A scoring structure and scoring balloon

Abstract

The utility model belongs to the technical field of medical apparatus and instruments, concretely relates to a score structure and score balloon, score structure includes the score silk at the surface of balloon and is provided with the fixing piece at the both ends of score silk, the fixing piece is annular hollow structure, the one end away from score silk on the fixing piece is provided with the fixed ring, the utility model has high connecting strength, is not easy to fall off, further improves the overbending capacity, reduces the operation risk, improves the security.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a scoring structure and a scoring balloon. Background Technology

[0002] Medical balloon dilation catheters can be used in a variety of treatments. For example, during angioplasty, balloons can be used to dilate occluded blood vessels, opening vascular access, followed by the implantation of stents or drug-eluting balloons to ensure long-term blood flow patency. For high-resistance lesions, conventional balloon dilation catheters (cylindrical bare balloons without special structures) may have poor dilation effects, such as failing to effectively dilate the lesion, making subsequent treatment impossible, or causing disordered tearing and significant damage to the blood vessel.

[0003] For high-resistance lesions, the commonly used approach is to use high-pressure balloons or specially structured cutting and scoring balloons for treatment. Compared to cutting balloons, scoring balloons have better permeability but slightly less dilation effect.

[0004] There are currently two main structures for scored balloons: The first structure involves a scored component spanning the balloon surface, connecting the proximal and distal ends without being adhesively fixed to the balloon. The advantages of this design are its ease of bending, good maneuverability, and high connection strength of the scored component; even if it breaks, it will not detach and remain inside the body, posing a relatively low risk. The second structure involves the scored component directly bonded to the balloon surface. The advantage of this design is that the scored component can be perfectly divided into three parts within the body. The disadvantage is that the balloon's flexibility is limited by the scored component, resulting in poor maneuverability, and the scored component detaching within the body can lead to serious adverse events, endangering the patient's life. Utility Model Content

[0005] The technical problem to be solved by this utility model is to provide a notched structure and a notched balloon with high connection strength, which is not easy to fall off, further improves bending ability, reduces surgical risk and improves safety.

[0006] This utility model embodiment provides a scoring structure, including scoring wires located on the surface of the balloon and fixing members disposed at both ends of the scoring wires. The fixing members are annular hollow structures, and a fixing ring is provided at the end of the fixing members away from the scoring wires.

[0007] Optionally, the fastener includes a fastener body and a pull rod connected to each other, the pull rod being connected to the scoring wire;

[0008] Optionally, the diameter of the pull rod decreases from the fastener body towards the scoring wire direction;

[0009] The fastener body and / or the tie rod are provided with through holes; the through holes are located inside the fastener body and / or the tie rod, or / and, the through holes are located between the fastener body and the fixing ring.

[0010] Optionally, it also includes a sleeve fitted around the periphery of the fastener, the material portion of which is embedded within the cutout.

[0011] Optionally, the sleeve also covers the serrated wire connected to the fastener.

[0012] Optionally, the fastener includes several fastener units (the number of fastener units preferably corresponds to the number of scribe lines), and the fastener unit unfolds into a triangular or quadrilateral shape.

[0013] Optionally, the triangle is an isosceles triangle, the quadrilateral is a rhombus, and the corners of the triangle or quadrilateral are connected to corresponding scribe lines.

[0014] Optionally, the fastener unit has a through hole inside, and the shape of the through hole can be circular, quadrilateral, or triangular, etc. Preferably, the shape of the through hole matches the shape of the fastener unit.

[0015] Optionally, the fastener unit has multiple through holes inside, which are not connected to each other, and reinforcing ribs are provided between the multiple through holes to improve the connection strength.

[0016] Optionally, adjacent fastener units are directly connected and connected by a retaining ring.

[0017] Optionally, the number of scoring wires is 2-4; the cross-section of the scoring wire is triangular.

[0018] This utility model embodiment provides a scoring balloon, including the scoring structure, and also includes a balloon, an inner tube, and an outer tube. The inner tube is disposed inside the outer tube. The distal end of the balloon is fixed to the inner tube, and the proximal end of the balloon is fixed to the outer tube. The scoring wire is located on the surface of the balloon. The distal end of the scoring wire is fixed to the inner tube by a fixing member, and the proximal end of the scoring wire is fixed to the outer tube by a fixing member.

[0019] Optionally, the scoring balloon also includes a cannula fitted around the periphery of the fixation member; the fixation member is fixed inside the cannula; and the cannula is wholly or partially fixed to the inner or outer tube.

[0020] When all the sleeves are fixed to the inner or outer tube, it is equivalent to sequentially fitting and fixing the inner or outer tube, the fastener, and the sleeve from the inside out. All the sleeves are connected and fixed to the inner or outer tube and the fastener, resulting in high connection strength.

[0021] There is a gap between the non-fixed section of the sleeve and the inner or outer tube. The fixed section of the sleeve refers to the part of the sleeve that is fixed to the inner or outer tube when the sleeve is fixed to it. The non-fixed section of the sleeve refers to the other parts of the sleeve.

[0022] That is, the sleeve portion is fixed to the inner or outer tube, and the other portion of the sleeve has a gap with the inner or outer tube; generally speaking, it means that one end of the sleeve (i.e., the sleeve portion) is fixed to the inner or outer tube, and the other end of the sleeve (i.e., the other portion of the sleeve) is fixed to the fixing element. Therefore, the sleeve fixed to the fixing element is not connected to the inner or outer tube, that is, the other portion of the sleeve has a gap with the inner or outer tube, which provides a certain elastic compensation for the scoring wire.

[0023] Preferably, the sleeve includes a proximal sleeve and a distal sleeve fitted around the periphery of the fixing member; that is, the proximal sleeve is fitted around the periphery of the fixing member at the proximal end, and the distal sleeve is fitted around the periphery of the fixing member at the distal end.

[0024] The distal sleeve, the distal fixing member, and the inner tube are fixedly connected;

[0025] One end of the proximal sleeve is fixedly connected to the proximal fixing member and has a gap between it and the outer tube, while the other end of the sleeve is fixedly connected to the outer tube.

[0026] Optionally, the distal fastener includes a fastener unit corresponding to the number of scoring wires, and the fastener unit unfolds into a triangular shape; the proximal fastener includes a fastener unit corresponding to the number of scoring wires, and the fastener unit unfolds into a quadrilateral shape.

[0027] The sleeve is made of an elastic material.

[0028] The beneficial effects of this invention are that the fixing component has a hollow structure, which has greater overall flexibility and lower rigidity, resulting in better maneuverability. This improves the balloon catheter's ability to navigate bends and makes it easier to reach tortuous lesion locations. The hollow structure also forms an anchoring structure, effectively increasing connection strength and reducing the risk of dislodgement.

[0029] The fixing member of this utility model has a fixing ring at the end away from the scoring wire. The fixing ring can reduce the risk of the hollow fixing member lifting up at the end and scratching blood vessels. At the same time, the fixing ring can effectively distribute the force of the scoring wire on the fixing member unit to the entire fixing member, thereby improving the connection firmness. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the notched structure of this utility model.

[0031] Figure 2 This is a schematic diagram of the structure of the notched balloon of this utility model.

[0032] Figure 3 This is a schematic diagram of the proximal fixation component of this utility model.

[0033] Figure 4 This is a schematic diagram of the structure of the remote fixing component of this utility model.

[0034] In the figure, 1 is the distal fixation component, 11 is the distal fixation ring, 12 is the distal fixation body, 13 is the distal traction rod, 14 is the distal through hole, 2 is the scoring wire, 3 is the proximal fixation component, 31 is the proximal fixation ring, 32 is the proximal fixation body, 33 is the proximal traction rod, 34 is the proximal through hole, 4 is the cannula, 41 is the cannula fixation area, 5 is the balloon, 6 is the inner tube, and 7 is the outer tube. Detailed Implementation

[0035] Example 1

[0036] like Figure 1-2 As shown, the scoring structure of this utility model includes scoring wires 2 located on the surface of the balloon 5 and fixing members disposed at both ends of the scoring wires 2. The fixing members are annular hollow structures, and a fixing ring is provided at the end of the fixing members away from the scoring wires 2.

[0037] like Figure 2 As shown, the scoring wire of this utility model is fixed by a fixing member. Therefore, the scoring wire 2 does not need to be bonded to the balloon 5. The scoring wire 2 is only located on the surface of the balloon 5. Of course, the scoring wire 2 can also be bonded to the balloon 5 to improve its fixing firmness and further define the position of the scoring wire 2.

[0038] The number of the scoring wires 2 is 2-4, such as Figure 1 As shown, the number of scoring wires 2 is 3. The number of scoring wires can be determined as needed. 3 wires can achieve circumferential 120° extrusion cutting, which can cope with most scenarios. Therefore, the number of scoring wires 2 is more preferably 3. The scoring wires 2 and the fixing parts can be fixed by welding to ensure the three-part division and connection strength of the fixing parts and the scoring wires 2.

[0039] like Figure 1 As shown, the fastener is an unfolding structure, and in actual use, it is as follows: Figure 2 As shown, the fixing element is a ring structure. After the fixing element is closed, the scoring wire 2 is located on the surface of the balloon 5 (generally multiple scoring wires 2, generally evenly dispersed).

[0040] The fastener has a hollow structure (which can be obtained by laser cutting), meaning that the fastener has through holes, i.e., holes are drilled in the fastener. The shape of the through holes can be various, such as circles, triangles, quadrilaterals, etc. Preferably, the shape of the through holes matches the shape of the fastener. The hollow structure makes the connection of the fastener more flexible and easy to bend.

[0041] A fixing ring is provided at one end of the fixing member away from the scoring wire 2. The fixing ring is preferably a complete circular ring without holes. Of course, the fixing ring can also be a curved ring, but the curvature should not be too large to ensure that the risk of the end of the hollow fixing member lifting up and scratching the blood vessel is reduced.

[0042] A fixing ring is provided at the end of the fixing member away from the scoring wire 2. The closed ring structure of the fixing ring can reduce the risk of the mesh end of the hollow fixing member lifting up and scratching the blood vessel. Moreover, the hollow structure of the fixing member can better form an anchoring structure with the cannula 4, improve the welding strength, and reduce the risk of falling off. On the other hand, compared with a solid metal ring, the hollow structure increases the bending ability of the ring structure and reduces the stiffness, which can improve the bending ability of the balloon catheter 6 and make it easier to reach the tortuous lesion location.

[0043] The fastener includes a fastener body and a pull rod connected to each other, and the pull rod is connected to the scoring wire 2. The number of pull rods and scoring wires 2 are in one-to-one correspondence.

[0044] The diameter of the pull rod decreases from the fixing body towards the scoring wire 2.

[0045] The fastener body and / or the tie rod are provided with through holes; the through holes are located inside the fastener body and / or the tie rod, or / and, the through holes are located between the fastener body and the fixing ring.

[0046] The fastener includes fastener units corresponding to the number of scribe wires 2, and the fastener units are unfolded into a triangular or quadrilateral shape.

[0047] The triangle is an isosceles triangle, and the quadrilateral is a rhombus. The corners of the triangle or quadrilateral are connected to the corresponding scoring wires. The corner of the triangle refers to the corner where the vertex of the isosceles triangle is located, and the corner of the quadrilateral refers to the corner where the acute angle of the rhombus is located, so as to ensure that the scoring wire 2 is subjected to more concentrated force when pulled, thereby improving tensile strength.

[0048] The fastener unit has a through hole inside, and the shape of the through hole matches the shape of the fastener unit. Specifically, the through hole can be circular, elliptical, triangular, or quadrilateral, etc. That is, if the fastener unit is triangular, the through hole inside the fastener unit is also triangular, resulting in high tensile strength and fastening firmness.

[0049] The fastener unit can have a single through hole or multiple through holes. Reinforcing ribs are provided between the multiple through holes to improve the connection strength, which can strengthen the connection strength between the scoring wire, sleeve and fastener.

[0050] Adjacent fastener units are directly connected and connected by a fastening ring. Direct connection means connecting wide fastener units; for example, if a fastener unit is a triangle, the bases of adjacent triangles are connected; if a fastener unit is a rhombus, the middle portions (i.e., waists) of adjacent rhombuses are connected.

[0051] The fasteners located at both ends of the scoring wire 2 can be of the same shape or different shapes. Due to the different tapers at both ends of the balloon 5, it is more preferable that the fasteners located at both ends of the scoring wire 2 are fasteners of different shapes.

[0052] like Figure 1 As shown, the fixing component on the left is the distal fixing component 1. The distal fixing component 1 includes a distal fixing ring 11, a distal fixing body 12, and a distal traction rod 13 connected in sequence (the distal fixing ring 11, the distal fixing body 12, and the distal traction rod 13 are integrally formed).

[0053] In this invention, "proximal" and "distal" are relative to the user (i.e., the doctor). The end closer to the user is the proximal end, and the end farther from the user is the distal end. They are the opposite relative to the patient.

[0054] The distal fixing component 1 includes the number of scoring wires 2 ( Figure 1 For three corresponding fastener units, such as Figure 1 As shown, the fastener unit unfolds into a triangular shape, more preferably an isosceles triangle. The base of the isosceles triangle is the distal fixing ring 11. The sides of the isosceles triangle are connected to form a whole. The lower middle part of the two sides of the isosceles triangle constitutes the distal fixing body 12, and the upper middle part of the two sides of the isosceles triangle constitutes the distal traction rod 13. Therefore, the diameter of the distal traction rod 13 decreases from the distal fixing body 12 towards the scoring wire 2. The distal fastener 1 is provided with a distal through hole 14, which is triangular in shape (the orientation of the triangle is the same as that of the triangle in the fastener unit). The distal through hole 14 is located between the distal fixing body 12 and the distal fixing ring 11.

[0055] like Figure 1 As shown, the fastener on the right is the proximal fastener 3, which includes a proximal fastening ring 31, a proximal fastening body 32, and a proximal traction rod 33 connected in sequence (the proximal fastening ring 31, the proximal fastening body 32, and the proximal traction rod 33 are integrally formed).

[0056] The proximal fixation element 3 includes the number of scoring wires 2 ( Figure 1 For three corresponding fastener units, such as Figure 1 As shown, the fastener unit, when unfolded, is quadrilateral in shape, more preferably rhomboid. A proximal fixing ring 31 is provided on the rhomboid furthest from the scoring wire 2. The two long angles (i.e., the acute angles) of the rhomboid constitute the proximal fixing body 32 and the proximal traction rod 33. Therefore, the diameter of the proximal traction rod 33 decreases from the proximal fixing body 32 toward the scoring wire 2. A proximal through hole 34 is provided on the proximal fastener 3. The proximal through hole 34 is rhomboid in shape (the orientation of the rhomboid is the same as that of the rhomboid in the fastener unit). The proximal through hole 34 is located between the proximal fixing body 32 and the proximal fixing ring 31.

[0057] The hollow structure of this utility model is not only about the design of the through holes, but also about the variation in the diameter of the pull rods, i.e., the shape of the multiple fixing units. This results in multiple hollows (hollows between the through holes and the multiple pull rods) on the fixing units. On the one hand, this ensures connection strength, as the fixing units away from the scoring wire 2 have a larger area, and the hollows on them can form a stable connection structure with the sleeve 4. On the other hand, it has good passageability. In addition, after the scoring wire 2 is subjected to force, the force of each scoring wire 2 is concentrated on its corresponding fixing unit, and the force can be distributed through the fixing ring and adjacent fixing units, making its connection strength even higher. The fixing units are designed as triangles or quadrilaterals, and due to the shape limitation of the pull rods, the force on the scoring wire 2 is more controllable, the stress is more concentrated, and the position is less likely to shift.

[0058] like Figure 2-4 As shown, it also includes a sleeve 4 fitted around the periphery of the fastener (the inside of the fastener is an inner tube 6 or an outer tube 7), the sleeve 4 being embedded in the hollow structure. The sleeve 4 can be made of conventional thermoplastic materials or welding materials, etc., and can be melted into the hollow structure of the fastener, filling the space in the hollow structure with the material of the sleeve 4. At the distal end, the distal fastener 1 is not only clamped and limited by the sleeve 4 and the inner tube 6, but also limited by the material of the sleeve 4 that has penetrated into the hollow structure of the fastener, forming an anchoring structure, improving the fixing strength and reducing the risk of detachment.

[0059] like Figure 2 As shown, the sleeve 4 also covers the etched wire 2 connected to the fixation component. The sleeve 4 covers a portion of the etched wire 2 and completely encloses the welding position between the etched wire 2 and the fixation component, further enhancing the welding effect. Moreover, the sleeve 4 covers the welding position between the etched wire 2 and the fixation component, improving the transition between the etched wire 2 and the weld point into a smooth transition and reducing the risk of damage to blood vessels.

[0060] The cross-section of the scoring wire 2 is triangular, but it can also be other shapes, as long as scoring can be performed. The distribution of the scoring wire 2 on the balloon 5 is not limited; it can be linear, spiral, or mesh-like.

[0061] like Figure 2-4 As shown, the cannula 4 is wrapped around the distal fixation component 1 and covered with a small area of ​​the scoring wire 2 using laser welding technology. It is then fixed at the distal end of the balloon 5. This improves the protrusion at the welding position between the scoring wire 2 and the distal fixation component 1 into a smooth transition, reducing the risk of damage to blood vessels and ensuring that the distal fixation component 1 will not easily shift or deform during the expansion and contraction of the balloon 5.

[0062] The proximal fixation element 3 covers the cannula 4 and is fixed to the proximal end of the balloon 5. The elastic material of the cannula 4 not only provides sufficient fixation strength, but also compensates for the stretching effect of the balloon 5 expansion on the proximal fixation element 3, thereby preventing the proximal fixation element 3 from deforming.

[0063] Example 2

[0064] like Figure 2-4 As shown, a scoring balloon includes the scoring structure described in Embodiment 1, and further includes a balloon 5, an inner tube 6, and an outer tube 7. The inner tube 6 is disposed inside the outer tube 7. The distal end of the balloon 5 is fixed to the inner tube 6, and the proximal end of the balloon 5 is fixed to the outer tube 7. The scoring wire 2 is located on the surface of the balloon 5. The distal end of the scoring wire 2 is fixed to the inner tube 6 by a fixing member, and the proximal end of the scoring wire 2 is fixed to the outer tube 7 by a fixing member.

[0065] The end of the outer tube 7 is fixedly connected to one end of the balloon 5, and the other end of the balloon 5 is fixed to the outer surface of the inner tube 6. Therefore, the inside of the balloon 5 is only the inner tube 6. The balloon 5 is generally connected to the outside through a medium channel, that is, the balloon 5 is inflated and deflated through the medium channel. The medium channel is generally the channel between the inner tube 6 and the outer tube 7.

[0066] The shape of the fastener of this utility model can be triangular, square, rhomboid, circular, etc., preferably, such as Figure 2 As shown, the proximal fixation member 3 is preferably rhomboid, and the distal fixation member 1 is preferably triangular. Preferably, the distal fixation member (i.e., the distal fixation member 1) includes fixation units corresponding to the number of scoring wires 2, and the fixation units are triangular in shape when unfolded; the proximal fixation member (i.e., the proximal fixation member 3) includes fixation units corresponding to the number of scoring wires 2, and the fixation units are quadrilateral in shape when unfolded.

[0067] The use of a triangle at the distal end is to make the axial length of the fastener shorter, because the distal end needs to be more flexible to facilitate bending, and the shorter length will prevent the tip from sticking up and scratching the blood vessels.

[0068] It also includes a sleeve 4 fitted around the periphery of the fastener; the two sleeves 4 are respectively fitted around the periphery of the two fasteners and are fixedly connected to the two fasteners, that is, the fasteners are fixed inside the sleeves 4, that is, the material of the sleeves 4 fills the through hole of the fastener.

[0069] The sleeve is fixed in whole or in part to the inner tube 6 or the outer tube 7. When it is partially fixed to the inner tube 6 or the outer tube 7, the other part of the sleeve 4 will form a certain gap with the inner tube 6 or the outer tube 7. The sleeve 4 is made of elastic material, and the gap formed provides a certain elastic compensation for the scoring wire.

[0070] In one embodiment, the sleeve 4 includes a proximal sleeve and a distal sleeve fitted around the periphery of the fixing member. The distal sleeve, the distal fixing member, and the inner tube 6 are fixedly connected. At the distal end, the distal sleeve and the inner tube 6 together wrap and fix the fixing member, and the three are heat-fused into one piece. Due to the hollow design, the distal sleeve and the inner tube 6 can directly contact each other after heat fusion, making the fixation more reliable. That is, when the axial length of the distal fixing member 1 is relatively short, it also has high connection strength, which can better balance strength and passage.

[0071] One end of the proximal sleeve is fixedly connected to the proximal fixing member and has a gap between it and the outer tube 7, while the other end of the distal sleeve is fixedly connected to the outer tube 7.

[0072] The proximal end uses a diamond shape, and the proximal fixing member 3 is wrapped by the sleeve 4 (i.e., the proximal sleeve), that is, the two are heat-fused together. The proximal sleeve is relatively long. After a part of the proximal sleeve and the proximal fixing member 3 are heat-fused, this part, that is, the inner wall of the sleeve with the fixing member, is not bonded to the outer tube 7. That is, the inner wall of the sleeve with the fixing member is in a suspended state (i.e., there is a gap between the fixing member and the outer tube 7). The other part of the proximal sleeve, that is, the proximal sleeve ( Figure 2-3 The proximal end of the right-side cannula 4) (i.e. Figure 2-3 The right side of the tube is thermally fused with the outer tube 7 to form a single unit, as shown in the image. Figure 3 The sleeve fixing area 41 is shown. This semi-suspended setting allows the proximal sleeve to provide some elastic compensation to the scoring wire 2. The proximal sleeve and the proximal fixing member 3 are evenly connected and completely covered. Therefore, the proximal fixing member 3 needs a larger area and more perforations. Sufficient perforation structure allows the proximal sleeve and the proximal fixing member 3 to have a high connection strength.

[0073] The proximal cannula is made of an elastic material, such as spring steel or other metallic elastic materials, rubber, thermoplastic elastomers (such as TPU, TPEE), elastic fibers, etc. It only needs to have a certain degree of elasticity and strength. The elastic material is a conventionally known elastic material that can buffer the deformation caused by axial stretching during balloon expansion.

[0074] The balloon 5 is mounted on the balloon catheter 6, and two fixing members are mounted on the balloon catheter 6 at both ends of the balloon 5. The fixing members are fixed by the sleeve 4. The inflation of the balloon 5 causes the scoring wire 2 to expand, so as to compress the part to be cut.

[0075] Those skilled in the art should understand that the discussion of any of the above embodiments is merely exemplary and is not intended to imply that the scope of protection of this application is limited to these examples; within the framework of this application, the technical features of the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations of different aspects of one or more embodiments of this application as described above, which are not provided in detail for the sake of brevity.

[0076] One or more embodiments in this application are intended to cover all such substitutions, modifications, and variations that fall within the broad scope of this application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of one or more embodiments in this application should be included within the protection scope of this application.

Claims

1. A score structure, characterized by It includes a scoring wire (2) located on the surface of the balloon (5) and a fixing member set at both ends of the scoring wire (2). The fixing member has a ring-shaped hollow structure and a fixing ring is provided at the end of the fixing member away from the scoring wire (2).

2. The score structure of claim 1 wherein, The fastener includes a fastener body and a pull rod that are connected to each other, and the pull rod is connected to the scoring wire (2).

3. The score structure of claim 2 wherein, The diameter of the traction rod decreases from the fixing body towards the scoring wire (2).

4. The score structure of claim 2 wherein, The fastener body and / or the tie rod are provided with through holes; the through holes are located inside the fastener body and / or the tie rod, or / and, the through holes are located between the fastener body and the fixing ring.

5. A score structure according to any one of claims 1 to 4, wherein the score structure is formed from a material having a thickness of 0.1 to 0.5 mm. It also includes a sleeve (4) fitted around the periphery of the fastener, the material portion of which is embedded in the hollow.

6. The score structure of claim 5 wherein, The sleeve (4) is also covered by the serrated wire (2) that is connected to the fastener.

7. The score structure of claim 1 wherein, The fastener includes several fastener units, and each fastener unit has a through hole inside.

8. The score structure of claim 1 wherein, The fastener comprises several fastener units, which are directly connected to each other and connected by a fastening ring.

9. The score structure of any of claims 1-4, wherein the score structure is a beverage can end. The number of the scoring wires (2) is 2-4.

10. A notched balloon, characterized in that, The device includes the serrated structure as described in any one of claims 1-9, and further includes a balloon (5), an inner tube (6) and an outer tube (7), wherein the inner tube (6) is disposed inside the outer tube (7), the distal end of the balloon (5) is fixed to the inner tube (6), the proximal end of the balloon (5) is fixed to the outer tube (7), the serrated wire (2) is located on the surface of the balloon (5), the distal end of the serrated wire (2) is fixed to the inner tube (6) by a fastener, and the proximal end of the serrated wire (2) is fixed to the outer tube (7) by a fastener.

11. The notched balloon as claimed in claim 10, characterized in that, It also includes a sleeve (4) fitted around the periphery of the fastener; The fastener is fixed inside the sleeve (4); the sleeve (4) is fixed in whole or in part to the inner tube (6) or the outer tube (7).

12. The notched balloon as claimed in claim 11, characterized in that, There is a gap between the non-fixed section of the sleeve (4) and the inner tube (6) or the outer tube (7); the sleeve is made of an elastic material.

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