Application of in-body tissue architecture-induced Biotube vascular grafts for vascular access: Proof of concept in a beagle dog model.

INTRODUCTION

The first choice of vascular access for hemodialysis is an autogenous arteriovenous fistula, because prosthetic arteriovenous grafts have a high probability of failure. In this study, Biotubes, in-body tissue architecture-induced autologous collagenous tubes, were evaluated for their potential use as vascular access grafts. Three animal implantation models were developed using beagle dogs, and the in vivo performance of Biotubes was observed after implantation in the acute phase as a pilot study.

METHODS

Biotubes (internal diameter ca. 4.0 mm, length ca. 5.0 cm, and wall thickness ca. 0.7 mm) were prepared through subcutaneous embedding of specially designed molds in beagle dogs for 8 weeks. The Biotubes were then implanted between the common carotid artery and the jugular vein of beagles via three methods, including side-to-side (in) -end-to-end (out) as type 1 (n = 4), side-to-side (both) as type 2 (n = 4), and side-to-end (in) -end-to-side (out) as type 3 (n = 1 using a composite Biotube).

RESULTS

Although two cases in type 1 and 2 resulted in Biotube deformation, all cases were patent for 4 weeks and maintained a continuous turbulent flow. At 4 weeks after implantation, percutaneous puncture could be performed repeatedly without aneurysm formation or hemorrhage.

CONCLUSION

Within a short implantation period, with limited animal numbers, this proof-of-concept study showed that Biotubes may have a high potential for use in vascular access.