Bioswellable Absorbable Monofilament Sutures

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43GM079808-01
Agency Tracking Number: GM079808
Amount: $100,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2007
Solicitation Year: 2007
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
POLY-MED, INC., 6309 HWY 187, ANDERSON, SC, 29625
DUNS: 839420742
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 SHALABY SHALABY
 (864) 646-8544
 SHALABY@POLY-MED.COM
Business Contact
 JOANNE SHALABY
Phone: (864) 646-8544
Email: shalaby@poly-med.com
Research Institution
N/A
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 without 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 microsurgery. 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 polyether 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 monofilaments 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.

* Information listed above is at the time of submission. *

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