A scoring balloon

Abstract

The present application relates to a kind of score balloon, including balloon body;Score part, score part is fixed to the two ends of the outer surface of balloon body, and multiple are evenly distributed along the circumferential direction, score part is the woven tube structure of axially elastic elongation, and the cavity of score part is placed with the hardening component that can freely move.The score part designed in the present application can be axially telescopic when balloon is expanded, has better balloon adhesion and stenosis lesion passability, effectively avoids the displacement, winding and "banana effect" of score part in expansion process;And the mesh structure on woven tube score part can also embed plaque tissue, reach more optimal expansion effect in the process of axial traction.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a scoring balloon. BACKGROUND

[0002] In vascular intervention treatment, balloon dilatation catheter is a commonly used treatment device. However, for calcified, plaque or fibrosis stenosis lesions, ordinary balloon catheters cannot effectively dilate the stenosis lesion site and are prone to flow-limiting dissection, so pressure focusing balloon is needed. Common pressure focusing balloons include blade cutting balloon and guide wire scoring balloon.

[0003] The blade cutting balloon can regularly cut the lesion at a lower expansion pressure, but due to the overall bonding design of the blade and the balloon, the overall bending performance of the balloon is poor, and the sharp blade is easy to excessively cut the inner wall of the blood vessel.

[0004] The guide wire scoring balloon is generally divided into single guide wire scoring balloon, double guide wire scoring balloon and multiple guide wire scoring balloon. The cross section of the guide wire can be circular, square or triangular. The cutting effect of the circular wire is limited, and the contact area of the square or triangular scoring member with the blood vessel wall is smaller than that of the circular guide wire, so the expansion force of the scoring member on the blood vessel wall is also greater. Compared with the blade cutting balloon, the guide wire scoring balloon can reduce the risk of damage to the blood vessel wall, and it also has better bending performance and is easier to pass through the tortuous blood vessel to reach the lesion, but the guide wire scoring balloon is prone to displacement, entanglement and "banana effect" after expansion. SUMMARY

[0005] The purpose of the present application is to provide a scoring balloon for interventional treatment of vascular calcified plaque, which can effectively avoid displacement, entanglement and "banana effect" of the scoring member during expansion.

[0006] To achieve the above purpose, the present application provides the following technical scheme:

[0007] The scoring balloon comprises a tip, an inner tube, a guide wire, a balloon body and a scoring member. The balloon body is further provided with a balloon folding wing for unfolding. The balloon body is a hollow tubular structure, and the inner tube is arranged axially in the balloon body. The tip end of the inner tube is fixedly connected to the tip, and the tail end of the inner tube passes through the balloon body. The guide wire and the development ring are arranged in the inner tube. The guide wire penetrates through the inner tube and the tip. The tail end of the balloon body is connected to a catheter assembly, and the catheter assembly is sleeved on the outer part of the inner tube with a gap. The scoring member is arranged between the balloon body and the balloon folding wing. The scoring member comprises braided wires, and the scoring member is a tubular structure that can be axially elastically elongated by braiding four or more braided wires uniformly in the circumferential direction. The scoring member is wrapped around the outer surface of the balloon body, and the two ends of the scoring member are fixed to the two ends of the corresponding outer surface of the balloon body.

[0008] In the above-mentioned scoring balloon, the inner cavity of the scoring member is further provided with a freely movable hardening component; the hardening component is a solid wire made of stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the cross section of the hardening component is one or more of a circle, a triangle and a square; the length of the wire is shorter than the initial length of the braided wire, and at least one end is not fixed.

[0009] In the above-mentioned scoring balloon, the cross section of the scoring member is one or more of a circle, a triangle and a square.

[0010] In the above-mentioned scoring balloon, the cross section of the two ends of the scoring member is the same as or larger than the cross section of the middle part; the elongation of the scoring member in the axial direction is 100%-200%.

[0011] In the above-mentioned scoring balloon, the braided tube of the scoring member is braided by more than four braided wires.

[0012] In the above-mentioned scoring balloon, the material of the braided wire is stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the wire diameter of the braided wire is 0.02-0.3mm.

[0013] In the above-mentioned scoring balloon, the tip, the inner tube and the scoring member are fixed by welding, bonding or mechanical connection.

[0014] In the above-mentioned scoring balloon, the cross section of the scoring member is 0.2mm-1.0mm, and the braided mesh number is 20-200.

[0015] The present application has the following advantages:

[0016] The scoring member of the present application can axially stretch and contract during balloon expansion, has good balloon adhesion and stenosis lesion passability, effectively avoids the displacement, winding and "banana effect" of the scoring member during expansion, and the mesh structure on the braided tube scoring member can also embed plaque tissue, achieving better splitting effect during axial traction. BRIEF DESCRIPTION OF DRAWINGS

[0017] Fig. 1 The figure is a schematic diagram of the structure of the present application;

[0018] Fig. 2 The figure is a schematic diagram of the structure of the scoring member braided by four braided wires in the present application;

[0019] Fig. 3 The figure is a schematic diagram of the cross section of the scoring balloon of the present application in the folded state.

[0020] In the figure, 1 is a tip; 2 is an inner tube; 3 is a guide wire; 4 is a balloon body; 5 is a scoring member; 6 is a developing ring; 7 is a catheter assembly; 8 is a balloon folding wing; 9 is a braided wire; and 10 is a hardening component. DETAILED DESCRIPTION

[0021] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the drawings. It should be understood that the specific embodiments described herein are merely intended to explain the present application and not to limit the present application.

[0022] Referring to Figs. 1 to 3 The present application relates to a scoring balloon, comprising a tip 1, an inner tube 2, a guide wire 3, a balloon body 4 and a scoring member 5; the balloon body 4 is further provided with a balloon folding wing 8 for deployment; the balloon body 4 is a hollow tubular structure, and the inner tube 2 is axially arranged in the balloon body 4; the tip 1 is fixedly connected to the top end of the inner tube 2, and the tail end of the inner tube 2 penetrates through the balloon body 4; the guide wire 3 and a developing ring 6 are arranged in the inner tube 2, and the guide wire 3 penetrates through the inner tube 2 and the tip 1; the balloon body 4 is communicated with a catheter assembly 7 at the tail end, and the catheter assembly 7 is gap-set on the outer part of the inner tube 2; the scoring member 5 is further arranged between the balloon body 4 and the balloon folding wing 8; the scoring member 5 comprises braided wires 9, and the scoring member 5 is a tubular structure which is axially elastically extendable and is uniformly distributed and braided by four or more braided wires 9 in the circumferential direction, and the scoring member 5 is wrapped around the outer surface of the balloon body 4; the scoring member 5 is fixed at both ends to the corresponding two ends of the outer surface of the balloon body 4.

[0023] A hardening component 10 is further arranged in the inner cavity of the scoring member 5 and is freely movable; the material of the hardening component 10 is a solid structure of wire such as stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the cross section of the wire of the hardening component 10 is one or more of a circle, a triangle and a square; the length of the wire is shorter than the initial length of the braided wire 9, and at least one end is not fixed. The hardening component 10 plays a role in improving the hardness of the scoring member 5, and the scoring member 5 with improved hardness can have a stronger breaking effect on calcified plaques.

[0024] As shown in Fig. 1 one end of the scoring member 5 is fixedly connected to the inner tube 2 and the tip 1, and the other end is fixedly connected to the catheter assembly 7. The fixed method is well known to those skilled in the art and is not particularly limited, and in the present application, welding, adhesion or mechanical connection is preferred.

[0025] As shown in Fig. 2 the scoring member 5 is braided by four braided wires. The diameter of the scoring member 5 is preferably 0.2-1.0 mm, and the braiding count is preferably 20-200. The two ends or one end of the scoring member can be a variable-diameter structure to reduce the profile size of the welding position. The scoring member can be axially stretched and retracted, and the axial elongation rate is preferably 100%-200%, and when stretched and retracted in the axial direction, the width of the cross section changes by 0.1-0.5 mm, and the height changes by 0.1-0.5 mm.

[0026] The cross section of the braided wire can be one or more of circular, square or wedge-shaped, and the material can be a medical grade material known to those skilled in the art, such as stainless steel, nickel-titanium alloy or cobalt-chromium alloy, etc.; the wire diameter of the braided wire is preferably 0.02-0.3 mm.

[0027] As shown in Fig. 3 The score members 5 are evenly distributed in the balloon body 4 and wrapped in the balloon folding wings in the axial direction to avoid damaging the blood vessel wall during delivery. When the balloon is inflated, the score members contact the stenosis lesion, which can not only uniformly expand the lesion in the radial direction, but also axially pull the plaque tissue to achieve a better expansion effect. Meanwhile, the stretchable score members can easily avoid displacement and winding of the score members during expansion, and can also prevent the "banana effect". In addition, the mesh tube structure also increases the contact area between the balloon body and the blood vessel wall, reducing the possibility of balloon displacement. The above is only a preferred specific embodiment of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can make equivalent replacements or changes within the technical range disclosed by the present application according to the technical solution and inventive concept of the present application, which should be covered within the protection scope of the present application.

Claims

1. A scoring balloon, characterized by, The application relates to a balloon catheter, which comprises a tip (1), an inner tube (2), a guide wire (3), a balloon body (4) and a scoring element (5). The balloon body (4) is further provided with balloon folding wings (8) for unfolding. The balloon body (4) is a hollow tubular structure, and the inner tube (2) is arranged axially in the balloon body (4). The tip (1) is fixedly connected to the top end of the inner tube (2), and the tail end of the inner tube (2) penetrates through the balloon body (4). The guide wire (3) and a developing ring (6) are arranged in the inner tube (2), and the guide wire (3) penetrates through the inner tube (2) and the tip (1). The tail end of the balloon body (4) is communicated with a catheter assembly (7), and the catheter assembly (7) is arranged outside the inner tube (2) in a sleeved mode with a gap. The scoring element (5) is arranged between the balloon body (4) and the balloon folding wings (8). The scoring element (5) comprises braided wires (9), and the scoring element (5) is a tubular structure which is uniformly distributed and braided in a circumferential direction by four or more braided wires (9) and can be axially elastically elongated. The scoring element (5) is arranged around the outer surface of the balloon body (4), and the two ends of the scoring element (5) are fixed to the two ends of the outer surface of the balloon body (4). A hardening component (10) is further arranged in the inner cavity of the scoring element (5) and can freely move. The hardening component (10) is a solid wire made of stainless steel, nickel-titanium alloy or cobalt-chromium alloy. The cross section of the hardening component (10) is one or more of a circle, a triangle and a square. The length of the wire is shorter than the initial length of the braided wire (9), and at least one end is not fixed. The cross section sizes of the two ends and the middle of the scoring element (5) are the same or the cross section size of the middle is larger than that of the two ends. The elongation rate of the scoring element in the axial direction is 100%-200%. The braided tube of the scoring element (5) is braided by four or more braided wires (9).

2. The scoring balloon of claim 1, wherein: The cross section of the scoring element (5) is one or more of a circle, a triangle and a square.

3. The scoring balloon of claim 1, wherein: The material of the braided wire (9) is stainless steel, nickel-titanium alloy or cobalt-chromium alloy. The wire diameter of the braided wire (9) is 0.02-0.3 mm.

4. The scoring balloon of claim 1, wherein, The scoring element (5) and the tip (1) and the inner tube (2) and the catheter assembly (7) are fixed by welding, bonding or mechanical connection.

5. The scoring balloon of claim 1, wherein: The cross section size of the scoring element (5) is 0.2-1.0 mm, and the braiding mesh number is 20-200.

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