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CN101653635A - Manual tracheotomy tube with antibacterial nano material coating - Google Patents

Manual tracheotomy tube with antibacterial nano material coating Download PDF

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Publication number
CN101653635A
CN101653635A CN200910195041A CN200910195041A CN101653635A CN 101653635 A CN101653635 A CN 101653635A CN 200910195041 A CN200910195041 A CN 200910195041A CN 200910195041 A CN200910195041 A CN 200910195041A CN 101653635 A CN101653635 A CN 101653635A
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China
Prior art keywords
coating
silver
antibacterial
nano material
tracheostomy cannula
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CN200910195041A
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李文放
林兆奋
刘雪峰
张强
王虑
陈德昌
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Second Military Medical University SMMU
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Second Military Medical University SMMU
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Abstract

本发明涉及医疗器械技术领域。呼吸机相关性肺炎的发生是带有病原体的分泌物吸入的结果,其中呼吸机气路管道的细菌污染也是引起呼吸机相关性肺炎的一个重要因素。本发明的目的是提供一种具有广谱抗菌性能及可控缓释药物的人工气管切开套管,该气管切开套管包括柔性管体以及附于管体外的套囊系统,内外表面有机结合有高分子聚合物抗菌涂层,且在该表面涂层中负载入具有药理效果的药物。该发明不仅满足了传统气管切开套管提供气路,保持呼吸道通畅的功效,且具有优异的抑菌及可控药物缓释功效,为其临床应用提供了广阔应用前景。

Figure 200910195041

The invention relates to the technical field of medical instruments. The occurrence of ventilator-associated pneumonia is the result of inhalation of secretions with pathogens, and the bacterial contamination of the ventilator airway pipeline is also an important factor causing ventilator-associated pneumonia. The purpose of the present invention is to provide an artificial tracheostomy tube with broad-spectrum antibacterial properties and controlled release of drugs. The tracheotomy tube includes a flexible tube body and a cuff system attached to the outside of the tube. It is combined with a high molecular polymer antibacterial coating, and the drug with pharmacological effects is loaded into the surface coating. The invention not only satisfies the effect of traditional tracheostomy tubes in providing an air path and keeping the airway unobstructed, but also has excellent antibacterial and controlled drug release effects, which provides broad application prospects for its clinical application.

Figure 200910195041

Description

The artificial trachea of antibacterial nano material coating cuts sleeve pipe
Technical field
The present invention relates to technical field of medical instruments, is that a kind of artificial trachea of antibacterial nano material coating cuts sleeve pipe.
Background technology
Along with the raising of science and technology development and health of people consciousness, the application of biomaterial on clinical medicine also more and more widely.Still there is some problem in biomaterial bringing to clinical treatment easily simultaneously.No matter it is found that is long-term or short-term is retained in the intravital biomaterial of people, all usually can cause various bacterial infections.Infectious disease still accounts for 1/3 in the world population cause of the death at present, and ranks first with pneumonia, wherein especially with severe pneumonia serious threat human beings'health.Nosocomial Pneumonia (hospital acquired pneumonia, HAP) be that modal hospital acquired infects, China HAP accounts for the 1st hospital infection, prevalence 1.3%~3.45%, common and the most critical among the HAP is respirator dependency pneumonia (ventilation associated pneumonia, VAP), it is the pulmonary infection that patients with mechanical ventilation occurs after 48 hours in ventilation, its prevalence 9%~24%, case fatality rate 33%~71% has nearly 30% directly owing to respirator dependency pneumonia in the ICU death.
Respirator dependency pneumonia be to have the result that the secretions of pathogen sucks.Be colonizated in the interior antibacterial of respirator return and enter trachea along with the aerosol that sprays the formation of suction air-flow or by the condensed water refluence of polluting, and adhere to a large amount of antibacterials around tracheostomy cannula inwall and the air bag, very easily enter lower respiratory tract and cause respirator dependency pneumonia with secretions.For this reason, the germ contamination of respirator gas path pipe is as a key factor of respirator dependency pneumonia and be subjected to people's attention.
At present, the tracheostomy cannula of clinical use, zest is big, and antibiotic property is poor, easy infection.Once there was statistics to find that it is 9.84% that patient puts 2-5 days postoperative infection rates of pipe at tracheostomy cannula, putting 6-15 days infection rate of pipe is 39.46%, putting 16-30 days infection rate of pipe is 49.43%, substantially reached 100% (Chi Lizhuan, Wu Hengyi and put the infection rate of pipe above 30 days, whole nation severe infection control academic discussion, Shantou, 2000).
Along with the understanding that formation and respirator dependency pneumonia to the tracheostomy cannula biofilm concern, people expect to develop a kind of tracheostomy cannula with antibacterial functions, to reduce the generation of respirator dependency pneumonia.
China utility model patent CN01279721.9 provides a kind of antibiotic artificial trachea to cut sleeve pipe, by the infection-resisting high-molecular material preparation, inorganic or organic anti-infective and macromolecular material is prepared by compound, blend, thereby realizes the anti-infective purpose.
Summary of the invention
The purpose of this invention is to provide and a kind ofly can obtain satisfied antibacterial effect, suppress and the artificial trachea with broad spectrum antibacterial performance and controllable sustained-release medicine that reduces respirator dependency pneumonia incidence rate cuts sleeve pipe.
The artificial trachea that the invention provides a kind of antibacterial nano material coating cuts sleeve pipe, described sleeve pipe comprises the flexible pipe body with certain-length and invests the outer cover bag system of body, flexible pipe body has union joint and insertion end, inflatable cuff is enclosed within the outer surface to the insertion end of trachea body, the edge of inflatable cuff is tightly connected with giving the trachea body, also be connected with the charge/discharge gas pipe on the flexible pipe body, the charge/discharge gas pipe communicates with inflatable cuff, flexible pipe body opposite side tube wall is embedded with a discharging tube, discharging tube one end has a leakage fluid dram above air bag, the other end can link to each other with devices such as syringes; Described tracheostomy cannula surfaces externally and internally has the high molecular polymer antimicrobial coating, and load goes into to have the medicine of pharmacological effect in this face coat.
Described tracheostomy cannula surfaces externally and internally is covered with antibacterial nano material coating, and the thickness of antimicrobial coating is 0.1mm-1mm.
Described antibacterial nano material coating is mainly to be mixed by high molecular polymer, nano inorganic antimicrobial agent and slow releasing pharmaceutical; Described macromolecule polymer material comprises polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate esters polymer, polyvinyl alcohol, polyurethane, PMAm etc.; Described nano inorganic antimicrobial agent for silver ion be effective antipathogenic composition silver-based inorganic antibacterial agent, be the zine series inorganic germicide of effective antipathogenic composition, be in the anti-biotic materials such as copper based inorganic antibacterial agent of effective antipathogenic composition one or several with copper ion that with zinc ion the percentage by weight of nano inorganic antimicrobial agent in antibacterial nano material coating is 0.01%-10%; Described slow releasing pharmaceutical is respirator dependency pneumonia such as quinolones, cephalosporins, penicillins, aminoglycosides, glycopeptide antibacterials commonly used, and two or more mixture in them, the percentage by weight of described slow releasing pharmaceutical in antibacterial nano material coating is 0.01%-10%.
More excellent, macromolecule polymer material is polyvinylpyrrolidone PVP, PVP-vinyl acetate esters polymer; Nano inorganic antimicrobial agent is the nanometer-level silver based inorganic antibacterial agent, comprises the silver that simple substance silver, silver oxide, Silver monobromide, silver nitrate, silver sulfate, silver silicate or zeolite, zirconium phosphate etc. coat.
Slow releasing pharmaceutical is one or more hybrid medicines in the medicines such as piperacillin/Tazobactam Sodium compound formulation, ticarcillin/clavulanic acid compound formulation, cefoperazone/sulbactam compound formulation, imipenum/cilastatin compound formulation, Moxifloxacin, ciprofloxacin, meropenem, amikacin.
More excellent, the percentage by weight of nano inorganic antimicrobial agent in antibacterial nano material coating is 0.5%-5%; The percentage by weight of slow releasing pharmaceutical in antibacterial nano material coating is 0.5%-5%.
Raw material and processing technique that tracheostomy cannula of the present invention uses common medical macromolecular materials to prepare common tracheostomy cannula are made common medical tracheostomy cannula, apply the coating of high molecular polymer that one deck contains one or more nano anti-biotic materials at this tracheostomy cannula surfaces externally and internally again, and in coating, be written into slow releasing pharmaceutical with pharmacological effect, make antibiotic property nanometer tracheostomy cannula.Raw materials used strong but pliable in texture, avirulence, larynx, trachea etc. is organized non-stimulated, plastics that also do not cause allergic reaction or rubber, above-mentioned medical grade plastics can be medical grade polyvinylchloride, medical grade polyethylene or medical grade silicone rubber.
The present invention has a leakage fluid dram above air bag, link to each other with the discharging tube that is embedded in tracheostomy cannula one side pipe wall, be used for the periodic attraction of deposited liquid on the air bag is come out, prevent that secretions from entering lower respiratory tract, reduce the occurrence probability of respirator dependency pneumonia.
The present invention is by applying the coating of high molecular polymer material that one deck contains one or more nano anti-biotic materials at the tracheostomy cannula surfaces externally and internally, realize the bacteriostasis efficacy of this tracheostomy cannula, thereby improve the infection conditions of antibacterial in the mechanical ventilation process, reduce the consumption of incidence rate and the saving manpower and the material resources of respirator dependency pneumonia.
The present invention is implemented in the Failure Treated with Mechanical Ventilation process by be written into the pneumonia medicine in the nano-antibacterial coating, at bacteriostatic simultaneously, reaches the effect of controlled slow release medicine, plays the effect of treatment.After the carried medicine sustained-release body implants, can directly act on patient part, reach that dosage is few, local concentration is high, toxic and side effects is little, long action time and eutherapeutic effect.
The present invention adopts at original common tracheostomy cannula surface-coated nano anti-biotic material, reaches antibiotic effect, improves the technical scheme of the infection conditions of antibacterial in the therapeutic process, has excellent anti-microbial property on the one hand, the manufacturing process simple controllable is with low cost on the one hand, is fit to produce in batches.
Independent detection result of the present invention shows that it meets GB/T16886-1997 " medical apparatus and instruments biological assessment " requirement, has good serviceability.The every mechanical property of the present invention shows that it meets the requirement of tracheostomy cannula, satisfies and uses needs.Therefore the present invention has good reliability, the antibiotic time is long and broad-spectrum is antibiotic and advantage such as therapeutic effect.
Description of drawings
Fig. 1 is that the artificial trachea of antibacterial nano material coating of the present invention cuts telescopic vertical section structure sketch map
Wherein: 1 short limb, 2 flexible pipe bodies, 3 union joints, 4 valves, 5 charge/discharge gas pipes, 6 inflatable cuff, 7 insertion ends, 8 leakage fluid drams, 9 discharging tubes, 10 nano-antibacterial coatings (diagonal line hatches part), 11 discharging tube connectors
The specific embodiment
Below in conjunction with accompanying drawing to the invention will be further described with embodiment; present embodiment is being to implement under the prerequisite with the technical solution of the present invention; provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
Embodiment 1:
A kind of artificial trachea cuts sleeve pipe, is made up of flexible pipe body 2, charge/discharge gas pipe 5, inflatable cuff 6 and discharging tube 9.The two ends of flexible pipe body 2 are respectively union joint 3 and insertion end 7, and union joint 3 links to each other with respirator; Insertion end 7 links to each other with patient's trachea.Be provided with inflatable cuff 6 near the bottom of flexible pipe body 2 (insertion end 7).Charge/discharge gas pipe 5 vertically is embedded in the flexible pipe body 2 one side pipe walls, and charge/discharge gas pipe 5 is being drawn near short limb 1 and tracheostomy cannula junction, and valve 4 is installed at the critical point, can link to each other with aerating device.The cannula wall side opening of inflatable cuff 6 charge/discharge gas pipe 5 mouths of pipe interior with being embedded in the tracheostomy cannula wall are connected, and have the hole facing on the position of inflatable cuff 6 on the charge/discharge gas pipe 5, are used for inflatable cuff 6 inflations.Discharging tube 9 is embedded on the flexible pipe body 2 opposite side tube walls, and discharging tube 9 one ends have a leakage fluid dram 8 above aerating gasbag 6, and the other end has a discharging tube connector 11 to link to each other with devices such as syringes, and the liquid that is used for accumulating on the aerating gasbag regularly attracts out.Near the top of flexible pipe body (union joint) is provided with short limb 1, and short limb encloses fixedly tracheostomy cannula with cord around cervical region one.
The extrusion molding processing technique that this tracheostomy cannula uses common medical grade polyvinylchloride to prepare common tracheostomy cannula prepares, utilize double screw extruder, extrusion die, after antibiotic property master batch plasticizing extruded, in vacuum cooler, carry out cooling and shaping, pass through traction, cutting and assembling then, prepare the antibiotic property tracheostomy cannula tubing.
Embodiment 2:
With polyvinylpyrrolidone 6g, ticarcillin/clavulanic acid compound formulation 0.03g, zeolite with carrying silver antibacterial 0.3g, ethanol 100ml, dimethyl formamide 30ml, ethyl acetate 30ml, mix homogeneously, it is stand-by to be made into mixed solution;
The top artificial trachea that makes according to embodiment 1 method is cut sleeve pipe to be immersed in the mixed solution 1 minute, take out, dried about 5-10 minute down for 60-70 ℃, the artificial trachea that makes a kind of antibacterial nano material coating of the present invention cuts sleeve pipe, the thickness average out to 0.5mm of its coating 10.
Embodiment 3:
With polyvinylpyrrolidone 10g, cefoperazone/sulbactam compound formulation 0.1g, silver-loaded zirconium phosphate antibacterial 0.2g, ethanol 100ml, dimethyl formamide 40ml, ethyl acetate 30ml, acetone 10ml, mix homogeneously, wiring solution-forming is stand-by;
The top tracheostomy cannula that makes according to embodiment 1 method was immersed in the mixed solution 2 minutes, take out, dried about 5-10 minute down for 60-70 ℃, the artificial trachea that makes another kind of antibacterial nano material coating of the present invention cuts sleeve pipe, the thickness average out to 1mm of its coating 10.
Embodiment 4:
With polyvinylpyrrolidone 5g, ciprofloxacin 0.25g, zeolite with carrying silver antibacterial 0.025g, ethanol 100ml, dimethyl formamide 40ml, ethyl acetate 30ml, oxolane 20ml, wiring solution-forming is stand-by;
The top artificial trachea conduit that makes according to embodiment 1 method was immersed in the mixed solution 0.5 minute, take out, dried about 5-10 minute down for 60-70 ℃, the artificial trachea that makes another kind of antibacterial nano material coating of the present invention cuts sleeve pipe, the thickness average out to 0.3mm of its coating 10.

Claims (5)

1, a kind of artificial trachea of antibacterial nano material coating cuts sleeve pipe, comprise flexible pipe body and invest the outer cover bag system of body, flexible pipe body has union joint and insertion end, it is characterized in that inflatable cuff is enclosed within the outer surface to the insertion end of trachea body, the edge of inflatable cuff is tightly connected with giving the trachea body, also be connected with the charge/discharge gas pipe on the flexible pipe body, the charge/discharge gas pipe communicates with inflatable cuff, flexible pipe body opposite side tube wall is embedded with a discharging tube, discharging tube one end has a leakage fluid dram above air bag, the other end can link to each other with syringe; The surfaces externally and internally of this antibiotic property nanometer tracheostomy cannula is covered with antibacterial nano material coating, and this antibacterial nano material coating is mainly mixed by high molecular polymer, nano inorganic antimicrobial agent and slow releasing pharmaceutical, and the thickness of coating is 0.1mm-1mm;
The percentage by weight of described nano inorganic antimicrobial agent in coating is 0.01%-10%, and this nano inorganic antimicrobial agent is selected from following arbitrary or combination that both are above: with silver ion be effective antipathogenic composition silver-based inorganic antibacterial agent, be the zine series inorganic germicide of effective antipathogenic composition, be the copper based inorganic antibacterial agent of effective antipathogenic composition with copper ion with zinc ion;
The percentage by weight of described slow releasing pharmaceutical in coating is 0.01%-10%, and this slow releasing pharmaceutical is selected from following arbitrary or both above combinations: quinolones, cephalosporins, penicillins, aminoglycosides, glycopeptide medicine.
2, the tracheostomy cannula of a kind of antibacterial nano material coating according to claim 1 is characterized in that described macromolecule polymer material is polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate esters polymer, polyvinyl alcohol, polyurethane or PMAm.
3, the tracheostomy cannula of a kind of antibacterial nano material coating according to claim 1 is characterized in that the percentage by weight of nano inorganic antimicrobial agent in coating is 0.5%-5%; The percentage by weight of slow releasing pharmaceutical in coating is 0.5%-5%.
4, according to the tracheostomy cannula of claim 1,2 or 3 described a kind of antibacterial nano material coatings, it is characterized in that nano inorganic antimicrobial agent wherein is the silver of simple substance silver, silver oxide, Silver monobromide, silver nitrate, silver sulfate, silver silicate, zeolite coating, or the nanometer formulation of the silver of zirconium phosphate coating.
5,, it is characterized in that wherein slow releasing pharmaceutical is one or more the combination in piperacillin/Tazobactam Sodium compound formulation, ticarcillin/clavulanic acid compound formulation, cefoperazone/sulbactam compound formulation, imipenum/cilastatin compound formulation, Moxifloxacin, ciprofloxacin, meropenem, the amikacin according to the trachea tracheostomy cannula of claim 1,2 or 3 described a kind of antibacterial nano material coatings.
CN200910195041A 2009-09-03 2009-09-03 Manual tracheotomy tube with antibacterial nano material coating Pending CN101653635A (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102504318A (en) * 2011-11-15 2012-06-20 浙江中医药大学附属第一医院 Method for preparing efficient antibacterial tracheal intubation catheter
CN102631740A (en) * 2011-07-22 2012-08-15 湛江市事达实业有限公司 Sputum-suction trachea cannula, trachea cannula assembly and manufacturing method of trachea cannula
CN103110977A (en) * 2013-01-29 2013-05-22 爱宝骨科有限公司 Biodegradable copper-containing coating pure magnesium anastomosis nail and preparation method thereof
CN105999406A (en) * 2016-06-02 2016-10-12 温州医科大学 Method for preparing high-efficiency antibacterial quaternary ammonium salt chitosan composite gel coating layer
CN108837262A (en) * 2018-06-22 2018-11-20 江南大学附属医院 A kind of bronchial catheter with antibacterial functions
CN111249590A (en) * 2020-03-31 2020-06-09 中国人民解放军总医院 Disposable Laryngeal Snorkel
CN111265750A (en) * 2020-03-31 2020-06-12 中国人民解放军总医院 Air bag pressure indicating type larynx ventilating tube
CN113209438A (en) * 2021-04-27 2021-08-06 青岛大学附属医院 Anti-splashing device for tracheotomy
CN114425127A (en) * 2022-02-23 2022-05-03 山东百多安医疗器械股份有限公司 Disposable perianal abscess antibacterial drainage tube

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102631740A (en) * 2011-07-22 2012-08-15 湛江市事达实业有限公司 Sputum-suction trachea cannula, trachea cannula assembly and manufacturing method of trachea cannula
CN102504318A (en) * 2011-11-15 2012-06-20 浙江中医药大学附属第一医院 Method for preparing efficient antibacterial tracheal intubation catheter
CN102504318B (en) * 2011-11-15 2014-02-12 浙江中医药大学附属第一医院 A kind of preparation method of high-efficiency antibacterial endotracheal intubation catheter
CN103110977A (en) * 2013-01-29 2013-05-22 爱宝骨科有限公司 Biodegradable copper-containing coating pure magnesium anastomosis nail and preparation method thereof
CN103110977B (en) * 2013-01-29 2014-08-20 爱宝骨科有限公司 Biodegradable copper-containing coating pure magnesium anastomosis nail and preparation method thereof
CN105999406A (en) * 2016-06-02 2016-10-12 温州医科大学 Method for preparing high-efficiency antibacterial quaternary ammonium salt chitosan composite gel coating layer
CN108837262A (en) * 2018-06-22 2018-11-20 江南大学附属医院 A kind of bronchial catheter with antibacterial functions
CN111249590A (en) * 2020-03-31 2020-06-09 中国人民解放军总医院 Disposable Laryngeal Snorkel
CN111265750A (en) * 2020-03-31 2020-06-12 中国人民解放军总医院 Air bag pressure indicating type larynx ventilating tube
CN113209438A (en) * 2021-04-27 2021-08-06 青岛大学附属医院 Anti-splashing device for tracheotomy
CN114425127A (en) * 2022-02-23 2022-05-03 山东百多安医疗器械股份有限公司 Disposable perianal abscess antibacterial drainage tube
CN114425127B (en) * 2022-02-23 2023-10-20 山东百多安医疗器械股份有限公司 Disposable perianal abscess antibacterial drainage tube

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Application publication date: 20100224