Saturday, March 12, 2016

Oh, patents! Quell®

Copyright © Françoise Herrmann

QUELL®, winner of an Innovation Award in the Wearable Tech category at SXSW® 2016, is wearable patented pain-relief technology that is 100% drug-free and non addictive. [Quell® (1)]
Developed by NeuroMetrix, Inc, Quell® is neurotechnology worn as an upper calf band, just below the knee. Quell® is Bluetooth™-enabled so that it can upload information and be controlled via a portable iOS or Android phone app.
The principle of the Quell® neurotechnology is to provide an electrode that stimulates sensory nerves according to a patented Optitherapy™ algorithmn of pulse waveform (intensity, duration and shape) and pulse pattern specification (frequency and duration of session), considering user feedback and within clinically specified parameters. 
Neurostimulation of sensory nerve fibers is thus delivered knowing that sensory nerves carry pulses to the brain, which in turn have the capacity to trigger the release of endogenous opioid-like peptides called enkephalins. The release of endogenous opioid-like enkephalins is a natural response with an analgesic effect that has the capacity to centrally block pain signals in the body. Additionally, the release of enkephalins targets δ-opioid receptors which are different from the μ-opioid receptors, targeted by opioid pain medication, thus creating a synergistic effect. [Quell® (2); Ghelardini et. al, 2015]
The Quell® technology called WINS (Wearable Intensive Nerve Stimulation) is FDA-approved for day and night treatment of chronic pain. It is recommended as an adjunct to medication for all sorts of chronic pain (e.g.; lower back and leg pain, diabetic pain and fibromyalgia). 67 % of users reported a reduction in the use of pain medication, 81 % in the reduction of chronic pain [Quell® (3)].
As the device works during the night, tracking sleep patterns too, it is also designed to break the cycle of pain-disrupted sleep, which amplifies pain and reduces activity during waking hours.
The various functions and aspects of the NeuroMetrix Inc. neurotechnology inventions are disclosed in at least 70 patents, embodied in three additional devices:

1. The wearable SENSUS® pain management system, developed more specifically for neuropathic pain, resulting for example from diabetes;
2.  The hand-held device called NC-Stat®- DPN-Check® for measuring and quantifying peripheral neuropathy, and
3. The Advance® NCS (Nerve Conduction Study) System, designed for studying and measuring nerve conduction in any setting.
US2015148865 titled Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation recites those apsects of the Quell® invention pertaining to the automated adjustment of the intensity of the neurostimulation and its intensification during a therapy session to avoid habituation. 
The Quell® invention disclosed thus resolves many of the prior art problems in the field of Transcutaneous Electrical Nerve Stimulation (TENS), in particular as related to portability of the devices, wiring, user training and user support to regulate the right amount of stimulation, duration of the sessions and the issues of habituation.
The Abstact of the invention is included below, as well as a patent drawing of the electrode band. An image of the marketed Quell® device is also included above.

Apparatus for transcutaneous electrical nerve stimulation in humans, the apparatus comprising: a housing; stimulation means mounted within the housing for electrically stimulating nerves; an electrode array releasably mounted to the housing and connectable to the stimulation means, the electrode array comprising a plurality of electrodes for electrical stimulation of nerves; control means mounted to the housing and electrically connected to the stimulation means for controlling at least one characteristic of the stimulation means; monitoring means mounted to the housing and electrically connected to the stimulation means for monitoring at least one characteristic of the stimulation means; user interface means mounted to the housing and electrically connected to the control means for controlling the stimulation means; display means mounted to the housing and electrically connected to the control means and the monitoring means for displaying the status of the stimulations means; and a strap attached to the housing; wherein the strap is configured to hold the housing, stimulation means and electrode array at a specific anatomical location to treat pain. [US2015148865] 

References
NeuroMetrix® Inc. http://www.neurometrix.com/
Quell® – Clinicians  https://www.quellrelief.com/clinicians
NC-Stat® - DPN-Check®  http://www.dpncheck.com/
Sensuc ® pain management system  http://www.sensusrx.com/
Advance™ system  http://www.advancencs.com/
Ghelardini,C.,  Di Cesare Mannelli, L. , & E. Bianchi (2015) The pharmacological basis of opioids
Clin Cases Miner Bone Metab. 2015 Sep-Dec; 12(3): 219–221 

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