One important consideration to take into account while designing and testing medical devices is how they’re going to be used.In the case of vascular devices,they will be used in arteries and veins.Before performing your verification testing, you need a reasonable clinical model to perform testing under.
For example you might have a device that is intended to be used in the Right Coronary Artery (RCA) as shown below (image from Wikipedia):
How do you ensure your device works correctly without using it on a person? You need to find an appropriate model. It is best to ensure you pick a model based on the vessel characteristics that your device will likely see (such as vessel diameter and tortuosity).
A 2-dimension model is easy to construct, but you may get into trouble if you’re using a 2D model to test a guide catheter and push it into the smallest vessels when it is only intended to sit in the aortic arch. As 2D model stresses only those two dimensions, it obviously lacks some realism as it is possible that your device will need to turn multiple planes during use.So adding the third dimensions allows additional flexibility in most devices as they are generally concentric.
Tell us what the tightest radius your device is likely to see in-vivo or send a CT and MRI scanning data of patients to us,then we will 3d print an accurate vessel model using special silicone formulas.Our model below shows an example tortuous pathway in some of their coronary block model simulated use testing:
The picture below is an example coronary artery model from Trandomed.The vessel is full of red tint to mimic the blood for easy observation.Surely you can further simulate clinical conditions, either by flowing 37C saline through the model,or a mixture of glycerin and water to simulate blood flow.
Now you can run whatever tests you can using the model.For example, a guide wire or catheter test,you can just put the device through the model,and while the device is still in the model, hold the distal end then turn the device until it breaks.The addition of the model adds a bit of complexity to the test, but is a better test system.
Models of various anatomies are available from Trandomed, feel free to contact us at firstname.lastname@example.org !