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.

 描述（由申请人提供）：使用饲管的肠内营养通过允许将喂养配方直接给予婴儿和儿童，为患有神经系统综合征、癌症、胃肠道疾病、心脏病和代谢疾病的婴儿和儿童提供了一种改善营养状况的长期方法。美国医院每年放置超过 70,000 根儿科经皮胃造口术 (PG) 管，其中大部分 PG 管出现并发症，占 15%。预防 PG 管并发症需要采用对弱势婴儿和儿童群体安全的创新生物材料，该指令也符合 NIH 改善人类健康的目标。作为 NICHD 的具体目标，确保所有儿童都有机会充分发挥其潜力，过上健康和富有成效的生活，免受疾病和残疾的影响。 为了实现这些重要目标，Sharklet Technologies Inc. 提议在儿科 PG 管上采用仿生 Sharklet 微图案，以显着减少细菌污染、堵塞、移位和造口并发症。该技术的预期影响是减少 PG 装置故障。总体上改善了数千名婴儿和儿童的健康，并最大限度地减少了儿科患者的发病率，从而 Sharklet 微图案在不使用化学添加剂或有毒化合物的情况下实现了这些效果，这对于通常对医疗设备更敏感的儿科人群来说非常重要。 Sharklet 的强大之处在于，Sharklet 研发团队设想的改进的 PG 设备可以使用目前使用的相同批准的生物医学材料来生产，预计将 1) 减少引起感染的细菌污染，2) 改善喂养。配方流量以减少堵塞，3) 增强造口形成以限制移位和疼痛的造口部位蜂窝组织炎 Sharklet 跨学科专家团队将通过两个主要阶段来研究实现这些改进的可行性。 I SBIR 特定目标{涉及带有 Sharklet 微图案的测试设备原型}目标 1 将重点关注在 PG 管腔中{实施} Sharklet 微图案，以减少至少 50% 的喂养配方累积（p<0.05）和微生物生物膜的形成。 >90% (p<0.05) 目标 2 将重点在设备外部{实施} Sharklet 微图案，以至少促进Sharklet 的关键初步工作为实现 I 期 SBIR 里程碑奠定了坚实的基础。后续第二阶段 SBIR 项目将专注于完成 Sharklet 微图案 PG 器件的开发/商业化 Sharklet Technologies 在开发和应用方面拥有丰富的经验。医疗设备商业化：之前已在 Foley 导尿管和气管插管上实现了 Sharklet 微图案的{预防设备并发症的替代机制}的结合。