SCAFTEX® Non-Woven Bio-Textile for Implantable Devices
- Created: Tuesday, 01 March 2011
With the ability to encourage cellular in-growth, this material may become increasingly important to orthopedic reconstruction.
Classic tissue engineering utilizes absorbable non-woven biomedical textiles from a variety of fibers to aid in cell growth and proliferation, and medical device companies rely on these materials for implantable devices that must degrade over time. Non-woven bio-textiles such as SCAFTEX® and others have become the material of choice for many tissue engineering and regenerative medicine applications, and with superior surface area, high void volume, and excellent permeability, they are now also increasingly used in a wide variety of restorative applications ranging from orthopedic reconstruction and wound management to cosmetic surgery.
Non-woven textiles are created by a carding and needle-punch process that is adjusted according to application. Unlike woven or knitted textiles, non-woven structures are created not with yarns, but by tangling fibers or filaments 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 entangle 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. (Most commonly engineered properties include spacing, thickness, density, and absorption profile.) Most non-wovens are such scaffolds, used to create three-dimensional environments for cell proliferation and function. Composed of absorbable biomaterials, they enable the re-growth of new cells before disintegration. The result is a completely natural tissue in place of the eroded polymer.
Common absorbable polymers include PGA, PLLA, PLGA, PDO, and associated blends, and depending on the engineering process, can be designed for degradation profiles ranging from less than 30 days to a full year. As implants, all non-woven biomedical textiles must be built with biocompatible materials in Class 7 clean rooms for total traceability and medical-grade quality control. When working with absorbable fibers, careful controls are in place to monitor humidity levels, and all materials are tracked for exposure. BMS’s non-woven engineering and manufacturing process is robust, highly repeatable, scalable, and offers validation advantages over other scaffolds, including organic, decellularized matrices.
Beyond flat felts, unique shapes such as tubes, cuffs, and even cones are possible with non-woven technology. Dimension, density, and lifespan are all important to performance within the body, particularly as new and more innovative applications utilizing these building blocks are developed.
Currently, non-woven textiles are primarily of interest for tissue engineering applications and similar regenerative medicine treatments, but they have also extended into orthopedic and cardiovascular indications for reconstruction, regrowth, and surgical systems. Most notably, the ability to encourage cellular in-growth has become increasingly important to orthopedic reconstruction procedures. Material integrity, specifically as a means of controlling the lifespan of absorbables, helps determine device reliability and can be altered for required performance (and duration of performance) in the body. Tissue engineering, stem cell applications, dental and cosmetic surgery, and trauma treatment all benefit from the lifelike composition and absorbability of non-woven structures.
This technology was done by BMS, Warwick, RI. For more information, visit http://info.hotims.com/34452-162.