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

Author(s) :

M'bengue, Marie-Stella [Auteur]
Unité Matériaux et Transformations - UMR 8207 [UMET]
Advanced Drug Delivery Systems (ADDS) - U1008
Mesnard, Thomas [Auteur]
Médicaments et biomatériaux à libération contrôlée: mécanismes et optimisation - Advanced Drug Delivery Systems - U 1008 [MBLC - ADDS]
Institut Coeur Poumon [CHU Lille]
Chai, Feng [Auteur]
Médicaments et biomatériaux à libération contrôlée: mécanismes et optimisation - Advanced Drug Delivery Systems - U 1008 [MBLC - ADDS]
Maton, Mickael [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Gaucher, Valerie [Auteur]
Unité Matériaux et Transformations (UMET) - UMR 8207
Tabary, Nicolas [Auteur]
Unité Matériaux et Transformations (UMET) - UMR 8207
Garcia Fernandez, Maria Jose [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008
Sobocinski, Jonathan [Auteur]
Institut Coeur Poumon [CHU Lille]
Advanced Drug Delivery Systems (ADDS) - U1008
Martel, Bernard [Auteur]
Unité Matériaux et Transformations (UMET) - UMR 8207
Blanchemain, Nicolas [Auteur]
Advanced Drug Delivery Systems (ADDS) - U1008

Journal title :

Pharmaceutics

Abbreviated title :

Pharmaceutics

Volume number :

15

Pages :

456

Publisher :

MDPI AG

Publication date :

2023-01-30

ISSN :

1999-4923

English keyword(s) :

medical device
3D printing
polyurethane
sterilization
biocompatibility

HAL domain(s) :

Chimie/Matériaux
Chimie/Polymères

English abstract : [en]

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 ...
Show more >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 (γ) sterilized 3DP constructs. To the authors’ 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 < 0.05). After gamma sterilization, Mw increased by 8% (p < 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% ± 3%, p < 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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CNRS
INRAE
ENSCL

Collections :

• Advanced Drug Delivery Systems (ADDS) - U1008
• Unité Matériaux et Transformations (UMET) - UMR 8207

Research team(s) :

Ingénierie des Systèmes Polymères

Submission date :

2023-01-31T07:45:48Z
2023-02-03T09:09:45Z