Medical Device and Its Manufacture

摘要

A biodegradable medical device including at least one biodegradable material and having an initial shape and at least one evolved shape. The evolved shape is different from the initial shape. The initial shape is adapted to change towards the evolved shape due to an external stimulus. The medical device has a tension loaded to a predetermined tension level. The medical device is adapted to resore the tension to the predetermined tension level for at least 2 weeks in physiological conditions, or conditions simulating the physiological conditions.

主权项

1. A biodegradable orthopedic device for bone fracture fixation, said device being formed of one piece and comprising a continuous elongated shaft made of at least one biodegradable polymer material having an oriented polymer structure so as to have a predetermined tension level of between 5N and 260N;
the device having an initial shape and at least one evolved shape, the at least one evolved shape being different from the initial shape, and the initial shape being adapted to change towards the at least one evolved shape due to an external stimulus, wherein the change includes a full length longitudinal shrinking and a full length radial expansion of the continuous elongated shaft, such that the full length longitudinal shrinkage of said device pulls bone fragments together thereby tightening the bone fragment fixation, and wherein the external stimulus is an aqueous environment and temperature of 35 to 42° C.