A balloon with a blade

Abstract

This invention relates to the field of medical device technology and discloses a balloon with a blade, comprising a blade assembly and a balloon. The blade assembly includes a blade, a blade holder, and a fixing seat arranged along the axial direction of the balloon. The blade and the blade holder are locked together by a connecting mechanism. The fixing seat is mounted on the outer wall of the balloon, and the bottom area of ​​the fixing seat is larger than the bottom area of ​​the blade holder. The blade holder is mounted on the fixing seat. Because the bottom area of ​​the fixing seat is larger than that of the blade holder, the fixing seat increases the contact area between the blade assembly and the balloon. When the balloon passes through a tortuous section within the blood vessel, the balloon bends. Compared with the prior art, when the blade assembly is subjected to the same force, the stress between the fixing seat and the balloon is smaller, which can reduce the risk of stress cracking at the junction of the fixing seat and the balloon.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a balloon with a blade. Background Technology

[0002] Interventional surgery, as an important means of treating cardiovascular diseases, has been widely used in clinical practice. When a conventional balloon dilates a blood vessel, it causes geometrical fission of the intima and media of the narrowed segment of the vessel, leading to plaque compression and rupture, as well as elastic dilation of the vessel. This can easily result in intimal tearing or even acute occlusion. The subsequent elastic recoil and proliferative response to the damage can lead to restenosis.

[0003] Blade-embedded balloons are a special type of balloon that combines micro-dissection technology with balloon dilation. As the balloon opens, the cutting component expands outwards, cutting soft plaques and the vascular intima to a certain extent. This makes the balloon easier to open, the vessel easier to dilate, and requires less force, preventing vascular rupture due to over-inflation. Compared to conventional balloon dilation, blade-embedded balloons can reduce inflammation, elastic recoil, intimal damage, vascular smooth muscle cell proliferation, and the potential risk of restenosis. They also offer the ability to obtain more vascular lumen area, potentially improving technical success rates, increasing vascular patency, and leading to better long-term outcomes.

[0004] Existing cutting assemblies on balloons with blades include a blade holder and a cutting blade, with the cutting blade mounted on the blade holder, which is directly mounted on the balloon. However, the contact area between the blade holder and the balloon is small, and the stress between them is high when the cutting blade is cutting, which can easily lead to cracking at the connection between the blade holder and the balloon.

[0005] Therefore, there is an urgent need for a balloon with a blade to solve the aforementioned problems. Summary of the Invention

[0006] Based on the above, the purpose of this invention is to provide a balloon with a blade, which reduces the stress between the fixation base and the balloon, thereby reducing the risk of stress cracking at the junction of the fixation base and the balloon.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] A balloon with a blade includes a blade assembly and a balloon. The blade assembly includes a blade, a blade holder, and a fixing seat arranged along the axial direction of the balloon. The blade and the blade holder are locked to each other by a connecting mechanism. The fixing seat is installed on the outer wall of the balloon, and the blade holder is installed on the fixing seat. The bottom area of ​​the fixing seat is larger than the bottom area of ​​the blade holder.

[0009] As a preferred embodiment of a balloon with a blade, the connecting mechanism includes:

[0010] The blade has a plurality of first slots spaced apart along its length, and each first slot has an opening on one side of the blade's bottom.

[0011] and

[0012] The tool holder has a first locking portion arranged along its length;

[0013] The first snap-fit ​​part corresponds to the first card slot one by one, and the first snap-fit ​​part enters the first card slot through the opening.

[0014] As a preferred technical solution for a balloon with a blade, the blade holder is provided with a receiving groove, the first locking part is disposed in the receiving groove, the two ends of the receiving groove are respectively provided with a second locking groove, the two ends of the blade bottom are respectively provided with a second locking part, and the second locking part is locked in the second locking groove.

[0015] As a preferred technical solution for a balloon with a blade, the first locking part has the same shape as the first locking groove; the first locking part and / or the first locking groove is waist-shaped, I-shaped, T-shaped or spherical.

[0016] As a preferred technical solution for a balloon with a blade, the material hardness of the fixing seat is between that of the blade holder and the balloon.

[0017] As a preferred technical solution for a balloon with blades, the blade holder has U-shaped rounded corners at both ends.

[0018] As a preferred technical solution for a balloon with a blade, the roughness of the blade tip is not greater than Ra0.8;

[0019] The roughness of the blade's underside is no greater than Ra3.2.

[0020] As a preferred technical solution for a balloon with a blade, the blade holder is bonded to or snapped onto the fixing seat;

[0021] The mounting base is heat-fused, bonded, or snapped onto the balloon.

[0022] As a preferred embodiment of a balloon with blades, there are multiple blade assemblies, which are evenly spaced along the circumference of the balloon.

[0023] As a preferred technical solution for a balloon with blades, the fixing base is equipped with multiple sets of blade holders and blades at intervals along the length direction, and the blade holders and blades correspond one-to-one.

[0024] As a preferred embodiment of a balloon with a blade, the fixing seat extends continuously along the axial direction of the balloon, and the length of the fixing seat matches the length of the main body segment of the balloon.

[0025] The beneficial effects of this invention are as follows:

[0026] This invention provides a balloon with a blade. By providing a stress-dispersing fixing seat between the balloon and the blade holder, the fixed seat increases the contact area between the blade assembly and the balloon due to its larger base area compared to the blade holder. This causes the balloon to bend as it passes through tortuous sections within the blood vessel. Furthermore, the fixing seat is made of a material with a hardness between that of the balloon and the blade holder, which provides stress buffering. Compared to existing technologies, when the blade assembly is subjected to the same force, the stress between the fixing seat and the balloon is lower, avoiding large local deformation of the balloon caused by stress concentration and reducing the risk of stress cracking at the junction of the fixing seat and the balloon. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the structure of a balloon with a blade provided in a specific embodiment of the present invention;

[0029] Figure 2 yes Figure 1 Enlarged view at point A;

[0030] Figure 3 This is an exploded view of the blade and tool holder provided in a specific embodiment of the present invention;

[0031] Figure 4 This is a schematic diagram of the balloon in a folded state provided in a specific embodiment of the present invention.

[0032] The markings in the image are as follows:

[0033] 1. Tool assembly; 11. Blade; 111. First slot; 1111. Opening; 112. Tool tip; 113. Tool base; 114. Second locking part; 12. Tool holder; 121. First locking part; 122. Rounded corner; 123. Receiving groove; 124. Second slot; 13. Fixing base;

[0034] 2. Balloon; 21. Balloon wings. Detailed Implementation

[0035] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, and not all of the structures.

[0036] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0037] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0038] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. In addition, the terms "first" and "second" are used only for distinction in description and have no special meaning.

[0039] like Figures 1-3 As shown, this embodiment provides a balloon with a blade, which includes a blade assembly 1 and a balloon 2. The blade assembly 1 includes a blade 11, a blade holder 12, and a fixing seat 13.

[0040] Specifically, the cutting tool assembly 1 includes a blade 11, a blade holder 12, and a fixing seat 13 arranged along the axial direction of the balloon 2. The blade 11 and the blade holder 12 are locked together by a connecting mechanism. The fixing seat 13 is installed on the outer wall of the balloon 2, and the bottom area of ​​the fixing seat 13 is larger than the bottom area of ​​the blade holder 12. The blade holder 12 is mounted on the fixing seat 13. Because the bottom area of ​​the fixing seat 13 is larger than that of the blade holder 12, the fixing seat 13 increases the contact area between the cutting tool assembly 1 and the balloon 2. When the balloon 2 passes through a tortuous section within the blood vessel, the balloon 2 bends. Compared with the prior art, when the cutting tool assembly 1 is subjected to the same force, the stress between the fixing seat 13 and the balloon 2 is smaller, which can reduce the risk of stress cracking at the junction of the fixing seat 13 and the balloon 2.

[0041] Preferably, the fixing seat 13 extends continuously along the axial direction of the balloon 2, and the length of the fixing seat 13 is matched with the length of the main body section of the balloon 2 (excluding the conical sections at both ends), and is nearly the same, so as to maximize the contact area between the cutter assembly 1 and the balloon 2, and to maximize the dispersion of stress between the cutter assembly 1 and the balloon 2 to prevent cracking.

[0042] In existing technologies, the cutting blade has poor flexibility and poor passage through blood vessels. It is difficult to pass smoothly through tortuous areas, which may cause damage to the vascular endothelium or damage to the product, affecting the safety and convenience of the surgery. Furthermore, there is a risk that the cutting blade may detach inside the body, which could seriously threaten the patient's life.

[0043] To address the aforementioned issues, the connecting mechanism includes a blade 11 with multiple first slots 111 spaced along its length. Each first slot 111 has an opening 1111 on one side of the blade base 113. The structure of the first slots 111 and the opening 1111 increases the flexibility of the blade 11, allowing the blade 11 and balloon 2 to maintain better curvature consistency, improving the penetration performance of the balloon with the blade in complex and tortuous blood vessels, and reducing the risk of brittle fracture of the blade 11. The blade holder 12 has multiple first engaging parts 121 along its length, each corresponding to one of the first slots 111. The first engaging parts 121 enter the first slots 111 through the openings 1111, thus fixing the blade 11 to the blade holder 12. The multiple first engaging parts 121 simultaneously engage with the first slots 111, and the interlocking connection between the blade 11 and the blade holder 12 enhances the bonding strength between them, reducing the risk of the blade 11 falling out of the body.

[0044] In this embodiment, the first locking portion 121 and / or the first locking groove 111 are, but not limited to, waist-shaped, I-shaped, T-shaped, or spherical, etc., all of which can achieve interlocking between the first locking groove 111 and the first locking portion 121. More preferably, the shape of the first locking portion 121 is the same as the shape of the first locking groove 111 to prevent the blade 11 from moving along the length direction relative to the blade holder 12.

[0045] To more firmly secure the blade 11 and distribute the stress transmitted from it, the material hardness of the fixing seat 13 is preferably between that of the blade holder 12 and the balloon 2. During the cutting and stress-bearing process of the blade 11, the fixing seat 13 provides a stress transition buffer between the blade holder 12 and the balloon 2, especially reducing the risk of stress cracking at the interface between the fixing seat 13 and the balloon 2 when the balloon 2 bends. Furthermore, when the balloon 2 passes through curves, the blade 11 and the balloon 2 can better maintain consistent curvature, improving the balloon 2's passability.

[0046] Preferably, the blade 11 is made of stainless steel or alloy steel, such as 304 stainless steel, UHB AEB-L, SS716 stainless steel, or 440 stainless steel. The length of the blade 11 is between 2.0 and 20.0 mm. More preferably, the length of the blade 11 is between 3.0 and 6.0 mm. The surface roughness of the blade 11 decreases from the blade base 113 to the blade tip 112. The roughness of the blade tip 112 is no greater than Ra0.8 to ensure good cutting performance of the blade tip 112, and the roughness of the blade base 113 is no greater than Ra3.2 to increase the friction at the joint between the blade 11 and the blade holder 12 and improve the joint strength.

[0047] The length of the tool holder 12 is between 2.0 and 20.0 mm, and the width is between 0.1 and 3.0 mm. The material is including but not limited to polyamide, polyethylene, or polyurethane. The tool holder 12 is capable of a certain degree of deformation. When the first locking part 121 passes through the opening 1111, it contracts. After the first locking part 121 enters the first slot 111, the deformation is restored, so that the first locking part 121 is locked into the first slot 111.

[0048] The fixing seat 13 serves as a medium component connecting the knife holder 12 and the balloon 2. It has a length of 2.0-25.0 mm and a width of 0.1-5.0 mm. The material of the knife holder 122 includes, but is not limited to, polyamide, polyethylene, or polyurethane.

[0049] The balloon 2 is a non-compliant or semi-compliant balloon, made of materials including but not limited to polyamide, polyether block polyamide, etc., and is made of a single layer material.

[0050] In this embodiment, the blade 11 is made of UHB AEB-L material and has a length of 4.2 mm. It is connected to the blade holder 12 via an interlocking structure. The blade holder 12 is made of polyethylene and has a width of 0.2 mm. It is also connected to the blade holder 12 via an interlocking structure. The blade holder 12 is made of polyamide and is bonded to the balloon 2 using UV-cured adhesive. The balloon 2 is a non-compliant balloon made of polyamide.

[0051] In other embodiments, the blade 11 is made of SS716 stainless steel and can be 4.8 mm long. It is connected to the blade holder 12 via an interlocking structure. The blade holder 12 is made of polyethylene and can be 0.3 mm wide. It is connected to the blade holder 122 via an interlocking structure. The blade holder 12 is made of polyamide and is bonded to the balloon 2 with quick-drying adhesive. The balloon 2 is a semi-compliant balloon made of polyether block polyamide.

[0052] More preferably, the two ends of the blade holder 12 are provided with U-shaped rounded corners 122, which reduces blood flow resistance and improves the penetration performance of the balloon 2 during its journey to the lesion or during its retraction.

[0053] Furthermore, the tool holder 12 is provided with a receiving groove 123, and a first engaging part 121 is provided in the receiving groove. A second engaging groove 124 is provided at both ends of the receiving groove 123. The blade 11 gradually thins from the blade bottom 113 to the blade tip 112. A second engaging part 114 is provided at both ends of the blade bottom 113. When the blade 11 is installed in the receiving groove 123, the tool holder 12 can undergo a certain deformation so that the first engaging part 121 engages with the first engaging groove 111 and the second engaging part 114 engages with the second engaging groove 124, thereby further improving the connection strength between the blade 11 and the tool holder 12 and preventing the blade 11 from moving relative to the tool holder 12.

[0054] Preferably, the blade holder 12 is bonded to or snapped onto the fixing base 13. When the blade holder 12 is bonded to the fixing base 13 with adhesive, the adhesive includes, but is not limited to, quick-drying adhesive, UV-curing adhesive, or two-component adhesive. The fixing base 13 is heat-fused, bonded, or snapped onto the balloon 2. When the fixing base 13 is heat-fused to the balloon 2, the heat-fused connection can be laser welding, ultrasonic welding, etc. When the fixing base 13 is bonded to the balloon 2 with adhesive, the adhesive includes, but is not limited to, quick-drying adhesive, UV-curing adhesive, or two-component adhesive.

[0055] Preferably, there are multiple blade assemblies 1, which are evenly spaced along the circumference of the balloon 2. In this embodiment, there are 3-5 blade assemblies 1.

[0056] More preferably, the same tool assembly 1 has multiple tool holders 12 and blades 11, which correspond one-to-one; the multiple tool holders 12 are arranged in a straight line and installed at intervals on the fixed base 13. When multiple tool holders 12 need to be installed in each row of fixed bases 13, the interlocking structure of the tool holders 12 and the fixed base 13 allows these tool holders 12 with pre-installed blades 11 to be arranged in a straight line. When the balloon 2 is folded, there are fewer circumferential tool holders 12 and blades 11 on the balloon 2, which is conducive to folding and provides better protection for the blades 11. Furthermore, the gap between adjacent tool holders 12 on each fixed base 13 is 0.1-2mm. More preferably, the gap between adjacent tool holders 12 is 0.3-0.6mm, which on the one hand ensures the effective cutting length of the blades 11, and on the other hand improves the flexibility of the balloon 2 in passing through curves, thereby improving the product's passability.

[0057] It should be noted that, as Figure 4 As shown, the balloon 2 with blade 11 is in a folded state before reaching the lesion inside the blood vessel. Blade 11 is protected by two adjacent balloon wings 21 to prevent it from scratching the blood vessel. After reaching the lesion, as the balloon 2 inflates, blade 11 is exposed on the surface of the balloon 2 and cuts the lesion to a certain extent, effectively avoiding random tearing of the intima and media, reducing inflammatory response, elastic recoil, reducing the potential risk of restenosis, and obtaining more vascular lumen area.

[0058] Note that the above description is merely a preferred embodiment 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 various obvious changes, readjustments, and substitutions can be made 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 which is determined by the scope of the appended claims.

Claims

1. A balloon with a blade, characterized in that, The device includes a cutting tool assembly (1) and a balloon (2). The cutting tool assembly (1) includes a blade (11), a blade holder (12), and a fixing seat (13) arranged along the axial direction of the balloon (2). The blade (11) and the blade holder (12) are locked to each other by a connecting mechanism. The fixing seat (13) is installed on the outer wall of the balloon (2). The blade holder (12) is installed on the fixing seat (13). The bottom area of ​​the fixing seat (13) is larger than the bottom area of ​​the blade holder (12). The material hardness of the fixed seat (13) is between that of the knife seat (12) and the material hardness of the balloon (2); the balloon (2) is a non-compliant or semi-compliant balloon.

2. The balloon with blade according to claim 1, characterized in that, The connecting mechanism includes: The blade (11) has a plurality of first slots (111) spaced apart along its length, and the first slots (111) have an opening (1111) on one side of the blade bottom (113) of the blade (11). and The tool holder (12) has a plurality of first snap-fit ​​portions (121) arranged along the length direction; The first snap-fit ​​part (121) corresponds one-to-one with the first card slot (111), and the first snap-fit ​​part (121) enters the first card slot (111) through the opening (1111).

3. The balloon with a blade according to claim 2, characterized in that, The blade holder (12) is provided with a receiving groove (123), the first snap-fit ​​part (121) is provided in the receiving groove (123), the two ends of the receiving groove (123) are respectively provided with a second snap-fit ​​groove (124), the two ends of the blade bottom (113) are respectively provided with a second snap-fit ​​part (114), and the second snap-fit ​​part (114) is snapped into the second snap-fit ​​groove (124).

4. The balloon with a blade according to claim 2, characterized in that, The first snap-fit ​​portion (121) has the same shape as the first slot (111); the first snap-fit ​​portion (121) and / or the first slot (111) is waist-shaped, I-shaped, T-shaped or spherical.

5. The balloon with a blade according to any one of claims 1-4, characterized in that, The two ends of the tool holder (12) are provided with U-shaped rounded corners (122).

6. The balloon with a blade according to any one of claims 1-4, characterized in that, The roughness of the blade tip (112) of the blade (11) is not greater than Ra0.8; The roughness of the blade (113) at the bottom of the blade (11) is no greater than Ra3.

2.

7. The balloon with a blade according to any one of claims 1-4, characterized in that, The blade holder (12) is bonded or snapped to the fixing seat (13); The fixing seat (13) is heat-fused, bonded, or snapped onto the balloon (2).

8. The balloon with a blade according to any one of claims 1-4, characterized in that, There are multiple cutting tool assemblies (1), and the multiple cutting tool assemblies (1) are evenly spaced along the circumference of the balloon (2).

9. The balloon with a blade according to claim 8, characterized in that, The mounting base (13) has multiple sets of the tool holders (12) and the blades (11) spaced apart along its length, with each tool holder (12) and blade (11) corresponding to the other.

10. The balloon with a blade according to any one of claims 1-4, characterized in that, The fixing seat (13) extends continuously along the axial direction of the balloon (2), and the length of the fixing seat (13) matches the length of the main body segment of the balloon (2).

Images