Nicking balloon

Abstract

The invention relates to a nicked balloon. The nicked balloon comprises a balloon body, the nicking pieces are fixed to the two ends of the outer surface of the balloon body and evenly distributed in the circumferential direction, the nicking pieces are of braided tube structures capable of axially and elastically extending, and hardening parts capable of freely moving are arranged in inner cavities of the nicking pieces. The nick piece designed by the invention can axially stretch out and draw back when the balloon is expanded, has better balloon adherence and stenosis lesion trafficability, and effectively avoids displacement, winding and'banana effect 'of the nick piece in the expansion process; and the mesh structure on the braided tube nick piece can be embedded into plaque tissues, so that a better expansion effect is achieved in the axial traction process.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a scored balloon. Background Art

[0002] In vascular interventional treatment, balloon dilatation catheter is a commonly used treatment device. However, for stenotic lesions such as calcification, plaque or fibrosis, ordinary balloon catheters cannot effectively dilate the stenotic lesions and are prone to flow-limiting dissections, so pressure-focused balloons are needed. Common pressure-focused balloons include blade-cutting balloons and guidewire-scored balloons.

[0003] The blade-cutting balloon can regularly cut lesions 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 very poor, and the sharp blade is prone to excessively cutting the inner wall of the blood vessel.

[0004] Guidewire scored balloons are generally divided into single-guidewire scored balloons, double-guidewire scored balloons and multi-guidewire scored balloons. The cross-section of the guidewire can be round, square or triangular. Usually, the cutting effect of round wires is limited. The contact area between the square or triangular scoring piece and the blood vessel wall is smaller than that of round guidewires, so its expansion force on the blood vessel wall is also greater. Compared with blade cutting balloons, guidewire scored balloons can reduce the risk of damage to the blood vessel wall. In addition, they also have better bendability and are easier to reach lesions through tortuous blood vessels. However, after the expansion of the guidewire scored balloon, the scoring piece is prone to displacement, entanglement and "banana effect". Summary of the invention

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

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] The scored balloon comprises a tip, an inner tube, a guide wire, a balloon body and a scoring piece; the balloon body is also provided with balloon folding wings for unfolding; the balloon body is a hollow tubular structure, and the inner tube is axially arranged inside the balloon body; the top end of the inner tube is fixedly connected to the tip, and the tail end of the inner tube passes through the balloon body; a guide wire and a developing ring are arranged inside the inner tube, and the guide wire passes 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 outside of the inner tube with a gap; a scoring piece is also arranged between the balloon body and the balloon folding wings; the scoring piece comprises braided wires, and the scoring piece is a tube structure that can be axially elastically stretched and is braided by more than four braided wires evenly distributed in the circumferential direction, and the scoring piece surrounds the outer surface of the balloon body; the two ends of the scoring piece are fixed to the two ends of the corresponding outer surface of the balloon body.

[0008] In the above-mentioned scored balloon, the inner cavity of the scored part is also provided with a freely movable hardened component; the hardened component is a solid wire of stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the cross-section of the hardened component is one or more of circular, triangular, and square wires; the wire is shorter in length than the initial length of the braided wire, and at least one end is not fixed.

[0009] In the above-mentioned scored balloon, the cross section of the scored member is one or more of circular, triangular, and square;

[0010] In the above-mentioned scored balloon, the cross-sectional dimensions of the two ends of the scored piece are the same as those of the middle, or the cross-sectional dimension of the middle is larger than those of the two ends; and the elongation of the scored piece in the axial direction is 100%-200%.

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

[0012] In the above-mentioned scored 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 0.02-0.3 mm.

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

[0014] In the above-mentioned scored balloon, the cross-sectional size of the scored piece is 0.2mm-1.0mm, and the weaving mesh number is 20-200 meshes.

[0015] The beneficial effects of the present invention are:

[0016] The scoring member of the present invention can be axially expanded and retracted during balloon expansion, has good balloon wall adhesion and stenosis lesion permeability, and effectively avoids displacement, entanglement and "banana effect" of the scoring member during expansion; moreover, the mesh structure on the braided tube scoring member can also be embedded in plaque tissue, achieving a better expansion effect during axial traction. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the structural principle of the present invention;

[0018] Figure 2 It is a schematic diagram of the structure of the notched piece woven by four braiding wires in the present invention;

[0019] Figure 3 It is a schematic cross-sectional view of the scored balloon of the present invention in a folded state.

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

[0021] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0022] refer to Figures 1 to 3 The present invention relates to a scoring balloon, comprising a tip 1, an inner tube 2, a guide guide wire 3, a balloon body 4 and a scoring piece 5; the balloon body 4 is also provided with a balloon folding wing 8 for unfolding; the balloon body 4 is a hollow tubular structure, and the inner tube 2 is axially arranged inside the balloon body 4; the top end of the inner tube 2 is fixedly connected to the tip 1, and the tail end of the inner tube 2 passes through the balloon body 4; a guide guide wire 3 and a developing ring 6 are arranged in the inner tube 2, and the guide guide wire 3 passes through the inner tube 2 and the tip 1; the tail end of the balloon body 4 is connected to a catheter assembly 7, and the catheter assembly 7 is sleeved on the outside of the inner tube 2 with a gap; a scoring piece 5 is also arranged between the balloon body 4 and the balloon folding wing 8; the scoring piece 5 includes a braided wire 9, and the scoring piece 5 is a tube structure that can be axially elastically extended and is evenly distributed and woven along the circumferential direction by more than four braided wires 9, and the scoring piece 5 surrounds the outer surface of the balloon body 4; the two ends of the scoring piece 5 are fixed to the two ends of the corresponding outer surface of the balloon body 4.

[0023] The inner cavity of the scoring member 5 is also provided with a freely movable hardening component 10; the material of the hardening component 10 is a solid wire structure 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 circular, triangular and square wires; the wire is shorter than the initial length of the braided wire 9 in the length direction, and at least one end is not fixed. The hardening component 10 serves to increase the hardness of the scoring member 5, and the scoring member 5 can have a stronger rupture effect on the calcified plaque after the hardness is increased.

[0024] like Figure 1 As shown, one end of the notch member 5 is connected and fixed to the inner tube 2 and the tip 1, and the other end is connected and fixed to the catheter assembly 7. The fixing method is a method well known to those skilled in the art, and there is no particular limitation. In the present invention, welding, bonding or mechanical connection is preferred.

[0025] like Figure 2 As shown, the scoring member 5 is woven from 4 braided wires. The diameter of the scoring member 5 is preferably 0.2-1.0 mm, and the number of braided wires is preferably 20-200 meshes. Both ends or one end of the scoring member can be a variable diameter structure to reduce the profile size of the welding point. The scoring member can be axially retracted, and the axial elongation is preferably 100%-200%. When it is retracted along the axial direction, the width of its cross section changes to 0.1-0.5 mm, and the height changes to 0.1-0.5 mm.

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

[0027] like Figure 3 As shown, the notched parts 5 are evenly distributed axially on the balloon body 4 and wrapped in the folding wings of the balloon to avoid damaging the blood vessel wall during transportation. When the balloon is filled, the notched parts contact the stenotic lesions. In addition to radially and evenly expanding the lesions, they can also axially pull the plaque tissue to achieve a better expansion effect. At the same time, the retractable notched parts can easily avoid displacement and entanglement of the notched parts 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 invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field within the technical scope disclosed by the present invention, according to the technical solution and its inventive concept of the present invention, make equivalent replacement or change, should be covered within the protection scope of the present invention.

Claims

1. A scored balloon, characterized in that: The invention comprises a tip (1), an inner tube (2), a guide wire (3), a balloon body (4) and a notching member (5); the balloon body (4) is also provided with balloon folding wings (8) for unfolding; the balloon body (4) is a hollow tubular structure, and the inner tube (2) is axially arranged inside the balloon body (4); the top end of the inner tube (2) is fixedly connected to the tip (1), and the tail end of the inner tube (2) passes through the balloon body (4); a guide wire (3) and a developing ring (6) are arranged inside the inner tube (2), and the guide wire (3) passes through the inner tube (2) and the tip (1); the balloon The tail end of the body (4) is connected to a catheter assembly (7), and the catheter assembly (7) is sleeved on the outside of the inner tube (2) with a gap; a notched piece (5) is also arranged between the balloon body (4) and the balloon folding wing (8); the notched piece (5) includes a braided wire (9), and the notched piece (5) is a tube structure that can be axially elastically stretched and is evenly distributed and braided by more than four braided wires (9) along the circumferential direction; the notched piece (5) surrounds the outer surface of the balloon body (4); and the two ends of the notched piece (5) are fixed to the two ends of the outer surface of the corresponding balloon body (4).

2. The scored balloon according to claim 1, characterized in that: The inner cavity of the notching member (5) is also provided with a freely movable hardening component (10); the hardening component (10) is a solid wire of stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the cross-section of the hardening component (10) is one or more of a circular, triangular or square wire; the wire is shorter in length than the initial length of the braided wire (9), and at least one end is not fixed.

3. The scored balloon according to claim 1, characterized in that: The cross section of the notched member (5) is one or more of circular, triangular, and square.

4. The scored balloon according to claim 1, characterized in that: The cross-sectional dimensions of the two ends of the notched piece (5) are the same as those of the middle, or the cross-sectional dimensions of the middle are larger than those of the two ends; and the elongation of the notched piece in the axial direction is 100%-200%.

5. The scored balloon according to claim 1, characterized in that: The notched member (5) braided tube is braided from more than four braided wires (9).

6. The scored balloon according to claim 1, characterized in that: 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.

7. The scored balloon according to claim 1, characterized in that: The notched member (5) and the tip (1), the inner tube (2), and the notched member (5) and the catheter assembly (7) are all fixed by welding, bonding or mechanical connection.

8. The scored balloon according to claim 1, characterized in that: The cross-sectional size of the notched member (5) is 0.2 mm to 1.0 mm, and the weaving mesh number is 20 to 200 meshes.

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