Tissue Oxygen Monitoring in Peripheral Vascular Disease

周围血管疾病中的组织氧监测

基本信息

批准号：
9752322
负责人：
Michael S Conte
金额：
$ 85.94万
依托单位：
PROFUSA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9752322
关键词：
Acute Adopted Affect Aftercare Age American Amputation Angioplasty Appearance Area Arteries Atherectomy Atherosclerosis Balloon Angioplasty Blood Vessels Blood flow Businesses Bypass Chronic Clinical Clinical Research Collaborations Consumption Coronary Arteriosclerosis Cutaneous Data Decision Making Detection Disease Progression Economic Burden Ensure Europe Exercise Family suidae Fluorescence Fluoroscopy Gangrene Goals Histology Human Human Resources Hydrogels Injectable Injections Intermittent Claudication Intervention Ischemia Lead Limb Salvage Limb structure Location Measurement Measures Medical Methodology Methods Modeling Monitor Noise North America Operative Surgical Procedures Optical Readers Organ Outcome Oxygen Pain Patients Performance Perfusion Peripheral Peripheral Vascular Diseases Peripheral arterial disease Phase Physicians Predictive Value Prevalence Procedures Quality of life Rattus Reaction Time Reperfusion Therapy Reporting Rest Safety Signal Transduction Skin Small Business Innovation Research Grant Standardization Stents Stream Surgeon Symptoms Technology Testing Therapeutic Time Tissues Toes Toxic effect Ulcer Validation Wireless Technology arm base biomaterial compatibility clinical practice commercialization cost cytotoxicity design experience foot healing hemodynamics improved indexing instrumentation limb amputation meetings mortality novel open label pre-clinical pressure product development public health relevance residence restenosis revascularization surgery safety and feasibility sensor sensor technology subcutaneous success

项目摘要

DESCRIPTION (provided by applicant): The goal of this Fast Track SBIR is to demonstrate the functionality of PROFUSA's novel injectable tissue oxygen monitors in patients with peripheral arterial disease (PAD) and to determine the its ability to detect restenosis in critical limb ischemia (CLI). PAD is a manifestation of systemic atherosclerosis that affects 10-12 million people in the U.S., with prevalence increasing with age. PAD ranges from mild (accompanied by intermittent claudication or pain with exercise) to severe (accompanied by CLI and gangrene), and is associated with high rates of amputation, mortality and poor quality of life. With the appropriate monitoring and treatment, disease progression can be halted and even reversed, but easy-to-use, accurate monitoring products to indicate when a change in therapy is needed do not exist. PROFUSA's oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real-time tissue oxygen levels in the ischemic limb before, during, and after treatment, thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear. In this Fast Track SBIR, we propose 1) to confirm biocompatibility according to ISO 10993 standards, 2) to enhance user experience for commercialization by minimizing sensor size and 3) to clinically verify the ability of PROFUSA's tissue oxygen sensors to detect restenosis in PAD/CLI patients. In addition to the strong scientific and pre-clinical teams, medical, clinical, regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development. These data will be crucial in advancing PROFUSA towards commercialization and regulatory approvals.

描述（由申请人提供）：本快速通道 SBIR 的目标是展示 PROFUSA 新型可注射组织氧监测仪在外周动脉疾病 (PAD) 患者中的功能，并确定其在危重患者中检测再狭窄的能力。肢体缺血 (CLI) 是全身性动脉粥样硬化的一种表现，在美国影响着 10-1200 万人，其患病率随着年龄的增长而增加，从轻度（伴有间歇性跛行或运动疼痛）到重度（伴有 CLI）。坏疽），并与高截肢率、死亡率和生活质量差有关。通过适当的监测和治疗，可以阻止甚至逆转疾病的进展，但 PROFUSA 的氧传感技术尚不存在易于使用、准确的监测产品来指示何时需要改变治疗，可以帮助挽救截肢的肢体。提供一种在治疗前、治疗期间和治疗后测量缺血肢体的实时组织氧水平的方法，从而能够在出现晚期症状之前及时进行适当的治疗。在此快速通道 SBIR 中，我们建议 1)除了强大的科学性和预先性之外，还根据 ISO 10993 标准确认生物相容性，2) 通过最小化传感器尺寸来增强商业化的用户体验，3) 临床验证 PROFUSA 的组织氧传感器检测 PAD/CLI 患者再狭窄的能力。 -临床团队、医疗、临床、监管和业务人员将成为该项目不可或缺的一部分，为成功的产品开发提供早期策略，这些数据对于推动 PROFUSA 走向商业化和监管批准至关重要。