creganna medical proximal catheter assembly hypotube metal shaft

Proven technology for your PTCA catheter

Metal shafts and hypotube components are essential technologies for catheter shafts used in Minimally Invasive access and delivery devices. As one of the industry's premier partners for catheter metal shafts, you can depend on us for innovation, clinical performance and product quality.

>80%

More than 80% of the world's coronary stent and PTCA catheters contain hypotube technologies from Creganna Medical, part of
TE Connectivity.

Our focus? Helping medical device companies like you, improve outcomes for patients undergoing vascular interventions. At Creganna Medical, part of TE Connectivity, we operate 24/7 from our fully dedicated metal shafts & hypotube facilities, providing solutions for more than 80% of the world's coronary stent and PTCA catheters. Our expertise in hypotube design and distal transition solutions combined with our experience in materials science and advanced laser processing means we can assist you with all of your critical design decisions.

150m

150 million patients worldwide have been treated with catheters containing our metal shafts and hypotube technologies.

200+

Providing metal shafts and hypotube technology to more than 200 customers across 40 countries.

DES

Every major generation of drug-eluting stent launched to market is supported by metal shaft technologies from Creganna Medical, part of
TE Connectivity.

What is a hypotube?

And when is it used?

A hypotube is a long metal tube with micro-engineered features along its length. It is a critical component of minimally-invasive catheters, used in conjunction with balloons and stents to open up clogged arteries. The balloon portion of the catheter is attached to the distal tip of the hypotube. The hypotube enters the body and pushes the balloon along a long, tortuous and complicated vascular path towards the clogged artery. This journey requires the hypotube to resist kinking without compromising its ability to glide (attributes known as push, track and torque) through the anatomy.

Where can you find our hypotube technology?

Enabling access & delivery for Minimally Invasive devices
  • Balloon & Self Expanding Stent Delivery Systems – PTCA & PTA
  • Specialty catheters – CTO, Atherectomy, Thrombectomy
  • Embolic Protection & Filter Devices
  • Intravascular Imaging Devices
  • Neurovascular Coil Delivery – shafts diameters of <1 French
  • Advanced Endoscopic Steering Devices
creganna medical hypotube

Superb Hypotube Shaft Design

...begins with an understanding of the performance requirements for your product application.

Key Design Considerations

Metal Shafts and Hypotubes
  • Transition – Custom engineered transitions to optimize product performance using process technologies and features such as laser spiral cutting, a skive feature or corewire weld.
  • Trackability – A wide variety of coating technologies to maximize trackability including PTFE coatings and discrete polymer overjacketing.
  • Push and Torque – Optimization of these key performance characteristics ensures consistent and reliable location of the treatment site. We advise on the best design to optimize these characteristics.
  • Kink Performance – Central to the overall ability of the hypotube shaft to navigate the anatomy, we offer both design advice and the Creganna Medical PoleVault hypotube product to optimize kink performance.
  • Compression Resistance – For hypotube device shafts that must resist longitudional compression during device deployment in order to ensure exact device placement, we assist you in finding optimum shaft design. Requirements should be defined in specific terms prior to prototype development e.g. a 1,000 mm shaft must exhibit less than 1% compression where a 4lb force is applied.
  • Flexibility – Many hypotube shafts must navigate complex anatomy or tortuous paths. Flexibility requirements can be specified in terms of the bend radius that must be achieved e.g. the shaft must be capable of bending around a 30 mm diameter. We provide a range of solutions, technologies and expert guidance to achieve optimal shaft flexibility and flexibility biases.

Hypotube Design Challenge:  Design of the optimum hypotube shaft for your device delivery requires a fine balance of all the above performance characteristics. Achieving the best performance in one characteristic can often directly affect other characteristics. We're here to provide you with experience and expertise and assist you in making these critical design decisions.

Creganna Medical tube collection

Delivering the optimal hypotube requires an advanced range of technical solutions.

  1. Distal shaft technologies - The transition or finish of the distal end of the metal shaft is of vital importance to the overall metal shaft design, as it plays a pivotal role in overall clinical performance. Technology features of distal transition zones range from simple burr free cuts to more complex spiral, skive, slot, crimp, taper or flare designs. Additional features can be added to the distal transition zone such as corewires, coils or custom micro-machined components to add additional flexibility or smooth the transition to the distal assembly.
  2. Intermediate shaft design - Working with you, we can develop the optimal intermediate shaft design for your delivery device. We assist with critical design decisions relating to material choices, properties and design alternatives. Advanced laser processing techniques can dramatically transform a metal shaft to increase flexibility and torque response. Appropriate femoral, radial or brachial markers can also be applied. We also provide a range of coating solutions along the intermediate shaft from simple PTFE/FEP coatings to polymer overjackets that combine the strength of a metal shaft with the flexibility of an outer polymer jacket. Your choice of coating solutions will impact catheter shaft lubricity and overall device trackability.
  3. Proximal Shaft Design - Design choices for the proximal shaft will affect overall usability of the delivery device or catheter. The most common and simple solutions include luers or hubs which facilitate basic access to the catheter lumen for the injection of fluids or drugs or the introduction of guidewires and sheaths. These components can be combined with an appropriate strain relief mechanism and overmolded to create a finished metal catheter shaft sub-assembly. More advanced proximal designs include complex handles and deployment mechanisms that integrate mechanical, electronic or diagnostic mechanisms – all of which we can design and develop for you.
MATERIALS SPECIFICATIONS SURFACE SOLUTIONS

Medical grade stainless steel - 304, 304L, 177

 

PoleVault - Superior kink resistance

 

Javelin - Superior push

 

OD from 0.008"

 

ID from 0.005"

 

Customer specified;

- UTS

- Yield Strength

- Elongation

Polymer overjacket, Standard Ultrathin Pebax, Nylon, Polyimide, FEP, Polyethethylene

 

PTFE coating

 

Marker bands;

- Laser

- Printed

- Chemical etching surface roughening for bond zones

- PTFE ID liner

TRANSITION SOLUTIONS

COMPONENTS PERFORMANCE

Burr free

Skive

Wire Weld

Flare

Slot & Crimp

Ground

Microwelded components 

 

Insert molded thermoplastic components 

Laser profiled cut geometries  for;

- Flexibility

- Torque

-Compression

 

microscope

Material Science Laboratory Capabilities

Our state of the art materials laboratory is equipped with advanced characterization equipment and staffed by a team of experienced metallurgists, polymer and materials scientists. Examples of research activities include the investigation, development and improvement of the fine-scale microstructure of technologically important materials. Through this work, the team develops innovative materials for advanced delivery device solutions.

Material Science Services

In addition, the laboratory staff offer materials consultancy to both in-house engineers and our customers. A range of materials science services can be provided including:

  • Custom material solution
  • Structure or defect investigation
  • Tensile and compression testing
  • Column strength testing
  • Bend testing
  • Kink testing
  • Micro hardness testing
  • Track and 3 dimensional push testing

 

spiral cut hypotube
Left: Cut & cleaned kerf // Right: Spiral cut hypotube

Technical resources include metallographic facilities, light optical microscopes, a scanning electron microscope suite, a range of mechanical testing instruments and advanced heat treatment capabilities.

proximal shaft
Pro X, PoleVault and MICROFLEX.

Innovative Platform Technologies

for your metal shaft and hypotube design

Pro X - The ultimate proximal shaft. 

Pro X is a proximal shaft sub-assembly that offers the ultimate design, service and cost model for an Rx catheter. This high-performance proximal shaft offers premium design features at lowest total cost and is manufactured in a high yield, robotic and full automated environment.

 

PoleVault™ - The gold standard hypotube.

PoleVault™ is a hypotube solution with up to 40% kink resistance. PoleVault™ hypotubes are specifically designed to optimise catheter performance, thus increasing physicians confidence in your product, reducing patient risk and maximising catheter revenue. 

 

MICROFLEX - a highly flexible micro metal tube >0.013”.

The MICROFLEX micro hypotube is specifically developed for minimally invasive treatment of the body’s smallest vasculature including interventional neuroradiology and is available in dimensions of 1f or less. The single piece construction provides the physician with a consistent user experience, it is completely customisable which presents limitless design possibilities and, the single piece design also maximises end-product margins by decreasing component and assembly costs. 

Technical Archive

Available to download - a series of whitepapers and industry publications written by our technical experts. Download to learn more about hypotube design and development.