CN103948973B - A kind of medical endotracheal tube with safe and efficient anti-microbial property - Google Patents

A kind of medical endotracheal tube with safe and efficient anti-microbial property Download PDF

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CN103948973B
CN103948973B CN201410160736.5A CN201410160736A CN103948973B CN 103948973 B CN103948973 B CN 103948973B CN 201410160736 A CN201410160736 A CN 201410160736A CN 103948973 B CN103948973 B CN 103948973B
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trachea cannula
organosilicon
mtes
teos
cannula conduit
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CN103948973A (en
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蒋旭宏
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Abstract

The invention discloses a kind of medical endotracheal tube with safe and efficient anti-microbial property, with ethyl orthosilicate (TEOS) for silicon source, with gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) for organic facies presoma, take inorganic nano-silver as antibacterial, through sol-gel method, take trachea cannula conduit as base material again, carry out antibacterial surface coating, be prepared from organosilicon Ag-carried antibacterial coating trachea cannula conduit.Organosilicon Ag-carried antibacterial coating trachea cannula conduit of the present invention can reduce the infections relating complication in endotracheal tube indwelling process, the state of an illness of patient can be alleviated, elongate catheter indwelling time, for the quality time is won in the successful treatment of Cavity in Critical Patients, alleviate medical economy burden, Operative risk and patient's body and mind to torment simultaneously, thus improve intubation prognosis of disease.

Description

A kind of medical endotracheal tube with safe and efficient anti-microbial property
Technical field
This patent relates to medical field, specifically must say, is a kind of organosilicon Ag-carried antibacterial coating Medical trachea cannula conduit.
Background technology
Tracheal intubation sets up the simple and direct effective method of unobstructed air flue during critical patients rescues.Except patients undergoing general anesthesia, in the rescue process of many critical patients, in order to effectively carry out mechanical ventilation, remove tracheal strips sputum or blood, anti-anti-nausea is suffocated, and removes respiratory tract obstruction, often need carry out tracheal intubation.The artificial airway that tracheal intubation is set up, becomes patient most important " life line ".Patient is once implement tracheal intubation, and endotracheal tube indwelling time is generally: oral trachea cannula is generally no more than 72 hours; Generally be no more than 1 week through nasal intubation, time lengthening is very easy to cause intubate complication.Because the endotracheal tube of current Clinical practice is made primarily of medical polyvinyl (PVC), conduit has adhesiveness to airway secretions, after intubate airway mucus oppress, rub, stimulation etc., causing that mucosa injury is even carcinogenic may.And easily causing respiratory tract infection after MV via intubation 48h---Ventilator Associated Pneumonia, this also becomes complication common and the most serious in mechanical ventilation, and sickness rate, case fatality rate are high, and therapeutic effect is poor, and medical resource consumption is large.The measure taked at present is actively anti-infective therapy, air flue humidification, effective nursing etc. mainly, but does not well reduce the generation of Ventilator Associated Pneumonia [1]; American Thoracic Society (ATS) and infectious disease association of the U.S. (IDSA) combine the research of evidence based clinical practice guidelines (EBPG) having formulated VAP [2], suggestion adopts semireclining position, reduces tranquilizer use, prevents peptic ulcer to occur, strengthens mouth care, strengthens the measure such as medical worker's hand hygiene and strict aseptic technique, prevents the generation of VAP.But the preventive and therapeutic effect that these measures insert to trachea cannula conduit bacterial growth and the drug resistance generation caused is less.The respiratory tract infection caused because of tracheal intubation and the common pathogen of Ventilator Associated Pneumonia are Pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, Acinetobacter bauamnnii, Klebsiella Pneumoniae etc. [3], and these antibacterials can in succession or overlapping to occur in intubation, show the even general drug resistance of multidrug resistant [4].Particularly Pseudomonas aeruginosa is as easy as rolling off a log sticks to tracheal intubation surface, and secrete polysaccharide matrix, fibrin, lipoprotein etc. and make the inter-adhesive gathering of antibacterial, just biofilm can be formed on surface after several hours in tracheal intubation indwelling, antibiotic is difficult to penetrate into biofilm, cause the multidrug resistant generation of antibacterial, and field planting, at patient airway, becomes the antibacterial that nosocomial infection is the most thorny thereupon [5].Clinical practice antibiosis usually prevents and treats Ventilator Associated Pneumonia, but because of general drug resistance and the multidrug resistant of antibacterial, curative effect is caused anxiety, and patient is usually owing to effectively cannot control respiratory tract infection and dead, and the antimicrobial drug of development of new antimicrobial agent is overnight non- [6].The generation of the complication of tracheal intubation particularly Ventilator Associated Pneumonia, the prognosis of direct relation patient disease, once occur again less than effective control, patient will have to face and pull out endotracheal tube, again intubate or tracheotomy, considerably increase medical economy burden, patient treatment risk and body and mind and torment.Therefore, reduce or delay the generation of tracheal intubation Ventilator Associated Pneumonia, with regard to energy elongate catheter indwelling time, strive for the quality time for patient rescues, improve treatment success rate, also can reduce medical economy burden, alleviate the body and mind of patient misery.At present, sight focuses in the antibacterial surface modification of trachea cannula conduit by Chinese scholars, does not change original conduit profile and makes it obtain anti-microbial property, reduces bacterial growth, prevents and treats Ventilator Associated Pneumonia with this.Pacheco-FowlerV etc. [7]silver ion and CHLORHEXIDINE complex is adopted to have developed antibiotic coating trachea cannula conduit, carry out zoopery and find that the infection rate of the more common trachea cannula conduit of antibacterial trachea cannula conduit obviously reduces, but fail effectively to prevent the precipitation of silver ion, thus do not use at clinical expansion.RaadII etc. [8]use silver compound development coating trachea cannula conduit and observe its antibacterial curative effect, found that silver compound coating trachea cannula conduit can reduce the risk of Ventilator Associated Pneumonia, but antibacterial action is limited, and the adhesiveness of catheter surface to airway secretions can not be reduced, easily cause the expectorant bolt of tracheal intubation to block.Berra etc. [9]research and development silver sulfadiazine-compound polyurethane material trachea cannula conduit, carries out zoopery and finds effectively to grow and field planting at respiratory tract by anti-bacteria, but have the risk increasing bacterial drug resistance.Kollef etc. [10]have developed the trachea cannula conduit of silver ion coating, and random, single blind prospective control study has been carried out in 54 research centers in North America, found that the trachea cannula conduit of silver ion coating obviously can reduce and postpone the generation of VAP, but the toleration of opposed pipe, the occupancy rate of ICU, hospital stays, mortality rate etc. be impact no, and silver ion precipitation also fails effectively to prevent, and there is obvious side reaction.Because these antibacterial trachea cannula conduits newly developed are owing to existing the risk of biological untoward reaction or increase bacterial drug resistance, so fail to use at clinical expansion.The trachea cannula conduit of the high-efficiency antimicrobial performance of our development changes the material of antimicrobial coating in the past, overcome the deficiency of the antibacterial endotracheal tube in the past developed, not only there is efficient antibiotic property, and coating silver ion is separated out hardly, smooth surface does not adhere to sputum, the advantages such as side reaction is extremely low, meet the needs of clinical tracheal intubation, can provide the trachea cannula conduit with safe and efficient anti-microbial property for clinical.
List of references
1.
Yan Ruina, Huang Xiangzeng. Ventilator Associated Pneumonia preventative strategies can [J]. Chinese practical diagnosis and treatment magazine, 2011,25 (2): 105-107.
2.American Thoracic Society,Infectious Diseases Society of America.Guidelinesfor the management of adults with hospital-acquired,ventilator-associated,andhealthcare-associated pneumonia[J].Am J Respir Crit Care Med,2005,171(4):388-416.
3. week is fine, and 65, the .2009-2010 Shanghai City such as Hu Bijie, Gao Xiaodong hospital ICU catheter associated infection Target Monitoring analyzes [J]. Chinese Journal of Nosocomiology, 2011,21 (12): 2408-2410.
4.Hong H,Landauer M R,Foriska M A,et al.Antibacterial activity of the soyisoflavone genistein[J].Basic Microbiol,2006,46(4):329-335.
5. a Yi is won, Ni Yuxing, Sun Jingyong etc.
Within 2010, Chinese CHINET Antimicrobial Resistance of Pseudomonas Aeruginosa detects [J]. and China infects and chemotherapy magazine, and 2012,12 (3): 161-166.
6.Ament P W,Jamshed N,Horne J P.Linezo-lid:its role in the treatment of Gram-positive,drug-resistant bacterial infections[J].Am Fam Physician,2002,65(4):663-671.
7.Pacheco-Fowler V;Gaonkar T;Wyer PC,et al.Antiseptic impregnatedendotracheal tubes for the prevention of bacterial colonization[J].J Hosp Infect.2004Jun;57(2):170-174.
8.Raad II,Mohamed JA,Reitzel RA,et al.The prevention of biofilm colonizationby multidrug-resistant pathogens that cause ventilator-associated pneumonia withantimicrobial-coated endotracheal tubes[J].Biomaterials.2011,32(11):2689-2694.
9.Berra L,Kolobow T,Laquerriere P,etal.Internally coated endotracheal tubes withsilver sulfadiazine in polyurethane to prevent bacterial colonization:a clinical trial[J].Intensive Care Med,2008,34(6):1030-1037.
10.Kollef MH,Afessa B,Anzueto A,et al.Silver-coated endotracheal tubes andincidence of ventilator-associated pneumonia the NASCENT randomized trial[J].JAMA,2008,300(7):805-813.
Summary of the invention
This patent is just in order to overcome the weak point of the antibacterial trachea cannula conduit existence of the PVC trachea cannula conduit of existing Clinical practice and development at present, there is provided one can reduce tracheal intubation and insert postoperative infection complication, there is not biological untoward reaction again, be applicable to the trachea cannula conduit of the organosilicon Ag-carried antibacterial coating that human body uses.
The concrete technical scheme of this patent is as follows:
The invention discloses a kind of medical endotracheal tube with safe and efficient anti-microbial property, with ethyl orthosilicate (TEOS) for silicon source, with γ-
Methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) are organic facies presoma, be antibacterial, through sol-gel method, prepare TEOS/KH570/MTES/Ag-with inorganic nano-silver
SiO 2the organosilicon Ag-carried antibacterial colloidal sol of quaternary system; Take trachea cannula conduit as base material again, carry out antibacterial surface coating, be prepared from organosilicon Ag-carried antibacterial coating trachea cannula conduit.
As further improvement, trachea cannula conduit of the present invention take PVC as base material.
Have a preparation method for the endotracheal tube of safe and efficient anti-microbial property, concrete preparation process is as follows:
(1), with ethyl orthosilicate (TEOS) for silicon source, with gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) for organic facies presoma, take inorganic nano-silver as antibacterial, be there is by the preparation of sol-gel technology room temperature the TEOS/KH570/MTES organic silicon sol of multifunctional molecule level compound;
(2), by hydrolytic crosslinking, mechanical mix techniques, by high speed shear effect, inorganic nano silver antibacterial agent is added in prefabricated TEOS/KH570/MTES organic silicon sol, make silver antibacterial agent can be uniformly dispersed in organosilicon complex sol, prepared the TEOS/KH570/MTES/Ag-SiO of clear by chemical bonding and physisorption 2the organosilicon Ag-carried antibacterial modification sol of quaternary system;
(3), by trachea cannula conduit surface activation process: by washing with alcohol, remove catheter surface impurity, after drying, sided corona treatment, high-frequency high-voltage is utilized to produce low temperature plasma at trachea cannula conduit corona discharge, these gas ions destroy its molecular structure by shocking by electricity and penetrating into PVC surface, and then by the oxidation of processed surface molecular and polarization, produce the free radicals such as-O-O-,-OH, increase surface roughness simultaneously, reduce surface energy, improve surface adhesion force, realize PVC base surface active;
(4) the trachea cannula conduit surface, by Dipcoat method organosilicon Ag-carried antibacterial modification sol being coated surface active is prepared conduit and to be wet dissolved glue film, adopts heat curing process, obtains the TEOS/KH570/MTES/Ag-SiO with excellent antibacterial performance 2organosilicon Ag-carried antibacterial coating trachea cannula conduit.
As improving further, in step of the present invention (1), the concrete preparation process of organosilicon complex sol is: first by TEOS, dehydrated alcohol and deionized water mix homogeneously under magnetic stirring apparatus, add acetic acid, TEOS is hydrolyzed reaction, obtain silicon dioxide gel, add KH570 and MTES mixed solution again, continue stirring and to be hydrolyzed condensation reaction, obtain organosilicon complex sol;
As improving further, in step of the present invention (1), the ratio of described TEOS/KH570/MTES is (14 ~ 16)/(5 ~ 7)/(1 ~ 3).
As improving further, Si-OH, R1-COO-R, Si-O-Si group that organic silicon sol of the present invention contains can show good film property, Si-CH 3,-CH 3coating surface energy can be reduced, thus prevent proteinaceous tissue cell adhesion.
As improving further, in step of the present invention (2), the concentration of inorganic nano silver antibacterial agent is 0.8% ~ 1.3%.
As improving further, step of the present invention (3) medium-high frequency high voltage is 5000-15000V/m 2.
As improving further, adopting in step of the present invention (4) heat curing process to refer to and processing 30 ~ 60 minutes at 80 ~ 100 DEG C of temperature.
As improving further, the TEOS/KH570/MTES/Ag-SiO with excellent antibacterial performance described in step of the present invention (4) 2the coating layer thickness of organosilicon Ag-carried antibacterial coating trachea cannula conduit is at 200 ~ 400nm.
Advantageous Effects of the present invention is as follows:
Organosilicon Ag-carried antibacterial coating trachea cannula conduit of the present invention can reduce the infections relating complication in endotracheal tube indwelling process, the state of an illness of patient can be alleviated, elongate catheter indwelling time, for the quality time is won in the successful treatment of Cavity in Critical Patients, alleviate medical economy burden, Operative risk and patient's body and mind to torment simultaneously, thus improve intubation prognosis of disease.
In addition, we make primarily of PVC by the trachea cannula conduit of Clinical practice, antibacterial easily adheres to growth and forms that biofilm makes infection be difficult to control, PVC material easily causes the untoward reaction such as sputum adhesion, oral cavity airway mucus damage, and generate business abroad to this conduit there is monopoly position, domestic production enterprise does not still have autonomous patent right, needs clinical middle every day the patient carrying out MV via intubation countless.Our the patent finished product organosilicon of research carries silver coating PVC trachea cannula conduit; base oneself upon the reality need of clinical tracheal intubation; there is high-efficiency antimicrobial performance; and inanimate object untoward reaction; the productivity can be changed into from scientific research very soon; once the rejuvenation and development for China's medicinal career clinically contributes by large-scale production being applied to, there is important learning value and very high social economic value, have a extensive future.
Accompanying drawing explanation
Fig. 1 is TEOS/KH570/MTES/Ag-SiO 2the preparation flow schematic block diagram of the organosilicon Ag-carried antibacterial colloidal sol of quaternary system;
Fig. 2 be embodiment 1 under scanning electron microscope (SEM) by catheter surface TEOS/KH570/MTES/Ag-SiO 2organosilicon Ag-carried antibacterial coating amplifies the pattern schematic diagram of 5000 times;
Fig. 3 be embodiment 2 under scanning electron microscope (SEM) by catheter surface TEOS/KH570/MTES/Ag-SiO 2organosilicon Ag-carried antibacterial coating amplifies the pattern schematic diagram of 5000 times;
Fig. 4 be embodiment 3 under scanning electron microscope (SEM) by catheter surface TEOS/KH570/MTES/Ag-SiO 2organosilicon Ag-carried antibacterial coating amplifies the pattern schematic diagram of 5000 times.
Detailed description of the invention
The invention discloses a kind of medical endotracheal tube with safe and efficient anti-microbial property, silver is carried for antibacterial with organosilicon, antimicrobial coating is carried out to the surface of PVC trachea cannula conduit, through sol-gel method, study the organosilicon Ag-carried antibacterial coating trachea cannula conduit be prepared from, Fig. 1 is TEOS/KH570/MTES/Ag-SiO 2the preparation flow schematic block diagram of the organosilicon Ag-carried antibacterial colloidal sol of quaternary system, elaborates to concrete preparation process of the present invention below in conjunction with accompanying drawing:
Embodiment 1
(1), with ethyl orthosilicate (TEOS) for silicon source, with gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) for organic facies presoma, with the ratio of TEOS/KH570/MTES=15/6/1, be there is by the preparation of sol-gel technology room temperature the TEOS/KH570/MTES organic silicon sol of multifunctional molecule level compound.The syntheti c route of organosilicon complex sol is as Fig. 1: first by TEOS, dehydrated alcohol and deionized water mix homogeneously under magnetic stirring apparatus, add acetic acid, TEOS is hydrolyzed reaction, obtain silicon dioxide gel, add KH570 and MTES mixed solution again, continue stirring to be hydrolyzed condensation reaction, obtain organosilicon complex sol.Si-OH, R1-COO-R, Si-O-Si group that organic silicon sol contains can show good film property, Si-CH 3,-CH 3coating surface energy can be reduced, thus prevent proteinaceous tissue cell adhesion.
(2), by hydrolytic crosslinking, mechanical mix techniques, by high speed shear effect, by inorganic nano silver antibacterial agent with 1.0% concentration add in prefabricated TEOS/KH570/MTES organic silicon sol, make silver antibacterial agent can be uniformly dispersed in organosilicon complex sol, prepared the TEOS/KH570/MTES/Ag-SiO of clear by chemical bonding and physisorption 2the organosilicon Ag-carried antibacterial modification sol of quaternary system;
(3), by PVC trachea cannula conduit surface activation process: by washing with alcohol, catheter surface impurity is removed, after drying, sided corona treatment.(high-frequency ac voltage is up to 5000-15000V/m at PVC trachea cannula conduit corona discharge to utilize high-frequency high-voltage 2) and produce low temperature plasma, these gas ions destroy its molecular structure by shocking by electricity and penetrating into PVC surface, and then by the oxidation of processed surface molecular and polarization, produce the free radicals such as-O-O-,-OH, increase surface roughness simultaneously, reduce surface energy, improve surface adhesion force, realize PVC base surface active.PVC trachea cannula conduit surface organosilicon Ag-carried antibacterial modification sol being coated surface active by Dipcoat method is prepared conduit and to be wet dissolved glue film; Adopt heat curing process, dry solidification 30 minutes at 100 DEG C of temperature, obtain coating layer thickness and control at 300nm, coating surface is uniform ground very, without granule and phenomenon of phase separation, has the TEOS/KH570/MTES/Ag-SiO of excellent antibacterial performance 2organosilicon Ag-carried antibacterial coating trachea cannula conduit.
TEOS/KH570/MTES/Ag-SiO of the present invention is proved below by specific experiment 2organosilicon carries beneficial effect and the excellent properties of silver coating PVC trachea cannula conduit:
(1) anti-microbial property
Blank PVC trachea cannula conduit sample is one group, TEOS/KH570/MTES/Ag-SiO 2organosilicon Ag-carried antibacterial coating PVC trachea cannula conduit sample is another group, the sterilizing rate of effects on surface field planting antibacterial reaches more than 95% for standard, blank PVC trachea cannula conduit sample and organosilicon carry 4 groups, the PVC trachea cannula conduit sample of silver coating, impregnated in 1.0 × 10 5in standard gold Staphylococcus aureus bacterium liquid, spend the night 24h, pipettes 10ul impregnation liquid and be coated with inoculation on blood agar culture-medium, and after 35 DEG C of incubated overnight, counting clump count, observes the relative growth situation of antibacterial, to show its anti-microbial property.The result of contrast experiment confirms: blank PVC trachea cannula conduit sample bacterium normal growth, TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating PVC trachea cannula conduit sample bacterium and grows obvious minimizing and even disappear, and sterilizing rate reaches more than 98%, TEOS/KH570/MTES/Ag-SiO 2the anti-microbial property that organosilicon carries silver coating PVC trachea cannula conduit sample is stronger.
(2) coating mechanical property
To TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating inspection, and testing result is: coating hardness 3H, adhesive force 0 grade, and stability of emulsion is without precipitation or gel.(note: 1, coating layer thickness controls at 200-400nm, heat treatment temperature: 80 DEG C, processing time: 60min.2, hardness, adhesive force: testing standard is with reference to ISO15184-2012, ISO2409-2007, pencil scratch hardness instrument and paint film lattice drawing device is adopted to detect coating hardness, coating adhesion, use Tianjin Material Testing Machine factory to produce QHQ-A type pencil test instrument to test, unit B or H represents mensuration progression; The firmness combined between coating and coated surface is called adhesive force, and coating adhesion observes the situation of coating shedding according to cross-hatching, is divided into 0 grade-5 grades, and wherein 0 grade is without coming off, best performance.Whether 3, stability: emulsion room temperature leaves standstill 72h, observe and precipitate or gel.) testing result can show, TEOS/KH570/MTES/Ag-SiO 2the coating of quaternary system has good mechanical property and good stability.
(3) face coat pattern
Fig. 2 observes the information that can provide catheter surface coating morphology and uniformity by scanning electron microscope (SEM).Coating amplifies 5,000 times, can find out that this coating surface is very smooth, without any concavo-convex, TEOS/KH570/MTES/Ag-SiO is described 2organosilicon carries silver sol compound evenly, does not occur being separated, shows TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver sol and has good adhesive force, profile pattern at catheter surface, really the stronger Interaction System such as covalent bond, hydrogen bond has been defined between inorganic component and organic component, and two components in close are combined, achieve fully running through between inorganic/organic component, system is biphase all one.Test result shows, TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver sol and defines fine and close network structure, and thin film is stable without phase-splitting.
(4) transmitance
Blank PVC trachea cannula conduit sample transmitance detects, and calculating mean transmissivity is 87.55%; TEOS/KH570/MTES/Ag-SiO 2the mean transmissivity that organosilicon carries silver coating trachea cannula conduit sample is 87.39%, illustrates that before and after coating, base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and there is not the uneven phase making visible ray generation scattering.
(5) silver ion is separated out
By Inductively coupled plasma mass spectrometry determination and analysis antimicrobial coating silver ion amount of precipitation after hardening, with the combination degree of clear and definite antibacterial and catheter surface.Silver ion is substantially without precipitation after hardening for antimicrobial coating, and the concentration of silver ions that blank PVC trachea cannula conduit sample immersion (being respectively 40 DEG C and 80 DEG C) deionized water measured after 24 hours is 0.002 μ g/L; TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating trachea cannula conduit sample and soaks the concentration of silver ions that measures after 24 hours of (being respectively 40 DEG C and 80 DEG C) deionized water and be respectively 0.005 μ g/L and 0.009 μ g/L.Contrast blank PVC trachea cannula conduit sample, discharge error component, illustrates organosilicon carry silver coating trachea cannula conduit sample immersion (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion precipitation be 0.003 μ g/L and 0.007 μ g/L; The concentration determination that silver ion in silver-colored titanium dioxide anti-bacterial agent is carried in contrast is 25 μ g/L.The silver ion of visible antimicrobial coating pipe is separated out almost negligible.
TEOS/KH570/MTES/Ag-SiO of the present invention is proved below by specific experiment 2organosilicon carries the biological untoward reaction of silver coating PVC trachea cannula conduit:
(1) oral mucosa irritant test
According to GB/T16886.10-2005 standard, blank PVC trachea cannula conduit sample and TEOS/KH570/MTES/Ag-SiO 2the 0.9% sodium chloride injection polarity lixiviating solution that organosilicon carries silver coating PVC trachea cannula conduit sample contacts with Golden Hamster oral mucosa respectively with the nonpolar lixiviating solution of Oleum Gossypii semen, observe the local organization extent of reaction, to evaluate the stimulation of antimicrobial coating tracheal intubation to oral mucosa.Result of the test, perusal finds blank tube and coated pipe cheek pouch test side and control sides mucomembranous surface is smooth, without changes such as hyperemia, edema, ulcer and erosions; The tissue slice Microscopic observation of 0.9% sodium chloride injection polarity lixiviating solution test side and control sides, oral mucous epithelia is complete, epithelial cell has no hypertrophy, flatten, degeneration or necrosis, has no the pathological changes such as hyperemia, edema, inflammatory infiltration and necrosis under mucosa.The oral mucosa Acute exposure tissue reaction mean score of 0.9% sodium chloride injection polarity lixiviating solution is 0, prompts for non-stimulated; The tissue slice Microscopic observation of Oleum Gossypii semen nonpolar lixiviating solution test side and control sides, oral mucous epithelia is complete, epithelial cell has no hypertrophy, flatten, degeneration or necrosis, has no the pathological changes such as hyperemia, edema, inflammatory infiltration and necrosis under mucosa; The oral mucosa Acute exposure tissue reaction mean score of the nonpolar lixiviating solution of Oleum Gossypii semen is 0, prompt for non-stimulated, result of the test shows, 0.9% sodium chloride injection polarity lixiviating solution of blank tube and antimicrobial coating pipe and the oral mucosa irritant test result of the nonpolar lixiviating solution of Oleum Gossypii semen are non-stimulated.
(2) pyrogen testing
According to " Chinese Pharmacopoeia " version in 2010, silver coating PVC trachea cannula conduit sample is carried to organosilicon and carries out pyrogen testing.Result shows: the maximum intensification that injection organosilicon carries 3 rabbits of silver coating PVC trachea cannula conduit sample 0.9% sodium chloride injection lixiviating solution is respectively 0 DEG C, 0 DEG C, 0.03 DEG C, and total intensification is 0.03 DEG C; According to the criterion of Chinese Pharmacopoeia 2010 editions, this product is without material pyrogenic action, and pyrogen testing result is qualified.
(3) hemolytic test
The hemolytic test method specified according to GB/T16886.4-2003, silver coating PVC trachea cannula conduit sample is carried to organosilicon and carries out hemolytic test, sample is directly contacted with blood, by measuring the hemoglobin content of erythrocyte release to judge that organosilicon carries the hemolysis in vitro degree of silver coating PVC trachea cannula conduit sample.Result shows: when the hemolysis rate that organosilicon carries silver coating PVC trachea cannula conduit sample is 0.7512%(experimental examination medical apparatus and instruments, qualification determination index hemolysis rate should be less than 5%.), hemolytic test result is qualified.
(4) acute systemic toxicity
According to GB/T16886.11-2011 standard, observe organosilicon and carry silver coating PVC trachea cannula conduit sample to chmice acute general toxic reaction.The 0.9% sodium chloride injection lixiviating solution that blank PVC trachea cannula conduit sample and organosilicon carry silver coating PVC trachea cannula conduit sample gives with tail vein injection mode single, the Oleum Gossypii semen lixiviating solution of two kinds of samples gives with lumbar injection mode single, and using corresponding lixiviate medium as blank.Injection rear 4,24,48 and 72h, observe mouse toxicity response situation, found that, blank liquid group, blank PVC trachea cannula conduit sample and organosilicon carry silver coating PVC trachea cannula conduit sample lixiviating solution group and are showed no abnormal response.Result shows: organosilicon carries the acute systemic toxicity result of silver coating PVC trachea cannula conduit two kinds of lixiviating solution for meeting avirulence requirement, and the acute systemic toxicity indifference of blank PVC trachea cannula conduit sample.
(5) cell toxicity test
The cell toxicity test method specified according to GB/T16886.5-2003, carries silver coating PVC trachea cannula conduit sample to organosilicon and carries out cell toxicity test.Calf serum MEM culture medium preparation organosilicon with 10% carries silver coating PVC trachea cannula conduit sample lixiviating solution cultivates NCTC colone929 cell (l cell), and make negative control with blank PVC trachea cannula conduit sample lixiviating solution, 5g/L phenol solution makes positive control.Result of the test: the cellular morphology of negative control is normal, and adherent growth is good, has discrete particle, acellular dissolving in endochylema; The Growth of Cells of positive control is not good, the rounded or cytolysis of more than 90% cell; Organosilicon carries cellular morphology in silver coating PVC trachea cannula conduit sample lixiviating solution, and normally, adherent growth is good, has discrete particle, acellular dissolving in endochylema.Organosilicon carries silver coating PVC trachea cannula conduit sample and blank PVC trachea cannula conduit sample lixiviating solution is all chosen as nontoxic, judge to be classified as 0 grade (cell-cytotoxic reaction as 0 grade or 1 grade as qualified.)。Cultivate 48 hours monitoring cell OD 5 70degree of increment relatively, organosilicon carries silver coating PVC trachea cannula conduit sample and blank PVC trachea cannula conduit sample lixiviating solution all judges to be classified as 0 grade, and it is qualified that organosilicon carries silver coating PVC trachea cannula conduit sample cell toxicity test result.
Embodiment 2
We prepare TEOS/KH570/MTES/Ag-SiO with the method that embodiment 1 is same 2the organosilicon Ag-carried antibacterial coating trachea cannula conduit of quaternary system, wherein TEOS/KH570/MTES=14/7/3, inorganic nano-silver antimicrobial agent concentration are 1.3%.Adopt heat curing process, dry solidification 50 minutes at 90 DEG C of temperature, obtain coating layer thickness and control at 400nm.
As follows with the detection method testing result that embodiment 1 is same:
(1) anti-microbial property
TEOS/KH570/MTES/Ag-SiO 2organosilicon carries the growth of silver coating PVC trachea cannula conduit sample bacterium and almost disappears, and sterilizing rate reaches more than 99.8%.
(2) coating mechanical property
TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating testing result: coating hardness 4H, adhesion 1 grade, and stability of emulsion is without precipitation or gel.
(3) face coat pattern
Fig. 3
Observe catheter surface coating morphology by scanning electron microscope (SEM), can find out that this coating surface is very smooth, without any concavo-convex, TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver sol and defines fine and close network structure, and thin film is stable without phase-splitting, and circular granule has appearred in coating surface, particle diameter is between 1 ~ 5um, also occur that few particle size reaches 10um, from picture, do not observe nano level granule, less granule has been embedded in the coating all.
(4) transmitance
TEOS/KH570/MTES/Ag-SiO 2the mean transmissivity that organosilicon carries silver coating trachea cannula conduit is 87.10%, illustrates that before and after coating, base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and there is not the uneven phase making visible ray generation scattering.
(5) silver ion is separated out
By Inductively coupled plasma mass spectrometry determination and analysis organosilicon Ag-carried antibacterial coating silver ion amount of precipitation after hardening, TEOS/KH570/MTES/Ag-SiO 2organosilicon carry silver coating trachea cannula conduit sample immersion (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion precipitation be 0.004 μ g/L and 0.007 μ g/L, the concentration determination that silver ion in silver-colored titanium dioxide anti-bacterial agent is carried in contrast is 25 μ g/L, and the silver ion of visible antimicrobial coating pipe is separated out almost negligible.Illustrate organosilicon Ag-carried antibacterial coating after hardening silver ion substantially without precipitation.
As the method test TEOS/KH570/MTES/Ag-SiO of embodiment 1 2organosilicon carries the biological untoward reaction of silver coating PVC trachea cannula conduit, and test result is as follows:
(1) oral mucosa irritant test
0.9% sodium chloride injection polarity lixiviating solution of organosilicon Ag-carried antibacterial coated pipe and the oral mucosa irritant test result of the nonpolar lixiviating solution of Oleum Gossypii semen are non-stimulated.
(2) pyrogen testing
Organosilicon Ag-carried antibacterial coated pipe is without material pyrogenic action, and pyrogen testing result is qualified.
(3) hemolytic test
The hemolysis rate of organosilicon Ag-carried antibacterial coated pipe is 0.7750%, and hemolytic test result is qualified.
(4) acute systemic toxicity
The acute systemic toxicity result of organosilicon Ag-carried antibacterial coated pipe 0.9% sodium chloride injection polarity lixiviating solution and the nonpolar lixiviating solution of Oleum Gossypii semen is for meeting avirulence requirement.
(5) cell toxicity test
In organosilicon Ag-carried antibacterial coated pipe lixiviating solution, cellular morphology is normal, and adherent growth is good, has discrete particle, acellular dissolving, be chosen as nontoxic in endochylema, judges to be classified as 0 grade; Cultivate 48 hours monitoring cell OD 5 70judge to be classified as 0 grade with relative increment degree.Organosilicon Ag-carried antibacterial coated pipe cell toxicity test result is qualified.
Embodiment 3:
We prepare TEOS/KH570/MTES/Ag-SiO with the method that embodiment 1 is same 2the organosilicon Ag-carried antibacterial coating trachea cannula conduit of quaternary system, wherein TEOS/KH570/MTES=16/5/1, inorganic nano-silver antimicrobial agent concentration are 0.8%, adopt heat curing process, dry solidification 60 minutes at 80 DEG C of temperature, obtain coating layer thickness and control at 200nm.
As follows with the detection method testing result that embodiment 1 is same:
(1) anti-microbial property
TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating PVC trachea cannula conduit sample bacterium and grows obvious minimizing and even disappear, and sterilizing rate reaches 96.3%.
(2) coating mechanical property
TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver coating testing result: coating hardness 5H, adhesive force 0 grade, and stability of emulsion is without precipitation or gel.
(3) face coat pattern
Fig. 4
Observe catheter surface coating morphology by scanning electron microscope (SEM), this coating surface very uniform ground can be found out, without any concavo-convex, TEOS/KH570/MTES/Ag-SiO 2organosilicon carries silver sol and defines fine and close network structure, and thin film is stable without phase-splitting, and coating surface is very smooth, without granule and phenomenon of phase separation.
(4) transmitance
TEOS/KH570/MTES/Ag-SiO 2the mean transmissivity that organosilicon carries silver coating trachea cannula conduit is 87.90%, illustrates that before and after coating, base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and there is not the uneven phase making visible ray generation scattering.
(5) silver ion is separated out
By Inductively coupled plasma mass spectrometry determination and analysis organosilicon Ag-carried antibacterial coating silver ion amount of precipitation after hardening, TEOS/KH570/MTES/Ag-SiO 2organosilicon carry silver coating trachea cannula conduit sample immersion (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion precipitation be 0.003 μ g/L and 0.006 μ g/L, the concentration determination that silver ion in silver-colored titanium dioxide anti-bacterial agent is carried in contrast is 25 μ g/L, and the silver ion of visible antimicrobial coating pipe is separated out almost negligible.Illustrate organosilicon Ag-carried antibacterial coating after hardening silver ion substantially without precipitation.
As the method test TEOS/KH570/MTES/Ag-SiO of embodiment 1 2organosilicon carries the biological untoward reaction of silver coating PVC trachea cannula conduit, and test result is as follows:
(1) oral mucosa irritant test
0.9% sodium chloride injection polarity lixiviating solution of organosilicon Ag-carried antibacterial coated pipe and the oral mucosa irritant test result of the nonpolar lixiviating solution of Oleum Gossypii semen are non-stimulated.
(2) pyrogen testing
Organosilicon Ag-carried antibacterial coated pipe is without material pyrogenic action, and pyrogen testing result is qualified.
(3) hemolytic test
The hemolysis rate of organosilicon Ag-carried antibacterial coated pipe is 0.7144%, and hemolytic test result is qualified.
(4) acute systemic toxicity
The acute systemic toxicity result of organosilicon Ag-carried antibacterial coated pipe 0.9% sodium chloride injection polarity lixiviating solution and the nonpolar lixiviating solution of Oleum Gossypii semen is for meeting avirulence requirement.
(5) cell toxicity test
In organosilicon Ag-carried antibacterial coated pipe lixiviating solution, cellular morphology is normal, and adherent growth is good, has discrete particle, acellular dissolving, be chosen as nontoxic in endochylema, judges to be classified as 0 grade; Cultivate 48 hours monitoring cell OD 5 70judge to be classified as 0 grade with relative increment degree.Organosilicon Ag-carried antibacterial coated pipe cell toxicity test result is qualified.
What more than enumerate is only some embodiments of the present invention; obviously, the invention is not restricted to above embodiment, many distortion can also be had; all distortion that those of ordinary skill in the art can directly derive from content disclosed by the invention or associate, all should think protection scope of the present invention.

Claims (8)

1. one kind has the medical endotracheal tube of safe and efficient anti-microbial property, it is characterized in that, with ethyl orthosilicate (TEOS) for silicon source, with gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) for organic facies presoma, take inorganic nano-silver as antibacterial, through sol-gel method, prepare TEOS/KH570/MTES/Ag-SiO 2the organosilicon Ag-carried antibacterial colloidal sol of quaternary system; Again with clinical conventional polrvinyl chloride (PVC) trachea cannula conduit for base material, carry out antibacterial surface coating, be prepared from organosilicon Ag-carried antibacterial coating trachea cannula conduit.
2. have a preparation method for the endotracheal tube of safe and efficient anti-microbial property as claimed in claim 1, it is characterized in that, concrete preparation process is as follows:
(1), the preparation of organic silicon sol: with ethyl orthosilicate (TEOS) for silicon source, with gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) for organic facies presoma, be there is by the preparation of sol-gel technology room temperature the TEOS/KH570/MTES organic silicon sol of multifunctional molecule level compound;
(2), organosilicon Ag-carried antibacterial modification sol preparation: by hydrolytic crosslinking, mechanical mix techniques, by high speed shear effect, inorganic nano silver antibacterial agent is added in prefabricated TEOS/KH570/MTES organic silicon sol, make silver antibacterial agent can be uniformly dispersed in organosilicon complex sol, prepared the TEOS/KH570/MTES/Ag-SiO of clear by chemical bonding and physisorption 2the organosilicon Ag-carried antibacterial modification sol of quaternary system;
(3), trachea cannula conduit surface activation process: by washing with alcohol, remove catheter surface impurity, after drying, sided corona treatment, high-frequency high-voltage is utilized to produce low temperature plasma at trachea cannula conduit corona discharge, these gas ions destroy its molecular structure by shocking by electricity and penetrating into PVC catheter surface, and then by the oxidation of processed surface molecular and polarization, produce the free radicals such as-O-O-,-OH, increase surface roughness simultaneously, reduce surface energy, improve surface adhesion force, realize PVC base surface active;
(4) the trachea cannula conduit surface, by Dipcoat method organosilicon Ag-carried antibacterial modification sol being coated surface active is prepared conduit and to be wet dissolved glue film, adopts heat curing process, obtains the TEOS/KH570/MTES/Ag-SiO with excellent antibacterial performance 2organosilicon Ag-carried antibacterial coating trachea cannula conduit.
3. the preparation method with the trachea cannula conduit of safe and efficient anti-microbial property according to claim 2, it is characterized in that, in described step (1), the concrete preparation process of organosilicon complex sol is: first by TEOS, dehydrated alcohol and deionized water mix homogeneously under magnetic stirring apparatus, add acetic acid, TEOS is hydrolyzed reaction, obtain silicon dioxide gel, add KH570 and MTES mixed solution again, continue stirring to be hydrolyzed condensation reaction, obtain organosilicon complex sol.
4. the preparation method with the trachea cannula conduit of safe and efficient anti-microbial property according to claim 3, it is characterized in that, in described step (1), the ratio of described TEOS/KH570/MTES is (14 ~ 16)/(5 ~ 7)/(1 ~ 3).
5. want the preparation method with the trachea cannula conduit of safe and efficient anti-microbial property described in 2 according to right, it is characterized in that, in described step (2), the concentration of inorganic nano silver antibacterial agent is 0.8% ~ 1.3%.
6. want the preparation method with the trachea cannula conduit of safe and efficient anti-microbial property described in 2 according to right, it is characterized in that, described step (3) medium-high frequency high voltage is 5000-15000V/m 2.
7. want the preparation method with the trachea cannula conduit of high-efficiency antimicrobial performance described in 2 according to right, it is characterized in that, adopt in described step (4) heat curing process to refer to and process 30 ~ 60 minutes at 80 ~ 100 DEG C of temperature.
8. want the preparation method with the trachea cannula conduit of safe and efficient anti-microbial property described in 2 according to right, it is characterized in that, the described TEOS/KH570/MTES/Ag-SiO with excellent antibacterial performance described in step (4) 2the coating layer thickness of organosilicon Ag-carried antibacterial coating trachea cannula conduit is at 200 ~ 400nm.
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5026607A (en) * 1989-06-23 1991-06-25 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
CN101353502A (en) * 2008-09-11 2009-01-28 哈尔滨工程大学 Polytetrafluorethylene coating material for medical apparatus surface and coating method thereof
CN101554483A (en) * 2008-04-08 2009-10-14 拜尔材料科学股份公司 Medical Devices with Antimicrobial Polyurethane Coatings
CN101628133A (en) * 2009-08-11 2010-01-20 中国人民解放军第三军医大学第一附属医院 Medical catheter carrying slow-release antibiotic coating and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5026607A (en) * 1989-06-23 1991-06-25 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
CN101554483A (en) * 2008-04-08 2009-10-14 拜尔材料科学股份公司 Medical Devices with Antimicrobial Polyurethane Coatings
CN101353502A (en) * 2008-09-11 2009-01-28 哈尔滨工程大学 Polytetrafluorethylene coating material for medical apparatus surface and coating method thereof
CN101628133A (en) * 2009-08-11 2010-01-20 中国人民解放军第三军医大学第一附属医院 Medical catheter carrying slow-release antibiotic coating and preparation method thereof

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