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Bioswellable Absorbable Monofilament Sutures

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85680
Program Year/Program:
2007 / SBIR
Agency Tracking Number:
GM079808
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
POLY-MED, INC.
POLY-MED, INC. 6309 HWY 187 ANDERSON, SC 29625
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Bioswellable Absorbable Monofilament Sutures
Agency: HHS
Contract: 1R43GM079808-01
Award Amount: $100,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Most mechanical ligations of living tissues using surgical sutures require a combination of a thread and needle combination. In most cases, the needle diameter far exceeds that of the suture, which can result in leakage of bodily fluids, including blood, through needle-created holes about implanted suture thread. Depending on the surgical site, this can lead to bleeding and infection. A few attempts have been made in earlier decades to minimize needle hole leakage withou t a clinically optimum solution. This prompted the pursuit of the proposed study to explore development and evaluation of a first generation of swellable sutures with a focus on the absorbable monofilament type and those for use in laparoscopy and microsur gery. Accordingly, Phase I objective is synthesis of absorbable amphiphilic polyether esters and their evaluation for use as bioswellable absorbable sutures. And Phase I plans entail (1) synthesis and characterization of several absorbable crystalline poly ether esters; (2) conversion of selected copolymers to monofilaments under established conditions to provide optimum mechanical properties; (3) in vitro evaluation of non-sterile monofilaments for basic suture properties; (4) selection of candidate monofil aments for fast and delayed absorption profiles and completion of their in vivo breaking strength retention; (5) selection of two compositions to produce bioswellable, compliant monofilament sutures having fast and delayed absorption profiles for Phase II study. This entails polymer/suture development and scale-up studies and initiation of preclinical studies. Development of novel bioswellable surgical sutures will help minimize or eliminate suture- and needle-hole bleeding/leakage and associated blood loss and infection during and after surgery.

Principal Investigator:

Shalaby W. Shalaby
8646468544
SHALABY@POLY-MED.COM

Business Contact:

Joanne E. Shalaby
Small Business Information at Submission:

POLY-MED, INC.
POLY-MED, INC. 6309 HWY 187 ANDERSON, SC 29625

EIN/Tax ID: 570981494
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No