THERAPY COSMESIS

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 4826
Amount: $48,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1986
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Whalen Biomedical Inc
5 Howland Street, Cambridge, MA, 02138
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 ROBERT L WHALEN
 PRINCIPAL INVESTIGATOR
 (617) 661-3693
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THE OBJECTIVE OF THIS PROPOSED PROGRAM IS THE DEVELOPMENT OFTWO TYPES OF BREAST PROSTHESIS FOR COSMETIC CORRECTION OF THE EFFECTS OF MINIMAL BREAST SURGERY AND/OR RADIATION THERAPY. THE PROSTHESES EMPLOY A TEXTURED SURFACE TO PROMOTE TISSUE ATTACHMENT AND MINIMIZE THE FORMATION OF A TISSUE CAPSULE, AND THEIR INTERNAL VOLUME IS PERCUTANEOUSLY ADJUSTABLE TO PERMIT SUBSEQUENT OPTIMIZATION OF THE VOLUME OCCUPIED BY THE PROSTHESIS OR THE DEGREE OF FIRMNESS DESIRED. A READILY METABOLIZED, NONTOXIC FLUID IS USED AS THE CHARGING MEDIUM, AND THE DEVICES THEMSELVES ARE FAB- RICATED FROM SILICONE RUBBER WITH AN INTEGRALLY TEXTURED SURFACE BEING SEPARATELY DEVELOPED. A SERIES OF 18 ANIMAL EXPERIMENTS ARE TO BE USED TO (1) EXAMINE HEALING AROUND THEDEVICES UNDER A WIDE RANGE OF VOLUME AND FIRMNESS; (2) EVALUATE THE SUITABILITY OF THE PERCUTANEOUS FILLING SYSTEM THAT HAS BEEN DESIGNED; AND (3) EVALUATE THE VOLUME STABILITY OF THE IMPLANTED DEVICES. BECAUSE THE TISSUE CAPSULE THICKNESS AROUND THE DEVICES IS CONTROLLED, THE TACTILE SURFACE AND VOLUME OF THE IMPLANTED DEVICES SHOULD BE READILY ADJUSTABLE TO COMPENSATE FOR LATE TISSUE CHANGES OR CONTINUED THERAPY.

* information listed above is at the time of submission.

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