Transvenous method of treating sleep apnea

• US 9,889,299 B2
• Filed: 09/30/2009
• Issued: 02/13/2018
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Ni, Quan, Christopherson, Mark A., Herbert, Timothy P., Rondoni, John
• Primary Examiner(s): Patton, Amanda
• Application Number:
  US13/121,862
• Publication Number:
  US 20110202119A1
• Time in Patent Office: 3,058 Days
• Field of Search: 607 42
• 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:

implanting an implantable pulse generator subcutaneously at a pectoral, non-vasculature location within a body of a patient and connecting a single lead to the pulse generator, wherein the single lead includes a stimulation electrode portion that is in electrical communication with the pulse generator, with the stimulation electrode portion being separate from, and independent of, stimulation circuitry of the pulse generator;

inserting the single lead within a non-cardiac vasculature of the body and advancing the single lead through the non-cardiac vasculature; and

positioning the stimulation electrode portion of the single lead within the non-cardiac vasculature in close proximity to the hypoglossal nerve to apply a nerve-stimulation signal, wherein positioning the stimulation electrode portion comprises;

arranging the stimulation electrode 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 non-cardiac vasculature to simultaneously cause;

positioning the stimulation electrode portion within a first vein of the non-cardiac vasculature 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 of the non-cardiac vasculature within a pectoral region of the patient, the second vein in fluid communication with the first vein.

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:

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

wireles sly coupling the second respiration sensor to the implantable pulse generator.

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

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

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

a body motion parameter;

an electrocardiography parameter; and

a blood oxygen parameter.

7. The method of claim 1, comprising:

wherein sensing, via the respiratory sensing portion, the at least one respiratory feature to track the relative amplitude of the respiratory waveform, and

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.

8. 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.

9. 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.

10. 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.

11. The method of claim 10, 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 non-cardiac vasculature after the stimulation is first positioned in close proximity to the hypoglossal nerve.

12. The method of claim 10, 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.

13. The method of claim 10, 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.

14. The method of claim 1, wherein the first vein comprises a ranine vein and the second vein comprises a subclavian vein.

15. The method of claim 1, comprising:

arranging the respiratory 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.

16. The method of claim 15, comprising:

performing sensing a trans-thoracic bio-impedance relating to respiratory patterns via measuring a voltage across the first sensing element relative to the second sensing element.

17. 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 non-cardiac 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 non-cardiac 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 non-cardiac 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 non-cardiac vasculature and applying a second neurostimulation test signal, via the stimulation portion, the hypoglossal nerve.

18. The method of claim 17, comprising providing the anchor mechanism at a distal portion of the single 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 non-cardiac vasculature.

19. The method of claim 1, wherein the implantable pulse generator includes a power supply and the stimulation electrode portion is powered via the single lead by the implantable pulse generator.

20. The method of claim 1, wherein the portion of the single lead extending between the implantable pulse generator and the stimulation electrode portion and which provides electrical communication between the implantable pulse generator and the stimulation electrode portion is without stimulation circuitry.

21. The method of claim 1, comprising:

sensing at least one respiratory feature via delivering a second respiration sensor subcutaneously within a patient'"'"'s body external to the non-cardiac vasculature.

22. The method of claim 21, wherein sensing the at least one respiratory feature includes additionally measuring at least one of:

a respiratory flow parameter; and

a time-of-day parameter.

23. The method of claim 21, comprising:

arranging the second respiration sensor to include at least an accelerometer; and

using measurements from the accelerometer in association with application of the nerve-stimulation signal.

30. The method of claim 23, wherein the accelerometer is configured to measure a body activity parameter at least partially indicative of sleep apnea behavior.

24. A method of treating sleep apnea, comprising:

implanting an implantable pulse generator subcutaneously at a pectoral, non-vasculature location within a body of a patient and connecting a single lead to the pulse generator, wherein a distal portion of the single lead includes a stimulation electrode portion that is in electrical communication with the pulse generator, with the stimulation electrode portion being separate from, and independent of, stimulation circuitry of the pulse generator;

inserting the single lead within a non-cardiac vasculature of the body and advancing the single lead through the non-cardiac vasculature;

positioning the stimulation electrode portion of the single lead within a first vein of the non-cardiac vasculature in a neck region of a patient in close proximity to the hypoglossal nerve to apply a nerve-stimulation signal; and

arranging at least a first portion of a respiratory sensing portion on a second portion of the single lead proximal to, and spaced apart from, the stimulation electrode portion to position the first portion of the respiratory sensing portion within a second vein of the non-cardiac vasculature within the pectoral region of the patient, wherein the second vein is in fluid communication with the first vein.

25. The method of claim 24, comprising:

arranging at least a second portion of the respiratory sensing portion to be implanted within the body in a location external to the non-cardiac vasculature.

26. The method of claim 24, comprising:

arranging at least a second portion of the respiratory sensing portion to be worn externally on the patient'"'"'s body.

27. The method of claim 25, wherein arranging the second portion of the respiratory sensing portion to be at least part of the implanted pulse generator, and comprising:

arranging the second portion to include at least an electrically conductive portion of a case of the implantable pulse generator, and wherein the method further comprises;

determining respiratory information based on a bio-impedance measurable between the respective first and second portions of the respiratory sensing portion.

28. The method of claim 25, comprising:

arranging the second portion of the respiratory sensing portion to include at least an accelerometer; and

using measurements from the accelerometer in association with application of the nerve-stimulation signal.

29. The method of claim 28, wherein the accelerometer is configured to measure a body activity parameter at least partially indicative of sleep apnea behavior.