Importance

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Abstract

An implanted single or dual lumen device for repeated accessing of a vessel within a body, especially for hemodialysis, plasmapheresis, and other fluid exchange therapy treatments. The device is characterized by having: no septum for sealing but having instead a resilient material to form a seal; a smooth, streamlined flowpath with low flow resistance and substantially no stagnation points, such that the device is easily and completely flushed; optionally a gradually changing direction of flow path without introducing flow resistance or stagnation points with a change in direction of up to 20 degrees with a minimum bend radius of twice the lumen diameter or up to 30 degrees with a minimum bend radius of four times the lumen diameter; and a positive locking mechanism that accepts and retains a matching needle apparatus. The device is joined to a catheter, in most cases, such that fluids can be extracted from or injected into the vessel or vessels to be accessed. The device is designed for the high flow rates, on the order of 400 milliliters per minute, associated with hemodialysis, plasmapheresis, and other fluid exchange therapies. A corresponding needle apparatus is designed to mate and lock with the access device, where alignment and open flow path is ensured. The needle apparatus first penetrates the skin and then the access device via the seal. The access device is flexibly mounted to the body at the attached catheter allowing the device itself to move under the skin so as to accommodate and align with the needle apparatus.

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First Claim