EP-4735107-A1 - SYSTEMS AND METHODS FOR AIDING A USER IN BREATHING USING IMPLANTABLE DEVICES

Abstract

A neurostimulation system disclosed herein comprises a stimulation device including a stimulator that is configured to provide electrical stimulation to one or more branches of a nerve of the user or one or more muscles of the user, a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to implement an acclimatization process. The acclimatization process is configured to acclimatize the user to a neurostimulation therapy for aiding the user in breathing, prior to commencement of a therapy period, by: setting a stimulation profile of the system to a starting stimulation profile configured so that a level of electrical stimulation applied under the starting stimulation profile is weaker than required for providing the neurostimulation therapy; causing the stimulation device to provide the electrical stimulation under the starting stimulation profile to the one or more branches of the nerve or the one or more muscles; receiving a response data from, or measured from a physiological output of, the user; processing the response data to determine a stimulation response; changing the stimulation profile to increase a level of electrical stimulation applied under the profile, while the stimulation response is within a tolerance threshold; and stopping stimulation when the stimulation response is not within the tolerance threshold or the stimulation profile is at a predefined limit.

Inventors

• DENT, Michael James
• WELLS, Matthew Robin
• Deas, Ross William

Assignees

• ResMed Pty Ltd

Dates

Publication Date

20260506

Application Date

20240627

Claims (20)

1. 1. A neurostimulation system, comprising: a stimulation device including a stimulator that is configured to provide electrical stimulation to one or more branches of a nerve of the user or one or more muscles of the user; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to implement an acclimatization process to acclimatize the user to a neurostimulation therapy for aiding the user in breathing, prior to commencement of a therapy period, by: setting a stimulation profile of the system to a starting stimulation profile configured so that a level of electrical stimulation applied under the starting stimulation profile is weaker than required for providing the neurostimulation therapy; causing the stimulation device to provide the electrical stimulation under the starting stimulation profile to the one or more branches of the nerve or the one or more muscles; receiving a response data from, or measured from a physiological output of, the user; processing the response data to determine a stimulation response; changing the stimulation profile to increase a level of electrical stimulation applied under the profile, while the stimulation response is within a tolerance threshold; and stopping stimulation when the stimulation response is not within the tolerance threshold or the stimulation profile is at a predefined limit.
2. 2. The system of claim 1, wherein the stimulation profile is characterized by one or more parameters, and the electrical stimulation strength associated with the stimulation profile is determined at least in part by values of the one or more parameters.
3. 3. The system of claim 2, wherein the plurality of parameters comprise parameters selected from: an amplitude, a frequency, and a duty cycle of the stimulation.
4. 4. The system of claim 3, wherein changing the stimulation profile comprises increasing the value or values of one or more of the parameters.
5. 5. The system of any one of claims 2 to 4, wherein the parameters comprise one or more nonquantitative parameters selected from; stimulation channel and user position.
6. 6. The system of any preceding claim, wherein the control system is further configured to output a highest level of stimulation which the user is able to tolerate within a tolerance threshold and/or an acclimatized stimulation profile associated with the highest level of stimulation.
7. 7. The system of claim 6, wherein the highest stimulation level and/or the acclimatized stimulation profile is used as a basis to set a therapy stimulation level for the neurostimulation therapy.
8. 8. The system of claim 6 or 7, wherein the user’s tolerance is determined from a threshold framework.
9. 9. The system of any preceding claim, wherein the control system is further configured to output an acclimatized stimulation profile associated with the highest stimulation level.
10. 10. The system of any preceding claim, wherein the control system is further configured to output a period of time which has elapsed from a time when stimulation at a last stimulation level is applied to a time when the response data indicating the stimulation response outside the tolerance threshold is received.
11. 11. The system of any preceding claim, wherein the control system is configured to change the stimulation profile based on a comparison between the stimulation response and the tolerance threshold.
12. 12. The system of any preceding claim, wherein the response data comprises selfreported data provided by the user or a third-party via an external device.
13. 13. The system of claim 12, wherein the self-reported data indicates a pain or discomfort, or pain or discomfort level, experienced by the user during application of electrical stimulation.
14. 14. The system of claim 12 or 13, wherein the response data includes sensor data gathered by one or more sensors.
15. 15. The system of claim 14, comprising one or more sensors configured to do one or more of: measure one or more physiological outputs from the user, measure an acoustic output from the user, acquire a camera or thermal image of the user, sense motion.
16. 16. The system of claim 15, wherein the one or more physiological outputs comprises one or more of: heart rate, breathing rate, a force or strain caused by a muscle twitch, a respiratory flow rate, electrocardiogram, electroencephalogram.
17. 17. The system of any preceding claim, further comprising an output device configured to provide an acoustic, visual, or video output, wherein the control system is configured to cause the output device to provide an additional therapy to the user, the additional therapy being delivered using one or more of an acoustic, visual, or video signals, while causing the stimulation device to provide the electrical stimulation.
18. 18. The system of claim 17, wherein the additional therapy is configured to trigger or aid in triggering a parasympathetic nervous response in the user.
19. 19. The system of claim 17 or 18, wherein the additional therapy is provided in response to the control system determining that user has a negative response to the electrical stimulation wherein the stimulation response is not within the tolerance threshold.
20. 20. The system of any one of claims 17 to 19, wherein the output device is configured to provide additional therapy from a time which precedes a start time when the stimulation provides the electrical stimulation.

Description

SYSTEMS AND METHODS FOR AIDING A USER IN BREATHING USING IMPLANTABLE DEVICES TECHNICAL FIELD [0001] The present disclosure relates generally to systems and methods for aiding a user in breathing, and more particularly, to systems and methods for aiding in preventing an apnea from occurring by stimulating one or more nerve branches at a determined stimulation time. BACKGROUND [0002] Many individuals suffer from sleep-related respiratory disorders such as, for example, Sleep-Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA), Cheyne- Stokes Respiration (CSR). These disorders are characterized event such as apneas, hypopneas, hyperpnea, and hypercapnia where the individual’s breathing stops or is disrupted/restricted during sleep. Various systems exist for aiding users experiencing sleep apnea and related respiratory disorders. Some such systems require the user to wear an interface (e.g., mask) that aids in suppling pressurized air to the airway of the user (e.g., a continuous positive airway pressure (CPAP) system). Some users find such systems to be uncomfortable, difficult to use, expensive, aesthetically unappealing, etc. Other systems rely on an implanted respiration monitoring sensor and/or stimulator that stimulates nerves/muscles to open the airway. In such systems, electrical stimulation provided to the nerves or muscles may cause discomfort to the users, particularly when the user is still awake. The stimulation may also cause the users to awaken from their sleep, when the therapy is performed while the user is asleep, thus defeating the purpose for providing a sleep aid. However, although applying lower stimulation levels decreases the possibility of discomfort to the users or waking the users, this may impact the effectiveness in the therapy in aiding to open the airway. The present disclosure is directed to solving or ameliorating, at least in part, these and other problems. SUMMARY [0003] According to some implementations of the present disclosure, there is provided a neurostimulation system, comprising: a stimulation device including a stimulator that is configured to provide electrical stimulation to one or more branches of a nerve of the user or one or more muscles of the user; a memory storing machine-readable instructions; and a control system including one or more processors. The one or more processors are configured to execute the machine-readable instructions to implement an acclimatization process to acclimatize the user to a neurostimulation therapy for aiding the user in breathing, prior to commencement of a therapy period, by: setting a stimulation profile of the system to a starting stimulation profile configured so that a level of electrical stimulation applied under the starting stimulation profile is weaker than required for providing the neurostimulation therapy; causing the stimulation device to provide the electrical stimulation under the starting stimulation profile to the one or more branches of the nerve or the one or more muscles; receiving a response data from, or measured from a physiological output of, the user; processing the response data to determine a stimulation response; changing the stimulation profile to increase a level of electrical stimulation applied under the profile, while the stimulation response is within a tolerance threshold; and stopping stimulation when the stimulation response is not within the tolerance threshold or the stimulation profile is at a predefined limit. [0004] In some embodiments, the stimulation profile is characterized by one or more parameters, and the electrical stimulation strength associated with the stimulation profile is determined at least in part by values of the one or more parameters. [0005] In some embodiments, the the plurality of parameters comprise parameters selected from: an amplitude, a frequency, and a duty cycle of the stimulation. [0006] In some embodiments, the changing the stimulation profile comprises increasing the value or values of one or more of the parameters. [0007] In some embodiments, the parameters comprise one or more nonquantitative parameters selected from: stimulation channel and user position. [0008] In some embodiments, the control system is further configured to output a highest level of stimulation which the user is able to tolerate within a tolerance threshold and/or an acclimatized stimulation profile associated with the highest level of stimulation. [0009] In some embodiments, the highest stimulation level and/or the acclimatized stimulation profile is used as a basis to set a therapy stimulation level for the neurostimulation therapy. [0010] In some embodiments, the user’s tolerance is determined from a threshold framework. [0011] In some embodiments, the control system is further configured to output an acclimatized stimulation profile associated with the highest stimulation level. [0012] In some embodiments, the control system is further configured to output a period of time wh