Patent Application
20140249466
The present invention relates generally to a system and method for a manipulation of the thermoregulation of a mammalian body's temperature.
Temperature management of the body is crucial to patient lives. Optimizing temperature management improves patient outcome and reduces health care cost.
The natural body thermoregulation system is a complicated mechanism for maintaining stable core body temperature. The hypothalamus contains control mechanisms and key temperature sensors. Under control of these mechanisms, sweating begins almost precisely at a skin temperature of 37° C. and increases rapidly as the skin temperature rises above this value. The heat production of the body under these conditions remains almost constant as the skin temperature rises. If the skin temperature drops below 37° C. a variety of responses are initiated to conserve the heat in the body and to increase heat production. These include vasoconstriction to decrease the flow of heat to the skin, cessation of sweating, shivering to increase heat production in the muscles, and secretion of norepinephrine, epinephrine and thyroxine to increase heat production. Messages from the brain reach effectors. For example, the trigger to shivering is correlated to core temperature drop. Messages reach muscles and glands, via the motor neurons.
During surgical operations, the body's core temperature can drop due to the re-distribution of heat from the body's core to peripheral tissue, due to the vasodilating effect of anesthesia drugs and due the lack of protective vasoconstriction. Many patients, about 70%, become hypothermic, post surgery. Hypothermia becomes clinically significant in operations longer than two hours and leads to increased patient morbidity and healthcare costs.
In some clinical indications however, where there is ischemic stress or other stresses such as toxic metabolites in the brain, the heart, kidney or liver, such as a stroke, Cardiac Arrest (CA), Traumatic Brain Injury (TBI), Acute Myocardial Infarction (AMI), Contrast induced nephropathy, Acetaminophen-induced liver failure, the intentional induction of hypothermia was found to be a therapeutic option. The benefits of cooling were found to be greater than the risks, and it was shown that the chance for the patient's of recovery is increased.
For example, current devices use external heat exchange apparatus without coping with the body's thermoregulation physiological responses. Other devices and methods are invasive and complicated, and can be applied only at the hospital's emergency room, and critical time may be lost.
External heat exchange modules or energy affects the peripheral thermal sensors. Heat is transferred in or out via convection, through the blood. Drugs are used to modulate the thermoregulation system. Heat transfer is restricted due to limits in temperature level that may be safely applied and thermoregulation system resistance.
As disclosed in the following description, there are many known methods for controlling the body's thermoregulation system using: heat transfer or administration of medication. However, there is still a significant need to provide means for non-invasively controlling the main thermostat system of the body, without cumbersome external heat/cooling transfer or medication.
Dobak U.S. Pat. No. 6,364,899 offers a solution for pain control and discloses a heat pipe to a spinal cord of a patient, for producing reversible focal hypothermia of the nervous system to control chronic pain. Nerve conduction is blocked by mild cooling, or hypothermia.
Holsheimer U.S. Pat. No. 5,643,330 discloses an apparatus for providing a number of superimposed current generated electrical fields for epidural spinal cord stimulation. The pulses given, by the stimulator channels, are selectably simultaneous or alternate in time, are selectably equal or different in amplitude, or both, permitting the shifting the electrical field after implantation to optimize paresthesia effects (abnormal sensation, imaginary sensation) or to eliminate unwanted motor responses.
Dae U.S. Pat. No. 6,572,638 discloses a method and apparatus for controlling the body temperature of a patient, while reducing shivering by using a heat exchange device in combination with an anti-thermoregulatory response mechanism including various anti-thermoregulatory response agents that temporarily reduce shivering. The devices disclosed include a catheter having a heat exchange balloon thereon with heat exchange fluid circulating through the interior of the balloon, placed in the vasculature of a patient, in order to add or remove heat from the blood of the patient. The system includes a control for controlling the patient's temperature in conjunction with administering the anti-thermoregulatory response mechanism.
Diller US20110066217 discloses a method for increasing or maintaining temperature of glabrous tissue in a subject, by applying heat to peripheral thermoregulatory control tissue of the subject, where the applied heat increases or maintains perfusion of blood in the glabrous tissue; method further includes negative pressure to the glabrous tissue. Said peripheral thermoregulatory control tissue is located in the cervical spinal region or in the lumbar spinal region of the subject. In other aspects, Diller discloses cooling stimulus that can be applied to the glabrous tissue with the increased or maintained perfusion. When a cooling stimulus is used, the core temperature of the subject can be reduced. When a warming stimulus is used, the core temperate of the subject can be increased.
Carson U.S. Pat. No. 6,799,063 discloses a dual function medical pad is disclosed for both controlling patient temperature and providing a patient-to-electrode interface. The pad includes a fluid containing layer for containing a thermal exchange fluid circulated there through, operable for thermal exchange with a patient. Further electrodes interconnected to the fluid containing layer, such as electrosurgical return electrodes, EKG electrodes, pacing or defibrillation electrodes.
Grahn U.S. Pat. No. 7,947,068 discloses a method for controlling the temperature of all or a portion of a patient's body, while achieving thermoregulatory inhibition. The method includes sensing the temperature of all or a portion of the patient's body and controlling the temperature of all or a portion of the patient's body based upon the signal by placing a heat exchange device having a heat exchange region into heat exchange proximity with the patient's body and controlling the temperature of the heat exchange region for a sufficient time to affect the temperature of all or a portion of the patient's body; and further by administering a therapeutically effective amount of an anti-thermoregulatory response agent to the patient for the inactivation of the shivering response and for the inhibition of vasoconstriction.
Flint US20100087900 discloses a method for quantifying shivering in a subject, by obtaining and analyzing signals from a muscle mass that is susceptible to shivering; the signals include an ECG component and an EMG component. Flint further discloses a method for treating shivering in a subject in the course of therapeutic temperature regulation for inhibition of shivering, to areas such as: hands, feet, ears, upper back or posterior neck. Flint further discloses a method for applying active counterwarming to a subject during therapeutic temperature regulation for a patient; cooling apparatus may include a cooling blanket, cooling pads, and an endovascular cooling catheter.
Pan-Li CN101920066 discloses a wearable electrical stimulation system for wearing on a shivering limb, for pathological tremor suppression. The system includes: a wearable binding structure, an electromyographic sensing device, an information processor, a controller and an actuator.
Louise US20110125205 discloses a thermo-stimulation system for providing electrical currents for thermal and electrical stimulation including a plurality of thermo-stimulation pads regulated in response to a temperature feedback by an inline control system. The system is designed for a variety of therapeutic applications, such as heat therapy and thermo-stimulation using electrical stimulation application a single or a group of muscles. The resulting contraction can produces a variety of effects from strengthening injured muscles and reducing oedema to relieving pain and promoting healing.
It is clear from the above that there remains a long felt and unmet need to provide improved and more comprehensive means and methods of artificially controlling the body temperature of a patient in need. The present invention as will be further detailed in the description, discloses a novel system for manipulating the body thermoregulation system, without the use of a thermal stimuli for body temperature control, as seen in the prior art.
It is one object of the present invention to provide a system [1] for controlling and modulating a mammalian's body temperature and thermoregulation system, comprising:
It is another object of the present invention to provide the system [1] as defined above, wherein said a pulse generator [10] is selected from the group consisting of:
It is another object of the present invention to provide the system [1] as defined above, wherein said MAC unit is at least one unit selected from the group consisting of:
It is another object of the present invention to provide the system [1] as defined above, wherein said MAC units are further adapted to analyze said measured physiological signals as feedback signals for monitoring said applied pulse stimulating procedure, and command said control panel [20] accordingly.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to command at least one predetermined pulse stimulating procedure selected from the group consisting of:
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units regulate said stimulating procedures of electric pulses by means of current's amplitude [A], frequency [F] and phase [φ], applied to said selected channels of electrical or electromagnetic stimuli.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequency [F] in the range of about 0 to about 30,000 [Hz].
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequencies' [F] beat in the range of about 0 to about 1000 [Hz].
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are configured to implement said stimulating procedures in cycles which said frequencies' [F] beat are not constant between cycle to cycle.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequency [F] in a manner selected from the group consisting of: linear, nonlinear, sinusoidal, or any combination thereof.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are configured to implement said stimulating procedures in intervals which range from about 0 to about 300 [sec].
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to implement said pulse stimulating procedure for blocking the temperature signals traveling from the entire body or selected body parts from reaching the brain, thereby isolating the thermoregulation system from reacting to changes in skin or core temperature
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to implement said stimulating procedure adapted to control and modulate said body's thermoregulation system to at least one of the following:
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to implement said stimulating procedure adapted to control and modulate said thermoregulation system physiological responses such as: vasodilatation, vasoconstriction of blood vessels, shivering or heart rate, by affecting the efferent neurological pathways.
It is another object of the present invention to provide the system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are configured for predetermined location selected from the group consisting of: topically close to the spinal cord, remote from said spinal cord, transcutaneously, or by means of minimally invasive means to said spinal cord, or any combination thereof.
It is another object of the present invention to provide the system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are configured to be attached to said body using at least one patch [6].
It is another object of the present invention to provide the system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Electro-Cardio-Graph (ECG) signals.
It is another object of the present invention to provide the system [1] as defined above, wherein said least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Neuro-Electric signals.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to command said stimulation procedure along the whole length of the spinal cord or selected segments thereof, according to required treatment and clinical need.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to command and implement said stimulation procedure for controlling said body's temperature and thermoregulation system for the entire body or selected body parts.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said MAC units are adapted to command said stimulation procedure for simultaneously controlling said selected body parts, each for normo-thermia, hyper-thermia or hypo-thermia.
It is another object of the present invention to provide the system [1] as defined above, wherein said system [1] further comprises means for the application of medication such as: local or general anesthetics, analgesics and or sedation agents, muscle blocking or relaxants agents, pain blocking agents, consciousness impairing agents.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] controls said application of stimulation procedure automatically.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] controls said application of stimulation procedures at least partially manually.
It is another object of the present invention to provide the system [1] as defined above, wherein said display monitor [30] is configured to display parameters selected from the group consisting of: said MAC units measurements, said MAC units analysis results, said MAC units command for said stimulating procedures, said control panel [20] optional said stimulating procedures, said control panel [20] said administrated stimulating procedure, or any combination thereof.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20] and said display monitor [30] are combined into a single device, such as a touch screen.
It is another object of the present invention to provide the system [1] as defined above, wherein said control panel [20], said display monitor [30] and said pulse generator [10] are combined into a single device.
It is another object of the present invention to provide the system [1] as defined above, wherein said at least two MAC units are activated simultaneously, said control panel [20] consequent upon the first MAC unit that requires a change in generation of said pulse stimulating procedure.
It is another object of the present invention to provide the system [1] as defined above, wherein said HRV unit [50] further comprises: an HRV receiving unit [51], an HRV analysis unit [52], an HRV activating unit [53] and an HRV output pulse generator [59].
It is another object of the present invention to provide the system [1] as defined above, wherein said EMG unit [60] further comprises: an EMG receiving unit [61], an EMG analysis unit [62], an EMG activating unit [63], an EMG identification unit [65] and an EMG output pulse generator [69], as shown in
It is another object of the present invention to provide the system [1] as defined above, wherein said temperature measuring unit [70] further comprises: a skin receiving unit [71s], a core receiving unit [71c], a temperature measuring analysis unit [62], a temperature measuring activating unit [73] and a temperature measuring output pulse generator [79], as shown in
It is another object of the present invention to provide the system [1] as defined above, wherein said oxygen utilization (Vo2) measuring unit [80] further comprises: a Vo2 receiving unit [81], a Vo2 analysis unit [82], a Vo2 activating unit [83] and a Vo2 output pulse generator [89], as shown in
It is another object of the present invention to provide the system [1] as defined above, wherein said neuro-signal unit [90] further comprises: a neuro-signal receiving unit [91], a neuro-signal analysis unit [92], a neuro-signal activating unit [93], a neuro-signal identification unit [95], a neuro-signal summing unit [96] and a neuro-signal output pulse generator [99], as shown in
It is another object of the present invention to provide the system [1] as defined above, wherein said system [1] further comprises at least one Heat Exchange Unit (HEU) [100] for heating or cooling said body.
It is another object of the present invention to provide the system [1] as defined above, wherein said HEU [100] further comprises: at least one thermal sensor [101], an HEU analysis unit [102], an HEU activating unit [103] and at least one of the following:
It is another object of the present invention to provide the system [1] as defined above, wherein said heaters [105] or said coolers are placed on a body part selected from the group consisting of hand palms, feet soles, wrapped around large body parts, or any combination thereof.
It is another object of the present invention to provide the system [1] as defined above, wherein said least one pair of stimulating electrodes [5] are configured to be placed parallel to the vertebral column and over the intervertebral foramen, thereby enabling stimulation of the appropriate roots of spinal nerves which supply the affected dermatome.
It is another object of the present invention to provide the system [1] as defined above, wherein said least one pair of stimulating electrodes [5] layout in relation to the spinal cord vertebrates in a configuration selected from the group consisting of:
It is another object of the present invention to provide a method for controlling and modulating a mammalian's body temperature and thermoregulation system, said method comprising steps of
It is another object of the present invention to provide the method as defined above, wherein said method further comprises the step of analyzing the input signals from said HRV unit in time and in frequency domains.
It is another object of the present invention to provide the method as defined above, wherein said a pulse generator [10] is selected from the group consisting of:
It is another object of the present invention to provide the method as defined above, wherein said MAC unit is at least one unit selected from the group consisting of:
It is another object of the present invention to provide the method as defined above, wherein said MAC units are further adapted to analyze said measured physiological signals as feedback signals for monitoring said applied pulse stimulating procedure, and command said control panel [20] accordingly.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to command at least one predetermined pulse stimulating procedure selected from the group consisting of:
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units regulate said stimulating procedures of electric pulses by means of current's amplitude [A], frequency [F] and phase [φ], applied to said selected channels of electrical or electromagnetic stimuli.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequency [F] in the range of about 0 to about 30,000 [Hz].
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequencies' [F] beat in the range of about 0 to about 1000 [Hz].
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are configured to implement said stimulating procedures in cycles which said frequencies' [F] beat are not constant between cycle to cycle.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are configured to regulate said frequency [F] in a manner selected from the group consisting of: linear, nonlinear, sinusoidal, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are configured to implement said stimulating procedures in intervals which range from about 0 to about 300 [sec].
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to implement said pulse stimulating procedure for blocking the temperature signals traveling from the entire body or selected body parts from reaching the brain, thereby isolating the thermoregulation system from reacting to changes in skin or core temperature
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to implement said stimulating procedure adapted to control and modulate said body's thermoregulation system to at least one of the following:
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to implement said stimulating procedure adapted to control and modulate said thermoregulation system physiological responses such as: vasodilatation, vasoconstriction of blood vessels, shivering or heart rate, by affecting the efferent neurological pathways.
It is another object of the present invention to provide the method as defined above, wherein said at least one pair of stimulating electrodes [5] are configured for predetermined location selected from the group consisting of: topically close to the spinal cord, remote from said spinal cord, transcutaneously, or by means of minimally invasive means to said spinal cord, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein said at least one pair of stimulating electrodes [5] are configured to be attached to said body using at least one patch [6].
It is another object of the present invention to provide the method as defined above, wherein said at least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Electro-Cardio-Graph (ECG) signals.
It is another object of the present invention to provide the method as defined above, wherein said least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Neuro-Electric signals.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to command said stimulation procedure along the whole length of the spinal cord or selected segments thereof, according to required treatment and clinical need.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to command and implement said stimulation procedure for controlling said body's temperature and thermoregulation system for the entire body or selected body parts.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said MAC units are adapted to command said stimulation procedure for simultaneously controlling said selected body parts, each for normo-thermia, hyper-thermia or hypo-thermia.
It is another object of the present invention to provide the method as defined above, wherein said system [1] further comprises means for the application of medication such as: local or general anesthetics, analgesics and or sedation agents, muscle blocking or relaxants agents, pain blocking agents, consciousness impairing agents.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] controls said application of stimulation procedure automatically.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] controls said application of stimulation procedures at least partially manually.
It is another object of the present invention to provide the method as defined above, wherein said display monitor [30] is configured to display parameters selected from the group consisting of: said MAC units measurements, said MAC units analysis results, said MAC units command for said stimulating procedures, said control panel [20] optional said stimulating procedures, said control panel [20] said administrated stimulating procedure, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20] and said display monitor [30] are combined into a single device, such as a touch screen.
It is another object of the present invention to provide the method as defined above, wherein said control panel [20], said display monitor [30] and said pulse generator [10] are combined into a single device.
It is another object of the present invention to provide the method as defined above, wherein said at least two MAC units are activated simultaneously, said control panel [20] consequent upon the first MAC unit that requires a change in generation of said pulse stimulating procedure.
It is another object of the present invention to provide the method as defined above, wherein said HRV unit [50] further comprises: an HRV receiving unit [51], an HRV analysis unit [52], an HRV activating unit [53] and an HRV output pulse generator [59].
It is another object of the present invention to provide the method as defined above, wherein said EMG unit [60] further comprises: an EMG receiving unit [61], an EMG analysis unit [62], an EMG activating unit [63], an EMG identification unit [65] and an EMG output pulse generator [69], as shown in
It is another object of the present invention to provide the method as defined above, wherein said temperature measuring unit [70] further comprises: a skin receiving unit [71s], a core receiving unit [71c], a temperature measuring analysis unit [62], a temperature measuring activating unit [73] and a temperature measuring output pulse generator [79], as shown in
It is another object of the present invention to provide the method as defined above, wherein said oxygen utilization (Vo2) measuring unit [80] further comprises: a Vo2 receiving unit [81], a Vo2 analysis unit [82], a Vo2 activating unit [83] and a Vo2 output pulse generator [89], as shown in
It is another object of the present invention to provide the method as defined above, wherein said neuro-signal unit [90] further comprises: a neuro-signal receiving unit [91], a neuro-signal analysis unit [92], a neuro-signal activating unit [93], a neuro-signal identification unit [95], a neuro-signal summing unit [96] and a neuro-signal output pulse generator [99], as shown in
It is another object of the present invention to provide the method as defined above, wherein said system [1] further comprises at least one Heat Exchange Unit (HEU) [100] for heating or cooling said body.
It is another object of the present invention to provide the method as defined above, wherein said HEU [100] further comprises: at least one thermal sensor [101], an HEU analysis unit [102], an HEU activating unit [103] and at least one of the following:
It is another object of the present invention to provide the method as defined above, wherein said heaters [105] or said coolers are placed on a body part selected from the group consisting of: hand palms, feet soles, wrapped around large body parts, or any combination thereof.
It is another object of the present invention to provide the method as defined above, wherein said least one pair of stimulating electrodes [5] are configured to be placed parallel to the vertebral column and over the intervertebral foramen, thereby enabling stimulation of the appropriate roots of spinal nerves which supply the affected dermatome.
It is another object of the present invention to provide the method as defined above, wherein said least one pair of stimulating electrodes [5] layout in relation to the spinal cord vertebrates in a configuration selected from the group consisting of:
It is another object of the present invention to provide another system [1] for controlling and modulating a mammalian's body temperature and thermoregulation system, comprising:
It is another object of the present invention to provide the other system [1] as defined above, wherein said a pulse generator [10] is selected from the group consisting of:
It is another object of the present invention to provide the other system [1] as defined above, wherein said measurement unit is at least one unit selected from the group consisting of:
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to command at least one predetermined pulse stimulating procedure selected from the group consisting of:
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] regulates said stimulating procedures of electric pulses by means of current's amplitude [A], frequency [F] and phase [φ], applied to said selected channels of electrical or electromagnetic stimuli.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is configured to regulate said frequency [F] in the range of about 0 to about 30,000 [Hz].
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is configured to regulate said frequencies' [F] beat in the range of about 0 to about 1000 [Hz].
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is configured to implement said stimulating procedures in cycles which said frequencies' [F] beat are not constant between cycle to cycle.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is configured to regulate said frequency [F] in a manner selected from the group consisting of: linear, nonlinear, sinusoidal, or any combination thereof.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is configured to implement said stimulating procedures in intervals which range from about 0 to about 300 [sec].
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to implement said pulse stimulating procedure for blocking the temperature signals traveling from the entire body or selected body parts from reaching the brain, thereby isolating the thermoregulation system from reacting to changes in skin or core temperature
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to implement said stimulating procedure adapted to control and modulate said body's thermoregulation system to at least one of the following:
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to implement said stimulating procedure adapted to control and modulate said thermoregulation system physiological responses such as: vasodilatation, vasoconstriction of blood vessels, shivering or heart rate, by affecting the efferent neurological pathways.
It is another object of the present invention to provide the other system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are configured for predetermined location selected from the group consisting of: topically close to the spinal cord, remote from said spinal cord, transcutaneously, or by means of minimally invasive means to said spinal cord, or any combination thereof.
It is another object of the present invention to provide the other system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are configured to be attached to said body using at least one patch [6].
It is another object of the present invention to provide the other system [1] as defined above, wherein said at least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Electro-Cardio-Graph (ECG) signals.
It is another object of the present invention to provide the other system [1] as defined above, wherein said least one pair of stimulating electrodes [5] are further configured to operate as sensors for measuring Neuro-Electric signals.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to command said stimulation procedure along the whole length of the spinal cord or selected segments thereof, according to required treatment and clinical need.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] is adapted to command and implement said stimulation procedure for controlling said body's temperature and thermoregulation system for the entire body or selected body parts.
It is another object of the present invention to provide the other system [1] as defined above, wherein control panel [20] is adapted to command said stimulation procedure for simultaneously controlling said selected body parts, each for normo-thermia, hyper-thermia or hypo-thermia.
It is another object of the present invention to provide the other system [1] as defined above, wherein said system [1] further comprises means for the application of medication such as: local or general anesthetics, analgesics and or sedation agents, muscle blocking or relaxants agents, pain blocking agents, consciousness impairing agents.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] controls said application of stimulation procedure automatically.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] controls said application of stimulation procedures at least partially manually.
It is another object of the present invention to provide the other system [1] as defined above, wherein said display monitor [30] is configured to display parameters selected from the group consisting of: said measurement units measurements, said control panel [20] optional said stimulating procedures, said control panel [20] said administrated stimulating procedure, or any combination thereof.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20] and said display monitor [30] are combined into a single device, such as a touch screen.
It is another object of the present invention to provide the other system [1] as defined above, wherein said control panel [20], said display monitor [30] and said pulse generator [10] are combined into a single device.
It is another object of the present invention to provide the other system [1] as defined above, wherein said system [1] further comprises at least one Heat Exchange Unit (HEU) [100] for heating or cooling said body.
It is another object of the present invention to provide the other system [1] as defined above, wherein said HEU [100] further comprises: at least one thermal sensor [101], an HEU analysis unit [102], an HEU activating unit [103] and at least one of the following:
It is another object of the present invention to provide the other system [1] as defined above, wherein said heaters [105] or said coolers are placed on a body part selected from the group consisting of: hand palms, feet soles, wrapped around large body parts, or any combination thereof.
It is still an object of the present invention to provide the other system [1] as defined above, wherein said least one pair of stimulating electrodes [5] are configured to be placed parallel to the vertebral column and over the intervertebral foramen, thereby enabling stimulation of the appropriate roots of spinal nerves which supply the affected dermatome.
It is lastly an object of the present invention to provide the other system [1] as defined above, wherein said least one pair of stimulating electrodes [5] layout in relation to the spinal cord vertebrates in a configuration selected from the group consisting of:
In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which
a-10i: present examples regarding the electrodes layout in relation to the spinal cord vertebrate.
The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a system and method for neuromodulation of body temperature regulation system.
In particular, the present invention relates to a system and method for neuromodulation of the body's temperature regulation system, for controlling, monitoring and attenuating the body's temperature and thermoregulation system and physiological responses, such as vasodilatation, vasoconstriction of blood vessels or shivering.
Current methods only affect the external input to the body's system without directly modulating the main internal “thermostat” system.
According to different embodiments of the present invention, the presented technical solution answers the need for controlling and monitoring the body's temperature and thermoregulation physiological responses, such as but not limited to, vasodilatation or vasoconstriction of blood vessels or shivering, and provides a system [1] and method for neuromodulation of the body temperature regulation system.
Reference is now made to a system [1] for controlling and modulating a mammalian's body temperature and thermoregulation system, comprising:
The pulse generator [10] is selected from the group consisting of:
The MAC unit is at least one unit selected from the group consisting of:
Reference is now made to a method for controlling and modulating a mammalian's body temperature and thermoregulation system, the method comprising steps of
Reference is now made to an alternative system [1] for controlling and modulating a mammalian's body temperature and thermoregulation system, comprising:
The measurement unit is selected from the group consisting of:
As described in details hereinbelow, the present invention provides a system [1] and method that may be used to achieve one or more of the following aims: maintain normo-thermia or sensation of normo-thermia, induce or maintain hypo-thermia or sensation of hypo-thermia, or induce or maintain hyper-thermia or sensation of hypo-thermia.
The physiological body temperature regulation system is a homeostatic system that attempts to maintain core body temperature within a certain limited range. It is a complex and dynamic system comprising a set of physiological responses that serve to increase or decrease core body temperature. It receives signals from sensors located both on the patient skin and also deep inside the body.
In the present invention, electrical or electromagnetic stimulation is used to filter the sensory information, e.g., pain, without wishing to be bound by theory, using “gate control”.
The sensory information travels through three types of fibers, but they all have different sub-classes to them. A, B, and C. A and B fibers are myelinated and C fibers are unmyelinated. A fibers are broken down further by conduction velocity into four main groups: α, β, γ and δ. In general, a chart of these fibers would look like this:
In general, the A class of fibers are related to muscles (extrafusal and intrafusal fibers), Aδ sensory fibers relay touch, pressure, pain, and temperature, B motor fibers are for the autonomic system, while C sensory fibers are also for pain and temperature.
The thermal information, for “heat” or “cold”, travels through the same routes as the sensory information such as C fibers, Aδ fibers. By means of the “gate” principle, stimulation of the Aβ fibers, which has fast conduction, overcome other inputs, namely C fibers Aδ fibers, and thus attenuates the thermal information.
The information travels through the peripheral nerve system via the Aδ and C fibers to the spinal cord into the temperature regulation area in the brain, the hypothalamus. The hypothalamus processes the information and reacts accordingly. A series of temperature regulation mechanisms are activated to compensate for the loss or gain of core body temperature.
It has now been unexpectedly found that temperature signals passing through neural pathways between the periphery and the centrally-located temperature regulation centers, such as in the hypothalamus, may be blocked or modified by the cutaneous application of electrical pulses, similar to those used to block pain signals in Transcutaneous Electrical Nerve Stimulation (TENS) systems and its subset InterFerential currents (IFC) systems. Thus, in one aspect of the invention, a modified TENS system is used to block the temperature signals from reaching the brain. The system [1] isolates the hypothalamus from the information traveled via skin and core temperature sensors.
The electrical stimulation covers all somatic dermatomes, such that all incoming thermal data is subject to filtering. Using this technology enables the blocking or modulating the thermal input from reaching the hypothalamus. Thereby body's temperature management could be performed in a safer manner, more efficient and easier by isolating the body's “thermostat” from reacting to active cooling of the body.
The system [1] of the present invention thereby facilitates efficient temperature manipulation of either the entire body or regions thereof for in routine clinical setting, with or without general anesthesia.
In humans, as represented in
The present invention primary provides a system [1] and method for controlling and modulating the body's temperature in a mammalian, preferably human subject, by means of applying electrical or electromagnetic stimulation in proximity to peripheral nerves that play a role in the thermoregulation system. Electrical stimulation can be generated by electrical pulses and electromagnetic stimulation for example by placing solenoids (
The method of the present invention comprises applying electrical or electromagnetic stimuli, variable in: intensity, frequency, amplitude, waveform, wave length, pulse intervals length and phase, such as bi-phasic either in proximity to the body, topically, over the skin; either close to the spinal cord or remote therefrom, transcutaneously or by minimally invasive means to the spinal cord via electrode pads [5]. The electrical pulses, variable in signal intensity, frequency, amplitude, waveform, wavelength, pulse interval length and phase, manipulate the temperature signals that travel from the entire body or selected body parts to and from the brain to isolate the thermoregulation system from reacting to changes in skin or core temperature.
The method of the present invention may be used in a number of different ways in order to achieve the desired thermoregulatory effect. These various different modes of operation (as will be described in the following section) may be grouped into the following three general classes of method:
The present invention includes within its' scope many different variants of these basic approaches. Some of these are listed below:
Stimulating Aβ Fibers:
Stimulating the fast conduction fibers Aβ to modulate the thermal input transferred to the hypothalamus.
Stimulating Aβ Fibers+C Fibers (“Heat” Simulation):
Stimulating the last conduction fibers Aβ and the slow conduction C fibers for “heat” input to modulate the thermal input received by the hypothalamus.
Stimulating Aβ Fibers+C Fibers (“Heat” Simulation)+Aδ (“Cold” Input Blockage):
Stimulating the fast conduction fibers Aβ, the slow conduction C fibers for “heat” input and blocking the medium conduction Aδ fibers input to modulate the thermal input received by the hypothalamus.
Stimulating Aβ Fibers+Aδ (“Cold” Stimulation):
Stimulating the fast conduction fibers Aβ and the medium conduction Aδ fibers for “cold” input to modulate the thermal input received by the hypothalamus.
Stimulating Aβ Fibers+Aδ (“Cold” Stimulation)+C Fibers (“Heat” Input Blockage):
Stimulating the fast conduction fibers Aβ, the medium conduction Aδ fibers to “cold” input and blocking slow conduction C fibers input to modulate the thermal input received by the hypothalamus.
Stimulating or Blockage of C Fibers Only:
Stimulate to modulate slow conduction C fibers input to modulate the thermal input received by the hypothalamus.
Stimulating or Blockage of Aδ Fibers Only:
Stimulate to modulate medium conduction Aδ fibers input to modulate the thermal input received by the hypothalamus.
Stimulating or Blockage of Motor Neurons:
Stimulate to modulate motor neurons activity due to input received from the hypothalamus related to changes in body temperature.
Partial Body Coverage (“Cold” Areas and/or “Hot” Areas Simultaneously):
Stimulating the nerve fibers to simulate “cold” or “heat” input from different parts of the body.
Thus, in one embodiment, the method comprises the application of a variety of electrical pulses, variable in signal intensity, magnitude and phase that simulate thermal information (“heat” or “cold”) from the entire body or selected body parts to manipulate the body thermoregulation system.
Without wishing to be bound by theory, the body reacts to the stimulating pulses as if it was cooled or heated without the actual application of “heat” or “cold”.
The method optionally comprises applying a variety of electrical pulses and intensities directly to the C fibers or Aδ fibers to manipulate or block sensory information passage through these roots.
In a further embodiment, the method comprises applying a variety of electrical or electromagnetic stimuli variable in: intensity, frequency, amplitude, waveform, wave length, pulse intervals length and phase, such as bi-phasic, wherein the stimuli is used to block afferent thermoregulatory signals that have their origin in the periphery and would otherwise travel to the hypothalamic temperature regulation centers.
In this embodiment, the system [1] can block information from traveling on C fibers and Aδ fibers by stimulating these nerves by pulses to maintain constant refractory period and avoiding new action potential to be generated. The system [1] stimulates the Aβ fibers to control passage of sensory information traveling to the brain. The current delivered to each pair of electrodes [5] can be optimized according to the degree of current travelling through the body to the next pair.
In another aspect, the method of the invention comprises applying a variety of electrical pulses, variable in signal intensity, magnitude and phase to the efferent motor neurons receiving input from the thermoregulation system to manipulate or block vasodilatation or vasoconstriction of blood vessels or shivering.
The stimulating procedures of electric pulses are regulated by means of current's amplitude [A], frequency spectrum [F] and phase [φ], applied to selected electrode pairs [5], where signals are variable in: intensity, frequency amplitude, waveform, wave length, pulse intervals length and phase, such as bi-phasic.
In reference to the system [1] of the present invention, in one embodiment, the system [1] comprises a multitude of electrode pair pads [5] connected to a pulse generator [10] for electrical stimulation, as shown in
An example of suitable off-the-shelf Pulse Generator is the ANALGESIC PULSER EMS PROFESSIONAL DIGITAL DELUXE EMS MACHINE, Model: AP-439, supplied by BUYAMAG INC. CA, USA. An example of suitable off-the-shelf electrodes are the DURA-STICK® II Self-adhesive Electrodes 2″ Square (40) (Model: 42041) manufactured by the Chattanooga Group, Hixson Tenn., USA.
The system [1] further comprises a control panel [20] and a display monitor [30], both connected to the pulse generator [10].
The pulse generator [10] generates electrical pulses variable in signal intensity, magnitude and phase, according to the particular clinical needs i.e. partial or entire body cooling or heating. In one preferred embodiment, the system [1] comprises a set of 31 pairs of percutaneous electrodes [5] attached by stickers onto the dorsal skin of the patient on both sides of the spinal cord. The stimulation can be applied along the whole length of the spinal cord or applied only selected segments (selected number of electrode pairs [5]) thereof, depending on the required treatment and clinical need.
The type of pulse generated (intensity, magnitude, phase and waveform) is optionally controlled by the operator via operator-generated input through control panel [20]. In this way, the desired pulse characteristics required in order to block the body thermal information from reaching the brain, or to block the efferent passage thermal information from the brain along neuromotor pathways, may be determined and controlled.
According to a preferred embodiment of the present invention, the system [1] comprises at least one Measurement Analysis and Command (MAC) unit that receive various types of physiological signals from the body, as shown in
The system [1], according to this preferred embodiment, comprises one or more of the following Measurement Analysis and Command (MAC) units:
A. The Heart Rate Variability (HRV) unit [50], shown in
An example of a suitable off-the-shelf measuring device is the model—Heart Rhythm Scanner 2.0, manufactured by Biocom Technologies, Poulsbo Wash., USA, or the model PageWriter TC50 cardiograph, manufactured by Koninklijke Philips Electronics N.V.
In one preferred embodiment, the receiving unit [51] receives electrocardiogram signals from a separate set of electro cardio graph sensors or from the present invention system [1] electrode pads [5] that not only function as electric pulse stimulators but also additionally function as Electro-Cardio-Graph sensors that measure and transfer the electrocardiogram data signals from the body to the HRV receiving unit [51].
The data is then transferred to the HRV analysis unit [52]. The HRV analysis unit [52] analyses, according to a dedicated application, the received signals that indicate parasympathetic activity in the body. The signals are analyzed in time and frequency domains. The HRV analysis unit [52] determines whether a change in the parasympathetic activity in the body requires activating the pulse generator [10] due to a change (or an expected change) in the patient's body temperature (thus requiring the stimulating pulses) or whether the parasympathetic activity in the body is “normal” and thus there is no need to activate pulse generator [10]. The HRV analysis unit [52] also determines the optimal blocking pulse to be generated i.e. optimal intensity, optimal magnitude and optimal phase. This is determined according to the electrocardiogram data received from the sensors.
If the parasympathetic activity in the body is “normal” the analysis unit [52] transfers a signal to the “output to Pulse Generator” unit [59] indicating that the system [1] should stay as is, i.e. the pulse generator [10] should be activated in its default state.
If the parasympathetic activity in the body requires activating the pulse generator [10] then an activating signal is transferred to the activating unit [53]. The activating unit [53] then sends a signal to the “output to Pulse Generator” unit [59] indicating an activation request including the optimal blocking pulse characteristics. The data from the “output to Pulse Generator” unit [59] is transferred out of the HRV unit [50] and into the pulse generator [10].
B. The Electromyography (E.M.G.) unit [60], shown in
An example of a suitable off-the-shelf measuring device is the model—Neuropack M1 manufactured by NIHON KOHDEN CORPORATION, JAPAN.
The data signals are then transferred to the EMU analysis unit [62]. The EMG analysis unit [62] analyses, according to a dedicated application, the received signals that indicate the EMG activity in the body. The EMG analysis unit [62] determines whether the EMG activity in the body is representative of shivering or muscle movement, thus requiring activation of the pulse generator [10] due to a change, or an expected change, in the patient's body temperature and thus requiring the blocking pulses or whether the EMG activity in the body is “normal”, when shivering does not occur, and thus there is no need to change the pulse generator [10] activity.
If shivering does not occur, EMG analysis unit [62] transfers a signal to the “output to pulse generator” unit [69] indicating that the system [1] should stay as is, i.e. the pulse generator [10] should be activated in its default state.
If shivering occurs, then the EMG data is transferred to the dermatome identification unit [65]. The dermatome identification unit [65] analyzes the EMG data received by means of a dedicated application, and determines which dermatomes are affected by the EMG muscle movement (i.e. shivering) data. Then the identification unit [65] also determines, by means of a dedicated application, the optimal blocking pulse to be generated i.e. optimal intensity, optimal magnitude and optimal phase. Identification unit [65] also determines to which electrodes [5], placed on which dermatome, the pulses should be generated hereinafter referred to as the target electrodes [5]. This is determined according to the electro-cardio-gram data received from the sensors, by means of a dedicated application.
The information concerning the optimal blocking pulses and the target electrodes [5] is transferred to the activating unit [63]. The activating unit [63] then sends a signal to the “output to pulse generator” unit [69] indicating an activation request including the optimal blocking pulses and the target electrodes [5]. The data from the “output to Pulse Generator” unit [69] is transferred out of the E.M.G. unit [60] and into the pulse generator [10].
C. The temperature measuring T(skin and/or core) unit [70], shown in
The temperature measuring T(skin and/or core) unit [70] further comprises a receiving unit [71s] that receives the body's skin or core temperature data from a second off-the-shelf thermal measuring device. The skin or core temperature data received from the thermal measuring device is measured by means of thermal sensors placed on certain locations on the body skin as determined by the operator.
The data from [71c] and [71s] is then transferred to the T(skin and/or core) analysis unit [72]. The analysis unit [72] analyses, according to a dedicated application, the received temperature data. If the body temperature changes in a rate faster or slower than a predetermined set point rate, then T(skin and/or core) analysis unit [72] will choose to activate the pulse generator [10]. The set point rate is determined and set by the operator via control panel [20] also connected to T(skin and/or core) analysis unit [72] (not shown).
For example, If the body core heat rises at an average rate slower than 0.1° C. every 3 minutes (2° C. an hour), then the pulse generator [10] will be activated to cool the body. The T(skin and/or core) analysis unit [72] also determines the optimal blocking pulse to be generated i.e. optimal intensity, optimal magnitude and optimal phase. This is determined according to the temperature data received from the thermal measuring devices. This determination is achieved by means of a dedicated application.
If the temperature changing rate is faster than the pre set rate T(skin and/or core) analysis unit [72] transfers a signal to the “output to Pulse Generator” unit [79] indicating that the system [1] should stay as is i.e. the pulse generator [10] should not change its activity.
D. The breathing measuring [Vo2] unit [80], shown in
An example of a suitable off-the-shelf measuring device is the model—ECG-VO2—the CPX-system, manufactured by Cortex Biophysik GmbH, Germany.
The data is then transferred to the Vo2 analysis unit [82]. The Vo2 analysis unit [82] analyses, according to a dedicated application, the received signals that indicate the breathing oxygen rate of the body. The Vo2 analysis unit [82] determines whether the breathing activity in the body requires activating the pulse generator [10] due to a change, or an expected change, in the patient's body temperature, thus requiring the blocking pulses, or whether the breathing activity in the body is “normal” and thus there is no need to activate pulse generator [10].
For example, if the body breathing oxygen rate rises above 25% than a predetermined rate, then the pulse generator [10] will be activated. The Vo2 analysis unit [82] also determines the optimal blocking pulse to be generated i.e. optimal intensity, optimal magnitude and optimal phase. This is determined according to the breathing rate data received by the breathing rate device. This determination is achieved by means of a dedicated application.
If the breathing activity in the body is “normal” the analysis unit [82] transfers a signal to the “output to pulse generator” unit [89] indicating that the system [1] should stay as is i.e. the pulse generator [10] should not change its activity.
If the breathing activity in the body requires activating the pulse generator [10] then an activating signal is transferred to the activating unit [83] including the optimal blocking pulse. The activating unit [83] then sends a signal to the “output to Pulse Generator” unit [89] indicating an activation request including the optimal blocking pulse characteristics. The data from the “output to pulse generator” unit [89] is transferred out of the Vo2 unit [80] and into the pulse generator [10].
E. The neuro-signal unit [90], shown in
The data signals are then transferred to the Neuro-signal analysis unit [92]. The Neuro-signal analysis unit [92] analyses, according to a dedicated application, the received signals that indicate the neuro-electric activity in the body. The neuro Signal analysis unit [92] determines whether the neuro-electric activity in the body requires activating the pulse generator [10] due to a change, or an expected change, in the patient's body temperature and thus requiring the blocking pulses, or whether the neuro electric activity in the body is “normal” and thus there is no need to activate pulse generator [10].
If the neuro-electric activity in the body is “normal”, i.e., according to the set point, neuro-signal analysis unit [92] transfers a signal to the “output to pulse generator” unit [99] indicating that the system [1] should stay as is.
If the neuro-electric activity is not “normal”, then the neuro-electric data is transferred to the dermatome identification unit [95]. The dermatome identification unit [95] analyzes the neuro-electric data received by means of a dedicated application, and determines which dermatomes are affected by the neuro-electric data. Dermatome identification unit [95] also determines to which electrodes [5], placed on which dermatome, the pulses should be generated hereinafter referred to as the target electrodes [5]. This is determined according to the neuro-electric data received from the sensors, by means of a dedicated application.
The Neuro signal unit [92] also determines, by means of a dedicated application, the optimal blocking (opposite signal) pulse to be generated, i.e. optimal intensity, optimal magnitude and optimal phase, according to the received input signals.
Optionally, the operator can choose, via control panel [20] further connected to neuro-signal unit [90], the heat or cold characteristics of the desired pulse, i.e. whether to send “heat” or “cool” signals to the hypothalamus.
It is also optional for the operator to choose, via control panel [20], the appropriate dermatome instead of the dermatome identification unit [95].
The information concerning:
The pulse generator [10] receives the activation information, the optimal signals and the target electrodes [5], in the case of units [90] and [60], from the input units, and generates electric pulses accordingly.
The system [1] can also function using only one of the input units. The system [1] can also function without any of the input units by means of the operator inputting the desired pulse generating characteristics via control panel [20].
It should be understood that according to an embodiment of the present invention two or more of the system [1] input units could be applied and activated simultaneously.
If two or more of the input units are activated simultaneously, then the blocking pulses will be generated by the pulse generator [10] consequent upon the first input unit that requires a change in the generation of pulses according to the first input unit-output characteristics.
The system [1] can function automatically i.e. the electric pulses are generated by the pulse generator [10] automatically according to the output data of the input units.
The system [1] can also function be operated manually via a system [1] operator that receives all the data from the activated input units and views all the data on monitor [30]. The system [1] operator can determine according to the data viewed what type of pulses should be generated and generate them using control panel [20].
The electrodes are placed in a manner according to the system [1] operator's decisions not limited to the layout manners shown in the figures herein, which serve only as examples.
In one embodiment of the present invention the system [1] further comprises a Heat Exchange Unit (HEU) [100], shown in
The HEU analysis unit [102] analyses, according to a dedicated application, the received signals that indicate the temperature of the body.
If the body temperature is “normal” the analysis unit [102] transfers a signal to the “output to heaters” unit [109] indicating that the heaters [105] should stay off.
If the body temperature exceeds a predetermined temperature, determined by the operator via control panel [20], then an activating signal is transferred to the activating unit [103]. The activating unit [103] then sends a signal to the “output to heaters” unit [109] indicating an activation request. The data from the “output to heaters” unit [109] is transferred out of the HEU [100] turning ON the heaters [105].
If further temperature signals are received indicating of the cooling of the body below the preset temperature, then a signal is sent to the activating unit [103] which sends a signal to the “output to heaters” unit [109] indicating a “stop activation” request, which is transferred to heaters [105] turning them off.
According to an embodiment of the present invention the HEU [100] can function only when appropriate signals are received from sensors [101] or it can also function automatically when the pulse generator [10] begins to generate blocking pulses, in which case an activating signal is transferred from the pulse generator [10] to HEU [100].
The heaters [105] are preferably placed on the hand palms and feet soles. As known in the art, these areas have the highest rate of sensors to skin surface, so heating these areas of the body is the most efficient. It should be noted that a similar HEU cooling unit can also be applied for cooling options in addition to the heaters, in a similar manner as described hereinabove.
Various different type of heat exchange module may be used in this embodiment of the system [1] of the present invention, including but not limited to, those based on Peltier-effect thermoelectric heat exchanger technology, computerized heating/cooling elements, elements wrapped around large body parts, as well as other suitable devices.
Examples for stimulating procedures and the stimulation regimes include:
The range of currents (A, B) frequencies range is from about 0 to about 30,000 Hz
The beat frequency, i.e. the difference between the frequencies (A, B), range between about 0 to about 1000 Hz.
The change in frequency over time can be linear, nonlinear, sinusoidal, or any combination thereof.
The simulating procedure intervals may range from about 0 to about 300 [sec].
The present invention technology includes:
The advantages of the present invention include, but not limited to:
It will be appreciated by a person skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and sub-combinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL2012/000235 | 6/14/2012 | WO | 00 | 5/8/2014 |
| Number | Date | Country | |
|---|---|---|---|
| 61496588 | Jun 2011 | US |
