During abdominal surgeries, surgeons must separate the intestines from the operative site. Ten percent of all surgeries performed in the United States of America require bowel packing. Current bowel packing procedures utilize cotton sponges and towels which can abrade and dehydrate the peritoneal lining as well as depositing loose fibers which remain in the patient after surgery. Cotton sponges and towels move easily and may have to be replaced as often as 4-6 times during a procedure adding 20-30 minutes to the length of the procedure (approximately $1,000 per surgery).
Cotton bowel packing materials also contribute to the formation of adhesions, which are bands of tissue connecting previously separate organs. There is a 60% chance of post-operative adhesions, 70% reoccurrence rate, 380,000 additional surgeries, and $14 billion spent on treatment resulting from current bowel packing methods. Other complications include higher infection rates and chronic discomfort, which result in negative publicity for hospitals and surgeons. Cotton packs can be also be forgotten and left inside the patient, an error that occurs in approximately 1,500 cases annually, at a cost of $50,000 per case (Gawande, Atul. "Risk Factors for Retained Instruments and Sponges after Surgery." New England Journal of Medicine 348 (2003): 229-335).
Clinical Objectives:
The primary goal for Lap-Pak is to reduce bowel packing time by 50%. Use of Lap-pak during laparotomies ensures interoperability with retractors, facilitates monitoring of bowels, and maintains tissue temperature and hydration.
Instrument Specifications:
The Lap-Pak device is a one-piece device constructed from a soft and flexible material that is easy to position.. It contains a stable body support that evenly distributes pressure. Side and bottom flaps contour against the abdominal walls to prevent movement and allow for varied cavity sizes. The dual top flaps shield the bowels while maintaining visibility of the intestines as well as internal temperature and moisture. The product will be offered in three sizes designed to fit over 80% of adults.
Competitive Landscape:
There are currently three technologies on the market that deal with bowel packing, including cotton packs, Seprafilm®, Interceed®, and DASH®. Two other products in addition to Lap-Pak that are in development but not yet commercially available, however none of these products have reduced surgery time and complications or matched the simple elegance of Lap-Pak.
