Sterilization effects on ultrathin film polymer coatings for silicon-based implantable medical devices

Citation

Iqbal, Z.; Moses, W.; Kim, S.; Kim, E. J.; Fissell, W. H.; & Roy, S. (2018). Sterilization effects on ultrathin film polymer coatings for silicon-based implantable medical devices. J Biomed Mater Res B Appl Biomater, 106(6), 2327-2336. PMCID: 5936672

Abstract

Novel biomaterials for medical device applications must be stable throughout all stages of preparation for surgery, including sterilization. There is a paucity of information on the effects of sterilization on sub-10 nm-thick polymeric surface coatings suitable for silicon-based bioartificial organs. This study explores the effect of five standard sterilization methods on three surface coatings applied to silicon: polyethylene glycol (PEG), poly(sulfobetaine methacrylate) (pSBMA), and poly (2-methacryloyloxyethyl phosphorylcholine) (pMPC). Autoclave, dry heat, hydrogen peroxide (H2 O2 ) plasma, ethylene oxide gas (EtO), and electron beam (E-beam) treated coatings were analyzed to determine possible polymer degradation with sterilization. Poststerilization, there were significant alterations in contact angle, maximum change resulting from H2 O2 (Delta - 14 degrees ), autoclave (Delta + 15 degrees ), and dry heat (Delta + 23 degrees ) treatments for PEG, pSBMA, and pMPC, respectively. Less than 5% coating thickness change was found with autoclave and EtO on PEG-silicon, E-beam on pSBMA-silicon and EtO treatment on pMPC-silicon. H2 O2 treatment resulted in at least 30% decrease in thickness for all coatings. Enzyme-linked immunosorbent assays showed significant protein adsorption increase for pMPC-silicon following all sterilization methods. E-beam on PEG-silicon and dry-heat treatment on pSBMA-silicon exhibited maximum protein adsorption in each coating subset. Overall, the data suggest autoclave and EtO treatments are well-suited for PEG-silicon, while E-beam is best suited for pSBMA-silicon. pMPC-silicon was least impacted by EtO treatment. H2 O2 treatment had a negative effect on all three coatings. These results can be used to determine which surface modifications and sterilization processes to utilize for devices in vivo. (c) 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2327-2336, 2018.

Keyword(s)

*Equipment and Supplies
*Membranes, Artificial
*Prostheses and Implants
Humans
Silicon/*chemistry
Sterilization/*methods

Notes

Iqbal, Zohora
Moses, Willieford
Kim, Steven
Kim, Eun Jung
Fissell, William H
Roy, Shuvo
P41 EB002027/EB/NIBIB NIH HHS/
R01 EB014315/EB/NIBIB NIH HHS/
U01 EB021214/EB/NIBIB NIH HHS/
J Biomed Mater Res B Appl Biomater. 2018 Aug;106(6):2327-2336. doi: 10.1002/jbm.b.34039. Epub 2017 Nov 6.

Reference Type

Journal Article

Secondary Title

J Biomed Mater Res B Appl Biomater

Author(s)

Iqbal, Z.
Moses, W.
Kim, S.
Kim, E. J.
Fissell, W. H.
Roy, S.

Year Published

2018

Date Published

1533081600

Volume Number

106

Issue Number

6

Pages

2327-2336

ISSN/ISBN

1552-4981 (Electronic)
1552-4973 (Linking)

DOI

10.1002/jbm.b.34039

PMCID

5936672