Nicking balloon catheter

Abstract

The utility model provides a nick wire and a nick balloon catheter. The section, perpendicular to the axial direction of the nick wire, of the nick wire is similar to a pentagon, the degree of scratching the balloon body can be effectively reduced, and therefore failure caused by scratching or puncturing of the balloon is avoided. The nick balloon catheter provided by the utility model comprises a balloon body which is connected to the far end of the catheter assembly; the nicking assembly is arranged on the outer wall of the balloon body in a sleeving manner; the nicking assembly comprises at least one nicking wire. The nicking balloon catheter has high safety and reliability. When the bottom of the indentation wire is in the shape of the concave circular arc, the indentation wire can be better matched with the outer wall of the balloon body, so that the combination stability of the indentation wire and the balloon body is good, the indentation wire is not prone to being separated from the balloon body when the catheter is bent, and the passing ability and flexibility of the catheter are improved; and the occurrence rate that the catheter scratches the normal blood vessel wall in the conveying process can also be reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field, concretely relates to a score wire and score balloon catheter. BACKGROUND

[0002] Coronary artery stenosis refers to the deposition of lipid and other substances in the coronary intima, the proliferation of smooth muscle cells and the increase of collagen fibers, which leads to the thickening and hardening of the coronary artery wall, the narrowing of the vascular lumen and even the occlusion of the pathological changes, also known as coronary heart disease. When the coronary heart disease develops to a certain extent, the coronary artery stenosis gradually aggravates, which limits the blood flow into the myocardium, and the heart cannot get enough oxygen supply, resulting in chest discomfort and other symptoms. At present, drug eluting stent (DES) is still the dominant of angioplasty, and drug coated balloon (DCB) as a new and mature interventional therapy technology has been confirmed by many clinical trials in the efficacy and safety and effectiveness of in-stent restenosis (ISR), tubular arterial stenosis, small vessel lesions, bifurcation lesions and other aspects. However, whether it is simple DCB treatment or DES treatment, pretreatment is particularly important. The expansion of ordinary balloon leads to the compression, rupture and elastic expansion of plaque, which is easy to cause intimal tear and even acute occlusion, and the elastic retraction and proliferation reaction to the damage after that are also important causes of restenosis.

[0003] Scored balloon (also known as cutting balloon) can produce multiple straight and / or curved notches or cuts on the surface of the lesion site by cutting the treatment site, thereby providing a better operation window for the treatment of coronary artery stenosis, and reducing the tearing, elastic retraction and other problems that occur when ordinary balloon is used for pretreatment. However, there are still many problems in the scored balloon on the current market, for example, the overall passability of some scored balloon products is poor, which limits the ability of the balloon to enter the curved blood vessels or smaller blood vessels. The cutting knife of some scored balloon products has poor retraction characteristics, which is more likely to cause blood vessel damage during the retraction process, resulting in surgical complications and risks, and may even endanger life. The metal score wire of some scored balloon products is easy to partially detach from the outer surface of the balloon when passing through the bend, and the cutting unit metal wire detaches from the outer surface of the balloon, so it is easy to scratch the inner wall of the blood vessel, especially during transportation, when the cutting unit metal wire is in a sharp angle outward state, the normal blood vessel wall is easy to be scratched, which brings new risks. In addition, the edge of the score wire structure on some traditional scored balloon is relatively sharp in contact with the balloon, which has the risk of accidentally piercing the balloon during use, thereby causing the balloon to fail. SUMMARY

[0004] In view of the problems in the prior art, the utility model discloses a kind of score wire and score balloon catheter, provided score wire can reduce the possibility of scratching balloon body, and the combination stability with balloon body, improve the passability and compliance of catheter, reduce the incidence of scratch of normal blood vessel inner wall in the delivery process of score balloon.

[0005] The utility model discloses first aspect provides a kind of score wire, the cross section of the score wire in perpendicular to the axial direction of the score wire is pentagonal.

[0006] In some embodiments, the score wire includes a cutting portion and a base portion connected to the cutting portion, the base portion is disposed opposite to the cutting portion in a radial direction of the score wire;

[0007] The cross section of the cutting portion in perpendicular to the axial direction of the score wire is triangular, and the cross section of the base portion in perpendicular to the axial direction of the score wire includes a concave circular arc opposite to the triangular.

[0008] The utility model discloses second aspect provides a kind of score balloon catheter, comprising:

[0009] A catheter assembly;

[0010] A balloon body connected to a distal end of the catheter assembly;

[0011] A score assembly sleeved on an outer wall of the balloon body; the score assembly includes at least one score wire according to the first aspect.

[0012] In some embodiments, the score wire includes a cutting portion and a base portion connected to the cutting portion, the cutting portion is located on a side of the score wire away from the balloon body;

[0013] The cross section of the base portion of the score wire in perpendicular to the axial direction of the score wire has a concave circular arc shape, and when the balloon body is inflated, the circular arc shape cooperates with the outer wall of the balloon body.

[0014] In some embodiments, at least one of the score wires is spirally wound along an axial direction of the balloon body; and / or

[0015] At least one of the score wires is disposed along an axial direction parallel to the balloon body.

[0016] In some embodiments, the score assembly forms a structure having a central axis, and the central axis of the score assembly coincides with at least a portion of the central axis of the balloon body.

[0017] In some embodiments, the scoring assembly has a gap formed therein, the scoring balloon catheter has a folded state, in which the balloon body includes a plurality of lobes, and part of the lobes protrude out of the gap in a direction away from the central axis of the balloon body, the maximum distance from the outer surface of the lobes to the central axis of the balloon body is greater than or equal to the maximum height of the scoring wire from the central axis of the balloon body.

[0018] In some embodiments, the catheter assembly includes an inner tube and an outer tube, the outer tube is sleeved on the outer side of part of the inner tube, the distal end of the inner tube is arranged through the balloon body and connected with the distal end of the balloon body, and the proximal end of the balloon body is connected with the distal end of the outer tube.

[0019] In some embodiments, the scoring assembly further includes a connecting bracket and a connecting rod arranged at the distal end, and a connecting bracket and a connecting rod arranged at the proximal end, and the connecting brackets at the distal end and the proximal end are connected with the scoring wire through the corresponding connecting rods.

[0020] In some embodiments, the connecting bracket and / or the side of the connecting rod close to the balloon body is a concave arc structure.

[0021] In some embodiments, the connecting rod is parallel to the axial direction of the balloon body, and the side of the connecting rod close to the balloon body is in contact with the outer wall of the balloon body.

[0022] In some embodiments, the catheter assembly includes an outer tube and an elastic tube, the proximal end of the balloon body is connected with the distal end of the outer tube, the proximal end of the elastic tube is connected with the outer tube, the distal end of the elastic tube is connected with the proximal end of the connecting bracket, and the elastic tube is sleeved on the outer side of the outer tube, the connecting bracket at the proximal end and the connecting rod at the proximal end.

[0023] The cross section of the scoring wire perpendicular to the axial direction of the scoring wire is a pentagon, which can effectively reduce the degree of scratching the balloon body, thereby avoiding the failure of the balloon due to scratching or piercing. The scoring balloon catheter provided by the utility model includes a catheter assembly, a balloon body and a scoring assembly, wherein the balloon body is connected to the distal end of the catheter assembly; the scoring assembly is sleeved on the outer wall of the balloon body; the scoring assembly includes at least one scoring wire, and the scoring balloon catheter has high safety and reliability. Further, the scoring wire further includes a cutting part and a bottom with a concave arc shape, thereby having good combination stability with the balloon body, the scoring wire is not easy to be separated from the balloon body when the catheter is bent, the passing property and flexibility of the catheter are improved, and the incidence of scratching the normal blood vessel wall during the delivery process of the catheter can be reduced. BRIEF DESCRIPTION OF DRAWINGS

[0024] Other features, objects, and advantages of the present application will become more apparent from the following detailed description of non-limiting embodiments thereof as read with the accompanying drawings.

[0025] Figure 1 is a schematic view of a scoring balloon catheter according to an embodiment of the present application;

[0026] Figure 2 is a sectional view of a scoring wire according to an embodiment of the present application;

[0027] Figure 3 is a perspective view of a scoring wire according to an embodiment of the present application;

[0028] Figure 4 is a schematic view of a scoring assembly according to an embodiment of the present application;

[0029] Figure 5 is a perspective view of a connecting rod according to an embodiment of the present application;

[0030] Figure 6 is a sectional view of a balloon in a folded state according to an embodiment of the present application.

[0031] Reference numerals:

[0032] 1 catheter assembly 3 scoring assembly

[0033] 11 inner tube 31 scoring wire

[0034] 12 outer tube 311 cutting portion

[0035] 13 elastic tube 312 bottom portion

[0036] 2 balloon body 32 connecting rod

[0037] 21 leaflet 33 connecting bracket DETAILED DESCRIPTION

[0038] Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments, however, can be implemented in many different forms and should not be construed as limited to the implementations set forth herein; rather, these implementations are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art. Like reference numerals refer to like elements throughout the specification. "Or," "and," and "both" can be used interchangeably in the disclosure.

[0039] In the present application, the expression of the term "one embodiment", "some embodiments", "an example", "a specific example", or "some examples" and the like means that the specific features, structures, materials or characteristics represented in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. Moreover, the specific features, structures, materials or characteristics represented can be combined in any appropriate manner in any one or more embodiments or examples. In addition, different embodiments or examples represented in the present application and the features of different embodiments or examples can be combined and combined by those skilled in the art without contradiction.

[0040] It should be noted that the distal end in the utility model refers to the end away from the operator of the catheter, and the proximal end refers to the end close to the operator of the catheter.

[0041] To solve the problems in the prior art, the utility model provides a score wire and a score balloon catheter. In the field of medical devices, the score wire can also be called a wire knife, which generally refers to a physical structure having at least one sharp surface, thereby realizing surface cutting function.

[0042] Figure 1 For a specific embodiment of the score balloon catheter in the utility model, the score balloon catheter comprises a catheter assembly 1, a balloon body 2 and a score assembly 3. Understandably, in order to facilitate the display of each component of the score balloon catheter, Figure 1 The balloon and the catheter assembly are perspective (i.e. are made of transparent material), and part of the structure of the catheter assembly is drawn as a dashed line. The balloon body 2 is connected to the distal end of the catheter assembly 1; the score assembly 3 is sleeved on the outer wall of the balloon body 2. The catheter assembly 1 further comprises an inner tube 11 and an outer tube 12, and the outer tube 12 is sleeved on the outer side of part of the inner tube 11; the distal end of the inner tube 11 is arranged in the inner part of the balloon body 2 and is connected to the distal end of the balloon body 2; the proximal end of the balloon body 2 is connected to the distal end of the outer tube 12. The catheter assembly 1 further comprises an elastic tube 13, the proximal end of the elastic tube 13 is connected to the outer tube 12, the distal end of the elastic tube 13 is connected to the proximal end of the score assembly 3, and the proximal end of the score assembly 3 is arranged in the inner part of the elastic tube 13. The balloon body 2, the outer tube 12, the inner tube 11 and the elastic tube 13 can be made of polyamide elastomer or polyester high molecular material, and the utility model does not limit this.

[0043] The score assembly 3 comprises at least one score wire 31. Figure 2 And Figure 3The figures show a cross-sectional view and a partial perspective view of one embodiment of the scoring wire 31 in this invention. The scoring wire 31 has a pentagonal cross-section perpendicular to its axial direction, preferably a pentagonal cross-section with one concave side. Further, the scoring wire 31 includes a connected cutting portion 311 and a bottom portion 312, with the bottom portion 312 and the cutting portion 311 arranged radially opposite each other. The cutting portion 311 has a triangular cross-section perpendicular to its axial direction, and the bottom portion 312 has a concave arc cross-section perpendicular to its axial direction. Figure 2 The arc pointed to by the arrow at point 312 is the concave arc (concave means recessed relative to the scoring assembly), and the concave arc is opposite to the triangle. In this embodiment, the scoring wire 31 has a cross-section with rounded edges in the direction perpendicular to the axis of the scoring wire 31, which is a pentagonal shape. That is, the bottom 312 of the scoring wire 31 in contact with the balloon body 2 has a larger inner angle in the cross-section perpendicular to the axis of the scoring wire 31, to avoid the excessively sharp edge of the bottom of the scoring wire 31 from piercing or scratching the balloon body 2 and causing balloon failure. The cutting part 311 is located on the side of the bottom 312 away from the balloon body 2. The cross-section of the cutting part 311 perpendicular to the axis of the balloon body 2 is triangular, and the apex of the triangle is set towards the side of the scoring wire 31 away from the balloon body 2. The cutting part 311 with a triangular cross-section can cut the vascular plaque with less cutting force, improve the safety factor of the balloon body 2, and can quickly cut into the plaque to prevent the plaque from moving or sliding, ensuring accurate expansion position. Preferably, the aforementioned triangle can be an isosceles triangle or an equilateral triangle. The cross-sectional shape of the cut portion 311 is not limited to the triangle shown above.

[0044] In some embodiments, at least one scoring wire 31 in the scoring assembly 3 is spirally wound along the axial direction of the balloon body 2; and / or, at least one scoring wire 31 is arranged along an axial direction parallel to the balloon body 2. Further, the scoring assembly 3 forms a structure with a central axis, and at least a portion of the central axis of the scoring assembly 3 coincides with the central axis of the balloon body 2.

[0045] Figure 4 This is one embodiment of the scoring component 3 in this utility model. In this embodiment, the scoring component 3 has three scoring wires 31, each scoring wire 31 spirally wound along a central axis. Viewed from the direction of the three scoring wires 31 toward the central axis, the area enclosed by the three scoring wires 31 (or the scoring component 3) has a three-dimensional space; combined with... Figure 1 It can be understood that the space enclosed by the three scoring wires 31 (or scoring components 3) can accommodate the balloon body 2. (See reference) Figure 2 and Figure 3The embodiment of the shown score wire 31 structure, the score wire 31 includes a cutting part 311 and a bottom part 312 connected, the cutting part is located on the side of the score wire 31 away from the balloon body 2. The bottom part 312 of the score wire 31 has a concave circular arc shape in the cross section perpendicular to the axial direction of the score wire 31, and the circular arc shape of the score wire 31 matches the outer wall of the balloon body 2 when the balloon body 2 is inflated (also refer to Figure 1 ) The bottom part 312 of the score wire 31 is designed as a circular arc structure that matches the balloon body 2, so that the score wire 31 has good stability in combination with the balloon body 2, reduces the relative sliding of the score assembly 3 and the balloon body 2, and the score wire 31 is not easy to separate from the balloon body 2 when the score balloon catheter is bent, thereby improving the passability and flexibility of the catheter, and also reducing the incidence of normal blood vessel wall scratching during catheter delivery; and the balloon body 2 can also better transmit the expansion force to the score wire 31, so that the score assembly 3 expands smoothly and cuts the plaque smoothly.

[0046] Figure 4 The score assembly 3 also includes a connecting part, and the proximal end and the distal end of the score assembly 3 are also provided with a connecting rod 32 and a connecting bracket 33, and the connecting bracket 33 of the distal end and the proximal end is connected with the score wire 31 through the corresponding connecting rod 32; the connecting bracket 33 is used for fixing and limiting the two ends of the score wire 31. Preferably, the height of the connecting rod 32 and the connecting bracket 33 is less than the height of the score wire 31, so that the score balloon catheter product has a smaller outer diameter while ensuring the expansion depth of the score wire 31, thereby improving the passability and flexibility.

[0047] In some embodiments, the connecting rod 32 is parallel to the central axis of the score assembly 3. Further, as Figure 5 shown, the connecting rod 32 is a straight line type, and the connecting bracket 33 and / or the side of the connecting rod 32 close to the balloon body 2 is a concave circular arc structure, and the connecting rod 32 and the connecting bracket 33 are accommodated (also refer to Figure 1 ) on the side of the balloon body 2 close to the space surrounded by the score assembly in a circular arc shape to match the tube foot of the balloon body 2; the cross section of the connecting rod 32 and the connecting bracket 33 perpendicular to the score assembly 3 is a rectangular shape.

[0048] In some embodiments, a connecting rod 32 is provided between the connecting support 33 and the score wire 31. When the balloon body 2 is inflated, the score wire 31 expands radially as the balloon body 2 expands. The linear connecting rod 32 also bends as the score wire 31 expands radially, increasing the radial expansion diameter of the score assembly 3. The radial expansion of the score assembly 3 causes it to compress axially relative to the balloon body 2. The radial expansion of the score assembly 3 reduces the binding force on the balloon body 2, reducing the damage to the balloon body 2. In a preferred embodiment, when the score assembly 3 expands with the balloon body 2 and compresses axially, the score wire 31 on the score assembly 3 must be at least one circumferential turn around the balloon body 2 to ensure the cutting area per unit length and ensure that the cutting effect of the score assembly 3 meets the expected requirements.

[0049] In some embodiments, the number of score wires 31 forming the score assembly 3 is preferably 2-4. The score wire 31 can be made of, for example, nickel-titanium alloy or other materials with memory, so that it can return to its original state when the balloon body 2 is depressurized.

[0050] The space surrounded by the score wire 31 and / or the connecting rod 32 and the connecting support 33 of the score assembly 3 has a virtual outer surface, only part of the positions on the virtual outer surface are straight lines or curves of one or more score wires 31. In other words, the score assembly 3 has gaps formed therein. The score balloon catheter has a folded state, in which the distance between the score wire 31 of the score assembly 3 and the central axis of the score assembly 3 is reduced (see Figure 4 ). In the folded state, the shape of the balloon body 2 also changes. The balloon body 2 can be in a contracted state including a plurality of petals 21, and part of the petals 21 extend into the gap away from the central axis of the balloon body 2. The maximum distance between the outer surface of the petals 21 and the central axis of the balloon body 2 is greater than or equal to the maximum height of the score wire 31 from the central axis of the balloon body 2.

[0051] Figure 6This is an embodiment of a scored balloon catheter in its folded state. Specifically, in a cross-section perpendicular to the axial direction of the scored balloon catheter, for ease of illustration, only the scoring wire 31 and the final state of the balloon body 2 after folding and winding are shown (where 21 is the flap of the balloon body 2 in the folded state). As mentioned earlier, in the folded state, the folded flaps 21 of the balloon body 2 extend outwards along the gap away from the central axis of the balloon body 2, and the maximum distance from the outer surface of the flap 21 to the central axis of the balloon body 2 is greater than or equal to the maximum height of the scoring wire 31 from the central axis of the balloon body 2. Therefore, the scoring wire 31 is embedded between two adjacent flaps 21 extending outwards. When the folded balloon body 2 is delivered in a blood vessel, the flaps 21 extending outwards can prevent the scoring wire 31 from directly contacting the blood vessel wall, thereby avoiding the scoring wire 31 scratching the normal blood vessel wall during delivery and reducing the incidence of the scoring wire 31 scratching the blood vessel wall. Embedding the folded scoring wire 31 into the flap 21 can reduce the overall outer diameter of the distal end of the scoring balloon catheter, improving the product's passability and flexibility.

[0052] The specific operation method for dividing the lobes 21 of the scoring assembly 3 and the balloon body 2 can be as follows: First, the balloon body 2 is divided into lobes under vacuum conditions using a folding device, for example... Figure 6 The balloon body 2 is divided into three evenly spaced lobes 21. The three lobes 21 are then wound and pressed to form a cylindrical shape. Next, the processed scoring assembly 3 is fitted onto the outer surface of the balloon body 2. Then, a pressing device is used to press the balloon body 2 under a certain outer diameter constraint, and pressure is applied to the balloon body 2. The pressure forces the lobes 21 of the balloon body 2 into the gaps of the scoring assembly 3. Finally, the outer diameter of the constraint is further reduced, and the balloon lobes protruding from the scoring assembly 3 are flattened to cover the scoring wires 31 in the scoring assembly 3. This ensures that the maximum distance between the outer surface of the lobes 21 and the central axis of the balloon body 2, or the protrusion height of the lobes 21, is higher than or level with the maximum distance between the scoring wires 31 in the scoring assembly 3 and the central axis of the balloon body 2.

[0053] The notching component 3 can be obtained by processing the metal raw material tube according to the design drawing using methods such as laser cutting or machining. Then, the cut and processed notching component undergoes processes such as pickling, sandblasting, and polishing to finally form the required design dimensions. All structures on the notching component 3 can be integrally molded to simplify the manufacturing process of the notching component 3.

[0054] A contrast-enhancing ring is fixed at the distal end of the inner tube 6 for positioning during surgery. The contrast-enhancing ring can be made of materials such as platinum-iridium alloy, gold, or tungsten.

[0055] The catheter assembly 1 further comprises a hypotube and a connecting seat, the hypotube is connected with the balloon through the outer tube 12, the distal end of the hypotube is fixed to the proximal end of the outer tube 12 by laser welding or hot air welding, and the proximal end of the hypotube is fixed in the connecting seat by glue bonding. The hypotube can be made of metal materials such as stainless steel or nickel-titanium alloy, and the hypotube end seat is made of polyethylene material.

[0056] The connection between the distal end of the elastic tube 13 and the proximal end of the scoring assembly 3 can be achieved by embedding the proximal end connecting bracket 33 of the scoring assembly 3 into the elastic tube 13 through laser welding or hot air welding process, to form an integrated connection structure. The proximal end of the elastic tube 13 and the outer tube 12 are sealed and bonded together by means of point gluing. When the balloon body 2 and the scoring assembly 3 are expanded, the elastic function of the elastic tube 13 can help the scoring assembly 3 to expand radially, reduce the extrusion on the balloon body 2, and when the balloon body 2 is depressurized, the elastic tube 13 can help the scoring assembly 3 to shrink to the state before expansion, which is conducive to the smooth withdrawal of the catheter from the blood vessel.

[0057] The above is a further detailed description of the present application in combination with specific preferred embodiments and specific examples, and cannot be regarded as a limitation of the specific implementation of the present application. For ordinary skilled persons in the technical field to which the present application belongs, without departing from the concept of the present application, a number of simple deductions or substitutions can be made, which should be regarded as falling within the protection scope of the present application.

Claims

1. A scoring balloon catheter, characterized by, The application relates to a balloon catheter, which comprises: a catheter assembly; a balloon body connected to the distal end of the catheter assembly; a scoring assembly arranged on the outer wall of the balloon body; the scoring assembly comprises at least one scoring wire; the cross section of the scoring wire perpendicular to the axial direction of the scoring wire is pentagonal; the scoring wire comprises a cutting portion and a bottom portion connected to each other, and the bottom portion is arranged opposite to the cutting portion in the radial direction of the scoring wire; the cross section of the cutting portion perpendicular to the axial direction of the scoring wire is triangular, the cross section of the bottom portion perpendicular to the axial direction of the scoring wire comprises a concave circular arc, and the concave circular arc is opposite to the triangle; the triangle is an equilateral triangle; the cutting portion is located on the side of the scoring wire away from the balloon body; the cross section of the bottom portion of the scoring wire perpendicular to the axial direction of the scoring wire has a concave circular arc shape, and the circular arc shape is matched with the outer wall of the balloon body when the balloon body is inflated; the scoring assembly further comprises a connecting support and a connecting rod arranged at the distal end and a connecting support and a connecting rod arranged at the proximal end, and the connecting supports at the distal end and the proximal end are connected to the scoring wire through the corresponding connecting rods; the height of the connecting rod and the height of the connecting support are both smaller than the height of the scoring wire.

2. The scoring balloon catheter of claim 1, wherein, at least one of the scoring wires is arranged in a spiral along the axial direction of the balloon body; and / or at least one of the scoring wires is arranged in parallel to the axial direction of the balloon body.

3. The scoring balloon catheter of claim 1, wherein, The scoring assembly forms a structure with a central axis, and the central axis of the scoring assembly coincides with at least a part of the central axis of the balloon body.

4. The scored balloon catheter of any of claims 1-3, wherein, The scoring assembly forms a gap, and the scoring balloon catheter has a folded state, in which the balloon body comprises a plurality of petals, and part of the petals extend out of the gap in the direction away from the central axis of the balloon body, and the maximum distance between the outer surface of the petals and the central axis of the balloon body is greater than or equal to the maximum height of the scoring wire from the central axis of the balloon body.

5. The scored balloon catheter of any of claims 1-3, wherein, The catheter assembly comprises an inner tube and an outer tube, and the outer tube is arranged outside part of the inner tube; the distal end of the inner tube is arranged inside the balloon body and connected to the distal end of the balloon body; and the proximal end of the balloon body is connected to the distal end of the outer tube.

6. The scoring balloon catheter of claim 1, wherein, The side of the connecting support and / or the connecting rod close to the balloon body is a concave circular arc structure.

7. The scoring balloon catheter of claim 1, wherein, The connecting rod is parallel to the axial direction of the balloon body, and the side of the connecting rod close to the balloon body is matched with the outer wall of the balloon body.

8. The scoring balloon catheter of claim 1, wherein, The catheter assembly comprises an outer tube and an elastic tube, the proximal end of the balloon body is connected to the distal end of the outer tube, the proximal end of the elastic tube is connected to the outer tube, the distal end of the elastic tube is connected to the proximal end of the connecting support, and the elastic tube is arranged outside the outer tube, the connecting support at the proximal end and the connecting rod at the proximal end.

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