医疗和牙科

加拿大卫生部已批准其第一个加拿大制造的3D印刷医疗植入物

Health Canada涉及国家卫生的政府部门已批准其第一个加拿大制造的3D印刷医疗植入物。

3D打印设备是可自定义的下颌(下颌)板,用于面部重建手术,主要针对口腔癌患者。它也可以与手术指南一起用于切割和钻孔操作。

Named the Specifit 3D mandibular plate, the implant was developed by the 3D Anatomical Construction Laboratory (LARA 3D) in Quebec City. LARA 3D is a part ofInvestissement Québec (CRIQ),为新企业提供产品开发服务的组织。植入物的创建也得到了大学医院库贝克 - 乌梅蒂蒂·拉瓦尔, orthopedic screw manufacturer碱数字, and metal powder firmAP&C(一个GE Additivecompany).

The LARA 3D laboratory was launched in late 2020 and was issued an ISO 13485 certification in April 2021, meaning it’s certified to produce new medical devices for end-use healthcare applications.

“We are extremely proud to announce Health Canada’s approval of the Specifit 3D mandibular plate,” said Dr Gaston Bernier D.M.D., Medical Chief of Dental Medicine & Oncology at CHU de Québec-Université Laval.

An example of a mandibular plate. Photo via Xilloc.
An example of a mandibular plate. Photo via Xilloc.

Oral cancer and mandibular reconstruction

For patients that have been diagnosed with oral cancer, the removal of a section of the lower jaw is sometimes a necessary procedure. In these cases, mandibular reconstruction surgery is often used to normalize the lower facial contour, regain architectural support, and improve the relationships between any affected teeth. The procedure can give patients greater functionality when it comes to both speaking and chewing, vastly improving their quality of life.

为了实现下颌重建手术,必须使用下颌板。该设备可与重建手术进行对齐和稳定,同时促进愈合和长期骨融合。

Bernier adds, “Not only will it improve patients’ quality of life; but thanks to optimized, guided, and personalized surgery; it will also enable the development of a 3D medical equipment center of expertise at Centre de recherche du CHU de Québec – Université Laval. We are convinced the approval of this technology marks only the start of innovation, research, and development in 3D medical printing at LARA 3D.”

指定3D下颌板

Health Canada issued the Specifit 3D mandibular plate approval in September 2021, enabling surgeons to use the implant, together with two surgical cutting and drilling guides, to treat patients.

According to the approval, the 3D Specifit mandibular plate must be 3D printed using biocompatible materials. Medical professionals will be able to produce the implant using titanium grade 23, leveraging either laser powder bed fusion (for the implant itself) or electron beam melting (for the two surgical cutting and drilling guides).

由于该设备被设计为可自定义,因此治疗将受益于特定于患者。植入物可以根据患者的解剖结构打印3D,这将有助于提高手术成功率,并减少手术和康复时间。

Lyne Dubois, VP of CRIQ, adds, “With LARA 3D, CRIQ fully embraces its leadership role in Additive Manufacturing in Québec. The Specifit line of 3D prostheses will meet the needs of the healthcare sector and provide improved quality of life for patients. It also demonstrates the wide range of possibilities 3D printing affords companies that must design complex, light, and durable parts. The expertise acquired by CRIQ is accessible to the entire 3D printing ecosystem in Québec.”

The Investissement Québec (CRIQ) headquarters. Photo via Investissement Québec.
The Investissement Québec (CRIQ) headquarters. Photo via Investissement Québec.

Just in September, Danish medical device manufacturerParticle3Dwas granted a Chinese patent for a novel bio-ink that enables the3D printing of fully-resorbable porous bone implants。Composed of ceramic suspended in a fatty acid matrix, the firm’s biomaterial enables the production of patient-specific grafts with ‘bone-like’ porosity.

Elsewhere, at theUniversity of Basel, researchers recently developed a novel3D打印的植入物用于治疗眼窝裂缝that carries a reduced risk of patient rejection. Constructed using aprusa i33D打印机和Peek细丝,由于其多孔功能,该团队的移植物能够克服其材料的生物渗透率,这些功能可以量身定制以增强细胞修复。

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特色图像显示了下颌板的示例。通过Xilloc的照片。