Marvin Ryou, MD1, David B Lautz, MD2, Christopher C Thompson, MD, MHES1. 1Brigham & Women’s Hospital, 2Emerson Hospital
Introduction: A minimally invasive method of gastrointestinal bypass would be desirable for treatment of obstruction, obesity, or metabolic syndrome. We have developed a technology based on miniature self-assembling magnets which create large-caliber anastomoses (Incisionless Anastomosis System or IAS). The IAS was previously shown to produce a widely patent, durable jejuno-colonic anastomosis in a porcine survival model.
The IAS magnets can be deployed into a lumen endoscopically or laparoscopically. The IAS magnet self-assembles into an octagonal macro-magnet which then couples with an identical macro-magnet deployed in an adjacent lumen. The magnets form a large anchored window for immediate bypass if desired. Otherwise, magnetic compression over several days creates a robust durable anastomosis, and the fused magnets are naturally expelled.
Aims: To evaluate and develop procedural characteristics of IAS deployment for jejuno-ileal side-to-side anastomosis creation in the human cadaveric model
Methods: Endoscopic jejuno-ileal bypass creation using IAS magnets was attempted in 8 human cadavers (5 male, 3 female). Laparoscopy was initially performed for lysis of adhesions. The jejunum and ileum were stapled to minimize intestinal distension. Upper enteroscopy was performed using a standard colonoscope. Lower ileoscopy was performed using a pediatric colonoscope through a spiral overtube (Spirus). IAS magnets were deployed in their respective lumens and manipulated under both endoscopic and fluoroscopic guidance. Various patient position changes were employed to facilitate IAS magnet coupling. If IAS magnets could not be endoscopically coupled, the IAS magnets were instead laparoscopically coupled.
Results: Jejuno-ileal bypass creation using self-assembling IAS magnets was successful in the final 4 of 8 cadavers, reflecting a substantial learning curve. Initial unsuccessful cases were due to: excessive insufflation of the intestines (eventually corrected with intestinal stapling since CO2 insufflation was not possible in a cadaveric model); unsuccessful IAS magnet deployment (early magnet iteration, later optimized); inability to achieve deep ileoscopy due to redundant colon in cadaver. In all cases of unsuccessful endoscopic coupling, laparoscopic rescue coupling was easily performed. In the final 4 successful endoscopic cases, the following procedural characteristics appeared important: supine positioning, insufflation of the bowel and fluoroscopic visualization.
Conclusions: Purely endoscopic jejuno-ileal bypass creation using self-assembling IAS magnets is technically feasible. This human cadaveric study underscored the simultaneous contributions of prototype refinement, optimal patient positioning, and identification of key procedural steps towards the development of a novel procedure. Additionally, the IAS magnets lend themselves to a combined endoscopic/laparoscopic approach, purely laparoscopic strategy or an endoscopic-only delivery method.