面向组织工程化软组织的制造技术及增材制造简

背景：近年来,组织工程支架的制造方法众多,特别是增材制造技术因其独特的累积成型原理,为复杂软组织支架的高精度制造提供了高效、可靠的制造技术,也推动了大缺损软组织修复研究。 目的：总结近年来关于面向软组织支架的制造方法,对其进行简要的综述,并探讨其存在的问题与前景。 方法：应用计算机检索PubMed数据库及中国知网数据库2010年1月至2013年9月关于软组织支架的制造方法的文章,英文检索词为“additive manufacturing,microfabrication,vascular tissue engineering,muscle tissue engineering,cartilage tissue engineering,stereolithography,3D printing,biodegradable hydrogel”,中文检索词为“增材制造,微制造,血管组织工程,肌肉组织工程,软骨组织工程,光固化快速成型,三维打印技术,可降解水凝胶”。 结果与结论：软组织大块缺损支架的制造,已由简单平面结构向复杂三维转变,并考虑到软组织内部血管的作用,在制造过程中将软组织支架材料与细胞、生长因子结合,达到解决支架内部血管化的问题。增材制造技术为复杂形状的软组织活性支架的高精度制造提供了新的方法。水凝胶/细胞的构建是软组织支架的关键,而与之相关的高精度增材制造技术原理和制造工艺,以及水凝胶、细胞与生长因子的组装方法则是突破这一关键的核心技术。     

Coping with vaccine manufacturing delays

With production of influenza vaccine delayed this year, physicians must prioritize and vaccinate those at highest risk first. Antiviral drugs can reduce the duration of symptoms by 1 to 2 days but should not be the first-line strategy for prevention.     

Phototoxicity in an ultraviolet ink manufacturing plant

Ultraviolet (UV) dyes are used as inks in garment printing. Hypersensitivity reactions to these compounds have been reported in the literature. The authors report a case of reaction to UV ink in a patient already on corticosteroid therapy. The patient's clinical course was reviewed along with images of wounds that subsequently developed. The affected areas were debrided and covered with Vaseline gauze and silver impregnated dressings. Epithelium was salvaged in many areas, and regrowth occurred over several weeks in regions of deeper injury. The concurrent use of steroids and the rapidity of the onset of symptoms were not characteristic of hypersensitivity dermatitis, which has previously been reported. The cause of the wounds was likely phototoxicity from radical subtypes in the ink that catalyze the reaction when exposed to UV light.     

Current good manufacturing practices for transfusion medicine

Transfusion medicine is most tightly controlled in the US by CGMPs that are written as regulations, guidances, and quality management documents. Because the US regulatory scheme requires that each unit of human blood donated for transfusion (and other purposes) be documented from the moment of donor registration until the last component of that donation is finally disposed of, there is precious little that remains solely within the discretion of the treating physician who orders transfusions for her or his patients. An additional complication for transfusion medicine specialists is that the search for the requirements must extend to all possible areas of information, including the possibly unexpected source within the private sector.     

个性化外耳支架的设计与制造

目的:在耳郭重建手术中,目前国内外整形外科医生主要采用切取患者自体肋软骨,将其雕刻成为耳郭支架。或者采用进口的高密度多孔聚乙烯材料按健耳的大小和形状切削修整组装形成外耳支架。自体软骨支架的构建的外耳形状完全取决于整形外科医生的技术,而进口的高密度聚乙烯材料外耳的形状固定,无个性化。针对耳郭重建手术中外耳支架的构建难于与患者健侧耳郭较好匹配的问题,且基于医学CT影像技术和快速成形技术的迅速发展的基础上,探索一种新型构建外耳支架的设计与制造方法。方法:对患者健侧外耳的CT图像进行反求,通过图像分割、区域生长、图像开操作等方法,将耳郭组织与周围组织分开,利用三维重构设计出个性化的外耳支架的三维模型。然后采用熔融挤压快速成形技术制造出外耳支架。结果:①通过对患者健侧外耳的CT图像进行反求获得了耳郭的三维数据模型。②利用熔融挤压快速成形技术可制造出外形逼真且与健侧耳郭相对称的外耳支架。结论:由CT片层数据进行三维重构得到外耳的数据模型,用快速成形技术可得外耳实体模型,为耳郭重建手术提供一种新的方法。     

假肢接受腔计算机辅助设计与制造系统的研制

目的 :以假肢接受腔数学模型为模版 ,将临床经验结合当今高新技术 ,自动设计与制造假肢接受腔 ,造福残疾人。方法 :利用自主知识产权软件 ,将假肢接受腔的数学模型 ,以三维图形显示 ,并可进行各种修改 ,将数据转换成数控加工设备的控制代码输出。结果 :丰富了假肢接受腔设计理论 ,建立了适合中国人体型的假肢接受腔数学模型 ;建立了假肢接受腔辅助设计平台 ,实现了假肢接受腔计算机辅助设计与制造技术的集成。结论 :该系统是我国自行研制开发的第一套假肢接受腔计算机辅助设计与制造系统 ,该系统属国内首创 ,其主要性能指标达到国外同类产品水平     

A manufacturing system for contoured foam cushions.

The design, application and evaluation of a specialized, personal computer-based manufacturing system for contouring foam cushions is presented. The topics discussed include both the hardware configuration and the software design. The target applications of this device are local or centralized fabrication of custom-contoured seat cushions. Although the technologies used for the development and implementation of this system are not new, using a personal-computer-based (PC) controller in place of a stand-alone numerically controlled (NC) motion controller significantly reduced the cost associated with this component. Further reductions in cost resulted from an optimization of the mechanical configuration for the dedicated task of carving foam cushions.     

Application of lean manufacturing techniques in the Emergency Department

Background: “Lean” is a set of principles and techniques that drive organizations to continually add value to the product they deliver by enhancing process steps that are necessary, relevant, and valuable while eliminating those that fail to add value. Lean has been used in manufacturing for decades and has been associated with enhanced product quality and overall corporate success. Objectives: To evaluate whether the adoption of Lean principles by an Emergency Department (ED) improves the value of emergency care delivered. Methods: Beginning in December 2005, we implemented a variety of Lean techniques in an effort to enhance patient and staff satisfaction. The implementation followed a six-step process of Lean education, ED observation, patient flow analysis, process redesign, new process testing, and full implementation. Process redesign focused on generating improvement ideas from frontline workers across all departmental units. Value-based and operational outcome measures, including patient satisfaction, expense per patient, ED length of stay (LOS), and patient volume were compared for calendar year 2005 (pre-Lean) and periodically after 2006 (post-Lean). Results: Patient visits increased by 9.23% in 2006. Despite this increase, LOS decreased slightly and patient satisfaction increased significantly without raising the inflation adjusted cost per patient. Conclusions: Lean improved the value of the care we delivered to our patients. Generating and instituting ideas from our frontline providers have been the key to the success of our Lean program. Although Lean represents a fundamental change in the way we think of delivering care, the specific process changes we employed tended to be simple, small procedure modifications specific to our unique people, process, and place. We, therefore, believe that institutions or departments aspiring to adopt Lean should focus on the core principles of Lean rather than on emulating specific process changes made at other institutions.     

眼球摘除术后定制个性化义眼

目的：为眼球摘除Ⅰ期植入义眼座的患者定制个性化义眼，观察其临床效果。方法：选取2002-04／2005-10行眼球摘除手术Ⅰ期植入义眼座的65例患者（65眼），患眼结膜囊内置人眼模，2周后参照健眼特征定制个性化义眼。测量患者配戴个性化义眼后双侧睑裂高度、眼球突出度、义眼水平及垂直方向活动度。就个性化义眼的颜色、外形、活动性、固位性及舒适性5个主要指标按满意、基本满意、不满意3级分别向患者征询意见。结果：按意向处理分析，实验纳入行眼球摘除手术Ⅰ期植入义眼座的65例患者，共65眼，全部进入结果分析。①个性化义眼大体形态观察：个性化义眼的质量为1．7-2．4g，平均（2．1&;#177;0．3）g。中央厚度为4．0-5．1mm，平均（4．5i-0．4）mm。②患者配戴个性化义眼后外观各项指标评价：患者双侧睑裂高度、眼球突出度无显著性差异（t=2．147，2．308，P〉0．05）；义眼水平方向活动度20&;#176;-35&;#176;，平均（28．2&;#177;5．4）&;#176;；垂直方向活动度150～25&;#176;，平均（20．3&;#177;4．1）&;#176;。③患者配戴定制义眼后各项指标满意度调查结果：患者对个性化义眼外形、颜色、活动性、固位性、舒适性评价总满意率（满意和基本满意）分别为90．8％，86．2％，76．7％，96．9％，87．7％。④患者配戴个性化义眼引起的并发症情况：出现眼胀不适感7例（10．8％），巨乳头性结膜炎4例（6．2%）。结论：对于眼球摘除义眼座植入术后的患者，根据患眼结膜囊形态取模，并参照健眼特征定制个性化义眼，可获得较好的仿真效果，具有临床应用与推广价值。     

眼球摘除术后定制个性化义眼

目的:为眼球摘除Ⅰ期植入义眼座的患者定制个性化义眼,观察其临床效果。方法:选取2002-04/2005-10行眼球摘除手术Ⅰ期植入义眼座的65例患者(65眼),患眼结膜囊内置入眼模,2周后参照健眼特征定制个性化义眼。测量患者配戴个性化义眼后双侧睑裂高度、眼球突出度、义眼水平及垂直方向活动度。就个性化义眼的颜色、外形、活动性、固位性及舒适性5个主要指标按满意、基本满意、不满意3级分别向患者征询意见。结果:按意向处理分析,实验纳入行眼球摘除手术Ⅰ期植入义眼座的65例患者,共65眼,全部进入结果分析。①个性化义眼大体形态观察:个性化义眼的质量为1.7～2.4g,平均(2.1±0.3)g。中央厚度为4.0～5.1mm,平均(4.5±0.4)mm。②患者配戴个性化义眼后外观各项指标评价:患者双侧睑裂高度、眼球突出度无显著性差异(t=2.147,2.308,P>0.05);义眼水平方向活动度20°～35°,平均(28.2±5.4)°;垂直方向活动度15°～25°,平均(20.3±4.1)°。③患者配戴定制义眼后各项指标满意度调查结果:患者对个性化义眼外形、颜色、活动性、固位性、舒适性评价总满意率(满意和基本满意)分别为90.8%,86.2%,76.7%,96.9%,87.7%。④患者配戴个性化义眼引起的并发症情况:出现眼胀不适感7例(10.8%),巨乳头性结膜炎4例(6.2%)。结论:对于眼球摘除义眼座植入术后的患者,根据患眼结膜囊形态取模,并参照健眼特征定制个性化义眼,可获得较好的仿真效果,具有临床应用与推广价值。     

Elimination of bagassosis in Louisiana paper manufacturing plant workers

The prevalence of bagassosis was investigated in a Louisiana paper mill, which in the past had considerable numbers of workers with the disease. Based on negative clinical histories and the low number of positive serological reactions of the workers' serum with Thermoactinomyces sacchari antigen, it was concluded that bagassosis was no longer present. This was thought to be due to a different method of storage of bagasse, which retards microbial decay and reduces airborne organic dust, and to the increased awareness of plant management resulting in greater safety measures.     

Incontinence in a manufacturing setting: women's perceptions and responses

The true prevalence of urinary incontinence (UI) and its impact on the quality of life in working women are not well established. Many women do not report UI to a health care provider because they mistakenly believe UI is a natural part of aging. This situation exists despite the dissemination of a national guideline for UI in adults. The aims of this study were to (1) explore what incontinent women in a manufacturing setting name or identify as the proposed cause of urinary leakage (2) analyze an association between identifying a UI cause and reporting it to a health care provider and (3) determine how many women were aware of the AHCPR Guideline. The results indicate that the majority of incontinent women (62%) have not reported this to a health care provider. Most women attributed urinary leakage to parity and waiting too long to empty the bladder. There was no relationship between identifying a UI cause and reporting it to a health care provider. Only 2 of the women out of 78 had heard of the AHCPR Guideline but the majority of women wanted more information about UI (85%). Mechanisms are suggested for querying women with UI and disseminating the AHCPR Guideline.     

Drug flow. Good manufacturing practices, good clinical practices

On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels).     

Good manufacturing practices production of mesenchymal stem/stromal cells

Because of their multi/pluripotency and immunosuppressive properties mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs has led to production processes that need to be in accordance with Good Manufacturing Practice (GMP). In cellular therapy, safety remains one of the main concerns and refers to donor validation, choice of starting material, processes, and the controls used, not only at the batch release level but also during the development of processes. The culture processes should be reproducible, robust, and efficient. Moreover, they should be adapted to closed systems that are easy to use. Implementing controls during the manufacturing of clinical-grade MSCs is essential. The controls should ensure microbiological safety but also avoid potential side effects linked to genomic instability driving transformation and senescence or decrease of cell functions (immunoregulation, differentiation potential). In this rapidly evolving field, a new approach to controls is needed.