• 3D Systems 承诺给予支持

    新型冠状病毒肺炎的迅速扩散给许多医疗保健供应商为受影响患者提供治疗和护理带来了巨大压力。3D Systems 目前正在提供服务,同时希望我们的客户和合作伙伴加入进来,共享资源,帮助战胜这场流行病。人们在这种具有迫切需求的时候所表现出的互帮互助,让我们看到了他们最无私奉献的一面。

    如果您的工程团队能够投入时间和专业知识,或提供 3D 打印机使用机会,对于您的支持,我们将非常感激。相反,如果您是需要缩小供应链差距帮助的医疗器械制造商、医院或医疗保健提供商,请告诉我们您的需求。我们会竭尽所能满足您的请求。

  • 给予医疗器械制造商的支持

    我们承诺通过塑料或金属材料的 3D 打印组件为医疗器械制造商提供支持,帮助他们缓解重症监护设备的供应链压力,如呼吸机和经认证的口罩。3D Systems 的服务能力卓越,能够提供多样化的服务,包括 GMP 制造设施和经验证的打印流程。了解更多。

  • 为定点机构/医院提供支持

    我们将针对定点机构的未满足需求和紧急需求提供解决方案。例如,个人防护用品的制造和打印支持、呼吸机文丘里阀的制造能力以及肺部超声程序的医疗培训资源。了解更多。

  • 意大利技术、创新和数字化部长

    Venturi Ventilator Valves - Photo Credit - Christian Fracassi and team - Isinnova and Lonati SpA - Printed in Italy on a ProX 6100 in Medical Grade Nylon

正在探索的解决方案

下表显示了当前正在探索的应用的摘要视图

分类 零件 当前活动 状态 临床应用 后续步骤
PPE - 高功率防护面罩 高功率框架,无护目镜 制造 已上市 已上市
PPE – 防护面罩,带护目镜 带护目镜框架 优化的 SLS 尼龙材料 启动 验证
PPE – 口罩 临时口罩 制造 已上市 已上市
  外科口罩1 认可 启动 制造
  外科 N95 口罩1 原型制造 启动 基准测试
呼吸机解决方案 各种 为呼吸机原始设备制造商提供支持 启动 继续开展合作
  分离器 HCP 评估 已上市 联系参加临床验证
诊断 棉签 HCP 评估 已上市 联系参加临床验证
医疗教育 Lung Ultrasound COVID-19 Training Module 可用 启动 是,用于临床培训 联系参加临床验证
材料 所有 Material Technology Overview Chart2 created for download for Printer-material section 视图   以下概览内容可能根据不断得出的结果而有所更改。表格会定期更新以反映相应更改。

1 查看 FDA 指南和定义

2 3D Systems Material Technology Overview Chart
We have prepared a Material Technology Overview Chart to identify the best candidates for printer-material combinations for which either Class VI and/or ISO 10993 certifications are possible for COVID-19 applications, including potential solutions to the COVID-19 applications in emergency situations though the materials are not Class VI and/or ISO 10993 certified and customers should conduct their own testing to determine whether certification is possible. 

  • 大批量生产鼻咽拭子采集棒

    • Mass-Produced Nasal Swabs FLEX-CLR 20

      Single row of 20 swabs linked together for ease of cleaning and removal. 240 swabs were printed in 5 hours 10 minutes with our FLEX-CLR 20 material. Material available upon request.

    • 正在 Figure 4 上采用 3D 打印技术批量生产鼻咽拭子采集棒

      Figure 4 正在打印鼻咽拭子采集棒。

  • 需求

    There is a shortage of nasopharyngeal (NP) swabs to test COVID-19 patients as large-scale testing ramps up. Most test kits are limited to those who show severe symptoms. As such, it’s hard to determine who is asymptomatic in order to curb community spread through other methods than shelter-in-place policies.

    解决方案

    我们正在与临床医生合作,测试我们的系统打印的鼻咽拭子采集棒所用的材料和打印流程。我们相信,Figure 4 及其可高压灭菌的生物相容性材料非常适合在短时间内批量生产大量鼻咽拭子采集棒。

    结果

    Through clinical testing and validation, we have established a custom NP swab design and a medical-grade, clear material for this application that will meet clinical standards. Our medical grade material, FLEX-CLR 20, is a flexible, bio-compatible and autoclavable material that is chemically safe, can produce parts that bend at least 180 degrees without breaking and gather viral material for testing. This material is available upon request, contact us for more information. Based on our capacity analysis of a single Figure 4 system running FLEX-CLR 20, we can print 240 swabs in 5 hours and 10 minutes or 84 seconds per swab. We also have several ISO 13485 certified facilities that can produce medical parts.


  • 口罩应用

    • 3D Systems 临时口罩

      以 Duraform ProX PA 材料在 SLS ProX 500 设备上制造的临时防护面罩

    • 3D Systems 临时口罩图

      临时防护面罩示意图

  • 需求

    作为个人防护用品的口罩的短缺正在将一线工作人员和二级支持性服务医疗保健专业人员置于危险境地。在美国,医用口罩受美国食品药品安全监督管理局 (FDA) 监管(见指南)。当无法获得 FDA 认可的口罩或防毒面具时,医疗保健专业人员可以选择临时个人防护用品。在不受 FDA 监管的司法管辖区可能会发生类似情况。

    解决方案

    3D Systems 与 Veterans Health Administration 的工程师和临床医生合作开发了一款紧急的临时口罩 (SFM)。这款口罩有多种尺寸,采用选择性激光烧结技术以生物相容性尼龙材料打印而成。它由 3d 打印的口罩和过滤罩、两个弹性带以及矩形的过滤材料贴片组成,可使用消毒剂和/或通过高压灭菌再次进行处理。

    结果

    这款临时口罩可在无法取得标准个人防护用品时用作医用,或用于不需要合规个人防护用品的非关键非医用环境。这款临时口罩的设计已在临床环境中经过审查,在依据 FDA 指南规定进行制造的前提下推荐使用,具体应参照说明书 (IFU) 的说明。下载内容中包括 3d 打印文件、IFU 以及用于采用 3D Systems 的选择性激光烧结技术打印机和 Duraform PA 或 Duraform ProX PA 材料进行打印的制造指导文件。选择性激光烧结技术可用于批量制造此口罩和过滤罩。

    在此,3D Systems 谨向此项目中的所有合作方致谢。可在 NIH 3D 打印平台 上了解更多信息。


  • 可重复使用的防护面罩框架

    • 用于提高防护能力的防护面罩和帽子。

      以医用级 Nylon 12 (Duraform PA) 为材料在选择性激光烧结技术打印机上打印的两件式防护面罩框架。

    • 3D Systems 防护面罩设计的渲染图

      Diagram showcasing the two sections of the SLS face shield frame assembled together.

    • A face shield mask 3D printed using SLA technology

      A face shield frame printed on a Stereolithography printer with Accura ABS White (SL 7810).

  • 需求

    There is a shortage of Face Shields at hospitals for medical responders who are testing and treating COVID-19 patients. Medical responders need to be protected from respiratory droplets from coughing and sneezing. Even though many individuals and groups are designing and manufacturing face shield frames for these responders, many of the designs are not optimized for high-density optimized additive manufacturing and cannot be accessed locally.

    解决方案

    我们已经设计出了一种防护面罩框架,此框架:

    • A downloadable file to enable local production using any Selective Laser Sintering (SLS)  or Stereolithography (SLA) printer
    • 针对高密度嵌套进行了优化
    • 采用医用级尼龙和可重复使用设计,可高压灭菌并与消毒清洁剂兼容
    • 采用灵活的非刚性贴合设计,非常舒适
    • 可搭配面罩和手术帽,使用固定扣固定可保护前额和眼睛

    结果

    我们已经在 SLS ProX 6100 打印机上使用医用级尼龙制造出了这款防护面罩框架。此框架采用由两部分组成的扁平设计,可相互夹在一起组成一个结构,在最大程度减少材料用量的同时最大化了可在 SLS 打印机上制造的部件的密度。框架的两部分可以拆开进行清洗。

    The SLA face shield design was optimized and manufactured using medical grade Accura ABS White (SL 7810) on our SLA ProX 500 machine. It was designed for flexibility, robustness, comfort, field of view and efficiency while printing. 216 frames were printed in about 70 hours, the frames were cleaned and post-processed in two days.


  • Ventilator Splitters

    • Ventilator Splitter parts printed in MED-AMB/SG

      2 splitters can be printed in 90 minutes on the Figure 4 with MED-AMB/SG material.

  • 需求

    A ventilator splitter is a device that allows a single ventilator to support two or more patients during this crisis. Approximately 2.4% of all COVID-19 patients in this pandemic will require mechanical ventilation.

    解决方案

    The ventilator sharing concept was first written by Dr. Neyman and Dr. Irvin in 2006 (Ac Emergency Medicine 2006). By using T-tubes and adapters, a circuit could be divided so four patients can share a single ventilator in an emergency. One group, Ventsplitter.org has released an open-source file for emergency POC uses along with flow limiters when pairing different patients (body weight, lung compliance, etc). 

    结果

    Additive manufacturing presents the opportunity to rapidly produce splitters for hospitals. We have several sterilizable and biocompatible materials available on all of our systems that can be used to print these parts along with several ISO 13485 certified facilities that can produce medical parts.

资源

Case Studies

  • 呼吸机文丘里阀

    呼吸机文丘里阀

    挑战

    对于新型冠状病毒肺炎重症病例,患者需要通过使用呼吸机进行重症监护和吸氧。随着全球重症病例不断增多,医院里的呼吸机文丘里阀出现供应短缺。

    解决方案

    1. 虽然有 SLS ProX 6100 在意大利打印的文丘里阀作为最后一刻的解决方案,但仍需开展更多测试来验证更新的开源设计。

    2. 我们正在寻找可用于此应用情形的具有生物相容性且不发生反应的替代材料和技术。

    结果

    意大利基亚里 (Chiari) 的一家医院的临床病例使用了 3D 打印的文丘里阀。传统原始设备制造商无法在如此短的时间里供应这些阀门。在 3 天时间里,使用 SLS ProX 6100 对部件逆向工程、原型制造、测试并使用医用级尼龙材料打印出了部件。

  • Simbionix

    肺部超声检查

    挑战

    肺部超声被视为新型冠状病毒肺炎患者的胸部 X 光或 CT 扫描检查的一种替代检查方法。此方法安全简易,且可在定点机构快速使用,同时具有可重复、成本低、无辐射的特点。因此,对内科医生进行培训,使他们迅速掌握肺部超声检查技巧对于成功控制新型冠状病毒肺炎至关重要。

    解决方案

    Simbionix 模拟可对这项检查进行全方位培训,同时包括在全临床环境中对各种肺部区域、记录和临床报告进行练习。

    结果

    我们的团队全天候工作,在 Simbionix U/S Mentor 模拟器上开发相关的新型冠状病毒肺炎学习和培训内容。如果您是具备相关经验的内科医生,我们鼓励您加入我们,参与这项开发工作。

  • a woman in scrubs working on a laptop showing medical software

    Bedside Cardiac ICU

    挑战

    The COVID-19 pandemic can make traditional cath lab activities difficult.  Transportation of patients to and from the lab provides an increased risk of spreading infection.  Cardiology Societies now recommend that these procedures be conducted beside instead of in a catheterization laboratory. 

    解决方案

    The Bedside Cardiac ICU module on the Simbionix ANGIO Mentor is designed to provide practice for interventions that are being performed at the bedside of suspected/confirmed COVID-19 patient with no fluoroscopic guidance.

    结果

    As a result of 3D Systems’ quick and realistic development of the Bedside Cardiac ICU module, institutions are able to provide hands-on training of these very timely skills, and thus limit exposure of COVID-19.

3D Systems Community如何提供帮助


  • 常见问题解答

    是否有可能 3D 打印 N95 口罩或防毒面罩?

    3D 打印生产的 N95 口罩需要经过鉴定并符合 N95 标准。

    是否有可能 3D 打印防护面罩框架?

    • 可以 — 我们正在研究几种可使用多种我们的技术进行打印的 3D 打印防护面罩框架设计。
    • SLS 打印机,如适用 DuraForm PA (SLS)DuraForm EX Natural (SLS) 材料的 ProX SLS 6100-3D 打印机,是快速生产当前设计的防护面罩的理想打印机之选。
    • 我们目前正在与按需制造服务部合作,开始就防护面罩制造加强沟通力度,帮助将防护面罩带到地区医院。

    是否有可能 3D 打印鼻咽拭子测试套件?

    我们目前正在对各种材料和设计进行测试,以弄清楚它们是否符合有关鼻咽拭子的 CDC 标准。

    Is 3D Systems printing parts for COVID-19?

    我们目前正在根据原始设备制造商和其他经认证医疗器械制造商的要求制造部件。

    Are 3D Systems OEM customers printing parts for COVID-19?

    Yes, 3D Systems OEM customers are printing parts for COVID-19. We are partners with service bureaus and OEM customers that utilize our technology to print parts.
     

    3D Systems 是否有医疗培训解决方案?

    Simbionix 已经开发了一个肺部超声模拟模块,此模块有助于培训用户进行肺部检查。了解更多

    As institutions change to distance learning programs during the coronavirus, 3D Systems is offering educators and learners an abundance of resources via our MentorLearn Cloud platform.  These videos, curricula and other online materials are available free-of-charge for three months during the COVID-19 pandemic.  Remote learning tools span a wide range of medical specialties, tasks and procedures.

    通过向 [email protected] 发送电子邮件,注册并请求在线学习访问权限。

    Simbionix is also posting clinical recommendations from professional organizations to their website. View COVID-19 clinical recommendations

    3D Systems 是否具有医用级材料?

    Yes, we have a broad range of material across many technologies that can meet medical-grade specifications and biocompatibility. A 3D Systems Material Technology Overview Chart is available to identify the best candidates for printer-material combinations for which either Class VI and/or ISO 10993 certifications are possible for COVID-19 applications, including potential solutions to the COVID-19 applications in emergency situations though the materials are not Class VI and/or ISO 10993 certified and customers should conduct their own testing to determine whether certification is possible.
     

    3D Systems 公司位于何处?

    我们的设施遍布全球,包括美国、欧洲、亚洲、南美洲和澳大利亚。

  • COVID-19 Support Webform

    如果您有任何问题或能够为您的工程团队投入时间和专业知识,或提供 3D 打印机使用机会,我们将非常感激您提供的支持

    寻求支持

    您最需要哪种类型的支持?

    提供支持

    您和/或您的组织能够向他人提供哪些服务?
    问题 0 1 到 3 4 以上
    您曾经是否制造过呼吸机部件或系统?
    在临床上是人用还是兽用?
    您曾经是否制造过医疗器械或部件?

免责声明

生产医疗部件需要符合某些法规。上述部件和设计目前不具有监管机构的许可。对于任何必要的验证和监管批准,3D Systems 概不负责。

3D Systems 参考或提供的任何设计文件均是“按原样”提供,且不带有任何形式的担保或保证,包括但不限于对特定用途的适用性、适销性或不侵权的担保。用于制造医用部件的设计文件不包含任何注册或认证。此类设计文件的使用者对他们自身对设计文件和任何适用的监管批准(或其例外规定)的使用,以及任何责任求偿(包括但不限于产品责任或知识产权侵权)承担全部责任,并使 3D Systems 免于承担可能由设计文件的使用引起的任何责任。