Society for Biomaterials: Biomaterial Applications in Today’s Industry: Development, Translation & Commercialization: Society for Biomaterials: Applications in Today's Healthcare Industry
Program Organizers: Bob Hastings, Depuy Synthes, J&J; SuPing Lyu, Medtronic
Monday 8:00 AM
October 10, 2022
Room: 317
Location: David L. Lawrence Convention Center
Session Chair: SuPing Lyu, Medtronic
8:00 AM Invited
Polymer Material Applications in Medical Devices: SuPing Lyu1; 1Medtronic
Biomedical devices span a broad range from surgical tools, implantable cardiac pacemakers, to drug eluting stents. Hundreds of millions of patients have been helped each year for alleviating pain, restoring health, or extending life. The materials that are used to manufacture those biomedical products are generally called biomaterials. It may be thought the biomaterials have some biological signatures so that they are different from the commercial materials. In reality, most of the biomaterials used today were originally borrowed from commercial materials, such as Dacron, stainless steel, polyurethane, etc. They are essentially the same materials as those used for making other products such as space shuttles, paints, toys, etc. However, there are some differences in manufacturing, quality control, and evaluation for biological applications. Those differences and the technologies to manage the differences make commercial materials biomaterials. This presentation will introduce some polymers used in to produce medical devices to the audience.
8:30 AM Invited
Thermoplastic Polyurethanes in Medical Applications: Nathan Rohner1; Anthony Walder1; Michael Wiggins1; 1Lubrizol
Although commonly used in medical applications today, thermoplastic polyurethanes (TPU) were originally developed for non-medical applications. In the 1960-70’s medical device designers discovered polyurethanes’ properties (mechanical strength, tunable flexibility, versatile processability, inherent biocompatibility) made them an attractive medical device material. The selection of materials for medical device use is more important than ever, given evolving regulatory standards driving toward robust biocompatibility, chemical characterization, quality control and change management. Lubrizol Life Science Health’s innovation team is dedicated to advancing medical TPUs with a focus on enhanced processing, differentiated performance, and biocompatibility.
9:00 AM Invited
Predicting Patient Exposure to Medical Device Leachables: David Saylor1; 1U.S. Food and Drug Administration
Medical device materials contain chemicals that may pose toxicological concern(s) if released in sufficient quantities. Toxicological risk assessment approaches are increasingly being used in lieu of animal testing to address these concerns. Currently, these approaches rely primarily on in vitro extraction testing to estimate the potential for patients to be exposed to chemicals that may possibly leach out of device materials, but the clinical relevance of the test results are often ambiguous. Recent developments suggest physics-based models can be used to provide more clinically relevant exposure estimates. However, the lack of data available to parameterize and validate these models presents a barrier to routine use. This presentation will provide an overview of these approaches, including potential benefits and limitations of current models, and key technical challenges to expanding the applicability and improving the clinical relevance of the model predictions.
9:30 AM Invited
Metallic Materials Application in Medical Devices: Bernie Li1; 1Medtronic
Metallic materials have been used in medical devices for more than 40 years. The active medical devices need metals meet biocompatibility, corrosion, forming, fatigue and electrical requirements. Pacemakers and Implantable Neuro stimulators such as deep brain stimulators, pain stimulators use Titanium sheets or strips for shield. Cobalt alloy and Platinum alloys are used for leads application. The form of the metals used in the devices includes fine wires, strips, rod and plate. Due to the different shape and size of the alloy, the materials properties can be very different from the alloys in industrial application. Some of them are not included in ASTM standard. These alloys have to have welded to different pieces or have to expose to elevated temperature for additional process. These additional processes modify the property of the alloys. In this presentation, it introduces alloy application in medical devices with different alloys and process effect on alloys.
10:00 AM
Murata’s NeuroStoneTM Free-Form Inter-Connected Ceramic Technology for Medical Applications: Mark Waugh1; Seth Berbano1; Mike Cannon1; Faycal Mounaim1; Takumi Okashiro2; Shu Hamada2; 1Murata Electronics North America, Inc.; 2Murata Manufacturing Co., Ltd.
3D printing innovations for medical applications are happening at break-neck speed, enabling increased complexity to custom designs and manufacturing. However, applications like electrophysiology catheters, ablation catheters, disposable endoscopy, and capsule endoscopy are still facing electrical, mechanical, and assembly challenges. Murata’s NeuroStoneTM technology and process leverages Additive Manufacturing and Low Temperature Co-fired Ceramics expertise. NeuroStoneTM was specifically developed to enable unique, minimally invasive designs to be quickly and easily adopted in prototypes and products (Hirao et al., Ahmmed et al.). Additional benefits include flexibility to address application constraints, multi-directional interconnect freedom, electrode packing density, and higher reliability. NeuroStoneTM technology can contribute to innovative medical therapies with more complex and multi-functional devices thanks to simplified structures and solutions leading to cost reduction, shorter time-to-market, and wider adoption.This presentation will cover NeuroStoneTM’s above benefits and how collaboration of design support, product customization, and integration is overcoming technical issues to improve patient care.
10:20 AM Break
10:40 AM
Silicon Nitride-infused Fabrics Exhibit Antiviral Behavior: Brittany Heath1; Chelsey McMinn2; Sherry Van Mondfrans2; Jackson Hendry2; Sean Ronayne2; Douglas Hoxworth2; B. Sonny Bal2; Bryan McEntire2; Kylene Kehn-Hall1; Ryan Bock2; 1Virginia Polytechnic Institute and State University; 2SINTX Technologies
Active anti-microbial agents capable of inactivating a wide range of pathogens without presenting toxicity hazards are needed for use in durable and reusable medical personal protective equipment. Silicon nitride, a ceramic commercialized as a spinal implant material, has previously demonstrated antibacterial and antifungal activity in a monolithic form. In this study, α- and β-phase silicon nitride powders were subjected to physicochemical characterization, cytotoxicity testing using Vero cells, and a viral inactivation assay based on the ISO 18184 protocol using SARS-CoV-2. Spunbond polypropylene fabrics infiltrated with α-silicon nitride were also characterized and subjected to the same cytotoxicity and viral inactivation protocols. A concentration- and exposure time-dependent antiviral response was observed for both powders, which did not exhibit evidence of cytotoxicity at concentrations below 20% (w/v). Nitride-infiltrated fabric also demonstrated antiviral behavior that intensified as powder loading and exposure time were increased.
11:00 AM
Evaluation of Antibacterial Silicon Nitride Powder and Infiltrated Fabrics: Chelsey McMinn1; Sherry Van Mondfrans1; Jackson Hendry1; Sean Ronayne1; Douglas Hoxworth1; Bryan McEntire1; B. Bal1; Ryan Bock1; 1SINTX Technologies
As part of an effort to create an active antimicrobial fabric, two silicon nitride powders, α- and β-phase, were morphologically characterized and assessed for antibacterial activity using ASTM E2149. The α-phase powder was infiltrated into spunbond polypropylene fabric using two different processes – a wet slurry method and a commercial dry alternating electric field process. The infiltrated fabrics were characterized using visible light microscopy and scanning electron microscopy prior to being subjected to ASTM E2149 and AATCC TM100 test protocols to determine their respective antibacterial properties. Silicon nitride powders consistently exhibited 2-log or better bacterial colony forming unit reductions, which improved as a function of exposure time and powder concentration. Infiltrated spunbond polypropylene fabrics also demonstrated antibacterial activity that varied as a function of silicon nitride loading on the fabrics, exposure time, and other parameters inherent to the two standard test methods.
11:20 AM Invited
Optimized Nanopatterned Electrodes for Enhanced Electrochemical Biosensors: Emily Kinser1; 13M Company
The benefits of nanotopography as a means of performance enhancement have been demonstrated across multiple biosensing methodologies and materials sets. To expand the potential applications of nanopatterned biosensors, biocompatible nanopatterned structures which are highly uniform and reliable are required. An optimized nanopatterned electrode structure consisting of nanorods with a gold core combined with an active platinum surface layer was created, which enabled demonstration of electrochemical sensing of glucose with increased signal and sensitivity. Arrays of nanorods with varying pitch were also fabricated in order to study the influence of nanorod pitch on biosensor performance. Additionally, interaction of fibroblast cells with the nanopatterned substrates with varying nanorod pitch was assessed utilizing FIB-SEM microscopy. With manufacturability as a key consideration, the nanopatterned electrodes were fabricated utilizing established commercial semiconductor-compatible processes to create a biosensor technology that is both novel and scalable.
11:50 AM
Long-Term Biocompatibility of a Novel Radiopaque Non-compressible Microsphere for Transarterial Embolization: Kathleen O'Connell1; Daniel Boyd2; Robert Abraham2; Sharon Kehoe1; 1ABK Biomedical Inc.; 2Dalhousie University
Easi-Vue embolic (EV) microspheres are glass-based radiopaque, non-compressible, and non-resorbable microspheres intended for the treatment of arteriovenous malformations and hypervascular tumors. The radiopacity is designed to enable clinicians to directly monitor microsphere deposition, allowing for direct intra-procedural confirmation of implantation. To establish long-term safety and biocompatibility, EV microspheres manufactured by ABK Biomedical were subjected to testing in accordance with ISO 10993. Toxicological risk, which addresses numerous biological endpoints (e.g., genotoxicity), was determined using exhaustive extractable and leachable protocols alongside various analytical techniques to identify and quantify migrated chemical compounds (inorganic and organic). Hemocompatibility, cytotoxicity, sensitization/irritation, and systemic toxicity were established under good laboratory practices (GLP). GLP animal studies (rabbit intramuscular implantation and swine renal artery embolization) confirmed no clinically significant pathological or systemic abnormalities and effective arterial occlusion at 4 and 13-weeks. The biological endpoints required for a long-term implantable device has been satisfied based on ISO 10993 requirements.