Micropatterned surfaces for minimizing percutaneous gastrostomy tube complications

 描述(申请人提供)：使用喂养管的肠内营养为患有神经综合征、癌症、胃肠道疾病、心脏病和代谢性疾病的婴儿和儿童提供了一种长期的改善营养状况的方法，允许通过上腹部直接向胃喂食配方奶。美国医院每年放置超过7万根儿童经皮胃造口术(PG)管。大多数PG管并发症--导致15%的发病率--包括微生物污染、管堵塞、移位和造口并发症。预防PG管并发症需要采用对脆弱的婴儿和儿童群体安全的创新生物材料。这一指令符合美国国立卫生研究院改善人类健康的目标，也符合NICHD的具体目标，即确保所有儿童都有机会充分发挥其健康和富有成效的生活的潜力，不受疾病和残疾的影响。在……里面 为了追求这些重要目标，Sharklet Technologies Inc.建议在儿科PG管上采用生物启发的Sharklet微图案，以显著减少细菌污染、堵塞、移位和造口并发症。这项技术的预期影响是减少PG设备故障，从而总体上改善数千人的婴儿和儿童健康，并将儿科患者的发病率降至最低。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，这对于通常对医疗器械表面化学品更敏感的儿科人群来说很重要。Sharklet的强大之处在于，新的微图案可以在目前使用的相同经过批准的生物医学材料中生产。Sharklet研发团队设想的改进PG设备预计将1)减少导致感染的细菌污染，2)改善喂养配方流以减少堵塞，3)加强造口形成，以限制移位和痛苦的造口部位蜂窝织炎。实现这些改进的可行性将由Sharklet专家跨学科团队通过两个主要的第一阶段SBIR具体目标(涉及使用Sharklet微图案测试设备原型)来实现。目标1将重点是在PG管腔中实施鲨鱼微模式，以减少至少50%的喂养配方积累(p&lt；0.05)和90%的微生物生物膜形成(p&lt；0.05)。目标2将专注于将Sharklet微图案实施到设备外部，以促进至少50%(p&lt；0.05)的体外表皮角质形成细胞迁移和体内25%(p&lt；0.05)的气孔壁形成。Sharklet的关键前期工作是实现这些目标的坚实基础。一旦达到第一阶段SBIR里程碑，后续第二阶段SBIR项目将专注于完成Sharklet微图案化PG器件的开发/商业化。Sharklet Technologies在医疗设备的开发和商业化方面拥有丰富的经验：之前在Foley尿管和气管内管上完成了Sharklet微图案的整合，以防止设备并发症的替代机制。

 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.