Hydrophilic coating for catheters and devices
阅读说明：本技术 导管亲水涂层及器械 (Hydrophilic coating for catheters and devices ) 是由 周宁辉 刘震杰 解荡 于 2019-12-05 设计创作，主要内容包括：本发明公开了一种导管亲水涂层,包括底涂层和面涂层,所述底涂层包括水性树脂、三官能氮丙啶交联剂和纯化水；所述面涂层包括透明质酸钠、三官能氮丙啶交联剂、磷酸盐或三羟甲基氨基甲烷和纯化水；所述面涂层通过酸调节pH至7-10。本发明提供的导管亲水涂层,具有较低的摩擦力,生物相容性高同时不易脱落,降低使用过程中对患者的损伤。(The invention discloses a catheter hydrophilic coating, which comprises a bottom coating and a top coating, wherein the bottom coating comprises a water-based resin, a trifunctional aziridine crosslinking agent and purified water; the topcoat comprises sodium hyaluronate, a trifunctional aziridine crosslinking agent, phosphate or tris (hydroxymethyl) aminomethane, and purified water; the topcoat is adjusted to a pH of 7-10 by an acid. The hydrophilic coating of the catheter provided by the invention has lower friction, high biocompatibility and low possibility of falling off, and reduces the damage to patients in the using process.)
1. A catheter hydrophilic coating is characterized by comprising a bottom coating and a surface coating,
the primer layer comprises a waterborne resin, a trifunctional aziridine crosslinking agent, and purified water;
the topcoat comprises sodium hyaluronate, a trifunctional aziridine crosslinking agent, phosphate or tris (hydroxymethyl) aminomethane, and purified water;
the topcoat is adjusted to a pH of 7-10 by an acid.
2. The catheter hydrophilic coating of claim 1, wherein the primer coating comprises 5-30 wt%
0.05 to 9 weight percent of trifunctional aziridine crosslinking agent and 60 to 95 weight percent of purified water.
3. The catheter hydrophilic coating of claim 1, wherein the base coat further comprises a hydrophilic aliphatic polyisocyanate and/or sodium hyaluronate.
4. The catheter hydrophilic coating of claim 3, wherein the primer layer comprises 0-0.1 wt% sodium hyaluronate, 0-10 wt% hydrophilic aliphatic polyisocyanate, and wherein the sodium hyaluronate and the hydrophilic aliphatic polyisocyanate are not both present at 0.
5. The hydrophilic catheter coating of claim 1, wherein the topcoat layer comprises 0.05-5 wt% sodium hyaluronate, 0.01-8 wt% trifunctional aziridine crosslinking agent, 0.02-1 wt% phosphate or tris (hydroxymethyl) aminomethane, and 80-99.9 wt% purified water.
6. The hydrophilic catheter coating of claim 5, wherein the topcoat layer comprises 0.1-3 wt% sodium hyaluronate, 0.01-1 wt% trifunctional aziridine crosslinking agent, 0.02-1 wt% phosphate buffer or tris (hydroxymethyl) aminomethane, and 80-99.9 wt% purified water.
7. The catheter hydrophilic coating of claim 1, wherein the water-based resin in the primer coating is selected from one or more of water-based silicone resin, polyurethane resin, acrylic resin, polyester resin and phenolic resin dispersion.
8. The hydrophilic coating of claim 1, wherein the molecular weight of the sodium hyaluronate in the top and bottom coatings is 150 and 280 ten thousand daltons.
9. The catheter hydrophilic coating of claim 1 wherein the topcoat layer is adjusted to a pH of 7-10 by dilute hydrochloric acid or low concentration sodium hydroxide.
10. The catheter hydrophilic coating of claim 1, wherein the ratio of solids content of the primer coating to the topcoat coating is 5-25: 1.
11. a preparation method of a catheter hydrophilic coating comprises the steps of forming a base coating on a medical catheter according to any one of claims 1 to 10 by adopting a dip coating mode, drying a sample after the base coating is finished, performing surface coating on the sample by adopting the dip coating mode to form a surface coating after the sample is cooled, and drying the sample again after the surface coating is finished.
12. The method for preparing a hydrophilic coating for a catheter according to claim 11, wherein the surface of the medical catheter is cleaned before the primer coating is formed; the drying temperature of the base coat is 50-80 ℃, and the time is 30-120 min; and after finishing top coating, drying the sample at the temperature of 50-80 ℃ for 4-24 h.
13. A device which is a catheter having a coating, wherein the coating is a hydrophilic coating for the catheter of any one of claims 1-10.
14. A device which is a catheter having a coating, wherein the coating is the hydrophilic coating of the catheter of any one of claims 1 to 10, and the hydrophilic coating of the catheter is prepared by the preparation method of claim 11 or 12.
Technical Field
The invention belongs to the technical field of hydrophilic coatings of biological materials, and particularly relates to a hydrophilic coating of a medical catheter and a preparation method thereof.
Background
Most of the existing coating formulation technologies adopt organic solvent resin or partially adopt water-soluble resin. The hydrophilic coating catheters prepared by the technologies have the problems of low biocompatibility of products, unqualified detection of chemical indexes such as sample evaporation residues and the like, or high friction force of prepared hydrophilic coating samples, insufficient coating firmness and the like, so that the products are in danger of damaging patients when used in vascular access.
As described in the patent applicationPatent document 1, patent application No. 201610665468.1, discloses a hydrophilic coating for medical catheters comprising SiO-containing layer having hydrophilic group2A high molecular polymer of nanoparticles, urethane, silicone or silicone emulsion. For example,
At present, microcatheters used in clinical interventional operations have the problems of poor conductivity, severe damage to patients caused by the falling-off of coatings of part of coated catheters with poor biocompatibility, surgical intervention, adverse tissue reactions, thrombosis and the like, and the research and the development of a water-soluble coating with good conductivity and excellent biocompatibility are urgently needed.
Disclosure of Invention
The medical catheter is provided with a hydrophilic coating, has low friction, high biocompatibility and low possibility of falling off, and reduces the damage to patients in the use process.
The invention aims to provide a preparation method of a hydrophilic coating of a medical catheter, which can prepare the hydrophilic coating with low friction, high biocompatibility and difficult shedding.
The technical scheme of the invention is as follows:
a hydrophilic coating for medical catheter comprises a bottom coating and a surface coating,
the primer layer comprises a waterborne resin, a trifunctional aziridine crosslinking agent, and purified water;
the topcoat comprises sodium hyaluronate, a trifunctional aziridine crosslinking agent, phosphate or tris (hydroxymethyl) aminomethane, and purified water;
the topcoat is adjusted to a pH of 7-10 by an acid.
Preferably, the primer layer comprises 5 to 30 wt% of the aqueous resin, 0.05 to 9 wt% of the trifunctional aziridine crosslinking agent, and 60 to 95 wt% of purified water.
Preferably, the base coat further comprises hydrophilic aliphatic polyisocyanate and/or sodium hyaluronate.
Preferably, the base coat comprises 0-0.1 wt% of sodium hyaluronate, 0-10 wt% of hydrophilic aliphatic polyisocyanate and 60-95 wt% of purified water, and the content of the sodium hyaluronate and the content of the hydrophilic aliphatic polyisocyanate are not 0 at the same time.
Preferably, the topcoat comprises 0.05 to 5 wt% of sodium hyaluronate, 0.01 to 8 wt% of a trifunctional aziridine crosslinking agent, 0.02 to 1 wt% of phosphate or tris (hydroxymethyl) aminomethane, and 80 to 99.9 wt% of purified water.
Preferably, the topcoat comprises 0.1-3 wt% of sodium hyaluronate, 0.01-1 wt% of a trifunctional aziridine crosslinking agent, 0.02-1 wt% of a phosphate buffer or tris (hydroxymethyl) aminomethane, and 80-99.9 wt% of purified water.
Preferably, the water resin in the primer layer is one or more selected from water-based silicone resin, polyurethane resin, acrylic resin, polyester resin and phenolic resin dispersion.
Preferably, the molecular weight of the sodium hyaluronate in the top coat layer and the bottom coat layer is 150-280 ten thousand daltons.
Preferably, the topcoat is adjusted to a pH of 7-10 by dilute hydrochloric acid or low concentration sodium hydroxide.
Preferably, the solid content mass ratio of the base coat to the top coat is 5-25: 1.
the invention also provides a preparation method of the medical catheter hydrophilic coating, which comprises the steps of forming a bottom coating on the medical catheter by adopting a dip-coating mode, drying a sample after the bottom coating is finished, performing surface coating on the sample by adopting the dip-coating mode to form a surface coating after the sample is cooled, and drying the sample again after the surface coating is finished.
Preferably, the surface of the medical catheter is cleaned before the base coating is formed; the drying temperature of the base coat is 50-80 ℃, and the time is 30-120 min; and after finishing top coating, drying the sample at the temperature of 50-80 ℃ for 4-24 h.
The invention also provides a catheter having a coating, the coating being a hydrophilic coating of the catheter as defined in any one of the above.
The invention also provides a catheter, which is provided with a coating, wherein the coating is the hydrophilic coating of the catheter, and the hydrophilic coating of the catheter is prepared by the preparation method.
Compared with the prior art, the invention has the following beneficial effects:
the medical catheter hydrophilic coating uses sodium hyaluronate as a hydrophilic lubricating layer, has no toxic or side effect and good biocompatibility, has an average friction force value of 2-15g, has a very low force value, ensures that the catheter hardly feels resistance when moving back and forth in a vascular passage, achieves the aim of 0 injury of a patient, and has excellent firmness and performance.
According to the invention, sodium hyaluronate is added into both the bottom coating and the top coating, so that a more stable space network structure is formed between the top coating and the bottom coating through crosslinking, and compared with the addition of only the top coating, the sodium hyaluronate added in both the two layers is crosslinked under the action of a crosslinking agent to form a network structure, so that the whole coating system is crosslinked to form a network structure, namely, the top coating and the bottom coating are meshed together, and the coating firmness is improved.
The invention adjusts the pH value by acid, so that the cross-linking agent used in the formula has more ideal effect in alkaline environment.
The molecular weight of the sodium hyaluronate is 150-280 kilodaltons, the sodium hyaluronate with the molecular weight of 100 kilodaltons generally shows good lubricating property, the hydrophilic coating of the sodium hyaluronate can be degraded to different degrees in the preparation and long-term storage processes of products, the viscosity of the solution with the molecular weight being too high is increased, the process difficulty is increased, and the molecular weight range of the sodium hyaluronate used in the invention is suitable for avoiding the loss of the lubricating property of the coating and considering the production process difficulty.
The determination of the using amount of the water-based resin in the base coat needs to be combined with the preferential determination of the low-viscosity high-solid content index of the solution, and the using amount of the water-based resin is between 5 and 30 weight percent and is a proper using amount.
Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.
Drawings
FIG. 1 is a graph showing the results of the friction force test of the sample of example 1 of the present invention;
FIG. 2 is a graph showing the results of the friction force test of sample 1 of example 3;
FIG. 3 is a graph showing the results of the friction force test of
FIG. 4 is a graph showing the results of the friction force test of
FIG. 5 is a graph showing the results of the friction force test of sample 4 of comparative example 2;
FIG. 6 is a graph showing the results of the friction force test of
fig. 7 is a graph showing the results of the friction force test of
Detailed Description
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. In practice, the invention will be understood to cover all modifications and variations of this invention provided they come within the scope of the appended claims.
For a better illustration of the invention, the following detailed description of the invention is given in conjunction with the accompanying drawings.
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