A non-woven absorbable scaffold has been designed for implant devices in orthopedics, cardiology, and general surgery, as well as other in vivo applications. Where classic tissue engineering utilized non-woven textile structures as environments for cell growth, medical device developers are now going further to exploit the benefits of these bioabsorbable scaffolds for applications and surgical procedures right inside the body, as well as for cosmetic surgery, wound care, and more. BIOFELT combines the benefits of traditional 3D non-woven scaffold technology with advanced manufacturing techniques to deliver this transformative capability.
BIOFELT is a non-woven structure created by a carding and needle-punch process that is customized to each device application. Unlike woven or knitted textiles created with yarns, non-woven structures are produced by interlocking very short fibers or filaments together to create a felt with high surface area. Polymers are initially combed and separated, and then bonded together using a needle bed and loom to position them. The type of needle, number of punches per measured area, number of layers, and amount of fiber entanglement within the layers are all designed-in to create a structure with the necessary properties to facilitate growth of natural tissue and internal regeneration. Processing techniques can be tailored to produce specific filament spacing within the felt and customized thickness to support this tissue in-growth. Advanced engineering can also manipulate the stiffness of the finished textile for mechanical imitation of human tissue. Other commonly engineered properties customized for specific applications and performance include density and absorption profile.
To deliver the performance required for implant applications in many different areas of the body, BIOFELT is designed to be shaped in a variety of geometries, including flat felts, tubes, cuffs, cones, and more. As implants, BIOFELT structures are built with biocompatible materials in Class 7 cleanrooms for total traceability and medical-grade quality control. Putting careful controls in place to monitor humidity levels, track and prevent exposure, and ensure repeatability in manufacturing are all necessary to both maintain process validation and deliver on a variety of application-specific needs for all kinds of scaffolds.
Applications for Device Design
As a scaffold, BIOFELT is used to create three-dimensional environments for cell proliferation and function. Its fibrous matrix platform is composed of absorbable biomaterials (carefully chosen based on mechanical function and clinical application) and enables the regrowth of new cells before disintegration. The result is a completely natural tissue in place of the eroded polymer. Common materials include polyglycolic acid (PGA), poly-L lactic acid (PLLA), and poly(lactic-co-glycolic acid) (PLGA), but BIOFELT can also be manufactured with proprietary fibers for customer-specific functional requirements. All BIOFELT structures are biocompatible, and choice of polymer and a specialized engineering process allow for differing absorption profiles from 30 days to 1 year.
Applications in dental and urological surgery, and cardiovascular and orthopedic tissue regeneration for arteries, heart valves, and cartilage are all beneficiaries of non-woven textile technology. Orthopedic reconstruction procedures in particular have begun to more significantly explore the potential of absorbable structures that allow for natural cellular in-growth. For tendon repair and other load-bearing applications, for example, the scaffold must act in a dual capacity following its implantation in the body. Temporarily, it must provide the mechanical function of the replaced tissue, while at the same time providing an environment that enables regrowth of natural tissue. It must also shield this growing tissue from full physiological stress, at first taking on the brunt of the load-bearing responsibility, and then gradually transferring it to the new, self-reliant tissue as it degrades.
Increasingly, non-woven technology is providing performance characteristics in a more lifelike, natural way than ever before. For medical device developers, the possibilities for implants are only just beginning.
This technology was done by Biomedical Structures (BMS), Warwick, RI. For more information, visit http://info.hotims.com/40434-186.