AOT obtains CE certification for ‘world’s first human-approved contact-free laser cutting of bones with a robot’

AOT获得CE认证,用于世界上首个人类认可的机器人无接触式激光骨骼切割

2021-01-23 20:11:02 Roboticstrends

本文共1142个字,阅读需3分钟

Swiss medical technology company AOT has obtained CE certification for what it says is the “world’s first human-approved contact-free laser cutting of bones with a robot”. The patented Cold Ablation Robot-guided Laser Osteotome system – CARLO for short – is said to cut bones precisely and contact-free with a specialized laser using a robot. The laser beam vaporizes the water inside the bone substrate within milliseconds, so the bone will be removed precisely in layers, leaving no residue, as deep as desired or until it is severed. New cutting forms enable previously unachievable functional geometries for patient-specific, precisely fitting requirements. The laserhead mounted on a tactile robotic arm is controlled by a navigation system. Safety for patients and staff is the highest priority for CARLO. Every movement of the patient or change of the operation set-up lead to immediate termination and the laser head refocusses itself automatically till the correct position is reached again. This ensures automatic readjustment of any changes from a safe distance without patient contact. No tools need to be removed from the operating area; no drill or saw blade can bend, break-off and harm the patient. The pre-operative plan of the bone incision, already electronically created today, is passed on to the robot for autonomous execution without media discontinuity. An important step towards a continuous digitization process in surgical interventions. Assistant Professor Gabriele Millesi, president of the International Association of Oral and Maxillofacial Surgery (IAOMS), says: “As a team of maxillofacial surgery at the Medical University of Vienna, it was very important and an honor for us to participate in an impressive chapter of innovative intraoperative surgical technology. “We were able to use the CARLO technology with success and conviction on patients with skeletal dysgnathias (malposition of jaw) of various degrees of severity, with very satisfactory results for us as surgeons as well as for our patients. “The future of the CARLO will be determined in the high precision and the individually designable cutting trajectories. The successful first-in-man study is a door-opener.” Cyrill Bätscher, CEO of AOT, says: “The CE certification after years of intensive development is an important milestone. We have demonstrated the enormous potential of contact-free, robot-assisted surgery based on our laser technology for cutting bones. “We have thus come a huge step closer to our vision of elevating classic surgical tools to the next level with our latest technology for the benefit of patients.” Dr Erich Platzer, chairman of the board and business angel investor since the beginning, says: “AOT still has big plans. “CARLO is now CE-certified for applications in CMF surgery – our focus is now on medical indications with a larger number of cases, such as neuro and spine surgery. We also rely on the use of artificial intelligence to analyse tissue and identify tumorous tissue in real time to be able to remove it with our CARLO.” “Let’s go West, CARLO”, says Dr. Bernhard Schirmers, biggest institutional investor of AOT and founding partner of SHS Gesellschaft für Beteiligungsmanagement, indicating the company’s efforts to obtain FDA approval for its technology in the US market. For CE certification, CARLO was used for the first time in a clinical study in the context of operations for jaw correction, which has proven the efficiency and safety of the technology in a clinical environment. The University Hospital Basel, the Medical University of Vienna (AKH Wien) and the University Medical Centre Hamburg-Eppendorf took part in the study.
瑞士医疗技术公司AOT日前获得CE认证,该公司称这是世界上首个人类认可的机器人无接触式激光骨骼切割技术。 专利的冷消融机器人引导激光骨刀系统CARLO,简称,据说切割骨骼精确和无接触与一个专门的激光使用机器人。 激光束在毫秒内汽化骨基质内部的水,因此骨将被精确地分层去除,不留任何残留物,深到想要的程度或直到它被切断。 新的切割形式使以前无法实现的功能几何形状,以满足病人的特定,精确的要求。安装在触觉机械臂上的激光头由导航系统控制。 病人和工作人员的安全是卡洛最优先考虑的问题。病人的每一个动作或手术设置的改变都导致立即终止,激光头自动重新聚焦,直到再次到达正确的位置。 这确保了从安全距离自动重新调整任何变化,而无需患者接触。不需要从操作区域移走任何工具;任何钻头或锯片都不能弯曲,断裂和伤害病人。 骨切口的术前计划,今天已经电子创建,被传递给机器人自主执行,没有媒体间断。外科干预中迈向连续数字化进程的重要一步。 国际口腔颌面外科协会(IAOMS)主席,助理教授Gabriele Millesi说:作为维也纳医科大学颌面外科的一个团队,能够参与创新术中外科技术的一个令人印象深刻的篇章对我们来说是非常重要和荣幸的。 我们能够成功地将CARLO技术应用于不同严重程度的骨骼性下颌失调(下颌错位)患者,取得了非常满意的结果,我们作为外科医生以及我们的患者都是如此。 高精度和可单独设计的切削轨迹将决定着CALLO的未来。成功的第一个人研究是一个打开大门的机会。 AOT首席执行官Cyrill Btscher表示:经过多年的深入发展,CE认证是一个重要的里程碑。我们已经展示了基于激光切割骨骼技术的无接触,机器人辅助手术的巨大潜力。 因此,我们向我们的愿景迈进了一大步,即用我们的最新技术将经典手术工具提升到下一个水平,造福于患者。 从一开始就担任公司董事长和商业天使投资人的埃里希•普拉泽博士表示:AOT仍有重大计划。 Carlo现已获得CMF手术应用的CE-认证,我们现在的重点是更多病例的医学指征,如神经和脊柱手术。我们还依靠人工智能来分析组织并实时识别肿瘤组织,从而能够用我们的Carlos将其移除。 我们走吧,卡罗,AOT最大的机构投资者,SHS Gesellschaft fr Beteiligungsmanagement的创始合伙人Bernhard Schirmers博士说,表示该公司正在努力争取FDA批准其技术进入美国市场。 为了获得CE认证,CARLO首次在临床研究中被用于颌骨矫正手术,这证明了该技术在临床环境中的有效性和安全性。 巴塞尔大学医院,维也纳医科大学(AKH Wien)和Hamburg-Eppendorf大学医疗中心参加了这项研究。

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文