Description of the AeroForm CO2-Based Tissue Expander and Assessment of the Effect of Pressurized Cabin Air Travel

Background: Tissue expanders are used in breast reconstruction after mastectomy to create a space for placement of permanent breast implants. The AeroForm™ Tissue Expander, developed by AirXpanders™ Inc., utilizes carbon dioxide released from an internal reservoir to inflate the expander. The released gas is contained within a high barrier material pre-formed into a breast shaped shell of the desired volume. During patient travel to higher altitude, a partially inflated expander will increase in volume proportionately to the gas fill volume. At volume levels near full, expansion is governed by the compliance of the inner gas barrier and silicone shell. Therefore, the assessment of the expander performance at altitude consists of the analysis of two operating regimes. The first regime is fill levels < 70% full where the implant, when exposed to cabin pressure, expands without significantly stressing the inner gas barrier. The second is fill levels ~>70% where the response of the inner gas barrier is important, both in terms of structural capability and determination of the volume increase. We assessed the impact of pressurized flight on expander performance in both operating regimes. Findings: The volume increase associated with altitude increase to 8000 feet (maximum cabin altitude per FAA) is typically within the range administered during post-operative fills of saline expanders. Although assessment must be conducted by a clinician, a patient can be typically expected to tolerate the increased volume with some minor discomfort, such as a feeling of tightness. At higher fill levels, the structural capability of shell has been demonstrated to withstand the additional pressure loading. At these fill levels, the expander does not expand as much, due to the structural restraint of the shell. To date, 7 subjects have flown with the expander in situ during clinical trials. All subjects were required to temporarily cease dosing up to two weeks prior. Flight travel was completed uneventfully and they reported discomfort levels ranging from none to moderate. The recommendation to cease dosing two weeks prior to flying was made to allow the expected 1 cc per day of CO2 permeation to occur, which will result in slight deflation to accommodate for the expansion of the CO2 when flying. As expected, subjects reported a sensation of pressure upon ascent which subsided on descent.