A Commercially-Viable MEMS-based Ultrasonic Volume Flow Sensor

描述(由申请人提供)：拟议计划的目标是(在第一阶段)解决几个技术可行性问题，然后(在随后的第二阶段)展示一种紧凑且负担得起的设备，用于独立于操作员的血流量监测，特别是在终末期肾病(ESRD)患者的血液透析治疗设置中。第一阶段的特定目标将研究使用Sonetics公司的CMUT-in-CMOS超声换能器技术来构建具有可控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，以控制阵列操作并捕获表示流量的多普勒信号。该阵列的第一阶段实验将评估其减少对操作员的依赖和实现良好的流量传感能力的能力，同时保持紧凑、低调，不会干扰透析治疗。还将确定使用该阵列获取血管大小和电离角信息的可行性，以便该阵列可用于满足在ESRD设置之外对准确的血流量测量的更广泛需求。在第二阶段，该阵列将与用于自动控制、信号采集以及可能的无线通信的电子设备一起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33万名患者患有ESRD，临床市场将从这项创新中受益匪浅。这些患者每周需要三次透析治疗，美国医疗系统每年花费超过100亿美元。维持健康的血管通路用于透析治疗是一个困难而重要的问题，占透析护理费用的10%以上。定期的访问监控已被证明可以显著减少访问故障，并且使用这里提出的设备可能实现的频繁的低成本监控，故障率将会更低。这将带来广泛的好处，使患者获得更好的结果，减少人员需求，并降低美国医疗行业飙升的成本。 公共卫生相关性：Sonetics新型超声波流量监测器的成功开发对公共健康的潜在好处包括：减少接受终末期肾脏疾病治疗的透析患者的健康并发症；由于流量监测设备变得不那么依赖操作员而减少人员需求；以及由于透析患者对医疗保健系统的要求较低，从而降低了整个社会的医疗保健成本。此外，如果自动血流检测得到更广泛的部署，将改善更多患者的健康结果，例如那些患有外周动脉疾病的患者。

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.