A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

摘要 仅在美国，就放置了超过300万个外周插入中心静脉导管（PICC 每年提供静脉治疗，其中大约一半的情况下，通过静脉系统的导航是 通常是盲目地或在没有导航引导的情况下执行。PICC放置不当相对常见， 昂贵，并且对危重患者有严重的并发症。不幸的是，在盲目安置30-55%的 PICC尖端在第一次尝试时没有最佳放置，需要重新定位，这具有平均直接 每名患者的费用为223美元，并且通常需要移除和重新插入携带有 4-6%的气胸风险。此外，大约17%的这些位置不正确的PICC被放置在 进入右心房，这与许多危及生命的并发症有关。放置不当 的PICC也经常需要转诊到介入放射科医生进行透视引导的中心线 放置，这是昂贵的（1,000美元），并需要更多的辐射暴露的病人。毫不奇怪的是， 超过一半的PICC给药于60岁以上的患者。因此，安全准确的PICC 安置对于为美国老年人提供高质量的护理至关重要。尽管有严重不良事件 与PICC管线的盲目放置相关，目前的血管通路系统尚未被广泛采用。 Teleflex ARROW® G4 VPS和Bard Sherlock 3CG® TCS是PICC引导系统， 用于将PICC尖端定位到正确位置的ECG：包括下上级腔静脉的区域 (SVC)和腔房连接（CAJ）。虽然这些程序通常限制了确认X光的需要，但它们 成功安置率低且可变（44-84%），比标准高30-70% PICC需要熟练的工作人员，并且与标准盲法PICC相比，手术时间明显更长 安置另外，这些引导系统仅依赖于ECG的使用，这对患者是无效的 心律失常，这种情况影响了大约16%的需要PICC导管的患者。到 为了满足准确、安全和具有成本效益的PICC放置需求，Piccolo Medical开发了 Smart PICC™系统是一种床旁导管系统，使用不同的血流动力学特征， 血管区域结合ECG，用于实时血管通路引导进入SVC/CAJ。目标 商业化准备试点（CRP）的目的是支持具有成本竞争力的 血管通路市场中的Smart PICC™系统。首先，我们将设计第二代智能PICC™ 系统具有改进的可用性和性能，以及降低的商品销售成本（COGS）， 商业发射（目标1）。其次，我们将向FDA提交Smart PICC™ Gen 2系统的510（k） (Aim 2）。这些目标的成功完成将使我们能够在约2.5%的时间内将这种精制系统商业化。 多年来，这项提案的资金。

Abstract In the United States alone, more than three million peripherally inserted central catheters (PICCs) are placed each year to provide IV therapies, where in about half of cases navigation through the venous system is typically performed blind, or without navigation guidance. Improper PICC placement is relatively common, is costly, and has serious complications for critically-ill patients. Unfortunately, under blind placement 30-55% of PICC tips are not optimally placed on the first attempt and require repositioning, which has an average direct cost of $223 per patient and often necessitates the removal and reinsertion of the catheter line that carries a 4-6% risk of pneumothorax. Moreover, approximately 17% of these improperly positioned PICCs are placed into the right atrium, which is associated with a multitude of life-threatening complications. Improper placement of PICCs also often requires referral to an interventional radiologist for fluoroscopic-guided central line placement, which is expensive ($1,000) and requires more radiation exposure for the patient. Not surprisingly, over half of all PICCs are administered to patients over the age of 60. Therefore, safe and accurate PICC placement is critical for providing high-quality care to older Americans. Despite serious adverse events associated with blind placement of PICC lines, current vascular access systems have not been widely adopted. The Teleflex ARROW® G4 VPS and the Bard Sherlock 3CG® TCS are PICC guidance systems that employ ECG for positioning the PICC tip into the correct location: the region that includes the lower superior vena cava (SVC) and cavoatrial junction (CAJ). While these procedures often limit the need for a confirmatory X-ray, they have poor and variable successful placement rates (44-84%), are 30-70% more expensive than standard PICCs, require skilled staff, and have significantly longer procedure times as compared to standard, blind PICC placement. Additionally, these guidance systems rely solely on the use of ECG, which is ineffective for patients with cardiac arrhythmias, a condition that affects approximately 16% of all patients requiring a PICC line. To address the need for accurate, safe, and cost-effective PICC placement, Piccolo Medical has developed the Smart PICC™ system, a point-of-care catheter system that uses unique hemodynamic signatures of different vascular regions in combination with ECG for real-time vascular access guidance into the SVC/CAJ. The goal of this Commercialization Readiness Pilot (CRP) is to support the commercialization of a cost competitive Smart PICC™ system in the vascular access marketplace. First, we will design a Gen 2 Smart PICC™ system with improved usability and performance, and reduced cost of goods sold (COGS) to enable commercial launch (Aim 1). Second, we will submit a 510(k) to the FDA for the Smart PICC™ Gen 2 system (Aim 2). The successful completion of these Aims will allow us to commercialize this refined system within ~2.5 years of the funding of this proposal.