TRANSVENOUS METHOD OF TREATING SLEEP APNEA

• US 20110202119A1
• Filed: 09/30/2009
• Published: 08/18/2011
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Rondoni, John, Ni, Quan, Christopherson, Mark, Herbert, Timothy
• Granted Patent: US 9,889,299 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/704 Tables
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A system and method for treating sleep apnea includes inserting an implantable pulse generator subcutaneously within a body of a patient and connecting a lead to the pulse generator. The lead is inserted within the vasculature and advanced transvenously through the vasculature until a stimulation portion of the lead becomes positioned in close proximity to the hypoglossal nerve. A nerve-stimulation signal is applied to the hypoglossal nerve via the stimulation portion of the lead.

Claims

1. A method of treating sleep apnea, comprising:

inserting an implantable pulse generator subcutaneously within a body of a patient and connecting a lead to the pulse generator;

inserting a lead within the vasculature and advancing the lead transvenously through the vasculature;

positioning a stimulation portion of the lead in close proximity to the hypoglossal nerve; and

applying a nerve-stimulation signal to the hypoglossal nerve via the stimulation portion of the lead.

2. The method of claim 1, wherein applying the nerve-stimulation signal comprises:

synchronizing the application of the nerve-stimulation signal with respiration.

3. The method of claim 2, wherein synchronizing the application comprises:

applying the nerve-stimulation signal to occur at each respiratory breath.

4. The method of claim 2, comprising at least one of:

sensing the at least one respiratory feature via positioning a first respiration sensor on an exterior surface of a patient'"'"'s body;

or

sensing the at least one respiratory feature via delivering a second respiration sensor subcutaneously within an upper body portion of a patient'"'"'s body.

5. The method of claim 4, comprising:

coupling at least one of the respective first and second respiration sensors to the implantable pulse generator.

6. The method of claim 4, comprising:

providing the second respiration sensor on a sensor portion of the lead.

7. The method of claim 4, wherein sensing the at least one respiratory feature comprises at least one of:

measuring a trans-thoracic bio-impedance to track the relative amplitude of the respiratory waveform.

8. The method of claim 4, wherein sensing the at least one respiratory feature including additionally measuring at least one of:

a body motion parameter;

an electrocardiography parameter;

a respiratory flow parameter;

a blood oxygen parameter; and

a time-of-day parameter.

9. The method of claim 7, comprising:

determining an average peak amplitude based on the tracked relative amplitudes; and

detecting, via the at least one respiratory feature, an apneic respiration pattern as cyclic variations of an amplitude of the trans-thoracic bio-impedance relative to the average peak amplitude for a duration corresponding to a nominal apneic duration.

10. The method of claim 1, wherein applying the nerve-stimulation signal comprises:

detecting an apneic-indicative respiratory pattern prior to applying the nerve-stimulation signal;

synchronizing the application of the nerve-stimulation signal with respiration; and

discontinuing application of the nerve-stimulation signal when the apneic-indicative respiratory pattern is no longer detected.

11. The method of claim 1, wherein the lead includes:

a base portion;

a first portion extending from the base portion; and

a second portion extending from the base portion and being separate from the first portion, wherein the second portion includes the stimulation portion.

12. The method of claim 1, including:

coupling a base portion of the lead to the pulse generator;

arranging a first portion to extend from the base portion; and

arranging a second portion to extend from the base portion and separate from the first portion.

13. The method of claim 12, comprising:

delivering the first portion to a first hypoglossal nerve on a first side of the body and defining the first portion to include a first stimulation electrode structure of the stimulation portion; and

delivering the second portion to a second hypoglossal nerve on a second side of the body and defining the second portion to include a second stimulation electrode structure of the stimulation portion.

14. The method of claim 13, comprising:

applying the stimulation signal in an alternating pattern between the first stimulation electrode on the first side of the body and the second stimulation electrode on the second side of the body.

15. The method of claim 13, comprising:

applying the stimulation signal simultaneously at the first stimulation electrode on the first side of the body and at the second stimulation electrode on the second side of the body.

16. The method of claim 12, comprising:

delivering the first portion within a first vein of vasculature to be in close proximity to a hypoglossal nerve on a first side of the body and defining the first portion to include a first stimulation electrode structure of the stimulation portion; and

delivering the second portion within a second vein of the vasculature to be in close proximity to the hypoglossal nerve on the first side of the body and defining the second portion to include a second stimulation electrode structure of the stimulation portion.

17. The method of claim 12, comprising:

delivering the first portion within a first vein of vasculature to be in close proximity to a hypoglossal nerve on a first side of the body and defining the first portion to include a first stimulation electrode structure of the stimulation portion; and

delivering the second portion within a second vein of the vasculature to be in close proximity to a second nerve on the first side of the body and defining the second portion to include a second stimulation electrode structure of the stimulation portion, wherein the second nerve innervates a respiration-related muscle.

18. The method of claim 1, comprising:

arranging the stimulation portion to include an array of independently programmable electrode elements spaced apart from each other along a length of the stimulation portion and spaced apart from each other circumferentially on the outer surface of the stimulation portion; and

identifying at least one target site along a length of the hypoglossal nerve via applying a stimulation signal to different combinations of the electrode elements and evaluating which combination of electrode elements achieves an efficacious respiratory airway patency.

19. The method of claim 1, comprising:

arranging the stimulation portion to include an array of electrodes spaced apart from each other along a length of the stimulation portion; and

identifying at least one target site along a length of the hypoglossal nerve via applying a stimulation signal separately to each electrode or electrode combination, on a one-at-a-time basis, and evaluating which electrode or electrode combination achieves an efficacious respiratory airway patency.

20. The method of claim 19, wherein each electrode comprises a ring electrode.

21. The method of claim 19, comprising:

identifying the efficacious respiratory airway patency via identifying, upon application of the test neurostimulation signal, which ring electrode produces at least one of;

a longest duration of increased airway patency;

a largest size of increased airway patency;

or

a substantial reduction in apnea events.

22. The method of claim 19, comprising:

arranging a length of the array to substantially match a majority of a length of the hypoglossal nerve extending from a position near the jugular vein toward the genioglossus muscle; and

determining which electrodes of the array produce the efficacious respiratory airway patency without repositioning the stimulation portion within the vasculature after the stimulation is first positioned in close proximity to the hypoglossal nerve.

23. The method of claim 19, wherein identifying the at least one target portion comprises determining the most efficacious response for each potential target site via at least one of:

determining a degree of tongue motor response;

determining an increased cross-sectional area of an upper respiratory airway;

determining a degree of electromyography response of one or more tongue-protrusion related muscles;

detecting a twitch from either the tongue or laryngeal muscle;

or

detecting a reduction in apnea events.

24. The method of claim 19, comprising:

determining, at each potential target site of the hypoglossal nerve, a therapeutic neurostimulation signal via applying a test neurostimulation signal while iteratively varying a value for each signal parameter of a plurality of signal parameters, wherein the signal parameters include at least one of an amplitude, a pulse width, an electrode polarity, a duration, and/or a frequency.

25. The method of claim 1, comprising:

arranging the stimulation portion to include an array of ring electrodes spaced apart from each other along a length of the stimulation portion; and

identifying a target portion of the hypoglossal nerve via applying a stimulation signal different combinations of the respective ring electrodes to determine which selectable combination of ring electrode produces a highest degree of respiratory airway patency.

26. The method of claim 25, comprising:

applying the stimulation signal simultaneously from the selected combination of ring electrodes.

27. The method of claim 1, wherein positioning the stimulation portion comprising:

providing the lead as single lead and arranging the stimulation portion on a distal portion of the single lead and arranging a respiratory sensing portion on a proximal portion of the single lead; and

distally advancing the single lead within the vasculature to simultaneously cause;

positioning the stimulation portion within first vein in close proximity to the hypoglossal nerve and within a neck region of the patient; and

positioning the respiratory sensing portion within a second vein within a pectoral region of the patient, the second vein in fluid communication with the first vein.

28. The method of claim 27, wherein the first vein comprises a ranine vein and the second vein comprises a subclavian vein.

29. The method of claim 27, comprising:

arranging the sensing portion as a first sensing element and a second sensing element spaced apart from the first sensing element along a length of the single lead.

30. The method of claim 29, comprising:

performing sensing a trans-thoracic bio-impedance relating to respiratory patterns via measuring a voltage across at least one of;

the first sensing element relative to the second sensing element;

or

one of the respective first and second sensing elements relative to a conductive case of the pulse generator.

31. The method of claim 1, comprising:

maintaining the stimulation portion in close proximity to the hypoglossal nerve by anchoring the stimulation portion relative to the vasculature via at least one of;

arranging the stimulation portion as at least part of a coil structure movable between a generally straight state during advancement through the vasculature and an expanded, coiled state at the position for stimulating the hypoglossal nerve;

or

arranging the stimulation portion as at least part of a stent structure movable between a generally collapsed state during advancement through the vasculature and an expanded state at the position for stimulating the hypoglossal nerve.

32. The method of claim 1, wherein positioning the stimulation portion comprises:

providing the stimulation portion as at least part of an anchoring mechanism;

advancing the stimulation portion within the vasculature, with the anchoring mechanism in a generally collapsed state, to a first test stimulation site along the hypoglossal nerve;

manipulating the anchoring mechanism into an expanded state to engage a side wall of the vasculature at the first test stimulation site and applying a first neurostimulation test signal, via the stimulation portion, to the hypoglossal nerve;

manipulating the anchoring mechanism into the generally collapsed state to disengage the anchoring mechanism from the side wall of the vasculature and advancing the stimulation portion to a second test stimulation site spaced apart along the length of the hypoglossal nerve from the first test stimulation site; and

manipulating the anchoring mechanism into the expanded state to re-engage the side wall of the vasculature and applying a second neurostimulation test signal, via the stimulation portion, the hypoglossal nerve.

33. The method of claim 32, comprising providing the anchor mechanism at a distal portion of the lead as a stent structure including a generally tubular member, wherein the collapsed state corresponds to a first diameter of the stent structure and the expanded state corresponds to a second diameter substantially larger than the first diameter and sized to engage the side wall of the vasculature.

34. The method of claim 32, comprising providing the anchor mechanism at a distal portion of the lead as a coil configuration, wherein the collapsed state corresponds to a generally straight shape achieved via insertion of a guide wire through the distal portion of the lead and the expanded state corresponds to radial expansion of distal portion from the generally straight shape into the coil configuration with the radially expanded coil configuration sized to engage the side wall of the vasculature.

35. The method of claim 32, comprising providing the anchor mechanism at a distal portion of the lead as an array of tines located radially about an outer surface of the lead, and when in the generally collapsed state, the tines lay generally flat against the outer surface of the lead and when in the expanded state, the tines protrude generally outward and away from the outer surface of the lead.

36. A method of treating sleep apnea, comprising:

inserting an implantable pulse generator subcutaneously within a body of a patient and connecting a lead to the pulse generator;

inserting a lead within the vasculature and advancing the lead through the vasculature;

positioning an electrode portion of the lead in close proximity to the hypoglossal nerve; and

monitoring respiratory patterns via changes in bio-impedance measured via the electrode portion;

applying, via the electrode portion, a nerve-stimulation signal to the hypoglossal nerve.

37. The method of claim 36, comprising:

synchronizing the application of the nerve-stimulation signal with each respiration breath based on the monitored respiratory patterns.

38. The method of claim 36, wherein applying the nerve-stimulation signal comprises:

detecting, within the monitored respiratory pattern, an apneic-indicative pattern prior to applying the nerve-stimulation signal;

synchronizing the application of the nerve-stimulation signal with respiration; and

discontinuing application of the nerve-stimulation signal when the apneic-indicative pattern is no longer detected within the monitored respiratory pattern.

39. The method of claim 38, comprising arranging the lead to include a first portion and a second portion, and wherein positioning the electrode portion comprises:

providing the lead as a first arm and a second arm and arranging the electrode portion as a first electrode structure on the first arm and a second electrode structure on the second arm of the lead;

advancing the first arm of the lead within the vasculature on a first side of the body to position the first electrode structure in close proximity to the hypoglossal nerve on the first side of the body; and

advancing the second arm of the lead within the vasculature on a second side of the body to position the second electrode structure in close proximity to the hypoglossal nerve on the second side of the body.

40. The method of claim 39, wherein monitoring the respiratory pattern comprises:

measuring a bioimpedance with the first electrode structure on the first side of the body and the second electrode structure on the second side of the body.

41. The method of claim 40, comprising measuring the bioimpedance as at least one of a trans-laryngeal bio-impedance or a trans-pharyngeal bio-impedance.

42-57. -57. (canceled)