3. SCIENTIFIC AND TECHNICAL BACKGROUND (See detailed report by Dr Fabienne Nsanze “ICT implants in the human body – a review” of February 2005 – annexed to this Opinion) 3.1. Current Applications and Research 3.1.1. Applications: ICT implants on the market This section contains information about implants in the human body that are available in commercial form and have been researched, in some cases, for decades. Active medical devices The history of implantable devices in clinical practice started in the 1960s with the development of the first heart pacemakers to replace the autonomic rhythm of the heart. Systems for bladder stimulation that allow paraplegics (paralysis of the lower limbs often resulting from spinal cord injuries) to control voiding followed in the 1980s. The most recent examples of active implants for functional electrical stimulation are stimulators to treat pain in patients with tumours and trembling caused by Parkinson’s disease, and to restore the grasp function in quadriplegics (paralysis of the arms, legs and trunk below the level of an associated spinal cord injury). Typical devices include the following: • Cardiovascular pacers for patients with conduction disorders or heart failure • Cochlear implants: the cochlear implant differs from the hearing aid in that it does not amplify sound and bypasses the damaged part to send sound signals directly to the auditory nerve. • Auditory Brainstem implant (ABI) is an auditory prosthesis that bypasses the cochlea and auditory nerve to help individuals who cannot benefit from a cochlear implant because the auditory nerves are not working. The brainstem implant stimulates directly the cochlear nucleus situated in the brainstem. • Implantable programmable drug delivery pumps: Administration of Baclofen for patients with Multiple Sclerosis with severe spasticity (intrathecal administration i.e. within the spinal canal) Insulin pump for Diabetes 7 • Implantable Neurostimulation Devices: the term “neurostimulation” relates to technologies that do not directly stimulate a muscle as a functional electrical stimulation device (i.e., cardiac pacemakers). Rather, neurostimulation technologies modify electrical nerve activity. Spinal cord stimulation for chronic pain management Sacral nerve stimulation for treatment of refractory urinary urge incontinence Vagus nerve stimulation (VNS) for seizure control in epilepsy or for mood control in severe depression cases • Deep brain stimulation (DBS): for tremor control in patients with Parkinson’s disease for essential tremor: Patients with essential tremor have no symptom other than tremor, which may occur in their hands, head, legs, trunk or voice. As for patients with Parkinson’s disease, they can be helped with deep brain stimulation therapy. • Artificial chip-controlled leg: the German company Otto Bock Healthcare GmbH has developed a prosthesis called “C-Leg®” which is a chip-controlled leg. Identification and location devices Microchip devices come in three forms: 1) Read-Only: this is the simplest form of devices that have a read-only character, similar to that now used for identification of animals. Even this most basic form would have numerous applications, for example, to identify Alzheimer’s patients, children and the unconscious. A broader use would be as a sort of national identification card, based upon the identifying number carried on the microchip. 2) Read-Write: this type of microchip would be capable of carrying a set of information which could be expanded as necessary. It allows the storage of data and is programmable at distance. For example, when the microchip carries a person’s medical history and the history evolves, the subsequent information could also be added to the microchip without the necessity of removing the implanted chip. It could also facilitate and record financial transactions. The third important set of information that a read-write microchip could carry might be criminal records. 3) Devices with tracking capabilities: besides the read-write capabilities described above, a device can also emit a radio signal which could be tracked. Applications would again be numerous as evidenced by the less advanced technologies already in existence. Such a 8 device needs a power source that has to be miniaturized before being implantable. With a microchip implant, constant monitoring would be possible. If each chip emitted a signal of a unique identifying frequency, implanted individuals could be tracked by simply dialling up the correct signal. Because the receiver is mobile, the tagged individual could be tracked anywhere. Typical devices include: • RFID devices: millions of Radio frequency identification (RFID) tags have been sold since the early 1980s. They are used for livestock, pet, laboratory animals, and endangered- species identification. This technology contains no chemical or battery. The chip never runs down and has a life expectancy of 20 years. • VeriChipTM or the “human bar code”: VeriChipTM (www.4verichip.com) is a subdermal RFID device, about the size of a grain of rice, which is implanted in the fatty tissue below the triceps. Current applications of the VeriChip include: Medical records and healthcare information (blood type, potential allergies and medical history) Personal information/identity: In the Baja Beach Club (in Spain and The Netherlands, http://www.baja.nl), people use the VeriChipTM like a smartcard to speed up drink orders and payment. Financial information (secondary verification) Besides these areas, the extended applications include public transportation security, access to sensitive buildings or installations and tracking down people on parole, ex- convicts, criminals, etc. Currently, a person has to stand within a few feet from a scanner for the tag to “wake up”. Thus, the tags can be used to follow someone’s steps only when they are near scanners. Consequently, the VeriChipTM is, for the moment, not an implantable GPS (Global Positioning System) device. • The Bavarian company Ident Technology (http://www.ident-technology.com) offers tracking devices using the human body (particularly the skin) as a digital data transmitter. • Female remote-control Orgasm Implant: A machine that delivers an orgasm at the push of a button was patented in the US in January (2004).