CN113244505B - Balloon catheter - Google Patents

Abstract

The invention provides a balloon catheter which comprises a balloon body, an inner cavity tube and an end tube, wherein the inner cavity tube penetrates through the balloon body, the end tube is connected with the distal end of the balloon body and/or the distal end of the inner cavity tube, the inner cavity tube and/or the end tube comprises a supporting layer, the supporting layer is composed of wires, the inner cavity tube and/or the end tube further comprises an inner layer positioned on the inner side of the supporting layer and/or an outer layer positioned on the outer side of the supporting layer, and at least one groove is formed in the surface of at least one side of the supporting layer. According to the invention, the supporting layer is added in the inner cavity tube and/or the tail end tube to ensure that the inner cavity tube and/or the tail end tube cannot deform to hold the guide wire tightly, and the grooves are arranged on the surface of the supporting layer to improve the bonding contact area between the supporting layer and other layers of the inner cavity tube, so that the bonding strength between two or more layers is improved, and the layering phenomenon in the using process is avoided.

Description

Balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter.

Background

Ischemic stroke is mainly caused by vascular stenosis, occlusion/hemodynamics or blood composition change, and causes insufficient oxygen carrying and nutrient substances or reduced metabolite clearance capacity of blood, and death of neurons/glia cells and blood vessels of the brain accounts for about 80% of cerebrovascular diseases, and cerebral vascular stenosis is an important causative factor and risk factor for ischemic cerebrovascular diseases. The main treatment methods currently used for treating cerebral vascular stenosis are:

(i) The treatment of medicaments, combined with medicaments for resisting platelet aggregation/reducing blood fat and the like, delays the progress of carotid artery stenosis and improves the cerebrovascular reactivity;

(ii) Intracranial bypass, for symptomatic intracranial stenosis patients with severe hemodynamic disorders, the intracranial bypass may improve brain histology/reduce stroke recurrence rate;

(iii) Endovascular treatment, in which for symptomatic intracranial stenosis with optimal drug inefficiency or cerebral collateral circulation decompensation not less than 70%, the stenosed vessel is dilated by balloon angioplasty or stent implantation, so as to restore vascular access. The common intracranial stenosis blood vessel is more complicated in tortuosity, the diameter of the blood vessel is small, and the stenosis part is positioned at the far end of the blood vessel such as the C6-C7 position, the M1-M2 position and the like, so that the balloon catheter is required to have good trafficability and arrival capability for balloon angioplasty so that a doctor can smoothly convey the balloon catheter to a lesion position, in addition, the balloon catheter can be developed to be an important functional index, and the doctor can accurately position the balloon position through balloon development so as to ensure the accurate performance of balloon dilatation.

At present, as the balloon catheter is filled to a certain pressure to dilate the stenosis during treatment, the inner cavity tube needs to have a certain strength to resist the pressure during balloon filling, so that the inner cavity tube is ensured not to deform to hug the guide wire, and the balloon catheter cannot track the guide wire. While the common inner cavity tube is composed of multiple layers of materials, layering can occur when the balloon is inflated, and if layering occurs, the strength of the inner cavity tube can be reduced. In addition, the intracranial balloon catheter is characterized in that one or two metal rings are arranged on the outer wall of the inner tube to realize the balloon developing function and indicate the working length of the balloon. On the premise of meeting the development requirement, the metal ring needs to have a certain wall thickness and length, and can become the part with the largest outer diameter on the balloon body due to the fact that the metal ring is difficult or can not be compressed, and meanwhile, the inner cavity tube is folded, the pushing performance is poor, even the lesion position can not be reached due to the fact that the metal ring is poor in flexibility/flexibility of metal in tortuous complex lesions, and the operation result is affected.

Similar to the lumen tube, but different from the same, the tip of the balloon catheter is the most distal end of the entire balloon catheter system, and is too soft to be damaged to affect the tracking, pushing, etc. of the balloon catheter, and too hard to cause the balloon catheter to pass through tortuous lesions, and needs to have certain flexibility. When the balloon catheter is pushed into the blood vessel by a doctor, if the tail end is of a double-layer or multi-layer structure, deformation or layering phenomenon possibly occurs when the tail end is subjected to external pressure of the blood vessel wall, so that the tail end of the balloon catheter cannot be well attached to a guiding guide wire, the traceability and the pushing performance of the balloon catheter are poor, and even the lesion position cannot be reached, and the operation result is influenced.

Disclosure of Invention

Aiming at the problems in the prior art, the invention aims to provide a balloon catheter, which is characterized in that a supporting layer is added in an inner cavity tube and/or an end tube to ensure that the inner cavity tube and/or the end tube cannot deform to tightly hold a guide wire, a groove is arranged on the surface of the supporting layer to improve the bonding contact area between the supporting layer and other layers of the inner cavity tube, the bonding strength between two or more layers is improved, and the layering phenomenon in the use process is avoided.

The embodiment of the invention provides a balloon catheter, which comprises a balloon body, an inner cavity tube and an end tube, wherein the inner cavity tube penetrates through the balloon body, the end tube is connected with the distal end of the balloon body and/or the distal end of the inner cavity tube, the inner cavity tube and/or the end tube comprises a supporting layer, and the supporting layer is formed by wires;

The inner cavity tube and/or the tail end tube further comprises an inner layer positioned on the inner side of the supporting layer and/or an outer layer positioned on the outer side of the supporting layer, and at least one groove is formed in the surface of at least one side of the supporting layer.

In some embodiments, the support layer is formed from the wire spiral wound spring structure, or the support layer is formed from the wire cross-knit structure, or the support layer comprises a combination of spiral wound spring structure and cross-knit structure.

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.

In some embodiments, the wire has a width of 0.0005 inches to 0.006 inches and/or a thickness of 0.0005 inches to 0.006 inches;

the width of the groove is 3-80 μm, and/or the depth of the groove is 3 nm-30 μm.

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.

In some embodiments, the wire is a developable wire.

In some embodiments, the developable strand is a metal strand or a high molecular polymer strand doped with a developer.

In some embodiments, the balloon body includes a straight section and a first transition section on a 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, and the density of wires of the support layer at the first region is different from the density of wires of the support layer at the second region.

In some embodiments, the support layer is formed by the spiral winding of the wire, or the support layer is formed by the cross-braiding of the wire;

The density of the wires of the supporting layer at the first area is 500-800 spiral or knitting nodes per unit inch, and the density of the wires of the supporting layer at the second area is 200-300 spiral or knitting nodes per unit inch.

In some embodiments, the inner lumen tube and the tip tube each include the support layer, the support layer having a different density of wires at the tip tube than the support layer at the second region.

In some embodiments, the density of the wires of the support layer at the tip 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 lumen tube, or the density of the wires of the support layer at the tip tube is the same as the density of the wires of the support layer at the first region.

In some embodiments, the balloon body includes a straight section, the lumen tube includes a first region corresponding to the straight section, the first region including a central region, an end region, and a connection region between the central region and the end region, the support layer having a different density of wires at the connection region than the support layer.

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

In some embodiments, the balloon body includes a straight section, the portion 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 portion of the inner layer and/or the outer layer corresponding to the tip tube is doped with a developer.

The balloon catheter provided by the invention has the following advantages:

The invention provides a balloon catheter, which is characterized in that a supporting layer is added in an inner cavity tube and/or an end tube to ensure that the inner cavity tube and/or the end tube cannot deform, so that the problem that the inner cavity tube holds a guide wire tightly and/or the end tube is folded is avoided, a groove is arranged on the surface of the supporting layer to improve the bonding contact area between the supporting layer and other layers of the inner cavity tube, the bonding strength between two or more layers is improved, the layering phenomenon is avoided in the use process, when the supporting layer is added in the inner cavity tube, the self-lumen of the inner cavity tube cannot deform while the inner cavity tube supports the balloon, namely the phenomenon that the inner cavity tube holds the guide wire tightly and cannot track the guide wire for conveying is avoided, and when the supporting layer is added in the end tube, the phenomenon that the end tube is deformed or layered due to external pressure in the use process can be avoided to influence the pushing performance. The balloon catheter of the present invention may be an intracranial balloon catheter, or a balloon catheter for a blood vessel or body lumen in other locations.

Further, in some embodiments, the support layer of the present invention may be composed of a developable wire, the development effect of the balloon catheter is achieved by the support layer, and the development intensity of different regions can be adjusted by adjusting the density of the wire in the different regions, so that a doctor can determine the position of each region of the balloon catheter by the development effect.

Drawings

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

FIG. 1 is a schematic structural view of a balloon catheter according to a first embodiment of the present invention;

FIG. 2 is a cross-sectional view of the distal end of the lumen tube and the tip tube of the balloon catheter of the first embodiment of the present invention;

FIG. 3 is a schematic view of the structure of a first support layer according to a first embodiment of the present invention;

FIG. 4 is a cross-sectional view of the distal end of the lumen tube and the tip tube of the balloon catheter according to the second embodiment of the present invention;

FIG. 5 is a cross-sectional view of the distal end of the lumen tube and the tip tube of the balloon catheter according to the third embodiment of the present invention;

FIG. 6 is a cross-sectional view of the distal end of the lumen tube and the tip tube in the balloon catheter according to the fourth embodiment of the present invention;

FIG. 7 is a cross-sectional view of the distal end of the lumen tube and the tip tube in the balloon catheter according to the fifth embodiment of the present invention;

FIG. 8 is a cross-sectional view of the distal end of the lumen tube and the tip tube in a balloon catheter according to a sixth embodiment of the present invention;

FIG. 9 is a cross-sectional view of the distal end of the lumen tube and the tip tube in a balloon catheter according to a seventh embodiment of the present invention;

FIG. 10 is a cross-sectional view of the distal end of the lumen tube and the tip tube in the balloon catheter according to the eighth embodiment of the present invention;

FIG. 11 is a cross-sectional view of the distal end of the lumen tube and the tip tube in the balloon catheter according to the ninth embodiment of the present invention;

FIG. 12 is a cross-sectional view of the distal end of the lumen tube and the tip tube in the balloon catheter according to the tenth embodiment of the present invention;

fig. 13 is a schematic structural view of a second support layer according to a tenth embodiment of the present invention.

Reference numerals:

10. Balloon catheter 121 first region

11. Balloon 122 second region

111. Third region of straight section 123

112. First transition section 13 end pipe

113. Second transition section 13a second inner layer

12. Second support layer of lumen tube 13b

12A first inner layer 13b1 second groove

12B first support layer 13c second outer layer

12B1 first groove 14 outer tube

12C first outer layer 15 diffusion stress tube

12D first adhesive layer 16 saccule seat

Detailed Description

Example embodiments will now be described more fully with reference to the accompanying drawings. However, the exemplary embodiments can be embodied in many different forms and the present invention should not be construed as limited to the embodiments set forth herein, but rather, the embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and thus a repetitive description thereof will be omitted. "or", "or" in the specification may each mean "and" or ".

The invention provides a balloon catheter which comprises a balloon body, an inner cavity tube and an end tube, wherein the inner cavity tube penetrates through the balloon body, the end tube is connected with the distal end of the balloon body and/or the distal end of the inner cavity tube, the inner cavity tube and/or the end tube comprises a supporting layer, and the supporting layer is formed by wires and is used for supporting the inner cavity tube so as to ensure that the inner cavity tube cannot deform to hold a guide wire tightly. The inner cavity tube and/or the tail end tube further comprises an inner layer positioned on the inner side of the supporting layer and/or an outer layer positioned on the outer side of the supporting layer, and at least one groove is formed in the surface of at least one side of the supporting layer so as to improve the bonding contact area between the supporting layer and other layers (inner layer and/or outer layer) of the inner cavity tube and improve the bonding strength between two or more layers. When the supporting layer is added in the inner cavity tube, layering phenomenon is avoided when the balloon is filled, so that the phenomenon that the balloon catheter cannot track the guide wire for conveying due to the fact that the inner cavity tube hugs the guide wire tightly is avoided when the self-body lumen of the inner cavity tube is not deformed while the inner cavity tube supports the balloon to be filled can be effectively guaranteed. When the supporting layer is added in the tail end pipe, the tail end pipe can be prevented from being deformed or layered due to external pressure in the use process, and the tracking performance and the pushing performance are prevented from being influenced. The balloon catheter of the invention can be an intracranial balloon catheter or a balloon catheter for vessels or body lumens at other positions.

The following describes the structure of balloon catheters according to various embodiments of the present invention in detail with reference to the accompanying drawings, and it is to be understood that the various embodiments are not limiting of the scope of the present invention.

As shown in fig. 1 and 2, a first embodiment of the present invention provides a balloon catheter 10, which includes a balloon body 11 and a lumen tube 12, wherein the lumen tube 12 penetrates through the balloon body 11, and the lumen tube 12 has a multi-layer structure. As shown in fig. 1, the balloon catheter 10 further includes a distal tube 13 disposed at a distal end side of the inner tube 12 and exposed outside the balloon body 11, an outer tube 14 disposed at a proximal end side of the inner tube 12 and sequentially connected, a diffusion stress tube 15, and a balloon seat 16, wherein the distal end of the balloon body 11 is fixed to the inner 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 tip tube 13, and the proximal end of the inner lumen tube 12 is located in the lumen distal to the outer tube 14. The distal end and the proximal end are referred to herein as the proximal end with respect to the operator, and the distal end with respect to the operator.

As shown in fig. 2, 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 12 b. The first inner layer 12a and the first outer layer 12c are preferably high molecular polymer layers. The first inner layer 12a is preferably a high molecular weight polymer with a low coefficient of friction, such as high density polyethylene, POM (polyoxymethylene), polytetrafluoroethylene or other fluoropolymer, to ensure smooth movement of the guidewire within the lumen of the inner lumen 12 when the balloon catheter is delivered. The first outer layer 12c may be made of a combination of high molecular weight polymers of the same hardness or different hardness, for example, polyamide, nylon, or both polyamide and nylon together (e.g., blended or spliced). In this embodiment, the tip tube 13 is connected to the distal end of the inner lumen tube 12 and/or the distal end of the balloon body 11, and the tip tube 13 includes a structure of a second inner layer 13a, a second support layer 13b, and a second outer layer 13 c. The second inner layer 13a and the second outer layer 13c are preferably high molecular polymer layers. The second inner layer 13a is preferably a high molecular polymer with a low friction coefficient, such as high density polyethylene, POM (polyoxymethylene), polytetrafluoroethylene or other fluorine-containing polymer. The second outer layer 13c may be made of a combination of high molecular polymers with the same hardness or different hardness, for example, made of polyamide, nylon, or a blend or splice of polyamide and nylon. In this embodiment, the tip tube 13 and the inner tube 12 may be separately prepared and then connected, or the tip tube 13 and the inner tube 12 may be integrally provided.

In this embodiment, the first support layer 12b is composed of a wire. The first supporting layer 12b is used for supporting the inner cavity tube 12, so as to improve the strength of the inner cavity tube 12 to resist the pressure of the balloon during filling, and ensure that the inner cavity tube 12 cannot deform to hold the guide wire tightly. The first support layer 12b and the first inner layer 12a or the first outer layer 12c may be bonded by hot pressing or bonding. At least one side surface of the first supporting layer 12b is provided with at least one first groove 12b1. When the first supporting layer 12b is combined with other layers, the contact area between the first supporting layer 12b and other layers can be increased, and meanwhile, the relative displacement between the first supporting layer 12b and the first inner layer 12a or the first outer layer 12c in the axial direction is limited, so that the bonding strength between two or more layers is remarkably improved, the layering phenomenon of the inner cavity tube 12 in the use process of the balloon catheter is avoided, the inner cavity tube 12 can be effectively ensured to support the balloon filling, the self lumen of the inner cavity tube 12 is not deformed, namely the phenomenon that the inner cavity tube 12 holds a guide wire tightly and the balloon catheter cannot track the guide wire delivery is avoided. The first supporting layer 12b and the first inner layer 12a or the first outer layer 12c are preferably bonded by hot pressing, and the material of the first inner layer 12a or the first outer layer 12c is deformed by heating to be partially embedded in the first groove 12b1, so that the bonding area is further increased, the limiting effect is enhanced, and the bonding strength between the first supporting layer 12b and the first inner layer 12a or the first outer layer 12c is further improved.

As shown in fig. 3, in this embodiment, the wires in the first supporting layer 12b are formed in a spiral winding manner, that is, the first supporting layer 12b is formed into a spring structure by spirally winding the wires. In fig. 3, the S direction indicates the axial direction of the first support layer 12b, which coincides with the axial direction of the inner tube 12, and the D direction indicates the radial direction of the first support layer 12b, which coincides with the radial direction of the inner tube 12. Specifically, the first supporting layer 12b may be formed by spirally winding a complete wire to obtain a spring structure, or may be formed by spirally winding a plurality of wires, where the plurality of wires are preferably parallel or nested with each other, or may be connected end to end in an axial direction. In this embodiment, the first grooves 12b1 are distributed on the surface of the wire rod and extend along the extending direction of the wire rod, and because the wire rod has a certain torsion in the spiral winding process, in the formed first supporting layer 12b of the spring structure, part of the first grooves 12b1 are distributed on the outer peripheral surface of the spring structure, and meanwhile, part of the first grooves 12b1 are distributed on the inner side surface of the spring structure. On the joint surface between the first support layer 12b and the first inner layer 12a and the first outer layer 12c, the area of the joint surface is reinforced along the entire extending direction of the wire rod, that is, the joint contact area between the first support layer 12b and the first inner layer 12a and the first outer layer 12c can be maximized.

The wire forming the first support layer 12b may be a flat wire or a round wire. The first groove 12b1 may be formed on the wire surface by laser, drawing, sandblasting, and/or other means. On a cross section of the first support layer 12b, the shape of the first groove 12b1 may be a sector groove, for example, a V-shaped groove, an arc groove, for example, a U-shaped groove, a circular groove, or an elliptical groove, or a polygonal groove, for example, a trapezoid groove, a rectangular groove, or the like. The cross section of the first support layer 12b is a cross section along the axial direction S of the first support layer 12 b.

In this embodiment, when the wire forming the first support layer 12b is a flat wire, the width of the wire may be selected to be 0.0005 inch to 0.006 inch, preferably 0.0005 inch to 0.003 inch. The thickness of the wire may be selected to be 0.0005 inch to 0.006 inch, preferably 0.0005 inch to 0.003 inch. When the wire is a round wire, the diameter of the wire may be selected to be 0.0005 inch to 0.006 inch, and preferably 0.0005 inch to 0.003 inch. In this embodiment, the width of the first groove 12b1 may be selected to be 3 μm to 80 μm, and preferably 3 μm to 40 μm, and the depth of the first groove 12b1 may be selected to be 3nm to 30 μm. In this embodiment, by reasonably designing the size of the wire and the size of the first groove 12b1, on one hand, the supporting strength of the first supporting layer 12b on the inner cavity tube 12 itself can be ensured, the deformation caused by the compression when the balloon 11 is filled can be avoided, and on the other hand, the bonding contact area between the first supporting layer 12b and other layers can be increased as much as possible, and the layering phenomenon occurring when the balloon 11 is filled can be avoided. Here, the width refers to the dimension in the S direction in fig. 3, the thickness of the wire refers to the dimension in the D direction in fig. 3, and the depth of the first groove 12b1 refers to the dimension in the D direction in fig. 3. The width and thickness of the wire and the width and depth of the first groove 12b1 are all exemplified herein, and in other alternative embodiments, the width and thickness of the wire and the width and depth of the first groove 12b1 may take values in the numerical ranges listed herein, and values outside the numerical ranges listed herein are all within the scope of the present invention.

In this embodiment, the ratio of the width of the first groove 12b1 to the width of the wire forming the first support layer 12b may be selected to be greater than 0 and less than or equal to 1/2, for example, 1/3, 1/4, 2/5, 3/8, 1/2, etc., and the ratio of the depth of the first groove 12b1 to the thickness of the wire may be selected to be greater than 0 and less than or equal to 1/2, for example, 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, the influence on the supporting strength of the first supporting layer 12b due to the excessively large design of the first groove 12b1 is avoided, and the effect that the combined contact area of the first supporting layer 12b and other layers cannot be well increased due to the excessively small design of the first groove 12b1 is avoided. But 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 may 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 may be other values, such as 3/5, 5/9, etc., which are all within the scope of the present invention.

The first support layer 12b of the present invention is also not limited to the structure shown in fig. 3. In another alternative embodiment, the first recess may be provided only on the inner side surface of the spring structure, i.e. the side surface of the spring structure facing the first inner layer 12a. In another alternative embodiment, the first groove may be provided only on the outer peripheral surface of the spring structure, that is, on the side surface of the spring structure facing the first outer layer 12 c. In yet another alternative embodiment, the wires may be formed in a cross-woven configuration, and the first support layer 12b may be a woven structure formed by weaving the wires. The first groove may extend in an extending direction of the wire. In yet another alternative embodiment, the first groove may include a plurality of pits distributed on the surface of the wire forming the first support layer 12b, and a plurality of the pits are spaced apart on the surface of the wire. Optionally, the pits are uniformly arranged along the extending direction of the wire. More than one row of dimples may be provided on the wire when the dimples are smaller. In other alternative embodiments, the wires forming the first support layer 12b may also be a combination of both spiral wound and cross woven structures, or other configurations or combinations that are not spiral wound and/or non-woven.

As shown in fig. 2, in this embodiment, the wires forming the first support layer 12b are developing wires, and the developing effect of the balloon catheter is achieved through the first support layer 12b, so that the structure of adding a hard developing metal ring with a certain wall thickness and length on the outer surface of the inner cavity tube 12 in the conventional developing manner can be replaced, the effective working length of the balloon body 11 is reflected by the developing performance of the inner cavity tube 12, and the diameter of the inner cavity tube 12 is not increased, so that the passing outer diameter of the balloon catheter can be reduced, and the capability of reaching the far-end intracranial blood vessel of the balloon catheter is provided. Specifically, the wire may be a metal wire. In this embodiment, the wire is spirally wound to form a metal spring structure or is cross-woven to form a metal braid structure. The metal spring structure or the metal braiding structure has better supporting property compared with the adoption of the high polymer layer. And the metal spring structure can improve the flexibility of the inner cavity tube 12 while guaranteeing the compressive capacity of the inner cavity tube 12, so that the balloon catheter can pass through the intracranial distal tortuous lesion blood vessel more, the pushing resistance is reduced, and the trafficability and the conveying performance of the balloon catheter are improved. More preferably, the first support layer 12b in this embodiment is a metal spring structure, further improving the flexibility of the lumen 12, and more easily conforming to the morphology of the blood vessel, so as to be able to reach more distal, tortuous lesion sites.

In this example, the metal used for the metal wire forming the first support layer 12b is preferably a platinum alloy such as platinum iridium/platinum nickel/platinum tungsten, an alloy such as tungsten or tantalum, or a metal material having a relatively good development effect such as gold, but the present invention is not limited to the metal materials listed here, and in other alternative embodiments, other metal materials than those listed here may be used. The metal wire material forming the first support layer 12b may be a drawn filler (DRAWN FILLED tabing, DFT), for example, a wire material containing a developing metal such as platinum or tantalum in nickel titanium. In another alternative embodiment, the wire may also be a high molecular polymer wire doped with a developer, for example, the wire may be a polyamide or nylon wire doped with a developer, which may be a barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, or the like.

In this embodiment, the second support layer 13b of the tip tube 13 may have a similar structure to the first support layer 13 a. Specifically, the second supporting layer 13b is formed of a wire material, and is used for supporting the end tube 13, so as to improve the strength of the end tube 13 to resist external pressure applied during use, and ensure that the end tube 13 cannot deform. The second support layer 13b and the second inner layer 13a or the second outer layer 13c may be bonded by hot pressing or bonding, etc. At least one side surface of the second supporting layer 13b is provided with at least one second groove. When the second supporting layer 13b is combined with other layers, the contact area between the second supporting layer 13b and other layers can be increased, and meanwhile, the relative displacement between the second supporting layer 13b and the second inner layer 13a or the second outer layer 13c in the axial direction is limited, so that the combination strength between two or more layers is remarkably improved, and the phenomenon that the end tube 13 is layered in the use process is avoided, so that the pushing performance is influenced. The second supporting layer 13b and the second inner layer 13a or the second outer layer 13c are preferably bonded by hot pressing, and the material of the second inner layer 13a or the second outer layer 13c is deformed by heating to be partially embedded in the second groove, so that the bonding area is further increased, the limiting effect is enhanced, and the bonding strength between the second supporting layer 13b and the second inner layer 13a or the second outer layer 13c is further improved.

In this embodiment, the second support layer 13b is a spring structure formed by spiral winding or a braid structure formed by cross braiding, or a combination of the spring structure and the braid structure. Preferably, the second supporting layer 13b is a spring structure, and is formed by spirally winding one complete wire or spirally winding a plurality of wires. The second grooves may be distributed entirely on the outer circumferential surface of the spring structure of the second support layer 13b, entirely on the inner surface of the spring structure, or partially on the outer circumferential surface of the spring structure and partially 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, the area of the bonding surface is reinforced along the whole extending direction of the wire rod, 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.

Also, the wire forming the second support layer 13b may be a flat wire or a round wire. The second groove may be laser, drawn, sandblasted and/or otherwise formed on the wire surface. On the cross section of the second supporting layer 13b, the shape of the second groove may be a sector groove, for example, a V-shaped groove, an arc groove, for example, a U-shaped groove, a circular groove, or an elliptical groove, or a polygonal groove, for example, a trapezoidal groove, a rectangular groove, or the like. The shape and size of the wire forming the second support layer 13b (width and thickness of flat wire or diameter of round wire), the size of the groove (width and depth) may be identical to the wire forming the first support layer 12b, or may be different from the wire forming the first support layer 12 b. For example, when the wire forming the second support layer 12b is a flat wire, the width of the wire may be selected to be 0.0005 inch to 0.006 inch, preferably 0.0005 inch to 0.003 inch. The thickness of the wire may be selected to be 0.0005 inch to 0.006 inch, preferably 0.0005 inch to 0.003 inch. When the wire is a round wire, the diameter of the wire may be selected to be 0.0005 inch to 0.006 inch, and preferably 0.0005 inch to 0.003 inch. In this embodiment, the width of the second groove may be selected to be 3 μm to 80 μm, and preferably 3 μm to 40 μm, and the depth of the second groove may be selected to be 3nm to 30 μm. In this embodiment, by reasonably designing the size of the wire and the size of the second groove, on one hand, the supporting strength of the second supporting layer 13b to the terminal tube 13 itself can be ensured, deformation caused by compression in the use process is avoided, and on the other hand, the bonding contact area between the second supporting layer 13b and other layers can be increased as much as possible, and layering and folding phenomena in the use process are avoided.

In this embodiment, the ratio of the width of the second groove to the width of the wire forming the second support layer 13b may be selected to be greater than 0 and less than or equal to 1/2, for example, 1/3, 1/4, 2/5, 3/8, 1/2, etc., and the ratio of the depth of the second groove to the thickness of the wire may be selected to be greater than 0 and less than or equal to 1/2, for example, 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, the influence on the supporting strength of the second supporting layer 13b due to the fact that the second groove is designed to be too large is avoided, and the effect that the combined contact area of the second supporting layer 13b and other layers cannot be well increased due to the fact that the second groove is designed to be too small is also avoided. But 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 may 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 may be other values, such as 3/5, 5/9, etc., which are all within the scope of the present invention.

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 a plurality of the pits are spaced apart on the surface of the wire. Optionally, the pits are uniformly arranged along the extending direction of the wire. More than one row of dimples may be provided on the wire when the dimples are smaller. In other alternative embodiments, the wires forming the second support layer 13b may be formed in other forms or combinations, not spirally wound and/or non-woven.

In this embodiment, the wire forming the second support layer 13b is a developing wire, and the developing effect of the balloon catheter is achieved by the second support layer 13 b. Specifically, the wire may be a metal wire. In this embodiment, the wire is spirally wound to form a metal spring structure or is cross-woven to form a metal braid structure. The metal spring structure or the metal braiding structure has better supporting property compared with the adoption of the high polymer layer. And the metal spring structure or the metal braiding structure can improve the flexibility of the tail end pipe 13 while guaranteeing the compressive capacity of the tail end pipe 13, so that the balloon catheter can pass through a lesion blood vessel with complicated intracranial distal end tortuosity, the pushing resistance is reduced, and the trafficability and the conveying performance of the balloon catheter are improved. More preferably, the second support layer 13b in this embodiment is a metal spring structure, which further improves the flexibility of the distal tube 13, and is more compliant with the morphology of the blood vessel, so as to be able to reach more distal, tortuous lesion sites.

In this example, the metal used for the metal wire forming the second support layer 13b is preferably a platinum alloy such as platinum iridium/platinum nickel/platinum tungsten, an alloy such as tungsten or tantalum, or a metal material having a relatively good development effect such as gold, but the present invention is not limited to the metal materials listed here, and in other alternative embodiments, other metal materials than those listed here may be used. The metal wire for forming the second support layer 13b may be a drawn filler (DRAWN FILLED tabing, DFT), for example, a wire containing a metal such as platinum or tantalum in nickel-titanium. In another alternative embodiment, the wire may also be a high molecular polymer wire doped with a developer, for example, the wire may be a polyamide or nylon wire doped with a developer, which may be a barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, or the like.

As shown in fig. 1, the balloon 11 includes a straight section 111 and a first transition section 112 located at a distal end side of the straight section 111, the first transition section 112 has a tapered structure from a proximal end to a distal end, and the straight section 111 of the balloon 11 is an effective working portion of the balloon 11. The inner lumen tube 12 includes a first region 121 corresponding to the straight section 111, a second region 122 corresponding to the first transition section 112, and the density of wires of the first support layer 12b at the first region 121 is different from the density of wires of the first support layer 12b at the second region 122. Therefore, the balloon catheter can better develop the effective working part of the balloon body 11, has development identification degree better than that of a single metal development ring or that of two development rings only added on the outer surface position of the inner cavity tube 12 corresponding to the two ends of the straight section 111 of the balloon body 11 in the prior art, and is more beneficial to a doctor to observe the position of the balloon. Here, the density of the wires refers to the degree of tightness of the arrangement of the wires, and may be expressed as the number of wires per unit length or unit area or the space ratio of the wires.

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

As shown in fig. 2, in this embodiment, the density of the wires of the first support layer 12b at the first region 121 is greater than the density of the wires of the first support layer 12b at the second region 122. The density of the first support layer 12b is expressed herein as PPI (number of spirals per unit inch or number of braiding nodes). I.e. the PPI of the first support layer 12b at the first region 121 is larger than the PPI of the first support layer 12b at the second region 122. For example, the density of the wires of the first support layer 12b at the first region 121 may be selected to be 500 to 800 spiral or braid nodes per unit inch, and the density of the wires of the first support layer 12b at the second region 122 may be selected to be 200 to 300 spiral or braid nodes per unit inch. The first supporting layer 12b is formed in the inner cavity tube 12 corresponding to the effective working part of the balloon body 11 in a higher-density spiral winding or braiding mode, so that the strength and the compression resistance of the inner cavity tube 12 can be improved, and the inner cavity tube is further ensured not to deform to hug the guide wire.

As shown in fig. 2, the density of the wires of the second support layer 13b of the tip tube 13 is different from the density of the wires of the first support layer 12b at the second region 122. To distinguish between the position of the tip tube 13 and the position of the lumen tube 12 at the time of development. In this embodiment, the PPI of the second support layer 13b of the tip tube 13 is between the PPI of the first support layer 12b at the first region 121 and the PPI at the second region 122 of the inner lumen tube 12, or the PPI of the second support layer 13b of the tip tube 13 is the same as the PPI of the first support layer 12b at the first region 121.

In this embodiment, therefore, the developability of the first region 121 of the inner lumen tube 12 corresponding to the straight section 111 of the balloon body 11 is equal to or stronger than the developability of the tip tube 13, while the developability of the second region 122 of the inner lumen tube 12 is weaker than the developability of the first region 121 and the tip tube 13. On the one hand, the visualization of the tail end tube 13 can enable a doctor to realize head end visualization under the condition of X rays in the operation process, and enable the doctor to intuitively know the length of the tail end tube 13 of the balloon catheter in the operation process, so that the doctor can conveniently adjust the position and the direction of the tail end tube 13 according to vascular conditions or pushing states in the operation process, and the safety of the balloon catheter in the release process is improved, on the other hand, the visualization of the part of the inner cavity tube 12 corresponding to the straight section 111 of the balloon body 11 is equal to or stronger than the visualization of the tail end tube 13, and the visualization of the second area 122 of the inner cavity tube 12 is weaker than the visualization of the first area 121 and the visualization of the tail end tube 13, so that the doctor can conveniently identify the effective working length of the balloon body 11.

As shown in fig. 4, a cross-sectional view of the distal and distal end of the lumen tube 12 in the balloon catheter according to the second embodiment of the present invention is shown. In the second embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The main difference between the second embodiment and the first embodiment is that the first outer layer 12c of the inner tube 12 is doped with a developer. Specifically, the first outer layer 12c of the inner tube 12 is a polyamide or nylon tube doped with a developer, which may be barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, or the like. Specifically, the developer may be added to the raw material thereof during extrusion for the preparation of the first outer layer 12c, resulting in a high molecular polymer layer doped with the developer. By adding a developer to the first outer layer 12c, the developing effect of the inner tube 12 can be further improved.

Preferably, the portion 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 developer. Meanwhile, 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 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 portion of the inner lumen 12 corresponding to the straight section 111 of the balloon 11 has a more prominent developability than other portions, which facilitates the doctor to observe the position of the effective working portion of the balloon 11. Preferably, the second outer layer 13c of the tip tube 13 is also doped with a developer. The second outer layer 13c of the end tube 13 is a polyamide or nylon tubing doped with a developer, which may be barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc.

The developability of the second outer layer 13c of the tip tube 13 and the first outer layer 12c of the first region 121 of the lumen tube 12 is further increased in this embodiment, and the developability of the first outer layer 12c of the first region 121 of the lumen tube 12 corresponding to the straight section 111 of the balloon body 11 may be equal to or stronger than the developability of the second outer layer 13c of the tip tube, while the developability of the first outer layer 12c of the second region 122 of the lumen tube 12 is weaker than the developability of the first outer layer 12c of the first region 121 and the second outer layer 13c of the tip tube 13, thus making the developability of the second region 122 as a whole more differentiated from the developability of the first region 121 as a whole and the entire tip tube 13, which is more intuitive for the doctor to observe. On the one hand, the visualization of the tail end tube 13 can enable a doctor to realize head end visualization under the condition of X rays in the operation process, and enable the doctor to intuitively know the length of the tail end tube 13 of the balloon catheter in the operation process, so that the doctor can conveniently adjust the position and the direction of the tail end tube 13 according to vascular conditions or pushing states in the operation process, and the safety of the balloon catheter in the release process is improved, on the other hand, the integral visualization of the first area 121 is equal to or stronger than the integral visualization of the tail end tube 13, and the integral visualization of the second area 122 of the inner cavity tube 12 is weaker than the integral visualization of the first area 121 and the integral visualization of the tail end tube 13, so that the doctor can conveniently identify the effective working length of the balloon body 11.

In another alternative embodiment, the first inner layer 12a may be doped with a developer in the inner lumen tube 12, or the first outer layer 12c and the first inner layer 12a may be doped with a developer. In the tip tube 13, the second inner layer 13a may be doped with a developer, or the second outer layer 13c and the second inner layer 13a may be doped with a developer. In still another alternative embodiment, the first outer layer 12c may be entirely doped with a developer, and the second outer layer 13c may be entirely doped with a developer. In yet another alternative embodiment, only the portion of the first outer layer 12c located in the first region 121 and the second outer layer 13c may be doped with a developer, while the PPI of the first support layer 12b as a whole remains uniform.

As shown in fig. 5, a cross-sectional view of the distal and distal end of the lumen tube 12 in a balloon catheter according to a third embodiment of the present invention is shown. In the third embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The main difference between the third embodiment and the first embodiment is that the end tube 13 only comprises the structure of the second outer layer 13c and the second inner layer 13a, without the second support layer. The second outer layer 13c at the position of the tip tube 13 may be thickened or the second inner layer 13a may be thickened so that both the inner diameter and the outer diameter of the tip tube 13 are kept identical to those of the inner tube 12. In other alternative embodiments, the inner and/or outer diameter of the tip tube 13 does not coincide with the inner and/or outer diameter of the inner lumen tube 12. Preferably, the outer diameter of the end tube 13 is tapered from the proximal end to the distal end, the outer diameter of the proximal end of the end tube 13 is the same as the outer diameter of the inner tube 12, the outer diameter of the distal end of the end tube 13 is smaller than the outer diameter of the inner tube 12, for example, a certain taper is formed at the most distal end of the end tube 13 by laser, so as to further improve the traceability, pushability and passability of the balloon catheter.

In the third embodiment, the first outer layer 12c of the inner tube 12 and/or the second outer layer 13c of the end tube 13 is a high molecular polymer layer partially 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 end tube 13 may also be a high molecular polymer layer without the developer as in the first embodiment shown in fig. 2.

As shown in fig. 6, a cross-sectional view of the distal end and tip tube of the lumen tube 12 in the balloon catheter according to the fourth embodiment of the present invention is shown. In the fourth embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 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.

Specifically, the first region 121 includes a center region, end regions, and a connection region between the center region and the end regions. The PPI at the connection region corresponding to the first support layer 12b is different from the PPI at the central region and the end region corresponding to the first support layer 12b, so that the position of the middle part of the balloon 11 is marked by the difference of developability, which is convenient for a doctor to judge the positions of the middle part while judging the two end parts of the effective working part of the balloon 11. Here, the length of the center region and the end regions of the straight section 111 in the axial direction of the inner lumen tube 12 may be set as required. Preferably, the PPI of the first support layer 12b at the connection region is smaller than the PPI of the first support layer 12b at the central region and the end regions, more in line with the clinician's need to observe the working segment and the location of the central point of the balloon 11.

In the fourth embodiment, the structure of the tip tube 13 is the same as that of the third embodiment shown in fig. 5. In another alternative embodiment, the structure of the tip tube 13 may also be the structure of the first embodiment as shown in fig. 2, and the PPI of the second support layer 13b at the location of the tip tube 13 may be selected as desired.

In the fourth embodiment, the first outer layer 12c of the inner tube 12 and/or the second outer layer 13c of the end tube 13 is a polymer layer 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 end tube 13 may also be a high molecular polymer layer without the developer as in the first embodiment shown in fig. 2.

As shown in fig. 7, a cross-sectional view of the distal end and tip tube of the lumen tube 12 in the balloon catheter according to the fifth embodiment of the present invention is shown. In the fifth embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The main difference between the fifth embodiment and the first embodiment is that the density of the wires of the first support layer 12b at the third region 123 is the same as the density of the wires of the first support layer 12b at the first region 121.

Specifically, the portion of the inner lumen 12 corresponding to the second transition section 113 of the balloon body 11 is a 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. The PPI of the supporting layer 12b at the first region 121 and the second region 122 in this embodiment may be set according to any of the first to sixth embodiments described above. The first outer layer 12c or the first inner layer 12a in this embodiment may be a high polymer layer not doped with a developer, a high polymer layer entirely doped with a developer, or a high polymer layer doped with a developer only in a portion corresponding to the first region 121. In this embodiment, the tip tube 13 may have a three-layer structure including the second outer layer 13c, the second support layer 13b, and the second inner layer 13a, or may have a two-layer structure including only the second outer layer 13c and the second inner layer 13 a. The second outer layer 13c or the second inner layer 13a may be a polymer layer not doped with a developer, a polymer layer entirely doped with a developer, or a polymer layer partially doped with a developer.

As shown in fig. 8, a cross-sectional view of the distal end and the tip tube of the lumen tube 12 in the balloon catheter according to the sixth embodiment of the present invention is shown. The sixth embodiment is further provided, compared to the fourth embodiment shown in fig. 6, 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.

As shown in fig. 9, a cross-sectional view of the distal end and the tip tube of the lumen tube 12 in the balloon catheter according to the seventh embodiment of the present invention is shown. The seventh embodiment differs from the balloon catheter 10 of the sixth embodiment shown in fig. 8 in that the tip tube 13 has a three-layer structure including a second outer layer 13c, a second inner layer 13a, and a second support layer 13b.

As shown in fig. 10, a cross-sectional view of the distal end and the tip tube of the lumen tube 12 in the balloon catheter according to the eighth embodiment of the present invention is shown. In the eighth embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The eighth embodiment differs from the first embodiment in that the inner lumen tube 12 includes only a first support layer 12b and a first outer layer 12c located outside the first support layer 12 b. The structure of the first support layer 12b in this embodiment may be the structure of the first support layer 12b of any one of the above-described first to seventh embodiments. The first outer layer 12c in this embodiment may be a high polymer layer not doped with a developer, a high polymer layer entirely doped with a developer, or a high polymer layer doped with a developer only in a portion corresponding to the first region 121. The tip tube 13 in this embodiment may have a structure including the second outer layer 13c and the second support layer 13b, or may have a single-layer structure including only the second outer layer 13 c. The second support layer 13b may be configured as the second support layer 13b according to any one of the first to seventh embodiments. The second outer layer 13c may be a high polymer layer not doped with a developer, a high polymer layer entirely doped with a developer, or a high polymer layer partially doped with a developer.

As shown in fig. 11, a cross-sectional view of the distal end and the tip tube of a lumen tube 12 in a balloon catheter according to a ninth embodiment of the present invention is shown. In the ninth embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The ninth embodiment differs from the first embodiment in that the inner lumen tube 12 includes only a first support layer 12b and a first inner layer 12a located inside the first support layer 12 b. The structure of the first support layer 12b in this embodiment may be the structure of the first support layer 12b of any one of the above-described first to eighth embodiments. The first inner layer 12a in this embodiment may be a high polymer layer not doped with a developer, a high polymer layer entirely doped with a developer, or a high polymer layer doped with a developer only in a portion corresponding to the first region 121. The tip tube 13 in this embodiment may have a structure including only the second inner layer 13a and the second support layer 13b, or may have a single-layer structure including only the second inner layer 13 a. The second supporting layer 13b may be the second supporting layer 13b according to any one of the first to eighth embodiments. The second inner layer 13a may be a polymer layer not doped with a developer, a polymer layer entirely doped with a developer, or a polymer layer partially doped with a developer.

As shown in fig. 12, a cross-sectional view of the distal end and the tip tube of the lumen tube 12 in the balloon catheter according to the tenth embodiment of the present invention is shown. In the tenth embodiment, the basic structural composition of the balloon catheter is the same as that of the balloon catheter 10 shown in fig. 1. The tenth embodiment is different from the first embodiment in that the inner tube 12 has a structure including a first inner layer 12a and a first outer layer 12c, the inner tube 12 does not include a first support layer, and the end tube 13 has a structure including a second support layer 13b and a second outer layer 13 c. The second outer layer 13c may have any of the structures of the second outer layer 13c described in the first to eighth embodiments. For example, the second outer layer 13c may be a high polymer layer not doped with a developer, a high polymer layer entirely doped with a developer, or a high polymer layer partially doped with a developer. As shown in fig. 13, the second support layer 13b may adopt the structure of the first embodiment described above, preferably a spring structure is formed by spiral winding of a wire, 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, the shape and size of the second groove 13b1 may be the same as or different from those of the first embodiment. Since there is no second inner layer in this embodiment, it is preferable that the outer surface of the second support layer 13b is provided with second grooves 13b1.

In another alternative embodiment, the inner tube 12 may be a structure including a first inner layer 12a and a first outer layer 12c, and the end tube 13 may be a structure including only a second inner layer 13a and a second support layer 13 b. In yet another alternative embodiment, the inner tube 12 may be a structure including a first inner layer 12a and a first outer layer 12c, the end tube 13 may be a structure including a second inner layer 13a, a second outer layer 13c and a second support layer 13b, and the inner surface and/or the outer surface of the second support layer 13b may be provided with second grooves 13b1. The second inner layer 13a may have the structure of the first embodiment, for example, a polymer layer not doped with a developer, a polymer layer entirely doped with a developer, or a polymer layer partially doped with a developer. In yet another alternative embodiment, the inner tube 12 may be configured to include only the first inner layer 12a or the first outer layer 12c, and the end tube 13 may be configured to include the second support layer 13b and the second inner layer 13a and/or the second outer layer 13 c.

As shown in fig. 12, in this embodiment, in order to improve the adhesion between the first inner layer 12a and the first outer layer 12c, a first adhesive layer 12d may be further included between the first inner layer 12a and the first outer layer 12c of the inner tube 12. The first adhesive layer 12d may be made of a linear polymer material such as low density polyethylene. In preparing the inner lumen 12, a first adhesive layer 12d may be added between the first inner layer 12a and the first outer layer 12c, and three layers may be integrally extruded. Because the inner tube 12 lacks a support layer, the strength and thickness of the first outer layer 12c need to be substantially increased in order to withstand the pressure of the balloon inflation, possibly sacrificing the flexibility of the inner tube 12 and the overall outer diameter of the balloon body 11.

In the first, second, fifth, seventh, eighth, ninth and tenth embodiments, the PPI of the second supporting layer 13b of the end tube 13 may be uniformly distributed along the axial direction of the end tube 13, or may be unevenly distributed, for example, the PPI of the portion of the second supporting layer 13b of the end tube 13 near the inner tube 12 is greater than the PPI of the other portion of the second supporting layer 13b, or the PPI of the portion of the second supporting layer 13b of the end tube 13 far from the inner tube 12 is greater than the PPI of the other portion of the second supporting layer 13b, etc. When the developer is added to the second outer layer 13c and/or the second inner layer 13a of the tip tube 13, the developer may be uniformly distributed or unevenly distributed in the axial direction of the tip tube 13.

In the first to ninth embodiments described above, the inner 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, between the first support layer 12b and the first outer layer 12c, or 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 at the same time.

In the first to tenth embodiments described above, the end tube 13 may 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 13 c.

In the various drawings of the present invention, the thickness of the various layers and the thickness relationship between the various layers are merely examples and are not intended to be limiting. Specifically, the thickness of each layer can be selected and set according to the needs, and all the layers are within the protection scope of the invention.

The foregoing is a further detailed description of the invention in connection with the preferred embodiments, and it is not intended that the invention be limited to the specific embodiments described. It will be apparent to those skilled in the art that several simple deductions or substitutions may be made without departing from the spirit of the invention, and these should be considered to be within the scope of the invention.

Claims (12)

1. The balloon catheter is characterized by comprising a balloon body, a cavity tube and a tail end tube, wherein the cavity tube penetrates through the balloon body, the balloon body comprises a straight section and a first transition section positioned on the distal end side of the straight section, the cavity tube comprises a first area corresponding to the straight section and a second area corresponding to the first transition section, the tail end tube is connected with the distal end of the balloon body and/or the distal end of the cavity tube, the cavity tube comprises a supporting layer, or the cavity tube and the tail end tube comprise a supporting layer, the supporting layer is composed of developing wires, and the density of the wires of the supporting layer at the first area is different from the density of the wires of the supporting layer at the second area;

The inner cavity tube further comprises an inner layer positioned on the inner side of the supporting layer and/or an outer layer positioned on the outer side of the supporting layer, or the inner cavity tube and the tail end tube further comprise an inner layer positioned on the inner side of the supporting layer and/or an outer layer positioned on the outer side of the supporting layer, and at least one side surface of the supporting layer is provided with at least one groove.

2. The balloon catheter of claim 1, further comprising an outer tube, the proximal end of the balloon body being secured to the outer tube, the support layer being helically wound from the wires to form a spring structure, or the support layer being cross-woven from the wires to form a woven structure, or the support layer comprising a combination of helically wound spring structures and cross-woven structures.

3. The balloon catheter of claim 1, wherein the groove extends along the direction of extension of the wire or the groove comprises a plurality of dimples distributed on the surface of the wire.

4. The balloon catheter of claim 1, wherein the wire has a width of 0.0005 inches to 0.006 inches and/or a thickness of 0.0005 inches to 0.006 inches;

the width of the groove is 3-80 μm, and/or the depth of the groove is 3 nm-30 μm.

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

6. The balloon catheter of claim 1, wherein the developable wire is a metal wire or a high molecular polymer wire doped with a developer.

7. The balloon catheter of claim 2, wherein the support layer has a density of wires at the first region of 500-800 spiral or braid nodes per unit inch and the support layer has a density of wires at the second region of 200-300 spiral or braid nodes per unit inch.

8. The balloon catheter of claim 1, wherein the inner lumen tube and the tip tube each comprise the support layer, the support layer having a different density of wires at the tip tube than the support layer at the second region.

9. The balloon catheter of claim 8, wherein a density of wires of the support layer at the tip tube is between a density of wires of the support layer at the first region and a density of wires of the lumen tube at the second region, or the support layer at the tip tube is the same as a density of wires of the support layer at the first region.

10. The balloon catheter of claim 1, wherein the first region comprises a central region, an end region, and a connection region between the central region and the end region, the support layer having a different density of wires at the connection region than the support layer at the central region and the end region.

11. The balloon catheter of claim 1, wherein the inner layer and/or the outer layer is a high molecular polymer layer at least partially doped with a developer.

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