sealed together. Specifically, the wire hole 343 and the wire 21 can be sealed by applying adhesive. On the one hand, this connects the wire 21 to the wire connector 34, and on the other hand, it seals the wire hole 343.

[0058] like Figure 1 As shown, the handle assembly 3 also includes a flexible protective sleeve 37, which is connected to the distal end of the housing component 31, and the main body tube 11 passes through the flexible protective sleeve 37. The flexible protective sleeve 37 is located at the distal end of the front housing 311 and is made of a flexible material. The proximal end of the main body tube 11 passes through the center of the flexible protective sleeve 37, extends into the front housing 311, and connects to the tube connector 35. Therefore, when the operator holds the handle assembly 3, the distal end of the handle assembly 3 can make flexible contact with the main body tube 11 through the flexible protective sleeve 37, which can reduce the risk of the distal end of the handle assembly 3 breaking the main body tube 11, and at the same time make the distal end of the handle assembly 3 more aesthetically pleasing. The proximal end of the rear housing 312 can be provided with a grip area with damping texture. The contour shape of the grip area can be ergonomically designed to fit the grip shape of the human hand, providing a comfortable grip. When the user's four fingers (excluding the thumb) grip the grip area, the user's thumb can extend towards the distal end to turn the push knob 321. Turning the push knob 321 can be used to adjust the shape of the ablation component 2. The proximal end of the rear shell 312 is also provided with a tail wire sheath, which is used to protect the wire harness 22. The wire harness 22 can make flexible contact with the interface component through the tail wire sheath, avoiding damage to the wire harness 22 at the proximal end of the handle assembly 3, and at the same time making the proximal end of the handle assembly 3 more aesthetically pleasing.

[0059] Furthermore, such as Figure 2 , Figure 3 , Figure 10 and Figure 11As shown, the handle assembly 3 also includes an injection module 36 disposed within the housing component 31. A first tube 33 passes through the injection module 36 and is connected to the adjustment module 32. The injection module 36 includes a water supply pipe 361, which has a first flow channel connected to a second cavity 112. The portion of the wire 21 near the wire connector 34 and the water supply pipe 361 are located on the radial sides of the push-pull tube 12, respectively. The injection module 36 is disposed within the rear shell 312 of the housing component 31. The water supply pipe 361 can supply cooling medium, which sequentially passes through the first flow channel and the second cavity 112 to cool the ablation component 2. In this application, the portion of the wire 21 near the wire connector 34 (i.e., the wire harness 22) and the water supply pipe 361 are located on the two sides of the push-pull tube 12, respectively. The water supply pipe 361 and the wire 21 are spatially independent and do not affect each other. This will prevent interference between the wire 21 and the water supply pipe 361, reduce the impact on the wire 21, and improve the reliability of the ablation device.

[0060] In one embodiment, the infusion module 36 further includes a water tank component 362 and a second pipe component 363. The water tank component 362 is provided with a receiving cavity 3623, and a water supply pipe 361 is connected to the receiving cavity 3623. A second through hole 36212 is opened at the distal end of the receiving cavity 3623, and a third through hole 36221 is opened at the proximal end of the receiving cavity 3623. One end of the second pipe component 363 is inserted into the proximal end of the third cavity 342, and the other end is inserted into the second through hole 36212. The first pipe component 33 is slidably inserted from the distal end to the proximal end through the third cavity 342, the second pipe component 363, the receiving cavity 3623, and the third through hole 36221. An infusion gap communicating with the second cavity 112 is defined between the first pipe component 33 and the inner wall of the third cavity 342, and between the first pipe component 33 and the second pipe component 363. During injection, the cooling medium from the water supply pipe 361 passes sequentially through the receiving cavity 3623, the second through hole 36212, the injection gap between the second pipe fitting 363 and the first pipe fitting 33, the injection gap between the first pipe fitting 33 and the inner wall of the third cavity 342, the receiving cavity 341, and enters the second cavity 112. The cooling medium is then transported through the second cavity 112 to the ablation electrode at the far end to cool and dissipate heat for the ablation electrode.

[0061] Reference Figure 3In one embodiment, the handle assembly 3 further includes a tubular connector 35, which includes a distal connector tube 351 and a proximal connector tube 352. The distal connector tube 351 has a first connection hole 3511, and the proximal connector tube 352 has a second connection hole 3521. The first connection hole 3511 and the second connection hole 3521 communicate with each other. The main body tube 11 is inserted into the first connection hole 3511, and the wire guide connector 34 is inserted into the second connection hole 3521. The tubular connector 35 supports and connects the wire guide connector 34 and the main body tube 11, and forms a receiving cavity 341 between the tubular connector 35 and the wire guide connector 34 to house the buffer part 211 in a relatively enclosed space. This further reduces the risk of the buffer part 211 being exposed to other areas of the handle and interfering with other structures, thereby further reducing the risk of damage to the wire 21.

[0062] Furthermore, in this embodiment, the main body tube 11 is inserted into the first connecting hole 3511, thereby increasing the connection area between the main body tube 11 and the handle assembly 3, improving the sealing performance between the main body tube 11 and the handle assembly 3, and reducing the risk of cooling medium leakage. Similarly, the wire connector 34 is inserted into the second connecting hole 3521, increasing the contact area between the wire connector 34 and the main body tube 11, that is, increasing the contact area at the connection point between the wire connector 34 and other structural components, thereby improving the sealing performance of the connection points between the wire connector 34 and other structures, and further reducing the risk of cooling medium leakage. The pipe fitting connector 35 is disposed inside the front housing 311, and the main body tube 11 and the wire connector 34 are fixed through the pipe fitting connector 35. The wire connector 34 and the inner wall of the second connecting hole 3521 can be connected by adhesive, and the main body tube 11 and the inner wall of the first connecting hole 3511 can also be connected by adhesive, improving the connection strength.

[0063] In one embodiment, the injection module 36 further includes a first sealing ring 364, which is sealed around the outside of the first tube 33 and sealed to the inner wall of the third through hole 36221. During the pushing and pulling process of the first tube 33, the first tube 33 slides back and forth in the clamping of the first sealing ring 364, thereby preventing the cooling medium from flowing out. In addition, the first sealing ring 364 can provide a certain damping for the first tube 33, thereby restricting the rotation of the first tube 33 and suspending the entire adjustment module 32 on the first tube 33. This reduces the risk of the adjustment module 32 connected to the first tube 33 contacting the housing component 31 due to the rotation of the first tube 33, thereby reducing wear on the housing component 31 and the adjustment module 32 and improving the smoothness of the movement of the adjustment module 32. Furthermore, the first sealing ring 364 provides a relatively constant damping force to the first tube 33, improving the uniformity and consistency of the operating feel, thereby enhancing the user experience.

[0064] In one embodiment, the filling module 36 further includes a water pipe connector 365, and the water tank component 362 also has a first insertion hole 36211 communicating with the receiving cavity 3623. The first insertion hole 36211 extends to the radial sidewall of the water tank component 362, and the water pipe connector 365 is connected to the first insertion hole 36211. The water pipe connector 365 has a second insertion hole 3651, and the water supply pipe 361 is inserted into the second insertion hole 3651. The water supply pipe 361 is connected to the sidewall of the water tank component 362 through the water pipe connector 365, so that the position of the water supply pipe 361 can be located on one side of the water tank component 362, which facilitates spatial layout. The distal end of the water supply pipe 361 can be glued and fixed to the second insertion hole 3651 of the water pipe connector 365 to achieve a sealed and fixed connection.

[0065] The water tank component 362 includes a tank body 3621 and an end cap 3622. The end cap 3622 is sealed to the tank body 3621 and defines a receiving cavity 3623. The tank body 3621 is located at the distal end of the water tank component 362 and has a second through hole 36212 and a first insertion hole 36211. The end cap 3622 is located at the proximal end of the water tank component 362 and has a third through hole 36221. The tank body 3621 and the end cap 3622 are connected by screws to form the receiving cavity 3623 between them. A second sealing ring 366 is provided between the tank body 3621 and the end cap 3622 to achieve a seal between them.

[0066] In other embodiments, this application provides a method for manufacturing an ablation device, comprising at least the following steps: Provided are tube assembly 1, ablation assembly 2 and handle assembly 3; wherein, ablation assembly 2 includes main tube 11 and push-pull tube 12, the main tube 11 is provided with a first cavity 111 along its own axial direction, and handle assembly 3 includes housing component 31, adjustment module 32 and first tube component 33.

[0067] S1. The push-pull tube 12 is movably inserted into the first cavity 111.

[0068] S2. Connect the proximal end of the ablation component 2 to the distal end of the main tube 11.

[0069] S3. Connect the proximal end of the ablation component 2 to the distal end of the push-pull tube 12.

[0070] S4. Connect the near end of the main tube 11 to the housing component 31.

[0071] S6. Install the proximal end of the push-pull tube 12 into the housing component 31.

[0072] S7. Fit the first fitting 33 onto the near end of the push-pull tube 12 and connect the first fitting 33 to the push-pull tube 12.

[0073] S8. Connect the adjustment module 32 to the first tube 33. The adjustment module 32 can drive the first tube 33 to move back and forth along its own axis, so as to drive the push-pull tube 12 to move, so that the ablation component 2 switches between the expansion state and the contraction state.

[0074] At least one embodiment of this application provides an ablation system, which includes a pulse generator and the ablation device described above, wherein the ablation component 2 is coupled to the pulse generator and configured to receive pulse waveforms.

[0075] It should be noted that the technical solutions formed by any combination of the above-described embodiments (or examples) are all within the scope of protection of this application. It is understood that "any" refers to any single embodiment or implementation method, as well as multiple embodiments or combinations thereof.

[0076] Whenever a range of values ​​is indicated in this application, it refers to any of the listed values ​​(fractions and integers) that fall within the indicated range. The phrases “range between the first indicated value and the second indicated value” and “range from the first indicated value to the second indicated value” are used interchangeably in this application and refer to the values ​​indicated by the first and second indications, as well as all fractional and integer values ​​in between.

[0077] As used herein, when used in conjunction with numerical values ​​and / or ranges, the terms “about” and / or “approximately” generally refer to those numerical values ​​and / or ranges that are close to the stated numerical value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of the stated value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[0078] As used in this application, the singular forms “an,” “a,” and “the” include the plural forms unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include a variety of compounds, including mixtures thereof.

[0079] The term "basically composed of" means that the composition, method, or structure may include additional ingredients, steps, and / or components, provided that these additional ingredients, steps, and / or components do not significantly alter the fundamental and novel properties of the claimed composition, method, or structure.

[0080] The implementation of the methods and / or systems of this application may include performing or fully performing selected tasks manually, automatically, or in a combination thereof. Furthermore, the actual instruments and equipment used in the implementation of the methods and / or systems of this application, using an operating system, may implement several selected tasks via hardware, software, firmware, or a combination thereof.

Claims

1. An ablation device, characterized in that, include: The tube assembly includes a main tube and a push-pull tube, wherein the main tube has a first cavity along its own axial direction, and the push-pull tube is movably inserted into the first cavity; An ablation assembly, wherein the proximal end of the ablation assembly is connected to the distal end of the main tube, and the distal end of the push-pull tube is tractively connected to the distal end of the ablation assembly; The handle assembly includes a housing component, an adjustment module, and a first tube. The proximal end of the push-pull tube is located inside the housing component. The first tube is sleeved and connected to the proximal end of the push-pull tube. The adjustment module is throttle-connected to the first tube. The adjustment module is used to drive the first tube to reciprocate along its own axis, thereby moving the push-pull tube and switching the ablation component between an expanded state and a contracted state.

2. The ablation device according to claim 1, characterized in that, The hardness of the first tube is greater than that of the push-pull tube.

3. The ablation device according to claim 1, characterized in that, The adjustment module includes a push knob and a connecting component, the connecting component connecting the first tube and the push knob; the push knob is at least partially disposed outside the housing component.

4. The ablation device according to claim 3, characterized in that, The connecting component includes a bracket and a base. The push-button is connected to the bracket, and the bracket is detachably connected to the base. Together, they define a first through hole extending axially. The first tube passes through the first through hole and is connected to the inner wall of the first through hole.

5. The ablation device according to claim 3, characterized in that, The outer wall of the housing component is provided with an elongated hole, the push knob is configured to move along the extension direction of the elongated hole, and the adjustment module is spaced apart from the inner wall of the elongated hole in its own width direction.

6. The ablation device according to any one of claims 1-5, characterized in that, The main tube has a second cavity along its own axial direction, and the handle assembly has a receiving cavity; The ablation assembly includes an ablation element and a wire. The wire passes through the second cavity and is electrically connected at its distal end to the ablation element. The wire has a buffer portion housed in the receiving cavity. The buffer portion has a first buffer point and a second buffer point, which are spaced apart along the axial direction of the wire. The buffer portion is configured to be in a relaxed state when the tube assembly is bent, and the first buffer point is movable relative to the second buffer point when the tube assembly is bent.

7. The ablation device according to claim 6, characterized in that, The handle assembly further includes a wire connector disposed within the housing component, the wire connector having the receiving cavity and a wire hole communicating with the receiving cavity, the push-pull tube being movably inserted through the receiving cavity, and the wire being inserted through the wire hole and the receiving cavity.

8. The ablation device according to claim 7, characterized in that, The ablation assembly includes multiple lead wire groups, and each lead wire group includes at least one lead wire. The wire connector has multiple wire holes, which are spaced apart circumferentially along the wire connector, and each wire group is individually threaded through one wire hole.

9. The ablation device according to claim 8, characterized in that, The cable connector includes a proximal wall, a peripheral wall, and an extension tube. The proximal wall is connected to the proximal end of the peripheral wall and together defines the receiving cavity. The outer diameter of the extension tube is smaller than the inner diameter of the receiving cavity. The extension tube is connected to the proximal wall and protrudes toward the receiving cavity. The extension tube has a third cavity communicating with the receiving cavity. The first tube is movably inserted through the third cavity. The extension tube and the wire-passing hole are spaced apart on the projection plane perpendicular to the central axis of the wire-passing connector.

10. The ablation device according to claim 9, characterized in that, The distal end of the first tube is located within the third cavity, and the ablation device is configured such that the length of the third cavity is greater than the travel distance of the first tube.

11. The ablation device according to claim 6, characterized in that, The length of the wire along its own axis within the receiving cavity is a, and the length of the receiving cavity along its own axis is b, where ab = c, and 3mm ≤ c ≤ 40mm.

12. The ablation device according to claim 11, characterized in that, 5mm≤c≤20mm.

13. The ablation device according to claim 9, characterized in that, The ablation assembly includes a plurality of the wires, the main tube has a plurality of second cavities, the plurality of second cavities are arranged circumferentially at intervals along the first cavity, the wire connector is provided with a plurality of wire holes, the plurality of wire holes are arranged circumferentially at intervals along the third cavity, each wire hole has at least one wire inserted through it, and the portion of the plurality of wires near the end of the wire connector is bundled into a wire bundle.

14. The ablation device according to claim 13, characterized in that, Each of the aforementioned through holes corresponds to at least one of the second cavities.

15. The ablation device according to claim 13, characterized in that, Each of the wire holes corresponds to two second cavities.

16. The ablation device according to claim 14 or 15, characterized in that, At least one of the wires passes through a second cavity and a corresponding wire hole of the second cavity.

17. The ablation device according to claim 7, characterized in that, The wire hole is sealed to the wire.

18. The ablation device according to claim 9, characterized in that, The handle assembly further includes an injection module disposed within the housing component, wherein the first tube passes through the injection module and is connected to the adjustment module; The injection module includes a water supply pipe with a first flow channel connected to the second cavity. The portion of the wire near the wire connector and the water supply pipe are located on the radial sides of the push-pull tube, respectively.

19. The ablation device according to claim 18, characterized in that, The infusion module further includes a water tank component and a second pipe. The water tank component is provided with a receiving cavity, and the water supply pipe is connected to the receiving cavity. A second through hole is opened at the distal end of the receiving cavity, and a third through hole is opened at the proximal end of the receiving cavity. One end of the second pipe is inserted into the proximal end of the third cavity, and the other end is inserted into the second through hole. The first pipe is slidably inserted from the distal end to the proximal end through the third cavity, the second pipe, the receiving cavity, and the third through hole. An infusion gap communicating with the second cavity is defined between the first pipe and the inner wall of the third cavity, and between the first pipe and the second pipe.

20. The ablation device according to claim 19, characterized in that, The handle assembly also includes a pipe fitting, which includes a distal connector and a proximal connector. The distal connector has a first connection hole, and the proximal connector has a second connection hole. The first connection hole communicates with the second connection hole. The main body is inserted into the first connection hole, and the wire connector is inserted into the second connection hole.

21. The ablation device according to claim 20, characterized in that, The injection module also includes a first sealing ring, which is sealed and sleeved on the outside of the first pipe and sealed to the inner wall of the third through hole.

22. The ablation device according to claim 20, characterized in that, The injection module also includes a water pipe connector, and the water tank component also has a first insertion hole communicating with the receiving cavity. The first insertion hole extends to the radial sidewall of the water tank component. The water pipe connector is connected to the first insertion hole, and the water pipe connector has a second insertion hole. The water supply pipe is inserted into the second insertion hole.

23. The ablation device according to claim 20, characterized in that, The water tank component includes a tank body and an end cap, the end cap being sealed to the tank body and defining the receiving cavity.

24. The ablation device according to claim 1, characterized in that, The handle assembly also includes a flexible protective sleeve connected to the distal end of the housing component, and the main tube passes through the flexible protective sleeve.

25. A method for manufacturing an ablation device, characterized in that, It should include at least the following steps: A tube assembly, an ablation assembly, and a handle assembly are provided; wherein, the ablation assembly includes a main tube and a push-pull tube, the main tube has a first cavity along its own axial direction, and the handle assembly includes a housing component, an adjustment module, and a first tube fitting; The push-pull tube is movably inserted into the first cavity; The proximal end of the ablation component is connected to the distal end of the main tube; The proximal end of the ablation component is connected to the distal end of the push-pull tube; The proximal end of the main tube is connected to the housing component; The proximal end of the push-pull tube is installed inside the housing component; The first fitting is sleeved onto the proximal end of the push-pull tube, and the first fitting is connected to the push-pull tube; The adjustment module is connected to the first tube, and the adjustment module can drive the first tube to reciprocate along its own axis to move the push-pull tube, so that the ablation component switches between an expanded state and a contracted state.

Images