Invited Paper BI-TuE1
Challenges in Translating Surface Designs to Clinical Medical Device Applications

Tuesday, December 13, 2016, 5:40 pm, Room Milo

Surface strategies for translational clinical performance for 1) medical devices with antimicrobial properties, and 2) nanomaterials in imaging and drug delivery are discussed.

1. Antimicrobial medical devices.[1-5] Increasing medical devices are used in clinical implants: in aging populations, diverse patient genetic profiles, ethnicity and health status, and increasing developing countries. Notably, infection related to implanted devices is a primary concern both for patient risk and healthcare cost reasons. Medical device surfaces and interfaces have long been a focus to produce diverse antimicrobial strategies, yet few translate to clinical use. A classic problem is lack of in vitro-in vivo correlation, validation or efficacy for surface methods and antimicrobial approach in vivo. A second issue is lack of commercial enthusiasm to take approaches forward thru regulatory pathways to clinical use. Improved methods are required to assess and validate new antimicrobial technologies that reduce implant-associated infections and risks in translation.

2. Nanomaterials exposure to the human physiome.[6-10] Human exposure to engineered nanotechnology is an increasing concern. Importantly, medical grade standards of purity and contamination validation and analysis are difficult for nanomaterials and not commonly followed in most in vivo studies. Since surface area is critical nanomaterials property, surface analysis is critical but rarely performed.[6] Much published data demonstrate that particles placed in blood circulation are rapidly filtered by the reticuloendothelial system (RES) comprising liver, spleen, lung, kidney, and marrow, performing blood scavenging. Particle removal is mostly independent of size or chemistry, and refractory to targeting strategies by coatings. Wide variations in circulating nanomaterials properties produce quite similar results in mammalian biodistributions and RES clearance (>90% RES filtration). Issues with connecting nanomaterials surface properties to complex biological interactions will be discussed.

References:

1. Busscher et al., Sci. Transl. Med. 4, 153rv10 (2012).

2. Grainger et al., Biomaterials, 34:9237 (2013).

3. Moriarty et al., Eur. Cells Mater. 28:112 (2014).

4. Brooks et al., in ‪Biomaterials Associated Infection, Springer, NY 2012.

5. Wu and Grainger, Biomaterials, 27:2450 (2006).

6. Grainger and Castner, Adv. Mater. 20:867 (2008).

7. Jones and Grainger, Adv. Drug Deliv.Rev. 61:438 (2009).

8. Grainger, Adv. Drug Deliv. Rev. 61:419 (2009).

9. Grainger, Int. J. Pharm, (2013) 454:521.

10. Wang and Grainger, Front. Chem. Sci. Eng, (2014) 8:265.