Customer Situation
A high-profile startup company engaged VitalPath to help redesign and develop its flagship product, a large-lumen aspiration catheter used to remove blood clots in patients with acute ischemic stroke.
This application requires the catheter to track though a tortuous anatomy into the M1 region of the brain where the blood clot is located so it can be removed via aspiration. The customer’s current catheter design showed poor trackability and was unable to navigate into this region.
The catheter’s inner lumen tended to ovalize during tight bends, compromising lumen integrity and frequently leading to the catheter kinking at the distal end. The customer had already gone through multiple development efforts with two contract catheter manufacturers without success, and came to VitalPath as a “last resort.”
VitalPath Solution
VitalPath’s engineering team met with the customer’s design team to clarify design issues and understand the scope of the project. VitalPath team members evaluated the performance of the current catheter design by running samples through a bench test model. After further testing and evaluation, the team identified several issues:
- The catheter reinforcement lacked radial strength, which led to ovalizing and kinking issues
- The polymer jacket transition zones were abrupt, creating weak points where kinking could occur as the catheter traversed through tight bends
- The jacket material was too rigid and compromised catheter trackability
The VitalPath team re-engineered the polymer jacket materials to create additional smooth transition zones and eliminate any points of weakness or abrupt transitions along the catheter. The team applied soft polymer materials at the distal end to enable the catheter to navigate through tight bends in the model. A nitinol wire coil added reinforcement to maintain lumen integrity and flexibility and to prevent kinking. Applying braid reinforcement improved the catheter’s torque response and pushability.
The VitalPath team became an extension of the customer’s engineering team, working together to bench test the prototypes. This allowed for real-time discussion, quick decision-making, and rapid design iterations.
Outcome
Implementing these design changes resulted in the catheter’s ability to track into the M1 region to reach the blood clot area. The VitalPath team completed these development efforts within a timeline of three weeks.
The team validated the manufacturing process and built a manufacturing line using Lean principles to meet the customer’s production needs. VitalPath’s expertise in flexible, high-mix manufacturing was a good fit for this customer and the team was able to quickly ramp up to production levels. The customer also worked with VitalPath to develop and manufacture smaller sizes of this aspiration catheter.
This premium product was integral to the customer’s later being acquired by a global medical device OEM. It also established VitalPath’s reputation in the neurovascular market as the go-to partner with the technical know-how to build complex catheters that others can’t.
About VitalPath
VitalPath comprises the companies formerly known as Catheter & Medical Design LLC (CMD); VitalDyne Medical Inc., which CMD acquired in March 2021; and Modern Catheter Technologies, acquired in January 2022. Headquartered in the Minneapolis area, VitalPath is ISO 13485:2016 certified and has an FDA-registered facility.
