WO2022121841A1

WO2022121841A1 - Proximal outer tube, balloon catheter, and stent system

Info

Publication number: WO2022121841A1
Application number: PCT/CN2021/135722
Authority: WO
Inventors: 赵瑞辉; 王龙飞; 岳斌
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2020-12-11
Filing date: 2021-12-06
Publication date: 2022-06-16
Also published as: CN114617685A

Abstract

A proximal outer tube (1), a balloon catheter, and a stent system. The proximal outer tube (1) is at least divided into two sections along the axial direction; the distal end of the proximal outer tube (1) is a delivery wire (101); the proximal end of the proximal outer tube (1) is a single-lumen tube (103); and the delivery wire (101) is connected to the single-lumen tube (103). The balloon catheter comprises a single-lumen structure provided at the proximal end of the balloon catheter and a double-lumen structure provided at the distal end of the balloon catheter, wherein the single-lumen structure is connected to the double-lumen structure, and a balloon (3) is provided at the distal end of the double-lumen structure. The stent system comprises a stent and a balloon catheter, wherein the stent is loaded outside the balloon catheter. Since the proximal outer tube (1) is at least divided into two sections along the axial direction, the proximal outer tube (1) has different physical properties in the axial direction to improve the tracking performance and the pushing performance of the proximal outer tube (1), thus facilitating better control and pushing of the balloon catheter by a doctor during a surgery, so that the balloon catheter can reach a narrow bending diseased area along a guide wire.

Description

Proximal Tubes, Balloon Catheters and Stent Systems

technical field

The invention relates to the technical field of medical devices, in particular to a proximal and outer tube, a balloon catheter and a stent system.

Background technique

Coronary heart disease (CHD) has become a major health problem in today's society, and percutaneous coronary intervention (PCI) is a very common coronary revascularization procedure because of its minimal trauma. , High success rate, has become an important means of coronary heart disease treatment.

Coronary stenting is one of the most widely used techniques in PCI, which can significantly reduce restenosis after PTCA (percutaneous transluminal coronary angioplasty), can deal with dissection and acute vascular occlusion, and become a coronary intervention therapy. another milestone. At the same time, people's blood vessels are getting thinner and thinner, and the lesions are becoming more and more complex, which puts forward higher and higher requirements for clinicians and equipment. For lesions that can be reached and treated by a vascular stent, the vascular stent needs to reach the lesion location along the guide wire under the delivery of the conveyor, so there is a high requirement for the pushing performance of the stent conveyor.

Usually, the stent delivery device is designed with a balloon catheter, which requires a high strength at the proximal end to provide and transmit sufficient pushing force, and sufficient flexibility at the distal end to conform to the narrow and tortuous shape of the blood vessel. Blood vessel. Therefore, in the prior art stent delivery, the proximal tube section (commonly referred to as the "proximal outer tube") is mostly designed with an ordinary stainless steel single-lumen tube, while the outer tube, inner tube and bulb in the distal part of the delivery device The bag is mostly made of polymer tubing. However, this will lead to abrupt changes in material and structure at the junction of the proximal and outer tubes and the distal component, which will affect the doctor's use process. The pushing force generated by the user on the proximal and outer tubes cannot be effectively transmitted to the distal end of the conveyor and the stent portion, thereby reducing the pushing performance. At the same time, as the diseased blood vessels become more and more complex, higher requirements are also placed on the tracking of the conveyor.

SUMMARY OF THE INVENTION

In view of the above disadvantages of the prior art, the purpose of the present invention is to provide a proximal outer tube, a balloon catheter and a stent system. Compared with the prior art, the present invention can improve the pushing performance of the coronary stent system without reducing the traceability, and improve the product performance to cure the tortuous and narrow lesions.

For achieving the above object, technical scheme of the present invention is as follows:

The proximal and outer tube is divided into at least two sections along the axial direction, the distal end of the proximal and outer tube is a transmission wire, and the proximal end of the proximal and outer tube is a single-lumen tube, and the transmission wire and the Single lumen tubes are connected.

Further, the material of the single-lumen tube and/or the delivery wire is one metal or a combination of multiple metals, and the single-lumen tube and the delivery wire are made of the same or different materials.

Further, the material of the single lumen tube and/or the transmission wire is stainless steel.

Further, the material of the single-lumen tube is 304L stainless steel, and the material of the transmission wire is 304 stainless steel.

Further, the outer surface of the single-lumen tube has at least one layer of polymer to reduce the friction coefficient of the outer surface of the single-lumen tube.

Further, the polymer includes one or a combination of polyamide, polyester, polytetrafluoroethylene, polyvinylidene fluoride, polyamide polyether block copolymer, polyethylene, and polyimide.

Further, the distal end of the single-lumen tube includes a hypotube.

Further, the tube wall of the hypotube has at least one threaded slot, and the threaded slot penetrates the tube wall of the hypotube along its radial direction.

Further, when there are more than two thread slits, the widths of each thread slit are the same or different, and the distances between adjacent thread slits are the same or different.

Further, when the distances are different, the distance between the adjacent thread slits is 0.5mm˜5mm.

Further, the distal mouth of the hypotube is any one of a straight mouth or a slope mouth.

Further, the transmission wire is integrally formed with the single-lumen tube.

Further, the diameter of the transmission wire is constant or gradual or abrupt along the axial direction, and the diameter of the transmission wire ranges from 0.002 inch to 0.012 inch.

Further, the length of the transmission wire ranges from 25 mm to 200 mm.

Further, the inner diameter of the lumen of the single-lumen tube is 0.0160 inch to 0.0220 inch, and the outer diameter of the lumen of the single lumen tube is 0.0230 inch to 0.0300 inch.

A balloon catheter, comprising a single-lumen structure disposed at the proximal end of the balloon catheter and a double-lumen structure disposed at the distal end of the balloon catheter, the single-lumen structure is connected with the double-lumen structure, and the double-lumen structure is located in the double-lumen structure. The distal end of the balloon is set;

Further, the single-lumen structure comprises the proximal and outer tube and the connecting piece according to claims 1-14;

Further, the double-lumen structure includes a distal outer tube and an inner tube, and the inner tube is coaxial with the distal outer tube and is disposed inside the distal outer tube.

Further, at least one developing point is arranged on the outer surface of the inner tube.

A stent system comprising a stent and a balloon catheter as claimed in claim 15 or 16, the stent being loaded on the outside of the balloon of the balloon catheter.

Compared with the prior art, the beneficial technical effects of the present invention are as follows:

(1) The proximal and outer tubes of the present invention are at least divided into two sections along the axial direction, so that the proximal and outer tubes have different physical properties in the axial direction, and the tracking and pushing properties of the proximal and outer tubes are improved, which is convenient for doctors to better perform operations during the operation. Control and push the balloon catheter, so that the balloon catheter can reach the narrow and tortuous lesions along the guide wire.

(2) Further, the distal end of the proximal and outer tubes is provided with a transmission wire, which can provide necessary mechanical support for the distal end of the balloon catheter and the stent, but at the same time will not affect the flexibility of the distal end of the balloon catheter and the overall proximal and outer tubes. The proximal end of the proximal and outer tube is a single-lumen tube, which can ensure that the pushing force is stably transmitted to the distal end of the balloon catheter; both maximize the pushing efficiency.

(3) Further, materials with appropriate strength and stiffness are selected for the transmission wire and the single-lumen tube, so that the proximal and outer tubes have both superior tracking and pushing properties, which can ensure that the pushing force is stably transmitted to the distal end of the balloon catheter, and The stent can be delivered to narrow tortuous lesions.

(4) Further, the distal end of the single-lumen tube is a hypotube, which can achieve good bending performance without affecting the pushing efficiency, so as to improve the ability of the stent delivery device to pass through tortuous lesions.

Description of drawings

FIG. 1 shows a schematic structural diagram of the balloon catheter in the proximal and outer tube, balloon catheter and stent system of the present invention.

FIG. 2 shows a schematic structural diagram of a proximal and outer tube in a proximal and outer tube, a balloon catheter and a stent system according to an embodiment of the present invention.

Fig. 3 shows a schematic structural diagram of the proximal and outer tubes in the proximal and outer tubes, the balloon catheter and the stent system according to the second embodiment of the present invention.

FIG. 4 shows a schematic structural diagram of the proximal and outer tubes in the proximal and outer tubes, the balloon catheter and the stent system according to the third embodiment of the present invention.

Fig. 5 shows a schematic structural diagram of the proximal and outer tubes in the proximal and outer tubes, the balloon catheter and the stent system according to the fourth embodiment of the present invention.

Marked in the attached drawing:

1, proximal outer tube; 101, transmission wire; 1011, first filament; 1012, second filament; 102, hypotube; 103, single lumen tube; 104, marker tape; 200, distal outer tube; 201, Inner tube; 202, developing point; 3, balloon.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present invention clearer, the proximal and outer tubes, balloon catheters and stent systems proposed by the present invention will be described in further detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in a very simplified form and all use inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. For the purpose, features and advantages of the present invention to be more clearly understood, please refer to the accompanying drawings. It should be noted that the structures, proportions, sizes, etc. shown in the drawings in this specification are only used to cooperate with the contents disclosed in the specification, so as to be understood and read by those who are familiar with the technology, and are not used to limit the implementation of the present invention. Therefore, it does not have technical substantive significance, and any modification of structure, change of proportional relationship or adjustment of size should still fall within the scope of the present invention without affecting the effect that the present invention can produce and the purpose that can be achieved. The scope of the disclosed technical content can be covered.

In order to describe the above-mentioned proximal and outer tubes, balloon catheters and stent systems more clearly, the present invention defines the terms "distal end" and "proximal end", which are special terms in the field of medical devices. Specifically, "distal end" means The end away from the operator during the operation, "proximal end" means the end close to the operator during the operation, take Figure 2 as an example, the right side of the proximal and outer tubes in Figure 2 is the proximal end, and the left side of the proximal and outer tubes in Figure 2 The side is the distal end.

A stent system includes a stent and a balloon catheter, wherein the stent is installed outside the balloon catheter.

The following describes the specific structure of the balloon catheter as follows:

Please refer to FIG. 1, which shows a schematic structural diagram of a balloon catheter, wherein the balloon catheter includes a single-lumen structure and a double-lumen structure, the single-lumen structure is located at the proximal end of the balloon catheter, and the double-lumen structure is located at the proximal end of the balloon catheter. The cavity structure is located at the distal end of the balloon catheter, the single cavity structure is connected with the double cavity structure, a balloon 3 is arranged at the distal end of the balloon catheter, and the balloon is made of polymer material and is used as a stent and dilation of diseased blood vessels.

Please continue to refer to FIG. 1 , the dual-chamber structure includes a distal outer tube 200 and an inner tube 201 . The inner tube 201 is coaxial with the distal outer tube 200 and is disposed inside the distal outer tube 200 . At least one developing point 202 is provided on the outer surface of the inner tube 201, so that the doctor can observe the specific position of the balloon or the working segment of the balloon under X-rays during the interventional operation. The outer tube 200 and/or the inner tube 201 in the dual-chamber structure can be made of conventional materials, usually high molecular polymers, such as nylon, polytetrafluoroethylene, etc., which will not be repeated here.

Please continue to refer to FIG. 1 , the single-lumen structure can be used as a fluid-passing chamber to deliver contrast fluid to expand the balloon 3 , and the single-lumen structure is composed of a proximal outer tube 1 and a connecting piece, and the connecting piece is a connection with a luer connector The luer connector is used to connect the proximal end of the proximal outer tube 1 with the inflator used by the operator to deliver contrast fluid. The distal end of the proximal and outer tube 1 is connected with the proximal end of the above-mentioned distal and outer tube 200, the proximal end of the proximal and outer tube 1 is connected with the connecting piece, and the proximal end of the proximal and outer tube 1 is connected with the connecting piece. The method includes but is not limited to any one of heat shrinking or glue bonding or welding. In some embodiments of the present invention, the connection between the distal end of the proximal outer tube 1 and the proximal end of the distal outer tube 200 may be connected by welding, riveting, or bonding.

Further, please continue to refer to FIG. 1 , a marker band 104 is also provided on the proximal outer tube 1 , and the marker band 104 is used to indicate the length of the present invention entering the human body for the operator, which is convenient for the operator to further operate.

Correspondingly, in an embodiment of the present invention, the present invention further provides a stent system, the stent system includes a stent and the balloon catheter, and the stent is loaded on the balloon 3 of the balloon catheter. external. The specific structure of the balloon catheter has been described above, and will not be repeated here.

The specific structure of the proximal outer tube 1 will be described below by way of embodiments.

Example 1:

Referring to FIG. 2 , the proximal and outer tube 1 is divided into at least two sections in the axial direction, and in the first embodiment, there are two sections. The distal end of the proximal and outer tube 1 is a transmission wire 101 . The inner wall or outer wall of the proximal end of the distal outer tube 200 is welded (for example, by laser welding), the proximal end of the proximal outer tube 1 is a single-lumen tube 103, the distal end of the single-lumen tube 103 is a hypotube 102, and the The hypotube 102 at the distal end of the single-lumen tube 103 is connected to the transmission wire 101. The hypotube 102 is used as the metal tube body at the proximal end of the balloon catheter and will enter the human body during the interventional operation. The hypotube 102 can meet the requirements of mechanical transmission and bending performance during the interventional operation at the same time, and further improve the overall pushing performance of the present invention.

Of course, in other embodiments of the present invention, the transmission wire 101 and the inner wall or outer wall of the proximal end of the distal outer tube 200 can also be connected by means of riveting, bonding, etc., as long as the transmission wire 101 and the The proximal end of the distal outer tube 200 may be connected, which is not limited in the present invention.

Referring to FIG. 2 , the inner diameter of the single-lumen tube 103 in the proximal outer tube 1 is 0.0160-0.0220 inch. In the first embodiment of the present invention, the inner diameter of the single-lumen tube 103 is preferably 0.0160-0.0200 inch. The outer diameter of the single lumen tube 103 in the proximal outer tube 1 is 0.0230-0.0300 inch. In the first embodiment of the present invention, the outer diameter of the single lumen tube 103 is preferably 0.0230-0.0260 inch. The material of the single-lumen tube 103 and/or the delivery wire 101 in 1 is a metal or a combination of multiple metals, preferably, the material of the single-lumen tube 103 and/or the delivery wire 101 in the proximal outer tube 1 is stainless steel, Specifically, for example, it can be a combination of one or more of nickel, titanium, and tungsten. Among them, the combination of multiple metals includes mixing, joining, fitting, and the like.

The structure of the single-lumen tube 103 in this embodiment is described below:

Please continue to refer to FIG. 2 , further, the distal end of the single-lumen tube 103 includes a hypotube 102 , the hypotube 102 is connected with the single-lumen tube 103 , and is on the outer surface of the single-lumen tube 103 At least one layer of polymer is provided to reduce the coefficient of friction of the outer surface of the single lumen tube 103 to improve biocompatibility. The polymer includes one or a combination of polyamide, polyester, polytetrafluoroethylene, polyvinylidene fluoride, polyamide polyether block copolymer, polyethylene, polyimide. Preferably, the single-lumen tube 103 is made of 304L stainless steel, the length of the hypotube 102 is 120mm-135mm, the polymer is PTFE (polytetrafluoroethylene), and the starting point of the polymer is away from the hypotube 102 The distal end of the polymer is 20mm away from the proximal end of the single-lumen tube 103 for easier connection of the hypotube 102 and the single-lumen tube 103 and to improve its bonding strength, and the end point of the polymer is 85mm away from the proximal end of the single-lumen tube 103 to improve the The connection strength between the single lumen tube 103 and the distal outer tube 200 is described.

Further, the distal nozzle of the hypotube 102 is a sloped opening, and the sloped opening can improve the anti-buckling performance of the distal nozzle of the hypotube 102 . The slope port makes the distal end face of the hypotube 102 be a slope, and the slope and the axis of the hypotube form an angle greater than 0° and less than 90°. The tube wall of the hypotube 102 has at least one threaded slot, and the threaded slot penetrates the tube wall of the hypotube 102 . The threads are formed by laser cutting, and when there are more than one thread slits, the widths of the thread slits are the same or different.

Correspondingly, in another embodiment of the present invention, the distal mouth of the hypotube 102 may also be a straight mouth, and the straight mouth makes the distal end face of the hypotube 102 perpendicular to the hypotube axis.

Preferably, in the hypotube 102 provided in the first embodiment, there are multiple thread slits, the width of the thread slits is the same, the spacing between adjacent thread slits is different, and the spacing between adjacent thread slits is from the distal end to the proximal end Gradually increase from 1.0mm to 4.52mm.

The specific structure of the transmission wire 101 in this embodiment is described below:

The diameter of the transmission wire 101 is constant, gradual or abrupt in the axial direction, and the diameter of the transmission wire 101 varies from 0.002 inch to 0.012 inch. The length of the transmission wire 101 is any length between 70 mm and 100 mm. The material of the transmission wire 101 is one metal or a combination of multiple metals, and the material of the transmission wire 101 is stainless steel, specifically, for example, one or a combination of nickel, titanium, and tungsten.

Preferably, in the first embodiment, the diameter of the transmission wire 101 is gradual in the axial direction, and increases linearly from the distal end to the proximal end of the transmission wire 101. The diameter of the transmission wire 101 varies from 0.002 inch to 0.010 inch, preferably Yes, the transmission wire 101 is made of 304 stainless steel, the length of the transmission wire 101 is 100mm, and the cross section is circular.

Preferably, in the first embodiment, the diameter of the proximal end of the transmission wire 101 is smaller than the inner diameter of the hypotube 102 , and the transmission wire 101 is welded to the distal end of the hypotube 102 by laser.

Correspondingly, in other embodiments of the present invention, the transmission wire 101 and the single-lumen tube 103 may also be connected to form an integrated structure, and the hypotube 102 at the distal end of the single-lumen tube 103 may also be connected to the single-lumen tube 103. The single-lumen tube 103 is integrally formed, it only needs to satisfy that the delivery wire 101 can be connected with the single-lumen tube 103 , and the hypotube 102 can be formed with the distal end of the single-lumen tube 103 and connected with the delivery wire 101 .

Embodiment 2:

Referring to FIG. 3 , the proximal and outer tube 1 is divided into at least two sections along the axial direction, and in the second embodiment, there are two sections. The distal end of the proximal and outer tube 1 is the transmission wire 101 , and the proximal end of the proximal outer tube 1 is It is a single-lumen tube 103 , the distal end of the single-lumen tube 103 is a hypotube 102 , and the transmission wire 101 is connected to the hypotube 102 at the distal end of the single-lumen tube 103 .

The inner diameter of the single-lumen tube 103 in the proximal outer tube 1 is 0.0160 inch-0.0220 inch, and in the second embodiment of the present invention, the inner diameter of the single-lumen tube 103 is preferably 0.0160 inch-0.0210 inch. The outer diameter of the single-lumen tube 103 in 1 is 0.0230-0.0300 inch, and the outer diameter of the single-lumen tube 103 in the first embodiment of the present invention is preferably 0.0230-0.0270 inch. The material of the proximal outer tube 1 is one metal or a combination of multiple metals, and the material of the proximal outer tube 1 is stainless steel, specifically, for example, one or a combination of nickel, titanium, and tungsten.

The structures of the single-lumen tube 103 and the hypotube 102 in the second embodiment are the same as those in the first embodiment, and the difference is the structure of the transmission wire 101, specifically:

The diameter of the transmission wire 101 in the axial direction is gradually changing, and it has a first filament 1011 with a constant diameter and a second filament 1012 with a variable diameter, wherein in the third embodiment, the distal end of the transmission wire 101 The diameter of the first filament 1011 is 0.003 inch and the length is 30 mm. The proximal part of the transmission wire 101 , ie the diameter of the second filament 1012 is gradually changed from the distal end of the second filament 1012. The end to the proximal end increases linearly, and the diameter of the second filament 1012 varies from 0.003 inch to 0.010 inch. Preferably, the transmission wire 101 is made of 304 stainless steel, the length of the transmission wire 101 is 130 mm, and the cross section is circular .

Preferably, in the second embodiment, the diameter of the proximal end of the transmission wire 101 is smaller than the inner diameter of the hypotube 102, and the transmission wire 101 is welded to the distal end of the hypotube 102 by laser.

Embodiment three:

Referring to FIG. 3 , the proximal and outer tube 1 is divided into at least two sections in the axial direction, and in the third embodiment, there are two sections. The distal end of the proximal and outer tube 1 is the transmission wire 101 , and the proximal end of the proximal outer tube 1 is It is a single-lumen tube 103 , the distal end of the single-lumen tube 103 is a hypotube 102 , and the transmission wire 101 is connected to the hypotube 102 at the distal end of the single-lumen tube 103 .

The structure of the single-lumen tube 103 in the third embodiment is the same as that of the second embodiment, and the structure of the hypotube 102 is different from that of the hypotube 102 in the second embodiment, and the details are as follows:

Preferably, in the hypotube 102 provided in the third embodiment, there are multiple thread slits, the width of the thread slits is the same, the spacing between adjacent thread slits is different, and the spacing between adjacent thread slits is from the distal end to the proximal end Gradually increase from 1.10mm to 4.52mm.

The structure of the transmission wire 101 is different from that of the transmission wire 101 in the second embodiment as follows:

The diameter of the transmission wire 101 in the axial direction is gradual, and increases linearly from the distal end to the proximal end of the transmission wire 101. The diameter of the transmission wire 101 varies from 0.003 inch to 0.010 inch. The material of the transmission wire 101 is: 304 stainless steel, the length is 100mm, and the cross-section is crescent-shaped. In other embodiments of the present invention, the cross-section may also be circular or rectangular.

Preferably, in the third embodiment, the diameter of the proximal end of the transmission wire 101 is smaller than the inner diameter of the hypotube 102 , and the transmission wire 101 is welded to the distal end of the hypotube 102 by laser.

Embodiment 4:

Referring to FIG. 5 , the proximal and outer tube 1 is divided into at least two sections in the axial direction, and in the fourth embodiment, there are two sections. The distal end of the proximal and outer tube 1 is the transmission wire 101 , and the proximal end of the proximal outer tube 1 It is a single-lumen tube 103 , the distal end of the single-lumen tube 103 is a hypotube 102 , and the transmission wire 101 is connected to the hypotube 102 at the distal end of the single-lumen tube 103 .

The structures of the single-lumen tube 103 and the hypotube 102 in the fourth embodiment are the same as those in the first embodiment, and the difference is the structure of the transmission wire 101, specifically:

The diameter of the transmission wire 101 is gradual in the axial direction, and increases linearly from the distal end to the proximal end of the transmission wire 101. The diameter of the transmission wire 101 varies in the range of 0.002 inch to 0.008 inch. Nickel-titanium alloy, the length of the transmission wire 101 is 100 mm, and the cross-section is circular.

Correspondingly, in other embodiments of the present invention, the proximal outer tube 1 can be used as the middle tube section of the entire balloon catheter, so that the proximal end of the balloon catheter can be connected to the connector through other catheter structures.

The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.

The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims

The proximal and outer tube is characterized in that: the proximal and outer tube is divided into at least two sections in the axial direction, the distal end of the proximal and outer tube is a transmission wire, the proximal end of the proximal and outer tube is a single-lumen tube, and the transmission A wire is connected to the single lumen tube.
The proximal outer tube according to claim 1, wherein the material of the single-lumen tube and/or the delivery wire is a metal or a combination of multiple metals, and the single-lumen tube and the delivery wire are made of one metal or a combination of multiple metals. the same or different materials.
The proximal outer tube according to claim 2, wherein the material of the single lumen tube and/or the delivery wire is stainless steel.
The proximal outer tube of claim 1, wherein the outer surface of the single-lumen tube has at least one layer of polymer to reduce the friction coefficient of the outer surface of the single-lumen tube.
The proximal outer tube of claim 4, wherein the polymer comprises polyamide, polyester, polytetrafluoroethylene, polyvinylidene fluoride, polyamide polyether block copolymer, polyethylene, polyamide A combination of one or more of the imines.
The proximal-outer tube of claim 1, wherein the distal end of the single-lumen tube comprises a hypotube.
The near-outer tube according to claim 6, wherein the tube wall of the hypotube has at least one threaded slot, and the threaded slot penetrates the tube wall of the hypotube along its radial direction.
The near-outer tube according to claim 7, wherein when there are more than two threaded slits, the widths of each of the threaded slits are the same or different, and the distances between the adjacent threaded slits are the same or different .
The near-outer tube according to claim 8, wherein when the distances are different, the distance between the adjacent thread slits is 0.5mm˜5mm.
The near-external tube according to claim 6, wherein the distal nozzle of the hypotube is any one of a straight opening or a slope opening.
The proximal-outer tube of claim 1, wherein the delivery wire is integrally formed with the single-lumen tube.
The near-outer tube according to claim 1, wherein the diameter of the transmission wire is constant or gradual or abrupt in the axial direction, and the diameter of the transmission wire ranges from 0.002 inch to 0.012 inch.
The near-outer tube according to claim 1, wherein the length of the transmission wire ranges from 25 mm to 200 mm.
The proximal-outer tube according to claim 1, wherein the inner diameter of the single-lumen tube is 0.0160 inch-0.0220 inch, and the outer diameter of the single-lumen tube is 0.0230 inch-0.0300 inch.
A balloon catheter is characterized in that: it comprises a single-lumen structure arranged at the proximal end of the balloon catheter and a double-lumen structure arranged at the distal end of the balloon catheter, the single-lumen structure is connected with the double-lumen structure, and the A balloon is arranged at the distal end of the double-chamber structure;

The single-lumen structure comprises the proximal and outer tube and the connector according to claims 1-14;

The dual-lumen structure includes a distal outer tube and an inner tube, the inner tube is coaxial with the distal outer tube and is disposed inside the distal outer tube.
The balloon catheter of claim 16, wherein at least one imaging point is provided on the outer surface of the inner tube.
A stent system, characterized by comprising a stent and the balloon catheter according to claim 15 or 16, wherein the stent is loaded on the outside of the balloon of the balloon catheter.