EP-4735106-A1 - STIMULATION DEVICE

EP4735106A1EP 4735106 A1EP4735106 A1EP 4735106A1EP-4735106-A1

Abstract

The present invention is concerned with a stimulation device that comprises: an airway opener configured to be positioned around a user's neck and, once positioned, physically impact the user's airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user's neck, to deliver an electric current to a target area on the user.

Inventors

Valiyambath, Mohankumar Krishnan
Deas, Ross William

Assignees

ResMed Pty Ltd

Dates

Publication Date: 20260506
Application Date: 20240626

Claims (20)

1. A stimulation device comprising: an airway opener configured to be positioned around a user’ s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user.
2. A stimulation device according to claim 1, wherein the stimulator comprises one or more stimulating elements positioned on the airway opener such that once the airway opener is in position around the user’s neck, the one or more stimulating elements, once activated, deliver the electric current to the target area on the user.
3. A stimulation device according to claim 2, wherein activation of selected ones of the one or more of the stimulating elements is controllable to deliver the electric current to a selected target area on the user.
4. A stimulation device according to claim 3, wherein the selected target area comprises branches of a nerve or one or more muscles of the user.
5. A stimulation device according to claim 4, wherein the branches of a nerve of the user are adjacent to the tongue of the user.
6. A stimulation device according to claim 2, wherein the stimulating elements comprise one or more pairs of spaced apart electrodes defining an electric current path therebetween.
7. A stimulation device according to claim 6, wherein the spaced apart electrodes of at least one pair of spaced apart electrodes are substantially coplanar in a horizontal plane passing through the user’s neck.
8. A stimulation device according to claim 6, wherein the spaced apart electrodes of at least one pair of spaced apart electrodes are located on different horizontal planes passing through the user’s neck.
9. A stimulation device according to claim 3, wherein the airway opener is configured to be placed into an airway patency setting selected from a group of two or more airway patency settings, the airway opener, when in an airway patency setting, maintaining the user’s head and/or neck in a specified position to impact the user’s airway patency.
10. A stimulation device according to claim 9, wherein the activation of selected ones of the one or more of the stimulating elements is controllable to account for the airway patency setting in which the airway opener is currently placed.
11. A stimulation device according to claim 9, wherein the airway opener comprises a dimension modifier for changing an axial length of the airway opener along a longitudinal axis, the axial length of the airway opener thereby defining the group of two or more airway patency settings.
12. A stimulation device according to claim 11, wherein the dimension modifier comprises one or more inflation chambers configured to receive an inflation fluid, the inflation fluid once received in the inflation chamber changing the axial length of the airway opener.
13. A stimulation device according to claim 11, wherein the dimension modifier comprises a motor drive configured to move a driven member along a linear path to thereby change the axial length of the airway opener.
14. A stimulation device according to claim 11, wherein the dimension modifier comprises an axial force applying component composed of a shape memory alloy and an elastic component, the axial force applying component and elastic component combining to change the axial length of the airway opener.
15. A stimulation system comprising: a stimulation device according to any one of the preceding claims; a sensor configured to generate respiration data associated with respiration of the user when the stimulation device is positioned around the user’s neck; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine- readable instructions to: receive respiration data from the sensor; generate a respiration signal for the user, the respiration signal based at least in part on the received respiration data; process the respiration signal to identify one or more sleep-related respiratory disorders; and responsive to identifying the one or more sleep-related respiratory disorders, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering or modifying a characteristic of the electric current delivered to the target area on the user.
16. A stimulation system according to claim 15, wherein the control system is further configured to execute the machine readable instructions to: receive subsequent respiration data from the sensor; generate a subsequent respiration signal for the user, the subsequent respiration signal based at least in part on the received subsequent respiration data; process the subsequent respiration signal to determine whether the identified one or more sleep-related respiratory disorders is continuing; and responsive to the determination, causing the stimulation device to either cease, modify or continue the corrective action.
17. A stimulation device according to claim 15, wherein the corrective action further comprises placing the airway opener into a selected airway patency setting that is suitable for treating the identified one or more sleep-related respiratory disorders.
18. A stimulation device according to claim 17, wherein the corrective action further comprises activating selected ones of the one or more stimulating elements to deliver an electric current to a target area of the user associated with the selected airway patency setting.
19. A stimulation device according to claim 17, wherein the corrective action further comprises modifying the electrical characteristics of the electrical current to accord with the selected airway patency setting.
20. A method of treating a user for a sleep-related respiratory disorder, comprising: positioning a stimulation device around the user’s neck, the stimulation device comprising: an airway opener configured to be positioned around a user’s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user; monitoring the user for a sleep-related respiratory disorder; and upon detecting a sleep-related respiratory disorder, causing the stimulation device to apply a corrective action to the user, the corrective action comprising the airway opener physically impacting the user’s airway patency and/or the stimulator delivering the electric current to a selected target area on the user.

Description

STIMULATION DEVICE TECHNICAL FIELD [1] The present disclosure relates generally to devices and methods for treating sleep-related respiratory disorders, and more particularly, to devices and methods for treating sleep-related respiratory disorders through electrical stimulation. BACKGROUND [2] 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 by events 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 supplying 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, with the result that ongoing compliance with CPAP therapy suffers. Other systems rely on a surgically implanted stimulator that stimulates nerves/muscles to open the airway. However, these stimulators must be surgically implanted and thus subject the user to the risks and disadvantages that surgery entails. [3] The present disclosure is directed to providing an alternative solution to addressing sleep- related respiratory disorders. SUMMARY [4] In one aspect, the present disclosure is concerned with a stimulation device comprising: an airway opener configured to be positioned around a user’s neck and, once positioned, physically impact the user’s airway patency; and a stimulator provided on the airway opener, the stimulator configured, once the airway opener is in position around the user’s neck, to deliver an electric current to a target area on the user. [5] The stimulator may comprise one or more stimulating elements positioned on the airway opener such that once the airway opener is in position around the user’s neck, the one or more stimulating elements, once activated, deliver the electrical current to the target area on the user. [6] In some embodiments, activation of selected ones of the one or more of the stimulating elements is controllable to deliver an electric current to a selected target area on the user, such as branches of a nerve of the user or one or more muscles of the user. These branches of a nerve of the user may be adjacent to the tongue of the user. [7] In some embodiments, the stimulating elements comprise one or more pairs of spaced apart electrodes defining an electric current path therebetween. The spaced apart electrodes of at least one pair of spaced apart electrodes may be substantially coplanar in a horizontal plane passing through the user’s neck. The spaced apart electrodes of at least one pair of spaced apart electrodes may also be located on different horizontal planes passing through the user’s neck. [8] The airway opener may be configured to be placed into an airway patency setting selected from a group of two or more airway patency settings, the airway opener, when in an airway patency setting, maintaining the user’s head and/or neck in a specified position to impact the user’s airway patency. [9] The activation of selected ones of the one or more of the stimulating elements is in some cases controllable to account for the airway patency setting in which the airway opener is currently placed. [10] In some embodiments, the airway opener comprises a dimension modifier for changing an axial length of the airway opener along a longitudinal axis, the axial length of the airway opener thereby defining the group of two or more airway patency settings. The dimension modifier may take the form of one or more inflation chambers configured to receive an inflation fluid, the inflation fluid once received in the inflation chamber changing the axial length of the airway opener. Alternatively, the dimension modifier takes the form of a motor drive configured to move a driven member along a linear path to thereby change the axial length of the airway opener. In another embodiment, the dimension modifier takes the form of an axial force applying component composed of a shape memory alloy and an elastic component, the axial force applying component and elastic component combining to change the axial length of the airway opener. [11] The present disclosure also provides a stimulation system comprising: a stimulation device according to the first aspect of the present disclosure; a sensor configured to generate respiration data associated with respiration of the user when the stimulation device is positioned around the user’s neck; a memory storing machine-readable instructions; and a control system including one or more processors configured to execute the machine-readable instructions to: receive respiration data from the sensor; generate a respiration signal for the user, the respiration signal based