WO2017125921A2

WO2017125921A2 - Device system and method for noninvasive application of stimuli

Info

Publication number: WO2017125921A2
Application number: PCT/IL2017/050064
Authority: WO
Inventors: Herzel KAMERY; Yaron RIVER; Eliran AMAR
Original assignee: L.E.V. Lakeev Ltd.
Priority date: 2016-01-18
Filing date: 2017-01-18
Publication date: 2017-07-27
Also published as: WO2017125921A3

Abstract

A noninvasive device for application of stimuli over one or more body areas of an patient, the device having one or more tactile stimulators for application of vibrations tactile stimulation; one or more optical stimulators; electrode stimulators; a base structure configured for being attached to or placed over the at least one body area of the patient and for holding the stimulators of the device; and a controller for controlling operation of the stimulators of the device The stimulators of the device are located over the base structure according to the body area being stimulated and anatomic locations of the muscle and nerve tissues of the particular body area being stimulated such that each optical stimulator is located to direct optical signals therefrom to nerve tissue of the body area and each tactile stimulator is located to vibrate muscle tissue of the body area.

Description

DEVICE SYSTEM AND METHOD FOR NONINVASIVE

APPLICATION OF STIMULI

FIELD OF THE INVENTION

[0001] The present invention generally relates to devices, apparatuses, systems and methods for therapeutic treatments and more particularly to systems methods and devices that use non-intrusive stimuli for therapeutic treatment.

BACKGROUND OF THE INVENTION

[0002] Chronic pain constitutes a significant challenge to modern medicine. Single modality treatment of chronic pain often fails due to the redundancy and diversity of the neural systems involved in nociception, signal pain transduction in the peripheral nervous system and pain processing in the central nervous system. The challenge is even greater for neuropathic pain due to nerve entrapment, phantom pain, and stump pain. Some solutions involve one or more stimuli devices for noninvasive pain alleviation treatment, using stimulations such as heating the painful area, tactile stimuli and/or inducing electric current using electrodes.

[0003] Low Light Laser Therapy (LLLT) is a known method for treatment and alleviation of inflammatory and chronic pain. This method is based on the stimulation of inflicted body tissues with low power laser radiation in specific wavelengths, resulting in inter alia, tissue heating, augmented blood supply, modulation of inflammatory processes, increased cell metabolism, increased oxidative processes, changes in nerve action potentials, and new formation of capillaries.

[0004] Transcutaneous neural stimulation (TENS) has been known as a method for the treatment of neuropathic pain for over three decades (see

Hansson, 1999).

[0005] Vibration as a therapeutic tool is thought to activate Pacinian skin corpuscles and fast Αβ fibers and thus decrease the activation of secondary neurons, in the dorsal horn of the spinal cord, relaying nociceptive information to higher brain centers. In addition this stimulation increases/decreases central nervous system signal to noise ratio. Vibro tactile stimulation has been shown to reduce chronic local or widespread musculoskeletal pain

[0006] Patent application publication no. US2013085420(A1) teaches a non- invasive apparatus for rehabilitating a joint, limb, and muscles of a patient recovering from surgery on the joint, which includes a continuous passive motion device having at least one support member for supporting the limb, at least one hinge coupled to the at least one support member, and at least one actuator for providing reciprocating motion of the at least one support member about the at least one hinge, a plurality of electrodes transmitting at least four modalities chosen from a group consisting of functional electrical stimulation (FES), transcutaneous electrical nerve stimulation (TENS), temperature therapy stimulation, deep vein thrombosis (DVT) prophylactic stimulation, venous blood flow monitoring, and pain monitoring, and a control unit controlling the at least one actuator and the plurality of electrodes according to a coordinated sequence of the reciprocating motion and transmission of the at least four modalities... While the device is in operation, the electrodes provide a plurality of modalities to the joint and limb to maximize the effectiveness of the therapeutic treatment. The modalities include functional electrical stimulation (FES), Transcutaneous electrical nerve stimulation (TENS), temperature therapy, DVT prophylactic therapy, venous blood flow monitoring, and pain monitoring. In one

embodiment, the control unit includes a neuromuscular feedback component electrically connected to the microcontroller and electrodes via second conductors. The neuromuscular feedback component functions to observe and record a response in a muscle mass upon the transmission of a FES modality. Using the recorded muscle response and information on the coordinated sequence, the neuromuscular feedback component adjusts the FES modality.

[0007] Patent application publication no. US205107831 teaches a system for the therapeutic application of energy to a patient in the form of electrical stimulation, ultrasound, radio frequency (or short wave) diathermy, eddy current heat and/or laser energy.

[0008] Patent application publication no. WO2013117655 (Al) teaches an apparatus for stimulating neurons having a pathological synchronous and oscillatory neural activity, said apparatus comprising a non-invasive stimulation unit for applying stimuli that stimulate a patient's neurons, a measurement unit for recording test signals that represent a neural activity of the stimulated neurons, and a control and analysis unit for controlling the stimulation unit and analyzing the test signals.

[0009] Other patent applications and patents such as US2013041296 (Al), US2013085317 (Al), and US2014207219 teach noninvasive appliance of various types of stimuli to a patient's body area such as heat electric current and others.

SUMMARY OF THE INVENTION

[0010] The present invention provides a noninvasive device for application of stimuli over one or more body areas of a patient, the device having one or more tactile stimulators, each adapted to produce vibrations for applying tactile stimulation; one or more optical stimulators for applying stimulation by outputting optical signals within at least one frequency range; electrode stimulators; a base structure configured for being attached to or placed over the at least one body area of the patient and for holding the stimulators of the device; and a controller for controlling operation of the stimulators of the device The stimulators of the device are located over the base structure according to the body area being stimulated and anatomic locations of the muscle and nerve tissues of the particular body area being stimulated such that each optical stimulator is located to direct optical signals therefrom to nerve tissue of the body area and each tactile stimulator is located to vibrate muscle tissue of the body area.

The present invention provides a noninvasive device for application of stimuli over one or more body areas of a treated patient, for the purpose of alleviating pain or providing therapeutic affect, said device incorporating at least one stimulator of the following types:

a) tactile stimulator, adapted to produce movement for applying tactile stimulation;

b) optical stimulator, for applying stimulation by outputting optical signals within at least one frequency range;

c) electric stimulator, applying stimulation by emitting electric current between at least two electrodes;

The device further incorporates:

· a base structure designed to attach to, or be placed over an at least one treated body area of a treated patient and for holding the stimulators of the device; and

• at least one controller for controlling the operation of each of the stimulators incorporated in the device,

wherein each optical stimulator is accurately located to direct optical signals therefrom to nerve tissue of the treated body area, and each pair of electrodes are oriented to apply electrical stimulus to nerve tissue of the treated body area, and each tactile stimulator is accurately located to apply tactile stimulation to muscle tissue of the treated body area.

According to some embodiments of the present invention the base structure is configured such as to allow adjustment of the stimulator types and the number of stimulators, according to the required treatment, the particular treated body area and the particular patient.

According to some embodiments of the present invention the said base structure is configured such as to allow adjustment of the stimulator locations and stimulator density, according to the required treatment, the particular treated body area and the particular patient, such that: a. each optical stimulator is accurately located to direct optical radiation therefrom to nerve tissue of the treated body area, b. each pair of electrodes is oriented to apply electric stimulus therefrom to nerve tissue of the treated body area, and c. each tactile stimulator is accurately located to apply tactile stimulation to muscle tissue of the treated body area.

According to some embodiments of the present invention the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol, said protocol determining at least one of the following parameters:

• power

• schedule

· frequency

• duty-cycle

per each of the different stimulator types; optical, tactile and electric stimulators. According to some embodiments of the present invention the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling simultaneous operation of at least some of the stimulators. According to some embodiments of the present invention the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling sequence scheduled operation of at least some of the stimulators. According to some embodiments of the present invention the at least one controller accumulates patient- specific feedback and treatment- specific data for analysis, either locally or on a cloud-based data server, such as to produce optimal treatment protocols for both individual patients and for groups of patients.

According to some embodiments of the present invention the at least one controller accumulates patient- specific data pertaining to the patient's

sensitivity and pain thresholds in relation to at least one of the following stimuli:

• lower threshold of sensitivity to electric stimulus

• lower threshold of sensitivity to tactile stimulus

• threshold for sensation of pain, induced by electric stimulus

wherein the said sensitivity and pain threshold data is stored and used for future follow up on the patient's condition.

According to some embodiments of the present invention said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein low skin impedance areas correlating with improved IR laser energy penetration are selected for applying said optical stimulation,

According to some embodiments of the present invention said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein skin impedance data is propagated to said

microcontroller, and is taken into account in electrical and optical stimulation signal setting.

According to some embodiments of the present invention the said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein , said microcontroller propagates the skin

impedance information to an online Sever, which: includes this data in the logging of specific treatment sessions, correlates it with additional treatment- specific data, and produces optimal treatment protocols for groups of users

According to some embodiments of the present invention the device is designed in cylindrical shape, which incorporates a series of stimulation patches , such that the distance between the stimulation patches is adjustable, to fit the patient organ size and the required treatment.

The present invention provides a method for alleviating pain or providing therapeutic affect by applying noninvasive stimuli using at least one controller, over one or more body areas of a treated patient, for the purpose of alleviating pain or any other therapeutic purpose, said stimuli

incorporating at least one of the following stimulus types:

• electrical,

· optical, and

• tactile,

wherein the said method involves the exact positioning of said optical, electrical and tactile stimuli, for attaining the maximal effectiveness of the treatment, wherein the positioning implement at least one of the following:

• applying the said optical stimulus to nerve or nerves of the treated body area that are involved in the pathogenesis of neuropathic pain

• applying the said electrical stimulus so as to maximize paresthesia in the sensory distribution of a nerve or nerves involved in the evolution of neuropathic pain, and

• applying the said tactile stimulus to muscle tissue of the treated body area, so as to maximize vibro-tactile stimulation of muscles involved in myofascial pain.

• power

• schedule

• frequency

• duty-cycle

per each of the different stimulator types; optical, tactile and electric stimulators.

According to some embodiments of the present invention the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling simultaneous operation of at least some of the stimulators.

According to some embodiments of the present invention the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling sequence scheduled operation of at least some of the stimulators.

According to some embodiments of the present invention the at least one controller accumulates patient- specific data pertaining to the patient's sensitivity and pain thresholds in relation to at least one of the following stimuli:

• lower threshold of sensitivity to electric stimulus

• lower threshold of sensitivity to tactile stimulus

• threshold for sensation of pain, induced by electric stimulus wherein the said sensitivity and pain threshold data is stored and used for future follow up on the patient's condition. According to some embodiments of the present invention the design of the stimulators patches is adjustable before treatment by applying the following steps:

- Identify the nerve or nerves that are involved in

the pathogenesis of the neuropathic pain;

- Locate the central laser emitting diodes

accordingly; and

- Orient the stimulation patches such as to maximize paresthesia in the sensory distribution of a nerve or nerves involved in the evolution of the neuropathic pain syndrome.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1A schematically illustrates a system for application of multiple stimulation types over a body area, using multiple TENS electrode stimulators, multiple laser stimulators and multiple vibration tactile stimulators, according to some embodiments of the present invention.

[0012] Figure IB shows an exemplary implementation of the system 100 for application of stimuli of multiple stimulation types over a body area, according to one embodiment of the present invention.

[0013] Figure 2 shows a noninvasive stimulation patch for application of stimuli over one or more body areas of a patient, according to some

embodiments of the invention.

[0014] Figures 3A and 3B show two stimulation patches placed over a stump of a patient for pain treatment and alleviation, according to some embodiments of the invention, for application of stimuli attached to the patient's stump.

[0015] Figure 4 shows a stimulation patch placed over a wrist of a patient for carpal tunnel syndrome treatment, according to some embodiments of the present invention. [0016] Figure 5 shows a bracelet contraption, which incorporates a series of stimulation patches, according to some embodiments of the present invention.

[0017] Figure 6 shows two stimulation patches placed over the back of a patient' s head for pain treatment, according to some embodiments of the present invention.

[0018] Figure 7 shows two stimulation patches placed over the forehead of a patient for headache alleviation and/or treatment, according to some

embodiments of the present invention.

[0019] Figure 8 shows two stimulation patches placed over the foot of a patient for treatment of neuropathic and /or ischemic pain, according to some embodiments of the present invention.

[0020] Figure 9 shows an exemplary graphic user interface (GUI) screenshot indicating the stimulators' states and optionally allowing a user to set the stimulators' properties such as intensities, frequency of stimulation (timing), pulse parameters and the like, according to some embodiments of the invention.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

[0021] In the following detailed description of various embodiments, reference is made to the accompanying drawings that form a part thereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

[0022] Following is a table of definitions of the terms used throughout this application.

body.

Optical A device designed to stimulate body tissues by directing stimulator Electromagnetic radiation to it. An example for such a device given in some embodiments of the present invention is an IR laser emittance diode.

Tactile A device designed to stimulate body tissues by applying stimulator mechanical movement, e.g. through vibration or kneading motion to the said tissue.

TENS Transcutaneous neural stimulation (TENS) is a method for the stimulator treatment of neuropathic pain by conducting weak electrical current through a patient's body.

A TENS stimulator is a hardware device designed to stimulate body tissues through conduction of such weak electrical current between at least two electrodes.

Stimulation A device consisting of, inter alia, an aggregation of one or patch more stimulators, all mounted or installed on a support member, and designed to be attached to a patient's body.

Sensory Pain threshold: minimal stimulus (e.g. optical, tactile or thresholds electrical stimulus) level that is considered by a patient as painful

Sensitivity threshold: the minimal stimulus (e.g. optical, tactile or electrical stimulus) that could be detected by the patient

[0023] The present invention provides noninvasive devices, systems and methods for application of stimuli over one or more body areas of a treated patient e.g. for pain alleviation and/or treatment or for any other therapeutic purpose. The devices, systems and methods of the present invention can be found useful for, yet are not limited to alleviation of acute types of pain, such as phantom pain, neuropathic pain, ischemic pain, migraines, carpal tunnel syndrome pain and more.

[0024] The stimulation patch disclosed in the present invention incorporates at least one of the following stimulator types: • One or more tactile stimulators, each adapted to produce vibrations for applying tactile stimulation to a patient's body.

• One or more optical stimulators such as Laser emitting diodes, corresponding to one or more wavelengths, each designed to apply laser radiation stimulation to a patient's body,

• Two or more electrodes, designed to apply electric current stimulation (e.g. TENS) to a patient's body.

[0025] The stimulation patch device combines the complementary pain- relieving properties of the said stimulator types. It optimizes the synergy between their different pain-relieving properties, optionally taking patient feedback into account and optionally producing optimized stimulus treatment methods based on accumulated statistical treatment data.

[0026] The stimulation patch disclosed in the present invention further incorporates a base structure configured for being attached to, or placed over at least one body area of the patient, and for holding the stimulators.

[0027] The stimulators are mounted over the base structure, and located according to the body area being stimulated and the anatomic location of muscle and nerve tissues of that particular body area. The said location is determined according to the following guidelines:

· Each optical stimulator is individually located to direct optical signals therefrom to nerve clusters within the stimulated body area.

• Each tactile stimulator is individually located to vibrate muscle tissues of the body area.

The said guidelines constitute an essential part of the present invention, as they are the key for successful application of the stimulation patch device.

[0028] According to one embodiment of the present invention, the

stimulation patch is designed in the form of a bracelet, and may thus be easily worn by the patient on their wrist. [0029] The stimulation patch disclosed in the present invention further incorporates a controller, for controlling the operation of all the incorporated stimulators.

[0030] The tactile stimulators may include vibrating members, capable of vibrating vertically in respect to the surface of the skin of the patient, thus applying vertical stimulation e.g. by having an element laterally moved in a vertical direction in a repeated manner upwardly and downwardly.

[0031] The location of each tactile stimulator mounted on the stimulation patch, and the distance between them may be determined individually, such as to have these stimulators stimulate e.g. by kneading and/or vibrating different areas of the organ or part thereof over which they are placed.

[0032] According to some embodiments, the base structure of the stimulation patch may be configured as a patch having an adhesive coating layer on one side thereof for attaching the device to the body area or coupled thereto via a sleeve dressed over the patient's limb (depending on the area).

[0033] According to some embodiments, the base structure of the stimulation patch is configured to allow adjusting the number, location and type of stimulators installed thereover and the locations thereof such as to allow adapting the device to the particular body area of the patient and to the locations of the various tissue types to be stimulated. For example, the stimulation patch's base structure may have a matrix of recesses or openings that allow placing therein a stimulator for holding thereof in the respective recess or opening allowing removing and placing the stimulators at will for adapting their positioning in the patch to the body area of the specific patient depending on the location of nerve and muscle tissue in that area.

[0034] Different areas in the body of the patient may require placing the stimulators at different locations for having at least the optical stimulator(s) of the device direct their optical signal towards clusters of peripheral nerve cells such as ganglia areas and/or at least the tactile stimulators vibrate muscle tissue areas. The operation of the different stimulators may be controlled via a controller which may enable simultaneous operation of several stimulators of the same and/or different types at various operational modes, intensities and the like, depending on the particular patient, the particular treatment and body area and the like. Optionally the controller may control sequential operation of the stimulator according to defined schedule.

[0035] All stimulators are nonintrusive and therefore can only stimulate inner tissues or cells externally and some will therefore require close proximity to or direct contact with the skin of the patient for optimal stimulation.

[0036] Reference is now made to Figure 1A, schematically illustrating a system 100 for application of stimuli of multiple stimulation types over a body area for therapeutic purposes such as pain alleviation and/or treatment of causes thereof, according to some embodiments of the present invention. The system 100 includes one or more stimuli devices such as stimulation patch 110 having one or more stimulators for each of at least three stimulator types: tactile, electrical and optical for application of different types of stimuli over the body area over which the stimulation patch 110 is placed either simultaneously or in a synchronized or sequentially according to predefined schedule . The patch 110 may be designed for directing the stimuli of each type of stimulator to a specific location within this body area of the patient for example for stimulating nerve and/or muscle tissue thereof.

[0037] According to some embodiments, the system 100 further includes a micro controller 111 for controlling the operation of the stimulators mounted on the stimulation patch 110 and optionally, in case the system incorporates multiple stimulation patches, for controlling the operation of all the stimulators, mounted upon all stimulation patches 110 of the system that are required for the therapeutic treatment.

[0038] According to some embodiments, the micro controller 111 may be connectable to a touch screen device 112 and / or a system panel 113 or any other display, power and control device for enabling a caregiver to control the operation modes of the stimulators of each connected stimulation patch 110 device, to power the controller 111 and/or the stimulation patch(es) 110 and the like.

[0039] According to some embodiments, as shown in Figure 1A, the stimulation patch 110 includes a pair of stimulator sets: each set comprising two vibration tactile motorized stimulators (each having its own motor), six TENS electrodes and three laser diodes as optical stimulators. Each diode emits light in a different wavelength for applying different stimuli over the same area.

[0040] The stimulation patch 110 is designed such that in each pair the TENS electrodes are located in two rows at the edges of the patch such that a cluster of the laser diodes and the tactile stimulators are located in between those rows and the tactile stimulators are positioned each on a different side of the laser diodes cluster. Each stimulator can be separately controlled for having as many possible combinations of operational modes thereof i.e. optimal intensities and/or frequency control.

[0041] The conductivity of human skin is affected by a variety of parameters (e.g.: sweat, temperature, application of body lotions etc.). High skin impedance may diminish the effectiveness of the stimuli treatment. According to some embodiments of the present invention, the stimulation patch 110 incorporate two probe electrodes for measuring the electric skin impedance. Skin impedance measurements affect the stimuli treatment in at least one of the following manners:

• In case high skin impedance is measured, some moisturizing gel or lotion may be applied to the patient' s skin to reduce impedance prior to the treatment.

· Areas of low skin impedance correlate with improved IR laser energy penetration. The impedance measurement is therefore included as a parameter in determining the position of the stimulation patch.

• Skin impedance data is propagated to the microcontroller, and is taken into account in the process of electrical and optical stimulation signal setting. • The microcontroller propagates the skin impedance information to the online Sever 200. The said server 200 includes this data in the logging of specific treatment sessions, correlates it with additional data (e.g. patient feedback) and optionally provides insight regarding preferred treatment parameters (e.g. stimulus signal properties) for groups of users.

[0042] In other embodiments, the tactile stimulators can be located in the center while the laser diodes in the patch periphery depending on location of muscle and nerve tissue of the particular organ or part thereof over which the patch is to be placed.

[0043] It has been demonstrated in prior art that TENS stimulus may alleviate pain sensation by reducing the signal-to-noise ratio (SNR) of the conducted pain signal. According to some embodiments of the present invention, the TENS electrode's position and density will be set such as to produce this SNR- reduction effect, according to the surface area of the body organ they are required to cover.

[0044] According to some embodiments, the base structure is designed such as to include a matrix or other configuration of multiple recesses or holes in which the stimulators and electrodes are to be inserted or mounted, thus determining their location by selecting the holes/recesses to be used. This design facilitates the positioning of the stimulators (e.g. TENS electrodes), and enables adaptation of their position according to the specific patient and body part being treated.

[0045] Additionally or alternatively, the same number and positions of stimulators (e.g. TENS electrodes)can be mounted on the stimulation patch, but their effective density and positioning will be determined by simply

disconnecting or disabling some of them, and enabling or connecting only the ones that are needed according to the required treatment.

[0046] According to some embodiments, the controller can be adapted to collect data indicative of treatment properties such as timing, intensities and frequencies of stimulators. [0047] According to some embodiments, the controller may be adapted to collect treatment feedback data from the treated patient. This feedback may, for example, include data pertaining to at least one of the following sensory thresholds:

· lower threshold of sensitivity to electric stimulus

• lower threshold of sensitivity to tactile stimulus

• threshold for sensation of pain, induced by electric stimulus

[0048] According to one embodiment, the electrical sensitivity and pain thresholds are determined by applying electric stimulus of various waveforms (e.g. AC current of 5Hz and 200 Hz frequencies), while gradually increasing the electric current. This procedure will determine the patient' s electrical sensitivity threshold, followed by their electrical pain threshold.

[0049] According to another embodiment, the tactile stimulator is employed to determine the patient's tactile sensitivity threshold. This information is useful for patients that suffer from neuropathic pain due to Diabetes Melitus.

[0050] This said sensitivity and pain threshold data is stored and used for future follow up on the patient's condition. Decreased sensory thresholds and increased pain thresholds would reflect an improvement in the patient's condition with regard to their pain syndrome.

[0051] According to some embodiments, the controller may be adapted to send the collected data (e.g. said properties of the treatment and patient feedback) via a wireless or wired communication module 114, to a cloud based data server 200. The said data server 200uses this information for improving treatment programs, based on

• Aggregated data pertaining to individual patients, and

• Optional aggregated statistical data gathered from multiple individuals treated with the same devices and having the same or similar medical condition. Optionally, the data server 200 is also adapted to produce reports to each patient showing treatment progress and aspects thereof.

[0052] Figure IB shows an exemplary implementation of the system 100 for application of stimuli of multiple stimulation types over a body area, according to one embodiment of the present invention. Figure 2 shows a noninvasive stimulation patch 10 for application of stimuli over one or more body areas of a patient, according to some embodiments of the invention. The stimulation patch 10 has six TENS electrode stimulators 12a- 12f arranged at the periphery of a support member 15 of the device in two rows; a cluster 13 of optical stimulators with three laser diodes stimulators 13a- 13c each configured to emit light at a different wavelength/frequency located substantially at the center of the support member 15 between the rows of the electrode stimulators 12a-12f; and two tactile stimulators 11a- lib located on sides of the cluster 13 of diodes.

[0053] In some embodiments, more than one infrared (IR) laser diode stimulator, each bearing a different laser radiation wavelength are employed simultaneously. Such a configuration is required to meet the different response of different tissues to different laser wavelengths.

[0054] According to some embodiments, the emittance of laser radiation per each of the laser diode stimulators (13a- 13c) is controlled by the microcontroller 111, according to a predefined protocol. The said protocol dictates the timing and power of each laser diode emittance. For example, the laser diodes (13a- 13c) may be set to emit laser radiation simultaneously, or serially or in an arbitrary manner, and their power may be set to a constant level or be modulated according to a predefined function.

[0055] Each vibration stimulator 1 la/1 lb has its own motor separately controlled and operated. All stimulators 11a, lib, 12a, 12b, 12c, 12d, 12e, 12f, 13a, 13b and 13c are located such as to be in close proximity to or even in direct contact with the skin when the device 10 is placed over the body area of the patient for optimal stimuli thereof. [0056] According to some embodiments, the function of each of the different stimulators (11a, lib, 12a, 12b, 12c, 12d, 12e, 12f, 13a, 13b and 13c) is controlled by the microcontroller 111, according to a predefined protocol. The said protocol dictates parameters such as the timing, power, frequency, duty- cycle of each of the said stimulators. For example, specific laser diodes (13a- 13c) may be set to emit laser radiation in conjunction with the operation of specific TENS electrodes, and in conjunction with the operation of specific tactile stimulators.

[0057] Reference is now made to Figures 3A and 3B showing two stimulation patches 20 and 30 placed over a stump 101 of a patient, each device designed according to some embodiments of the invention and according to the body area over which it is intended to be placed over: the first stimulation patch 20 is located at the anterior side of the stump 101 and the second stimulation patch 30 is located at the posterior side of the stump 101. These devices 20 and 30 can be used for treatment of phantom limb pain, residual limb pain / stump pain following limb amputation by appliance of the stimulators thereof in a preset synchronized, simultaneous or sequential order.

[0058] Each stimulation patch such as device 20 has six TENS electrodes 22a-22f located in two rows, each row located peripherally over a different side of a rectangular patch like support structure 25 of the device 20 for providing tactile stimuli over the muscle of the thigh stump 101; two tactile vibration stimulators 21a and 21b each having a separate motor for producing the tactile stimulation by vibrating an element thereof each tactile stimulator located at a different side of the support member 25 at the periphery thereof; and a cluster of laser diodes 23 of three diodes each emitting light of a different wavelength located at the center of the patch like support member 25. The tactile stimulators 21a and 21b are located such as to stimulate muscles in the stump 101 such as the quadriceps and/or adductor muscles while the optical stimulators (laser diodes) of the cluster 23 are located such as to stimulate peripheral nerve clusters of the stump by directing light thereto. [0059] The stimulation patches 20 and 30 may be attached to the limb stump by using one or more bands such as elastic bands or adhered to the stump via adhesive means.

[0060] For treating post amputation pain such as phantom pain the treatment using these devices may begin before amputation if possible as a preemptive measure and continue after amputation.

[0061] According to some embodiments, the position of each patch device such as 20 and/or 30 being used is decided at first according to a general assessment of positioning of muscles and peripheral nerve ganglia of the limb stump and then may be adapted according to feedback from the patient (patient) for improving treatment effectiveness. Adjustment of properties of each of the stimulators may also be possible according to feedback from the patient using the stimulation patch (s) by for example adjusting the location of the stimulators over the patch support member, removing or adding stimulators, adapting the intensity of the stimulation, adjusting wavelength of the optical stimulation, adjusting the timing of operation of each of the stimulators, adjusting the frequency of vibration of the tactile stimulators, adjusting frequency of the electric current, voltage and/or amperage of the TENS electrodes and the like.

[0062] Reference is now made to Figure 4 showing a stimulation patch 40 placed over a wrist 102 of a patient for carpal tunnel syndrome treatment, according to some embodiments of the present invention. Similarly to the devices 20 and 30, this stimulation patch 40 has six TENS electrodes 42a-42f, two tactile stimulators 41a and 41b having motors for producing vibrations; and a cluster of laser diode optical stimulators 43 all arranged over a patch like support member 45 of the stimulation patch 40 configured for being placed over the carpal tunnel area on the wrist 102 such that optical signals from the diodes cluster 43 will be directed to median nerve ganglia and the tactile stimulators 41a-41b will vibrate in proximity to the muscle surrounding thereof. The tactile stimulators 41a and 41b will be placed over the thenar and hypothenar eminence of the wrist 102 and the cluster 43 of diodes right above the carpal tunnel for stimulating its median nerve ganglia.

[0063] According to some embodiments, a designated elastic band or a glove or guard may be used for attaching the device 40 to the patient's wrist for maintaining the wrist in an extended posture or semi-extended posture preventing it from folding.

[0064] The size and shape of the support member 45 as well as locations of the stimulators mounted on the stimulation patch 40 are adapted to the particular wrist of the particular patient (several optional sizes may be available for different hand sizes).

[0065] Reference is now made to Figures 5A and 5B, showing a cylindrical contraption 500, which incorporates a series of stimulation patches (three in this example; 40a, 40b, 40c), and may be worn by the patient as a bracelet, according to some embodiments of the present invention. The design of bracelet is an example , the device may be shaped in any circular design which fits the respective organ being treated.

[0066] Figure 5B is a blown perspective image of the stimulation patches presented in Figure 5A.

[0067] The distance between the stimulation patches (40a, 40b, 40c) incorporated in the said bracelet 500 is adjustable, to fit the patient organ size and the required treatment.

[0068] Each stimulation patch (40a, 40b, 40c) presented in this embodiment incorporates:

• A central area, containing three low light, IR laser emitting diodes

(e.g. in the range of 700nM, 800nM and 900nM)

• Six electrical, TENS stimulation electrodes, and

• Two Vibro-tactile stimulators.

[0069] In the case of patients that suffer neuropathic pain, the three central laser emitting diodes will be attached to the skin overlying the presumed pathway of a major peripheral nerve 102b. [0070] The orientation of the stimulation patches will be determined by the ability to induce paresthesia, due to the proximity of the TENS stimulation electrodes to the Laser diodes.

[0071] The treatment of such patients will therefore require to:

· Identify the nerve or nerves that are involved in the pathogenesis of the neuropathic pain,

• Locate the central laser emitting diodes accordingly,

• Orient the stimulation patches such as to maximize paresthesia in

the sensory distribution of a nerve or nerves involved in the

evolution of the neuropathic pain syndrome.

[0072] In the case of patients that suffer from a myofascial pain syndrome, the stimulation patches will be applies such as to maximize the vibro-tactile stimulation of the involved muscle or muscles.

[0073] Reference is now made to Figure 6 showing two stimulation patches 50 and 60 placed over the back of a patient's head 103 for pain treatment and/or prophylaxis treatment for headaches such as for tension type headache or migraines, according to some embodiments of the present invention. Similarly to devices 20-40, the each of the stimulation patches 50 and 60 has a patch like support member 55 and 65; two tactile stimulators 51a-51b and 61a-61b, respectively; six TENS electrodes 52a-52f and 62a-62f ; and a cluster 63 and 63 containing multiple optical stimulators (e.g. laser diodes of different wavelength emission).

[0074] These stimulation patches 50 and 60 will be placed over the occipital area overlaying the greater occipital nerves and/or over the parietal area.

[0075] Figure 7 shows two stimulation patches 71 and 72 each having only the tactile and TENS electrode stimulators (lacking the optical stimulators) placed over the forehead 104 of a patient for headache alleviation and/or treatment, according to some embodiments of the present invention. These devices 71 and 72 may be used as additional devices to 50 and 60 for headache prevention and/or treatment. The two auxiliary stimulation devices 71 and 72 may be positioned over the forehead above the eyebrows.

[0076] Reference is now made to Figure 8 showing two stimulation patches 80 and 90 placed over the foot 105 of a patient for treatment of neuropathic and /or ischemic pain for patients for example with a diabetic foot, according to some embodiments of the present invention. This treatment may also require placing additional one or more stimulation patches over the patient's thighs.

[0077] Each of the stimulation patches 80 and 90, respectively, includes: a support member 85 and 95; TENS electrode stimulators 82a-82f and 92a-92f; vibration tactile stimulators 81a-81b and 91a-91b; and clusters 85 and 95 of laser diode optical stimulators.

[0078] According to these embodiments, one of the stimulation patches i.e. stimulation patch80 is positioned over the inner side of the foot 105 for stimulating the nerves and muscles therein in designated areas over the foot 105. Again, the tactile stimulators 81a-81b and 91a, 91b are located such as to be in close proximity to muscle tissue whereas the optical stimulators 83 and 93 located to stimulate nerve ganglia.

[0079] The devices and systems of the present invention allow regular and regulated treatment by placing the one or more stimulation patches over the body area to be treated and operating the patch(es) on a routine basis such as once or several times a day, where the treatment frequency is decided according to the medical condition and the progression of the treatment, optionally based on patients' feedback.

[0080] A treatment may involve changing the locations of the stimulators over time and not just the treatment frequency or changing other properties of the stimulators such intensities and frequencies and/or timing of the stimulators and the like.

[0081] Each stimulation patch device of the present invention may be connected to an external power source, or be powered by a battery. [0082] Each stimulation patch device of the present invention may be controlled via an external separate control or an embedded controller (e.g. micro controller using MEMS) and settable via one or more external and/or internal embedded input and output means for adjusting stimulators operational properties therethrough, checking power status of the device(s) and the like.

[0083] Other types of stimulators may be embedded in one or more of the stimulation patches controllable via the controller of the system/device.

[0084] According to some embodiments, each device may be programmable such as to adapt the stimulation of the stimulators to the specific patient e.g. by setting the stimulation frequency, timing, intensity, pulse shape, duty cycle and the like of each stimulator. The settings layout for each particular patient will be referred to herein as the protocol of each patient.

[0085] Optionally, each device also includes a communication unit capable of wireless or linear communication with a system controller, a mobile device including a designated application for controlling the stimulation device. For example a radio frequency (RF) based transceiver operatively associated with the stimulators of the device for operating thereof according to commands received from a remote controller.

[0086] According to some embodiments, the device may also include communication means for communicating with one or more external remote devices each using a designated application for reading stimulators' related data, for controlling the stimulators and/or also for allowing the patient or a user associated with the patient using the device to input feedback therethrough, e.g. via a designated graphical user interface (GUI) of the application.

[0087] For example, the patient may be able to input feedback in real time regarding the stimulation applied to his/her body part indicating, for instance, whether the stimulation is painful (i.e. stimulation level). The application may be designed to adapt the stimulation according to the patient's real time feedback by controlling the stimulators of the device. The adaptation may be automatically done by the application using various predefined algorithms designed to calculate the adaptation required according to input feedback and/or manually be the patient.

[0088] Additionally or alternatively, the application is designed to receive off-line feedback over long periods of time for determining whether the stimulation protocol as applied on the specific patient should be modified or whether it fits the patient and requires no further adaptations.

[0089] The ability of the application to collect feedback data may also be used for statistical calculations and/or for "learning" the patient's needs for further adjustment of the parameters of the stimulators.

[0090] The remote device may be any device known in the art such as a PC computer, a tablet device, a Smartphone and the like and may be used by one or more users such as the patient or a professional caretaker thereof (e.g. his/her physician, physiotherapist and the like) for allowing them to adjust the stimulation parameters to fit to the specific body area and patient in the most optimal manner.

[0091] Figure 9 shows an exemplary graphic user interface (GUI) screenshot indicating the stimulators' states and optionally allowing a user such as a professional caretaker and/or the patient to set the stimulators' properties such as intensities, frequency of stimulation (timing), pulse parameters and the like, according to some embodiments of the invention.

[0092] Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following invention and its various embodiments and/or by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the invention is explicitly contemplated as within the scope of the invention.

[0093] The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.

[0094] The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a sub-combination or variation of a subcombination.

[0095] Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.

[0096] The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.

[0097] Although the invention has been described in detail, nevertheless changes and modifications, which do not depart from the teachings of the present invention, will be evident to those skilled in the art. Such changes and modifications are deemed to come within the purview of the present invention and the appended claims.

Claims

CLAIMS OF THE PRESENT INVENTION

1. A noninvasive device for application of stimuli over one or more body areas of a treated patient, for the purpose of alleviating pain or providing therapeutic affect, said device incorporating at least one stimulator of the following types:

d) tactile stimulator, adapted to produce movement for applying tactile stimulation;

e) optical stimulator, for applying stimulation by outputting optical signals within at least one frequency range;

f) electric stimulator, applying stimulation by emitting electric current between at least two electrodes;

wherein the said device further incorporates:

• a base structure designed to attach to, or be placed over an at least one treated body area of a treated patient and for holding the stimulators of the device; and

2. The device of claim 1, wherein the said base structure is configured such as to allow adjustment of the stimulator types and the number of stimulators, according to the required treatment, the particular treated body area and the particular patient.

3. The device of claim 1, wherein the said base structure is configured such as to allow adjustment of the stimulator locations and stimulator density, according to the required treatment, the particular treated body area and the particular patient, such that: a. each optical stimulator is accurately located to direct

optical radiation therefrom to nerve tissue of the treated body area,

b. each pair of electrodes is oriented to apply electric

stimulus therefrom to nerve tissue of the treated body area, and

c. each tactile stimulator is accurately located to apply

tactile stimulation to muscle tissue of the treated body area.

4. The device of claim 1, wherein the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol, said protocol determining at least one of the following parameters:

• power

• schedule

• frequency

• duty-cycle

5. The device of claim 1, wherein the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling simultaneous operation of at least some of the stimulators.

The device of claim 1, wherein the at least one controller controls and

synchronizes the operation of more than one stimulator device,

according to a predefined protocol enabling sequence scheduled operation of at least some of the stimulators.

7. The device of claim 1 , wherein the at least one controller accumulates patient- specific feedback and treatment- specific data for analysis, either locally or on a cloud-based data server, such as to produce optimal treatment protocols for both individual patients and for groups of patients.

8. The device of claim 1 , wherein the at least one controller accumulates patient- specific data pertaining to the patient's sensitivity and pain thresholds in relation to at least one of the following stimuli:

• lower threshold of sensitivity to electric stimulus

• lower threshold of sensitivity to tactile stimulus

• threshold for sensation of pain, induced by electric stimulus wherein the said sensitivity and pain threshold data is stored and used for future follow up on the patient's condition.

9. The device of claim 1, wherein the said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein low skin impedance areas correlating with improved IR laser energy penetration are selected for applying said optical stimulation,

10. The device of claim 1, wherein the said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein skin impedance data is propagated to said microcontroller, and is taken into account in electrical and optical stimulation signal setting.

11. The device of claim 1 , wherein the said device further incorporates at least two probe electrodes for measuring the electric skin impedance, wherein , said microcontroller propagates the skin impedance information to an online Sever, which: includes this data in the logging of specific treatment sessions, correlates it with additional treatment- specific data, and produces optimal treatment protocols for groups of users

12. The device of claim 1 wherein the device is designed in cylindrical shape, which incorporates a series of stimulation patches , such that the distance between the stimulation patches is adjustable, to fit the patient organ size and the required treatment.

13. A method for alleviating pain or providing therapeutic affect by

applying noninvasive stimuli using at least one controller, over one or more body areas of a treated patient, for the purpose of alleviating pain or any other therapeutic purpose, said stimuli incorporating at least one of the following stimulus types:

• electrical,

• optical, and

• tactile,

• applying the said optical stimulus to nerve or nerves of the treated body area that are involved in the pathogenesis of neuropathic pain • applying the said electrical stimulus so as to maximize paresthesia in the sensory distribution of a nerve or nerves involved in the evolution of neuropathic pain, and

14. The method of claim 13, wherein the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol, said protocol determining at least one of the following parameters:

• power

• schedule

• frequency

• duty-cycle

15. The method of claim 13, wherein the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling simultaneous operation of at least some of the stimulators.

16. The method of claim 13, wherein the at least one controller controls and synchronizes the operation of more than one stimulator device, according to a predefined protocol enabling sequence scheduled operation of at least some of the stimulators.

17. The method of claim 13 wherein the at least one controller

accumulates patient- specific feedback and treatment- specific data for analysis, either locally or on a cloud-based data server, such as to produce optimal treatment protocols for both individual patients and for groups of patients.

18. The method of claim 13, wherein the at least one controller

accumulates patient- specific data pertaining to the patient's sensitivity and pain thresholds in relation to at least one of the following stimuli:

• lower threshold of sensitivity to electric stimulus

• lower threshold of sensitivity to tactile stimulus

19. The method of claim 13 wherein the design of the stimulators patches is adjustable before treatment by applying the following steps:

- Identify the nerve or nerves that are involved in

the pathogenesis of the neuropathic pain;

- Locate the central laser emitting diodes

accordingly; and