Cutting balloon dilatation catheter

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to a cutting balloon dilatation catheter which comprises a balloon, a catheter assembly communicated with the near end of the balloon and an inner tube arranged in the balloon and the catheter assembly in a penetrating mode. An elastic cutting assembly is arranged on the periphery of the balloon, and a knife-shaped cutting structure is arranged on the side, away from the balloon, of the elastic cutting assembly. The balloon comprises conical sections located at the two ends and a cylindrical section connected between the two conical sections, and the elastic cutting assembly is at least separated from the cylindrical section of the balloon; after the balloon is decompressed and contracted, the elastic cutting assembly retracts to be in a pipe cavity state under the elastic effect of the elastic cutting assembly. According to the cutting balloon dilatation catheter, the elastic cutting assembly is designed to be of a structure separated from the balloon, self-retraction of the elastic cutting assembly is achieved, the balloon has the excellent retracing property, damage to the blood vessel wall or excessive dilatation can be reduced through the excellent retracing property, and the operation safety performance is improved.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically a cutting balloon dilation catheter. Background Technology

[0002] Percutaneous endovascular angioplasty (PTA) involves percutaneously puncturing a blood vessel and inserting a balloon dilatation catheter through a guiding catheter to dilate the diseased vessel and improve blood flow at the narrowed site. In some calcified or fibrotic vascular lesions, conventional balloon dilatation catheters are often insufficient to restore blood flow and result in a high stenosis rate. Clinically, for these lesions, a cutting balloon is typically used for dilation. A cutting blade or wire mounted on the balloon surface cuts the vessel wall, improving blood flow and reducing stenosis.

[0003] Currently used cutting balloons on the market have poor retrieval properties. After depressurization, poor retrieval can easily damage the vessel wall, especially cutting balloons with blades, which pose a greater risk of injury. Furthermore, their poor permeability makes it difficult to reach calcified lesions in tortuous vessels. Existing cutting balloon structures generally consist of sharp blades bonded to the balloon surface. The retrieval property relies solely on the vacuum created by depressurization to pull the blades back. The blades do not generate retrieval force during this process, and the folding process after the blades are bonded to the balloon surface further affects retrieval (the retrieval property is influenced by the folding process). Therefore, their retrieval properties are poor. Additionally, the UV-cured adhesive bonded to the surface of existing cutting balloons further reduces their permeability, making it difficult to safely and effectively cut and dilate lesions in distal tortuous vessels due to the difficulty in reaching the lesion site. Another type of restraint balloon works by creating regular protrusions on the surface of the balloon through restraint wires. The lesion is expanded through the protruding balloon parts. However, this structure is not a cutting balloon. The restraint wires only serve to restrain the balloon and do not cut the lesion.

[0004] Therefore, there is a clinical need for a cutting balloon with excellent embracing properties that can successfully reach the location of tortuous calcified lesions to address the dilation of calcified lesions in tortuous blood vessels, while avoiding damage to the blood vessels from the cutting blade. Utility Model Content

[0005] To address the problems mentioned above, this invention provides a cutting balloon dilation catheter. By incorporating an elastic cutting component, after the balloon is depressurized and contracted, the elastic cutting component retracts into a tubular shape under its own elasticity, thereby improving the balloon's susceptibility and passage.

[0006] The present invention adopts the following technical solution:

[0007] A cutting balloon dilation catheter includes a balloon, a catheter assembly communicating with the proximal end of the balloon, and an inner tube passing through the balloon and the catheter assembly;

[0008] The outer periphery of the balloon is provided with an elastic cutting component, and the side of the elastic cutting component opposite to the balloon is provided with a knife-shaped cutting structure; the balloon includes conical segments at both ends and a cylindrical segment connecting the two conical segments, and the elastic cutting component is at least separately disposed from the cylindrical segment of the balloon;

[0009] After the balloon is depressurized and contracted, the elastic cutting component retracts into a tubular shape under its own elasticity.

[0010] Furthermore, the flexible cutting components are made of ultra-elastic metallic materials or polymer materials.

[0011] Furthermore, the elastic cutting component includes at least two axially spaced connecting rings, the connecting rings being a wave-shaped closed structure with alternating crests and troughs, and the connecting rings being disposed on the cylindrical section of the balloon.

[0012] The flexible cutting assembly also includes a cutting section connected between at least one set of two adjacent connecting rings, with a blade-shaped cutting structure formed on the cutting section.

[0013] Furthermore, the crests of the two connecting rings are aligned with crests, and the troughs with troughs; straight sections connect opposite crests and troughs, and multiple axially parallel straight sections form a cutting section; or

[0014] The crests of the two connecting rings are paired with the troughs, and the troughs are paired with the crests; straight sections connect the opposite crests and troughs, and multiple straight sections that are parallel to each other in the axial direction form the cutting section.

[0015] Furthermore, multiple spiral segments are formed between the two connecting rings, and these spiral segments form a cutting section.

[0016] Furthermore, the blade-shaped cutting structure is integrally formed with the cutting part, or the blade-shaped cutting structure is separately formed with the cutting part, and the blade-shaped cutting structure is fixedly installed on the cutting part.

[0017] Furthermore, the blade-shaped cutting structure includes several cutting blades formed on the cutting section.

[0018] Furthermore, the catheter assembly includes a catheter hub, a stress-relieving tube, a proximal outer tube, and a distal outer tube;

[0019] The stress-relieving tube is connected between the catheter hub and the proximal outer tube, and the distal outer tube is connected between the proximal outer tube and the balloon. The distal outer tube is an elastic tube.

[0020] One end of the balloon and one end of the elastic cutting assembly are both welded to the distal outer tube.

[0021] Furthermore, the distal end of the inner tube passes through the balloon and connects to the head end, which is made of soft material and has a conical structure with a smooth transition between the small diameter end of the head end and its side.

[0022] The other end of the balloon and the other end of the elastic cutting assembly are both welded to the inner tube.

[0023] Furthermore, the inner tube includes an inner layer, an intermediate reinforcing layer, and an outer polymer layer, wherein the inner layer is made of one or more of high-density polyethylene, polytetrafluoroethylene, and polyimide.

[0024] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0025] (1) The cutting balloon dilation catheter of this utility model includes an elastic cutting component disposed on the periphery of the balloon, and the elastic cutting component is at least separately disposed from the cylindrical section of the balloon. After the balloon is depressurized and contracted, the elastic cutting component retracts into a lumen shape under its own elasticity, giving the balloon excellent recoil resistance. Excellent recoil resistance can reduce damage to the blood vessel wall or over-dilation, and improve the safety of the operation. At the same time, compared with the cutting balloon where the blade is glued to the surface of the balloon, the separate structure and the elasticity of the elastic cutting component itself can also improve the balloon's permeability.

[0026] (2) The elastic cutting component of the cutting balloon dilation catheter of this utility model is made of super-elastic metal material, which is more beneficial to the contraction and retraction of the balloon.

[0027] (3) The elastic cutting component of the cutting balloon dilation catheter of this utility model includes a connecting ring and a cutting part. The connecting ring is a wave-shaped closed structure with alternating peaks and troughs, and the connecting ring is set on the cylindrical section of the balloon. The wave-shaped connecting ring structure makes the balloon easier to contract and retract.

[0028] (4) The cutting balloon dilation catheter of this invention maintains the excellent permeability of balloon dilation catheters, ensuring that the balloon dilation catheter can smoothly reach the lesion location. At the same time, by setting a blade-shaped cutting structure on the cutting part, the balloon has the ability to cut the lesion. When the balloon is opened, its elastic cutting component is expanded, the blade-shaped cutting structure is stretched, and calcified and fibrotic blood vessels are cut, ensuring the lesion dilation effect, improving the success rate of blood flow restoration, and reducing the occurrence of stenosis. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This is an overall structural diagram of a balloon cutting catheter provided in an embodiment of the present invention;

[0031] Figure 2 This is an overall structural diagram of a balloon cutting catheter provided in another embodiment of the present invention;

[0032] Figure 3 for Figure 1 Enlarged view of part A in the image;

[0033] Figure 4 An assembly structure diagram of a balloon and an elastic cutting assembly provided in an embodiment of the present invention;

[0034] Figure 5 An assembly structure diagram of a balloon and an elastic cutting assembly provided for another embodiment of the present invention;

[0035] Figure 6 A structural plan view of an elastic cutting component provided in an embodiment of this utility model;

[0036] Figure 7 A structural plan view of an elastic cutting component provided in another embodiment of this utility model;

[0037] Figure 8 for Figure 6 Enlarged view of the BB section in the image;

[0038] Figure 9 for Figure 7 Enlarged view of the CC section in the image;

[0039] Figure 10 for Figure 6 and Figure 7 Enlarged view of the DD section in the image;

[0040] Figure 11 A schematic diagram (a) showing the distribution of the blade-shaped cutting structure provided in an embodiment of this application;

[0041] Figure 12 A schematic diagram (II) showing the distribution of the blade-shaped cutting structure provided in one embodiment of this application;

[0042] Figure 13 A schematic diagram (III) showing the distribution of the blade-shaped cutting structure provided in an embodiment of this application;

[0043] Wherein: 1-balloon, 11-conical segment, 12-cylindrical segment, 2-catheter assembly, 21-catheter seat, 22-stress relief tube, 23-proximal outer tube, 24-distal outer tube, 25-head end, 3-inner tube, 4-elastic cutting assembly, 41-knife-shaped cutting structure, 411-cutting blade, 42-connecting ring, 43-cutting part, 431-straight segment, 432-rectangular shape. Detailed Implementation

[0044] The technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0045] The following is in conjunction with the appendix Figure 1 To be continued Figure 13 The present invention will be described in detail with specific embodiments.

[0046] like Figure 1-13 As shown, this utility model provides a cutting balloon dilation catheter, including a balloon 1, a catheter assembly 2 communicating with the proximal end of the balloon 1, and an inner tube 3 passing through the balloon and the catheter assembly 2;

[0047] An elastic cutting component 4 is provided on the outer periphery of the balloon 1. A blade-shaped cutting structure 41 is provided on the side of the elastic cutting component 4 facing away from the balloon 1. The balloon 1 includes conical segments 11 at both ends and a cylindrical segment 12 connecting the two conical segments 11. Typically, the conical segments 11 do not participate in the expansion and cutting of blood vessels, while the cylindrical segment 12 contacts the blood vessel during expansion and participates in the work; therefore, it can be called the working segment. The elastic cutting component 4 is at least separated from the cylindrical segment 12 of the balloon 1. That is, in the working segment of the balloon 1, the elastic cutting component 4 and the balloon 1 are in a separate state. They can be spaced apart or in contact, but they are independent, not fixed, and have no connection. Of course, the balloon can also be separated from the elastic cutting component 4 in the conical segment 11, but this is not limited. The elastic cutting component 4 of this application has a certain elasticity. After the balloon 1 is depressurized and contracted, the elastic cutting component 4 retracts into a lumen shape under its own elastic action, enveloping the balloon 1. This can be understood as follows: when balloon 1 inflates, it causes the elastic cutting component 4 to expand, creating stress concentration at the elastic cutting component 4, thereby effectively cutting the lesion area. When balloon 1 is depressurized, the elastic cutting component 4 contracts under its own elasticity, and the degree of contraction is no less than that of balloon 1. After contraction, it can wrap around balloon 1, giving the cutting balloon catheter of this application excellent embracing properties. Excellent embracing properties can reduce damage to the blood vessel wall or over-expansion, improving surgical safety. At the same time, compared with cutting balloons where the blade is glued to the surface of the balloon, the separate structure and the elasticity of the elastic cutting component 4 itself can also improve the permeability of the balloon catheter. Permeability refers to the ability of the balloon catheter to pass through narrow or tortuous blood vessels. Good permeability means that the catheter can easily reach the calcified lesion site of tortuous blood vessels.

[0048] It should be noted that, in this application, the term "distal" refers to the end of the cutting balloon dilation catheter inserted into the blood vessel, that is, the end closer to the site of treatment; "proximal" refers to the end of the cutting balloon dilation catheter closer to the operator.

[0049] This invention's cutting balloon catheter maintains the excellent permeability of a balloon dilation catheter, ensuring that the balloon dilation catheter can smoothly reach the lesion location. Simultaneously, by providing a blade-shaped cutting structure 41 on the cutting section 43, the balloon 1 possesses the ability to cut the lesion. When the balloon 1 is opened, its elastic cutting component 4 expands, opening the blade-shaped cutting structure 41 to cut calcified and fibrotic blood vessels, ensuring effective lesion dilation, improving the success rate of blood flow restoration, and reducing the occurrence of vascular stenosis.

[0050] Specifically, the elastic cutting component is made of a superelastic metal material or a polymer material. Using a superelastic metal material is more beneficial for balloon contraction and recoil; good recoil reduces the risk of damage to the blood vessel wall. Since the elastic cutting component of this application also has a blade-shaped cutting structure, poor recoil would cause greater damage to the blood vessel. This application utilizes the excellent recoil of the elastic cutting component to minimize the shrinkage of the blade-shaped cutting structure after balloon depressurization, thus improving balloon passage. Of course, using a polymer material also gives the elastic cutting component good resilience and passage, which will not be elaborated upon here.

[0051] In addition, the balloon material of this application is also made of polymer material, which can be folded into a tubular shape through a folding process, so that the elastic cutting component 4 can be fitted on the surface of the balloon 1. After inflation, the balloon 1 expands and has good non-compliance so that the balloon 1 will not produce a dog bone effect when expanding the lesion.

[0052] For details, please refer to Figures 4 to 7 The elastic cutting component 4 includes at least two axially spaced connecting rings 42. Each connecting ring 42 is a wave-shaped closed structure with alternating crests and troughs, and is disposed on the cylindrical segment 12 of the balloon 1. The elastic cutting component 4 also includes a cutting section 43 connected between at least one set of adjacent connecting rings 42. A blade-shaped cutting structure 41 is formed on the cutting section 43. The connecting rings 42, when the balloon 1 transitions from an inflated state to a contracted state, provide better circumferential support due to their dense arrangement. The cutting section 43 consists of multiple straight segments 431 or spiral segments, or a combination of straight segments 431 and spiral segments, connected to adjacent connecting rings 42. Specifically, in this embodiment, there are two connecting rings 42, respectively disposed at both ends of the cylindrical segment 12 of the balloon 1. The cutting section 43 is disposed between the two connecting rings 42 and serves to support the blade-shaped cutting structure 41. This application does not limit the specific shape of the cutting section 43 and the blade-shaped cutting structure 41, nor the density of the blade-shaped cutting structure 41; those skilled in the art can design them according to actual usage requirements.

[0053] See Figure 4In some embodiments, the peaks of the two connecting rings 42 are aligned with each other, and the troughs with each other. Straight sections 431 connect opposite peaks and troughs, and multiple axially parallel straight sections 431 form a cutting section 43. Each straight section 431 is provided with a knife-shaped cutting structure 41. Typically, three or four straight sections 431 are provided, but this is not limited to these; the specific number can be set according to the requirements of the wrapping effect. It is understood that the knife-shaped cutting structures 41 should not be too densely packed in the circumferential direction. Therefore, in other embodiments, a portion of the straight sections 431 of the cutting section 43 are provided with knife-shaped cutting structures 41, while another portion of the straight sections 431 are not provided with knife-shaped cutting structures 41. The straight sections 431 without knife-shaped cutting structures 41 are used to improve the overall wrapping effect of the elastic cutting assembly 4.

[0054] See Figure 5 In some embodiments, the crests of the two connecting rings 42 are aligned with the troughs, and the troughs with the crests; a straight section 431 connects the opposing crests and troughs, and multiple axially parallel straight sections 431 form the cutting section 43. Similarly, each straight section 431 is provided with a knife-shaped cutting structure 41. Typically, three or four straight sections 431 are provided, but this is not limited to them, and the specific number can be set according to the requirements of the retaining property. It is known that the knife-shaped cutting structures 41 should not be too dense in the circumferential direction. Therefore, in other embodiments, a portion of the straight sections 431 of the cutting section 43 are provided with knife-shaped cutting structures 41, while another portion of the straight sections 431 are not provided with knife-shaped cutting structures 41. The straight sections 431 without knife-shaped cutting structures 41 are used to improve the overall retaining property of the elastic cutting assembly 4.

[0055] In some embodiments, multiple helical segments are formed between the two connecting rings 42, forming a cutting section 43. The helical cutting section 43 causes the blade-shaped cutting structure 41 to also be arranged in a helical shape, which increases the cutting friction when the balloon 1 expands, preventing the balloon from slipping. Similarly, in other embodiments, a portion of the helical segments of the cutting section 43 are provided with blade-shaped cutting structures 41, while another portion of the helical segments are not provided with blade-shaped cutting structures 41. The helical segments without blade-shaped cutting structures 41 are used to improve the overall resilience of the elastic cutting assembly 4.

[0056] For details, please refer to Figure 6 , Figure 8 and Figure 10 In some embodiments, the blade-shaped cutting structure 41 is integrally formed with the cutting part 43, that is, the cutting part 43 is specially processed into a cross-section with a sharp blade shape, while the cross-section of the remaining part of the elastic cutting component 4 is rectangular 432, which does not have a cutting function; see reference Figure 7 , Figure 9 and Figure 10In some embodiments, the blade-shaped cutting structure 41 and the cutting part 43 are separately arranged, and the blade-shaped cutting structure 41 is fixedly installed on the cutting part 43. That is, the cross-sections of the cutting part 43 and the connecting ring 42 are all rectangular 432. The rectangular 432 does not have a cutting function, while the blade-shaped cutting structure 41 is embedded or welded to the cutting part 43 as a separate component. It should be noted that although the combination of the blade-shaped cutting structure 41 and the cutting part 43 is different, the effect achieved is basically the same. Those skilled in the art can choose according to the complexity of the manufacturing process. This application does not make specific limitations. In addition, the rectangular 432 in this application is formed by a rounded transition to avoid sharp parts that may damage blood vessels.

[0057] For further details, please refer to [link / reference]. Figure 11 , Figure 12 and Figure 13 The blade-shaped cutting structure 41 includes a plurality of cutting blades 411 formed on the cutting section 43. The following description uses an example where the cutting section 43 consists of straight segments 431, each of which has a plurality of cutting blades 411 distributed on it. These cutting blades 411 are arranged alternately vertically or at a certain angle along the width of the straight segment 431. The length of the cutting blades 411 can vary. The dispersed arrangement of the cutting blades 411 results in a larger cutting area and better cutting effect. Furthermore, the alternating arrangement of the cutting blades 411 increases the cutting friction during the expansion of hard calcified lesions, preventing the balloon 1 from slipping. Of course, in other embodiments, the cutting blades 411 on the cutting section 43 can also be irregularly distributed; any method that achieves the effect of lesion expansion falls within the scope of protection of this application.

[0058] Specifically, in this embodiment, see [reference] Figure 1 and Figure 2The catheter assembly 2 includes a catheter hub 21, a stress-relieving tube 22, a proximal outer tube 23, and a distal outer tube 24. The stress-relieving tube 21 connects the catheter hub 21 and the proximal outer tube 23, and the distal outer tube 24 connects the proximal outer tube 23 and the balloon 1. The distal outer tube 24 is an elastic tube. One end of the balloon 1 and one end of the elastic cutting assembly 4 are welded to the distal outer tube 24. The catheter hub 21 and the stress-relieving tube 22 are firmly connected mainly by UV adhesive or thermosetting adhesive. In terms of material selection, the catheter hub 21 tends to use rigid polycarbonate or polyurethane. Polycarbonate has excellent mechanical strength, impact resistance, and high transparency. Polyurethane is known for its good wear resistance and flexibility. Both meet the high standards required for materials in medical devices, giving the catheter hub 21 durable and easy-to-sterilize properties, ensuring its long-term reliable use in the medical environment. The purpose of the stress-relieving tube 22 is to prevent stress concentration during operation from causing breakage or kinking at the connection between the catheter seat 21 and the proximal outer tube 23. The stress-relieving tube 22 is usually made of a soft elastomer material, such as polyurethane elastomer, polyolefin, or polyethylene elastomer. The proximal outer tube 23 is used to provide an inflation channel for the balloon, while also providing catheter pushing energy and support. Commonly used proximal outer tubes 23 are made of metal or polymer materials, or a combination of metal and polymer materials.

[0059] It should be noted that the cutting balloon dilation catheter of this application includes two structures: one is an OTW structure balloon catheter, in which the guidewire enters from the catheter seat 21; the other is an RX structure balloon catheter, in which an RX port is provided on the proximal outer tube 23, and the guidewire enters through the RX port.

[0060] Furthermore, the distal end of the inner tube 3 passes through the balloon 1 and connects to the tip 25. The tip 25 is made of a soft material and has a conical structure with a smooth transition between its small-diameter end and its sides. The other end of the balloon 1 and the other end of the elastic cutting component 4 are both welded to the inner tube 3. The tip 25 is made of a high-quality soft material, such as polyurethane or polyamide, combined with a smooth and streamlined design of the small-diameter end. This not only ensures that the catheter is gentle and undamaged when traversing the vascular network, avoiding any potential damage to the fragile blood vessel walls, but also allows it to move freely through tortuous and complex vascular pathways, thereby ensuring the safety and effectiveness of the procedure.

[0061] Preferably, the inner tube 3 includes an inner layer, a middle reinforcing layer, and an outer polymer layer. The inner layer is made of one or more of high-density polyethylene, polytetrafluoroethylene, and polyimide. High-density polyethylene, polytetrafluoroethylene, and polyimide are all materials with low coefficients of friction, which facilitates the passage of the guide wire.

[0062] The working process of the cutting balloon catheter in this application is as follows: the pressure pump is connected to the catheter seat 21 to pressurize the catheter. After pressurization, the balloon 1 will expand, which will drive the elastic cutting component 4 to expand and treat the lesion. After the pressure is released, the elastic cutting component 4 will retract through its own elasticity and wrap around the surface of the balloon 1 to form a tubular structure. Then the catheter is withdrawn.

[0063] The present invention has been further described above with reference to specific embodiments. However, it should be understood that the specific description herein should not be construed as limiting the substance and scope of the present invention. Various modifications made by those skilled in the art to the above embodiments after reading this specification are all within the scope of protection of the present invention.

Claims

1. A cutting balloon dilation catheter, characterized by, The balloon, a catheter assembly in communication with a proximal end of the balloon, and an inner tube disposed in the balloon and the catheter assembly; The balloon is provided with an elastic cutting assembly on the outer periphery, and a knife-shaped cutting structure is arranged on the side of the elastic cutting assembly away from the balloon; the balloon comprises a conical section at each end and a cylindrical section connected between the two conical sections, and the elastic cutting assembly is arranged separately from at least the cylindrical section of the balloon; After the balloon is deflated, the elastic cutting assembly is retracted into a lumen shape under the elastic action of itself.

2. The cutting balloon catheter of claim 1, wherein, The elastic cutting assembly is made of a super-elastic metal material or a high polymer material.

3. The cutting balloon catheter of claim 1, wherein, The elastic cutting assembly comprises at least two axially spaced connecting rings, the connecting rings are in a wave-shaped closed structure with alternating peaks and valleys, and the connecting rings are arranged on the cylindrical section of the balloon. The elastic cutting assembly further comprises a cutting part connected between at least two adjacent connecting rings, and the knife-shaped cutting structure is formed on the cutting part.

4. The cutting balloon catheter of claim 3, wherein, The peaks of two connecting rings are connected to each other, and the valleys of two connecting rings are connected to each other; straight sections are connected between opposite peaks and valleys, and a plurality of axially parallel straight sections form the cutting part. Or The peaks of two connecting rings are connected to the valleys of two connecting rings, and the valleys of two connecting rings are connected to the peaks of two connecting rings; straight sections are connected between opposite peaks and valleys, and a plurality of axially parallel straight sections form the cutting part.

5. The cutting balloon catheter of claim 3, wherein, A plurality of spiral sections are formed between two connecting rings, and a plurality of spiral sections form the cutting part.

6. The cutting balloon catheter of claim 3, wherein, The knife-shaped cutting structure is integrally formed with the cutting part, or the knife-shaped cutting structure is separately arranged from the cutting part and fixedly installed on the cutting part.

7. The cutting balloon catheter of claim 3, wherein, The knife-shaped cutting structure comprises a plurality of cutting blades formed on the cutting part.

8. The cutting balloon catheter of claim 1, wherein, The catheter assembly comprises a catheter seat, a stress relief tube, a proximal outer tube, and a distal outer tube; The stress relief tube is connected between the catheter seat and the proximal outer tube, the distal outer tube is connected between the proximal outer tube and the balloon, and the distal outer tube is an elastic tube; One end of the balloon and one end of the elastic cutting assembly are welded on the distal outer tube.

9. The cutting balloon catheter of claim 8, wherein, The distal end of the inner tube is connected with a head after passing through the balloon, the head is made of soft material, and the head is in a conical structure, and the small-diameter end of the head is smoothly connected to the side surface thereof; The other end of the balloon and the other end of the elastic cutting assembly are welded on the inner tube.

10. The cutting balloon catheter of claim 1, wherein, The inner tube comprises an inner layer, a middle reinforcing layer, and an outer polymer layer, and the inner layer is made of one or more of high-density polyethylene, polytetrafluoroethylene, and polyimide.

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