CN115227470A - Balloon catheter - Google Patents

Abstract

The present disclosure provides a balloon catheter comprising: a balloon; the inner tube is arranged in the balloon and comprises an inner layer, an outer layer and a middle layer, the middle layer is used for bonding the inner layer and the outer layer, and the outer layer is made of one or more of the following materials: polyether amide block copolymers, nylon or polyurethane; the guide wire port is communicated with the inner tube and is arranged at one end of the balloon; a tip tube formed at the other end of the balloon and connected to the balloon; the hypotube is connected with one end of the saccule in the direction away from the guide wire opening through a connecting pipe. The balloon catheter can ensure the use safety and solve the problems of poor near-end controllability and trafficability and insufficient collapse resistance of the inner tube in the conventional balloon catheter.

Description

Balloon catheter

Technical Field

The disclosure relates to the field of medical equipment, in particular to a balloon catheter.

Background

Common vascular diseases include ischemic stenosis and hemorrhagic aneurysm. The disease causing ischemic stenosis is caused by atherosclerosis to cause vascular stenosis, and blood supply is influenced. The main means for clinically solving the diseases comprise surgical bypass and minimally invasive intervention operation. With the popularization of minimally invasive intervention medicine, the technical progress of medical instruments, the improvement of national consciousness, small trauma, short operation time, quick postoperative recovery, low operation risk and cost and other advantages, the minimally invasive intervention gradually replaces the traditional surgical operation and is rapidly developed. The balloon catheter plays a critical role in the operation process as a balloon catheter in the minimally invasive interventional operation process. The combined operation requirements include pure balloon dilatation and combined use of the balloon and a stent or other apparatuses. By means of the assistance of medical imaging equipment, a blood vessel passage is established through an artery puncture and a guide catheter, and if the calcified lesion is light, the calcified lesion can be expanded by adopting a pure balloon catheter. If the calcified lesion is serious, a stent needs to be placed, a balloon catheter is firstly used for pre-expanding the calcified part, then the balloon catheter holding the stent is pressed, the stent is slowly opened and released along with the filling of the balloon, and finally the balloon catheter and operation supporting equipment are withdrawn. In conjunction with clinical blood supply, further assessment was made as to whether post-balloon dilatation was required. The stent staying in the blood vessel can provide effective support for the blood vessel, and the purpose of stenotic lesion is realized.

Most common balloons in the market adopt a single-layer tube design, and the situation of insufficient pressure resistance is easy to occur when clinical severe calcified lesions are encountered; the inner layer pipe is designed by adopting two layers or three layers of high polymer materials, when calcified lesions are positioned at tortuous vessels or blood vessel intersections, the inner layer pipe does not have good flexibility, the problem of 'folding' exists, and meanwhile, when the high-pressure requirement is met, the inner layer pipe cannot provide effective support and is easy to cause 'collapse'; the spiral design of the far end of the single-layer metal hypotube with the hollow design is unreasonable, so that the hardness of the catheter cannot be smoothly transited, and the integral trafficability of the balloon catheter is poor; the single-cavity pipes with various hardnesses are connected into a whole through laser welding, so that the working procedures are increased, and the production efficiency and the production cost are influenced.

Disclosure of Invention

The present disclosure provides a balloon catheter, which can solve one or more problems of poor proximal maneuverability and passability, insufficient collapse resistance of an inner tube, and the like of the balloon catheter mentioned in the background art. In order to solve the above technical problem, the present disclosure provides a balloon catheter, comprising:

a balloon;

the inner tube is arranged in the balloon and comprises an inner layer, an outer layer and a middle layer, the middle layer is used for bonding the inner layer and the outer layer, and the outer layer is made of one or more of the following materials: polyether amide block copolymers, nylon or polyurethane;

the guide wire port is communicated with the inner tube and is arranged at one end of the balloon;

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

the hypotube is connected with one end of the saccule in the direction away from the guide wire opening through a connecting pipe.

Optionally, the inner layer material is high-density polyethylene or modified etched polytetrafluoroethylene.

Optionally, the intermediate layer material is a modified low density polyethylene and/or a linear low density polyethylene.

Optionally, the tip tube comprises an inner tip layer and an outer tip layer, the outer diameter of the outer tip layer gradually decreases away from the balloon.

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

Optionally, the balloon includes two end shoulders in contact with the inner tube and the tip tube and an effective balloon length region intermediate the two end shoulders.

Optionally, the balloon is a single-layer balloon, the two end shoulders are made of polyurethane, and the effective length area of the balloon is made of polyether amide block copolymer or nylon;

or the saccule is a double-layer saccule, the saccule comprises a saccule inner layer and a saccule outer layer, the saccule inner layer is made of polyether amide block copolymer or nylon, and the saccule outer layer is made of polyurethane;

or the saccule is a three-layer saccule and comprises a saccule inner layer, a saccule middle layer and a saccule outer layer, wherein the saccule inner layer is made of polyether amide block copolymer or nylon, and the saccule outer layer is made of polyurethane.

Optionally, the shoulder taper distal to the tip tube is less than the shoulder taper proximal to the tip tube;

and/or the other end of the hypotube far away from the balloon direction is connected with one end of a diffusion stress tube, and the other end of the diffusion stress tube is connected with a catheter seat;

and/or the surface of a connecting pipe between the guide wire port and the balloon is coated with a distal end coating;

and/or a near-end coating is coated on the hypotube far away from the direction of the wire guide port, and a mark belt is arranged on the hypotube between the diffusion stress tube and the near-end coating;

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 linear or S-shaped strip wire with variable density spiral or hollow; or, the hypotube comprises a hypotube inner layer and a hypotube outer layer, the hypotube inner layer adopts stainless steel or nickel titanium metal wires, is in a spiral twisted shape, the surface of the hypotube inner layer contains a polytetrafluoroethylene or parylene coating, the hypotube outer layer contains one or the combination of a polyether amide block copolymer or polyurethane, and the surface of the hypotube outer layer contains one or the combination of a polyvinylpyrrolidone or a hyaluronic acid coating; or, the hypotube comprises a hypotube inner layer, a hypotube outer layer and a hypotube middle layer, the hypotube inner layer is made of modified etched polytetrafluoroethylene or high-density polyethylene, the hypotube outer layer is made of a high polymer material, one or a combination of nylon and polyether amide block copolymers is adopted, the material hardness of the hypotube far away from the balloon direction is higher than that of the hypotube close to the balloon direction, and the hypotube middle layer is made of stainless steel or nickel-titanium metal wires.

Optionally, an image circle is arranged on the inner tube in the effective length area of the balloon.

Optionally, the number of circles of development is 1 or 2;

or the developing ring is a continuous developing ring or an intermittent developing ring;

and/or the developing ring is a spring ring made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy or gold.

The beneficial effects of this disclosure are:

1) The outer layer material of the inner tube adopts one or the combination of polyether amide block copolymer (PEBAX), NYLON (NYLON) and Polyurethane (PU) for improving the tensile strength and the elongation at break of the tube and ensuring the use safety, and the inner layer material of the inner tube is one of High Density Polyethylene (HDPE) with lower friction coefficient and modified etching polytetrafluoroethylene (e-PTFE) for reducing the pushing resistance of a guide wire or other instruments in the inner cavity. The inner tube interlayer material is one or the combination of modified Low Density Polyethylene (LDPE) and Linear Low Density Polyethylene (LLDPE), and is used for bonding the polar outer layer and the nonpolar inner layer to avoid delamination.

2) The balloon adopts a multi-layer balloon structure design, one of a double layer or a three layer is selected preferably, the hardness of the balloon material is reduced from inside to outside, the high-hardness inner layer ensures the pressure resistance of the balloon, the low-hardness outer layer ensures the flexibility, and the tearing of the inner wall of the target blood vessel is reduced.

3) The external diameter of the tip tube adopts the design of gradual taper, thereby improving the trafficability characteristic and reducing the fish mouth effect.

Drawings

Fig. 1 is a schematic view of the overall structure of a balloon catheter;

FIG. 2 is a schematic cross-sectional view of a tip tube of a balloon catheter;

FIG. 3 is a schematic view of the design of the distal helical hypotube in a balloon catheter;

FIG. 4 is a schematic structural view of a distal hollow hypotube design in a balloon catheter;

FIG. 5 is a schematic diagram of a torsion spring hypotube design in a balloon catheter;

FIG. 6 is a schematic view of the inner tube braided profile in a balloon catheter;

FIG. 7 is a schematic cross-sectional view of the inner tube spring in the balloon catheter;

FIG. 8 is a schematic view of a balloon cross-sectional configuration in a balloon catheter;

fig. 9 is a schematic view of a diffuse stress tube configuration in a balloon catheter.

Wherein the figures are numbered as:

1-a tip tube; 2-a balloon; 3-developing circle; 4-inner tube; 5-distal coating; 6-a hypotube; 7-diffusion stress tube; 8-a catheter hub; 9-connecting pipe; 10 a proximal coating; 11-a guide wire port; 12-marker band.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

The present disclosure provides a balloon catheter, as shown in fig. 1-9, comprising:

a balloon 2;

an inner tube 4 disposed inside the balloon 2, as shown in fig. 6-7, the inner tube 4 includes an inner layer 4a, an outer layer 4c and an intermediate layer 4b, the intermediate layer 4b is used for bonding the inner layer 4a and the outer layer 4c, and the material of the outer layer 4c is one or more of the following materials: polyether amide block copolymers, nylon or polyurethane; the tensile strength and the elongation at break of the pipe are improved, and the use safety is ensured;

the guide wire port 11 is communicated with the inner tube 4 and is arranged at one end of the balloon 2;

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

and the hypotube 6 is connected with one end of the saccule 2 in the direction away from the guide wire port 11 through a connecting pipe 9. The connecting pipe 9 is made of a two-component mixture of NYLON (NYLON), polyether-amide block copolymer (PEBAX) and Polyurethane (PU). The connecting pipe 9 realizes smooth transition connection of the hypotube and the balloon through one or the combination of thermal shrinkage or laser welding.

In some embodiments, the inner layer 4a is made of high density polyethylene or modified etched polytetrafluoroethylene, and is used for reducing the pushing resistance of a guide wire or other instruments in the inner cavity.

In some embodiments, the material of the middle layer 4b is a modified low density polyethylene, in some embodiments a linear low density polyethylene, for bonding the polar outer layer and the non-polar inner layer to avoid delamination. The material of the intermediate layer is one or the combination of medical materials such as polymer fiber wires, stainless steel wires, nickel-titanium wires, huang Jinsi, platinum-nickel wires, platinum-tungsten wires and the like; wire shapes include, but are not limited to, one of round or rectangular wires; the middle layer adopts one or the combination of a weaving design or a spiral spring design, and the weaving or the spiral spring adopts one or the combination of a constant pitch design or a variable pitch design.

In some embodiments, the tip tube 1 includes an inner tip layer and an outer tip layer, the outer diameter of the outer tip layer tapering away from the balloon 2. The shore hardness of the further outer layer material is preferably 40A-55D. The outer diameter of the tip adopts a design of gradual taper, so that the trafficability characteristic is improved, and the fish mouth effect is reduced.

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

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 area of the balloon 2 intermediate the two end shoulders.

In some embodiments, the balloon 2 is a single-layer balloon, the two end shoulder portions are made of polyurethane, and the effective length area of the balloon 2 is made of polyether amide block copolymer or nylon; the material pipe for forming the balloon 2 adopts one of continuous extrusion, injection molding or melting seamless welding processing.

In some embodiments, the balloon 2 is a double-layer balloon, the balloon 2 comprises a balloon inner layer and a balloon outer layer, the balloon 2 inner layer is made of polyether amide block copolymer or nylon, and the balloon 2 outer layer is made of polyurethane; furthermore, the hardness of the sacculus material is reduced from inside to outside, the inner layer with high hardness ensures the pressure resistance of the sacculus, and the outer layer with low hardness ensures the flexibility and reduces the tearing of the inner wall of the target blood vessel.

In some embodiments, the balloon 2 is a three-layer balloon, the balloon 2 comprises a balloon inner layer, a balloon middle layer and a balloon outer layer, the balloon inner layer is made of polyether amide block copolymer or nylon, and the balloon outer layer is made of polyurethane.

In some embodiments, the shoulder taper distal to the tip tube 1 is less than the shoulder taper proximal to the tip tube 1; the taper angle of the far end shoulder of the saccule 2 is 10 degrees to 30 degrees, and the taper angle of the near end shoulder of the saccule 2 is 15 degrees to 45 degrees. Furthermore, the taper of the far end shoulder of the balloon 2 is smaller than that of the near end shoulder, so that the passing performance of the balloon catheter is improved, the inflating and decompressing time is reduced, and the operation time is shortened. The modification mode of the balloon 2 includes one of plasma treatment, surface etching treatment and surface grafting treatment.

In some embodiments, the other end of the hypotube 6, which is away from the balloon 2, is connected with one end of a diffusion stress tube 7, and the other end of the diffusion stress tube 7 is connected with a catheter hub;

in some embodiments, the connecting tube 9 between the guidewire port 11 and the balloon 2 is surface coated with a distal coating 5;

in some embodiments, a proximal coating is applied to the hypotube 6 away from the guidewire port 11, and marker bands 12 are disposed on the hypotube 6 between the diffusive 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 is designed in a variable-pitch hollow-out structure.

In some embodiments, the hypotube 6 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 6 close to the balloon 2 is a linear or S-shaped strip wire with variable density spiral or "hollow".

In some embodiments, the hypotube 6 comprises 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, the surface of the hypotube inner layer contains a polytetrafluoroethylene or parylene coating, the hypotube outer layer contains one or a combination of a polyether amide block copolymer or polyurethane, and the surface of the hypotube outer layer contains one or a combination of a polyvinyl pyrrolidone or a hyaluronic acid coating.

In some embodiments, the hypotube 6 includes a hypotube inner layer 6a, a hypotube outer layer 6c, and a hypotube intermediate 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 polyether amide block copolymer or a combination thereof, the hypotube outer layer 6c away from the balloon 2 has a material hardness greater than that of the hypotube outer layer close to the balloon 2, and the hypotube intermediate layer 6b is made of stainless steel or nickel titanium wire. For example, wire shapes include, but are not limited to, one or a combination of round wires, rectangular wires; the metal wires in the middle layer adopt a variable density spiral braiding mode, and the braiding density PPI = 100-300.

In some embodiments, a developing ring 3 is disposed on the inner tube 4 in the region of the effective length of the balloon 2. The developing ring 3 is embedded on the inner tube or is positioned in the middle layer of the inner tube and is used for marking the position of the saccule in the blood vessel and assisting the measurement of the length of the lesion.

In some embodiments, the number of said development circles 3 is 1 or 2;

in some embodiments, the development circle 3 is a continuous development circle 3 or an intermittent development circle 3; the two ends of the length of the continuous developing spring ring are designed by adopting compact spring winding, the length of the spring winding is 0.5-1.5 mm, the middle area is designed by adopting interval spring winding, one or the combination of equal pitch and variable pitch is adopted, and the length is changed along with the change of the effective length of the saccule.

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

Specific examples are given below to illustrate the above embodiments:

example 1

The diffusion stress tube 7 in this embodiment is designed to have a Polyamide (PA) variable pitch "hollow" structure a, and is fixed to the catheter hub 8 in an inverted manner. The tip tube 1 is designed as a two-layer structure, with an inner layer of etched polytetrafluoroethylene (e-PTFE) and an outer layer of a polyetheramide block copolymer (PEBAX 4033). The balloon 2 is designed in a single-layer structure, the shoulders at the two ends of the balloon are made of Polyurethane (PU), the effective length of the balloon is made of polyether amide block copolymer (PEBAX 6333), and a balloon material pipe is formed by melting and seamless welding forming. The taper angle of the shoulder at the far end of the saccule is 15 degrees, and the taper angle of the shoulder at the near end of the saccule is 30 degrees. The surface of the balloon is treated by plasma, and the outer surface of the balloon contains hydrophilic coating PVP. The pipe 9 used was a blend of 1:1 nylon (PA 12) and a polyetheramide block copolymer (PEBAX 7233). The hypotube 6 selects a medical 304 stainless steel single-layer metal hollow tube, the far end of the hollow tube adopts a variable pitch design, the far end binding section comprises an extended straight wire, and the surface of the hollow tube comprises a Polytetrafluoroethylene (PTFE) coating. The inner tube 4 is designed as a three-layer structure, with an inner layer of High Density Polyethylene (HDPE), a middle layer of modified Low Density Polyethylene (LDPE), and an outer layer of a polyether amide block copolymer (PEBAX 7233). The developing ring 3 is a platinum-iridium alloy spring ring with the length of 0.5 mm. The inner tube 4 is positioned in the middle of the effective length area of the balloon 2 or the pins at the two ends of the inner tube contain 1 or 2 developing rings 3. The outer layer of inner tube development circle 3 department forms the concavity through mechanical or laser processing, guarantees that development circle 3 effectively imbeds the depressed part through the mechanical pressure mode of holding, and the outer level that keeps of non-depressed area.

Example 2

In contrast to example 1, the diffusion stress tube 7 in this example uses High Density Polyethylene (HDPE). The tip tube 1 has an inner layer of etched polytetrafluoroethylene (e-PTFE) and an outer layer of polyurethane (Pallet thane2363-80 AE). The balloon 2 is designed by adopting a double-layer structure, the inner layer of the balloon is polyether amide block copolymer (PEBAX 7233), and the outer layer of the balloon is polyurethane (Pallenthane 2363-80 AE). The hypotube 6 is designed to be a double-layer structure, the material of the hypotube is stainless steel round wire, the hypotube is designed to be twisted spirally, and the surface of the metal wire contains a Polytetrafluoroethylene (PTFE) coating; the outer layer of the hypotube is polyether amide block copolymer (PEBAX 4033) with lower hardness, and the surface of the outer layer material contains polyvinylpyrrolidone (PVP). The inner tube 4 is designed to be a three-layer structure, wherein the inner layer material is etched polytetrafluoroethylene (e-PTFE); the middle layer is a platinum-tungsten spring ring with variable pitch, the two ends of the spring ring adopt a tight spring winding mode, the length is 0.6mm, and the outer layer is polyether amide block copolymer (PEBAX 7033).

Example 3

In contrast to example 1, the tip tube 1 had an inner layer of etched polytetrafluoroethylene (e-PTFE) and an outer layer of polyurethane (TT-1085A). The balloon 2 is designed to have a three-layer structure, the inner layer of the balloon is polyether amide block copolymer (PEBAX 7233), the middle layer of the balloon is polyether amide block copolymer (PEBAX 7033), and the outer layer of the balloon is polyurethane (Pallenthane 2363-80 AE). The pipe 9 used was a polyetheramide block copolymer (PEBAX 7233) and polyurethane (Pallenthane 2363-80 AE) in a weight mixing ratio of 2:1. The hypotube 6 is a medical 316 stainless steel single-layer metal hollow tube, the far end of the hollow tube adopts a variable-pitch design, the far-end binding section comprises extended S-shaped wires, and the outer surface of the metal is coated with a hydrophobic Parylene coating. The inner tube 4 is designed to be a three-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), the middle layer is polymer fiber yarn, and the outer layer is polyether amide block copolymer (PEBAX 7033). The developing ring 3 adopts a gold spring ring with the length of 0.8 mm. The inner tube 4 is located in the middle of the length of the effective area of the balloon 2 or the pins at two ends of the inner tube contain 1 or 2 developing rings 3, and is embedded in the concave part of the embedded inner tube as in embodiment 1.

Example 4

In contrast to example 1, the diffusion stress tube 7 in this example uses 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 (Pallenthane 2363-80 AE). The balloon 2 is designed by adopting a double-layer structure, the inner layer of the balloon is polyether amide block copolymer (PEBAX 7033), and the outer layer of the balloon is polyurethane (TT-1085A). The connection pipe 9 uses a polyether amide block copolymer (PEBAX 7033) and polyurethane (TT-1085A) in a weight mixing ratio of 2:1. The hypotube 6 is designed in a three-layer structure, the inner layer of the hypotube is made of etched polytetrafluoroethylene (e-PTFE), the middle layer of the hypotube is made of medical 304 stainless steel and nickel titanium round wires, a variable density spiral weaving mode is adopted, and the weaving density of the proximal end of the hypotube is larger than that of the distal end. The outer layer of the hypotube is polyether amide block copolymer (PEBAX 7433). The inner tube 4 is the bilayer structure design, and wherein the inlayer is High Density Polyethylene (HDPE), and the intermediate level is the nickel titanium spring circle of variable pitch design, and the spring circle both ends adopt closely around the spring mode, and length is 0.8mm, and the skin is polyether amide block copolymer (PEBAX 7033).

Example 5

In contrast to example 1, the tip tube 1 had an inner layer of etched polytetrafluoroethylene (e-PTFE) and an outer layer of polyurethane (TT-1085A). The balloon 2 is designed to be of a three-layer structure, the inner layer of the balloon is made of polyamide (PA 12), the middle layer of the balloon is made of polyether amide block copolymer (PEBAX 7033), and the outer layer of the balloon is made of polyurethane (TT-1085A). The pipe 9 was made of polyamide (PA 12) and polyurethane (TT-1085A) in a weight mixing ratio of 3:2. The hypotube 6 is designed to be a double-layer structure, the material of the hypotube is medical nickel titanium rectangular wire, the hypotube is designed to be twisted spirally, and the surface of the metal wire contains Parylene (Parylene) coating; the outer layer of the hypotube is polyurethane (TT-1085A) with lower hardness, and the surface of the outer layer material contains a Hyaluronic Acid (HA) coating. The inner tube 4 is designed to be a three-layer structure, wherein the inner layer is etched polytetrafluoroethylene (e-PTFE), and the middle layer adopts a constant-pitch weaving mode. The development ring 3 is a platinum-iridium alloy spring ring with the length of 1.0mm, and is embedded in the concave part of the embedded inner pipe as in the embodiment 1.

Example 6

Compared with the embodiment 1, the balloon 2 in the embodiment adopts a double-layer structure design, the inner layer of the balloon is made of polyamide (PA 12), and the outer layer of the balloon is made of polyurethane (Pallenthane 2363-80 AE). The taper angle of the balloon distal shoulder is 20 degrees, and the taper angle of the balloon proximal shoulder is 25 degrees. The surface of the balloon is etched, and the outer surface of the balloon contains hydrophilic coating PVP. The pipe 9 used a polyetheramide block copolymer (PEBAX 7233) and polyurethane (Pallenthane 2363-80 AE) in a weight mixing ratio of 1:1. The hypotube 6 selects a medical 304 stainless steel single-layer metal hollow tube, the far end of the hollow tube adopts a variable-pitch 'hollow' design, the end section of the far end contains an extended straight wire, and the surface of the far end contains a Polytetrafluoroethylene (PTFE) coating. The inner tube 4 is designed to be a three-layer structure, wherein the inner layer is high-density polyethylene (HDPE), the middle layer is polymer fiber yarn, the design of a variable-pitch helical spring is adopted, and the outer layer is polyether amide block copolymer (PEBAX 7033). The developing ring 3 is a platinum-tungsten alloy spring ring with the length of 1.0 mm. The inner tube 4 is located at the two ends of the length of the effective area of the saccule 2, and the pins of the two ends contain 2 developing rings 3. The embedded inner tube is embedded in the concave part of the embedded inner tube as in the embodiment 1.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all changes in equivalent structure and equivalent flow path changes made by the contents of the present specification and drawings, which are directly or indirectly applied to other related technical fields, are intended to be embraced by the present invention without departing from the spirit of the present invention.

Although embodiments of the present disclosure have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations may be made in these embodiments without departing from the principles and spirit of the disclosure, the scope of which is defined in the appended claims and their equivalents.

Claims (10)

1. A balloon catheter, comprising:

a balloon;

the inner tube is arranged in the balloon and comprises an inner layer, an outer layer and a middle layer, the middle layer is used for bonding the inner layer and the outer layer, and the outer layer is made of one or more of the following materials: polyether amide block copolymers, nylon or polyurethane;

the guide wire port is communicated with the inner tube and is arranged at one end of the balloon;

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

and the hypotube is connected with one end of the saccule in the direction away from the guide wire port through a connecting pipe.

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

3. A balloon catheter according to claim 1 or 2, wherein the intermediate layer material is a modified low density polyethylene and/or a linear low density polyethylene.

4. A balloon catheter according to claim 1 or claim 2, wherein the tip tube includes an inner tip layer and an outer tip layer, the outer diameter of the outer tip layer tapering away from the balloon.

5. A balloon catheter according to claim 4, wherein the tip inner layer material is high density polyethylene or etched polytetrafluoroethylene; the Shore hardness of the tip outer layer material is 40A-55D.

6. A balloon catheter according to claim 1, wherein the balloon includes two end shoulders in contact with the inner tube and the tip tube and a balloon effective length area intermediate the two end shoulders.

7. A balloon catheter according to claim 6, wherein the balloon is a single-layer balloon, the two end shoulder portions are made of polyurethane, and the balloon effective length area is made of polyether amide block copolymer or nylon;

or the saccule is a double-layer saccule, the saccule comprises a saccule inner layer and a saccule outer layer, the saccule inner layer is made of polyether amide block copolymer or nylon, and the saccule outer layer is made of polyurethane;

or the saccule is a three-layer saccule and comprises a saccule inner layer, a saccule middle layer and a saccule outer layer, wherein the saccule inner layer is made of polyether amide block copolymer or nylon, and the saccule outer layer is made of polyurethane.

8. The balloon catheter of claim 6 wherein the shoulder taper distal to the tip tube is less than the shoulder taper proximal to the tip tube;

and/or the other end of the hypotube far away from the balloon direction is connected with one end of a diffusion stress tube, and the other end of the diffusion stress tube is connected with a catheter seat;

and/or the surface of a connecting pipe between the guide wire port and the balloon is coated with a distal end coating;

and/or a near-end coating is coated on the hypotube far away from the direction of the wire guide port, and a mark belt is arranged on the hypotube between the diffusion stress tube and the near-end coating;

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 linear or S-shaped strip wire with variable density spiral or hollow; or, the hypotube comprises a hypotube inner layer and a hypotube outer layer, the hypotube inner layer adopts stainless steel or nickel titanium metal wires, is in a spiral twisted shape, the surface of the hypotube inner layer contains a polytetrafluoroethylene or parylene coating, the hypotube outer layer contains one or the combination of a polyether amide block copolymer or polyurethane, and the surface of the hypotube outer layer contains one or the combination of a polyvinylpyrrolidone or a hyaluronic acid coating; or, the hypotube comprises a hypotube inner layer, a hypotube outer layer and a hypotube middle layer, the hypotube inner layer is made of modified etched polytetrafluoroethylene or high-density polyethylene, the hypotube outer layer is made of a high polymer material, one or a combination of nylon and polyether amide block copolymers is adopted, the material hardness of the hypotube outer layer far away from the saccule direction is higher than that of the hypotube close to the saccule direction, and the hypotube middle layer is made of stainless steel or nickel-titanium metal wires.

9. A balloon catheter according to claim 6 wherein the inner tube in the region of the effective length of the balloon is provided with an image circle.

10. The balloon catheter of claim 9, wherein the number of said visualization circles is 1 or 2;

or the developing ring is a continuous developing ring or an intermittent developing ring;

and/or the developing ring is a spring ring made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy or gold.

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