Development of an endoluminal intestinal attachment for a clinically applicable distraction enterogenesis device

Abstract

Purpose Previous methods of distraction enterogenesis have relied upon blind-ending intestinal segments or transmural device fixation, requiring multiple operations and potential bowel injury. We hypothesized that using a novel attachment would allow reversible device coupling to the luminal bowel surface, achieving effective endoluminal distraction. Methods A telescopic hydraulic device was designed with latex balloon attachments covered with high-friction mesh and a dilating fenestrated elastic mask (DFM attachment), allowing mesh-to-mucosa contact only with inflation. Yorkshire pigs underwent jejunal Roux-en-Y limb creation and device placement via jejunostomy. Devices underwent 3 cycles of balloon inflation and hydraulic extension/retraction per day for 7 days and then explanted and studied for efficacy. Results DFM attachment allowed reversible, high-strength endoluminal coupling without tissue injury or reduction in bowel perfusion. After 7 day implant, distracted bowel achieved a 44±2% increase in length vs. fed, non-distracted bowel, corresponding to a gain of 7.1±0.3 cm. Distracted bowel demonstrated increased epithelial cell proliferation vs. control bowel. Attachment sites demonstrated villus flattening, increased crypt depth, thicker muscularis mucosa, and unchanged muscularis propria thickness vs. control. Conclusion Novel high-strength, reversible attachments enabled fully endoluminal distraction enterogenesis, achieving length gains comparable to open surgical techniques. This approach may allow development of clinically applicable technology for SBS treatment.

Expanding intestinal segment using osmotic hydrogel: An in vivo study

“…Recently, a variety of devices and operative approaches have been tested in animals for the treatment of SBS, but none of these approaches have been translated into clinical practice thus far. Self‐expanding, shape‐memory polymer cylinder, catheter device and a telescopic hydraulic device have all been tested, but their translations seem to be limited by the need for complex activation mechanisms or the surgical risks associated. These devices appeared challenging to use in a clinical scenario because of reported discomfort, pain and complications …”

“…To address this lack of dilatation recent studies on intestinal intraluminal devices have been proposed for the treatment of SBS, but currently their translation to clinical practice seems to be limited. Interestingly, the use of different devices as osmotic expanders have been popularized to increase the surface of several tissues such as; skin, soft tissue, or hypospadias cripples and has become the treatment of choice for many congenital and acquired defects; however, this technique has never been used to expand intestinal segments thus far.…”

New Insights and Interventions for Short Bowel Syndrome

“…Demerhi et al . showed that a novel device using hydraulic force to apply distraction can reliably lengthen porcine bowel in experimental settings [28–30]. This relied on a system where two balloons were placed within the bowel, which could be inflated to oppose the intestinal wall, and hydraulic distractive force was instilled in between these to achieve lengthening.…”

Three-dimensionally printed surface features to anchor endoluminal spring for distraction enterogenesis

“…Our laboratory demonstrated effective intestinal lengthening using spring-mediated distractive devices [ 15 – 21 ]. However, these models are limited by multiple surgeries to repeat intestinal lengthening, restore intestinal continuity, or require extraluminal attachments [ 15 , 18 , 20 , 22 – 23 ].…”