Cutting balloon and medical device

Abstract

Provided are a cutting balloon and a medical device. The cutting balloon comprises a balloon body (1), a cutter assembly (2), and a hydrophilic coating (4). A plurality of cutter assemblies (2) are arranged on an outer wall of the balloon body (1) and are distributed at intervals in a circumferential direction of the balloon body (1). The hydrophilic coating (4) is arranged on the outer wall of the balloon body (1). When the cutting balloon moves in a blood vessel, the hydrophilic coating (4) is activated under wet conditions and exhibits strong lubricating performance upon contact with blood, which enhances the navigability of the cutter assemblies (2) of the cutting balloon at complex and tortuous segments of the blood vessel, thereby improving the success rate of the passing through of the balloon and improving the safety and convenience of surgeries.

Description

Cutting balloons and medical devices

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 25, 2023 with application number 202311805275.8, and the Chinese patent application filed with the China Patent Office on December 25, 2023 with application number 202323554745.6, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of medical engineering technology, and in particular to a cutting balloon and medical equipment. Background Art

[0003] Interventional surgery is widely used clinically as an important treatment for cardiovascular disease. When conventional balloons are used to dilate blood vessels, they can cause geometric fission of the intima and media within the narrowed segment, leading to plaque compression and rupture and elastic expansion of the vessel. This can easily cause intimal tears and even acute occlusion. The subsequent elastic recoil and proliferative response to the injury can lead to restenosis.

[0004] A cutting balloon is a specialized type of balloon that combines micro-cutting technology with balloon expansion. As the balloon opens, the cutting component expands outward, cutting the soft plaque and endothelium within the vessel to a certain extent. This makes it easier to open the balloon and expand the vessel, requiring less force and avoiding rupture due to over-expansion of the balloon. Compared to conventional balloon expansion, cutting balloons can reduce inflammation, elastic recoil, intimal damage, vascular smooth muscle cell proliferation, and the potential risk of restenosis. They also increase the area of ​​the vascular lumen, potentially improving technical success rates, increasing vascular patency, and achieving better long-term outcomes.

[0005] However, in related technologies, the cutting balloon has poor permeability within blood vessels and is difficult to pass smoothly through tortuous areas, which may cause damage to the vascular endothelium or product damage, affecting the safety and convenience of the operation.

[0006] Based on this, there is an urgent need for a cutting balloon and medical equipment to solve the above-mentioned problems.

[0007] Summary of the Invention

[0008] Based on the above, the purpose of this application is to provide a cutting balloon and medical equipment, which can improve the penetration performance of the cutting balloon's tool assembly in complex and tortuous blood vessels and improve the passability of the cutting balloon.

[0009] To achieve the above objectives, this application adopts the following technical solutions:

[0010] In one aspect, a cutting balloon is provided, comprising:

[0011] balloon body;

[0012] A plurality of cutter assemblies, wherein the plurality of cutter assemblies are arranged on the outer wall of the balloon body and are spaced apart along the circumference of the balloon body;

[0013] The outer wall of the balloon body is provided with a hydrophilic coating.

[0014] As an optional technical solution for cutting the balloon, the outer wall of the cutter assembly is provided with a hydrophilic coating.

[0015] As an optional technical solution for cutting the balloon, a coupling agent is provided between the hydrophilic coating and the outer wall of the balloon body, wherein one side of the coupling agent is connected to the outer wall of the balloon body and the other side is connected to the hydrophilic coating.

[0016] As an optional technical solution for the cutting balloon, the cutting balloon further includes a first coating, which is disposed on the outer wall of the balloon body.

[0017] As an optional technical solution for cutting the balloon, the first coating is located between the balloon body and the cutter assembly, and the cutter assembly is bonded to the first coating.

[0018] As an optional technical solution for cutting the balloon, the first coating is provided between the hydrophilic coating and the outer wall of the balloon body.

[0019] As an optional technical solution for cutting the balloon, a coupling agent is provided between the hydrophilic coating and the first coating, wherein one side of the coupling agent is connected to the first coating and the other side is connected to the hydrophilic coating.

[0020] As an optional technical solution for cutting the balloon, the first coating is an acid-based oxide.

[0021] As an optional technical solution for cutting the balloon, the coupling agent is a silane coupling agent, a titanate coupling agent or an aluminate coupling agent.

[0022] As an optional technical solution for cutting the balloon, the material of the hydrophilic coating is polyacrylamide, polyvinyl pyrrolidone, polyethylene glycol, polyvinyl alcohol or natural polysaccharide.

[0023] As an optimal technical solution for cutting balloons, the first coating has the function of modifying the surface of the balloon body, thereby increasing the surface roughness of the balloon body.

[0024] As an optimal technical solution for cutting balloons, the roughness of the first coating is Ra0.8-Ra15.

[0025] As an optimal technical solution for cutting the balloon, the tool assembly includes a tool holder and a blade, the blade is mounted on one side of the tool holder, and the tool holder is bonded to the first coating.

[0026] As an optimal technical solution for cutting the balloon, the tool assembly includes a tool holder and a blade. The tool holder extends along the axial direction of the balloon body, and both ends of the tool holder are provided with U-shaped chamfers.

[0027] On the other hand, a medical device is provided, comprising the cutting balloon described in any of the above schemes.

[0028] The beneficial effects of this application are:

[0029] The present application provides a cutting balloon and medical device. When the cutting balloon moves in a blood vessel, the hydrophilic coating is activated in a wet state, and has strong lubrication properties when in contact with blood. This can improve the penetration performance of the tool assembly of the cutting balloon in complex and tortuous blood vessels, improve the passability of the cutting balloon, and improve the success rate of passage during the process of the cutting balloon reaching the lesion site or retracting it, thereby increasing the safety and convenience of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following is a brief introduction to the drawings required for use in the description of the embodiments of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present application and these drawings without any creative work.

[0031] FIG1 is a schematic structural diagram of a cutting balloon provided in Example 1 of the present application;

[0032] FIG2 is a cross-sectional view of a cutting balloon provided in Example 1 of the present application;

[0033] FIG3 is an enlarged view of FIG2 at point A;

[0034] FIG4 is a partial structural cross-sectional view of the cutting balloon provided in Example 2 of the present application.

[0035] The following are marked in the figure:

[0036] 1. Balloon body; 2. Cutting tool assembly; 21. Cutting tool holder; 22. Blade; 3. First coating; 4. Hydrophilic coating. DETAILED DESCRIPTION

[0037] The present application will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are intended only to illustrate the present application and are not intended to limit the present application. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions of the present application, not all of the structures.

[0038] In the description of this application, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and can refer to internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0039] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0040] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., regarding orientations or positions, are based on the orientations or positions shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meanings.

[0041] Example 1

[0042] As shown in Figures 1 to 3, this embodiment provides a medical device, including a cutting balloon, which includes a balloon body 1, a tool assembly 2 and a hydrophilic coating 4. A plurality of tool assemblies 2 are arranged on the outer wall of the balloon body 1 and are distributed at intervals along the circumference of the balloon body 1; the outer wall of the balloon body 1 is provided with a hydrophilic coating 4. When the cutting balloon moves in the blood vessel, in a wet state, the hydrophilic coating 4 is activated and has strong lubrication properties in contact with blood, which can improve the penetration performance of the tool assembly 2 of the cutting balloon in complex and tortuous blood vessels, improve the passability of the cutting balloon, and improve the success rate of the passage when the cutting balloon is directed to the lesion site or withdrawn. Optionally, the outer wall of the tool assembly 2 is provided with a hydrophilic coating 4 to reduce the risk of damage to the blood vessel by the tool assembly 2.

[0043] In this embodiment, the material of the hydrophilic coating 4 is polyacrylamide, polyvinyl pyrrolidone, polyethylene glycol, polyvinyl alcohol or natural polysaccharides and derivatives. The reason why the hydrophilic coating 4 increases lubricity is that the material of the hydrophilic coating 4 is a hydrophilic polymer. The hydrophilic groups contained in the molecules include amide groups, ether bonds and hydroxyl groups, which absorb water to form a hydration layer, giving the hydrophilic coating 4 hydrophilicity and lubricity.

[0044] Optionally, the outer wall of the cutter assembly 2 is provided with a hydrophilic coating 4, thereby increasing the overall passing performance of the cutting balloon and preventing the cutter assembly 2 from damaging the blood vessel.

[0045] Because the connection between the hydrophilic coating 4 and the balloon body 1 is relatively weak, to prevent the hydrophilic coating 4 from falling off, in this embodiment, a coupling agent is disposed between the hydrophilic coating 4 and the outer wall of the balloon body 1. One side of the coupling agent is connected to the outer wall of the balloon body 1, and the other side is connected to the hydrophilic coating 4. A coupling agent is a substance with an amphiphilic structure. Some groups in the coupling agent's molecules can react with chemical groups on the surface of the balloon body 1 to form chemical bonds; other groups have organic affinity and can chemically react with organic molecules or produce strong intermolecular interactions, thereby firmly bonding the two completely different materials, the hydrophilic coating 4 and the balloon body 1. This embodiment improves the connection strength between the hydrophilic coating 4 and the balloon body 1 through the transition of the coupling agent. In this embodiment, the coupling agent is a silane coupling agent, a titanate coupling agent, or an aluminate coupling agent.

[0046] In the related art, the connection strength between the cutting tool and the balloon is relatively weak. During the movement of the cutting balloon in the blood vessel, the cutting blade is at risk of falling off the balloon in the body, and the falling of the blade will seriously threaten the patient's life. To solve the above problem, the cutting balloon also includes a first coating 3. The first coating 3 is arranged on the outer wall of the balloon body 1 and is located between the balloon body 1 and the tool assembly 2. The tool assembly 2 is bonded to the first coating 3, and the roughness of the first coating 3 is Ra0.8-Ra15. Specifically, a plurality of tool assemblies 2 are arranged in a ring around the balloon body 1; the first coating 3 is arranged on the outer wall of the balloon body 1 and is located between the balloon body 1 and the tool assembly 2. The tool assembly 2 is bonded to the first coating 3, and the roughness of the first coating 3 is Ra0.8-Ra15.

[0047] By providing a first coating 3 on the outer wall of the balloon body 1, the first coating 3 has the effect of modifying the surface of the balloon body 1, thereby increasing the surface roughness. The roughness of the first coating 3 is Ra0.8-Ra15, which increases the roughness of the outer wall of the balloon body 1. Therefore, when the tool assembly 2 is bonded to the first coating 3, the bonding strength between the tool assembly 2 and the balloon body 1 can be enhanced, the adhesion of the tool assembly 2 can be improved, and the risk of falling off in the body can be reduced. When the cutting balloon moves in the blood vessel, the balloon body 1 is in a contracted state, which facilitates the movement of the cutting balloon. When the cutting balloon moves to the lesion site, the balloon body 1 expands, and the tool assembly 2 cuts the plaque lesions in the blood vessel. The cutting balloon has good penetration performance, the installation of the tool assembly 2 is more secure, and the tensile strength of the tool assembly 2 and the balloon body 1 is increased from 5N to 10N, which reduces the risk of falling off in the body and has a higher safety factor.

[0048] In this embodiment, the first coating 3 is an acidic oxide, specifically including but not limited to chloric acid-sulfuric acid, chromic acid-acetic acid, or anhydrous chromic acid-tetrachloroethane. The formation principle of the first coating 3 is that the acidic oxide reacts with the outer wall of the balloon body 1, modifying it. The molecular chains on the surface of the balloon body 1 break, forming dense pits, changing the surface morphology of the substrate, and thus adjusting the roughness, forming the first coating 3.

[0049] It should be noted that the forming process of the first coating 3, the coupling agent and the hydrophilic coating 4 adopts one process of dipping, brushing and spraying or a combination of multiple processes, and then is cured by UV or electron beam.

[0050] Furthermore, as shown in Figure 1, the cutter assembly 2 includes a cutter holder 21 and a blade 22. The blade 22 is mounted on one side of the cutter holder 21, and the cutter holder 21 is bonded to the first coating 3. In this embodiment, the cutter holders 21 are arranged in 3-5 rows circumferentially around the balloon body 1, with each row of cutter holders 21 provided with multiple blades 22. The cutter holders 21 can be bonded to the first coating 3 using quick-drying glue, light-curing glue, or two-component glue.

[0051] Optionally, the knife holder 21 extends axially along the balloon body 1, and U-shaped chamfers are provided at both ends of the knife holder 21, so that the cutting balloon can reduce blood flow resistance on the way to the lesion or during the withdrawal process, thereby improving the passing performance of the cutting balloon.

[0052] Example 2

[0053] As shown in FIG4 , this embodiment provides a cutting balloon. The structure of the cutting balloon provided in this embodiment is basically the same as that of the first embodiment, with only some differences. This embodiment will not repeat the structure that is the same as that of the first embodiment.

[0054] In this embodiment, a first coating 3 is provided between the hydrophilic coating 4 and the outer wall of the balloon body 1. By increasing the roughness of the surface of the balloon body 1, the contact area between the hydrophilic coating 4 and the surface of the balloon body 1 is increased, thereby improving the connection strength between the hydrophilic coating 4 and the outer wall of the balloon body 1 and preventing the hydrophilic coating 4 from falling off.

[0055] Optionally, a coupling agent is provided between the hydrophilic coating 4 and the first coating 3, with one side of the coupling agent connected to the first coating 3 and the other side connected to the hydrophilic coating 4. This embodiment improves the connection strength between the hydrophilic coating 4 and the first coating 3 through the transition of the coupling agent.

[0056] Note that the above are only preferred embodiments of the present application and the technical principles employed. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and that various obvious changes, readjustments, and substitutions can be made by those skilled in the art without departing from the scope of protection of the present application. Therefore, although the present application has been described in more detail through the above embodiments, the present application is not limited to the above embodiments and may include many other equivalent embodiments without departing from the scope of the present application. The scope of the present application is determined by the scope of the appended claims.

Claims

1. A cutting balloon, comprising: A balloon body (1); A plurality of cutter assemblies (2), the plurality of cutter assemblies (2) being disposed on the outer wall of the balloon body (1) and spaced circumferentially along the balloon body (1); The outer wall of the balloon body (1) is provided with a hydrophilic coating (4).

2. The cutting balloon according to claim 1, wherein The outer wall of the cutter assembly (2) is provided with the hydrophilic coating (4).

3. The cutting balloon according to claim 1, wherein, A coupling agent is provided between the hydrophilic coating (4) and the outer wall of the balloon body (1), one side of the coupling agent being connected to the outer wall of the balloon body (1) and the other side being connected to the hydrophilic coating (4).

4. The cutting balloon according to claim 1, further comprising a first coating (3), the first coating (3) being disposed on the outer wall of the balloon body (1).

5. The cutting balloon according to claim 4, wherein, The first coating (3) is located between the balloon body (1) and the cutter assembly (2), and the cutter assembly (2) is bonded to the first coating (3).

6. The cutting balloon according to claim 4, wherein, The first coating (3) is provided between the hydrophilic coating (4) and the outer wall of the balloon body (1).

7. The cutting balloon according to claim 6, wherein, A coupling agent is provided between the hydrophilic coating (4) and the first coating (3), one side of the coupling agent being connected to the first coating (3) and the other side being connected to the hydrophilic coating (4).

8. The cutting balloon according to claim 4, wherein The first coating (3) is an acid-based oxide.

9. The cutting balloon according to claim 3, wherein, The coupling agent is a silane-based coupling agent, a titanate-based coupling agent or an aluminate coupling agent.

10. The cutting balloon according to claim 1, wherein, The material of the hydrophilic coating (4) is polyacrylamide, polyvinylpyrrolidone, polyethylene glycol, polyvinyl alcohol or natural polysaccharide.

11. The cutting balloon according to claim 4, wherein, The first coating (3) has the effect of surface modification on the balloon body (1), increasing the surface roughness of the balloon body (1).

12. The cutting balloon according to claim 4, wherein, The roughness of the first coating (3) is Ra0.8 - Ra15.

13. The cutting balloon according to claim 5, wherein, The cutter assembly (2) includes a tool holder (21) and a blade (22), the blade (22) being mounted on one side of the tool holder (21), and the tool holder (21) being bonded to the first coating (3).

14. The cutting balloon according to claim 1, wherein, The cutter assembly (2) includes a tool holder (21) and a blade (22), the tool holder (21) extending along the axial direction of the balloon body (1), and both ends of the tool holder (21) being provided with U-shaped chamfers.

15. A medical device, comprising the cutting balloon according to any one of claims 1 - 14.

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