Nicking balloon catheter and preparation process thereof
By designing different hardness and elasticity in the scored wire section, the elastic deformation of the transition section is used to adapt to the balloon changes, the problems of permanent deformation of the scored wire and balloon damage are solved, and a stable cutting effect is achieved.
Patent Information
- Application Number
- CN202410046585.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-01-11
- Publication Date
- 2025-07-11
AI Technical Summary
Existing scintiles are prone to permanent deformation in the scinted balloon catheter or cause damage to the balloon, affecting the cutting effect.
Different hardness and elasticity are designed in different sections of the score wire, and the balloon length changes are adapted to the elastic deformation of the first and second transition sections, while the intermediate section remains stable to avoid additional deformation.
It reduces the additional pressure on the balloon, ensures the cutting performance of the score wire, and reduces the risk of score wire breakage and balloon damage.
Smart Images
Figure CN120285418A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and particularly to a notched balloon catheter and a preparation process thereof. Background Art
[0002] A notched balloon catheter is an interventional medical device with notched parts provided on the balloon. When the balloon is inflated, the notched parts can cut stenosis lesions such as calcification and plaque in the blood vessel, so that the balloon catheter can dilate the stenotic part of the blood vessel at a lower pressure, reducing the difficulty of blood vessel dilation and greatly reducing the risk of complications. Arranging notched wires outside the balloon catheter is a common structure of the notched balloon catheter. Among them, the notched wires attached to the outer wall of the balloon can cut the calcification and plaque when the balloon is inflated. Therefore, the stability and elasticity of the notched wires are crucial for the realization of the product function. If the hardness of the notched wire is too high, it may be permanently deformed and unable to rebound under excessive stress during balloon dilation, and the notched wire will generate a large pressure on the balloon when extending, resulting in the balloon being easily damaged; if the elasticity of the notched wire material is too high, it is easy to damage the balloon and the cutting effect on tissues is not good. Summary of the Invention
[0003] Based on this, the present invention provides a novel notched balloon catheter and a preparation process thereof, which set different hardness and elasticity in the length direction of the notched wire, solving the technical problems that the existing notched wires are prone to permanent deformation or are prone to damage the balloon while ensuring the cutting effect.
[0004] An object of the present invention is to provide a notched balloon catheter, which includes a proximal tube, a distal tube, a balloon sealingly connected to the proximal tube and the distal tube at both ends, and a notched wire axially attached to the outer wall of the balloon. The balloon includes a middle portion, a first transition portion and a second transition portion respectively connected to both ends of the middle portion. When the balloon is in a fully inflated state, the middle portion has substantially the same radial dimension along the axis. The radial dimension of the first transition portion gradually decreases from the distal end to the proximal end and is sealingly connected to the proximal tube. The radial dimension of the second transition portion gradually decreases from the proximal end to the distal end and is sealingly connected to the distal tube. The notched wire includes a middle section, a first transition section and a second transition section respectively connected to both ends of the middle section. The proximal end of the first transition section is fixedly connected to the proximal tube, and the distal end of the second transition section is fixedly connected to the distal tube. The tensile strength and elastic modulus of the middle section are greater than those of the first transition section and the second transition section; when the balloon is in a contracted and wound state, the notched wire is axially closely attached to the outside of the contracted and wound balloon or is wrapped by the contracted and wound balloon; when the balloon is in a fully inflated state, the middle section is axially attached to the outer wall of the middle portion, the first transition section undergoes elastic deformation and is attached to the outer wall of the first transition portion, and the second transition section undergoes elastic deformation and is attached to the outer wall of the second transition portion.
[0005] Further, the tensile strength of the middle section is 700 MPa - 1200 MPa, and the elastic modulus is 80 GPa - 240 GPa; the tensile strength of the first transition section and the second transition section is 1 MPa - 80 MPa, and the elastic modulus is 0.01 GPa - 4 GPa.
[0006] Further, the tensile strength and elastic modulus of the first transition section gradually decrease from the distal end to the proximal end; the tensile strength and elastic modulus of the second transition section gradually decrease from the proximal end to the distal end.
[0007] Further, the middle section is made of a metal material; the first transition section and the second transition section are made of a metal or a polymer material.
[0008] Further, the middle section is made of at least one material selected from stainless steel, titanium alloy, and nitinol alloy; the first transition section and the second transition section are made of nitinol alloy material, or made of at least one material selected from silicone rubber, thermoplastic elastomer, polyethylene, acrylate elastomer, and natural rubber.
[0009] Further, the radial cross-section of the middle section of the notched wire is circular, triangular, quadrilateral or irregular polygon, and the equivalent diameter of the middle section ranges from 0.15 mm to 0.5 mm; the radial cross-sections of the first transition section and the second transition section are circular or elliptical, and the equivalent diameters of the first transition section and the second transition section range from 0.1 mm to 0.3 mm.
[0010] Further, the equivalent diameter of the middle section is greater than or equal to the equivalent diameters of the first transition section and the second transition section.
[0011] The second object of the present invention is to provide a preparation process of a notched balloon catheter, comprising the following steps:
[0012] Provide a balloon catheter, the balloon catheter comprising a proximal tube, a distal tube and a balloon hermetically connected between the proximal tube and the distal tube, the balloon comprising a middle part and a first transition part and a second transition part respectively connected to both ends of the middle part;
[0013] Provide a notched wire, the notched wire comprising a middle section and a first transition section and a second transition section respectively connected to both ends of the middle section, the tensile strength of the middle section being 700 MPa - 1200 MPa and the elastic modulus being 80 GPa - 240 GPa; the tensile strength of the first transition section and the second transition section being 1 MPa - 80 MPa and the elastic modulus being 0.01 GPa - 4 GPa, the length of the notched wire in the natural state being the same as the length of the balloon when it is shrunk and wound, the length of the middle section being the same as the axial length of the middle part, when the balloon is inflated, the length of the first transition section after elastic deformation being the same as the side wall length of the first transition part, and the length of the second transition section after elastic deformation being the same as the side wall length of the second transition part;
[0014] Fix and connect both ends of the notched wire to the proximal tube and the distal tube respectively.
[0015] Further, the preparation steps of the notched wire are as follows:
[0016] Provide a metal wire, and through a heat treatment process, make the tensile strength of the middle section of the metal wire reach 700 MPa - 1200 MPa and the elastic modulus reach 80 GPa - 240 GPa; make the tensile strength of the two end sections of the middle section reach 1 MPa - 80 MPa and the elastic modulus reach 0.01 GPa - 4 GPa to obtain the notched wire.
[0017] The preparation steps of the notched wire are as follows:
[0018] Provide a metal wire and two polymer wires. The length of the metal wire is the same as that of the middle part of the balloon. The tensile strength of the metal wire is 700 MPa - 1200 MPa, and the elastic modulus is 80 GPa - 240 GPa. The tensile strength of the two polymer wires is 1 MPa - 80 MPa, and the elastic modulus is 0.01 GPa - 4 GPa. Bond the two polymer wires to both ends of the metal wire respectively to obtain a scored wire.
[0019] In the present invention, by designing the scored wire to have different material properties in different sections, during the inflation process of the balloon, the length change is mainly adapted through the elastic deformation of the first transition section and the second transition section, without causing additional external deformation of the middle section, thus ensuring the cutting performance of the middle section of the scored wire. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.
[0021] Figure 1 It is a schematic diagram of the scored balloon catheter provided by the embodiment of the present invention.
[0022] Reference numerals: 1 - proximal tube; 2 - distal tube; 3 - balloon; 31 - middle part; 32 - first transition part; 33 - second transition part; 4 - scored wire; 41 - middle section; 42 - first transition section; 43 - second transition section. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0023] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.
[0024] As Figure 1 shown, the first embodiment of the present invention provides a scored balloon catheter, including a proximal tube 1, a distal tube 2, a balloon 3 with both ends hermetically connected to the proximal tube 1 and the distal tube 2 respectively, and a scored wire 4 axially attached to the outer wall of the balloon 3.
[0025] Among them, the balloon 3 includes a middle portion 31, a first transition portion 32 and a second transition portion 33 respectively connected to both ends of the middle portion 31. When the balloon 3 is in a fully inflated state, the middle portion 31 has substantially the same radial dimension along the axial direction; the radial dimension of the first transition portion 32 gradually decreases from the distal end to the proximal end and is hermetically connected to the distal end of the proximal tube 1; the radial dimension of the second transition portion 33 gradually decreases from the proximal end to the distal end and is hermetically connected to the proximal end of the distal tube 2.
[0026] The notched wire 4 includes a middle section 41, a first transition section 42 and a second transition section 43 respectively connected to both ends of the middle section 41. The proximal end of the first transition section 42 is fixedly connected to the proximal tube 1, and the distal end of the second transition section 43 is fixedly connected to the distal tube 2. The tensile strength and elastic modulus of the middle section 41 are greater than those of the first transition section 42 and the second transition section 43. When the balloon 3 is in a contracted and wound state, the notched wire 4 is axially closely attached to the outer wall of the contracted and wound balloon 3 or is wrapped by the contracted and wound balloon 3; when the balloon 3 is in a fully inflated state, the middle section 41 of the notched wire 4 is axially attached to the outer wall of the middle portion 31 of the balloon 3, the first transition section 42 undergoes elastic deformation and is attached to the outer wall of the first transition portion 32, and the second transition section 43 undergoes elastic deformation and is attached to the outer wall of the second transition portion 33.
[0027] For the notched balloon catheter provided by the present invention, the notched wire 4 provided thereon has different material properties in different sections. During the balloon inflation process, the length change is mainly adapted by the elastic deformation of the first transition section 42 and the second transition section 43, without causing additional deformation of the middle section 41. The present invention reduces the additional pressure on the balloon while ensuring the cutting performance of the middle section 41 of the notched wire 4.
[0028] Further, the tensile strength of the middle section 41 of the notched wire 4 is 700 MPa - 1200 MPa, and the elastic modulus is 80 GPa - 240 GPa; the tensile strength of the first transition section 42 and the second transition section 43 is 1 MPa - 80 MPa, and the elastic modulus is 0.01 GPa - 4 GPa.
[0029] For the notched wire 4 provided by this solution, the first transition section 42 and the second transition section 43 have good deformation and recovery capabilities. The change in the fully inflated state of the balloon is mainly adapted by the deformation generated by the first transition section 42 and the second transition section 43, and it is not easy to cause deformation of the middle section 41, and it will not exert too much pressure on the fully inflated balloon 3 and is not easy to damage the balloon.
[0030] Furthermore, the tensile strength and elastic modulus of the first transition section 42 gradually decrease from the distal end to the proximal end; the tensile strength and elastic modulus of the second transition section 43 gradually decrease from the proximal end to the distal end. This solution can reduce the suddenly generated stress concentration, thereby greatly reducing the risk of the notch wire 4 breaking and compressing the balloon 3.
[0031] It should be noted that the middle section 41 of the notch wire 4 can be made of a metallic material. Specifically, it can be at least one of stainless steel, titanium alloy, and nitinol; the first transition section 42 and the second transition section 43 can be metallic or polymeric materials. Specifically, they can be nitinol, silicone rubber, natural rubber, and thermoplastic elastomers such as polyethylene and acrylate elastomer.
[0032] The notch wire 4 can be made of the same material with different hardness and elasticity in different sections, or can be composed of multiple materials with different hardness and elasticity connected together.
[0033] Furthermore, the radial cross-section of the middle section 41 is circular, triangular, quadrilateral, or irregular polygon, and its equivalent diameter size is 0.15 mm - 0.5 mm.
[0034] Preferably, the radial cross-section of the middle section 41 is circular. The notch wire 4 provided by this solution has a relatively smooth outer contour and is not likely to cause additional damage to the lesion site.
[0035] Furthermore, the radial cross-section of the first transition section 42 and the second transition section 43 is circular or oval, and its equivalent diameter size is 0.1 mm - 0.3 mm.
[0036] The middle section 41 and the first transition section 42, the second transition section 43 can have the same cross-section design, or can have different cross-section designs.
[0037] Preferably, the cross-section shapes of the middle section 41 and the first transition section 42, the second transition section 43 are different. The equivalent diameter of the middle section 41 is greater than or equal to the equivalent diameters of the first transition section 42 and the second transition section 43.
[0038] In a specific embodiment of the present invention, the cross-section of the middle section 41 is circular, and its equivalent diameter is 1.5 mm; the radial cross-sections of the first transition section 42 and the second transition section 43 are oval, and the equivalent diameter is 1.2 mm.
[0039] In a preferred embodiment of the present invention, when the balloon 3 is in the contracted and wound state, the notch wire 4 is in the natural state. At this time, the length of the notch wire 4 is the same as the axial length of the balloon 3 after contraction and winding, and the length of the middle section 41 of the notch wire 4 is the same as the length of the middle part 31 of the balloon 3; when the balloon 3 is inflated, the first transition section 42 and the second transition section 43 undergo elastic deformation, and their lengths extend to be the same as the lengths of the first transition part 32 and the second transition part 33 respectively.
[0040] According to the types of materials actually used, the design requirements for hardness / elasticity, and the application scenarios, the differences in tensile strength and elastic modulus can be achieved by, but not limited to, the following process methods:
[0041] 1) Heat treatment: By adjusting the temperature and cooling rate, the microstructure of the material can be changed, thereby obtaining different hardness and elasticity in different regions. For example, by performing directional quenching on a metal wire, the middle section 41 can have high hardness, while the first transition section 42 and the second transition section 43 can obtain high elasticity at a lower quenching temperature or a slower cooling rate.
[0042] 2) Controlled mechanical treatment: For example, by local cold working or hot working, the hardness and elasticity of the material can be changed. Local cold working can increase the hardness of the material, while local annealing can restore the original elasticity of the material.
[0043] 3) Material filling or reinforcement: Introducing different fillers or reinforcing fibers during the preparation of the notched wire 4 can change its hardness and elasticity. For example, carbon fibers or glass fibers can be locally embedded in the guide wire to increase the hardness of specific regions.
[0044] 4) Surface treatment: For example, depositing a hard layer on the surface of the guide wire by electroplating, physical vapor deposition (PVD), or chemical vapor deposition (CVD) can increase its hardness. By selecting different deposition materials and parameters, different hardness and elasticity can be obtained in different regions.
[0045] 5) Gradient material design: By special manufacturing techniques, such as coextrusion, interlayer blending, or rotational molding, gradient changes in hardness and elasticity can be achieved in a continuous object.
[0046] The middle section 41, the first transition section 42, and the second transition section 43 can be integrally formed, or can be prepared by bonding, mechanical connection, or welding. According to the types of materials actually used, the design requirements for hardness / elasticity, and the application scenarios, the preparation of the notched wire 4 can be achieved by, but not limited to, the following process methods:
[0047] 1) Bonding: Using specific adhesives, such as epoxy resin or polyurethane adhesives, to firmly bond two different materials together. Selecting a suitable adhesive can ensure the firmness and durability of the connection.
[0048] 2) Mechanical connection: This can include threaded connection, riveting, or other forms of mechanical fastening methods. For example, the high-hardness material at one end can be designed to have threads, while the low-hardness material at the other end can be designed to have corresponding threads, so that the two can be screwed together.
[0049] 3) Welding: For metallic materials, traditional welding techniques such as TIG welding, laser welding or arc welding can be used. For certain non-metallic materials, such as plastics, hot plate welding, ultrasonic welding or radio frequency welding can be used.
[0050] 4) Co-molding: Two materials can be injection molded continuously or step by step in a single mold, enabling changes in hardness and elasticity to be achieved in a continuous structure.
[0051] 5) Dual-material co-extrusion: Two different materials can be joined together in a continuous process through a co-extrusion process to form a two-layer or multi-layer structure.
[0052] 6) Plug-in connection: The ends of high-hardness materials and low-hardness materials can be designed to fit together so that they can be simply plugged together.
[0053] The following further elaborates on the above-mentioned intrinsically tapered wire-scribed balloon catheter through specific examples and comparative examples.
[0054] Example 1
[0055] A scriber balloon catheter, comprising a proximal tube 1, a distal tube 2, a balloon 3 and a scriber wire 4, wherein the balloon 3 comprises a middle portion 31, a first transition portion 32 and a second transition portion 33. When inflated, the length of the balloon 3 is 20 mm, wherein the length of the middle portion 31 is 16 mm, and the axial lengths of the first transition portion 32 and the second transition portion 33 are each 2 mm, and the diameter of the middle portion is 3 mm; the scriber wire 4 is a wire material with a circular radial cross-section bonded by a middle section 41, a first transition section 42 and a second transition section 43. The middle section 41 is made of stainless steel material, with a tensile strength of 1000 MPa and an elastic modulus of 200 GPa; the first transition section 42 and the second transition section 43 are made of ethylene propylene rubber, with a tensile strength of 20 MPa and an elastic modulus of 2 GPa.
[0056] The balloon is inflated to a nominal pressure of 12 atm and held for 30 s, and the balloon shape is stable; the balloon is deflated and contracted, and it can be measured that the length of the scriber wire has not changed.
[0057] Comparative Example 1
[0058] The difference between the scriber balloon catheter provided in this comparative example and the scriber balloon catheter provided in Example 1 is that the scriber wire is made of stainless steel material, with an overall tensile strength of 1000 MPa and an elastic modulus of 200 GPa.
[0059] The balloon is inflated to a nominal pressure of 12 atm and held for 30 s, and the balloon shape is stable. The balloon is deflated and contracted, and it can be measured that the scriber wire has a permanent deformation of 0.8 mm.
[0060] Comparative Example 2
[0061] The difference between the notched balloon catheter provided in this comparative example and the notched balloon catheter provided in Example 1 is that the notched wire is made of ethylene propylene rubber, with a tensile strength of 20 MPa and an elastic modulus of 2 GPa.
[0062] When the balloon is inflated to a nominal pressure of 12 atm and maintained for 30 s, it can be observed that during the balloon inflation process, the notched wire exerts pressure on the outer wall of the balloon and embeds into the balloon, making it difficult to produce a cutting effect; when the balloon is deflated and contracted, it can be measured that the length of the notched wire has not changed.
[0063] Comparing the experimental results of the examples and comparative examples provided by the present invention, it can be clearly seen that the notched balloon catheter provided by the present invention can ensure the cutting effect while maintaining good resilience of the notched wire.
[0064] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims
1. A notched balloon catheter, comprising a proximal tube (1), a distal tube (2), a balloon (3) with two ends hermetically connected to the proximal tube (1) and the distal tube (2) respectively, and a notched wire (4) axially attached to the outer wall of the balloon (3). The balloon (3) includes an intermediate portion (31), a first transition portion (32) and a second transition portion (33) respectively connected to both ends of the intermediate portion (31). When the balloon (3) is in a fully inflated state, the intermediate portion (31) has substantially the same radial dimension along the axis. The radial dimension of the first transition portion (32) gradually decreases from the distal end to the proximal end and is hermetically connected to the proximal tube (1). The radial dimension of the second transition portion (33) gradually decreases from the proximal end to the distal end and is hermetically connected to the distal tube (2). It is characterized in that The notched wire (4) includes an intermediate section (41), a first transition section (42) and a second transition section (43) respectively connected to both ends of the intermediate section (41). The proximal end of the first transition section (42) is fixedly connected to the proximal tube (1). The distal end of the second transition section (43) is fixedly connected to the distal tube (2). The tensile strength and elastic modulus of the intermediate section (41) are greater than those of the first transition section (42) and the second transition section (43). When the balloon (3) is in a contracted and wound state, the notched wire (4) is axially closely attached to the outside of the contracted and wound balloon (3) or is wrapped by the contracted and wound balloon (3). When the balloon (3) is in a fully inflated state, the intermediate section (41) is axially attached to the outer wall of the intermediate portion (31). The first transition section (42) undergoes elastic deformation and is attached to the outer wall of the first transition portion (32). The second transition section (43) undergoes elastic deformation and is attached to the outer wall of the second transition portion (33).
2. The notched balloon catheter according to claim 1, wherein The tensile strength of the intermediate section (41) is 700 MPa - 1200 MPa, and the elastic modulus is 80 GPa - 240 GPa. The tensile strength of the first transition section (42) and the second transition section (43) is 1 MPa - 80 MPa, and the elastic modulus is 0.01 GPa - 4 GPa.
3. The notched balloon catheter according to claim 2, wherein The tensile strength and elastic modulus of the first transition section (42) gradually decrease from the distal end to the proximal end. The tensile strength and elastic modulus of the second transition section (43) gradually decrease from the proximal end to the distal end.
4. The notched balloon catheter according to claim 2, wherein, The intermediate section (41) is made of a metallic material. The first transition section (42) and the second transition section (43) are made of a metallic or polymeric material.
5. The notched balloon catheter according to claim 4, wherein The intermediate section (41) is made of at least one material selected from stainless steel, titanium alloy, and nitinol alloy. The first transition section (42) and the second transition section (43) are made of nitinol alloy material, or made of at least one material selected from silicone rubber, thermoplastic elastomer, polyethylene, acrylate elastomer, and natural rubber.
6. The notched balloon catheter according to any one of claims 1-5, characterized in that The radial cross-section of the intermediate section (41) of the notched wire is circular, triangular, quadrilateral, or irregular polygon. The equivalent diameter range of the intermediate section (41) is 0.15 mm - 0.5 mm. The radial cross-sections of the first transition section (42) and the second transition section (43) are circular or elliptical, and the equivalent diameters of the first transition section (42) and the second transition section (43) range from 0.1 mm to 0.3 mm.
7. The scored balloon catheter according to claim 6, wherein The equivalent diameter of the middle section (41) is greater than or equal to the equivalent diameters of the first transition section (42) and the second transition section (43).
8. A preparation process of a notched balloon catheter, characterized in that, Comprising the following steps: Providing a balloon catheter, the balloon catheter comprising a proximal tube (1), a distal tube (2), and a balloon (3) hermetically connected between the proximal tube (1) and the distal tube (2), the balloon (3) comprising a middle portion (31) and a first transition portion (32) and a second transition portion (33) respectively connected to both ends of the middle portion (31); Providing a scoring wire (4), the scoring wire (4) comprising a middle section (41) and a first transition section (42) and a second transition section (43) respectively connected to both ends of the middle section (41), the tensile strength of the middle section being 700 MPa - 1200 MPa and the elastic modulus being 80 GPa - 240 GPa; the tensile strength of the first transition section (42) and the second transition section (43) being 1 MPa - 80 MPa and the elastic modulus being 0.01 GPa - 4 GPa, the length of the scoring wire (4) in the natural state being the same as the length of the balloon (3) when it is shrunk and wound, the length of the middle section (41) being the same as the axial length of the middle portion (31), when the balloon (3) is inflated, the length of the first transition section (42) after elastic deformation being the same as the side wall length of the first transition portion (32), and the length of the second transition section (43) after elastic deformation being the same as the side wall length of the second transition portion (33); Fixing and connecting both ends of the scoring wire (4) to the proximal tube (1) and the distal tube (2) respectively.
9. The preparation process of the notched balloon catheter according to claim 8, characterized in that, The preparation steps of the scoring wire are as follows: Providing a metal wire, and through a heat treatment process, making the tensile strength of the middle section of the metal wire reach 700 MPa - 1200 MPa and the elastic modulus reach 80 GPa - 240 GPa; making the tensile strength of the two end sections of the middle section reach 1 MPa - 80 MPa and the elastic modulus reach 0.01 GPa - 4 GPa to obtain the scoring wire.
10. The preparation process of the notched balloon catheter according to claim 8, characterized in that, The preparation steps of the scoring wire are as follows: Providing a metal wire and two polymer wires, the length of the metal wire being the same as the length of the middle portion (31) of the balloon, the tensile strength of the metal wire being 700 MPa - 1200 MPa and the elastic modulus being 80 GPa - 240 GPa, the tensile strength of the two polymer wires being 1 MPa - 80 MPa and the elastic modulus being 0.01 GPa - 4 GPa; bonding the two polymer wires to both ends of the metal wire respectively to obtain the scoring wire.