D4 – Steering deep brain stimulation
Demonstrator leader: Juan Ordonez Orellana (Medtronic)
 
Introduction
Deep brain stimulation (DBS) is a minimally invasive neurosurgical therapy for symptomatic treatment of various neurological disorders. It was approved as a treatment for essential tremor in 1997, for Parkinson's disease (PD) in 2002, and dystonia in 2003. It has since then been used in more than 100,000 patients. DBS can be envisioned as a ‘pacemaker for the brain’; mild electrical stimuli are delivered to brain tissue, via implanted leads, to suppress unwanted activity and restore desired neuronal functions.
Recent developments by Sapiens in high-resolution lead design enable Steering Brain Stimulation (SBS) to reduce the side-effects, while maintaining the stimulation intensity levels that are required for full therapeutic benefit. The leads are connected to an implantable pulse generator via an extension cable just underneath the skin.
 
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Left: State-of-the-art DBS system; Right: clinical trials have proven that the segmented steering probe of SAPIENS can prevent side effects normally associated with DBS.
 
 
Industrialization challenges
Neurologists and neurosurgeons are uncovering more and more therapeutic applications of DBS for a wide range of brain diseases such as dystonia, obsessive-compulsive disorder, epilepsy and Gilles de la Tourette or exploratory fields like cluster headache, obesity and depression. While DBS, due to current technical limitations, already has its limitations for targeting PD, many of the newly discovered brain targets are even smaller and more complex in shape. Adequately addressing these indications for larger patient populations requires a radical improvement in DBS system design beyond the state-of-the-art.
A lead design with more than 80 electrodes is required to address the various targets that are associated with the various indications. In addition, new interface materials between the electrodes and the brain tissue have been identified to enable improved brain recordings to validate the correct placement of the lead and the efficacy of the treatment, while at the same time warranting sufficient autonomy of the primary battery. Moving towards 80 electrodes readily requires new approaches for assembling the lead from the thin-film on which the electrodes are created. Moving beyond 80 electrodes is only expected to be feasible by using an active lead design with a multiplexing circuitry embedded into the 1.3 mm diameter tip.
 
 
Approach
Proof-of-principles are available for the thin-film manufacturing, the multiplexing electronics, the encapsulation of the multiplexing ASIC and its assembly with the thin-film, as well as the new interface material of the electrodes. While the underlying proof-of-principles are available in the various research and development laboratories of the participating partners, an orchestrated effort is required to work an integrated design beyond the valley-of-death between R&D and manufacturing.
A three stage approach is taken to increase the resolution in stimulation and recording, requiring break-troughs in smart system and heterogeneous integration and polymer processing:
  1. Increase the number of electrodes and leads to 80 to increase steering resolution
  2. Integrate electronics in the tip of the probe (“Chip-in-the-Tip”)
  3. Develop advanced conductive polymer electrodes
 
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Innovation pipeline
 
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Schematic project overview
 
 
Partner Role
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