Medical Device With Orbital Forming of Locking Mechanism
Developing Locking Mechanism for Spinal Support Plate
Posted on 05/08/2017 | by The Orbitform Blog Team
Medical devices present unique challenges to the engineering and manufacturing world since many medical devices work inside the human body or are even permanently installed inside the human body. Thus, the medical device must be clean, smooth, safe, secure, dependable, and simple to install.
A surgical implant medical device company approached Orbitform for help with the development of a small locking mechanism they were proving out. The locking mechanism was a critical component of their spinal support plate assembly product. The toggling part being orbitally formed was very small (4mm) and was made of a very hard material, titanium.
There were several product, process, and surgeon-use design requirements needing to be met, including:
1.) The orbital forming process could not damage the plate the toggle lock was being assembled to. There could be no visible marring.
2.) No burrs could be present after the orbital forming process since any burrs could potentially fall off the plate during surgical implantation. The assembly was to undergo microscopic inspection after the orbital forming process for verification.
3.) The rivet extension below the bottom surface of the plate was to be minimized as the maximum height of the finished and formed assembly could not exceed 2.2 mm.
4.) The minimum load requirement of the rotating retainer was 100N.
5.) The retainer had to rotate freely from the unlocked position to the locked position.
6.) Any material transfer between the orbital forming peen and the work piece had to be minimized as the customer was to analyze the presence of any material transferred from the peen that imbedded into the formed components.
Orbitform’s product design engineering team and our customer solutions lab technicians worked together to develop the part holding fixture, the orbital forming peen, and the riveting process controls such as forming force and forming pressure. The crew then went about assembling several spinal plates for the customer to evaluate.
We look forward to receiving feedback on this new medical device and we certainly are ready to design and build an Orbitform orbital riveting machine to assemble these important surgical implants.
If you think this type of assembly process analysis or product design support could help your manufacturing operation, please contact us by clicking here.