Ablation device

Abstract

The present application relates to a kind of ablation devices, comprising: catheter and with the ablation part of catheter distal end connection, the ablation part has inflatable performance, and including multiple ablation components, each ablation component includes support unit, wall unit and the energy release unit on the wall unit;Multiple support units are radiated outward and extend to the distal end direction of the ablation part to be connected with multiple wall units;When the ablation part is in natural inflation state, at least one wall unit in the ablation part can be independently deformed relative to adjacent wall unit.The ablation device of the present application can adapt to target tissue morphology, and realize good adhesion with target tissue.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates 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. Its main characteristics are persistent airflow limitation and corresponding respiratory symptoms, with the primary pathological manifestation being airway and / or alveolar abnormalities. As the disease progresses, shortness of breath may become noticeable during non-strenuous activities such as walking. Over time, COPD symptoms may appear with progressively lower activity levels until they are present at all times, severely limiting a person's ability to perform normal activities. Lung disease is often characterized by airway obstruction, airway wall thickening, changes in the structure within or around the airway walls, or a combination thereof. Airway obstruction can significantly reduce gas exchange in the lungs, causing shortness of breath. Airway obstruction can be caused by excessive intraluminal mucus or edema fluid, or both. Airway wall thickening may be caused by excessive contraction of airway smooth muscle, airway smooth muscle hypertrophy, mucous gland hyperplasia, inflammation, edema, or a combination thereof. Structural changes around the airways, such as damage to the lung tissue itself, can lead to loss of radial constriction of the airway walls and subsequent airway narrowing. Asthma and COPD are serious diseases with an increasing number of patients.

[0003] Targeted Lung Denervation (TLD) is a relatively new trend in COPD treatment. TLD ablation primarily uses an ablation device to release ablation energy to ablate the parasympathetic nerves in the bronchial epicardium, thereby blocking nerve signal transmission. This relaxes the airway smooth muscle, reduces mucus secretion, and thus improves symptoms of airway obstruction and dyspnea. Please refer to [link to relevant documentation]. Figure 1 , Figure 1 This diagram illustrates the typical anatomical structure of the airway (also known as the trachea). The airway is primarily composed of cartilage, smooth muscle fibers, and connective tissue. The cartilage 11 of the airway is C-shaped, with its opening facing the esophagus 13. There are generally 14 to 16 cartilages 11 in the airway, spaced apart along the length of the airway, and connected by annular ligaments. The posterior wall membrane 12, formed by smooth muscle fibers and connective tissue, closes the opening of the cartilage 11. This posterior wall membrane 12 is relatively flat, making the cross-section of the airway inner wall roughly D-shaped. The C-shaped region occupies approximately two-thirds of the airway's cross-sectional circumference, while the relatively flat posterior wall membrane 12 occupies approximately one-third of the airway's cross-sectional circumference. Figure 2A schematic cross-sectional view of an existing ablation device deployed in the trachea is shown. The ablation device includes a catheter and an electrode (not shown) located at the distal end of the catheter. The distal end of the catheter forms an annular structure 1 with an opening. Because the annular structure 1 has an opening, it can deform to a certain extent under the radial pressure of the airway wall. However, since the annular structure 1 is a one-piece structure, when a certain area of ​​the annular structure 1 is deformed by radial pressure, it will inevitably cause the adjacent area to deform as well. This results in the annular structure 1 being unable to fit well into the non-circular contour of the target tissue, and consequently, the ablation energy of the electrode located on the annular structure 1 cannot be well transferred to the target tissue. Summary of the Invention

[0004] The purpose of this invention is to provide an ablation device that can adapt to the morphology of the target tissue and achieve good adhesion to the target tissue.

[0005] This objective is achieved through the following methods:

[0006] A first aspect of the present invention provides an ablation device comprising: a catheter and an ablation portion connected to the distal end of the catheter, the ablation portion having expandable properties and comprising a plurality of ablation components, each of the ablation components comprising a support unit, a wall-adhering unit, and an energy release unit disposed on the wall-adhering unit; the plurality of support units are radially extended outward and extend toward the distal end of the ablation portion to connect with the plurality of wall-adhering units; when the ablation portion is in a naturally expanded state, at least one wall-adhering unit in the ablation portion can deform independently relative to its adjacent wall-adhering unit.

[0007] In one embodiment, a plurality of the support units are arranged to form a cavity with an opening at the distal end, and a plurality of the wall-adhering units are arranged at intervals around the opening.

[0008] In one embodiment, the wall-adhering unit includes a first connecting end and a second connecting end connected to the support unit, and a deformable segment extending between the first connecting end and the second connecting end. The deformable segment has elastic deformation properties, and when the ablation part is in a naturally expanded state, the deformable segment bends and protrudes relative to the first connecting end and the second connecting end toward the outside of the ablation part.

[0009] In one embodiment, when the deformable segment is subjected to a force toward the inside of the ablation portion, the deformable segment can undergo elastic deformation to increase the distance between the first connecting end and the second connecting end.

[0010] In one embodiment, the deformable segment includes a first wall-attached segment and a second wall-attached segment. One end of the first wall-attached segment is connected to the first connecting end, and the other end of the first wall-attached segment is connected to one end of the second wall-attached segment. The other end of the second wall-attached segment is connected to the second connecting end. The first connecting end and the second connecting end can move closer to each other under the action of an external force and move further apart when the external force is removed.

[0011] In one embodiment, both the first and second wall-adhering segments include an arc-shaped structure protruding outwards from the ablation region; or, both the first and second wall-adhering segments include a straight structure inclined outwards from the ablation region; or, one of the first and second wall-adhering segments includes an arc-shaped structure protruding outwards from the ablation region, and the other includes a straight structure inclined outwards from the ablation region.

[0012] In one embodiment, the deformable segment further includes a connecting segment, the connecting segment including a distal vertex and a first connecting arm and a second connecting arm that jointly connect the distal vertex, a gap existing between the proximal ends of the first connecting arm and the proximal ends of the second connecting arm, one end of the first wall-attached segment connecting to the first connecting end, the other end of the first wall-attached segment connecting to the first connecting arm, one end of the second wall-attached segment connecting to the second connecting arm, and the other end of the second wall-attached segment connecting to the second connecting end.

[0013] In one embodiment, the connecting segment protrudes toward the distal end of the ablation device.

[0014] In one embodiment, the support unit includes two spaced-apart first support rods, with the first connecting end and the second connecting end respectively fixedly connected to one of the first support rods.

[0015] In one embodiment, the ablation unit further includes a support member comprising a plurality of spaced-apart second support rods, the proximal end of each second support rod being fixedly connected to the catheter, and the distal end of each second support unit being fixedly connected to two adjacent first support units.

[0016] In one embodiment, the support unit includes a straight section and is connected to the wall-attached unit through the straight section. In the natural expansion state, the angle between the straight section and the axis of the ablation part is smaller than the angle between the remaining area of ​​the support unit (excluding the straight section) and the axis of the ablation part.

[0017] In one embodiment, the ablation device has a first region and a second region, wherein the wall-adhering units in the first region can deform independently relative to the adjacent wall-adhering units, and the wall-adhering units in the first region and the second region are approximately located on the same plane, or the wall-adhering units in the first region and the second region are located on different planes.

[0018] In one embodiment, the wall-adhering unit of the first region is located between the wall-adhering unit of the second region and the catheter, and when both the first region and the second region are subjected to a force in the direction toward the inside of the ablation portion, at least one wall-adhering unit in the second region abuts against the inside of the wall-adhering unit in the first region.

[0019] In one embodiment, the energy release unit located in the first region includes an electrode pair and / or a strip electrode, wherein the electrode pair includes a first electrode and a second electrode with opposite polarities, the first electrode and the second electrode being disposed at intervals on one or more of the wall-mounted units; the strip electrode extends along the length direction of the wall-mounted unit.

[0020] In one embodiment, the wall-attached unit includes a sheet-like mesh structure, the mesh structure including conductive wires, the exposed conductive wires forming mesh electrodes.

[0021] In one embodiment, the catheter and the ablation section have interconnected delivery channels; and / or, the distal end of the catheter is provided with an extension tube, the extension tube passing through the ablation section, and the catheter and the extension tube are provided with interconnected delivery channels; the surface of the ablation section and / or the extension tube is provided with a first cooling hole, the first cooling hole connecting the delivery channel to the outside, the delivery channel being used to deliver a cooling medium, and the first cooling hole being used to release the cooling medium to the outside.

[0022] In one embodiment, the ablation device further includes a cooling balloon, which includes a balloon body having an inner cavity and a delivery channel communicating with the inner cavity. The balloon body is disposed in the inner cavity of the ablation part, and when the balloon body is in an inflated state, the outer surface of the balloon body is in contact with the wall-adhering unit. The delivery channel is used to deliver a cooling medium to the inner cavity of the balloon. The surface of the cooling balloon is provided with one or more second cooling holes, which are used to communicate the inner cavity of the balloon with the outside and to discharge the cooling medium in the inner cavity of the balloon to the outside.

[0023] In one embodiment, the cooling balloon further includes a recovery channel communicating with the inner cavity of the balloon, the recovery channel being used to recover the cooling medium in the inner cavity of the balloon.

[0024] The present invention also proposes a cooling balloon, comprising: an inflatable balloon body, a delivery channel, and a retrieval channel; wherein, the balloon body includes a first balloon cavity and a second balloon cavity arranged radially, and the delivery channel, the retrieval channel, the first balloon cavity, and the second balloon cavity form a cooling circuit for the flow of cooling medium; the first balloon cavity has a first outer wall, and the second balloon cavity has a second outer wall, the first outer wall and the second outer wall being arranged circumferentially along the balloon body; any cross-sectional area of ​​the first balloon cavity within the axial region where the first outer wall is located is a first cross-sectional area, and any cross-sectional area of ​​the second balloon cavity within the axial region where the second outer wall is located is a second cross-sectional area, wherein the first cross-sectional area is larger than the second cross-sectional area.

[0025] In one embodiment, the cooling balloon further includes an outer tube, a separator, and an output port; the distal end of the outer tube is connected to the proximal end of the balloon body, the outer tube is a multi-lumen tube, and the interior of the outer tube has independent delivery channels and recovery channels; one of the first balloon cavity and the second balloon cavity is connected to the distal end of the delivery channel, and the other is connected to the distal end of the recovery channel; the proximal end of the delivery channel is used to connect to an external cooling device, and the proximal end of the recovery channel is used to connect to an external recovery device; the separator is fixedly connected inside the balloon body and is disposed between the first balloon cavity and the second balloon cavity, for separating the first balloon cavity and the second balloon cavity; at least one output port is provided between the first balloon cavity and the second balloon cavity, the output port connecting the first balloon cavity and the second balloon cavity, for allowing the cooling medium to flow between the first balloon cavity and the second balloon cavity.

[0026] In one embodiment, the separator includes a sheet-like structure extending from the proximal end to the distal end of the balloon body to separate the first balloon cavity and the second balloon cavity, and in any cross-section of the balloon body within the axial region where the separator is located, the cross-sectional area occupied by the first balloon cavity is greater than the cross-sectional area occupied by the second balloon cavity.

[0027] In one embodiment, the separator further includes an inner balloon, with a cooling cavity formed between the outer surface of the inner balloon and the inner surface of the balloon body, the sheet-like structure located in the cooling cavity, and separating the first balloon cavity and the second balloon cavity from the cooling cavity.

[0028] In one embodiment, the cooling balloon further includes an inner rod, and the outer tube is provided with a receiving cavity. The inner rod passes through the receiving cavity, and the distal end of the inner rod extends into the inner cavity of the balloon and is fixedly connected to the distal end of the balloon body.

[0029] In one embodiment, the output port is located on the separator and / or the inner rod, and the distance from the output port to the distal end of the balloon body is less than the distance from the output port to the proximal end of the balloon body.

[0030] In one embodiment, the delivery channel includes a first delivery channel and a second delivery channel, and the recovery channel includes a first recovery channel and a second recovery channel. The first delivery channel, the first recovery channel, and the first balloon cavity form a first cooling circuit, and the second delivery channel, the second recovery channel, and the second balloon cavity form a second cooling circuit. When the first balloon cavity and the second balloon cavity are in an inflated state, the flow rate of the cooling medium in the axial region where the second outer wall is located in the second balloon cavity is greater than the flow rate of the cooling medium in the axial region where the first outer wall is located in the first balloon cavity.

[0031] In one embodiment, the surface roughness of the inner surface of the second outer wall is less than the surface roughness of the inner surface of the first outer wall.

[0032] In one embodiment, the outer surface hardness of the second outer wall is less than that of the first outer wall.

[0033] In one embodiment, the balloon body is provided with cooling pipes, and the density of the cooling pipes on the first outer wall is less than the density of the cooling pipes on the second outer wall.

[0034] The ablation device provided by the present invention has at least one deformable wall-adhering unit in the ablation section. When the ablation section is deployed in the airway, the deformable unit can deform independently relative to the adjacent wall-adhering unit when subjected to the compressive force of the inner wall of the airway. This avoids interference with the adjacent wall-adhering unit when the deformable unit deforms, thereby allowing each area of ​​the ablation section to better adapt to the shape of the inner wall of the airway and thus improve the wall-adherence of the ablation device to the target tissue. Attached Figure Description

[0035] 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 invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein:

[0036] Figure 1 This is a typical anatomical structure of the airway;

[0037] Figure 2 This is a schematic diagram of the ablation device deployed in the airway in the prior art.

[0038] Figure 3 This is a schematic diagram of the ablation device in Embodiment 1 of the present invention;

[0039] Figure 4 for Figure 3 A schematic diagram of the structure in which the ablation zone is in a state of natural expansion;

[0040] Figure 5 for Figure 4 Side view of the ablation zone;

[0041] Figure 6 for Figure 4 Schematic diagram of the deformation of the ablation zone under the action of force;

[0042] Figure 7 for Figure 4 A schematic diagram of the deformation of a wall-mounted unit under the action of force;

[0043] Figure 8 for Figure 4 Schematic diagram of electrode arrangement in the middle ablation zone;

[0044] Figure 9 for Figure 4 Another schematic diagram of electrode arrangement in the ablation zone;

[0045] Figure 10 This is a partial structural schematic diagram of the ablation device in Embodiment 2 of the present invention;

[0046] Figure 11 for Figure 10 Schematic diagram of the deformation of the ablation zone under the action of force;

[0047] Figure 12 This is a partial structural schematic diagram of the ablation device in Embodiment 3 of the present invention;

[0048] Figure 13 This is a partial structural schematic diagram of the ablation device in Embodiment 4 of the present invention;

[0049] Figure 14 for Figure 13 A schematic diagram of the cross-section of the ablation component;

[0050] Figure 15 for Figure 13 A schematic diagram of the cross-section of the central support component;

[0051] Figure 16 This is a partial structural schematic diagram of an ablation device according to another embodiment of the present invention;

[0052] Figure 17 This is a partial structural schematic diagram of the ablation device in Embodiment 5 of the present invention;

[0053] Figure 18 for Figure 17 Schematic diagram of the structure of the intermediate cooling balloon;

[0054] Figure 19 This is a partial structural schematic diagram of the ablation device in another embodiment of the present invention;

[0055] Figure 20 This is a partial structural diagram of the cooling balloon in Embodiment 6 of the present invention;

[0056] Figure 21 This is a partial structural diagram of the cooling balloon in Embodiment 7 of the present invention;

[0057] Figure 22 This is a partial structural diagram of the cooling balloon in another embodiment of the present invention;

[0058] Figure 23 This is a partial structural schematic diagram of the cooling balloon in Embodiment 8 of the present invention;

[0059] Figure 24 This is a schematic cross-sectional view of the middle region of the cooling balloon in another embodiment of the present invention;

[0060] Figure 25 This is a partial structural diagram of the cooling balloon in Embodiment 9 of the present invention;

[0061] Figure 26 for Figure 25 A schematic diagram of the planar unfolding of the area surrounding the intermediate cooling sphere. Detailed Implementation

[0062] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can 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 the invention and to fully convey the scope of the invention to those skilled in the art.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] To more clearly describe the structure of the ablation device, the terms "proximal" and "distal" are used here as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the procedure, and "proximal" refers to the end closest to the operator during the procedure.

[0067] Example 1

[0068] Reference Figure 3 This embodiment provides an ablation device 20, which is used to release ablation energy to target tissue to substantially alter the electrical shape, mechanical properties, chemical properties, or other properties of the target tissue. For ease of understanding, this embodiment is described using pulmonary nerve ablation as an application scenario, but the application scenarios of the ablation device 20 of the present invention are not limited to this, and can also be applied in a variety of different environments, such as the ablation of tissues such as renal arteries, pulmonary veins, left atrial appendages, and ventricles.

[0069] The ablation device 20 of this embodiment includes a conduit 21, an ablation section 22, and an operating handle 230. The conduit 21 may be a tubular structure, with its proximal end connected to the operating handle 230 and its distal end connected to the ablation section 22. The operating handle 230 is equipped with a circuit connector (not shown) for connection to an energy generator (not shown). This energy generator generates ablation energy, which includes, but is not limited to, thermal energy, cold energy, electrical energy, acoustic energy, radio frequency energy, pulsed high-voltage energy, mechanical energy, ionizing radiation, optical energy, and combinations thereof, as well as other types of energy suitable for treating tissue. In this embodiment, the energy generator is a radio frequency generator, capable of outputting radio frequency energy at the desired frequency. In other embodiments, any other suitable type of energy generator may be selected. The ablation section 22 has expandable properties; it can be radially compressed under external force and, after the external force is removed, self-expands and returns to its natural expanded state (i.e., its natural unfolded state without artificial external force). During ablation, the catheter 21 and ablation section 22 are housed within a delivery sheath (not shown). The catheter 21 and ablation section 22 are delivered into the airway through the delivery sheath. The delivery sheath is then withdrawn to release the ablation section 22, allowing it to expand and unfold within the airway. An energy generator controls the ablation section 22 to output ablation energy to ablate the parasympathetic nerves in the bronchial epicondyle, thereby blocking the transmission of nerve signals. After ablation is completed, the energy generator is operated to stop the output of ablation energy, and the catheter 21 and ablation section 22 are withdrawn back into the delivery sheath and then removed from the body along with the delivery sheath.

[0070] Reference Figure 4 , Figure 4This is a schematic diagram of the ablation unit 22 in its naturally expanded state according to this embodiment. In its naturally expanded state, the ablation unit 22 includes an ablation member 22a and a support member 22b. The proximal end of the support member 22b is connected to the distal end of the catheter 21, and the distal end of the support member 22b is connected to the ablation member 22a. The ablation unit 22 has a first region A1 and a second region A2. The first region A1 is used to adhere to and ablate the relatively flat posterior wall membrane 12 in the airway, and the second region A2 is used to adhere to and ablate the C-shaped region of the airway. Exemplarily, in this embodiment, the ablation unit 22 includes a total of 6 ablation members 22a, with two ablation members 22a located in the first region A1 and the other four ablation members 22a located in the second region A2. In other embodiments, the ablation unit 22 includes a total of 3 ablation members 22a, with one ablation member 22a located in the first region A1 and the other two ablation members 22a located in the second region A2. Alternatively, the ablation section 22 may include a total of four ablation components 22a, with one ablation component 22a located in the first region A1 and the other three ablation components 22a located in the second region A2. The specific number of ablation components 22a can be selected according to the actual application scenario, and the present invention is not limited in this regard.

[0071] In this embodiment, the plurality of ablation components 22a of the ablation section 22 are arranged radially and spaced apart toward the distal end of the catheter 21 to form a cone-shaped structure. Please also refer to Figure 5 Each ablation component 22a includes a support unit 24, a wall-adhering unit 23, and an energy release unit disposed on the wall-adhering unit 23. The proximal end of the support unit 24 of the plurality of ablation components 22a is connected to the conduit 21 via a support member 22b, and extends toward the distal end of the ablation section 22 to connect with the plurality of wall-adhering units 23.

[0072] For example, the support units 24 of the six ablation components 22a extend radially outward to enclose a cavity with an opening at its distal end. Each support unit 24 of the ablation component 22a includes two spaced-apart first support rods 241, the distal ends of which are fixedly connected to the wall-attached unit 23 of the ablation component 22a by welding, bonding, or other means. The angle (i.e., the outward tilt angle) between each first support rod 241 and the axis of the ablation section 22 is approximately equal, ranging from 25° to 75°. In other embodiments, the number of first support rods 241 in the support unit 24 of each ablation component 22a is not limited to two; it can be one or more than two, and the number of first support rods 241 in the support unit 24 of different ablation components 22a may vary. The support unit 24 in this embodiment can not only provide stable support for the wall-adhering unit 23 in the axial direction and reduce the axial displacement of the wall-adhering unit 23 after the ablation section 22 is deployed, but also provide the wall-adhering unit 23 with a force toward the outside of the ablation section 22 (toward the outside of the ablation section 22 means toward the radially outward direction away from the central axis of the ablation section 22, and toward the inside of the ablation section 22 means toward the radially inward direction close to the central axis of the ablation section 22, the same below), so that the wall-adhering unit 23 can adhere tightly to the inner wall of the target tissue (e.g., airway) to perform ablation operations.

[0073] The support member 22b of this embodiment includes multiple second support rods 221. The proximal end of each second support rod 221 is fixedly connected to the distal end of the catheter 21, and the distal end of each second support rod 221 is fixedly connected to the proximal end of a first support rod 241. For example, the support member 22b of this embodiment includes six second support rods 221. The angles (i.e., outward tilting angles) between the six second support rods 221 and the axis of the ablation section 22 are approximately equal, ranging from 25° to 75°. Each second support rod 221 is connected to the proximal ends of two adjacent first support rods 241 in two adjacent ablation members 22a. The two first support rods 241 connected to the same second support rod 221 can extend parallel to each other or in different non-parallel directions. Regardless of the extension direction of the two first support rods 241, a gap must be maintained between the distal ends of the two first support rods 241 to allow for a certain amount of movement between their distal ends. The second support rod 221 in this embodiment improves the support strength of the support unit 24. Furthermore, during the loading of the ablation section 22 into the delivery sheath, by pulling the catheter 21 located within the delivery sheath proximally, the ablation section 22 located outside the distal port of the delivery sheath moves proximally. The distal port of the delivery sheath applies a radial compressive force to the ablation section 22, thereby compressing it. During this process, the second support rod 221 guides the first support rod 241 to fold regularly, making the ablation section 22 easier to compress radially. Understandably, in other embodiments, the support member 22b can be a mesh structure formed by cutting or weaving, which is tubular; or, the support member 22b can also be a tubular structure formed by multiple interconnected wave coils arranged axially. In other embodiments, the support member 22b can be omitted, and the proximal end of the support unit 24 of the ablation member 22a can be directly fixedly connected to the distal end of the catheter 21.

[0074] In this embodiment, to ensure that the support unit 24 and the support member 22b can maintain their natural expansion shape, the support unit 24 and the support member 22b can be made of an elastic metal material through heat setting. The elastic metal material includes known materials used in implanted medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloys, or other biocompatible elastic metal materials. For example, in this embodiment, both the support unit 24 and the support member 22b are made of nickel-titanium alloy. In other embodiments, the support unit 24 and the support member 22b can be made of different materials.

[0075] In this embodiment, each ablation component 22a includes a wall-adhering unit 23. The wall-adhering units 23 of the plurality of ablation components 22a are generally located in the same radial plane (a plane perpendicular to the axis) and are arranged around the opening formed by the plurality of support units 24. Each wall-adhering unit 23 extends along the edge of the opening to form a generally annular structure for adhering to the inner wall of the target tissue (e.g., airway).

[0076] Please refer to the following at the same time Figure 5 , 6 In this embodiment, the multiple wall-adhering units 23 have approximately the same shape, structure, and size, and are spaced apart. All are deformable units, and when subjected to force (e.g., a force F acting towards the inside of the ablation section 22), they can deform independently relative to their adjacent wall-adhering units 23. In other embodiments, the wall-adhering units 23 adjacent to the rear wall membrane 12 can be deformable units, while the remaining wall-adhering units 23 are non-deformable. The specific shape, structure, and size of each wall-adhering unit 23 can be selected as needed.

[0077] For example, the wall-mounted unit 23 can be an elongated component, including a first connecting end 231, a second connecting end 232, and a deformable segment extending between the first connecting end 231 and the second connecting end 232. The first connecting end 231 and the second connecting end 232 are used to connect to two adjacent support units 24, respectively. For example, the first connecting end 231 is connected to the distal end of one of the first support rods 241 of the first support unit 24a, and the second connecting end 232 is connected to the distal end of one of the first support rods 241 of the second support unit 24b. In this embodiment, the first connecting end 231 and the second connecting end 232 are the head end and the tail end of the wall-mounted unit 23. In other embodiments, the first connecting end 231 and the second connecting end 232 can be located at any position between the head end and the tail end of the wall-mounted unit 23. In this embodiment, the first connecting end 231 and the second connecting end 232 of the deformable segment are both connected to the support unit 24. When the ablation part 22 unfolds in the airway, due to its outward expansion performance, the support unit 24 can drive the first connecting end 231 and the second connecting end 232 on the wall-adhering unit 23 to press against the inner wall of the airway. This allows the deformable segment located between the first connecting end 231 and the second connecting end 232 to contact the inner wall of the airway as much as possible, preventing the deformable segment from moving inward as a whole when squeezed by the inner wall of the airway, thus preventing some areas from contacting the inner wall of the airway.

[0078] The deformable segment bends and protrudes outward from the ablation portion 22 relative to the first connecting end 231 and the second connecting end 232, and has deformable properties, allowing it to undergo elastic deformation when subjected to external force. To ensure that the wall-adhering unit 23 has good elastic deformation properties, the deformable segment in this embodiment is made of nickel-titanium alloy. In other embodiments, the deformable segment can be made of any one or more of the above-mentioned elastic metal materials through heat setting. Because the deformable segment bends and protrudes outward from the ablation portion 22 and has elastic deformation properties, when the first connecting end 231 and the second connecting end 232 are driven by the support unit 24 to press against the inner wall of the airway, the deformable segment can be squeezed and deformed into a relatively straight shape by the rear wall membrane portion 12 to fit tightly against the inner wall of the rear wall membrane portion 12.

[0079] For example, the deformable segment includes a first wall-adhering segment 233 and a second wall-adhering segment 234. One end of the first wall-adhering segment 233 is connected to a first connecting end 231, and the other end of the first wall-adhering segment 233 is connected to one end of the second wall-adhering segment 234. The other end of the second wall-adhering segment 234 is connected to a second connecting end 232. The first wall-adhering segment 233 includes a first arc-shaped structure protruding outwards from the ablation portion 22, and the second wall-adhering segment 234 includes a second arc-shaped structure protruding outwards from the ablation portion 22. In other embodiments, the first wall-adhering segment 233 and the second wall-adhering segment 234 may further include a straight structure inclined outwards from the ablation portion 22, and the first wall-adhering segment 233 and the second wall-adhering segment 234 form an angle ranging from 175° to 185°.

[0080] To facilitate folding of the deformable section during sheathing (i.e., inclusion in the delivery sheath), a connecting section 235 may be provided between the first wall-mounted section 233 and the second wall-mounted section 234. For example, the connecting section 235 includes a distal vertex 2351 and a first connecting arm 2352 and a second connecting arm 2353 that jointly connect the distal vertex 2351. A gap exists between the proximal ends of the first connecting arm 2352 and the second connecting arm 2353. One end of the first wall-mounted section 233 is connected to the first connecting end 231, and the other end of the first wall-mounted section 233 is connected to the first connecting arm 2352. One end of the second wall-mounted section 234 is connected to the second connecting arm 2353, and the other end of the second wall-mounted section 234 is connected to the second connecting end 231. For example, the distal vertex 2351, the first connecting arm 2352, and the second connecting arm 2353 form a third arc-shaped structure. This third arc-shaped structure can be made of an elastic metal material, and the curvature of the third arc-shaped structure is greater than the curvature of the first arc-shaped structure and the curvature of the second arc-shaped structure. During the sheathing process, the first connecting end 231 and the second connecting end 232 are subjected to opposing compressive forces and move closer to each other. The first wall-attached segment 233 and the second wall-attached segment 234 also move closer to each other and fold. The third arc-shaped structure with a larger curvature bends more, making the wall-attached unit 23 easier to fold. In other embodiments, the distal vertex 2351, the first connecting arm 2352, and the second connecting arm 2353 can also form an inverted "V"-shaped structure, and the included angle of the inverted "V"-shaped structure is smaller than the included angle between the first wall-attached segment 233 and the second wall-attached segment 234, for example, less than or equal to 175°. It should be noted that in this embodiment, the connecting segment 235 protrudes towards the distal end. The term "towards the distal end" here is not limited to being parallel to the central axis of the catheter 21; it can also be inclined to a certain extent towards the inner or outer side of the ablation section 22, as long as the direction of the protrusion of the connecting segment 235 points distally. The distally protruding connecting segment 235 not only facilitates guiding the wall-adhering unit 23 to fold into a straight structure extending distally, but also prevents the protruding tip from contacting the airway inner wall after the ablation section 22 is unfolded, thereby effectively reducing damage and irritation to the airway inner wall caused by the connecting segment 235. Understandably, in other embodiments, the connecting segment 235 may also protrude in other directions, and this invention is not limited to this.

[0081] Please refer to this again. Figure 2 There is still a "dead zone" region 14 between the annular ablation device 20 and the "D"-shaped airway wall, where they cannot adhere properly. To ablate the parasympathetic nerve corresponding to this "dead zone" region 14, other electrodes that adhere to the airway wall need to be positioned further away. Figure 2The ablation energy released by the electrode 25 (not shown) increases, thereby expanding the ablation energy field it generates to cover the "dead zone" region 14 to achieve ablation of the "dead zone" region 14. However, as the ablation energy released by the electrode 25 increases, the larger ablation energy field generated can easily cover the esophagus 13 located near the posterior wall membrane 12, thereby causing irreversible damage to the esophagus 13.

[0082] Reference Figure 7 , Figure 8 Compared to Figure 2 In this embodiment, the wall-adhering unit 23, with its medium-circular ring structure 1, can deform independently to form a relatively flat structure when squeezed by the posterior wall membrane 12. This allows it to fit tightly against the posterior wall membrane 12, so that the electrode 25 on the wall-adhering unit 23 can release uniform ablation energy to the posterior wall membrane 12. This achieves ablation of the target tissue while avoiding damage to the epithelial tissue of the posterior wall membrane 12 and the nearby esophagus 13.

[0083] In this embodiment, the energy release unit is connected to the energy generator and applies the ablation energy output by the energy generator to the target tissue. The energy release unit includes multiple electrodes 25. These electrodes 25 can be one or more of the following: monopolar electrodes, bipolar electrodes, metal electrodes, strip electrodes, needle electrodes, or any other suitable electrode type. The arrangement and number of electrodes 25 can be determined by the type of electrode, electrode size, and the range of the desired ablation area. After one ablation, the ablation areas created by the electrodes 25 can overlap to form a closed loop in the circumferential direction, thereby maximally blocking the transmission of pulmonary nerve signals.

[0084] For example, the ablation section 22 has a total of 12 electrodes 25, all of which are monopolar electrodes. Two electrodes are provided on each wall-adhering unit 23, respectively located on the first wall-adhering section 233 and the second wall-adhering section 234. The electrodes 25 are evenly spaced to ensure that the ablation device 20 of this embodiment forms a uniform and continuous annular ablation zone at a certain depth in the target tissue, thereby maximally blocking the transmission of nerve signals. The electrodes 25 are generally tubular and are fitted onto the outer surface of the wall-adhering unit 23. An insulating layer, such as Pebax, PTFE, or Pyrelin, can also be provided between the electrodes 25 and the wall-adhering unit 23. This insulating layer effectively prevents the conductivity of the wall-adhering unit 23 from interfering with the radio frequency and feedback circuits.

[0085] Reference Figure 9In other embodiments, the first region A1 of the ablation section 22 includes at least one electrode pair, which includes a first electrode 25a and a second electrode 25b. The first electrode 25a and the second electrode 25b have opposite polarities; for example, the first electrode 25a is a positive electrode and the second electrode 25b is a negative electrode. Both the first electrode 25a and the second electrode 25b are electrically connected to the energy generator. In the first region A1, the first electrode 25a and the second electrode 25b are respectively disposed on two adjacent wall-mounted units 23. When the energy generator outputs ablation energy to the first electrode 25a and the second electrode 25b, a relatively flat ablation energy field is generated between the first electrode 25a and the second electrode 25b. Figure 9 The area marked by the dashed line in the middle produces a correspondingly longer and shallower damage area. This contrasts with the narrower and deeper damage area produced by a monopolar electrode. Figure 8 (The area marked by the dashed line in the middle) In this embodiment, the electrode pair 25 in the first region A1 can ablate the posterior wall membrane 12 while avoiding damage to the epithelial tissue of the posterior wall membrane 12 and the nearby esophagus 13. In other embodiments, the above-mentioned electrode pair 25 can be replaced with a strip electrode. The strip electrode can be made of metal material and extend along the length direction of the wall-attached unit 23. The strip electrode can also generate a relatively flat ablation energy field, thus avoiding damage to the epithelial tissue of the posterior wall membrane 12 and the nearby esophagus 13.

[0086] A sensor may also be installed inside electrode 25 to control the energy output and ablation effect during the ablation process. The sensor can be placed where electrode 25 contacts the airway wall to provide as accurate a report as possible on energy changes in the ablation zone. Depending on the specific requirements, the sensor can collect parameters such as temperature, pressure, and impedance. In other embodiments, the sensor may be omitted.

[0087] The ablation device 20 may also include wires with an insulating layer on their surface. Wires can be connected inside the electrode 25 by welding or other methods, and corresponding wires can also be connected to the sensor. In this embodiment, the wall-adhering unit 23, the support unit 24, the support member 22b, and the conduit 21 all have interconnected internal cavities. The wires of the electrode 25 and the sensor can be introduced into the internal cavity of the wall-adhering unit 23 through corresponding through holes. The wires of multiple electrodes 25 and sensors can converge inside the wall-adhering unit 23, pass through its internal cavity, and then through the internal cavities of the support unit 24, the support structure, and the conduit 21 to reach the operating handle 230 and connect to the circuit connector. In this embodiment, the internal cavities of the wall-adhering unit 23, the support unit 24, the support structure, and the conduit 21 provide constraint and protection for the wires. In other embodiments, the internal cavity of any one of the wall-adhering unit 23, the support unit 24, and the conduit 21 may be omitted, and the wires may also extend along the surface of the wall-adhering unit 23, the support unit 24, the support structure, and the conduit 21 and communicate with the circuit connector in the operating handle 230.

[0088] Example 2

[0089] Reference Figure 10 , 11 This embodiment is largely the same as the ablation device 20 in Embodiment 1. The similarities will not be repeated. The difference is that in this embodiment, the wall-adhering unit 23 of the first region A1 and the wall-adhering unit 23 of the second region A2 are located on different planes. When both the first region A1 and the second region A2 are subjected to a force (e.g., a radially inward force F) toward the inside of the ablation part 22, at least a portion of the second region A2 can abut against the inside of the wall-adhering unit 23 in the first region A1 to apply an outward force to the wall-adhering unit 23 of the first region A1.

[0090] For example, when the ablation unit 22 of this embodiment is in a naturally expanded state, the wall-adhering unit 23 in the first region A1 and the wall-adhering unit 23 in the second region A2 have approximately the same shape and size, and the wall-adhering unit 23 in the first region A1 is located between the wall-adhering unit 23 in the second region A2 and the catheter 21, that is, the axial distance from the wall-adhering unit 23 in the first region A1 to the catheter 21 is less than the axial distance from the wall-adhering unit 23 in the second region A2 to the catheter 21. Furthermore, the angle between the first support rod 241 in the first region A1 and the axis of the ablation unit 22 is greater than the angle between the first support rod 241 in the second region A2 and the axis of the ablation unit 22. When the ablation section 22 of this embodiment unfolds in the airway, both the first region A1 and the second region A2 are subjected to radially inward squeezing force generated by the inner wall of the airway. Under the action of this squeezing force, the first region A1 and the second region A2 move closer to each other, so that the first support rod 241 on both sides of the circumferential upward edge of the second region A2 abuts against the inner side of the wall-adhering unit 23 in the first region A1, thereby generating a radially outward resisting force on the wall-adhering unit 23 in the first region A1. This resisting force helps the wall-adhering unit 23 in the first region A1 to be formed into a relatively straight shape, so that it can better adhere to the rear wall membrane 12.

[0091] Due to the presence of the aforementioned resistance force, the number of first support rods 241 in the first region A1 can be appropriately reduced. For example, the first support rods 241 on both sides of the circumferential direction in the first region A1 can be omitted. The wall-attaching unit 23 in the first region A1 can also fit the wall membrane portion 12 better. Furthermore, the reduction in the number of first support rods 241 helps to reduce the size of the ablation portion 22 after radial compression, making it easier for the ablation portion 22 to be sheathed.

[0092] Example 3

[0093] This embodiment is largely the same as the ablation device 20 in Embodiment 1, and the similarities will not be repeated. The difference lies in the specific structure of the wall-adhering unit 23. (Refer to...) Figure 12 In this embodiment, the wall-adhering unit 23 includes a mesh structure 26. In this embodiment, all wall-adhering units 23 in the first region A1, which are used to adhere to the relatively flat posterior wall membrane 12 in the airway, have a mesh structure 26, and all wall-adhering units 23 in the second region A2, which are used to adhere to the C-shaped region of the airway, also have a mesh structure 26. In other embodiments, only the wall-adhering units 23 in the first region A1 include a mesh structure 26, and the structure of the wall-adhering units 23 in the second region A2 can be referred to the exemplary description of Embodiment 1; or, only the wall-adhering units 23 in the second region A2 include a mesh structure 26, and the structure of the wall-adhering units 23 in the first region A1 can be referred to the exemplary description of Embodiment 1.

[0094] In this embodiment, the mesh structure 26 is sheet-like and can be formed by cutting or weaving. For example, the mesh structure 26 includes multiple spaced-apart first-direction support wires and multiple spaced-apart second-direction support wires. The first-direction support wires extend generally along the first direction, and the second-direction support wires extend generally along the second direction. The first-direction support wires and the second-direction support wires overlap (or interweave) to form multiple quadrilateral mesh openings and multiple intersecting units. The intersecting units include the intersection points formed by the first-direction support wires and the second-direction support wires. The quadrilateral mesh openings are generally square, but can also be rhomboid, rectangular, or other shapes. Four intersecting units are provided at the four corners of the quadrilateral mesh openings. The edge contour of the mesh structure 26 is arc-shaped and bends and protrudes outward toward the ablation portion 22. The mesh structure 26 also has deformable properties and can undergo elastic deformation when subjected to external force. Adjacent mesh structures 26 have gaps at least at their distal ends, thereby blocking the transmission of force between the two mesh structures 26, so that mesh structure 26 can deform independently relative to its adjacent mesh structure 26 to adapt to the airway inner wall with a "D" shaped cross-section.

[0095] The aforementioned mesh structure 26 is connected to the support unit 24 at both ends in the circumferential direction. For example, one end of the mesh structure 26 in the circumferential direction is fixedly connected to the distal end of one of the first support rods 241 of the first support unit 24a by means of bonding, welding, or other methods, and the other end of the mesh structure 26 in the circumferential direction is fixedly connected to the distal end of one of the first support rods 241 of the second support unit 24b. Since the mesh structure 26 is connected to the support unit 24, when the ablation part 22 unfolds in the airway, the support unit 24 can drive the mesh structure 26 to expand radially and press against the inner wall of the airway. When the mesh structure 26 is squeezed by the inner wall of the airway, it deforms according to the shape of the inner wall of the airway to fit tightly against the inner wall of the airway.

[0096] In this embodiment, the aforementioned support wire is a conductive wire, which is exposed to form a mesh electrode. After being connected to and energized by the energy generator, the conductive wire forms a mesh electrode to output radio frequency (RF) energy to destroy nerves within the airway tissue. The conductive wire can be a nickel-titanium alloy wire, stainless steel wire, or any other conductive filament. The aforementioned support unit 24 can also be made of conductive metal and covered with an insulating layer. The support unit 24 is connected to both the mesh electrode and the energy generator. The electrical energy provided by the energy generator can be transmitted to the mesh electrode through the support unit 24 to form an ablation energy field, thus eliminating the need for additional wires on the mesh electrode.

[0097] Multiple circumferentially spaced mesh structures 26 can form a continuous annular ablation damage zone. Compared with the ablation method that generates multiple overlapping annular energy fields by multiple point electrodes 25, the energy of the mesh electrodes is more uniform and it is easier to control the output ablation energy, reducing the probability of the ablation device 20 causing burns to the airway.

[0098] Furthermore, the first and second support wires of the aforementioned mesh structure 26 can slide relative to each other at their intersections, or they can be fixed together. For the mesh structure 26 where the first and second support wires can slide relative to each other at their intersections, when compressed by the airway wall, the quadrilateral mesh openings in the mesh structure 26 are prone to deformation, causing the first and second support wires to accumulate in some areas and become sparse in others. In this case, if both the first and second support wires are conductive wires, the ablation energy generated in some areas of the mesh electrode will be stronger than that in others, resulting in incomplete ablation of nerves within the airway wall and damage to some parts of the airway wall due to excessive ablation energy. To prevent the above problems, the first and second support wires at at least some intersections in the mesh structure 26 are fixedly connected. For example, the first and second support wires at all intersections of the mesh structure 26 within the first region A1 are fixedly connected. This is achieved either by cutting to form the mesh structure 26 within the first region A1, or by welding, bonding, or winding to fix the intersections of the mesh structure 26. This prevents the support wires in the mesh structure 26 from slipping, ensuring uniform distribution even under pressure, thus forming a uniform ablation energy field and preventing damage to the posterior membrane 12 and the airway wall.

[0099] In other embodiments, the wall-mounted unit 23 may also include a plurality of waveform units spaced apart along the axial direction, the plurality of waveform units forming a mesh structure 26, each waveform unit including a plurality of circumferentially arranged waves connected end to end.

[0100] Example 4

[0101] Based on Examples 1-3, this embodiment reduces the possibility of irreversible damage to the target tissue (such as airway epithelial tissue) after heating during ablation. In this embodiment, the epithelial tissue of the target area can be cooled during ablation.

[0102] Reference Figure 13-15 The operating handle 230 in this embodiment (refer to...) Figure 3The device also has an interface for connecting a cooling device (not shown). The catheter 21, support member 22b, and ablation member 22a each have interconnected delivery channels 40, which are also connected to an external cooling device. The wall-adhering unit 23 and / or energy release unit have at least one first cooling hole 28, which connects the delivery channel 40 to the outside. The cooling device can deliver a cooling medium (e.g., physiological saline) into the delivery channel 40, which is then discharged through the first cooling hole 28 to the target tissue (e.g., directly contacting the airway epithelium) to remove some heat. The cooling medium discharged into the target tissue can be recovered using a bronchoscope after treatment.

[0103] Reference Figure 16 In other embodiments, an extension tube 211 can be fixedly connected to the distal end of the conduit 21. The extension tube 211 and the conduit 21 have interconnected delivery channels 40, and the surface of the extension tube 211 has at least one first cooling hole 28. This first cooling hole 28 connects the delivery channel 40 to the outside environment and is substantially flush with at least one energy release unit (approximately located in the same radial plane). The cooling device can deliver a cooling medium (e.g., physiological saline) to the delivery channel 40, which is then sprayed outward through the first cooling hole 28 to the target tissue (e.g., directly contacting the epithelial tissue of the airway) to remove some heat. During this process, pressure can be applied to the cooling medium to increase its spray range. Because of the addition of the extension tube 211, the delivery channels 40 inside the support member 22b and the ablation member 22a can be omitted.

[0104] Example 5

[0105] This embodiment proposes another cooling method based on embodiment 4.

[0106] Reference Figure 17 , Figure 18The ablation device 20 in this embodiment also includes a cooling balloon 30. The cooling balloon 30 includes a balloon body 31 with an inner cavity 311, an outer tube 32 connected to the balloon body 31, an inner rod 33, and a second cooling hole 34 on the surface of the cooling balloon 30. The balloon body 31 can expand and compress radially. When the balloon body 31 is in an expanded state, it includes a proximal segment 312, a distal segment 313, and an intermediate segment 314 connecting the proximal segment 312 and the distal segment 313 at both ends. The cross-sectional shape of the balloon body 31 is approximately circular. In other embodiments, the cross-section of the balloon body 31 can also be elliptical, crescent-shaped, semi-circular, or any other suitable shape. The proximal segment 312 and distal segment 313 are generally conical, and the intermediate segment 314 is generally cylindrical. In this embodiment, the cross-sectional area of ​​the proximal end of the proximal segment 312 is smaller than that of the distal end, the cross-sectional areas of the intermediate segment 314 are approximately equal, and the cross-sectional area of ​​the proximal end of the distal segment 313 is larger than that of the distal end. The balloon body 31 can be a compliant balloon, a non-compliant balloon, or a semi-compliant balloon, and can be made of one or more of the following materials: nylon, Pebax, polyurethane, polyethylene phthalate, and polyethylene.

[0107] An outer tube 32 is inserted into a catheter 21, with its proximal end connected to a cooling device via an operating handle 230. The distal end of the outer tube 32 is connected to the balloon body 31. An inner rod 33 is inserted into the lumen of the outer tube 32, with its outer diameter smaller than the inner diameter of the outer tube 32. The proximal end of the inner rod 33 is connected to the operating handle 230, and its distal end is located within the balloon body 31 and connected to the distal end of the balloon body 31. A gap is formed between the outer tube 32 and the inner rod 33, serving as a delivery channel 40. This delivery channel 40 communicates with the balloon cavity 311 of the balloon body 31, and is used to deliver the cooling medium from the cooling device to the balloon cavity 311. When the balloon cavity 311 is filled with the cooling medium, it is in an expanded state. When the cooling medium in the balloon cavity 311 is expelled, the balloon cavity 311 contracts, at which point the balloon body 31 is in a contracted state.

[0108] In this embodiment, the surface of the balloon body 31 is provided with a ring of second cooling holes 34, which includes a plurality of second cooling holes 34 arranged at intervals along the circumference. In other embodiments, the balloon surface may also be provided with multiple rings of second cooling holes 34, or a completely different arrangement of the second cooling holes 34 may be used.

[0109] During the ablation process, the cooling balloon 30, in a contracted state, is first inserted into the ablation section 22. The cooling device delivers cooling medium into the balloon cavity 311 of the balloon body 31 through the delivery channel 40, causing the balloon body 31 to expand. The outer surface of the expanded balloon body 31 is in close contact with the inner wall of the target tissue, and the cooling medium is discharged to the inner wall of the target tissue through the second cooling hole 34. It should be noted that because the electrode 25 outputs ablation energy to heat the surrounding tissue, the position of the second cooling hole 34 should be as close as possible to the electrode 25. For example, multiple second cooling holes 34 are located near the distal end face of the ablation section 22 to ensure that the cooling medium is discharged to the heated tissue as much as possible, thereby improving the cooling effect.

[0110] In this embodiment, the cooling balloon 30 is used to cool the target tissue, effectively reducing the possibility of irreversible damage caused by heating the target tissue. Furthermore, when inflated, the cooling balloon 30 also helps the ablation section 22 adhere better to the tissue wall.

[0111] Furthermore, the ablation section 22 used in conjunction with the cooling balloon 30 in this embodiment has a slightly different shape from the ablation section 22 in embodiments 1-4. The difference lies in that the support unit 24 of the ablation section 22 used in conjunction with the cooling balloon 30 in this embodiment is bent at its distal end to form a straight section. This straight section 240 is fixedly connected to the wall-adhering unit 23. The angle between the straight section 240 and the axis of the ablation section 22 is smaller than the angle between the remaining area of ​​the support unit 24 and the axis of the ablation section 22. The angle between the straight section 240 and the axis of the ablation section 22 ranges from 0 to 10°. Due to the presence of the straight section 240, not only is the wall-adhering effect of the ablation section 22 improved, but the adhesion area between the cooling balloon 30 and the target tissue is also increased.

[0112] Reference Figure 19 In other embodiments, the second cooling hole 34 can be omitted, and a retrieval channel 50 is formed in the inner rod 33. Its proximal end is connected to a retrieval device via an operating handle 230, allowing the retrieval channel 50 to communicate with the retrieval device. The inner rod 33 has a retrieval hole 35 connecting the retrieval channel 50 and the balloon cavity 311. By applying negative pressure to the retrieval channel 50, the cooling medium in the balloon cavity 311 is retrieved through the retrieval channel 50, thus forming a cooling circuit. The construction of this cooling circuit facilitates continuous cooling of the target tissue and prevents excessive cooling medium from entering the body.

[0113] Furthermore, the distance from the recovery port 35 to the distal end of the balloon body 31 is less than the distance from the recovery port 35 to the proximal end of the balloon body 31. This arrangement allows the cooling medium to be fully in contact with the ablation zone tissue before being recovered, maximizing the cooling of the target tissue.

[0114] In other embodiments, the inner rod 33 may be located outside the outer tube 32 and the balloon body 31, and may also form a cooling circuit together with the outer tube 32 and the balloon body 31. Furthermore, in other embodiments, the inner rod 33 may be omitted. The outer tube 32 may not only have a delivery channel 40 to deliver the cooling medium to the balloon body 31, but may also have a recovery channel 50 to output the cooling medium from the balloon body 31 to a recovery device. The input and recovery of the cooling medium during the ablation process can be repeated multiple times according to cooling requirements.

[0115] Example 6

[0116] Based on Example 5, this embodiment proposes another cooling balloon 30.

[0117] See Figure 20In this embodiment, the cooling balloon 30 includes a first balloon body 31a with an inner cavity, an outer tube 32 fixedly connected to the proximal end of the first balloon body 31a, a second balloon body 31b, an inner tube 33a fixedly connected to the proximal end of the second balloon body 31b, and an inner rod 33. The first balloon body 31a has a first balloon inner cavity 311a, and the second balloon body 31b has a second balloon inner cavity 311b; their specific structures are largely the same as in Embodiment 6. The first balloon body 31a is sleeved outside the second balloon body 31b, and the first balloon body 31a and the second balloon body 31b are coaxially arranged, forming a cooling cavity between the inner surface of the first balloon body 31a and the outer surface of the second balloon body 31b. The inner tube 33a passes through the cavity of the outer tube 32, and the outer diameter of the inner tube 33a is smaller than the inner diameter of the outer tube 32. The proximal end of the inner tube 33a is connected to a cooling device via an operating handle. The outer tube 32 passes through the conduit 21, and its proximal end is connected to a retrieval device via an operating handle 230. The lumen of the inner tube 33a forms a delivery channel 40, which communicates with the inner cavity 311b of the second balloon and is used to deliver the cooling medium from the cooling device to the inner cavity 311b of the second balloon. A retrieval channel 50 is formed between the outer surface of the inner tube 33a and the inner surface of the outer tube 32. This retrieval channel 50 communicates with the inner cavity 311a of the first balloon and is used to retrieve the cooling medium from the inner cavity 311a of the first balloon. The second balloon body 31b is provided with one or more output holes 37, which connect the inner cavity of the first balloon 311a and the inner cavity of the second balloon 311b. These output holes 37 are used to output the cooling medium from the second balloon body 31b to the inner cavity of the first balloon 311a after the second balloon body 31b is filled with cooling medium and inflated. After the first balloon body 31a is inflated, the cooling medium in the inner cavity of the first balloon 311a can be discharged to the recovery device through the recovery channel 50. An inner rod 33 passes through the inner tube 33a, with its proximal end connected to the operating handle 230, and its distal end passing through the inner cavity of the second balloon 311b and fixedly connected to the second balloon body 31b. The inner rod 33 not only reinforces the outer tube 32 but also provides support for the balloon body 31 when it is in a compressed state, maintaining the stability of the balloon body 31's shape and preventing it from shortening.

[0118] During the ablation process, a compressed cooling balloon 30 is first inserted into the ablation section 22. The cooling device delivers cooling medium to the inner cavity 311b of the second balloon through the delivery channel 40, causing the second balloon body 31b to expand. The cooling medium inside the second balloon body 31b flows into the first balloon body 31a through the output port 37, causing the outer surface of the first balloon body 31a to adhere tightly to the inner wall of the target tissue, thereby cooling the inner wall of the target tissue. By applying negative pressure to the recovery channel 50, the cooling medium in the first balloon body 31a is recovered through the recovery channel 50, thus forming a cooling circuit. The construction of the cooling circuit facilitates continuous cooling of the target tissue and avoids excessive cooling medium entering the body.

[0119] In this embodiment, by coaxially arranging the first balloon body 31a and the second balloon body 31b and forming a cooling cavity between the first balloon body 31a and the second balloon body 31b, the flow rate of the cooling medium in the cooling cavity can be increased, thereby improving the cooling efficiency of the outer surface of the balloon body 31.

[0120] Furthermore, the distance from the output port 37 to the distal end of the second balloon body 31b is less than the distance from the output port 37 to the proximal end of the second balloon body 31b. This arrangement allows the cooling medium to fully contact the ablation zone tissue before being recovered, maximizing the cooling of the target tissue.

[0121] Example 7

[0122] Based on Examples 5 and 6, this embodiment proposes another cooling balloon 30.

[0123] See Figure 21In this embodiment, the cooling balloon 30 includes an inflatable balloon body 31 and an outer tube 32 and an inner rod 33 fixedly connected to the balloon body 31. The balloon body 31 includes a balloon wall 315 and a balloon cavity 311 formed by the balloon wall 315. The balloon cavity 311 includes a first balloon cavity 311a, a second balloon cavity 311b, and a separator 38 arranged radially. The separator 38 is fixedly connected to the inside of the balloon body 31 and is disposed between the first balloon cavity 311a and the second balloon cavity 311b, for dividing the balloon cavity 311 into the first balloon cavity 311a and the second balloon cavity 311b. The first balloon cavity 311a has a first outer wall 315a, and the second balloon cavity 311b has a second outer wall 315b. The first outer wall 315a and the second outer wall 315b are arranged circumferentially in the balloon body 31 for adhering to the target tissue when the balloon body 31 is inflated. The distal end of the outer tube 32 is connected to the proximal end of the balloon body 31. The outer tube 32 is a multi-lumen tube with independent receiving cavities, delivery channels 40 and retrieval channels 50 inside. The receiving cavity is used to receive the inner rod 33, which passes through the receiving cavity. The outer diameter of the inner rod 33 is less than or equal to the inner diameter of the receiving cavity. The proximal end of the inner rod 33 is connected to the operating handle 230. The distal end of the inner rod 33 is located inside the balloon body 31 and is connected to the distal end of the balloon body 31. The inner rod 33 not only strengthens the outer tube 32, but also provides support for the balloon body 31 when it is in a compressed state, maintaining the stability of the balloon body 31's shape and preventing the balloon body 31 from shortening or curling. The proximal end of the delivery channel 40 is connected to an external cooling device, and the distal end is connected to the inner cavity 311b of the second balloon. It is used to deliver the cooling medium in the cooling device to the inner cavity 311b of the second balloon. The proximal end of the recovery channel 50 is connected to an external recovery device, and the distal end is connected to the inner cavity 311a of the first balloon. It is used to output the cooling medium in the inner cavity 311a of the first balloon to the recovery device after the inner cavity 311a of the first balloon is filled with cooling medium and expands.

[0124] At least one output port 37 is provided between the first balloon cavity 311a and the second balloon cavity 311b. This output port 37 connects the first balloon cavity 311a and the second balloon cavity 311b, allowing cooling medium to flow between them. (Refer to...) Figure 21 The separator 38 includes a thin sheet-like structure 38a, whose proximal and distal edges are fixedly connected to the inner rod 33, and whose two side edges are respectively sealed to the balloon wall 315. The output port 37 can be located on the inner rod 33 between the distal edge of the separator 38 and the distal end of the balloon body 31. (Refer to...) Figure 22In other embodiments, the output hole 37 is provided on the separator 38. In other embodiments, a gap may be left between the distal edge of the separator 38 and the distal end of the balloon body 31, the gap connecting the first balloon cavity 311a and the second balloon cavity 311b, and the gap may serve as the output hole 37.

[0125] During the ablation process, a compressed cooling balloon 30 is first inserted into the ablation section 22. A cooling device delivers cooling medium to the inner cavity 311b of the second balloon through a delivery channel 40, causing the inner cavity 311b to expand and its second outer wall 315b to adhere to the target tissue. The cooling medium in the inner cavity 311b flows into the inner cavity 311a of the first balloon through an outlet port 37, causing the inner cavity 311a to expand and its first outer wall 315a to adhere to the target tissue, thus cooling the inner wall of the target tissue. By applying negative pressure to the recovery channel 50, the cooling medium in the inner cavity 311a of the first balloon is recovered through the recovery channel 50 to an external recovery device, thus forming a cooling circuit. The construction of this cooling circuit facilitates continuous cooling of the target tissue and prevents excessive cooling medium from entering the body.

[0126] Furthermore, the distance from the output port 37 to the distal end of the balloon body 31 is less than the distance from the output port 37 to the proximal end of the balloon body 31. This arrangement allows the cooling medium to fully contact the tissue in the ablation zone before being recovered, maximizing the cooling of the target tissue.

[0127] During ablation, the relatively flat posterior wall membrane 12 of the airway is more prone to scarring than the "C"-shaped area within the airway. To better protect the epithelial tissue of the posterior wall membrane 12, it is necessary to improve the cooling efficiency of the cooling balloon 30 at the posterior wall membrane 12. The cooling efficiency (the rate at which heat is removed from the target tissue) of the cooling balloon 30 is closely related to the flow rate of the cooling medium. The faster the flow rate of the cooling medium, the faster it removes heat; conversely, the slower the flow rate of the cooling medium, the slower it removes heat.

[0128] In this embodiment, the second outer wall 315b is used to fit against the rear wall membrane 12, while the first outer wall 315a is used to fit against the "C"-shaped region of the airway. The first cross-sectional area of ​​the first balloon cavity 311a within the axial region where the first outer wall 315a is located is denoted as the first cross-sectional area, and the second cross-sectional area of ​​the second balloon cavity 311b within the axial region where the second outer wall 315b is located is denoted as the second cross-sectional area, wherein the first cross-sectional area is larger than the second cross-sectional area. When both the first balloon cavity 311a and the second balloon cavity 311b are in an inflated state, and the delivery speed of the cooling medium in the delivery channel 40 (i.e., the input speed of the cooling medium in the balloon body 31) is the same as the recovery speed of the cooling medium in the recovery channel 50 (i.e., the output speed of the cooling medium in the balloon body 31), the connected first balloon cavity 311a and the second inflatable cavity form a fluid channel. The flow rate of the cooling medium in each cross-section of this fluid channel is consistent, and the smaller second cross-sectional area makes the second outer wall 315b in the second balloon cavity 311b... The flow area of ​​the cooling medium in the axial region is smaller than the flow area of ​​the cooling medium in the axial region where the first outer wall 315a is located in the inner cavity 311a of the first balloon. Since the flow rate of a certain cross-section is the product of the flow velocity of that cross-section and the flow area (i.e., the cross-sectional area), the flow velocity of the cooling medium in the axial region where the second outer wall 315b is located is greater than the flow velocity of the cooling medium in the axial region where the first outer wall 315a is located. As a result, the cooling efficiency of the cooling balloon 30 at the second outer wall 315b is higher than the cooling efficiency of the cooling balloon 30 at the first outer wall 315a.

[0129] For example, refer to Figure 21 The axial regions where the first outer wall 315a and the second outer wall 315b of the cooling bladder 30 are located overlap, and the separator 38 includes a single sheet-like structure 38a. Figure 21 A schematic cross-sectional view of the balloon body 31 within the axial region containing the first outer wall 315a and the second outer wall 315b is shown. The cross-sectional shape of the balloon body 31 is generally circular, and the cross-sectional shape of the separator 38 is a straight line. The separator 38 divides the cross-section of the balloon body 31 into two crescent-shaped cross-sections, namely the first cross-section and the second cross-section. The first cross-section is the cross-section of the first balloon cavity 311a, and the second cross-section is the cross-section of the second balloon cavity 311b. The ratio between the area of ​​the first cross-section and the area of ​​the second cross-section is R1, where R1∈(1,6). In other embodiments, the cross-sectional area occupied by the first balloon cavity 311a in any cross-section of the balloon body 31 within the axial region containing the separator 38 can be made larger than the cross-sectional area occupied by the second balloon cavity 311b.

[0130] Reference Figure 22In another embodiment, the axial regions of the first outer wall 315a and the second outer wall 315b of the cooling balloon 30 overlap, and the separator 38 includes two sheet-like structures 38a, one edge of each sheet-like structure 38a is sealed to the inner rod 33, and the opposite edge is sealed to the balloon wall 315, so as to divide the balloon cavity 311 into the first balloon cavity 311a and the second balloon cavity 311b. Figure 22 The diagram shows a cross-sectional view of the balloon body 31 within the axial region containing the first outer wall 315a and the second outer wall 315b. The cross-sectional shape of the balloon body 31 is generally circular, while the cross-sectional shape of the separator 38 is a broken line (inverted "V" shape). The separator 38 divides the cross-section of the balloon body 31 into two sector-shaped cross-sections, namely the first cross-section and the second cross-section. The ratio of the central angle of the first cross-section to the central angle of the second cross-section is R2, where R2∈(1,3). The first cross-section is the cross-section of the first balloon cavity 311a, and the second cross-section is the cross-section of the second balloon cavity 311b, with the area of ​​the first cross-section being larger than the area of ​​the second cross-section.

[0131] Furthermore, the flow rate of the cooling medium in the first balloon cavity 311a and the second balloon cavity 311b can be controlled by adjusting the surface roughness of the inner surfaces of the first outer wall 315a and the second outer wall 315b. For example, the surface roughness of the inner surface of the second outer wall 315b can be made smaller than the surface roughness of the inner surface of the first outer wall 315a, so that the flow rate of the cooling medium flowing through the inner surface of the second outer wall 315b is greater than the flow rate of the cooling medium flowing through the inner surface of the first outer wall 315a. In other embodiments, the inner surface roughness of the first cavity wall surrounding the first balloon cavity 311a can also be made greater than the inner surface roughness of the second outer wall 315b surrounding the second balloon cavity 311b.

[0132] Furthermore, the first outer wall 315a and the second outer wall 315b can be made of different materials, so that the outer surface hardness of the second outer wall 325b is less than that of the first outer wall 315a, thereby enabling the second outer wall 325b to fit more tightly with the rear wall membrane portion 12.

[0133] Example 8

[0134] Based on Examples 5-7, this embodiment proposes another cooling balloon 30.

[0135] See Figure 23In this embodiment, the cooling balloon 30 includes an inflatable balloon body 31 and an outer tube 32 and an inner tube 33a fixedly connected to the balloon body 31. The balloon body 31 includes a balloon wall 315 and a balloon cavity 311 formed by the balloon wall 315. The balloon cavity 311 includes a first balloon cavity 311a, a second balloon cavity 311b, and a partition 38 arranged radially. The partition 38 is fixedly connected to the inside of the balloon body 31 and is disposed between the first balloon cavity 311a and the second balloon cavity 311b, for dividing the balloon cavity 311 into the first balloon cavity 311a and the second balloon cavity 311b. The first balloon cavity 311a has a first outer wall 315a, and the second balloon cavity 311b has a second outer wall 315b. The first outer wall 315a and the second outer wall 315b are arranged circumferentially in the balloon body 31 for conforming to the target tissue when the balloon body 31 is inflated. The distal end of the outer tube 32 is connected to the proximal end of the balloon body 31. The proximal end of the outer tube 32 is connected to a cooling device via an operating handle 230. The inner tube 33a passes through the lumen of the outer tube 32, and the outer diameter of the inner tube 33a is smaller than the inner diameter of the outer tube 32. The proximal end of the inner tube 33a is connected to a retrieval device via an operating handle 230. The distal end of the inner tube 33a is located inside the balloon body 31 and is connected to the distal end of the balloon body 31. The outer tube 32 is a multi-lumen tube with independent receiving cavities, a first delivery channel 40a, and a second delivery channel 40b. The receiving cavities house the inner tube 33a. The proximal ends of both the first and second delivery channels 40a and 40b are connected to an external cooling device. The distal end of the first delivery channel 40a is connected to the inner cavity 311a of the first balloon, used to deliver the cooling medium from the cooling device to the inner cavity 311a. The distal end of the second delivery channel 40b is connected to the inner cavity 311b of the second balloon, used to deliver the cooling medium from the cooling device to the inner cavity 311b. The inner tube 33a is also a multi-lumen tube with independent first and second recovery channels 50a and 50b. The proximal ends of both the first and second recovery channels 50a and 50b are connected to an external recovery device. At least one first output hole 37a is provided between the first recovery channel 50a and the first balloon cavity 311a. For example, the first output hole 37a is provided on the side wall of the inner tube 33a. The first output hole 37a connects the first recovery channel 50a and the first balloon cavity 311a, allowing cooling medium to flow between the first recovery channel 50a and the first balloon cavity 311a. At least one second output hole 37b is provided between the second recovery channel 50b and the second balloon cavity 311b. For example, the second output hole 37b is provided on the side wall of the inner tube 33a. The second output hole 37b connects the second recovery channel 50b and the second balloon cavity 311b, allowing cooling medium to flow between the second recovery channel 50b and the second balloon cavity 311b.The diameters of the first output port 37a and the second output port 37b must not be too small. For example, the diameter of the first output port 37a must be greater than or equal to the distal diameter of the first input channel 40a, and the diameter of the second output port 37b must be greater than or equal to the distal diameter of the second input channel 40b, to ensure that the cooling medium can flow smoothly within them. The first recovery channel 50a and the second recovery channel 50b are used to output the cooling medium in the first balloon cavity 311a and the second balloon cavity 311b to the recovery device after the first balloon cavity 311a and the second balloon cavity 311b are filled with cooling medium and expanded.

[0136] During the ablation process, a cooling balloon 30 in a contracted state is first inserted into the ablation section 22. The cooling device delivers cooling medium into the inner cavities 311a and 311b of the first and second balloons respectively through the first delivery channel 40a and the second delivery channel 40b, causing the inner cavities 311a and 311b to expand and adhere to the target tissue. The cooling medium in the inner cavity 311a flows into the first recovery channel 50a through the first output port 37a, and the cooling medium in the inner cavity 311b flows into the second recovery channel 50b through the second output port 37b. By applying negative pressure to the first recovery channel 50a and the second recovery channel 50b, the cooling medium in the inner cavities 311a and 311b of the first balloon is recovered to an external recovery device through the first recovery channel 50a and the second recovery channel 50b, thus forming a cooling circuit. The construction of the cooling circuit facilitates continuous cooling of the target tissue and avoids excessive cooling medium entering the human body. Furthermore, in this embodiment, both the inner cavities 311a and 311b of the first balloon are equipped with independent cooling circuits, allowing for individual adjustment of the cooling performance of each circuit.

[0137] Furthermore, the distance from the first output port 37a to the distal end of the balloon body 31 is less than the distance from the second output port 37b to the proximal end of the balloon body 31, and the distance from the second output port 37b to the distal end of the balloon body 31 is less than the distance from the second output port 37b to the proximal end of the balloon body 31. This arrangement allows the cooling medium to fully contact the tissue in the ablation zone before being recovered, maximizing the cooling of the target tissue.

[0138] During ablation, the relatively flat posterior wall membrane 12 of the airway is more prone to scarring than the "C"-shaped area within the airway. To better protect the epithelial tissue of the posterior wall membrane 12, it is necessary to improve the cooling efficiency of the cooling balloon 30 at the posterior wall membrane 12. The cooling efficiency of the cooling balloon 30 is closely related to the flow rate of the cooling medium. The faster the flow rate of the cooling medium, the faster it carries away heat; conversely, the slower the flow rate of the cooling medium, the slower it carries away heat. In this embodiment, when both the first balloon cavity 311a and the second balloon cavity 311b are inflated, the delivery speed of the cooling medium in the first delivery channel 40a (i.e., the input speed of the cooling medium in the first balloon cavity 311a) is the same as the recovery speed of the cooling medium in the first recovery channel 50a (i.e., the output speed of the cooling medium in the first balloon cavity 311a); the delivery speed of the cooling medium in the second delivery channel 40b (i.e., the input speed of the cooling medium in the second balloon cavity 311b) is the same as the recovery speed of the cooling medium in the second recovery channel 50b (i.e., the output speed of the cooling medium in the second balloon cavity 311b). Furthermore, the flow rate of the cooling medium in the second delivery channel 40b is greater than the flow rate of the cooling medium in the first delivery channel 40a, and the flow rate of the cooling medium in the second recovery channel 50b is greater than the flow rate of the cooling medium in the first recovery channel 50a.

[0139] When the cross-sectional area of ​​the second balloon cavity 311b in the axial region where the second outer wall 315b is located is equal to the cross-sectional area of ​​the first balloon cavity 311a in the axial region where the first outer wall 315a is located, the flow rate of the cooling medium in the second balloon cavity 311b in the axial region where the second outer wall 315b is located is greater than the flow rate of the cooling medium in the first balloon cavity 311a in the axial region where the first outer wall 315a is located, thereby making the cooling efficiency of the cooling balloon 30 at the second outer wall 315b higher than the cooling efficiency of the cooling balloon 30 at the first outer wall 315a.

[0140] Furthermore, the balloon body 31 of this embodiment can also refer to embodiment 8 to make the first cross-sectional area of ​​the first balloon cavity 311a in the axial region where the first outer wall 315a is located larger than the second cross-sectional area of ​​the second balloon cavity 311b in the axial region where the second outer wall 315b is located.

[0141] For example, refer to Figure 24In the figure, the axial regions of the first outer wall 315a and the second outer wall 315b of the cooling balloon 30 overlap, and the separator 38 includes a radially expandable and compressible inner balloon 31c and two sheet-like structures 38a. The inner balloon 31c is fixedly connected to the inner tube 33a, and a cooling cavity is formed between the outer surface of the inner balloon 31c and the inner surface of the balloon body 31. The sheet-like structures 38a are located in the cooling cavity and separate the first balloon inner cavity 311a and the second balloon inner cavity 311b from the cooling cavity. For example, a sheet-like structure 38a is provided on each side of the inner balloon 31c. One edge of each sheet-like structure 38a is sealed to the outer surface of the inner balloon 31c, and the other edge is sealed to the balloon wall 315 of the balloon body 31. The separator 38 divides the balloon inner cavity 311 into the first balloon inner cavity 311a and the second balloon inner cavity 311b. The inner balloon 31c of the third balloon cavity 311c and the inner balloon cavity 311b of the second balloon can be connected to the same second delivery channel 40b, or an independent third delivery channel 40 can be provided for the inner balloon 31c in the outer tube 32. Figure 24 A schematic cross-sectional view of the balloon body 31 within the axial region containing the first outer wall 315a and the second outer wall 315b is shown. The cross-section of the balloon body 31 has a circular outline, while the cross-section of the inner balloon 31c has a fan-shaped outline, the radius of which is smaller than the radius of the circular outline of the balloon body 31. The cross-section of the sheet-like structure 38a has a straight outline, and the fan-shaped outline has an arc-shaped edge 315c. The endpoints of the arc-shaped edge 315c are connected to the straight outline of the sheet-like structure 38a. The fan-shaped outline and the two straight outlines divide the cross-section of the balloon body 31 into three cross-sections: a first cross-section, a second cross-section, and a third cross-section. The first cross-section is the cross-section of the first balloon cavity 311a, the second cross-section is the cross-section of the second balloon cavity 311b, and the third cross-section is the cross-section of the inner balloon 31c. The area of ​​the first cross-section is larger than the area of ​​the second cross-section. The inner balloon 31c is designed to further compress the cross-section of the inner cavity 311b of the second balloon, thereby further increasing the flow rate of the cooling medium in the inner cavity 311b of the second balloon, and at the same time saving the cooling medium to a certain extent.

[0142] Example 9

[0143] Based on Examples 5-8, this embodiment proposes another cooling balloon 30.

[0144] See Figure 25 , Figure 26In this embodiment, the cooling balloon 30 includes an inflatable balloon body 31, a cooling conduit 70, an outer tube 32 fixedly connected to the balloon body 31, and an inner rod 33. The balloon body 31 includes a balloon wall 315 and a balloon cavity 311 formed by the balloon wall 315. The balloon cavity 311 is radially compressible and radially inflatable. The balloon wall 315 includes a first outer wall 315a and a second outer wall 315b, which are arranged circumferentially around the balloon body 31 for adhering to the target tissue when the balloon body 31 is inflated. The distal end of the outer tube 32 is connected to the proximal end of the balloon body 31. The proximal end of the outer tube 32 is connected to a retrieval device via an operating handle 230. The inner rod 33 passes through the lumen of the outer tube 32. The proximal end of the inner rod 33 is connected to the operating handle 230, and the distal end of the inner rod 33 is located inside the balloon body 31 and connected to the distal end of the balloon body 31. The outer tube 32 is a multi-lumen tube with three independent receiving cavities: a first receiving cavity 60a, a second receiving cavity 60b, and a third receiving cavity 60c. The first receiving cavity 60a is used to receive the inner rod 33, which passes through the receiving cavity. The outer diameter of the inner rod 33 is smaller than the diameter of the first receiving cavity 60a, and a delivery channel 40 can be formed between the inner rod 33 and the first receiving cavity 60a. The delivery channel 40 is connected proximally to an external delivery device and distally to the balloon cavity 311, for delivering the inflation medium from the delivery device to the balloon cavity 311 to inflate the balloon cavity 311. The delivery device can be a cooling device, and the inflation medium can be a cooling medium. In other embodiments, the delivery device can deliver any other suitable inflation medium. The cooling conduit 70 has an input end, a retrieval end (not shown), and a main body between the input and retrieval ends. The input end passes through the second receiving cavity 60b and is externally connected to the cooling device via an operating handle 230, for delivering the cooling medium from the cooling device to the cooling conduit 70. The retrieval end passes through the third receiving cavity 60c and is externally connected to the retrieval device via the operating handle 230, for outputting the cooling medium from the cooling conduit 70 to the retrieval device.

[0145] To enable the cooling conduit 70 to exhibit radial expansion and contraction properties, it can be made of the same or different material as the balloon body 31. For example, it can be made of one or a mixture of materials such as nylon, Pebax, polyurethane, polyethylene phthalate, and polyethylene. In this embodiment, the main body of the cooling conduit 70 includes a surrounding section 71 that surrounds the outer surface of the balloon body 31. For example, the surrounding section 71 is fixedly connected to the outer surface of the balloon body 31 (e.g., it is integrally formed with the balloon body 31) and is used to conform to the target tissue for cooling. In other embodiments, the surrounding section 71 can be disposed inside the balloon body 31 and closely adhere to the inner surface of the balloon body 31.

[0146] The surrounding segment 71 includes multiple main segments 711 arranged circumferentially along the balloon body 31 (e.g., multiple main segments 711 arranged in parallel), with the multiple main segments 711 connected end-to-end in the circumferential direction. Each main segment 711 is straight and has a head end and a tail end, with the head end closer to the outer tube 32 than the tail end. In other embodiments, the main segments 711 may also have other shapes such as wavy or arc-shaped. Furthermore, in this embodiment, the cross-sectional shape of the main segment 711 is circular. In other embodiments, the cross-sectional shape of the main segment 711 may also be elliptical, quadrilateral, etc. When the cross-sectional shape of the main segment 711 is quadrilateral, it is beneficial to increase its contact area with the target tissue, thereby improving cooling efficiency.

[0147] During ablation, a compressed cooling balloon 30 is first inserted into the ablation section 22. A delivery device then inflates the balloon body 31 by supplying filling medium through a delivery channel 40. Simultaneously, a cooling device continuously supplies cooling medium to the input end of the cooling pipe 70, causing it to expand and its surrounding section 71 to adhere to the target tissue. By applying negative pressure to the recovery channel 50, the cooling medium in the cooling pipe 70 is recovered through its output end to an external recovery device, thus forming a cooling circuit. This cooling circuit facilitates continuous cooling of the target tissue and prevents excessive cooling medium from entering the body.

[0148] During ablation, the relatively flat posterior wall membrane 12 in the airway is more prone to scarring than the "C"-shaped area in the airway. To better protect the epithelial tissue of the posterior wall membrane 12, it is necessary to improve the cooling efficiency of the cooling balloon 30 at the posterior wall membrane 12. In this embodiment, the second outer wall 315b is used to adhere to the posterior wall membrane 12, while the first outer wall 315a is used to adhere to the "C"-shaped area of ​​the airway. The density of the cooling channels 70 on the first outer wall 315a is less than that on the second outer wall 315b, resulting in a higher cooling efficiency of the cooling balloon 30 at the second outer wall 315b than at the first outer wall 315a. The above-mentioned density test method includes the following steps: cut off the balloon wall 315 (first outer wall 315a or second outer wall 315b) to be tested and the cooling pipes 70 covering it, unfold the balloon wall 315 to be tested and lay it flat on a plane, measure the area S1 enclosed by the outer contour of the balloon wall 315 to be tested in the unfolded state, and further measure the sum of the orthographic projection areas S2 of the outermost cooling pipes 70 on the balloon wall 315 to be tested in the plane. The ratio of the sum of the orthographic projection areas of the outermost cooling pipes 70 on the balloon wall 315 to the area enclosed by the outer contour of the balloon wall 315 to be tested (i.e., (S2 / S1)) is the density.

[0149] For example Figure 26The cooling pipes 70 are arranged in a manner where the main body segments 711 on the balloon body 31 are arranged in parallel and evenly spaced intervals, and the diameters of the main body segments 711 are approximately equal. The density of the cooling pipes 70 on the first outer wall 315a and the second outer wall 315b can be compared by measuring the gaps between adjacent main body segments 711 on the first outer wall 315a and the second outer wall 315b. For example, the larger the gap width between adjacent main body segments 711, the smaller the density of the cooling pipes 70; conversely, the smaller the gap width between adjacent main body segments 711, the greater the density of the cooling pipes 70. Figure 26 As can be seen, in this embodiment, the gap width between adjacent main body segments 711 on the first outer wall 315a is greater than the gap width between adjacent main body segments 711 on the second outer wall 315b.

[0150] It is understood that the cooling balloon 30 in the above embodiments 5-9 is not limited to use in conjunction with the ablation part 22 in embodiments 1-4. In other embodiments, the cooling balloon 30 can also be used in conjunction with ablation parts 22 of other shapes and structures. For example, one or more electrodes 25 can be fixedly provided on the outer surface of the cooling balloon 30. The electrodes 25 are ablation parts 22. The electrodes 25 are connected to an external energy generator, which can also achieve the effect of ablation of target tissue.

[0151] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention 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 the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. An ablation device, characterized in that, include: The catheter and the ablation unit connected to the distal end of the catheter, the ablation unit having expandable properties and including multiple ablation components, each of the ablation components including a support unit, a wall-adhering unit and an energy release unit disposed on the wall-adhering unit; Multiple support units are radially extended outward and extend toward the distal end of the ablation section to connect with multiple wall-adhering units; when the ablation section is in a naturally expanded state, at least one wall-adhering unit in the ablation section can deform independently relative to its adjacent wall-adhering unit; The ablation device has a first region and a second region. The wall-adhering units in the first region can deform independently relative to their adjacent wall-adhering units. The wall-adhering units in the first region and the second region are located on different planes. The wall-adhering units in the first region are located between the wall-adhering units in the second region and the catheter. When both the first region and the second region are subjected to a force in the direction toward the inside of the ablation part, at least one wall-adhering unit in the second region abuts against the inside of the wall-adhering unit in the first region.

2. The ablation device according to claim 1, characterized in that, Multiple support units are arranged together to form a cavity with an opening at the distal end, and multiple wall-attaching units are arranged at intervals around the opening.

3. The ablation device according to claim 1, characterized in that, The wall-attached unit includes a first connecting end and a second connecting end connected to the support unit, and a deformable segment extending between the first connecting end and the second connecting end. The deformable segment has elastic deformation properties. When the ablation part is in a naturally expanded state, the deformable segment bends and protrudes relative to the first connecting end and the second connecting end toward the outside of the ablation part.

4. The ablation device according to claim 3, characterized in that, When the deformable segment is subjected to a force toward the inside of the ablation portion, the deformable segment can undergo elastic deformation, thereby increasing the distance between the first connecting end and the second connecting end.

5. The ablation device according to claim 3, characterized in that, The deformable segment includes a first wall-attached segment and a second wall-attached segment. One end of the first wall-attached segment is connected to the first connecting end, and the other end of the first wall-attached segment is connected to one end of the second wall-attached segment. The other end of the second wall-attached segment is connected to the second connecting end. The first connecting end and the second connecting end can approach each other under the action of external force and move away from each other when the external force is removed.

6. The ablation device according to claim 5, characterized in that, Both the first and second wall-attaching segments include an arc-shaped structure protruding outwards from the ablation region; or, both the first and second wall-attaching segments include a straight structure inclined outwards from the ablation region; or, one of the first and second wall-attaching segments includes an arc-shaped structure protruding outwards from the ablation region, and the other includes a straight structure inclined outwards from the ablation region.

7. The ablation device according to claim 5, characterized in that, The deformable segment further includes a connecting segment, which includes a distal vertex and a first connecting arm and a second connecting arm that jointly connect the distal vertex. There is a gap between the proximal ends of the first connecting arm and the proximal ends of the second connecting arm. One end of the first wall-attached segment is connected to the first connecting end, and the other end of the first wall-attached segment is connected to the first connecting arm. One end of the second wall-attached segment is connected to the second connecting arm, and the other end of the second wall-attached segment is connected to the second connecting end.

8. The ablation device according to claim 7, characterized in that, The connecting segment protrudes toward the distal end of the ablation device.

9. The ablation device according to claim 3, characterized in that, The support unit includes two spaced-apart first support rods, with the first connecting end and the second connecting end respectively fixedly connected to one of the first support rods.

10. The ablation device according to claim 9, characterized in that, The ablation unit further includes a support member, which comprises multiple spaced second support rods. The proximal end of each second support rod is fixedly connected to the catheter, and the distal end of each second support rod is fixedly connected to two adjacent first support rods.

11. The ablation device according to claim 1, characterized in that, The support unit includes a straight section and is connected to the wall-attached unit through the straight section. In the natural expansion state, the angle between the straight section and the axis of the ablation part is smaller than the angle between the other areas of the support unit (excluding the straight section) and the axis of the ablation part.

12. The ablation device according to claim 1, characterized in that, The energy release unit located in the first region includes an electrode pair and / or a strip electrode, wherein the electrode pair includes a first electrode and a second electrode with opposite polarities, and the first electrode and the second electrode are disposed at intervals on one or more of the wall-mounted units; the strip electrode extends along the length direction of the wall-mounted unit.

13. The ablation device according to claim 1, characterized in that, The wall-attached unit includes a sheet-like mesh structure, which includes conductive wires, and the exposed conductive wires form mesh electrodes.

14. The ablation device according to claim 1, characterized in that, The catheter and the ablation section have interconnected delivery channels; and / or, the distal end of the catheter is provided with an extension tube, the extension tube is inserted into the ablation section, and the catheter and the extension tube have interconnected delivery channels; the surface of the ablation section and / or the extension tube is provided with a first cooling hole, the first cooling hole connects the delivery channel to the outside, the delivery channel is used to deliver cooling medium, and the first cooling hole is used to release cooling medium to the outside.

15. The ablation device according to claim 1, characterized in that, The ablation device further includes a cooling balloon, which comprises a balloon body having an inner cavity and a delivery channel communicating with the inner cavity. The balloon body is disposed in the inner cavity of the ablation part, and when the balloon body is in an inflated state, the outer surface of the balloon body is in contact with the wall-adhering unit. The delivery channel is used to deliver a cooling medium to the inner cavity of the balloon. The surface of the cooling balloon is provided with one or more second cooling holes, which are used to communicate the inner cavity of the balloon with the outside and to discharge the cooling medium in the inner cavity of the balloon to the outside.

16. The ablation device according to claim 15, characterized in that, The cooling balloon also includes a recovery channel communicating with the inner cavity of the balloon, the recovery channel being used to recover the cooling medium in the inner cavity of the balloon.

Images