System and method for aligning charger of implanted medical device

Abstract

Devices, systems, and methods for improving alignment of a charging device with an implanted medical device are disclosed herein. The system may include an external charging device that communicates, during charging, one or more charging parameters to a user device having an alignment feature embodied in a software application that displays a real-time charging efficiency indicator based on the charging parameters. The alignment feature allows the optimal location to be determined by observing the charging efficiency while moving the charging device during charging. The applications and devices may be configured to be used by experts, such as representatives of field technicians or device providers, to assist the patient. The system may also include a charging device configured for use with the application and having an additional charging function. The alignment feature may be included for training and / or addressing charging alignment issues experienced by certain patients.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 340,827, filed on May 11, 2022, entitled “Implanted Medical Device Charger Alignment Tools and Methods for Use, Training, and Trouble Shooting,” the entire contents of which are incorporated herein by reference for all purposes.

[0002] This application is also generally related to U.S. non-provisional application No. 17 / 522,644, filed on November 9, 2021, entitled “Devices and Methods for Fine-Tuning Alignment of Charging Device with Implanted Medical Device,” which is assigned to the same assignee and the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present application relates to implantable neural stimulation therapy systems and associated charging devices and methods. Background Art

[0004] The popularity of the use of medical devices in treating diseases has increased over time. In many cases, and as these medical devices are made smaller, these medical devices are often implanted in patients. In order to power such devices, an external charging device is used to power the implanted device or recharge the rechargeable battery of the implanted device, and the external charging device transfers energy to the implanted device transcutaneously. Such external charging devices generally utilize charging coils that are inductively coupled to the internal coils of the implanted medical device. Efficient transcutaneous transfer of energy requires that these coils be properly aligned. Misalignment may result in failure to recharge, inefficient recharging, and / or excessive heating. Although some conventional systems include features for indicating alignment, these features generally only indicate when the alignment is suitable for charging within acceptable limits, and generally cannot achieve precise placement to ensure optimal charging. This may result in suboptimal alignment, which results in extended recharging time and / or excessive heating. In addition, current methods for indicating alignment generally lack detailed guidance for facilitating patients or clinicians to provide precise alignment.

[0005] Therefore, there is a need for devices, systems and methods that facilitate improved precision alignment between an external charging device and an implanted medical device. There is also a need for a method that provides guidance for improved alignment in an intuitive, interactive manner that leverages features of existing systems. Summary of the invention

[0006] In one aspect, the present invention relates to charging an implantable pulse generator via an external charging device, and in particular to devices and methods for improving alignment between a charging coil of an implanted medical device and an external charging device.

[0007] In some embodiments, the system is configured so that the device determines an alignment indicator based on a charging efficiency determined according to one or more charging parameters. The alignment indicator can be an output of real-time charging efficiency during charging. The system outputs an indicator corresponding to the alignment during charging. Typically, the indicator indicates alignment without modifying the charging operation based on the alignment determination. The indicator facilitates precise adjustment of the alignment by the patient or clinician during the charging operation. In one aspect, the alignment features described herein can be incorporated into a user device of an expert (e.g., a field technician associated with a device manufacturer, a clinical care expert) to allow an expert to assist a physician and / or a patient to position the device. Such features are particularly advantageous for training after initial implantation and for solving alignment problems experienced by some patients. In some embodiments, the alignment feature can be embodied in a software application that is accessible / authorized for use only by an expert rather than by a patient, a treating physician, or a clinician device. In some embodiments, the alignment tool includes a user device having a dedicated software application on the user device and configured to be used with a standard charging device or a dedicated charging device with additional functionality. These aspects can be applied to any embodiment described herein.

[0008] In some embodiments, the system includes a first indicator indicating first-order alignment (coarse alignment) corresponding to when the alignment between the coils is sufficient to transfer energy inductively for transcutaneous charging, and a second indicator indicating second-order alignment (fine alignment) within a suitable alignment position range to facilitate fine-tuning adjustments of the alignment to improve charging efficiency and reduce charging time. In some embodiments, the system may include a third indicator indicating when the optimal alignment position is reached. The first indicator, the second indicator, and the third indicator are different from each other so that the user and / or clinician can easily distinguish each indicator.

[0009] The alignment between the charging device and the implanted device can be considered to be first order or second order. In some embodiments, the charging device includes certain indicators for indicating first order alignment (i.e., rough alignment) so that the user can determine whether the initial placement is suitable for establishing inductive coupling and starting charging, and certain other alignment indicators are used to indicate precise or second order alignment (e.g., fine alignment during charging to improve or optimize charging). Typically, the loss of first order alignment loses inductive coupling, which stops charging completely, while the loss of precise or second order alignment reduces charging efficiency / optimization during charging. In some embodiments, the certain other alignment indicators are indicators provided by the charging device that are easily distinguished from the first order indicators. In some embodiments, the certain other alignment indicators are provided by an external user device (e.g., a smart phone, a tablet device) of the patient or clinician. The certain other alignment indicators can be determined and output by a dedicated software application on a standard user device dedicated to improving the alignment of the charging device. In some embodiments, the certain other indicators for second order alignment are provided only by the user device. In some embodiments, the charging device includes a first order alignment indicator, and the user device includes indicators for both first order alignment and second order alignment.

[0010] In some embodiments, an alignment indicator is determined during a standard charging operation and is output to a user (e.g., an expert, patient, and / or clinician) in real time during charging to allow the user to dynamically adjust the alignment of the charging device based on the indicator. In some embodiments, the alignment indicator is a charging efficiency indicator from which the user can determine the optimal alignment. The indicator may be incorporated into the charging device, or may be provided by a user interface of one or more external devices. The indicator may include, but is not limited to, any one or any combination of visual, audio, and tactile. In some embodiments, the indicator may be provided on multiple devices or across multiple devices, for example, the indicator may be provided on both clinician and patient devices, for example, a first indicator may be provided by the charging device, and a second and / or third indicator may be provided on one or more external computing devices of the patient or clinician. This allows additional functionality regarding precise placement to supplement existing charging devices that already have minimal alignment features.

[0011] In some embodiments, the external charging device includes a power button and one or more visual indicators, such as, but not limited to, one or more light indicators (e.g., flashing, on, off) and one or more audio indicators (e.g., one or more tones / beeps). The light indicator may be used to indicate, but not limited to, any of a power-on state (e.g., green on), a battery state of the external device (e.g., orange, flashing orange), an error state (e.g., red), and a charging state (e.g., flashing green). In some embodiments, the charging device charges the implanted medical device in a closed-loop charging state during standard charging, and in an open-loop charging state when the implanted medical device battery is too low to perform closed-loop charging, and may optionally include various other charging states (e.g., slow charging, fast charging, etc.). In some embodiments, any indicator of the charging device indicating charging does not identify or distinguish between different charging states. The audio indicator may be used to indicate any of an initial alignment suitable for starting charging (e.g., a long tone), charging completion (e.g., three ascending tones), and an error state. In some embodiments, the external charging device includes a tactile indicator for indicating changes in charging status that require user intervention (e.g., first-order misalignment, loss of charging coupling). This is particularly advantageous when the implanted medical device is implanted in the lower back / upper buttocks area where the patient cannot observe the visual indicators on the charging device. This implant area is common in sacral neuromodulation systems for treating urinary incontinence and / or fecal incontinence. The use of tactile features for loss of alignment / charging promotes the patient to respond immediately to correct / realign the charging device to resume charging. It is worth noting that conventional devices often rely on various audio and visual indicators (e.g., various patterns of beeps and flashing lights), which may be more easily ignored or confused by the patient, and therefore may cause excessive delays in resuming charging. When the first-order alignment is not appropriate, charging stops completely, so that the implanted medical device may not be charged in the time available to the patient or greatly extend the charging session. Thus, advantageously, this event is indicated by a unique indicator (e.g., tactile vibration) that is immediately recognizable by the patient and easily distinguishable from the categorized beeps / flashes commonly used for various other charging events (e.g., start-up, charging status, battery, completion, etc.) In some embodiments, the charging device includes a tactile indicator only for loss of charge due to misalignment in the first order alignment.

[0012] Further areas 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 intended to necessarily limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1A neurostimulation system according to some embodiments is schematically illustrated, including a clinician programmer for both a trial neurostimulation system and a permanently implanted neurostimulation system.

[0014] Figure 2A-2C A schematic diagram showing neural structures along the spine, lower back, and sacral regions that may be stimulated according to some embodiments.

[0015] Figure 3 An example of a fully implanted neurostimulation system is shown in accordance with some embodiments.

[0016] Figure 4 An example of a neurostimulation system with implantable stimulation leads, an implantable pulse generator, and an external charging device is shown in accordance with some embodiments.

[0017] Figure 5A-5B Shown is a detailed view of an implantable pulse generator and associated components for a neural stimulation system according to some embodiments.

[0018] Figure 6 A schematic diagram illustrating one embodiment of the architecture of an IPG in accordance with some embodiments.

[0019] Figure 7 A schematic diagram illustrating one embodiment of an architecture of a charging device according to some embodiments.

[0020] Figure 8 A schematic diagram showing communications between an IPG and a charging device and alignment indicator according to some embodiments is shown.

[0021] Fig. 9 A schematic diagram illustrating a charging device communicating with an external device having an alignment indicator according to some embodiments.

[0022] Figure 10-11 A schematic diagram illustrating a charging device communicating with an external device having an alignment indicator according to some embodiments.

[0023] Fig.12 A depiction of a charging device with an integrated alignment indicator and position sensor is shown in accordance with some embodiments.

[0024] Figure 13-18 An example screen view of a user device performing fine-tuning of a charging device using a dedicated alignment application is shown in accordance with some embodiments.

[0025] Figure 19-20 An exemplary method of charging an implanted device using a charging device and an alignment indicator is shown in accordance with some embodiments.

[0026] Fig.21A flow chart illustrating the use of a charger alignment tool is shown in accordance with some embodiments.

[0027] Figure 22-24 An exemplary user display screen is shown with a charging alignment indicator shown during charging in accordance with some embodiments.

[0028] Figure 25-28 Exemplary battery and charging information indicators are shown in accordance with some embodiments.

[0029] Fig.29 An exemplary charging alignment tool is shown in accordance with some embodiments and includes an expert user device having a charger alignment application thereon that communicates with a dedicated charging device that charges an implantable medical device.

[0030] Fig.30 An initial login to a charger alignment application is shown for connecting an expert user device to a dedicated charging device in accordance with some embodiments.

[0031] Fig.31 A main display screen of an expert user device is shown on which various charging information indicators for evaluating charger alignment are displayed in accordance with some embodiments.

[0032] Fig.32 Different levels of an exemplary charging efficiency indicator are shown according to some embodiments.

[0033] Fig.33 and 34 Shown is the manner in which a charging device moves during charging while using a charger alignment feature to assess charging alignment, according to some embodiments.

[0034] Fig.35 An exemplary method for optimizing charging device alignment by an expert using a dedicated software application is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0035] The present invention relates to recharging of implanted medical devices, and more particularly, to neurostimulation therapy systems and associated devices. In some embodiments, the present invention relates to charging of an implanted neurostimulator of a sacral neurostimulation therapy system configured to treat overactive bladder ("OAB") and relieve symptoms of bladder-related dysfunction. However, it should be understood that the present invention may also be used for any kind of neuromodulation application (such as fecal dysfunction), treatment of pain or other indications (such as movement or affective disorders), and various other implantable medical devices as understood by those skilled in the art.

[0036] In some embodiments, the present invention relates to a device that obtains one or more charging parameters from a charging device and / or an implantable neurostimulator, and outputs an alignment indicator based on the one or more charging parameters indicating precise alignment between the charging device and the implanted device. Currently, many implantable neurostimulation systems include a receiving coil that receives energy transcutaneously from a charging coil in an external charging device placed on the patient's skin. Exemplary charging devices are described in U.S. Application No. 16 / 816,006 and U.S. Patent No. 10,682,521, the entire contents of which are incorporated herein by reference or for all purposes. Precise alignment between the charging coil and the receiving coil, including alignment along the x and y axes of the patient's skin, as well as rotational orientation, largely determines the efficiency of charging. Typically, conventional systems provide charging as long as the charging device is within a range of suitable positions, however, many positions within the range may provide suboptimal charging with reduced charging efficiency, which may cause patient discomfort and poor charging, as described above. Therefore, various embodiments allow precise placement of the charging device to fine-tune the alignment between the coil of the charging device and the implanted neurostimulator. It should be understood that although the concepts herein are described with respect to a particular type of neurostimulation system, the concepts described herein are applicable to any type of neurostimulation system and also to any charging device for an implanted medical device that would benefit from optimal alignment and placement on a patient. I. Nerve Stimulation Instructions

[0037] Neurostimulation (or neuromodulation, as used interchangeably hereinafter) treatment systems, such as any of the treatment systems described herein, can be used to treat a variety of diseases and related symptoms, such as acute pain disorders, movement disorders, affective disorders, and bladder-related dysfunction. Examples of pain disorders that can be treated by neurostimulation include: failed lumbar surgery syndrome, reflex sympathetic dystrophy or complex regional pain syndrome, causalgia, arachnoiditis, and peripheral neuropathy. Movement disorders include muscle paralysis, tremor, dystonia, and Parkinson's disease. Affective disorders include depression, obsessive-compulsive disorder, cluster headaches, Tourette syndrome, and certain types of chronic pain. Bladder-related dysfunction includes, but is not limited to, OAB, urge incontinence, frequent urination, and urine retention. OAB can include urge incontinence and frequent urination alone or in combination. Urgent incontinence is involuntary urinary incontinence associated with a sudden and strong desire to urinate (urgency). Urgent frequency refers to frequent, usually uncontrollable urges to urinate (urgency), which usually result in small amounts of urination (frequently). Urinary retention refers to the inability to empty the bladder. Neurostimulation therapy may be configured to address a specific disease by achieving neurostimulation of target neural tissue related to sensory and / or motor control associated with the specific disease or related symptoms.

[0038] In one aspect, the methods and systems described herein are particularly suitable for treating urinary and fecal dysfunction. These diseases have historically been under-recognized and under-treated by the medical community. OAB is one of the most common urinary dysfunctions. It is a complex disease characterized by the presence of distressing urinary symptoms, including urgency, frequency, nocturia, and urge incontinence. It is estimated that approximately 33 million Americans suffer from OAB. In the adult population, approximately 30% of all men and 40% of all women suffer from OAB symptoms.

[0039] OAB symptoms can have a significant negative impact on patients’ psychosocial functioning and quality of life. People with OAB often limit activities and / or develop coping strategies. In addition, OAB imposes a significant economic burden on individuals, their families, and healthcare providers. The prevalence of comorbidities in patients with OAB is also significantly higher than in the general population. Comorbidities may include falls and fractures, urinary tract infections, skin infections, vulvovaginitis, cardiovascular, and central nervous system diseases. Chronic constipation, fecal incontinence, and overlapping chronic constipation are more common in patients with OAB.

[0040] Conventional treatment of OAB usually includes lifestyle changes as a first step. Lifestyle changes include eliminating bladder irritants (such as caffeine) from the diet, controlling fluid intake, losing weight, quitting smoking, and controlling bowel regularity. Behavioral changes include changing urination habits (such as bladder training and delayed urination), training the pelvic floor muscles to improve urethral sphincter strength and control, biofeedback, and impulse inhibition techniques. Medications are considered the second line of treatment for OAB. These include anticholinergics (oral, transdermal patches, and gels) and oral beta-3 adrenergic agonists. However, anticholinergics are often associated with bothersome systemic side effects, including dry mouth, constipation, urinary retention, blurred vision, drowsiness, and confusion. Studies have found that more than 50% of patients stop using anticholinergics within 90 days due to lack of benefit, adverse events, or cost. II. Sacral Nerve Modulation

[0041] Sacral Neuromodulation (SNM) is a recognized treatment that provides a safe, effective, reversible and durable treatment option for the treatment of urge incontinence, frequent urination and non-obstructive urinary retention. SNM treatment involves the use of mild electrical pulses to stimulate the sacral nerves located in the lower back. The electrodes are placed next to the sacral nerves, usually at the S3 level, by inserting the electrode leads into the corresponding holes of the sacrum. The electrodes are inserted subcutaneously and then attached to an implantable pulse generator (IPG), which is also referred to herein as an "implantable neurostimulator" or "neurostimulator". The safety and effectiveness of SNM for the treatment of OAB, including five-year durability for patients with urge incontinence and frequent urination, has been supported by multiple studies and has been well documented. SNM is also approved for the treatment of chronic fecal incontinence in patients who have failed or cannot undergo more conservative treatment. A. Implantation of the Sacral Neuromodulation System

[0042] Currently, SNM qualification consists of a trial phase using an external neurostimulator and, if successful, followed by a permanent implant with a fully implantable, rechargeable neurostimulator. The trial phase is a test stimulation period during which the patient is allowed to assess whether the treatment is effective. Typically, there are two techniques for performing test stimulation. The first is an office-based phase known as a Percutaneous Nerve Evaluation (PNE), and the other is a staged trial.

[0043] The mechanism of action of SNM is multifactorial and affects the neural axis at several different levels. In patients with OAB, it is believed that the pudendal afferent nerves can activate inhibitory reflexes that promote bladder storage by inhibiting the afferent limb of the abnormal micturition reflex. This blocks input to the brainstem micturition center, thereby limiting involuntary contractions of the detrusor muscle without interfering with the normal urination pattern. For patients with urinary retention, SNM is believed to activate pudendal nerve afferents originating from the pelvic organs to the spinal cord. At the spinal level, the pudendal afferent nerves can relieve symptoms in patients with urinary retention by inhibiting excessive protective reflexes to turn on the micturition reflex, thereby promoting normal urination. In patients with fecal incontinence, it is hypothesized that SNM stimulates pudendal afferent fibers, inhibits colonic propulsive activity and activates the internal anal sphincter, thereby improving symptoms in patients with fecal incontinence. The present invention relates to a system suitable for delivering neural stimulation to target neural tissue in a manner that destroys, inhibits or prevents neural activity in the target neural tissue so as to provide a therapeutic effect when treating OAB or bladder-related dysfunction. In one aspect, the system is adapted to provide a therapeutic effect through neural stimulation without inducing motor control of muscles associated with OAB or bladder-related dysfunction by the delivered neural stimulation. In another aspect, the system is adapted to provide such a therapeutic effect by delivering subthreshold neural stimulation below the threshold for inducing paresthesias and / or neuromuscular responses, or allowing adjustment of the neural stimulation to deliver subthreshold levels of therapy.

[0044] Sacral neuromodulation applications typically involve implanting an implantable neurostimulator device into the patient's lower back / upper buttock region to provide better access to the sacral nerves through the sacrum (see Figure 3 ). For the patient, such placement of the external charging device may be difficult to observe, making accurate placement (especially over time) frustrating due to the migration and fluctuation of body weight. Although current neurostimulation systems have provided significant improvements in stimulation efficiency, such systems generally require periodic recharging over the device using an external charging device located on the patient. Typically, patients recharge the neurostimulator periodically (such as every few days, weeks, or months), depending on the frequency of use and the level of stimulation for treatment. If the charging device is optimally placed, many implantable neurostimulators can be recharged in less than two hours (usually in one hour or less) with minimal patient discomfort. However, if it is not accurately placed, recharging may take significantly longer, for example, more than one hour, such as three hours or more. In addition, suboptimal placement may result in the accumulation of excessive heat, and prolonged contact of the external charging device may result in considerable annoyance and patient discomfort. Therefore, it is desirable to provide devices and methods that facilitate accurate placement of charging devices as further described below. B. Example Embodiments

[0045] Figure 1 An exemplary neurostimulation system is schematically shown, which includes a trial neurostimulation system 200 and a permanent implant neurostimulation system (INS) 100. The EPG 80 and IPG 10 are each compatible and wirelessly communicated with a clinician programmer 60 and a patient remote control 70, which are used to position and / or program the trial neurostimulation system 200 and / or position and / or program the permanent implant system 100 after a successful trial. As described above, the clinician programmer can include dedicated software, dedicated hardware, and / or both to assist in lead placement, programming, reprogramming, stimulation control, and / or parameter setting. In addition, each of the IPG and EPG allows the patient to have at least some control over the stimulation (e.g., start a preset program, increase or decrease stimulation), and / or monitor battery status with a patient remote control. The method also allows for an almost seamless transition between a trial system and a permanent system.

[0046] The electrical pulses generated by the EPG and IPG are delivered to one or more target nerves via one or more neurostimulation electrodes at or near the distal end of each of the one or more leads. The leads can have various shapes, can have various sizes, and can be made of various materials, and their sizes, shapes, and materials can be customized for specific therapeutic applications. Although in this embodiment, the leads have a suitable size and length to extend from the IPG and pass through one of the holes in the sacrum to reach the target sacral nerve, in various other applications, the leads can be implanted, for example, in a peripheral part of the patient's body, such as in an arm or leg, and can be configured to deliver electrical pulses to peripheral nerves, such as can be used to relieve chronic pain. The leads and / or stimulation programs can vary depending on the target nerves.

[0047] To further improve placement of the charging device on the patient to provide optimal fine-tuned alignment, the system may include an alignment tool which may include an alignment indicator on the user device or the charging device itself that allows the user to observe a real-time indicator of coil alignment during manual positioning of the charging device. In this embodiment, the alignment tool is embodied in a separate expert user device 90 that communicates with a dedicated charging device 95 used to charge the INS 10, which can be used by an expert (e.g., a field technician, a representative of the equipment provider, a clinical care specialist). This alignment feature is particularly useful in sacral nerve stimulation systems such as those described because the implantable pulse generator is implanted in the lower back / upper buttocks region of the patient where it may be difficult for the patient to view placement during manual positioning of the charging device. Figure 1In the embodiment of INS 10, clinician programmer 60 includes an alignment indicator 61 configured to display an alignment indicator that can be used by a clinician to facilitate precise placement of a charging device by viewing one or more charging parameters or associated charging metrics in real time during a charging operation. Alternatively or additionally, the alignment indicator can be provided on an expert user device 90. In this embodiment, the alignment indicator is a charging efficiency indicator 91 based on one or more parameters received from a dedicated charging device 95 during charging of INS 10.

[0048] The implantable permanent system includes a charging device 50, which is configured to transcutaneously charge an implantable pulse generator via an inductively coupled coil. Typically, the implantable pulse generator includes a single receiving coil and the charging device 50 includes a single transmitting coil. When the charging device 50 is placed near the implantable pulse generator, the charging device and the implantable pulse generator establish communication and initiate a charging protocol. When the alignment process is initiated upon receiving a request from an external user device 60, 90, the charging device 50, 95 can output one or more charging parameters to the corresponding user device or utilize an alignment module different from the charging module to determine the charging parameters or alignment metrics and output them to the external user device. The charging device 50, 95 may also include an adhesive attachment device 52 or a charging strap 53 to keep the charging device 50 in position on the patient during charging.

[0049] The clinician programmer 60 includes a control unit, which may include a microprocessor and dedicated computer code instructions for implementing the methods and systems used by the physician in deploying the treatment system and setting treatment parameters. The clinician programmer typically includes a user interface, which may be a graphical user interface and may also include audio and tactile features. The clinician programmer 60 may be configured with a dedicated software application, for example, dedicated alignment software, which determines and outputs an alignment indicator to guide the user in the fine-tuning charging device alignment process. As described above, the clinician programmer may include a module with hardware and computer code to perform an analysis of the charging parameters to determine the charging efficiency, wherein the module may be a component of the control unit microprocessor, a pre-processing unit coupled to or in series with the stimulation and / or sensing cable, and the like. In this embodiment, the clinician program 60 communicates directly with the charging device 50 and obtains one or more charging parameters during charging. The clinician programmer 60 provides an alignment indicator 65, which may be a dynamically updated display of the charging parameters or associated metrics (e.g., charging efficiency) to enable the clinician to observe the intensity of the charging efficiency during manual adjustment of the position of the charging device 50. In one aspect, the charging device is communicatively coupled to the clinician programmer 60 via shortwave radio communication (e.g., Bluetooth) while currently communicating with the implantable pulse generator via another communication scheme (e.g., MedRadio). In some embodiments, the clinician programmer 60 obtains one or more charging parameters from the charging device 50, but does not otherwise modify the charging operation based on the alignment determination. In some embodiments, the alignment indicator 65 may also provide a spatial illustration of the position of the charging device relative to the implantable medical device. In other embodiments, the clinician programmer may utilize various other means for indicating alignment, including but not limited to tactile, visual (e.g., LED, graphic) or audio (e.g., beep or alarm) to indicate optimization of alignment. In some embodiments, the indicator may include a variety of different types of notifications or notifications that change as the charging device is adjusted and approaches optimal placement. An alignment indicator including any of the above features may be incorporated into the charging device itself, or may be provided on another user device, such as a patient's device, such as a patient remote control or a personal computing device (e.g., smart phone, tablet device). Each of the above aspects described with respect to a clinician programmer may be similarly applied to an expert user device 90 , which may communicate with a patient's standard charging device 50 or dedicated charging device 95 .

[0050] Figure 2A-2C Schematic diagram showing various neural structures of a patient that may be used for neurostimulation therapy. Figure 2ADifferent segments of the spinal cord and the corresponding nerves in each segment are shown. The spinal cord is a bundle of elongated nerves and supporting cells, which extends from the brainstem along the cervical spinal cord, passes through the thoracic spinal cord, and reaches the space between the first and second lumbar vertebrae in the lumbar spinal cord. After leaving the spinal cord, the nerve fibers split into multiple branches, which dominate various muscles and organs, and transmit sensation and control impulses between the brain and the organs and muscles. Because some nerves can include branches that dominate certain organs (such as bladder) and branches that dominate certain muscles of the legs and feet, the stimulation of the nerves at or near the nerve roots near the spinal cord can stimulate the nerve branches that dominate the target organs, which can also cause the muscle reactions associated with the stimulation of another nerve branch. Therefore, by vision, using EMG described herein or both to monitor certain muscle reactions simultaneously, the doctor can determine whether the target nerve is stimulated. Although the stimulation of a certain threshold value can trigger the muscle reaction of interest, the stimulation of the subthreshold level can still provide the stimulation of the nerves associated with the target organ without causing corresponding muscle reactions, and in some embodiments, it will not cause any paresthesia. This is advantageous because it allows the condition to be treated through neural stimulation without otherwise causing discomfort, pain or undesirable muscle reactions to the patient.

[0051] Figure 2B Nerves associated with the lower back segments in the lower lumbar region are shown where the nerve bundles exit the spinal cord and pass through the sacral foramen of the sacrum. In some embodiments, a neurostimulation lead is advanced through the sacral foramen until the neurostimulation electrode is positioned over the ventral root of the sacral nerve, with the anchoring portion of the stimulating electrode proximal lead typically disposed on the back of the sacral foramen through which the lead passes to anchor the lead in place. Figure 2C A detailed view of the lumbosacral trunk and sacral plexus is shown, particularly the S1-S5 nerves of the lower sacrum. The S3 sacral nerve has received special attention to treat bladder-related dysfunction, particularly OAB.

[0052] Figure 3 An example of a fully implanted neurostimulation system 110 suitable for sacral nerve stimulation is schematically shown. The neurostimulation system 100 includes an IPG implanted in the lower back region, and the IPG is connected to a neurostimulation lead that extends through the S3 foramen for stimulating the S3 sacral nerve. The lead is anchored by a notched anchoring portion 30 that maintains the position of a set of neurostimulation electrodes 40 along a target nerve (in this example, the ventral root S3 of the sacral nerve) that weakens the bladder to provide treatment for various bladder-related dysfunctions. Although this embodiment is suitable for sacral nerve stimulation, similar systems can be used to treat patients with chronic, severe, refractory neuropathic pain, such as originating from peripheral nerves or various urinary dysfunctions or other indications. The implantable neurostimulation system can be used to stimulate the target peripheral nerve or the posterior epidural space of the spine.

[0053] like Figure 3 As shown, the implantable pulse generator 10 of the INS is implanted in the lower back, upper hip region of the patient. The patient is usually instructed to position the charging device above the scar caused by the incision formed during the implantation of the neurostimulator. However, the location of the scar in the implantation of the sacral neurostimulation system makes this task difficult because the patient cannot easily observe the scar during the placement of the charging device. In addition, in some patients, the position of the neurostimulator may change over time, for example due to weight loss that tends to occur after successful treatment. Therefore, by setting the alignment indicator feature in a user device (such as a clinician programmer, a patient remote control, a patient device, or an expert device), the alignment indicator can be delivered to the user during the manual positioning of the charging device, thereby allowing precise placement without visually observing the position of the IPG. Although the scar may not indicate the proper position of the charging device, the scar can still be used as a reference for the newly determined optimal position (e.g., 2 cm up / 3 cm to the right from the scar), which can be delivered to the patient for subsequent charging sessions.

[0054] The characteristics of the electrical pulses may be controlled via a controller of the implanted pulse generator. In some embodiments, these characteristics may include, for example, the frequency, intensity, pattern, duration, or other aspects of the electrical pulses. These characteristics may include, for example, voltage, current, etc. Such control of the electrical pulses may include creating one or more electrical pulse programs, plans, or patterns, and in some embodiments, this may include selecting one or more pre-existing electrical pulse programs, plans, or patterns. Figure 3 In the embodiment depicted in , the implantable neurostimulation system 110 includes a controller in an IPG having one or more pulse programs, schedules, or patterns that may be pre-programmed or created as discussed above. In some embodiments, these same features associated with the IPG may be used in an EPG of a partially implanted trial system used prior to implantation of the permanent neurostimulation system 110.

[0055] Figure 4An example neurostimulation system 400 is shown that is fully implantable and suitable for sacral nerve stimulation treatment. The implantable system 400 includes an IPG 10 and an internal receiving coil 15 coupled to a neurostimulation lead 20, which includes a set of neurostimulation electrodes 40 at the distal end of the lead. The lead includes a lead anchoring portion 30 having a series of tines that extend radially outward to anchor the lead and maintain the position of the neurostimulation lead 20 after implantation. The lead 20 may also include one or more radiopaque markers 25 to assist in placement and positioning of the lead using visualization techniques such as fluoroscopy. In some embodiments, the IPG provides monopolar or bipolar electrical pulses that are delivered to the target nerve through one or more neurostimulation electrodes (typically four electrodes). In sacral nerve stimulation, the lead is typically implanted through the S3 hole as described herein.

[0056] In one aspect, the IPG is wirelessly recharged by conductive coupling using a charging device 50, which is a portable device powered by a rechargeable battery to allow the patient to move while charging. The charging device includes a charging coil 51, which is disposed inside it and is used to transcutaneously charge the IPG by RF induction. The charging device 50 can be attached to the patient's skin using an adhesive, or can be fixed in place using a strap 53 or an adhesive patch 52. When recharging the IPG 10, the charging device 50 can be fixed in place using a strap 53 or an adhesive patch 52 so that the surface 54 of the charging device 50 contacts the skin through which the IPG 10 is recharged, is parallel to the skin through which the IPG 10 is recharged, and / or is close to the skin through which the IPG 50 is recharged. In such a position, the charging device axis can be perpendicular to the surface 54, and the charging device axis can be perpendicular to the skin through which the IPG 10 is recharged. The charging device 50 may be charged by plugging the charging device directly into an outlet or by placing the charging device in a charging dock or station that is connected to an AC wall outlet or other power source.

[0057] The charging device 50 may include a housing. The housing may include a variety of shapes and sizes. In some embodiments, the housing may be Figure 4 The cylindrical shape shown, and in particular, may include a plurality of connected cylindrical portions, wherein the connected cylindrical portions have different diameters and / or lengths. In some embodiments, the housing 51 may be metal or a polymer, such as plastic or the like.

[0058] The charging device 50 may include a processor and / or memory suitable for providing instructions to and receiving information from other components of the implantable neural stimulation system. The processor may include a microprocessor, such as a or Advanced Micro Devices, The charging device 50 may include an energy storage feature, such as one or more capacitors, and typically includes a wireless charging unit. Figure 7 Some details of the charging device 50 are discussed at greater length. The charging device may also include one or more position sensors, such as accelerometers, for determining the relative position and / or direction of movement of the charging device during repositioning. Any of the above features of the charging device 50 may be shared by the dedicated charging device 95 (see also Figure 29-30 ). Preferably, the dedicated charging device includes a charging coil of the same size, shape and arrangement as the standard charging device 50 , so that any optimal position of the dedicated charging device corresponds precisely to the standard charging device 50 .

[0059] The system may also include a patient remote control 70 and a clinician programmer 60, each configured to communicate wirelessly with an implanted IPG or with an EPG during a trial. The clinician programmer 60 may be a tablet device used by a clinician to program the IPG and EPG. The device also includes the ability to record stimulation-induced electromyograms (ECGs) to facilitate lead placement, programming, and / or reprogramming. The patient remote control may be a battery-operated portable device that communicates with the EPG and IPG using radio frequency (RF) signals and allows the patient to adjust the stimulation level, check the status of the IPG battery level, and / or turn stimulation on or off.

[0060] Figure 5A-5B A detailed view of an IPG and its internal components is shown. 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 cause some other desired effect, such as to inhibit, prevent, or disrupt nerve activity to treat OAB or bladder-related dysfunction. In some applications, the pulses have a pulse amplitude in a range between 0 mA to 1,000 mA, 0 mA to 100 mA, 0 mA to 50 mA, 0 mA to 25 mA, and / or any other range or intermediate range of amplitudes may be used. One or more of the pulse generators may include a processor and / or a memory suitable for providing instructions to and receiving information from other components of the implantable neurostimulation system. The processor may include a microprocessor, such as from or Advanced Micro Devices, etc. An IPG may include energy storage features, such as one or more capacitors, and typically includes a wireless charging unit.

[0061] One or more characteristics of the electrical pulses can be controlled via the controller of the IPG or EPG. In some embodiments, these characteristics may include, for example, the frequency, intensity, pattern, duration or other aspects of the timing and amplitude of the electrical pulses. These characteristics may also include, for example, voltage, current, etc. This control of the electrical pulses may include creating one or more electrical pulse programs, plans or patterns, and in some embodiments, this may include selecting one or more pre-existing electrical pulse programs, plans or patterns. In one aspect, the IPG 10 includes a controller having one or more pulse programs, plans or patterns that can be created and / or pre-programmed. In some embodiments, the IPG may be programmed to change stimulation parameters to achieve optimal patient-specific treatment results, the stimulation parameters including pulse amplitudes in the range of 0mA to 10mA, pulse widths in the range of 50μs to 500μs, pulse frequencies in the range of 5Hz to 250Hz, stimulation modes (e.g., continuous or cyclic) and electrode configurations (e.g., anode, cathode or off). This allows the optimal settings to be determined for each patient, even if each parameter may vary from person to person.

[0062] like Figure 5A-5B As shown, the IPG can include a top portion 11 at one end and a ceramic portion 14 at an opposite end. The top portion 11 houses a feedthrough assembly 12 and a connector stack 13, while the ceramic case portion 14 houses an antenna assembly 16 to facilitate wireless communication with a clinician program, a patient remote control, and / or a charging coil to facilitate wireless charging with a charging device. The remainder of the IPG is covered with a titanium alloy case portion 17, which encapsulates a printed circuit board, memory, and controller assembly that facilitates the above-mentioned electrical pulse program. The ceramic portion 14 includes an end 23, a side 24, and a connecting portion 26 that connects the ceramic portion 14 to the case portion 17. Figure 5B In the example shown, the antenna assembly 16 is positioned so that a plane 28 in which the loop of radiating elements is positioned is perpendicular to and extends through the side 24 of the ceramic portion 14 .

[0063] In some embodiments, such as Figure 5A In the embodiment shown in , a ceramic and titanium alloy brazed housing is used on one end of the IPG, where the ferrite coil and PCB antenna assembly are positioned. A reliable hermetic seal is provided by ceramic-metal brazing technology. The zirconia ceramic may include 3Y-TZP (e.g., 3 mol% yttrium stabilized tetragonal zirconia polycrystalline) ceramic, which has high bending strength and impact resistance and has been commercially used in many implantable medical technologies. However, other ceramics or other suitable materials may be used to construct the IPG, and the ceramic may be used to form additional portions of the housing.

[0064] In one aspect, the use of ceramic materials provides an efficient RF transparent window for wireless communication with external patient remote controls and clinician programmers because the communication antenna is contained within a sealed ceramic housing. The ceramic window further facilitates miniaturization of the implant while maintaining an efficient RF transparent window for long-term and reliable wireless communication between the IPG and external controllers (such as patient remote controls and clinician programmers). Unlike prior art products where the communication antenna is placed in the top outside the sealed housing, the wireless communication of the IPG is generally stable during the life of the device. Due to changes in the dielectric constant of the top material in the human body over time, the communication reliability of such prior art devices tends to decrease.

[0065] On the other hand, the ferrite core is Figure 5B A portion of the charging coil assembly 15 is shown, which is positioned inside the ceramic housing 14. In contrast to the metal housing portion 17, the ferrite core concentrates the magnetic field flux through the ceramic housing. This configuration maximizes coupling efficiency, which reduces the required magnetic field and, in turn, reduces device heating during charging. Specifically, because the magnetic field flux is oriented in a direction perpendicular to the minimum metal cross-sectional area, heating during charging is minimized. This configuration also allows the IPG to be efficiently charged with a charging device at a depth of 3 cm (when positioned on the patient's skin surface close to the IPG) and reduces recharging time.

[0066] Figure 6 A schematic diagram illustrating one embodiment of the architecture of IPG 10 is shown. In some embodiments, each component of the architecture of IPG 10 may be implemented using a processor, memory, and / or other hardware components of IPG 10. In some embodiments, the components of the architecture of IPG 10 may include software that interacts with the hardware of IPG 10 to achieve desired results, and the components of the architecture of IPG 10 may be located within a housing.

[0067] In some embodiments, the IPG 10 may include, for example, a communication module 600. The communication module 600 may be configured to send and receive data to and from other components and / or devices of the exemplary neurostimulation system, including, for example, a clinician programmer 60, a charging device 50, and / or a patient remote control 70. In some embodiments, the communication module 600 may include one or more antennas and software configured to control the one or more antennas to send and receive information to and from one or more other components of the IPG 10. In some embodiments, for example, when connected to the charging device 50, the communication module 600 may be configured to send data identifying the IPG 10 and / or characterizing one or more attributes of the IPG 10. In some embodiments, the information may be, for example, a number that uniquely identifies the IPG 10, such as, for example, a serial number, etc. In some embodiments, the data may characterize one or more attributes of the IPG 10, such as, for example, a natural frequency of a charging module 606 of the IPG 10 and / or a natural frequency of one or more components of the charging module 606 of the IPG. In some embodiments, the IPG 10 may be configured to transmit one or more charging parameters to a user device (including any of a clinician programmer, a patient remote control, or a portable patient computing device) during charging, and an alignment indicator may be provided on the user device based on the one or more charging parameters.

[0068] The IPG 10 may also include a data module 602. The data module 602 may be configured to manage data related to the identity and attributes of the IPG 10. In some embodiments, the data module may include one or more databases, which may, for example, include information related to the IPG 10, such as, for example, an identification of the IPG 10, one or more attributes of the IPG 10, and the like. In one embodiment, data identifying the IPG 10 may include, for example, a serial number of the IPG 10 and / or other identifiers of the IPG 10, including, for example, a unique identifier of the IPG 10. In some embodiments, information associated with the attributes of the IPG 10 may include, for example, data identifying the functionality of the IPG 10, data identifying the power consumption of the IPG 10, data identifying the charging capacity of the IPG 10 and / or the energy storage capacity of the IPG 10, data identifying the potential and / or maximum charging rate of the IPG 10, and the like. In some embodiments, information associated with the attributes of the IPG 10 may include, for example, data identifying the natural frequency of the IPG 10 and / or its components. In some embodiments, this information identifying the natural frequency may be generated when the IPG 10 is manufactured.

[0069] The IPG 10 may include a pulse controller 604. In some embodiments, the pulse controller 604 may be configured to control the generation of one or more pulses by the IPG 10. In some embodiments, for example, this may be performed based on information identifying one or more pulse patterns, programs, and the like. The information may also specify, for example, the frequency of pulses generated by the IPG 10, the duration of pulses generated by the IPG 10, the intensity and / or amplitude of pulses generated by the IPG 10, or any other details related to the creation of one or more pulses by the IPG 10. In some embodiments, the information may specify aspects of the pulse pattern and / or pulse program, such as, for example, the duration of the pulse pattern and / or pulse program, and the like. In some embodiments, information related to and / or used to control the generation of pulses by the IPG 10 may be stored in a memory.

[0070] The IPG 10 may include a charging module 606. In some embodiments, the charging module 606 may be configured to control and / or monitor the charging / recharging of the IPG 10. In some embodiments, for example, the charging module 606 may include one or more features configured to receive energy for recharging the IPG 10, such as, for example, one or more inductive coils / features that may interact with one or more inductive coils / features of the charging device 50 to generate inductive coupling to recharge the IPG 10. In some embodiments, the charging module 606 may include hardware and / or software configured to monitor the charging of the IPG 10, including, for example, a charging coil assembly 15, also referred to herein as a receiving coil assembly 15 or an elongated receiving coil assembly 15. In some embodiments, the software of the charging module may be periodically updated, such as in a software push by an external computing device that communicates with the communication module. Typically, the communication module provides secure authentication of any communication regarding software updates, such that any software updates are transmitted only when secure authenticated communications (e.g., communications from an authorized clinician programmer or communications with an authorization key from a network or remote server) are received.

[0071] The charging module 606 of the IPG 10 may include a charging circuit 607, also referred to herein as a resonant circuit 607, a secondary charging circuit 607, a secondary resonant circuit 607, a receiving charging circuit 607, or a receiving resonant circuit 607. In some embodiments, the charging circuit 607 may include, for example, at least one of the following: an inductor; a capacitor; or a resistor. The charging circuit 607 may be characterized by a natural frequency, which may be determined, for example, at the time of assembly of the charging circuit 607 or after the IPG 10 is implanted in the body. In some embodiments, the natural frequency of the charging circuit 607 may remain constant after the IPG 10 is implanted in the body due to the relatively constant temperature and environment in the body. The IPG 10 may also include an energy storage device 608, which in this embodiment is a rechargeable battery configured to receive charging energy from the charging module 606.

[0072] Figure 7 A schematic diagram of one embodiment of the architecture of the charging device 50 is shown. The features described in the following paragraphs may be similarly applied to the dedicated charging device 95. In some embodiments, each component of the architecture of the charging device 50 may be implemented using a processor, memory, and / or other hardware components of the charging device 50. In some embodiments, the components of the architecture of the charging device 50 may include software that interacts with the hardware of the charging device 50 to achieve a desired result, and the components of the architecture of the charging device 50 may be located within the housing 51.

[0073] In some embodiments, the charging device 50 may include, for example, a communication module 700. The communication module 700 may be configured to send and receive data to and from other components and / or devices of the exemplary neurostimulation system, including, for example, a clinician programmer 60, an IPG 10, and / or a patient remote control 70. In some embodiments, the communication module 700 may include one or more antennas and software configured to control the one or more antennas to send and receive information to and from one or more other components of the charging device 50. In some embodiments, the charging device communicates with the IPG during charging using a first antenna, and transmits one or more charging parameters or associated metrics to a user device via a second antenna. In some such embodiments, the first antenna may communicate with the IPG via MedRadio, while the second antenna communicates with the user device via Bluetooth. In some embodiments, when connected to the IPG 10, the communication module 700 may be configured to receive data identifying the IPG 10 and / or characterizing one or more attributes of the IPG 10. In some embodiments, this information may be, for example, a number that uniquely identifies the IPG 10, such as, for example, a serial number or the like.

[0074] The charging device 50 may also include a data module 702. The data module 702 may be configured to manage data related to the identity and attributes of the IPG 10. In some embodiments, the data module may include one or more databases, which may, for example, include information related to the IPG 10, such as, for example, an identification of the IPG 10, one or more attributes of the IPG 10, and the like. In one embodiment, for example, the data module may include a database including one or more IPG 10 identifiers, such as serial numbers of those one or more IPGs 10. In some embodiments, the data module 702 may also include characterization data associated with some or all of the one or more IPGs 10 identified in the data module 702. In some embodiments, for example, the characterization data may include an identification of a natural frequency of the charging circuit 607 of the IPG 10. In some embodiments, the characterization data may be received from the IPG 10 and / or may be generated by the charging device 50 in response to an interaction with the IPG 10. In some such embodiments, the data module provides for isolation of data, for example, between charging parameters used during charging control and charging parameters sent to a user device. This approach can allow user devices to access data and processes that would not otherwise be feasible or recommended to avoid unauthorized access to charging control operations by patients or clinicians.

[0075] The charging device 50 may include a charging module 704. In some embodiments, the charging module 704 may be configured to control and / or monitor the charging / recharging of the IPG 10. In some embodiments, for example, the charging module 704 may include one or more features configured to provide energy for recharging the IPG 10, such as, for example, one or more inductive coils / features that may interact with one or more inductive coils / features of the IPG 10 to generate inductive coupling to recharge the IPG 10. In some embodiments, the charging module 704 may include hardware and / or software configured to monitor the charging of the IPG 10, which includes, for example, the charging coil assembly 15.

[0076] The charging module 704 of the charging device 50 may include a charging circuit 706, also referred to herein as a resonant circuit 706, a primary charging circuit 706, a primary resonant circuit 706, a transmitter charging circuit 706, or a transmitter resonant circuit 706. In some embodiments, the charging circuit 706 may include, for example, at least one of the following: an inductor; a capacitor; or a resistor. In some embodiments, the resonant circuit 706 may include a transmitting coil assembly, also referred to herein as a transmitting coil assembly or a primary coil assembly.

[0077] In some embodiments, the charging module 704 may include a driver 708. The driver 708 may be, for example, a non-Class E driver, and in some embodiments, the driver 708 may be a Class E driver, and specifically may be a microprocessor-controlled Class E driver as disclosed in U.S. Patent Application No. 14 / 446,294 filed on July 29, 2014, the entire contents of which are incorporated herein by reference. In some embodiments, the driver 708 may be configured to provide electrical pulses to the resonant circuit 706, thereby charging the IPG 10. In some embodiments, the driver 708 may also be configured to provide these pulses at a frequency corresponding to the natural frequency of the resonant circuit 706. Therefore, in some embodiments, the natural frequency of the resonant circuit 706 of the charging device 50 may be determined by determining the frequency at which the driver 708 provides pulses to the resonant circuit 706.

[0078] The charging device 50 may include an energy storage device 710. The energy storage device 710 may be any device and / or feature configured to store energy, and may include, for example, one or more batteries, capacitors, fuel cells, etc. In some embodiments, the energy storage device 710 may be configured to provide charging energy to the charging module 704 for charging the IPG 10. In this embodiment, the energy storage device 710 is a rechargeable battery that is inductively recharged by a charging dock in which the charging device may be stored when not in use.

[0079] In some embodiments, for example, where the IPG 10 is implanted such that at least one of the axes 802, 809 is parallel and / or substantially parallel to the skin surface closest to the IPG 10 and / or intended to charge the IPG 10, the use of a planar winding 852 in the charging device 50 in combination with an elongated winding 800 in the IPG 10 may eliminate the need to control the rotational orientation of the charging device 50 relative to the IPG 10. This may simplify the positioning of the charging device 50 relative to the IPG 10. Specifically, when the IPG 10 and the charging device 50 have a relative orientation such that the axes 802, 809 of the charging circuit 15 of the IPG 10 are not parallel to the winding axis 854 and / or the core axis 864 and / or have a relative orientation such that the axes 802, 809 of the charging circuit 15 of the IPG 10 are perpendicular and / or substantially perpendicular to the winding axis 854 and / or the core axis 864, the effect of the relative rotational orientation of the charging device 50 relative to the IPG 10 is reduced. In such an embodiment, efficient energy transfer from charging device 50 to IPG 10 may be achieved by positioning charging device 50 proximate to IPG 10 without also having to control the rotational orientation of charging device 50 about charging device axis 55. Since the rotational orientation of charging device 50 does not need to be controlled, positioning of charging device 50 for recharging IPG 10 is simplified, and thus recharging of IPG 10 is simplified.

[0080] As part of or after the positioning of the charging device 50 relative to the IPG 10, the charging device 50 can power the transmitting coil assembly 850, and specifically, the charging module 704 can power the transmitting coil assembly 850. In some embodiments, such powering of the transmitting coil assembly 850 can include generating a series of pulses by the driver 708, the timing of which is set to cause resonance in the charging circuit 706. These pulses are then delivered to the charging circuit 706, thereby generating resonance in the charging circuit 706 at the resonant frequency of the charging circuit 706 and / or another desired frequency. Through such powering of the charging circuit 706 and the current oscillation at the charging circuit 706, a magnetic field can be generated by the transmitting coil assembly 850. The magnetic field can be directed away from the circuit 870 of the charging device 50 by the core 862 of the transmitting coil assembly 850. The magnetic field can be generated until the charging device 50 determines to terminate the charging of the IPG 10 and / or until the charging device 50 is instructed to terminate the charging of the IPG 10. Thus, the charging operation in which positioning of the charging device is performed may be a standard operation charging, or may be a modified charging operation specifically adapted for placement of the charging device, for example, as described above.

[0081] Figure 8A schematic diagram of a system 800 with an IPG 80, a charging device 802 (e.g., standard or dedicated), and an alignment indicator 803 is shown according to some embodiments. In this embodiment, the charging device 802 communicates directly with an implantable pulse generator 801 across the patient's skin to facilitate controlled transcutaneous energy transfer between the charging device and the implantable device. Typically, such transcutaneous communication is performed by shortwave radio transmission (e.g., MedRadio). The charging device 801 then transmits one or more charging parameters to the alignment indicator 803, which can be displayed on a user interface of one or more external computing devices or can be incorporated into the charging device itself. Typically, the latter communication is performed by another type of shortwave radio transmission (e.g., Bluetooth). In some embodiments, the alignment indicator utilizes information obtained only from the charging device, which includes charging parameters from both the charging device and the implantable pulse generator during charging. In some embodiments, the alignment indicator may also include information obtained directly from the implantable pulse generator or information obtained from both.

[0082] Fig. 9 A schematic diagram of a system 900 with a charging device 910 having a charging coil 911 and a charging module 912 having circuits and processors configured to control transcutaneous charging with an IPG is shown. The charging module 912 is also configured to transmit one or more charging parameters p(s) to an external user device 920 during charging upon receiving a request from the external device. The external device 902 indicates alignment as an alignment indicator 921 on a user interface. The indicator may include any of an audio, visual, or tactile output on a user interface of the external device 920. In some embodiments, the external user device 920 is associated with an expert (e.g., a field technician, a device provider representative), while in other embodiments, the user device may be associated with a clinician (e.g., a clinician programmer) or may be associated with a patient (e.g., a patient remote control, a smart phone, a tablet device). In this embodiment, the alignment indicator may be a display of charging parameters or associated metrics (e.g., charging signal strength, charging efficiency, current, voltage, etc.) obtained directly from the charging module. In some embodiments, these parameters or metrics may be parameters or metrics that have already been obtained and determined by the charging module during standard charging operations, such that no further processing of the parameters or metrics by an external device is required.

[0083] Fig.10A schematic diagram of a system 1000 is shown having a charging device 1010 having a charging coil 1011 and a charging module 1012 having circuits and a processor configured to control transcutaneous charging with an IPG. The charging module 1012 is also configured to transmit one or more charging parameters p(s) to an external device 1020 during charging. The external device 1020 indicates alignment as an alignment indicator 1022 on a user interface. The indicator may include any of an audio, visual, or tactile output on a user interface of the external device 1020. In some embodiments, the external user device 1020 is associated with a specialist, while in other embodiments, the device is associated with a clinician or a patient. In this embodiment, the external device also includes an alignment module 1021, which is configured to receive the charging parameters and process the parameters into a useful metric (such as charging efficiency), or determine a suitable alignment indicator based on the one or more charging parameters.

[0084] Fig.11 1 shows a schematic diagram of a charging device 1110 and an external device 1120, wherein the charging device 1110 has a charging module 1111, and the external device 1120 has an alignment indicator 1121, which is aligned with the charging module 1111. Fig.10 The alignment module 1112 operates in a substantially same or similar manner as in the embodiment of the present invention, except that the alignment module 1112 is included in the charger 1110. In some embodiments, this functionality is provided by a software push update from the external device to the charger.

[0085] Fig.12 A schematic diagram of a charging device with an integrated alignment indicator is shown. The charger 1210 includes a charging module 1212, an alignment module 1213, and an alignment indicator 1214, which operate in a manner similar to that in the previous embodiments, except that the output of the alignment indicator is provided by the charger itself. The indicator may include any of the following: an audio, visual, or tactile output on a user interface of the external device 920. In some embodiments, the indicator is an audio output, such as a series of beeps or tones, or an audio verbal instruction to the user. In this embodiment, it may be advantageous to use different types of indicator alerts or adaptive alerts based on charging parameters, for example, a series of beeps whose frequency increases as charging efficiency increases, and / or becomes a continuous beep when maximum charging efficiency is detected to indicate the optimal charging device position.

[0086] In another aspect, the charging device may include one or more position sensors 1215 (such as accelerometers), and the output from the position sensors may be used to determine the relative position or movement of the charging device during manual positioning of the charging device. The position sensor may be included in any embodiment described herein. The output from one or more sensors may be used to determine specific directional guidance to a user or clinician, for example, instructions to move the charging device up, left, or right to improve alignment. In some embodiments, the sensor may identify the rotational orientation of the charging device so that the user may receive instructions to rotate the charging device to further align the corresponding coil. It should be noted that adhesive attachment devices and straps allow the charging device to rotate while being supported therein, as described in U.S. Patent No. 10,682,521, which is incorporated herein by reference in its entirety. In some embodiments, the attachment device may also include one or more sensors so that the relative position and / or orientation of the charging device can be determined from the sensor position output.

[0087] In another aspect, the present invention relates to a dedicated application configured to operate on an external user device that communicates with a charging device and / or an implantable pulse generator. In some embodiments, the external user device can be any of an expert device, a clinician programmer, a patient remote control, or other dedicated medical devices associated with a neurostimulation system. In some embodiments, the external computing device can be a standard computing device associated with an expert, clinician, or patient, such as a smartphone, tablet device, laptop, or desktop computer, in which the functionality of performing the methods described herein is provided at least in part by the operation of a dedicated application embodied by executable instructions recorded on a memory of the corresponding user device.

[0088] Figure 13-18 An exemplary screen view of a user device within a dedicated application with an alignment indicator within the user device is shown in accordance with some embodiments. The dedicated application performs a charging device alignment process by which an expert or clinician can observe fine-tuning the alignment while the user manually adjusts the position of the charging device. This process can be used during initial setup of the system with a patient, as well as used as needed, or at any subsequent time to resolve charging issues, such as when a patient experiences suboptimal charging performance due to migration of an implanted charger or significant weight loss.

[0089] like Fig.13As shown, the external user device initiates the fine-tuning charging device alignment process by making a selection on a user interface display 1300 that is communicatively coupled to the charging device. The user device includes an antenna that wirelessly communicates with an antenna in the charging device. Typically, the devices communicate via short wavelength UHF radio waves such as Bluetooth. The charging device and the external user device establish secure communication through an authorization procedure or handshake, for example, by exchanging identification information between a clinician programmer to ensure that the charging device is communicating with an authorized device and that information from the charging device is secure.

[0090] like Fig.14 As shown, the alignment process outputs a screen display 1400 for fine-tuning the alignment, which includes an alignment indicator 1401 on the graphical user interface display of the user device to facilitate fine-tuning the alignment of the charging device during charging. While the charging device is performing a charging operation, the interface displays the alignment indicator in real time, and the alignment indicator is continuously updated while the user manually adjusts the charging device to allow the user to determine the optimal position of the charging device. In this embodiment, the indicator 1401 is a dynamically updated display of the charging efficiency. The charging efficiency can be determined from the corresponding charging parameters that the charging device has obtained during charging. For example, the charging efficiency can be determined by comparing the power output of the charging device with the charging power generated in the implanted medical device. By manually adjusting the charging device within a suitable position range for charging to occur while observing the charging efficiency, the alignment between the coil of the charging device and the implanted device can be fine-tuned to locate the optimal charging position. Once the optimal position is found, its position can be recorded by the user, by annotations made by the clinician in the clinician programmer, and / or by a photograph taken by the clinician programmer and stored on the user device and then transmitted to the clinician and the patient. The optimal position information may be stored by the user device and associated with the patient such that the patient or clinician may access the optimal position information at a later date such that the patient may continue to replicate the optimal position during subsequent charging sessions.

[0091] like Fig.15As shown, the external user device display 1500 with the alignment indicator 1501 can also display the maximum or peak charging efficiency detected during the alignment process, so that the clinician and the patient can easily identify when the optimal position is reached. This information can be transmitted by various other means, for example, by a dedicated charging metric unique to the neural stimulation system, a simplified rating system for rating the charging efficiency (levels 1 to 5), or by an audio alarm (e.g., instructions, beeps, tones), or any suitable means. In some embodiments, when the current charging efficiency is at the maximum or target charging efficiency detected, the indicator 1501 may include additional indications (e.g., alarms, beeps, tones). In some embodiments, the external user device is configured to determine (e.g., via a dedicated application) a target value and / or range for the alignment indicator. The value can be one or more charging parameters, a relationship between parameters (e.g., efficiency), or a quantitative measurement (e.g., ranking, size, etc.). In some embodiments, the target value and / or range is determined based on any of the history of the alignment indicator value, the history of one or more charging parameters, and the associated charging metric. In some embodiments, the history used to determine the target value and / or range comes from a given charging session. In other embodiments, the history is from multiple sessions (e.g., 2 or more sessions, a set number of recent sessions (e.g., 3, 4, 5), all charging sessions within a selected time period (e.g., weeks, months, years), or all previous charging sessions. In some embodiments, the target range is less than the total range of values ​​determined in the charging sessions. In some embodiments, a software application on the user device is configured to compile and / or analyze historical data of the alignment indicator from multiple charging sessions and output the history of the alignment indicator to the user as a graph or other visual, and / or determine trends in changes in alignment and charging parameters. This can be used to identify changes in the position of an implanted medical device over time or changes in device performance that require intervention by a clinician, provider, or device manufacturer. Fig.16 As shown, the external user device display 1600 with the alignment indicator may also include instructions or guidance 1601 to the user to further facilitate fine-tuning the alignment. For example, if the current charging efficiency indicates that the charging is suboptimal, the guidance may instruct the user to further adjust the charger position.

[0092] like Fig.17As shown, the external user device display 1700 with the alignment indicator may also include directional instructions or guidance 1701. The directional guidance may include specific instructions on how the charging device should be adjusted, for example, instructions to move the charging device up / down / left / right a recommended distance, or to move the charging device by rotating the charging device. The guidance may be informed by a position sensor (such as one or more accelerometers) disposed on the charging device, as described herein. The guidance may then indicate to the user when the optimal position is detected.

[0093] like Fig.18 As shown, the fine-tuning alignment process can be performed on a small user device (e.g., a smart phone) 1800 of a patient, expert, or clinician, and can include any features of the alignment process described herein. In this embodiment, the alignment indicator includes directional guidance 1801 that can be provided in conjunction with an audio alarm. For example, audio instructions for the user to move the charging device (e.g., slowly move the device left / right / up / down or at an estimated distance). In some embodiments, the alarm can change during the adjustment of the charging device so that the user can recognize when the optimal position is reached, for example, a beep that increases as the charging efficiency increases and changes to a continuous beep when the maximum efficiency is detected.

[0094] This method has the advantage of allowing the user to fine-tune the placement of the charging device in a home environment as needed. In some embodiments, the patient can perform fine-tuning charging by using a dedicated application on their own personal device. In other embodiments, the patient's device can communicate with both the charging device and the expert device or clinician programmer through a network, so that the expert or clinician can remotely facilitate fine-tuning adjustments through the patient's device. In some embodiments, when charging becomes inefficient, the fine-tuning alignment process can be at least partially initiated automatically. For example, if daily charging becomes increasingly inefficient, for example, when the patient loses weight, the patient's personal computing device (e.g., a smart phone, a tablet device) can initiate a suggestion or alert to the patient to perform fine-tuning alignment of the charging device, and guide the patient through the process on their personal computing device, or facilitate a process performed remotely by an expert, clinician, or health care provider using a user's personal computing device that communicates with the clinician's computing device through a remote server or network.

[0095] Figure 19-20 An exemplary method of charging an implanted device using a charging device and an alignment indicator is shown in accordance with some embodiments.

[0096] like Fig.19As shown, the method may include the following steps: initiating a fine-tuning charger alignment process on an external device 1901; establishing communication between the charging device and the external device 1902; performing a charging operation using the charger device 1903 and transmitting one or more charging parameters to the external device; determining the charging efficiency based on one (or more) charging parameters using the external device 1904; and outputting an alignment indicator based on the charging efficiency in real time using the external device during the position adjustment of the charging device 1905. The alignment indicator may include one or more features or combinations described herein (e.g., visual, audio, tactile).

[0097] like Fig. 20 As shown, such a method may include the following steps: positioning a charging device on a user near an implanted medical device (IMD) 2001; outputting a first indicator from the charging device or an external device, the first indicator indicating that the charging device is close enough for charging 2002; performing a charging operation; determining a charging efficiency based on one (or more) charging parameters using an external device or the charging device 2004; and outputting a second indicator from the charging device or the external device based on the charging efficiency, the second indicator indicating a fine-tuning coil alignment between the charging device and the IMD 2005. The alignment indicator may include one or more features or combinations (e.g., visual / audio / tactile) described herein.

[0098] In another aspect, the functionality of the charging device with respect to any alignment indicator feature herein may be affected by a software push through an external user device (e.g., an expert device, a clinician programmer, or a patient personal computing device (e.g., a smart phone)) that communicates with the charging device. In some embodiments, dedicated software configured for fine-tuning alignment may facilitate a software push through a clinician programmer or a patient personal computing device to the charging device. In some embodiments, the dedicated software application may be configured to upgrade the software on the implanted medical device (e.g., IPG) from the user device through the charging device when the charging device is positioned on the patient above the IPG (e.g., immediately before, during, or after charging). The upgrade may include features related to charging alignment and / or various other features unrelated to charging alignment. In another aspect, periodic communications between the user device and the charging device during a charging session may be used for various auxiliary functions, including: programming of stimulation profiles from the user device (e.g., performed by a clinician, or sent by a clinician to the patient's user device) and / or downloading data logs from the implanted device.

[0099] In one aspect, the charger alignment features described herein are incorporated into a dedicated software application (e.g., SmartCharge App) operable on a computing device of an expert, clinician, or patient to facilitate improved alignment of a corresponding charging coil of a charging device with an implanted medical device. In some embodiments, the alignment application is deployed on a device associated with an expert (e.g., a field technician, a device provider representative, or a clinician expert). In some embodiments, the application is provided on a patient device to help the patient improve alignment of the charging device with the implanted medical device. In some embodiments, a user connects an external user device (e.g., a smart phone / tablet device / laptop) to the charging device for local communication (e.g., via Bluetooth), and uses a dedicated software application to monitor charging data and efficiency between the charging device and the implanted medical device.

[0100] In some embodiments, the charger alignment tool is a dedicated application (e.g., a smart charging application) that is separate from the standard conventional charging application that the patient uses during conventional charging. In some embodiments, the dedicated alignment application is configured for use by experts only. Therefore, the dedicated charger alignment application can utilize a special login to ensure proper authorization and authentication of the corresponding device. A flowchart of the login protocol is provided in Fig.21 and an exemplary login screen is shown in Fig. 22 Shown in.

[0101] Fig.21 An exemplary login flow chart decision tree embodied in programmable instructions of a software application stored on a user device is shown. The flow chart includes: step (1) starting the application, and then step (2) displaying a login screen (e.g., see Fig. 22 ), before initiating a wireless connection (e.g., via Bluetooth) by pressing a "Connect" button, identification information (e.g., the serial number of the charging device) is entered via a login screen through a user interface of the user device. Next, the software application executes step (3) to evaluate whether wireless communication (e.g., Bluetooth) is active on the user device. If not active, step (4) notifies the user that wireless communication must be turned on and returns to step (2); if active, the program executes step (6) to wirelessly connect the user device to the charger device and displays an action indicator (e.g., "Connected to charger"). Next, the software application executes step (7) to evaluate whether the charger device is connected to the user device. If not connected, the software application displays an error message on the user device (e.g., "Unable to find charger. Please verify the serial number entered and check if the charger is turned on"). If connected, the software application executes step (9), which proceeds to the main display screen to perform charging alignment (see Figure 23-24 (screen in the upper right corner).

[0102] Fig. 22 A login screen 2200 of the charger alignment tool application on a user device is shown. The screen displays login instructions to the user to initiate charger alignment as described herein. These instructions to the user include: 1) ensuring that the user device includes activated wireless communication (e.g., Bluetooth), 2) ensuring that the charging device is "on", and 3) entering identification information (e.g., the serial number of the charger device). In some embodiments, this last step provides error prevention by obtaining a 10-digit serial number from the back of the charging device. This ensures a secure connection to the appropriate device. The login then provides a button through which the user can wirelessly connect the user device to the charging device. In some embodiments, the login screen is compatible with a conventional touch screen interface of a dedicated smart phone or tablet device, and in other embodiments, the software application can be used on a standard personal device (e.g., a smart phone / tablet device).

[0103] Fig.23 An exemplary home screen 2300 of a dedicated alignment application (e.g., "Smart Charging") for facilitating fine-tuning charging alignment is shown. The home screen displays various indicators related to the status of the battery, connection, and charging to allow fine-tuning alignment of the charging coil based on one or more charging parameters obtained from the charging device. On the main display, a back button (e.g., a left arrow) in the upper left corner takes the user back to the home screen. Fig. 22, which disconnects the charger device from the user device until the "Connect" button is pressed again. Below the back button is a battery / charging status indicator 2301, which displays the status as "Charging" and the battery capacity as 62%. At the top of the main screen is a connection indicator 2305, which shows a green circle indicating that the user device and the implanted neural stimulation system (INS) are communicatively coupled. If the INS loses connection with the user device, the main screen will display the status indicator 2031' (see the details of the display "Searching for INS..." in the upper left), and the connection indicator 2035' will be displayed as a gray bar indicating no connection. The main screen also includes a charging time indicator 2302 that indicates the time parameter of the charging. This indicator can be included in a collapsible menu titled "Estimated Time". Typically, the estimated remaining time is refreshed periodically (e.g., every 30 seconds, every minute). The main screen also includes a historical charging efficiency indicator 2303 shown on the right, which shows a history or log of charging efficiency over a period of time during the charging period. The charging efficiency history is typically shown as a graph, but may also be shown as a series of bars. The main screen also includes a current charging efficiency level indicator 2304 shown at the bottom, which shows the current real-time charging efficiency, and may also show the standard charging range and peak. Once the INS is fully charged, the top left top will display "Fully Charged" and a pop-up notification will present the status: "This INS is fully charged. Session ended. Please wait for the charge to drop to 90% in order to use smart charging for this INS.".

[0104] In one aspect, the historical charging efficiency indicator 2303 may indicate changes in charging efficiency over an elapsed time period during charging. Fig.23 In the embodiment of FIG. 1 , the time period is a 60 second time period. The graph is continuously updated to reflect the most recently elapsed time period, allowing the user to observe changes during charging as the charging device is actively moved. In this embodiment, the graph is a bar animated to the right, with the rightmost value being the most recent charge level. The peak efficiency can be marked on the graph with a straight horizontal line across the graph, which shows the highest efficiency achieved for the charging session.

[0105] Fig.24 An alternative home screen 2400 of a dedicated charging alignment software application is shown. Fig.23 , the main screen shows a connection status indicator 2405, a charging / battery status indicator 2401, a charging time indicator 2402 (showing a drop-down menu title), a charging efficiency history indicator 2403, and a current real-time charging efficiency level indicator 2404 with a standard range and peak level indicator, as shown. Figure 25-27 Detailed views of a selection indicator are shown, along with additional charge level indicators based on charge percentage and rotational alignment.

[0106] Fig.25 A charging time indicator 2502 is shown indicating time parameters for an estimated remaining time and an estimated total recharge time. In this embodiment, the indicator is shown within a collapsible menu. In some embodiments, the estimated remaining time is determined based on an average steady-state charge rate and an initial battery capacity at the start of a charging session. In some embodiments, the initial battery capacity is determined based on a voltage measurement of the battery obtained by the user device from a charging device. The software application determines the total estimated time to perform a full charge and the estimated remaining charge time, which is continuously updated.

[0107] Fig.26 A charging efficiency indicator 2601 is shown. In this embodiment, each level is indicated in contrasting colors (e.g., green versus gray) according to percentage. Typically, the target efficiency is levels 3-5 (shown in green) to contrast with lower suboptimal efficiency levels 1 and 2 (shown in gray). Fig.17 A rotational charging efficiency indicator 2701 is shown showing the charging efficiency level associated with each rotational alignment. Typically, this indicator is observed when the charging device is held in one position and rotated by the user to promote an optimal rotational alignment condition between the INS and the charging device. In this embodiment, the rotational alignment can be in a reference position (e.g., an initial position) and determined relative to a reference (e.g., a rotation angle in a clockwise direction).

[0108] Fig.28 A detailed view of a current charging efficiency level indicator 2800 is shown, showing the current charging efficiency level as a bar, such as an animated bar representing the charging efficiency determined in real time. The bar can extend between different charging efficiency levels 1 to 6. A standard range 2802 of typical charging efficiencies can indicate expected efficiency and guide the clinician and / or patient during positioning. The bar graph can also include a peak level indicator 2803 (e.g., a vertical bar) that indicates the highest charging level determined during the charging session.

[0109] In another aspect, the charging alignment tool and associated software application can be specifically configured for use by an expert (e.g., a field technician, a representative of a device provider, a clinician expert). For example, the software application described herein can be provided with expert-only login access for use on an expert's user device for patient training purposes and / or to resolve charging alignment issues experienced by certain patients. In some embodiments, the dedicated alignment application is configured for use with a dedicated charging device with advanced charging capabilities to simplify the charging alignment process.

[0110] In some embodiments, the alignment application provides real-time feedback to an expert (e.g., field technician, sales field team member, device provider representative, clinical expert) regarding the quality of alignment between the charger device and the INS in order to optimize patient charging through high-quality patient education and training, or to allow advanced problem solving, including when the INS is in sleep mode or hibernation. This approach of including the alignment tool feature only on expert devices improves the patient experience while minimizing the occurrence of unnecessary device revisions and updates on standard devices and applications used by clinicians and patients.

[0111] In one aspect, the charging alignment setting may utilize a specialized charging device having additional functionality compared to a standard charging device. Fig.29 A system is shown utilizing an expert device 300 having a display 310 and a dedicated charging device 95 (e.g., a "green charger") that is operable to communicate charging parameters to the device 300 so that an alignment indicator is displayed on the display 310. In such an embodiment, the dedicated charger may include additional communication functionality (e.g., Bluetooth enabled) to communicate with a user device (e.g., the expert's user device), a feature that is not required for most patients' standard charging devices. Similarly, the software application may be configured to be operable only on a user device accessed by the expert. In some embodiments, the software application is configured to display at least battery status information and a charging efficiency indicator of the charging connection between the charger and the INS. As described above, the display may also include a charging time parameter or a charging efficiency history.

[0112] Fig.30 The dedicated charging device 95 is shown connected to a dedicated software application on the expert user device 310. Fig. 22 , the user display 310 shows an initial login screen to facilitate the initial connection with the dedicated charging device. In some embodiments, if the INS battery is depleted and in sleep mode, some charging will be required before the dedicated application can communicate with the INS.

[0113] After connection, the charging device can be used in the usual manner to initiate wireless recharging of the INS. The dedicated application communicates with the dedicated charging device via local communication (e.g., Bluetooth) to obtain one or more charging parameters to determine and display the charging efficiency level, which can be used to determine a more efficient charging position of the charging device on the patient. More efficient charging means faster charging with fewer disconnections. Charging efficiency depends on: INS depth, charger alignment, and charger rotation.

[0114] During charging, the alignment application displays the home screen on the display 310 of the expert device 300 (see Figure 23-24 ) which shows various indicators related to charging. Fig.31 In the illustrated embodiment, the application is configured to display a battery / charging status indicator 301, a current efficiency level indicator 304, and a connection status 305. The battery / charging status indicator 301 may show a battery / charging status 301a (e.g., 87%) and a charging status (e.g., “charging”), an INS serial number 301b, and a charging device serial number 301c. Fig.32 As shown, the current efficiency level indicator 304 (such as Figure 23-24 The system may be configured with a level 5 corresponding to accelerated charging. The dedicated charging device may be specifically configured with an accelerated charging mode that can charge faster than the standard mode of the standard charging device used by the patient. Level 5 accelerated charging may not be achievable or necessary for all patients. This mode may allow even further enhanced visibility of the optimal alignment position. In some embodiments, the accelerated charging feature enables the charging device to charge faster and wake up a dormant INS. In some embodiments, after the INS is fully charged to establish a connection, the dedicated charger charges at the same rate as the standard charge used by the patient.

[0115] When the charging status / efficiency indicator is shown to the expert on the home screen of the user's device, the user moves the charging device, such as Fig.33 and 34 The following instructions may be provided via the dedicated application, or through instruction materials provided with the dedicated application and / or dedicated charger. Fig.33 The user is shown slowly moving the charger up, down, inwards or outwards to ensure alignment of the charger, optionally on the INS. Fig.34 The user is shown rotating the charging device 95 counterclockwise (on the left) or clockwise (on the right). In some embodiments, the user can roughly determine the angle by observing the position of a feature of the charging device (e.g., a logo, marking, flat top). The target orientation can be rotated relative to a reference (e.g., a vertical or horizontal axis, or an incision of an INS implant). When holding the charging device to achieve a specific rotational orientation, the patient can manually feel the flat top portion, or the patient can position the charging device in the desired rotational orientation within the strap prior to attachment. Preferably, the strap is configured to allow the patient to rotate the charging device while being secured within the opening of the strap.

[0116] In an exemplary alignment process, a user moves the charging device during charging (e.g., Fig.33 The user then rotates the charging device and observes any changes in the charging efficiency to determine the optimal rotational orientation to provide the optimal charging efficiency. This rotational orientation is also recorded. In some embodiments, palpating the INS can provide a better understanding of the required charging device alignment prior to the process, which can then be verified using a dedicated application.

[0117] Once the expert determines the optimal charging position, the expert is advised to 1) ensure that the position is repeatable in an attachment device (e.g., an adhesive device or strap), 2) take pictures or detailed notes or drawings of the ideal position, and 3) have the patient practice the ideal placement. In one aspect, the software-assisted process can be used during initial post-operative charging training so that the patient can be discharged with an optimal charger placement and charging experience. On the other hand, the process can also be used for problem solving for patients who experience suboptimal charging. In some patients, charging is still performed at levels 1 and 2 where the process indicates that optimal charging may be difficult to achieve. For such patients who cannot achieve level 3 or higher charging, the expert can recommend more frequent charging or using lower treatment settings when possible to extend battery life.

[0118] Fig.35An exemplary method of expert assessment of alignment is shown, which can be used for initial training and / or problem solving of charging alignment. The method includes the following steps: establishing communication between a user device and an external charging device, wherein the charging device is configured for transcutaneous charging of an implanted medical device, and the user device is an external computing device associated with an expert and has a dedicated application thereon for assessing charging alignment 3501; charging the implantable medical device using the external charger when at least a first-order alignment is achieved 3502; receiving one or more charging parameters or associated charging metrics from the charging device using the user device during transcutaneous charging of the implanted medical device 3503; displaying a real-time charging efficiency indicator on a display of the user device using the dedicated application based on the one or more charging parameters or metrics, wherein the charging efficiency indicator corresponds to fine-tuning the alignment between the external charging device and the implanted medical device 3504; and moving the external charger device on the patient while the expert observes changes in the charging efficiency indicator to determine an optimal position of the external charging device for charging 3505. In some embodiments, the dedicated application can be configured to be used only by the expert. In some embodiments, the charging device may be a dedicated device configured for use with the alignment application of the specialist device and may also include additional charging functionality to simplify the alignment optimization process.

[0119] In the foregoing description, the present invention is described with reference to specific embodiments of the present invention, but those skilled in the art will appreciate that the present invention is not limited thereto. As used herein, "user equipment" may refer to the equipment of any one of a patient, a clinician, or an expert associated with an equipment provider or a manufacturer. The various features and aspects of the above invention may be used individually or in combination. In addition, without departing from the broader spirit and scope of protection of this specification, this patent may be used in any number of environments and applications outside of those described herein. Therefore, the description and the accompanying drawings are considered to be illustrative rather than restrictive. As used herein, the terms "including", "comprising" and "having" are particularly intended to be understood as open technical terms.

Claims

1. A system for facilitating alignment between an external charging device and an implantable medical device in a patient, the system comprising: an external charging device having a charging coil disposed within a housing and configured to magnetically couple with a corresponding receiving coil of the implantable medical device, wherein the external charging device comprises: an antenna configured to communicate with one or more external devices, and a processor configured to control charging using the charging coil and to monitor one or more charging parameters during charging, wherein the external charging device comprises one or more indicators configured to indicate a first-order alignment of the external charging device with the implantable medical device and to enable charging when the first-order alignment is detected; and A portable user device having a housing, an antenna for communicating with at least one of the external charging device and the implantable medical device, a user interface, and a processor operably coupled to the antenna, the user interface, and a memory, the memory having a software application stored thereon, the software application configured for at least one of training and problem solving for charging, wherein the software application includes executable instructions configured to: Establishing communication with the external charging device; receiving communication of the one or more charging parameters or associated charging metrics during charging; and A charging efficiency indicator corresponding to the fine-tuning alignment between the external charging device and the implantable medical device is displayed in real-time, wherein the charging efficiency indicator is based on the one or more charging parameters or the associated charging metric.

2. The system according to claim 1, wherein: The portable user device is configured for use by a specialist who is at least one of a field technician, a representative, and a clinical care specialist associated with a provider of the implantable medical device.

3. The system according to claim 1, wherein: The software application includes a security login to ensure a secure connection between the portable user device and the external charging device.

4. The system according to claim 1, wherein: The portable user device is a tablet device.

5. The system according to claim 1, wherein: The external charging device is configured to communicate with the implantable medical device via a first type of communication and to communicate with the portable user device via a second type of communication.

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

7. The system according to claim 1, wherein: The external charging device is a dedicated charging device configured for use with the software application.

8. The system according to claim 7, wherein: The external charging device is configured for use by experts only.

9. The system according to claim 7, wherein: The external charging device includes an accelerated charging mode that operates at increased charging parameters compared to a standard charging mode of the patient's standard charging device.

10. The system according to claim 9, wherein: The external charging device is configured to charge the implantable medical device in the accelerated charging mode when the implantable medical device is in a sleep and / or low battery state, at least until communication can be established.

11. The system according to claim 10, wherein: The external charging device is further configured to charge the implantable medical device at the same rate as the standard charging mode after communication is established.

12. The system of claim 1, wherein: The software application is configured to display the charging efficiency indicator on a primary display screen, the primary display screen further displaying one or more additional indicators.

13. The system according to claim 12, wherein: The charging efficiency indicator is a bar extending between a plurality of different charging efficiency levels, wherein the bar is dynamically updated to show the current charging efficiency level in real time.

14. The system according to claim 13, wherein: The charging efficiency indicator further shows the peak level during the charging session.

15. The system of claim 14, wherein: The one or more additional indicators include a charging efficiency history indicator.

16. The system of claim 14, wherein: The one or more additional indicators further include a battery charge status.

17. The system of claim 14, wherein: The one or more additional indicators further include a connection status.

18. The system of claim 14, wherein: The one or more additional indicators further include a charging time indicator.

19. The system of claim 18, wherein: The charging time indicator includes one or both of an estimated charging remaining time and a total estimated charging time.

20. A method for positioning an external charging device relative to an implantable medical device, the method comprising: establishing communication between a processing device and an external charging device, wherein the charging device is configured for transcutaneous charging of an implanted medical device and the processing device has a software application thereon for evaluating charging alignment; When at least a first-order alignment is achieved, charging the implantable medical device using the external charging device; receiving, with the processing device, one or more charging parameters or associated charging metrics from the external charging device during transcutaneous charging of the implanted medical device; displaying, on a display of a user device having the software application, a real-time charging efficiency indicator based on the one or more charging parameters or metrics, wherein the charging efficiency indicator corresponds to a fine-tuned alignment between the external charging device and the implanted medical device; and The external charging device is moved on the patient in response to changes in the charging efficiency indicator shown on the display to determine an optimal position of the external charging device for charging.

21. The method according to claim 20, wherein: The step of moving the external charging device is performed by a field technician, representative, or clinical care specialist associated with the implantable medical device provider.

22. The method according to claim 20, wherein: The software application is configured for use only by authorized users.

23. The method according to claim 20, wherein: The external charging device is configured to communicate with the implantable medical device via a first type of communication and to communicate with the processing device via a second type of communication.

24. The method according to claim 23, wherein: The first type of communication is MedRadio and the second type of communication is Bluetooth.

25. The method according to claim 22, wherein: The external charging device is a charging device configured for use only with the software application.

26. The method according to claim 25, further comprising: When the implantable medical device is in a sleep and / or low battery mode, the external charging device is configured to charge the implantable medical device while operating in an accelerated charging mode compared to a standard charging mode.

27. The method according to claim 26, wherein: The external charging device is configured to charge the implantable medical device in the accelerated charging mode when the implantable medical device is in a sleep and / or low battery state, at least until communication can be established.

28. The method according to claim 27, wherein: The external charging device is further configured to charge the implantable medical device at the same rate as the standard charging mode after communication is established.

29. The method of claim 20, further comprising: The charging efficiency indicator is displayed as a bar that extends between a plurality of different charging efficiency levels and is dynamically updated to show the current charging efficiency level in real time.

30. The method of claim 29, further comprising: A peak level of charging efficiency during a charging session is displayed on the charging efficiency indicator.

31. The method of claim 30, further displaying one or more additional indicators on the display of the user device, wherein: The one or more additional indicators include any of the following: Charging efficiency history indicator; Battery charge status; Connection status; Charging time indicator; Estimated remaining charging time; Total estimated charging time; and Any combination thereof.

32. A system for wireless charging of an implantable medical device, the system comprising: An implantable medical device having a housing, the implantable medical device being configured to be implanted in a patient, the implantable medical device comprising an energy storage device disposed within the housing of the implantable medical device and a receiving coil disposed within the housing and electrically coupled to the energy storage device; an external charging device having a housing, the external charging device comprising a charging coil disposed within the housing of the external charging device, the charging coil being configured to magnetically couple with the receiving coil of the implantable medical device, and the receiving coil being configured to inductively receive energy from the charging coil and to provide at least a portion of the energy from the receiving coil to the energy storage device; as well as A portable user device configured to communicate with at least one of the external charging device and the implantable medical device, the portable user device comprising a user interface and a processor, the processor configured to run a software application configured to facilitate optimal positioning of the external charging device relative to the implantable medical device based on a real-time visual indicator of charging efficiency provided on the user interface.

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