CN106540336B - Hydrophilic modified coating on surface of medical interventional catheter - Google Patents
Hydrophilic modified coating on surface of medical interventional catheter Download PDFInfo
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- CN106540336B CN106540336B CN201611073783.1A CN201611073783A CN106540336B CN 106540336 B CN106540336 B CN 106540336B CN 201611073783 A CN201611073783 A CN 201611073783A CN 106540336 B CN106540336 B CN 106540336B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
Abstract
The invention discloses a hydrophilic modified coating on the surface of a medical interventional catheter, which consists of a transition layer coating and a lubricating layer coating, wherein the transition layer coating comprises the following components in parts by weight: 5-10 parts of bonding resin, 0.1-0.2 part of photoinitiator I, 0.05-0.1 part of flatting agent and 85-95 parts of solvent I; the lubricating layer coating comprises the following components in parts by weight: 5-10 parts of hydrophilic resin, 1-5 parts of water-based cross-linking agent, 0.2-0.5 part of photoinitiator II and 80-95 parts of solvent II. The invention comprises that the transition layer and the lubricating layer are all photocureable coatings, the curing time of the coatings is short, the energy consumption is low, and the mass production is convenient.
Description
Technical Field
The invention relates to a hydrophilic modified coating on the surface of a medical interventional catheter, belonging to the field of medical interventional catheters.
Technical Field
The interventional catheter is one of the most commonly used medical instruments and consumables in the medical process, the commonly used base materials are polyurethane, polyvinyl chloride, polyester and the like, and the materials are all hydrophobic materials, so that the interventional catheter is easy to be bonded with tissues in the using process to cause pain of patients and easily cause infection. The interventional catheter is subjected to hydrophilic modification, so that the lubricity of the interventional catheter can be improved, the discomfort of a patient when the interventional catheter is used is reduced, and the use safety of the interventional catheter is improved.
Regarding the design of hydrophilic modification and hydrophilic coating of interventional catheters, a large number of patents are reported in China, for example, patent CN102993407A discloses a method for modifying polyurethane by using a single-layer hydrophilic coating, the method firstly synthesizes a waterborne polyurethane and then copolymerizes the waterborne polyurethane with N-vinyl pyrrolidone and vinyl organic silicon to prepare a photocuring coating, the hydrophilic coating prepared by the method has the possibility of NVP monomer residue after curing, and the friction coefficient is larger after hydration; patent CN104448375A discloses a method for coating PVP on the surface of a PVC catheter after modification of a siloxane coupling agent, and a hydrophilic coating prepared by the method has a low friction coefficient but poor adhesion after hydration; patent CN103933616A discloses a modification method for grafting acrylic acid after conducting plasma treatment on a catheter and then coating a primer of waterborne polyurethane and a surface coating containing polymethyl vinyl ether-maleic anhydride. Patent CN103289499A discloses a method for preparing a photo-cured hydrophilic coating by using a hydrophilic resin containing a photo-active group in a polymer chain and a photo-active cross-linking agent, which has short curing time, but needs to synthesize a special photo-active resin in the preparation process, and has complicated resin production and purification processes and higher production cost.
Therefore, it is necessary to develop a hydrophilic lubricating coating which has the advantages of easily available materials, simple, convenient and quick production and curing method, good biocompatibility, excellent adhesion and lubricating performance and low cost.
Disclosure of Invention
The invention aims to provide a hydrophilic modified coating on the surface of a medical interventional catheter.
The hydrophilic modified coating on the surface of the medical interventional catheter is characterized by consisting of a transition layer coating and a lubricating layer coating, wherein the transition layer coating comprises the following components in parts by weight: 5-10 parts of bonding resin, 0.1-0.2 part of photoinitiator I, 0.05-0.1 part of flatting agent and 85-95 parts of solvent I; the lubricating layer coating comprises the following components in parts by weight: 5-10 parts of hydrophilic resin, 1-5 parts of water-based cross-linking agent, 0.2-0.5 part of photoinitiator II and 80-95 parts of solvent II.
The bonding resin is one or a mixture of two of unsaturated acrylic resin and unsaturated urethane acrylate.
The photoinitiator I is one or a composition of two of 1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone and 2-hydroxy-2-methyl-1-phenyl-1-acetone.
The leveling agent is one or a mixture of BKY333 produced by Picker and DC57 produced by Dow Corning.
The solvent I is one or a mixture of two of ethanol, isopropanol and ethyl acetate.
The hydrophilic resin is one or more of polyethylene glycol (PEG), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), hyaluronic acid, and N-vinylpyrrolidone-hydroxyethyl methacrylate copolymer (PVP-PHEMA).
The water-based cross-linking agent is polyethylene glycol diacrylate (PEG 600DA or PEG400 DA).
The photoinitiator II is one or a mixture of more than two of 1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone, 2-hydroxy-2-methyl-1-phenyl-1-acetone and benzophenone.
The solvent II is a mixture of more than two of methanol, ethanol, isopropanol and water.
The application method of the hydrophilic modified coating on the surface of the medical interventional catheter comprises the following steps: soaking the guide pipe cleaned by the ethanol in the transition layer coating for 10-30 seconds, then pulling the guide pipe at the speed of 1.0-1.5 cm/second to finish coating, and irradiating the guide pipe under an ultraviolet lamp of 1000W for 30-60 seconds to obtain the transition layer; the conduit with the coated transition layer is soaked in the lubricating layer coating for 10-30 seconds, then is pulled at the speed of 0.5-1.0 cm/second, and is irradiated under an ultraviolet lamp of 400W for 150-210 seconds to be completely cured.
The conduit is made of polyurethane, polyvinyl chloride or polyester.
The double bonds contained in the transition layer after being irradiated by ultraviolet light do not completely react, and the transition layer can completely react after being solidified by the lubricating layer, so that a chemical bond effect exists between the transition layer and the cross-linking agent of the lubricating layer, and the interaction force between the transition layer and the lubricating layer is improved.
An interpenetrating network structure is formed between the hydrophilic resin and the water-based cross-linking agent in the lubricating layer, so that the resin keeps good hydrophilic lubricating performance of the resin, and has good adhesive force due to being bound by the cross-linking agent.
The method for detecting the lubricity and stability of the hydrophilic lubricating layer on the surface of the interventional catheter comprises the following steps: a steel column having the same diameter as the inner diameter of the catheter was inserted into the catheter to keep the shape of the catheter unchanged, the catheter was horizontally fixed in a water tank containing water, immersed for 30 seconds, and subjected to a reciprocating friction test at different loads at a speed of 0.5 cm/sec using silica gel pieces as a pair on a dynamic and static friction test machine (14 WF, Shimadzu, Japan).
Compared with the prior art, the invention has the following beneficial effects:
1. the invention comprises that the transition layer and the lubricating layer are all photocureable coatings, the curing time of the coatings is short, the energy consumption is low, and the mass production is convenient.
2. The invention does not contain small molecular monomers and acidic groups, does not need to be provided with a step of removing unreacted monomers and a step of neutralization reaction in production, simplifies the production method, reduces the production cost and simultaneously improves the use safety of products.
3. The transition layer and the lubricating layer have chemical bond effect, an interpenetrating network structure is formed in the lubricating layer, the biocompatibility is good, the adhesive force of the lubricating layer is improved, and the good hydrophilic lubricating property of the hydrophilic resin is maintained.
4. The coating still has low friction coefficient under a large load after being wetted, and has good stability, and excellent stability and ultralow friction coefficient are still maintained after multiple times of friction.
Detailed Description
A hydrophilic modified coating on the surface of a medical interventional catheter consists of a transition layer coating and a lubricating layer coating, and the preparation methods of the transition layer coating and the lubricating layer coating are as follows:
preparing a transition layer coating: adding 5-10 parts of bonding resin into 50 parts of solvent I, fully stirring, adding 0.1-0.2 part of photoinitiator I under the condition of keeping out of the sun, supplementing 35-45 parts of solvent I after the initiator is completely dissolved, adjusting the viscosity to 4.0-5.0 mPa.s, adding 0.05-0.1 part of flatting agent, continuously stirring for 30 minutes, and packaging for later use;
preparing a lubricating layer coating: adding 0.2-0.5 part of photoinitiator II into 70-80 parts of solvent II, after full dissolution, adding 5-10 parts of hydrophilic resin and 1-5 parts of water-based cross-linking agent under uniform stirring, fully stirring for 5-8 hours, measuring viscosity after a uniform solution is formed, and adjusting the viscosity to 90-120 mPa & s by using 10-25 parts of solvent II.
The application of the hydrophilic modified coating on the surface of the medical interventional catheter comprises the following steps:
coating a transition layer: cleaning an interventional catheter in medical ethanol, drying the catheter by blowing, immersing the catheter into a transition layer coating at the speed of 3 cm/s for 10-30 seconds by a drawing machine, then finishing coating by drawing at the speed of 1.0-1.5 cm/s, quickly transferring the catheter to a 1000W ultraviolet lamp, irradiating for 30-60 seconds, taking out the catheter, and then placing the catheter in a clean place to avoid mutual contact of the catheters;
coating a lubricating layer: the guide pipe which is coated with the transition layer is immersed into the lubricating layer coating for 10 to 30 seconds by a pulling machine at the speed of 3 cm/second, then is pulled at the speed of 0.5 to 1.0 cm/second, and is quickly transferred into a curing box provided with a 400W ultraviolet lamp to be irradiated for 150 seconds and 210 seconds, so that the guide pipe can be completely cured.
A method for detecting the lubricity and stability of a hydrophilic lubricating layer on the surface of a medical interventional catheter comprises the following steps: a steel column having the same size as the inner diameter of the catheter was inserted into the catheter to keep the shape of the catheter unchanged, the catheter was horizontally fixed in a water tank containing water, immersed for 30 seconds, and subjected to a reciprocating friction test at a speed of 0.5 cm/sec using a silica gel sheet as a pair on a dynamic and static friction test machine (14 WF, Shimadzu, Japan) under different loads.
The invention is further described below in specific examples:
example 1
Preparing the coating:
adding 10 parts of unsaturated acrylic resin into 50 parts of ethyl acetate, fully stirring, adding 0.2 part of 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone under the condition of keeping out of the sun, adding 43 parts of isopropanol after an initiator is completely dissolved, measuring the viscosity of the solution to be 4.5 mPa & s, adding 0.1 part of a flatting agent BYK333, and continuously stirring for 30 minutes to obtain a transition layer coating; adding 0.3 part of benzophenone into 50 parts of ethanol and 25 parts of methanol, fully dissolving, adding 3.5 parts of PVP,1.5 parts of PEG and 1.0 part of aqueous cross-linking agent PEG400DA under uniform stirring, fully stirring for 7-8 hours, measuring the viscosity after a uniform solution is formed, and adjusting the viscosity to 90-95 mPa & s by using 10-20 parts of ethanol to obtain the lubricating layer coating.
The coating method comprises the following steps:
cleaning an interventional catheter in medical ethanol, drying the interventional catheter by blowing, immersing the catheter into the prepared transition layer coating at the speed of 3 cm/s by a drawing machine, finishing coating by drawing at the speed of 1.0 cm/s after immersing for 10 seconds, quickly transferring the catheter to a 1000W ultraviolet lamp, irradiating for 30 seconds, taking out the catheter, and then placing the catheter in a clean place to avoid the mutual contact of the catheters; then the guide tube which is coated with the transition layer is immersed into the prepared lubricating layer coating for 30 seconds at the speed of 3 cm/s through a pulling machine, and then is rapidly transferred into a curing box provided with a 400W ultraviolet lamp for irradiation for 180 seconds after being pulled at the speed of 1.0 cm/s, so that the coating can be completely cured.
And (3) performance testing:
a steel column having the same size as the inner diameter of the catheter was inserted into the catheter to maintain the shape of the catheter, the catheter was horizontally fixed in a water tank containing water, and after 30 seconds of immersion, a reciprocal friction test was conducted on a dynamic and static friction tester (14 WF, Shimadzu, Japan) for 20 cycles using silica gel pieces at a speed of 0.5 cm/sec under a load of 100 g,300 g, and 500 g, respectively, to obtain average friction coefficients of 0.020,0.023, and 0.028, respectively.
Example 2
Preparing the coating:
adding 8 parts of unsaturated polyurethane acrylate resin into a mixed solution of 25 parts of isopropanol and 25 parts of ethanol, fully stirring, adding 0.2 part of 2-hydroxy-2-methyl-1-phenyl-1-acetone under a dark condition, adding 40 parts of ethanol after an initiator is completely dissolved, measuring the viscosity of the solution to be 5 mPa & s, adding 0.05 part of flatting agent DC57, and continuously stirring for 30 minutes to obtain a transition layer coating; adding 0.5 part of 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone into a mixed solution of 40 parts of water and 30 parts of ethanol, fully dissolving, adding 0.5 part of PVA, 5.0 parts of PVP-PHEMA copolymer and 1.0 part of aqueous cross-linking agent PEG600DA under uniform stirring, fully stirring for 7-8 hours, measuring the viscosity after a uniform solution is formed, and adjusting the viscosity to 110-120 mPa & s by using 15-25 parts of ethanol to obtain the lubricating layer coating.
The coating method comprises the following steps:
cleaning an interventional catheter in medical ethanol, immersing the catheter into the prepared transition layer coating at the speed of 3 cm/s for 20 seconds by a lifting machine, then lifting at the speed of 1.5 cm/s to finish coating, quickly irradiating for 30 seconds under a 1000W ultraviolet lamp, taking out and then placing in a clean place to avoid mutual contact of the catheters; then the guide tube which is coated with the transition layer is immersed into the prepared lubricating layer coating for 30 seconds at the speed of 3 cm/s through a pulling machine, and then is rapidly transferred into a curing box provided with a 400W ultraviolet lamp to be irradiated for 210 seconds after being pulled at the speed of 0.5 cm/s, so that the coating can be completely cured.
And (3) performance testing:
the average friction coefficients obtained by conducting the reciprocating friction test for 20 cycles at a speed of 0.5 cm/sec under loads of 100 g,300 g and 500 g in the manner shown in example 1 were 0.018,0.022 and 0.029, respectively.
Example 3
Preparing the coating:
adding 10 parts of unsaturated polyurethane acrylate resin into a mixed solution of 30 parts of isopropanol and 20 parts of ethyl acetate, fully stirring, adding 0.1 part of 2-hydroxy-2-methyl-1-phenyl-1-acetone and 0.1 part of 1-hydroxycyclohexyl phenyl ketone under a dark condition, adding 38 parts of isopropanol after an initiator is completely dissolved, measuring the solution viscosity to be 4.3 mPa & s, adding 0.05 part of flatting agent BYK333, and continuously stirring for 30 minutes to obtain a transition layer coating; adding 0.3 part of 1-hydroxycyclohexyl phenyl ketone and 0.2 part of 2-hydroxy-2-methyl-1-phenyl-1-acetone into a mixed solution of 30 parts of ethanol, 20 parts of methanol and 20 parts of water, after the mixture is fully dissolved, adding 2.0 part of polyethylene glycol (PEG), 5.5 parts of polyvinylpyrrolidone (PVP), 0.5 part of hyaluronic acid and 2.0 part of water cross-linking agent PEG600DA under uniform stirring, fully stirring for 7-8 hours, measuring the viscosity after a uniform solution is formed, and adjusting the viscosity to be 110 mPas with 10-25 parts of ethanol to obtain the lubricating layer coating.
The coating method comprises the following steps:
cleaning an interventional catheter in medical ethanol, immersing the catheter into the prepared transition layer coating at the speed of 3 cm/s for 30 seconds by a lifting machine, then lifting at the speed of 1.0 cm/s to finish coating, quickly irradiating for 30 seconds under a 1000W ultraviolet lamp, taking out and then placing in a clean place to avoid mutual contact of the catheters; then the guide tube which is coated with the transition layer is immersed into the prepared lubricating layer coating for 30 seconds at the speed of 3 cm/s through a pulling machine, and then is rapidly transferred into a curing box provided with a 400W ultraviolet lamp to be irradiated for 150 seconds after being pulled at the speed of 1.0 cm/s, so that the coating can be completely cured.
And (3) performance testing:
the friction coefficients of 0.014,0.020 and 0.025, respectively, were obtained by conducting a reciprocal friction experiment at a speed of 0.5 cm/sec for 20 cycles under loads of 100 g,300 g and 500 g, respectively, in the method shown in example 1.
Claims (7)
1. The hydrophilic modified coating on the surface of the medical interventional catheter is characterized by consisting of a transition layer coating and a lubricating layer coating, wherein the transition layer coating comprises the following components in parts by weight: 5-10 parts of bonding resin, 0.1-0.2 part of photoinitiator I, 0.05-0.1 part of flatting agent and 85-95 parts of solvent I; the lubricating layer coating comprises the following components in parts by weight: 5-10 parts of hydrophilic resin, 1-5 parts of water-based cross-linking agent, 0.2-0.5 part of photoinitiator II and 80-95 parts of solvent II;
the photoinitiator I is one or a composition of two of 1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone and 2-hydroxy-2-methyl-1-phenyl-1-acetone; the photoinitiator II is one or a mixture of more than two of 1-hydroxycyclohexyl phenyl ketone, 2-hydroxy-4' - (2-hydroxyethoxy) -2-methyl propiophenone and 2-hydroxy-2-methyl-1-phenyl-1-acetone;
the bonding resin is one or a mixture of two of unsaturated acrylic resin and unsaturated urethane acrylate;
the hydrophilic resin is one or a composition of more than two of polyethylene glycol, polyvinyl alcohol, polyvinylpyrrolidone, hyaluronic acid and N-vinyl pyrrolidone-hydroxyethyl methacrylate copolymer.
2. The coating composition of claim 1, wherein the leveling agent is one or a mixture of BKY333 from Picker, DC57 from Dow Corning.
3. The hydrophilic modified paint as claimed in claim 1, wherein the solvent I is one or two of ethanol, isopropanol and ethyl acetate; the solvent II is a mixture of more than two of methanol, ethanol, isopropanol and water.
4. The hydrophilically modified coating composition according to claim 1, wherein said aqueous crosslinking agent is polyethylene glycol diacrylate.
5. The hydrophilic modified coating for the surface of a medical interventional catheter as defined in any one of claims 1 to 4, which is applied by the method comprising: soaking the guide pipe cleaned by the ethanol in the transition layer coating for 10-30 seconds, then pulling the guide pipe at the speed of 1.0-1.5 cm/second to finish coating, and irradiating the guide pipe under an ultraviolet lamp of 1000W for 30-60 seconds to obtain the transition layer; the conduit with the coated transition layer is soaked in the lubricating layer coating for 10-30 seconds, then is pulled at the speed of 0.5-1.0 cm/second, and is irradiated under an ultraviolet lamp of 400W for 150-210 seconds to be completely cured.
6. The hydrophilic modified coating of claim 1, wherein the catheter is made of polyurethane, polyvinyl chloride, or polyester.
7. The hydrophilic modified coating of claim 1, wherein the lubricity and stability of the hydrophilic lubricating layer formed by the transition layer and the lubricating layer formed on the surface of the catheter are measured by: inserting a steel column with the same diameter and the same inner diameter as the guide pipe into the guide pipe to keep the shape of the guide pipe unchanged, horizontally fixing the guide pipe in a water tank filled with water, soaking for 30 seconds, and performing reciprocating friction experiments on different loads at the speed of 0.5 cm/s by taking a silica gel sheet as a pair on a dynamic and static friction experiment machine.
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| CN107412883B (en) * | 2017-04-27 | 2019-12-17 | 大连理工大学 | hydrophilic super-smooth coating for surface of medical instrument and preparation method thereof |
| CN107376029A (en) * | 2017-07-17 | 2017-11-24 | 江西丰临医疗科技股份有限公司 | A kind of medical hydrophilic lubrication coating and its method for coating |
| CN107868269A (en) * | 2017-12-12 | 2018-04-03 | 湖南平安医械科技有限公司 | A kind of light proofing infusion apparatus catheter surface method of modifying |
| CN109954169B (en) * | 2017-12-25 | 2021-09-14 | 江苏百赛飞生物科技有限公司 | Coating composition, coating method and coated product |
| CN109851831B (en) * | 2018-12-27 | 2021-04-09 | 脉通医疗科技(嘉兴)有限公司 | Medical tube and preparation method thereof |
| CN114306883A (en) * | 2022-01-05 | 2022-04-12 | 聚辉医疗科技(深圳)有限公司 | Method for manufacturing microcatheter and microcatheter |
| CN115487362B (en) * | 2022-09-21 | 2023-07-04 | 上海康德莱医疗器械股份有限公司 | Ultra-violet cured super-hydrophilic super-lubrication double-layer coating system for catheter and guide wire |
| CN115779159B (en) * | 2022-12-01 | 2024-01-16 | 中山大学 | High-strength and high-toughness wear-resistant hydrophilic lubricating coating grafted on surface of medical instrument and preparation method thereof |
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