Dural Sealant Provides Watertight Closure During Brain Surgery

A new device prevents cerebrospinal fluid (CSF) leaks and other complications by surgically sealing tissue during cranial procedures.

The Adherus AutoSpray Dural Sealant is a sterile, single-use, battery operated syringe applicator with internal system components that provides air flow to aid in the delivery Adherus dural sealant, and is meant to compliment standard methods of repair, such as the use of sutures. The device is supplied pre-assembled with two glass vials, one containing a polyethylene glycol (PEG) ester solution, and the other a polyethylenimine solution. Once the contents of the vials are mixed and applied through a spray nozzle, polymerization occurs within approximately one second.

During polymerization, a cross-linking reaction forms a physical interpenetrating network between the surgical sealant and the tissue surface, producing a robust hydrogel film that continues to adhere tenaciously to underlying tissue, providing a smooth, lubricous, compliant coating which prevents CSF leaks and prevents adhesions to bone and other tissue structures. The hydrogel is absorbed as the underlying dura tissue heals, breaking down over the course of approximately 90 days.

The degradation byproducts (mainly PEG) are water-soluble and therefore are resorbed and cleared through the renal and hepatic pathways; the molecular structure and neutral pH of the hydrogel's extracts make the surgical sealant inert and well tolerated by the body, and no toxic byproducts are created. The Adherus AutoSpray Dural Sealant is a product of HyperBranch Medical Technology (Durham, NC, USA), and has been approved by the US Food and Drug Administration (FDA).

The AutoSpray applicator was designed to simplify the preparation of the Adherus dural sealant formulation, which can now be accomplished in less than 90 seconds. It also enhances delivery of the formulation by facilitating controlled delivery and precise sealant placement, and allows delivery to be interrupted without the applicator clogging. Its use is contraindicated in anatomical spaces where nerve compression is a concern, since the hydrogel sealant may swell after application.

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