CN113499484A - Surface hydrophilic layer modification method for implantable medical device and application - Google Patents
Surface hydrophilic layer modification method for implantable medical device and application Download PDFInfo
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Abstract
The invention discloses a surface hydrophilic layer modification method for an implantable medical device and application, and belongs to the technical field of medical devices. The invention modifies the surface of the medical appliance through the plasma hydrophilic modification, or the hydrogel prepared by the water-soluble polymer with biocompatibility and the viscous component, or the biological extract, so as to form a hydrophilic layer, thereby improving the surface lubricity of the biological medical appliance, reducing the resistance generated in the using process of the medical appliance, reducing the damage of the implanted medical appliance to tissues, reducing complications, improving the biocompatibility, and having the advantages of simple method, good lubricating effect, convenient operation, safety, environmental protection and the like. The invention also discloses a hydrophilic layer on the surface of the implantable medical device and the implantable medical device with the hydrophilic layer modification.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a surface hydrophilic layer modification method for an implanted medical instrument and application thereof.
Background
The implanted medical device is in direct contact with tissues and organs in a human body to generate mutual friction, the tissues and the organs can be damaged, discomfort is caused to a patient, and even a series of complications can be caused under severe conditions, so that the improvement of the surface lubricity of the implanted medical device is particularly important. The surface hydrophilic modification treatment is an effective method for improving the lubricating effect of the medical apparatus and reducing the friction between the medical apparatus and tissues and organs, and has important significance for promoting the application of the implanted medical apparatus.
At present, the method for hydrophilic treatment of the surface of the medical device mainly comprises the following steps: 1. the lubricity and hydrophilicity of the medical instrument are better improved by preparing the hydrogel layer on the surface of the medical instrument, but the hydrogel layer is easy to fall off after multiple times of friction due to the lack of strong connection between the hydrogel layer and the medical instrument, so that the durable use of the hydrophilic layer is influenced (CN112574460A and CN 107412883B); 2. hydrophilicity was improved to some extent by preparing an organic/inorganic hybrid composite hydrophilic layer, but the material preparation was carried out in an organic solvent, which had an effect on its biological application (CN 107158484A).
In general, the existing hydrophilic modification treatment method for medical instruments has the problems of non-lasting hydrophilic lubrication effect, poor biocompatibility, complex preparation method and the like. Therefore, the development of a novel hydrophilic layer modification material for implantable medical devices, which has a simple preparation method, a durable lubricating effect and good biocompatibility, is particularly urgent.
Disclosure of Invention
In order to solve the technical problems in the background art, the invention aims to provide a surface hydrophilic layer modification method and application for an implantable medical device. The invention improves the lubricity of the surface of the medical appliance by modifying the hydrophilic layer, reduces the resistance of the medical appliance, reduces the damage of the implanted medical appliance to tissues and organs, reduces complications and improves the biocompatibility of the medical appliance.
The invention provides a surface hydrophilic layer modification method for an implantable medical device, and in the technical scheme of the invention, the surface hydrophilic layer modification method comprises plasma hydrophilic modification, hydrogel hydrophilic modification and biological extract modification.
Specifically, the process of the hydrogel hydrophilic modification is as follows:
step 1 a: selecting water-soluble polymers with excellent biocompatibility, adding a certain amount of viscous components, uniformly mixing to prepare an aqueous solution with a certain concentration, drying to form a film, and soaking the film in a divalent or trivalent metal cation solution with a certain concentration, or changing external conditions to realize crosslinking to obtain hydrogel;
step 1 b: mixing water-soluble high polymer with excellent biocompatibility, a cross-linking agent, an initiator and a certain amount of viscous components to prepare an aqueous solution with a certain concentration, and crosslinking the aqueous solution into hydrogel through ultraviolet illumination, heating and radiation;
step 2: and (3) uniformly coating the hydrogel obtained in the step (1 a) or the step (1 b) on the surface of the medical instrument to prepare a hydrogel hydrophilic layer.
Further, the water-soluble polymer having excellent biocompatibility is selected from the group consisting of sodium alginate, chitosan, hyaluronic acid, elastin, polypeptide, gelatin, collagen, peptidoglycan, agar, starch, cellulose, carboxymethyl chitin, polyhydroxyethylmethacrylate, dextran-methacrylate gelatin, polymethacrylic acid, sodium polymethacrylate, polyacrylic acid, sodium polyacrylate, one or more of polyacrylamide, polyethylacrylic acid, polypropyleneacrylic acid, polyvinylbenzoic acid, polyisopropylacrylamide, polylysine, poly-L-glutamic acid, polyaspartic acid, polyglycine, polyitaconic acid, polyvinyl alcohol, carboxylated polyvinyl alcohol, polyoxyethylene, polyethylene glycol diacrylate, polyurethane, polyvinylpyrrolidone, polymaleic anhydride and derivatives thereof.
Further, the viscous component in step 1a and step 1b is selected from any one of polydopamine, viscous protein and medical glue, and the mass fraction of the viscous component is 0.1-20%.
Further, the concentration of the aqueous solution prepared from the water-soluble polymer and the viscous component in the step 1a is 0.1mmol/L-10 mol/L. The divalent or trivalent metal cation is selected from Ca2+、Mg2+、Ba2+、Fe2+、Zn2+、Mn2+、Fe3+、Al3+One or more of them. The total concentration of the divalent or trivalent metal cations is 0.1mmol/L to 10 mol/L.
Further, in the step 1a, the external condition is changed into temperature or pH value adjustment, and the corresponding crosslinking method is selected according to different reaction systems, wherein the temperature is changed from-20 ℃ to 100 ℃. The pH adjustment range is 1-14. It is worth mentioning that the present invention comprises a plurality of different systems for pH crosslinking, both acidic and basic, and therefore the pH range is wide. The crosslinking time is 1min-24 h.
Further, in the step 1b, the mass fraction of the cross-linking agent is 0.1-20%, the mass fraction of the initiator is 0.1-20%, and the cross-linking time is 1min-24 h.
Specifically, the hydrophilic modification process of the biological extract lubricating layer is as follows:
preparing a biological extract containing a hydrophilic lubricating substance into a viscous aqueous solution, and then coating the surface of the medical device by any one selected from spray coating, dip coating, drop coating, spin coating and bioprinting.
The biological extract containing hydrophilic lubricating substance is at least one selected from surface mucus of herba Zosterae Marinae, fish surface mucus, snail mucus, Aloe mucus, and Agaricus campestris solution.
In the technical scheme of the invention, the hydrophilic lubricating substance contained in the surface mucus of the kelp is mainly mannitol, the hydrophilic lubricating substance contained in the surface mucus of the fish is mainly mucopolysaccharide, the hydrophilic lubricating substance contained in the snail mucus is mainly allantoin, glycolic acid and ossein, and the hydrophilic lubricating substance contained in the aloe mucus is mainly mannan.
Further, the viscous water solution of the biological hydrophilic lubricating substance is 0.1mmol/L-10 mol/L.
Further, the soaking time is 1-24 h.
Specifically, the plasma hydrophilic modification is at least one selected from the group consisting of oxygen plasma, ammonia plasma, hydrogen plasma, carbon dioxide plasma, and other gas plasma.
Further, the vacuum degree is-0.1 to-0.095, the voltage is 600-800V, and the plasma surface treatment time is 1-60 min.
The plasma modification process is as follows:
wiping the surface of the medical instrument with ethanol and water, drying the medical instrument with nitrogen, placing the medical instrument in a plasma surface treatment instrument, vacuumizing, adjusting voltage and time, and generating hydrophilic groups on the surface of the medical instrument through plasma surface treatment.
Further, the hydrophilic group is selected from one or more of hydrophilic groups such as C ═ oxycarbonyl, -COOH carboxyl group, -OH hydroxyl group and the like.
In the technical scheme of the invention, the medical apparatus is an instrument, equipment, an appliance and a material which are directly used for a human body, is prepared from at least one material selected from gold, silver, platinum, palladium, copper, steel, tantalum, magnesium, nickel, chromium, iron, nickel-titanium alloy, cobalt-chromium alloy, gallium arsenide, titanium, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, poly epsilon- (caprolactone), polyanhydride, polyorthoester, polyvinyl alcohol, polyethylene glycol, polyurethane, polyacrylic acid, poly (N-isopropylacrylamide), poly (ethylene oxide) -poly (propylene oxide) -poly (ethylene oxide), polytetrafluoroethylene, polycarbonate, polyurethane, nitrocellulose, polystyrene, polyethylene terephthalate, polydimethylsiloxane, polyetheretherketone, silicon oxide, titanium oxide, aluminum oxide, niobium oxide, silicone rubber and glass. Including any of contact lenses, catheters, intravaginal or digestive tract instruments (gastric tubes, sigmoidoscopes, colonoscopes, gastroscopes), endotracheal tubes, bronchoscopes, dentures, orthodontic appliances, intrauterine devices, burn tissue dressings or treatment instruments, laparoscopes, arthroscopes, dental filling materials, artificial muscle keys, artificial throats, and sub-periosteal implants.
The second aspect of the invention provides the application of the surface hydrophilic layer modification method for the implantable medical device in biomedicine.
The invention provides a hydrophilic layer on the surface of an implantable medical device, which is characterized by being obtained by the method for modifying the hydrophilic layer on the surface of the implantable medical device.
The fourth aspect of the invention provides an implantable medical device with a hydrophilic layer modification, which is characterized by being obtained by the method for modifying the hydrophilic layer on the surface of the implantable medical device.
The technical scheme has the following advantages or beneficial effects: the invention provides a surface hydrophilic layer modification method for an implantable medical device and application, which modifies the surface of the medical device through plasma hydrophilic modification or hydrogel prepared from biocompatible water-soluble macromolecules and viscous components or biological extracts to form a hydrophilic layer on the surface of the medical device, and has the following advantages:
(1) the invention utilizes plasma, hydrogel and biological extract to modify the surface of implantable medical equipment, enhances the hydrophilic performance of the implantable medical equipment, and proves that the lubricity of the surface of the medical equipment is obviously improved through a lubricity test, the resistance of the medical equipment in the using process is obviously reduced, and the damage to tissues and organs is reduced, so that complications are reduced, and the durability test proves that the lubrication effect has excellent durability.
(2) The surface hydrophilic layer modification method for the implantable medical device provided by the invention has the advantages of simple process, convenience in operation, safety and environmental friendliness, and hydrogel modification and biological extract modification can be realized in a water phase without introducing an organic solvent, so that the surface hydrophilic layer modification method has good biocompatibility.
(3) The hydrogel modification provided by the invention increases the adhesive force between the hydrogel and the surface of the medical instrument by adding the adhesive component and uniformly dispersing the adhesive component in the system, so that the hydrogel can be tightly combined with the medical instrument and endows the medical instrument with certain durability.
(4) According to the invention, biological extracts such as surface mucus of kelp, surface mucus of fish and aloe mucus are selected to treat the medical instrument, so that excellent biocompatibility is endowed, meanwhile, the adhesive force between the surface hydrophilic layer and the surface of the medical instrument is increased, and the falling probability is reduced.
Detailed Description
The following examples are only a part of the present invention, and not all of them. Thus, the detailed description of the embodiments of the present invention provided below is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the invention without making creative efforts, belong to the protection scope of the invention.
Example 1
Wiping the surface of the laparoscope with ethanol and water, drying the laparoscope with nitrogen, placing the laparoscope in an oxygen plasma surface treatment instrument, vacuumizing the oxygen plasma surface treatment instrument to reduce the vacuum degree to-0.1, adjusting the voltage to 700V, and carrying out plasma surface treatment for 2min to generate hydrophilic groups on the surface of the laparoscope so as to realize the surface hydrophilic modification of oxygen plasma.
Hydrophilicity test: the contact angle of water of the laparoscope after hydrophilic modification is 20 degrees, and the contact angle of water of the laparoscope without modification is 108 degrees.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified laparoscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the hydrophilic modified laparoscope, the hydrophilic modified laparoscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified laparoscope, the friction coefficient of the laparoscope modified by the hydrophilic modification is reduced by 95%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 2
Wiping the surface of the gastroscope with ethanol and water, drying the gastroscope with nitrogen, placing the gastroscope in an oxygen plasma surface treatment instrument, vacuumizing to reduce the vacuum degree to-0.1, adjusting the voltage to 700V, and carrying out plasma surface treatment for 2min to generate hydrophilic groups on the surface of the gastroscope so as to realize the hydrophilic modification of the surface of the oxygen plasma.
Hydrophilicity test: the contact angle of water for the hydrophilic modified gastroscope was 24 °, and the contact angle of water for the unmodified gastroscope was 100 °.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified gastroscope is fixed in a modified clamp of a stress rheometer, 4N clamping force is applied to the hydrophilic modified gastroscope, the gastroscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified gastroscope, the friction coefficient of the hydrophilic modified gastroscope is reduced by 96 percent, and the friction coefficient is not obviously changed after multiple friction measurements.
Example 3
Wiping the surface of the artificial tendon with ethanol and water, drying with nitrogen, placing in an oxygen plasma surface treatment instrument, vacuumizing to reduce the vacuum degree to-0.1, adjusting the voltage to 700V, and performing plasma surface treatment for 2min to generate hydrophilic groups on the surface of the artificial tendon, thereby realizing the surface hydrophilic modification of oxygen plasma.
Hydrophilicity test: the contact angle of the water of the artificial tendon after hydrophilic modification is 15 degrees, and the contact angle of the water of the unmodified artificial tendon is 104 degrees.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the artificial tendon modified by the hydrophilicity is fixed in a modified clamp of a stress rheometer, 4N clamping force is applied to the artificial tendon, the artificial tendon is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with the unmodified artificial tendon, the friction coefficient of the artificial tendon subjected to hydrophilic modification is reduced by 97%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 4
Preparing a sodium alginate aqueous solution with the mass fraction of 5% and a dopamine solution with the mass fraction of 4%, uniformly mixing, uniformly dripping 5mL of the mixed solution into a die with the mass fraction of 3cm multiplied by 1cm multiplied by 200 mu m, and standing for 5h at the temperature of 25 ℃ to form a uniform film layer. And then, soaking the membrane layer in 0.1mol/L calcium chloride solution for complete crosslinking for 24 hours to form the sodium alginate hydrogel. In the system, after dopamine is oxidized and polymerized to form polydopamine, the uniformly dispersed polydopamine can increase the viscosity of the sodium alginate hydrogel, and then the hydrogel is taken out of the die and uniformly coated on the surface of the catheter, so that the hydrogel of the catheter is subjected to hydrophilic modification.
Hydrophilicity test: the contact angle of water of the catheter after hydrophilic modification is 10 degrees, and the contact angle of water of the catheter without modification is 100 degrees.
Adhesion testing: and (3) fixing the catheter coated with the hydrophilic layer on a stretcher, and testing the shear adhesion strength of the hydrophilic layer and the catheter, wherein the shear adhesion strength of the hydrophilic layer is 80kPa and is higher than the shear adhesion strength of commercial glue by 40 kPa.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified catheter is fixed in a modified clamp of a stress rheometer, 4N clamping force is applied to the hydrophilic modified catheter, the hydrophilic modified catheter is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified catheter, the friction coefficient of the hydrophilic modified catheter is reduced by 96%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 5
Preparing 5% polyacrylic acid aqueous solution and 4% dopamine solution, mixing uniformly, dripping 5mL of the mixed solution into a mold of 3cm × 1cm × 200 μm, and standing at 25 deg.C for 5h to form a uniform film layer. Subsequently, the film layer was subjected to pH 7.2 to prepare a polyacrylic acid hydrogel. In the system, after dopamine is oxidized and polymerized to form polydopamine, the uniformly dispersed polydopamine increases the viscosity of polyacrylic acid hydrogel, and then the hydrogel is taken out of a mould and uniformly coated on the surface of a bronchoscope, so that the hydrogel of the bronchoscope is subjected to hydrophilic modification.
Hydrophilicity test: the contact angle of water of the hydrophilic modified bronchoscope was 11 °, and the contact angle of water of the unmodified bronchoscope was 110 °.
Adhesion testing: fixing the bronchoscope coated with the hydrophilic layer on a stretching machine, and testing the shear adhesion strength of the hydrophilic layer and the bronchoscope, wherein the shear adhesion strength of the hydrophilic layer is 76kPa and is higher than that of commercial glue by 40 kPa.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified bronchoscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the hydrophilic modified bronchoscope, the hydrophilic modified bronchoscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified bronchoscope, the friction coefficient of the hydrophilic modified bronchoscope is reduced by 95%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 6
Preparing a polyvinyl alcohol aqueous solution with the mass fraction of 5% and a dopamine solution with the mass fraction of 4%, uniformly mixing, uniformly dripping 5mL of the mixed solution into a die with the mass fraction of 3cm multiplied by 1cm multiplied by 200 mu m, and standing for 5h at the temperature of 25 ℃ to form a uniform film layer. And then, freezing and thawing the film layer for multiple times at the temperature of-4-60 ℃ to form the polyvinyl alcohol hydrogel. In the system, after dopamine is oxidized and polymerized to form polydopamine, the uniformly dispersed polydopamine increases the viscosity of the polyvinyl alcohol hydrogel, and then the hydrogel is taken out of the mold and uniformly coated on the surface of the bronchoscope, so that the hydrophilic modification of the hydrogel of the bronchoscope is realized.
Hydrophilicity test: the contact angle of water of the hydrophilic modified bronchoscope was 9 °, and the contact angle of water of the unmodified bronchoscope was 102 °.
Adhesion testing: fixing the bronchoscope coated with the hydrophilic layer on a stretching machine, and testing the shear adhesion strength of the hydrophilic layer and the bronchoscope, wherein the shear adhesion strength of the hydrophilic layer is 70kPa and is higher than that of commercial glue by 40 kPa.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified bronchoscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the hydrophilic modified bronchoscope, the hydrophilic modified bronchoscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified bronchoscope, the friction coefficient of the hydrophilic modified bronchoscope is reduced by 95%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 7
Preparing 5% hydroxyethyl methacrylate aqueous solution, 4% polyethylene glycol diacrylate, 50 mu L of 2, 2-diethoxyacetophenone mixed solution and 4% dopamine solution by mass, uniformly mixing, uniformly dripping 5mL of the mixed solution into a die of 3cm multiplied by 1cm, and crosslinking for 10min under ultraviolet illumination to form the hydroxyethyl methacrylate hydrogel. In the system, after dopamine is oxidized and polymerized to form polydopamine, the uniformly dispersed polydopamine increases the viscosity of the sodium alginate hydrogel, and then the hydrogel is taken out of the mold and uniformly coated on the surface of the colonoscope, so that the hydrogel of the colonoscope is modified in a hydrophilic manner.
Hydrophilicity test: the contact angle of water for the hydrophilic modified colonoscope was 12 deg., and the contact angle of water for the unmodified colonoscope was 90 deg..
Adhesion testing: the colonoscope coated with the hydrophilic layer was fixed on a stretcher and the shear adhesion strength of the hydrophilic layer to the colonoscope was tested, the shear adhesion strength of the hydrophilic layer was 75kPa, which was 40kPa higher than that of commercial glues.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified colonoscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the colonoscope, the colonoscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
The friction coefficient of the hydrophilic modified colonoscope is reduced by 95 percent compared with that of the unmodified colonoscope, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 8
Preparing mannitol into a 2mol/L viscous water solution, soaking the arthroscope in mannitol mucus for 24h, and taking out to obtain the arthroscope treated by the extracting solution.
Hydrophilicity test: the contact angle of water in the hydrophilic-modified arthroscope was 9 °, and the contact angle of water in the unmodified arthroscope was 110 °.
Adhesion testing: and after the mannitol mucus is dried, fixing the joint endoscope coated with the mannitol mucus on a stretcher, and testing the shear adhesion strength of the hydrophilic layer and the joint endoscope, wherein the shear adhesion strength of the hydrophilic layer is 80kPa and is higher than that of the commercial glue by 40 kPa.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified arthroscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the arthroscope, the arthroscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified arthroscope, the friction coefficient of the arthroscope after hydrophilic modification is reduced by 96%, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 9
The fish used in this example is grass carp, but the invention is not limited thereto, and it should be noted that most fish have mucus material on their surface, and the invention is also suitable for practice and thus falls within the scope of the invention.
Preparing mucopolysaccharide into a 2mol/L viscous water solution, soaking the gastroscope in mucopolysaccharide mucus for 24h, and taking out to obtain the gastroscope after the extraction solution treatment.
Hydrophilicity test: the contact angle of water for the hydrophilic modified gastroscope was 14 °, and the contact angle of water for the unmodified gastroscope was 105 °.
Adhesion testing: and after the mucopolysaccharide is dried, fixing the gastroscope coated with the mucopolysaccharide mucus on a stretching machine, and testing the shear adhesion strength of the hydrophilic layer and the gastroscope, wherein the shear adhesion strength of the hydrophilic layer is 80kPa and is higher than the shear adhesion strength of the commercial glue by 40 kPa.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified gastroscope is fixed in a modified clamp of a stress rheometer, 4N clamping force is applied to the hydrophilic modified gastroscope, the gastroscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified gastroscope, the friction coefficient of the hydrophilic modified gastroscope is reduced by 95 percent, and after multiple friction measurements, the friction coefficient is not obviously changed.
Example 10
Preparing mannan into 2mol/L viscous water solution, soaking the arthroscope in mannan mucus, and taking out after soaking for 24h to obtain the arthroscope treated by the extracting solution.
Hydrophilicity test: the contact angle of water in the hydrophilic-modified arthroscope was 10 °, and the contact angle of water in the unmodified arthroscope was 113 °.
Adhesion testing: and after the kelp mucus is dried, fixing the arthroscope coated with the kelp mucus on a stretcher, and testing the shear adhesion strength of the hydrophilic layer and the arthroscope, wherein the shear adhesion strength of the hydrophilic layer is 83kPa and is 40kPa higher than that of commercial glue.
And (3) testing the lubricating performance and the durability: the friction coefficient can be used as an important index for measuring the lubricating performance of the hydrophilic layer, the hydrophilic modified arthroscope is fixed in a modified clamp of the stress rheometer, 4N clamping force is applied to the arthroscope, the arthroscope is started at a constant speed, the required tension is tested, and the ratio of the tension to the clamping force is the friction coefficient.
Compared with an unmodified arthroscope, the friction coefficient of the arthroscope after hydrophilic modification is reduced by 96%, and after multiple friction measurements, the friction coefficient is not obviously changed.
The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and all equivalent modifications made by the present invention in the specification or other related fields can be directly or indirectly applied thereto.
Claims (14)
1. The surface hydrophilic layer modification method for the implantable medical device is characterized by comprising plasma hydrophilic modification, hydrogel hydrophilic modification and biological extract modification.
2. The method for modifying the surface hydrophilic layer of the implantable medical device according to claim 1, wherein the process of modifying the hydrogel by hydrophilicity is as follows:
step 1 a: uniformly mixing a water-soluble polymer with biocompatibility and a certain amount of viscous components to prepare an aqueous solution with a certain concentration, drying to form a film, and then soaking the film in a divalent or trivalent metal cation solution for crosslinking to obtain hydrogel, or changing external conditions to realize crosslinking to obtain hydrogel;
step 1 b: mixing water-soluble polymer with biocompatibility, cross-linking agent, initiator and a certain amount of viscous component to prepare aqueous solution with a certain concentration, and crosslinking into hydrogel by ultraviolet irradiation, heating or radiation;
step 2: uniformly coating the hydrogel obtained in the step 1a or the step 1b on the surface of the medical device.
3. The method of claim 2, wherein the water-soluble polymer with biocompatibility in step 1a and step 1b is selected from sodium alginate, chitosan, hyaluronic acid, elastin, polypeptide, gelatin, collagen, peptidoglycan, agar, starch, cellulose, carboxymethyl chitin, polyhydroxyethyl methacrylate, dextran methacrylate, polymethacrylic acid, sodium polymethacrylate, polyacrylic acid, sodium polyacrylate, polyacrylamide, polyethylacrylic acid, polypropylenoacrylic acid, polyvinylbenzoic acid, polyisopropylacrylamide, polylysine, poly-L-glutamic acid, polyaspartic acid, polyglycine, polyitaconic acid, polyvinyl alcohol, carboxylated polyvinyl alcohol, polyoxyethylene, polyethylene glycol, and polyethylene glycol, or polyethylene glycol, or polyethylene glycol, or polyethylene glycol, or polyethylene glycol, or, One or more of polyethylene glycol diacrylate, polyurethane, polyvinylpyrrolidone, polymaleic anhydride and derivatives thereof.
4. The method for modifying the hydrophilic layer on the surface of the implantable medical device according to claim 2, wherein the viscous component in step 1a and step 1b is selected from any one of polydopamine, viscous protein and medical glue, and the mass fraction of the viscous component is 0.1% -20%.
5. The method for modifying a surface hydrophilic layer of an implantable medical device according to claim 2, wherein the water-soluble polymer and the viscous component are formulated into an aqueous solution with a concentration of 0.1mmol/L to 10mol/L in step 1 a; the divalent or trivalent metal cation is selected from Ca2+、Mg2+、Ba2+、Fe2+、Zn2+、Mn2+、Fe3+、Al3+And the like; the total concentration of the divalent or trivalent metal cations is 0.1mmol/L-10 mol/L; in step 1b, the concentration of the aqueous solution prepared from the water-soluble polymer, the cross-linking agent, the initiator and the viscous component is 0.1mmol/L-10 mol/L.
6. The method for modifying the surface hydrophilic layer of the implantable medical device according to claim 2, wherein the changing of the external condition in step 1a is changing the temperature or adjusting the pH, the temperature is in the range of-20 ℃ to-100 ℃, the pH is in the range of 1 to 14, and the crosslinking time is in the range of 1min to 24 h.
7. The method for modifying the surface hydrophilic layer of the implantable medical device according to claim 2, wherein in the step 1b, the mass fraction of the cross-linking agent is 0.1-20%, the mass fraction of the initiator is 0.1-20%, and the cross-linking time is 1min-24 h.
8. The method for modifying the surface hydrophilic layer of the implantable medical device according to claim 1, wherein the biological extract modification process is as follows:
preparing a biological extract containing a hydrophilic lubricating substance into a viscous aqueous solution, and then coating the viscous aqueous solution on the surface of the medical device, wherein the coating is any one selected from spray coating, dip coating, drop coating, spin coating and bioprinting;
the biological extract containing hydrophilic lubricating substance is at least one selected from surface mucus of herba Zosterae Marinae, fish surface mucus, snail mucus, Aloe mucus, and Agaricus campestris solution.
9. The method for modifying the surface hydrophilic layer of the implantable medical device according to claim 8, wherein the concentration of the viscous aqueous solution of the bio-hydrophilic lubricating substance is 0.1mmol/L-10mol/L, and the soaking time is 1-24 h.
10. The method as claimed in claim 1, wherein the degree of vacuum for the plasma hydrophilic modification is-0.1 to-0.095, the voltage is 600-800V, and the treatment time is 1-60 min.
11. The method of any one of claims 1-10, wherein the medical device is made of a material selected from the group consisting of gold, silver, platinum, palladium, copper, steel, tantalum, magnesium, nickel, chromium, iron, nickel-titanium alloy, cobalt-chromium alloy, gallium arsenide, titanium, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, poly-e- (caprolactone), polyanhydride, polyorthoester, polyvinyl alcohol, polyethylene glycol, polyurethane, polyacrylic acid, poly-N-isopropylacrylamide, poly (ethylene oxide) -poly (propylene oxide) -poly (ethylene oxide), polytetrafluoroethylene, polycarbonate, polyurethane, nitrocellulose, polystyrene, polyethylene terephthalate, polydimethylsiloxane, polyetheretherketone, silicon oxide, titanium oxide, aluminum oxide, titanium oxide, and titanium oxide, or titanium oxide, At least one material of niobium oxide, organic silicon, silicon rubber and glass.
12. The use of the method of any one of claims 1-10 for modifying a surface hydrophilic layer of an implantable medical device in biomedicine.
13. A hydrophilic layer on the surface of an implantable medical device, which is obtained by the method for modifying the hydrophilic layer on the surface of the implantable medical device according to any one of claims 1 to 10.
14. An implantable medical device with hydrophilic layer modification, which is obtained by the method for modifying the hydrophilic layer on the surface of the implantable medical device according to any one of claims 1 to 10.
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