The goal of this project is to develop a multi-suture delivery device capable of inserting bioabsorbable fasteners, with improved cost/performance over all other skin closure methods, and demonstrate safety and efficacy in animal trials. Traditional stitches and metal staples penetrate through the skin, restrict the patient from bathing and must be removed, somewhat painfully, in a return visit to the physician's office. The preferred alternative is to place stitches subcutaneously using bioabsorbable suture material which remains beneath the skin and is absorbed by the body over time. This technique, however, is more time consuming than surgical staplers, and requires the skill and includes the risk of "needle stick" of traditional stitches. An ideal skin closure method would be a stapler which inserts bioabsorbable staples beneath the skin saving the surgeon time and risk, and not requiring the patient to return for suture removal. Such a product, the Insorb Absorbable Staple, has been FDA cleared since April 2003, but has not gained significant acceptance. The applicants believe this is because the device is a first generation effort to solve a very difficult problem. As a result it is more complicated and significantly more expensive than surgical staplers, uses a relatively large mass of plastic in closing long incisions, and cannot be used at all in the smaller incisions of increasingly popular Minimally Invasive Surgical (MIS) procedures. Dr. Kenneth Danielson, a surgeon and founder of OPUS KSD, Inc., has developed at private expense, a bioabsorbable fastener with significantly less mass than the Insorb Absorbable Staple and able to be inserted by a simple tool. The fastener has two tubular legs with barbs which are carried on two metal needles and inserted from above the wound. The insertion tool used in experiments to date is a manually operated device which holds a single fastener The insertion tool offers excellent visibility to the surgeon, unlike the blind use of the Insorb device, and has been demonstrated in closing long incisions as well as incisions as small as 7mm (a 5mm trochar as used in MIS procedures creates a 7-8mm incision). The proposed project is to develop a disposable stapler which can reliably index fasteners from a cartridge holding 10-20 fasteners. The design of a disposable stapler is challenging because of the critical dimensions needed for proper alignment of tissues and the precise deployment of the fastener. The fasteners must be "indexed" onto a pair of needles which must "hit" holes that are less than 0.5 mm in diameter. The fastener must then pass through the center of a space within which the tissue is placed with a gap less than 0.5mm larger than the fastener.
The aims of Phase I will be to develop the multi-fastener insertion device and demonstrate performance of the device and the fasteners in animal trials at Dartmouth Medical School's Surgical Research Laboratory.
The goal of this project is to develop a multi-suture delivery device capable of delivering subcuticular bioabsorbable fasteners. This work is relevant to the public health because the new technology offers improved cost/performance over all other skin closure methods (see table below). The shortcomings of current methods and the advantages of the Opus technology are most apparent for closing the small incisions used in Minimally Invasive Surgical (MIS) procedures. This will be the first market for Opus but the technology once developed, is applicable to long and short incisions and Opus intends to commercialize it broadly through partnerships with larger medical companies.