{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T22:15:21Z","timestamp":1792188921888,"version":"4.4.0"},"reference-count":35,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T00:00:00Z","timestamp":1675036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"University of Lille North Europe","award":["federate-R-Expand-18-013"],"award-info":[{"award-number":["federate-R-Expand-18-013"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Three-dimensional printing (3DP) of thermoplastic polyurethane (TPU) is gaining interest in the medical industry thanks to the combination of tunable properties that TPU exhibits and the possibilities that 3DP processes offer concerning precision, time, and cost of fabrication. We investigated the implementation of a medical grade TPU by fused deposition modelling (FDM) for the manufacturing of an implantable medical device from the raw pellets to the gamma (\u03b3) sterilized 3DP constructs. To the authors\u2019 knowledge, there is no such guide\/study implicating TPU, FDM 3D-printing and gamma sterilization. Thermal properties analyzed by differential scanning calorimetry (DSC) and molecular weights measured by size exclusion chromatography (SEC) were used as monitoring indicators through the fabrication process. After gamma sterilization, surface chemistry was assessed by water contact angle (WCA) measurement and infrared spectroscopy (ATR-FTIR). Mechanical properties were investigated by tensile testing. Biocompatibility was assessed by means of cytotoxicity (ISO 10993-5) and hemocompatibility assays (ISO 10993-4). Results showed that TPU underwent degradation through the fabrication process as both the number-averaged (Mn) and weight-averaged (Mw) molecular weights decreased (7% Mn loss, 30% Mw loss, p &lt; 0.05). After gamma sterilization, Mw increased by 8% (p &lt; 0.05) indicating that crosslinking may have occurred. However, tensile properties were not impacted by irradiation. Cytotoxicity (ISO 10993-5) and hemocompatibility (ISO 10993-4) assessments after sterilization showed vitality of cells (132% \u00b1 3%, p &lt; 0.05) and no red blood cell lysis. We concluded that gamma sterilization does not highly impact TPU regarding our application. Our study demonstrates the processability of TPU by FDM followed by gamma sterilization and can be used as a guide for the preliminary evaluation of a polymeric raw material in the manufacturing of a blood contacting implantable medical device.<\/jats:p>","DOI":"10.3390\/pharmaceutics15020456","type":"journal-article","created":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T08:28:23Z","timestamp":1675067303000},"page":"456","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["Evaluation of a Medical Grade Thermoplastic Polyurethane for the Manufacture of an Implantable Medical Device: The Impact of FDM 3D-Printing and Gamma Sterilization"],"prefix":"10.3390","volume":"15","author":[{"given":"Marie-Stella","family":"M\u2019Bengue","sequence":"first","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"},{"name":"Univ. Lille, CNRS, INRAE, Centrale Lille, UMR 8207\u2014UMET\u2014Unit\u00e9 Mat\u00e9riaux et Transformations, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Mesnard","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"},{"name":"Institut Coeur Poumon, Regional Hospital Center University of Lille (CHRU Lille), 2 Avenue Oscar Lambret, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Chai","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micka\u00ebl","family":"Maton","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1862-5004","authenticated-orcid":false,"given":"Val\u00e9rie","family":"Gaucher","sequence":"additional","affiliation":[{"name":"Univ. Lille, CNRS, INRAE, Centrale Lille, UMR 8207\u2014UMET\u2014Unit\u00e9 Mat\u00e9riaux et Transformations, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9237-0196","authenticated-orcid":false,"given":"Nicolas","family":"Tabary","sequence":"additional","affiliation":[{"name":"Univ. Lille, CNRS, INRAE, Centrale Lille, UMR 8207\u2014UMET\u2014Unit\u00e9 Mat\u00e9riaux et Transformations, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1918-616X","authenticated-orcid":false,"given":"Maria-Jos\u00e9","family":"Garc\u00eda-Fernandez","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Sobocinski","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"},{"name":"Institut Coeur Poumon, Regional Hospital Center University of Lille (CHRU Lille), 2 Avenue Oscar Lambret, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Martel","sequence":"additional","affiliation":[{"name":"Univ. Lille, CNRS, INRAE, Centrale Lille, UMR 8207\u2014UMET\u2014Unit\u00e9 Mat\u00e9riaux et Transformations, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Blanchemain","sequence":"additional","affiliation":[{"name":"Univ. Lille, INSERM, CHU Lille, U1008\u2014Advanced Drug Delivery Systems and Biomaterials, F-59000 Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,1,30]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"122116","DOI":"10.1016\/j.cej.2019.122116","article-title":"Heparin coating on 3D printed poly (l-lactic acid) biodegradable cardiovascular stent via mild surface modification approach for coronary artery implantation","volume":"378","author":"Lee","year":"2019","journal-title":"Chem. Eng. J."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"355","DOI":"10.1016\/j.matlet.2014.11.119","article-title":"In vivo evaluation and characterization of a bio-absorbable drug-coated stent fabricated using a 3D-printing system","volume":"141","author":"Park","year":"2015","journal-title":"Mater. 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