1. Currently, there are several products on the market that could accomplish our goals but they have not been modified for use in nasal cavities. The Single Use Suture Device (see Figure 1) is designed for tissues and can place a circular suture that will attach two “tube-shaped” or “flat” sections together. It is not made, however, to physically pass a needle through something and back through in the other direction, as would be needed to suture skin flaps to a nasal septum. The GIA Reloadable Stapler (see Figure 2) and others of its kind are simple in design but have tips that are too broad for use in the nose and which cannot be lined up properly as they are presently found. The possibility exists of adapting one of these devices for use in the nose, but it may require parts that are smaller than those currently being manufactured or additional, more specific modifications. Testing was conducted as follows: Stapler was fired twenty times into four different thicknesses of Play-Doh TM, which simulated different septum widths. Percentage deployment was measured by the amount of the staple that was not flush with the plane of the septum after being fired. Misfires were counted as 0% deployment. This will need to be re-tested when the bottom plate can be modified to crimp the staples. Abstract Design Criteria References Acknowledgments Mollie Lange, Peter Ma, Tim Pearce, Kuya Takami Advisor: Dr. Kristyn Masters Client: Dr. Ben Marcus, Otolaryngologist Future Work Problem Definition Definitions – Rhinoplasty surgery is used to modify the shape and size of a patient’s nose. Septoplasty is a surgery that corrects any deformation of nasal septum (the straight bone down the center of the nose). Suturing is the surgical method in which fine threads or other materials, such as staples, to join two surfaces and edges together along a line. Motivation – Our goal is to develop a device which will automatically deploy a suture to a specific region of the nose which is detached during two common nasal surgeries, rhinoplasty and septoplasty. The current procedure is tedious and time consuming for the performing surgeon, often taking 15 minutes or more and making OR time very costly to the patient. Our client would like to develop a device which will automatically suture the desired location with minimal surgeon involvement. The ideal device would reduce both surgeon error and operating time, resulting in a more effective suture. Current Devices Final Design Prototype Testing Suturing of some kind is required for nearly every form of nasal surgery. In many other surgical disciplines, machines have been developed that can deploy sutures in less time and with much less effort than when done by hand. No such device exists for septoplasty or rhinoplasty, two very common operations that require similar suturing techniques after surgery. To this point, the small size of the nasal passage as well as difficulty in maneuvering have prevented nasal autosuture devices from being designed. The goal of our project was to reduce the amount of time and effort necessary to securely suture within the nose, bearing in mind the safety of the patient and comfort of the surgeon. Our team has designed and built a new surgical stapler which models the type of device that can be manufactured in large quantities. The results of early testing show a rate of 95% of shots fired being successful. Modify the bottom plate to crimp staples. Explore the possibility creating absorbable staples that will fit into our device. Gain access to more advanced tools and technology to more accurately create moving parts. Make device disposable at lowest possible cost by using plastic for hemostat handles. Run test trials on cadavers and clinical patients. The final design for our device is comprised of a modified steel hemostat, three aluminum plates, and steel rods. The function is much like an ordinary paper stapler, but fires three staples at a time and fits in the nasal cavity. United States Surgical. “DST SeriesTM GIATM Single Use Reloadable Staplers,” Autosuture.com Product Page. Retrieved 20 October 2006. United States Surgical. “Endo StitchTM 10mm Suturing Device,” Autosuture.com Product Page. Retrieved 20 October 2006. Steichen F, Ravitch M. Stapling in Surgery. Year Book Medical Publishers, Inc. Chicago, Illinois 1994. Thanks to Andy Mulder (Psychology Dept), Evan and Jake in the ECB Student Shop, and to our client and advisor for their continued advice and support. Figure 1: Single Use Suture Device Figure 2: GIA Reloadable Stapler  Performance: A one time device or a reusable device is acceptable.  Safety: Patient and surgeon safety cannot be compromised by the use of the device.  Accuracy and Reliability: Doctor should be in control of exact placement.  Life in Service: If disposable, one use only. If reusable, a maximum number of surgeries should be preformed with a single device based on further research.  Shelf Life: A comparable shelf life of other single use devices (6 months) should be met.  Operating Environment: The device should only be used within the operating room.  Size: Maximum length should fit in nose (approximately 2 cm)  Weight: Should be comfortable to hold with one hand (less than one pound).  Materials: Materials compatible with sterility. Plastic, metal. Must be disposable or autoclavable. The body of this device (see Figure 3) is a modified steel hemostat, which has been bent to allow penetration into the nasal cavity without compressing the skin at the tip of the nose. Figure 3: Nasal Stapler Figure 4: Top Plate The top plate (see Figure 4) has been designed with raised posts which can push the loaded staples all the way through the middle plate, forcing them through the septum as well. Figure 5: Middle Plate The middle plate (see Figure 5) has been designed to hold the staples in place when the device is open and loaded, then to allow them to be pushed through by the top plate and direct them in a straight path through the skin and septum as the stapler is closed. The middle plate also creates pressure by holding the skin in place. Figure 6: Bottom Plate The bottom plate (see Figure 6) holds the opposite skin flap in place next to the septum and stops the staple when it has reached the other side. Ideally the bottom plate will be designed to crimp the staples in place as pressure is applied.