Impact
Contributing to the development of metal alloys for an improved patient experience
Objective
Improve patient outcomes by helping medical device manufacturers to understand wear of artificial joints.
Approach
Laboratory analysis of blood samples collected from subjects with artificial joints allows the measurement of metals in the subjects due to wear of their joints.
Impact
Our client used our results to make an informed decision between two different materials for manufacturing their next generation of artificial joints. Results from the early trial helped them to identify the candidate material to move forward in the manufacturing process, reducing development cost and time to market for the joint.
As life expectancies increase and people strive to remain active in their older age, the need for medical devices such as artificial joints continues to grow. Joint manufacturers continually work to improve the durability and functionality of their products, requiring the development of new alloys used in their production. Understanding the wear characteristics of these materials is a key component of continued development of joints. Replacement joints can shed particles into the blood stream as the joint wears down, and these particles produce elevated metal concentrations in the subjects’ blood. The amount of metal that wears in an artificial joint is generally small and the portion of the worn material that makes it into the bloodstream is a fraction of that, which makes its detection very challenging.
Specialized Lab for Analyzing Trace Amounts of Metals
The analytical laboratories at RTI are equipped with specialized instrumentation for analysis of metals, including multiple inductively coupled plasma systems for trace metal analysis. RTI is one of only a few contract laboratories with a high-resolution Sector Field ICP-MS instrument, which can detect as little as a picogram of toxic metals in blood and other types of samples. This instrument also features high resolution, which allows it to avoid common interferences that can pose challenges for measuring iron, nickel, vanadium, and chromium.
Since many of these metals are also found in the environment, extensive measures are needed to make sure that samples are not contaminated and that the results tell researchers what metals are the result of wear. Laboratories need a metal-free space to perform sample preparation and analysis in biological samples. RTI’s laboratories have several such spaces designed specifically to allow the analysis of ultra-trace elements and ensure that high-quality data is produced.
We developed and verified an analysis method within a week of project kick off. During the project, we analyzed over a hundred blood samples for metals, using a specialized preparation method that would ensure high quality data for difficult metals like titanium.
Creating Safer, More Advanced Artificial Joints
The precise measurement of trace wear metals in artificial joints provided information to the manufacturer that was used to evaluate the best alloy for their next generation of joints. In addition to guiding product development decisions, similar methodology can be used to assess product life cycles of joints or other medical devices with metal components, helping to ensure that patient safety and cost efficacy are at the forefront of any product development project. Utilizing advanced instrumentation to collect data to improve artificial joint safety is one example of how RTI uses science to adhere to our core principle of improving the human condition.
