Heart Functional Assessment Using 2D Strain Rate Imaging

描述（由申请人提供）：尽管目前市场上有应变率成像产品，但没有一种能够提供实时的、区域特异性的、多维度的心肌力学定量测量。基于多普勒应变率成像（SRI）的实现牺牲了图像质量，以提供足够的信噪比应变率图像。此外，基于多普勒的测量精度受到角度依赖的影响。目前其他SRI实现过程存储b模式数据来跟踪图像散斑和其他特征，以消除角度依赖问题；然而，由于这些方法仅使用幅度数据，并且低帧采集率会导致较差的特征跟踪，因此精度有限。Pixel Velocity公司开发了一种技术，克服了这些限制，能够对心脏动力学和力学进行精确的、区域的、定量的测量。在美国国立卫生研究院资助的第一阶段和第二阶段SBIR拨款期间，Pixel Velocity公司与密歇根大学卫生系统、密歇根大学生物医学工程系和WinProbe公司合作，建立了实时二维应变率成像超声的原型，并通过20名患者的人体可行性研究证明了该系统的性能。在第二阶段竞争更新项目Pixel Velocity中，密歇根大学卫生系统和监管事务协会将为实时二维应变速率成像系统寻求FDA的批准。这项工作包括建立必要的质量管理体系，进行一系列临床试验，旨在证明Pixel应变速率成像技术的安全性和有效性，并提交相关的FDA 510(k)申请以获得批准。成功的结果将获得FDA批准上市Pixel Velocity实时二维应变率成像技术，定量测量局部心肌力学功能，为选择和指导心脏治疗提供诊断信息。公共卫生相关性：临床心脏病学的一个主要目标是评估心肌功能。特别是，心肌扩张和收缩的局部评估，或收缩力，提供关键的诊断和治疗信息。Pixel Velocity的实时二维应变率成像系统将为心脏病专家提供快速、准确的手段来量化局部心肌力学功能，使心脏病专家能够改进冠状动脉疾病患者的诊断、治疗和风险分层。

DESCRIPTION (provided by applicant): Although there are strain rate imaging products on the market today, none are able to provide real-time, regionally-specific, quantitative measurements of myocardium mechanics in multiple dimensions. Doppler- based strain rate imaging (SRI) implementations compromise image quality in order to provide adequate signal to noise ratio strain rate images. In addition, accuracy of Doppler-based measurements suffers from angle dependency. Other current SRI implementations process stored B-mode data to track image speckle and other features to eliminate angle dependency issues; however, accuracy is limited since these methods only use amplitude data, and low frame acquisition rates can cause poor feature tracking. Pixel Velocity Inc. has developed a technology which overcomes these limitations and is capable of producing accurate, regional, quantitative measurements of heart dynamics and mechanics. During NIH-funded Phase I and Phase II SBIR grants, Pixel Velocity Inc., in collaboration with The University of Michigan Health System, University of Michigan Biomedical Engineering Department and WinProbe Corporation, built a prototype of the real-time two-dimensional strain rate imaging ultrasound and demonstrated the performance of the system via a 20-patient human feasibility study. During the Phase II Competing Renewal project Pixel Velocity, The University of Michigan Health System and Regulatory Affairs Associates will seek FDA approval for the real-time, two-dimensional strain rate imaging system. This work includes establishing the necessary quality management system, conducting a series of clinical trials designed to demonstrate the safety and efficacy of Pixel's strain rate imaging technology, and submitting the associated FDA 510(k) applications for approval. The successful result will be FDA approval to market the Pixel Velocity real-time, two-dimensional strain rate imaging technology to quantitatively measure regional myocardium mechanical function, providing diagnostic information for selecting and guiding cardiac therapy. PUBLIC HEALTH RELEVANCE: A primary goal of clinical cardiology is assessment of heart muscle function. In particular, regional evaluation of myocardium expansion and contraction, or contractility, provides critical diagnostic and therapeutic information. Pixel Velocity's real-time, two-dimensional strain rate imaging system will offer cardiologists fast and accurate means to quantify regional myocardium mechanical function, enabling cardiologists to improve diagnosis, treatment, and risk stratification of patients with coronary artery disease.