Design of a Subcutaneous Vascular Access Device Using Ni-Ti SMA Clamps for Hemodialysis

Abstract

A subcutaneous vascular access device which utilizes an Ni-Ti shape memory alloy (Ni-Ti SMA) spring, has been developed as a new method for subcutaneous vascular access in the treatment of hemodialysis patients. Until now, the connection between the SVAD and needle cannot be externally monitored, and the clamp must be opened and closed with a percutaneous needle by a nephrologist.

The SMA-SVAD accomplishes the opening and closing of its clamp using two Ni-Ti SMA springs, and a transcutaneous energy transmission system (TET) transmits energy to the Ni-Ti SMA springs without the need for percutaneous wires. Two SMA springs open and close the clamp of the SMA-SVAD, without affecting any of the other parts of the system. Wasted thermal energy is reduced to minimal values via electrical regional heating methods. The state of the SMA-SVAD can be monitored according to the amount of power consumed by the external energy transmitter.

In in-vitro experiments, when the clamp was opened and the pressure difference in the hemodialysis machine was set to 50 mmHg, water flow through SMA-SVAD reached 500 ml/min. The maximal surface temperatures of the SVAD and catheter were successfully maintained at proper levels (38~39°C), 2~3 degrees higher than the temperature of the surrounding tissues. The time elapsed from the initiation of energy transmission until the opening of the SMA clamp was 5 seconds.