Anisotropic hydrostatic intraluminal esophageal stretch: Prototyping and initial testing in vivo
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Topic overview
Abstract
Background
We sought to fabricate and perform initial safety testing of a hydrostatic device for intraluminal axial distension of the esophagus, as a minimally invasive means of inducing esophageal stretch/lengthening.
Methods
The device consists of a modified infant endotracheal tube fitted with a unique anisotropically expandable balloon at its distal end. Structural integrity and functional parameters of the prototypes were measured in an expansion test rig. Subsequently, the impact of balloon inflation pressures on esophageal perfusion was examined in lambs (n = 6) with surgically created esophageal atresia. The device was placed in the proximal esophageal pouch and its intraluminal pressures were correlated with esophageal perfusion as assessed with a microvascular oximeter based on resonance Raman spectroscopy of hemoglobin. Statistical analyses included repeated measures with generalized estimating equations and inverse regression.
Results
The helicoidal architecture of the balloon led to consistent anisotropic expansion, with a stable relationship between balloon length, body width, and tip radius during liquid-based expansion within the test rig. There was a significant decrease in oxygen saturation in the esophageal wall at intraluminal pressures ≥30 mmHg (Pearson r = −0.58, Wald test = 17.5, p = 0.027). Regression analysis identified that an intraluminal pressure of 32 mmHg correlated with oxygen saturations below 60% (p
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