WO2016134273A1 - Stimulateur topique de nerf et capteur pour la gestion de la douleur - Google Patents

Stimulateur topique de nerf et capteur pour la gestion de la douleur Download PDF

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Publication number
WO2016134273A1
WO2016134273A1 PCT/US2016/018705 US2016018705W WO2016134273A1 WO 2016134273 A1 WO2016134273 A1 WO 2016134273A1 US 2016018705 W US2016018705 W US 2016018705W WO 2016134273 A1 WO2016134273 A1 WO 2016134273A1
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Prior art keywords
stimulation
nerve
alpha
pain
tnss
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PCT/US2016/018705
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English (en)
Inventor
Graham H. Creasey
Hoo-Min Toong
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Creasey Graham H
Hoo-Min Toong
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Publication of WO2016134273A1 publication Critical patent/WO2016134273A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
    • A61N1/36175—Pulse width or duty cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071—Pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A61N1/36139—Control systems using physiological parameters with automatic adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
    • A61N1/36178—Burst or pulse train parameters

Definitions

  • Mammalian and human nerves control organs and muscles. Artificially stimulating the nerves elicits desired organ and muscle responses. Accessing the nerves to selectively control these responses from outside the body, without invasive implants or needles penetrating the dermis, muscle or fat tissue is desired.
  • a Topical Nerve Stimulator and Sensor (TNSS) device described in the related United States Patent Application Serial No. PCT/US 14/40240 filed May 30, 2014 is used to stimulate nerves.
  • a TNSS may apply electrode generated electric field(s) in a low frequency to dermis in the proximity of a nerve-and typically applies such a field in the magnitude of kilohertz (KHz).
  • KHz kilohertz
  • the TNSS also includes hardware and logic for high frequency (GHz) communication to mobile devices.
  • a wireless system including a TNSS device is described herein. Its components, features and performance characteristics are set forth in the following technical description. Advantages of a wireless TNSS system over existing transcutaneous electrical nerve stimulation devices are:
  • multiple electrodes of a TNSS can form an array to shape an electric field in the tissues
  • multiple TNSS devices can form an array to shape an electric field in the tissues; [0008] multiple TNSS devices can stimulate multiple structures, coordinated by a smartphone;
  • transmitting antenna of TNSS device can focus beam of electromagnetic energy within tissues in short bursts to activate nerves directly without implanted devices;
  • TNSS devices are expected to have service lifetimes of days to weeks and their disposability places less demand on power sources and battery
  • multiple TNSS devices can form a network with each other, with remote controllers, with other devices, with the internet and with other users;
  • a nerve cell normally has a voltage across the cell membrane of 70 millivolts with the interior of the cell at a negative voltage with respect to the exterior of the cell. This is known as the resting potential and it is normally maintained by metabolic reactions which maintain different
  • Ions can be actively "pumped” across the cell membrane through ion channels in the membrane that are selective for different types of ion, such as sodium and potassium.
  • the channels are voltage sensitive and can be opened or closed depending on the voltage across the membrane.
  • An electric field produced within the tissues by a stimulator can change the normal resting voltage across the membrane, either increasing or decreasing the voltage from its resting voltage.
  • a decrease in voltage across the cell membrane to about 55 millivolts opens certain ion channels, allowing ions to flow through the membrane in a self-catalyzing but self-limited process which results in a transient decrease of the trans membrane potential to zero, and even positive, known as depolarization followed by a rapid restoration of the resting potential as a result of active pumping of ions across the membrane to restore the resting situation which is known as repolarization.
  • This transient change of voltage is known as an action potential and it typically spreads over the entire surface of the cell. If the shape of the cell is such that it has a long extension known as an axon, the action potential spreads along the length of the axon. Axons that have insulating myelin sheaths propagate action potentials at much higher speeds than those axons without myelin sheaths or with damaged myelin sheaths.
  • the action potential reaches a junction, known as a synapse, with another nerve cell
  • the transient change in membrane voltage results in the release of chemicals known as neuro-transmitters that can initiate an action potential in the other cell.
  • This provides a means of rapid electrical communication between cells, analogous to passing a digital pulse from one cell to another.
  • the action potential reaches a synapse with a muscle cell it can initiate an action potential that spreads over the surface of the muscle cell.
  • This voltage change across the membrane of the muscle cell opens ion channels in the membrane that allow ions such as sodium, potassium and calcium to flow across the membrane, and can result in contraction of the muscle cell.
  • the voltage across the membrane of a cell can be changed by creating an electric field in the tissues with a stimulator. It is important to note that action potentials are created within the mammalian nervous system by the brain, the sensory nervous system or other internal means. These action potentials travel along the body's nerve "highways".
  • the TNSS creates an action potential through an externally applied electric field from outside the body. This is very different than how action potentials are naturally created within the body.
  • electric fields capable of causing action potentials can be generated by electronic stimulators connected to electrodes that are implanted surgically in close proximity to the target nerves.
  • electronic devices located on the surface of the skin.
  • Such devices typically use square wave pulse trains of the form shown in Figure 3.
  • Such devices may be used instead of implants and/or with implants such as reflectors, conductors, refractors, or markers for tagging target nerves and the like, so as to shape electric fields to enhance nerve targeting and/or selectivity.
  • the amplitude of the pulses, A, applied to the skin may vary between 1 and 100 Volts, pulse width, t, between 100 microseconds and 10 milliseconds, duty cycle (t/T) between 0.1% and 50%, the frequency of the pulses within a group between 1 and 100/sec, and the number of pulses per group, n, between 1 and several hundred.
  • pulses applied to the skin will have an amplitude of up to 60 volts, a pulse width of 250 microseconds and a frequency of 20 per second, resulting in a duty cycle of 0.5%.
  • balanced-charge biphasic pulses will be used to avoid net current flow.
  • these pulses may be symmetrical, with the shape of the first part of the pulse similar to that of the second part of the pulse, or asymmetrical, in which the second part of the pulse has lower amplitude and a longer pulse width in order to avoid canceling the stimulatory effect of the first part of the pulse.
  • the location and magnitude of the electric potential applied to the tissues by electrodes provides a method of shaping the electrical field. For example, applying two electrodes to the skin, one at a positive electrical potential with respect to the other, can produce a field in the underlying tissues such as that shown in the cross-sectional diagram, Figure 5.
  • the diagram in Figure 5 assumes homogeneous tissue.
  • the voltage gradient is highest close to the electrodes and lower at a distance from the electrodes. Nerves are more likely to be activated close to the electrodes than at a distance. For a given voltage gradient, nerves of large diameter are more likely to be activated than nerves of smaller diameter. Nerves whose long axis is aligned with the voltage gradient are more likely to be activated than nerves whose long axis is at right angles to the voltage gradient.
  • FIG. 6 applying similar electrodes to a part of the body in which there are two layers of tissue of different electrical resistivity, such as fat and muscle, can produce a field such as that shown in Figure 6. Layers of different tissue may act to refract and direct energy waves and be used for beam aiming and steering. An individual's tissue parameters may be measured and used to
  • the pulse trains can differ from one another indicated by A, t/T, n, and f as well as have different phase relationships between the pulse trains.
  • combinations of electrodes can be utilized ranging from simple dipoles, to quadripoles, to linear arrangements, to approximately circular configurations, to produce desired electric fields within tissues.
  • the present system uses beam selection to move or shift or shape an electric field, also described as field steering or field shaping, by activating different electrodes, such as from an array of electrodes, to move the field. Selecting different combinations of electrodes from an array may result in beam or field steering. A particular combination of electrodes may shape a beam and/or change the direction of a beam by steering. This may shape the electric field to reach a target nerve selected for stimulation.
  • Electrodes to be implanted surgically on or near nerves.
  • Using electrodes on the surface of the skin to focus activation selectively on nerves deep in the tissues has many advantages. These include avoidance of surgery, avoidance of the cost of developing complex implants and gaining regulatory approval for them, and avoidance of the risks of long-term implants.
  • the features of the electric field that determine whether a nerve will be activated to produce an action potential can be modeled mathematically by the Activating Function described by Rattay (Rattay F. The basic mechanism for the electrical stimulation of the nervous system. Neuroscience Vol. 89, No. 2, pp. 335- 346, 1999).
  • the electric field can produce a voltage, or extracellular potential, within the tissues that varies along the length of a nerve. If the voltage is
  • the Activating Function is proportional to the second-order spatial derivative of the extracellular potential along the nerve. If it is sufficiently greater than zero at a given point it predicts whether the electric field will produce an action potential in the nerve at that point. This prediction may be input to a nerve signature.
  • the nerve to be activated must be accurately selected. This selectivity may be improved by using the system described herein, and described herein as a nerve signature, in several ways, as follows:
  • TNSS 934 human and mammalian interface and its method of operation and supporting system are managed by a Master Control Program (MCP) 910 represented in function format as block diagrams. It provides the logic for the nerve stimulator system.
  • MCP Master Control Program
  • the primary responsibility of the MCP 910 is to coordinate the activities and communications among the various control programs, the Data Manager 920, the User 932, and the external ecosystem and to execute the appropriate response algorithms in each situation.
  • the MCP 910 accomplishes electric field shaping and/or beam steering by providing an electrode activation pattern to the TNSS device 934 to selectively stimulate a target nerve.
  • the MCP 910 upon notification by the Communications Controller 930 of an external event or request, the MCP 910 is responsible for executing the appropriate response, working with the Data Manager 920 to formulate the correct response and actions. It integrates data from various sources such as Sensors 938 and external inputs such as TNSS devices 934, and applies the correct security and privacy policies, such as encryption and HIPAA required protocols.
  • the MCP is also responsible for effectively managing power consumption by the TNSS device through a combination of software algorithms and hardware components that may include, among other things: computing, communications, and stimulating electronics, antenna, electrodes, sensors, and power sources in the form of conventional or printed batteries.
  • the communications controller is responsible for receiving inputs from the User 932, from a plurality of TNSS devices 934, and from 3rd party apps 936 via communications sources such as Internet or cellular networks.
  • the format of such inputs will vary by source and must be received, consolidated, possibly reformatted, and packaged for the Data Manager 920.
  • User inputs may consist of simple requests for activation of TNSS devices 934 to status and information concerning the User's 932 situation or needs.
  • TNSS devices 934 will provide signaling data that may consist of voltage readings, TNSS 934 status data, responses to control program inquiries, and other signals.
  • the Communications Controller 930 is also responsible for sending data and control requests to the plurality of TNSS devices 934.
  • 3rd party applications 936 can send data, requests, or instructions for the Master Control Program 910 or User 932 via Internet or cellular networks.
  • the Communications Controller 930 is also responsible for communications via the cloud where various software applications reside.
  • the Data Manager (DM) 920 has primary responsibility for the storage and movement of data to and from the Communications Controller 930, Sensors 938, Actuators 940, and the Master Control Program 910.
  • the DM 920 has the capability to analyze and correlate any of the data under its control. It provides logic to select and activate nerves. Examples of such operations upon the data include: statistical analysis and trend identification; machine learning algorithms; signature analysis and pattern recognition, correlations among the data within the Data Warehouse 926, the Therapy Library 922, the Tissue Models 924, and the Electrode Placement Models 928, and other operations.
  • the Data Warehouse (DW) 926 is where incoming data is stored
  • this data can be real-time measurements from TNSS devices 934 or from Sensors (938), data streams from the Internet, or control and instructional data from various sources.
  • the DM 920 will analyze data, as specified above, that is held in the DW 926 and cause actions, including the export of data, under MCP 910 control. Certain decision making processes implemented by the DM 920 will identify data patterns both in time, frequency, and spatial domains and store them as signatures for reference by other programs. Techniques like EMG, even multi- electrode EMG, gather a lot of data that is the sum of hundreds to thousands of individual motor units and the normal procedure is to perform complex
  • the DM 920 will perform big data analysis over the total signal and recognize patterns that relate to specific actions or even individual nerves or motor units. This analysis can be performed over data gathered in time from an individual, or over a population of TNSS Users.
  • the Therapy Library 922 contains various control regimens for the TNSS devices 934.
  • Regimens specify the parameters and patterns of pulses to be applied by the TNSS devices 934.
  • the width and amplitude of individual pulses may be specified to stimulate nerve axons of a particular size selectively without
  • the frequency of pulses applied may be specified to modulate some reflexes selectively without modulating other reflexes.
  • Tissue Models 924 are specific to the electrical properties of particular body locations where TNSS devices 934 may be placed. As noted previously, electric fields for production of action potentials will be affected by the different electrical properties of the various tissues that they encounter. Tissue Models 924 are combined with regimens from the Therapy Library 922 and
  • Electrode Placement Models 928 to produce desired actions.
  • Tissue Models 924 may be developed by MRI, Ultrasound or other imaging or measurement of tissue of a body or particular part of a body. This may be accomplished for a particular User 932 and/or based upon a body norm.
  • One such example embodiment of a desired action is the use of a Tissue Model 924 together with a particular Electrode Placement Model 928 to determine how to focus the electric field from electrodes on the surface of the body on a specific deep location corresponding to the pudendal nerve in order to stimulate that nerve selectively to reduce incontinence of urine.
  • Other example embodiments of desired actions may occur when a Tissue Model 924 in combination with regimens from the Therapy Library 22 and
  • Electrode Placement Models 928 produce an electric field that stimulates a sacral nerve. Many other embodiments of desired actions follow for the stimulation of other nerves.
  • Electrode Placement Models 928 specify electrode configurations that the TNSS devices 934 may apply and activate in particular locations of the body. For example, a TNSS device 934 may have multiple electrodes and the Electrode Placement Model 928 specifies where these electrodes should be placed on the body and which of these electrodes should be active in order to stimulate a specific structure selectively without stimulating other structures, or to focus an electric field on a deep structure.
  • An example embodiment of an electrode configuration is a 4 by 4 set of electrodes within a larger array of multiple electrodes, such as an 8 by 8 array.
  • This 4 by 4 set of electrodes may be specified anywhere within the larger array such as the upper right corner of the 8 by 8 array.
  • Other example embodiments of electrode configurations may be circular electrodes that may even consist of concentric circular electrodes.
  • the TNSS device 934 may contain a wide range of multiple electrodes of which the Electrode Placement Models 928 will specify which subset will be activated. These Electrode Placement Models 928 complement the regimens in the Therapy Library 922 and the Tissue Models 924 and are used together with these other data components to control the electric fields and their interactions with nerves, muscles, tissues and other organs.
  • Other examples may include TNSS devices 934 having merely one or two electrodes, such as but not limited to those utilizing a closed circuit.
  • Independent sensors 938 and actuators 940 can be part of the TNSS system. Its functions can complement the electrical stimulation and electrical feedback that the TNSS devices 934 provide.
  • An example of such a sensor 938 and actuator 940 include, but are not limited to, an ultrasonic actuator and an ultrasonic receiver that can provide real-time image data of nerves, muscles, bones, and other tissues. Other examples include electrical sensors that detect signals from stimulated tissues or muscles.
  • the Sensor/Actuator Control module 950 provides the ability to control both the actuation and pickup of such signals, all under control of the MCP 910.
  • the MCP 910 is also responsible for supervising the various Application Program Interfaces (APIs) that will be made available for 3rd party developers.
  • APIs Application Program Interfaces
  • Another group of healthcare professionals may desire access to the Therapy Library 922 and Tissue Models 924 to construct better regimens for addressing specific diseases or disabilities. In each case a different specific API 914 may be appropriate.
  • the MCP 910 is responsible for many software functions of the TNSS system including system maintenance, debugging and troubleshooting functions, resource and device management, data preparation, analysis, and communications to external devices or programs that exist on the smart phone or in the cloud, and other functions. However, one of its primary functions is to serve as a global request handler taking inputs from devices handled by the Communications
  • MCP High Level Master Control Program
  • the Request Handler (RH) 960 accepts inputs from the User 932, TNSS devices 934, 3rd party apps 936, sensors 938 and other sources. It determines the type of request and dispatches the appropriate response as set forth in the following paragraphs.
  • the RH 960 will determine which of the plurality of User Requests 961 is present such as: activation; display status, deactivation, or data input, e.g. specific User condition. Shown in Figure 9B is the RH's 960 response to an activation request. As shown in block 962, RH 960 will access the Therapy Library 922 and cause the appropriate regimen to be sent to the correct TNSS 934 for execution, as shown at block 964 labeled "Action.”
  • TNSS/Sensor Inputs The RH 960 will perform data analysis over TNSS 934 or Sensor inputs 965. As shown at block 966, it employs data analysis, which may include techniques ranging from DSP decision making processes, image processing algorithms, statistical analysis and other algorithms to analyze the inputs. In Figure 9B two such analysis results are shown; conditions which cause a User Alarm 970 to be generated and conditions which create an Adaptive Action 980 such as causing a control feedback loop for specific TNSS 934 functions, which of course can iteratively generate further TNSS 934 or Sensor inputs 965 in a closed feedback loop.
  • data analysis may include techniques ranging from DSP decision making processes, image processing algorithms, statistical analysis and other algorithms to analyze the inputs.
  • FIG 9B two such analysis results are shown; conditions which cause a User Alarm 970 to be generated and conditions which create an Adaptive Action 980 such as causing a control feedback loop for specific TNSS 934 functions, which of course can iteratively generate further TNSS 934 or
  • 3rd Party Apps can communicate with the MCP 910, both sending and receiving communications.
  • a typical communication would be to send informational data or commands to a TNSS 934.
  • the RH 960 will analyze the incoming application data, as shown at block 972.
  • Figure 9B shows two such actions that result.
  • One action, shown at block 974 would be the presentation of the application data, possibly reformatted, to the User 932 through the MCP User Interface 912.
  • Another result would be to perform a User 932 permitted action, as shown at 976, such as requesting a regimen from the Therapy Library 922.
  • an example TNSS is shown.
  • the TNSS has one or more electronic circuits or chips 1000 that perform the functions of:
  • TNSS interfaces to transducers 1014 to transmit signals to the tissue or to receive signals from the tissue.
  • One arrangement is to integrate a wide variety of these functions into an SOC, system on chip 1000.
  • a control unit 1002 for data processing, communications, transducer interface and storage and one or more stimulators 1004 and sensors 1006 that are connected to electrodes 1008.
  • An antenna 1010 is incorporated for external communications by the control unit.
  • an internal power supply 1012 which may be, for example, a battery.
  • An external power supply is another variation of the chip configuration. It may be necessary to include more than one chip to accommodate a wide range of voltages for data processing and stimulation. Electronic circuits and chips will communicate with each other via conductive tracks within the device capable of transferring data and/or power.
  • the TNSS interprets a data stream from the control device, such as that shown in Figure 9 A, to separate out message headers and delimiters from control instructions.
  • control instructions contain information such as voltage level and pulse pattern.
  • the TNSS activates the stimulator 1004 to generate a stimulation signal to the electrodes 1008 placed on the tissue according to the control instructions.
  • the TNSS activates a transducer 1014 to send a signal to the tissue.
  • control instructions cause information such as voltage level and pulse pattern to be retrieved from a library stored in the TNSS.
  • TNSS receives sensory signals from the tissue and translates them to a data stream that is recognized by the control device, such as the example in Figure 9A.
  • Sensory signals include electrical, mechanical, acoustic, optical and chemical signals among others.
  • Sensory signals come to the TNSS through the electrodes 1008 or from other inputs originating from mechanical, acoustic, optical, or chemical transducers. For example, an electrical signal from the tissue is
  • acoustic signal is received by a transducer 1014 in the TNSS, converted from an analog signal to a digital signal and then inserted into a data stream that is sent through the antenna 1010 to the control device.
  • sensory signals from the tissue are directly interfaced to the control device for processing.
  • C fibers account for about 70% of all pain fibers.
  • A-delta fibers conduct sharp acute pain faster than the more diffuse dull pain signals from C fibers. The signals from A-delta fibers are responsible for the withdrawal reflex that occurs within milliseconds from the initial stimulation. Because of the relative differences in conduction speeds between the myelinated A-delta and non-myelinated C fibers, the arrival of action potentials at the central nervous system upon pain stimulation occurs at different times with C fiber activation, occurring well after A-delta action potentials which in turn arrive after A-alpha and A-beta action potentials.
  • pain pathways from the peripheral nerves described above ascend in the central nervous system to make connections to both the midbrain 1240, the brainstem and the higher centers of the brain 1250, all of which can return efferent signals downwards to various levels of the spinal cord where they interact with inhibitory interneurons and can produce analgesia or diffuse inhibition of the ascending pain signals.
  • neurotransmitters and brain structures such as the amygdala and the periaqueductal grey matter.
  • the perception of pain can be reduced or abolished by initiating action potentials in larger diameter A-alpha and A-beta nerves 1110 ( Figure 11) that will modulate or block the perception of pain transmitted through smaller diameter A- delta and C nerves 1100.
  • the larger nerves can be stimulated mechanically by rubbing a portion of the body surface over the injury.
  • One model for the modulation of pain signals in this way is based upon the Melzack-Wall gate control theory of pain.
  • the control mechanisms for pain signals can be viewed as a series of filters, or gates, whose closing is controlled by the cortex, the midbrain, the medulla, or other structures using many of the mechanisms described previously.
  • the first control point for action potentials that lead to the perception of pain is near the dorsal root of the spinal cord where the A-delta and C fibers enter the spinal cord 1380.
  • Action potentials from mechanoreceptors that sense touch and pressure (non-nociceptive messages) carried by A-alpha and A-beta nerves also enter the spinal cord in these roots 1390.
  • Both nociceptive 1380 and non-nociceptive signals 1390 converge upon interneurons 1300 and upon projection neurons 1310, which in turn project axons 1330 into the spinothalamic tract ascending pathway.
  • the most important difference between the connections made by the nociceptive and non-nociceptive nerves to the interneurons 1300 is that the nociceptive A-delta, C fibers are inhibitory and the non-nociceptive A-alpha, A-beta fibers are excitatory 1320 to the interneuron 1300. This is the circuit that forms the "gate" for segmental control of pain.
  • the operation of the gate proceeds as follows. Under normal conditions the inhibitory interneuron 1300 spontaneously produces action potentials that cause the projection neuron 1310 not to trigger. However, when a nociceptive fiber is activated by a pain stimulus it inhibits the interneuron 1300 from producing action potentials, which increase the chance that the projection neuron will produce action potentials, and it simultaneously stimulates the projection neuron to produce action potentials along the spinothalamic tract on the ascending pathway up the spinal cord to the brain. This results in pain signals being transmitted by the projection neuron.
  • the interneuron 1300 is stimulated to produce action potentials which in turn inhibit the projection neuron 1310 from sending action potentials on the
  • the non-nociceptive fibers also supply some excitatory stimulation to the projection neuron, but on balance the action potentials produced by the interneuron generally inhibit the projection neuron from firing.
  • the interneuron 1300 will produce a strong hyperpolarization of the projection neuron 1310, thus reducing the chance that the projection neuron will emit action potentials.
  • the larger A-alpha and A-beta fibers can be stimulated electrically to block pain signals traveling in the A-delta and C fibers.
  • the activation thresholds for A-alpha and A-beta fibers are much lower than the activation thresholds for A- delta and C fibers. It is thus possible to activate large A-alpha and A-beta fibers without activating A-delta and C fibers, and this can result in a reduced perception of pain signals that may be traveling in A-delta and C fibers.
  • Transcutaneous electrical nerve stimulation (TENS) devices produce some local analgesia by stimulating the A-alpha, A-beta fibers in the skin.
  • TNSS devices also have the ability to stimulate nerves deep in the body by focusing electric fields within the tissues using electrodes on the surface of the skin. This expands the possibilities of reducing pain beyond current use of transcutaneous electrical nerve stimulation TENS devices, which primarily stimulate surface non-nociceptive fibers. Specific patterns of electrical stimulation coupled with techniques of field steering, beam forming and beam steering may be used to stimulate nerves deep within the tissues. For example, the ability of the TNSS to focus electrical stimulation on nerves deep in soft tissues around the lumbar spine may be useful in reducing low back pain and spasm resulting from disc disease, arthritis and other degenerative conditions of the spine. It may also be useful in many other conditions causing pain where non-invasive and non- medication-based control of pain is desired.
  • the TNSS may in some cases stimulate sensory nerves in the peripheral nervous system that would lead to indirectly activating other parts of the central nervous system or descending neural pathways that provide inhibitory efferent signals from the higher centers of the brain, the midbrain, brainstem, and the spinal cord.
  • Step 1 Referring to Fig 14, User feels in the brain 1409 the perception of pain as a result of signals 1411 from the peripheral nervous system.
  • Step2 User activates the TNSS 1401 via a button on the TNSS or a Control Device 1406 which may be a smartphone or a dedicated device.
  • a dedicated device is a small portable device resembling a key fob and containing electronic circuits for storage and operation of programs and buttons that the user can operate. When the user presses a button on the Control Device this can cause it to transmit radio-frequency signals 1408 to the TNSS to control the operation of the TNSS.
  • the dedicated device can also receive radio-frequency signals 1407 from the TNSS.
  • the TNSS and the Control Device are under software control, responding to an action from the user. There will be safeguards to prevent false activations or unnecessary repetitive activations.
  • Step-3 The activation by the user causes a stimulator in the TNSS to send electrical stimulation signals 1402 to the appropriate nerve(s) 1403 that block the pain signals thereby relieving the pain as discussed previously.
  • the TNSS can stimulate the appropriate nerve(s) to relieve pain with a preset pulse signal, or the user can select from variety of pulse signals, and their intensities; this might be implemented as one or more of a plurality of 'buttons' on the interface of a smartphone or actual buttons on a dedicated device. The user selects from
  • programs to deal with mild pain, moderate pain, or severe pain may provide an intermittent or a continuous pulse signal and the signal may have a timeout of a duration chosen by the user.
  • Step 1 The user can reactivate the TNSS 1401 either immediately if the pain is not completely abated, or the next time he/she feels the sensation of pain, or can maintain activation for a desired period.
  • the User's activation profile is recorded by the TNSS 1401 and shared with the Control Device 1306 or transmitted over the internet 1413.
  • the activation profile consists of a User ID, stimulation signal identifier, date and time of day, and if the user interface permits, user activity at the time of activation Historical data can be gathered and analyzed for the user's benefit.
  • Data from the Internet 1414 may be accepted by the Control Device 1406 and/or the TNSS 1401; types of data may be instructions from a healthcare professional, population data (e.g. messages from support group members), statistical analyses and trend data (relative to the individual user or across populations). This data can be passed through to the user, or cause actions to be taken (e.g. alarms, notifications, etc.).
  • types of data may be instructions from a healthcare professional, population data (e.g. messages from support group members), statistical analyses and trend data (relative to the individual user or across populations). This data can be passed through to the user, or cause actions to be taken (e.g. alarms, notifications, etc.).
  • Data 1405 can be gathered from other sensors, from other sensors, which may be located in the TNSS 1401, in the control device, and other patches, or in other devices, on a continuous basis_-or only when the TNSS 1401 is activated.
  • these data can be used to alter or modify the stimulation signals 1402 that the TNSS 1401 transmits to the user.
  • An example would be an acoustic transceiver, for example implemented in MEMS that can both transmit and receive acoustic data to create acoustic images of the structure beneath the electrodes or elsewhere in the body that may be affected by the neural stimulation. This would allow the TNSS to gather image data of the neurally stimulated region and aid in locating and identifying structures to be stimulated, providing information on which to base field or beam forming and steering functions of the TNSS 1401.
  • the TNSS 1401 is capable of steering an electric field or electric beam within the tissues using a plurality of electrodes. This includes the ability to steer the electric field or beam to activate nerves deep in the body selectively, without activating adjacent nerves or nerves nearer the surface. The user is able to control this steering directly, or to allow the device to steer stimulation to a variety of locations. Based on perception of pain relief, the user identifies and selects the pattern and location of stimulation that provides optimal pain relief. These patterns and locations are presented by the control device to the user 1410.
  • the normal activation signal 1408 to cause the TNSS 1401 to be activated comes from the user's perception that pain needs to be alleviated and action to activate the Control Device 1406 as described previously. There is a plurality of other methods that can control the source of pain in parallel or separately from this method.
  • the TNSS 1401 can send an acoustic pulse and derive an image of the stimulated region to identity the locations of deep nerves. The TNSS can then focus electrical stimulation to activate a deep nerve selectively.
  • the device may also be able to sense other effects of stimulating nerves, such as movement of contracting muscle 1404, or the electrical signals produced by contracting muscle, to assist in identifying nerves being stimulated.
  • the device may thus be able to select patterns and locations of stimulation with little or no intervention by the user.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un procédé et un dispositif de blocage de signal de douleur par stimulation électrique et sélective d'un nerf de mammifère, qui comprend les étapes consistant : à appliquer un patch dermique doté d'une électrode intégrale à proximité d'un nerf sensible tactile A-alpha ou A-beta ; à déterminer une stimulation correspondant à un nerf sensible tactile A-alpha ou A-beta, par une logique de patch dermique ; à appliquer la stimulation par les électrodes et par un stimulateur intégral avec le patch dermique pour produire un champ électrique ; et à activer de manière sélective le nerf sensible tactile A-alpha ou A-beta via le champ électrique.
PCT/US2016/018705 2015-02-21 2016-02-19 Stimulateur topique de nerf et capteur pour la gestion de la douleur WO2016134273A1 (fr)

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US12039731B2 (en) 2020-12-22 2024-07-16 Relievant Medsystems, Inc. Prediction of candidates for spinal neuromodulation

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