The Bionic Clicker Mark I &amp; II

In this manuscript, we present two 'Bionic Clicker' systems, the first designed to demonstrate electromyography (EMG) based control systems for ...

University College London

Hermeticity is crucial for the long-term implantation of electronic packages. Pushed by advances in micromachining, package volumes are decreasing and current leak detection methods are no longer sensitive enough. This article reviews the limits of the most common methods and exposes their inadequateness for medical electronic applications where the device's life is 50 years or longer.

The limits of hermeticity test methods for micropackages.

After spinal cord injury, electrical stimulation of the roots inside the spinal column at the level of the cauda equina is a safe and effective way to regain some degree of control over lower body function, e.g. bladder and bowel management and leg movement. The success of current systems used for so-called intrathecal stimulation is limited by the low number of stimulation channels, which are in consequence of the maximum acceptable number of transdural cables. In order to overcome this limitation, we developed an active electrode with integrated electronics, providing four individual stimulation channels that requires one cable only. This paper outlines the different elements of the so-called active book with the emphasis on its preliminary construction and assembly.

Realization of an active book for multichannel intrathecal root stimulation in spinal cord injury--preliminary results.

One reason given for placing capacitors in series with stimulation electrodes is that they prevent direct current flow and therefore tissue damage under fault conditions. We show that this is not true for multiplexed multi-channel stimulators with one capacitor per channel. A test bench of two stimulation channels, two stimulation tripoles and a saline bath was used to measure the direct current flowing through the electrodes under two different single fault conditions. The electrodes were passively discharged between stimulation pulses. For the particular condition used (16 mA, 1 ms stimulation pulse at 20 Hz with electrodes placed 5 cm apart), the current ranged from 38 to 326 μA depending on the type of fault. The variation of the fault current with time, stimulation amplitude, stimulation frequency and distance between the electrodes is given. Possible additional methods to improve safety are discussed.

Safety of multi-channel stimulation implants: a single blocking capacitor per channel is not sufficient after single-fault failure.

High density feedthroughs have been developed which allow for the integration of chip-scale features and electrode arrays with up to 1141 stimulating sites to be located on a single implantable package. This layered technology displays hermetic properties and can be produced from as little as two laminated 200 Î¼m thick alumina sheets. It can also be expanded to a greater number of layers to allow flexible routing to integrated electronics. The microelectrodes, which are produced from sintered platinum (Pt) particulate, have high charge injection capacity as a result of a porous surface morphology. Despite their inherent porosity the electrodes are electrically stable following more than 1.8 billion stimulation pulses delivered at clinically relevant levels. The ceramic-Pt constructs are also shown to have acceptable biological properties, causing no cell growth inhibition using standard leachant assays and support neural cell survival and differentiation under both passive conditions and active electrical stimulation.

Integrated electrode and high density feedthrough system for chip-scale implantable devices.

This paper presents an integrated stimulator that can be embedded in implantable electrode books for interfacing with nerve roots at the cauda equina. The Active Book overcomes the limitation of conventional nerve root stimulators which can only support a small number of stimulating electrodes due to cable count restriction through the dura. Instead, a distributed stimulation system with many tripole electrodes can be configured using several Active Books which are addressed sequentially. The stimulator was fabricated in a 0.6-μm high-voltage CMOS process and occupies a silicon area of 4.2 × 6.5 mm(2). The circuit was designed to deliver up to 8 mA stimulus current to tripole electrodes from an 18 V power supply. Input pad count is limited to five (two power and three control lines) hence requiring a specific procedure for downloading stimulation commands to the chip and extracting information from it. Supported commands include adjusting the amplitude of stimulus current, varying the current ratio at the two anodes in each channel, and measuring relative humidity inside the chip package. In addition to stimulation mode, the chip supports quiescent mode, dissipating less than 100 nA current from the power supply. The performance of the stimulator chip was verified with bench tests including measurements using tripoles in saline.

Active books: the design of an implantable stimulator that minimizes cable count using integrated circuits very close to electrodes.

Gastrointestinal stimulator implants have recently shown positive results in treating obesity. However, the implantation currently requires an invasive surgical procedure. Endoscopy could be used to place the gastric stimulator in the stomach, hence avoiding the riskier surgery. The implant then needs to go through the oesophagus and be located inside the stomach, which imposes new design constraints, such as miniaturization and protecting the electronic circuit against the highly acidic environment of the stomach. We propose to protect the implant by encapsulation with silicone rubber. This paper lists the advantages of this method compared to the more usual approach of a hermetic enclosure and then presents a method to evaluate the underwater adhesive stability of six adhesive/substrate couples, using repeated lap-shear tests and an elevated temperature to accelerate the ageing process. The results for different adhesive/substrate couples tested, presented on probability plots, show that FR4 and alumina substrates with MED4-4220 silicone rubber are suitable for a first implantable prototype. We then compare these with the predicted lifetimes of bonds between historical standard silicone rubber DC3140 and different substrates and describe the encapsulation of our gastrostimulator.

Silicone rubber encapsulation for an endoscopically implantable gastrostimulator.

Microchannel neural interfaces (MNIs) overcome problems with recording from peripheral nerves by amplifying signals independent of node of Ranvier position. Selective recording and stimulation using an MNI requires good insulation between microchannels and a high electrode density. We propose that stacking microchannel laminae will improve selectivity over single layer MNI designs due to the increase in electrode number and an improvement in microchannel sealing.

Microchannel neural interface manufacture by stacking silicone and metal foil laminae.

Gastrointestinal stimulator implants have recently shown positive results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. Our team is aiming for a less invasive procedure to stimulate the stomach with a gastrostimulator. Attempts covered fully endoscopic implantation and, more recently, we have focussed on a single incision laparoscopic procedure. Whatever the chosen implantation solution, the electronic design of the implant system shares many challenges. This paper covers the work achieved to meet these.

Design and Implementation of a Less Invasive Gastrostimulator.

Cross-talk phenomena should be avoided when stimulating nerves. One option to limit the current spread is to use tripolar electrodes, but at the cost of increasing the number of wires connection. This should be avoided since cables must be thin and compliant. We investigated the impact of the central electrode position and of current spread due to a gap between book and lid on cross-talk, in a set of tripolar or quasi-tripolar configurations..

A Study on Cross-Talk Nerve Stimulation: Electrode Placement and Current Leakage Lid.

In this document we discuss the main challenges encountered when producing flexible electrical stimulation implants, and present our approach to solving them for prototype production. We include a study of the optimization of the flexible PCB design, the selection of additive manufacturing materials for the mold, and the chemical compatibility of the different materials. Our approach was tested on a flexible gastro-stimulator as part of the ENDOGES research program.

Soft Encapsulation of Flexible Electrical Stimulation Implant: Challenges and Innovations.

High-density electrode arrays are a powerful tool in both clinical neuroscience and basic research. However, current manufacturing techniques require the use of specialised techniques and equipment, which are available to few labs. We have developed a high-density electrode array with customisable design, manufactured using simple printing techniques and with commercially available materials.

Article	Year
The limits of hermeticity test methods for micropackages. Artificial organs\| PubMed ID: 21401667	2011
Realization of an active book for multichannel intrathecal root stimulation in spinal cord injury--preliminary results. Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference\| PubMed ID: 22254963	2011
Safety of multi-channel stimulation implants: a single blocking capacitor per channel is not sufficient after single-fault failure. Medical & biological engineering & computing\| PubMed ID: 22391946	2012
Integrated electrode and high density feedthrough system for chip-scale implantable devices. Biomaterials\| PubMed ID: 23706781	2013
Active books: the design of an implantable stimulator that minimizes cable count using integrated circuits very close to electrodes. IEEE transactions on biomedical circuits and systems\| PubMed ID: 23853144	2012
Silicone rubber encapsulation for an endoscopically implantable gastrostimulator. Medical & biological engineering & computing\| PubMed ID: 25559120	2015
Microchannel neural interface manufacture by stacking silicone and metal foil laminae. Journal of neural engineering\| PubMed ID: 27001943	2016
Design and Implementation of a Less Invasive Gastrostimulator. European journal of translational myology\| PubMed ID: 27478566	2016
A Study on Cross-Talk Nerve Stimulation: Electrode Placement and Current Leakage Lid. European journal of translational myology\| PubMed ID: 27990238	2016
Soft Encapsulation of Flexible Electrical Stimulation Implant: Challenges and Innovations. European journal of translational myology\| PubMed ID: 28078073	2016
In vitro biocompatibility and electrical stability of thick-film platinum/gold alloy electrodes printed on alumina. Journal of neural engineering\| PubMed ID: 28272027	2017

Anne Vanhoestenberghe

Biography

JoVE Journal Publications

Other Publications