医疗和牙科

Bellaseno实现ISO 13485认证和420万欧元的3D印刷乳房植入物

贝拉塞诺是一家德国医疗创业公司,已获得ISO 13485认证,其3D印刷乳房植入物(以Senealla为品牌)获得了认证。该公司还宣布,已从现有投资者那里筹集了100万欧元,总计420万欧元的资金。

根据Bellaseno首席执行官Simon Champ的说法,资金和认证将使Senella进行临床试验。Champ补充说:“我们将根据ISO 13485认证为全球其他MedTech公司提供整个过程,从概念和内部设计到原型制造,临床试验和系列生产。”

3D打印的乳房植入物。通过Bellaseno的照片。
一个Senella3D printed breast implant. Photo via BellaSeno.

Senella technology

自2015年成立以来,Bellaseno一直致力于开发一种替代硅乳房植入物的替代方法,该植入物将异物永久引入患者。因此,引入了Senella技术,并产生可以通过人体吸收的多孔多孔多丙酮酸(PCL)支架。

一个ugmentation of the breast is achieved as fat tissue is harvested via liposuction and injected via lipofilling into the scaffold. This provides a stable platform for the tissue to mature over a two-year span, resulting in natural breast free of foreign materials and any complications concerning silicone implants.

贝拉塞诺(Bellaseno)认为,塞内拉(Senella)会破坏乳房重建和增强技术。预计乳房植入物的首次临床试验将于2019年第四季度开始。

将脂肪填充过程插入乳房和塞内拉植入物中的例证。图片通过Bellaseno。
将脂肪填充过程插入乳房和塞内拉植入物中的例证。图片通过Bellaseno。

一个dditive manufacturing and breast reconstruction

Elsewhere, additive manufacturing has been used in breast reconstruction and augmentation. Last year, plastic surgeons at拉德布德大学in the Netherlands discussed the applications and limitations of usingpatient-specific 3D prints作为intraoperative guides

This research focuses on autologous “flap” reconstruction, where tissue from one part of the body, such as the abdomen or thigh, is used as material to rebuild another body part. This is a common practice for all types of breast correction surgeries, in cases of asymmetry and augmentation, or following tumor removal.

FDA研究人员也发展了patient-specific 3D printed breast phantoms它们被用作乳房X线摄影装置的测试床,以确保优化的乳腺癌检测和治疗。

Standard types of breast phantoms used in mammography research. Photo via Kyoto Kagaku.
Standard types of breast phantoms used in mammography research. Photo via Kyoto Kagaku.

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特色图像显示了3D印刷的乳房植入物。通过Bellaseno的照片。