Balloon with blade

Abstract

The invention relates to the technical field of medical instruments, and discloses a balloon with a blade, the balloon comprises a cutter assembly and a balloon, the cutter assembly comprises the blade, a cutter holder and a fixing seat which are arranged in the axial direction of the balloon, the blade and the cutter holder are mutually locked through a connecting mechanism, the fixing seat is installed on the outer wall of the balloon, and the fixing seat is arranged on the outer wall of the balloon. The bottom area of the fixing base is larger than that of the tool apron, and the tool apron is installed on the fixing base. Due to the fact that the bottom area of the fixing base is larger than that of the cutter base, the fixing base increases the contact area of the cutter assembly and the balloon, when the balloon passes through a tortuous part in a blood vessel, the balloon is bent, and compared with the prior art, when the cutter assembly bears the same acting force, the stress between the fixing base and the balloon is smaller, and the cutting effect is better. And the stress cracking risk at the joint of the fixed seat and the balloon can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon with a blade. 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 bladed 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 soft plaque and the endothelium within the vessel to a certain degree. This makes the balloon easier to open and the vessel easier to expand, requiring less force and avoiding rupture due to over-expansion. Compared to conventional balloon expansion, a bladed balloon can reduce inflammatory response, elastic recoil, intimal damage, vascular smooth muscle cell proliferation, and potential restenosis risk, while also increasing the area of the vascular lumen. This has the potential to improve technical success rates, increase vascular patency, and achieve better long-term outcomes.

[0004] Existing cutting assemblies for balloons with blades include a blade holder and a cutting blade. The cutting blade is 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 when the cutting blade cuts, the stress between the blade holder and the balloon is high, which can easily cause cracks at the connection between the blade holder and the balloon.

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

[0006] Based on the above, an object of the present invention is to provide a balloon with a blade, in which the stress between the fixing seat and the balloon is smaller, thereby reducing the risk of stress cracking at the junction of the fixing seat and the balloon.

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

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

[0009] As a preferred technical solution for a balloon with a blade, the connecting mechanism includes:

[0010] The blade has a plurality of first slots spaced apart along the length direction, wherein the first slots have openings on one side of the bottom of the blade;

[0011] and

[0012] A first clamping portion provided along the length direction of the knife holder;

[0013] The first clamping portion corresponds to the first clamping slot in a one-to-one manner, and the first clamping portion enters the first clamping slot through the opening.

[0014] As an optimal technical solution for a balloon with a blade, the blade holder is provided with a receiving groove, the first clamping portion is provided in the receiving groove, second clamping grooves are respectively provided at both ends of the receiving groove, second clamping portions are respectively provided at both ends of the blade bottom, and the second clamping portion is clamped in the second clamping groove.

[0015] As an optimal technical solution for a balloon with a blade, the first clamping portion has the same shape as the first clamping groove; the first clamping portion and / or the first clamping groove are waist-shaped, I-shaped, T-shaped or spherical.

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

[0017] As an optimal technical solution for a balloon with a blade, both ends of the blade holder are provided with U-shaped chamfered corners.

[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 bottom of the blade is not greater than Ra3.2.

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

[0021] The fixing seat is hot-melt connected, bonded or clamped to the balloon.

[0022] As a preferred technical solution for a balloon with a blade, there are multiple tool assemblies, and the multiple tool assemblies are evenly spaced along the circumference of the balloon.

[0023] As an optimal technical solution for the balloon with blades, the fixing seat is provided with multiple sets of the blade holders and the blades at intervals along the length direction, and the blade holders and the blades correspond to each other one by one.

[0024] As a preferred technical solution for 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 balloon main body.

[0025] The beneficial effects of the present invention are:

[0026] The present invention provides a balloon with a blade. A fixing seat with a stress dispersion function is provided between the balloon and the blade holder. On the one hand, since the bottom area of the fixing seat is larger than the bottom area of the blade holder, the fixing seat increases the contact area between the blade assembly and the balloon, and the balloon bends when the balloon passes through a tortuous part in the blood vessel; on the other hand, the fixing seat is made of a material with a hardness between that of the balloon and the blade holder, which can play a stress buffering role; compared with the existing technology, when the blade assembly is subjected to the same force, the stress between the fixing seat and the balloon is smaller, thereby 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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.

[0028] Figure 1 1 is a schematic structural diagram 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 structure of the blade and the blade holder provided in a specific embodiment of the present invention;

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

[0032] The following are marked in the figure:

[0033] 1. Tool assembly; 11. Blade; 111. First slot; 1111. Opening; 112. Blade tip; 113. Blade bottom; 114. Second engaging portion; 12. Blade holder; 121. First engaging portion; 122. Rounded corner; 123. Accommodating slot; 124. Second slot; 13. Fixing base;

[0034] 2. Balloon; 21. Balloon wing. DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

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

[0040] Specifically, the tool assembly 1 includes a blade 11, a blade holder 12, and a fixed 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 fixed seat 13 is mounted on the outer wall of the balloon 2. The bottom area of the fixed seat 13 is larger than the bottom area of the blade holder 12, and the blade holder 12 is mounted on the fixed seat 13. The fixed seat 13 is mounted on the outer wall of the balloon 2, and the blade holder 12 is mounted on the fixed seat 13. Since the bottom area of the fixed seat 13 is larger than the bottom area of the blade holder 12, the fixed seat 13 increases the contact area between the tool assembly 1 and the balloon 2. When the balloon 2 passes through a tortuous part in the blood vessel, the balloon 2 bends. Compared with the prior art, when the tool assembly 1 is subjected to the same force, the stress between the fixed seat 13 and the balloon 2 is smaller, which can reduce the risk of stress cracking at the junction of the fixed 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 matches and is almost the same as the length of the main section of the balloon 2 (excluding the conical sections at both ends), so as to increase the contact area between the tool assembly 1 and the balloon 2 as much as possible, maximize the dispersion of the stress between the tool assembly 1 and the balloon 2, and prevent cracking.

[0042] Existing cutting blades lack flexibility and are difficult to navigate through tortuous blood vessels. This can cause damage to the vascular lining or the product, compromising surgical safety and convenience. Furthermore, there is a risk of the cutting blade becoming dislodged within the body, which can seriously threaten the patient's life.

[0043] To solve the above problems, the connecting mechanism includes a blade 11 having a plurality of first card grooves 111 spaced apart along the length direction, and the first card groove 111 having an opening 1111 on one side of the blade bottom 113 of the blade 11. The structure of the first card groove 111 and the opening 1111 can increase the flexibility of the blade 11, and the blade 11 and the balloon 2 can better maintain the consistency of curvature, improve the passing performance of the balloon with the blade in complex and tortuous blood vessels, and reduce the risk of brittle fracture of the blade 11; and the blade holder 12 having a plurality of first clamping parts 121 corresponding to the first card groove 111 along the length direction, the first clamping part 121 enters the first card groove 111 through the opening 1111, thereby fixing the blade 11 on the blade holder 12, and the plurality of first clamping parts 121 simultaneously clamp the first card groove 111. The interlocking connection between the blade 11 and the blade holder 12 can enhance the bonding strength between the blade 11 and the blade holder 12, and reduce the risk of the blade 11 falling off the body.

[0044] In this embodiment, the first engaging portion 121 and / or the first engaging groove 111 are, but are not limited to, waist-shaped, I-shaped, T-shaped, or spherical, all of which can achieve interlocking between the first engaging groove 111 and the first engaging portion 121. Further preferably, the shape of the first engaging portion 121 is the same as that of the first engaging groove 111, thereby preventing the blade 11 from moving relative to the blade holder 12 in the longitudinal direction.

[0045] To more firmly secure blade 11 and distribute stress transferred from blade 11, the material hardness of retainer 13 is preferably between that of blade holder 12 and that of balloon 2. During the cutting and stress-bearing process of blade 11, retainer 13 provides a stress buffer between blade holder 12 and balloon 2, particularly when balloon 2 bends, reducing the risk of stress cracking at the interface between retainer 13 and balloon 2. Furthermore, when balloon 2 negotiates a curve, blade 11 and balloon 2 can better maintain curvature consistency, improving the ability of balloon 2 to pass through.

[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. Further 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 base 113 to the tip 112. The roughness of the tip 112 of the blade 11 is no greater than Ra0.8, ensuring good cutting performance of the tip 112. The roughness of the base 113 of the blade 11 is no greater than Ra3.2, increasing the friction at the junction of the blade 11 and the seat 12 and improving the bonding strength.

[0047] The blade holder 12 has a length between 2.0 and 20.0 mm and a width between 0.1 and 3.0 mm. The material includes, but is not limited to, polyamide, polyethylene, or polyurethane. The blade holder 12 is capable of deforming to a certain extent. When the first engaging portion 121 passes through the opening 1111, it contracts. After the first engaging portion 121 enters the first engaging slot 111, the deformation is restored, allowing the first engaging portion 121 to engage with the first engaging slot 111.

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

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

[0050] In this embodiment, blade 11 is made of UHB AEB-L and has a length of 4.2 mm. It is connected to blade holder 12 via an interlocking structure. Blade holder 12 is made of polyethylene and has a width of 0.2 mm. It is connected to blade holder 12 via an interlocking structure. Blade holder 12 is made of polyamide and is bonded to balloon 2 using light-curing glue. Balloon 2 is a non-compliant balloon made of polyamide.

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

[0052] Further preferably, both ends of the blade holder 12 are provided with U-shaped chamfers 122 , so that the blood flow resistance of the balloon 2 is reduced on the way to the lesion or during the withdrawal process, thereby improving the penetration performance of the balloon 2 .

[0053] Furthermore, the blade holder 12 is provided with a receiving groove 123, the first clamping portion 121 is provided in the receiving groove, and the two ends of the receiving groove 123 are respectively provided with second clamping grooves 124. The wall thickness of the blade 11 gradually becomes thinner from the blade bottom 113 to the blade tip 112, and the two ends of the blade bottom 113 are respectively provided with second clamping portions 114. When the blade 11 is installed in the receiving groove 123, the blade holder 12 can produce a certain deformation so that the first clamping portion 121 can be clamped in the first clamping groove 111, and the second clamping portion 114 can be clamped in the second clamping groove 124, thereby further improving the connection strength between the blade 11 and the blade holder 12 and preventing the blade 11 from moving relative to the blade holder 12.

[0054] Preferably, the blade holder 12 is bonded to or snapped onto the fixing seat 13. When the blade holder 12 is bonded to the fixing seat 13 by adhesive glue, the adhesive glue includes but is not limited to quick-drying glue, light-curing glue, or two-component glue. The fixing seat 13 is hot-melt connected, bonded, or snapped onto the balloon 2. When the fixing seat 13 is hot-melt connected to the balloon 2, the hot-melt connection may be laser welding, ultrasonic welding, or the like. When the fixing seat 13 is bonded to the balloon 2 by adhesive glue, the adhesive glue includes but is not limited to quick-drying glue, light-curing glue, or two-component glue.

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

[0056] Further preferably, there are multiple knife seats 12 and blades 11 on the same tool assembly 1, and they correspond one to one; multiple knife seats 12 are arranged in a straight line and installed on the fixed seat 13 at intervals. When multiple knife seats 12 need to be installed in each row of fixed seats 13, the interlocking structure of the knife seats 12 and the fixed seats 13 can make the knife seats 12 with these pre-installed blades 11 arranged in a straight line. When the balloon 2 is folded, the circumferential knife seats 12 and blades 11 of the balloon 2 are fewer, which is conducive to folding and better protects the blades 11. Furthermore, the gap between adjacent knife seats 12 on each fixed seat 13 is 0.1-2mm. Further preferably, the gap between adjacent knife seats 12 is 0.3-0.6mm, which on the one hand ensures the effective cutting length of the blade 11, and on the other hand improves the flexibility of the balloon 2 through the curve, thereby improving the product passing performance.

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

[0058] 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 balloon with a blade, characterized in that: The invention comprises a tool assembly (1) and a balloon (2), wherein the tool assembly (1) comprises a blade (11), a blade seat (12) and a fixing seat (13) arranged along the axial direction of the balloon (2), the blade (11) and the blade seat (12) are locked with each other through a connecting mechanism, the fixing seat (13) is mounted on the outer wall of the balloon (2), the blade seat (12) is mounted on the fixing seat (13), and the bottom area of the fixing seat (13) is larger than the bottom area of the blade seat (12); The fixing seat (13) extends continuously along the axial direction of the balloon (2), and the fixing seat (13) is provided with a plurality of sets of the knife seats (12) and the blades (11) spaced apart along the length direction, and the knife seats (12) and the blades (11) correspond to each other one by one; The connecting mechanism comprises a plurality of first clamping grooves (111) arranged at intervals along the length direction of the blade (11) and a plurality of first clamping portions (121) arranged along the length direction of the blade seat (12), wherein the first clamping groove (111) is provided with an opening (1111) on one side of the blade bottom (113) of the blade (11), the first clamping portion (121) corresponds to the first clamping groove (111) one by one, the first clamping portion (121) enters the first clamping groove (111) through the opening (1111), the first clamping portion (121) has the same shape as the first clamping groove (111), and the first clamping portion (121) and / or the first clamping groove (111) are waist-shaped, I-shaped, T-shaped or spherical; Both ends of the knife seat (12) are provided with U-shaped chamfers (122), and the knife seat (12) is provided with a receiving groove (123), the first clamping portion (121) is provided in the receiving groove (123), and both ends of the receiving groove (123) are respectively provided with second clamping grooves (124), and both ends of the knife bottom (113) are respectively provided with second clamping portions (114), and the second clamping portion (114) is clamped in the second clamping groove (124).

2. The balloon with a blade according to claim 1, characterized in that: The material hardness of the fixing seat (13) is between the material hardness of the knife seat (12) and the material hardness of the balloon (2).

3. The balloon with a blade according to claim 1, characterized in that: The surface roughness of the blade (11) decreases from the blade base (113) toward the blade tip (112).

4. The balloon with a blade according to claim 3, characterized in that: The roughness of the tip (112) of the blade (11) is not greater than Ra0.8, and the roughness of the bottom (113) of the blade (11) is not greater than Ra3.

2.

5. The balloon with a blade according to claim 1, characterized in that: The knife seat (12) is bonded or clamped to the fixing seat (13).

6. The balloon with a blade according to claim 1, characterized in that: The fixing seat (13) is hot-melt connected, bonded or clamped to the balloon (2).

7. The balloon with a blade according to claim 1, characterized in that: There are multiple cutter assemblies (1), and the multiple cutter assemblies (1) are evenly spaced along the circumference of the balloon (2).

8. The balloon with a blade according to claim 1, 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 section of the balloon (2).

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