PEEK medical composite catheter containing developing layer and preparation method of PEEK medical composite catheter

Abstract

The invention discloses a PEEK medical composite catheter containing a developing layer and a preparation method of the PEEK medical composite catheter. The PEEK medical composite catheter comprises an inner layer, a middle reinforcing layer and an outer layer which are sequentially arranged from inside to outside. The inner layer, the middle reinforcing layer and the outer layer are made of PEEK materials, the middle reinforcing layer is coated with a developing solution in a dip-coating mode, the developing solution is cured to form a developing layer, the developing solution is cured to form a developing layer, the catheter has a good developing effect, the developing layer is tightly connected with the middle reinforcing layer, the structure is more stable, and the service life of the catheter is prolonged. Compared with a traditional method that a developing ring is arranged on the catheter in a sleeving mode for developing, the situation that the developing ring is disengaged is avoided, and the whole developing ring has higher safety.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a PEEK medical composite catheter containing a developing layer and a preparation method thereof. Background Art

[0002] In the field of human interventional treatment, medical catheters are commonly used medical tools. In cerebrovascular interventional surgery, catheter products are mainly responsible for the construction of surgical access, the delivery of implantable devices, the injection of diagnostic reagents, and the direct aspiration of blood clots. Their frequency of use is very high.

[0003] At present, the external forging of commonly used medical catheters is provided with a developing ring for marking. The developing ring is placed at the farthest end of the catheter, that is, at the tip of the catheter. When implanted into the human body, the developing ring will directly contact the human tissue, which may cause risks such as damaging tissue or precipitating heavy metal ions, which will harm human health and there is a risk of falling. Summary of the invention

[0004] In order to solve the technical problems existing in the background technology, the present invention proposes a PEEK medical composite catheter containing a developing layer and a preparation method thereof.

[0005] The technical solution adopted by the present invention to solve the technical problem is as follows: A PEEK medical composite catheter with a developing layer comprises an inner layer, a middle reinforcing layer, and an outer layer arranged in sequence from an inner layer to an outer layer; The inner layer, the middle reinforcement layer, and the outer layer are made of PEEK material, and the middle reinforcement layer is dipped with a developing solution, which is solidified to form a developing layer.

[0006] Preferably, the developing solution is a TPU solution containing tungsten. Through the above improvements, thermoplastic polyurethane elastomer (TPU) is a type of elastomer that can be plasticized by heating and dissolved by solvents. It has excellent comprehensive properties such as high strength, high toughness, wear resistance, and oil resistance, and has good processing performance. It is widely used in defense, medical, food and other industries. Tungsten is a common material for developing rings. Tungsten powder and TPU material are dissolved together in an organic solvent (such as ethyl acetate) and dip-coated on the middle reinforcing layer. As the solution solidifies, a developing layer with excellent elasticity and developing properties will be formed on the middle reinforcing layer. Compared with traditional developing rings, it has better elasticity and will not cause damage to human blood vessels.

[0007] Preferably, the surface of the developing layer is dip-coated with a PEEK solution, and the PEEK solution is cured to form an outer layer, or the outer layer is composed of a PEEK heat shrink tube. Through the above improvements, the PEEK material can be dip-coated on the surface of the developing layer, and the outer layer is formed after heating and curing, which can protect the entire intermediate reinforcing layer and form a tight connection, or the PEEK heat shrink tube is used to form the outer layer of the catheter, wherein the PEEK heat shrink tube has excellent biocompatibility and excellent high and low temperature resistance. It can maintain flexibility at low temperatures and withstand short-term high temperatures of up to 300°C, allowing long-term use at 260°C. This material has good electrical insulation and mechanical properties, and a shrinkage rate of 1:1.4, ensuring its stability and reliability in various environments. The PEEK heat shrink tube can be heated to shrink and wrap around the intermediate reinforcing layer, thereby enhancing the protective effect and forming a tight connection with the intermediate reinforcing layer.

[0008] Preferably, the intermediate reinforcement layer is formed by three-dimensional weaving of PEEK wires. Through the above improvements, the three-dimensional weaving of PEEK fiber filaments is utilized to provide additional strength and flexibility to the entire catheter.

[0009] Preferably, a plurality of embedding holes are formed between the PEEK wires, and the developing layer is partially embedded in the embedding holes. Through the above improvements, the developing layer can penetrate into the embedding holes, thereby further improving the reliability of the connection with the middle reinforcing layer.

[0010] The present invention also provides a method for preparing a PEEK medical composite catheter containing a developing layer, comprising the following steps: S1 Inner layer molding: PEEK particles are heated to the melting point and extruded through an extruder to form a PEEK tube. The extruded PEEK tube is placed in a cooling water tank for cooling and shaping to form the inner layer of the catheter; S2 Middle reinforcement layer forming: The PEEK wire is woven into the middle reinforcement layer through a three-dimensional weaving device, and the woven middle reinforcement layer is sleeved onto the outside of the inner layer; S3 developing layer forming: immersing the middle reinforcing layer into the developing solution, so that the developing solution is evenly coated on the middle reinforcing layer; S4: After the dip coating is completed, the intermediate reinforcing layer is placed in a baking device for drying and curing, so that the developing solution is dried and cured on the intermediate reinforcing layer to form a developing layer; S5 outer layer molding: a PEEK heat shrink tube is sleeved on the outer periphery of the developing layer, or a PEEK solution is dipped on the outer periphery of the developing layer, and then the PEEK heat shrink tube is shrunk or the PEEK solution is solidified by a baking device to form the outer layer of the catheter.

[0011] Furthermore, in step S2, the surface oil stains of the middle reinforcement layer are cleaned; In step S3, the intermediate reinforcing layer that has been dip-coated is taken out, and the developing solution on the intermediate reinforcing layer is allowed to drip naturally. Through the above improvements, the prepared developing solution is evenly dip-coated on the specified area of ​​the intermediate reinforcing layer, and then drained and dried to solidify, so that the developing solution solidifies on the intermediate reinforcing layer to form a developing layer. Compared with the traditional developing ring, it not only has good elasticity and will not scratch the blood vessels, but also fits tightly with the intermediate reinforcing layer and will not detach like the developing ring. In addition, unlike the conventional developing ring that needs to be set at the farthest end of the catheter, the developing solution can be dip-coated at any position of the intermediate reinforcing layer, and the dipping area is not limited, which greatly improves the safety and convenience of catheter development.

[0012] Further, step S3 is repeated according to the development requirements to perform multiple dip coatings. Through the above improvements, different usage scenarios have different requirements for development effects. Multiple dip coatings can be performed on the middle reinforcement layer to match different development requirements.

[0013] Preferably, the developing solution includes a TPU substrate, tungsten powder, and a solvent for dissolving the TPU substrate and the tungsten powder, and the tungsten powder accounts for 30%-70% of the weight of the developing solution. Through the above improvements, the proportion of tungsten powder can be adjusted as needed to meet different developing requirements.

[0014] Preferably, a developing solution is prepared before step S3, the TPU substrate, tungsten powder, and solvent are weighed according to the ratio, a certain amount of TPU substrate, tungsten powder, and solvent are placed in a mixing container, and are fully stirred to make the TPU substrate and tungsten powder completely dissolved in the solvent to form a developing solution. Through the above improvements, the TPU substrate, a certain amount of tungsten powder and an organic solvent are mixed, the organic solvent dissolves the TPU substrate and tungsten powder to form a developing solution, and the proportion of tungsten powder can be adjusted according to needs. The proportioned solution is dip-coated on the intermediate reinforcement layer, and the developing property of tungsten powder is used to form a developing layer on the intermediate reinforcement layer, so that the catheter has a developing function.

[0015] Compared with the prior art, the present invention has the following advantages and beneficial effects: The catheter is composed of an inner layer, an intermediate reinforcement layer, and an outer layer, wherein the inner layer, the intermediate reinforcement layer, and the outer layer are all made of PEEK material, thereby ensuring the biocompatibility and mechanical strength of the entire catheter. In addition, a developing solution is dip-coated on the intermediate reinforcement layer, and the developing solution is solidified to form a developing layer, so that the catheter has a good developing effect. The developing layer is tightly connected to the intermediate reinforcement layer, and the structure is more stable. Compared with the traditional method of putting a developing ring on the catheter for development, the developing ring will not be detached, so that the entire developing ring has higher safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a radial cross-sectional view of the overall structure of the present invention; Figure 2 It is an axial cross-sectional view of the overall structure of the present invention; Figure 3 It is an axonometric diagram of the overall structure of the present invention; In the figure: 1, inner layer; 2, middle reinforcing layer; 3, outer layer; 4, developing layer; 5, embedding hole; 6, cavity. DETAILED DESCRIPTION

[0017] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0018] It should be understood that although the terms upper, middle, lower, top, end, etc. appear in this article to describe various elements, these elements are not limited by these terms. These terms are only used to distinguish elements from each other for easy understanding, and are not used to define any direction or order limitation.

[0019] like Figure 1-3 As shown, the PEEK medical composite catheter containing the developing layer 4 includes an inner layer 1, a middle reinforcing layer 2, and an outer layer 3 which are sequentially arranged from inner to outer.

[0020] Specifically, the inner layer 1 , the middle reinforcement layer 2 , and the outer layer 3 are made of PEEK material, the inner layer 1 is hollow and forms a cavity 6 , and the middle reinforcement layer 2 is dipped with a developing solution, which is solidified to form a developing layer 4 .

[0021] The catheter is composed of an inner layer 1, an intermediate reinforcement layer 2, and an outer layer 3 which are sequentially arranged outside and inside. The inner layer 1, the intermediate reinforcement layer 2, and the outer layer 3 are all made of PEEK material, thereby ensuring the biocompatibility and mechanical strength of the entire catheter. In addition, a developing solution is dip-coated on the intermediate reinforcement layer 2, and the developing solution is solidified to form a developing layer 4, so that the catheter has a developing effect, and the developing layer 4 is tightly connected to the intermediate reinforcement layer 2. Compared with the traditional technology of sleeve-mounting a developing ring on the catheter for development, the developing ring will not be detached, so that the entire developing ring has higher safety.

[0022] As a further explanation of the developing solution, the developing solution is a TPU solution containing tungsten, that is, a solution mixed with tungsten powder and TPU material.

[0023] Among them, thermoplastic polyurethane elastomer (TPU) is a type of elastomer that can be plasticized by heating and dissolved by solvents. It has excellent comprehensive properties such as high strength, high toughness, wear resistance, and oil resistance, and has good processing performance. It is widely used in defense, medical, food and other industries. Tungsten is a common material used as a developing ring. Tungsten powder and TPU material are dissolved together in an organic solvent (such as ethyl acetate) and dip-coated on the intermediate reinforcing layer 2. As the developing solution solidifies, a developing layer 4 with excellent elasticity and developing properties will be formed on the intermediate reinforcing layer 2.

[0024] Compared with the traditional metal developing ring, the developing layer 4 in the present invention is elastically arranged and fixed on the surface of the middle reinforcing layer 2. It will not detach and cause blood vessel damage, and has excellent elasticity. The thickness is much smaller than the conventional developing ring, so it will not affect the flexibility of the catheter during use, and greatly improves the safety and convenience of use of the catheter.

[0025] In addition, unlike the conventional developing ring which needs to be set at the farthest end of the catheter, the developing layer 4 can be dip-coated at any position of the middle reinforcing layer 2, and the dipping area is not limited, which greatly improves the safety and convenience of catheter development.

[0026] As a further explanation of the outer layer 3 in this embodiment, the outer layer 3 is made of a PEEK heat shrink tube.

[0027] Among them, the PEEK heat shrink tube has excellent biocompatibility and excellent high and low temperature resistance. It can maintain flexibility at low temperatures, while withstanding short-term high temperatures of up to 300°C, and allows long-term use at 260°C. This material has good electrical insulation and mechanical properties, and a shrinkage rate of 1:1.4, ensuring its stability and reliability in various environments. The PEEK heat shrink tube can be heated to shrink and wrap around the middle reinforcement layer 2, thereby enhancing the protective effect and forming a tight connection with the middle reinforcement layer 2.

[0028] When the PEEK heat shrink tube shrinks and covers the middle reinforcing layer 2 , the PEEK heat shrink tube will fit the outer contour of the covering developing layer 4 , thereby further improving the stability of the developing layer 4 .

[0029] In some other embodiments, a PEEK solution may be dip-coated on the surface of the developing layer 4 , and the PEEK solution is cured to form the outer layer 3 .

[0030] During the molding process, the PEEK material can be dip-coated on the surface of the developing layer 4 and the intermediate reinforcing layer 2. The PEEK solution is heated and cured to form the outer layer 3, which can protect the entire intermediate reinforcing layer 2 and the developing layer 4 and form a tight connection.

[0031] As a further explanation of the implementation method of the intermediate reinforcement layer 2 in this embodiment, the intermediate reinforcement layer 2 is formed by three-dimensional weaving of PEEK wires, and the three-dimensional weaving of PEEK fiber filaments is used to provide additional strength and flexibility for the entire catheter.

[0032] In addition, the PEEK wires are interlaced and woven to form the middle reinforcing layer 2, so that a plurality of embedding holes 5 are formed between the PEEK wires, and the developing layer 4 is partially embedded in the embedding holes. As the developing solution is heated and melted, it will be embedded in the embedding holes, thereby greatly improving the tightness of the cooperation between the developing layer 4 and the middle reinforcing layer 2.

[0033] A method for preparing a PEEK medical composite catheter containing a developing layer 4 is also provided, comprising the following steps: S1 Inner layer 1 molding: high-purity PEEK particles are selected, the PEEK particles are heated to the melting point, and extruded through an extrusion device to form a PEEK tube, and the extruded PEEK tube is placed in a cooling water tank for cooling and shaping to form the inner layer 1 of the catheter; S2: Forming the intermediate reinforcement layer 2: PEEK fiber wire is selected as the material of the intermediate reinforcement layer 2, the PEEK wire is woven into the intermediate reinforcement layer 2 by a three-dimensional weaving device, and the woven intermediate reinforcement layer 2 is sleeved onto the inner layer 1 of the catheter; S3: forming the developing layer 4: immersing the inner layer 1 and the middle reinforcing layer 2 into the developing solution, so that the developing solution is evenly coated on the middle reinforcing layer 2; S4: After the dip coating is completed, the intermediate reinforcing layer 2 is placed in a baking device for drying and curing, so that the developing solution forms a developing layer 4 on the intermediate reinforcing layer 2; S5: Forming of outer layer 3: sleeve a PEEK heat shrink tube around the developing layer 4, or dip-coat a PEEK solution around the developing layer 4, and then use a baking device to shrink the PEEK heat shrink tube or solidify the PEEK solution to form the outer layer 3 of the catheter.

[0034] Further explanation of the developer solution dip coating, wherein the developer solution dip coating comprises the following steps: It is necessary to clean the surface oil stains of the intermediate reinforcement layer 2 before dipping in step S2; In step S3, before drying and curing, the dip-coated intermediate reinforcing layer 2 is taken out, and the developing solution on the intermediate reinforcing layer 2 is allowed to drip naturally.

[0035] The prepared developing solution is uniformly dip-coated on a specified area of ​​the middle reinforcing layer 2, and then drained and dried to solidify, so that the developing solution solidifies on the middle reinforcing layer 2 to form a developing layer 4. Compared with a traditional developing ring, the developing layer 4 not only has good elasticity and will not scratch the blood vessels, but also fits tightly with the middle reinforcing layer 2 and will not separate like the developing ring. In addition, unlike conventional developing rings that need to be set at the farthest end of the catheter, it can be dip-coated at any position of the middle reinforcing layer 2, and the dipping area is not limited, which greatly improves the safety and convenience of catheter development.

[0036] Furthermore, before step S4, step S3 is repeated, and dipping is performed multiple times according to the requirements of the development effect, so that the development layer 4 can achieve the required development effect.

[0037] Since different usage scenarios have different requirements for development effects, multiple dip coatings can be performed on the intermediate reinforcing layer 2 to match different development requirements.

[0038] In addition, the extrusion equipment is an extruder, and the baking equipment is an oven, which belong to the prior art and will not be described in detail.

[0039] As a further implementation of the developing solution ratio, the developing solution includes a TPU substrate, tungsten powder, and a solvent for dissolving the TPU substrate and the tungsten powder, and the tungsten powder accounts for 30%-70% of the weight of the developing solution. The proportion of the tungsten powder can be adjusted according to the developing requirements to meet different developing requirements.

[0040] For example, TPU substrate: 100 g; Tungsten powder: add 30%-70% by weight (the specific ratio is adjusted according to the development effect requirements); Solvent: appropriate amount, sufficient to completely dissolve the TPU substrate and tungsten powder; Specifically, the preparation of the developing solution includes the following steps: The TPU substrate, tungsten powder, and solvent are weighed according to the ratio, and a certain amount of TPU substrate, tungsten powder, and solvent are placed in a mixing container and stirred sufficiently to completely dissolve the TPU substrate and tungsten powder in the solvent to form a developing solution.

[0041] During the entire preparation process, the TPU substrate, a certain amount of tungsten powder and an organic solvent are mixed. The organic solvent dissolves the TPU substrate and the tungsten powder to form a developing solution, and the proportion of the tungsten powder can be adjusted according to demand. The prepared solution is dip-coated on the intermediate reinforcing layer 2, and the developing property of the tungsten powder is utilized to form a developing layer 4 on the intermediate reinforcing layer 2, thereby giving the catheter a developing function.

[0042] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.

Claims

1. A PEEK medical composite catheter with a developing layer, characterized in that: It comprises an inner layer (1), an intermediate reinforcement layer (2), and an outer layer (3) which are sequentially arranged inside and outside; The inner layer (1), the middle reinforcement layer (2), and the outer layer (3) are made of PEEK material, and the middle reinforcement layer (2) is dip-coated with a developing solution, which is solidified to form a developing layer (4).

2. The PEEK medical composite catheter with a developing layer according to claim 1, characterized in that: The developing solution is a TPU solution containing tungsten.

3. The PEEK medical composite catheter with a developing layer according to claim 1, characterized in that: The surface of the developing layer (4) is dip-coated with a PEEK solution, the PEEK solution is solidified and forms an outer layer (3), or the outer layer (3) is formed by a PEEK heat shrink tube.

4. The PEEK medical composite catheter with a developing layer according to claim 1, characterized in that: The intermediate reinforcement layer (2) is formed by three-dimensionally weaving PEEK wires.

5. The PEEK medical composite catheter with a developing layer according to claim 4, characterized in that: A plurality of embedding holes (5) are formed between the PEEK wires, and the developing layer (4) is partially embedded in the embedding holes.

6. The method for preparing a PEEK medical composite catheter containing a developing layer according to any one of claims 1 to 5, characterized in that: The steps include: S1 Inner layer (1) molding: PEEK particles are heated to a melting point and extruded through an extrusion device to form a PEEK tube, and the extruded PEEK tube is placed in a cooling water tank for cooling and shaping to form the inner layer (1) of the catheter; S2: forming the intermediate reinforcement layer (2): weaving the PEEK wire into the intermediate reinforcement layer (2) through a three-dimensional weaving device, and sleeve-connecting the completed weaving intermediate reinforcement layer (2) to the outside of the inner layer (1); S3 forming the developing layer (4): immersing the intermediate reinforcing layer (2) in a developing solution, so that the developing solution is evenly coated on the intermediate reinforcing layer (2); S4: shaping the developing layer (4): after the dip coating is completed, the intermediate reinforcing layer (2) is placed in a baking device for drying and curing, so that the developing solution is dried and cured on the intermediate reinforcing layer (2) to form a developing layer (4); S5: forming the outer layer (3): sleeve a PEEK heat shrink tube on the outer periphery of the developing layer (4), or dip-coat a PEEK solution on the outer periphery of the developing layer (4), and then use a baking device to shrink the PEEK heat shrink tube or solidify the PEEK solution to form the outer layer (3) of the catheter.

7. The method for preparing a PEEK medical composite catheter containing a developing layer according to claim 6, characterized in that: In step S2, the surface oil stains of the middle reinforcement layer (2) are cleaned; In step S3, the intermediate reinforcing layer (2) after the dip coating is taken out, and the developing solution on the intermediate reinforcing layer (2) is allowed to drip naturally.

8. The method for preparing a PEEK medical composite catheter containing a developing layer according to claim 7, characterized in that: Step S3 is repeated according to the development requirements to perform multiple dip coatings.

9. The method for preparing a PEEK medical composite catheter containing a developing layer according to claim 6, characterized in that: The developing solution includes a TPU substrate, tungsten powder, and a solvent for dissolving the TPU substrate and the tungsten powder, and the tungsten powder accounts for 30%-70% of the weight of the developing solution.

10. The method for preparing the PEEK medical composite catheter containing a developing layer according to claim 9, characterized in that: Before step S3, a developing solution is prepared, the TPU substrate, tungsten powder, and solvent are weighed according to the ratio, a certain amount of TPU substrate, tungsten powder, and solvent are placed in a mixing container, and stirred sufficiently to make the TPU substrate and tungsten powder completely dissolved in the solvent to form a developing solution.

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