Intravascular Ultrasound Imaging Guidewire with Wireless Readout

描述（由申请人提供）：美国每年进行超过一百万例经皮冠状动脉介入治疗，如球囊血管成形术和支架置入术，以治疗缺血性心脏病。在几乎所有这些手术中，使用细（0.014”）导丝引导导管插入。我们的目标是为这些导丝增加血管内超声（IVUS）成像能力，以便心脏病专家和介入放射科医生可以在介入之前、期间和之后使用这种有价值的技术作为常规原位成像工具，而无需 延长了手术时间并给患者带来了额外的风险。这种灵活的IVUS探头还可以在现有IVUS探头无法进入的狭窄和迂曲动脉中进行成像。所提出的器械在物理实现方面利用了导丝传感器技术的最新进展，例如压力（FFR）和流量导丝。它使用导丝上提供的交流电源电气连接，以提高安全性，并为无线/宽带数据链路提供低相位噪声时基。它充分利用CMUT-on-CMOS技术进行电子集成，并采用新颖的物理布置，使4个独立的1- D相控阵IVUS芯片提供具有足够分辨率的全截面IVUS图像，而无需任何旋转。它在同一芯片上集成了宽带（200 Mb/s）、超紧凑、短距离、安全和低功耗（150 mW）的无线或有线数据链路，将电缆数量减少到2个，同时保留了导丝的机械性能。具体而言，对于初始演示，我们计划使用40-45 MHz一维CMUT on CMOS阵列，以匹配商用20 MHz、3.5F固态IVUS阵列的横向分辨率。我们将研究基于脉冲无线电超宽带（IR-UWB）和脉冲谐波调制（PHM）的宽带（~ 200 Mb/s）无线概念，以及两个有线硬连线概念，包括通过电力线的RF回遥测和全差分电容读出方法。我们将从这些数据链路替代方案中确定领先的候选方案，以在300 umx 1000 um硅芯片上实现IC，与CMUT IVUS阵列芯片的尺寸相匹配。最后，我们将通过成像实验在PCB上使用双芯片（CMUT和数据链路）配置对导丝上的IVUS概念进行实验验证。拟议的项目可能会导致介入心脏病学的范式转变，为血管和心脏疾病提供新的诊断和治疗能力。它还将为在导丝上结合FFR和IVUS铺平道路，基本上实现三合一工具，这可能以具有成本效益的方式改善手术结局。

DESCRIPTION (provided by applicant): Over a million percutaneous coronary interventions such as balloon angioplasty and stent deployment are performed in the US every year to treat ischemic heart diseases. A thin (0.014") guidewire is used to lead the catheter insertions in nearly all of these procedures. Our aim is to add intravascular ultrasound (IVUS) imaging capability to these guidewires so that cardiologists and interventional radiologists can use this valuable technique as a routine in-situ imaging tool before, during and after interventions without prolonging the procedure time and additional risk to the patient. This flexible IVUS probe will also enable imaging in narrowed and tortuous arteries which cannot be accessed by the existing IVUS probes. The proposed device exploits recent advances in guidewire sensor technology such as pressure (FFR) and flow wires in terms of physical implementation. It uses electrical connections provided on the guidewire for AC power supply for increased safety as well as low phase-noise timebase for wireless/broadband data links. It exploits CMUT-on-CMOS technology to its full extent for electronics integration and in a novel physical arrangement so that 4 separate 1- D phased array IVUS chips provide full cross sectional IVUS images with adequate resolution without any rotation. It integrates broadband (200Mb/s), ultra-compact, short-range, safe and low power (150mW) wireless or over-the-wire data links on the same chip to reduce the cable count down to two, retaining the mechanical performance of the guidewire. Specifically, for initial demonstrations, we plan for 40-45 MHz 1-D CMUT-on- CMOS arrays to match the lateral resolution of commercial 20MHz, 3.5F solid state IVUS arrays. We will investigate a wideband (~200Mb/s) wireless concept based on impulse-radio ultra wideband (IR-UWB) and pulse harmonic modulation (PHM) and two over-the-cable hardwired concepts including RF-back telemetry through power line and fully-differential capacitive readout methods. We will determine the leading candidate from these data link alternatives to implement the IC on a 300umx1000um silicon chip, matching the size of the CMUT IVUS array chips. Finally we will experimentally validate the IVUS on guidewire concept using two-chip (CMUT and Data link) configuration on a PCB through imaging experiments. The proposed project may result in a paradigm shift in interventional cardiology with new diagnostic and therapeutic capabilities for vascular and heart diseases. It will also pave the way for combining FFR and IVUS on a guidewire, essentially implementing 3-in-1 tool, which may improve procedure outcomes in a cost effective manner.