Carbon Design Group

A.M. Surgical Stratos

A.M. Surgical - Side View - Carbon Design Group

Enabling surgical expertise. As an innovative, all-in-one surgical device for endoscopic carpal tunnel release, Stratos™ delivers an ingeniously simple user interaction as it empowers surgeons to restore patient dexterity, allowing for swift return to work and play.

Advancing the State of the Art

A.M. Surgical - The Stratos - Illustrated View

A revolutionary tool leveraging a groundbreaking cannula.

Carpal tunnel syndrome affects millions. In this painful and often debilitating condition, the median nerve is compressed in the narrow canal between the bones of the wrist and the ligament at the base of the palm. Surgeons treat carpal tunnel syndrome by dividing this ligament to relieve pressure on the nerve.

A.M. Surgical advanced this procedure with the Clear Cannula, which allows a clear view of the surgical field while protecting structures including the median nerve. The A.M. Surgical scope-mounted blade further optimized the treatment.

Despite these advancements, the procedure as a whole was still cumbersome. Introducing the cannula required using a secondary tool to advance it into the carpal tunnel. This was done blindly and at times would require multiple attempts to correctly position the cannula within the tunnel. Furthermore, application of the scope-mounting blade onto the scope required the assistance of OR staff leading to increased steps and inefficiencies.

Solving these problems would create a faster, safer, and more effective surgery.

Process Makes Perfection

A.M. Surgical - The Stratos - Prototype Testing

A.M. Surgical - The Stratos - on-the-fly prototype modifications

A.M. Surgical - The Stratos - Prototype Evolution

“What impressed me about Carbon was their openness to the creative process in order to drive innovation,” said Romi Mirza, President of A.M. Surgical. ”They were not held back by supposed design limitations. Instead they tackled each of our internal parameters with the thinking that it can be done while keeping sourcing, manufacturing and assembly considerations in check.”

A.M. Surgical’s expertise was invaluable to the development process. Concepts were prototyped and quickly tested. For some tests, surgeons were observed. For others, we gained first-hand knowledge by working alongside the A.M. Surgical team conducting cadaver studies.

This iterative approach enabled the team to quickly hone in on solutions, even making and testing modifications mid-procedure.

CLOCKWISE FROM TOP LEFT: prototype testing on cadavers; making modifications on-the-fly; nearly 20 different prototypes in all.

The Details are the Magic

A.M. Surgical - The Stratos - Blade Side View - Carbon

The elevated tip of the cannula is the primary tool for preparing the underside of the ligament.

A.M. Surgical - The Stratos - Button Detail

The button on the rear portion allows surgeons to couple and decouple the scope with ease.

A.M. Surgical - The Stratos - Revolver Detail - Carbon

The paddle lets surgeons switch quickly between scope, scraper, and blade without taking their hand off the device.

The final product met its goals and exceeded expectations. Stratos is an all-in-one device that includes the clear cannula and a handle that provides increased leverage and keeps the scraper and blade poised for deployment. This configuration greatly reduces the number of steps in the surgery and increases efficacy.

A key innovation in the procedure is that once the Stratos cannula is introduced into the patient, the Stratos/endoscope combination never leaves the body. This keeps the cannula in the optimal position at all times. A paddle switch on the front section of the handle can be in one of three positions, Scraper, Scope, or  Blade. To change tools, the surgeon pulls the endoscope back, and flips the switch. The selected tool is deployed and the surgeon maintains a clear view while advancing the endoscope to scrape, cut, or view the ligament. The tool is automatically returned to the revolver when the endoscope is pulled back again. From insertion to exit, the surgeon has complete vision of the surgical field at all times.

Brand Appropriate

A.M. Surgical - The Stratos - Front Three Quarter - Carbon Design Group

The A.M. Surgical team is determined to push the status quo and deliver innovative tools that make even the best hand surgeons better. Traditional medical design, which tends to be soft and subdued, wouldn’t fit this forward-leaning brand. Just as a doctor’s sports car delivers performance and confidence, the purposeful design of Stratos gives doctors confidence and enables them to perform at their highest ability.

Stratos helps set the tone for future A.M. Surgical products with details that increase performance and inform use. The incorporated fulcrum on the front edge of the handle provides leverage when introducing the cannula. Form and material guide the surgeon to during use. High polish touch points and purposeful forms work together to make an intuitive product.

The interactions and mechanisms were developed simultaneously, resulting in a design naturally optimized for both manufacturing and assembly. The individual parts are engineered to be efficient, resulting in production costs that make the device a profitable addition to the A.M. Surgical line.

The Stratos is an impressive, all-in-one disposable medical device that streamlines carpal tunnel release surgery, making the procedure faster and easier to master.

Carbon’s forward thinking has helped us gain a competitive edge in the hand surgery market, and we’re already seeing dividends.

Romi Mirza
President, A.M. Surgical

Contributions
  • Industrial Design
  • Mechanical Engineering
  • Research
  • User Interaction
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