Balloon dilatation catheter

Abstract

The balloon dilatation catheter comprises a tip end, an inner tube, a balloon and an outer tube, the tip end and the inner tube are sequentially connected from the far end to the near end, the tip end and the inner tube are each of a hollow structure and communicate with each other to form a communicating channel, and the tip end is of a multi-layer structure; the balloon and the outer tube are sequentially arranged on the periphery of the inner tube in a sleeving mode from the far end to the near end, and a conveying channel communicated with the balloon is formed between the outer tube and the inner tube. The tip design of the balloon dilatation catheter is convenient for entering a blood vessel, in addition, the catheter is of a multi-layer structure, the hardness of the tip can be reduced through the multi-layer design, and the damage to the blood vessel wall is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a balloon dilatation catheter. Background Art

[0002] Currently, in the field of intravascular treatment and peripheral vascular disease treatment, peripheral balloon dilatation catheter technology aims to solve the problem of vascular stenosis or occlusion, restore blood flow through minimally invasive interventional means, reduce surgical trauma, reduce the risk of vascular re-stenosis after treatment, and improve the accuracy, safety and long-term effects of treatment.

[0003] Traditional peripheral angioplasty balloon catheters have certain limitations in the treatment of peripheral arterial disease, including the risk of vascular damage, resulting in poor treatment effects.

[0004] There is an urgent need to improve the balloon dilatation catheter to ensure the effectiveness of the balloon dilatation catheter. Summary of the invention

[0005] The present application mainly provides a balloon dilatation catheter, which can have a good use effect when used.

[0006] In order to solve the above technical problems, the technical solution adopted in the present application is: to provide a balloon dilatation catheter, which includes a tip and an inner tube, a balloon and an outer tube, wherein the tip and the inner tube are connected in sequence from the distal end to the proximal end, and the tip and the inner tube are both hollow structures and are interconnected to form a conduction channel, wherein the tip is a multi-layer structure; the balloon and the outer tube are sequentially arranged on the periphery of the inner tube from the distal end to the proximal end, and a delivery channel connected to the balloon is formed between the outer tube and the inner tube.

[0007] Among them, the tip includes an inner layer, a middle layer and an outer layer arranged in sequence from the inside to the outside, the material of the inner layer includes a block polyetheramide resin material; the material of the middle layer includes a low-density polyethylene material; the material of the outer layer includes a high-density polyethylene material.

[0008] Wherein, the length of the tip ranges from 2 to 10 mm.

[0009] Wherein, the distal end of the balloon is connected to the tip, and the material of the balloon includes silica gel.

[0010] The balloon comprises a head, a middle section and a tail section which are sequentially connected from the distal end to the proximal end, and the middle section is cylindrical after expansion; the length of the middle section is 20-100 mm.

[0011] Wherein, the inner tube is provided with a development mark, and the development mark is located inside the balloon; wherein, the material of the development mark includes platinum-iridium alloy.

[0012] Wherein, the length of the inner tube ranges from 90 to 150 mm.

[0013] Wherein, a hydrophilic material is coated in a preset area on the outer circumference of the outer tube, wherein the hydrophilic material includes polyvinyl pyrrolidone; and in the extension direction of the outer tube, the length range of the preset area is 33-37 cm.

[0014] In which, the balloon dilatation catheter also includes a stress diffusion tube and a connecting seat, wherein the stress diffusion tube is arranged as a hollow structure, the tip, the inner tube and the stress diffusion tube are connected in sequence from the distal end to the proximal end, and the stress diffusion tube is also connected to the outer tube, and the stress diffusion tube is provided with a first channel connected to the conduction channel and a second channel connected to the delivery channel; the connecting seat is connected to the stress diffusion tube, including a first branch tube connected to the first channel and a second branch tube connected to the second channel.

[0015] Wherein, a one-way valve is provided in the second branch pipe for controlling the opening and closing of the second channel.

[0016] The beneficial effects of the present application are as follows: in the balloon dilatation catheter of the present application, the tip design facilitates entry into the blood vessel, and the catheter is a multi-layer structure, and the multi-layer design can reduce the hardness of the tip and reduce damage to the blood vessel wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. Among them:

[0018] Figure 1 This is a schematic structural diagram of an embodiment of a balloon dilatation catheter in the present application;

[0019] Figure 2 for Figure 1 Enlarged schematic diagram of area A of the middle balloon dilatation catheter;

[0020] Figure 3 for Figure 1 A schematic diagram of the cross-sectional structure of a mid-tip embodiment.

[0021] Explanation of the reference numerals in the figures: 100 balloon dilatation catheter; 10 tip; 11 inner layer; 12 middle layer; 13 outer layer; 20 inner tube; 21 development mark; 22 conducting channel; 30 outer tube; 31 delivery channel; 32 hydrophilic material; 40 balloon; 41 head; 42 middle part; 43 tail; 50 stress diffusion tube; 60 connecting seat; 61 first branch tube; 62 second branch tube; L1 length of the middle part; L2 length of the inner tube; L3 length of the preset area; L4 length of the tip; D diameter of the balloon; Ф1 outer diameter of the outer tube; Ф2 outer diameter of the inner tube. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by technicians in the technical field to which this application belongs; the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" in the specification and claims of this application and the above-mentioned figure descriptions and any variations thereof are intended to cover non-exclusive inclusions.

[0024] In the description of the embodiments of the present application, the technical terms "first", "second", etc. are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. In the description of the embodiments of the present application, the meaning of "multiple" is more than two, unless otherwise clearly and specifically defined.

[0025] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0026] In the description of the embodiments of the present application, unless otherwise clearly specified and limited, technical terms such as "installed", "connected", "connected", "fixed" and the like 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, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0027] See also Figure 1 and Figure 2 The present application provides a balloon dilatation catheter 100, which includes a tip 10 and an inner tube 20, a balloon 40 and an outer tube 30, wherein the tip 10 and the inner tube 20 are sequentially connected from the distal end to the proximal end, the tip 10 and the inner tube 20 are both hollow structures, and are interconnected to form a conducting channel 22, wherein the tip 10 is a multi-layer structure; the balloon 40 and the outer tube 30 are sequentially sleeved on the periphery of the inner tube 20 from the distal end to the proximal end, and a delivery channel 31 connected to the balloon 40 is formed between the outer tube 30 and the inner tube 20.

[0028] Specifically, from the distal end to the proximal end, the tip 10 and the inner tube 20 are arranged in sequence, and both are hollow designs, so that a conducting channel 22 is formed between the two, which is convenient for transmitting medium or for a guide wire to pass through. The design of the tip 10 facilitates the balloon dilatation catheter 100 to enter the blood vessel. In addition, the tip 10 is a multi-layer structure, and the multi-layer design can reduce the hardness of the tip 10 and reduce damage to the blood vessel wall. At the same time, the outer surface of the inner tube 20 is sheathed with a balloon 40 and an outer tube 30, and the balloon 40 and the outer tube 30 are connected. The outer tube 30 can transmit or extract the medium to the balloon 40 to make the balloon 40 expand or contract. The outer tube 30 is sheathed on the outside of the inner tube 20, so that a delivery channel 31 is formed between the two, which is convenient for transmitting the medium into the balloon 40.

[0029] See also Figure 3The tip 10 includes an inner layer 11, an intermediate layer 12 and an outer layer 13 which are arranged in sequence from the inside to the outside. The material of the outer layer 13 includes a block polyetheramide resin material; the material of the intermediate layer 12 includes a low-density polyethylene material; and the material of the inner layer 11 includes a high-density polyethylene material. Among them, the block polyetheramide resin (PEBAX) of the material of the outer layer 13 has many excellent properties between thermoplastic elastomers and rubber bodies, and is easy to process, so it is suitable for the balloon dilatation catheter 100 in this application. At the same time, the PEBAX material is elastic, and after the balloon dilatation catheter 100 enters the blood vessel, it can avoid damage to the inner wall of the blood vessel. The material of the intermediate layer 12 includes a low-density polyethylene material, which has good softness and high impact resistance, and meets the functional requirements of the tip 10. The material of the inner layer 11 includes a high-density polyethylene material, which has good mechanical strength and is conducive to maintaining structural stability.

[0030] Please continue reading Figure 2 , the length L4 of the tip ranges from 2 to 10 mm. Specifically, the length L4 of the tip can be 2, 3, 4, 5, 6, 7, 8, 9 or 10 mm, and the length design is diverse to meet the needs of various usage scenarios.

[0031] Please continue reading Figure 1 and Figure 2 The distal end of the balloon 40 is connected to the tip 10, and the material of the balloon 40 includes silicone. Specifically, the distal end of the balloon 40 is directly connected to the tip 10 and is sleeved on the outside of the inner tube 20, so that the overall structure is compact and the balloon 40 is convenient for supporting the blood vessel area that needs to be expanded. In addition, the silicone material has good stability and can expand, which meets the use requirements of the balloon 40.

[0032] Please continue reading Figure 2 The balloon 40 includes a head 41, a middle part 42 and a tail 43 connected in sequence from the distal end to the proximal end, and the middle part 42 is cylindrical after expansion. Specifically, the cylindrical design of the middle part 42 after expansion can increase the contact area between the balloon 40 and the blood vessel. At the same time, the middle part 42 fits the inner wall of the blood vessel after expansion, and is a semi-compliant balloon. This design helps to more accurately control the expansion of the balloon 40 and reduce the risk of restenosis of the blood vessel.

[0033] Continue reading Figure 1 and Figure 2In one embodiment, the diameter D of the balloon 40 is 2-10 mm. Specifically, the diameter D of the balloon 40 can be 2, 3, 4, 5, 6, 7, 8, 9 or 10 mm. The diameter D of the balloon 40 determines the size of the balloon 40 after expansion. A variety of diameter size selections can meet the needs of a variety of usage scenarios. In addition, when the diameter D of the balloon 40 is 10 mm, in actual use, the expansion amplitude of the balloon 40 can be controlled, for example, the diameter of the balloon 40 after expansion is maintained at 8 mm.

[0034] Please continue reading Figure 1 and Figure 2 The length L1 of the middle portion 42 is 20-100 mm. Specifically, the length L1 of the middle portion 42 can be 20, 30, 40, 50, 60, 70, 80, 90 or 100 mm. The balloon 40 of a suitable length is selected according to the actual situation such as the length of the stenosis section in the blood vessel.

[0035] Please continue reading Figure 1 and Figure 2 The inner tube 20 is provided with a developing mark 21, and the developing mark 21 is located inside the balloon 40; at least two developing marks 21 are provided inside the balloon 40, so that the position of the balloon 40 can be detected by the radiation. The number of developing marks 21 can be 2, 3 or more.

[0036] The material of the development mark 21 includes a platinum-iridium alloy. The biocompatibility and corrosion resistance of the platinum-iridium alloy facilitate the production of the development mark 21 and have a good service life. Meanwhile, X-rays cannot pass through the platinum-iridium alloy, so the development mark 21 has a development function.

[0037] Please continue reading Figure 1 and Figure 2 The length L2 of the inner tube 20 is in the range of 90-150 mm; specifically, the length L2 of the inner tube 20 can be 90, 100, 110, 120, 130, 140 or 150 mm. The inner tube 20 is disposed inside the outer tube 30, and a standard guide wire can be inserted to facilitate the balloon dilatation catheter 100 to enter the lesion site.

[0038] In one embodiment, the inner diameter of the inner tube 20 is 2.1-2.3 mm; specifically, the inner diameter of the inner tube 20 may be 2.1, 2.2 or 2.3 mm.

[0039] Please continue reading Figure 1 and Figure 2 , the outer diameter Φ2 of the inner tube 20 is 2.3-2.5 mm. Specifically, the outer diameter Φ2 of the inner tube 20 can be 2.3, 2.4 or 2.5 mm. At the same time, the outer diameter Φ2 of the inner tube 20 is greater than the inner diameter of the inner tube 20.

[0040] In one embodiment, the inner diameter of the outer tube 30 is 2.5-2.7 mm; specifically, the inner diameter of the outer tube 30 may be 2.5, 2.6 or 2.7 mm.

[0041] Please continue reading Figure 1 and Figure 2 , the outer diameter Φ1 of the outer tube 30 is 2.7-3.0 mm. Specifically, the outer diameter Φ1 of the outer tube 30 can be 2.7, 2.8, 2.9 or 3.0 mm. Meanwhile, the outer diameter Φ1 of the outer tube 30 is larger than the inner diameter of the outer tube 30 .

[0042] Please continue reading Figure 1 and Figure 2 , a hydrophilic material 32 is coated in a preset area on the outer circumferential surface of the outer tube 30, wherein the hydrophilic material 32 includes polyvinyl pyrrolidone (PVP); and in the extension direction of the outer tube 30, the length L3 of the preset area ranges from 33 to 37 cm. Specifically, the hydrophilic material 32 is coated by dipping, which plays a lubricating role, reduces the push resistance, and facilitates the balloon dilatation catheter 100 to enter the designated area of ​​the target blood vessel. Among them, the length L3 of the preset area can be 33, 34, 35, 36 or 37 cm.

[0043] Please continue reading Figure 1 The balloon dilatation catheter 100 also includes a stress diffusion tube 50 and a connection seat 60, wherein the stress diffusion tube 50 is set as a hollow structure, the tip 10, the inner tube 20 and the stress diffusion tube 50 are sequentially connected from the distal end to the proximal end, and the stress diffusion tube 50 is also connected to the outer tube 30, and the stress diffusion tube 50 is provided with a first channel connected to the conduction channel 22 and a second channel connected to the delivery channel 31; the connection seat 60 is connected to the stress diffusion tube 50, including a first branch tube 61 connected to the first channel and a second branch tube 62 connected to the second channel. Specifically, the stress diffusion tube 50 connects the inner tube 20 and the outer tube 30 to the connection seat 60, and correspondingly, the stress diffusion tube 50 is a hollow structure, the tip 10, the inner tube 20, the stress diffusion tube 50 and the connection seat 60 are sequentially connected from the distal end to the proximal end, and form a conduction channel 22 and a delivery channel 31. Among them, the conduction channel 22 is connected to the first channel of the stress diffusion tube 50, and the delivery channel 31 is connected to the second channel of the stress diffusion tube 50. The first branch tube 61 in the connection seat 60 is connected to the first channel of the stress diffusion tube 50 for drainage or transmission of medium, and the second branch tube 62 in the connection seat 60 is connected to the second channel of the stress diffusion tube 50 for communication with the balloon 40 .

[0044] In one embodiment, the material of the stress diffusion tube 50 includes polyether block polyamide (PEBAX); specifically, the PEBAX material has the properties of a thermoplastic elastomer, has good rebound and elastic recovery, and precise dimensional stability; and excellent processing performance facilitates the processing and use of the stress diffusion tube 50. At this time, the stress diffusion tube 50 and the connecting seat 60 are arranged at the proximal end of the catheter, and the stress diffusion tube 50 is used to prevent the outer tube 30 from bending.

[0045] In one embodiment, a one-way valve (not shown) is provided in the second branch pipe 62 to control the opening and closing of the second channel. Specifically, the one-way valve can control the opening and closing of the delivery channel 31 in the outer tube 30. When the one-way valve controls the outer tube 30 to be opened, the one-way valve can deliver fluid or gas to the balloon 40 through the outer tube 30 to fill the balloon 40, or the one-way valve can guide the fluid or gas in the balloon 40 through the outer tube 30 to reduce the filled balloon 40. When the one-way valve controls the outer tube 30 to be closed, the one-way valve stops conveying or guiding fluid or gas to the balloon 40 through the outer tube 30, so that the balloon 40 remains in its original state.

[0046] The method of using the balloon dilatation catheter 100 in the present application is as follows:

[0047] (1) At the beginning of the procedure, the doctor uses standard techniques (such as the Seldinger technique) to percutaneously introduce the catheter sheath into the blood vessel, that is, puncture the blood vessel, and then push the catheter sheath into the blood vessel along the guide wire and fix it in place;

[0048] (2) When using the catheter sheath, the doctor injects heparinized saline into the catheter sheath through the hemostatic valve to keep the blood vessel channel open and reduce the risk of thrombosis. The hemostatic valve can also be closed when the catheter sheath is not in use to prevent blood from flowing out;

[0049] (3) Under fluoroscopy, the guidewire is advanced and passed through the lesion;

[0050] (4) inserting the distal end of the balloon dilatation catheter 100 from the proximal end of the guide wire;

[0051] (5) The balloon dilatation catheter 100 is introduced into the stenosis along the guidewire and continued to be advanced under fluoroscopic monitoring, and the usable (expanded) portion of the balloon 40 is positioned in the stenosis using a radiopaque marker;

[0052] (6) After the marker band is correctly positioned, the balloon 40 is inflated, and the expansion balloon 40 is gradually expanded to expand the lesion to the diameter calculated in the compliance table, and the pressure is maintained for a period of time to expand the target area;

[0053] (7) Deflate the balloon 40 according to standard procedures: apply negative pressure to the balloon 40 for about 30 to 120 seconds until the balloon 40 becomes empty, and then carefully withdraw the balloon dilatation catheter 100 from the blood vessel.

[0054] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A balloon dilatation catheter, characterized in that: The balloon dilatation catheter comprises: A tip and an inner tube, wherein the tip and the inner tube are sequentially connected from the distal end to the proximal end, the tip and the inner tube are both hollow structures, and are interconnected to form a conducting channel, wherein the tip is a multi-layer structure; The balloon and the outer tube are sequentially sleeved on the periphery of the inner tube from the distal end to the proximal end, and a delivery channel communicating with the balloon is formed between the outer tube and the inner tube.

2. The balloon dilatation catheter according to claim 1, characterized in that: The tip comprises an inner layer, a middle layer and an outer layer arranged in sequence from the inside to the outside, and the material of the inner layer comprises a block polyetheramide resin; The material of the middle layer includes low-density polyethylene; The material of the outer layer includes high-density polyethylene.

3. The balloon dilatation catheter according to claim 1, characterized in that: The length of the tip ranges from 2-10 mm.

4. The balloon dilatation catheter according to claim 1, characterized in that: The material of the balloon includes silica gel.

5. The balloon dilatation catheter according to claim 1, characterized in that: The balloon comprises a head, a middle section and a tail section connected in sequence from the distal end to the proximal end, and the middle section is cylindrical after being expanded; The length of the middle portion is 20-100 mm.

6. The balloon dilatation catheter according to claim 1, characterized in that: The inner tube is provided with a development mark, and the development mark is located inside the balloon; Wherein, the material of the development mark includes platinum-iridium alloy.

7. The balloon dilatation catheter according to claim 1, characterized in that: The length of the inner tube ranges from 90 to 150 mm.

8. The balloon dilatation catheter according to claim 1, characterized in that: A preset area on the outer peripheral surface of the outer tube is coated with a hydrophilic material, wherein the hydrophilic material comprises polyvinyl pyrrolidone; Furthermore, in the extension direction of the outer tube, the length of the preset area ranges from 33 cm to 37 cm.

9. The balloon dilatation catheter according to claim 1, characterized in that: The balloon dilatation catheter also includes: The stress diffusion tube is configured as a hollow structure, wherein the tip, the inner tube and the stress diffusion tube are sequentially connected from the distal end to the proximal end, and the stress diffusion tube is also connected to the outer tube, and the stress diffusion tube is provided with a first channel connected to the conduction channel and a second channel connected to the delivery channel; A connecting seat is connected to the stress diffusion tube and includes a first branch pipe communicating with the first channel and a second branch pipe communicating with the second channel.

10. The balloon dilatation catheter according to claim 9, characterized in that: A one-way valve is provided in the second branch pipe for controlling the opening and closing of the second channel.

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