Coronary Post-Dilatation Catheter

描述(由申请人提供)：冠状动脉疾病(CAD)是一种全国性和世界性的流行病，在任何疾病情况下都会给医疗保健系统带来最大的临床和经济负担。稳定和急性冠状动脉疾病的患者通常接受经皮冠状动脉介入治疗(PCI)，包括支架置入术。高达85%的冠状动脉支架部署不足导致更高的靶血管重建率(TVR)、支架内再狭窄、支架内血栓形成，从而导致更高的死亡率。部署不足与几个因素有关，包括制造商体外与体内压力/直径顺应性关系不准确，因此需要进一步扩张，通常使用更硬、不顺应性的球囊。然而，扩张后的球囊仍然不能提供足够的扩张，因为与支架部署球囊类似，它们也依赖于体外顺应性图表来确定体内的大小。因此，需要一种工具来在球囊充气期间向临床医生实时提供准确的球囊尺寸信息。开发了一种新型的电导球囊(CB)导管系统，其功能类似于典型的扩张后导管，但具有额外的功能，可以准确测量和显示实时球囊尺寸。CB导管利用一个简单的物理定律(欧姆定律)来确定球囊横截面积(CSA)/直径，在充气过程中通过测量装置内部的电压来确定。尺寸结果实时显示在简单的床边控制台显示器上，以帮助医生在球囊扩张期间(即，类似于当前显示充气期间压力的显示器)。CB导管系统在实验台上和在健康猪体内的初步结果显示，良好的准确性(直径误差1.4%)、可重复性(直径误差1.1%)和安全性。然而，在转化到临床(未来的第二阶段应用)之前，还需要额外的工作来更新控制台和导管，并在动脉粥样硬化猪身上进一步验证该系统(这是第一阶段的应用)。因此，在这一阶段的应用中，我们建议建立一种临床上可用的CB导管系统，并在动脉粥样硬化猪身上进行体内验证。基于这项技术的坚实物理基础、出色的初步结果以及之前已知的相关系统的安全性，CB导管系统有望在任何类型的病变血管条件下提供高精度和可重复的整个冠状动脉支架范围内的球囊尺寸的实时数字显示，几乎不需要医生培训。在第一阶段项目完成后，我们期待着将CB导管系统快速和合理地转换为MAN的第二阶段项目。该项目有能力影响患有多种合并症的患者，并覆盖包括NIDDK、NHLBI和NINDS在内的各种NIH研究所和中心。

DESCRIPTION (provided by applicant): Coronary artery disease (CAD) is a national and worldwide epidemic that places the largest clinical and economic burden on the healthcare system of any disease condition. Patients with stable and acute coronary conditions are often treated with percutaneous coronary intervention (PCI), including stenting. Up to 85% of all coronary stents are under-deployed leading to higher target revascularization rates (TVR), in-stent restenosis, in-stent thrombosis, and therefore, higher mortality. Under-deployment is related to several factors, including inaccurate manufacturer ex vivo versus in vivo pressure/diameter compliance relationships, and thus requires further post-dilatation typically with a stiffer, non-compliant balloon. However, post-dilatation balloons still fail to provide adequate expansion because, similar to the stent deployment balloons, they also rely on ex vivo compliance charts to determine in vivo size. Consequently, a tool is needed to provide accurate balloon sizing information to the clinician in real-time during balloon inflation. A novel conductance balloon (CB) catheter system has been developed that functions as a typical post-dilatation catheter, but with additional functionality for accurate measurement and display of real-time balloon size. The CB catheter utilizes a simple physical law (Ohm's Law) to determine the balloon cross-sectional area (CSA)/diameter through electrical voltage measurements made inside the device during inflation. The sizing results are displayed in-real time on a simple bed-side console display to aid the physician during balloon expansion (i.e., similar to current displays that show pressure during inflation). Preliminary results with the CB catheter system on the bench and in vivo in healthy swine showed excellent accuracy (1.4% diameter error), repeatability (1.1% diameter error), and safety. However, additional work is needed to update the console and catheter and further validate the system in atherosclerotic swine (this Phase I application) before translation to the clinic (future Phase II application). Therefore, in this Phae I application, we propose the creation of a clinically-ready CB catheter system and its validation in vivo in atherosclerotic swine. Based on the strong physics foundation of the technology, the excellent preliminary results, and the previously known safety of a related system, the CB catheter system is expected to provide highly accurate and repeatable real-time digital display of balloon size across the entire coronary stent range in any type of diseased vessel condition with virtually no physician training required. After the completion of this Phase I project, we expect a quick and logical translation of the CB catheter system to a Phase II project in man. This project has the ability to impact patients with multiple comorbidities and reach across various NIH Institutes and Centers including the NIDDK, NHLBI, and NINDS.