ACTIVE IMPLANTABLE MEDICAL DEVICES

Printed implantable electrodes are a great example of how our superior biomaterial properties can improve performance in active implantable medical devices.

One of the most dynamic sectors in healthcare is the active implantable medical device (AIMD) with unique products to include pacemakers, defibrillators and other cardia rhythm management devices. Outside the cardiac market though, there is another field within AIMD that is rapidly growing, and this is Neuromodulation.

Neuromodulation is the therapeutic alternation, stimulation, inhibition or regulation of activity in the central, peripheral or autonomic nervous system, electrically or pharmacologically and includes treatments for chronic pain management, stimulation for movement disorders, urological disorders, spasticity and gastric deficiencies

As researchers seek to better understand neural networks, improve existing therapies and develop new ones, printed implantable electrodes may provide performance, size, and cost benefits. PEEK-OPTIMA polymers have been analysed to assess its potential benefits to the AIMD sector. These include:

  • Sterilisation resistance to conventional methods including steam, gamma radiation and ethylene oxide (ErO) process without the degradation of mechanical properties or biocompatibility,2
  • Tailored implant radiopacity achieving an appropriate balance of implant, bone and tissue visualisation. Our biomaterials address the demand for enhanced in situ implant visualisation through a more natural radiolucency compatible with imaging techniques such as X-ray, MRI and computer tomography,2
  • Mechanical performance combining strength, stiffness and toughness even after sterilisation. Furthermore, our biomaterials offer extreme resistances to hydrolysis and implantable stability with no adverse influence on its mechanical properties. Tailormade, allow adding reinforcing fibres to increase strength if needed, yet still able to provide creep resistance, light weight and imaging. Thin wall impact strength properties of implantable made with PEEK-OPTIMA polymers were found to be within the range of traditional implantable metals, which is particularly important in structural AIMD applications such as components and enclosures,2
  • The dielectric strength properties of PEEK-OPTIMA polymers are stable over a range of temperatures, humidities and frequencies, suitable for use in electrical insulation applications.2 As an electrical insulating material, our biomaterials display clear telemetry advantages over implantable metals, allowing for radio frequency communications with no energy attenuation.2 In addition, implantable batteries can be induced charged through a PEEK barrier with no heat being generated from eddy current losses

Research into the adhesion behaviour in PEEK-OPTIMA implantables has enabled designers with a range of AIMD solutions, which include fusion welding, laser welding, ultrasonic welding and adhesive joining, all of which are proven to generate strong joints.2 Tests conducted with several adhesives concluded that the strength of PEEK-to-peek joints using implantable silicone adhesive remained mostly unchanged before and after sterilisation by steam, ErO and gamma.2

Printed implantable electrodes are one of many examples of how our biomaterials deliver superior device performance. Receptive to being printed on by normal methods such as screen, transfer and ink-jet printing, platinum and silver PEEK electrodes are flexible and resistant to manual bending, ultraviolet and EtO sterilisation and 72-hour saline immersion.

REFERENCES:

  1. N. Sereno (2010). The Use of PEEK for Advanced Active Implants, European medical device technology, 2010, vol. 1, no3, pp. 22-25 [4 page(s) (article).
  2. Supportive information available on request.
  3. Tavakoli, M. et al., 2004. An Assessment of Adhesive Bonding of PEEK-OPTIMA for Medical Device Applications. Proceedings of Medical Polymers, pp.35–51.

Applications

Examples of applications that are benefiting from Invibio

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