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WO2021120740A1 - Medical tubing and manufacturing method thereof - Google Patents

Medical tubing and manufacturing method thereof Download PDF

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Publication number
WO2021120740A1
WO2021120740A1 PCT/CN2020/116302 CN2020116302W WO2021120740A1 WO 2021120740 A1 WO2021120740 A1 WO 2021120740A1 CN 2020116302 W CN2020116302 W CN 2020116302W WO 2021120740 A1 WO2021120740 A1 WO 2021120740A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
polytetrafluoroethylene
adhesive
medical tubing
braided
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/116302
Other languages
French (fr)
Chinese (zh)
Inventor
秦明林
李兆敏
赵涛
张新华
阙亦云
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovapath Medtech Shanghai Co Ltd
Accupath Medical Jiaxing Co Ltd
Original Assignee
Innovapath Medtech Shanghai Co Ltd
Accupath Medical Jiaxing Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovapath Medtech Shanghai Co Ltd, Accupath Medical Jiaxing Co Ltd filed Critical Innovapath Medtech Shanghai Co Ltd
Publication of WO2021120740A1 publication Critical patent/WO2021120740A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B32B27/322—Layered products comprising a layer of synthetic resin comprising polyolefins comprising halogenated polyolefins, e.g. PTFE
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/12—Layered products comprising a layer of synthetic resin next to a fibrous or filamentary layer
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/0076—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised in that the layers are not bonded on the totality of their surfaces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
    • B32B37/1284—Application of adhesive
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00—Ancillary operations in connection with laminating processes
    • B32B38/08—Impregnating
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00—Ancillary operations in connection with laminating processes
    • B32B38/16—Drying; Softening; Cleaning
    • B32B38/164—Drying
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
    • B32B5/024—Woven fabric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L11/00—Hoses, i.e. flexible pipes
    • F16L11/04—Hoses, i.e. flexible pipes made of rubber or flexible plastics
    • F16L11/08—Hoses, i.e. flexible pipes made of rubber or flexible plastics with reinforcements embedded in the wall
    • F16L11/085—Hoses, i.e. flexible pipes made of rubber or flexible plastics with reinforcements embedded in the wall comprising one or more braided layers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L9/00—Rigid pipes
    • F16L9/14—Compound tubes, i.e. made of materials not wholly covered by any one of the preceding groups
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
    • B32B2037/1253—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives curable adhesive
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B38/00—Ancillary operations in connection with laminating processes
    • B32B2038/0052—Other operations not otherwise provided for
    • B32B2038/0076—Curing, vulcanising, cross-linking
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/558—Impact strength, toughness
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2327/00—Polyvinylhalogenides
    • B32B2327/12—Polyvinylhalogenides containing fluorine
    • B32B2327/18—PTFE, i.e. polytetrafluoroethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical tube and a preparation method thereof.
  • Medical composite pipes are usually composed of multiple layers. Due to the inconsistent materials of each layer and the different bonding properties, the delamination is abnormal. In pipe construction, delamination is a serious failure mode, which has a great impact on product performance. However, the delamination phenomenon is difficult to detect before the final test of the product, and the delamination problem is found during the test after the pipe assembly is completed, which will cause considerable cost loss.
  • the purpose of the present invention is to provide a medical tube and a preparation method thereof, which can enhance the adhesion between layers and prevent abnormal delamination between layers.
  • the present invention provides a medical tube, comprising a polytetrafluoroethylene inner layer, a braided layer, and an outer layer arranged in order from the inside to the outside, between the inner layer of the polytetrafluoroethylene and the braided layer And/or an adhesive layer is provided between the braided layer and the outer layer.
  • the material of the adhesive layer is at least one of polyamide, polyimide, polyether block amide, and thermoplastic polyurethane.
  • the material of the outer layer is polyether block amide, nylon 6, nylon 12, polyimide or thermoplastic polyurethane.
  • the inner polytetrafluoroethylene layer has an etched surface.
  • the thickness of the adhesive layer is 0.0001 mm to 0.0025 mm.
  • the present invention also provides a method for preparing medical tubing, including the following steps: S1: fixing the inner layer of polytetrafluoroethylene on the core rod, and immersing the core rod in the adhesive In the dipping tank, the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer; S2: Put the mandrel into the oven, and apply the adhesive to the outer surface of the polytetrafluoroethylene inner layer.
  • the adhesive on the surface is heated and cured to form a bonding layer on the outer surface of the inner layer of PTFE;
  • S3 braided wire is knitted on the bonding layer to form a braided layer;
  • S4 on the The outer layer of the braid is covered with an outer layer and thermally welded and bonded.
  • the solid content of the binder is 10-20%.
  • the polytetrafluoroethylene inner layer is etched.
  • the temperature range for heating and curing the adhesive on the outer surface of the polytetrafluoroethylene inner layer is 100-260°C.
  • the method further includes step S5: putting a sleeve on the outer layer and performing thermal welding to form a medical tube.
  • the present invention has the following beneficial effects: the medical tubing provided by the present invention and the preparation method thereof increase adhesion between the inner polytetrafluoroethylene layer and the braided layer and/or between the braided layer and the outer layer of the medical tubing.
  • the bonding layer forms a surface that can be melted and bonded to enhance the adhesion between the layers, thereby effectively preventing the abnormal delamination of the medical tubing, especially the medical tubing, and reducing the use of the medical terminal
  • the accident rate is to improve the torsion control performance of medical tubing while maintaining the flexibility of the original tubing.
  • Figure 1 is a schematic diagram of the structure of a medical tube in an embodiment of the invention.
  • the present invention takes medical tubing as an example.
  • the bonding layer forms a meltable Adhesive surface to enhance the adhesion between the layers, thereby effectively preventing the abnormal delamination between the layers of the pipe.
  • the adhesive layer can be arranged between the inner layer and the braided layer of the medical tube, between the braided layer and the outer layer, between the outer layer and the sleeve, etc.
  • the present invention can also be used The bonding layer is applied to any round bar.
  • the adhesive layer needs to have biocompatibility.
  • a thermoplastic material approved by USP Class VI U.S. Pharmacopoeia standard VI testing
  • the bonding layer also needs to have hot melt properties, be easy to melt, and be combined with the sleeve heat shrinking process to form a strong thermal welding bond.
  • the bonding layer needs to have good bonding strength.
  • the bonding layer can increase the linear bonding strength by at least 2.5 times compared with a non-laminated sheath structure.
  • the material of the bonding layer can be selected according to the material of the pipe layer to be bonded, and the material of the bonding layer can be polyamide (PA), polyimide (PI), thermoplastic polyurethane (TPU) or polyether block Amide (PEBA) and so on.
  • the bonding layer may be a thin layer, and the thickness of the bonding layer may be as low as 0.0025 mm to reduce the thickness of the pipe.
  • the medical tubing provided in this embodiment includes a polytetrafluoroethylene inner layer 2, a bonding layer 3, a braided layer 4, an outer layer 5, and a sleeve 6 arranged in order from the inside to the outside.
  • the inner polytetrafluoroethylene layer 2, the braided layer 4 and the adhesive layer 3 are connected together by mechanical coupling.
  • the bonding layer 3 is melted and bonded with the inner layer 2 and the outer layer 5 of polytetrafluoroethylene.
  • the inner polytetrafluoroethylene layer also has an etched surface.
  • the preparation method of medical tubing includes the following steps:
  • Step S1 firstly etch the inner layer of PTFE, fix the etched inner layer of PTFE on the mandrel, and immerse the mandrel in the dipping tank with adhesive to make the adhesive
  • the binding agent is coated on the outer surface of the polytetrafluoroethylene inner layer.
  • the binder in the dipping tank may be at least one of polyamide, polyimide, polyether block amide (PEBA), thermoplastic polyurethane (TPU), and the like.
  • the solid content of the binder can be 10-20%.
  • the solid content in the present invention refers to the mass percentage of the remaining part of the binder after drying.
  • the role of the adhesive is to better bond the layers of the composite pipe together.
  • Step S2 Put the mandrel vertically into an oven, heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene, and set the curing temperature according to the characteristics of the adhesive.
  • a bonding layer is formed on the outer surface of the tetrafluoroethylene inner layer.
  • the mandrel is placed vertically in an oven for vertical lifting, and a bonding layer coating with uniform thickness can be formed.
  • Step S3 Using a braiding machine, weave the braided wire on the bonding layer to form a braided layer.
  • Step S4 Put an outer layer on the braided layer, and perform thermal welding and bonding with a welding machine.
  • the material of the outer layer matches the material of the adhesive layer.
  • the compatibility of the two should be good, otherwise it will be layered and cannot be bonded together. Therefore, the medical polymer material used in the outer layer is preferably a thermoplastic, such as: poly Ether block amide (PEBA), nylon 6 (PA6), nylon 12 (PA12), polyimide (PI) and thermoplastic polyurethane (TPU), etc.
  • PEBA poly Ether block amide
  • PA6 nylon 6
  • PA12 nylon 12
  • PI polyimide
  • TPU thermoplastic polyurethane
  • Step S5 Put a sleeve on the outer layer and perform thermal welding with a welding machine to form the medical tube.
  • the core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating.
  • the etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer.
  • the binder in the dipping tank is polyether block amide (PEBA) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heating and curing ranges from 100 to 240°C. A bonding layer is formed on the outer surface of the inner layer.
  • PEBA polyether block amide
  • a braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding.
  • the outer layer is made of polyether block amide (PEBA).
  • PEBA polyether block amide
  • a sleeve is sleeved on the outer layer and thermally welded with a welding machine to make a medical tube.
  • the core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating.
  • the etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer.
  • the binder in the dipping tank is nylon 6 (PA6) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heat curing is in the range of 100 to 260°C. A bonding layer is formed on the outer surface of the inner layer.
  • a braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding.
  • the outer layer is made of polyether block amide (Pebax).
  • a sleeve is placed on the outer layer and thermally welded with a welding machine to form a medical tube.
  • the core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating.
  • the etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer.
  • the binder in the dipping tank is nylon 12 (PA12) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heat curing is in the range of 100 to 260°C. A bonding layer is formed on the outer surface of the inner layer.
  • a braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding.
  • the outer layer is made of polyether block amide (Pebax).
  • a sleeve is sleeved on the outer layer and thermally welded with a welding machine to make a medical tube.
  • the difference between this embodiment and the medical tube of embodiment 1 lies in the choice of adhesive.
  • the adhesive in this example is thermoplastic polyurethane (TPU).
  • TPU thermoplastic polyurethane
  • the temperature range for heating and curing the adhesive on the outer surface of the polytetrafluoroethylene inner layer is 100-240°C.
  • the medical tubing provided by the examples of the present invention and the preparation method thereof have at least the following advantages:
  • the present invention adds a bonding layer between the layers of the medical tubing, effectively preventing the delamination phenomenon between the layers of the tubing, and reducing the accident rate of the medical terminal.
  • the preparation method provided by the present invention has a simple process, can be produced intermittently, and can also be produced on a continuous scale.
  • the preparation method provided by the present invention is suitable for any round bar composite multilayer tube, and has a wide range of applications.
  • the bonding layer in the present invention effectively fixes the braided wire during the fusion bonding process, and improves the torsion control performance of the medical tube while maintaining the flexibility of the original tube.

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  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Textile Engineering (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Disclosed are a medical tubing and a manufacturing method thereof. The medical tubing comprises an inner polytetrafluoroethylene layer, a woven layer and an outer layer sequentially arranged in an outward direction. An adhesive layer is provided between the inner polytetrafluoroethylene layer and the woven layer and/or between the woven layer and the outer layer. In the medical tubing and the manufacturing method thereof provided in the present invention, provision of an adhesive layer between layers of a medical tubing effectively prevents separation of the layers, thereby reducing an accident rate relating to usage of the medical tubing, and enhancing twisting control performance of the medical tubing while maintaining flexibility of thereof.

Description

一种医用管材及其制备方法Medical tube and preparation method thereof 技术领域Technical field

本发明涉及医疗器械技术领域，尤其涉及一种医用管材及其制备方法。The invention relates to the technical field of medical devices, in particular to a medical tube and a preparation method thereof.

背景技术Background technique

医用复合管材通常由多层组成，由于各层材质不一致，粘结性能不同而导致分层异常。在管材构造中，分层是一种严重的失效模式，对产品性能有很大影响。但是，分层现象在产品最终测试之前很难检测到，在管材组装完成之后测试时发现分层问题，会导致相当大的成本损失。Medical composite pipes are usually composed of multiple layers. Due to the inconsistent materials of each layer and the different bonding properties, the delamination is abnormal. In pipe construction, delamination is a serious failure mode, which has a great impact on product performance. However, the delamination phenomenon is difficult to detect before the final test of the product, and the delamination problem is found during the test after the pipe assembly is completed, which will cause considerable cost loss.

发明内容Summary of the invention

本发明的目的在于提供一种医用管材及其制备方法，能够增强层与层之间的粘附力，防止各层间的分层异常。The purpose of the present invention is to provide a medical tube and a preparation method thereof, which can enhance the adhesion between layers and prevent abnormal delamination between layers.

为解决上述技术问题，本发明提供了一种医用管材，包括由内向外依次设置的聚四氟乙烯内层、编织层和外层，所述聚四氟乙烯内层和所述编织层之间和/或所述编织层和所述外层之间设置有粘结层。In order to solve the above technical problems, the present invention provides a medical tube, comprising a polytetrafluoroethylene inner layer, a braided layer, and an outer layer arranged in order from the inside to the outside, between the inner layer of the polytetrafluoroethylene and the braided layer And/or an adhesive layer is provided between the braided layer and the outer layer.

优选地，所述粘结层的材料为聚酰胺、聚酰亚胺、聚醚嵌段酰胺、热塑性聚氨酯中的至少一种。Preferably, the material of the adhesive layer is at least one of polyamide, polyimide, polyether block amide, and thermoplastic polyurethane.

优选地，所述外层的材料为聚醚嵌段酰胺、尼龙6、尼龙12、聚酰亚胺或热塑性聚氨酯。Preferably, the material of the outer layer is polyether block amide, nylon 6, nylon 12, polyimide or thermoplastic polyurethane.

优选地，所述聚四氟乙烯内层具有经刻蚀的表面。Preferably, the inner polytetrafluoroethylene layer has an etched surface.

优选地，所述粘结层的厚度为0.0001毫米-0.0025毫米。Preferably, the thickness of the adhesive layer is 0.0001 mm to 0.0025 mm.

为解决上述技术问题，本发明还提供了一种医用管材的制备方法，包括如下步骤：S1：将聚四氟乙烯内层固定在芯棒上，并将所述芯棒浸入具有粘结剂的浸渍槽中，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上；S2：将所述芯棒放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，在所述聚四氟乙烯内层的外表面上形成粘结层；S3：将编织丝编织在所述粘结层上形成编织层；S4：在所述编织层的外部套上外层，并进行热 焊接粘合。In order to solve the above technical problems, the present invention also provides a method for preparing medical tubing, including the following steps: S1: fixing the inner layer of polytetrafluoroethylene on the core rod, and immersing the core rod in the adhesive In the dipping tank, the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer; S2: Put the mandrel into the oven, and apply the adhesive to the outer surface of the polytetrafluoroethylene inner layer. The adhesive on the surface is heated and cured to form a bonding layer on the outer surface of the inner layer of PTFE; S3: braided wire is knitted on the bonding layer to form a braided layer; S4: on the The outer layer of the braid is covered with an outer layer and thermally welded and bonded.

优选地，所述粘结剂的固含量为10-20％。Preferably, the solid content of the binder is 10-20%.

优选地，所述步骤S1中，将所述将聚四氟乙烯内层固定在芯棒上之前，对所述聚四氟乙烯内层进行刻蚀。Preferably, in the step S1, before fixing the polytetrafluoroethylene inner layer on the mandrel, the polytetrafluoroethylene inner layer is etched.

优选地，所述步骤S2中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100～260℃。Preferably, in the step S2, the temperature range for heating and curing the adhesive on the outer surface of the polytetrafluoroethylene inner layer is 100-260°C.

优选地，还包括步骤S5：在所述外层上套上套管，并进行热焊接，制成医用管材。Preferably, the method further includes step S5: putting a sleeve on the outer layer and performing thermal welding to form a medical tube.

本发明对比现有技术有如下的有益效果：本发明提供的医用管材及其制备方法通过在医用管材的聚四氟乙烯内层和编织层之间和/或编织层和外层之间增加粘结层，粘结层形成可熔融粘合的表面，以增强层与层之间的粘附力，从而有效的防止了医用管材特别是医用管材各层间的分层异常，降低了医疗终端使用事故率，还在保持原有管材的柔韧性能的同时，提高医用管材的扭控性能。Compared with the prior art, the present invention has the following beneficial effects: the medical tubing provided by the present invention and the preparation method thereof increase adhesion between the inner polytetrafluoroethylene layer and the braided layer and/or between the braided layer and the outer layer of the medical tubing. The bonding layer forms a surface that can be melted and bonded to enhance the adhesion between the layers, thereby effectively preventing the abnormal delamination of the medical tubing, especially the medical tubing, and reducing the use of the medical terminal The accident rate is to improve the torsion control performance of medical tubing while maintaining the flexibility of the original tubing.

附图说明Description of the drawings

图1为本发明实施例中医用管材的结构示意图。Figure 1 is a schematic diagram of the structure of a medical tube in an embodiment of the invention.

具体实施方式Detailed ways

下面结合附图和实施例对本发明作进一步的描述。The present invention will be further described below in conjunction with the drawings and embodiments.

在以下描述中，为了提供本发明的透彻理解，阐述了很多具体的细节。然而，本发明可以在没有这些具体的细节的情况下实践，这对本领域普通该技术人员来说将是容易理解的。因此，具体的细节阐述仅仅是示例性的，具体的细节可以由奔放的精神和范围而变化并且仍被认为是在本发明的精神和范围内。In the following description, in order to provide a thorough understanding of the present invention, many specific details are set forth. However, the present invention can be practiced without these specific details, which will be easily understood by those of ordinary skill in the art. Therefore, the specific details are only exemplary, and the specific details may be changed by the unrestrained spirit and scope and are still considered to be within the spirit and scope of the present invention.

为了实现上述目的，本发明以医用管材为例，通过在医用管材的聚四氟乙烯内层和编织层之间和/或编织层和外层之间增加粘结层，粘结层形成可熔融粘合的表面，以增强层与层之间的粘附力，从而有效的防止了管材各管层间的分层异常。在本发明中，所述粘结层可设置于医用管材的内层与编织层 之间，编织层与外层之间，外层与套管之间等，事实上，还可以将本发明中的粘结层应用到任何圆形棒材上。In order to achieve the above objectives, the present invention takes medical tubing as an example. By adding a bonding layer between the inner polytetrafluoroethylene layer and the braided layer and/or between the braided layer and the outer layer of the medical tubing, the bonding layer forms a meltable Adhesive surface to enhance the adhesion between the layers, thereby effectively preventing the abnormal delamination between the layers of the pipe. In the present invention, the adhesive layer can be arranged between the inner layer and the braided layer of the medical tube, between the braided layer and the outer layer, between the outer layer and the sleeve, etc. In fact, the present invention can also be used The bonding layer is applied to any round bar.

所述粘结层需要具备生物相容性，例如USP Class VI(美国药典标准VI级检测)认可的热塑性材料可用于粘结层涂层。所述粘结层还需要具备热融性，易于熔化并与套管热缩工艺相结合，以形成强烈的热焊接粘合。另外，所述粘结层需要具备良好的粘合强度，例如与非层压护套结构相比，所述粘结层可将线性粘合强度提高至少2.5倍。所述粘结层的材料可根据需粘结的管层材质进行选择，粘结层的材料可以为聚酰胺(PA)、聚酰亚胺(PI)、热塑性聚氨酯(TPU)或聚醚嵌段酰胺(PEBA)等。所述粘结层可以为薄层，粘结层的厚度可低至0.0025mm，以降低管材的厚度。The adhesive layer needs to have biocompatibility. For example, a thermoplastic material approved by USP Class VI (U.S. Pharmacopoeia standard VI testing) can be used for the adhesive layer coating. The bonding layer also needs to have hot melt properties, be easy to melt, and be combined with the sleeve heat shrinking process to form a strong thermal welding bond. In addition, the bonding layer needs to have good bonding strength. For example, the bonding layer can increase the linear bonding strength by at least 2.5 times compared with a non-laminated sheath structure. The material of the bonding layer can be selected according to the material of the pipe layer to be bonded, and the material of the bonding layer can be polyamide (PA), polyimide (PI), thermoplastic polyurethane (TPU) or polyether block Amide (PEBA) and so on. The bonding layer may be a thin layer, and the thickness of the bonding layer may be as low as 0.0025 mm to reduce the thickness of the pipe.

如图1所示，本实施例提供的医用管材包括由内向外依次设置的聚四氟乙烯内层2、粘结层3、编织层4、外层5和套管6，所述医用管材套设于芯棒1上。聚四氟乙烯内层2、编织层4与粘结层3通过机械耦合连接在一起。在一定的温度下，粘结层3熔化后与聚四氟乙烯内层2、外层5相互粘结。在本实施例中，所述聚四氟乙烯内层还具有经刻蚀的表面。As shown in Figure 1, the medical tubing provided in this embodiment includes a polytetrafluoroethylene inner layer 2, a bonding layer 3, a braided layer 4, an outer layer 5, and a sleeve 6 arranged in order from the inside to the outside. Set on the mandrel 1. The inner polytetrafluoroethylene layer 2, the braided layer 4 and the adhesive layer 3 are connected together by mechanical coupling. At a certain temperature, the bonding layer 3 is melted and bonded with the inner layer 2 and the outer layer 5 of polytetrafluoroethylene. In this embodiment, the inner polytetrafluoroethylene layer also has an etched surface.

本实施例中，医用管材的制备方法包括以下步骤：In this embodiment, the preparation method of medical tubing includes the following steps:

步骤S1：首先对所述聚四氟乙烯内层进行刻蚀，将刻蚀的聚四氟乙烯内层固定在芯棒上，并将芯棒浸入具有粘结剂的浸渍槽，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中，浸渍槽内的粘结剂可以是聚酰胺、聚酰亚胺、聚醚嵌段酰胺(PEBA)和热塑性聚氨酯(TPU)等中的至少一种。粘结剂的固含量可以为10-20％，本发明中的固含量是指粘结剂烘干后剩余部分占总量的质量百分数。粘结剂的作用是为了使复合管材的层与层之间更好的粘结在一起。Step S1: firstly etch the inner layer of PTFE, fix the etched inner layer of PTFE on the mandrel, and immerse the mandrel in the dipping tank with adhesive to make the adhesive The binding agent is coated on the outer surface of the polytetrafluoroethylene inner layer. Wherein, the binder in the dipping tank may be at least one of polyamide, polyimide, polyether block amide (PEBA), thermoplastic polyurethane (TPU), and the like. The solid content of the binder can be 10-20%. The solid content in the present invention refers to the mass percentage of the remaining part of the binder after drying. The role of the adhesive is to better bond the layers of the composite pipe together.

步骤S2：将所述芯棒垂直放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，固化温度根据粘结剂特性进行设置，在所述聚四氟乙烯内层的外表面上形成粘结层。本步骤中将所述芯棒垂直放入烘炉中进行垂直提拉，可以形成厚度均匀的粘结层涂层。Step S2: Put the mandrel vertically into an oven, heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene, and set the curing temperature according to the characteristics of the adhesive. A bonding layer is formed on the outer surface of the tetrafluoroethylene inner layer. In this step, the mandrel is placed vertically in an oven for vertical lifting, and a bonding layer coating with uniform thickness can be formed.

步骤S3：使用编织机，将编织丝编织在所述粘结层上，形成编织层。Step S3: Using a braiding machine, weave the braided wire on the bonding layer to form a braided layer.

步骤S4：在所述编织层上套上外层，用焊接机进行热焊接粘合。外层的 材料和粘结层的材料相匹配，两者的相容性要好，不然会分层，不能粘结在一起，因此，外层所用的医用高分子材料优选为热塑性塑料，例如：聚醚嵌段酰胺(PEBA)、尼龙6(PA6)、尼龙12(PA12)、聚酰亚胺(PI)以及热塑性聚氨酯(TPU)等。Step S4: Put an outer layer on the braided layer, and perform thermal welding and bonding with a welding machine. The material of the outer layer matches the material of the adhesive layer. The compatibility of the two should be good, otherwise it will be layered and cannot be bonded together. Therefore, the medical polymer material used in the outer layer is preferably a thermoplastic, such as: poly Ether block amide (PEBA), nylon 6 (PA6), nylon 12 (PA12), polyimide (PI) and thermoplastic polyurethane (TPU), etc.

步骤S5：在所述外层上套上套管，用焊接机进行热焊接，制成所述医用管材。Step S5: Put a sleeve on the outer layer and perform thermal welding with a welding machine to form the medical tube.

下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明公开的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。The present invention will be further explained below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the disclosure of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

实施例1Example 1

芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上，并将芯棒1浸入具有粘结剂的浸渍槽，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中，浸渍槽内的粘结剂是聚醚嵌段酰胺(PEBA)，固含量为20％。将所述芯棒1垂直放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，加热固化温度范围100～240℃，在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上，形成编织层；在所述编织层的外部套上外层，并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(PEBA)。在所述外层上套上套管，并用焊接机进行热焊接，制成医用管材。The core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating. The etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer. On the surface. Among them, the binder in the dipping tank is polyether block amide (PEBA) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heating and curing ranges from 100 to 240°C. A bonding layer is formed on the outer surface of the inner layer. A braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding. The outer layer is made of polyether block amide (PEBA). A sleeve is sleeved on the outer layer and thermally welded with a welding machine to make a medical tube.

实施例2Example 2

芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上，并将芯棒1浸入具有粘结剂的浸渍槽，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中，浸渍槽内的粘结剂是尼龙6(PA6)，固含量为20％。将所述芯棒1垂直放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，加热固化温度范围100～260℃，在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上，形成编织层；在所述编织层的外部套上外层，并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(Pebax)。在所述外层上套上套管，并用焊接机进 行热焊接，制成医用管材。The core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating. The etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer. On the surface. Among them, the binder in the dipping tank is nylon 6 (PA6) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heat curing is in the range of 100 to 260°C. A bonding layer is formed on the outer surface of the inner layer. A braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding. The outer layer is made of polyether block amide (Pebax). A sleeve is placed on the outer layer and thermally welded with a welding machine to form a medical tube.

实施例3Example 3

芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上，并将芯棒1浸入具有粘结剂的浸渍槽，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中，浸渍槽内的粘结剂是尼龙12(PA12)，固含量为20％。将所述芯棒1垂直放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，加热固化温度范围100～260℃，在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上，形成编织层；在所述编织层的外部套上外层，并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(Pebax)。在所述外层上套上套管，并用焊接机进行热焊接，制成医用管材。The core rod 1 is a stainless steel rod with a polytetrafluoroethylene coating. The etched polytetrafluoroethylene inner layer is sheathed on the core rod 1, and the core rod 1 is immersed in a dipping tank with an adhesive, so that the adhesive is coated on the outer surface of the polytetrafluoroethylene inner layer. On the surface. Among them, the binder in the dipping tank is nylon 12 (PA12) with a solid content of 20%. Put the mandrel 1 into an oven vertically to heat and cure the adhesive on the outer surface of the inner layer of polytetrafluoroethylene. The temperature of heat curing is in the range of 100 to 260°C. A bonding layer is formed on the outer surface of the inner layer. A braiding machine is used to knit the braided wire on the bonding layer to form a braided layer; an outer layer is sheathed on the outside of the braided layer, and a welding machine is used for thermal welding and bonding. The outer layer is made of polyether block amide (Pebax). A sleeve is sleeved on the outer layer and thermally welded with a welding machine to make a medical tube.

实施例4Example 4

本实施例与实施例1的医用管材，不同点在于粘结剂的选择，本实例中的粘结剂为热塑性聚氨酯(TPU)。对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100～240℃。The difference between this embodiment and the medical tube of embodiment 1 lies in the choice of adhesive. The adhesive in this example is thermoplastic polyurethane (TPU). The temperature range for heating and curing the adhesive on the outer surface of the polytetrafluoroethylene inner layer is 100-240°C.

综上，本发明例提供的医用管材及其制备方法至少具有以下优点：In summary, the medical tubing provided by the examples of the present invention and the preparation method thereof have at least the following advantages:

1)相比现有医用管材，本发明在医用管材的层与层之间增加粘结层，有效防止了各管层间的分层现象，降低了医疗终端使用事故率。1) Compared with the existing medical tubing, the present invention adds a bonding layer between the layers of the medical tubing, effectively preventing the delamination phenomenon between the layers of the tubing, and reducing the accident rate of the medical terminal.

2)本发明提供的制备方法工艺简单，可间断性生产，也可以进行连续性的规模化生产。2) The preparation method provided by the present invention has a simple process, can be produced intermittently, and can also be produced on a continuous scale.

3)本发明提供的制备方法适用于任何圆形棒材复合多层管，应用范围较广。3) The preparation method provided by the present invention is suitable for any round bar composite multilayer tube, and has a wide range of applications.

4)本发明中的粘结层，在熔融粘结过程，有效的固定了编织丝，在保持原有管材的柔韧性能的同时，提高了医用管材的扭控性能。4) The bonding layer in the present invention effectively fixes the braided wire during the fusion bonding process, and improves the torsion control performance of the medical tube while maintaining the flexibility of the original tube.

虽然本发明已以较佳实施例揭示如上，然其并非用以限定本发明，任何本领域技术人员，在不脱离本发明的精神和范围内，当可作些许的修改和完善，因此本发明的保护范围当以权利要求书所界定的为准。Although the present invention has been disclosed as above in preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the present invention The scope of protection shall be as defined in the claims.

Claims (10)

一种医用管材，其特征在于，包括由内向外依次设置的聚四氟乙烯内层、编织层和外层，所述聚四氟乙烯内层和所述编织层之间和/或所述编织层和所述外层之间设置有粘结层。A medical tube, which is characterized in that it comprises a polytetrafluoroethylene inner layer, a braided layer, and an outer layer sequentially arranged from the inside to the outside, and between the inner layer of polytetrafluoroethylene and the braided layer and/or the braided layer An adhesive layer is arranged between the layer and the outer layer. 如权利要求1所述的医用管材，其特征在于，所述粘结层的材料为聚酰胺、聚酰亚胺、聚醚嵌段酰胺、热塑性聚氨酯中的至少一种。The medical tube according to claim 1, wherein the material of the adhesive layer is at least one of polyamide, polyimide, polyether block amide, and thermoplastic polyurethane. 如权利要求1所述的医用管材，其特征在于，所述外层的材料为聚醚嵌段酰胺、尼龙6、尼龙12、聚酰亚胺或热塑性聚氨酯。The medical tube according to claim 1, wherein the material of the outer layer is polyether block amide, nylon 6, nylon 12, polyimide or thermoplastic polyurethane. 如权利要求1所述的医用管材，其特征在于，所述聚四氟乙烯内层具有经刻蚀的表面。The medical tube according to claim 1, wherein the inner layer of polytetrafluoroethylene has an etched surface. 如权利要求1所述的医用管材，其特征在于，所述粘结层的厚度为0.0001毫米-0.0025毫米。The medical tube according to claim 1, wherein the thickness of the adhesive layer is 0.0001 mm to 0.0025 mm. 一种医用管材的制备方法，其特征在于，包括如下步骤：A method for preparing medical tubing is characterized in that it comprises the following steps: S1：将聚四氟乙烯内层固定在芯棒上，并将所述芯棒浸入具有粘结剂的浸渍槽中，使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上；S1: Fix the inner polytetrafluoroethylene layer on the mandrel, and immerse the mandrel in a dip tank with an adhesive so that the adhesive is coated on the outer surface of the inner polytetrafluoroethylene layer On the surface S2：将所述芯棒放入烘炉中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化，在所述聚四氟乙烯内层的外表面上形成粘结层；S2: Put the mandrel into an oven, heat and cure the adhesive on the outer surface of the polytetrafluoroethylene inner layer to form a bond on the outer surface of the polytetrafluoroethylene inner layer Floor; S3：将编织丝编织在所述粘结层上形成编织层；S3: Weaving braided wires on the bonding layer to form a braided layer; S4：在所述编织层的外部套上外层，并进行热焊接粘合。S4: Put an outer layer on the outside of the braided layer, and perform thermal welding and bonding. 如权利要求6所述的医用管材的制备方法，其特征在于，所述粘结剂的固含量为10-20％。7. The method for preparing medical tubing according to claim 6, wherein the solid content of the binder is 10-20%. 如权利要求6所述的医用管材的制备方法，其特征在于，所述步骤S1中，将所述将聚四氟乙烯内层固定在芯棒上之前，对所述聚四氟乙烯内层进行刻蚀。The method for preparing medical tubing according to claim 6, characterized in that, in the step S1, before fixing the polytetrafluoroethylene inner layer on the mandrel, the polytetrafluoroethylene inner layer is processed Etching. 如权利要求6所述的医用管材的制备方法，其特征在于，所述步骤S2中，对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100～260℃。The method for preparing medical tubing according to claim 6, characterized in that, in the step S2, the temperature range for heating and curing the adhesive on the outer surface of the polytetrafluoroethylene inner layer is 100-260 ℃. 如权利要求6所述的医用管材的制备方法，其特征在于，还包括步 骤S5：在所述外层上套上套管，并进行热焊接，制成医用管材。The method for preparing medical tubing according to claim 6, further comprising step S5: sheathing a sleeve on the outer layer and performing thermal welding to form a medical tubing.
PCT/CN2020/116302 2019-12-18 2020-09-18 Medical tubing and manufacturing method thereof Ceased WO2021120740A1 (en)

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