CO2-based tissue expansion: a study of initial performance in ovine subjects

Area of Science:

• Biomedical Engineering
• Surgical Innovation
• Reconstructive Surgery

Background:

• Tissue expanders are crucial for reconstructive surgery, particularly in breast reconstruction.
• Current saline-based expansion is time-consuming and requires frequent patient visits.
• Needle-free technology can reduce patient discomfort and improve resource efficiency.

Purpose of the Study:

• To evaluate a novel, controlled, needle-free CO(2)-based tissue expansion system.
• To assess in vivo communication between CO(2) expanders and dosage controllers.
• To determine the expanders' ability to reach target volumes.

Main Methods:

• Twelve CO(2) tissue expanders of varying sizes were implanted in two ovine models.
• Daily CO(2) expansion was administered using paired handheld dosage controllers.
• Device performance, expansion rates, and animal well-being were monitored; explants were examined post-procedure.

Main Results:

• All 12 paired devices functioned as specified, achieving successful, needle-free expansion.
• Explanted expanders confirmed accurate expansion to labeled volumes.
• Full expansion was achieved rapidly (11-13 days), with no adverse events reported.

Conclusions:

• The CO(2)-based tissue expansion system is a promising tool for reconstructive surgery.
• In vivo testing in an ovine model confirmed the system's safety and efficacy.
• This needle-free approach has the potential to expedite tissue expansion and simplify patient care.