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Valvulotome for Vascular Surgery

Highly controllable catheter-based instrument

The Valvulotome® is a catheter-based surgical device for cutting and disabling venous valves. It is used by vascular surgeons to perform an in-situ bypass of the lower extremity arteries with existing veins.

The Challenge

The client wanted to evolve an early stage prototype of the device into a more controllable and manufacturable product. The cutter head design had to meet strict user requirements for operating the controller and to address safety issues.

How StarFish Helped

  • Design of cutter head, including miniature stainless steel assemblies for self-sized guide fins and cutter blades with mechanical cross-linkage
  • Mechanical design of cutter head adjustable to changing vein diameter along full length of a patient’s leg
  • Safe cutter head housing without exposed blades

The Results

  • Conceptual development and prototyping
  • Detail design under ISO 13485
  • Manufacturing transfer to external partner
  • Substantial improvement and change of direction from initial prototype creating new IP for client

Client: Koven Technology

Tags: laser machining surgical device vascular

I commend you for your vision in looking well ahead to regulatory and contract assembly issues, as well as a decision to develop key prototypes concurrently that ultimately led to a successful design concept. All initial design requirements were satisfied.

You also showed an incredible depth of knowledge and expertise with regards to design for manufacturability.

Ian Maclean
Project Manager
Koven Technology Canada Inc.

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