Systems and methods for providing alignment feedback and generating a recharge profile

Abstract

Systems and devices for providing alignment feedback are provided. A first device may include one or more signal generators and a second device may include one or more sensors. The second device may also include a feedback display for displaying alignment feedback based on signals received from the one or more signal generators by the one or more sensors.

Description

SYSTEMS AND METHODS FOR PROVIDING ALIGNMENT FEEDBACK ANDGENERATING A RECHARGE PROFILECROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 665,180 filed on June 27, 2024, entitled “SYSTEMS AND METHODS FOR PROVIDING ALIGNMENT FEEDBACK AND GENERATING A RECHARGE PROFILE”, the entirety of which is hereby incorporated herein by reference.BACKGROUND

[0002] The present disclosure is generally directed to aligning a first component and a second component, and relates more particularly to providing alignment feedback and generating a custom recharge profile.

[0003] Neuromodulation therapy may be carried out by sending an electric signal generated by a pulse generator to a stimulation target (e.g., nerves, non-neuronal cells, etc.), which may provide a stimulating or blocking therapy to the stimulation target. Such pulse generators are powered by one or more batteries that may be charged using a recharger.BRIEF SUMMARY

[0004] Systems and methods for providing alignment feedback are provided. Systems may include a first device having one or more signal generators configured to generate and transmit one or more signals. A second device may include one or more sensors configured to receive the one or more transmitted signals. The second device may also include an alignment feedback display for displaying feedback with respect to an alignment of the second device relative to the first device based on the one or more transmitted signals.

[0005] Example aspects of the present disclosure include:

[0006] A system for providing alignment feedback according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors and a feedback display configured to provide alignment feedback corresponding to a quality of an alignment of the one or more sensors relative to the one or more signal generators a processor; and a memory storing data for processing by the processor, thedata, when processed, causes the processor to: receive one or more sensor data from the one or more signal generators and the one or more sensors; process the one or more sensor data to determine an amplitude of the one or more sensors; determine the alignment feedback based on the processed one or more sensor data; and display the alignment feedback by the feedback display.

[0007] Any of the aspects herein, wherein the alignment feedback includes an alignment quality corresponding to whether the one or more sensors is aligned with the one or more signal generators.

[0008] Any of the aspects herein, wherein the alignment quality corresponds to alignment of one or more transducers of the one or more signal generators and one or more transducers of the one or more sensors when the one or more signal generators and the one or more sensors are within a proximal distance of each other that is below a proximal distance threshold and when the one or more sensors is oriented relative to the one or more signal generators at a target orientation.

[0009] Any of the aspects herein, wherein the alignment quality corresponds to misalignment of the one or more signal generators and the one or more sensors when at least one of the one or more signal generators and the one or more sensors are within the proximal distance of each other that is above the proximal distance threshold or when the one or more sensors is not oriented relative to the one or more signal generators at the target orientation.

[0010] Any of the aspects herein, wherein the alignment feedback includes an offset distance or an offset angle when the alignment quality corresponding to the misalignment.

[0011] Any of the aspects herein, wherein the first device is at least one of an implantable stimulator or a pump and the second device is at least one of a recharger or a refill device.

[0012] Any of the aspects herein, wherein the feedback display is integrated with a template of the refill device.

[0013] Any of the aspects herein, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

[0014] Any of the aspects herein, wherein the feedback display comprises a plurality of lights, each light positioned in proximity to a corresponding sensing coil, and wherein at least one light of the plurality of lights illuminates when the receiver coil is near the corresponding sensing coil.

[0015] A system for generating a recharge profile according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an upper limit and a lower limit of a recharge indicator based on the one or more patient inputs; and display the recharge indicator and a status of a recharge within the recharge indicator.

[0016] Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the upper limit and the lower limit based on the one or more updated patient inputs.

[0017] Any of the aspects herein, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0018] Any of the aspects herein, wherein the recharge indicator is displayed as a gauge with a dial that moves along the gauge between the upper limit and the lower limit.

[0019] Any of the aspects herein, wherein the upper limit corresponds to an optimal alignment between the first device and the second device, the lower limit corresponds to a suboptimal alignment between the first device and the second device, and the dial corresponds to an alignment quality.

[0020] Any of the aspects herein, wherein the alignment quality is determined from the one or more signal generators and the one or more sensors.

[0021] Any of the aspects herein, wherein the upper limit and the lower limit are based on a scaling factor determined from the one or more patient inputs.

[0022] Any of the aspects herein, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

[0023] A system for generating a recharge profile according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate the recharge profile based on the one or more patient inputs; recharge the first device using the second device for a time period; receive one or more recharger inputs during the time period; and generate a notification based on the one or more recharger inputs and the recharger profile.

[0024] Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

[0025] Any of the aspects herein, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0026] Any of the aspects herein, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

[0027] A system for generating a recharge profile according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate a recharge profile; generate a notification based on the recharge profile; receive one or more updated patient inputs; and update the recharge profile.

[0028] Any of the aspects herein, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0029] Any of the aspects herein, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

[0030] A system for generating a recharge profile according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an expiration interval based on the one or more patient inputs; and recharge the first device using the second device for a time period, wherein the expiration interval expires outside of the time period.

[0031] Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

[0032] Any of the aspects herein, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0033] Any of the aspects herein, wherein the expiration interval corresponds to a time interval that a security key between the first device and the second device will expire.

[0034] A system for providing alignment feedback according to at least one embodiment of the present disclosure comprises: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors and a feedback display configured to provide alignment feedback of the one or more sensors relative to the one or more signal generators, wherein one or more signals are received from the one or more signal generators by the one or more sensors, and wherein the one or more sensors provide alignment feedback based on the one or more signals.

[0035] Any of the aspects herein, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0036] Any of the aspects herein, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises one or more sense coils.

[0037] Any of the aspects herein, wherein the alignment feedback is displayed by one or more light displays, and wherein the one or more light displays activate based on sensor data received from the one or more sensors.

[0038] Any of the aspects herein, wherein the one or more light displays comprises one or more light emitting diodes (LEDs).

[0039] Any aspect in combination with any one or more other aspects.

[0040] Any one or more of the features disclosed herein.

[0041] Any one or more of the features as substantially disclosed herein.

[0042] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0043] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0044] Use of any one or more of the aspects or features as disclosed herein.

[0045] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0046] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0047] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xl-Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0048] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0049] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0050] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0051] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, moredetailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0052] Fig. l is a block diagram of a system according to at least one embodiment of the present disclosure;

[0053] Fig. 2 is a schematic diagram of a pump and refill system according to at least one embodiment of the present disclosure;

[0054] Fig. 3 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0055] Fig. 4 is a schematic diagram of a neuromodulation system according to at least one embodiment of the present disclosure;

[0056] Fig. 5 is a schematic diagram of a neuromodulation system according to at least one embodiment of the present disclosure;

[0057] Fig. 6 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0058] Fig. 7A is a schematic diagram of a feedback display according to at least one embodiment of the present disclosure;

[0059] Fig. 7B is a schematic diagram of a feedback display according to at least one embodiment of the present disclosure;

[0060] Fig. 7C is a schematic diagram of the feedback display of Fig. 7B according to at least one embodiment of the present disclosure;

[0061] Fig. 7D is a schematic diagram of a feedback display according to at least one embodiment of the present disclosure;

[0062] Fig. 8 is a flowchart according to at least one embodiment of the present disclosure;

[0063] Fig. 9 is a flowchart according to at least one embodiment of the present disclosure;

[0064] Fig. 10 is a chart according to at least one embodiment of the present disclosure;

[0065] Fig. 11 is a chart according to at least one embodiment of the present disclosure;

[0066] Fig. 12 is an image of an interface according to at least one embodiment of the present disclosure;

[0067] Fig. 13 is a flowchart according to at least one embodiment of the present disclosure;

[0068] Fig. 14 is a chart according to at least one embodiment of the present disclosure;

[0069] Fig. 15 is a chart according to at least one embodiment of the present disclosure;

[0070] Fig. 16 is an image of an interface according to at least one embodiment of the present disclosure;

[0071] Fig. 17 is an image of an interface according to at least one embodiment of the present disclosure;

[0072] Fig. 18 is a flowchart according to at least one embodiment of the present disclosure;

[0073] Fig. 19A is a graph according to at least one embodiment of the present disclosure;

[0074] Fig. 19B is a chart according to at least one embodiment of the present disclosure;

[0075] Fig. 20 is a state machine according to at least one embodiment of the present disclosure; and

[0076] Fig. 21 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0077] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device.

[0078] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0079] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0080] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0081] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to theregion of surgical interest in or on the patient, and further from the operator or user of the system.

[0082] For patients that use neuromodulation therapy devices such as, for example, an implantable stimulation device, the device may need periodic recharging by a recharger. This means that most patients hold a recharger like this one to their lower back for 30-60 minutes per day. It will be appreciated that in other instances, the patient may hold a recharger to any location of the patient for different neuromodulation therapies (e.g., spinal cord stimulation, deep brain stimulation, pelvic health (sacral and tibial nerve stimulation), etc.). For example, other therapies have different neurostimulator implant locations (e.g. chest, flank, ankle, abdomen) and different energy usage profiles which impacts the required frequency for recharge sessions and their durations. Despite this variance, a position of the recharger relative to the device is the most important factor for efficient power transfer. However, because the implant is in the body, its precise location is unknown to the patient, which may increase a difficulty of positioning the recharge relative to the device. Further, features common to other wireless recharge applications are not applicable (e.g. mechanical interlocks, magnetic alignment, or flat charging surface). Recharger positioning may be further impeded by the implant's location on the body (e.g. lower back) or a patient's limited motor control. Conventional methods for locating the recharger lack spatial precision and suffer from latency. For example, the recharger may beep when it is out of position, but it doesn't respond immediately to movement and it does not provide the patient feedback as to where it should be moved to.

[0083] Systems and methods according to at least one embodiment provide immediate feedback when misalignment of a second device (e.g., a recharger) and a first device (e.g., an implantable device) occurs and provides directional information to the patient. This directional feedback could be provided, for example, on a patient facing display as up / down left / right instructions. The system includes sense coils positioned circumferentially behind a primary recharge coil of the recharger. These sense coils (which can include, 4 sense coils, 8 sense coils, or any number of sense coils) respond directly to the current induced in the implantable device. In at least one embodiment, the sense coils are placed in a balanced position relative to the primary recharge coil so that there is negligible induced voltage on the sense coils when the implantable device is not present, or when the implant is perfectly centered. The sense coils may have a trapezoidal geometry. If the recharger drifts so that it is no longer centered over the implantable device, increased voltage will be induced on one or more of the sense coils. This increasedvoltage is read by an analog to digital converter on the recharger, and this information may be used to notify the patient to move the recharger back for an optimal experience. An alternating current (AC) signal could be read to measure magnitude and phase. Alternatively, a simpler and faster implementation could utilize rectified direct current (DC) signals for magnitude only.

[0084] The above systems and methods can be applied to other systems such as, for example, a therapeutic delivery system. In other embodiments, the first device can be an implanted pump and the second device can be a refill template used to help a user such as, for example, a medical provider, in locating the implanted pump. Currently alignment of refill templates consists of physical placement of a refill template using tactile feedback to align the external template to the implanted device. This involves guesswork to estimate where features of the pump are in relation to the template. To improve alignment, sensors can be positioned or integrated with the implanted device or within the external template (either reusable or disposable) that would provide a signal to the user when the template is aligned with the implanted device. In still other examples, the systems and methods may be used in, for example, targeted drug delivery.

[0085] For example, magnets may be placed at strategic locations on the implanted device and sensors within the template with a small battery and LED may light the LED when the template is in the target position relative to the implanted device. Alternatively, magnets could be at strategic locations on the external template with sensors within the pump. The key advantage of this approach is that a signal is communicated to the user indicating alignment of the template with the implanted device rather than relying upon the user’s tactile feedback, thereby improving the refill process.

[0086] The recharging experience for patients that use neuromodulation therapy devices as previously described is different for each patient and each patient has unique recharge patterns, approaches, implant depth, and lifestyle. Thus, customization of the recharge experience is desirable for patients.

[0087] Systems and methods for generating a custom recharge profile are provided. The systems and methods can be used for any type of neuromodulation therapy including, for example, spinal cord stimulation, deep brain stimulation, and / or pelvic health. The systems and methods receive patient input such as, for example, patient recharge patterns, patient demographics, recharge and implantable device information, etc. The patient input can be used to generate a custom recharge profile and notifications to the patient which may include, for example, time to refill (e.g., time to battery full or how long it takes to refillfrom present to a complete or finished recharge and / or time for next refill), time to empty, refill intervals, alignment quality feedback, etc. The custom recharge profiles may improve the patient’s recharge experience and reduce field representative time spent debugging and educating patients on recharge related concerns.

[0088] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) providing alignment feedback for aligning a first implantable device and a second external device, (2) providing directional feedback for aligning a first implantable device and a second external device, (3) reducing time spent recharging or refilling a first implantable device, (4) improving a patient’s recharging experience, and (5) provide custom notifications to a patient regarding recharging.

[0089] Turning first to Fig. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to determine and provide alignment feedback for two or more devices (e.g., an implantable device and recharger, an implantable device and refill kit; etc.), generate custom recharge profile(s) for an implantable device and recharger, and / or carry out one or more other aspects of one or more of the methods disclosed herein. The system 100 comprises a computing device 102, a first device 112, a second device 116, a database 130, and / or a cloud or other network 134. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include one or more components of the computing device 102, the database 130, and / or the cloud 134.

[0090] The computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102. It will be appreciated that in some embodiments, the computing device 102 may be a handheld device such as, for example, a mobile smart phone and / or a tablet.

[0091] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions stored in the memory 106, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the first device 112, the second device 116, the database 130, and / or the cloud 134.

[0092] The memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory forstoring computer-readable data and / or instructions. The memory 106 may store information or data useful for completing, for example, any step of the methods 800, 900, 1300, and / or 1800 described herein, or of any other methods. The memory 106 may store, for example, instructions and / or machine learning models. For instance, the memory 106 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 104, enable sensor processing 120, recharge profile generation 122, and / or alignment feedback generation 124.

[0093] The sensor processing 120 enables the processor 104 (or a processor 126 of the second device 116) to process sensor data from one or more sensor(s) 118 of the second device 116 for the purpose of, for example, obtaining a magnitude for at least one sensor 118 of the sensor(s) 118, as will be discussed in more detail in Figs. 2-9. The magnitude may be used by the alignment feedback generation 122 to provide feedback regarding an alignment of the second device 116 relative to the first device 112.

[0094] The alignment feedback generation 122 enables the processor 104, 126 to receive the processed sensor data from, for example, the sensor processing 120 for the purpose of providing feedback regarding the alignment of the second device 116. In some embodiments, the alignment feedback may be communicated to a user through a light display, a display on a handheld device, audible feedback, or the like, as will be discussed in detail in Figs. 2-9.

[0095] The recharge profile generation 124 enables the processor 104, 126 to generate a custom recharger profile for a patient. The recharge profile generation 124 may receive patient input such as, for example, a patient’s typical recharge patterns and / or parameters, abnormal recharge patterns and / or parameters, a map of an implantable device on the patient, implantable device and recharger device information, patient preference on notification type (e.g., beeping volume, brightness of notification, color settings, vibration settings, audible settings, etc.) to generate the recharger profile, as will be discussed in detail in Figs. 10-18.

[0096] Such content, if provided as instructions, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. Thus, although various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achievedthrough use of instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate data stored in the memory 106 and / or received from or via the first device 112, the second device 116, the database 130, and / or the cloud 134.

[0097] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving image data or other information from an external source (such as the first device 112, the second device 116, the database 130, the cloud 134, and / or any other system or component not part of the system 100), and / or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the first device 112, the second device 116, the database 130, the cloud 134, and / or any other system or component not part of the system 100). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive information via one or more wireless communication protocols such as 802.1 la / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0098] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a user such as a medical provider or a patient to adjust one or more parameters of a neuromodulation therapy system 400 and / or a therapeutic delivery system 200, and / or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.

[0099] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that ishoused separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computer device 102.

[0100] The first device 112 may be an implantable device such as, for example, an implantable device such as the therapeutic delivery system 200 (shown in Figs. 2-3) and / or the neuromodulation system 400 (shown in Figs. 4-6). It will be appreciated that in some embodiments, the first device 112 may not be implanted in a patient. The first device 112 may include the signal generators 114. In some embodiments, the signal generators 114 may be, for example, a receiver coil, a hall effect sensor or magnet, infrared or visible light transmitters or receivers, ultrasound transmitters or receivers, haptic sensors or transmitters, pressure sensors, temperature sensors, copper plates or temperature sensor, accelerometers, and / or any other proximity sensor. The second device 116 may be a device external to the first device 112 such as, for example, a syringe of a refill kit 230 of the therapeutic delivery system 200 or a recharger 430 of the neuromodulation system 400. The second device 116 may include the sensors 118. In some embodiments, the sensors 118 may be, for example, a sense coil, a hall effect sensor or magnet, any other proximity sensor infrared or visible light transmitters or receivers, ultrasound transmitters or receivers, haptic sensors or transmitters, pressure sensors, temperature sensors, copper plates or temperature sensor, and / or accelerometers. The signal generators 114 may be used with the sensors 118 to determine alignment between the first device 112 and the second device 116.

[0101] The second device 116 may also include a processor 126, which may be the same as or similar to the processor 104, and a memory 128, which may be the same as or similar to the memory 106. The second device 116 may further include a feedback display 136 configured to provide feedback to a user regarding an alignment of the second device 116 relative to the first device 112, which will be described in more detail in Figs. 2-18. It will be appreciated that the second device 116 may not include the processor 126, the memory 128, and / or the feedback display 136. Further although the feedback display 136 is shown as part of the second device 116, in some embodiments, the second device may utilize a feedback display 136 that is housed separately from one or more remaining components of the second device 116. In some embodiments, the feedback display 136 may be located proximate one or more other components of the second device 116, while in otherembodiments, the feedback display 136 may be located remotely from one or more other components of the second device 116.

[0102] In some embodiments, the second device 116 may communicate with the computing device 102 (which may be, for example, a handheld device such as a mobile phone or a tablet) to provide feedback to a user. For example, the second device 116 may communicate with the computing device 102 to display information about a refill or a recharge such as time to complete the refill or the recharge on, for example, the user interface 110. The second device 116 may communicate with the computing device 102 wireless or wired. It will also be appreciated that in some embodiments, the system 100 may not include the computing device 102. In other words, the first device 112 and the second device 116 may work without the computing device 102.

[0103] The database 130 may store information about the patient such as a patient’s typical recharge patterns and / or parameters, abnormal recharge patterns and / or parameters, a map of an implantable device on the patient, implantable device and recharger device information, patient preference on notification type (e.g., beeping volume, brightness of notification, color settings, vibration settings, audible settings, etc.). The database 130 may additionally or alternatively store, for example, one or more patient recharge profiles. The database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records including image data.

[0104] The cloud 134 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 may communicate with the database 130 and / or an external device (e.g., a computing device) via the cloud 134.

[0105] The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the methods 800, 900, 1300, and / or 1800 described herein. The system 100 or similar systems may also be used for other purposes.

[0106] Turning to Figs. 2 and 3, a schematic diagram of the therapeutic delivery system 200 and a block diagram of the therapeutic delivery system 200 are respectively shown. In such embodiments, the first device 112 may comprise the therapeutic delivery system 200,as mentioned above and as described in detail below, and the second device 116 may comprise a refill kit 230.

[0107] As shown, the therapeutic delivery system 200 is implanted in a patient. The therapeutic delivery system 200 comprises a catheter 206 and a pump 214 having a port 204 and a septum 226. The septum 226 may be in fluid communication with the catheter 206. In the illustrated embodiment, the pump 214 is implanted subcutaneously 210 under a surface 208 of the patient’s skin. In other embodiments, the pump 214 may be implanted anywhere on the patient and may be implanted at the surface 208. The pump 214 may be in fluid communication with the catheter 206 via the port 204. The therapeutics can be stored in the therapeutic delivery system 200 and delivered to the patient via the pump 214 pumping the therapeutics to the patient through the catheter 206. However, because the therapeutic delivery system 200 can only hold a fixed quantity of therapeutics, the pump 214 is routinely refilled using a second device 116 such as the refill kit 230.

[0108] The refill kit 230 includes a needle 212 configured to access the port 204, a reservoir 216 containing the therapeutics, and / or a template 232 (which may be reusable or one time use). During a refill process, the template 232 is placed over the patient at the pump’s 214 estimated location. The needle 212 is then used to pierce the patient’s skin and the septum 226 until the needle 212 contacts a needle stop in the port 204 beneath the septum 226. Once the needle 212 has reached the stop, the needle 212 is in fluid communication with the port 204 to deliver therapeutics to the therapeutic delivery system 200 from the reservoir 216.

[0109] The therapeutic delivery system 200 and the refill kit 230 also include the signal generator(s) 114 and the sensor 118, respectively, to aid in alignment of the needle 212 to the port 204. As previously described, conventionally, a user such as, for example, a health care provider (HCP) would tactically locate the implanted pump 214 in the patient and place the template 232 over the patient at the approximate location of the pump 214. However, such placement is an estimate, and may not accurately reflect the location of the pump 214. Thus, the signal generator(s) 114 may be located on or integrated with the pump 214 and the sensor(s) 118 may be located on or integrated with any component of the refill kit 230.

[0110] More specifically, the sensor(s) 118 may be located on or integrated with, for example, the template 232. In some embodiments, the signal generator 114 and the sensor 118 may comprise at least one magnet and at least one hall sensor. In such embodiments, the at least one magnet may be located on or integrated with the pump 214 or the template232 and the at least one hall sensor may be located on or integrated with the pump 214 or the template 232. The at least one magnet and the at least one hall sensor may be used to determine when the template 232 is within a desired proximity or position of the pump 214 when the at least one magnet is within the desired proximity or position of the at least one Hall sensor to induce a measurable Hall voltage. The Hall voltage can be processed by, for example, the processor 126 of the second device 116 (e.g., the template 232 or any other component of the refill kit 230) or the processor 104 of the computing device 102 using the sensor processing 120 to determine a magnitude of the Hall voltage. The Hall voltage can then be processed by the alignment feedback generation 122 to determine whether the measurable Hall voltage is within a predetermined threshold corresponding to a desired placement of the template 232 relative to the pump 214. It will be appreciated that in other embodiments, the signal generator 114 and / or the sensor 118 may be any sensor configured to sense proximity of the first device 112 relative to the second device 116. It will also be appreciated that any number of signal generator 114 and / or sensors 118 may be used. For example, two or more signal generators 114 and / or sensors may be used to aid in providing feedback about an orientation of the second device 116 (e.g., the template 232) relative to the first device 112 (e.g., the pump 214).

[0111] Alignment feedback of the template 232 relative to the pump 214 (via the signal generator 114 and the sensor 118) may be communicated via the feedback display 136 of the second device 116 and / or the user interface 110 of the computing device 102. In some embodiments, the feedback display 136 includes an LED on the template 232 that may activate when the template 232 is in the desired position relative to the pump 214. In other embodiments, the feedback display 136 may provide any visual feedback, audible feedback, and / or tactile feedback to indicate alignment of the template 232 relative to the pump 214. Additionally or alternatively, the user interface 110 may include a graphical display with information such as, for example, refill remaining time, status of the refill, etc.

[0112] Though the signal generator 114 and the sensor 118 are used to aid in alignment of the refill kit 230 (via, for example, the template 232) and the therapeutic delivery system 200 (via, for example, the pump 214), the signal generator 114 and the sensor 118 can be used to aid in the alignment of any first device 112 and second device 116 such as, for example, an implantable device 402 of the neuromodulation system 400 and a recharger 430 as will be described below.

[0113] Turning to Figs. 4-7B, diagrams of aspects of a neurostimulation system 400 (the system 400) according to at least one embodiment of the present disclosure are shown. The system 400 may be used to provide electric signals to a patient and / or carry out one or more other aspects of one or more of the methods disclosed herein. As previously described, the first device 112 may comprise the device 402 and the second device 116 may comprise the recharger 430, as will be described in more detail below.

[0114] The system 400 may include at least a device 402 (which may be used for, for example, a close-loop or open spinal cord stimulation, deep brain stimulation, pelvic health, etc.) that is capable of providing a stimulation to a target anatomical element. In the illustrated embodiment, the target anatomical element is a spinal cord 408 of the patient, though in other embodiments the target anatomical element may be, for example, a brain of the patient and / or one or more nerve endings of the patient. In some examples, the device 402 may be referred to as a close-loop stimulator, an open-loop stimulator, a pulse generator, an implantable neural stimulator, an internal neural stimulator, or the like, which may be implantable in some embodiments. More specifically, the device 402 may be configured to generate a current or electrical signal that is delivered to the target anatomical element. Additionally, the system 400 may include one or more leads 404 (e.g., electrical leads) that provide a connection between the device 402 and the spinal cord or nerves of the patient for enabling, for example, stimulation. In some embodiments, the leads 404 may be implanted wholly or partially within the patient. The leads 404 may be, for example, paddle leads and / or percutaneous leads.

[0115] Neuromodulation or neurostimulation techniques (e.g., technologies that act directly upon nerves of a patient, such as the alteration, or “modulation,” of nerve activity by delivering electrical impulses directly to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments (e.g., chronic pain) of a patient. As discussed herein, neuromodulation techniques may be used to relieve chronic pain. Additionally or alternatively, neuromodulation techniques may be used to stimulate or prevent other neurological signals from traveling to or from the patient’s brain for the purposes of assisting with patient treatment. In some embodiments, the device 402 may provide electrical stimulation of the target anatomical element of the patient (or one or more nerves therein) to relieve chronic pain.

[0116] In some embodiments, the one or more leads 404 may include a first lead 404A that is implanted in a position to provide therapy to a first side of the spinal cord 408 of the patient and a second lead 404B implanted to provide therapy to a second side of thespinal cord 408 of the patient. It will be appreciated that in other embodiments, the one or more leads 404 may include at least the first lead 404A and the second lead 404B connected to any anatomical element such as, for example, respective vagal trunks (e.g., different trunks of the vagus nerve) or to other respective nerves in a patient. For example, the first lead 404 A may be connected to a first vagal trunk of the patient (e.g., the anterior sub diaphragmatic vagal trunk at the hepatic branching point of the vagus nerve) and the second lead 404B may be connected to a second vagal trunk of the patient (e.g., the posterior sub diaphragmatic vagal trunk at the celiac branching point of the vagus nerve). The first lead 404A and / or the second lead 404B may be configured to provide an electrical stimulation signal from the device 402 to the respective first and / or second vagal trunk. The connection of the leads 404 to the respective vagal trunk (or other nerves) of the patient may permit the device 402 to measure and / or provide one or more stimulations in the patient based on the provided electrical stimulation from the device 402.

[0117] Fig. 5 depicts the device 402 and the leads 404 connected to the spinal cord 408 of the patient, the leads 404 including one or more electrodes 408, 410 that receive a current or other stimulant instructions from the device 402 (e.g., via the leads 404). In some examples, the electrodes 408, 410 may each include a body and a plurality of electrodes 408A-408D, 410A-410D that are disposed on respective first and second sides 404 A, 404B of the spinal cord 408, where the plurality of electrodes 408A-408D, 410A- 410D are configured to apply the current generated by the device 402 to the spinal cord 408. It will be appreciated that in other embodiments or examples, the leads 404 may include any number of electrodes. As shown, a first electrode 408 may be configured for placement on the spinal cord 408 to apply a current to the spinal cord 408 (e.g., carried via a first lead 404A and emitted from one or more of the electrodes 408A-408D), and a second electrode 410 may also be configured for placement on the spinal cord 408 to apply a current to the spinal cord (e.g., carried via a second lead 404B and emitted from one or more of the electrodes 410A-410D). In some examples, the electrodes 408, 410 may be referred to as cuff electrodes.

[0118] As shown in Fig. 6, the device 402 may include a battery 432 so as to power the device 402, which may be recharged by a receiver coil 434 and a recharger 430. The recharger 430 may include one or more coils 436. The one or more coils 436 may include a recharge or transmitter coil 436 A and one or more sense coils 436B. In some embodiments, the recharge coil 436A and the one or more sense coils 436B may be thesame coils. In other embodiments, the recharge coil 436A and the one or more sense coils 436B may be different coils.

[0119] The recharge coil 436A may be configured to charge the receiver coil 434 when the recharge coil 436A is held in proximity to the receiver coil 434. The position and orientation of the recharge coil 436A relative to the receiver coil 434 may impact the quality of the charge and misalignment of the recharge coil 436A relative to the receiver coil 434 may lead to an increase in time to charge the receiver coil 434 and the battery 432. Conventional methods to alert a user (such as a patient) as to a target alignment between the recharger 430 and the device 402 such as, for example, simply beeping when the device 402 and the recharger 430 are misaligned are inadequate as the patient does not know which way to move the recharger 430. Thus, the one or more sense coils 436B may be used to determine both a relative position between the device 402 and the recharger 430 and provide alignment feedback to the patient such as a direction in which to move the recharger 430.

[0120] In such embodiments, the receiver coil 434 may correspond to the signal generator 114 and the one or more sense coils 436B may correspond to the sensor 118. The sense coils 436B may be evenly spaced and positioned circumferentially behind the recharge coil 436 A and configured to respond directly to current induced in the receiver coil 434. In such embodiments, the sense coils 436B may include between three and eight sense coils positioned in a balanced position relative to the recharge coil 436A such that there is no induced voltage on the sense coils 436B when the receiver coil 434 is not present or is centered within the sense coils 436B. The sense coils 436B may also have a trapezoidal geometry. It will be appreciated that in other embodiments, the sense coils 436B may include one sense coil, two sense coils, or more than two sense coils. In some embodiments, a flux concentrator (ferrite) may be present behind the sense coils 436B.

[0121] If the receiver coil 434 is positioned closer to at least one of the sense coils 436B, such sense coil(s) 436B will have a greater amp reading and the remaining sense coil(s) 436B will have a corresponding lower amp reading. Thus, in at least one embodiment, a reading of the amps may provide directional information where the sense coil(s) 436B with a greater amp reading indicates that the recharger 430 is close to those sense coil(s) 436B. Thus, the directional information (generated by, for example, the alignment feedback generation 122) can be used to communicate to the patient to move the recharger 430 away from the sense coil(s) 436B with the greater amp reading. In other embodiments, the sensor data from the sense coils 436B can be scanned by, for example,an analog to digital converter to determine misalignment direction. An AC signal can be read and processed (using, for example, the sensor processing 120) from the sense coils 436B to measure a magnitude and phase for the sense coils 436B. Alternatively, a rectified DC signals may be obtained for magnitude only. The magnitude and / or phase information may be used as input by, for example, the alignment feedback generation 122.

[0122] The directional information may be communicated to the patient as alignment feedback via the feedback display 136 and / or the user interface 110 of the computing device 102. In some embodiments, as illustrated in Fig. 7A, the feedback display 136 may include a plurality of LEDs 440 and each LED corresponds to a sense coil 436B. When the receiver coil 434 is positioned closer to one of the sense coils 436B, the corresponding LED 440 may illuminate red while the other LEDs 440 may illuminate green to indicate that the receiver coil 434 should be moved away from the LED 440 that is red. It will be appreciated that the LEDs 440 may illuminate any color. When the receiver coil 434 is centered on the recharger coil 436 A, all of the plurality of LEDs 440 may illuminate green, or may not illuminate at all. Thus, the plurality of LEDs 440 may provide directional information to the patient such that the patient can move the recharger 430 to a target alignment. Directional information may also be provided to the patient. Directional information may include, for example, directions to move the recharger 430 (or any second device 116) to the left, the right, up, down, or any direction. In some embodiments, directional information may be provided in the form of, for example, a plurality of arrows 702 as shown in Figs. 7B and 7C. In such embodiments, an arrow 702 may illuminate to indicate which direction the second device 116 (e.g., the recharger 430) should be moved, as shown in Fig. 7C. It will be appreciated that directional information may be provided in any form (e.g., the LED lights, text instructions, audible instructions, directional arrows, etc.).

[0123] In some embodiments, the feedback display 136 may be displayed on a patient 700 as shown in Fig. 7D. In such embodiments, the feedback display 136 may be projected onto the patient. The feedback display 136 may be displayed so as to align the feedback display 136 with, for example, the device 402.

[0124] In other embodiments, the feedback display 136 may provide any visual feedback, audible feedback, and / or tactile feedback to indicate alignment of the recharge coil 436A relative to the receiver coil 434. Additionally or alternatively, the user interface 110 may include a graphical display to indicate a quality of the alignment, a time to complete recharge, next recharge time, etc. as will be discussed in Figs. 12 and 16-17.

[0125] Figs. 19A-21 will be described together. Fig. 19A depicts a graph 1900 illustrating a representation of a recharger including three coils 436. The three coils 436 can be transmit and sense coils for example that are both 436A and 436B and various locations an implanted device may be at relative to the recharger and Fig. 19B depicts a chart 1950 illustrating configuration information for the representation of the recharger and the various locations relative to the recharger illustrated in Fig. 19A. Fig. 20 depicts a state machine 2000 for providing alignment feedback and Fig. 21 depicts a method 2100 that may be used, for example, for providing alignment feedback for a first device such as first device 112 and a second device such as the second device 116.

[0126] As illustrated in Fig. 19 A, graph 1900 includes a representation of the recharger 430 (“recharger representation 1916”), a representation of a coil 436B (“coil A representation 1904”), a representation of a coil 436B (“coil B representation 1908”) a representation of a coil 436B (“coil C representation 1912”) and location numbers (e.g., location numbers 1-12) provided at locations near or intersecting with recharger representation 1916. Each of the location numbers 1-12 is encircled. Coil A representation 1904, coil B representation 1908 and coil C representation 1912 may be arranged in a slightly overlapping manner and / or may be arranged edge to edge. The X-axis and Y-axis of the graph 1900 each represents a distance metric, with numerical values provided without specified units used to identify a location for recharger representation 1916, coil A representation 1904, coil B representation 1908, coil C representation 1912 and the location numbers 1-12. Although representations for the three coils are illustrated, the coils can include 4 coils, 8 coils, or any number of coils. Moreover, although the representations for the coils have a circular shape, other shapes can be used for the coils without departing from the spirit and scope of the present disclosure.

[0127] As illustrated in Fig. 19B, chart 1950 includes 6 columns and 13 rows. The columns are identified as follows: column 1 identifies the location number; column 2 identifies the x-coordinate for a location number, column 3 identifies the y-coordinate for the location number; column 4 identifies if coil A is activated (identified by a “+”) or not activated (identified by a “0”) based on the position of the location number, column 5 identifies if coil B is activated (identified by a “+”) or not activated (identified by a “0”) based on the position of the location number, and column 6 identifies if coil C is activated (identified by a “+”) or not activated (identified by a “0”) based on the position of the location number. The “+” is indicative of a phase of 0 degrees which for simplicity in this example is for all the positions as this example assumes that the coils in the first device112 and the second device 116 are coplanar. In other examples, not listed, the coils may be transmitting and sensing out of phase with one another, such as perfectly out of phase which may be indicated with a symbol. The rows are identified as follows: row 1 identifies the heading name for each of the columns identified above; row 2 is configuration information for location number 1; row 3 is configuration information for location number 2; row 4 is configuration information for location number 3; row 5 is configuration information for location number 4; row 6 is configuration information for location number 5; row 7 is configuration information for location number 6; row 8 is configuration information for location number 7; row 9 is configuration information for location number 8; row 10 is configuration information for location number 9; row 11 is configuration information for location number 10; row 12 is configuration information for location number 11; and row 13 is configuration information for location number 12.

[0128] For example, when the implant is at location 1 it is positioned at coordinates (INSX=5, INY=5) on the graph 1900. At this position, location 1 is near each of coil A, coil B and coil C and coil A, coil B and coil C are activated. This is because recharge will be most effective at position 1 when all three coils are activated in phase with each other, when the implant is centered on the three coils A, B, C. Location 2 is positioned at coordinates (5, 7.5) which is located at a central position within coil A. Therefore, only coil A is activated in order to recharge most effectively. Additionally, the system can say that the position of the implant is at approximately 7.5 in Y and 5 in X at this position on a user interface. Location 3 is positioned at coordinates (3, 3) coil B which is located at a central position within coil B. Therefore, only coil B is activated. Location 4 is positioned at coordinates (7, 3) which is located at a central position within coil C. Therefore, only coil C is activated. Location 5 is positioned at coordinates (7.5, 7) which is provided near coil A and coil C. Therefore, coil A and coil C are activated. Location 6 is positioned at coordinates (2, 6) and is provided near coil A and coil B. Therefore, coil A and coil B are activated. Location 7 is positioned at coordinates (5, 2) and is provided near coil B and coil C. Therefore, coil B and coil C are activated. Location 8 is positioned at coordinates (9, 2) and provided only near coil C. Therefore, only coil C is activated. Location 9 is positioned at coordinates (5, 10) and is provided only near coil A. Therefore, only coil A is activated. Location 10 is positioned at coordinates (1, 2) and is provided only near coil B. Therefore, only coil B is activated. Location 11 is positioned at coordinates (9, 7) and is provided near coil A and coil C. Therefore, coil A and coil C are activated. Location 12is positioned at coordinates (1, 7) and is provided near coil A and coil B. Therefore, coil A and coil B are activated.

[0129] According to an embodiment of the present disclosure, each of the location numbers 1-12 may represent a location of the device 402 as illustrated in Figs. 4-6. Therefore, depending on where the device 402 is located relative to the recharger 430, the recharger 430 would automatically activate the correct coil(s) 436B. Location 1 is the only location where all three coils are activated. In general, there are only two coils activated at one time for each of the other locations (e.g., locations 2-12).

[0130] Fig. 19B provides an example of the device 402 in phase at each of the locations 1-12. According to an alternative embodiment of the present disclosure, one or more of the locations 1-12 of the device 402 may be rotated 90 degrees around the y-axis for example. Therefore, the field lines would go in the xy-direction as opposed to in the z- direction for the one or more of the locations 1-12 with the device 402 rotated by 90 degrees. For example, at position 6 where x = 2 and y = 6, if the device 402 is rotated 90 degrees and the long dimension of the device is aligned with positions 6 and 1 (not shown), the optimal combination of coils to activate may be A and B out of phase, so A = “+” and B = so that the energy transmitted results in field lines that are directed parallel with a line between positions 2 and 3 or between positions 9 and 10. In this way, a rotated device no longer parallel with the skin could still be effectively recharged. Such combinations are not listed in Fig. 19B but those skilled in the art will understand that different coils could be activated out of phase with one another to change the directionality of the magnetic field lines emitted by the recharger in order to enhance the charging of the implanted device.

[0131] Fig. 20 depicts a state machine 2000 for providing alignment feedback. State machine 2000 includes a start state 2004, a searching state 2008, an optimizing state 2012, a stable and charging state 2016, a charging complete state 2020 and an end or done state 2024. According to one example of the present disclosure, a user may be charging the device 402 which is provided at location 3 with the recharger 430. The user makes a movement that adjusts the position of the recharger 430 such that the user has lost coupling with the device 402. Referring to Fig. 19B, with device 402 provided at location 3, only coil B is being activated. Since the user has lost coupling with the recharger 430 at location 3 because of the user’s movement, the recharger 430 is now at location 5 where coil C is deactivated. In this case, the recharger 430 goes into a searching state as exemplified at searching state 2008 illustrated in Fig. 20. At searching state 2008, therecharger 430 goes through each coil to determine if charge current is detected. From the example above, recharger 430 detects that there is some charge current at coils A and C, but not at coil B as illustrated in Fig. 19A with the coils A and C being located close to location 5, but coil B being located away from location 5. After it is estimated that coils A and C are being used (found), the recharger 430 enters the optimizing state 2012. At the optimizing state 2012, the recharger 430 can be further optimized and go into the stable and charging state 2016. In the optimizing state 2012, if the two coils operating in phase are not effective, then different phases such as A “+” and Cwould be attempted. The optimizing state may include a sweep of the two coils phase alignment from 0 to 45 to 90 to 135 to 180 degrees, as one non-limiting example, or it may only sweep between 0 to 90 to 180 degrees or any other combination of phase sweeps of the two coils. The recharger 430 remains in the stable and charging state 2016 until coupling has changed and the recharger 430 returns to the optimizing state 2012 or the device 402 receives a complete or full charge and the recharger 430 enters into the charging complete state 2020 and the process ends or is done at state 2024.

[0132] Fig. 21 depicts a method 2100 that may be used, for example, for providing alignment feedback for a first device such as the first device 112 and a second device such as the second device 116.

[0133] The method 2100 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 and / or the processor 126 of the second device 116 described above. A processor other than any processor described herein may also be used to execute the method 2100. The at least one processor may perform the method 2100 by executing elements stored in a memory such as the memory 106, 128. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 2100. One or more portions of a method 2100 may be performed by the processor executing any of the contents of memory, such a sensor processing 120, and / or an alignment feedback generation 122.

[0134] Generally, method 2100 starts with a START operation at step 2104 and ends with an END operation at step 2152. As illustrated in Fig 21, method 2100 starts with the START operation at step 2104 and proceeds to step 2108, where the recharger 430 searches all of the coils (e.g., coil A, coil B and coil C). After searching all of the coils at step 2108, method 2100 proceeds to step 2112, where the recharger 430 searches(transmits energy using) single coil A. After searching single coil A at step 2112, method 2100 proceeds to step 2116, where the recharger 430 searches single coil B. After searching single coil B at step 2116, method 2100 proceeds to step 2120, where the recharger 430 searches single coil C. Although not illustrated, recharger 430 may search one or more combinations of coils. After searching single coil C at step 2120, method 2100 proceeds to step 2124, where the position of the device 402 is estimated based on the previously mentioned search results. After the position of the device 402 is estimated at step 2124, method 2100 proceeds to step 2128 where the recharger 430 tries a new single or dual coil recharge. For example, if the position was estimated to be between coil A and coil B then both coil A and coil B will be activated in phase or coil B and coil C will be activated in phase, etc. in step 2128. After the recharger 430 tries a new single or dual coil recharge at step 2128, method 2100 proceeds to decision step 2132, where the recharger 430 determines if there is success in locating the device 402. If there is success in locating the device 402 (YES) at decision step 2132, method 2100 proceeds to step 2136 where the recharger 430 performs stable charging on the device 402. If there is no success in locating the device 402 (NO) at decision step 2132, method 2100 proceeds to step 2140 where the recharger 430 sweeps phase in case device 402 is tilted. As described previously two coils may be swept from 0 to 180, 0 to 90 to 180, 0 to 45 to 90 to 135 to 180 to 225 to 270 to 315 back to 0. In this way, if the device 402 is not parallel with coils A, B, and C, then the out of phase search may find a phase where recharge is successful. After the recharger 430 sweeps phase in case device 402 is tilted at step 2140, method 2100 proceeds to decision step 2144 where the recharger 430 determines if the count has been exceeded. If the count has been exceeded (YES) at decision step 2144, method 2100 proceeds to step 2148 where the recharger 430 is moved and the user is informed. After the recharger 430 is moved and the user is informed, method 2100 returns to step 2108, where the recharger 430 searches all of the coils (e.g., coil A, coil B and coil C). If the count has not exceeded (NO) at decision step 2144, method 2100 returns to decision step 2132 where the recharger 430 determines if there is success in locating the device 402. After the recharger 430 performs stable charging on the device 402 at step 2136, method 2100 ends at the END operation at step 2152. Steps 2108, 2112, 2116, 2120, and 2124 may encompass state 2008 and steps 2128, 2132, 2140 may encompass state 2012. One skilled in the art could also envision that states 2008 and 2012 could be combined and method 2100 (minus 2104, 2136, and 2152) could be continuously run in this combined state.

[0135] The system 400 or similar systems may be used, for example, to carry out one or more aspects of the methods 800, 900, 1300, and 1800 described herein. The system 400 or similar systems may also be used for other purposes. It will be appreciated that the human body has many nerves and the stimulation and / or measurement described herein may be applied to one or more nerves, which may reside at any location of a patient (e.g., lumbar, thoracic, etc.). Further, the use of the leads 404 to stimulate a target anatomical element may occur with different portions of the nervous system. For example, the leads 404 may be connected to one or more of nerve endings in the spinal cord, the brain or portions thereof, combinations thereof, and the like.

[0136] Fig. 8 depicts a method 800 that may be used, for example, for providing alignment feedback for a first device such as the first device 112 and a second device such as the second device 116.

[0137] The method 800 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 and / or the processor 126 of the second device 116 described above. A processor other than any processor described herein may also be used to execute the method 800. The at least one processor may perform the method 800 by executing elements stored in a memory such as the memory 106, 128. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 800. One or more portions of a method 800 may be performed by the processor executing any of the contents of memory, such a sensor processing 120, an alignment feedback generation 122, and / or a recharge profile model generation 124.

[0138] The method 800 comprises receiving sensor data and / or one or more signals from a signal generator and / or a sensor (step 804). The signal generator may be the same as or similar to the signal generator 114 of a first device such as the first device 112 and the sensor may be the same as or similar to the sensor 118 of a second device such as the second device 116. As previously described, the first device may be, for example, a therapeutic delivery system such as the therapeutic delivery system 200 or an implantable device such as the device 402 of a neuromodulation therapy system such as the neuromodulation therapy system 400 and the second device may be, for example, a refill kit such as the refill kit 230 or a recharger such as the recharger 430. The first device may be implanted in a patient and the second device may be external to the patient. The second device may be used, for example, to refill or recharge the first device. However, becausethe second device is external to the first device and the first device may be implanted at different depths and / or orientations for different patients, positioning the second device relative to the first device at an optimal or targe relative position may be difficult to achieve. Thus, the signal generator and the sensor may be used to determine a relative position between the first device and the second device and to provide alignment feedback based on the relative position. The signal generator may be, for example, a receiver coil such as the receiver coil 434, a hall effect sensor or magnet, and / or any other proximity sensor and the sensor may be, for example, a sense coil such as the sense coil 436B, a hall effect sensor or magnet, and / or any other proximity sensor.

[0139] The method 800 also comprises processing the sensor data and / or the signals (step 808). The sensor data may be processed by a processor such as the processor 104, 126 using a sensor processing such as the sensor processing 120. The sensor processing enables the processor to process the sensor data from one or more sensor(s) of the second device for the purpose of, for example, obtaining a magnitude of a reading for at least one sensor of the sensor(s). In embodiments where the signal generator is a receiver coil and the sensor is a plurality of sense coils, the sensor data may comprise, for example, one or more amperes. In other embodiments where the signal generator is a magnet and the sensor is a Hall sensor, the sensor data may comprise, for example, a Hall voltage. The magnitude of, for example, the amperes or Hall voltage (or any other sensor data), may be used by the alignment feedback generation to provide feedback regarding an alignment of the second device relative to the first device.

[0140] It will be appreciated that in other embodiments, the signal generator and / or the sensor may be any sensor configured to sense proximity of the first device relative to the second device. It will also be appreciated that any number of signal generator and / or sensors may be used. For example, two or more signal generators and / or sensors may be used to aid in providing feedback about an orientation of the second device relative to the first device.

[0141] The method 800 also comprises determining an alignment feedback (step 812). The alignment feedback may be determined by the processor using an alignment feedback generation such as the alignment feedback generation 122. The alignment feedback generation enables the processor to receive the processed sensor data from, for example, the sensor processing for the purpose of providing feedback regarding the alignment of the second device relative to the first device.

[0142] In embodiments where the signal generator is a receiver coil and the sensor is a plurality of sense coils, ampere readings from the sense coils may be used to determine the alignment feedback. For example, if the receiver coil is positioned closer to at least one of the sense coils, such sense coil(s) will have a greater ampere reading and the remaining sense coil(s) will have a corresponding lower ampere reading. Thus, a reading of the amperes may provide directional information where the sense coil(s) with a greater amp reading indicates that the recharger is close to those sense coil(s). Thus, the directional information can be used to communicate to the patient to move the recharger away from the sense coil(s) with the greater ampere reading.

[0143] In embodiments where the signal generator is one or more magnets and the sensor is a Halls effect sensor, the at least one magnet may be located on or integrated with a pump such as the pump 214 of the therapeutic delivery system or a template such as the template 232 of the refill kit and the at least one hall sensor may be located on or integrated with the pump or the template. The at least one magnet and the at least one hall sensor may be used to determine when the template is within a desired proximity or position of the pump when the at least one magnet is within the desired proximity or position of the at least one Hall sensor to induce a measurable Hall voltage. The magnitude of the Hall voltage may be obtained from the sensor processing as described above, and the Hall voltage can then be processed by the alignment feedback generation to determine whether the measurable Hall voltage is within a predetermined threshold corresponding to a desired placement of the template relative to the pump. The alignment feedback may include, for example, a notification of whether the template is aligned (e.g., when the magnitude of the Hall voltage is at or below the predetermined threshold) or misaligned (e.g., when the magnitude of the Hall voltage is above the predetermined threshold) with the pump.

[0144] The method 800 also comprises displaying the alignment feedback (step 816). The alignment feedback may be displayed on a feedback display such as the feedback display 136 of the second device and / or a user interface such as the user interface 110 of a computing device such as the computing device 100. In some embodiments wherein the first device is the pump of the therapeutic delivery system and the second device is the template of the refill kit, the feedback display includes an LED on the template of the refill kit that may activate when the template is in the desired position relative to the pump. In other embodiments, the feedback display may provide any visual feedback, audible feedback, and / or tactile feedback to indicate alignment of the template relative to thepump. Additionally or alternatively, the user interface may include a graphical display with information such as, for example, refill remaining time, status of the refill, etc.

[0145] In embodiments where the first device is the implantable device of the neuromodulation therapy system and the second device is the recharger, the alignment feedback may be communicated to the patient as alignment feedback via the feedback display and / or the user interface of the computing device. In such embodiments, acceleration data may be used to determine a position of the alignment feedback relative to the patient. For example, some visual feedback can be dependent on a position of the patient relative to the feedback display and such feedback display may change depending on the position of the patient. In other embodiments, the alignment feedback may also display the device in an orientation correlating to an actual orientation of the device relative to, for example, the patient. The orientation of the device may be obtained from, for example, accelerometer data, though it will be appreciated that the orientation of the device may be obtained from any type of data correlating to the orientation of the device (e.g., gyroscopic data, orientation data, etc.). Such data may be obtained from a sensor positioned on, for example, the device and / or the recharger.

[0146] In some embodiments, the feedback display may include a plurality of LEDs such as the plurality of LEDs 440 and each LED may correspond to a sense coil of the plurality of sense coils. When the receiver coil of the implantable device is positioned closer to one of the sense coils, the corresponding LED may illuminate red while the other LEDs may illuminate green to indicate that the receiver coil should be moved away from the LED that is red. It will be appreciated that the LEDs 440 may illuminate any color or may not illuminate. When the receiver coil is centered on the recharger coil, all of the plurality of LEDs may illuminate green, or may not illuminate at all. Thus, the plurality of LEDs may provide directional information to the patient such that the patient can move the recharger to a target alignment.

[0147] In other embodiments, the feedback display may provide any visual feedback, audible feedback, and / or tactile feedback to indicate alignment of the recharge coil relative to the receiver coil. Additionally or alternatively, the user interface may include a graphical display to indicate a quality of the alignment, a time to complete recharge, next recharge time, etc. as will be discussed in Figs. 16-18. The feedback display may also include an alignment quality corresponding to whether the one or more sensors is aligned with the one or more signal generators. More specifically, the alignment quality may corresponding to whether one or more transducers of the one or more sensors is alignedwith one or more transducers of the one or more signal generators. The alignment quality may correspond to alignment of the one or more signal generators and the one or more sensors when the one or more signal generators and the one or more sensors are within a proximal distance of each other that is below a proximal distance threshold and when the one or more sensors is oriented relative to the one or more signal generators at a target orientation. Similarly, the alignment quality may correspond to misalignment of the one or more signal generators and the one or more sensors when at least one of the one or more signal generators and the one or more sensors are within the proximal distance of each other that is above the proximal distance threshold or when the one or more sensors is not oriented relative to the one or more signal generators at the target orientation. In some embodiments, the alignment feedback may include an offset distance or an offset angle when the first and sensors are misaligned that is displayed on the feedback display and / or the user interface.

[0148] The present disclosure encompasses embodiments of the method 800 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0149] Figs. 9-12 will be described together. Fig. 9 depicts a method 900 that may be used, for example, for generating a custom recharge profile and alignment feedback for a user such as, for example, a patient. Fig. 10 depicts a first chart 1000 illustrating patient recharge intervals and Fig. 11 depicts a second chart 1100 illustrating patient recharge amounts. Fig. 12 illustrates an example notification displayed on, for example, a user interface.

[0150] The method 900 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 and / or the processor 126 of the second device 116 described above. A processor other than any processor described herein may also be used to execute the method 900. The at least one processor may perform the method 900 by executing elements stored in a memory such as the memory 106, 128. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 900. One or more portions of a method 900 may be performed by the processor executing any of the contents of memory, such a sensor processing 120, an alignment feedback generation 122, and / or a recharge profile model generation 124.

[0151] The method 900 comprises receiving one or more patient inputs (step 904). The one or more patient inputs may be input received to generate a custom recharge profile for a patient that uses a recharger such as the recharger 430 to recharge an implantable device such as the implantable device 402 of a neuromodulation therapy system such as the neuromodulation therapy system 400. The implantable device may correspond to a first device such as the first device 112 and the recharger may correspond to a second device such as the second device 116. The one or more patient inputs may be received from, for example, a user interface such as the user interface 110 of a computing device such as the computing device 102, a memory such as the memory 106, 128, a database such as the database 130, a cloud such as the cloud 134, the implantable device, and / or the recharger.

[0152] The one or more patient inputs may include a recharge duration for the implantable device using the recharger, a recharge interval (e.g., how often the implantable device is recharged), and / or a pattern of recharging (e.g., time of day, week, or month). As shown in the chart 1000 of Fig. 10, some patients may recharge on a consistent schedule whereas some patients may recharge variably. Still other patients may recharge at specific times that results in variable end capacity after recharge. For example, Patent 1’s recharge interval is consistent whereas Patent 5’s recharge interval is variable. The one or more patient inputs may also include the patient’s typical or average battery depletion before recharging the implantable device. For example, some patients may recharge the implantable device when a battery such as the battery 432 is 50% depleted, whereas other patients may recharge the implantable device when the battery is 90% depleted. Similarly, the one or more patient inputs may include average recharge amount. As shown in the chart 1100 of Fig. 11, some patients may recharge the battery to full, whereas other patients may recharge the battery to less than full.

[0153] The one or more patient inputs may also include information about the implantable device. For example, the one or more patient inputs may include a depth, pose, and / or orientation of the implantable device, which may impact a target position of the recharger relative to the implantable device. In some embodiments, a image such as, for example, an X-ray of the implantable device may be provided as a patient input. The one or more patient inputs may also include the type of implantable device, the type of battery, and / or any other parameters of the implantable device or the neuromodulation system.

[0154] The one or more patient inputs may also include patient movement and / or a patient position (which may be obtained from, for example, accelerometer data) during arecharge session, which may impact a target position of the recharger relative to the implantable device as the implantable device may shift or move to a different depth and / or position based on the patient’s movement and / or position. For example, the recharger may have a target position when a patient is sitting that is different from a target position when the patient is standing. The patient input may also include the patient preference on notification type (e.g., beeping volume, brightness of notification, color settings, vibration settings, audible settings, etc.).

[0155] It will be appreciated that inputs may be weighted or scaled differently when generating the recharge profile (discussed below). For example, the battery depletion and the pattern of recharging may be weighted or scaled more heavily for a patient that prefers a consistent schedule of recharging (e.g., daily, every two days, etc.). In another example, a recharge interval and battery depletion may be weighted or scaled more heavily for a patient that prefers maximizing the interval of recharge. Thus, the recharge profile is customized for each patient.

[0156] The method 900 also comprises generating a recharge profile (step 908). The recharge profile may be generated by a processor such as the processor 104, 126 using a recharge profile generation such as the recharge profile generation 124. The recharge profile generation may receive patient input in, for example, the step 904 described above. The recharge profile generation may also receive a time to battery full and / or a time to battery empty as input.

[0157] The recharge profile generation may use a learning algorithm as taught in U.S. Patent Application Serial No. 17 / 652,241 - U.S. Patent Application Publication No. 2022 / 0271575-Al entitled “Learning Algorithm for Recharge System Feedback Threshold”, which is incorporated by reference in its entirety to generate the recharge profile. The recharge profile can include notification type (e.g., beeping volume, brightness of notification, color settings, vibration settings, audible settings, etc.), thresholds for feedback alignment of the recharger relative to the implantable device, thresholds for the recharge process, an estimated time to battery empty, a target battery capacity, etc.

[0158] More specifically with respect to the estimated time to battery empty, the time to battery empty may be based on historical patient data. For example, the patient’s typical usage pattern may be averaged across a timeframe of a month, a week, a day, etc. The historical patient data may be the patient’s own data or may be data of other patients with parameter(s) similar to the patient. Additionally or alternatively, the instantaneous currentmeasurement of the implantable device may be used to also estimate the time to battery empty. The instantaneous current measurement may be stored over time in, for example, memory such as the memory 106, 128 or obtained from recharge logs from the recharger and information about the battery state of charge from the recharger or the implantable device. The estimated time to battery empty may also be based on the current settings and / or therapy groups of the implantable device. The estimated time to battery empty may be updated if, for example, the patient or a healthcare provider changes the settings, parameters, and / or therapy groups of the implantable device. The various inputs may be weighted based on the patient’s usage. For example, in some embodiments, instantaneous current draw may be preferred for patients who are not frequently changing their stimulator groups / settings. In other embodiments, average current draw may be preferred if the patient has a specific way changing their settings across pre-defined time (example: changing stimulator settings every day at night).

[0159] The method 900 also comprises recharging a first device with a second device (step 912). Recharging the first device or the implantable device (and more specifically, the battery) with the second device or the recharger may include positioning the recharger relative to the implantable device until the recharger is aligned with the implantable device. Alignment and / or alignment feedback of the recharger relative to the implantable device may be communicated to the user using, for example, the method 800 described above.

[0160] The first device or the implantable device may be charged for a time period set by the recharger profile and / or by the patient. For example, the recharger profile may initially set the time period and the patient may adjust the time period.

[0161] The method 900 also comprises receiving recharge input(s) (step 916). One or more recharge inputs during the time period may be received by the processor of the computing device or the second device. The recharge inputs may include, for example, a state of charge of the battery, an alignment quality (e.g., whether the second device is at a target position relative to the first device), etc.

[0162] The method 900 also comprises generating a notification (step 920). The notification may be a visual notification, a tactile notification, an audible notification, a combination of notification types, or any type of notification communicated to a user. The notification may be customized based on user preference. For example, the notification may be specific beeping, buzzing, and / or vibrations at a desired volume, pattern, and / or duration. The notification may be communicated to the user via the feedback displayand / or the user interface. In some embodiments, the notification may be automatically generated by the processor. In other embodiments, the notification may be automatically generated by any component of a system such as the system 100.

[0163] The one or more recharge input(s) may trigger a notification during or after the recharge process. For example, a notification may be generated when the alignment quality is low and indicates that the recharger or second device can be moved to a more optimal position. In another example, a notification may be generated when the recharge is complete and the recharge has deviated from a typical recharge for the patient. For example, if the recharge took more time than an average recharge time for the patient, a notification may be generated to ask the patient whether a new recharge reminder should be set.

[0164] During the recharge process, the sensory feedback such as the beeping threshold for poor alignment of the recharger with the implantable device may be adjusted from defaults based on analysis of the patient’s recharge coupling data. In other embodiment, the sensory feedback may be gradually changed based on increasing or decreasing recharge coupling data (volume, speed, tone, vibration pattern).

[0165] It will be appreciated that the notification may be generated without the steps 912 and / or 916. In other words, notifications may be generated outside of the recharge process. For example, in Fig. 12, an example notification 1202 is shown displayed on the user interface of an example computing device. As shown, the notification may be an estimated time to battery empty and / or an estimated time to recharge, which may be determined in, for example, the step 908 described above.

[0166] The notification may also provide daily, weekly, or monthly reports on the patient’s specific recharging experience. For example, the report may provide a recommendation on whether to top-off the battery state of charge for a given recharging process and / or recommendations on an optimal recharging schedule.

[0167] The method 900 also comprises receiving one or more updated patient inputs (step 924). The step 924 may be the same as or similar to the step 904 except that the patient inputs are one or more updated patient inputs received after the recharger profile was generated in, for example, the step 908.

[0168] The method 900 also comprises updating the recharger profile (step 928). The step 928 may be the same as or similar to the step 908 except that the recharger profile is updated based on the one or more updated patient inputs received in, for example, the step 924.

[0169] It will be appreciated that any combination of steps may be repeated. For example, the steps 924 and 928 may be repeated multiple times as the patient inputs are updated or changes throughout the patient’s use of the implantable device and the recharger. Thus, the recharger profile can be customized, updated, and maintained for the patient’s specific needs, even as the patient’s needs may change.

[0170] The present disclosure encompasses embodiments of the method 900 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0171] Figs. 13-17 will be described together. Fig. 13 depicts a method 1300 that may be used, for example, for generating and displaying a recharge indicator. Fig. 14 depicts an example chart for scaling a recharge indicator. Fig. 15 depicts another example chart for scaling the recharge indicator. Fig. 16 depicts an example user interface for displaying the recharge indicator. Fig. 17 depicts another example user interface.

[0172] The method 1300 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 and / or the processor 126 of the second device 116 described above. A processor other than any processor described herein may also be used to execute the method 1300. The at least one processor may perform the method 1300 by executing elements stored in a memory such as the memory 106, 128. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 1300. One or more portions of a method 1300 may be performed by the processor executing any of the contents of memory, such a sensor processing 120, an alignment feedback generation 122, and / or a recharge profile model generation 124.

[0173] The method 1300 comprises receiving one or more patient inputs (step 1304). The step 1304 may be the same as or similar to the step 904 of the method 900 described above.

[0174] The method 1300 also comprises generating an upper limit and a lower limit of a recharge indicator (step 1308). The recharge indicator may correspond to an alignment quality of a position of the second device or recharger relative to the first device or implantable device. As shown in Fig. 16, a recharge indicator 1600 is shown in an example user interface having an upper limit 1602 corresponding to an optimal alignment and a lower limit 1604 corresponding to a suboptimal alignment or misalignment. In the illustrated embodiment, the recharge indicator may be a recharge window.

[0175] Because a position of a patient’s implantable device varies between each patient, an optimal alignment between the first device and the second device may also vary. In other words, an optimal alignment for one patient may not be achievable for a second patient. Thus, custom limits of the recharge indicator are beneficial in encouraging a patient to position the second device relative to the first device based on an optimal alignment for that particular patient.

[0176] The upper limit and the lower limit may be based on the one or more patient inputs received in, for example, the step 1304. In some embodiments, the upper limit and the lower limit are scaled based on a last number of recharge sessions, parameters of most optimal recharge sessions, duration of recharge, recharging mode, and / or known scaling factors due to implementation details of how a recharger power can be adjusted over time. For example, as shown in Figs. 14 and 15, a first set of scaling factors 1400 based on a recharger mode and a second set of scaling factors 1500 based on charging time are shown.

[0177] The method 1300 also comprises displaying the recharge indicator and a status of a recharge (step 1312). The recharge indicator and the status of the recharge may be displayed on the user interface shown in Figs. 16 and 17. As previously described, the recharge indicator includes an upper limit and a lower limit displayed as, for example, a position gauge. A dial 1610 and a position notification 1606 indicates the alignment quality. As the second device is positioned relative to the first device, the dial 1610 may move accordingly. Additionally, the position notification 1606 may update and include a textual description of the alignment quality. For example, as illustrated, the position notification 1606 indicates that the position of the second device can be improved. In other examples, the position notification 1606 may include a direction in which to move the second device, which may be obtained from, for example, the method 700 described above.

[0178] The user interface may also display any other notifications 1608 such as, for example, a time to next recharge, a time to full, and a time to empty. The notifications 1608 may also include any other notification such as notification(s) described in the step 920 of the method 900 above.

[0179] The method 1300 also comprises receiving one or more updated patient inputs (step 1316). The step 1316 may be the same as or similar to the step 924 of the method 900 described above.

[0180] The method 1300 also comprises updating the upper limit and the lower limit of the recharge indicator (step 1320). The step 1320 may be the same as or similar to the step 928 of the method 900 described above except that the upper limit and the lower limit of the recharge indicator are updated based on the updated patient inputs.

[0181] It will be appreciated that any combination of steps may be repeated. For example, the steps 1316 and 1320 may be repeated multiple times as the patient inputs are updated or changes throughout the patient’s use of the implantable device and the recharger. Thus, the recharge indicator can be customized, updated, and maintained for the patient’s specific needs.

[0182] The present disclosure encompasses embodiments of the method 1300 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0183] Fig. 18 depicts a method 1900 that may be used, for example, for generating an expiration interval.

[0184] The method 1900 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 and / or the processor 126 of the second device 116 described above. A processor other than any processor described herein may also be used to execute the method 1900. The at least one processor may perform the method 1900 by executing elements stored in a memory such as the memory 106, 128. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 1900. One or more portions of a method 1900 may be performed by the processor executing any of the contents of memory, such a sensor processing 120, an alignment feedback generation 122, and / or a recharge profile model generation 124.

[0185] The method 1900 comprises receiving one or more patient inputs (step 1904). The step 1904 may be the same as or similar to the step 904 of the method 900 described above.

[0186] The method 1900 also comprises generating an expiration interval (step 1808). The expiration interval corresponds to a time that security key(s) between the recharger and the implantable device will expire. Such security key(s) between the recharger and the implantable device are routinely paired or refreshed and may take a substantial amount of time that can interrupt a recharging process. In particular, a beginning period of a rechargeprocess is sensitive to disruptions. Thus, it is desirable to time the expiration interval outside of a recharge process or at least after a beginning of a recharge process.

[0187] To avoid such disruptions during the recharge process, the expiration interval may be set to a fixed value derived from recharge interval of typical patients. In other instances, the expiration interval may be dynamically adjusted for a patient. For example, if a patient is known to recharge their implantable device every day at a certain time, the expiration interval may be set to expire prior to or after the recharge process is likely to occur.

[0188] The method 1900 also comprises recharging the first device for a time period (step 1812). The step 1812 may be the same as or similar to the step 912 of the method 900 above. As described above, the expiration interval is set to expire after a first period of the time period or outside of the time period so as to not disrupt the recharging process during a pivotal period of the recharging process.

[0189] The method 1900 also comprises receiving one or more updated patient inputs (step 1816). The step 1816 may be the same as or similar to the step 924 of the method 900 described above.

[0190] The method 1900 also comprises updating the expiration interval (step 1820). The step 1820 may be the same as or similar to the step 928 of the method 900 described above except that the expiration interval may be updated based on the one or more updated patient inputs.

[0191] It will be appreciated that any combination of steps may be repeated. For example, the steps 1916 and 1920 may be repeated multiple times as the patient inputs are updated or changes throughout the patient’s use of the implantable device and the recharger. Thus, the expiration interval can be customized, updated, and maintained for the patient’s specific needs.

[0192] The present disclosure encompasses embodiments of the method 1900 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0193] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Figs. 8, 9, 13, 18, and 21 (and the corresponding description of the methods 800, 900, 1300, 1800 and 2100), as well as methods that include additional steps beyond those identified in Figs. 8, 9, 13, 18, and 21 (and the corresponding description of the methods 800, 900, 1300, 1800, and 2100). The present disclosure also encompasses methods that comprise one or more steps from one method described herein,and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

[0194] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0195] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0196] The following statements provide non-limiting examples of systems and methods for generating, providing, and / or displaying alignment feedback:

[0197] Statement 1. A system for providing alignment feedback, the system comprising: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors and a feedback display configured to provide alignment feedback corresponding to a quality of an alignment of the one or more sensors relative to the one or more signal generators a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more sensor data from the one or more signal generators and the one or more sensors; process the one or more sensor data to determine an amplitude ofthe one or more sensors; determine the alignment feedback based on the processed one or more sensor data; and display the alignment feedback by the feedback display.

[0198] Statement 2. The system of Statement 1, wherein the alignment feedback includes an alignment quality corresponding to whether the one or more sensors is aligned with the one or more signal generators.

[0199] Statement 3. The system of Statement 2, wherein the alignment quality corresponds to alignment of one or more transducers of the one or more signal generators and one or more transducers of the one or more sensors when the one or more signal generators and the one or more sensors are within a proximal distance of each other that is below a proximal distance threshold and when the one or more sensors is oriented relative to the one or more signal generators at a target orientation.

[0200] Statement 4. The system of Statements 1 or 2, wherein the alignment quality corresponds to misalignment of the one or more signal generators and the one or more sensors when at least one of the one or more signal generators and the one or more sensors are within the proximal distance of each other that is above the proximal distance threshold or when the one or more sensors is not oriented relative to the one or more signal generators at the target orientation.

[0201] Statement 5. The system of any of the preceding Statements, wherein the alignment feedback includes an offset distance or an offset angle when the alignment quality corresponding to the misalignment.

[0202] Statement 6. The system of any of the preceding Statements, wherein the first device is at least one of an implantable stimulator or a pump and the second device is at least one of a recharger or a refill device.

[0203] Statement 7. The system of Statement 6, wherein the feedback display is integrated with a template of the refill device.

[0204] Statement 8. The system of Statement 6, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

[0205] Statement 9. The system of Statement 8, wherein the feedback display comprises a plurality of lights, each light positioned in proximity to a corresponding sensing coil, and wherein at least one light of the plurality of lights illuminates when the receiver coil is near the corresponding sensing coil.

[0206] Statement 10. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient, the first device having one or moresignal generators; a second device having one or more sensors; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an upper limit and a lower limit of a recharge indicator based on the one or more patient inputs; and display the recharge indicator and a status of a recharge within the recharge indicator.

[0207] Statement 11. The system of Statement 10, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the upper limit and the lower limit based on the one or more updated patient inputs.

[0208] Statement 12. The system of Statements 10 or 11, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0209] Statement 13. The system of any of the preceding Statements, wherein the recharge indicator is displayed as a gauge with a dial that moves along the gauge between the upper limit and the lower limit.

[0210] Statement 14. The system of Statement 13, wherein the upper limit corresponds to an optimal alignment between the first device and the second device, the lower limit corresponds to a suboptimal alignment between the first device and the second device, and the dial corresponds to an alignment quality.

[0211] Statement 15. The system of Statement 14, wherein the alignment quality is determined from the one or more signal generators and the one or more sensors.

[0212] Statement 16. The system of Statement 15, wherein the upper limit and the lower limit are based on a scaling factor determined from the one or more patient inputs.

[0213] Statement 17. The system of any of the preceding Statements, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

[0214] Statement 18. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate the recharge profile based on the one or more patient inputs; recharge the first device using the second device for a time period; receive one or more recharger inputs during the time period; and generate a notification based on the one or more recharger inputs and the recharger profile.

[0215] Statement 19. The system of Statement 18, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

[0216] Statement 20. The system of Statements 18 or 19, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0217] Statement 21. The system of any of the preceding Statements, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

[0218] Statement 22. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate a recharge profile; generate a notification based on the recharge profile; receive one or more updated patient inputs; and update the recharge profile.

[0219] Statement 23. The system of Statement 22, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0220] Statement 24. The system of Statements 22 or 23, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

[0221] Statement 25. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an expiration interval based on the one or more patient inputs; and recharge the first device using the second device for a time period, wherein the expiration interval expires outside of the time period.

[0222] Statement 26. The system of Statement 25, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

[0223] Statement 27. The system of Statements 25 or 26, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0224] Statement 28. The system of any of the preceding Statements, wherein the expiration interval corresponds to a time interval that a security key between the first device and the second device will expire.

[0225] Statement 29. A system for providing alignment feedback, the system comprising: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors and a feedback display configured to provide alignment feedback of the one or more sensors relative to the one or more signal generators, wherein one or more signals are received from the one or more signal generators by the one or more sensors, and wherein the one or more sensors provide alignment feedback based on the one or more signals.

[0226] Statement 30. The system of Statement 29, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

[0227] Statement 31. The system of Statements 29 or 30, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises one or more sense coils.

[0228] Statement 32. The system of any of the preceding Statements wherein the alignment feedback is displayed by one or more light displays, and wherein the one or more light displays activate based on sensor data received from the one or more sensors.

[0229] Statement 33. The system of Statement 32, wherein the one or more light displays comprises one or more light emitting diodes (LEDs).

Claims

CLAIMSWhat is claimed is:

1. A system for providing alignment feedback, the system comprising: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors and a feedback display configured to provide alignment feedback corresponding to a quality of an alignment of the one or more sensors relative to the one or more signal generators a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more sensor data from the one or more signal generators and the one or more sensors; process the one or more sensor data to determine an amplitude of the one or more sensors; determine the alignment feedback based on the processed one or more sensor data; and display the alignment feedback by the feedback display.

2. The system of claim 1, wherein the alignment feedback includes an alignment quality corresponding to whether the one or more sensors is aligned with the one or more signal generators.

3. The system of claim 2, wherein the alignment quality corresponds to alignment of one or more transducers of the one or more signal generators and one or more transducers of the one or more sensors when the one or more signal generators and the one or more sensors are within a proximal distance of each other that is below a proximal distance threshold and when the one or more sensors is oriented relative to the one or more signal generators at a target orientation.

4. The system of claims 1 or 2, wherein the alignment quality corresponds to misalignment of the one or more signal generators and the one or more sensors when at least one of the one or more signal generators and the one or more sensors are within theproximal distance of each other that is above the proximal distance threshold or when the one or more sensors is not oriented relative to the one or more signal generators at the target orientation.

5. The system of any of the preceding claims, wherein the alignment feedback includes an offset distance or an offset angle when the alignment quality corresponding to the misalignment.

6. The system of any of the preceding claims, wherein the first device is at least one of an implantable stimulator or a pump and the second device is at least one of a recharger or a refill device.

7. The system of claim 6, wherein the feedback display is integrated with a template of the refill device.

8. The system of claim 6, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

9. The system of claim 8, wherein the feedback display comprises a plurality of lights, each light positioned in proximity to a corresponding sensing coil, and wherein at least one light of the plurality of lights illuminates when the receiver coil is near the corresponding sensing coil.

10. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient, the first device having one or more signal generators; a second device having one or more sensors; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an upper limit and a lower limit of a recharge indicator based on the one or more patient inputs; anddisplay the recharge indicator and a status of a recharge within the recharge indicator.

11. The system of claim 10, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the upper limit and the lower limit based on the one or more updated patient inputs.

12. The system of claims 10 or 11, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

13. The system of any of the preceding claims, wherein the recharge indicator is displayed as a gauge with a dial that moves along the gauge between the upper limit and the lower limit.

14. The system of claim 13, wherein the upper limit corresponds to an optimal alignment between the first device and the second device, the lower limit corresponds to a suboptimal alignment between the first device and the second device, and the dial corresponds to an alignment quality.

15. The system of claim 14, wherein the alignment quality is determined from the one or more signal generators and the one or more sensors.

16. The system of claim 15, wherein the upper limit and the lower limit are based on a scaling factor determined from the one or more patient inputs.

17. The system of any of the preceding claims, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises a plurality of sensing coils.

18. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient; a second device configured to recharge the first device;a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate the recharge profile based on the one or more patient inputs; recharge the first device using the second device for a time period; receive one or more recharger inputs during the time period; and generate a notification based on the one or more recharger inputs and the recharger profile.

19. The system of claim 18, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

20. The system of claims 18 or 19, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

21. The system of any of the preceding claims, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

22. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate a recharge profile; generate a notification based on the recharge profile; receive one or more updated patient inputs; and update the recharge profile.

23. The system of claim 22, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

24. The system of claims 22 or 23, wherein the notification comprises at least one of a recharge interval, a time to recharge, a time to full charge, an alignment quality, a time to empty, and / or a deviation from a typical recharge.

25. A system for generating a recharge profile, the system comprising: a first device configured to be implanted in a patient,; a second device configured to recharge the first device; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive one or more patient inputs; generate an expiration interval based on the one or more patient inputs; and recharge the first device using the second device for a time period, wherein the expiration interval expires outside of the time period.

26. The system of claim 25, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive one or more updated patient inputs; and update the recharge profile based on the one or more updated patient inputs.

27. The system of claims 25 or 26, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

28. The system of any of the preceding claims, wherein the expiration interval corresponds to a time interval that a security key between the first device and the second device will expire.

29. A system for providing alignment feedback, the system comprising: a first device configured to be implanted in a patient, the first device having one or more signal generators;a second device having one or more sensors and a feedback display configured to provide alignment feedback of the one or more sensors relative to the one or more signal generators, wherein one or more signals are received from the one or more signal generators by the one or more sensors, and wherein the one or more sensors provide alignment feedback based on the one or more signals.

30. The system of claim 29, wherein the first device comprises an implantable stimulator and the second device comprises a recharger.

31. The system of claims 29 or 30, wherein the one or more signal generators comprises a receiver coil and the one or more sensors comprises one or more sense coils.

32. The system of any of the preceding claims wherein the alignment feedback is displayed by one or more light displays, and wherein the one or more light displays activate based on sensor data received from the one or more sensors.

33. The system of claim 32, wherein the one or more light displays comprises one or more light emitting diodes (LEDs).

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