SHAPE-MEMORY THERMOPLASTIC CATHETER/INSERTION SHEATH

描述：(改编自调查人员摘要)这项研究将 确定生产组合Seldinger的可行性 可软化形状记忆热塑性塑料的导管/插入护套 (SMT)。这种装置将简化静脉和动脉的插入 一次穿刺术、扩张术和皮下置管 设备。SMT将被复合和造粒，然后挤压成 高模数，薄壁，不透射线管，将后成型为 末端大约有16个口径。导管的剩余部分 车身应为法语8或更大。在达到37摄氏度时，逐渐变细 尖端将扩展到鞘的近端的较大直径， 以允许使用可选的导丝插入导管。在.期间 扩大后，SMT将经历刚度降低，这应该会有所帮助 减少血管内膜损伤和血栓形成。这项工作将在体外使用 模拟导管插入，并将重点放在材料和工艺 植入式医疗设备中使用的SMT聚合物的优化， 包括设计更复杂的导尿管。形状记忆的塞尔丁格 导管/护套将在第二阶段完全开发，应适用于 各种诊断和治疗设备的快速插入， 包括X光导管、主动脉内球囊、股分流术 血管成形术设备和导管安装的血泵。

DESCRIPTION: (Adapted from investigator's abstract) This study would determine the feasibility of producing a combination Seldinger catheter/insertion sheath from their softenable, shape-memory thermoplastic (SMT). This device would simplify insertion of venous and arterial catheters by combining puncture, dilation and sheath placement in a single device. The SMT would be compounded and pelletized, then extruded as a high modulus, thin-walled, radiopaque tube, which will be post-formed to have an approximately 16 gauge distal tip. The remainder of the catheter body would be French 8 or larger. Upon reaching 37 degrees C, the tapered tip would expand to the larger diameter of the proximal end of the sheath, to permit catheter insertion with an optional guide wire. During expansion, the SMT will undergo a stiffness reduction, which should help reduce intimal damage and thrombosis. This work will use in vitro simulation of catheter insertion, and will stress material and process optimization of SMT polymers for use in implantable medical devices, including catheters of more complex design. The shape-memory Seldinger catheter/sheath, to be fully developed in Phase II, should be useful for rapid insertion of a variety of diagnostic and therapeutic devices, including radiography catheters, intraaortic balloons, femoral shunts angioplasty devices and catheter-mounted blood pumps.