CN106880876A - A kind of preparation method of the antimicrobial coating of Implantable Medical Device - Google Patents
A kind of preparation method of the antimicrobial coating of Implantable Medical Device Download PDFInfo
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- CN106880876A CN106880876A CN201710103575.XA CN201710103575A CN106880876A CN 106880876 A CN106880876 A CN 106880876A CN 201710103575 A CN201710103575 A CN 201710103575A CN 106880876 A CN106880876 A CN 106880876A
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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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D1/00—Processes for applying liquids or other fluent materials
- B05D1/32—Processes for applying liquids or other fluent materials using means for protecting parts of a surface not to be coated, e.g. using stencils, resists
- B05D1/322—Removable films used as masks
- B05D1/325—Masking layer made of peelable film
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
- B05D3/10—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by other chemical means
- B05D3/102—Pretreatment of metallic substrates
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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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
- A61L2300/604—Biodegradation
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
-
- 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
-
- 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
- A61L2420/06—Coatings containing a mixture of two or more compounds
-
- 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
- A61L2420/08—Coatings comprising two or more layers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D2508/00—Polyesters
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D2518/00—Other type of polymers
Abstract
The invention provides a kind of preparation method of the antimicrobial coating of Implantable Medical Device, comprise the following steps：Implantable Medical Device is soaked in the solution containing dopamine and is processed, nitrogen drying is standby at room temperature after taking-up, obtains surface-treated Implantable Medical Device；Mask plate is enclosed within the metal parts of surface-treated Implantable Medical Device, then coating solution is sprayed at the surface of Implantable Medical Device；Mask plate is removed, treats that solvent volatilizees completely, obtain the Implantable Medical Device containing antimicrobial coating；Wherein, the shape of mask plate matches with the shape of the metal parts of Implantable Medical Device, and hole is opened up on the surface of mask plate.The preparation method of the antimicrobial coating of the Implantable Medical Device that the present invention is provided overcomes and only carries out the limitation of coating treatment in titanium plate surface in the prior art, solves the problems, such as to carry out antimicrobial coating treatment to the active implantable medical devices surface with labyrinth.
Description
Technical field
The invention belongs to field of medical device, it is related to a kind of preparation method of the antimicrobial coating of Implantable Medical Device.
Background technology
Implantable Medical Device (IMD：Implantable medical devices) on the one hand give treatment to big for human body
The sufferer of amount, but some negative interactions are there is also simultaneously, it is exactly the most typically to infect.
During typical IMD such as Pacemaker implantations, a pouch can be made subcutaneous, although pacemaker can use aseptic before implantation
Packaging, and implantation is also to carry out in an aseptic environment, but it has been also difficult to avoid that microorganism enters pouch.Therefore, preoperative doctor
It is raw can be at the skin of surgical incision site using disinfectant or antiseptic (such as chlorohexidene, gluconate, Iodophor, isopropanol, second
Alcohol etc.), disinfectant or antiseptic (gentamicin, vancomycin etc.) can be also directly used before cut closure, after surgery
Convalescence separately can carry out pre- aseptic generation using oral absorption medicine (such as gentamicin, rifamycin, vancomycin), to the greatest extent
Pipe in this way, but infection still can occur.According to statistics, after these measures are taken, the incidence for clinically infecting is up to 2%.To the greatest extent
The incidence of pipe infection is low, but once pouch infects, infection can move to heart, brain, vertebra along electrode or conduit
The position that pipe or other electrodes or conduit can be reached, the pain of making patients, and bring huge economy to bear to family members
Load, under serious conditions even threat to life.When generation is infected, even if taking antibiotic therapy, due to the implantation instrument for infecting
Surface has formed biomembrane, it is difficult to killed by antibiotic, therefore therapeutic effect is not obvious.Therefore, should just think at the implantation initial stage
The generation that method is avoided infection.
Topical remedy's release is the most efficient method avoided infection, and on the one hand can reduce drug dose, it is to avoid non-disease
The drug toxicity of its hetero-organization of stove part；On the other hand drug effect can be improved, medicine is directly acted on lesions position；Therefore
Topical remedy's release is extensively paid close attention in medical instruments field by developers.If antimicrobial treatment can be carried out to pacemaker surface,
Itself play antibacterial action after making Pacemaker implantation, so that it may so that pouch Infection probability reduce, and then reduce treatment cost and
Patient suffering.
Titanium is often used in existing medicine equipment, it is exactly titanium implant (such as bone, tooth, pass that its is most common
The part of section or other soft tissue implants) and some active implantable medical devices (including pacemaker, heart
Cardioverter defibrillators, nerve stimulation instrument, spinal cord stimulators, cardiac resynchronization therapy defibrillator, cardiac resynchronization therapy pacemaker
Deng).When the method discharged using topical remedy carries out antimicrobial treatment to the surface of these medicine equipments, typically using antimicrobial coating
The method of modification.
Have to the method that titanium implant surface carries out antimicrobial coating modification a lot, be first that surface is carried out to surface of metal titanium
To make it easier to be combined with active material, the method for surface treatment includes Mechanical Method, chemical treatment, heat treatment, anode for treatment
Oxidizing process, micro-arc oxidation etc.；Then it is soaked in again in the coating solution of pastille so that medicine and pharmaceutical carrier attachment or grafting
In surface of metal titanium.Active implantable medical devices are compared to titanium sheet or orthopaedics implant, joint implant, the tooth of titanium base material
Implant etc., with complex structure, in irregular shape, composition material species is more the features such as, by taking pacemaker as an example, its surface
Material of main part be the electrode cable connector of titanium shell and silica gel and polyurethane material, there be complicated circuit and each inside
Planting component, therefore antimicrobial coating modification is carried out to pacemaker surface can only use gentle surface treatment and coating process, with
Avoid the destruction to pacemaker important feature unit and function.
In the above-mentioned method for titanium implant surface treatment, Mechanical Method is such as ground, polishing method can be to medicine equipment
The structure of itself is damaged, and is not suitable for being molded the active implantable medical devices that assemble or can not again through structure
The implantation instrument of processing；Although chemical treatment is such as in the alkali lye of heat, and treatment can be effectively improved the activity of metal surface,
Be not suitable for being molded the active implantable medical devices for assembling, there is what internal circuit or other working of plastics were corroded
Risk；Heat treatment also brings along and problem as chemical treatment class；The equipment that anodic oxidation and micro-arc oxidation are required for complexity,
Processing cost is higher.
In the prior art, when the antimicrobial coating for Medical Devices is prepared, there is provided suppress doctor using composition
The method for treating growth of microorganism in equipment surface, bactericidal composition is mainly made up of polypeptide and polyureas-resinous copolymeric siloxane thing, the two
With reference to play a part of suppress biofilm development.Specifically way is：APTES (3- aminopropyl triethoxies are used first
Silane) titanium plate surface is coated in, glucose oxidase glutaraldehyde is fixed on titanium plate surface after solidification, then by tetrahydrofuran
Polyureas-the silicon resin copolymer of dissolving is coated in titanium plate surface.But such scheme has that coating material is nondegradable.
Existing coating process is also more, such as dip-coating, spraying, roller coating, brushing, and the adhesion of coating will primarily be examined
Worry factor, dip-coating, roller coating, brushing are more suitable for the material that shape is regular, substrate is homogeneous, coating to the surface with labyrinth
Can cause that regional area is uneven, there is extension drop phenomenon.Additionally, suitable surface treatment mode is also selected, so that coating
What is combined with complex surface is more preferable, improves coating binding force.Therefore, suitable method is found to active implantable medical devices
Metal surface carries out treatment has larger challenge.
The content of the invention
It is an object of the invention to provide the preparation method of the antimicrobial coating of Implantable Medical Device, overcome in the prior art
The limitation of coating treatment is only carried out in titanium plate surface, solution is carried out to the active implantable medical devices surface with labyrinth
The problem of antimicrobial coating treatment.
In order to solve the above technical problems, the preparation method of the antimicrobial coating the invention provides Implantable Medical Device, bag
Include following steps：
S1：The Implantable Medical Device is soaked in the solution containing dopamine and is processed, after taking-up at room temperature
Nitrogen drying is standby, obtains surface-treated Implantable Medical Device；
S2：Mask plate is enclosed within the metal parts of the surface-treated Implantable Medical Device, then by coating
Solution spraying is in the surface of the Implantable Medical Device；
S3：The mask plate is removed, treats that solvent volatilizees completely, obtain the Implantable Medical Device containing antimicrobial coating；
Wherein, the shape of the mask plate matches with the shape of the metal parts of the Implantable Medical Device, described
Hole is opened up on the surface of mask plate.
Optionally, the Implantable Medical Device (IMD) can be pacemaker, cardioverter-defibrillator, nerve thorn
Swash instrument, spinal cord stimulators, cardiac resynchronization therapy defibrillator or cardiac resynchronization therapy pacemaker etc..
Further, the solution containing dopamine is the Tris-HCl solution of dopamine, in the S1, by the plant
Entering property medicine equipment is processed 4-24 hours in being soaked in the Tris-HCl solution of dopamine.
Optionally, in the Tris-HCl solution of the dopamine, the concentration of dopamine is 0.02-0.05mol/L, solution
PH value is 8.5.
Further, the mask plate is made of dimethyl silicone polymer (PDMS).
Optionally, described hole is shaped as circular or polygon, polygon can for triangle, square, rhombus and/or
Pentagon, the thickness of the mask plate is 0.1-2mm, and porosity is 60%-90%, and hole is evenly distributed.
Further, the coating solution is made up of medicine, polymer and solvent, and the quality of the medicine accounts for the coating
The 0.1%-3% of solution quality, the quality of the polymer accounts for the 1%-5% of the coating solution quality, the matter of the solvent
Amount accounts for the 92%-98.9% of the coating solution quality.
Used as preferred, coating solution described in the S2 at least includes two kinds, respectively first coating solution and second
Coating solution, the first coating solution is made up of medicine, polymer and solvent；The second coating solution at least includes polymerization
Thing and solvent；The S2 is specifically included：Mask plate is enclosed within the metal parts of the surface-treated Implantable Medical Device
On, the first coating solution and the second coating solution are then sprayed at the Implantable Medical Device successively respectively
Surface.
Further, in the first coating solution, the quality of the medicine accounts for the first coating solution quality
0.1%-3%, the quality of the polymer accounts for the 1%-5% of the first coating solution quality, and the quality of the solvent accounts for institute
State the 92%-98.9% of first coating solution quality.
Optionally, in the second coating solution, the second coating solution is made up of polymer and solvent, wherein,
The quality of the polymer accounts for the 1%-5% of the second coating solution quality, and the quality of the solvent accounts for the second coating
The 95%-99% of solution quality.
Optionally, the second coating solution is made up of medicine, polymer and solvent, wherein, the quality of the medicine is accounted for
The 0.1%-3% of the second coating solution quality, the quality of the polymer accounts for the 1%- of the second coating solution quality
5%, the quality of the solvent accounts for the 92%-98.9% of the second coating solution quality.
Optionally, the medicine is selected from one or more combination in anodyne, antiseptic, anti-inflammatory agent and arcotic.
Preferably, the anodyne is selected from one or more in aspirin, brufen, bupivacaine and celecoxib
Combination.
Preferably, the antiseptic be selected from rifampin, minocycline, gentamicin, macrolide, penicillin, tetracycline,
Chloramphenicol, vancomycin, Fusidic Acid, methoxybenzyl aminopyrimidine, lindamycin, triclosan, chlorohexidene, cynnematin, ammonia are bent
It is south, cefotetan, Loracarbef, Cefaclor, Ceftizoxime, Cefixime, cephazoline, cefalexin, penicillin, new
One or more combination in mycin and colistin, or selected from one or more combination in the salt of these compounds.
Preferably, the anti-inflammatory agent is selected from naproxen, Ketoprofen, brufen, Diclofenac, celecoxib, sulindac, two
Fluorine Buddhist nun willow, piroxicam, Indomethacin, Meloxicam, Flurbiprofen, mefenamic acid, Nabumetone, tolmetin, ketone
One or more combination in acid, choline magnesium, aspirin, salicylic acid and acetylsalicylate is coughed up, or selected from these compounds
Salt in one or more combination.
Preferably, the arcotic be selected from lidocaine, Bupivacaine, Carbocainum, to acetyl phenol, clonidine, benzene
Phenodiazine, Flumazenil, carbamazepine, pethidine, Zaleplon, maleic acid trimethylbenzene miaow piperazine, buprenorphine, Nalbuphine, U.S. sand
One or more combination in ketone, Dilauid, hydrocodone and morphine.
Further, the polymer be selected from polyglutamic acid, polylysine, poly-aspartate, polyethylene glycol, PLA,
One or more combination in polycaprolactone, PGA and makrolon, or selected from the copolymer of these compounds
Plant or multiple combination.
Further, the solvent is selected from water, ethanol, methyl alcohol, tetrahydrofuran, hexafluoroisopropanol, trifluoroethanol, trifluoro second
One or more combination in acid, dichloromethane, chloroform, dimethylformamide, ethyl acetate and acetone.
Optionally, in step s 2, by the coating solution by the way of electrostatic spraying, ultrasound spraying or aerial spraying
It is sprayed at the surface of the Implantable Medical Device.
Further, the area of the antimicrobial coating accounts for the 60%-90% of the Implantable Medical Device surface area, described
The quality of antimicrobial coating accounts for the 0.1%-0.8% of the Implantable Medical Device gross mass containing antimicrobial coating.
In Implantable Medical Device prepared by the preparation method provided using the present invention, antimicrobial coating is to Staphylococcus aureus
The bacteriostasis rate of bacterium, EHEC and pseudomonas aeruginosa reaches more than 98%, and the release time of medicine is 3- in antimicrobial coating
14 days.
Compared with prior art, the advantage of the preparation method of the antimicrobial coating of the Implantable Medical Device that the present invention is provided exists
In：
1st, the metal parts and silica gel connector or other plastic components of antimicrobial coating and embedded type medical apparatus surface are same
When have good coating binding force；
2. the surface distributed of the metal parts of Implantable Medical Device has the perforated of non-coating, has on the one hand been conducive to
Fight the directly contact of device and tissue fluid, help the normal work under its monopolar regime；On the other hand medicine is increased with tissue fluid
Contact area, can promote the degraded of coating material and the release of medicine；
3. the preparation process is simple that the present invention is provided, it is only necessary to which shirtsleeve operation is to be capable of achieving Implantable Medical Device surface
Antimicrobial coating, it is easy to large-scale production.
Brief description of the drawings
Fig. 1 be the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention preparation method in implantable medical treatment
The structural representation of apparatus；
Fig. 2 be the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention preparation method in it is surface-treated
The Implantable Medical Device structural representation；
Fig. 3 be the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention preparation method in the mask that uses
The structural representation of version；
Fig. 4 be the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention preparation method in by mask plate set
Overall structural representation after on the metal parts of surface-treated Implantable Medical Device；
Fig. 5 be the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention preparation method in obtain containing anti-
The structural representation of the Implantable Medical Device of bacterium coating；
Fig. 6 is the flow chart of the preparation method of the antimicrobial coating of Implantable Medical Device provided in an embodiment of the present invention.
Wherein, 1- Implantable Medical Devices；The 2- surface-treated Implantable Medical Device；3- mask plates；4- resists
Bacterium coating.
Specific embodiment
Preparation below in conjunction with the drawings and specific embodiments to the antimicrobial coating of Implantable Medical Device proposed by the present invention
Method is described in further detail.According to following explanation and claims, advantages and features of the invention will become apparent from.Need
Bright, accompanying drawing in the form of simplifying very much and uses non-accurately ratio, is only used to conveniently, lucidly aid in illustrating
The purpose of the embodiment of the present invention.
Embodiment 1
As shown in figs 1 to 6, the invention provides Implantable Medical Device antimicrobial coating preparation method, it is including as follows
Step：
S1：The Implantable Medical Device 1 is soaked in the solution containing dopamine and is processed, after taking-up at room temperature
Nitrogen drying is standby, obtains surface-treated Implantable Medical Device 2；
S2：Mask plate 3 is enclosed within the metal parts of the surface-treated Implantable Medical Device 2, then will be applied
Layer solution spraying is in the surface of the Implantable Medical Device；
S3：The mask plate is removed, treats that solvent volatilizees completely, obtain the Implantable Medical Device containing antimicrobial coating 4；
Wherein, the shape of the mask plate 3 matches with the shape of the metal parts of the Implantable Medical Device 1, institute
Hole is opened up on the surface for stating mask plate 3.Preferably, the mask plate 3 is made of dimethyl silicone polymer (PDMS).
In such scheme, the Implantable Medical Device (IMD) 1 can for pacemaker, cardioverter-defibrillator,
Nerve stimulation instrument, spinal cord stimulators, cardiac resynchronization therapy defibrillator or cardiac resynchronization therapy pacemaker etc..
Wherein, the solution containing dopamine is the Tris-HCl solution of dopamine, in the S1, by the implantable
Medicine equipment 1 is processed 4-24 hours in being soaked in the Tris-HCl solution of dopamine.In the Tris-HCl solution of the dopamine,
The pH value of solution is 8.5, and the concentration of dopamine is 0.02-0.05mol/L, preferably 0.02mol/L, the implantable Medical treatment device
Tool soaks 4h in the Tris-HCl solution of dopamine.
Optionally, the void shape on the surface of the mask plate 3 is circular or polygon, and polygon can be triangle, side
Shape, rhombus and/or pentagon, the porosity of the mask plate 3 is 60%-90%, and hole is evenly distributed.As preferred,
The hole on the surface of the mask plate 3 is circular port, and aperture is 2mm, and porosity is 60%, and the thickness of the mask plate 3 is 0.1-
2mm。
Further, the coating solution is made up of medicine, polymer and solvent, and the quality of the medicine accounts for the coating
The 0.1%-3% of solution quality, the quality of the polymer accounts for the 1%-5% of the coating solution quality, the matter of the solvent
Amount accounts for the 92%-98.9% of the coating solution quality.
Further, coating solution described in the S2 at least includes two kinds, respectively first coating solution and second
Coating solution, the first coating solution is made up of medicine, polymer and solvent；The second coating solution at least includes polymerization
Thing and solvent；The S2 is specifically included：Mask plate 3 is enclosed within the metal portion of the surface-treated Implantable Medical Device 2
On part, the first coating solution and the second coating solution are then sprayed at the Implantable Medical Device successively respectively
Surface.
Wherein, in the first coating solution, the quality of the medicine accounts for the first coating solution quality
0.1%-3%, the quality of the polymer accounts for the 1%-5% of the first coating solution quality, and the quality of the solvent accounts for institute
State the 92%-98.9% of first coating solution quality.
In the second coating solution, the second coating solution can be made up of polymer and solvent, wherein, it is described
The quality of polymer accounts for the 1%-5% of the second coating solution quality, and the quality of the solvent accounts for the second coating solution
The 95%-99% of quality.
The second coating solution can also include medicine, be made up of medicine, polymer and solvent, wherein, the medicine
Quality account for the 0.1%-3% of the second coating solution quality, the quality of the polymer accounts for the second coating solution matter
The 1%-5% of amount, the quality of the solvent accounts for the 92%-98.9% of the second coating solution quality.
In such scheme, the medicine is selected from one or more group in anodyne, antiseptic, anti-inflammatory agent and arcotic
Close.
The anodyne is selected from one or more combination in aspirin, brufen, bupivacaine and celecoxib.
The antiseptic be selected from rifampin, minocycline, gentamicin, macrolide, penicillin, tetracycline, chloramphenicol,
Vancomycin, Fusidic Acid, methoxybenzyl aminopyrimidine, lindamycin, triclosan, chlorohexidene, cynnematin, AZT, cephalo
For smooth, Loracarbef, Cefaclor, Ceftizoxime, Cefixime, cephazoline, cefalexin, penicillin, neomycin and
One or more combination in colistin, or selected from one or more combination in the salt of these compounds.
The anti-inflammatory agent be selected from naproxen, Ketoprofen, brufen, Diclofenac, celecoxib, sulindac, Diflunisal,
Piroxicam, Indomethacin, Meloxicam, Flurbiprofen, mefenamic acid, Nabumetone, tolmetin, ketorolac, courage
One or more combination in alkali magnesium, aspirin, salicylic acid and acetylsalicylate, or selected from the salt of these compounds
One or more combination.
The arcotic be selected from lidocaine, Bupivacaine, Carbocainum, to acetyl phenol, clonidine, benzene phenodiazine, fluorine
Ma Xini, carbamazepine, pethidine, Zaleplon, maleic acid trimethylbenzene miaow piperazine, buprenorphine, Nalbuphine, methadone, dihydro
One or more combination in hydromorphone, hydrocodone and morphine.
The polymer be selected from polyglutamic acid, polylysine, poly-aspartate, polyethylene glycol, PLA, polycaprolactone,
One or more combination in PGA and makrolon, or selected from one or more group in the copolymer of these compounds
Close.
The solvent is selected from water, ethanol, methyl alcohol, tetrahydrofuran, hexafluoroisopropanol, trifluoroethanol, trifluoroacetic acid, dichloromethane
One or more combination in alkane, chloroform, dimethylformamide, ethyl acetate and acetone.
Preferably, in the present embodiment, by mass percentage, the component of the coating solution is：0.1% medicine,
1% polymer and 98.9% solvent.
Wherein, medicine is preferably lindamycin；Polymer is preferably poly- L-lactic acid；Solvent be preferably dichloromethane with
The mixed solution of dimethylformamide, the amount of both materials is 3:1.
In above-mentioned steps S2, by coating solution spray by the way of electrostatic spraying, ultrasound spraying or aerial spraying
It is applied to the surface of the Implantable Medical Device.In the present embodiment preferably by the way of electrostatic spraying.
In the IMD containing antimicrobial coating for preparing, the area of the antimicrobial coating accounts for the Implantable Medical Device table
The 60%-90% of area, the quality of the antimicrobial coating accounts for the Implantable Medical Device gross mass containing antimicrobial coating
0.1%-0.8%, preferably 0.1%, the release time of medicine is 3 days in antimicrobial coating.
Embodiment 2
The preparation method of the antimicrobial coating of the Implantable Medical Device provided in the present embodiment is substantially the same manner as Example 1,
It is described only for difference below.
In the present embodiment, the solution containing dopamine in the step S1 is the Tris-HCl solution of dopamine, molten
The pH value of liquid is 8.5, and the concentration of dopamine is 0.03mol/L, Tris- of the Implantable Medical Device in dopamine in solution
6h is soaked in HCl solution.
The mask plate in the step S2 is made of dimethyl silicone polymer (PDMS), the hole on mask plate surface
It is square opening, the size in hole is 2mm × 2mm, and porosity is 70%.
The coating solution is made up of medicine, polymer and solvent, by mass percentage, the component of the coating solution
For：1% medicine, 2% polymer and 97% solvent.
Wherein, medicine is preferably rifampin；Polymer is preferably the copolymer of lactic acid and glycolide；Solvent is preferably tetrahydrochysene
Furans.
In the step S2, coating solution is sprayed at the Implantable Medical Device by the way of ultrasound spraying
Surface.
In the IMD containing antimicrobial coating for preparing, the quality of the antimicrobial coating accounts for the implantation containing antimicrobial coating
Property medicine equipment gross mass 0.3%, in antimicrobial coating the release time of medicine be 7 days.
Embodiment 3
The preparation method of the antimicrobial coating of the Implantable Medical Device provided in the present embodiment is substantially the same manner as Example 1,
It is described only for difference below.
In the present embodiment, the solution containing dopamine in the step S1 is the Tris-HCl solution of dopamine, molten
The pH value of liquid is 8.5, and the concentration of dopamine is 0.04mol/L, Tris- of the Implantable Medical Device in dopamine in solution
8h is soaked in HCl solution.
The mask plate in the step S2 is made of dimethyl silicone polymer (PDMS), the hole on mask plate surface
It is circular port, aperture is 3mm, and porosity is 80%.
The coating solution is made up of medicine, polymer and solvent, by mass percentage, the component of the coating solution
For：3% medicine, 5% polymer and 92% solvent.
Wherein, medicine is preferably cynnematin；Polymer is preferably polyethylene glycol-polylactic acid-polyglutamic acid three block and is total to
Polymers；Solvent is preferably dichloromethane.
In the step S2, coating solution is sprayed at the Implantable Medical Device by the way of aerial spraying
Surface.
In the IMD containing antimicrobial coating for preparing, the quality of the antimicrobial coating accounts for the implantation containing antimicrobial coating
Property medicine equipment gross mass 0.5%, in antimicrobial coating the release time of medicine be 9 days.
Embodiment 4
The preparation method of the antimicrobial coating of the Implantable Medical Device provided in the present embodiment is substantially the same manner as Example 1,
It is described only for difference below.
In the present embodiment, the solution containing dopamine in the step S1 is the Tris-HCl solution of dopamine, molten
The pH value of liquid is 8.5, and the concentration of dopamine is 0.04mol/L, Tris- of the Implantable Medical Device in dopamine in solution
8h is soaked in HCl solution.
The mask plate in the step S2 is made of dimethyl silicone polymer (PDMS), the hole on mask plate surface
It is circular port, aperture is 3mm, and porosity is 80%.
Coating solution in the step S2 includes first coating solution and second coating solution.
The first coating solution is made up of medicine, polymer and solvent, and by mass percentage, the first coating is molten
The component of liquid is：3% medicine, 5% polymer and 92% solvent.Wherein, medicine is preferably cynnematin；Polymer is excellent
Elect polyethylene glycol-polylactic acid-polyglutamic acid triblock copolymer as；Solvent is preferably dichloromethane.
The second coating solution is made up of polymer and solvent, by mass percentage, the second coating solution
Component is：5% polymer and 95% solvent.Wherein, polymer is preferably polyglutamic acid；Solvent is preferably water.
In the step S2, successively by the first coating solution and the second coating by the way of aerial spraying
Solution is sprayed at the surface of the Implantable Medical Device respectively.
In the IMD containing antimicrobial coating for preparing, the quality of the antimicrobial coating accounts for the implantation containing antimicrobial coating
Property medicine equipment gross mass 0.5%, release time of medicine is 14 days.
Embodiment 5
The preparation method of the antimicrobial coating of the Implantable Medical Device provided in the present embodiment is substantially the same manner as Example 1,
It is described only for difference below.
In the present embodiment, the solution containing dopamine in the step S1 is the Tris-HCl solution of dopamine, molten
The pH value of liquid is 8.5, and the concentration of dopamine is 0.03mol/L, Tris- of the Implantable Medical Device in dopamine in solution
6h is soaked in HCl solution.
The mask plate in the step S2 is made of dimethyl silicone polymer (PDMS), the hole on mask plate surface
It is square opening, the size in hole is 2mm × 2mm, porosity is 70%.
The coating solution is made up of medicine, polymer and solvent, by mass percentage, the component of the coating solution
For：1% medicine, 2% polymer and 97% solvent.
Wherein, medicine is preferably the combination of rifampin and minocycline (both mass ratioes is 1:1)；Polymer is preferably
The copolymer of lactic acid and glycolide；Solvent is preferably the mixed solution of tetrahydrofuran and methyl alcohol, and (both volume ratios are 9:1).
In the step S2, coating solution is sprayed at the Implantable Medical Device by the way of aerial spraying
Surface.
In the IMD containing antimicrobial coating for preparing, the quality of the antimicrobial coating accounts for the implantation containing antimicrobial coating
Property medicine equipment gross mass 0.6%, release time of medicine is 12 days.
Embodiment 6
The preparation method of the antimicrobial coating of the Implantable Medical Device provided in the present embodiment is substantially the same manner as Example 1,
It is described only for difference below.
In the present embodiment, the solution containing dopamine in the step S1 is the Tris-HCl solution of dopamine, molten
The pH value of liquid is 8.5, and the concentration of dopamine is 0.05mol/L, Tris- of the Implantable Medical Device in dopamine in solution
24h is soaked in HCl solution.
The mask plate in the step S2 is made of dimethyl silicone polymer (PDMS), the hole on mask plate surface
It is pentagon hole, the length of side in hole is 3mm, and porosity is 90%.
Coating solution in the step S2 includes first coating solution and second coating solution.
The first coating solution is made up of medicine, polymer and solvent, and by mass percentage, the first coating is molten
The component of liquid is：1% medicine, 1% polymer and 98% solvent.Wherein, medicine is preferably cynnematin；Polymer is excellent
Elect polyethylene glycol-polylactic acid-polyglutamic acid triblock copolymer as；Solvent is preferably dichloromethane.
The second coating solution is made up of medicine, polymer and solvent, and by mass percentage, the second coating is molten
The component of liquid is：1% medicine, 1% polymer and 98% solvent.Wherein, medicine is preferably carbamazepine；Polymer is excellent
Elect the copolymer of lactic acid and glycolide as；Solvent is preferably chloroform.
In the step S2, successively by the first coating solution and the second coating by the way of ultrasound spraying
Solution is sprayed at the surface of the Implantable Medical Device respectively.
In the IMD containing antimicrobial coating for preparing, the quality of the antimicrobial coating accounts for the implantation containing antimicrobial coating
Property medicine equipment gross mass 0.8%, release time of medicine is 14 days.
The advantage of preparation method of the antimicrobial coating of the Implantable Medical Device that the present invention is provided is：
1st, the metal parts and silica gel connector or other plastic components of antimicrobial coating and embedded type medical apparatus surface are same
When have good coating binding force；
2. the surface distributed of the metal parts of Implantable Medical Device has the perforated of non-coating, has on the one hand been conducive to
Fight the directly contact of device and tissue fluid, help the normal work under its monopolar regime；On the other hand medicine is increased with tissue fluid
Contact area, can promote the degraded of coating material and the release of medicine；
3. the preparation process is simple that the present invention is provided, it is only necessary to which shirtsleeve operation is to be capable of achieving Implantable Medical Device surface
Antimicrobial coating, it is easy to large-scale production.
Each embodiment is described by the way of progressive in this specification, and what each embodiment was stressed is and other
The difference of embodiment, between each embodiment identical similar portion mutually referring to.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair
Any change, modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims
Scope.
Claims (18)
1. a kind of preparation method of the antimicrobial coating of Implantable Medical Device, it is characterised in that comprise the following steps：
S1：The Implantable Medical Device is soaked in the solution containing dopamine and is processed, obtain surface-treated
Implantable Medical Device；
S2：Mask plate is enclosed within the metal parts of the surface-treated Implantable Medical Device, then by coating solution
It is sprayed at the surface of the Implantable Medical Device；
S3：The mask plate is removed, the Implantable Medical Device containing antimicrobial coating is obtained；
Wherein, the shape of the mask plate matches with the shape of the metal parts of the Implantable Medical Device, the mask
Hole is opened up on the surface of version.
2. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 1, it is characterised in that described to contain
There is the solution of dopamine for the Tris-HCl solution of dopamine, in the S1, the Implantable Medical Device is soaked in DOPA
Processed in the Tris-HCl solution of amine 4-24 hours, then nitrogen drying is standby.
3. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 2, it is characterised in that described many
In the Tris-HCl solution of bar amine, the concentration of dopamine is 0.02-0.05mol/L, and the pH value of solution is 8.5.
4. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 1, it is characterised in that described to cover
Film version is made of dimethyl silicone polymer, and its thickness is 0.1-2mm, and porosity is 60%-90%, and hole is evenly distributed.
5. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 1, it is characterised in that the painting
Layer solution is made up of medicine, polymer and solvent；The quality of the medicine accounts for the 0.1%-3% of the coating solution quality, institute
The quality for stating polymer accounts for the 1%-5% of the coating solution quality, and the quality of the solvent accounts for the coating solution quality
92%-98.9%.
6. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 1, it is characterised in that the S2
Described in coating solution at least include two kinds, respectively first coating solution and second coating solution, the first coating solution
It is made up of medicine, polymer and solvent, the second coating solution at least includes polymer and solvent；
The S2 includes：Mask plate is enclosed within the metal parts of the surface-treated Implantable Medical Device, Ran Houfen
The first coating solution and the second coating solution are not sprayed at the surface of the Implantable Medical Device successively.
7. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 6, it is characterised in that described
In one coating solution：The quality of the medicine accounts for the 0.1%-3% of the first coating solution quality, the quality of the polymer
The 1%-5% of the first coating solution quality is accounted for, the quality of the solvent accounts for the 92%- of the first coating solution quality
98.9%.
8. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 6, it is characterised in that described
Two coating solutions are made up of polymer and solvent, wherein, the quality of the polymer accounts for the second coating solution quality
1%-5%, the quality of the solvent accounts for the 95%-99% of the second coating solution quality.
9. the preparation method of the antimicrobial coating of Implantable Medical Device according to claim 6, it is characterised in that described
Two coating solutions are made up of medicine, polymer and solvent, wherein, the quality of the medicine accounts for the second coating solution quality
0.1%-3%, the quality of the polymer accounts for the 1%-5% of the second coating solution quality, and the quality of the solvent accounts for institute
State the 92%-98.9% of second coating solution quality.
10. the preparation method of the antimicrobial coating of the Implantable Medical Device according to claim any one of 5-9, its feature exists
In the medicine is selected from one or more combination in anodyne, antiseptic, anti-inflammatory agent and arcotic.
The preparation method of the antimicrobial coating of 11. Implantable Medical Devices according to claim 10, it is characterised in that described
Anodyne is selected from one or more combination in aspirin, brufen, bupivacaine and celecoxib.
The preparation method of the antimicrobial coating of 12. Implantable Medical Devices according to claim 10, it is characterised in that described
Antiseptic is selected from rifampin, minocycline, gentamicin, macrolide, penicillin, tetracycline, chloramphenicol, vancomycin, husband
The acid of western ground, methoxybenzyl aminopyrimidine, lindamycin, triclosan, chlorohexidene, cynnematin, AZT, cefotetan, chlorine carbon head
In spore, Cefaclor, Ceftizoxime, Cefixime, cephazoline, cefalexin, penicillin, neomycin and colistin
One or more combination, or selected from one or more combination in the salt of these compounds.
The preparation method of the antimicrobial coating of 13. Implantable Medical Devices according to claim 10, it is characterised in that described
Anti-inflammatory agent is selected from naproxen, Ketoprofen, brufen, Diclofenac, celecoxib, sulindac, Diflunisal, piroxicam, Yin
Diindyl U.S. is pungent, Meloxicam, Flurbiprofen, mefenamic acid, Nabumetone, tolmetin, ketorolac, choline magnesium, Ah Si
One or more combination in woods, salicylic acid and acetylsalicylate, or selected from one kind in the salt of these compounds or many
Plant combination.
The preparation method of the antimicrobial coating of 14. Implantable Medical Devices according to claim 10, it is characterised in that described
Arcotic be selected from lidocaine, Bupivacaine, Carbocainum, to acetyl phenol, clonidine, benzene phenodiazine, Flumazenil, Karma west
Flat, pethidine, Zaleplon, maleic acid trimethylbenzene miaow piperazine, buprenorphine, Nalbuphine, methadone, Dilauid, hydrocodone
With one or more combination in morphine.
The preparation method of the antimicrobial coating of 15. Implantable Medical Device according to claim any one of 5-9, its feature exists
In the polymer is selected from polyglutamic acid, polylysine, poly-aspartate, polyethylene glycol, PLA, polycaprolactone, poly- second and hands over
One or more combination in ester and makrolon, or selected from one or more combination in the copolymer of these compounds.
The preparation method of the antimicrobial coating of 16. Implantable Medical Device according to claim any one of 5-9, its feature exists
In the solvent is selected from water, ethanol, methyl alcohol, tetrahydrofuran, hexafluoroisopropanol, trifluoroethanol, trifluoroacetic acid, dichloromethane, three
One or more combination in chloromethanes, dimethylformamide, ethyl acetate and acetone.
The preparation method of the antimicrobial coating of 17. Implantable Medical Devices according to claim 1, it is characterised in that described
In S2, the coating solution is sprayed at the implantable medical treatment by the way of electrostatic spraying, ultrasound spraying or aerial spraying
The surface of apparatus.
The preparation method of the antimicrobial coating of 18. Implantable Medical Devices according to claim 1, it is characterised in that described
The area of antimicrobial coating accounts for the 60%-90% of the Implantable Medical Device surface area, and the quality of the antimicrobial coating accounts for described
The 0.1%-0.8% of the Implantable Medical Device gross mass containing antimicrobial coating.
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| CN107648674A (en) * | 2017-09-29 | 2018-02-02 | 刘忠军 | With antibacterial and the metal implant for promoting Integrated implant function and preparation method thereof |
| CN107661544A (en) * | 2017-09-29 | 2018-02-06 | 北京大学第三医院 | Antibacterial facilitates porous orthopaedics implant of bone complex function and preparation method thereof |
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| CN111704856A (en) * | 2020-07-07 | 2020-09-25 | 南京工业大学 | Gamma-polyglutamic acid-polycation compound and preparation method and application thereof |
| CN113244436A (en) * | 2021-03-23 | 2021-08-13 | 安徽医科大学 | Chlorhexidine and catecholamine copolymerized antibacterial coating and preparation method and application thereof |
| CN113679943A (en) * | 2021-07-19 | 2021-11-23 | 伍亿良 | Processing equipment for antibacterial layer of implantable medical device |
| CN114452447A (en) * | 2021-08-03 | 2022-05-10 | 南京工业大学 | Mussel protein-polyamino acid coating and preparation method and application thereof |
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Application publication date: 20170623 |