Poly(lactide-co-ε-caprolactone) scaffold promotes equivalent tissue integration and supports skin grafts compared to a predicate collagen scaffold.

Dermal scarring from motor vehicle accidents, severe burns, military blasts, etc. is a major problem affecting over 80 million people worldwide annually, many of whom suffer from debilitating hypertrophic scar contractures. These stiff, shrunken scars limit mobility, impact quality of life, and cost millions of dollars each year in surgical treatment and physical therapy. Current tissue engineered scaffolds have mechanical properties akin to unwounded skin, but these collagen-based scaffolds rapidly degrade over 2 months, premature to dampen contracture occurring 6-12 months after injury. This study demonstrates a tissue engineered scaffold can be manufactured from a slow-degrading viscoelastic copolymer, poly(ι-lactide-co-ε-caprolactone), with physical and mechanical characteristics to promote tissue ingrowth and support skin-grafts. Copolymers were synthesized via ring-opening polymerization. Solvent casting/particulate leaching was used to manufacture 3D porous scaffolds by mixing copolymers with particles in an organic solvent followed by casting into molds and subsequent particle leaching with water. Scaffolds characterized through SEM, micro-CT, and tensile testing confirmed the required thickness, pore size, porosity, modulus, and strength for promoting skin-graft bioincorporation and dampening fibrosis in vivo. Scaffolds were Oxygen Plasma Treatment and collagen coated to encourage cellular proliferation. Porosity ranging from 70% to 90% was investigated in a subcutaneous murine model and found to have no clinical effect on tissue ingrowth. A swine full-thickness skin wound model confirmed through histology and Computer Planimetry that scaffolds promote skin-graft survival, with or without collagen coating, with equal safety and efficacy as a commercially available tissue engineered scaffold. This study validates a scalable method to create poly(ι-lactide-co-ε-caprolactone) scaffolds with appropriate characteristics and confirms in mouse and swine wound models that the scaffolds are safe and effective at supporting skin-grafts. The results of this study have brought us closer towards developing an alternative technology that supports skin grafts with the potential to investigate long-term hypertrophic scar contractures.

3D printing and characterization of a soft and biostable elastomer with high flexibility and strength for biomedical applications.

Recent advancements in 3D printing have revolutionized biomedical engineering by enabling the manufacture of complex and functional devices in a low-cost, customizable, and small-batch fabrication manner. Soft elastomers are particularly important for biomedical applications because they can provide similar mechanical properties as tissues with improved biocompatibility. However, there are very few biocompatible elastomers with 3D printability, and little is known about the material properties of biocompatible 3D printable elastomers. Here, we report a new framework to 3D print a soft, biocompatible, and biostable polycarbonate-based urethane silicone (PCU-Sil) with minimal defects. We systematically characterize the rheological and thermal properties of the material to guide the 3D printing process and have determined a range of processing conditions. Optimal printing parameters such as printing speed, temperature, and layer height are determined via parametric studies aimed at minimizing porosity while maximizing the geometric accuracy of the 3D-printed samples as evaluated via micro-CT. We also characterize the mechanical properties of the 3D-printed structures under quasistatic and cyclic loading, degradation behavior and biocompatibility. The 3D-printed materials show a Young's modulus of 6.9 ± 0.85 MPa and a failure strain of 457 ± 37.7% while exhibiting good cell viability. Finally, compliant and free-standing structures including a patient-specific heart model and a bifurcating arterial structure are printed to demonstrate the versatility of the 3D-printed material. We anticipate that the 3D printing framework presented in this work will open up new possibilities not only for PCU-Sil, but also for other soft, biocompatible and thermoplastic polymers in various biomedical applications requiring high flexibility and strength combined with biocompatibility, such as vascular implants, heart valves, and catheters.