Ultra Low Profile Coronary Stent Delivery Catheter

描述(由申请人提供)： 在第一阶段中，成功地研制出了一种适用于血管成形术的新型低轮廓“无折叠”球囊。在这项赠款申请中，“无折叠”球囊技术将被应用于创造一种非常低轮廓的球囊导管，它将作为超低轮廓支架输送导管的平台。超低轮廓支架置入导管在介入心脏病学领域具有广泛的临床应用价值，这是因为目前对支架置入扩张冠状动脉的重视。我们将利用这笔第二阶段的赠款，通过物理、生物兼容性和动物测试来设计、建造和表征一种功能齐全的超低轮廓支架输送球囊导管装置。在FDA批准后，该设备将准备好用于商业生产。超低轮廓支架输送球囊导管装置将采用在第一阶段开发的新型“无折叠”球囊。我们将安装一种商用支架，如美敦力“racer”钴铬支架，以测试我们的导管装置。应该注意的是，任何球囊可膨胀支架(包括药物洗脱)都可以安装在我们的导管上。我们将在第二阶段展示我们的超低轮廓支架输送导管将成为一个改进的支架输送和部署平台，因为它的整体交叉轮廓显著降低，硬度降低。我们的目标是与目前的3.0 mm支架输送导管(如美敦力S7支架系统)相比，我们的导管外形减少约33%。使用我们的支架输送导管系统的临床医生将观察到，将支架输送到狭窄病变中变得更加容易，并且无需预扩张就可以直接展开支架的能力增强。直接支架植入术已经在一些临床试验中被证明可以改善临床结果。如果能够实现以下所有目标，一个成功的项目就会完成。1.制造一种含有“无折叠”扩张元件的支架输送导管。2.制作支架输送导管(3毫米)，使其轮廓(包括支架)约为0.030英寸(最大0.032英寸)。3.通过物理测试，证明该装置的爆破强度、膨胀曲线、球囊形状等物理性能适合作为支架置入导管。4.通过生物兼容性研究证明该装置无毒。5.通过动物研究证明，新装置的安全性、可操作性和性能与从目前可用的支架输送导管中选择的对照相当或更好。

DESCRIPTION (provided by applicant): In Phase I a novel low profile "no-fold" balloon suitable for angioplasty applications was successfully developed. In this grant application, the "no-fold" balloon technology will be applied to create a very low profile balloon catheter which will serve as a platform for an ultra low profile stent delivery catheter. An ultra low profile stent delivery catheter has broad clinical applicability in the field of interventional cardiology due to the current emphasis on stenting dilated coronary arteries. We will utilize this phase II grant to design, construct and characterize through physical, biocompatibility and animal testing, a fully functioning ultra low profile stent delivery balloon catheter device. After FDA approval the device will be ready for commercial production. The ultra low profile stent delivery balloon catheter device will incorporate the novel "no-fold" balloon developed in phase I. We will mount a commercially available stent, such as the Medtronic "Racer" cobalt-chromium stent in order to test our catheter device. It should be noted that any ballon expandable stent (including drug-eluting) is mountable on our catheter. We will demonstrate in Phase II that our ultra low profile stent delivery catheter will be an improved stent delivery and deployment platform due to its significantly lower overall crossing profile and decreased stiffness. Our goal is to achieve approximately a 33% reduction in the profile of our catheter when compared to current 3.0 mm stent delivery catheters (such as Medtronic S7 stent system). Clinical practitioners using our stent delivery catheter system will observe an increased ease in delivering a stent to a stenotic lesion and an increased ability to directly deploy the stent without requiring pre-dilation. Direct stenting has been shown in some clinical trials to improve clinical outcome. A successful project will be accomplished if all of the following goals can be realized. 1. Produce a stent delivery catheter incorporating the "no-fold" dilation element. 2. Construct a stent delivery catheter (3 mm), such that it exhibits a profile (including the stent) of about 0.030 in ( max 0.032 inch). 3. Demonstrate through physical testing that the burst strength, expansion curve, balloon shape and other physical properties of the device are suitable for a stent delivery catheter. 4. Show with biocompatibility studies that the device is non- toxic. 5. Demonstrate, with animal studies, that the safety, maneuverability and performance of the new device is equal to or better than a control selected from a currently available stent delivery catheter.