Implantable Pressure/Electrogram Sensor for CHF

CHF 植入式压力/电图传感器

• 批准号: 6406730
• 负责人: PERRY A MILLS
• 金额: $ 12.64万
• 依托单位: TRANSOMA MEDICAL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-21 至 2002-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6406730
• 关键词: biomedical equipment development; blood pressure; congestive heart failure; electrocardiography; heart catheterization; hemodynamics; implant; medical implant science; patient monitoring device; portable biomedical equipment; telemetry

The number of patients suffering from congestive heart failure (CHF) in the U.S. is rapidly increasing, and will soon reach 10 million annually. These patients are typically given multiple drugs and often need frequent dose adjustments that rely upon expensive in-hospital monitoring. As is explained in this proposal, although ambulatory pressure and electrogram monitoring would be ideal for these patients and although direct, left- ventricular (LV) assessment is clearly more beneficial than is indirect right-ventricular monitoring-no method has been developed for accurate, safe, long-term assessment of LV function in ambulatory CHF patients. Phase I will investigate the feasibility of developing a pressure- and electrogram (EGM)-sensing catheter as the enabling component of an implantable, wireless system for long-term monitoring in patients suffering from LV dysfunction and CHF. Data Sciences intends to demonstrate that we can 1) advance our state-of-the-art pressure- measurement technology to meet specifications for human use, 2) fabricate the pressure-transmission catheter (PTO) with materials that are safe and reliable for long-term human use in the left ventricle (LV), and 3) develop a PTC that employs materials proven to be biocompatible and biostable in long-term human use and that will lead to a highly manufacturable design. PROPOSED COMMERCIAL APPLICATIONS: Millions suffer from congestive heart failure (CHF) in the United States and worldwide. The availability of a method to provide long-term hemodynamic outpatient assessment has the potential to optimize patient care, improve quality of life, and reduce costs--significantly advancing the state of the art in CHF management. Developing that capability is the overall goal of this proposed Fast-Track SBIR project. Phase I success will set the stage for the follow-on Phase II R&D, optimization, prototyping and testing needed to pursue FDA approvals and ultimate Phase III commercialization.

在美国，患有充血性心力衰竭（CHF）的患者数量正在迅速增加，很快将达到每年1000万。这些患者通常会接受多种药物治疗，并且经常需要频繁调整剂量，而这依赖于昂贵的院内监测。正如该提案中所解释的，尽管动态压力和电图监测对于这些患者来说是理想的选择，并且尽管直接左心室（LV）评估显然比间接右心室监测更有益，但目前尚未开发出准确、安全、长期评估动态 CHF 患者 LV 功能的方法。第一阶段将研究开发压力和电描记图 (EGM) 传感导管作为可植入无线系统的启用组件的可行性，用于长期监测患有左心室功能障碍和充血性心力衰竭的患者。数据科学旨在证明我们可以：1) 推进最先进的压力测量技术，以满足人类使用的规范；2) 使用可供人类在左心室 (LV) 长期使用安全可靠的材料制造压力传输导管 (PTO)；3) 开发一种 PTC，采用经证明在人类长期使用中具有生物相容性和生物稳定性的材料，从而实现高度可制造的设计。拟议的商业应用：在美国和全世界有数百万人患有充血性心力衰竭（CHF）。提供长期血流动力学门诊评估的方法的可用性有可能优化患者护理、改善生活质量并降低成本，从而显着推进 CHF 管理的最新技术水平。开发这种能力是拟议的 Fast-Track SBIR 项目的总体目标。第一阶段的成功将为后续第二阶段的研发、优化、原型设计和测试奠定基础，以获得 FDA 的批准和最终的第三阶段商业化。