Dura Mater Regeneration with A Novel Synthetic, Bilayered Nanofibrous Dural Substitute: An Experimental Study

Abstract

Aim: To create a synthetic nanofibrous dural substitute that overcomes the limitations of current devices by enhancing dural healing via biomimetic nanoscale architecture and supporting both onlaid and sutured implantation. Materials & methods: A custom electrospinning process was used to create a bilayer dural substitute having aligned nanofibers on one side and random nanofibers on the other. Nanoscale architecture was verified using microscopy and macroscale mechanical properties were investigated using tensile testing. Biological response to this device was investigated both in vitro and in a canine duraplasty model. Results & conclusion: Bilayer nanofiber alignment yields a graft having anisotropic mechanical properties with significantly higher strength and suturability than a commercially available collagen matrix. When implanted, the nanofibrous graft prevents leaks and brain tissue adhesions, and encourages dura mater regrowth, performing comparably to the collagen matrix. Both in vitro fibroblast orientation and in vivo dural healing are enhanced by the aligned nanofibers.

Keywords::

• alignment
• collagen matrix
• dural substitute
• dura mater
• duraplasty
• electrospinning
• nanofibers
• polylactic acid
• surgical implant
• tissue engineering

Financial & competing interests disclosure

This study was sponsored solely by NanoNerve, Inc., which has a financial interest in the discussed subject matter and materials. The authors, Kyle Kurpinski and Shyam Patel, are employees of Nanonerve, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Acknowledgements

The authors would like to thank Roy Martin, Jack Risdahl and John Carey (The Integra Group, Brooklyn Park, MN, USA), Randall Carpenter (Twin Cities Histology, Brooklyn Park, MN, USA), Sheree Beam (Preclinical Pathology Consulting Service, Twin Cities, MN, USA) and Song Li (University of California, Berkeley, CA, USA) for providing technical support.

Additional information

Funding

This study was sponsored solely by NanoNerve, Inc., which has a financial interest in the discussed subject matter and materials. The authors, Kyle Kurpinski and Shyam Patel, are employees of Nanonerve, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.