CN103284771A - Antibacterial medical suture and production method thereof - Google Patents
Antibacterial medical suture and production method thereof Download PDFInfo
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- CN103284771A CN103284771A CN2013101914833A CN201310191483A CN103284771A CN 103284771 A CN103284771 A CN 103284771A CN 2013101914833 A CN2013101914833 A CN 2013101914833A CN 201310191483 A CN201310191483 A CN 201310191483A CN 103284771 A CN103284771 A CN 103284771A
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Abstract
The invention discloses an antibacterial medical suture and a production method thereof. A titanium-nickel memory alloy thread is adopted as a base material of the antibacterial medical suture. A silver-ion cladding layer with thickness of 0.1-1 micrometer is deposited on the surface of the base material. The production method includes depositing the silver-ion cladding layer on the base material in winding-type continuous coating equipment by a physical vapor deposition method. The antibacterial medical suture has functions of sterilization and bacteriostasis, and silver ions contact with positions of cuts, wounds and needle holes, so that infection prevention and resistance are realized; the antibacterial medical suture further keeps all properties of existing titanium-nickel memory alloy while having an antimicrobial property, is stable in chemical property, and can meet the requirements on stitching of infected wounds and seborrheic cuts; rejection is avoided during long-term in-vivo implantation, mechanical property is not changed, and the purposes of freeness of trauma, hyperplasia and in-vivo foreign matters are achieved.
Description
Technical field
The present invention relates to a kind of antimicrobial form suture and preparation method thereof.
Background technology
Common silk suture skin often stays obvious needle tracking in the incisxal edge both sides, even the abnormal pigmentary deposit on the skin trace, not only influence attractive in appearance, sometimes also with itching uncomfortable diseases such as acupuncture sample pain.For this reason, people have carried out many-sided exploration to sewing up skin material.
Use at present a kind of suture of the making by the ti-ni shape memory alloy silk on the hospital clinical, and at the sewing needle of sutural one or both ends connection with the different size shape of stainless steel material making, as cutting needle, curved round needle, straight round needle, spade pin etc., utilize the shape memory function of ti-ni shape memory alloy and the super-elasticity after the phase transformation, adopt the intradermic suture method to sew up, the wound butt joint is coincide, thereby satisfy intradermic suture clinically, subcuticular suture, tension suture, tendon is sewed up, patella is sewed up, the needs of operation such as breastbone stitching, and reach the effect that noinvasive is improved looks.The ti-ni shape memory alloy suture is freely deformable under room temperature and external force effect, but sew up the back under the body temperature environment, can recover original rectilinear form, relying on this elasticity strength that the skin of stitching is closed up mutually pastes, tightly involutory, form good healing condition, the compatibility is good more in a organized way with common silk thread, does not have antixenic advantage.But because ti-ni shape memory alloy suture and this series products do not possess anti-microbial property, thereby be restricted in the application clinically, have defective.
Though silver ion has broad spectrum antibacterial, but its plated film processing difficulties, because at ti-ni shape memory alloy stitching thread surface coating, primary prerequisite is after will guaranteeing plated film, still keep sutural shape memory and retention wire body to meet the sutural every physical property requirement of medical metal, otherwise it in a single day loses the memory of function or other physical properties change, and has just lost the meaning that clinical stitching is used.Therefore, adopt any coating process, should consider that all the physical property that whether influences base material changes, adopt electro-plating method plated film on ti-ni shape memory alloy stitching thread surface, have that cyanide etc. pollutes and harmful material residual.In addition, its temperature is generally 70～90 ℃ even higher, also has rete blocked up, influences the mechanical structure of ti-ni shape memory alloy silk, cause mechanical elasticity and human body temperature sensing to change, can cause the inner atomic series of silk thread to change and lose shape-memory properties or distortion; Adopt liquid-phase chemistry deposition technique (LPD), the certain toxicity of silver salt tool of generation, and skin histology had coloration; Chemical vapour deposition technique (CVD), its sedimentary deposit is generally columnar crystal structure, not anti-bending, frangibility; Adopt the nanometer silver coating, base material and adhesive force of coatings are low, come off easily, easily enter the blood of human body microcirculqtory system and cause unpredictable injury, and exist and cause risk that local silver-colored hemachromatosis and eye, respiratory tract injury do harm to etc.
At present, be base material with the ti-ni shape memory alloy silk, substrate surface deposits one deck silver ion coating, obtains new suture and does not appear in the newspapers as yet.
Summary of the invention
The object of the present invention is to provide a kind of antimicrobial form suture and preparation method thereof.
At the deficiencies in the prior art, the technical solution used in the present invention is:
A kind of antimicrobial form suture, it is base material with the ti-ni shape memory alloy silk, it is 0.1～1 μ m silver ion coating that substrate surface deposits a layer thickness.
Preferably, the diameter 0.10～0.5mm of ti-ni shape memory alloy silk.
Preferably, the phase transition temperature of ti-ni shape memory alloy silk is 33 ℃, and shape memory is straight line, tensile strength≤400Mpa, percentage elongation 〉=10%
Preferably, the phase transition temperature of antimicrobial form suture is 33 ℃, and shape memory is straight line, tensile strength≤400Mpa, percentage elongation 〉=10%.
The preparation method of above-mentioned antimicrobial form suture, be base material with the ti-ni shape memory alloy silk, adopt physical vaporous deposition at substrate surface depositing silver ion plating, may further comprise the steps: be base material with the ti-ni shape memory alloy silk, place the vacuum chamber of takeup type continuous coating device, with high-purity silver as target, carry out the cleaning of base material under the vacuum condition, dry under the vacuum condition, base material enters the plated film vacuum chamber, evacuation, wash target, feed the working gas argon, base material is carried out ion clean, adopt physical vaporous deposition that base material is carried out plated film, get the antimicrobial form suture.
In the preparation method of the present invention, the cleaning of base material and oven dry are all carried out under vacuum environment, with reduce to clean to greatest extent, baking temperature is to the influence of filament.And clean, dry link before the plating of traditional film plating process, all be under normal pressure, to carry out.
Preferably, the distance between base material and the target is controlled to be 60～180mm.
Preferably, physical vaporous deposition is any in direct current magnetron sputtering process, medium frequency magnetron sputtering method, thermal evaporation ion plating, the multi-arc ion coating.
Preferably, in the preparation process, the temperature of base material heated is controlled at 30～70 ℃.Preferably, the control of plated film time is at 1～3min.Preferred substrate heating temperature of the present invention and time, be the inside atomic structure sequence of avoiding the ti-ni shape memory alloy silk and destroyed.
Preferably, the takeup type continuous coating device comprises at least three base material chambers, and at least one cleans coating chamber.Common filming equipment is batch-plating equipment, and its vacuum chamber is single cavity, must be the short silk thread of metal of regular length with the severing of metal filament line at every turn, the single-unit silk thread is hung in the pivoted frame in the coating chamber by root again, and is with clip that the silk thread folder is steady.By the pivoted frame revolution, the anchor clamps rotation makes plated film face uniform deposition.Every batch of (every stove) plated film finishes, and is reentered into silk thread again, repeats next plated film flow process, and the method is single-unit formula batch-plating.Plated film efficient is extremely low, and process is cumbersome, and the manual operation process easily produces the line surface to be polluted, and the thickness of every batch (every stove) and glossiness etc. there are differences poor repeatability.The used technology of the present invention is the takeup type continuous coating device, comprises at least three base material chambers, and at least one cleans coating chamber; During work, a base material chamber and a cleaning coating chamber are in running status, another group then is resting state, when the base material of a certain cavity or target are finished using, take over standby cavity, make equipment remain circulation and run without interruption, thereby realize the tinsel of endless is carried out continuous coating, and realize obtaining at short notice rete even, fine and close, consistency of thickness with this.
Preferably, the deflection angle of the base material of the machine operation of base material coating process generation should be greater than 50 °.Deflection angle can be avoided the irreversibility flexural deformation of base material or cause the base material mechanical injuries greater than 50 °.
Preparation method of the present invention is the continuity hitless operation between each process procedure, to reduce artificial frequency of exposure the line surface is produced pollution; Should be soft materials with parts, tool that the line body directly contacts, avoiding that damage is caused in the line surface, thereby guarantee the uniformity and the line surface smoothness of plated film.
The antibacterial mechanisms of antimicrobial form suture of the present invention is the silver ion for sterilization principle:
Ag
+(silver ion) contacts with antibacterial based on the electro-adsorption principle.Because cell membrane has negative charge, and Ag
+Have positive charge, the two produces absorption and makes it strong bonded, and the activity of protozoa organized enzyme is reduced.Ag consequently
+Permeates cell membranes enters in the bacterial body, with the amino (– of the sulfur SH of bacterioprotein) produce chemical reaction: reaction causes protein coagulating, antibacterial is synthesized destroyed, and disturbs its DNA synthetic, makes its forfeiture division growth ability and death.Meanwhile, Ag
+Electric transmission system, respiratory system and the substance delivery system of antibacterial have also been destroyed with protein bound.In addition, Ag
+(+0.798ev, 25C), so antibacterial can dissociate again after being eliminated and disengage from thalline, and continues to produce oxidation reaction with other organic bacterial again, kill bacteria once again, this generation sterilization antibacterial action of Zhou Erfu to have higher oxidation-reduction potential.Thus, bactericidal effect is lasting and long-acting.
The invention has the beneficial effects as follows:
Suture of the present invention, surperficial silver ion coating possesses sterilization, bacteriostasis, contacts with otch, wound, pin hole position through silver ion, thereby reaches prevention infection and infection purpose; When possessing anti-microbial property, the various performances that also kept existing titanium nickel note shape alloy, medical stitching of the present invention can be satisfied the needs of infected wound and excessive fat myometrial suture, implant for a long time and do not have rejection, mechanical performance can not change, and reaches the purpose of not staying foreign body in no wound, no hypertrophy, the body.Suture of the present invention keeps the shape memory of ti-ni shape memory alloy silk, and meets the every physical property requirement of medical metal stitching thread of YY/0816-2010 pharmaceuticals industry standard code.
The present invention takes full advantage of the various characteristics of titanium nickeline memory alloy material, in conjunction with silver ion antibacterial surface function, the line body of the sewing needle by configuration different size shape and different-diameter, length, satisfy the needs that all kinds of clinical operations are sewed up comprehensively, can be widely used in segmentation clinical fields such as beauty treatment section, obstetrics, department of general surgery, orthopaedics, thoracic surgery, the technology of the present invention is for the prevention of postoperative wound infection, sense of acceleration metachromia wound healing, reducing the antibiotic application to greatest extent and have positive clinical meaning, is a kind of very good functional type bio-medical suture instruments product.
The specific embodiment
Antimicrobial form suture of the present invention is base material with the ti-ni shape memory alloy silk, adopts direct current magnetron sputtering process at substrate surface depositing silver ion plating, and its preparation method may further comprise the steps:
1) base material is prepared:
The ti-ni shape memory alloy silk that selection has made, alloy filament diameter 0.10～0.5mm, phase transition temperature is 33 ℃, shape memory is straight line, and is wrapped on the rustless steel spool, and the medical alloy silk meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, number of torsions is 10), tinsel should not fracture, the surface visual visible crack that do not have; Mechanical performance: tensile strength≤400Mpa, percentage elongation 〉=10%;
2) target is prepared:
Selecting the solid-state silver of high-purity (99.99%) is target; Target is to spatter target structure in the hollow cylinder, and base material, magnetic controlled sputtering target are ready, carries out magnetically controlled DC sputtering and handles;
3) clean before the plated film:
Silk thread on the base material axle volume enters the ultrasonic vacuum chamber of the continuous magnetically controlled DC sputtering equipment of takeup type, successively through oil removing, except cured, cross clear water, cross pure water and clean, to remove the substrate surface spot; Water temperature is regulated 35～65 ℃, ultrasound wave frequency 20kHz～30kHz, vacuum 5.0Pa;
4) baking the affected part after applying some drugs dry-cure:
Base material enters the heated drying vacuum chamber, thermoregulation to 40～50 ℃;
5) evacuation:
Base material enters the plated film vacuum chamber, according to the coating film thickness requirement, makes vacuum reach 5.0 * 10
-3Pa, the distance between base material and the target is controlled to be 60～180mm, with the memory elasticity of avoiding target temperature effect base material or cause distortion;
6) wash target (also claiming the some target):
Reach 7.0 * 10 in vacuum
-3～5.0 * 10
-3Open target during Pa, target surface is carried out clean, with the gas of removing target absorption and the coating that cleans the target surface;
7) ion cleans:
Feed the argon of higher pressure, room pressure remains on 2～3pa, simultaneously base material is applied back bias voltage 800～1200V, base material is carried out ion clean 10～15min; Caused glow discharge after applying back bias voltage, by the Ar ion of ionization under effect of electric field, high-octane bombarding base material, thus the dirty of substrate surface and surface oxide layer sputter are gone out;
8) spatter film forming:
Continue to feed argon, room pressure reaches 5.0 * 10
-1During Pa, open target, adjust target voltage: 400～500V; Target power output: 10～30W/cm
2Pulsed bias: 300～400V; Dutycycle 20%; Plated film time: 1～3min finally obtains desired thin film;
9) cooling:
Plated film finishes, and closes target power supply, grid bias power supply, powered-down then, and workpiece injects atmosphere at the coating chamber internal cooling to coating chamber, takes out silver-plated ti-ni shape memory alloy silk.
Antimicrobial form suture of the present invention is base material with the ti-ni shape memory alloy silk, adopts the medium frequency magnetron sputtering method at substrate surface depositing silver ion plating, and its preparation method may further comprise the steps:
1) base material is prepared:
The ti-ni shape memory alloy silk that selection has made, alloy filament diameter 0.10～0.5mm, phase transition temperature is 33 ℃, shape memory is straight line, and is wrapped on the rustless steel spool; The medical alloy silk meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel should not fracture, the surface visual visible crack that do not have; Mechanical performance: tensile strength≤400Mpa, percentage elongation 〉=10%;
2) target is prepared:
Selecting the solid-state silver of high-purity (99.99%) is target; Adopt plane magnetic control to target structure, twin target connects the both positive and negative polarity of intermediate frequency power supply respectively, and base material, magnetic controlled sputtering target are ready, carry out medium frequency magnetron sputtering and handle;
3) clean before the plated film:
Silk thread on base material axle volume enters the ultrasonic vacuum chamber of the continuous medium frequency magnetron sputtering equipment of takeup type, successively through oil removing, except cured, cross clear water, cross pure water and clean, to remove the substrate surface spot; Water temperature is regulated 35～65 ℃, ultrasound wave frequency 20kHz～30kHz, vacuum 5.0Pa;
4) baking the affected part after applying some drugs dry-cure:
Base material enters the heated drying vacuum chamber, thermoregulation to 40～50 ℃;
5) evacuation:
Base material enters the plated film vacuum chamber, according to the coating film thickness requirement, makes vacuum reach 5.0 * 10
-3Pa, the distance between base material and the target is controlled to be 60～180mm, to avoid the target temperature not influence the memory elasticity of base material or to cause distortion;
6) wash target (also claiming the some target):
Reach 7.0 * 10 in vacuum
-3～5.0 * 10
-3Open target during Pa, target surface is carried out clean, with the gas of removing target absorption and the coating that cleans the target surface;
7) ion cleans:
Feed the argon of higher pressure, room pressure remains on 2～3pa, simultaneously base material is applied back bias voltage 800～1200V, base material is carried out ion clean 10～15min; Caused glow discharge after applying back bias voltage, by the Ar ion of ionization under effect of electric field, high-octane bombarding base material, thus the dirty of substrate surface and surface oxide layer sputter are gone out;
8) spatter film forming:
Continue to feed argon, room pressure reaches 5.0 * 10
-1During Pa, open target, adjust target voltage: 400～500V; Target power output: 10～30W/cm
2Pulsed bias: 300～400V; Dutycycle 25%; Plated film time: 1～3min finally obtains desired thin film;
9) cooling:
Plated film finishes, and closes target power supply, grid bias power supply, powered-down then, and workpiece injects atmosphere at the coating chamber internal cooling to coating chamber, takes out silver-plated ti-ni shape memory alloy silk.
Antimicrobial form suture of the present invention is base material with the ti-ni shape memory alloy silk, adopts the thermal evaporation ion plating method at substrate surface depositing silver ion plating, and its preparation method may further comprise the steps:
1) base material is prepared:
The ti-ni shape memory alloy silk that selection has made, alloy filament diameter 0.10～0.5mm, phase transition temperature is 33 ℃, shape memory is straight line, and is wrapped on the rustless steel spool; The medical alloy silk meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel should not fracture, the surface visual visible crack that do not have; Mechanical performance: tensile strength≤400Mpa, percentage elongation 〉=10%;
2) target is prepared:
Selecting the solid-state silver of high-purity (99.99%) is target; Target is coiled for the wire argent; Base material, wire target are ready, carry out the thermal evaporation ion film plating and handle;
3) clean before the plated film:
Silk thread on base material axle volume enters the ultrasonic vacuum chamber of takeup type Continuous Heat evaporated ions coating apparatus, successively through oil removing, except cured, cross clear water, cross pure water and clean, to remove the substrate surface spot; Water temperature is regulated 35～65 ℃, ultrasound wave frequency 20kHz～30kHz, vacuum 5.0Pa;
4) baking the affected part after applying some drugs dry-cure:
Base material enters the heated drying vacuum chamber, thermoregulation to 40～50 ℃;
5) evacuation:
Base material enters the plated film vacuum chamber, according to the coating film thickness requirement, makes vacuum reach 5.0 * 10
-3Pa, the distance between base material and the target is controlled to be 60～180mm, with the memory elasticity of avoiding target temperature effect base material or cause distortion;
6) wash target (also claiming the some target):
Reach 7.0 * 10 in vacuum
-3～5.0 * 10
-3Open target during Pa, target surface is carried out clean, with the gas of removing target absorption and the coating that cleans the target surface;
7) ion cleans:
Feed the argon of higher pressure, room pressure remains on 2～3pa, simultaneously base material is applied back bias voltage 800～1200V, base material is carried out ion clean 10～15min; Caused glow discharge after applying back bias voltage, by the Ar ion of ionization under effect of electric field, high-octane bombarding base material, thus the dirty of substrate surface and surface oxide layer sputter are gone out;
8) evaporation film-forming:
Room pressure reaches 5.0 * 10
-4During Pa, open target, adjust target voltage: 18～20V; Pulsed bias: 300～400V; Dutycycle 80～20%; Plated film time: 1～3min finally obtains desired thin film;
9) cooling:
Plated film finishes, and closes target power supply, grid bias power supply, powered-down then, and stall frame, workpiece inject atmosphere at the coating chamber internal cooling to coating chamber, take out silver-plated ti-ni shape memory alloy silk.
Antimicrobial form suture of the present invention is base material with the ti-ni shape memory alloy silk, adopts the multi-arc ion coating method at substrate surface depositing silver ion plating, and its preparation method may further comprise the steps:
1) base material is prepared:
The ti-ni shape memory alloy silk that selection has made, alloy filament diameter 0.10～0.5mm, phase transition temperature is 33 ℃, shape memory is straight line, and is wrapped on the rustless steel spool; The medical alloy silk meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel should not fracture, the surface visual visible crack that do not have; Mechanical performance: tensile strength≤400Mpa, percentage elongation 〉=10%;
2) target is prepared:
Selecting the solid-state silver of high-purity (99.99%) is target; Target is plating target structure in the hollow cylinder, and base material, multiple arc target are ready, carry out multi-arc ion plating film and handle;
3) clean before the plated film:
Silk thread on base material axle volume enters the ultrasonic vacuum chamber of the continuous multi-arc ion plating equipment of takeup type, successively through oil removing, except cured, cross clear water, cross pure water and clean, to remove the substrate surface spot; Water temperature is regulated 35～65 ℃, ultrasound wave frequency 20kHz～30kHz, vacuum 5.0Pa;
4) baking the affected part after applying some drugs dry-cure:
Base material enters the heated drying vacuum chamber, thermoregulation to 40～50 ℃;
5) evacuation:
Base material enters the plated film vacuum chamber, according to the coating film thickness requirement, makes vacuum reach 5.0 * 10
-3Pa, the distance between base material and the target is controlled to be 60～180mm, with the memory elasticity of avoiding target temperature effect base material or cause distortion;
6) wash target (also claiming the some target):
Reach 7.0 * 10 in vacuum
-3～5.0 * 10
-3Open target during Pa, target surface is carried out clean, with the gas of removing target absorption and the coating that cleans the target surface;
7) ion cleans:
Feed the argon of higher pressure, room pressure remains on 2～3pa, simultaneously base material is applied back bias voltage 800～1200V, base material is carried out ion clean 10～15min; Caused glow discharge after applying back bias voltage, by the Ar ion of ionization under effect of electric field, high-octane bombarding base material, thus the dirty of substrate surface and surface oxide layer sputter are gone out;
8) electric arc evaporation film-forming:
Room pressure reaches 5.0 * 10
-4During Pa, open target, adjust target voltage: 18～20V; Pulsed bias: 300～400V; Dutycycle 80～20%; Plated film time: 1～3min finally obtains desired thin film;
9) cooling:
Plated film finishes, and closes target power supply, grid bias power supply, powered-down then, and workpiece injects atmosphere at the coating chamber internal cooling to coating chamber, takes out silver-plated ti-ni shape memory alloy silk.
The present invention is further illustrated below in conjunction with specific embodiment, but be not limited thereto.
Embodiment 1
A kind of antimicrobial form suture is base material with the ti-ni shape memory alloy silk, adopts direct current magnetron sputtering process at substrate surface depositing silver ion plating, its preparation method:
Select the ti-ni shape memory alloy silk as base material, line body diameter 0.2 ± 0.01 mm, phase transition temperature is 33 ℃, shape memory is straight line, mechanical performance meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test, tinsel should not fracture, the surface visual visible crack that do not have; Tensile strength 375Mpa, percentage elongation 19%.
Behind the substrate surface greasiness removal, place the vacuum chamber of the continuous magnetically controlled DC sputtering equipment of takeup type, with high-purity silver as sputtering target material, adopt in the hollow cylinder and spatter target structure, evacuation, the distance between base material and the target is controlled to be 60mm, washes target, feed the working gas argon, room pressure remains on 2.5pa, simultaneously base material is applied back bias voltage 1000V, base material is carried out ion clean 10min, continue to feed argon, room pressure reaches 5.0 * 10
-1Pa opens target, and the adjustment target voltage is 450V, and target power output is 20W/cm
2, pulsed bias is 350V, dutycycle 20% is carried out sputter coating 2min to base material, gets the antimicrobial form suture.
After the experiment, gained antimicrobial form suture, its performance is as follows: silver ion thickness of coating 0.25 ± 0.01 μ m, the smooth densification of line surface plated film, through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel does not fracture, surperficial visual flawless; Tensile strength 373Mpa, percentage elongation 23%; Phase transition temperature and straight line shape memory do not change.
Embodiment 2
A kind of antimicrobial form suture is base material with the ti-ni shape memory alloy silk, adopts the medium frequency magnetron sputtering method at substrate surface depositing silver ion plating, its preparation method:
Select the ti-ni shape memory alloy silk as base material, line body diameter 0.15mm ± 0.01, substrate performance: the base material phase transition temperature is 33 ℃, shape memory is straight line.Mechanical performance meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test, tinsel should not fracture, the surface visual visible crack that do not have; Tensile strength 385Mpa, percentage elongation 15%.
Behind the substrate surface greasiness removal, place the vacuum chamber of the continuous medium frequency magnetron sputtering equipment of takeup type, with high-purity silver as sputtering target material, adopt plane magnetic control to target structure, evacuation, the distance between base material and the target is controlled to be 80mm, washes target, feed the working gas argon, room pressure remains on 2pa, simultaneously base material is applied back bias voltage 1100V, base material is carried out ion clean 12min, continue to feed argon, room pressure reaches 5.0 * 10
-1Pa opens target, and the adjustment target voltage is 450V, and target power output is 10W/cm
2, pulsed bias is 300V, dutycycle 25% is carried out sputter coating 2min to base material, gets the antimicrobial form suture.
After the experiment, gained antimicrobial form suture, its performance is as follows: silver ion thickness of coating 0.25 ± 0.01 μ m, the smooth densification of line surface plated film.Through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel does not fracture, surperficial visual flawless; Tensile strength 385Mpa, percentage elongation 19%; Phase transition temperature and straight line shape memory do not change.
Embodiment 3
A kind of antimicrobial form suture is base material with the ti-ni shape memory alloy silk, adopts the thermal evaporation ion plating method at substrate surface depositing silver ion plating, its preparation method:
Select the ti-ni shape memory alloy silk as base material, line body diameter 0.2mm ± 0.02, substrate performance: the base material phase transition temperature is 33 ℃, shape memory is straight line, mechanical performance meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test, tinsel should not fracture, the surface visual visible crack that do not have; Tensile strength 365Mpa, percentage elongation 23%.
Behind the substrate surface greasiness removal, place the vacuum chamber of takeup type Continuous Heat evaporated ions coating apparatus, as target, adopt wire target (the wire argent is coiled), evacuation with high-purity silver, distance between base material and the target is controlled to be 160mm, wash target, room pressure remains on 3pa, simultaneously base material is applied back bias voltage 800V, base material is carried out ion clean 15min, room pressure reaches 5.0 * 10
-4Pa opens target, and the adjustment target voltage is 18V, and pulsed bias is 400V, and dutycycle 40% is carried out sputter coating 2min to base material, gets the antimicrobial form suture.
After the experiment, gained antimicrobial form suture, its performance is as follows: silver ion thickness of coating 0.25 ± 0.01 μ m, the smooth densification of line surface plated film.Through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel does not fracture, surperficial visual flawless; Tensile strength 385Mpa, percentage elongation 27%; Phase transition temperature and straight line shape memory do not change.
Embodiment 4
A kind of antimicrobial form suture is base material with the ti-ni shape memory alloy silk, adopts the multi-arc ion coating method at substrate surface depositing silver ion plating, its preparation method:
Select the ti-ni shape memory alloy silk as base material, line body diameter 0.25mm ± 0.02, substrate performance: the base material phase transition temperature is 33 ℃, shape memory is straight line.Mechanical performance meets the standard code of YY/0816-2010 pharmaceuticals industry: through alternating bending test and torsion test, tinsel should not fracture, the surface visual visible crack that do not have; Tensile strength 355Mpa, percentage elongation 26%.
Behind the substrate surface greasiness removal, place the vacuum chamber of the continuous multi-arc ion plating equipment of takeup type, as target, adopt plating target in the hollow cylinder with high-purity silver.Evacuation, the distance between base material and the target is controlled to be 180mm, washes target, and room pressure remains on 2.5pa, simultaneously base material is applied back bias voltage 1000V, base material is carried out ion clean 15min, and room pressure reaches 5.0 * 10
-4Pa opens target, and the adjustment target voltage is 20V, and pulsed bias is 400V, and dutycycle 55% is carried out sputter coating 3min to base material, gets the antimicrobial form suture.
After the experiment, gained antimicrobial form suture, its performance is as follows: silver ion thickness of coating 0.30 ± 0.01 μ m, the smooth densification of line surface plated film, through alternating bending test and torsion test (from 40 ° of the deflection angles of zero-bit, number of bends is 20, and number of torsions is 10), tinsel does not fracture, surperficial visual flawless; Tensile strength 385Mpa, percentage elongation 31%; Phase transition temperature and straight line shape memory do not change.
Antimicrobial form suture of the present invention has following characteristic:
1, compares with the ti-ni shape memory alloy stitching thread: the tool antibacterial functions.Because infected wound, overflow the fat otch all in various degree influence sewing effect.Silver ion coating can effectively suppress pathogenic bacterium growth, prevention of postoperative wound infection, accelerating wound healing; Simultaneously, possesses good anti-infectious function for infected wound.
2, compare with all kinds of non-absorption lines, absorbable suture: the equal memoryless function of this series products at present.The shape memory effect of present technique tool uniqueness and super-elasticity dual-use function satisfy the clinical demand of mechanical function, chemistry and biology simultaneously.Produce powerful restoring force in the recovery of shape process in vivo, produce super-elasticity, thereby use both sides skin tightly to be docking together, behind the wound healing line is removed, do not stay any foreign body in the body.The intensity height, in the tension suture application facet, more obvious traditional non-absorption line, the absorbable suture series products of being better than.
3, titanium nickeline memorial alloy stitching thread has excellent biological compatibility, does not in use have the reaction of stitching, does not adsorb tissue fluid, dye-free, fibre-less.The line body can be set different phase transition temperatures according to clinical needs, satisfies different clinical operation needs to adjust mechanicalness.
4, stable chemical performance can satisfy the needs of infected wound and excessive fat myometrial suture, implants for a long time and does not have rejection, and mechanical performance can not change.
Claims (10)
1. antimicrobial form suture, it is characterized in that: it is base material with the ti-ni shape memory alloy silk, it is 0.1～1 μ m silver ion coating that substrate surface deposits a layer thickness.
2. antimicrobial form suture according to claim 1 is characterized in that: the diameter 0.10～0.5mm of ti-ni shape memory alloy silk.
3. antimicrobial form suture according to claim 1 and 2, it is characterized in that: the phase transition temperature of ti-ni shape memory alloy silk is 33 ℃, shape memory is straight line, tensile strength≤400Mpa, percentage elongation 〉=10%.
4. antimicrobial form suture according to claim 1 and 2, it is characterized in that: the phase transition temperature of antimicrobial form suture is 33 ℃, shape memory is straight line, tensile strength≤400Mpa, percentage elongation 〉=10%.
5. the preparation method of each described antimicrobial form suture of claim 1～4 may further comprise the steps: be base material with the ti-ni shape memory alloy silk, place the vacuum chamber of takeup type continuous coating device, with silver as target, carry out the cleaning of base material under the vacuum condition, dry under the vacuum condition, base material enters the plated film vacuum chamber, evacuation, wash target, feed the working gas argon, base material is carried out ion clean, adopt physical vaporous deposition that base material is carried out plated film, get the antimicrobial form suture.
6. preparation method according to claim 5, it is characterized in that: the distance between base material and the target is controlled to be 60～180mm.
7. preparation method according to claim 5, it is characterized in that: physical vaporous deposition is any in direct current magnetron sputtering process, medium frequency magnetron sputtering method, thermal evaporation ion plating, the multi-arc ion coating.
8. preparation method according to claim 5, it is characterized in that: in the preparation process, the temperature of base material heated is controlled at 30～70 ℃.
9. preparation method according to claim 5, it is characterized in that: the plated film time is controlled at 1～3min.
10. preparation method according to claim 5, it is characterized in that: the takeup type continuous coating device comprises at least three base material chambers, at least one cleans coating chamber.
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Effective date of registration: 20160308 Address after: 519000 Guangdong city of Zhuhai province Gongbei Changping Summer Bay Road No. 251 building six floor B Patentee after: ZHUHAI TUOAI MEDICAL TECHNOLOGY CO., LTD. Address before: 504, building 12, building 101, 519000, national defense Road, Xiangzhou, Zhuhai, Guangdong, Gongbei Patentee before: Han Yongjun Patentee before: Jing Xiangyang |