Improving Patient Safety, Comfort

Metal staples are becoming a thing of the past. Even metal staplers are old news.

Originally, a stapler was made from metal and was a multiple use device. After each use, the stapler would need to be disassembled, sterilized, and then reassembled. On occasion, a part could be misplaced, causing the stapler to no longer function.

Today, Incisive Surgical, collaborating with Sabic Innovative Plastics, have developed the INSORB Subcuticular Skin Stapler that features a consolidated plastic part which has become a disposable device with no need for post-use sterilization.

The use of subcuticular absorbable skin staples for closing incisions dramatically improves surgical outcomes while enhancing patient safety and comfort. The staples combine the superior cosmetic results of absorbable sutures with the rapid closure times of metal skin staples – while eliminating the need for post-operative staple removal.

To precisely and efficiently deliver these staples – while avoiding the risk of needle sticks for patients and clinicians – Incisive Surgical’s engineers worked for more than 18 months with engineers at SABIC on what material would answer their needs for the INSORB success. The result was two grades of SABIC’s Ultem resin. More precisely, selected were the Ultem 1000F unfilled resin and the Ultem 2200 glass-filled (20%) resin, for their ability to deliver all these properties plus excellent aesthetics.

Ultem polyetherimide (PEI) resin provides the strength, sterilization capabilities, and biocompatibility in the necessary custom colors for a number of critical components. Ultem resin is an amorphous thermoplastic polyetherimide offering outstanding high heat resistance, high strength, modulus, and broad chemical resistance.
Mechanical requirement for the INSORB stapler was that it needed high mechanical strength in its nose, arm, and yoke components due to the force of compression during use. Further, these components needed broad sterilization capability while retaining strength and color. Biocompatibility in custom colors and part consolidation were also important characteristics. Another key reason the choice became the Ultem product was that its properties delivered the requirements for the load that gets applied at the palm to clamp the stapler shut and the good compressive strength for the mouth of the stapler to shut. Additionally, it delivered the same ergonomic feel of the metal stapler.

David Stoen, vice president of operations for Incisive Surgical states, “SABIC Innovative Plastics provided invaluable assistance by showcasing different material options for us to choose from at an early stage in the development process. SABIC Innovative Plastics clearly understands the needs of its customers – large and small – and the healthcare industry. The company’s resources, expertise, and services – such as custom color-matching – helped us achieve a first-of-its-kind product.”

In addition to proposing material candidates, SABIC engineers provided the company with ColorXpress color-matching, expedited material delivery, and ongoing support throughout the development process.

“The success of the INSORB Surgical Skin Stapler program is a great example of how SABIC Innovative Plastics seeks to align with customers to assist in the development of their applications,” says Clare Frissora, market director – healthcare for SABIC Innovative Plastics. “It is very rewarding for us to see this innovative device come to life, knowing that we were able to assist with the selection of materials from our broad healthcare portfolio and to provide other needed support capabilities.”

Today, the INSORB skin stapler is in its third version and is available nationwide. This next generation version of the INSORB|25 Stapler features a 25% stronger absorbable staple and a significantly easier-to-use technique. A single clinician can quickly close an entire incision with the INSORB Stapler and a single standard Adson forceps. To date, multiple patents have been issued and more than 500,000 staplers have been shipped since its introduction. Incisive Surgical is the only company in the world that offers a mechanical stapler that deploys absorbable staples that are placed underneath the skin to close incisions.

Sabic Innovative Plastics
Pittsfield, MA
sabic-ip.com

Incisive Surgical
Plymouth, MN
insorb.com