At Arrotek, we have significant experience in catheter design, particularly in the development of advanced catheter technologies. This includes atraumatic catheters with ultra-thin walls as low as 0.1mm (0.004″). The projects we regularly work on involve the development of catheters with intended usage applications that require the ability to navigate small and complex vasculatures to access difficult to reach parts of the body, such as in high-risk neuro and coronary interventions.
We also have experience in the design of large-bore catheters, including multi-functional devices, that deliver high levels of performance. Examples include catheters designed for the delivery of innovative therapies or catheters for structural heart access.
Delivering on Your Objectives
We’ll use our extensive experience and broad range of knowledge of catheter design to successfully take your idea for a new medical device from concept stage through to final prototype. We also have contract manufacturing capabilities in-house, so we can provide additional expertise and services as you begin to commercialise your new medical device product.
In terms of the catheter design process, we are innovative thinkers with a proven track record of developing new solutions to complex design challenges. We have in-depth knowledge of the various materials that are available. as well as a high level of understanding of clinical requirements and demands.
Catheter Design Capabilities Overview
- Ultra-thin-walled catheters
- Reinforced catheters
- Stent, valve, and implant delivery systems and introducers
- Balloon occlusion catheters
- Steerable shafts
- Catheter devices with integrated sensors
- Electrophysiology catheters
- Ablation catheters
- Aspiration catheters
- Guide catheters
- Support catheters
Applications and Fields of Catheter Expertise
Cardio-Vascular
At Arrotek, we have a wide range of catheter design capabilities suitable for minimally invasive applications. This includes:
- Aortic, mitral, and tricuspid valve delivery and replacement systems
- Other delivery systems, including AAA endoprosthesis and coronary bifurcation stents
- Rapid exchange and over-the-wire delivery systems
- Access sheaths
- Steerable shafts, including applications that require high tensile loads
- Braid and/or coil reinforced catheters
- Telescopic devices
- Diagnostic catheters
- Devices for applications that involve mechanical circulatory support or extracorporeal support for the heart or lungs
- PFO closure catheters
- Vascular sealant applicators
Peripheral Vascular
Our peripheral vascular catheter design capabilities include:
- AAA endoprosthesis delivery systems
- TAA stent graft delivery systems
- EVAR stent graft delivery systems
- Multi-functional devices
- Occlusion catheters
- Ultra-thin-walled catheters
- Reinforced catheters
Neurovascular
Neurology is one of the most exciting areas of advanced catheter technologies, with new innovations constantly pushing the limits of medical boundaries. Arrotek has experience at the cutting edge of these developments. Our expertise includes:
- Catheter devices with the lowest possible profiles and ultra-thin walls
- Braid and/or coil reinforced catheters using ultra-fine wires
- Microcatheter access devices
- Neurovascular guiding catheters
- Delivery systems for stent, embolic, and coil applications
- Balloon occlusion catheters
- Clot, thrombus, and filter retrieval systems
- Integrated devices
Gastrointestinal
Our gastrointestinal catheter and minimally invasive medical device design capabilities include:
- Catheter devices with long shafts
- Reinforced catheters
- Steerable catheters
- Endoscopic suturing systems
- Implant delivery systems, including wireless implants
ENT
Our ENT catheter and endoscopic device design capabilities include:
- ENT navigation systems
- Bronchoscopes and other bronchial applications
- Artificial larynx delivery systems and other laryngeal applications
- Oesophageal stent delivery and other oesophageal applications
Emerging Technologies
Our design engineers constantly push the boundaries of advanced catheter technologies to improve patient outcomes in a range of fields and applications. As a result, we can integrate these new and emerging technologies into your new catheter device. Our knowledge areas include:
- Embedded devices
- Smart catheter technologies
- Catheters with integrated sensors
- Electrodes
- Fibre optics
- Wireless technologies
Tubing
At Arrotek, we have extensive expertise in developing innovative tubing solutions for novel catheter devices. Our engineers have experience in the design of tubing with a range of outer and inner diameters, as well as various wall thicknesses and lengths.
Over recent years, we have become an industry-leading specialist in the design of ultra-thin-walled tubing.
Our expertise also includes reinforced tubing, coextruded tubing, multi-lumen tubing, micro-extruded tubing, peel-away tubing, and sheathing.
Reinforced Tubing
We have braid and coil reinforcement capabilities in our state-of-the-art facility, in addition to extensive knowledge of these technologies. We also have extensive materials knowledge for use as tubing reinforcement.
When going through the catheter design process, our engineers will develop reinforced tubing to match the performance requirements of your new device. This could be through the use of braid reinforcement, coil reinforcement, or a combination of both.
Even within these broad categories of reinforcement methods, there are variations that can enhance specific performance requirements. In a coil reinforced tube, for example, those potential variations can include:
- Flat or round coil profiles
- Various material options, including nitinol, fabric, stainless steel, and more
- Closed coil and open coil
- Variable pitch coil reinforcement
- Smooth tapered transitions
- Left or right-handed coiling
- Compression coils
- Coil over coil reinforcement
- Coil over braid
- Welded coil termination
- And more
In general, some of the performance improvements that can be achieved with reinforced tubing (depending on the methods used) include:
- Kink prevention
- Improved crush resistance
- Improved torque control and torque transmission
- Improved under pressure performance
- Compression resistance
Materials
During the catheter design process, our engineers will consider a range of factors when looking at the best materials for your new medical device idea. This includes:
- The physical and performance requirements of the device
- Biocompatibility
- Sterilisation considerations
- Processing considerations, including methods and any limitations
- Chemical characteristics
- Shelf-life stability
Our materials knowledge and expertise include:
- Tubing – PEBAX, TPE, EVA, HDPE, LDPE, TPU, polyimide, and silicone rubber.
- Liners – PTFE, polyethylene, FEP, and hydrophilic coatings.
- Reinforcement – nitinol, stainless steel, PEEK, PET, nylon, and aramid.
- Balloons – PEBAX, polyurethane, nylon, silicone, PET, and TPE.
- Handles and Luers – polycarbonate, polycarbonate-ABS, ABS, polypropylene, nylon, PEI, and PETG.
Other Materials
We also have knowledge and experience with other materials required for specific applications such as implants, radiopacity, and other unique performance characteristics. Those additional materials include ePTFE, barium sulphate, polysulfone, cobalt-chromium, silver chloride, gold, PMMA, platinum-iridium, tungsten, hydrogel, nanoparticles, and foam.
Components
In most catheter design projects, a significant proportion of time is spent on crucial elements, such as the shaft or tubing. However, there is a range of other components, secondary operations, and parts that are also important in the development of new catheter devices.
At Arrotek, we have sub-assembly capabilities in our modern facility, so we can bring broad expertise to your project. This is in addition to the knowledge and experience of our design engineers. That knowledge and experience include:
Handle Design
We design ergonomic handles that provide users with high-precision control over the direction and orientation of the catheter tip. Our expertise includes push/pull steering handles, levered steering handles, rotating wheel steering handles, and more.
Injectors
Our expertise includes contrast media injectors, syringeless injection systems, contrast delivery injectors, power injectors, and more.
Peelable Hubs
Peelable hubs and cannulas, as well as peelable sheaths with replaceable hub connectors and easy to remove peelable introducers. We design peelable components to ensure the peeling process is smooth and even.
Y-Connectors
Our expertise in the design of y-connectors for catheter devices includes y-connectors that offer fast flow rates, greater control, and improved patient comfort. The options include two-way, four-way, barbed, luer, and more.
Tips and Caps
We can design a range of tip types (split tips, shotgun tips, step tips, etc.) to deliver the performance characteristics that your device needs, from tip stability to catheter function and more.
Packaging
Our catheter device packaging expertise includes a range of packaging design options to protect the catheter and create a sterile barrier. We have EU MDR and FDA regulations expertise, so we’ll ensure the labelling of your catheter device meets the requirements of regulators while also offering commercial benefits.
We’ll also ensure the cost of packaging is optimised during the design process by minimising the materials and labour required to package your product.
Technologies, Processes, & Equipment
Design for Manufacture
Design for manufacture (DfM) and design for assembly (DfA) considerations ensure the catheter design process stays aligned with your commercialisation goals. In other words, both processes are about ensuring your new device can be manufactured according to specification and within cost targets. The aim is to make the device as cost-effective to manufacture as possible without impacting safety, performance, or efficacy.
Prototyping Capabilities
We have a broad range of prototyping capabilities at Arrotek. This enables us to keep the production of prototypes in-house, improving the design process, making the process more efficient, and protecting your IP. The prototyping capabilities in our state-of-the-art facility in Sligo, Ireland, include 3D printing, injection moulding, laser welding, balloon blowing, and more.
As part of our medical device design process, we produce both stage 1 prototypes and stage 2 prototypes.
Stage 1 prototypes are crucial to the design process and are produced using initial design drawings. This is often the first time that a physical representation of the product is created.
Stage 2 prototypes are produced at the end of the design process and are typically produced in small batches for further evaluation and testing, including clinical testing.
Human Factors Design
Human factors design, or human factors engineering, involves designing your new medical device to reduce the potential for users to make a mistake while at the same time maximising its effectiveness.
Our team at Arrotek has extensive experience in human factors design, including assessing human behaviour, user limitations, user abilities, etc.
Manufacturing Capabilities
- Balloon blowing
- Tipping
- Laser welding
- injection moulding
- Bonding
- 3D printing
- Film welding
Sub-Assembly and Related Services
- Tray sealing
- Pouch sealing
- Bonding, forming, and other sub-assembly processes
- Full packaging services
- Sterilisation coordination
- Logistics
Cleanrooms
We have multiple cleanroom facilities in our main manufacturing centres in Sligo, Ireland, and North Attleboro, USA.
Testing Capabilities
- Testing to various recognised standards, including ISO, EN, ASTM, and DIN
- Testing according to regulatory standards and guidelines, including those set by the FDA and EU MDR
- Performance testing, including torque-ability, lubricity, trackability, etc.
- Usability testing
- Design, process, and sterilisation testing
- Age and transportation testing
- Usage instructions clinical language verification
Regulatory Expertise
- FDA approval support through 510(k) submissions and other processes
- CE marking support, including extensive knowledge of EU MDR
- ISO certified quality management systems
- Clinical trial support
The Expertise You Need
As a forward-thinking and ambitious company, our capabilities at Arrotek are constantly evolving as new technologies become available and new innovations are developed. We also continuously push the boundaries of development internally, breaking new ground and opening up new areas of possibility.
Whatever idea you have for a new medical device, we are the team who can take it to the next stage, helping you make your vision a reality. Get in touch with us at Arrotek today.
