SBIR-STTR Award

AUTOMATIC SUTURING AND LIGATING DEVICE technology forms a completed stitch of absorbable or nonabsorbable polymer monofilament in second, even in areas of limited access such as laparoscopic surgery. Suture is threaded through tissue, tensioned, cut to length and welded in place using a proprietary process. This research seeks to demonstrate the feasibility of suturing using this device and method and establish its equivalency to knotted sutures. This will be accomplished by building a development prototype device, mechanical testing of sutures formed by the device to the requirements of USP XXIII and other standards, and a histological examination of the effects of the suturing process in both acute and chronic studies in an animal model. Proving equivalency to conventional sutures is a vital step toward development of a procedure-specific commercial product to be developed in Phase II

AUTOMATIC SUTURlNG AND LlGATlNG DEVICE technology forms a completed stitch of absorbable or nonabsorbable polymer monofilament in seconds, even in areas of limited access such as laparoscopic surgery. Suture is threaded through tissue, tensioned, cut to length and welded in place using a proprietary process. Proof-of-principle was successfully demonstrated in Phase I where: 1) A fully automated prototype suturing instrument was built, 2) Welding process experiments demonstrated consistent, high strength welds exceeding the USP specifications in a variety of suture materials, and 3) Animal testing demonstrated the benign nature of the welding process. Phase Il seeks to bring this revolutionary wound closure technology to the point of commercial application through commercial product development, expanded research into core technologies, surgical procedure specific animal studies and preparation and submittal of the regulator approval application. PROPOSED COMMERCIAL APPLICATIONS: AUTOMATIC SUTURING AND LIGATING DEVICE development is a key element in the development of a line of fully automated suturing and ligating products, patented by the principal investigator. These devices, applicable to virtually every form of wound closure, promise significant savings in wound closure time, and therefore cost, as well as improvements in safety and opportunities for less invasive surgery