Scoring balloon catheter

Abstract

Provided in the present application is a scoring balloon catheter, comprising a catheter holder, an inner tube, an outer tube, a balloon body, a scoring member, and a torsion guidewire, wherein the outer tube is sleeved on the outer side of the inner tube; a proximal end of the outer tube is connected to the catheter holder, and a distal end of the outer tube is connected to the balloon body; the scoring member is arranged on the outer wall of the balloon body in an axial direction; and two ends of the torsion guidewire are connected to the balloon body and the catheter holder, respectively, and the torsion guidewire is located on the inner tube, or is located between the inner tube and the outer tube, or is located on the outer tube, with the scoring member and the torsion guidewire being located on the same radial section. In the present application, the torsion guidewire is provided on the inner tube or on the outer tube or between the inner tube and the outer tube, such that the torque of the catheter holder can be transmitted to the balloon body; and because the torsion guidewire and the scoring member are located on the same radial section, accurate alignment of the scoring member and the site of a lesion can be effectively achieved, and the scoring member directionally cuts the lesion, thereby greatly improving the vascular stenosis dilating effect during an angioplasty. In addition, the scoring member is subjected to various structural designs, such that the scoring member has a good flexibility.

Description

A scored balloon catheter

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the Patent Office of China on April 28, 2024, with application number 202410519258.6 and invention name “A Score Balloon Catheter”, the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application belongs to the field of medical device technology, and in particular relates to a scored balloon catheter. Background Art

[0004] For many years, blocked arteries have become a major medical problem. This is because blocked arteries reduce blood flow through them, leading to a variety of serious complications. Arterial narrowing is primarily caused by the accumulation of cholesterol, calcium, and fibrotic tissue, and angioplasty is perhaps the most commonly used treatment. Angioplasty involves using an inflatable balloon to dilate the blocked artery, but this treatment option is associated with a high rate of restenosis.

[0005] To solve the above problems, scored balloons have emerged. The scored parts on the balloons can cut stenosis during angioplasty to enhance the efficacy of stenosis expansion.

[0006] However, most arterial stenosis forms as eccentric lesions, that is, the lesions do not completely extend around the circumference of the affected body blood vessel. This results in the inability of existing scored balloons to effectively align the scoring member with the lesion location, and the dilation effect on eccentric lesion stenosis is poor.

[0007] Therefore, how to achieve accurate alignment of the scoring member with the lesion position to achieve a better stenosis dilation effect is an urgent problem to be solved by those skilled in the art.

[0008] Summary of the Invention

[0009] The purpose of the present application is to provide a scored balloon catheter that can effectively achieve precise alignment of the scoring member with the lesion position, thereby achieving a better stenosis dilation effect.

[0010] To solve the above technical problems, the present application provides a scoring balloon catheter, comprising: a catheter seat, an inner tube, an outer tube and a balloon body, wherein the outer tube is sheathed on the outer side of the inner tube, the proximal end of the outer tube is connected to the catheter seat, and the distal end is connected to the balloon body;

[0011] It also includes: a scoring piece and a torsion guidewire, the scoring piece is arranged on the outer wall of the balloon body and arranged along the axial direction parallel to the balloon body, the torsion guidewire is located on the middle interlayer, outer wall or inner wall of the inner tube, or, the torsion guidewire is located between the inner tube and the outer tube, or, the torsion guidewire is located on the middle interlayer, outer wall or inner wall of the outer tube, and the scoring piece and the torsion guidewire are located on the same radial section.

[0012] Optionally, in the above-mentioned scored balloon catheter, there are multiple scoring members;

[0013] The twist guide wires are multiple and correspond one-to-one with the scoring members, or the number of the twist guide wires is one or more and the twist guide wires correspond one-to-one with some of the scoring members.

[0014] Optionally, in the above-mentioned scored balloon catheter, the distal end of the torsion guidewire is provided with at least one developing ring;

[0015] and / or, at least one developing ring is provided on the scoring member;

[0016] And / or, at least one developing ring is provided on the inner tube corresponding to the scoring member.

[0017] Optionally, in the above-mentioned scored balloon catheter, 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.

[0018] Optionally, in the above-mentioned scored balloon catheter, the scoring member is a rack structure with a serrated surface on the side facing away from the balloon body.

[0019] Optionally, in the above-mentioned scored balloon catheter, the cross-section of the scored member is L-shaped, and / or a plurality of slots are provided at intervals on a surface of the scored member facing the balloon body, and the slots are used to bond to the balloon body by glue.

[0020] Optionally, in the above-mentioned scored balloon catheter, the scored member is provided with a breaking point in the length direction, and the thickness of the scored member at the breaking point is less than the thickness at a position without the breaking point.

[0021] Optionally, in the above-mentioned scored balloon catheter, the scoring member is a coil spring structure.

[0022] Optionally, in the above-mentioned scored balloon catheter, when the torsion guidewire is located on the middle interlayer, outer wall or inner wall of the inner tube, the torsion guidewire and the inner tube are an integrally formed structure or bonded;

[0023] When the torsion guidewire is located on the middle interlayer, outer side wall or inner side wall of the outer tube, the torsion guidewire and the outer tube are an integrally formed structure or bonded;

[0024] When the torsion guidewire is located between the inner tube and the outer tube, both ends of the torsion guidewire are respectively connected to the balloon body and the catheter seat, and part or the whole of the torsion guidewire is connected to the outer side wall of the inner tube.

[0025] Optionally, in the above-mentioned scored balloon catheter, the balloon body is a structure with a middle cylinder and two tapered ends, the middle cylindrical structure is a working section, and the two tapered ends are non-working sections;

[0026] The scoring member is provided on the middle cylindrical structure of the balloon body;

[0027] When there are multiple scoring elements, the multiple scoring elements are evenly arranged in the circumferential direction of the outer surface of the balloon body.

[0028] The present application provides a scored balloon catheter, which has the following beneficial effects:

[0029] By placing a torsion guidewire on the inner or outer tube, or between the inner and outer tubes, the torque of the catheter hub can be transmitted to the balloon body. Because the torsion guidewire and the scoring element are located on the same radial plane, the scoring element can be precisely aligned with the lesion, allowing the scoring element to cut the lesion in a targeted manner, significantly improving the dilation and stenosis effect during angioplasty. Furthermore, the scoring element features a variety of structural designs, making it highly flexible. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without any creative work.

[0031] FIG1 is a schematic structural diagram of a scored balloon catheter provided in an embodiment of the present application;

[0032] FIG2 is a partial enlarged view of point A in FIG1;

[0033] FIG3 is a partial cross-sectional view of FIG2;

[0034] FIG4 is a partial enlarged view of point B in FIG3;

[0035] FIG5 is a cross-sectional view taken at CC in FIG3 ;

[0036] FIG6 is a schematic structural diagram of a variable diameter guidewire provided in an embodiment of the present application;

[0037] FIG7 is a schematic structural diagram of the bottom of the first scoring member provided in an embodiment of the present application before bending;

[0038] FIG8 is a partial enlarged view of point D in FIG7;

[0039] FIG9 is a schematic diagram of a partial structure of the bottom of the first scoring member provided in an embodiment of the present application after bending;

[0040] FIG10 is a cross-sectional view of a first scoring member provided in an embodiment of the present application;

[0041] FIG11 is a schematic structural diagram of a second scoring member provided in an embodiment of the present application;

[0042] FIG12 is a partial enlarged view of FIG11 at point E;

[0043] FIG13 is a schematic structural diagram of a fourth scoring member provided in an embodiment of the present application;

[0044] FIG14 is a partial enlarged view of point F in FIG13 .

[0045] In the above drawings:

[0046] 1-Balloon body; 2-Scoring piece; 3-Inner tube; 4-Outer tube; 5-Catheter seat; 501-Guidewire guide port; 502-Balloon inflation and decompression port; 6-Torsion guidewire; 7-Developing ring;

[0047] a-guidewire lumen; b-balloon filling lumen. DETAILED DESCRIPTION

[0048] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0049] Throughout the description of this application, it should be understood that the terms "proximal" and "distal" refer to the near and far ends relative to the operator. In this application, 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. The above-mentioned descriptions of orientations are merely for the purpose of facilitating the description of this application and simplifying the description. They are not intended to indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation, and are therefore not to be construed as limiting this application.

[0050] The core of this application is to provide a scored balloon catheter that can effectively achieve precise alignment of the scoring component with the lesion position, thereby achieving a better stenosis dilation effect.

[0051] In order to enable those skilled in the art to better understand the technical solutions provided by this application, this application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0052] Specifically, referring to Figures 1-14, the present invention discloses a scoring balloon catheter. In this embodiment, the scoring balloon catheter includes a catheter hub 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 can be provided at the distal end of the balloon body 1 as needed.

[0053] The catheter seat 5 is a hollow structure, and is provided with a balloon inflation and decompression interface 502 and a guidewire guide port 501 .

[0054] The outer tube 4 is sheathed around the inner tube 3. Specifically, the inner tube 3 sheathes, from distal to proximal, the terminal tube, the balloon body 1, and the outer tube 4. The inner lumen of the inner tube 3 serves as a guidewire lumen a, which communicates with the guidewire introduction port 501. During use, a guidewire passes from the terminal tube into the guidewire lumen a of the scored balloon catheter and is then guided out of the body through the guidewire introduction port 501. This guidewire facilitates the delivery of interventional devices using the scored balloon catheter.

[0055] The proximal end of the outer tube 4 is connected to the catheter seat 5, and the distal end of the outer tube 4 is provided with a balloon body 1. 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 filling and decompression interface 502 is connected to the inner cavity of the balloon body 1 through the balloon filling cavity b, and is used to fill and expand or decompress and contract the balloon body 1.

[0056] Scoring element 2, as a component for cutting the lesion, is specifically provided on the outer wall of balloon body 1 and arranged along the axial direction of balloon body 1. To address the problem that the scoring balloon in the prior art cannot effectively align the scoring element 2 with the lesion, a torsion guide wire 6 is additionally provided.

[0057] Specifically, the torsion guide wire 6 can be disposed in the middle layer, outer wall, or inner wall of the inner tube 3; or, depending on the needs, the torsion guide wire 6 can be disposed between the inner tube 3 and the outer tube 4; or, depending on the needs, the torsion guide wire 6 can be disposed in the middle layer, outer wall, or inner wall of the outer tube 4. It should be noted that those skilled in the art can select the location of the torsion guide wire 6 according to actual needs, and this embodiment does not limit the specific location of the torsion guide wire 6.

[0058] The scoring piece 2 should be located on the same radial section as the torsion guide wire 6, so that the position of the scoring piece 2 can be determined by observing the position of the torsion guide wire 6. In addition, the torsion guide wire 6 can also increase the torsion resistance of the scoring balloon catheter, so that the torque can be transmitted from the torsion guide wire 6 to the balloon body 1 through the torsion catheter seat 5, so that the scoring piece 2 can be twisted in a direction and accurately aligned with the lesion position to be cut.

[0059] It should be noted that when the torsion guidewire 6 is arranged 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 proximal torque to the balloon body 1. The torsion guidewire 6 extends in the space between the outer tube 4 and the inner tube 3, with one end located on the side where the catheter seat 5 is located, and the other end can extend to the proximal end of the balloon body 1, so that by twisting the catheter seat 5, the balloon body 1 can be rotated under the action of the torque transmitted by the torsion guidewire 6. Both ends of the torsion guidewire 6 need to be fixed to the inner tube 3 and the outer tube 4 respectively, and part or the whole of the torsion guidewire 6 needs to be connected to the outer wall of the inner tube 3 (that is, the middle part of the torsion guidewire 6 also needs to be fixed, such as the whole of the torsion guidewire 6 is fixed on the outer wall of the inner tube, or a part or multiple spaced parts of the torsion guidewire 6 are fixed on the outer wall of the inner tube).

[0060] When the torsion guide wire 6 is arranged on the inner tube 3, it can be specifically connected to the inner wall or outer wall of the inner tube 3 (the two can be an integrally formed structure or connected by bonding, etc.), or the torsion guide wire 6 can be arranged in the middle layer of the inner tube 3 (that is, the torsion guide wire 6 is arranged between the outer wall and the inner wall of the inner tube 3, so that the inner tube 3 has the function of transmitting torque).

[0061] When the torsion guide wire 6 is arranged on the outer tube 4, it can be specifically connected to the inner wall or outer wall of the outer tube 4 (the two can be an integrally formed structure or connected by bonding, etc.), or located in the middle layer of the outer tube 4 (that is, the torsion guide wire 6 is arranged between the outer wall and the inner wall of the outer tube 4, so that the outer tube 4 has the function of transmitting torque).

[0062] In summary, the scored balloon catheter provided by the present application can transmit the torque of the catheter seat 5 to the balloon body 1 by arranging a torsion guidewire 6 on the inner tube 3 or the outer tube 4, or between the inner tube 3 and the outer tube 4. Since the torsion guidewire 6 and the scoring part 2 are located on the same radial section, the position of the scoring part 2 can be judged by observing the position of the torsion guidewire 6 at the proximal end, thereby effectively achieving precise alignment of the scoring part 2 with the lesion position, and the scoring part 2 directionally cuts the lesion, greatly improving the effect of vascular stenosis and dilation during angioplasty.

[0063] When the number of notch members 2 is one, the number of torsion guidewires 6 is also one. When the number of notch members 2 is multiple, the multiple notch members 2 are distributed circumferentially on the balloon body 1. In one form, the torsion guidewires 6 are multiple and correspond one to one with the notch members 2, that is, the number of torsion guidewires 6 and the notch members 2 is the same, and the positions correspond. In another form, the number of torsion guidewires 6 is multiple, and the torsion guidewires 6 correspond one to one with some of the notch members 2. That is, if the number of torsion guidewires 6 is less than the number of notch members 2, the torsion guidewires 6 can achieve a positional correspondence with some of the notch members 2 according to a preset condition, and the preset condition can be a positional relationship or a method that is conducive to operation, etc. For example, if there are four score elements 2, each spaced 90° apart along the circumference of the balloon body 1, in this embodiment, only two torsion guidewires 6 may be provided, each corresponding to one of the score elements 2. For example, one torsion guidewire 6 may be aligned with one of the score elements 2, and the other torsion guidewire 6, spaced 180° apart, may be aligned with the other score element 2. The operator can directly and unambiguously predict that a corresponding score element 2 will be located midway between the two torsion guidewires 6. This means that, through reasonable prediction, the location of the score element 2 can be determined even without a torsion guidewire 6.

[0064] The torsion guide wire 6 and the scoring piece 2 on the balloon body 1 are located in a straight line, and the two correspond one to one. There can be one or more torsion guide wires 6, which depends on the number of the scoring pieces 2.

[0065] In a specific embodiment, the torsion guidewire 6 can be made of a metal material with excellent torque transmission capability, and the outer tube 4 can be made of a transparent material. Since the outer tube 4 is transparent, when the torsion guidewire 6 is set on the outer tube 4, or when it is set between the inner tube 3 and the outer tube 4, the operator can see the torsion guidewire 6 at the proximal end with the naked eye. If the torsion guidewire 6 is set on the inner wall or the middle interlayer of the inner tube 3, the torsion guidewire 6 can also be observed by designing the inner tube 3 as a transparent material. Of course, the position of the torsion guidewire 6 can also be marked on the proximal end of the outer tube 4, without designing the outer tube 4 as a transparent material, and the torsion guidewire 6 can also be observed.

[0066] Furthermore, in order to more intuitively determine 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 display the position of the torsion guide wire 6 in 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 determine the position of the scoring member 2 by observing the position of the torsion guide wire 6. It should be noted that 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, the torsion guide wire 6, the scoring member 2, and the inner tube 3 corresponding to the scoring member 2 can all be provided with developing rings 7, or some of them can be provided with developing rings 7. This embodiment does not limit the specific position of the developing ring 7, as long as it can indicate the position of the scoring member 2.

[0067] When the scoring balloon catheter disclosed in the embodiment of the present application is in use, the balloon body 1 in a contracted state is first delivered to the lesion of the blood vessel. When the position of the scoring member 2 needs to be adjusted, the catheter seat 5 can be rotated to drive the outer tube 4 and the inner tube 3 to rotate, and then drive the balloon body 1 and the scoring member 2 to rotate, and observe the position of the torsion guide wire 6. It is rotated until the torsion guide wire 6 and the lesion position are located on the same radial section. Since the torsion guide wire 6 and the scoring member 2 are located on the same radial section, the scoring member 2 is aligned with the lesion position at this time, and then the balloon body 1 is filled and expanded through the balloon filling cavity b through the balloon filling and decompression interface 502, and the scoring member 2 contacts the lesion and directionally cuts it.

[0068] Based on the above-described specific implementation, the torsion guidewire 6 can be a variable-diameter guidewire, whose diameter gradually decreases from the proximal end (located on the catheter adapter 5 side) to the distal end (located on the balloon body 1 side). The advantages of using the variable-diameter form of the torsion guidewire 6 as a torsion component are: the larger diameter at the proximal end allows the torsion guidewire 6 to meet the torque transmission function, while the smaller diameter at the distal end provides greater flexibility, facilitating its passage through tortuous blood vessels. Furthermore, the thickness of the variable-diameter guidewire can be adjusted according to actual load conditions, thereby improving load-bearing capacity. Furthermore, this can reduce material consumption, lower manufacturing costs, and improve the performance and economic efficiency of the mechanical design.

[0069] Specifically, the balloon body 1 is a cylindrical structure with tapered ends. The central cylindrical structure is the working section, i.e., the portion that dilates blood vessels, while the tapered ends are the non-working sections. A developing ring 7 is provided on the outer surface of the inner tube 3 corresponding to the balloon body 1, which allows the balloon body 1 to be positioned at the lesion site.

[0070] The diameter of the balloon body 1 is 1.0mm-40.0mm, and the length is 10mm-300mm. The specific size of the balloon body 1 can be selected according to the actual application scenario. This embodiment does not limit the diameter and length of the balloon body 1.

[0071] The material of the balloon body 1 includes one or more of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or a polymer material with good biocompatibility. The material of the balloon body 1 can be the same as that commonly used in the prior art, but this embodiment is not the focus of this. Those skilled in the art can select a material that meets their requirements based on actual needs.

[0072] The scoring elements 2 can be fixed to the surface of the central cylindrical structure of the balloon body 1. The scoring elements 2 are arranged in a direction parallel to the axial direction of the balloon body 1 and are typically fixed by gluing. The number of scoring elements 2 is n, where n is an integer greater than or equal to 1. When there are multiple scoring elements 2, they can be evenly arranged around the outer surface of the balloon body 1, with the angle between any two adjacent scoring elements 2 along the circumference being 360° / n. Alternatively, when there are three scoring elements 2, the angle between any two adjacent scoring elements 2 along the circumference is 120°.

[0073] The scoring member 2 can be adaptively improved in structure according to actual needs, and various design forms are adopted as follows.

[0074] In the first form, the scoring member 2 is a rack structure with a serrated surface on the side facing away from the balloon body 1. As shown in Figures 7 and 8, the surface of the scoring member 2 on the side facing away from the balloon body 1 is serrated, and the serrated structure is a plurality of teeth arranged at intervals. With this structure, the flexibility of the scoring member 2 can be improved, making it easier to pass through tortuous blood vessels. Among them, grooves are formed between adjacent teeth. The width of the grooves can be 0.05mm-0.2mm, the depth of the grooves can be 0.05mm-0.4mm, and the spacing between the grooves can be 0.1mm-2mm. It will be understood by those skilled in the art that the provision of the grooves increases the flexibility of the scoring member 2, so that when the scoring member 2 is deformed, the grooves can provide space for the displacement of the teeth. Moreover, since the grooves have a certain depth, the thickness of the portion where the grooves are provided is thinner, making it easier to deform here, making it easier for the scoring member 2 to pass through tortuous blood vessels. The width and depth of the grooves can be set according to requirements.

[0075] The cross-section of the scoring member 2 is L-shaped, that is, as shown in Figures 7 and 8, it is bent at a distance of about 0.1mm-0.2mm from the bottom edge of the scoring member 2 to form an "L"-shaped bending structure as shown in Figures 9 and 10, so that 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, so that the scoring member 2 can be more firmly adhered to the surface of the balloon body 1.

[0076] In the second embodiment, the surface of the scoring element 2 facing away from the balloon body 1 is serrated. This serrated structure comprises multiple teeth spaced apart. This structure improves the compliance of the scoring element 2, making it easier to navigate through tortuous blood vessels. Grooves are formed between adjacent teeth. The depth of the grooves can range from 0.2mm to 0.5mm. The width of the grooves can range from 0.05mm to 0.2mm, the depth can range from 0.05mm to 0.3mm, and the spacing between the grooves can range from 0.1mm to 2mm.

[0077] The surface of the scoring member 2 facing the balloon body 1 is provided with a plurality of slots spaced apart, and the slots are used to bond the scoring member 2 to the balloon body 1 via glue. As shown in Figures 11 and 12, the slots can be T-shaped holes. The scoring member 2 has a plurality of T-shaped holes spaced apart at the bottom. The T-shaped holes should be positioned at positions corresponding to the teeth between the grooves, that is, in the height direction, the T-shaped holes should avoid the positions of the grooves to prevent the bottom thickness of the grooves from being too thin, thereby affecting the strength of the scoring member 2. Because the T-shaped holes are provided on the side facing the balloon body 1, the glue can enter the T-shaped holes when glue is used for bonding. After the glue dries, the dried glue forms a physical snap-fit ​​structure with the scoring member 2, which is more secure than the first form of bonding using glue alone.

[0078] Based on the first design, to further enhance the compliance of the scored element 2, a third design (not shown) can be designed. The scored element 2 is a strip-shaped structure with a serrated surface on the side facing away from the balloon body 1. The bottom edge of the scored element 2 is bent to form an L-shaped structure. Furthermore, the scored element 2 is provided with break points along its length, and the thickness of the scored element 2 at these break points is less than that of the element without break points.

[0079] Similarly, based on the second form, a fourth form can be designed. The scored member 2 is a serrated strip structure on the side facing away from the balloon body 1. The side facing the balloon body 1 is provided with multiple slots spaced apart at intervals. The slots are used to bond the scored member 2 to the balloon body 1 with glue. Furthermore, the scored member 2 is provided with break points along its length, and the thickness of the scored member 2 at these break points is less than that of the member without break points.

[0080] As shown in Figures 13 and 14 , the scoring element 2 has several additional breakpoints in its central portion. The wall thickness at these breakpoints can be one-quarter to three-quarters of the thickness at other locations on the scoring element 2. Multiple breakpoints can be provided along the length of the scoring element 2, and the spacing between two adjacent breakpoints can be designed to be 1 mm to 10 mm. The specific spacing can be selected based on the total length of the scoring element 2. In this embodiment, the design of the breakpoints enhances the flexibility of the scoring element 2. The breakpoints and the serrated structure enhance the bending ability of the scoring element 2 in various directions, improving its ability to pass through tortuous blood vessels.

[0081] Based on the first, second, third and fourth forms, the two ends of the scoring member 2 can be designed as arcs to prevent scratching of blood vessels. The scoring member 2 is made of metal plate such as stainless steel, and the grooves and slots can be cut by laser.

[0082] In the fifth embodiment, the scoring element 2 is a coil spring structure. The scoring element 2 is wound with a flat wire, and after winding, the cross-section of the scoring element 2 is an isosceles triangle (with a vertex angle less than 60 degrees) (the cross-section can also be a polygonal structure). When the scoring element 2 is wound with nickel-titanium flat wire, the pitch can be 0-0.076mm (not shown in the figure). This structure can also improve the compliance of the scoring element 2. The scoring element 2 is made of nickel-titanium alloy, which has excellent shape memory properties.

[0083] In summary, the scored balloon catheter disclosed in the embodiments of the present application has the following beneficial effects:

[0084] 1) A variable diameter guide wire is provided between the inner tube 3 and the outer tube 4 to transmit torque, so that the position of the scoring member 2 can be adjusted by rotating the catheter seat 5;

[0085] 2) The reducing guide wire and the scoring element 2 are located on the same radial section. By observing the position of the reducing guide wire, the position of the scoring element 2 can be known, thereby achieving the purpose of directional cutting;

[0086] 3) The scoring element 2 has various structural designs to make it very flexible and adaptable to tortuous blood vessels.

[0087] As used in this application and the claims, unless the context clearly indicates an exception, the terms "a," "an," "an," and / or "the" are not intended to refer to the singular and may include the plural, unless the context clearly indicates otherwise. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements. The phrase "comprises a..." does not preclude the presence of additional identical elements in the process, method, product, or apparatus that includes the elements.

[0088] In the description of the embodiments of this application, unless otherwise specified, " / " represents or. For example, A / B can represent A or B. "And / or" in this article is simply a description of the association relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, in the description of the embodiments of this application, "plurality" means two or more than two.

[0089] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, and connecting should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0090] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0091] This document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core ideas of this application. It should be noted that for those skilled in the art, without departing from the principles of this application, various improvements and modifications can be made to this application, and such improvements and modifications also fall within the scope of protection of the claims of this application.

Claims

1. A scored balloon catheter, characterized in that: include: A catheter seat (5), an inner tube (3), an outer tube (4) and a balloon body (1), wherein the outer side of the inner tube (3) is sleeved with the outer tube (4), the proximal end of the outer tube (4) is connected to the catheter seat (5), and the distal end is connected to the balloon body (1); The invention also comprises: a notch member (2) and a torsion guide wire (6), wherein the notch member (2) is arranged on the outer wall of the balloon body (1) and is arranged along an axial direction parallel to the balloon body (1), and the torsion guide wire (6) is located on the middle interlayer, 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 on the middle interlayer, outer wall or inner wall of the outer tube (4), and the notch member (2) and the torsion guide wire (6) are located on the same radial section.

2. The scored balloon catheter according to claim 1, characterized in that: The scoring member (2) is multiple; The twist guide wires (6) are multiple and correspond one-to-one with the notched parts (2), or the number of the twist guide wires (6) is one or more, and the twist guide wires (6) correspond one-to-one with some of the notched parts (2).

3. The scored balloon catheter according to claim 1, characterized in that: The distal end of the twisting guide wire (6) is provided with at least one developing ring (7); And / or, 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).

4. The scored balloon catheter according to claim 1, characterized in that: The torsion guide wire (6) is a variable diameter guide wire, the diameter of which gradually decreases from the proximal end to the distal end.

5. The scored balloon catheter according to any one of claims 1 to 4, characterized in that: The notched member (2) is a toothed rack structure with a surface on the side facing away from the balloon body (1).

6. The scored balloon catheter according to claim 5, characterized in that: The cross section of the notched member (2) is L-shaped, and / or a surface of the notched member (2) facing the balloon body (1) is provided with a plurality of slots spaced apart from each other, the slots being used for bonding with the balloon body (1) by means of glue.

7. The scored balloon catheter according to claim 5, characterized in that: The notched piece (2) is provided with a breaking point in the length direction, and the thickness of the notched piece (2) at the breaking point is smaller than the thickness at a location where no breaking point is provided.

8. The scored balloon catheter according to any one of claims 1 to 4, characterized in that: The notching member (2) is a spiral spring structure.

9. The scored balloon catheter according to claim 1, characterized in that: When the torsion guide wire (6) is located on the middle interlayer, the outer wall or the inner wall of the inner tube (3), the torsion guide wire (6) and the inner tube (3) are an integrally formed structure or are bonded; When the torsion guide wire (6) is located on the middle interlayer, the outer wall or the inner wall of the outer tube (4), the torsion guide wire (6) and the outer tube (4) are an integrally formed structure or are bonded; When the torsion guide wire (6) is located between the inner tube (3) and the outer tube (4), the two ends of the torsion guide wire (6) are respectively connected to the balloon body (1) and the catheter seat (5), and part or the whole of the torsion guide wire (6) is connected to the outer side wall of the inner tube (3).

10. The scored balloon catheter according to claim 1, characterized in that: The balloon body (1) is a structure with a middle cylinder and two conical ends, wherein the middle cylinder structure is a working section and the conical structures at both ends are non-working sections; The notched member (2) is arranged on the middle cylindrical structure of the balloon body (1); When there are multiple notching parts (2), the multiple notching parts (2) are evenly arranged in the circumferential direction of the outer surface of the balloon body (1).

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