Catheter manufacturers, compared to most other industries, face a somewhat different set of challenges. There are three main factors responsible for this; the high level of detail required, strictly enforced regulatory frameworks, and the unique challenges faced whenever a new device is introduced for manufacturing. It is therefore of paramount importance for catheter manufacturers to implement technologies, in their effort to remain efficient and competitive.
In this article we take a look at the applications and technologies that medical device manufacturers use today, to meet the demanding conditions of catheter manufacturing.
Minimally invasive devices can range from simplistic designs, to very finely detailed mechanisms. Consider the difference between a simple plastic tube urinary catheter, compared to a minimally invasive surgical device, like a therapeutic catheter.
The latter can include a number of moving parts with complex geometry and functionality. For such detailed tasks, catheter manufacturers operate specialized micro assembly production lines. In these lines, highly skilled and trained operators assemble parts under a microscope using specialized tools. This enables precise fabrication of detailed parts, in a reliable and controllable manner.
Catheters are used in a gamut of applications; from guide and delivery to therapeutic operations. Catheter functionality is often augmented by using sensors, screens, and data recorders among other electronics. These are traditionally housed in a separate control panel, where the catheter connects to, in order to operate.
A technological trend used by catheter manufacturers today is the use of embedded electronics. These systems operate in place of the bulky remote control panels of older catheter designs, without of course sacrificing the device’s safety, usability and efficiency. This way the catheter’s operation can be made simpler, more energy-efficient and straightforward, while reducing the device’s overall weight and increasing its portability.
Nitinol is a biocompatible metal alloy with extraordinary attributes. Apart from its exotic property of shape memory deformation, it also exhibits high fatigue tolerance, flexibility, and superelasticity. The fact that its first commercial application dated more than a decade after its discovery is a testament to how challenging it is to use. However, due to its unique features, there is nowadays a high demand for Nitinol used in minimally invasive medical devices, implants, and catheters.
Expert catheter manufacturers make sophisticated use of Nitinol, for manufacturing specialized medical devices. Common applications include Nitinol tubing and superelastic needles. In advanced catheter applications with improved effectiveness and safety features for the patient. Moreover, the material is used in custom shapes for collapsible medical device structures, either molded or made from thin Nitinol braided wire.
Catheter manufacturers have made some amazing advances in the area of Sensors. These tiny components add immense value to minimally invasive procedures by guiding or aiding navigation of the catheter through blood vessels, detecting body temperature, surrounding pressure, detecting the presence or absence of obstructions, building 3D, real-time images of the area through which the catheter progresses.
Traditionally, any kind of surgical procedure involved a certain degree of assumption. For example: the surgeon based his actions on pre-surgery imaging and sometimes on real-time fluoroscopic imagery to determine whether he has arrived at the site of a blood clot or a blockage and can thus remove it. With advanced micro-sensors embedded in the walls or the tips of catheters, these tiny sensors are revolutionizing the field of minimally invasive surgery, acting as the eyes and ears of the surgeon.
Advanced knowledge and proven catheter sensor manufacturing experience is not easily found in the industry. Manufacturers known for producing high performing sensors have a limited offering of off the shelf pre-made products. It is even rarer to find a manufacturer that can offer sensor manufacturing as part of a turnkey solution with the manufacture and assembly of the remaining components of the complete device.
A catheter manufacturer should have the know-how to identify potential manufacturing issues, and the infrastructure to assess and implement the best solutions. With more than 30 years of experience and fully equipped manufacturing facilities, the team at Quasar utilizes the latest technologies and applications used in catheter manufacturing.
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