Mass production of orthopedic implants

摘要

A plurality of individual medical devices is created that define a medical device family. Within the family of medical devices, each of the plurality of medical devices has at least one dimension that, within an acceptable tolerance, is substantially equal to the same dimension of another of the plurality of medical devices. Thus, for each medical device in the family, another, corresponding medical device has at least one substantially similar dimension. For example, a first medical device may have a first value for a dimension and a second medical device may have a second value for the same dimension that is equal to one of the sum of the second dimension and the acceptable tolerance or the difference between the second dimension and the acceptable tolerance. Thus, each of the plurality of medical devices varies from another of the plurality of medical devices by the acceptable tolerance.

主权项

1. A method of manufacturing a plurality of medical devices for a patient population configured to replicate a portion of the anatomy of patients within the patient population in at least one dimension, the method comprising the steps of:
identifying the patient population; establishing a maximum value for the at least one dimension that corresponds to a patient within the patient population having a high value for the at least one dimension; establishing a minimum value for the at least one dimension that corresponds to a patient within the patient population having a low value for the at least one dimension; determining an acceptable tolerance within the patient population for the at least one dimension; and manufacturing a plurality of medical devices configured to replicate a portion of the anatomy of the patients in the at least one dimension, a first medical device of the plurality of medical devices having a first value for the at least one dimension substantially equal to the minimum value, a second medical device of the plurality of medical devices having a second value for the at least one dimension, wherein the second value is both greater than the first value and substantially equal to or less than the sum of the first value and the acceptable tolerance, and a third medical device of the plurality of medical devices having a third value for the at least one dimension substantially equal to the maximum value.