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Hydrostatic High-Pressure Post-Processing of Specimens Fabricated by DLP, SLA, and FDM: An Alternative for the Sterilization of Polymer-Based Biomedical Devices.

ABSTRACT: In this work, we assess the effects of sterilization in materials manufactured using additive manufacturing by employing a sterilization technique used in the food industry. To estimate the feasibility of the hydrostatic high-pressure (HHP) sterilization of biomedical devices, we have evaluated the mechanical properties of specimens produced by commercial 3D printers. Evaluations of the potential advantages and drawbacks of Fused Deposition Modeling (FDM), Digital Light Processing (DLP) technology, and Stereolithography (SLA) were considered for this study due to their widespread availability. Changes in mechanical properties due to the proposed sterilization technique were compared to values derived from the standardized autoclaving methodology. Enhancement of the mechanical properties of samples treated with Hydrostatic high-pressure processing enhanced mechanical properties, with a 30.30% increase in the tensile modulus and a 26.36% increase in the ultimate tensile strength. While traditional autoclaving was shown to systematically reduce the mechanical properties of the materials employed and damages and deformation on the surfaces were observed, HHP offered an alternative for sterilization without employing heat. These results suggest that while forgoing high-temperature for sanitization, HHP processing can be employed to take advantage of the flexibility of additive manufacturing technologies for manufacturing implants, instruments, and other devices.

SUBMITTER: Linares-Alvelais JAR

PROVIDER: S-EPMC6316578 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Hydrostatic High-Pressure Post-Processing of Specimens Fabricated by DLP, SLA, and FDM: An Alternative for the Sterilization of Polymer-Based Biomedical Devices.

Linares-Alvelais José A Robles JAR Figueroa-Cavazos J Obedt JO Chuck-Hernandez C C Siller Hector R HR Rodríguez Ciro A CA Martínez-López J Israel JI

Materials (Basel, Switzerland) 20181213 12

In this work, we assess the effects of sterilization in materials manufactured using additive manufacturing by employing a sterilization technique used in the food industry. To estimate the feasibility of the hydrostatic high-pressure (HHP) sterilization of biomedical devices, we have evaluated the mechanical properties of specimens produced by commercial 3D printers. Evaluations of the potential advantages and drawbacks of Fused Deposition Modeling (FDM), Digital Light Processing (DLP) technolo ...[more]

PMID: 30551631

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Project description:ObjectivesTo assess changes in quality of life after laparoscopic removal of Essure® sterilization devices (Bayer AG, Leverkusen, Germany).Study designIn this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure® devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study.ResultsHealth related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10 cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/-1.19) vs. 49.61 (+/-1.42, P < .0001) and 36.55 (+/-0.99) vs. 43.32 (+/-1.18, P < .0001 respectively) as well as global VAS assessment (+2.91 (SD +/-0.27)) at the end of the first post-operative month. These improvements were maintained at three and six months. Mean pain decreased at one month following surgery compared to baseline (VAS 3.6 (+/-0.36) to 1.4 (+/-0.25), P < .0001 and McGill pain score 18.70 (+/-1.88) to 4.73 (+/-0.90), P < .0001). Improvements of a similar magnitude were observed when analysis was restricted to the 47 women without concomitant uterine surgery. No significant changes in bleeding were seen following of Essure® device removal. Planned procedures were all successfully completed.ConclusionLaparoscopic removal of Essure® devices in symptomatic women is technically successful and associated with short and medium-term improvement in quality of life as well as reduction in pelvic pain.

Dataset Information

Hydrostatic High-Pressure Post-Processing of Specimens Fabricated by DLP, SLA, and FDM: An Alternative for the Sterilization of Polymer-Based Biomedical Devices.

Publications

Hydrostatic High-Pressure Post-Processing of Specimens Fabricated by DLP, SLA, and FDM: An Alternative for the Sterilization of Polymer-Based Biomedical Devices.

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