Use of additive manufacturing processes in the manufacture of custom wearable and/or implantable medical devices

摘要

A method for manufacturing a custom wearable and/or implantable medical device, such as an orthosis (e.g., an ankle brace, etc.), a prosthesis or the like, includes use of scanning processes. A digital model of a surface may be applied to a digital device model to define a custom digital device model. The digital model and, thus, the custom digital device model may include one or more standard features. The custom digital device model may be used with an automated manufacturing process to make some or all of the custom wearable and/or implantable medical device. In some embodiments, additive manufacturing processes may be used to form a portion or all of the custom wearable and/or implantable medical device.

主权项

1. A method for fabricating a custom wearable and/or implantable medical device, comprising:
scanning a body part for which the custom wearable and/or implantable medical device is to be made to provide data for generating a digital body model of the body part, the scanning including dynamically scanning the body part for which the custom wearable and/or implantable medical device is to be made to obtain a plurality of scans of the body part that correspond to a plurality of positions of the body part during movement of the body part; generating the digital body model of the body part for which the custom wearable and/or implantable medical device is to be made, the digital body model including custom surface data corresponding to at least one surface of the body part; applying the digital body model to a digital device model to incorporate the custom surface data into a customizable area of the digital device model to create a custom digital device model; and using the custom digital device model to fabricate the custom wearable and/or implantable medical device for use on the body part; including:
analyzing data from the plurality of scans to identify at least one location of the body part that is subject to undesired motion or movement during movement of the body part; andfabricating the custom wearable and/or implantable medical device to:
include at least one rigid region to prevent the undesired motion or movement of the at least one location of the body part; andinclude at least one flexible region to enable natural movement of unaffected locations of the body part.