Bioswellable Absorbable Monofilament Sutures

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$100,000.00
Award Year:
2007
Program:
SBIR
Phase:
Phase I
Contract:
1R43GM079808-01
Award Id:
85680
Agency Tracking Number:
GM079808
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
POLY-MED, INC., 6309 HWY 187, ANDERSON, SC, 29625
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
839420742
Principal Investigator:
SHALABY SHALABY
(864) 646-8544
SHALABY@POLY-MED.COM
Business Contact:
JOANNE SHALABY
() -
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 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.

* information listed above is at the time of submission.

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