Molded Hydrogel Tympanic Membrane Repair Constructs

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$157,910.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
1R43DC011715-01
Award Id:
n/a
Agency Tracking Number:
R43DC011715
Solicitation Year:
2011
Solicitation Topic Code:
NIDCD
Solicitation Number:
PA09-113
Small Business Information
8500 WOLF LAKE DRIVE, SUITE 110, MEMPHIS, TN, 38133-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
030849173
Principal Investigator:
WILSON PRITCHARD
(901) 380-7000
wpritchard@eaglevis.com
Business Contact:
WILSON PRITCHARD
(901) 380-7000
wpritchard@eaglevis.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Tympanic membrane perforations are commonly seen in otology practices and about 150,000 repair surgeries are performed each year in the United States. Current office-based procedures such as paper patch tympanoplasty are relatively ineffective or, like the irritant oil method, require multiple office visits. Surgical procedures including fascia and cartilage tympanoplasty are more effective but are invasive and expensive. One of the simplest and most effective methods of tympanic membrane repair involves insertion of a bobbin- shaped hydrogel construct across the membrane. Previous attempts to use hydrogels to create bobbin-shaped constructs have involved use of either molded collagen or calcium alginate, but neitherof these has been commercialized. The main barriers to commercialization of molded hydrogel constructs are poor mechanical integrity and handling characteristics, lack of cost-effective sterilization methods, difficult manufacturing techniques and inconsistent part dimensions. This study proposes to overcome these barriers by assessing the feasibility of using novel molding techniques to form constructs from two different hydrogel materials. Calcium alginate manufacturing will be streamlined using irreversible thermal gelation with calcium chloride-loaded liposomes. These will be compared to constructs made from concentrated solutions gellan gum, the processing of which is leveraged from knowledge gained by Grace Medical during development and regulatory approval of gellan gum temporary ocular inserts. Analysis of the two materials will include full chemical characterization. The results of the tests will allow a determination based upon cost, performance and manufacturability of the best material to use forin vitro and in vivo biocompatibility testing in Phase II of the project. PUBLIC HEALTH RELEVANCE: This project is intended to benefit those that require repair of the tympanic membrane due to rupture or incomplete healing following removal of tympanostomy tubes. The work will develop an inexpensive, commercially viable tympanic membrane repair construct that will transform tympanoplasty into a minimally invasive, routine and widely-practiced office-based technique. The tympanic membrane repair constructs can drastically reduce cost and improve outcomes as it will replace current, relatively ineffective office-based techniques or effective but expensive operating room-based techniques with a simple 10 minute procedure.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government