Heat treating solutions are important for more than keeping an airplane flying in the sky or a bridge suspended above the water. These two examples are high profile, but what about the heat treating solutions that do not zoom through the air or mark the skyline above rivers? In the medical industry, heat treating solutions are often unseen unless something goes wrong.
When it comes to medical implant and device heat treating, what options are available to manufacturers that will benefit patients? What should we know about the heat treating processes that make metal parts functional as knees, hips, and elbows? Find out in this expert analysis from Quintus Technologies and ECM USA, Inc.
This Technical Tuesday article was first published in Heat Treat Today's December 2022 Medical and Energy print edition.
Introduction
Dan McCurdy, former president at Bodycote, Automotive and General Industrial Heat Treatment for North America and Asia, knows full well just how much time, energy, and pain the right medical heat treating practice and alloy composition can save a patient. Dan’s wife suffered from complications due to a nickel allergy in a traditionally thermally-processed ASTM F75 knee implant. She dealt with constant inflammation, swelling, and pain. Physical therapy and a second procedure did nothing to ease the discomfort. The best medicine for Dan’s wife? A specially heat treated medical implant (more of Dan's story can be found at the end of this article).
To understand the stories behind final medical products, Heat Treat Today asked Quintus Technologies and ECM USA, Inc. to share two different approaches on medical implant and device heat treatment. These two companies at the forefront of the medical heat treating industry shared about hot isostatic pressing (HIP) with additive manufacturing, and vacuum heat treating. Read their answers to our questions and learn how, when it comes to implantable medical devices, heat treating can be the best medicine.
How do you ensure your equipment maintains the precise specifications required in the medical industry? What specifically is necessary to maintain compliance when it comes to medical implants?
Quintus Technologies
Applications Engineer
Quintus Technologies
Quintus Technologies has observed a trend in bringing Nadcap to the medical industry. Historically the medical industry has focused on the standards and regulations for the quality management system of their approved supplier, but a consistent transition to technical aspects of critical processes (including HIPing) is becoming the norm. Quintus Technologies’ background is one of delivering HIP equipment in line with Nadcap and AMS2750 specifications. The medical industry requires best-in-class temperature uniformity and accuracy; systems designed with production driven flexibility (such as thermocouple quick-connectors for T/C sensor installation
to minimize downtime); HIP furnaces equipped with uniform rapid cooling (URC®) for optimized cycle productivity; active involvement in standards committees; and working directly with the industry.
Requirements are increasing in terms of productivity and the introduction of more complex surface requirements. It is crucial to work closely with the industry to reduce oxidation of orthopedic implants during the HIP and heat treatment processes.
Steering of the HIP cycle is key, along with in-HIP heat treatments to achieve the desired microstructure for the application, which is a standard offering for High Pressure Heat Treatment™ (HPHT™) equipment.
ECM USA, Inc.
General Manager
ECM USA, Inc.
Some of the features that are most important are leak rate at deep vacuum along with a chamber and furnace design that does not contribute to any contamination. In our systems, these features, along with others, are of the utmost importance when supplying equipment for the medical implant market.
What are the top 3–5 key requirements or compliance/quality issues needed to heat treat medical implants?
Quintus Technologies
There are several industry standards that have been released to establish key requirements for the HIP process that are often leveraged for medical applications demanding performance and reliability. For example, Nadcap has released AC 7102/6 which details the audit criteria for HIP. This document was developed with significant input from the industry and the government to define operational requirements for quality assurance. It offers a checklist for the HIP processing of metal products and includes requirements for:
- managing the equipment per pyrometry standard AMS2750
- qualifying technical instructions and personnel training
- handling product during the loading and unloading operations
- complying with gas purity requirements of the pressure medium
- controlling temperature, including uniformity and accuracy evaluations and management
These aspects are critical to ensure product quality meeting medical customer requirements and expectations. Recent additions beyond conventional requirements highlighted above include high speed cooling in the HIP process (>200 K/min) for some materials which is important for metallurgical results.
ECM USA, Inc.
Key requirements include thermal performance (both uniformity and ramp control); real-time vacuum and gas management; traceability and production lot follow up through human machine interface (HMI); quality procedures for all sensor calibrations; and remote access for control and troubleshooting.
Can you share an example of how your equipment could be used to heat treat a medical implant/device from start to finish?
Quintus Technologies
Many medical implants — whether fabricated using conventional processing techniques such as casting, or more novel approaches such as additive manufacturing — require HIP to eliminate process related material defects. Defects include shrinkage porosity for castings and lack-of-fusion and keyhole defects for fusion based additive manufacturing techniques. These defects can have a negative impact on product quality, impacting performance and reliability. Once HIP has been applied to a material, post processing is often not complete, with additional thermal treatments required to achieve the optimum microstructure leading to the desired material properties and performance. Such thermal treatments are material and process dependent, but could include a stress relief, solution anneal, rapid cooling or quenching, and aging and are often applied in separate heat treat equipment.
Quintus Technologies has introduced HIP systems providing capabilities beyond conventional densification. Decades’ worth of work in equipment design, system functionality, and control now offers an opportunity to perform HIP and heat treatment in a combined cycle, referred to as HPHT. Combined HIP and heat treatment for castings and AM implants can mitigate the risk of thermally induced porosity, as well as grain growth, which can offer advantages for mechanical and chemical properties in implants. This methodology provides a more sustainable processing route with improved productivity and energy efficiency. A joint HIP and heat treatment offers significant advantages with lead time, and this improvement in lead time couples well with the demands placed on the personalized medical implants. It also offers opportunities to further optimize microstructures for improvement in material properties coupled with ease of manufacturability. HPHT and modern HIP equipment may allow for a higher performing material system, which produces an implant with improved reliability and life.
Within the medical industry, fine grain AM microstructure, repeatability, and low porosity are key concerns. There are many reported benefits by applying the combined HPHT route such as reduced number of process steps, reduced cycle time and lead time, and improved process and quality control. Other advantages include spending less time at elevated temperatures helping to preserve the fine grain AM microstructure by minimizing grain growth. Tight control and steering of the cooling rates during the different steps of the HPHT cycle ensures repeatability of the properties. Manufacturability can be improved through HPHT as this approach reduces the cooling or quench severity during cooling segments which can often lead to part distortion or cracking. Improved functionality and
control go hand-in-hand with the high quality and reliability demanded in the medical industry.
ECM USA, Inc.
We have several customers making titanium alloy prothesis for various applications: shoulders, hips. Our furnaces are used for post printing processes, such as stress relieving and solution annealing.
Given concerns of metal poisoning, do you know of any changes in alloy composition of medical devices over the last decade?
Quintus Technologies
There are some metals that are becoming more common for implants, including tantalum, magnesium, CP Titanium, etc., and there have been major steps in improving ceramic materials to compete with metals for many applications.
ECM USA, Inc.
As a vacuum furnace equipment supplier, we are not deeply involved in the entire process of material selection. In the early stages of 3D printing joint replacements, from 2013 to 2014, we saw cobalt being part of some alloys. Lately it seems, indeed, that there is a trend in removing that element from the finished parts.
A Happy Ending
Former president, Bodycote, Automotive and General Industrial Heat Treatment for North America and Asia
(The rest of Dan's story from the beginning of the article....) The effects of metal poisoning and metal allergies post-surgery can be
devastating. In the narrative below, Dan McCurdy shares the story of his wife’s struggle with an allergic reaction to a knee implant, and the heat treating solution that proved to be the best medicine for her.
My wife, an avid runner up and down the hills of Cincinnati, was diagnosed with osteoarthritis in both knees at the age of 53. Her orthopedist suggested a knee replacement for the most degraded one. The replacement was a well-known brand, made from investment-cast ASTM F75 (nominally a Co-Cr-Mo alloy) with full FDA-approval. After a successful surgery and diligent physical therapy, her recovery plateaued, and she experienced chronic inflammation, swelling, and pain.
A blood test, designed to detect allergies to materials used in orthopedic implants, showed a reaction to nickel that was nearly off the charts. We were surprised, as she had previously tested negative for nickel allergies through skin patch testing. The ASTM F75 specification allows for up to 0.5% bulk nickel as a tramp element in implantable devices; however, depending on foundry practices, the concentration of tramp alloys at any point on the surface of a casting can vary significantly. Titanium implants may be the solution to this, but FDA-approved titanium alloys can still contain up to 0.1% Ni.
The solution for my wife, as it turned out, was a different material, originally developed for the nuclear industry, along with an innovative heat treatment process. Created with an alloy of zirconium and niobium (with a maximum nickel content of 0.0035%), her new knee was heat treated at a high temperature in an oxidizing environment, which converts the soft zirconium surface into hard
ceramic zirconia, increasing hardness and wear resistance. With this specially heat treated implant in place, my wife is back to nearly 10K steps a day.
References
[1] Magnus Ahlfors and Chad Beamer. “Hot Isostatic Pressing for Orthopedic Implants.” quintustechnologies.com/knowledge-center/hot-isostatic-pressing-for-orthopedic-implants. Quintus Technologies. 2020.
[2] Chad Beamer and Derek Denlinger. “Hot Isostatic Pressing: A Seasoned Player with New Technologies in Heat Treatment — Expert Analysis.” www.heattreattoday.com/processes/hot-isostatic-pressing/hot-isostatic-pressing-technical-content/hot-isostatic-pressing-a-seasoned-player-with-new-technologies-in-heat-treatment-expert-analysis/. Heat Treat Today. 2020.
For more information
Contact Chad Beamer at chad.beamer@quintusstream.com
Contact Dennis Beauchesne at DennisBeauchesne@ECM-USA.COM
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