医疗和牙科

3D系统通过两种新材料授予3D印刷手术指南的510(k)FDA清除率雷竞技官网登录

开创性3D打印机制造商3D Systemshas announced that it has received510(k) clearancefrom the FDA to 3D print使用其Laserform Ti和Durafor雷竞技官网登录m Prox PA材料的颌面外科手术指南。

According to the company, the new material choices will enable users to 3D print more innovative, lower profile surgical guide designs as part of itsVirtual Surgical Planning(VSP) service. This will serve to give its customers, surgeons, greater access and visibility to the surgical site, reducing both operating times and the risks involved with maxillofacial surgery.

手术标记指南用于精确指导钻孔和切割雷竞技官网登录操作。图像通过3D系统。
手术标记指南用于精确指导钻孔和切割雷竞技官网登录操作。图像通过3D系统。

The Virtual Surgical Planning service

3D Systems的VSP是一种基于服务的个性化手术方法,借鉴了公司在医学成像,外科模拟和增材制造方面的专业知识。雷电竞充值自2018年以来,它已与craniomaxillofacial product specialistStryker’s CMF division

Surgeons interested in the process present their desired surgical plans, along with any medical scans, in an online video meeting with a member of the 3D Systems biomedical engineering team. Together, they plan and simulate the surgical procedure to generate a ‘digital plan’. The VSP team can then 3D print patient-specific models, guides, and templates for the surgeon to take into the operating room. To date, the service has helped out in more than 120,000 patient cases around the globe.

Menno Ellis, Executive VP of Healthcare Solutions at 3D Systems, states: “Through close collaboration with surgeons and Stryker’s CMF division, we’ve uncovered opportunities to refine VSP guide designs that leverage additional capabilities in our materials portfolio. Our expert biomedical engineers are now able to design surgical guides tailored to the surgeon’s needs with enhanced properties that can help improve accuracy and facilitate procedures in ways not previously possible. Our powerful VSP System continues to transform surgery – enabling better patient outcomes.”

VSP服务用于数字计划,以提高成功率。图像通过3D系统。
VSP服务用于数字计划,以提高成功率。图像通过3D系统。

The LaserForm Ti and DuraForm ProX PA materials

新的材料选择将允许VSP服务以较少的整体体积打印外科手术指南,同时提高其优势和僵化。雷竞技官网登录根据该公司的说法,机械测试以前表明,在Laserform Ti中打印的切割和标记指南3D可以比其常规制造的钛对应物强20倍。雷竞技官网登录强度的增加意味着它们的稀释剂可能会稀释约70%,从而更容易进入关键手术部位。

在Durafor雷竞技官网登录m Prox PA中打印的标记指南3D还可以提供比标准尼龙高度高达88%的韧性,从而使它们能够在过程中承受更大的力。最重要的是,两种材料都已确认为广泛的灭菌方法安全。外科医生能够使用包裹或小袋雇用手动清洁,自动清洁和蒸蒸,以确保在进入手术室之前,设备已经准备就绪。

LaserForm Ti is a medical-grade titanium powder for use with powder bed fusion sytems. Photo via 3D Systems.
LaserForm Ti is a medical-grade titanium powder for use with powder bed fusion sytems. Photo via 3D Systems.

随着技术能力的标准和进步的发展,近年来,医疗设备的3D打印已加速。就在上个月ACSCustom, a specialist in customized hearing protection, announced that it was implementing 3D Systems’ Figure 4 system into its facility to upgrade its助听器的生产。该公司表示,它打算使用图4 Pro-Blk树脂生产其小规模的入耳式设备。

在其他地方,数字制造服务提供商Fast Radiushas previously partnered withAxial3D, a UK-based medical technology firm, to launch a‘DICOM-to-print’ servicefor surgeons and hospitals across North America. The project will give clinicians access to improved surgical planning with micro-millimeter accurate, patient-specific 3D printed anatomical models.

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Featured image shows 3D printed titanium surgical guide. Image via 3D Systems.