PTC Awards Entry
Auto Suture GIA™ w/DST™ Surgical Stapler
Randy Lehn, Laszlo Rethy, Robert Pedros, Kevin Slisz, Luis Dussan, Rich Bronson, Frank Viola, Dave Coope, Joe Oskwarek, Russell Sherwood
US SURGICAL/TYCO HEALTHCARE
PTC Creo Parametric
The Auto Suture Next Generation GIA™ Stapler is a single patient use disposable stapler capable of up to eight firings. The reloadable cartridges are available in three staple line lengths (100mm, 80mm, 60mm) and 3 different height staple sizes (4.8mm, 3.8mm, and 2.5mm). The 100mm instrument contains 104 titanium staples, the 80mm has 84 staples and the 60mm has 64 staples. The Auto Suture GIA™ stapler significantly reduces operative time by delivering two double staggered rows (4 rows) of titanium surgical staples separated by a knife cut creating an anastomosis (joining of tissue). Its primary use is for transection, resection and anastomosis of tissues in the thoracic, abdominal, and pelvic areas of the body. The Next Generation GIA™ stapler is used in a wide variety of procedures around the world including the increasingly popular gastric bypass or stomach reduction procedure.
United States Surgical’s (USS) design team took full advantage of Pro/ENGINEER, Mechanism Design and the Pro/MECHANICA modules to produce a smarter more innovative design. USS each year manufactures and sells approximately four hundred thousand GIATM Staplers among all three sizes. USS also sells several hundred thousand SULU’s (Single Use Loading Units), the staple cartridges used with the GIATM Stapler. The savings are significant when you translate the manufacturing savings cost of key components that were achieved/developed through the use of PTC modules. The combination of PTC technologies allowed the groups to collaborate to produce complex component designs quickly, and get it right the first time by using up-front, concurrent validation of all the critical components. This up-front validation of the critical components with PTC analysis modules gave the team the confidence they needed to go directly to production tooling on several components, saving over $100,000 in prototype molds, and shortening the launch of the product by several months.
The new Auto Suture Next Generation GIA™ Stapler has several unique and innovative features that distinguish it from the herd. It uses our proprietary staple technology called Directional Stapling Technology (DST™). Conventional surgical staplers use U-shaped staples formed from wire that has a round cross-section. These staples are pressed through tissue layers until they reach a metal anvil where they take the form of a B-shape. A staple formed of round wire has no predetermined direction in which to bend, therefore the likely hood of the “B” forming out of plane or being diverted out of plane by an abnormality while penetrating the tissue is high, resulting in a malformed staple. The Next Generation GIA™ staples are also U-shaped but have more of a rectangular shaped cross-section – the staples are approximately thirty percent thinner in their “bending” direction. This cross-section provides the optimal shape for perfect staple formation because it biases the staple in the correct direction and prevents the staple from bending out of plane reducing the likelihood of a malformed staple. The Auto Suture Next Generation GIATM has a unique proprietary adjustment component that allows our assembly line to individually “pre-set” the distance between the staple cartridge and anvil forming surfaces accurately within .002” on every instrument. This feature minimizes the variability or tolerance stack of components and helps ensure proper staple formation. The new Auto Suture Next Generation GIA™ is the first disposable surgical stapler of its type with “soft grips”. Two-shot molding was incorporated on the instrument bodies to provide a soft, comfortable, non-slip grip to the surgeon.