MAGNETICALLY OPERATED ARTIFICIAL URETHRAL SPHINCTER

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 13838
Amount: $500,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1993
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
Whalen Biomedical Inc.
5 Howland St, Cambridge, MA, 02138
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Robert L Whalen
 (617) 661-3693
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THE OBJECTIVE OF THIS PROGRAM IS THE DEVELOPMENT OF A NEW PROSTHESIS FOR THE TREATMENT OF TOTAL URINARY INCONTINENCE. THE PROSTHESIS IS MAGNETICALLY OPERATED WITH AN EXTERNALLY WORN PERMANENT MAGNET. THE MAGNET COMPRESSES AN IMPLANTED METAL BELLOWS, WHICH PRESSURIZES A URETHRAL CUFF TO STOP THEFLOW OF URINE. THE CUFF PRESSURE IS SET AT THE TIME OF IMPLANTATION, BUT IT IS LATER PERCUTANEOUSLY ADJUSTABLE USING AN INJECTION PORT ON THE BODY OF THE RESERVOIR. THE ADVANTAGES OF THIS DEVICE INCLUDE SIMPLICITY, MECHANICALRELIABILITY, EASE OF USE, AND SAFETY. FAILURE OF THE IMPLANT DOES NOT RESULT IN URETHRAL BLOCKAGE, AND THE PROSTHESIS CAN BE USED BY PATIENTS WITH POOR DEXTERITY, BOTHLIMITATIONS OF EXISTING DEVICES. THE FLUID RESERVOIR/BELLOWS ASSEMBLY IS ENCASED IN A SILICONE RUBBER JACKET THAT EMPLOYS A MICROPOROUS TEXTURED SURFACE TO LIMIT FIBROUS TISSUE ENCAPSULATION OF THE PROSTHESIS, WHICH MIGHT ALTER DEVICE FUNCTION OVER LONG PERIODS OF TIME. PROTOTYPE DEVICES WILL BE CONSTRUCTED, AND THE PERFORMANCE OF THE CUFF AND MAGNETIC ACTUATION SYSTEM STUDIED IN VIVO. TO ASSESS THE SAFETY OF THE EXTERNAL MAGNET, A SERIES OF ANIMAL EXPERIMENTS WILL BE PERFORMED USING MINIATURE PIGS TO STUDY THE POTENTIAL FOR SKIN TRAUMA. THE SKIN AND SUBCUTANEOUS TISSUE UNDER THE EXTERNAL MAGNET WILL BE EXAMINED FOR EVIDENCE OF PRESSURE NECROSIS, AND THE TISSUE CAPSULES FROM THE MICROPOROUS SURFACE WILL BE EXAMINED HISTOLOGICALLY AND COMPARED WITH SMOOTH SURFACE CONTROL IMPLANTS. THE NEW DEVICE WILL BE ESPECIALLY USEFUL FOR ELDERLY PATIENTS.

* information listed above is at the time of submission.

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