Search

AU-2023268455-A1 - SYSTEM AND METHOD FOR ALIGNING A CHARGER FOR AN IMPLANTED MEDICAL DEVICE

AU2023268455A1AU 2023268455 A1AU2023268455 A1AU 2023268455A1AU-2023268455-A1

Abstract

Devices, systems and methods for improving alignment of a charging device with an implanted medical device are disclosed herein. The system can include an external charging device that communicates one or more charge parameters during charging to a user device having an alignment feature that is embodied in a software application that displays a real-time charging efficiency indicator based on the charge parameters. This alignment feature allows determination of an optimal position by observing charging efficiency while moving the charging device during charging. The application and device may be configured for use by a specialist, such as a field technician or representative of the device provider, to aid the patient. The system can further include a charging device configured for use with the application and having additional charging functionality. The alignment feature may be included for training and/or troubleshooting charging alignment problems experienced by certain patients.

Inventors

  • SAMA RINDA
  • ABDEEN FAIZAL

Assignees

  • AXONICS INC

Dates

Publication Date
20241205
Application Date
20230510
Priority Date
20220511

Claims (20)

  1. 1. A system for facilitating alignment between an external charging device and an implantable medical device in a patient, the system comprising: an external charging device having a charging coil disposed within a housing and configured to magnetically couple with a corresponding receiving coil of the implantable medical device, wherein the external charging device includes an antenna configured for communicating with one or more external devices, and a processor configured to control charging with the charging coil and monitor one or more charging parameters during charging, wherein the external charging device comprises one or more indicators that are configured to indicate a first-order alignment of the external charging device with the implantable medical device and effect charging upon detection of the first-order alignment; and a portable user device, the portable user device having a housing, an antenna for communicating with at least one of the external charging device and the implantable medical device, a user interface, and a processor operably coupled to the antenna, the user interface and a memory having stored thereon a software application configured for at least one of training and troubleshooting of charging, wherein the software application includes executable instructions configured to: establish communication with the external charging device; receive a communication of the one or more charging parameters or an associated charging metric during charging; and display a charging efficiency indicator in real-time that corresponds to a fine-tuned alignment between the external charging device and the implantable medical device, wherein the charging efficiency indicator is based on the one or more charging parameters or the associated charging metric.
  2. 2. The system of claim 1, wherein the portable user device is configured for use by a specialist who is at least one of a field technician, a representative, and a clinical care specialist associated with a provider of the implantable medical device.
  3. 3. The system of claim 1, wherein the software application includes a secure logon to ensure secure connection between the portable user device and the external charging device.
  4. 4. The system of claim 1, wherein the portable user device is a tablet device.
  5. 5. The system of claim 1, wherein the external charging device is configured to communicate by a first type of communication with the implantable medical device and to communicate by a second type of communication with the portable user device.
  6. 6. The system of claim 5, wherein the first type of communication is MedRadio and the second type of communication is Bluetooth.
  7. 7. The system of claim 1, wherein external charging device is a specialized charging device configured for use with the software application.
  8. 8. The system of claim 7, wherein the external charging device is configured for use only by a specialist.
  9. 9. The system of claim 7, wherein the external charging device includes an accelerated charging mode that operates with increased charging parameters as compared to a standard charging mode of a standard charging device of the patient.
  10. 10. The system of claim 9, wherein the external charging device is configured to charge the implantable medical device in the accelerated charging mode when the implantable medical device is in a hibernation and/or a low battery state at least until communication may be established.
  11. 11. The system of claim 10, wherein the external charging device is further configured to charge the implantable medical device at a same rate as the standard charging mode after communication is established.
  12. 12. The system of claim 1, wherein the software application is configured to display the charging efficiency indicator on a main display screen that further displays one or more additional indicators.
  13. 13. The system of claim 12, wherein the charging efficiency indicator is a bar extending between multiple differing charging efficiency levels, wherein the bar dynamically updates to show a current charging efficiency level in real-time.
  14. 14. The system of claim 13, wherein the charging efficiency indicator further shows a peak level during a charging session.
  15. 15. The system of claim 14, wherein the one or more additional indicators include a charging efficiency history indicator.
  16. 16. The system of claim 14, wherein the one or more additional indicators further include a battery charge status.
  17. 17. The system of claim 14, wherein the one or more additional indicators further include a connection status.
  18. 18. The system of claim 14, wherein the one or more additional indicators further include a charging time indicator.
  19. 19. The system of claim 18, wherein the charging time indicator comprises one or both of an estimated charging time remaining and a total estimated charging time.
  20. 20. A method of positioning an external charging device relative to an implantable medical device, the method comprising: establishing communication between a processing device and an external charging device, wherein the charging device is configured for transcutaneously charging of an implanted medical device and the processing device having a software application thereon for assessing charging alignment; charging the implantable medical device with the external charging device when at least a first-order alignment is achieved; receiving, with the processing device, one or more charging parameters or an associated charging metric from the external charging device during transcutaneous charging of the implanted medical device; displaying on a display of a user device with the software application, a real-time charging efficiency indicator based on the one or more charging parameters or metric, wherein the charging efficiency indicator corresponds to a fine-tuned alignment between the external charging device and the implanted medical device; and moving the external charging device on the patient in response to variations in the charging efficiency indicator, shown on the display, to determine an optimal position of the external charging device for charging.

Description

SYSTEM AND METHOD FOR ALIGNING A CHARGER FOR AN IMPLANTED MEDICAL DEVICE CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application No. 63/340,827, entitled “Implanted Medical Device Charger Alignment Tools and Methods for Use, Training, and Trouble Shooting,” filed on May 11, 2022, which is incorporated herein by reference in its entirety for all purposes. [0002] The present application is also generally related to U.S. Non-Pro visional Application No. 17/522,644, entitled “Devices and Methods for Fine-Tuning Alignment of Charging Device with Implanted Medical Device,” filed on November 9, 2021, which is assigned to the same assignee and incorporated herein by reference in its entirety for all purposes. BACKGROUND [0003] The present application relates to implantable neurostimulation treatment systems and associated charging devices and methods. [0004] The prevalence of use of medical devices in treating ailments is increasing with time. In many instances, and as these medical devices are made smaller, these medical devices are frequently implanted within a patient. To power such devices, external charging devices that transcutaneously transfer energy to the implanted device are used to power the implanted device or to recharge a rechargeable battery of the implanted device. Such external charging devices typically utilize a charging coil that inductively couples with an internal coil of the implanted medical device. Efficient transcutaneous transfer of energy requires that the coils be suitably aligned. Misalignment can result in failure to recharge, inefficient recharging and/or excessive heat generation. While some conventional systems include features to indicate alignment, these features typically indicate merely when alignment is suitable for charging to take place within acceptable limits and typically do not facilitate precision placement to ensure optimal charging occurs. This can result in sub-optimal alignment that leads to prolonged recharging times and/or excessive heat generation. Further, current approaches of indicating alignment typically lack detailed guidance to facilitate the patient or clinician in providing precision alignment. [0005] Therefore, there exists a need for devices, systems and methods that facilitate improved, precision alignment between an external charging device and an implanted medical device. There is further need for an approach that provides guidance on improving alignment in a manner that is intuitive, interactive and utilizes features of existing systems. SUMMARY [0006] In one aspect, the subject matter pertains to charging of an implantable pulse generator by an external charging device, and particularly, devices and methods for improving alignment between charging coils of an implanted medical device and an external charging device. [0007] In some embodiments, the system is configured such that a device determines an alignment indicator based on charging efficiency determined from one or more charging parameters. The alignment indicator may be an output of the real-time charging efficiency during charging. The system outputs the indicator, which corresponds to alignment, during charging. Typically, the indicator indicates alignment without modifying the charging operation based on the alignment determination. This indicator facilitates a precision adjustment of alignment, either by the patient or clinician, during the charging operation. In one aspect, the alignment feature described herein may be incorporated into a user device of a specialist (e.g., field technician associated with the device manufacturer, clinical care specialist) to allow the specialist to assist the physician and/or patient in positioning the device. Such a feature is particularly advantageous for training after initial implantation and for troubleshooting alignment problems experienced by some patients. In some embodiments, the alignment feature may be embodied in a software application accessible/authorized for use only by the specialist, not by the patient, the treating physician or clinician device. In some embodiments, the alignment tools include a user device having the specialized software application thereon and configured for use with a standard charging device or a specialized charging device with added functionality. These aspects may be applied to any of the embodiments described herein. [0008] In some embodiments, the system includes a first indicator that indicates a first-order alignment (rough alignment) that corresponds to when alignment between coils is sufficient to inductively transfer energy for transcutaneously charging, and a second indicator that indicates a second-order alignment (precision alignment) within a range of suitable alignment positions to facilitate fine-tuned adjustment of alignment to increase charging efficiency and reduce charging time. In some embodiments, the system can include a third indi