Method and system for applying stimulation in treating sleep disordered breathing

• US 10,583,297 B2
• Filed: 01/09/2018
• Issued: 03/10/2020
• Est. Priority Date: 08/11/2011
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Ni, Quan, Christopherson, Mark A., Rondoni, John
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/866,164
• Publication Number:
  US 20190009093A1
• Time in Patent Office: 791 Days
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A stimulation protocol determination system includes an input module and a selector module. The input module is provided to receive an indication of an upper airway flow limitation via sensed respiratory effort information. The selection module is provided to automatically select, based on the indicated upper airway flow limitation, a stimulation protocol.

Claims

1. A stimulation system comprising:

an implantable pulse generator comprising;

a sensing element to receive sensed respiratory effort information;

a stimulation element to apply a stimulation signal to a hypoglossal nerve via a nerve electrode; and

a controller to implement a therapy manager and in communication with at least the sensing element and the stimulation element, wherein the controller comprises a processing resource and a non-transitory computer readable memory storing machine readable instructions, executable via the processing resource, to;

determine, via the therapy manager, an indication of an upper airway flow limitation via the sensed respiratory effort information from the sensing element, wherein the indicated upper airway flow limitation corresponds to at least a partial obstruction of the upper airway flow associated with obstructive sleep apnea; and

determine an obstructive sleep apnea therapy via the therapy manager, via automatically selecting based on the determined indication of the upper airway flow limitation, between at least;

a first nerve stimulation protocol to apply stimulation to the hypoglossal nerve via the stimulation element synchronous with an expiratory phase of a respiratory cycle; and

a second nerve stimulation protocol to apply stimulation to the hypoglossal nerve via the stimulation element during both of a portion of an inspiratory phase of the respiratory cycle and a portion of the expiratory phase,

wherein the instructions are to;

automatically select the first nerve stimulation protocol upon determination, via the therapy manager, that the indicated upper airway flow limitation predominantly coincides with the expiratory phase; and

cause application of nerve stimulation via the stimulation module according to the automatically selected first nerve stimulation protocol.

2. The system of claim 1, wherein the determination of the obstructive sleep apnea therapy comprises automatic selection between the first nerve stimulation protocol, the second nerve stimulation protocol, and a third nerve stimulation protocol to apply stimulation to the hypoglossal nerve synchronous with the inspiratory phase when the flow limitation coincides with the inspiratory phase.

3. The system of claim 1, comprising:

a respiration sensor to sense the respiratory effort information and communicable with at least the sensing element regarding the sensed respiratory effort information.

4. The system of claim 1, comprising:

an implantable nerve cuff electrode connectable to the implantable pulse generator to apply, via the stimulation element of the implantable pulse generator, a respective one of the first and second nerve stimulation protocols.

5. The system of claim 1, wherein the instructions define the portion of the inspiratory phase as including at least an end portion of the inspiratory phase and wherein the instructions define the portion of the expiratory phase as including at least a beginning portion of the expiratory phase.

6. The system of claim 5, wherein the instructions define the portion of the inspiratory phase as excluding a beginning portion of the inspiratory phase.

7. The system of claim 5, wherein the instructions define the portion of the expiratory phase as excluding an end portion of the expiratory phase.

8. The system of claim 5, wherein the second nerve stimulation protocol includes a generally continuous stimulation period applied during at least a portion of at least some respiratory cycles, wherein the generally continuous stimulation period predominantly coincides with the portion of the inspiratory phase and with the portion of the expiratory phase, and

wherein the generally continuous stimulation period includes an initial start point located after a beginning of the inspiratory phase and an initial termination point located prior to an end of the expiratory phase.

9. The system of claim 8, wherein the instructions define the second nerve stimulation protocol as including the application of the generally continuous stimulation period for a set of consecutive respiratory cycles over a first time period and wherein the instructions are to cause:

determination if at least some indications of upper airway flow limitations are received within the first time period;

maintaining or increasing a duration of the generally continuous stimulation period if the at least some indications of upper airway flow limitations are received during the first time period; and

reducing the duration of the generally continuous stimulation period if no upper airway flow indications are received during the first time period.

10. The system of claim 9, wherein the instructions define the first time period as a period, based on an apnea-hypopnea index, for which an apnea would likely occur in the absence of stimulation.

11. The system of claim 9, wherein the instructions are to cause reducing the duration as including at least one of:

decrementally moving the initial start point closer to the end portion of the inspiratory phase for the next set of consecutive respiratory cycles;

decrementally moving the initial termination point closer to the beginning portion of the expiratory phase for the next set of consecutive respiratory cycles.

12. The system of claim 8, wherein instructions define a first portion of the generally continuous stimulation period as coinciding with the portion of the inspiratory phase and has a duration of at least one of:

at least one-third of an entirety of the inspiratory phase;

at least one-half of the entirety of the inspiratory phase; and

at least two-thirds of the entirety of the inspiratory phase.

13. The system of claim 8, wherein instructions define a second portion of the generally continuous stimulation period as coinciding with the portion of the expiratory phase and has a duration of at least one of:

at least one-third of the entirety of the expiratory phase;

at least one-half of the entirety of the expiratory phase; and

at least two-thirds of the entirety of the expiratory phase.

14. The system of claim 5, wherein the instructions define the portion of the inspiratory phase as corresponding to at least a majority of the inspiratory phase and define the portion of the expiratory phase as corresponding to at least a majority of the expiratory phase.

15. The system of claim 14, wherein the majority of the inspiratory phase comprises at least two-thirds of the inspiratory phase and the majority of the expiratory phase comprises at least two-thirds of the expiratory phase.

16. A stimulation system, comprising:

an implantable pulse generator comprising;

a sensing element to receive sensed respiratory effort information;

a stimulation element to apply a stimulation signal to a hypoglossal nerve via a nerve electrode; and

a controller to implement a therapy manager and in communication with at least the sensing element and the stimulation element, wherein the controller comprises a processing resource and a non-transitory computer readable memory storing machine readable instructions, executable via the processing resource, to;

determine, via the therapy manager, an indication of an upper airway flow limitation via the sensed respiratory effort information from the sensing element, wherein the indicated upper airway flow limitation corresponds to at least a partial obstruction of the upper airway flow associated with obstructive sleep apnea; and

determine an obstructive sleep apnea therapy via the therapy manager, via automatically selecting based on the determined indication of the upper airway flow limitation, between at least;

a first nerve stimulation protocol to apply stimulation to the hypoglossal nerve via the stimulation element synchronous with an expiratory phase of a respiratory cycle; and

a second nerve stimulation protocol to apply stimulation to the hypoglossal nerve via the stimulation element during both of a portion of an inspiratory phase of the respiratory cycle and a portion of the expiratory phase,

wherein the instructions are to;

automatically select the second nerve stimulation protocol upon determination, via the therapy manager, that the indicated upper airway flow limitation predominantly coincides with both of a first portion of the inspiratory phase and a first portion of the expiratory phase but does not predominantly coincide with a second portion of inspiratory phase and with a second portion of the expiratory phase; and

cause application of nerve stimulation via the stimulation module according to the automatically selected second nerve stimulation protocol.

17. The system of claim 16, wherein the instructions define the first portion of the inspiratory phase as including at least an end portion of the inspiratory phase and wherein the instructions define the first portion of the expiratory phase as including at least a beginning portion of the expiratory phase.

18. The system of claim 17, wherein the instructions define the first portion of the inspiratory phase as excluding a beginning portion of the inspiratory phase.

19. The system of claim 17, wherein the instructions define the second portion of the expiratory phase as excluding an end portion of the expiratory phase.

20. The system of claim 17, wherein the second nerve stimulation protocol includes a generally continuous stimulation period applied during at least a portion of at least some respiratory cycles, wherein the generally continuous stimulation period predominantly coincides with the first portion of the inspiratory phase and with the first portion of the expiratory phase, and

wherein the generally continuous stimulation period includes an initial start point located after a beginning of the inspiratory phase and an initial termination point located prior to an end of the expiratory phase.

21. The system of claim 20, wherein the instructions define the second nerve stimulation protocol as including the application of the generally continuous stimulation period for a set of consecutive respiratory cycles over a first time period and wherein the instructions are to cause:

determination if at least some indications of upper airway flow limitations are received within the first time period;

maintaining or increasing a duration of the generally continuous stimulation period if the at least some indications of upper airway flow limitations are received during the first time period; and

reducing the duration of the generally continuous stimulation period if no upper airway flow indications are received during the first time period.

22. The system of claim 21, wherein the instructions define the first time period as a period, based on an apnea-hypopnea index, for which an apnea would likely occur in the absence of stimulation.

23. The system of claim 21, wherein the instructions are to cause reducing the duration as including at least one of:

decrementally moving the initial start point closer to the end portion of the inspiratory phase for the next set of consecutive respiratory cycles;

decrementally moving the initial termination point closer to the beginning portion of the expiratory phase for the next set of consecutive respiratory cycles.

24. The system of claim 20, wherein instructions define a first portion of the generally continuous stimulation period as coinciding with the first portion of the inspiratory phase and has a duration of at least one of:

at least one-third of an entirety of the inspiratory phase;

at least one-half of the entirety of the inspiratory phase; and

at least two-thirds of the entirety of the inspiratory phase.

25. The system of claim 20, wherein instructions define a second portion of the generally continuous stimulation period as coinciding with the first portion of the expiratory phase and has a duration of at least one of:

at least one-third of the entirety of the expiratory phase;

at least one-half of the entirety of the expiratory phase; and

at least two-thirds of the entirety of the expiratory phase.

26. The system of claim 17, wherein the instructions define the first portion of the inspiratory phase as corresponding to at least a majority of the inspiratory phase and define the first portion of the expiratory phase as corresponding to at least a majority of the expiratory phase.

27. The system of claim 26, wherein the majority of the inspiratory phase comprises at least two-thirds of the inspiratory phase and the majority of the expiratory phase comprises at least two-thirds of the expiratory phase.