TECHNOLOGY DISCLOSURE

 

A Multi-Functional Bioactive Wound Dressing Surface

 

Inventors:

 

Matthew D. Phaneuf, B.S.

BioSurfaces

Ashland, MA

(508) 881-8860

biosurfaces@verizon.net

Frank W. LoGerfo, M.D.

Chief, Division of Vascular Surgery

Beth Israel Deaconess Medical Center

Boston, MA

(617) 632-9955

flogerfo@caregroup.harvard.edu

Martin J. Bide, Ph.D., Susan L. Hannel, Ph.D

Department of Textiles, Fashion Merchandising and Design

University of Rhode Island

Kingston, RI

(401) 874-2276

mbide@uri.edu,  susanhannel@uri.edu

 

Trauma, results in significant morbidity and mortality.  In 2002, over 400,000 trauma cases were reported in the United States, more than one third of them fatal.  Around 40% of these deaths are attributed to uncontrolled bleeding.  Overall, trauma costs the healthcare system $260 billion or 12% of total medical spending.  

 

A combination of specific biological (e.g. infection-resistant, enhanced hemostatic) properties is desirable, together with appropriate physical (e.g. adjustable compression, flexible application method, durability, compactness, ease of application) attributes.  Incorporated into a single device, these properties will provide a novel wound dressing to save a person with peripheral injuries.  

 

We have developed a novel lightweight bioactive compression wound dressing that provides durable infection-resistance and localized hemostatic properties.  A polyester (Dacron) material with polyurethane inlayed into the structure is utilized as the base material to provide the required physical properties (i.e. elasticity, durability).  The surface is modified to develop functional groups.  An antibiotic (Ciprofloxacin) is incorporated into the material via textile dyeing technology, and a biologically-active protein, thrombin, a pivotal enzyme in the blood coagulation cascade, is covalently attached to the modified surface.  

 

The invention is based on several elements of our experimental work published and/or patented over the past decade, plus recent work to demonstrate the effectiveness of the technologies working together.  These include; the application of Cipro on polyester: the original technology[1],,[2],,[3] and new data to show that it is applicable to bifunctionalized polyester, and on polyester that has had bioactive proteins attached, the modification of polyester by treatment with EDA[4], the attachment of proteins, both model[5], and bioactive proteins in work that shows them to maintain their activity when attached[6], plus new data to show that thrombin is similarly active when attached.

 

The full disclosure reveals

         Detailed experimental data for the treatment with ethylene diamine to produce both amine and carboxylic acid groups on the polyester in a single step, and the means for their determination, both qualitatively and quantitatively.  The effect of the treatment on the gross physical properties of the material is also examined.  It is shown that a polyurethane material included to provide stretch and compression to a knitted polyester is unaffected by the treatment.

·         The incorporation of Ciprofloxacin into this bifunctionalized polyester, using a method modified from the original to fully maintain the functionality generated by the EDA treatment

·         The durability to extended washing of the infection resistance of the Cipro-treated material, via a zone-of-inhibition test.  The resistance persisted to 5 days and beyond, whereas untreated material had no activity and material treated by simple “dipping” lost activity in 1 hour.

·         The successful covalent linking of thrombin via cross-linking reagents to the polyester surface.

·         The maintenance of the antibiotic activity of the material after the series of steps required to link the thrombin

·         The activity of the bound thrombin in promoting clot formation.  This was achieved in vitro using a chromogenic assay, and ex vivo by exposing the surface to whole blood.  Electron microscopy was used to show the initiation of fibrin formation within one minute, with thrombus formation evident in less than 5 minutes

 

We have gone so far as to develop a novel proprietary lightweight compression wound dressing prototype.  The design allows for rapid application and adjustment by medical personnel or the injured person themselves, and incorporates the infection resistant and clot promoting surface.

 

Return to Martin Bide's page

 

 

[1] M. Phaneuf, C.K. Ozaki, M.J. Bide, W. Quist, J. Alessi, G. Tannenbaum, F. LoGerfo, "Application of the Quinolone Antibiotic Ciprofloxacin to Dacron using Textile Dyeing Technology", Journal of Biomedical Materials Research 27 (1993) 233.

 

[2] M. J. Bide, C. K. Ozaki, M. Phaneuf, W. Quist, F. LoGerfo,  "The Use of Dyeing Technology in Biomedical Applications".  Textile Chemist and Colorist  25, No. 12 (January 1993) 15  

 

[3] C. K. Ozaki, M. Phaneuf, M.J. Bide, W. Quist, J. Alessi, F. LoGerfo, "In vivo Testing of an Infection Resistant Vascular Graft Material", Journal of Surgical Research 55, No.5 (November 1993) 543-547

 

[4] M. J. Bide, T. Zhong, J. Ukponmwan, M. D. Phaneuf, F. W. LoGerfo, W. C. Quist.  . “Bifunctional surface modification of polyester”, Proceedings, A.A.T.C.C. 2002 International Conference and Exhibition and AATCC Review, 3 No. 11 (November 2003) 24.

 

[5] M D Phaneuf, W C Quist, M J Bide and F. LoGerfo “Modification of polyethylene terephthalate (Dacron) via denier reduction: effects on material tensile strength, weight and protein binding capabilities”, Journal of Applied Biomaterials 6 (1995) 289

 

[6] M D Phaneuf, S. A. Berceli, M J Bide, W C Quist, and F. LoGerfo, “Covalent linkage of recombinant hirudin to polyethylene terephthalate (Dacron): creation of a novel antithrombin surface” Biomaterials 18 (1997) 75