Systems for programming a neuromodulation system

Abstract

Systems and methods for programming a neuromodulation system are provided. One or more electrodes may be determined to enable at least one of a target stimulation therapy or a target alternative stimulation therapy. The device may be programmed with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy. A signal corresponding to the stimulation when a user performs an aggressor movement may be received and one or more parameters may be adjusted when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an electrically evoked compound action potential (ECAP). Alternatively or additionally, one or more thresholds may be set when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP.

Description

SYSTEMS FOR PROGRAMMING A NEUROMODULATION SYSTEMCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 632,414, filed April 10, 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The present disclosure is generally directed to neuromodulation therapy systems, and relates more particularly to programming neuromodulation therapy systems.

[0003] Neuromodulation therapy may be carried out by sending an electric signal generated by a pulse generator to a stimulation target (e.g., nerves, non- neuronal cells, etc.), which may provide a stimulating or blocking therapy to the stimulation target. Overstimulation or under stimulation of the stimulation target may occur, which could lead to patient dissatisfaction.BRIEF SUMMARY

[0004] Example aspects of the present disclosure include:

[0005] A neuromodulation system according to at least one embodiment of the present disclosure comprises: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region via one or more electrodes; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: determine whether the one or more electrodes enable at least one of a target stimulation therapy or a target alternative stimulation therapy; program the device with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an electrically evoked compound action potential (ECAP) or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0006] Any of the aspects herein, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0007] Any of the aspects herein, wherein the aggressor movement comprises a movement that results in reducing a distance between the lead and the user’s spine.

[0008] Any of the aspects herein, wherein the aggressor movement comprises at least one of the user coughing, the user moving a supine position, or the user arching the user’s back.

[0009] Any of the aspects herein, wherein the target stimulation therapy comprises a closed loop differential target multiplexed (DTM) therapy.

[0010] Any of the aspects herein, wherein the one or more parameters are programmed to keep a prime signal of the signal within a threshold window.

[0011] Any of the aspects herein, wherein the one or more electrodes are positioned at at least one thoracic vertebrae..

[0012] Any of the aspects herein, wherein the target stimulation therapy comprises sub-perception closed loop therapy.

[0013] Any of the aspects herein, wherein the one or more electrodes are positioned at at least one of thoracic vertebrae T9 or thoracic vertebrae T10.

[0014] Any of the aspects herein, wherein the data further causes the processor to: program the device without closed-loop stimulation when the one or more electrodes do not enable the target stimulation therapy and the target alternative stimulation therapy.

[0015] Any of the aspects herein, wherein the alternative stimulation therapy comprises at least one of an alternative closed loop DTM therapy or an alternative sub-perception closed loop therapy.

[0016] Any of the aspects herein, wherein the postures state comprises a supine position.

[0017] A neuromodulation system according to at least one embodiment of the present disclosure comprises: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region via one or more electrodes; a processor; and memory capable of storing data thereon that, when processed by the processor, cause the processor to: receive target stimulation therapy data for a time period from the device, the device programmed with one or more parameters; determine whether the target stimulation therapy data satisfies one or more predetermined thresholds; adjust the one or more parameters for a first quadrant when the target stimulation therapy data does not satisfy at least one predetermined threshold of the one or more predetermined thresholds; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters in a second quadrant when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an ECAP or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP.

[0018] Any of the aspects herein, wherein the data further causes the processor to: receive input regarding one or more troubleshooting steps when the one or more thresholds do not provide adequate closed loop stimulation control.

[0019] Any of the aspects herein, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0020] Any of the aspects herein, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0021] Any of the aspects herein, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0022] A method for programming a neuromodulation system, the method according to at least one embodiment of the present disclosure comprises: determining whether one or more electrodes of a lead enable at least one of a target stimulation therapy or a target alternative stimulation therapy, the lead configured to delivery stimulation from a device to a target anatomical element; programming the device with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy; receiving a signal corresponding to the stimulation when a user performs an aggressor movement; and adjusting the one or more parameters when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an ECAP or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0023] Any of the aspects herein, wherein the aggressor movement comprises a movement that results in reducing a distance between the lead and the user’s spine.

[0024] Any of the aspects herein, wherein the one or more parameters are adjusted when the patient is in a supine position and performs the aggressor movement.

[0025] Any aspect in combination with any one or more other aspects.

[0026] Any one or more of the features disclosed herein.

[0027] Any one or more of the features as substantially disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0029] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .

[0030] Use of any one or more of the aspects or features as disclosed herein.

[0031] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0032] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0033] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0034] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0035] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0036] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0037] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0038] Fig. 1 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0039] Fig. 2 is a schematic diagram of a pair of leads according to at least one embodiment of the present disclosure;

[0040] Fig. 3 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0041] Fig. 4 is a flowchart according to at least one embodiment of the present disclosure; and

[0042] Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0043] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device such as a device for a neuromodulation therapy system.

[0044] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, orcombinations thereof (alone or in combination with instructions). Computer- readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0045] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or Al 3 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0046] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0047] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0048] Activation of neuromodulation systems after implantation varies based on different protocols and workflows. In some instances, evoked compound action potential (ECAP) signals may be low or non-existent after implantation of the neuromodulation system. In such instances, during follow-up examinations with the patient after implantation, the EECAP signals may have improved.

[0049] Thus, embodiments of the present disclosure are directed to a workflow for instances where the neuromodulation system are activated and ECAP signal quality is weak or nonexistent and reprogramming the device if needed some time after implantation when the ECAP signal has improved. Generally, the workflow prioritizes programming settings that are ideal for a working closed-loop control, then tests the programming settings to check if ECAPs are present and whether the closed-loop control is working. If ECAPs are not present and / or the closed-loop control does not work, then the device is programmed for patient comfort and is programmed with closed-loop control even though it is likely that the closed-loop control will not engage often. When the device is programmed for patient comfort, the patient may be instructed to move into a supine position and perform an aggressor movement (e.g., cough, arch their back, etc.) during such programming.

[0050] During a follow-up with the patient some time after implantation (e.g., a week or more) the device may be checked to see how often the closed-loop control is engaging and decreasing an amplitude of the stimulation. The patient is also assessed for pain relief, whether overstimulation is occurring, and patient / physician preference with respect to the stimulation therapy. The device may be reprogrammed following a similar workflow as when the device is initially programmed or the device settings may remain unchanged if the settings are satisfactory.

[0051] The workflows as described herein may beneficially reduce field time and effort when the ECAP signals are weak or nonexistent as the device can be quickly set to prioritize settings that are ideal for closed-loop control, then reprogrammed if needed once the ECAP signals are present or of better quality.

[0052] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) providing a streamlined workflow for activating and programming a neuromodulation system shortly after implantation, (2) reducing time spent programming the neuromodulation system shortly after implantation and after a time period (e.g., a week or longer) after the implantation, and (3) prioritizing patient comfort when programming the neuromodulation system.

[0053] Turning to Figs. 1-2, diagrams of aspects of a system 100 according to at least one embodiment of the present disclosure are shown. The system 100 may also be referred to as a neuromodulation therapy system or a neuromodulation system. The system 100 may be used toprovide electric signals to a patient and / or carry out one or more other aspects of one or more of the methods disclosed herein. Neurostimulation techniques (e.g., technologies that act directly upon nerves of a patient, such as the alteration, or “modulation,” of nerve activity by delivering electrical impulses directly to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments (e.g., chronic pain) of a patient. As discussed herein, neuromodulation techniques may be used to relieve chronic pain. Additionally or alternatively, neuromodulation techniques may be used to stimulate or prevent other neurological signals from traveling to or from the patient’s brain for the purposes of assisting with patient treatment. In some embodiments, the device 102 may provide electrical stimulation of the spinal cord 108 of the patient (or one or more nerves therein) to relieve chronic pain.

[0054] The system 100 may include at least a device 102 (which may be a device for, for example, a close-loop spinal cord stimulation, spinal cord stimulation, or any other type of stimulation) that is capable of providing a stimulation to, for example, the spinal cord 108 of the patient and / or to one or more nerve endings for a patient. In other embodiments, the device 102 may be used for providing stimulation to any target anatomical element of a patient to provide, for example, deep brain stimulation, pelvic health stimulation, etc. In some examples, the device 102 may be referred to as a spinal cord stimulator, a pulse generator, an implantable neural stimulator, an internal neural stimulator, or the like, which may be implantable in some embodiments. More specifically, the device 102 may be configured to generate a current or electrical signal, such as a signal capable of stimulating one or more ECAPs or ECAP responses in the spinal cord 108 or from one or more nerves.

[0055] Additionally, the system 100 may include one or more leads 104 (e.g., electrical leads) that provide a connection between the device 102 and the spinal cord or target nerves of the patient for enabling, for example, stimulation. In some embodiments, the leads 104 may be implanted wholly or partially within the patient. The leads 104 may be, for example, paddle leads, cylindrical leads, cuff electrodes, and / or percutaneous leads. In some embodiments, the one or more leads 104 may include a first lead 104A disposed on or connected to a first side of the spinal cord 108 of the patient and a second lead 104B disposed on or connected to a second side of the spinal cord 108 of the patient. For example, the first lead 104A may be connected to the righthand side of the spinal cord 108, while the second lead 104B may be connected to the lefthand side of the spinal cord 108. However, the position and / or orientation of each lead relative to the spinal cord 108 may vary depending on, for example, the type of treatment, the type of lead, combinations thereof, and the like. In another example, the first lead 104A and the second lead 104B may overlap one another, and may be placedproximate one another on the dorsal side of the spinal cord 108 close to a midline of the spinal cord 108. In some examples, the first lead 104A and the second lead 104B may both be placed on the midline of the spinal cord 108, where one of the leads 104 is cranial (e.g., anterior or nearer the head of the patient) and the other of the leads 104 is caudal (e.g., posterior or nearer the tail of the patient). Additionally or alternatively, the first lead 104A and the second lead 104B may both be placed on one side of the midline of the spinal cord 108.

[0056] In some embodiments, the leads 104 may be or comprise linear spinal cord stimulation (SCS) leads capable of delivering one or more stimulation signals to the spinal cord 108, as discussed in further detail below. The leads 104 may comprise a plurality of electrodes 110A, HOB disposed along the length of the lead 104, such that the leads 104 contact the spinal cord 108 at multiple points along a length of the spinal cord 108. A first set of the electrodes on each lead may pass an electrical signal into the spinal cord 108, while a second set of the electrodes on each lead may sense one or more signals generated in response by the spinal cord 108. In one embodiment, the electrodes may be able to sense, measure, or otherwise collect data related to ECAPs (e.g., ECAP waveforms).

[0057] Fig. 2 depicts the device 102 and the leads 104A, 104B connected to the spinal cord 108 of the patient, the leads 104 including the one or more electrodes 110A, HOB that receive a current or other stimulant instructions from the device 102 (e.g., via the leads 104).

[0058] More specifically, as shown in Fig. 2, in embodiments where the lead 108 includes a pair of leads 104 A, 104B, the leads 104A, 104B may be implanted on or near a target anatomical element such as near the spinal cord 108. More specifically the leads 104A, 104B may be implanted at thoracic levels T7, T8, T9, T10, Ti l, and / or T12 of the patient. It will be appreciated that in other embodiments, the leads 104A, 104B (or a singular lead), may be implanted anywhere on the spinal cord 108 or may be implanted near any target anatomical element and / or target nerve(s). Once implanted, the leads 104A, 104B may provide an electrical signal (whether stimulating or blocking) from the device 102 to the target anatomical element (e.g., one or more nerves in the spinal cord, the brain, etc.). The device 102, in some embodiments, may be implanted in the patient, though in other embodiments - such as during testing of the leads 104 A, 104B. In some embodiments, the device 102 may be an external neurostimulator that is external to the patient’s body.

[0059] The application of current to the spinal cord 108 may stimulate an ECAP in the spinal cord or nerve of the patient, and data or information associated with the ECAP may be captured using, for example, the one or more of the electrodes 110A, HOB. For example, one or more of the electrodes 110A, HOB may generate an electric signal that stimulates the spinal cord 108. The stimulation maycause one or more ECAP responses, which may be sensed, detected, and / or measured by the electrodes 110A, HOB that were not used to stimulate the spinal cord. For example, the electrodes 110A may stimulate the spinal cord 108, while the electrodes HOB sense the ECAP response. In other embodiments, a first set of electrodes (whether electrodes 110A and / or HOB) may stimulate the spinal cord 108, while a second set of electrodes (whether electrodes 110A and / or HOB) may measure the spinal cord 108 response, including capturing ECAP waveform data.

[0060] The system 100 or similar systems may be used, for example, to carry out one or more aspects of the methods 400, 500 described herein. The system 100 or similar systems may also be used for other purposes. It will be appreciated that the human body has many nerves and the stimulation and / or measurement described herein may be applied to one or more nerves, which may reside at any location of a patient (e.g., lumbar, thoracic, etc.). Further, the use of the leads 104 to stimulate and / or measure ECAPs may occur with different portions of the nervous system. For example, the leads 104 may be connected to one or more of nerve endings in the spinal cord, the brain or portions thereof, combinations thereof, and the like.

[0061] Additionally, while not shown in Figs. 1-2, the system 100 may include one or more processors (e.g., one or more DSPs, general purpose microprocessors, graphics processing units, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry) shown and described in Fig. 3 that are programmed to carry out one or more aspects of the present disclosure. In some examples, the one or more processors may include a memory or may be otherwise configured to perform the aspects of the present disclosure. For example, the one or more processors may provide instructions to the device 102 or other components of the system 100 not explicitly shown or described with reference to Fig. 1 for generating stimulation of one or more nerves, and / or measuring ECAPs, or a combination thereof, as described herein. In some examples, the one or more processors may be part of the device 102 or part of a control unit for the system 100 (e.g., where the control unit is in communication with the device 102 and / or other components of the system 100).

[0062] Turning to Fig. 3, a block diagram of a system 300 according to at least one embodiment of the present disclosure is shown. The system 300 may be used with the system 100 or components thereof, and / or may carry out one or more other aspects of one or more of the methods disclosed herein. The system 300 comprises the device 102, a computing device 302, a database 330, and / or a cloud or other cloud network 334. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 300. For example, the system 300 may not include one or more components of the computing device 302, the database 330, and / or the cloud network 334. While the computing device 302 of the system 300 is illustrated as being incommunication with the device 102, it is to be understood that the computing device 302 may be disposed as a sub-component within the device 102, or may alternatively be an external device that communicates with the device 102 using, for example, a communication interface 308, or through the cloud 334 or other network. In some embodiments, the device 102 may include any one or more components of the system 300 including, but not limited to, the computing device 302, the processor 304, the memory 306, the communication interface 308, the database 330, a data model 332, combinations thereof, and the like.

[0063] The device 102 may comprise the leads 104 and the electrodes 110A, HOB. As previously described, the leads 104 and the electrodes 110A, HOB may be configured to apply the current to an anatomical element (e.g., the spinal cord, one or more nerves, etc.). The device 102 may communicate with the computing device 302 to receive instructions such as instructions for applying a current to the anatomical element. The device 102 may also provide data (such as data received from or measured by the electrodes 110A, HOB), which may be used to control the device 102.

[0064] The computing device 302 comprises a processor 304, a memory 306, a communication interface 308, and a user interface 310. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 302.

[0065] The processor 304 of the computing device 302 may be any processor described herein or any similar processor. The processor 304 may be configured to execute instructions stored in the memory 306, which instructions may cause the processor 304 to carry out one or more computing steps utilizing or based on data received from the device 102, the database 330, and / or the cloud network 334.

[0066] The memory 306 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and / or instructions. The memory 306 may store information or data useful for completing, for example, one or more steps of the methods 400 and / or 500 described herein, or of any other methods. The memory 306 may store, for example, instructions and / or machine learning models (e.g., neural networks) that support one or more functions of the device 102. For instance, the memory 306 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 304, enable parameter adjustments 324.

[0067] The memory 306 may also store data for executing the parameter adjustments 324. Data for parameter adjustments 324 may correspond to a routine executed by the processor 304 to adjust one or more parameters of the electrical signal used in an electrical stimulation. Adjustments may be achieved by adjusting signal current, adjusting signal amplitude, adjusting signal frequency,adjusting signal type (e.g., square wave, sinusoidal wave, triangle wave, etc.), adjusting duty cycle, adjusting treatment duration, electrode combination (e.g., which electrodes are stimulating), signal polarity (positive or negative), and / or the like.

[0068] The memory 306 may also store one or more workflow(s) 322 and / or information about one or more workflows 322. The one or more workflows 322 may provide guidance for initially programming the device 102 immediately after implantation of the device 102 and the lead(s) 104 into a patient. The one or more workflows 322 may also provide guidance for updating the programming of the device 102 after a time period after the implantation of the device 102. The time period may be, for example, one or more hours, one or more days, one or more weeks, one or more months, or one or more years. The one or more workflows 322 may include, for example, steps for programming the device 102. The one or more workflows 322 may be executed by, for example, a user such as a clinician, a medial provider, a patient, or the like, may be automatically executed by, for example, a processor such as the processor 204, and / or may be executed partially by the user and partially by the processor. In embodiments where one or more steps are executed by the user, the one or more steps may be communicated to the user by, for example, the user interface 310.

[0069] Content stored in the memory 306, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 306 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 304 to carry out the various method and features described herein. For example, the memory 306 may store one or more parameters of the device 102 and / or one or more predetermined thresholds which may be used to, for example, determine which sets of data to use to adjust the one or more parameters. Thus, although various contents of memory 306 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 304 to manipulate data stored in the memory 306 and / or received from or via the device 102, the database 330, and / or the cloud network 334.

[0070] The computing device 302 may also comprise a communication interface 308. The communication interface 308 may be used for receiving data (for example, data from the device 102) or other information from an external source (such as the device 102, the database 330, the cloud network 334, and / or any other system or component not part of the system 300), and / or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 302, the device 102, the database 330, the cloud network 334, and / or any othersystem or component not part of the system 300). The communication interface 308 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive information via one or more wireless communication protocols such as 602.1 la / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 308 may be useful for enabling the computing device 302 to communicate with one or more other processors 304 or computing devices 302, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0071] The computing device 302 may also comprise one or more user interfaces 310. The user interface 310 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 310 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 300 (e.g., by the processor 304 or another component of the system 300) or received by the system 300 from a source external to the system 300. In some embodiments, the user interface 310 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 304 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 310 or corresponding thereto.

[0072] Although the user interface 310 is shown as part of the computing device 302, in some embodiments, the computing device 302 may utilize a user interface 310 that is housed separately from one or more remaining components of the computing device 302. In some embodiments, the user interface 310 may be located proximate one or more other components of the computing device 302, while in other embodiments, the user interface 310 may be located remotely from one or more other components of the computing device 302.

[0073] The database 330 may store information such as patient data, lead parameters, ECAP waveform data or similar data, electrode parameters, threshold values, distance values, etc. The database 330 may be configured to provide any such information to the computing device 302, the device 102 of the system 100, or to any other device of the systems 100, 300 or external to the system 300, whether directly or via the cloud network 334. In some embodiments, the database 330 may be or comprise part of a hospital image storage system, such as a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records.

[0074] The cloud network 334 may be or represent the Internet or any other wide area network. The computing device 302 may be connected to the cloud network 334 via the communication interface 308, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 302 may communicate with the database 330 and / or an external device (e.g., a computing device) via the cloud network 334.

[0075] The system 300 or similar systems may be used, for example, to carry out one or more aspects of the methods 400 and / or 500 described herein. The system 300 or similar systems may also be used for other purposes.

[0076] Fig. 4 depicts a method 400 that may be used, for example, for programming a neuromodulation system such as the neuromodulation system 100 after implantation of the neuromodulation system 100. More specifically, the method 400 may be used to program the neuromodulation system 100 for closed loop differential target multiplexed (DTM) stimulation therapy or sub-perception closed loop stimulation therapy. It will be appreciated that in other embodiments the method 400 may be used to program the neuromodulation system 100 for any stimulation therapy. In some embodiments, the neuromodulation system 100 may be programmed within one day of implantation. In other embodiments, the neuromodulation system 100 may be programmed more than a day after implantation.

[0077] The method 400 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 304 of the computing device 302 described above. The at least one processor may be part of the neuromodulation system 100. A processor other than any processor described herein may also be used to execute the method 400. The at least one processor may perform the method 400 by executing elements stored in a memory such as the memory 306. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 400. One or more portions of a method 400 may be performed by the processor executing any of the contents of memory, such as a stimulation optimization 324.

[0078] The method 400 comprises determining if one or more electrodes can be programmed to a desired stimulation therapy (step 404). The one or more electrodes may be the same as or similar to the one or more electrodes 110A, 110B of a lead such as the lead 104. As previously described, the lead may be configured to deliver stimulation from a device such as the device 102 to a target anatomical element or region via the one or more electrodes. The lead may include a pair of leads positioned in a spinal region of a patient. More specifically, the pair of leads (and correspondingelectrodes) may be implanted at any thoracic level of the patient. It will be appreciated that in other embodiments, the leads (or a singular lead), may be implanted anywhere on the spinal cord or may be implanted near any target anatomical element and / or target nerve(s). The target or desired stimulation therapy may be, for example, a closed loop DTM stimulation therapy or a sub-perception closed loop stimulation therapy. It will be appreciated that the target or desired stimulation therapy may be any stimulation therapy.

[0079] The step 404 may more specifically determine if target electrodes can be programmed for the target or desired stimulation therapy such as, for example, the closed loop DTM stimulation therapy or the sub-perception closed loop stimulation therapy. If the target electrodes can be programmed for the target or desired stimulation therapy, then the method 400 may move to the step 416 (in which the steps 408 and / or 412 may not occur). If the target electrodes cannot be programmed for the target or desired stimulation therapy, then the method 400 may proceed to step 408, described below.

[0080] The method 400 also comprises determining if the one or more electrodes can be programmed for an alternative target stimulation therapy (step 408). Determining if the one or more electrodes can be programmed for the alternative target stimulation therapy may include, for example, modifying the electrode configuration. If the electrode configuration can be adequately modified, then the method 400 may move to the step 416. If the electrode configuration cannot be adequately modified, then the method 400 may move to the step 412, described below.

[0081] It will be appreciated that in some embodiments the method 400 may not include the step 408. For example, the step 408 may not occur for non-DTM therapies.

[0082] Generally, the steps 404 and 408 may comprise determining if the one or more electrodes enable the target stimulation therapy or the adjusted target stimulation therapy. If the one or more electrodes can enable the target stimulation therapy or the adjusted target stimulation therapy, then the method 400 may proceed to the step 416. If the one or more electrodes cannot be programmed to enable the target stimulation therapy or the adjusted target stimulation therapy, then the method 400 may proceed to the step 412.

[0083] The method 400 also comprises programming the device to an alternative closed-loop therapy or without closed-loop stimulation therapy (step 412). In embodiments where the one or more electrodes cannot be programmed with the target stimulation therapy (e.g., the closed loop DTM stimulation therapy or the sub-perception closed loop stimulation therapy) or the alternative target stimulation therapy, then the device can be programmed with a different therapy such as, forexample, DTM without closed loop stimulation with adaptive stimulation, closed loop stimulation with high dose settings, closed loop stimulation with low dose settings, etc.

[0084] The method 400 also comprises programming the device with one or more parameters and capturing a signal from the device (step 416). The device may be programmed with the one or more parameters when it is determined that the one or more electrodes enable the target stimulation therapy or the alternative target stimulation therapy. The one or more parameters may include, for example, selection of stimulation electrodes, selection of quadrants for stimulation, setting a threshold for a first program (Pl) and a second program (P2) (which may include, for example, frequency, amplitude, and duration), and / or stimulation therapy type.

[0085] In embodiments where the target stimulation therapy is closed loop DTM stimulation therapy, the stimulating electrodes may be selected based on vertebral body targets determined from imaging of the patient (e.g., X-rays, fluoroscopic imaging, ultrasound imaging, etc.) and programmed closest to the closed loop DTM stimulation therapy. Further, Pl may be set to a perception threshold and P2 may be set to a percentage of the perception threshold. In such embodiments, the device may be programmed to prioritize keeping Pl within the threshold. In some embodiments, the P2 may be set to 65% of the perception threshold. In other embodiments, P2 may be set to a percentage of the perception threshold greater than or less than 65%. If the Pl or P2 results in nerve root stimulation, then the stimulating electrodes may be changed to alternative stimulating electrodes.

[0086] In embodiments where the target stimulation therapy is closed loop sub-perception stimulation therapy, the stimulating electrodes may be selected at a disc space between target thoracic vertebrae. The electrodes may also be set based on the imaging of the patient’s spine anatomy. Further, Pl may be set to a perception threshold and P2 may be set to a percentage of the perception threshold just under the perception threshold. For example, the P2 may be set to 90% of the perception threshold. It will be appreciated that P2 can be set to any percentage of the perception threshold. For example, Pl may be set to 50 Hz and 200pS and P2 may be set to 1000Hz, 200pS.

[0087] The one or more parameters may be programmed automatically by, for example, a processor such as the processor 304 or any other processor. The one or more parameters may also be programmed by a user such as a surgeon or other medical provider via, for example, a user interface such as the user interface 310. In still other instances, the one or more parameters may be programmed automatically and approved by the user.

[0088] In any embodiment, after the device is programmed with the one or more parameters, the device is operated with the one or more parameters and a signal is captured as a result of thestimulation generated by the device and delivered by the lead and the one or more electrodes. The signal may be recorded by, for example, one or more electrodes configured to record the signal. For example, in some embodiments at least one first electrode of the one or more electrodes may be configured to deliver the stimulation and at least one second electrode of the one or more electrodes may be configured to record the signal. In other words, in instances where a signal is recorded, the one or more electrodes include at least two electrodes - at least one electrode to deliver the stimulation and at least one electrode to record the signal

[0089] The step 416 may alternatively or additionally include programming the one or more parameters and one or more electrodes providing stimulation in a quadrant to provide a pain coverage that relieves as much as possible or all of a patient’s pain. If the programmed device relieves pain at Pl, then the method 400 can proceed to the step 420. Whether the device relieves the patient’s pain at Pl can be determined based on, for example, feedback received from the patient on whether the patient feels pain. The patient feedback may be communicated via a user interface such as the user interface 310 and / or to a user such as a clinician or other medical provider. If the device does not relieve enough of or all of the patient’s pain at Pl, the one or more parameters may be adjusted to set P2 to cover the remaining portion of the pain that is not covered by Pl .

[0090] The method 400 also comprises determining if ECAPs are present in the signal when a user performs an aggressor movement (step 420). Stated differently, the step 420 may comprise receiving a signal as a result of the stimulation when the user performs the aggressor movement and determining if ECAPs are present in such signals. The aggressor movement may be a movement that results in reducing a distance between the lead and the user’s spine. For example, the aggressor movement may be the user coughing, the user moving a supine position, the user arching the user’s back, etc. If the signal includes the ECAP, then the method 400 may proceed to step 428. If the signal does not include the ECAP, then the method 400 may proceed to step 424, described below.

[0091] The method 400 also comprises adjusting the one or more parameters, activating closed- loop therapy, and setting reaction and recovery thresholds (step 424). The one or more parameters of the device may be adjusted when it is determined that ECAPs are not present in the signal in the step 420. The one or more parameters may be adjusted automatically by, for example, a processor such as the processor 304 or any other processor (which may use, for example, a parameter adjustment such as the parameter adjustment 324). The one or more parameters may also be adjusted by a user such as a surgeon or other medical provider via, for example, a user interface such as the user interface 310. In still other instances, the one or more parameters may be adjusted automatically and approved by the user.

[0092] Adjusting the one or more parameters may include turning off the closed loop aspect while leaving the stimulation on (whether DTM or sub-perception stimulation) and setting an amplitude of Pl to zero. The patient is then instructed to move to a posture state such as a supine position. It will be appreciated that the posture state may include any posture or position such as, for example, standing, sitting, supine or any activity state such as, for example, walking, back arching, running, jumping, etc. In embodiments where the patient is in the supine position and paresthesia is present, P2 can be lowered until sub-perception of the paresthesia and the patient is comfortable with an aggressor movement such as, for example, a cough. In the same embodiments, Pl may be set to a level where the patient is comfortable with a cough while in the supine position.

[0093] After Pl and / or P2 are set, the closed loop aspect may be turned back on. A reaction threshold of the closed-loop stimulation may be set to 7pV and a recovery threshold may be set to 4 pV (which may be out of a noise floor). In other words, the reaction threshold and the recovery threshold may be set above the noise floor. After the one or more parameters are appropriately adjusted and the closed-loop is turned on, the method 400 may proceed to step 436.

[0094] In other embodiments such as, for example, light- or sub-paresthesia threshold (subPT) therapy, desired programming may be paresthesia mapped for target anatomies. It will be appreciated that in the subPT therapy, one target of desired stimulation targets may be modified to facilitate ECAP capture, while allowing other stimulation targets to remain constant. In still other instances such as, for example, paresthesia rich or low dose (LD) therapy, desired programming may be paresthesia mapped to cover the largest possible area of pain. It will be appreciated that the LD therapy may include additional programming options to cover more area of the pain.

[0095] The method 400 also comprises setting one or more thresholds (step 428). The one or more thresholds may be set when it is determined that ECAPs are present in the signal in the step 420. The one or more thresholds may be, for example, the reaction threshold and the recovery threshold. The reaction threshold and the recovery threshold may be set based on patient feedback regarding a comfort of the patient. In some embodiments, the reaction threshold and the recovery threshold may be initially set at a predetermined value. For example, the reaction threshold may be initially set at 7 p V and the recovery threshold may be set at 4 p V. In another example, the recovery threshold may be set at 3 pV below the reaction threshold.

[0096] The step 428 may also include confirming an appropriate ECAP window for the stimulation therapy and testing if the closed loop control (whether DTM or sub-perception stimulation) provides comfortable perception or no perception when the patient performs anaggressor movement. The step 428 may also include testing the closed loop control with the patient in a supine state and with the patient performing an aggressor movement.

[0097] Additionally or alternatively, the one or more thresholds may be set to provide comfortable sensation for the patient. Feedback on such settings may be provided by the patient as patient feedback.

[0098] The method 400 also comprises determining if the device as programmed provides adequate closed-loop control (step 432). Determining whether the device provides adequate closed- loop control may include receiving patient feedback on, for example, an efficacy of the stimulation, if pain is present, and / or if paresthesia is present. Alternatively or additionally, a signal level and / or stimulation amplitude of the signal while streaming the signal may be analyzed to determine if the device provides adequate closed-loop control. If the device is determined to provide adequate closed-loop control, then the method 400 may proceed to step 436. If the device is determined to not provide adequate closed-loop control, then the method 400 returns to the step 424 to adjust one or more parameters of the device.

[0099] The method 400 also comprises completing setup of the device with the stimulation therapy or the modified stimulation therapy (step 436). Completing setup of the device may include, for example, checking a recharge interval of the device (e.g., an interval at which the device is charged to keep the device active). Completing the setup of the device may also include setting a low energy group and / or cycling for the stimulation therapy (whether DTM or sub-perception stimulation).

[0100] It will be appreciated that after the method 400 is completed (whether at the step 436 or the step 412), a follow-up assessment may be performed to check and review if the neuromodulation system has started to capture ECAP signals. Such follow-up is described in the method 500 below.

[0101] The present disclosure encompasses embodiments of the method 400 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0102] Fig. 5 depicts a method 500 that may be used, for example, for programming a neuromodulation system such as the neuromodulation system 100 after a time period after implantation of the neuromodulation system 100. The time period may be, for example, one or more hours, one or more days, one or more weeks, one or more months, or one or more years. The method 500 may be used to program the neuromodulation system 100 for closed loop DTM stimulation therapy, sub-perception closed loop stimulation therapy, and / or low dose closed loop stimulation therapy. It will be appreciated that in other embodiments the method 500 may be used to program the neuromodulation system 100 for any stimulation therapy. The method 500 may be used after themethod 400 described above and after the time period. For example, the method 500 may be carried out a week after the method 400. It will be appreciated that in other embodiments, the method 500 may be carried out at any time.

[0103] The method 500 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 304 of the computing device 302 described above. The at least one processor may be part of the neuromodulation system 100. A processor other than any processor described herein may also be used to execute the method 500. The at least one processor may perform the method 500 by executing elements stored in a memory such as the memory 306. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 500. One or more portions of a method 500 may be performed by the processor executing any of the contents of memory, such as a stimulation optimization 324.

[0104] The method 500 comprises receive stimulation therapy data (step 504). The stimulation therapy data may be received from a device such as the device 102. As previously described, the device may be configured to provide stimulation. A lead such as the lead 104 may be configured to deliver the stimulation to a target anatomical element or region via one or more electrodes such as the one or more electrodes 110A, HOB. As previously described, the lead may include a pair of leads positioned in a spinal region of a patient. More specifically, the pair of leads (and corresponding electrodes) may be implanted at any thoracic levels of the patient. It will be appreciated that in other embodiments, the leads (or a singular lead), may be implanted anywhere on the spinal cord or may be implanted near any target anatomical element and / or target nerve(s).

[0105] The stimulation therapy data may include data recorded over the time period. For example, the stimulation therapy data may include data recording over a week since the device was implanted. The stimulation therapy data may include data on the efficacy of the programmed stimulation therapy (whether programmed in the method 400 or the method 500 above). For example, the stimulation therapy data may include how often an amplitude of a signal was at a target or was suppressed. In such examples, increased suppression may indicate more aggressor movements by the patient and / or improvement in the ECAP triggering closed loop algorithm. In another example, a recharge history may be received. The recharge history may indicate that the device may benefit from being programmed to a low energy option.

[0106] The method 500 also comprises determine if the target stimulation therapy data satisfies all of one or more thresholds (step 508). The one or more thresholds include, for example, whetheradequate pain relief is provided by the closed loop stimulation therapy, whether overstimulation is controlled with the closed loop stimulation therapy, and whether a representative such as, for example, a key opinion leader, approves of the settings.

[0107] Whether adequate pain relief is provided may be determined based on patient feedback. The patient feedback may be provided to, for example, a user interface such as the user interface 310. Additionally or alternatively, the patient feedback may be provided to a user such as a clinician or other medical provider. The user may also input the patient feedback to the user interface.

[0108] Whether overstimulation is controlled with the closed loop stimulation therapy may be determined based on the target stimulation therapy data. For example, the target stimulation therapy data may include recorded signal data (such as, for example, a neuromodulation sense usage chart) that can be analyzed to determine if overstimulation is controlled with the closed loop stimulation therapy.

[0109] Whether the representative approves of the settings may be determined based on the representative’s feedback. The representative may not approve of the settings for a variety of reasons. For example, the representative may have a desire to see the closed-loop algorithm engaged more, desire to see better dosing, and / or may want a patient to remotely try a backup option.

[0110] It will be appreciated that the one or more thresholds may pertain to any thresholds or modified thresholds.

[0111] A processor such as the processor 104 may receive the inputs described above and may automatically determine if the target stimulation therapy satisfies all of the one or more thresholds. In other embodiments, the user may determine if the target stimulation therapy satisfies all of the one or more thresholds. In still other embodiments, the processor may determine if the target stimulation therapy satisfies all of the one or more thresholds and may then prompt the user to approve of the determination.

[0112] If the target stimulation therapy data satisfies all of the one or more thresholds, then the method may proceed to the step 548 for completion of setup of the device. If the target stimulation therapy data does not satisfy all of the one or more thresholds, then the method may proceed to the step 512 to adjust one or more parameters of the device.

[0113] The method 500 also comprises copying existing settings (step 512). The step 612 may be the same as or similar to the step 416 of the method 400 described above with respect to capturing the signal from the device. In some embodiments, all of the existing settings may be copied for the device. In other embodiments, at least some of the existing settings are copied for the device.

[0114] The method 500 also comprises determining if ECAPs are present in the signal when a user performs an aggressor movement (step 516). Stated differently, the step 516 may comprise receiving a signal as a result of the stimulation when the user performs the aggressor movement and determining if ECAPs are present in such signals. The step 516 may be the same as or similar to the step 420 of the method 400 described above. If ECAPS are determined to be present in the signal, then the method 500 may proceed to the step 520. If ECAPs are determined not to be present in the signal, then the method 500 may proceed to the step 536. It will be appreciated that in some embodiments, if ECAPs are not present, the method 500 may move to the steps 544 or 548. For example, a user such as the representative may determine that the device programming is acceptable without ECAPs.

[0115] The method 500 also comprises setting one or more thresholds (step 520). The step 520 may be the same as or similar to the step 428 of the method 400 described above.

[0116] The method 500 also comprises determining if the device as programmed provides adequate closed-loop control (step 524). The step 534 may be the same as or similar to the step 432 of the method 400 described above. If the device is determined to provide adequate closed-loop control, then the method 500 may proceed to step 548. If the device is determined to not provide adequate closed-loop control, then the method 500 proceeds to the step 528 to attempt troubleshooting the device.

[0117] The method 500 also comprises troubleshooting the device (step 528). A user such as a clinician or other medical provider and / or the patient may perform one or more troubleshooting steps when the device as programmed is determined to not provide adequate closed-loop control.

[0118] The one or more troubleshooting steps may include, for example, distinguishing ECAPs from noise in the signal. In such examples, the ECAPS may rise out of noise with an aggressor movement and conduction velocity should create a peak and a trough in similar areas across different timepoints of the signal. Further, patient feedback can be used to distinguish the ECAPs as the ECAPS will be present with paresthesia experienced by the patient.

[0119] The one or more troubleshooting steps may also include trying different Pl quadrants and confirming that a peak window and a trough window are correct when the patient finds the paresthesia acceptable and no ECAP is present. In such embodiments, an amplitude of the stimulation may be increased based on patient feedback regarding patient comfort with respect to the increasing amplitude.

[0120] The one or more troubleshooting steps may also include trying different Pl quadrants and confirming that a peak window and a trough window are correct when the patient finds the paresthesia unacceptable and no ECAP is present.

[0121] The one or more troubleshooting steps may also include trying different Pl quadrants and trying a wide stimulation bipole or increasing a pulse width (up to, for example, 200 pS) when the patient does not experience paresthesia and no ECAP is present up to 10 mA.

[0122] The one or more troubleshooting steps may also include trying different Pl quadrants, confirming that a peak window and a trough window are correct, and / or trying a different sensing electrode configuration such as, for example, a wide sense configuration, when a weak ECAP is present in the signal.

[0123] The one or more troubleshooting steps may also include trying different Pl quadrants and confirming that a peak window and a trough window are correct when the patient finds the paresthesia unacceptable in a supine position or with aggressor movements. In such embodiment, the current one or more parameters may be copied and adjusted to create a supine group, which can be used as a primary group. Additionally or alternatively, if the noise is low noise (e.g., 1-2 pV below 7 pV of a reaction threshold minimum), the noise can be increased with wide or near Pl stim, wide sense, or decreasing noise reduction to a low setting.

[0124] The one or more troubleshooting steps may also include programming modified stimulation therapies (e.g., modified DTM) if the patient does not have satisfactory pain relief and / or experiences overstimulation. In such embodiments, the closed loop stimulation therapy may also be set such that the algorithm does not engage often.

[0125] After one or more of the troubleshooting steps are performed, the method 500 may return to the step 524. However, the method 500 may proceed to the step 532 if troubleshooting is exahausted.

[0126] The method 500 also comprises determining if the device can be programmed in an alternative quadrant (step 536). If the device cannot be programmed in an alternative quadrant, then the method 500 may proceed to the step 544. If the device can be programmed in an alternative quadrant, then the method 500 may proceed to the step 540.

[0127] The method 500 comprises attempting to program the device in a different quadrant (step 540). After the device is programmed in a different quadrant, the method 500 returns to the step 516 to determine if ECAPS are now present in the signal when the patient performs an aggressor movement. The method 500 may repeat the steps 536 and 540 if the ECAPS are not present in the signal when the patient performs an aggressor movement such that the device is reprogrammed indifferent quadrants until an ECAP is present in the signal when the patient performs an aggressor movement.

[0128] The method 500 comprises selecting a patient preferred therapy or setting up a therapy (step 544). The patient preferred therapy may be, for example, a closed loop therapy. In instances where the therapy is selected and set up for the patient, the therapy may be, for example, a nonclosed loop therapy.

[0129] The method 500 comprises completing setup of the device with the stimulation therapy (step 548). The step 548 may be the same as or similar to the step 436 of the method 400 described above.

[0130] The present disclosure encompasses embodiments of the method 500 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0131] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Figs. 4 and 5 (and the corresponding description of the methods 400 and 500), as well as methods that include additional steps beyond those identified in Figs. 4 and5(and the corresponding description of the methods 400 and 500). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

[0132] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0133] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within theskill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0134] Aspects of this disclosure may be further described by reference to the following examples:

[0135] Example 1. A neuromodulation system comprising: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region via one or more electrodes; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: determine whether the one or more electrodes enable at least one of a target stimulation therapy or a target alternative stimulation therapy; program the device with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an electrically evoked compound action potential (ECAP) or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0136] Example 2. The system of example 1, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0137] Example 3. The system of example 1, wherein the aggressor movement comprises a movement that results in reducing a distance between the lead and the user’s spine.

[0138] Example 4. The system of example 1, wherein the aggressor movement comprises at least one of the user coughing, the user moving a supine position, or the user arching the user’s back.

[0139] Example 5. The system of example 1, wherein the target stimulation therapy comprises a closed loop differential target multiplexed (DTM) therapy.

[0140] Example 6. The system of example 5, wherein the one or more parameters are programmed to keep a prime signal of the signal within a threshold window.

[0141] Example 7. The system of example 5, wherein the one or more electrodes are positioned at at least one thoracic vertebrae.

[0142] Example 8. The system of example 1, wherein the target stimulation therapy comprises sub-perception closed loop therapy.

[0143] Example 9. The system of example 8, wherein the one or more electrodes are positioned at at least one of thoracic vertebrae T9 or thoracic vertebrae T10.

[0144] Example 10. The system of example 1, wherein the data further causes the processor to: program the device without closed-loop stimulation when the one or more electrodes do not enable the target stimulation therapy and the target alternative stimulation therapy.

[0145] Example 11. The system of example 1, wherein the alternative stimulation therapy comprises at least one of an alternative closed loop DTM therapy or an alternative sub-perception closed loop therapy.

[0146] Example 12. The system of example 1, wherein the postures state comprises a supine position.

[0147] Example 13. A neuromodulation system comprising: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region via one or more electrodes; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: receive target stimulation therapy data for a time period from the device, the device programmed with one or more parameters; determine whether the target stimulation therapy data satisfies one or more predetermined thresholds; adjust the one or more parameters for a first quadrant when the target stimulation therapy data does not satisfy at least one predetermined threshold of the one or more predetermined thresholds; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters in a second quadrant when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an ECAP or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP.

[0148] Example 14. The system of example 13, wherein the data further causes the processor to: receive input regarding one or more troubleshooting steps when the one or more thresholds do not provide adequate closed loop stimulation control.

[0149] Example 15. The system of example 13, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0150] Example 16. The system of example 13, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0151] Example 17. The system of example 13, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

[0152] Example 18. A method for programming a neuromodulation system, the method comprising: determining whether one or more electrodes of a lead enable at least one of a target stimulation therapy or a target alternative stimulation therapy, the lead configured to delivery stimulation from a device to a target anatomical element; programming the device with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy; receiving a signal corresponding to the stimulation when a user performs an aggressor movement; and adjusting the one or more parameters when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an ECAP or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

[0153] Example 19. The method of example 18, wherein the aggressor movement comprises a movement that results in reducing a distance between the lead and the user’s spine.

[0154] Example 20. The method of example 18, wherein the one or more parameters are adjusted when the patient is in a supine position and performs the aggressor movement.

Claims

CLAIMSWhat is claimed is:

1. A neuromodulation system (100) comprising: a device (102) configured to generate a stimulation; a lead (104) configured to deliver the stimulation to a target anatomical region via one or more electrodes (110A, HOB); a processor (304); and a memory (306) capable of storing data thereon that, when processed by the processor, cause the processor to: determine whether the one or more electrodes enable at least one of a target stimulation therapy or a target alternative stimulation therapy; program the device with one or more parameters based on the target stimulation therapy or the target alternative stimulation therapy; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an electrically evoked compound action potential (ECAP) or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP, wherein the one or more parameters are adjusted when the patient is in a posture state and performs the aggressor movement.

2. The system of claim 1, wherein adjusting the one or more parameters includes disabling closed- loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

3. The system of any of claims 1 or 2, wherein the aggressor movement comprises a movement that results in reducing a distance between the lead and the user’s spine.

4. The system of any of the preceding claims, wherein the aggressor movement comprises at least one of the user coughing, the user moving a supine position, or the user arching the user’s back.

5. The system of any of the preceding claims, wherein the target stimulation therapy comprises a closed loop differential target multiplexed (DTM) therapy.

6. The system of claim 5, wherein the one or more parameters are programmed to keep a prime signal of the signal within a threshold window.

7. The system of claim 5, wherein the one or more electrodes are positioned at at least one thoracic vertebrae.

8. The system of any of the preceding claims, wherein the target stimulation therapy comprises subperception closed loop therapy.

9. The system of claim 8, wherein the one or more electrodes are positioned at at least one of thoracic vertebrae T9 or thoracic vertebrae T10.

10. The system of any of the preceding claims, wherein the data further causes the processor to: program the device without closed-loop stimulation when the one or more electrodes do not enable the target stimulation therapy and the target alternative stimulation therapy.

11. The system of any of the preceding claims, wherein the alternative stimulation therapy comprises at least one of an alternative closed loop DTM therapy or a alternative sub-perception closed loop therapy.

12. The system of any of the preceding claims, wherein the postures state comprises a supine position.

13. A neuromodulation system (100) comprising: a device (102) configured to generate a stimulation; a lead (104) configured to deliver the stimulation to a target anatomical region via one or more electrodes (110A, HOB); a processor(304); and a memory (306) capable of storing data thereon that, when processed by the processor, cause the processor to:receive target stimulation therapy data for a time period from the device, the device programmed with one or more parameters; determine whether the target stimulation therapy data satisfies one or more predetermined thresholds; adjust the one or more parameters for a first quadrant when the target stimulation therapy data does not satisfy at least one predetermined threshold of the one or more predetermined thresholds; receive a signal corresponding to the stimulation when a user performs an aggressor movement; and adjust the one or more parameters in a second quadrant when the signal corresponding to the stimulation when the user performs the aggressor movement does not include an ECAP or set one or more thresholds when the signal corresponding to the stimulation when the user performs the aggressor movement includes the ECAP.

14. The system of claim 13, wherein the data further causes the processor to: receive input regarding one or more troubleshooting steps when the one or more thresholds do not provide adequate closed loop stimulation control.

15. The system of claims 13 or 14, wherein adjusting the one or more parameters includes disabling closed-loop stimulation, and wherein the data further causes the processor to: enable the closed-loop stimulation.

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