Woven reinforced polyether-ether-ketone composite conduit capable of being continuously produced as well as processing method and application of braided reinforced polyether-ether-ketone composite conduit

Abstract

The invention discloses a woven reinforced polyether-ether-ketone composite conduit capable of being continuously produced and a processing method and application thereof, the woven reinforced polyether-ether-ketone composite conduit comprises an inner-layer pipe, a middle woven layer and an outer-layer pipe structure, and the inner-layer pipe, the middle woven layer and the outer-layer pipe structure are all made of polyether-ether-ketone; and the outer-layer pipe structure is formed outside the inner-layer pipe and the middle woven layer through a dip-coating process. The invention has the following advantages and effects: the scheme utilizes a new mechanical structure, and has the effects of facilitating continuous industrial production, improving the processing efficiency, reducing the economic burden of a patient, prolonging the service life and effectively improving the overall bending performance of the composite conduit.

Description

Technical Field

[0001] The present invention relates to the technical field of medical catheters, and in particular to a braided reinforced polyetheretherketone composite catheter capable of continuous production, and a processing method and application thereof. Background Art

[0002] In the medical device industry, medical catheters usually include an inner tube and an outer tube. With the advancement of medical technology, the existing technology has added a layer of braided tube between the inner tube and the outer tube. This braided tube usually uses metal braided wire for mesh weaving. By weaving the metal braided wire into the inside of the medical catheter, the support strength of the tube body can be strengthened, the pushing and introduction performance can be improved, and it also has a certain degree of bending resistance.

[0003] Since medical catheter intervention surgery has a small trauma area and fast wound recovery, this intervention surgery has become the preferred choice for surgical treatment for more and more patients. Medical catheters are usually produced in sections, that is, the inner tube, braided tube and outer tube are first processed and produced separately, and then the braided tube is sleeved outside the inner tube, and finally the outer tube is tightly wrapped around the braided tube by heat shrink technology, so that the three-layer tube structure is tightly connected to each other to obtain the final medical catheter product. This production method of segmented medical catheters has the following defects: 1. The three-layer tube structure of this segmented medical catheter needs to be produced separately, and then assembled into a medical catheter product. The production efficiency of this medical catheter is slow, and it is difficult to produce a long-length medical catheter; 2. With the surge in the number of patients using medical catheters, medical catheters are often in short supply, resulting in high prices, which greatly increases the financial burden on patients; 3. The outer tube of the existing three-layer composite catheter is produced and processed separately, and needs to be put on the inner tube and the braided tube later. It needs sufficient structural strength, resulting in a thick outer tube, which makes the overall outer diameter of the medical catheter prepared by the outer tube larger, affecting the overall bending performance of the medical catheter; 4. In the existing composite catheter, usually only the inner tube or the outer tube is made of polyetheretherketone material, and the middle braided tube is usually woven with metal wires. The braided tube made of metal material has poor fatigue resistance. After repeated bending, the metal wire is prone to elastic fatigue and damage. Summary of the invention

[0004] The purpose of the present invention is to provide a braided reinforced polyetheretherketone composite catheter that can be continuously produced, and a processing method and application thereof, which are beneficial to continuous industrial production to improve processing efficiency, reduce the economic burden on patients, extend service life, and effectively improve the overall bending performance of the composite catheter.

[0005] The above technical purpose of the present invention is achieved through the following technical scheme: a braided reinforced polyetheretherketone composite conduit that can be continuously produced, including an inner tube, an intermediate braided layer and an outer tube structure, the materials of the inner tube, the intermediate braided layer and the outer tube structure are all made of polyetheretherketone, and the outer tube structure is formed on the outside of the inner tube and the intermediate braided layer by a dip coating process.

[0006] By adopting the above technical scheme, the inner tube, the middle braided layer and the outer tube structure are all set to polyetheretherketone materials. By utilizing the excellent chemical stability and creep resistance of polyetheretherketone itself, the composite catheter made of three layers of polyetheretherketone material can withstand repeated bending, thereby extending the service life of the composite catheter. At the same time, polyetheretherketone has excellent biocompatibility, which can reduce the rejection reaction between the composite catheter and the human body. In addition, the polyetheretherketone melt has high melt thermal stability, and the melted polyetheretherketone has melt fluidity. During production and processing, the polyetheretherketone fiber filaments are first woven into the middle braided layer on the outer wall of the inner tube, and then the inner tube with the polyetheretherketone fiber filaments wrapped around the outer surface is used as the base. The present invention uses a three-layer polyetheretherketone material to form an outer tube structure formed of a polyetheretherketone material on the surface of the substrate by a dip coating process. The outer tube structure formed on the outer surface of the substrate by the dip coating process can be made thinner and lighter, ensuring that the composite catheter has sufficient supporting performance while effectively improving the bending performance of the composite catheter. The structural characteristics of the composite catheter made of the three-layer polyetheretherketone material can realize industrial continuous production, thereby improving production and processing efficiency, and then reducing the price of the composite catheter on the market by increasing output, reducing the economic burden on patients, and having the effect of being conducive to continuous industrial production to improve processing efficiency, reduce the economic burden on patients, extend service life, and effectively improve the overall bending performance of the composite catheter.

[0007] The present invention provides a processing method for producing a composite conduit, comprising the following steps: S1: Inner tube preparation, including the following steps: S101: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S102: extrusion molding: heating the polyetheretherketone pellets to a molten state, and extruding them through an extruder to form a hollow inner tube; S103: Cooling and shaping: cooling and shaping the inner tube after extrusion through a cooling device; S104: Surface treatment: Mechanically polish the outer wall of the inner tube to increase the friction of the outer surface of the inner tube, thereby improving the bonding force between the outer surface of the inner tube and the middle braided layer; S2: Preparation of the intermediate braided layer, including the following steps: S201: Raw material preparation: Polyetheretherketone fiber yarn is selected as the weaving material; S202: Weaving and forming: positioning the inner tube prepared in S1 on a three-dimensional weaving machine, weaving the polyetheretherketone fiber filaments on the outer wall of the inner tube by the three-dimensional weaving machine to form an intermediate braided layer; S3: Preparation of outer tube structure, including the following steps: S301: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S302: Melting: heating the polyetheretherketone particles in the heating kettle to melt them into a molten adhesive state, and maintaining the polyetheretherketone in the heating kettle in a molten adhesive state by continuous heating to obtain a polyetheretherketone molten adhesive; S303: Impregnation: vertically place the inner tube wrapped with the middle braided layer as the base material into the heating kettle to fully impregnate it with the polyetheretherketone melt; S304: pulling: pulling the substrate, by adjusting the balance between the viscosity of the polyetheretherketone melt and the pulling speed to ensure that the polyetheretherketone melt surface does not vibrate, thereby forming a polyetheretherketone film of uniform thickness and continuity on the surface of the substrate; S305: degassing: after the pulling is completed, the substrate with the polyetheretherketone film on the surface is placed in a heating degassing device in a rotating state for drying and heating to remove bubbles in the polyetheretherketone melt attached to the surface of the substrate; S306: Curing: The temperature in the heating and defoaming device is uniformly and slowly lowered until the polyetheretherketone melt is solidified on the surface of the substrate and forms a uniform film, and finally an outer tube structure is formed outside the inner tube and the middle braided layer.

[0008] By adopting the above technical scheme, the present invention prepares the inner tube through the first process, and then after grinding the outer surface of the inner tube, the inner tube is moved to the second process, and the middle braided layer is formed by three-dimensional weaving outside the inner tube through the second process. At the same time, the polyetheretherketone particles are pre-melted in a heating kettle in the third process to form a polyetheretherketone melt. After that, the inner tube wrapped with the middle braided layer obtained in the second process is put into the heating kettle as a substrate, and a layer of polyetheretherketone outer tube structure is formed by coating the outer surface of the substrate through dipping and pulling steps. Finally, the polyetheretherketone melt coated on the outer surface of the substrate is solidified on the outer surface of the substrate in a bubble-free state with equal thickness through degassing and curing steps, and finally a composite conduit made of three-layer polyetheretherketone pipe is formed, thereby realizing the continuous processing and production of the polyetheretherketone composite conduit of the present invention.

[0009] The present invention is further configured as follows: in step S103, the cooling device is configured as a cooling water tank.

[0010] By adopting the above technical solution, the inner tube extruded by the extruder is pulled into the circulating water in the cooling water tank, and the inner tube is cooled by the circulating water to complete the cooling and shaping of the inner tube.

[0011] The present invention is further configured as follows: the diameter of the polyetheretherketone fiber filament in step S201 is set between 50-200 microns.

[0012] The present invention is further configured as follows: in step S302, the heating temperature of the heating kettle is maintained between 330-400°C.

[0013] By adopting the above technical scheme, since the melting temperature of polyetheretherketone is 334°C and the thermal weight loss can be guaranteed to be zero below 400°C, and polyetheretherketone will undergo phase change after exceeding 400°C, affecting the coating effect of the polyetheretherketone molten adhesive, the heating temperature of the heating kettle is maintained between 330-400°C, which can ensure that the polyetheretherketone in the reactor is always kept in a molten adhesive state, and at the same time, it is also beneficial to precipitate and discharge the bubbles in the polyetheretherketone molten adhesive.

[0014] The present invention is further configured as follows: the viscosity of the polyetheretherketone melt in step S304 is maintained between 350-480 Pa·s, and the pulling speed is controlled between 0.1-10 mm / min.

[0015] By adopting the above technical solution, it is ensured that the polyetheretherketone melt surface does not vibrate, so that a polyetheretherketone film of uniform thickness and continuity is formed on the surface of the substrate.

[0016] The present invention is further configured as follows: in step S305, the defoaming temperature of the heating defoaming device is controlled between 110-130° C., the internal pressure of the heating defoaming device is controlled between 1 KPa-80 kPa, and the defoaming time is controlled between 1-4 hours.

[0017] By adopting the above technical solution, it is ensured that the polyetheretherketone melt coated on the outer surface of the substrate will not contain bubbles.

[0018] The present invention is further configured as follows: the cooling rate of the heating and defoaming device in step S306 is controlled at 0.5-1°C / min.

[0019] By adopting the above technical solution, the heating and degassing device is controlled to cool down slowly and evenly, which is conducive to making the polyetheretherketone melt solidify evenly on the outer surface of the substrate and preventing the polyetheretherketone melt from forming crack defects when solidifying on the outer surface of the substrate.

[0020] The present invention is further configured as follows: a rotating clamping device is provided in the heating and degassing device, and the rotating clamping device is used to drive the substrate horizontally placed in the heating and degassing device and coated with the polyetheretherketone melt to rotate at a uniform speed during heating.

[0021] By adopting the above technical solution, the concentricity of the polyetheretherketone melt coated on the outer surface of the substrate is ensured during the degassing process, and the polyetheretherketone melt is prevented from dripping from the surface of the base material due to gravity during the degassing process.

[0022] The invention provides an application of a composite catheter. The composite catheter of the invention is used for preparing materials for interventional treatment instruments for cardiovascular diseases.

[0023] In summary, the present invention has the following beneficial effects: Polyetheretherketone fiber filaments are woven on the outer wall of the inner tube to form an intermediate woven layer, and then the inner tube with polyetheretherketone fiber filaments wrapped on the outer surface is used as a substrate, and an outer tube structure formed of polyetheretherketone material is formed on the surface of the substrate by a dip-coating process. The outer tube structure formed on the outer surface of the substrate by the dip-coating process can be made thinner, ensuring that the composite catheter has sufficient supporting performance while effectively improving the bending performance of the composite catheter. The structural characteristics of the composite catheter made of three-layer polyetheretherketone material in the present invention can realize industrial continuous production, thereby improving production and processing efficiency, and then reducing the price of composite catheters on the market by increasing output, reducing the economic burden on patients, which is beneficial to continuous industrial production to improve processing efficiency, reduce the economic burden on patients, extend service life, and effectively improve the overall bending performance of the composite catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a longitudinal cross-sectional view of the composite catheter of the present invention.

[0025] In the figure: 1. Inner tube; 2. Middle braided layer; 3. Outer tube structure. DETAILED DESCRIPTION

[0026] The present invention will be further described below in conjunction with the accompanying drawings.

[0027] A braided reinforced polyetheretherketone composite catheter capable of continuous production, such as Figure 1 As shown, it includes an inner tube 1, an intermediate braided layer 2 and an outer tube structure 3. The materials of the inner tube 1, the intermediate braided layer 2 and the outer tube structure 3 are all made of polyetheretherketone, and the outer tube structure 3 is formed on the outside of the inner tube 1 and the intermediate braided layer 2 through a dip coating process.

[0028] The basic working principle of the present invention is: polyetheretherketone fiber filaments are woven on the outer wall of the inner tube to form an intermediate woven layer 2, and then the inner tube 1 with polyetheretherketone fiber filaments wrapped on the outer surface is used as a substrate, and an outer tube structure 3 formed of polyetheretherketone material is formed on the surface of the substrate by a dip coating process. The outer tube structure 3 formed on the outer surface of the substrate by the dip coating process can be made thinner and lighter, ensuring that the composite catheter has sufficient support performance while effectively improving the bending performance of the composite catheter. The structural characteristics of the composite catheter made of three-layer polyetheretherketone material in the present invention can realize industrial continuous production, thereby improving production and processing efficiency, and then reducing the price of composite catheters on the market by increasing output, reducing the economic burden on patients, and is conducive to continuous industrial production to improve processing efficiency, reduce the economic burden on patients, extend service life, and effectively improve the overall bending performance of the composite catheter.

[0029] The present invention provides a processing method for producing a composite conduit, comprising the following steps: S1: Preparation of inner layer tube 1, including the following steps: S101: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S102: extrusion molding: heating the polyetheretherketone particles to a molten state, and extruding them through an extruder to form a hollow inner tube 1; S103: Cooling and shaping: cooling and shaping the extruded inner tube 1 through a cooling device; S104: Surface treatment: mechanically grinding the outer wall of the inner tube 1 to increase the friction of the outer surface of the inner tube 1, thereby improving the bonding force between the outer surface of the inner tube 1 and the middle braided layer 2; S2: Preparation of the intermediate braided layer 2, comprising the following steps: S201: Raw material preparation: Polyetheretherketone fiber yarn is selected as the weaving material; S202: Weaving and forming: the inner tube 1 prepared in S1 is positioned on a three-dimensional weaving machine, and the polyetheretherketone fiber filaments are weaved on the outer wall of the inner tube 1 by the three-dimensional weaving machine to form an intermediate braided layer 2; S3: Preparation of outer tube structure 3, including the following steps: S301: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S302: Melting: heating the polyetheretherketone particles in the heating kettle to melt them into a molten adhesive state, and maintaining the polyetheretherketone in the heating kettle in a molten adhesive state by continuous heating to obtain a polyetheretherketone molten adhesive; S303: Impregnation: vertically placing the inner tube 1 wrapped with the middle braided layer 2 as the base material into the heating kettle to fully impregnate it with the polyetheretherketone melt; S304: pulling: pulling the substrate, by adjusting the balance between the viscosity of the polyetheretherketone melt and the pulling speed to ensure that the polyetheretherketone melt surface does not vibrate, thereby forming a polyetheretherketone film of uniform thickness and continuity on the surface of the substrate; S305: degassing: after the pulling is completed, the substrate with the polyetheretherketone film on the surface is placed in a heating degassing device in a rotating state for drying and heating to remove bubbles in the polyetheretherketone melt attached to the surface of the substrate; S306: Curing: The temperature in the heating and defoaming device is uniformly and slowly lowered until the polyetheretherketone melt is solidified on the surface of the substrate and forms a uniform film, and finally an outer tube structure 3 is formed outside the inner tube 1 and the middle braided layer 2.

[0030] In step S103, the cooling device is set as a cooling water tank, and the inner tube 1 extruded by the extruder is pulled into the circulating water in the cooling water tank, and the inner tube 1 is cooled by the circulating water to complete the cooling and shaping of the inner tube 1; the diameter of the polyetheretherketone fiber in step S201 is set between 50 and 200 microns; the three-dimensional braiding machine of the intermediate braided tube in step S202 is braided in one of plain weave, twill weave or satin weave. In this embodiment, the plain weave is selected, and the braiding density of the polyetheretherketone fiber in the intermediate braided tube in step S202 is set at 5-20 strands. / cm; the heating temperature of the heating kettle in step S302 is maintained between 330-400°C. Since the melting temperature of polyetheretherketone is 334°C, and the thermal weight loss can be guaranteed to be zero below 400°C, and the polyetheretherketone will undergo phase change after exceeding 400°C, which affects the coating effect of the polyetheretherketone molten adhesive. Therefore, maintaining the heating temperature of the heating kettle between 330-400°C can ensure that the polyetheretherketone in the reaction kettle is always kept in a molten adhesive state, and at the same time, it is also beneficial to precipitate and exhaust the bubbles in the polyetheretherketone molten adhesive; the viscosity range of the polyetheretherketone molten adhesive in step S304 is maintained at 350-480Pa. s, the pulling speed is controlled between 0.1-10mm / min to ensure that the polyetheretherketone melt surface does not vibrate, so as to form a polyetheretherketone film of equal thickness and continuity on the surface of the substrate. In this embodiment, the thickness of the polyetheretherketone film is controlled between 0.5-5mm; in step S305, the degassing temperature of the heating degassing device is controlled between 110-130℃, the degassing time is controlled between 1-4h, and the inside of the heating degassing device is maintained at a low vacuum state of 1KPa-80kpa to ensure that the polyetheretherketone melt coated on the outer surface of the substrate does not carry bubbles; in step S306, the cooling rate of the heating degassing device is controlled at 0.5-1℃ / min, controlling the heating and degassing device to cool down slowly and evenly is conducive to making the polyetheretherketone melt solidify evenly on the outer surface of the substrate, and preventing the polyetheretherketone melt from having crack defects when solidifying on the outer surface of the substrate; a rotating clamping device is provided in the heating and degassing device, and the rotating clamping device is used to drive the substrate horizontally placed in the heating and degassing device and coated with the polyetheretherketone melt to keep rotating at a uniform speed during heating, so as to ensure the concentricity of the polyetheretherketone melt coated on the outer surface of the substrate during the degassing process, and prevent the polyetheretherketone melt from dripping from the surface of the base material by gravity during the degassing process; and the present invention sets the inner tube 1, the middle braided layer 2 and the outer tube structure 3 as all polyetheretherketone materials, and utilizes the excellent chemical stability and creep resistance of polyetheretherketone itself, and the polyetheretherketone melt has a high melt thermal stability, and the melt of polyetheretherketone has melt fluidity, so that the composite conduit made of three layers of polyetheretherketone material can withstand repeated bending and extend The composite catheter has a long service life, and polyetheretherketone has excellent biocompatibility, which can reduce the rejection reaction between the composite catheter and the human body; in addition, the present invention prepares the inner tube 1 through the first process, and then polishes the outer surface of the inner tube 1, and then moves the inner tube 1 to the second process, and three-dimensionally braids the inner tube 1 through the second process to form an intermediate braided layer 2. At the same time, the polyetheretherketone particles are pre-melted in a heating kettle in the third process to form a polyetheretherketone melt, and then the inner tube 1 wrapped with the intermediate braided layer 2 obtained in the second process is put into the heating kettle as a substrate, and a layer of polyetheretherketone outer tube structure 3 is formed on the outer surface of the substrate through the dipping and pulling steps, and finally the polyetheretherketone melt coated on the outer surface of the substrate is solidified on the outer surface of the substrate in a bubble-free state with equal thickness through the degassing and curing steps, and finally a composite catheter made of three-layer polyetheretherketone pipe is formed, so as to realize the continuous processing and production of the polyetheretherketone composite catheter of the present invention. .

[0031] An application of a composite catheter. The composite catheter of the invention is used for preparing materials for interventional treatment instruments for cardiovascular diseases.

[0032] The above description is only a preferred embodiment of the present invention. Any equivalent changes or modifications made according to the structure, characteristics and principles described in the scope of the patent application of the present invention are included in the scope of the patent application of the present invention.

Claims

1. A braided reinforced polyetheretherketone composite catheter capable of continuous production, characterized in that: The invention comprises an inner tube (1), an intermediate braided layer (2) and an outer tube structure (3), wherein the materials of the inner tube (1), the intermediate braided layer (2) and the outer tube structure (3) are all polyetheretherketone, and the outer tube structure (3) is formed on the outside of the inner tube (1) and the intermediate braided layer (2) by a dip coating process.

2. A processing method for producing the composite conduit according to claim 1, characterized in that: The following steps are involved: S1: Preparation of the inner layer tube (1), comprising the following steps: S101: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S102: extrusion molding: heating the polyetheretherketone particles to a molten state, and extruding them through an extruder to form a hollow inner tube (1); S103: Cooling and shaping: cooling and shaping the extruded inner layer tube (1) through a cooling device; S104: Surface treatment: mechanically grinding the outer wall of the inner tube (1) to increase the friction force of the outer surface of the inner tube (1), thereby improving the bonding force between the outer surface of the inner tube (1) and the middle braided layer (2); S2: preparing the intermediate braided layer (2), comprising the following steps: S201: Raw material preparation: Polyetheretherketone fiber yarn is selected as the weaving material; S202: Weaving and forming: the inner tube (1) prepared in S1 is positioned on a three-dimensional weaving machine, and the polyetheretherketone fiber filaments are weaved onto the outer wall of the inner tube (1) by the three-dimensional weaving machine to form an intermediate braided layer (2); S3: Preparation of the outer tube structure (3), comprising the following steps: S301: Raw material preparation: Polyetheretherketone granules are selected as raw materials; S302: Melting: heating the polyetheretherketone particles in the heating kettle to melt them into a molten adhesive state, and maintaining the polyetheretherketone in the heating kettle in a molten adhesive state by continuous heating to obtain a polyetheretherketone molten adhesive; S303: Impregnation: vertically placing the inner tube (1) wrapped with the middle braided layer (2) as a base material into a heating kettle to fully impregnate it with the polyetheretherketone melt; S304: pulling: pulling the substrate, by adjusting the balance between the viscosity of the polyetheretherketone melt and the pulling speed to ensure that the polyetheretherketone melt surface does not vibrate, thereby forming a polyetheretherketone film of uniform thickness and continuity on the surface of the substrate; S305: degassing: after the pulling is completed, the substrate with the polyetheretherketone film on the surface is placed in a heating degassing device in a rotating state for drying and heating to remove bubbles in the polyetheretherketone melt attached to the surface of the substrate; S306: Curing: The temperature in the heating and degassing device is uniformly and slowly lowered until the polyetheretherketone melt is solidified on the surface of the substrate and forms a uniform film, and finally an outer tube structure (3) is formed outside the inner tube (1) and the middle braided layer (2).

3. The method for processing a composite conduit according to claim 2, characterized in that: In step S103, the cooling device is set as a cooling water tank.

4. The method for processing a composite conduit according to claim 2, characterized in that: The diameter of the polyetheretherketone fiber filament in step S201 is set between 50-200 microns.

5. The method for processing a composite conduit according to claim 2, characterized in that: In step S302, the heating temperature of the heating kettle is maintained between 330-400°C.

6. The method for processing a composite conduit according to claim 2, characterized in that: The viscosity of the polyetheretherketone melt in step S304 is maintained between 350-480 Pa·s, and the pulling speed is controlled between 0.1-10 mm / min.

7. The method for processing a composite conduit according to claim 2, characterized in that: In step S305, the defoaming temperature of the heating defoaming device is controlled between 110-130°C, the internal pressure of the heating defoaming device is controlled between 1KPa-80kPa, and the defoaming time is controlled between 1-4h.

8. The method for processing a composite conduit according to claim 2, characterized in that: In step S306, the cooling rate of the heating and defoaming device is controlled at 0.5-1°C / min.

9. The method for processing a composite conduit according to claim 2, characterized in that: A rotating clamping device is arranged in the heating and defoaming device, and the rotating clamping device is used to drive the substrate which is horizontally placed in the heating and defoaming device and coated with polyetheretherketone melt adhesive to rotate at a uniform speed during heating.

10. Use of the composite catheter according to claim 1, characterized in that: Composite catheters are used as materials for preparing interventional treatment instruments for cardiovascular diseases.

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