Nanofibrous materials as drug, protein, or genetic release vehicles
Inventors
Phaneuf, Matthew D. • Brown, Philip J. • Bide, Martin J.
Assignees
Rhode Island Board of Education • Clemson University • Biosurfaces Inc
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Publication Number
US-10328032-B2
Publication Date
2019-06-25
Expiration Date
Abstract
The present invention is a bioactive, nanofibrous material construct which is manufactured using a unique electrospinning perfusion methodology. One embodiment provides a nanofibrous biocomposite material formed as a discrete textile fabric from a prepared liquid admixture of (i) a non-biodegradable durable synthetic polymer; (ii) a biologically active agent; and (iii) a liquid organic carrier. These biologically-active agents are chemical compounds which retain their recognized biological activity both before and after becoming non-permanently bound to the formed textile material; and will become subsequently released in-situ as discrete freely mobile agents from the fabric upon uptake of water from the ambient environment.
Core Innovation
The invention provides an electrospinning perfusion method for forming a fabricated textile comprising nanofibers suitable for use as a medical article. The method includes dissolving a non-biodegradable polymer together with a biologically-active agent in an organic solvent to provide an admixture, and the dissolving step occurs at about 4°C.
The admixture is loaded into an electrospinning perfusion instrument, where an electric current of 15–20 kV is applied to a needle of the instrument. The perfusion process perfuses the admixture onto a target surface at about 25°C, producing perfused nanofibers having a diameter from 100 nm to 3000 nm, and trace solvent is removed to form a biologically-active fabricated textile.
The described approach is directed to maintaining biologically-active functionality through the fabrication process and forming a durable fabricated textile with nanofibers sized for medical article use. The textile formats include tubular and flat/planar sheet formats, and the document further describes in-situ release upon water uptake of biologically active compounds from the nanofibers after the textile is formed.
Documented examples include electrospinning perfusion using non-biodegradable polymer textiles with biologically active agents such as antibiotics, antifungals, and anti-neoplastics, including ciprofloxacin, fluconazole, and paclitaxel. The resulting nanofibers are supported by evidence of successful incorporation and bioactivity assessments, along with release profiles and activity assays over extended periods.
Claims Coverage
The independent claim defines an electrospinning perfusion method with defined polymer/admixture preparation, electrospinning perfusion conditions, nanofiber diameter range, and solvent removal to obtain a biologically-active fabricated textile for a medical article. Four inventive features are identified across the independent claim content.
Electrospinning perfusion method for biologically-active medical textile
An electrospinning perfusion method for forming a fabricated textile comprising nanofibers suitable for use as a medical article, including dissolving a non-biodegradable polymer and a biologically-active agent in an organic solvent at about 4°C to provide an admixture, then loading the admixture into an electrospinning perfusion instrument.
Non-biodegradable polymer constraint excluding specific polymers
The method wherein the non-biodegradable polymer is not polytetrafluoroethylene, polypropylene, or polyethylene.
Electrospinning perfusion conditions to form defined nanofiber diameter
Applying an electric current of 15–20 kV to a needle and perfusing the admixture onto a target surface at a temperature of about 25°C to provide perfused nanofibers each having a diameter from 100 nm to 3000 nm.
Trace solvent removal to obtain a biologically-active fabricated textile
Permitting trace solvent to be removed from the perfused nanofibers to form a biologically-active fabricated textile.
Overall, the claim coverage centers on producing a biologically-active fabricated textile by dissolving a non-biodegradable polymer, excluding specified polymers, with a biologically-active agent at about 4°C, electrospinning/perfusing at about 25°C using 15–20 kV to generate nanofibers of 100–3000 nm diameter, and permitting trace solvent removal to yield the biologically-active textile for medical article use.
Stated Advantages
Supports fabrication at defined temperatures while preserving biologically-active functionality.
Permits a controlled sustained elution concept of incorporated biologically active compounds after water uptake.
Provides durability of the fabricated textile.
Maintains bioactivity of incorporated biologically active agents after incorporation.
Documented Applications
Vascular grafts.
Hemodialysis access grafts.
VAD conduits.
Sewing cuffs.
Bioactive sutures.
Wound dressings.
Stent coatings.
Dermal substitutes.
Bone fixation pin coatings.
Pediatric catheter cuffs.
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