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DEVELOPMENT OF A COMPLIANT HEMODIALYSIS ACCESS GRAFT

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
11455
Program Year/Program:
1989 / SBIR
Agency Tracking Number:
11455
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Thoratec Laboratories Corp
2023 8th St Berkeley, CA 94710
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 1989
Title: DEVELOPMENT OF A COMPLIANT HEMODIALYSIS ACCESS GRAFT
Agency: HHS
Contract: N/A
Award Amount: $49,984.00
 

Abstract:

A COMPLIANT VASCULAR GRAFT FABRICATED FROM A UNIQUE POLYURETHANE MATERIAL HAS BEEN DEVELOPED AND TESTED AS A 4-MM-DIAMETER PROSTHESIS. THE MATERIAL USED IS UNIQUE BECAUSE ITS BULK AND SURFACE REQUIREMENTS HAVE BEEN SEPARATED AND DEVELOPED INDEPENDENTLY IN TWO DISTINCT MATERIALS. THE FINAL POLYMER POSSESSES OVERALL OPTIMIZED CHARACTERISTICS BY BLENDING OPTIMIZED SURFACE-ACTIVE COPOLYMERS INTO THE OPTIMIZED BULK MATERIAL. USING A PATENTED PROCESS FOR FABRICATION OF MULTILAYERED TUBING, 6-MM-DIAMETER VASCULAR GRAFTS WILL BE PRODUCED. THESE GRAFTS WILL BE TESTED BOTH IN VIVO AND IN VITRO. IN VITRO TESTING WILL INCLUDE COMPLIANCE, BURST STRENGTH, KINK RADIUS, ELONGATION, AND SUTURE PULLOUT STRENGTH. IN VIVO EVALUATION WILL BE ACCOMPLISHED USING 30-CM-LONG CONDUITS TO CREATE AN ARTERIOVENOUS (AV) FISTULA BETWEEN THEEXTERNAL CAROTID ARTERY AND IPSILATERAL EXTERNAL JUGULAR VEIN. DIRECT AV FISTULAS WILL ALSO BE CONSTRUCTED. POLYTETRAFLUOROETHYLENE (PTFE) CONDUITS WILL SERVE AS COMPARISONS. SOME CONDUITS WILL BE PUNCTURED 6 TIMES WEEKLY FOR 12 WEEKS. EXPLANTED GRAFTS WILL BE RESUBJECTED TO THE IN VITRO TEST PROTOCOL AS WELL AS STANDARD MICROSCOPIC EXAMINATION. IT IS EXPECTED THAT THESE GRAFTS WILL HEAL INTO THE VASCULARSYSTEM AND PROVE MORE DURABLE THAN PTFE CONDUITS AS WELL AS PROVIDING FEATURES SUCH AS SELF-SEALING, DECREASED THROMBUS FORMATION, AND LESS INTIMAL HYPERPLASIA.

Principal Investigator:


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Business Contact:

Small Business Information at Submission:

Thoratec Laboratories Corp
2023 8th St Berkeley, CA 94710

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