Patent Application
20240189576
The present invention relates to apparatus and methods for applying electrical stimulation to the head region, particularly to areas having high impedance such as hair covered regions, to headsets having electrodes for treatment of medical conditions using non-invasive electrical stimulation, to headsets adapted to assess medical conditions, and to electrode arrangements for use with such headsets.
The present invention relates to apparatus and methods for applying electrical stimulation to the head region. The disclosed apparatus may be used for stimulation of peripheral and cranial nerves, for transcranial stimulation of brain regions, and for sensing various body parameters.
Peripheral and cranial nerves in the head region may be stimulated to treat various conditions such as chronic pain, migraine, tension headaches, cluster headaches, trigeminal and occipital neuralgia, fibromyalgia, depression, post-traumatic stress disorder (PTSD), anxiety, stress, bipolar disorder, schizophrenia, obsessive compulsive disorder (OCD), insomnia, epilepsy, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, obesity, multiple sclerosis, and brain injuries such as stroke and traumatic brain injury (TBI). The anatomy of peripheral and cranial nerves in the head region, such as that of the occipital and trigeminal nerves, and their projections to brainstem regions such as the locus coeruleus and nucleus raphe magnus, as well as to higher brain regions such as the thalamus and the cortex, may be advantageous when stimulating these nerves for treatment of such conditions.
Neurostimulation of superficial peripheral and cranial nerves in the head region, such as the occipital, supraorbital, supratrochlear, zygomaticotemporal, and auriculotemporal nerve branches, can be applied either invasively or non-invasively. Due to the challenge of transferring current through the hair, stimulation of cephalic nerves which lie under hair covered regions such as the occipital nerve (greater, lesser and third occipital branches), is typically carried out using implanted or percutaneous nerve stimulators. Such devices include electrodes that are inserted under the scalp and thus bypass the high impedance barrier formed by the hair and scalp. Such invasive procedures of peripheral nerve stimulation include occipital nerve stimulation which has shown to provide relief for chronic migraine in numerous clinical trials. Another more recent procedure for treatment of migraine combines stimulation of both occipital nerve branches (greater and lesser) and trigeminal nerve branches (mostly supraorbital and supratrochlear and occasionally also/or zygomaticotemporal and auriculotemporal). Recent clinical results support the expectation that applying peripheral nerve stimulation to a combination of the occipital and trigeminal nerve branches may result in a better outcome compared to stimulation of the occipital nerve or the trigeminal nerve alone. Indeed, the response rate for patients with head-wide pain who were treated with implanted peripheral nerve stimulation to the occipital and trigeminal nerves is reported to be better than 70%. This is an improvement from using stimulation to the occipital or trigeminal nerves only which is reported to bring about just a 40% response rate.
However, implanted peripheral nerve stimulation remains an invasive and costly procedure with a high rate of complications including infection, bleeding or fluid collection under the skin, as well as hardware-related malfunctions such as migration and breakage of the implanted leads and pulse generator failure.
Non-invasive stimulation of trigeminal nerve branches, such as the supraorbital and supratrochlear, was found to be safe as a preventive therapy for migraine and as treatment for other conditions such as seizures and depression. Additionally, transdermal stimulation of cephalic nerves such as the occipital nerve branches using non-invasive techniques is likely to achieve similar clinical benefits to those of implanted stimulators without the risks and cost associated with an invasive procedure.
Due to the challenge of transferring current through the hair, stimulation of the occipital nerve (greater, lesser and third occipital branches) is mostly performed with implanted nerve stimulators. In spite of that, the occipital nerve branches may also be stimulated Transdermally. When passing at approximately the anatomical height of the superior nuchal line of the occipital bone, the occipital nerve lies superficially under the skin and if electrodes are placed under the hair and close enough to the scalp, effective nerve excitation can be reached, achieving similar clinical benefits to those of implanted stimulation, without the risks associated with an invasive procedure.
Transcranial direct current stimulation (tDCS) is another modality that has been studied for treatment of various medical and/or physiological conditions such as chronic pain, migraine, depression, post-traumatic stress disorder, bipolar disorder, schizophrenia, epilepsy, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), Parkinson's disease, and Alzheimer's disease, as well as for assistance in recovery from stroke and traumatic brain injury and in cognitive learning. tDCS typically refers to the application of constant, low current stimulation in the range of 1-2 mA, delivered directly to an area of the brain, thereby to modulate the activity of targeted neurons. Typically, the electrode associated with the positive pole, or anode, causes an increase in activity of the target nerve, while the electrode associated with the negative pole, or cathode, causes a decrease in nerve activity.
That being said, non-invasive application of electrical current to the head, and specifically to regions that are covered by hair, poses numerous challenges. The hair and scalp create a high impedance barrier which makes it difficult to transfer electrical current to underlying nerves. High sensory sensitivity of the scalp and of the periosteum of the skull bone, as well as dermal vulnerability of the scalp tissue to electrical current, are additional considerations while attempting to non-invasively stimulate cephalic nerves.
The relationship between the current provided to a tissue, the impedance of the tissue, and the voltage required to provide the current, is characterized by Ohm's Law: V=I·Z, where V (voltage) is the potential difference between two electrodes placed over the head, Z is the impedance of the hair and scalp tissue, and I is the current flowing through the impedance. Thus, the voltage increases substantially proportionally to the impedance or resistance.
Non-invasive stimulation of nerves, such as the greater occipital, requires substantial current amplitude (2-18 mA), and high voltage levels (up to 150V) may be needed to transfer the current through the hair and scalp due to the high impedance associated therewith. Such high voltage levels are disadvantageous as they may injure the scalp tissue, be uncomfortable for the user, and/or may be wasteful in consumption of energy so that a large battery may be required in order to enable sufficient treatment time.
The impedance level varies significantly between people and tends to change with time. Several factors were identified as affecting the impedance level:
Non-dynamic factors, or factors related to differences between people, include:
Dynamic factors, which may vary between treatments and/or during a specific treatment for the same person, include:
Variations to the impedance, and specifically dynamic variations of the impedance in the electrode-scalp interface, may disadvantageously affect the ability to achieve effective and homogeneous stimulation of the target nerves or brain regions and may require constant attention and high skillfulness of the user when operating the device.
According to some teachings of the present invention there is provided a headset including:
According to some teachings of the present invention there is also provided a headset including:
In some embodiments, the user is a human user. In some such embodiments, the length of the elongate body member is smaller than 700 mm, 680 mm, or 660 mm.
In some embodiments, the body member has a rest state, and wherein, in the rest state, at least part of one of the arm sections overlaps at least part of the other of the arm sections.
In some embodiments, the force has a magnitude not greater than 20N, 15N, or ION. In some embodiments, the preload drives the arm sections toward the closed state. In some embodiments, the preload drive the arm sections toward the rest state.
In some embodiments, the predefined preload is adapted to ensure that the posterior ends of the arm sections engage the scalp of the user and plow between the hair during donning of the headset, such that when the headset is donned the at least one electrode or the at least one sensor is at least in direct physical contact with the scalp of the user.
In some embodiments, when the headset is donned, the at least one electrode or the at least one sensor is also in direct electrical contact with the scalp of the user.
In some embodiments, the arm sections are configured such that during donning of the headset, the posterior ends engage the sides of the head of the user forming an angle between the ends of the arm sections and the sides of the head of the user, which angle contributes to contact between the posterior ends and the scalp throughout donning of the headset. In some embodiments, the angle is in the range of 90 degrees to 20 degrees.
In some embodiments, the anterior section includes an anterior member, and the arm sections include arm members, distinct from the anterior member and connected thereto.
In some embodiments, the headset further includes at least one size-adjustment mechanism configured to enable adjustment of the circumference of the body member to comfortably fit circumferentially about heads having different circumferences. In some embodiments, the at least one size-adjustment mechanism includes a rigid size-adjustment mechanism. In some embodiments, the at least one size-adjustment mechanism includes two size-adjustment mechanisms, each associated with one of the arm sections. In some embodiments, the size-adjustment mechanism includes a ratcheting mechanism or a sliding mechanism.
In some embodiments, the body member includes at least one flexible temple arm portion, a pair of flexible posterior portions adjacent the posterior end of each of the arm sections, and the at least one size-adjustment mechanism.
In some embodiments, the body member includes a single flexible temple arm portion extending along the anterior section of the headset, and a pair of the flexible posterior portions.
In some embodiments, each of the arm sections includes a flexible temple arm portion adjacent the anterior section, and a flexible posterior portion adjacent the end of the arm section.
In some embodiments, a degree of flexibility of the at least one temple arm portion determines the resiliency of the arm sections.
In some embodiments, the posterior portion of each of the arm sections is curved, and curvature of the posterior portions are configured to contribute to continuous contact between the ends of the arm sections and the scalp throughout donning of the headset. In some embodiments, the posterior portions have a first curvature in the rest state and a second curvature during donning of the headset. In some embodiments, a first radius corresponding to the first curvature is smaller than a second radius corresponding to the second curvature. In some embodiments, the first radius is not greater than 150 mm. In some embodiments, in the closed state, curvature of the posterior portions conforms to curvature of the head of the user.
In some embodiments, during donning of the headset, the predefined preload acts mostly on the posterior ends of the arm sections.
In some embodiments, the size-adjustment mechanism is configured to be adjusted when the user first dons the headset, and subsequently to retain the size defined by the user, without requiring additional adjustment.
In some embodiments, the closure mechanism includes a magnetic closure mechanism including a magnetically attractable element at each of the posterior ends of the arm sections, the magnetically attractable elements being adapted to attract and engage one another, thereby to close the headset. In some embodiments, one of the magnetically attractable elements is a magnet and the other is formed of a magnetically attractable metal. In other embodiments, both the magnetically attractable elements are magnets.
In some embodiments, each of the magnetically attractable elements has at least a portion which defines a spherical surface and is disposed in a housing, wherein the spherical surfaces of the magnetically attractable elements are adapted to engage one another at a single point, thereby to close the headset. In some embodiments, the magnetically attractable elements are rotatably disposed in the housing and are adapted to automatically orient in an optimally polar orientation given a specific alignment of the posterior ends of the headset.
In some embodiments, the magnetically attractable elements are adapted to attract one another so as to close the headset when the magnetically attractable elements are at a distance not greater than 10 mm, not greater than 20 mm, or not greater than 30 mm.
In some embodiments, the at least one electrode has a resilient, flexible, sealing rim disposed therearound, such that when the at least one electrode engages a skin surface of the user, the sealing rim seals around the at least one electrode.
In some embodiments, the at least one electrode includes at least one anterior electrode mounted on an inner surface of the anterior section. In some embodiments, at least one of the at least one anterior electrode configured, when the headset is donned, to be disposed above at least one of the supratrochlear nerves and the supraorbital nerves of the user. In some embodiments, at least one of the at least one anterior electrode including a transcranial stimulation electrode configured, when the headset is donned, to be disposed above an anterior brain region of the user.
In some embodiments, the at least one anterior electrode includes a first anterior electrode and a second anterior electrode, each of the first and second anterior electrodes having a first end, a second end, a height, and a length, the heights of the first and the second anterior electrodes, at a maximal point thereof, being in the range of 10 mm to 40 mm, the first and second anterior electrodes arranged horizontally alongside one another on the elongate body member such that the second end of the first anterior electrode is adjacent the first end of the second anterior electrode with a distance therebetween, the distance being in the range of 1 mm to 15 mm, and a length consisting of the length of the first electrode, the length of the second electrode, and the distance, is in the range of 20 mm to 55 mm.
In some embodiments, the first anterior electrode is configured, when the headset is donned, to be disposed above the supratrochlear nerve on one side of the user's head, and the second anterior electrode is configured, when the headset is donned, to be disposed above the supraorbital nerve on the one side of the user's head,
In some embodiments, each of the first and second anterior electrodes includes a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, the first and second anterior electrodes are disposed on a joint substrate, the shared substrate including a first contact portion in electrical contact with the electrode backing of the first anterior electrode and a second contact portion in electrical contact with the electrode backing of the second anterior electrode.
In some embodiments, the ratio between an area of the first anterior electrode and an area of the second anterior electrode is in the range of 0.5-2. In some such embodiments, the area of the first electrode is equal to the area of the second electrode. In some embodiments, the first and second anterior electrodes have an identical contour.
In some embodiments, the first and second anterior electrodes extending, at a lower end thereof, along a single concave contour defined between first and second boundary points disposed at opposite ends of the concavity and adapted to generally follow the outline of the user's eyebrows,
A/L≥0.5 mm
H
max
/H
min≤2.5,
In some embodiments, an angle between the line and the second end of the first anterior electrode adjacent the distance is in the range of 45-110 degrees.
In some embodiments, the headset further includes at least one compressible portion mounted onto an inner surface of the body member and adapted to engage the skin of the user, the compressible portion extending radially toward the center of the headset. In some embodiments, the at least one compressible portion is adapted, when the headset is donned by the user, to be urged against skin of the user and to compress against the skin, such that the compressible portion extends radially toward the center of the headset to a greater degree when the headset is not donned by the user, than when the headset is donned by the user. In some embodiments, the at least one compressible portion is mounted on an inner surface of the anterior section.
In some embodiments, the at least one compressible portion comprises a compressible portion mounted onto a flexible leaf connected to the anterior section, the flexible leaf having a rest state and an extended state. In some such embodiments, in the extended state, a curvature of the flexible leaf corresponds to a curvature of the scalp of a user donning the headset. In some embodiments, the at least one compressible portion includes the at least one electrode and an electrode housing surrounding the at least one electrode, the electrode housing including at least one hollow chamber adapted for trapping liquid emitted from the at least one electrode when the at least one compressible portion and the at least one electrode are compressed.
In some embodiments, the anterior section including at least one positioning indicator enabling the user, during donning of the headset, to center the anterior section on the head of the user such that the at least one electrode or the at least one sensor is accurately positioned when the headset is donned.
In some embodiments, the body member further includes at least one posterior section disposed adjacent the posterior ends of the arm members. In some embodiments, the at least one posterior section includes an at least partially tapered section, tapering from a first portion having a first width to a second portion having a second width, smaller than the first width. In some embodiments, the at least partially tapered section terminates, at the second portion, in the closure mechanism.
In some embodiments, the at least one electrode includes at least one posterior electrode at least partially mounted on the posterior section. In some embodiments, at least one of the at least one posterior electrode being configured, when the headset is donned, to be disposed above at least one occipital nerve branch of the user. In some embodiments, at least one of the at least one posterior electrode including a transcranial stimulation electrode configured, when the headset is donned, to be disposed above an occipital brain region of the user.
In some embodiments, the at least one posterior electrode includes a first posterior electrode and a second posterior electrode, each of the first and second posterior electrodes having a first end, a second end, a height, and a length, the heights of the first and the second posterior electrodes being in the range of 5 mm to 35 mm, the first and second posterior electrodes arranged horizontally alongside one another on the elongate body member such that the second end of the first posterior electrode is adjacent the first end of the second posterior electrode with a distance therebetween, the distance being in the range of 1 mm to 10 mm, and a length consisting of the length of the first electrode, the length of the second electrode, and the distance, is in the range of 10 mm to 55 mm.
In some embodiments, the first posterior electrode is configured, when the headset is donned, to be disposed above a first occipital nerve branch on one side of the user's head, and the second posterior electrode is configured, when the headset is donned, to be disposed above a second occipital nerve branch on the one side of the user's head,
In some embodiments, each of the first and second posterior electrodes includes a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, the first and second posterior electrodes are disposed on a joint substrate, the joint substrate including a first contact portion in electrical contact with the electrode backing of the first posterior electrode and a second contact portion in electrical contact with the electrode backing of the second posterior electrode.
In some embodiments, the ratio between an area of the first posterior electrode and an area of the second posterior electrode is in the range of 0.5-2. In some such embodiments, the area of the first posterior electrode is equal to the area of the second posterior electrode.
In some embodiments, a joint contact surface including the contact surfaces of the first and second posterior electrodes has a generally frusto-conical outline defining a base and a curved tip, connected by a pair of side curves, and the first posterior electrode and the second posterior electrode are mirror image symmetrical about a horizontal axis of symmetry. In some embodiments, a curvature of the tip corresponds to that of a circle having a radius not greater than 10 mm, a curvature of the side curves corresponds to that of a circle having a radius of at least 50 mm, and an angle between the second end of the first posterior electrode and the horizontal axis of symmetry is in the range of 75-105 degrees.
In some embodiments, the posterior section includes a posterior section housing having at least one flexible surface and having the posterior electrode housed therein. In some such embodiments, the at least one flexible surface is adapted such that, when the headset is donned by a user and the at least one posterior electrode engages the scalp of the user, pressure applied to the at least one flexible surface causes deformation of the at least one flexible surface resulting in a conductive fluid being emitted from the at least one posterior electrode toward the scalp of the user, thereby to reduce the impedance between the at least one posterior electrode and the scalp of the user.
In some embodiments, the processing unit is disposed within the anterior section. In other embodiments, the processing unit is disposed within one of the arm sections.
In some embodiments, the processing unit includes a control element, functionally associated with the at least one electrode or with the at least one sensor, and configured to control operation of the at least one electrode or of the at least one sensor.
In some embodiments, the processing unit includes a receiver, functionally associated with the at least one electrode or with the at least one sensor, and configured to receive input from the at least one electrode or from the at least one sensor.
In some embodiments, the processing unit includes a transceiver, functionally associated with the at least one electrode or with the at least one sensor, and configured to control operation of and to receive input from the at least one electrode or the at least one sensor. In some embodiments, the transceiver includes a wireless communication transceiver configured to receive control instructions from a remote control device using a wireless communication protocol.
In some embodiments, the processing unit is mounted on the body member and communicates with the at least one electrode or at least one sensor via at least one electrical conductor. In some embodiments, the at least one electrical conductor extends along at least one of the arm sections.
In some embodiments, the at least one of the arm sections includes a hinge adapted for folding the arm section, and wherein the at least one electrical conductor extends through the hinge. In some embodiments, when the at least one arm section is folded at the hinge, current cannot be conducted through the hinge.
In some embodiments, at least one of the arm sections includes a size-adjustment mechanism, and wherein the electrical conductor extends through the size-adjustment mechanism.
In some embodiments, the headset further includes a power supply, functionally associated with the at least one electrode or with the at least one sensor, providing electrical current to the at least one electrode or to the at least one sensor for operation thereof. In some embodiments, the power supply also being functionally associated with the processing unit for providing electrical current thereto for operation thereof. In some embodiments, the power supply is disposed within or on the anterior section. In other embodiments, the power supply is disposed within or on one of the arm sections.
In some embodiments, the at least one electrode including a stimulating electrode configured to deliver electrical stimulation to a skin surface of the head of the user. In some embodiments, the stimulating electrode is disposed, when the headset is donned, above a nerve or nerve junction and being configured to deliver the electrical stimulation to the nerve or nerve junction. In some embodiments, the stimulating electrode is configured to deliver the electrical stimulation to at least one brain region of the user.
In some embodiments, the at least one electrode includes a sensing electrode configured to sense at least one electrical parameter of a body portion of the user.
In some embodiments, at least one of the at least one electrode includes at least one side electrode mounted on an inner surface of the body member. In some embodiments, the at least one side electrode configured to be disposed, when the headset is donned, above at least one of the zygomaticotemporal nerve and the auriculotemporal nerve of the user. In some embodiments, the at least one side electrode includes a transcranial stimulation electrode configured to be disposed, when the headset is donned, above the temple of the user and anterior to the ear of the user or immediately behind the ear of the user.
In some embodiments, the headset further includes a nose bridge portion, attached to the body member at a center thereof, and positionable on a nose bridge of the user during donning the headset. In some embodiments, the nose bridge portion is removably and replaceably attached to the body member. In some embodiments, the nose bridge portion includes at least one pliable portion adapted to contact the user's nose or nose bridge and to follow the contours thereof.
In some embodiments, the headset further includes at least one of an optical member and an ocular member, attached to the body member at a center thereof, and positionable over eyes of the user during donning of the headset. In some embodiments, the at least one of an optical member and an ocular member is removably and replaceably attached to the body member.
In some embodiments, the headset further includes a nose bridge portion and an optical member, both removably and replaceably attachable to the body member via the same attachment point.
In some embodiments, the at least one sensor includes a spatial orientation sensor configured to sense an angular position of the headset, when donned. In some embodiments, the sensor includes a sensor selected from the group consisting of a temperature sensor, an orientation sensor, a blood pressure sensor, a pulse oximetry sensor, an electrical conductivity sensor, a sensor for measuring skin conductance response (SCR), a sensor for measuring impedance plethysmograph (IPG), a sensor for measuring electroencephalogram (EEG), and a sensor for measuring electromyograph (EMG).
In accordance with some teachings of the present invention there is provided a method of donning a headset on the head of a user, the method including:
In some embodiments, pushing further includes, during motion of the headset rearward, the posterior ends of the arm sections plowing through the hair and clearing an area of the scalp of the user for physical contact of the at least one electrode or the at least one sensor therewith.
In some embodiments, the method further includes, when the body member is in the closed state, adjusting a size of the body member by simultaneously pushing against the anterior section and a section of the body member adjacent the closure mechanism, so as to adjust the length of at least one size-adjustment mechanism of the headset.
In some embodiments the method further comprises, subsequent to pushing the headset rearward, applying pressure to a flexible surface adjacent the at least one electrode and compressing the at least one electrode to release a conductive fluid from the electrode to an area between the at least one electrode and the scalp of the user, thereby to reduce the impedance between the at least one electrode and the scalp.
In accordance with additional teachings of the present invention there is provided an electrode system for stimulation of the anterior portion of the head of a user, the system including a first anterior electrode and a second anterior electrode, each of the first and second anterior electrodes having a first end, a second end, a height, and a length, wherein:
In some embodiments, the first anterior electrode is configured, when the headset is donned, to be disposed above the supratrochlear nerve on one side of the user's head, and the second anterior electrode is configured, when the headset is donned, to be disposed above the supraorbital nerve on the one side of the user's head,
In some embodiments, each of the first and second anterior electrodes includes a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, the first and second anterior electrodes are disposed on a joint substrate, the shared substrate including a first contact portion in electrical contact with the electrode backing of the first anterior electrode and a second contact portion in electrical contact with the electrode backing of the second anterior electrode.
In some embodiments, the ratio between an area of the first anterior electrode and an area of the second anterior electrode is in the range of 0.5-2. In some such embodiments, the area of the first anterior electrode is equal to the area of the second anterior electrode. In some embodiments, a contour of the first anterior electrode is identical to a contour of the second anterior electrode.
In some embodiments, the first and second anterior electrodes extending, at a lower end thereof, along a single concave contour defined between first and second boundary points disposed at opposite ends of the concavity and adapted to generally follow the outline of the user's eyebrows,
A/L≥0.5 mm
H
max
/H
min≤2.5,
In some embodiments, an angle between the line and the second end of the first anterior electrode adjacent the distance is in the range of 40-110 degrees.
In accordance with additional aspects of the teachings herein, there is provided an electrode system for stimulation of the occipital portion of the head of a user, the system including a first posterior electrode and a second posterior electrode, each of the first and second posterior electrodes having a first end, a second end, a height, and a length, wherein:
In some embodiments, the first posterior electrode is configured, when the headset is donned, to be disposed above a first occipital nerve branch on one side of the user's head, and the second posterior electrode is configured, when the headset is donned, to be disposed above a second occipital nerve branch on the one side of the user's head,
In some embodiments, each of the first and second posterior electrodes includes a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, the first and second posterior electrodes are disposed on a joint substrate, the joint substrate including a first contact portion in electrical contact with the electrode backing of the first posterior electrode and a second contact portion in electrical contact with the electrode backing of the second posterior electrode.
In some embodiments, the ratio between an area of the first posterior electrode and an area of the second posterior electrode is in the range of 0.5-2. In some such embodiments, the area of the first posterior electrode is equal to the area of the second posterior electrode.
In some embodiments, a joint contact surface including the contact surfaces of the first and second posterior electrodes has a generally frusto-conical outline defining a base and a curved tip, connected by a pair of side curves, and wherein the first posterior electrode and the second posterior electrode are mirror image symmetrical about a horizontal axis of symmetry. In some such embodiments, a curvature of the tip corresponds to that of a circle having a radius not greater than 10 mm, a curvature of the side curves corresponds to that of a circle having a radius of at least 50 mm, and an angle between the second end of the first posterior electrode and the horizontal axis of symmetry is in the range of 75-105 degrees.
According to some teachings of the present invention there is provided a method for transdermally applying electrical stimulation to a region of the head of a user, the method including:
In some embodiments, when each of the first and the second time ratios is less than the predetermined threshold ratio, the adapting includes increasing the common rest-time value, and when each of the first and the second time ratios is equal to or greater than the predetermined threshold ratio, the adapting includes increasing a voltage provided by the electrodes and decreasing the common rest time value to a predetermined minimum rest-time value.
In some embodiments, the adapting further includes adapting the common phase width.
According to some teachings of the present invention there is provided a method for transdermally applying electrical stimulation to a region of the head of a user, the method including:
In some embodiments, the positive phases in the positive phase train have a common phase width wp. In some embodiments, the negative phases in the negative phase train have a common phase width wn. In some embodiments, the positive phases in the positive phase train and the negative phases in the negative phase train have a common phase width w1.
In some embodiments, rest times between immediate successor phases in the positive phase train have a common rest-time value rtp. In some embodiments, the rest times between immediate successor phases in the negative phase train have a common rest-time value rtn. In some embodiments, the rest times between immediate successor phases in the positive phase train and in the negative phase train have a common rest-time value rt1.
In some embodiments, when each of the first and the second time ratio is less than the predetermined threshold ratio, the adapting includes increasing a duration of the at least one the rest-time, and when each of the first and the second time ratio is equal to or greater than the predetermined threshold ratio, the adapting includes increasing a voltage provided by the electrodes and decreasing a duration of the at least one the rest time to a predetermined minimum rest-time value.
In some embodiments, when each of the first and the second time ratio is less than the predetermined threshold ratio, the adapting includes increasing a duration of each rest-time, and when each of the first and the second time ratio is equal to or greater than the predetermined threshold ratio, the adapting includes increasing a voltage provided by the electrodes and decreasing a duration of each rest time to a predetermined minimum rest-time value.
In some embodiments, the adapting further includes adapting a phase width of at least one the positive phase or at least one the negative phase. In some embodiments, the adapting a phase width includes adapting a phase width of each positive phase and each negative phase.
In some embodiments, a duration of the positive phase train is different from a duration of the negative phase train. In some embodiments, the cumulative duration of the positive phases is different from the cumulative duration of the negative phases. In some embodiments, the cumulative duration of the rest times between the positive phases in the positive phase train is different from the cumulative duration of the rest times between the negative phases in the negative phase train.
In some embodiments, a number of the positive phases in the positive phase train is different from a number of the negative phases in the negative phase train. In some embodiments, a duration of the positive phase train is equal to a duration of the negative phase train. In some embodiments, the cumulative duration of the positive phases is equal to the cumulative duration of the negative phases.
In some embodiments, the cumulative duration of the rest times between the positive phases in the positive phase train is equal to the cumulative duration of the rest times between the negative phases in the negative phase train.
In some embodiments, a number of the positive phases in the positive phase train is equal to a number of the negative phases in the negative phase train.
In some embodiments, the region of the head is a hair covered region of the head. In some embodiments, the engaging includes engaging the electrodes at the hair covered region of the head. In some embodiments, the region of the head includes a cephalic nerve, such that the electrical stimulation is delivered to the cephalic nerve in the region of the head.
In some embodiments, the engaging includes mounting a headset, including the at least two electrodes and the electronic circuit, on the head of the user such that the at least two electrodes engage the surface of the scalp.
In some embodiments, the predetermined threshold ratio is in the range of 0.4-1.2, 0.5-1, or 0.55-0.75. In some embodiments, the predetermined threshold ratio is 0.6.
In some embodiments, a duration of each rest time in the positive phase train and in the negative phase train at least equals a minimum rest time duration. In some embodiments, the minimum rest time duration is 5 μsec.
In some embodiments, a phase width of each of the positive phases and of each of the negative phases is not greater than a maximal phase width. In some embodiments, the maximal phase width is at most 600 μsec, at most 400 μsec, at most 200 μsec, at most 100 μsec, or at most 50 μsec.
In some embodiments, the monitoring is carried out by the electrodes.
In some embodiments, the monitoring is carried out by at least one sensor external to the electrodes, the sensor engaging the skin of the scalp of the user and being functionally associated with the electronic circuit.
In some embodiments, the monitoring includes monitoring a provided waveform for each of the positive and the negative phases, to identify, for each positive and the negative phase, whether the provided waveform is identical to an intended waveform, and wherein the reduction of charge is identified if the provided waveform is not identical to the intended waveform.
In some embodiments, the adapting includes adapting at least one of the first time ratio and the second time ratio. In some embodiments, the adapting includes adapting the first time ratio and the second time ratio.
In some embodiments, the adapting further includes changing a number of the positive phases in the positive phase train. In some embodiments, the adapting further includes changing a number of the negative phases in the negative phase train. In some embodiments, the adapting further includes changing an amplitude of at least one of the positive phases and the negative phases.
In some embodiments, the monitoring further includes the electronic circuit measuring impedance in the electrodes, and wherein the adapting takes place upon identification of the impedance exceeding an impedance threshold.
In some embodiments, the monitoring further includes monitoring a voltage delivered by the electrodes, and wherein the adapting takes place upon identification of the voltage reaching an upper voltage threshold. In some embodiments, the upper voltage threshold is the compliance voltage.
In some embodiments, the method further includes, following the monitoring showing that the predetermined amount of charge has been provided by each of the positive and the negative phases and completion of the step (e), additionally monitoring the amount of charge delivered by the positive and the negative phases, to identify a change in the charge delivered by the positive and the negative phases.
In some embodiments, the change is indicative of a change in conditions in which the positive and the negative phases are provided. In some embodiments, the change in the conditions includes a change in impedance measured between the at least two electrodes.
In some embodiments, the additionally monitoring is carried out periodically.
In some embodiments, the additionally monitoring is carried out intermittently.
In some embodiments, the additionally monitoring is carried out in response to receipt of an indication from the user. In some embodiments, the indication includes an indication of discomfort or pain.
In some embodiments, the additionally monitoring is carried out in response to receipt of a signal from a humidity sensor indicating a change in humidity in an area adjacent the electrodes.
In some embodiments, the additionally monitoring is carried out in response to receipt of a signal from a temperature sensor indicating a change in temperature in an area adjacent the electrodes.
In some embodiments, the additionally monitoring is carried out in response to receipt of a signal from an accelerometer indicating a change in at least one of a position of the user, a position of the electrodes, and pressure applied to the electrodes.
In some embodiments, the additionally monitoring is carried out in response to receipt of a signal from a pressure sensor indicating a change in pressure applied to the electrodes.
In some embodiments, the method further includes, following identification of the change in conditions by the additionally monitoring, repeating the steps (d) and (e) of the method.
In some embodiments, the method further includes, following at least one of the first time ratio and the second time ratio reaching the predetermined threshold ratio and the voltage reaching the predetermined voltage threshold, terminating application of the electrical stimulation, and notifying the user that treatment has been terminated.
In some embodiments, the method further includes, following step (a) and prior to step (b):
In some embodiments, the method further includes, following step (a) and prior to step (b):
In some embodiments, the upper voltage threshold is the compliance voltage of the electronic circuit.
According to some teachings of the present invention there is provided a head mounted device including:
In some embodiments, the processing unit is further programmed:
In some embodiments, the processing unit is further configured to provide input to the electrodes causing adaptation of the common phase width.
According to some teachings of the present invention there is provided a head mounted device including:
In some embodiments, the electrodes are configured to deliver a pulse wherein the positive phases in the positive phase train have a common phase width wp. In some embodiments, the electrodes are configured to deliver a pulse wherein the negative phases in the negative phase train have a common phase width wn. In some embodiments, the electrodes are configured to deliver a pulse wherein the positive phases in the positive phase train and the negative phases in the negative phase train have a common phase width w1.
In some embodiments, the electrodes are configured to deliver a pulse wherein the rest times between immediate successor phases in the positive phase train have a common rest-time value rtp. In some embodiments, the electrodes are configured to deliver a pulse wherein the rest times between immediate successor phases in the negative phase train have a common rest-time value rtn. In some embodiments, the electrodes are configured to deliver a pulse wherein the rest times between immediate successor phases in the positive phase train and in the negative phase train have a common rest-time value rt1.
In some embodiments, the processing unit is further programmed:
In some embodiments, the processing unit is further programmed:
In some embodiments, the processing unit is further programmed to provide input to the electrodes causing adaptation to a phase width of at least one the positive phase or at least one the negative phase. In some embodiments, the processing unit is further programmed to provide input to the electrodes causing adaptation to a phase width of each positive phase and each negative phase.
In some embodiments, the electrodes are configured to deliver a pulse wherein a duration of the positive phase train is different from a duration of the negative phase train. In some embodiments, the electrodes are configured to deliver a pulse wherein the cumulative duration of the positive phases is different from the cumulative duration of the negative phases. In some embodiments, the electrodes are configured to deliver a pulse wherein the cumulative duration of the rest times between the positive phases in the positive phase train is different from the cumulative duration of the rest times between the negative phases in the negative phase train.
In some embodiments, the electrodes are configured to deliver a pulse wherein a number of the positive phases in the positive phase train is different from a number of the negative phases in the negative phase train. In some embodiments, the electrodes are configured to deliver a pulse wherein a duration of the positive phase train is equal to a duration of the negative phase train. In some embodiments, the electrodes are configured to deliver a pulse wherein the cumulative duration of the positive phases is equal to the cumulative duration of the negative phases.
In some embodiments, the electrodes are configured to deliver a pulse wherein the cumulative duration of the rest times between the positive phases in the positive phase train is equal to the cumulative duration of the rest times between the negative phases in the negative phase train. In some embodiments, the electrodes are configured to deliver a pulse wherein a number of the positive phases in the positive phase train is equal to a number of the negative phases in the negative phase train.
In some embodiments, the device further includes a body member adapted to be donned on the head of a user, wherein the electrodes and the sensor are mounted onto an inner surface of the body member.
In some embodiments, the region of the head is a hair covered region of the head. In some embodiments, the electrodes are configured, when the head mounted device is donned, to engage the hair covered region of the head. In some embodiments, the region of the head includes a cephalic nerve, such that the electrodes are configured to deliver the electrical stimulation to the cephalic nerve in the region of the head.
In some embodiments, the predetermined threshold ratio is in the range of 0.4-1.2, 0.5-1, or 0.55-0.75. In some embodiments, the predetermined threshold ratio is 0.6.
In some embodiments, the electrodes are configured to deliver a pulse wherein a duration of each rest time in the positive phase train and in the negative phase train is at least equal to a minimum rest time duration. In some embodiments, the minimum rest time duration is 5 μsec.
In some embodiments, the electrodes are configured to deliver a pulse wherein a phase width of each of the positive phases and of each of the negative phases is not greater than a maximal phase width. In some embodiments, the maximal phase width is at most 600 μsec, at most 400 μsec, at most 200 μsec, at most 100 μsec or at most 50 μsec.
In some embodiments, the at least one sensor is at least one of the electrodes.
In some embodiments, the at least one sensor is external to the electrodes and is functionally associated with the electronic circuit.
In some embodiments, the at least one sensor is configured to monitor a provided waveform of each of the positive and the negative phases, and wherein the processing unit is configured to identify, for each positive and the negative phase, whether the provided waveform is identical to an intended waveform, and to identify the reduction of charge if the provided waveform is not identical to the intended waveform.
In some embodiments, the processing unit is configured to provide to the electrodes instruction for adapting at least one of the first time ratio and the second time ratio. In some embodiments, the processing unit is configured to provide to the electrodes instruction for adapting the first time ratio and the second time ratio.
In some embodiments, the processing unit is configured to provide to the electrodes instructions for changing a number of the positive phases in the positive phase train. In some embodiments, the processing unit is configured to provide to the electrodes instructions for changing a number of the negative phases in the negative phase train. In some embodiments, the processing unit is configured to provide to the electrodes instructions for changing an amplitude of at least one of the positive phases and the negative phases.
In some embodiments, the at least one sensor is configured to monitor impedance in the electronic circuit, and the processing unit is configured to identify the impedance exceeding an impedance threshold.
In some embodiments, the at least one sensor is configured to monitor a voltage delivered by the electrodes, and the processing unit is configured to identify the voltage reaching an upper voltage threshold. In some embodiments, the upper voltage threshold is the compliance voltage.
In some embodiments, following the processing unit identifying that the predetermined amount of charge has been provided by each of the positive and the negative phases and completion of the step (d), the processing unit is configured to receive additional input at least from the at least one sensor and to identify at least one of a change in the charge delivered by the positive and the negative phases and a change in conditions in which the positive and the negative phases are provided.
In some embodiments, the at least one sensor is configured to measure a change in impedance between the at least two electrodes and to provide the measurement to the processing unit as the additional input.
In some embodiments, the device further includes a timer functionally associated with at least one of the processing unit and the at least one sensor, and configured to trigger the at least one sensor to provide the additional input periodically.
In some embodiments, the device further includes a user interface functionally associated with the processing unit, wherein the additional input includes input provided by the user via the user interface. In some embodiments, the additional input includes an indication of discomfort or pain provided by the user.
In some embodiments, the device further includes a humidity sensor functionally associated with the processing unit and configured to sense humidity in an area adjacent to the electrodes, and wherein the additional input includes a signal provided from the humidity sensor to the processing unit, the signal indicating a change in humidity in an area adjacent the electrodes.
In some embodiments, the device further includes a temperature sensor functionally associated with the processing unit and configured to sense a temperature in an area adjacent to the electrodes, and wherein the additional input includes a signal provided from the temperature sensor to the processing unit, the signal indicating a change in temperature in an area adjacent the electrodes.
In some embodiments, the device further includes an accelerometer functionally associated with the processing unit and configured to sense at least one of a position of the user and a position of the electrodes, and wherein the additional input includes a signal provided from the accelerometer to the processing unit, the signal indicating a change in at least one of a position of the user, a position of the electrodes, and pressure applied to the electrodes.
In some embodiments, the device further includes a pressure sensor functionally associated with the processing unit and configured to sense pressure applied to the electrodes, and wherein the additional input includes a signal provided from the pressure sensor to the processing unit, the signal indicating a change in pressure applied to the electrodes.
In some embodiments, the processing unit is further configured, following identification of the change in conditions, to repeat the steps (c) and (d).
In some embodiments, the device further includes a user notification module functionally associated with the processing unit and wherein, following at least one of the first time ratio and the second time ratio reaching the predetermined threshold ratio and the voltage reaching the predetermined voltage threshold, the processing unit terminates application of the electrical stimulation, and the user notification module notifies the user that treatment has been terminated.
In some embodiments, the electrodes are configured to deliver, prior to delivery of the positive phase train and the negative phase train a balanced singular constant-current pulse including a positive phase immediately followed by a negative phase, the positive and negative phases intended to provide a predetermined amount of charge to the head of the user, and the processing unit is configured, prior to delivery of the positive phase train and the negative phase train, to identify that impedance in the electronic circuit during delivery of the singular pulse has reached a predetermined impedance threshold.
In some embodiments, the electrodes are configured to deliver, prior to delivery of the positive phase train and the negative phase train, a balanced singular constant-current pulse including a positive phase immediately followed by a negative phase, the positive and negative phases intended to provide a predetermined amount of charge to the head of the user, and the processing unit is configured to identify, prior to delivery of the positive phase train and the negative phase train that a voltage required to deliver the singular constant current pulse has reached the upper voltage threshold, which, in some embodiments, is the compliance voltage of the electronic circuit.
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Throughout the drawings, like-referenced characters are used to designate like functionalities, but not necessarily identical elements.
In the drawings:
Device and methods are described herein that include a headset with one or more integrated electrodes for applying electrical stimulation to peripheral nerves, cranial nerves, transcranial stimulation of brain regions, and sensing of body parameters. The stimulating may be carried out while monitoring the tissue and adapting the electrical stimulation signal to the user's characteristics and to changes over time. The systems and methods ensure effective electrical stimulation while avoiding damage to scalp tissue as well as discomfort to the user, and operate in a safe and robust fashion.
The inventive headset is a head mounted construction that can be served as a platform for applying electrical stimulation to treat various conditions such as migraine and tension type headaches, cluster headache, fibromyalgia, anxiety, depression, post-traumatic stress disorder (PTSD), anxiety, obsessive compulsive disorder (OCD), insomnia, epilepsy, attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, obesity, multiple sclerosis, Traumatic brain injury (TBI) and stroke. The inventive headset may facilitate motor and cognitive learning and may induce relaxation. The inventive headset may also serve as a platform for various sensors, in order to detect and/or assess various conditions.
The stimulation electrodes and the quality of their contact with the scalp are a fundamental aspect in the provision of neurostimulation and in the functionality of the invented apparatus. Ensuring optimal conductivity between the electrodes and the scalp is essential for proper transfer of the electrical current to the target tissues, which is the basis for an effective treatment. Improper conductivity may result in failure of the therapy, unpleasant sensation and even skin irritation due to “hot spots” of high current density. The inventors have also found that non-invasive application of electrical current to the head region, no matter which indication it is applied for, poses numerous challenges including stimulation in the presence of hair, extremely high sensory sensitivity of the scalp, criticality of robust contact and optimal electrical conductivity between the electrodes and the scalp despite variations in head size and contours, and need for precise placement of the stimulating electrodes above the target nerve branches and brain regions.
Given the fact that contact between the stimulation electrodes and the scalp, and the resulting conductivity, are not always optimal, the inventors have developed a method for compensating for reduced conductivity or increased impedance, for example due to presence of hair, lack of humidity, and the like, while maintaining the user's skin integrity, comfort, and ensuring proper neurostimulation.
Electrical stimulation of a pure sensory nerve elicits radiation of a paresthesia sensation along the distribution of the nerve. The existence of paresthesia at the relevant anatomical area is an indication that effective nerve excitation is taking place. Conversely, absence of paresthesia along the distribution of the nerve during stimulation may reflect an inability to reach effective nerve excitation due to inappropriate stimulation parameters such as excessively low intensity, insufficient current density or charge, or due to other reasons such as inappropriate electrode location or high impedance.
Eliciting paresthesia is an important factor also in the treatment of pain. According to the “Gate-control theory”, activation of large sensory Aβ nerve fibers, which is indicated by the paresthesia sensation, leads to inhibition of small diameter nociceptive Aδ and C fibers and thereby impedes the sensation of pain. As such, it is desirable to maintain the user's sensation of paresthesia during neurostimulation treatment. Several aspects of the present invention relate to methods and techniques that are aimed at ensuring that the electrical current is properly and effectively delivered from the electrodes to the target tissues while keeping the voltage applied to the tissue sufficiently low.
Several aspects of the present invention relate to features that are aimed at ensuring that the electrical current is properly delivered from the electrodes to the target tissues and for treating and assessing the head region in an effective and comfortable manner.
Reference is now made to
As seen, an inventive headset 100 according to an embodiment of the teachings herein may be configured to include an anterior member 112 connected to a pair of flexible arm members 114, which may also be called interim members, each terminating in a posterior member 116. Anterior member 112, flexible arm members 114, and posterior members 116 together form the headset body.
It is appreciated that in some embodiments, the inventive headset may comprise an elongate member formed of a flexible material, and including an anterior section, arm member sections, and posterior sections, without including explicitly identified anterior member, arm members, and posterior members. However, for the ease of description, the following description relates to an embodiment including a clearly defined anterior member, flexible arm members, and posterior members comprising end sections of the arm members.
In some embodiments, anterior member 112 is typically rigid, but in some embodiments may be at least partially flexible, or at least semi-rigid. In some embodiments, the anterior member 112 may be flexible and may include a rigid or semi-rigid member connected thereto, such that a degree of freedom exists between the flexible anterior member 112 and the rigid member connected to it that allows the flexible anterior member 112 to flex. In some embodiments, anterior member 112 may be rigid or semi-rigid, and may house a flexible member therein, such that the flexible member may be able to flex within the anterior member 112, for example as described hereinbelow with reference to
As described in further detail hereinbelow with reference to
It is a particular feature of the teachings herein that arm members 114 are resilient, and have a predefined preload pushing the arm members toward each other, such that when the headset is in the open state, as shown in
Arm members 114 are semi-rigid, and not fully rigid, so as to allow the arm members 114 to conform to the user's head shape and/or to absorb pressure applied to different locations on the arm members without resulting in movement of treating portions of the device, described hereinbelow, from their correct positions. For example, when the user lies down and the side of the user's head is supported, or engages a surface on which the user is lying down, pressure is applied to arm members 114, and the partial flexibility of the arm members absorbs this pressure and ensures that the treating and/or sensing components of headset 100 remain properly positioned.
In some embodiments, each temple arm portion 118 includes a hinge 122, useful for folding the arm members 114 to lie parallel to the anterior member 112, as described hereinbelow with reference to
In some embodiments, each posterior member 116 comprises a terminal portion of the posterior arm portion 119 having a tapered end terminating in a closure mechanism 128, described in further detail hereinbelow with reference to
Anterior member 112 may be configured to contain, or to have removably attached thereto, on an interior surface thereof, one or more anterior electrode systems 130, and each of posterior members 116 may be configured to contain, on an interior surface thereof, one or more posterior electrode systems 140. Each of electrode systems 130 and 140 comprises an electrode base and a disposable electrode unit, which may, in some embodiments, be structured and functional as described hereinbelow with reference to
In some embodiments, electrode systems 130 may comprise anterior electrodes adapted to be located at the supraorbital region of the head, over the trigeminal nerve branches for stimulation thereof, which may be structured and functional as described hereinbelow with reference to
In some embodiments, electrode systems 140 may comprise posterior electrodes adapted to be located at the occipital region of the head, over the occipital nerve branches for stimulation thereof, which may be structured and functional as described hereinbelow with reference to
In some embodiments, one or more of electrode systems 130 and 140 may comprise sensing electrodes, configured to sense at least one electrical parameter of a body portion of said user, such as, for example, electroencephalogram (EEG), skin conductance response (SCR), impedance plethysmograph (IPG), electromyograph (EMG), and the like.
It is appreciated that headset 100 may include additional electrodes, as shown in
Anterior member 112 may be configured to contain an electronic circuit 142, which may be configured to be electrically coupled by conductive wires (not shown) to a power source 144, such as a battery, and to electrodes systems 130 and 140. As described hereinbelow with reference to
In some embodiments, the electronic circuit 142 and/or the battery 144 may be external to headset 100, and/or may communicate remotely with headset 100.
The electronic circuit 142 may be configured to include a stimulation circuit, a microprocessor, a charging circuit and a user interface as described hereinbelow with reference to
The stimulation circuit may be configured to produce biphasic, charged balanced electrical pulses, mono-phasic electrical pulses, and/or direct current stimulation.
According to still further features of the described preferred embodiments, the stimulation circuit may be configured to produce electrical stimulation within an intensity range of 0-60 mA, 0-40 mA, 0-20 mA, 0-18 mA, or 0-15 mA.
According to still further features of the described preferred embodiments, the stimulation circuit may be configured to produce stimulation pulses with a duration of 10-1000 μsec, 50-500 μsec, 100-500 μsec, 100-450 μsec, 150-400 μsec or 200-450 μsec, 130-300 μsec, 130-200 μsec, or 230-300 μsec.
According to still further features of the described preferred embodiments, the stimulation circuit may be configured to produce stimulation pulses at a frequency of 1-20,000 Hz, 1-10,000 Hz, 1-500 Hz, 10-300 Hz, 10-250 Hz, 20-180 Hz, 30-180 Hz or 40-100 Hz.
According to still further features of the teachings herein, headset 100, and specifically the electronic circuit 142, may be suited for applying transcranial electrical stimulation using suitable methods such as Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), and Transcranial Random Noise Stimulation (tRNS), as described hereinabove in the Background section.
Specifically, use of a headset for transcranial electrical stimulation requires a higher depth of penetration of the stimulation current through tissues of the head in order to directly affect brain regions. In order to achieve such deeper current penetration, combinations of electrodes located distantly to one another may be activated simultaneously. For example, an anterior electrode may be activated simultaneously with a posterior electrode. Additionally, the locations of the electrodes may be modified so as to increase the distance between adjacent electrodes, thereby to provide deeper penetration of current.
According to still further features of embodiments of the teachings herein, headset 100 may be configured to connect to an external electronic circuit and/or stimulation circuit, and thereby to transfer electrical current from an external stimulator to the electrode systems 130 and/or 140. In some embodiments, headset 100 may be configured to connect to at least one external electrode that may be located at various areas of the body. In some embodiments, headset 100 may be configured to connect to an external electronic circuit and processor in order to transfer signals from sensors disposed on the headset 100 to the external processor.
In some embodiments, battery 144 may be disposed within anterior member 112, and may be recharged by plugging a charger into charging port 146 located, according to certain embodiments, on anterior member 112.
Anterior member 112 may also be configured to include, on an external surface thereof, user controls and interface 150. That said, in some embodiments, other portions of the inventive headset 100, such as posterior members 116 or arms 114, may be configured to include user interface 150. In some embodiments, user interface 150, or an additional user interface (not shown) may be external to headset 100 and may communicate with headset 100 remotely, using wired or wireless communication, as explained hereinbelow with reference to
As explained hereinabove, electronic circuit 142 and user interface 150 are configured to control and/or activate electrodes included in headset 100. In some embodiments, user interface 150 is configured to control and/or activate at least two, and in some embodiments more than two, pairs of electrodes. As such, in some embodiments, the stimulation circuit and/or user interface 150 are configured to enable activation of a specific electrode or of a specific pair, or channel, of electrodes, as well as adjustment of the intensity of current supplied by the activated electrodes or of other stimulation parameters of the activated electrodes. In some embodiments, any subset of the electrodes may be activated simultaneously, and in some embodiments specific subsets are predefined, for example during manufacture of the electronic circuit 142. In some such embodiments, user interface 150 enables control not only of a specific electrode or of a specific channel, but also of activated subsets of the electrodes.
In some embodiments, user controls and interface 150 includes a pair of anterior intensity buttons 151a and 151b for respectively increasing and decreasing the intensity of stimulation provided by anterior electrode systems 130, and a pair of posterior intensity buttons 152a and 152b for respectively increasing and decreasing the intensity of stimulation provided by posterior electrode systems 140. It is appreciated that user control and interface 150 may include similar intensity buttons for each electrode included in the headset 100.
The user controls and interface 150 may further include a mode changing button 154 for activating and disabling the electronic circuit 142, as well as for changing between modes of operation of headset 100. For example, headset 100 may have multiple preset modes of operation, such as a sleep mode, a maintenance mode, and a treatment mode, and repeated operation of button 154 may switch between these modes, in addition to turning the headset on and off.
A user indication button, for example allowing the user to provide a user indication of pain, discomfort, or reduced paresthesia, may form part of user controls and interface 150 and may be disposed on an exterior surface of anterior member 112.
An operation indicator 156, such as an LED light, may form part of user controls and interface 150 and may be disposed on an exterior surface of anterior member 112. Indicator 156 may indicate to a user when the headset 100 is turned on and/or when the electrode systems 130 and/or 140 are active, thereby helping the user prevent unwanted contact with the electrodes when these are operative.
In some embodiments, the user controls and interface 150 may further include an audio element (not shown), such as a speaker or buzzer, for providing to the user an audible indication of use of the headset 100, such as an indication of activation of the headset, shutting down of the headset, pressing a button on interface 150, changing the stimulation mode, and the like.
In some embodiments, the user controls and interface 150 may further include at least one positioning indicator 158, for example in the form of notches in the center of anterior member 112. The positioning indicator 158 assists the user in donning the headset correctly by providing verification for headset placement, for example by helping the user confirm that the positioning indicator 158 is aligned with the user's nose.
As explained hereinabove, the electronic circuit and the user interface are configured to control and/or activate electrodes included in headset 100. In some embodiments, the user interface is configured to control and/or activate at least two, and in some embodiments more than two, pairs of electrodes. As such, in some embodiments, the stimulation circuit and/or the user interface are configured to enable activation of a specific electrode or of a specific pair, or channel, of electrodes, as well as adjustment of the intensity of current supplied by the activated electrodes or of other stimulation parameters of the activated electrodes. In some embodiments, any subset of the electrodes may be activated simultaneously, and in some embodiments specific subsets are predefined, for example during manufacture of the electronic circuit. In some such embodiments, the user interface enables control not only of a specific electrode or of a specific channel, but also of activated subsets of the electrodes.
As seen from comparison of
Turning specifically to
Nose bridge support member 170 may also be configured to further support anterior member 112 against gravity, thereby enabling the user to more easily don headset 100 and preventing the anterior member 112 from applying pressure, in a downward direction, on the eyebrows of the user.
In some embodiments, nose bridge support member 170 is removably and replaceably attached to anterior member 112 by one or more tabs 174, configured to be inserted into corresponding slots in anterior member 112, and may be detached from the anterior member 112 by pulling tabs 174 out of the slots in which they are housed. In some embodiments, the slot for housing tab 174 is located at the center of anterior member 112.
A nose bridge support member 170 of various sizes and shapes may be selected for individual users. In some embodiments, nose bridge support member 170 is sufficiently flexible and/or pliable so as to allow the user to manually adjust the nose bridge for optimal adjustment to the nose of the user.
Reference is now made to
A seen in
As described in further detail hereinbelow with reference to
Reference is now made to
As seen in
In some embodiments, the preload force applied onto the user's head by closure mechanism 128 or the ends of headset 100 may be defined by the following ratio:
P˜EID/L
3 (1)
As illustrated in
Turning additionally to
It is a particular feature of the present invention that the curvature of the posterior arm portions 119 of arm members 114 is affected by contact of the arm members with the sides of the user's head, such that the curvature can be defined by a second imaginary circle partially circumscribed by the arm member and similar to circle 206 of
It is a further feature of the present invention that the curvature of the posterior arm portions 119 of arm members 114 is such that, when the closure mechanism 128 engages the sides of the head of the user, an angle α1 is formed between the ends of headset 100 and the head of the user. As described in further detail hereinbelow with reference to
Turning to
As the user pushes the headset 100 in a rearward direction, due to the engagement between the user's scalp and closure mechanism 128, a change occurs to the curvature of the arm members 114, the angle between the arm members 114 and the user's head, and the force applied to the user's head. Specifically, due to the fact that arm members 114 return toward each other along the curvature of the user's head, the force applied to the user's head in the direction indicated by arrow 208 and computed using ratio (1) above is less than the force applied at the beginning of the donning stage, shown in
Additionally, the curvature of the posterior arm portions 119 of arm members 114 is affected by the rearward movement of the headset 100, and can be defined by a third imaginary circle partially circumscribed by the arm member and similar to circle 206 of
In some embodiments, when both parts of the closure mechanism 128 are in close proximity to one another, the two portions of closure mechanism 128 attract one another to close of headset 100, without requiring the user to actively close the headset 100 or manipulate the closure mechanism 128.
In
In some embodiments, in which closure mechanism 128 is a magnetic closure mechanism as described hereinbelow with reference to
When the headset 100 is donned for the first time, the user may reduce the length of the headset and adjust its size by pushing the posterior arm portions 119 and the anterior member 112 toward one another until the headset is tightened on the user's head, such that the length of size adjustment mechanisms 120 changes and thereby the size of the headset 100 is adjusted to the size of the user's head.
Additionally, in some embodiments, pressure applied to the anterior member 112 by tightening of the headset 100 around the user's head allows compressible components of the anterior member to compress as described hereinbelow with reference to
Such radial pressure on anterior member 112 and on posterior members 116, which pushes them toward the user's head, ensures that the anterior and posterior electrode systems 130 and 140 maintain their suitable positions and remain in close contact with the user's skin. Specifically, in some embodiments, the radial pressure PR applied by the headset 100 on the user's head is in a direction indicated by arrow 212, and may have a force magnitude which is greater than 0N, 1.0N, or 3.0N.
When the headset is in the closed position on the user's head, as shown in
As described hereinabove, in some embodiments, additional electrode systems may be used to stimulate other nerves or nerve junctions, such as the zygomaticotemporal nerve and the auriculotemporal nerve (
Reference is now made to
As seen, in some embodiments anterior member 112 includes a compressible portion 214, here shown as a compressible gasket surrounding the anterior electrode systems. In the rest state, or when the headset is not donned by the user and pressed against his forehead, the compressible portion extends radially inward from anterior member 112, and has a first radial depth, indicated in
In some embodiments, the degree to which the compressible portion 214 is compressed when the headset 100 is donned, contributes to adjustment of the circumference of headset 100.
It is appreciated that there are many ways to construct a suitable compressible portion 214. For example, compressible portion 214 may be formed of a flexible and/or resilient rim or sealing arrangement surrounding the anterior electrode system 130, for example as shown in
As another example, compressible portion 214 may include electrode systems 130 that are mounted on a sponge, elastomer, or other compressible material or construction, such that when the anterior member 112 is pressed against the user's head, the sponge or other compressible construction is compressed, and the radial pressure on the user's forehead increases.
Another exemplary structure of compressible portion 214 is shown in
It is further appreciated that a compressible portion 214 according to the teachings herein need not necessarily form part of the anterior member, and may be placed in any location on the headset which is adapted to engage the user's skin, such as in posterior members 116 and/or along arm member 114.
Reference is now made to
Electrode base housing 240 may be configured to include an electrically conductive material defining a contact portion 244 disposed at least partially above, or within the floor 242 of electrode base housing 240. The conductive layer is adapted to be electrically coupled to an electric circuit by conductive wire 238 and may function as a contact point for the disposable electrode unit 232.
Electrode unit 232 may be configured to be releasably coupled (physically and electrically) to electrode base housing 240.
The electrode unit 232 is a multi-layer unit, which may include liquid absorbent layer, or pad, 246, and a flexible electrically conductive backing layer 248, preferably made of a carbon foil. The two layers may be attached or directly attached. Various manufacturing processes may be used, including heat welding, RF welding, ultrasonic welding, gluing or sewing. In some embodiments, in order to reduce current density at the edges of liquid absorbing layer 246, conductive backing layer 248 may be configured to have a smaller area or “footprint” than layer 246. Consequently, the current density at the edges of layer 246 (which has a lower electrical conductivity with respect to layer 248) will be reduced.
Conductive backing layer 248 may further include a thin electrically conductive layer 250 of conductive paint, which may be printed in a “mesh” pattern and may be configured to cover only the central portion of layer 248. Conductive paint layer 250 may preferably be printed on the bottom surface of layer 248 and may be configured to face contact portion 244 of electrode base housing 240 so as to be electrically coupled when multi-layered electrode unit 232 is attached to electrode base housing 240. Conductive paint layer 250 may be configured to have a higher electrical conductivity compared to layer 248, such that current dispersion over layer 248 is improved while reducing current density at the edges of layer 248.
In some embodiments, the disposable electrode unit 232, including pad 246, may be provided to the user dry, and the user may soak pad 246 with water, saline, conductive gel, or other suitable liquid before use. In other embodiments, the electrode pad 246 of disposable electrode unit 232 may be pre-soaked with conductive gel, such that the gel is mostly absorbed in the pad, and the user need not soak the pad at all. The conductive gel may be any commercially available conductive gel suitable for use with electrodes. It is appreciated that use of conductive gel improves conductivity and reduces dehydration of the pad 246, and that pre-soaked pads 246 may be easier and less messy for the user to handle. In some embodiments, the pad 246 may comprise a self-adhesive hydrogel layer.
Electrode pad 246 of disposable electrode unit 232 may be configured to receive (sense) electrical current or other bio-signals from the skin surface, such as for example electroencephalogram (EEG) and either transfer it via the headset circuit to an electronic circuit that includes a microprocessor or transmit it wirelessly to a remote unit.
As mentioned above, electrode unit 232 may be disposable and may be conveniently replaced by the user.
Electrode unit 232, and particularly electrode pad 246, may be configured to include a peripheral edge 256 that is thinner than the central area of pad 246. Peripheral edge 256 can be made by various manufacturing process such as ultrasonic welding, RF welding or heat compression. By inserting the thin edge 256 into a corresponding groove 252 in housing 240, electrode pad 246 can be reversibly physically coupled to housing 240 and electrically coupled to contact portion 244.
Electrode unit 232 may be configured to have larger area compared to housing 240. It can therefore be squeezed into housing 240 in order to be reversibly (physically an electrically) coupled to housing 240.
Electrode base housing 240 may be configured to include a conducting mechanical snap connector configured to be both physically and electrically reversibly coupled to a corresponding connector attached to electrode unit 232.
Perspective views of an electrode base 234 with and without an inventive, multi-layered disposable electrode unit 232 are provided in
Additional Electrode configurations are described in PCT Application Publication Number WO2014/141213, entitled “HEADSET FOR TREATMENT AND ASSESSMENT OF MEDICAL CONDITIONS”, which is hereby incorporated by reference as if fully set forth herein.
Reference is now made to
As seen in
In some embodiments, the dimensions and spatial relationship of electrode pads 274a and 274b are substantially as described hereinbelow with reference to
An angle γ characterizes the angular placement of the electrode pair 274a, 274b relative to an axis of symmetry of the disposable electrode unit 272, indicated by reference numeral 275. Angle γ is defined between a line connecting two boundary points of the contour 277 at the base of the electrode pair 274a, 274b, similar to line K of
As mentioned hereinabove, the distance D between the two pairs of electrodes 274a, 274b, may be in a range of 4-35 mm, 6-25 mm, or 8-15 mm.
It is appreciated that mounting of multiple electrode pads on a single electrode substrate ensures that the relative distances and angular relationships between the electrodes are maintained, even if the electrodes need to be squeezed into the electrode base, for example as described hereinabove with reference to
Though the electrode unit 272 shown in
Reference is now made to
As seen in
In the illustrated embodiment, the electrode unit 282 includes a single substrate and a pair of electrode pads 284, adapted to stimulate trigeminal nerves in the supraorbital region of the user's head. However, in some embodiments, the electrode unit 282 may include more than two electrodes, for example similar to electrode unit 272 described hereinabove with reference to
In some embodiments, the single electrode housing 280 may receive one or more disposable electrode units, each including one or more electrode pads, and need not necessarily receive only an electrode unit perfectly suited to the contours of housing 280.
Reference is now made to
As seen in
In some embodiments, the degree to which the flexible portion 1214 is extended when the headset 100 is donned, contributes to adjustment of the circumference of headset 100.
It is appreciated that there are many ways to construct a suitable flexible portion 1214, one of which is described hereinbelow with reference to
It is further appreciated that a flexible portion 1214 according to the teachings herein need not necessarily form part of the anterior member 112, and may be removably connectable thereto, for example using a snap fit connection, or may be placed in any location on the headset which is adapted to engage the user's skin, such as in posterior members 116 and/or along arm member 114.
Turning now to
Electrode housing 1240 includes side walls 1242 arranged about the circumference of leaf 1216, and an anterior wall portion 1244 arranged at an anterior portion of the electrode system 1230 and adapted to engage the skin of the user, when the electrode system is in use, as seen in
The electrode housing 1240, and specifically the cavities 1248, are adapted to retain fluid released from electrode units 1232 when the leaf 1216 is extended and the electrode system 1230 is compressed against the user's forehead, as shown in
Flexible leaf 1216 may include an electrically conductive material defining a contact portion 1254 disposed at least partially above, or within the leaf 1216. The conductive layer is adapted to be electrically coupled to an electric circuit by the conductive wire (not shown) and may function as a contact point for the electrode unit 1232.
Electrode unit 1232 may be configured to be releasably coupled (physically and electrically) to leaf 1216 within electrode housing 1240.
The electrode unit 1232 is a multi-layer unit, which may include liquid absorbent layer, or pad, 1256, and a flexible electrically conductive backing layer 1258, preferably made of a carbon foil, substantially as described hereinabove with reference to
In some embodiments, the electrode unit 1232 is disposable, and together with pad 1256, may be provided to the user dry, and the user may soak pad 1256 with water, saline, conductive gel, or other suitable liquid before use. In other embodiments, the electrode pad 1256 of disposable electrode unit 1232 may be pre-soaked with conductive gel, such that the gel is mostly absorbed in the pad, and the user need not soak the pad at all. The conductive gel may be any commercially available conductive gel suitable for use with electrodes. It is appreciated that use of conductive gel improves conductivity and reduces dehydration of the pad 1256, and that pre-soaked pads 1256 may be easier and less messy for the user to handle. In some embodiments, the pad 1256 may comprise a self-adhesive hydrogel layer.
Electrode pad 1256 of electrode unit 1232 may be configured to receive (sense) electrical current or other bio-signals from the skin surface, such as for example electroencephalogram (EEG) and either transfer it via the headset circuit to an electronic circuit that includes a microprocessor or transmit it wirelessly to a remote unit.
As mentioned above, in some embodiments, electrode unit 1232 may be disposable and may be conveniently replaced by the user. In some embodiment the contact portion 1254 and/or the backing layer 1258 may be fixed to leaf 1216, whereas in other embodiments one or both of these layers may be attached to pad 1256 and may be replaced therewith by the user. In some such embodiments, leaf 1216 may be configured to include a conducting mechanical snap connector configured to be both physically and electrically reversibly coupled to a corresponding connector attached to electrode unit 1232.
In some embodiments, the electrode units 1232 are permanently attached to electrode housing 1240, and the electrode units 1232 together with housing 1240 are disposable and designed to be replaced by the user after each use or after several uses. In some embodiments, the entire flexible portion 1214, including the leaf 1216 and the electrode system 1230 are disposable, and are designed to be replaced by the user after each use.
Reference is now made to
Electrode 260 may be configured to have a conductive contact surface with the following dimensions:
Typically, A/L is at least 0.5 mm,
H
max
/H
min≤2.5
The distance between two electrodes 260 configured to stimulate the supraorbital region may be in a range of 4-35 mm, 6-25 mm, or 8-15 mm.
Each of electrode 270a and 270b may include a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface of the user, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected, in an operational mode, with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, in addition to the existing layers, electrodes 270a and 270b also share an additional non-conductive electrode substrate, the substrate including two contact portions each in electrical contact with the electrode backing of one of electrodes 270a and 270b, substantially as described hereinabove with reference to
Electrodes 270a and 270b each have a first end, a second end, a height, and a length, such that the heights of electrodes 270a and 270b, at a maximal point thereof (DN), are in the range of 10 mm to 40 mm, 12 mm to 36 mm, or 20 to 33 mm.
The electrodes 270a and 270b are configured to be arranged, when disposed adjacent the user's skin, horizontally alongside one another, such that a second end 271a of the first electrode is adjacent, and in some embodiments parallel to, a first end 271b of the second electrode with a distance S therebetween, S being in the range of 1-15 mm, 2-10 mm, or 4-8 mm.
A length (DL) consisting of the length of electrode 270a, the length of electrode 270b, and distance S, is in the range of 20 mm to 55 mm, 25 to 50 mm, or 30 to 45 mm. In some embodiments, the area A1 of electrode 270a is equal to the area A2 of electrode 270b. In other embodiments, the ratio of the areas A1/A2 is in the range of 0.5-2, 0.7-1.5, or 0.8-1.25.
In some embodiments, electrodes 270a and 270b, together, may be defined at a lower end thereof along a single concave contour E having a concavity defined by boundary points F and G, which points are disposed at opposite ends of the concavity, the concavity generally following the outline of the user's eyebrows, such that:
As discussed hereinabove, a line disposed between a first point on the concave contour and a second point on the perimeter of one of electrodes 270a or 270b, on a side opposite to concave contour E, and aligned in perpendicular fashion with respect to contour E at the first point, has a length H, and wherein, over an entirety of the concave contour of both electrodes 270a and 270b,
H
max
/H
min≤2.5
An angle β, defined between edge 271a of electrode 270a and line K, is in the range of 45-110 degrees, 70-90 degrees, or 75-85 degrees. β characterizes the angle of edge 271a relative to the base of the electrode.
It is appreciated that in some embodiments, electrodes 270a and 270b, taken together, may suitable for use in a single anterior electrode system 130 as shown in
The distance between two pairs of electrodes 270a and 270b configured to stimulate the supraorbital region may be in a range of 4-35 mm, 6-25 mm, or 8-15 mm.
Each of electrodes 1270a and 1270b may include a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface of the user, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected, in an operational mode, with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, in addition to the existing layers, electrodes 1270a and 1270b also share an additional non-conductive electrode substrate, the substrate including two contact portions each in electrical contact with the electrode backing of one of electrodes 1270a and 1270b, substantially as described hereinabove with reference to
In some embodiments, electrodes 1270a and 1270b have a substantially identical contour, and are merely rotated relative to one another to form the general contour shown in
The electrodes 1270a and 1270b are generally trapezoidal, where corners of the trapezoid are replaced by curves. As such, each electrode includes a first end or base 1272, a second end or base 1274, a first side 1276, and a second side 1278, a height (defined between the first and second sides), and a length (defined between the first and second bases).
The length of electrodes 1270a and 1270b, at a maximal point thereof (DN), is in the range of 10 mm to 40 mm, 15 mm to 30 mm, or 20 to 25 mm. The height of the electrodes 1270a and 1270b is such that a minimal height Hmin defined between the first and second sides adjacent the first base, and a maximal height Hmax defined between the first and second sides adjacent the second base, fulfill the formula
H
max
/H
min≤2.
The electrodes 1270a and 1270b are configured to be arranged, when disposed adjacent the user's skin, horizontally alongside one another, such that a second base 1274a of the first electrode is adjacent, and in some embodiments parallel to, a first side 1276b of the second electrode with a distance S therebetween, S being in the range of 1-15 mm, 2-10 mm, or 4-8 mm. The parallel arrangement of second base 1274a and first side 1276b prevents the formation of areas of increased current density between the electrodes.
A length (DL) consisting of the length of electrode 1270a, a width of electrode 1270b, and distance S, is in the range of 20 mm to 55 mm, 25 to 50 mm, or 30 to 45 mm. In some embodiments, the area A of electrodes 1270a and 1270b are equal.
An angle β, defined between second base 1274a and second side 1278a of electrode 1270a, is in the range of 45-110 degrees, 70-90 degrees, or 75-85 degrees. β characterizes the angle of second side 1278a relative to the base 1274a of the electrode. It is appreciated that electrodes 1270a and 1270b may be side to side symmetrical, such that also β characterizes the angle of first side 1276a relative to the base 1274a of the electrode.
It is appreciated that in some embodiments, electrodes 1270a and 1270b, taken together, may suitable for use in a single anterior electrode system 130 as shown in
The distance D between two pairs of electrodes 1270a and 1270b configured to stimulate the supraorbital region may be in a range of 4-35 mm, 5-25 mm, or 6-15 mm.
Additional electrodes may be located on the headset in order to stimulate other nerves, for example, the zygomaticotemporal nerve or the auriculotemporal nerve at the sides of the head or to stimulate the temporal brain region. The headset may also include electrodes that are configured to stimulate the occiput region, as described further hereinbelow with reference to
Reference is now made to
As seen in
Electrode system 740 typically includes an electrode pad 746, which is adapted to electrically engage, a conductive backing layer 748, substantially as described hereinabove with reference to
Disposed on outer surface 702, typically at a location parallel to the location of contact 744 on inner surface 704, is a pressure location guide 706 configured to guide a user wearing the headset as to a suitable location for applying pressure to the posterior electrode. In some embodiments, the pressure location guide 706 is textured, such that the user can tactilely feel its location at the posterior portion of the user's head when the headset is donned.
When the headset is in its rest state, or is not donned by the user, the electrode system 740 engages the entire inner surface 704 of the electrode housing 700, as illustrated in
Following donning of the headset as described hereinabove, when the electrode system 740 is placed beneath the hair of the user at the posterior of the user's head, the user applies pressure to the electrode housing 700 at the location indicated by pressure location guide 706, in a direction indicated by arrow F in
Due to the flexible nature of the electrode housing 700, pressure applied by the user at pressure location guide 706 results in deformation of the electrode housing 700 and in compression of the electrode pad 746 to a thickness of A′, as seen in
The pressure applied by the user, together with the compression of the electrode pad 746, results in release of a conductive fluid, such as a water, saline, or conductive gel, from the electrode pad 746 into a gap between the electrode system 740 and the hair and/or scalp of the user. The released liquid reduces the impedance between the electrode system 740 and the scalp, which is caused by the presence of hair therebetween, and thus improves the efficacy of the treatment.
In some embodiments, the electrode housing 700 is not entirely formed of a flexible material, but rather include a layer formed of a flexible material, to which pressure is applied by the user.
In some embodiments, a rigid layer is disposed between the flexible electrode housing 700 or a flexible layer thereof and the electrode system 740. In such embodiments, pressure is applied by the user to the flexible electrode housing or to the flexible layer, and the pressure is distributed throughout the rigid layer resulting in the electrode backing 748, mounted onto the rigid layer, being in contact with an entire surface of the electrode pad 746. Additionally, more homogenous pressure may applied to the electrode pad 746. In such embodiments, the contact 744 and/or the electrode backing 748 is disposed on the rigid layer.
Reference is now made to
Electrodes 290, 291a, and 291b may include a liquid-absorbent layer having a biocompatible contact surface, the contact surface adapted to be juxtaposed against the skin surface of the user, and an electrode backing, attached to the liquid-absorbent layer, the backing containing at least one electrically conductive material or element, the conductive material or element being electrically connected, in an operational mode, with the liquid-absorbent layer, when the liquid-absorbent layer is filled with liquid.
In some embodiments, electrodes 291a and 291b may both be attached to an additional, common non-conductive, electrode substrate layer the substrate including two contact portions each in electrical contact with the electrode backing of one of electrodes 291a and 291b.
Each of electrodes 290, 291a, and 291b is mirror-image symmetrical about a horizontal axis of symmetry 292.
Turning specifically to
In some embodiments, the curvature of curved tip 294 may be defined by an imaginary circle, partially circumscribed within curved tip 294, the imaginary circle having a radius R not greater than 10 mm, not greater than 8 mm, or not greater than 6 mm.
In some embodiments, the curvature of curves 295 may be defined by a second imaginary circle, partially circumscribed within each of curves 295, the imaginary circle having a radius R1 of at least 50 mm, at least 100 mm, or at least 150 mm.
Turning to
The dimensions L, H1, H2, R, and R1 shown in
As seen, the edges 296 of electrodes 291a and 291b which are adjacent one another may be parallel, and have a distance S therebetween, S being in the range of 1-10 mm, 2-8 mm, or 4-6 mm. It is appreciated that distance S may, in some embodiments, be selected to be suitable for each of electrodes 291a and 291b to stimulate a different one of the occipital nerve branches.
An angle θ, defined between edge 296 of electrode 291a and axis of symmetry 292, is in the range of 75-105 degrees, 80-100 degrees, or 85-95 degrees. The angle θ characterizes the angle at which the electrodes are split.
In some embodiments, the area A1 of electrode 291a is equal to the area A2 of electrode 291b. In other embodiments, the ratio of the areas A1/A2 is in the range of 0.5-2, 0.7-1.5, or 0.8-1.25.
It is appreciated that in some embodiments, electrodes 291a and 291b, taken together, may be suitable for use in a single posterior electrode system 140 as shown in
Reference is now made to
As mentioned hereinabove with reference to
Turning specifically to
In some embodiments, the dimensions A, B, C, and D are selected such that the total circumference of headset 100, which is given by the formula 2(A+B+C′)+D is smaller than 700 mm, 680 mm, or 660 mm.
As discussed hereinabove with reference to
It is appreciated that the resilience of the temple arm portion 118 provides at least some of the flexibility and resilience required in order to drive the arm members 114 toward the axis of symmetry after they are pulled outwardly. The degree of flexibility of temple arm portion 118 affects the distance to which arm members 114 may be outwardly displaced, such that more flexible temple arm portions 118 allow for greater displacement of arm member 114. It is appreciated that in embodiments in which anterior member 112 is also flexible or semi-flexible, the flexibility thereof may also contribute to the extent to which arm members 114 may be outwardly displaced.
The length A of posterior arm portions 119 is selected such that it will be adapted to span the entire rear portion of the user's head, regardless of the size of the user's head. Specifically, if posterior arm portions 119 are too short, the headset 100 may be not able to close on a person with a large head. Additionally, if posterior arm portions 119 are too short, they may not be able to align with the contour of the rear portion of the user's head while donning the headset, and thus the angle α (
The size adjustment mechanism 120 may be any suitable size-adjustment mechanism, such as, for example, a slidable mechanism or a ratchet mechanism as known in the art. The length B of size adjustment mechanism 120, as well as the extent to which size adjustment mechanism 120 can change the length of arm member 114 is selected so as to enable a suitable range of circumferences of the headset, while ensuring that the circumference of headset 100, in the closed state, will be fitted to the circumference of the user's head.
Turning to
It is appreciated that in embodiments such as that shown in
It is appreciated that in embodiments such as that shown in
As seen in
In some embodiments, the width A of posterior member 116 at its widest point is not greater than 40 mm, not greater than 30 mm, or not greater than 20 mm. In some embodiments, the length of posterior member 116, indicated by L, is not greater than 100 mm, not greater than 80 mm, not greater than 60 mm, or not greater than 50 mm. In some embodiments, the length of posterior member 116, indicated by L, is not less than 5 mm, not less than 10 mm, or not less than 20 mm.
It is appreciated that in embodiments in which posterior member 116 has an electrode system disposed thereon, such as that illustrated in
It is further appreciated that in some embodiments, such as embodiments in which posterior member 116 includes an electrode system, the tapering of the width of posterior member 116 need not be linear along the length of the posterior member, and/or the posterior member need not be tapered along the entirety of its length. For example the posterior member may include an electrode portion having a fixed width or tapering very slightly, and may taper at a greater angle in a second portion, distal to the electrode, to reach width A′ at the closure mechanism.
Reference is now made to
It is appreciated that a magnetic closure mechanism 128 is advantageous over use of other types of closure mechanisms, as the two portions of the closure mechanism may attract one another and thus close without requiring the user donning headset 100 to directly interact with or manipulate closure mechanism 128. This is particularly useful in the donning method of the inventive headset 100, since the user's hands typically hold the headset at side portions thereof during the donning process, as shown in
One magnetically attractable portion 300a includes a pin 302, whereas the other magnetically attractable portion 300b includes a bore 304 suitable for housing pin 302. Magnetically attractable portions 300 are arranged so as to attract one another when disposed adjacent one another, thereby directing pin 302 to engage bore 304 and to secure the headset on the user's head. In some embodiments, not shown in
In some embodiments, the magnetically attractable portions 312 comprise a section of a sphere, such as a spherical cap or half a sphere. In other embodiments, the magnetically attractable portions 312 comprise a sphere. In some embodiments, the spherical surface of the magnetically attractable portions 312 has a radius in the range of 2 to 20 mm, in the range of 3 to 15 mm, or in the range of 4-10 mm. In some embodiments the holding force of one or more magnets of magnetically attractable portions 312 is in the range of 0.5 to 15 N, in the range of 1 to 10 N, or in the range of 1.5 to 7 N.
Magnetically attractable portions 312 are adapted to engage one another at the spherical surface thereof, thereby to close headset 100. Due to the spherical shape of the engagement surface of magnetically attractable portions 312, the contact point between the two magnetically attractable portions 312 is minimal and is substantially a single point, thereby preventing pinching of the user's hair within the closure mechanism 128.
In some embodiments, magnetically attractable portions 312 are rotatable within housing 310 and are arranged so as to attract one another when disposed at a small distance from one another so as to make it easier for the user to close the headset 100 while donning the headset, without seeing the closure mechanism 128, as explained hereinabove with reference to
It is appreciated that any suitable closure mechanism may be used for securing headset 100 so that it does not fall or move when donned. However, it is a particular feature of the teachings herein that in all of the embodiments illustrated in
Reference is now made to
Reference is now made to
As seen, and as discussed hereinabove with respect to
It is appreciated that in certain embodiments, particularly ones in which the power supply and/or the processing unit of headset 100 are disposed in anterior member 112 and need to provide power and/or processing instructions to posterior electrodes 140, electric conductors must extend along at least one of arm members 114 through at least one hinge portion 320.
In some such embodiments, the a first electrical conductor 330 electrically connected to anterior member 112 terminates, at the first end surface 324 in a metal contact bore 332, and a second electrical conductor 334 electrically connected to posterior member 116 terminates, at second end surface 326 of arm member 114, in a metal contact pin 336.
As illustrated in
Reference is now made to
As discussed hereinabove with reference to
In some embodiments, the size adjustment mechanism 120 comprises a sliding and/or ratcheting adjustment mechanism, including a slot 340 formed in temple arm portion 118, and a flexible arm portion 342 extending from posterior arm portion 119 and disposed within slot 340 and slidably movable therein.
A first, flat electrical conductor 344, extends from anterior member 112, along temple arm portion 118 and along slot 340. A second electrical conductor 346 extends along posterior arm portion 119 and along flexible arm portion 342 thereof, and terminates in a contact spring 348 within slot 340, such that contact spring 348 is in electrical contact with flat electrical conductor 344 within the slot. Thus, electrical conduction through size adjustment mechanism 120 is accomplished by electrical contact between the flat electrical conductor 344 and the contact spring 348, regardless of the position of flexible arm portion 342 within slot 340.
It is appreciated that any other mechanism for conducting electricity through the size adjustment mechanism 120 is also considered within the scope of the invention, provided that current can be transferred from the anterior member 112 to the posterior member 116 without causing harm or risk to the user.
Reference is now made to
Eyeglasses 380 may be configured to be located in the central area of anterior member 112. Positioning the eyeglasses 380 over the nose and eyes may allow the user to determine the rotational and longitudinal placement of headset 100, for example while donning the headset.
Eyeglasses 380 may also be configured to further support anterior member 112 against gravity, thereby enabling the user to more easily don headset 100, substantially as described hereinabove with reference to nose bridge 170 of
In some embodiments, eyeglasses 380 may comprise optical lenses for improved eyesight, dark lenses suitable to be used as sunglasses, non-optical transparent lenses, or highly dark lenses that may be used to block external light, for example, in order to assist during migraine attack or for relaxation.
It is appreciated that in some embodiments, eyeglasses 380 may be replaced with any suitable optical or ocular element, such as goggles and the like.
In some embodiments, headset 100 may be configured to communicate wirelessly with remote control 560. Remote control 560 may be used by the user to send commands to headset 100, such as stimulation initiation or cessation commands, or commands to increase or decrease the stimulation intensity. Remote control 560 may also present various visual and audio indications for the user regarding the status of headset 100.
Headset 100 may be configured to wirelessly communicate with a mobile phone 570. The mobile phone interface may be used to present various data sent wirelessly by headset 100, for example, visual and audio indications regarding the status of headset 100 and usage logs.
Headset 100 may be configured to wirelessly communicate with laptop/PC 580. The mobile phone interface may be used to present various data sent wirelessly by headset 100, such as visual and audio indications regarding the status of headset 100 and usage logs.
Communication between headset 100 and remote control 560, mobile phone 570 and laptop 580 may be performed in various ways, known to those of ordinary skill in the art, for example by Bluetooth communication.
Reference is now made to
As seen in
It is appreciated that side electrodes 391 are constructed and operative similar to electrodes 130 and 140 described hereinabove with respect to
Additionally, as seen with particular clarity in
Turning specifically to
As seen in
Turning to
In some embodiments, proximal side electrodes 391a may be positioned to stimulate the zygomaticotemporal nerve indicated by reference numeral 396, and distal side electrodes 391b may be positioned to stimulate the auriculotemporal nerve, indicated by reference numeral 397. In some embodiments, such as when conducting transcranial stimulation, at least one of side electrodes 391 may be activated simultaneously with at least one anterior electrode 130 or 393a and 393b, with at least one contralateral side electrode 391, or with at least one posterior electrode 140 or 392a and 392b, thereby to stimulate regions of the frontal, temporal, and/or occipital lobes of the user's brain.
Turning to
As is known in the art, major challenge in stimulation of nerves in the head region is reaching sufficient nerve excitation without causing sensory discomfort or pain. The supraorbital and supratrochlear nerve branches (trigeminal nerve-ophthalmic division) are located superficially at the supraorbital region in close proximity to the periosteum of the skull bone which is densely innervated by nociceptive nerve fibers. Due to this unique anatomical proximity, attempts to conventionally stimulate the supraorbital and supratrochlear nerve branches typically result in concurrent excitation of the periosteum's nociceptive nerves which elicit a pain sensation. The inventors discovered that it is possible to effectively stimulate the supraorbital and supratrochlear nerve branches without causing pain by confining the stimulating electrodes to be located over a very specific anatomical region and by using an array of two pairs of electrodes. The electrodes in each pair are adapted to be in contact with the user's forehead above the target nerves while their lower edge is placed in close proximity to the user's eyebrows, the electrodes having a small distance between them. The current is confined to flow between the two electrodes of each pair, such that one pair is adapted to stimulate the left supratrochlear and supraorbital nerves and the second pair is adapted to stimulate the right supratrochlear and supraorbital nerve branches. The inventors discovered that this specific electrode arrangement and configuration facilitates effective isolated excitation of the target nerves while preventing deeper penetration of the electrical current to the pain conducting nerves located in the periosteum of the skull bone as well as to other areas of the forehead which were found to elicit painful sensation.
The inventors have further discovered that a similar electrode arrangement and configuration in the occipital region of the user's head facilitates effective isolated excitation of the target nerves while preventing stimulation of nociceptive nerve fibers in the periosteum.
Reference is now made to
As seen, an electronic circuit, such as electronic circuit 142 described hereinabove with reference to
According to features of the teachings herein, electronic circuit 142 may be suited for applying transcranial electrical stimulation using suitable methods such as Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), and Transcranial Random Noise Stimulation (tRNS).
As mentioned hereinabove, the electronic circuit 142 may be electrically associated with, and powered by rechargeable battery 144 that is electrically connected to internal power supply 506. In some embodiments, the internal power supply 506 provides power to high voltage circuit 502, which in turn is electrically connected to stimulation circuit 504. The charging circuit 514 is electrically associated with rechargeable battery 144, and may interface with an external power supply, such as a charger 518. The high voltage circuit 502 provides to stimulation circuit 504 current with voltage in the range of 1 V to 150 V.
In some embodiments, the stimulation circuit 504 receives information and/or commands from the microcontroller 500. The stimulation circuit 504 is configured to provide electrical stimulation pulses to the user's nerve tissues via one or more stimulation electrodes 520 disposed on the headset, such as stimulation electrodes 130 and/or 140 of
In some embodiments, stimulation circuit 504 may be configured to produce biphasic, charged balanced electrical pulses, mono-phasic electrical pulses, and/or direct current stimulation.
In some embodiments, the stimulation circuit 504 may be configured to produce electrical stimulation within an intensity range of 0-60 mA, 0-40 mA, 0-20 mA, 0-18 mA, or 0-15 mA.
In some embodiments, the stimulation circuit 504 may be configured to produce stimulation pulses with a duration of 10-1000 μsec, 50-600 μsec, 100-500 μsec, 130-300 μsec, 230-300 μsec, or 130-200 μsec.
In some embodiments, the stimulation circuit 504 may be configured to produce stimulation pulses at a frequency of 1-20,000 Hz, 1-10,000 Hz, 1-500 Hz, 10-300 Hz, 10-250 Hz, 20-180 Hz, 30-180 Hz or 40-100 Hz.
In some embodiments, electronic circuit 142 may include two or more high voltage circuits (not shown) similar to circuit 502, each high voltage circuit providing current at a voltage in the range of 1-150V, 1-120V, or 1-100V, to at least two of stimulation electrodes 520. In some embodiments, electronic circuit 142 may include at least two isolated output channels (not shown), for example galvanic isolated output channels, each output channel providing output to at least two of stimulation electrodes 520.
In some embodiments, the electronic circuit 142 also includes a feedback & measurements circuit 524, which collects voltage or current level information from the stimulation electrodes 520, and provides the collected information to the microcontroller 500. The microcontroller 500 uses the provided feedback to monitor and control the voltage and current levels in stimulation electrodes 520, for example via stimulation circuit 504, in order to maintain the desired stimulation level, to optimize energy consumption, and to ensure the user's safety. In some embodiments, monitoring and control of the voltage and current levels in stimulation electrodes 520 is in accordance with the method described herein with respect to
In some embodiments, the microcontroller 500 may instruct the stimulation circuit 504 to output electrical current in various patterns and/or for various periods of time, and/or may instruct the stimulation circuit 504 with regards to various stimulation parameters, such as the current amplitude, pulse frequency, phase duration, and amplitude of the current output by the stimulation circuit, as described hereinbelow with reference to
For example, the microcontroller 500 may instruct the stimulation circuit 502 to provide electrical current having an amplitude that ramps up, ramps down, or remains stable.
In some embodiments, the microcontroller instructs the stimulation circuit 504 to provide an output having a constantly changing pattern of at least one of the stimulation parameters.
In some embodiments, the microcontroller 500 may instruct the stimulation circuit 504 to provide an output signal having a different pattern for each of a plurality of activated pairs of electrodes. For example, the stimulation circuit 504 may stimulate one pair of electrodes at a pulse frequency of 50 Hz and a phase duration of 300 μsec and another pair of electrodes at a pulse frequency of 100 Hz and a phase duration of 200 μsec. In some embodiments, at any given time the microcontroller 500 may activate only one pair of electrodes, may activate a combination of electrodes, may activate several electrodes simultaneously, sequentially, or alternately.
In some embodiments, some electrodes 520 may provide as output an alternating current signal, whereas other electrodes 520 may provide as output a direct current. In some embodiments, at least two electrodes 520 may alternate the type of current provided as output between alternating current and direct current.
In some embodiments, during direct current stimulation in which excitation of a certain region of the brain is determined based on the polarity of an electrode which is positioned above that region of the brain, at least one electrode 520 may be assigned by the microcontroller 500 to be the anode, or positively charged electrode, and at least one other electrode 520 may be assigned to be the cathode, or negative charged electrode.
In some embodiments, stimulation patterns determined by or assigned by the microcontroller 500, for example as described above and hereinbelow with respect to
In some embodiments, the stored stimulation patterns may be modified by the user, for example using user interface 150 included in the headset, or using an external user interface. In some embodiments, a clinician may modify the stored stimulation pattern for a patient physically when the patient visits the clinician, or remotely, such as via a remote cloud base portal which is in communication with the patient's external interface.
In some embodiments, the stored stimulation patterns may be used to create a personalized neurostimulation protocol for the user, as described hereinbelow with reference to
In some embodiments, electronic circuit 142 may be configured to receive analog signal input, such as electroencephalogram (EEG) signals, skin conductance response (SCR) signals, impedance plethysmograph (IPG) signals, electromyograph (EMG) signals, or other bio-signals, from one or more sensors, such as sensing electrodes 526. In some embodiments, the bio-signals may be indicative of the impedance of the tissue receiving the neurostimulation signal, the charge provided to the tissue, and the like.
The analog signal input received from sensing electrodes 526 may be processed by analog signal processing circuit 510, and may be transferred therefrom to microcontroller 500. In some embodiments, electronic circuit 142 may be configured to receive digital, analog, or other input from additional sensors disposed on or within the headset, or located elsewhere in the vicinity of the user, and adapted to sense the vicinity of the user or characteristics thereof.
In some embodiments, one or more stimulation parameters may be altered by the microcontroller 500 due to inputs received from one or more of the additional sensors. For example, upon receiving certain EEG input from the analog signal processing circuit 510, the microcontroller 500 may modify one or more parameters of the stimulation current which is provided by the stimulation circuit 504, such as current amplitude, pulse frequency, and the like. In some embodiments, upon receiving input from the analog signal processing circuit 510, the microcontroller 500 may activate a specific combination and/or sequence of electrodes and/or may modify the duration of stimulation provided by certain electrodes.
In some embodiments, accelerometer 536, or any other suitable orientation sensor, may be configured to sense the angular position of the headset and thereby to provide an indication for proper placement of the headset on the user's head. Sensing of the angular orientation of the headset may enable microcontroller 500 to identify a change in the user's and/or system's conditions and to adjust or adapt the pulse provided by stimulating electrodes 520.
For example, in case that the user positions the headset upside down on his head, the accelerometer 536 may transfer headset orientation data sensed thereby to microcontroller 500, which may detect the misplacement of the headset and may prevent activation of the electrodes as long as the undesired position of the headset maintained. The user may be alerted to the misplacement of the headset, for example by user interface 150 or by a remote interface, and may be instructed to correct the headset position.
As another example, a change in the position of the user may result in a change in the pressure applied to the electrodes, thus changing how close the electrodes are to the user's skin and consequently changing the impedance in the system and requiring adaptation of the pulse applied to the tissue via the electrodes, as described hereinbelow.
In some embodiments, temperature sensor 538 may be configured to sense a temperature in the vicinity of the user or of the stimulating electrodes 520, and thereby may enable microcontroller 500 to identify a change in the user's and/or system's conditions and to adjust or adapt the pulse provided by stimulating electrodes 520. For example, an increase in the temperature in the vicinity of the user or of the electrodes 520 may result in more rapid dehydration of the electrodes or of conducting material applied thereto, thus increasing the impedance in the system and requiring adaptation of the pulse applied to the tissue via the electrodes, as described hereinbelow.
In some embodiments, pressure sensor 540 may be configured to sense pressure applied to the user's head in the vicinity of electrodes 520 or pressure applied directly to electrodes 520, and thereby may enable microcontroller 500 to identify a change in the user's and/or system's conditions and to adjust or adapt the pulse provided by stimulating electrodes 520. For example, an increase in the amount of pressure applied to electrodes 520 pushing them towards the user's scalp is expected to reduce the distance between the electrodes and the scalp, and in some cases the distance between the electrode and the target nerve, thereby reducing the impedance in the system and requiring, or allowing, adaptation of the pulse applied to the tissue via the electrodes, as described hereinbelow.
In some embodiments, humidity sensor 542 may be configured to sense a humidity or moisture level in the vicinity of the headset, the user, or the stimulating electrodes 520, and thereby may enable microcontroller 500 to identify a change in the user's and/or system's conditions and to adjust or adapt the pulse provided by stimulating electrodes 520. For example, a decrease in the sensed humidity in the vicinity of the electrodes 520 may be indicative of dehydration of the electrodes or of conducting material applied thereto, thus increasing the impedance in the system and requiring adaptation of the pulse applied to the tissue via the electrodes, as described hereinbelow.
In some embodiments, input received from the additional sensors and/or from sensing electrodes 526 may be transferred directly to the patient's clinician or care giver, for example via and external interface and a cloud based portal, allowing the clinician or care giver to monitor the patient's condition, and to alter the patient's treatment program and stimulation pattern accordingly.
In some embodiments, RF transceiver 508 may enable the microcontroller 500 to communicate with an interface of an external device 528, such as a mobile phone, a tablet, or a computer by way of radio frequency. The RF transceiver 508 may transmit digital information to and may receive digital information from the microcontroller 500, for example for personalization of the neurostimulation provided by the headset, as described hereinbelow with reference to
The interface of device 528 may comprise a software application that may be downloadable from a readily accessible resource, such as from the Internet. The interface may provide to a user thereof an indication, for example by way of a display, of the status of the headset, including, for example, information relating to active stimulation channels, stimulation intensity, active program, treatment time, headset battery status, and RF communication status, as well as various alerts such as alerts relating to electrode contact quality and to proper or improper headset alignment on the head. Additionally, the interface may provide to the user, for example by way of a display, usage logs and/or reports, such as information relating to daily stimulation time, stimulation parameters which were used during stimulation, and treatment programs which were used. The interface may also display, or otherwise provide, to the user raw or processed information received from sensors included in or associated with the headset.
In some embodiments, the headset may be controlled remotely via the interface of external device 528. For example, the external interface may enable a user thereof to activate or turn off the headset, start or pause stimulation, adjust the stimulation intensity for one or more channels, and select a treatment program. In some embodiments, information collected by the microprocessor 500 may be transmitted, via the external interface, to a remote location, such as a cloud based portal, where the information may be stored or may be analyzed and/or monitored, for example by a clinician or care taker, or as described hereinbelow with respect to
In some embodiments, user interface 150 may be configured to receive from the user an indication of the sensation the user is feeling, such as an indication of pain, an indication of discomfort, or an indication of decreased, or no, paresthesia. Such an indication from the user of a change in the sensation the user feels may enable microcontroller 500 to adjust or adapt the pulse provided by stimulating electrodes 520.
In some embodiments, user interface 150 located on the headset and the external user interface may enable parallel control of the headset, allowing the user to operate the headset by either of the interfaces. In some embodiments, the external interface serves as a display only and does not provide active control of the headset. In some embodiments, user interface 150 on the headset is obviated, and all interaction with the headset is carried out via the external interface. In some embodiments, the external interface comprises a proprietary electronic device. In some embodiments, the external interface may communicate with electronic circuit 142 via a cable, such as a USB cable.
Reference is now made to
As seen in
The sensors 602 may include any suitable type of sensor, such as temperature sensors, orientation sensors, blood pressure sensors, pulse oximetry sensors, electrical conductivity sensors such as sensors for measuring skin conductance response (SCR) and impedance plethysmograph (IPG), electroencephalogram (EEG) and electromyograph (EMG).
The user dons headset 600 in a similar manner to that described hereinabove with reference to
Reference is now made to
Initially, at step 700, the microcontroller 500 instructs the stimulation circuit 504 to provide, via the stimulation electrodes 520 that engage the user's scalp surface, one or more electrically balanced singular pulses, each having a single positive phase and a single negative phase. An example of such a pulse, provided under standard impedance conditions, is illustrated in
The microcontroller 500 continuously, periodically or intermittently evaluates whether the voltage required by the electrodes to provide the pulse has reached a predetermined threshold value, or upper voltage threshold, at step 702. The threshold value may be equal to the compliance voltage of the circuit 142, or may be a fraction or percentage thereof. In some embodiments, the threshold value is 60%-70% of the compliance voltage.
In some embodiments, following evaluation of the voltage required by the electrodes to provide the pulse, or concurrently therewith, the microcontroller 500 evaluates whether the impedance in the system has reached a predetermined impedance threshold value, at step 704. This would be suitable when predetermined impedance is reached even if voltage threshold is not reached, for example if the pulse is provided at a relatively low current. In some embodiments, the impedance threshold may be greater than 8KΩ, greater than 10KΩ or greater than 12KΩ.
If the voltage has not reached the voltage threshold, and the impedance has not reached the impedance threshold, the microcontroller 500 instructs the stimulation circuit 504 to continue providing, via the stimulation electrodes 520, a balanced singular pulses at step 700.
It will be appreciated that when the voltage in the system is insufficient for providing the pulse, or if the impedance in the system is too high, then according to Ohm's law the current provided by the electrodes will be insufficient to allow for the full charge to be provided to the tissue.
As such, if the evaluation at step 702 determines that the voltage has reached the voltage threshold, and/or if the evaluation at step 704 determines that the impedance has reached the impedance threshold, the pulse provided by the electrodes 520 will be cut. Consequently, at step 706 the microcontroller 500 instructs the stimulation circuit 504 to change the pulse provided via electrodes 520 to be a phase train pulse, similar to the pulse shown in
The inventors have found that the transition from the singular pulse of
It is a particular feature of the teachings herein that a time ratio trp between a cumulative duration drtp of the rest times 856 between the positive phases 854 and a cumulative duration dsp of the positive phases 854 is smaller than a predetermined ratio. Similarly, a time ratio trn between a cumulative duration drtn of the rest times 862 between the negative phases 860 and a cumulative duration dsn of the negative phases 860 is smaller than a predetermined threshold ratio. In some embodiments, the predetermined threshold ratio is in the range of 0.4-1.2, 0.5-1 or 0.55-0.75. In some embodiments, the predetermined threshold ratio is 0.6, as explained hereinbelow in Example 1.
In some embodiments, such as the embodiment of
In some embodiments, the rest times 856 between immediate successor positive phases 854 and the rest times 862 between immediate successor negative phases 860 have a common rest-time value rt1. In other embodiments, the rest times 856 between immediate successor positive phases 854 have a common rest time value rtp, which may be different from a common rest time value rtn of the rest times 862 between immediate successor negative phases 860. In yet further embodiments, the rest times 856 need not have a common rest time value, and the rest times 862 need not have a common rest time value. It will be appreciated that for the purposes of this specification and the claims that follow the term “common rest time value” relates to an equal rest time values, but also includes rest time values with at most 20%, at most 15%, at most 10%, at most 5%, or at most 1% deviation from one another.
In some embodiments, a duration of the positive phase train 850 is equal to a duration of the negative phase train 858, though it need not necessarily be equal. In some embodiments, the cumulative duration dsp of the positive phases 854 is equal to the cumulative duration dsn of the negative phases 860, though it need not necessarily be equal. In some embodiments, the cumulative duration drtp of the rest times 856 between the positive phases 854 is equal to the cumulative duration drtn of the rest times 862 between negative phases 860, though it need not necessarily be equal.
The number of positive phases 854 in positive phase train 852, and the number of negative phases 860 in negative phase train 858, is in the range of 2-30. In some embodiments, the number of positive phases 854 in positive phase train 852 is equal to the number of negative phases 860 in negative phase train 858, though it need not necessarily be equal.
In some embodiments, the duration of each rest time 856 or 862 is at least 5 μsec. In some embodiments, the phase width of each positive phase 854 and of each negative phase 860 is at most 600 μsec, at most 400 μsec, at most 300 μsec, at most 200 μsec, at most 100 μsec, or at most 50 μsec.
Returning to
In some embodiments, the charge provided by the phases is monitored by sensing electrodes 526, which, in some embodiments, may be the same electrodes as stimulating electrodes 520. In some embodiments, the charge is monitored by an additional sensor, external to the stimulating electrodes 520 and sensing electrodes 526, which is functionally associated with circuit 142, such as for example a sensor in sensor array 516.
In some embodiments, the charge is monitored by monitoring a waveform of each provided phase, to identify whether the provided waveform for the phase is identical to an intended waveform, or deviates from the intended waveform by at most 15%, at most 10%, at most 5%, at most 3%, or at most 1%. In some embodiments, a reduction in the charge provided to the scalp, or insufficient charge, is indicated by the provided waveform differing from the intended waveform more than the permissible deviation, and specifically by the provided waveform dropping, or being “cut”, toward the end of a phase. Referring additionally to
If at step 708 it is determined that insufficient charge is being provided, for example by determining that the waveform of the pulse is similar to that shown in
If at step 710 the microcontroller 500 determines that the maximal allowed rest time has not been reached, at step 712 the microcontroller 500 instructs the stimulation circuit 504 to update at least one rest time in the provided pulse. Due to the fact that the maximal allowed rest time has not been reached, the microcontroller updates the pulse by increasing at least one rest time in the positive phase train and/or in the negative phase train.
In some embodiments, the microcontroller 500 instructs the stimulation circuit 504 to update the pulse by increasing all the rest times in the positive phase train, and/or all the rest times in the negative phase train. In some embodiments, the microcontroller 500 instructs the stimulation circuit 504 to increase the common rest time value rW in the positive phase train, the common rest time value rtn in the negative phase train, or the common rest time value rt1 in the pulse.
If the maximal allowed rest time has been reached at step 710, at step 714 the microcontroller 500 evaluates whether the voltage provided by the electrodes has reached a predetermined voltage threshold, such as the compliance voltage of the system or a predetermined fraction or percentage thereof.
If at step 714 the microcontroller 500 determines that the voltage threshold has been reached, that means that the rest times cannot be increased (due to the determination at step 710), and the voltage cannot be increased (due to the determination at step 714). As such, it is likely that there is a bad electrical contact between the electrodes 520 and the user's scalp, or another malfunction in the system, and at step 716 the microcontroller 500 may provide to the user an indication of such a malfunction or bad electrical contact, for example via user interface 150. Subsequently, treatment is aborted.
Alternately, if at step 714 the microcontroller 500 determines that the voltage threshold has not been reached, at step 718 the microcontroller 500 instructs the stimulation circuit 504 to increase the voltage to be applied by electrodes 520, and subsequently updates at least one rest time in the provided pulse at step 712. In some embodiments, due to the fact that the maximal allowed rest time has been reached, the microcontroller 500 instructs the stimulation circuit 504 to update the pulse by reducing at least one of the rest times in the positive phase train and/or in the negative phase train.
In some embodiments, the microcontroller 500 instructs the stimulation circuit 504 to update the pulse by reducing all the rest times in the positive phase train, and/or all the rest times in the negative phase train. In some embodiments, the microcontroller 500 instructs the stimulation circuit 504 to reduce the common rest time value rtp in the positive phase train, the common rest time value rtn in the negative phase train, or the common rest time value rt1 in the pulse.
In some embodiments, following the increase in voltage at step 718, and the reduction in the rest time at step 712, the phase train pulse has the waveform shown in
In some embodiments, any rest time reduced by the microcontroller 500 or by stimulation circuit 504 is reduced to a minimal rest time, which, in some embodiments, is not less than 5 μsec.
It will be appreciated that in some embodiments, the change to the rest times is carried out by microcontroller 500 instructing the stimulation circuit 504 to change one or both of the time ratio trP, between a cumulative duration drtp of the rest times 756 between the positive phases 754 and a cumulative duration dsp of the positive phases 754, and the time ratio trn, between a cumulative duration drtn of the rest times 862 between the negative phases 860 and a cumulative duration dsn of the negative phases 860.
In some embodiments, at step 712 the microcontroller 500 may instruct the stimulation circuit 504 to adapt additional characteristics of the pulse. In some embodiments, at step 712 the microcontroller 500 may also instruct the stimulation circuit 504 to adapt the number of positive phases in the positive phase train and/or the number of negative phases in the negative phase train. In some embodiments, at step 712 the microcontroller 500 may also instruct the stimulation circuit 504 to adapt the phase width of one or more of the positive phases, or a common phase width wp of the positive phases. In some embodiments, at step 712 the microcontroller 500 may also instruct the stimulation circuit 504 to adapt the phase width of one or more of the negative phases, or a common phase width wn of the negative phases. In some embodiments, the microcontroller 500 may also instruct the stimulation circuit 504 to adapt the amplitude of one or more of the positive phases and/or of one or more of the negative phases.
Following the change to the rest times applied by the microcontroller 500 at step 712, the microcontroller 500 continues to evaluate whether or not sufficient charge is provided by each phase of the pulse at step 708, and additional updates to the rest-time and/or voltage may be applied.
At any occurrence of step 708, if the microcontroller 500 determines that sufficient charge is being provided by each phase of the pulse to the scalp of the user, at step 720 the microcontroller 500 instructs the stimulation circuit 504 to continue to provide the pulse as established.
The microcontroller 500 then waits for an indication that additional monitoring is required, at step 722. When such an indication is provided, the microcontroller returns to step 708 and assesses whether the pulse is providing sufficient charge, and flow continues from there as described hereinabove. Otherwise, the microcontroller continues to provide the established pulse.
In some embodiments, the indication is a microcontroller-internal indication, for example a time indication for periodic monitoring, for example provided every 10 minutes, every 5 minutes, or every 3 minutes. In some such embodiments, additional monitoring may be carried out more frequently at the initial part of the treatment, and then carried out less frequently at later stages of the treatment once the system has reached an equilibrium.
In other embodiments, the indication may be received from a component external to the microcontroller. For example, the indication may be an indication of discomfort, pain, or reduced paresthesia, provided by the user, via user interface 150.
In some embodiments, the indication may be provided by a sensor sensing a change in the system. For example, microcontroller 150 may receive from a humidity sensor forming part of sensor array 516 a signal indicating a change in the humidity in the vicinity of electrodes 520, which requires additional monitoring. As another example, microcontroller 500 may receive from a temperature sensor forming part of sensor array 516 a signal indicating a change in the temperature in the vicinity of electrodes 520, which requires additional monitoring. As a further example, microcontroller 500 may receive from a pressure sensor forming part of sensor array 516 a signal indicating a change in the pressure applied to electrodes 520, which requires additional monitoring. As yet another example, the microcontroller 500 may receive from an accelerometer forming part of sensor array 516 a signal indicating a change in the position of the user or in the position of the electrodes, which may indicate that additional monitoring is required (for example, if the user was supine and is now standing, less pressure is applied to the electrodes, which may increase the impedance).
It will be appreciated that in order to evaluate the quality of signal transduction in the system (at step 708), one may replace the evaluation of the charge provided by the phases of the pulse with an evaluation of the impedance in the system, which, due to Ohm's law, is equivalent to the evaluation of the charge. In such embodiments, the rest times in the provided pulse and/or voltage of the provided pulse would be updated if the impedance measured between the electrodes 520 is above a predetermined impedance threshold. In some embodiments, the impedance threshold may be greater than 8KΩ, greater than 10KΩ or greater than 12KΩ.
Reference is now made to
As seen at step 750, initially, data for generating a treatment model for a specific user is obtained. In some embodiments, the data may be obtained from a remote database, either based in a server or Cloud based, as indicated by reference numeral 751. In some embodiments, the data may be based on specific information relating to the user, such as characteristics of the patient such as age, weight, and hair type, and values collected during previous treatments such as stimulation intensity, impedance levels reached, voltage levels reached, changes in voltage/impedance during treatment, and/or treatment duration.
Subsequently, at step 752, a treatment model is generated based on default values modified in accordance with the obtained data. In some embodiments, the treatment model takes into consideration currently collected treatment data, such as information relating to the current state of the system as identified by sensors in the system (e.g. sensors in sensor array 516), which information may include humidity information as identified by a humidity sensor, temperature information as identified by a temperature sensor, position information as identified by an accelerometer, and the like. Additionally, the system may allow the user to provide input, for example via user interface 150, relating to the current state of the system, and to use the input to generate the treatment model. For example, the user may indicate that skin irritation or excess skin erythema occurred, which can be used to update the treatment model for this specific user.
At step 754, the microcontroller of the system generates a prediction of the voltage and/or pulse form that will be required in order to provide sufficient charge to the specific user's scalp, while using a reasonable voltage and short rest times between phases. At step 756, the prediction is used to initiate treatment in accordance with the method of
At step 758, during and/or after treatment, the actual voltage required in order to provide sufficient charge to the user's scalp and/or parameters of the actual waveform used to provide such charge (for example the number of positive and negative phases, the length of each positive and negative phase, the lengths of the rest times between phases, and the like) are recorded by the microcontroller, and stored in a memory associated therewith.
In some embodiments, the recorded data may be transmitted to a remote database, either located at a remote server or Cloud based, as seen at step 760. The data may be stored in the remote database, in some embodiments associated with at least one identifier of the specific user, such as an identification number or name of the user, or with at least one identifier of the device used by the user, so that it may be readily used in the next treatment session, for example as the data obtained at step 750.
Reference is now made to the following example, which together with the above description, illustrates the invention in a non-limiting fashion.
Ten users were treated using the system of
The treatment included stimulation of the greater occipital nerve. A headset, similar to that shown in
Stimulation in the form of electrically balanced pulses was applied at a constant current of 5 mA and at a frequency of 80 Hz.
In a baseline round, the provided positive and negative phases were singular phases each having a phase duration of 400 μsec, as described hereinabove with reference to
In each subsequent round of treatment, the pulse included a positive phase train and a negative phase train as described hereinabove with reference to
The results are summarized in
The table 870 includes a title row 872, a first baseline row 874, and a plurality of treatment rows 876, each relating to a single round of treatment. Each of the rows is divided into a plurality of columns 878, including:
A closer look at table 870 shows that as the cumulative rest time increases, the voltage required in order to provide sufficient charge to the scalp of the user decreases, as well as the paresthesia experienced by the user. Looking specifically at the lowest row 876h of the table 870, it is seen that the voltage required to provide the pulse, when the cumulative rest time is double the length of the cumulative phase duration, has decreased by as much as 67%, and the paresthesia experienced by the user has decreased entirely, to the point that the users only felt negligible paresthesia, if any.
As seen in
As seen, at the point of the plateau having the greatest rest time percentage, indicated in
Turning to
It will be appreciated that in accordance with the illustrated results, the identified rest time percentage of 60% is particularly suitable as the rest time threshold as it significantly reduces the voltage required in order to provide sufficient charge to the user's scalp, while the user continues to feel significant levels of paresthesia in the nerve distribution region, which is desirable.
As used herein in the specification and in the claims section that follows, the term “or” is considered as inclusive, and therefore the phrase “A or B” means any of the groups “A”, “B”, and “A and B”.
As used herein in the specification and in the claims section that follows, the term “circumferential” means forming a closed shape encompassing 360 degrees of a circle.
As used herein in the specification and in the claims section that follows, the term “operational mode”, or the like, with respect to a headset or headset component, refers to a headset or headset component that is fitted onto the head of the user, in a suitable rotational and longitudinal disposition, with electrical stimulation being applied.
As used herein in the specification and in the claims section that follows, the term “donned mode”, “donned”, or the like, with respect to a headset or headset component, refers to a headset or headset component that is fitted onto the head of the user, in a suitable rotational and longitudinal disposition, with electrical stimulation being applied.
As used herein in the specification and in the claims section that follows, the term “integral” refers to a structure behaving as a single, whole structure. The term may be applied in particular to flexible structures such as an electrode pad.
As used herein in the specification and in the claims section that follows, the term “pulse” relates to an electrical signal, for example applied via an electrode or sensed by an electrode.
As used herein in the specification and in the claims section that follows, the term “phase” relates to a pulse or a portion thereof, having current starting from a zero amplitude, changing to a higher amplitude, and returning to zero amplitude.
As used herein in the specification and in the claims section that follows, the term “positive phase” relates to a phase providing current which flows in the positive direction.
As used herein in the specification and in the claims section that follows, the term “negative phase” relates to a phase providing current which flows in the negative direction.
As used herein in the specification and in the claims section that follows, the term “balanced pulse” relates to a pulse including a positive portion including at least one positive phase and a negative portion including at least one negative phase, such that the magnitude, or charge, of the positive and negative portions is equal, or is within 15%, within 10%, within 5%, within 3%, or within 1% of one another.
As used herein, in the specification and in the claims section that follows, the term “phase train” relates to a pulse including two or more consecutive phases of the same type or magnitude, or in the same direction. For example, a positive phase train includes two or more consecutive positive phases and a negative phase train includes two or more consecutive negative phases. Any phases in the opposite direction, having a charge of up to 30% of the charge of the lowest-charge phase in the phase train, are considered as noise and are disregarded when defining a phase train and identifying consecutive phases. For example, a pulse including two positive phases, then a very small short negative phase, and then additional phases, would be considered a positive phase train, because the small short negative phase is disregarded.
As used herein, in the specification and in the claims section that follows, the term “phase train pulse” relates to a pulse including at least one positive phase train and at least one negative phase train.
As used herein, in the specification and in the claims section that follows, the term “balanced phase train pulse” relates to a balanced pulse including at least one positive phase train and at least one negative phase train.
As used herein, in the specification and in the claims section that follows, the term “singular pulse” relates to a pulse including a single positive phase and/or a single negative phase, and not including a phase train.
It will be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. Similarly, the content of a claim depending from one or more particular claims may generally depend from the other, unspecified claims, or be combined with the content thereof, absent any specific, manifest incompatibility therebetween.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1601536.4 | Jan 2016 | GB | national |
The present application is a continuation in part of U.S. patent application Ser. No. 17/242,962, filed on Apr. 28, 2021. U.S. patent application Ser. No. 17/242,962 is a continuation of U.S. patent application Ser. No. 16/070,563, filed on Jul. 16, 2018. U.S. patent application Ser. No. 16/070,563 is a National Stage Entry of PCT Patent Application No. PCT/IB2017/050416, filed on Jan. 25, 2017. PCT Patent Application No. PCT/IB2017/050416 gains priority from GB Patent Application No. 1601536.4, filed on Jan. 27, 2016. The present application is also a continuation in part of U.S. patent application Ser. No. 17/469,640 filed on Sep. 8, 2021. U.S. patent application Ser. No. 17/469,640 is a continuation of U.S. patent application Ser. No. 16/093,094, filed on Oct. 10, 2018. U.S. patent application Ser. No. 16/093,094 is a National Stage Entry of PCT Patent Application No. PCT/IB2017/052045, filed on Apr. 8, 2017. PCT Patent Application No. PCT/IB2017/052045, gains priority from U.S. Provisional Patent Application No. 62/322,498, filed on Apr. 13, 2016. U.S. patent application Ser. Nos. 17/242,962; 16/070,563; 17/469,640; and Ser. No. 16/093,094; PCT Patent Application Nos. PCT/IB2017/050416 and PCT/IB2017/052045; GB Patent Application No. 1601536.4; and U.S. Provisional Patent Application No. 62/322,498 are all incorporated by reference as if fully set forth herein.
| Number | Date | Country | |
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| 62322498 | Apr 2016 | US |
| Number | Date | Country | |
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| Parent | 16070563 | Jul 2018 | US |
| Child | 17242962 | US | |
| Parent | 16093094 | Oct 2018 | US |
| Child | 17469640 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17242962 | Apr 2021 | US |
| Child | 18388866 | US | |
| Parent | 17469640 | Sep 2021 | US |
| Child | 18388866 | US |
