Wearable neurostimulation system with curated therapy

Abstract

To provide a system and a method for providing curated neurostimulation so that a user is enabled to provide improved therapy in a home environment.SOLUTION: Stimulation protocols can be assessed to provide improved targeted stimulation of a nerve and less unwanted side effects. Sets of stimulation montages and associated weights are defined and are selected or adjusted in pre-defined methods, using pre-defined operations that simplify adjustment of characteristics of the stimulation field, such as geometry and location of the provided stimulation. Stimulation matrix pads are arranged and activated to provide advantages.SELECTED DRAWING: Figure 1a

Description

[Technical field]

[0001] The present invention relates to the field of stimulating biological tissue to improve the health or wellness of a user. [Background technology]

[0002] Stimulation of biological tissues can be used to improve health and wellness. Stimulation of peripheral tissues can induce changes at both peripheral and central sites in the treatment of disease or to promote wellness by regulating organ function. Stimulation of the vagus nerve is a good example of stimulation at a peripheral site in the neck, regulating brain and heart activity and resulting in systemic changes in immune and metabolic activity. Stimulation of cranial nerves does not require direct stimulation of brain tissue and can provide a relatively non-invasive treatment option for conditions such as headaches and migraines. Bioelectronic medicine is gaining increasing attention as a non-pharmaceutical treatment option for a variety of diseases.

[0003] Stimulation of peripheral sites to treat undesirable symptoms, medical disorders, and conditions, or to promote health or produce desired results in the brain or body is attractive because it can provide efficacy without the risks and invasiveness of directly stimulating organs such as the brain or heart. Targeted stimulation sites in the extremity regions, such as the arms, hands, legs, and feet, have been shown to be beneficial in treating a variety of disorders or ameliorating symptoms. Candidate sites can be stimulated and stimulation parameters and treatment schedules can be evaluated for medical benefit in individuals or populations of individuals diagnosed (or "self-diagnosed") with a medical condition. For example, undesirable symptoms or conditions related to: pelvic floor disorders; high blood pressure; digestive disorders; pain; immune or metabolic disorders or conditions, obesity; attention, mental or cognitive disorders; appetite; and other disorders, symptoms, or conditions that are typically treatable with medication can be treated with electrical stimulation with less risk of side effects or drug interactions. Stimulation of nerves in the legs, arms, or neck may provide a venue for the treatment of a wide range of common disorders, including cardiovascular disorders such as high blood pressure.

[0004] Stimulating nerves in the lower extremities offers the opportunity to treat disorders such as pelvic floor disorders, including urinary and fecal incontinence, which may manifest with urinary urge-related pathologies (e.g., overactive bladder or "OAB"). The inventors have shown that saphenous nerve (SAFN) stimulation for the treatment of OAB symptoms has many benefits compared to other potential peripheral neuromodulation targets (e.g., favorable sensation of stimulation, less impact from edema, stronger treatment response with fewer risks). Stimulating nerves in the legs using a wearable non-invasive nerve stimulator offers the advantages of successfully stimulating the target nerve while avoiding or reducing the risk of stimulating non-target nerves and / or tissues such as the calf muscles.

[0005] Systems and methods that allow easy control of stimulation field characteristics (e.g., shape, strength, orientation, position, perceived intensity, vector summation, etc.) would improve neuromodulation therapy and resulting treatment outcomes. Systems and methods are needed that allow easy adjustment of stimulation field characteristics and confirmation that they are set correctly. Operations related to selection, adjustment, and evaluation of stimulation field characteristics can be performed by the patient following instructions and providing feedback, by a medical professional in a medical clinic setting, by the user or caregiver in the home, or a combination of these (e.g., remote telehealth). The novel hardware and software controls and components, algorithms and logic flows, selection or evaluation of stimulation field characteristics, curated therapeutic support, and curated delivery and coordination of therapy regimen features such as scheduled therapeutic events provided by the digital ecosystem result in improved efficacy over existing therapies. Also disclosed herein are an easy onboarding process; instructional exercises and content; patient education regarding treatments and behaviors that can improve disease and symptoms; adherence prompts and trackers, and other novel features of the present invention. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application No. 2019 / 0126039 DISCLOSURE OF THEINVENTION [Problem to be solved by the invention]

[0007] It is an object of the present invention to provide improved peripheral nerve mobilization of target nerves using selective field steering achieved by systems and methods incorporating novel software and hardware solutions.

[0008] It is an object of the present invention to provide a set of weighting values ​​that are used to adjust the amplitude of stimulation provided to a set of stimulation channels to provide a smooth transition between the sets of stimulation channels.

[0009] It is an object of the present invention to provide a software-based artificial intelligence / machine learning program for obtaining and acting on user responses to establish improved stimulation protocol characteristics.

[0010] It is an object of the present invention to provide a system and method that allows adjustment of the position, geometry, depth of electrical field penetration, or other stimulation field characteristics, but without the subject experiencing undesirable jumps in the sensation of stimulation intensity that would interfere with the user's ability to make comparisons between a series of potential settings.

[0011] The objective of the present invention is to realize a strategy that incorporates: a) Nerve targeting that reduces the risk or amount of unwanted stimulation of collateral nerves or adjacent muscles; b) the use of weighting coefficients to allow the stimulation field to be adjusted without producing abrupt transitions in the intensity or perception of the stimulation; c) Providing a sensory masking stimulus that allows a preferred sensory experience and / or reduces discomfort.

[0012] The objective of the present invention is to provide improved neural targeting by guided adjustment of a set of stimulation field parameters and to avoid stimulating unwanted tissues such as calf muscles, shin bones, cutaneous nerves and branches, which can be uncomfortable and even dangerous for some users (e.g., outpatient users, as this can cause muscle tension, tearing, or loss of control).

[0013] The objective of the present invention is to configure stimulation parameters to provide stimulation at cutaneous nerve fiber types or receptor types (mechanoreceptors, thermoreceptors) and process modalities such as touch, pressure, vibration, temperature, etc. to act as a sensory mask.

[0014] An object of the present invention is to configure stimulation parameters to reduce unwanted stimulation of cutaneous nerve fibers and receptors (eg, pain nociceptors) by targeted nerve stimulation.

[0015] It is an object of the present invention to provide adjustable tuning levels for a stimulation field controller, including at least two levels of tuning characteristics, such as "coarse" and "fine", that can be selected by the user.

[0016] It is an object of the present invention to provide at least one stimulation modality that provides an auxiliary stimulation signal (also called a "distractor" or "mask" signal) before or during therapeutic stimulation, where the mask signal serves to improve the subjective experience of the stimulation, reducing the sensation of pain and / or increasing stimulation tolerance, allowing a larger stimulation signal to be delivered without the user experiencing pain or discomfort.

[0017] An object of the present invention is to provide at least one stimulation modality that provides a stimulation mask simultaneously with a therapeutic stimulation signal, where the stimulation mask is provided by an adjacent electrode at an intensity level lower than the intensity level provided by the primary channel of stimulation.

[0018] It is an object of the present invention to provide a system and method that allows for the selection of an improved stimulation montage for stimulating a target nerve.

[0019] An objective of the present invention is to incorporate "protected" or "blocked" stimulus montages and user controls that allow the user to adjust the stimulation by gestures on a touch-sensitive display to focus or limit the stimulation field or to avoid stimulating areas.

[0020] It is an object of the present invention to combine anode and cathode assignments to stimulation pads to create a stimulation field that increases the depth of stimulation from the skin surface.

[0021] The objective of the present invention is to combine anode and cathode assignment to stimulation pads to selectively modulate target tissue (e.g., arm muscles when stimulating other nerves, calf muscles, neck muscles, or arm nerve targets to modulate cardiac properties such as blood pressure) while avoiding tissue areas that cause undesirable side effects.

[0022] It is an object of the present invention to provide a curated "Restore" neurostimulation therapy guidance program that guides the user through a scheduled therapy program over predefined intervals.

[0023] It is an object of the present invention to provide a curated "Maintain" neurostimulation therapy maintenance program that guides the user through a scheduled therapy program.

[0024] The objective of the present invention is to provide remote or software-based coaching (e.g., behavioral therapy or nutrition education) and to provide education and survey items tailored to educate, survey, evaluate, track, and adjust treatment on an individual basis, as well as adjust these based on user behavior and input (e.g., change in symptom scores compared to baseline scores).

[0025] The objective of the present invention is to combine stimulation therapy with behavioral therapy (e.g., guides and prompts related to times to eat, drink, exercise, etc.), nutritional information, and other guidance and information to improve the overall effectiveness of treatment.

[0026] It is an object of the present invention to provide a medical disorder treatment configured for at-home guided treatment of a user with little, if any, supervision by a medical professional or with scheduled remote medical supervision provided by a medical professional. [Means for solving the problem]

[0027] These and other objects of the present invention are disclosed in the remainder of this application. [Brief description of the drawings]

[0028] FIG. 1a illustrates a neurostimulator system including a neurostimulator, a stimulation matrix of stimulation pads, a wearable wrap, and a user device having a user interface screen that controls stimulation parameters. FIG. 1b shows a neurostimulator with a control unit, a display unit, and a port. FIG. 1c shows a wrap with a directional keyed opening, a neurostimulator (bottom view), and an interface guide with directional keyed connectors for the stimulation matrix and neurostimulator. FIG. 2 shows modules of a neurostimulation system implemented in the neurostimulator and a user device including a remote server computer of a telemedicine service or clinic. FIG. 3a shows an embodiment of the stimulus matrix. 3b-3f show exemplary user interface screens for controlling the stimulus montage in which the stimulus matrix is ​​provided. 4a-4e show various stimulus matrix design embodiments. 5a-5j show embodiments of user interface screens for enabling selective user adjustment of stimulus field characteristics of the stimulus matrix. 6a-6n show embodiments of different activation montages provided by the stimulation matrix, where the anode ("A"), cathode ("C") are active (unshaded) or inactive (shaded). 7a-7c show a stimulation matrix embodiment including a set of four-sided stimulation pads. 7d and 7e show a stimulus matrix grid array with eight rows of pads. FIG. 8a illustrates how a set of stimulus montages is used to establish therapeutic stimulation. FIG. 8b illustrates a method for providing onboarding, induction, and maintenance according to defined features for a curated treatment regimen. FIG. 8c illustrates how treatment can be managed to prevent possible skin events and promote good skin health according to user preferences and a risk score in the user profile. 9a-9k show exemplary user interface screens of a digital ecosystem that guides, informs and captures user input as part of a curated treatment program for disorders such as pelvic floor disorders, and more specifically OAB. 10a-10k show additional examples of user interface screens of a curated treatment program of a digital ecosystem that allows user control of stimulation, as well as screens related to behavioral coaching and education. FIG. 11 shows the results of a long-term study of efficacy after 6 and 12 months of treatment supporting an induction period of more than 21 days for OAB treatment with daily stimulation of SAFN. FIG. 12 is a schematic diagram showing a protruding flange extending from a support ring or push nut that is adhered to a stimulation pad. BEST MODE FOR CARRYING OUT THEINVENTION

[0029] Although specific embodiments may deviate, the following terms generally mean the following: Subject, patient, or user are used interchangeably. A user is a medical technician who stimulates themselves at home or controls the neurostimulator in a clinic, a caregiver, or a medical professional who remotely controls the neurostimulator using the Internet or wireless communication channels (e.g., WIFI or cellular networks). A user may not be the person receiving the treatment. A subject may refer to a participant in a research study. The anode and cathode represent the initial phase of a biphasic pulse. When a biphasic stimulation signal is used, the anode and cathode designations may be switched during delivery of the stimulation signal, but this designation represents the stimulation circuitry supplied by at least two channels of the stimulation generator. A stimulation pad is a conductive substrate that is applied to the patient's skin and used to provide an electrical stimulation signal (also called a "conductive pad" or "electrode"). A stimulation channel is an electrical pathway that terminates at a stimulation pad, and for purposes of this disclosure, may also be considered to be a portion of at least one active stimulation pad that functions as a cathode or anode or an inactive pad. If stimulation is provided by other modalities, each individual transducer for magnetic, sonic, vibration, or other type of energy may be considered a stimulation channel. The stimulation circuit is at least one cathode and an anode. The primary stimulation circuit / channel refers to the channel that provides the highest amplitude signal, and the stimulation matrix (or "matrix") is a set of three or more conductive stimulation pads that function as an "electrode array" to provide transcutaneous electrical stimulation. The "strength," "amplitude," and "intensity" of a stimulation signal may generally be used interchangeably, however, it is understood that the perceived intensity may be increased in other ways, such as by increasing the pulse duration and increasing the total charge delivered. The horizontal "x-axis" or "left-right" axis of the stimulation matrix typically spans the entire limb, while the proximal-distal axis (i.e., "vertical" or "y-axis") coincides with the axis of the user's limb. When fixed on the left leg, "left" is closer to the shin and right is closer to the calf muscles, and vice versa for the right foot. Typically, the horizontal and vertical adjustments are orthogonal. When there are both horizontal and vertical offsets between channels, they are "diagonal". The rows and columns of the stimulation matrix refer to stimulation circuits defined and distributed generally horizontally or vertically. Stimulus matrix geometry refers to the arrangement of activated pads on the stimulus matrix and the spacing between the pads, and may also refer to the shape and size of the individual pads. The stimulation protocol defines the stimulation signals to be sent to each channel of the stimulation matrix that result in the stimulation montage and the stimulation field characteristics produced by the stimulation matrix. It also refers to the characteristics of the scheduled stimulation sessions (e.g., the timing and duration of scheduled treatment sessions). The stimulus montage includes the designation of each stimulation pad of the matrix (anode, cathode, inactive, etc.) and the weights used for each channel (usually to scale the amplitude, but can also affect other waveform parameters such as pulse width). The stimulus montage is the part of the stimulation parameters that defines the signal delivered by the matrix (active geometry + stimulation signal). The stimulus montage provides the profile of the activated pads of the stimulation matrix. The stimulation field geometry is the shape of the vector electrical field that is induced within the user's body. Nerve "recruitment" and "modulation" refer to the influence of an electrical field on neural activity, usually affecting neural activity by initiating action potentials. The skin stimulation threshold is a stimulation sufficient to cause a sensation of stimulation in the skin area beneath one or more stimulation pads. The target nerve threshold is a stimulation sufficient to cause recruitment of the target nerve as evidenced by the perception of paresthesia moving away from the stimulation pad, or in an area distinct from the stimulation pad, or by a sensory or motor response evoked by the stimulation. The therapy regimen includes the stimulation protocol and all defined therapeutic manipulations / events to be delivered as part of the therapy. The Non-Invasive Neuromodulation Assistant (NiNA) System refers to the functionality enabled by a combination of hardware, software, and a digital ecosystem that work together to provide the neurostimulation therapy and benefits of the disclosed invention.

[0030] Wearable Neurostimulation System FIG. 1a shows an embodiment of a neurostimulation system 10 including a neurostimulator 12 that electrically and physically connects to a stimulation matrix 14 having stimulation pads 16 that are removably attached to the skin of a user and deliver electrical stimulation signals therethrough. The device 12 and matrix 14 can be secured in position on a user's limb (e.g., a lower limb) using a garment such as a wrap 18. The wrap 18 is designed with a long arm 18a, a short arm 18c, and a base region 18b therebetween that is configured to engage with the device 12. The user device 20 is realized as a smartphone running Android or iOS and operating a mobile app 21 that allows the user to communicate with and control the neurostimulator 12. Control of selected treatment parameters may be constrained according to the permissions allowed by the curated therapy regimen, which may be adjustable or predefined limits. The stimulation generation electronics of the stimulation module of the device 12 provide stimulation under the control of the device's control module, providing stimulation signals to the stimulation matrix 14 during treatment. In one embodiment, the stimulation circuitry of the device 12 provides independent current-controlled stimulation channels, such that each stimulation pad 16 of the stimulation matrix 14 functions as a cathode, anode, and passive ground return. Each pad has its own power source, allowing precise control at each pad, resulting in the actual stimulation field being provided and maintained as specified.

[0031] In one embodiment of the neurostimulation system 10, a stimulation module 42 is provided having an electrical stimulation generator therein that transmits electrical signals through a number of electrical generator channels. A control module 40 is electrically coupled to the electrical stimulation generator to activate or deactivate each of the electrical channels according to a predefined protocol having at least two sets of stimulation montages with defined weighting values ​​for each set of activated pads (seen in FIGS. 6a-6n).

[0032] A first stimulation montage (any one of the stimulation matrices 14 shown in FIGS. 6a-6n) is defined for the stimulation pads 16 of the stimulation matrix 14, with each of the electrical stimulation pads 16 being in an active or inactive state. At least one second stimulation montage is defined for the electrical stimulation pads 16 of the stimulation matrix 14, with at least one of the electrical stimulation pads 16 being in an inactive state when at least one stimulation pad 16 is in an active state in the first stimulation montage. The user interface device 20 allows a user to transition the stimulation matrix from the first stimulation montage to the second stimulation montage.

[0033] Although the objective of the present invention is to selectively target the saphenous nerve (SAFN) for the treatment of overactive bladder (OAB), in alternative embodiments, any nerve (or combination of nerves) in the leg, particularly the lower extremities below knee level (e.g., saphenous, sural, posterior tibial, tibial, peroneal) may be stimulated to treat a variety of conditions and disorders. The present invention may also be used to stimulate other limbs or body parts, such as at least one arm of a user.

[0034] 1b shows an embodiment of a neurostimulator 12 having a housing formed as a durable plastic enclosure containing the electronics and power source. The upper housing portion 24a has a power button 22 and stimulation field controls that allow the user to adjust displays such as a touch sensitive display 30 that provides information on stimulation amplitude 26a, 26b and location 26c, 26d, stimulation field amplitude 30a (or "strength") and location 30b, and other information 30c (e.g., time elapsed / remaining in a treatment session, battery level, number of stimulation sessions remaining, or number of days until matrix 14 needs to be replaced). Housing 24 also has at least one port 32 that allows for the exchange of data / power signals, which can be configured to accept a connector with a series of electrical channels / contacts (USB, Lightning cable connector, pogo pins with magnetic retention, etc.) and have a corresponding set of electrical channels / contacts that send signals to a module (e.g., a power, transmission, or control module) of device 12 and can enable wired control or data / power transmission to and from device 12.

[0035] The device controls allow the user to start, stop, and pause stimulation by causing corresponding operations in the control module. For example, after a therapy session has begun, pressing the power button 22 for about 1 second will pause or resume stimulation, while holding the button 22 for longer (e.g., 2 seconds) will cause a shutdown operation (e.g., updating the device memory and then turning it off or setting it to a power-saving standby mode per step 132 in FIG. 8b) or pressing buttons 26a, 26b will perform "field controls" 26c, 26d that can increase or decrease the amplitude of the stimulation pulse or change the characteristics of the stimulation field, such as the position. Field control improves capture of the target nerve (e.g., SAFN) while minimizing stimulation of the surrounding nerve and muscle tissue (i.e., nerve targeting increases selective activation). Field control has advantages such as eliminating the need for trial-and-error methods of stopping stimulation, repositioning stimulation pads, and resuming stimulation. The touch-sensitive display 30 can indicate stimulation field characteristics using either graphical or text-based information, providing a simple user interface as well. The characteristics include, for example, information regarding stimulation intensity 30a, position / geometry of stimulation montage 30b, and other information 30c (e.g., stimulation status off / on / paused, time remaining). The neurostimulator 12 can also operate additional input / output accessories (I / O components, sensors, or transducers) such as a camera 38a that allows the neurostimulator 12 to scan and track relevant information on other system components (e.g., barcode information on a disposable stimulation matrix) or take pictures of potential skin problems. Another I / O component is a speaker 38b that can provide auditory cues related to the therapy operation (e.g., providing a tone if the stimulation matrix is ​​not installed correctly).

[0036] 1c shows an embodiment with a garment such as a leg wrap 18 realized as a flexible / fabric wrap that secures the neurostimulator 12 and stimulation matrix to the user's upper calf during treatment. The bottom housing 24b of the neurostimulator 12 is comprised of a molded (or "keyed") device connector 34a that engages (physically and electrically) with a molded matrix connector 34b provided on the top surface of the stimulation matrix to secure both connectors together and through the wrap 18 in the intended orientation. The neurostimulator 12 includes a stimulation module having signal generation circuitry for delivering electrical stimulation pulses to the pads of the stimulation matrix via electrical channels / contacts 35a, 35b (not shown) of the connectors 34a, 34b to provide multiple independently controlled stimulation channels. Each channel of the set of channels / contacts 35a of the molded connector 34a of the neurostimulator 12 can be connected to or dynamically routed to one or more channels of the signal generation circuitry of at least one pulse generator of the neurostimulator. Thus, the stimulation pads of the matrix can be independently controlled to provide selected stimulation signals and to be active (e.g., anode, cathode) or inactive.

[0037] In an embodiment, the connectors 34a, 34b are asymmetrically shaped to only allow engagement with a predetermined physical orientation. A keyed connection between the device 12 and the matrix 14 is established through a keyed opening in the interface guide 33, and a magnet 36 can be used to form a magnetic connection between the matrix and the neurostimulator device. The magnets 36 on the two halves 34a, 34b of the connector assembly allow them to "snap" together when properly aligned, providing a secure connection between the corresponding conductive channels 35a, 35b. The keyed connector is arrow-shaped to provide an intuitive user perception of up direction (e.g., when worn on a leg, the arrow points up). Thus, the "female / lock" portion of connector 34a forms an "arrow" contour that matches the corresponding "male / key" shaped connector 34b of the matrix and the corresponding shaped opening in the wrap. The connector 34a at the bottom of the neurostimulator 12 housing, the connector 34b at the top of the array, and the opening in the interface guide 33 of the wrap 18 are all aligned to allow for proper application of these three system components during treatment.

[0038] In an embodiment, the molded connector 34a and electrical channels / contacts 35a are also configured to connect to a custom adapter (not shown) for the transfer of power / data signals to and from the user device 20 connected to the cable. Some of the electrical channels / contacts 35a are configured to send signals to a power module or a transfer module of a neurostimulator device. In other words, the connector 34a connectable to the stimulation matrix may also have contacts that allow it to function as a system interface for charging or transfer purposes.

[0039] In an embodiment, the molded connector 34b of the matrix has electronics to provide functionality such as a readable unique ID 37 (see FIG. 3a). The unique ID 37 can be achieved using a microchip or RFID chip embedded in the connector 34b that uniquely identifies each stimulation matrix (e.g., by serial number) to the neurostimulator device using wired (e.g., via connector 34a) or wireless (e.g., RFID) means. Alternatively, the matrix may have a unique ID 37 displayed as a barcode or QR code 37A (see FIG. 3a) that is read by an I / O component 38, such as a camera 38a, of the neurostimulator (see FIG. 1b) or user device 20. The ID information can be manipulated by the neurostimulator or can be sent from the neurostimulator to a user device where it is processed by a system module (e.g., evaluation-management module 46 in FIG. 2). As described in FIG. 2, the ID information 37 can be processed by software in a user interface module 48 and manipulated by the evaluation-management module 46 to determine whether the matrix meets compliance criteria in a matrix management module 49, such as whether the matrix usage is less than the maximum allowed number of therapy sessions or cumulative stimulation time.

[0040] Connective Wrap In an embodiment, the system uses a flexible, stretchable fabric wrap 18 with a base region 18b and two tapered wing regions 18a, 18c or "arms." The base region 18b includes an interface guide 33 having a rigid frame that includes shaped openings that allow molded connector portions 34a, 34b to engage. The wrap, interface guide, and molded connectors work together to: Proper use is facilitated by a) correctly positioning and orienting the neurostimulator and matrix (when stimulating the SAFN, the matrix should be placed on the medial surface of the leg and on tab portion 52, and if provided on the matrix, should be placed on top with the neurostimulator display having the intended orientation for displaying information to the patient); b) securing the matrix and device to the patient's leg during treatment; c) providing adjustable, appropriate and comfortable pressure against the skin; and d) providing unobstructed access to the device display and user controls.

[0041] As shown in FIG. 1a, in one embodiment, the wrap is sandwiched between the matrix 14 and the device 12. It is then wrapped around the patient's upper calf so that the matrix is ​​positioned over a portion of the user's SAFN. Velcro or similar attachment material can be used to secure the arms 18a, 18c together. Adjustable straps can also be provided on the arms of the wrap to allow the user to adjust the tightness of the wrap 18. The shape of the wrap can be important because the SAFN is a sensory nerve rather than a motor nerve that is selectively or primarily stimulated during treatment. Thus, the patient should be able to engage in ambulatory activities without worrying about unwanted movement or muscle damage. In an embodiment, the wrap is oriented and biased such that its upper and lower edges are asymmetrical to improve fit. For example, the bottom is shaped with a steeper angle at the lower end that engages the calf muscle area than the proximal end to better conform to the shape of the leg and calf muscle. The improved fit around the user's calf provides support and reduces the risk of improper fit and migration when the patient is ambulating during treatment. The wrap 18 can be formed of known biocompatible materials (e.g., blends of polyester and other breathable fabrics such as lycra, spandex, elastane, stretch yarns, etc.). In an embodiment, the wrap is formed from 1-4 layers of material to produce a stable or moderate stretch (e.g., 0-100% stretch) end result, which can be achieved using weaves or other designs that allow for two-way or four-way stretch.

[0042] In another embodiment, the wrap 18 can be realized as a flexible substrate having conductive stimulation pads (e.g., dry or reusable electrodes) on the bottom surface that are connected to a neurostimulator and adapted to apply stimulation to the user's skin. Rather than a wrap, the system can be used with clothing such as a sock form factor with conductive areas.

[0043] Neurostimulation System Components and Modules 2 illustrates an embodiment of components and modules of the neurostimulation system 10a. The modules may be implemented within the housing of the neurostimulator 12, and within other system components such as the matrix 14, wrap 18, and user device 20. The modules include software (computer code), algorithms and rules, hardware / electronic circuitry, user interface components (e.g., transducers and transceivers), and other resources necessary to provide the functionality attributed to the module that enables the system 10a to function. Modules may be implemented and share resources in a distributed manner across two or more components of the system 10a. For example, the user interface module 48 of the neurostimulator 12 or the user device 20 can accept user input, manipulate the input, and communicate the output of the manipulation to the other device, such that both devices of the system 10a work in concert to provide the intended therapy. Rather than implementing the electronics (e.g., stimulation generation, control, and / or routing circuitry) within the neurostimulator housing, the electronic assembly can be mounted on top of the stimulation matrix, connected to the neurostimulator housing, and controlled by a processor in the control module 40 of the neurostimulator 12. Thus, the modules disclosed as being present within the neurostimulator housing can generally be implemented in at least one of the user devices 20 or other system components.

[0044] The control module 40 of the neurostimulator 12 has a processor for executing computer code instructions related to therapy delivery and device operation. It is understood that the control module also contains timers, real-time clocks, memory, and incorporates circuitry commonly available and well known to be present in consumer electronic devices such as smart phones, health tracking wearable devices, and devices commonly used to deliver electrical stimulation to users at home and in clinics. The control module 40 also contains all the therapy parameters and protocols, schedules, algorithms, and rules used to deliver one or more curated therapy programs. In an embodiment, the control module 40 is configured to implement multiple functions in the treatment regimen that enable a user-friendly experience when using the system 10a. Functionality relating to a curated on-boarding experience, user training, scheduled treatments, user-friendly adjustment of stimulation protocol parameters to provide a perception of improved neuromodulation and stimulation, coaching, education, supportive activities (as well as other functionality to be disclosed) is enabled by the digital ecosystem.

[0045] The power module 41 has a rechargeable power source that allows multiple uses between recharges, or may have a primary battery or a combination of the two. Recharging can occur through port 32, via an adapter through connector 35a, or using wired recharging provided by the wireless inductive charging circuitry of the power module 41. The power module also has power management, safety, isolation, and monitoring circuitry to provide power related operations.

[0046] The stimulation module 42 includes one or more stimulus generators having circuitry for generating one or more channels of stimulation for providing a stimulation signal according to a stimulation protocol. The stimulation module 42 includes circuitry for enabling impedance measurements and for conditioning the signal in relation to the measurements. The modules contain processing circuitry (e.g., analog and digital signal conditioning modules, filters, amplifiers, DA / AD circuits, memory, clocks and timers, switches, and multiplexers) for stimulus signal generation and control. In an embodiment, one or more signal generators are configured to control the stimulation provided to each of the stimulation matrix pads, such that each of the plurality of stimulation pads 16 is independently assignable to be active (e.g., anodal or cathodal) or inactive. The stimulation module is configured to provide stimulation signals to the active stimulation pads according to a stimulation parameter protocol.

[0047] In an embodiment, where the stimulation matrix has six stimulation pads, the module allows each of the six pads to operate as a programmable, selectable electrode according to parameters defined in a stimulation protocol. Multiple stimulation generators allow independent control of multiple stimulation signals that can be provided simultaneously or alternately. The characteristics of the multiple channels of stimulation can be controlled to provide field steering capabilities. The stimulus generator can use constant current and constant voltage stimulation circuits. The stimulation circuitry of the stimulation module 42 and the sensing circuitry of the sensing module 44 can be connected to any of the stimulation matrix pads via channels 35a of molded connectors 34a on the bottom surface of the device housing 24b.

[0048] The stimulation module 42 provides user-friendly and easy adjustment of stimulation protocol parameters that affect the location and shape of the stimulation field using NiNA's "SaphLocate" function as will be described, including some of the following: a. The stimulation module 42 also includes a set of defined stimulation montages, including channel assignments (anode, cathode, inactive) and channel weighting values ​​(which may be based on the amplitude of the electrical signal transmitted by the electrical stimulation generator, as well as other parameters such as pulse duration, frequency, etc.), used to adjust the stimulation signal provided by each stimulation channel (i.e., at each stimulation pad). This may include a table of channel weighting values ​​(also called "weighting coefficients" or "weighting values") used to adjust the stimulation signal provided to the user via each stimulation channel. b. The stimulation module 42 also includes separate sets of defined stimulation montages to be selected a) when the user is evaluating different stimulation montages during training or evaluation, which may occur prior to providing therapeutic stimulation, and b) when the user is providing stimulation therapy during treatment. This module also includes sets of defined stimulation montages for "coarse" or "fine" resolution adjustment. c. The stimulation module 42 also includes a set of defined stimulation montages to be used in succession when the user adjusts the stimulation field in a defined direction (e.g., left-right or proximal-distal). The module also includes algorithms or rules for accessing look-up tables that define how to adjust or select the stimulation montages according to user input using circuitry that allows for field steering control or similar adjustments. The module is configured such that adjustments of the stimulation montages are made according to a predefined sequence of stimulation templates. The selection or adjustment of at least one stimulation field characteristic defined by the stimulation template can include, for example, a) stimulation field position, field spread, and field attenuation, as disclosed.

[0049] In an embodiment, the signal generator of the stimulation module 42 is configured to provide stimulation signals including pulse trains, bursts, sinusoidal waveforms (0.1 Hz to >50 kHz), arbitrary waveforms, band-limited noise (narrowband or wideband), estimated electrical stimulation provided using multiple channels of stimulation montages to provide targeting functions.

[0050] The memory module 43 manages the storage and retrieval of data created or used by other modules of the system, such as managing or retrieving log data (generated by the log module 50m), storing instructional and behavioral coaching, a library of video content used to provide educational content (used by the reference material module 50b), and reference information accessed or manipulated by various modules of the ecosystem module 50. This module provides database functionality and manages lookup tables for other modules to store and retrieve values ​​associated with stimulation parameters, treatment protocols, user-defined parameter values, and inputs such as survey responses and user preferences. The memory module can also manage content that is stored and updated on a web storage resource (i.e., the "cloud") or on a remote computer 20f.

[0051] The sensing module 44 includes circuitry for operating sensors such as accelerometers, electrodes, etc. capable of sensing impedance or physiological measurements that can be sent to the assessment and management module to assess measurements such as heart rate, evoked nerve potentials (e.g., evoked compound action potentials "ECAPs," sensory nerve action potentials "SNAPs," etc.), or evoked EMG responses. It may also include optical sensors (e.g., for measuring heart rate or blood oxygen levels), sensors for obtaining data related to hydration, skin temperature, or for deriving cardiac measurements such as blood pressure.

[0052] The communication module 45 provides all the circuitry and software algorithms necessary for the system components to communicate with each other or with other devices. For example, the system components shown in Figure 2 include a set of user devices 20 that can communicate with the neurostimulator 12 to enable user control of stimulation therapy. This module contains circuitry and operating procedures that allow system components to "handshake" and communicate reliably and wirelessly using Bluetooth, WIFI, and other wireless protocols. In one embodiment, the communication module updates the contact log in the log module 50m based on communications between devices.

[0053] The Evaluation-Management (EM) module 46 includes protocols for evaluating the sensed data, such as a) deriving evoked potential data (e.g., operating signal processing algorithms to derive measurements of averaged SNAP data), and b) evaluating accelerometer or EMG data to determine the user's state or activity level (walking, running, sleeping, lying down, etc.). The EM module 46 is also configured to operate the memory module 43 to store a log / history of device operation including duration, intensity, and other parameters used during stimulation, sensed patient activity level or location, etc. The module can also manage device operation by evaluating the impedance sensed by the sensing module 44 and acting according to "improper impedance" rules if the impedance measurement does not meet the impedance criteria. The defined actions can include, for example, setting a flag in the control module 40 to pause stimulation and / or providing a user warning (by controlling the stimulation module 42 and / or the user interface module 48).

[0054] The progress module 47 tracks the user and their progress in achieving their goals. For example, the module includes an algorithm that uses responses to a survey presented by the digital ecosystem module 50 to calculate the user's initial symptom score at baseline (e.g., calculated using data taken over three days before and after starting treatment). The user is surveyed again at a date one or more days later (e.g., day 14) and the results are used to calculate at least one post-treatment symptom score and at least one difference score comparing the baseline and post-treatment scores. If one or more symptom scores show improvement between the first and subsequent scores that exceed a selected threshold, a defined action occurs, such as the module might display a treatment progress message: "Congratulations: Your urge incontinence score has decreased by x%." This module calculates and stores scores at various time points, upon user request or according to users who have achieved symptom improvement in scores above a minimum threshold, calculates the change in score compared to the baseline, and displays these to the user as a score history or trend line at pre-set times.

[0055] The progress module 47 functions as a progress tracker that tracks and displays to the user information regarding symptom change or progress relative to completion of treatment. A graphical display of the steps required for diagnosis and / or treatment can show the user their status within a defined course of treatment. For example, the timeline may include one or more time points for initial consultation, completion of a baseline bladder diary or survey, telehealth diagnosis and prescription, onboarding, induction intervals, potential transition to maintenance, scheduled telehealth or clinic visits, and other defined therapy events.

[0056] The user interface module 48 provides subroutines and algorithms for operating and responding to the user interface (e.g., controls and display) provided in the neurostimulator 12 or the housing of the user device 20. This module manages user navigation through the various menus and treatment screens of the user device 20, selection of features provided by the digital ecosystem module 50, and entry of user input data. The module controls the information presented to the user on the display at a particular time (e.g., it can alternate between stimulation intensity and a timer value indicating the time remaining or elapsed of a treatment session). The module also assists in processing, adjusting, updating, and synchronizing operating parameter values ​​in response to user input commands of a user interacting with the neurostimulator 12 or user device 20. The user controls 26 and display 30 of the neurostimulator 12 (shown in FIG. 1b), as well as the touch-sensitive display of the user device 20, are part of a user interface module 48 and allow user adjustment of stimulation protocol parameters (e.g., intensity controls 26a, 26b, stimulation amplitude via field steering controls 26c, 26d that provide spatial adjustment of the stimulation field along at least one axis of the stimulation matrix). Some of the information presented by the module include a) remaining session time, b) stimulation intensity, c) stimulation field position in at least one axis, and d) remaining battery life. A touch-sensitive display also allows user input to be provided to control therapy characteristics.

[0057] In an embodiment, the user interface module 48 provides the user with voice prompts for a series of survey items such as "Did you leak today?" that require simple user responses to be selected, entered or spoken on the display of the user device 20, recorded, transcribed, interpreted, and possibly confirmed (i.e., repeated back to the user) and added to a log. The user input / feedback provided by the user is used to modify the therapy regimen. The user's verbal responses may be limited to one or two word answers such as numbers (e.g., 1-10), or simple answers such as "yes," "no," "large," "medium," and "small."

[0058] The matrix management module 49 provides the system with functions related to the identification and use of stimulus matrices. This includes the date the matrix was replaced and the time or number of times the matrix was used. It includes protocols for obtaining and verifying matrix ID information using a verification algorithm that may also utilize a lookup table, or by communication to and from a remote computer 20f.

[0059] The Digital Ecosystem module 50 enables the system to provide additional operations related to user surveys, treatment coordination, promoting and assessing adherence, remote telehealth capabilities, and patient education and behavioral training that complement or enhance the efficacy of the stimulation therapy and additional functionality of the next ecosystem module.

[0060] The virtual module 50a includes resources to support virtual or augmented reality features of the system, such as those that can assist a user in aligning a wearable device to a similar body part for another treatment session. For example, when a user points the video camera of the user device at a leg, the software can superimpose a virtual device on the user's leg according to a previous placement that is known to be correct. The modules may also include modeling software to aid in the visualization of modeled stimulation fields that can be presented to a user. For example, the modeling software performs calculations of the stimulation signals provided by the channels of a stimulation matrix and generates modeled vector stimulation fields that can be displayed graphically to a user (e.g., via a "heat map" display of current density or other field parameters). In addition to simply indicating the strength of the stimulation signal at each stimulation pad, the modeling software may also use information about impedance, active / inactive channels, pad shape, and matrix geometry when calculating the vector field that is displayed to the user. Virtual module 50a also includes software that allows the user to select one or more regions of an anatomical representation of the user's body (e.g., tapping an area on the user device display) to indicate, for example, the lowest area where paresthesia is felt (FIG. 9h).

[0061] The reference module 50b includes reference materials, videos, and other content that are presented to or accessed by the user during intervals defined by the treatment regimen. This module also stores information such as photographs taken by the user. For example, when the system is initially set up for a user by a physician, part of the onboarding process is defined in the onboarding module 50e to operate the digital camera of the user device to capture a photograph of the user wearing the neurostimulator 12. The user is prompted to view, or by the user device 12 to view, this reference image before providing a treatment session at home to reinforce correct leg alignment.

[0062] The user group module 50c includes resources to support users interacting with groups of individuals who also use the neurostimulation system, including, for example, message boards and chat access. Progress of other users who started simultaneously with a particular user can be provided as a means to gamify the treatment experience.

[0063] The telemedicine module 50d includes telemedicine functionality including scheduling and connecting to remote medical assistance to provide video conferencing or other remote assistance (e.g., chat). The telemedicine software may link to the user's smartphone calendar to allow setting dates for events on a treatment regimen, including telemedicine dates. In one embodiment, the system includes computer readable software code in a user interface module that operates in conjunction with other modules to manage telehealth operations and create a corresponding data log of a user's remote telehealth history. In addition to the schedule, remote consultations can occur depending on the user's answer input when surveyed for any questions related to treatment. When a scheduled treatment session is set to occur, the app can provide a "push notification" where the user is asked if they want to do a remote session or schedule an appointment (via the scheduler or phone). If they respond affirmatively, a schedule screen is called up and the user can select a date and time to start the remote session, including immediately.

[0064] The onboarding module 50e operates to guide, train, survey, and assist the user during initial use of the system to set user preferences and establish a user profile. In an embodiment, the module provides a curated progression through a series of interactive screens, including instructions and actions for proper system use, surveying the user about treatment goals, user information (e.g., age, coping strategies, etc.), user symptoms, user preferences, medical history, etc. The onboarding information is then used to create a user profile and adjust treatment protocol parameters.

[0065] The survey module 50f manages the scheduling and selection of survey items presented to the user during onboarding, induction, and maintenance treatment intervals. Surveys may be conducted using, for example, a) event-driven rules (e.g., if the user indicates improvement in a subjective quality of life (QOL) measure, the system may offer further survey questions to obtain more information), b) logical rules (e.g., if the user indicates that nocturia is not a problem, the user will not be further surveyed on that topic in the future), or c) scheduled rules (e.g., a two-week time point is reached and a post-treatment assessment should be conducted).

[0066] The user profile module 50g provides storage and management of user profile information.

[0067] The coaching module 50h provides patient coaching and allows for selection and adjustment of coaching schedules, where coaching includes modifying a user's behavior, cognition, or other attributes to help provide improved outcomes. Coaching can include providing educational content, reminders, and "nudges" related to information relevant to the patient's treatment (e.g., neurostimulation or cognitive / behavioral therapy). The coaching module can be designed to prompt the user before each home therapy session to take photos to create a visual log, which can be reviewed by a medical professional to ensure the user is positioning the device correctly.

[0068] The alert module 50j stores protocols and parameter values ​​used by user notification operations to promote compliance with stimulation therapy sessions or other therapy events.

[0069] The Locator / Connect Module 50k provides functionality related to locating physicians familiar with SAFN therapy and includes information such as physician profile, distance from the patient's location, patient ratings and comments, contact information, and the ability to schedule appointments or remote sessions (or access remotely). It can also filter information based on patient insurance information and preferences (male / female physicians, alternative medicine specialty, primary care vs. urology, etc.).

[0070] The log module 50m is configured to create a log of all dates, times, and parameters associated with treatment delivery, device operation, or user input. The log may include time-stamped data that allows a user to interact with the AE module 50n, for example, to create and store a photo-log to identify and track potential skin conditions ("skin events") associated with device use. Algorithm support for assessing the condition over time allows for evaluation of image features related to the severity of the skin condition. Fields in the contact log may include the time and content of any user messages the user may send to or receive from the remote computer 20f of the remote medical service. The contact log can also store information related to user-provided "event tagging," which may include voice recordings or text messages that are sent to a remote computer 20f for review or stored on the device for later uploading and review by a medical technician.

[0071] The Adverse Event (AE) module 50n is configured to provide the user with functionality related to identifying, reporting, recording, tracking, and avoiding potential adverse events that may be associated with treatment, such as skin reaction events (e.g., redness, pain, bruising, etc.) For example, if during the onboarding process the user indicates that their skin is prone to irritation, the module can set a reminder to occur before a treatment session and instruct the patient to alternate the leg on which the device is worn, limit treatment to a selected period of time, apply a moisturizing cream after a session, etc.

[0072] The rules / algorithm module 50p is accessed by the control module 40 to store and implement the rules and algorithms of the system 10a. A rule defines what will occur if an operational parameter is set to a particular value. For example, if a skin risk score variable is set to a defined value, a skin risk action will be provided by the treatment program. Rules can optionally implement actions based on achieving or exceeding various thresholds. The algorithms are used to calculate results that guide system operation. The rules can also access actions defined in a lookup table of defined events to provide the user with the appropriate therapy event. Once the user provides a ranked score, the rules can be used to manipulate the score to select one or more montages for treatment.

[0073] 2 shows the neurostimulator 12 and other components of the system 10a to which it communicates. For example, the neurostimulator 12 can receive input from a user device 20 such as a smartphone 20a (or a tablet running Android or iOS, and an "app" 21 supporting all the functionality of the digital ecosystem), a smartwatch 20b, a laptop or tablet computer 20c (of the user or physician), a remote laptop or computer of a telemedicine service 20c', a specialized "remote control" 20d device (e.g., having only controls for therapy regimen parameter values ​​that are controlled and communicated to the stimulation device 12, or also having a display of therapy parameters), a virtual assistant AI technology (e.g., Alexa-type) device 20e, and a remote computer 20f that provides data storage and other functions. The remote computer 20f is understood to be a server computer that is connected to the Internet and may operate as part of at least one "server farm" or "data center" that enables remote support of the neurostimulator 12. The resources of the remote computer 20f are programmed to provide the functionality disclosed herein, including the provision of remote resources as is known in the art.

[0074] The device 12, user device 20, or other system components are configured to communicate bidirectionally with remote computer resources 20f at a center that provides automated or manual review of patient data, remote medical assistance for users, and other disclosed ecosystem functionality.

[0075] The neurostimulator 12 can be used alone or in combination with the user devices 20a-20f. In one embodiment, the control module 40 of the neurostimulator 12 can be configured in a "device only" or "standalone" default mode that is not switched to "user device" mode until the user device 20 establishes communication with the neurostimulator 12. This may occur upon first use, when the user must confirm with the user device 20a-20f that they wish to operate the neurostimulator in combination with one or more user devices 20 periodically during treatment, or may occur thereafter. In one embodiment, the user device 20 is a smartphone 20a running on the user device's operating system and operating under the control of a software application or "app" 21 that is uploaded to enable a wide range of functionality. The app 21 provides a user interface for controlling the neurostimulator 12, provides user alerts related to scheduled treatment sessions, presents surveys for the user or medical professional to complete to customize a therapy regimen, and provides multiple additional functions of the disclosed digital ecosystem. Alternatively, the user device 20 may be configured with limited functionality, such as displaying only a few virtual controls for switching between power on, power off, pausing / resume stimulation, and adjusting stimulation parameters such as intensity and predefined sets of active channels in the stimulation matrix. In one embodiment, where the user device 20 is implemented in a simple embodiment with few controls and functionality, additional functionality and features (e.g., questionnaire presentation and user input permissions) may be provided through a web portal or by the user completing a questionnaire and sending it by mail or email to a processing entity that enters / scans the information into the web portal's remote computer resource 20f. The web-based portal hosts a remote computer 20f to allow users to create an account to complete survey items and interact with a web interface for personalization and customization of a treatment program. Information entered into the portal can act on and then be communicated to the neurostimulator 12 or to one or more user devices 20 to customize a therapy regimen.

[0076] In an embodiment, user device 20 is realized as a user's smartphone 20a running app 21, which is configured to alert the user on the smartphone's speaker (auditory alert), vibration (vibrotactile alert) or display (visual alert) under control of a user interface module 48 function provided by the app 21. The visual alert may be a push notification presented by the app 21, or may be provided as a text message or email provided via the app 21 or scheduled to be sent from a remote computer 20f. The app 21 can also be designed to display a dashboard that allows a remote service physician to communicate using the remote computer 20c' to monitor / control a particular user's neurostimulator 12. When the portable computer 20c' is used as a dashboard, its control module 40 communicates with the control module 40 of the neurostimulator 12, and the dashboard is displayed and interacted with under the control of the user interface module 48. The portable computer 20c' is used by a physician to monitor and adjust stimulation parameters of a set of one or more remote patient neurostimulators 12, which may be in direct communication with the neurostimulators or may operate in conjunction with a server computer 20f that contains information about at least one set of neurostimulators 12. The user device 20 may also be implemented as a custom remote control device 20d with or without a display having customized function buttons for controlling stimulation intensity and adjusting active channel position and circuitry for providing alerts and user interaction. User devices can be realized as voice-based virtual assistant AI technology such as the Alexa Device 20e with software modules that can control the entire smart device ecosystem. TM ) Modules are Alexa "skills" (i.e., library-defined functions) that can be installed and enabled by the user and are programmed to provide functions such as: a) providing reminder alerts, b) allowing the user to start a therapy session, c) providing commands during a therapy session, such as commands to control the stimulation waveform (e.g., "Alexa, turn up the intensity", "Alexa, pause stimulation"), and d) providing commands to change the position of the stimulation field according to at least one defined series of pre-set stimulation montages (e.g., "Alexa, move stimulation left"). The remotely connected server computer 20f provides computer resources capable of communicating with a remote laptop 20c operated by a doctor, clinic, medical service or manufacturer, providing, for example, a) data storage of at least one set of one or more neurostimulator devices managed by the memory module 43, or b) a web portal accessed by a user via the Internet via a user interaction module, and c) virtual user control and communication with the neurostimulators 12 capable of displaying summary statistics of one or more sets of neurostimulators displayed on a dashboard. In an embodiment, the neurostimulator is configured to communicate with a remote computer 20f, either directly or via the user device 20a, according to start-up and stop routines of the control module 40 that occur at the beginning and end of each treatment session, or as an action when switching between a low power standby OFF state and an ON state (e.g., to upload log data or to obtain authorization to provide a treatment session).

[0077] Stimulus matrix. 3a shows an embodiment of a stimulation matrix 14 comprising six stimulation pads 16 on a flexible backing 51 realized using a non-conductive substrate. In an embodiment, the stimulation matrix 14 is realized using a reusable assembly of electrodes, each having a conductive hydrogel pad 16 for contacting the patient's skin and providing electrical stimulation. The stimulation pads 16 comprise a conductive material that provides a stimulation signal to the user's skin, and are also referred to as "electrodes" or "conductive pads." A view of the skin side of the matrix 14 is shown on the left side of the figure, with a first set of three pads on the top half (suitably positioned more proximally along the limb when the system is oriented correctly) and a second set of three pads on the bottom half (suitably positioned more distally along the limb). Each set of pads is arranged in a geometric configuration with a mathematical triangular envelope that defines a triangular configuration with two triangular apexes residing at the proximal and distal ends of the matrix 14, respectively. When secured to a user's leg below the knee, the upper half of matrix 14 is closer to the knee and the lower half is closer to the foot. When stimulation matrix 14 is secured to a user's limb, such as the user's arm, for treatment of arm pain or to modulate nerves in the arm (e.g., median nerve, ulnar nerve, radial nerve) for treatment of an unwanted medical symptom / condition, the upper half is closer to the shoulder and the lower half is more distally located, closer to the user's hand. The three stimulation pads 16 in the top half each have electrical conduits 54a, 54b, 54c that route stimulation signals to them from the hub 56, which continue through the backing 51 and connect to a stimulation matrix connector 62a on the top side of the matrix. Alternatively, signals can be routed to the pads individually without a hub, or a single hub can be used for all pads in the matrix 14. In the illustrated embodiment, the upper stimulation matrix connector 62a routes electrical charge and is a unique design that includes three male plugs that mate with a connector (not shown) with three female receptacles provided on the lower housing of the neurostimulator 12. Either portion of connector 62a or 62b may be magnetized to improve connection to the bottom housing of device 12. The connectors in the bottom half of the matrix (corresponding to those in the top half) are not labeled 54d, 54e, 54f to avoid cluttering the diagram, and are connected to bottom half stimulation connector 62b. Indication 64, which may include the word "top," is located opposite matrix connector 62b to provide a visual marking to guide the user in the correct connection / orientation of stimulation matrix 14 to device 12. In another embodiment, a marking 64, which may include the word "top," is placed on the opposite side of the matrix connector 62b to provide a visual marking to guide the user in the correct connection / orientation of the stimulation matrix 14 to the neurostimulator 12 (i.e., forming a "keyed" connector as shown in FIG. 1c).

[0078] In an embodiment, the matrix 14 employs stimulation pads 16 made using a conductive hydrogel or metal alloy. The pads can be used with a conductive gel or as "dry electrodes" for transcutaneous electrical stimulation. In one embodiment, the matrix is ​​formed of a conductive backing layer with the stimulation pads 16 present on the conductive backing layer that are configured to contact the skin and deliver electrical stimulation to the skin through the conductive backing. The skin contacting stimulation pad 16 can be made of a polymer, plastic or rubber material and typically has a conductive material that is uniformly distributed throughout and has a thickness between 1 mm and 10 mm, which can be filled with single wall carbon nanotubes or other conductive substrates.

[0079] In one embodiment, the stimulation matrix 14 is a hydrogel electrode array assembly that is applied to the skin on the medial surface of the leg over the SAFN and has six stimulation pads 16 of a size and shape suitable for delivery of stimulation signals, and is configured to fit the user's leg and to increase the likelihood of obtaining desirable characteristics of the vector stimulation field, such as physical dimensions: a) narrow enough and not wider than necessary to reduce the risk of undesired stimulation of the calf muscles or non-saphenous nerves, b) wide enough to provide sufficient range over which the position of the field can be controlled to successfully obtain nerve recruitment, and c) long enough so that the pads are far enough apart to form a field deep enough to stimulate the subcutaneous target nerve. The pads 16 are also of sufficient size to provide a comfortable and safe current density and to prevent the risk of unwanted skin nerve activation and pain / discomfort. The matrix 14 reduces electrode-to-skin impedance and is realized with each pad comprising silver electrodes on a flexible PET substrate typically covered with a layer of adhesive-containing tacky hydrogel to facilitate connection to the user's leg. In an embodiment, the matrix 14 is realized using stimulation pads 16 arranged in a defined geometric pattern, each of which can act as active, return, or ground and can be an independent current source allowing user control over the stimulation field geometry. In one embodiment, at least three pads are used, corresponding to at least three stimulation channels.

[0080] In an embodiment, the stimulation matrix 14 is reusable, allowing for a limited number of therapy sessions. Sessions can be tracked and limited to an authorized amount by the matrix management module 49 of one or more user devices 20 of the neurostimulator 12. A connector 62a on the top side of the matrix 14 engages with a connector portion 34a on the bottom of the stimulator housing and provides an electrical interface with the stimulation channels of the stimulation module 42. As shown in FIG. 3a, the connector 62a also includes an electronic ID chip 37 that the system 10a uses to a) verify that the matrix is ​​an authorized product of the company, b) track the number of times the matrix has been used, and c) obtain the manufacturing date to verify that the matrix is ​​not too old. The ID chip 37 may include a memory device, and the matrix management module 49 may read and / or write parameter values ​​related to the number of stimulation sessions (or days) the matrix has been used. The system may read and write valid or stale "flag" values ​​in the chip 37 or other memory structures of the system, depending on usage criteria. The matrix management module 49 of the device 12 is configured to read and evaluate the ID chip 37 and, if specified usage criteria are met (e.g., number of valid therapy sessions, maximum interval based on date of first use, etc.), disable the device or matrix 14 or present a message to the user or send (or prompt the user to allow a purchase request to be sent) to the remote computer 20f to have a new matrix purchased and shipped to the user. The usage criteria can be evaluated based on data stored on the ID chip, the neurostimulator, the user device, or the remote computer 20f.

[0081] In an embodiment, the flexibility of the matrix pad 14 is improved by providing gaps / slits 60b along the outer region of the backing 51, which allows the backing to bend and conform to the contours of the limb to which it is applied. The backing 51 has alignment slits 60a that are asymmetric or otherwise shaped or located along the perimeter to require precise alignment between the backing 51 and the device bottom housing 24b. Only one edge of the stimulation matrix or matrix 14 may have alignment slits 60a that engage with pegs on the device housing (not shown) to provide correct orientation of the stimulation matrix 14.

[0082] In one embodiment, the predetermined arrangement of stimulation pads 16 of stimulation matrix 14 includes defined angles and spacing between three or more stimulation pads that define three stimulation circuits. In one preferred embodiment, matrix 14 includes an upper set of three stimulation pads 16 in its upper half and a lower set of three pads in its lower half. The upper set of pads 16 have a lateral offset between the edges or centers of the pads (not necessarily in a triangular arrangement). The lower set of pads can have a similar arrangement, or the two sets of pads can have different inter-pad spacing.

[0083] In a further embodiment shown in Figure 3a, the top half of the stimulus matrix 14 is realized using at least two rows of pads 16, with the center pad being laterally offset (overlapping) such that there is a lateral overlap with the adjacent pads in the row below. This arrangement is referred to as an "overlapping triangle" configuration. The center pad in the first row is vertically offset with respect to the adjacent left and right pads that form the base of the triangle. The pad arrangement provides adjacent pads that are diagonally offset from one another to form a triangle (one pad at the apex and the other two pads forming the base) and provides the advantages of a) a stimulation matrix 14 with reduced width compared to the stimulation matrix 14 that would result if all three pads were aligned laterally and placed along the same row, and b) the combination of the lateral overlap of adjacent pads and the vertical offset covering a larger area than a single row provides an increased likelihood of neural recruitment compared to having three pads in the same row. The overlapping and narrowing design can be extended to rows using additional numbers of rows or pads (e.g., 3-5 pads). The stimulation matrix design can also incorporate rows with more than five pads, although this may increase the complexity of use and manufacturing costs of the matrix 14.

[0084] While many stimulation montages are possible using the six stimulation channels (any of which can be anodal or cathodal or inactive at any given moment), an advantageous strategy is to utilize a set of three stimulation circuits, each positioned vertically between the top and bottom of the stimulation matrix and including two leftmost pads, two middle pads, and two rightmost pads.

[0085] An extracorporeal stimulation matrix with fixed stimulation pad sites and electrical field steering has not, to the inventors' knowledge, been created previously. When field steering is accomplished in combination with the use of a stimulation matrix that includes a three-pad "triangle" configuration, several advantages are realized. First, the size of the matrix pads can be reduced to that achieved with equally spaced rows of pads because the top pads at the apex of the triangle and the bottom pads at the base row of the triangle are offset so that pads in adjacent rows overlap horizontally. Second, the triangular configuration allows adjustment of the position of the stimulation field along both the horizontal and vertical axes of the matrix. For example, the stimulus montage shown in Figure 6b generates a longer vertical field than in Figure 6h (white - "active" / grey - "inactive"). Moreover, in relation to Figure 6h, Figures 6i and 6j generate fields that extend vertically downwards and upwards, respectively. Using only six pads, configured in two sets of three, each with a triangular geometry, left-right and up-down spatial adjustment of the stimulus field is possible. Diagonal circuits offer an additional field geometry to those achieved with strictly longitudinal activation patterns. The diagonal stimulation field travels up the leg along the axis, potentially increasing the likelihood of entraining nerves that are not directly beneath the activated stimulation pad. Examples of diagonal stimulation circuits are shown in Figures 6d and 6e.

[0086] The combination of a) the placement of two sets of stimulation pads in the stimulation matrix, each set with a fixed triangular geometry, b) the use of field steering, and c) proper anatomical placement of the stimulation matrix according to detailed instructions provided to the user with both video and text support, provides the stimulation matrix with the following advantages: i) a reduced footprint compared to non-overlapping pads, ii) the provision of adjacent stimulation circuits with increased likelihood of vector overlap due to adjacent stimulation fields, and iii) improved ability of the stimulation matrix to be used on subjects with a wider range of leg circumferences (and lengths) while improving the likelihood of reliably delivering treatment to the target nerve.

[0087] The stable geometry of the stimulation pads of the stimulation matrix can provide improved control of vector stimulation over that achieved with a set of conventional stimulation pads connected by wires and manually positioned by the user. The fixed matrix can provide better targeting of pulsating or other vector fields at the target nerves due to the stable and repeatable geometry of the stimuli applied to the skin surface.

[0088] The inventors have also evaluated a linear arrangement of non-overlapping pads, where the center pad is not offset and three pads form a single row. Without wishing to be bound by theory, it appears that the triangular overlapping arrangement has the following advantages: a) Preferred by subjects. b) It reduces the risk of a nerve lying between the stimulation fields created by pads placed with a "lateral" gap between the pads. c) Increases the longitudinal extent of the stimulation field compared to using a row of pads that may underlie part of the target nerve, increasing the likelihood that the field will intersect branches of the target nerve. d) Narrow the width of the matrix. A wider matrix 14 would extend further into the leg circumference and be disadvantageous because: a) it would increase the risk of muscle recruitment, b) it could limit the tolerable amplitude or target other nerves in the leg in addition to the SAFN which could cause motor activity in the leg, and c) it would provide a poorer fit for individuals with thin / small legs. When one upper and one lower row was tested in a group of subjects, disadvantages were observed, including fewer reports of robust neural recruitment and increased reports of self-reported calf muscle activation, discomfort, and cramping. Other arrangements, such as one or two rows of linearly arranged pads on each of the upper and lower matrix portions, may offer certain advantages for field steering or shape generation (e.g., an arrangement of many smaller sized pads to provide finer control of the stimulation field). However, when using sets of three stimulation pads 14 on the top and bottom, the overlapping design appears to hold advantages.

[0089] In one embodiment of the matrix 14 shown in Figure 3a, the top set of pads is implemented using three pads each having a conductive surface of approximately 1.0 to 1.5 square inches and are implemented as a rounded rectangular, square, or slightly circular outline. In one embodiment, the matrix pads 14 are implemented as a disposable component of the system. The flexible backing is made of a polyethylene terephthalate (PET) or polyimide substrate, printed silver, and a dielectric insulator, and the pad is made of a scrim assembly that can be constructed as foam, non-conductive and / or conductive hydrogel, hydrogel, and hydrogel-forming dots or pads configured on a scrim of finely woven non-conductive mesh of polyester, nylon, polyamide, or similar material.

[0090] In one embodiment, the matrix 14 is realized as upper and lower halves that are separately formed and connect independently to the neurostimulator 12, allowing each half to be replaced independently, reducing the cost of replacing the entire matrix 14.

[0091] Without being bound by theory, a stimulation matrix may have many more stimulation pads (e.g., 10, 50, or 100), but a peripheral stimulation wearable device configured for the arm or leg will achieve many of the advantages and therapeutic effects disclosed herein while preferably using a first stimulation array of no more than three pads and a second stimulation array of no more than three pads. For stimulation of the SAFN, this suggests that a stimulation matrix design that is cost effective and not overly complex to use is preferably achieved using pads of 6 (i.e., 2 sets of 3), 7 (see FIG. 7c) or 8 (see FIG. 7b) and no more than 18 (i.e., 2 sets of 9) stimulation pads. The cost and complexity of using more pad sets in a stimulation matrix design can be beneficial when sensing or other functionality is incorporated.

[0092] Figures 4a-4d show four patterns of stimulation pads 14a-14d that were evaluated in a group of subjects. Part of the evaluation involved determining whether the movement of field location from the left to the right side of the pad exceeded the subjects' just noticeable difference (JND) threshold for detecting the change. Another part of the evaluation included asking about the perceived pleasantness of the stimulation and the subjects' ability to detect SAFN recruitment. The first pattern shown in Figure 4a was rated as preferred because it allowed subjects to more easily sense the movement of the stimulation field's position relative to the three different zones (left, center, and right) and provided a clearer confirmation of neural recruitment. Figure 4b shows another embodiment in which the top and bottom halves of the stimulation matrix 14b have different numbers of stimulation pads (i.e., only one stimulation pad in the bottom half and three pads in the top half). Stimulation with this configuration could be achieved with the bottom pad acting as one anode channel completing a circuit with one or more of the three cathodes, or vice versa. This more minimal design also allowed for field steering, but had the drawback that field motion was not apparent in some subjects and did not reliably recruit SAFNs according to subjective report. Furthermore, when a single pad was used as the anode, it produced an anode-dominated stimulus, which suffered from the drawback that the stimulus was mostly felt below that pad, presumably due to the large current density at the anode. Thus, in this matrix design, it may be necessary to increase the size of the anode surface area (e.g., by a factor of three) to prevent "anode domination" (i.e., subjective sensation is dominated by sensations near the anode), resulting in coarser field steering than that obtained using the design of Figure 4a.

[0093] Figure 4c shows an embodiment in which the stimulation pads of the stimulation matrix 14c are larger and closer together than in Figure 4b. This design reduced the spacing between the electrodes and also appeared to have the disadvantage of reducing the user's ability to perceive changes in the position of the stimulation field when the bottom electrode was paired with any of the top three stimulation pads. Compared to Figures 4a and 4b, there is more overlap between the fields generated between the circuits involving the bottom pads and any of the three pads at the top of the matrix. Finally, circular pads were also evaluated using the design shown in Figure 4d, as they may allow for the design of a more compact stimulus matrix 14d. This did not appear to offer any improvement in subjects' ability to see the movement of the electrical stimulation field (assessed by verbal report) compared to a geometric arrangement consisting of rounded and square pads (Figure 4c). An advantage of the present invention is that it uses stimulus parameters and matrix characteristics (such as the lateral offset of adjacent pads, the space between pads, etc.) that allow the majority of users to perceive a change in the position of the stimulus field when adjacent circuits are selected. Pads located in adjacent rows should overlap by less than 50% to allow users to distinguish horizontal movement of the field.

[0094] Stimulus matrix design may be influenced by several potential tradeoffs between increasing the compactness (e.g., overlapping pads) or complexity (e.g., using many pads) of the arrangement of pads on the matrix and at least a) the ability of the user to distinguish between different field steering configurations and b) increasing the “confidence” for successful or strong recruitment of SAFNs. A design that is too compact may also increase the risk of electrical shorts between adjacent pads due to the small edge-to-edge distance between them. Without being bound by theory, to avoid shorts, the minimum edge-to-edge distance should range from 0.1 to 1.0 inches, preferably about 0.1 to 0.3 inches, but typically should not be less than about 0.1 inches. When applied to the lower extremities, the stimulation matrix pad is approximately 3 inches wide and approximately 6 inches tall (crown-caudal axis). In one embodiment, to accommodate the majority of the population, three different sizes of matrix pads are used that are 75% and 125% of the height and / or width dimensions shown for the pad in FIG. 4e. The stimulation matrix 14 may be provided as a single piece or as two halves that are independently secured to the bottom of the housing of the neurostimulator 12.

[0095] While the examples shown in Figures 4a-4e used four or more stimulation pads, in embodiments, field steering can be achieved using a set of only three stimulation pads. This design could be used with the features of the present invention, but has not been tested. However, it appears to be less favored by subjects, for reasons already discussed. A minimum set of pads allowing field steering may include, for example, three stimulation pads realized as two cathodes displaced laterally relative to the limb axis and placed close to one anode. In this example, field steering can occur by selectively and partially activating a combination of three pads, with the amplitude of the signal between Cathode 1 and Anode 1 set to 90% (90mA) of the 100mA signal, and the signal between Cathode 1 and Anode 2 set to 10% (10mA). If the two pads reference a common stimulus return pad, the two stimulus source pads can each be driven by the output of a stimulus generator while the common stimulus pad is connected to the return side of both stimulus generators, with the tissue between each channel acting as two loads in the electrical circuit. In one embodiment, weights defined by a lookup table are used to assign a higher weight value to the first cathode or the second cathode to determine whether the stimulation field is on the right or left side of the stimulation matrix.

[0096] Neurostimulation Protocols and Programs FIG. 3a shows a stimulation matrix 14 having six stimulation pads that can be assigned to function as cathodes, anodes, or inactive channels. If one limits the stimulation provided to the top three pads, the number of possible permutations of different channel combinations can be managed (e.g., left pad is anode, right pad is cathode; left = anode, center = cathode; left = anode, center and right pads = cathode) and may be less than 20. However, if different channels can use different amplitude weighting values ​​(e.g., left pad = 100 mA (anode), center pad = 70 mA (cathode), right pad = 30 mA (cathode)), the number of possible combinations becomes very large, even when limited to a few different sets of weights. Furthermore, when the bottom three sets of pads are added to the permitted stimulation protocol, the number of combinations becomes unmanageable. Adjusting the stimulation parameters by the patient (or physician) may be too complicated and time-consuming to be practical. Providing unconstrained freedom in adjusting the stimulation protocol creates many problems.

[0097] The SaphLocate feature of the present invention allows a user to evaluate different candidate stimulus montages in a simple, user-friendly, and time-efficient manner using a limited number of selected stimulus montages that are adjusted or selected by the control and method.

[0098] SaphLocate allows the user to easily and intuitively adjust the location and shape of the stimulation field and evaluate a limited number of combinations of active channels. In an embodiment, one SaphLocate program only allows the adjustment of the location of the stimulation field along the lateral axis of the stimulation pad. SaphLocate can also provide the user with a limited number of montage candidates associated with the adjustment of the stimulation depth.

[0099] In an embodiment, the SaphLocate function also provides adjustments to the stimulus field according to settings designed to ensure that the user's adjustments to the field position meet sensory criteria such as a) being perceived by the user, or b) not having large perceptual jumps in intensity. For example, the montages associated with providing the various field positions are set to be greater than marginal differences for at least 50% of the subjects' groups.

[0100] The SaphLocate feature allows the user to compare candidate stimulation montages and select a preferred montage for treatment. The preferred montage may provide at least one advantage, such as improved neural recruitment, improved comfort, or reduced risk of unwanted stimulation of non-target tissues, such as muscle. SaphLocate improves the selection of the stimulation protocol to be used during treatment. When used for non-SAFN targets, this may be referred to as "NiNALocate."

[0101] The NiNA System also offers a SaphLevel feature that allows advantages to the user when adjusting and selecting the amplitude levels and waveforms used during stimulation therapy. The SaphLevel feature provides the user with benefits such as a better sensory experience of stimulation, improved neural recruitment, and allowing the user to tolerate higher intensity stimulation.

[0102] Thus, the SaphLocate and SaphLevel functions have the advantages, for example, of: a) a limited set of stimulus montages; b) stimulus montages that provide the user with an improved sensory experience; c) stimulus montages that improve neural targeting; d) a predefined series of stimulus montages that define how subsequent montages follow the current stimulus montage; e) a defined series of montages with weighting values ​​set to enable smooth perceptual transitions of stimulus field characteristics such as shape and position.

[0103] The SaphLevel of this invention TM The feature offers advantages with regard to adjusting the intensity level of stimulation and the corresponding subjective experience, as well as the ability to modulate the target nerve. TM The SaphLevel and SaphLocate functions provide advantages with respect to adjusting the position or geometry of the stimulation field. The SaphLevel and SaphLocate functions may use similar weighting values ​​and strategies, but are used to achieve different advantages.

[0104] Both the SaphLocate and SaphLevel functions of the present system may rely, at least in part, on techniques that enable the field geometry, location, and intensity settings to provide improved treatment or an improved patient experience in connection with: a) to provide limited and targeted adjustments to the location and geometry of the stimulation field during initial evaluation and selection of candidate stimulation fields for later use during treatment delivery, b) to allow the user to easily evaluate different stimulation fields during this initial adjustment, and c) to provide advantages to the stimulation fields used during the treatment session related to improved comfort and neural recruitment.

[0105] In one embodiment, the limited set of stimulus montages involves defining a set of three pairs of active channels defined as left, center, and right, and assigning weights to each of the three circuits that allow the stimulus field to transition from the left to the right regions of the stimulus matrix in a manner that is distinguishable and smooth with respect to the perceived intensity of the stimulus field.

[0106] When stimulation is greatest in the center pair of channels, these are considered to define the "primary channels" and the left and right channels are non-primary. Generally, the primary channels are the channels with the greatest amplitude (i.e., greatest weighting) and the "non-primary" circuits or channels are assigned lower weighting or are inactive. One of the SaphLevel features is to provide lower weighting on non-primary channels to produce at least one advantage over what would occur if the non-primary channels were simply deactivated.

[0107] In an embodiment, the SaphLocate control only allows for adjustment of the position of the stimulation field along the left / right axis of the matrix. In one embodiment, adjustment along the left / right axis is provided using a limited set of stimulation montages that have been shown in a group of subjects to enable recruitment of target nerves such as the SAFN, or have been shown to enable smooth and discernible transitions between montages. The series of montages may also include a predefined set of allowed transitions between adjacent stimulus montages (i.e., the user cannot "skip" a predefined set of stimulus montages and corresponding channel weighting values, as defined in a series of at least three adjacent montages defined in a lookup table). In another embodiment, two "diagonal" montages are also provided in the limited set of stimulation montages that use two stimulation channels selected from different columns of the matrix. In one embodiment, SaphLocate does not include montages with stimulation circuits that are nearly lateral fields separated by less than a selected distance, because these would have corresponding shallower-than-normal field paths.

[0108] In an embodiment, the stimulation signal is adjusted using the system's SaphLocate function, which improves the user's ability to compare and select stimulation protocol settings related to the geometry of the stimulation field provided by the matrix 14 through the user's skin. The SaphLocate function includes: a) adjusting the shape of the stimulation field by changing the geometry of the active stimulation channels provided by the arrangement of a limited number of stimulation pads during treatment, b) steering the stimulation field by changing the geometry and / or amplitude and / or designated (anode / cathode / inactive) status of a predefined set of stimulation pad montages, and c) providing "weighted" stimulation intensity settings for each geometry of the set of stimulation geometries, so that transitions between various combinations of active stimulation pads, and the corresponding movements of the stimulation field, occur smoothly without undesirable jumps in actual or perceived intensity.

[0109] In embodiments, the treatment uses stimulation settings with various SaphLevel features that provide advantages in determining settings related to stimulation intensity and neural recruitment. a) guiding the user to select a stimulation intensity level that sufficiently recruits the target nerves but below a level that is painful to the user; b) notifying the user to readjust the intensity midway through a treatment session to compensate for possible adaptations that could allow the stimulation to be set higher; c) providing stimulation intensity settings that are "weighted" relative to the selected matrix geometry such that the sensory experience of the stimulation is "richer" and potentially less painful (as may be predicted by gate control theory); and d) additional features as disclosed. A "richer" perception of stimulation was provided without activating the non-primary channels, described by users as less sharp, "tingly" and point-specific than occurs with dual-channel stimulation, with a rounder sensation of pressure from the stimulation that was perceived as less "sticking." The SaphLevel feature may also include guiding or probing the user to ensure that the appropriate stimulation intensity and stimulation channel are being used. For example, the user may be asked questions to ensure that the stimulation intensity is sufficient to modulate the target nerve, reduce unwanted muscle stimulation, or improve the perception of the stimulation.

[0110] Facilitating outpatient care with SaphLocate / SaphLevel. The SAFN is a sensory nerve, and targeted stimulation will evoke a sensory response without a motor response, a hallmark of PTN stimulation etc. If SAFN stimulation selectively modulates the SAFN with little or no concomitant activation of the calf muscles or nearby motor nerve recruitment, the user should be able to walk during stimulation treatment. This may be the case even if the stimulation protocol produces moderate or strong paresthesia. Given the low risk of unintended motor / muscular responses, this also reduces the associated risks of muscle tearing, unwanted leg movements (i.e., contractions), uncomfortable muscle twitching, gait disturbances, etc. Similarly, the risk of losing control when using one's foot to operate the gas or brake pedal of a car is reduced. Thus, in targeted SAFNs, where the field is constrained (e.g., by field steering or selecting an appropriate stimulation montage) to avoid / minimize coactivation of undesirable tissues or neural targets, the user can still engage in activities while stimulation therapy is being delivered. SaphLocate and SaphLevel help reduce the risk of unwanted muscle stimulation by allowing better selection of stimulation parameters, thus enhancing the ability to deliver therapy while the user is walking.

[0111] Additionally, evaluation of sensory data (e.g., accelerometer or EMG data) can be used by the SaphLevel algorithm to adjust stimulation parameters (e.g., decrease stimulation amplitude) if these data indicate that the user is engaged in activity above a selected threshold. For example, slow walking may be permitted, but walking above a selected speed may cause stimulation to stop, decrease stimulation amplitude, or pause for a defined interval, until accelerometer data again indicates that the user has become less active. Improved targeting of the SAFN, allowing stimulation of the SAFN with less unwanted coactivation of other nerves or muscles in the leg, can be achieved by at least one of: a) field steering, b) selecting a position that does not stimulate another nerve in the leg, c) selecting a position on the leg that does not stimulate the calf muscles, d) using two or more stimulation pads of a matrix placed on the medial aspect of the leg in a position that stimulates the SAFN but does not directly stimulate either the sural nerve, posterior tibial nerve, tibial nerve, peroneal nerve, or plantar nerve, and e) providing stimulation using two or more stimulation pads that create a current pathway along the axis of the limb (i.e., offset longitudinally so that one pad is more proximal and the second pad is more distal), with the stimulation protocol tailored to provide targeted stimulation of the SAFN.

[0112] 3b shows a touch-sensitive graphical user interface (GUI) display 70 of the user device 20a with a default treatment session screen displayed during treatment. In the illustrated embodiment, a timer 72 indicates the time remaining in the treatment session using both a numerical and graphical representation of the percentage of the total 30 minutes of treatment session time that has elapsed. Although a 30 minute treatment session is shown, the duration of the session may be, for example, between 15 minutes and 90 minutes. In an embodiment, multiple sessions (e.g., 1 to 3) can be scheduled once per day.

[0113] The virtual controls allow user control of stimulation signal characteristics, including a "Stop" control 74 that pauses stimulation therapy (e.g., the intensity is set to zero and the timer stops incrementing), and two intensity controls 76a, 76b that include a plus sign "+" and a minus sign that increase and decrease the stimulation intensity, respectively. The field steering manager interface 78 also provides a SaphLocate function, such as left and right controls 80a, 80b, which move the stimulus field from the left to the right side of the matrix using a series of predefined stimulus montages. Using appropriate amplitude weighting in the stimulus montage allows smooth adjustments in the field geometry or position, so that the user perceives movement in the field position. Five circular field position indicators 82 are highlighted as the field moves from left to right, which when worn on the upper calf can cause the field to move from the front near the tibia to the back of the leg, or vice versa, depending on which leg the matrix is ​​worn on. In an embodiment, the SaphLocate function provides a field location indication 82 on the display screen of the neurostimulator 12 and / or user device 20a to enhance the user's perception of the adjustment of the stimulation field.

[0114] In embodiments as disclosed, the field steering manager interface 78 can be expanded to include additional "advanced" controls for selecting (i.e., double tapping) to adjust characteristics of the stimulation field such as the horizontal or vertical center of the field, adjusting the number of montages used to move the field from a first position to a second position (e.g., left to right), or allowing the user to adjust whether a set of one or more stimulation pads functions as an anode, cathode, or is inactive. As disclosed, control of individual channels may typically be too complicated for most users. However, in some cases, turning off a single stimulation channel may be useful, such as deactivating the lower right or lower left stimulation pad to attenuate unwanted calf muscle activation. When a stimulation channel is deactivated, the SaphLocate algorithm can adjust the remaining active channels so that the anodic / cathodic charge delivered by the matrix is ​​balanced.

[0115] In the illustrated embodiment, SaphLocate is implemented with a left-right control that allows selection of a stimulus montage from a set of five separate field montages defined along the left-right axis of the stimulus matrix. Each of the five defined "zones" has an associated location label, such as left, center left, center, center right, right, etc. Also, a "global" setting provides the stimulus field at approximately the same amplitude in all zones. In this example, the matrix of Figure 3a will be used, although other arrangements of stimulation pads could be used instead. If the stimulation pads of matrix 14 are conceptually arranged as rows and columns, there are three columns of electrodes, and the on (1) / off (0) states of each column created for these five stimulation montages and the "ALL" montage can be defined in a simple embodiment as 0100, 0110, 0010, 0011, 0001, and 0111, respectively. In Figure 3b, the user has selected a center-right zone which causes the stimulation signal to be provided by the two pads in the center (vertices) and the two pads on the right side of the triangular arrangement of the stimulation matrix shown in Figure 3a. As will be considered, instead of three columns with two vertically offset channels each, the stimulation pattern can be defined for a pair of diagonally offset channels (i.e., a circuit is created from channels selected from different columns).

[0116] Thus, the field steering manager interface 78 provides for user independent adjustment of both the strength 76a, 76b and position 80a, 80b of the stimulation field generated by the sum of the stimulation signals provided by the stimulation matrix 14. In the illustrated embodiment, the position of the field is adjusted along the left-right axis of the matrix 14 (i.e., perpendicular to the axis of the stimulated limb) using only two controls. Alternatively, the field position indications of illuminated circles corresponding to the left and right locations of the field can also be selectively activated by the user sliding a finger across the circle or double-tapping the circle to adjust the stimulation field to the field setting associated with the respective circle.

[0117] In an embodiment, instead of five zones and an "overall" setting, the user device 20 may be designed to provide the user with coarser stimulation field control (e.g., only three zones can be selected and only the left, center, or right columns of stimulation can be active). Alternatively, finer resolution (e.g., 7-10 or up to about 15-20 zones) of adjustment is defined using separate steps with weight values ​​for each column defined in a lookup table. Instead of the simple on (1) / off (0) status used in the example above, if more stimulation zones are provided than there are stimulation columns available in the stimulation matrix, the columns are assigned weight values ​​that represent a "percentage of total stimulation amplitude" (e.g., current) resulting from a weighting operation. Weighting values ​​are used to adjust the amplitude of each column: for example, a "left" setting can be realized as 10000, "center" can be realized as 1000, and a gradual shift from left to center can be achieved using a series of montages with corresponding weights (e.g. 90100, 80200, etc.).

[0118] In an embodiment, the user can switch between "coarse" field control (e.g., 5 zones) and "fine" field control (e.g., 15-20 zones) as a matter of user preference. Alternatively, the user can select the number of zones from a permitted range (e.g., 3-20). Using more zones (e.g., 15) instead of fewer zones (e.g., 5) results in a more gradual change in weighting values ​​as the stimulus field moves from left to center to right of the stimulus matrix. For example, using seven zones, as the field moves from left to center, the circuit weightings may change by 15% between each adjacent zone, with the left channel weightings transitioning as 100, 85, 65, 50, 35, 20, and 5, and the center channel weightings increasing inversely as 5, 20, 35, 50, 65, 85, and 100. However, while the transition may be smoother, increasing the number of zones requires the user to spend more time trying to discern the differences between the montages. Without wishing to be bound by theory, during pilot work, some users preferred finer field steering control, but this appeared to frustrate or confuse users who had difficulty distinguishing between the zones and did not seem to benefit from the finer control. The number of zones and the differences between them should be sufficient (i.e., greater than or equal to the JND) so that the majority of users, or the user operating the neurostimulator, can sense the movement of the field position, but not tedious with the number of adjustments.

[0119] In an embodiment, rather than using zero for any weights, the SaphLevel rule implemented by system 10a requires that the weights are always set above a level such as 30%. Setting the weights of the non-primary channels to non-zero values ​​has the following advantages during therapeutic stimulation: a) providing stimulation to the non-primary channels may make the stimulation feel richer, b) providing stimulation to the non-primary channels may improve recruitment of the nerve due to increased vector field energy at the target nerve, c) supra- or sub-threshold stimulation at the region of the nerve provided by stimulation of the non-primary channels may increase the likelihood that stimulation from the primary channels will result in neuromodulation, d) lower amplitude of the primary channel may be required to recruit the nerve when energy from the non-primary channels is also provided, which may improve patient comfort, and e) higher amplitude may be used in the primary channels due to factors such as sensory masking. The weights used in the non-primary channels may also vary as a function of the amplitude provided in the primary channel, for example, there may be greater attenuation of the weights when the amplitude of the primary channel stimulation signal is well above the neural recruitment threshold. With regard to SaphLocate, the use of non-zero channel weights also helps when the position of the stimulation signal is adjusted, for example, from the left to the center-left channel. For example, increasing the center-left channel weight from 0% to 50% will be larger than increasing the value from 40% to 60%, making the transition feel smoother. Also, setting the weight to 40% instead of 0 makes it more likely that the stimulation is already above threshold, so an increase to 60% will result in a smaller change in neural activity and perceived intensity than going from 0% to 50%.

[0120] Adjusting SaphLocate parameters individually In an embodiment, the number of zones (and associated number of stimulus montages and corresponding weighting values) are selected based on the results of an evaluation procedure that occurs during user onboarding. For example, an assessment of a user's sensitivity to finer changes could be assessed by asking the user to press a button if they perceived a change in the stimulus field position as the position alternated between two settings, as might occur in a forced-choice threshold test where the threshold defines the difference between the two settings. For example, the system could automatically move the field using a coarse setting, then increase the number of zones and determine if they are sensitive enough to detect movement between zones confirmed by the user pressing a button. Once the user's JND for distinguishing locations has been established, this can be used to set the SaphLocate zone parameters.

[0121] In an embodiment, the SaphLocate function adjusts the stimulation protocol so that both a) the number of montages presented to the user, and b) the corresponding weighting values ​​are selected such that the user typically a) perceives field movement when selecting different montages, and b) the field movement does not occur with a large change in the perceived intensity of the stimulation.

[0122] An advantage of the present invention is that it provides adjustable levels of stimulation field control, including at least two user selectable levels of specificity or coarseness.

[0123] In one embodiment, the coarseness of the zones can be set by selecting the "Settings Gear" control (see menu control in FIG. 9a). This presents the user with options related to therapy, such as control of stimulation adjustments using "fine" or "coarse" stimulation resolution. When clicked, the pressed "Position Resolution" option displays "coarse" and "fine" device control options (see FIG. 3e).

[0124] Figure 3c shows the treatment screen 208 where the number of zones has been set to 15 using the fine resolution method. This can be achieved using 15 different weighting functions for the three (or more) channel pairs stored in a lookup table. In this example, when the field steering protocol is set to "global", this involves three separate columns of constant current stimulation with all channels in the matrix having equal weighting. The “whole” setting is an important option because during studies in which the stimulation montage was limited to three longitudinal circuits (each containing a pair of pads with a single anode and cathode), some users preferred stimulation using “whole” (more than any of the 15 montages that moved the field from left to right in the matrix) because this provided better neural recruitment than using a montage with lower weightings on some channels, as evidenced by the strong stimulation-induced paresthesia reported in the lower limbs or feet with little or no muscle stimulation.

[0125] 3d shows the treatment screen 210 with the field steering protocol set to center, again with 15 zones. In one embodiment, "center" can be such that the two pads in the center column of the stimulation matrix have a weighting value of 100%, while the adjacent pads in the left and right columns are weighted as zero (i.e., set as inactive).

[0126] 3e shows a position resolution screen 212 displayed by device 20, with a menu for the user to select coarse (e.g., 5-7 zones) or fine (>7) resolution. When used by a medical professional, the resolution screen may allow for more detailed control in connection with defining stimulation zones along at least one axis of the stimulation matrix, such as allowing the user to select any number of zones from 5-20 zones (and associated weightings). Also, if the stimulation field is adjustable along multiple axes, the resolution can be set differently for the x-axis (vertical) and y-axis (horizontal) of the stimulation field. A coarseness can also be defined for such adjustments if the user uses a graphical display or joystick to move the stimulation field along the x-axis or the y-axis, or both simultaneously.

[0127] In an embodiment, a "coarse" controller scheme utilizes between 3 to 9 steps between the leftmost and rightmost field settings, with a preferred embodiment being approximately 5 steps, and a "fine" controller scheme utilizes 10 to 20 steps between the leftmost and rightmost stimulus field montages, with a preferred embodiment being approximately 15. These can be set separately for each axis.

[0128] 3f shows another embodiment of screen 214 when more than two columns of electrodes are provided in the stimulation matrix. In this example, the user can select a "narrow" or "wide" spread for stimulation, thereby activating, for example, stimulation pads in a nine-column matrix of, say, two or three columns (e.g., [0009010090000]), or seven or nine columns (e.g., [008090100908000]). In this embodiment, the weighting coefficients of the narrow or wide set for a set of pads move from left to right. In this figure, the weighting is displayed graphically so that weightings of higher amplitude are indicated by darker circles and become lighter shading as the weighting decreases. Adjacent pads can be weighted using a non-zero level (e.g., columns directly adjacent to the primary set of channels set to 50%) or a diffusion level known to provide a benefit to the sensation experienced by the user.

[0129] Additional Stimulus Signal Characteristics Without being bound by theory, in one embodiment, three aspects may serve as the primary determinants of the stimulation protocol selected for the treatment of a target nerve such as the SAFN. It should: A) provide neuromodulation but at a low enough intensity level that it is comfortable / tolerable to the user during treatment; B) be provided by a matrix of stimulation pads and stimulation montages configured to steer / shape the stimulation field so that it is focused on / near the target nerve to improve neurotargeting; and C) have pulse characteristics that provide powerful neuromodulation.

[0130] In addition to the SaphLevel and SaphLocate aspects of the stimulation protocol, the stimulation signal itself can be programmatically altered to improve neural recruitment. For example, pulse duration may be adjusted to improve target neural entrainment. A pulse width of 200uSec is often used for modulation rates in the 20Hz range for saphenous (or other) nerve stimulation, but increasing the pulse width to 400uSec-20,000uSec or using a duty cycle up to about 50% may result in deeper stimulation paths and greater entrainment. Longer pulse widths are also better for recruiting smaller diameter fibers, including unmyelinated C-fibers. Thus, controls for adjusting the pulse width can be displayed on the control screen, or montages associated with deeper stimulation paths can be combined with longer pulse widths as a SaphLevel feature.

[0131] User adjustment of stimulus field position and geometry. In embodiments, the SaphLocate function allows for evaluation and comparison of different stimulation montage settings to select one or more montages that provide improved neural recruitment for use by the treatment protocol. In the case of SAFN mobilization, a protocol that provides improved nerve recruitment can be defined, for example, as one in which any of the following occurs: the strongest perception of nerve recruitment is obtained; the evoked paresthesia changes from a mild tingling to a stronger sensation (e.g., a vibrating or throbbing sensation); the evoked paresthesia is felt at the most distal location (i.e., more distal to the foot and toes than eliciting sensation only near the stimulation pad); strong nerve stimulation occurs in the absence of unwanted collateral stimulation such as adjacent muscles or other nerves; strong nerve stimulation occurs in the absence of foot movement; the difference in stimulation energy required to elicit cutaneous sensation (cutaneous sensation threshold) and nerve recruitment (nerve recruitment threshold) is minimal; or the greatest amount of nerve recruitment reported by the individual in the absence of pain or discomfort. Any of these criteria can be used, but in many cases the patient will simply be asked to select a stimulation montage that produces a clear sensation of paresthesia that extends as far as possible toward the ankle and / or foot, while minimizing the effects of stimulating non-target tissues. Figures 5a-5i show embodiments of screens provided by user interface module 48 that allow adjustment of the stimulation field provided by stimulation matrix 14 operating in conjunction with the stimulation module.

[0132] 5a shows an embodiment of a "slider" field steering management console 216 in which the slider control is adjusted ("slid") from far left to far right. The user slides the bar control by swiping a finger across the touch display of the user device 20. The position of the bar is then set to the site most preferred by the user during treatment (e.g., the site caused by neural recruitment). The movement of the virtual control on the display screen of the user device 20 is accompanied by a visual signaling of the change in the position of the stimulation field. For example, one or more subsets of the set of colored circles may indicate the selected activation region in relation to the full range of the left-right axis of the matrix. Additionally, the "cl", "c2", "c3" labels at the bottom of the screen may display the percentage of amplitude applied to each of the three columns of the stimulation matrix (e.g., as shown in Figures 6a, 6b and 6c). The bar control may also be realized as a physical control on the housing of the device 12 or the user device 20, such as a remote control device.

[0133] In one embodiment, as the control slides from a left point to a right point, it passes through a series of intermediate points, and each point is mapped to a stimulus montage within the set of stimulus montages such that the movement of the control corresponds to sequentially selecting a series of stimulus montages, the set of stimulus montages being configured to change the position and / or shape of the stimulus field in an intended manner. For example, sliding a control can be mapped to move the stimulation field along at least one axis of the stimulation matrix, such as from left to right, thereby producing movement of the field without causing temporary jumps in the perceived intensity of the stimulation field.

[0134] 5b shows a "directional" field steering management console 218 with a set of controls realized as left and right arrows that the user manipulates to directionally adjust the left and right displacement of the stimulation field. This control has several advantages: It is easier for users who lack fine motor control, as they might need to adjust slider controls. The user presses the left or right control to gradually shift the location of the stimulation field to the left or right. It was found by the inventors that subjects tended to prefer a set of about five stimulation montages when spanning from left to right in the stimulation matrix designs tested. Increasing the number of settings took longer for subjects to evaluate, did not provide a consistent perceptible change in field location for the user, and made it difficult to select a preferred stimulation montage. In one embodiment for stimulating the SAFN, the directional control may use preferably five to ten montages, more preferably five montages. An "entire" montage may also be provided.

[0135] In one embodiment, at least one directional control is provided, which when pressed results in a defined movement of the stimulation field, such as from a left point to a right point. Typically, two directional controls are provided to allow user control in a first direction or in a second direction opposite to the first direction. Pressing the directional control incrementally selects a stimulation montage from a sequence of stimulation montages, whereby operation of the control unit corresponds to sequential selection of a montage from a set of stimulation montages (with montage characteristics, such as amplitude weighting values, defined in a look-up table or realized by adjustment of the electronics settings). The set of stimulus montages is configured to change the position and / or shape of the stimulus field in an intended manner in response to user input to the control, e.g., pressing a left or right directional control moves the stimulus field in a first or second direction along at least one axis of the stimulus matrix, such as from left to right.

[0136] 5c illustrates another SaphLocate function 220 of the system. In one embodiment of the "Cycle" field steering management screen, pressing the "P" button causes the stimulation module 42 to sequentially adjust the stimulation field stepwise through a set of stimulation montages that transition in a determined manner. For example, the transition is from a left-most position to a right-most position with respect to the stimulation matrix. The set of stimulation montages may include only vertical circuits (i.e., columns of the stimulation matrix) or may include one or two diagonal circuits. If a site is preferred, the user may confirm this, such as by pressing an input button labeled "P," or the user may provide a verbal instruction to "use that setting" if the user interaction module 48 is configured to receive voice commands. The cycle may occur two or three times, requiring the user to consistently select the same stimulation montage to be selected for use in treatment. The system may then use the user's preferred stimulation montage during the delivery of treatment. In one embodiment, the continuous left-right or other adjustment of the field montage is selected using a set of weightings for each stimulation channel defined in a lookup table.

[0137] In the embodiment shown in FIG. 5c, the screen does not provide a visual indicator of the field location, including the highlighted circle (although the percentage amplitudes used in each of the three "columns" of the matrix are shown at the bottom of the screen). When this signaling was removed, subjects were less confident in reporting where the field was. Providing a real-time visual indication of the stimulation field characteristics, in addition to the stimulation-evoked sensations perceived at the skin, can a) enhance and facilitate subjective discrimination of the field location and movement, and b) allow the user to understand the positioning settings that are optimal for them.

[0138] FIG. 5d shows a “Select” device management screen 222 with a set of buttons provided to accommodate left-right adjustment of the stimulation field. For example, three buttons allow the field to be moved from left to center to right, with this location visually indicated by three virtual oval indicators. The selection control allowed for the selection of only an initial subset of pads in the stimulation matrix (e.g., one of the columns of the stimulation matrix) while restricting stimulation to other subsets of pads on the matrix (e.g., the subset of pads activated was limited to one of the columns of the matrix at a particular time). In one embodiment, a set of user controls is defined with each control associated with a particular stimulation montage, and the controls are mutually exclusive such that only one control can activate a selected montage and associated set of stimulation pads.

[0139] 5e shows a "Switch" device management screen 224 in which the user can switch the stimulation fields of each column of the stimulation matrix by selecting one of the controls that individually switch each electrode pair in the column between at least an on and off state. Switching can also be performed to provide a series of steps between OFF and several amplitude weights (e.g., [off, 10%, 40%, 70%, 100%]). In an embodiment, the "switch" control is programmed differently from the "select" control, with the former allowing only one column to be selected at a given time and the latter defined to allow adjustment of more than one column of the stimulus matrix. If switching allows multiple weights, the brightness of the circle used on the display to indicate the on / off state can also appear larger or brighter with larger weighting factors.

[0140] In one embodiment, at least one set of switching user controls is defined such that the controls adjust the on / off state of a selected set of stimulator pads, while in another embodiment, the switching user controls adjust both the state (on / off) and the amplitude weighting of a selected set of stimulator pads. In one embodiment, the set of switching user controls includes at least two user controls that adjust the state (on / off) or characteristics (e.g., amplitude weighting) of at least a first and second set of stimulation pads, and the switching of the at least two user controls is not restricted to being mutually exclusive.

[0141] 5f shows an "LR Slider" device management screen 226, implemented as three slider controls, each controlling a property such as amplitude for a set of stimulation pads, such as a column of a stimulation matrix. These can be slid by the user to adjust the property value, which is set to a value within a defined range (e.g., between 0 and 100), and adjust the stimulation field so that stimulation occurs in the left, center, or right region of the stimulation matrix. In an embodiment, if a stimulus matrix has more than two stimulus columns defined for it, using sliders for each column becomes cumbersome. This embodiment can also be difficult because, like the "Switch" and "Select" screens, the user can provide stimuli to the left and right matrix areas, but not to the center. This creates two separate areas of stimuli and complicates field selection compared to the "Direction" screen.

[0142] "Toggle" was preferred by some users because it allowed multiple columns to be toggled simultaneously, giving the user more control and a more pleasing sensory experience than "Select" (ostensibly because multiple columns could be activated at the same time). However, said "Toggle" posed user interface challenges due to the multiple combinations of three on / off buttons, which increased further when the buttons could be toggled between off and several intensity levels. Even using three sets of channels on / off could frustrate subjects. "Selection" required the user to select from only one column of a matrix (radio style). Users liked it because it was easy to implement, but it may not have provided the best sensation and did not recruit neural activity. These considerations support using a "directional" user interface with the ease of use associated with "Selection" with the ability to weight multiple columns and use five stimulus montages that allow the stimulation field to be adjusted by simply pressing two "directional" controls.

[0143] In one embodiment, five zones define steps for moving along the left-right axis of the matrix. The corresponding labels are (indicated) Left, Center Left, Center, Center Right, and Right. There are also "Overall" settings that set all three circuits equally, such as 75%-80% or 100% (although because all three circuits provide energy, 100% may result in too strong and uncomfortable stimulation intensity when transitioning from one or two circuits). Alternatively, set the center pad circuit at 100% and the pads on the left and right rows slightly lower (e.g. 80% or higher). Or, for example, set a lower weight value on only the left or right column to avoid stimulating the muscles. If, instead of left and right, the terms "towards the shin" and "towards the calf" are used in the App 21 software, this will be switched depending on which leg the user has indicated is being used to deliver treatment.

[0144] When operating the system according to the field steering method described above, the stimulation intensity can be initially set by the user in a location setting (e.g., left) by using the intensity control buttons to select a stronger stimulation level that is below the user's pain threshold. After evaluating different field steering settings using SaphLocate and selecting the stimulation montage to be used during treatment, the user can adjust the intensity setting higher or lower to provide a comfortable stimulation level during treatment.

[0145] While the field steering controls described above provide the most obvious advantages when using a 3-5 row stimulus matrix, the other controls may provide advantages when a larger number of stimulus pads are used in the matrix, or when more complex stimulus montage templates are used. Figure 5g shows an alternative embodiment of the "Slider" management screen 228 with three different slider controls. The "Site" control adjusts the site of amplitude maximum and can be set to control the left-right axis field of the stimulus pads, the "Spread" control adjusts the number of adjacent pads that are activated, and the "Attenuation" control adjusts the sharpness of the falloff of the weights from the point of maximum amplitude. When used in combination with a stimulation matrix such as that shown in Figure 7d, the "site" control can adjust the column or columns (e.g. 4 and 5) from which the stimulation circuit with maximum stimulation occurs, the "spread" control adjusts the number of adjacent columns (e.g. 2-3 and 6-7) that provide active stimulation channels, and the "attenuation" control increases the attenuation of amplitude weighting through channels as they move away from the maximum channel (e.g. 2 (85%) and 3 (60%)).

[0146] Figure 5h shows an alternative embodiment of the "Direction" device management screen 230 with a direction "joystick" control, as well as "spread" and "attenuation" controls. As shown in Figure 7e, the defined stimulation montage at the top of the matrix provides anode-protected stimulation using three cathode channels (C1, C2, C3) distributed across three stimulation pads surrounded by ten anode channels. The joystick control can adjust the position of the placement of the active channels within the stimulation matrix. The "Spread" control adjusts the number of active channels on the left-right axis of the matrix (e.g. using 1-3 rows of cathodes), while the "Attenuation" control adjusts the discreteness of the stimulation field by setting the attenuation of the magnitude of weighting away from the primary stimulation channel. In the example where the joystick sets the primary channels near the center of the matrix (left-right axis), "C2" and "A2" will be weighted relatively more highly than their adjacent anodes and cathodes to the left and right as the "Attenuation" parameter is decreased. In addition to the pads immediately adjacent the cathode, the anodes may also be provided on non-adjacent pads separated from the cathode by at least one intervening pad. In further embodiments, the user may be able to select several stimulation montages of various pre-set shapes, which can be moved to different positions in the stimulation matrix using a joystick. Stimulation montages in the lower half of the matrix have a reduced spread parameter to spread the stimulation field less (along the left-right axis). In embodiments, "spread" and "attenuation" controls may be provided to adjust the field along multiple axes.

[0147] 5i shows an alternative embodiment of the stimulus montage field control screen 232 that includes a touchpad controller that allows the user to adjust the characteristics of the stimulus field by gestures such as "dragging" the shape with a finger in a direction that adjusts the position of the field within the stimulus matrix. Other gestures such as pinching the shape decrease the spread of the stimulus field, or spreading two numbers apart will increase the spread of the stimulus field. The intent actions are associated with algorithms that make corresponding adjustments to the stimulation field by activating additional stimulation channels, deactivating stimulation channels, adjusting the weights of activated channels, moving the position of the set of active channels to a different location on the matrix, or selecting a montage from a defined set of montages that correspond to the adjustments.

[0148] In an embodiment, the virtual stimulation map provided by the virtual module 50a of the digital ecosystem module 50 allows the user to control the stimulation module to spatially steer the stimulation field in 2D or 3D space. For example, the user can adjust the position and shape of the stimulation field image displayed on a grid or leg model. The user can "drag" the center of gravity of the field to a desired location and "squeeze" or "push" the field away from a particular area. The device can adjust the stimulation in real time according to the user's gestures, which are translated into corresponding stimulation parameters. For example, if the user drags the center of gravity of the stimulation field to the right on the smartphone display, the stimulation energy will shift correspondingly to the pads on the right side of the matrix. If the user presses a virtual button that corresponds to narrowing the field or increasing the depth, which can be achieved by activating electrodes using "protect" or by increasing the interelectrode distance (thereby increasing the field depth).

[0149] The SaphLocate feature of the disclosed invention provides the advantage of allowing a user to adjust stimulation field characteristics in an intuitive, user-friendly manner utilizing a set of predefined stimulation montages, and a range of stimulation montages that can be selected or adjusted in a limited number of ways, which is preferable to requiring a user to attempt to individually adjust stimulation parameters for each channel or many possible stimulation circuits.

[0150] Finally, Figure 5j shows an "advanced" screen 234 that may be provided by the user interface module 48 to users with selected permissions, such as a physician. It may only be provided on certain user devices, such as the physician's computer 20c. In an embodiment, controls are provided to allow the user to select "no paresthesia" or "paresthesia" and the location where it occurred, "toes," and these entries are saved in the log data along with the montage profile information. Although the drawing shows "paresthesia," the button is a drop-down menu with other options, in this case "none." The user can also indicate any issues occurring with the selected stimulation montage, such as "muscle stimulation", "pain", "discomfort", or other side effects. Log information for a series of montages can be displayed in a table, allowing the clinician to review the information and evaluate the results. This screen also allows control of the step size of the changes applied to the montage. For example, the weight adjustment used to change the field position can be set (e.g., 10% or 20% steps). The magnitude of the amplitude change can also be set (e.g., amperes). In an embodiment, the montage can define the stimulation signal pulse duration (e.g., 2000 uSec) for the primary channel to be different (e.g., longer) than that provided in the non-primary channels. This can increase the likelihood that nerves below the primary channel will receive relatively more stimulation than the sideband channels, reducing the risk of stimulating adjacent muscle or nerve tissue. In interferometry, the montage can be set for different channels with different pulse rates or patterns. In an embodiment, in addition to moving the field position, button controls with drop-down menus are used to at least bias the field direction to the "left" or "right," but can also control bias in the "proximal" or "distal" directions or to increase depth. The virtual field provided by the montage can be calculated by the virtual module 50a and displayed to the user. In an embodiment, if the user deactivates a channel to avoid muscle stimulation, the stimulation module 42 will distribute the associated cathodic or anodic charge across the remaining active pads.

[0151] Automatic adjustment of stimulus field position and geometry. The system allows user selection of a stimulus montage to be used with a selected stimulus matrix as shown in Figure 3a. In an embodiment, the system 10a also supports a curated procedure to assist in this selection. In one embodiment, the SaphLocate evaluation protocol includes one or more of the following steps when the user selects the program button "P", as shown in the field control screen of Figure 5c: A) Ramp stimulation amplitude on two or more active channels. Obtain user input (e.g., button press) that flags at least one of the following subjective measures: skin sensation threshold, nerve recruitment threshold, level of intense but tolerable sensation, level of discomfort (e.g., level considered intolerable for 10-30 minutes of stimulation), level of pain onset (e.g., level painful even for a few seconds). At the end of the ramp, where the intensity of the stimulation signal is at its maximum and the user indicates pain, the stimulation intensity is reset to zero or the channel is turned off. Objective measures such as SNAP can identify the nerve recruitment threshold rather than or in addition to subjective measures. B) The present ramp protocol is performed for channel set #1 (e.g., C1 vs. A1 in Figure 6a; active channels are not shaded), and then for each of the sets of channels defined for the remaining columns of the matrix moving left-to-right or in random order (e.g., stimulation channel set #2 (C2 vs. A2 in Figure 6b)) and channel set #3 (e.g., C3-A3 in Figure 6c)). C) The ramp protocol is performed for each stimulus montage (and corresponding weights) in a set (e.g., 5) of stimulus montage candidates moving from left to right or in a random order. D) The Ramp Protocol is performed "on the whole", which includes all columns of the matrix. E) The present ramp protocol is performed for two diagonal stimulus montages, such as C1-A3 or C3-A1 in Figure 6e. F) This ramp protocol is performed for each individual circuit of the stimulation montage that can be used during stimulation (e.g., C2 vs. A1, then C2-A2, then C2-A3). (For example, the full montage is one cathode used in combination with three anode contacts (C2 vs. A1 and A2 vs. A3, in combination). G) This ramp protocol is performed simultaneously or sequentially on independent circuits of the stimulation montage (C1 vs. A2 and C2 vs. A3 in Figure 6k).

[0152] Since all six of the stimulation pads of the matrix can be operationally configured as anodes or cathodes, the set of potential "channel" combinations evaluated should be done in a limited manner, as there are many possible permutations. The "programming" process should be done "intelligently" to provide a practical algorithm that evaluates only permutations relevant to the limited set of selected stimulation montages. In a preferred embodiment, steps C and D are performed and the stimulation montage with the lowest neural recruitment threshold is selected for treatment.

[0153] The results of this ramp assessment can be stored in a look-up table (as a table or heat map of the sensory measurements obtained in step "A") and displayed to a user, such as a patient or a medical professional. In embodiments, the stimulation pad montage that produces the highest score for the desired characteristic can be selected. For example, the stimulation montage that corresponds to the lowest threshold of neural recruitment, or the greatest difference between neural recruitment and the level at which pain is experienced, can be selected by the user or by the SaphLevel algorithm. Once various pairs of stimulation pads are activated as channels, such as pairs of two pads from a set of six or more pads, a table or heat map can be used to present the user with data on which intensity levels are associated with different sensory measures.

[0154] In one embodiment, the field adjustment algorithm uses channel weighting values ​​that allow for a left-to-right or right-to-left transition when the user presses the control button labeled "P" in FIG. 5c, whereby the sequence of stimuli is configured to be different using selectively activated zones. This montage is perceived as moving from the left to the center to the right region of the stimulation matrix, but there is no abrupt jump in the perception of the skin stimulation intensity of the region under the stimulation pad that occurs at the transition between zones, i.e., the perceived stimulation intensity is preferably similar. This allows the user to accurately evaluate and compare different montages to select a preferred montage (e.g., strongest recruitment of the target nerve while minimizing undesirable effects of stimulation) for later use during the delivery of treatment. During evaluation of different stimulation montages, weight values ​​are adjusted to be non-zero in the channels outside the primary circuit (where stimulation amplitude is highest), but these non-primary stimulation channels may be set to zero when the actual therapeutic stimulation is delivered (i.e., if the two middle stimulation pads (e.g., C2, C3 in Figure 7e) are primary, the left and right circuits are zeroed). When a matrix such as the one used in Figure 7e is used, the algorithm may move preselected stimulation montage shapes to different regions of the stimulation matrix.

[0155] Hardware field steering. Figures 6a, 6b and 6c show an embodiment of the stimulation montage realized as a left, center and right stimulation field, respectively. Each column of the stimulation matrix includes one proximal anode (e.g. A1, A2 or A3) and one distal cathode (e.g. C1, C2 or C3). Alternatively, the top electrodes may be designated as cathodes and the bottom set of electrodes may function as anodes. The first circuit includes the leftmost pair of pads as shown in Figure 6a (active = no shading), while the center and rightmost pairs are inactive. The user may also activate the center pair of pads as shown in Figure 6b, or the rightmost pair of pads as shown in Figure 6c, while the other two sets of channels are disconnected. This allows the field to be moved from left to center to right.

[0156] Instead of adjusting the amplitude weighting values ​​using a sequence defined for each of the three columns of the matrix, the "slider control" can provide stimulation using an alternative sequence that moves the field from left to right using circuits defined with channels from two or more columns of the matrix. For example, the sequence that transitions from left to center can include the stimulation montage defined by Figures 6a, 6d, 6f, 6l and then 6b. In other words, the stimulation montage sequence does not need to change incrementally from using one circuit (one anode and one cathode) to using two circuits (two anodes and two cathodes) when adjusting the field from left to right. Also, although Figures 6a-6n show the anode at the top, the cathode may be at the top of the pad.

[0157] With regard to generating the stimulation signals that contribute to shaping the stimulation field, the stimulation module 42 may utilize a circuit design that uses ganged arrangements of stimulation channels, independent stimulation channels, or a mixed arrangement.

[0158] Independent Channels. In an embodiment, the system is typically configured to provide an independently controlled stimulation signal to each stimulation pad. When using a triangular arrangement of six stimulation pads distributed across the top and bottom of the stimulation matrix 14, these can be realized as six independent channels of stimulation. This requires that the stimulation module 42 be able to generate multiple stimulation channels, either by a multiplexing circuit capable of driving N channels with sufficiently rapid switching, as can be done using multiple stimulus generators, or by other means known to those skilled in the art.

[0159] Ganged embodiments. Ganged embodiments are realized when a signal from a single stimulation channel is provided through two or more stimulation pads (the two or more stimulation pads are electrically combined).

[0160] In one embodiment, the stimulation module 42 is configured to provide or switch between independent stimulation channels or ganged channel arrangements, or a combination thereof (e.g., given a circuit with one anode and one cathode, the user can activate another channel electrically connected to either the anode or cathode, configurable via an electronic switch circuit).

[0161] While hundreds of embodiments are possible with the system using permutations of independent, interlocking, or mixed circuits, the following examples are described using two, four, or six independent stimulation channels. When stimulating nerves running along the limbs, a limited number of predefined channels allows the user to easily tailor the stimulation field to their preference. Thus, the system can only use the channels defined in Figures 6a, 6b, and 6c (although anodes and cathodes may be switched so that the cathodes are at the top of the matrix). Even if all 14 montages shown in Figures 6a-6n were included in the candidate set of montages, this would still be preferred over controlling each channel individually.

[0162] Since any combination of the six pads can act as cathodes and anodes, each of which can use a weighting value, a very large set of possible current steering configurations is possible. Briefly, in one embodiment, a set of predefined pairs of stimulation channels (e.g., C1-A1, C2-A2, C3-A3) serve as a candidate set of stimulation montages that can be evaluated and / or used during treatment.

[0163] The following examples show that the triangular pad arrangement allows the fields to go from left to right and be arranged vertically, or horizontally, or diagonally. These are intended to be used with independent channels, although ganged or mixed montages (having both independent and ganged channels) are possible variations.

[0164] In one embodiment, both the center and left columns of the matrix are "activated" to provide stimulation signals constituting a center-left stimulation montage, as shown in Figure 6l, or the center and right stimulation pad pairs are used to provide a center-right stimulation montage, as shown in Figure 6m. By sequentially providing a stimulation montage selected from the sequence of stimulation montages shown in Figures 6a, 6l, 6b, 6m, and 6c, the user can adjust the stimulation field position across five laterally displaced zones defined from the left to right extremes of the stimulation matrix. The user can then select a zone from a group including left, center-left, center, center-right, and right.

[0165] Figures 6d and 6e show an embodiment where the field crosses diagonally between the left and right sides of the matrix. The narrower field increases the likelihood that the nerve will be recruited while using fewer electrodes than an embodiment like Figure 6k. If the current delivered using two pads versus four pads is kept constant, using only two pads will result in less area being used to deliver stimulation, and therefore fewer channels will result in higher current density. Figures 6d and 6e can also provide increased current density (anodes) compared to those shown in Figures 6f and 6g. A narrower diagonal field may also reduce the risk of inducing activation of collateral muscles. In one embodiment, as shown in Figure 6f, C1 (cathode) and A1 / A2 (both functioning as anodes) form a circuit slightly proximal to the circuit of Figure 6l on the leg.

[0166] In one embodiment, if a subject shows good recruitment but also shows calf muscle activation, an additional set of stimulation montages may be provided that allows the user to adjust the position of the field in new ways, such as allowing the position adjustment to be more proximal and away from the calf. For example, if a subject prefers stimulation from the middle row (e.g., C2-A2) but reports calf muscle activation, instead of asking the user to move the entire stimulation matrix up the leg, the stimulation program may attempt to shift the field more proximally. For example, in another embodiment not shown, the leftmost (C1) or rightmost (C3) electrode functions as a cathode, and all pads on the top half of the matrix (A1, A2, A3) function as anodes forming a circuit that allows for the generation of stimuli slightly closer to those generated when C2 is used. This proximal shift in the location of the leg stimulation field allows stimulation to be delivered without stimulating muscles such as the calf muscles. Alternative stimulation montages such as 6d, 6h, or 6j can be attempted, as they both involve stimulation of the central zone without the stimulation pad distal to C2. Alternatively, both the anode and cathode can be assigned to the upper triangle, as shown in Figure 6n, and furthermore, only the upper part of the triangle is activated. Thus, in an embodiment, in addition to a montage that moves the field along the left-right axis, there is a set of stimulus montages associated with "shift up" or "shift down" options, which will adjust the field more proximally or more distally compared to the current stimulus montage.

[0167] Additionally, the montages shown in Figures 6i and 6j allow for downward and upward field adjustments to that shown in Figure 6h. Thus, while the field steering manager shown in Figures 5a-5e shows control for moving the left and right bias of the stimulation field, the stimulation matrix using the three-pad triangle set disclosed herein also allows the user to adjust proximally and distally along the limb axis when up and down controls are provided so that the user can toggle that parameter.

[0168] In the embodiment shown in Figure 6e, channels C1 and A3 form a diagonal circuit extending from the bottom left to the top right region of the stimulation matrix. This stimulation montage may be advantageous over strictly longitudinal fields (e.g. C1-A3) because a) the shape / direction of the field, especially in the cathode region, may be more likely to intersect the nerve along the axis of the user's limb, but not directly below the cathode, and b) the anode electrode may reduce the hyperpolarizing effect on different regions of the modulated nerve (as it prevents potentials from traveling proximal or distal to the stimulation site). The diagonal montage may be advantageous when attempting to record SNAP above or below the stimulation electrode.

[0169] In one embodiment, multiple stimulation montages may be selected during stimulation delivery, or different channels of a stimulation montage may provide different stimulation signals. For example, an "effective" stimulation frequency, such as 20 Hz, may be provided by a combination of a first diagonal channel C1-A3 providing a 10 Hz pulse train signal, and a second diagonal channel C3-A1 providing a second 10 Hz pulse train signal. The two signals are offset by half a cycle and combined to produce a 20 Hz signal in the commonly stimulated tissue from both channels. Without being bound by theory, one advantage of this stimulation protocol is that the neural target is stimulated using two different stimulation vectors, one of which may be more optimally aligned to recruit the nerve. Also, the lower current density at each electrode location may minimize cutaneous nerve stimulation. In addition, both 10 Hz and 20 Hz have been shown to produce strong therapeutic effects stimulating the saphenous nerve in an animal bladder filling model (see Yoo and John, U.S. Patent No. 9610442). Thus, even if only one channel is successful in recruiting the nerve, efficacy should still be obtained.

[0170] In an embodiment, the stimulation protocol may select a stimulation montage from a set of two or more stimulation montages that are used at different moments. This may help to reduce the risk of skin irritation compared to using a single circuit for the entire treatment session. In addition, if a user indicates that they "like" two different stimulation montages, switching between these during treatment stimulation may improve if one of the montages gives a better neuromodulation of the SAFNs, even though this is not perceived by the subject.

[0171] Turning now to Figures 6h-6j, it should be noted that the stimulation matrix not only allows for longitudinal displacement (6h being more proximal), but also in Figure 6h creates a longitudinally more compact and broader stimulation field, which may be shallower than that provided by that shown in Figure 6b. In an embodiment, a stimulation montage with a deeper field path may be selected in response to the user toggling a control to adjust the stimulation field "deeper."

[0172] Finally, FIG. 6n illustrates an embodiment in which both the upper and lower sets of stimulation pads on the upper and lower halves of matrix 14 include both anode and cathode assignments. Stimulation circuits can be defined and established only within the upper or lower set of stimulation pads, and although the resulting stimulation field may not go as deep below the skin surface as the inter-pad distance is greater, this may be sufficient. This compact stimulation montage is more likely for target nerves in the arms or legs that are shallow enough to the skin's surface. Also, a shallower stimulation field may offer advantages such as localized stimulation to the area of ​​the skin / pad interface if the stimulation signal is given during the post-treatment stimulation interval and is designed to prevent bruising of the skin by increasing blood flow to the area under the pad.

[0173] Instead of a selected channel being active and the other channels being inactive, all three pairs of pads (C1-A1, C2-A2, and C3-A3) are active, forming three separate circuits, with amplitude weighting set so that one of the three pairs of pads is at a higher amplitude ("primary") and the other channels at a lower amplitude ("non-primary"). Human testing was performed on a small group of 13 subjects, and the results showed that nearly all subjects were able to identify when the stimulation field transitioned between the five zones when these were presented using five sets of amplitude weighting values ​​in three columns of the matrix. Thus, as disclosed, in an embodiment of the Saphlocate function, all channels are on, rather than active or inactive, but the selected channel is set with a higher amplitude weighting to energize the maximum stimulation field at the selected location.

[0174] Multimodal field adjustment. Displaying information about the stimulation field graphically can help the user to better distinguish or predict different stimulation field geometries. For example, a highlighted circle on the right or center-right side of the display can focus the user's attention to the skin under the right side of the matrix, as shown by the display shown in Figure 3b. While useful for a small set of pads, such as the three pairs of circuits that define the three columns of the stimulation matrix (e.g., A1-C2, A2-C2, A3-C3), a more detailed display can be useful when more complex stimulation montages are defined as possible permutations such as those shown in Figures 6a-6n. In an embodiment, the relative weight or stimulation signal strength of the signal output at each stimulation pad is visually represented using a heat map of the stimulation matrix and / or displaying a numerical value at each pad location corresponding to the intensity of stimulation. A color-coded map may be generated by the user interface module 48 to show the user the intensities provided at the individual pads or the calculated field strength of a vector field integrated over the modeled stimulation field calculated by the virtualization module 50a.

[0175] The perception of both the stimulus and the changes in the stimulus can be enhanced by manipulating the user interface module 48 to provide signals in the auditory and / or visual modalities via the user device 20a or the neurostimulator 12. The SaphLevel and SaphLocate software programs are configured to provide reinforcement signals such as a) modulated sound and / or light stimuli (e.g., light modulated at the same frequency and synchronized with the stimuli), b) auditory or visual cues that align with changes in the stimulus montage (e.g., as each of the five settings is selected, they are accompanied by a tone cue), c) visual stimuli provided on the housing or screen of the user device indicating the area of ​​stimulation, and d) sensory cues in the form of volume or light intensity that are adjusted depending on the amplitude / intensity of the stimulation signal.

[0176] Weighting values ​​for the stimulus montage. In an embodiment, SaphLocate TM Features include the use of appropriately selected stimulation channel weightings that allow for adjustment of the stimulation field geometry to meet criteria such that position changes are generally perceived or occur smoothly, and potentially allowing subjective evaluation and comparison of two or more stimulation montages. When comparing different candidate stimulation field geometries, abrupt transitions in perceived intensity can be problematic because they can prevent the user from assessing important stimulation-related properties, such as determining the presence of evoked paresthesia associated with neural recruitment.

[0177] Features that the user can evaluate to determine the stimulation montage may include one or more subjective sensations, such as the subjective intensity of the stimulation field; the amount of unwanted muscle stimulation; the comfort of the skin sensation beneath the stimulation pad; the quality of the stimulation beneath the stimulation pad (e.g., tingling, pulsating, sharp / dull, etc.); the presence or absence of nerve recruitment; the intensity of nerve recruitment; areas of paresthesia; the quality of the stimulation-induced paresthesia (e.g., vibration, tickling); overall comfort during stimulation; the presence or absence of pain or discomfort; or other therapeutic characteristics.

[0178] In one embodiment, the objective of the invention is to have the field provided by a first stimulation protocol setting (e.g., using two channels) perceived as being approximately similar in intensity to a second setting (e.g., using four or more channels), while allowing the user to perceive a change in the geometry or position of the stimulation and to allow the user to determine which geometry or position is preferred. Even if the fields delivered by the first or second stimulation montages provide similar target neural recruitment function, differences in perceived comfort or tolerability of the stimulation may dictate the preferred montage for use during subsequent delivered treatments.

[0179] The sudden jumps (e.g., in perceived intensity) that occur when a user adjusts between different stimulation field settings hinder the user's ability to evaluate changes in subjective measures due to changes in stimulation location ("zone") or changes in intensity. The goal of the present invention is that a two-channel stimulation field is not simply perceived as weaker (or stronger) than a four-channel stimulation field because more stimulation pads provide stimulation signals, causing more activation of skin receptors or causing jumps in the vector field. Large perceived jumps can hinder the user's ability to compare the differences between the two montages in recruiting nerves.

[0180] The advantage of using weights to adjust signal characteristics (e.g., amplitude) allows the geometry of the stimulation field to be adjusted across different stimulation pad combinations without temporary jumps in intensity or other discontinuities that would otherwise make it difficult for the user to compare alternative stimulation patterns (or even prevent accurate comparisons). Often weighting values ​​may be applied to amplitude, but these may also be adjusted for other stimulation parameters such as pulse duration. Weighting values ​​can also be applied to the duration of a channel's stimulation pulse so that the perceived intensity does not cause large changes between different stimulation montages. Doubling the pulse width results in the same current density but doubles the charge delivered over time, potentially increasing the intensity or perception of the stimulation.

[0181] Another advantage is that if weighting values ​​are used in the stimulation montage used during the evaluation of candidate montages, improved stimulation can be provided during subsequent delivery of therapy. For example, using weighting factors in channels adjacent to the primary channel (i.e., the channels with the greatest intensity) can also find optimized stimulation patterns not found otherwise because providing energy to adjacent channels a) supplements the energy provided by the primary signal and may provide stronger neural recruitment, b) supplements the energy provided by the primary signal and neural recruitment occurs that would not occur by using only the primary channel for stimulation, and c) allows recruitment to occur with the primary channel's energy at a smaller amplitude (due to vector field summation or other aspects that enhance the ability of the primary channel's stimulation signal to modulate the nerves).

[0182] One SaphLocate feature that can be used to adjust stimulation channel weightings relates to the inventors' discovery that when adjusting the geometry of the stimulation field (e.g., when transitioning from a left-most to a right-most stimulation configuration), the perceived intensity of the stimulation (or other subjective sensation) can change or "jump" significantly. Thus, SaphLocate provides benefits such as increasing the user's ability to select between different field geometry candidates using a lookup table with channel weightings that reduce these perceived jumps between potential stimulation settings.

[0183] A subjective discontinuity between two stimulation montages may occur when a first stimulation circuit (e.g., the left pair of stimulation pads (C1-A1)) is used in combination with a second pair of stimulation pads (C2-A2) forming a second stimulation circuit. When adding a stimulation channel, the perceived stimulation intensity may "jump" if the stimulation protocol uses a weighting strategy designed to maintain equal total current (integrated over all anodes or cathodes of the stimulation matrix). The problem here is that if the target neural recruitment threshold is 30 mA and only the left circuit uses 40 mA, then when the center circuit is added, both channels are set to 20 mA, suddenly the subject will not feel paresthesia because the nerve stimulation current is below the target neural recruitment threshold. Thus, a 4-channel embodiment should use a set of channel amplitude weighting values ​​that suppresses this type of undesirable outcome (e.g., use a weighting strategy that keeps the stimulation current above the recruitment threshold).

[0184] In this example, the amplitude of the two stimulation signals can be adjusted to compensate for the difference in pad surface area associated with the two circuits to match the total current provided by the surface area of ​​the pads used by one circuit of the stimulation. Thus, if the surface area of ​​the stimulation pads is doubled, the weighting adjustment reduces the channel weighting by 50%.

[0185] In the table below, a value of 100% (i.e. weighting factor 1.0) indicates that the stimulation signal (e.g. 20 mA) is applied without attenuation, whereas a value of 50% (i.e. factor 0.5) indicates that the stimulation signal current of that stimulation circuit will be attenuated by 50% (e.g. 10 mA). Weights can also be defined for individual channels. In one embodiment, a set of weights is configured to maintain total current, as shown in the table below with sample weighting factors used when transitioning from a two-channel to a four-channel stimulation montage. In contrast, transitioning from a 100% weighting value in the left channel to 100% on both the left and center would maintain current density over a larger area of ​​tissue, but would result in a large increase in perceived stimulation intensity. Either scenario would prevent a user from making a comparison between the two stimulation montages.

[0186] The weighting values ​​adjust the intensity of the stimulation such that if the user increases the value of the stimulation signal intensity parameter (e.g. from 30 mA to 70 mA with a possible range of 0 to 100 mA), this new intensity value will be used to set the amplitude of the signal provided at each stimulation channel of the circuit after being multiplied by the channel's weighting factor, which in this example is the "gain adjustment factor".

[0187] [Table 1]

[0188] In the table above, the amplitude of the signal provided using four channels (e.g. if the user selects left center or right center) is reduced by 50% (channel weighting = 0.5) to maintain the total current provided by the stimulus matrix relative to the amplitude of the signal provided by any of the two channel montages (e.g. left, center, right). Similarly, in the case of six channels, each circuit provides an amplitude adjusted by a channel weighting value of 33% (this is 33% of the amplitude provided if any of the three circuits of the channel are provided alone). Using 33% may be a weighting value that is too low, especially at low amplitudes, as this may cause the stimulation signal amplitude to fall below the threshold of sensation or recruitment, and / or due to a non-linear slope (intensity curve) of perception. The "AN" setting cannot be compared with the other montages in the table. Weighting values ​​closer to 75% (and in the range of 50%-85%) in each channel are more feasible.

[0189] Also, when adjusting between stimulation geometries, instead of adjusting the weighting values ​​corresponding to the amplitude gains, the average duration of the stimulation pulses may be adjusted to compensate for an increase or decrease in the number of stimulation pads providing one or more stimulation signals. For example, when increasing stimulation channels from 2 to 4, weighting factors can be applied to stimulation signal characteristics, such as pulse duration, which can be reduced to maintain a similar perceived signal strength. For example, the weighting factors can be adjusted proportionally or otherwise (e.g., a 40% duty cycle can be reduced to 20%).

[0190] As noted, we have found that the strategy of dividing the total current (e.g., by the number of channels or stimulation pads) does not, in fact, yield the desired result of increased smoothness. The above table maintains the same total current / charge delivered when moving between configurations of stimulation pads, but appears to have the drawback of causing large changes in perceived intensity between stimulation montages. This hampers the ability of subjects to compare between candidate montages and select a preferred montage that will successfully modulate the SAFN (e.g., strongest or most distal sensation of paresthesia while minimizing collateral stimulation).

[0191] In studies conducted by the inventors, it was determined that changes in field size (and thus changes in the integrated size and shape of the stimulated surface area, and possibly in the strength of the vector field) due to current delivered by different numbers of stimulation pads, or corrections for certain modifications that maintain the total current, do not appear to be proportional to changes in the subjective intensity of the stimulation signal. Maintaining the total current delivered constant does not appear to correlate with a smooth perception of intensity across different combinations of channels. In one embodiment, this strategy is avoided when setting the weighting coefficients: instead, they are selected such that the change in perception of stimulus intensity for different stimulus geometries is less than a "maximum geometry change threshold" that has previously been found to be acceptable in a sample of subjects.

[0192] Without being bound by theory, several factors may contribute to what a subject experiences when the field strength and / or geometry are adjusted. These may also explain why using weighting factors set to maintain the total current delivered by the matrix across stimulation montages using different numbers of stimulation channels is not a successful strategy. One factor may be an issue of skin sensation threshold. For example, if a subject's cutaneous sensation threshold is 8 mA for a particular set of electrodes and the amplitude of the first stimulation circuit is 10 mA, then the stimulation field is above that threshold. If a second set of electrodes is added to the stimulation montage and the weighting factors are adjusted to maintain the net total current (i.e., the signal is reduced to 5 mA per channel), this will be below the sensory threshold and will not be perceived through the skin by the subject. Rather, the weighting factors may be adjusted in relation to the cutaneous sensation threshold, the target nerve recruitment threshold, the perceived intensity, the sensed neural activity, or other considerations.

[0193] In one embodiment, in contrast to correction factors that maintain the total current delivered through the stimulation pads, two characteristics of the stimulation weights are provided to reduce the risk of subjective sensation jumps when transitioning between stimulation montages: a) the weights of channels adjacent to the primary stimulation channel are not set to zero, but are set to provide lower amplitude signals, and b) non-primary channels that are not adjacent (i.e., may be separated from the primary stimulation circuit by at least one intervening stimulation pad) are not set to zero, but are set to provide reduced amplitude (e.g., current) stimulation. For example, in FIG. 6a, the primary stimulation circuit is A1-C1 (i.e., the left stimulation that provides the highest amplitude stimulation signal), and the non-primary stimulation channels are formed by adjacent anode-cathode pairs, A2-C2 and A3-C3, of the stimulation matrix 14.

[0194] In one embodiment, the left stimulation field defines a primary stimulation circuit (weighting=100%) that is complemented by a small amount of non-primary stimulation provided by the non-primary stimulation channels. For example, the weighting is as shown for the A1-C1 (100%), A2-C2 (87.5%), and A3-C3 (75%) channels, respectively. In another embodiment, the three weights used for the "left" stimulation montage are 100%, 80%, 67% and the reverse for the "right". Alternatively, weight values ​​such as 100%, 70%, 35% or 100%, 50%, 20% may be selected. Thus, in an embodiment, all three circuits are active in all montages and the movement of the field is caused by changes in the weights to provide maximum stimulation at different positions.

[0195] [Table 2]

[0196] Another advantage of using non-zero weighting values ​​on stimulation channels adjacent to the channel to which the maximum stimulation field is provided is that instead of a non-primary stimulation channel going from 0 to a value such as 94%, increasing from 50% to 85% or 70% is a smaller increase, allowing for a smoother transition (and reducing the risk of the channel falling below threshold before the increase).

[0197] In an embodiment, the user is surveyed and if he indicates that he does not perceive a clear change in the position of the stimulation field, or that the change is not perceived as occurring smoothly, the weightings are adjusted accordingly (e.g., the weightings of different channels could be separated by a greater amount to make the change more apparent).

[0198] Rather than using a lookup table, the weights for the various stimulus montages can be calculated using a formula such as: Left circuit Amplitude=Amp*(BaseAmpW-(Location*SlideFalloff) (&Right Pad Amplitude =Amp*(BaseAmpW-((4-Location)*SlideFalloff)) "Amp" is the amplitude of the current parameter limited according to the range of the D / A buffer (e.g. 0-80mA), "BaseAmpW" is the percentage of the weighting value of the amplitude of the primary channel (e.g. Left = 100%), "Location" is assigned values ​​(e.g. 0, 1, 2, 3, 4) based on the montage selected by the user, and "SlideFalloff" defines the slope value of the attenuation on each non-primary channel (e.g. 6.25%). SlideFalloff can be adjusted to be obviously steeper or non-linear (e.g. raising the exponent to 1.2).

[0199] In one embodiment, the set of stimulation montages is realized as eleven transverse zones, left and right, and the weightings of the left circuit (C1-A1) are set to each of the following values ​​when the stimulation montages ("zones") are set by the user as follows: [Table 3]

[0200] If the "far left" montage is selected, the matrix left circuit will have the least amplitude attenuation and the greatest output according to the formula above. Alternatively, none of the weights can be allowed to fall below a value such as 40%, so that the left circuit stimulation remains on.

[0201] As users evaluate different montages to determine which montages may provide improved recruitment, large variations in stimulus “strength” may hinder comparison of alternative candidate stimulus montages, although differences between adjacent montages must also be made noticeable. In one embodiment, a set of weighting coefficients for a set of stimulation montages (e.g., 5, 7, 9, 11) is selected that both allow the user to distinguish between the different montages (i.e., transitions between alternative stimulation paths that are subjectively perceived as field movement) without undesirable changes such as large changes in perceived stimulation intensity associated with changes in field geometry. Weighting values ​​can also be used to avoid these subjective jumps in sensation for other changes in stimulation montages such as anode-cathode designation, pulse width, etc.

[0202] In an embodiment, adjusting adjacent non-primary stimulation channels (and non-adjacent non-primary channels in the range of 50-75%) by weighting their output currents with a value other than zero, e.g., in the range of 75-90%, allows the intensities of adjacent stimulation montages to remain in an intensity range that causes subjects to report the change in field geometry as a "smooth transition." This strategy has also been found to provide smooth transitions between montages when the stimulation matrix is ​​applied to a user's leg or arm.

[0203] Factors that affect perceived intensity Changes between perceived levels of stimulation intensity may not change proportionally with intensity. Excessive jumps in perceived intensity (i.e., much higher than small differences in intensity changes) may be due to nonlinear strength / intensity recruitment characteristics of cells under individual stimulation channels. Selected stimulation intensities above a certain threshold may be felt as moderate, strong, or very strong. Another factor is vector stimulation from adjacent stimulation pads, which can cause the perceived intensity to be affected by simultaneous stimulation on other pads. Regardless of the underlying cause of the user's sudden changes in intensity, it is desirable to avoid these undesirable transitions. In embodiments, features of the invention allow for the reduction of undesirable perceptual jumps due to these factors, with the goal being to provide benefits such as a smoother perception of transitions between different field geometries, for example allowing a user to more easily compare different stimulus montages.

[0204] An embodiment of SaphLevel In addition to the benefits gained when comparing different stimulation field geometries, incorporating weighted stimulation fields during therapeutic stimulation can also provide advantages. In embodiments, SaphLevel uses a montage of selected non-zero weights on selected non-primary channels to provide improved comfort, increased neural recruitment, preferred stimulation sensations, etc.

[0205] The inventors have discovered that some users prefer to simultaneously stimulate at least one non-primary stimulation channel at a lower intensity than that provided by the primary stimulation circuit. For example, when the first stimulation circuit (e.g., C1-A1) provides stimulation, two non-primary stimulation circuits (e.g., C2-A2 and C3-A3) provide less active, lower stimulation instead. As previously disclosed, benefits were seen in some subjects who reported that the stimulation felt "fuller," "deeper," or "more comfortable." Another advantage of providing low-weighted stimulation at adjacent stimulation pads is that it allows nerve recruitment to occur at a lower maximum stimulation amplitude than required in the primary circuit, thus reducing the likelihood that the stimulation signal in the primary channel will approach or exceed the pain threshold. Without being bound by theory, this advantage may occur due to vector summation of the stimulation field at the nerve location or due to recruitment of multiple branches of a target nerve, such as the SAFN.

[0206] In an embodiment, the weighting values ​​of the non-primary channels are set to change as the signal strength of the primary stimulation channel (weight 100%) increases. For example, a "center" montage may use weights of 80%, 100%, 80% for the initial intensity range, but the weights are changed to 60%, 100%, 60% (usually the higher ranges). This functionality is achieved by setting the channel weights based on a lookup table with row weights corresponding to the defined intensity ranges and the channels defined in each column, or by a simple algorithm using a series of "if / then" rules.

[0207] In an embodiment, after a preferred stimulation field setting is selected using the SaphLocate function, the SaphLevel function is used to provide therapeutic stimulation in a montage different from the montage selected by the user using the SaphLocate function.

[0208] Although many SaphLevel settings use non-primary channel stimulation, stimulation may be provided only from the primary stimulation channel (e.g., non-primary channel weights are set to zero). This provides a more focused stimulation field and reduces the risk of stimulation causing unwanted muscle activation or spasms. Alternatively, the SaphLevel algorithm only incidentally sets non-primary or non-adjacent channels to zero. For example, the system may query the user about calf muscle stimulation through the user interface module 48. If the user indicates that muscle activation is present, SaphLevel will decrease the weighting values ​​of the non-primary channels, or at least the channels closest to the calf muscle. In one embodiment, the SaphLevel algorithm uses information about whether the stimulation matrix is ​​being applied to the left or right leg (e.g., input by a user) to lower the weighting values ​​of non-primary stimulation channels located near the calf muscles compared to non-primary stimulation channels on the opposite side of the matrix. If the stimulation matrix is ​​applied to the left leg, the right side of the stimulation matrix is ​​closer to the calf muscles, whereas on the right leg the pads on the left side of the matrix are closer.

[0209] In one embodiment, the SaphLevel feature sets the channel weights of non-primary channel pads adjacent to the primary stimulation channel to a lower value than the primary channel. This stimulation protocol may reduce the discomfort and pain reported by some users and allow users to tolerate higher intensity levels. If a higher stimulation amplitude can be provided by the primary stimulation channel and tolerated by the subject (perhaps due to phenomena such as sensory gating and lateral inhibition), this increased stimulation signal strength may a) increase modulation of the target nerve; b) increase the likelihood of successful neuromodulation of the target; c) increase the strength of the signal centrally relayed from one or more branches of the SAFN; and d) increase the phase coherence of the average evoked neural response. The use of increased stimulation amplitude may increase the size of the evoked signal delivered to the brain, a factor that may contribute to an increase in the "electrical dose", which may allow for a reduction in total stimulation time, a decrease in the percentage of users who do not experience treatment success, or a corresponding increase in treatment efficacy and patient compliance.

[0210] The perception of the stimulation signal may be affected by simultaneous stimulation (at the same or different intensity levels) provided at multiple locations. Without being bound by theory, the increase in perceptual "richness" from a larger stimulation field, adjusted according to selected weighting factors, may be caused by several factors, including stimulation of additional nerve fibers, gating, and lateral inhibition. These may affect the user's perception, including modulation of pain sensation and paresthesia. A real-world example of these physiological phenomena is when a user applies pressure, rubs, or scratches a spot on the arm near the site of pain to relieve such sensations (e.g., scratching a mosquito bite). The gate control and lateral inhibition models provide a basis for explaining how non-painful stimuli can provide sensory input that interferes with (and / or functionally reduces) painful sensations. Painful nociceptive stimuli stimulate primary afferent fibers, which send signals to the brain via transmitter cells. An increase in transmitter cell activity corresponds to an increase in perceived pain. Conversely, a decrease in transmitter cell activity reduces subjectively perceived pain. Gate control theory suggests that when inputs to transmitter cells that relay signals to the brain are blocked or "gated," a closed "gate" occurs, resulting in a reduced level of pain sensation. This may provide a physiological basis for the observed effects on pain perception, reconciling specificity theory with pattern theory, and incorporating interactions between small (unmyelinated) and large (myelinated) fibers.

[0211] In the gate control model, non-nociceptive fast (myelinated) fibers can block nociceptive slow (unmyelinated) fibers: "fast blocks slow." This theory claims that activation of nerves that do not transmit pain signals, called non-nociceptive fibers, interferes with signals from pain fibers, thereby inhibiting pain. When both small diameter (pain-transmitting) and large diameter (touch, pressure, vibration-transmitting) afferent nerve fibers transmit information to the brain, less pain is perceived (due to reduced transmitter cell activity in the spinal column) when the neurotransmitter activity of the large diameter fibers overrides the upward transmission of signals from the small diameter (pain-transmitting) fibers. Thus, adding as little as 10% or up to 100% of the stimulation provided in the primary stimulation channel and using weighting in the non-primary channels can affect the overall sensation of the stimulation and potentially reduce the pain that the user would otherwise feel for the selected stimulation amplitude.

[0212] In one embodiment, the primary stimulation channel (e.g., center pad C2-A2) serves to provide the greatest source of modulation of the target nerve while stimulation provided by selected non-primary or adjacent stimulation pads provides an auxiliary signal that a) interferes with, b) diverts from, c) competes with, or d) alters the processing of the sensory signal that causes the user to perceive the therapeutic stimulation provided by the primary channel, and the auxiliary signal can enhance or alter the perception of the primary stimulation signal.

[0213] In an embodiment, the "auxiliary signal" is designed to function as a "sensation mask" that masks the sensations generated by the signal delivered by the primary stimulation channel. This specification has typically disclosed the signal provided in the non-primary stimulation channel as the same signal provided as the stimulation signal, albeit at a lower intensity. In another embodiment, the non-primary stimulation pad provides an auxiliary signal that is different from the stimulation signal provided for targeted neuromodulation. For example, the auxiliary signal may have different frequency or waveform characteristics than the therapeutic stimulation signal. The auxiliary signal may be designed to alter the user's perception of the therapeutic stimulation signal. The masking signal may be a low intensity, high frequency carrier signal and may be provided with pads positioned to stimulate primarily the superficial layers of the skin to simply generate competing sensory input. In embodiments, the sensory mask is provided by a non-electrical modality such as vibration, sound, pressure, magnetic energy, or heat / cold. The sensory mask may be constant or modulated at a selected rate.

[0214] In another embodiment, two or more signals are applied from channels of a stimulation matrix, and their combination (vector summation) at the target nerve produces a desired stimulation waveform, while the sensory experience of the stimulation waveform is designed to be improved compared to that produced using the same stimulation waveform by itself in all channels. In other words, adjusting the stimulation montage of the stimulation matrix by activating different arrangements of active channels, or the signals provided by those channels, to control field steering may incorporate principles and strategies related to the summation of stimulation signals (and may be intended to produce beats or other frequencies at the target).

[0215] Considerations and benefits of selected stimulus matrix design. An alternative to a stimulation matrix with a triangular pad arrangement is a 4-pad "plus" arrangement shown in the top half of Figure 7a. A further embodiment uses two sets of 4 pad arrangements for a total of 8 pads. The plus arrangement offers the advantage of long or short channel separation (e.g. C4-A4 and C2-A2) and a wider range of longitudinally displaced / oriented fields while using only two additional stimulation channels. A matrix with preferably 4-10, more preferably 6-8, and most preferably 6 stimulation pads fixedly arranged can allow for powerful stimulation of the SAFN.

[0216] SaphLocate method with sensory criteria Providing stimulation in a limited set of stimulation montages can greatly improve the user's ability to obtain potent stimulation of the target nerve. When using a matrix to stimulate a nerve traveling along the user's limb, adjustment of only one axis may be necessary. Limiting the number of selectable stimulation montages to a set containing 5-10 montages can make adjustments to the stimulation protocol more manageable. Defining a set of stimulation montages that adjust position along a single axis, such as left-right access of a stimulation pad, further simplifies the user's selection of a stimulation protocol. Weighting of the channels in the matrix allows for the selection of different stimulation montages while meeting criteria such as sensory criteria, which include providing a set of adjustments that occur without perceptual jumps in stimulation intensity.

[0217] 8a illustrates a method for providing a stimulation protocol assessment before or during stimulation treatment. In step 100, one or more stimulation signals for a set of N channels are created or selected. When stimulating the SAFN for the treatment of OAB, a 20 Hz stimulation signal with a biphasic square wave may be the default signal provided on all channels. Step 102 involves establishing a limited set of stimulus montages (i.e., channel assignments, weights, etc.) that the user can select or evaluate. The weights of the stimulus montages are adjusted to meet sensory criteria, such as ensuring that the perceived intensity of stimulation is approximately the same when the user adjusts the position of the stimulus field using the stimulus field adjustment controls. The set of stimulus montages is selected to provide an orderly transition in the characteristics of the stimulus field, such as changing the region of maximum stimulation amplitude along at least one axis of the stimulus matrix, such as from the left to the right side of the matrix or from the bottom to the top of the matrix. Step 104 includes establishing a montage series, which includes a set of montages presented in a defined order. Step 106 includes providing stimuli, obtaining user input using stimulus controls, and responsively adjusting the montage according to adjustment rules. For example, if the user selects the left or right control of the directional control, the montage is adjusted by incrementing or decrementing the montage according to a defined series that provides a movement of the field's position from the left side to the right side of the stimulus matrix. Stimulus controls may also be defined to adjust characteristics of the stimulus field in a predetermined manner, including the spread or attenuation of the stimulus field. In an embodiment, the defined shape of the stimulus field is adjusted to move across the stimulus matrix in a left to right or up and down direction. In step 108, user data is obtained, such as a user indicating a preference for one or more stimulation montages and obtaining sensory data that is evaluated to determine whether neural recruitment has occurred. In step 110, therapeutic stimulation is provided to the user based on one or more stimulation montages selected by the user. In one embodiment, the stimulation montage selected by the user is used to provide the therapeutic stimulation. Alternatively, the weights of the selected montage are adjusted (e.g., weights of non-primary channels are reduced) and stimulation is then provided to the user during the treatment. If multiple stimulation montages are selected by the user during the evaluation procedure rather than the treatment, stimulation may alternate between two or more stimulation montages during the delivery of the treatment according to the parameters of the stimulation protocol (e.g., therapeutic stimulation alternates between two stimulation montages at 5 minute intervals).

[0218] Protected Stimulus Configuration In embodiments, the stimulation pads can be configured with anodes that are set to abut the cathode channels laterally, vertically, or both to surround and "protect" the cathode field. This may allow for a stronger signal to be used at the cathode while controlling the spread of the electric field in the direction in which the anode is placed. An example of anode protection is shown in FIG. 7b, where cathode C4 is adjacent to anodes A1, A3, A4, or in FIG. 7c, where the cathode is protected by a set of anodes (A1, A3, A4, and A5). In this way, longitudinal (along the longitudinal axis / length of the stimulation pad) or transverse (along the transverse axis / width of the stimulation pad) stimulation can be "guarded" in an adjustable or selective manner to reduce the risk of activation of the calf or other muscles. "Guarding" the cathode also allows current to be driven deeper into the tissue. Guarding can improve recruitment of the target nerve by suppressing the stimulation field, driving it further below the surface of the skin, and selectively avoiding unwanted stimulation of nearby tissues such as the calf muscles (e.g., soleus and gastrocnemius), biceps brachii, brachioradialis, and coracobrachialis if the target nerve is in the arm.

[0219] Field steering: shape generation, offset, depth adjustment. In an embodiment, the field steering controls of system 10a provide adjustments to: the geometry of the delivered stimulation (e.g., the pattern of active channels); the position of the geometry (e.g., select a different subset of channels to change the position of the stimulation pattern proximal-distal, medial-lateral, or anterior-posterior); the shape of the stimulation field below the skin surface; and the depth of field (e.g., use features such as anode protection, high frequency carrier waveforms, long duration pulses, or adjust the distance between activated stimulation pads, as greater distances may provide a deeper field). In an embodiment, the system's user interface module 48 allows the user to independently adjust the shaping of the field, with user controls relating to adjustment of stimulation field geometry, offset, depth, and protection parameters. For example, user adjustment of field characteristics is accomplished by making pre-specified adjustments to a stimulation montage or by selecting a series of stimulation montages organized to provide the desired adjustments. When used for stimulation of the saphenous or posterior tibial nerves, the "depth" of the field can be adjusted to drive the field deeper, improving neural targeting while avoiding undesired modulation of collateral tissues.

[0220] The app 21 has screens that provide virtual controls including replicas of stimulation controls such as amplitude and stimulation position controls (e.g., virtual controls in Figs. 10c and 10d) or treatment (Fig. 9d) provided on the housing or display of the device 12. The app 21 may have additional screens with controls for adjusting the stimulation field (e.g., Fig. 5g).

[0221] In one embodiment, a first set of stimulation controls can adjust stimulation parameters related to the geometry and location of the field, primarily allowing for the formation and movement of the field across various regions of the skin beneath the stimulation matrix. A second set of stimulation controls allows for adjustment of the field "depth" (e.g., using parameters related to anode protection, pulse duration, carrier frequency, or selecting circuits with smaller or larger spacing between pads). A graphical display can show the shape of the modeled stimulation field, including the calculated location of the maximum amplitude of the stimulation field relative to the rest of the field. Visualization of the calculated depth of field may rely on numerical values, color displays, or 3D graphs. When the user adjusts the "depth" control, the graphic depth indicator or numerical display reflects the adjustment to the stimulation field. This may involve a change in the stimulation montage (e.g., stimulation pads placed further apart are activated to provide a deeper path of stimulation, such as using C2-A2 instead of C-A4 in FIG. 7b). Alternatively, the field depth and geometry may be represented in a 3D grid that the user can rotate, or by using a combination of shape and depth displays, or by other display embodiments that allow the user to view and / or adjust (via a touch screen) the shape, position, and modeled depth of the stimulation field relative to the skin surface.

[0222] In one embodiment, the user interface enables field steering using a representation of the stimulation field on a touch-sensitive screen of the smartphone user device 20a. As shown in FIG. 5i, a graphic shape such as a point, circle, or geometric shape is presented at a position corresponding to the field maximum or the geometric center of the field. The shape or maximum is adjusted by the user "dragging" an area of ​​the image with a finger. The user makes a gesture to adjust the center point (centroid) of the stimulation field, which can be overlaid on a display with a background image, such as an anatomical representation of a leg or an image of a stimulation matrix. A virtual field representation is overlaid on the image with the corresponding location and distribution. Additionally, a user gesture such as pinching the field shape displayed on the screen (e.g., "squeezing" the stimulation field shape between thumb and index finger) serves to narrow the field or adjust its depth (e.g., using anode protection) according to an adjustment algorithm programmed into the user interface module 48 and corresponding to the indicated adjustment. Alternatively, the user interface module 48 may present a display including a "shield" icon. Establishing or moving the shield on the screen biases the field away from the shielded location, limiting the stimulation field from undesired areas (e.g., by adjusting the corresponding anode protection characteristic of the stimulation montage).

[0223] In one embodiment, the field steering or other stimulation characteristics are determined based on the user's physical attributes (see step 108 in FIG. 8b) that may be obtained as part of patient onboarding by a user survey or medical data that may be available to the user. For example, the stimulation regimen characteristics (location, field steering parameter value, or waveform) or parameter value ranges are adjusted based on information from physical attributes such as body mass index (BMI), calf circumference, presence or absence of edema, and measurements of edema severity, imaging data such as nerve location, subcutaneous fat / tissue characteristics, and measured tissue impedance. The physical attributes are input into a model or algorithm that selects or adjusts the stimulation regimen to improve neural recruitment. For example, a patient with edema or a higher BMI may gain more neural recruitment from a regimen that drives the field deeper into the tissue away from the skin surface (e.g., by anode protection or stimulation waveforms that incorporate radio frequency energy for improved transmission or other benefits).

[0224] The system 10a can use predictive analytics, AI, ranking algorithms, and machine learning to analyze and tailor treatment according to data for one or more subjects. These types of analytics can be used to predict treatment outcomes based on user data, determine which users should see a urologist due to lack of symptomatic improvement, and determine which users can provide treatment independently at home or should be supervised by remote medical assistance (i.e., higher level interaction) to discourage non-adherence or dropout. Changes in user data over time can serve as cues that intervention is needed. For example, if a user's rating of satisfaction with treatment is below a value (e.g., 7 on a 1-10 scale), it may be found that referring the user to a telemedicine session reduces the risk of dropping out of treatment.

[0225] The system can use artificial intelligence, machine learning, or other rules-based algorithms to correlate the success of various stimulation parameter settings to outcomes across a population of users. Based on sensory data, measurements taken by the user, or answers provided during survey time, the system can recommend particular stimulation montages or other system characteristics that are likely to be most effective for the individual user. In an embodiment that serves as a simple example, the system may first ask the user about the presence / severity of edema, and the type "pitting" or "non-pitting." If the patient exhibits pitting edema, the system may suggest applying light pressure to the stimulation pads, while in the case of non-pitting edema, radio frequency energy or interferential stimulation strategies may be suggested or used to increase the depth of delivery of energy through the tissue.

[0226] Additionally, the waveform may be selected to provide a sensation that the user prefers (e.g., a lower sensation of stimulation or pain at the stimulation site). If the user has a high sensitivity to skin stimulation at the stimulation site, a higher frequency energy or other waveform characteristics may be selected to improve the user's comfort. Alternatively, a matrix with larger stimulation pads may be selected to increase comfort and reduce current density in the skin area near the pads. Additionally, if the user does not prefer the sensation of stimulation-induced paresthesia, a different waveform that reduces or alters the paresthesia may be used or a masked stimulation may be provided.

[0227] Impedance Measurement Current-controlled systems typically mitigate most problems related to impedance differences. Current-controlled stimulation compensates for the impedance of individual channels, but problems such as inappropriate stimulation can occur if the differences between channels are too large or if one or more channels in the stimulation matrix have low impedance. Impedance monitoring may also play an important role when using ganged or constant-voltage stimulation protocols. The EM module 46 manages device operation by monitoring the impedance sensed by the sensing module 44 and acting according to "improper impedance" rules if the impedance measurements do not meet the impedance criteria. The defined actions can include, for example, setting a flag in the control module 40 to pause stimulation and / or providing a user warning (by controlling the stimulation module 42 and / or the user interface module 48).

[0228] In one embodiment, the EM module 46 is configured with impedance assessment circuitry and software routines configured to allow for proper stimulation and / or field steering using the stimulation matrix. In the case of constant current stimulation, the compliance voltage of the stimulation provided at the higher impedance stimulation pads within the acceptable range can be adjusted based on the impedance changes that occur during treatment. However, if the difference in impedance of one or more pads relative to other pads exceeds a threshold, the actual stimulation field may deviate from the intended field and the stimulation circuitry of the device will not be able to compensate. Even when two stimulation pads are used, it may be difficult to determine which of the two pads is suffering from low impedance. In an embodiment, to detect impedance problems, the EM module 46 is configured to test a set of stimulation pads according to a sequence defined in a lookup table. For example, for a set of three active pads, the circuit can sequentially test defined pair combinations such as pad 1 vs. pad 3, pad 2 vs. pad 3, and pad 1 vs. pad 2. If the impedance of the circuit created by pad 1 and pad 3 is within the acceptable range, pad 2 is indicated to be the problem. Impedance can also be evaluated for pad combinations containing more than two pads, where pad 1 is evaluated against a set of two or more pads, pad 2 and pad 3 in this example. If six stimulation pads are used, the average impedance of five pads can be compared to the impedance of the sixth pad using a criterion that sets a limit of difference based on a value such as 1-10 kOhm or based on a percentage such as +150% (i.e., the difference between the tested channels of a set stimulation pads can be greater than 1-10 kOhm or greater than 150% of the impedance measured in the other circuit). In one embodiment, if six pads are used, testing can be based on sequential combinations of two pads (e.g., two of the three pads in the upper or lower triangle, or each of the three vertical circuits defined for the left, center, and right circuits). In the evaluation method, a circuit of at least two pads must fail an impedance test before action occurs (e.g., alerting the user, evaluation and use of an alternative "substitute" stimulation pad, etc.). Based on this evaluation, if the impedance test performed by the EM module 46 does not meet the defined impedance criteria, the system provides an action defined in the EM module 46, such as a) operating the user interface 48 module to provide an indication of the problem to the user, b) selecting and activating an alternative stimulation pad, or c) setting the pad to an inactive state. For example, the neurostimulator 12 or user device 20 may be used to provide a warning to the user via one or more transducers of the EM module 46, such as a flashing light (or switching the color of a diode from green to red), a vibration, or a tone. A text message or graphical depiction of the matrix on the user's leg is also presented along with color-coded impedance values ​​that indicate to the user the status of the different pads 16 of the matrix 14. The text message (or push notification) can inform the user that an area of ​​the matrix (such as the upper right corner) has high impedance or instruct the user to "check contact with the pad in the upper right corner of the matrix." Impedance assessments may occur at the beginning of a treatment session prior to treatment delivery, during treatment delivery, and / or periodically (e.g., every 5 minutes). Impedance measurements may include short periods of non-stimulation "rest" periods defined as part of the stimulation protocol, or pauses of up to several minutes in stimulation therapy. Impedance measurements may be done in a statistical manner that averages a large number of measurements over a selected interval, or may require impedance measurements to exceed a selected level for a minimum period of time before being rated "unacceptable." If the impedance is unacceptable, periodic auditory warnings that increase in volume over time can be provided to discourage the user from ignoring the warning. The control module can pause therapy if the impedance measurement does not decrease after a selected number of warning signals (e.g., beeps) have been presented to the user. Additionally, stimulation can automatically cease if the impedance exceeds a selected level.

[0229] In one embodiment, when a single cathode "C1" is used with three ganged anodes (A2, A3, and A4), the system first determines whether any channels have inadequate impedance by testing C1 sequentially against each anode before providing ganged stimulation.

[0230] Impedance matching can be useful in ganged embodiments. For example, a first ganged embodiment is achieved by electrically coupling the top three stimulation pads and separately the bottom three stimulation pads such that all three top electrodes function as cathodes and all three bottom electrodes function as anodes to form a single stimulation circuit. Current does not flow equally between the three stimulation pads of each set, but rather is a function of at least a) the impedance of the skin and deep tissue along the path between the electrodes, and b) the placement of the pad / electrode spacing. The amount of current flowing between two stimulation pads can be regulated (i.e., reduced) by stimulation subsystem circuitry (e.g., in a voltage control system) that can introduce additional resistance between a particular stimulation pad and one or more channels of the stimulation generator. Other methods of impedance matching for ganged stimulation designs can also be used.

[0231] In one embodiment, a voltage-controlled ganged stimulation protocol, such as a single pad (e.g., C2) in the bottom half of the matrix referenced to two stimulation pads (A1 and A3) in the top half of the matrix, may result in unequal current flow in the top pad. The impedance between the two circuits (e.g., C2-A1 and C2-A3) can be measured and compensated for. In one embodiment, a set of resistors that vary over a selected range are dynamically included in the circuit to allow for approximately similar current flow along the two paths to enhance field bank uniformity.

[0232] In some voltage control embodiments, the system senses the impedance across circuits defined for different combinations of stimulator pads. The impedance measurements are used to create modeled fields that are represented in a heatmap display. For example, where impedance is high, less current will flow between two or more of a set of stimulator pads, and current flow is modeled more strongly across adjacent channels with lower impedance. The modeled stimulation field can include model parameter values ​​related to signal amplitude, electrode shape, size, and placement (inter-pad distance, and orientation) of pads within the matrix (i.e., "matrix pad geometry"). Modeling can also incorporate sensed impedance measured between different pairs of stimulation pads to set values ​​for tissue resistance or skin-hydrogel interface impedance.

[0233] Adjustment of stimulus signals and montage characteristics and user surveys. Various factors, such as the pandemic, may make telemedicine preferable over an in-person doctor's visit. The system 10a is designed to allow the patient to accomplish the setup by working independently or under the guidance of a medical professional. In either case, the digital ecosystem module 50 manages the user training on the stimulation 104 during onboarding. As the user adjusts and selects the desired stimulation field settings, such as geometry, location, and intensity, the system obtains user input responses regarding the stimulation-evoked sensations.

[0234] In one embodiment, during training or treatment, the system surveys the user to describe sensations associated with neural recruitment by providing options such as "tingling, vibrating, tickling, tapping, pinching, biting, other." Survey items may also relate to perceived intensity or comfort, with options such as "mild, moderate, strong, uncomfortable, painful, intolerable." Scale attributes such as "mild tingling," "moderate tingling," and "strong tingling" may be combined. Additionally, the defined training protocol may concomitantly prompt the user 106 to increase stimulation intensity if the user input indicates insufficient sensation, e.g., only "mild tingling." The training program may incidentally display a message asking the user to use a different setting, such as "A moderate or strong tingling radiating up and down the leg may be more effective. Would you like to increase the intensity?" 106. If the user accepts the proposed option, the user is provided with a user display having controls that allow the option to be implemented, i.e., at least a control to adjust the intensity. If the user rejects the option, the program simply proceeds to the next step of completing the training. If the system is designed to stimulate neural targets in the human arm, the software settings and labels are adjusted to be appropriate for the arm rather than the leg. For example, when surveying a user for paresthesia, survey items are anatomically appropriate. "Extending to the fingertips" is used rather than "to the toes". Similarly, a survey about paresthesia that "moves toward the knee" is replaced with the option "moves toward the shoulder".

[0235] A SaphLevel or SaphLocate feature incorporated into the training or treatment delivery can explore the location of paresthesia associated with a selected intensity or stimulation field geometry. Options include, for example, "directly under the stimulation pad," "above the pad toward the knee," "below the pad toward the ankle," "up to the ankle," "mid-foot," and "all the way to the toes." Alternatively, a map of a body part, such as the leg (or lower leg, from the knee to the foot), is displayed and the user is instructed to tap on a graphical display to indicate one or more areas associated with paresthesia (e.g., the nadir where paresthesia is felt). An "X" is then plotted at that spot (see FIG. 9e) and the user is asked to confirm. If the user indicates that stimulation is only felt "directly under the pad," the system can concomitantly prompt the user to further adjust the intensity or montage characteristics, such as generating paresthesia that radiates from a location under the pad.

[0236] In an embodiment, during training 104, the user is specifically asked about the presence of calf or other muscle irritation. The survey may ask about leg movement and the presence or absence of cramps. If the user confirms this undesirable side effect a defined number of times during onboarding or treatment, the system may concomitantly act 106 to schedule or prompt the user to schedule a virtual meeting with a medical professional. Another concomitant act 106 includes setting a flag value for this parameter in the log or patient profile. Alternatively, the system may concomitantly act 106 to prompt the user to select a different montage or present the user with an "advanced" screen of the control unit (e.g., FIG. 5j) that allows or allows a more detailed set of field steering controls to be utilized, enabling anode protection or field shape generation controls that guide the user to adjust the field shape, position, or direction away from undesirable positions to avoid undesirable side effects. In addition to allowing or guiding the user to reduce stimulation to the muscles using these adjustments, the system also allows for adjustments of the stimulation signal, for example, the default pulse train stimulation waveform can be replaced with alternatives such as burst stimulation, interferometric stimulation signals, or high frequency carriers (e.g., 500Hz-100kHz) that are either unmodulated or modulated with an envelope of nominal frequency (e.g., 1-100Hz) and pulse width (e.g., 10μs-1msec).

[0237] Curated Neurostimulation Programs: Onboarding. In an embodiment, the onboarding process guides the user through the first use of the system 10a. Shorter onboarding sequences can also be defined at the beginning of each treatment session. The NiNA ecosystem provides a curated user onboarding process that includes functions such as providing an overview of the treatment, training the user on providing stimuli, surveying the user to develop a user profile and set user preferences, and providing educational content. The user is provided with instructions on a series of topics, asked to perform operations and activities, and may also be surveyed where the user's responses are recorded. Onboarding may include instructing (or asking) the user about which leg to use during a treatment session, instructing the user to adjust stimulation, location, and intensity characteristics and surveying the user about perceived sensations (for at least one intensity or montage selected from the suggestions), asking the user to illustrate information using images, and prompting the user to provide or confirm information by acquiring image data, such as taking a photo of the device on the foot to track device placement. This process may occur primarily using visually presented information upon user interaction with the smartphone 20a, or may incorporate interaction with virtual assistant technology, such as an Amazon Echo device 20e, which provides instructions and captures, processes, and stores the user's voice-based responses. The onboarding operations may also be supplemented by image data acquired using an image capture device (of a phone or webcam) that provides the data to a software engine that can identify user behavior through image analysis to automatically identify user activity, such as determining which leg the wearable is attached to (and the placement of the device on the leg). Information obtained through visual and audio interactions with one or more system devices may then be logged and uploaded to a remote computer 20f or user device app 21. Onboarding may use screens such as those shown in Figures 10a-10k.

[0238] FIG. 10a shows a screen 258 for providing the functionality to educate the user and provide an overview of the treatment process. FIG. 10b shows a screen 260 that provides the ability to train the user 104 on properly fastening the wrap to the leg and adjusting properties that may be related to position and pressure.

[0239] FIG 10c shows a screen 262 for providing functionality related to training the user 104 on how to adjust stimulation intensity, and FIG 10e shows a screen for providing functionality related to training the user on how to adjust the location of the stimulation field. Either of these steps may include or be followed by surveying the user on the quality, intensity and location of sensations, including paresthesia, as seen in screens 264 and 266 depicted in FIG 10d and FIG 10e. The user may be asked to provide a score or ranking of characteristics related to neural recruitment or undesirable side effects. If neural recruitment is not achieved or undesirable side effects are present, concomitant actions may occur, such as NiNA instructing the user to move wrap position, change pressure, repeat steps to adjust intensity and position, or change other stimulation characteristics until stimulation is successful. In embodiments, the NiNA functionality is designed to educate, probe, and train the user on SAFN stimulation along curated sequences that guide the user through treatment-related maneuvers including achieving successful stimulation. As seen in FIG. 10e, after stimulation adjustment, the user is asked to indicate one or more areas where stimulation-induced paresthesia is being experienced by manually adjusting an "x" to the corresponding location on the image. The user can be surveyed to indicate the most proximal or distal location (or both) where paresthesia is sensed. This information can be ranked, organized, and displayed to assist NiNA and / or the user in determining settings where neural recruitment was successful.

[0240] In an embodiment, the digital ecosystem module 50 includes software in its virtual module 50a that enables a user to select (e.g., draw) one or more regions of an anatomical representation of a body part of the user, such as a leg, to indicate a location that corresponds to where the user feels a stimulus-induced sensation, such as paresthesia. The user may also be surveyed for the quality of sensations associated with the stimulation (e.g., vibration, tickle, pressure, etc.). The user may also be surveyed to determine whether any undesirable side effects have occurred. If, using anatomical maps or other methods, the user indicates that an undesirable area or type of stimulation has occurred (e.g., stimulation of the calf muscles), a defined contingent action occurs. For example, the algorithms of the control module 40 select or suggest alternative stimulation settings that may provide improved comfort or inform the user that muscle co-activation should be avoided, such as a set of one or more montages that provide low weighting near non-target areas (e.g., shin muscles or calf muscles) or have a geometry that provides no stimulation.

[0241] NiNA can also provide a curated sequence of alternative stimulation protocols (and associated matrix settings that result in different patterns of stimulation pad activation) that are cycled through the system. The program cycles through the candidates to determine which ones produced the greatest or most distal areas of paresthesia (e.g., tingling in the toes) and / or undesired side effects. Rather than simply experiencing the various stimulation montages, the user may be surveyed to indicate, by button press or verbal input, which of the sequence of stimulation settings did not produce the undesired effects. The sensed information relating to at least one of the SNAP and EMG data may also be used to evaluate to generate a score or ranking that is used to adjust the stimulation montage. Successful settings may be saved and further evaluated by the user or selected during treatment. Also, protocols that result in calf or other muscle activation above a defined level may be excluded from further evaluation.

[0242] In an embodiment, the user can rank each stimulation montage according to the amount of neural recruitment and one or more side effects. The montage with the highest ranking of neural recruitment and / or the lowest score of side effects is stored in a look-up table. Thus, if a series of protocols does not cause undesirable side effects and one of them produces the strongest ranking of neural recruitment, this protocol can be suggested to the user or saved for further use during the treatment session. In addition to selecting the location at which the paresthesia is experienced, the user may be asked to provide qualitative, quantitative, or ranked feedback regarding the sensation (e.g., tingling, throbbing, tickling, vibrating, etc.). Data regarding sensory perception and side effects entered by the user as part of the training or evaluation procedure may be used by NiNA to select a set of stimulation protocol characteristics.

[0243] Fig. 10g shows a screen 270 for providing functionality related to setting treatment schedule preferences, and Fig. 10h shows a screen 272 for setting the times at which reminder alerts are provided (which may vary by day). Additional schedules may be displayed to the user and set up for treatment events such as education, user surveys, remote sessions, etc.

[0244] Figure 10f shows screen 268 of NiNA features related to training, education, and coaching. By selecting items on the screen, the user can receive on-demand education on nutrition and dietary choices that can improve symptoms (e.g., screen 274 in Figure 10i), behavioral therapies such as Kegel exercises shown in screen 276 (Figure 10j), and education about the disorder being treated and its symptoms, depicted as screen 278 (Figure 10k).

[0245] In an embodiment, the onboarding process 100 relies on a set of user survey rules created using probabilities determined from a sample of previous users or based on the results of medical literature, demographics, medical history, and logic. The survey rules defined in the survey module 50f collaterally guide the user's responses to an initial set of one or more survey items to later items that are more likely to be relevant to the user. For example, in the treatment of OAB, if the user responds to a first survey item indicating that nocturia is a symptom, the next survey item may inquire whether the subject suffers from restless legs syndrome (RLS) if the subject is 65 years of age or older. This survey item is likely to be more relevant because the risk of RLS increases with age and may contribute to the frequency / risk of nocturia (or may be caused by RLS rather than OAB). In another example, if the user indicates that they do not suffer from stress urinary incontinence, the survey module 50f is modified so that the user is not subsequently asked questions regarding performing exercises that focus on stress urinary incontinence (SUI), or about what activities (e.g., laughing) are likely to cause stress urinary incontinence. In another example, if one or more survey items are answered as "not applicable" by many users who share a particular characteristic, or who also answered a previous set of one or more survey items in a particular way, that survey item may be omitted from questions presented to subsequent users of the system 10a.

[0246] In an embodiment, during the onboarding process controlled by onboarding module 50e, the user is surveyed 108 about treatment goals. For example, the user may be asked to select the most important treatment goal, rank the treatment goals, and rate the importance of goals such as reducing leakage or pad / diaper use, reducing the number or severity of urges to urinate, reducing frequency of nighttime or daytime urination, reducing the dosage of bladder medication required for symptom relief, the ability to delay longer before urination occurs, or reducing anxiety about symptoms. Responses are stored by user profile module 50g, and the treatment program is then modified based on these answers. For example, NiNA adjustments based on answers provided during onboarding can include educational content presented to the user from reference material module 50b, survey items or user answers used to track the user's treatment progress, scores used to evaluate user treatment progress 144 (which can also be used to adjust the treatment program, such as changing the treatment duration, weekly frequency, etc.). Part of progress tracking 144 includes updating and presenting timeline information as treatment continues and as the user completes (or fails to complete) treatment events and activities according to logged data information and according to changes in symptoms.

[0247] Users who wake up in the middle of the night to go to the bathroom (nocturia) may share some common behaviors and characteristics: a) Not reducing alcohol consumption before bed; b) Keeping a glass of water near the bed to drink during the night; c) Drinking coffee, tea, or soda at night; d) Waking up after already wetting the bed and not feeling the need to urinate anymore; e) Waking up and going to the bathroom without leaking; f) Waking up with a strong urge to urinate and often leaking before getting to the bathroom. Alternatively, some OAB sufferers may typically sleep through the night and only experience symptoms during the day. In an embodiment, the onboarding module 50e can survey the user to indicate which of the above behaviors / traits are relevant and will then adjust treatments, surveys, or scheduled ecosystem events according to the user response.

[0248] For example, if the user indicates that nocturia is not a problem in step 100 of FIG. 8b, the system may no longer ask about symptoms related to that problem as part of step 104. If the user does not suffer from nocturia, as part of step 104, the system may also adjust parameters of coaching module 50h when surveying the user about this symptom, or modify progress module 47 to not include nocturia symptoms in tracking or assessing treatment progress when calculating a score used to assess progress. Alternatively, coaching module 50h of digital ecosystem module 50 is adjusted for users who provide positive responses to items a-e as part of step 100. In an embodiment, the coaching module 50h is adapted so that the system can present videos, articles, statistics, or "fun facts" about nocturia as part of step 104 and set push reminders to occur at selected times, such as "don't drink 2 hours before bed." It may also suggest to the user that providing treatment at night may be preferable to providing treatment in the morning. The system 12 may also ask the user additional questions related to the frequency or severity of the symptom or behavior (e.g., how many nights per week or how many times per night the user is woken up by the need to urinate). Educational content tailored to modify the user's specific behavior and educate the user about their individual issues helps improve the overall treatment experience in addition to the benefits gained from neurostimulation.

[0249] In an embodiment, the user is surveyed for stress urinary incontinence at step 100. Users who exhibit symptoms of stress urinary incontinence may be surveyed further as part of the onboarding process or at a later step provided during treatment. If only stress urinary incontinence is identified during onboarding, the user may be informed at step 104 that treatment may not be appropriate as it is primarily aimed at urge or mixed urinary incontinence. As part of step 104, the user may be asked to schedule an in-person or telehealth visit to further discuss this topic with a medical professional. Alternatively, the system may be configured to survey the user with additional items designed to more accurately assess whether the user is suffering from mixed incontinence. In this latter case, the user may be informed that both stimulation and Kegel exercises or bladder drills should be included in the treatment program to properly treat the condition, and both the prompts and education may be scheduled by the coaching module 50h as part of the treatment. Additionally, an indication of mixed incontinence may result in an adjustment to the schedule of the coaching module 50h to provide more frequent remote sessions (or prompts to schedule sessions) with a nursing technician who has access to the patient profile record in which mixed incontinence is noted as an issue to be treated and evaluated during treatment.

[0250] In an embodiment, during onboarding procedures provided by onboarding module 50e, or later by survey module 50f, system 12 surveys the user as to how bothered they are by various symptoms. This may include, for example, a scale relating to how severely the symptoms are affecting the user's lifestyle choices or interfering with their life in other ways. The user's answers regarding bother can be compared to the user's scores on survey items regarding symptom severity. If the symptom severity scores do not correspond to the symptom bother scores, the system may operate concomitantly. For example, the user may be further probed as to why the bother score differs from the severity of the symptoms. The user may be surveyed to determine whether they are bothered by: a) a belief that the symptoms are part of normal aging, b) the user has become accustomed to the symptoms long term, c) the symptoms are becoming less bothersome as the user has adapted / acclimatized to their daily life, etc. If the symptom severity and bother score differ, the system can present selected materials that are tailored based on the user's responses to these survey items. The system 10a can also adjust the progress tracking 114 performed by the progress module so that improvements in bothersomeness scores are tracked and presented to the patient instead of scores directly related to the symptoms. In this way, the user can see progress measured by improvements in how bothersome the symptoms are, even if there is a small change in the severity of the symptoms themselves. Reduction in bothersomeness can also be used as a treatment goal.

[0251] In one embodiment, the survey responses are evaluated to indicate whether the user has a profile that responds well or poorly to stimulation therapy. The system 10a can obtain and evaluate user profile data during onboarding 100 or as part of a website where the user enters data before starting therapy. Data from a population of previous users of the therapy is used to identify subpopulations of users who are likely to benefit or not benefit from stimulation therapy or who may require a longer induction period. For example, the user may be asked about previous or concurrent treatments (e.g., Botox, medications, pelvic floor electrical therapy for stress urinary incontinence, other types of electrical therapy such as Kegels) and symptoms. The user may also be surveyed about previous or current OAB medications (e.g., oxybutynin, tolterodine, darifenacin, fesoterodine, solifenacin, solfenacin, trospium, mirabegron) and dosages. The survey may also include other medications for conditions such as high blood pressure, anxiety, depression, headaches, migraines, pain, etc. Users can also be surveyed for comorbidities such as diabetes, hyperglycemia, hypertension, metabolic, immune, inflammatory, or other disorders. Patient education and treatment can then be modified according to the user profile data. If a particular medication has been shown to increase the risk of worsening OAB symptoms, the user is informed of this risk and can receive additional education. In embodiments, the systems, stimulation protocols, and NiNA support are not designed to treat OAB, but are configured to provide treatment for any of the conditions and co-morbidities disclosed herein, and further, in embodiments, are designed to treat addiction or substance abuse.

[0252] In one embodiment, if the user indicates that they are taking medication to treat OAB or another condition, the ecosystem surveys the user whether they would like the system to provide medication reminders as part of coaching 140 in addition to those provided for the stimulation therapy. Medication reminders can also require user input at the time of medication administration, allowing the system to track compliance with both medication and therapeutic stimulation. If a drug or other therapy is provided in combination with the SAFN stimulation, it can be tracked, compliance assessed, and reminders provided.

[0253] Onboarding and treatment methods. The steps disclosed in Figures 8a, 8b, and 8c, as well as other methods, phases, and programs disclosed herein, may occur as separate steps, be repeated, and incorporate steps shown in other methods. As in Figure 8b, an embodiment of a curated treatment program includes NiNA functionality provided by the digital ecosystem 50 to first onboard a user 100 and then guide the user through treatment 130 to provide a user-friendly neurostimulation treatment experience and improved treatment outcomes.

[0254] In an embodiment, as part of step 100, a mobile software companion application "app" 21 is uploaded to the user device 20a. An onboarding wizard in the app 21, which forms part of the onboarding module 50e, provides a guided / structured sequence of actions to aid in onboarding the user (e.g., Figures 10a-10k). An interactive display allows the user to set preferences that are used by the software program to deliver the treatment. Onboarding welcome operations introduce / explain topics such as medical barriers and provide an overview of therapy and treatment timeline (e.g., Figures 9b, 9c). This includes graphically presenting the user with a timeline of future scheduled therapy events, such as patient surveys, education events, and at least one transition date from induction therapy to maintenance therapy. Onboarding 100 provides instruction and training on how to calibrate and determine neurostimulation therapy, proper device placement, correct amplitude and stimulation montage, and identifies additional capabilities of the NiNA ecosystem.

[0255] In an embodiment, the introduction process 102 includes steps such as: a) operating the app 21 to set up a user account with contact and billing information; b) securely communicating with the neurostimulator 12 to exchange data including device 12 and matrix 14 ID data; and c) communicating all data related to the onboarding process to the user account on the remote computer 20f.

[0256] In an embodiment, onboarding includes providing the patient with an overview of the treatment 102 (e.g., Figures 10a, 10b) and accessing a library of educational content regarding their diseases and symptoms (e.g., Figure 10k), various features available as part of the treatment (e.g., Figure 10d), and how to deliver the treatment in a home setting (e.g., Figures 10c-f). The onboarding introduction 102 may include video content (e.g., setting up and using the device, how to detect and evaluate stimulation-induced sensations or activity, how to adjust, evaluate, and select appropriate stimulation parameters), access to web links, review of reference materials, and / or remote telehealth sessions. After the instructional video is displayed in step 102, concepts are reinforced and the user is given training 104 on aspects of the treatment and is guided through step-by-step screen prompts to attach the device to their body and set up the system for first use. Instructions also include diagrams, animations, and visually presented instructions on topics such as how to adjust stimulation parameters to produce neural recruitment.

[0257] Training 104 may include screens that allow the user to adjust the intensity (e.g., FIG. 10d) and location (e.g., FIG. 10f) of stimulation using the NiNALocat protocol, and may include obtaining user feedback on stimulation-induced sensations (e.g., FIG. 10e). While muscle activity may be an undesirable side effect of SAFN stimulation, for other nerves, successful nerve recruitment may involve reduced induced muscle activity (e.g., using PTN stimulation), or reduced tremor magnitude (e.g., if treatment is provided for tremor or movement disorders), or other procedures related to the treatment of another disorder. In these other treatments, the user is surveyed for both the desired stimulation-induced changes and undesirable side effects.

[0258] For SAFN stimulation, the training step 104 may include instructions and training exercises on: a) an overview showing the user providing stimulation, b) how to properly position the matrix on the leg (e.g., FIG. 10c) and adjust the stimulation strength (e.g., FIG. 10d) and position / geometry (e.g., FIG. 10f) of the stimulation field to target the SAFN and provide sufficient neural recruitment, and c) how to control the electrical stimulation to achieve strong but comfortable paresthesia from SAFN stimulation, asking the user to describe / confirm the paresthesia (e.g., FIG. 10e), and guiding the user until improved neural recruitment is achieved. Control of stimulation protocol parameters during training can also be used to avoid undesirable effects such as a) undesired spread of the electrical field resulting in simultaneous muscle stimulation (e.g., calf, leg, or foot muscles), b) sensation of pain from the skin beneath one or more stimulation pads due to non-SAFN cutaneous nerve recruitment, and c) reducing or avoiding the need to use higher amplitudes to recruit SAFNs. Training step 104 can also include asking the user about their perception of the stimulation, including a) qualitatively characterizing the paresthesia sensation (e.g., tingling, pinching, etc.) and b) quantifying the intensity of the sensation (e.g., light, strong, very strong, etc. in FIG. 10e; or rating the intensity on a scale of 1 to 10 with 10 being "barely tolerable," etc.) and providing information about the location or area of ​​the skin irritation or paresthesia.

[0259] In step 106, contingent actions are defined that occur based on feedback regarding the effectiveness of the stimulation. If the user does not experience sufficient paresthesia during treatment with the SAFN (which may indicate a lack of neural recruitment) or has undesirable symptoms, contingent actions are defined to guide the user to correct the problem so that improved treatment is provided. For example, in step 106, the user may be asked to make adjustments and repeat the process until successfully stimulating the target nerve, may be incidentally provided with further instructions such as changing parameters if undesirable muscle stimulation is occurring, switching to the other leg, changing positioning on the same leg, or initiating a remote session for guidance by a medical professional.106 However, training and feedback to enable correct device use and stimulation parameter setting often needs to be purely programmatically supported. During training, the user may be incidentally guided by responses to survey items when assessing or establishing characteristics of the stimulation protocol related to stimulation amplitude, field steering, etc. For example, the device may survey the user by presenting the question "Do you still feel any stimulation" on a screen, and if the user response is "no," the device may incidentally instruct the user to "Increase the intensity."

[0260] At step 108, the user is surveyed on a variety of topics, including the presence and characteristics (e.g., frequency, timing, and severity) of symptoms. In an embodiment, the user is queried about symptoms to provide information regarding treatment goals, medical and treatment history, and other relevant information. In addition to the symptom survey, the user may be asked to confirm selected educational information based on reported symptoms, medical history, etc. Additionally, all user responses are stored and / or processed to adjust the user profile. The user profile data can then be used to adjust treatment parameters and events. For example, the user's treatment goals can be used to adjust the educational information provided, the measures tracked over time, the symptoms and treatment effects, the survey items presented to assess the progress tracked and the goals achieved. If the primary treatment goal is to reduce pad use, the treatment characteristics selected, such as behavioral training, will be different from those selected if the goal is to reduce nocturia.

[0261] In an embodiment, the onboarding operations include logic tree structures and / or algorithms utilizing rules, artificial intelligence, machine learning, with or without the use of neural networks, and other adaptive strategies to ask questions and adjust treatment to improve a user-friendly experience. For example, if a patient answers survey item 108 and indicates that they have not been previously prescribed an OAB medication, survey listings that require the user to indicate previously used OAB medications are incidentally skipped 110, according to survey logic rules operated by survey module 50f. As another example, if a user indicates during survey 108 that their top reason for seeking treatment is incontinence, subsequent survey items on that topic are conditionally selected 110 to be presented. The survey module of the system may also concomitantly reduce or omit survey items that obtain user input regarding symptoms that the user reports as "not a problem" (e.g., rules may be defined that flag relevant survey items so that they are skipped during treatment). Also, if the survey 104 indicates that a symptom is not present or that a particular symptom has a low "worry score," information about that symptom may not be tracked, displayed, or used to evaluate changes in symptom severity or in patient goal evaluations.

[0262] In one embodiment, a user enters data related to their medical condition using a logic tree menu that allows for easy recording of medically relevant events, including quantification or qualification of at least two relevant characteristics. For example, for a leakage event or bladder emptying event, the system requires the user to enter a combination of two or more characteristics, such as subjective urgency data and leakage volume. The urgency of the leakage event can be initially selected as low, medium, or high urgency using the menu bar. After the user moves his / her finger vertically to select one of the possible options, the user slides his / her finger to the right to select a second characteristic of the event. For example, this action invokes another menu tree that includes a second set of possible choices related to a second characteristic, which in this example is amount. The second set of possible choices might include small, medium, and large. To finish logging the two characteristics of the event, the user can indicate that a selection has been made with a gesture such as a "tap" on the screen. This input method requires the user to characterize the event in at least two (or more) dimensions.

[0263] In step 110, the survey response data is used to create a baseline symptom score. In embodiments, these data are used to concomitantly adjust which symptoms are assessed as treatment continues, when the symptoms are assessed, how these are scored and tracked, how treatment progress is evaluated, and how treatment success is defined. For example, if a user does not report a problem with nocturia, that measurement may not be used to evaluate treatment progress.

[0264] In step 112, the user can provide user preference information for therapy parameters such as therapy events and patient reminder schedules (e.g., Figs. 11a / 11b). Schedules are set for various therapy events including days, times, and durations for providing therapy stimuli, user education, symptom surveys, and other therapy protocol events.

[0265] In step 114, these preferences are used to concomitantly adjust treatment schedule parameter values ​​so that the system prompts the user at the corresponding times and days (eg, days of each week).

[0266] At step 116, the user is surveyed to define the characteristics of the alerts that will be provided according to the user preferences. Alerting the patient may include the use of sounds, push notifications, calendar entries, emails, etc.

[0267] In step 118, the user-provided data and preferences for alerts are used to adjust the alert protocol parameters used by the system to provide a treatment regimen.

[0268] In step 120, the system surveys the user to obtain information regarding skin sensitivity and assess the presence of user characteristics that increase the risk of adverse reactions related to skin "skin events" (e.g., tears, bruising, skin irritation).

[0269] In step 122, the system concomitantly adjusts operational parameters in association with one or more user responses or depending on the composite skin risk score, including providing or instructing the user on user behavior or adjusting a treatment protocol, which may reduce the risk of a treatment-related skin event. Step 122 may lead to the operation defined for step 176 of FIG. 8c.

[0270] In step 124, data obtained from the user onboarding operations is used to create a patient profile and concomitantly tailor associated therapy regimen characteristics 126. This includes tailoring operations in providing various system functions, where these functions occur according to the information and preferences stored in the patient profile.

[0271] "Restore" induction program, "Maintain" maintenance program. The onboarding wizard provides the first step in establishing the system's 10a curated guided treatment "Restore" program. Treatments provided by the system 10a can be guided, non-guided, or a combination. Even when treatment is guided using the Restore program, users can still access reference materials and complete surveys in an unscheduled, on-demand manner.

[0272] If the user indicates that the system 10a is to be used in a non-selective mode, or if the Restore program set of features is configured as non-customizable, during onboarding the user may skip (or not be presented with) adjusting parameter values ​​for features such as the days / times used for patient surveys. Typically, the user is guided through a pre-specified onboarding process 100, which may include actions incidental to user input. Onboarding allows for the creation of a patient profile 124 with the user's data and preferences that are used to adjust the parameters of a curated treatment regimen at scheduled events such as treatment, patient education, and symptom tracking. The Restore induction program is followed by a "Maintain" therapy regimen of maintenance treatment. Curated therapy regimen events are triggered when a pre-determined date and time matches the date and time value of the real-time clock of the control module 40, either by user command, by a remote user device 20f, or by a command received by another component of the system 10a.

[0273] Conventional office-based treatment using percutaneous posterior tibial nerve stimulation (PTNS) typically involves a 12-week induction period of weekly stimulation, followed by a maintenance period of approximately one treatment session per month. Prior to our studies, the interval required to provide sufficient induction with daily transcutaneous SAFN stimulation was unknown. We conducted a clinical trial, the results of which support that a period of 28-35 days is an appropriate induction interval for the treatment of OAB with transcutaneous SAFN stimulation.

[0274] More specifically, in a study of over 50 OAB patients (~50% refractory, ~50% treatment-naïve), daily at-home SAFN stimulation sessions lasting 30 minutes demonstrated improved OAB therapy benefits when intervals of at least 22 days were used, mostly with induction intervals of less than 35 days. Without wishing to be bound by theory, a meta-analysis of several clinical studies recently conducted by the inventors supports that the 28-day Restore program was sufficient for the majority of patients (e.g., 70%). Although some patients showed symptomatic improvement by 2 weeks, using induction intervals of 21 days or less was found to be disadvantageous in the long term. For example, induction intervals as short as 15-21 days are associated with lower treatment success rates and less symptomatic improvement at 90, 180, and 360 days compared to induction intervals of greater than 21 days. It is preferred to define a Restore induction treatment program to last from 22 to 35-42 days, preferably 28-35 days. In embodiments, the 28 days may be concomitantly extended to 35 days, 42 days, etc. if the minimum defined improvement is not obtained by 28 days, or if the patient chooses or allows a 42 day induction period. Extended induction periods are accompanied by additional predefined scheduled events, such as user surveys, coaching events, positive reinforcement messages, goal tracking, etc.

[0275] An example of the benefit of an induction period of 28 to approximately 35 days compared to a shorter induction period of 15 to less than 21 days is shown in Figure 13 (Objective OAB measures: subjective measures over clinically meaningful changes). The table shows a more consistent benefit at 180 and 360 days for the induction group of more than 21 days. Without being bound by theory, these data support for the first time that the daily induction interval of SAFN can be shortened from the 12 weeks used in clinic-based PTN up to 28 days, with good efficacy even after one year of maintenance regimen. Even if the user's symptoms improve immediately, induction periods of less than 21 days seem to result in lower long-term treatment efficacy.

[0276] Although these results were obtained with daily SAFN stimulation, they are important for minimal treatment protocols of other disorders when peripheral stimulation is used to promote neuroplastic changes. This may also be relevant for OAB treatment with other peripheral nerves of the leg, such as PTNS. The proposed schedules for induction and maintenance are applicable to the embodiment.

[0277] In an embodiment, the induction protocol is preferably defined to occur daily for at least 30 minutes. The protocol may employ a minimum of 5 or 6 days to meet compliance criteria. The protocol may allow or require one or more sessions per day (e.g., morning and evening), or may be implemented as two short treatment sessions of 15 minutes each, or may employ longer treatment sessions (e.g., 1 hour). If providing more than 30 minutes of stimulation per day, the Restore program may be shortened to intervals shorter than 28 days.

[0278] In embodiments, the Restore induction can be concomitantly extended at least once over 1-4 weeks 136 if the user does not meet one or more minimum symptom benefit criteria after a certain interval or is willing to extend to increase treatment benefit. A longer induction interval can be set in the patient profile information established during onboarding or selected at the end of a defined induction interval.

[0279] Intervals can be adjusted to employ longer stimulation sessions (e.g., 60-90 min), and multiple daily stimulation sessions (e.g., morning, afternoon, and / or evening) during the original or extended treatment intervals. At the end of the period defined in the Restore program, the user (either because they have not obtained the minimum treatment benefit or for other reasons) may be asked to choose to a) extend the average treatment session time (e.g., from 30 minutes to approximately 45, 60, or 90 minutes); b) increase the number of stimulation sessions per day (e.g., 1, 2, or 3); c) increase both the length and number of treatment sessions beyond the permitted limits; and / or d) increase the induction period to one of several permitted intervals. Alternatively, the guidance protocol may be designed to concomitantly increase the length, number, or both of therapy sessions based on user data.

[0280] In one embodiment, during onboarding, patients can select induction intervals of 28, 35, or 42 days, and treatment intervals of 30 or 60 minutes, delivered over one or more sessions each day. Highly dedicated users can select intervals of 42 days with up to 60 minutes of stimulation each day. Going beyond 60 minutes does not provide any additional efficacy and may increase the risk of skin events.

[0281] For most patients, 60 minutes of intense but comfortable stimulation over 42 days of use appears to be sufficient to achieve adequate therapeutic effects when stimulating the SAFN in the treatment of OAB.

[0282] During maintenance periods, scheduled stimulation, or stimulation provided by the user on demand, can be designed to occur only 1-3 days per week. In one embodiment, a module, such as an onboarding or adherence module, a) Time-based criteria can limit the number of therapy sessions that can be scheduled or offered within a selected time frame, such as a 12-hour period. This type of criteria can also be defined for different calendar days (e.g., a user cannot offer a therapy session on Tuesday at 11pm and Wednesday morning at 7am); b) circadian criteria may limit the amount of stimulation that can be scheduled or provided per calendar day (e.g., 30 minutes); c) interday criteria may limit the amount of stimulation scheduled or provided on different calendar days; d) Within-week criteria may require that the user select or provide stimulation on non-contiguous days with at least one intervening day. Other criteria may require that if the user selects two adjacent days for scheduled stimulation (e.g., Monday and Tuesday), the third scheduled treatment must be non-adjacent and at least 1-2 days apart (e.g., Friday is allowed). and e) a requirement that days in adjacent weeks must be spread out to meet the weekly criteria, such as the weekly criteria not allowing three days to be scheduled or occur within a period of three days within two consecutive weeks. For example, the user would be limited, or at least provided with an advisory message, to scheduling or providing maintenance stimuli according to at least one of several different types of sequential stimulation criteria, such as not allowing a user to schedule or provide stimulation on Monday, Saturday, and Sunday in a first week and Monday, Tuesday, and Wednesday in the next week.

[0283] These criteria discourage users from providing therapeutic stimulation according to a schedule that "packs" stimulation into clusters, rather than distributing the stimulation more evenly in time. In one embodiment, if a user provides stimulation that violates the continuous stimulation criteria, the stimulation session is not counted toward meeting the minimum amount of stimulation in a particular interval. Contingent actions may be triggered as if the therapeutic stimulation had not occurred (e.g., a patient reminder may be provided contingently to meet therapy compliance criteria). Criteria can also be defined to require a certain amount of stimulation to occur within a selected time interval.

[0284] In an embodiment, the Restore treatment program is configured to provide a schedule of therapy events with set timing according to a defined induction interval, such as 28 days. For example, a symptom tracking protocol is used that first provides a baseline survey of the patient during onboarding. Alternatively, one or more baseline surveys are presented to the user before, during, or after a defined treatment session (e.g., during or after the first one or two treatments in the first week of treatment). The Restore treatment program is then programmed to survey the user at later time points, such as 2, 3, and / or 4 weeks, to measure symptom severity. The progress module 47 evaluates symptom change by comparing the subsequent survey results to the baseline survey results. Additionally, the Restore treatment program may report changes in at least one of the user's baseline symptoms and the later assessed symptoms, as calculated by the progress module 47 (FIG. 9a).

[0285] While these other events may occur at fixed times, they are adjustable, allowing the user to schedule activities and events related to a therapy regimen. For example, survey items can be set to present on specific days, or on a defined schedule such as every other day or every other week.

[0286] The Restore treatment program of the app 21 can operate the Progression module 47 to store one or more system-defined or user-defined treatment goals, such as reducing a symptom by a selected amount. At least one treatment goal can be selected by prompting the user to select the symptom the patient most wants to improve (e.g., nocturia) or by selecting a symptom goal (e.g., reduce the number of nocturia events by 1 or 2). When the goal meets one or more defined thresholds, the progress module 47 can present an encouraging message to the patient (i.e., provide a positive outcome treatment result) (e.g., "Congratulations, you have reduced nighttime events by X%, where "X%" is set to at least a defined set of percentages).

[0287] Coaching. The coaching capabilities of the NiNA digital health platform can improve outcomes, increase user engagement, improve adherence, reduce dropouts and undertreatment, and save healthcare professionals time, effort, and costs. Coaching allows NiNA to guide and remind users to ensure appropriate user activity occurs. This disclosure has provided many examples of how the Restore and Maintain programs provide coaching, such as user training on treatment and scheduled events defined as part of treatment. In embodiments, NiNA provides a therapeutic benefit independent of that provided by stimulation therapy or that complements or supports neurostimulation therapy, for example, behavioral coaching can provide timed messages to remind individuals to go to the bathroom on schedule or to discourage drinking alcohol just before bedtime.

[0288] Coaching 140 can include providing reminders and nudges, as well as providing information relevant to the patient's treatment, which is an important part of the user experience and can be particularly useful to present during a treatment session. These help support users towards successful treatment and include reinforcement with positive words and praise, reminders to recharge the device, and informational "snacks" to consume before, during and after treatment. There are also reminders provided by the coaching module to inform the user when it is time to resupply / replace the stimulation matrix pads ensuring a clean and usable pad that provides effective therapy. Coaching may also encourage / monitor usage by sending notifications to the user or selected caregiver regarding usage, symptom changes, non-compliance, etc.

[0289] Coaching is provided as part of the Restore and Maintain treatment programs to reinforce correct treatment. The system's treatment program can include behavioral training and prompts as part of coaching 140, including the use of an individualized toileting schedule for planned or prompted toileting. In one embodiment, the system only alerts the individual to prompt toileting according to a defined schedule. The system can also alert a caregiver or nursing station as part of a scheduled toileting program. Prompts can also be tied to activities such as bedtime, or the typical time when the resident "wets the bed", so that toileting occurs before a potential episode of incontinence. The toileting program can be related to the prevention of urinary or fecal incontinence, or both. The program can also be tailored to be more frequent if the user has co-morbid conditions such as urinary tract infections or ulcers related to moisture in the pelvic area.

[0290] In one embodiment, a data log is maintained that includes all therapy event types (stimulation sessions, scheduled survey questions, behavioral exercises such as Kegels, etc.). Compliance characteristics for each event are defined and user activity is logged. For example, a stimulation session may require the subject to provide stimulation for at least 30 minutes using a minimum amplitude level, a survey session may require that at least a minimum percentage of survey items be answered by the user, and behavioral exercises may require the subject to perform the exercises for at least a minimum of 5 minutes. How well a user meets the minimum criteria for an activity determines whether the activity is logged as compliant.In addition to defining event adherence characteristics, adherence evaluation rules are defined for each therapy event. For example, an adherence assessment rule may require that three consecutive stimulation sessions (or three stimulation sessions within a two-week period, e.g., 3 out of 14) be missed before a non-adherence event is recorded or flagged by the system, but for other events, the rule may be less lenient and even missing a single event may trigger an action.

[0291] When non-adherence occurs, coaching may include suggesting a surrogate event. For example, a surrogate treatment event may be used to meet the adherence criteria if defined by one or more assessment rules. For example, if a user misses two 30-minute treatment sessions, the user may be prompted or enabled to meet the treatment event adherence criteria by providing a 60-minute stimulus (instead of 30 minutes), which is defined as an acceptable surrogate treatment event. In one embodiment, the compliance assessment rules may allow a selected number of substitute treatment events to occur within a defined interval, such as one month, prior to the contingency of a non-compliance behavior, such as scheduling a user for a direct call with a medical professional.

[0292] In one embodiment, at least one of a) the number of surrogate events per defined interval, b) the adherence assessment rules, and / or c) the adherence notification rules are defined as a function of at least one of the induction phase, the maintenance phase, whether the patient showed minimal improvement or symptom relief as defined by the physician, or another defined condition.

[0293] In addition to recording, calculating, and displaying symptom-related trend data to allow the user to track progress, data and summary statistics related to all therapy events can be displayed to the user to encourage therapy adherence and increase the user's engagement in treatment.

[0294] In addition to user scheduled events, information about the disorder or specific to the user's symptoms can be provided as part of coaching to educate the user on a regular basis. For example, "pelvic floor trivia" can be personalized for each user. Summary statistics for the user can be calculated from logged data, including, for example, the average number of bladder voids per day or the average time between bladder voids, and this can be presented in the context of what may be seen as a disorder (or the extent to which it is seen by other users of the system).

[0295] To incentivize the user, the system may also present messages regarding therapy adherence or symptom improvement. For example, the number of urinations per day for each week for a month may be calculated, and a message regarding improvement may be presented to the user if such improvement meets a defined threshold. For example, a message may be displayed if urinary urgency was rated as low in a recent one-week window compared to the average urgency reported by the user during the first week of treatment or a one-week baseline period prior to starting treatment.

[0296] In one embodiment, the Restore program presents the user with a set of 3-10 survey items once or twice a week to assess symptoms. Changes in the user's symptoms compared to baseline symptoms that meet treatment criteria can trigger positive outcome treatment events, such as providing the user with progress graphs and encouraging messages. Additionally, if the change from baseline does not meet the treatment criteria, a negative outcome treatment event may be triggered, such as a) suggesting a remote meeting with a nurse practitioner, b) extending the Restore period for an additional period, or c) suggesting the user extend the treatment period to an hour per day at selected intervals (acting as a booster treatment).

[0297] In embodiments, the Restore program can be used to provide, supplement, or substitute for implantable device therapy. For example, a wearable device can be used to provide induction therapy for more than 21 days prior to implanting an implantable device, followed by less frequent maintenance therapy (e.g., 2-3 days per week). Alternatively, an implantable neurostimulator can be implanted and the patient allowed to heal before beginning a period of induction therapy using the Restore program. Alternatively, after implantation, a wearable neurostimulator, or a combination of external and implanted neurostimulators, can be used in the Restore program. The schedule on which the implanted device provides stimulation can be used to adjust the schedule of stimulation provided by the external device. For example, if the implanted device provides stimulation two days a week, the scheduled stimulation provided by the wearable can be adjusted so that stimulation is provided every day during induction and on the remaining days. The Restore program is adjusted to take into account the stimulation schedule of the implanted device.

[0298] The Restore program uses drip-feed information to provide coaching at scheduled times. The drip-feed algorithm is "smart" and will incidentally display information about a symptom (e.g., nocturia) only if the user indicated the presence of that symptom during user onboarding or if there is a symptom score for that symptom above a defined threshold indicating a problem.

[0299] In embodiments, the Restore program provides behavioral therapy exercises that have traditionally been delivered in person by a pelvic floor physical therapist or nurse practitioner. This coaching aspect of the system can undergo clinical trials to demonstrate efficacy independent of or in addition to neurostimulation without biomedical support, allowing the software to be qualified as a digital therapy, a "software as a medical device," or a "software-based therapy" that can be individually prescribed before activation as a feature.

[0300] Digital ecosystem, telemedicine and remote management of care In an embodiment, the curated treatment program includes features provided by the digital ecosystem such as: a) computer-assisted coaching 140 of behavioral and educational activities and training; b) computer-assisted therapy (such as cognitive behavioral therapy) to assist with retraining undesirable emotional states such as anxiety associated with the disorder, etc., per step 148 or 140; c) scheduled or event-based presentation of information related to the disorder or undesirable symptoms, per step 140; d) access to a library of reference information, per step 156; e) computer-assisted patient survey and symptom assessment, per step 142; f) progress tracking, per step 144; f) information regarding behavioral exercises, including video routines to guide the exercises, per step 140; g) information regarding nutrition or supplements that may improve undesirable symptoms of the disorder, per step 140 or 146. These features may be provided pursuant to a user request 156 or by a treatment program defined schedule 131 that is invoked as part of step 134 and uses patient prompts 138 to remind the user to perform an activity. Reminders are presented to the user 138 to improve treatment stimulus compliance according to a predefined or user defined treatment schedule or to encourage other user actions, behaviors, or activities that are beneficial to treatment.

[0301] Ecosystem parameter values ​​related to treatment delivery can be approximately fixed or can be initially adjusted in response to patient profile preferences and then further adjusted in response to treatment failure or progress assessed at one or more time points.

[0302] Onboarding has been disclosed and is used to create a patient profile that can be used to tailor the characteristics of a selected subsequent treatment regimen in response to the patient's data and preferences. As shown in FIG. 8b, as part of onboarding, the user's answers to survey questions provided at baseline in response to a user evaluation program are obtained 100 and evaluated (by software routines in onboarding module 50e) to create a user profile 102 stored in user profile module 50g. The system then concomitantly tailors its behavior 104 with respect to the user profile in accordance with a set of user profile rules defined in user profile module 50g. In an embodiment, the user profile rules can cause adjustment of the survey items presented (by the progress module 47) by the survey module 50f, symptoms tracked and used to calculate a treatment progress score, such that these are adjusted based on, for example, a) the patient's baseline characteristics in the patient profile (e.g., medical history, medical condition / severity, symptom bother ratings, etc.), and / or b) user input as to which treatment outcomes are most important, and c) the desired level of interaction with the system as indicated by the user. For example, survey module 50f may present a survey to the user and ask the user to select whether they would like a reminder about the stimulation therapy. The system may then act based on the user response data to adjust the frequency of patient education / coaching provided by coaching module 50h.

[0303] 9a through 9k show example views that may be selected and / or provided by the digital ecosystem module 50 of the system 12 during a treatment. An embodiment of the Restore program uses the functionality provided by these top-level screens to provide a curated treatment. Each screen represents a different functional category of the curated treatment. Examples of functionality include the following screens: FIG. 9a shows a screen 236 that provides a setting function that allows the user to adjust the settings of the authorized program, FIG. 9b shows a screen 238 that provides an onboarding function, provides educational content to the user, and trains the user on the delivery of treatment, a screen 240 shown in FIG. 9c describes the STAGE and schedule features, a screen 242 shown in FIG. 9d provides a control function including INTENSITY and LOCATION field controls, a screen 244 shown in FIG. 9e provides a user input function including an anatomical survey that can confirm correct treatment, a screen 246 shown in FIG. 9f provides a function related to monitoring and displaying therapy compliance, screens 248 and 250 shown in FIGS. 9g and 9h provide a function related to user input, symptom display and tracking, a screen 252 shown in FIG. 9i provides a function related to tracking progress, a screen 254 depicted in FIG. 9j provides a function to provide positive feedback and goal announcements as part of coaching, and a screen 256 shown in FIG. 9k provides a function to notify the user of progressing to a new stage of the treatment regimen.

[0304] The program can track user adherence in performing scheduled therapy sessions and can provide reminder prompts as part of coaching the user 140 to perform therapy sessions according to selected preferences (e.g., reminders can be sent via email, phone text, and / or push notifications, as well as provided by audio or vibration alert signals). During the course of treatment, the program promotes therapy adherence by providing alerts, monitoring, storing / tracking, evaluating, and displaying adherence. For example, the program shows the actual history of treatment sessions scheduled by the user versus those completed by the user (e.g., FIG. 9f).

[0305] 9a illustrates one embodiment of a menu screen displayed by user device 20a that allows a user to select different functions of the ecosystem. The menu includes items that allow the user to view or interact with the following functions: User Profile, which allows the user to create or "login" to an account that contains user data, including user profile information: a) A home screen that provides tiles to access different areas of the ecosystem and displays information about the treatment, such as how many days per week stimulation is required and the current number of treatments; b) A treatment screen that allows initiation and control of treatment sessions; c) A history screen that displays information such as days stimulated or missed, as well as treatment adherence information, statistics or scores, a timeline or calendar showing days treatments were provided or are scheduled to be provided, or other events such as the completion of user surveys, education, and scheduled dates and times of remote sessions with health professionals; d) A trends screen that shows trends in scores related to symptoms, bothers, or goals; e) A "Learn" screen that provides a starting point for accessing educational content, including a digital library of facts and videos; f) A support screen that allows the user to contact technical or clinical support resources via remote technical / medical assistance, as well as video tutorials, user guides, and instructions related to using the system; g) A digital store with a shopping cart function; h) A settings section to allow the user to review and adjust settings related to the treatment.

[0306] The system may also assess the user for nutritional deficiencies due to inadequate caloric intake, and nutrients and supplements can be suggested by the coaching module or ordered using the app21, as well as absorbent pads, replacement stimulation matrices, etc. These can also be provided on a regular basis as part of a monthly paid subscription to the NiNA service.

[0307] While the menu in Figure 9a allows the user to select different features of the ecosystem and provide treatment in a preferred embodiment, the app 21 software typically provides a guided experience that guides the user through onboarding and interacts with selected portions of the program on a schedule according to a predefined treatment regimen. In another embodiment, the predefined treatment regimen (including the treatment schedule) is adjusted based on at least one of user preferences, changes in symptom severity, and user adherence.

[0308] One selection in the menu is "Treat," which may take the user to a treatment screen shown in FIG. 9d. Instead of using the controls to set the stimulation parameters, the user may select the option "User Preset." In an embodiment, the control module 40 of the device 12 (or user device 20) allows the user to save treatment settings (e.g., stimulation or user notification parameters) according to user preferences. Settings and parameter values ​​may be hard-coded or selected and adjusted by the user. The system may also reuse settings previously selected by the user for the stimulation treatment, including parameter values ​​of stimulation signal characteristics (e.g., intensity, pulse width, frequency range) and stimulation montage settings (e.g., weighting values ​​defined for combinations of active channels defined as anode and cathode). For example, if the user selects to use a previously saved treatment protocol parameter value, then at the start of a treatment session, control module 40 operates stimulation module 42 to slowly increase the amplitude of stimulation to the amount used in the previous treatment session over an interval, such as 5 to 15 seconds. The system then "ramps" or otherwise transitions to the same stimulation protocol parameter values ​​used at the end of the previous treatment session, which involves manipulating the stimulation matrix in a selected manner.

[0309] 9b illustrates a sample introduction screen provided to a new user as part of the onboarding program introduction 102 defined in onboarding module 50h. The screen displays an instructional video selected from reference module 50b that is narrated by a clinician and provides education on peripheral targets such as SAFN, describes the mechanism of action for treatment of the disorder, includes an instructional lesson on how to properly apply the device to stimulate the target nerve, and includes other information to introduce the user to treatment, such as how to use the stimulation matrix and how to modify stimulation parameters.

[0310] FIG. 9c shows examples of predefined treatment regimens. These include a curated “Restore” program that provides initial induction stimulation on a more intensive schedule (e.g., daily or longer sessions), and a “Maintain” program that provides a less intensive treatment maintenance program (e.g., every other day, or 2-3 days per week, or shorter sessions). In one embodiment, both the Restore and Maintain programs are configured to guide the user to provide treatment according to a predefined regimen. However, in an embodiment, the user is permitted to customize the program according to a set of permitted adjustments and ranges that characterize the scheduled events.

[0311] FIG. 9d shows a treatment ("Treat") screen with timer and controls. The bottom of the screen provides a location for providing notifications during the treatment session prompting the user to participate in various types of treatment events, such as viewing educational content or completing survey items. The screen also provides controls for the stimulus montage, including stimulus intensity and location.

[0312] FIG. 9e shows a screen in which the user is surveyed to provide the anatomical location of the stimulus-induced paresthesia, which may then be followed by a screen surveying the intensity and quality of the paresthesia.

[0313] Figure 9f shows a History screen with a treatment calendar with icons informing about treatment delivery and therapy adherence. This screen may include notifications with therapy adherence scores, progress updates, reminders, or encouragement (e.g., "Excellent Job," "You still have a survey to complete") that can be displayed at the top of the screen based on an assessment of the status of a series of calendar events related to adherence criteria for the treatment regimen.

[0314] 9g and 9h provide functionality related to user input and tracking of symptoms at baseline (e.g., captured during onboarding) and subsequently during treatment, respectively. The symptoms are qualitatively scored using symptom assessment criteria as "normal," "moderate," or "high," with ranges of symptom scores defined.

[0315] FIG. 9i provides the ability to provide feedback to the user to track progress.

[0316] FIG. 9j provides the ability to provide positive feedback and goal announcements as part of the coaching provided during the treatment interval. Treatment goals may be set as defaults or may be derived at step 142 during or after the onboarding process 100. Providing encouraging notifications as part of the coaching can increase the user's motivation as treatment progresses.

[0317] FIG. 9k provides a feature to inform the user that they are moving to a new stage in their treatment regimen, such as from induction to maintenance.

[0318] Anatomical data and device mapping. In an embodiment, the training operation of step 104 or the coaching operation of step 140 are used in conjunction with the anatomical image. For example, in step 104, the coaching module 50h provides user instructions on how to properly position the device for intended stimulation of the anatomical region, as shown in FIG. 10b. The image may show the device properly positioned and worn on the leg or overlaid.

[0319] In an embodiment, training 104 includes obtaining user input about anatomical data and sensations associated with stimulation. For example, the user is surveyed 142 to provide data regarding device placement, evaluation of stimulation, and whether neural recruitment was successful. This includes indication of relevant body parts, such as legs and feet in the case of SAFN stimulation, and arms and hands in other applications. The user can move the virtual image of the device along the image until it corresponds to the position the user has decided to wear it in, or simply draw an "x" where the device is to be worn. The training module 104 can provide feedback as to whether this is correct or incorrect. The user may also be probed for the location of any skin irritation or paresthesia. Usability and training outcomes can be improved by selecting or adjusting anatomical images based on the user's demographics, gender, height, weight, body type, or other characteristics of the user input by the user. If the user responds that she is a 65 year old black female, then the leg image is selected from a library of leg images or line drawing representations stored in reference material module 50b. If the library contains images of three age groups, two genders, and four races (black, white, Asian, Latino, etc.), the image library of module 50b may contain 24 images.

[0320] Alternatively, during the onboarding user survey 108, the onboarding module 50e can prompt the user to take a picture of their leg, whether or not the wearable device is attached. The EM module 46 can instruct the user to operate the digital camera of the user device to capture an image of the device being worn that is stored in the reference module 50b. As part of the coaching 140, at scheduled times during the treatment interval, this image can be presented to the user by the app 21 before allowing the user to begin stimulation to increase consistency of device placement. The system can also survey the user to take additional photographs of the device being worn according to a schedule. This may entail taking a photograph at the beginning or end of every treatment session. The image is stored in a user log. It can then be transmitted along with the log information to a remote computer 20f and reviewed by a medical professional to determine whether device placement is consistently correct.

[0321] Virtual / Augmented Reality Mapping. In an embodiment, the digital ecosystem module 50 includes a virtual module 50a that, under control of the app 21, provides virtual reality (VR) or augmented reality (AR) capabilities in combination with camera / video images recorded by the user's smartphone user device 20a. For example, the module 50a software merges images captured by the camera / video with images indicating where the user's saphenous nerve is likely to be located (e.g., previously established through image data or other mapping data generated for the user, or based on population data) to improve nerve targeting. The mapping data can include locations where target nerves were previously successfully recruited. For example, if a physician evaluates a patient and places the stimulation matrix 16 at a location, the associated VR image of that location is overlaid as a ghost image on the real-time image recorded by the camera. The user can adjust the actual real-life (RL) position of the device until it overlaps with the virtual image. VR can be used to help confirm correct placement of the stimulation matrix when used alone at home. The VR / RL comparison can be stored or transmitted to a remotely located computer 20f to enable remote guidance to the patient.

[0322] Feedback using sensory data In an embodiment, the system includes a sensing module 44 configured to record and process SNAP and / or EMG data. The sensed data signal may be filtered and provided to a display or speaker to allow the user to hear the evoked activity as opposed to background activity. The recorded signal may be averaged over a selected period such as 30 seconds (e.g., a 5 second segment including 6 averaged recordings) before being presented to the user. The sensed data may also be displayed on a grid showing a thermal signature of the SNAP amplitude (or other measure of evoked potential strength) as a function of where the stimulation signal centroid is located on the stimulation matrix.

[0323] In one embodiment, the sensory data can be used to allow for adjustment of the stimulation signal to provide neuromodulation but below the sensory threshold. This is useful when therapy is provided while the subject is asleep. In one method, the amplitude of the stimulation is increased until the subject confirms a sensory perception of recruitment. The amplitude level is then decreased in steps (e.g., 5%) to determine if the stimulation is sufficient to elicit a neural response.

[0324] In embodiments, the sensed data can be used to assess or confirm neural recruitment associated with the selection of amplitude, location of stimulation (i.e., field geometry), and selection of a stimulation montage from a set of defined montages. This can occur in a closed-loop manner that automatically adjusts stimulation parameters (amplitude, location) to maintain a sensed response from nerves that meet at least one detection criterion.

[0325] If SNAP recording and detection is used to confirm recruitment of SAFNs (in the case of an implantable or wearable device), at least one of the first pair of conductive pads can be placed on top of the stimulation matrix (to record antidromic potentials) and a second pair can be placed underneath (to record orthodromic potentials), or both can be used. When both antidromic and orthodromic responses are recorded as objective measures, the two measures can be compared, combined, or evaluated separately to confirm recruitment. Confirmation of neural recruitment may require detection of at least one or both measures. Furthermore, the relative latency of the two measured evoked responses (nerve conduction velocity) can be compared as part of the response evaluation.

[0326] When sensed data is used to confirm recruitment and set stimulation settings in either an open-loop or closed-loop embodiment, the SaphLevel and SaphLocate functions of the present invention can be used to maintain "recruitment" of the target nerve. For example, non-primary channel amplitude weighting can be set above zero and increased to achieve or maintain successful recruitment of the target nerve. Sensed data may also be used by the system in a closed-loop system that employs a control law to maintain recruitment amplitude or latency measurements within a selected range.

[0327] Physician Locator / Connections. In an embodiment, a trigger is defined in the system 10a to prompt the user to connect with a physician for an in-person or virtual visit. In step 126, the system can prompt the user to contact a physician if the user profile indicates that the patient may be unsuitable for treatment (e.g., suffers primarily from stress urinary incontinence rather than OAB). In an embodiment, a negative outcome treatment event, which may be evaluated when evaluating treatment progress in step 144, serves as a trigger that causes the system 10a to provide a defined contingency action. The system may send a flag value to the remote computer 20f that may be used to modify the patient's record and scheduled for review by a qualified medical professional at the service provider. If merited, this may prompt the user to be contacted in a defined manner or schedule a remote telehealth or in-person visit. Also, in an embodiment, in step 144, the system may implement a physician locator / connect function that includes any of the following operations: The locator / connect function is implemented by locator / connect module 50k, which uses the patient's location information (assessed by address, zip code, or other location information) to provide the user with a list of nearby "EBT approved" urologists (or urology clinics) from which the user can select. The list may also be based on additional information stored or requested by the system, such as the user's age and medical / medication history. The patient can select a physician, may be given the physician's contact information, and may be presented with the option to connect to a clinic to schedule an appointment, or schedule a face-to-face or video consultation using the system software in the Locator / Connect Module 50k. The patient may be connected to a specialist incidentally based on having a sufficient number of purchased "credit units" remaining. The medical session may also be conducted using text messaging or chat features, or even a mobile phone.

[0328] As part of step 144, upon accepting the user's request for a medical consultation, the locator / connect module may operate to request user permission to transmit information to the physician (ie, the clinic's computer 20c). In one embodiment, the user must affirmatively authorize the item to be sent to the physician and provide a signature on the touch-sensitive screen of the user device 20a presented by the locator / connection module 50k. Such information includes insurance information, billing and address information, relevant medical history, and any information stored by the system 10a on the neurostimulator 12, the remote computer 20f, or the user device (e.g., the user's smartphone 20a operating the app 21). Such information may include, for example, all information captured during patient onboarding, user profile information, responses to questionnaire items presented to the user, log information including stimulation history including duration and parameter values, adherence summary, notes from previous consultations with medical professionals (associated with the user's unique ID number and stored in the cloud), and other information regarding the user's medical history. When a consultation session is scheduled, the event may be added to the system's software calendar or the smart device calendar and a reminder may be provided.

[0329] Negative treatment outcomes assessed in step 144 may lead to additional events 134, such as education via internet seminars on lifestyle changes or other treatments, or may lead to suggestions (by the user or physician) to incorporate alternative interventions that can be added to the neurostimulation therapy (e.g., delivery of software-based therapy). If a user views a video about an implanted neurostimulator and wishes to meet with a physician to further discuss, the locator / connection module 50k may limit the potential physicians presented to the user to those physicians who are qualified to provide that treatment or who are otherwise selected.

[0330] In one embodiment, when a doctor or clinic is selected by a user operating the locator / connection module 50k, the user is provided with the option to select the involvement of the doctor as part of the treatment plan and can choose to share summary or real-time data on an ongoing basis.

[0331] In an embodiment, the digital ecosystem provided by module 50 includes a physician locator function that includes module 50k and can be triggered by events such as: If a positive response is obtained in step 108 during onboarding to a survey or series of items designed to identify a condition requiring medical evaluation in step 126, as part of step 126, based on the user's medical history or medication information. During treatment, if at step 144 it is determined that the user's treatment goal has failed, the user is prompted with the option to connect to a nearby doctor / clinic. If the user requests a clinic visit via the app 21 as part of step 146 and for reasons known only to the user. Part of step 148 may include a scheduled remote review of the user's data by a medical professional (e.g., if defined in a treatment schedule or scheduled remotely due to a detected medical event, such as a lack of treatment efficacy). If the user is prompted at step 148 due to a flag in the user profile due to an expired prescription. Or the physician reviews other information at remote site 20c and determines that a referral to a medical facility is warranted.

[0332] In an embodiment, the connection to the local physician in step 146 is made through a telemedicine application of the telemedicine module 50d, which provides software for videoconferencing with a physician, allowing for the request or scheduling of a clinic or telemedicine appointment, providing contact information for the clinic, or offering a remote meeting with a nurse practitioner who can connect the user with an appropriate local physician.

[0333] A local physician is identified as a physician retrieved from a database of a system that retrieves local physicians using at least one of the following: Your location as identified by GPS or zip code; insurance company information provided by you; information stored in our system about your doctor or urologist; or other methods. Furthermore, the methods used and physician selected may be adjusted based on factors that prompted the user to contact a physician, such as responses to a survey suggesting a set of symptoms that meet criteria for referral to a physician for further evaluation, such as failure of a treatment protocol (e.g., evidence of a non-OAB comorbidity, medical condition, or disorder, potentially worthy of evaluation).

[0334] Contact Log In addition to the therapy program 130 updating log information as part of the start / stop process 132 , this may occur in step 150 in connection with connecting with a remote medical professional in step 150 . In one embodiment, the system includes computer readable software code in the user interface module 48 that manages the telehealth operations of the telemedicine module 50d and operates the log module 50m to create a data log of the user's remote telehealth history. A contact log field allows tracking of the time and content of user messages that the user may send to medical professionals in a remote medical service. The contact log managed by the log module 50m also stores data related to the user providing "event tagging" of potential related medical events as part of step 150, which is invoked when the user enters information related to an event that they wish to save or review (e.g., an episode of urinary retention). The log module 50m may also record the time and content of questions posed to the remote service (and answers received). These may include voice recordings or text messages sent to the remote service's computer 20f for review, or information stored locally on the system 10a for later uploading and review.

[0335] Calendar export / milestone notifications In an embodiment, the digital ecosystem module 40 provided on the user device 20a via the app 21 is designed to integrate with the smartphone's calendar program, such that scheduled therapy events defined in the Renew / Maintain program can be displayed on the calendar screen (see FIG. 9f) and the app can provide "push" or other notifications to the user under the alerts module 50j. However, the communication module 45 can communicate export data from within the application 21 as events or activities with defined reminders to a calendar specified by the user (e.g., export to the user's Outlook or Google calendar using a ".ics" or ".vcs" file). Historical events and status (e.g., completed / incomplete) and scheduled future events are maintained by the app 21 (along with logs or other information stored on the device 12 and / or remote computer 20f) to form a complete record of events. This includes, for example, when a stimulation session was scheduled, skipped, or occurred; “win moments,” such as when a patient achieved a specific treatment goal (e.g., a goal assessed over a selected time period, such as “zero leakage for the last 5 days,” “slept through the night for the last 3 days,” or “received stimulation every day for 14 days, i.e. 100% adherence”).

[0336] Similar to the consolidation of log file information for purposes of calendar export, the coaching module 50h can apply adherence criteria to the entire consolidated log file information that may be stored on the neurostimulator 12, the user device 20a, and / or the remote computer 20f. For example, if a user uses the neurostimulator 12 without the user device 20a to provide one or more stimulation sessions, adherence criteria must be applied to the consolidated log file after importing the usage data from the neurostimulator 12. In an embodiment, this is defined to occur at the start or end of a therapy session 132.

[0337] Implantable Devices The present invention can be realized using an implantable device rather than or in addition to a wearable neurostimulator. The implantable device can be cylindrical like the BION or e-Coin, or can use paddle leads or other electrode form factors. Alternatively, the form factor can be a slightly recessed housing that corresponds to a notch running along the tibia. There may be only one contact (relative to the housing) to provide stimulation, or there may be a set of two or more contacts, in which case the field steering controls and methods disclosed for the wearable system are used as well.

[0338] When stimulating the PTN, potential stimulation locations can be confirmed by visually or otherwise detected motor activity, such as changes in EMG or motor evoked potentials (MEPs) (e.g., flexing the first toe or fanning out all toes). In contrast, potential locations for SAFN stimulation require the subject to confirm an evoked sensation, such as pa...

Claims

1. a stimulation module having at least one electrical stimulation generator for transmitting electrical signals through a plurality of electrical generator channels; a control module electrically coupled to the at least one electrical stimulator generator for activating or deactivating each of the electrical generator channels according to a predetermined stimulation protocol having at least two sets of stimulation montages with defined weighting values ​​for each set of activated pads; a wearable stimulation matrix defining a plurality of electrical stimulation pad pairs adapted to be removably secured and positioned in a predetermined arrangement on an outer surface of a user's skin to enhance transcutaneous stimulation of neural targets in the user's extremities, each of the electrical stimulation pad pairs having a cathode pad and an anode pad electrically coupled to respective cathode and anode electrical generator channels, each of the electrical stimulation pad pairs (1) being in an active state when the respective electrical generator channel is activated, and (2) being in an inactive state when the respective electrical generator channel is deactivated; a first stimulus montage defined for the pads of the wearable stimulus matrix, each of the electrical stimulation pads being in the active state or in the inactive state with a first weighting value selected according to the predetermined stimulation protocol; a second stimulus montage defined for the pads of the wearable stimulus matrix, wherein at least one of the electrical stimulation pads is in the inactive state or in the active state with a second weighting value different from the first weighting value when at least one of the electrical stimulation pads is in the active state with the first weighting value in the first stimulus montage; a user interface device that allows for user input used to transition the wearable stimulation matrix from the first stimulation montage to the at least second stimulation montage according to a set of predefined montages defined by the predetermined stimulation protocol during a transcutaneous stimulation treatment of the user; A transdermal stimulation system comprising:

2. 10. The transdermal stimulation system of claim 1, wherein the plurality of electrical generator channels comprises at least four electrical generator channels.

3. 10. The transdermal stimulation system of claim 1, wherein the wearable stimulation matrix has at least four electrical stimulation pads.

4. The transdermal stimulation system of claim 3 , wherein the electrical stimulation pads of the wearable stimulation matrix are staggered relative to one another in a predetermined geometric pattern.

5. 2. The transdermal stimulation system of claim 1, further comprising a stimulation protocol for the stimulation module that defines a set of predefined stimulation montages for the wearable stimulation matrix, each of the predefined stimulation montages having individualized electrical stimulation pads (a) having a predefined activation state with a weighting value defined for each of the set of activated pads, or (b) having a predefined inactivation state; The transdermal stimulation system of claim 1 .

6. 2. The transdermal stimulation system of claim 1, further comprising electrical generator settings for the first and second stimulation montages that are operably adjusted to satisfy at least one sensory criterion of at least one of the users, the transition between the first and second stimulation montages being operatively adjusted to satisfy at least one sensory criterion of at least one of the users.

7. 7. The transdermal stimulation system of claim 6, wherein the at least one perceptual criterion is defined such that the transition between the first and second stimulus montages exceeds a noticeable difference found with a group of users, thereby designing the transition to be more noticeable to the user.

8. 8. The transdermal stimulation system of claim 7, wherein the perceptual criteria are defined such that the transition between the first and second stimulation montages can occur without an intensity jump perceived by the user exceeding a selected level, thereby designed to make the user more susceptible to paresthesia induced by changes in recruitment.

9. 2. The transcutaneous stimulation system of claim 1, wherein the weighting values ​​defined for each channel are used to adjust at least one of the amplitude of a stimulation signal provided by an electrical generator stimulation channel associated with a pad and the pulse width of a stimulation pulse of a stimulation signal provided by an electrical generator stimulation channel associated with a pad.

10. 2. The transdermal stimulation system of claim 1, wherein the amplitude of the electrical generator signal in at least a set of stimulation pads of the second stimulation montage is set (a) as a predetermined percentage of the electrical signal amplitude in the first stimulation montage and (b) differentially related to the number of activated stimulation pads.

11. the first stimulus montage includes two active stimulus pads; the second stimulus montage includes four active stimulus pads; the amplitude of the electrical generator signal for at least some of the channels of the second stimulus montage is at least 50% greater than the amplitude in the first stimulus montage; The transdermal stimulation system of claim 10.

12. the first stimulation montage includes two active electroactive stimulation pads; the second stimulation montage includes four active electroactive stimulation pads; the electrical generator signals for at least some of the channels of the second stimulus montage are within 60% to 90% of the electrical generator signals of the first stimulus montage; The transdermal stimulation system of claim 10.

13. the first stimulation montage having six electrical stimulation pads in the active state each coupled to an electrical generator channel; each of said electrical generator channels having a weighted amplitude signal ranging from 70% to 100% of a predetermined electrical signal in five of said stimulation montages for providing a predetermined amount of stimulation between oppositely disposed electrical stimulation pads; The transdermal stimulation system of claim 1 .

14. 2. The transcutaneous stimulation system of claim 1, wherein the set of stimulation montages includes a selected set of montages that are pre-presented in a patient group when the stimulation montages are sequentially selected to provide a normally perceptible shift of an electrical field from one side of the wearable stimulation matrix to an opposite side of the wearable stimulation matrix in a transition from the first stimulation montage to at least the second stimulation montage.

15. The transdermal stimulation system of claim 1 , wherein the set of stimulation montages includes between three and seven stimulation montages.

16. The transdermal stimulation system of claim 1 , wherein the set of stimulation montages includes five stimulation montages.

17. The transdermal stimulation system of claim 1 , wherein the set of stimulation montages further includes a montage defining a montage in which all channels have approximately the same weighting.

18. 2. The transcutaneous stimulation system of claim 1, wherein the wearable stimulation matrix and montage are positioned in a mid-leg region of the user and operate as parts of a wearable device that provides transcutaneous stimulation to the user's saphenous nerve by providing targeted stimulation to the mid-leg region of the user.

19. The transdermal stimulation system of claim 18 , wherein the wearable device is secured to the user's leg by an elastic band.

20. 20. The transdermal stimulation system of claim 19, wherein the set of stimulation montages includes a selected sequence of montages that, as the stimulation montages are selected in sequence, move maxima of the electrical field strength from one side to the other side of the wearable stimulation matrix.

21. 2. The transcutaneous stimulation system of claim 1, wherein the wearable stimulation matrix and montage are adapted to provide transcutaneous stimulation to the user's saphenous nerve using a set of pairs of stimulation pads and montages arranged vertically to enable a stimulation field to move from a left side of the wearable stimulation matrix to a right side of the wearable stimulation matrix to provide targeted stimulation to a mid-leg region of the user.

22. 15. The transdermal stimulation system of claim 14, wherein the set of stimulation montages includes a selected sequence of montages that, as the stimulation montages are selected in sequence, move maxima of the electrical field strength from one side to the other side of the wearable stimulation matrix.

23. 2. The transcutaneous stimulation system of claim 1, wherein all of the plurality of electrical stimulation pad pairs have a weighting value greater than 0 such that all of the pads are active in both the first and second stimulation montages.

24. the set of stimulus montages comprises between three and seven stimulus montages; 2. The transdermal stimulation system of claim 1, wherein the user interface device that enables user input used to transition the wearable stimulation matrix from the first stimulation montage to the at least second stimulation montage enables the transition only by the user repeatedly selecting stimulation montages according to a predefined order.

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