Patent Description:
Neuromodulation, also referred to as neurostimulation, has been proposed as a therapy for a number of conditions. Examples include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES).

Implantable neuromodulation systems have been applied to deliver SCS therapy. An implantable neuromodulation system may include an implantable neuromodulator, which may also referred to as an implantable pulse generator (IPG), and one or more implantable leads each including one or more electrodes. The implantable neuromodulator delivers neuromodulation energy through one or more electrodes placed on or near a target site in the nervous system.

An external programming device is commonly used to program the implantable neurostimulator with stimulation parameters controlling the delivery of the neurostimulation energy. Modulation parameters may comprise electrode combinations, which define the electrodes that are activated as anodes (positive), cathodes (negative), and turned off (zero), percentage of modulation energy assigned to each electrode (fractionalized electrode configurations), and electrical pulse parameters, which define the pulse amplitude (measured in milliamps or volts depending on whether the pulse generator supplies constant current or constant voltage to the electrode array), pulse width (measured in microseconds), pulse rate (measured in pulses per second), and burst rate (measured as the modulation on duration X and modulation off duration Y). The values for these parameters may be customized to a patient. The modulation parameters may be configured as a neuromodulation program capable of being implemented by the neuromodulator, and the neurostimulator may be programmed with more than one program. In order to find a program that provides an effectively provides a therapy (e.g., pain relief) with negligible side effects, the patient or clinician may implement different programs within the neuromodulator. However, further optimization of the SCS therapy for the patient is desirable. <CIT> discloses techniques for adjusting sub-perception stimulation applied to a patient by an Implantable Pulse Generator (IPG). Adjustment can occur through use of one or more modulation functions associated with a stimulation modulation algorithm that adjusts the total charge provided by the stimulation to the patient as a function of time. The modulation function and algorithm can adjust the charge either by duty cycling the stimulation, or by adjusting the sub-perception stimulation parameters, and such adjustment can occur in the IPG or an external device. The stimulation modulation algorithm may use one or more models when adjusting the stimulation parameters to keep them at optimal values for sub- perception stimulation while simultaneous adjusting the charge stimulation provided as prescribed by the modulation function. <CIT> discloses techniques for controlling therapy delivery based on the relative orientation and/or motion of a device accelerometer and a lead accelerometer. In one embodiment, a therapy system includes an electrical stimulator and a lead.

The subject-matter of the present invention is defined by the features of the independent claim.

Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims.

The following detailed description of the present subject matter refers to the accompanying drawings which show, by way of illustration, specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. Other embodiments may be utilized and structural, logical, and electrical changes may be made without departing from the scope of the present subject matter. References to "an", "one", or "various" embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined only by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

<FIG> illustrates, by way of example, an embodiment of a neuromodulation system. The illustrated neuromodulation system <NUM> includes electrodes <NUM>, a neuromodulation device <NUM> and a programming system such as a programming device <NUM>, which may be a clinician programmer. The programming system may include multiple devices that may be configured to communicate with each other (e.g., remote control, clinician programmer, and mobile electronic devices such as a phone, tablet, pad and the like). The electrodes <NUM> are configured to be placed on or near one or more neural targets in a patient. The neuromodulation device <NUM> is configured to be electrically connected to electrodes <NUM> and deliver neuromodulation energy, such as in the form of electrical pulses, to the one or more neural targets though electrodes <NUM>. The system may also include sensing circuitry to sense a physiological signal, which may but does not necessarily form a part of neuromodulation device <NUM>. The delivery of the neuromodulation is controlled using a plurality of modulation parameters that may specify the electrical waveform (e.g., pulses or pulse patterns or other waveform shapes) and a selection of electrodes through which the electrical waveform is delivered. In various embodiments, at least some parameters of the plurality of modulation parameters are programmable by a user, such as a physician or other caregiver. The programming device <NUM> enables the user to access the user-programmable parameters, and may also provide the user with data indicative of the sensed physiological signal or feature(s) of the sensed physiological signal. In various embodiments, the programming device <NUM> is configured to be communicatively coupled to modulation device via a wired or wireless link. In various embodiments, the programming device <NUM> includes a user interface <NUM> such as a graphical user interface (GUI) that allows the user to set and/or adjust values of the user-programmable modulation parameters. The user interface <NUM> may also allow the user to view the data indicative of the sensed physiological signal or feature(s) of the sensed physiological signal and may allow the user to interact with that data. The neuromodulation device <NUM>, the programming device <NUM> and other devices or system may collect data that may be used by the neuromodulation system <NUM>. For example, the user interface <NUM> may be used to allow the user to answer healthcare-related questions.

<FIG> illustrates, by way of example and not limitation, the neuromodulation system of <FIG> implemented in a spinal cord stimulation (SCS) system. The illustrated neuromodulation system <NUM> includes an external system <NUM> that may include at least one programming device. The illustrated external system <NUM> may include a clinician programmer <NUM> configured for use by a clinician to communicate with and program the neuromodulator, and a remote control device <NUM> configured for use by the patient to communicate with and program the neuromodulator. For example, the remote control device <NUM> may allow the patient to turn a therapy on and off and/or may allow the patient to adjust patient-programmable parameter(s) of the plurality of modulation parameters. <FIG> illustrates a neuromodulation device <NUM> as an implantable device, although a neuromodulation device <NUM> may be an external device such as a wearable device. The external system <NUM> may include a network of computers, including computer(s) remotely located from the neuromodulation device <NUM> that are capable of communicating via one or more communication networks with the programmer <NUM> and/or the remote control device <NUM>. The remotely located computer(s) and the neuromodulation device <NUM> may be configured to communicate with each other via another external device such as the programmer <NUM> or the remote control device <NUM>. The remote control device <NUM> and/or the programmer <NUM> may allow a user (e.g., patient and/or clinician or rep) to answer questions as part of a data collection process. The external system <NUM> may include a wearables such as a watch, sensors or therapy-applying devices. The watch may include sensor(s), such as sensor(s) for detecting activity, motion and/or posture. Other wearable sensor(s) may be configured for use to detect activity, motion and/or posture of the patient. The external system <NUM> may include, but is not limited to, a phone and/or a tablet.

<FIG> illustrates, by way of example and not limitation, a neuromodulation system <NUM> having a neuromodulation device <NUM> programmed with a set of more than one program <NUM> and a processing system <NUM> configured for performing a process <NUM> used to switch programs based on activity, motion and/or posture. Each program may define a set of programming parameter values to control the delivery of the neuromodulation energy. Electrical modulation energy is provided to the electrodes in accordance with values for a set of modulation parameters programmed into the waveform generator, and a microcontroller may be used to execute the program to direct and control the neuromodulation performed by the waveform generator. By way of example but not limitation, the electrical modulation energy may be in the form of a pulsed electrical waveform. The pulses may be a regular pulse pattern with consistent pulse widths, amplitudes, and pulse-to-pulse durations. The pulse pattern may include regular bursts of pulses with regular burst-to-burst intervals. The pulse pattern may include irregular patterns of pulses, with variations in the amplitude of pulses, pulses widths, pulse-to-pulse durations, etc. Such variations may be determined according to a function, or may be random or pseudo random. The electrical modulation energy may be delivered using shapes other than pulse shapes defined by a pulse width and pulse amplitude. Modulation parameters may comprise electrode combinations, which define the electrodes that are activated as anodes (positive), cathodes (negative), and turned off (zero), percentage of modulation energy assigned to each electrode (fractionalized electrode configurations), and electrical pulse parameters, which define the pulse amplitude (measured in milliamps or volts depending on whether the pulse generator supplies constant current or constant voltage to the electrode array), pulse width (measured in microseconds), pulse rate (measured in pulses per second), and burst rate (measured as the modulation on duration X and modulation off duration Y). Electrodes that are selected to transmit or receive electrical energy are referred to herein as "activated," while electrodes that are not selected to transmit or receive electrical energy are referred to herein as "non-activated. " Electrical modulation occurs between or among a plurality of activated electrodes, one of which may be the case of the waveform generator. The system may be capable of transmitting modulation energy to the tissue in a monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion. Monopolar modulation occurs when a selected one of the lead electrodes is activated along with the case of the waveform generator, so that modulation energy is transmitted between the selected electrode and case. Any of the electrodes one lead(s) and the case electrode(s) may be assigned to up to k possible groups or timing "channels. " In one embodiment, k may equal four. The timing channel identifies which electrodes are selected to synchronously source or sink current to create an electric field in the tissue to be stimulated. Amplitudes and polarities of electrodes on a channel may vary. In particular, the electrodes can be selected to be positive (anode, sourcing current), negative (cathode, sinking current), or off (no current) polarity in any of the k timing channels. The waveform generator may be operated in a mode to deliver electrical modulation energy that is therapeutically effective and causes the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain with perceived paresthesia), and may be operated in a sub-perception mode to deliver electrical modulation energy that is therapeutically effective and does not cause the patient to perceive delivery of the energy (e.g. therapeutically effective to relieve pain without perceived paresthesia). The waveform generator may be configured to individually control the magnitude of electrical current flowing through each of the electrodes. For example, a current generator may be configured to selectively generate individual current-regulated amplitudes from independent current sources for each electrode. In some embodiments, the pulse generator may have voltage regulated outputs. While individually programmable electrode amplitudes are desirable to achieve fine control, a single output source switched across electrodes may also be used, although with less fine control in programming. Neuromodulators may be designed with mixed current and voltage regulated devices. Calibration techniques are used to determine the proper current fractionalization. With the current fractionalized to a plurality of electrodes on the electrical modulation lead, the resulting field can be calculated by superimposing the fields generated by the current delivered to each electrode. The process performed the processing system to switch programs may, based on activity, motion and/or posture, automatically switch programs from the set of more than one program <NUM> or may suggest to switch programs from the set of more than one program <NUM>. The activity, motion and/or posture may be determined using sensed data indicative of activity, motion and/or posture <NUM>, which may be detected using internal and/or external sensor(s).

<FIG> illustrates, by way of example and not limitation, a neuromodulation system that determines and analyzes physiological parameters, such as activity, motion and/or posture, for use to switch between or among neuromodulation programs. The system may monitor the patient <NUM> using tracking devices <NUM> to determine, as generally illustrated at <NUM>, activity, motion and/or posture or other physiological parameters or states such as sleep. Examples of tracking devices may include a watch with sensor(s), fitness trackers, internal sensors, external sensors, or location sensor(s) such as GPS or transponder(s). A transponder signal may be indicative of a patient location, such as a particular room, a bed, a chair, a sofa, a room or a car. As generally illustrated at <NUM>, at least some of these parameter(s) may be used to provide alerts or reminders to the patient, and at least some of these parameter(s) may be used to direct control of the IPG or the therapy provided by the IPG. At least some of the tracked information <NUM> from the tracking device, such as activity, motion and/or posture, may be locally analyzed by at least one local device <NUM> such as a phone, tablet, laptop, or remote control. The analysis may be performed by one local device or distributed among at least two devices. For example, the system may analyze sleep, impedance, acceleration, bending, device usage (e.g., usage of local device or wearable/watch) and pain. The system may analyze gait, ECAPs and the like. The local analytics performed by local device(s) may be used to provide, as generally illustrated at <NUM>, therapy advice (e.g., suggestions for therapy adjustments) or may be used to provide automated therapy adjustment. At least one local device <NUM> may be used to change manual settings in the neuromodulation device, to provide therapy feedback, and/or answer questionnaires, as generally illustrated at <NUM>.

Some embodiments may execute a perception threshold mapping process for the patient for a variety of postures. For example, a wearable or a remote-control app may be used to execute a perception (pth) or neural (ECAP) threshold (nth) mapping for the patient for a variety of postures and/or activities (sitting, standing, running, working) to get a listing of posture and activities over time and map them to pth and/or nth and coverage. The process may include triggering an assessment based on external or internal signals or based on times. Examples of signals may be from one or more sensors such as an impedance sensor or an accelerometer. The assessment may be triggered by pain. Optionally, a user may be presented with a questionnaire concerning the specific activity, duration and level of pain when the assessment was triggered. The process may further include increasing amplitude until a paresthesia threshold is reached, which may be determined by the user pressing a command button or by detecting an electrophysiological signal such as ECAPs, EMG signals, or a changing galvanic response. The patient, or other user such as a manufacturer rep for the neuromodulator, may provide information about the degree and location of coverage, pain relief and may also provide other information. A set of programs created to deliver neuromodulation near the neuromodulation delivered a base program can also be tested. For example, a patient or other user may be requested to create a new pain drawing to update the coverage information. The correlation between activity and the case-specific calibration provides for an adaptive SCS systems that automatically adjusts therapy based on the patient's needs. Thus, by way of example and not limitation, a base program may be delivered when the patient is at a normal level of activity that corresponds to a first paresthesia threshold, an active program may be delivered when the patient is at a higher level of activity that corresponds to a second paresthesia threshold, and a rest program may be delivered when the patient is sleeping or otherwise resting in bed. Internal and external devices may direct close loop control in a manner that predicts how to adjust therapy according to activity and predicted pain. Various embodiments may detect when a patient is sleeping and provide additional input to optimize therapy during sleep (e.g., activating sleeping programs). Various embodiments may use transponder(s) or GPS systems to alert the SCS system of patient location such as a bed, a sofa or other room. The GPS system may be a GPS system incorporated into a smart phone, for example. Some embodiments integrate location data derived from both the GPS system and the transponder(s) to enable location-specific programs and/or behaviors. Various embodiments may include other physiological sensors such as heart rate, heart rate variability, respiration, respiration rate, respiration rate variability and oxygen levels. Respiration may be monitored using various methods, such as but not limited to transthoracic impedance, which may be used to derive tidal volume and minute ventilation data. Sound may also be used to detect heart rate and respiration data.

<FIG> illustrates, by way of example and not limitation, the creation of a variety of programs to provide neuromodulation fields <NUM> that vary around the neuromodulation field <NUM> provided by a base program. A scripting system may be used to create the programs from the base program, to automatically generate similar programs near neuromodulation field of the base program. These programs may be accessed by the patient at home.

<FIG> illustrates, by way of example and not limitation, a method for creating the variety of programs that vary around a base program. The method may use FAST neuromodulation. FAST neuromodulation provides fast-acting subperception therapy for a patient. FAST may include a fitting regime where a patient is tested with supra-perception stimulation (that the patient can feel; that produces paresthesia) to try and find a correct location for stimulation in their electrode array that well "covers" the patient's pain. Finding a correct location for stimulation is typically called "sweet spot searching," because the goal is to find a "sweet spot" in the array for stimulation that well recruits and treats the patient's symptoms, such as lower back pain. Once this "sweet spot" for stimulation in the electrode array is located, the amplitude of the stimulation is lowered to provide sub-perception stimulation (that the patient can't feel), as explained further below.

Both the sweet spot searching the eventually-determined subperception stimulation therapy may use a low-frequency (e.g., <NUM>) active recharge waveform. However, the frequency may be within a range between <NUM> to <NUM>, a range between <NUM> and <NUM>, a range between <NUM> and <NUM>, or a range between <NUM> and <NUM>. The <NUM> frequency is a specific example of a desirable parameter value. The pulse width may be <NUM>, or within a range between <NUM> to <NUM>. The active recharge waveform is biphasic, because it includes two opposite-polarity phases that are both actively driven with constant currents of opposite polarity. Active recharge waveforms recover charge during the second pulse phase (recharge) that was injected during the first pulse phase. Specifically, when current is actively driven during the first pulse phase, charge will be stored on capacitances in the current path. When the polarity and hence direction of the current is reversed during the second phase, such stored charge is actively recovered and pulled off those capacitances. The active recharge waveform used during FAST is symmetric as the amplitude and duration of the two actively-driven pulse phases are the same. However, FAST may be designed to be implemented using asymmetrical pulses.

It is not conventional to use an active recharge waveform at low frequencies in an IPG. Rather, a passive recharge waveform, which includes only a first actively-driven first pulse such as a monophasic, cathodic pulse, is conventionally used as low frequencies. Rather than actively driving a current, passive charge recovery may involve connecting the electrodes to a common voltage causing any stored charge in the current paths to equilibrate by exponential decay through the patient's tissue. Passive recharge is more energy efficient than active recharge since a current is only actively drive during one phase.

A benefit of the active recharge waveform for FAST neuromodulation is that it effectively provides two center points of stimulation using a bipole. A first pole of the bipole may be a cathode pole during the first phase and an anode pole during a second phase, and the second pole of the bipole may be an anode pole during the first phase and a cathode pole during the second phase. These anode and cathode poles need not correspond to the exact positions of the electrodes in the array, but can instead be formed as "virtual poles" between the electrodes.

It is hypothesized that an active recharge waveform affects stimulation at these two CPS locations, which facilitates the identification and optimization of stimulation to patient-specific sweet-spot(s) for pain relief. As a result, when the amplitude of the stimulation is later dropped at this location to sub-perception levels, the source of pain remains well recruited, and provides the patient "FAST" relief from their symptoms. While still providing fast-acting symptomatic relieve, the low-frequency waveforms used in FAST use less power than sub-perception therapy delivered at higher frequencies (e.g., <NUM>).

By way of example and not limitation, a FAST procedure may include trolling at a low intensity to cover the patient's worst painful area with paresthesia, then turn stimulation down to a percentage (e.g. <NUM>%) of the perception threshold, assess pain including pain while performing an activity (e.g., walking), and if pain reduction is not excellent and very quick (e.g., under <NUM> minutes), then find a better sweet spot by continuing to troll to cover the painful area and turn stimulation down to the percentage until the pain reduction is excellent and very quick. Once excellent and very quick pain relief is achieved, then the perception threshold may be measured. The sub-perception therapy's maximum amplitude may be set at or otherwise based on the perception threshold. The program may be set to a percentage (e.g., <NUM>%) lower than the perception threshold.

Additional information regarding FAST neuromodulation may be found in the following references: <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, and <CIT>, <CIT> and <CIT>.

FAST may be implemented at <NUM> to provide a base neuromodulation field. Once FAST is implemented the system automatically moves the field to a number of nearby locations (numbered <NUM>-n) x mm away, as illustrated at <NUM>. The distances to the nearby locations may be predefined based on field evidence or may be defined stochastically through a mathematical deterministic or random process (i.e., Gaussian or Poisson distributions, and the like). For each new field location, the perception threshold (PT) may be measured. For each field location the PT can be computed by measuring the Neural Threshold (NT, ECAP threshold) <NUM>. In some embodiments, the NT is used directly instead of PT <NUM>. Optionally, the stimulation amplitude may be determined using the NT <NUM>. The new program may be saved in the IPG <NUM>. These created nearby programs may be available for use by the patient. The patient can activate any one or more of the programs, or the IPG may implement a schedule sequentially activating all the nearby programs.

<FIG> illustrates, by way of example and not limitation, a method for delivering a bolus neurostimulation. Various embodiments may provide a "bolus" mode for delivering a bolus of neuromodulation therapy based on activity, motion and/or posture. The bolus mode may be turned on or off by the patient or other user, or by the system. In addition to continuous and cycling modes, patients may benefit from a FAST mode of neuromodulation being delivered "as and when needed" at relatively higher intensity for a shorter amount of time. By way of example, the bolus mode may be particularly beneficial during and right after physical activity, may be particularly beneficial for patients with non-constant pain to use only when needed, and may be particularly beneficial for patients who have previously been running FAST for an extended period of time (e.g., months), and then reporting a reduced need for stimulation.

In an embodiment, an ECAP map may be created at an initial programming visit for the intended FAST program. Just before delivering a bolus mode, a quick lead location check <NUM> may be performed by measuring the ECAP map. If the two ECAP maps differ by more than a threshold (e.g., differ more than <NUM>%) <NUM>, then the stimulation location may be automatically adjusted and the user may be prompted to recalibrate <NUM>. Otherwise, if the ECAP maps do not differ by the threshold at <NUM>, then the bolus stimulation maybe delivered <NUM>. During recalibration, the user with SW guidance determines the maximum pain paresthesia overlap, using the stimulation parameters previously established for FAST. For the new stimulation location, the NT and/or PT is determined automatically or semi automatically with sweep in amplitude and questions to the subject <NUM>. The bolus stimulation may then be delivered <NUM>.

<FIG> illustrates, by way of example and not limitation, a method for using variations in a measured parameter (e.g., impedance and/or ECAPs) as an indicator of body motion and physical activity. A surge in variability and noise in impedance reading may be used as an indicator of body motion and physical activity. In the illustrated method, impedance and/or ECAPs may be measured at <NUM>. If the impedance and/or ECAP changes exceed a variability tolerance for a time longer than a duration tolerance, as illustrated at <NUM>, then a response is triggered at <NUM>. By way of example and not limitation, the response may include at least one of changing the SCS settings, triggering a questionnaire, performing additional monitoring, or increasing a sampling rate of specific variable(s). The questionnaire may be used by a user (e.g., patient, clinician, rep) to adjust therapy or may be used by an intelligent system (e.g., a system with machine learning) to suggest or adjust the settings. The signal processing may be performed on the implantable neurostimulator, or may be performed on a remote control or an app on a mobile device. The signal processing may be correlated with wearable sensors and data provided by locally administered or cloud questionnaires. The variability may be correlated with other signals, which may be used to change the therapy altogether or just change amplitude. Some embodiments may combine with additional inputs to determine posture and physical activity such as physiological sensed signals (ECAPs, LPFs), accelerometer. <FIG> illustrates, by way of example and not limitation, impedance variability induced by body motion. An activity, such as running, may be inferred or otherwise determined if the impedance variability exceeds a threshold (ΔZ > ΔZTH) for longer than threshold amount of time (ΔT > ΔTTH). As illustrated in the figure, the value of the impedance Z varies over a threshold range <NUM> during a period of time <NUM>.

<FIG> illustrates, by way of example and not limitation, impedance variability induced by various activities over the course of a day. The day is illustrated by a timeline <NUM> with labels for Morning, Afternoon, Evening and Night. Above the timeline is an indicator of the variability of impedance (Z) <NUM>. Specific variability (e.g., a specific range of values over a specific time period) may correspond to various activity, such as waking up and breakfast, walking or exercise, other movements, lunch, walking, dinner, going to sleep, getting up for toilet during the night, and changing sleeping positions during the night. A bolus of therapy may be delivered during the walking / exercise period detected in the morning. Various events may trigger therapy changes. For example, the walking period detected in late afternoon may trigger a therapy change for mild exercise, and going to sleep may trigger another therapy change for patient rest night. The therapy may change again for the day when the patient wakes up again.

<FIG> illustrates, by way of example and not limitation, a miniaturized accelerometer or gyroscope <NUM> fitted inside a tip or a body of a lead <NUM> for use to sense movement. The lead may include electrodes, wiring electrically connecting the electrodes to a port on a proximal end of the lead, and wiring extending from the accelerometer or gyroscope to the port on the proximal end of the lead. The miniaturized accelerometer or gyroscope fitted inside a tip or a body of a lead may be implemented in an SCS system that is configured to switch programs based on activity, motion or posture. However, the miniaturized accelerometer or gyroscope fitted inside a tip or a body of a lead may be implemented in other SCS systems and in other neuromodulation systems. Furthermore, the miniaturized accelerometer or gyroscope fitted inside a tip or a body of a lead may be implemented in other implantable medical devices such as but not limited to cardiac rhythm management devices (e.g., pacemakers, cardioverters, or defibrillators).

A benefit of the integrated sensor fitted inside a tip or a body of a lead is that it provides information about movement the lead itself rather than movement of the IPG if the sensor in or on the case of the IPG. The movement and/or acceleration of at least one lead may be used to infer activity and/or posture. The illustrated accelerometer or gyroscope may be use alone or in conjunction with other sensos, such as but not limited to impedance sensing, to determine activity, motion and/or posture for the patient, and enabling a system to determine optimal therapy settings. Assessing or predicting patient activity and/or pain may be useful to timely dose a neuromodulation therapy such as a bolus of FAST as well as predict changes in paresthesia.

<FIG> illustrates, by way of example and not limitation, a strain or flex sensor for use to determine lead curvature indicative of movement or posture. The strain or flex sensor may be integrated into a lead to provide information about the lead curvature. The lead with an integrated strain or flex sensor may be implemented in an SCS system that is configured to switch programs based on activity, motion or posture, or may be implemented in other SCS systems and in other neuromodulation systems. Furthermore, lead with an integrated strain or flex sensor may be implemented in other implantable medical devices such as but not limited to cardiac rhythm management devices (e.g., pacemakers, cardioverters, or defibrillators). The sensor may be integrated into the wall of the lead to detect various forces (e.g., tension or compression) or induced flex in the wall of the lead. In the case of an SCS system, the detected lead curvature may reflect spine curvature, which may be used to infer gait and/or postural position. Analysis of curvatures of both lead and spine may be used to infer the relative movement between the spinal cord and the leads/electrodes.

The derived information from the strain or flex sensor may be used to trigger a bolus stimulation or mark changes in paresthesia. The stimulation may be adjusted based on the detected shift between the spinal cord and the leads (or electrodes on the lead). The patient's activity or pain status may be monitored based on information about the posture and gain of the patient. Flex information from the strain or flex sensor may be combined with other sensed data, such as but not limited to impedance, field potential, ECAPs, accelerometer, and the like, to detect changes with more accuracy. This complementary sensing may be desirable as changes in a stimulation field may be related to a relative shift between the spinal cord and the lead. By way of example, a fiber optic bending sensor may be used for sensing, although other sensors may be used such as a piezo-based sensor. A bending sensor may use single piece of regular single-mode fiber or multimode fiber and detect bending by characterizing transmitted intensity as a function of the fiber bending curvature. Fiber optics with fiber Bragg gratings can provide highly sensitive detection of bending/curvature/deformation. Fiber bending sensors may use infiber interferometry.

<FIG> illustrate, by way of example and not limitation, some systems with connectivity tools for extending therapy optimization. Existing connectivity tools allow us to further extend those capabilities and use the phone / remote control app as a bridge for FAST therapy optimization. Health-related data for a specific patient may be acquired using questionnaires which may be presented on a device such as a phone, tablet, watch, remote control, or clinical programmer, and various sensors including implantable sensors and external sensors (including wearable sensors such as a watch). The patient heal-related data may also include information from the therapy-providing device (e.g., implantable neuromodulator configured to deliver SCS). The information from the therapy-providing device may include usage data, battery health/life, delivered therapy (e.g., doses of total charge over time), programmed parameters for implemented programs, and the like. Various algorithms may be implemented locally (e.g., <FIG>) to determine changes to the therapy (e.g., SCS therapy). The determined changes may be automatically implemented, or may be recommended changes for a user (e.g., clinician, rep or patient) to implement. The system may include a cloud-based system for storing data for the patient and/or for a larger patient population. Algorithms, such as machine learning algorithms, may operate on the collected data to determine changes to the therapy (included automatic changes or suggested changes). The data may be analyzed and presented to clinicians through a portal to allow the clinicians to assess patient outcomes, to gain insights, and track patient progress for the therapy.

<FIG> illustrates, by way of example and not limitation, a system for automatically adjusting programs for users at home using messaging and feedback from the cloud or remote human-based or fully automated programming. The system is similar to the system illustrated in <FIG>. Additionally, the local device(s) <NUM> may be configured to share data, via a cloud-based system <NUM>, with data storage and analytic system(s) <NUM>, human operator(s) <NUM>, and/or artificial intelligence system(s) <NUM>. The data storage and analytic system(s) may be configured to receive and analyze just the patient data, or may be configured to receive and analyze data from a larger patient population. The analysis may be transferred back to the patient via the local device(s) and/or may be transferred to the cloud support (human operators <NUM> and/ or AI system(s) <NUM>). The local device(s) <NUM> may receive two-way chat support with cloud support, which may include human operator(s) <NUM> and/or AI system(s) <NUM>. The cloud support may provide therapy advice and/or control back to the patient. This advice and/or control may be based on patient-specific information and/or analytics for that patient, or may be based on information and/or analytics from a larger patient population as well as the patient-specific information and/or analytics. The system may be configured to automatically adjust the programs for users using at home messaging and feedback from the cloud or remote human-based or fully-automated programming.

The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. " Such examples may include elements in addition to those shown or described. Moreover, the present inventors also contemplate examples using combinations or permutations of those elements shown or described.

Method examples described herein may be machine or computer-implemented at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. Further, in an example, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks or cassettes, removable optical disks (e.g., compact disks and digital video disks), memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

Claim 1:
A system, comprising:
a neuromodulator configured to be programmed with a set of more than one program (<NUM>) to deliver neuromodulation; and
a processing system (<NUM>) configured to:
receive sensed data indicative of activity, motion and/or posture of a patient (<NUM>);
analyze the activity, motion and/or posture of the patient (<NUM>); and
perform a process (<NUM>), based on the analyzed activity, motion and/or posture, for switching from one program (<NUM>) in the set of more than one program (<NUM>) to another program from the set of more than one program (<NUM>), wherein performing the process (<NUM>) includes automatically implementing the other program from the set of more than one program (<NUM>) or suggesting to switch to the other program from the set of more than one program (<NUM>),
wherein the processing system (<NUM>) is configured to execute a threshold mapping for different patient postures and/or different patient activities, wherein the threshold mapping includes determining a perception threshold, a neural threshold or a baseline pain for the different patient postures and/or the different patient activities, and wherein the process (<NUM>) for switching to the other program includes determining a patient posture and/or a patient activity and selecting the other program based on the threshold mapping,
wherein the set of more than one program (<NUM>) includes a base program, and wherein the processing system (<NUM>) is configured to automatically generate a plurality of programs (<NUM>) around the base program, wherein the plurality of programs (<NUM>) are configured to provide modulation field loci at determined distances from a modulation field locus of the base program, wherein the determined distances are determined using field evidence or determined stochastically through a mathematical deterministic or random process (<NUM>), wherein the threshold mapping executed by the processing system (<NUM>) includes executing the threshold mapping for each of the plurality of programs (<NUM>) that was automatically generated.