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

基本信息

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
项目类别：
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

项目摘要

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.

急性胰腺炎导致美国超过 275,000 人入院治疗，医疗费用超过 25 亿美元每年约有 20% 的重症急性胰腺炎患者发生胰腺坏死。的这些患者将出现感染性胰腺坏死，死亡率为 11 -39%。治疗感染的急性坏死性胰腺炎对于预防持续感染和败血症相关的疾病至关重要微创直接内镜技术已成为治疗多器官衰竭的首选方法。这些手术的一个显着限制是缺乏胰腺坏死的手术清创。能够安全有效地去除坏死组织的先进治疗内窥镜仪器，接受过通过胃壁通过支架进入胰腺的培训，目前正在使用手动专为其他适应症设计的器械和配件因此需要去除坏死组织。多次器械通过和平均 4 次单独的清创疗程标签外的无效性。仪器使用直接导致总体手术相关不良事件发生率在 21% - 36% 之间 HydroCision 为已经面临长期住院困扰的患者群体开发了一种专有技术。一种控制细如发丝的超音速无菌盐水流的方法，同时实现在线文丘里抽吸系统，用于以微创方式从手术部位切割和去除各种密度的组织它已将伤口护理和骨科领域的严格技术商业化。为了满足胃肠道领域未满足的需求，公司正在开发 G.I.Jet，一种专用仪器旨在一次清除胰腺坏死组织，而不会对健康产生负面影响其技术用于直接内窥镜坏死切除术将需要该系统变得灵活、直径更小，能够在更长的操作时间内安全地传输高压无菌盐水它还需要调整盐水流速和仪器配置参数，以便系统能够明显切除坏死的胰腺组织，而不破坏健康的邻近组织该项目的长期目标是开发一个有效的专用应用程序，能够单次清创胰腺坏死，从而减少手术相关并发症该公司将减少高发病率和死亡率的患者群体的相关住院时间。通过旨在测试灵活的、内窥镜兼容的台式研究来证明可行性在替代组织模型上制作原型，然后进行旨在评估和确定流体喷射的动物研究可辨别切除所需的速度、吸力和仪器配置。技术平台具有独特的定位，可以成为训练有素的胃肠病学家的首选技术美国每年约有 27,000 名患者将从直接内窥镜检查中受益。通过 G.I.Jet 改善治疗，年市场价值约为 1.2 亿美元。