Cutting balloon and medical equipment

Abstract

The utility model 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 utility model relates to the technical field of medical engineering, in particular to a cutting balloon and medical equipment. Background Art

[0002] Interventional surgery has been widely used in clinical practice as an important means of treating cardiovascular diseases. When ordinary balloons dilate blood vessels, they will cause geometric fission of the intima and media of the narrowed segment of the blood vessel, leading to compression and rupture of plaques and elastic expansion of blood vessels, which is prone to intima tearing and even acute occlusion. The subsequent elastic retraction and proliferative response to the injury will lead to restenosis.

[0003] The cutting balloon is a special type of balloon that combines micro-cutting technology with balloon dilation. When the balloon is opened, the cutting component is propped outward, cutting the soft plaque in the blood vessel and the endothelium of the blood vessel to a certain extent, making it easier to open the balloon and prop up the blood vessel, using less force, and avoiding the rupture of the blood vessel due to the balloon being propped up too much. Compared with ordinary balloon dilation, the cutting balloon can reduce inflammatory response, elastic retraction, endothelial damage, proliferation response of vascular smooth muscle cells and potential restenosis risk, and obtain more vascular lumen area. It has the potential to improve the success rate of the technology, increase vascular patency and better long-term results.

[0004] However, in the prior art, 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. Utility Model Content

[0006] Based on the above, the purpose of the utility model is to provide a cutting balloon and a medical device, which can improve the penetration performance of the cutter assembly of the cutting balloon in complex and tortuous blood vessels and improve the passability of the cutting balloon.

[0007] In order to achieve the above purpose, the utility model adopts the following technical solutions:

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

[0009] The 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, and 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 a preferred 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 utility model are:

[0022] The utility model 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 performance when in contact with blood, which 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 passing success rate during the process of the cutting balloon passing to the lesion site or withdrawing it, 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 the description of 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 paying any creative work.

[0024] Figure 1 It is a schematic diagram of the structure of the cutting balloon provided in the first embodiment of the utility model;

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

[0026] Figure 3 yes Figure 2 A magnified 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 utility model.

[0028] The following are marked in the figure:

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

[0030] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only the parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0031] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0032] In the present utility model, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0033] In the description of this embodiment, the terms "upper", "lower", "left", "right" and other directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplified operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0034] Embodiment 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 cutter assembly 2 and a hydrophilic coating 4. A plurality of cutter 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 a blood vessel, the hydrophilic coating 4 is activated in a wet state, and has a strong lubricating property in contact with blood, which can improve the penetration performance of the cutter assembly 2 of the cutting balloon in complex and tortuous blood vessels, improve the passability of the cutting balloon, and improve the passing success rate during the process of the cutting balloon passing to the lesion site or withdrawing. Preferably, the outer wall of the cutter assembly 2 is provided with a hydrophilic coating 4 to reduce the risk of the cutter 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 amide groups, ether bonds and hydroxyl groups contained in the molecules absorb water to form a hydration layer, which gives 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] Since the connection strength between the hydrophilic coating 4 and the balloon body 1 is relatively weak, in order to prevent the hydrophilic coating 4 from falling off, in this embodiment, a coupling agent is provided between the hydrophilic coating 4 and the outer wall of the balloon body 1, and 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. The coupling agent is a kind of substance with an amphiphilic structure, and a part of the groups in the molecules of the coupling agent can react with the chemical groups on the surface of the balloon body 1 to form a chemical bond; the other part of the groups have the property of being organic-philic, and can react chemically with organic molecules or produce a strong intermolecular effect, thereby firmly combining the two completely different materials of the hydrophilic coating 4 and the balloon body 1. 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. When the cutting balloon moves in the blood vessel, the cutting blade has the risk of falling off the balloon in the body, and the blade falling off will seriously threaten the patient's life safety. To solve the above problems, the cutting balloon also includes a first coating 3, which 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 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 function of modifying the surface of the balloon body 1, so that the surface roughness is increased. 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 is convenient for 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 intravascular plaque lesions. 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 to be modified, the molecular chains on the surface of the balloon body 1 are broken, and densely packed pits are formed, which changes the surface morphology of the substrate, thereby adjusting the roughness and forming the first coating 3.

[0042] It should be noted that the molding 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 tool assembly 2 includes a knife seat 21 and a blade 22, the blade 22 is installed on one side of the knife seat 21, and the knife seat 21 is bonded to the first coating 3. In this embodiment, the knife seat 21 assembly is distributed in 3-5 rows in the circumferential direction of the balloon body 1, and a plurality of blades 22 are arranged on each row of knife seats 21. The knife seat 21 can be bonded to the first coating 3 by quick-drying glue, light-curing glue or two-component glue.

[0044] Preferably, the cutter holder 21 extends axially along the balloon body 1, and U-shaped chamfers are provided at both ends of the cutter holder 21, so that the blood flow resistance is reduced when the cutting balloon reaches the lesion or during the withdrawal process, thereby improving the passing performance of the cutting balloon.

[0045] Embodiment 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, one side of the coupling agent is connected to the first coating 3, and the other side is 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 used. 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 is described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and 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 cutter assemblies (2), wherein the plurality of cutter assemblies (2) are arranged on the outer wall of the balloon body (1) and are spaced apart along the circumference of the balloon body (1); The outer wall of the balloon body (1) is provided with a hydrophilic coating (4); The cutting balloon further comprises a first coating (3), the first coating (3) being an acidic oxide, the first coating (3) being arranged on the outer wall of the balloon body (1) and being located between the balloon body (1) and the cutter assembly (2), the cutter assembly (2) being bonded to the first coating (3), and the roughness of the first coating (3) being Ra0.8-Ra15; 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).

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

3. The cutting balloon according to claim 1, characterized in that: 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).

4. The cutting balloon according to claim 1, characterized in that: A first coating (3) is provided between the hydrophilic coating (4) and the outer wall of the balloon body (1).

5. The cutting balloon according to claim 4, characterized in that: A coupling agent is provided between the hydrophilic coating (4) and the first coating (3), and one side of the coupling agent is connected to the first coating (3) and the other side is connected to the hydrophilic coating (4).

6. The cutting balloon according to claim 3, characterized in that: The coupling agent is a silane coupling agent, a titanate coupling agent or an aluminate coupling agent.

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

8. A medical device, characterized in that: Comprising a cutting balloon as described in any one of claims 1-7.

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