Abstract
Cardiac surgical approaches require the development of new materials regardless of the polyurethanes used for pulsatile blood pumps; therefore, an innovative biomaterial, a copolymer of poly(ethylene terephthalate) and dimer fatty acid (dilinoleic acid) modified with D-glucitol, hereafter referred to as PET/DLA, has been developed, showing non-hemolytic and atrombogenic properties and resistance to biodegradation. The aim of this work was to evaluate in vivo inflammatory responses to intramuscular implantation of PET/DLA biomaterials of different compositions (hard to soft segments). Two copolymers containing 70 and 65 wt.% of hard segments, as in poly(ethylene terephthalate) and dilinoleic acid in soft segments modified with D-glucitol, were used for implantation tests to monitor tissue response. Medical grade polyurethanes Bionate II 90A and Bionate II 55 were used as reference materials. After euthanasia of animals (New Zealand White rabbits, n = 49), internal organs and tissues that contacted the material were collected for histopathological examination. The following parameters were determined: peripheral blood count, blood smear with May Grunwald–Giemsa staining, and serum C-reactive protein (CRPP). The healing process observed at the implantation site of the new materials after 12 weeks indicated normal progressive collagenization of the scar, with an indication of the inflammatory–resorptive process. The analysis of the chemical structure of explants 12 weeks after implantation showed good stability of the tested copolymers in contact with living tissues. Overall, the obtained results indicate great potential for PET/DLA in medical applications; however, final verification of its applicability as a structural material in prostheses is needed.
Highlights
The obtained results of the morphology, CRP, and the microscopic images of the peripheral blood throughout the observation period of the animals undergoing the procedure of implantation of the material were normal and fell within the range of reference values, which proves that the postoperative wound healing processes are correct
The response to implantation varied from the absence of any intramuscular changes to the presence of connective tissue scars that are most likely remnants of connective tissue capsule tissue, to the presence of a connective tissue capsule (40 cases; Figure 2A)
Fourier Transform Infrared Spectroscopy (FTIR) and Gel Permeation Chromatography (GPC) were used to test the biomaterial samples recovered after implantation
Summary
Materials used in the manufacture of implants and other medical devices must fulfill their intended function without causing any negative consequences for the patient. Medical devices or materials must have appropriate properties in terms of how they interact with the host organism (biocompatibility) and resistance to damaging effects of biological agents. For this reason, medical devices are typically subjected to biological evaluation and biocompatibility studies to evaluate the interaction between the device and the patient’s tissue, cells, or body fluids. The main objective of the device biocompatibility assessment is to protect the patient against potential threats that can result from contact with the medical device [1]. Biocompatibility requirements for medical devices and the biomaterials they are made from are set out in the ISO 10993 standard, “Biological evaluation of medical devices”
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
