Transcript Document
BMEG450: Senior Design, Fall 2013 A Novel Fat Removal Tool for Human Tissue Brandon Boles, Audrey Guyer, Ryan Mitchell, Krunal Parikh, Matthew Ringer Overview Concept Generation Final Design Background Information Concept Selection Prototype LifeCell™ Corporation processes donated human skin tissue into allografts to be used in surgeries. Currently, scalpels (see Figure 1) are used to remove the fat layer from the dermis before further processing takes place. The current technique leads to a non-uniform product and worker injury. Figure 1: Scalpel blade and handle The Product LifeCell™ aims to alleviate safety concerns and improve the uniformity of their final allograft products by implementing a new fat removal system to replace the use of scalpels. Project Scope The scope of the project is to develop a functional prototype to remove adipose tissue from the dermal layer of donated human skin while also promoting technician safety and increasing functionality over the current process. Metrics Metrics were developed in consultation with LifeCell™ to address the project constraints (see Table 1). Table 1: Metrics for the fat removal tool Metric Technician Incidents: No puncture wounds Technician Fatigue: 50% reduction Fat Removal: 100 % fat removal Dermal damage: 80% reduction Cost: $20 disposable cost C A Figure 2: Concepts A, B, and C B Concept A (see Figure 2) was selected based on discussions with LifeCell™. This device incorporates a bumper system that will protect the dermal layer, an electrical component that reduces worker fatigue, longitudinal motion that will reduce worker injury, a blade replacement mechanism, and a trigger to activate the device. Design Process First Generation This prototype featured a permanently installed stainless steel blade on the Remington™ HC5550. The prototype was tested on pork belly (Figure 3) to simulate donated human skin, as highlighted in green, and it was compared to a static blade (red). The stainless steel blades have a serrated cutting edge and are held in place by a 3-pin system. The blades are removable by unscrewing the stainless steel bumper. See Figure 6 for a model of the final design. Figure 3: Pork Belly test Second Generation This prototype featured a removable stainless steel razor blade held in place by a 3-pin system. A blade guard made of Delrin was installed above the blade mechanism to prevent adipose tissue from entering the device. This prototype was also tested on pork belly, as seen in Figure 4. Third Generation This prototype incorporated a trigger button mechanism to increase control and minimize potential harm to the technicians. This prototype was tested on human tissue at LifeCell™ in Branchburg, New Jersey (see Figure 5). In order for the design to be implemented, it must be superior in comparison to the current scalpel technique. Figure 4: Blade with pin system A qualitative feedback survey was administered to the technicians at LifeCell™. The survey includes questions on -ease of use -learning curve -comfort -functionality -dermal damage Constraint Safety Figure 6. Final design The final design is an 18,000 rpm motor with a torque rating of 771 gcm. It is powered by 3-6 V of rechargeable batteries that are in circuit with a safety toggle switch and trigger button to initiate blade movement. Figure 5: Visit to LifeCell Testing Plan Testing of the final design was completed by the senior design team and technicians at LifeCell™. The final design was used in removing adipose tissue from human skin, and the new design was rated against the current scalpel method for each metric. Validation Fourth Generation This prototype incorporated a modified stainless steel bumper below the blade in order to minimize the possibility of human error in terms of inflicting dermal damage during fat removal. As well, this prototype used a blade with curved edges to promote cutting. The feedback from LifeCell™ was used to validate the final design against the project metrics. Functionality Acknowledgements Cost-efficient We would like to thank our sponsor, LifeCell™ Corporation, our advisor Dr. Anita Singh, as well as Mr. Beard and the rest of the Senior Design Staff. After hand-off of the final prototype to the sponsor, the path forward will be to produce an autoclavable replica for evaluation and eventual commercial use by technicians in the class 100 cleanrooms at LifeCell™. Safety Functionality Path Forward