Polydimethylsiloxane (PDMS), also known as silastic, is commonly used for medical implants. Despite advantages over earlier elastomers and plastics, PDMS surfaces elicit a significant foreign body response (FBR). This response, triggered by adhesion of non-specific proteins, leads to a thick fibrotic capsule post-implantation, impacting the functionality, safety, and longevity of various medical devices. For neurostimulators such as cochlear implants (CIs), this fibrotic tissue increases the impedance of the nerve - tissue interface and has other deleterious effects, e.g., reduced hearing quality in the case of CIs. Similarly, in stents, catheters, and tubes, the FBR can permanently damage tissue, narrow passageways, and restrict flow rates. A notable example is endotracheal (ET) tubes, which commonly induce subglottic stenosis in long-term intubated patients, leading to life-long complications. Moreover, PDMS-based implanted biomaterials are prone to bacterial biofilm formation, presenting a significant risk for infections. Hospital-acquired infections associated with implanted devices incur ~30 billion dollars annually in healthcare costs in the U.S. alone. To address these challenges, surface modifications to enhance the biocompatibility of PDMS have been a significant focus of research. While impressive antifouling properties have been realized in a variety of coatings-and particularly those based on zwitterionic polymers-these coatings have yet to be incorporated in commercial biomedical devices due to weak grafting to the PDMS surface, inadequate mechanical durability, and complex processing steps that aren't easily transferable to existing manufacturing processes. Our company, ZwiCoat Materials Innovations (ZCMI), has developed the first ever ultra-low-fouling thin film coating that forms a permanent, covalent bond with PDMS surfaces in a simple one-step process. This patented technology combines several properties crucial for commercial viability: strong covalent bonding to PDMS, high lubricity, mechanical durability, and exceptional antifouling capabilities-all achieved through a straightforward, single-step photoinitiated reaction that can be integrated with existing manufacturing protocols. This SBIR project aims to establish the technical merit and feasibility of applying our innovative coating to two existing medical implants, CI electrode arrays and ET tubes-both of which would benefit from greatly reduced fibrosis and are representative of large classes of biomedical devices. The project aims to develop efficient coating technologies, validate coating durability, while confirming their robust antifouling properties on these devices. Phase I success is expected to enable industry partnerships and pave the way for regulatory approval. Concurrently, targeted interviews with hospitals, physicians, patients, and industry leaders will be conducted to inform and refine subsequent Phase II work as well as our commercialization strategy. This approach will position ZCMI to revolutionize the current paradigm wherein fibrosis and moderate infection rates are viewed as inevitable consequences of implanted medical devices, thereby establishing a new standard for patient safety and device efficacy.
Public Health Relevance Statement: Narrative: ZCMI is pioneering the application of zwitterionic thin-film coatings to existing medical implants-e.g., cochlear implants and endotracheal tubes-to greatly reduce scarring and infection rates that are common complications in these devices. Our company's patented one-step process produces a mechanically-robust, ultra-low-fouling coating that permanently bonds to biomaterials. This SBIR project targets the development of scalable coating methods, rigorous testing under practical operating conditions, and comprehensive industry consultations in order to set the stage for a transformative commercial impact on the medical implant industry. Terms: <3T3 Cells; Address; Adhesions; Biocompatible Materials; Biological; Biomaterials; Body Tissues; Cancers; Capsules; Catheters; Cell Adhesion; Cellular Adhesion; Chronic; Cicatrix; Cochlea; Cochlear Implants; Cochlear Organ; Cochlear Prosthesis; Communication Disorders; Communication impairment; Communicative Disorders; Complex; Confocal Microscopy; Consultations; Data; Development; Device Failures; Devices; Dysarthosis; Dysarthria; Effectiveness; Elastomers; Electrical Impedance; Electrodes; Encapsulated; Engineering; Equipment Malfunction; Fibrosis; Filamentous Fungi; Film; Foreign Bodies; Friction; Geometry; Health Care Costs; Health Costs; Healthcare Costs; Hearing; Hearing Loss; Hospital Infections; Hospital acquired infection; Hospitals; Hypoacuses; Hypoacusis; Immunofluorescence Microscopy; Impairment; Impedance; Implant; Implanted Electrodes; In Vitro; Industry; Infection; Inflammation; Inflammatory; Intensive Care; Interview; Intubation; Ir element; Iridium; Laryngeal Granuloma; Lead; Leanness; Legal patent; Length of Life; Light; Longevity; Malignant Neoplasms; Malignant Tumor; Manufacturer; Marketing; Mechanics; Medical; Medical Device; Medulla Spinalis; Methods; Microbial Biofilms; Mission; Modification; Modulus; Molds; Motivation; NIDCD; National Institute on Deafness and Other Communication Disorders; Nerve Tissue; Nervous Tissue; Nosocomial Infections; Operating Rooms; Operative Procedures; Operative Surgical Procedures; Pace Stimulators; Pacemakers; Patents; Pathologic Constriction; Pathological Constriction; Patient outcome; Patient-Centered Outcomes; Patient-Focused Outcomes; Patients; Pb element; Performance; Persons; Phase; Photoradiation; Physicians; Plastics; Platinum; Platinum Black; Polymers; Position; Positioning Attribute; Procedures; Process; Property; Proteins; Protocol; Protocols documentation; Provider; Pt element; Public Health; QOL; Quality of life; Reaction; Research; Resistance; Risk; SBIR; Safety; Scars; Sensory; Serum Proteins; Silastic; Silicones; Small Business Innovation Research; Small Business Innovation Research Grant; Specialist; Spinal Cord; Stenosis; Stents; Sterilization; Surface; Surgeon; Surgical; Surgical Interventions; Surgical Procedure; Survey Instrument; Surveys; Techniques; Technology; Technology Transfer; Testing; Thick; Thickness; Thinness; Tissues; Tracheotomy; Tracheotomy procedure; Tube; Work; biocompatibility; biofilm; biologic; biological material; biomaterial compatibility; biomedical implant; capsule; commercialization; consultation; covalent bond; deep brain stimulator; developmental; dysfunctional hearing; elastomeric; electric impedance; endotracheal; fabrication; hearing challenged; hearing defect; hearing deficient; hearing deficit; hearing difficulty; hearing dysfunction; hearing impairment; heavy metal Pb; heavy metal lead; implant device; implantable device; implantation; improved; industrial partnership; industry partner; industry partnership; indwelling device; infection rate; infection risk; innovate; innovation; innovative; institutional infection; malignancy; manufacture; manufacturing process; mechanic; mechanical; medical implant; meter; neoplasm/cancer; neural; novel; patient oriented outcomes; patient safety; polydimethylsiloxane; polymer; polymeric; prototype; rate of infection; resistant; respiratory; response; success; surgery; tracheomalacia; urinary
