PEEK medical composite catheter with developing mark and preparation method of PEEK medical composite catheter

Abstract

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, and the inner layer, the middle reinforcing layer and the outer layer are all made of PEEK materials; the middle reinforcing layer is formed by weaving PEEK lines in a staggered mode, connecting gaps are formed between the PEEK lines, developing units are embedded in the connecting gaps, and the developing units are arranged according to a limited path and form a specified developing graph, so that the developing effect is greatly improved, and the safety of the catheter in the using process is guaranteed.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a PEEK medical composite catheter with a developing mark 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] During interventional surgery, doctors need to monitor the position of the catheter in real time. However, existing catheters often require external markings to observe their position under X-rays, which greatly increases the difficulty and risk of the surgery. 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 with a development mark and a preparation method thereof.

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

[0006] A PEEK medical composite catheter with a development mark comprises an inner layer, an intermediate reinforcement layer, and an outer layer which are sequentially arranged inside and outside, and the inner layer, the intermediate reinforcement layer, and the outer layer are all made of PEEK material;

[0007] The intermediate reinforcement layer is formed by interlacing and weaving PEEK lines, connecting gaps are formed between the PEEK lines, and developing units are embedded in the connecting gaps. The developing units are arranged according to a defined path and form a specified developing pattern.

[0008] Preferably, the developing units are evenly distributed along the length direction of the middle reinforcement layer. Through the above improvements, the developing units are evenly distributed over the entire length of the catheter, thereby ensuring that during the operation, the position of the entire catheter can be clearly seen under X-rays, thereby greatly reducing the difficulty and risk of manual operation, and improving the convenience of the doctor's operation and the success rate of the operation.

[0009] Preferably, the intermediate reinforcement layer has a horizontally extending conventional developing area and a key developing area that is arranged at a bend or a fork, and the number of developing units arranged in the key developing area is greater than that in the conventional developing area. Through the above improvements, the number of developing units can be arbitrarily controlled, wherein the bends and branches of the catheter are more critical than the conventional areas in the operation, so the number of developing units can be increased to distinguish the conventional developing area from the key developing area, further improving the positioning accuracy.

[0010] Preferably, the developing unit is sprayed or injected into the connecting gap and fused with the PEEK wire. Through the above improvements, when the developing unit is embedded in the connecting gap and undergoes a high-temperature melting process, the developing unit and PEEK are tightly combined, which not only ensures the reliability of the installation of the developing unit, but also further improves the structural strength of the intermediate reinforcement layer.

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

[0012] 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;

[0013] S2 Middle reinforcement layer forming: set up a three-dimensional braiding device, weave the PEEK wire into the middle reinforcement layer through the three-dimensional braiding device, and sleeve the completed braided middle reinforcement layer onto the outside of the inner layer;

[0014] S3 developer unit embedding: the developer mark is evenly distributed to the connection gap by spraying or injection;

[0015] S4 developer unit fixation: set up a heating device, put the embedded intermediate reinforcement layer into the heating device for high-temperature melting, so that the developer unit is closely combined with the PPEK line;

[0016] S5 outer layer molding: a baking device is provided, a PEEK heat shrink tube is sleeved on the periphery of the developing layer, or a PEEK solution is dipped on the periphery of the developing layer, and then the PEEK heat shrink tube is shrunk or the PEEK solution is solidified by the baking device to form the outer layer of the catheter.

[0017] Preferably, the developing unit includes a mixture of BaSO4, W, and Bi2O3, and a polymer material for dissolving the mixture of BaSO4, W, and Bi2O3. Through the above improvements, barium sulfate (BaSO4) has good X-ray opacity and good biocompatibility, tungsten powder (W) has high density and strong X-ray opacity, and bismuth compound (Bi2O3) has high density, good X-ray opacity and good biocompatibility. The above materials are mixed 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 the polymer material is used to improve the reliability of the connection with the intermediate reinforcement layer.

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

[0019] Preferably, the polymer material is pebax or PA. Through the above improvements, the material properties of pebax or PA are utilized so that the mixed developing material can be better melted with the middle reinforcing layer, thereby ensuring the reliability of the development unit installation.

[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 improvements, the developability and biocompatibility of the developing material are guaranteed, and the ratio can be adjusted according to the development requirements to suit different development scenarios.

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

[0022] 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, and by embedding a developing unit in the connection gap of the intermediate reinforcement layer, the catheter has a good developing effect, and the developing unit can be arranged according to a defined path, and a designated developing pattern is formed by a combination of points, thereby increasing the visual effect under X-rays, greatly improving the developing effect, and ensuring the safety of the catheter during use. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0024] Figure 2 It is a schematic structural diagram of the middle reinforcement layer of the present invention;

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

[0026] In the figure: 1, inner layer; 2, middle reinforcing layer; 3, outer layer; 4, developing unit; 5, connecting gap. DETAILED DESCRIPTION

[0027] 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.

[0028] 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.

[0029] like Figure 1-3 As shown, the PEEK medical composite catheter with a development mark includes an inner layer 1, a middle reinforcement layer 2, and an outer layer 3 which are arranged in sequence inside and outside, and the inner layer 1, the middle reinforcement layer 2, and the outer layer 3 are all made of PEEK material.

[0030] Specifically, the middle reinforcing layer 2 is formed by interlacing and weaving PEEK lines, connecting gaps 5 are formed between the PEEK lines, and developing units 4 are embedded in the connecting gaps 5. The developing units 4 are arranged along a defined path and form a specified developing pattern.

[0031] By embedding the developing unit 4 on the connecting gap 5, the developing property of the developing unit 4 is utilized to make the catheter have a developing effect, and the developing units 4 are arranged according to a defined path to form different developing shapes in combination, 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, the developing unit 4 embedded in the middle reinforcing layer 2 can further enhance the structural strength of the middle reinforcing layer 2, and compared with the traditional development using a developing ring, it is not easy to fall off, has a high safety factor, and the developing area can be set arbitrarily to improve the developing effect.

[0033] like Figure 1-3 As shown, further explanation about the installation of the developing unit 4 is that the developing units 4 are evenly distributed along the length direction of the middle reinforcing layer 2 .

[0034] By evenly distributing the developing units 4 over 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-rays, thereby greatly reducing the difficulty and risk of manual operation, and improving the convenience of the doctor's operation and the success rate of the operation.

[0035] Specifically, the middle reinforcing layer 2 has a horizontally extending conventional developing area and a bent or bifurcated focused developing area, and the number of developing units 4 arranged in the focused developing area is greater than that in the conventional developing area.

[0036] During the operation, the key developing area set at the bend or fork is more critical than the conventional developing area, so the number of developing units 4 can be increased to distinguish the conventional developing area from the key developing area, thereby further improving the positioning accuracy and the developing effect.

[0037] like Figure 1-3 As shown, as a further explanation of the installation of the developing unit 4, the developing unit 4 is sprayed or injected into the connecting gap 5 and fused with 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 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 reinforcing layer 2 .

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

[0040] like Figure 1-3 As shown, a method for preparing a PEEK medical composite catheter with a development mark is also provided, comprising the following steps:

[0041] 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;

[0042] S2 Forming of the intermediate reinforcement layer 2: Using a three-dimensional braiding device, the PEEK wire is braided into the intermediate reinforcement layer 2 through the three-dimensional braiding device, and the braided intermediate reinforcement layer 2 is sleeved onto the outside of the inner layer 1;

[0043] S3: embedding the developing unit 4: evenly distributing the developing mark to the connection gap 5 by spraying or injecting;

[0044] S4: fix the developing unit 4: put the embedded intermediate reinforcing layer 2 into the heating device for high-temperature melting, so that the developing unit 4 is closely combined with the PPEK line, so that the designated developing pattern is formed on the intermediate reinforcing layer 2;

[0045] S5 outer layer 3 forming: using a baking device, sleeve a PEEK heat shrink tube on the outer periphery of the middle reinforcement layer 2, or dip-coat a PEEK solution on the outer periphery of the middle reinforcement layer 2, 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;

[0046] S6 Finished product testing: Conduct biocompatibility testing, mechanical property testing, and development effect testing on finished catheters.

[0047] Before step S3 , the developing unit 4 needs to be prepared, and BaSO 4 , W, Bi 2 O 3 , and a polymer material are mixed according to a ratio so that a certain amount of BaSO 4 , W, Bi 2 O 3 and the polymer material are blended to form a developing material for making the developing unit 4 .

[0048] In the process of making the developing material, the quantitatively matched BaSO4, W, Bi2O3 are mixed with the polymer material to form the developing material for manufacturing the developing unit 4, so as to ensure the developing effect and biocompatibility of the developing unit 4.

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

[0050] The polymer material is pebax or PA. By utilizing the material properties of pebax or PA, the mixed developing material can be better melted with the middle reinforcing layer 2, thereby ensuring the reliability of the installation of the developing unit 4.

[0051] Pebax material is a block copolymer prepared from polyether and polyamide blocks with a unique chemical structure and excellent properties. Pebax material is an engineering polymer and a plasticizer-free thermoplastic elastomer with a wide hardness range and good resilience. Its excellent low-temperature impact resistance and dynamic properties enable it to maintain excellent bending fatigue strength and resilience at all temperatures, so that it can be better melted with the intermediate reinforcement layer 2, not only ensuring the reliability of the fixed installation of the developing unit 4, but also utilizing its excellent resilience to enable the developing unit 4 to bend and deform with the intermediate reinforcement layer 2.

[0052] In addition, PA material (polyamide, PA for short) has many excellent properties, including high strength, wear resistance, corrosion resistance and self-lubrication. PA material also exhibits good corrosion resistance and can resist alkali and most salt solutions. It is also resistant to weak acids, engine oil, gasoline, aromatic compounds and general solvents. In addition, PA material has high mechanical strength and toughness, and its tensile and compressive strengths are higher than those of general plastics, and its impact strength is better than that of acetal resin, so that the developing unit 4 can better cooperate with the intermediate reinforcing layer 2.

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

[0054] 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 development mark, characterized in that: It comprises an inner layer (1), an intermediate reinforcement layer (2), and an outer layer (3) which are arranged in sequence, and the inner layer (1), the intermediate reinforcement layer (2), and the outer layer (3) are all made of PEEK material; The intermediate reinforcement layer (2) is formed by interlacing and weaving PEEK threads, connecting gaps (5) are formed between the PEEK threads, and developing units (4) are embedded in the connecting gaps (5). The developing units (4) are arranged along a defined path and form a specified developing pattern.

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

3. The PEEK medical composite catheter with development marking according to claim 1, characterized in that: The intermediate reinforcing layer (2) has a horizontally extending conventional developing area and a bent or bifurcated focused developing area, and the number of developing units (4) arranged in the focused developing area is greater than that in the conventional developing area.

4. The PEEK medical composite catheter with a development mark according to claim 1, characterized in that: The developing unit (4) is sprayed or injected into the connecting gap (5) and is welded to the PEEK wire.

5. A method for preparing a PEEK medical composite catheter with a development mark as claimed in any one of claims 1 to 4, 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): setting a three-dimensional braiding device, braiding the PEEK wire into the intermediate reinforcement layer (2) through the three-dimensional braiding device, and sleeve-connecting the braided intermediate reinforcement layer (2) to the outside of the inner layer (1); S3: embedding the developing unit (4): evenly distributing the developing mark to the connection gap (5) by spraying or injecting; S4: fixing the developing unit (4): setting a heating device, placing 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 line, so that a specified developing pattern is formed on the intermediate reinforcing layer (2); S5: Forming of the outer layer (3): Setting a baking device, sleeve a PEEK heat shrink tube on the periphery of the intermediate reinforcement layer (2), or dip-coating a PEEK solution on the periphery of the intermediate reinforcement layer (2), and then using the baking device to shrink the PEEK heat shrink tube or solidify the PEEK solution to form the outer layer (3) of the catheter.

6. The method for preparing the PEEK medical composite catheter with a development mark according to claim 5, characterized in that: The developing unit (4) comprises a mixture of BaSO4, W and Bi2O3, and a polymer material for dissolving the mixture of BaSO4, W and Bi2O3.

7. The method for preparing the PEEK medical composite catheter with a development mark according to claim 6, characterized in that: Before step S3, a developing unit (4) is prepared, and BaSO4, W, Bi2O3, and a polymer material are mixed according to a ratio, so that a certain amount of BaSO4, W, Bi2O3 and the polymer material are blended to form a developing material for making the developing unit (4).

8. The method for preparing the PEEK medical composite catheter with a development mark according to claim 6, characterized in that: The polymer material is pebax or PA.

9. The method for preparing the PEEK medical composite catheter with a development mark according to claim 6, characterized in that: 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%.

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