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An Adaptable Solution
“Most orthopedic devices are designed for strength – this provides obvious immediate benefit but can be ultimately detrimental to the long term remodeling of the bone and surrounding tissues”Design and Development Services
Common stress effects are easily observed with metal bone screws and implants. In an effort to ease the interface between implant and native tissue, designers have developed new materials, chemical modifications, and manufacturing processes to improve tissue response and, ultimately, patient outcome.
Ligament repair is often performed with a suture anchored into the bone and point attachments through the ligament tissue in several places. This replaces a broader area point of attachment than the natural connection, but can often fail under high loads due to stress concentrations. To improve this outcome, a specialized orthopedic company was seeking to develop an integral scaffold into a bone anchor / suture device to encourage successful attachment between the tissues over a broader area.
The company was looking for a fibrous mat that could be secured to the device flexible enough to be applied using a minimally invasive surgical approach. To reduce changes to the surgical procedure, the company wanted to keep the new device as similar as possible to the existing product. The company sought out Poly-Med to collaborate on developing a new strategy and product requirements.
The company and Poly-Med worked together to identify input requirements, select materials, and screen various processes to test for suitability. Early in development, electrospinning was identified as a primary candidate for design. To create an optimum environment for bone and ligament attachment, other material parameters were also determined – such as wettability, flexibility, and required functional life.
The developed product incorporated a multilayered electrospun fibrous scaffold that was attached to the existing product, which could be folded for loading into the same trocar for delivery.
A multilayered electrospun fabric was developed containing Osteoprene® 8812 and Aquaprene® 6728, which was shown in early trials to create improved bond strength at the bone / ligament interface after 6 months in vivo. Poly-Med continues to support the company through supply of electrospun sheets for cutting, bonding, folding, and loading to finish the product as well as analytics towards submitting a 510(k) for the device.
“Available materials and processes, along with knowledgeable engineering staff, have been a key component in developing our product.” – VP of New Product Development at a medium size orthopedic company