A Commercially-Viable MEMS-based Ultrasonic Volume Flow Sensor

描述（由申请人提供）：拟议项目的目标是解决几个技术可行性问题（在I期），然后展示（在随后的II期）一种紧凑的负担得起的设备，用于独立于操作员的血容量流量监测，特别是在终末期肾病（ESRD）患者的血液透析治疗环境中。第一阶段的具体目标是研究使用sononetics的cmos cmos超声换能器技术构建具有可操纵发射波束和数字控制接收孔径的超声阵列的可行性。将开发系统级硬件和软件来控制阵列操作和捕获指示体积流量的多普勒信号。该阵列的第一阶段实验将评估其减少操作员依赖的能力，并在保持紧凑、低轮廓、不干扰透析治疗的同时实现良好的流量传感能力。还将确定使用该阵列获取血管大小和失配角度信息的可行性，以便该阵列可用于满足ESRD设置之外对精确血容量流量测量的更广泛需求。在第二阶段，该阵列以及用于自动控制、信号采集和可能的无线通信的电子设备将集成到一个超紧凑的流量传感贴片中。鉴于仅在美国就有超过33万名ESRD患者，临床市场将从这一创新中受益匪浅。这些患者每周需要三次透析治疗，每年花费美国医疗保健系统超过100亿美元。维持透析治疗的健康血管通道是一个困难而重要的问题，它占透析护理费用的10%以上。定期访问监控已被证明可以显著减少访问失败，并且使用本文提出的设备可能进行频繁的低成本监控，故障率甚至会更低。这将带来广泛的好处，使患者获得更好的治疗效果，减少人员需求，并降低美国医疗保健行业飙升的成本。

DESCRIPTION (provided by applicant): The goal of the proposed program is to address several technical feasibility questions (in Phase I), and then demonstrate (in a subsequent Phase II) a compact affordable device for operator-independent monitoring of blood volume flow, particularly in the setting of hemodialysis treatment for those with end-stage renal disease (ESRD). Phase I specific aims will investigate the feasibility of using Sonetics' CMUT-in-CMOS ultrasound transducer technology to build an ultrasound array with a steerable transmit beam and a digitally-controlled receive aperture. System-level hardware and software will be developed to control the array operation and to capture Doppler signals indicative of volume flow. Phase I experiments with this array will evaluate its ability to reduce operator-dependence and to achieve good flow-sensing ability while maintaining a compact, low profile that will not interfere with dialysis treatment. Feasibility will also be determined for using this array to obtain vessel-size and insonification angle information, such that the array could be employed to meet the broader need for accurate blood volume flow measurements outside of the ESRD setting. In Phase II, the array, together with electronics for automated control, signal acquisition, and possibly wireless communication will be integrated into an ultra-compact flow-sensing patch. The clinical market stands to benefit greatly from this innovation, given that over 330,000 patients suffer from ESRD in the US alone. These patients require dialysis treatment three times per week, which costs the U.S. healthcare system over $10 billion annually. Maintaining healthy vascular access for dialysis treatment is a difficult and important problem, which accounts for over 10% the cost of dialysis care. Regular access monitoring has been shown to significantly reduce access failures, and with the frequent low-cost monitoring that would be possible with the device proposed here, failure rate would be even lower. This would have wide- ranging benefits, enabling better patient outcomes, reducing staffing needs, and reducing the skyrocketing costs in the U.S. healthcare industry. PUBLIC HEALTH RELEVANCE: Potential benefits to public health from the successful development of Sonetics' novel ultrasound-based flow monitor include: reduced health complications for dialysis patients receiving treatment for end-stage renal disease, reduced staffing needs as flow- monitoring devices become less operator dependent, and reduced health-care costs for society as a whole, as dialysis patients place a lower demand on the health-care system. Furthermore, if automated blood flow sensing becomes more widely deployed, health outcomes will improve for additional patient populations such as those with peripheral arterial disease.