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Development of Extraocular Muscle Prosthesis for Paralytic Strabismus

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93784
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
EY019799
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
INNFOCUS, LLC
INNFOCUS, LLC 12415 SW 136TH AVE, UNIT 3 MIAMI, FL 33186-6488
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: Development of Extraocular Muscle Prosthesis for Paralytic Strabismus
Agency: HHS
Contract: 1R43EY019799-01
Award Amount: $162,538.00
 

Abstract:

DESCRIPTION (provided by applicant): The ultimate goal of this Small Business Innovation Research project is to develop the first generation extraocular muscle prosthetic device designed to correct paralytic strabismus. The focus of Phase I of this project is to refine the design of the prosthesis and to test the limits of the device and its components. A method of measuring extraocular muscle forces will be developed and tested using an animal model. Furthermore, a short-term in vivo animal study to assess the biocompatibility of the device will be performed. A common ophthalmic complication encountered with increasing frequency in functional endoscopic sinus surgery (FESS) is the inadvertent amputation of the medial rectus muscle. Extraocular muscle dysfun ction can also be manifested in cranial nerve palsies or vehicular trauma to the muscles. Consequently, the involved eye will assume a large angle exotropia, and the patient will experience debilitating diplopia and will be unable to adduct or abduct the i nvolved eye. Conventional surgical options typically result in suboptimal outcomes as the eye is permanently tethered to a fixed primary position, limiting ocular movements and forcing the patient to adopt face turns to maintain binocular fusion. These maj or shortcomings call for the need of an alternative remedy in the form of a mechanical prosthetic device to obviate the fixed, locked primary position of the affected eye. The unique features of this extraocular muscle prosthesis include: 1) a coiled Nitin ol spring that possesses inherent stiffness to counterbalance the passive forces of the antagonist eye muscles when the eye is in the primary position but also allows linear elasticity to permit eye movement initiated by an antagonist muscle. The spring al so has inherent recoil tension to restore the eye back to the primary position upon relaxation of the antagonist muscle; 2) a novel biocompatible polymer, poly(styrene-block-isobutylene-block- styrene) or SIBS, that does not elicit significant inflammato ry reaction or encapsulation when implanted and has a safety track record in coronary stent use. This biomaterial is extruded as a protective, elastic envelope that insulates the spring coil from the surrounding orbital tissues; and 3) a titanium, T-shaped bone plate that provides a firm metallic fixation point to the orbit and directs the prosthesis posteriorly from the muscle insertion site towards the apex of the orbit, coinciding with the axis of the paretic muscle that the prosthesis is designed to rep lace. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop an extraocular muscle prosthetic device to correct complex eye muscle misalignment conditions in which effective therapy remains elusive. Conventional surgical options typically result i n suboptimal outcomes as the eye is permanently tethered to a fixed position, unable to rotate. The device developed in this project is designed to permit eye rotations; the Extraocular Muscle Prosthesis is a novel prosthetic device comprised of a new poly meric biomaterial that is extremely biocompatible in the eye and has shown insignificant encapsulation compared to silicone rubber.

Principal Investigator:

Yasushi Kato
3053782651

Business Contact:

Yasushi Kato
ypkato@innovia-llc.com
Small Business Information at Submission:

INNFOCUS, LLC
INNFOCUS, LLC 12415 SW 136TH AVE, UNIT 3 MIAMI, FL 33186

EIN/Tax ID: 156239266
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No