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 priority to a Chinese patent application bearing application number 202410519258.6 and entitled "Scoring Balloon Catheter" filed with the China Patent Office on April 28, 2024, the entire contents of which are incorporated herein by reference.

[0002] [Technical field] This application relates to the technical field of medical devices, and more particularly to scoring balloon catheters. [Background technology]

[0003] For many years, arterial blockage in the human body has been a major medical problem. This is because arterial blockage reduces blood flow through the arteries and leads to various serious complications. Arterial stenosis is mainly caused by the deposition of cholesterol, calcium, and fibrotic tissue, and angioplasty is perhaps the most commonly used treatment method. The angioplasty process involves dilating the blocked artery with an inflatable balloon, but this treatment has the problem of a high rate of restenosis.

[0004] To solve the above problems, scoring balloons have been developed, and the scoring element of the balloon can cut the stenotic part during angioplasty, thereby enhancing the effect of dilating the stenosis.

[0005] However, because most arterial stenoses form as eccentric lesions, i.e., the lesions do not extend completely around the circumference of the affected body vessel, conventional scoring balloons are unable to effectively align the scoring element accurately to the lesion location, resulting in poor stenotic dilation effects for eccentric lesions.

[0006] Therefore, how to achieve accurate alignment between the scoring member and the lesion position to improve the stenosis dilation effect has become a pressing issue for those skilled in the art. Summary of the Invention [Problem to be solved by the invention]

[0007] The present application 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] In order to solve the above technical problems, the present application provides a catheter holder, an inner tube, an outer tube, and a balloon body, the outer tube being fitted onto the outside of the inner tube, the outer tube having a proximal end connected to the catheter holder and a distal end connected to the balloon body, The scoring balloon catheter further includes a scoring element and a torsion guide wire, wherein the scoring element is provided on the outer wall of the balloon body and is arranged along a direction parallel to the axial direction of the balloon body, and the torsion guide wire is located in an intermediate 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 an intermediate layer, outer wall, or inner wall of the outer tube, and the scoring element is located on the same radial cross section as the torsion guide wire.

[0009] Optionally, in the scoring balloon catheter, the scoring members are plural, The torsional guide wires may be a plurality of wires corresponding one-to-one to the scoring elements, or the number of torsional guide wires may be one or more, and each torsional guide wire may correspond one-to-one to some of the scoring elements.

[0010] Optionally, the scoring balloon catheter includes at least one development ring at the distal end of the torsional guidewire; and / or the scoring member is provided with at least one development ring; And / or, at least one development ring is provided in the inner tube corresponding to the scoring member.

[0011] Optionally, in the scoring balloon catheter, the torsional guidewire is a variable diameter guidewire, the diameter of which gradually decreases from the proximal end to the distal end.

[0012] Optionally, in the scoring balloon catheter, the scoring member has a rack structure in which the surface opposite to the balloon body is sawtoothed.

[0013] Optionally, in the above scoring balloon catheter, the cross section of the scoring member is L-shaped, and / or the surface of the scoring member facing the balloon body has multiple engagement grooves opened at intervals, and the engagement grooves are used to adhere to the balloon body with an adhesive.

[0014] Optionally, in the scoring balloon catheter, the scoring member has a fold point in the longitudinal direction, and the thickness of the scoring member at the fold point is smaller than the thickness at a point where no fold point is provided.

[0015] Optionally, in the scoring balloon catheter, the scoring member is a coil spring structure.

[0016] Optionally, in the scoring balloon catheter, when the torsional guide wire is located in an intermediate layer, an outer wall, or an inner wall of the inner tube, the torsional guide wire is integrally formed with or bonded to the inner tube; When the torsional guide wire is located in an intermediate layer, an outer wall, or an inner wall of the outer tube, the torsional guide wire is integrally formed with or bonded to the outer tube; When the torsional guide wire is positioned between the inner tube and the outer tube, both ends of the torsional guide wire are connected to the balloon body and the catheter holder, respectively, and a part or all of the torsional guide wire is connected to the outer wall of the inner tube.

[0017] Optionally, in the scoring balloon catheter, the balloon body has a cylindrical structure in the middle and conical structures at both ends, the cylindrical structure in the middle being a working segment, and the conical structures at both ends being non-working segments; the scoring member is provided on the intermediate cylindrical structure of the balloon body; When there are a plurality of scoring members, the scoring members are provided evenly around the circumference of the outer surface of the balloon body.

[0018] The present application provides a scoring balloon catheter, the beneficial effects of which are as follows:

[0019] By providing a twisted guidewire on 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 twisted guidewire is located on the same radial cross section as the scoring element, accurate alignment of the scoring element with the lesion can be effectively achieved. The scoring element then cuts the lesion in a directional manner, significantly improving the vascular stenosis and dilation effect during angioplasty. Furthermore, various structural designs of the scoring element can be implemented, resulting in excellent flexibility.

[0020] In order to more clearly explain the technical solutions of the embodiments of the present application or the prior art, the drawings that need to be used in the description of the embodiments or the prior art will be briefly described below. It should be apparent that the drawings described below are only embodiments of the present application, and those skilled in the art can also obtain other drawings based on these drawings without any creative work. [Brief explanation of the drawings]

[0021] [Figure 1]1 is a structural schematic diagram of a scoring balloon catheter according to an embodiment of the present application. FIG. [Figure 2] FIG. 2 is a partial enlarged view of part A in FIG. [Figure 3] FIG. 3 is a partial cross-sectional view of FIG. 2. [Figure 4] FIG. 4 is a partial enlarged view of part B in FIG. [Figure 5] FIG. 4 is a cross-sectional view of a CC portion in FIG. [Figure 6] 1 is a structural schematic diagram of a variable diameter guidewire according to an embodiment of the present application. [Figure 7] FIG. 2 is a schematic structural diagram of the bottom of a first scoring member according to an embodiment of the present application before being folded. [Figure 8] FIG. 8 is a partial enlarged view of part D in FIG. 7. [Figure 9] FIG. 2 is a schematic diagram of a partial structure of the bottom of a first scoring member according to an embodiment of the present application after being folded. [Figure 10] 1 is a cross-sectional view of a first scoring member according to an embodiment of the present application. [Figure 11] FIG. 2 is a structural schematic diagram of a second scoring member according to an embodiment of the present application. [Figure 12] FIG. 12 is a partially enlarged view of a portion E in FIG. [Figure 13] FIG. 10 is a structural schematic diagram of a fourth scoring member according to an embodiment of the present application. [Figure 14] FIG. 14 is a partial enlarged view of part F in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0022] Hereinafter, the embodiments of the present application will be described in detail, and the embodiments are illustrated in the drawings, wherein the same or similar reference numerals throughout the specification 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 merely illustrative and are used only to interpret the present application, and do not limit the present application.

[0023] It should be understood that, in the present description, the terms "proximal end" and "distal end" as used throughout the specification refer to proximal and distal ends relative to the operator, and that, as used herein, the end closest to the physician or operator is the "proximal end," i.e., the end where the operator is located, and the end away from the physician or operator is the "distal end," i.e., the end where the balloon is located. It should be understood that the orientation descriptions referred to above are for convenience and simplicity of explanation only, and do not limit the present application in any way by indicating or implying that such devices or elements necessarily have a particular orientation or are configured and operated in a particular orientation.

[0024] The core of the present application 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] In order to enable those skilled in the art to better understand the technical solution of the present application, the present application will be further described in detail below with reference to the drawings and specific embodiments.

[0026] 1 to 14, the examples of the present application disclose a scoring balloon catheter, which includes a catheter holder 5, an inner tube 3, an outer tube 4, a balloon body 1, a scoring member 2, and a torsional guide wire 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 is provided with a balloon pressurization / depressurization port 502 and a guidewire guide port 501 .

[0028] An outer tube 4 is fitted onto the outside of the inner tube 3; specifically, a terminal tube, balloon body 1, and outer tube 4 are fitted into the inner tube 3 in this order 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, a guidewire is guided from the terminal tube to enter the guidewire cavity a of the scoring balloon catheter and is then withdrawn from the body via the guidewire guide port 501. Guiding the guidewire can assist in the delivery of an interventional device 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 fill the balloon body 1 to expand it or depressurize it to contract it.

[0030] The scoring member 2 is a member that cuts the lesion location, and is specifically provided on the outer wall of the balloon body 1 and arranged along the axial direction of the balloon body 1. In order to address the problem that scoring balloons in the prior art are unable to effectively and accurately align the scoring member 2 with the lesion location, a twisted guide wire 6 is additionally provided.

[0031] Specifically, the torsion guide wire 6 may be disposed on an intermediate layer, outer wall, or inner wall of the inner tube 3, or, if necessary, between the inner tube 3 and the outer tube 4, or, further, on an intermediate layer, outer wall, or inner wall of the outer tube 4. Those skilled in the art can select the location of the torsion guide wire 6 according to actual needs, and the specific location of the torsion guide wire 6 is not limited in this embodiment.

[0032] The scoring element 2 should be positioned on the same radial cross section as the torsion guide wire 6, so that the position of the scoring element 2 can be determined by observing the position of the torsion guide wire 6; the torsion guide wire 6 can also improve the torsional strength of the scoring balloon catheter, so that by twisting the catheter holder 5, torque can be transmitted from the torsion guide wire 6 to the balloon body 1, thereby twisting the scoring element 2 directionally and accurately aligning the lesion position to be cut.

[0033] Furthermore, when the torsion guidewire 6 is disposed 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, and the torsion guidewire 6 can extend into 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 located and the other end extending to the proximal end of the balloon body 1, so that by twisting the catheter holder 5, the balloon body 1 can be rotated accordingly under the action of 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 a portion or the entire torsion guidewire 6 must be connected to the outer wall of the inner tube 3 (i.e., the middle portion of the torsion guidewire 6 must also be fixed; for example, the entire torsion guidewire 6 may be fixed to the outer wall of the inner tube, or a portion or multiple spaced portions of the torsion guidewire 6 may be fixed to the outer wall of the inner tube).

[0034] When the twisting guide wire 6 is provided in the inner tube 3, it may be connected to the inner wall or outer wall of the inner tube 3 (the two may be an integrally molded structure or may be connected by adhesive, etc.), or the twisting guide wire 6 may be provided in the middle layer of the inner tube 3 (i.e., the twisting guide wire 6 is provided between the outer wall and inner wall of the inner tube 3, thereby imparting a torque transmission function to the inner tube 3).

[0035] When the twisted guide wire 6 is provided in the outer tube 4, it may be connected to the inner wall or outer wall of the outer tube 4 (the two may be an integrally molded structure or may be connected by adhesive or the like), or it may be located in an intermediate layer of the outer tube 4 (i.e., the twisted guide wire 6 is provided between the outer wall and inner wall of the outer tube 4, thereby imparting a torque transmission function to the outer tube 4).

[0036] As described above, the scoring balloon catheter of the present application has a torsion guide wire 6 installed in either the inner tube 3 or the 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, because the torsion guide wire 6 is located on the same radial cross section as the scoring element 2, the position of the torsion guide wire 6 can be observed at the proximal end to determine the position of the scoring element 2. This effectively achieves accurate alignment between the scoring element 2 and the lesion position, and the scoring element 2 can directionally cut the lesion, significantly improving the effect of stenosis and dilation of the blood vessel during angioplasty.

[0037] When there is one scoring element 2, there is also one corresponding tortuosity guide wire 6. When there are multiple scoring elements 2, the multiple scoring elements 2 are distributed circumferentially around the balloon body 1. In one embodiment, there are multiple tortuosity guide wires 6 that correspond one-to-one to the scoring elements 2, i.e., the tortuosity guide wires 6 and the scoring elements 2 are the same in number and correspond in position. In another embodiment, there are multiple tortuosity guide wires 6, and the tortuosity guide wires 6 correspond one-to-one to some of the scoring elements 2. In other words, the number of tortuosity guide wires 6 is smaller than the number of scoring elements 2. In this case, the tortuosity guide wires 6 can achieve a positional correspondence with some of the scoring elements 2 according to predetermined conditions, which may be a method that facilitates positional relationships or operation, etc. For example, if there are four scoring elements 2, one scoring element 2 is arranged at 90° intervals around the circumference of the balloon body 1. In this embodiment, only two torsion guidewires 6 may be arranged, and these two torsion guidewires 6 may correspond to two of the scoring elements 2, respectively. For example, one of the torsion guidewires 6 may correspond to one of the scoring elements 2, and after a 180° interval, the other torsion guidewire 6 may correspond to the other scoring element 2. The operator can unambiguously predict that there will still be a corresponding scoring element 2 at the midpoint between the two torsion guidewires 6. That is, even if there is no torsion guidewire 6, the position of the scoring element 2 can be determined by reasonable prediction.

[0038] The torsional guide wire 6 and the scoring members 2 of the balloon body 1 are positioned in a straight line and correspond one-to-one, and the torsional guide wire 6 may be one or more, depending on the number of scoring members 2.

[0039] In a specific embodiment, the torsion guidewire 6 may be made of a metallic material with excellent torque transmission characteristics, and the outer tube 4 may be made of a transparent material. Because the outer tube 4 is transparent, when the torsion guidewire 6 is disposed in the outer tube 4 or between the inner tube 3 and the outer tube 4, the operator can visualize the torsion guidewire 6 at its proximal end. When the torsion guidewire 6 is disposed on the inner wall or intermediate layer of the inner tube 3, the inner tube 3 may also be designed as a transparent material to enable observation of the torsion guidewire 6. Of course, by marking the position of the torsion guidewire 6 on the proximal end of the outer tube 4, observation of the torsion guidewire 6 may also be achieved without designing the outer tube 4 as a transparent material.

[0040] Furthermore, to more intuitively identify the position of the scoring element 2, at least one development ring 7 is provided at the distal end of the torsion guide wire 6. The development ring 7 is used to indicate the position of the torsion guide wire 6 within the patient's body. Because the torsion guide wire 6 and the scoring element 2 are located on the same straight line, the operator can further identify the position of the scoring element 2 by observing the position of the torsion guide wire 6. At least one development ring 7 is provided on the scoring element 2, and / or at least one development ring 7 is provided on the inner tube 3 corresponding to the scoring element 2. That is, a development ring 7 may be provided at any of the three positions: the torsion guide wire 6, the scoring element 2, and the inner tube 3 corresponding to the scoring element 2, or a development ring 7 may be provided at only a selected portion of these positions. In this embodiment, the specific position of the development ring 7 is not limited, as long as it can indicate the position of the scoring element 2.

[0041] When using the scoring balloon catheter disclosed in the examples of the present 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, the outer tube 4 and the inner tube 3 are rotated in unison, and then the balloon body 1 and the scoring member 2 are rotated in unison. The position of the torsion guide wire 6 is observed, and the torsion guide wire 6 is rotated until it is positioned on the same radial cross section as the lesion. Since the torsion guide wire 6 is positioned on the same radial cross section as the scoring member 2, at this time the scoring member 2 is aligned with the lesion. Then, the balloon body 1 is filled and inflated through the balloon filling cavity b by the balloon pressurization / decompression port 502, and the scoring member 2 comes into contact with the lesion and cuts it in a direction.

[0042] Based on the above specific implementation, the torsional guidewire 6 may be a variable diameter guidewire, the diameter of which 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 the torsional guidewire 6 being a variable diameter torsional member include the fact that the larger diameter at the proximal end allows the torsional guidewire 6 to fulfill torque transmission functions, and the smaller diameter at the distal end provides the distal end with 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 and manufacturing costs, and improving the performance and economy of the mechanical design.

[0043] Specifically, the balloon body 1 has a cylindrical middle and conical ends. The cylindrical middle is the working segment, i.e., the part that exerts the vasodilatory effect, and 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 can be used to position the balloon body 1 at the lesion location.

[0044] The diameter of the balloon body 1 is 1.0 mm to 40.0 mm, and the 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 may include one or more of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or other polymeric materials with excellent biocompatibility. The material of the balloon body 1 may be the same as that 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 based on actual needs.

[0046] The scoring members 2 may be fixed to the surface of the intermediate cylindrical structure of the balloon body 1, and are arranged in a direction parallel to the axial direction of the balloon body 1, and are typically fixed by bonding with an adhesive. The number of scoring members 2 is n, where n is an integer greater than or equal to 1. When there are multiple scoring members 2, they may be evenly spaced 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. Alternatively, 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 improved in structure so that various design forms can be adopted as follows according to actual needs.

[0048] In the first embodiment, the scoring member 2 has a rack structure in which the surface opposite the balloon body 1 is sawtoothed. As shown in FIGS. 7 and 8, the surface of the scoring member 2 opposite the balloon body 1 is sawtoothed, and the sawtooth structure consists of multiple teeth spaced apart. By adopting this structure, the flexibility of the scoring member 2 can be improved, allowing it to more easily pass through tortuous blood vessels. Grooves are formed between adjacent teeth, and the groove width may be 0.05 mm to 0.2 mm, the groove depth may be 0.05 mm to 0.4 mm, and the groove spacing may be 0.1 mm to 2 mm. Those skilled in the art will understand that the provision of grooves increases the flexibility of the scoring member 2, thereby providing space for the teeth to displace when the scoring member 2 deforms. Furthermore, since the grooves have a certain depth, the thickness corresponding to the grooved portions is thin, making them more susceptible to deformation, allowing the scoring member 2 to more easily pass through tortuous blood vessels. The width and depth of the grooves can be set as needed.

[0049] The cross section of the scoring member 2 is L-shaped; that is, as shown in Figures 7 and 8, it is folded at a position approximately 0.1 mm to 0.2 mm from the bottom of the scoring member 2, forming an "L"-shaped folded structure as 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, thereby increasing the contact area between the scoring member 2 and the surface of the balloon body 1 and enabling the scoring member 2 to be more firmly adhered to the surface of the balloon body 1.

[0050] In a second embodiment, the surface of the scoring member 2 opposite the balloon body 1 is sawtoothed, with the sawtooth structure consisting of multiple teeth spaced apart, and employing such a structure improves the flexibility of the scoring member 2, making it easier to pass through tortuous blood vessels. Grooves are formed between adjacent teeth, and the groove depth may be 0.2 mm to 0.5 mm, the groove width may be 0.05 mm to 0.2 mm, the groove depth may be 0.05 mm to 0.3 mm, and the groove spacing may be 0.1 mm to 2 mm.

[0051] The scoring member 2 has a surface facing the balloon body 1 with a plurality of spaced engagement grooves for bonding to the balloon body 1 with an adhesive. As shown in Figures 11 and 12, the engagement grooves may be T-shaped holes. The bottom of the scoring member 2 has a plurality of T-shaped holes spaced apart. The T-shaped holes should be positioned to correspond to the teeth between the grooves. That is, the T-shaped holes should avoid the grooves in the height direction to prevent the grooves from being too thin at their bottoms, which would compromise the strength of the scoring member 2. Because the T-shaped holes are located on the side facing the balloon body 1, the adhesive can enter the T-shaped holes during adhesive bonding. After the adhesive hardens, the hardened adhesive and the scoring member 2 form a physical engagement structure, resulting in a stronger bond than the first type bond formed solely with adhesive.

[0052] Based on the first form, a third form (not shown) can be designed to further increase the flexibility of the scoring member 2, in which the scoring member 2 has a bar structure with a sawtooth surface on the side opposite to the balloon body 1, and is folded at the base of the scoring member 2 to form an "L"-shaped folded structure. In addition, the scoring member 2 has fold points along its length, and the thickness of the scoring member 2 at the fold points is smaller than the thickness at the points where no fold points are provided.

[0053] Similarly, a fourth embodiment can be designed based on the second embodiment, in which the scoring member 2 has a bar structure with a sawtooth surface on the side opposite the balloon body 1, and the surface of the scoring member 2 facing the balloon body 1 has a plurality of engagement grooves opened at intervals, which are used for bonding to the balloon body 1 with an adhesive. In addition, the scoring member 2 has fold points along its length, and the thickness of the scoring member 2 at the fold points is smaller than the thickness of the portions where there are no fold points.

[0054] 13 and 14 , several folding points are added to the middle portion of the scoring member 2, and the thickness at the folding points may be 1 / 4 to 3 / 4 of the thickness at other positions of the scoring member 2. Multiple folding points may be provided along the length of the scoring member 2, and the spacing between two adjacent folding points may be designed to be 1 mm to 10 mm, with the specific spacing dimension being selected depending on the overall length of the scoring member 2. In this embodiment, the folding point design can increase the flexibility of the scoring member 2, and the folding points and sawtooth structure can increase the bending ability of the scoring member 2 in different directions, improving its passability through tortuous blood vessels.

[0055] Based on the above-mentioned first, second, third and fourth embodiments, both ends of the scoring member 2 can be designed in an arc shape to prevent scratching of the blood vessel. The scoring member 2 can be made of a metal plate material such as stainless steel, and the grooves and engagement grooves 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 rectangular wire, and after winding, the cross section of the scoring member 2 is an isosceles triangle (with the apex angle smaller than 60 degrees) (the cross section may have other polygonal structures). When the scoring member 2 is wound with nickel-titanium rectangular wire, the spacing may be 0 to 0.076 mm, although this is not shown. This structure also enhances the flexibility of the scoring member 2, and the scoring member 2 is made of a nickel-titanium alloy, which has good shape memory properties.

[0057] As described above, the scoring balloon catheter disclosed in the examples of the present application has the following beneficial effects.

[0058] 1) By providing a variable diameter guide wire for transmitting torque between the inner tube 3 and the outer tube 4, 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 element 2, the position of the scoring element 2 can be obtained by observing the position of the variable diameter guide wire, thereby achieving the purpose of directional cutting.

[0060] 3) The scoring member 2 has excellent flexibility so as to adapt to tortuous blood vessels due to various structural designs.

[0061] As used herein and in the claims, words such as "a," "one," "an," "one kind," and / or "the" do not refer to the singular but may also include the plural, unless the context clearly indicates otherwise. In general, the terms "comprise" and "comprising" refer only to the inclusion of explicitly recited steps and elements, and these steps and elements do not constitute an exclusive list; a method or apparatus may also include other steps or elements. An element qualified by the phrase "comprising a..." does not exclude the presence of other identical elements in the process, method, product, or apparatus that includes the element.

[0062] Here, in the description of the examples of the present 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 and indicates three types of relationships, for example, A and / or B can indicate three cases: the presence of only A, the presence of both A and B, and the presence of only B. Also, in the description of the examples of the present application, "plurality" means two or more.

[0063] In the description of this application, unless otherwise expressly limited, the words "provide," "attach," "connect," etc. should be understood in a broad sense, and those skilled in the art can properly determine the specific meaning of the above words in this application by referring to the specific content of the technical solution.

[0064] Each embodiment in this specification is described in a step-by-step manner, with each embodiment focusing on the differences from other embodiments, and the same or similar parts of each embodiment may be referred to each other.

[0065] Although the present specification uses specific examples to explain the principles and embodiments of the present application, the explanation of the above examples is only used to help understand the method and core idea of the present application. It should be noted that those skilled in the art can make various improvements and modifications to the present application without departing from the principles of the present application, 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 member; 3 - inner tube; 4 - outer tube; 5 - catheter holder; 501 - guidewire guide port; 502 - balloon pressure / decompression port; 6 - twisted guidewire; 7 - development ring; a - guidewire cavity; b - balloon filling cavity

Claims

1. A scoring balloon catheter comprising a catheter holder (5), an inner tube (3), an outer tube (4), and a balloon body (1), the outer tube (4) being fitted onto the outside of the inner tube (3), the outer tube (4) being connected at its proximal end to the catheter holder (5) and at its distal end to the balloon body (1); A scoring balloon catheter further comprising a scoring element (2) and a torsion guide wire (6), wherein the scoring element (2) is provided on the outer wall of the balloon body (1) and is arranged along a direction parallel to the axial direction of the balloon body (1), and the torsion guide wire (6) is located in an intermediate 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 an intermediate layer, outer wall, or inner wall of the outer tube (4), and the scoring element (2) is located on the same radial cross section as the torsion guide wire (6).

2. The scoring member (2) is plural, The scoring balloon catheter of claim 1, characterized in that the torsional guide wires (6) are multiple and correspond one-to-one to the scoring members (2), or the number of torsional guide wires (6) is one or multiple, and the torsional guide wires (6) correspond one-to-one to some of the scoring members (2).

3. At least one development ring (7) is provided at the distal end of the torsion guide wire (6), and / or the scoring member (2) is provided with at least one development ring (7); The scoring balloon catheter according to claim 1, characterized in that the inner tube (3) corresponding to the scoring member (2) is provided with at least one development ring (7).

4. 2. The scoring balloon catheter of claim 1, wherein the twisted guidewire (6) is a variable diameter guidewire, the diameter of which gradually decreases from the proximal end to the distal end.

5. A scoring balloon catheter according to any one of claims 1 to 4, characterized in that the scoring member (2) has a rack structure in which the surface opposite the balloon body (1) is sawtoothed.

6. 6. A scoring balloon catheter as described in claim 5, characterized in that the cross section of the scoring member (2) is L-shaped, and / or the surface of the scoring member (2) facing the balloon body (1) has a plurality of engagement grooves opened at intervals, and the engagement grooves are used to adhere to the balloon body (1) with an adhesive.

7. 6. The scoring balloon catheter according to claim 5, characterized in that the scoring member (2) has a fold point in the longitudinal direction, and the thickness of the scoring member (2) at the fold point is smaller than the thickness at the point where the fold point is not provided.

8. 5. The scoring balloon catheter according to claim 1, wherein the scoring member (2) has a coil spring structure.

9. When the torsional guide wire (6) is located in the intermediate layer, outer wall or inner wall of the inner tube (3), the torsional guide wire (6) is integrally formed with or bonded to the inner tube (3); When the torsional guide wire (6) is located in the intermediate layer, outer wall or inner wall of the outer tube (4), the torsional guide wire (6) is integrally formed with or bonded to the outer tube (4); The scoring balloon catheter of claim 1, characterized in that when the torsion guide wire (6) is positioned 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).

10. The balloon body (1) has a cylindrical structure in the middle and conical structures at both ends, the cylindrical structure in the middle being a working segment, and the conical structures at both ends being non-working segments; The scoring member (2) is provided in the middle cylindrical structure of the balloon body (1), The scoring balloon catheter according to claim 1, characterized in that when there are multiple scoring members (2), the multiple scoring members (2) are evenly arranged circumferentially on the outer surface of the balloon body (1).

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