Micropatterned surfaces for minimizing percutaneous gastrostomy tube complications

微图案表面可最大限度地减少经皮胃造口管并发症

• 批准号: 9136437
• 负责人: Ethan E. Mann
• 金额: $ 17.36万
• 依托单位: SHARKLET TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-15 至 2017-04-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9136437
• 关键词: Abdomen; Address; Anatomy; Biocompatible Materials; Biological Assay; Biomedical Engineering; Candida albicans; Caring; Catheters; Cell Culture Techniques; Cellulitis; Chemicals; Chemistry; Child; Child health care; Childhood; Clinical; Clinical Research; Coculture Techniques; Collaborations; Development; Device Designs; Devices; Disease; Ensure; Enteral; Enteral Feeding; Enteral Nutrition; Equipment Malfunction; Exposure to; Family suidae; Feasibility Studies; Foundations; Gastrointestinal Diseases; Gastrostomy; Goals; Healed; Health; Heart Diseases; Hospitals; Human; In Vitro; Indwelling Catheter; Infant; Infant Health; Infection; Lead; Letters; Liquid substance; Malignant Neoplasms; Manufacturer Name; Medical Device; Metabolic; Metabolic Diseases; Microbial Biofilms; Mission; Morbidity - disease rate; National Institute of Child Health and Human Development; Neonatal; Neurologic; Nutritional status; Pain; Pharmaceutical Preparations; Phase; Poison; Population; Pre-Clinical Model; Premature Birth; Prevention; Process; Production; Pseudomonas aeruginosa; Public Health; Research; Silicones; Site; Small Business Innovation Research Grant; Staphylococcus aureus; Stomach; Stomas; Surface; Syndrome; Technology; Testing; Texture; Thick; Tissues; Tube; United States National Institutes of Health; Work; Wound Healing; cell motility; commercialization; cooking; disability; endotracheal; experience; feeding; healing; high risk infant; histopathological examination; implantation; improved; in vivo; innovation; instrument; keratinocyte; meetings; microbial; migration; novel; pediatric patients; preconditioning; prevent; prototype; public health relevance; research and development; response; success; urinary; wound

 DESCRIPTION (provided by applicant): Enteral nutrition using feeding tubes provides a long-term means of improving the nutritional status for infants and children with neurological syndromes, cancer, gastrointestinal disease, cardiac disease, and metabolic disease by allowing administration of feeding formula directly to the stomach through the upper abdomen. More than 70,000 pediatric percutaneous gastrostomy (PG) tubes are placed in US hospitals annually. The majority of PG tube complications-resulting in 15% morbidity-include microbial contamination, tube clogging, dislodgement, and stomal complications. Prevention of PG tube complications requires implementation of innovative biomaterials that are safe for vulnerable infant and child populations. This directive is consistent with the NIH goals of improving human health, as well as the specific NICHD goals of ensuring that all children have the chance to achieve their full potential for healthy and productive lives, free from disease and disability. In pursuit of those important goals, Sharklet Technologies Inc. proposes to incorporate a bio-inspired Sharklet micropattern on pediatric PG tubes to significantly reduce bacterial contamination, clogging, displacement, and stomal complications. The anticipated impact of this technology is to reduce PG device failure, thereby generally improving infant and child health for thousands and minimizing pediatric patient morbidity. The Sharklet micropattern achieves these effects without the use of chemical additives or toxic compounds, which is important for a pediatric population that is typically more sensitive to medical device surface chemicals. The power of Sharklet is that the novel micropattern can be produced in the same approved biomedical materials used currently. The improved PG device envisioned by the Sharklet R&D team is expected to 1) reduce bacterial contamination that causes infections, 2) improve feeding formula flow to reduce clogging, and 3) enhance stoma formation to limit dislodgement and painful stoma site cellulitis. The feasibility of attaining each of these improvements will be pursued by the expert Sharklet interdisciplinary team via two main Phase I SBIR Specific Aims {involving testing device prototypes with the Sharklet micropattern}. Aim 1 will focus on {implementing} the Sharklet micropattern to the PG tube lumen to reduce feeding formula accumulation by at least 50% (p<0.05) and microbial biofilm formation by >90% (p<0.05). Aim 2 will focus on {implementing} the Sharklet micropattern to the device exterior to promote at least 50% (p<0.05) faster in vitro epidermal keratinocyte migration and >25% (p<0.05) thicker stomal wall formation in vivo. Key preliminary work by Sharklet is a strong foundation for achieving these Aims. Once Phase I SBIR milestones are met, a follow-on Phase II SBIR project will be focused on completing development/commercialization of the Sharklet micropatterned PG device. Sharklet Technologies has extensive experience in developing and commercializing medical devices: previous incorporation of the Sharklet micropattern for {alternative mechanisms of preventing device complications} have been accomplished on a Foley urinary catheter and an endotracheal tube.