Validation of a Bioabsorbable Device that Seals Perforations After Tuohy Needle Dural Puncture in an Ovine Model

Abstract

(Reg Anesth Pain Med. 2021;46:389–396. doi: 10.1136/rapm-2020-102225. Epub January 27, 2021) Cerebrospinal fluid (CSF) leak can lead to postdural puncture headaches (PDPH) and other adverse outcomes following an accidental dural puncture (ADP). The current “gold standard” treatment is an epidural blood patch, optimally performed at least 48 hours following ADP. No current therapy has yet been shown to prevent the onset of PDPH when applied prophylactically, immediately following an ADP. To address this, the authors designed a bioabsorbable device, in the form of a physical patch, which is inserted via the Tuohy needle immediately following an ADP, to seal the dural hole preventing further CSF leakage. The device consists of a patch which unfolds inside the subarachnoid space. A thread passes from the device, through the dural hole, ligamentum flavum, interspinous and supraspinous ligaments and into the subcutaneous tissues. By means of unidirectional barbs along the thread, traction is provided to hold the patch against the dura. The device is contained inside a flexometallic cannula, which is advanced through the Tuohy needle via an applicator, and introduces the device into the subarachnoid space. After placement, the flexometallic cannula, applicator, and epidural needle are removed in order, leaving only the patch and barbed thread in situ. The aim of this study was to determine the efficacy of the new device.