A 3D printed biomimetic graft developed by a multidisciplinary team at Harvard University’sWyss Instituteled by Gliklich Healthcare Innovation Postdoctoral Research Fellow Nicole Black is seeking 510K clearance from the USFood and Drug Administration(FDA).
Named thePhonoGraft该设备旨在模仿人体的耳膜，可用于遭受耳部创伤的患者，使耳膜能够通过产生新细胞来治愈自己。
希望3D打印的设备能够提高外科手术程序的速度和成功，同时降低患者的手术成本。
Developing the PhonoGraft
由于创伤，慢性耳部感染和皮肤异常生长的导致耳膜的穿孔会导致严重的听力损失和反复感染，并且根据WYSS研究所的调查，全球约有3000万人发生。
When these perforations do not heal on their own, they require reconstructive “tympanoplasty” surgery to repair the defects using graft materials taken from other parts of the body, such as the fascia. However, these grafts do not always ensure full mending of the eardrum, meaning that patients often require revision surgeries and could suffer long-term hearing loss.
In response to the need for a better and longer-lasting eardrum reconstruction method, Black began developing the PhonoGraft six years ago, working with Dr. Aaron Remenschneider at the马萨诸塞州的眼睛和耳朵医院in Boston, and Professor Jennifer Lewis atHarvard University.
The PhonoGraft is a biomimetic graft 3D printed from biodegradable elastomers that functions like a native eardrum, and due to the use of 3D printing can accommodate different ear sizes and requirements. Once inserted into the patient’s ear, the Phonograft effectively conducts sound and promotes native tissue and vascular cell growth while slowly biodegrading. As a result, new eardrum tissue is regenerated inside the ear that is capable of conducting sound and providing normal barrier functions against pathogens.
“PhonoGraft promotes tympanic membrane regeneration by combining biodegradability with its biomimetic architecture composed of circular and radial features,” said Black. “This graft conducts sound well at both low and high frequencies, thus restoring function far better than autologous tissue grafts, which are currently used.
“此外，我们预计语音移植将改善患者的康复和听力结果，从而减少对修订手术的需求。”
The road to FDA approval
布莱克和她的团队以前曾使用具有耳膜大小的龙猫模型在临床前研究中验证了语音移植，并且听力范围与人类类似。他们观察到语音移植有助于慢性穿孔的动物中天然组织的重塑，同时缓慢降解，并进行了听觉测试，这些测试确定了3D印刷设备比传统使用的自动组织移植物“更有效地”恢复了听力。
Now, Black is seeking 510K FDA clearance for the PhonoGraft, which she告诉迪特里奥特自由出版社could potentially enable doctors to carry out “dozens of eardrum repairs throughout the day”. She is also reportedly working on designs that could allow the Phonograft to be placed in the ear canal of patients while they are awake, requiring only local anesthetic as opposed to undergoing more time-consuming and expensive general anesthesia.
前锋,一旦收到FDA批准Black hopes the PhonoGraft will be marketable to ear, nose, and throat surgeons by the end of next year, or early 2023.
3D再生医学印刷
近年来，3D印刷的生物结构用于再生医学和组织工程的关注越来越多，其中new bioinks being continually developedthat are cable of supportinglong-term cell growth and survival.
In the past year alone, 3D printing has played a part in developing biocompatible constructs thatmimic human-sized airwaysable to support new cell and blood vessel growth, and in rapidly speeding up the process of fabricating cell-laden hydrogel structures that could one day lead to3D printed human tissue transplants.
Elsewhere, the technology has enabled thesimultaneous printing of skin and bone tissue修复伤害，还使科学家更近一步从根中再生牙齿.
除了研究突破外，3D打印机OEM之类的3D Systemsand 3D bioprinter manufacturerCELLINK在再生医学领域也取得了长足的进步。宣布计划scale up its bioprinting activities鉴于今年早些时候印刷到灌注平台的进展，3D Systems最近公布了与再生医学公司的共同开发协议CollPlantto develop3D bioprinted soft tissue structures用于乳房重建治疗。
CELLINK, meanwhile, acquired in-vitro technology specialistMatTek Corporationin March to advance its research intoanimal cruelty-free cellular testing models, and a couple of months later acquired Two-Photon Polymerization (2PP) 3D printer manufacturerNanoscribewith plans to use the firm’s technology tofabricate more lifelike soft tissues.
来自3D系统和Cellink的代表参加了3D印刷行业最近的网络研讨会再生医学和3D印刷：机遇，挑战和未来方向, which is now available to watch on ourYouTube频道.
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Featured image showsthe 3D printed PhonoGraft biomimetic graft. Photo via Wyss Institute.
