Cutting balloon and medical equipment

Abstract

The invention relates to the technical field of medical engineering, and discloses a cutting balloon and medical equipment. The cutting balloon comprises a balloon body, a cutter assembly and a hydrophilic coating. The multiple cutter assemblies are arranged on the outer wall of the balloon body and distributed in the circumferential direction of the balloon body at intervals. A hydrophilic coating is arranged on the outer wall of the balloon body. When the cutting balloon moves in a blood vessel, in a wet state, the hydrophilic coating is activated, the hydrophilic coating has high lubricating performance when making contact with blood, the penetrating performance of a cutter assembly of the cutting balloon at the complex tortuous position of the blood vessel can be improved, the trafficability of the cutting balloon is improved, and the passing success rate is increased in the process that the cutting balloon leads to a diseased region or retracts; and the operation safety and convenience are improved.

Description

Technical Field

[0001] The present invention relates to the field of medical engineering technology, and in particular to a cutting balloon and medical equipment. Background Art

[0002] 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.

[0003] 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.

[0004] However, in the existing technology, the cutting balloon has poor permeability in blood vessels and is difficult to pass smoothly through tortuous parts, which may cause damage to the vascular endothelium or product damage, affecting the safety and convenience of the operation.

[0005] Based on this, there is an urgent need for a cutting balloon and medical equipment to solve the above-mentioned problems. Summary of the Invention

[0006] Based on the above, the purpose of the present invention 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 passing ability of the cutting balloon.

[0007] To achieve the above object, the present invention adopts the following technical solutions:

[0008] In one aspect, a cutting balloon is provided, comprising:

[0009] balloon body;

[0010] 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;

[0011] The outer wall of the balloon body is provided with a hydrophilic coating.

[0012] As a preferred technical solution for cutting the balloon, the outer wall of the cutter assembly is provided with a hydrophilic coating.

[0013] As a preferred 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.

[0014] As an optimal technical solution for a cutting balloon, the cutting balloon also includes a first coating, which is arranged on the outer wall of the balloon body and located between the balloon body and the tool assembly. The tool assembly is bonded to the first coating, and the roughness of the first coating is Ra0.8-Ra15.

[0015] As a preferred technical solution for cutting the balloon, a first coating is provided between the hydrophilic coating and the outer wall of the balloon body.

[0016] As a preferred technical solution for cutting the balloon, a coupling agent is provided between the hydrophilic coating and the first coating, and one side of the coupling agent is connected to the first coating and the other side is connected to the hydrophilic coating.

[0017] As a preferred technical solution for cutting the balloon, the first coating is an acid-based oxide.

[0018] As a preferred technical solution for cutting the balloon, the coupling agent is a silane coupling agent, a titanate coupling agent or an aluminate coupling agent.

[0019] As a preferred technical solution for cutting the balloon, the material of the hydrophilic coating is polyacrylamide, polyvinyl pyrrolidone, polyethylene glycol, polyvinyl alcohol or natural polysaccharide.

[0020] On the other hand, a medical device is provided, comprising the cutting balloon described in any of the above schemes.

[0021] The beneficial effects of the present invention are:

[0022] The present invention provides a cutting balloon and medical equipment. 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 the cutting balloon during the process of advancing to the lesion site or withdrawing the cutting balloon, thereby increasing the safety and convenience of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in describing the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without any creative work.

[0024] Figure 1 This is a schematic structural diagram of a cutting balloon provided in Example 1 of the present invention;

[0025] Figure 2 is a cross-sectional view of a cutting balloon provided in Example 1 of the present invention;

[0026] Figure 3 yes Figure 2 Enlarged view at point A;

[0027] Figure 4 This is a partial structural cross-sectional view of the cutting balloon provided in Example 2 of the present invention.

[0028] The following are marked in the figure:

[0029] 1. Balloon body; 2. Cutting tool assembly; 21. Cutting tool holder; 22. Blade; 3. First coating; 4. Hydrophilic coating. DETAILED DESCRIPTION

[0030] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It will be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all structures.

[0031] In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and 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 the present invention in specific circumstances.

[0032] In the present invention, 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. Furthermore, 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.

[0033] In the description of this embodiment, terms such as "upper," "lower," "left," and "right" are used to refer to positions or locations based on those shown in the accompanying drawings. These terms are intended solely to facilitate description and simplify operation, and are not intended to 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 the present invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meaning.

[0034] Example 1

[0035] like Figure 1-Figure 3 As shown, 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 when in contact with blood, which can improve the penetration performance of the tool assembly 2 of the cutting balloon in the complex and tortuous parts of the blood vessel, improve the passability of the cutting balloon, and improve the passing success rate during the process of the cutting balloon reaching the lesion site or withdrawing. Preferably, the outer wall of the tool assembly 2 is provided with a hydrophilic coating 4 to reduce the risk of the tool assembly 2 damaging the blood vessel.

[0036] 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.

[0037] Preferably, 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.

[0038] 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.

[0039] In the prior art, the connection strength between the cutting tool and the balloon is relatively weak. During the movement of the cutting balloon within the blood vessel, the cutting blade is at risk of falling off the balloon in vivo, and the blade falling off 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, multiple 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] Furthermore, if Figure 1 As shown, 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.

[0044] Preferably, the blade holder 21 extends along the axial direction of the balloon body 1, and U-shaped chamfers are provided at both ends of the blade 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.

[0045] Example 2

[0046] like Figure 4 As shown, this embodiment provides a cutting balloon. The structure of the cutting balloon provided in this embodiment is basically the same as that of the embodiment 1, with only some differences. This embodiment will no longer repeat the structure that is the same as that of the embodiment 1.

[0047] 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.

[0048] Preferably, 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.

[0049] Note that the above are only preferred embodiments of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention 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 invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments and may include many other equivalent embodiments without departing from the concept of the present invention. The scope of the present invention is determined by the scope of the appended claims.

Claims

1. A cutting balloon, characterized in that: include: Balloon body (1); A plurality of tool assemblies (2), wherein the 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 walls of the balloon body (1) and the cutter assembly (2) are provided with a hydrophilic coating (4); A first coating (3) is provided between the hydrophilic coating (4) and the outer wall of the balloon body (1); the first coating (3) is located between the balloon body (1) and the tool assembly (2); the tool assembly (2) is bonded to the first coating (3); the first coating (3) is an acidic oxide, and the acidic oxide reacts with the outer wall of the balloon body (1) to form a recess; the roughness of the first coating (3) is Ra0.8-Ra15; 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 is connected to the outer wall of the balloon body (1), and the other side is connected to the hydrophilic coating (4); and / or a coupling agent is provided between the hydrophilic coating (4) and the first coating (3), one side of the coupling agent is connected to the first coating (3), and the other side is connected to the hydrophilic coating (4); The tool assembly (2) comprises a tool holder (21) and a blade (22), wherein the blade (22) is mounted on one side of the tool holder (21), and the tool holder (21) is bonded to the first coating (3) using quick-drying glue, light-curing glue or two-component glue.

2. The cutting balloon according to claim 1, wherein: The acidic oxides are chloric acid-sulfuric acid oxides, chromic acid-acetic acid oxides or anhydrous chromic acid-tetrachloroethane oxides.

3. The cutting balloon according to claim 1, wherein: A plurality of the 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).

4. The cutting balloon according to claim 1, wherein: The coupling agent is a silane coupling agent, a titanate coupling agent or an aluminate coupling agent.

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

6. A medical device, characterized in that: Comprising the cutting balloon according to any one of claims 1-5.

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