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

摘要 仅在美国，就有300多万根经外周插入的中心静脉导管(PIC) 每年提供静脉治疗，在大约一半的情况下，通过静脉系统导航是 通常是盲目执行的，或者没有导航指导。PICC放置不当是比较常见的，是 价格昂贵，对危重患者来说有严重的并发症。不幸的是，在盲目安置下，30%-55%的 PICC提示在第一次尝试时不会放置在最佳位置，需要重新定位，这具有平均直接 每名患者的费用为223美元，通常需要移除并重新插入携带有 发生气胸的风险为4-6%。此外，这些放置不当的PIC中约有17%被放置 进入右心房，这与一系列危及生命的并发症有关。放置不当 PICC的发生通常还需要转诊至介入放射科医生，以进行透视引导的中心线 安置，这是昂贵的(1,000美元)，并需要患者更多的辐射暴露。不足为奇的是， 超过一半的PICC是给60岁以上的患者使用的。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。尽管发生了严重的不良事件 与PICC管路盲法放置相关的是，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，采用 用于将PICC尖端定位到正确位置的心电图：包括下腔静脉的区域 下腔静脉(SVC)和腔静脉交界处(CAJ)。虽然这些程序通常限制了对确诊X光的需求，但它们 就业率低且不稳定(44%-84%)，比标准价格高出30%-70% PICC需要熟练的工作人员，与标准的盲人PICC相比，操作时间明显更长 放置。此外，这些引导系统完全依赖于心电图的使用，这对患者来说是无效的 对于心律失常，这种情况影响到大约16%需要PICC管路的患者。至 为了满足对准确、安全和经济的PICC置入的需求，Piccolo Medical开发了 Smart PICC™系统，这是一种护理点式导管系统，使用不同类型的 血管区域与心电图相结合，实时引导血管进入SVC/CAJ。目标是 此商业化准备试点(CRP)的目的是支持具有成本竞争力的商业化 智能人保™系统在血管接入市场的应用。首先，我们将设计一款第二代智能人保™ 系统具有更高的可用性和性能，并降低了销售成本(COGS)，以实现 商业发射(AIM 1)。其次，我们将向食品和药物管理局提交智能人保™第二代系统的510(K) (目标2)。这些目标的成功实现将使我们能够在~2.5年内将这一改进的系统商业化 多年来为这项提案提供的资金。

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.