How to Design a Complex Catheter Shaft

November 15, 2021 / Resources

Complex catheter shaft designs are typically required for applications that require high performance access and delivery solutions.

This is typically encountered when dealing with delivery of Aortic valves, but are also present in Mitral and Tricuspid valve repair and replacement technology, Cardiac Assist device delivery and placement, and closure devices.

They can also be required for non-structural heart applications which require high precision and placement accuracy and devices that deliver therapy solutions which have high loads.

 

The structure of the shaft is based on the requirements of the shaft:

1. Large profile shafts to accommodate large implants that are typically associated with valve replacement and LVAD delivery applications, but having the ability to track to the targeted location. ICS have developed sheaths and delivery systems 36Fr+.

2. The flexibility of the catheter shaft and device to navigate to difficult anatomical tortuosity without kinking.

3. Steering for access to the targeted anatomy and precise positioning control of the diagnostic or therapy solution. ICS is developing shafts with 4-way multi plane / multi joint steering control.

4. Shaft telescoping functionality to allow delivery of implants, including shaft tensile and compression optimisation to ensure full and accurate delivery and perhaps allow options for implant retrieval or implant repositioning during procedures.

Typically, these configurations are mechanically challenging as shafts are multifunctional, must operate in synergy, and usually must come together in a handle that allows the user to manipulate and control the device.

 

The main performance driver of a complex shaft is its structure.

1. The main focus in shaft design will be the structural reinforcement included in the shaft, e.g., braided/coils/laser cut or hybrids/combinations of these reinforcements.

Typically:

  • A braid will drive shaft tensile and flexibility
  • Coils will improve kink and flexibility but will be weaker on tensile
  • But a compression coil will be good on compression!
  • Laser cut sections can provide a multiple of very precise properties
  • Combining sections in series or in parallel can provide unique performance solutions.

2. Liners for lubricity (if delivering an implant or other mechanical solution requiring low friction).

3. Jackets which help define shaft flexibility and contribute to shaft mechanical performance.

4. Pull wires for mechanical actuation, for example – is steering control required or are wires/sutures required for implant delivery

5. Other Integrated technologies, e.g., will there be sensors, electrodes, etc. built into the catheter shaft lumens or walls?

 

ICS capabilities

ICS Medical Devices has over 200 years of engineering experience under one roof, with a full suite of catheter shaft technologies onsite to allow us to rapidly prototype, develop and commercialise catheter shaft solutions to meet your needs.

The ICS development group is continually developing shaft and full device solutions for our customers in the areas of mitral valve repair and replacement, tricuspid valve repair and replacement, LVAD delivery and a range of other applications in structural heart, peripheral vascular, endoscopic and electrophysiology applications requiring complex catheter shafts.

  • Profile: ICS is developing shafts 36Fr+ in profile and as low as 2Fr.
  • Flexibility: ICS is developing shafts for novel technologies in structural heart, peripheral, neurovascular, endoscopic and ENT applications. We are continuously responding to the challenges that the medical device community is innovating towards.
  • Steering: ICS has developed shafts with up to 4-way multi plane / multi joint steering and control.
  • Shaft Load Capability: High tensile steering for the larger shafts. Shafts with optimum compression and tensile load performance.
  • Shaft telescoping: ICS possesses significant expertise in multi-functional multiple shaft designs typically encountered in implant delivery.

 

Contact us today to speak directly to one of our engineers about how we can assist you in bringing your catheter concept to market.

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