Drug-loaded scoring balloon and balloon catheter

Abstract

The drug-loaded scoring balloon and balloon catheter of the present application have a drug storage chamber and a drug discharge passage within the sheath. When the sheath is pressed by the lesion location, the scoring member extends from within the sheath, gradually reducing the space in the drug storage chamber and causing it to be pressed, allowing the drug to be released through the drug storage chamber and drug discharge passage onto the surface of the balloon body. Compared to conventional drug-loaded balloons, this design prevents normal vascular tissue from coming into contact with the drug when the drug-loaded scoring balloon is delivered to the lesion location, thereby avoiding drug loss during the balloon delivery process. The drug is only released when the balloon body reaches the lesion location and expands, and the lesion location presses the sheath, allowing the drug to reach the lesion location in a quantitative or sufficient amount. Furthermore, the design of adding a sheath to the scoring member allows the sheath to protect the scoring member during the delivery of the balloon to the lesion location and during the balloon production process, preventing the scoring member from damaging normal tissue.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to a Chinese patent application filed with the China Patent Office on April 26, 2024, bearing application number 202410508940.5 and entitled "Drug-Loaded Scoring Balloon and Balloon Catheter," the entire contents of which are incorporated herein by reference.

[0002] [Technical field] The present application relates to the technical field of medical devices, and in particular to drug-loaded scoring balloons and 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, resulting in various serious complications. The cause of arterial stenosis is mainly the deposition of cholesterol, calcium, and fibrotic tissue, and angioplasty may be the most commonly used treatment method. Angioplasty uses an inflatable balloon to widen the blocked artery, but this treatment method suffers from a high rate of restenosis.

[0004] To solve the above problems, scoring balloons have emerged, where a scoring element on the balloon can diced the stenosis during angioplasty to enhance the effect of stenosis dilation. Some scoring balloons also form a drug coating on the balloon surface, releasing a therapeutic drug at the lesion site, allowing the drug to diffuse into the tissue of the diseased vascular wall, achieving better inhibition of intimal hyperplasia and achieving a better lumen dilation effect during lesion treatment. In the traditional method of using a scoring balloon to form a drug coating on the balloon surface, the drug is constantly lost and carried away by the bloodstream during the process of being delivered to the lesion site along with the balloon, causing the drug to come into contact with normal vascular tissue, resulting in a significant shortage of drug that can reach the lesion site. In addition, the scoring element is likely to damage normal vascular tissue during the process of being delivered to the lesion site.

[0005] Therefore, how to avoid the loss of drug when a drug-loaded scoring balloon is delivered to the lesion location, and how to prevent the scoring element from damaging normal vascular tissue when it is delivered to the lesion location are problems that those skilled in the art must solve as soon as possible. Summary of the Invention [Problem to be solved by the invention]

[0006] The object of the present application is to provide a drug-loaded scoring balloon and balloon catheter that can effectively avoid drug loss during the process of delivering the drug-loaded scoring balloon to the lesion location, and that can prevent damage to normal vascular tissue during the process of delivering the scoring element to the lesion location. [Means for solving the problem]

[0007] In order to solve the above technical problems, the present application provides: The balloon body, A scoring member is provided on the outer wall of the balloon body and is arranged along an axial direction parallel to the balloon body; a sheath, the bottom end of which is connected to the balloon body and the tip of which covers the scoring member, the tip of which has a first fold line at a position opposite to the scoring member, the first fold line being used to break when the sheath is pressed, the sheath having a drug storage chamber for storing a drug and a drug discharge passage for discharging the drug to the outside, both ends of which are in communication with the outside and the drug storage chamber, A drug-loaded scoring balloon is provided in which, when the balloon body reaches the lesion location and expands, and the tip of the sheath is pressed by the inner wall of the blood vessel, as the space in the drug storage chamber gradually becomes smaller, the drug is discharged onto the surface of the balloon body through the drug storage chamber and the drug discharge passage, and the first fold line at the tip of the sheath breaks, causing the tip of the scoring member to extend from within the sheath.

[0008] Optionally, in the drug-loaded scoring balloon, a protective membrane is provided at the end opening of the drug discharge passage that communicates with the outside, and a second fold line is provided on the protective membrane, which is used to break when the sheath is pressed.

[0009] Optionally, in the drug-loaded scoring balloon, an attachment chamber is provided inside the sheath, a slide sheet is provided at the bottom of the attachment chamber, and a slide groove member that slides into the slide sheet is provided at the bottom of the scoring member; In the initial state, the scoring member is located at the top of the mounting chamber, and the drug storage chamber is formed between the sliding groove member of the scoring member and the sliding sheet and / or between the sliding sheet and the side wall of the mounting chamber. When the balloon body reaches the lesion location and expands, and the tip of the sheath is pressed by the inner wall of the blood vessel, the scoring member moves to the sliding sheet, and the space of the drug storage chamber gradually becomes smaller.

[0010] Optionally, in the above-mentioned drug-loaded scoring balloon, the cross section of the slide sheet is T-shaped, the slide groove member includes two parallel flat plates and a limiting plate provided on the bottom side of the flat plates, the top of the flat plates is connected to the scoring member, and the limiting plate is used to abut against the tip of the slide sheet to achieve restriction.

[0011] Optionally, the drug-loaded scoring balloon further includes a guide tube, which is provided on the side of the sheath and laid on the outer wall of the balloon body, one end of which is connected to the drug discharge passage and has multiple through holes drilled in the side wall.

[0012] Optionally, in the drug-loaded scoring balloon, an attachment chamber is provided inside the sheath, the scoring member is provided at the bottom of the attachment chamber, and the drug storage chamber is formed between the scoring member and the attachment chamber of the sheath.

[0013] Optionally, in the drug-loaded scoring balloon, an attachment chamber is provided inside the sheath, the attachment chamber covers the scoring member, and the drug storage chamber is provided on the side of the scoring member.

[0014] Optionally, in the above-mentioned drug-loaded scoring balloon, the drug discharge passage includes a buffer chamber and a drug discharge through-hole, and both ends of the buffer chamber are connected to the drug storage chamber and the drug discharge through-hole, respectively. When the balloon body reaches the lesion location and expands, and the tip of the sheath is pressed by the inner wall of the blood vessel, as the space in the drug storage chamber gradually becomes smaller, the drug is sequentially discharged onto the surface of the balloon body through the drug storage chamber, the buffer chamber, and the drug discharge through-hole.

[0015] Optionally, in the drug-loaded scoring balloon, the drug discharge passages are arranged in multiple locations along the longitudinal direction of the sheath, and / or the drug discharge passages are distributed on both sides of the sheath, and / or the number of buffer chambers in each drug discharge passage is multiple and the multiple buffer chambers are connected to each other, and / or the drug discharge through holes in each drug discharge passage are arranged in multiple locations along the height direction of the sheath.

[0016] The present application further provides a balloon catheter including the drug-loaded scoring balloon described above.

[0017] The present application provides a drug-loaded scoring balloon, the beneficial effects of which are as follows:

[0018] By forming a drug storage chamber and a drug discharge passage within the sheath, when the sheath is pressed by the lesion location, the scoring member extends from within the sheath, the space of the drug storage chamber gradually decreases, and pressure is applied, causing the drug to be released through the drug storage chamber and drug discharge passage onto the surface of the balloon body. Compared to conventional drug balloons, this design prevents normal vascular tissue from coming into contact with the drug during the process of delivering the drug-loaded scoring balloon to the lesion location, thereby avoiding drug loss during the delivery process of the drug-loaded scoring balloon. The drug can only be released when the lesion location presses the sheath after the drug-loaded scoring balloon reaches the lesion location and the balloon body expands, allowing the drug to reach the lesion location in a quantitative or sufficient amount. Furthermore, the design of adding a sheath to the scoring member allows the sheath to protect the scoring member during the process of delivering the drug-loaded scoring balloon to the lesion location and during the process of producing the drug-loaded scoring balloon, preventing the scoring member from damaging normal tissue.

[0019] The present application further provides a balloon catheter having the above-mentioned drug-loaded scoring balloon, which has similar beneficial effects and will not be further described herein.

[0020] In order to more clearly describe the technical solutions in the embodiments of the present application or the prior art, the following briefly describes the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings described below are only the embodiments of the present application, and those skilled in the art can obtain other drawings based on the provided drawings without any creative efforts. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a structural schematic diagram of a drug-loaded scoring balloon according to Example 1 of the present application. [Figure 2] FIG. 1 is a front view of a drug-loaded scoring balloon according to Example 1 of the present application. [Figure 3] FIG. 2 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 1 of the present application before deformation. [Figure 4] FIG. 4 is a partial enlarged view of part A in FIG. 3. [Figure 5] FIG. 2 is a cross-sectional schematic diagram of the drug-loaded scoring balloon according to Example 1 of the present application after deformation. [Figure 6] FIG. 6 is a partial enlarged view of part B in FIG. 5. [Figure 7] 1 is a cross-sectional schematic view of a sheath according to Example 1 of the present application. [Figure 8] FIG. 1 is a front view of a scoring member according to Example 1 of the present application. [Figure 9] FIG. 9 is a cross-sectional view taken along the line A-A in FIG. [Figure 10] FIG. 1 is a structural schematic diagram of a drug-loaded scoring balloon according to Example 2 of the present application. [Figure 11] FIG. 1 is a front view of a drug-loaded scoring balloon according to Example 2 of the present application. [Figure 12] FIG. 2 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 2 of the present application before deformation. [Figure 13] FIG. 13 is a partial enlarged view of part C in FIG. [Figure 14] FIG. 10 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 2 of the present application after deformation. [Figure 15] FIG. 15 is a partially enlarged view of part D in FIG. [Figure 16] FIG. 1 is a structural schematic diagram of a drug-loaded scoring balloon according to Example 3 of the present application. [Figure 17] FIG. 1 is a front view of a drug-loaded scoring balloon according to Example 3 of the present application. [Figure 18] FIG. 1 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 3 of the present application before deformation. [Figure 19] FIG. 19 is a partially enlarged view of part E in FIG. [Figure 20] FIG. 10 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 3 of the present application after deformation. [Figure 21] FIG. 21 is a partially enlarged view of part F in FIG. 20. [Figure 22] FIG. 1 is a structural schematic diagram of a drug-loaded scoring balloon according to Example 4 of the present application. [Figure 23] FIG. 1 is a front view of a drug-loaded scoring balloon according to Example 4 of the present application. [Figure 24] FIG. 1 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 4 of the present application before deformation. [Figure 25] FIG. 25 is a partially enlarged view of part G in FIG. 24. [Figure 26] FIG. 10 is a cross-sectional schematic diagram of a drug-loaded scoring balloon according to Example 4 of the present application after deformation. [Figure 27] FIG. 27 is a partial enlarged view of part H in FIG. 26. 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, and 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 intended to help interpret the present application, and do not limit the present application.

[0023] In the description of this application, the terms "proximal end" and "distal end" as used throughout the specification refer to proximal and distal ends relative to the operator, and 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 description only and do not limit the 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 purpose of the present application is to provide a drug-loaded scoring balloon and balloon catheter that can effectively avoid drug loss during the process of transporting the drug-loaded scoring balloon to the lesion location, and that can prevent damage to normal vascular tissue during the process of transporting the scoring element to the lesion location.

[0025] In order to make those skilled in the art better understand the technical solutions provided by the present application, the present application will be described in more detail below with reference to the drawings and specific embodiments.

[0026] Specifically, with reference to FIGS. 1 to 27, the drug-loaded scoring balloon disclosed in the examples of the present application includes a balloon body 1, a scoring member 2, and a sheath 3.

[0027] Here, the scoring member 2 is provided on the outer wall of the balloon body 1 and is arranged along an axial direction parallel to the balloon body 1. Note that providing the scoring member 2 on the outer wall of the balloon body 1 does not simply mean that the scoring member 2 is fixed to the outer wall of the balloon body 1, but rather refers to the spatial positional relationship between the two, not a fixed relationship. In other words, providing the scoring member 2 on the outer wall of the balloon body 1 should be understood to mean that the scoring member 2 is located outside the balloon body 1. Specifically, the scoring member 2 may be directly fixed to the outer wall of the balloon body 1, or it may be indirectly installed on the outer wall of the balloon body 1 via another member. For example, installing the scoring member 2 on the sheath 3 and then installing the sheath 3 on the outer wall of the balloon body 1 can similarly achieve the effect of installing the scoring member 2 on the outer wall of the balloon body 1.

[0028] The balloon body 1 may have a cylindrical middle and conical ends, with the cylindrical middle being the working segment and the conical ends being the non-working segments. A developing ring is provided on the outer surface of the inner tube corresponding to the balloon body 1, which can position the balloon body 1 at the lesion location.

[0029] The scoring member 2 is provided in the middle cylindrical portion of the balloon body 1 and may be arranged along an axial direction parallel to the balloon body 1, and can be fixed by adhering it with an adhesive. Note that in a solution in which the scoring member 2 is slidable, it is not necessary to fix the scoring member 2 with an adhesive.

[0030] The number of scoring members 2 is n, where n is an integer greater than or equal to 1. If the number is plural, the scoring members 2 can be evenly spaced around the circumference of the outer surface of the balloon body 1, and the pitch angle between any two adjacent scoring members 2 in the circumferential direction is 360° / n. Optionally, if the number of scoring members 2 is three, the pitch angle between two adjacent scoring members 2 in the circumferential direction is 120°.

[0031] When there are multiple scoring members 2, there are also multiple sheaths 3, each corresponding to one of the scoring members 2. The bottom end of the sheath 3 is connected to the balloon body 1, and the tip end covers the scoring member 2; that is, in the initial state, the scoring member 2 is covered by the sheath 3, and the entire scoring member 2, particularly the blade portion of the scoring member 2, is not exposed.

[0032] A first fold line is provided at the tip of the sheath 3 at a position facing the scoring member 2, and the first fold line is used to break the sheath when it is compressed. Typically, the blade of the scoring member 2 is located on the side of the scoring member 2 facing away from the balloon body 1, and to ensure that the sheath 3 breaks when it is compressed, the first fold line can be positioned at a position corresponding to the blade of the scoring member 2. When the sheath 3 is compressed, the blade of the scoring member 2 achieves a cutting action on the first fold line and can assist in cutting the first fold line.

[0033] The sheath 3 is provided with a drug storage chamber 301 for storing a drug and a drug discharge passage for releasing the drug to the outside, and both ends of the drug discharge passage are connected to the outside and the drug storage chamber 301, respectively, so that when the space in the drug storage chamber 301 becomes small or the pressure increases, the drug stored in the drug storage chamber 301 can be discharged to the outside through the drug discharge passage. Furthermore, the drug can be injected from the end of the sheath 3, and after injection, the sheath 3 is sealed so that the drug is sealed in the drug storage chamber 301 and can only be pushed out through the drug discharge passages on both sides of the sheath 3.

[0034] When the balloon body 1 reaches the lesion location and expands, the tip of the sheath 3 is pressed by the inner wall of the blood vessel, moving the tip of the sheath 3 toward the balloon body 1, and then gradually reducing the space of the drug storage chamber 301.As the space of the drug storage chamber 301 gradually reduces, the drug stored in the drug storage chamber 301 is discharged onto the surface of the balloon body 1 through the drug discharge passage, and the first fold line at the tip of the sheath 3 breaks, causing the tip of the scoring member 2 (at least the blade portion of the scoring member 2) to extend from within the sheath 3.

[0035] The purpose of providing the first fold line on the sheath 3 is to allow the sheath 3 to cover the entire scoring member 2 when the balloon body 1 has not yet reached the predetermined position, preventing the scoring member 2 from coming into contact with vascular tissue and thus preventing the scoring member 2 from injuring the human body and facilitating storage and transportation; and to allow the first fold line to break when the balloon body 1 reaches the lesion location and expands, causing the tip of the sheath 3 to be pressed against the inner wall of the blood vessel, thereby exposing the scoring member 2 from within the sheath 3. The first fold line is specifically provided along an axial direction parallel to the balloon body 1; that is, after the sheath 3 breaks along the first fold line, it is split in half, thereby exposing the scoring member 2 inside.

[0036] The drug-loaded scoring balloon disclosed in the examples of the present application has a drug storage chamber 301 and a drug discharge passage formed within the sheath 3. When the sheath 3 is pressed by the lesion location, the scoring member 2 extends from within the sheath 3, reducing the space of the drug storage chamber 301 and causing it to be pressed. As a result, the drug is released onto the surface of the balloon body 1 through the drug storage chamber 301 and the drug discharge passage. Compared to conventional drug-loaded balloons, this design prevents normal vascular tissue from coming into contact with the drug during the process of the drug-loaded scoring balloon being delivered to the lesion location. This avoids the loss of drug during the delivery process of the lune, and the drug can be released only when the drug-loaded scoring balloon reaches the lesion location and the lesion location presses against the sheath 3 after the balloon body 1 is expanded, allowing the drug to reach the lesion location in a quantitative or sufficient amount.In addition, by designing the sheath 3 to be added to the scoring member 2, the sheath 3 can protect the scoring member 2 during the delivery of the drug-loaded scoring balloon to the lesion location and the production process of the drug-loaded scoring balloon, preventing the scoring member 2 from damaging normal tissue.

[0037] The drug discharge passage may be a small-diameter hole, provided that the diameter of the hole on the outlet side of the drug discharge passage satisfies the requirement for sealing using surface tension. When the drug is liquid, surface tension is naturally formed on the surface on the outlet side of the drug discharge passage, and when sheath 3 is not pressed, the surface tension prevents the drug from flowing out of the drug discharge passage.

[0038] If the drug discharge passage is a large-diameter hole, the surface tension formed is not sufficient to seal the drug in the drug storage chamber 301 without leaking. Based on this, in a specific embodiment, a protective film is provided at the end of the drug discharge passage that communicates with the outside, thereby ensuring that the drug will not flow out of the drug discharge passage even under natural conditions; only when the sheath 3 is pressed can the drug flow out of the drug discharge passage.

[0039] To ensure that the drug can flow out of the drug discharge passage when the sheath 3 is compressed, a second fold line is provided on the protective membrane, and when the sheath 3 is compressed, the space in the drug storage chamber 301 becomes smaller, causing the drug to press against the protective membrane and break the second fold line. The operating principle of the second fold line is similar to that of the first fold line, and there may be multiple second fold lines.

[0040] There are several types of arrangement for the scoring member 2 within the sheath 3. In one specific embodiment, an attachment chamber is provided inside the sheath 3, a slide sheet 304 is provided at the bottom of the attachment chamber (as shown in FIG. 7 , at the bottom of the attachment chamber, i.e., the side of the attachment chamber closer to the balloon body 1), and a slide groove member 201 is provided at the bottom of the scoring member 2 along the radial direction of the balloon body 1, which slides into engagement with the slide sheet 304.

[0041] In the initial state, the scoring member 2 is located at the top of the mounting chamber, and specifically, the scoring member 2 can be restricted to the top of the mounting chamber by the restraint of the sheath 3. A drug storage chamber 301 for storing a drug is formed between the sliding groove member 201 of the scoring member 2 and the sliding sheet 304 and / or between the sliding sheet 304 and the side wall of the mounting chamber, and since the scoring member 2 is located at the top of the mounting chamber and there is a large space between the sliding groove member 201 and the sliding sheet 304, a drug can be accommodated, and there is also a certain amount of space between the sliding sheet 304 and the side wall of the mounting chamber in which a drug can be stored.

[0042] When the balloon body 1 reaches the lesion location and expands, and the tip of the sheath 3 is pressed against the inner wall of the blood vessel, the scoring member 2 moves toward the sliding sheet 304 under the guidance of the sliding groove member 201 (because the sliding sheet 304 is located on the side of the mounting chamber closer to the balloon body 1, the scoring member 2 moves toward the side of the mounting chamber closer to the balloon body 1 under the guidance of the sliding groove member 201), gradually reducing the space in the drug storage chamber 301. That is, the scoring member 2 moves toward the balloon body 1 due to the sliding fit between the sliding groove member 201 and the sliding sheet 304, gradually reducing the space between the sliding groove member 201 and the sliding sheet 304, and the sliding groove member 201 gradually occupies the space between the sliding sheet 304 and the side wall of the mounting chamber, gradually reducing the volume of this space, and therefore the space in the drug storage chamber 301 gradually reduces as the scoring member 2 moves.

[0043] As shown in Figures 7 to 9, the cross section of the slide sheet 304 is T-shaped, and the slide groove member 201 includes two parallel flat plates and a limiting plate provided on the bottom side of the flat plates (i.e., the side facing the balloon body 1), the top of the flat plates is connected to the scoring member 2, and the limiting plate is used to abut against the bottom tip of the slide sheet 304, thereby limiting the vertical movement of the scoring member 2 and preventing the scoring member 2 from falling off.

[0044] As shown in Figures 18 to 21, in another specific embodiment, an attachment chamber is provided inside the sheath 3, a scoring member 2 is provided at the bottom of the attachment chamber, and a drug storage chamber 301 is formed between the scoring member 2 and the attachment chamber of the sheath 3.

[0045] As shown in Figures 24 to 27, in another specific embodiment, an attachment chamber is provided inside the sheath 3, the attachment chamber covers the scoring member 2, and the drug storage chamber 301 is provided on the side of the scoring member 2.

[0046] As shown in Figures 12 to 15, this solution can further include a guide tube 303, which is attached to the side of the sheath 3 and installed on the outer wall of the balloon body 1. One end of the guide tube 303 is connected to the drug discharge passage, and the side wall has multiple through-holes. There are multiple guide tubes 303, each corresponding to a drug discharge passage. The two side walls of the guide tube 303 have multiple through-holes. When the balloon body 1 is inflated and the top of the sheath 3 is pressed against the inner wall of the blood vessel, the space in the drug storage chamber 301 is reduced, and the drug is discharged onto the surface of the balloon body 1 through the drug storage chamber 301, the drug discharge passage, and the guide tube 303.

[0047] To prevent the drug inside from being expelled due to light pressure on the sheath 3, the drug discharge passage includes a buffer chamber 302 and a drug discharge through-hole. Both ends of the buffer chamber 302 are connected to the drug storage chamber 301 and the drug discharge through-hole, respectively. Specifically, the buffer chamber 302 and the drug storage chamber 301 may be connected via several small holes. When the balloon body 1 reaches the lesion and expands, and the tip of the sheath 3 is pressed against the inner wall of the blood vessel, the space in the drug storage chamber 301 gradually decreases, and the drug is sequentially discharged to the surface of the balloon body 1 through the drug storage chamber 301, the buffer chamber 302, and the drug discharge through-hole. Initially, there is no drug in either the buffer chamber 302 or the drug discharge through-hole, and the buffer chamber 302 is part of the drug discharge passage. The protective film and second bend line are provided at the end opening of the drug discharge through-hole, which communicates with the outside.

[0048] Furthermore, the number and arrangement of the drug discharge passages and the buffer chambers and drug discharge through-holes therein can be variously combined and designed. For example, multiple drug discharge passages can be arranged along the length of the sheath 3, the drug discharge passages can be distributed on both sides of the sheath 3, each drug discharge passage can have multiple buffer chambers 302, the multiple buffer chambers 302 can be connected to each other, and each drug discharge passage can have multiple drug discharge through-holes arranged along the height of the sheath 3.

[0049] A plurality of drug discharge holes are drilled in the side of the sheath 3 from top to bottom, and the drug discharge holes are connected to the buffer chamber 302. The drug discharge holes located at different heights spray the drug over different distances. By providing drug discharge holes at different heights, the drug can cover as much of the surface of the balloon body 1 as possible.

[0050] For example, the balloon body 1 may have a diameter of 1.0 mm to 40.0 mm and a length of 10 mm to 300 mm, and may be made of one or more of the following materials: polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or a highly biocompatible polymer material. Those skilled in the art can determine the size and material of the balloon body 1 according to their needs, and are not limited to the size ranges and materials disclosed in the above examples.

[0051] The material of the scoring member 2 may be medical stainless steel, cobalt chromium alloy, nitinol alloy or other highly biocompatible metals or alloys, or may be a highly biocompatible polymer material; in order to further improve the flexibility of the scoring balloon, the material of the scoring member 2 can be selected from nickel titanium alloy, which has good shape memory properties.

[0052] The present application also discloses a balloon catheter, comprising a catheter base, an inner tube, an outer tube, the drug-loaded scoring balloon of the specific embodiment, and a distal tube. The catheter base is hollow and is provided with a balloon pressure filling / releasing connection port and a guidewire outlet. The inner tube is fitted into the outer tube, and the cavity of the inner tube is a guidewire chamber, which communicates with the guidewire outlet. During use, a guidewire enters the distal tube and is withdrawn from the body through the guidewire outlet.

[0053] The proximal end of the outer tube is connected to the catheter base, and the distal end of the outer tube is provided with a balloon body 1. A balloon filling chamber is formed between the inner wall of the outer tube and the outer wall of the inner tube. The balloon pressure filling and releasing connection port communicates with the balloon through the balloon filling chamber and is used to fill, expand or release the balloon.

[0054] Apparently, the balloon catheter including the drug-loaded scoring balloon described above has similar beneficial effects, and the description thereof will be omitted here.

[0055] In the prior art, in the method of forming a drug coating on the surface of a scoring balloon, there is a large loss of the drug as the balloon reaches the lesion, and the drug is easily carried away by the bloodstream, which is unfavorable for absorption at the location required by the blood vessel. In the drug-loaded scoring balloon and balloon catheter of the present solution, a drug storage chamber 301 is formed in the scoring member 2 or sheath 3, and a drug discharge passage is formed in the sheath 3. When the sheath 3 is pressed by the lesion, the scoring member 2 extends from the sheath 3, reducing the drug storage space and causing pressure, so the drug is released onto the surface of the balloon body 1 through the drug discharge passage. This is advantageous compared to conventional drug-loaded balloons. With this design, normal vascular tissue does not come into contact with the drug when the balloon body 1 is delivered to the lesion location, thereby avoiding drug loss during the balloon delivery process. The drug can only be released when the balloon body 1 reaches the lesion location and, after expansion, the lesion location presses against the sheath 3, allowing the drug to reach the lesion location in a quantitative or sufficient amount. Furthermore, the design of the sheath 3 in the scoring member 2 allows the sheath 3 to protect the scoring member 2 during the delivery of the drug-loaded scoring balloon to the lesion location and during the production of the drug-loaded scoring balloon, preventing the scoring member 2 from damaging normal tissue.

[0056] In the description of this application, "plural" means two or more, and as stated, "first" and "second" merely distinguish technical features, and cannot be understood as indicating or implying relative importance, or as implicitly clarifying the number of indicated technical features, or as a priority relationship for implicitly clarifying the indicated technical features.

[0057] As used herein and in the claims, unless the context clearly indicates otherwise, words such as "a," "one," "an," "one kind," and / or "the" are not intended to refer to the singular and may include the plural. Generally, the terms "comprise" and "comprising" refer only to the inclusion of specifically identified steps and elements; these steps and elements do not constitute an exclusive list; a method or apparatus may include other steps or elements. An element qualified by "comprising one ..." does not exclude the presence of other identical elements in the process, method, product, or apparatus that includes the element.

[0058] In the description of the examples of the present application, unless otherwise specified, " / " means "or," for example, A / B can mean A or B. In this specification, "and / or" is merely used to explain 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. In addition, in the description of the examples of the present application, "plurality" means two or more.

[0059] 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.

[0060] 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.

[0061] 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]

[0062] 1-balloon body, 2—scoring member; 201—slide groove member; 3 - sheath, 301 - drug storage chamber, 302 - buffer chamber, 303 - guide tube, 304 - slide sheet

Claims

1. A drug-loaded scoring balloon, A balloon body (1), A scoring member (2) is provided on the outer wall of the balloon body (1) and is arranged along an axial direction parallel to the balloon body (1); a sheath (3), the bottom end of which is connected to the balloon body (1) and the tip of which covers the scoring member (2); a first fold line is provided at the tip of the sheath (3) at a position facing the scoring member (2), the first fold line being used to break when the sheath (3) is pressed; a drug storage chamber (301) for storing a drug inside the sheath (3) and a drug discharge passage for discharging the drug to the outside, both ends of which respectively communicate with the outside and the drug storage chamber (301); A drug-loaded scoring balloon characterized in that, when the balloon body (1) reaches the lesion location and expands, and the tip of the sheath (3) is pressed by the inner wall of the blood vessel, as the space of the drug storage chamber (301) gradually becomes smaller, the drug is discharged onto the surface of the balloon body (1) through the drug storage chamber (301) and the drug discharge passage, and the first fold line at the tip of the sheath (3) breaks, allowing the tip of the scoring member (2) to extend from within the sheath (3).

2. The drug-loaded scoring balloon of claim 1, characterized in that a protective film is provided at the end opening of the drug discharge passage that communicates with the outside, and a second fold line is provided on the protective film, and the second fold line is used to break when the sheath (3) is pressed.

3. An attachment chamber is provided inside the sheath (3), a slide sheet (304) is provided at the bottom of the attachment chamber, and a slide groove member (201) that slides into the slide sheet (304) is provided at the bottom of the scoring member (2), 2. A drug-loaded scoring balloon as described in claim 1, characterized in that, in an initial state, the scoring member (2) is located at the top of the mounting chamber, and the drug storage chamber (301) is formed between the sliding groove member (201) of the scoring member (2) and the sliding sheet (304) and / or between the sliding sheet (304) and the side wall of the mounting chamber, and when the balloon body (1) reaches the lesion location and expands, and the tip of the sheath (3) is pressed by the inner wall of the blood vessel, the scoring member (2) moves toward the sliding sheet (304), and the space of the drug storage chamber (301) gradually becomes smaller.

4. The drug-loaded scoring balloon of claim 3, characterized in that the cross section of the slide sheet (304) is T-shaped, the slide groove member (201) includes two parallel flat plates and a limiting plate provided on the bottom side of the flat plates, the top of the flat plates is connected to the scoring member (2), and the limiting plate is used to abut against the tip of the slide sheet (304) to achieve restriction.

5. The drug-loaded scoring balloon of claim 3, further comprising a guide tube (303), the guide tube (303) being provided on the side of the sheath (3) and laid on the outer wall of the balloon body (1), the guide tube (303) having one end connected to the drug discharge passage and having a plurality of through holes drilled in the side wall.

6. The drug-loaded scoring balloon of claim 1, characterized in that an attachment chamber is provided inside the sheath (3), the scoring member (2) is provided at the bottom of the attachment chamber, and the drug storage chamber (301) is formed between the scoring member (2) and the attachment chamber of the sheath (3).

7. The drug-loaded scoring balloon of claim 1, characterized in that an attachment chamber is provided inside the sheath (3), the attachment chamber covers the scoring member (2), and the drug storage chamber (301) is provided on the side of the scoring member (2).

8. The drug-loaded scoring balloon of claim 1, characterized in that the drug discharge passage includes a buffer chamber (302) and a drug discharge through-hole, both ends of the buffer chamber (302) are connected to the drug storage chamber (301) and the drug discharge through-hole, respectively, and when the balloon body (1) reaches the lesion location and expands, and the tip of the sheath (3) is pressed by the inner wall of the blood vessel, as the space of the drug storage chamber (301) gradually becomes smaller, the drug is sequentially discharged onto the surface of the balloon body (1) through the drug storage chamber (301), the buffer chamber (302) and the drug discharge through-hole.

9. The drug-loaded scoring balloon of claim 8, characterized in that the drug discharge passages are arranged in multiple locations along the longitudinal direction of the sheath (3), and / or the drug discharge passages are distributed on both sides of the sheath (3), and / or the number of buffer chambers (302) in each drug discharge passage is multiple and the multiple buffer chambers (302) are connected to each other, and / or the drug discharge through holes in each drug discharge passage are arranged in multiple locations along the height direction of the sheath (3).

10. A balloon catheter comprising the drug-loaded scoring balloon according to any one of claims 1 to 9.

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