INDWELLING FISTULA ACCESS DEVICE FOR HEMODIALYSIS

有效的血液透析需要250-300 ml/min的血流量。 获取这种血液的常用方法是将两个大的 针插入瘘管（动脉化静脉）或移植物（PTFE导管 动脉和静脉之间）。 两个针头在手术结束时取出， 每一次治疗。 这项建议的目的是进一步发展一个 瘘管评估装置（农发基金），可插入瘘管 或移植物，留在原地数周或数月，并用于 多次血液透析治疗。 血液通路将是 迅速无痛不流血 农发基金将由两种尺寸的不锈钢制成 针料 一个20号针头与点焊接到 17号针头的前部，靠近较大针头的侧孔 (for血液移除或返回）。 先插小针 插入瘘管或移植物，旋转针头 皮肤，在那里放置一个帽来关闭它并稳定皮肤。 设备. 旋转也带来了17号的侧孔 用针插入瘘管 动物实验用类似的16号 设备已经表明，农发基金可以留在原地长达4 月，无凝血、静脉炎或感染。 这个令人印象深刻 生物相容性是由于器械的固定， 避免针尖在瘘管内的创伤。 在这个项目中，体外试验将确定液压 农发基金的阻力。 动物实验将确定 寿命长，生物相容性，抗感染， 移除装置。 如果这些测试成功， 将准备提案提交给FDA，用于人类 设备的测试。

Effective hemodialysis requires a blood flow of 250-300 ml/min. The usual method for obtaining this blood is placing two large needles into a fistula (arterialized vein) or a graft (PTFE conduit between artery and vein). Both needles are removed at the end of each treatment. The objective of this proposal is to further develop an Indwelling Fistula Assess Device (IFAD) which can be inserted into a fistula or graft, left in place for several weeks or months, and used for numerous hemodialysis treatments. Blood access would then be rapid, painless, and bloodless. The IFAD will be constructed from two sizes of stainless steel needle stock. A 20 gauge needle with point is welded into the front of a 17 gauge needle, near a sidehole in the larger needle (for blood removal or return). The small needle is inserted first into the fistula or graft, and rotation brings this needle through the skin, where a cap is placed to close it and to stabilize the device. The rotation also brings the side hole of the 17 gauge needle into the fistula. Animal tests with a similar 16 gauge device have shown that the IFAD can be left in place for up to 4 months, without clotting, phlebitis, or infection. This impressive biocompatibility is due to immobilization of the device, and to avoiding the trauma of a needle point within the fistula. During this project, in vitro tests will determine the hydraulic resistance of the IFAD. Animal tests will determine the longevity, biocompatibility, resistance to infection, and ease of removal of the device. If these tests are successful, an IDE proposal will be prepared for submission to FDA, for human testing of the device.