Use of Diamond-Like Carbon Coatings to Reduce Leachables From Biomedical Metal Alloys and Polymeric Materials
使用类金刚石碳涂层减少生物医学金属合金和聚合物材料中的浸出物
基本信息
- 批准号:1836767
- 负责人:
- 金额:$ 10万
- 依托单位:
- 依托单位国家:美国
- 项目类别:Standard Grant
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-08-15 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
The Food & Drug Administration (FDA) requires that manufacturers assure the safety of medical devices or products that contact body tissues/fluids. Therefore, it is vital to minimize the release of chemical species, commonly known as leachables and extractables, from medical devices. The presence of these species may be due not only to the chemical composition of the materials, but also from manufacturing processes. Leachables and extractables from medical device biomaterials may have a significant impact on biocompatibility and may pose significant risks to patient health. This project will minimize the release of leachables from several classes of common biomaterials, including (a) polyvinylchloride (used in intravenous tubing and blood storage bags), (b) additively manufactured polyetheretherketone (used in bone implants), and (c) nickel-titanium shape memory alloy (used in cardiovascular stents for vessel patency), by depositing hydrogenated diamond-like carbon (DLC) coatings on the surfaces of these materials. DLC is a material made up entirely of carbon atoms, it can serve as a cell-friendly permeation barrier that prevents the release of leachables. This inexpensive technology has been utilized to prevent oxygen permeation in the bottled beverage industry. A DLC coating that would be chemically-amenable on polymers or metal alloys used in medical devices would reduce leachable-associated health risks across many classes of materials.The project has three aims. Aim 1: Deposition of DLC coatings on model biomaterials using plasma enhanced physical vapor deposition and physico-chemical characterization of the coatings. Scanning electron microscopy will be used to confirm the absence of pinholes in the coating, to confirm the coating thickness, and to evaluate the surface morphology. Aim 2: Chemical characterization and toxicological risk assessment of extractables and leachables from uncoated and DLC-coated biomaterials under physiologic and worst-case conditions. The milestone for this deliverable will be a comparison of the release of extractables and leachables from the DLC coated materials compared to uncoated materials. A toxicologic hazard identification assessment will be conducted to determine if any of the materials pose a toxicological risk. Aim 3: Biocompatibility testing of extractables/leachables from coated and uncoated/DLC-coated biomaterials using in vitro assays. The extractables and leachables from both uncoated and DLC-coated biomaterials will be used to treat mammalian cells in vitro for assessment of cell viability, reactive oxygen species (ROS) production, and pro-inflammatory cell markers. The goal is to confirm if DLC coatings reduce extractables/leachables from biomaterials that are commonly used in medical devices. If the proposed project is successful, the medical device industry will have a material (DLC) for application to a wide variety of metals and polymers.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
美国食品药品监督管理局(FDA)要求制造商确保接触人体组织/体液的医疗器械或产品的安全性。因此,最大限度地减少医疗器械中化学物质(通常称为可降解物和可浸提物)的释放至关重要。这些物质的存在不仅可能是由于材料的化学成分,也可能是由于制造过程。医疗器械生物材料的沥滤物和浸提物可能对生物相容性产生重大影响,并可能对患者健康构成重大风险。该项目将最大限度地减少几类常见生物材料中可降解物质的释放,包括(a)聚氯乙烯(用于静脉内管和血液储存袋),(B)增材制造的聚醚醚酮(用于骨植入物)和(c)镍钛形状记忆合金(用于血管通畅性的心血管支架),通过在这些材料的表面上沉积氢化类金刚石(DLC)涂层。DLC是一种完全由碳原子组成的材料,它可以作为一种细胞友好的渗透屏障,防止可降解物质的释放。这种廉价的技术已被用于防止瓶装饮料工业中的氧气渗透。在医疗器械中使用的聚合物或金属合金上具有化学稳定性的DLC涂层将降低许多类别材料的可降解相关健康风险。该项目有三个目标。目标1:使用等离子体增强物理气相沉积在模型生物材料上沉积DLC涂层和涂层的物理化学表征。将使用扫描电子显微镜确认涂层中无针孔,确认涂层厚度,并评价表面形态。目标二:生理和最差情况条件下无涂层和DLC涂层生物材料的浸提物和可浸提物的化学表征和毒理学风险评定。该可交付成果的里程碑将是比较DLC涂层材料与无涂层材料的可浸提物和可挥发物释放。将进行毒理学危害识别评估,以确定任何材料是否构成毒理学风险。目的3:使用体外试验对涂层和未涂层/DLC涂层生物材料的浸提物/可浸提物进行生物相容性试验。未涂层和DLC涂层生物材料的浸提物和可浸提物将用于体外处理哺乳动物细胞,以评估细胞活力、活性氧(ROS)产生和促炎细胞标志物。目的是确认DLC涂层是否减少了医疗器械中常用生物材料的可浸提物/可降解物。如果该项目获得成功,医疗器械行业将拥有一种可应用于各种金属和聚合物的材料(DLC)。该奖项反映了NSF的法定使命,并通过使用基金会的知识价值和更广泛的影响审查标准进行评估,被认为值得支持。
项目成果
期刊论文数量(9)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Antifungal behavior of silicon‐incorporated diamond‐like carbon by tuning surface hydrophobicity with plasma treatment
通过等离子体处理调节表面疏水性,硅掺入类金刚石碳的抗真菌行为
- DOI:10.1111/ijac.14048
- 发表时间:2022
- 期刊:
- 影响因子:2.1
- 作者:Yang, Kai‐Hung;Riley, Parand;Rodenhausen, Keith B.;Skoog, Shelby A.;Stafslien, Shane J.;Vanderwal, Lyndsi;Narayan, Roger J.
- 通讯作者:Narayan, Roger J.
Excimer Laser Patterned Holey Graphene Oxide Films for Nonenzymatic Electrochemical Sensing
- DOI:10.1021/acsami.2c09096
- 发表时间:2022-08-17
- 期刊:
- 影响因子:9.5
- 作者:Joshi, Pratik;Shukla, Shubhangi;Narayan, Roger
- 通讯作者:Narayan, Roger
Correlation of zeta potential and contact angle of oxygen and fluorine terminated nitrogen incorporated ultrananocrystalline diamond (N-UNCD) thin films
氧和氟封端氮掺入超纳米晶金刚石 (N-UNCD) 薄膜的 Zeta 电位与接触角的相关性
- DOI:10.1016/j.matlet.2021.129823
- 发表时间:2021
- 期刊:
- 影响因子:3
- 作者:Yang, Kai-Hung;Joshi, Pratik;Rodenhausen, Keith B.;Sumant, Anirudha V.;Skoog, Shelby A.;Narayan, Roger J.
- 通讯作者:Narayan, Roger J.
Synthesis and novel properties of Q-silicon (January 2023)
Q-硅的合成和新特性(2023年1月)
- DOI:10.1080/21663831.2023.2224396
- 发表时间:2023
- 期刊:
- 影响因子:8.3
- 作者:Narayan, Jagdish;Sundar Sahoo, Siba;Joshi, Naveen;Narayan, Roger
- 通讯作者:Narayan, Roger
Effect of oxygen and fluorine plasma surface treatment of silicon‐incorporated diamond‐like carbon coatings on cellular responses of mouse fibroblasts
氧和氟等离子体表面处理硅掺金刚石类碳涂层对小鼠成纤维细胞反应的影响
- DOI:10.1111/ijac.14107
- 发表时间:2022
- 期刊:
- 影响因子:2.1
- 作者:Riley, Parand R.;Yang, Kai‐Hung;Liu, Yizhong;Skoog, Shelby A.;Narayan, Jagdish;Narayan, Roger J.
- 通讯作者:Narayan, Roger J.
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Roger Narayan其他文献
Recent advances of boron-doped diamond electrochemical sensors toward environmental applications
- DOI:
10.1016/j.coelec.2021.100920 - 发表时间:
2022-04-01 - 期刊:
- 影响因子:6.900
- 作者:
Pratik Joshi;Parand Riley;K.Yugender Goud;Rupesh K. Mishra;Roger Narayan - 通讯作者:
Roger Narayan
Recent Developments in Electronic, Functional, and Biological Thin Films
- DOI:
10.1007/s11837-012-0303-7 - 发表时间:
2012-03-23 - 期刊:
- 影响因子:2.300
- 作者:
Roger Narayan - 通讯作者:
Roger Narayan
Laser-assisted formation of 3c-SiC and continuous diamond growth using Si–Q carbon on (100) silicon
激光辅助形成 3c-SiC 以及使用 (100) 硅上的 Si-Q 碳连续生长金刚石
- DOI:
10.1557/s43578-023-01264-7 - 发表时间:
2023 - 期刊:
- 影响因子:2.7
- 作者:
Nayna Khosla;Jagdish Narayan;Roger Narayan - 通讯作者:
Roger Narayan
Correction to: Mechanical Reliability and In Vitro Bioactivity of 3D-Printed Porous Polylactic Acid-Hydroxyapatite Scaffold
- DOI:
10.1007/s11665-021-05719-y - 发表时间:
2021-04-13 - 期刊:
- 影响因子:2.000
- 作者:
Chander Prakash;Gurminder Singh;Sunpreet Singh;Linda Yongling Wu;H. Y. Zheng;Seeram Ramakrishna;Roger Narayan - 通讯作者:
Roger Narayan
Molecular imprinted polymer based microneedle-strip electrochemical sensor for label-free dopamine monitoring: Advancing neurological disorder Diagnostics
基于分子印迹聚合物的微针条电化学传感器用于无标记多巴胺监测:推进神经障碍诊断
- DOI:
10.1016/j.cej.2025.163870 - 发表时间:
2025-07-15 - 期刊:
- 影响因子:13.200
- 作者:
Lakshmi R. Panicker;Anjalin Joy;P.R. Anusree;Sachin Kadian;Roger Narayan;A. Padmesh;Yugender Goud Kotagiri - 通讯作者:
Yugender Goud Kotagiri
Roger Narayan的其他文献
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{{ truncateString('Roger Narayan', 18)}}的其他基金
IRES Track I: US-South Korea Collaborative Training Program on Advances in Medical 3D Printing
IRES Track I:美韩医疗 3D 打印进展合作培训项目
- 批准号:
2106331 - 财政年份:2021
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
EAGER: Light Integrated novel multimodal microscale transdermal drug delivery biosystem
EAGER:光集成新型多模式微尺度透皮给药生物系统
- 批准号:
2029974 - 财政年份:2020
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
NSF/FDA Scholar in Residence Program on Physico-Chemical Characterization and In Vitro Biological Evaluation of 3D Printed Ceramics
NSF/FDA 3D 打印陶瓷物理化学表征和体外生物学评估常驻学者项目
- 批准号:
2037636 - 财政年份:2020
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
GOALI: Laser-based Layer-by-Layer Nanomanufacturing of Water Insoluble Drug-Loaded Thin Films
GOALI:基于激光的逐层纳米制造水不溶性载药薄膜
- 批准号:
1762202 - 财政年份:2018
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
ICorps: Innovative Printing Approach for Transdermal Drug Delivery
ICorps:透皮给药的创新印刷方法
- 批准号:
1612937 - 财政年份:2016
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
EAGER: Minimally invasive biosensors for detecting flavivirus infection
EAGER:用于检测黄病毒感染的微创生物传感器
- 批准号:
1651359 - 财政年份:2016
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
CNIC: US-Australia Planning Visits for UNC-NCSU-Queensland Partnership on Novel Materials and Devices for Transdermal Sensors
CNIC:美国-澳大利亚计划访问北卡罗来纳大学-北卡罗来纳州立大学-昆士兰大学关于透皮传感器新型材料和设备的合作伙伴关系
- 批准号:
1401950 - 财政年份:2014
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
GOALI: Collaboration on Novel Materials and Methods for 3D Printing of Microscale Medical Devices
GOALI:微型医疗器械 3D 打印新材料和方法的合作
- 批准号:
1437461 - 财政年份:2014
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
NSF/FDA Scholar in Residence Program on In Vitro Biological Characterization of 3D Printed Small-Scale Medical Devices
NSF/FDA 3D 打印小型医疗器械体外生物学表征常驻学者项目
- 批准号:
1445727 - 财政年份:2014
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
NSF/FDA Scholar in Residence Program on Characterization of Micro- and Nanostructured Titanium Oxide and Zirconium Oxide Surfaces for Improved Medical Implants
NSF/FDA 常驻学者项目,研究用于改进医疗植入物的微米和纳米结构氧化钛和氧化锆表面的表征
- 批准号:
1343533 - 财政年份:2013
- 资助金额:
$ 10万 - 项目类别:
Standard Grant
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