Ablation device

Abstract

The ablation device comprises a pushing part and an ablation component connected to the far end of the pushing part, and the ablation component has the first state that the ablation component is self-unfolded to be in a funnel shape when not restrained and the second state that the ablation component is deformed and gathered when restrained in the radial direction; the ablation component comprises a supporting framework, the supporting framework comprises a plurality of deformation units located on the far end side, the multiple deformation units are arranged in a circumferential enclosing mode, and the multiple enclosed deformation units are adjacent to one another and can independently deform relative to the adjacent deformation units; the pushing part comprises a plurality of connecting arms arranged at the far end, the multiple connecting arms are arranged at intervals in the circumferential direction, and the free ends of the multiple connecting arms are connected with the near ends of the multiple deformation units correspondingly. The ablation device at least solves the problem that an ablation component is not prone to entering a sheath.

Description

Technical Field

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

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Chronic obstructive pulmonary disease (COPD) is the most common type of chronic airway disease currently. It can seriously affect the patient's quality of life and is an important cause of death.

[0004] Targeted Lung Denervation (TLD) is a new trend in the treatment of COPD in recent years. TLD ablation mainly releases ablation energy through an ablation device to ablate the parasympathetic nerves on the outer wall of the bronchus, thereby blocking the transmission of nerve signals, relaxing airway smooth muscles, and reducing mucus secretion, thereby improving symptoms of airway obstruction and dyspnea.

[0005] The structure of the existing ablation device is as follows Figure 1 As shown, the electrode support unit 10' of the ablation device 100' needs to be retracted in the sheath tube, and the electrode support unit 10' of the ablation device is released when reaching the target position. The electrode support unit 10' of the ablation device 100' needs to completely restore its deformation after being unsheathed, so that the ablation electrode is completely in contact with the ablation tissue site. When the umbrella-shaped electrode support unit 10' is subjected to a pulling force such as F', the umbrella-shaped electrode support unit 10' will move axially with the pulling force and be received into the outer sheath tube 400'. When the sheath is retracted, there are the following problems: 1. The front end bends of adjacent support units 10' (such as Figure 1 2. When the umbrella-shaped electrode support unit 10' initially enters the sheath tube, the proximal end of the support unit (i.e. Figure 1 At point B' in the figure, a hard abutment and extrusion will be formed with the outer sheath 400'. At this time, it is not only difficult to enter the sheath but also easy to cause damage here. At the same time, the circumferential movement of the support unit 10' at the abutment point is also restricted, which is not conducive to the formation of the staggered shape of the umbrella-like structure. This also invisibly aggravates the problem of the top of the far end of the support unit. Summary of the invention

[0006] Based on this, the present invention proposes an ablation device to solve at least one of the above problems.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] The present invention provides an ablation device, comprising a pushing part and an ablation member connected to the distal end of the pushing part. The ablation member has a first state in which it self-unfolds into a funnel shape when unconstrained, and a second state in which it deforms and converges when radially constrained; the ablation member includes a support skeleton, and the support skeleton includes a plurality of deformation units located on the distal side. The plurality of deformation units are circumferentially enclosed and arranged, and the enclosed plurality of deformation units are adjacent to each other and can each independently deform relative to the adjacent deformation unit; the pushing part includes a plurality of connecting arms provided at the distal end, the plurality of connecting arms are circumferentially spaced apart, and the free ends of the plurality of connecting arms are respectively connected to the proximal ends of the plurality of deformation units.

[0009] In one embodiment, each of the deformation units includes a first deformation part and a second deformation part connected in the circumferential direction. One of the first deformation parts of each of the deformation units is adjacent to one of the second deformation parts of the adjacent deformation unit;

[0010] The support skeleton further includes a plurality of main support rods, the plurality of main support rods are circumferentially spaced apart, the proximal end of each main support rod is connected to the free end of a connecting arm, and the distal end of each main support rod is simultaneously connected to the proximal ends of two adjacent first deformation parts and two adjacent second deformation parts in two adjacent deformation units.

[0011] In one embodiment, there is a gap between the proximal sides of two adjacent first deformation parts and two adjacent second deformation parts in two adjacent deformation units, and the circumferential pitch of the gap gradually decreases from near to far along the extending direction.

[0012] In one embodiment, the main support rod is provided with a first through hole through which a wire can pass. The wire can sequentially pass through the first through hole and the gap. Among them, the wire between the gap and the first through hole is located outside the ablation member, and the rest is located inside. The length of the wire located outside is less than the length of the wire located inside.

[0013] In one embodiment, the pushing part further includes a connecting part having a preset axial extension length. The proximal ends of the plurality of connecting arms are simultaneously connected to the distal end of the connecting part. A plurality of recessed parts are concavely provided on the outer surface of the connecting part, and the plurality of recessed parts are spaced apart along the axial direction and / or the circumferential direction of the connecting part.

[0014] In one embodiment, the ablation device further includes a pushing tube and a sleeve, and the distal end of the pushing tube is axially opposite to the proximal end of the pushing part;

[0015] The sleeve is sleeved on the pushing tube and the pushing part at the same time. The sleeve is relatively fixed to the pushing tube. An inner part of the sleeve extends into the recessed part so that the sleeve is relatively fixed to the connecting part, thereby realizing the relative fixation among the sleeve, the pushing tube and the pushing part.

[0016] In one embodiment, the connecting part of the pushing part is relatively fixed to the sleeve. A plurality of the connecting arms are placed in the sleeve and can move circumferentially within the sleeve.

[0017] In one embodiment, the recessed part includes arc-shaped notches formed around the circumference of the connecting part. A plurality of the arc-shaped notches are arranged at intervals along the length direction of the connecting part. The plurality of arc-shaped notches arranged at intervals are spirally arranged on the outer circumference of the connecting part.

[0018] In one embodiment, the ablation device further includes an outer sheath tube sleeved outside the pushing part. The outer sheath tube and the pushing part can move axially relative to each other so that the ablation member at the distal end of the pushing part can be retracted / extended from the outer sheath tube; wherein, the ablation member is eccentrically arranged relative to the outer sheath tube so that when the ablation member is retracted into the outer sheath tube, the ablation member can be unevenly squeezed circumferentially.

[0019] In one embodiment, the ablation device further includes a pushing tube. A first cavity and a second cavity are formed in the pushing tube. The second cavity is disposed substantially in a crescent shape offset on the side of the first cavity.

[0020] By connecting a plurality of circumferentially spaced connecting arms to the ablation member, when the ablation member axially moves into the sheath, since the strength at the connection between the two is reduced, it is more convenient to insert into the sheath. At the same time, since each connecting arm is independent of each other and each connecting arm spaced independently has a certain circumferential movement space, when the ablation member is radially constrained, the connecting arms connected to it can move circumferentially, and this movement can further form a tendency of circumferential rotational insertion into the sheath, so that the ablation member can be inserted into the sheath more easily and smoothly. In addition, the circumferential movement of the connecting arms is more conducive to driving the deformation unit at the distal end to move and form an interleaved shape, thereby further reducing the problem of continuous opposing at the distal end. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of an existing ablation device;

[0022] Figure 2 is a schematic structural diagram of an exemplary ablation device of the present invention;

[0023] Figure 3 is a three-dimensional schematic diagram of the support skeleton of an exemplary ablation device of the present invention;

[0024] Figure 4 A top view schematic diagram of the support skeleton of the exemplary ablation device of the present invention;

[0025] Figure 5 A structural schematic diagram of a deformation unit in the exemplary ablation device of the present invention;

[0026] Figure 6 A structural schematic diagram of two adjacent deformation units in the exemplary ablation device of the present invention;

[0027] Figure 7 A structural schematic diagram of a first deformation part of a deformation unit in the exemplary ablation device of the present invention adjacent to a second deformation part of an adjacent deformation unit, that is, a structural schematic diagram of units in the same group;

[0028] Figure 8 is Figure 7 A structural schematic diagram of the first deformation part in

[0029] Figure 9 is Figure 7 A structural schematic diagram of the second deformation part in

[0030] Figure 10 is Figure 7 An enlarged schematic diagram of part A in

[0031] Figure 11 A structural schematic diagram of the unequal rod diameters of two adjacent first deformation parts and second deformation parts in the exemplary ablation device of the present invention;

[0032] Figure 12 is Figure 11 A top view schematic diagram of the support skeleton in

[0033] Figure 13 A structural schematic diagram of the different radial angles of deviation of the distal ends of two adjacent first deformation parts and second deformation parts in the exemplary ablation device of the present invention;

[0034] Figure 14 A structural schematic diagram of the non-equidistant arrangement of electrodes on two adjacent first deformation parts and second deformation parts in the exemplary ablation device of the present invention;

[0035] Figure 15 A schematic diagram of the outer peripheral side and the pushing part of the exemplary ablation device of the present invention;

[0036] Figure 16 A schematic diagram of the arrangement of the wire of the exemplary ablation device of the present invention;

[0037] Figure 17 A partial structural schematic diagram of the main support rod of the exemplary ablation device of the present invention;

[0038] Figure 18 is Figure 15 An enlarged schematic view of part B in

[0039] Figure 19 A partial structural schematic view of a wire groove provided on the main support rod of an exemplary ablation device of the present invention;

[0040] Figure 20 A partial schematic view of an electrode of an exemplary ablation device of the present invention provided on a support skeleton;

[0041] Figure 21 A partial structural schematic view of an electrode of an exemplary ablation device of the present invention provided on an adherent portion of a deformation unit;

[0042] Figure 22 A partial structural schematic view of an exemplary ablation device of the present invention including a push tube and an outer sheath tube;

[0043] Figure 23 A partial structural schematic view of an ablation member of an exemplary ablation device of the present invention placed outside the distal end of an outer sheath tube;

[0044] Figure 24 A structural schematic view of an exemplary ablation device of the present invention including a cooling component;

[0045] Figure 25 A cross-sectional view of a cooling component and a wire of an exemplary ablation device of the present invention passing through a push tube;

[0046] Figure 26 is Figure 22 An enlarged schematic view of part C in, which is a structural schematic view of a push portion of an exemplary ablation device of the present invention;

[0047] Figure 27 A schematic view of a concave portion on a push portion of an exemplary ablation device of the present invention being spiral;

[0048] Figure 28 A structural schematic view of a push portion, a push tube and a sleeve of an exemplary ablation device of the present invention. Detailed implementation manners

[0049] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0050] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude 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 to be construed as necessarily requiring them to be performed in the particular order described or illustrated, unless an execution order is explicitly stated. It should also be understood that additional or alternative steps may be used.

[0051] Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly dictates otherwise, terms such as "first", "second", and other numerical terms when used herein do not imply an order or sequence. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the example embodiments.

[0052] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures, such as "inner", "outer", "inner side", "outer side", "below", "beneath", "above", "upper", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature will then be oriented "above" or "upper" another element or feature. Thus, 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 relationship descriptors used herein are interpreted accordingly.

[0053] In addition, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body or a delivery device that delivers the medical device that is closer to the operator is generally called the "proximal end", and the end farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device or delivery device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is being delivered, and "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.

[0054] See also Figure 1 , which is a schematic diagram of an ablation device previously proposed by the applicant. Combined with the accompanying drawings and the relevant documents disclosed, it can be seen that the ablation device 100' can well adapt to the target tissue morphology and achieve good fit with the target tissue. However, for this ablation device 100', the applicant found in the operation and experimental process that since the support frame of the ablation device is usually formed by cutting, the rod diameters of each part of the support frame after cutting are basically the same, and the support strength between adjacent units is basically balanced, which results in the existence of the front end bending parts of the adjacent support units 10' when the electrode support unit 10' is sheathed (such as Figure 1 The phenomenon that the sheath is pushed together at A' in the figure not only requires greater force to retract the sheath, but also is prone to breakage at the top, which undoubtedly increases the difficulty and potential risk of sheathing. Based on this, the applicant further proposes an optimized solution on this basis to at least solve the problem of easy breakage caused by "pushing" together.

[0055] In view of this, see Figure 2 The present invention exemplarily provides an ablation device 1000, wherein the ablation device 1000 includes an ablation component 100 and a push portion 200, wherein the proximal end of the ablation component 100 is connected to the distal end of the push portion 200. The ablation component 100 has a first state in which it self-expands into a funnel shape when not constrained, and a second state in which it deforms and gathers when subject to radial constraints. The ablation component 100 of the present invention can reach a preset position and self-expand with the axial movement of the push portion 200, and can deform and gather into a second state of contraction based on the radial constraint force received with the axial movement of the push portion 200. Among them, Figure 2 The ablation component 100 is in the first state of self-expanding in a funnel shape when it is not constrained. It should be noted that the funnel shape defined in the present invention is only a general description of the expanded form of the ablation component 100, and does not mean that the inner surface or outer surface after expansion must be on the same circumference, and can be on the same circumference or different circumferences, for example, they can be on the same circumference, or they can be staggered front and back, or they can be covered in sequence front and back like petals, etc.

[0056] Continue to refer to Figure 2, the ablation member 100 includes a support framework 10, which has a first state of self-unfolding into a funnel shape when unconstrained and a second state of deforming and converging when radially constrained. The explanation of being in a funnel shape is as described above. Additionally, in other embodiments, the ablation member 100 further includes a wire 30 and an electrode 20. The electrode 20 is provided on the support framework 10, and the wire 30 extends from the proximal end towards the distal end and is connected (electrically connected) to the electrode 20 on the support framework 10. Exemplarily, the support framework 10 is integrally formed with the pushing portion 200, for example, by cutting and shaping, but is not limited thereto.

[0057] Referring to Figures 2 to 7 As shown, the support framework 10 includes a plurality of deformation units 11 on the distal side. The plurality of deformation units 11 are circumferentially enclosed. The circumferential enclosure does not necessarily mean that they are opposite to each other and on the same circumferential plane. It includes adjacent ones opposite to each other on the same circumferential plane, and can also be, for example, an enclosure formed by being radially offset front and back, or circumferentially offset front and back and covering each other. As Figure 3 and Figure 4 shown, the plurality of deformation units 11 are located between two rings Z1 and Z2 and are circumferentially enclosed within this region. Among them, the structure within an S1 region between the two rings Z1 and Z2 is one deformation unit 11, and two adjacent S1 regions form an S2 region, that is, the structure within an S2 region is two adjacent deformation units 11. The circumferentially enclosed plurality of deformation units 11 are adjacent to each other and can each deform independently relative to the adjacent deformation unit 11. That is, the two adjacent deformation units 11 within the S2 region can deform independently relative to each other. As Figure 5 shown, one deformation unit 11 within an S1 region includes a first deformation portion 11a and a second deformation portion 11b that are connected in the circumferential direction. As Figure 6 shown, for two adjacent deformation units 11 within an S2 region, the first deformation portion 11a of one deformation unit 11 is adjacent to the second deformation portion 11b of the adjacent deformation unit 11. The first deformation portion 11a of one deformation unit 11 and the second deformation portion 11b of the adjacent deformation unit 11 form a group of same-group units. That is, as Figure 7 shown in the region S3 in. It should be noted that the dashed lines in the drawings of the present invention are only line structures added for clearly illustrating the multi-unit structure of the present invention and do not belong to the structure of the ablation device itself.

[0058] To solve the above problems, the present invention proposes to define that the structures of two adjacent first deformation portions 11a and second deformation portions 11b in the same group are the same or different; when the structures of two adjacent first deformation portions 11a and second deformation portions 11b are the same, in order to avoid the "top" problem in the prior art, it is defined that the support strengths of the first deformation portion 11a and the second deformation portion 11b in the same group are both unevenly arranged, aiming to break the self-support balance of a single deformation portion and construct local deformation in addition to its self-support, so as to avoid continuous "top" through the local deformation of the two deformation portions in the same group. And / or, the present invention also proposes another solution, which is to define that the radial angles of the distal ends of two adjacent first deformation portions 11a and second deformation portions 11b in the same group are different, that is, the two adjacent deformation portions in the same group are misaligned to avoid "top" when gathering.

[0059] The present invention aims to optimize and change the structure of the deformation portions in the deformation unit, so as to at least weaken or eliminate the supporting force between the two deformation portions in the same group when subjected to radial constraints, so that under the same acting force, compared with the prior art, at least one of the adjacent first deformation portion and the second deformation portion in the present invention is more likely to deform, and / or the two are more likely to be misaligned, so as to avoid being "topped" together and causing damage through deformation and / or misalignment, reduce the risk, and at the same time reduce the external force required for sheath retraction, reducing the difficulty of sheath retraction. It can be understood that for the innovative essence of the present invention, compared with the circumferential enclosure of multiple deformation units in the circumferential direction in the prior art solution, when the sheath is retracted, multiple units form a situation of "topping" each other in a circumferential circle. The most basic optimization of the present invention is to at least improve the local part. For example, at least optimize one group of adjacent deformation portions in the circumferential direction to at least release the supporting force in the circumferential direction through one group. Of course, in order to improve the effect, multiple groups or all groups can be optimized. For this, it can be selectively set according to actual needs, and no limitation is made thereto. Among them, the "deformation" of the present invention refers to the degree of morphological change under the same acting force. The "adjacent" in the present invention is only a relative position relationship, adjacent but not connected at the relative position.

[0060] Referring to Figures 6 to 10 As shown, the first deformation portion 11a includes a first wall-attaching portion a1 extending in the circumferential direction and a first support arm a2 connected to the end of the first wall-attaching portion a1; the second deformation portion 11b includes a second wall-attaching portion b1 extending in the circumferential direction and a second support arm b2 connected to the end of the second wall-attaching portion b1. Both the first support arm a2 and the second support arm b2 extend along the extending direction of the ablation member 100. Preferably, in order to avoid stress concentration and form a transitional compliant deformation, the first wall-attaching portion a1 and the first support arm a2 are arc-connected, and the second wall-attaching portion b1 and the second support arm b2 are arc-connected. In other embodiments, such as Figures 8 to 10As shown, the first support arm a2 includes a first section a21 and a second section a22 connected along its extending direction. The distal end of the first section a21 is connected to the end of the first wall-attaching portion a1. The second support arm b2 includes a third section b21 and a fourth section b22 connected along its extending direction. The distal end of the third section b21 is connected to the end of the second wall-attaching portion b1.

[0061] For the solution of optimizing two deformation parts in the same group of units in the present invention, the following will be described with examples in conjunction with the drawings. It should be noted that in the following multiple solutions, under the condition of no structural conflict, selective combination can be carried out to solve the technical problems mentioned in this application.

[0062] Example 1

[0063] In the first embodiment 1, the structures of two adjacent first deformation parts 11a and second deformation parts 11b are the same or different, that is, the structures of two adjacent deformation parts in the same group of units are the same or different.

[0064] Example 1.1

[0065] In the first sub-embodiment 1.1, the structures of two adjacent first deformation parts 11a and second deformation parts 11b are the same, that is, the structures of two adjacent deformation parts in the same group of units are the same.

[0066] In this embodiment, the structures of two adjacent first deformation parts 11a and second deformation parts 11b are the same. At this time, if two adjacent deformation parts are adjacent and opposite, it is necessary to set the support strengths of the two unevenly, aiming to break the self-support balance of a single deformation part, construct local deformation in addition to its own support, and avoid continuous "butting" through the local deformation of two deformation parts in the same group. That is, deformation and dislocation are achieved through the imbalance inside each of them.

[0067] As an implementation manner of unevenly setting the support strengths of both the first deformation part 11a and the second deformation part 11b, holes can be drilled in the first deformation part 11a and the second deformation part 11b to change the unevenness of their support strengths by drilling holes. For example, holes are drilled on the distal sides of the two, so that the support strengths of the distal sides of the two are reduced, while the support strengths of their respective proximal sides remain unchanged, breaking the self-support balance of the original single deformation part, constructing local deformation on the distal sides while ensuring the support of their respective proximal sides. When the ablation member 100 is radially constrained, the distal sides of the two deform and displace preferentially under the support of their respective proximal sides, thereby reducing the circumferential abutting force. Of course, for example, the hole density can also be large on the distal sides of the two, the support strength is reduced more, while the hole density is small on the proximal sides, and the support strength is reduced less, as long as it can achieve preferential deformation and dislocation of the distal sides when being constrained.

[0068] As another implementation manner in which the support strengths of the first deformation part 11a and the second deformation part 11b are both unevenly set, it can be achieved by improving the rod diameters of two adjacent deformation parts in the same family unit, so that the rod diameters of the first deformation part 11a and the second deformation part 11b are both unevenly set, thereby breaking the self-support balance of the original single deformation part. For example, as Figures 3 to 10 shown, the rod diameters of the distal ends of two adjacent first deformation parts 11a and second deformation parts 11b can be made smaller than the rod diameters of their respective proximal ends, so that the deformation capabilities of the distal ends of the first deformation part 11a and the second deformation part 11b are both greater than the deformation capabilities of their respective proximal ends. When the ablation member 100 is radially constrained, the distal ends of the two deform first and are misaligned under the support of their respective proximal ends, thereby reducing the continuous resistance in the circumferential direction.

[0069] As Figure 10 shown, specifically, the first deformation part 11a includes a first wall-adhering part a1 extending in the circumferential direction and a first support arm a2 connected to the end of the first wall-adhering part a1, and the second deformation part 11b includes a second wall-adhering part b1 extending in the circumferential direction and a second support arm b2 connected to the end of the second wall-adhering part b1. The rod diameters of the first wall-adhering part a1 and the second wall-adhering part b1 are respectively smaller than the maximum rod diameters of the first support arm a2 and the second support arm b2, thereby reducing the support strength of the wall-adhering part and making it relatively easier to deform. When the ablation member 100 is radially constrained, the distal wall-adhering parts of the two deform first and are misaligned under the support of their respective support arms, thereby reducing the continuous resistance in the circumferential direction.

[0070] Furthermore, in order to avoid the damage of the deformation part itself due to the large difference in the strength change at the strength change point caused by the uneven setting of the support strength, when the first support arm a2 includes a first section a21 and a second section a22 connected along its extending direction, and the second support arm b2 includes a third section b21 and a fourth section b22 connected along its extending direction, the rod diameters of the first section a21 and the third section b21 are respectively smaller than the rod diameters of the second section a22 and the fourth section b22 to form a transitional support change and form a compliant transitional deformation. At this time, the support strengths of the first section a21 and the third section b21 become weaker, and the relative contact parts of the first section a21 and the third section b21 are also prone to deformation, so that the first section a21, the first wall-adhering part a1, the third section b21, and the second wall-adhering part b1 can all deform better, thereby enabling the proximal side of the support arm to have strong support, and the other end of the support arm forms a transition with the wall-adhering part to avoid damage at the connection between the two.

[0071] Among them, the rod diameter of the first wall-attaching portion a1 is not greater than that of the first section a21, and the rod diameter of the second wall-attaching portion b1 is not greater than that of the third section b21. Preferably, in order to avoid bending deformation at the connection between the first wall-attaching portion a1 and the connected first section a21, and between the second wall-attaching portion b1 and the connected third section b21 due to a large difference in support strength, the rod diameter of the first wall-attaching portion a1 is approximately equal to that of the first section a21, and the rod diameter of the second wall-attaching portion b1 is approximately equal to that of the third section b21, so as to ensure the structure and form a transitional compliant deformation. In a further optimized embodiment, in order to form effective support at the proximal end and form a transition of support strength, the rod diameters of the second section a22 and the fourth section b22 gradually increase from far to near. This design is also more conducive to sheath retraction.

[0072] In this embodiment, when the structures of two adjacent first deformation portions 11a and second deformation portions 11b in the same group unit are the same, by unevenly setting the support strengths of the first deformation portion 11a and the second deformation portion 11b in the same group, the self-support balance of a single deformation portion is broken, and local deformation is constructed in addition to its self-support, so as to avoid continuous "pushing against" through the local preferential deformation of the two deformation portions in the same group. Compared with the prior art, under the same conditions, the first deformation portion 11a and the second deformation portion 11b of this embodiment preferentially deform locally, thereby weakening the relative confrontation.

[0073] Example 1.2

[0074] In Embodiment 1.2 of this example, the structures of two adjacent first deformation portions 11a and second deformation portions 11b are different, that is, the structures of two adjacent deformation portions in the same group unit are different.

[0075] Embodiment 1.2.1

[0076] In this embodiment, the structures of two adjacent first deformation portions 11a and second deformation portions 11b are different, and the support strengths between the two adjacent first deformation portions 11a and second deformation portions 11b are unevenly set, so that the deformation ability of the deformation portion with a small support strength is greater than that of the deformation portion with a large support strength. This method aims to break the support balance between two adjacent deformation portions by forming a support strength difference, so that one of them preferentially deforms to avoid continuous "pushing against".

[0077] Refer to Figure 11 and Figure 12As shown, as an embodiment of the uneven support strength setting between two adjacent first deformable parts 11a and second deformable parts 11b, the first deformable part 11a includes a first wall-attaching part a1 extending in the circumferential direction and a first support arm a2 connected to the end of the first wall-attaching part a1; the second deformable part 11b includes a second wall-attaching part b1 extending in the circumferential direction and a second support arm b2 connected to the end of the second wall-attaching part b1, and the rod diameter of the first support arm a2 is different from the rod diameter of the second support arm b2. The difference in rod diameter, for example, the rod diameter of the first support arm a2 is smaller than the rod diameter of the second support arm b2, leads to different support strengths between the first deformable part 11a and the second deformable part 11b in the same group of units, so that the deformation degrees of the two are different. When the ablation component 100 is subject to radial constraints, the one with smaller support strength is deformed first and the two are dislocated, thereby reducing the continuous offset in the circumferential direction, and the one with larger support strength is also deformed as the radial constraint force increases.

[0078] The present embodiment shows that by changing the structures of the two adjacent first deformation parts 11a and the second deformation parts 11b in the same family of units, the two structures are made different, the support strength of the two is changed, and the difference in the support strength of the two is increased, so that one of them is deformed first, breaking the relative balance, thereby reducing the circumferential abutment force and avoiding continuous abutment in the circumferential direction.

[0079] Example 1.2.2

[0080] The structures of the two adjacent first deformation portions 11a and the second deformation portions 11b in this embodiment are different. At least one of the two adjacent first deformation portions 11a and the second deformation portions 11b is provided with a guide structure and / or a guide member (not shown) at the relative position thereof, so that when the ablation element 100 is radially constrained, the first deformation portion 11a and the second deformation portion 11b can produce radial displacement under the guiding action of the guide structure and / or the guide member.

[0081] As an embodiment, illustratively, the guide structure includes a first inclined surface inclined at the side of the first deformable portion 11a and a second inclined surface arranged at the side of the second deformable portion 11b and matching with the first inclined surface. When the ablation member 100 is radially constrained, the first deformable portion 11a and the second deformable portion 11b are deformed and misaligned under the radial constraint force, thereby reducing the circumferential abutment force.

[0082] In this embodiment, by changing the structures of the opposite sides of two adjacent first deformation parts 11a and second deformation parts 11b in the same family of units, a misalignment occurs between the two when they are radially constrained, thereby breaking the relative balance and reducing the continuous offset in the circumferential direction.

[0083] Example 2

[0084] In this Embodiment 2, the radial angles by which the distal ends of two adjacent first deformation portions 11a and second deformation portions 11b deviate are different, that is, the radial angles by which the distal ends of the two deformation portions in the same group deviate are different.

[0085] When the radial angles by which the distal ends of two adjacent first deformation portions 11a and second deformation portions 11b in this embodiment deviate are different, the two adjacent first deformation portions 11a and second deformation portions 11b are arranged in relative dislocation in the radial direction. At this time, the distal end of the first deformation portion 11a and the distal end of the second deformation portion 11b in the same group are adjacent but not circumferentially opposite. When the two adjacent first deformation portions 11a and second deformation portions 11b are radially constrained, the distal ends of the two are not deformed on the same circumference at the same time in the front-back dislocation, thereby eliminating the state of the distal sides abutting against each other. In this Embodiment 2, since the state of abutting against each other in the circumferential direction has been eliminated by the way of front-back dislocation, therefore, the structures of the two adjacent first deformation portions 11a and second deformation portions 11b in this embodiment can be the same or different, and the support strengths can also be the same or different.

[0086] Refer to Figure 13 As shown, as an implementation manner, the distal end side of the first deformation portion 11a is inclined inward / outward relative to the second deformation portion 11b, so that when the ablation member 100 is radially constrained, at least the distal end sides of the first deformation portion 11a and the second deformation portion 11b are misaligned inside and outside and are not deformed on the same circumference at the same time, thereby eliminating the circumferential abutting force between the distal ends of the two when the ablation member 100 is radially constrained and avoiding the "butting" problem.

[0087] Example 3

[0088] The structures of the two adjacent first deformation portions 11a and second deformation portions 11b in this Embodiment 3 can be the same or different, that is, the structures of the two adjacent deformation portions in the same group can be the same or different.

[0089] Refer to Figure 14 As shown, this embodiment is an optimization based on the ablation member 100 including the electrode 20. As described above, the ablation member 100 further includes a wire 30 and an electrode 20. The electrode 20 is provided on the support frame 10, and the wire 30 extends from the proximal end to the distal end and is connected to the electrode 20 provided on the support frame.

[0090] As Figure 14 As shown, the electrode 20 includes a first electrode 20a and a second electrode 20b respectively provided on two adjacent first deformation portions 11a and second deformation portions 11b. The first electrode 20a is provided on the first wall-attaching portion a1, and the second electrode 20b is provided on the second wall-attaching portion b1. The distance between the first electrode 20a and the end of the first deformation portion 11a is different from the distance between the second electrode 20b and the end of the second deformation portion 11b. Here, the end refers to the end in the circumferential direction where the two adjacent deformation portions are opposite. AsFigure 14 As shown, the distance between the first electrode 20a and the end of the first deformation part 11a refers to the distance between the first electrode 20a and the end of the first wall-attaching part a1, and the distance between the second electrode 20b and the end of the second deformation part 11b refers to the distance between the second electrode 20b and the end of the second wall-attaching part b2. As shown in the partial enlarged view in Figure 14 , the distance on the left side is longer and the distance on the right side is shorter. This method adjusts the support strength of two adjacent deformation parts by the distance of the electrode setting, so that the support strengths of the two form a drop, so that one of them deforms and dislocates faster under the same acting force, thereby reducing the circumferential abutting force.

[0091] The solutions shown in the above embodiments all solve the problem of easy breakage caused by "butting" together in the existing ablation device. As mentioned above, the above embodiments are all exemplary descriptions for solving problems. Under the condition that the structures do not conflict, multiple embodiments can be selectively combined to obtain a new combined solution to solve this problem. The following will be based on any of the above embodiments to elaborate in detail on other components of the ablation device of the present invention, aiming to be exemplary or further optimized. Among them, the rod diameter of the present invention refers to the diameter when it is a cylindrical structure, and refers to the width in the circumferential direction when it is a cut flat shape. It should be understood that it is not limited thereto, and it can also be the conventional cognition of those skilled in the art.

[0092] As Figure 1 shown in the prior art in Figure 2 , Figure 3 and Figures 15 to 19 shown, in other embodiments of the present invention, in order to facilitate the convergence and the orderliness during convergence while forming an effective support, the support skeleton 10 further includes a plurality of main support rods 12, and the plurality of main support rods 12 are circumferentially spaced apart. The proximal end of each main support rod 12 is connected to the distal end of the pushing part 200, and the distal end of each main support rod 12 is simultaneously connected to the proximal ends of two adjacent first deformation parts 11a and second deformation parts 11b. When the deformation part includes a wall-attaching part and a support arm, the distal end of each main support rod 12 is simultaneously connected to the proximal ends of two adjacent support arms. Among them, when the first deformation part 11a includes a first wall-attaching part a1 extending in the circumferential direction and a first support arm a2 connected to the end of the first wall-attaching part a1, and the second deformation part 11b includes a second wall-attaching part b1 extending in the circumferential direction and a second support arm b2 connected to the end of the second wall-attaching part b1, the distal end of a main support rod 12 is simultaneously connected to the proximal end of the first support arm a2 and the proximal end of the second support arm b2.

[0093] See Figures 15 to 18, Further, the diameter of the main support rod 12 gradually decreases from far to near. The diameter of the main support rod 12 gradually tapers from far to near, which has a certain guiding effect and is conducive to staggering. At the same time, it is wider on the distal side connected to the support arm, which can form a strong support and improve the radial force. As Figure 17 shown, when the first support arm a2 includes a first section a21 and a second section a22 connected along its extending direction, and the second support arm b2 includes a third section b21 and a fourth section b22 connected along its extending direction, the distal end of a main support rod 12 is simultaneously connected to the proximal ends of the second section a22 and the fourth section b22. Exemplarily, when the diameters of the first section a21 and the third section b21 are respectively smaller than the diameters of the second section a22 and the fourth section b22, and the diameters of the second section a22 and the fourth section b22 gradually increase from far to near, the maximum ends of the proximal ends of the second section a22 and the fourth section b22 are connected to the maximum end of the distal end of a main support rod 12, and the widths at the connection are the same. This setting, for the main support rod 12, tapering towards the proximal side forms a certain guiding effect, facilitating sheath retraction, being conducive to staggering, and increasing the radial force; for the support arm, it forms a transition of the support strength towards the distal side, facilitating the formation of a compliant deformation; at the same time, a strong support strength is formed at the widest connection between the two, facilitating deployment.

[0094] Continue to refer to Figures 15 to 18 , In other embodiments, there is a gap 11c between the proximal sides of two adjacent first deformation parts 11a and second deformation parts 11b. On the one hand, this gap 11c can provide space for the first deformation part 11a and the second deformation part 11b to be misaligned when the ablation member 100 is radially constrained. On the other hand, this gap 11c can allow the wire 30 to pass through, so that the wire 30 can pass through this gap 11c, and at least a part of the wire 30 is arranged inside the ablation member 100, avoiding abrasion of the wire 30 located outside by the outer sleeve.

[0095] Further, in other embodiments, as Figure 17 and Figure 18As shown, the circumferential pitch of the gap 11c of the present invention gradually decreases in the extending direction from near to far, making the gap 11c roughly in the shape of a long strip of water droplets. This setting of the gap 11c makes the distance between the proximal sides of the first support arm a2 and the second support arm b2 large, while the distance decreases at the distal end, and even a state of abutment is formed at the distal end. The function of this setting is as follows. First, it ensures that there is a large misalignment space between the first support arm a2 and the second support arm b2 at the proximal side, which is more conducive to folding and retracting into the sheath when subjected to radial binding force, and is conducive to the minimum outer diameter setting. Second, the first support arm a2 and the second support arm b2 form a circumferential abutment or near abutment at the distal side, which is conducive to the two quickly acting on each other to generate deformation and misalignment when subjected to radial binding force. At the same time, it can also maximize the circumferential perimeter of the wall-attaching part of the ablation member 100, which is beneficial to ablation. Third, when the wire 30 passes through the gap 11c, there is a large space at the proximal end for the wire 30 to pass through. At the same time, since the wire 30 continues to extend and connect to the electrode 20 on the wall-attaching part after passing through the gap 11c, it needs to move to a certain extent with the gathering and unfolding of the ablation member 100. And this setting where the circumferential pitch gradually decreases from the proximal end to the distal end avoids the wire 30 forming a hard abutment with the support frame 10 at the gap. During the process of the wall-attaching part driving the electrode 20 to move towards the distal direction, it extends towards the distal direction through the through hole of the gap 11c, so that the wire 30 in the gap 11c can follow the electrode 20 to move towards the distal direction, thereby enabling the wire 30 to adapt to the displacement of the electrode 20 driving the wire 30 to move in the moving direction after the wall-attaching part is closed, so that the wire 30 can move more smoothly even when it fits against the inner wall / outer wall of the ablation member 100 after passing through the large space at the proximal end. In addition, the water-drop-shaped gap 11c can also play a guiding role to a certain extent.

[0096] Continue to refer to Figures 15 to 18 , in other embodiments, a first through hole 121 for the wire 30 to pass through is further provided on the main support rod 12. The wire 30 can sequentially pass through the first through hole 121 and the gap 11c. A gap 11c and a first through hole 121 are provided on the support skeleton 10. The gap 11c and the first through hole 121 are arranged at intervals. The gap 11c is located on the proximal side of the support arm, and the first through hole 121 is located on the proximal side of the gap 11c. The wire 30 sequentially passes through the first through hole 121 and the gap 11c and is connected to the electrode 20. For example, in one embodiment, the wire 30 passes through from the radial inner side of the pushing part 200, the wire 30 fits against the inner wall of the support skeleton 10 and extends towards the distal end of the ablation member 100. The wire 30 passes through the first through hole 121 from the inner wall of the support skeleton 10, then extends from the radial outer side of the support skeleton 10 towards the gap 11c and passes through the gap 11c to enter the radial inner side of the support skeleton 10, and then bends towards the wall-attaching part to be connected to the electrode 20.

[0097] In this way, by providing a gap 11c and a first through-hole 121 in the support frame 10, after the wire 30 passes through the gap 11c and the first through-hole 121, the gap 11c and the first through-hole 121 can limit the wire 30. Moreover, since the gap 11c is located on the proximal side of the support arm and is close to the support arm, the wire 30 can be bent towards the wall-attaching portion after passing through the gap 11c, reducing the possibility that the wire 30 is clamped between the two support arms during the process of being received into the outer sheath tube 400 or released from the outer sheath tube 400. Thereby, it is possible to avoid damage to the wire 30 caused by the interleaved friction of the support arms, and prevent the insulation layer of the wire 30 from being damaged.

[0098] Preferably, the wire 30 between the gap 11c and the first through-hole 121 is located outside the ablation member 100, and the rest is located inside. The length of the wire 30 located outside is less than the length of the wire 30 located inside. Exemplarily, the interval distance between the gap 11c and the first through-hole 121 is defined to be <0.5 mm. It should be noted that there is a certain interval distance between the gap 11c and the first through-hole 121, and this interval distance is used to provide a bending space for threading the wire 30. However, the interval distance between the gap 11c and the first through-hole 121 cannot be too large. When the interval distance between the gap 11c and the first through-hole 121 is too large, it is easy to cause a floating wire of the wire 30 between the gap 11c and the first through-hole 121 during the sheath receiving process, increasing the probability that the insulation layer of the wire 30 is damaged by the friction of the sheath tube. Therefore, by setting the interval distance between the gap 11c and the first through-hole 121 to be <0.5 mm, on the basis of providing a certain threading bending space for the wire 30, it is possible to prevent the distance between the gap 11c and the first through-hole 121 from being too large and causing a floating wire of the wire 30.

[0099] As Figure 18 shown, a second through-hole 200a is provided at the distal end of the pushing portion 200. The second through-hole 200a is located on the proximal side of the first through-hole 121. The wire 30 sequentially passes through the second through-hole 200a, the first through-hole 121, and the gap 11c and is connected to the electrode 20. Among them, as Figure 2 and Figure 15As shown, the pushing part 200 includes a connecting part 202, and the second through hole 200a can be provided at the distal end of the connecting part 202. In other embodiments, the pushing part 200 of the present invention further includes a connecting arm 201 at the distal end. A plurality of connecting arms are circumferentially spaced around the connecting part 202, and the free ends of the plurality of connecting arms 201 are respectively connected to the proximal ends of the plurality of main support rods 12 one by one. Among them, when the connecting arm is provided at the distal end of the pushing part 200, the second through hole 200a can be provided on the connecting arm 201 located at the distal end of the connecting part 202. The plurality of connecting arms 201 are relatively independent of each other, and the adjacent connecting arms 201 can move relative to each other, which is beneficial to driving the movement of the edge of the distal deformation unit, beneficial to the formation of an interleaved shape, and also convenient for sheath retraction.

[0100] In this embodiment, the wire 30 passes through the second through hole 200a from the radially outer side of the support skeleton 10 and enters the support skeleton 10. The wire 30 extends along the inner wall of the support skeleton 10 towards the distal end direction. The wire 30 passes through the first through hole 121 and exits the radially outer side of the support skeleton 10, and then enters the support skeleton 10 from the radially outer side through the gap 11c. Thus, by providing the second through hole 200a on the distal end of the pushing part 200, the second through hole 200a and the first through hole 121 cooperate to limit the wire 30 on the radially inner side wall of the support skeleton 10. Therefore, most of the wire 30 can be attached to the inner wall of the support skeleton 10. On the one hand, during the sheath retraction process, it can avoid the wire 30 on different support skeletons 10 from being intertwined with each other, which causes difficulties in deploying the ablation member 100. On the other hand, it can also avoid the wire 30 from being scratched by the sheath tube, which causes damage to the insulating layer on the wire 30.

[0101] As Figure 19 shown, in other embodiments, a wire groove 122 can also be provided on the inner wall of the main support rod 12. The wire groove 122 extends from the proximal end of the main support rod 12 to the first through hole 121. At least a part of the wire 30 is accommodated in the wire groove 122. The wire 30 passes through the second through hole 200a and enters the wire groove 122, and then extends from the wire groove 122 to the first through hole 121. Thus, the wire 30 can be accommodated in the wire groove 122, reducing the loading volume of the ablation member 100.

[0102] As Figure 20 shown, in other embodiments, the wire 30 of this embodiment includes an exposed part 31. The exposed part 31 is located between the electrode 20 and the support skeleton 10 and at least partially fits with the inner wall of the electrode 20.

[0103] Combined Figure 20 and Figure 21As shown, the wire 30 includes a conductive layer 30a and an insulating layer 30b, and the insulating layer 30b is coated on the outside of the conductive layer 30a. The wire 30 includes an exposed portion 31 and a main body portion 32. The exposed portion 31 and the main body portion 32 are connected. The exposed portion 31 refers to the part where the insulating layer 30b is not provided to expose the conductive layer 30a. The exposed portion 31 is located between the electrode 20 and the wall-attaching portion of the support frame 10, and the exposed portion 31 is in contact with the inner wall of the electrode 20. The main body portion 32 refers to the part where the insulating layer 30b is provided outside the conductive layer 30a. One end of the wire 30 is electrically connected to an external power source. The conductive layer 30a can be made of one or more of materials such as copper, aluminum, silver, or gold. The inner wall of the electrode 20 can be in contact with the exposed portion 31 entirely or partially.

[0104] During the operation of the ablation device 100, the power source delivers current to the wire 30, and the current passes through the exposed portion 31 to communicate with the electrode 20. After the electrode 20 is energized, an ablation field is formed to achieve ablation of the target site. After the ablation is completed, the conduction between the power source and the wire 30 is disconnected, and the electrode 20 stops emitting the ablation field, thereby stopping the ablation.

[0105] In this way, by arranging the electrode 20 on the wall-attaching portion of the support frame 10, the support frame 10 can press the electrode 20 against the tissue to be ablated. Then, since the wire 30 includes the exposed portion 31, and the exposed portion 31 is located between the electrode 20 and the support frame 10, at least part of the exposed portion 31 is in contact with the inner wall of the electrode 20, so that the inner wall of the electrode 20 is in contact with the conductive layer 30a of the wire 30. Compared with the prior art in which the electrode 20 is connected to the wire 30 only at one or both ends, the conductive area between the electrode 20 and the wire 30 is increased, facilitating the transfer of current and increasing the heating rate of the electrode 20, so as to reduce the ablation time and reduce the pain of the patient.

[0106] See Figure 22 , the ablation device 1000 further includes an outer sheath 400 sleeved outside the pushing portion 200. The outer sheath 400 and the pushing portion 200 can move axially relative to each other, so that the ablation member 100 located at the distal end of the pushing portion 200 can be received / extended from the outer sheath 400. In other embodiments, the ablation member 100 is eccentrically arranged relative to the outer sheath 400, that is, the ablation member 100 and the outer sheath 400 are not coaxially arranged. As Figure 23 shown, the central axis of the ablation member 100 is X1, and the central axis of the outer sheath 400 is X2. The central axis X1 is eccentrically located on one side of the central axis X2. In this way, when the ablation member 100 is received into the outer sheath 400, due to the eccentric arrangement of the ablation member 100 relative to the outer sheath 400, the forces received by the ablation member 100 in the circumferential direction from the outer sheath 400 are different, and there is a greater local force. Then, the corresponding deformation unit 11 is slightly inclined inward compared with other deformation units, which is more conducive to forming a dislocation, facilitating the reduction of circumferential abutment and timely sheath insertion.

[0107] Referring to Figure 22 as shown, in order to operate the pushing part 200 proximally, the exemplary ablation device 1000 of the present invention further includes a pushing tube 300. The distal end of the pushing tube 300 is connected to the proximal end of the pushing part 200, and the proximal end of the pushing tube 300 is for the operator to operate. Exemplarily, as Figure 22 and Figure 25 shown, a first cavity 300a and a second cavity 300b are formed in the pushing tube 300. In other embodiments, the second cavity 300b is disposed substantially in a crescent shape and offset on the side of the first cavity 300a. The first cavity 300a can be used to introduce coolant, and the second cavity 300b can be used for the wire 30 to pass through. The wire 30 is disposed in the second cavity 300b and at least part of it passes out of the distal end of the pushing tube 300. Continuing to refer to Figure 22 and Figure 25 , the cross-section of the first cavity 300a of the present invention is substantially circular, the cross-section of the second cavity 300b is substantially crescent-shaped, and the second cavity 300b is offset on the side of the first cavity 300a, making the pushing tube 300 flat. Its cross-section substantially includes two opposite arcs and planes connecting the two opposite arcs respectively. This setting not only realizes the double-cavity design, but also facilitates minimizing the radial dimension of the pushing tube 300, so that the entire delivery outer diameter of the entire ablation device can be minimized. More importantly, when it is connected to the ablation member 100 at its distal end, it is beneficial for the ablation member 100 to be eccentrically disposed relative to the outer sheath tube 400. Exemplarily, when the pushing part 200 includes a connecting part 202, the connecting part 202 is a tubular structure, and the lumen of the connecting part 202 communicates with both the first cavity 300a and the second cavity 300b of the pushing tube 300.

[0108] Referring to Figure 24 and Figure 25 , the ablation device 1000 further includes a cooling assembly 500. The cooling assembly 500 is located radially inside the support frame 10. A first cavity 300a and a second cavity 300b are formed in the pushing tube 300. The first cavity 300a and the second cavity 300b are arranged along the axial direction of the pushing tube 300. The wire 30 is disposed in the second cavity 300b, and the first cavity 300a communicates with the cooling assembly 500.

[0109] The cooling assembly 500 includes a cooling balloon 501 and a delivery conduit 502. The distal end of the cooling balloon 501 is closed, and the proximal end of the cooling balloon 501 is connected to and in communication with the delivery conduit 502. The cooling balloon 501 is located radially inside the support framework 10. Spray holes are formed in the sidewall of the cooling balloon 501. After the fluid enters the cooling balloon 501, it sprays out from the spray holes to cool the electrode 20. One end of the delivery conduit 502 is connected to the cooling balloon 501, and the other end of the delivery conduit 502 passes out of the first cavity 300a. It can be understood that in another embodiment, the cooling assembly 500 includes a plurality of cooling conduits. The plurality of cooling conduits are disposed in the first cavity 300a, and the distal ends of the cooling conduits pass out of the distal end of the first cavity 300a and are bent toward the radially outer side of the support framework 10. The fluid sprays out from the distal ends of the cooling conduits to cool the electrode 20. It can be understood that when the pushing portion 200 includes a connecting portion 202 and the connecting portion 202 is a tubular structure, the cooling assembly 500 passes through the first cavity 300a and the second cavity 300b and then passes through the tubular connecting portion 202 of the pushing portion 200 and a plurality of circumferentially arranged connecting arms 201 and then extends out.

[0110] In the ablation device of the present invention, the structures of two adjacent first deformation portions and second deformation portions in the same group of units are defined to be the same or different; when the structures of two adjacent first deformation portions and second deformation portions are the same, in order to avoid the "pushing" problem in the prior art, the support strengths of the first deformation portion and the second deformation portion in the same group of units are both unevenly arranged, aiming to break the self-support balance of a single deformation portion and construct local deformation in addition to its self-support, so as to avoid continuous "pushing" through the local deformation of the two deformation portions in the same group. When the structures are different, the support strengths of the two are changed by the structure, and the difference in the support strengths of the two is increased, so that one of them deforms preferentially, breaking the relative balance, thereby avoiding continuous abutment in the circumferential direction. And / or the radially deviated angular degrees of the distal ends of two adjacent first deformation portions and second deformation portions in the same group of units are defined to be different, that is, the two adjacent deformation portions in the same group of units are misaligned to avoid "pushing" when gathering.

[0111] The ablation device of the present invention optimizes and changes the structure of the deformation portions in the deformation unit to weaken or eliminate the supporting forces between the two deformation portions in the same group of units when being radially constrained, so that under the same acting force, compared with the prior art, at least one of the adjacent first deformation portion and the second deformation portion in the present invention is more likely to deform, and / or the two are more likely to be misaligned, thereby avoiding being "pushed" together to cause breakage through deformation and / or misalignment, reducing the risk, and at the same time reducing the external force required for sheath retraction and reducing the difficulty of sheath retraction.

[0112] Regarding the background technology of the present application, when the umbrella-shaped electrode support unit 10' enters the sheath tube initially, at the proximal end of the support unit (i.e., Figure 1At B' in the figure, the outer sheath 400' will be rigidly squeezed. At this time, it is not only difficult to enter the sheath, which may cause damage here, but also the movement of the support unit 10' at this point is limited in the state of being offset, which is not conducive to the formation of an interlaced shape of the umbrella-like structure. This also invisibly aggravates the problem of the distal end of the support unit. The present invention will exemplarily solve it through the following embodiments. It should be noted that the structures of the following embodiments can be arbitrarily combined without conflict with the aforementioned ones, and the structures and effects of the specific components involved in the following embodiments can also refer to the aforementioned ones.

[0113] The present invention also exemplarily proposes an ablation device 1000, including a pushing part 200 and an ablation component 100 connected to the distal end of the pushing part 200, wherein the ablation component 100 has a first state in which it is self-expanded and funnel-shaped when not constrained, and a second state in which it is deformed and gathered when radially constrained; the ablation component 100 includes a support frame 10, and the support frame 10 includes a plurality of deformation units 11 located at the distal end side, and the plurality of deformation units 11 are circumferentially enclosed, and the enclosed plurality of deformation units 11 are adjacent to each other and can be deformed independently relative to the adjacent deformation units 11. Among them, the various structures and effects of the ablation component 100 of this embodiment can refer to any of the aforementioned embodiments, and will not be repeated here.

[0114] The pushing portion 200 of this embodiment includes a plurality of connecting arms 201 disposed at the distal end. The plurality of connecting arms 201 are circumferentially spaced apart, and the free ends of the plurality of connecting arms 201 are respectively connected to the proximal ends of the plurality of deformation units 11 .

[0115] Exemplarily, each deformation unit 11 includes a first deformation part 11a and a second deformation part 11b that are circumferentially connected. A first deformation part 11a of each deformation unit 11 is adjacent to a second deformation part 11b of an adjacent deformation unit 11; the support skeleton 10 further includes a plurality of main support rods 12. The plurality of main support rods 12 are circumferentially spaced apart. The proximal end of each main support rod 12 is connected to the free end of a connecting arm 201, and the distal end of each main support rod 12 is simultaneously connected to the proximal ends of two adjacent first deformation parts 11a and second deformation parts 11b in two adjacent deformation units 11. Exemplarily, there is a gap 11c between the proximal sides of two adjacent first deformation parts 11a and second deformation parts 11b in two adjacent deformation units 11, and the circumferential pitch of the gap 11c gradually decreases from near to far along the extending direction. Exemplarily, the main support rod 12 is provided with a first through hole 121 through which a wire 30 can pass, and the wire 30 can sequentially pass through the first through hole 121 and the gap 11c. In other embodiments, the wire 30 between the gap 11c and the first through hole 121 is located outside the ablation member 100, and the rest is located inside. The length of the wire 30 located outside is less than the length of the wire 30 located inside. Among them, the structures and effects of the deformation unit 11, the first deformation, the second deformation part 11b, and the main support rod 12 in this embodiment can be referred to any of the foregoing embodiments, and will not be elaborated here.

[0116] Combined Figure 22 and Figure 26 As shown, in order to realize the connection between the pushing part 200 and the pushing tube 300, the pushing part 200 of this embodiment further includes a connecting part 202 having a preset axial extension length. The proximal ends of the plurality of connecting arms 201 are simultaneously connected to the distal end of the connecting part 202, and the proximal end of the connecting part 202 is connected to the distal end of the pushing tube 300. As an implementation manner, the connecting part 202 is a tubular structure, and the connecting part 202 and the pushing tube 300 are sleeved with each other to realize the connection. As another implementation manner, the connecting part 202 is a tubular structure. A recess 202a is concavely provided on the outer surface of the connecting part 202. The recess 202a penetrates through the tube wall of the connecting part 202. When the connecting part 202 is connected to the pushing tube 300, a hot-melt material enters the recess 202a by means of hot melting to realize the connection. Preferably, in order to improve the connection strength, a plurality of recesses 202a are provided. The plurality of recesses 202a all penetrate through the tube wall of the connecting part 202, and the plurality of recesses 202a are spaced apart along the axial direction and / or the circumferential direction of the connecting part 202.

[0117] Refer to Figure 22 and 28As shown, in this embodiment, in order to minimize the outer diameter of the entire ablation device 1000 while realizing the connection between the push tube 300 and the push part 200, the ablation device 1000 of this embodiment further includes a push tube 300 and a sleeve 600. The distal end of the push tube 300 is axially opposite to the proximal end of the push part 200. The sleeve 600 is sleeved on both the push tube 300 and the push part 200 at the same time. The sleeve 600 is relatively fixed to the push tube 300. A part of the inside of the sleeve 600 extends into the recess 202a to make the sleeve 600 relatively fixed to the connecting part 202, thereby realizing the relative fixation of the sleeve 600, the push tube 300, and the push part 200. This method can be realized by hot melting, such as Figure 28 As shown, the push part 200 and the push tube 300 are butted front and back, the sleeve 600 is sleeved outside the two, and then hot melted. The first section 601 of the sleeve 600 is fixedly connected to the push tube 300 after hot melting. The second section 602 of the sleeve 600 partially enters into a plurality of recesses 202a on the connecting part 202 after hot melting, thereby realizing the fixed connection between the sleeve 600 and the push part 200. The docking, sleeving, and hot melting methods of this embodiment not only realize the connection, but also facilitate the minimization of the outer diameter. Exemplarily, the push part 200 of the present invention and the support skeleton 10 of the ablation member 10 can be integrally formed, for example, by integrally cutting and heat setting. Materials such as nitinol alloy and stainless steel can be selected. The push tube 300, the sleeve 600, and the outer sheath tube 400 can be made of selected polymer materials. In particular, the push tube 300 and the sleeve 600 can be selected from polymer materials with good mutual welding performance at high temperatures to have good connection force after welding. Exemplarily, the push tube 300 can be selected as a nylon tube, the sleeve 600 can be selected as a pebax tube, and the outer sheath tube 400 can be selected as a PVDF tube. Of course, the materials and forming methods are not limited to this.

[0118] In other embodiments, the connecting part 202 of the push part 200 is relatively fixed to the sleeve 600, and a plurality of connecting arms 201 are placed in the sleeve and can move circumferentially within the sleeve. That is, the plurality of connecting arms 201 can move circumferentially within the third section 603 of the sleeve 600. That is to say, the third section 603 of the sleeve 600 will form axial support, but will not block and limit the circumferential direction of the plurality of connecting arms 201, thereby ensuring that the plurality of connecting arms 201 are still independent rods with circumferential freedom, so that the rods can move relative to each other, which is beneficial to driving the deformation unit 11 of the ablation member 10 to deform into an interleaved form.

[0119] Referring to Figure 26 and Figure 27 As shown, the recess 202a includes an arc-shaped notch formed around the circumference of the connecting part 202. A plurality of arc-shaped notches are arranged at intervals along the length direction of the connecting part 202. The plurality of arc-shaped notches arranged at intervals are spirally arranged on the outer circumference of the connecting part 202, such as Figure 27The spiral form L shown in [figure]. In other embodiments, the arc angles of the multiple arc-shaped notches gradually increase from the distal end to the proximal end; in other embodiments, the axial widths of the multiple arc-shaped notches gradually decrease from the distal end to the proximal end. In another embodiment, the spacing distances of the multiple arc-shaped notches gradually decrease from the distal end to the proximal end. The arc-shaped notches and the spiral arrangement in this embodiment can, on the one hand, effectively ensure the connection strength and axial support, forming stable connections and strong supports both axially and circumferentially, and ensuring the support and pushing force of the connecting part on the front-end support unit. On the other hand, it can form a certain bending performance, so that when the pushing tube 300 drives the pushing part 200 to move axially, it can carry a certain spiral rotation, and this rotation can well drive the multiple connecting arms 201 at the distal end and the multiple deformation units 11 connected to the connecting arms 201 to form a certain circumferential deflection, which is conducive to the formation of an interleaved form and the formation of a trend of rotating and converging into the sheath. In this way, it not only avoids the hard abutment and entering the sheath shown by B' in [figure], but also drives the distal end to rotate and deform to a certain extent, avoiding the abutment at the distal end. This method is easier to sheath and avoids breakage. In addition, it also reduces the strength of the pushing part 200 formed by cutting to a certain extent, making the distal end of the ablation device 1000 more flexible and easier to enter a preset position in the human body. Figure 1 the hard abutment and entering the sheath shown by B' in [figure], and it drives the distal end to rotate and deform to a certain extent, avoiding the abutment at the distal end. This method is easier to sheath and avoids breakage. In addition, it also reduces the strength of the pushing part 200 formed by cutting to a certain extent, making the distal end of the ablation device 1000 more flexible and easier to enter a preset position in the human body.

[0120] Further, as Figure 22 and Figure 23 shown, the ablation device 1000 further includes an outer sheath tube 400 sleeved outside the pushing part 200. The outer sheath tube 400 and the pushing part 200 can move axially relative to each other, so that the ablation member 100 located at the distal end of the pushing part 200 can be retracted / extended from the outer sheath tube 400. In other embodiments, the ablation member 100 is eccentrically arranged relative to the outer sheath tube 400, so that when the ablation member 100 is retracted into the outer sheath tube 400, the ablation member 100 can be unevenly squeezed in the circumferential direction. That is, the ablation member 100 and the outer sheath tube 400 are not coaxially arranged. As Figure 23 shown, the central axis of the ablation member 100 is X1, and the central axis of the outer sheath tube 400 is X2. The central axis X1 is eccentrically located on one side of the central axis X2. In this way, when the ablation member 100 is retracted into the outer sheath tube 400, due to the eccentric arrangement of the ablation member 100 relative to the outer sheath tube 400, the forces on the ablation member 100 from the outer sheath tube 400 in the circumferential direction are different, and there is a greater local force. Then the corresponding deformation unit 1111 is slightly inclined inward compared with other deformation units 11, which is more conducive to forming a dislocation, facilitating reducing circumferential abutment and entering the sheath in time.

[0121] The ablation device of the present invention connects a plurality of circumferentially spaced connecting arms to the ablation member. When the ablation member axially moves into the sheath, since the strength at the connection between the two is reduced, it is more convenient to insert into the sheath. At the same time, since each connecting arm is independent of each other, each of the circumferentially independent connecting arms has a certain amount of movement space in the circumferential direction. When the ablation member is radially constrained, the connecting arms connected to it can move in the circumferential direction, and this movement can further form a tendency of circumferential rotational insertion into the sheath, enabling the ablation member to be inserted into the sheath more easily and smoothly. In addition, the circumferential movement of the connecting arms is more conducive to driving the deformation unit at the distal end to move and form an interleaved shape, thereby further reducing the problem of continuous abutment at the distal end.

[0122] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in the specification of the present invention.

[0123] The above embodiments only represent several implementation manners of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent of the present invention should be subject to the appended claims.

Claims

1. An ablation device, characterized in that, It includes a pushing part and an ablation member connected to the distal end of the pushing part. The ablation member has a first state in which it unfolds into a funnel shape by itself when not restricted, and a second state in which it deforms and converges when radially restricted; the ablation member includes a support skeleton, and the support skeleton includes a plurality of deformation units on the distal side. The plurality of deformation units are circumferentially enclosed. The enclosed plurality of deformation units are adjacent to each other and can all deform independently relative to the adjacent deformation units; wherein, the pushing part includes a plurality of connecting arms provided at the distal end, the plurality of connecting arms are circumferentially spaced apart, and the free ends of the plurality of connecting arms are respectively connected to the proximal ends of the plurality of deformation units.

2. The ablation device according to claim 1, wherein, Each of the deformation units includes a first deformation part and a second deformation part connected in the circumferential direction. One of the first deformation parts of each deformation unit is adjacent to one of the second deformation parts of the adjacent deformation unit. The support skeleton further includes a plurality of main support rods. The plurality of main support rods are circumferentially spaced apart. The proximal end of each main support rod is connected to the free end of a connecting arm, and the distal end of each main support rod is simultaneously connected to the proximal ends of two adjacent first deformation parts and two adjacent second deformation parts in two adjacent deformation units.

3. The ablation device according to claim 2, characterized in that, There is a gap between the proximal sides of two adjacent first deformation parts and two adjacent second deformation parts in two adjacent deformation units, and the circumferential pitch of the gap gradually decreases from near to far along the extending direction.

4. The ablation device according to claim 3, wherein The main support rod is provided with a first through hole for the wire to pass through. The wire can sequentially pass through the first through hole and the gap. Among them, the wire between the gap and the first through hole is located outside the ablation member, and the rest is located inside. The length of the wire located outside is shorter than the length of the wire located inside.

5. The ablation device according to any one of claims 1 to 4, characterized in that The pushing part further includes a connecting part with a preset axial extension length. The proximal ends of the plurality of connecting arms are simultaneously connected to the distal end of the connecting part. A plurality of recessed parts are concavely provided on the outer surface of the connecting part, and the plurality of recessed parts are spaced apart along the axial direction and / or circumferential direction of the connecting part.

6. The ablation device according to claim 5, wherein The ablation device further includes a pushing tube and a sleeve. The distal end of the pushing tube is axially opposite to the proximal end of the pushing part. The sleeve is simultaneously sleeved on the pushing tube and the pushing part. The sleeve is relatively fixed to the pushing tube. The inner part of the sleeve extends into the recessed part to make the sleeve relatively fixed to the connecting part, so as to realize the relative fixation of the sleeve, the pushing tube and the pushing part.

7. The ablation device according to claim 6, wherein The connecting part of the pushing part is relatively fixed to the sleeve, and the plurality of connecting arms are placed in the sleeve and can move circumferentially in the sleeve.

8. The ablation device according to claim 5, wherein, The recessed part includes an arc-shaped notch formed around the circumference of the connecting part. The plurality of arc-shaped notches are spaced apart along the length direction of the connecting part, and the spaced-apart plurality of arc-shaped notches are arranged in a spiral shape on the outer circumference of the connecting part.

9. The ablation device according to claim 1, wherein, The ablation device further includes an outer sheath sleeved outside the pushing portion. The outer sheath and the pushing portion can move axially relative to each other, so that the ablation member located at the distal end of the pushing portion can be received / extended out of the outer sheath. Wherein, the ablation member is eccentrically arranged relative to the outer sheath, so that when the ablation member is received into the outer sheath, the ablation member can be unevenly squeezed in the circumferential direction.

10. The ablation device according to claim 1 or 9, characterized in that, The ablation device further includes a push tube. A first cavity and a second cavity are defined in the push tube. The second cavity is disposed substantially in a crescent shape and offset on the side of the first cavity.

Images