Stent coating system
Several steps can be completed in one with the device. The protective cap is removed from the stent with the operation of the lever, and at the same time, the drug is applied and dried with sterile oxygen.
On behalf of the customer, seleon realised the development, production and servicing of the Stent Coating Machine. Numerous technical challenges were associated with this task. For example, a solution was found for the sterile fixation of the stent in the coating machine. Another important requirement was to design the cartridge in which the stent is coated as a low-cost disposable plastic component. User ergonomics, reliability and easy cleaning were other essential considerations that had to be taken into account.
The design, electronics, automation engineering and spraying technology implemented by seleon meet the requirements described above. This is realised through an elegant mechanical coupling of a linear, one-dimensional movement with the ejection of a syringe containing the coating substance. The medication dosage accuracy is guaranteed to a fraction of a millilitre, with homogeneous coating of the stent. Fault detection and the control of the coating process are realised with sophisticated sensor technology and the firmware. seleon designed the device to differentiate between hardware and operating errors, and to exclude incorrect coating. Clinical results from the German Heart Centre Munich prove the outstanding functioning of the machine in everyday use, confirming that it will constitute an important tool for cardiologists in the growing market for coronary stents.
The handling of quality assurance and service by seleon and the international deployment show that development and production from one source promises success.