Ultra Low Profile Coronary Stent Delivery Catheter

超薄型冠状动脉支架输送导管

• 批准号: 7012198
• 负责人: Alan M Zamore
• 金额: $ 81.9万
• 依托单位: ZYLON CORPORATION
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7012198
• 关键词: bioengineering /biomedical engineering; biomaterial compatibility; biomedical equipment development; catheterization; heart catheterization; intraluminal angioplasty; polymers; swine

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.

描述（由申请人提供）： 在第一阶段，成功开发了一种适用于血管成形术应用的新型低剖面“无折叠”球囊。在该授权申请中，“无折叠”球囊技术将用于创建非常低剖面的球囊导管，该球囊导管将用作超低剖面支架输送导管的平台。由于目前对扩张冠状动脉支架植入的重视，超低轮廓支架输送导管在介入心脏病学领域具有广泛的临床适用性。我们将利用这一II期资助，通过物理、生物相容性和动物试验设计、构建和表征功能齐全的超低切迹支架输送球囊导管器械。在FDA批准后，该设备将准备用于商业生产。超低切迹支架输送球囊导管器械将结合I期开发的新型“无折叠”球囊。我们将安装市售支架，例如Medtronic“Racer”钴铬合金支架，以测试我们的导管器械。应该注意的是，任何球囊扩张支架（包括药物洗脱支架）都可以安装在我们的导管上。我们将在第II阶段证明，我们的超低外径支架输送导管将是一种改进的支架输送和展开平台，因为其总体通过外径显著降低，刚度降低。我们的目标是，与当前的3.0 mm支架输送导管（例如Medtronic S7支架系统）相比，我们的导管外径减小约33%。使用我们的支架输送导管系统的临床从业者将观察到将支架输送到狭窄病变的难度增加，并且直接展开支架而无需预扩张的能力增加。在一些临床试验中，直接支架植入术已被证明可改善临床结局。一个成功的项目将完成，如果所有以下目标可以实现。1.生产包含“无折叠”扩张元件的支架输送导管。2.构建支架输送导管（3 mm），使其外径（包括支架）约为0.030 in（最大0.032 in）。3.通过物理试验证明器械的爆破强度、扩张曲线、球囊形状等物理性能适合支架输送导管。4.通过生物相容性研究证明该器械无毒。5.通过动物研究证明，新器械的安全性、可操作性和性能等于或优于从当前可用支架输送导管中选择的对照品。