Micropatterned surfaces for minimizing pediatric gastrostomy tube complications

微图案表面可最大程度地减少儿科胃造口管并发症

• 批准号: 9348125
• 负责人: Ethan E. Mann
• 金额: $ 78.68万
• 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 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9348125
• 关键词: Abdomen; Address; Adherence; Anti-Infective Agents; Area; Bacterial Attachment Site; Biocompatible Materials; Biomedical Engineering; Businesses; Caring; Chemicals; Chemistry; Child; Childhood; Clinical Research; Clinical Trials; Collaborations; Development; Device Designs; Devices; Dimensions; Disease; Ensure; Enteral; Enteral Feeding; Enteral Nutrition; Epithelial Cells; Equipment Malfunction; Extravasation; Family suidae; Funding; Gastrostomy; Generations; Goals; Hospitals; Human; In Vitro; Infection; Investments; Lead; Legal patent; Letters; Liquid substance; Manufacturer Name; Medical; Medical Device; Methods; Microbial Biofilms; Mission; Modeling; Morbidity - disease rate; National Institute of Child Health and Human Development; Neonatal; Nutritional status; Oral; Pathway interactions; Patients; Performance; Phase; Phase II Clinical Trials; Poison; Population; Prevention; Process; Public Health; Regulation; Research; Research Methodology; Risk; Safety; Shark; Silicones; Skin; Small Business Innovation Research Grant; Stomach; Stomas; Surface; System; Technology; Testing; Thick; Trauma; Traumatic injury; Tube; Validation; Work; Wound Healing; adult nutrition; base; cell motility; commercialization; cooking; cost; design; disability; economic cost; expectation; experience; feeding; healing; high risk infant; implantation; improved; in vitro testing; industry partner; innovation; instrument; interest; lot production; microbial; multidisciplinary; novel; nutrition; pediatric patients; performance tests; phase 1 study; post-market; pre-clinical; prevent; product development; response; safety testing; scale up; skills; success; verification and validation

Summary In a variety of diseases and conditions when oral feeding is impossible, enteral feeding through percutaneous gastrostomy (PG) is necessary to provide long-term nutrition for adult and pediatric patients. It is estimated that over 70 thousand feeding tubes are placed in pediatric patients in the US annually. However, these patients frequently experience complications associated with PG tube placement. Late-onset complications (at least 6 days after PG insertion) were estimated to be 44% in pediatric patients. Common complications include infections, tube clogging, tube dislodgement and poor stoma formation. Poor stoma formation, in particular, leads to a variety of problems such as peristomal infection and gastric content leakage. PG-associated complications often require hospital revisions, resulting in higher economic cost as well as increased patient morbidity and discomfort. Revisions are estimated to cost over $1 million annually in pediatric PG patients in the US alone. Therefore, effective strategies are required to prevent these complications, without introducing more issues, in children whose nutrition is dependent on PG feeding. Here, Sharklet Technologies, Inc. proposes to develop a novel Sharklet-micropatterned pediatric PG device that is anti- infective, anti-clogging and improves stoma formation in children who receive enteral feeding. The power of the Sharklet technology is that the novel micropattern can be produced in the same approved biomedical materials used currently, without the addition of any potentially toxic chemical. It therefore offers a safe solution for vulnerable infant and child populations, consistent with 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. Sharklet Technologies, Inc. (STI) applies proprietary micrometer-scale topography onto a variety of medical and consumer devices in order to control bioadhesion. Design of the Sharklet micropattern is inspired by the microtopography on shark skin that has a natural anti-fouling activity. STI has received Phase I SBIR funding to test the feasibility of Sharklet pediatric PG tubes and majority of milestones have been achieved. Sharklet surfaces have been shown to reduce at least 50% feeding formula accumulation and prevent microbial biofilms by 89%. In addition, Sharklet micropattern promotes human epithelial cell migration towards wounded areas by 167%. Building on these successes, in this Phase II project, STI proposes to verify the efficacy of Sharklet PG devices in reducing complications, and to manufacture and commercialize this novel device for pediatric patients. Phase II Aims are proposed to scale up Sharklet PG development: Aim 1 –Develop manufacturing for a silicone PG tube using design controls and product development to produce a first-generation product; Aim 2 –Examine first- generation PG tubes for performance against in vitro tests of anti-clogging, bacterial contamination prevention, and cell migration improvement; Aim 3 –Test the PG tube for use in a preclinical porcine model of feeding tube implantation to demonstrate improved stoma formation in the presence of bacterial contamination or trauma; Aim 4 – Manufacture a final production lot of PG tubes for validation and verification testing such that requirements are met for 510k submission with the claim equivalence compared to a predicate device. Phase II results will lead to the submission of a 510(k) regulatory package for a device-level claim. The strong Phase I success and the broad-based technical, business and regulatory skills of STI’s expert, multi- disciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post-Phase II clinical trials in collaboration with a third-party investor or industry partner. In all, the proposed Phase II project will validate the efficacy of this innovative PG product that harbors multiple patented Sharklet micropatterns to minimize PG-associated complications in pediatric populations.

总结 在各种疾病和条件下，当口服喂养是不可能的，肠道喂养通过 经皮胃造口术（PG）是为成人提供长期营养的必要手段， 儿科患者。据估计，超过7万喂养管被放置在儿科 美国患者每年然而，这些患者经常出现并发症， 与PG管放置相关。迟发性并发症（PG后至少6天 在儿科患者中估计为44%。常见并发症包括 感染、管堵塞、管移位和气孔形成不良。气孔形成不良， 特别是导致各种问题，例如造口周围感染和胃内容物 泄漏PG相关并发症通常需要医院翻修，导致更高的 经济成本以及增加的患者发病率和不适。修订估计将 仅在美国，儿科PG患者每年花费超过100万美元。因此，有效 需要制定战略来预防这些并发症，而不引入更多问题， 营养依赖于PG喂养的儿童。在这里，鲨鱼科技公司。 建议开发一种新的Sharklet微图案儿科PG设备， 在接受肠内营养的儿童中， 喂食Sharklet技术的强大之处在于， 在目前使用的相同批准的生物医学材料中，不添加任何潜在的 有毒化学物质因此，它为脆弱的婴儿和儿童群体提供了一个安全的解决方案， 符合NICHD的目标，即确保所有儿童都有机会充分实现其 健康和有生产力的生活的潜力，没有疾病和残疾。 Sharklet Technologies，Inc. (STI)将专有的微米级形貌应用于 各种医疗和消费设备，以控制生物粘附。小鲨鱼的设计 微图案的灵感来自鲨鱼皮肤上的微地形，具有天然的防污功能 活动STI已获得第一阶段SBIR资金，以测试Sharklet儿科PG的可行性 管道和大部分里程碑已经实现。小鲨鱼表面已被证明 减少至少50%的喂养配方奶粉积累，并防止89%的微生物生物膜。在 此外，Sharklet微图案促进人类上皮细胞向伤口迁移 面积167%。在这些成功的基础上，在第二阶段项目中，科技和创新建议核实 Sharklet PG器械在减少并发症方面的有效性，以及制造和 将这一新型装置商业化用于儿科患者。第二阶段的拟议目标是 Sharklet PG开发：目标1 -使用设计开发硅胶PG管的制造 控制和产品开发，以生产第一代产品;目标2 -首先检查- 第二代PG管，用于抗堵塞、细菌和微生物的体外试验 污染预防和细胞迁移改善;目的3 -测试PG管用于 用于证明改进的造口形成的饲管植入的临床前猪模型 在存在细菌污染或创伤的情况下;目标4 -生产最终生产批次 用于确认和验证试验的PG管，以满足510 k的要求 与同品种器械相比具有等同性声明的提交。第二阶段的结果将导致 提交器械级声明的510（k）监管包。强大的第一阶段 成功和广泛的技术，业务和监管技能的STI的专家，多， 专业团队为成功的第二阶段制造和验证项目奠定了基础 旨在与第三方投资者合作进行II期后临床试验，或 行业合作伙伴。总之，拟议的第二阶段项目将验证这一创新的 PG产品，包含多个专利Sharklet微图案，以最大限度地减少PG相关 儿科人群的并发症。