A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Paralysis

What happened to the BION®?

Posted on by Posted in Advanced Bionics, Alfred E. Mann, Axonics, Bluewind Medical, Boston Scientific, Electrode Materials, General Stim, Incontinence, Muscular Stimulation, Nalu, Neural Stimulation, Neuspera, Paralysis, University of Southern California, Valencia Technologies
RF-powered Bion stimulator

First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering

In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.

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BCI Developer Synchron Acquires Equity Stake in Nitinol Part Maker ACQUANDAS

Posted on by Posted in AIMD Business, ALS, Brain-Computer Interface, EEG Monitoring, Paralysis, Synchron
Synchron stent electrode

Image Credit: Synchron

Brain-computer interface (BCI) developer Synchron announced the acquisition of an equity stake in ACQUANDAS, a provider specializing in  high-precision nitinol components.

Synchron is developing endovascular technology to restore functionality in patients with motor impairment.    Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.

First Human Implant of Neuralink BCI

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Paralysis, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Elon Musk posted on X that Neuralink conducted the first human implant of its brain-computer interface:

Image Capture from X

Details are scant at this time, but Neuralink announced back in September ’23 that they had started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).

ONWARD® Announces First-in-Human Implant of ARC-IM™ with BCI to Restore Arm, Hand, and Finger Function after SCI

Posted on by Posted in Brain-Computer Interface, EEG Monitoring, Neural Stimulation, Onward, Paralysis, Spinal Cord Injury (SCI)
ONWARD ARC device with BCI

Image Credit: ONWARD

Onward announced the successful first-in-human implant of its ARC-IM Stimulator, to restore upper extremity function after SCI. The patient also received a wireless brain-computer interface (BCI), designed to initiate thought-driven movement when paired with ARC-IM.

According to the announcement:

“Working in concert with ARC-IM, the BCI is engineered to capture the intention of a paralyzed individual to move their upper extremities and uses artificial intelligence to decode those thoughts. ARC-IM then converts the decoded information into ARC-IM Therapy – precise stimulation of the spinal cord – resulting in thought-driven movement.”

 

 

Parandromics Raises $20M to Develop High Data Rate BCI

Posted on by Posted in AIMD Business, Brain-Computer Interface, EEG Monitoring, Paralysis, Parandromics

Image Credit: Parandromics

The scene has been hot for brain-computer interfacing (BCI) since Elon Musk announced its Neuralink project.  One of Neuralink’s competitors is Austin-based Paradromics Inc., founded in 2015, about a year ahead of Neuralink.  Bloomberg reported that Parandromics recently raised $20M to continue developing its high data rate implantable BCI.

Parandromics announced back in January 2020 that it had developed an implantable, low-power, high data rate neural sensor to enable massively parallel neural recordings for next-generation therapeutic applications.  From the press release:

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Synchron’s Stentrode™ Endovascular Neural Interface for BCI

Posted on by Posted in Brain-Computer Interface, Paralysis, Synchron
Stentrode by Synchron

Image Credit: Synchron

Synchron is a Silicon Valley company that spun out of the University of Melbourne, Australia in 2012. It was started by Thomas Oxley, MD, PhD to develop a new concept for a Brain-Computer Interface

Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.

Synchron is currently preparing for pilot clinical trials of the Stentrode™ to evaluate the safety and efficacy of this breakthrough technology.

Synchron’s website is at: https://www.synchronmed.com

Conceptual use of the Stentrode device
Image Credit: University of Melbourne

WEL Neuci-3M – An Ukrainian Neurostimulator for Nerve Regrowth

Posted on by Posted in Pain, Paralysis, Spinal Cord Stimulation, WEL (Kiev)

Neuci-3M by WEL

I was recently invited to visit a company in Kiev, Ukraine which manufactures implantable neurostimulators intended to cause nerve regrowth after spinal-cord or peripheral-nerve injury.

WEL was founded in 1993 for the development and production of electronics and microelectronics products. Its design and manufacturing facilities are located within a Soviet-era microelectronics manufacturing complex that is now largely abandoned.

WEL’s bread-and-butter is the production of industrial power control systems, but got into the medical implantables business after a request from a local hospital treating spinal-cord injury war casualties.

WEL’s main neurostimulator system is the “Neuci-3M” two-channel, externally RF-powered system. The implant is a simple two-frequency passive receiver potted in epoxy and overmolded with silicone rubber. The external transmitter is responsible for controlling all stimulation parameters. WEL also produces their own leads, including one with “petal” electrodes specifically for the stimulation of nerve regrowth.

WEL’s homepage is at: http://www.wel.net.ua/  They don’t have an English webpage, but Google translate does pretty well when viewing the page through Chrome.

Clinical work with this neurostimulator is conducted mainly by the Academician A. P. Romodanov Institute of Neurosurgery of the Academy of Medical Sciences of Ukraine.

Cleveland FES Center’s Networked Neural Prosthesis

Posted on by Posted in Brain-Computer Interface, Cleveland FES Center, Muscular Stimulation, Paralysis, Spinal Cord Injury (SCI)

Cleveland FES - Networked Neural Prosthesis (NNP) system, www.implantable-device.com, David Prutchi, Ph.D.

The Cleveland FES Center was established in 1991 as a consortium between the Cleveland VA Medical Center (CVAMC), the private educational institution of Case Western Reserve University (CWRU), and the public hospital system of MetroHealth Medical Center (MHMC).

As part of this consortium, Dr. Hunter Peckham – biomedical engineering professor at Case Western Reserve University – and his group have developed the Networked Neuroprosthetic System (NNPS), which is based on a network of small implanted modules they call “neuroprosthetic building blocks”.  These modules are distributed throughout the body, and each is dedicated to a specific function.  Modules are linked to a centralized power source via a network cable through which they also communicate with each other.

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Brown University Develops Fully-Implantable Brain-Computer Interface

Posted on by Posted in Brain-Computer Interface, EEG Monitoring, Paralysis

Brown University's fully-implantable brain-computer interface www.implantable-device.com David Prutchi, PhD

From Brown University’s press release:

“In a significant advance for brain-machine interfaces, engineers at Brown University have developed a novel wireless, broadband, rechargeable, fully implantable brain sensor that has performed well in animal models for more than a year. They describe the result in the Journal of Neural Engineering and at a conference this week.

PROVIDENCE, R.I. [Brown University] — A team of neuroengineers based at Brown University has developed a fully implantable and rechargeable wireless brain sensor capable of relaying real-time broadband signals from up to 100 neurons in freely moving subjects. Several copies of the novel low-power device, described in the Journal of Neural Engineering, have been performing well in animal models for more than year, a first in the brain-computer interface field. Brain-computer interfaces could help people with severe paralysis control devices with their thoughts.

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NDI Medical’s Miniature MicroPulse Neurostimulator

Posted on by Posted in Incontinence, Medtronic, Muscular Stimulation, NDI Medical, Pain, Paralysis, Spinal Cord Stimulation, SPR Therapeutics, Wireless Power Transmission
NDI Medical MicroPulse rechargeable neurostimulator
Image Credit: SPR Therapeutics

NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products.  NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.

According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:

“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.

To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading→