Abstract
Problem
The objective is to develop an instrument which allows a drug-eluting catheter to be safely and reproducibly inserted into the ethmoid sinuses.
Methods
A trochar-based insertion device was designed to allow delivery of a drug-eluting catheter into the anterior and posterior ethmoid sinuses. It was inserted into 12 cadaveric ethmoid sinuses under endoscopic and fluoroscopic guidance. CT scans were performed pre-, intra-, and post-procedure. The device's position was analyzed and the proximity to the skull base, lamina papyracea, and ethmoid face was measured. The specimens were then dissected and evaluated for skull base, sphenoid face, or lamina papyracea injury.
Results
The drug eluting catheter system was successfully inserted into the ethmoid sinuses of all 12 cadaver sides without injury to either the medial orbital wall or the skull base as confirmed by post-procedure CT scan and dissection. The final position of the distal tip of the stent averaged 8.1mm (RMS = 3.3) from the skull base, 5.6mm (RMS=3.5) from the sphenoid face, and 5.0mm (RMS=3.5) from the lamina papyracea; the proximal tip was at the face of the ethmoid bulla and 17.1mm (RMS=3.5) below the skull base.
Conclusion
This study demonstrates that a trochar-based instrument can safely and reproducibly introduce a drug-eluting catheter into the ethmoid sinuses without skull base or lamina papyracea injury. This device may allow safe topical drug delivery into the ethmoid sinuses and provide chronic ethmoid sinusitis patients an alternative to ethmoidectomy.
Significance
The primary surgical therapy for chronic ethmoid sinusitis is ethmoidectomy; topical therapy has been widely used in the management of chronic ethmoid sinusitis only after ethmoidectomy. This study shows a drug-eluting catheter can be safely and reliably inserted into virgin ethmoid sinuses in order to allow the topical elution of medications into the ethmoids without ethmoidectomy.
Support
Acclarent supplied cadaveric specimens.
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