PEEK Medical Composite Catheter with Development Markers and Its Preparation Method

Abstract

The present invention discloses a PEEK medical composite catheter with a developing mark, which includes an inner layer, an intermediate reinforcing layer, and an outer layer sequentially arranged from the inside to the outside, and the inner layer, the intermediate reinforcing layer, and the outer layer are all made of PEEK material; the intermediate reinforcing layer is formed by interlacing PEEK wires, connection gaps are formed between the PEEK wires, and a developing unit is embedded in the connection gaps, and the developing unit is arranged along a defined path and forms a specified developing pattern, thereby greatly improving the developing effect to ensure the safety of the catheter during use.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a PEEK medical composite catheter with a developing marker and a preparation method thereof. Background Art

[0002] In the field of human interventional therapy, medical catheters are commonly used medical tools. In cerebrovascular interventional surgery, catheter products are mainly responsible for building the surgical access path, delivering implantable devices, injecting diagnostic reagents, and directly aspirating thrombus, and their usage frequency is very high.

[0003] During interventional surgery, doctors need to monitor the position of the catheter in real time. However, existing catheters often need to rely on external markers to observe their positions under X-rays, which greatly increases the surgical difficulty and risk. Summary of the Invention

[0004] To solve the technical problems in the background art, the present invention provides a PEEK medical composite catheter with a developing marker and a preparation method thereof.

[0005] The technical solution adopted by the present invention to solve its technical problems is as follows:

[0006] A PEEK medical composite catheter with a developing marker includes an inner layer, an intermediate reinforcing layer, and an outer layer sequentially arranged from the inside to the outside, and the inner layer, the intermediate reinforcing layer, and the outer layer are all made of PEEK material;

[0007] The intermediate reinforcing layer is formed by interweaving PEEK wires, and connection gaps are formed between the PEEK wires. A developing unit is embedded in the connection gaps, and the developing units are arranged along a defined path to form a specified developing pattern.

[0008] Preferably, the developing units are evenly distributed along the length direction of the intermediate reinforcing layer. Through the above improvement, the developing units are evenly distributed throughout the entire length of the catheter, so as to ensure that the position of the entire catheter can be clearly seen under X-rays during the operation, thereby greatly reducing the difficulty and risk of the operation, and improving the convenience of the doctor's operation and the success rate of the operation.

[0009] Preferably, the intermediate reinforcing layer has a conventional developing area extending horizontally and a key developing area with a turning or bifurcated setting, and the number of developing units arranged in the key developing area is greater than that in the conventional developing area. Through the above improvement, the number of developing units can be arbitrarily controlled. Among them, the turning and branching points of the catheter are more critical than the conventional areas during the operation, so the number of developing units can be increased to distinguish the conventional developing area and the key developing area, further improving the positioning accuracy.

[0010] Preferably, the developing unit is sprayed or injected into the connection gap and welded to the PEEK wire. Through the above improvement, when the developing unit is embedded in the connection gap and undergoes a high-temperature melting process, the developing unit is tightly combined with the PEEK, which not only ensures the reliability of the installation of the developing unit but also further enhances the structural strength of the intermediate reinforcing layer.

[0011] The present invention also provides a method for preparing a PEEK medical composite catheter with a developing mark, comprising the following steps:

[0012] S1 Inner layer forming: Heating PEEK particles to the melting point and extruding them through an extrusion device to form a PEEK pipe, and placing the extruded PEEK pipe into a cooling water tank for cooling and shaping to form the inner layer of the catheter.

[0013] S2 Intermediate reinforcing layer forming: Setting up a three-dimensional braiding device, braiding PEEK wires through the three-dimensional braiding device to form an intermediate reinforcing layer, and sleeving the completed braided intermediate reinforcing layer outside the inner layer.

[0014] S3 Developing unit embedding: Uniformly distributing the developing mark to the connection gap by spraying or injection.

[0015] S4 Developing unit fixing: Setting up a heating device, placing the embedded intermediate reinforcing layer into the heating device for high-temperature melting to tightly combine the developing unit with the PPEK wire.

[0016] S5 Outer layer forming: Setting up a baking device, sleeving a PEEK heat shrinkable tube outside the developing layer, or dip-coating a PEEK solution outside the developing layer, and then using the baking device to shrink the PEEK heat shrinkable tube or cure the PEEK solution to form the outer layer of the catheter.

[0017] Preferably, the developing unit comprises a mixture of BaSO4, W, and Bi2O3, and a polymer material for dissolving the mixture of BaSO4, W, and Bi2O3. Through the above improvement, barium sulfate (BaSO4): has good X-ray impermeability and good biocompatibility, tungsten powder (W): has a high density and strong X-ray impermeability, bismuth compound (Bi2O3): has a high density, good X-ray impermeability, and relatively good biocompatibility. Mixing the above materials with the polymer material to form a developing material for making the developing unit, so that the developing unit has good developability and biocompatibility, and using the polymer material to enhance the reliability of connection with the intermediate reinforcing layer.

[0018] Preferably, a developing unit is prepared before step S3. BaSO4, W, Bi2O3, and a polymer material are mixed according to a ratio, so that a quantitative BaSO4, W, Bi2O3 and the polymer material are blended to form a developing material for manufacturing the developing unit. Through the above improvement, the quantitatively formulated BaSO4, W, Bi2O3 and the polymer material are mixed and constitute the developing material for manufacturing the developing unit, ensuring the developing effect and biocompatibility of the developing unit.

[0019] Preferably, the polymer material is pebax or PA. Through the above improvement, by utilizing the material properties of pebax or PA, the mixed developing material can be better melted with the intermediate reinforcing layer, ensuring the reliability of the installation of the developing unit.

[0020] Preferably, the BaSO4 is added at a weight ratio of 30%-70%, the W is added at a weight ratio of 10%-20%, and the Bi2O3 is added at a weight ratio of 10%-20%. Through the above improvement, the developability and biocompatibility of the developing material are ensured, and the ratio can be adjusted according to the developing requirements to match different developing scenarios.

[0021] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0022] A catheter is formed by an inner layer, an intermediate reinforcing layer, and an outer layer. Among them, the inner layer, the intermediate reinforcing layer, and the outer layer are all made of PEEK material, ensuring the biocompatibility and mechanical strength of the entire catheter. And by embedding a developing unit in the connection gap of the intermediate reinforcing layer, the catheter has a good developing effect, and the developing units can be arranged according to a defined path, and a specified developing pattern is formed by combining points, increasing the visual effect under X-ray, greatly improving the developing effect, so as to ensure the safety of the catheter during use. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a cross-sectional view of the overall structure of the present invention;

[0024] Figure 2 is a schematic structural view of the intermediate reinforcing layer of the present invention;

[0025] Figure 3 is an axonometric view of the overall structure of the present invention;

[0026] In the figure: 1, inner layer; 2, intermediate reinforcing layer; 3, outer layer; 4, developing unit; 5, connection gap. DETAILED DESCRIPTION OF THE INVENTION

[0027] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0028] It should be understood that although terms such as upper, middle, lower, top, one 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, rather than for defining any directional or sequential limitations.

[0029] As Figures 1-3 shown, a PEEK medical composite catheter with a developing mark includes an inner layer 1, a middle reinforcing layer 2, and an outer layer 3 arranged in sequence from the inside to the outside, and the inner layer 1, the middle reinforcing layer 2, and the outer layer 3 are all made of PEEK material.

[0030] Specifically, the middle reinforcing layer 2 is formed by interlacing PEEK wires, a connection gap 5 is formed between the PEEK wires, and a developing unit 4 is embedded in the connection gap 5. The developing unit 4 is arranged along a defined path and forms a specified developing pattern.

[0031] By embedding the developing unit 4 in the connection gap 5, the developing property of the developing unit 4 is used to make the catheter have a developing effect, and the developing unit 4 is arranged along a defined path, combined to form different developing shapes, and the visual effect under X-ray is optimized, thereby greatly improving the developing effect to ensure the safety of the catheter during use.

[0032] In addition, embedding the developing unit 4 on the middle reinforcing layer 2 can further enhance the structural strength of the middle reinforcing layer 2, and compared with the traditional method of using a developing ring for developing, it is not easy to fall off, has a high safety factor, and can arbitrarily set the developing area to improve the developing effect.

[0033] As Figures 1-3 shown, for a further explanation of the installation of the developing unit 4, the developing unit 4 is uniformly distributed along the length direction of the middle reinforcing layer 2.

[0034] By uniformly distributing the developing unit 4 throughout the entire length of the catheter, it is ensured that during the operation, the position of the entire catheter can be clearly seen under X-ray, thereby greatly reducing the difficulty and risk of the operation, and improving the convenience of the doctor's operation and the success rate of the operation.

[0035] Specifically, the middle reinforcement layer 2 has a horizontally extending conventional development area and a key development area arranged in a bent or bifurcated manner. The number of developing units 4 arranged on the key development area is greater than that on the conventional development area.

[0036] During the operation, the key development area arranged in a bent or bifurcated manner is more critical than the conventional development area, so that the number of developing units 4 can be increased to distinguish the conventional development area from the key development area, thereby further improving the positioning accuracy and the development effect.

[0037] As Figures 1-3 shown, as a further explanation of the installation of the developing unit 4, the developing unit 4 is sprayed or injected into the connection gap 5 and welded to the PEEK wire.

[0038] When the developing unit 4 is embedded in the connection gap 5 and undergoes a high-temperature melting process, the developing unit 4 is tightly combined with the PEEK, which not only ensures the reliability of the installation of the developing unit 4, but also further improves the structural strength of the middle reinforcement layer 2.

[0039] Preferably, the developing unit 4 is made of a material with high density and good biocompatibility. The high density of the material can ensure the impermeability to X-rays, and the good biocompatibility can avoid damage to the human body and improve the safety of the catheter during use.

[0040] As Figures 1-3 shown, a method for preparing a PEEK medical composite catheter with a developing mark is also provided, including the following steps:

[0041] S1 Inner layer 1 forming: Heat the PEEK particles to the melting point and extrude them through an extrusion device to form a PEEK pipe. Place the extruded PEEK pipe into a cooling water tank for cooling and shaping to form the inner layer 1 of the catheter.

[0042] S2 Middle reinforcement layer 2 forming: Use a three-dimensional braiding device to braid the PEEK wire into the middle reinforcement layer 2 through the three-dimensional braiding device, and sleeved the completed braided middle reinforcement layer 2 outside the inner layer 1.

[0043] S3 Developing unit 4 embedding: Uniformly distribute the developing mark to the connection gap 5 by spraying or injecting.

[0044] S4 Developing unit 4 fixing: Use a heating device to place the embedded middle reinforcement layer 2 into the heating device for high-temperature melting, so that the developing unit 4 is tightly combined with the PPEK wire, and a specified developing pattern is formed on the middle reinforcement layer 2.

[0045] Forming of the outer layer 3 of S5: Using a baking device, a PEEK heat-shrinkable tube is sleeved around the outer periphery of the intermediate reinforcing layer 2, or a PEEK solution is dip-coated around the outer periphery of the intermediate reinforcing layer 2, and then the PEEK heat-shrinkable tube is shrunk or the PEEK solution is cured through the baking device to form the outer layer 3 of the catheter;

[0046] Final product inspection of S6: Conduct biocompatibility testing, mechanical property testing, and imaging effect testing on the finished catheter.

[0047] Before step S3, it is necessary to prepare the imaging unit 4. According to the ratio, BaSO4, W, Bi2O3, and a polymer material are mixed so that a quantitative amount of BaSO4, W, Bi2O3 and the polymer material are blended to form an imaging material for manufacturing the imaging unit 4.

[0048] During the production process of the imaging material, a quantitative amount of BaSO4, W, Bi2O3 and the polymer material are mixed and form an imaging material for manufacturing the imaging unit 4, ensuring the imaging effect and biocompatibility of the imaging unit 4.

[0049] Specifically, barium sulfate (BaSO4): has good X-ray opacity and good biocompatibility; tungsten powder (W): has a high density and strong X-ray opacity, bismuth compound (Bi2O3): has a high density, good X-ray opacity, and relatively good biocompatibility. The above materials are mixed with the polymer material to form an imaging material for manufacturing the imaging unit 4, so that the imaging unit 4 has good imaging properties and biocompatibility, and the reliability of connection with the intermediate reinforcing layer 2 is improved by using the polymer material.

[0050] Among them, the polymer material is pebax or PA. Utilizing the material properties of pebax or PA, the mixed imaging material can be better melted with the intermediate reinforcing layer 2, ensuring the reliability of the installation of the imaging unit 4.

[0051] The Pebax material is a block copolymer prepared from polyether and polyamide blocks, with a unique chemical structure and excellent properties. And the Pebax material belongs to engineering polymers and is a thermoplastic elastomer without plasticizers, having a wide range of hardness and good resilience. Its excellent low-temperature impact resistance and kinetic properties enable it to maintain excellent flexural fatigue strength and resilience at various temperatures, so that it can be better melted with the intermediate reinforcing layer 2. Not only does it ensure the reliability of the fixed installation of the imaging unit 4, but also using its excellent resilience performance, the imaging unit 4 can deform along with the intermediate reinforcing layer 2 when turning.

[0052] In addition, PA material (polyamide, abbreviated as PA) has a variety of excellent properties, including high strength, wear resistance, corrosion resistance and self-lubrication. PA material also exhibits good corrosion resistance, being able to resist alkalis and most salt solutions, and is also resistant to weak acids, machine oils, gasoline, aromatic compounds and general solvents. In addition, PA material has relatively high mechanical strength and toughness, with tensile and compressive strengths higher than those of general plastics, and impact strength superior to that of acetal resin, thus enabling the developing unit 4 to better cooperate with the intermediate reinforcing layer 2.

[0053] Preferably, BaSO4 is added in a weight ratio of 30%-70%, W is added in a weight ratio of 10%-20%, and Bi2O3 is added in a weight ratio of 10%-20%, ensuring the developability and biocompatibility of the developing material, and the ratio can be adjusted according to the developing requirements to match different developing scenarios.

[0054] This specific embodiment is only an explanation of the present invention and is not a limitation thereof. Those skilled in the art can make modifications to this embodiment without creative contributions according to needs after reading this specification, but as long as it is within the scope of the claims of the present invention, it is protected by the patent law.

Claims

1. A PEEK medical composite catheter with a development mark, characterized in that, It includes an inner layer (1), an intermediate reinforcing layer (2), and an outer layer (3) arranged in sequence from the inside out, and the inner layer (1), the intermediate reinforcing layer (2), and the outer layer (3) are all made of PEEK material; The intermediate reinforcing layer (2) is formed by interweaving PEEK wires, connection gaps (5) are formed between the PEEK wires, and a developing unit (4) is embedded in the connection gaps (5), and the developing unit (4) is arranged along a defined path to form a specified developing pattern; The intermediate reinforcing layer (2) has a conventional developing area extending horizontally, and a key developing area with a turning or bifurcated setting, and the number of developing units (4) arranged on the key developing area is greater than that on the conventional developing area. The developing unit (4) is sprayed or injected into the connection gap (5) and welded to the PEEK wire.

2. The PEEK medical composite catheter with a developing marker according to claim 1, characterized in that The developing units (4) are evenly distributed along the length direction of the intermediate reinforcing layer (2).

3. The preparation method of the PEEK medical composite catheter with a development mark according to any one of claims 1-2, characterized in that, It includes the following steps: S1 Inner layer (1) forming: Heat the PEEK particles to the melting point, and extrude them through an extrusion device to form a PEEK pipe. Put the extruded PEEK pipe into a cooling water tank for cooling and shaping to form the inner layer (1) of the catheter; S2 Intermediate reinforcing layer (2) forming: Set up a three-dimensional braiding device, braid the PEEK wires into the intermediate reinforcing layer (2) through the three-dimensional braiding device, and sleeved the completed braided intermediate reinforcing layer (2) outside the inner layer (1); S3 Developing unit (4) embedding: Uniformly distribute the developing marks to the connection gaps (5) by spraying or injecting; S4 Developing unit (4) fixing: Set up a heating device, put the embedded intermediate reinforcing layer (2) into the heating device for high-temperature melting, so that the developing unit (4) is tightly combined with the PPEK wire, and a specified developing pattern is formed on the intermediate reinforcing layer (2); S5 Outer layer (3) forming: Set up a baking device, sleeved a PEEK heat shrinkable tube on the outer periphery of the intermediate reinforcing layer (2), or dip-coat a PEEK solution on the outer periphery of the intermediate reinforcing layer (2), and then make the PEEK heat shrinkable tube shrink or make the PEEK solution solidify through the baking device to form the outer layer (3) of the catheter.

4. The preparation method of the PEEK medical composite catheter with a developing mark according to claim 3, characterized in that: The developing unit (4) includes a mixture of BaSO4, W, and Bi2O3, and a polymer material for dissolving the mixture of BaSO4, W, and Bi2O3.

5. The preparation method of the PEEK medical composite catheter with a developing marker according to claim 4, wherein, The developing unit (4) is prepared before step S3. According to the ratio, BaSO4, W, Bi2O3, and the polymer material are mixed, so that a quantitative BaSO4, W, Bi2O3 and the polymer material are blended to form a developing material for making the developing unit (4).

6. The preparation method of the PEEK medical composite catheter with a development mark according to claim 4, characterized in that, The polymer material is PEBAX or PA.

7. The preparation method of the PEEK medical composite catheter with a development mark according to claim 4, characterized in that, The BaSO4 is added in a weight ratio of 30% - 70%, the W is added in a weight ratio of 10% - 20%, and the Bi2O3 is added in a weight ratio of 10% - 20%.

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