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WO2025046392A1 - Systèmes et procédés de réglage d'un système de neuromodulation sur la base d'un niveau de batterie de système - Google Patents

Systèmes et procédés de réglage d'un système de neuromodulation sur la base d'un niveau de batterie de système Download PDF

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Publication number
WO2025046392A1
WO2025046392A1 PCT/IB2024/058087 IB2024058087W WO2025046392A1 WO 2025046392 A1 WO2025046392 A1 WO 2025046392A1 IB 2024058087 W IB2024058087 W IB 2024058087W WO 2025046392 A1 WO2025046392 A1 WO 2025046392A1
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WIPO (PCT)
Prior art keywords
battery level
battery
settings
processor
neuromodulation
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PCT/IB2024/058087
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English (en)
Inventor
William Paul Cook
Nathan A. Torgerson
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Medtronic Inc
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Medtronic Inc
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Publication of WO2025046392A1 publication Critical patent/WO2025046392A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters

Definitions

  • the present disclosure is generally directed to neuromodulation and, more specifically, is directed toward adjusting one or more settings of a neuromodulation system or device based on a battery level of a battery of the system or device.
  • 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.
  • a stimulation target e.g., nerves, non-neuronal cells, etc.
  • Unexpected lack of stimulation or blocking therapy may lead to patient dissatisfaction or pain.
  • Example aspects of the present disclosure include:
  • a system comprises a neuromodulation system configured to generate and deliver stimulation to a target anatomical region, the neuromodulation system having a battery to power the neuromodulation system; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor a battery level of the battery; adjust one or more settings of the neuromodulation system when the battery level meets or is below a predetermined battery level threshold.
  • the data further causes the processor to: generate a notification when the battery level meets or is below the predetermined battery threshold level, readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds the predetermined battery level threshold, wherein the one or more settings are readjusted to a set of initial values programmed when the battery level is above the predetermined battery level threshold level.
  • the data further causes the processor to: generate another notification when the one or more settings are readjusted to the set of initial values.
  • the predetermined threshold is a first predetermined threshold
  • the data further causes the processor to: readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds a second predetermined battery level threshold less than the first predetermined battery level threshold, and readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds the first predetermined battery level threshold.
  • any of the aspects herein wherein the one or more settings are changed to values different than the set of initial values when the battery level is above the second predetermined battery level threshold level and the one or more settings are changed to the set of initial values when the battery level is above the first predetermined battery level threshold level, and wherein values different than the set of initial values enables the neuromodulation system to provide stimulation using less energy from the battery.
  • adjusting the one or more settings includes changing a value of at least one setting of the one or more settings.
  • adjusting the one or more settings comprises at least one of lowering frequency parameter(s), adding cycling or changing the existing cycling time, adjusting an off-time cycling, adjusting a pulse width, changing a closed-loop neuromodulation to an open-loop neuromodulation, switching from using several groups in a program to only one, lowering amplitude settings, or changing electrodes.
  • the notification includes information about at least one of a remaining battery level or working hours left of the neuromodulation device.
  • the one or more settings comprises one or more stimulation parameters.
  • any of the aspects herein further comprising one or more sensors configured to sense at least one characteristic of the neuromodulation system, and wherein the data further causes the processor to: at least one of reduce power used or power down the one or more sensors when the battery level meets or is below the predetermined battery threshold level.
  • the predetermined battery level threshold is between about 10% and about 30% of a battery capacity of the battery.
  • the neuromodulation system includes a device configured to generate a stimulation and a lead configured to deliver the stimulation to a target anatomical region.
  • a system comprises a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region; a battery to power the device; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor a battery level of the battery; adjust one or more settings of the device when the battery level meets or is below a predetermined battery level threshold; and generate a notification when the battery level meets or is below the predetermined battery threshold level.
  • the data further causes the processor to: readjust the one or more settings of the device when the battery level meets or exceeds the predetermined battery level threshold, wherein the one or more settings are changed to a set of initial values programmed when the battery level is above the predetermined battery level threshold level.
  • the data further causes the processor to: generate another notification when the one or more settings are changed to the set of initial values.
  • any of the aspects herein further comprising one or more sensors configured to sense at least one characteristic of the device, and wherein the data further causes the processor to: at least one of reduce power used or power down the one or more sensors when the battery level meets or is below the predetermined battery threshold level.
  • the predetermined battery level threshold is between about 10% and about 30% of a battery capacity of the battery.
  • a system comprises a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region; a battery to power the device; a battery monitor configured to monitor a battery level of the battery; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor, using the batter monitor, a battery level of the battery; adjust one or more settings of the device when the battery level meets or is below a predetermined battery level threshold; and generate a notification when the battery level meets or is below the predetermined battery threshold level.
  • the battery monitor comprises a coulomb counter.
  • 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.
  • 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 XI -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).
  • FIG. 1 is a diagram of a system according to at least one embodiment of the present disclosure
  • Fig. 2 is a diagram of a pulse generator with leads connected to nerves according to at least one embodiment of the present disclosure
  • FIG. 3 is a diagram of a system according to at least one embodiment of the present disclosure.
  • Fig. 4 is a flowchart according to at least one embodiment of the present disclosure.
  • Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.
  • Fig. 6 is a flowchart according to at least one embodiment of the present disclosure.
  • 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-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., random-access memory (RAM), read-only memory (ROM), electrically erasable programmable 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).
  • data storage media e.g., random-access memory (RAM), read-only memory (ROM), electrically erasable programmable 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).
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i7 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Cortex Mx; Apple A10 or 10X Fusion processors; Apple Al l, Al 2, A12X, A12Z, or Al 3 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 discretes (DSPs), general purpose microprocessors
  • Neuromodulation systems used for neuromodulation may use rechargeable batteries that may require frequent charging.
  • neuromodulation systems or devices used for high energy applications such as deep brain stimulation or managing chronic pain require frequent charging.
  • Conventional neuromodulation systems continue to run the same therapy regardless of a battery level of the battery. In some instances, the patient may be warned about the battery level being low, however, the therapy will continue until the therapy cannot be provided and the neuromodulation system is turned off. The patient will then be without any therapy until the patient recharges the system.
  • Systems and methods according to the present embodiment beneficially change and/or adjust one or more settings of the neuromodulation system to adjust stimulation therapy to a stimulation therapy that uses less energy when the battery gets to a predefined low level or threshold in order to stretch or increase the time before they therapy is turned off.
  • the adjusted therapy may not be as effective as the original or initial therapy, but beneficially provides a low level of stimulation as opposed to having the stimulation turned off. Such adjusted therapy could prevent a debilitating condition that the patient may experience until they can recharge the neuromodulation system.
  • the systems and methods can include a neurostimulation system that is capable of monitoring its own battery levels such that when a certain level of battery state is reached, the system will switch its settings to a lower energy setting. The patient can be notified or warned about this by a notification to a patient programmer, the device buzzing, or sending an audible tone to make the patient aware that their battery is low and that the therapy has switched to an energy saving mode.
  • the stimulation therapy could be changed in several ways.
  • the stimulation therapy could add cycling or change the existing cycling time so that the cycle off time becomes longer to save energy.
  • the frequency parameters can be lowered to save energy.
  • the stimulation therapy can decrease the number of programs used in a group, from initially using several programs and potentially using only one.
  • the stimulation therapy can also turn off any sensing to save energy.
  • the stimulation therapy can further lower amplitude or pulse width settings or change electrodes.
  • the stimulation therapy may go back to its original settings automatically, or it may tell the patient that the settings can go back to the original settings and have the patient acknowledge that they want it to change the stimulation therapy to the original settings.
  • the systems and methods provided in the present disclosure can help mitigate the risks or dangers of certain patients (such as, for example, deep brain stimulation patients) losing therapy, which can be severe in some instances where losing therapy can cause a life-threatening situation.
  • patients undergoing therapy to manage chronic pain stretching the cycling time to lengthen the therapy time before depletion may have very little short term impact and provide the patient with ample therapy until they can recharge.
  • Embodiments of the present disclosure beneficially enable adjusting a neuromodulation system to a lower powered state when a battery level of a battery of the system meets or is below a predetermined battery threshold level.
  • Embodiments of the present disclosure also beneficially enable dynamically adjusting the neuromodulation system to different lower powered states when the battery level of the battery meets or is below different predetermined battery threshold levels.
  • Embodiments of the present disclosure further beneficially improve patient comfort by adjusting the settings so as to prolong battery capacity of the battery of the system and provide some level of neuromodulation at a lower battery state.
  • the system 100 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.
  • the system 100 may include at least a device 102 (which may be, for example, a close-loop or open spinal cord stimulation, deep brain stimulation, etc.) that is capable of providing a stimulation to a target anatomical element.
  • the target anatomical element is a spinal cord 108 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.
  • the device 102 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 102 may be configured to generate a current or electrical signal that is delivered to the target anatomical element. Additionally, the system 100 may include one or more leads 104 (e.g., electrical leads) that provide a connection between the device 102 and the spinal cord or nerves of the patient for enabling, for example, stimulation. In some embodiments, the leads 104 may be implanted wholly or partially within the patient. The leads 104 may be, for example, paddle leads and/or percutaneous leads.
  • leads 104 e.g., electrical leads
  • Neuromodulation or neurostimulation techniques may be used for assisting in treatments for different diseases, disorders, or ailments (e.g., chronic pain) of a patient.
  • neuromodulation techniques may be used to relieve chronic pain.
  • 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.
  • the device 102 may provide electrical stimulation of the target anatomical element of the patient (or one or more nerves therein) to relieve chronic pain.
  • the one or more leads 104 may include a first lead 104A that is implanted in a position to provide therapy to a first side of the spinal cord 108 of the patient and a second lead 104B implanted to provide therapy to a second side of the spinal cord 108 of the patient.
  • the first lead 104A may be be implanted in the epidural space above the right side of the spinal cord of the spinal cord 108
  • the second lead 104B may be implanted in the epidural space above the left side side of the spinal cord 108.
  • each lead relative to the spinal cord 108 may vary depending on, for example, the type of treatment, the type of lead, combinations thereof, and the like.
  • the first lead 104A and the second lead 104B may overlap one another, and may be placed proximate one another on the dorsal side of the spinal cord 108 close to a midline of the spinal cord 108.
  • the first lead 104A and the second lead 104B may both be placed above the midline of the spinal cord 108, where one of the leads 104 is cranial (e.g., anterior or nearer the head of the patient) and the other of the leads 104 is caudal (e.g., posterior or nearer the tail of the patient).
  • the first lead 104A and the second lead 104B may both be placed on one side of the midline of the spinal cord 108.
  • the one or more leads 104 may include at least the first lead 104A and the second lead 104B 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.
  • the first lead 104A 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 104B 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 104A and/or the second lead 104B may be configured to provide an electrical stimulation signal from the device 102 to the respective first and/or second vagal trunk.
  • the connection of the leads 104 to the respective vagal trunk (or other nerves) of the patient may permit the device 102 to measure and/or provide one or more stimulations in the patient based on the provided electrical stimulation from the device 102.
  • Fig. 2 depicts the device 102 and the leads 104 connected to the spinal cord 108 of the patient, the leads 104 including one or more electrodes 208, 210 that receive a current or other stimulant instructions from the device 102 (e.g., via the leads 104).
  • the electrodes 208, 210 may each include a body and a plurality of electrodes 208A-208D, 210A- 210D that are disposed on respective first and second sides 204A, 204B of the spinal cord 108, where the plurality of electrodes 208A-208D, 210A-210D are configured to apply the current generated by the device 102 to the spinal cord 108.
  • the leads 104 may include any number of electrodes.
  • a first electrode 208 may be configured for placement on the spinal cord 108 to apply a current to the spinal cord 108 (e.g., carried via a first lead 104A and emitted from one or more of the electrodes 208A-208D), and a second electrode 210 may also be configured for placement on the spinal cord 108 to apply a current to the spinal cord (e.g., carried via a second lead 104B and emitted from one or more of the electrodes 210A-210D).
  • the electrodes 208, 210 may be referred to as cuff electrodes.
  • the system 100 or similar systems may be used, for example, to carry out one or more aspects of the methods 400, 500, or 600 described herein.
  • the system 100 or similar systems may also be used for other purposes.
  • 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.).
  • the use of the leads 104 to stimulate a target anatomical element may occur with different portions of the nervous system.
  • the leads 104 may be connected to one or more of nerve endings in the spinal cord, the brain or portions thereof, combinations thereof, and the like.
  • the system 100 may include one or more batteries 312 (shown in Fig. 3). More specifically, the device 102 may include the battery 312 so as to power the device 102.
  • the battery 312 may be rechargeable. A battery level of the battery may be monitored and one or more settings of the system 100 and/or device 102 may be adjusted when the battery level is at or is less than a predetermined battery level threshold. Conventionally, the battery 312 may become quickly depleted if the system 100 and/or the device 102 are operated at full capacity and the system 100 and/or the device 102 shuts down. This may result in the patient’s loss of neuromodulation therapy, which can be debilitating and, in some cases, lifethreatening, to the patient.
  • patients using deep brain stimulation may be at risk of dystonia if the system 100 ceases to provide neuromodulation therapies.
  • the capacity of the battery - and thus, the system 100 and/or device 102 - may be extended to provide additional time for a user to charge the battery 312 so as to prevent the system 100 and/or the device 102 from completely shutting down.
  • the system 100 may include one or more processors (e.g., one or more DSPs, general purpose microprocessors, graphics processing units, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry) shown and described in Fig. 3 that are programmed to carry out one or more aspects of the present disclosure.
  • the one or more processors may include a memory or may be otherwise configured to perform the aspects of the present disclosure.
  • the one or more processors may provide instructions to the device 102 or other components of the system 100 not explicitly shown or described with reference to Fig.
  • the one or more processors may be part of the device 102 or part of a control unit for the system 100 (e.g., where the control unit is in communication with the device 102 and/or other components of the system 100).
  • the computing device 302 of the system 300 is illustrated as being in communication with the system 100, it is to be understood that the computing device 302 may be disposed as a sub-component within the system 100, or may alternatively be an external device that communicates with the system 100 using, for example, a communication interface 308, or through the cloud 334 or other network.
  • the system 100 may include any one or more components of the system 300 including, but not limited to, the computing device 302, the processor 304, the memory 306, the communication interface 308, the database 330, combinations thereof, and the like.
  • the system 100 includes the device 102, the leads 104, the electrodes 208, 210, the battery 312, at least one battery monitor 314, and the sensor(s) 316.
  • the device 102 may generate a current and the leads 104 and the electrodes 208, 210 may be configured to apply the current to an anatomical element (e.g., the spinal cord, one or more nerves, etc.).
  • the system 100 may communicate with the computing device 302 to receive instructions such as instructions for applying a current to the anatomical element.
  • the system 100 may also provide data (such as data received from or measured by the electrodes 208, 210 and/or measured by the sensors 316 and/or the battery monitor 314), which may be used to calibrate and/or control the device 102.
  • the system 100 includes the battery 312, which may be integrated with, for example, the device 102 or may be a component separate from the device 102. It will be appreciated that the system 100 may include one or more batteries 312.
  • the battery may be configured to provide power to the system 100 so that the device 102 can generate a current for delivery to a target anatomical element.
  • the battery 312 may be any battery capable of providing power to the system 100 and/or the device 102.
  • the battery 312 may also be rechargeable.
  • the battery monitor 314 may be configured to measure one or more values of the battery 312 that can be processed to obtain a battery level of the battery.
  • the battery monitor 314 is a coulomb counter, which can measure the electric charge entering and leaving the battery system that can be used to obtain information corresponding to the battery level of the battery 312.
  • the battery monitor 314 may be any device or apparatus capable of providing information corresponding to the battery level such as, for example, a voltmeter or a multimeter. Data from the battery monitor 314 may be processed by, for example, the processor 304 using a data processing 322 to obtain a battery level of the battery 312.
  • the battery level may be monitored and one or more settings of the system 100 and/or the device 102 may be adjusted based on the battery level. More specifically, the one or more settings may be adjusted at one or more different predetermined battery level threshold(s). In other words, the one or more settings may be adjusted based on one predetermined battery level threshold or may be dynamically adjusted based on more than one predetermined battery level threshold.
  • the sensor(s) 316 may be configured to measure one or more characteristics of the patient such as, for example, heart rate, respiratory rate, patient movement, patient posture, etc. Then sensor 316 may be used to provide feedback in, for example, a closed-loop stimulation system.
  • the sensor 316 may be an integral component of the system 100 or may be a component separate from the system 100.
  • the sensor 316 can include one sensor, two sensors, or more than two sensors.
  • the sensor may comprise, for example, a position sensor, a proximity sensor, a magnetometer, an accelerometer, a linear encoder, a rotary encoder, an image sensor, or an incremental encoder.
  • the computing device 302 comprises a processor 304, a memory 306, a communication interface 308, and a user interface 310.
  • Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 302.
  • the processor 304 of the computing device 302 may be any processor described herein or any similar processor.
  • the processor 304 may be configured to execute instructions stored in the memory 306, which instructions may cause the processor 304 to carry out one or more computing steps utilizing or based on data received from the device 102, the database 330, and/or the cloud network 334.
  • the memory 306 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and/or instructions.
  • the memory 306 may store information or data useful for completing, for example, one or more steps of the methods 400, 500, or 600 described herein, or of any other methods.
  • the memory 306 may store, for example, instructions and/or machine learning models (e.g., neural networks) that support one or more functions of the device 102.
  • the memory 306 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 304, enable the data processing 322 and/or the setting adjustment(s) 324.
  • the data processing 322 enables the processor 104 to process data received from, for example, a battery monitor such as the battery monitor 314.
  • the data may be processed to obtain, for example, a battery level of a battery such as the battery 312.
  • Such information may be used to determine when to adjust one or more settings of the system 100 and/or the device 102 to extend the remaining capacity of the battery based on the battery level.
  • the setting adjustment(s) 324 enables the processor 304 to control or adjust one or more settings related to the system 100 and/or the device 102.
  • the one or more settings may be adjusted based on the battery level processed by the data processing 322.
  • the battery level obtained from the data processing 322 may indicate that the battery level is low and thus, the one or more settings may be adjusted to extend the remaining capacity of the battery 312 and thus, the system 100 and/or the device 102.
  • the setting adjustment(s) 324 may enable the processor 104 to adjust the one or more settings to disable one or more components of the system 100 and/or the device 102 or adjust one or more settings to reduce power usage of the battery 312.
  • the setting adjustments(s) 324 may also enable the processor 304 to readjust the one or more settings to initial values when the battery level is sufficient for optimal operation of the system 100 and/or the device 102, as will be described in more detail in Figs. 4 and 5.
  • Content stored in the memory 306, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines.
  • the memory 306 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 304 to carry out the various method and features described herein.
  • the memory 306 may store one or more settings of the device 104 and/or one or more predetermined thresholds which may be used to, for example, determine which sets of data to use to adjust the one or more settings.
  • memory 306 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models.
  • the data, algorithms, and/or instructions may cause the processor 304 to manipulate data stored in the memory 306 and/or received from or via the device 102, the database 330, and/or the cloud network 334.
  • the computing device 302 may also comprise a communication interface 308.
  • the communication interface 308 may be used for receiving data (for example, data from the device 102) or other information from an external source (such as the device 102, the database 330, the cloud network 334, and/or any other system or component not part of the system 300), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 302, the device 102, the database 330, the cloud network 334, and/or any other system or component not part of the system 300).
  • data for example, data from the device 102
  • an external source such as the device 102, the database 330, the cloud network 334, and/or any other system or component not part of the system 300
  • an external system or device e.g., another computing device 302, the device 102, the database 330, the cloud network 334, and/or any other system or component not part of the system 300.
  • the communication interface 308 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 602.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth).
  • the communication interface 308 may be useful for enabling the computing device 302 to communicate with one or more other processors 304 or computing devices 302, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
  • the computing device 302 may also comprise one or more user interfaces 310.
  • the user interface 310 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 310 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 300 (e.g., by the processor 304 or another component of the system 300) or received by the system 300 from a source external to the system 300.
  • the user interface 310 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 304 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 310 or corresponding thereto.
  • the computing device 302 may utilize a user interface 310 that is housed separately from one or more remaining components of the computing device 302.
  • the user interface 310 may be located proximate one or more other components of the computing device 302, while in other embodiments, the user interface 310 may be located remotely from one or more other components of the computing device 302.
  • the database 330 may store information such as patient data, lead parameters, local field potential (LFP) waveform data or similar data that can include measurements of the body or measurements of the body’s response to treatment, electrode parameters, threshold values, distance values, etc.
  • the database 330 may be configured to provide any such information to the computing device 302 or to any other device of the system 300 or external to the system 300, whether directly or via the cloud network 334.
  • the database 330 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.
  • PACS picture archiving and communication system
  • HIS health information system
  • the cloud network 334 may be or represent the Internet or any other wide area network.
  • the computing device 302 may be connected to the cloud network 334 via the communication interface 308, using a wired connection, a wireless connection, or both.
  • the computing device 302 may communicate with the database 330 and/or an external device (e.g., a computing device) via the cloud network 334.
  • the system 300 or similar systems may be used, for example, to carry out one or more aspects of the methods 400, 500, and/or 600 described herein.
  • the system 300 or similar systems may also be used for other purposes.
  • Fig. 4 depicts a method 400 that may be used, for example, to monitor a battery such as the battery 312 of a neuromodulation system such as the 100 and adjust the system 100 based on a battery level of the battery 312.
  • One or more steps of the method 400 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) 304 of the computing device 302 described above.
  • the at least one processor may be part of the system 100 and more specifically, part of a device (such as a device 102).
  • a processor other than any processor described herein may also be used to execute the method 400.
  • the at least one processor may perform steps of the method 400 by executing elements stored in a memory such as the memory 306.
  • the elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 400.
  • One or more portions of a method 400 may be performed by the processor executing any of the contents of memory, such as data processing 322 and/or setting adjusting 324.
  • the method 400 comprises monitoring a battery level of a battery (step 404).
  • the battery may be the same as or similar to the battery 312 of a neuromodulation system such as the system 100.
  • the battery 312 may power the system and, more specifically, a device such as the device 102 of the system to provide stimulation to a target anatomical element.
  • the battery level may be monitored continuously and/or may be monitored through any of the steps 408-424. In other words, when steps such as 408 (adjusting one or more setting s), 416 (readjusting the one or more settings), or any other step, the battery level may be continued to be monitored throughout and/or after these steps.
  • the battery level may be obtained from, for example, a battery monitor such as the battery monitor 314.
  • the battery monitor may be configured to measure one or more values of the battery that can be processed to obtain a battery level of the battery.
  • the battery monitor is a coulomb counter, which can measure an electric charge entering and leaving the battery system that can be used to provide information corresponding to the battery level of the battery.
  • the battery monitor may be any device or apparatus capable of providing information corresponding to the battery level such as, for example, a voltmeter or multimeter.
  • Data from the battery monitor may be processed by, for example, a processor such the processor 304 using a data processing such as the data processing 322 to obtain a battery level of the battery.
  • the method 400 also comprises adjusting one or more settings of the system or the device (step 408).
  • the one or more settings may be adjusted automatically by a processor such as the processor 304 using a setting adjustment such as the setting adjustment(s) 324.
  • the one or more settings may be adjusted based on user input. For example, a user may select one adjusted setting of a plurality of adjusted settings. In such examples, the user may select to turn off sensing, slow down the microprocessor, put it to sleep more, lowering telemetry power, or adjust one or more settings (e.g., reduce a duration of stimulation, a frequency of stimulation, etc.).
  • Adjusting the one or more settings may include turning off one or more components of the system or device. In some embodiments at least one setting of the one or more settings may be adjusted. In other embodiments each setting of the one or more settings may be adjusted.
  • the one or more settings may include changing a closed-loop neuromodulation to an open-loop neuromodulation, switching from using several programs in a group to using less programs, potentially as low as one, lowering amplitude settings, changing electrodes, etc. or adjusting one or more parameters such as, for example, lowering the frequency parameter(s), adding cycling or changing the existing cycling time, adjusting an off-time cycling, adjusting a pulse width (e.g., reducing or lowering the pulse width by a value or a percentage).
  • the one or more settings may be adjusted based on the battery level monitored in the step 404. More specifically, the one or more settings may be adjusted when the battery level meets or is below a predetermined battery level threshold.
  • the predetermined battery level threshold may be set by a user such as, for example, a medical provider or may be automatically determined automatically using artificial intelligence and training data (e.g., historical cases) in some embodiments.
  • the predetermined battery level may correspond to a battery level at which it is beneficial to reduce a power usage from the battery of the system so as to prolong the remaining batery capacity and increase a window of time for the user to recharge the system.
  • the predetermined battery level threshold may be, for example, 10%, 20%, or 30% of the batery life of a primary batery or 10%, 20%, or 30% of battery capacity for a rechargeable battery. It will be appreciated that in other embodiments the predetermined battery level threshold may be any percentage or value of the batery capacity of the battery.
  • the method 400 also comprises generating a notification (step 412).
  • the notification may be a visual notification, an audible notification, a tactile notification, or any type of notification communicated to a user.
  • the notification may be communicated to the user via a user interface such as the user interface 110.
  • the notification may be automatically generated by the processor.
  • the notification may be automatically generated by any component of a system such as the system 100 or the system 300.
  • the notification may be generated when the monitored batery level meets or is below the predetermined battery level threshold.
  • the notification may indicate to a user such as the patient that the battery level of the batery is at or below the predetermined batery level threshold.
  • the notification may indicate to the user that the battery level is at 20% of battery capacity of the batery. This may further indicate to the user that the user has a set amount of time or working hours left to charge the batery before the batery reaches 0% of battery capacity.
  • the notification may further indicate that the one or more setings have been adjusting accordingly.
  • the notification could also repeat periodically until the user acknowledges that they have received the notification or until the battery has charged to the point that the low batery condition no longer exists and therapy has been restored to its original settings.
  • the step 412 may occur prior to the step 408.
  • the notification may alert a user that the one or more settings of the neuromodulation system or device may about to be adjusted.
  • Such notification may allow the user to cancel the pending change(s) if the user knows, for example, that they will be charging the device soon and will not need the therapy to change (and thus, allow the therapy to run longer at full capacity).
  • the notification may also allow the user to cancel the pending change(s) in case the user needs the performance of the therapy provided by the device as its current settings, as the patient may, for example, potentially not be able to accomplish a physical activity if the therapy changes.
  • the step 412 may occur simultaneously with the step 408.
  • the method 400 also comprises readjusting the one or more settings of the system (step 416).
  • the step 416 is similar to the step 408 described above except that the one or more settings may be readjusted when the battery level meets or exceeds the predetermined battery level threshold, indicating that the battery has been recharged.
  • the one or more settings may be readjusted to a set of initial values programmed when the battery level was above the predetermined battery level threshold levels. For example, the initial values may have been programmed when the battery was at full power or near 100% of the battery level.
  • the method 400 also comprises generating another notification (step 420).
  • the step 420 may be the same as or similar to the step 412 described above except that the notification is generated when the battery level meets or exceeds the predetermined battery level threshold.
  • the notification may indicate to the user that the one or more settings of the system have been readjusted for full operation of the system.
  • step 420 may occur simultaneously with the step 416.
  • the method 400 also comprises reducing power used or powering down one or more sensors or sensing circuits (step 424).
  • the neuromodulation system may include one or more sensors such as the sensors 316.
  • the sensor(s) may be configured to measure one or more characteristics of the patient such as, for example, heart rate, respiratory rate, electrical activity in the body such as, but not limited to, local field potentials (LFPs) and muscle contractions detected through electromyography (EMG), patient movement, patient posture, etc.
  • LFPs local field potentials
  • EMG electromyography
  • the sensor may be used to provide feedback to the system in a closed-loop neuromodulation system.
  • the sensor may be an integral component of the system or may be a component separate from the system.
  • the sensor can include one sensor, two sensors, or more than two sensors.
  • the sensor may comprise, for example, a position sensor, a proximity sensor, a magnetometer, an accelerometer, a linear encoder, a rotary encoder, an image sensor, or an incremental encoder
  • the sensor(s) may be powered down or adjusted so as to reduce power usage when the battery level meets or is below the predetermined battery level threshold.
  • the sensors may be turned off, or data may no longer be transmitted from the sensors.
  • the method 400 may not include the step 424.
  • the step 424 may occur simultaneously or prior to step(s) 408 and/or 412.
  • the method 400 or any step(s) of the method 400 may repeat.
  • the steps 404-420 may repeat as the patient or user uses the neuromodulation system and does not recharge the system until the predetermined battery level threshold is met.
  • the present disclosure encompasses embodiments of the method 400 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
  • Fig. 5 depicts a method 500 that may be used, for example, to monitor a battery such as the battery 312 of a neuromodulation system such as the 100 and adjust the system 100 based on a battery level of the battery 312.
  • One or more steps of the method 500 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) 304 of the computing device 302 described above.
  • the at least one processor may be part of the system 100 or more specifically, a device (such as a device 102).
  • a processor other than any processor described herein may also be used to execute the method 500.
  • the at least one processor may perform steps of the method 500 by executing elements stored in a memory such as the memory 306.
  • the elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 500.
  • One or more portions of a method 500 may be performed by the processor executing any of the contents of memory, such as data processing 322 and/or setting adjusting 324.
  • the method 500 comprises monitoring a battery level of a battery (step 504).
  • the step 504 may be the same as or similar to the step 404 of the method 400 described above.
  • the method 500 also comprises adjusting one or more settings of the system and/or the device based on a first predetermined battery level threshold (step 508).
  • the step 508 may be the same as or similar to the step 408 of the method 400 described above, except that the one or more settings may be adjusted to one or more corresponding first values when the battery level meets or is below the first predetermined battery level threshold.
  • the method 500 also comprises adjusting one or more settings of the system and/or the device based on a second predetermined battery level threshold (step 512).
  • the second predetermined battery level threshold may be less than the first predetermined battery level threshold.
  • the step 520 may be similar to the step 408 of the method 400 described above, except that the one or more settings may be adjusted to one or more corresponding second values.
  • the one or more corresponding second values may be less than the one or more corresponding first values.
  • the one or more settings may be adjusted such that some components are disabled in the step 504 and additional components are disabled in the step 512.
  • the method 500 also comprises readjusting the one or more settings of the system and/or the device based on the second predetermined battery level threshold (step 516).
  • the step 516 may be the same as or similar to the step 416 of the method 400 described above, except that the one or more settings may be readjusted to a value less than the set of initial values programmed when the battery level of the battery is at or above the second predetermined battery level threshold.
  • the method 500 also comprises readjusting the one or more settings of the system and/or the device based on the first predetermined battery level threshold (step 520).
  • the step 520 may be similar to the step 416 of the method 400 described above except that the one or more settings of the system are set to the initial values when the battery level threshold is at or above the first predetermined battery level threshold.
  • the steps 508-520 enable adjustment of the neuromodulation system based on a dynamic range of battery levels such that the neuromodulation therapy can be adjusted so as result in a lower amount of changes to the therapy provided to the patient.
  • the method 500 or any step(s) of the method 500 may repeat.
  • the steps 504-520 may repeat as the patient or user uses the neuromodulation system and does not recharge the system until the first predetermined battery level threshold is met.
  • the steps 508 and 520 may repeat if the patient or user recharges the battery before the battery level is below the second predetermined battery level threshold.
  • the neuromodulation system may include any number of predetermined battery level thresholds.
  • the predetermined battery level thresholds may include one predetermined battery level threshold, two predetermined battery level thresholds, or more than two predetermined battery level thresholds at which the one or more settings are corresponding adjusted at each different level(s).
  • the method 500 also comprises generating a notification (step 524).
  • the step 512 may be the same as or similar to the step 412 of the method 400 described above and can be executed after any of the steps 508, 512, 516, and/or 520.
  • the present disclosure encompasses embodiments of the method 500 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
  • Fig. 6 depicts a method 600 that may be used, for example, to monitor a battery such as the battery 312 of a neuromodulation system such as the 100 and adjust the system 100 based on a battery level of the battery 312.
  • One or more steps of the method 600 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) 304 of the computing device 302 described above.
  • the at least one processor may be part of the system 100 or more specifically, a device (such as a device 102).
  • a processor other than any processor described herein may also be used to execute the method 600.
  • the at least one processor may perform steps of the method 600 by executing elements stored in a memory such as the memory 306.
  • the elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 600.
  • One or more portions of a method 600 may be performed by the processor executing any of the contents of memory, such as data processing 322 and/or setting adjusting 324.
  • the method 600 comprises monitoring a duration of time from an initial charge of the battery (step 604).
  • Monitoring the duration of the battery usage from the initial charge of the battery may include measuring a time duration of battery usage from the initial charge of the battery.
  • a timer may track the amount of time that has passed since the initial charge of the battery.
  • the method 600 also comprises adjusting one or more settings of the system and/or the device based on the duration (step 608).
  • the step 608 may be the same as or similar to the step 408 of the method 400 described above, except that the one or more settings may be adjusted when the duration of time has met or exceeded a predetermined duration of time threshold.
  • the predetermined duration of time threshold may correspond to a duration of time from when the battery was initially charged to a time at which it is beneficial to adjust one or more settings of the neuromodulation system to prolong the remaining battery capacity of the battery.
  • the predetermined duration of time threshold may be determined based on, for example, historical duration of time(s) and/or user input.
  • the method 600 also comprises generating a notification (step 612).
  • the step 612 may be the same as or similar to the step 412 of the method 400 described above, except that that the notification is generated when the duration of time has met or exceeded the predetermined duration of time threshold.
  • the method 600 also comprises readjusting the one or more settings of the system and/or the device when the duration is reset (step 616).
  • the step 616 may be the same as or similar to the step 416 of the method 400 described above, except that the one or more settings of the system may be readjusted to the set of initial values when the duration of time is reset.
  • the duration of time may be reset when the battery is recharged to an initial value (e.g., at or near 100% battery capacity of the battery, at or near 90% of the battery capacity of the battery, etc.).
  • the present disclosure encompasses embodiments of the method 600 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
  • Monitoring of a battery level of a battery or a duration of use of a battery of a neuromodulation system and adjusting one or more settings of the neuromodulation system based on the battery level as described in the methods 400, 500, and 600 above beneficially prevent the neuromodulation system from prematurely shutting down or failing to provide neuromodulation therapies to a patient, which may be potentially dangerous to a patient.
  • the systems and methods described in the present disclosure enable adjustments to the neuromodulation system to prolong or extend a remaining capacity of the battery such that the patient has more time to recharge the battery of the neuromodulation system.
  • recharging of the battery may result in the neuromodulation system being restored to its initial settings or to at least a proportion of the initial settings.
  • Example 1 A system, comprising: a neuromodulation system configured to generate and deliver stimulation to a target anatomical region, the neuromodulation system having a battery to power the neuromodulation system; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor a battery level of the battery; adjust one or more settings of the neuromodulation system when the battery level meets or is below a predetermined battery level threshold.
  • Example 2 The system of example 1, wherein the data further causes the processor to: generate a notification when the battery level meets or is below the predetermined battery threshold level, readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds the predetermined battery level threshold, wherein the one or more settings are readjusted to a set of initial values programmed when the battery level is above the predetermined battery level threshold level.
  • Example 3 The system of example 2, wherein the data further causes the processor to: generate another notification when the one or more settings are readjusted to the set of initial values.
  • Example 4 The system of example 1, wherein the predetermined threshold is a first predetermined threshold, and wherein the data further causes the processor to: readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds a second predetermined battery level threshold less than the first predetermined battery level threshold, and readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds the first predetermined battery level threshold.
  • the predetermined threshold is a first predetermined threshold
  • the data further causes the processor to: readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds a second predetermined battery level threshold less than the first predetermined battery level threshold, and readjust the one or more settings of the neuromodulation system when the battery level meets or exceeds the first predetermined battery level threshold.
  • Example 6 The system of example 1, wherein adjusting the one or more settings includes changing a value of at least one setting of the one or more settings.
  • Example 7 The system of example 6, wherein adjusting the one or more settings comprises at least one of lowering frequency parameter(s), adding cycling or changing the existing cycling time, adjusting an off-time cycling, adjusting a pulse width, changing a closed- loop neuromodulation to an open-loop neuromodulation, switching from using several groups in a program to only one, lowering amplitude settings, or changing electrodes.
  • Example 8 The system of example 1, wherein the notification includes information about at least one of a remaining battery level or working hours left of the neuromodulation device.
  • Example 9 The system of example 1, wherein the one or more settings comprises one or more stimulation parameters.
  • Example 10 The system of example 1, further comprising one or more sensors configured to sense at least one characteristic of the neuromodulation system, and wherein the data further causes the processor to: at least one of reduce power used or power down the one or more sensors when the battery level meets or is below the predetermined battery threshold level.
  • Example 11 The system of example 1 , wherein the predetermined battery level threshold is between about 10% and about 30% of a battery capacity of the battery.
  • Example 12 The system of example 1, wherein the neuromodulation system includes a device configured to generate a stimulation and a lead configured to deliver the stimulation to a target anatomical region.
  • Example 13 The system of example 1, further comprising a coulomb counter configured to measure the battery level.
  • Example 14 A system, comprising: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region; a battery to power the device; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor a battery level of the battery; adjust one or more settings of the device when the battery level meets or is below a predetermined battery level threshold; and generate a notification when the battery level meets or is below the predetermined battery threshold level.
  • Example 15 The system of example 14, wherein the data further causes the processor to: readjust the one or more settings of the device when the battery level meets or exceeds the predetermined battery level threshold, wherein the one or more settings are changed to a set of initial values programmed when the battery level is above the predetermined battery level threshold level.
  • Example 16 The system of example 15, wherein the data further causes the processor to: generate another notification when the one or more settings are changed to the set of initial values.
  • Example 17 The system of Example 14, further comprising one or more sensors configured to sense at least one characteristic of the device, and wherein the data further causes the processor to: at least one of reduce power used or power down the one or more sensors when the battery level meets or is below the predetermined battery threshold level.
  • Examplel8 The system of example 14, wherein the predetermined battery level threshold is between about 10% and about 30% of a battery capacity of the battery.
  • Example 19 A system, comprising: a device configured to generate a stimulation; a lead configured to deliver the stimulation to a target anatomical region; a battery to power the device; a battery monitor configured to monitor a battery level of the battery; a processor; and a memory capable of storing data thereon that, when processed by the processor, cause the processor to: monitor, using the batter monitor, a battery level of the battery; adjust one or more settings of the device when the battery level meets or is below a predetermined battery level threshold; and generate a notification when the battery level meets or is below the predetermined battery threshold level.
  • Example 20 The system of example 19, wherein the battery monitor comprises a coulomb counter.

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Abstract

L'invention concerne des systèmes et des procédés de réglage d'un système de neuromodulation sur la base d'un niveau de batterie de système. L'invention concerne un système de neuromodulation configuré pour générer et administrer une stimulation à une région anatomique cible. Le système de neuromodulation comprend une batterie destinée à alimenter le système de neuromodulation. Un niveau de batterie de la batterie peut être surveillé et un ou plusieurs réglages du système de neuromodulation peuvent être ajustés lorsque le niveau de batterie satisfait ou est inférieur à un seuil de niveau de batterie prédéterminé.
PCT/IB2024/058087 2023-08-30 2024-08-20 Systèmes et procédés de réglage d'un système de neuromodulation sur la base d'un niveau de batterie de système Pending WO2025046392A1 (fr)

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US20140277267A1 (en) * 2013-03-15 2014-09-18 Boston Scientific Neuromodulation Corporation Neuromodulation system and method for transitioning between programming modes
EP2667942B1 (fr) * 2011-01-28 2019-10-23 Micron Devices LLC Système stimulateur neuronal
WO2021126606A1 (fr) * 2019-12-20 2021-06-24 Medtronic, Inc. Dispositif médical et procédé d'estimation du temps entre des niveaux de tension d'une source d'alimentation
US20220266041A1 (en) * 2021-02-24 2022-08-25 Medtronic, Inc. Medical device patient alert using housing stimulation based on sensed event
US20220401739A1 (en) * 2021-06-21 2022-12-22 Boston Scientific Neuromodulation Corporation Cloud-based sensor operation adapted to patient behavior

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Publication number Priority date Publication date Assignee Title
EP2667942B1 (fr) * 2011-01-28 2019-10-23 Micron Devices LLC Système stimulateur neuronal
US20140277267A1 (en) * 2013-03-15 2014-09-18 Boston Scientific Neuromodulation Corporation Neuromodulation system and method for transitioning between programming modes
WO2021126606A1 (fr) * 2019-12-20 2021-06-24 Medtronic, Inc. Dispositif médical et procédé d'estimation du temps entre des niveaux de tension d'une source d'alimentation
US20220266041A1 (en) * 2021-02-24 2022-08-25 Medtronic, Inc. Medical device patient alert using housing stimulation based on sensed event
US20220401739A1 (en) * 2021-06-21 2022-12-22 Boston Scientific Neuromodulation Corporation Cloud-based sensor operation adapted to patient behavior

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