Development of a Dedicated Fluidjet Technology for Single-session Debridement of Necrotizing Pancreatitis

开发用于坏死性胰腺炎单次清创的专用流体喷射技术

• 批准号: 10699626
• 负责人: Paul Kowalski
• 金额: $ 30万
• 依托单位: HYDROCISION INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699626
• 关键词: Acute; Acute Necrotizing Pancreatitis; Adipose tissue; Adverse event; Affect; Animals; Autopsy; Blood Vessels; Capital Financing; Catheters; Characteristics; Clinical; Complex; Complication; Debridement; Dedications; Development; Devices; Diameter; Effectiveness; Excision; Family suidae; Forcep; Gastroenterologist; Gastroscopes; Goals; Hair; Harvest; Health Care Costs; Histologic; Hospitalization; Infection; Intervention; Knowledge; Label; Length; Length of Stay; Liquid substance; Manuals; Marketing; Massachusetts; Mechanics; Medical Device; Methods; Modeling; Morbidity - disease rate; Multiple Organ Failure; Nature; Necrosis; Operative Surgical Procedures; Orthopedics; Pancreas; Pancreatitis; Pathway interactions; Patients; Phase; Positioning Attribute; Preclinical Testing; Procedures; Prognosis; Protein Structure Initiative; Quality of life; Research Design; Resected; Running; Safety; Saline; Sampling; Sepsis; Site; Small Business Innovation Research Grant; Solid; Specific qualifier value; Specimen; Stents; Sterility; Stomach; Stream; Structure; Suction; System; Systems Analysis; Techniques; Technology; Testing; Therapeutic; Thinness; Time; Tissue Model; Tissues; Training; Treatment Cost; Visit; Water; Work; acute pancreatitis; arm; care delivery; cell injury; commercial application; commercialization; cost; design; experimental study; flexibility; follow-up; gastrointestinal; improved; improved outcome; innovation; instrument; instrumentation; medical specialties; minimally invasive; mortality; necrotic tissue; novel; off-label use; patient population; porcine model; preclinical efficacy; preclinical safety; pressure; prevent; product development; prospective; prototype; success; surgery outcome; technology platform; transmission process; wound care

Acute pancreatitis results in over 275,000 U.S. hospital admissions and more than $2.5 billion in healthcare cost annually. Pancreatic necrosis occurs in about 20% of patients who have severe acute pancreatitis. One in three of these patients will develop infected pancreatic necrosis, which is associated with mortality rates of 11 -39%. Treatment of infected acute necrotizing pancreatitis is crucial to prevent ongoing infection and sepsis-related multiorgan failure. Minimally invasive direct endoscopic techniques have become the preferred method of enabling surgical debridement of pancreatic necrosis. A significant limitation of these procedures is the lack of instruments capable of safely and effectively removing necrotic tissue. Advanced therapeutic endoscopists, trained on stent-enabled access to the pancreas through the stomach wall, are currently using manual instruments and accessories designed for other indications. As a result, removal of necrotic tissue requires multiple instrument passes and an average of 4 separate debridement sessions. The ineffectiveness of off-label instrument use directly contributes to overall procedure-related adverse events of between 21% - 36% and lengthy hospital stays for an already challenged patient population. HydroCision has developed a proprietary method of controlling a hair-thin, supersonic stream of sterile saline while simultaneously enabling an in-line Venturi suction system to cut and remove tissue of various densities from a surgical site in a minimally invasive manner. It has commercialized rigid forms of the technology in the fields of wound care and orthopedics. To meet the unmet need in the gastrointestinal space, the Company is developing G.I.Jet, a dedicated instrument designed to debride necrotic tissue from the pancreas in a single-session without negatively impacting healthy tissue. Adaptation of its technology for direct endoscopic necrosectomy will require the system be made flexible, smaller in diameter, and capable of safely transmitting high-pressure sterile saline over longer operative distances. It will also require adjusting saline-flow rates and instrument configuration parameters such that the system is capable of discernably resecting necrotic pancreatic tissue without disrupting healthy adjacent issue and structures. The long-term goal of the project is to develop an effective dedicated application capable of single-session debridement of pancreatic necrosis, thereby reducing procedure-related complications and associated length of hospital stays among a patient population of high morbidity and mortality. The company will demonstrate feasibility through bench-top studies designed to test a flexible, endoscopically compatible prototype on surrogate tissue models followed by an animal study designed to assess and determine fluidjet velocity, suction forces and instrument configuration required for discernable resection. The Company’s technology platform is uniquely positioned to become the technology of choice for gastroenterologists trained on direct endoscopic methods. There are approximately 27,000 patients per year in the US who will benefit from improved treatment with G.I.Jet at an approximate annual market value of $120 million.

急性胰腺炎导致超过275,000次美国住院和超过25亿美元的医疗保健费用 三分之一 这些患者中，将发展受感染的胰腺坏死，这与死亡率为11-39％有关。 感染急性坏死性胰腺炎的治疗对于防止持续感染和败血症相关至关重要 多器官故障。微创直接内窥镜技术已成为首选方法 实现胰腺坏死的手术调试。这些程序的一个重要限制是缺乏 能够安全有效地去除坏死组织的仪器。先进的治疗性内窥镜药物， 通过Stallch Wall训练了以支架启用胰腺的访问，目前正在使用手册 专为其他指示设计的仪器和配件。结果，去除坏死组织需要 多个仪器通过和平均4个单独的调试会议。标签的无效性 仪器使用直接有助于整体过程相关的不良事件在21％至36％至36％之间 长度医院留给已经挑战的患者人群。 Hydrocision开发了专有的 控制脱发的无菌盐水的超音速流的方法，同时实现串联 Venturi抽吸系统在微创中切割和去除手术部位的各种密度的组织 方式。它在伤口护理和骨科领域具有商业化的刚性形式。到 满足胃肠道空间中未满足的需求，该公司正在开发G.I.Jet，一种专用的仪器 旨在从胰腺上从胰腺上调试坏死组织，而不会对健康产生负面影响 组织。适应其直接内窥镜坏死切除术的技术将需要使系统灵活， 直径较小，并且能够在更长的运行中安全地传输高压无菌盐水 距离。它还需要调整盐水速率和仪器配置参数，以便 系统能够可分辨出坏死胰组织而不会破坏健康的邻近问题 和结构。该项目的长期目标是开发能够有效的专用应用程序 胰腺坏死的一次性偏离，从而减少了与程序有关的并发症和 相关的医院长期停留在高发病率和死亡率的患者人群中。公司将 通过旨在测试灵活的内镜下兼容的台面研究来证明可行性 替代组织模型的原型，然后进行动物研究，旨在评估和确定流体 可辨别切除所需的速度，假设力和仪器配置。公司的 技术平台的独特位置可以成为接受训练的胃肠病学家的首选技术 直接内窥镜方法。美国每年约有27,000名患者将从 G.I.Jet的治疗改进，年利价值约为1.2亿美元。