Incorporating a Ferrous Polymer Target into Elastomeric Liners for Socket Fit Sensing in Prosthesis Users.

TLDR: A method to incorporate a thin uniform-thickness layer of conductive or magnetically permeable target material into the wide range of prosthetic liner products that people with limb amputation commonly use to create a consistent calibration result over the entire surface is presented.

Abstract: Liner-to-socket distance measurement using inductive sensing may be an effective means to continuously monitor socket fit in people using trans-tibial prostheses. A practical limitation, however, is a means to incorporate a thin uniform-thickness layer of conductive or magnetically permeable target material into the wide range of prosthetic liner products that people with limb amputation commonly use. In this paper, a method is presented whereby a 0.50-mm thickness ferrous polymer made from a SEEPS polymer and iron powder that is formed adjacent to a 0.25-mm thick non-ferrous layer of SEEPS polymer is assembled between two sheets of elastic fabric material. Bench testing showed that the fabrication procedure achieved a root-mean-square error in the thickness of this construct of 58 μm, helping to create a consistent calibration result over the entire surface. The original fabric backing of an off-the-shelf prosthetic liner was removed and replaced with the developed construct. When worn in the shoe of an able-bodied participant for 7.5 h per day for 28 days, the sensor well maintained the shape of its calibration curve at the start of wear, but a distance offset (shifting of the y-intercept) was introduced that increased during the initial approximately 12 days of wear. When the distance offset was corrected, for the primary distance range of clinical interest for this application (0.00–5.00 mm), the sensor maintained its calibration within 4.4%. Before being used in clinical application for liner-to-socket distance monitoring, new ferrous liners may need to be pre-worn so as to achieve a consistent distance reference.