Analysis of Pressure Distribution

Force-Directional Balloon Dilation in Sinonasal Surgery: Evaluating Pressure Distributions Using Pressure-Sensitive Film

Authors: David Joseph Dillard, James K. Fortson MD, MBA, MPH, CPE

Short Title (≤100 characters): Force-Directional Balloon Dilation Pressure Distributions

Abstract Body: 

Objective: To evaluate pressure distribution characteristics of a novel force-directional balloon (FDB) dilation device designed for office-based septoplasty compared to the conventional non-directional balloon.

Study Design: Experimental bench-top study.

Setting: Mechanical testing laboratory.

Methods: Two steel plates lined with artificial mucosa were spaced 7 to 9 mm apart and covered with Fuji Prescale pressure-sensitive film (PSF). Each balloon configuration, including the traditional unguided balloon, the FDB with integrated spatula, and the FDB with simulated surgeon-applied pressure, was positioned between the plates and inflated to 10 ATM with saline. Imprints on the PSF were analyzed using Topaq Computerized Analysis to quantify total contact area, minimum, maximum, average pressure, estimated force (EF), and three dimensional pressure modeling (3DPM). 

Results: Without simulated surgeon pressure, the FDB balloon side produced an average pressure of 143.7 psi (range 73.2- 361.5 psi), and an EF of 61.4 lbf, whereas the FDB spatula-protected side (SPS) showed 115.2 psi (73.2-342.4 psi) and an EF of 43.8 lbf, representing a 40.2% reduction in total force output. With simulated surgeon pressure, the SPS demonstrated a 73.4% reduction compared with the balloon side. The unguided balloons showed symmetrical pressure distributions between the plates. Topaq 3DPM modeling revealed an ovoid, peripheral pressure pattern with lower pressures centrally. 

Conclusion: The FDB produced significantly asymmetrical pressure profiles that concentrated expansion forces toward the septal side while reducing lateral wall stress. This directional force pattern may lower the risk of injury to adjacent structures such as the orbit and skull base compared with traditional unguided balloons. Further cadaveric and clinical studies are needed to validate these findings.