Advanced Catheter Extrusions
In combination with many years of expertise in tubing and catheter manufacturing, Freudenberg Medical continuously invests in the latest process technologies.
This ensures that our capabilities remain best in class to meet the challenging needs of the healthcare industry.
Extrusion, a Central Process in Catheter Development
The extrusion and catheter finishing processes are inextricably linked and balancing these processes can be a complex undertaking
There are a number of variables that can ultimately affect the performance of a finished catheter, the most paramount are the properties of the raw material and the extrusion process. Careful consideration of the extrusion process is essential to ensure consistency and repeatability. Including extrusion engineers in the development decision making process is integral and collaborative communication between customer and supplier will enhance concept development and ultimately get devices to market faster. It is important to keep in mind that there is far more to tubing than dimensions. Establishing a "see it, say it, fix it together" culture is key to getting a tube from concept to production.
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Control Inputs & Outputs
The manufacture of high quality extrusions used in sophisticated catheter systems is greatly affected by tight control of the "inputs". Initially, the inputs start with people, because people can influence the other inputs like training, material handling, storage conditions, control of drying and equipment, tooling design, and so on. So, having the right mix of people is a good starting point. The greater the control of inputs to the extrusion process the higher the probability of achieving the desired output necessary to develop and manufacture high quality extrusions. "Outputs" begin with process stability, and then the spotlight turns to achieving the agreed upon customer specifications, such as critical dimensions, visual criteria, and functional performance. The tolerance expectations from customers are constantly challenging the boundaries of extrusion capability. It has become more significant than ever for tubing manufacturers to maintain close control of their inputs and process.
Polymer Science & Material Behavior
A good understanding of polymer science and material behavior is undeniably crucial for producing high-quality catheters and balloons. The morphological structure of the thermoplastic material can change with varying thermal conditions which, in turn, determines key physical properties such as strength and flexibility. The polymer exits the die head of an extruder in an amorphous state and the rate and length of the cooling downstream from an extruder controls the degree of crystallinity in the final product.
In some medical applications, such as balloon forming, it is critical that the extruded tubing is amorphous prior to the balloon forming process. Therefore, the cooling parameters and cooling method used are critical to ensure that crystallization does not occur in the tube during the extrusion process. In other applications, such as the extrusion of PEEK tubing, it is critical that the PEEK tubing achieves a relatively high level of crystallinity during extrusion to ensure that the tubing utilizes the outstanding properties that PEEK possesses.
To produce high quality balloons and catheter systems, it is fundamental to have all the extrusion inputs under control. A capable process with high quality melt is critical to produce tubing for consistent balloon quality and desired performance. Additionally, a sophisticated extrusion process with precise in-line monitoring and control is also crucial to achieve high quality balloon tubing. Small process variations can undoubtedly hinder the quality and performance of the final product. These variations potentially impact melt homogeneity and can result in variability in balloon tubing performance.
High Pressure Tubing
Freudenberg Medical has developed an innovative solution which enables customers to create medical devices that improve clinical outcomes. In addition to several other applications – this product may be used for the transmission of contrast media (under high pressure) throughout the vascular system.
- Polyurethane tubing reinforced with polymer monofilament
- Burst pressure exceeding 1800psi
- Custom sizes available
- Constant working pressure of 1200psi
- High Flexibility
- High Clarity
- Outstanding decay properties
- Can be sterilized with ETO
- Available on spools or cut length
Tubing can be supplied as finished tubing assemblies with UV solvent bonded connectors, if required.
Mutli-Lumen Tubing
Working with you to meet your Requirements
Freudenberg Medical will work with you to develop and produce configured multi-lumen tubing to meet your specific requirements such as lumen geometry, material and lumen rating . All extrusion tools required are designed in-house by our core design team. Our multi-lumen tubing is often used in demanding applications such as minimally invasive surgery where lumens allow multiple functions or instruments to be placed within a limited space.
Our multi-lumen tubing allows you to achieve the best possible flow rates and customizable configurations are unlimited. Your final configuration will be specific to your needs, and all aspects will be kept confidential for each customer.
PEEK Tubing
PEEK tubing is well known for its resistance to extremely high pressures and in many cases has replaced stainless steel. Due to its high purity, PEEK tubing does not leech out damaging ‘extractables’ and is very effective in the trace analysis of complex fluids. PEEK tubing is compatible with high doses of radiation thus resisting embrittlement and maintaining mechanical integrity in the most demanding environments.
Key Features of PEEK Tubing:
- Ultra hard material
- Very good chemical resistance
- Stable at temperatures up to 228°C
- Excellent abrasion resistance
- Flame retardant (UL94 V-0)
- Very tight dimensional tolerances
PEEK Tubing:
- In coils, on spools or straight lengths with clean, square cuts
- Translucent or Opaque
- Wall thickness varying along length (Bumped tubing)
- Coloured PEEK tubing
- Multi-Layer PEEK tubing
- Reinforced PEEK tubing (Stainless Steel Wires)
- Shaped tubing
Tubing can be supplied as finished tubing assemblies with connectors, if required.