System and method for aligning a charging device for an implantable medical device

Abstract

Disclosed herein are devices, systems, and methods for improving the alignment of a charging device and an implanted medical device. The system can include an external charging device that communicates one or more charging parameters during charging to a user device having an alignment function embodied in a software application that displays a real-time charging efficiency indicator based on the charging parameters. This alignment function can be used to determine an optimal position by observing the charging efficiency while moving the charging device during charging. The application and device are configured for use by professionals, such as field technicians or representatives of device providers, and can assist patients. The system can be configured for use with the application and can further include a charging device having additional charging functions. The alignment function may be included for training and / or troubleshooting alignment problems experienced by a particular patient.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 63 / 340,827, filed May 11, 2022, entitled "Implanted Medical Device Charger Alignment Tools and Methods for Use, Training, and Trouble Shooting", which is hereby incorporated by reference in its entirety for all purposes.

[0002] This application is also generally related to U.S. Non-Provisional Application No. 17 / 522,644, filed 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 is hereby incorporated by reference in its entirety for all purposes.

[0003] This application relates to implantable nerve stimulation therapy systems and related charging devices and methods.

Background Art

[0004] The use of medical devices in the treatment of diseases has been increasing over time. In many cases, and as these medical devices are miniaturized, these medical devices are frequently implanted within a patient. To power such devices, external charging devices that transcutaneously transfer energy to the implanted devices are used to power the implanted devices or to recharge the rechargeable batteries of the implanted devices. Such external charging devices typically utilize a charging coil that inductively couples with an internal coil of the implantable medical device. For efficient transcutaneous transfer of energy, it is necessary that the coils be properly aligned. Misalignment can result in recharge failure, inefficient recharge, and / or excessive heating. Some conventional systems include a function to indicate alignment (alignment), but these functions typically only indicate when alignment is suitable for charging to occur within an acceptable range and do not typically facilitate precise placement for optimal charging. This can lead to suboptimal alignment that results in extended recharge times and / or excessive heating. Further, current approaches to indicating alignment typically lack detailed guidance to facilitate the patient or clinician during precise alignment.

[0005] Accordingly, there is a need for devices, systems, and methods that facilitate improved precise alignment between an external charging device and an implanted medical device. Further, there is a need for an approach that provides guidance for improving alignment in an intuitive, interactive way that takes advantage of the features of existing systems. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0006] In one aspect, the subject matter relates to charging an implantable pulse generator by an external charging device, and more particularly 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 such that the device determines an alignment indicator based on a charging efficiency determined from one or more charging parameters. The alignment indicator may be an output of real-time charging efficiency during charging. The system outputs an indicator corresponding to alignment during charging. Typically, the indicator indicates alignment without modifying the charging operation based on the alignment determination. This indicator facilitates precise adjustment of alignment by the patient or clinician during the charging operation. In one aspect, the alignment function described herein can be incorporated into a user device of an expert (e.g., a field technician associated with the device manufacturer, an expert in clinical care) to enable the expert to assist in positioning the physician and / or patient's device. Such a function is particularly advantageous for training after the initial implantation and for troubleshooting alignment problems experienced by some patients. In some embodiments, the alignment function is embodied by a software application that is only accessible / usable by an expert and not by a patient, treating physician, or clinician device. In some embodiments, the alignment tool includes a user device having a dedicated software application thereon and configured to be used with a standard charging device or a dedicated charging device having additional features. These aspects are applicable to any of the embodiments described herein.

[0008] In some embodiments, the system includes a first indicator indicating a primary alignment (coarse alignment) corresponding to when the alignment between the coils is sufficient to inductively transfer energy for transcutaneous charging, and a second indicator indicating a secondary alignment (fine alignment) within a range of appropriate alignment positions to facilitate fine adjustment of the alignment to increase charging efficiency and shorten the charging time. In some embodiments, the system can include a third indicator indicating when the optimal alignment position has been reached. The first, second, and third indicators are distinguishable from each other such 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 primary or secondary. In some embodiments, the charging device includes a specific indicator for indicating a primary alignment (i.e., a rough alignment) so that the user can determine whether the initial placement is suitable for establishing inductive coupling and starting charging. Other specific alignment indicators are used to indicate a precise alignment or a secondary alignment (e.g., a fine-tuned alignment during charging to improve or optimize charging). Generally, when the primary alignment is lost, the inductive coupling is lost and charging stops completely, while when the precise alignment or secondary alignment is lost, the charging efficiency / optimization during charging decreases. In some embodiments, a specific other alignment indicator is an indicator provided by a charging device that is easily distinguishable from the primary indicator. In some embodiments, some other alignment indicators are provided by an external user device of the patient or clinician (e.g., a smartphone, a tablet). A specific other alignment indicator may be determined and output by a dedicated software application on a standard user device specialized for improving the alignment of the charging device. In some embodiments, a specific other indicator for secondary alignment is provided only by the user device. In some embodiments, the charging device includes a primary alignment indicator, while the user device includes indicators for both primary and secondary alignments.

[0010] In some embodiments, the alignment indicator is determined during a standard charging operation and output in real-time to the user (e.g., an expert, patient, and / or clinician) during charging so that the user can dynamically adjust the alignment of the charging device based on the indicator. In some embodiments, the alignment indicator is a charging efficiency indicator based on which the user can confirm an optimal alignment. The indicator may be incorporated into the charging device or provided by a user interface of one or more external devices. The indicator can include, but is not limited to, any one or any combination of visual, auditory, 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 the clinician's and patient's 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 enables additional functionality regarding precise placement to complement existing charging devices that already have a minimal alignment function.

[0011] In some embodiments, the external charging device includes a power button and one or more visual indicators, such as one or more light indicators (e.g., blinking, on, off) and one or more audio indicators (e.g., one or more tones / beeps), but is not limited thereto. The light indicators are used to indicate, but are not limited to, any of the power state (e.g., green light), the battery state of the external device (e.g., orange, blinking orange), the error state (e.g., red), and the charging state (e.g., blinking green). In some embodiments, the charging device charges the implanted medical device in a closed-loop charging state during standard charging and, when the battery of the implanted medical device is too low to perform closed-loop charging, charges the implantable medical device in an open-loop charging state and can 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 different charging states. The audio indicator can be used to indicate any of the initial alignment suitability for starting charging (e.g., long tone), the completion of charging (e.g., three rising tones), and the error state. In some embodiments, the external charging device includes a tactile indicator for indicating a change in the charging state that requires user intervention (e.g., primary misalignment, loss of charging coupling). This is particularly advantageous when the implanted medical device is implanted in the lumbar / upper buttock region where the patient cannot see the visual indicators of the charging device. This implantation site is common in sacral nerve modulation systems for the treatment of urinary incontinence and / or fecal incontinence. The use of the tactile function for alignment / loss of charging facilitates the patient's immediate response to correct / re-align the charging device to restore charging. Notably, conventional devices generally rely on the variety of audio and visual indicators (e.g., various patterns of beeps and blinking lights), which can make it easier for the patient to ignore or become confused and thus cause undue delays in restoring charging.If the next alignment is inappropriate, charging will stop completely, and the implanted medical device may not be able to charge within the time available to the patient or may significantly prolong the charging session. Therefore, this event is advantageously indicated by a unique indicator (e.g., a tactile vibration) that can be readily recognized by the patient and easily distinguished from the various beep sounds / flashing lights commonly used for other charging events (e.g., start, charging status, battery, completion, etc.). In some embodiments, the charging device includes a tactile indicator only for loss of charging due to misalignment of the primary alignment.

[0012] Further areas of applicability of the present disclosure will become apparent from the detailed description provided below. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not necessarily intended to limit the scope of the present disclosure.

Brief Description of the Drawings

[0013]

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[0014] The present subject matter relates to charging of implanted medical devices, particularly nerve stimulation therapy systems and related devices. In some embodiments, the subject matter relates to charging of an implanted nerve stimulation device of a sacral nerve stimulation therapy system configured to treat overactive bladder (“OAB”) and relieve symptoms of bladder related dysfunction. However, the present subject matter is also understood to be utilized for any of a variety of nerve modulation applications, such as treatment of bowel dysfunction, pain, or other indications such as movement or mood disorders, as well as other various implanted medical devices, as would be understood by one of ordinary skill in the art.

[0015] In some embodiments, the subject matter relates to a device that obtains one or more charging parameters from a charging device and / or an implanted nerve stimulation device and outputs an alignment indicator indicative of precise alignment between the charging device and the implanted device based on the one or more charging parameters. Currently, many implanted nerve stimulation systems include a receiving coil that receives energy transcutaneously from a charging coil within an external charging device placed on the patient's skin over the charging device. 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. Accurate alignment between the charging coil and the receiving alignment, including alignment along the x and y axes along the patient's skin, as well as the direction of rotation, greatly affects the efficiency of charging. Typically, conventional systems provide charging as long as the charging device is within an appropriate range of positions, but many positions within this range may provide sub-optimal charging with reduced charging efficiency that can lead to patient discomfort and poor charging, as described above. Accordingly, various embodiments enable precise placement of the charging device to fine-tune the alignment between the coil of the charging device and the implanted nerve stimulation device. Although a particular type of nerve stimulation system is described herein, it is understood that the concepts described herein are applicable to any type of nerve stimulation system and, further, to any charging device for an implanted medical device that benefits from optimal alignment and placement to the patient.

[0016] I. Indications for Nerve Stimulation A nerve stimulation (or neuromodulation, which may be used interchangeably hereinafter) treatment system as described herein can be used for the treatment of various diseases and related symptoms such as acute pain disorders, movement disorders, emotional disorders, and bladder-related functional disorders. Examples of pain disorders treated by nerve stimulation include failed back surgery syndrome, reflex sympathetic dystrophy or complex regional pain syndrome, causalgia, arachnoiditis, and peripheral neuropathy. Movement disorders include paralysis, tremors, dystonia, Parkinson's disease, etc. Emotional disorders include depression, obsessive-compulsive disorder, cluster headache, Tourette syndrome, certain types of chronic pain, etc. Bladder-related functional disorders include, but are not limited to, OAB, urge incontinence, urge frequency, urinary retention, etc. OAB includes urge incontinence and urge frequency, either alone or in combination. Urge incontinence is an involuntary loss of urine accompanied by a sudden strong urge to urinate (urgency). Urge frequency is frequent and often uncontrollable urinary urgency, resulting in very small amounts of urination (frequency). Urinary retention means the inability to empty the bladder. Nerve stimulation treatment can be configured to address a particular condition by applying nerve stimulation to the target nerve tissue related to the sensation and / or motor control related to that condition or related symptoms.

[0017] In one aspect, the methods and systems described herein are particularly suitable for the treatment of urinary and fecal incontinence. These conditions have not been historically well recognized and are significantly undertreated by the medical community. OAB is one of the most common urinary functional disorders. It is a complex disease characterized by the presence of bothersome urinary symptoms such as urgency, frequency, nocturia, urge incontinence, etc. It is estimated that about 33 million Americans suffer from OAB. Among the adult population, approximately 30% of men and 40% of women live with OAB symptoms.

[0018] The symptoms of OAB can have a significant negative impact on the psychosocial function and quality of life of patients. OAB patients often restrict their activities and develop coping strategies. In addition, OAB imposes a significant economic burden on the patient, their family, and the healthcare system. The prevalence of comorbidities is also significantly higher in OAB patients compared to the general population. Comorbidities include falls, fractures, urinary tract infections, skin infections, vulvovaginitis, cardiovascular diseases, and central nervous system diseases. Chronic constipation, fecal incontinence, and overlapping chronic constipation occur more frequently in OAB patients.

[0019] Conventional treatments for OAB generally include lifestyle modifications as the first step. Lifestyle modifications include removing bladder irritants (such as caffeine) from the diet, managing fluid intake, losing weight, quitting smoking, and managing bowel regularity. Behavioral modifications include improving urination habits (such as bladder training and delayed voiding), pelvic floor muscle training to improve the strength and control of the urethral sphincter, biofeedback, and techniques to suppress urgency. Pharmacological therapy is considered the second-line treatment for OAB. This includes anticholinergic drugs (oral, transdermal patch, gel) and oral β3-adrenergic agonists. However, anticholinergic drugs are often associated with bothersome systemic side effects such as dry mouth, constipation, urinary retention, blurred vision, drowsiness, and confusion. According to research, more than 50% of patients discontinue the use of anticholinergic drugs within 90 days due to reasons such as lack of effectiveness, adverse events, and cost.

[0020] II. Sacral Nerve Modulation Sacral neuromodulation (SNM) is an established treatment that provides a safe, effective, reversible, and long-term treatment option for the management of urge urinary incontinence, urge frequency, and non-obstructive urinary retention. In SNM therapy, the sacral nerves in the lower back are stimulated with mild electrical pulses. Electrodes are placed beside the sacral nerves (usually at the S3 level) by inserting electrode leads into the corresponding foramina of the sacrum. The electrodes are inserted subcutaneously and then attached to an implantable pulse generator (IPG), also referred to herein as an "implantable nerve stimulation device" or "nerve stimulation device". The safety and efficacy of SNM in the treatment of OAB have been supported by multiple studies, including five-year durability for both patients with urge urinary incontinence and urge frequency, and are well-established. SNM is also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

[0021] A. Implantation of the Sacral Neuromodulation System Currently, SNM approval involves a trial phase with an external nerve stimulation device, and if successful, permanent implantation with a fully implantable rechargeable nerve stimulation device. The trial phase is a test stimulation period for the patient to evaluate whether the treatment is effective. Usually, there are two methods for test stimulation. One is a clinic-based procedure called percutaneous nerve evaluation (PNE), and the other is a staged trial.

[0022] The mechanism of action of SNM is multifactorial and affects the neural axis at several different levels. In patients with OAB, it is thought that by suppressing the afferent limb of the abnormal micturition reflex, the clitoral afferent nerves activate an inhibitory reflex that promotes bladder storage. This blocks the input to the pontine micturition center and suppresses involuntary striated muscle contractions without interfering with the normal micturition pattern. In patients with urinary retention, SNM is thought to activate the clitoral nerve afferents that project from the pelvic viscera to the spinal cord. At the spinal cord level, it is thought that the clitoral afferent nerves turn on the micturition reflex by suppressing the exaggerated alerting reflex, alleviating the symptoms of patients with urinary retention and promoting normal micturition. In patients with fecal incontinence, a hypothesis is proposed that SNM stimulates the penile afferent somatic fibers to suppress the propulsive activity of the large intestine and activates the internal anal sphincter, thereby improving the symptoms of patients with fecal incontinence. The present subject matter relates to a system adapted to deliver nerve stimulation to target nerve tissue in a manner that disrupts, suppresses, or prevents nerve activity in the target nerve tissue so as to provide a therapeutic effect in the treatment of OAB or bladder-related dysfunction. In one aspect, the system is adapted to provide a therapeutic effect by nerve stimulation without inducing motor control of the muscles associated with OAB or bladder-related dysfunction by the delivered nerve stimulation. In another aspect, the system is adapted to provide such a therapeutic effect by delivering nerve stimulation below the threshold for inducing sensory abnormalities and / or neuromuscular responses or by enabling adjustment of the nerve stimulation for delivering treatment at sub-threshold levels.

[0023] In the use of sacral nerve modulation, it is common to implant an implantable nerve stimulation device in the patient's lower back / upper buttocks to better access the sacral nerves through the sacrum (see Figure 3). Such an arrangement of the external charging device can be difficult for the patient to observe, thereby frustrating the accurate placement over time, especially due to movement and weight fluctuations. Current nerve stimulation systems provide a significant improvement in the efficiency of stimulation, but such systems typically require periodic charging by using an external charging device placed on top of the patient over the device. Usually, the patient charges the nerve stimulation device periodically, such as every few days, weekly or monthly, depending on the frequency of use and the stimulation level of the treatment. If the charging device is optimally placed, many implantable nerve stimulation devices can be recharged within 2 hours, often within 1 hour, while minimizing patient discomfort. However, if not placed accurately, charging can take significantly longer, for example, exceeding 1 hour, such as more than 3 hours. Furthermore, a suboptimal placement can result in excessive heat accumulation, and prolonged contact with the external charging device can cause considerable nuisance and patient discomfort. Therefore, as further described below, it is desirable to provide an apparatus and method that facilitate accurate and consistent placement of the charging device.

[0024] B. Example Embodiments Figure 1 schematically shows an exemplary nerve stimulation system that includes both a trial nerve stimulation system 200 and a permanent implanted nerve stimulation system (INS) 100. The EPG 80 and the IPG 10 are each compatible with and wirelessly communicate with a clinician programmer 60 and a patient remote device 70, which are used for positioning and / or programming the trial nerve stimulation system 200 and / or 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 with lead placement, programming, reprogramming, stimulation control, and / or parameter setting. Further, each of the IPG and the EPG enables at least some control by the patient over the stimulation (e.g., initiation of a pre-set program, increase or decrease of stimulation), and / or monitoring of the battery state by the patient remote device. This approach also enables a nearly seamless transition between the trial system and the permanent system.

[0025] The electrical pulses generated by the EPG and the IPG are delivered to one or more target nerves via one or more nerve stimulation electrodes at or near the distal end of each of the one or more leads. The leads have various shapes, are of various sizes, and are made of various materials, and these sizes, shapes, and materials are tailored to specific therapeutic applications. In this embodiment, the lead is sized and shaped to extend from the IPG through one of the foramina of the sacrum to the target sacral nerve, but in various other applications, the lead may be implanted in the peripheral portion of the patient's body, such as an arm or a leg, and configured to deliver electrical pulses to a peripheral nerve as used to relieve chronic pain. The lead wire and / or the stimulation program may vary depending on the nerve of interest.

[0026] To provide optimal and finely tuned alignment and to further improve the placement of the charging device on the patient, the system can include an alignment tool that can include alignment indicators on the user device or on the charging device itself, whereby the user can observe real-time indicators of coil alignment during manual positioning of the charging device. In this embodiment, the alignment tool is embodied in a separate professional user device 90 that communicates with a dedicated charging device 95 for charging the INS10, and the separate professional user device 90 can be used by a professional (e.g., a field technician, a representative of the device provider, a clinical care professional). This alignment function is particularly applicable to the sacral nerve stimulation system as described because the implantable pulse generator is implanted in the patient's lower back / upper buttocks and the patient may have difficulty seeing the placement during manual alignment of the charging device. In the embodiment of FIG. 1, the clinician programmer 60 includes an alignment indicator 61 configured to display an alignment indicator, which can be used to facilitate accurate placement of the charging device by the clinician viewing one or more charging parameters or associated charging metrics in real time during the charging operation. Alternatively, or in addition, the alignment indicator may be provided on the professional user device 90. In this embodiment, the alignment indicator is a charging efficiency indicator 91 based on one or more parameters received from the dedicated charging device 95 during charging of the INS10.

[0027] The implantable permanent system includes a charging device 50 configured to transcutaneously charge an implantable pulse generator by 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 in proximity to the implantable pulse generator, the charging device and the implantable pulse generator establish communication and initiate a charging protocol. When a positioning procedure is initiated in response to a request from an external user device 60, 90, the charging devices 50, 95 can output one or more charging parameters to their respective user devices or can utilize an alignment module separate from the charging module to determine a charging parameter or an alignment metric and output it to the external user device. Also, the charging devices 50, 95 can include an adhesive attachment device 52 or a charging belt 53 for maintaining the charging device 50 in a predetermined position on the patient during charging.

[0028] The clinician programmer 60 can include a control unit that includes a microprocessor and dedicated computer code instructions for implementing methods and systems for use by a physician in the deployment of a treatment system and the setting of treatment parameters. The clinician programmer generally includes a user interface, which may be a graphical user interface, and may further include audio and tactile functions. The clinician programmer 60 can be composed of dedicated software applications, such as alignment-exclusive software that determines and outputs an alignment indicator to guide the user through, for example, a fine-tuned charging device alignment procedure. As described above, the clinician programmer can include a module having hardware and computer code for performing an analysis of charging parameters to determine charging efficiency, where the module may be a component of the control unit microprocessor, a preprocessing unit coupled to or in-line with the stimulation and / or sensing cable, etc. 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 that may be a dynamically updated display of charging parameters or related metrics (e.g., charging efficiency) so that the clinician can observe the strength of the charging efficiency while manually adjusting the position of the charging device 50. In one aspect, the charging device is communicatively coupled to the clinician programmer 60 by short-wave wireless communication (e.g., Bluetooth), while currently communicating with the implantable pulse generator by another communication method (e.g., MedRadio). In some embodiments, the clinician programmer 60 obtains one or more charging parameters from the charging device 50 but does not change the charging operation based on the alignment determination. In some embodiments, the alignment indicator 65 can further provide a spatial illustration of the position of the charging device relative to the implantable medical device.In other embodiments, the clinician programmer can utilize various other means of indicating alignment, including but not limited to, tactile, visual (e.g., LED, graphic), or audio (e.g., beep or warning), to indicate optimized alignment. In some embodiments, the indicator can include multiple different types of notifications, or notifications that change as the charging device is adjusted and approaches an optimal placement. An alignment indicator that includes any of the features described above can be incorporated into the charging device itself, or provided on another user device, such as a patient's device, for example, a patient remote device or a personal computing device (e.g., smartphone, tablet). Each of the aspects described above with respect to the clinician programmer can similarly be applied to an expert user device 90 that is communicable with either the patient's standard charging device 50 or dedicated charging device 95.

[0029] Figures 2A - 2C are diagrams of various nerve structures of a patient that can be used for nerve stimulation therapy. Figure 2A shows various sections of the spinal cord and the corresponding nerves within each section. The spinal cord is an elongated bundle of nerves and supporting cells that extends from the brainstem along the cervical spinal cord, through the thoracic spinal cord, to the space between the first and second lumbar vertebrae of the lumbar spinal cord. When exiting the spinal cord, the nerve fibers branch into multiple branches that innervate various muscles and organs and transmit sensory and control impulses between the brain and the organs and muscles. Since certain nerves may include branches that innervate specific organs such as the bladder and branches that innervate specific muscles of the legs and feet, stimulating a nerve root close to the spinal cord or a nerve near it can stimulate the nerve branches that innervate the target organ, and as a result, muscle reactions related to the stimulation of other nerve branches may also occur. Therefore, by visually monitoring, using the EMG described herein, or both, and monitoring (monitoring) specific muscle reactions, a physician can determine whether the target nerve is being stimulated. Stimulation at a certain threshold may cause the indicated muscle reaction, but stimulation at a level below the threshold may provide stimulation to the nerves related to the target organ without causing the corresponding muscle reaction and, in some embodiments, without causing a sensory disorder. This is advantageous as it enables the treatment of pathological conditions by nerve stimulation without causing discomfort, pain, or unwanted muscle reactions in the patient.

[0030] Figure 2B shows the nerves related to the lumbar section in the lower lumbar spinal region where the nerve bundle exits the spinal cord and moves through the sacral foramina of the sacrum. In some embodiments, the nerve stimulation lead is advanced through the foramen until the nerve stimulation electrode is located on the anterior sacral nerve root, while the anchor portion of the lead proximal to the stimulation electrode is generally placed dorsal to the sacral foramen through which the lead passes to fix the lead in place. Figure 2C is a detailed diagram of the nerves of the lumbosacral trunk and the sacral plexus, particularly the S1 - S5 nerves of the lower sacrum. The S3 sacral nerve is of particular interest in the treatment of bladder - related dysfunction, particularly OAB.

[0031] Figure 3 schematically shows an example of a fully implanted nerve stimulation system 110 adapted for sacral nerve stimulation. The nerve stimulation system 100 includes an IPG implanted in the lumbar region and connected to a nerve stimulation lead that extends through the S3 foramen to stimulate the S3 sacral nerve. This lead is fixed by a tin-plated anchor portion 30 that maintains the position of a set of nerve stimulation electrodes 40 along the target nerve, which in this example is the anterior sacral nerve root S3 that innervates the bladder, to provide treatment for various bladder-related dysfunctions. This embodiment is adapted for sacral nerve stimulation, but a similar system can be used for the treatment of patients having, for example, chronic, severe, refractory neuropathic pain originating from peripheral nerves, or various urinary dysfunctions, or still other indications. The implantable nerve stimulation system can be used to stimulate either the target peripheral nerve or the epidural space posterior to the spine.

[0032] As shown in FIG. 3, the implantable pulse generator 10 of the INS is implanted in the patient's lumbar region, upper buttocks. The patient is generally instructed to place the charging device over a scar resulting from the incision made during implantation of the nerve stimulation device. However, the location of the scar in sacral nerve stimulation system implantation makes this task difficult because the patient cannot easily observe the scar during placement of the charging device. Further, in some patients, the position of the nerve stimulation device may change over time, for example, due to weight loss that often occurs after successful treatment. Thus, by disposing an alignment indicator function within a user device such as a clinician programmer, patient remote device, patient device, or expert device, the alignment indicator can be communicated to the user during manual alignment of the charging device, thereby enabling accurate placement without visually observing the position of the IPG. The scar may not indicate the proper position of the charging device, but the scar can still be used as a reference for a newly determined optimal position (e.g., 2 cm above / 3 cm to the right of the scar), which can be communicated to the patient for subsequent charging sessions.

[0033] The characteristics of the electrical pulses can be controlled via a control device of an implanted pulse generator. In some embodiments, these characteristics can include, for example, the frequency, intensity, pattern, duration, or other aspects of the electrical pulses. These characteristics can include, for example, voltage, current, etc. This control of the electrical pulses can include creating one or more electrical pulse programs, plans, or patterns, and in some embodiments, this can include selecting one or more existing electrical pulse programs, plans, or patterns. In the embodiment illustrated in FIG. 3, the implantable nerve stimulation system 110 includes a controller within the IPG having one or more pulse programs, plans, or patterns that are pre-programmed or created as described above. In some embodiments, these same characteristics associated with the IPG are used in the EPG of a partially implanted trial system used prior to implantation of the permanent nerve stimulation system 110.

[0034] FIG. 4 shows an exemplary nerve stimulation system 400 that is fully implantable and adapted for sacral nerve stimulation therapy. The implantable system 400 includes an IPG 10 coupled to a nerve stimulation lead 20 that includes a group of nerve stimulation electrodes 40 at the distal end of the lead and a group of internal receiving coils 15. The lead includes a lead anchor portion 30 having a series of teeth (tines) that extend radially outward to fix the lead and maintain the position of the nerve stimulation lead 20 after implantation. The lead 20 can further include one or more radiopaque markers 25 to assist in lead positioning and localization 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 nerve stimulation electrodes (typically four electrodes). In sacral nerve stimulation, the lead is typically implanted through the S3 foramen as described herein.

[0035] In one aspect, the IPG is wirelessly rechargeable via a conductive coupling by using a charging device 50, which is a portable device powered by a rechargeable battery so that the patient can move during charging. The charging device includes a charging coil 51 disposed therein and is used for transcutaneous charging of the IPG by RF induction. The charging device 50 can be attached to the patient's skin using an adhesive or held in place using a belt 53 or an adhesive patch 52. When recharging the IPG 10, the charging device 50 is positioned such that the surface 54 of the charging device 50 contacts the skin and the IPG 10 is recharged through the skin, parallel to and / or proximate to the skin where the IPG 10 is recharged, and can be held in place using the belt 53 or the adhesive patch 52. In such a position, the charging device axis, which may be perpendicular to the surface 54, may be perpendicular to the skin where the IPG 10 is recharged. The charging device 50 is charged by plugging the charging device directly into an outlet or by placing the charging device on a charging dock or station connected to an AC wall outlet or other power source.

[0036] The charging device 50 can include a housing. The housing can be of various shapes and sizes. In some embodiments, the housing may be cylindrical as shown in FIG. 4, specifically, it can consist of a plurality of connected cylindrical portions, and the connected cylindrical portions can have different diameters and / or lengths. In some embodiments, the housing 51 may be a polymer such as metal or plastic.

[0037] The charging device 50 can include a processor and / or memory adapted to provide commands to and receive information from other components of the implantable nerve stimulation system. The processor can include a microprocessor such as a commercially available microprocessor such as Intel® or Advanced Micro Devices, Inc.®. The charging device 50 can include an energy storage function such as one or more capacitors and typically includes a wireless charging unit. Some details of the charging device 50 are further described below in FIG. 7. The charging device can further include one or more position sensors such as an accelerometer to determine the relative position of the charging device and / or the direction of movement during repositioning. Any of the above features of the charging device 50 are shared by the dedicated charging device 95 (see also FIGS. 29-30). Preferably, the dedicated charging device includes a charging coil of the same size, shape and arrangement as the standard charging device 50 such that any optimal position of the dedicated charging device corresponds exactly to the standard charging device 50.

[0038] The system can further include a patient remote device 70 and a clinical medical programmer 60, each configured to wirelessly communicate with the implanted IPG and / or the EPG under test. The clinical medical programmer 60 can be a tablet computer used by a clinician to program the IPG and EPG. The device can also include a function for recording stimulus-evoked electromyogram (EMG) to facilitate lead placement, programming, and / or reprogramming. The patient remote device utilizes a radio frequency (RF) signal to communicate with the EPG and IPG, enabling the patient to adjust the stimulation level, check the status of the IPG battery level, and / or turn the stimulation on or off, and can be a battery-powered portable device.

[0039] Figures 5A - 5B are detailed diagrams of the IPG and its internal components. In some embodiments, the pulse generator can generate one or more non - ablative electrical pulses that are delivered to a nerve to control pain or cause some other desired effect, for example, to suppress, prevent, or disrupt nerve activity for the treatment of, e.g., OAB or bladder - related dysfunctions. In some applications, the pulses can have a pulse amplitude in the range between 0 mA and 1,000 mA, 0 mA and 100 mA, 0 mA and 50 mA, 0 mA and 25 mA, and / or any other range or intermediate range of amplitudes can be used. One or more of the pulse generators can include a processor and / or memory adapted to provide commands to and receive information from other components of the implantable nerve stimulation system. The processor can include a microprocessor such as a commercially available microprocessor such as Intel (trademark) or Advanced Micro Devices, Inc. (trademark). The IPG can include an energy storage function such as one or more capacitors and typically includes a wireless charging unit.

[0040] One or more characteristics of the electrical pulse can be controlled via the IPG or EPG controller. In some embodiments, these characteristics can include, for example, frequency, intensity, pattern, duration, or other aspects of the timing and magnitude of the electrical pulse. These characteristics can further include, for example, voltage, current, etc. This control of the electrical pulse can include creating one or more electrical pulse programs, plans, or patterns, and in some embodiments, this can include selecting one or more 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 are created and / or pre-programmed. In some embodiments, the IPG can be programmed to vary stimulation parameters including pulse amplitude in the range of 0 mA to 10 mA, pulse width in the range of 50 μs to 500 μs, pulse frequency in the range of 5 Hz to 250 Hz, stimulation mode (e.g., continuous or cycling), and electrode configuration (e.g., anode, cathode, or off) to achieve an optimal treatment outcome specific to the patient. This allows for determining an optimal setting for each patient, even though each parameter may vary from person to person.

[0041] As shown in FIGS. 5A to 5B, the IPG can include a header portion 11 at one end and a ceramic portion 14 at the opposite end. The header portion 11 houses a feed-through assembly 12 and a connector stack 13, and the ceramic case portion 14 houses an antenna assembly 16 for facilitating wireless communication with a clinician program and a patient remote device and / or a charging coil for facilitating wireless charging with a charging device. The remainder of the IPG is covered by a titanium case portion 17, which encloses a printed circuit board, a memory, and controller components that facilitate the above-described electrical pulse program. The ceramic portion 14 includes an end portion 23, a side surface 24, and a connecting portion 26 that connects the ceramic portion 14 to the case portion 17. In the example shown in FIG. 5B, the antenna assembly 16 is arranged such that the plane 28 on which the loop of the radiating element lies is perpendicular to the side surface 24 of the ceramic portion 14 and extends through the side surface 24 of the ceramic portion 14.

[0042] In some embodiments such as those shown in FIG. 5A, a ceramic-to-titanium brazed case is utilized at one end of the IPG where a ferrite coil and a PCB antenna assembly are disposed. The ceramic-to-metal brazing technique provides a highly reliable hermetic seal. The zirconia ceramic may be composed of 3Y-TZP (e.g., 3 mol% yttria-stabilized tetragonal zirconia polycrystal) ceramic, has high flexural strength and impact resistance, and is commercially utilized in many implantable medical technologies. However, other ceramics or other suitable materials may be used in the construction of the IPG, and ceramics may be used in forming additional portions of the case.

[0043] In one aspect, by utilizing a ceramic material, the communication antenna is housed within a sealed ceramic case, providing an efficient high-frequency transmission window for wireless communication with an external patient remote device and a clinician programmer. This ceramic window further promotes miniaturization of the implant while maintaining an efficient high-frequency transmission window for long-term reliable wireless communication between the IPG and external controllers such as patient remote devices and clinician programmers. The wireless communication of the IPG is generally stable throughout the life of the device, unlike prior art products where the communication antenna is placed within a header outside the sealed case. The communication reliability of such prior art devices tends to decrease due to the time-dependent change in the dielectric constant of the header material within the human body.

[0044] In another aspect, the ferrite core is part of the charging coil assembly 15 shown in FIG. 5B and is disposed within the ceramic case 14. The ferrite core concentrates the magnetic field magnetic flux through the ceramic case, in contrast to the metal case portion 17. This configuration maximizes the coupling efficiency, reduces the required magnetic field, and thus reduces device heating during charging. In particular, since the magnetic field magnetic flux is directed perpendicular to the metal cross-sectional area with the minimum magnetic field, heating during charging is minimized. Also, with this configuration, when placed on the skin surface of a patient near the IPG, the IPG can be effectively charged at a depth of 3 cm with a charging device, reducing the recharge time.

[0045] FIG. 6 is a schematic diagram showing an embodiment of the architecture of the IPG 10. In some embodiments, each of the components of the architecture of the IPG 10 is implemented using the processor, memory, and / or other hardware components of the IPG 10. In some embodiments, the components of the architecture of the IPG 10 can include software that interacts with the hardware of the IPG 10 to achieve the desired results, and the components of the architecture of the IPG 10 are disposed within the housing.

[0046] In some embodiments, the IPG 10 can include, for example, a communication module 600. The communication module 600 is configured to transmit data to and receive data from other components and / or devices of an exemplary nerve stimulation system, including, for example, a clinician programmer 60, a charging device 50, and / or a patient remote device 70. In some embodiments, the communication module 600 can include one or more antennas and software configured to control the one or more antennas to transmit information to and receive information 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 is configured to transmit data identifying the IPG 10 and / or data characterizing one or some attributes of the IPG 10. In some embodiments, this information can be a number that uniquely identifies the IPG 10, such as, for example, a serial number. In some embodiments, this data can characterize one or some attributes of the IPG 10, such as, for example, the natural frequency of the charging module 606 of the IPG 10 and / or the natural frequency of one or some components of the charging module 606 of the IPG. In some embodiments, the IPG 10 can be configured to communicate one or more charging parameters to a user device during charging, including any of a clinician programmer, a patient remote device, or a portable patient computing device, and thereon, an alignment indicator can be provided based on the one or more charging parameters.

[0047] The IPG10 can further include a data module 602. The data module 602 is configured to manage data related to the identification and characteristics of the IPG10. In some embodiments, the data module can include one or several databases that can, for example, contain information related to the IPG10, such as the identification of the IPG10, one or several characteristics of the IPG10, etc. In one embodiment, the data for identifying the IPG10 can include, for example, the serial number of the IPG10 and / or other identifiers of the IPG10, such as the unique identifier of the IPG10. In some embodiments, the information related to the characteristics of the IPG10 can include, for example, data for identifying the function of the IPG10, data for identifying the power consumption of the IPG10, data for identifying the charging capacity and / or the power storage capacity of the IPG10, data for identifying the potential charging rate and / or the maximum charging rate of the IPG10, etc. In some embodiments, the information related to the characteristics of the IPG10 can include, for example, data for identifying the natural vibration frequency of the IPG10 and / or its components. In some embodiments, this information for identifying the natural vibration frequency is generated during the manufacture of the IPG10.

[0048] The IPG10 can include pulse control 604. In some embodiments, the pulse control 604 is configured to control the generation of one or several pulses by the IPG10. In some embodiments, for example, this is performed based on information identifying one or several pulse patterns, programs, etc. This information can further specify, for example, the frequency of the pulses generated by the IPG10, the duration of the pulses generated by the IPG10, the intensity and / or magnitude of the pulses generated by the IPG10, or any other details related to the generation of one or several pulses by the IPG10. In some embodiments, this information can specify aspects of the pulse pattern and / or pulse program, such as the duration of the pulse pattern and / or pulse program. In some embodiments, information related to and / or for controlling the pulse generation of the IPG10 can be stored in memory.

[0049] The IPG10 can include a charging module 606. In some embodiments, the charging module 606 is configured to control and / or monitor the charging / recharging of the IPG10. In some embodiments, for example, the charging module 606 can include one or more functions configured to receive energy for recharging the IPG10, such as one or more inductive coils / functions that interact with one or more inductive coils / functions of the charging device 50 to generate an inductive coupling by which the IPG10 can be recharged. In some embodiments, the charging module 606 can include hardware and / or software configured to monitor the charging of the IPG10, including, for example, the charging coil assembly 15, also referred to herein as the receiving coil assembly 15 or the elongated receiving coil assembly 15. In some embodiments, the software of the charging module is periodically updated, for example, in a software push via an external computing device communicating with the communication module. Typically, the communication module provides secure authentication for any communication regarding software updates such that any software updates are communicated only when secure, authenticated communication, such as communication from an authorized clinician programmer or communication with an authorization key from a network or remote server, is received.

[0050] The charging module 606 of the IPG10 can include a charging circuit 607, which is 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 is composed of, for example, at least one of an inductor, a capacitor, or a resistor. The charging circuit 607 is characterized by a natural frequency, which is determined, for example, during the assembly of the charging circuit 607 or after the IPG10 is implanted into the body. In some embodiments, since the temperature and environment in the body are relatively constant, the natural frequency of the charging circuit 607 can remain constant even after the IPG10 is implanted into the body. The IPG10 can further include an energy storage device 608, which, in this embodiment, is a rechargeable battery configured to receive charging energy from the charging module 606.

[0051] FIG. 7 is a schematic diagram showing an embodiment of the architecture of the charging device 50. The features described in the following paragraphs can similarly be applied to a dedicated charging device 95. In some embodiments, each component of the architecture of the charging device 50 is implemented using the 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 can include software that interacts with the hardware of the charging device 50 to achieve the desired results, and the components of the architecture of the charging device 50 are arranged within the housing 51.

[0052] In some embodiments, the charging device 50 can include, for example, a communication module 600. The communication module 700 is configured to transmit data to and receive data from other components and / or devices of an exemplary nerve stimulation system, including, for example, a clinician programmer 60, an IPG 10, and / or a patient remote device 70. In some embodiments, the communication module 700 can include one or more antennas and software configured to control the one or more antennas to transmit information to and receive information from one or more of the other components of the charging device 50. In some embodiments, the charging device communicates with the IPG during charging via a first antenna and communicates one or more charging parameters or associated metrics to a user device via a second antenna. In some such embodiments, the first antenna can communicate with the IPG via MedRadio, and the second antenna can communicate with the user device via Bluetooth (trademark). In some embodiments, when connecting to the IPG 10, the communication module 700 is configured to receive data that identifies the IPG 10 and / or data that characterizes one or more attributes of the IPG 10. In some embodiments, this information can be a number that uniquely identifies the IPG 10, such as, for example, a serial number.

[0053] The charging device 50 can further include a data module 702. The data module 702 is configured to manage data related to the identification and characteristics of the IPG10. In some embodiments, the data module can include, for example, one or several databases that can include information related to the IPG10, such as the identification of the IPG10, one or several characteristics of the IPG10. In one embodiment, for example, the data module can configure a database that includes one or several IPG10 identifiers, such as the serial numbers of those one or several IPG10s. In some embodiments, the data module 702 can further include characteristic data related to some or all of the one or several IPG10s identified in the data module 702. In some embodiments, for example, this characterization data can include the identification of the natural frequency of the charging circuit 607 of the IPG10. In some embodiments, this characteristic data may be received from the IPG10 and / or generated by the charging device 50 in response to the interaction with the IPG10. In some such embodiments, the data module provides, for example, the separation of data between the charging parameters used during charging control and the charging parameters transmitted to the user device. Such an approach enables the user device to access data and processes that would otherwise be infeasible or not recommended, in order to avoid unauthorized access to charging control operations by the patient or clinician.

[0054] The charging device 50 can include a charging module 704. In some embodiments, the charging module 704 is configured to control and / or monitor the charging / recharging of the IPG 10. In some embodiments, for example, the charging module 704 can include one or more functions configured to provide energy for recharging the IPG 10, such as one or more inductive coils / functions that interact with one or more inductive coils / functions of the IPG 10 to generate an inductive coupling for recharging the IPG 10. In some embodiments, the charging module 704 can include hardware and / or software configured to monitor the charging of the IPG 10, including, for example, the charging coil assembly 15.

[0055] The charging module 704 of the charging device 50 can 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 can include, for example, at least one of an inductor, a capacitor, or a resistor. In some embodiments, the resonant circuit 706 can include a transmitter coil assembly, also referred to herein as a transmitter coil assembly or a primary coil assembly.

[0056] In some embodiments, the charging module 704 can include a driver 708. The driver 708 can be, for example, a non-Class E driver, and in some embodiments, the driver 708 can be a Class E driver, specifically, a microprocessor-controlled Class E driver as disclosed in U.S. Patent Application No. 14 / 446,294, filed Jul. 29, 2014, which is hereby incorporated by reference in its entirety. In some embodiments, the driver 708 is configured to supply electrical pulses to the resonant circuit 706, thereby charging the IPG10. In some embodiments, the driver 708 may be further configured to provide these pulses at a frequency corresponding to the natural frequency of the resonant circuit 706. Thus, 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 supplies pulses to the resonant circuit 706.

[0057] The charging device 50 can include an energy storage device 710. The energy storage device 710 can be any device and / or function configured to store energy, and can include, for example, one or more batteries, capacitors, fuel cells, etc. In some embodiments, the energy storage device 710 is configured to provide charging energy to the charging module 704 for charging the IPG10. In this embodiment, the energy storage device 710 is a rechargeable battery that is inductively recharged by a charging dock that is stored when the charging device is not in use.

[0058] For example, in some embodiments where at least one of the axes 802, 809 is parallel and / or substantially parallel to the skin surface closest to the IPG10 and / or the IPG10 is implanted such that charging of the IPG10 is intended, the use of the planar winding 852 in the charging device 50 in combination with the elongated winding 800 within the IPG10 can eliminate the need to control the rotational orientation of the charging device 50 with respect to the IPG10. Thereby, the positioning of the charging device 50 with respect to the IPG10 can be simplified. Specifically, when the IPG10 and the charging device 50 have a relative orientation such that the axes 802, 809 of the charging circuit 15 of the IPG10 are non-parallel with respect to the winding axis 854 and / or the core axis 864, and / or when the IPG10 and the charging device 50 have a relative orientation such that the axes 802, 809 of the charging circuit 15 of the IPG10 are perpendicular and / or substantially perpendicular to the winding axis 854 and / or the core axis 864, the influence of the relative rotational orientation of the charging device 50 with respect to the IPG10 is reduced. In such embodiments, effective energy transfer between the charging device 50 and the IPG10 can be achieved by positioning the charging device 50 in proximity to the IPG10 without controlling the rotational orientation of the charging device 50 about the charging device axis 55. Since there is no need to control the rotational direction of the charging device 50, the positioning of the charging device 50 for recharging the IPG10, and thus the recharging of the IPG10, is simplified.

[0059] As part of, or subsequent to, the positioning of the charging device 50 relative to the IPG10, the charging device 50 can supply power to the transmission coil assembly 850. Specifically, the charging module 704 can supply power to the transmission coil assembly 850. In some embodiments, this power supply to the transmission coil assembly 850 can include the generation of a series of pulses by the driver 708, and the pulses are timed to cause resonance in the charging circuit 706. These pulses are then supplied to the charging circuit 706 to cause resonance in the charging circuit 706 at the resonant frequency of the charging circuit 706 and / or at another desired frequency. Through this power supply to the charging circuit 706 and the current oscillation in the charging circuit 706, a magnetic field may be generated by the transmission coil assembly 850. The magnetic field may be directed away from the circuit 870 of the charging device 50 by the core 862 of the power transmission coil assembly 850. The magnetic field can be generated until the charging device 50 determines to end the charging of the IPG10 and / or until the charging device 50 is instructed to end the charging of the IPG10. Thus, the charging operation during the positioning of the charging device may be standard operation charging or, for example, a modified charging operation particularly suitable for the arrangement of the charging device as described above.

[0060] FIG. 8 is a schematic diagram of a system 800 having an IPG 80, a charging device 802 (e.g., a standard or dedicated type), and an alignment indicator 803, according to some embodiments. In this embodiment, the charging device 802 communicates directly with the implantable pulse generator 801 through the patient's skin to facilitate controlled transcutaneous energy transfer between the charging device and the implantable device. Typically, this transcutaneous communication is performed by shortwave wireless communication (e.g., MedRadio). The charging device 801 then communicates one or more charging parameters to the alignment indicator 803, which may be displayed on the user interface of one or more external computing devices or may be incorporated within the charging device itself. Typically, this latter communication is performed by another type of shortwave wireless communication (e.g., Bluetooth). In some embodiments, the alignment indicator utilizes information obtained only from the charging device among the information including the charging parameters from both the charging device and the implantable pulse generator during charging. In some embodiments, the alignment indicator can also include information obtained directly from the implantable pulse generator or information obtained from both.

[0061] FIG. 9 is a schematic diagram of a system 900 having a charging device 910 with a charging coil 911 and a charging module 912 having a circuit and a processor configured to control transcutaneous charging by an IPG. The charging module 912 is further configured to communicate one or more charging parameters p(s) during charging to an external user device 920 in response to a request from an external device. The external device 902 indicates alignment on a user interface as an alignment indicator 921. The indicator can include any of an audio, visual, or tactile output on the 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 representative of the device provider), while in other embodiments, the user device can be associated with a clinician (e.g., a clinician programmer) or a patient (e.g., a patient remote device, a smartphone, a tablet). In this embodiment, the alignment indicator may be a display of a charging parameter or an associated metric (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 already acquired and determined by the charging module during a standard charging operation such that no further processing of the parameters or metrics by the external device is required.

[0062] FIG. 10 is a schematic diagram of a system 1000 having a charging device 1010 with a charging coil 1011 and a charging module 1012 having a circuit and a processor configured to control transcutaneous charging by an IPG. The charging module 912 is further configured to communicate one or more charging parameters p(s) to an external device 1020 during charging. The external device 1020 indicates alignment on a user interface as an alignment indicator 1022. The indicator can include any of an audio, visual, or tactile output on the user interface of the external device 920. In some embodiments, the external user device 1020 is associated with an expert, while in other embodiments, the device is associated with a clinician or a patient. In this embodiment, the external device is configured to receive charging parameters and process the parameters into a useful metric such as charging efficiency or determine an appropriate alignment indicator based on one or more charging parameters, and further includes an alignment module 1021.

[0063] FIG. 11 shows a schematic diagram of an external device 1120 having an alignment indicator 1121 that operates in a substantially identical or similar manner to FIG. 10, except that a charging module 1111 and an alignment module 1112 are included within the charging device 1110. In some embodiments, this functionality is provided by a software push update from the external device to the charging device.

[0064] FIG. 12 is a schematic diagram of a charging device integrated with an alignment indicator. The charging device 1210 includes a charging module 1212, an alignment module 1213, and an alignment indicator 1214, and the indicator operates in a manner similar to the above-described embodiments, except that the output of the alignment indicator is provided by the charging device itself. The indicator can include any of audio, visual, or tactile output on the 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 a verbal instruction to the user by voice. In this embodiment, it is advantageous to use different types of indicator warnings, or adaptive warnings based on charging parameters, such as a series of beeps whose frequency increases as the charging efficiency increases, and / or a continuous beep that changes when the maximum charging efficiency is detected to indicate the optimal charging device position.

[0065] In another aspect, the charging device can include one or more position sensors 1215, such as an accelerometer, and the output therefrom can be used to determine the relative position or movement of the charging device during manual positioning of the charging device. The position sensor is included in any of the embodiments described herein. The output from one or more sensors can be utilized to determine specific direction guidance for the user or clinician, such as an instruction to move the charging device upward, leftward, or rightward to improve alignment. In some embodiments, the sensor can identify the rotational direction of the charging device so that the user can receive an instruction to rotate the charging device to further align the corresponding coil. Note that as described in U.S. Patent No. 10,682,521, which is hereby incorporated by reference in its entirety, the adhesive attachment device and belt allow rotation of the charging device while being supported internally. In some embodiments, the attachment device can further include more than one sensor such that the relative position and / or orientation of the internal charging device is determined from the sensor position output.

[0066] In another aspect, the subject matter 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 may be any of an expert device related to a nerve stimulation system, a clinician programmer, a patient remote device, or other expert medical device. In some embodiments, the external computing device may be a standard computing device related to an expert, clinician, or patient, such as a smartphone, tablet, laptop, or desktop computer, and the functionality for performing the methods described herein is at least partially provided by the operation of a dedicated application embodied by executable instructions recorded on the memory of each user device.

[0067] 13-18 illustrate exemplary screen views of a user device within a dedicated application having an alignment indicator located within the user device, according to some embodiments. The dedicated application performs a charging device alignment procedure that allows an expert or clinician to observe a finely tuned alignment while the user manually adjusts the position of the charging device. This procedure can be used at any time thereafter, during the initial setup of the system by the patient, as needed, or to troubleshoot charging problems, such as when the patient experiences movement of the implanted charging device or significant weight loss and only sub-optimal charging performance is obtained.

[0068] As shown in FIG. 13, the external user device initiates a finely tuned charging device alignment procedure by 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 the antenna of the charging device. Typically, the devices communicate by short wavelength UHF radio waves such as Bluetooth. The charging device and the external user device establish secure communication by a permission procedure or handshake that, for example, exchanges identification information with a clinician programmer to ensure that the charging device is communicating with an authorized device and that information from the charging device is secure.

[0069] As shown in FIG. 14, the alignment procedure outputs a screen display 1400 for fine alignment including an alignment indicator 1401 on the graphical user interface display of the user device to facilitate fine alignment of the charging device during charging. When the charging device performs a charging operation, the interface displays the alignment indicator in real time and is constantly updated while the user manually adjusts the charging device, enabling 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 may be determined from the corresponding charging parameters already obtained by the charging device during charging. For example, the charging efficiency may be determined by comparing the output power of the charging device with the charging power generated in the implanted medical device. By observing the charging efficiency while manually adjusting the charging device through an appropriate range of positions during charging, the alignment between the coil of the charging device and the implanted device can be finely adjusted to find the optimal charging position. Once the optimal position is found, that position is recorded by the user, by a clinician's note created by the clinician programmer, and / or by a photograph taken by the clinician programmer and saved on the user device, and then notified to the clinician and the patient. The optimal position information may be saved by the user device and associated with the patient so that the patient or clinician can access the optimal position information at a later date, and the patient can continue to reproduce this optimal position during subsequent charging sessions.

[0070] As shown in FIG. 15, an external user device display 1500 with an alignment indicator 1501 can also display the maximum or peak charging efficiency detected during the alignment procedure so that a clinician and a patient can be easily identified when they reach the optimal position. This information can be communicated by various other means, such as, for example, a dedicated charging metric specific to the nerve stimulation system, a simplified evaluation system (levels 1 to 5) for evaluating charging efficiency, or an audible warning (e.g., instructions, beeps, tones), or any suitable means. In some embodiments, the indicator 1501 can include an additional display (e.g., warning, beep, tone) when the current charging efficiency is at the detected maximum charging efficiency or the target charging efficiency. In some embodiments, the external user device is configured to determine a target value and / or range for the alignment indicator (e.g., via a dedicated application). This value may be one or more charging parameters, the relationship between the parameters (e.g., efficiency), or a quantitative measure (e.g., ranking, scale, etc.). In some embodiments, this target value and / or range is determined as a function of any of the history of alignment indicator values; the history of one or more charging parameters; and the associated charging metrics. In some embodiments, the history used to determine the target value and / or range is from a given charging session. In other embodiments, the history is from multiple sessions (e.g., two or more sessions, a set number of most recent sessions (e.g., 3, 4, 5), all charging sessions for a selected period (e.g., weeks, months, years), or all previous charging sessions). In some embodiments, the target range is smaller than the total range of values determined in the charging session. 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, output the history of the alignment indicator to the user as a chart or other visual, and / or determine trends regarding 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, healthcare provider, or device manufacturer. As shown in FIG. 16, an external user device display 1600 with an alignment indicator can further include an instruction or guidance 1601 to the user to further facilitate fine-tuning of the alignment. For example, if the current charging efficiency indicates that charging is not optimal, the guidance can instruct the user to further adjust the position of the charging device.

[0071] As shown in FIG. 17, an external user device display 1700 with an alignment indicator can further include a direction instruction or guidance 1701. The direction guidance can include specific instructions on how to adjust the charging device, such as instructions to move the charging device up / down / left / right by a suggested distance, or instructions to rotate the charging device. This guidance may be notified by a position sensor disposed on the charging device, such as one or more acceleration sensors, as described herein. And the guidance can be shown to the user when the optimal position is detected.

[0072] As shown in FIG. 18, the fine-tuned alignment procedure may be performed on a small user device (e.g., a smartphone) 1800 of a patient, expert, or clinician, and can include any of the features of the alignment procedure described herein. In this embodiment, the alignment indicator includes a direction guidance 1801 provided in combination with an audio warning. For example, the user is audibly instructed to move the charging device (e.g., slowly move the device left / right / up / down or by an estimated distance). In some embodiments, the warning can change during adjustment of the charging device so that the user can identify when the optimal position is reached. For example, the beep sound increases as the charging efficiency increases and changes to a continuous beep sound when the maximum efficiency is detected.

[0073] This approach has the advantage that the user can finely adjust the placement of the charging device within the home as needed. In some embodiments, the patient can perform fine-tuned charging by using a dedicated application on their personal device. In other embodiments, the patient's device can communicate via a network with both the charging device and an expert device or clinician programmer so that an expert or clinician can remotely facilitate fine-tuning through the patient's device. In some embodiments, the fine-tuned alignment procedure may be at least partially automatically initiated when charging begins to be insufficient. For example, as the patient loses weight and daily charging becomes increasingly insufficient, the patient's personal computing device (e.g., smartphone, tablet) can initiate a proposal or warning to the patient to perform a fine-tuned alignment of the charging device, guide the patient through the procedure on the personal computing device, or facilitate the remote execution of the procedure by an expert, clinician, or healthcare provider using the patient's personal computing device that communicates with the clinician's computing device via a remote server or network.

[0074] Figures 19-20 illustrate an exemplary method of charging an embedded device with a charging device and an alignment indicator, according to some embodiments.

[0075] As shown in Figure 19, the method can include starting a fine-tuned charging device alignment procedure on an external device 1901, establishing communication between the charging device and an external device 1902, performing a charging operation at a charging device 1903 and communicating one or more charging parameters to the external device, determining a charging efficiency from the charging parameters at an external device 1904, and outputting an alignment indicator in real time based on the charging efficiency at the external device during adjustment of the position of the charging device 1905. The alignment indicator can include one or more of the features described herein, or combinations thereof (e.g., visual, audible, tactile).

[0076] As shown in FIG. 20, such a method can include the steps of positioning a charging device in the vicinity of an implantable medical device (IMD) 2001 for the user; outputting, from the charging device or an external device, a first indicator indicating the position of the charging device in a vicinity sufficient for charging at 2002; performing a charging operation; determining a charging efficiency from charging parameters by the external device or the charging device at 2004; and outputting, from the charging device or the external device, a second indicator indicating a fine-tuned alignment of coils between the charging device and the IMD based on the charging efficiency at 2005. The alignment indicator can include one or more functions described herein and combinations thereof (e.g., visual / audio / tactile) are also possible.

[0077] In another aspect, the functionality of the charging device with respect to any of the alignment indicator features herein can be affected by a software push via an external user device that communicates with the charging device, such as an expert device, a clinician programmer, or the patient's personal computing device (e.g., smartphone). In some embodiments, dedicated software configured for fine-tuning alignment can facilitate a software push to the charging device via a clinician programmer or the patient's personal computing device. In some embodiments, a dedicated software application can be configured to upgrade the software on an implanted medical device (e.g., IPG) from the user device via the charging device while the charging device is positioned on the patient's body over the IPG (e.g., immediately before charging, during charging, or after charging). The upgrade can include functions related to charging alignment and / or various other functions unrelated to charging alignment. In another aspect, periodic communication between the user device and the charging device during a charging session can be utilized for various ancillary functions including programming of a stimulation profile from the user device (e.g., transmitted by a clinician or to the patient's user device by a clinician) and / or downloading of a data log from the implanted device.

[0078] In one aspect, the charging device alignment function described herein is incorporated into a dedicated software application (e.g., SmartCharge App) that is operable on the computing device of an expert, clinician, or patient to facilitate the alignment of the charging coils of the charging device and the 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 the patient's device to assist the patient in improving the alignment of the implanted medical device and the charging device. In some embodiments, the user connects an external user device (e.g., a smartphone / tablet / laptop) to the charging device for local communication (e.g., via Bluetooth) and uses a dedicated software application to monitor the charging data and efficiency between the charging device and the implanted medical device.

[0079] In some embodiments, the charging device alignment tool is a dedicated application (e.g., SmartCharge App) separate from the standard everyday charging application that the patient uses during everyday charging. In some embodiments, the dedicated alignment application is configured for use by experts only. Thus, this dedicated charging device alignment application can guarantee the appropriate permissions and authentication of each device by utilizing a special login. A flowchart of the login protocol is shown in FIG. 21, and an exemplary login screen is shown in FIG. 22.

[0080] FIG. 21 shows a decision tree of an exemplary login flowchart embodied in programmable instructions of a software application stored in a user device. The flowchart includes a step (1) of starting the application and a step (2) of displaying a login screen (see, e.g., FIG. 22), through which identification information (e.g., the serial number of the charging device) is input via the user interface of the user device before a wireless connection (e.g., via Bluetooth) is started by pressing a “Connect” button. Next, the software application executes a step (3) of evaluating whether wireless communication (e.g., Bluetooth) is active on the user device. If not active, step (4) notifies the user that it is necessary to turn on the wireless communication and returns to step (2). If active, the program executes a step (6) of wirelessly connecting the user device to the charging device and displaying an action indicator (e.g., “Connecting to charging device”). Next, the software application executes a step (7) of evaluating whether the charging device is connected to the user device. If not connected, the software application displays an error message on the user device (e.g., “The charging device cannot be detected. Please check the entered serial number and make sure the power of the charging device is on”). If connected, the software application executes a step (9) of proceeding to the main display screen and performs charging alignment (see the screens of FIGS. 23-24).

[0081] FIG. 22 shows a login screen 2200 of a charging device alignment tool application on a user device. This screen displays instructions to the user to start charging device alignment as described herein. These instructions to the user include 1) ensuring that the user device includes valid 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 charging 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. On login, the user is provided with a button to wirelessly connect the user device to the charging device. In some embodiments, this login screen is compatible with the conventional touch screen interface of a dedicated smartphone or tablet device, and in other embodiments, the software application can be used with standard personal devices (e.g., smartphone / tablet).

[0082] FIG. 23 shows an exemplary main screen 2300 of a dedicated alignment application (e.g., "SmartCharge") to facilitate fine-tuned charging alignment. This main screen displays various indicators related to the battery, connection, and charging status to enable fine-tuned alignment of the charging coil based on one or more charging parameters obtained from the charging device. On the main display, the back button (e.g., left arrow) in the upper left returns the user to the charging device login screen of FIG. 22 and disconnects the charging device from the user device until the "Connect" button is pressed again. Below the back button is a battery / charging status indicator 2301, indicating that the status is "charging" and the battery capacity is 62%. At the top of the main screen is a connectivity indicator 2305, with a green circle displayed indicating that the user device is communicably coupled to the implanted nerve stimulation system (INS). If the INS loses connectivity with the user device, the main screen displays a status indicator 2031' (see the upper left details displayed as "Searching for INS..."), and the connectivity indicator 2035' is displayed as a gray bar indicating no connection. The main screen further includes a charging time indicator 2302 showing the charging time parameters. This indicator may be included in a collapsible menu titled "Estimated Time". Usually, the estimated remaining time is updated periodically (e.g., every 30 seconds, every minute). The main screen further includes a charging efficiency history indicator 2303 shown on the right, which shows the history or log of the charging efficiency over a certain period during the charging period. The history of charging efficiency is typically shown as a graph but can also be shown as a series of bars. The main screen further includes a current charging efficiency level indicator 2304 shown at the bottom, which shows the current real-time charging efficiency and can further show the standard charging range and peak. When the INS is fully charged, "Fully Charged" is displayed in the upper left header, and the following pop-up notification is displayed: "This INS is fully charged. The session has ended.To use Smart Charge with this INS, please wait until the charge level decreases below 90%.

[0083] In one aspect, the historical charge efficiency indicator 2303 can show the variation of charge efficiency over the elapsed time during charging. In the embodiment of FIG. 23, the period is 60 seconds. The graph is continuously updated to reflect the latest period of elapsed time, so that the user can observe the variation during charging when the charging device is actively moving. In this embodiment, the graph is a bar that animates to the right, and the value at the right end is the latest charge level. The peak efficiency can be marked on the graph with a straight horizontal line across the graph, which indicates the highest efficiency achieved during the charging session.

[0084] FIG. 24 shows an alternative main screen 2400 of a dedicated charge alignment software application. Similar to that of FIG. 23, the main screen shows a connection status indicator 2405, a charge / battery status indicator 2401, a charge time indicator 2402 (indicating a drop-down menu title), a charge efficiency history indicator 2403, and a current real-time charge efficiency level indicator 2404 with a standard range and peak level indicator. FIGS. 25-27 show detailed views of the selected indicator, as well as additional charge level indicators based on the percentage charged and the rotational alignment.

[0085] FIG. 25 shows a charge time indicator 2502 that shows the time parameters of the estimated remaining time and the estimated full charge time. In this embodiment, the indicator is displayed within a collapsible menu. In some embodiments, the estimated remaining time is determined based on the average steady-state charge rate and the initial battery capacity at the start of the charging session. In some embodiments, the initial battery capacity is determined based on the battery voltage measurement obtained from the charging device by the user device. The software application determines the total estimated time to perform a full charge and the continuously updated estimated remaining charge time.

[0086] FIG. 26 shows the charging efficiency indicator 2601. In this embodiment, the level is indicated by contrasting colors (e.g., green vs. gray) according to the percentage. Typically, the target efficiency is levels 3 to 5 (shown in green), contrasted with the lower, sub - optimal efficiency levels 1 and 2 (shown in gray). FIG. 17 shows the rotational charging efficiency indicator 2701 that indicates the charging efficiency level associated with each rotational alignment. Usually, this indicator is observed while the charging device stays in a position and is rotated by the user to facilitate the optimal rotational alignment condition between the INS and the charging device. In this embodiment, the rotational alignment may be at a reference position (e.g., the initial position) or may be determined relative to a reference (e.g., the rotational angle in the clockwise direction).

[0087] FIG. 28 is a detailed view of the current charging efficiency level indicator 2800, which shows the current charging efficiency level as a bar, e.g., an animated bar representing the charging efficiency determined in real - time. The bar can extend between different charging efficiency levels from level 1 to level 6. The typical standard range of charging efficiency 2802 indicates the expected efficiency and can guide the clinician and / or patient during positioning. The bar graph can further include a peak level indicator 2803 (e.g., a vertical bar) that indicates the highest charging level determined during the charging session.

[0088] In another aspect, the charging alignment tool and related software application may be specifically configured for use by experts (e.g., field technicians, representatives of device providers, clinical experts). For example, the software application described herein may be provided with an expert-only login access for use on the expert's user device for patient training purposes and / or for troubleshooting charging alignment problems experienced by a particular patient. In some embodiments, the dedicated alignment application is configured to be used with a dedicated charging device having advanced charging functions for streamlining the charging alignment procedure.

[0089] In some embodiments, the alignment application provides real-time feedback to experts (e.g., field technicians, sales floor team members, device provider representatives, clinical experts) regarding the quality of alignment between the charging device and the INS in order to optimize patient charging through high-quality patient education and training or to enable advanced troubleshooting including cases where the INS is in sleep mode or suspended. This approach of housing the functionality of the alignment tool only on the expert device improves the patient experience while minimizing the occurrence of unnecessary device revisions and updates in standard equipment and applications used by clinicians and patients.

[0090] In one aspect, the charging alignment setup can utilize a dedicated charging device that has additional functionality compared to a standard charging device. FIG. 29 shows a system that utilizes an expert device 300 with a display 310 and a dedicated charging device 95 (e.g., a "green charging device") operable to communicate charging parameters to the device 300 to display alignment indicators on the display 310. In such an embodiment, the dedicated charging device can include additional communication capabilities (e.g., Bluetooth compatibility) to communicate with a user device (e.g., an expert's user device), while most standard charging devices for patients do not require this functionality. Similarly, the software application may be configured to be operable only on a user device accessed by an expert. In some embodiments, the software application is configured to display at least battery status information and a charging efficiency indicator for the charging connection between the charging device and the INS. The display can further include charging time parameters or a charging efficiency history as described above.

[0091] FIG. 30 shows the dedicated charging device 95 connected to a dedicated software application on the expert's user device 310. An initial login screen similar to FIG. 22 is displayed on the user display 310 to facilitate an initial connection to the dedicated charging device. In some embodiments, if the INS battery is depleted and in the hibernate mode, some charging is required before the dedicated application can communicate with the INS.

[0092] After connection, the charging device can be used in the normal way to start wireless charging of the INS. The dedicated application communicates with the dedicated charging device via local communication (e.g., Bluetooth (trademark)), obtains charging parameters for determining and displaying the charging efficiency level, and the charging parameters are used to determine a more efficient charging position of the charging device on the patient. More efficient charging means fast charging with fewer disconnections. The charging efficiency is determined as follows. That is, it is determined by the depth of the INS, the position of the charging device, and the rotation of the charging device.

[0093] During charging, the alignment application displays a main screen (see FIGS. 23-24) on the display 310 of the specialist device 300 and shows various indicators related to charging. In the embodiment shown in FIG. 31, 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 can show the battery / charging status 301a (e.g., 87%) and the charging status (e.g., "charging"), the INS serial number 301b, and the charging device serial number 301c. As shown in FIG. 32, the current efficiency level indicator 304 (as described in FIGS. 23-24) can extend across five charging levels from lowest to highest. Levels 1 and 2 correspond to sub-optimal charging levels where the primary alignment is sufficient for charging but the secondary alignment degrades the charging efficiency. Levels 3 and 4 correspond to optimized charging levels where the secondary alignment is improved and the charging efficiency is enhanced. Most patients charge at levels 3 and 4 efficiency within the "standard range" to achieve the expected charging time. In some embodiments, the system may be configured with a level 5 corresponding to accelerated charging. The dedicated charging device may be specifically configured in an accelerated charging mode that can charge faster than the standard mode of a standard charging device used by the patient. Level 5, accelerated charging, may not be achievable or necessary for all patients. This mode may further improve the visibility of the optimal alignment position. In some embodiments, this accelerated charging function allows the charging device to charge a dormant INS more quickly and wake it up. In some embodiments, after the INS is fully charged and the connection is established, the dedicated charging device charges at the same speed as the standard charging used by the patient.

[0094] While the charge state / efficiency indicator is displayed to the expert on the main screen of the user device, the user moves the charging device as shown in FIGS. 33 and 34. The following instructions may be provided via a dedicated app or by instruction materials provided with the dedicated app and / or dedicated charging device. FIG. 33 shows the user slowly moving the charging device up and down, inwards or outwards to ensure that the charging device is arbitrarily aligned on the INS. FIG. 34 shows the user rotating the charging device 95 counterclockwise (left side) or clockwise (right side). 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, a marker, a flattened top). The target orientation can be rotated relative to a reference (e.g., a vertical or horizontal axis, or an incision of the INS embedding). The patient can feel the flattened top by hand when holding the charging device to achieve a specific rotational orientation, or the patient can place the charging device in the desired rotational orientation within the belt before wearing. Preferably, the belt is configured such that the patient can rotate the charging device while being fixed within the opening of the belt.

[0095] In an exemplary alignment procedure, the user moves the charging device during charging while observing the real-time variation of the charging efficiency level (e.g., as shown in FIG. 33). During this variation, the peak level is indicated by the application. When the charging efficiency is maintained near or at the peak level, the user maintains and records that position of the patient. This position may be recorded relative to the incision of the INS embedding. Optionally, the user then rotates the charging device, observes the variation of the charging efficiency, and determines the optimal rotation direction that provides the best charging efficiency. This rotation direction is also recorded. In some embodiments, by palpating the INS, a better understanding of the alignment of the charging device required before the procedure can be obtained and then confirmed with a dedicated application.

[0096] Once the optimal charging position has been determined by an expert, the expert is recommended to: 1) confirm that the position is reproducible with a mounting device (e.g., an adhesive device or a belt); 2) take photos, detailed records, and drawings of the ideal position; and 3) have the patient practice the ideal placement. In one aspect, this software-assisted procedure can be used during initial post-operative charging training to start the patient with the best charging device placement and charging experience. In another aspect, this procedure can also be used for troubleshooting patients who are experiencing sub-optimal charging. Even in patients in whom it has been shown that achieving optimal charging is difficult with this procedure, charging may still be occurring at levels 1 and 2. For such patients who cannot achieve charging at level 3 or higher, the expert can recommend charging more frequently or using lower treatment settings if possible to extend the battery life.

[0097] FIG. 35 shows an exemplary method for evaluating expert alignment used for initial training and / or troubleshooting of charging alignment. The method includes a step of establishing communication between a user device and an external charging device, where the charging device is configured to transcutaneously charge an implanted medical device, the user device is an external computing device associated with an expert and having a dedicated application for evaluating charging alignment, step 3501, charging the implanted medical device with the external charging device when at least a primary alignment is achieved, step 3502, receiving, with the user device, one or more charging parameters or associated charging metrics from the charging device during transcutaneous charging of the implanted medical device, step 3503, displaying, with the dedicated application, a real-time charging efficiency indicator on a display of the user device based on the one or more charging parameters or metrics, where the charging efficiency indicator corresponds to a fine-tuned alignment between the external charging device and the implanted medical device, step 3504; and moving the external charging device on a patient while the expert observes fluctuations of the charging efficiency indicator to determine an optimal position of the external charging device for charging, step 3505. In some embodiments, the dedicated application is configured to be used only by an expert. In some embodiments, the charging device may be a dedicated device configured to be used with an alignment application of an expert device and may further include additional charging functions for streamlining alignment optimization procedures.

[0098] In the foregoing specification, the subject matter has been described with reference to specific embodiments thereof, but one of ordinary skill in the art will recognize that the subject matter is not limited thereto. As used herein, the term "user device" can refer to a device of any of a patient, a clinician, or an expert associated with a device provider or manufacturer. The various features and aspects of the subject matter described above can be used individually or in combination. Further, the subject matter can be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of this specification. Accordingly, this specification and the drawings are to be regarded as illustrative rather than restrictive. The terms "comprising," "including," and "having" as used herein are particularly intended to be read as open-ended terms.

[0099] Appendix Appendix 1 A system for facilitating alignment between an external charging device and an implantable medical device within a patient, The system comprises 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, the external charging device including an antenna configured to communicate with one or more external devices and a processor configured to control charging at the charging coil and monitor one or more charging parameters during charging, the external charging device comprising one or more indicators configured to indicate a primary alignment of the external charging device with the implantable medical device and to enable charging upon detection of the primary alignment, The system comprises A portable user device, the 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 a memory storing a software application configured for at least one of the antenna, the user interface, and charging training and troubleshooting. The software application establishes communication with the external charging device, receives communication of one or more charging parameters or associated charging metrics during charging, and displays in real time a charging efficiency indicator based on the one or more charging parameters or the associated charging metrics corresponding to a fine-tuned alignment between the external charging device and the implantable medical device. including executable instructions configured to System.

[0100] (Appendix 2) The system according to Appendix 1, wherein the portable user device is configured for use by an expert who is at least one of a field technician, a representative, and a clinical care expert associated with a provider of the implantable medical device.

[0101] (Appendix 3) The system according to Appendix 1, wherein the software application includes a secure logon to ensure a secure connection between the portable user device and the external charging device.

[0102] (Appendix 4) The system according to Appendix 1, wherein the portable user device is a tablet device.

[0103] (Appendix 5) The system according to Appendix 1, wherein the external charging device is configured to communicate with the implantable medical device in a first type of communication and with the portable user device in a second type of communication.

[0104] (Appendix 6) The system according to Appendix 5, wherein the first type of communication is MedRadio and the second type of communication is Bluetooth.

[0105] (Appendix 7) The system according to Appendix 1, wherein the external charging device is a dedicated charging device configured to be used together with the software application.

[0106] (Appendix 8) The system according to Appendix 7, wherein the external charging device is configured to be used only by experts.

[0107] (Appendix 9) The system according to Appendix 7, wherein the external charging device includes an accelerated charging mode that operates with increased charging parameters compared to the standard charging mode of the patient's standard charging device.

[0108] (Appendix 10) The system according to Appendix 9, wherein the external charging device is configured to charge the implantable medical device in the accelerated charging mode until at least communication is established when the implantable medical device is in a resting state and / or has a low battery level.

[0109] (Appendix 11) The system according to Appendix 10, wherein the external charging device is further configured to charge the implantable medical device at the same speed as the standard charging mode after communication is established.

[0110] (Appendix 12) The system according to Appendix 1, wherein the software application is configured to display the charging efficiency indicator on a main display screen that further displays one or more additional indicators.

[0111] (Appendix 13) The system according to appendix 12, wherein the charging efficiency indicator is a bar extending between a plurality of different charging efficiency levels, and the bar is dynamically updated to display the current charging efficiency level in real time.

[0112] (Appendix 14) The system according to appendix 13, wherein the charging efficiency indicator further displays the peak level during the charging session.

[0113] (Appendix 15) The system according to appendix 14, wherein the one or more additional indicators include a charging efficiency history indicator.

[0114] (Appendix 16) The system according to appendix 14, wherein the one or more additional indicators further include the battery charge state.

[0115] (Appendix 17) The system according to appendix 14, wherein the one or more additional indicators further include the connection state.

[0116] (Appendix 18) The system according to appendix 14, wherein the one or more additional indicators further include a charging time indicator.

[0117] (Appendix 19) The system according to appendix 18, wherein the charging time indicator comprises one or both of an estimated remaining charging time and a total estimated charging time.

[0118] (Appendix 20) A method for arranging an external charging device for an implantable medical device, The method includes establishing communication between a processing device and the external charging device, the charging device being configured for transcutaneous charging of the implantable medical device, and the processing device having a software application for evaluating charging alignment, The method includes When at least primary alignment is achieved, charging the implantable medical device with the external charging device; Receiving, by the processing device, one or more charging parameters or associated charging metrics from the external charging device during transcutaneous charging of the implantable medical device; Displaying, by the software application, a real-time charge efficiency indicator based on the one or more charging parameters or metrics corresponding to a fine-tuned alignment between the external charging device and the implantable medical device on a display of a user device; Moving the external charging device on a patient in response to a change in the charge efficiency indicator displayed on the display to determine an optimal position of the external charging device for charging; A method comprising.

[0119] (Appendix 21) The method according to Appendix 20, wherein the step of moving the external charging device is performed by a field technician, representative, or clinical care specialist associated with a provider of the implantable medical device.

[0120] (Appendix 22) The method according to Appendix 20, wherein the software application is configured to be used only by an authenticated user.

[0121] (Appendix 23) The method according to Appendix 20, wherein the external charging device is configured to communicate with the implantable medical device using a first type of communication and with the processing device using a second type of communication.

[0122] (Appendix 24) The method according to Appendix 23, wherein the first type of communication is MedRadio and the second type of communication is Bluetooth.

[0123] (Appendix 25) The method according to appended claim 22, wherein the external charging device is a charging device configured to be used only together with the software application.

[0124] (Appended claim 26) The method according to appended claim 25, wherein when the implantable medical device is in a sleep mode and / or a mode with a low battery level, the external charging device is configured to charge the implantable medical device while operating in an accelerated charging mode as compared with a standard charging mode.

[0125] (Appended claim 27) The method according to appended claim 26, wherein when the implantable medical device is in a sleep state and / or a state with a low battery level, the external charging device is configured to charge the implantable medical device in the accelerated charging mode until at least communication is established.

[0126] (Appended claim 28) The method according to appended claim 27, wherein after communication is established, the external charging device is further configured to charge the implantable medical device at the same speed as the standard charging mode.

[0127] (Appended claim 29) The method according to appended claim 20, further comprising the step of displaying the charging efficiency indicator as a bar extending between a plurality of different charging efficiency levels and dynamically updating to display the current charging efficiency level in real time.

[0128] (Appended claim 30) The method according to appended claim 29, further comprising the step of displaying a peak level of charging efficiency during a charging session on the charging efficiency indicator.

[0129] (Appended claim 31) The method according to Appendix 30, further comprising the step of displaying one or more additional indicators on the display of the user device, wherein the one or more additional indicators include a charging efficiency history indicator, a battery charge state, a connection state, a charging time indicator, an estimated remaining charging time, a total estimated charging time, or any combination thereof.

[0130] (Appendix 32) A system for wireless charging of an implantable medical device, The system comprises An implantable medical device configured to be implanted in a patient, having a housing, the implantable medical device including 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. The system comprises An external charging device having a housing, the external charging device including 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, the receiving coil being configured to inductively receive energy from the charging coil, and at least a portion of the energy from the receiving coil being configured to be supplied to the energy storage device. The system comprises A portable user device configured to communicate with at least the external charging device and the implantable medical device, the portable user device including a user interface and a processor configured to execute a software application configured to assist in optimally positioning 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. System.

Claims

1. A system for facilitating alignment between an external charging device and an implantable medical device within a patient, the system comprising: an external charging device disposed within a housing and configured to magnetically couple with a corresponding receiving coil of the implantable medical device, the external charging device including an antenna configured to communicate with one or more external devices and a processor configured to control charging at the charging coil and monitor one or more charging parameters during charging, the external charging device comprising one or more indicators configured to indicate a primary alignment of the external charging device with the implantable medical device and enable charging upon detection of the primary alignment, the system further comprising: a portable user device having a housing, an antenna configured to communicate with at least one of the external charging device and the implantable medical device, a user interface, and a processor operably coupled to a memory storing a software application configured for at least one of charging training, troubleshooting, and the antenna and the user interface, the software application comprising: establishing communication with the external charging device, receiving communication of one or more charging parameters or associated charging metrics during charging, displaying in real time a charging efficiency indicator based on the one or more charging parameters or the associated charging metrics corresponding to a fine-tuned alignment between the external charging device and the implantable medical device, executable instructions configured as such, system.

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

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

4. The system of 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 in a first type of communication and communicate with the portable user device in 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 to be used together with the software application.

8. The system according to claim 7, wherein the external charging device is configured to be used only by experts.

9. The system according to claim 7, wherein the external charging device includes an accelerated charging mode that operates with increased charging parameters compared to the 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 until at least communication is established when the implantable medical device is in a resting state and / or has a low battery level.

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

12. The system according to claim 1, wherein the software application is configured to display the charging efficiency indicator on a main display screen that further displays one or more additional indicators.

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

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

15. The system according to claim 14, wherein the one or more additional indicators include a charging efficiency history indicator.

16. The system according to claim 14, wherein the one or more additional indicators further include a battery charge status.

17. The system according to 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 includes a charging time indicator. **Claim 19** The system of claim 18, wherein the charging time indicator comprises one or both of an estimated remaining charging time and a total estimated charging time. **Claim 20** A method for arranging an external charging device for an implantable medical device, wherein the method includes establishing communication between a processing device and the external charging device, the charging device being configured for transcutaneous charging of the implantable medical device, and the processing device having a software application for evaluating charging alignment, wherein the method when at least a primary alignment is achieved, charging the implantable medical device with the external charging device; receiving, by the processing device, one or more charging parameters or associated charging metrics from the external charging device during transcutaneous charging of the implantable medical device; displaying, by the software application, a real-time charging efficiency indicator based on the one or more charging parameters or metrics corresponding to a fine-tuned alignment between the external charging device and the implantable medical device on a display of a user device; moving the external charging device on a patient in response to a change in the charging efficiency indicator displayed on the display to determine an optimal position of the external charging device for charging; A method including the above steps. **Claim 21** The method of claim 20, wherein the step of moving the external charging device is performed by a field technician, representative, or clinical care specialist associated with a provider of the implantable medical device. **Claim 22** The method of claim 20, wherein the software application is configured to be used only by an authenticated user. **Claim 23** The method of claim 20, wherein the external charging device is configured to communicate with the implantable medical device in a first type of communication and with the processing device in a second type of communication. **Claim 24** The method of claim 23, wherein the first type of communication is MedRadio and the second type of communication is Bluetooth. **Claim 25** The method of claim 22, wherein the external charging device is a charging device configured to be used only in conjunction with the software application. **Claim 26** The method according to claim 25, wherein when the implantable medical device is in a sleep mode and / or a mode with a low battery level, the external charging device is configured to charge the implantable medical device while operating in an accelerated charging mode as 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 until at least communication is established when the implantable medical device is in a sleep state and / or a state with a low battery level.

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

29. The method according to claim 20, further comprising displaying the charging efficiency indicator as a bar extending between a plurality of different charging efficiency levels and dynamically updating to display the current charging efficiency level in real time.

30. The method according to claim 29, further comprising displaying a peak level of charging efficiency during a charging session on the charging efficiency indicator.

31. The method according to claim 30, further comprising displaying one or more additional indicators on a display of the user device, the one or more additional indicators including any of a charging efficiency history indicator, a battery charge state, a connection state, a charging time indicator, an estimated remaining charging time, a total estimated charging time, and any combination thereof.

32. A system for wireless charging of an implantable medical device, wherein the system comprises an implantable medical device configured to be implanted in a patient's body and having a housing, the implantable medical device including 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, the system comprises An external charging device having a housing, the external charging device including a charging coil disposed within the housing of the external charging device, the charging coil configured to magnetically couple with the receiving coil of the implantable medical device, the receiving coil configured to inductively receive energy from the charging coil, and at least a portion of the energy from the receiving coil configured to be supplied to the energy storage device. The system further comprises a portable user device configured to communicate with at least the external charging device and the implantable medical device, the portable user device including a user interface and a processor configured to execute a software application configured to assist in optimally positioning 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. System.

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