Confluent公司推出头颅手术的密封系统

一种新型系统设计用于在头颅手术中辅助进行双重修补获得防水闭合。该套系统已经获得美国食品药品管理局的许可，进行批准后的临床试验。

DuraSeal是获得保护的、合成的、可吸收的水凝胶，通过双重注射涂药器给药。这套设备储存于室温之下，能够在2分钟内完成准备工作。当喷射到硬脑膜之上的时候，可以产生强大的黏附密封层，能够在几秒钟之内有效地封闭缝合口。其独特的特征是其蓝色着色剂，能够让外科医生方便地观察硬脑膜上面的涂层以及厚度。

在手术之后，密封层能够持续密封胶下面的缝合线。在数周之后，水凝胶分解成为水溶性分子，被肾脏吸收清除出体外。临床试验显示：密封系统能够在98％的患者之中产生防水密封效果，在95％患者之中第一次应用即可获得密封效果。使用这种产品的神经外科医生将95％的应用过程评价为“容易～非常容易。”

这项多中心临床试验的首席研究员、南佛罗里达大学神经外科主席Harry van Loveren指出：“迄今为止，硬脑膜的防水闭合一直是很难达到的目标。我很有信心这种产品能够对我的头颅手术产生深刻影响。”

DuraSeal是Confluent外科手术公司的产品，该公司是一家私人医疗设备公司，致力于安全的使用简便的原位聚合生物物质的研发，允许在疾病部位形成定制移植物。

Sealant System for Cranial Surgery
 
A new system is designed as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure. The system has been cleared by the U.S. Food and Drug Administration (FDA) with a condition to conduct a post-approval study.

DuraSeal is a patented, synthetic, absorbable hydrogel that is delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes.

When sprayed onto the dura, it produces a strong adherent sealing layer that effectively seals the suture line within seconds. A unique feature is the blue colorant that gives the surgeon excellent visualization of coverage and thickness of the material upon application to the dura.

Postoperatively, the sealant continues to seal the suture line as healing progresses under the gel. After several weeks, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys. Clinical studies show that the sealant can achieve watertight closure in 98% of cases, with immediate sealing obtained on the first application in 95% of cases. Neurosurgeons using the product rated 95% of applications as “easy” to “very easy.”

“Watertight closure of the dura has to date been an elusive goal,” noted Harry van Loveren, M.D., chairman of the department of neurosurgery, University of South Florida (St. Petersburg, USA) and principal investigator in a multi-center study. “I’m confident it will have a profound effect on my cranial procedures.”

DuraSeal is the product of Confluent Surgical (Waltham, MA, USA), a private medical device company pioneering the development of in-situ polymerized biomaterials that are safe, simple to use, and allow the formation of customized implants at the disease site.