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Product Innovation

Efficient lithotripsy in the smallest of spaces

An operational system to remove urinary stones was to be miniaturized. Zühlke integrated all the functions required into a battery-powered handheld device.

Customer Benefits

  • Innovative solutions for integrating functions in a highly confined space.
  • Rapid compliance with regulatory requirements thanks to experience in medical technology.
  • Verification of critical functions at a very early stage.
  • Minimal production costs.

Task

In lithotripsy, urinary stones are destroyed with shock waves and subsequently removed. Today’s surgical instruments consist of application components that are connected to an external power supply and control units via cable or tubing. Compact versions are also available on the market, but they only release individual pulses. EMS wanted to develop a miniaturized system: Operations were to be carried out with a wireless handheld device that generates continuous shock waves.

Solution

The team developed an efficient, compact drive system with a multi-stage transmission. For the prototype series, Zühlke minimized the weight and consistently took the user’s requirements in a sterile environment into account. This helped ensure optimal usability. In cooperation with the client, the prototype series was subjected to a range of different tests. The development was carried out in accordance with the customer’s development process. This was subject to the Design Control requirements of the European Medical Device Directive 93/42/EEC and FDA Quality System Regulation (21 CFR 820).

 

Photo: Mr Thorsten Knauf

Thorsten Knauf

Director Business Development
Medtech