臭氧对医用海绵材料及半透膜材料的理化性能的影响
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摘要
背景：负压创面治疗技术(negative pressure Wound therapy, NPWT)是近些年来兴起的一种加快患者伤口愈合的新型方法。在实际应用中,先用医用海绵包裹多侧孔引流管,再用半透性粘贴薄膜(半透膜)封闭引流外口或引流伤口区,接通负压源,就组成了高效引流系统。NPWT所用的医用海绵主要有聚氨酯PU (Polyurethane)和聚乙烯醇酯PVA (Polyvinyl alcohol)海绵两种。NPWT可以早期将开放伤口变为闭合伤口,使病灶与外界隔绝,保持局部呈密封负压状态,阻止外部细菌侵入；由于海绵敷料在持续负压引流下,不易堵孔,形成由创面向敷料的缓慢液体流动,渗出的组织液经过敷料过滤后,有活力吸附于组织上的组织细胞被保留,而失去活力的组织细胞及组织液等废物通过硅胶管被吸出,从而减少细菌存活、繁殖的培养基。可即时引流出病灶渗出物,消灭死腔,清除血肿；在强负压作用下,病灶区血供明显增加,肉芽组织生长明显。同时,臭氧消毒灭菌是急速的,消毒作用在瞬间发生。已经广泛应用于临床,如空气消毒,宫腔感染,牙科的感染治疗等；但是臭氧对人体特别是呼吸道有毒害,因此需要研制密闭系统来避免泄露,避免使用过程中中毒事件的发生。根据以上两点我们提出了臭氧负压创面治疗(Ozone Negative Pressure Wound Therapy, ONPWT)的设想：认为密闭负压吸引可以短期内替代皮肤组织的覆盖；可以短期密闭隔绝空气污染,减少了交叉感染机会；加快感染创面坏死组织脱落,减少分泌物,有效控制感染,促进肉芽生长及创面愈合。创面覆盖的同时使用臭氧作为杀菌剂,避免创面感染；同时杀灭感染创面的有害微生物,改善创面供氧,促进创面愈合。但是臭氧具有强氧化性和腐蚀性,除了金和铂外,臭氧几乎对所有的金属都有腐蚀作用,对海绵和半透膜材料也有腐蚀作用,因此需要选择抗臭氧氧化并且组织相容性好的材料,应用在臭氧密闭负压吸引系统中。
目的：研究不同浓度臭氧水对医用海绵材料及薄膜材料的物理化学性能的影响,寻找能够耐受臭氧的海绵和薄膜材料。
方法：本研究分三部分。
第一部分：选择聚氨酯医用海绵(上海盈郎科技有限公司)和聚乙烯醇医用海绵(武汉维斯第医用科技有限公司)。建立体外臭氧负压冲洗模型,将海绵材料放置在玻璃板上,两端分别留置冲洗管和吸引管,使用英国S&N公司生产的安舒妥透明薄膜封闭密封固定海绵于玻璃板上,冲洗管接自制臭氧水发生器,引流管接于负压吸引装置。不同浓度臭氧水冲洗不同时间:5min,20min,40min,检测冲洗前后海绵材料的性能。根据GB/T 6344-2008标准,使用WDW-10电子式万能试验机测试臭氧水冲洗前后海绵的物理性能(包括拉伸过程最大载荷、试样断裂瞬间间距)。使用激光拉曼光谱分析测试冲洗前后光谱的变化,分析海绵的化学结构有无变化。
第二部分：选择英国S&N公司的安舒妥半透膜,建立体外臭氧负压冲洗模型,将海绵材料放置在玻璃板上,两端分别留置冲洗管和吸引管,使用安舒妥透明薄膜封闭密封固定海绵于玻璃板上,冲洗管接自制臭氧水发生器,引流管接于负压吸引装置。不同浓度臭氧水冲洗不同时间,检测冲洗前后薄膜材料的性能。根据GB/T 16578-1996标准,测试薄膜的抗撕裂性能。使用激光拉曼光谱分析测试冲洗前后光谱的变化,分析薄膜化学结构有无变化。
第三部分：建立体外臭氧负压冲洗模型,4mg/L臭氧水灌注后,放置5min,10mmin,15min后,将臭氧水吸出,测定臭氧水浓度的时间变化。
结果：
第一部分：4mg/L的臭氧水冲洗20min或者10mg的臭氧水冲洗5min,聚氨酯医用海绵的物理性能没有变化。4mg/L的臭氧水冲洗40min；10mg的臭氧水冲洗20min；30mg/L氧水冲洗5min,聚乙烯醇医用海绵物理性能(包括拉伸过程最大载荷、试样断裂瞬间间距)没有变化。激光拉曼光谱分析提示臭氧冲洗前后两种海绵材料没有新的基团形成,其化学结构均没有变化。
第二部分：根据GB/T 16578-1996标准测试的冲洗前后薄膜的负荷-位移曲线无明显变化。激光拉曼光谱分析提示臭氧冲洗前后薄膜材料没有新的基团形成,其化学结构均没有变化。
第三部分：密闭环境下,随着时间的延长,臭氧水浓度会有相应的降低,15分钟后,臭氧水浓度分别是0.32mg/L和0.29mg/L。
结论：
聚氨酯医用海绵、聚乙烯醇医用海绵以及半透膜均能耐受臭氧的作用,均可以应用于臭氧负压治疗系统。两种海绵比较,聚乙烯醇医用海绵的性能优于聚氨酯医用海绵。S&N公司的安舒妥半透膜的臭氧冲洗前后,抗撕裂性能无明显变化；超高浓度臭氧水冲洗2小时后,其微孔的孔径增大。臭氧水在密闭环境下,浓度随时间的延长有所降低,15分钟后仍然具有杀菌能力。
Background:Negative pressure Wound therapy (NPWT) is a efficacious wound treatment that applies negative pressure to the wound bed to promote healing in acute and chronic wounds. In practice, NPWT technique involves using a polyurethane (PU) or polyvinyl alcohol(PVA) foam dressing as a wound interface layer, placing multi-side hole drainage tube, and covering it with a semipermeable membrane to create an air-tight seal. On formation of an efficient drainage system, multi-side hole drainage tube was connected to vacuum pump. All of these studies demonstrated that NPWT early closured wound, maintained vacuum state, and reduced the bacterial burden of wounds. NPWT promotes maximum tissue in growth and facilitates the extraction of fluid from the wound. The open cell design allows all pores in the foam to communicate. NPWT applied to a wound surface has been demonstrated to have the following micro and macro-mechanisms of action:increases local blood flow to wounds; reduces edema; stimulates formation of granulation tissue; stimulates cell proliferation; reduces cytokines and matrix metalloproteinases; reduces bacterial load; draws wound edges together. Effect of disinfection and sterilization of ozone can occur in an instant, and use widely in clinical experience, such as air disinfection, uterine infections treatment, dental infections treatment, etc. But because of toxic effects of ozone in human, especially respiratory toxin when exposed repeatedly, closure system should be developed in order to avoid toxic effects. Professor CAI Jinfang propose innovative concept of ozone negative pressure wound therapy (ONPWT):NPWT can be short-term alternative to soft tissue's coverage; be isolated from air; reduce opportunities for cross-infection; accelerate shedding of necrotic tissue of infection wound; reduce secretions; effective control of infection; promote growth of granulation and wound healing. At the same time, ozone can be used as a fungicide to kill harmful micro-organisms to prevent wound infections; improve wound oxygen pressure and promote wound healing. Ozone has strong oxidizing and corrosive effect, and almost has a corrosive effect on all metals, in addition to gold and platinum. Foam and semipermeable membrane also can be eroded. So we have to select anti-ozone oxidation and histocompatibility good material, used to design ONPWT.
Purpose:To studies ozone oxidant Effect on medical foam and semipermeable membrane, in order to find appropriate antioxidant foam and membrane.
Methods:the study included three parts.
Part I:Selected medical PU foam (Shanghai Ying Lang Science&Technology Co., Ltd.) and medical PVA foam (Wuhan VSD Medical Science&Technology Co., Ltd.). Establishment of ozone water rinse vacuum model in vitro:placing foam on the glass, indwelling rinse tube and suction tube on both sides, sealing and fixing foam on the glass by using semipermeable membrane, connecting rinse tube to ozone water generator, connecting suction tube to suction device, irrigation through rinse tube using different concentrations of ozone water at 5min,20min, and 40min. And then we tested physical properties of foam before and after irrigation according to GB/T 6344-2008 standard, using WDW-10 electronic universal testing machine (including the maximum load of the drawing process, the instantaneous distance when sample torn), and tested the chemical structure of foam before and after irrigation using of laser Raman spectroscopy.
PartⅡ:Selected semipermeable membrane (Smith&nephew). Establishment of ozone water rinse vacuum model in vitro:placing foam on the glass, indwelling rinse tube and suction tube on both sides, sealing and fixing foam on the glass by using semipermeable membrane, connecting rinse tube to ozone water generator, connecting suction tube to suction device, irrigation through rinse tube using different concentrations of ozone water at different time. And then we tested physical properties of semipermeable membrane before and after irrigation according to GB/T 16578-1996 standard, using WDW-10 electronic universal testing machine, and tested the chemical structure of semipermeable membrane before and after irrigation using of laser Raman spectroscopy.
PartⅢ:Establishment of ozone water rinse vacuum model in vitro, irrigation with 4mg/L ozone water, sucking out the ozone water after 5min, 10min, and 15min, and measuring the concentration of it.
Results:
Part I:Part I:When using 4mg/L of ozone water rinse 20min or 10mg/L rinse 5min, the physical properties of PU foam medical unchanged. When 4mg/L rinse 40min; 10mg/L rinse 20min; 30mg/L rinse 5min, the physical properties of PVA foam(including the maximum load of the drawing process, the instantaneous distance when sample torn) has not changed. Laser Raman spectroscopy of two kinds of foam before and after irrigation showed that their chemical structures were not changed.
Part II:according to GB/T 16578-1996 standard, load-displacement curve of semipermeable membrane had no significant changes. Laser Raman spectroscopy of membrane before and after irrigation showed that chemical structures were not changed.
Part III:ozone water concentration will be reduced accordingly in ONPWT systems, which however still has bactericidal ability.
Conclusions:
Medical polyurethane foam, polyvinyl alcohol foam, as well as medical semi-permeable membrane can endure oxidant effect of ozone, which can be applied to ONPWT. The performance of PVA foam is better than PU foam. Tear resistance was not changed before and after irrigation. However, with the irrigation time extending, porous aperture of semi-permeable membrane increases, which reduce its function of isolating bacteria from the outside.
目的：研究不同浓度臭氧水对医用海绵材料及薄膜材料的物理化学性能的影响,寻找能够耐受臭氧的海绵和薄膜材料。
方法：本研究分三部分。
第一部分：选择聚氨酯医用海绵(上海盈郎科技有限公司)和聚乙烯醇医用海绵(武汉维斯第医用科技有限公司)。建立体外臭氧负压冲洗模型,将海绵材料放置在玻璃板上,两端分别留置冲洗管和吸引管,使用英国S&N公司生产的安舒妥透明薄膜封闭密封固定海绵于玻璃板上,冲洗管接自制臭氧水发生器,引流管接于负压吸引装置。不同浓度臭氧水冲洗不同时间:5min,20min,40min,检测冲洗前后海绵材料的性能。根据GB/T 6344-2008标准,使用WDW-10电子式万能试验机测试臭氧水冲洗前后海绵的物理性能(包括拉伸过程最大载荷、试样断裂瞬间间距)。使用激光拉曼光谱分析测试冲洗前后光谱的变化,分析海绵的化学结构有无变化。
第二部分：选择英国S&N公司的安舒妥半透膜,建立体外臭氧负压冲洗模型,将海绵材料放置在玻璃板上,两端分别留置冲洗管和吸引管,使用安舒妥透明薄膜封闭密封固定海绵于玻璃板上,冲洗管接自制臭氧水发生器,引流管接于负压吸引装置。不同浓度臭氧水冲洗不同时间,检测冲洗前后薄膜材料的性能。根据GB/T 16578-1996标准,测试薄膜的抗撕裂性能。使用激光拉曼光谱分析测试冲洗前后光谱的变化,分析薄膜化学结构有无变化。
第三部分：建立体外臭氧负压冲洗模型,4mg/L臭氧水灌注后,放置5min,10mmin,15min后,将臭氧水吸出,测定臭氧水浓度的时间变化。
结果：
第一部分：4mg/L的臭氧水冲洗20min或者10mg的臭氧水冲洗5min,聚氨酯医用海绵的物理性能没有变化。4mg/L的臭氧水冲洗40min；10mg的臭氧水冲洗20min；30mg/L氧水冲洗5min,聚乙烯醇医用海绵物理性能(包括拉伸过程最大载荷、试样断裂瞬间间距)没有变化。激光拉曼光谱分析提示臭氧冲洗前后两种海绵材料没有新的基团形成,其化学结构均没有变化。
第二部分：根据GB/T 16578-1996标准测试的冲洗前后薄膜的负荷-位移曲线无明显变化。激光拉曼光谱分析提示臭氧冲洗前后薄膜材料没有新的基团形成,其化学结构均没有变化。
第三部分：密闭环境下,随着时间的延长,臭氧水浓度会有相应的降低,15分钟后,臭氧水浓度分别是0.32mg/L和0.29mg/L。
结论：
聚氨酯医用海绵、聚乙烯醇医用海绵以及半透膜均能耐受臭氧的作用,均可以应用于臭氧负压治疗系统。两种海绵比较,聚乙烯醇医用海绵的性能优于聚氨酯医用海绵。S&N公司的安舒妥半透膜的臭氧冲洗前后,抗撕裂性能无明显变化；超高浓度臭氧水冲洗2小时后,其微孔的孔径增大。臭氧水在密闭环境下,浓度随时间的延长有所降低,15分钟后仍然具有杀菌能力。
Background:Negative pressure Wound therapy (NPWT) is a efficacious wound treatment that applies negative pressure to the wound bed to promote healing in acute and chronic wounds. In practice, NPWT technique involves using a polyurethane (PU) or polyvinyl alcohol(PVA) foam dressing as a wound interface layer, placing multi-side hole drainage tube, and covering it with a semipermeable membrane to create an air-tight seal. On formation of an efficient drainage system, multi-side hole drainage tube was connected to vacuum pump. All of these studies demonstrated that NPWT early closured wound, maintained vacuum state, and reduced the bacterial burden of wounds. NPWT promotes maximum tissue in growth and facilitates the extraction of fluid from the wound. The open cell design allows all pores in the foam to communicate. NPWT applied to a wound surface has been demonstrated to have the following micro and macro-mechanisms of action:increases local blood flow to wounds; reduces edema; stimulates formation of granulation tissue; stimulates cell proliferation; reduces cytokines and matrix metalloproteinases; reduces bacterial load; draws wound edges together. Effect of disinfection and sterilization of ozone can occur in an instant, and use widely in clinical experience, such as air disinfection, uterine infections treatment, dental infections treatment, etc. But because of toxic effects of ozone in human, especially respiratory toxin when exposed repeatedly, closure system should be developed in order to avoid toxic effects. Professor CAI Jinfang propose innovative concept of ozone negative pressure wound therapy (ONPWT):NPWT can be short-term alternative to soft tissue's coverage; be isolated from air; reduce opportunities for cross-infection; accelerate shedding of necrotic tissue of infection wound; reduce secretions; effective control of infection; promote growth of granulation and wound healing. At the same time, ozone can be used as a fungicide to kill harmful micro-organisms to prevent wound infections; improve wound oxygen pressure and promote wound healing. Ozone has strong oxidizing and corrosive effect, and almost has a corrosive effect on all metals, in addition to gold and platinum. Foam and semipermeable membrane also can be eroded. So we have to select anti-ozone oxidation and histocompatibility good material, used to design ONPWT.
Purpose:To studies ozone oxidant Effect on medical foam and semipermeable membrane, in order to find appropriate antioxidant foam and membrane.
Methods:the study included three parts.
Part I:Selected medical PU foam (Shanghai Ying Lang Science&Technology Co., Ltd.) and medical PVA foam (Wuhan VSD Medical Science&Technology Co., Ltd.). Establishment of ozone water rinse vacuum model in vitro:placing foam on the glass, indwelling rinse tube and suction tube on both sides, sealing and fixing foam on the glass by using semipermeable membrane, connecting rinse tube to ozone water generator, connecting suction tube to suction device, irrigation through rinse tube using different concentrations of ozone water at 5min,20min, and 40min. And then we tested physical properties of foam before and after irrigation according to GB/T 6344-2008 standard, using WDW-10 electronic universal testing machine (including the maximum load of the drawing process, the instantaneous distance when sample torn), and tested the chemical structure of foam before and after irrigation using of laser Raman spectroscopy.
PartⅡ:Selected semipermeable membrane (Smith&nephew). Establishment of ozone water rinse vacuum model in vitro:placing foam on the glass, indwelling rinse tube and suction tube on both sides, sealing and fixing foam on the glass by using semipermeable membrane, connecting rinse tube to ozone water generator, connecting suction tube to suction device, irrigation through rinse tube using different concentrations of ozone water at different time. And then we tested physical properties of semipermeable membrane before and after irrigation according to GB/T 16578-1996 standard, using WDW-10 electronic universal testing machine, and tested the chemical structure of semipermeable membrane before and after irrigation using of laser Raman spectroscopy.
PartⅢ:Establishment of ozone water rinse vacuum model in vitro, irrigation with 4mg/L ozone water, sucking out the ozone water after 5min, 10min, and 15min, and measuring the concentration of it.
Results:
Part I:Part I:When using 4mg/L of ozone water rinse 20min or 10mg/L rinse 5min, the physical properties of PU foam medical unchanged. When 4mg/L rinse 40min; 10mg/L rinse 20min; 30mg/L rinse 5min, the physical properties of PVA foam(including the maximum load of the drawing process, the instantaneous distance when sample torn) has not changed. Laser Raman spectroscopy of two kinds of foam before and after irrigation showed that their chemical structures were not changed.
Part II:according to GB/T 16578-1996 standard, load-displacement curve of semipermeable membrane had no significant changes. Laser Raman spectroscopy of membrane before and after irrigation showed that chemical structures were not changed.
Part III:ozone water concentration will be reduced accordingly in ONPWT systems, which however still has bactericidal ability.
Conclusions:
Medical polyurethane foam, polyvinyl alcohol foam, as well as medical semi-permeable membrane can endure oxidant effect of ozone, which can be applied to ONPWT. The performance of PVA foam is better than PU foam. Tear resistance was not changed before and after irrigation. However, with the irrigation time extending, porous aperture of semi-permeable membrane increases, which reduce its function of isolating bacteria from the outside.
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