CN114632191B - Interventional catheter with enhanced firmness of hydrophilic coating - Google Patents
Interventional catheter with enhanced firmness of hydrophilic coating Download PDFInfo
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- CN114632191B CN114632191B CN202210160660.0A CN202210160660A CN114632191B CN 114632191 B CN114632191 B CN 114632191B CN 202210160660 A CN202210160660 A CN 202210160660A CN 114632191 B CN114632191 B CN 114632191B
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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
- A61L29/02—Inorganic 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
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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
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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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
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
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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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
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Abstract
The invention belongs to the technical field of interventional medical treatment, and particularly relates to an interventional catheter with enhanced firmness of a hydrophilic coating. According to the invention, the metal photocatalyst is added into the base material of the interventional catheter, and the metal photocatalyst and one end of the polymer molecular chain of the hydrophilic coating generate a linking reaction so as to enhance the firmness between the base material and the coating, while the molecular chain which does not react with the base material can still rapidly absorb water molecules to form hydrogel, so that the excellent lubricity of the catheter is maintained.
Description
Technical Field
The invention belongs to the technical field of interventional medical treatment, and particularly relates to an interventional catheter with enhanced firmness of a hydrophilic coating.
Background
With the development of modern medical treatment level, the performance requirements of medical intervention catheters are continuously increased, and the lubricity of the catheters is also concerned more and more. Because the interventional catheter is usually made of high polymer materials, the surface of the interventional catheter is in a hydrophobic state, when the interventional catheter is used in a human body, large friction is easily generated between the interventional catheter and contacted tissues, so that pain is caused to a patient, blood vessels and tissues are damaged, infection is caused, and the like. Through intervene the stable hydrophilic polymer cross-linked network membrane of one deck that forms on catheter surface, can absorb a large amount of hydrones to form a hydrogel layer, very big reduction is intervene the frictional force between catheter and the human tissue, reduces to the damage of human tissue and the adhesion of pathogenic microorganism and breeds, can also improve the convenience of doctor's operation and the travelling comfort of disease simultaneously.
However, the hydrophilic coating of the current interventional catheter products has the problems of low firmness, more particles and easy shedding. Meanwhile, in the use process of the product, the activated hydrophilic coating is easy to touch or scratch with other instruments, so that the coating is damaged, the use of the product is influenced, and the risk of embolism exists in the fallen coating.
The method for enhancing the firmness of the coating commonly used in the market at present is methods such as surface chemical grafting of the catheter, an ultraviolet grafting technology, plasma modification, chemical plating, coating solution formula improvement and the like, so as to improve the linkage between the interventional catheter substrate and the hydrophilic lubricating layer, for example, the hydrophilic coating and the preparation method disclosed in the patent application of Chinese invention with the publication number of CN113354993A and 9/7/2021 are used for improving the components of the hydrophilic coating, and comprise the following raw materials in percentage by mass: 5-20% of hydrophilic polymer; 5-12% of adhesive resin; 0.1 to 2 percent of cross-linking agent; the balance of solvent; the mass-average molecular weight of the hydrophilic polymer is 300-600 ten thousand, and the hydrophilic coating prepared by matching the components has good surface lubricating property and base material adhesive force, can reduce the stimulation to human tissues and mucous membranes, reduce the pain of patients, and simultaneously can not introduce impurities and particles into human body fluid. However, these methods have the disadvantages of tedious operation, high improvement cost, or insignificant improvement of firmness, and also have poor stability, and the difference of adhesion between the hydrophilic coating and the substrate is large among different batches.
Disclosure of Invention
The invention aims to remarkably improve the firmness between a hydrophilic coating and a base material and the stability of the lubricating property of a product in a simple and easy-to-operate mode on the premise of keeping the lubricating property of the hydrophilic coating of the interventional catheter.
The invention adopts the following technical scheme:
an interventional catheter with enhanced firmness of a hydrophilic coating comprises a catheter body and the hydrophilic coating formed on the surface of the catheter body, wherein the catheter body comprises a base material and a metal photocatalyst.
According to the technical scheme, in the extrusion process of the pipe, the metal photocatalyst is added into the base material master batch of the pipe in a certain proportion, and the mixture is uniformly mixed and extruded into the pipe loaded with the metal photocatalyst in a specific size. Subsequently, the surface of the pipe is wiped and cleaned, and the hydrophilic coating is applied and cured. After the tube is coated with the hydrophilic coating solution, in the UV light curing process, the metal photocatalyst in the tube can be activated and generates a linking reaction with one end of a polymer molecular chain of the hydrophilic coating (compared with the condition that the metal photocatalyst is not added, the bonding between the metal photocatalyst in the tube and molecules in the coating polymer is increased, so that the firmness between the coating and a base material is increased), and the polymer molecular chain of the hydrophilic coating which is not linked with the metal photocatalyst is positioned on the outer side of the tube base layer, so that water molecules can be quickly absorbed through the hydrophilic group of the coating polymer when the tube is inserted into a human body, and hydrogel is formed, so that the tube has excellent lubricity. In conclusion, the metal photocatalyst is added into the interventional catheter, so that the firmness between the coating and the base material is obviously improved on the premise that the interventional catheter has excellent lubricity.
And through the mode that adds the metal photocatalyst in the base material of body and strengthen hydrophilic coating firmness, weakened the demand of matching nature between substrate and coating, enlarged the scope that coating solution is suitable for in different grade type substrates, and more can guarantee between different batches, hydrophilic coating firmness and lubricity's stability.
Preferably, the amount of the metal photocatalyst added is 10 to 50wt% of the base material. When the addition amount is less than 10WT%, the effect of remarkably improving the firmness of the hydrophilic coating cannot be achieved, the addition amount is too high, not only is the cost of the interventional catheter increased, but also the mechanical properties of the interventional catheter are adversely affected, for example, when the addition amount reaches 65WT%, the brittleness of the catheter is increased, and the softness is weakened. In addition, when the amount of the metal photocatalyst added is too high, the hydrophilicity of the hydrophilic coating layer is reduced, and the lubricity is affected.
In the above aspect, the metal photocatalyst is preferably a bismuth-based, titanium-based, or antimony-based photocatalyst.
More preferably a bismuth-based photocatalyst.
In the above aspect, the hydrophilic coating preferably contains polyvinylpyrrolidone, hyaluronic acid, polyacrylamide, polyethylene glycol, polyethylene oxide, or the like as a main component.
In the above aspect, the conduit is preferably made of a polymer such as polyamide, a modified polyamide, polytetrafluoroethylene, a polyethylene propylene copolymer, polyurethane, polyvinyl chloride, or polyethylene.
More preferably, the metal photocatalyst is a bismuth-based photocatalyst, the hydrophilic coating layer comprises polyvinylpyrrolidone as a main component, and the catheter is made of a polyamide modified body.
Preferably, the hydrophilic coating is cured by UV light, and the parameters of the UV light curing are as follows: UV illumination intensity is 200 to 600mW/cm 2 (ii) a Curing time: 100 to 600s.
Preferably, the thickness of the hydrophilic coating after curing is 5 to 30 μm. The thickness of the hydrophilic coating determines the linkage effect between the activated polymer molecules and the activated metal photocatalyst in the coating, but the lubricating effect of the hydrophilic coating needs to be ensured, and the firmness degree and the lubricating effect of the hydrophilic coating can be balanced by selecting the coating to be 5-30 mu m.
The invention also provides a preparation method of the interventional catheter, which comprises the following steps:
s-1, melting the base material of the pipe body, mixing the base material with the metal photocatalyst in a specific ratio, uniformly mixing the base material and the molten liquid of the pipe body, and forming the pipe containing the metal photocatalyst through an extruder; the process parameters of pipe extrusion are as follows: drying temperature of the particles: 90 to 150 ℃; extrusion temperature: 150 to 250 ℃; screw speed: 100 to 150r/min; the tube drawing ratio is as follows: 1.1 to 2.0.
S-2, forming a hydrophilic coating on the surface of the pipe, and curing by adopting UV light, wherein the UV light curing parameters are as follows: UV illumination intensity is 200 to 600mW/cm2; curing time: 100 to 600s.
Through the implementation of the technical scheme, the invention has the following beneficial effects:
1. according to the invention, the metal photocatalyst is added into the base material of the interventional catheter, and the metal photocatalyst and one end of the polymer molecular chain of the hydrophilic coating generate a linking reaction so as to enhance the firmness between the base material and the coating, while the molecular chain which does not react with the base material can still rapidly absorb water molecules to form hydrogel, so that the excellent lubricity of the catheter is maintained.
2. According to the invention, the metallic photocatalyst is added into the base material of the tube body to enhance the firmness of the hydrophilic coating, so that the requirement on the matching property between the base material and the coating is weakened, the applicable range of the coating solution in different types of base materials is expanded, and the firmness and the lubricity stability of the hydrophilic coating in different batches can be ensured.
Detailed Description
The present invention will be described in further detail with reference to specific embodiments. It is to be understood that the embodiments of the present invention are merely for illustrating the present invention and not for limiting the present invention, and that various substitutions and alterations made according to the common knowledge and conventional means in the art without departing from the technical idea of the present invention are included in the scope of the present invention.
Example one
An interventional catheter with enhanced firmness of a hydrophilic coating is characterized in that a tubing is made of Pebax 6333, the catheter is dried at 100 +/-5 ℃ until the water content is 1%, an added photocatalyst is BiOCl, the content of BiOCl is 50WT%, the speed of a screw is adjusted to be 100r/min, the catheter is extruded and molded at 190 +/-5 ℃ to form a specific catheter, and the drawing ratio of the tubing is 1.3. Wherein, the inner diameter of the pipe is 0.75mm, and the outer diameter is 0.90mm.
The method comprises the steps of coating a hydrophilic coating solution (jAqua hydrophilic super-smooth coating) with polyvinylpyrrolidone as a main component on the outer surface of the pipe, and curing by UV light, wherein the UV illumination intensity of the coating curing is 400mW/cm 2 And curing time: 200s, and a coating thickness of 23 μm was formed.
Example two
An interventional catheter with enhanced firmness of hydrophilic coating is characterized in that a tube is made of polyurethane, the tube is dried at the temperature of 110 +/-5 ℃ until the water content is 1%, and an added photocatalyst is Ti0 2 Wherein Ti0 2 The content of the composite material is 20 WT percent, the speed of a screw is adjusted to be 120r/min, and a specific conduit is formed after extrusion molding at the temperature of 150-155 ℃. Wherein the inner diameter of the pipe is 1.7mm, and the outer diameter is 2.7mm.
The method comprises the steps of coating a hydrophilic coating solution (Surflubri hydrophilic lubricating coating) with polyacrylamide as a main component on the outer surface of the pipe, and curing by UV light to obtain a coating with the UV illumination intensity of 300mW/cm 2 Securing ofTime of digestion: 300s, a coating thickness of 10 μm was formed.
EXAMPLE III
An interventional catheter with enhanced firmness of hydrophilic coating is characterized in that a pipe is made of polyurethane, the pipe is dried at 100-110 ℃ until the water content is 1%, and an added photocatalyst is Ti0 2 Wherein Ti0 2 The content of (A) is 10WT%, the screw speed is adjusted to 150r/min, and the special conduit is formed after extrusion molding at the temperature of 200 +/-5 ℃. Wherein the inner diameter of the pipe is 1.7mm, and the outer diameter is 2.7mm.
The method comprises the steps of coating a hydrophilic coating solution (Surflubri hydrophilic lubricating coating) with polyacrylamide as a main component on the outer surface of the pipe, and curing by UV light to obtain a coating with the UV illumination intensity of 300mW/cm 2 And curing time: 270s, a coating thickness of 30 μm was formed.
Comparative example 1
An interventional catheter is characterized in that a pipe material is Pebax 6333, the pipe material is dried at the temperature of 100 +/-5 ℃ until the water content is 1%, a metal photocatalyst is not added, the speed of a screw is adjusted to be 100r/min, the pipe material is extruded and molded at the temperature of 190 +/-5 ℃, a specific catheter is formed, and the drawing ratio of the pipe material is 1.3. Wherein, the inner diameter of the pipe is 0.75mm, and the outer diameter is 0.90mm. A hydrophilic coating solution (jAqua hydrophilic super-smooth coating) with polyvinylpyrrolidone as a main component is coated on the outer surface of the pipe and is cured by UV light. UV illumination intensity of coating curing is 400mW/cm 2 And curing time: 200s, a coating thickness of 23 μm was formed.
Comparative example No. two
An interventional catheter is characterized in that a pipe is made of polyurethane, the pipe is dried at the temperature of 110 +/-5 ℃ until the water content is 1%, a photocatalyst is not added, the speed of a screw is adjusted to be 120r/min, and the pipe is extruded and molded at the temperature of 150-155 ℃. Wherein, the inner diameter of the pipe is 1.7mm, and the outer diameter is 2.7mm.
The method comprises the steps of coating a hydrophilic coating solution (Surflubri hydrophilic lubricating coating) with polyacrylamide as a main component on the outer surface of the pipe, and curing by UV light to obtain a coating with the UV illumination intensity of 300mW/cm 2 And curing time: 300s, a coating thickness of 10 μm was formed.
Comparative example No. three
Interventional catheter and catheterThe material is polyurethane, the polyurethane is dried at the temperature of 100-110 ℃ until the water content is 1%, and a metal photocatalyst Ti0 is added 2 The amount added was 5WT%. Adjusting the screw speed to 150r/min, and forming a specific conduit after extrusion molding at 200 +/-5 ℃. Wherein, the inner diameter of the pipe is 1.7mm, and the outer diameter is 2.7mm.
The method comprises the steps of coating a hydrophilic coating solution (Surflubri hydrophilic lubricating coating) with polyacrylamide as a main component on the outer surface of the pipe, and curing by UV light to obtain a coating with the UV illumination intensity of 300mW/cm 2 And curing time: 270s, a coating thickness of 30 μm was formed.
Comparative example No. four
An interventional catheter is characterized in that a pipe material is made of polyurethane, the pipe material is dried at the temperature of 100-110 ℃ until the water content is 1%, and a metal photocatalyst Ti0 is added 2 The amount added was 65WT%. Adjusting the screw speed to 150r/min, and forming a specific conduit after extrusion molding at 200 +/-5 ℃. Wherein the inner diameter of the pipe is 1.7mm, and the outer diameter is 2.7mm.
The method comprises the steps of coating a hydrophilic coating solution (Surflubri hydrophilic lubricating coating) with polyacrylamide as a main component on the outer surface of a pipe, and curing by UV light, wherein the UV illumination intensity of the coating curing is 300mW/cm 2 And curing time: 270s, a coating thickness of 30 μm was formed.
Performance testing
1 frictional force test of coating
Cutting a coated sample by 15cm, fully soaking the coated sample in purified water for 60s, and then fixing the coated sample on a friction force testing machine to test the friction force; and (3) testing conditions are as follows: clamping force-300 g; the test length is-10 cm; the drawing speed is-10 mm/s; the test was repeated 20 times. After the friction force test is finished, the sample is placed in 1% Congo red for 30s, then is immersed in purified water for cleaning, and the coating integrity of the surface of the sample is observed.
Friction force test comparison table
As can be seen from the table, the catheter added with the metal photocatalyst has no significant difference in the lubricity of the coating compared with the catheter without the metal photocatalyst, the average friction force of the catheter is below 10g, and compared with similar products on the market, the catheter has no significant difference, thereby meeting the requirements of clinical use.
From the results of comparative example four, it can be seen that when the amount of the added metal photocatalyst reaches 65WT% which exceeds the preferable uppermost limit of 50WT% of the present invention, the average friction thereof is significantly increased, and the lubricity of the catheter is significantly reduced, failing to meet the requirements.
2 scratch test
The coated sample was thoroughly soaked in purified water for 60 seconds, and then the sample was taken out. Subsequently, the sample was passed through a metal scraping tool at a speed of 10 mm/s. Finally, the sample was placed in 1% congo red for 30s, and then immersed in purified water for washing, and the coating integrity of the sample surface was observed.
Scratch test comparison table
As can be seen from the table, the coating firmness of the conduit with the metal photocatalyst is significantly higher than that of the conduit without the metal photocatalyst, and the coating firmness gradually increases with the increase of the content of the metal photocatalyst.
In conclusion, the metal photocatalyst BiOCl and Ti0 are added 2 Compared with the sample without the metal photocatalyst, the firmness of the coating is obviously improved, the lubricating property of the coating is not obviously different, and the lubricating property is still very excellent.
Claims (3)
1. An interventional catheter with enhanced firmness of a hydrophilic coating comprises a catheter body and the hydrophilic coating formed on the surface of the catheter body, and is characterized in that the catheter body comprises a base material and a metal photocatalyst; the addition amount of the metal photocatalyst is 10 to 50WT% of the base material; the metal photocatalyst is a bismuth photocatalyst, the main component of the hydrophilic coating is polyvinylpyrrolidone, the catheter is made of a polyamide modified body, and the metal photocatalyst can be activated in the UV photocuring process and generates a linking reaction with one end of a polymer molecular chain of the hydrophilic coating.
2. The interventional catheter of claim 1, wherein the hydrophilic coating is cured by UV light, and the UV light curing parameters are as follows: UV illumination intensity is 200 to 600mW/cm 2 (ii) a Curing time: 100 to 600s.
3. The interventional catheter with the enhanced firmness of the hydrophilic coating as claimed in claim 2, wherein the thickness of the hydrophilic coating after curing is 5 to 30 μm.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102151357A (en) * | 2011-05-04 | 2011-08-17 | 南通伊诺精密塑胶导管有限公司 | Angiographic multi-cavity diameter-variable hydrophilic catheter |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6830785B1 (en) * | 1995-03-20 | 2004-12-14 | Toto Ltd. | Method for photocatalytically rendering a surface of a substrate superhydrophilic, a substrate with a superhydrophilic photocatalytic surface, and method of making thereof |
| JPH11100526A (en) * | 1997-09-29 | 1999-04-13 | Toto Ltd | Photocatalytic hydrophilic member and photocatalytic hydrophilic coating composition |
| JP2002113108A (en) * | 2000-10-06 | 2002-04-16 | Terumo Corp | Catheter non-adhesive to liquid-containing material |
| JP2006256083A (en) * | 2005-03-17 | 2006-09-28 | Nisshin Steel Co Ltd | Laminated metal sheet and hydrophilic coated metal sheet |
| TWI433895B (en) * | 2010-09-10 | 2014-04-11 | Onid Technology Corp | Super hydrophilic hybrid titania photocatalyst and its application methods without light irradiation or with insufficient light irradiation condition |
| CN107022101B (en) * | 2017-06-01 | 2020-09-08 | 广州新诚生物科技有限公司 | Massage unit and preparation method and application thereof |
| CN111012954B (en) * | 2018-10-10 | 2022-04-08 | 中国石油化工股份有限公司 | PVC composition for antibacterial hydrophilic catheter and preparation method thereof |
| AU2020304005A1 (en) * | 2019-06-25 | 2021-12-16 | Hollister Incorporated | Reusable urinary catheter products |
| EP4034181B1 (en) * | 2019-09-24 | 2024-03-13 | Hollister Incorporated | Reusable urinary catheter products |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102151357A (en) * | 2011-05-04 | 2011-08-17 | 南通伊诺精密塑胶导管有限公司 | Angiographic multi-cavity diameter-variable hydrophilic catheter |
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