CN103948973A - Medical tracheal catheter with safe and effective antibacterial performance - Google Patents
Medical tracheal catheter with safe and effective antibacterial performance Download PDFInfo
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- CN103948973A CN103948973A CN201410160736.5A CN201410160736A CN103948973A CN 103948973 A CN103948973 A CN 103948973A CN 201410160736 A CN201410160736 A CN 201410160736A CN 103948973 A CN103948973 A CN 103948973A
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Abstract
The invention discloses a medical tracheal catheter with safe and effective antibacterial performance. The organic silicon silver-loaded antibacterial coating tracheal intubation catheter is prepared by using tetraethoxysilane (TEOS) as a silicon source, gamma-methacryloxy propyl trimethoxyl silane (KH570) and methyl triethoxysilane (MTES) as organic-phase precursors and inorganic nano-silver as an antibacterial agent, adopting a sol-gel method, taking a tracheal intubation catheter as a base material and applying a surface antibacterial coating. The organic silicon silver-loaded antibacterial coating tracheal intubation catheter can be used for reducing related infectious complications in the tracheal catheter staying process, reducing the state of a patient, prolonging the catheter staying time to win precious time to successfully rescue of critically ill patients, and reducing economic burden of medical care, treatment risks and physical and psychological torture of patients, so that the disease prognosis of a tracheal intubated patient can be improved.
Description
Technical field
This patent relates to medical field, and concrete must saying is a kind of organosilicon Ag-carried antibacterial coating Medical trachea cannula conduit.
Background technology
Tracheal intubation is during critical patients rescues, to set up the simple and direct effective method of unobstructed air flue.Except patients undergoing general anesthesia, in many critical patients' rescue process, in order effectively to carry out mechanical ventilation, remove intra-tracheal sputum liquid or blood, prevent that vomiting from suffocating, remove respiratory tract obstruction, often need carry out tracheal intubation.The artificial airway that tracheal intubation is set up, becomes patient most important " life line ".Once patient has implemented tracheal intubation, 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 use is mainly made up of medical polyvinyl (PVC), conduit has adhesiveness to airway secretions, after intubate air flue mucosa oppress, rub, stimulation etc., causing that mucosa injury is even carcinogenic may.And after MV via intubation 48h, easily cause respiratory tract infection---Ventilator Associated Pneumonia, and this also becomes complication the most common and the most serious in during mechanical ventilation, and sickness rate, case fatality rate are high, and therapeutic effect is poor, and medical resource consumption is large.The measure of taking is at present mainly positive anti-infective therapy, air flue humidification, effective nursing etc., 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) of having formulated VAP
[2], suggestion adopts semireclining position, reduces tranquilizer use, prevents peptic ulcer mouth care to occur, strengthens, strengthen the measures such as medical worker's hand hygiene and strict sterile working, prevents the generation of VAP.But it is less that these measures insert to trachea cannula conduit the preventive and therapeutic effect that the bacterial growth that causes and drug resistance occur.The respiratory tract infection and the common pathogen of Ventilator Associated Pneumonia that cause because of tracheal intubation are Pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, Acinetobacter bauamnnii, Klebsiella Pneumoniae etc.
[3], and these antibacterials can be in succession in intubation or overlapping appearance, shows the even general drug resistance of multidrug resistant
[4].The particularly as easy as rolling off a log tracheal intubation surface that sticks to of Pseudomonas aeruginosa, and secrete polysaccharide matrix, fibrin, lipoprotein etc. and make the inter-adhesive gathering of antibacterial, after several hours, just can form biofilm on surface 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 most thorny antibacterial of nosocomial infection thereupon
[5].Clinical use antibiosis is is usually prevented and treated 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 cannot effectively controlling respiratory tract infection and death, and the antimicrobial drug of development of new antimicrobial agent is overnight non-
[6].The complication of tracheal intubation is the generation of Ventilator Associated Pneumonia particularly, 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, greatly 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, just energy elongate catheter indwelling time, strives for the quality time for patient rescues, and improves treatment success rate, also can reduce medical economy burden, alleviate patient's body and mind misery.At present, Chinese scholars focuses on sight in the antibacterial surface modification of trachea cannula conduit, 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-Fowler V etc.
[7]adopt silver ion and CHLORHEXIDINE complex to develop 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 separating out of silver ion, thereby do not use at clinical expansion.Raad II 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 can not reduce the adhesiveness of catheter surface to airway secretions, 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 that effectively anti-bacteria is grown and field planting at respiratory tract, but have the risk that increases bacterial drug resistance.Kollef etc.
[10]develop the trachea cannula conduit of silver ion coating, and carry out random, single blind prospective control study in 54Ge research center, North America, the trachea cannula conduit that found that silver ion coating can obviously reduce and postpone the generation of VAP, but the toleration of opposed pipe, the occupancy rate of ICU, hospital stays, mortality rate etc. are impact no, and silver ion separates out and also fail effectively to prevent, there is obvious side reaction.Because these antibacterial trachea cannula conduits of newly developing are owing to there being 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 has changed the material of antimicrobial coating in the past, overcome the deficiency of the antibacterial endotracheal tube of development in the past, 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 be the clinical trachea cannula conduit with safe and efficient anti-microbial property that provides.
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.Guidelines?for?the?management?of?adults?with?hospital-acquired,ventilator-associated,and?healthcare-associated?pneumonia［J］.Am?J?Respir?Crit?Care?Med,2005,171(4):388-416.
3. all fine, Hu Bijie, the .2009-2010 Shanghai City ICU of the 65Suo hospital catheter associated infection Target Monitorings such as Gao Xiaodong are analyzed [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?soy?isoflavone?genistein[J].Basic?Microbiol,2006,46(4):329-335.
5. a Yi is rich, 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?impregnated?endotracheal?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?colonization?by?multidrug-resistant?pathogens?that?cause?ventilator-associated?pneumonia?with?antimicrobial-coated?endotracheal?tubes[J].Biomaterials.2011,32(11):2689-2694.
9.Berra?L,Kolobow?T,Laquerriere?P,etal.Internally?coated?endotracheal?tubes?with?silver?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?and?incidence?of?ventilator-associated?pneumonia?the?NASCENT?randomized?trial[J].JAMA,2008,300(7):805-813.
Summary of the invention
The weak point that this patent exists in order to overcome the antibacterial trachea cannula conduit of the PVC trachea cannula conduit of existing clinical use and development at present just, provide one can reduce tracheal intubation and insert postoperative infection complication, there is not again biological untoward reaction, be applicable to the trachea cannula conduit of the organosilicon Ag-carried antibacterial coating of human body use.
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, taking ethyl orthosilicate (TEO S) as silicon source, with γ-
Methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) are organic facies presoma, taking 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; Taking trachea cannula conduit as base material, carry out antibacterial surface coating again, be prepared from organosilicon Ag-carried antibacterial coating trachea cannula conduit.
As further improvement, trachea cannula conduit of the present invention is taking 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), taking ethyl orthosilicate (TEOS) as silicon source, taking gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) as organic facies presoma, taking inorganic nano-silver as antibacterial, there is the compound TEOS/KH570/MTES organic silicon sol of multifunctional molecule level by the preparation of sol-gel technology room temperature;
(2), by hydrolytic crosslinking, mechanical mixture method, by high speed shear effect, inorganic nano silver antibacterial agent is added in prefabricated TEOS/KH570/MTES organic silicon sol, silver antibacterial agent is can be uniformly dispersed in organosilicon complex sol, prepare the TE OS/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, utilize high-frequency high-voltage to produce low temperature plasma at trachea cannula conduit corona discharge, these gas ions are by shocking by electricity and penetrating into its molecular structure of PVC surface breakdown, and then by processed surface molecular oxidation and polarization, generation-the O-O-,-free radicals such as OH, increase surface roughness simultaneously, fall low-surface-energy, improve surface adhesion force, realize the activation of PVC substrate surface;
(4), the trachea cannula conduit surface of organosilicon Ag-carried antibacterial modification sol being coated to surface active by dip coated method prepares the wet dissolved glue film of conduit, adopts heat curing process, obtains the TEOS/KH570/MTES/Ag-SiO with excellent anti-microbial property
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, make the TEOS reaction that is hydrolyzed, obtain silicon dioxide gel, add again KH570 and MTES mixed solution, continue to stir the condensation reaction that is hydrolyzed, obtain organosilicon complex sol;
As improving further, in step of the present invention (1), the ratio of described TEOS/KH570/MTE S 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
3can reduce coating surface energy, thereby 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, in step of the present invention (4), adopt heat curing process to refer at 80～100 DEG C of temperature and process 30～60 minutes.
As improving further, the TEOS/KH570/MTES/Ag-SiO with excellent anti-microbial property 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.
Useful technique effect 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, can alleviate patient's the state of an illness, 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 simultaneously and torment, thereby improve intubation prognosis of disease.
In addition, we are mainly made up of PVC by the trachea cannula conduit of clinical use, antibacterial easily adhere to growth form biofilm make to infect be difficult to control, PVC material easily causes the untoward reaction such as sputum adhesion, oral cavity air flue mucosa injury, and generate business abroad, this conduit is had to monopoly position, domestic production enterprise does not still have autonomous patent right, and the patient that need to carry out MV via intubation clinical middle every day is countless.Our the patent finished product organosilicon of research carries silver coating PVC trachea cannula conduit; base oneself upon the reality needs of clinical tracheal intubation; there is high-efficiency antimicrobial performance; and inanimate object untoward reaction; can change into the productivity from scientific research very soon; once large-scale production is also applied to and clinically has important learning value and very high social economic value by contributing for development and the development of China's medicinal career, has a extensive future.
Brief description of the drawings
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 is amplified 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 is amplified 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 is amplified 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, carry silver as antibacterial taking organosilicon, antimicrobial coating is carried out in the surface of PVC trachea cannula conduit, through sol-gel method, the organosilicon Ag-carried antibacterial coating trachea cannula conduit that research is 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), taking ethyl orthosilicate (TEOS) as silicon source, taking gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) as organic facies presoma, with the ratio of TEOS/KH570/MTES=15/6/1, there is the compound TEOS/KH570/MTES organic silicon sol of multifunctional molecule level by the preparation of sol-gel technology room temperature.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, make the TEOS reaction that is hydrolyzed, obtain silicon dioxide gel, add again KH570 and MTES mixed solution, continue to stir the condensation reaction that is hydrolyzed, 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
3can reduce coating surface energy, thereby prevent proteinaceous tissue cell adhesion.
(2), by hydrolytic crosslinking, mechanical mixture method, by high speed shear effect, inorganic nano silver antibacterial agent is added in prefabricated TEOS/KH570/MTES organic silicon sol with 1.0% concentration, silver antibacterial agent is can be uniformly dispersed in organosilicon complex sol, prepare 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, remove catheter surface impurity, 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 are by shocking by electricity and penetrating into its molecular structure of PVC surface breakdown, and then by processed surface molecular oxidation and polarization, generation-the O-O-,-free radicals such as OH, increase surface roughness simultaneously, fall low-surface-energy, improve surface adhesion force, realize the activation of PVC substrate surface.The wet dissolved glue film of conduit is prepared on the P VC trachea cannula conduit surface of organosilicon Ag-carried antibacterial modification sol being coated to surface active by dip coated method; Adopt heat curing process, dry solidification 30 minutes at 100 DEG C of temperature, obtains coating layer thickness and is controlled at 300nm, and coating surface is very evenly smooth, without granule and phenomenon of phase separation, has the TEOS/KH570/MTES/Ag-SiO of excellent anti-microbial property
2organosilicon Ag-carried antibacterial coating trachea cannula conduit.
Prove TEOS/KH570/MTES/Ag-SiO of the present invention 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, it is standard that the sterilizing rate of effects on surface field planting antibacterial reaches more than 95%, 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, the 24h that spends the night, pipettes 10ul impregnation liquid and on blood agar culture-medium, is coated with inoculation, after 35 DEG C of incubated overnight, and counting clump count, the relative growth situation of observing antibacterial, to show its anti-microbial property.Contrast experiment's result confirms: blank PVC trachea cannula conduit sample antibacterial normal growth, TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver coating PVC trachea cannula conduit sample bacterial growth obviously to be reduced even and disappears, 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, and 0 grade of adhesive force, stability of emulsion is without precipitation or gel.(note: 1, coating layer thickness is controlled at 200-400nm, heat treatment temperature: 80 DEG C, the processing time: 60min.2, hardness, adhesive force: testing standard is with reference to ISO15184-2012, ISO2409-2007, adopt pencil scratch hardness instrument and paint film lattice drawing device to detect coating hardness, coating adhesion, use Tianjin Material Testing Machine factory to produce QHQ-A type pencil test instrument and test, unit represents to measure progression with B or H; Between coating and coated surface, the firm degree of combination is called adhesive force, and coating adhesion is observed the situation of coating shedding according to cross-hatching, be 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 is observed catheter surface coating pattern and inhomogeneity information can be provided by scanning electron microscope (SEM).Coating is amplified 5,000 times, can find out that this coating surface is very smooth, without any concavo-convex, TEOS/KH570/MTES/Ag-SiO is described
2it is compound even that organosilicon carries silver sol, do not occur being separated, and shows TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver sol and has good adhesive force, profile pattern at catheter surface, between inorganic component and organic component, really form the stronger Interaction System such as covalent bond, hydrogen bond, and two components are combined closely, realized fully running through between inorganic/organic component, system is biphase equal one.Test result shows, TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver sol and has formed 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%; TE OS/KH570/MTES/Ag-SiO
2the mean transmissivity that organosilicon carries silver coating trachea cannula conduit sample is 87.39%, illustrates before and after coating that base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and do not have the inhomogeneous phase that makes 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 separating out after solidifying, with the combination degree of clear and definite antibacterial and catheter surface.Silver ion is substantially without separating out after solidifying 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 was 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 measured 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, illustrate organosilicon carry silver coating trachea cannula conduit sample immersion (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion to separate out 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.
Prove TEOS/KH570/MTES/Ag-SiO of the present invention 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, blank tube and coated pipe cheek pouch test side is found in perusal and control sides mucomembranous surface is smooth, without variations 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 hyperemia, edema, inflammatory infiltration and the pathological change such as downright bad under mucosa.It is 0 that the acute contact tissue reaction of oral mucosa of 0.9% sodium chloride injection polarity lixiviating solution is on average scored, and prompts for non-stimulated; The tissue slice Microscopic observation of the nonpolar lixiviating solution of Oleum Gossypii semen 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; It is 0 that the acute contact tissue reaction of oral mucosa of the nonpolar lixiviating solution of Oleum Gossypii semen is on average scored, 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, organosilicon is carried to silver coating PVC trachea cannula conduit sample and carry 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, and 0 DEG C, 0.03 DEG C, 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 specifying according to GB/T16886.4-2003, organosilicon is carried to silver coating PVC trachea cannula conduit sample and carry out hemolytic test, sample is directly contacted with blood, carry the external degree of hemolysis of silver coating PVC trachea cannula conduit sample by the hemoglobin content of measuring erythrocyte release to judge organosilicon.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 be showed no abnormal response.Result shows: organosilicon carries the acute systemic toxicity result of two kinds of lixiviating solution of silver coating PVC trachea cannula conduit 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 specifying according to GB/T16886.5-2003, carries silver coating PVC trachea cannula conduit sample to organosilicon and carries out cell toxicity test.Carry silver coating PVC trachea cannula conduit sample lixiviating solution with 10% calf serum MEM culture medium preparation organosilicon and cultivate NCTC colone929 cell (l cell), and make negative control with blank PVC trachea cannula conduit sample lixiviating solution, 5g/L phenol solution is made positive control.Result of the test: the cellular morphology of negative control is normal, and adherent growth is good, has discrete particle in endochylema, acellular dissolving; The Growth of Cells of positive control is not good, the rounded or cytolysis of 90% above cell; It is normal that organosilicon carries in silver coating PVC trachea cannula conduit sample lixiviating solution cellular morphology, and adherent growth is good, has discrete particle in endochylema, acellular dissolving.Organosilicon carry silver coating PVC trachea cannula conduit sample and blank PVC trachea cannula conduit sample lixiviating solution be all chosen as nontoxic, judge be classified as 0 grade (cell-cytotoxic reaction as 0 grade or 1 grade as qualified.）。Cultivate 48 hours monitoring cell OD
5 70with relative increment degree, organosilicon carries silver coating PVC trachea cannula conduit sample and blank PVC trachea cannula conduit sample lixiviating solution all to be judged and is 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 same method of embodiment 1
2the organosilicon Ag-carried antibacterial coating trachea cannula conduit of quaternary system, wherein TEOS/KH570/MTES=14/7/3, inorganic nano silver antibacterial agent concentration are 1.3%.Adopt heat curing process, dry solidification 50 minutes at 90 DEG C of temperature, obtains coating layer thickness and is controlled at 400nm.
The detection method testing result same with embodiment 1 is as follows:
(1) anti-microbial property
TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver coating PVC trachea cannula conduit sample bacterial growth 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, and adhesion 1 grade, stability of emulsion is without precipitation or gel.
(3) face coat pattern
Fig. 3
Observe catheter surface coating pattern 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 has formed 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 all been embedded in coating.
(4) transmitance
TEOS/KH570/MTES/Ag-SiO
2the mean transmissivity that organosilicon carries silver coating trachea cannula conduit is 87.10%, illustrates before and after coating that base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and do not have the inhomogeneous phase that makes 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 separating out after solidifying, TEOS/KH570/MTES/Ag-SiO
2organosilicon carry silver coating trachea cannula conduit sample soak (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion to separate out 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 solidify after silver ion substantially without separating out.
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 in endochylema, acellular dissolving, be chosen as nontoxic, judge be classified as 0 grade; Cultivate 48 hours monitoring cell OD
5 70judge and 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 same method of embodiment 1
2the organosilicon Ag-carried antibacterial coating trachea cannula conduit of quaternary system, wherein TEOS/KH570/MTES=16/5/1, inorganic nano silver antibacterial agent concentration are 0.8%, adopt heat curing process, dry solidification 60 minutes at 80 DEG C of temperature, obtains coating layer thickness and is controlled at 200nm.
The detection method testing result same with embodiment 1 is as follows:
(1) anti-microbial property
TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver coating PVC trachea cannula conduit sample bacterial growth obviously to be reduced even and disappears, and sterilizing rate reaches 96.3%.
(2) coating mechanical property
TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver coating testing result: coating hardness 5H, and 0 grade of adhesive force, stability of emulsion is without precipitation or gel.
(3) face coat pattern
Fig. 4
Observe catheter surface coating pattern by scanning electron microscope (SEM), can find out that this coating surface is very evenly smooth, without any concavo-convex, TEOS/KH570/MTES/Ag-SiO
2organosilicon carries silver sol and has formed 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 before and after coating that base material all has good transmitance, and organosilicon carries between organic facies in silver coating and inorganic phase and do not have the inhomogeneous phase that makes 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 separating out after solidifying, TEOS/KH570/MTES/Ag-SiO
2organosilicon carry silver coating trachea cannula conduit sample soak (being respectively 40 DEG C and 80 DEG C) after 24 hours silver ion to separate out 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 solidify after silver ion substantially without separating out.
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 in endochylema, acellular dissolving, be chosen as nontoxic, judge be classified as 0 grade; Cultivate 48 hours monitoring cell OD
5 70judge and 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 part specific embodiment of the present invention; obviously, the invention is not restricted to above embodiment, can also have many distortion; all distortion that those of ordinary skill in the art can directly derive or associate from content disclosed by the invention, all should think protection scope of the present invention.
Claims (10)
1. a medical endotracheal tube with safe and efficient anti-microbial property, is characterized in that, taking ethyl orthosilicate (TEOS) as silicon source, with γ-
Methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) are organic facies presoma, taking 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; Taking clinical conventional polrvinyl chloride (PVC) trachea cannula conduit as base material, carry out antibacterial surface coating again, be prepared from organosilicon Ag-carried antibacterial coating trachea cannula conduit.
2. the endotracheal tube with safe and efficient anti-microbial property according to claim 1, is characterized in that, described trachea cannula conduit is taking current clinical conventional medical PVC trachea cannula conduit as base material.
3. a preparation method for the endotracheal tube with safe and efficient anti-microbial property as claimed in claim 1 or 2, is characterized in that, concrete preparation process is as follows:
(1), the preparation of organic silicon sol: taking ethyl orthosilicate (TEOS) as silicon source, taking gamma-methyl allyl acyloxypropyl trimethoxysilane (KH570), MTES (MTES) as organic facies presoma, there is the compound TEOS/KH570/MTES organic silicon sol of multifunctional molecule level by the preparation of sol-gel technology room temperature;
(2), organosilicon Ag-carried antibacterial modification sol preparation: by hydrolytic crosslinking, mechanical mixture method, by high speed shear effect, inorganic nano silver antibacterial agent is added in prefabricated TEOS/KH570/MTES organic silicon sol, silver antibacterial agent is can be uniformly dispersed in organosilicon complex sol, prepare 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, utilize high-frequency high-voltage to produce low temperature plasma at trachea cannula conduit corona discharge, these gas ions are destroyed its molecular structure by shocking by electricity and penetrating into PVC catheter surface, and then by processed surface molecular oxidation and polarization, generation-the O-O-,-free radicals such as OH, increase surface roughness simultaneously, fall low-surface-energy, improve surface adhesion force, realize the activation of PVC substrate surface;
(4), the trachea cannula conduit surface of organosilicon Ag-carried antibacterial modification sol being coated to surface active by dip coated method prepares the wet dissolved glue film of conduit, adopts heat curing process, obtains the TEOS/KH570/MTES/Ag-SiO with excellent anti-microbial property
2organosilicon Ag-carried antibacterial coating trachea cannula conduit.
4. the preparation method of the trachea cannula conduit with safe and efficient anti-microbial property according to claim 3, it is characterized in that, in described step (1), the concrete preparation process of organosilicon complex sol is: first by TEO S, dehydrated alcohol and deionized water mix homogeneously under magnetic stirring apparatus, add acetic acid, make the TEOS reaction that is hydrolyzed, obtain silicon dioxide gel, add again KH570 and MTES mixed solution, continue to stir the condensation reaction that is hydrolyzed, obtain organosilicon complex sol.
5. the preparation method of the trachea cannula conduit with safe and efficient anti-microbial property according to claim 4, it is characterized in that, in described step (1), the ratio of described TEOS/KH570/MTES is (14～16)/(5～7)/(1～3).
6. the preparation method of the trachea cannula conduit with safe and efficient anti-microbial property according to claim 4, is characterized in that, Si-OH, R1-COO-R, Si-O-Si group that described organic silicon sol contains can show good film property, Si-CH
3,-CH
3can reduce coating surface energy, thereby prevent proteinaceous tissue cell adhesion.
7. the preparation method of wanting the trachea cannula conduit with safe and efficient anti-microbial property described in 3 according to right, is characterized in that, in described step (2), the concentration of inorganic nano silver antibacterial agent is 0.8%～1.3%.
8. the preparation method of wanting the trachea cannula conduit with safe and efficient anti-microbial property described in 3 according to right, is characterized in that, described step (3) medium-high frequency high voltage is 5000-15000V/m
2.
9. the preparation method of wanting the trachea cannula conduit with high-efficiency antimicrobial performance described in 3 according to right, is characterized in that, adopts heat curing process to refer at 80～100 DEG C of temperature and process 30～60 minutes in described step (4).
10. the preparation method of wanting the trachea cannula conduit with safe and efficient anti-microbial property described in 3 according to right, is characterized in that, the TEOS/KH570/MTES/Ag-SiO with excellent anti-microbial property described in described step (4)
2the coating layer thickness of organosilicon Ag-carried antibacterial coating trachea cannula conduit is at 200～400nm.
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| CN105233384A (en) * | 2015-09-19 | 2016-01-13 | 陕西省人民医院 | Trachea cannula capable of monitoring air bag pressure automatically |
| CN105462261A (en) * | 2015-12-22 | 2016-04-06 | 合肥仲农生物科技有限公司 | Anti-infection nano composite material |
| CN107075278A (en) * | 2014-08-06 | 2017-08-18 | 阿法玛公司 | Elastic composition comprising lichenic acid and the equipment by its preparation or coating |
| CN108095843A (en) * | 2017-12-25 | 2018-06-01 | 大连三生科技发展有限公司 | A kind of antibacterial tooth-implanting base station |
| CN108144118A (en) * | 2017-12-25 | 2018-06-12 | 大连三生科技发展有限公司 | A kind of preparation method of antibacterial tooth-implanting base station |
| CN108144117A (en) * | 2017-12-25 | 2018-06-12 | 大连三生科技发展有限公司 | A kind of tooth-implanting base station |
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| CN107075278A (en) * | 2014-08-06 | 2017-08-18 | 阿法玛公司 | Elastic composition comprising lichenic acid and the equipment by its preparation or coating |
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| CN105462261A (en) * | 2015-12-22 | 2016-04-06 | 合肥仲农生物科技有限公司 | Anti-infection nano composite material |
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| CN108158679A (en) * | 2017-12-25 | 2018-06-15 | 大连三生科技发展有限公司 | A kind of preparation method of complex implanted false teeth |
| CN108452418A (en) * | 2018-01-19 | 2018-08-28 | 广东药科大学 | A kind of tracheal catheter and its preparation method and application being loaded with antibacterial peptide MDC coatings |
| WO2019140796A1 (en) * | 2018-01-19 | 2019-07-25 | 广东药科大学 | Endotracheal tube loaded with antimicrobial peptide mdc coating and preparation method therefor and application thereof |
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