SBIR-STTR Award

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 efficacyin 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 AbsorbableStaple, 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 arecarried 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 indexedonto 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.

Public Health Relevance:
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). Theshortcomings 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, isapplicable to long and short incisions and Opus intends to commercialize it broadly through partnerships with larger medical companies.

Thesaurus Terms:
Animals;Area;Base;Bathing;Blind;Caliber;Cost;Design;Devices;Dimensions;Excision;Family Suidae;Funding;Generations;Goals;Health Personnel;Iacuc;Improved;Indexing;Investments;Laboratories;Leg;Marketing;Meat;Medical;Medical Device;Medical Schools;Metals;Methods;Minimally Invasive Surgical Procedures;Modeling;Molds;Needles;Needlestick Injuries;New Technology;Operative Surgical Procedures;Patients;Performance;Phase;Physicians;Physicians'offices;Pilot Projects;Plastics;Poly(L-Lactide);Protocols Documentation;Public Health Medicine (Field);Research;Research Study;Right-On;Risk;Safety;Savings;Skills;Skin;Small Business Innovation Research Grant;Surgeon;Surgical Incisions;Surgical Research;Surgical Staplers;Surgical Sutures;Techniques;Technology;Tensile Strength;Time;Tissues;Tool;Tubular Formation;Visit;Work;Wound;Wound Healing

The surgeon's choice of method for closing incisions is becoming increasingly problematic. Metal surgical staples are unacceptable for Minimally Invasive Surgery (MIS) procedures (currently 25 percent of surgeries in the US) and are out of favor in traditional procedures due to complications and the cost of staple removal. Due to the time required for manually applied sutures, many surgeons are trying skin adhesives, but with mixed results as these should be used only in limited applications. Other devices attempting to address these problems have not been accepted for a variety of reasons. The founders of Opus KSD have developed a bioabsorbable fastener and a disposable, hand-held stapler able to insert the preloaded fasteners subcutaneously to close surgical incisions. This novel surgical device provides the speed and convenience of a metal stapler and the improved healing of a bioabsorbable suture, resulting in improved outcomes for patients and savings to the healthcare system. The technological innovation which allows the plastic SubQ It! fastener, weighing only 0.006 grams, to replace a metal staple that is significantly heavier and stronger, is the unique "hybrid" design that compliments the plastic with the strength and sharpness of surgical needles only during insertion. After insertion, the needles are retracted within the stapler, leaving in siu only the bioabsorbable plastic. Barbs on the fastener engage the tissue and the excellent tensile strength of plastic holds the two sides of the incision in the desired everted shape for optimal healing. The successful Phase I study demonstrated excellent performance in a porcine wound healing model with superior performance discovered for traditional, longer incisions, which were requested by FDA. The Specific Aims for Phase II are to extend the capability of the stapler device outside the MIS market to address these longer, traditional incisions. The Long Term Goal is to replace metal staples and hand-applied sutures with bioabsorbable fasteners in the majority of the skin closure procedures world-wide. In the US, there are 3 million MIS procedures and an estimated 4.5 million other procedures that could be closed if the product from this Phase II effort is successful. At an end-user price of $40-45 each, this represents a Commercial opportunity of $300 million in the US alone.

Public Health Relevance Statement:


Public Health Relevance:
In this Phase II SBIR, Opus KSD proposes to expand the capability of a new surgical device which delivers subcuticular bioabsorbable fasteners for closing surgical incisions. The initial focus of the product was short minimally invasive incisions However, a very successful Phase I SBIR study demonstrated excellent healing with minimum scars and no infection or rupturing, for long and short incisions. Extending the device's capability to address these longer incisions is relevant to the public health because it can improve patient outcomes for many traditional incisions (less scarring and no need to return to have sutures/staples removed) and reduce time and risk of needle stick injury for the surgeon.

Project Terms:
Address; Adhesives; Adoption; Area; biomaterial compatibility; Cicatrix; commercial application; cost; design; Devices; Excision; Family suidae; feeding; Generations; Goals; Hand; Healed; healing; Health; Healthcare Systems; Hybrids; improved; Infection; Journals; Left; Leg; Legal patent; Marketing; Medical Device; Metals; Methods; minimally invasive; Modeling; Needles; Needlestick Injuries; novel; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; phase 1 study; Plastics; Price; Procedures; Production; Property; public health medicine (field); response; Risk; Rupture; Savings; Shapes; Side; skills; Skin; Small Business Innovation Research Grant; Speed (motion); Surgeon; Surgical incisions; Surgical Staplers; Surgical Staples; Surgical Stapling; Surgical sutures; System; technological innovation; Tensile Strength; Testing; Thick; Time; Tissues; Trocars; Wound Healing