Small caliber arterial prosthesis: prototype and pre-industrialization

Cardiovascular diseases represent the leading cause of death in developed countries. Modern surgical methods show poor efficiency in the substitution of small-diameter arteries (< 6 mm). Due to the mismatch in mechanical properties between the native artery and the substitute, the behavior of the vessel wall remains a major cause of inefficient substitutions an unsolved complication in surgery since 1970. The purpose of this work was to obtain polylysine-enriched vascular substitutes, derived from decellularized porcine femoral and carotid arteries. Polylysine was selected as a matrix cross-linker, increasing the mechanical resistance of the scaffold with respect to decellularized vessels, without altering the native biocompatibility and haemocompatibility properties. The biological characterization showed excellent biological performances, while mechanical tests displayed that the Young’s modulus of the polylysine-enriched matrix was comparable to that of the native vessel. Concerning haemocompatibility, the performed analyses show that polylysine-enriched matrices increase coagulation time, with respect to commercial Dacron® vascular substitutes. Based on these findings, polylysine-enriched decellularized vessels resulted in a promising approach for vascular substitution. In order to consider the industrial phase, a business plan (BP) and the preengineering of the production reactor were developed in the present project. Is crucial to consider the scale-up process of the project from the initial stages to increase the chances of its success. In this way, the feasibility study will contemplate the viability of the project from an economic point of view thus, the BP is the most important document of the study. From an engineering point of view, the industrial production reactor is the heart of the plant, so designing it from the outset will allow considering costs and performing the necessary experiments for its final design.