Bolton Medical approached Kaleidoscope Innovation to develop the medical device design for an implant introducer.

Requirements:

• Make it easy to accurately position and hold in place during deployment which required 50 pounds of force
• Create a novel method to reduce the user force requirements and improve usability
• Keep the design aesthetics and interaction as reminiscent of the current device as possible

During a joint facilitated workshop session, Kaleidoscope Innovation discovered that the high force was only required for the initial part of the medical device deployment. Kaleidoscope Innovation created a revolutionary gear-driven system with a clutch which required a small and familiar force similar to using a screwdriver to deploy using:

• Brainstorming
• 3D CAD modeling & concept development
• Mechanism & product design
• Prototyping using both 3D printing and machining
• Ergonomic & user testing

The team then came up with a dual mechanism concept. For the initial high-force phase, a rotary mechanism is used where the handle turns engage a gearing system. This provides a high mechanical advantage to deploy the stent. After this initial phase is complete and the deployment force requirements drops, a button is pressed to disengage the rotary system and engage a linear system. This enables rapid positioning of the remainder of the medical implant.

The redesigned medical device deployment tool makes it possible for surgeons of varying strength levels to deploy it while holding it accurately.

The redesigned medical device introducer:

• Provides a first-ever rotating deployment and clutch mechanism
• Reduces required force significantly and exceeds requirements by 25%
• Improves ergonomics and usability
• Increases control which enhances patient safety
• Allows surgeons of all strength levels to more accurately and confidently use the tool

Kaleidoscope Innovation provided manufacture ready designs and continued support through manufacturing tooling.