Drug-carrying 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 National Intellectual Property Administration on April 26, 2024, with application number 202410508940.5 and invention title "Drug - loaded Scoring Balloon and Balloon Catheter", the entire content of which is incorporated herein by reference.

[0002] [Technical Field] This application belongs to the technical field of medical devices, and particularly relates to a drug - loaded scoring balloon and a balloon catheter.

Background Art

[0003] Over the years, arterial occlusion in the human body has been a major medical problem. This is because the blood flow passing through the artery decreases due to arterial occlusion, resulting in various severe complications. The main causes of arterial stenosis are 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 dilate the occluded artery, but such a treatment method has the problem of a high restenosis rate.

[0004] To solve the above problems, scoring balloons have emerged. The scoring member in the balloon can dice the stenosis during angioplasty to reinforce the effect of stenosis dilation. Some scoring balloons also form a drug coating on the balloon surface, release therapeutic drugs at the lesion site, and the drugs diffuse into the tissue of the lesion vascular wall to achieve a better effect of suppressing intimal hyperplasia, and achieve a better lumen dilation effect during the treatment of the lesion. In the conventional method where the scoring balloon forms a drug coating on the balloon surface, during the process of transporting the drug to the lesion site together with the balloon, the drug is constantly lost and carried away by the blood flow, causing normal vascular tissue to contact the drug, but the drug reaching the lesion site is severely insufficient. Also, the scoring member is likely to damage normal vascular tissue during the process of being transported to the lesion site.

[0005] Therefore, how to avoid drug loss during the process of transporting the drug-carrying scoring balloon to the lesion site, as well as how to prevent damage to normal vascular tissue during the process of transporting the scoring member to the lesion site, are problems that those skilled in the art should urgently solve. [Overview of the project] [Problems that the invention aims to solve]

[0006] The object of this application is to provide a drug-carrying scoring balloon and a balloon catheter that can effectively avoid drug loss during the process of transporting the drug-carrying scoring balloon to the lesion site, and that can prevent damage to normal vascular tissue during the process of transporting the scoring member to the lesion site. [Means for solving the problem]

[0007] To solve the above technical problems, this application proposes: The balloon body and 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, wherein the bottom end of the sheath is connected to the balloon body, the tip covers the scoring member, a first fold is provided at the tip of the sheath facing the scoring member, the first fold is used to break when the sheath is pressed, a drug storage chamber for storing a drug and a drug discharge passage for releasing a drug to the outside are provided inside the sheath, and both ends of the drug discharge passage each include a sheath communicating with the outside and the drug storage chamber, The present invention provides a drug-carrying scoring balloon in which, when the balloon body reaches the lesion site and inflates, and the tip of the sheath is pressed against the inner wall of the blood vessel, the space in the drug storage chamber gradually decreases, causing the drug to be discharged through the drug storage chamber and the drug discharge passage to the surface of the balloon body, and the first fold line at the tip of the sheath breaks, causing the tip of the scoring member to extend out of the sheath.

[0008] In the drug-carrying scoring balloon described above, a protective membrane is provided at the end of the drug discharge passage that communicates with the outside, and a second fold is provided in the protective membrane, the second fold being used to break when the sheath is pressed.

[0009] In the drug-carrying scoring balloon described above, 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 is provided at the bottom of the scoring member to slide into the slide sheet. 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 slide groove member of the scoring member and the slide sheet and / or between the slide sheet and the side wall of the mounting chamber. When the balloon body reaches the lesion site and inflates, and the tip of the sheath is pressed against the inner wall of the blood vessel, the scoring member moves to the slide sheet, and the space of the drug storage chamber gradually decreases.

[0010] In the drug-carrying scoring balloon described above, 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 surface of the flat plates, the tops of the flat plates are connected to the scoring member, and the limiting plate is used to contact the front end of the slide sheet to achieve restriction.

[0011] Optionally, the drug-carrying 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, with one end of the guide tube communicating with the drug discharge passage and having a plurality of through holes in its side wall.

[0012] In the drug-carrying scoring balloon described above, 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] In the drug-carrying scoring balloon described above, 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] In the drug-carrying scoring balloon described above, the drug discharge passage includes a buffer chamber and a drug discharge through-hole, with both ends of the buffer chamber communicating with the drug storage chamber and the drug discharge through-hole, respectively, and when the balloon body reaches the lesion site and inflates, and the tip of the sheath is pressed against the inner wall of the blood vessel, the drug is discharged sequentially through the drug storage chamber, the buffer chamber and the drug discharge through-hole to the surface of the balloon body as the space in the drug storage chamber gradually decreases.

[0015] Selectively, in the drug-carrying 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, the buffer chambers are in communication with 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] This application further provides a balloon catheter including the drug-carrying scoring balloon described above.

[0017] This invention provides a drug-carrying 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 site, the scoring member extends from within the sheath, the space in the drug storage chamber gradually shrinks and is pressed, and the drug is released through the drug storage chamber and drug discharge passage to the surface of the balloon body. Compared to conventional drug balloons, with this design, normal vascular tissue does not come into contact with the drug during the process of transporting the drug-carrying scoring balloon to the lesion site, thereby avoiding drug loss during the transport process of the drug-carrying scoring balloon. Drug can be released only when the lesion site presses against the sheath after the drug-carrying scoring balloon has reached the lesion site and the balloon body has expanded, so that the drug can reach the lesion site in a quantitative or sufficient amount. Furthermore, by designing the scoring member with an additional sheath, the sheath protects the scoring member during the process of transporting the drug-carrying scoring balloon to the lesion site and during the production process of the drug-carrying scoring balloon, preventing the scoring member from damaging normal tissue.

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

[0020] To more clearly illustrate the embodiments of this application or the technical solutions in the prior art, the drawings necessary for use in the descriptions of the embodiments or the prior art will be briefly described below. However, obviously, the drawings described below are merely embodiments of this application, and those skilled in the art can obtain other drawings based on the provided drawings without any creative effort. [Brief explanation of the drawing]

[0021] [Figure 1] It is a structural schematic diagram of the drug-carrying scoring balloon according to Example 1 of the present application. [Figure 2] It is a front view of the drug-carrying scoring balloon according to Example 1 of the present application. [Figure 3] It is a cross-sectional schematic diagram before deformation of the drug-carrying scoring balloon according to Example 1 of the present application. [Figure 4] It is a partial enlarged view of part A in FIG. 3. [Figure 5] It is a cross-sectional schematic diagram after deformation of the drug-carrying scoring balloon according to Example 1 of the present application. [Figure 6] It is a partial enlarged view of part B in FIG. 5. [Figure 7] It is a cross-sectional schematic diagram of the sheath according to Example 1 of the present application. [Figure 8] It is a front view of the scoring member according to Example 1 of the present application. [Figure 9] It is a cross-sectional schematic diagram in the A - A direction of FIG. 8. [Figure 10] It is a structural schematic diagram of the drug-carrying scoring balloon according to Example 2 of the present application. [Figure 11] It is a front view of the drug-carrying scoring balloon according to Example 2 of the present application. [Figure 12] It is a cross-sectional schematic diagram before deformation of the drug-carrying scoring balloon according to Example 2 of the present application. [Figure 13] It is a partial enlarged view of part C in FIG. 12. [Figure 14] It is a cross-sectional schematic diagram after deformation of the drug-carrying scoring balloon according to Example 2 of the present application. [Figure 15] It is a partial enlarged view of part D in FIG. 14. [Figure 16] It is a structural schematic diagram of the drug-carrying scoring balloon according to Example 3 of the present application. [Figure 17] It is a front view of the drug-carrying scoring balloon according to Example 3 of the present application. [Figure 18] It is a cross-sectional schematic diagram before deformation of the drug-carrying scoring balloon according to Example 3 of the present application. [Figure 19] This is a magnified view of section E in Figure 18. [Figure 20] This is a schematic cross-sectional view of the drug-carrying scoring balloon after deformation, according to Example 3 of the present application. [Figure 21] This is a magnified view of section F in Figure 20. [Figure 22] This is a schematic diagram of the structure of a drug-carrying scoring balloon according to Example 4 of the present application. [Figure 23] This is a front view of the drug-carrying scoring balloon according to Embodiment 4 of the present application. [Figure 24] This is a schematic cross-sectional view of the drug-carrying scoring balloon before deformation, according to Embodiment 4 of the present application. [Figure 25] This is a magnified view of section G in Figure 24. [Figure 26] This is a schematic cross-sectional view of the drug-carrying scoring balloon after deformation, according to Embodiment 4 of the present application. [Figure 27] This is a magnified view of section H in Figure 26. [Modes for carrying out the invention]

[0022] The embodiments of this application will be described in detail below, and these embodiments are illustrated in the drawings. Throughout the entire specification, the same or similar reference numerals indicate the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the drawings are illustrative and are for illustrative purposes only, and are not intended to limit this application.

[0023] In this description, the terms “proximal end” and “distal end” as used throughout the specification mean the proximal and distal ends relative to the operator. When using this application, the end closer to the physician or operator is the “proximal end,” i.e., the end where the operator is located, and the end further away from the physician or operator is the “distal end,” i.e., the end where the balloon is located. The above-mentioned descriptions of orientations are for the convenience and simplification of this description and do not indicate or imply that such devices or elements necessarily have a specific orientation or are configured and operated in a specific orientation, and should be understood as not limiting this application.

[0024] The purpose of this application is to provide a drug-carrying scoring balloon and balloon catheter that can effectively avoid drug loss during the process of transporting the drug-carrying scoring balloon to the lesion site, and that can prevent damage to normal vascular tissue during the process of transporting the scoring member to the lesion site.

[0025] To enable those skilled in the art to better understand the technical solution relating to this application, the application will be described in more detail below with reference to the drawings and specific embodiments.

[0026] Specifically, referring to Figures 1 to 27, the drug-carrying scoring balloon disclosed in the embodiments 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. It should be noted that the provision of the scoring member 2 on the outer wall of the balloon body 1 does not 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, the provision of the scoring member 2 on the outer wall of the balloon body 1 should be understood as the scoring member 2 being 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 other members. For example, installing the scoring member 2 on the sheath 3 and installing the sheath 3 on the outer wall of the balloon body 1 similarly achieves 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 structure in the middle and conical structures at both ends, with the cylindrical structure in the middle being the working segment and the conical structures at both 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, and the balloon body 1 can be positioned at the lesion site by the developing ring.

[0029] The scoring member 2 is provided on the cylindrical portion in the middle of the balloon body 1 and may be positioned along an axial direction parallel to the balloon body 1. It can be fixed by being attached with adhesive. In the solution where the scoring member 2 is slidable, it is not necessary to fix the scoring member 2 with adhesive.

[0030] The number of scoring members 2 is n, where n is an integer greater than or equal to 1. If there are multiple scoring members 2, they can be evenly distributed in the circumferential direction on the outer surface of the balloon body 1. The pitch angle in the circumferential direction between any two adjacent scoring members 2 is 360° / n. If there are three scoring members 2, the pitch angle in the circumferential direction between two adjacent scoring members 2 is 120°.

[0031] If there are multiple scoring members 2, there are also multiple sheaths 3, corresponding to each scoring member 2 on a one-to-one basis. The bottom end of the sheath 3 is connected to the balloon body 1, and the tip covers the scoring member 2. In other words, in the initial state, the scoring member 2 is covered by the sheath 3, so that the entire scoring member 2, especially the blade portion of the scoring member 2, is not exposed.

[0032] A first fold is provided at the tip of the sheath 3, opposite the scoring member 2, and the first fold is used to break when the sheath is pressed. Normally, the blade of the scoring member 2 is located on the side of the scoring member 2 that is away from the balloon body 1, and the first fold can be positioned to correspond to the blade of the scoring member 2 so that the sheath 3 can be reliably broken when pressed. When the sheath 3 is pressed, the blade of the scoring member 2 can perform a cutting action against the first fold, assisting in the cutting of the first fold.

[0033] The sheath 3 is provided with a drug storage chamber 301 for storing drugs and a drug discharge passage for releasing drugs to the outside. Both ends of the drug discharge passage communicate with the outside and the drug storage chamber 301, so that if the space in the drug storage chamber 301 becomes smaller or the pressure increases, the drugs stored in the drug storage chamber 301 can be discharged to the outside through the drug discharge passage. The drugs can be injected from the end of the sheath 3, and after injection, it is sealed, and the drugs are 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 site and inflates, the tip of the sheath 3 is pressed against the inner wall of the blood vessel, moving the tip of the sheath 3 toward the balloon body 1, and subsequently gradually reducing the space of the drug storage chamber 301. As the space of the drug storage chamber 301 gradually decreases, the drug stored in the drug storage chamber 301 is discharged through the drug discharge passage to the surface of the balloon body 1, 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 out of the sheath 3.

[0035] The purpose of providing the first fold in the sheath 3 is that, if the balloon body 1 has not reached a predetermined position, the sheath 3 covers the entire scoring member 2, preventing the scoring member 2 from coming into contact with vascular tissue, preventing the scoring member 2 from injuring the human body, and facilitating storage and transport. When the balloon body 1 reaches the lesion site and inflates, and the tip of the sheath 3 is pressed against the inner wall of the blood vessel, the first fold can break, exposing the scoring member 2 from inside the sheath 3. Specifically, the first fold is provided along an axial direction parallel to the balloon body 1, that is, after the sheath 3 breaks along the direction of the first fold, the sheath 3 is divided in half, thereby exposing the scoring member 2 inside.

[0036] The drug-carrying scoring balloon disclosed in the embodiments of this 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 location of a lesion, the scoring member 2 extends out 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 through the drug storage chamber 301 and the drug discharge passage to the surface of the balloon body 1. Compared to conventional drug balloons, this design ensures that normal vascular tissue does not come into contact with the drug during the process of the drug-carrying scoring balloon being transported to the location of the lesion. This design avoids drug loss during the transport process of the rune, and allows drug release only when the drug-carrying scoring balloon reaches the lesion site and the lesion site presses against the sheath 3 after the balloon body 1 has expanded. This ensures that the drug reaches the lesion site in a quantitative or sufficient amount. Furthermore, the design, which adds a sheath 3 to the scoring member 2, protects the scoring member 2 during the transport process of the drug-carrying scoring balloon to the lesion site and during the production process of the drug-carrying scoring balloon, preventing the scoring member 2 from damaging normal tissue.

[0037] Furthermore, the drug discharge passage may be a small-diameter hole; that is, the diameter of the hole on the outlet side of the drug discharge passage should be such that it can be sealed using surface tension. If the drug is a liquid, surface tension is naturally formed on the outlet side surface of the drug discharge passage, and if the sheath 3 is not pressed, the drug will not flow out of the drug discharge passage due to the action of surface tension.

[0038] If the drug discharge passage is a large-diameter hole, the resulting surface tension is insufficient to seal the drug into the drug storage chamber 301 without leakage. Based on this, in specific embodiments, a protective film is provided at the end of the drug discharge passage that communicates with the outside, thus ensuring that the drug does not leak out of the drug discharge passage even under natural conditions, and the drug can only leak out of the drug discharge passage when the sheath 3 is pressed.

[0039] A second fold is provided in the protective membrane to ensure that the drug can be reliably discharged through the drug discharge passage when the sheath 3 is pressed. When the sheath 3 is pressed, the space in the drug storage chamber 301 becomes smaller, the drug presses against the protective membrane, and breaks the second fold. The operating principle of the second fold is similar to that of the first fold, and there may be multiple second folds.

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

[0041] In the initial state, the scoring member 2 is located at the top of the mounting chamber, specifically, the scoring member 2 can be restricted to the top of the mounting chamber by the constraint of the sheath 3. A drug storage chamber 301 for storing drugs is formed between the slide groove member 201 of the scoring member 2 and the slide sheet 304 and / or between the slide sheet 304 and the side wall of the mounting chamber. Because the scoring member 2 is located at the top of the mounting chamber and has a large space between its slide groove member 201 and slide sheet 304, it can accommodate drugs, and there is also a certain amount of space between the slide sheet 304 and the side wall of the mounting chamber for storing drugs.

[0042] When the balloon body 1 reaches the lesion site and inflates, and the tip of the sheath 3 is pressed against the inner wall of the blood vessel, the scoring member 2 moves toward the slide sheet 304 due to the guiding action of the slide groove member 201 (because the slide 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 due to the guiding action of the slide groove member 201), and the space of the drug storage chamber 301 gradually decreases. In other words, the scoring member 2 moves toward the balloon body 1 due to the sliding fit action of the slide groove member 201 and the slide sheet 304, gradually reducing the space between the slide groove member 201 and the slide sheet 304. Also, the slide groove member 201 gradually occupies the space between the slide sheet 304 and the side wall of the mounting chamber, gradually reducing the volume of this space. Therefore, the space of the drug storage chamber 301 gradually decreases 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 tops of the flat plates are connected to the scoring member 2, and the limiting plate is used to abut against the front bottom of the slide sheet 304, thereby restricting 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, a mounting chamber is provided inside the sheath 3, a scoring member 2 is provided at the bottom of the mounting chamber, and a drug storage chamber 301 is formed between the scoring member 2 and the mounting chamber of the sheath 3.

[0045] As shown in Figures 24 to 27, in another specific embodiment, a mounting chamber is provided inside the sheath 3, the mounting 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, the present solution may further include a guide tube 303, which is provided on the side of the sheath 3 and laid on the outer wall of the balloon body 1. One end of the guide tube 303 communicates with the drug discharge passage, and multiple through holes are made in its side wall. There are multiple guide tubes 303, corresponding one-to-one with the drug discharge passage. Multiple through holes are made in the two side walls of the guide tube 303, and when the balloon body 1 inflates and the top of the sheath 3 is pressed against the inner wall of the blood vessel, the space of the drug storage chamber 301 is reduced, and the drug is discharged to the surface of the balloon body 1 through the drug storage chamber 301 - drug discharge passage - guide tube 303.

[0047] To prevent the drug inside from being ejected to the outside due to the light pressure on the sheath 3, the drug discharge passage includes a buffer chamber 302 and a drug discharge through-hole, with both ends of the buffer chamber 302 communicating with the drug storage chamber 301 and the drug discharge through-hole, respectively. Specifically, the buffer chamber 302 and the drug storage chamber 301 can communicate through several small holes. When the balloon body 1 reaches the lesion site and inflates, and the tip of the sheath 3 is pressed against the inner wall of the blood vessel, the drug is discharged to the surface of the balloon body 1 sequentially through the drug storage chamber 301, the buffer chamber 302, and the drug discharge through-hole as the space in the drug storage chamber 301 gradually shrinks. In the initial state, 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 membrane and the second fold are provided at the end portion communicating with the outside of the drug discharge through-hole.

[0048] Furthermore, the number and arrangement of drug discharge passages, buffer chambers, and drug discharge through-holes within them can be designed in various combinations. For example, multiple drug discharge passages may be arranged along the longitudinal direction of the sheath 3, the drug discharge passages may be distributed on both sides of the sheath 3, there may be multiple buffer chambers 302 in each drug discharge passage, the multiple buffer chambers 302 may be in communication with each other, and multiple drug discharge through-holes in each drug discharge passage may be arranged along the height direction of the sheath 3.

[0049] Multiple drug discharge holes are drilled on the side of the sheath 3, starting from top to bottom. These drug discharge holes communicate with the buffer chamber 302, and the drug discharge holes located at different heights expel the drug at different distances. By providing drug discharge holes at different heights, the drug can cover the surface of the balloon body 1 as much 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 the material of the balloon body 1 may include one or more of the following: polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or highly biocompatible polymer materials. Those skilled in the art can set the size and material of the balloon body 1 according to their needs and are not limited to the size range and materials disclosed in the above examples.

[0051] The material of the scoring member 2 may be medical-grade stainless steel, cobalt-chromium alloy, nitinol alloy, or other highly biocompatible metals or alloys, or a highly biocompatible polymer material. 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] Furthermore, embodiments of the present application further disclose a balloon catheter, which includes a catheter base, an inner tube, an outer tube, a drug-carrying scoring balloon in the specific embodiment described above, and a terminal tube. Here, the catheter base has a hollow structure and is provided with a balloon pressure filling and release 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, the guidewire enters from the terminal tube and is withdrawn from the body through the guidewire outlet.

[0053] The near end of the outer tube is connected to a catheter base, and the balloon body 1 is provided at the far end of the outer tube. A balloon filling chamber is formed between the inner wall of the outer tube and the outer wall of the inner tube, and the balloon pressure filling / releasing connection port communicates with the balloon via the balloon filling chamber and is used to inflate or deflate the balloon.

[0054] Clearly, balloon catheters, including the drug-carrying scoring balloons mentioned above, have similar beneficial effects, and their explanation will be omitted here.

[0055] In conventional methods, scoring balloons form a drug coating on their surface, but this method suffers from significant drug loss during the balloon's journey to the lesion, as the drug is easily carried away by the bloodstream and is not absorbed at the location required by the blood vessel. The drug-carrying scoring balloon and balloon catheter according to this solution form a drug storage chamber 301 within the scoring member 2 or sheath 3, and a drug discharge passage within the sheath 3. When the sheath 3 is pressed by a lesion, the scoring member 2 extends out from within the sheath 3, reducing the drug storage space and causing pressure. As a result, the drug is released through the drug discharge passage to the surface of the balloon body 1, which is more advantageous than conventional drug balloons. The design ensures that normal vascular tissue does not come into contact with the drug during the process of transporting the balloon body 1 to the lesion site, thereby avoiding drug loss during the balloon transport process. Drug release is only possible when the balloon body 1 reaches the lesion site and the lesion site presses against the sheath 3 after the balloon body 1 has expanded, allowing the drug to reach the lesion site in a quantitative or sufficient amount. Furthermore, the design of the sheath 3 in the scoring member 2 protects the scoring member 2 during the process of transporting the drug-carrying scoring balloon to the lesion site and during the production of the drug-carrying scoring balloon, preventing the scoring member 2 from damaging normal tissue.

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

[0057] As shown in the present application and claims, unless the context explicitly indicates an exception, words such as “one,” “one,” “one kind,” and / or “the” are not intended to refer to the singular form but may also include the plural form. Generally, the terms “includes” and “inclusion” indicate only the inclusion of clearly identified steps and elements, and these steps and elements do not constitute a single exclusive list; a method or apparatus may also include other steps or elements. An element limited by “includes one…” does not preclude other identical elements from being included in a process, method, product or apparatus that contains the element.

[0058] In the description of the embodiments of this application, unless otherwise specified, " / " means "or," for example, A / B can mean A or B, and "and / or" in this specification is merely to describe the relationship between related objects, indicating that there are three types of relationships, for example, A and / or B can mean the existence of A only, the existence of both A and B, and the existence of B only. Also, in the description of the embodiments of this application, "plural" means two or more.

[0059] In the description of this application, unless otherwise explicitly stated, words such as "install," "attach," and "connect" should be understood in a broad sense, and a person skilled in the art can appropriately determine the specific meaning of these words in this application by referring to the specific content of the technical proposal.

[0060] Each example in this specification is described progressively, with emphasis on the differences between each example and the others. Parts of each example that are the same or similar should be referenced to one another.

[0061] This specification has described the principles and embodiments of the present application using specific examples, but the above description of examples is used solely to help understand the method and central idea of ​​the present application. Those skilled in the art can make various improvements and modifications to the present application without departing from the principles, and these improvements and modifications also fall within the scope of protection of the claims of the present application. [Explanation of Symbols]

[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. It is a drug-carrying scoring balloon, Balloon body (1) and 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) is provided, the bottom end of which is connected to the balloon body (1), the tip of which covers the scoring member (2), a first fold line is provided at the tip of the sheath (3) opposite to the scoring member (2), the first fold line is used to break when the sheath (3) is pressed, a drug storage chamber (301) for storing a drug and a drug discharge passage for releasing a drug to the outside are provided inside the sheath (3), and both ends of the drug discharge passage each include a sheath (3) communicating with the outside and the drug storage chamber (301), 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) is provided at the bottom of the scoring member (2) to slide-fit with the slide sheet (304). In the 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 slide groove member (201) of the scoring member (2) and the slide sheet (304) and / or between the slide sheet (304) and the side wall of the mounting chamber. 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 surface of the flat plates, the top of the flat plates is connected to the scoring member (2), and the limiting plate is used to contact the tip of the slide sheet (304) to achieve restriction. A drug-carrying scoring balloon characterized in that, when the balloon body (1) reaches the lesion site and inflates, and the tip of the sheath (3) is pressed against the inner wall of the blood vessel, the scoring member (2) moves to the slide sheet (304), the space of the drug storage chamber (301) gradually decreases, and as the space of the drug storage chamber (301) gradually decreases, the drug is discharged to 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, causing the tip of the scoring member (2) to extend out from inside the sheath (3).

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

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

4. The drug-carrying scoring balloon according to 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).

5. The drug-carrying scoring balloon according to 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 surface of the scoring member (2).

6. The drug delivery passage includes a buffer chamber (302) and a drug delivery hole, both ends of the buffer chamber (302) communicate with the drug storage chamber (301) and the drug delivery hole, respectively, and when the balloon body (1) reaches the lesion site and inflates, and the tip of the sheath (3) is pressed against the inner wall of the blood vessel, as the space in the drug storage chamber (301) gradually decreases, 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 delivery hole, as described in claim 1.

7. The drug-carrying scoring balloon according to claim 6, characterized in that a plurality of drug discharge passages are arranged 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 plurality, the plurality of buffer chambers (302) are in communication with each other, and / or the drug discharge through-holes in each drug discharge passage are plurality of drug discharge through-holes arranged along the height direction of the sheath (3).

8. A balloon catheter characterized by comprising a drug-carrying scoring balloon according to any one of claims 1 to 7.

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