Ablation device

Abstract

The ablation device comprises a sheath tube, a middle tube and an inner tube, and a first supporting unit is connected with the far end of the middle tube; the second supporting unit is connected with the far end of the inner tube; the ablation unit is connected between the first supporting unit and the second supporting unit; each of the first supporting unit and the second supporting unit has a first state capable of being self-unfolded and a second state capable of being gathered towards respective central shafts when being radially restrained; the middle tube can axially move and drive the first supporting unit located on the far-end side of the middle tube to extend out of the far end of the sheath tube and be self-unfolded, and the inner tube can axially move and drive the second supporting unit located on the far-end side of the inner tube to extend out of the far end of the sheath tube and be self-unfolded. The first supporting unit and the second supporting unit which are self-unfolded get close to each other or get away from each other along with relative movement of the middle tube and the inner tube, and the outer diameter of the ablation unit is increased or decreased in the process that the first supporting unit and the second supporting unit get close to each other or get away from each other. The invention aims to improve the wall adhesion of the ablation device and improve the ablation effect.

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] Because the morphology of the target tissue sites varies among different patients, such as the diameter of the bronchus, the ablation device may not adhere well to the inner wall of the target tissue, thus failing to achieve the expected ablation effect. Summary of the Invention

[0004] The purpose of this application is to provide an ablation device to solve the problem that existing ablation devices do not adhere to the target tissue as expected after deployment.

[0005] Therefore, this application provides an ablation device, comprising: a tube assembly including a sheath, a middle tube, and an inner tube sequentially sleeved from the outside to the inside, wherein the middle tube and the inner tube are axially movable relative to the sheath, and the distal end of the inner tube extends beyond the distal end of the middle tube; a first support unit connected to the distal end of the middle tube; a second support unit connected to the distal end of the inner tube; and an ablation unit connected between the first support unit and the second support unit; wherein the first support unit and the second support unit each have a first self-deploying state and a second state converging toward their respective central axes when radially constrained; the middle tube and a first support unit located at the distal end of the middle tube. The support unit, the inner tube, the second support unit located at the distal end of the inner tube, and the ablation unit located between the first support unit and the second support unit can all be housed within the sheath. The middle tube can move axially and drive the first support unit located at its distal end to extend from the distal end of the sheath and self-deploy. The inner tube can move axially and drive the second support unit located at its distal end to extend from the distal end of the sheath and self-deploy. The self-deployed first support unit and the second support unit move closer to or further away from each other with the relative movement of the middle tube and the inner tube. The outer diameter of the ablation unit increases or decreases as the first support unit and the second support unit move closer to or further away from each other.

[0006] In some embodiments of this application, the ablation device further includes a pushing component, the distal end of which is movably connected to the first support unit to adjust the deployed posture of the first support unit in the first state.

[0007] In some embodiments of this application, the first support unit includes a first support frame, the first support frame includes a plurality of first deformation units located on the distal side, the plurality of first deformation units are arranged circumferentially and connected to the proximal end of the ablation unit, the plurality of enclosed first deformation units are adjacent to each other and can deform independently relative to the adjacent first deformation unit.

[0008] The pushing component includes multiple support rods, each of which corresponds to a first deformation unit. Each support rod has an abutment portion for abutting against the proximal end face of the first deformation unit. In the first state, the abutment portion of each support rod abuts against its corresponding first deformation unit.

[0009] In some embodiments of this application, the distal end of the support rod is further provided with a winding portion, which moves through the first deformation unit and winds inward. When the support rod is retracted, the winding portion can gradually unfold so that the support rod can move axially backward relative to the first deformation unit.

[0010] In some embodiments of this application, the maximum outer diameter of the first support unit after unfolding in the first state is greater than the maximum outer diameter of the second support unit after unfolding.

[0011] In some embodiments of this application, the ablation unit includes a deformable braided mesh and electrodes disposed on the braided mesh. When the first support unit and the second support unit are close to each other, the braided mesh can be lantern-shaped.

[0012] In some embodiments of this application, the electrode includes a conductive layer disposed on the outer peripheral surface of the braided mesh; and / or conductive wires disposed on the outer peripheral surface of the braided mesh.

[0013] In some embodiments of this application, the ablation device further includes a pull wire, the distal end of which is connected to the ablation unit and / or the second support unit. When the pull wire is pulled, the ablation unit and the second support unit can converge inward together. As the first support unit and the second support unit approach each other, the inwardly converging ablation unit and the second support unit can be at least partially housed within the self-deploying first support unit.

[0014] In some embodiments of this application, the pull wire includes a first pull wire and / or a second pull wire, the distal end of the first pull wire being connected to the proximal end of the second support unit, and the distal end of the second pull wire being connected to the ablation unit.

[0015] In some embodiments of this application, when the ablation device includes a pushing component, the proximal end of the pull wire is connected to the pushing component and moves axially backward with the pushing component to pull the pull wire.

[0016] In some embodiments of this application, the distal end of the central tube includes a plurality of connecting arms, which are spaced apart along their circumference, and the distal ends of the plurality of connecting arms are respectively connected to the proximal ends of a plurality of first deformation units.

[0017] In some embodiments of this application, each first deformation unit includes a first deformation portion and a second deformation portion connected in the circumferential direction, and the first deformation portion of each first deformation unit is adjacent to the second deformation portion of the adjacent first deformation unit.

[0018] The first support frame also includes multiple main rods, which are spaced apart along their circumference. The proximal end of each main rod is connected to the distal 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 first deformation units.

[0019] In some embodiments of this application, there is a gap between the proximal ends of the two adjacent first deformation portions and the second deformation portion in two adjacent first deformation units, and the circumferential spacing of the gap gradually decreases along the extension direction from the proximal end to the distal end.

[0020] The ablation device in various embodiments of this application adjusts the unfolding shape of the ablation unit through the tube assembly and two self-deploying opposing support units, allowing it to adaptively adjust according to the shape of different target tissue sites, improving adhesion and ablation effect to achieve the expected results. Furthermore, to enhance adhesion, a pushing component is provided, enabling diversified adjustments for both overall and local areas, expanding the product's applicability. As the pushing component moves axially backward, a pull wire can be pulled simultaneously, causing the ablation unit and the second support unit to converge and be housed together within the first support unit. The structure is simple, and operation is convenient and quick.

[0021] 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

[0022] 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:

[0023] 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:

[0024] Figure 1 This is a schematic diagram of the structure of the first support unit, the ablation unit, and the second support unit of the ablation device according to an embodiment of this application when they are in a self-deploying state without radial constraints.

[0025] Figure 2 for Figure 1 The diagram shows the exploded structure of the ablation device.

[0026] Figure 3 This is a schematic diagram of the structure of the ablation unit of an ablation device according to an embodiment of this application when the shape changes;

[0027] Figure 4 for Figure 3 The diagram shows the exploded structure of the ablation device.

[0028] Figure 5 This is a schematic diagram showing the assembly effect of the first support unit and the pushing component of an ablation device according to an embodiment of this application.

[0029] Figure 6 This is a schematic diagram showing another assembly effect of the first support unit and the pushing component of the ablation device according to an embodiment of this application;

[0030] Figure 7 for Figure 6 A schematic diagram of the structure when the first support unit and the support rod abut against each other;

[0031] Figure 8 for Figure 6 A schematic diagram of the structure when the winding part unfolds as the middle support rod is retracted;

[0032] Figure 9 for Figure 6 A schematic diagram of the structure of the first supporting unit along an angle;

[0033] Figure 10 for Figure 6 A schematic diagram of the first support unit at another angle;

[0034] Figure 11 for Figure 10 A magnified structural diagram of region A in the middle.

[0035] The labels in the attached diagram are as follows:

[0036] 100. Ablation device;

[0037] 1. First support unit; 11. First support frame; 111. Main rod; 12. First deformation unit; 121. First deformation part; 122. Second deformation part; 123. Gap; 124. First wire hole; 125. Second wire hole;

[0038] 2. Second support unit; 21. Second support frame; 22. Second deformation unit;

[0039] 3. Ablation unit; 31. Braided mesh; 32. Electrode;

[0040] 4. Tube assembly; 41. Sheath; 42. Middle tube; 421. Connecting arm; 43. Inner tube;

[0041] 5. Pushing component; 51. Support rod; 52. Abutment part; 53. Winding part; 54. Main push rod; 55. Sub-push rod;

[0042] 6. Guy wire; 61. First guy wire; 62. Second guy wire; 7. Conductor wire. Detailed Implementation

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] Please see Figures 1 to 4 This application provides an ablation device 100, which includes at least a first support unit 1, a second support unit 2, an ablation unit 3, and a tube assembly 4.

[0052] The tube assembly 4 includes a sheath 41, a middle tube 42, and an inner tube 43, which are sequentially arranged from the outside to the inside. The distal end of the inner tube 43 extends beyond the distal end of the middle tube 42, meaning the distal end of the inner tube 43 is closer to the distal end than the middle tube 42. Both the middle tube 42 and the inner tube 43 can move axially relative to the sheath 41, and relative axial movement can also occur between the inner tube 43 and the middle tube 42. A first support unit 1 is located at the distal end of the middle tube 42 and connected to the distal end of the middle tube 42. A second support unit 2 is located at the distal end of the inner tube 43 and connected to the distal end of the inner tube 43. An ablation unit 3 is connected between the first support unit 1 and the second support unit 2, and the shape of the ablation unit 3 can be deformed.

[0053] The first support unit 1 and the second support unit 2 each have a first self-deploying state and a second state in which they converge toward the central axis OO of the ablation device when radially constrained. The middle tube 42 and the first support unit 1 located at the distal end of the middle tube 42, the inner tube 43 and the second support unit 2 located at the distal end of the inner tube 43, and the ablation unit 3 located between the first support unit 1 and the second support unit 2 can all be housed within the sheath tube 41. The "first state" described herein refers to the state in which the first support unit and the second support unit are naturally deployed without radial constraint, in which no external force or operation has been applied to the first support unit and the second support unit.

[0054] The middle tube 42 can move axially and drive the first support unit 1 located on its distal side to extend from the distal end of the sheath 41, causing the first support unit 1 to self-deploy. The inner tube 43 can move axially and drive the second support unit 2 located on its distal side to extend from the distal end of the sheath, causing the second support unit 2 to self-deploy. The self-deployed first support unit 1 and the second support unit 2 move closer to or further away from each other with the relative movement of the middle tube 42 and the inner tube 43. During the process of the first support unit 1 and the second support unit 2 moving closer to or further away from each other, the outer diameter of the ablation unit 3 increases or decreases, thereby changing the outer peripheral shape of the ablation unit 3 to improve the adhesion of the ablation device to the target tissue when it is deployed, thereby achieving the expected ablation effect.

[0055] After completion, the middle tube 42 and inner tube 43 are moved backward or the sheath tube 41 is moved forward again, so that the middle tube 42, the first support unit 1 connected to the distal end of the middle tube 42, the inner tube 43 and the second support unit 2 located at the distal end of the inner tube 43, and the ablation unit 3 located between the first support unit 1 and the second support unit 2 are all re-accommodated in the sheath tube 41.

[0056] In this embodiment, the ablation unit 3 has a predetermined shape, and the shape of the ablation unit 3 is deformable. The change in the shape of the ablation unit 3 is achieved through the first support unit 1, the second support unit 2, and the tube assembly 4 connected to it. The unfolded shape of the ablation unit 3 changes with the distance between the second support unit 2 and the first support unit 1. The changing unfolded shape of the ablation unit 3 will adapt to the shape of the target tissue site as much as possible. For example, if the inner diameter of the target tissue site is larger, the distance and the degree of unfolding of the support units can be adjusted to make the ablation unit 3 unfold larger. If the inner diameter of the target tissue site is smaller, the circumferential shape of the ablation unit 3 will be adaptively reduced, so that the ablation unit 3 can adaptively adjust its adhesion to the target tissue according to the shape of different target tissue sites, thereby improving the ablation effect.

[0057] The ablation unit 3 of the ablation device 100 is gathered in the sheath 41 before being delivered to the target position. After reaching the target position, the ablation unit 3 is released. After exiting the sheath, the ablation unit 3 unfolds. As the first support unit 1 and the second support unit 2 move closer or further apart, the outer diameter of the ablation unit 3 increases or decreases, causing the peripheral morphology of the ablation unit 3 to change so that it can adhere to the inner wall of the target tissue, such as the bronchus. Then, by releasing ablation energy, the parasympathetic nerves on the outer wall of the bronchus are 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.

[0058] Optionally, the first support unit 1, the second support unit 2, and the ablation unit 3 can be heat-set to give each a preset self-expanding shape and deformation capability. Each component can return to its preset shape when the sheath tube 41 is pushed out. That is, the first support unit 1, the second support unit 2, and the ablation unit 3 can self-expand into a preset shape when they are not constrained.

[0059] Please combine Figures 1-4 as well as Figure 5 As shown, in order to further adjust the unfolding posture of the self-deploying first support unit 1, in some embodiments, the ablation device 100 further includes a pushing component 5. The distal end of the pushing component 5 is movably connected to the first support unit 1. By pushing the pushing component 5 further forward, the unfolding posture of the first support unit 1 in the first state can be adjusted to partially or completely change the outer periphery shape of the ablation unit 3 connected thereto, thereby further partially or completely adjusting the wall adhesion effect.

[0060] In addition to the aforementioned functions, the first support unit 1 is connected to the central tube 42. During the process where the central tube 42 drives the first support unit 1 to extend and unfold from the distal end of the sheath 41, if the first support unit 1 does not fully unfold itself, i.e., does not reach the preset shape, it will directly affect the unfolding degree and ablation effect of the ablation unit 3. At this time, the first support unit 1 can be unfolded by pushing the push component 5; that is, the push component 5 can further assist the first support unit 1 in fully unfolding itself.

[0061] When the ablation unit 3 does not achieve the expected deployment effect or the local wall adhesion is poor, such as when the ablation unit 3 does not adhere well to the wall of the bronchus, the wall adhesion effect of the ablation unit 3 can be changed by adjusting the inner tube 43, the middle tube 42 and the pushing component 5. Pushing the middle tube 42 causes the first support unit 1 to move along the distal end of the sheath 41, causing the ablation unit 3, which is gathered together, to deploy along the axial direction of the sheath 41. Pushing the pushing component 5 applies a radial deployment force to the first support unit 1, causing the ablation unit 3 to deploy radially along the sheath 41. At this time, slightly pulling the inner tube 43 can adjust the outer diameter of the ablation unit 3 to change the wall adhesion effect.

[0062] Please see Figures 4-8In some embodiments, the first support unit 1 includes a first support frame 11, which includes a plurality of first deformation units 12 located on the distal side. The plurality of first deformation units 12 are arranged circumferentially and connected to the proximal end of the ablation unit 3. The plurality of enclosed first deformation units 12 are adjacent to each other and can deform independently relative to the adjacent first deformation unit 12. The pushing component 5 includes a plurality of support rods 51, which correspond one-to-one with the plurality of first deformation units 12. The end of the support rod 51 away from the central tube 42 is provided with an abutment portion 52 for abutting against the proximal end face of the first deformation unit 12. In the first state, the abutment portion 52 of each support rod 51 abuts against its corresponding first deformation unit 12, so that the first support frame 11 unfolds in a funnel shape. The support rods 51 can be pushed forward to adjust the unfolding posture of the first deformation unit 12 in the first state, so as to partially or completely change the outer peripheral shape of the ablation unit 3 connected thereto, thereby further partially or completely adjusting the wall adhesion effect. For example, if the adhesion effect at the location of one or more first deformation units 12 is poor, the support rod 51 connected to it can be adjusted to adjust the ablation unit 3 at the connection with the first deformation unit 12. In this embodiment, the multiple first deformation units 12 are independently deformed, and the support rods 51 are set one-to-one with them. This not only takes into account the deformability of the first support unit 1, ensuring its self-expansion and easy retraction, but also allows for overall or partial adjustment of the expansion degree of the first support unit 1, thereby realizing overall or partial adjustment of the ablation unit 3, improving overall or partial adhesion, and enhancing the ablation effect. The adjustment method of this embodiment is more flexible and has better product adaptability.

[0063] Continue reading Figure 5 The first support frame 11 of the first support unit 1 includes a plurality of first deformation units 12 located on the distal side. The number of first deformation units 12 can be two or more. Taking six first deformation units 12 as an example, the six first deformation units 12 are arranged in a circumferential manner and connected to the proximal end of the ablation unit 3. The six enclosed first deformation units 12 are adjacent to each other and can deform independently relative to the adjacent first deformation unit 12, so that the first support unit 1 can be expanded and converged.

[0064] The pushing component 5 includes multiple support rods 51, each corresponding to a first deformation unit 12. The central tube 42 pushes the first support unit 1 towards the distal end of the sheath 41, causing the first support frame 11 to gradually unfold and further push the support rods 51 forward, so that the abutment portion 52 on the support rod 51 can abut against its corresponding first deformation unit 12. Then, according to the adjustment needs, the support rods 51 are pushed partially or entirely, causing the first deformation unit 12 to expand further, thereby adjusting the partial or overall shape of the ablation unit 3. The fully unfolded state of the multiple first deformation units 12 of the first support frame 11 is generally funnel-shaped. When they are not fully unfolded after being freed from the constraint of the sheath, they can also be opened to the fully unfolded funnel state with the help of the support rods 51.

[0065] Reference Figure 5 As shown, the proximal ends of multiple support rods 51 can be connected to a main push rod 54 simultaneously. The main push rod 54 is housed in the sheath tube 41. The push and pull of multiple support rods 51 are achieved by moving the main push rod 54 back and forth relative to the sheath tube 41. In this way, the simultaneous control of multiple support rods 51 is realized, and overall adjustment can be performed.

[0066] Reference Figure 6 As shown, in order to further achieve local adjustment, the proximal ends of multiple support rods 51 are connected to multiple sub-push rods 55 one by one. Each support rod 51 can be independently controlled by a sub-push rod 55. Pushing a sub-push rod 55 will cause the corresponding support rod 51 to expand outward, pushing a certain first deformation unit 12 of the first support unit 1 to unfold, increasing the wall-adhering force of the first deformation unit 12 and the magnitude of its contact force with the inner wall of the target tissue, thereby achieving local adjustment. Of course, when overall adjustment is required, multiple sub-push rods 55 can be moved simultaneously.

[0067] In one embodiment, the push rod is housed within the sheath 41. An annular flange may be provided on the outer periphery of the central tube 42. Multiple through holes are provided along the circumferential direction of the annular flange. The proximal end of each sub-push rod 55 passes through a through hole, and the distal end of each sub-push rod 55 is connected to a corresponding support rod 51. This allows for independent adjustment of the circumferential expansion degree of any of the first deformation units 12, thereby adjusting the expansion degree and shape of the corresponding position of the ablation unit 3. In another embodiment, the main push rod 54 and the sub-push rods 55 may be sleeved between the central tube 42 and the inner tube 43, and they may move axially.

[0068] Combination Figure 5 , Figure 6 as well as Figure 7 and Figure 8As shown, in some embodiments, the far end of the support rod 51 away from the central tube 42 is also provided with a winding portion 53. The winding portion 53 moves through the first deformation unit 12 and winds inward. When the support rod 51 is retracted, the winding portion 53 can gradually unfold so that the support rod 51 can move axially backward relative to the first deformation unit 12.

[0069] As previously described, the abutting portion 52 of the support rod 51 can abut against the corresponding first deformation unit 12 and push the first deformation unit 12 to expand outward. To prevent the first deformation unit 12 from detaching from the support rod 51 during unfolding, a winding portion 53 is provided at the distal end of the support rod 51. The winding portion 53 moves through the first deformation unit 12 and winds inward, preventing detachment while avoiding damage to the tissue wall during pushing. Optionally, the support rod 51 is made of nickel-aluminum alloy, and the thickness of the winding portion 53 is thinner than the thickness of the rest of the support rod 51, allowing the winding portion 53 to undergo elastic deformation.

[0070] like Figure 8 As shown, the pushing component 5 moves toward the proximal end of the sheath 41. At this time, a portion of the winding portion 53 of the support rod 51 unfolds, and the support rod 51 can move axially backward relative to the first deformation unit 12. The support rod 51 can then reassemble and retract into the sheath 41.

[0071] In some embodiments, the ablation unit 3 includes a deformable braided mesh 31 and an electrode 32 disposed on the braided mesh 31. When the first support unit 1 and the second support unit 2 are close to each other, the braided mesh 31 can be spread outward in a lantern shape.

[0072] Optionally, the braided mesh 31 is made of nickel-aluminum alloy. Optionally, the electrode 32 is made of a conductive metal, such as gold. The braided mesh 31 has a mesh structure, which is prone to elastic deformation, enabling it to unfold and converge. When unfolded, the braided mesh 31 expands outward in a lantern shape, which can increase the contact area and contact force between the ablation unit 3 and the inner wall of the target tissue, further improving the adhesion effect between the electrode 32 and the target tissue.

[0073] In some embodiments, electrode 32 is a conductive layer formed on the outer peripheral surface of braided mesh 31; or electrode 32 is a conductive wire inserted into the outer peripheral surface of braided mesh 31.

[0074] In one example, electrode 32 is a conductive layer formed on the outer peripheral surface of the braided mesh 31. The surface of the conductive layer is gold-plated to improve conductivity. Thus, any part of the conductive layer can be electrically connected to an external power source via a wire, making the entire outer peripheral surface of the braided mesh 31 conductive, increasing the contact area between electrode 32 and the inner wall of the target tissue. In another example, electrode 32 is a conductive wire inserted into the outer peripheral surface of the braided mesh 31. The braided mesh 31 is entirely insulated, serving only to fix the conductive wire. The conductive wire can be made of at least one of gold, tungsten, and copper. The conductive wire is electrically connected to an external power source via a wire. When the braided mesh 31 is spread outward in a lantern shape, the conductive wire on the outer peripheral surface of the braided mesh 31 can contact the inner wall of the target tissue, achieving circumferential ablation.

[0075] In some embodiments, refer to Figures 2-4 As shown, the second support unit 2 includes a second support frame 21, which includes a plurality of second deformation units 22 located on the proximal side. The plurality of second deformation units 22 are arranged circumferentially and connected to the distal end of the ablation unit 3. The plurality of enclosed second deformation units 22 are adjacent to each other and can deform independently relative to the adjacent second deformation unit 22. In the first self-deployed state, the second support frame 21 is in the shape of an inverted funnel. The structure of the second support unit 2 is similar to that of the first support unit 1 and will not be described again.

[0076] To facilitate the re-entry of the support unit and ablation unit after deployment, at least a portion of the second support unit 2 and the ablation unit 3 can be first housed within the deployed first support unit 1. Then, the middle tube 42 and inner tube 43 can be moved backward or the sheath tube 41 can be moved forward to retract the first support unit 1, the ablation unit 3, and the second support unit 2 into the sheath tube 41. This method simplifies the overall structure of the ablation device 100, facilitates its fabrication, and makes the deployment and retraction of the ablation unit 3 easier to achieve.

[0077] In some embodiments, in the first state, the maximum outer diameter of the first support unit 1 after unfolding is greater than the maximum outer diameter of the second support unit 2 after unfolding. The proximal end of the ablation unit 3 is connected to the first support unit 1, and the distal end of the ablation unit 3 is connected to the second support unit 2. After the ablation unit 3 is unfolded, the maximum outer diameter of the end connected to the first support unit 1 is greater than the maximum outer diameter of the end connected to the second support unit 2. Before closing the sheath, the inner tube 43 is moved so that the second support unit 2 and the ablation unit 3 are gathered inside the first support unit 1, and then the first support unit 1, the ablation unit 3, and the second support unit 2 are gathered and closed inside the sheath tube 41.

[0078] More specifically, in the first state, the maximum outer diameter of the distal side of the first support frame 11 after unfolding is greater than the maximum outer diameter of the proximal side of the second support frame 21 after unfolding. That is, the maximum outer diameter of the structure formed by the circumferential enclosure of the multiple first deformation units 12 is greater than the maximum outer diameter of the structure formed by the circumferential enclosure of the multiple second deformation units 22. In this way, the unfolded multiple second deformation units 22, together with the ablation unit 3, can be gathered together within the structure formed by the enclosure of the multiple first deformation units 12.

[0079] Please see Figure 2 As shown, based on any of the above embodiments, the ablation device 100 further includes a pull wire 6, the distal end of which is connected to the ablation unit 3 and / or the second support unit 2. When the pull wire 6 is pulled, the ablation unit 3 and the second support unit 2 can converge inward together. As the first support unit 1 and the second support unit 2 approach each other, the ablation unit 3 and the second support unit 2 that converge inward can be at least partially housed within the self-deploying first support unit 1.

[0080] like Figure 2 As shown, in one example, the distal end of the pull wire 6 is connected to the ablation unit 3; optionally, the distal end of the pull wire 6 is connected to the middle of the ablation unit 3 along the axial direction. In another example, the distal end of the pull wire 6 is connected to the second support unit 2. In yet another example, the distal end of the pull wire 6 is connected to both the ablation unit 3 and the second support unit 2. Pulling the pull wire 6 pulls the middle of the ablation unit 3 and / or the second support unit 2, causing the ablation unit 3 and the second support unit 2 to converge inward, bringing the distal ends of the inner tube 43 and the middle tube 42 closer together. The ablation unit 3 and the second support unit 2 fold and converge inside the first support unit 1. Keeping the middle tube 42 and the inner tube 43 in place, the sheath 41 is pushed forward, causing the first support unit 1, and the ablation unit 3 and the second support unit 2, which are at least partially enclosed within the first support unit 1, to enter the sheath 41 together, completing the sheath retraction.

[0081] For example, such as Figure 2 As shown, the pull wire 6 includes a first pull wire 61 and / or a second pull wire 62. The distal end of the first pull wire 61 is connected to the ablation unit 3, and the distal end of the second pull wire 62 is connected to the second support unit 2. To prevent the ablation unit 3 and the second support unit 2 from overlapping and becoming difficult to converge during the pulling process, the pull wire 6 is divided into a first pull wire 61 and a second pull wire 62. The distal end of the first pull wire 61 is connected to the ablation unit 3, and the distal end of the second pull wire 62 is connected to the second support unit 2, which facilitates the adjustment of the expansion and convergence degree of the ablation unit 3 and the second support unit 2.

[0082] The proximal end of the pull wire 6 can extend out of the sheath 41. Preferably, when the ablation device 100 includes the aforementioned push component 5, the proximal end of the pull wire 6 is connected to the push component 5 and moves backward along the axial direction of the push component 5 to simultaneously pull the pull wire 6. That is, while the push component 5 is retracted, the pull wire 6 gathers and accommodates the ablation unit 3 and the second support unit 2 together in the first support unit 1, so that they can be further retracted into the sheath 41.

[0083] like Figure 2 The pull line 6 is connected to the support rod 51 of the push component 5 at its proximal end. It is not necessary to pull the pull line 6 separately. Simply pull the push component backward so that the support rod 51 can drive the pull line 6 together with the ablation unit 3 and the second support unit 2 to gather together in the first support unit 1, and then gather them in the sheath tube 41. In this way, two results can be achieved in one operation. The operation is simple and quick. More importantly, the pull response speed is faster and less effort is required, and the gathering effect is better.

[0084] In some embodiments, refer to Figure 10 The distal end of the central tube 42 includes multiple connecting arms 421, which are circumferentially spaced along the central axis of the central tube 42. The free ends of the multiple connecting arms 421 are respectively connected to the proximal ends of multiple first deformation units 12.

[0085] like Figure 6 and Figure 9 As shown, when the first support unit 1 converges into the sheath 41, the proximal end of the first support unit 1 will form a hard compression with the distal edge of the sheath 41. At this time, not only is it difficult for the first support unit 1 to enter the sheath 41 and thus break at this point, but the movement of the multiple first deformation units 12 of the first support unit 1 at the distal end is also restricted, which is not conducive to the independent deformation and convergence of each first deformation unit 12. This also causes the multiple first deformation units 12 at the distal end of the first support unit 1 to collide, making it difficult for the first support unit 1 to enter the sheath.

[0086] Therefore, in this embodiment, multiple connecting arms 421 at the distal end of the central tube 42 are circumferentially spaced along the central axis of the central tube 42, and the multiple connecting arms 421 are connected to the proximal end of the first support unit 1. Compared with the method of connecting the tubular end to the first support unit 1, this embodiment connects multiple circumferentially spaced connecting arms 421 to the first support unit 1. When the first support unit 1 moves axially into the sheath tube 41, the strength at the connection point is reduced, making it easier to insert the sheath. At the same time, since each connecting arm 421 is independent of each other, each independently spaced connecting arm 421 has a certain amount of room for movement in the circumferential direction. When the first support unit 1 is radially constrained, the connecting arms 421 connected to it can move in the circumferential direction, and this movement can further form a tendency for circumferential rotation to insert the sheath, making it easier and smoother for the first support unit 1 to insert the sheath. In addition, the circumferential movement of the connecting arms 421 is more conducive to driving the movement of the distal deformation unit and forming an interlaced shape, thereby further reducing the problem of continuous collision at the distal end.

[0087] In some embodiments, each first deformation unit 12 includes a first deformation portion 121 and a second deformation portion 122 connected circumferentially, and the first deformation portion 121 of each first deformation unit 12 and the second deformation portion 122 of the adjacent first deformation unit 12 are adjacent to each other; the first support frame 11 also includes a plurality of main rods 111, which are spaced apart circumferentially, the proximal end of each main rod 111 is connected to the free end of the connecting arm 421, and the distal end of each main rod 111 is simultaneously connected to the proximal ends of two adjacent first deformation portions 121 and second deformation portions 122 in two adjacent first deformation units 12.

[0088] like Figures 9 to 11 As shown, the first support frame 11 has multiple main rods 111 arranged circumferentially. The proximal end of each main rod 111 is connected to the free end of a corresponding connecting arm 421. The multiple connecting arms 421 are relatively independent of each other in the circumferential direction, which can facilitate convergence and ensure orderliness during convergence while forming effective support. Adjacent connecting arms 421 can move relative to each other. The distal end of each main rod 111 is simultaneously connected to the proximal ends of two adjacent first deformation parts 121 and second deformation parts 122 in two adjacent first deformation units 12. This facilitates the movement of the edges of the distal first deformation parts 121 and second deformation parts 122, allowing each first deformation unit 12 to deform individually and converge with adjacent first deformation units 12 in an alternating manner. This reduces the possibility of the distal end of the first support unit 1 continuously abutting against each first deformation unit 12, making it easier to retract the sheath.

[0089] Furthermore, the diameter of the main rod 111 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 first deformation unit 12. At the same time, it is wider at the distal end connected to the first deformation part 121 and the second deformation part 122, which can form a strong support and improve the radial force.

[0090] See also Figures 9-11 In some embodiments, there is a gap 123 between the proximal sides of the two adjacent first deformation portions 121 and the second deformation portion 122 in the two adjacent first deformation units 12, and the circumferential spacing of the gap 123 gradually decreases along the extension direction from the proximal end to the distal end.

[0091] The circumferential spacing of the gap 123 gradually decreases from the proximal end to the distal end, making the gap 123 roughly teardrop-shaped. This arrangement of the gap 123 results in a large distance between the proximal ends of the first deformable part 121 and the second deformable part 122, and a small distance between the distal ends, even forming an abutment at the distal end. The purpose of this arrangement is twofold: first, it ensures a large misalignment space between the first deformable part 121 and the second deformable part 122 on the proximal end, which is more conducive to misaligned folding and sheathing under radial constraint, and facilitates the minimization of the outer diameter; second, it allows the first deformable part 121 and the second deformable part 122 to form a circumferential abutment or near abutment on the distal end, which facilitates their rapid interaction and deformation and misalignment under radial constraint, and also maximizes the unfolded circumference of the first support unit 1. Third, when the wire 7 passes through the gap 123, the larger space at the proximal end allows the wire 7 to pass through. Simultaneously, since the wire 7 continues to extend and electrically connect with the electrode 32 after passing through the gap 123, it needs a certain amount of movement as the first support unit 1 converges and expands. The gradually decreasing circumferential spacing of the gap 123 from the proximal end to the distal end avoids a rigid contact between the wire 7 and the first support frame 11 at the gap 123. During the movement of the electrode 32 towards the distal end, the wire 7 extends towards the distal end through the through-hole of the gap 123, allowing it to follow the electrode 32 towards the distal end. This enables the wire 7 to adaptively conform to the displacement of the converged electrode 32, allowing it to move more smoothly even when it is in contact with the inner / outer wall of the first support unit 1 after passing through the larger space at the proximal end. Furthermore, the teardrop-shaped gap 123 also serves as a guide to some extent.

[0092] like Figure 11As shown, in other embodiments, a first wire hole 124 is provided on the connecting arm 421 at the distal end of the middle tube 42, and a second wire hole 125 adjacent to the gap 123 is provided on the main rod 111. The gap 123 is located on the distal side of the first deformation unit 12, and the second wire hole 125 is located on the proximal side of the gap 123. One end of the wire 7 is electrically connected to an external power supply, and the other end of the wire 7 passes through the space between the sheath 41 and the middle tube 42. The wire 7 is attached to the outer wall of the first support unit 1 and extends toward the distal end of the first support unit 1. The wire 7 passes through the first wire hole 124 from the outer wall of the middle tube 42, and then extends toward the gap 123 from the radially inner side of the first support unit 1. After passing through the second wire hole 125, it passes through the gap 123 from the radially outer side of the first support unit 1 and enters the radially inner side of the first support unit 1, and then connects to the electrode 32.

[0093] In this way, by opening a gap 123 and a second through hole 125 on the first support unit 1, after the wire 7 passes through the gap 123 and the second through hole 125, the gap 123 and the second through hole 125 can limit the wire 7. Furthermore, since the gap 123 is located on the proximal side of the first deformation unit 12, the wire 7 can be bent towards the wall after passing through the gap 123. This reduces the possibility that the wire 7 will get caught between the first deformation part 121 and the second deformation part 122 during the process of being put into the sheath tube 41 or released from the sheath tube 41. This can prevent the wire 7 from being damaged by the cross friction between the first deformation part 121 and the second deformation part 122, thus avoiding damage to the insulation layer of the wire 7.

[0094] Preferably, the conductor 7 between the gap 123 and the second threading hole 125 is located on the outer side of the first support unit 1, while the rest are located on the inner side. The length of the conductor 7 located on the outer side is shorter than the length of the conductor 7 located on the inner side. For example, the interval between the gap 123 and the second threading hole 125 is defined as <0.5mm. It should be noted that there is a certain interval between the gap 123 and the second threading hole 125, which is used to provide bending space for the conductor 7 to be threaded. However, the interval between the gap 123 and the second threading hole 125 cannot be too large. When the interval between the gap 123 and the second threading hole 125 is too large, it is easy for the conductor 7 to form a floating line between the gap 123 and the second threading hole 125 during the sheathing process, which increases the probability that the insulation layer of the conductor 7 will be damaged by friction from the sheath tube 41. Therefore, by setting the interval between the gap 123 and the second wire hole 125 to be less than 0.5mm, it is possible to provide a certain space for wire bending while preventing the gap 123 and the second wire hole 125 from being too large and causing the wire 7 to form a floating wire.

[0095] The ablation device of this application adjusts the deployment shape of the ablation unit through a tube assembly and two self-deploying opposing support units, allowing it to adaptively adjust according to the shape of different target tissue sites, improving adhesion and ablation effect to achieve the expected results. Furthermore, to enhance adhesion, a push component is provided, enabling diversified adjustments for both overall and localized areas, expanding the product's applicability. As the push component moves axially backward, it simultaneously pulls a pull wire, which in turn draws the ablation unit and the second support unit together, converging and housing them within the first support unit. The structure is simple, and operation is convenient and quick.

[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 in that, include: The tube assembly includes a sheath, a middle tube, and an inner tube that are sequentially sleeved from the outside to the inside. Both the middle tube and the inner tube can move axially relative to the sheath, and the distal end of the inner tube extends beyond the distal end of the middle tube. The first support unit is connected to the distal end of the central tube; The second support unit is connected to the distal end of the inner tube; as well as An ablation unit is connected between the first support unit and the second support unit; The first support unit and the second support unit each have a first self-deploying state and a second state that converges toward their respective central axes when radially constrained; the middle tube and the first support unit located at the distal end of the middle tube, the inner tube and the second support unit located at the distal end of the inner tube, and the ablation unit located between the first support unit and the second support unit can all be housed within the sheath. The middle tube can move axially and drive the first support unit located at its distal end to extend from the distal end of the sheath and unfold itself. The inner tube can move axially and drive the second support unit located at its distal end to extend from the distal end of the sheath and unfold itself. The unfolded first support unit and second support unit move closer to or further away from each other with the relative movement of the middle tube and the inner tube. The outer diameter of the ablation unit increases or decreases as the first support unit and the second support unit move closer to or further away from each other.

2. The ablation device according to claim 1, characterized in that, The ablation device further includes a pushing component, the distal end of which is movably connected to the first support unit to adjust the unfolded posture of the first support unit in the first state.

3. The ablation device according to claim 2, characterized in that, The first support unit includes a first support frame, which includes a plurality of first deformation units located on the distal side. The plurality of first deformation units are arranged circumferentially and connected to the proximal end of the ablation unit. The plurality of enclosed first deformation units are adjacent to each other and can deform independently relative to the adjacent first deformation unit. The pushing component includes multiple support rods, each of which corresponds to a plurality of the first deformation units. Each support rod has an abutment portion for abutting against the proximal end face of the first deformation unit. In the first state, the abutment portion of each support rod abuts against its respective first deformation unit.

4. The ablation device according to claim 3, characterized in that, The distal end of the support rod is also provided with a winding portion, which moves through the first deformation unit and winds inward. When the support rod is retracted, the winding portion can gradually unfold so that the support rod can move axially backward relative to the first deformation unit.

5. The ablation device according to claim 1, characterized in that, In the first state, the maximum outer diameter of the first support unit after unfolding is greater than the maximum outer diameter of the second support unit after unfolding.

6. The ablation device according to claim 1, characterized in that, The ablation unit includes a deformable woven mesh and electrodes disposed on the woven mesh. When the first support unit and the second support unit are close to each other, the woven mesh can take the shape of a lantern.

7. The ablation device according to claim 6, characterized in that, The electrode comprises a conductive layer disposed on the outer peripheral surface of the braided mesh; and / or conductive lines disposed on the outer peripheral surface of the braided mesh.

8. The ablation device according to any one of claims 1 to 7, characterized in that, The ablation device also includes a pull wire, the distal end of which is connected to the ablation unit and / or the second support unit. When the pull wire is pulled, the ablation unit and the second support unit can converge inwards together. As the first support unit and the second support unit approach each other, the ablation unit and the second support unit that converge inwards can be at least partially housed within the self-deploying first support unit.

9. The ablation device according to claim 8, characterized in that, The pull wires include a first pull wire and / or a second pull wire, the distal end of the first pull wire being connected to the proximal end of the second support unit, and the distal end of the second pull wire being connected to the ablation unit.

10. The ablation device according to claim 8, characterized in that, When the ablation device includes a pushing component, the proximal end of the pull wire is connected to the pushing component and moves axially backward with the pushing component to pull the pull wire.

11. The ablation device according to claim 3, characterized in that, The distal end of the central tube includes multiple connecting arms, which are spaced apart circumferentially, and the distal ends of the multiple connecting arms are respectively connected to the proximal ends of the multiple first deformation units.

12. The ablation device according to claim 11, characterized in that, Each of the first deformation units includes a first deformation portion and a second deformation portion connected in the circumferential direction, and the first deformation portion of each first deformation unit is adjacent to the second deformation portion of the adjacent first deformation unit. The first support frame also includes a plurality of main rods, which are spaced apart along their circumference. The proximal end of each main rod is connected to the distal 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 portions and second deformation portions in two adjacent first deformation units.

13. The ablation device according to claim 12, characterized in that, There is a gap between the proximal ends of the two adjacent first deformation portions and the second deformation portion in two adjacent first deformation units, and the circumferential spacing of the gap gradually decreases along the extension direction from the proximal end to the distal end.

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