Device and Method for Improved Remote Programming of an Implanted Nerve Stimulation System

Abstract

Methods, devices, and systems for facilitating remote programming of an implanted nerve stimulation system. Establish communication between an implanted pulse generator (IPG) and a remote programming device associated with a remote support entity via one or more relay devices capable of utilizing various communication protocols such as Bluetooth (BT), MedRadio (MR), cellular, WiFi, or any combination thereof. The relay device can communicate directly with a Bluetooth-enabled IPG and the remote programming device, or can utilize additional relay devices such as a patient recon, adapter accessory, etc., to include patient devices that can facilitate communication with an existing BT-noncompliant IPG. The patient device and the remote device can further include a software framework for collecting subjective / objective patient information and facilitating communication between the IPG and the remote support entity. The system can further include a web-based portal accessible by the patient device and the remote device to further notify of remote programming or self-programming.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit and priority of U.S. Provisional Application No. 63 / 338,403, which is hereby incorporated by reference in its entirety.

[0002] This application is generally related to U.S. Patent Application No. 17 / 513,790, filed on October 28, 2021, with the title "Devices and Methods for Remote Programming of Implanted Neurostimulation Systems"; U.S. Patent Application No. 16 / 871,738, filed on May 11, 2020, with the title "Attachment Devices and Associated Methods of Use With a Nerve Stimulation Charging Device"; U.S. Patent Application No. 14 / 827,067, filed on August 14, 2015, with the title "Systems and Methods for Neurostimulation Electrode Configurations Based on Neural Localization" (U.S. Patent No. 9,855,423); U.S. Patent Application No. 14 / 992,777, filed on January 11, 2016, with the title "Patient Remote and Associated Methods of Use With a Nerve Stimulation System" (U.S. Patent No. 9,895,546); and U.S. Patent Application No. 14 / 993,009, filed on January 11, 2016, with the title "Improved Antenna and Methods of Use For an Implantable Nerve Stimulator" (U.S. Patent No. 9,700,731), each of which is assigned to the same assignee and is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0003] This application relates to remote programming of a nerve stimulation therapy system, as well as related devices, methods, and system setups.

[0004] Treatment with implantable nerve stimulation systems has become increasingly common in recent years. Although such systems have been shown to be promising for the treatment of multiple conditions, the effectiveness of treatment can vary widely among patients. Patient outcomes can vary widely due to multiple factors, and it may be difficult to determine the feasibility of treatment prior to implantation. Current stimulation electrode placement / implantation techniques, and known treatment programming techniques, have significant drawbacks. The nerve tissue structures of different patients can vary widely, and it is difficult to accurately predict or identify the location and branching of nerves that perform a specific function and / or deactivate a specific organ. The electrical properties of the tissue structures surrounding the target nerve structure can also vary widely among different patients, the nerve responses to stimulation can vary significantly, and the pattern, pulse width, frequency, and / or amplitude of electrical stimulation pulses that are effective in affecting a patient's body function may cause significant discomfort or pain, or only limited effects, in another patient. Even in patients for whom implantation of a nerve stimulation system provides effective treatment, frequent adjustments and changes to the stimulation protocol are often required until an appropriate treatment program can be determined, and repeated clinic visits and significant discomfort are often associated with the patient until effectiveness is achieved. More recently developed systems have improved the efficiency of lead placement and stimulation and improved treatment consistency, but many patients still occasionally require adjustments or changes to the treatment program. Such reprogramming often requires direct clinic visits and sometimes repeated clinic visits. Implanted nerve stimulation systems communicate with accessory components within the system using dedicated local communication (e.g., MedRadio), and considering that patients lack the expertise or permission to adjust or modify the therapy, this represents a significant barrier to programming the implanted system without the need for in-person visits by a clinician or system technician. The design of current therapy systems is simply not suitable for remote control or programming.These problems pose a significant obstacle to maintaining long-term effective treatment for patients living in remote areas, or for patients belonging to patient groups who are elderly, young, or in a socially vulnerable position.

[0005] Accordingly, it would be desirable to provide an improved system, device, and method by which an implanted nerve stimulation system can be adjusted or reprogrammed remotely by a clinician or technical expert without the need for an in-person examination. It would be further beneficial for such a method to facilitate communication between the patient and the clinician and still enable remote programming of the system while providing the benefits of an in-person examination.

Summary of the Invention

Means for Solving the Problems

[0006] This application generally relates to remote programming of nerve stimulation treatment systems, and related devices and methods. This application is particularly applicable to a sacral nerve stimulation treatment system configured to treat bladder-bowel related disorders. However, it will be understood by those skilled in the art that the various exemplary embodiments disclosed herein can also be utilized for the treatment of pain, or other symptoms such as movement disorders or mood disorders, or for various other implanted medical devices.

[0007] The disclosed embodiments relate to a method, user device, relay communication device, and dedicated application software for facilitating remote programming of embedded objects by a remote device. As described above, there is an increasing need for remote programming of embedded medical devices, which enables medical personnel to remotely communicate with a patient via a phone or tablet device and reprogram or troubleshoot a medical device embedded in the patient's body. By using a dedicated relay communication device that utilizes various types of communication (e.g., Bluetooth (BT), MedRadio (MR), cellular / Wifi, or any combination thereof), and a dedicated software application, a user can establish a live communication session for programming their embedded devices or troubleshoot their devices remotely in a convenient, safe, and reassuring manner for all parties involved. In some exemplary embodiments, the user can utilize a custom device and / or accessory device to streamline system setup and / or provide additional functionality beyond the capabilities of existing devices or personal devices. Additionally, the present application discloses various options and system setups that can be adapted to various available IPG designs (charged and uncharged) with various communication capabilities. In some exemplary embodiments, the remote programming setup system is designed to be backward compatible with existing devices / systems (BT-incompatible IPGs). In other embodiments, the system setup is designed to be forward compatible with next-generation remote programming capabilities (e.g., an IPG or patient remote control designed to have both MR and BT capabilities).In yet other aspects, the system setup may include a patient database portal, by which therapy information may be periodically updated, and the system setup can notify remote programming by a remote device or self-programming by a patient device. The patient portal can be web-based and hosted on a secure server and can be accessed by a patient device or a remote programming device. In other aspects, the remote programming system setup described herein can be incorporated into a telemedicine platform (e.g., Teledoc, VSee, Doxy.me, OhMD, Whereby, Mend, Updox, NextGen, Healthcare EHR, etc.). Generally, a telemedicine platform includes a technical infrastructure, services, and support that enable high-quality virtual medical consultations and treatments remotely, which are private, secure, and HIPAA-compliant. Such a telemedicine system may typically include telephone, video conferencing, or text-based communication, often using a patient's personal device, via a remote communication system. Accordingly, the remote programming functionality described herein can be incorporated into these telemedicine platforms to utilize the existing functionality of these platforms for the purpose of remote programming.

[0008] Typical, implanted medical devices communicate with their peripheral devices (e.g., clinician programmers, patient remote controls, etc.) via specific frequencies dedicated for medical device use, such as the MedRadio (Medical Device Radio communications Service) bands (e.g., the ranges of 401 - 406 MHz, 413 - 419 MHz, 426 - 432 MHz, 438 - 444 MHz, and 451 - 457 MHz). Additionally, MBANs (Medical Body Area Networks) are low - power networks of sensors worn on the body, controlled by a hub device placed on or near the body, and operate in the 2360 - 2400 MHz band. Standard smartphones or tablets are not suitable for communicating with or programming implanted medical devices. A live communication session can be established remotely between an implanted medical device, a patient device, and a remote device by using a dedicated relay device or an update to an existing accessory device, enabling programming.

[0009] The relay device can communicate with an implanted medical device via the MedRadio band on the one hand, and with a patient's phone or tablet device, which is either an iOS device or an Android device, via Bluetooth or Bluetooth Low Energy on the other hand. In some exemplary embodiments, the system utilizes an existing accessory such as a patient remote or a charger as the relay device. In some exemplary embodiments, a dedicated relay device can be configured to plug into a user's device (e.g., smartphone, tablet, laptop) via its charging port or other port (e.g., USB-C, USB, etc.). Then, the relay device can be powered and recognized by the user's phone or tablet device. A dedicated application (the "app") can be developed and pre-downloaded onto the user's device. The user can be a patient, a clinician, or a patient supporter. This app can be used to change the program settings of the implanted device or to troubleshoot by instructing the implanted device to perform a diagnosis on itself and report to the user device. In other embodiments, the dedicated device can be a separate device that communicates with a patient device such as a smartphone or tablet via wireless communication, e.g., Bluetooth or Near Field Communication ("NFC"), and communicates with the implanted device via MedRadio. In this embodiment, the relay device has a built-in power supply and is self-powered. As described above, a specific app can be developed and pre-downloaded onto the user's device to enable changes to the program settings or troubleshooting of the implanted device.

[0010] A method for remotely programming an implanted nerve stimulation system is disclosed herein. The method includes receiving, by a remote device, a patient request for programming of an implantable pulse generator of a nerve stimulation system implanted in a patient; establishing a communication session between the implantable pulse generator of the nerve stimulation system, the remote device associated with a remote support entity, via one or more relay local devices; receiving, by the remote device, program information and patient information; determining or receiving, by the remote device, a program update regarding an update of one or more parameters of a current program or a new program applied by the implanted nerve stimulation system; and programming the implantable pulse generator, by the remote device, via one or more relay devices, using the program update. In some exemplary embodiments, the program information includes a current therapy program applied by the implanted nerve stimulation system. In some exemplary embodiments, the patient information includes patient identification information, objective information, and / or subjective information regarding the treatment. The objective information may include, but is not limited to, any of the number of voids, the volume of each void, the number of pads, a VAS (Visual Analogue Scale) pain score, a QoL (Quality of Life) score, sleep duration, and current stimulation therapy parameters. The subjective information may include, but is not limited to, anything the patient is feeling, a change in mood, and the quality of sleep.

[0011] In some exemplary embodiments, one or more relay local devices include any of a charger device, a patient remote device, a patient's personal computing device, and a specialized dedicated communication device. In some exemplary embodiments, one or more relay devices include a first relay device and a second relay device, the first relay device communicating with an implantable pulse generator and the second relay device, and the second relay device communicating with the first relay device and a remote device of a remote support entity. In some exemplary embodiments, the first relay device is any of a charger, a patient remote device, a dedicated communication device, and a plug-in accessory to a patient's personal computing device. The first relay device communicates with the implantable pulse generator by a first communication scheme (e.g., MedRadio). The second relay device communicates with the first relay device by a second communication scheme (e.g., Bluetooth) and may communicate with the remote device by other communication schemes (e.g., Wi-Fi, cellular, wired connection, or any combination thereof).

[0012] In some exemplary embodiments, the second relay device includes a dedicated patient app specially configured to facilitate programming. The patient app can be configured to access or store program information and communicate with a remote device for programming. In some exemplary embodiments, the patient app can be configured to access program information from a data center associated with the first party developer of the implantable pulse generator. In some exemplary embodiments, the patient app can be configured to access program information from the implantable pulse generator via the first relay device. In some exemplary embodiments, the patient app is further configured to receive, via a user interface, current therapy programs and / or patient input regarding patient information. The patient app can further include a bladder diary and / or voiding log that stores subjective information regarding the effectiveness of the current therapy program and can be accessed by a remote entity during programming. The subjective information can be collected and / or recorded within the patient app at least over multiple days on a regular basis. In some exemplary embodiments, the patient app is configured to conduct a live communication session, such as a live video call, between the patient and a remote device of a remote support entity. Communication between the remote device and one or more local relay devices can utilize any of a cloud-based server, a local server of the remote entity, or a hosted server hosted by a third party. In some exemplary embodiments, the remote entity is associated with the first party developer of the implantable pulse generator and / or the dedicated patient app on one or more local relay devices. In some exemplary embodiments, the remote entity is a third party that is a technical consultant, a treating physician, a clinician, or a staff member of a healthcare provider.In some exemplary embodiments, the patient app may be configured to be installed on a user's personal portable computing device and may not be accessible by an Internet browser.

[0013] In other aspects, the remote device may include a dedicated remote programming app that operates on the remote device. The remote programming app may be provided to an Internet browser and configured to be accessed by the remote device. The remote device can be any of a smartphone, a tablet, a laptop, or a desktop computing device. In some exemplary embodiments, the remote programming app may be configured for installation and access on a portable computing device associated with a treating clinician or a related healthcare provider. In some exemplary embodiments, the remote programming app may be configured to establish communication with a patient via a backend associated with the first-party developer of the implantable pulse generator. The communication session may include access to patient information and / or program information from a data center associated with the first-party developer of the implantable pulse generator, which is accessed via the backend. In some exemplary embodiments, the backend is a cloud-based, first-party local server, or a hosted server. In some exemplary embodiments, the initial communication is established in response to a remote entity or a related entity receiving a request for programming initiated by the patient using a second relay device. In some exemplary embodiments, establishing communication includes exchanging identification information regarding the implantable pulse generator, the patient, and the remote entity between the second relay device and the remote device, and ensuring secure authenticated communication during the session. In some exemplary embodiments, the remote device can perform management control of the implantable pulse generator during at least a portion of the communication session beyond the patient communication session.In some exemplary embodiments, the method includes accessing, by a remote device, a plurality of recommended nerve stimulation programs, including a current therapy program, and selecting, by the remote device, one of the plurality of recommended nerve stimulation programs for application as a new updated program. The plurality of recommended nerve stimulation programs are stored either in an implantable pulse generator or in a separate data center and can be accessed by the remote device using patient information.

[0014] A method for remotely programming an implanted nerve stimulation system using a patient device is disclosed herein. The method includes establishing, by the patient device, a communication session with a remote device associated with a remote support entity, transmitting, by the patient device, patient information and / or program information regarding a current therapy program applied by an implantable pulse generator of the implanted nerve stimulation system to the remote device, receiving, by the patient device, a program update from the remote device regarding an update of one or more parameters of the current program or a new program, and outputting, by the patient device, the program update to the implanted nerve stimulation system, thereby programming the implantable pulse generator using the program update of one or more parameters of the current program or the new program from the remote device via the patient device.

[0015] Disclosed herein are various methods for remotely programming an implanted nerve stimulation system by a remote device. The method includes establishing a communication session between an implantable pulse generator of the nerve stimulation system implanted in a patient and a remote device associated with a remote support entity via one or more relay local devices for programming and / or reprogramming of the implantable pulse generator by the remote entity; receiving program information by the remote device, the program information including a current treatment program on the implanted nerve stimulation system; receiving patient information regarding the current treatment program by the remote device via one or more local relay devices, the patient information including patient identification information and / or subjective information regarding the therapy; determining or receiving by the remote device a program update regarding an update of one or more parameters of the current program or a new program for the implanted nerve stimulation system based on a current based on the therapy program information and the patient information; and programming the implantable pulse generator by the remote device using the program update via one or more relay devices.

[0016] Systems for remotely programming an implanted nerve stimulation system are also disclosed. The system can include an implantable pulse generator, a first relay device, a second relay device, and a remote device of a remote support entity. The implantable pulse generator of the nerve stimulation system is implanted in a patient and includes one or more antennas for wireless communication with one or more external devices by a first communication. The first relay device can be configured to communicate with the implantable pulse generator and one or more additional devices by a local communication. The second relay device is associated with the patient and can be configured to communicate with the first relay device by a local communication and with one or more additional devices by a remote communication. The second relay device includes a user interface for receiving patient input from the patient. The remote device associated with the remote support entity can be configured to communicate with the second relay device by a remote communication, and the remote device includes a user interface for receiving input from the remote support entity. In some exemplary embodiments, the system can be configured to establish, via a first relay local device and a second relay local device, a communication session between the implantable pulse generator of the nerve stimulation system and the remote device, through which program information and / or patient information is received by the remote device for programming and / or reprogramming of the implantable pulse generator by a remote entity.

[0017] Embodiments of a patient device configured to facilitate remote programming of an implanted nerve stimulation system are disclosed herein. The patient device may include a portable housing, a communication module, a user interface, and a processor module disposed within the housing. The communication module includes one or more antennas including a remote communication antenna for communicating with one or more remote devices via a network, and a local communication antenna for communicating locally with one or more relay devices and / or an implantable pulse generator. The processor module is a processor module having a processor and a memory, and computer-executable instructions configured for programming of the implantable pulse generator via the patient device by a remote device are stored on the memory. In some exemplary embodiments, the patient device may be a portable computing device such as a laptop or smartphone, or a dedicated device, and may include a dedicated patient app for facilitating programming according to any of the aspects described herein.

[0018] Further fields of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not necessarily intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0019]

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[0020] The disclosed embodiments relate to remote programming of an implanted nerve stimulation therapy system and related devices that facilitate such remote programming. Certain embodiments relate to a sacral nerve stimulation therapy system configured to treat bladder dysfunction, including overactive bladder ("OAB"), and relieve associated symptoms, in addition to bowel dysfunction. For ease of explanation, embodiments may be described in their use for OAB; however, it will be understood by those skilled in the art that the disclosed embodiments may be utilized for any of a variety of neuromodulation applications, such as bowel disorders (e.g., fecal incontinence, frequent bowel movements, urgency, and / or constipation), pain, or treatment of other indications such as movement disorders or mood disorders.

[0021] I. Nerve Stimulation Indications A nerve stimulation (or neuromodulation, hereinafter used interchangeably) therapy system, such as any of the nerve stimulation therapy systems described herein, can be used to treat various diseases and related symptoms, such as acute pain disorders, movement disorders, and mood disorders, in addition to bladder-related dysfunction and bowel dysfunction. Examples of pain disorders that can be treated by nerve stimulation include post-spinal surgery pain syndrome, reflex sympathetic dystrophy or complex regional pain syndrome, causalgia, arachnoiditis, and peripheral neuropathy. Movement disorders include paralysis, tremors, dystonia, and Parkinson's disease. Mood disorders include depression, obsessive-compulsive disorder, cluster headache, Tourette's disorder, and certain types of chronic pain. Bladder-related dysfunction includes, but is not limited to, OAB, urge incontinence, urgency-frequency, and urinary retention. OAB can include urge incontinence and urgency-frequency, alone or in combination. Urge incontinence is incontinence associated with a sudden strong urge to urinate (urgency). Urgency-frequency is a frequent, often uncontrollable, urge to urinate (urgency) that often results in very small amounts of urination (frequency). Urinary retention is a condition in which the bladder cannot be emptied. Nerve stimulation therapy can be configured to address specific symptoms by providing nerve stimulation of target nerve tissue related to sensory control and / or motor control related to that symptom or related symptoms. Bowel disorders can include any of various inflammatory, motility, and incontinence symptoms.

[0022] In one aspect, the methods and systems described herein are particularly suitable for the treatment of voiding and defecation dysfunction. These symptoms have historically not been well recognized by the medical community and the provision of medical services by the medical community has been significantly inadequate. OAB is one of the most common voiding dysfunctions. This is a complex symptom characterized by the presence of bothersome voiding symptoms, including urinary urgency, frequency, nocturia, and urge incontinence. It is estimated that approximately 40 million Americans are troubled by OAB. Approximately 16% of the adult population, both male and female, suffer from OAB symptoms.

[0023] OAB symptoms can have a significant negative impact on a patient's psychosocial function and quality of life. People with OAB often limit their activities and / or develop coping strategies. Additionally, OAB places a significant financial burden on the individual, their family, and healthcare institutions. The prevalence of comorbidities is also significantly higher in patients with OAB than in the general population. Comorbidities can include falls and fractures, urinary tract infections, skin infections, vulvovaginitis, cardiovascular disease, and central nervous system pathology. Chronic constipation, fecal incontinence, and recurrent chronic constipation occur more frequently in patients with OAB.

[0024] II. Sacral Neuromodulation SNM is an established therapy that provides a safe, effective, reversible, and long-lasting treatment option for the management of urge urinary incontinence, urgency-frequency, and non-obstructive urinary retention. SNM therapy involves the use of weak electrical pulses to stimulate the sacral nerves located in the lower back. Electrodes are typically placed adjacent to the sacral nerves at the S3 level by inserting an electrode lead into the corresponding foramen of the sacrum. The electrodes are inserted subcutaneously and subsequently attached to an implantable pulse generator (IPG). The safety and efficacy of SNM for the treatment of OAB, including durability at 5 years, have been supported and well-documented in multiple studies for patients with both urge urinary incontinence and urgency-frequency. SNM is also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapies.

[0025] A. Implantation of the Sacral Neuromodulation System Currently, SNM identification has a test phase, and if successful, permanent implantation is then performed. The test phase is a test stimulation period during which the patient can evaluate whether the therapy is effective. Generally, there are two techniques used to perform the test stimulation. One is an outpatient-based procedure called Percutaneous Nerve Evaluation (PNE), and the other is a staged test.

[0026] In PNE, generally, a spinal needle is first used to identify the optimal stimulation position, usually at the S3 level, and to evaluate the integrity of the sacral nerves. Motor and sensory responses are used to verify correct needle placement. Subsequently, a temporary stimulation lead (unipolar electrode) is placed near the sacral nerves under local anesthesia. This procedure can be performed in a clinical setting without fluoroscopy. Subsequently, the temporary lead is connected to an external pulse generator (EPG) that is taped to the patient's skin during the test phase. The stimulation level can be adjusted to provide the optimal comfort level for a particular patient. The patient will monitor his or her urination over a period of 3 to 7 days to see if there is any improvement in symptoms. The advantage of PNE is that it is a non-invasive procedure that can be performed in a clinical setting using local anesthesia. If the patient fails this trial test, the physician may still recommend a staged test as described below. If the PNE test is positive, the temporary test lead is removed and a permanent quadripolar tined lead is implanted with the IPG under general anesthesia.

[0027] The staged trial initially involves the implantation of a permanent quadripolar tined stimulation lead into the patient. This also requires the use of a stylet to identify the nerve and the optimal stimulation location. The lead is implanted near the S3 sacral nerve and connected to the EPG via a lead extension. This procedure is performed in the operating room under fluoroscopic guidance and under local or general anesthesia. The EPG is adjusted to provide an optimal comfort level for the patient, and the patient monitors his or her urination for up to two weeks. If the patient experiences a significant improvement in symptoms, he or she is considered a suitable candidate for permanent implantation of the IPG in the upper buttock region, generally as shown in Figure 3, under general anesthesia.

[0028] Regarding the measurement of outcomes for SNM treatment of urinary dysfunction, urinary dysfunction indications (e.g., urge incontinence, urge-frequency, and non-obstructive urinary retention) can be evaluated by unique primary voiding diary variables. Treatment outcomes are measured using these same variables. SNM treatment is considered successful if there is at least a 50% improvement compared to baseline in any of the primary voiding diary variables. For patients with urge incontinence, these voiding diary variables may include the number of urinary leakage episodes per day, the number of large-volume urinary leakage episodes per day, and the number of pads used per day. For patients with urge-frequency, the primary voiding diary variables may include the number of voids per day, the volume voided per void, and the degree of urge experienced prior to each void. For patients with urinary retention, the primary voiding diary variables may include the volume catheterized per catheterization and the number of catheterizations per day. For patients with fecal incontinence, the outcome measurements captured by the voiding diary include the number of fecal leakage episodes per week, the number of days with fecal leakage per week, and the degree of fecal urgency experienced prior to each fecal leakage.

[0029] The disclosed embodiments relate to remote programming of a nerve stimulation system adapted to deliver nerve stimulation to a target nerve tissue to cause partial or complete activation of target nerve fibers and potentially enhance or inhibit nerve activity within the nerve that controls organs and structures associated with bladder function and bowel function, which may be the same as or different from the stimulation target.

[0030] B. Nerve Stimulation Lead Implantation and Programming Nerve stimulation relies on consistently delivering therapeutic stimulation from a pulse generator, through one or more nerve stimulation electrodes, to a specific nerve or target area. The nerve stimulation electrodes are disposed on the distal end of an implantable lead that can be advanced through a tunnel formed within patient tissue. Implantable nerve stimulation systems provide the patient with a high degree of freedom and mobility, but it may be easier to adjust the nerve stimulation electrodes of such a system before they are surgically implanted. It is desirable for the physician to confirm that the patient is exhibiting the desired motor response and / or sensory response before implanting the IPG. For at least some treatments (including treatment of at least some forms of urinary and / or fecal incontinence), demonstrating an appropriate motor response can be very beneficial for accurate and objective lead implantation while a sensory response may not be required or may not be obtainable (e.g., the patient is under general anesthesia).

[0031] Placement and calibration of nerve stimulation electrodes and implantable leads in sufficient proximity to a specific nerve can be beneficial for the effectiveness of treatment. Accordingly, aspects and embodiments of the present disclosure are directed to assisting and refining the accuracy and precision of nerve stimulation electrode placement. Further, aspects and embodiments of the present disclosure are directed to assisting and refining protocols for setting therapeutic treatment signal parameters for stimulation programs implemented via implanted nerve stimulation electrodes.

[0032] In an exemplary embodiment, determination of whether the implantable lead and nerve stimulation electrode are located in the desired or correct position can be achieved by utilizing the neuromuscular response to a test stimulation, such as the observed response, or through the use of electromyography ("EMG"), also known as surface electromyography. EMG is a technique that uses an EMG system or module to evaluate and record the electrical activity generated by muscles and produces a record called an electromyogram. EMG detects the potentials generated by muscle cells when these cells are electrically or neurologically activated. The signals can be analyzed to detect the activation level or recruitment order. EMG can be performed through electrodes placed on the patient's skin surface, within the muscle, or in the vicinity of the target muscle inside the patient, or by using a combination of external and internal structures. When a muscle or nerve is stimulated by an electrode, EMG can be used to determine whether the associated muscle is activated in response to the stimulation (i.e., whether the muscle contracts fully, partially, or not at all). Thus, the degree of muscle activation can indicate whether the implantable lead or nerve stimulation electrode is located in the desired or correct position on the patient. Additionally, the degree of muscle activation can indicate whether the nerve stimulation electrode is providing stimulation of sufficient intensity, amplitude, frequency, or duration to affect the treatment regimen for the patient. Therefore, the use of EMG provides an objective and quantitative means by which to standardize the placement of implantable leads and nerve stimulation electrodes and reduce the subjective assessment of patient sensory responses. Although the use of EMG responses is discussed in some of the exemplary programming methods described below, it is understood that the concept of remote programming described herein is applicable to any type of programming approach, including programming approaches that do not utilize EMG.

[0033] C. System Embodiments FIG. 1 schematically illustrates an exemplary nerve stimulation system setup that includes a setup for use in a test nerve stimulation system 200 and a setup for use in a permanently implanted nerve stimulation system 100. EPG 80 and IPG 50 are a clinical medical programming device (CP) 60 and a patient remote device 70, respectively, that are compatible and communicate wirelessly with the clinical medical programming device 60 and the patient remote device 70 used in the positioning and / or programming of the test nerve stimulation system 200 and / or the permanently implanted system 100 after a test is successful. As described above, the system utilizes a cable set and an EMG sensor patch within the test system setup 100 to facilitate lead placement and nerve stimulation programming. The CP may include dedicated software, dedicated hardware, and / or both to assist with lead placement, programming, reprogramming, stimulation control, and / or parameter setting. Additionally, each of the IPG and EPG enables the patient to at least partially control the stimulation (e.g., start a pre-set program, increase or decrease the stimulation) and / or monitor the battery status via the patient remote device. This approach also enables a nearly seamless transition between the test system and the permanent system. The CP may be used by a clinician during the initial programming of the EPG and IPG or remotely during a communication session with the remote support 90 during subsequent remote programming of the IPG. The system may include one or more relay devices to facilitate a communication session between the remote support and the IPG in addition to the patient. The one or more relay devices may include the patient device 80 and may further utilize accessory devices such as the charger 50, the patient remote device 70, or the reprogramming communicator 75 to enable communication between the patient device 80 and the IPG.

[0034] CP60 is used by a physician to adjust the settings of the EPG and / or the IPG during initial programming while the lead is implanted within the patient. The CP can be a tablet computer that is used by a clinician to program the IPG during a test period or to control the EPG. The CP can also include the ability to record stimulus-evoked electromyograms and facilitate lead placement and programming. The patient remote device 70 can enable the patient to turn the stimulus on or off or change the stimulus from the IPG while implanted or from the EPG during a test phase. CP60 has a control unit that can include a microprocessor and dedicated computer code instructions for implementing the methods and systems used by a physician when deploying the treatment system and setting the treatment parameters. The CP generally includes a graphical user interface for facilitating clinician input for programming. The CP can include a module having hardware and computer code for performing EMG analysis, and this module can be a component of the control unit microprocessor or a preprocessing unit coupled or in-line with the stimulation cable and / or the sensory cable, etc.

[0035] In other aspects, the CP60 enables a clinician to read the impedance of each electrode contact at any time when the lead is connected to the EPG, IPG, or CP, a secure connection is made, and it is ensured that the lead is intact. This can be used during lead positioning and in lead programming to ensure that the electrodes are functioning properly. The CP60 can also be useful for storing and displaying previous (e.g., up to the last four) programs used by the patient and facilitating reprogramming. Alternatively, the most recent programs can be stored on the IPG, on the patient device, or in the patient's profile and can be stored in a data center accessible by the patient device and / or the CP. In some exemplary embodiments, the CP60 further includes a USB port for storing reports on a USB drive and a charging port. The CP can be configured to operate in combination with the EPG when implanting the lead inside the patient's body and to operate in combination with the IPG during programming. The CP can be electrically coupled to the EPG during test simulations via a dedicated cable set or via wireless communication, thereby enabling the CP to configure, modify, or otherwise program the electrodes on the lead connected to the EPG. The CP includes a physical or virtual on / off button and can turn the CP on / off and / or turn the stimulation on / off.

[0036] Figures 2A-2C show diagrams of the nerve structures of various patients that can be used in nerve stimulation therapy. Figure 2A shows different segments of the spinal cord and the corresponding nerves within each segment. The spinal cord is a long, thin bundle of nerves that supports cells extending from the brainstem, along the cervical spinal cord, through the thoracic spinal cord, to the space between the first and second lumbar vertebrae within the lumbar spinal cord. When emerging from the spinal cord, the nerve fibers split into multiple branches that stimulate various muscles and organs and transmit sensory and control impulses between the brain, organs, and muscles. Since a nerve can include branches that innervate an organ such as the bladder and branches that stimulate certain muscles of the legs and feet, stimulation of the nerve roots near the spinal cord or the nerves in its vicinity can stimulate the nerve branches that stimulate the target organ, which can also result in muscle reactions associated with the stimulation of other nerve branches. Thus, a physician can determine whether the target nerve is being stimulated by visually monitoring a muscle reaction, or through the use of EMG described herein, or both. Although a certain level of stimulation can induce a robust muscle reaction visible to the naked eye, lower levels of stimulation (e.g., sub-threshold) can still provide activation of the nerves associated with the target organ without inducing the corresponding muscle reaction or inducing only a reaction that is not visible without the use of EMG. In some exemplary embodiments, this low-level stimulation does not cause any paresthesia. This is advantageous because it allows for treating symptoms by nerve stimulation without the discomfort, pain, or unwanted muscle reactions in the patient that are caused by other methods.

[0037] Figure 2B shows the lower lumbar region, within the lower lumbar region, of nerves related to the lower back where nerve bundles exit the spinal cord and proceed through the sacral foramina of the sacrum. In some exemplary embodiments, a nerve stimulation lead is advanced through the foramen until the nerve stimulation electrodes are positioned on the anterior sacral nerve root, while the anchor portion of the lead proximal to the stimulation electrodes is generally positioned at the dorsal aspect of the sacral foramen through which the lead passes to anchor the lead in place. Figure 2C shows a detailed view of the nerves of the lumbosacral nerve trunk and sacral plexus, particularly the S1 - S5 nerves of the lower sacrum. The S3 sacral nerve is of particular interest for the treatment of bladder - related dysfunction, particularly OAB.

[0038] Figure 3 schematically illustrates an example of a fully implanted nerve stimulation system 100 adapted for sacral nerve stimulation. The nerve stimulation system 200 includes an IPG implanted within the lower back region and connected to a nerve stimulation lead extending through the S3 foramen for stimulation of the S3 sacral nerve. The lead is tethered by a tine anchor portion 30 that maintains the position of the set of nerve stimulation electrodes 40 along the target nerve, which in this example is the anterior sacral nerve root S3 that de - activates the bladder, to provide therapy for various bladder - related dysfunctions. Although this embodiment is adapted for sacral nerve stimulation, it is understood that similar systems can also be used in the treatment of patients suffering from, for example, chronic, severe, intractable neuropathic pain arising from peripheral nerves, or various voiding dysfunctions, or yet other indications. An implantable nerve stimulation system can be used to stimulate either a target peripheral nerve or the posterior epidural space of the spine.

[0039] The characteristics of the electrical pulses can be controlled via a controller of an implanted pulse generator. In some exemplary embodiments, these characteristics can include, for example, the frequency, amplitude, pattern, duration, or other aspects of the electrical pulses. These characteristics can include, for example, voltage, current, and the like. The control of the electrical pulses can include creating one or more electrical pulse programs, plans, or patterns, and in some exemplary embodiments, this can include selecting one or more existing electrical pulse programs, plans, or patterns. In the embodiment illustrated in FIG. 3, the implantable nerve stimulation system 220 includes a controller within the IPG that has one or more pulse programs, plans, or patterns that can be pre-programmed or created as described above. In some exemplary embodiments, these same characteristics associated with the IPG can be used in the EPG of a partially implanted test system that is used prior to implantation of the permanent nerve stimulation system 200.

[0040] FIG. 4 illustrates an exemplary nerve stimulation system 300 that is fully implantable and adapted for sacral nerve stimulation therapy. The implantable system 300 includes an IPG 10 coupled to a nerve stimulation lead 20 that includes a group of nerve stimulation electrodes 40 at a distal end of the lead. The lead includes a lead anchor portion 30 having a series of tines that extend radially outwardly to tether the lead and maintain the position of the nerve stimulation lead 20 after implantation. The lead 20 further includes one or more radiopaque markers 25 that can assist in locating and positioning the lead using visualization techniques such as fluoroscopy. In some exemplary embodiments, the IPG provides monopolar or bipolar electrical pulses that are delivered to the target nerve via one or more nerve stimulation electrodes. In sacral nerve stimulation, the lead is generally implanted through the S3 foramen as described herein.

[0041] As shown in the schematic diagram of the nerve stimulation system of FIG. 1, the system may further include a patient remote device 70 and a CP60, each configured to wirelessly communicate with an implanted IPG or, during testing, an EPG. The CP60 can be a tablet computer used by a clinician to program the IPG and EPG. The device also has the ability to record stimulus-evoked electromyogram (EMG) to facilitate lead placement, programming, and / or reprogramming. The patient remote device is a battery-operated portable device that utilizes radio frequency (RF) signals to communicate with the EPG and IPG, enabling the patient to adjust the stimulation level, check the status of the IPG battery level, and / or turn the stimulation on or off.

[0042] In one aspect, the IPG is rechargeable by using a charging device 50 (CD), which is a portable device that wirelessly charges the IPG via inductive coupling, is powered by a rechargeable battery, and enables patient mobility during charging. The CD is used for transcutaneous charging of the IPG via RF induction. The CD can be patch-fixed to the patient's skin using an adhesive or held in place using a belt 53 or an adhesive patch 52 as shown in the schematic diagram of FIG. 1. The CD can be charged by directly plugging the CD into an outlet or by placing the CD in a charging dock or charging station 51 that is connected to an AC wall outlet or other power source.

[0043] In one aspect, the CD includes one or more communication antennas that enable communication with the IPG. In this embodiment, this communication means is by shortwave radio waves, generally MedRadio. Generally, this communication means (e.g., MedRadio) has been used to communicate with the IPG during the charging session. However, since the CD also includes other communication means by which the CD can communicate with one or more additional external devices, this communication means can also be used to facilitate reprogramming by a remote support entity. In some exemplary embodiments, this additional communication can include communication with a patient device (e.g., by Bluetooth). This configuration enables the CD to communicate with both the IPG and the patient device, so the charger can be utilized to establish communication for programming between the remote support and the IPG, as will be described in more detail below.

[0044] Figures 5A - 5B show detailed views of the IPG and its internal components. In some embodiments, the pulse generator can generate one or more non - ablative electrical pulses that are delivered to a nerve to control pain or produce some other desired effect, such as inhibiting, preventing, or interfering with nerve activity for the treatment of OAB or bladder - related dysfunction. In some applications, the pulses can have a pulse amplitude in the range of 0 mA to 1,000 mA, 0 mA to 100 mA, 0 mA to 50 mA, 0 mA to 25 mA, 0 mA to 12.5 mA, and / or any other range or intermediate range of amplitudes can be used. The one or more pulse generators can include a processor and / or a memory that is adapted to provide instructions to other components of an implantable nerve stimulation system and receive information from such other components. The processor can include a microprocessor such as a commercially available microprocessor from Intel® or Advanced Micro Devices, Inc.®. The IPG can include an energy storage configuration such as one or more capacitors, one or more batteries, and generally includes a wireless charging unit.

[0045] One or more characteristics of the electrical pulse can be controlled via a controller of the IPG or EPG. In some exemplary embodiments, these characteristics can include, for example, frequency, amplitude, pattern, duration, or other aspects of the timing and magnitude of the electrical pulse. These characteristics can further include, for example, voltage, current, etc. The control of this electrical pulse can include creating one or more electrical pulse programs, plans, or patterns, and in some exemplary embodiments, this can include selecting one or more existing electrical pulse programs, plans, or patterns. In one aspect, the IPG 100 includes a controller having one or more pulse programs, plans, or patterns that can be created and / or pre-programmed. In some exemplary embodiments, the IPG can be programmed to vary stimulation parameters including pulse amplitude in the range of 0 mA to 10 mA, pulse width in the range of 50 μs to 500 μs, pulse frequency in the range of 5 Hz to 250 Hz, stimulation mode (e.g., continuous or cycle), and electrode configuration (e.g., anode, cathode, or off) to achieve an optimal treatment outcome individualized for the patient. In particular, this enables the optimal settings to be determined for each patient, even though each parameter can vary from individual to individual.

[0046] As shown in FIGS. 5A - 5B, the IPG may include a header portion 11 at one end and a ceramic portion 14 at the opposite end. The header portion 11 houses a feed - through assembly 12 and a connector stack 13, while the ceramic case portion 14 houses an antenna assembly 16 that facilitates wireless communication with a clinical medical programming device, a patient remote device, and / or a charging coil and facilitates wireless charging by CD. The remaining portion of the IPG is a titanium case portion 17, which is covered by a titanium case portion 17 that houses a printed circuit board, memory, and controller components that facilitate the electrical pulse program described above. The header portion of the IPG is a connector stack 13 that includes a 4 - pin feed - through assembly 12 that couples to the connector stack 13 with the proximal ends of the leads coupled inside the connector stack 13. The four pins correspond to the four electrodes of the nerve stimulation lead. In some exemplary embodiments, a Balseal® connector block is electrically connected to four platinum - iridium alloy feed - through pins that are brazed to an alumina ceramic insulator plate with a titanium alloy flange. This feed - through assembly is laser seam welded to a titanium - ceramic brazed case, forming a completely sealed housing for the electronics.

[0047] In some embodiments, such as the embodiment shown in FIG. 5A, a ceramic case and a titanium brazed case are utilized at one end of the IPG where a ferrite coil and a PCB antenna assembly are disposed. A reliable hermetic seal is provided by a ceramic-metal brazing technique. The zirconia ceramic can be composed of 3Y-TZP (3 mol% yttria-stabilized tetragonal zirconia polycrystal) ceramic, which has high flexural strength and impact resistance and is commercially utilized in a plurality of implantable medical technologies. In one aspect, since the communication antenna is stored inside the hermetic ceramic case, the use of the ceramic material provides an efficient radio frequency transmission window for wireless communication with an external patient remote device and a clinician programming device. This ceramic window further promotes miniaturization of the implant while maintaining an efficient radio frequency transmission window for long-term and reliable wireless communication between the IPG and external controllers such as patient remote devices and CPs. In other aspects, the ferrite core is part of a charging coil assembly 15 disposed inside the ceramic case 14 shown in FIG. 5B. The ferrite core concentrates the magnetic flux through the ceramic case rather than through the metal case portion 17. This configuration maximizes the coupling efficiency, which reduces the required magnetic field and thus reduces device heating during charging.

[0048] In one aspect, the IPG can be programmed according to various stimulation modes that are determined by the CP during initial programming or during remote programming, or can be selected by a physician using the CP. In some exemplary embodiments, the IPG / EPG can be configured to have two stimulation modes, namely, a continuous mode and a cycle mode. The cycle mode saves energy compared to the continuous mode, thereby extending the battery recharge interval and the device lifespan. The cycle mode can also help reduce the risk of neural adaptation for some patients. Neural adaptation is the change over time in the responsiveness of the nervous system to a constant stimulation. Thus, the cycle mode can also relax neural adaptation and provide longer-term therapeutic benefits. FIG. 6A shows an example of stimulation in the cycle mode, where in this example, the duty cycle is the ratio of the stimulation on time to the stimulation on time + stimulation off time. In some exemplary embodiments, the IPG / EPG can be configured to have a ramping configuration as shown in the example of FIG. 6B. In these embodiments, the stimulation signal is ramped up and / or ramped down between a stimulation on level and a stimulation off level. This configuration helps reduce the sudden "spasmodic" or "jolting" sensations that some patients may experience when the stimulation is first turned on or during the cycle on phase during the cycle mode. This configuration is particularly beneficial for patients who require relatively high stimulation settings and / or who are sensitive to electrical stimulation.

[0049] To activate the axons of nerve fibers, it is necessary to apply an electric field outside the axons to create a voltage gradient across the membrane. This can be achieved by pumping charge between the electrodes of the stimulating device. When the outside of the nerve is depolarized up to a certain threshold, which is determined by the amount of current delivered, an action potential that transmits information through the nervous system is generated. To generate continuous action potentials within the axon, this extracellular gradient threshold needs to be reached with each delivery of a stimulus pulse. To activate the axons of nerve fibers, it is necessary to apply an electric field outside the axons to create a voltage gradient across the membrane. This can be achieved by pumping charge between the electrodes of the stimulating device. When the outside of the nerve is depolarized up to a certain threshold, which is determined by the amount of current delivered, an action potential that transmits information through the nervous system is generated. To generate continuous action potentials within the axon, this extracellular gradient threshold needs to be reached with each delivery of a stimulus pulse.

[0050] In conventional systems, a constant-voltage power supply can maintain the output voltage of the electrodes such that sufficient current is delivered to activate the axons during initial implantation. However, during the first few weeks after implantation, tissue encapsulation occurs around the electrodes, which results in an increase in impedance (tissue resistance). According to Ohm's law (I = V / R, where I is current, V is voltage, and R is the tissue impedance of the electrode pair), the current delivered by a constant-voltage stimulating device will thus decrease, creating a smaller gradient around the nerve. When the impedance reaches a certain value, extracellular depolarization falls below the threshold, and no further action potentials can be generated within the axon. Patients generally need to adjust the voltage of their systems to readjust the current and restore the effectiveness of the therapy.

[0051] In contrast, certain exemplary embodiments utilize a constant current power supply. In one aspect, the system uses feedback to adjust the voltage so that the current is maintained regardless of what happens to the impedance (until the compliance limit of the device is reached), and thus the gradient field around the nerve is maintained for a defined period of time. Using a constant current stimulator continues to deliver the same initially selected current for maintaining the effectiveness of the treatment, regardless of impedance changes.

[0052] FIG. 7 schematically illustrates a block diagram of the configuration of CP60, the associated interface, and the internal components. As described above, CP60 is generally a tablet computer having software that operates on a standard operating system. CP60 includes a communication module, a stimulation module, and an EMG sensing module. The communication module communicates with the IPG and / or EPG within the medical implant communication service frequency band to program the IPG and / or EPG. While this configuration reflects a portable user interface display device such as a tablet computer, it is understood that the CP can be incorporated inside various other types of computing devices such as laptops, desktop computers, or stand-alone terminals for use in medical facilities.

[0053] D. Workflow for Programming and Reprogramming by CP FIGS. 8-9 illustrate schematic diagrams of the workflows used in lead placement and programming of a nerve stimulation system with EMG assist using a CP. FIG. 8 schematically illustrates a detailed overview of the use of a CP having a graphical user interface for lead placement and subsequent programming, which may include initial programming and reprogramming. FIG. 9 illustrates a schematic diagram of a CP graphical user interface screen representation of the workflow including various setups and connections associated with each step.

[0054] III. Nerve Stimulation Programming After lead implantation and nerve localization, the nerve stimulation system is programmed. Generally, programming is the evaluation of stimulation thresholds and / or electrode characteristics, which can be performed specifically for programming or during lead implantation and then utilized during programming. Predetermined stimulation thresholds or electrode characteristic evaluations can be stored in any of the devices of the illustrated system or in the system's first-party developer's data center and accessed during programming or reprogramming by remote support or the patient device. Although some programming examples herein describe the use of EMG measurements to provide information for electrode characteristic evaluation, as is known in the art, these EMG measurements can be stored and then utilized in reprogramming procedures, and it is understood that various other approaches that do not use EMG can be used.

[0055] In some exemplary embodiments, the system stores the last four programs used on-board in the IPG / EPG memory. This is particularly advantageous for reprogramming as it allows a physician to access, with a completely different CP that would otherwise not have access to the programming information, the most recent program used in nerve stimulation. In other aspects, the programming data can be accessed online or on a cloud server such that different CPs can easily access and download the programming information as needed for reprogramming and can be associated with a unique identifier of a given IPG / EPG.

[0056] A. Electrode Characteristic Evaluation In one aspect, during lead implantation, CP60 can utilize pre-recorded thresholds when characterizing each electrode with respect to its suitability for use in nerve stimulation. In some exemplary embodiments, CP60 can be configured to program the IPG / EPG based on any one of EMG recordings from only one muscle, the anal sphincter response, or the big toe response of the foot. Such programming can also utilize visual observation of the response in addition to the recorded maximum response amplitude. In one aspect, CP60 performs programming without requiring observation of the anal sphincter response or EMG waveform measurement of the anal sphincter response. In some exemplary embodiments, CP60 uses an EMG recording from only the big toe response of the foot as shown in FIG. 15C, and in this EMG recording, the graphical user interface of the CP displays patient information 63 that can include information regarding the patient's subjective response to the stimulation or treatment, and performs programming using this EMG recording. In an alternative embodiment, CP60 can be used to program the EPG / IPG using an EMG from only the anal sphincter response.

[0057] In one aspect, the EMG recording can be obtained during lead implantation or, more generally, during programming such that the patient can provide subjective sensory response data in parallel with performing a big toe response with a given electrode during testing. The programming can further include visual observation of the big toe response and / or the maximum response amplitude obtained during programming. Enabling programming of the IPG / EPG without requiring the anal sphincter response is advantageous because the patient is not under general anesthesia while the programming is being performed and the anal sphincter response can be uncomfortable and painful for the patient. This also enables the CP to receive subjective sensory data from the patient regarding any discomfort, paresthesia, or pain associated with stimulation of a particular electrode configuration during programming.

[0058] In one aspect, EMG recordings can be obtained during lead placement or, more generally, during programming such that the patient can provide subjective sensory response data in parallel with performing a big toe response with a given electrode during the test. Programming can further include visual observation of the big toe response and / or the maximum response amplitude obtained during programming. Enabling IPG / EPG programming without requiring an anal sphincter response is advantageous because the patient is not under general anesthesia while the programming is being performed and the anal sphincter response can be uncomfortable and painful for the patient. This also enables the CP to receive subjective sensory data from the patient regarding any discomfort, paresthesia, or pain associated with stimulation of a particular electrode configuration during programming.

[0059] B. Electrode Configuration Recommendations In one aspect, the system configuration determines a plurality of electrode configuration recommendations based on an electrode characteristic evaluation and / or the use of threshold data that is partially based on patient responses to electrode stimulation that was previously obtained (e.g., by EMG observation or visual observation), and provides the recommendations to the clinician. FIG. 10 illustrates an exemplary method for determining and providing electrode configuration recommendations implemented by the CP. In such a method, the system first checks the impedance of each electrode using pre-set stimulation parameters and can exclude any electrode having an unacceptable impedance (<50 or >3,000 ohms) from being assigned as an anode or cathode. Subsequently, the system identifies threshold data associated with each electrode from pre-recorded data during lead placement or by generating new threshold data. The system hierarchically orders the electrodes based on the threshold (e.g., "good", "OK", "bad") and ranks the electrodes within each hierarchy. Any electrode that produces an uncomfortable sensation is excluded from being used as a cathode. Subsequently, the system determines a plurality of electrode configuration recommendations, preferably at least four different configurations, according to a predetermined rule, which is subsequently presented to the clinician using the CP.

[0060] In one aspect, the electrode configuration is determined according to the following rules based on the threshold data: (1) Prioritizing from the farthest pair to the closest pair, a single cathode configuration is assigned to each contact within the "Good" tier. (2) Prioritizing from the lowest threshold to the highest threshold, a single cathode configuration is assigned to each contact within the "Good" tier. (3) A dual cathode configuration is assigned to each pair of adjacent electrodes within the "Good" tier, prioritized by the lowest total threshold. (4) Prioritizing from the lowest threshold to the highest threshold, a single cathode configuration is assigned to each contact within the "OK" tier. (5) Prioritizing by the lowest total threshold, a dual cathode configuration is assigned to each pair of adjacent electrodes from the "Good" and "OK" tiers. The anode for the cathode configuration is assigned as follows: For a monopolar configuration, the IPG housing or the "can" is assigned as the anode. For a bipolar configuration, the electrode farthest from the cathode having an acceptable impedance is assigned as the anode.

[0061] After identifying the electrode configuration recommendation, the system presents the electrode configuration recommendation to the physician, generally on a CP user interface as shown in FIG. 11, on which the physician can select any of the electrode configurations for testing, or modify the recommended electrode configuration as desired, or create a new electrode configuration. In one aspect, the system presents the electrode configuration recommendation within a selectable menu that may include one or more default values or attributes for a given electrode recommendation.

[0062] In one aspect, in an idealized setting where each of the electrodes has a "good" impedance, the system simply recommends each of the contacts as a single cathode. While it is desirable to have four "good" electrodes, for initial programming, it is acceptable to have at least three "good" electrodes. The algorithms described above recommend the best electrode selection for a given case. Although each physician may have their own method of selecting electrodes for programming, providing a set of electrode configuration recommendations that are easily browsed and selected by the physician standardizes the process, shortens the procedure duration, and is particularly useful for inexperienced implanters or staff with minimal training in providing improved patient outcomes.

[0063] In one aspect, the algorithms described above assume a single input parameter for the electrode threshold. In some exemplary embodiments, the system enables the physician to select the parameter(s) (sensory response, or motor response, or combination) to be used to determine the threshold for each electrode via the CP. The physician may also choose whether to rely on pre-acquired EMG feedback for threshold determination. In other aspects, qualitative sensory feedback is considered in electrode selection; for example, if the patient reports discomfort with any particular electrode, this electrode will be excluded from being used as a cathode. In other aspects, the algorithm prefers a single cathode over a dual cathode for all contacts within the "good" tier. In some exemplary embodiments, the electrodes are stratified according to the following tiers: "good" = "1 - 3 mA"; "OK" = "0.5 - 1 mA" and "3 - 4 mA"; "bad" = "<0.5 mA" and ">4 mA".

[0064] Figures 12A - 12B illustrate a case study depicting the selection of four electrode recommendations for bipolar and monopolar treatments according to the above-described algorithm for Case 1 in Figure 12A and Case 2 in Figure 12B, respectively.

[0065] C. Program Selection, Modification, and Testing In programming a nerve stimulation system, an EMG signal can be used to evaluate programming quality by enabling the user to confirm whether a motor response has been induced by a stimulus. In some exemplary embodiments, the user may manually observe the EMG response, enter the observation results into the CP, and attempt to set the stimulation amplitude to a level that induces the desired motor response.

[0066] Figures 13A - 13K illustrate the graphical user interface of the CP during initial programming and testing, although it is understood that various aspects are also applicable to reprogramming. Figure 13A illustrates the reconnection of the CP60 to the patient device and the verification of device information. The physician may review this before proceeding with programming by viewing the device information display 66 shown in Figure 13B. Figure 13B is an IPG data display showing threshold summaries and contact status. Threshold data from "lead placement" is recorded and can be viewed in the summary form on this page. The symbol to the right of each contact represents the impedance associated with that contact: green ("good"): 50 - 3,000 ohms, red ("bad"): <50 or >3,000 ohms. In some exemplary embodiments, yellow may indicate "insufficient", while in other embodiments, there may be no yellow option. The colored circle around each contact represents the qualitative assessment of that contact from lead placement. This is a summary of the information within the "Threshold Details" tab. As shown in Figure 13B, electrode #0 and electrode #1 are shown in green, electrode #2 is shown in orange, and electrode #3 is shown in red. In one aspect, the CP60 may program the IPG / EPG by using the EMG waveform, and / or visual response data and patient sensation data obtained by the CP60 during lead placement. Programming may also utilize additional patient information obtained from the patient during programming (e.g., subjective input regarding sensory perception).

[0067] Figure 13C illustrates a test of the first electrode configuration recommendation shown on display 67, which is the programming of the IPG and display 67, showing four electrode configuration recommendations determined according to the algorithm described above. The electrode configuration recommendations are based on inputs from the threshold details determined during lead placement property evaluation. It is understood that the electrode thresholds can also be determined during programming. The colored circles around each contact represent the qualitative assessment of that contact from lead placement. This is a summary of the information in the "Threshold Details" tab. The presence of motor responses and the quality of sensory responses are manually recorded for retrospective data analysis purposes. Amplitude adjustment can be done in automatic adjustment increments or fixed increments as described above.

[0068] In the first electrode configuration recommendation in Figure 13C, the lead operates in bipolar mode between electrode 0 and electrode 3, with electrode #0 acting as the cathode and electrode #3 acting as the anode. The same procedure is repeated for each of the four electrode recommendations shown in Figure 13D, in which a dual cathode configuration is being tested.

[0069] In one aspect, the graphical user interface enables the user to adjust various parameters associated with each of the recommended electrode configurations being tested. For example, as shown in FIG. 13E, the graphical user interface of the CP60 includes an additional parameter display 68, in which the physician can select and adjust various parameters (e.g., frequency, pulse width, cycle, and mode) associated with each electrode configuration according to a specific treatment and / or the patient's needs. After adjustment, the patient information and program information can be updated and recorded in the CP60. In other aspects, as shown in FIG. 13G, the physician can use the CP to reassign the electrode polarities associated with a given electrode configuration recommendation, and in this case, the cursor can be used to change the electrode polarities on the electrode status display 64. In yet other aspects, the user can switch between bipolar and unipolar modes by selecting a mode button within the additional parameter display 68. When the unipolar mode is selected, the CP60 will display a plurality of unipolar electrode configuration recommendations as shown in FIG. 13H. When the physician is satisfied with the electrode configuration settings, the physician can proceed to save the settings to the CP60 by selecting the patient device menu as shown in FIG. 13J and viewing the current therapy display 69 shown in FIG. 13K and saving the therapy to the patient device. After this step, the IPG / EPG is fully programmed and the CP60 can be removed.

[0070] In one aspect, after programming of the IPG / EPG according to the method described above, the patient evaluates the selected program over a predetermined period. Generally, the patient can make limited adjustments to the program, such as increasing or decreasing the amplitude or turning the treatment off. After the evaluation period, if the patient does not experience relief from the treated symptoms or other problems occur, the patient returns to the physician and the IPG / EPG is reprogrammed such that the CP selects an alternative electrode configuration from the recommended configurations or develops a new treatment program to provide an effective treatment in a process similar to the programming method described above.

[0071] V. Remote Programming In one aspect, the methods and devices described throughout facilitate remote programming of the IPG. As described herein, "reprogramming" simply refers to the programming operations that occur after initial programming and can include determining an entirely new program or troubleshooting the current therapy program by remotely modifying one or more therapy parameters. Reprogramming can utilize some information obtained beforehand during lead placement or initial programming, or can repeat the programming procedure, or can utilize alternative programming procedures. In some exemplary embodiments, the programming procedure can utilize an algorithm or rules to determine an appropriate therapy program from known parameters. In other embodiments, the programming procedure can include a clinician applying or adjusting parameters according to their preference. It is understood that any aspect of the programming procedures described herein is also applicable to remote reprogramming.

[0072] A. Patient Interface / Session Initiation In one scenario, after a patient has had a nerve stimulation lead and an implantable pulse generator implanted, the patient may experience an unsatisfactory therapy due to lack of efficacy or discomfort from the stimulation and may desire reprogramming. Various aspects of the process by which reprogramming may be performed or information may be obtained are detailed below.

[0073] In some exemplary embodiments, the patient enters a bladder diary or bowel diary included in a "patient app" installed on a patient device (e.g., a smartphone) in order to "authorize" or enable a remote programming function. An integrated symptom diary (bladder diary and / or bowel diary) enables the patient to keep a diary of their symptoms over a period of time that is prior to and in anticipation of an initial assessment of device suitability and immediately following a reprogramming session. In some exemplary embodiments, a programming technician may remotely access this information to evaluate the need for programming. Alternatively, the diary function may be implemented on various other devices such as a tablet, laptop, desktop computer, etc.

[0074] In some exemplary embodiments, the patient places a charger on top of the IPG and the charger communicates with the patient app on the patient device. In some exemplary embodiments, the communication from the charger to the IPG is MedRadio, while the communication from the charger to the patient app is Bluetooth. In other embodiments, the system utilizes a patient remote device that communicates with the IPG via MedRadio and connects to the patient app on the patient device via Bluetooth.

[0075] In some exemplary embodiments, a patient app on a patient device (e.g., a smartphone) communicates with a remote programming service via Wi-Fi. Generally, the patient app can be configured to utilize Bluetooth functionality (e.g., to a charger) and Wi-Fi functionality. In some exemplary embodiments, VoIP (Voice over Internet Protocol) technology can be incorporated into the patient app, for example, by using Skype integration, to avoid the need for a standard voice call. In other embodiments, the system can utilize a specialized dedicated relay communication device that communicates with the IPG via MedRadio and connects to the patient device via Bluetooth. In still other embodiments, the system can utilize a dedicated patient device that communicates with the IPG via MedRadio and connects to the remote programming service via Wi-Fi.

[0076] B. Remote Programming Functionality In other aspects, the patient app of the patient device can be configured to communicate with a remote programming “backend” via Wi-Fi. In some exemplary embodiments, the communication includes a voice or video chat connection between the patient and the programming technician, in addition to the data connection. The backend components can be introduced in a plurality of ways, including either a cloud-based, local server, or hosted server. The communication can include any of the following aspects: program information (e.g., current therapy, electrode characteristic evaluation, stimulation threshold), and patient information (e.g., account, profile information, symptom information diary from the patient).

[0077] In other aspects, the reprogramming procedure can utilize a doctor app or a remote programming app (these terms are used interchangeably throughout), which can be a mobile / web app provided to the browser. This approach provides maximum flexibility and scalability. This approach further provides versatility among several options for the structure of the support team, such as a virtual call center by technicians of a device provider, a team of technicians in a call center, and a virtual call center team of contract clinicians (e.g., super users, nurse practitioners, or doctors). In some exemplary embodiments, the application can be configured to provide a direct connection from the patient to a doctor / clinician of their choice, which may be preferred for clinicians who wish to maintain control over the entire process. In some exemplary embodiments, the patient app cannot be accessed via a browser and needs to be installed on the patient's portable device (e.g., smartphone, tablet).

[0078] In other aspects, the remote programming app synchronizes with additional databases as needed. These additional databases can include a Patient Care Manager (PCM) that enables support technicians to view the therapy history of the relevant patients. In some exemplary embodiments, the patient's recent therapy history can be obtained from the IPG by a charger or a patient remote device and shared via the patient app connection to the remote programming app. Thus, the patient app and the remote programming app create an application framework through which the patient and remote support can communicate and through which information access via any of the target devices is communicated. In one aspect, this framework enables remote support to perform authentication and authorization for an implanted pulse generator beyond that of the patient, for the purpose of controlling and / or adjusting the implanted pulse generator for programming purposes.

[0079] C. Remote Programming Process (Patient / Technician Communication) The system application is configured for a technician to receive communication (e.g., a "call") from a patient who desires that their device settings be remotely adjusted, typically initiated via a patient app. In some exemplary embodiments, subsequently, remote support may access the patient's history stored in a patient database (e.g., a patient care management device) and, via a voice call or video call conducted through an application framework, communicate live with the patient about the patient's needs. In some exemplary embodiments, the technician transmits new settings to the patient's IPG via the patient's own mobile device during a call session. In some exemplary embodiments, any setting except amplitude may be remotely adjusted. In some exemplary embodiments, the patient needs to increase the amplitude on the patient remote device, thereby minimizing the risk of unintended stimulation / discomfort.

[0080] In other aspects, the patient gives explicit permission for the setting change to be transferred to the stimulation device via the user interface of the patient app, or gives permission to the remote support to make changes to the IPG in real time. In some exemplary embodiments, the patient uses the patient remote device to increase the amplitude and explains to the technician any resulting change in sensation or discomfort, and the technician adjusts the settings accordingly. In some exemplary embodiments, the patient remote device can access the full amplitude range (similar to when programming by a CP), and when using a charger as a communication bridge from the IPG to the smartphone, communicates with the IPG while the charger is also connected. In some exemplary embodiments, at the completion of the programming activity, either the technician or the patient can disconnect the programming connection via the patient app or a remote programming app.

[0081] D. Clinical Medical Interface In other aspects, the system utilizes remote devices that can be CPs, in addition to standard computing devices (e.g., smartphones, tablets, laptops, desktops). Standard computing devices can be configured to facilitate remote programming using a remote programming app. In some exemplary embodiments, the remote programming app can be a web app accessed using a standard browser. In some exemplary embodiments, physicians can access reports of remote programming activities and view records / reports regarding remote programming sessions for their patients. In some exemplary embodiments, the patient app can be installed only on the patient's personal computer device and cannot be accessed via a browser.

[0082] E. Examples of Remote Programming Systems The above-described aspects of the remote reprogramming process can be further understood by referring to FIGS. 14-20.

[0083] FIG. 14 schematically illustrates a remote programming system 400 according to some exemplary embodiments. The remote programming system includes an IPG 401 that communicates with a remote support 430 via local relay devices 410, 420, which may include any of a patient remote device 411, a charger 412, a laptop 422, a smartphone 421, or a specialized dedicated reprogramming device 423. Generally, the communication path involves the IPG communicating with a first relay device 410, which communicates with a patient device 420, which communicates with the remote support 430. In this embodiment, the first relay device may be a charger 411 or a patient remote device 412, and the patient device 420 may be a smartphone 421, a laptop 422, or a specialized dedicated programming device 423. Preferably, the communication system includes the IPG 401, the charger 411, the smartphone 421, and the remote support 430, which is advantageous because the charger is easily rechargeable, and using a smartphone improves versatility and mobility and does not require additional dedicated equipment. It is understood that the remote programming procedure may utilize any combination of the illustrated devices and communication paths.

[0084] In one aspect, local communication between local devices may utilize shortwave wireless communication, such as MedRadio or Bluetooth. In this embodiment, communication between the IPG401 and the remote support 430 may be performed via a plurality of alternative communication paths (indicated by dashed and solid lines) and different types of communication. The IPG401 generally communicates via MedRadio so that each of the patient remote device 412 and the charger 411 already has the function to communicate with the IPG via MedRadio, making them well-suited for use as relay devices. Each of the patient remote device and the charger may also be configured to communicate via Bluetooth so that either can be used to facilitate communication with the patient via the patient device 420. In this approach, the patient's personal computing device may be configured for remote programming using a patient app, which is a dedicated executable application program stored on the memory of the patient device. The patient app is a framework that establishes a framework by which the patient can input subjective information regarding their treatment, communicate with the remote support entity to facilitate reprogramming, and securely transmit program information for the purpose of remote programming. In some exemplary embodiments, the system may utilize a specialized dedicated device 422 developed specifically for reprogramming. Such a device may be configured to communicate with a first relay device via Bluetooth as described above, or via MedRadio. In some exemplary embodiments, the dedicated device may be configured to communicate directly with the IPG via MedRadio such that only a single relay local device is required. The remote support 430 communicates with the patient device via a network (e.g., via Wi-Fi, cellular, wired connection, or any combination thereof). The remote support 430 may be cloud-based, or may utilize a first-party server or a hosted server.

[0085] In some exemplary embodiments, the first relay device is an existing charger or patient remote device, in which the software is updated and the function as the first relay device is enabled. For example, the software enables the charger or patient remote device to function as an interpreter between an implanted medical device and another external device (e.g., the second relay device) that uses a different communication method. Specifically, the first relay device passes any command or request received from the second relay device in a certain communication method (e.g., Bluetooth), converts this command or request to another communication method (e.g., MedRadio), and transmits the converted command or request to the implanted device. In this way, the second relay device requests information from the implanted medical device, and this request is passed by the first relay device to the implanted medical device in an appropriate communication method. In response to receiving this request, subsequently, the implanted medical device outputs the communication of the requested information, and this communication is received by the first relay device and transmitted to the second relay device according to an appropriate communication method. In this way, the first relay device simply relays any commands and requests received between the implanted medical device and the second relay device. In some exemplary embodiments, the first relay device has not substantially changed the content of the request or command, has not responded to the content of the request or command, and has not even responded to the device that is the source of the command or request.

[0086] In some exemplary embodiments, the implanted medical device stores any information regarding therapy (e.g., current programming parameters, alternative programs, electrode information, patient information, etc.). During the programming procedure, to the extent this information is requested by a remote entity, this information is retrieved from the memory of the implanted medical device. In some exemplary embodiments, while some of this information may be retrieved from a second relay device (e.g., a smartphone, laptop), or a remote server communicating with a remote support entity, generally, this information is stored on the implanted medical device and is requested from the implanted medical device during reprogramming. In some exemplary embodiments, the request for information is received by a first relay device. In response to this request, the first relay device passes this request to the implanted medical device in an appropriate communication manner. In response to receiving this request, the implanted medical device accesses the requested stored information and subsequently outputs this information to the second relay device via the first relay device as described above. Thus, in the described embodiments, the software configuration of the first relay device is limited to the role of the first relay device in passing a request from one device to another in accordance with an appropriate communication manner. In some exemplary embodiments, any command, request, or information passed between devices may be temporarily stored on the first relay device only to the extent necessary to relay the command, request, or information between the devices. In some exemplary embodiments of the remote programming procedure, the implanted medical device is the single source of information regarding the current therapy program and parameters, which is advantageous as it avoids any potentially conflicting information regarding the current therapy being applied.

[0087] Figures 15A-15B schematically illustrate a communication setup for remote programming between a patient device and an implanted medical device using a dedicated device as a first relay device, according to some exemplary embodiments. In FIG. 15A, the first relay device is a plug-in accessory 1510 that is plugged into the patient device 1520 such that the plug-in accessory 1510 communicates directly with the patient device 1520 and is powered by the patient device 1520. The plug-in accessory 1510 includes communication means for wirelessly communicating with the implanted medical device 1501, typically via MedRadio. This approach enables a smartphone without MedRadio communication means to be used as the patient device 1520 and communicate with the implanted medical device without the need for a charger or a patient remote device. In some exemplary embodiments, the plug-in accessory 1510 may further include a memory storing software, which may include any additional configuration such as software for the IPG, and / or an authentication function to ensure secure communication with remote support, or a patient app, and / or software related to reprogramming procedures. In FIG. 15B, the first relay device may be configured as a separate, specialized dedicated communication device 1511 that communicates wirelessly and locally with both the IPG and the patient device 1520. In this embodiment, the communication device communicates with the IPG via MedRadio and with the patient device 1520 via either Bluetooth or NFC. Similar to the plug-in accessory 1510 described above, the communication device 1511 may further include a memory having software for reprogramming procedures, which may include an authentication function or a patient app. In this embodiment, the relay device 1511 has its own power source. The approaches described above may be advantageous in that the devices 1510, 1511 may be configured to have additional features and capabilities that may exceed those of the current charger or patient remote device described above.

[0088] Figure 16 schematically illustrates a communication system setup 1600 between a patient device and a remote support entity according to some exemplary embodiments. In this embodiment, the patient device 1620 communicates remotely via Wi-Fi with a remote device / remote entity 1640 through a remote server 1630. In some exemplary embodiments, this communication may be performed via a cellular connection or a wired connection, or any combination of Wi-Fi, cellular connection, and wired connection. In this embodiment, the remote server 1630 can be any of a first-party server 1632 of the developer of the nerve stimulation system, a cloud server 1631, or a hosted server 1633. The remote device / remote support entity 1640 can be a remote support team 1641 of the first-party developer, a call center 1642, or a consulting clinician 1643 including contract clinicians or treating physicians. The remote entity utilizes a remote device, receives input from a physician regarding reprogramming, and communicates with the patient. The remote device can be any computing device including a smartphone, a tablet, a laptop, a clinical programming device, or a desktop computer. In this embodiment, the remote device can include a physician app or a remote programming app framework that facilitates communication via the patient app of the local patient device 1620. In some exemplary embodiments, the physician app can be provided to an internet browser and configured to be accessed by the remote device. This can improve the versatility in the setup of the remote entity so that the remote device can be any of a smartphone, a tablet, a laptop, and a desktop computing device. Although the device application of the remote support entity may sometimes be referred to as a "physician app", it is understood that the remote support does not have to be a physician, and can include clinicians, medical experts, in addition to technical experts or consultants having expertise in programming or programming troubleshooting.It is understood that the remote programming procedure may utilize a remote entity, and / or a server, or any combination of the illustrated communication paths.

[0089] FIG. 17 schematically illustrates a workflow 1700 that depicts various communication paths and options for a remote programming setup according to some exemplary embodiments. The setup shows additional details regarding the functionality and steps of communication between the devices and entities of the remote programming setup described herein. This schematic shows which devices and functions may be associated with the first developer of the nerve stimulation system for third-party developers (e.g., smartphone / computer manufacturers, consultants, physicians). This schematic represents a particular embodiment, and it is understood that various alternatives or modifications are within the scope of the inventive concepts described herein. Further, any of the individual aspects and communications illustrated in FIG. 17 may be utilized in various other embodiments, including any of the alternative setups described herein.

[0090] FIGS. 18-20 illustrate exemplary methods of remotely programming an implanted medical device using a communication setup according to some exemplary embodiments.

[0091] FIG. 18 illustrates a method for facilitating remote programming of an implanted nerve stimulation system using one or more relay devices, according to some exemplary embodiments. Such a method may include receiving, by a remote device, a request for remote reprogramming and / or a patient request for reprogramming of an implantable pulse generator of a nerve stimulation system implanted in a patient. After receiving the request, the system establishes a communication session between the implantable pulse generator of the nerve stimulation system and the remote device associated with the remote support entity via one or more relay local devices for programming and / or reprogramming of the implantable pulse generator by the remote entity. Program information is received by the remote device via one or more local relay devices. The program information may include the current therapy program on the implanted nerve stimulation system. Further, the remote device receives patient information regarding the current therapy program via one or more local relay devices regarding the patient. Subsequently, the remote device receives a program update input from remote support for updating one or more parameters of the current program or a new program for the nerve stimulation system based on a current based on the therapy program information and the patient information. Subsequently, the system programs the implantable pulse generator using the program update of one or more parameters of the current program or the new program from the remote device via one or more relay devices.

[0092] FIG. 19 illustrates a method of remote programming using a patient device according to some exemplary embodiments. Such a method includes establishing, by the patient device, via the patient device, a communication session between an implantable pulse generator of a neuromodulation system implanted in a patient and a remote device associated with a remote support entity for programming and / or reprogramming of the implantable pulse generator by the remote entity; transmitting, by the patient device, patient information to the remote device, the patient information being associated with program information regarding a current therapy program applied by the implantable pulse generator of the implanted neuromodulation system; and subsequently, the patient device receiving a program update from the remote support device regarding an update of one or more parameters of the current program or a new program, and outputting the program update to the implanted neuromodulation system, thereby programming the implantable pulse generator using the program update of one or more parameters of the current program or the new program from the remote device via the patient device. In some exemplary embodiments, the patient device communicates via one or more relay devices including either the implantable pulse generator and any one of a patient remote device, a charger, a plug-in accessory, or a dedicated communication device.

[0093] FIG. 20 illustrates a method of remote programming using a remote device according to some exemplary embodiments. Such a method includes establishing a communication session between an implantable pulse generator of a neuromodulation system implanted in a patient and a remote device associated with a remote support entity for programming and / or reprogramming of the implantable pulse generator by the remote entity via one or more relay local devices; receiving, by the remote device via one or more relay local devices from a relay local device, program information including a current therapy program on the implanted neuromodulation system; receiving, by the remote device via one or more local relay devices from a relay local device associated with the current therapy program on the implanted neuromodulation system, patient information regarding the current therapy program; subsequently, determining or receiving, by the remote device via an update input, an update of one or more parameters of a current program or a new program for the implanted neuromodulation system based on a current based on the therapy program information and the patient information; and subsequently, programming, by the remote device via one or more relay devices including a patient device, the implantable pulse generator with a program update of one or more parameters of the current program or the new program.

[0094] Figure 21 shows an exemplary setup for facilitating remote programming according to some exemplary embodiments. Setup 500 includes a conventional IPG 501 that communicates with a first relay device (patient remote control 510), which in turn communicates with a second relay device (patient device 520, such as a laptop or smartphone), and the second relay device communicates remotely with a remote programming device 530 (e.g., a computing device of a manufacturer / company's sales diplomat or clinician). In this embodiment, the patient remote control 510 is dedicatedly configured with communication means (e.g., Bluetooth) suitable for wireless communication with the patient device 520. This patient remote control is in contrast to conventional patient remote controls that can communicate only with the IPG, e.g., via MedRadio. In some exemplary embodiments, the remote communication between the patient device 520 and the programming device 530 is performed via a cellular network. In some exemplary embodiments, the patient device 520 includes a dedicated software application (e.g., IPG communication software) for facilitating local communication with the IPG and remote communication with the programming device 530. The programming device 530 communicates with the IPG via the first and second relay devices and may include a corresponding application (e.g., IPG communication software) for a company's sales diplomat or clinician to facilitate remote programming by the sales diplomat or clinician via the user interface of the remote device. In some exemplary embodiments, the application software on the programming device 530 may be configured to enable adjustment of existing programs stored on the IPG, replacement of existing programs with alternative or newly determined programs, and download of IPG information (e.g., current or past programs, activities, etc.). In other embodiments, the remote programming is performed via a web-based portal accessible by each of the patient device 520 and the remote device 530.

[0095] Figures 22 - 26 illustrate various alternative setup options for facilitating remote programming according to several exemplary embodiments. These setups may utilize the existing communication capabilities of various devices or may include dedicated devices or software applications. In one aspect, these setups may utilize a patient database portal, which is designed to facilitate remote programming by leveraging communication to a secure server, particularly a web - based patient database portal (e.g., via Wi - Fi and / or cellular). The database portal can hold various types of data regarding a patient's treatment, such as 1) patient program history, 2) device event logs, and 3) patient bladder diaries. In some exemplary embodiments, the setup may be configured to enable a patient to self - program by utilizing information exchanged via the patient database portal, for example, by receiving from the portal a program updated or modified based on information previously obtained from the patient.

[0096] FIG. 22 shows a system setup 600 that utilizes a dedicated patient remote 610 to enable remote programming via the patient remote, thereby allowing the use of different types of IPGs. For example, the above-described embodiment that relies on a charging device for communication with the IPG is not suitable for use with an IPG having a non-rechargeable battery because the charging device is not used. This setup can leverage the functionality of existing patient programming devices with respect to communication with the IPG to be backward compatible. Since the patient remote communicates with the patient device 620 via Bluetooth, the setup further leverages the functionality of existing smartphones / tablets having Bluetooth communication and Wi-Fi communication. The setup can further utilize a hosted patient bladder / voiding diary application maintained by the patient using the patient device 620. Optionally, this setup can be provided only to patients who need to be reprogrammed. Advantageously, the impact of remote programming on the useful life of the patient remote is minimal (e.g., running 10 sessions of 20 minutes each uses approximately 20% or less of the battery energy of the patient remote).

[0097] In system setup 600, the first relay device is a dedicated patient remote control 610, which can communicate with either an IPG 601 having a rechargeable battery or an IPG 602 having a non-rechargeable battery using a first type of communication (e.g., MedRadio). The patient remote control 610 is specially configured for a second type of communication (e.g., Bluetooth) for communication with a second relay device of a patient device 620 (e.g., a patient's laptop, tablet, smartphone). This second relay device wirelessly communicates with a programming device 630 and / or a remote database portal 640 connected to a database 650, which contains various types of data related to the patient's treatment, such as 1) patient program history, 2) device event logs, and 3) patient bladder diary. The communication between the patient device 620 and the remote programming device 630 can be a third type of communication (e.g., cellular, 4G, 5G, Wifi, or any combination thereof) and can further include phone calls, video calls, or text exchanges between the clinician and the patient. Optionally, the patient device 620 can further communicate with the patient database portal 640, which can be accessed via a dedicated application on a smartphone or via a standard web browser on the patient device. The patient device 620 can exchange information (e.g., upload and download) from the patient database portal 640 as needed for reprogramming. In other embodiments, the remote programming device 630 can directly exchange information with the patient database portal and notify of remote programming. The remote programming device 630 can be a standard computing device (e.g., a commercially available tablet or smartphone) equipped with dedicated application software or a dedicated device. Similarly, the patient device 620 can be a standard computing device (e.g., a commercially available tablet or smartphone) equipped with dedicated application software or a dedicated device.

[0098] Figure 23 shows setup 700, in which either of IPGs 701, 702 can communicate locally with patient device 720 via a first type of communication (e.g., Bluetooth). Similar to the setups described above, patient device 720 can communicate remotely with remote programming device 730 and / or patient database portal 740 via a second type of communication (e.g., cellular, 4G, 5G, WiFi, or any combination thereof), and the patient database portal is connected to database 750, which includes various types of data related to the patient's treatment, such as 1) patient program history, 2) device event log, and 3) patient bladder diary. The setup can facilitate remote programming using dedicated application software on patient device 720 and remote programming device 730, and any of a phone call, video call, or text exchange can be used. This setup can utilize Bluetooth and Wifi, which are existing smartphone / tablet communication functions, and may include enabling the Bluetooth function on current patient remote devices. In some exemplary embodiments, patient device 720 hosts a bladder diary application and updates patient database portal 740 with therapy information. In some exemplary embodiments, this setup does not have backward compatibility with legacy IPGs that do not have a Bluetooth function. In some exemplary embodiments, patient remote control 710 can communicate with the IPG via a first type of communication (e.g., Bluetooth).

[0099] FIG. 24 shows a setup 800, which has a configuration and compatibility that are substantially the same as or similar to those of setup 700 and includes IPGs 801, 802 that communicate locally with a patient device 820 by a first type of communication (e.g., Bluetooth). In this embodiment, since the IPG communicates directly with the patient device 820, the function of the patient remote control can be incorporated into the patient device 820, for example, by a dedicated software application (e.g., a patient remote control app), and this dedicated software application can be configured to adjust the stimulation or select any one of a plurality of stimulation programs. This application can be separate from a remote programming application (e.g., IPG communication software) that enables communication between the remote programming device 830 and the IPG via the patient device 820. In addition to a patient database portal 840 connected to a database 850 containing various types of data regarding the patient's treatment, such as 1) patient program history, 2) device event logs, and 3) patient bladder diaries, this setup can similarly include the configuration in option 2A regarding the use of telephone / video call / text exchanges.

[0100] Figure 25 shows setup 900, which includes custom patient device 920, which is a combined patient remote control and relay device for remote programming. In some exemplary embodiments, patient device 920 may be configured for communication by a first type of communication (e.g., MedRadio) to communicate with IPGs 901, 902, and / or may be configured for communication by a second type of communication (e.g., cellular, WiFi) to communicate with remote programming device 930 and / or patient database portal 940. Database portal 940 is connected to database 950 that includes various types of data regarding a patient's treatment, such as 1) patient program history, 2) device event log, and 3) patient bladder diary. In some exemplary embodiments, custom patient device 920 may be configured for local communication by MedRadio and remote communication by WiFi, cellular, or any combination thereof. In this embodiment, since the IPG can communicate directly with patient device 920, the functions of an existing patient remote control can be incorporated into patient device 920 by a dedicated application for, e.g., adjusting stimulation or selecting any of a plurality of stimulation programs. Thus, this approach has backward compatibility with existing IPGs that communicate with a dedicated patient remote control via a first type of communication (e.g., MedRadio). However, this setup requires that custom patient device 920 be configured for communication by both the first type of communication and the second type of communication in order to function as a relay device for remote programming. Advantageously, according to this approach, a separate patient remote control is not needed, thus reducing operating system maintenance issues and potentially requiring fewer updates. This setup includes substantially the same or similar configuration as in the setup described above with respect to the use of phone / video / text communication for reprogramming, the patient database portal, and the patient device functioning as a relay device for remote programming by remote programming device 930.In some exemplary embodiments, the setup enables self-programming of the IPG by the patient device 920 using the patient portal 940.

[0101] FIG. 26 shows setup 1000, which includes personal patient device 1020 (e.g., a patient's personal standard smartphone / tablet), and personal patient device 1020 has one or more dedicated software applications such that the device functions as a combined patient remote control and relay device for remote programming. In this example, patient device 1020 is the patient's personal device and is coupled with communication adapter 1060 accessory (e.g., a plug-in accessory or a wireless accessory; see FIGS. 15A - 15B) to facilitate communication via a first type of communication (e.g., MedRadio, which is not native to the device) and enable communication with IPGs 1001, 1002. Native communication of patient device 1020 via a second type of communication (e.g., cellular, WiFi) can be used to communicate with remote programming device 1030 and / or patient database portal 1040, and database portal 1040 is connected to database 1050, which includes various types of data related to the patient's treatment, such as 1) patient program history, 2) device event log, and 3) patient bladder diary. In this embodiment, since the IPG can communicate directly with patient device 1020, the patient remote control functionality can be incorporated into patient device 1020 by a dedicated application, for example, to adjust stimulation or select any of a plurality of stimulation programs. Thus, this approach has backward compatibility with conventional systems that use an IPG to communicate with a dedicated patient remote control via a first type of communication (e.g., MedRadio). This setup is advantageous as it further eliminates the need for a custom dedicated relay device and enables the use of the patient's own personal device (e.g., smartphone / tablet) for both patient remote control functionality and remote programming.This setup, in other respects, includes a configuration that is substantially the same as or similar to the configuration in the above-described setup, with respect to a patient device that functions as a relay device for telephone / video / text communication functions for reprogramming, a patient database portal, and remote programming by a remote programming device 1030, or as a self-programming device using a patient portal 1040. In some exemplary embodiments, the setup enables self-programming of an IPG by a patient device 1020 using a patient portal 1040.

[0102] Figures 22-26 illustrate various aspects / configurations related to each of the above options. These aspects highlight how each proposed setup can be incorporated into existing systems and devices to leverage existing functionality, in addition to the effects and advantages related to modified, custom, or new devices. For example, the option of using an existing IPG can be implemented within current patients in whom an existing (BT-incompatible) IPG is already implanted, whereas other setup options can be implemented within a latest nerve stimulation system implanted in new patients. These configurations are illustrative, and it is understood that variations of each option, or other options not illustrated, can be implemented. For example, a setup using direct communication between a patient device and an IPG can additionally include a patient remote control redundantly, providing the patient with additional flexibility according to additional options and user preferences. Although various configurations are described as being performed by a device provider, i.e., the "provider" (e.g., Axonics), it is understood that this term can alternatively refer to any customer service, person in charge of a clinical care team. It is understood that each of the listed functions can be utilized in any suitable compatible manner in different setup options.

[0103] FIG. 27 shows an exemplary programming method that establishes a remote programming communication session between an IPG of a nerve stimulation system implanted in a patient and a remote device associated with a remote support entity via one or more relay devices local to the patient, and receives program information from the remote device via the one or more local relay devices, the program information including a current therapy program. Next, the method includes establishing communication between the remote device and a web-based patient database portal pre-updated with therapy information received from the one or more relay devices, receiving the therapy information at the remote device from the patient database portal, and determining or receiving at the remote device a program update regarding an update of one or more parameters of the current program or a new program applied by the implanted nerve stimulation system based on the program information and the therapy information. Finally, the method includes programming the IPG at the remote device with the updated program or the new program via the one or more relay devices.

[0104] Figure 28 shows another exemplary method of remote programming using one or more relay devices. This method may include establishing a remote programming communication session between an IPG of a nerve stimulation system implanted in a patient and a remote device associated with a remote support entity via one or more relay local devices, and receiving current program information from the IPG at the remote device. Optionally, this method may include establishing communication between a patient database portal pre-updated with therapy information via one or more local relay devices, and receiving therapy information at the remote device. In some exemplary embodiments, the one or more local relay devices comprise any of the following: (i) a patient remote control having MedRadio (MR) communication and Bluetooth (BT) communication, and a patient smartphone / tablet having Bluetooth communication and cellular communication, and / or, Wifi communication; (ii) a patient smartphone or tablet having BT communication for a BT-compatible IPG (and optionally a BT-compatible patient remote control); (iii) a custom patient device composed of MR for communication with the IPG and BT for communication with the remote device / patient portal; (iv) a standard smartphone / tablet having a dedicated application providing patient remote control functionality and remote programming functionality, built-in communication means (WiFi / cellular), and an adapter accessory for providing MR for communication with the IPG. Additionally, this method involves determining or receiving at the remote device a program update regarding an update of one or more parameters of the current program, or a new program applied by the implanted nerve stimulation system, based on the program information and the therapy information, and programming the IPG at the remote device via one or more relay devices with the updated program or the new program.

[0105] In the foregoing specification, although various embodiments have been described, those skilled in the art will understand that the present invention is not limited thereto. The various configurations, embodiments, and aspects disclosed may be used individually or in combination. Further, the described embodiments may be utilized in any number of environments and applications other than those described herein, without departing from the broader spirit and scope of this specification. Accordingly, the specification and drawings are to be regarded as illustrative rather than restrictive. It will be understood that the terms "comprising," "including," and "having" as used herein are particularly intended to be read as non-limiting technical terms. References to publications, patents, or patent applications are incorporated herein by reference in their entirety for all purposes.

[0106] (Appendix) (Appendix 1) A method for remotely programming an implanted nerve stimulation system, comprising: establishing a communication session between an implantable pulse generator of a nerve stimulation system, implanted in a patient and configured to supply electrical stimulation pulses to the patient, and a remote programming device associated with a remote support entity via one or more relay local devices of the patient; receiving, at the remote device, program information via the one or more local relay devices, the program information including a current therapy program related to the electrical stimulation pulses applied to the patient by the implanted nerve stimulation system, the one or more local relay devices including a patient device having a user interface; receiving, at the remote device, therapy information from a web-based portal, the therapy information having been remotely pre-received by the web-based portal from the one or more local relay devices; Determining or receiving at the remote device a program update regarding an update of one or more parameters of the electrical stimulation pulses associated with the current therapy program, the update being based on the program information and therapy information Applying the program update to the nerve stimulation system, thereby changing the one or more parameters of the electrical stimulation pulses associated with the current therapy program provided to the patient A method comprising:

[0107] (Appendix 2) The method according to Appendix 1, wherein the therapy information is stored on a patient database and includes any one of a patient program history, a device event log of the implantable pulse generator, and a patient bladder diary

[0108] (Appendix 3) The method according to Appendix 1, wherein the therapy information is received from the patient device by the web-based portal and is remotely updated periodically by the patient device

[0109] (Appendix 4) The method according to Appendix 1, wherein the one or more relay devices include a first relay device and a second relay device, the first relay device includes a patient remote control that communicates with the implantable pulse generator for adjustment of the stimulation level by the patient, and the second relay device is the patient device, and the patient device includes a tablet or smartphone of the patient configured to communicate with each of the patient remote control and the remote device of the remote support entity

[0110] (Appendix 5) The method according to Appendix 4, wherein the patient remote control is configured to communicate with the implantable pulse generator by a first type of communication and communicate with the second relay device by a second type of communication

[0111] (Appendix 6) The method according to appendix 5, wherein the first type of communication is MedRadio and the second type of communication is Bluetooth.

[0112] (Appendix 7) The method according to appendix 4, wherein the second relay device is configured to communicate with the remote device and the web-based portal by means of remote communication.

[0113] (Appendix 8) The method according to appendix 7, wherein the remote communication is either cellular or WiFi, or any combination thereof.

[0114] (Appendix 9) The method according to appendix 8, wherein the remote device is arranged further away from the pulse generator than the first relay device and the second relay device.

[0115] (Appendix 10) The method according to appendix 1, wherein the patient device is configured to communicate locally with the implantable pulse generator and remotely with the remote device of the remote support entity and / or the patient portal database.

[0116] (Appendix 11) The method according to appendix 10, wherein the implantable pulse generator is Bluetooth-compatible and the patient device is a smartphone or tablet that communicates locally with the implantable pulse generator via Bluetooth.

[0117] (Appendix 12) The method according to appendix 10, further comprising adjusting one or more parameters of the current therapy by means of a patient remote control configured to communicate with the implantable pulse generator via Bluetooth.

[0118] (Appendix 13) The method according to Appendix 11, wherein the smartphone or tablet includes a dedicated software application that enables the patient device to operate as the relay device for remote programming and also provides a function to operate as a patient remote control for adjusting therapy stimulation.

[0119] (Appendix 14) The method according to Appendix 1, wherein the patient device is a customized device that communicates locally and directly with the implantable pulse generator through a first type of communication and communicates remotely with the remote device and / or a web-based portal through a second type of communication.

[0120] (Appendix 15) The method according to Appendix 14, wherein the first type of communication is MedRadio and the second type of communication is cellular, WiFi, or a combination thereof.

[0121] (Appendix 16) The method according to Appendix 1, wherein the patient device is communicably coupled to an adapter accessory that provides a first type of communication for communicating with the implantable pulse generator, and the patient device has built-in communication means for a second type of communication.

[0122] (Appendix 17) The method according to Appendix 16, wherein the first type of communication is MedRadio and the second type of communication is cellular, WiFi, or a combination thereof.

[0123] (Appendix 18) The method according to Appendix 16, wherein the patient device is a standard smartphone or tablet of the patient, and a dedicated software for operating as a patient remote control for adjusting stimulation and operating as the relay device for remote programming is stored in the smartphone or tablet.

[0124] (Appendix 19) The method according to appendix 18, wherein the adapter accessory is electrically connected to the patient device or wirelessly connected to the patient device by Bluetooth.

[0125] (Appendix 20) The method according to appendix 1, further comprising the step of self-programming by the patient device by determining or receiving from the web-based portal a program update regarding an update of one or more parameters of the current program applied by the implanted nerve stimulation system based on the program information and the therapy information received by the web-based portal.

[0126] (Appendix 21) A remote programming system for remotely programming an implanted nerve stimulation system by a remote support entity, An implantable pulse generator of the nerve stimulation system implanted in a patient, the implantable pulse generator having one or more antennas for wireless communication with one or more external devices, the one or more external devices including one or more relay devices configured to communicate with the implantable pulse generator via local communication and further communicate by remote communication, an implantable pulse generator, A remote programming device associated with the remote support entity, the remote device being configured to communicate with the one or more relay devices by remote communication, the remote device including a user interface for receiving an input from the remote support entity, a remote programming device, A patient database portal, which is a web-based portal having therapy information updated by the one or more relay devices, the patient database portal being accessible by the remote programming device and the one or more relay devices, a patient database portal, A system comprising.

[0127] (Appendix 22) The one or more relay devices include any one of a patient remote control, a patient device, and an adapter accessory, and the system according to Appendix 21.

[0128] (Appendix 23) The one or more relay devices include a patient remote control configured to communicate locally by both MedRadio and Bluetooth, and a patient device that communicates locally by Bluetooth and communicates remotely by cellular and / or WiFi, and the system according to Appendix 21.

[0129] (Appendix 24) The implantable pulse generator is Bluetooth-compatible, and the one or more relay devices include a patient device that communicates locally directly with the implantable pulse generator by Bluetooth and communicates remotely with the remote programming device by cellular, WiFi, or a combination thereof, and the system according to Appendix 21.

[0130] (Appendix 25) The patient device is a standard smartphone or tablet, and has a dedicated software application operable on the smartphone or tablet to facilitate remote programming, and the system according to Appendix 24.

[0131] (Appendix 26) The system according to Appendix 25, further comprising a patient remote control for adjusting the stimulation therapy that communicates with the implantable pulse generator by Bluetooth.

[0132] (Appendix 27) The dedicated software is further configured such that the patient device operates as a patient remote control for communicating with the implantable pulse generator by Bluetooth and adjusting the stimulation therapy, and the system according to Appendix 25.

[0133] (Appendix 28) The one or more relay devices include a custom patient device configured to communicate with the implantable pulse generator via Bluetooth and communicate with the remote programming device via cellular, WiFi, or a combination thereof, the system according to Appendix 21.

[0134] (Appendix 29) The one or more relay devices include a patient device, a patient device having a dedicated software application operable on the patient device to facilitate remote programming, and an adapter accessory communicatively coupled to the patient device to facilitate local communication with the implantable pulse generator, the system according to Appendix 21.

[0135] (Appendix 30) The patient device includes a standard smartphone or tablet having built-in communication for cellular and / or WiFi, and the patient device communicates with the remote programming device via the built-in communication. The accessory device is configured to communicate with the implantable pulse generator via MedRadio, the system according to Appendix 29.

[0136] (Appendix 31) The accessory is a plug-in device that is electrically connected to the patient device or wirelessly connected via Bluetooth, the system according to Appendix 29.

[0137] (Appendix 32) The one or more relay devices include a patient device having a user interface and a dedicated software application configured for self-programming of the implantable pulse generator by the patient device by determining or receiving at the patient device a program update regarding an update of one or more parameters of the current program applied by the implanted nerve stimulation system based on an update received from the patient database portal, the update being based on the program information and therapy information received by the patient database portal, the system according to appended note 21.

[0138] (Appended note 33) A remote programming system for remotely programming an implanted nerve stimulation system by a remote support entity, An implantable pulse generator of an implanted nerve stimulation system implanted in a patient, the implantable pulse generator being configured to apply a therapy program related to electrical stimulation pulses supplied to the patient, the implantable pulse generator having one or more antennas for wireless communication with one or more external devices, the one or more external devices including one or more relay devices configured to communicate with the implantable pulse generator via local communication, the one or more relay devices being further configured to communicate by remote communication, the implantable pulse generator; A remote programming device associated with the remote support entity, the remote device being configured to communicate with the one or more relay devices by the remote communication, the remote device including a user interface for receiving an input from the remote support entity, the remote programming device being configured to update the therapy program by changing one or more parameters of the electrical stimulation pulses via the one or more relay devices, the remote programming device; A system comprising.

[0139] (Appendix 34) The one or more relay devices include any one of a patient remote control, a patient device, and an adapter accessory, and the system according to Appendix 33.

[0140] (Appendix 35) The one or more relay devices include a patient remote control configured to communicate locally by both MedRadio and Bluetooth, and a patient device that communicates locally by Bluetooth and communicates remotely by cellular and / or WiFi, and the system according to Appendix 33.

[0141] (Appendix 36) The implantable pulse generator is Bluetooth-compatible, and the one or more relay devices include a patient device that communicates locally directly with the implantable pulse generator by Bluetooth and communicates remotely with the remote programming device by cellular, WiFi, or a combination thereof, and the system according to Appendix 33.

[0142] (Appendix 37) The system according to Appendix 33 further includes a patient remote control for adjusting the stimulation therapy that communicates with the implantable pulse generator by Bluetooth.

[0143] (Appendix 38) The one or more relay devices include a custom patient device configured to communicate with the implantable pulse generator by Bluetooth and communicate with the remote programming device by cellular, WiFi, or a combination thereof, and the system according to Appendix 33.

[0144] (Appendix 39) The one or more relay devices include a patient device having a dedicated software application operable on the patient device to facilitate remote programming, and an adapter accessory communicatively coupled to the patient device and facilitating local communication with the implantable pulse generator, the system of claim 33.

Claims

Claim 1 A method for remotely programming an implanted nerve stimulation system, comprising: establishing a communication session between an implantable pulse generator of a nerve stimulation system, implanted in a patient and configured to supply electrical stimulation pulses to the patient, and a remote programming device associated with a remote support entity, via one or more relay local devices of the patient; receiving, at the remote device, program information via the one or more local relay devices, the program information including a current therapy program related to the electrical stimulation pulses applied to the patient by the implanted nerve stimulation system, the one or more local relay devices including a patient device having a user interface; receiving, at the remote device, therapy information from a web-based portal, the therapy information having been remotely pre-received by the web-based portal from the one or more local relay devices; determining or receiving, at the remote device, a program update regarding an update of one or more parameters of the electrical stimulation pulses related to the current therapy program, the update being based on the program information and the therapy information; applying the program update to the nerve stimulation system, thereby changing the one or more parameters of the electrical stimulation pulses related to the current therapy program provided to the patient. A method as described above. Claim 2 The method according to claim 1, wherein the therapy information is stored on a patient database and includes any one of a patient program history, a device event log of the implantable pulse generator, and a patient bladder diary. Claim 3 The method according to claim 1, wherein the therapy information is received by the web-based portal from the patient device and is remotely updated by the patient device periodically. Claim 4 The one or more relay devices include a first relay device and a second relay device, the first relay device includes a patient remote control that communicates with the implantable pulse generator for adjusting a stimulation level by a patient, the second relay device is the patient device, and the patient device includes the patient's tablet or smartphone configured to communicate with each of the patient remote control and the remote device of the remote support entity. The method according to claim 1.

5. The patient remote control is configured to communicate with the implantable pulse generator by a first type of communication and communicate with the second relay device by a second type of communication. The method according to claim 4.

6. The first type of communication is MedRadio, and the second type of communication is Bluetooth. The method according to claim 5.

7. The second relay device is configured to communicate with the remote device and the web-based portal by remote communication. The method according to claim 4.

8. The remote communication is either cellular or WiFi, or any combination thereof. The method according to claim 7.

9. The remote device is disposed farther from the pulse generator than the first relay device and the second relay device. The method according to claim 8.

10. The patient device is configured to communicate locally with the implantable pulse generator and communicate remotely with the remote device of the remote support entity and / or the patient portal database. The method according to claim 1.

11. The implantable pulse generator is Bluetooth-compatible, and the patient device is a smartphone or tablet that communicates locally with the implantable pulse generator by Bluetooth. The method according to claim 10.

12. The method according to claim 10 further includes adjusting one or more parameters of the current therapy by a patient remote control configured to communicate with the implantable pulse generator by Bluetooth.

13. The method according to claim 11, wherein the smartphone or tablet includes a dedicated software application that enables the patient device to operate as the relay device for remote programming and provides a function to operate as a patient remote control for adjusting therapy stimulation.

14. The method according to claim 1, wherein the patient device is a customized device that communicates locally and directly with the implantable pulse generator by a first type of communication and communicates remotely with the remote device and / or a web-based portal by a second type of communication.

15. The method according to claim 14, wherein the first type of communication is MedRadio and the second type of communication is cellular, WiFi, or a combination thereof.

16. The method according to claim 1, wherein the patient device is communicatively coupled to an adapter accessory that provides a first type of communication for communicating with the implantable pulse generator, and the patient device has built-in communication means for a second type of communication.

17. The method according to claim 16, wherein the first type of communication is MedRadio and the second type of communication is cellular, WiFi, or a combination thereof.

18. The method according to claim 16, wherein the patient device is a standard smartphone or tablet of the patient, and the smartphone or tablet stores dedicated software for operating as a patient remote control for adjusting stimulation and operating as the relay device for remote programming.

19. The method according to claim 18, wherein the adapter accessory is electrically connected to the patient device or wirelessly connected to the patient device by Bluetooth.

20. The method according to claim 1, further comprising the step of self-programming by the patient device by determining or receiving from the web-based portal a program update regarding an update of one or more parameters of the current program applied by the implanted nerve stimulation system based on the program information and the therapy information received by the web-based portal.

21. A remote programming system for remotely programming an implanted nerve stimulation system by a remote support entity, an implantable pulse generator of the nerve stimulation system implanted in a patient, the implantable pulse generator having one or more antennas for wireless communication with one or more external devices, the one or more external devices including one or more relay devices configured to communicate with the implantable pulse generator via local communication and further communicate by remote communication, an implantable pulse generator, and a remote programming device associated with the remote support entity, the remote device being configured to communicate with the one or more relay devices by remote communication, the remote device including a user interface for receiving input from the remote support entity, a remote programming device, and a patient database portal that is a web-based portal having therapy information updated by the one or more relay devices, the patient database portal being accessible by the remote programming device and the one or more relay devices, a patient database portal, and comprising a system.

22. The system according to claim 21, wherein the one or more relay devices include any one of a patient remote control, a patient device, and an adapter accessory.

23. The system according to claim 21, wherein the one or more relay devices include a patient remote control configured to communicate locally by both MedRadio and Bluetooth, and a patient device configured to communicate locally by Bluetooth and remotely by cellular and / or WiFi.

24. The system according to claim 21, wherein the implantable pulse generator is Bluetooth-compatible, and the one or more relay devices include a patient device that communicates locally directly with the implantable pulse generator by Bluetooth and remotely with the remote programming device by cellular, WiFi, or a combination thereof.

25. The system according to claim 24, wherein the patient device is a standard smartphone or tablet having a dedicated software application operable on the smartphone or tablet to facilitate remote programming.

26. The system according to claim 25, further comprising a patient remote control for adjusting the stimulation therapy, which communicates with the implantable pulse generator via Bluetooth.

27. The system according to claim 25, wherein the dedicated software is further configured such that the patient device communicates with the implantable pulse generator via Bluetooth and operates as a patient remote control for adjusting the stimulation therapy.

28. The system according to claim 21, wherein the one or more relay devices include a custom patient device configured to communicate with the implantable pulse generator via Bluetooth and communicate with the remote programming device via cellular, WiFi, or a combination thereof.

29. The system according to claim 21, wherein the one or more relay devices include a patient device having a dedicated software application operable on the patient device to facilitate remote programming, and an adapter accessory communicatively coupled to the patient device to facilitate local communication with the implantable pulse generator.

30. The system according to claim 29, wherein the patient device includes a standard smartphone or tablet having built-in communication for cellular and / or WiFi, and the patient device communicates with the remote programming device via the built-in communication, and the accessory device is configured to communicate with the implantable pulse generator via MedRadio.

31. The system according to claim 29, wherein the accessory is a plug-in device that is electrically connected to the patient device or wirelessly connected via Bluetooth.

32. The patient device includes a dedicated software application configured for self-programming of the implantable pulse generator by the patient device, which determines or receives at the patient device a program update regarding an update of one or more parameters of the current program applied by the implantable nerve stimulation system based on an update received from the user interface and the patient database portal, wherein the update is based on the program information and therapy information received by the patient database portal. The system according to claim 21.

33. A remote programming system for remotely programming an implanted nerve stimulation system by a remote support entity, An implantable pulse generator of an implanted nerve stimulation system in a patient, the implantable pulse generator being configured to apply a therapy program related to an electrical stimulation pulse supplied to the patient, the implantable pulse generator having one or more antennas for wireless communication with one or more external devices, the one or more external devices including one or more relay devices configured to communicate with the implantable pulse generator via local communication, the one or more relay devices being further configured to communicate by remote communication. An implantable pulse generator, A remote programming device associated with the remote support entity, the remote device being configured to communicate with the one or more relay devices by the remote communication, the remote device including a user interface for receiving an input from the remote support entity, the remote programming device being configured to update the therapy program by changing one or more parameters of the electrical stimulation pulse via the one or more relay devices. A remote programming device, A system comprising.

34. The system according to claim 33, wherein the one or more relay devices include any one of a patient remote control, a patient device, and an adapter accessory.

35. The system of claim 33, wherein the one or more relay devices include a patient remote configured to communicate locally by both MedRadio and Bluetooth, and a patient device configured to communicate locally by Bluetooth and remotely by cellular and / or WiFi.

36. The system of claim 33, wherein the implantable pulse generator is Bluetooth-compatible, and the one or more relay devices include a patient device configured to communicate locally and directly with the implantable pulse generator by Bluetooth and remotely with the remote programming device by cellular, WiFi, or a combination thereof.

37. The system of claim 33, further comprising a patient remote for adjusting a stimulation therapy, the patient remote communicating with the implantable pulse generator by Bluetooth.

38. The system of claim 33, wherein the one or more relay devices include a custom patient device configured to communicate with the implantable pulse generator by Bluetooth and with the remote programming device by cellular, WiFi, or a combination thereof.

39. The system of claim 33, wherein the one or more relay devices include a patient device having a dedicated software application operable on the patient device to facilitate remote programming, and an adapter accessory communicatively coupled to the patient device to facilitate local communication with the implantable pulse generator.

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