Patterned stimulation intensities for nerve stimulation

Abstract

This system provides a mechanism for adjusting the intensity of nerve stimulation signals over time. [Solution] The pulse generator 12 may be configured to generate a stimulus signal for stimulating the nerve tissue of an individual and to adjust parameters related to the intensity of the pulses forming a pattern of the stimulus signal over time. An electrode 14 may be connected to the pulse generator and configured to apply the stimulus signal to the nerve tissue. Each pulse of the stimulus signal can be used to recruit axonal bundles in the nerve tissue.

Description

Technical Field

[0001] This application claims the benefit of priority of PCT International Application No. PCT / US2013 / 075329, filed on December 16, 2013, the entire content of which is incorporated herein by reference for all purposes.

[0002] The present disclosure generally relates to nerve stimulation, and more particularly to systems and methods capable of adjusting the intensity of patterned pulses in nerve stimulation signals.

Background Art

[0003] By stimulating nerves with electrical signals, it is possible to activate or inhibit a part of an individual's nervous system and thereby alter and / or enhance the individual's biological functions (e.g., motor function, sensory function, autonomic function, organ function, and / or cognitive function). Conventionally, electrical signals have included trains consisting of identical electrical pulses (e.g., a constant frequency, amplitude, and pulse interval), each providing a stimulus of regular intensity. However, these trains of identical electrical pulses often do not mimic normal biological functions. For example, when responding to input to sensory nerves, normal afferent neurons can synchronously generate action potentials with non-uniform patterns along the axon bundle. When a regular train of identical pulses is applied to these afferent neurons, a corresponding regular train of synchronous action potentials is transmitted to the brain. The brain interprets this regular train of action potentials as heterogeneous, resulting in a tingling sensation or other abnormal perceptions.

Summary of the Invention

Means for Solving the Problems

[0004] This disclosure relates in general to nerve stimulation, and more particularly to systems and methods for adjusting the intensity (e.g., strength and / or timing) of patterned pulses in a nerve stimulation signal. For example, the nerve stimulation signal may include a series of pulses, and parameters related to the intensity of these patterned pulses may be changed over time. Since nerve stimulation signals with such patterned stimulation intensities (i.e., "Ψ-stimuli") can mimic normal neurological function, nerve stimulation signals can influence different biological functions, including sensory functions (e.g., perception), autonomic functions, motor functions and / or cognitive functions.

[0005] In one embodiment, the disclosure may include a system capable of adjusting the intensity (e.g., strength and / or timing) of a nerve stimulation signal over time. A pulse generator may be configured to generate a stimulation signal for application to the nerve tissue of an individual and to adjust parameters relating to the intensity of pulses forming a pattern of stimulation signals over time. Electrodes may be connected to the pulse generator and configured to apply the stimulation signal to the nerve tissue. For example, the adjustment of intensity over time may lead to the recruitment of different bundles of axons in the nerve tissue based on the adjustment of intensity.

[0006] In another aspect, the disclosure may include a method for nerve stimulation signals. Parameters relating to the intensity (e.g., strength and / or timing) of pulses of the stimulation signal are adjusted over time. Each pulse of the stimulation signal can mobilize different bundles of axons in nerve tissue. Based on the stimulation signal, a desired bodily function in an individual can be influenced. In some examples, the method may include identifying an individual that requires nerve stimulation and applying a nerve stimulation signal to that individual that requires nerve stimulation. For example, in the case of an individual with a disease, the method may include identifying the individual suffering from the disease condition.

[0007] In another embodiment, the disclosure may include a device capable of adjusting the intensity (e.g., strength and / or timing) of a nerve stimulation signal over time. The pulse generator can be designed for a feedback signal based on the nerve stimulation signal. For example, the feedback signal may be a physiological signal, a sensor signal, an input signal, etc. The pulse generator may further be designed to adjust parameters relating to the intensity of pulses of a patterned stimulation signal based on the feedback signal. [Brief explanation of the drawing]

[0008] The features described above and other features of this disclosure will become apparent to those skilled in the art by reading the following description with reference to the accompanying drawings. [Figure 1] Figure 1 is a block diagram showing a system according to one aspect of the present disclosure that can adjust the intensity of nerve stimulation signals. [Figure 2] Figure 2 is a block diagram showing a receiver that may be part of the system in Figure 1 to receive a feedback signal that can be used to adjust the intensity of nerve stimulation signals. [Figure 3] Figure 3 is a graph showing an example of adjusting the intensity of nerve stimulation signals that can be performed using the system shown in Figure 1. [Figure 4] Figure 4 is an illustrative diagram of an electrode that may be part of the system shown in Figure 1. [Figure 5] Figure 5 is an illustrative diagram of an electrode that may be part of the system shown in Figure 1. [Figure 6] Figure 6 is a process flowchart illustrating a method for nerve stimulation according to another aspect of the present disclosure. [Figure 7] Figure 7 is a process flowchart illustrating a method for adjusting the signal intensity used for nerve stimulation in the method shown in Figure 6. [Figure 8] Figure 8 is a process flowchart illustrating a method for influencing desired bodily functions through nerve stimulation using the method shown in Figure 6. [Modes for carrying out the invention]

[0009] I. Definition In the context of this disclosure, the singular forms “a,” “an,” and “the” may also include the plural form unless the context clearly indicates otherwise. The terms “comprises” and / or “comprising,” as used herein, may indicate the presence of the described features, processes, actions, elements, and / or components, but do not exclude the presence or addition of one or more features, processes, actions, elements, components, and / or groups. As used herein, the terms “and / or” may include any combination of one or more of the listed related items. Also, while terms such as “first,” “second,” etc., may be used herein to describe various elements, these elements should not be limited by these terms, and these terms are used merely to distinguish one element from another. Thus, the “first” element described later may also be called the “second” element without deviating from the teachings of this disclosure. The order of actions (or processes) is not limited to the order presented in the claims or drawings unless it is specifically indicated otherwise.

[0010] As used herein, the term “neural stimulation” may mean the therapeutic activation or suppression of at least a portion of an individual’s nervous system in order to replace, restore, and / or enhance biological function by a stimulating signal. In some examples, the stimulating signal may be applied to the nerve tissue of an individual by one or more electrodes.

[0011] As used herein, the term “stimulating signal” can mean a signal that can activate or inhibit a part of an individual’s nervous system in order to replace, restore, and / or enhance the biological functions of that individual. For example, a stimulating signal may include one or more of the following: electrical signals, magnetic signals, optical signals, optogenetic signals, chemical signals, etc. In some examples, a stimulating signal may include a series of pulses.

[0012] As used herein, the term “pulse” may mean a non-sinusoidal waveform of current and / or voltage. In some examples, a pulse may be charge-balanced. In other examples, multiple pulses can be arranged into one or more pulse patterns. Examples of pulse shapes include square, rectangular, sawtooth, logarithmic, and exponential.

[0013] As used herein, the term “biological function” may mean processes occurring within an individual’s body that are controlled by the nervous system. Examples of biological functions include motor functions, sensory functions, autonomic functions, organ functions, and cognitive functions. The terms “biological function” and “physical function” may be used interchangeably herein.

[0014] As used herein, the term “electrode” can mean one or more conductors that come into contact with a part of an individual’s body to transmit a stimulus signal. In some examples, individual conductors can mean “contacts.” For example, electrodes may be multi-contact electrodes and / or multiple single-contact electrodes.

[0015] As used herein, “nerve tissue” may mean a bundle of axons capable of responding to a stimulus and transmitting impulses to various organs or tissues within the body that trigger a response to the stimulus. Examples of nerve tissue include bundles of axons in the central nervous system (e.g., axons in the brain and / or spinal cord) or bundles of axons in the peripheral nervous system (e.g., axons of motor nerves, axons of autonomic nerves and / or axons of sensory nerves). The terms “axon” and “nerve fiber” may be used interchangeably herein.

[0016] As used herein, the term “patterned stimulation intensity” (or “Ψ-stimulus”) may mean variations in one or more stimulation parameters relating to the intensity of a patterned pulse in a nerve stimulation signal. For example, since variations in one or more stimulation parameters may lead to the recruitment of different bundles of axons within nerve tissue, “patterned intensity stimulation” may mean bundle-based encoding of nerve tissue. The terms “patterned intensity adjustment” and “patterned stimulation intensity” may be used interchangeably herein.

[0017] As used herein, the term “intensity” of a stimulus signal may mean the strength and / or timing of the stimulus signal. In some examples, intensity may correspond to the number of nerve fibers recruited by a single pulse and / or a pattern of pulses of the stimulus signal.

[0018] As used herein, the term "stimulation parameter" can mean the parameter of one pulse and / or a pattern of pulses related to the intensity of a stimulation signal. Examples of stimulation parameters include maximum value, pulse width, pulse interval, pulse shape (e.g., square, rectangular, exponential, logarithmic, sawtooth, etc.), parameters affecting the pulse shape, recharge phase amplitude, recharge delay, and the like. The terms "stimulation parameter", "intensity parameter", and "pulse parameter" can be used interchangeably herein.

[0019] As used herein, the term "individual" can mean a warm-blooded organism including, but not limited to, humans, pigs, rats, mice, dogs, cats, goats, sheep, horses, monkeys, apes, rabbits, cows, etc. The terms "individual", "subject", "patient", and "user" can be used interchangeably herein unless otherwise specified. II. Summary

[0020] The present disclosure generally relates to nerve stimulation, and particularly to systems and methods capable of adjusting the intensity (e.g., strength and / or timing) of pulsed patterns in nerve stimulation signals. For example, it can generate a stimulation signal for application to the nerve tissue of an individual and can adjust parameters related to the intensity of the pulsed patterns of the stimulation signal over time. When the stimulation signal is applied to the nerve tissue, bundles of axons in the nerve tissue can be mobilized for each pulse of the stimulation signal.

[0021] Neural stimulation at a patterned stimulation intensity (i.e., “Ψ-stimulation”) in the peripheral nervous system and / or central nervous system can affect different biological functions including sensory functions (e.g., perception), autonomic functions, motor functions, organ functions and / or cognitive functions. For example, neural stimulation can be used to affect biological functions in a normal healthy individual, an individual who has lost one or more limbs, a paralyzed individual or a diseased individual (e.g., an individual with autonomic neuropathy, motor disorder and / or sensory disorder, etc.). In one example, the biological function may include sensory recovery in an individual who has lost one or more limbs or a paralyzed individual. Sensory recovery may include providing a “virtual” sense in place of the lost biological sense. In other examples, the biological function may include providing an artificial sense to a healthy individual for touch-based virtual reality, user interface, clinical diagnosis, mechanical diagnosis, robot control and / or telepresence by stimulating the median nerve, ulnar nerve and / or radial nerve.

[0022] Other examples of biological functions include pain regulation, such as regulating an individual's pain perception. In yet another example, a biological function may include the restoration or enhancement of taste, smell, hearing, sight, or touch. In yet another example, a biological function may include the regulation of swallowing. In yet another example, a biological function may include the regulation of gastric reflux. In yet another example, a biological function may include the regulation of blood pressure, appetite, etc. In yet another example, a biological function may include the restoration or enhancement of sexual sensation. In yet another example, a biological function may include the regulation of the urogenital system, such as the reduction of incontinence, the regulation of bowel movements, or the regulation of other bladder functions. In yet another example, a biological function may include the improvement of milk secretion for lactation. In yet another example, a biological function is the restoration of sensation of removed or lost tissue in an individual. In yet another example, in an individual who has undergone a mastectomy, the sensation of removed chest tissue can be restored. In yet another example, a biological function may include the regulation of motor abnormalities. For different biological functions, electrodes can be placed in different areas of the individual's body, and different bundles of axons within the nerve tissue can be recruited by patterned intensity adjustments of the stimulation signals. TEAS.system

[0023] One aspect of this disclosure may include a system capable of adjusting the intensity of a nerve stimulation signal. While not theoretically bound, it is conceivable that by adjusting the intensity of a nerve stimulation signal, the signal can mimic the normal neurological function of an individual more closely than conventional stimulation, through a regular sequence of identical pulses. When applying a stimulation signal to nerve tissue, such adjustment allows each pulse of the stimulation signal to recruit different bundles of axons in the nerve tissue.

[0024] Figure 1 shows an example of a system 10 that can adjust the intensity (e.g., strength and / or timing) of a nerve stimulation signal according to one aspect of the present disclosure. The system 10 may include a pulse generator 12 for generating and adjusting a stimulation signal (SS), and electrodes 14 for applying the stimulation signal (SS) to the nerve tissue of an individual. In some examples, the stimulation signal (SS) may be a time-variable electrical signal. In some examples, the pulse generator 12 may employ a patterned stimulation intensity (i.e., a "Ψ-stimulus") to vary one or more parameters relating to the intensity of the stimulation signal (SS). As described above, nerve stimulation using a patterned stimulation intensity can activate and / or suppress different biological functions, including sensory functions (e.g., perception), autonomic functions, motor functions, organ functions and / or cognitive functions, in a normal individual, an individual that has lost one or more limbs, an individual that is paralyzed, an individual that is diseased, etc.

[0025] The pulse generator 12 may be a device configured to generate a stimulus signal (SS). In some examples, the pulse generator 12 may be configured to adjust parameters relating to the intensity of pulses that form a pattern of the stimulus signal. For example, the pulse generator 12 can adjust the intensity parameters over time. In other examples, the pulse generator 12 can generate and / or adjust the stimulus signal (SS) based on a desired physical function. In another example shown in Figure 2, the pulse generator 12 may be configured to generate and / or adjust the stimulus signal (SS) based on input relating to a desired physical function.

[0026] In the example shown in Figure 2, the pulse generator 12 can be connected to the receiver 22. In some examples, the pulse generator 12 and the receiver 22 may be implemented as components of a single device. In other examples, the pulse generator 12 and the receiver 22 may each be implemented as separate devices connected by wired and / or wireless connections to facilitate communication between the pulse generator 12 and the receiver 22.

[0027] One or more functions of the pulse generator 12 and / or receiver 22 may be executed by instructions from a computer program. These computer program instructions may be provided in the processor of a general-purpose computer, a dedicated computer, and / or other programmable data processing device, and a machine may be manufactured such that the instructions executed by the processor of that computer and / or other programmable data processing device form a mechanism for executing the functions of the pulse generator 12 and / or receiver 22.

[0028] It is also possible to store these computer program instructions in a non-transient computer-readable memory, and to cause that memory to function in a special way such that a product is manufactured that includes instructions for the pulse generator 12 and / or receiver 22 to perform the functions of the pulse generator 12 and / or receiver 22 by the instructions stored in the non-transient computer-readable memory.

[0029] Alternatively, instructions for a computer program may be loaded into a computer or other programmable data processing device to generate a process that the computer executes through a series of operational steps on that device, thereby providing steps for the instructions executed on that device to perform the functions of the components specifically shown in the block diagram and its accompanying description.

[0030] Therefore, at least a portion of the pulse generator 12 and / or receiver 22 can be embodied in hardware and / or software (including firmware, resident software, microcode, etc.). Furthermore, embodiments of the system 10 may take the form of a computer program product on a computer-enabled recording medium or computer-readable recording medium having computer-enabled program code or computer-readable program code that is implemented by or in connection with an instruction execution system. The computer-enabled medium or computer-readable medium may be any non-transient medium that is not transient signal medium and may contain or store a program that is used by or in connection with an instruction or execution of a system, apparatus, or device. The computer-enabled medium or computer-readable medium may be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device. More specific examples (a non-exclusive list) of computer-readable media include portable computer diskettes, random-access memory, read-only memory, erasable and programmable read-only memory (or flash memory), and portable compact disk read-only memory.

[0031] Such functions of the receiver 22 may include receiving an input signal (FS) and transmitting data relating to the input signal (PFS) to the pulse generator 12. In some examples, the receiver 22 may be configured to perform signal processing on the input signal (FS). For example, the signal processing performed by the receiver 22 may convert the input signal (FS) into data relating to the input signal (PFS). The data relating to the input signal (PFS) may be transmitted to the pulse generator 12.

[0032] The pulse generator 12 may be configured to generate and / or adjust a stimulation signal (SS) based on data (FS) relating to an input signal. For example, the input signal (FS) may include user input, feedback signal input from nerve tissue or other tissue, sensor signal input, time input, etc. Another example is that the input signal may include input relating to a stimulation paradigm that defines an adjustment pattern or envelope that can be adopted by the pulse generator 12.

[0033] In either system 10 in Figure 1 or system 20 in Figure 2, the stimulus signal (SS) generated by the pulse generator 12 may include multiple pulses. In some examples, the multiple pulses may be charge-balanced (cathodic-first and / or anodic-first). In other examples, the patterned multiple pulses may be charge-balanced even if the individual pulses are not charge-balanced. In yet another example, the multiple pulses do not need to be charge-balanced, but they can be used for a sufficiently short time so that the electrochemical reaction products are not generated in a magnitude that would cause damage to the surrounding tissue or electrode 14.

[0034] The pulse generator 12 can adjust the stimulus signal (SS) by adjusting one or more pulse parameters relating to the intensity of the stimulus signal (SS). Adjusting one or more pulse parameters relating to the intensity of the stimulus signal (SS) allows different bundles of axons to be recruited using each pulse. For example, the pulse generator 12 can change the intensity pulse parameters for each pulse. In other examples, the pulse generator 12 can change the intensity pulse parameters for multiple pulses based on a stimulus paradigm that defines an adjustment pattern or adjustment envelope. The adjustment pattern or adjustment envelope may have any shape that represents a time-variable variation of one or more pulse parameters relating to the intensity of the stimulus signal (SS). Examples of shapes for the adjustment pattern or adjustment envelope include sine, triangle, trapezoid, etc. In some examples, a single intensity pulse parameter can be adjusted by the pulse generator 12. In other examples, different intensity pulse parameters can be adjusted by the pulse generator 12 at different time points. In yet another example, multiple different intensity pulse parameters can be adjusted by the pulse generator 12 simultaneously (or substantially simultaneously).

[0035] One or more stimulus parameters may be any parameters of the pulse and / or patterned pulses relating to the intensity of the stimulus signal. Examples of intensity stimulus parameters include maximum value, pulse width, pulse interval, pulse shape, parameters affecting pulse shape, recharge phase amplitude, and recharge delay. Other examples of intensity parameters include parameters relating to the regulating envelope (e.g., shape, frequency, amplitude).

[0036] Figure 3 shows examples of different adjustments that can be performed by the pulse generator 12 for a series of pulses, as graphs of the temporal characteristics of the pulse train (e.g., pulse intensity). The graphs in Figure 3 are illustrative schematic diagrams showing different parameters of the adjustable stimulus signal (SS). In Figure 3, the baseline signal is shown at 32. At 34, the maximum value of the baseline signal may be changed. At 36, the pulse interval may be changed. At 38, the pulse interval and maximum value / shape may be changed in combination. In elements 34 and 36, a single parameter is changed for a group of pulses. At 38, a parameter (pulse interval) is changed for a group of pulses, and a parameter (maximum value) is changed for individual pulses. Further adjustments may be made to other parameters not shown in Figure 3 (e.g., pulse width, parameters affecting pulse shape, recharge phase amplitude, recharge delay, parameters relating to the adjustment envelope (e.g., shape, frequency, amplitude), and parameters of pulses and / or patterned pulses relating to the intensity of the stimulus signal).

[0037] Referring again to Figures 1 and 2, the electrode 14 can be connected to the pulse generator 12 to receive stimulation signals (SS) transmitted from the pulse generator. The electrode 14 may interface with the nerve tissue of an individual to transmit stimulation signals (SS) to the nerve tissue and affect a desired biological function. The electrode 14 can be placed percutaneously, subcutaneously, or directly on the nerve tissue to be stimulated. In some examples, the nerve tissue that the electrode 14 can interface with may include parts of the central nervous system (e.g., deep brain stimulation, spinal cord stimulation, etc.). For example, deep brain stimulation can be used to treat movement disorders such as essential tremor or Parkinson's disease. In other examples, deep brain stimulation and / or spinal cord stimulation can be used for pain management. In yet another example, the nerve tissue that the electrode can interface with may include parts of the peripheral nervous system (e.g., nerves (e.g., afferent nerves, efferent nerves and / or autonomic nerves) and / or ganglia).

[0038] In some examples, electrode 14 may include a set of multiple contacts, each containing N electrode contacts (where N is a positive integer greater than or equal to 2). For example, pulse generator 12 can adjust the timing and intensity of each pulse in the stimulus signal (SS) between the multiple contacts to change the electric field propagated by electrode 14 into the nerve tissue. In some examples, electrode 14 (e.g., an electrode array) may include a plurality of single-contact electrodes 42a-d, as schematically shown in Figure 4. For example, there may be multiple electrodes between or within a fiber bundle. In other examples, the electrodes may be located within the brain and / or spinal cord. In other examples, electrode 14 may include a multi-contact electrode (e.g., a nerve cuff electrode, a spiral electrode) with a plurality of contacts 42m-i, as schematically shown in Figure 5.

[0039] As described above, the pulse generator 12's pulse signal (SS) with patterned stimulation intensities can affect different biological functions, including sensory functions (e.g., perception), autonomic functions, motor functions, organ functions, and / or cognitive functions. In one example, the biological function may include sensory recovery in an individual who has lost one or more limbs or is paralyzed. In another example, the biological function may include pain regulation. In yet another example, the biological function may include taste recovery. In yet another example, the biological function may include swallowing regulation. In yet another example, the biological function may include gastric reflux regulation. In yet another example, the biological function may include blood pressure regulation, appetite regulation, etc. In yet another example, the biological function may include hearing, vision recovery, etc. In yet another example, the biological function may include sexual sensation recovery or enhancement of sexual sensation. In yet another example, the biological function may include urogenital regulation, such as incontinence reduction or defecation regulation. In yet another example, sensation can be restored in individuals who have undergone a mastectomy, specifically in the removed chest tissue. In yet another example, the biological function may include the regulation of motor abnormalities. For different biological functions, electrodes can be placed in different areas of the individual's body, and patterned intensity adjustments of stimulus signals can be linked to the recruitment of different bundles of axons within nerve tissue. IV. Method

[0040] Another aspect of this disclosure may include methods for adjusting the intensity (e.g., strength and / or timing) of a nerve stimulation signal. Method 60, an example of nerve stimulation for influencing a desired bodily function, is shown in Figure 6. Method 70, another example of adjusting the intensity of a signal used for nerve stimulation, is shown in Figure 7. Method 80, yet another example of nerve stimulation for influencing a desired bodily function, is shown in Figure 8. In some examples, this method may involve identifying an individual in need of nerve stimulation and applying the nerve stimulation signal to that individual in need. For example, in the case of an individual with a disease, this method may include identifying the individual suffering from the disease.

[0041] Methods 60–80 in Figures 6–8 are illustrated as process flow diagrams in example flowcharts. For simplicity, methods 60–80 are illustrated and described as being performed serially. However, it will be understood and obvious that this disclosure is not limited to the illustrated order, as some steps may occur in a different order and / or simultaneously with other steps illustrated and described herein. Furthermore, not all illustrated embodiments may be required to perform methods 60–80.

[0042] One or more blocks in each flowchart diagram, and combinations of blocks in a block flowchart diagram, may be executed by computer program instructions. These computer program instructions may be provided in the processor of a general-purpose computer, a dedicated computer, and / or other programmable data processing device, and the machine may be manufactured such that the instructions executed by the processor of that computer and / or other programmable data processing device form a mechanism for performing the functions of the pulse generator 12 and / or receiver 22. In other words, the process / action may be executed by a system including a processor that has access to computer-executable instructions stored in non-transient memory.

[0043] Methods 60-80 of this disclosure may be embodied in hardware and / or software (including firmware, resident software, microcode, etc.). Furthermore, aspects of this disclosure may take the form of a computer program product on a computer-available recording medium or computer-readable recording medium having computer-available program code or computer-readable program code, which is embodied by or in the form of a medium used with an instruction execution system. The computer-available medium or computer-readable medium may be any non-transient medium capable of containing or storing a program used by or in conjunction with an instruction or execution of a system, apparatus, or device.

[0044] Referring to Figure 6, one aspect of the present disclosure may include a method 60 for stimulating nerves to affect bodily functions. In 62, a stimulation signal (e.g., SS) can be generated (e.g., by a pulse generator 12) for application to the nerve tissue of an individual. The nerve tissue may include central nervous system tissue and / or peripheral nervous system tissue (motor nerves, sensory nerves and / or autonomic nerves). The stimulation signal may consist of parameters formed to suit a desired biological function. For example, the stimulation signal may include multiple pulses that can be arranged into a pattern. As described above, nerve stimulation is applicable to normal individuals, individuals that have lost one or more limbs, paralyzed individuals, diseased individuals, etc. For example, the stimulation signal may include multiple pulses (e.g., arranged into a controlled pattern or envelope).

[0045] In 64, the intensity parameters of the patterned pulses in the stimulus signal may be modified (for example, by the pulse generator 12). This modification may be based on a desired bodily function. For example, one or more parameters relating to the intensity of the stimulus signal can be adjusted. When one or more pulse parameters relating to the intensity of the stimulus signal are adjusted, different bundles of axons can be recruited with each pulse. For example, the intensity parameters can be changed on a pulse-by pulse basis. In another example, the pulse parameters relating to the intensity can be changed for multiple pulses based on an adjustment pattern or adjustment envelope (for example, of any shape representing a time-variable variation of one or more pulse parameters relating to the intensity of the stimulus signal). In some examples, a single intensity parameter is adjustable. In other examples, different intensity parameters can be adjusted at different time points. In yet another example, multiple different pulse parameters relating to the intensity can be adjusted simultaneously (or substantially simultaneously) by the pulse generator 12. One or more stimulus parameters may be any parameters of the pulses and / or patterned pulses relating to the intensity of the stimulus signal. Examples of stimulation parameters related to intensity include maximum value, pulse width, pulse interval, pulse shape, parameters affecting pulse shape, recharge phase amplitude, and recharge delay.

[0046] In 66, a tuned stimulation signal can be applied to the nerve tissue of an individual (by activating one or more contacts of electrode 14) to affect bodily functions. As described above, electrodes can be placed percutaneously, subcutaneously, or directly on the nerve tissue to be stimulated. In some examples, the nerve tissue that electrodes can interface with may include parts of the central nervous system (e.g., deep brain stimulation, spinal cord stimulation, etc.). For example, deep brain stimulation can be used to treat movement disorders such as essential tremor or Parkinson's disease. In other examples, deep brain stimulation and / or spinal cord stimulation can be used for pain management. In other examples, the nerve tissue that electrodes can interface with may include parts of the peripheral nervous system (e.g., nerves (e.g., afferent nerves, efferent nerves, and / or autonomic nerves) and / or ganglia). For example, bodily functions may include sensory functions (e.g., perception), autonomic functions, motor functions, organ functions, and / or cognitive functions. In one example, biological functions may include sensory recovery in an individual who has lost one or more limbs. In other examples, the biological function may include pain regulation. In yet another example, the biological function may include taste restoration. In yet another example, the biological function may include swallowing regulation. In yet another example, the biological function may include gastric reflux regulation. In yet another example, the biological function may include blood pressure regulation, appetite regulation, etc. In yet another example, the biological function may include hearing, vision, etc. In yet another example, the biological function may include sexual sensation restoration or enhancement of sexual sensation. In yet another example, the biological function may include genitourinary regulation such as incontinence reduction and bowel movement regulation. In yet another example, the biological function may include motor function regulation.

[0047] For different biological functions, electrodes may be placed in different areas of the individual's body, and patterned intensity adjustments of the stimulation signal may be used to recruit different bundles of axons within the nerve tissue. Electrodes can be placed percutaneously, subcutaneously, or directly on the nerve tissue being stimulated. For example, in the case of nerve stimulation, electrodes can be placed in the patient's skin (transcutaneous electronervous stimulation).

[0048] Figure 7 shows an example of a method 70 for adjusting the intensity of a signal usable for nerve stimulation. In 72, a stimulation signal (e.g., SS) can be applied to the nerve tissue of an individual (e.g., by electrode 14). In some examples, the stimulation signal may be a time-variable electrical signal. For example, the stimulation signal may consist of multiple pulses. Each pulse may have the same and / or different shapes (e.g., rectangle, triangle, trapezoid, sine wave, etc.). In some examples, the multiple pulses may be charge-balanced (e.g., individually charge-balanced, or the patterned pulses may be charge-balanced). In other examples, the multiple pulses may be applied for a short period of time, in which case the multiple pulses do not need to be charge-balanced.

[0049] In 74, a feedback signal (e.g., FS) in response to the application of a stimulus signal can be received (e.g., by receiver 22). For example, the feedback signal may include user input, feedback signal input from nerve tissue or other tissue, sensor signal input, time input, etc. The feedback signal may also include, for example, inputs regarding stimulus parameters that define the adjustment pattern or envelope and / or inputs regarding the stimulus paradigm. In some examples, signal processing may be performed on the feedback signal (e.g., by receiver 22 and / or pulse generator 12). As an example, signal processing may convert the input signal into data (e.g., PFS) regarding an input signal that can be applied to adjust the stimulus signal.

[0050] In 76, the intensity parameters of the stimulus signal can be adjusted based on a feedback signal (for example, by the pulse generator 12). In other examples, two or more intensity parameters of the stimulus signal may be changed based on the stimulus signal. Adjusting one or more intensity parameters of the stimulus signal with respect to intensity allows different bundles of axons to be recruited using each pulse. For example, the intensity parameter for each pulse may be changed based on a feedback signal. Another example is that the intensity parameters for multiple pulses may be changed based on a feedback signal according to a stimulus paradigm that defines an adjustment pattern or adjustment envelope (for example, an arbitrary time-variable shape such as a sine wave, triangle, or trapezoid). In some examples, a single intensity parameter with respect to intensity may be adjusted, while in other examples, different intensity parameters with respect to intensity may be adjusted at different times and / or simultaneously (or substantially simultaneously). Examples of adjustable intensity parameters include maximum value, pulse width, pulse interval, pulse shape, parameters affecting pulse shape, recharge phase amplitude, and recharge delay. Other examples of intensity parameters include parameters related to the adjustment envelope (for example, shape, frequency, amplitude, etc.).

[0051] Figure 8 shows an example of a method 80 for influencing a desired physical function using nerve stimulation. The nerve stimulation may include a patterned stimulation intensity (i.e., "Ψ-stimulus") to recruit a bundle of axons to influence the desired physical function. In 82, a stimulation signal (e.g., SS) whose intensity is adjusted over time (e.g., by a pulse generator 12) can be applied to the nerve tissue of the individual (e.g., by an electrode 14). For example, the intensity may be adjusted over time based on a feedback signal. As mentioned above, for example, the feedback signal may include a user input, a feedback signal input from nerve tissue or other tissue, a sensor signal input, a time input, etc. As mentioned above, the nerve stimulation can be applied to a normal individual, an individual that has lost one or more limbs, an individual that is paralyzed, an individual that is diseased, etc.

[0052] In 84, each pulse of the stimulus signal can be used to recruit different bundles of axons in nerve tissue. For example, the patterned stimulus intensity can be adjusted in terms of timing and / or strength to change the electric field propagated from each pulse to the nerve tissue. In 88, based on the recruited bundle of axons, a desired bodily function can be influenced. For example, the bodily function may be a sensory function (e.g., perception), an autonomic function, a motor function, an organ function, and / or a cognitive function. In some examples, the patterned stimulus intensity may be specific in order to influence the desired bodily function. V. Additional devices, systems and methods

[0053] Neuronal stimulation using patterned stimulus intensities (i.e., "Ψ-stimuli") (for example, by the systems and methods described above) can be applied to the peripheral and / or central nervous systems of normal, healthy individuals, individuals who have lost one or more limbs, paralyzed individuals, or individuals with disorders such as autonomic, motor, and / or sensory impairments affecting specific biological functions. Patterned stimulus intensities allow the signal to mimic actual biological signals and can elicit biological functions more naturally than other types of stimulation.

[0054] One application of neural stimulation with patterned stimulus intensities is the ability to give an individual "virtual" sensations. For example, stimulating the median nerve, ulnar nerve, and / or radial nerve can provide artificial sensations. In another example, virtual sensations enable virtual reality, user interfaces (with computing devices, for example), and telepresence, which are made possible by sensory nerves (e.g., touch, sight, hearing, taste, smell).

[0055] Other examples of virtual sensations may include medical applications such as clinicians physically diagnosing patients remotely. Other uses of virtual sensations may include enhancing social media by enabling virtual contact in gaming and / or allowing individuals to virtually contact other individuals (for example, by allowing an individual to perceive the sensation of holding another individual's hand).

[0056] Another example involves using an individual's fingers to enable perceived sensations that the individual would otherwise be unable to experience physically or safely. Such a system allows a carpenter to feel tacks or wires on a wall using their fingers, without traditional tools. Another example allows an obstetrician to feel a fetal heartbeat while examining the uterus. Yet another example allows a clinician to "feel" ultrasound information indicating irregular tissue clumps in the chest, abdomen, or other parts of the body. Current detection tools translate physical information into visible information that the user interprets. Using patterned intensity adjustments, clinicians may be able to better interpret and diagnose patients by using tactile sensation, or by relying solely on visual inspection, or by using tactile sensation in addition to visual inspection.

[0057] Another use case for virtual sensations is robotic control, where feedback from a robotic system (such as a drone pilot or robotic aircraft) is returned to the operator, allowing the pilot to feel what is happening inside or on the aircraft, thereby improving the control and operation of the robotic system.

[0058] Other uses of this disclosure may include situations where it is not safe to actually (physically) experience a sensation. For example, a mechanic may be able to diagnose engine performance by "feeling" vibration or temperature information from sensors inside the engine. While the pressures and forces inside the engine would far exceed what can be safely felt, this disclosure allows for replacing a certain percentage of the data from sensors with tactile sensations.

[0059] From the above description, a person skilled in the art will be able to understand the improvements, changes, and modifications. Such improvements, changes, and modifications are within the scope of the skills of a person skilled in the art and are intended to be included in the attached claims.

Claims

1. A pulse generator configured to generate a stimulus signal for application to the nerve tissue of an individual, and to adjust over time parameters relating to the intensity of the pulses forming a pattern of the stimulus signal, A system comprising: an electrode connected to the pulse generator and configured to apply the stimulation signal to the nerve tissue.

2. The system according to claim 1, wherein the pulses forming the pattern include a plurality of pulses, and the intensity parameter is changed for each of the plurality of pulses.

3. The system according to claim 1, wherein the parameter relating to the intensity is modified based on at least one of the input from the nerve tissue, the input from the sensor, and the time input.

4. The system according to claim 1, wherein the stimulus signal is configured to mobilize different bundles of axons using each pulse of the stimulus signal.

5. The electrode includes a plurality of contacts, The system according to claim 1, wherein the timing and intensity of each pulse in the stimulus signal are adjusted between the plurality of contacts in order to change the electric field propagated to the nerve tissue by the electrode.

6. A stimulus signal in which parameters related to pulse intensity are adjusted over time is applied to the nerve tissue of an individual. Each pulse of the aforementioned stimulus signal is used to recruit different bundles of axons in the nerve tissue. A method comprising influencing a desired bodily function in the individual based on the aforementioned stimulus signal.

7. The method according to claim 6, wherein the parameter includes the shape of the pulse of the stimulus signal.

8. The method according to claim 6, wherein the parameter includes at least one of pulse amplitude, recharge phase amplitude, recharge delay, and pulse shape.

9. The method according to claim 6, further comprising individually adjusting at least two parameters for each pulse in order to affect the bundle of axons affected by each pulse.

10. The method according to claim 6, wherein the desired physical function includes adjustment of perception with respect to a part of the individual's body.

11. The method according to claim 6, wherein the desired physical function includes adjusting the autonomous function of the individual.

12. The method according to claim 6, wherein the desired physical function includes adjusting the motor function of the individual.

13. The method according to claim 6, wherein the individual is at least one of a healthy individual, an individual that has lost one or more limbs, or an individual that is paralyzed.

14. The method according to claim 6, further comprising, based on the patterned intensity adjustment, communicating with the nerve tissue of the individual to activate specific contacts of an electrode comprising a plurality of contacts.

15. The method according to claim 14, wherein the patterned intensity adjustment adjusts the timing and intensity of each pulse in the stimulation signal between the plurality of contacts in order to change the electric field delivered to the nerve tissue by the electrode.

16. A pulse generator configured to generate a stimulus signal for application to the nerve tissue of an individual, The system includes a receiver configured to receive a feedback signal in response to the application of the nerve stimulation signal, The pulse generator is configured to adjust parameters relating to the intensity of pulses forming a pattern of the stimulus signal based on the feedback signal.

17. The aforementioned feedback signal is a physiological feedback signal, according to the device 16.

18. The apparatus according to claim 17, wherein the feedback signal is based on the application of the stimulation signal to the nerve tissue of the individual.

19. The apparatus according to claim 16, wherein the feedback signal includes a signal from a sensor.

20. The apparatus according to claim 16, wherein the pulse generator is configured to transmit the stimulation signal to an electrode for application to the nerve tissue.

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