US20040133249A1 - Adaptive stimulator for relief of symptoms of neurological disorders - Google Patents

Abstract

Methods and systems of cueing an individual to facilitate restoration of impaired voluntary movement is provided. The method includes receiving one or more input signals based on human body functions from at least one sensor. When the one or more input signals meet a defined criteria, indicating impaired voluntary movement, generating one or more sensory cues, wherein the one or more sensory cues include tactile cues, aural cues, and visual cues. The method further includes selectively transmitting stimulation signals to produce the one or more sensory cues and selectively adjusting the one or more sensory cues when the impaired voluntary movement is not broken.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a divisional of U.S. application Ser. No. 09/659,351, (the '351 application) filed Sep. 12, 2000, entitled “ADAPATIVE STIMULATOR FOR RELIEF SYMPTOMS OF NEUROLOGICAL DISORDERS”, which, in turn, is related to and claims the benefit of the filing date of provisional application Serial No. 60/204,404 (the '404 application), filed on May 16, 2000. The '351 and '404 applications are incorporated by reference.[0001]
TECHNICAL FIELD
• The present invention relates generally to the field of electronics and, in particular, to the relief of Parkinson's disease symptoms using electrical stimulation.[0002]
BACKGROUND
• Parkinson's disease is a neurodegenerative disorder that affects approximately one percent of the population over age[0003]50 and up to two and a half percent of the population over age70. The disease is currently of unknown origin, but appears to be the result a deficiency in dopamine (a neurotransmitter) due to the degeneration of an area of the brain known as the substantia nigra pars compacta.
• Currently there is no diagnostic test for Parkinson's disease and diagnosis is based on the presence of characteristic symptoms and elimination of other potential causes through magnetic resonance imaging (MRI). At this time there is no cure for Parkinson's disease, only treatment to relieve the symptoms. The cardinal symptoms of Parkinson's disease are paucity of spontaneous movements, slowness of movement, rigidity of muscle tone, and the characteristic tremor at rest. In addition, there is often a mask-like facial expression and flexed posture. Treatment with medication to relieve the symptoms of Parkinson's disease is typically effective in the early stages of the disease's progression. However, the medication's effectiveness is highly variable from patient to patient. Medications also have undesirable side effects that get worse with increased dosage. As the disease progresses, it becomes more difficult to meter the medication to bring symptomatic relief while minimizing side effects. For example, some patients may be able to manage symptoms effectively with medication for 25 years. While other patients may experience intolerable side effects from increased dosage of medication within 5 years. The rate of disease progression is also highly variable.[0004]
• When medication can no longer effectively manage symptoms, the patient has limited options. These include brain surgeries that lesion specific overactive areas in the brain and implanted electrodes in overactive brain areas that are controlled by a pacemaker-like device for stimulation. The stimulation appears to dampen the firing of overactive neurons providing similar symptomatic relief to the lesions. These surgical procedures are high-risk with the potential for causing hemorrhaging, blindness, or stroke.[0005]
• Loss of sensing function is the major contributor to manifestation of symptoms associated with Parkinson's disease. The loss of sensing function or inability to process sensing information leads to problems with joint position sense (observation). This in turn leads to instability in the control loops of the Basil Ganglia, causing oscillation (tremor), out of phase control signals (rigidity), and the inability to initiate a relative motor plan (akinesia) and slowed movement execution (bradykinesia). The instability results in the presentation of symptoms where a patient is unaware of a bent arm, drooping head, stooped posture, slowed gait, or lack of arm swing. As a result there is a need in the art to provide relief to patients affected with Parkinson's disease.[0006]
• For the reasons stated above, and for other reasons stated below which will become apparent to those skilled in the art upon reading and understanding the present specification, there is a need in the art for improvements in techniques to provide patients affected with Parkinson's disease relief from the symptoms.[0007]
SUMMARY
• The above mentioned problems with treatment of the symptoms of Parkinson's disease and other problems are addressed by embodiments of the present invention and will be understood by reading and studying the following specification.[0008]
• In one embodiment, an adaptive stimulator is provided. The stimulator includes a control unit and at least one stimulation electrode coupled to an output of the control unit. The at least one stimulation electrode is adapted to provide stimulation to an area of the body of a living subject. The adaptive stimulator includes at least one sensor coupled to the control unit and adapted to be disposed external to the human body. The sensor is adapted to respond to physical stimulus and provide input to the control unit. The adaptive stimulator is adapted to selectively provide stimulation in response to the control unit.[0009]
• In another embodiment, a method of adaptive stimulation is provided. The method includes receiving one or more input signals. At least one of the input signals is based on physical stimulus. The method also includes monitoring the received input signals and selectively generating one or more stimulation signals when the one or more input signals meet defined criteria. The method further includes transmitting the one or more stimulation signals to an area of the body of a living subject. The one or more stimulation signals aid in the relief of symptoms of neurological disorders.[0010]
• In another embodiment, a control unit adapted to aid in the relief of symptoms of Parkinson's disease is provided. The control unit includes an input that is adapted to couple to one or more sensors that are adapted to respond to physical stimulus. The control unit also includes a controller that is coupled to the input and a waveform generator coupled to the controller. The control unit further includes an output coupled to the controller and adapted to couple to one or more stimulation electrodes that are adapted to provide stimulation to an area on the human body. In addition, the control unit includes a stimulation voltage pulse generator coupled to the controller.[0011]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a block diagram of an embodiment of an adaptive stimulator constructed according to the teachings of the present invention.[0012]
• FIG. 2 is an illustration of a cylindrical view of one embodiment of a cylindrical stimulation electrode constructed according to the teachings of the present invention.[0013]
• FIG. 3 is an illustration of an inside plane view of one embodiment of a cylindrical stimulation electrode constructed according to the teachings of the present invention.[0014]
• FIG. 4 is an illustration of a cylindrical view of one embodiment of a cylindrical tactile sensor constructed according to the teachings of the present invention.[0015]
• FIG. 5 is an illustration of an inside plane view of one embodiment of a cylindrical tactile sensor shown constructed according to the teachings of the present invention.[0016]
• FIG. 6 is an illustration of one embodiment of an assembly for a cylindrical tactile sensor and a cylindrical stimulation electrode insert cylindrical tactile sensor constructed according to the teachings of the present invention.[0017]
• FIG. 7 is an illustration of a palm view of one embodiment of a tactile sensor and stimulation glove constructed according to the teachings of the present invention.[0018]
• FIG. 8 is an illustration of a top view of one embodiment of a tactile sensor and stimulation glove constructed according to the teachings of the present invention.[0019]
• FIG. 9 is an illustration of a top view of one embodiment of a tactile sensor and stimulation glove integrated with finger sensors constructed according to the teachings of the present invention.[0020]
• FIG. 10 is an illustration of one embodiment of a stimulation and sensing wristband constructed according to the teachings of the present invention.[0021]
• FIG. 11 is an illustration of one embodiment of a shoe insert constructed according to the teachings of the present invention.[0022]
• FIG. 12 is an illustration of one embodiment of a sock insert constructed according to the teachings of the present invention.[0023]
• FIG. 13 is an illustration of one embodiment of a stimulation and sensing ankle band constructed according to the teachings of the present invention.[0024]
• FIG. 14 is an illustration of one embodiment of a stimulation and sensing headband constructed according to the teachings of the present invention.[0025]
• FIG. 15 is an illustration of one embodiment of a stimulation neckband constructed according to the teachings of the present invention.[0026]
• FIG. 16 is a flow diagram of one embodiment of method of adaptive stimulation for the treatment of the symptoms of Parkinson's disease according to the teachings of the present invention.[0027]
• FIG. 17 is a schematic of one embodiment of an adaptive stimulator according to the teachings of the present invention.[0028]
DETAILED DESCRIPTION
• In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific illustrative embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that logical, mechanical and electrical changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.[0029]
• FIG. 1 is a block diagram of one embodiment of an adaptive stimulator, shown generally at[0030]100, constructed according to the teachings of the present invention.Adaptive stimulator100 includes acontrol unit120 coupled to at least onesensor110. The at least onesensor110 is responsive to physical stimulus such as pressure, acceleration, inclination or the like. In addition,adaptive stimulator100 includes one ormore stimulation electrodes130 coupled to an output ofcontrol unit120. Eachstimulation electrode130 or more than oneelectrodes130 include a common return electrode. The common return electrode is in direct contact with the skin and provides the return path for each of the electrical stimulation electrodes attached to the body. It provides a large surface and as a result a lower impedance than each of the stimulation electrodes, this will aid in keeping the current at the contact location at a comfortable level for the patient. Eachsensor110 is strategically located to receive information based on human body functions such as tactility (pressure), movement (acceleration), placement (inclination) and the like. Eachsensor110 provides information to controlunit120.Control unit120 receives the information and uses the information to determine when electrical stimulation is required at the location of eachstimulation electrode130.Control unit120 selectively adjusts stimulation voltage, frequency, pulse width, waveform shape, amplitude, modulation type and the like of each electrical stimulation signal based on sensor information. Modulation type allows selection of one of a collection of dynamic waveform changes that vary amplitude, frequency or pulse width in some predetermined manner. In some applications, the body adapts to static waveforms decreasing sensitivity and this modulation feature prolongs stimulation effectiveness.
• In one embodiment,[0031]adaptive stimulator100 includes adisplay132 coupled to controlunit120. In another embodiment,adaptive stimulator100 includes acontrol panel133 coupled to controlunit120. In an alternate embodiment,adaptive stimulator100 includes an integrated display andcontrol panel123 coupled to controlunit120.Control panel133 andintegrated control panel123 provide an operator interface for modification of operation ofadaptive stimulator100. In an embodiment, having a stand-alone control panel133 orintegrated control panel123,control unit120 selectively adjusts stimulation voltage, frequency, pulse width, waveform shape, amplitude, modulation type and the like based on sensor information and operator controls.
• In one embodiment,[0032]control unit120 includes acontroller122 that receives information fromsensors110.Controller122 includes software that includes algorithms for processing the information from input signals and determines the response(s) required to produce simulation and stimulation. Thecontroller122 generates the basic timing for the stimulation waveforms and adjusts frequency, pulse width, waveform shape, and amplitude based on sensor information or sensor information and operator controls.
• In one embodiment,[0033]control unit120 includes a stimulationvoltage pulse generator121 coupled to an output ofcontroller122. Stimulationvoltage pulse generator121 produces individual stimulation signals for eachstimulation electrode130. In one embodiment, stimulation signals are phased, as non-overlapping pulses, to prevent unwanted cross coupling of currents betweenstimulation electrodes130.Control unit120 further includes awaveform generator126 coupled betweencontroller122 and stimulationvoltage pulse generator121.Waveform generator126 receives input fromcontroller122 and generates waveforms for input to stimulationvoltage pulse generator121. In addition,control unit120 includes an over voltage/current monitoring circuit128 coupled between stimulationvoltage pulse generator121 andcontroller128.Monitoring circuit128 monitors stimulation electrode voltage and current and provides information tocontroller122 to prevent exposure of the patient to uncomfortable stimulation levels. In one embodiment,control unit120 includes anamplitude control device124 coupled betweencontroller122 and stimulationvoltage pulse generator121.
• In one embodiment,[0034]adaptive stimulator100 includes atelemetry link101. Data is transmitted fromcontrol unit120 to aremote processing unit109 for further collection and processing of data obtained. In one embodiment,control unit120 retains information about the operation of theadaptive stimulator100 to include inputs to and outputs fromcontrol unit120. In one embodiment, the information is used to track the progress of the disease and to monitor the operation ofadaptive stimulator100. In one embodiment, the information collected includes sensor and stimulator information. In another embodiment, the information further includes patient information and other data input to the control unit viacontrol panel133 and/orremote processing unit109. In one embodiment, the information is stored in a database, a memory device or the like that is included incontrol unit120. In one embodiment, the information is transmitted toremote processing unit109 and stored byremote processing unit109. In another embodiment, the information is wirelessly transmitted toremote processing unit109. In one embodiment, the information is stored remotely byremote processing unit109 for processing by any one ofcontrol unit120,remote processing unit109 or another device directly coupled to controlunit120 or coupled to controlunit120 viaremote processing unit109.
• In one embodiment,[0035]adaptive stimulator100 includes one or moreaural stimulators177. In one embodiment, theaural stimulator177 includes a headphone and is driven bycontroller122. In one embodiment, the headphones provide aural cues for drooping or tilted head and cadence for walking and repetitive activities.
• In one embodiment,[0036]sensor110 includes a pressure sensor located on an external region of the body.Control unit120 interrogates the pressure sensor and receives pressure data. Thecontrol unit120 determines if the pressure data meets a certain threshold or criteria. When the pressure data meets or exceeds the determined threshold, thecontrol unit120 generates stimulation signals and transmits the signals tostimulation electrodes130. In one embodiment, the stimulation electrodes are located so as to provide a cue to the finger.
• FIG. 2 is an illustration of a cylindrical view of one embodiment of a cylindrical stimulation electrode, shown generally at[0037]200, constructed according to the teachings of the present invention.Stimulation electrode200 includes aflexible conductor235 that aids in fitting theelectrode200 around fingers, thumbs, wrist, ankle and other cylindrically shaped regions of the body.Conductor235 is coupled to anelectrical lead241 that is coupled to and receives electrical pulses from a control unit such ascontrol unit120 described with respect to FIG. 1. The electrical pulses are utilized for cutaneous stimulation of a region of the body by transmission of the electrical pulses to a conductiveskin contact area239 viaconductor235. In one embodiment,conductor235 is integral to conductiveskin contact area239, which is located on the inside ofcylindrical electrode200.
• In one embodiment, conductive[0038]skin contact area239 comprises conductive electrolytes for electrically couplingcylindrical electrode200 to the skin in the form of fluids, gels, a flexible conductive fabric or material or the like. In one embodiment, conductiveskin contact area239 comprises a conductive adhesive gel for electrically couplingcylindrical electrode200 to the skin. This conductive gel is adhesive in nature so that it may perform a dual function by both electrically coupling the electrode to the body and adhering the electrode to the body. In one embodiment, the conductive adhesive gel is disposed as a separate adhesive electrically conductive pad that is coupleable tostimulation electrode200. Thus, only an expendable gel pad material need be disposable. In another embodiment,cylindrical stimulation electrode200 is disposable.
• [0039]Stimulation electrode200 further includes a non-conductiveskin contact area237 located on the inside ofcylindrical electrode200. In one embodiment,stimulation electrode200 includes an electricallyinsulative material231 on the exterior of the cylindrical stimulation electrode. In one embodiment, the electricallyinsulative material231 has elastic properties such that thecylindrical stimulation electrode200 can be adjusted to fit many different sized fingers, ankles, wrists or the like. In another embodiment,stimulation electrode200 includes aseam269 that has elastic properties that allows thecylindrical stimulation electrode200 to be adjusted to fit many different sized fingers, ankles, wrists or the like. In another embodiment,cylindrical electrode200 adjusts to fit a variety of different sized body parts for example one size that fits a variety of upper arms, forearms, wrists, torsos, ankles, knees, calves, thighs or the like.
• FIG. 3 is an illustration of an inside plane view of one embodiment of a cylindrical stimulation electrode, shown generally at[0040]300, constructed according to the teachings of the present invention.Stimulation electrode300 includes aconductor335 coupled to anelectrical lead341.Electrical lead341 is coupled to and receives electrical pulses form a control unit such ascontrol unit120 described with respect to FIG. 1. The electrical pulses are utilized for cutaneous stimulation of a region of the body by transmission of the electrical pulses to a conductiveskin contact area339 viaconductor335. In one embodiment,conductor335 is integral to conductiveskin contact area339.
• In one embodiment, conductive[0041]skin contact area339 comprises conductive electrolytes for electricallycoupling stimulation electrode300 to the skin in the form of fluids, gels, a flexible conductive fabric or material or the like. In one embodiment, conductiveskin contact area339 comprises a conductive adhesive gel for electricallycoupling stimulation electrode300 to the skin. In one embodiment, the conductive adhesive gel is disposed as a separate adhesive electrically conductive pad that is coupleable tostimulation electrode300. The adhesive pad is disposable and replaced after each use. In another embodiment, stimulation electrode is disposed when wear dictates replacement.
• [0042]Stimulation electrode300 further includes a non-conductiveskin contact area337 coupled to either side ofconductive area339. In one embodiment,stimulation electrode300 includes aseam369 made of a material that has elastic properties such that thestimulation electrode300 can be adjusted to fit different sizes of similar body parts. In one embodiment,cylindrical stimulation electrode300 adjusts to fit a variety of different sized fingers. In another embodiment,cylindrical electrode300 adjusts to fit a variety of different sized body parts for example one size that fits a variety of upper arms, forearms, wrists, torsos, ankles, knees, calves, thighs or the like.
• FIG. 4 is an illustration of a cylindrical view of one embodiment of a cylindrical tactile sensor, shown generally at[0043]400, constructed according to the teachings of the present invention.Tactile sensor400 includes apressure sensor408 that is integral to thebody405 of thetactile sensor400. Thepressure sensor408 is coupled to a firstelectrical lead496 and a secondelectrical lead497. The first and secondelectrical leads496 and497 are coupled to a control unit such ascontrol unit120 discussed with respect to FIG. 1. In one embodiment, thefirst lead496 receives a request for information from the control unit and thesecond lead497 provides a response signal to the control unit containing pressure information. In another embodiment, thefirst lead496 andsecond lead497 each provide pressure information to the control unit for a determination as to whether stimulation should be provided. In one embodiment, thebody405 oftactile sensor400 is fabricated of a material that has elastic properties such that thetactile sensor400 can be adjusted to fit many different sized fingers, ankles, wrists or the like. In another embodiment, thebody405 oftactile sensor400 includes aseam467 that is fabricated of a material that has elastic properties such that thetactile sensor400 can be adjusted to fit many different sized body parts. In one embodiment, cylindricaltactile sensor400 adjusts to fit a variety of different sized fingers. In another embodiment, cylindricaltactile sensor400 adjusts to fit a variety of different sized body parts for example one size that fits a variety of upper arms, forearms, wrists, torsos, ankles, knees, calves, thighs or the like. In one embodiment,tactile sensor400 includes apad406 coupled topressure sensor408.Pad406 is made of a material, such as rubber, neoprene or the like, which aids in gripping. In an embodiment, wherepressure sensor400 fits on a finger tip, thepad406 is adapted to aid in contacting buttons, switches, and the like.
• FIG. 5 is an illustration of an inside plane view of one embodiment of a cylindrical tactile sensor, shown generally at[0044]500, constructed according to the teachings of the present invention.Tactile sensor500 includes apressure sensor508 that is integral to thebody505 oftactile sensor500.Pressure sensor508 is coupled to a first and a secondelectrical lead596 and597 respectively. The first and secondelectrical leads596 and597 are coupled to a control unit such ascontrol unit120 discussed with respect to FIG. 1. In tone embodiment, thefirst lead596 receives a request for information from the control unit and thesecond lead597 provides a response signal to the control unit containing pressure information. In another embodiment, thefirst lead596 andsecond lead597 each provide pressure information to the control unit for a determination as to whether stimulation should be provided. In one embodiment, thebody505 oftactile sensor500 is fabricated of a material that has elastic properties such thattactile sensor500 can be adjusted to fit many different sized body parts. In another embodiment, thebody505 oftactile sensor500 includes aseam567 that is fabricated of a material that has elastic properties. In one embodiment, cylindricaltactile sensor500 adjusts to fit a variety of different sized fingers. In another embodiment, cylindricaltactile sensor500 adjusts to fit a variety of different sized body parts for example one size that fits a variety of upper arms, forearms, wrists, torsos, ankles, knees, calves, thighs or the like. In one embodiment,tactile sensor500 includes apad506 coupled topressure sensor508.Pad506 is made of a material, such as rubber, neoprene or the like, which aids in gripping. In an embodiment, wherepressure sensor500 fits on a finger tip, thepad506 will aid in contact with buttons, switches, and the like.
• In one embodiment, a cylindrical tactile sensor such as[0045]400 or500 fits together with a stimulation electrode such as200 or300 to create an assembly used to monitor pressure at a location on the body and provide electrical stimulation to that area. In one embodiment,tactile sensor400 or500 fits overstimulation electrode200 or300 to form a single integrated assembly. FIG. 6 is an illustration of one embodiment of anassembly600 for a cylindricaltactile sensor611 and a cylindricalstimulation electrode insert612. In one embodiment, this assembly is coupled to a control unit such as120 discussed with respect to FIG. 1. The control unit monitors the pressure measurements received and adaptively stimulates the area of the body that the adhesive conductor of the stimulation electrode comes in contact with in order to provide a cue to produce an appropriate response. For example in one embodiment, the assembly is used to monitor pressure measurements at a fingertip. When the monitored pressure measured by the tactile sensor meets a defined threshold for that assembly location, the control unit generates stimulation waveforms having a defined pulse width, amplitude, frequency, and waveform shape for stimulation of the area based on the specific application. In this manner, finger movement timing for patients suffering from Parkinson's disease can be improved or restored. Cutaneous stimulation is applied or modified when a finger is pressed against a surface provides an orienting tactile cue. In one embodiment, this cue provides a cadence, enabling timed repetitive action.
• FIG. 7 is an illustration of a palm view of one embodiment of a tactile sensor and stimulation glove, shown generally at[0046]700, constructed according to the teachings of the present invention. Aglove785 includes a first and a secondtactile sensor assembly794 and795 respectively. In one embodiment, each tactile sensor assembly includes astimulation electrode793, which is in direct contact with the palm of the hand,glove material792 sandwiched between theelectrode793 and apressure sensor791, and agripping material796, such as rubber, neoprene, or the like, on top ofpressure sensor791. The firsttactile sensor assembly794 is coupled to a firstelectrical lead788 and the secondtactile sensor assembly795 is coupled to a secondelectrical lead789. Eachelectrical lead788 and789 is coupled to a control unit such ascontrol unit120 discussed with respect to120. In one embodiment, the electrical leads provide pressure information to a control unit for a determination of the need for stimulation. In one embodiment,glove785 is fabricated of a material having elastic properties to aid in fitting a variety of different sized hands.
• FIG. 8 is an illustration of a top view of one embodiment of a tactile sensor and stimulation glove, shown generally at[0047]800, constructed according to the teachings of the present invention. Theglove825 includes awire connector819 for connection to additional sensors such as pressure sensor assemblies attached to one or more fingers or thumb, acceleration or pressure sensors attached to the wrist, forearm, upper arm or the like.Wire connector819 includes aconnection cable870 for coupling to a control unit, such ascontrol unit120, of FIG. 1. In one embodiment,connection cable870 comprises all of the wiring to and from the control unit for stimulation and transmission of sensor information. In addition,stimulation glove825 includes acommon return electrode832.Common return electrode832 is in direct contact with the skin and provides the return path for each of the electrical stimulation electrodes attached to the body. It provides a large surface and as a result a lower impedance than each of the stimulation electrodes, this is adapted to aid in keeping the current at the contact location at a comfortable level for the patient. In one embodiment, the common return path includes a lead coupled to the control unit. In another embodiment, the common return path includes a lead withinconnection cable870 coupled to the control unit.
• In one embodiment,[0048]glove825 includes astrain relief824 in order to adjust the placement ofconnection cable870. In one embodiment,glove825 includes anadjustable flap829 which is secured with attachment devices such as snaps, buckles, straps, hook and pile or the like. In one embodiment,glove825 is fabricated of a material having elastic properties. In one embodiment, the features ofstimulation glove785 of FIG. 7 and the features ofstimulation glove825 are combined to create an integrated tactile sensor and stimulation glove which is coupled to a control unit such ascontrol unit120 of FIG. 1. In one embodiment, the integrated tactile sensor andstimulation glove825 includes one or more of the following features: one or more fingertip/thumb pressure/stimulation assemblies, one or more pressure/stimulation assemblies mounted on the palm of the glove, fabricated of flexible material, a wire connector such as819, a connection cable such as870, an adjustable flap such as829 and a strain relief such as827.
• FIG. 9 is an illustration of a top view of one embodiment of a tactile sensor and stimulation glove integrated with finger sensors, shown generally at[0049]900, constructed according to the teachings of the present invention.Glove900 includes awire connector919 coupled to electrical leads963-1 to963-5 that are coupled to tactile sensor and stimulation electrode assemblies950-1 to950-5 respectively. In one embodiment,wire connector919 is coupled toelectrical leads987 and988 that are coupled to first and second tactile sensors (not shown), such assensors794 and795 of FIG. 7.Glove900 further includes a connection cable970 that connectswire connector919 to a control unit, such ascontrol unit120 of FIG. 1. In addition,glove900 includes acommon return electrode932. In one embodiment,glove900 includes one or more tactile sensor and stimulation electrode assemblies950 as required for each application. In an alternate embodiment, additional electrode stimulators may also be attached to stimulate forearm, upper arm, and shoulder.
• FIG. 10 is an illustration of one embodiment of a stimulation and sensing wristband, shown generally at[0050]1000, constructed according to the teachings of the present invention.Wristband1000 includes first and second stimulation electrodes1044-1 and1044-2 located on the left and right sides of the wrist. In one embodiment,wristband1000 includes a first and a second acceleration sensor (accelerometers)1042-1 and1042-2 located on the top and bottom sides of the wrist.Wristband1000 includes a first and a second electrical lead1046-1 and1046-2 coupled to the first and second stimulation electrodes1044-1 and1044-2, respectively. In one embodiment, the electrical leads1046-1 and1046-2 couple to a common wire connector such as thewire connector919 of FIG. 9. In another embodiment, the electrical leads1046-1 and1046-2 are directly coupled to a control unit such ascontrol unit120 discussed with respect to FIG. 1. Electrical stimulation signals and electrical information signals are sent and received via the electrical leads1046-1 and1046-2. In one embodiment,wristband1000 is fabricated of a material that has elastic properties such that the wristband is adjustable to fit a variety of different sized wrists. It is understood that the number and placement of stimulation electrodes and sensors are for illustration and alternate embodiments may include an appropriate configuration of stimulation electrodes and types of sensors for each application.
• FIG. 11 is an illustration of one embodiment of a shoe insert, shown generally at[0051]1100, constructed according to the teachings of the present invention. In one embodiment,shoe insert1100 includes first, second and third pressure sensors1143-1 to1143-3 located under the toes, on the ball of the foot and on the heel of the foot respectively. In addition,shoe insert1100 includes anelectrical lead1145 coupled to each of pressure sensors1143-1 to1143-3. In one embodiment,electrical lead1145 is coupled to a control unit such ascontrol unit120 discussed with respect to FIG. 1. Pressure information is transmitted to the control unit for a determination of the need for stimulation. In an alternate embodiment,shoe insert1100 includes any number of electrical leads attached to sensors based on each application. It is understood that the number, type and location of sensors1143 are for illustration only and alternate embodiments may include an appropriate configuration of sensors for each application.
• FIG. 12 is an illustration of one embodiment of a sock insert, shown generally at[0052]1200, constructed according to the teachings of the present invention. In one embodiment,sock insert1200 includes stimulation electrodes1247-1 to1247-3. In one embodiment, stimulation electrodes1247-1 to1247-3 include an adhesive conductive gel pad that is in direct contact with the foot. In one embodiment, stimulation electrode1247-1 is located under the toes and includesridges1298 to aid in cupping the toes for direct contact with the toes.Sock insert1200 includeselectrical lead1253 that is coupled to each of stimulation electrodes1247-1 to1247-3. In one embodiment,electrical lead1253 is in coupled to a control unit such ascontrol unit120 of FIG. 1. Electrical pulses are transmitted to each of stimulation electrodes1247-1 to1247-3 as required for each application. In an alternate embodiment,sock insert1200 includes any number of electrical leads attached to stimulation electrodes in order to control stimulation to the foot based on each application.Sock insert1200 includes acommon return electrode1251 that is attached to the top of the foot.Common return electrode1251 is coupled toelectrical lead1254 that is coupled to the control unit and provides the return path for the electrical stimulation pulses.
• In one embodiment,[0053]shoe insert1100 andsock insert1200 are integrated to create an adaptive electrical stimulator.
• FIG. 13 is an illustration of one embodiment of a stimulation and sensing ankle band, shown generally at[0054]1300, constructed according to the teachings of the present invention.Ankle band1300 includes first and second stimulation electrodes1371-1 and1371-2 located on the front and back sides of the ankle, respectively. In one embodiment,ankle band1300 includes first and second acceleration sensors (accelerometers)1368-1 and1368-2 located on the left and right sides of the ankle, respectively.Ankle band1300 includes first and second electrical leads1366-1 and1366-2 coupled to the first and second stimulation electrodes1371-1 and1371-2 respectively. In one embodiment, electrical leads1366-1 and1366-2 are coupled to a control unit such ascontrol unit120 of FIG. 1. Electrical stimulation pulses are provided to stimulation electrodes1371-1 and1371-2 via electrical leads1366-1 and1366-2, respectively.Ankle band1300 includes electrical leads (not shown) from the control unit to acceleration sensors1368-1 and1368-2 in order to receive acceleration information. In one embodiment,ankle band1300 is fabricated of a material that has elastic properties such that the ankle band is adjustable for a variety of different sized ankles. It is understood that the number and placement of stimulation electrodes and sensors are for illustration and alternate embodiments may include an appropriate configuration of stimulation electrodes and types of sensors for each application.
• FIG. 14 is an illustration of one embodiment of a stimulation and sensing headband, shown generally at[0055]1400, constructed according to the teachings of the present invention.Headband1400 includes a first and a second stimulation electrode1472-1 and1472-2 located on the right and left front of the head, respectively. In addition,headband1400 includes a first electrical lead1475-1 coupled to the first stimulation electrode1472-1 and a second electrical lead1475-2 coupled to the second stimulation electrode1472-2. The first and second electrical leads1475-1 and1475-2 are each coupled to a control unit such ascontrol unit120 of FIG. 1. The control unit transmits electrical stimulation signals to the electrical stimulation electrodes1472-1 and1472-2 via electrical leads1475-1 and1475-2 respectively. Electrical stimulation electrodes1472-1 and1472-2 are in direct contact with the skin. In one embodiment, electrical stimulation electrodes1472-1 and1472-2 each comprise conductive adhesive gel for electrically coupling the electrodes to the skin. In one embodiment,headband1400 includes accelerometers1486-1 to1486-P as required for each application. In one embodiment, accelerometers1486-1 to1486-P are located on the sides, front and back of the head. In one embodiment,headband1400 includes inclination sensors1473-1 to1473-N as required for each application. In one embodiment, inclination sensors1473-1 to1473-N are located on the sides, front and back of the head. It is understood that the number and placement of stimulation electrodes and sensors are for illustration and alternate embodiments may include an appropriate configuration of stimulation electrodes and types of sensors for each application.
• FIG. 15 is an illustration of one embodiment of a stimulation neckband, shown generally at[0056]1500, constructed according to the teachings of the present invention. Stimulation neckband includes stimulation electrodes1576-1 and1576-2. In one embodiment, stimulation electrodes1576-1 and1576-2 are located at the left and right rear of the neck. In alternate embodiments, stimulation electrodes such as1576 are strategically located for the specific application. In one embodiment, each stimulation electrode1576-1 and1576-2 is coupled to an electrical lead (not shown) that is coupled to a control unit such ascontrol unit120 and transmits electrical stimulation pulses from the control unit to the electrode. In one embodiment, stimulation neckband includes inclination sensors coupled to the control unit. The inclination sensors provide inclination information for a determination by the control unit for the need for stimulation. It is understood that the number and placement of stimulation electrodes and sensors are for illustration and alternate embodiments may include an appropriate configuration of stimulation electrodes and types of sensors for each application.
• In one embodiment, impaired voluntary movements (akinesia) are broken using aural, visual, or tactile external stimulation. Synthesized tactile stimulation with an adaptive stimulator will provide the cues to enable properly timed repetitive motion.[0057]
• FIG. 16 is a flow diagram of one embodiment of a method of adaptive stimulation for the treatment of the symptoms of Parkinson's disease according to the teachings of the present invention. The method at[0058]1600 receives one or more input signals from at least one sensor such as pressure, inclination, acceleration or the like, wherein the input signals are based on physical stimulus. The method proceeds to1610 and monitors the received input signals. The method then proceeds to1620 and determines if the input signals meet defined criteria. If the input signals meet defined criteria the method proceeds to1630 and generates one or more stimulation signals. If the input signals do not meet defined criteria, the method proceeds to1610 and continues to monitor the input signals. In addition, when the input signals meet defined criteria the method continues to monitor the input signals while the method proceeds. Once the stimulation signals are generated the method proceeds to1640 and transmits the one or more stimulation signals to one or more stimulators.
• In one embodiment, the method further includes monitoring stimulation electrode voltage and current to prevent exposure of the patient to uncomfortable stimulation levels.[0059]
• In one embodiment, the input signals include pressure, acceleration, inclination information and the like from strategically positioned sensors. In alternate embodiments, the input signals include information from an operator control panel and/or a remotely located processing unit. In one embodiment, an operator to include the patient, a technician, a physician or the like controls the input signals from the operator control panel.[0060]
• In one embodiment, the input signals are received from a number of sensors for example pressure and acceleration sensors that are mounted on one or more wearable devices such as a headband, a wristband and/or an ankle band. In an alternate embodiment, input signals include operator control signals. A control unit receives the input signals and determines a response based on the input signals. In one embodiment, the response may include aural stimulation, electrical stimulation, and/or sonic stimulation as well as frequency, amplitude, pulse width, waveform shape and duration of stimulation. In one embodiment, the response to input signals includes cadence simulation, tactile simulation, sequenced stimulation or the like.[0061]
• In one embodiment, the control unit transmits information about the inputs or the stimulation signals to a display. In another embodiment, the control unit wirelessly transmits information to a remote processing unit for data collection or processing.[0062]
• For example, in one embodiment, the control unit receives inputs that indicate little or no motion (acceleration) at the wrist, potentially signaling that the patient has stopped swinging his/her arm while walking, the patient has stopped walking, the patient is having trouble initiating movement in the arm and the like. As a response the control unit provides stimulation at the wrist in a cadence that emulates the patients normal gait or a stimulation at one or more of the wrist, forearm, hand, upper arm or the like, to cue the patient to move their arm. Each application of an adaptive stimulator is individualized and requires criteria for each patient. The control unit is programmable for each patient to respond based on a set of criteria. In one embodiment, a control unit is programmed to provide electrical stimulation and if the electrical stimulation does not produce the desired result the control unit will adapt to change the voltage, frequency, pulse width, amplitude, waveform and/or the like of the electrical stimulation signals. In an alternate embodiment, the control unit detects that the provided stimulation has not produced the desired result and changes the type of stimulation e.g. from electrical to aural, from aural to electrical, or the like. In a further embodiment, the control unit changes the sequence or the cadence of the stimulation.[0063]
• In one embodiment, the stimulators comprise stimulation electrodes. In an alternate embodiment, the stimulators comprise sonic stimulators. In a further embodiment, the stimulators comprise aural stimulators. It is understood that the number and type of stimulators is not limited and adaptively stimulating a region of the body to aid in treatment of the symptoms of Parkinson's disease may include any number or type of stimulators and stimulator combinations. In addition, each application can be individualized.[0064]
• FIG. 17 is a schematic of one embodiment of an adaptive stimulator, shown generally at[0065]1700, constructed according to the teachings of the present invention.Stimulator1700 includes acontrol unit1722 and a plurality of sensors coupled to the control unit. The sensors include but are not limited toaccelerometers1704,inclination sensors1707, and tactile sensors1702-1 to1702-K. In one embodiment, the tactile sensors1702-1 to1702-K include pressure sensors. In one embodiment,control unit1722 is also coupled to a plurality of stimulators to include anaural stimulator1777, stimulation electrodes1730-1 to1730-L andsonic stimulator1778. In addition,stimulator1700 includes a display andcontrol panel1723. In one embodiment, the display is a liquid crystal display.
• In operation, the[0066]control unit1722 receives information from one ormore sensors1704,1707,1702 and determines when and if aural, electrical, sonic or the like stimulation is required. Thecontrol unit1722 then provides the required stimulation and continues to monitor information received and adapts to modify the type of stimulation, duration, frequency, amplitude and the like in order to produce the desired results, e.g., movement of a finger or fingers, legs, arm or the like, lifting of the head, movement of the body, etc. In one embodiment,control unit1722 collects and stores information about inputs to and outputs fromcontrol unit1722. In one embodiment, the information is stored in a database or memory device.
• In one embodiment, timing signals are generated by micro-code of[0067]control unit1722. The micro-code determines the pulse width and frequency for each pulse. For each pulse generated, power field effect transistors (FETs) G12 and G13 are gated “on” to allow current flow through the primary of the transformer T1. In this embodiment, two field effect transistors G12 and G13 are used and individually controlled to prevent a single input/output or FET failure from applying a continuous direct current to the transformer T1.
• Current flows through the current limiting resistor R[0068]2, the transformer T1 primary, FETs G12 and G13, amplitude control potentiometer P3, and current monitoring resistor R3 inducing a current in the secondary. FET G12 is then gated off and current flows through diode D1. Amplitude control is provided by potentiometer P3 through primary field current limiting. Monitoring of analog inputs I2 and I3 provides an indication of the voltage applied to and current flowing through the primary. Using the turn's ratio, secondary voltage and current may be approximated.
• Secondary voltage is rectified using a full wave bridge B[0069]1. The positive side of the bridge is connected to the positive return electrode. A single stimulation electrode1730-1 to1730-L is enabled for each pulse out of the transformer secondary. Current monitoring resistor R4 provides the mechanism for monitoring of secondary current by the control unit1733 through analog input I6. Enabling FET G11 facilitates monitoring of a fixed load secondary voltage. This enables current flow through resistor R5 forming a resistive bridge with current monitoring resistor R4. Based on current flow and known resistance value R5, secondary voltage may be approximated.
• In one embodiment, a manual shunt of the stimulation electrode voltage is accomplished through human activation of switch S[0070]1. This disconnects thecommon return electrode1767 and shunts the current through resistor R6. This produces a transformer secondary over-current status condition incontrol unit1722 that shuts down the pulse generation on the primary. In one embodiment, thecontrol unit1722 will then attempt to reset the pulse generation every three to five seconds while continuing to disable the stimulation electrodes1730-1 to1730-L. The stimulation electrodes1730-1 to1730-L will not be enabled until it is determined that the voltage adjustment potentiometer P3 has been readjusted to a lower value.
CONCLUSION
• An adaptive stimulator has been described. The stimulator includes a control unit and at least one stimulation electrode coupled to an output of the control unit. The at least one stimulation electrode is adapted to provide stimulation to an area of the body of a living subject. The adaptive stimulator includes at least one sensor coupled to the control unit and adapted to be disposed external to the human body. The sensor is adapted to respond to physical stimulus and provide input to the control unit. The adaptive stimulator is adapted to selectively provide stimulation in response to the control unit.[0071]
• In addition, a method of adaptive stimulation has been described. The method includes receiving one or more input signals. At least one of the input signals is based on physical stimulus. The method also includes monitoring the received input signals and selectively generating one or more stimulation signals when the one or more input signals meet defined criteria. The method further includes transmitting the one or more stimulation signals to an area of the body of a living subject. The one or more stimulation signals aid in the relief of symptoms of neurological disorders.[0072]
• Further, a control unit adapted to aid in the relief of symptoms of Parkinson's disease has been described. The control unit includes an input that is adapted to couple to one or more sensors that are adapted to respond to physical stimulus. The control unit also includes a controller that is coupled to the input and a waveform generator coupled to the controller. The control unit further includes an output coupled to the controller and adapted to couple to one or more stimulation electrodes that are adapted to provide stimulation to an area on the human body. In addition, the control unit includes a stimulation voltage pulse generator coupled to the controller.[0073]
• Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement, which is calculated to achieve the same purpose, may be substituted for the specific embodiments shown. For example, although this technology is primarily being developed to relieve symptoms of neurological diseases, it has potential for application in other areas. These include symptomatic relief for other disorders, such as, Huntington's disease and rehabilitation therapy for neurological damage. Other applications may include incorporation into flight suits to prevent spatial disorientation of aircrew undergoing high acceleration maneuvers and potential for relieving symptoms of motion sickness. In addition, although the device is primarily designed for an electrical stimulation output stage, it can be modified to provide topical, sonic, aural stimulation or the like.[0074]
• This application is intended to cover any adaptations or variations of the present invention. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.[0075]

Claims (14)

What is claimed is:

1. A method of cueing an individual to facilitate restoration of impaired voluntary movement, the method comprising:

receiving one or more input signals based on human body functions from at least one sensor;

when the one or more input signals meet a defined criteria, indicating impaired voluntary movement, generating one or more sensory cues, wherein the one or more sensory cues include tactile cues, aural cues, and visual cues;

selectively transmitting stimulation signals to produce the one or more sensory cues; and

selectively adjusting the one or more sensory cues when the impaired voluntary movement is not broken.

2. The method ofclaim 1, wherein the human body functions include tactility, movement and placement.

3. The method ofclaim 1, wherein selectively adjusting the one or more sensory cues includes altering the cadence of the one or more sensory cues.

4. The method ofclaim 1, wherein selectively adjusting the one or more sensory cues includes adjusting the perceived intensity of the one or more sensory cues.

5. The method ofclaim 1, further comprising storing information about the input signals and the stimulation signals.

6. The method ofclaim 5, wherein storing information includes the number and type of sensory cues.

7. The method ofclaim 1, wherein generating tactile cues comprises generating tactile cues using one or more of cutaneous electrical stimulation and sonic stimulation.

8. The method ofclaim 7, wherein selectively adjusting the one or more sensory cues includes adjusting voltage and current levels of the tactile cues.

9. The method ofclaim 7, further comprising preventing exposure of the patient to uncomfortable stimulation levels by monitoring the voltage and current of the tactile cues and feeding the information back to a control unit for further processing.

10. The method ofclaim 1, further comprising producing sequenced stimulation patterns.

11. The method ofclaim 1, further comprising retrieving prior impaired voluntary movement information for the individual.

12. The method ofclaim 1, wherein generating one or more sensory cues comprises selectively transmitting signals to one or more stimulators to produce the one or more sensory cues.

13. The method ofclaim 11, wherein selectively adjusting the one or more sensory cues comprises selectively adjusting the one or more sensory cues based on the prior impaired voluntary movement information for the individual.

14. The method ofclaim 12, wherein the sensory cues are based on the one or more input signals and the prior impaired voluntary movement information.

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