Optical Tomographic Imaging of Peripheral Arterial Disease

描述(申请人提供)：我们建议建立和测试一种动态血管光学断层成像(DVOTI)系统，该系统可用于检测和监测外周动脉疾病(PAD)。据估计，PAD影响了大约800万至1200万人 美国。然而，由于大多数患者没有症状，而且还没有建立单一的可靠的筛查模式，这种疾病被大大低估了。大多数未确诊和未治疗的患者都是糖尿病患者。他们通常患有周围神经病变，因此不会感觉和报告作为疾病早期迹象的症状(如疼痛)。因此，在美国，超过60%(每年约65,000例)的下肢截肢手术是由患有PAD的糖尿病患者进行的。随着糖尿病患者的数量预计将增加两倍，到2050年达到近1亿人，与未诊断PAD相关的问题只会在未来几年内增加。PAD最广泛使用的诊断测试是测定踝臂指数(ABI)，结合脉搏-体积记录(PVR)，已知对糖尿病患者不可靠。即使在非糖尿病患者中，PVR和所有其他现有诊断测试(如双功能超声或磁共振血管成像)的ABI也只能提供有关腿部主要动脉近端闭塞的准确信息。然而，这些测试都没有评估足部远端的血流灌注，大多数并发症，如溃疡和坏疽，通常发生在那里。监测血管成形术或搭桥手术等外科干预措施的成功也存在同样的缺陷，因为医生仅限于同一套测试，而这些测试不足以评估足部的血流灌注。动态Voti有望克服当前诊断和监测技术的局限性，并有可能启动关于如何评估血管疾病的范式转变。在初步研究中，我们已经证明DVOTI可以提供三维时间序列图像，提供关于PAD患者足部血管床的有价值的信息。仪器中使用的近红外光对健康没有不良影响，可以频繁重复测量，以监测介入治疗后的进展。因此，我们相信DVOTI将被证明是诊断和监测非糖尿病和糖尿病患者PAD的一种安全和准确的方法。

DESCRIPTION (provided by applicant): We propose to build and test a dynamic vascular optical tomographic imaging (DVOTI) system that can be used to detect and monitor peripheral arterial disease (PAD). PAD is estimated to affect approximately 8 to 12 million individuals in the United States. However, the disease is considerably under-diagnosed, since most patients are asymptomatic and no single reliable screening modality has been established. Most of the undiagnosed and untreated patients are diabetics. They commonly suffer from peripheral neuropathy and hence do not sense and report symptoms (such as pain) that are early signs of the disease. Consequently more than 60% (~65,000 per year) of all lower extremity amputations in the United States are performed in diabetic patients with PAD. With the number of diabetic patients expected to triple and reach almost 100 million by 2050, the problems related to undiagnosed PAD will only rise in the years to come The most widely used diagnostic test for PAD, determination of the ankle-brachial index (ABI) in conjunction with pulse-volume recordings (PVR), is known to be unreliable for diabetics. And even in non- diabetics, ABI with PVR and all other existing diagnostic tests (such as Duplex Ultrasound or Magnetic resonance angiography), only provides accurate information about proximal occlusions in major arteries of the leg. However, none of these tests assess the distal perfusion of the foot where most complications, such as ulcers and gangrene, typically occur. Monitoring the success of surgical interventions, such as angioplasty or bypass surgery, suffers from the same shortcomings, as physicians are limited to the same suite of tests that are inadequate to assess the perfusion of the foot. Dynamic VOTI promises to overcome the limitations of current diagnostic and monitoring techniques and has the potential to initiate a paradigm shift concerning how vascular diseases are assessed. In preliminary studies we have shown that DVOTI can provide three-dimensional time-series images that provide valuable information about the perfusion of the vascular bed in feet of PAD patients. The near-infrared light used in the instrument has no adverse health effects and measurements can be repeated frequently to monitor post interventional progress. Therefore, we believe that DVOTI will prove to be a safe and accurate method to diagnose and monitor PAD in non-diabetic and diabetic patients.