Ablation device
By optimizing the support framework structure of the ablation device and setting up deformation units with uneven support strength and deviation from the radial angle, the problem of the existing ablation device being easily broken during the sheathing process is solved, achieving smoother sheathing and reducing risks.
Patent Information
- Application Number
- PCT/CN2024/136715
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-26
- Filing Date
- 2024-12-04
- Publication Date
- 2025-07-03
AI Technical Summary
During the sheathing process, existing ablation devices are prone to bends at the front end of the support unit, making it difficult to retract and break, increasing operational difficulty and risk.
An ablation device is designed, and its ablation member includes a support frame, which consists of a plurality of deformation units. By defining that the structures of two adjacent deformation parts in the same group of units are the same or different, and setting uneven support strengths or deviated radial angles, breaking the support balance of a single deformation part, and optimizing the deformation unit structure to avoid the continuous top of the adjacent deformation part.
The external force required to collect the sheath is reduced, the risk of deformation part is reduced, and the operability and safety of the ablation device are improved.
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Figure CN2024136715_03072025_PF_FP_ABST
Abstract
Description
Ablation device 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 uses an ablation device to release ablation energy 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 shown in Figure 1. The electrode support unit 10' of the ablation device 100' needs to be retracted in the sheath. When the target position is reached, the electrode support unit 10' of the ablation device 100' needs to be released. After being unsheathed, the electrode support unit 10' of the ablation device 100' needs to completely restore its deformation 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 retracted into the outer sheath 400'. When the sheath is retracted, there are the following problems: 1. The front end bends of adjacent support units 10' (such as A' in Figure 1) are pressed against each other, which not only makes it difficult to retract the sheath, but also easily breaks, thereby increasing potential risks. 2. When the umbrella-shaped electrode support unit 10' initially enters the sheath, the proximal end of the support unit (i.e., B' in Figure 1) will form a hard abutment and extrusion with the outer sheath 400'. At this time, it is not only difficult to enter the sheath but also easy to cause damage at this point. 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-shaped structure. This also invisibly aggravates the problem of the phase top at the distal 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, characterized in that it comprises a pushing portion and an ablation component connected to the distal end of the pushing portion, the ablation component 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 comprises a support skeleton, the support skeleton comprises a plurality of deformation units located on the distal side, the plurality of deformation units are circumferentially enclosed, the plurality of enclosed deformation units are adjacent to each other and can deform independently relative to the deformation units adjacent thereto; each of the deformation units comprises a first deformation portion and a second deformation portion connected circumferentially, a first deformation portion of each deformation unit is adjacent to a second deformation portion of the deformation unit adjacent thereto; wherein,
[0009] The structures of the two adjacent first deformable portions and the second deformable portions in two adjacent deformable units are the same or different; when the structures of the two adjacent first deformable portions and the second deformable portions are the same, the supporting strengths of the first deformable portions and the second deformable portions are unevenly set; and / or,
[0010] The radial angles at which the distal ends of two adjacent first deformation portions and the second deformation portions of two adjacent deformation units deviate from each other are different.
[0011] In one embodiment, when the structures of two adjacent first deforming parts and second deforming parts are the same, the rod diameters of the first deforming parts and the rod diameters of the second deforming parts are unevenly set.
[0012] In one embodiment, the rod diameters of the distal ends of two adjacent first deformation parts and second deformation parts are smaller than the rod diameters of their respective proximal ends, so that the deformation capabilities of the distal ends of the first deformation part and the second deformation part are greater than the deformation capabilities of their respective proximal ends.
[0013] In one embodiment, the first deformable portion includes a first wall-adhering portion extending in the circumferential direction and a first support arm connected to the end of the first wall-adhering portion; the second deformable portion includes a second wall-adhering portion extending in the circumferential direction and a second support arm connected to the end of the second wall-adhering portion, and the first support arm and the second support arm both extend in the extension direction of the ablation member; wherein the rod diameters of the first wall-adhering portion and the second wall-adhering portion are respectively smaller than the maximum rod diameters of the first support arm and the second support arm.
[0014] In one embodiment, the first support arm includes a first section and a second section connected along its extension direction, and the distal end of the first section is connected to the end of the first wall portion; the second support arm includes a third section and a fourth section connected along its extension direction, and the distal end of the third section is connected to the end of the second wall portion; wherein the rod diameters of the first section and the third section are respectively smaller than the rod diameters of the second section and the fourth section.
[0015] In one embodiment, the rod diameter of the first wall-adhering portion is not greater than the rod diameter of the first section, and the rod diameter of the second wall-adhering portion is not greater than the rod diameter of the third section.
[0016] In one embodiment, the rod diameters of the second section and the fourth section gradually increase from far to near.
[0017] In one embodiment, the first wall-adhering portion is connected to the first support arm in an arcuate transition, and the second wall-adhering portion is connected to the second support arm in an arcuate transition.
[0018] In one embodiment, when the structures of two adjacent first deformable parts and second deformable parts are different, the support strength between the two adjacent first deformable parts and second deformable parts is set unevenly, so that the deformation capacity of the deformation part with smaller support strength is greater than the deformation capacity of the deformation part with larger support strength.
[0019] In one embodiment, the first deformable portion includes a first wall portion extending in a circumferential direction and a first support arm connected to the end of the first wall portion; the second deformable portion includes a second wall portion extending in a circumferential direction and a second support arm connected to the end of the second wall portion, and the first support arm and the second support arm both extend in the extension direction of the ablation member; wherein the rod diameter of the first support arm is different from the rod diameter of the second support arm.
[0020] In one embodiment, when the structures of two adjacent first deformation parts and second deformation parts are different, at least one of the adjacent first deformation parts and second deformation parts is provided with a guide structure and / or a guide member at the relative position between the two, so that when the ablation member is subject to radial constraint, the first deformation part and the second deformation part can produce radial displacement under the guiding action of the guide structure and / or guide member.
[0021] In one embodiment, the guide structure includes a first inclined surface obliquely provided on a side of the first deformable portion and a second inclined surface provided on a side of the second deformable portion and cooperating with the first inclined surface.
[0022] In one embodiment, when the radial angles of deviation of the distal ends of two adjacent first deformation portions and second deformation portions are different, the two adjacent first deformation portions and second deformation portions are radially offset, so that at least the distal sides of the two adjacent first deformation portions and second deformation portions do not deform on the same circumference at the same time.
[0023] In one embodiment, the distal side of the first deformable portion is tilted inward / outward relative to the second deformable portion, so that at least the distal sides of the first deformable portion and the second deformable portion do not deform simultaneously on the same circumference when the ablation member is radially constrained.
[0024] In one embodiment, the support skeleton also includes a plurality of main support rods, which are circumferentially spaced apart, and the proximal end of each main support rod is connected to the distal end of the pushing part, and the distal end of each main support rod is simultaneously connected to the proximal ends of two adjacent first deformation parts and second deformation parts.
[0025] In one embodiment, the diameter of the main support rod gradually decreases from far to near.
[0026] In one embodiment, a gap exists between the proximal ends of two adjacent first deformation portions and the proximal ends of the second deformation portions, and the circumferential spacing of the gap gradually decreases from proximal to distal along the extension direction.
[0027] In one embodiment, the main support rod is further provided with a first through-hole for a wire to pass through, and the wire can pass through the first through-hole and the gap in sequence, wherein the wire between the gap and the first through-hole is located on the outside of the ablation component, and the rest is located on the inside, and the length of the wire located on the outside is less than the length of the wire located on the inside.
[0028] In one embodiment, a plurality of free arms are provided at the distal end of the pushing portion, and the plurality of free arms are arranged at intervals around the circumference of the pushing portion, and the free ends of the plurality of free arms are respectively connected one by one to the proximal ends of the plurality of main support rods.
[0029] In one embodiment, the ablation component further includes a wire and an electrode, the electrode is provided on the support frame, and the wire is connected to the electrode.
[0030] In one embodiment, the electrode includes a first electrode and a second electrode respectively provided on two adjacent first deformable parts and the second deformable part, wherein the distance between the first electrode and the end of the first deformable part is different from the distance between the second electrode and the end of the second deformable part.
[0031] In one embodiment, the wire includes an exposed portion, which is located between the electrode and the support frame and at least partially adheres to the inner wall of the electrode.
[0032] In one embodiment, the ablation device further comprises an outer sheath tube which is sleeved outside the pushing portion, and the outer sheath tube and the pushing portion can move axially relative to each other so that the ablation component located at the distal end of the pushing portion can be retracted into / extended from the outer sheath tube; wherein, the ablation component is eccentrically arranged relative to the outer sheath tube so that when the ablation component is retracted into the outer sheath tube, the ablation component can be subjected to uneven squeezing in the circumferential direction.
[0033] In one embodiment, the pushing portion includes a pushing tube, a first cavity and a second cavity are defined in the pushing tube, and the second cavity is substantially crescent-shaped and offset to a side of the first cavity.
[0034] The ablation device of the present invention specifies whether the structures of two adjacent first and second deformable portions within the same unit are identical or different. When the structures of two adjacent first and second deformable portions are identical, to avoid the "pushing" problem encountered in the prior art, the support strengths of the first and second deformable portions within the same unit are set unevenly. This aims to disrupt the self-support balance of a single deformable portion, allowing local deformation to occur in addition to its own support. This prevents continuous "pushing" between the two deformable portions within the same unit through local deformation. When the structures are different, the support strengths of the two are altered by increasing the difference in support strength, causing one to deform preferentially, disrupting the relative balance and thus avoiding continuous circumferential friction. Furthermore, the distal ends of two adjacent first and second deformable portions 11a and 11b within the same unit are offset at different radial angles, i.e., the two adjacent deformable portions within the same unit are offset to prevent "pushing" when brought together.
[0035] The ablation device of the present invention optimizes and changes the structure of the deformable part in the deformable unit to weaken or eliminate the supporting force between the two deformable parts in the same group of units when they are subject to radial constraints, so that under the same force, compared with the prior art, at least one of the adjacent first deformable part and the second deformable part in the present invention is more likely to deform, and / or the two are more likely to be dislocated, thereby avoiding "pushing" together to cause damage through deformation and / or dislocation, reducing risks, and at the same time reducing the external force required for sheathing, thereby reducing the difficulty of sheathing.
[0036] The present invention provides an ablation device, comprising a pushing portion and an ablation component connected to the distal end of the pushing portion, the ablation component having 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 comprises a supporting skeleton, the supporting skeleton comprising a plurality of deformation units located on the distal end side, the plurality of deformation units being circumferentially enclosed, the enclosed plurality of deformation units being adjacent to each other and capable of independently deforming relative to the adjacent deformation units; the pushing portion comprises a plurality of connecting arms arranged at the distal end, the plurality of connecting arms being circumferentially spaced apart, and the free ends of the plurality of connecting arms being respectively connected to the proximal ends of the plurality of deformation units.
[0037] In one embodiment, each of the deformation units includes a first deformation portion and a second deformation portion connected in a circumferential direction, and a first deformation portion of each deformation unit is adjacent to a second deformation portion of an adjacent deformation unit;
[0038] The support skeleton also includes a plurality of main support rods, which 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 the second deformation parts in two adjacent deformation units.
[0039] In one embodiment, there is a gap between the proximal ends of two adjacent first deformable portions and the proximal ends of the second deformable portions in two adjacent deformable units, and the circumferential spacing of the gap gradually decreases from near to far along the extension direction.
[0040] In one embodiment, the main support rod is provided with a first through-hole for a wire to pass through, and the wire can pass through the first through-hole and the gap in sequence, wherein the wire between the gap and the first through-hole is located on the outside of the ablation component, and the rest is located on the inside, and the length of the wire located on the outside is less than the length of the wire located on the inside.
[0041] In one embodiment, the pushing portion also includes a connecting portion having a preset axial extension length, the proximal ends of multiple connecting arms are simultaneously connected to the distal end of the connecting portion, and multiple recessed portions are recessed on the outer surface of the connecting portion, and the multiple recessed portions are spaced apart along the axial direction and / or circumferential direction of the connecting portion.
[0042] In one embodiment, the ablation device further comprises a push tube and a cannula, wherein the distal end of the push tube is axially opposite to the proximal end of the push portion;
[0043] The sleeve is simultaneously sleeved on the pushing tube and the pushing portion, the sleeve and the pushing tube are relatively fixed, and the inner part of the sleeve extends into the recessed portion to relatively fix the sleeve and the connecting portion, thereby achieving relative fixation of the sleeve, the pushing tube and the pushing portion.
[0044] In one embodiment, the connecting portion of the pushing portion is fixed relative to the sleeve, and the plurality of connecting arms are placed in the sleeve and can move in the circumferential direction of the sleeve.
[0045] In one embodiment, the recessed portion includes an arc-shaped notch formed around the circumference of the connecting portion, and a plurality of the arc-shaped notches are spaced apart along the length direction of the connecting portion, and the plurality of spaced-apart arc-shaped notches are arranged in a spiral shape on the outer circumference of the connecting portion.
[0046] In one embodiment, the ablation device further comprises an outer sheath tube which is sleeved outside the pushing portion, and the outer sheath tube and the pushing portion can move axially relative to each other so that the ablation component located at the distal end of the pushing portion can be retracted into / extended from the outer sheath tube; wherein, the ablation component is eccentrically arranged relative to the outer sheath tube so that when the ablation component is retracted into the outer sheath tube, the ablation component can be subjected to uneven squeezing in the circumferential direction.
[0047] In one embodiment, the ablation device further includes a push tube, wherein a first cavity and a second cavity are defined in the push tube, and the second cavity is substantially crescent-shaped and offset to the side of the first cavity.
[0048] The ablation device of the present invention connects a plurality of circumferentially spaced connecting arms to the ablation component. When the ablation component moves axially into the sheath, the strength of the connection between the two is reduced, making it easier to insert the ablation component into the sheath. At the same time, since the connecting arms are independent of each other, the independent connecting arms spaced apart from each other have a certain amount of movement space in the circumferential direction. When the ablation component is subject to radial constraints, the connecting arm connected to it can move in the circumferential direction, and this movement can further form a trend of circumferential rotation into the sheath, so that the ablation component can be inserted into the sheath more easily and smoothly. In addition, the circumferential movement of the connecting arm is more conducive to driving the deformation unit at the distal end to move and form an interlaced shape, thereby further reducing the problem of continuous phase contact at the distal end. BRIEF DESCRIPTION OF THE DRAWINGS
[0049] FIG1 is a schematic structural diagram of a conventional ablation device;
[0050] FIG2 is a schematic structural diagram of an exemplary ablation device according to the present invention;
[0051] FIG3 is a perspective schematic diagram of a support frame of an exemplary ablation device of the present invention;
[0052] FIG4 is a schematic top view of a support frame of an exemplary ablation device of the present invention;
[0053] FIG5 is a schematic structural diagram of a deformation unit in an exemplary ablation device of the present invention;
[0054] FIG6 is a schematic structural diagram of two adjacent deformation units in an exemplary ablation device of the present invention;
[0055] FIG7 is a schematic structural diagram of a first deformable portion of a deformable unit and a second deformable portion of an adjacent deformable unit in an exemplary ablation device of the present invention, that is, a schematic structural diagram of the same group of units;
[0056] FIG8 is a schematic structural diagram of the first deformation portion in FIG7 ;
[0057] FIG9 is a schematic structural diagram of the second deformation portion in FIG7 ;
[0058] FIG10 is an enlarged schematic diagram of portion A in FIG7 ;
[0059] FIG11 is a schematic structural diagram of an exemplary ablation device according to the present invention in which the rod diameters of two adjacent first deformable portions and second deformable portions are unequal;
[0060] FIG12 is a schematic top view of the support frame in FIG11 ;
[0061] FIG13 is a schematic structural diagram of an exemplary ablation device according to the present invention in which the distal ends of two adjacent first deformable portions and second deformable portions deviate at different radial angles;
[0062] FIG14 is a schematic structural diagram of an exemplary ablation device according to the present invention in which electrodes on two adjacent first deformable portions and second deformable portions are arranged at non-equidistant intervals;
[0063] FIG15 is a schematic diagram of the outer peripheral side and the pushing portion of an exemplary ablation device of the present invention;
[0064] FIG16 is a schematic diagram of the arrangement of a guide wire of an exemplary ablation device of the present invention;
[0065] FIG17 is a schematic diagram of a partial structure of a main support rod of an exemplary ablation device of the present invention;
[0066] FIG18 is an enlarged schematic diagram of portion B in FIG15 ;
[0067] FIG19 is a schematic diagram of a partial structure of a main support rod of an exemplary ablation device of the present invention in which a guide wire groove is provided;
[0068] FIG20 is a partial schematic diagram of an exemplary ablation device according to the present invention, wherein electrodes are arranged on a support frame;
[0069] FIG21 is a schematic diagram of a partial structure of an exemplary ablation device according to the present invention, in which an electrode is disposed on a wall-attached portion of a deformation unit;
[0070] FIG22 is a schematic diagram of a partial structure of an exemplary ablation device according to the present invention, including a push tube and an outer sheath tube;
[0071] FIG23 is a schematic diagram of a partial structure of an exemplary ablation device according to the present invention, in which the ablation member is placed outside the distal end of the outer sheath;
[0072] FIG24 is a schematic structural diagram of an exemplary ablation device including a cooling assembly according to the present invention;
[0073] FIG25 is a cross-sectional view of a cooling assembly and a guide wire of an exemplary ablation device according to the present invention passing through a push tube;
[0074] FIG26 is an enlarged schematic diagram of portion C in FIG22 , which is a schematic structural diagram of an exemplary ablation device according to the present invention;
[0075] FIG27 is a schematic diagram showing a spiral-shaped recessed portion on a pushing portion of an exemplary ablation device according to the present invention;
[0076] FIG28 is a schematic structural diagram of the push portion, push tube, and sleeve of an exemplary ablation device of the present invention. DETAILED DESCRIPTION
[0077] In order to make the objectives, technical solutions, and advantages of the present invention more clearly understood, exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.
[0078] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, 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 specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.
[0079] Although the terms first, second, third, etc. can be used in the text 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 can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.
[0080] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative 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 "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.
[0081] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or of a delivery device used to deliver the medical device, that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device or delivery device. "Axial" generally refers to the length of the medical device during delivery, while "radial" generally refers to the direction perpendicular to the "axial" direction of the medical device. This principle is used to define the "axial" and "radial" directions of any component of a medical device.
[0082] Refer to Figure 1, which is a schematic diagram of an ablation device previously proposed by the applicant. Combined with the accompanying drawings and relevant published literature, it can be seen that the ablation device 100' can adapt well to the target tissue morphology and achieve good fit with the target tissue. However, for this ablation device 100', the applicant found during the operation and experiment 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. This leads to the phenomenon that when the electrode support unit 10' is sheathed, the front end bending parts of adjacent support units 10' (such as A' in Figure 1) are pushed together. This not only requires a large force to sheath, but also easily breaks at the same point. This undoubtedly increases the difficulty and potential risks of the sheathing operation. Based on this, the applicant further proposed an optimized solution on this basis to at least solve the problem of easy breakage caused by "pushing" together.
[0083] In view of this, referring to FIG2 , the present invention exemplarily provides an ablation device 1000, which includes an ablation member 100 and a push portion 200, wherein the proximal end of the ablation member 100 is connected to the distal end of the push portion 200. The ablation member 100 has a first state in which it self-expands into a funnel shape when unconstrained, and a second state in which it deforms and gathers when subjected to radial constraints. The ablation member 100 of the present invention can reach a preset position and self-expand as the push portion 200 moves axially, and can deform and gather into a second state in which it is contracted based on the radial constraint force applied to it as the push portion 200 moves axially. FIG2 shows the ablation member 100 in the first state in which it self-expands into a funnel shape when unconstrained. It should be noted that the funnel shape defined in the present invention is only a rough description of the unfolded form of the ablation component 100, and does not mean that the inner surface or outer surface after unfolding must be on the same circumferential surface. The same circumferential surface or different circumferential surfaces are acceptable. For example, they can all be on the same circumferential surface, or they can be staggered front to back, or they can be wrapped front to back in sequence like petals, etc.
[0084] Continuing with reference to FIG2 , the ablation component 100 includes a support frame 10, which has a first state in which it self-expands into a funnel shape when unconstrained, and a second state in which it deforms and gathers when radially constrained. The explanation of the funnel shape is as described above. In addition, in other embodiments, the ablation component 100 further includes a wire 30 and an electrode 20, wherein the electrode 20 is disposed on the support frame 10, and the wire 30 extends from the proximal end toward the distal end and is connected (electrically connected) to the electrode 20 on the support frame 10. Exemplarily, the support frame 10 and the pushing portion 200 are formed integrally, for example, by cutting and shaping, but this is of course not limited to this.
[0085] 2 to 7 , the support skeleton 10 includes a plurality of deformation units 11 located at the distal end. The plurality of deformation units 11 are circumferentially enclosed. The circumferential enclosure does not necessarily mean that they are opposite to each other and located on the same circumferential surface. It includes adjacent and opposite locations on the same circumferential surface. It can also be formed by radial front-to-back staggering, or circumferential front-to-back staggering. As shown in FIG3 and FIG4 , the plurality of deformation units 11 are located between the two rings Z1 and Z2 and circumferentially enclosed in this area. The structure in an S1 area between the two rings Z1 and Z2 is a deformation unit 11, and two adjacent S1 areas form an S2 area, that is, the structure in an S2 area is two adjacent deformation units 11. The enclosed plurality of deformation units 11 are adjacent to each other and can deform independently relative to the adjacent deformation units 11, that is, the two adjacent deformation units 11 in the S2 area can deform independently relative to each other. As shown in Figure 5, a deformable unit 11 located in region S1 includes a first deformable portion 11a and a second deformable portion 11b connected circumferentially. As shown in Figure 6, two adjacent deformable units 11 in region S2, wherein the first deformable portion 11a of one deformable unit 11 is adjacent to the second deformable portion 11b of the adjacent deformable unit 11, and the first deformable portion 11a of one deformable unit 11 is adjacent to the second deformable portion 11b of the adjacent deformable unit 11, form a group of the same unit, namely, region S3 in Figure 7. It should be noted that the dashed lines in the drawings of the present invention are merely added lines to clearly illustrate the multi-unit structure of the present invention and do not constitute the structure of the ablation device itself.
[0086] To address the above-mentioned issues, the present invention proposes to limit the structures of two adjacent first deformable portions 11a and second deformable portions 11b in the same group of units to be identical or different. When the structures of two adjacent first deformable portions 11a and second deformable portions 11b are identical, in order to avoid the "pushing" problem in the prior art, the support strengths of the first deformable portions 11a and second deformable portions 11b in the same group of units are set unevenly, aiming to disrupt the self-support balance of a single deformable portion and to construct local deformation in addition to its own support, thereby avoiding continuous "pushing" by the local deformation of the two deformable portions in the same group. And / or, the present invention also proposes another solution in which the radial angles of the distal ends of two adjacent first deformable portions 11a and second deformable portions 11b in the same group of units are limited to be different, that is, the two adjacent deformable portions in the same group of units are offset to avoid "pushing" when gathered.
[0087] The present invention aims to optimize and modify the structure of the deformable portions within a deformable unit to at least weaken or eliminate the supporting force exerted on each other by two deformable portions within the same unit group when subjected to radial constraints. This results in at least one of the adjacent first and second deformable portions being more easily deformed and / or more easily misaligned than in the prior art under the same applied force. This deformation and / or misalignment prevents damage caused by "pushing together" and reduces risk. Furthermore, the external force required for sheathing is reduced, making sheathing easier. It is understood that the innovative nature of the present invention lies in at least a localized improvement, compared to the prior art solution, where multiple deformable units are circumferentially enclosed, forming a circumferential circle of "pushing" against each other during sheathing. For example, the present invention optimizes at least one group of adjacent deformable portions to relieve the circumferential supporting force through at least one group. Of course, optimization can be applied to multiple or all groups to improve the effect. This optimization can be selectively configured based on actual needs and is not a limitation. The term "deformation" in the present invention refers to the degree of change in shape under the same force. The term "adjacent" in the present invention refers only to a relative positional relationship, that is, adjacent but not connected at the opposite locations.
[0088] As shown in Figures 6 to 10 , the first deformable portion 11a includes a first circumferentially extending abutment portion a1 and a first support arm a2 connected to the distal end of the first abutment portion a1. The second deformable portion 11b includes a second circumferentially extending abutment portion b1 and a second support arm b2 connected to the distal end of the second abutment portion b1. Both the first support arm a2 and the second support arm b2 extend in the direction of extension of the ablation member 100. Preferably, to avoid stress concentration and form a transitional compliant deformation, the first abutment portion a1 and the first support arm a2 are connected in an arcuate transition, and the second abutment portion b1 and the second support arm b2 are connected in an arcuate transition. In other embodiments, as shown in Figures 8 to 10 , the first support arm a2 includes a first segment a21 and a second segment a22 connected along its extension direction, with the distal end of the first segment a21 connected to the distal end of the first abutment portion a1. The second support arm b2 includes a third segment b21 and a fourth segment b22 connected along its extension direction, with the distal end of the third segment b21 connected to the distal end of the second abutment portion b1.
[0089] The present invention's solution for optimizing the two deformation parts in the same group of units will be described below with reference to examples in conjunction with the accompanying drawings. It should be noted that among the following multiple solutions, when the structures do not conflict, they can be selectively combined to solve the technical problems mentioned in this application.
[0090] Example 1
[0091] In this embodiment 1, the structures of two adjacent first deformable portions 11 a and second deformable portions 11 b are the same or different, that is, the structures of two adjacent deformable portions in the same unit group are the same or different.
[0092] Example 1.1
[0093] The structures of the two adjacent first deformable portions 11 a and the second deformable portions 11 b in the embodiment 1.1 are the same, that is, the structures of the two adjacent deformable portions in the same unit group are the same.
[0094] In this embodiment, the structures of the two adjacent first deformation parts 11a and the second deformation parts 11b are the same. In this case, if the two adjacent deformation parts are adjacent and opposite to each other, the support strength of each of them needs to be set unevenly, in order to break the self-support balance of a single deformation part, and to construct local deformation in addition to its own support. The local deformation of the two deformation parts in the same group can avoid continuous "pushing". That is, deformation and dislocation are achieved through the internal imbalance of each part.
[0095] As an embodiment of unevenly setting the support strength of the first deformable portion 11a and the second deformable portion 11b, holes can be punched in the first deformable portion 11a and the second deformable portion 11b to change the unevenness of their support strength. For example, by punching holes in the distal ends of the two deformable portions, the support strength of the distal ends is reduced, while the support strength of the proximal ends remains unchanged. This disrupts the original self-support balance of the single deformable portion, and while ensuring its own proximal support, it also creates localized deformation on the distal end. When the ablation member 100 is radially constrained, the distal ends of the two deformable portions, supported by their respective proximal ends, preferentially deform and dislocate, thereby reducing the circumferential abutment force. Of course, for example, the density of holes punched in the distal ends of the two deformable portions can be increased, resulting in a greater reduction in support strength, while the density of holes punched in the proximal ends can be decreased, resulting in a lesser reduction in support strength. This can achieve the goal of preferentially deforming and dislocating the distal ends when constrained.
[0096] As another embodiment of unevenly setting the support strength of the first deformable portion 11a and the second deformable portion 11b, this can be achieved by improving the rod diameters of two adjacent deformable portions in the same family of units, so that the rod diameters of the first deformable portion 11a and the second deformable portion 11b are unevenly set, thereby breaking the original self-support balance of the single deformable portion. For example, as shown in Figures 3 to 10, the rod diameters of the distal ends of the two adjacent first deformable portions 11a and second deformable portions 11b can be made smaller than the rod diameters of their respective proximal ends, so that the deformation capacity of the distal ends of the first deformable portion 11a and second deformable portion 11b is greater than the deformation capacity of their respective proximal ends. When the ablation member 100 is radially constrained, the distal ends of the two deformable portions, supported by their respective proximal ends, preferentially deform and dislocate, thereby reducing the continuous circumferential offset.
[0097] As shown in Figure 10 , the first deformable portion 11a specifically comprises a circumferentially extending first abutment portion a1 and a first support arm a2 connected to the distal end of the first abutment portion a1. The second deformable portion 11b comprises a circumferentially extending second abutment portion b1 and a second support arm b2 connected to the distal end of the second abutment portion b1. The diameters of both the first abutment portion a1 and the second abutment portion b1 are smaller than the maximum diameters of the first and second support arms a2 and b2, respectively. This reduces the support strength of the abutment portions and makes them relatively more susceptible to deformation. When the ablation element 100 is radially constrained, the distal abutment portions, supported by their respective support arms, preferentially deform and misalign, thereby reducing the circumferential friction between the two abutment portions.
[0098] To further prevent the deformable portion from breaking due to a large difference in strength at the point of change due to uneven support strength, the first support arm a2 includes a first section a21 and a second section a22 connected along its extension direction, and the second support arm b2 includes a third section b21 and a fourth section b22 connected along its extension 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, thereby forming a transitional change in support and a deformation that conforms to the transition. At this point, the support strength of the first section a21 and the third section b21 is weakened, and the point where the first section a21 and the third section b21 abut against each other is also more susceptible to deformation. This allows the first section a21 and the first wall-adhering portion a1, and the third section b21 and the second wall-adhering portion b1 to deform more effectively, thereby providing stronger support on the proximal side of the support arm. The other end of the support arm forms a transition with the wall-adhering portion, preventing breakage at the point where the two are connected.
[0099] The diameter of the first wall-adhering portion a1 is no greater than the diameter of the first section a21, and the diameter of the second wall-adhering portion b1 is no greater than the diameter of the third section b21. Preferably, to prevent bending deformation at the connection between the first wall-adhering portion a1 and the connected first section a21, and the second wall-adhering portion b1 and the connected third section b21 due to large differences in support strength, the diameter of the first wall-adhering portion a1 is approximately equal to the diameter of the first section a21, and the diameter of the second wall-adhering portion b1 is approximately equal to the diameter of the third section b21, to ensure structural compliance and form transitional deformation. In a further optimized embodiment, to provide effective support at the proximal end and a transition in support strength, the diameters of the second section a22 and the fourth section b22 gradually increase from distal to proximal. This design also facilitates sheath retraction.
[0100] This embodiment shows that when two adjacent first deformable portions 11a and second deformable portions 11b within the same group have the same structure, the support strength of the first and second deformable portions 11a, 11b within the same group is unevenly set. This disrupts the self-support balance of a single deformable portion, allowing local deformation to occur in addition to its own support. This prevents continuous "pushing" by preferentially deforming the two deformable portions within the same group. Compared to the prior art, under the same conditions, the first and second deformable portions 11a, 11b of this embodiment each deform locally preferentially, thereby reducing their mutual resistance.
[0101] Example 1.2
[0102] In this embodiment 1.2, the structures of the two adjacent first deformable portions 11 a and the second deformable portions 11 b are different, that is, the structures of the two adjacent deformable portions in the same unit group are different.
[0103] Example 1.2.1
[0104] In this embodiment, the structures of two adjacent first deformable portions 11a and second deformable portions 11b differ. The support strength between the two adjacent first deformable portions 11a and second deformable portions 11b is uneven, resulting in the deformation capacity of the deformable portion with lower support strength being greater than that of the deformable portion with higher support strength. This approach aims to disrupt the support balance between the two adjacent deformable portions by creating a support strength difference, thereby causing one to deform first and prevent continuous "crushing" of the other.
[0105] As shown in Figures 11 and 12 , as an embodiment of uneven support strength between two adjacent first and second deformable portions 11a and 11b, the first deformable portion 11a includes a circumferentially extending first wall portion a1 and a first support arm a2 connected to the end of the first wall portion a1; the second deformable portion 11b includes a circumferentially extending second wall portion b1 and a second support arm b2 connected to the end of the second wall portion b1. The first support arm a2 has a different diameter than the second support arm b2. This difference in diameter (for example, the first support arm a2 has a smaller diameter than the second support arm b2) results in different support strengths between the first and second deformable portions 11a and 11b within the same unit, resulting in different degrees of deformation. When the ablation element 100 is subjected to radial constraint, the portion with less support strength deforms first, causing the two portions to be offset, thereby reducing the continuous circumferential offset. The portion with greater support strength also deforms as the radial constraint increases.
[0106] As shown in this embodiment, 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 support strength between 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.
[0107] Example 1.2.2
[0108] In this embodiment, the structures of the two adjacent first deformation portions 11a and the second deformation portions 11b 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 component 100 is subject to radial constraint, 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.
[0109] As an exemplary embodiment, the guide structure includes a first inclined surface disposed obliquely on the side of the first deformable portion 11a, and a second inclined surface disposed on the side of the second deformable portion 11b that cooperates with the first inclined surface. When the ablation member 100 is radially constrained, the first deformable portion 11a and the second deformable portion 11b deform and misalign under the radial constraint, thereby reducing the circumferential abutment force.
[0110] In this embodiment, by changing the structures of the opposite sides of two adjacent first deformable portions 11a and second deformable portions 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.
[0111] Example 2
[0112] In this embodiment 2, the distal ends of two adjacent first deformable portions 11 a and second deformable portions 11 b deviate at different radial angles, that is, the distal ends of two deformable portions in the same unit group deviate at different radial angles.
[0113] In this embodiment, when the distal ends of two adjacent first deformable portions 11a and second deformable portions 11b deviate at different radial angles, the two adjacent first deformable portions 11a and second deformable portions 11b are radially offset relative to each other. In this case, the distal ends of the first deformable portions 11a and second deformable portions 11b in the same unit group are adjacent to each other but not circumferentially opposed. This allows the distal ends of the two adjacent first deformable portions 11a and second deformable portions 11b to be radially constrained, with their distal ends offset front-to-back and not deforming simultaneously on the same circumference, thereby eliminating the state where the distal ends are lowered. In this second embodiment, since the front-to-back offset eliminates the circumferentially abutting state, the structures of the two adjacent first deformable portions 11a and second deformable portions 11b in this embodiment can be the same or different, and their support strengths can be the same or different.
[0114] As shown in Figure 13, as an embodiment, the distal side of the first deformable portion 11a is tilted inward / outward relative to the second deformable portion 11b, so that when the ablation component 100 is subject to radial constraints, at least the distal sides of the first deformable portion 11a and the second deformable portion 11b are misaligned inward and outward and do not deform on the same circumference at the same time, thereby eliminating the distal circumferential abutment force of the two when the ablation component 100 is subject to radial constraints and avoiding the "phase-to-phase" problem.
[0115] Example 3
[0116] The structures of two adjacent first deformable portions 11 a and second deformable portions 11 b in this embodiment 3 are the same or different, that is, the structures of two adjacent deformable portions in the same unit group are the same or different.
[0117] As shown in Figure 14 , this embodiment is an optimization based on the ablation component 100 including the electrode 20. As previously mentioned, the ablation component 100 also includes a wire 30 and the electrode 20. The electrode 20 is disposed on the support frame 10. The wire 30 extends from the proximal end to the distal end and is connected to the electrode 20 disposed on the support frame.
[0118] As shown in Figure 14, the electrode 20 includes a first electrode 20a and a second electrode 20b respectively arranged on two adjacent first deformation parts 11a and second deformation parts 11b. The first electrode 20a is arranged on the first wall part a1, and the second electrode 20b is arranged on the second wall part b1. The distance between the first electrode 20a and the end of the first deformation part 11a is different from the distance between the second electrode 20b and the end of the second deformation part 11b. The end here refers to the end of the two adjacent deformation parts in the relative circumferential direction. As shown in Figure 14, 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-attached 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-attached part b2. As shown in the partial enlarged view in Figure 14, the distance on the left is longer and the distance on the right is shorter. This method adjusts the support strength of the two adjacent deformation parts by the distance between the electrode settings, so that a difference in the support strength of the two is formed, so that one of them is deformed and dislocated faster under the same force, thereby reducing the circumferential abutment force.
[0119] The solutions shown in the above embodiments all solve the problem of easy breakage caused by "pushing" together in existing ablation devices. As mentioned above, the above embodiments are all illustrative descriptions of solving the problem. In the case of no structural conflict, multiple embodiments can be selectively combined to obtain a new combination solution to this problem. The following will be based on any of the above embodiments to elaborate on other components of the ablation device of the present invention in detail, with the purpose of illustrative description or further optimization. Among them, the rod diameter of the present invention refers to the diameter when it is a cylindrical structure, and refers to the circumferential width when it is a flat shape after cutting. It should be understood that it is not limited to this and can also be the common knowledge of those skilled in the art.
[0120] As shown in the prior art in FIG1 , the proximal end of the support arm of each deformation unit in the ablation device can be directly connected to the distal end of the pushing portion. As shown in FIG2 , FIG3 and FIG15 to FIG19 , in other embodiments of the present invention, in order to facilitate convergence and orderliness during convergence while forming effective support, the support skeleton 10 also includes a plurality of main support rods 12, and the plurality of main support rods 12 are arranged at intervals in the circumference. The proximal end of each main support rod 12 is connected to the distal end of the pushing portion 200, and the distal end of each main support rod 12 is simultaneously connected to the proximal ends of the two adjacent first deformation portions 11a and the second deformation portion 11b. When the deformation portion includes a wall-attached portion and a support arm, the distal end of each main support rod 12 is simultaneously connected to the proximal ends of the two adjacent support arms. In which, when the first deformation portion 11a includes a first wall-adhering portion a1 extending in the circumferential direction and a first support arm a2 connected to the end of the first wall-adhering portion a1, and the second deformation portion 11b includes a second wall-adhering portion b1 extending in the circumferential direction and a second support arm b2 connected to the end of the second wall-adhering portion 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.
[0121] Referring to 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 becomes thinner from far to near, which has a certain guiding effect and is conducive to staggering. At the same time, it is wider at the distal end connected to the support arm, which can form a strong support and increase the radial force. As shown in Figure 17, when the first support arm a2 includes a first section a21 and a second section a22 connected along its extension direction, and the second support arm b2 includes a third section b21 and a fourth section b22 connected along its extension 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 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, and the rod 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 width of the connection between the two is the same. This setting, for the main support rod 12, becomes thinner toward the proximal side, forming a certain guiding effect, facilitating sheathing, facilitating interlacing, and increasing radial force; for the support arm, a transition of support strength is formed toward the distal side, facilitating compliant deformation; at the same time, a strong support strength is formed at the widest connection between the two, facilitating deployment.
[0122] Continuing with Figures 15 to 18 , in other embodiments, a gap 11c exists between the proximal ends of two adjacent first deformable portions 11a and second deformable portions 11b. This gap 11c, on the one hand, provides space for the first deformable portion 11a and the second deformable portion 11b to misalign when the ablation member 100 is radially constrained. On the other hand, this gap 11c allows the guidewire 30 to pass through, allowing at least a portion of the guidewire 30 to be positioned inside the ablation member 100, thereby preventing abrasion of the external sheath on the externally located guidewire 30.
[0123] Furthermore, in other embodiments, as shown in Figures 17 and 18 , the circumferential spacing of the gap 11c of the present invention gradually decreases from proximal to distal, resulting in the gap 11c being roughly elongated and teardrop-shaped. This arrangement of gap 11c results in a larger spacing between the first support arm a2 and the second support arm b2 at the proximal end, while decreasing at the distal end, and even forming a contact state at the distal end. This arrangement serves the following purposes: first, it ensures a larger misalignment space between the first support arm a2 and the second support arm b2 at the proximal end, facilitating folding and retraction into the sheath when subjected to radial constraints, thereby minimizing the outer diameter; second, it allows the first support arm a2 and the second support arm b2 to form circumferential contact or near contact at the distal end, facilitating rapid interaction and deformation and misalignment when subjected to radial constraints. This also maximizes the circumference of the wall-adhering portion of the ablation member 100, facilitating ablation. Third, when the wire 30 passes through the gap 11c, the larger space at the proximal end provides space for the wire 30 to pass through. Furthermore, since the wire 30 continues to extend after passing through the gap 11c and connects with the electrode 20 on the wall-attached portion, it will need to move as the ablation member 100 converges and expands. This gradually decreasing circumferential spacing from the proximal end to the distal end prevents the wire 30 from rigidly contacting the support frame 10 at the gap. As the wall-attached portion drives the electrode 20 toward the distal end, the wire 30 extends distally through the through-hole in the gap 11c, allowing the wire 30 within the gap 11c to follow the electrode 20 in the distal direction. This allows the wire 30 to adapt to the displacement of the electrode 20 in the direction of movement after the wall-attached portion closes. This allows the wire 30 to move more smoothly even after passing through the larger space at the proximal end and abutting against the inner / outer walls of the ablation member 100. Furthermore, the teardrop-shaped gap 11c also serves as a guide to a certain extent.
[0124] Continuing with Figures 15 to 18 , in other embodiments, the main support rod 12 further comprises a first through-hole 121 through which the wire 30 can pass. The wire 30 can sequentially pass through the first through-hole 121 and the gap 11c. The support frame 10 comprises a gap 11c and the first through-hole 121, with the gap 11c and the first through-hole 121 spaced apart. The gap 11c is located proximal to the support arm, and the first through-hole 121 is located proximal to the gap 11c. The wire 30 passes through the first perforation 121 and the gap 11c in sequence and is connected to the electrode 20. For example, in one embodiment, the wire 30 passes through the radial inner side of the pushing portion 200, the wire 30 adheres to the inner wall of the support skeleton 10 and extends toward the distal end of the ablation component 100, the wire 30 passes through the first perforation 121 from the inner wall of the support skeleton 10, and then extends from the radial outer side of the support skeleton 10 toward the gap 11c and passes through the gap 11c to enter the radial inner side of the support skeleton 10, and then bends toward the wall-adhering portion to connect with the electrode 20.
[0125] In this way, by opening the gap 11c and the first perforation 121 on the support frame 10, after the wire 30 passes through the gap 11c and the first perforation 121, the gap 11c and the first perforation 121 can limit the wire 30, and then the gap 11c is located on the proximal side of the support arm, and the gap 11c is set close to the support arm, so that the wire 30 can bend toward the wall-adhering part after passing through the gap 11c, reducing the possibility of the wire 30 being sandwiched between the two support arms during the process of being received into the outer sheath 400 or released from the outer sheath 400, thereby avoiding the wire 30 from being damaged by the interlaced friction of the support arms, causing the insulation layer of the wire 30 to be damaged.
[0126] Preferably, the wire 30 between the gap 11c and the first perforation 121 is located on the outside of the ablation component 100, and the rest is located on the inside, and the length of the wire 30 located on the outside is less than the length of the wire 30 located on the inside. Exemplarily, the spacing distance between the gap 11c and the first perforation 121 is defined as <0.5mm. It should be noted that there is a certain spacing distance between the gap 11c and the first perforation 121, and the spacing distance is used to provide a bending space for the wire 30 to thread the wire. However, the spacing distance between the gap 11c and the first perforation 121 cannot be too large. When the spacing distance between the gap 11c and the first perforation 121 is too large, it is easy to cause the wire 30 to form a floating wire between the gap 11c and the first perforation 121 during the sheathing process, which increases the probability that the insulation layer of the wire 30 is damaged by friction with the sheath. Therefore, by setting the spacing distance between the gap 11c and the first through-hole 121 to be less than 0.5 mm, a certain threading and bending space can be provided for the wire 30 while preventing the distance between the gap 11c and the first through-hole 121 from being too large to cause the wire 30 to float.
[0127] As shown in Figure 18, a second through-hole 200a is provided on the distal end of the pushing portion 200, and the second through-hole 200a is located on the proximal side of the first through-hole 121. The wire 30 passes through the second through-hole 200a, the first through-hole 121 and the gap 11c in sequence to connect with the electrode 20. As shown in Figures 2 and 15, the pushing portion 200 includes a connecting portion 202, and the second through-hole 200a can be provided at the distal end of the connecting portion 202. In other embodiments, the pushing portion 200 of the present invention also includes a connecting arm 201 located at the distal end, and a plurality of connecting arms are arranged circumferentially spaced around the connecting portion 202, and the free ends of the plurality of connecting arms 201 are respectively connected one by one to the proximal ends of the plurality of main support rods 12. When a connecting arm is provided at the distal end of the pushing portion 200, the second through-hole 200a can be provided on the connecting arm 201 located at the distal end of the connecting portion 202. The multiple connecting arms 201 are relatively independent of each other, and adjacent connecting arms 201 can move relative to each other, which is conducive to driving the edge movement of the distal deformation unit, facilitating the formation of a staggered shape, and also facilitating sheathing.
[0128] In this embodiment, the guidewire 30 enters the support frame 10 from the radially outer side of the support frame 10 through the second through-hole 200a. The guidewire 30 extends distally along the inner wall of the support frame 10, passes through the first through-hole 121, exits the radially outer side of the support frame 10, and then enters the support frame 10 from the radially outer side of the support frame 10 through the gap 11c. Thus, by providing the second through-hole 200a at the distal end of the pushing portion 200, the second through-hole 200a and the first through-hole 121 cooperate to confine the guidewire 30 to the radially inner sidewall of the support frame 10, thereby allowing the majority of the guidewire 30 to rest against the inner wall of the support frame 10. This prevents the guidewires 30 from intertwining with each other during sheath retraction, which could hinder deployment of the ablation element 10. Furthermore, it prevents the guidewires 30 from being scraped by the sheath and damaging the insulation layer of the guidewires 30.
[0129] As shown in FIG19 , in other embodiments, the inner wall of the main support rod 12 may further be provided with a wire groove 122 extending from the proximal end of the main support rod 12 to the first through-hole 121. The wire 30 is at least partially accommodated within the wire groove 122. The wire 30 passes through the second through-hole 200a into 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 within the wire groove 122, reducing the loading volume of the ablation element 100.
[0130] As shown in FIG. 20 , in other embodiments, the wire 30 of this embodiment includes an exposed portion 31 . The exposed portion 31 is located between the electrode 20 and the support frame 10 and at least partially adheres to the inner wall of the electrode 20 .
[0131] As shown in Figures 20 and 21, 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 portion 32, and the exposed portion 31 and the main portion 32 are connected. The exposed portion 31 refers to the portion where the insulating layer 30b is not provided so that the conductive layer 30a is exposed. The exposed portion 31 is located between the electrode 20 and the wall-attached portion of the support frame 10, and the exposed portion 31 is in contact with the inner wall of the electrode 20. The main portion 32 refers to the portion where the insulating layer 30b is provided on the outside of the conductive layer 30a. One end of the wire 30 is electrically connected to an external power supply. The conductive layer 30a can be made of one or more materials such as copper, aluminum, silver or gold. The inner wall of the electrode 20 can be fully or partially in contact with the exposed portion 31.
[0132] During operation of ablation device 100, a power source delivers current to wire 30, which then flows through exposed portion 31 and into electrode 20. When energized, electrode 20 forms an ablation field, achieving ablation of the target area. After ablation is complete, the power source is disconnected from wire 30, causing electrode 20 to cease emitting the ablation field and, consequently, stopping ablation.
[0133] In this way, the electrode 20 is arranged on the wall-attached part of the support frame 10, so that the support frame 10 can press the electrode 20 against the tissue to be ablated, and then the wire 30 includes an exposed part 31, and the exposed part 31 is located between the electrode 20 and the support frame 10, so that the exposed part 31 is at least partially 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 method in the prior art where only one end or both ends of the electrode 20 are connected to the wire 30, the conductive area of the electrode 20 and the wire 30 is increased, which facilitates the transfer of current and increases the heating rate of the electrode 20, thereby reducing the ablation time and reducing the patient's pain.
[0134] 22 , ablation device 1000 further includes an outer sheath 400 disposed over the pusher portion 200. The outer sheath 400 and the pusher portion 200 are axially movable relative to each other, allowing the ablation member 100, located at the distal end of the pusher portion 200, to be retracted into or extended from the outer sheath 400. In other embodiments, the ablation member 100 is eccentrically disposed relative to the outer sheath 400, i.e., the ablation member 100 and the outer sheath 400 are non-coaxially disposed. As shown in Figure 23, the central axis of the ablation component 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 component 100 is received into the outer sheath tube 400, since the ablation component 100 is eccentrically arranged relative to the outer sheath tube 400, the ablation component 100 is subjected to different forces from the outer sheath tube 400 in the circumferential direction, and there is a local greater force. The corresponding deformation unit 11 is slightly tilted inward compared to other deformation units, which is more conducive to forming dislocation, facilitating the reduction of circumferential abutment, and timely insertion of the sheath.
[0135] As shown in FIG22 , in order to operate the push portion 200 at the proximal end, the exemplary ablation device 1000 of the present invention further includes a push tube 300. The distal end of the push tube 300 is connected to the proximal end of the push portion 200, and the proximal end of the push tube 300 is provided for operator operation. Exemplarily, as shown in FIG22 and FIG25 , a first cavity 300a and a second cavity 300b are defined within the push tube 300. In other embodiments, the second cavity 300b is substantially crescent-shaped and offset to the side of the first cavity 300a. The first cavity 300a can be used to pass a cooling liquid, and the second cavity 300b can be used to pass a guide wire 30. The guide wire 30 is disposed within the second cavity 300b and at least partially exits the distal end of the push tube 300. 22 and 25 , the first cavity 300a of the present invention has a generally circular cross-section, while the second cavity 300b has a generally crescent-shaped cross-section. The second cavity 300b is offset to the side of the first cavity 300a, resulting in a flattened push tube 300 with a cross-section that generally includes two opposing arcs and a plane connecting the two opposing arcs. This arrangement not only achieves a dual-lumen design but also facilitates minimizing the radial dimension of the push tube 300, thereby minimizing the overall outer diameter of the entire ablation device. More importantly, when connected to the ablation member 100 at its distal end, it facilitates eccentric placement of the ablation member 100 relative to the outer sheath 400. For example, when the push portion 200 includes a connecting portion 202, the connecting portion 202 is a tubular structure, the lumen of which is in communication with both the first cavity 300a and the second cavity 300b of the push tube 300.
[0136] Referring to Figures 24 and 25, the ablation device 1000 also includes a cooling component 500, which is located on the radial inner side of the support frame 10. A first cavity 300a and a second cavity 300b are opened in the push tube 300. The first cavity 300a and the second cavity 300b are arranged along the axial direction of the push tube 300. The wire 30 is passed through the second cavity 300b, and the first cavity 300a is connected to the cooling component 500.
[0137] The cooling assembly 500 includes a cooling balloon 501 and a delivery pipe 502. The distal end of the cooling balloon 501 is closed, and the proximal end of the cooling balloon 501 is connected to and communicates with the delivery pipe 502. The cooling balloon 501 is located radially inward of the support frame 10. The sidewall of the cooling balloon 501 is provided with a spray hole. After the fluid enters the cooling balloon 501, it is sprayed out from the spray hole to cool the electrode 20. One end of the delivery pipe 502 is connected to the cooling balloon 501, and the other end of the delivery pipe 502 passes through the first cavity 300a. It will be understood that in another embodiment, the cooling assembly 500 includes multiple cooling pipes, and the multiple cooling pipes are passed through the first cavity 300a. The distal ends of the cooling pipes pass through the distal end of the first cavity 300a and bend toward the radial outside of the support frame 10. The fluid is sprayed from the distal end of the cooling pipe to cool the electrode 20. It is understandable that when the pushing part 200 includes a connecting part 202, and the connecting part 202 is a tubular structure, the cooling component 500 passes through the first cavity 300a and the second cavity 300b, and then passes through the tubular connecting part 202 of the pushing part 200 and multiple circumferentially arranged connecting arms 201 and then extends out.
[0138] The ablation device of the present invention limits the structures of two adjacent first deformable parts and second deformable parts in the same unit group to be the same or different. When the structures of two adjacent first deformable parts and second deformable parts are the same, in order to avoid the "pushing" problem in the prior art, the support strength of the first deformable parts and second deformable parts in the same unit group is set unevenly, aiming to break the self-support balance of a single deformable part and construct local deformation in addition to its own support, thereby avoiding continuous "pushing" through the local deformation of the two deformable parts in the same unit group. When the structures are different, the support strength of the two parts is changed by the structure, and the difference in support strength between the two parts is increased, so that one of them deforms first, breaks the relative balance, and thus avoids continuous circumferential resistance. And / or the radial angles of the distal end deviation of two adjacent first deformable parts and second deformable parts in the same unit group are different, that is, the two adjacent deformable parts in the same unit group are staggered to avoid "pushing" when gathered.
[0139] The ablation device of the present invention optimizes and changes the structure of the deformable part in the deformable unit to weaken or eliminate the supporting force between the two deformable parts in the same group of units when they are subject to radial constraints, so that under the same force, compared with the prior art, at least one of the adjacent first deformable part and the second deformable part in the present invention is more likely to deform, and / or the two are more likely to be dislocated, thereby avoiding "pushing" together to cause damage through deformation and / or dislocation, reducing risks, and at the same time reducing the external force required for sheathing, thereby reducing the difficulty of sheathing.
[0140] As mentioned in the background technology of this application, when the umbrella-shaped electrode support unit 10' initially enters the sheath, the proximal end of the support unit (i.e., B' in Figure 1) will form a hard squeeze with the outer sheath 400'. At this time, not only is it difficult to enter the sheath, which may easily lead to damage at this point, but the movement of the support unit 10' at this point is also restricted in the state of being offset, which is not conducive to the formation of an interlaced shape of the umbrella-shaped structure. This also invisibly aggravates the problem of the distal end of the support unit. The present invention will exemplarily solve this problem through the following embodiments. It should be noted that the structures of the following embodiments can be arbitrarily combined without conflict with the above. The structures and effects of the specific components involved in the following embodiments can also refer to the above.
[0141] The present invention also exemplarily provides an ablation device 1000, comprising a push portion 200 and an ablation member 100 connected to the distal end of the push portion 200. The ablation member 100 has a first state in which it self-expands into a funnel shape when unconstrained, and a second state in which it deforms and converges when radially constrained. The ablation member 100 includes a support frame 10, which includes a plurality of deformable units 11 located at the distal end. The plurality of deformable units 11 are circumferentially arranged, adjacent to each other, and each can independently deform relative to the adjacent deformable units 11. The various structures and effects of the ablation member 100 of this embodiment may refer to any of the aforementioned embodiments and will not be further described here.
[0142] 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 .
[0143] Exemplarily, each deformation unit 11 includes a first deformation portion 11a and a second deformation portion 11b connected in the circumferential direction, and a first deformation portion 11a of each deformation unit 11 is adjacent to a second deformation portion 11b of an adjacent deformation unit 11; the support skeleton 10 also includes a plurality of main support rods 12, which are arranged at intervals in the circumference, and 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 portions 11a and second deformation portions 11b in two adjacent deformation units 11. Exemplarily, a gap 11c exists between the proximal ends of two adjacent first deformation portions 11a and second deformation portions 11b in two adjacent deformation units 11, and the circumferential spacing of the gap 11c gradually decreases from near to far along the extension direction. Illustratively, the main support rod 12 is provided with a first through-hole 121 through which the wire 30 can pass. The wire 30 can then 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, while the remaining wires are located inside. The length of the wire 30 located outside is shorter than that located inside. The structures and effects of the deformation unit 11, the first deformation unit 11b, the second deformation unit 11b, and the main support rod 12 of this embodiment can be referenced to any of the aforementioned embodiments and are not further elaborated here.
[0144] As shown in Figures 22 and 26 , in order to achieve the connection between the push portion 200 and the push tube 300, the push portion 200 of this embodiment further includes a connecting portion 202 having a preset axial extension length. The proximal ends of the multiple connecting arms 201 are simultaneously connected to the distal end of the connecting portion 202, and the proximal end of the connecting portion 202 is connected to the distal end of the push tube 300. In one embodiment, the connecting portion 202 is a tubular structure, and the connecting portion 202 and the push tube 300 are mutually sleeved to achieve the connection. In another embodiment, the connecting portion 202 is a tubular structure, and a recessed portion 202a is concavely provided on the outer surface of the connecting portion 202. The recessed portion 202a penetrates the wall of the connecting portion 202. When the connecting portion 202 and the push tube 300 are connected, the hot melt material enters the recessed portion 202a by hot melting, thereby achieving the connection. Preferably, in order to improve the connection strength, a plurality of recessed portions 202 a are provided, and the plurality of recessed portions 202 a all penetrate the tube wall of the connecting portion 202 . The plurality of recessed portions 202 a are spaced apart along the axial direction and / or circumferential direction of the connecting portion 202 .
[0145] 22 and 28 , in the present embodiment, in order to minimize the outer diameter of the entire ablation device 1000 while achieving the connection between the push tube 300 and the push portion 200, the ablation device 1000 of the present 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 portion 200. The sleeve 600 is simultaneously sleeved on the push tube 300 and the push portion 200. The sleeve 600 is relatively fixed to the push tube 300. The inner portion of the sleeve 600 extends into the recessed portion 202a to relatively fix the sleeve 600 to the connecting portion 202, thereby achieving relative fixation of the sleeve 600, the push tube 300 and the push portion 200. This method can be achieved through heat fusion. As shown in Figure 28, the pusher unit 200 and the pusher tube 300 are butted together front to back, and the sleeve 600 is placed over them. Then, heat fusion is performed. The first section 601 of the sleeve 600 is heat fused to secure it to the pusher tube 300. The second section 602 of the sleeve 600 is heat fused so that it partially enters the multiple recesses 202a on the connecting portion 202, thereby securing the sleeve 600 to the pusher unit 200. The butting, sleeve-fitting, and heat fusion methods of this embodiment not only achieve connection but also facilitate minimizing the outer diameter. For example, the pusher unit 200 of the present invention and the support frame 10 of the ablation element 100 can be integrally formed, for example, by integral cutting and heat setting. Materials such as nickel-titanium alloy and stainless steel can be used. The pusher tube 300, sleeve 600, and outer sheath 400 can be made of polymer materials. In particular, the pusher tube 300 and sleeve 600 can be made of polymer materials that have good bonding properties at high temperatures to ensure a strong bond after fusion. For example, the push tube 300 may be a nylon tube, the sleeve 600 may be a pebax tube, and the outer sheath tube 400 may be a PVDF tube. Of course, the materials and forming methods are not limited thereto.
[0146] In other embodiments, the connecting portion 202 of the pushing portion 200 is relatively fixed to the sleeve 600, and the multiple connecting arms 201 are disposed within the sleeve and are circumferentially movable within the sleeve. Specifically, the multiple connecting arms 201 are circumferentially movable within the third section 603 of the sleeve 600. In other words, the third section 603 of the sleeve 600 provides axial support but does not block or limit the circumferential movement of the multiple connecting arms 201. This ensures that the multiple connecting arms 201 remain independent rods with circumferential freedom, allowing each rod to move relative to each other, thereby facilitating the deformation of the deformable unit 11 of the ablation member 100 into a staggered configuration.
[0147] 26 and 27 , the recessed portion 202a includes an arcuate notch formed around the circumference of the connecting portion 202, and a plurality of arcuate notches are spaced apart along the length direction of the connecting portion 202. The spaced apart arcuate notches are arranged in a spiral shape on the outer circumference of the connecting portion 202, such as the spiral shape L shown in FIG27 . In other embodiments, the arc angles of the plurality of arcuate notches gradually increase from the distal end to the proximal end; in another embodiment, the axial widths of the plurality of arcuate notches decrease successively from the distal end to the proximal end. In another embodiment, the spacing distances between the plurality of arcuate notches decrease successively from the distal end to the proximal end. The arcuate notches and the spiral arrangement of the present embodiment can, on the one hand, effectively ensure the connection strength and axial support, and can form a stable connection and strong support in both the axial and circumferential directions, thereby ensuring the support and pushing force of the connecting portion on the front end support unit. On the other hand, a certain bending performance can be formed, so that when the push tube 300 drives the push part 200 to move axially, it carries 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 a staggered form and forms a trend of rotation and convergence into the sheath. This not only avoids the hard abutment into the sheath shown by B' in Figure 1, but also drives the distal end to rotate and deform to a certain extent, avoiding the distal end from contacting. This method makes it easier to sheath and avoid damage. In addition, it also reduces the strength of the push part 200 formed by cutting to a certain extent, making the distal end of the ablation device 1000 more flexible, and more easily entering a preset position in the human body.
[0148] Furthermore, as shown in Figures 22 and 23 , the ablation device 1000 further includes an outer sheath 400 that is sheathed over the pushing portion 200. The outer sheath 400 and the pushing portion 200 are axially movable relative to each other, allowing the ablation element 100, located at the distal end of the pushing portion 200, to be retracted into or extended from the outer sheath 400. In other embodiments, the ablation element 100 is eccentrically positioned relative to the outer sheath 400, so that when the ablation element 100 is retracted into the outer sheath 400, it is subjected to uneven circumferential compression. In other words, the ablation element 100 and the outer sheath 400 are non-coaxially positioned. As shown in Figure 23, the central axis of the ablation component 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 component 100 is received into the outer sheath tube 400, since the ablation component 100 is eccentrically arranged relative to the outer sheath tube 400, the ablation component 100 is subjected to different forces from the outer sheath tube 400 in the circumferential direction, and there is a local greater force. The corresponding deformation unit 1111 is slightly tilted inward compared to other deformation units 11, which is more conducive to forming dislocation, facilitating the reduction of circumferential abutment, and timely sheath insertion.
[0149] The ablation device of the present invention connects a plurality of circumferentially spaced connecting arms to the ablation component. When the ablation component moves axially into the sheath, the strength of the connection between the two is reduced, making it easier to insert the ablation component into the sheath. At the same time, since the connecting arms are independent of each other, the independent connecting arms spaced apart from each other have a certain amount of movement space in the circumferential direction. When the ablation component is subject to radial constraints, the connecting arm connected to it can move in the circumferential direction, and this movement can further form a trend of circumferential rotation into the sheath, so that the ablation component can be inserted into the sheath more easily and smoothly. In addition, the circumferential movement of the connecting arm is more conducive to driving the deformation unit at the distal end to move and form an interlaced shape, thereby further reducing the problem of continuous phase contact at the distal end.
[0150] The technical features of the above embodiments can be combined arbitrarily. In order to make the description concise, 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, they should be considered to be within the scope of the present invention.
[0151] The above embodiments merely illustrate several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.
Claims
1. An ablation device, characterized in that, It includes a pushing member and an ablation member connected to the distal end of the pushing member. 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 and arranged, and the enclosed plurality of deformation units are adjacent to each other and can all deform independently relative to the adjacent deformation units; each deformation unit includes a first deformation part and a second deformation part connected in the circumferential direction, and one first deformation part of each deformation unit is adjacent to one second deformation part of the adjacent deformation unit; wherein, the structures of the two adjacent first deformation parts and the second deformation parts in two adjacent deformation units are the same or different; when the structures of the two adjacent first deformation parts and the second deformation parts are the same, the support strengths of the first deformation part and the second deformation part are both unevenly arranged; and / or, the radially deviated angular degrees of the distal ends of the two adjacent first deformation parts and the second deformation parts in two adjacent deformation units are different.
2. The ablation device according to claim 1, wherein When the structures of the two adjacent first deformation parts and the second deformation parts are the same, the rod diameters of the first deformation part and the second deformation part are both unevenly arranged.
3. The ablation device according to claim 2, wherein, The rod diameters of the distal sides of the two adjacent first deformation parts and the second deformation parts are both smaller than the rod diameters of their respective proximal sides, so that the deformation capabilities of the distal sides of the first deformation part and the second deformation part are both greater than the deformation capabilities of their respective proximal sides.
4. The ablation device according to claim 3, characterized in that, The first deformation part includes a first wall-attaching part extending in the circumferential direction and a first support arm connected to the end of the first wall-attaching part; the second deformation part includes a second wall-attaching part extending in the circumferential direction and a second support arm connected to the end of the second wall-attaching part, and the first support arm and the second support arm both extend along the extending direction of the ablation member; wherein, the rod diameters of the first wall-attaching part and the second wall-attaching part are respectively smaller than the maximum rod diameters of the first support arm and the second support arm.
5. The ablation device according to claim 4, wherein The first support arm includes a first section and a second section connected along its extending direction, the distal end of the first section is connected to the end of the first wall-attaching part, the second support arm includes a third section and a fourth section connected along its extending direction, and the distal end of the third section is connected to the end of the second wall-attaching part; wherein, the rod diameters of the first section and the third section are respectively smaller than the rod diameters of the second section and the fourth section.
6. The ablation device according to claim 5, characterized in that The rod diameter of the first wall-attaching part is not greater than the rod diameter of the first section, and the rod diameter of the second wall-attaching part is not greater than the rod diameter of the third section.
7. The ablation device according to claim 5, wherein, The rod diameters of the second section and the fourth section gradually increase from far to near.
8. The ablation device according to claim 4, characterized in that, The first wall-attaching part and the first support arm are arc-connected, and the second wall-attaching part and the second support arm are arc-connected.
9. The ablation device according to any one of claims 1 to 8, characterized in that, When the structures of two adjacent first deformation parts and second deformation parts are different, the support strength between the two adjacent first deformation parts and second deformation parts is unevenly set, so that the deformation ability of the deformation part with a small support strength is greater than that of the deformation part with a large support strength.
10. The ablation device according to claim 8, wherein, The first deformation part includes a first wall-attaching part extending in the circumferential direction and a first support arm connected to the end of the first wall-attaching part; the second deformation part includes a second wall-attaching part extending in the circumferential direction and a second support arm connected to the end of the second wall-attaching part, and both the first support arm and the second support arm extend along the extending direction of the ablation member; wherein, the rod diameter of the first support arm is different from that of the second support arm.
11. The ablation device according to any one of claims 1 to 10, characterized in that, When the structures of two adjacent first deformation parts and second deformation parts are different, at least one of the adjacent first deformation part and second deformation part is provided with a guiding structure and / or a guiding member at their relative positions, so that when the ablation member is radially constrained, the first deformation part and the second deformation part can generate radial displacement under the guiding action of the guiding structure and / or the guiding member.
12. The ablation device according to claim 11, wherein, The guiding structure includes a first inclined surface obliquely arranged on the side of the first deformation part and a second inclined surface arranged on the side of the second deformation part and cooperating with the first inclined surface.
13. The ablation device according to any one of claims 1 to 11, characterized in that, When the radially deviated angles of the distal ends of two adjacent first deformation parts and second deformation parts are different, the two adjacent first deformation parts and second deformation parts are radially misaligned, so that at least the distal ends of the two adjacent first deformation parts and second deformation parts are not deformed on the same circumference at the same time.
14. The ablation device according to claim 13, wherein The distal end side of the first deformation part is inclined inwards / outwards relative to the second deformation part, so that at least the distal ends of the first deformation part and the second deformation part are not deformed on the same circumference at the same time when the ablation member is radially constrained.
15. The ablation device according to any one of claims 1 to 14, characterized in that, The support skeleton further includes a plurality of main support rods, and the plurality of main support rods are circumferentially spaced apart. The proximal end of each main support rod is connected to the distal end of the pushing member, and the distal end of each main support rod is simultaneously connected to the proximal ends of two adjacent first deformation parts and second deformation parts.
16. The ablation device according to claim 15, wherein, The rod diameter of the main support rod gradually decreases from the distal end to the proximal end.
17. The ablation device according to claim 15, characterized in that, There is a gap between the proximal end sides of two adjacent first deformation parts and second deformation parts, and the circumferential pitch of the gap gradually decreases from the proximal end to the distal end along the extending direction.
18. The ablation device according to claim 17, wherein, The main support rod is further provided with a first through hole through which a wire can pass, and 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.
19. The ablation device according to any one of claims 1 to 18, characterized in that, The ablation member further includes a wire and an electrode, the electrode is arranged on the support skeleton, and the wire is connected to the electrode.
20. The ablation device according to claim 19, characterized in that, The electrode includes a first electrode and a second electrode respectively disposed on two adjacent first deformation parts and the second deformation parts, wherein the distance between the first electrode and the end of the first deformation part is not equal to the distance between the second electrode and the end of the second deformation part.
21. The ablation device according to claim 20, wherein, The wire includes an exposed part, which is located between the electrode and the support frame and at least partially adheres to the inner wall of the electrode.
22. The ablation device according to any one of claims 1 to 21, characterized in that, The ablation device further includes an outer sheath sleeved outside the pusher, and the outer sheath and the pusher can move axially relative to each other so that the ablation member located at the distal end of the pusher can be retracted / extended from the outer sheath; wherein, the ablation member is eccentrically arranged relative to the outer sheath so that when the ablation member is retracted into the outer sheath, the ablation member can be unevenly squeezed in the circumferential direction.
23. The ablation device according to claim 22, wherein, The pusher includes a push tube, and a first cavity and a second cavity are formed in the push tube, and the second cavity is disposed on the side of the first cavity in a substantially crescent-shaped offset manner.
24. The ablation device according to any one of claims 1 to 23, characterized in that, The pushing part includes a plurality of connecting arms disposed at the distal end, the plurality of connecting arms are circumferentially spaced, and the free ends of the plurality of connecting arms are respectively connected to the proximal ends of the plurality of deformation units.
25. The ablation device according to claim 24, wherein The support frame further includes a plurality of main support rods, the plurality of main support rods are circumferentially spaced, 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 among two adjacent deformation units.
26. The ablation device according to claim 25, wherein, There is a gap between the proximal sides of two adjacent first deformation parts and two adjacent second deformation parts among two adjacent deformation units, and the circumferential pitch of the gap gradually decreases from near to far along the extending direction.
27. The ablation device according to claim 26, wherein, A first through hole for the wire to pass through is provided on the main support rod, and 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.
28. The ablation device according to any one of claims 24 to 27, characterized in that 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, and a plurality of recessed parts are concavely provided on the outer surface of the connecting part, and the plurality of recessed parts are spaced at intervals along the axial direction and / or the circumferential direction of the connecting part.
29. The ablation device according to claim 28, wherein The ablation device further includes a push tube and a sleeve, and the distal end of the push tube is axially opposite to the proximal end of the pushing part; The sleeve is simultaneously sleeved on the push tube and the pushing part, the sleeve is relatively fixed to the push tube, and an 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 push tube and the pushing part.
30. The ablation device according to claim 29, 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.
31. The ablation device according to claim 28, wherein, The recessed portion includes an arc-shaped notch formed circumferentially around the connecting portion, and a plurality of the arc-shaped notches are arranged at intervals along the length direction of the connecting portion, and the plurality of arc-shaped notches arranged at intervals are spirally arranged on the outer periphery of the connecting portion.
32. The ablation device according to any one of claims 24 to 31, characterized in that, The ablation device further includes an outer sheath sleeved outside the pushing portion, and 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 in the outer sheath, the ablation member can be unevenly squeezed circumferentially.
33. The ablation device according to any one of claims 24 to 32, characterized in that, The ablation device further includes a pushing tube, and a first cavity and a second cavity are defined in the pushing tube, and the second cavity is substantially arranged in a crescent shape and offset on the side of the first cavity.
34. An ablation device, characterized in that, It includes a pushing portion and an ablation member connected to the distal end of the pushing portion. The ablation member has a first state in which it unfolds into a funnel shape 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 located on the distal side. The plurality of deformation units are arranged circumferentially enclosing, and the plurality of enclosing deformation units are adjacent to each other and can independently deform relative to the adjacent deformation units; wherein, the pushing portion includes a plurality of connecting arms arranged at the distal end, the plurality of connecting arms are arranged at intervals circumferentially, and the free ends of the plurality of connecting arms are respectively connected to the proximal ends of the plurality of deformation units.
35. The ablation device according to claim 34, wherein, Each of the deformation units includes a first deformation portion and a second deformation portion connected circumferentially, and one of the first deformation portions of each deformation unit is adjacent to one of the second deformation portions of the adjacent deformation unit. The support skeleton further includes a plurality of main support rods arranged at intervals circumferentially. 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 portions and two adjacent second deformation portions in two adjacent deformation units.
36. The ablation device according to claim 35, wherein, There is a gap between the proximal sides of two adjacent first deformation portions and two adjacent second deformation portions in two adjacent deformation units, and the circumferential pitch of the gap gradually decreases from near to far along the extending direction.
37. The ablation device according to claim 36, wherein, A first through hole for the wire to pass through is provided on the main support rod, and 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.
38. The ablation device according to any one of claims 34 to 37, characterized in that, The pushing portion further includes a connecting portion having a preset axial extension length, and the proximal ends of the plurality of connecting arms are simultaneously connected to the distal end of the connecting portion. A plurality of recessed portions are concavely provided on the outer surface of the connecting portion, and the plurality of recessed portions are arranged at intervals along the axial direction and / or the circumferential direction of the connecting portion.
39. The ablation device according to claim 38, wherein, 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 portion. The sleeve is sleeved on both the push tube and the push part at the same time. The sleeve is relatively fixed to the push 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 push tube and the push part.
40. The ablation device according to claim 39, wherein, The connecting part of the push 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.
41. The ablation device according to claim 38, wherein, 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.
42. The ablation device according to any one of claims 34 to 41, characterized in that, The ablation device further includes an outer sheath tube sleeved outside the push part. The outer sheath tube and the push part can move axially relative to each other so that the ablation member located at the distal end of the push 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 in the circumferential direction.
43. The ablation device according to any one of claims 1 to 42, characterized in that, The ablation device further includes a push tube. A first cavity and a second cavity are formed in the push tube. The second cavity is disposed substantially in a crescent shape and offset to the side of the first cavity.
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