Single-Use Delivery Device for Bioabsorbable Fasteners

DESCRIPTION provided by applicant The surgeonandapos s choice of method for closing incisions is becoming increasingly problematic Metal surgical staples are unacceptable for Minimally Invasive Surgery MIS procedures currently 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 grams to replace a metal staple that is significantly heavier and stronger is the unique andquot hybridandquot 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 million MIS procedures and an estimated million other procedures that could be closed if the product from this Phase II effort is successful At an end user price of $ each this represents a Commercial opportunity of $ million in the US alone 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 deviceandapos 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