Medical & Dental

NVISION和分水岭推出了第一个3D印刷前颈板,并带有FDA间隙

医疗设备制造商NVISION生物医学技术Watershed Idea Foundry据报道是世界上第一个印刷钛前宫颈板的FDA许可。

该医疗装置被称为量子钛宫颈板系统,是一种小板,通常用于在手术后为脊柱提供稳定性。

By 3D printing their cervical plate, Nvision and Watershed have been able to leverage the design benefits of additive manufacturing, combining multiple smaller components into one monolithic part. According to the firms, this greatly reduces the risk of accidental device disassembly for a patient. When compared to a traditionally manufactured counterpart, the 3D printed Quantum Titanium Cervical Plate System also lends itself to lower manufacturing costs and faster lead times.

NVISION生物医学技术和Watershed Idea Foundry are sister companies operating underFountainhead投资合作伙伴. They’ve previously collaborated on other 3D printed medical products such as wedges and interference screws.

“这是令人难以置信的激动人心的实现new product enhancements made possible by Additive Manufacturing,” stated Nick Cordaro, CEO of Watershed Idea Foundry. “Nvision’s willingness to champion Additive Manufacturing innovation into a commercial product made for an ideal technology transfer scenario.”

量子钛宫颈板系统。通过NVISION生物医学技术图像。
量子钛宫颈板系统。通过NVISION生物医学技术图像。

What is an anterior cervical plate?

发达国家早在1980年代,颈椎前路人民解放军tes are applied to the front of the spine during surgery to protect bone grafts and provide integrity to the spinal construct while it heals. They were initially used in long cervical fusions but are increasingly seeing use for anterior cervical decompression, fusion for cervical spondylosis, degenerative disc disease, and scoliosis.

Conventionally manufactured cervical plates tend to be quite costly to produce and comprise several smaller components, meaning there’s a risk they could disassemble themselves if they aren’t fitted or screwed in correctly. The Quantum Titanium Cervical Plate System is designed to address this.

The Quantum Titanium Cervical Plate System

该设备最值得注意的创新是其整体性质,螺丝锁盖是3D印刷为单个结构的。由于没有涉及多个组件或关节,因此该板消除了拆卸服务的风险。

It also features two different surface finishes, whereby the posterior surface is textured and the anterior surface is polished. The textured surface lends itself to osteointegration (bone fusion) while also absorbing some of the load that would otherwise be on the screws. Additionally, some of the screw holes have been printed at angles of 30º, a design choice that allows the plate itself to be shorter while still ensuring a robust hold on the spine.

Tom Zink, Nvision’s Senior Vice President of Product Development, explains, “By Additive Manufacturing the Quantum system, we leveraged design options that were not available with machined plates. The active locking system is integrally printed within the plates, and therefore never assembled, which means the locks cannot become unassembled in the surgical field.”

Inside Watershed Idea Foundry's manufacturing facility. Photo via Watershed Idea Foundry.
在流域Idea Idea Foundry的制造工厂。通过流域创意铸造厂的照片。

医疗部门最重要的3D打印应用程序之一是可植入的医疗设备。刚刚,加拿大卫生部, the government arm that deals with national health, approved its第一个加拿大制造的3D印刷医疗植入物. The 3D printed device is a customizable mandibular (lower jaw) plate for use in facial reconstruction surgery, predominantly for patients with oral cancer. It can also be used in conjunction with surgical guides for cutting and drilling operations.

在其他地方,3D生物打印公司BICO最近宣布了一项与再生联合替代启动的150万美元的合同制造协议Nanochon. The deal will see Nanochon purchase products and services worth $1.5 million from BICO’s分数company to develop its3D打印的再生关节植入物,初创企业索赔将为患者提供更快的恢复速度,同时减少卫生提供者的成本。

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特色图像显示了量子钛颈板系统。通过NVISION生物医学技术图像。