Scoring balloon catheter

Abstract

The scoring balloon catheter of the present invention includes a catheter holder, an inner tube, an outer tube, a balloon body, a scoring element, and a torsion guidewire. The outer tube is fitted over the inner tube, and the proximal end of the outer tube is connected to the catheter holder and the distal end is connected to the balloon body. The scoring element is axially attached to the outer wall of the balloon body, and both ends of the torsion guidewire are connected to the balloon body and the catheter holder, respectively. The torsion guidewire is located on the inner tube, between the inner and outer tubes, or on the outer tube, and the scoring element and the torsion guidewire are located on the same radial cross section. In the present invention, the torsion guidewire is located on the inner or outer tube, or between the inner and outer tubes, so that the torque of the catheter holder can be transmitted to the balloon body. Furthermore, the torsion guidewire is located on the same radial cross section as the scoring element, which effectively achieves accurate alignment of the scoring element with the lesion location, allowing the scoring element to cut the lesion in a directional manner, significantly improving the effect of vasoconstriction and dilation during angioplasty. Furthermore, the scoring member has excellent flexibility due to the various structural designs that can be implemented.

Description

【Technical Field】 , 【0001】 [Cross - reference to Related Applications] This application claims the priority of a Chinese patent application with an application number of 202410519258.6 and an invention title of "Scoring Balloon Catheter", which was filed with the China National Intellectual Property Administration on April 28, 2024, and the entire content of which is incorporated herein by reference. 【0002】 [Technical Field] This application belongs to the technical field of medical devices, and particularly relates to a scoring balloon catheter. 【Background Art】 【0003】 For many years, arterial occlusion in the human body has been a major medical problem. This is because arterial occlusion reduces blood flow through the artery and further causes various serious complications. Arterial stenosis is mainly due to the deposition of cholesterol, calcium, and fibrotic tissue, and angioplasty is probably the most commonly used treatment method. The process of angioplasty involves expanding the occluded artery with an inflatable balloon, but this treatment method has the problem of a high restenosis rate. 【0004】 To solve the above problems, scoring balloons have emerged. The scoring member of the balloon can enhance the stenosis expansion effect by cutting the stenosis during angioplasty. <00​​​​​​​​​ [Problems that the invention aims to solve] 【0007】 The present invention aims to provide a scoring balloon catheter that can effectively achieve accurate alignment between the scoring member and the lesion location, thereby improving the stenosis dilation effect. [Means for solving the problem] 【0008】 To solve the above technical problems, this application includes a catheter holder, an inner tube, an outer tube, and a balloon body, wherein the outer tube is fitted to the outside of the inner tube, the proximal end of the outer tube is connected to the catheter holder, and the distal end is connected to the balloon body. The present invention provides a scoring balloon catheter further comprising a scoring member and a torsion guide wire, wherein the scoring member is provided on the outer wall of the balloon body and is arranged in a direction parallel to the axial direction of the balloon body, the torsion guide wire is located in the intermediate intervening layer, outer wall or inner wall of the inner tube, or the torsion guide wire is located between the inner tube and the outer tube, or the torsion guide wire is located in the intermediate intervening layer, outer wall or inner wall of the outer tube, and the scoring member is located on the same radial cross-section as the torsion guide wire. 【0009】 In the above scoring balloon catheter, the scoring members are multiple, The torsion guide wires are either multiple wires that correspond one-to-one with the scoring members, or the number of torsion guide wires is one or more, and the torsion guide wires correspond one-to-one with some of the scoring members. 【0010】 In the scoring balloon catheter described above, at least one developing ring is provided at the distal end of the torsion guidewire, and / or, the scoring member is provided with at least one developing ring, And / or, the inner tube corresponding to the scoring member is provided with at least one developing ring. 【0011】 In the scoring balloon catheter described above, the torsion guidewire is a variable-diameter guidewire, and the diameter of the variable-diameter guidewire gradually decreases from the proximal end to the distal end. 【0012】 In the scoring balloon catheter described above, the scoring member has a rack structure on the surface opposite to the balloon body, which is serrated. 【0013】 In the scoring balloon catheter described above, the cross-section of the scoring member is L-shaped, and / or, a plurality of engagement grooves are provided at intervals on the surface of the scoring member facing the balloon body, and these engagement grooves are used to adhere to the balloon body with an adhesive. 【0014】 In the scoring balloon catheter described above, the scoring member is provided with folds in the longitudinal direction, and the thickness of the scoring member at the folds is smaller than the thickness of the portion without folds. 【0015】 In the above-mentioned scoring balloon catheter, the scoring member is a coil spring structure, which is optional. 【0016】 In the scoring balloon catheter described above, if the torsion guidewire is located in the intermediate layer, outer wall, or inner wall of the inner tube, the torsion guidewire is integrally molded with the inner tube or bonded to it. When the torsion guide wire is located in the intermediate layer, outer wall, or inner wall of the outer tube, the torsion guide wire is integrally molded with the outer tube or bonded to it. When the torsion guidewire is located between the inner tube and the outer tube, both ends of the torsion guidewire are connected to the balloon body and the catheter holder, respectively, and part or all of the torsion guidewire is connected to the outer wall of the inner tube. 【0017】 In the above scoring balloon catheter, the balloon body has a cylindrical structure in the middle and conical structures at both ends, with the middle cylindrical structure being the working segment and the conical structures at both ends being the non-working segments. The scoring member is provided in the intermediate cylindrical structure of the balloon body. If there are multiple scoring members, the multiple scoring members are provided evenly on the outer surface of the balloon body in the circumferential direction. 【0018】 This invention provides a scoring balloon catheter, the beneficial effects of which are as follows: 【0019】 By providing a torsion guidewire in the inner or outer tube, or between the inner and outer tubes, the torque of the catheter holder can be transmitted to the balloon body. Furthermore, since the torsion guidewire is located on the same radial cross-section as the scoring member, accurate alignment between the scoring member and the lesion can be effectively achieved. The scoring member then precisely cuts the lesion, significantly improving the effect of vascular stenosis dilation during angioplasty. In addition, the scoring member can be made to have excellent flexibility through various structural designs. 【0020】 To more clearly illustrate the embodiments of the present application or the prior art, the drawings that may be used to describe the embodiments or the prior art are briefly described below. It is clear that the drawings described below are merely embodiments of the present application, and a person skilled in the art could obtain other drawings based on these without any creative effort. [Brief explanation of the drawing] 【0021】 [Figure 1]It is a structural schematic diagram of a scoring balloon catheter according to an embodiment of the present application. [Figure 2] It is a partial enlarged view of part A in FIG. 1. [Figure 3] It is a partial cross-sectional view of FIG. 2. [Figure 4] It is a partial enlarged view of part B in FIG. 3. [Figure 5] It is a cross-sectional view of the C-C part in FIG. 3. [Figure 6] It is a structural schematic diagram of a variable-diameter guide wire according to an embodiment of the present application. [Figure 7] It is a structural schematic diagram before bending of the bottom of the first scoring member according to an embodiment of the present application. [Figure 8] It is a partial enlarged view of part D in FIG. 7. [Figure 9] It is a partial structural schematic diagram after bending of the bottom of the first scoring member according to an embodiment of the present application. [Figure 10] It is a cross-sectional view of the first scoring member according to an embodiment of the present application. [Figure 11] It is a structural schematic diagram of the second scoring member according to an embodiment of the present application. [Figure 12] It is a partial enlarged view of part E in FIG. 11. [Figure 13] It is a structural schematic diagram of the fourth scoring member according to an embodiment of the present application. [Figure 14] It is a partial enlarged view of part F in FIG. 13. 【Mode for Carrying Out the Invention】 【0022】 Hereinafter, embodiments of the present application will be described in detail. The embodiments are illustrated in the drawings, and throughout the entire specification, the same or similar reference numerals indicate the same or similar elements, or elements having the same or similar functions. It should be understood that the embodiments described below with reference to the drawings are exemplary and are only used for interpreting the present application and do not limit the present application. 【0023】 It should be understood that, in the description of this application, the terms "proximal end" and "distal end" as used throughout the specification refer to the proximal and distal ends relative to the operator. When using this application, the end closer to the physician or operator is the "proximal end," i.e., the end where the operator is located, and the end further away from the physician or operator is the "distal end," i.e., the end where the balloon is located. The above-mentioned explanation of orientations is for the convenience and simplification of the description of this application and does not indicate or imply that such devices or elements necessarily have a specific orientation or are configured and operated in a specific orientation, and therefore does not limit this application. 【0024】 The core of this invention is to provide a scoring balloon catheter that can effectively achieve accurate alignment between the scoring member and the lesion location, thereby improving the stenosis dilation effect. 【0025】 To enable those skilled in the art to better understand the technical proposal relating to this application, the present application will be described in more detail below with reference to the drawings and specific embodiments. 【0026】 Specifically, as shown in Figures 1 to 14, the embodiment of the present application discloses a scoring balloon catheter, in which the scoring balloon catheter includes a catheter holder 5, an inner tube 3, an outer tube 4, a balloon body 1, a scoring member 2, and a torsion guidewire 6. Typically, a terminal tube may be further provided at the distal end of the balloon body 1 as needed. 【0027】 Here, the catheter holder 5 has a hollow structure, and the catheter holder 5 is provided with a balloon pressurization / depressurization port 502 and a guide wire guide port 501. 【0028】 An outer tube 4 is fitted to the outside of the inner tube 3. Specifically, the terminal tube, balloon body 1, and outer tube 4 are fitted sequentially to the inner tube 3 from distal to proximal. The cavity of the inner tube 3 is a guidewire cavity a, which communicates with a guidewire guide port 501. During use, the guidewire is guided from the terminal tube into the guidewire cavity a of the scoring balloon catheter and then pulled out of the body through the guidewire guide port 501. Guiding the guidewire can assist in the delivery of intervention devices based on the scoring balloon catheter. 【0029】 The proximal end of the outer tube 4 is connected to the catheter holder 5, and the balloon body 1 is provided at the distal end of the outer tube 4. A balloon filling cavity b is formed between the inner wall of the outer tube 4 and the outer wall of the inner tube 3. The balloon pressurization / depressurization port 502 communicates with the cavity of the balloon body 1 via the balloon filling cavity b and is used to inflate or depressurize the balloon body 1. 【0030】 The scoring member 2 is a member that cuts the lesion location, and specifically, it is provided on the outer wall of the balloon body 1 and is positioned along the axial direction of the balloon body 1. In order to address the problem that conventional scoring balloons cannot effectively and accurately align the scoring member 2 with the lesion location, a torsion guide wire 6 is provided in addition. 【0031】 Specifically, the torsion guide wire 6 may be provided in the intermediate intervening layer, outer wall, or inner wall of the inner tube 3, and if necessary, the torsion guide wire 6 may be provided between the inner tube 3 and the outer tube 4, and furthermore, the torsion guide wire 6 may be provided in the intermediate intervening layer, outer wall, or inner wall of the outer tube 4. A person skilled in the art can select the installation position of the torsion guide wire 6 according to actual needs, and in this embodiment, the specific installation position of the torsion guide wire 6 is not limited. 【0032】 The scoring member 2 should be positioned on the same radial cross-section as the torsion guidewire 6. This allows the position of the scoring member 2 to be determined by observing the position of the torsion guidewire 6. Furthermore, the torsion guidewire 6 can improve the torsional strength of the scoring balloon catheter. By twisting the catheter holder 5, torque can be transmitted from the torsion guidewire 6 to the balloon body 1, thereby directionally twisting the scoring member 2 and accurately aligning it with the lesion to be cut. 【0033】 Furthermore, when the torsion guidewire 6 is provided between the inner wall of the outer tube 4 and the outer wall of the inner tube 3, the torsion guidewire 6 can transmit 100% of the torque at its proximal end to the balloon body 1. The torsion guidewire 6 extends within the space between the outer tube 4 and the inner tube 3, with one end located on the side where the catheter holder 5 is positioned and the other end extending to the proximal end of the balloon body 1. As a result, by twisting the catheter holder 5, the balloon body 1 can be rotated in accordance with the torque transmitted by the torsion guidewire 6. Both ends of the torsion guidewire 6 must be fixed to the inner tube 3 and the outer tube 4, respectively, and part or all of the torsion guidewire 6 must be connected to the outer wall of the inner tube 3 (i.e., the middle part of the torsion guidewire 6 also needs to be fixed; for example, the entire torsion guidewire 6 is fixed to the outer wall of the inner tube, or part or several spaced portions of the torsion guidewire 6 are fixed to the outer wall of the inner tube). 【0034】 When the torsion guide wire 6 is provided in the inner tube 3, specifically, it may be connected to the inner wall or outer wall of the inner tube 3 (the two may be integrally molded structures or connected by adhesive, etc.), or the torsion guide wire 6 may be provided in the intermediate layer of the inner tube 3 (that is, the torsion guide wire 6 is provided between the outer wall and the inner wall of the inner tube 3, thereby providing a torque transmission effect to the inner tube 3). 【0035】 When the torsion guide wire 6 is provided on the outer tube 4, specifically, it may be connected to the inner wall or outer wall of the outer tube 4 (the two may be integrally molded structures or connected by adhesive, etc.), or it may be located in the intermediate layer of the outer tube 4 (that is, the torsion guide wire 6 is provided between the outer wall and the inner wall of the outer tube 4, thereby providing a torque transmission effect to the outer tube 4). 【0036】 As described above, the scoring balloon catheter according to the present invention has a torsion guide wire 6 provided in the inner tube 3 or outer tube 4, or between the inner tube 3 and the outer tube 4, which allows the torque of the catheter holder 5 to be transmitted to the balloon body 1. Furthermore, since the torsion guide wire 6 is located on the same radial cross-section as the scoring member 2, the position of the torsion guide wire 6 can be observed at the proximal end to determine the position of the scoring member 2, effectively achieving accurate alignment between the scoring member 2 and the lesion location. The scoring member 2 then precisely cuts the lesion, significantly improving the effect of vascular stenosis dilation during angioplasty. 【0037】 If there is one scoring member 2, then there is also one torsion guide wire 6. If there are multiple scoring members 2, the multiple scoring members 2 are distributed in the circumferential direction of the balloon body 1. In one embodiment, there are multiple torsion guide wires 6 that correspond one-to-one with the scoring members 2, that is, the number of torsion guide wires 6 and scoring members 2 are equal, and their positions correspond. In another embodiment, there are multiple torsion guide wires 6, and the torsion guide wires 6 correspond one-to-one with some of the scoring members 2. That is, the number of torsion guide wires 6 is smaller than the number of scoring members 2, and in this case, the torsion guide wires 6 can achieve a positional correspondence with some of the scoring members 2 according to predetermined conditions, and these predetermined conditions may be positional relationships or methods to facilitate operation. For example, if there are four scoring members 2, one scoring member 2 is arranged at 90° intervals around the circumferential direction of the balloon body 1. In this embodiment, only two torsion guide wires 6 may be arranged, and these two torsion guide wires 6 correspond to two of the scoring members 2, respectively. For example, one torsion guide wire 6 may correspond to one scoring member 2, and after a 180° interval, the other torsion guide wire 6 may correspond to the other scoring member 2. The operator can uniquely predict that there is still a corresponding scoring member 2 at the midpoint between the two torsion guide wires 6, that is, even if there are no torsion guide wires 6, the position of the scoring member 2 can be determined by reasonable prediction. 【0038】 The torsion guide wire 6 and the scoring member 2 of the balloon body 1 are located in a straight line, and there is a one-to-one correspondence between them. The torsion guide wire 6 may be one or more, depending on the number of scoring members 2. 【0039】 In specific embodiments, the torsion guide wire 6 can be made of a metal material with excellent torque transmission characteristics, and the outer tube 4 can be made of a transparent material. Because the outer tube 4 is transparent, if the torsion guide wire 6 is installed in the outer tube 4 or between the inner tube 3 and the outer tube 4, the operator can visually see the torsion guide wire 6 at its proximal end. If the torsion guide wire 6 is installed on the inner wall of the inner tube 3 or in an intermediate interlayer, observation of the torsion guide wire 6 can also be achieved by designing the inner tube 3 as a transparent material. Of course, observation of the torsion guide wire 6 can also be achieved in the same way without designing the outer tube 4 as a transparent material by marking the position of the torsion guide wire 6 at the proximal end of the outer tube 4. 【0040】 Furthermore, to more intuitively identify the position of the scoring member 2, at least one developing ring 7 is provided at the distal end of the torsion guide wire 6. The developing ring 7 is used to indicate the position of the torsion guide wire 6 within the patient's body. Since the torsion guide wire 6 and the scoring member 2 are located on the same straight line, the operator can further identify the position of the scoring member 2 by observing the position of the torsion guide wire 6. At least one developing ring 7 is provided on the scoring member 2, and / or at least one developing ring 7 is provided on the inner tube 3 corresponding to the scoring member 2. That is, developing rings 7 may be provided at all three positions: the torsion guide wire 6, the scoring member 2, and the inner tube 3 corresponding to the scoring member 2. Alternatively, developing rings 7 may be provided at only some of these positions. In this embodiment, the specific position of the developing rings 7 is not limited; it is sufficient that the position of the scoring member 2 can be indicated. 【0041】 When using the scoring balloon catheter disclosed in the embodiments of this application, first, the deflated balloon body 1 is sent to the lesion in the blood vessel. If it is necessary to adjust the position of the scoring member 2, the catheter holder 5 is rotated to rotate the outer tube 4 and inner tube 3 in conjunction, and then the balloon body 1 and scoring member 2 are rotated in conjunction to observe the position of the torsion guide wire 6. The torsion guide wire 6 is rotated until it is positioned in the same radial cross-section as the lesion. Since the torsion guide wire 6 is positioned in the same radial cross-section as the scoring member 2, the scoring member 2 is aligned with the lesion. Subsequently, the balloon body 1 is inflated through the balloon filling cavity b via the balloon pressurization / depressurization port 502, and the scoring member 2 contacts the lesion and cuts it in a directional manner. 【0042】 Based on the specific implementation described above, the torsion guidewire 6 may be a variable-diameter guidewire, and the diameter of the variable-diameter guidewire gradually decreases from the proximal end (located on the catheter holder 5 side) to the distal end (located on the balloon body 1 side). The advantages of providing the torsion guidewire 6 as a torsion member in a variable-diameter form are that, because the diameter of the proximal end is large, the torsion guidewire 6 can satisfy the torque transmission function, and because the diameter of the distal end is small, the distal end has excellent flexibility, making it easier for the distal end to pass through tortuous blood vessels. Furthermore, the thickness of the variable-diameter guidewire can be adjusted according to the actual load conditions, further improving load-bearing capacity, reducing material consumption, lowering manufacturing costs, and improving the performance and economics of the mechanical design. 【0043】 Specifically, the balloon body 1 has a cylindrical structure in the middle and conical structures at both ends. The cylindrical middle section is the working segment, i.e., the part that can exert a vasodilatory effect, while the conical ends are non-working segments. A developing ring 7 is provided on the outer surface of the inner tube 3 corresponding to the balloon body 1, and the developing ring 7 allows the balloon body 1 to be positioned at the lesion site. 【0044】 The diameter of the balloon body 1 is 1.0 mm to 40.0 mm, and its length is 10 mm to 300 mm. The specific dimensions of the balloon body 1 can be selected according to the actual application scenario, and in this embodiment, the diameter and length of the balloon body 1 are not limited. 【0045】 The material of the balloon body 1 includes one or more of the following: polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or a polymer material with excellent biocompatibility. The material of the balloon body 1 may be the same as the material commonly used in the prior art, and this is not the focus of this embodiment; those skilled in the art can select a material that meets the requirements as needed. 【0046】 The scoring members 2 may be fixed to the surface of the intermediate cylindrical structure of the balloon body 1, and the scoring members 2 may be arranged along a direction parallel to the axial direction of the balloon body 1 and may usually be fixed by bonding with an adhesive. The number of scoring members 2 is n, where n is an integer of 1 or more, and if there are multiple scoring members 2, they may be evenly distributed circumferentially on the outer surface of the balloon body 1, and the circumferential spacing angle between any two adjacent scoring members 2 is 360° / n, and optionally, the number of scoring members 2 may be three, and the circumferential spacing angle between any two corresponding adjacent scoring members 2 is 120°. 【0047】 The scoring member 2 can be adaptively modified to allow for various design configurations to be adopted as needed. 【0048】 In the first embodiment, the scoring member 2 has a rack structure on the surface opposite to the balloon body 1, which is serrated. As shown in Figures 7 and 8, the surface of the scoring member 2 opposite to the balloon body 1 is serrated, and the serrated structure consists of multiple teeth provided at intervals. By adopting this structure, the flexibility of the scoring member 2 can be improved, making it easier to pass through meandering blood vessels. Here, grooves are formed between adjacent teeth, and the width of the grooves may be 0.05 mm to 0.2 mm, the depth of the grooves may be 0.05 mm to 0.4 mm, and the spacing between the grooves may be 0.1 mm to 2 mm. As those skilled in the art will understand, the provision of grooves increases the flexibility of the scoring member 2, and when the scoring member 2 deforms, the grooves provide space for the displacement of the teeth. Also, because the grooves have a certain depth, the thickness corresponding to the grooved portion is thin, making it easier to deform, and making it easier for the scoring member 2 to pass through meandering blood vessels. The width and depth dimensions of the grooves can be set as needed. 【0049】 The scoring member 2 has an L-shaped cross-section, that is, as shown in Figures 7 and 8, it is bent at a position of about 0.1 mm to 0.2 mm from the bottom edge of the scoring member 2, forming the "L" shaped bent structure shown in Figures 9 and 10. As a result, the side of the scoring member 2 facing the balloon body 1 has a larger surface area, which increases the contact area between the scoring member 2 and the surface of the balloon body 1, allowing the scoring member 2 to be more firmly adhered to the surface of the balloon body 1. 【0050】 In the second embodiment, the surface of the scoring member 2 opposite to the balloon body 1 is serrated, and the serrated structure consists of multiple teeth provided at intervals. By adopting such a structure, the flexibility of the scoring member 2 is improved, making it easier to pass through meandering blood vessels. A groove is formed between adjacent teeth, and the depth of the groove may be 0.2 mm to 0.5 mm, the width of the groove may be 0.05 mm to 0.2 mm, the depth of the groove may be 0.05 mm to 0.3 mm, and the spacing between the grooves may be 0.1 mm to 2 mm. 【0051】 Multiple engagement grooves are provided at intervals on the surface of the scoring member 2 facing the balloon body 1, and these engagement grooves are used to bond the scoring member 2 to the balloon body 1 with adhesive. As shown in Figures 11 and 12, the engagement grooves may also be T-shaped holes, and multiple T-shaped holes are provided at intervals on the bottom of the scoring member 2, with the T-shaped holes positioned to correspond to the teeth between the grooves. That is, in the height direction, the T-shaped holes should avoid the positions of the grooves, preventing the bottom thickness of the grooves from being too thin and compromising the strength of the scoring member 2. Since the T-shaped holes are provided on the side facing the balloon body 1, when bonding with adhesive, the adhesive can enter the T-shaped holes, and after the adhesive hardens, the hardened adhesive and the scoring member 2 form a physical engagement structure, which is stronger than bonding with adhesive alone in the first embodiment. 【0052】 Based on the first embodiment, a third embodiment (not shown) can be designed to further enhance the flexibility of the scoring member 2. The scoring member 2 is a bar structure in which the surface opposite to the balloon body 1 is serrated, and it is bent at the bottom edge to form an "L" shaped bent structure. In addition, the scoring member 2 has fold points in the longitudinal direction, and the thickness of the scoring member 2 at the fold points is smaller than the thickness at the parts where there are no fold points. 【0053】 Similarly, a fourth form can be designed based on the second form, in which the scoring member 2 is a bar structure with a sawtoothed surface on the side opposite to the balloon body 1, and multiple engagement grooves are provided at intervals on the surface of the scoring member 2 facing the balloon body 1, and these engagement grooves are used to bond it to the balloon body 1 with adhesive. In addition, the scoring member 2 is provided with fold points in the longitudinal direction, and the thickness of the scoring member 2 at the fold points is smaller than the thickness at the parts where there are no fold points. 【0054】 As shown in Figures 13 and 14, several folds are added to the middle part of the scoring member 2. The thickness at the folds may be 1 / 4 to 3 / 4 of the thickness at other parts of the scoring member 2. Multiple folds may be provided along the length of the scoring member 2. The spacing between two adjacent folds may be designed to be 1 mm to 10 mm. The specific spacing dimension can be selected according to the total length of the scoring member 2. In this embodiment, the design of the folds can increase the flexibility of the scoring member 2. The folds and sawtooth structure can increase the curvature of the scoring member 2 in different directions, improving its passage through meandering blood vessels. 【0055】 Based on the first, second, third, and fourth embodiments described above, the ends of the scoring member 2 can also be designed in an arc shape to prevent scratching of blood vessels. The scoring member 2 is made of a metal plate material such as stainless steel, and both the groove and the engagement groove can be formed by laser cutting. 【0056】 In the fifth embodiment, the scoring member 2 has a coil spring structure. The scoring member 2 employs a coil spring structure wound with flat wire, and after winding, the cross-section of the scoring member 2 becomes an isosceles triangle (the vertex angle is less than 60 degrees) (the cross-section may be other polygonal structures). When the scoring member 2 is wound with nickel-titanium flat wire, although not shown in the figures, the spacing may be 0 to 0.076 mm, and this structure can also increase the flexibility of the scoring member 2, and the material of the scoring member 2 is a nickel-titanium alloy, which has good shape memory properties. 【0057】 As described above, the scoring balloon catheter disclosed in the embodiments of this application has the following beneficial effects. 【0058】 1) By providing a variable-diameter guide wire between the inner tube 3 and the outer tube 4 to transmit torque, the position of the scoring member 2 can be adjusted by rotating the catheter holder 5. 【0059】 2) By positioning the variable-diameter guide wire on the same radial cross-section as the scoring member 2, the position of the scoring member 2 can be obtained by observing the position of the variable-diameter guide wire, thereby achieving the objective of directional cutting. 【0060】 3) The scoring member 2 has excellent flexibility to adapt to tortuous blood vessels through various structural designs. 【0061】 As shown in the present application and claims, unless the context explicitly indicates an exception, words such as “one,” “one,” “one kind,” and / or “the” do not refer to the singular form but may also include the plural form. Generally, the terms “includes” and “inclusion” indicate only the inclusion of explicitly stated steps and elements, and these steps and elements do not constitute a single exclusive list; a method or apparatus may also include other steps or elements. An element limited by the phrase “includes one…” does not preclude other identical elements from being included in a process, method, product or apparatus that contains the element. 【0062】 Herein, in the description of the embodiments of this application, unless otherwise specified, " / " means "or," for example, A / B can mean A or B, and "and / or" in this specification merely describes the relationship between related objects, indicating that there are three types of relationships, for example, A and / or B can indicate the existence of A only, the existence of both A and B, and the existence of B only. Also, in the description of the embodiments of this application, "plural" means two or more. 【0063】 In the description of this application, unless otherwise explicitly stated, words such as "install," "attach," and "connect" should be understood in a broad sense, and a person skilled in the art can appropriately determine the specific meaning of these words in this application by referring to the specific content of the technical proposal. 【0064】 Each example in this specification is described progressively, with emphasis on the differences between each example and the others. Parts of each example that are the same or similar should be referenced to one another. 【0065】 This specification has described the principles and embodiments of the present application using specific examples, but the above description of examples is used solely to help understand the method and central idea of ​​the present application. Those skilled in the art can make various improvements and modifications to the present application without departing from the principles, and these improvements and modifications also fall within the scope of protection of the claims of the present application. [Explanation of symbols] 【0066】 1-Balloon body; 2-Scoring component; 3-Inner tube; 4-Outer tube; 5-Catheter holder; 501-Guide wire guide port; 502-Balloon pressurization / depressurization port; 6-Twisted guide wire; 7-Developing ring; a- Guidewire cavity; b- Balloon filling cavity

Claims

[Claim 1] A scoring balloon catheter comprising a catheter holder (5), an inner tube (3), an outer tube (4), and a balloon body (1), wherein the outer tube (4) is fitted to the outside of the inner tube (3), the proximal end of the outer tube (4) is connected to the catheter holder (5), and the distal end is connected to the balloon body (1). The balloon further includes a scoring member (2) and a torsion guide wire (6), wherein the scoring member (2) is provided on the outer wall of the balloon body (1) and is arranged in a direction parallel to the axial direction of the balloon body (1), the torsion guide wire (6) is located in the intermediate intervening layer, outer wall or inner wall of the inner tube (3), or the torsion guide wire (6) is located between the inner tube (3) and the outer tube (4), or the torsion guide wire (6) is located in the intermediate intervening layer, outer wall or inner wall of the outer tube (4), and the scoring member (2) is located on the same radial cross-section as the torsion guide wire (6). The torsion guide wire (6) transmits torque from the catheter holder (5) to the balloon body (1), thereby being used to directionally twist the scoring member (2). The scoring member (2) has a rack structure on the surface opposite to the balloon body (1) that is serrated, and the scoring member (2) has fold points in the longitudinal direction, and the thickness of the scoring member (2) at the fold points is smaller than the thickness of the parts where there are no fold points. The torsion guide wire (6) is a plurality of wires that correspond one-to-one with the scoring member (2), or the number of torsion guide wires (6) is one or more, and the torsion guide wire (6) corresponds one-to-one with some of the scoring members (2), The scoring balloon catheter is characterized in that the torsion guidewire (6) is a variable-diameter guidewire, and the diameter of the variable-diameter guidewire gradually decreases from the proximal end to the distal end. [Claim 2] The scoring balloon catheter according to claim 1, characterized in that at least one developing ring (7) is provided at the distal end of the torsion guide wire (6). [Claim 3] The scoring balloon catheter according to claim 1, characterized in that at least one developing ring (7) is provided on the scoring member (2). [Claim 4] The scoring balloon catheter according to claim 1, characterized in that at least one developing ring (7) is provided in the inner tube (3) corresponding to the scoring member (2). [Claim 5] The scoring balloon catheter according to any one of claims 1 to 3, characterized in that the cross-section of the scoring member (2) is L-shaped. [Claim 6] The scoring balloon catheter according to any one of claims 1 to 3, characterized in that a plurality of engagement grooves are provided at intervals on the surface of the scoring member (2) facing the balloon body (1), and the engagement grooves are used to adhere to the balloon body (1) with an adhesive. [Claim 7] When the torsion guide wire (6) is located in the intermediate intervening layer, outer wall, or inner wall of the inner tube (3), the torsion guide wire (6) is integrally molded with the inner tube (3) or bonded to it. When the torsion guide wire (6) is located in the intermediate intervening layer, outer wall, or inner wall of the outer tube (4), the torsion guide wire (6) is integrally molded with the outer tube (4) or bonded to it. The scoring balloon catheter according to claim 1, characterized in that when the torsion guide wire (6) is located between the inner tube (3) and the outer tube (4), both ends of the torsion guide wire (6) are connected to the balloon body (1) and the catheter holder (5), respectively, and a part or all of the torsion guide wire (6) is connected to the outer wall of the inner tube (3). [Claim 8] The balloon body (1) has a cylindrical structure in the middle and conical structures at both ends, with the middle cylindrical structure being the operating segment and the conical structures at both ends being the non-operating segments. The scoring member (2) is provided in the intermediate cylindrical structure of the balloon body (1). The scoring balloon catheter according to claim 1, characterized in that, if there are multiple scoring members (2), the multiple scoring members (2) are evenly provided on the outer surface of the balloon body (1) in the circumferential direction.

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