Creating The First Expandable Radial Sheath

Group 21: Team Ayquorn

The Problem/Need

“There is a need for delivery sheaths which can locally radially expand to accommodate delivery catheters/devices without causing changes in the overall length of the sheath."

 

Our goal is to create the first expandable radial access sheath.

While there are already expandable sheaths on the market, they are meant for femoral artery access. The radial access sheaths that do exist are not intended to expand. Some examples of current sheaths include the Terumo SoloPath sheath, Edwards eSheath, and the Boston Scientific iSleeve. Although both the Edwards and Boston Scientific sheaths are able to expand, they are only created for the femoral artery. On the other hand, the Terumo sheath is a radial access sheath that is capable of expanding one French (Fr), where 0.33 mm is equal to 1 French. Thus, we are creating the first sheath that will be able to expand up to 3 French sizes (4 - 7 Fr) within the radial artery for cardiovascular procedures. Along with this, we will be ensuring that our sheath does not drastically change in length during radial expansion as this change can result in a shift in positioning within the artery. Furthermore, we want to relieve compression along the catheter body as it is being pushed through the sheath to avoid the use of excessive force.

Our Solution

 

 

Expandable Radial Sheath

The prototype is made up of two materials that alternate between an elastic and rigid component. The elasticity allows for radial expansion while the rigidity provides structure, stability, and prevents a change in length of the sheath. The materials used for the prototype, and chosen based on elasticity, are Silicone (rigid) and Latex (elastic). The hub component consists of a cap to cover it, tubing, a stopcock to control flow of fluid, and a hemostasis valve made of silicone to minimize fluid loss. The inside of the sheath will also be coated with a hydrophilic coating such as SurgiLube to help reduce the problem with friction between the sheath and the catheter. For the final design we plan to use Pebax (elastic) and Teflon (rigid) although this has not been finalized.

Competitors

 

Terumo Pinnacle

Edwards Esheath

Terumo Solopath

Ayquorn (Ours)

French Size 4-9 14 19-24 4-7
Expandable No No Yes Yes
Radial or Femoral Radial Femoral Femoral Radial

Market

Our target audience includes interventional cardiologists/radiologists among others who may benefit from the use of a radial sheath. The expansion of the sheath also saves cost as it can expand 3 French in size.

  • Average cost of radial sheath on market: $40-50 (per sheath)
  • Current Cost of our sheath: $75-80 (3 sheath sizes in one from expansion)

Team