Balloon catheter

Abstract

The present invention provides a balloon catheter, which includes a balloon body, an inner lumen tube and a distal end tube. The inner lumen tube penetrates through the balloon body. The distal end tube is connected to the distal end of the balloon body and / or the distal end of the inner lumen tube. The inner lumen tube and / or the distal end tube include a support layer, and the support layer is composed of wire materials. The inner lumen tube and / or the distal end tube further include an inner layer located inside the support layer and / or an outer layer located outside the support layer. At least one groove is provided on at least one surface of the support layer. By adding a support layer in the inner lumen tube and / or the distal end tube, the present invention ensures that the inner lumen tube and / or the distal end tube will not deform and hold the guide wire tightly. And grooves are provided on the surface of the support layer to increase the bonding contact area between the support layer and other layers of the inner lumen tube, improve the bonding strength between two or more layers, and avoid delamination during use.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a balloon catheter. Background Art

[0002] Ischemic stroke is mainly caused by vascular stenosis, occlusion / hemodynamics or blood component changes, resulting in insufficient oxygen and nutrient carrying capacity of the blood or reduced ability to remove metabolic products, and the death of brain neurons / glial cells and blood vessels, accounting for about 80% of cerebrovascular diseases. Cerebrovascular stenosis is an important cause and risk factor for ischemic cerebrovascular diseases. Currently, the main treatment methods for treating cerebrovascular stenosis are as follows:

[0003] (i) Drug treatment, combined with antiplatelet aggregation / lipid-lowering drugs to delay the progression of carotid stenosis and improve cerebrovascular reactivity;

[0004] (ii) Extracranial-intracranial bypass: For symptomatic intracranial stenosis patients with severe hemodynamic disorders, extracranial-intracranial bypass may improve brain tissue engineering / reduce the recurrence rate of stroke;

[0005] (iii) Endovascular treatment: For symptomatic intracranial stenosis ≥70% that is ineffective with the best drugs or has poor cerebral collateral circulation compensation, balloon angioplasty or stent implantation is used to dilate the stenotic blood vessel to restore the vascular access. Generally, the intracranial stenotic blood vessels are relatively tortuous and complex, the blood vessel diameter is also small, and the stenotic part is located at a relatively distal part of the blood vessel, such as the C6-C7 position, M1-M2 position, etc. Therefore, for balloon angioplasty, the balloon catheter needs to have good passability and positioning ability so that the doctor can smoothly deliver the balloon catheter to the lesion location; in addition, the ability of the balloon catheter to be imaged is also an important functional index. Through balloon imaging, the doctor can accurately locate the position of the balloon to ensure the accurate performance of balloon dilation.

[0006] Currently, during treatment, the balloon catheter needs to be filled to a certain pressure to dilate the stenotic lesion. Therefore, the inner lumen tube needs to have a certain strength to resist the pressure during balloon filling to ensure that the inner lumen tube does not deform and hold the guide wire tightly, resulting in the inability of the balloon catheter to track the guide wire forward. Generally, the inner lumen tube is composed of multiple layers of materials, and delamination may occur during balloon filling. If delamination occurs, the strength of the inner lumen tube will be reduced. In addition, intracranial balloon catheters all set one or two metal rings on the outer wall of the inner tube to achieve the function of balloon imaging and indicate the working length of the balloon. On the premise of meeting the imaging requirements, the metal ring needs to have a certain wall thickness and length. Since the metal ring is difficult or impossible to be compressed, it may become the part with the largest outer diameter on the balloon body. At the same time, due to its metal properties, it has disadvantages such as non-bendable / poor flexibility in tortuous and complex lesions, resulting in folding of the inner lumen tube, poor pushing performance, and even inability to reach the lesion location, affecting the surgical results.

[0007] Similar to the inner lumen tube but different, the tip of the balloon catheter, as the farthest end of the entire balloon catheter system, is too soft and easily damaged, which affects the tracking and pushability of the balloon catheter. If it is too hard, it will be difficult for the balloon catheter to pass through tortuous lesions and requires a certain degree of flexibility. When the balloon catheter is pushed by a doctor into the blood vessel, if the tip has a double-layer or multi-layer structure, it may deform or delaminate under the external pressure of the blood vessel wall, resulting in the inability of the tip of the balloon catheter to fit well with the guide wire, poor tracking and pushability of the balloon catheter, and even the inability to reach the lesion location, affecting the surgical outcome. Summary of the Invention

[0008] Aiming at the problems in the prior art, the purpose of the present invention is to provide a balloon catheter, which adds a support layer in the inner lumen tube and / or the tip tube to ensure that the inner lumen tube and / or the tip tube will not deform and hold the guide wire tightly, and grooves are provided on the surface of the support layer to increase the bonding contact area between the support layer and other layers of the inner lumen tube, improve the bonding strength between two or more layers, and avoid delamination during use.

[0009] An embodiment of the present invention provides a balloon catheter, including a balloon body, an inner lumen tube and a tip tube. The inner lumen tube penetrates the balloon body. The tip tube is connected to the distal end of the balloon body and / or the distal end of the inner lumen tube. The inner lumen tube and / or the tip tube includes a support layer, and the support layer is composed of wire.

[0010] The inner lumen tube and / or the tip tube further includes an inner layer located inside the support layer and / or an outer layer located outside the support layer, and at least one groove is provided on at least one surface of the support layer.

[0011] In some embodiments, the support layer is formed by helically winding the wire into a spring structure, or the support layer is formed by cross-weaving the wire into a woven structure, or the support layer includes a combination of a helically wound spring structure and a cross-woven woven structure.

[0012] In some embodiments, the groove extends along the extension direction of the wire, or the groove includes a plurality of pits distributed on the surface of the wire.

[0013] In some embodiments, the width of the wire is 0.0005 inches to 0.006 inches, and / or the thickness of the wire is 0.0005 inches to 0.006 inches;

[0014] The width of the groove is 3μm to 80μm, and / or the depth of the groove is 3nm to 30μm.

[0015] In some embodiments, the ratio of the width of the groove to the width of the wire is greater than 0 and less than or equal to 1 / 2, and / or the ratio of the depth of the groove to the thickness of the wire is greater than 0 and less than or equal to 1 / 2.

[0016] In some embodiments, the wire is a developable wire.

[0017] In some embodiments, the developable wire is a metal wire or a polymer wire doped with a developer.

[0018] In some embodiments, the balloon body includes a straight section and a first transition section located on the distal side of the straight section. The inner lumen tube includes a first region corresponding to the straight section and a second region corresponding to the first transition section. The density of the wires of the support layer at the first region is different from the density of the wires of the support layer at the second region.

[0019] In some embodiments, the support layer is formed by helically winding the wires, or the support layer is formed by cross-weaving the wires;

[0020] The density of the wires of the support layer at the first region is 500 - 800 helical or woven nodes per unit inch, and the density of the wires of the support layer at the second region is 200 - 300 helical or woven nodes per unit inch.

[0021] In some embodiments, both the inner lumen tube and the end tube include the support layer, and the density of the wires of the support layer at the end tube is different from the density of the wires of the support layer at the second region.

[0022] In some embodiments, the density of the wires of the support layer at the end tube is between the density of the wires of the support layer at the first region and the density of the wires of the support layer at the second region of the inner lumen tube, or the density of the wires of the support layer at the end tube is the same as the density of the wires of the support layer at the first region.

[0023] In some embodiments, the balloon body includes a straight section, the inner lumen tube includes a first region corresponding to the straight section, the first region includes a central region, an end region, and a connection region located between the central region and the end region, and the density of the wires of the support layer at the connection region is different from the density of the wires of the support layer at the central region and the end region.

[0024] In some embodiments, the inner layer and / or the outer layer is a polymer layer at least partially doped with a developer.

[0025] In some embodiments, the balloon body includes a flat section, and a part of the inner layer and / or the outer layer corresponding to the flat section of the balloon is doped with a developer, and / or a part of the inner layer and / or the outer layer corresponding to the terminal tube is doped with a developer.

[0026] The balloon catheter provided by the present invention has the following advantages:

[0027] The present invention provides a balloon catheter. By adding a support layer in the inner lumen tube and / or the terminal tube, it is ensured that the inner lumen tube and / or the terminal tube will not be deformed, avoiding the problems of the inner lumen tube clamping the guide wire and / or the terminal tube being bent. And grooves are provided on the surface of the support layer to increase the bonding contact area between the support layer and other layers of the inner lumen tube, improving the bonding strength between two or more layers and avoiding delamination during use. When adding a support layer in the inner lumen tube, it can more effectively ensure that while the inner lumen tube supports the balloon inflation, the own lumen of the inner lumen tube will not be deformed, that is, the phenomenon that the inner lumen tube clamps the guide wire and the balloon catheter cannot track the guide wire for delivery will not occur. When adding a support layer in the terminal tube, it can avoid the deformation or delamination of the terminal tube under external pressure during use, affecting the pushing performance. The balloon catheter of the present invention can be an intracranial balloon catheter or a balloon catheter for blood vessels or body lumens in other parts.

[0028] Further, in some embodiments, the support layer of the present invention can be composed of developer wires. The imaging effect of the balloon catheter is achieved through the support layer, and the imaging intensity in different regions can be adjusted by adjusting the density of the wires in different regions, which is more convenient for doctors to determine the positions of various regions of the balloon catheter through the imaging effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Other features, objects, and advantages of the present invention will become more apparent by reading the detailed description of the non-limiting embodiments with reference to the following drawings.

[0030] Figure 1 is a schematic structural diagram of the balloon catheter according to the first embodiment of the present invention;

[0031] Figure 2 is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter according to the first embodiment of the present invention;

[0032] Figure 3 is a schematic structural diagram of the first support layer according to the first embodiment of the present invention;

[0033] Figure 4 is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter according to the second embodiment of the present invention;

[0034] Figure 5 is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter according to the third embodiment of the present invention;

[0035] Figure 6 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the fourth embodiment of the present invention;

[0036] Figure 7 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the fifth embodiment of the present invention;

[0037] Figure 8 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the sixth embodiment of the present invention;

[0038] Figure 9 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the seventh embodiment of the present invention;

[0039] Figure 10 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the eighth embodiment of the present invention;

[0040] Figure 11 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the ninth embodiment of the present invention;

[0041] Figure 12 It is a cross-sectional view of the distal end of the inner lumen tube and the terminal tube in the balloon catheter of the tenth embodiment of the present invention;

[0042] Figure 13 It is a schematic structural view of the second support layer of the tenth embodiment of the present invention.

[0043] Reference numerals:

[0044] 10 Balloon catheter 121 First region

[0045] 11 Balloon body 122 Second region

[0046] 111 Straight section 123 Third region

[0047] 112 First transition section 13 Terminal tube

[0048] 113 Second transition section 13a Second inner layer

[0049] 12 Inner lumen tube 13b Second support layer

[0050] 12a First inner layer 13b1 Second groove

[0051] 12b First support layer 13c Second outer layer

[0052] 12b1 First groove 14 Outer tube

[0053] 12c First outer layer 15 Diffusion stress tube

[0054] 12d The first bonding layer 16 balloon seat Detailed implementation mode

[0055] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in various forms, and the present invention should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present invention will be more complete and comprehensive, and the concept of the example embodiments will be fully conveyed to those skilled in the art. Like reference numerals in the figures denote the same or similar structures, and thus repeated descriptions thereof will be omitted. "Or" or "either...or" in the specification may mean "and" or "or".

[0056] The present invention provides a balloon catheter, comprising a balloon body, an inner lumen tube and a distal end tube. The inner lumen tube penetrates through the balloon body. The distal end tube is connected to the distal end of the balloon body and / or the distal end of the inner lumen tube. The inner lumen tube and / or the distal end tube comprise a support layer, which is composed of wire materials and is used for supporting the inner lumen tube to ensure that the inner lumen tube will not be deformed to clamp the guide wire. The inner lumen tube and / or the distal end tube further comprise an inner layer located inside the support layer and / or an outer layer located outside the support layer. At least one groove is arranged on at least one surface of the support layer to increase the bonding contact area between the support layer and other layers (inner layer and / or outer layer) of the inner lumen tube and improve the bonding strength between two or more layers. When adding the support layer to the inner lumen tube, the phenomenon of delamination when the balloon is inflated is avoided, so that it can more effectively ensure that the inner lumen tube supports the balloon inflation while the lumen of the inner lumen tube itself is not deformed, that is, the phenomenon that the inner lumen tube clamps the guide wire and the balloon catheter cannot track the delivery of the guide wire will not occur. When adding the support layer to the distal end tube, deformation or delamination of the distal end tube under external pressure during use can be avoided, which affects the tracking performance and pushing performance. The balloon catheter of the present invention can be an intracranial balloon catheter or a balloon catheter for blood vessels or body lumens in other parts.

[0057] The structure of the balloon catheter in each specific embodiment of the present invention will be described in detail below with reference to the accompanying drawings. It can be understood that each specific embodiment is not a limitation on the protection scope of the present invention.

[0058] As Figure 1 and Figure 2 shown, the first embodiment of the present invention provides a balloon catheter 10, comprising a balloon body 11 and an inner lumen tube 12. The inner lumen tube 12 penetrates through the balloon body 11. The inner lumen tube 12 is a multi-layer structure. As Figure 1As shown, the balloon catheter 10 further includes a distal end tube 13 located on the distal side of the inner lumen tube 12 and exposed outside the balloon body 11, an outer tube 14, a diffusion stress tube 15, and a balloon seat 16 that are sequentially connected on the proximal side of the inner lumen tube 12. The distal end of the balloon body 11 is fixed to the inner lumen tube 12, and the proximal end is fixed to the outer tube 14. The distal end of the inner lumen tube 12 is connected to the distal end tube 13, and the proximal end of the inner lumen tube 12 is located in the lumen of the distal end of the outer tube 14. Here, the distal end and the proximal end are relative to the operator. The end closer to the operator is the proximal end, and the end farther from the operator is the distal end.

[0059] As Figure 2 shown, in this embodiment, the inner lumen tube 12 includes a first support layer 12b, a first inner layer 12a located inside the first support layer 12b, and a first outer layer 12c located outside the first support layer 12b. The first inner layer 12a and the first outer layer 12c are preferably polymer layers. The first inner layer 12a is preferably a polymer with a low coefficient of friction, such as high-density polyethylene, POM (polyoxymethylene), polytetrafluoroethylene, or other fluoropolymers, to ensure smooth movement of the guide wire in the lumen of the inner lumen tube 12 when delivering the balloon catheter. The first outer layer 12c can be made of a combination of polymers with the same hardness or different hardnesses, such as made of polyamide, nylon, or a combination of polyamide and nylon (such as blending or splicing). In this embodiment, the distal end tube 13 is connected to the distal end of the inner lumen tube 12 and / or the distal end of the balloon body 11. The distal end tube 13 includes a second inner layer 13a, a second support layer 13b, and a second outer layer 13c. The second inner layer 13a and the second outer layer 13c are preferably polymer layers. The second inner layer 13a is preferably a polymer with a low coefficient of friction, such as high-density polyethylene, POM (polyoxymethylene), polytetrafluoroethylene, or other fluoropolymers. The second outer layer 13c can be made of a combination of polymers with the same hardness or different hardnesses, such as made of polyamide, nylon, or a blend or splice of polyamide and nylon. In this embodiment, the distal end tube 13 and the inner lumen tube 12 can be separately prepared and then connected, or the distal end tube 13 and the inner lumen tube 12 can also be integrally provided.

[0060] In this embodiment, the first support layer 12b is composed of wire. The first support layer 12b is used to support the inner lumen tube 12 to improve the strength of the inner lumen tube 12 to resist the pressure during balloon inflation, ensuring that the inner lumen tube 12 will not deform and clamp the guide wire. The first support layer 12b and the first inner layer 12a or the first outer layer 12c can be combined by means of hot pressing or bonding. At least one first groove 12b1 is provided on at least one surface of the first support layer 12b. When the first support layer 12b is combined with other layers, the contact area between the first support layer 12b and other layers can be increased, and at the same time, the relative displacement in the axial direction between the first support layer 12b and the first inner layer 12a or the first outer layer 12c is restricted, thereby significantly improving the bonding strength between two or more layers, avoiding the delamination phenomenon of the inner lumen tube 12 during the use of the balloon catheter, and more effectively ensuring that the inner lumen tube 12 supports the balloon inflation while the inner lumen of the inner lumen tube 12 itself does not deform, that is, the inner lumen tube 12 will not clamp the guide wire and cause the balloon catheter to be unable to track the guide wire for delivery. The first support layer 12b and the first inner layer 12a or the first outer layer 12c are preferably combined by hot pressing. By heating, the material of the first inner layer 12a or the first outer layer 12c undergoes a certain melting deformation and partially embeds into the first groove 12b1, further increasing the bonding area and enhancing the limiting effect, and further improving the bonding strength between the first support layer 12b and the first inner layer 12a or the first outer layer 12c.

[0061] As Figure 3 shown, in this embodiment, the wire in the first support layer 12b is formed by helical winding, that is, the first support layer 12b is formed by helically winding the wire to form a spring structure. Figure 3The S direction represents the axial direction of the first support layer 12b, which is consistent with the axial direction of the inner cavity tube 12, and the D direction represents the radial direction of the first support layer 12b, which is consistent with the radial direction of the inner cavity tube 12. Specifically, the first support layer 12b can be formed by helically winding a complete wire to obtain a spring structure, or can be formed by helically winding multiple wires. The multiple wires are preferably arranged in parallel or nested with each other, or can be arranged in a head-to-tail connection along the axis. In this embodiment, the first grooves 12b1 are distributed on the surface of the wire and extend along the extension direction of the wire. Since there is a certain torsion during the helical winding of the wire, in the first support layer 12b of the formed spring structure, some of the first grooves 12b1 are distributed on the outer peripheral surface of the spring structure, and at the same time, some of the first grooves 12b1 are distributed on the inner side surface of the spring structure. On the bonding surface between the first support layer 12b and the first inner layer 12a and the first outer layer 12c, along the entire extension direction of the wire, the area of the bonding surface is enhanced, that is, the bonding contact area between the first support layer 12b and the first inner layer 12a and the first outer layer 12c can be maximized.

[0062] The wire forming the first support layer 12b can be a flat wire or a round wire. The first grooves 12b1 can be formed on the surface of the wire by laser, drawing, sandblasting and / or other means. In the cross-section of the first support layer 12b, the shape of the first grooves 12b1 can be a fan-shaped groove, an arc-shaped groove or a polygonal groove. The fan-shaped groove is, for example, a V-shaped groove, the arc-shaped groove can be, for example, a U-shaped groove, a circular groove or an elliptical groove, and the polygonal groove can be, for example, a trapezoidal groove, a rectangular groove, etc. Here, the cross-section of the first support layer 12b is a cross-sectional plane along the axis direction S of the first support layer 12b.

[0063] In this embodiment, when the wire material forming the first support layer 12b is a flat wire material, the width of the wire material can be selected from 0.0005 inches to 0.006 inches, preferably from 0.0005 inches to 0.003 inches. The thickness of the wire material can be selected from 0.0005 inches to 0.006 inches, preferably from 0.0005 inches to 0.003 inches. When the wire material is a round wire material, the diameter of the wire material can be selected from 0.0005 inches to 0.006 inches, and preferably from 0.0005 inches to 0.003 inches. In this embodiment, the width of the first groove 12b1 can be selected from 3 μm to 80 μm, and preferably from 3 μm to 40 μm, and the depth of the first groove 12b1 can be selected from 3 nm to 30 μm. In this embodiment, by reasonably designing the dimensions of the wire material and the first groove 12b1, on the one hand, the support strength of the first support layer 12b for the inner cavity tube 12 itself can be ensured, and deformation under pressure during the inflation of the balloon body 11 can be avoided. On the other hand, the bonding contact area between the first support layer 12b and other layers can be increased as much as possible, and delamination during the inflation of the balloon body 11 can be avoided. Here, the width refers to the dimension along Figure 3 the S direction in Figure 3 and the thickness of the wire material refers to the dimension along Figure 3 the D direction in

[0064] and the depth of the first groove 12b1 refers to the dimension along the D direction in. The width and thickness of the wire material and the width and depth of the first groove 12b1 described here are all examples. In other alternative embodiments, the width and thickness of the wire material and the width and depth of the first groove 12b1 can adopt the values within the numerical ranges listed here, or can adopt values outside the numerical ranges listed here, and all belong to the protection scope of the present invention.

[0064] In this embodiment, the ratio of the width of the first groove 12b1 to the width of the wire material forming the first support layer 12b can be selected to be greater than 0 and less than or equal to 1 / 2, such as 1 / 3, 1 / 4, 2 / 5, 3 / 8, 1 / 2, etc. The ratio of the depth of the first groove 12b1 to the thickness of the wire material can be selected to be greater than 0 and less than or equal to 1 / 2, such as 1 / 3, 1 / 4, 2 / 5, 3 / 8, 1 / 2, etc. By reasonably designing the ratio of the width of the first groove 12b1 to the width of the wire material, it is avoided that the support strength of the first support layer 12b is affected due to the over-large design of the first groove 12b1, and it is also avoided that the first groove 12b1 is too small to play a good role in increasing the bonding contact area between the first support layer 12b and other layers. However, the present invention is not limited thereto. In other alternative embodiments, the ratio of the width of the first groove 12b1 to the width of the wire material can also be other values, such as 3 / 5, 5 / 9, etc., and the ratio of the depth of the first groove 12b1 to the thickness of the wire material can also be other values, such as 3 / 5, 5 / 9, etc., which are all within the protection scope of the present invention.

[0065] The first support layer 12b of the present invention is not limited to Figure 3 the structure shown in. In another alternative embodiment, the first groove can be provided only on the inner surface of the spring structure, that is, the surface of the spring structure facing the first inner layer 12a. In another alternative embodiment, the first groove can also be provided only on the outer peripheral surface of the spring structure, that is, the surface of the spring structure facing the first outer layer 12c. In yet another alternative embodiment, the wire material can be formed by cross-weaving, and the first support layer 12b can be a woven structure formed by weaving the wire material. The first groove can extend along the extension direction of the wire material. In still another alternative embodiment, the first groove can include a plurality of pits distributed on the surface of the wire material forming the first support layer 12b, and the plurality of pits are spaced apart on the surface of the wire material. Optionally, the pits are uniformly arranged along the extension direction of the wire material. When the pits are relatively small, more than one row of pits can be provided on the wire material. In other alternative embodiments, the wire material forming the first support layer 12b can also adopt a combination of two structures of spiral winding and cross-weaving, or other forming methods or combination methods of non-spiral winding and / or non-weaving.

[0066] Such as Figure 2As shown, in this embodiment, the wire material forming the first support layer 12b is a developable wire material. The developable effect of the balloon catheter is achieved through the first support layer 12b, which can replace the structure of adding a rigid developable metal ring with a certain wall thickness and length on the outer surface of the inner lumen tube 12 in the traditional developable method. While ensuring that the effective working length of the balloon body 11 is reflected by the developability of the inner lumen tube 12, the diameter of the inner lumen tube 12 is not increased, thereby reducing the passing outer diameter of the balloon catheter and providing the ability of the balloon catheter to reach the distal intracranial blood vessels. Specifically, the wire material can be a metal wire material. In this embodiment, the formation of a metal spring structure by helically winding the wire material or a metal braided structure by cross-weaving is taken as an example for illustration. The metal spring structure or the metal braided structure has better supportability than using a polymer layer. And the metal spring structure can improve the flexibility of the inner lumen tube 12 while ensuring the compressive resistance of the inner lumen tube 12, enabling the balloon catheter to more easily pass through the tortuous and complex diseased blood vessels in the distal intracranial region, reducing the pushing resistance, and improving the passability and deliverability of the balloon catheter. More preferably, the first support layer 12b in this embodiment adopts a metal spring structure to further enhance the flexibility of the inner lumen tube 12, making it easier to conform to the shape of the blood vessel, and thus being able to reach more distal tortuous and complex diseased positions.

[0067] In this embodiment, the metal preferably used for the metal wire material forming the first support layer 12b is a platinum alloy such as platinum iridium / platinum nickel / platinum tungsten, or an alloy such as tungsten or tantalum, or a metal material with good developable effect such as gold. However, the present invention is not limited to the metal materials listed here. In other alternative embodiments, metal materials other than those listed here can also be used. The metal wire material forming the first support layer 12b can also adopt a drawn filled tubing (DFT), such as a wire material containing a developable metal such as platinum or tantalum inside nickel-titanium. In another alternative embodiment, the wire material can also be a polymer wire material doped with a developer. For example, the wire material can be a polyamide or nylon wire material doped with a developer, and the developer can be a barium salt, a bismuth salt, a tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc.

[0068] In this embodiment, the second support layer 13b of the end tube 13 may adopt a structure similar to that of the first support layer 13a. Specifically, the second support layer 13b is composed of wire materials and is used to support the end tube 13 to improve the strength of the end tube 13 to resist external pressure during use and ensure that the end tube 13 will not be deformed. The second support layer 13b and the second inner layer 13a or the second outer layer 13c can be combined by hot pressing, bonding or other means. At least one second groove is provided on at least one surface of the second support layer 13b. When the second support layer 13b is combined with other layers, the contact area between the second support layer 13b and other layers can be increased, and at the same time, the relative displacement in the axial direction between the second support layer 13b and the second inner layer 13a or the second outer layer 13c is restricted, thereby significantly improving the bonding strength between two or more layers and avoiding the delamination of the end tube 13 during use, which may affect the pushing performance. Preferably, the second support layer 13b and the second inner layer 13a or the second outer layer 13c are combined by hot pressing. By heating, the material of the second inner layer 13a or the second outer layer 13c undergoes a certain amount of melting deformation and partially embeds into the second groove, further increasing the bonding area and enhancing the limiting effect, and further improving the bonding strength between the second support layer 13b and the second inner layer 13a or the second outer layer 13c.

[0069] In this embodiment, the second support layer 13b is a spring structure formed by spiral winding or a braided structure formed by cross weaving, or a combination of a spring structure and a braided structure. Preferably, the second support layer 13b is a spring structure, which is formed by spiral winding a complete wire material or by spiral winding multiple wire materials. The second grooves can be all distributed on the outer peripheral surface of the spring structure of the second support layer 13b, all distributed on the inner surface of the spring structure, or part of them are distributed on the outer peripheral surface of the spring structure and part of them are distributed on the inner surface of the spring structure. On the bonding surface between the second support layer 13b and the second inner layer 13a and the second outer layer 13c, along the entire extension direction of the wire material, the area of the bonding surface is enhanced, that is, the bonding strength between the second support layer 13b and the second inner layer 13a and the second outer layer 13c can be maximized.

[0070] Similarly, the wire for forming the second support layer 13b can be a flat wire or a round wire. The second groove can be formed on the surface of the wire by laser, drawing, sandblasting, and / or other means. In the cross-section of the second support layer 13b, the shape of the second groove can be a fan-shaped groove, an arc-shaped groove, or a polygonal groove. The fan-shaped groove is, for example, a V-shaped groove. The arc-shaped groove can be, for example, a U-shaped groove, a circular groove, or an elliptical groove. The polygonal groove can be, for example, a trapezoidal groove, a rectangular groove, etc. The shape and size of the wire for forming the second support layer 13b (the width and thickness of the flat wire or the diameter of the round wire), and the size of the groove (width and depth) can be the same as those of the wire for forming the first support layer 12b, or different from those of the wire for forming the first support layer 12b. For example, when the wire for forming the second support layer 12b is a flat wire, the width of the wire can be selected from 0.0005 inches to 0.006 inches, preferably 0.0005 inches to 0.003 inches. The thickness of the wire can be selected from 0.0005 inches to 0.006 inches, preferably 0.0005 inches to 0.003 inches. When the wire is a round wire, the diameter of the wire can be selected from 0.0005 inches to 0.006 inches, and preferably 0.0005 inches to 0.003 inches. In this embodiment, the width of the second groove can be selected from 3 μm to 80 μm, and preferably 3 μm to 40 μm. The depth of the second groove can be selected from 3 nm to 30 μm. In this embodiment, by reasonably designing the size of the wire and the size of the second groove, on the one hand, the support strength of the second support layer 13b for the end tube 13 itself can be ensured, and deformation under pressure during use can be avoided. On the other hand, the bonding contact area between the second support layer 13b and other layers can be increased as much as possible, and delamination and folding phenomena during use can be avoided.

[0071] In this embodiment, the ratio of the width of the second groove to the width of the wire forming the second support layer 13b can be selected to be greater than 0 and less than or equal to 1 / 2, such as 1 / 3, 1 / 4, 2 / 5, 3 / 8, 1 / 2, etc. The ratio of the depth of the second groove to the thickness of the wire can be selected to be greater than 0 and less than or equal to 1 / 2, such as 1 / 3, 1 / 4, 2 / 5, 3 / 8, 1 / 2, etc. By reasonably designing the ratio of the width of the second groove to the width of the wire, it is avoided that the support strength of the second support layer 13b is affected due to the over-large design of the second groove, and it is also avoided that the second groove is too small to play a good role in increasing the bonding contact area between the second support layer 13b and other layers. However, the present invention is not limited thereto. In other alternative embodiments, the ratio of the width of the second groove to the width of the wire can also be other values, such as 3 / 5, 5 / 9, etc., and the ratio of the depth of the second groove to the thickness of the wire can also be other values, such as 3 / 5, 5 / 9, etc., which all fall within the protection scope of the present invention.

[0072] In another alternative embodiment, the second groove may include a plurality of pits distributed on the surface of the wire forming the second support layer 13b, and the plurality of pits are spaced apart on the surface of the wire. Optionally, the pits are arranged uniformly along the extending direction of the wire. When the pits are relatively small, more than one row of pits can be provided on the wire. In other alternative embodiments, the wire forming the second support layer 13b can also adopt other constitutive or combined ways of non-spiral winding and / or non-weaving.

[0073] In this embodiment, the wire forming the second support layer 13b is a developable wire, and the imaging effect of the balloon catheter is realized through the second support layer 13b. Specifically, the wire can be a metal wire. In this embodiment, the case where the wire is helically wound to form a metal spring structure or cross-woven to form a metal braided structure is taken as an example for description. The metal spring structure or the metal braided structure has better supportability than the polymer layer. And the metal spring structure or the metal braided structure can improve the flexibility of the distal tube 13 while ensuring the compressive resistance of the distal tube 13, so that the balloon catheter can more easily pass through the intracranial distal tortuous and complex diseased blood vessels, reduce the pushing resistance, and improve the passability and deliverability of the balloon catheter. More preferably, the second support layer 13b in this embodiment adopts a metal spring structure to further improve the flexibility of the distal tube 13, and it is easier to conform to the shape of the blood vessel, so as to reach a more distal tortuous and complex diseased position.

[0074] In this embodiment, the metal wire used to form the second support layer 13b is preferably a platinum alloy such as platinum iridium / platinum nickel / platinum tungsten, or an alloy such as tungsten or tantalum, or a metal material with good development effect such as gold. However, the present invention is not limited to the metal materials listed here. In other alternative embodiments, metal materials other than those listed here can also be used. The metal wire used to form the second support layer 13b can also be a Drawn Filled Tubing (DFT), such as a wire containing a metal such as platinum or tantalum inside nickel-titanium. In another alternative embodiment, the wire can also be a polymer wire doped with a developer. For example, the wire can be a polyamide or nylon wire doped with a developer, and the developer can be a barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc.

[0075] As Figure 1 shown, the balloon body 11 includes a straight section 111 and a first transition section 112 located on the distal side of the straight section 111. The first transition section 112 has a tapered structure from the proximal end to the distal end, and the straight section 111 of the balloon body 11 is the effective working part of the balloon body 11. The inner lumen tube 12 includes a first region 121 corresponding to the straight section 111 and a second region 122 corresponding to the first transition section 112. The density of the wires of the first support layer 12b in the first region 121 is different from the density of the wires of the first support layer 12b in the second region 122. Thus, the balloon catheter can better develop the effective working part of the balloon body 11, and has better imaging recognition than a single metal imaging ring in the prior art or adding two imaging rings only at the outer surface positions of the inner lumen tube 12 corresponding to both ends of the straight section 111 of the balloon body 11, which is more conducive to doctors observing the position of the balloon. Here, the density of the wires refers to the degree of tightness of the wire arrangement, which can be expressed as the number of wires per unit length or unit area or the space occupancy of the wires.

[0076] In this embodiment, as Figure 1 shown, the balloon body 11 further includes a second transition section 113 located on the proximal side of the straight section 111, and the second transition section 113 has a tapered structure from the distal end to the proximal end. As Figure 1 and Figure 2 shown, the inner lumen tube 12 further includes a third region 123 corresponding to the second transition section 113, and the structure of the third region 123 can be the same as or different from the structure of the first region. In other alternative embodiments, the balloon body 11 includes one of the first transition section 112 or the second transition section 113, or the balloon body 11 only has the straight section 111.

[0077] As Figure 2As shown, in this embodiment, the density of the wire in the first support layer 12b at the first region 121 is greater than the density of the wire in the first support layer 12b at the second region 122. Here, the density of the first support layer 12b is expressed in PPI (the number of spirals or braiding nodes per unit inch). That is, the PPI of the first support layer 12b at the first region 121 is greater than the PPI of the first support layer 12b at the second region 122. For example, the density of the wire in the first support layer 12b at the first region 121 can be selected as 500 - 800 spirals or braiding nodes per unit inch, and the density of the wire in the first support layer 12b at the second region 122 can be selected as 200 - 300 spirals or braiding nodes per unit inch. By adopting a higher-density spiral winding or braiding method to form the first support layer 12b in the inner cavity tube 12 corresponding to the effective working part of the balloon body 11, the strength and compressive resistance of this part of the inner cavity tube 12 can be improved, further ensuring that the inner cavity tube will not deform and hold the guide wire tightly.

[0078] As Figure 2 shown, the density of the wire in the second support layer 13b of the end tube 13 is different from the density of the wire in the first support layer 12b at the second region 122. To distinguish the position of the end tube 13 and the position of the inner cavity tube 12 during fluoroscopy. In this embodiment, the PPI of the second support layer 13b of the end tube 13 is between the PPI of the first support layer 12b at the first region 121 and the PPI of the second region 122 of the inner cavity tube 12; or, the PPI of the second support layer 13b of the end tube 13 is the same as the PPI of the first support layer 12b at the first region 121.

[0079] Therefore, in this embodiment, the radiopacity of the first region 121 of the inner cavity tube 12 corresponding to the straight section 111 of the balloon body 11 is equal to or stronger than the radiopacity of the end tube 13, while the radiopacity of the second region 122 of the inner cavity tube 12 is weaker than the radiopacity of the first region 121 and the end tube 13. On the one hand, the radiopacity of the end tube 13 enables the doctor to visualize the tip under X-ray conditions during the operation and can let the doctor directly know the length of the end tube 13 of the balloon catheter during the operation, facilitating the doctor to adjust the position and direction of the end tube 13 according to the vascular conditions or the pushing state during the operation, improving the safety of the balloon catheter during release; on the other hand, by the radiopacity of the part of the inner cavity tube 12 corresponding to the straight section 111 of the balloon body 11 being equal to or stronger than the radiopacity of the end tube 13, while the radiopacity of the second region 122 of the inner cavity tube 12 is weaker than the radiopacity of the first region 121 and the end tube 13, it is convenient for the doctor to identify the effective working length of the balloon body 11.

[0080] As Figure 4As shown, it is a cross-sectional view of the distal end and the end tube of the inner lumen tube 12 in the balloon catheter according to the second embodiment of the present invention. In the second embodiment, the basic structural components of the balloon catheter are the same as those of the balloon catheter 10 shown in Figure 1 . The main difference between the second embodiment and the first embodiment is that the first outer layer 12c of the inner lumen tube 12 is doped with a radiopaque agent. Specifically, the first outer layer 12c of the inner lumen tube 12 is a polyamide or nylon tube doped with a radiopaque agent, and the radiopaque agent can be barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc. Specifically, the radiopaque agent can be added to its raw materials during the extrusion process of preparing the first outer layer 12c to obtain a polymer layer doped with a radiopaque agent. By adding a radiopaque agent to the first outer layer 12c, the imaging effect of the inner lumen tube 12 can be further improved.

[0081] Preferably, the part of the first outer layer 12c corresponding to the straight section 111 of the balloon (i.e., located in the first region 121 of the inner lumen tube 12) is doped with a radiopaque agent. At the same time, the PPI of the first support layer 12b at the first region 121 is greater than the PPI of the first support layer 12b at the second region 122. The PPI of the second support layer 13b of the end tube 13 is between the PPI of the first support layer 12b at the first region 121 and the PPI of the first support layer 12b at the second region 122. Or the PPI of the second support layer 13b of the end tube 13 is the same as the PPI of the first support layer 12b at the first region 121. Thus, the part of the inner lumen tube 12 corresponding to the straight section 111 of the balloon body 11 has more prominent imaging properties than other parts, facilitating doctors to observe the position of the effective working part of the balloon body 11. Preferably, the second outer layer 13c of the end tube 13 is also doped with a radiopaque agent. The second outer layer 13c of the end tube 13 is a polyamide or nylon tube doped with a radiopaque agent, and the radiopaque agent can be barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc.

[0082] Therefore, in this embodiment, the visibility of the second outer layer 13c of the distal tube 13 and the first outer layer 12c of the first region 121 of the inner lumen tube 12 is further increased. Moreover, the visibility of the first outer layer 12c of the first region 121 of the inner lumen tube 12 corresponding to the straight section 111 of the balloon body 11 can be equal to or stronger than that of the second outer layer 13c of the distal tube. The visibility of the first outer layer 12c of the second region 122 of the inner lumen tube 12 is weaker than that of the first outer layer 12c of the first region 121 and the second outer layer 13c of the distal tube 13. In this way, the distinction in visibility between the overall second region 122 and the overall first region 121 and the overall distal tube 13 is greater, making it more intuitive for doctors to observe. On the one hand, the visibility of the distal tube 13 enables doctors to achieve head - end visibility under X - ray conditions during the operation and allows doctors to intuitively know the length of the distal tube 13 of the balloon catheter during the operation, facilitating doctors to adjust the position and direction of the distal tube 13 according to the vascular conditions or the pushing state during the operation, thus improving the safety of the balloon catheter during release. On the other hand, by having the overall visibility of the first region 121 equal to or stronger than the overall visibility of the distal tube 13, and the overall visibility of the second region 122 of the inner lumen tube 12 being weaker than the overall visibility of the first region 121 and the overall visibility of the distal tube 13, it is convenient for doctors to identify the effective working length of the balloon body 11.

[0083] In another alternative embodiment, in the inner lumen tube 12, a developer can also be doped in the first inner layer 12a, or a developer can be doped in both the first outer layer 12c and the first inner layer 12a. In the distal tube 13, a developer can also be doped in the second inner layer 13a, or a developer can be doped in both the second outer layer 13c and the second inner layer 13a. In yet another alternative embodiment, the entire first outer layer 12c can be doped with a developer, and the entire second outer layer 13c can be doped with a developer. In still another alternative embodiment, only the part of the first outer layer 12c located in the first region 121 and the second outer layer 13c can be doped with a developer, while the PPI of the entire first support layer 12b remains consistent.

[0084] As Figure 5 shown, it is a cross - sectional view of the distal end of the inner lumen tube 12 and the distal tube in the balloon catheter of the third embodiment of the present invention. In the third embodiment, the basic structural components of the balloon catheter are the same as Figure 1The structural components of the balloon catheter 10 shown are the same. The main difference between the third embodiment and the first embodiment is that: the distal tube 13 only includes the structure of the second outer layer 13c and the second inner layer 13a, without the second support layer. The thickness of the second outer layer 13c at the position of the distal tube 13 can be increased, or the thickness of the second inner layer 13a can be increased, so that the inner diameter and outer diameter of the distal tube 13 are both consistent with the inner diameter and outer diameter of the inner lumen tube 12. In other alternative embodiments, the inner diameter and / or outer diameter of the distal tube 13 is not consistent with the inner diameter and / or outer diameter of the inner lumen tube 12. Preferably, the outer diameter of the distal tube 13 is tapered from the proximal end to the distal end, the outer diameter of the proximal end of the distal tube 13 is the same as the outer diameter of the inner lumen tube 12, and the outer diameter of the distal end of the distal tube 13 is smaller than the outer diameter of the inner lumen tube 12. For example, a certain taper is formed by laser at the farthest end of the distal tube 13 to further improve the trackability, pushability and passability of the balloon catheter.

[0085] In the third embodiment, the first outer layer 12c of the inner lumen tube 12 and / or the second outer layer 13c of the distal tube 13 is a polymer layer partially doped with a contrast agent. In another alternative embodiment, the first outer layer 12c of the inner lumen tube 12 or the second outer layer 13c of the distal tube 13 can also be made of a polymer layer without doping a contrast agent as shown in the first embodiment Figure 2 shown.

[0086] As Figure 6 shown, it is a cross-sectional view of the distal end of the inner lumen tube 12 and the distal tube in the balloon catheter of the fourth embodiment of the present invention. In the fourth embodiment, the basic structural components of the balloon catheter are the same as those of the balloon catheter 10 shown in Figure 1 The main difference between the fourth embodiment and the first embodiment is that: the density of the wires of the first support layer 12b at the first region 121 is also unevenly distributed.

[0087] Specifically, the first region 121 includes a central region, an end region, and a connection region located between the central region and the end region. The PPI of the first support layer 12b corresponding to the connection region is different from the PPI of the first support layer 12b corresponding to the central region and the end region, so as to mark the position of the middle part of the balloon body 11 by different contrast properties, which is convenient for doctors to judge the two ends of the effective working part of the balloon body 11 and can also judge the position of the middle part at the same time. Here, the lengths of the central region and the end region of the straight section 111 along the axial direction of the inner lumen tube 12 can be set as required. Preferably, the PPI of the first support layer 12b corresponding to the connection region is less than the PPI of the first support layer 12b corresponding to the central region and the end region, which better meets the needs of clinicians for observing the working section and the center point position of the balloon body 11.

[0088] In the fourth embodiment, the structure of the distal tube 13 is the same as that of the third embodiment shown in Figure 5 . In another alternative embodiment, the structure of the distal tube 13 can also adopt the structure of the first embodiment shown in Figure 2 , and the PPI of the second support layer 13b at the position of the distal tube 13 can be selected as required.

[0089] In the fourth embodiment, the first outer layer 12c of the inner lumen tube 12 and / or the second outer layer 13c of the distal tube 13 are polymer layers doped with a developer. In another alternative embodiment, the first outer layer 12c of the inner lumen tube 12 or the second outer layer 13c of the distal tube 13 can also adopt the polymer layer without a developer doped as shown in Figure 2 the first embodiment.

[0090] As shown in Figure 7 , it is a cross-sectional view of the distal end of the inner lumen tube 12 and the distal tube in the balloon catheter of the fifth embodiment of the present invention. In the fifth embodiment, the basic structural components of the balloon catheter are the same as those of the balloon catheter 10 shown in Figure 1 . The main difference between the fifth embodiment and the first embodiment is that: the density of the wire in the first support layer 12b at the third region 123 is the same as the density of the wire in the first support layer 12b at the first region 121.

[0091] Specifically, the part of the inner lumen tube 12 corresponding to the second transition section 113 of the balloon body 11 is the third region 123. The PPI of the first support layer 12b at the third region 123 is the same as the PPI at the second region 122. In this embodiment, the PPI of the support layer 12b at the first region 121 and the second region 122 can be set in any one of the above-mentioned first embodiment to the sixth embodiment. The first outer layer 12c or the first inner layer 12a in this embodiment can be a polymer layer without a developer doped, a polymer layer doped with a developer as a whole, or a polymer layer with only the part corresponding to the first region 121 doped with a developer. In this embodiment, the distal tube 13 can be a three-layer structure having a second outer layer 13c, a second support layer 13b, and a second inner layer 13a, or can be a two-layer structure having only a second outer layer 13c and a second inner layer 13a. The second outer layer 13c or the second inner layer 13a can be a polymer layer without a developer doped, a polymer layer doped with a developer as a whole, or a polymer layer with a part doped with a developer.

[0092] As shown in Figure 8As shown, it is a cross-sectional view of the distal end and the terminal tube of the inner lumen tube 12 in the balloon catheter according to the sixth embodiment of the present invention. Compared with the sixth embodiment Figure 6 In the fourth embodiment shown, it is further provided that the PPI of the first support layer 12b corresponding to the third region 123 is the same as the PPI corresponding to the second region 122.

[0093] As Figure 9 shown, it is a cross-sectional view of the distal end and the terminal tube of the inner lumen tube 12 in the balloon catheter according to the seventh embodiment of the present invention. The difference between the seventh embodiment and the Figure 8 balloon catheter 10 of the sixth embodiment shown is that: the terminal tube 13 is a three-layer structure including a second outer layer 13c, a second inner layer 13a, and a second support layer 13b.

[0094] As Figure 10 shown, it is a cross-sectional view of the distal end and the terminal tube of the inner lumen tube 12 in the balloon catheter according to the eighth embodiment of the present invention. In the eighth embodiment, the basic structural components of the balloon catheter are the same as those of the Figure 1 balloon catheter 10 shown. The difference between the eighth embodiment and the first embodiment is that: the inner lumen tube 12 only includes a first support layer 12b and a first outer layer 12c located outside the first support layer 12b. The structure of the first support layer 12b in this embodiment can adopt the structure of the first support layer 12b in any one of the above-mentioned first to seventh embodiments. The first outer layer 12c in this embodiment can be a polymer layer without doping with a contrast agent, a polymer layer doped with a contrast agent as a whole, or a polymer layer with only the part corresponding to the first region 121 doped with a contrast agent. The terminal tube 13 in this embodiment can also be a structure including a second outer layer 13c and a second support layer 13b, or can be a single-layer structure only including the second outer layer 13c. The second support layer 13b can adopt the structure of the second support layer 13b in any one of the above-mentioned first to seventh embodiments. The second outer layer 13c can be a polymer layer without doping with a contrast agent, a polymer layer doped with a contrast agent as a whole, or a polymer layer partially doped with a contrast agent.

[0095] As Figure 11 shown, it is a cross-sectional view of the distal end and the terminal tube of the inner lumen tube 12 in the balloon catheter according to the ninth embodiment of the present invention. In the ninth embodiment, the basic structural components of the balloon catheter are the same as those of the Figure 1The structural components of the balloon catheter 10 shown are the same. The difference between the ninth embodiment and the first embodiment is that: the inner lumen tube 12 only includes a first support layer 12b and a first inner layer 12a located inside the first support layer 12b. The structure of the first support layer 12b in this embodiment can adopt the structure of the first support layer 12b in any one of the above-mentioned first to eighth embodiments. The first inner layer 12a in this embodiment can be a polymer layer not doped with a contrast agent, a polymer layer doped with a contrast agent as a whole, or a polymer layer with only the part corresponding to the first region 121 doped with a contrast agent. The distal end tube 13 in this embodiment can also be a structure that only includes a second inner layer 13a and a second support layer 13b, or can be a single-layer structure that only includes a second inner layer 13a. The second support layer 13b can adopt the structure of the second support layer 13b in any one of the above-mentioned first to eighth embodiments. The second inner layer 13a can be a polymer layer not doped with a contrast agent, a polymer layer doped with a contrast agent as a whole, or a polymer layer partially doped with a contrast agent.

[0096] As Figure 12 shown, it is a cross-sectional view of the distal end of the inner lumen tube 12 and the distal end tube in the balloon catheter of the tenth embodiment of the present invention. In the tenth embodiment, the basic structural components of the balloon catheter are the same as those of the Figure 1 balloon catheter 10 shown. The difference between the tenth embodiment and the first embodiment is that: the inner lumen tube 12 is a structure including a first inner layer 12a and a first outer layer 12c, the inner lumen tube 12 does not include a first support layer, and the distal end tube 13 is a structure including a second support layer 13b and a second outer layer 13c. The second outer layer 13c can adopt the structure of any one of the second outer layers 13c defined in the above-mentioned first to eighth embodiments. For example, the second outer layer 13c can be a polymer layer not doped with a contrast agent, a polymer layer doped with a contrast agent as a whole, or a polymer layer partially doped with a contrast agent. As Figure 13 shown, the second support layer 13b can adopt the structure of the first embodiment, preferably formed into a spring structure by helically winding wires, and at least one side surface (inner surface and / or outer surface) of the second support layer 13b is provided with a second groove 13b1. The shape and size of the wire and the shape and size of the second groove 13b1 can be the same as or different from those in the first embodiment. Since there is no second inner layer in this embodiment, preferably the outer surface of the second support layer 13b is provided with the second groove 13b1.

[0097] In another alternative embodiment, the inner cavity tube 12 may also have a structure including a first inner layer 12a and a first outer layer 12c, and the end tube 13 may have a structure including only a second inner layer 13a and a second support layer 13b. In yet another alternative embodiment, the inner cavity tube 12 may have a structure including a first inner layer 12a and a first outer layer 12c, and the end tube 13 may have a structure including a second inner layer 13a, a second outer layer 13c, and a second support layer 13b, and second grooves 13b1 may be provided on either the inner surface and / or the outer surface of the second support layer 13b. The second inner layer 13a may adopt the structure of the above-mentioned first embodiment, for example, a polymer layer without a developer doped therein, a polymer layer entirely doped with a developer, or a polymer layer partially doped with a developer. In still another alternative embodiment, the inner cavity tube 12 may have a structure including only the first inner layer 12a or the first outer layer 12c, and the end tube 13 may have a structure including a second support layer 13b and a second inner layer 13a and / or a second outer layer 13c.

[0098] As Figure 12 shown, in this embodiment, in order to improve the adhesion between the first inner layer 12a and the first outer layer 12c, a first bonding layer 12d may further be included between the first inner layer 12a and the first outer layer 12c of the inner cavity tube 12. The first bonding layer 12d may adopt a linear polymer material, such as low-density polyethylene. When preparing the inner cavity tube 12, a layer of the first bonding layer 12d may be added between the first inner layer 12a and the first outer layer 12c, and the three layers are extruded integrally. Since the inner cavity tube 12 lacks a support layer, in order to withstand the pressure during balloon inflation, it is necessary to greatly increase the strength and thickness of the first outer layer 12c, which may sacrifice the flexibility of the inner cavity tube 12 and the overall outer diameter of the balloon body 11.

[0099] In the above-mentioned first embodiment, second embodiment, fifth embodiment, seventh embodiment, eighth embodiment, ninth embodiment, and tenth embodiment, the PPI of the second support layer 13b of the end tube 13 may be uniformly distributed along the axial direction of the end tube 13, or may be non-uniformly distributed. For example, the PPI of the part of the second support layer 13b of the end tube 13 close to the inner cavity tube 12 is greater than the PPI of other parts of the second support layer 13b, or the PPI of the part of the second support layer 13b of the end tube 13 far from the inner cavity tube 12 is greater than the PPI of other parts of the second support layer 13b, etc. When adding a developer to the second outer layer 13c and / or the second inner layer 13a of the end tube 13, the developer may be uniformly distributed or non-uniformly distributed along the axial direction of the end tube 13.

[0100] In the above-described first to ninth embodiments, the inner cavity tube 12 may further include a first adhesive layer, and the first adhesive layer may be made of a linear polymer material, such as low-density polyethylene. The first adhesive layer may be disposed between the first inner layer 12a and the first support layer 12b, or between the first support layer 12b and the first outer layer 12c, or may be disposed between the first inner layer 12a and the first support layer 12b and between the first support layer 12b and the first outer layer 12c simultaneously.

[0101] In the above-described first to tenth embodiments, the end tube 13 may also further include a second adhesive layer, and the second adhesive layer may be made of a linear polymer material, such as low-density polyethylene. The second adhesive layer may be disposed between the second inner layer 13a and the second outer layer 13c, or between the second support layer 13b and the second inner layer 13a and / or the second outer layer 13c.

[0102] In the various drawings of the present invention, the thickness of each layer and the thickness relationship between different layers are only examples and do not serve as limitations between the present inventions. Specifically, the thickness of each layer can be selected and set as needed, and all fall within the protection scope of the present invention.

[0103] The above content is a further detailed description of the present invention in combination with specific preferred embodiments, and it cannot be determined that the specific implementation of the present invention is only limited to these descriptions. For those of ordinary skill in the technical field to which the present invention pertains, without departing from the concept of the present invention, several simple deductions or substitutions can be made, and all should be regarded as belonging to the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that, It includes a balloon body, an inner lumen tube, and a distal end tube. The inner lumen tube penetrates through the balloon body. The balloon body includes a straight section and a first transition section located on the distal side of the straight section. The inner lumen tube includes a first region corresponding to the straight section and a second region corresponding to the first transition section. The distal end tube is connected to the distal end of the balloon body and / or the distal end of the inner lumen tube. The inner lumen tube includes a support layer, or the inner lumen tube and the distal end tube include a support layer. The support layer is composed of radiopaque wires, and the density of the wires of the support layer in the first region is different from the density of the wires of the support layer in the second region. The inner lumen tube further includes an inner layer located inside the support layer and / or an outer layer located outside the support layer, or the inner lumen tube and the distal end tube further include an inner layer located inside the support layer and / or an outer layer located outside the support layer. At least one groove is provided on at least one surface of the support layer.

2. The balloon catheter according to claim 1, characterized in that, The balloon catheter further includes an outer tube. The proximal end of the balloon body is fixed to the outer tube. The support layer is formed by helically winding the wires into a spring structure, or the support layer is formed by cross-weaving the wires into a braided structure, or the support layer includes a combination of a helically wound spring structure and a cross-woven braided structure.

3. The balloon catheter according to claim 1, characterized in that, The groove extends along the extension direction of the wire, or the groove includes a plurality of pits distributed on the surface of the wire.

4. The balloon catheter according to claim 1, wherein, The width of the wire is 0.0005 inches to 0.006 inches, and / or the thickness of the wire is 0.0005 inches to 0.006 inches. The width of the groove is 3 μm to 80 μm, and / or the depth of the groove is 3 nm to 30 μm.

5. The balloon catheter according to claim 1, characterized in that, The ratio of the width of the groove to the width of the wire is greater than 0 and less than or equal to 1 / 2, and / or the ratio of the depth of the groove to the thickness of the wire is greater than 0 and less than or equal to 1 / 2.

6. The balloon catheter according to claim 1, wherein The radiopaque wire is a metal wire or a polymer wire doped with a radiopaque agent.

7. The balloon catheter according to claim 2, wherein, The density of the wires of the support layer in the first region is 500 to 800 helical or braided nodes per unit inch, and the density of the wires of the support layer in the second region is 200 to 300 helical or braided nodes per unit inch.

8. The balloon catheter according to claim 1, characterized in that, Both the inner lumen tube and the distal end tube include the support layer, and the density of the wires of the support layer at the distal end tube is different from the density of the wires of the support layer in the second region.

9. The balloon catheter according to claim 8, characterized in that, The density of the wires of the support layer at the distal end tube is between the density of the wires of the support layer in the first region and the density of the wires of the support layer in the second region of the inner lumen tube, or the density of the wires of the support layer at the distal end tube is the same as the density of the wires of the support layer in the first region.

10. The balloon catheter according to claim 1, characterized in that, The first region includes a central region, an end region, and a connection region located between the central region and the end region. The density of the wires of the support layer in the connection region is different from the density of the wires of the support layer in the central region and the end region.

11. The balloon catheter according to claim 1, characterized in that, The inner layer and / or the outer layer is a polymer layer doped with a developer at least in part.

12. The balloon catheter according to claim 11, characterized in that, The part of the inner layer and / or the outer layer corresponding to the straight section of the balloon is doped with a developer, and / or the part of the inner layer and / or the outer layer corresponding to the terminal tube is doped with a developer.

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