Rapid prototyped sutureless anastomosis device from self-curing silk bio-ink.

Sutureless anastomosis devices are designed to reduce surgical time and difficulty, which may lead to quicker and less invasive cardiovascular anastomosis. The implant uses a barb-and-seat compression fitting composed of one male and two female components. The implant body is resorbable and capable of eluting heparin. Custom robotic deposition equipment was designed to fabricate the implants from a self-curing silk solution. Curing did not require deleterious processing steps but devices demonstrated high crush resistance, retention strength, and leak resistance. Radial crush resistance is in the range of metal vascular implants. Insertion force and retention strength of the anastomosis was dependent on fit sizing of the male and female components and subsequent vessel wall compression. Anastomotic burst strength was dependent on the amount of vessel wall compression, and capable of maintaining higher than physiological pressures. In initial screening using a porcine implant, the devices remained intact for 28 days (the length of study). Histological sections revealed cellular infiltration within the laminar structure of the male component, as well as at the interface between the male and female components. Initial degradation and absorption of the implant wall were observed. The speed per anastomosis using this new device was much faster than current systems, providing significant clinical improvement.