Ablation device

Abstract

The ablation device and tube assembly comprises an inner tube and a sheath tube arranged outside the inner tube in a sleeving mode, the inner tube communicates with a liquid supply device, and the liquid supply device is used for providing cooling liquid for the inner tube; the ablation unit is arranged on the far-end side of the inner tube in a sleeving mode, ablation electrodes distributed annularly are arranged at the far end of the ablation unit, and the ablation electrodes are used for being attached to the inner wall of the targeted tissue and releasing ablation energy; the collecting unit is connected with the far end of the inner tube and axially spaced on the far end side of the ablation unit, spraying holes used for spraying cooling liquid to the ablation electrode are formed in the portion, between the ablation unit and the collecting unit, of the inner tube, and the collecting unit is used for collecting the sprayed cooling liquid. In the ablation process, the cooling liquid is recycled while the ablation electrode is cooled, and the possibility of other diseases caused by the fact that the cooling liquid enters human body targeted tissue is reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to an ablation device. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is the most common type of chronic airway disease, severely impacting patients' quality of life and a leading cause of death. Targeted lung denervation (TLD), a recent trend in the treatment of bronchitis-related COPD, primarily uses an ablation device to release ablation energy to ablate the parasympathetic nerves on the outer wall of the bronchi, thereby blocking the transmission of nerve signals. This relaxes the airway smooth muscle, reduces mucus secretion, and thus improves symptoms of airway obstruction and dyspnea.

[0003] The ablation device includes an ablation electrode that adheres to the bronchial wall for ring-shaped ablation. To minimize damage to the bronchial wall tissue while ablating the bronchial parasympathetic nerves, the ablation electrode is typically cooled by spraying coolant. However, the coolant can enter and remain in the bronchial branches of the lungs, potentially causing problems such as bronchial effusion. Summary of the Invention

[0004] The purpose of this application is to provide an ablation device for recovering coolant and reducing the accumulation of coolant that causes bronchial effusion in the lungs.

[0005] Therefore, this application provides an ablation device, comprising: a tube assembly including an inner tube and a sheath sleeved outside the inner tube, the inner tube being connected to a liquid supply device for supplying coolant to the inner tube; an ablation unit sleeved on the distal end of the inner tube, the distal end of the ablation unit being provided with ablation electrodes arranged in a ring, the ablation electrodes being used to adhere to the inner wall of the target tissue and release ablation energy; and a collection unit connected to the distal end of the inner tube and axially spaced from the distal end of the ablation unit, wherein the inner tube between the ablation unit and the collection unit is provided with a spray hole for spraying coolant onto the ablation electrodes, and the collection unit being used to collect the sprayed coolant.

[0006] In some embodiments of this application, the collection unit includes a support tube and a self-deploying collection umbrella connected to the distal end of the support tube. The end of the support tube away from the collection umbrella is connected to the distal end of the inner tube. The collection umbrella includes a plurality of elastic rods spaced apart circumferentially along the support tube and a flexible membrane covering the plurality of elastic rods. The elastic rods are arc-shaped rods bent toward the proximal end of the inner tube.

[0007] In some embodiments of this application, the support tube is provided with a suction hole that communicates with the inner tube.

[0008] In some embodiments of this application, a valve body is also provided inside the inner tube, and the valve body is located between the spray hole and the suction hole. When the valve body is closed, the inner tube sprays coolant onto the ablation electrode through the spray hole; when the valve body is open, the collection unit draws the coolant collected by the collection umbrella into the inner tube through the suction hole.

[0009] In some embodiments of this application, the valve body includes a screen, a blocking member, and a limiting member arranged sequentially along the axial direction of the inner tube. The screen is located at the far end of the spray hole. The limiting member has a through groove. The blocking member can move between the screen and the limiting member. When the blocking member moves to the limiting member and closes the through groove, the valve body is closed. When the blocking member moves to the screen, the valve body is opened.

[0010] In some embodiments of this application, the valve body is threaded to the inner wall of the inner tube;

[0011] And / or, the inner tube includes a first tube segment and a second tube segment arranged sequentially and connected along its own axial direction, the first tube segment is provided with a spray hole and connected to the ablation unit, the second tube segment is provided with a valve body and connected to the collection unit, and the distal end of the first tube segment is threadedly connected to the proximal end of the second tube segment.

[0012] In some embodiments of this application, a section of the inner tube located on the proximal side of the ablation unit is provided with a spiral groove of a predetermined length and an elastic membrane covering the spiral groove.

[0013] In some embodiments of this application, the ablation unit and the collection unit are foldably disposed between the inner tube and the sheath. In the first state, the collection unit and the ablation unit can extend and unfold sequentially from the distal end of the sheath so that the ablation electrode can fit against the inner wall of the target tissue. At the same time, coolant is sprayed onto the ablation electrode through the spray hole, and the coolant sprayed from the spray hole is collected by the collection unit. In the second state, the ablation unit and the collection unit can retract sequentially toward the proximal end of the sheath so that the ablation unit and the collection unit are gathered together inside the sheath.

[0014] In some embodiments of this application, the ablation unit includes a connecting rod and a support frame disposed at the distal end of the connecting rod. The connecting rod is connected to the inner tube, and at least a portion of the connecting rod is located between the inner tube and the sheath. The support frame includes a plurality of deformation units arranged circumferentially around itself. The plurality of deformation units are adjacent to each other and can deform independently relative to the adjacent deformation unit. An ablation electrode is disposed at the distal end of each deformation unit.

[0015] The connecting rod includes multiple connecting arms spaced apart along its circumference, and the multiple connecting arms are connected one-to-one with the proximal ends of multiple deformation units; in the first state, the ablation unit extends from the distal end of the sheath to make the support skeleton unfold in a funnel shape.

[0016] In some embodiments of this application, each deformation unit includes a first deformation portion and a second deformation portion connected in the circumferential direction along the support frame, and the first deformation portion of each deformation unit is adjacent to the second deformation portion of the adjacent deformation unit.

[0017] The support frame also includes multiple main rods, which are spaced apart circumferentially along the support frame. The proximal end of each main rod is connected to the free end of the connecting arm, and the distal end of each main rod is simultaneously connected to the proximal ends of two adjacent first and second deformation parts in two adjacent deformation units. There is a gap between the proximal ends of the two adjacent first and second deformation parts in two adjacent deformation units, and the width of the gap gradually decreases from the proximal end to the distal end along the circumferential direction.

[0018] The ablation device of this application can collect coolant during ablation and remove it after ablation, minimizing coolant entry into the lungs and preventing coolant accumulation in the bronchi that could cause other diseases. It also ensures that coolant is sprayed onto the electrodes during ablation, maintaining the flexibility of the sheath. Furthermore, the ablation unit and the collection unit can move synchronously, retracting into and releasing the sheath, making operation simple.

[0019] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description

[0020] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein:

[0021] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein:

[0022] Figure 1 This is a schematic diagram of the structure of an ablation device according to an embodiment of this application;

[0023] Figure 2 for Figure 1 The diagram shows the structure of the ablation device after the sheath is removed.

[0024] Figure 3This is a schematic diagram of the ablation device according to another embodiment of this application after the sheath is removed;

[0025] Figure 4 This is a schematic diagram of the ablation device according to another embodiment of this application after the sheath is removed;

[0026] Figure 5 for Figure 2 A magnified structural diagram of region A in the middle;

[0027] Figure 6 This is a schematic diagram of the ablation unit of an ablation device according to an embodiment of this application;

[0028] Figure 7 for Figure 6 A schematic diagram of the structure of the ablation unit viewed along the axial direction;

[0029] Figure 8 for Figure 6 A magnified structural diagram of region B in the middle.

[0030] The labels in the attached diagram are as follows:

[0031] 100. Ablation device;

[0032] 1. Pipe assembly; 11. Inner pipe; 11a. First pipe section; 11b. Second pipe section; 111. Spray hole; 112. Spiral groove; 113. Elastic membrane; 12. Sheath;

[0033] 2. Ablation unit; 20. Ablation electrode; 21. Connecting rod; 211. Connecting arm; 22. Support frame; 221. Deformation unit; 2211. First deformation part; 2212. Second deformation part; 222. Main rod; 223. First wire hole; 224. Second wire hole;

[0034] 3. Collection unit; 31. Support tube; 311. Suction hole; 32. Collection umbrella; 321. Elastic rod; 322. Flexible membrane;

[0035] 4. Valve body; 41. Screen; 42. Limiting element; 421. Through groove; 43. Blocking element;

[0036] 5. Wire; S, gap. Detailed Implementation

[0037] Exemplary embodiments of this application will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this application are shown in the drawings, it should be understood that this application may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this application and to fully convey the scope of this application to those skilled in the art.

[0038] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0039] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0040] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0041] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0042] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; 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. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0043] In this paper, the end closer to the operator is defined as the proximal end, and the end farther from the operator is defined as the distal end. This definition is used to describe the proximal and distal ends of a component, as well as the relative positional relationships between components.

[0044] The ablation device is used to generate ablation energy at a target tissue in the human body. This ablation energy can ablate nerves within the tissue, thereby achieving a therapeutic effect on the affected area. The exemplary ablation device of this application can be used for ablation of areas such as the airway, heart, aorta, and stomach. For example, in various embodiments of this application, by delivering the ablation device into the airway and then ablating nerves in the airway tissue, the thickness of the airway wall can be reduced to alleviate airway obstruction.

[0045] Figure 1 This is a schematic diagram of the structure of an ablation device according to an embodiment of this application.

[0046] See Figure 1 This application provides an ablation device 100, which includes a tube assembly 1, an ablation unit 2, and a collection unit 3.

[0047] The tube assembly 1 includes an inner tube 11 and a sheath 12 sleeved outside the inner tube 11. The inner tube 11 can move axially relative to the sheath 12. The inner tube 11 has a cavity, which allows the inner tube 11 to communicate with an external liquid supply device, which is used to supply coolant to the inner tube 11.

[0048] Combination Figure 1 and Figure 6 and Figure 7As shown, the ablation unit 2 is sleeved on the outer periphery of the distal end of the inner tube 11. The distal end of the ablation unit 2 is provided with an ablation electrode 20, which is used to adhere to the inner wall of the target tissue and release ablation energy.

[0049] The collecting unit 3 is connected to the distal end of the inner tube 11 and is axially spaced from the distal end of the ablation unit 2. That is, the ablation unit 2 and the collecting unit 3 are spaced apart from the proximal end to the distal end along the axial direction of the inner tube 11. The inner tube 11 between the ablation unit 2 and the collecting unit 3 is provided with a spray hole 111 for spraying coolant onto the ablation electrode 20. The collecting unit 3 is used to collect the sprayed coolant, that is, to collect the coolant sprayed from the spray hole 111.

[0050] In this embodiment, the ablation unit 2 can be welded to the outer periphery of the inner tube 11. The ablation electrode 20 provided at the distal end of the ablation unit 2 is used to adhere to the inner wall of the target tissue and release ablation energy. The target tissue can be, for example, the lesion tissue of the bronchus in the lungs. By releasing ablation energy, the parasympathetic nerves on the outer wall of the bronchus can be ablated, thereby blocking the transmission of nerve signals, relaxing the airway smooth muscle, reducing mucus secretion, and improving the symptoms of airway obstruction and dyspnea.

[0051] The ablation unit 2 and the collection unit 3 are foldably disposed between the inner tube 11 and the sheath tube 12. In the first state, the collection unit 3 and the ablation unit 2 extend and unfold from the distal end of the sheath tube 12 in sequence so that the ablation electrode 20 can fit against the inner wall of the target tissue. At the same time, coolant is sprayed onto the ablation electrode 20 through the spray hole 111, and the coolant sprayed from the spray hole 111 is collected by the collection unit 3. In the second state, the ablation unit 2 and the collection unit 3 retract toward the proximal end of the sheath tube 12 in sequence so that the ablation unit 2 and the collection unit 3 are gathered together inside the sheath tube 12.

[0052] See Figure 6 and Figure 7 Optionally, the ablation electrode 20 is electrically connected to an external power supply via the wire 5 to achieve ring-shaped ablation. In one example, there are multiple ablation electrodes 20, which are distributed in a ring at intervals at the distal end of the ablation unit 2. The ablation electrodes 20 can be made of at least one of gold, tungsten, and copper. In another example, the ablation electrode 20 at the distal end of the ablation unit 2 forms a ring structure. This ring structure can be a conductive layer disposed at the distal end of the ablation unit 2, and the surface of the conductive layer is plated with gold to improve conductivity.

[0053] Because the ablation electrode 20 heats up during the ablation process, to reduce damage to the bronchial wall tissue, coolant is sprayed onto the ablation electrode 20 through a spray hole 111 on the inner tube 11. This lowers the temperature of the ablation electrode 20 and its surrounding tissues. Simultaneously, a collection unit 3 located at the distal end of the inner tube 11 collects the coolant sprayed from the spray hole 111. Specifically, during ablation, the self-deploying ablation unit 2 and collection unit 3 adhere to the inner wall of the target tissue, forming a collection space between them. The spray hole 111 is located on the portion of the inner tube 11 between the ablation unit 2 and the collection unit 3. After being sprayed through the spray hole 111, the coolant converges into this collection space and is collected by the collection unit 3 after cooling the ablation electrode 20. This reduces the possibility of coolant entering the lungs and other target tissues, preventing other diseases caused by coolant accumulation in the lungs and bronchi.

[0054] Optionally, such as Figure 1 As shown, there are multiple spray holes 111 arranged in a ring array along the outer circumferential surface of the inner tube 11. That is, the multiple spray holes 111 are spaced apart in both the axial and circumferential directions of the inner tube 11, thereby cooling the ablation electrode 20 at the distal end of the ablation unit 2 and the surrounding target tissue. Preferably, in order to ensure that the spraying can directly act on the ablation electrode 20, the spray holes 111 are radially opposite to the ablation electrode 20 on the self-deploying ablation unit 2.

[0055] In addition, the coolant in the inner tube 11 is supplied by an external fluid supply device. The coolant can be, for example, but not limited to, saline solution, and the fluid supply device can be, for example, but not limited to, a peristaltic pump. Specifically, the peristaltic pump includes a driver, a pump head, and a hose. The hose surrounds the outer periphery of the driver. One end of the hose is connected to the pump head through an inlet pipe, and the other end of the hose is connected to the inner tube 11 through an outlet pipe. The coolant is isolated in the hose, and the coolant is pumped by alternately squeezing and releasing the hose through the rotation of the driver.

[0056] According to the ablation device 100 provided in the embodiments of this application, by arranging the collection unit 3 and the ablation unit 2 axially spaced along the inner tube 11, and providing a spray hole 111 on the inner tube 11 between the ablation unit 2 and the collection unit 3, the spray hole 111 is used to spray coolant onto the ablation electrode 20 at the distal end of the ablation unit 2, and the collection unit 3 is used to collect the coolant sprayed from the spray hole 111. Thus, the ablation device 100 can cool the ablation electrode 20 during the ablation process and recover the coolant, avoiding the problem of excessive coolant remaining in the branches of the lung bronchi and causing bronchial effusion.

[0057] like Figure 1As shown, in some embodiments, the collection unit 3 includes a support tube 31 and a self-deploying collection umbrella 32 connected to the distal end of the support tube 31. The collection unit 3 is configured as an umbrella-shaped structure. The collection umbrella 32 can deform and converge under the action of external force. The end of the support tube 31 away from the collection umbrella 32 is connected to the distal end of the inner tube 11. The collection umbrella 32 includes a plurality of elastic rods 321 arranged circumferentially along the support tube 31 and a flexible membrane 322 covering the plurality of elastic rods 321. After the elastic rods 321 are connected to the support tube 31, they extend radially toward the distal end and then flip toward the proximal end, so that the elastic rods 321 are arc-shaped rods bent toward the proximal end of the inner tube. The plurality of elastic rods 321 can self-deploy to form a radially distributed collection skeleton. The flexible membrane 322 is connected to multiple elastic rods 321. The flexible membrane 322 covers the multiple elastic rods 321 to form an umbrella surface with a receiving cavity. The flexible membrane 322 unfolds as the elastic rods 321 unfold, forming a radial collection surface. The multiple elastic rods 321 cooperate with the flexible membrane 322 to collect the coolant sprayed from the spray hole 111.

[0058] In this embodiment, the collecting umbrella 32 can self-deploy and deform under external force. After completing the ablation and collection work, the sheath 12 is moved toward the distal end or the inner tube 11 is moved backward, so that the self-deployed ablation unit 2 and collecting unit 3 deform sequentially and re-enter the sheath 12. When the umbrella-shaped collecting unit 3 deforms, the proximal ends of its multiple elastic rods 321 first gradually converge, and with axial movement, the free ends of the flipped elastic rods 321 flip toward the distal end again and converge accordingly.

[0059] Optionally, the elastic rod 321 is made of nickel-titanium alloy, a shape memory alloy that can automatically recover its original shape after plastic deformation at a specific temperature. It has good plasticity, facilitating repeated folding and unfolding, and improving the service life of the collection unit 3. Optionally, the flexible membrane 322 is made of polytetrafluoroethylene (PTFE), which has good elastic deformation, facilitating unfolding and folding along with the elastic rod 321. PTFE also possesses excellent chemical stability, corrosion resistance, sealing properties, high lubricity and non-stickiness, electrical insulation, and good anti-aging resistance, making it suitable for contact with coolants such as physiological saline without damage.

[0060] In some embodiments, the support tube 31 is provided with a suction hole 311 that communicates with the inner tube 11, through which the coolant collected by the collecting umbrella 32 can be sucked into the inner tube 11.

[0061] like Figure 1As shown, the support tube 31 is provided with a suction hole 311 that communicates with the inner tube 11. There are multiple suction holes 311, which are spaced apart along the outer circumferential surface of the support tube 31. The coolant collected by the flexible membrane 322 can be sucked into the inner tube 11 and then extracted through the suction hole 311.

[0062] Figure 2 for Figure 1 The diagram shows the structure of the ablation device after the sheath is removed.

[0063] In some embodiments, a valve body 4 is also provided inside the inner tube 11, and the valve body 4 is located between the spray hole 111 and the suction hole 311. When the valve body 4 is closed, the inner tube 11 sprays coolant to the ablation electrode 20 through the spray hole 111; when the valve body 4 is open, the collection unit 3 draws the coolant collected by the collection umbrella 32 into the inner tube 11 through the suction hole 311.

[0064] See Figure 2 The valve body 4 is disposed inside the inner tube 11 and located between the spray hole 111 and the suction hole 311, and is used to control the spraying or recovery of coolant in the inner tube 11. The valve body 4 can be a one-way valve, ensuring that the inner cavity of the inner tube 11 can only form a passage in one direction, facilitating the spraying of coolant to the ablation electrode 20 through the spray hole 111. The valve body 4 can also be a one-way solenoid valve, controlling its opening and closing via an electrical signal. Alternatively, the valve body 4 can be a one-way mechanical valve, eliminating the need for wiring and other components, simplifying the structure of the ablation device 100, and reducing costs.

[0065] In some embodiments, the valve body 4 includes a screen 41, a blocking member 43, and a limiting member 42 arranged sequentially along the axial direction of the inner tube 11. The screen 41 is arranged adjacent to the spray hole 111. The limiting member 42 is provided with a through groove 421. The blocking member 43 can move between the screen 41 and the limiting member 42 with pressure. When the blocking member 43 moves to the limiting member 42 and closes the through groove 421, the valve body 4 is closed. When the blocking member 43 moves to the screen 41, the valve body 4 is opened.

[0066] like Figure 2 As shown, the valve body 4 is a one-way mechanical valve, which includes a screen 41, a blocking element 43, and a limiting element 42 arranged sequentially along the axial direction of the inner tube 11. The screen 41, the blocking element 43, and the limiting element 42 can all be metal parts, made of materials such as stainless steel or nickel-titanium alloy, to prevent the valve body 4 from being corroded by the coolant. The screen 41 and the limiting element 42 can be welded to the inner wall of the inner tube 11 respectively. The blocking element 43 can move between the screen 41 and the limiting element 42 with pressure to close or open the valve body 4.

[0067] The working principle of valve body 4 is as follows: Taking the liquid supply device as a peristaltic pump as an example, when ablation begins, the peristaltic pump is turned on. During the process of the driver rotating in the forward direction to pump the coolant into the inner tube 11, positive pressure can be generated, which pushes the blocking member 43 to move to the limiting member 42 and closes the through groove 421. At this time, valve body 4 is closed, but it will not affect the coolant spraying out from the spray hole 111 located on the near end side of valve body 4. At this time, the coolant is only sprayed out from the spray hole 111 to cool the ablation electrode 20. When the ablation is completed and the coolant is recovered, the driver of the peristaltic pump rotates in the reverse direction to draw the coolant. A negative pressure is formed in the inner tube 11. The screen 41 has mesh holes. Due to the pressure difference on both sides, the blocking member 43 moves to the screen 41. At this time, valve body 4 is opened, and the coolant collected by the collecting umbrella 32 is drawn into the inner tube 11 through the suction hole 311.

[0068] Optionally, the blocking member 43 is a spherical structure, and at least one end of the through groove 421 in the limiting member 42 is a tapered hole that gradually expands outward along the axial direction. The diameter of the blocking member 43 is larger than the inner diameter of the through groove 421 and smaller than the maximum outer diameter of the tapered hole. In this way, when the blocking member 43 moves to the limiting member 42, it can close the through groove 421 to close the valve body 4. At the same time, the tapered hole can accommodate the blocking member 43, preventing the spherical structure from moving under the action of external force and opening the valve body 4.

[0069] Figure 3 This is a schematic diagram of the ablation device according to another embodiment of this application after the sheath is removed.

[0070] In some embodiments, the valve body 4 is threadedly connected to the inner wall of the inner tube 11.

[0071] See Figure 3 The screen 41 and the limiting member 42 of the valve body 4 are respectively threaded to the inner wall of the inner tube 11. Compared with the welding method, the threaded connection method can adjust the position of the valve body 4 in the inner tube 11 to match different ablation devices 100 and expand the application range of the ablation device 100. On the other hand, it also simplifies the assembly process of the valve body 4 and reduces the manufacturing cost.

[0072] Figure 4 This is a schematic diagram of the ablation device according to another embodiment of this application after the sheath is removed.

[0073] In some embodiments, the inner tube 11 includes a first tube segment 11a and a second tube segment 11b arranged sequentially and connected along its own axial direction. The first tube segment 11a is provided with a spray hole 111 and is connected to the ablation unit 2. The second tube segment 11b is provided with a valve body 4 and is connected to the collection unit 3. The distal end of the first tube segment 11a is threadedly connected to the proximal end of the second tube segment 11b.

[0074] See Figure 4The inner tube 11 includes a first tube segment 11a and a second tube segment 11b arranged sequentially and connected along its own axial direction. The ablation unit 2 can be welded to the first tube segment 11a, and the spray hole 111 is provided on the first tube segment 11a. The collection unit 3 can be welded to the distal end of the second tube segment 11b through the support tube 31. The screen 41 and the limiting member 42 of the valve body 4 can be welded to or threaded to the inner wall of the second tube segment 11b. Either the distal end of the first tube segment 11a or the proximal end of the second tube segment 11b is provided with an internal thread, and the other is provided with an external thread, so that the two are threadedly connected.

[0075] The inner tube 11 adopts a split design, which allows for adjustment of the distance between the ablation unit 2 and the collection unit 3 to match different ablation requirements, and also allows for adjustment of the position of the valve body 4 in the inner tube 11, further expanding the applicability of the ablation device 100. On the other hand, compared with the method of setting the valve body 4 in an integral inner tube, the valve body 4 in this method can enter from the proximal end of the second tube section 11b and be connected or fixed, which greatly reduces the difficulty of setting the valve body and thus reduces the manufacturing cost.

[0076] Figure 5 for Figure 2 A magnified structural diagram of region A in the middle.

[0077] In some embodiments, the outer periphery of the proximal end of the inner tube 11 is provided with a spiral groove 112 of a predetermined length and an elastic membrane 113 covering the spiral groove 112.

[0078] See Figure 2 and Figure 5 The inner tube 11 has a spiral groove 112 of a predetermined length and an elastic membrane 113 covering the spiral groove 112 on a section near the proximal end of the ablation unit 2. The engagement of the spiral groove 112 and the elastic membrane 113 not only ensures the sealing of the inner tube 11's cavity, allowing coolant to pass through without leakage, but also improves the compliance of the distal end of the ablation device, ensuring bending performance and facilitating the passage of the ablation device through tortuous vascular tissue. Optionally, the inner tube 11 is made of nickel-titanium alloy. Optionally, the elastic membrane 113 is made of silicone.

[0079] The ablation unit 2 needs to have foldable properties that can be expanded and folded together. The specific structure of the ablation unit 2 is described in detail below with reference to the attached drawings.

[0080] Figure 6 This is a schematic diagram of the ablation unit of an ablation device according to an embodiment of this application. Figure 7 for Figure 6 A schematic diagram of the ablation unit viewed along the axial direction.

[0081] In some embodiments, the ablation unit 2 includes a connecting rod 21 and a support frame 22 disposed at the distal end of the connecting rod 21. The connecting rod 21 is connected to the inner tube 11, and at least a portion of the connecting rod 21 is located between the inner tube 11 and the sheath 12. The support frame 22 includes a plurality of deformation units 221 arranged circumferentially around itself. The plurality of deformation units 221 are adjacent to each other and can deform independently relative to the adjacent deformation unit 221. An ablation electrode 20 is disposed at the distal end of each deformation unit 221.

[0082] The connecting rod 21 includes a plurality of connecting arms 211 spaced apart along its circumference, and the plurality of connecting arms 211 are connected one-to-one with the proximal ends of the plurality of deformation units 221; in the first state, the ablation unit 2 extends from the distal end of the sheath 12 so that the support frame 22 unfolds in a funnel shape.

[0083] See Figure 6 and Figure 7 The support frame 22 of the ablation unit 2 includes multiple deformation units 221 located on the distal side. The number of deformation units 221 can be two or more. Taking six deformation units 221 as an example, the six deformation units 221 are arranged around the support frame 22 in a circumferential manner. The six deformation units 221 are adjacent to each other and can deform independently relative to the adjacent deformation units 221, so that the ablation unit 2 can be fully expanded in a funnel shape or gathered in the sheath 12.

[0084] When the ablation unit 2 is fully deployed, each deformation unit 221 is provided with two ablation electrodes 20 spaced apart. The multiple ablation electrodes 20 of the six deformation units 221 are arranged in a ring to achieve ring ablation.

[0085] When the connecting rod of the ablation unit is tubular, the ablation unit 2 is gathered inside the sheath 12. At least part of the connecting rod 21 at the proximal end of the ablation unit 2 will form a hard compression with the distal edge of the sheath 12. At this time, not only is it difficult for the ablation unit 2 to enter the sheath 12 and thus break at this point, but the movement of the multiple deformation units 221 of the ablation unit 2 at the distal end is also restricted, which is not conducive to the independent deformation of each deformation unit 221 and its gathering. This also causes the multiple deformation units 221 at the distal end of the ablation unit 2 to collide.

[0086] Therefore, in this embodiment, the connecting rod 21 includes multiple connecting arms 211 spaced apart along its circumference, and the multiple connecting arms 211 are connected to the proximal end of the support frame 22. This reduces the connection strength at the connection point between the connecting rod and the support frame 22, making it easier for the support frame 22 to enter the sheath 12 when the ablation unit 2 moves axially. Simultaneously, since each connecting arm 211 is independent of the others, and each independently spaced connecting arm 211 has a certain amount of circumferential space for movement, when the ablation unit 2 is radially constrained, the support frame 22 connected to it can move circumferentially through the connecting arms 211. This movement can further create a tendency for circumferential rotation into the sheath 12, allowing the support frame 22 to more easily and smoothly converge into the sheath 12. Furthermore, the circumferential movement of the connecting arms 211 is more conducive to driving the movement of the distal deformation units 221 and forming an interlaced shape, reducing the continuous apex at the distal end and facilitating convergence into the sheath 12.

[0087] Figure 8 for Figure 6 A magnified structural diagram of region B in the middle.

[0088] In some embodiments, each deformation unit 221 includes a first deformation portion 2211 and a second deformation portion 2212 connected circumferentially along the support frame 22. The first deformation portion 2211 of each deformation unit 221 is adjacent to the second deformation portion 2212 of the adjacent deformation unit 221. The support frame 22 also includes a plurality of main rods 222, which are spaced apart circumferentially along the support frame 22. The proximal end of each main rod 222 is connected to the free end of the connecting arm 211, and the distal end of each main rod 222 is simultaneously connected to the proximal ends of two adjacent first deformation portions 2211 and second deformation portions 2212 in two adjacent deformation units 221. There is a gap S between the proximal ends of the two adjacent first deformation portions 2211 and second deformation portions 2212 in two adjacent deformation units 221. The width of the gap S in the circumferential direction gradually decreases from the proximal end to the distal end.

[0089] See Figure 6 and Figure 8Multiple main rods 222 of the support frame 22 are spaced apart circumferentially along the support frame 22. The proximal end of each main rod 222 is connected to the free end of a corresponding connecting arm 211. The multiple connecting arms 211 are relatively independent of each other in the circumferential direction, which can facilitate the orderly deployment and retraction while forming effective support. Adjacent connecting arms 211 can move relative to each other. The distal end of each main rod 222 is simultaneously connected to the proximal ends of two adjacent first deformation parts 2211 and second deformation parts 2212 in two adjacent deformation units 221. This facilitates the movement of the edges of the distal first deformation parts 2211 and second deformation parts 2212, allowing each deformation unit 221 to deform individually and interlock with adjacent deformation units 221, thereby reducing the possibility of the distal end of the ablation unit 2 continuously abutting against each deformation unit 221, and also facilitating sheath retraction.

[0090] Furthermore, the diameter of the main rod 222 gradually decreases from the distal end to the proximal end, which has a certain guiding effect and is conducive to the staggered convergence of each deformation unit 221. At the same time, it is wider on the distal end side connected to the first deformation part 2211 and the second deformation part 2212, which can form a strong support and improve the radial force.

[0091] Furthermore, a gap S exists between the proximal ends of two adjacent first deformable portions 2211 and second deformable portions 2212 in two adjacent deformable units 221. The width of the gap S in the circumferential direction gradually decreases from the proximal end to the distal end, making the gap S approximately teardrop-shaped. This arrangement of the gap S increases the distance between the proximal ends of the first deformable portions 2211 and second deformable portions 2212, while decreasing the distance at the distal end, even forming an abutting state at the distal end. The purpose of this arrangement is twofold: first, it ensures that the first deformable part 2211 and the second deformable part 2212 have a large misalignment space on the proximal side, which is more conducive to folding and retracting into the sheath when subjected to radial constraint force, and is conducive to minimizing the outer diameter; second, it allows the first deformable part 2211 and the second deformable part 2212 to form a circumferential abutment or near abutment on the distal side, which is conducive to the two interacting with each other quickly to generate deformation and misalignment when subjected to radial constraint, and at the same time, it can maximize the unfolded circumference of the ablation unit 2. Third, the ablation electrode 20 is electrically connected to an external power source via the wire 5. When the wire 5 passes through the gap S, there is a relatively large space near the proximal end for the wire 5 to pass through. Simultaneously, since the wire 5 continues to extend and electrically connect to the ablation electrode 20 after passing through the gap S, it needs a certain amount of movement as the ablation unit 2 converges and expands. The circumferential width of the gap S gradually decreases from the proximal end to the distal end, preventing the wire 5 from forming a rigid contact with the support frame 22 at the gap S. During the movement of the ablation electrode 20 towards the distal end, the wire 5 extends towards the distal end through the through-hole in the gap S, allowing it to follow the ablation electrode 20 towards the distal end. This enables the wire 5 to adaptively conform to the converged ablation electrode 20, allowing for smoother movement even when it conforms to the inner / outer wall of the ablation unit 2 after passing through the relatively large space near the proximal end. Furthermore, the teardrop-shaped gap S also serves as a guide to some extent.

[0092] like Figure 6 and Figure 7 As shown, in other embodiments, a first threading hole 223 is provided on the connecting arm 211 at the distal end of the connecting rod 21 of the ablation unit 2, and a second threading hole 224 adjacent to the gap S is provided on the main rod 222. The gap S is located on the proximal side of the deformation unit 221, and the second threading hole 224 is located on the proximal side of the gap S. One end of the wire 5 is electrically connected to an external power supply, and the other end of the wire 5 passes through the space between the sheath 12 and the inner tube 11. The wire 5 is attached to the outer wall of the main rod 222 and extends toward the distal ablation electrode 20. Specifically, the wire 5 passes through the first threading hole 223 from the outer wall of the inner tube 11, then extends toward the gap S from the radially inner side of the support frame 22, passes through the second threading hole 224, passes through the gap S from the radially outer side of the main rod 222, enters the radially inner side of the deformation unit 221, and is then electrically connected to the ablation electrode 20.

[0093] In this way, by opening a gap S and a second wire hole 224 on the main rod 222 of the support frame 22, after the wire 5 passes through the gap S and the second wire hole 224, the gap S and the second wire hole 224 can limit the wire 5. Furthermore, since the gap S is located on the proximal side of the deformation unit 221, the wire 5 can bend towards the inner wall of the main rod 222 after passing through the gap S. This reduces the possibility that the wire 5 will get stuck between the first deformation part 2211 and the second deformation part 2212 during the process of being put into the sheath tube 12 or released from the sheath tube 12. This can prevent the wire 5 from being damaged by the cross friction between the first deformation part 2211 and the second deformation part 2212, thus avoiding damage to the insulation layer of the wire 5.

[0094] Preferably, the conductor 5 between the gap S and the second threading hole 224 is located on the outside of the main rod 222, while the rest are located on the inside. The length of the conductor 5 on the outside is shorter than the length of the conductor 5 on the inside. For example, the interval between the gap S and the second threading hole 224 is defined as <0.5mm. It should be noted that the gap S and the second threading hole 224 have a certain interval to provide bending space for the conductor 5. However, the interval between the gap S and the second threading hole 224 cannot be too large. When the interval between the gap S and the second threading hole 224 is too large, it is easy for a floating wire to form between the gap S and the second threading hole 224 during the process of the conductor 5 being drawn into the sheath 12, increasing the probability of the insulation layer of the conductor 5 being damaged by friction from the sheath 12. Therefore, by setting the interval between the gap S and the second threading hole 224 to <0.5mm, it is possible to provide a certain bending space for the conductor 5 while preventing the formation of a floating wire due to an excessively large distance between the gap S and the second threading hole 224.

[0095] The ablation device of this application can collect coolant during ablation and remove it after ablation, minimizing coolant entry into the lungs and preventing coolant accumulation in the bronchi that could cause other diseases. It also ensures that coolant is sprayed onto the electrodes during ablation, maintaining the flexibility of the sheath. Furthermore, the ablation unit and the collection unit can move synchronously, retracting into and releasing the sheath, making operation simple.

[0096] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. An ablation device, characterized by, include: A tube assembly includes an inner tube and a sheath sleeved outside the inner tube, wherein the inner tube is connected to a liquid supply device for supplying coolant to the inner tube; An ablation unit, sleeved on the distal end of the inner tube, has an ablation electrode arranged in a ring at its distal end. This ablation electrode is used to adhere to the inner wall of the target tissue and release ablation energy. A collection unit is connected to the distal end of the inner tube and axially spaced from the distal end of the ablation unit. The inner tube between the ablation unit and the collection unit is provided with a spray hole for spraying coolant onto the ablation electrode. The collection unit is used to collect the sprayed coolant.

2. The ablation device of claim 1, wherein, The collection unit includes a support tube and a self-deploying collection umbrella connected to the distal end of the support tube. The end of the support tube away from the collection umbrella is connected to the distal end of the inner tube. The collection umbrella includes a plurality of elastic rods spaced apart circumferentially along the support tube and a flexible membrane covering the plurality of elastic rods. The elastic rods are arc-shaped rods bent toward the proximal end of the inner tube.

3. The ablation device of claim 2, wherein, The support tube is provided with a suction hole that communicates with the inner tube.

4. The ablation device of claim 3, wherein, The inner tube is also equipped with a valve body, which is located between the spray hole and the suction hole. When the valve body is closed, the inner tube sprays coolant onto the ablation electrode through the spray hole. When the valve body is open, the collection unit draws the coolant collected by the collection umbrella into the inner tube through the suction hole.

5. The ablation device of claim 4, wherein, The valve body includes a screen, a blocking member, and a limiting member arranged sequentially along the axial direction of the inner tube. The screen is located at the far end of the spray hole. The limiting member has a through groove. The blocking member can move between the screen and the limiting member. When the blocking member moves to the limiting member and closes the through groove, the valve body is closed. When the blocking member moves to the screen, the valve body is open.

6. The ablation device of claim 4, wherein, The valve body is threadedly connected to the inner wall of the inner tube; And / or, the inner tube includes a first tube segment and a second tube segment arranged sequentially and connected along its own axial direction, the first tube segment being provided with the spray hole and connected to the ablation unit, the second tube segment being provided with the valve body and connected to the collection unit, and the distal end of the first tube segment being threadedly connected to the proximal end of the second tube segment.

7. The ablation device of claim 1, wherein, The inner tube has a spiral groove of a predetermined length and an elastic membrane covering the spiral groove on a section located near the ablation unit.

8. The ablation device according to any one of claims 1 to 7, characterized in that, The ablation unit and the collection unit are foldably disposed between the inner tube and the sheath. In the first state, the collection unit and the ablation unit can extend and unfold sequentially from the distal end of the sheath so that the ablation electrode can fit against the inner wall of the target tissue. At the same time, coolant is sprayed onto the ablation electrode through the spray hole, and the coolant sprayed from the spray hole is collected by the collection unit. In the second state, the ablation unit and the collection unit can retract sequentially toward the proximal end of the sheath so that the ablation unit and the collection unit are gathered together inside the sheath.

9. The ablation device according to claim 8, characterized in that, The ablation unit includes a connecting rod and a support frame disposed at the distal end of the connecting rod. The connecting rod is connected to the inner tube, and at least a portion of the connecting rod is located between the inner tube and the sheath. The support frame includes a plurality of deformation units arranged circumferentially around itself. The plurality of deformation units are adjacent to each other and can deform independently relative to the adjacent deformation unit. The ablation electrode is disposed at the distal end of each deformation unit. The connecting rod includes a plurality of connecting arms spaced apart along its circumference, and the plurality of connecting arms are connected one-to-one with the proximal ends of the plurality of deformation units; in the first state, the ablation unit extends from the distal end of the sheath to make the support frame unfold in a funnel shape.

10. The ablation device according to claim 9, characterized in that, Each of the deformation units includes a first deformation portion and a second deformation portion connected in the circumferential direction along the support frame, wherein the first deformation portion of each deformation unit and the second deformation portion of the adjacent deformation unit are adjacent to each other. The support frame also includes a plurality of main rods, which are spaced apart circumferentially along the support frame. The proximal end of each main rod is connected to the free end of the connecting arm, and the distal end of each main rod is simultaneously connected to the proximal ends of two adjacent first deformation parts and second deformation parts in two adjacent deformation units. There is a gap between the proximal ends of the first deformation portion and the second deformation portion in two adjacent deformation units, and the width of the gap gradually decreases from the proximal end to the distal end along the circumferential direction.

Images