Development of a novel tissue-engineered nitinol frame artificial trachea with native-like physical characteristics

Tracheal reconstruction is complicated by the short length to which a trachea can be resected. We previously developed a biocompatible polypropylene frame artificial trachea, but it lacked the strength and flexibility of the native trachea. In contrast, nitinol may provide these physical characteristics. We developed a novel nitinol frame artificial trachea and examined its biocompatibility and safety in canine models.

We constructed several nitinol frame prototypes and selected the frame that most closely reproduced the strength of the native canine trachea. This frame was used to create a collagen-coated artificial trachea that was implanted into 5 adult beagle dogs. The artificial trachea was first implanted into the pedicled omentum and placed in the abdomen. Three weeks later, the omentum-wrapped artificial trachea was moved into the thoracic cavity. The thoracic trachea was then partially resected and reconstructed using the artificial trachea. Follow-up bronchoscopic evaluation was performed, and the artificial trachea was histologically examined after the dogs were sacrificed.

Stenosis at the anastomosis sites was not observed in any dog. Survival for 18 months or longer was confirmed in all dogs but 1, which died after 9 months due to reasons unrelated to the artificial trachea. Histological examination confirmed respiratory epithelial regeneration on the artificial trachea's luminal surface. Severe foreign body reaction was not detected around the nitinol frame.

The novel nitinol artificial trachea reproduced the physical characteristics of the native trachea. We have confirmed cell engraftment, good biocompatibility, and survival of 18 months or longer for this artificial trachea in canine models.