A balloon catheter

Abstract

The present disclosure provides a balloon catheter, comprising: a balloon; an inner tube, arranged in the balloon, the inner tube comprising an inner layer, an outer layer and an intermediate layer, the intermediate layer being used to bond the inner layer and the outer layer, the outer layer material being one or more of the following materials: polyetheramide block copolymer, nylon or polyurethane; a guide wire port, the guide wire port being connected to the inner tube to set one end of the balloon; a tip tube, formed at the other end of the balloon and connected to the balloon; a hypotube, connected to one end of the balloon in a direction away from the guide wire port through a connecting tube. The present disclosure can ensure the safety of use, and can solve the problems of poor proximal maneuverability and passability and insufficient anti-collapse ability of the inner tube in the existing balloon catheter.

Description

Technical Field

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

[0002] Common vascular diseases include ischemic stenosis and hemorrhagic aneurysm. The disease that causes ischemic stenosis comes from atherosclerosis, which causes vascular stenosis and affects blood supply. The main means to solve this kind of disease in clinical practice include surgical bypass and minimally invasive interventional surgery. With the promotion of minimally invasive interventional medicine, the advancement of medical device technology, and the improvement of national awareness, coupled with the advantages of less trauma, short operation time, fast postoperative recovery, low surgical risk and cost, minimally invasive intervention has gradually replaced traditional surgery and developed rapidly. As a balloon catheter in the process of minimally invasive interventional surgery, it plays a key role in the operation. Combined with the requirements of surgical use, there are simple balloon dilatation, and also include the combination of balloon and stent or other devices. With the assistance of medical imaging equipment, through arterial puncture, a vascular access is established through a guide catheter. If the calcified lesion is mild, a simple balloon catheter can be used to dilate the calcified lesion. If the calcification lesion is severe and a stent needs to be placed, first use a balloon catheter to pre-expand the calcification, then press the balloon catheter with the stent, and as the balloon is filled, slowly open and release the stent, and finally withdraw the balloon catheter and surgical equipment. Combined with the clinical blood supply situation, further evaluate whether balloon post-expansion is needed. The stent that stays in the blood vessel can provide effective support for the blood vessel and achieve the purpose of stenosis.

[0003] Most common balloons on the market use a single-layer tube design, which is prone to insufficient pressure resistance when facing severe clinical calcified lesions; the inner tube is designed with two or three layers of polymer materials. When the calcified lesions are located in tortuous blood vessels or blood vessel intersections, the inner tube does not have good flexibility and there is a "bending" problem. At the same time, when facing high-pressure requirements, the inner tube cannot provide effective support and is prone to "collapse"; the hollow-designed single-layer metal hypotube has an unreasonable distal spiral design, which makes it impossible to smoothly transition the catheter hardness, resulting in poor overall passability of the balloon catheter; single-lumen tubes of multiple hardnesses are connected into one by laser welding, which increases the process and affects production efficiency and production costs. Summary of the invention

[0004] The present disclosure provides a balloon catheter, which can solve one or more problems of the balloon catheter mentioned in the background art, such as poor proximal maneuverability and passability, insufficient anti-collapse ability of the inner tube, etc. In order to solve the above technical problems, the present disclosure provides a balloon catheter, including:

[0005] Balloon;

[0006] An inner tube is arranged in the balloon, the inner tube comprises an inner layer, an outer layer and an intermediate layer, the intermediate layer is used to bond the inner layer and the outer layer, and the outer layer is made of one or more of the following materials: polyetheramide block copolymer, nylon or polyurethane;

[0007] A guide wire port, the guide wire port being connected to the inner tube and disposed at one end of the balloon;

[0008] a tip tube formed at the other end of the balloon and connected to the balloon;

[0009] The hypotube is connected to one end of the balloon away from the guide wire port through a connecting tube.

[0010] Optionally, the inner layer material is made of high-density polyethylene or modified etched polytetrafluoroethylene.

[0011] Optionally, the intermediate layer material is modified low-density polyethylene and / or linear low-density polyethylene.

[0012] Optionally, the tip tube includes a tip inner layer and a tip outer layer, and the outer radial direction of the tip outer layer gradually decreases away from the balloon.

[0013] Optionally, the inner layer material of the tip is high-density polyethylene or etched polytetrafluoroethylene; the Shore hardness of the outer layer material of the tip is 40A-55D.

[0014] Optionally, the balloon includes two end shoulders in contact with the inner tube and the tip tube and a balloon effective length region located between the two end shoulders.

[0015] Optionally, the balloon is a single-layer balloon, the shoulder materials at both ends are polyurethane, and the effective length region of the balloon is made of polyetheramide block copolymer or nylon;

[0016] Or, the balloon is a double-layer balloon, comprising a balloon inner layer and a balloon outer layer, the balloon inner layer material is polyetheramide block copolymer or nylon, and the balloon outer layer material is polyurethane;

[0017] Alternatively, the balloon is a three-layer balloon, comprising a balloon inner layer, a balloon middle layer and a balloon outer layer, the balloon inner layer material is polyetheramide block copolymer or nylon, and the balloon outer layer material is polyurethane.

[0018] Optionally, the taper of the shoulder away from the tip tube is smaller than the taper of the shoulder near the tip tube;

[0019] And / or, the other end of the hypotube away from the balloon direction is connected to one end of the diffusion stress tube, and the other end of the diffusion stress tube is connected to the catheter seat;

[0020] And / or, the surface of the connecting tube between the guide wire port and the balloon is coated with a distal coating;

[0021] And / or, a proximal coating is coated on the hypotube away from the guide wire port, and a marking band is provided on the hypotube between the diffusion stress tube and the proximal coating;

[0022] And / or, the hypotube is a single-layer metal hollow tube, the surface of the single-layer metal hollow tube is coated with a hydrophobic coating, and the hypotube close to the balloon direction is a variable density spiral or "hollow" straight or S-shaped strip wire; or, the hypotube includes a hypotube inner layer and a hypotube outer layer, the hypotube inner layer is an inner layer made of stainless steel or nickel-titanium metal wire, in a spiral twisted shape, and its surface contains polytetrafluoroethylene or parylene coating, and the hypotube outer layer is one of polyetheramide block copolymer or polyurethane or a combination thereof, and its surface contains One or a combination of polyvinyl pyrrolidone or hyaluronic acid coating; or, the hypotube includes a hypotube inner layer, a hypotube outer layer and a hypotube middle layer, the hypotube inner layer material is modified etched polytetrafluoroethylene or high-density polyethylene, the hypotube outer layer material is a polymer material, one or a combination of nylon and polyetheramide block copolymer, the material hardness of the hypotube away from the balloon direction is greater than the material hardness of the hypotube close to the balloon direction, and the hypotube middle layer material is stainless steel or nickel-titanium wire.

[0023] Optionally, a developing ring is provided on the inner tube located in the effective length area of ​​the balloon.

[0024] Optionally, the number of the developing rings is 1 or 2;

[0025] Or, the developing circle is a continuous developing circle or an intermittent developing circle;

[0026] And / or, the developing ring is a spring ring made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy or gold.

[0027] The beneficial effects of the present disclosure are:

[0028] 1) The outer layer material of the inner tube is one of polyetheramide block copolymer (PEBAX), nylon (NYLON), polyurethane (PU) or a combination thereof, which is used to improve the tensile strength and elongation at break of the tube and ensure the safety of use. The inner layer material of the inner tube is one of high-density polyethylene (HDPE) and modified etched polytetrafluoroethylene (e-PTFE) with a low friction coefficient, which is used to reduce the push resistance of the guide wire or other instruments in the inner cavity. The middle layer material of the inner tube is one of modified low-density polyethylene (LDPE) and linear low-density polyethylene (LLDPE) or a combination thereof, which is used to bond the polar outer layer and the non-polar inner layer to avoid delamination.

[0029] 2) The balloon adopts a multi-layer balloon structure design, preferably a double-layer or triple-layer one. The hardness of the balloon material decreases from the inside to the outside. The high-hardness inner layer ensures the pressure resistance of the balloon, and the low-hardness outer layer ensures softness and reduces tearing of the inner wall of the target blood vessel.

[0030] 3) The outer diameter of the tip tube adopts a "gradual taper" design to improve passability and reduce the "fish mouth" effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the overall structure of the balloon catheter;

[0032] Figure 2 It is a schematic diagram of the cross-sectional structure of the tip tube of the balloon catheter;

[0033] Figure 3 It is a schematic diagram of the design structure of the distal spiral hypotube in the balloon catheter;

[0034] Figure 4 It is a schematic diagram of the design structure of the distal hollow hypotube in the balloon catheter;

[0035] Figure 5 It is a schematic diagram of the design structure of the torsion spring hypotube in the balloon catheter;

[0036] Figure 6 It is a schematic diagram of the braided cross-sectional structure of the inner tube in the balloon catheter;

[0037] Figure 7 It is a schematic diagram of the cross-sectional structure of the inner tube spring in the balloon catheter;

[0038] Figure 8 It is a schematic diagram of the cross-sectional structure of a balloon in a balloon catheter;

[0039] Figure 9 It is a schematic diagram of the diffusion stress tube structure in the balloon catheter.

[0040] Wherein, each figure is indicated by a number:

[0041] 1-tip tube; 2-balloon; 3-developing ring; 4-inner tube; 5-distal coating; 6-hypotube; 7-diffusion stress tube; 8-catheter seat; 9-connecting tube; 10-proximal coating; 11-guidewire port; 12-marking band. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present disclosure.

[0043] The present invention provides a balloon catheter, such as Figures 1-9 As shown, including:

[0044] Balloon 2;

[0045] The inner tube 4 is arranged in the balloon 2, such as Figures 6-7 As shown, the inner tube 4 includes an inner layer 4a, an outer layer 4c and an intermediate layer 4b, wherein the intermediate layer 4b is used to bond the inner layer 4a and the outer layer 4c, and the outer layer 4c is made of one or more of the following materials: polyetheramide block copolymer, nylon or polyurethane; and is used to improve the tensile strength and elongation at break of the tube to ensure safety in use;

[0046] A guide wire port 11, wherein the guide wire port 11 is connected to the inner tube 4 and one end of the balloon 2 is provided;

[0047] a tip tube 1 formed at the other end of the balloon 2 and connected to the balloon 2;

[0048] The hypotube 6 is connected to one end of the balloon 2 in a direction away from the guide wire port 11 through a connecting tube 9. The connecting tube 9 is made of a two-component mixture of nylon (NYLON), polyether amide block copolymer (PEBAX), and polyurethane (PU). The connecting tube 9 realizes a smooth transition connection between the hypotube and the balloon by one or a combination of heat shrinkage or laser welding.

[0049] In some embodiments, the inner layer 4a is made of high-density polyethylene or modified etched polytetrafluoroethylene to reduce the pushing resistance of the guide wire or other instruments in the inner cavity.

[0050] In some embodiments, the material of the middle layer 4b is a modified low-density polyethylene, in some embodiments, a linear low-density polyethylene, which is used to bond the polar outer layer and the non-polar inner layer to avoid delamination. The material of the middle layer is one or a combination of medical materials such as polymer fiber wire, stainless steel wire, nickel-titanium wire, gold wire, platinum-nickel wire, platinum-tungsten wire, etc.; the shape of the metal wire includes but is not limited to one of round wire or rectangular wire; the middle layer adopts one or a combination of braided or spiral spring designs, and the braided or spiral spring adopts one or a combination of equal pitch or variable pitch designs.

[0051] In some embodiments, the tip tube 1 includes a tip inner layer and a tip outer layer, and the outer diameter of the tip outer layer gradually decreases away from the balloon 2. Further, the Shore hardness of the outer layer material is preferably 40A-55D. The tip outer diameter adopts a "gradual taper" design to improve passability and reduce the "fish mouth" effect.

[0052] In some embodiments, the inner layer material of the tip is high-density polyethylene or etched polytetrafluoroethylene; the Shore hardness of the outer layer material of the tip is 40A-55D.

[0053] In some embodiments, the balloon 2 includes two end shoulders in contact with the inner tube 4 and the tip tube 1 and an effective length region of the balloon 2 located between the two end shoulders.

[0054] In some embodiments, the balloon 2 is a single-layer balloon, the shoulder materials at both ends are polyurethane, and the effective length region material of the balloon 2 is polyetheramide block copolymer or nylon; the material tube for molding the balloon 2 is processed by continuous extrusion, injection molding or melt seamless welding.

[0055] In some embodiments, the balloon 2 is a double-layer balloon, comprising a balloon inner layer and a balloon outer layer. The inner layer material of the balloon 2 is polyetheramide block copolymer or nylon, and the outer layer material of the balloon 2 is polyurethane. Furthermore, the hardness of the balloon material decreases from the inside to the outside, the high-hardness inner layer ensures the pressure resistance of the balloon, and the low-hardness outer layer ensures softness, reducing tearing of the inner wall of the target blood vessel.

[0056] In some embodiments, the balloon 2 is a three-layer balloon, comprising a balloon inner layer, a balloon middle layer and a balloon outer layer. The balloon inner layer material is polyetheramide block copolymer or nylon, and the balloon outer layer material is polyurethane.

[0057] In some embodiments, the taper of the shoulder away from the tip tube 1 is smaller than the taper of the shoulder close to the tip tube 1; the taper angle of the distal shoulder of the balloon 2 is 10°-30°, and the taper angle of the proximal shoulder of the balloon 2 is 15°-45°. Furthermore, the taper of the distal shoulder of the balloon 2 is smaller than that of the proximal shoulder, which improves the passability of the balloon catheter and reduces the inflation and decompression time, shortening the operation time. The modification method of the balloon 2 includes one of plasma treatment, surface etching treatment, and surface grafting treatment.

[0058] In some embodiments, the other end of the hypotube 6 away from the balloon 2 is connected to one end of the diffusion stress tube 7, and the other end of the diffusion stress tube 7 is connected to the catheter seat;

[0059] In some embodiments, the surface of the connecting tube 9 between the guide wire port 11 and the balloon 2 is coated with a distal coating 5;

[0060] In some embodiments, a proximal coating is coated on the sea wave tube 6 away from the guide wire port 11, and a marking band 12 is arranged on the sea wave tube 6 between the diffusion stress tube 7 and the proximal coating; the diffusion stress tube 7 is made of one of high-density polyethylene (HDPE) and polyamide (PA), and adopts a variable pitch "hollow" structure design.

[0061] In some embodiments, the sea wave tube 6 is a single-layer metal hollow tube, the surface of which is coated with a hydrophobic coating, and the sea wave tube 6 close to the balloon 2 is a variable density spiral or "hollow" straight or S-shaped strip wire.

[0062] In some embodiments, the hypotube 6 includes a hypotube inner layer and a hypotube outer layer, wherein the hypotube inner layer is made of stainless steel or nickel-titanium wire, and is in a spiral twisted shape, and its surface contains polytetrafluoroethylene or parylene coating, and the hypotube outer layer is one of polyetheramide block copolymer or polyurethane or a combination thereof, and its surface contains one of polyvinyl pyrrolidone or hyaluronic acid coating or a combination thereof.

[0063] In some embodiments, the hypotube 6 includes a hypotube inner layer 6a, a hypotube outer layer 6c and a hypotube middle layer 6b, the hypotube inner layer 6a is made of modified etched polytetrafluoroethylene or high-density polyethylene, the hypotube outer layer 6c is made of a polymer material, one of nylon and polyetheramide block copolymer or a combination thereof, the material hardness of the hypotube outer layer 6c away from the balloon 2 is greater than the material hardness of the hypotube outer layer close to the balloon 2, and the hypotube middle layer 6b is made of stainless steel or nickel-titanium wire. For example, the wire shape includes but is not limited to one of round wire and rectangular wire or a combination thereof; the middle layer wire adopts a variable density spiral braiding mode, and the braiding density PPI=100-300.

[0064] In some embodiments, a developing ring 3 is provided on the inner tube 4 located in the effective length area of ​​the balloon 2. The developing ring 3 is embedded on the inner tube or located in the middle layer of the inner tube to mark the position of the balloon in the blood vessel and assist in measuring the length of the lesion.

[0065] In some embodiments, the number of the developing rings 3 is 1 or 2;

[0066] In some embodiments, the developing ring 3 is a continuous developing ring 3 or an intermittent developing ring 3; the continuous developing spring ring adopts a tight spring winding design at both ends of its length, with a spring winding length of 0.5 to 1.5 mm, and an interval spring winding design is adopted in the middle area, adopting one of equal pitch, variable pitch or a combination thereof, and the length changes with the effective length of the balloon.

[0067] In some embodiments, the developing ring 3 is a spring ring made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy or gold.

[0068] Specific examples are given below to illustrate the above implementation mode:

[0069] Example 1

[0070] The diffusion stress tube 7 in this embodiment adopts a polyamide (PA) variable pitch "hollow" structure design A, and is fixed to the catheter seat 8 by an inverted buckle. The tip tube 1 is a double-layer structure design, the inner layer is etched polytetrafluoroethylene (e-PTFE), and the outer layer is a polyetheramide block copolymer (PEBAX4033). The balloon 2 adopts a single-layer structure design, the shoulders at both ends of the balloon are made of polyurethane (PU), the effective length of the balloon is made of polyetheramide block copolymer (PEBAX6333), and the balloon material tube is formed by melt seamless welding. The taper angle of the distal shoulder of the balloon is 15°, and the taper angle of the proximal shoulder of the balloon is 30°. The balloon surface is plasma treated, and the outer surface contains a hydrophilic coating PVP. The connecting tube 9 uses nylon (PA12) and polyetheramide block copolymer (PEBAX7233) with a weight mixing ratio of 1:1. The sea wave tube 6 is a medical 304 stainless steel single-layer metal hollow tube. The distal end of the hollow tube adopts a variable pitch design. The distal end section contains an extended straight wire and the surface contains a polytetrafluoroethylene (PTFE) coating. The inner tube 4 is a three-layer structure design, in which the inner layer is high-density polyethylene (HDPE), the middle layer is modified low-density polyethylene (LDPE), and the outer layer is a polyetheramide block copolymer (PEBAX7233). The developing ring 3 uses a 0.5mm long platinum-iridium alloy spring coil. The inner tube 4 is located in the middle of the effective length area of ​​the balloon 2 or its two end pins contain 1 or 2 developing rings 3. The outer layer of the inner tube developing ring 3 is mechanically or laser processed to form a concave shape, ensuring that the developing ring 3 is effectively embedded in the depression through mechanical compression and gripping, and remains level with the outer layer of the non-depressed area.

[0071] Example 2

[0072] Compared with Example 1, the diffusion stress tube 7 in this embodiment adopts high-density polyethylene (HDPE). The inner layer of the tip tube 1 is etched polytetrafluoroethylene (e-PTFE), and the outer layer is polyurethane (Pallethane2363-80AE). The balloon 2 adopts a double-layer structure design, the inner layer of the balloon is polyetheramide block copolymer (PEBAX7233), and the outer layer of the balloon is polyurethane (Pallethane2363-80AE). The hypotube 6 is a double-layer structure design, the inner layer material of the hypotube is stainless steel round wire, spiral twisting design, and the surface of the metal wire contains polytetrafluoroethylene (PTFE) coating; the outer layer of the hypotube is polyetheramide block copolymer (PEBAX4033) with lower hardness, and the surface of the outer layer material contains polyvinylpyrrolidone (PVP). The inner tube 4 is designed with a three-layer structure, in which the inner layer material is etched polytetrafluoroethylene (e-PTFE); the middle layer is a platinum tungsten spring coil with a variable pitch design, and the two ends of the spring coil adopt a tight spring winding mode with a length of 0.6mm, and the outer layer is a polyetheramide block copolymer (PEBAX7033).

[0073] Example 3

[0074] Compared with Example 1, the inner layer of the tip tube 1 is etched polytetrafluoroethylene (e-PTFE), and the outer layer is polyurethane (TT-1085A). The balloon 2 adopts a three-layer structure design, the inner layer of the balloon is polyetheramide block copolymer (PEBAX7233), the middle layer of the balloon is polyetheramide block copolymer (PEBAX7033), and the outer layer of the balloon is polyurethane (Pallethane2363-80AE). The connecting tube 9 adopts polyetheramide block copolymer (PEBAX7233) and polyurethane (Pallethane2363-80AE) with a weight mixing ratio of 2:1. The hypotube 6 selects a medical 316 stainless steel single-layer metal hollow tube, the distal end of the hollow tube adopts a variable pitch design, the distal end segment contains an extended S-type wire, and the outer surface of the metal is coated with a hydrophobic Parylene coating. The inner tube 4 is a three-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), the middle layer is polymer fiber, and the outer layer is polyetheramide block copolymer (PEBAX7033). The developing ring 3 uses a 0.8mm long gold spring ring. The inner tube 4 is located in the middle of the effective area length of the balloon 2 or the two end pins contain one or two developing rings 3, as in Example 1, embedded in the recess of the embedded inner tube.

[0075] Example 4

[0076] Compared with Example 1, the diffusion stress tube 7 in this embodiment adopts high-density polyethylene (HDPE). The inner layer of the tip tube 1 is etched polytetrafluoroethylene (e-PTFE), and the outer layer of the tip tube is polyurethane (Pallethane2363-80AE). The balloon 2 adopts a double-layer structure design, the inner layer of the balloon is polyetheramide block copolymer (PEBAX7033), and the outer layer of the balloon is polyurethane (TT-1085A). The connecting tube 9 adopts a weight mixing ratio of 2:1 polyetheramide block copolymer (PEBAX7033) and polyurethane (TT-1085A). The hypotube 6 adopts a three-layer structure design, the inner layer of the hypotube is etched polytetrafluoroethylene (e-PTFE), the middle layer of the hypotube is medical 304 stainless steel and nickel-titanium round wire, and a variable density spiral braiding mode is adopted. The braiding density of the proximal end of the hypotube is greater than that of the distal end. The outer layer of the hypotube is polyetheramide block copolymer (PEBAX7433). The inner tube 4 is designed as a double-layer structure, wherein the inner layer is high-density polyethylene (HDPE), the middle layer is a nickel-titanium spring coil with a variable pitch design, both ends of the spring coil adopt a tight spring winding mode, the length is 0.8 mm, and the outer layer is a polyetheramide block copolymer (PEBAX7033).

[0077] Example 5

[0078] Compared with Example 1, the inner layer of the tip tube 1 is etched polytetrafluoroethylene (e-PTFE), and the outer layer is polyurethane (TT-1085A). The balloon 2 adopts a three-layer structure design, the inner layer of the balloon is polyamide (PA12), the middle layer of the balloon is polyetheramide block copolymer (PEBAX7033), and the outer layer is polyurethane (TT-1085A). The connecting tube 9 adopts polyamide (PA12) and polyurethane (TT-1085A) with a weight mixing ratio of 3:2. The hypotube 6 is a double-layer structure design, the inner layer material of the hypotube is medical nickel-titanium rectangular wire, the spiral twisting design, and the surface of the metal wire contains Parylene coating; the outer layer of the hypotube is polyurethane (TT-1085A) with lower hardness, and the surface of the outer layer material contains hyaluronic acid (HA) coating. The inner tube 4 is a three-layer structure design, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), and the middle layer adopts an equal pitch braiding mode. The developing ring 3 is a platinum-iridium alloy spring ring with a length of 1.0 mm, as in Example 1, and is embedded in the recess of the embedded inner tube.

[0079] Example 6

[0080] Compared with Example 1, the balloon 2 in this embodiment adopts a double-layer structure design, the inner layer of the balloon is polyamide (PA12), and the outer layer of the balloon is polyurethane (Pallethane2363-80AE). The taper angle of the distal shoulder of the balloon is 20°, and the taper angle of the proximal shoulder of the balloon is 25°. The surface of the balloon is etched, and the outer surface contains a hydrophilic coating PVP. The connecting tube 9 uses a polyetheramide block copolymer (PEBAX7233) and polyurethane (Pallethane2363-80AE) with a weight mixing ratio of 1:1. The hypotube 6 selects a medical 304 stainless steel single-layer metal hollow tube, and the distal end of the hollow tube adopts a variable pitch "hollow" design, and the distal end segment contains an extended straight wire, and the surface contains a polytetrafluoroethylene (PTFE) coating. The inner tube 4 is designed with a three-layer structure, wherein the inner layer is high-density polyethylene (HDPE), the middle layer is polymer fiber filament, a variable pitch helical spring design is adopted, and the outer layer is polyetheramide block copolymer (PEBAX7033). The developing ring 3 adopts a 1.0mm long platinum tungsten alloy spring ring. The inner tube 4 is located at the two end pins of the effective area length of the balloon 2 and contains two developing rings 3. As in Example 1, it is embedded in the recess of the embedded inner tube.

[0081] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] The above are only the preferred embodiments of the present invention, and do not limit the patent scope of the present invention accordingly. Without departing from the spirit of the present invention, those skilled in the art, by making equivalent structural or equivalent process transformations using the content of the specification and drawings of the present invention, directly or indirectly applied in other related technical fields, shall equally be included in the patent protection scope of the present invention.

[0083] Although the embodiments of the present disclosure have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present disclosure, and the scope of the present disclosure is defined by the appended claims and their equivalents.

Claims

1. A balloon catheter, characterized in that, include: The balloon comprises an outer layer of the balloon, wherein the outer layer of the balloon is made of polyurethane; An inner tube is arranged in the balloon, the inner tube comprises an inner layer, an outer layer and an intermediate layer, the intermediate layer is used to bond the inner layer and the outer layer, and the outer layer is made of one or more of the following materials: polyetheramide block copolymer, nylon or polyurethane; A guide wire port, the guide wire port being connected to the inner tube and disposed at one end of the balloon; A tip tube is formed at the other end of the balloon and connected to the balloon; the tip tube includes a tip inner layer and a tip outer layer, and the outer diameter of the tip outer layer gradually decreases away from the balloon; the tip inner layer material is high-density polyethylene or etched polytetrafluoroethylene; the tip outer layer material is polyurethane; the balloon includes two end shoulders in contact with the inner tube and the tip tube and a balloon effective length area located between the two end shoulders; the taper of the shoulder away from the tip tube is smaller than the taper of the shoulder close to the tip tube; the Shore hardness of the tip outer layer material is 40A-55D; A hypotube is connected to one end of the balloon in a direction away from the guide wire port through a connecting tube; the hypotube comprises a hypotube inner layer, a hypotube outer layer and a hypotube middle layer, the hypotube inner layer material is modified etched polytetrafluoroethylene or high-density polyethylene, the hypotube outer layer material is a polymer material, one of nylon and polyetheramide block copolymer or a combination thereof, the material hardness of the hypotube outer layer in a direction away from the balloon is greater than that of the hypotube in a direction close to the balloon, and the hypotube middle layer material is stainless steel or nickel-titanium wire; The other end of the hypotube away from the balloon direction is connected to one end of the diffusion stress tube, and the other end of the diffusion stress tube is connected to the catheter seat.

2. The balloon catheter according to claim 1, wherein, The inner layer material is high-density polyethylene or modified etched polytetrafluoroethylene.

3. The balloon catheter according to claim 1 or 2, characterized in that, The intermediate layer material is modified low-density polyethylene and / or linear low-density polyethylene.

4. The balloon catheter according to claim 1, wherein The balloon is a double-layer balloon, comprising a balloon inner layer and a balloon outer layer, and the balloon inner layer material is polyetheramide block copolymer or nylon.

5. The balloon catheter according to claim 1, characterized in that, The balloon is a three-layer balloon, comprising a balloon inner layer, a balloon middle layer and a balloon outer layer, and the balloon inner layer material is polyetheramide block copolymer or nylon.

6. The balloon catheter according to claim 1, wherein The surface of the connecting tube between the guide wire port and the balloon is coated with a distal coating.

7. The balloon catheter according to claim 1, wherein, A proximal coating is coated on the hypotube away from the guide wire port, and a marking band is arranged on the hypotube between the diffusion stress tube and the proximal coating.

8. The balloon catheter according to claim 1, characterized in that, The hypotube is a single-layer metal hollow tube, the surface of which is coated with a hydrophobic coating, and the hypotube close to the balloon is a variable-density spiral or "hollow" straight or S-shaped strip wire.

9. The balloon catheter according to claim 1, characterized in that, A developing ring is arranged on the inner tube located in the effective length area of ​​the balloon.

10. The balloon catheter according to claim 9, characterized in that, The number of the developing rings is 1 or 2.

11. The balloon catheter according to claim 9, characterized in that, The developing circle is a continuous developing circle or an intermittent developing circle.

12. The balloon catheter according to claim 9, wherein, The developing ring is a spring ring made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy or gold.

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