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Background

Abbott Vascular, a global leader in cardiac and vascular care, realized a need to redesign their disposable, hand-held stent delivery system.  The stent delivery system which increases the opening of the arteries primarily consists of the stent, a tube that is inserted into the body and the sheath which encases the stent.  The device included a deployment lock and one Luer fitting that fed separate fluid paths within the catheter set.  The design at the time featured a stent that required a significant amount of force to deploy.  Speck Design was tasked with redesigning the handle of the delivery system to be articulated with easy, low-force operation.

Challenge

Abbott Vascular wanted a stent delivery system with smooth and precise action, ergonomics and an intuitive user interface all while considering manufacturability.  Additionally, the new design had to incorporate a unique internal mechanism and accommodate significantly large stents of up to 160mm in length.

Solution

Through a series of brainstorms we explored possible system architectures and user-interface considerations for the handle.  We presented hand-crafted models and mechanism breadboards early in the process, encouraging feedback on ergonomics and actuation.  From the models, Speck Design made further refinements to the functional mechanical design incorporating features specific to the manufacturing process. 

One of the primary considerations was the extreme force of deployment for such a long stent.  A significant amount of FEA structural analysis was preformed, because the hand held device is small, yet the doctors are applying approximately 10 pounds of force to the device during initial stages of deployment.  The longer the stent, the more force was required to deploy the sheath.  The larger dial on the device allows a user to apply greater mechanical advantage during the initial seating of the stent on the arterial wall.  Once the stent is in place, and a low amount of force is applied to the sheath, the surgeon can opt to use the slider to expedite the rest of the procedure.  When the device is articulated through the dial or the slider, a belt mechanism will actuate the stent at the distal end of the device.

Results

The final design was modified so that the handle mechanism could be assembled as a separate sub-component within the handle's encasing.  This allowed Abbott Vascular to first assemble the complicated internal mechanics and then install them into the housing.  Speck Design addressed the issue of extreme force of deployment, ergonomics to create a handle that allowed for the delivery of the largest stent in the industry at the time.

PROJECT INFO

• Client:

  Abbott Vascular

• Project:

  Stent Delivery System

• Industry:

  Medical