The specially developed scaffolene ® spinneret technology sets new standards in the implementation of medical technology products. Using this process, bioresorbable nonwovens can be produced at low temperatures without harmful solvents. This prevents damage to the sensitive bioresorbable polymers during processing.
Under clean-room conditions, we produce nonwovens by spinning natural or synthetic biopolymers. Thanks to the variable 3D structure of the nonwovens and the possibility of incorporating active ingredients in the fiber during the spinning process, scaffolene ® technology opens up an broad spectrum of medical applications.
Chronic wounds which heal poorly still represent a challenge in modern medicine. One of the main problems is the lack of epithelialization, i.e. the growth of epithelial cells over the wound. Epithelialization may start from intact tissue at the edge of the wound. If necessary this process can be accelerated by a complex full-thickness skin graft from other body locations.
The need for the frequent changing of dressings, thereby causing irritation to the regenerating epithelial tissue, is one of the apparently unsolved problems in wound treatment. Our bioresorbable nonwoven does not need to be removed and therefore does not cause pain or damage to the wound edge when dressings are changed. When treating chronic wounds, it is desirable to avoid a full-thickness skin graft. This might be possible by using the bioresorbable nonwoven.
Due to the special 3D structure with defined fibers and porosity, our nonwoven also could be suitable for regeneration or replacement of deeper skin structures. This allows the nonwoven to be used as a dermis replacement providing the space and framework for soft tissue regeneration under a split-thickness skin graft.
With certain indications it may be beneficial to incorporate antimicrobial additives in the nonwoven.
A large number of fabrics similar to nonwovens are currently used in modern biosurgery. One field of application is intra-operative hemostasis. Following operations, hemostatic materials are left in place where bleeding may occur (e.g. venous plexuses in the pelvic region). However, there are handling problems with the materials now used, as they are either too brittle when dry or insufficiently stable when wet.
Nonwovens produced by scaffolene ® technology are flexible when dry and retain stable even when wet thanks to the hydrogel-like consistency. They do not adhere to themselves and are easy to restore to shape. The material is convenient to use and the positioning and fixing of the nonwoven is made considerably easier.
These properties of our nonwovens open up new applications. A particularly growing field of applications is endoscopic surgery. Nonwovens based on scaffolene ® technology can be applied in dry or wet condition through both standard 10 mm ports and smaller 5 mm ports and can be easily unfolded and positioned in the abdominal cavity. The bioresorbable properties and the time in the body can be adapted to the requirements of specific applications.
Thanks to the gentle spinning process used, scaffolene ® technology allows bioactive substances to be incorporated directly into the fibers. The properties of the nonwoven can therefore be specifically tailored to the needs of biosurgical applications. For example, thrombin may be added to obtain hemostatic properties, antibiotics can be integrated where an antibacterial effect is needed and it is possible to use hydrogels in nonwovens for adhesion prevention.
One key advantage of scaffolene ® technology is the gentle process used for nonwoven production, at low temperature without harmful solvents and polymeric degradation. Therefore it is possible to incorporate thermally unstable active ingredients into the nonwoven. These may include proteins such as growth factors and enzymes, hormones or other bioactive substances. These possibilities open up a wide range of innovative applications in regenerative medicine.
Potential applications include trauma surgery and orthopedics. The efficacy of growth factors such as Bone Morphogenic Proteins (BMP) has already been demonstrated in clinical tests. With scaffolene ® technology, a growth factor can now be incorporated directly into the fibers of the nonwoven. As the nonwoven is fixed in the position required and the enzyme is continuously released by degradation of the fibers, the growth factor remains in place for a defined time.
One key advantage of these nonwovens is their 3D structure. The nonwoven forms a scaffold of fibers which can act as a guiding structure for cellular migration. As the fibers themselves may be enriched with other matrix polymers or additives such as collagen, hydroxyapatite or hyaluronic acid, the cells find substrates which they can use for cellular regeneration. The fibers surround large cavities into which cells penetrate, forming connective tissue. This may be especially important for clinical applications where the objective is to replace soft tissue, bone or cartilage.
scaffolene ® technology processes natural or synthetic biopolymers by spinning in an especially gentle process without harmful solvents at low temperatures which do not affect polymers or other thermally unstable substances. During the spinning process, such bioactive ingredients can therefore be directly integrated into the fibers of the nonwoven. Pharmaceutical ingredients are released locally in a controlled way by the degradation of the fabric. This may reduce quantities of bioactive substances used, which are often costly, at the same time as maintaining high local concentrations of active ingredients even over a long time.
The scaffolene ® production process allows a considerably wider range of antibiotics and bioactive substances to be used than was previously the case. scaffolene ® technology also opens up new prospects for applications where high local concentrations are required while minimizing systemic toxicity. This is a typical requirement in oncology. Taking the example of malignant tumors of the ovaries, stomach or pancreas, metastases may be scattered throughout the abdominal cavity by peritoneal fluid. In such cases, a nonwoven which is biocompatible and bioresorbable and releases cytostatic over a period of weeks may prove to be beneficial.
Biotechnology is creating a greater understanding of substances occurring naturally in the body, biologicals which may accelerate the healing process or replace or regenerate lost body functions. In this area too, bioresorbable nonwovens produced by the gentle scaffolene ® process will open up new possibilities.
Within the Corporate Function Innovation, Freudenberg New Technologies is the competent partner to strengthen the innovative drive of the Freudenberg Group and to safeguard its technological edge.
Freudenberg New Technologies developed a unique technology platform which addresses different medical challenges in surgery, wound treatment and regenerative medicine: this is the proprietary bioresorbable nonwoven technology called “scaffolene”.
We use scaffolene technology to develop and produce bioresorbable nonwovens in Germany for customers in the medical device, biotechnology and pharmaceutical industries throughout the world. We manufacture products that are then commercialized and marketed by our partners.
All our medical and pharmaceutical products conform to relevant quality standards.