The Bion microstimulator was originally designed for Functional Electrical Stimulation (FES). It was developed as a means to provide small stimulators distributed across a patient’s body without the need for interconnecting wires. Other systems implanted for FES, such as the Praxis system (Cochlear Ltd, Lane Cove, NSW, Australia) and the Freehand system (NeuroControl, Cleveland, OH, USA), utilize a central controller typically implanted in the trunk with a number of electrode leads directly connected from the central controller to the muscle targets in the limb(s).1,2 The central controller activates the electrodes directly. While this architecture has proven effective for FES, the necessity of running an electrode lead through a limb joint (e.g., shoulder joint) increase the amount of stress on the lead and may result in lead fracture. Additionally, an infection in any one part of the body would tend to spread to the rest of the system, which has led to an explant of the entire system.
The Bion microstimulator was developed to overcome the need to tunnel leads from a central controller. Each Bion microstimulator is a self-contained implantable electrical stimulator that requires no lead. Each device contains at least one pair of stimulating electrodes (cathode and anode) for stimulation.
The Bion® microstimulator is a miniature leadless implantable neurostimulator designed to be implanted through a minimally invasive procedure. The small profile of the microstimulator allows it to be implanted through a small incision. Additionally, the stimulating electrodes are mounted directly on the microstimulator, which eliminates possible complications associated with the use of a lead (e.g., migration). An RF-powered version of the Bion microstimulator was developed over a decade ago, and that device has been used in feasibility clinical studies for several functional electrical stimulation (FES) applications, including shoulder subluxation and post-stroke hand rehabilitation. It has also been explored in clinical applications for knee osteoarthritis rehabilitation and obstructive sleep apnea. A version of the Bion microstimulator with a rechargeable battery has also been developed, and the first-generation battery-powered microstimulator was used in a feasibility clinical trial for headaches. It is also being used in a clinical trial for overactive bladder. Preclinical experiments on the use of the microstimulator for gastroesophageal reflux disease have also been promising.
Each device also contains all of the electronics necessary to deliver electrical stimulation, including programmable memory so that stimulation parameters may be programmed and stored.
Additionally the devices contain a means of communication with an external programmer or controller, which is typically some type of radiofrequency (RF) telemetry. The Bion microstimulator contains a means of receiving RF energy from an applied RF field. The energy received is used to power the microstimulator. Some Bion microstimulators also contain a rechargeable battery, and excess received energy may be used to charge the battery.
The Bion microstimulator was designed to have a form factor that allows it to be implanted in a minimally invasive fashion. Bion microstimulator devices thus far have been designed with a cylindrical form factor, in which the diameter is 2.0 to 3.3 mm and the length is 27 mm or less. This allows a Bion microstimulator to be implanted in tissue in a manner similar to injection.
1990s First-Generation RF-Powered Bion Microstimulator (RFB1) was originally proposed by Loeb et al.3 as an RF-powered device.
The first devices were designed and developed by researchers at Queens University (Kingston, ON, Canada), the Illinois Institute of Technology (Chicago, IL, USA), and the Alfred E. Mann Foundation (Valencia, CA, USA) with funding from the NIH Neural Prosthesis Program. Subsequently, the RFB1 was produced by the Alfred Mann Institute for Biomedical Engineering at the University of Southern California (Los Angeles, CA, USA).
The first-generation RF-powered Bion microstimulator (RFB1) was designed to be injected or implanted directly into a muscle for direct stimulation of muscle tissue or of the local motor nerves supplying the muscle (e.g., for stimulation at a motor point). The device encased the electronics in a hermetically sealed glass capsule. It had a single tantalum capacitor electrode (cathode) on the front tip of the microstimulator to provide charge-balanced stimulation. The single anode was an iridium electrode mounted at the other end of the cylinder. The device had a diameter of 2 mm and a length of 16 mm...
Its not that government public officers & certain physicians don't "believe" me. Its that most have been paid for their silence or are too stupid to understand medical evidence. While others only work on rumours, not logic.
Implantable Electronic Stimulation Devices from Head to Sacrum: Imaging Features and Functions
- Published Online:Jul 8 2019
SCS Devices also known as dorsal column stimulation.
In 1967, Shealy et al (36) placed the first SCS system, and in 1989 the FDA approved the first SCS system for chronic back and limb pain. When placing an SCS system, the electrodes are placed adjacent to the dorsal columns, which conduct touch and proprioception information to the brain.
DBS Devices. The U.S. Food and Drug Administration (FDA) approved thalamic DBS for treatment of essential tremor and Parkinson disease–related tremor in 1997 and subthalamic nucleus and globus pallidus internus DBS for treatment of Parkinson disease in 2003 (1). The FDA humanitarian device exemption for DBS was approved for the treatments of dystonia in 2003 and obsessive-compulsive disorder in 2009 (1). Other reported applications include treatment of Tourette syndrome, medically resistant depression, epilepsy, obesity, headache, chronic pain, and dementia
VNS has been used for the treatment of a wide range of conditions, including seizure disorders, depression, heart failure, and other systemic disorders. The VNS Therapy system (LivaNova [formerly Cyberonics], Houston, Tex) was FDA-approved in 1997 for the treatment of focal seizures in adult and adolescent patients with medical refractory epilepsy.
The Mark IV Breathing Pacemaker (Avery Biomedical Devices, Commack, NY) received full FDA premarket approval in 1987 and is the most widely available system (57). The system is partially implanted and contains three internal components: electrodes, leads, and receivers (Fig 15). Electrodes are implanted on the phrenic nerves in the chest or in the neck. Cervical leads and electrodes can be placed in a single procedure, whereas thoracic leads and electrodes require separate procedures for each side, either by performing a video-assisted thoracoscopic surgery or an open thoracotomy. On the other hand, cervical electrodes have the disadvantage of requiring high current amplitude, which may stimulate the brachial plexus. In addition, constant neck movement may lead to phrenic nerve injury or lead breakage and/or migration.
SNS or sacral neuromodulation is used to treat symptoms related to voiding and defecation. There also have been case reports of SNS for the treatment of pelvic pain syndromes such as pudendal neuralgia (68). SNS with the InterStim system (Medtronic) was FDA approved in 1997 for urge incontinence, in 1999 for urinary retention and urinary frequency, and in 2011 for the treatment of chronic fecal incontinence (69). A new smaller Interstim II device (Medtronic) has since become available on the market. A rechargeable SNS device is manufactured by Axonics (Irvine, Calif); however, it is not FDA approved in the United States.
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