Preparation method of medical implant
By plasma treatment of polymer fibers and dip coating in polymer elastomer solution, combined with ultrasonic treatment, the problem of incomplete penetration of the coating inside the fiber braid is solved, and the bonding force between the fiber and the coating and the overall performance of the material is improved.
Patent Information
- Application Number
- CN202311763221.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-20
- Publication Date
- 2025-06-20
AI Technical Summary
Prior art When preparing medical implants such as artificial heart valves, the fabric after fiber braiding cannot completely penetrate the coating, resulting in weakening of binding force, thermal compression damage and hole defects, affecting material performance.
By plasma treatment of the polymer fibers, the specific surface area of the fiber surface is increased and the active groups are introduced to improve surface energy; then the plasma-treated fibers are placed in a polymer elastomer solution for dip coating, combined with ultrasonic treatment, ensuring that the coating completely penetrates the fiber surface and internal pores.
It improves the bonding force between the fiber and the coating, enhances the strength of the fiber, reduces the risk of breakage and defects, ensures the integrity and stability of the coating, and improves the performance of the material.
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Figure CN120174628A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical materials, and particularly to a preparation method of a medical implant. Background Art
[0002] Since the use of polymer materials for artificial valve implantation in the human body in the 1960s of last century, due to the biodegradation and mechanical property failure of early polymer materials in vivo, the development of polymer materials applied to artificial valves has been restricted. With the rapid development of polymer material technology in recent years, a new generation of polymer materials with biocompatibility and biological stability has emerged continuously, making polymer materials show good application prospects in the field of artificial heart valves.
[0003] Compared with the currently widely used artificial valve materials, pyrolytic carbon and animal pericardium, polymer materials simultaneously concentrate the advantages of the two materials, such as excellent biocompatibility, hydrodynamic performance, and fatigue resistance. In addition, the easy processability of polymer materials can realize a fully automated processing technology through various methods such as solution impregnation, melt injection molding, and 3D printing, greatly improving the stability of product production, reducing the manpower requirement and manufacturing cost.
[0004] Polymer fiber materials are widely used in medical implant materials due to their excellent mechanical strength, and at the same time, their flexible weaving process can endow the woven materials with good flexibility. These characteristics make polymer fibers have the potential to become ideal valve materials. For example, the prior art reported the first valve material prepared from polymer fiber materials. It prepared aortic valve leaflets using a polytetrafluoroethylene fiber woven cloth and implanted them into four patients, and 3 of the patients survived for 5 months. These studies have proved that the application of polymer fibers in artificial valves has good application prospects.
[0005] The prior art discloses a medical implant component of a composite bio-textile, which comprises a polyolefin fiber braided membrane and a polyurethane coating. The polyurethane is bonded to the surface of a polyolefin fiber sheet by hot pressing or an adhesive. Since the surface braiding structure of the fiber sheet is porous and loose, the polyurethane cannot be completely coated on the surface of the polyolefin fiber, so that there are holes between the polyurethane layer and the fiber layer, causing the bonding force to be greatly weakened. If applied to an artificial valve, the surface polyurethane is at risk of falling off, which may affect its durability. In addition, the melting point of polyurethane is generally above 170°C, and a certain temperature is required during hot pressing to melt and bond the polyurethane. However, the melting point of polyolefin is only about 110°C, and its fiber heat bearing capacity is very low, and the strength will drop sharply at high temperatures. Therefore, the hot pressing process is likely to damage the polyolefin fiber, making the performance of the composite material significantly lower than theoretical expectations. However, due to the dense and porous structure of the braid, the high viscosity of the polyurethane solution makes it impossible to completely penetrate the pores in the dip coating process, resulting in hole defects on the surface of the composite material, which may not meet the material performance requirements of the occluding device or artificial valve.
[0006] The prior art discloses a fabric for medical devices, which is prepared by knitting or weaving one or more fiber materials such as polyethylene, polypropylene, polytetrafluoroethylene, etc. In this scheme, when the fiber is coated by spraying, a solution with a higher concentration cannot be used, and only a low-concentration diluted solution can be used. After spraying, the flow of the solution is very easy to gather on the fiber surface to form liquid droplets, resulting in uneven fiber thickness, affecting the subsequent weaving structure and morphology. When the impregnation process is used, due to the poor fluidity of the solution with a higher viscosity, and the fiber is composited by multiple strands of yarn, it is difficult for the pores between the yarns in the fiber to be completely filled with the solution, affecting the strength and structural stability of the composite fiber.
[0007] The prior art discloses a textile-based reinforced composite leaflet. When the polymer film layer is combined with the fabric layer by heat treatment or ultrasonic welding, some types of fibers, such as polyethylene and polypropylene fibers, are not resistant to high temperatures and are easily damaged and lose their original performance. In addition, since the fabric layer uses a variety of different fiber materials, their surface properties are not the same. Using the same composite process and polymer film layer material, the two layers of materials cannot be uniformly and firmly combined. The surface of the fiber material with relatively weak bonding strength will form a weak point of bonding, and the film layer is easily peeled off from the fiber surface, and then the composite material is broken and fails.
[0008] In summary, in the prior art, when preparing composite membrane materials for medical implants such as artificial heart valves and artificial blood vessels, most of them are to weave fibers into fabrics, and then dip-coat the woven fabric as a whole to form a coating. However, this method will cause the interior of the fabric to be unable to penetrate the dipping liquid, and thus the coating cannot be formed, resulting in an unstable weaving structure and causing a significant change in the morphology of the device material, which has an adverse effect on the performance of the device.
[0009] Based on the defects existing in the current preparation methods of medical implants, it is necessary to improve them. Summary of the Invention
[0010] In view of this, the present invention proposes a preparation method of medical implants to solve or at least partially solve the defects existing in the prior art.
[0011] The present invention provides a preparation method of medical implants, comprising the following steps:
[0012] Perform plasma treatment on the polymer fibers;
[0013] Place the plasma-treated polymer fibers in a polymer elastomer solution for dip coating, drying, and then re-shaped into a fabric to obtain a medical implant;
[0014] Among them, the process parameters controlled by the plasma treatment are: the plasma treatment power is 50 - 600 W, the plasma treatment time is 4 - 500 s, the plasma treatment gas includes at least one of air, argon, and oxygen, and the plasma treatment gas flow rate is 0.1 - 10 L / min.
[0015] Preferably, in the preparation method of the medical implant, the polymer fibers include at least one of monofilament polymer fibers, multifilament polymer fibers, and composite fibers composed of at least two different polymer fibers;
[0016] The material of the polymer fibers includes any one of ultra-high molecular weight polyethylene, polypropylene, polyacrylonitrile, polyethylene terephthalate, polyamide, and polytetrafluoroethylene;
[0017] And / or, the fineness of the polymer fibers is 2 - 50 dtex.
[0018] The material of the polymer fibers includes at least one of ultra-high molecular weight polyethylene, polypropylene, polyacrylonitrile, polyethylene terephthalate, polyamide, polytetrafluoroethylene, ultra-high molecular weight polyethylene multifilament, polypropylene multifilament, polyacrylonitrile multifilament, polyethylene terephthalate multifilament, polyamide multifilament, and polytetrafluoroethylene multifilament;
[0019] And / or, the fineness of the polymer fibers is 2 - 50 dtex.
[0020] Preferably, in the preparation method of the medical implant, the polymer elastomer solution includes a polymer elastomer and an organic solvent;
[0021] The polymer elastomer includes a polyurethane-based elastomer and / or a styrene-based elastomer;
[0022] The organic solvent includes at least one of tetrahydrofuran, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide;
[0023] The mass concentration of the polymer elastomer solution is 2-20%, and the dipping time is 1-500 s.
[0024] Preferably, in the method for preparing the medical implant, when the polymer fiber after plasma treatment is dipped in the polymer elastomer solution, ultrasonic treatment is further included for the polymer elastomer solution, and the ultrasonic power is 100-500 W.
[0025] Preferably, in the method for preparing the medical implant, the medical implant includes an artificial heart valve or an artificial blood vessel.
[0026] Preferably, in the method for preparing the medical implant, a medical implant preparation device is further included, and the medical implant is prepared by using the medical implant preparation device;
[0027] The medical implant preparation device includes:
[0028] A feeding unit for providing and transporting the polymer fiber;
[0029] A plasma treatment unit located on one side of the polymer fiber, and the plasma treatment unit is used for plasma-treating the polymer fiber;
[0030] A dipping unit including a dipping container storing the polymer elastomer solution, and the polymer fiber after plasma treatment is dipped in the polymer elastomer solution;
[0031] A drying unit for drying the dipped polymer fiber.
[0032] Preferably, in the method for preparing the medical implant, the feeding unit includes at least a pair of feeding rollers, and the polymer fiber is transported through the feeding rollers into the dipping container for dipping;
[0033] The plasma treatment unit includes a plurality of plasma blowers located on one side of the polymer fiber and performing plasma treatment on the polymer fiber;
[0034] The dipping unit further includes: a closed container, and the dipping container is arranged in the closed container;
[0035] An immersion roller is further arranged in the dipping container, the polymer fiber passes through the feeding rollers and then penetrates into the closed container and passes through the immersion roller, and then passes through the closed container and enters the drying unit.
[0036] Preferably, the method for preparing the medical implant further includes a material receiving unit, which includes a material receiving roller and a material receiving motor. The rotating shaft of the material receiving motor is connected to the material receiving roller to drive the material receiving roller to rotate;
[0037] The dried polymer fibers are wound onto the material receiving roller and collected;
[0038] The drying unit includes a drying chamber, in which a plurality of drying rollers are provided. After passing through the dip coating roller, the polymer fibers enter the drying chamber, pass through the plurality of drying rollers, and are wound onto the material receiving roller.
[0039] Preferably, the method for preparing the medical implant further includes a recycling unit, which includes:
[0040] A condenser, one end of which is communicated with the drying chamber through a first pipeline and the other end of which is communicated with a sealed container through a second pipeline;
[0041] A solution absorber, which is communicated with the condenser and is used for absorbing the volatilized solvent;
[0042] An adsorber, which is communicated with the solution absorber and is filled with an adsorption material for adsorbing gas;
[0043] A first one-way valve is provided in the first pipeline, and the first one-way valve is used for discharging the volatilized solvent into the condenser;
[0044] A second one-way valve is provided in the second pipeline, and the second one-way valve is used for discharging the condensed solvent into the sealed container.
[0045] Preferably, for the method for preparing the medical implant, a first blower is provided on one side of the sealed container to blow air into the sealed container;
[0046] A first liquid receiving tank is further provided in the sealed container outside the dip coating container, and the first liquid receiving tank is used for receiving the solution on the polymer fibers after dip coating;
[0047] A first visualization window is provided on the sealed container;
[0048] A first hatch is provided on the sealed container;
[0049] A second blower is provided on one side of the drying chamber;
[0050] A second visualization window is provided on the drying chamber;
[0051] A second hatch is provided on the drying chamber;
[0052] During dip coating, the wind speed in the sealed container is controlled to be 2-10 m / s and the humidity is less than 10%;
[0053] During drying, control the temperature in the drying chamber to be 60 - 80°C, the wind speed to be 2 - 10 m / s, the humidity to be less than 5%, and the drying time to be greater than 120 s;
[0054] During material collection, control the linear speed of the material collection roller to be 10 - 500 mm / s.
[0055] The preparation method of the medical implant of the present invention has the following technical effects compared with the prior art:
[0056] 1. In the preparation method of the medical implant of the present invention, the polymer fiber is subjected to plasma treatment and then dip-coated with a polymer elastomer solution. After the surface of the polymer fiber is bombarded and treated by plasma gas, the specific surface area of the fiber surface is increased and active groups are introduced, improving the surface energy of the polymer fiber, which is beneficial to enhancing the bonding force between the polymer fiber and the polymer elastomer coating in the subsequent steps; after the polymer fiber is first subjected to the plasma treatment unit and then wrapped with the polymer elastomer coating, a composite fiber material is formed; on the one hand, after the polymer fiber is wrapped with the polymer elastomer, during the subsequent forming process into a sheet fabric, static electricity will not be generated due to the friction between the yarn and the machine, so that the yarns are dispersed, and thus there is no need to perform antistatic treatment on the fiber, which is convenient for subsequent processing; on the other hand, the coating of the surface polymer elastomer is tightly combined with the polymer fiber, which can further improve the strength of the fiber and reduce the risk of fracture when forming into a sheet fabric, and the distribution of defect points is significantly reduced; by first subjecting the polymer fiber to plasma treatment, then dip-coating with the polymer elastomer solution, and finally performing subsequent forming processing, the present invention can ensure that the coating completely penetrates and fills the surface of the polymer fiber in the formed fabric and the internal pores between adjacent polymer fibers; it solves the defect that in the prior art, when the fiber is first woven into a fabric and then the woven fabric is subjected to overall dip-coating, no coating can be formed inside, thereby reducing the mutual slippage between fibers during the application of the device and avoiding the adverse impact on the device performance caused by the large change in the morphology of the device material due to the unstable braided structure;
[0057] 2. In the preparation method of the medical implant of the present invention, ultrasonic treatment is performed on the polymer elastomer solution during dip-coating. The ultrasonic oscillation keeps the solution concentration uniform and can completely cover and penetrate into the fiber surface and internal pores;
[0058] 3. The medical implant of the present invention is prepared by using a medical implant preparation device, which includes a feeding unit, a plasma treatment unit, a dip-coating unit, a drying unit, and a recovery unit; by using this device, the full recovery and utilization of the solvent in the polymer elastomer solution can be realized, and zero emission of polluting gases occurs during the whole preparation process, reducing the production and hazardous waste treatment costs and improving the safety of the preparation process. Description of the Drawings
[0059] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.
[0060] Figure 1 It is a schematic structural diagram of a medical implant preparation device in one embodiment of the present invention;
[0061] Figures 2 - 3 It is an electron scanning electron microscope image of PET fibers with a polyurethane ( 80A) coating prepared in Example 1 of the present invention at different magnifications;
[0062] Figures 4 - 5 It is an electron scanning electron microscope image of PET (polyethylene terephthalate) fibers in Comparative Example 1 at different magnifications;
[0063] Figures 6 - 7 It is an electron scanning electron microscope image of UHMWPE fibers with a styrene-isoprene-styrene ( D1164) coating prepared in Example 2 of the present invention at different magnifications;
[0064] Figures 8 - 9 It is an electron scanning electron microscope image of UHMWPE fibers with a styrene-isoprene-styrene ( D1164) coating prepared in Comparative Example 2 at different magnifications. Detailed Embodiments
[0065] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Generally, the components of the embodiments of the present invention described and illustrated in the drawings here can be arranged and designed in various different configurations.
[0066] Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed present invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of the present invention.
[0067] It should be noted that like reference numerals and letters refer to like items in the following figures; thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
[0068] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by terms such as "upper" is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present invention is usually placed during use, or the orientation or positional relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the present invention.
[0069] In addition, terms such as "first" and "second" are only used for distinguishing descriptions and should not be construed as indicating or implying relative importance.
[0070] In addition, in the description of the present application, the term "comprising" means "including but not limited to". The various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity and should not be construed as a rigid limitation on the scope of the present invention; therefore, it should be considered that the description of the said range has specifically disclosed all possible sub-ranges and individual values within the range. For example, it should be considered that the description of the range from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers within the range, such as 1, 2, 3, 4, 5, and 6, and this applies regardless of the range. In addition, whenever a numerical range is indicated herein, it means including any cited number (fraction or integer) within the indicated range.
[0071] Next, in conjunction with the embodiments of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present invention.
[0072] The embodiments of the present invention provide a method for preparing a medical implant, comprising the following steps:
[0073] S1. Performing plasma treatment on polymer fibers;
[0074] S2. Placing the polymer fibers after plasma treatment in a polymer elastomer solution for dip coating, drying, and then shaping into a fabric to obtain a medical implant;
[0075] Among them, the process parameters controlled by plasma treatment are as follows: the plasma treatment power is 50 - 600 W, the plasma treatment time is 4 - 500 s, the plasma treatment gas includes at least one of air, argon, and oxygen, and the plasma treatment gas flow rate is 0.1 - 10 L / min.
[0076] It should be noted that in the preparation method of the medical implant of the present invention, after the polymer fiber is subjected to plasma treatment, it is placed in a polymer elastomer solution for dip coating, and kept immersed for a certain period of time to ensure that the coating completely penetrates and fills the surface and internal pores of the fiber; the dip-coated polymer fiber is dried to form a polymer elastomer coating on the fiber surface, and then undergoes re-forming processing to obtain a medical implant (including but not limited to artificial heart valves, artificial blood vessels, etc.). In the preparation method of the medical implant of the present invention, after the polymer fiber is subjected to plasma treatment, it is dip-coated with a polymer elastomer solution. After the fiber surface is bombarded by plasma gas, the specific surface area of the fiber surface is increased and active groups are introduced, which improves the surface energy of the polymer fiber and is conducive to enhancing the bonding force between the polymer fiber and the polymer elastomer coating in the subsequent steps; after the polymer fiber is first subjected to a plasma treatment unit, it is then wrapped with a polymer elastomer coating to form a composite fiber material; on the one hand, after the polymer fiber is wrapped with a polymer elastomer, it will not generate static electricity due to the friction between the yarn and the machine during the subsequent forming into a sheet fabric, so that the yarns are dispersed, and thus there is no need to perform antistatic treatment on the fiber, which is convenient for subsequent processing; generally, the common antistatic treatment method is to add an antistatic agent on the fiber surface, which will have a certain impact on the biocompatibility of the finally processed material; while the wrapping of the polymer elastomer with excellent biocompatibility itself will also improve the biocompatibility of the final composite material; on the other hand, the coating of the surface polymer elastomer is tightly combined with the polymer fiber, which can further improve the strength of the fiber and reduce the risk of fracture when forming into a sheet fabric, and the distribution of defect points is significantly reduced.
[0077] By first subjecting the polymer fiber to plasma treatment, then dip-coating with a polymer elastomer solution, and finally performing subsequent forming processing, the present invention can ensure that the coating completely penetrates and fills the surface of the polymer fiber in the formed fabric and the internal pores between adjacent polymer fibers; it solves the defect in the prior art that when the fiber is first woven into a fabric and then the woven fabric is subjected to overall dip coating, no coating can be formed inside, thereby reducing the mutual slippage between the fibers during the application of the device and avoiding the adverse impact on the device performance caused by the large change in the shape of the device material due to the unstable braided structure.
[0078] In some embodiments, the polymer fiber includes at least one of a monofilament polymer fiber, a multifilament polymer fiber, and a composite fiber composed of at least two different polymer fibers.
[0079] Specifically, the monofilament polymer fiber includes any one of ultra-high molecular weight polyethylene fiber, polypropylene fiber, polyacrylonitrile fiber, polyethylene terephthalate fiber, polyamide fiber, and polytetrafluoroethylene fiber.
[0080] Specifically, the multifilament polymer fiber includes any one of ultra-high molecular weight polyethylene multifilament fiber, polypropylene multifilament fiber, polyacrylonitrile multifilament fiber, polyethylene terephthalate multifilament fiber, polyamide multifilament fiber, and polytetrafluoroethylene multifilament fiber.
[0081] Specifically, the polymer multifilament fibers such as ultra-high molecular weight polyethylene multifilament fiber, polypropylene multifilament fiber, and polyacrylonitrile multifilament fiber in the above embodiments refer to continuous filaments composed of dozens to hundreds of single polymer fibers.
[0082] In some embodiments, the polymer fiber is a composite fiber woven from at least two different polymer fibers. Specifically, the materials of the polymer fiber include any one of ultra-high molecular weight polyethylene, polypropylene, polyacrylonitrile, polyethylene terephthalate, polyamide, and polytetrafluoroethylene.
[0083] In some embodiments, if the polymer fiber is a composite fiber composed of at least two polymer fiber materials, after the polymer fiber is treated by plasma and then dip-coated with a polymer elastomer solution, different polymer elastomer coatings can be coated according to the surface properties of different polymer fiber materials, which can significantly improve the adhesion between the coating and the polymer fiber, and avoid the formation of weak points on the surface of a certain fiber material due to the use of the same coating material for different polymer fibers, thereby causing the coating on the composite fiber to fall off. In addition, for the pre-coated composite fiber, during the subsequent process of forming it into a fabric, the friction at the overlapping parts of the fibers in different directions can be increased, the deformation of the material structure after forming can be reduced, and it is convenient for subsequent processing of the formed material.
[0084] In some embodiments, the fineness of the polymer fiber is 2 to 50 dtex. Particularly, the fiber thickness is preferably selected from 2 to 10 dtex.
[0085] In some embodiments, the polymer elastomer solution is a solution with good biocompatibility, including but not limited to polyurethane elastomer solution and styrene elastomer solution; specifically, the polymer elastomer solution includes a polymer elastomer and an organic solvent; the polymer elastomer includes polyurethane elastomer and / or styrene elastomer; the organic solvent includes at least one of tetrahydrofuran, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide.
[0086] In some embodiments, the polyurethane elastomers include, but are not limited to, Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, Pursil, etc.; the styrenic elastomers include, but are not limited to, styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), styrene-ethylene / butene-styrene (SEBS), etc.
[0087] In some embodiments, the mass concentration of the polymer elastomer solution is 2-20%, and the dip-coating time is 1-500 s.
[0088] In some embodiments, when the plasma-treated polymer fibers are dip-coated in the polymer elastomer solution, it further includes ultrasonic treatment of the polymer elastomer solution, and the ultrasonic power is 100-500 W.
[0089] During dip-coating, the polymer elastomer solution is ultrasonically treated with an ultrasonic power of 100-500 W. The ultrasonic vibration keeps the solution concentration uniform and can completely cover and penetrate into the fiber surface and internal pores.
[0090] In some embodiments, the medical implants include, but are not limited to, artificial heart valves, artificial blood vessels, etc.
[0091] In some embodiments, as Figure 1 shown, it further includes a medical implant preparation device for preparing medical implants using the medical implant preparation device;
[0092] The medical implant preparation device includes:
[0093] A feeding unit 1 for providing and conveying the polymer fibers 10;
[0094] A plasma treatment unit 2 located on one side of the polymer fibers 10, and the plasma treatment unit 2 is used for plasma-treating the polymer fibers 10;
[0095] A dip-coating unit 3 including a dip-coating container 31 storing the polymer elastomer solution, and the plasma-treated fibers enter the polymer elastomer solution for dip-coating;
[0096] A drying unit 4 for drying the dip-coated polymer fibers 10.
[0097] In the above embodiments, a medical implant preparation device is used to prepare medical implants. Specifically, the medical implant preparation device includes a feeding unit 1, a plasma treatment unit 2, a dip coating unit 3, and a drying unit 4. The feeding unit 1 is used to provide a roll of polymer fibers 10 and convey them. The feeding unit 1 conveys the polymer fibers 10 to the plasma treatment unit 2, and the plasma treatment unit 2 performs plasma treatment on the polymer fibers 10. The polymer fibers 10 after being treated by the plasma treatment unit 2 are conveyed into the dip coating container 31 of the dip coating unit 3 and immersed in the polymer elastomer solution for a certain period of time to ensure that the coating completely wraps the surface of the polymer fibers 10, so that after being formed into a fabric subsequently, the coating completely penetrates and fills the internal pores between the surfaces of the polymer fibers in the formed fabric and adjacent polymer fibers. The dip-coated polymer fibers 10 are conveyed to the drying unit 4 to dry the dip-coated polymer fibers 10 to form a polymer elastomer coating on the surface of the polymer fibers.
[0098] In some embodiments, the feeding unit 1 includes at least a pair of feeding rollers 11, and the polymer fibers are conveyed through the feeding rollers 11 into the dip coating container 31 for dip coating.
[0099] Specifically, the feeding unit 1 includes a pair of feeding rollers 11. The two feeding rollers 11 are arranged at a relative interval. The plasma treatment unit 2 is located between the two feeding rollers 11. The driving mechanism is connected to the feeding rollers 11 to drive the feeding rollers 11 to rotate. The fibers sequentially bypass the two feeding rollers 11, and the feeding rollers 11 rotate to drive the fibers to move for feeding.
[0100] In some embodiments, the plasma treatment unit 2 includes a plurality of plasma blowers 21. The plasma blowers 21 are located between the two feeding rollers 11. The plasma blowers 21 are located on one side of the polymer fibers 10 and perform plasma treatment on the polymer fibers 10. Specifically, the plasma treatment unit 2 includes two plasma blowers 21. The plasma blowers 21 are distributed on both sides of the polymer fibers 10 and are arranged face to face and staggered by 180° on both sides of the polymer fibers, so that the entire surface of the polymer fibers can be bombarded and treated by the plasma gas, increasing the specific surface area of the polymer fiber surface and introducing active groups, and improving the surface energy of the polymer fibers.
[0101] In some embodiments, the dip coating unit 3 further includes: a closed container 32, and the dip coating container 31 is arranged in the closed container 32;
[0102] The dip coating container 31 is also provided with a dip coating roller 33. The polymer fibers pass through the feeding rollers 11 and then penetrate into the closed container 32 and pass through the dip coating roller 33, and then pass through the closed container 32 and enter the drying unit.
[0103] Specifically, in the above embodiments, the dip coating container 31 is disposed inside the closed container 32. An immersion roller 33 is provided inside the dip coating container 31. The immersion roller 33 is immersed in the polymer elastomer solution. The polymer fibers that have undergone plasma treatment enter the closed container 32, then bypass the immersion roller 33, pass through the closed container 32 and enter the drying unit, that is, the polymer fibers are dip-coated under the drive of the immersion roller 33.
[0104] In some embodiments, a material receiving unit 5 is further included. The material receiving unit includes a material receiving roller 51 and a material receiving motor. The rotating shaft of the material receiving motor is connected to the material receiving roller 51 to drive the material receiving roller 51 to rotate.
[0105] The dried fibers are wound onto the material receiving roller 51 and are received.
[0106] In some embodiments, the drying unit 4 includes a drying chamber 41. A plurality of drying rollers 42 are provided inside the drying chamber 41. The polymer fibers enter the drying chamber 41 after passing through the immersion roller 33, sequentially pass through the plurality of drying rollers 42, and are wound onto the material receiving roller 51.
[0107] Specifically, in the above embodiments, a plurality of drying rollers 42 are arranged vertically and staggeredly inside the drying chamber 41. The polymer fibers enter the drying chamber 41 after passing through the immersion roller 33, sequentially pass through the plurality of drying rollers 42, pass out of the drying chamber 41, and are wound onto the material receiving roller 51. The material receiving is realized by the rotation of the material receiving roller 51. Specifically, the power mechanism is connected to the material receiving roller 51 to drive the material receiving roller 51 to rotate. Specifically, the power mechanism is a material receiving motor. The rotating shaft of the material receiving motor is connected to the material receiving roller 51 to drive the material receiving roller 51 to rotate. Among them, the material receiving motor controls the moving speed of the polymer fibers, controls the plasma treatment time, dip coating time, and drying time of the polymer fibers. The material receiving roller 51 receives the polymer fibers after coating is completed. Finally, the wound polymer fibers after coating are used for subsequent weaving processes.
[0108] Specifically, the material of the drying roller 42 is PEEK (polyether ether ketone) or PE (polyethylene).
[0109] Specifically, in some embodiments, the wound fibers sequentially pass through the feeding roller 11, enter the closed container 32, bypass the immersion roller 33, pass through the closed container 32 and enter the drying chamber 41, sequentially pass through the plurality of drying rollers 42, pass out of the drying chamber 41, and are wound onto the material receiving roller 51 for material receiving, using the material receiving motor as the power source for the movement of the fibers.
[0110] In some embodiments, a recycling unit 6 is further included. The recycling unit 6 includes:
[0111] A condenser 61, one end of which is communicated with the drying chamber 41 through a first pipeline 62 and the other end is communicated with the closed container 32 through a second pipeline 63;
[0112] A solution absorber 64, which is connected to the condenser 61, and the solution absorber 64 is used to absorb the volatilized solvent;
[0113] An adsorber 65, which is connected to the solution absorber 64, and the adsorber 65 is filled with an adsorbent material to adsorb gases.
[0114] In the above embodiment, during the drying process of the dip-coated polymer fibers in the drying chamber 41, the solvent in the surface and internal pores of the polymer fibers with the polymer elastomer coating solution volatilizes rapidly in a clean hot air environment, and the polymer elastomer coating cures and wraps the fibers; at the same time, during the drying process, the solvent of the polymer elastomer coating solution volatilizes, and the volatile solvent enters the condenser through the first pipeline 62 for condensation; the solvent condensed by the condenser 61 is recovered into the closed container 32 through the second pipeline 63; an absorption solution, such as an alcohol solution, is provided in the solution absorber 64; the adsorber 65 is filled with an adsorbent material, such as activated carbon. After other volatile gas impurities and non-volatile particulate impurities in the polymer elastomer coating solution are absorbed by the solution absorber 64 and adsorbed by the adsorber 65, only pure air is finally discharged, and zero emission of polluting gases is achieved throughout the process.
[0115] In some embodiments, a first one-way valve 66 is provided in the first pipeline 62, and the first one-way valve 66 is used to discharge the volatilized solvent into the condenser 61;
[0116] A second one-way valve 67 is provided in the second pipeline 63, and the second one-way valve 67 is used to discharge the condensed solvent into the closed container 32.
[0117] Specifically, in the above embodiment, both the first one-way valve 66 and the second one-way valve 67 are one-way valves. The first one-way valve 66 only allows the volatilized solvent in the drying chamber 41 to be discharged into the condenser 61; the second one-way valve 67 only allows the condensed solvent to be discharged into the closed container 32.
[0118] Specifically, in some embodiments, the dip-coating container 31 is located directly below the second pipeline 63, and the solvent condensed by the condenser 61 is recovered into the dip-coating container 31 through the second pipeline 63.
[0119] In some embodiments, a first fan 34 is provided on one side of the closed container 32 to blow air into the sealed container 32; specifically, the first fan 34 is a fan with a filtering function, and the first fan 34 ensures that the environment in the entire sealed container 32 meets the standards of a Class 10,000 clean room, and the high-speed flowing air can promote the rapid volatilization of the solvent on the surface of the dip-coated fibers. And a valve is provided between the first fan 34 and the sealed container 32 to control the opening and closing of the first fan 34 through the valve.
[0120] In some embodiments, an ultrasonic generator is further provided in the dip coating container 31. The polymer elastomer solution in the dip coating container 31 can be ultrasonically oscillated to keep the solution concentration uniform. After the fiber is immersed, it will be impregnated in the solution for a certain period of time to ensure that the coating completely penetrates and fills the surface and internal pores of the fiber.
[0121] In some embodiments, a first liquid receiving tank is provided outside the dip coating container 31 in the sealed container 32. The first liquid receiving tank is used to receive the solution on the fiber after dip coating. Specifically, the first liquid receiving tank can receive the polymer elastomer solution dripping from the fiber during movement after dip coating, as well as the solvent condensed by the condenser, so as to recycle the polymer elastomer solution. Flowing the condensed solvent back to the first liquid receiving tank not only avoids environmental pollution and harm to the human body caused by organic vapors, but also can reuse the solvent to reduce costs; at the same time, a part of the recycled solvent dripping into the dip coating container 31 can compensate for the change in the concentration of the coating solution caused by solvent volatilization, ensuring the stability before and after the process.
[0122] In some embodiments, a first visualization window is provided on the sealed container 32 to observe the internal situation of the sealed container; the first visualization window is a glass window. Specifically, the internal situation of the fiber dip coating can be observed through the first visualization window.
[0123] In some embodiments, a first hatch is provided on the sealed container 32 to open or close the sealed container 32; setting the first hatch facilitates winding the fiber.
[0124] In some embodiments, a second blower 43 is provided on one side of the drying chamber 41 to blow air into the drying chamber 41; specifically, the second blower 43 is a blower with filtering and heating functions. The second blower 43 can send dry hot air into the drying chamber 41 to make the fiber composite material with a coating volatilize the solvent faster, and at the same time ensure that the environment in the entire drying chamber 41 meets the standards of a Class 10,000 clean room. And a valve is provided between the second blower 43 and the drying chamber 41 to control the air flow rate. In some embodiments, a temperature and humidity sensor is further provided in the drying chamber 41. The temperature and humidity sensor is used to monitor the temperature and humidity in the drying chamber 41 to prevent the low temperature from affecting the curing rate of the fiber surface coating, and prevent the excessive humidity from causing the coating to adsorb moisture, avoiding abnormal temperature and humidity from affecting the film-forming performance and process stability of the fiber surface coating.
[0125] In some embodiments, the drying roller 42 is detachably arranged in the drying chamber 41. The detachable drying roller 42 can fix the path of the polymer fiber in the drying chamber 41. At a certain winding rate, the drying time of the polymer fiber is fixed, and it can be conveniently disassembled during cleaning.
[0126] In some embodiments, a second liquid receiving tank is further provided in the drying chamber 41. The second liquid receiving tank is used to receive the solvent volatilized during the drying process.
[0127] In some embodiments, a second visualization window is provided on the drying chamber 41 to observe the internal situation of the drying chamber; the second visualization window is a glass window, specifically, to observe the drying condition of the fibers in the drying chamber.
[0128] In some embodiments, a second hatch is provided on the drying chamber 41 for opening or closing the drying chamber 41. The provision of the second hatch facilitates the winding of the fibers.
[0129] Specifically, in some embodiments, a fiber pipeline 36 is connected between the sealed container 31 and the drying chamber 41, and a connecting roller 35 is further provided on one side of the sealed container where it is located adjacent to the dipping container 31. After the fiber bypasses the dipping roller 33, it then bypasses the connecting roller 35, enters the drying chamber 41 through the fiber pipeline 36, and sequentially bypasses a plurality of drying rollers 42; the polymer elastomer solution is swept by hot air in the sealed container and the drying chamber to form organic vapor. The organic vapor in the sealed container flows with the air current to the fiber pipeline 36 and enters the drying chamber 41, and together with the organic vapor formed in the drying chamber 41, it flows through the first one-way valve 66 to the condenser. The condenser cools and liquefies the organic vapor through circulating water cooling, and under the action of gravity, it flows back to the dipping container 31 and the first liquid receiving tank in the sealed container 31 through the second one-way valve 67. In this way, the concentration of the polymer elastomer solution in the dipping container 31 can be maintained in a dynamically balanced state; the solvent in the first liquid receiving tank can be completely recycled and reused, avoiding pollution and improving economic benefits; the condenser is controlled at a temperature of 1 - 4 °C through circulating water cooling. The remaining other volatile gas impurities and non-volatile particulate impurities are absorbed by the solution absorber 64 and adsorbed by the adsorber 65, and finally only pure air is discharged, achieving zero emission of polluting gases throughout the process.
[0130] Specifically, in some embodiments, the polymer fiber is first subjected to plasma treatment. The effective treatment length of the plasma blower (the length refers to the horizontal length in the figure) is about 2 - 5 m, and the converted treatment time is 4 - 500 s.
[0131] In some embodiments, the plasma treatment gas includes at least one of air, argon, and oxygen. Preferably, the plasma treatment gas includes a mixture of argon and oxygen, and the volume content of argon in the mixture is 10% - 90%.
[0132] In some embodiments, after the polymer fiber is subjected to plasma treatment, it enters the sealed container for dipping in the polymer elastomer solution. The air inside the sealed container is normal-temperature flowing air, with a wind speed of 2 - 10 m / s and a humidity of less than 10%.
[0133] In some embodiments, the effective length of the dip-coating container is 0.5 - 5 m, and the dipping time of the polymer fiber in the polymer elastomer solution can be controlled to be 1 - 500 s. During dipping, the polymer elastomer solution is ultrasonically treated with an ultrasonic power of 100 - 500 W. The ultrasonic vibration keeps the concentration of the polymer elastomer solution uniform and enables the polymer elastomer solution to completely cover and uniformly penetrate the surface of the polymer fiber. Around the dip-coating container, a first liquid receiving tank is distributed, which can completely recover the solvent volatilized from the coating on the fiber surface.
[0134] In some embodiments, after dipping, the polymer fiber enters a drying chamber for drying. The coating solution on the surface of the polymer fiber quickly volatilizes the solvent in a clean hot air environment, and the coating cures to wrap the fiber. The temperature of the hot air environment in the drying chamber is 60 - 80 °C, the wind speed is 2 - 10 m / s, and the humidity is less than 5%. The path length of the fiber on the drying roller 42 in the drying chamber is not less than 60 m. Therefore, the drying time of the fiber can be guaranteed to be greater than 120 s, so that the coating on the fiber surface is fully cured.
[0135] In some embodiments, after the fiber is dried, it enters the winding unit. Specifically, the polymer fiber is wound around a winding roller, and the linear speed of the winding motor is 10 - 500 mm / s. Then, the linear speed of the winding roller is controlled to be 10 - 500 mm / s. By controlling the uniform winding of the fiber, a wound polymer fiber with a coating is finally formed. This polymer fiber with a coating can be used for subsequent forming processes to form polymer composite membranes for medical fields such as artificial heart valves and artificial blood vessels.
[0136] The following further illustrates the preparation method of the medical implant of the present invention with specific embodiments. This part further illustrates the content of the present invention in combination with specific embodiments, but should not be construed as a limitation to the present invention. Unless otherwise specified, the technical means used in the embodiments are conventional means well-known to those skilled in the art. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the art.
[0137] Example 1
[0138] This example provides a preparation method of a medical implant. The medical implant is specifically an artificial heart valve, and the medical implant is prepared using the medical implant preparation device as shown in Figure 1 and specifically includes the following steps:
[0139] S1. Provide a raw material of wound PET (polyethylene terephthalate) fiber (purchased from ICF Mercantile, LLC, United States), and the fineness of the PET fiber is 20 dtex multifilament;
[0140] S2. The PET fibers are successively wound around the feeding rollers. Two plasma blowers are arranged in parallel on both sides of the PET fibers and are relatively staggered. The effective treatment time of the two plasma blowers is 3 min;
[0141] The PET fibers are subjected to plasma treatment by the plasma blowers. The controlled process parameters are: power is 300 W, the gas is a mixed gas of argon and oxygen (the volume ratio of argon to oxygen is 3:7), and the gas flow rate is set to 1 L / min;
[0142] S3. After the PET fibers are subjected to plasma treatment, they enter a closed container for dip coating with a polymer elastomer solution. The wind speed in the closed container is 8 m / s and the humidity is 6%;
[0143] The polymer elastomer solution includes a polymer elastomer and an organic solvent; the polymer elastomer is polyurethane ( 80A), and the organic solvent is N,N-dimethylacetamide;
[0144] The mass concentration of the polymer elastomer solution is 10%;
[0145] The effective dip coating time of the dip coating treatment is 4 min. During dip coating, the polymer elastomer solution is simultaneously subjected to ultrasonic treatment, and the ultrasonic power is 300 W;
[0146] S4. After the PET fibers are dip coated, they enter a drying chamber for drying; the temperature of the hot air environment in the drying chamber is 80 °C, the wind speed is 10 m / s, and the humidity is 2%; the drying time of the fibers in the drying chamber is 20 min;
[0147] S5. After the fibers are dried, they enter the winding unit. The linear speed of the winding motor is controlled to be 100 mm / s, and then the linear speed of the winding roller is controlled to be 100 mm / s;
[0148] The temperature control of the condenser in the recovery unit by circulating water cooling is at 4 °C;
[0149] S6. The wound PET fibers are formed into a fabric to obtain a medical implant.
[0150] Example 2
[0151] This example provides a preparation method of a medical implant. The medical implant is specifically an artificial heart valve and is prepared by using a medical implant preparation device as shown in Figure 1 The following steps are specifically included:
[0152] S1. Provide a roll of UHMWPE (ultra-high molecular weight polyethylene, ) fiber raw material. The fineness of the UHMWPE fiber is 20 dtex multifilament;
[0153] S2. The UHMWPE fiber is successively wound around the feeding roller. Two plasma blowers are distributed in parallel on both sides of the UHMWPE fiber and are arranged relatively staggeredly. The effective treatment time of the two plasma blowers is 5 min;
[0154] The UHMWPE fiber is subjected to plasma treatment by the plasma blower. The controlled process parameters are: power is 500 W, gas is argon, and gas flow rate is set at 3 L / min;
[0155] After the UHMWPE fiber is subjected to plasma treatment, it enters a closed container for dip coating with a polymer elastomer solution. The wind speed in the closed container is 8 m / s and the humidity is 6%;
[0156] The polymer elastomer solution includes a polymer elastomer and an organic solvent; the polymer elastomer is styrene-isoprene-styrene ( D1164), and the organic solvent is toluene;
[0157] The mass concentration of the polymer elastomer solution is 10%;
[0158] The effective dip coating time of the dip coating treatment is 4 min. During dip coating, the polymer elastomer solution is subjected to ultrasonic treatment, and the ultrasonic power is 300 W;
[0159] After the UHMWPE fiber is dip coated, it enters a drying chamber for drying; the temperature of the hot air environment in the drying chamber is 60 °C, the wind speed is 8 m / s, and the humidity is 2%; the drying time of the fiber in the drying chamber is 15 min;
[0160] After the fiber is dried, it enters the winding unit. The linear speed of the winding motor is controlled at 200 mm / s, and then the linear speed of the winding roller is controlled at 200 mm / s;
[0161] The temperature control of the condenser in the recovery unit by circulating water cooling is at 2 °C;
[0162] S6. The wound UHMWPE fiber is formed into a fabric to obtain a medical implant.
[0163] Comparative Example 1
[0164] This Comparative Example 1 provides a wound PET (polyethylene terephthalate) fiber (purchased from ICF Mercantile, LLC United States), and the fineness of the PET fiber is 20 dtex multifilament.
[0165] Comparative Example 2
[0166] This comparative example provides a preparation method of a medical implant, which is carried out as Figure 1The medical implant preparation device shown prepares medical implants, specifically including the following steps:
[0167] S1. Provide a roll of UHMWPE (ultra-high molecular weight polyethylene, ) fiber raw material, and the fineness of the UHMWPE fiber is 20 dtex multifilament;
[0168] S2. The UHMWPE fiber bypasses the feeding roller in sequence and enters a closed container for dip coating with a polymer elastomer solution. The wind speed in the closed container is 8 m / s and the humidity is 6%;
[0169] The polymer elastomer solution includes a polymer elastomer and an organic solvent; the polymer elastomer is styrene-isoprene-styrene ( D1164), and the organic solvent is toluene;
[0170] The mass concentration of the polymer elastomer solution is 10%;
[0171] The effective dip coating time for the dip coating treatment is 4 min;
[0172] S4. After dip coating, the UHMWPE fiber enters a drying chamber for drying; the temperature of the hot air environment in the drying chamber is 60 °C, the wind speed is 8 m / s, and the humidity is 2%; the drying time of the fiber in the drying chamber is 15 min;
[0173] S5. After drying, the fiber enters the winding unit, and the linear speed of the winding motor is controlled to be 200 mm / s, and then the linear speed of the winding roller is controlled to be 200 mm / s;
[0174] S6. The wound UHMWPE fiber is formed into a fabric to obtain a medical implant.
[0175] Performance test
[0176] Figures 2 - 3 Figure [ID number] is the electron scanning electron micrograph of the PET fiber with a polyurethane ( 80A) coating prepared in Example 1 (that is, a polyurethane coating can be formed on the surface of the PET fiber after drying in step S4 in Example 1).
[0177] Figures 4 - 5 Figure [ID number] is the electron scanning electron micrograph of the PET (polyethylene terephthalate) fiber in Comparative Example 1.
[0178] It can be seen from Figures 2 - 3 that the surface of the PET fiber is tightly wrapped by the polyurethane coating and is not easily dispersed, which is convenient for subsequent processing; at the same time, the polyurethane coating bonded to the surface of the PET fiber improves the fiber strength and avoids fiber breakage during subsequent processing.
[0179] Furthermore, fromFigures 2 - 3 and Figures 4 - 5 It can be seen from the comparison that after the PET fibers in Example 1 are dipped in the polymer elastomer solution and dried, a polyurethane coating can be formed on the surface of the PET fibers, and the polyurethane coating tightly wraps the PET fibers.
[0180] The tensile fracture strength of the PET fibers with a polyurethane ( 80A) coating prepared in Example 1 is 338.47 MPa, and the elongation at break is 15.1%. While the tensile fracture strength of the PET fibers in Comparative Example 1 is 272.5 MPa, and the elongation at break is 10.6%. It can be seen that the PET fibers with a polyurethane ( 80A) coating prepared in Example 1 have greatly improved fracture strength and elongation at break compared with the PET fibers in Comparative Example 1, further indicating that the polyurethane coating bonded to the surface of the PET fibers can greatly improve the strength of the fibers, thereby avoiding the fracture of the fibers during subsequent processing.
[0181] Figures 6 - 7 Fig. is the electron scanning electron micrograph of the UHMWPE fibers with a styrene-isoprene-styrene ( D1164) coating prepared in Example 2 (that is, after drying in step S4 in Example 2, a styrene-isoprene-styrene coating can be formed on the surface of the UHMWPE fibers).
[0182] From Figures 6 - 7 it can be seen that the surface of the UHMWPE fibers is tightly wrapped by the styrene-isoprene-styrene coating, not easily dispersed, and convenient for subsequent processing. At the same time, the styrene-isoprene-styrene coating bonded to the surface of the UHMWPE fibers increases the strength of the fibers and avoids the fracture of the fibers during subsequent processing.
[0183] Figures 8 - 9 Fig. is the electron scanning electron micrograph of the UHMWPE fibers with a styrene-isoprene-styrene ( D1164) coating prepared in Comparative Example 2 (that is, after drying in step S4 in Comparative Example 2, a styrene-isoprene-styrene coating can be formed on the surface of the UHMWPE fibers).
[0184] From Figures 8 - 9 it can be seen that the coating on the surface of the fibers prepared by the process of Comparative Example 2 is unevenly distributed, and the coating cannot penetrate evenly on the surface of the fibers.
[0185] The styrene-isoprene-styrene ( The tensile fracture strength of the UHMWPE fiber with the D1164) coating is 4.06 GPa, and the elongation at break is 4.0%. While for the UHMWPE fiber with the styrene-isoprene-styrene (
[0186] Further, it can be seen from the comparison between Example 2 and Comparative Example 2 that pre-treating the polymer fiber with plasma and performing ultrasonic treatment during dip coating in the process of preparing medical implants can make the polymer elastomer coating uniformly disperse on the surface of the polymer fiber, and further make the polymer elastomer coating uniformly penetrate on the surface of the polymer fiber, thereby improving the tensile fracture strength and elongation at break of the polymer fiber, and further avoiding the fracture of the fiber during subsequent processing.
[0187] The above is only the preferred embodiment of the present invention and is not intended to limit the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims
1. A method for preparing a medical implant, characterized in that, It includes the following steps: Perform plasma treatment on the polymer fiber; Place the plasma-treated polymer fiber in a polymer elastomer solution for dip coating, drying, and then re-form it into a fabric to obtain a medical implant; Among them, the process parameters controlled by the plasma treatment are: the plasma treatment power is 50 - 600 W, the plasma treatment time is 4 - 500 s, the plasma treatment gas includes at least one of air, argon, and oxygen, and the plasma treatment gas flow rate is 0.1 - 10 L / min.
2. The method for preparing a medical implant according to claim 1, characterized in that, The polymer fiber includes at least one of monofilament polymer fiber, multifilament polymer fiber, and composite fiber composed of at least two different polymer fibers; The material of the polymer fiber includes any one of ultra-high molecular weight polyethylene, polypropylene, polyacrylonitrile, polyethylene terephthalate, polyamide, and polytetrafluoroethylene; And / or, the fineness of the polymer fiber is 2 - 50 dtex.
3. The method for preparing a medical implant according to claim 1, characterized in that, The polymer elastomer solution includes a polymer elastomer and an organic solvent; The polymer elastomer includes a polyurethane-based elastomer and / or a styrene-based elastomer; The organic solvent includes at least one of tetrahydrofuran, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide; The mass concentration of the polymer elastomer solution is 2 - 20%, and the dip coating time is 1 - 500 s.
4. The method for preparing a medical implant according to claim 1, characterized in that, When the plasma-treated polymer fiber is placed in the polymer elastomer solution for dip coating, it also includes ultrasonic treatment of the polymer elastomer solution, and the ultrasonic power is 100 - 500 W.
5. The method for preparing a medical implant according to any one of claims 1 to 4, characterized in that, The medical implant includes an artificial heart valve or an artificial blood vessel.
6. The method for preparing a medical implant according to claim 5, characterized in that, It also includes a medical implant preparation device, and uses the medical implant preparation device to prepare a medical implant; The medical implant preparation device includes: A feeding unit for providing and conveying the polymer fiber; A plasma treatment unit located on one side of the polymer fiber, and the plasma treatment unit is used to perform plasma treatment on the polymer fiber; A dip coating unit including a dip coating container, and the dip coating container stores a polymer elastomer solution, and the plasma-treated polymer fiber is dip-coated in the polymer elastomer solution; A drying unit for drying the dip-coated polymer fiber.
7. The method for preparing a medical implant according to claim 6, characterized in that, The feeding unit includes at least a pair of feeding rollers, and the polymer fiber is conveyed through the feeding rollers into the dip coating container for dip coating; The plasma treatment unit includes a number of plasma blowers, and the plasma blowers are located on one side of the polymer fiber and perform plasma treatment on the polymer fiber; The dip coating unit further includes: a closed container, and the dip coating container is arranged in the closed container; A dip coating roller is further arranged in the dip coating container, and the polymer fiber passes through the feeding rollers and then penetrates into the closed container and passes through the dip coating roller, and then passes through the closed container and enters the drying unit.
8. The method for preparing a medical implant according to claim 7, characterized in that, It also includes a winding unit, and the winding unit includes a winding roller and a winding motor, and the rotating shaft of the winding motor is connected to the winding roller to drive the winding roller to rotate; The dried polymer fiber is wound onto the winding roller and collected; The drying unit includes a drying chamber, in which a plurality of drying rollers are provided. The polymer fibers enter the drying chamber after passing through the dip coating roller, pass through the plurality of drying rollers, and are wound onto a take-up roller.
9. The method for preparing a medical implant according to claim 8, characterized in that, It further includes a recovery unit, which includes: A condenser, one end of which is communicated with the drying chamber through a first pipeline and the other end is communicated with a closed container through a second pipeline; A solution absorber, which is communicated with the condenser and is used to absorb the volatilized solvent; An adsorber, which is communicated with the solution absorber and is filled with an adsorbent material for adsorbing gas; A first one-way valve is provided in the first pipeline, and the first one-way valve is used to discharge the volatilized solvent into the condenser; A second one-way valve is provided in the second pipeline, and the second one-way valve is used to discharge the condensed solvent into the closed container.
10. The method for preparing a medical implant according to claim 8, wherein, A first fan is provided on one side of the closed container to blow air into the closed container; A first liquid receiving tank is further provided in the closed container outside the dip coating container, and the first liquid receiving tank is used to receive the solution on the polymer fibers after dip coating; A first visualization window is provided on the closed container; A first hatch is provided on the closed container; A second fan is provided on one side of the drying chamber; A second visualization window is provided on the drying chamber; A second hatch is provided on the drying chamber; During dip coating, the wind speed in the closed container is controlled to be 2-10 m / s and the humidity is less than 10%; During drying, the temperature in the drying chamber is controlled to be 60-80 °C, the wind speed is 2-10 m / s, the humidity is less than 5%, and the drying time is greater than 120 s; During take-up, the linear speed of the take-up roller is controlled to be 10-500 mm / s.