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例美国住院和超过25亿美元的医疗保健费用 每年。胰腺坏死发生在约20%的重症急性胰腺炎患者中。三分之一 这些患者中的50%将发展为感染性胰腺坏死，其与11 - 39%的死亡率相关。 感染性急性坏死性胰腺炎的治疗对于预防持续性感染和脓毒症相关的 多器官衰竭微创直接内镜技术已成为首选的方法， 使得能够对胰腺坏死进行外科清创。这些程序的一个重大局限性是缺乏 能够安全有效地去除坏死组织的器械。先进的治疗内窥镜， 接受过通过胃壁进入胰腺的支架启用入路培训，目前正在使用手动 设计用于其他适应症的工具和附件。因此，去除坏死组织需要 多次器械通过和平均4次单独的清创术。标签外使用的无效性 手术工具使用直接导致21% - 36%的总体手术相关不良事件， 对于已经受到挑战的患者群体来说，住院时间过长。HydroCision开发了一种专有的 一种控制头发丝般细的无菌盐水超声流的方法， 文丘里抽吸系统，以微创方式从手术部位切割和移除各种密度的组织 方式它在伤口护理和整形外科领域将该技术的严格形式商业化。到 为了满足胃肠道空间未满足的需求，公司正在开发G.I.Jet，一种专用仪器， 设计用于在单次治疗中清除胰腺坏死组织，而不会对健康 组织.将其技术用于直接内窥镜坏死切除术将要求该系统具有灵活性， 直径更小，能够在更长的手术时间内安全传输高压无菌盐水 的距离.还需要调整盐水流速和仪器配置参数， 系统能够可辨别地切除坏死胰腺组织而不破坏健康的邻近组织 和结构。该项目的长期目标是开发一个有效的专用应用程序， 胰腺坏死的单次清创，从而减少手术相关并发症， 高发病率和高死亡率患者人群的相关住院时间。公司将 通过实验室研究证明可行性，实验室研究旨在测试一种灵活的内窥镜兼容 替代组织模型上的原型，随后进行动物研究，旨在评估和确定fluidjet 速度、抽吸力和可辨别切除所需的器械配置。公司 该技术平台具有独特的优势，可成为接受过以下培训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名患者将受益于 改善G.I.Jet的治疗，年市场价值约为1.2亿美元。