Catheters often need to navigate through complex anatomy in order to reach the desired location and perform their specific task. From neurovascular to structural heart and peripheral vascular application needs, there can be big differences in the catheter requirements.
Therefore, maintaining precise control of the catheter is critical. In this blog our experts have outlined the key elements to consider, and tips to guide you through the steps of designing your steerable catheter.
How to begin designing your steerable catheter.
Everything starts with your idea for your product and how its therapeutic or diagnostic function will work. You should then ask how that functionality will be delivered within the body.
If you decide you need a catheter with steer functionality for fine control of access and placement then the first question you should consider is:
What characteristics does the catheter need to possess and/or what are the tasks it needs to carry out inside the body?
- Access diameter and profile which will be dictated by your vessel diameter and the other access sheaths and catheters your catheter will work in tandem with.
- Shaft Flexibility. Super flexible to Super stiff. Proximal and distal end unique requirements to suit your specific anatomical challenges.
- Steering requirements for your shaft:
– 1 way, 2 way or more!
– Multiple steering points and multi plane steering, common in structural heart access and delivery systems to include multiple deflection points and which can steer in different planes.
– Steering length – length of shaft that will be deflectable – the length of deflection should be allowable in the space it will steer.
– Steering curve diameter – the geometry of your deflected shaft requirements.
– Steering angle – what steering deflection angle will be required? 90o 180o 270o Understand your ‘must-haves’ vs your ‘nice-to haves’. It can be wasted effort designing for 180o deflection when you only need 90o.
– Steering force – how strong do your steering wires and steering mechanism need to be? Are you deflecting with high force loads?
- Radiopacity requirements or other catheter shaft markings; RO marker bank for catheter tip, RO loading of entire shaft, printed marker bands for shaft insertion?
- Tensile and compression performance for your shaft; Will there be high compression, tensile or radial forces on the shaft during use?
- Handle interface with the shaft; Preferred actuation mechanism and requirements of shaft / pull wires to interact with your preferred handle mechanism.
- Catheter shaft working length.
- Guidewire compatibility; 0.035”, 0.014”, 0.018” guidewire compatibility.
These are just some of the many considerations that we at ICS Medical Devices will look at when designing and developing steerable catheters for our clients.
Our focus is always on achieving an efficient, streamlined development process, to accelerate your next generation product to market.
Contact us today If you are looking for an experienced team to guide you through the steps of designing your next generation device.