Implantable Device Programming Management

Abstract

An implantable device programming management system is disclosed, and an example of the system may include a processor subsystem; and a memory device including instructions, which, when executed by the processor subsystem, cause the processor subsystem to: receive a request to modify an application at an application executed on a user device; send the request to a management user device for approval; receive a response to the request from the management user device; and modify the functionality of the application in response to receiving the response.

Description

[0001] This application is a divisional application of the Chinese patent application with application number "201780006473.4", application date "January 11, 2017", and title "Programming Management of Implantable Devices".

[0002] Priority claim

[0003] This application claims priority under 35 USC §119(e) to U.S. Provisional Patent Application Serial No. 62 / 277,753, filed on January 12, 2016, which is incorporated herein by reference in its entirety. Technical Field

[0004] This document relates generally to medical devices and, more particularly, to systems, devices, and methods for managing the programming of such devices. Background Art

[0005] Neuromodulation including neurostimulation has been proposed as a treatment for many diseases. Examples of neurostimulation include spinal cord stimulation (SCS), deep brain stimulation (DBS), peripheral nerve stimulation (PNS), functional electrical stimulation (FES). Implantable neurostimulation systems have been applied to deliver such treatments. Implantable neurostimulation systems can include an implantable neurostimulator, also referred to as an implantable pulse generator (IPG), and one or more implantable leads each including one or more electrodes. The implantable neurostimulator delivers neurostimulation energy through one or more electrodes placed on or near a target site in the nervous system. An external programming device is used to program the implantable neurostimulator with stimulation parameters that control the delivery of the neurostimulation energy.

[0006] Neurostimulation energy can be delivered in the form of electrical neurostimulation pulses. Delivery is controlled using stimulation parameters that specify the spatial (where to stimulate), temporal (when to stimulate), and information (the pulse pattern that directs the nervous system to respond as desired) aspects of the pattern of neurostimulation pulses. Many current neurostimulation systems are programmed to deliver periodic pulses continuously or in bursts using one or a few uniform waveforms. However, neural signals can include more complex patterns to convey various types of information, including sensations of pain, pressure, temperature, etc.

[0007] Recent studies have shown that it is possible to improve the effectiveness and efficacy of certain neurostimulation treatments and reduce their side effects by using neurostimulation pulse patterns that mimic natural patterns of neural signaling observed in the human body. Summary of the invention

[0008] Example 1 includes a subject matter (such as a device, apparatus, or machine) comprising: a processor subsystem; and a memory device comprising instructions that, when executed by the processor subsystem, cause the processor subsystem to: receive a request to modify an application at an application executing on a user device; send the request to an administrative user device for approval; receive a response to the request from the administrative user device; and modify a function of the application in response to receiving the response.

[0009] In Example 2, the subject matter of Example 1 may include, wherein the request to modify the application includes a request to add a new feature to the application.

[0010] In Example 3, the subject matter of any one of Examples 1 to 2 may include, wherein the response is provided by a physician using an administrative user device.

[0011] In Example 4, the subject matter of any of Examples 1 to 3 may include instructions that, when executed by the processor subsystem, cause the processor subsystem to connect to an application repository to obtain a different version of the application after receiving the response to the request, and wherein the instructions to modify the functionality of the application include instructions to install a different version of the application to replace the application.

[0012] In Example 5, the subject matter of any one of Examples 1 to 4 may include, wherein the instructions to modify functionality of the application in response to receiving the response include instructions to enable the new feature in the application.

[0013] In Example 6, the subject matter of any one of Examples 1 to 5 may include, wherein the request to modify the application comprises a request to modify a stimulation parameter of an implantable pulse generator.

[0014] In Example 7, the subject matter of any one of Examples 1 to 6 may include, wherein the instructions to modify the functionality of the application in response to receiving the approval include instructions to update the application to program the implantable pulse generator with stimulation parameters.

[0015] In Example 8, the subject matter of any one of Examples 1 to 7 may include, wherein the request to modify the application to modify stimulation parameters is made after an evaluation period.

[0016] In Example 9, the subject matter of any one of Examples 1 to 8 may include, wherein the evaluation cycle includes interacting with a technician to systematically test various stimulation parameters.

[0017] In Example 10, the subject matter of any of Examples 1 to 9 may include, wherein the response to the request is approval of the change, and wherein the memory includes instructions that, when executed by the processor subsystem, cause the processor subsystem to adjust stimulation parameters based on the approval of the change for additional evaluation.

[0018] In Example 11, the subject matter of any one of Examples 1 to 10 may include instructions that, when executed by the processor subsystem, cause the processor subsystem to resubmit the request for approval after the adjustment of the stimulation parameters.

[0019] In Example 12, the subject matter of any of Examples 1 to 11 may include, wherein the response to the request is a denial of the request, and wherein the memory includes instructions that, when executed by the processor subsystem, cause the processor subsystem to present a notification on the user device, the notification including a reason why the request was denied.

[0020] In Example 13, the subject matter of any one of Examples 1 to 12 may include, wherein the user device comprises a smartphone.

[0021] Example 14 includes a machine-readable medium comprising instructions, which, when executed by a machine, cause the machine to perform the operations of any one of claims 1-13.

[0022] Example 15 includes a method of performing the operations of any of Claims 1-13.

[0023] Example 16 includes a subject matter (such as a device, apparatus, or machine) comprising: a processor subsystem; and a memory device comprising instructions that, when executed by the processor subsystem, cause the processor subsystem to: receive a request to modify an application at an application executing on a user device; send the request to an administrative user device for approval; receive a response to the request from the administrative user device; and modify a functionality of the application in response to receiving the response.

[0024] In Example 17, the subject matter of Example 16 may include, wherein the request to modify the application comprises a request to add a new feature to the application.

[0025] In Example 18, the subject matter of any one of Examples 16 to 17 may include, wherein the response is provided by the physician using an administrative user device.

[0026] In Example 19, the subject matter of any of Examples 16 to 18 may include instructions that, when executed by the processor subsystem, cause the processor subsystem to connect to an application repository to obtain a different version of the application after receiving the response to the request, and wherein the instructions to modify the functionality of the application include instructions to install a different version of the application to replace the application.

[0027] In Example 20, the subject matter of any one of Examples 16 to 19 may include, wherein the instructions to modify the functionality of the application in response to receiving the response include instructions to enable the new feature in the application.

[0028] In Example 21, the subject matter of any one of Examples 16 to 20 may include, wherein the request to modify the application comprises a request to modify a stimulation parameter of an implantable pulse generator.

[0029] In Example 22, the subject matter of any one of Examples 16 to 21 may include, wherein the instructions to modify the functionality of the application in response to receiving the approval include instructions to update the application to program the implantable pulse generator with stimulation parameters.

[0030] In Example 23, the subject matter of any one of Examples 16 to 22 may include, wherein the request to modify the application to modify stimulation parameters is made after an evaluation period.

[0031] In Example 24, the subject matter of any one of Examples 16 to 23 may include, wherein the evaluation cycle includes interacting with a technician to systematically test various stimulation parameters.

[0032] In Example 25, the subject matter of any of Examples 16 to 24 may include, wherein the response to the request is approval of the change, and wherein the memory includes instructions that, when executed by the processor subsystem, cause the processor subsystem to adjust stimulation parameters for additional evaluation based on the approval of the change.

[0033] In Example 26, the subject matter of any one of Examples 16 to 25 may include instructions that, when executed by the processor subsystem, cause the processor subsystem to resubmit the request for approval after the adjustment of the stimulation parameters.

[0034] In Example 27, the subject matter of any of Examples 16 to 26 may include, wherein the response to the request is a denial of the request, and wherein the memory includes instructions that, when executed by the processor subsystem, cause the processor subsystem to present a notification on the user device, the notification including a reason why the request was denied.

[0035] Example 28 includes a subject matter (such as a method for performing an action, an apparatus, a machine-readable medium comprising instructions that, when executed by a machine, cause a machine to perform an action, or an apparatus to be executed), comprising: receiving a request to modify an application executing on a user device; sending the request to an administrative user device for approval; receiving a response to the request from the administrative user device; and modifying functionality of the application in response to receiving the response.

[0036] In Example 29, the subject matter of Example 28 may include, wherein the request to modify the application comprises a request to add a new feature to the application.

[0037] In Example 30, the subject matter of any one of Examples 28 to 29 may include, wherein the response is provided by the physician using an administrative user device.

[0038] In Example 31, the subject matter of any one of Examples 28 to 30 may include, after receiving the response to the request, connecting to an application repository to obtain a different version of the application; and wherein modifying the functionality of the application includes: installing a different version of the application to replace the application.

[0039] In Example 32, the subject matter of any one of Examples 28 to 31 may include, wherein modifying the functionality of the application in response to receiving the response comprises enabling the new feature in the application.

[0040] In Example 33, the subject matter of any one of Examples 28 to 32 may include, wherein the request to modify the application comprises a request to modify a stimulation parameter of an implantable pulse generator.

[0041] In Example 34, the subject matter of any one of Examples 28 to 33 may include, wherein modifying the functionality of the application in response to receiving the approval comprises updating the application to program the implantable pulse generator with stimulation parameters.

[0042] Example 35 includes a subject matter including instructions (such as a machine-readable medium, a computer-readable medium, or other storage instructions) that, when executed, cause a device to: receive a request to modify an application at an application executing on a user device; send the request to an administrative user device for approval; receive a response to the request from the administrative user device; and modify the functionality of the application in response to receiving the response.

[0043] This summary of the invention is an overview of some of the teachings of the present application and is not intended to be a unique or thorough treatment of the present subject. Further details about this subject are found in the detailed description and the appended claims. Upon reading and understanding the following detailed description and viewing the accompanying drawings that form a part thereof, other aspects of the present disclosure will be apparent to those skilled in the art, and each of the other aspects will not be adopted in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Various embodiments are shown by way of example in the figures of the accompanying drawings. These embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the subject matter.

[0045] Figure 1 A portion of the spinal cord is shown.

[0046] Figure 2 Embodiments of neural modulation systems are shown by way of example.

[0047] Figure 3 By way of example, it is shown that Figure 2 An embodiment of a modulation device implemented in a neural modulation system.

[0048] Figure 4 By way of example, it is shown that an example such as can be implemented as Figure 2 An embodiment of a programming device for a programming device in a neural modulation system.

[0049] Figure 5 Portions of implantable neuromodulation systems and environments in which the systems may be used are shown by way of example.

[0050] Figure 6 Embodiments of the SCS system are shown by way of example.

[0051] Figure 7 Embodiments of data and control flow in a system utilizing machine learning to optimize neural stimulation patterns are illustrated by way of example.

[0052] Figure 8 Embodiments of data and control flow in the system are shown by way of example.

[0053] Fig. 9 Another embodiment of the data and control flow in the system is shown by way of example.

[0054] Fig.10 An embodiment of a system providing IPG control is shown by way of example.

[0055] Fig.11 An embodiment of a method for controlling an IPG is shown by way of example.

[0056] Fig.12 is a block diagram illustrating a machine in the example form of a computer system within which a set or sequence of instructions may be executed, causing the machine to perform any of the methodologies discussed herein, according to an example embodiment. DETAILED DESCRIPTION

[0057] The following detailed description of this theme refers to the accompanying drawings, which illustrate by way of illustration specific aspects and embodiments in which this theme can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice this theme. Other embodiments may be utilized and structural, logical, and electronic changes may be made without departing from the scope of this theme. References to "one," "one," or "each" embodiment in this disclosure are not necessary for the same embodiment, and such references predict more than one embodiment. Therefore, the following detailed description should not be construed as limiting, and the scope is defined only by the full scope of the attached claims and the legal equivalents authorized by these claims.

[0058] Various embodiments described herein relate to spinal cord modulation.A brief description of the physiology of the spinal cord and related apparatus is provided herein to aid the reader. Figure 1 A portion of a spinal cord 100 including white matter 101 and gray matter 102 of the spinal cord is shown by way of example. The gray matter 102 includes cell bodies, synapses, dendrites, and axon terminals. Thus, synapses are located in the gray matter. The white matter 101 includes myelinated axons that connect gray matter regions. A typical cross section of the spinal cord includes a central "butterfly" shaped central region of the gray matter 102 that is substantially surrounded by an elliptical outer region of the white matter 101. The white matter of the dorsal column (DC) 103 primarily includes larger myelinated axons that form afferent fibers that extend axially. The dorsal portion of the "butterfly" shaped central region of the gray matter is referred to as the dorsal horn (DH) 104. Contrary to the DC fibers that extend axially, the DH fibers can be oriented in many directions, including perpendicular to the longitudinal axis of the spinal cord. An example of a spinal nerve 105 is also shown, including a dorsal root (DR) 105, a dorsal root ganglion 107, and a ventral root 108. The dorsal root 105 mostly carries sensory signals into the spinal cord, and the ventral root serves as an efferent motor root. The dorsal and ventral roots combine to form the mixed spinal nerve 105.

[0059] SCS has been used to relieve pain. Figure 1As shown, the therapeutic goal of conventional SCS programming is to maximize the stimulation of DC fibers extending along the longitudinal axis of the spinal cord in the white matter (i.e., recruitment) and minimize the stimulation of other fibers (mainly dorsal root fibers) extending perpendicular to the longitudinal axis of the spinal cord. The white matter of DC mainly includes large myelinated axons that form afferent fibers. Although the complete mechanism of pain relief is not well understood, it is believed that the perception of pain signals is inhibited via the gated control theory of pain, which indicates that the enhanced activity of harmless touch or pressure input via electrical stimulation produces interneuronal activity in the DH of the spinal cord that releases inhibitory neurotransmitters (gamma aminobutyric acid (GABA), glycine), which in turn reduces the hypersensitivity of wide dynamic range (WDR) sensory neurons to the harmful afferent input of pain signals propagated from the dorsal root (DR) nerve fibers that dominate the patient's pain area, and treats general WDR ectopia. Therefore, the larger sensory input of DC nerve fibers has been targeted with stimulation of the amplitude that provides pain relief. Current implantable neuromodulation systems typically include electrodes implanted adjacent to the dorsal columns of a patient's spinal cord (ie, resting near or on the dura mater) and along the longitudinal axis of the patient's spinal cord.

[0060] Activation of larger sensory DC nerve fibers also typically produces paresthesia sensations that often accompany standard SCS treatment. Some embodiments deliver treatments in which the delivery of energy is perceptible due to sensations such as paresthesias. Although alternative or artificial sensations (e.g., paresthesias) are generally tolerated relative to the sensation of pain, patients sometimes report that these sensations are uncomfortable, and therefore in some cases, they can be considered as adverse side effects for neuromodulation treatments. For example, some embodiments deliver subperceptual treatments that are effective in treating pain therapeutically, but the patient does not feel the delivery of the modulation field (e.g., paresthesias). Subperceptual treatments can include higher frequency modulations (e.g., about 1500 Hz or higher) of the spinal cord that effectively block the transmission of pain signals in the afferent fibers in the DC. Some embodiments herein selectively modulate DH tissue or DR tissue on DC tissue to provide subperceptual treatments. For example, selective modulation can be delivered at a frequency of less than 1200 Hz. In some embodiments, selective modulation can be delivered at a frequency of less than 1000 Hz. In some embodiments, selective modulation can be delivered at a frequency of less than 500 Hz. In some embodiments, selective modulation can be delivered at a frequency of less than 350 Hz. In some embodiments, selective modulation can be delivered at a frequency of less than 130 Hz. Selective modulation can be delivered at low frequencies (e.g., as low as 2 Hz). Selective modulation can be delivered even without pulses (e.g., 0 Hz) to modulate some neural tissue. By way of example and not limitation, selective modulation can be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1200 Hz; 2 Hz to 1000 Hz; 2 Hz to 500 Hz; 2 Hz to 350 Hz; or 2 Hz to 130 Hz. Systems can be developed to raise the lower end of any of these ranges from 2 Hz to other frequencies, such as, by way of example and not limitation, 10 Hz, 20 Hz, 50 Hz, or 100 Hz. By way of example and not limitation, it should also be noted that selective modulation can be delivered in a duty cycle, where stimulation (e.g., a pulse train) is delivered during the stimulation ON portion of the duty cycle, and no stimulation is delivered during the stimulation OFF portion of the duty cycle. By way of example and not limitation, the duty cycle can be approximately 10% ± 5%, 20% ± 5%, 30% ± 5%, 40% ± 5%, 50% ± 5%, or 60% ± 5%. For example, a 10 ms burst of pulses during the ON portion of stimulation followed by 15 ms of no pulses corresponds to a 40% duty cycle.

[0061] Figure 2An embodiment of a neuromodulation system is shown. The system 210 shown includes an electrode 211, a modulation device 212, and a programming device 213. The electrode 211 is configured to be placed on or near one or more neural targets in a patient. The modulation device 212 is configured to be electrically connected to the electrode 211 and deliver neuromodulation energy (e.g., in the form of electrical pulses) to one or more neural targets through the electrode 211. The delivery of neuromodulation is controlled by using multiple modulation parameters (e.g., modulation parameters that specify the selection of electrical pulses and electrodes through which each electrical pulse is delivered). In various embodiments, at least some of the multiple modulation parameters are programmable by a user such as a physician or other caregiver. The programming device 213 provides accessibility to user-programmable parameters to the user. In various embodiments, the programming device 213 is configured to be communicatively coupled to the modulation device via a wired link or a wireless link. In various embodiments, the programming device 213 includes a graphical user interface (GUI) 214 that allows a user to set and / or adjust the values ​​of the user-programmable modulation parameters.

[0062] Figure 3 It is shown that, for example, Figure 2 Embodiments of a modulation device 312 implemented in a neuromodulation system 210 of the present invention. The embodiment of the modulation device 312 shown includes a modulation output circuit 315 and a modulation control circuit 316. It will be understood by those skilled in the art that the neuromodulation system 210 may include additional components, such as sensing circuits, telemetry circuits, and power supplies for feedback control of patient monitoring and / or treatment. The modulation output circuit 315 generates and delivers neuromodulation pulses. The modulation control circuit 316 uses multiple modulation parameters to control the delivery of neuromodulation pulses. The lead system 317 includes: one or more leads, each of which is configured to be electrically connected to the modulation device 312; and a plurality of electrodes 311-1 to 311-N, which are distributed in an electrode arrangement using one or more leads. Each lead may have an electrode array including two or more electrodes (which may also be referred to as contacts). Multiple leads may provide multiple electrode arrays to provide an electrode arrangement. Each electrode is a single conductive contact that provides an electrical interface between the modulation output circuit 315 and the patient's tissue, where N≥2. Each slave modulation output circuit 315 delivers neuromodulation pulses through a set of electrodes selected from electrodes 311-1 to 311-N. The number of leads and the number of electrodes on each lead may depend, for example, on the distribution of one or more targets of neuromodulation and the need to control the distribution of the electric field at each target. In one embodiment, by way of example and not limitation, the lead system includes two leads each having eight electrodes.

[0063] The neuromodulation system can be configured to modulate spinal cord target tissue or other neural tissue. The configuration of electrodes for delivering electrical pulses to targeted tissues constitutes an electrode configuration, wherein the electrodes can be selectively programmed to be used as anodes (positive), cathodes (negative) or not (zero). In other words, the electrode configuration represents polarity as positive, negative or zero. Other parameters that can be controlled or changed include the amplitude, pulse width and rate (or frequency) of the electrical pulses. Each electrode configuration together with the electrical pulse parameters can be referred to as a "modulation parameter set". Each modulation parameter set including a fractional current distribution (as a percentage cathode current, a percentage anode current or disconnection) of the electrodes can be stored and combined into a modulation program that can be used to modulate multiple areas in the patient later.

[0064] The number of available electrodes, combined with the ability to generate a variety of complex electrical pulses, presents a clinician or patient with a large selection of available modulation parameter sets. For example, if the neuromodulation system to be programmed has sixteen electrodes, millions of modulation parameter sets may be available for programming into the neuromodulation system. In addition, for example, the SCS system may have thirty-two electrodes that exponentially increase the number of modulation parameter sets available for programming. To facilitate such selection, clinicians typically program modulation parameter sets through a computerized programming system to allow for determination of optimal modulation parameters based on patient feedback or other means and then programming the desired modulation parameter set. A closed-loop mechanism may be used to identify and test modulation parameter sets, receive patient or clinician feedback, and further revise the modulation parameter sets in an attempt to optimize the stimulation paradigms to reduce pain. Patient or clinician feedback may be an objective and / or subjective measure reflecting pain, paresthesia coverage, or other aspects of patient satisfaction with stimulation.

[0065] Figure 4 An embodiment of a programming device 413 is shown. The programming device 413 may be implemented as Figure 2 The programming device 213 in the neural modulation system of the present invention. The programming device 413 includes a storage device 418, a programming control circuit 419 and a GUI 414. The programming control circuit 419 generates a plurality of modulation parameters that control the delivery of neural modulation pulses based on the pattern of neural modulation pulses. In various embodiments, the GUI 414 includes any type of presentation device, such as an interactive or non-interactive screen and any type of user input device that allows a user to program the modulation parameters, such as a touch screen, a keyboard, a keypad, a touchpad, a trackball, a joystick, and a mouse. Among other things, the storage device 418 can store modulation parameters to be programmed into the modulation device. The programming device 413 can send a plurality of modulation parameters to the modulation device. In some embodiments, the programming device 413 can send a plurality of modulation parameters to the modulation device (e.g., Figure 3The modulation device 312 of the present invention sends power. The programming control circuit 419 can generate multiple modulation parameters. In various embodiments, the programming control circuit 419 can check the values ​​of the multiple modulation parameters against the security rules to limit the values ​​within the constraints of the security rules.

[0066] In various embodiments, circuits for neuromodulation including various embodiments thereof discussed in this document may be implemented using a combination of hardware, software, and firmware. For example, circuits for GUI 414, modulation control circuit 316, and programming control circuit 419 including various embodiments thereof discussed in this document may be implemented using dedicated circuits configured to perform one or more specific functions or general purpose circuits programmed to perform one or more such functions. Such general purpose circuits include, but are not limited to, microprocessors or portions thereof, microcontrollers or portions thereof, and programmable logic circuits or portions thereof.

[0067] Figure 5 Portions of an implantable neuromodulation system and an environment in which the system can be used are shown by way of example. The system is shown for implantation near the spinal cord. However, the neuromodulation system can be configured to modulate other neural targets. System 520 includes an implantable system 521, an external system 522, and a telemetry link 523 that provides wireless communication between the implantable system 521 and the external system 522. Implantable system 521 is shown to be implanted in a patient. Implantable system 521 includes an implantable modulation device (also referred to as an implantable pulse generator or IPG) 512, a lead system 517, and electrodes 511. Lead system 517 includes: one or more leads, each of which is configured to be electrically connected to a modulation device 512; and a plurality of electrodes 511, which are distributed in one or more leads. In various embodiments, external system 402 includes one or more external (non-implantable) devices, each of which allows a user (e.g., a clinician or other caregiver and / or patient) to communicate with implantable system 521. In some embodiments, the external system 522 includes a programming device intended for a clinician or other caregiver to initialize and adjust settings for the implantable system 521 and a remote control device intended for use by the patient. For example, the remote control device can allow the patient to turn therapy on and off and / or adjust certain patient-programmable parameters of a plurality of modulation parameters. The remote control device can also provide a mechanism to provide the patient with feedback on the operation of the implantable neuromodulation system. The feedback can be a metric reflecting perceived pain, therapeutic effectiveness, or other aspects of patient comfort or condition.

[0068] One or more neuromodulation leads of the lead system 517 can be placed adjacent to the spinal cord region to be stimulated (i.e., against or on the dura mater). For example, one or more neuromodulation leads can be implanted along the longitudinal axis of the patient's spinal cord. Due to the lack of space near the location where one or more neuromodulation leads exit the spine, the implantable modulation device 512 can be implanted in a surgical pocket in the abdomen or on the buttocks, or can be implanted in other locations of the patient's body. One or more lead extensions can be used to facilitate implantation of the implantable modulation device 512 away from the exit point of the one or more neuromodulation leads.

[0069] Figure 6 An embodiment of an SCS system 600 is shown by way of example. The SCS system 600 generally includes a plurality of neuromodulation leads 12 (in this case, two percutaneous leads 12a and 12b), an implantable pulse generator (IPG) 14, an external remote control (RC) 16, a clinician's programmer (CP) 18, an external trial stimulator (ETS) 20, and an external charger 22.

[0070] The IPG 14 is physically connected to the neurostimulation lead 12 via two lead extensions 24, and the neurostimulation lead 12 carries a plurality of electrodes 26 arranged in an array. In the illustrated embodiment, the neurostimulation lead 12 is a percutaneous lead, and for this purpose, the electrodes 26 can be coaxially arranged along the neurostimulation lead 12. Although any suitable number (including only one) of neurostimulation leads 12 can be provided, the number of neurostimulation leads 12 shown is two. Alternatively, a surgical paddle lead can be used to replace one or more of the percutaneous leads. As will be described in more detail below, the IPG 14 includes a pulse generation circuit that delivers electrical stimulation energy to the electrode array 26 in the form of a pulsed electrical waveform (i.e., a time series of electrical pulses) according to a set of stimulation parameters. The IPG 14 and the neurostimulation lead 12 can be configured as an implantable neurostimulation kit, together with, for example, a hollow needle, a stylet, a tunneling tool, and a tunneling straw.

[0071] The ETS 20 may also be physically connected to the neurostimulation lead 12 via a percutaneous lead extension 28 or an external cable 30. The ETS 20, which has pulse generation circuitry similar to the IPG 14, also delivers electrical stimulation energy to the electrode array 26 in the form of a pulsed electrical waveform according to a set of stimulation parameters. The primary difference between the ETS 20 and the IPG 14 is that the ETS 20 is a non-implantable device that is used experimentally to test responsiveness to the stimulation to be provided after the neurostimulation lead 12 is implanted and before the IPG 14 is implanted. Therefore, any functionality described herein with respect to the IPG 14 may be performed similarly with respect to the ETS 20.

[0072] The RC 16 can be used to remotely control the ETM 20 via the two-way RF communication link 32. Once the IPG 14 and stimulation leads 12 are implanted, the RC 16 can be used to remotely control the IPG 14 via the two-way RF communication link 34. This control allows the IPG 14 to be turned on or off and programmed with different stimulation programs after implantation. Once the IPG 14 has been programmed and its power source is charged or otherwise replenished, the IPG 14 can operate as programmed without the presence of the RC 16.

[0073] The CP 18 provides detailed stimulation parameters to the user for programming the IPG 14 and ETS 20 in the operating room and in subsequent sessions. The CP 18 may perform this function by communicating indirectly with the IPG 14 or ETS 20 through the RC 16 via an IR communication link 36. Alternatively, the CP 18 may communicate directly with the IPG 14 or ETS 20 via an RF communication link (not shown).

[0074] External charger 22 is a portable device used to transcutaneously charge IPG 14 via inductive link 38. Once IPG 14 is programmed and its power source is charged or otherwise replenished by external charger 22, IPG 14 may operate as programmed without RC 16 or CP 18 present.

[0075] For the purposes of this specification, the terms "neurostimulator," "stimulator," "neurostimulation," and "stimulation" generally refer to the delivery of electrical energy that affects neuronal activity of neural tissue, which can be excitatory or inhibitory; for example, by initiating action potentials, inhibiting or blocking the transmission of action potentials, affecting changes in neurotransmitter / neuromodulator release or uptake, and inducing changes in neuroplasticity or neurogenesis of tissue. For the sake of brevity, the details of RC 16, ETS 20, and external charger 22 are not described herein.

[0076] Manage programming services on the programmer

[0077] For many patients, neurostimulation therapy is an effective option for managing chronic pain. Chronic pain is rarely static. Instead, pain typically migrates and changes affect different parts of the patient's body to varying degrees. Thus, as the patient's pain changes, the neurostimulation programming that is most effective in blocking or masking the pain also changes. Typically, the patient's stimulation programming is performed by a clinician or technician. As patients become more familiar with the technology and as the technology advances, patients can be in a better position to modulate the stimulation programming based on their perceived pain.

[0078] The present disclosure describes several workflows, systems, methods, and devices that provide improvements to patients, physicians, insurance companies, and medical device manufacturers to help better manage pain and provide better patient support. For example, patients are provided with tools that allow them to better manage their pain and reduce office visits, thereby reducing their out-of-pocket costs. Physicians are able to review, approve, and communicate with their patients remotely, thereby increasing their daily patient throughput, better managing patient care, and increasing revenue. Insurance companies are provided with a way to easily integrate new patient care models into existing systems. Medical device manufacturers and representatives are able to provide patients with additional products and services to help with product support and pain management.

[0079] Figure 7 An embodiment of an operating environment 700 is shown by way of example. Environment 700 includes a user device 702, a management device 704, and a server 706, all of which are connected via a network 708. User device 702 and management device 704 may be any type of computing device, including but not limited to a tablet computer, a desktop computer, a hybrid computer, a laptop computer, a wearable device (e.g., smart glasses or smart watches), a smart phone, a personal digital assistant (PDA), a handheld personal computer, etc. Server 706 may be one or more computers (e.g., in a server farm or cloud environment) that provide a consistent action of a virtualized server environment. Server 706 may be a conventional server system that provides a service that listens on one or more active ports and processes requests received at these ports. Server 706 may act in response to a specific application on user device 702 or management device 704. Communications from the user device 702 or management device 704 to the server 706 may be encrypted or otherwise protected using one or more security mechanisms such as a public key infrastructure (PKI) scheme (e.g., Diffie-Hellman key exchange, RSA algorithm, etc.) or a symmetric key exchange (e.g., Data Encryption Standard (DES), Advanced Encryption Standard (AES), etc.).

[0080] The network 708 may include a local area network (LAN), a wide area network (WAN), a wireless network (e.g., 802.11 or cellular network), a public switched telephone network (PSTN) network, an ad hoc network, a personal area network (e.g., Bluetooth), or other combinations or arrangements of network protocols and network types. The network 708 may include a single local area network (LAN) or wide area network (WAN), or a combination of LANs or WANs (such as the Internet). The various devices coupled to the network 708 may be coupled to the network 708 via one or more wired or wireless connections.

[0081] Applications have become mainstream commodities. Applications are provided for various computing platforms, including tablets, desktops, smartphones, etc. Applications can be provided for certain operating systems, such as or Android TM , or may be universal for all popular operating systems. Applications may be made available to users from an online repository (e.g., an app store). An online repository may provide applications that have been checked and screened by the repository.

[0082] The patient may install an application on user device 702 to control the IPG or correspond with a person at management device 704. Management device 704 may be used by several different types of people including, but not limited to, physicians, clinicians, specialists, sales representatives, insurance representatives, customer support representatives, and the like.

[0083] In operation, the patient can use the user device 702 to program, query or maintain the IPG. In this way, in various embodiments, the user device 702 acts as a CP, ETS or RC. The user device 702 can display stimulation parameters, programs, event history and other aspects of programming or controlling the IPG. The patient can determine that a specific programming routine is not effective in suppressing or masking pain, and can decide to evaluate a new program. The patient can input a request via the user device 702 to obtain a new program. The request is sent to the management device 704 via the network 708.

[0084] Upon receiving the request, the physician (or similar personnel) can review the patient's files and approve the request. The approval can be sent from the management device 704 to the user device 702 via the network 708. The approval can include additional instructions for the patient, which can be displayed on the user device 702. After approval, a new procedure can be started in the IPG using a wireless connection from the user device 702 to the IPG. Alternatively, the user device 702 can be used to direct the CP, ETC, or RC to interact with the IPG to program the IPG.

[0085] Due to the number of available electrodes combined with the ability to generate a variety of complex electrical pulses, a large selection of available modulation parameter sets can be available to clinicians or patients for programming. For example, if the neuromodulation system to be programmed has sixteen electrodes, millions of modulation parameter sets can be used to program into the neuromodulation system. In addition, for example, the SCS system can have thirty-two electrodes that exponentially increase the number of modulation parameter sets available for programming. In order to facilitate such selection, clinicians usually program modulation parameter sets through a computerized programming system to allow the optimal modulation parameters to be determined based on patient feedback or other means and then program the desired modulation parameter set. A closed-loop mechanism can be used to identify and test modulation parameter sets, receive patient or clinician feedback, and further revise the modulation parameter sets to try to optimize the stimulation paradigms to reduce pain. Patient or clinician feedback can be an objective and / or subjective measure reflecting pain, paresthesia coverage, or other aspects of patient satisfaction with stimulation. Therefore, the patient can use this loop multiple times to request a change in programming from the physician through the user device 702 to the management device 704 path.

[0086] The best modality can be identified during a trial or after permanent implantation using software or hardware in an implantable pulse generator (IPG), a programming device, or a patient remote control. The stimulation pattern can be modulated in both the time domain and the spatial domain. The stimulation pattern can also be modulated in the information domain referring to the pulse pattern. The learning system can automatically cycle through different sub-perceptual modalities (e.g., high frequency, burst, medium-low frequency / low amplitude, etc.), collect patient feedback through a remote control or other system for each of the modalities, and associate patient feedback with treatment effects to determine the best or improved treatment. This allows for improved or optimal sub-perceptual treatment to be determined without interacting with a health care provider or manufacturer's representative.

[0087] An initial set of stimulation patterns may be generated from a domain of all available stimulation patterns. The initial set may be obtained using one or more machine learning or optimization algorithms to search and identify effective patterns. Alternatively, the initial set may be provided by a clinician.

[0088] In addition to the initial set of parameter sets, one or more ranges for one or more parameters can be determined by the system or provided by a user (e.g., a clinician). The ranges can be for various aspects, including amplitude, pulse width, frequency, pulse pattern (e.g., predetermined or parameterized), cycle on / off characteristics, spatial location of the field, spatial extent of the field, etc.

[0089] The estimated time for wash-in and wash-out can be provided by the user or determined by the system. In an embodiment, the system estimates the wash-in / wash-out to be used based on the patient's feedback. Accurately estimating the wash-in / wash-out is important because overestimation (e.g., time is too long) may cause unnecessary pain to the patient because the programming cycle is too slow, and underestimation (e.g., time is too short) may cause missing important information because the wash-in has not yet occurred. Therefore, in one embodiment, the user is able to set the expected number of wash-ins / wash-outs for use by the learning machine algorithm. Alternatively, IPG programming can start with a user estimate, and then make adjustments based on data collected from the user or other sources to modify the estimated number of washes or washes.

[0090] In a clinical system, one or more stimulation patterns can be provided to a patient, and the one or more stimulation patterns can be tested by the patient with or without clinician supervision. Objective pain metrics, subjective pain metrics, or both objective and subjective pain metrics can be received from the patient, which are used in machine learning or optimization algorithms to develop further pattern sets. Objective pain metrics include those metrics such as EEG activity, heart rate, heart rate variability, galvanic skin response, etc. that are expressed physiologically. Subjective pain metrics can be provided by the patient and expressed, for example, as "severe pain", "low pain" or a digital range. Various communication mechanisms such as wireless networks, tethered communications, short-range telemetry, or a combination of these mechanisms can be used to transmit pain metrics. Patients can manually enter some information (e.g., subjective pain scores).

[0091] A non-exhaustive list of pain metrics is provided here. An example of a pain metric is EEG activity (e.g., theta activity in the somatosensory cortex and alpha and gamma activity in the prefrontal cortex have been shown to be associated with pain). Another example pain metric is fMRI (activity in the anterior cingulate cortex and insula has been shown to be associated with changes in chronic pain). Another example pain metric is fMRI (activity in the pain matrix, which is composed of the thalamus, primary somatosensory cortex, anterior cingulate cortex, prefrontal cortex, and cerebellum and is activated under pain conditions). Another example pain metric is heart rate variability, galvanic skin response, cortisol levels, and other measures of autonomic system function (autonomic system health has been shown to be associated with pain). Another example pain metric is physical activity (the amount of physical activity has been shown to be associated with pain). Another example pain metric is a pain score (which can be entered through an interface in which the patient selects points on a visual analog scale or clicks on numbers on a digital rating scale). Another example pain measure is a quantitative sensory test [e.g., spatial discrimination (two point, location, diameter), temporal discrimination, detection threshold (mechanical, thermal, electrical), pain threshold (mechanical, thermal, electrical), temporal summation, heat grill] (QST measures have been shown to correlate with pain). Another example pain measure is somatosensory evoked potentials, contact heat evoked potentials (these have been shown to correlate with pain). Another example pain measure is the H reflex, nociceptive flexion reflex (these have been shown to be reduced by SCS). Another example pain measure is conditioned place preference (e.g., in one chamber, stimulated with one paradigm 1, in another chamber, stimulated with paradigm 2. The chamber in which the animal spends the most time wins and proceeds to the next round). Another example pain measure is local field potential recordings in the pain matrix (in preclinical models, recordings of neural activity in these areas may be done with invasive electrodes).

[0092] Some pain measures are primarily preclinical in nature (e.g., conditioned place preference and local field potential recordings), while others are primarily clinical in nature (e.g., pain scores and quantitative sensory testing). However, it should be understood that pain measures can be obtained in either preclinical or clinical settings.

[0093] Pain metrics can be continuously or repeatedly collected from patients and injected into machine learning or optimization algorithms to improve or change stimulation parameters. For example, patients can interact with programmers, remote controls, bedside monitors, or other patient devices to record physiological conditions, pain, medication dosages, etc. Patient devices can be connected to a system with a machine learning system by wire or wirelessly. This closed-loop mechanism provides the advantage of reducing the search domain during repeated iterations of machine learning or optimization algorithms. By reducing the search domain, clinicians are able to identify effective patterns more quickly, and patients can undergo shorter programming sessions, which produces less discomfort.

[0094] In addition to pain metrics, additional patient feedback may be obtained, such as satisfaction ratings, self-reported activity, visual analog scales (VAS), or numerical rating scales (NRS). Other feedback and outputs may be obtained, such as from a user (eg, a clinician) or sensor values.

[0095] The physical system can take many different forms. Data collected from the patient can be measured using wearable sensors (e.g., heart rate monitors, accelerometers, EEG headsets, pulse oximeters, GPS / location trackers, etc.). Pain metrics and other feedback involving manual input can be input via a remote control or other external device used by the patient (e.g., via user device 702).

[0096] Figure 8 An embodiment of data and control flow in the system is shown by example. A user 800 (e.g., a patient) can install an application on a user device. The application can be installed with standard or baseline options and features. While using the application, the user 800 is notified of additional features or a new version of the application (operation 802). For example, after a trial period, the user 800 is provided with an opportunity to unlock additional features that were not initially exposed to the user 800. These features can be advanced features for users with more experience with the application. As another example, the user 800 can be presented with an opportunity to add additional features based on a pay-per-feature model. The user 800 can pay for the feature using an in-app purchase model, wherein the user indicates that he wants to install or unlock new features, and the application can prompt the user to confirm, after which the application can use a lower-level payment system to process the in-app purchase. The payment system can have a credit card or other form of payment from the user 800's record, which is then debited for the amount of the in-app purchase. Payment can be a copay or coinsurance to cover the patient portion of the expense.

[0097] As a specific example, an application with basic functionality of program selection, enabling or disabling stimulation, and amplitude control may be provided to user 800. Additional features may be made available to user 800, such as the ability to store several programs, the ability to automatically rotate through programs, control over finer adjustments to programs, etc. These additional features may be built into the initial installation of the application (option 804), or provided as ongoing upgrades or improvements from the creator of the application (option 806).

[0098] When the user 800 decides to upgrade or unlock features of the application, 800 can send a request to a physician 808. The physician 808 can decide to allow the user 800 to access the additional features based on various factors, such as the user's mental condition or ability, the user's emotional state, the user's physical condition, etc. The physician 808 can approve or deny the user's request. If the physician 808 denies the request, at operation 810, the user 800 is notified of the denial, with an optional note from the physician 808 indicating the reason for the denial of the request.

[0099] If the physician 808 approves the request for the new feature or new version of the application, a control message is sent back to the user's device to unlock or install the new feature. Payment of co-payments or co-insurance, if any, may be processed at this time. Additionally, upon approval by the physician 808, an invoice is generated and sent to the insurance company 810 (operation 812). The insurance company 810 may then perform conventional settlement processes, such as by paying the physician's office or physician 808, paying the application developer or application owner 814, providing an explanation of the benefits statement to the user 800, and the like.

[0100] exist Figure 8 Under the workflow shown, insurance costs are reduced because no in-person patient visit is required, physicians can be compensated for their time based on the opportunity for more revenue from shorter interactions, and application developers / owners are compensated based on usage by the userbase.

[0101] Fig. 9 Another embodiment of data and control flow in the system is shown by example. User 900 is adapted with an implantable medical device (IMD). In an example, the implantable medical device can be an implantable neurostimulation system, and can include an implantable neurostimulator also referred to as an implantable pulse generator (IPG), and one or more implantable leads each including one or more electrodes. The implantable neurostimulator delivers neurostimulation energy by one or more electrodes placed on or near a target site in the nervous system. An external programming device is used to program the implantable neurostimulator using stimulation parameters that control the delivery of neurostimulation energy. User 900 can use a user device (e.g., user device 702) as an external programming device.

[0102] When user 900 experiences changes in his daily pain, he may decide to change the programming of his IMD. User 900 requests a change from sales representative 902 (operation 904). Sales representative 902 may act as a technical liaison with physician 906 and assist user 900 in selecting programming that is effective for user 900. In this way, sales representative 902 may adjust programming (operation 908), and user 900 (e.g., patient) may test the program in a short time period (e.g., 5 minutes). User interface controls may be provided to a person (e.g., user 900, sales representative 902, or physician 906) to set the test cycle of the program, manage the internal wash / external wash time, provide a user report (e.g., table, graph, summary) with raw data or compiled data, or control the alternating program. For example, the "Best So Far" (BSF) program may be used or repeated over time to ensure that the patient experiences a good proportion of effective stimulation. The BSF program may be used every other program, every three programs, or otherwise to allow the system to test additional programs between the BSF programs.

[0103] The user 900 may evaluate the reprogramming (operation 910). If the user 900 rejects the reprogramming, the user 900 may interact with the sales representative 902 to request another program change (operation 904) and repeat the test subsequent reprogramming. When the user 900 is satisfied with the reprogramming, the user 900 may communicate with the physician 906 to request approval of the programming, thereby making the programming the active programming of the user 900.

[0104] Physician 906 can evaluate the proposed reprogramming in light of the user's medical history and other factors and approve the reprogramming, reject the reprogramming, or approve the reprogramming with changes.

[0105] If the physician 906 approves the changes, the flow returns to the interaction between the user 900 and the sales representative 902, where the sales representative 902 can make changes to the program (operation 908) and the user 900 can again evaluate the programming with the changes provided by the physician. If the physician 906 denies the request for reprogramming, the user 900 can be notified of the reason via the user device.

[0106] If the physician 906 approves the reprogramming, several operations occur. An invoice to the insurance company 912 may be automatically generated based on the approval (operation 914). The insurance company 912 may then perform conventional settlement operations to reimburse the physician, request a co-payment or co-insurance from the user 900, and provide an explanation of the benefit statement to the user 900. Additionally, based on the physician's approval of the reprogramming, a control message is provided to the user's user device. The control message may be used by the user device to allow the user 900 or the sales representative 902 to activate the programming, replacing the previous program.

[0107] It should be understood that the program may include multiple programs, and the IPG may be configured to run with one or more of these identified programs for a period of time until the next re-optimization and reconfiguration. Ideally, during this period of time, the patient has the best program available at the time. However, the patient may experience some neurological adjustments in which the patient's neurological system becomes accustomed to the program in a way that the program loses some of its effect on the patient. The result may be that the patient experiences more pain or different pain as days or weeks pass. In order to avoid this neurological adjustment, a rotating or changing program schedule may be provided to the patient. This changing program schedule can provide neuroplasticity in the patient's neurological system; keep the patient's neurological system confused, and improve the performance or life of the program's efficacy. This programming reduces the need for reprogramming, thereby reducing the power consumption of the equipment in the neuromodulation system and improving the quality of life of the patient.

[0108] Thus, in an embodiment, two or more programs may be cycled on the IPG. The programs may change regularly (e.g., every seven days) or irregularly (e.g., randomly changing within a five to seven day range). When cycling more than two programs, the order of the programs may be regular (e.g., sequential cycling) or irregular (e.g., random cycling).

[0109] In an example, a burst waveform may run for a specific time period before the system automatically transitions to a high rate waveform, which cycles between programs. To avoid a period in which pain relief and / or therapeutic effects from a first waveform (A) ends before the therapeutic effects of the next waveform (B) begin, waveform B may be initiated before waveform A terminates.

[0110] Fig.10 An embodiment of a system 1000 providing IPG control is shown by way of example. The system 1000 may take one of a variety of forms. The system 1000 may be a remote control or other external device, such as a user device 702, used by a patient or clinician.

[0111] System 1000 includes a processor subsystem 1002 and a memory 1004. Processor subsystem 1002 may be any single processor or a group of processors working in concert. Memory 1004 may be any type of memory, including volatile or non-volatile memory. Memory 1004 may include instructions that, when executed by processor subsystem 1002, cause processor subsystem 1002 to receive a request to modify an application at an application executed on a user device, send the request to a management user device for approval, receive a response to the request from the management user device, and modify the functionality of the application in response to receiving the response.

[0112] In one embodiment, the request to modify the application includes a request to add a new feature to the application.

[0113] In one embodiment, the response is provided by a physician using an administrative user device.

[0114] In one embodiment, the instructions may include instructions to connect to the application repository to obtain a different version of the application after receiving a response to the request. In such an embodiment, modifying the functionality of the application includes installing a different version of the application to replace the application. For example, the application developer may periodically or regularly release a new version of the application. For a user who wants to install the application, the user may need to obtain the approval of a physician first. In such an embodiment, modifying the functionality of the application in response to receiving the response includes enabling new features in the application. For example, the new feature may be enabled by installing a plug-in, unlocking a previously locked feature, or downloading a new version of the application.

[0115] In an embodiment, the request to modify the application includes a request to modify the stimulation parameters of the implantable pulse generator. In such an embodiment, modifying the functionality of the application in response to receiving the approval includes updating the application to program the implantable pulse generator with the stimulation parameters. The application can be configured to allow the user to test the new programming routine for testing, but in order to implement the new programming routine for semi-permanent use, the user may first need approval from their physician.

[0116] In an embodiment, the request to modify the application to modify the stimulation parameters is made after an evaluation period. The evaluation period allows the user to test different stimulation parameters to determine which is most effective for them at that point in time. Therefore, the evaluation period includes interacting with a technician to systematically test various stimulation parameters. The technician can be a physician, clinician, expert, device manufacturer representative, etc.

[0117] In an embodiment, the response to the request is approval of the change, and the memory 1004 includes instructions that, when executed by the processor subsystem 1002, cause the processor subsystem to adjust the stimulation parameters for additional evaluation based on the approval of the change.

[0118] In an embodiment, the memory 1004 includes instructions that, when executed by the processor subsystem 1002, cause the processor subsystem 1002 to resubmit the request for approval after the adjustment of the stimulation parameters.

[0119] In an embodiment, the response to the request is a denial of the request, and wherein the memory 1004 includes instructions that, when executed by the processor subsystem 1002, cause the processor subsystem 1002 to present a notification on the user device that includes a reason why the request was denied.

[0120] In an embodiment, the user device comprises a smartphone.

[0121] Fig.11 An embodiment of a method 1100 for controlling an IPG is shown by way of example. At 1102, a request to modify an application is received at an application executing on a user device. In an embodiment, the request to modify the application includes a request to add a new feature to the application.

[0122] At 1104, the request is sent to the administrative user device for approval.

[0123] At 1106, a response to the request is received from an administrative user device (eg, user device 702). In an embodiment, the response is provided by a physician using the administrative user device.

[0124] At 1108, the functionality of the application is modified in response to receiving the response.

[0125] In an embodiment, the method 1100 includes connecting to an application repository to obtain a different version of the application after receiving a response to the request, and in such an embodiment, modifying the functionality of the application includes installing the different version of the application in place of the application.

[0126] In an embodiment, modifying the functionality of the application in response to receiving the response includes enabling a new feature in the application.

[0127] In an embodiment, the request to modify the application comprises a request to modify stimulation parameters of the implantable pulse generator. In another embodiment, modifying the functionality of the application in response to receiving the approval comprises updating the application to program the implantable pulse generator with the stimulation parameters.

[0128] In an embodiment, the request to modify the application to modify the stimulation parameters is made after the evaluation period. In another embodiment, the evaluation period includes interacting with a technician to systematically test various stimulation parameters.

[0129] In an embodiment, the response to the request is approval of the change, and in such an embodiment, the method 1100 includes modulating the stimulation parameters based on the approval of the change for additional evaluation. In another embodiment, the method 1100 includes resubmitting the request for approval after adjusting the stimulation parameters.

[0130] In an embodiment, the response to the request is a denial of the request, and in such an embodiment, method 1100 includes presenting a notification on the user device including a reason why the request was denied.

[0131] Embodiments may be implemented in one or a combination of hardware, firmware, and software. Embodiments may also be implemented as instructions stored on a machine-readable storage device, which may be read and executed by at least one processor to perform the operations described herein. A machine-readable storage device may include any non-transitory mechanism for storing information in a machine (e.g., computer) readable form. For example, a machine-readable storage device may include a read-only memory (ROM), a random access memory (RAM), a magnetic disk storage medium, an optical storage medium, a flash memory device, and other storage devices and media.

[0132] The processor subsystem can be used to execute instructions on a machine-readable medium. The processor subsystem may include one or more processors, each processor having one or more cores. In addition, the processor subsystem may be arranged on one or more physical devices. The processor subsystem may include one or more special-purpose processors, such as a graphics processing unit (GPU), a digital signal processor (DSP), a field programmable gate array (FPGA), or a fixed-function processor.

[0133] Fig.12 It is a block diagram of a machine shown in the example form of a computer system 1200 according to an example embodiment, in which a group or series of instructions can be executed in the machine to cause the machine to perform any of the methods discussed herein. In an alternative embodiment, the machine operates as a standalone device or can be connected (e.g., networked) to other machines. In a networked deployment, the machine can operate with the duties of a server or client machine in a server-client network environment, or it can act as a peer machine in a peer-to-peer (or distributed) network environment. The machine can be a personal computer (PC), a tablet computer, a hybrid tablet computer, a personal digital assistant (PDA), a mobile phone, an implantable pulse generator (IPG), an external remote control (RC), a clinician programmer (CP), an external test stimulator (ETS) or any machine capable of executing instructions (continuous or otherwise) specifying the action to be taken by the machine. In addition, although only a single machine is shown, the term "machine" should also be understood to include a collection of any machines, which execute one or more instruction sets individually or jointly to perform any one or more of the methods discussed herein. Similarly, the term "processor-based system" shall be understood to include any collection of one or more machines controlled or operated by a processor (e.g., computers) to individually or jointly execute instructions to perform any one or more of the methodologies discussed herein.

[0134] The example computer system 1200 includes at least one processor 1202 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both, a processor core, a computing node, etc.), a main memory 1204, and a static memory 1206, which communicate with each other via a link 1208 (e.g., a bus). The computer system 1200 may further include a video display unit 1210, an alphanumeric input device 1212 (e.g., a keyboard), and a user interface (UI) navigation device 1214 (e.g., a mouse). In one embodiment, the video display unit 1210, the input device 1212, and the UI navigation device 1214 are incorporated into a touch screen display. The computer system 1200 may additionally include a storage device 1216 (e.g., a drive unit), a signal generating device 1218 (e.g., a speaker), a network interface device 1220, and one or more sensors (not shown) such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensors.

[0135] The storage device 1216 includes a machine-readable medium 1222 on which is stored one or more data structure sets and instruction sets 1224 (e.g., software) embodying or utilized by any one or more of the methodologies or functions described herein. The instructions 1224 may also reside, completely or at least partially, within the main memory 1204, the static memory 1206, and / or within the processor 1202 during execution thereof by the computer system 1200, with the main memory 1204, the static memory 1206, and the processor 1202 also constituting machine-readable media.

[0136] Although the machine-readable medium 1222 is shown as a single medium in the example embodiment, the term "machine-readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) storing one or more instructions 1224. The term "machine-readable medium" should also be considered to include any tangible medium that can store, encode, or carry instructions that are executed by a machine and cause the machine to perform any one or more of the methods of the present disclosure, or that can store, encode, or carry data structures utilized by or associated with such instructions. The term "machine-readable medium" should therefore be considered to include, but is not limited to, solid-state memory and optical and magnetic media. Specific examples of machine-readable media include non-volatile memory, which by way of example includes, but is not limited to, semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0137] The instructions 1224 may further be sent or received via the network interface device 1220 using a transmission medium over a communication network 1226 using one of many well-known transmission protocols (e.g., HTTP). Examples of communication networks include a local area network (LAN), a wide area network (WAN), the Internet, a mobile phone network, a plain old telephone (POTS) network, and a wireless data network (e.g., Wi-Fi, 3G, and 4G LTE / LTE-A or WiMAX networks). The term "transmission medium" shall be deemed to include any intangible medium that is capable of storing, encoding, or carrying instructions to be executed by the machine and includes digital or analog communication signals, or other intangible media for facilitating the communication of such software.

[0138] The foregoing detailed description is intended to be illustrative rather than limiting. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. A method implemented using a system having a user device, a management device and an implantable medical device, wherein: The implantable medical device is configured for implantation in a patient, can be configured with a program schedule of at least two neuromodulation programs for providing at least two neuromodulation therapies, and the implantable medical device is configured to implement the program schedule to cycle through the at least two neuromodulation programs periodically or irregularly, and in a regular sequence or an irregular sequence, wherein the management device is configured for use by an administrator, and wherein the user device is configured to execute an application and is configured for use by the patient to communicate with the management device and the implantable medical device, the method comprising: receiving, at the application executing on the user device, a request to modify a programming schedule; sending the request to the management device for approval; receiving a response to the request from the management device, wherein the response is provided by the administrator using the management device; and In response to receiving the response, the application is modified by changing programming.

2. The method according to claim 1, wherein: The administrator includes a physician, specialist, sales representative, insurance representative, or customer support representative.

3. The method according to claim 1, wherein: The request to modify the programming schedule includes a request to replace one or more neuromodulation programs in the programming schedule.

4. The method according to claim 1, wherein: The request to modify the programming schedule includes a request to add one or more neuromodulation programs to the programming schedule.

5. The method according to claim 1, wherein: The request to modify the programming schedule includes a request to change a timing of cycling through the at least two neuromodulation programs in the programming schedule.

6. The method according to claim 1, wherein: The request to modify the programming schedule includes a request to change an order of cycling through the at least two neuromodulation programs in the programming schedule.

7. The method according to claim 1, wherein: The request to modify the procedure schedule includes a request to modify a duration of at least one of the at least two neuromodulation procedures.

8. The method according to claim 1, wherein: The changing of program arrangement includes changing the internal washing time or external washing time for switching between programs.

9. The method according to claim 1, wherein: The altering of the scheduling includes using a pain metric from the patient to alter the scheduling.

10. The method according to claim 1, wherein: The changing the scheduling includes using machine learning and pain metrics from the patient to change the scheduling.

11. The method according to claim 1, wherein: The receiving of the request to modify the program schedule includes receiving an indication to include the one of the at least two programs that is considered the best along with at least one other program in the modified program schedule for further evaluation.

12. The method according to claim 1, wherein: The request to modify the programming schedule includes a request to transition from an evaluation period to a permanent programming schedule for cycling through at least two neuromodulation programs.

13. The method according to claim 1, wherein: The implantable medical device is configured to sequentially cycle through the at least two neuromodulation programs in a predetermined order.

14. The method of claim 1, further comprising receiving, at the application executing on the user device, a request for a report corresponding to a procedure schedule and pain metrics, wherein the report comprises a graph, a table, or a summary.

15. A method implemented using a system having a user device, a management device, and an implantable medical device, wherein: The implantable medical device is configured for implantation in a patient, can be configured with a program schedule of at least two neuromodulation programs for providing at least two neuromodulation therapies, and the implantable medical device is configured to implement the program schedule to cycle through the at least two neuromodulation programs periodically or irregularly, and in a regular sequence or an irregular sequence, wherein the management device is configured for use by an administrator, and wherein the user device is configured to execute an application and is configured for use by the patient to communicate with the management device and the implantable medical device, the method comprising: receiving pain measures from the patient; receiving, at the application executing on the user device, a request to change at least one of two programs in a program arrangement; sending the request to the management device for approval; receiving a response to the request from the management device, wherein the response is provided by the administrator using the management device; and In response to receiving the response, the application is modified by changing the programming schedule in accordance with the request, including using machine learning and pain metrics from the patient to change the programming schedule.

16. The method of claim 15, further comprising receiving, at the application executing on the user device, a request for a report corresponding to a procedure schedule and pain metrics, wherein the report comprises a graph, a table, or a summary.

17. The method according to claim 16, wherein: The receiving of the request to modify the program schedule includes receiving an indication to include the one of the at least two programs that is considered the best along with at least one other program in the modified program schedule for further evaluation.

18. A method implemented using a system having a user device, a management device, and an implantable medical device, wherein: The implantable medical device is configured for implantation in a patient, can be configured with a program schedule of at least two neuromodulation programs for providing at least two neuromodulation therapies, and the implantable medical device is configured to implement the program schedule to cycle through the at least two neuromodulation programs periodically or irregularly, and in a regular sequence or an irregular sequence, wherein the management device is configured for use by an administrator, and wherein the user device is configured to execute an application and is configured for use by the patient to communicate with the management device and the implantable medical device, the method comprising: receiving pain measures from the patient; receiving, at the application executing on the user device, a request to change timing of cycling through the at least two neuromodulation programs in a programming schedule; sending the request to the management device for approval; receiving a response to the request from the management device, wherein the response is provided by the administrator using the management device; and In response to receiving the response, modifying the application by changing the programming schedule in accordance with the request, including using machine learning and pain metrics from the patient to change the timing of cycling through the at least two neuromodulation programs in the programming schedule.

19. The method of claim 18, wherein the request to change timing comprises a request to modify a duration of at least one of the at least two neuromodulation procedures.

20. The method of claim 18, wherein the request to change timing includes changing an in-wash time or an out-wash time for transitioning between programs.

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