The Medical Device Production Transfer Process
A production transfer is a common occurrence in the medical device industry. However, what often...
Sensor technology is at the forefront of minimally invasive diagnostics. The effectiveness of using sensor tipped catheters is their ability to be steered through the blood vessels to the site of imaging. There are varying levels of sensitivity associated with steering the catheter. Greater precision means better medical outcomes: patients will not experience discomfort and the imaging will be error-free. The precision with steerable sensory catheters, therefore, depends on two factors, viz. the physician’s ability and the design of the sensory catheter. As medical device manufacturers and contract manufacturers, our focus rests on the design of the sensory catheter.
Steerable catheters have many parts, such as a sheath, reinforced tubing and guide wires. Choice of materials used will determine the ease of use and important catheter features such as:
To begin with, the tubing has to be engineered meticulously. Braided wiring is used to reinforce the tubing in some cases. The catheter design depends on its usage and target site to be examined. Some catheters may require a deflectable tip, single or multi-lumens etc. in order to capture precise images of the target site.
The process by which the tubing is manufactured is called ‘Extrusion’. It is a process by which a polymer base is subjected to heat and poured into a die. It is then extruded through one or more perforations to obtain the required shape and dimensions of the tube. Although it sounds like a simple process, the extruded tube has the tendency to expand and deviate from its intended dimensions. The heated polymer can also retain residual stresses which may cause kinking or hinder lubricity during use.
This is why experienced materials scientists and a team of production engineers need to work on developing an optimum mix of polymer components in order to obtain the exact dimensional requirements and structural characteristics of a catheter tube.
A manufacturer must have the capability to design electronic parts, including integrated circuits. A production technology that has the ability to automate micro-assembly is an immense value add to the manufacturer. The sensors loaded on the catheter tip must be protected or shielded from other materials. Some metals or alloys used in the production of the catheter can interfere with the sensor’s functionality. Materials such as Nitinol, Platinum, Titanium or other alloys are good options. Shape memory materials such as Nitinol, PTFE, PEEK, etc. are now widely used for their inherently inert, strong and flexible nature.
A steerable catheter may be deflectable or non-deflectable, with a lumen – single or multiple, or may not even possess a lumen. The size depends on the purpose for which the catheter is being developed. For example, cardiology or nephrology or neurology etc. Micro extrusion and assembly processes may be essential. Each has specific design considerations that are determined by specialists in the field of designing, engineering, and production. Quasar is an end-to-end contract manufacturer with over thirty-three years of experience of commitment to perfecting your steerable sensor catheter.