Obstructive sleep apnea treatment devices, systems and methods

• US 10,632,308 B2
• Filed: 07/31/2017
• Issued: 04/28/2020
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Mazar, Scott T.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US15/665,319
• Publication Number:
  US 20180078761A1
• Time in Patent Office: 1,002 Days
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

A method including chronically implanting a nerve cuff electrode on a portion of a hypoglossal nerve, chronically implanting a respiration sensing lead subcutaneously in a thorax of a patient, the respiration sensing lead having a plurality of bio-impedance electrodes defining at least one bio-impedance vector. The method may also include sensing a bio-impedance signal corresponding to respiration via a bio-impedance vector on an anterior side of the thorax, analyzing the bio-impedance signal to identify onsets of expiration, predicting an onset of a future expiratory phase, and delivering a stimulus to the portion of the hypoglossal nerve via the nerve cuff electrode, wherein the stimulus is delivered as a function of the bio-impedance signal; wherein stimulus delivery is initiated before the onset of the future expiratory phase and continued during an entire inspiratory phase, and wherein the method is performed without identifying an onset of an inspiratory phase.

Claims

1. A hypoglossal stimulation system for delivery of a stimulation signal to a hypoglossal nerve of a patient to treat obstructive sleep apnea, the stimulation system comprising:

an implantable pulse generator having a stimulation port and a respiratory sensing port;

a respiratory sensing lead having a respiratory sensing lead connector coupled to a sensor, the respiratory sensing lead connector being configured to engage the respiratory sensing port; and

a stimulation lead having a lead body with a first lead body end supporting a stimulation lead connector configured to engage the stimulation port and an opposing second lead body end supporting a cuff, the first lead body end having a first sigmoid portion and the second lead body end having a second sigmoid portion, the stimulation lead further having an anchor disposed on the lead body between the first and second sigmoid portions.

2. The stimulation system of claim 1, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid wavelength of approximately 1.0 to 1.5 cm.

3. The stimulation system of claim 1, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid amplitude of approximately 0.75 to 1.5 cm.

4. The stimulation system of claim 2, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid amplitude of approximately 0.75 to 1.5 cm.

5. The stimulation system of claim 1, wherein the anchor has an exterior surface configured to engage a suture disposed to couple the anchor to a non-nerve tissue of the patient.

6. The stimulation system of claim 1, wherein the anchor is interposed between the lead body and a suture disposed to couple the stimulation lead to a non-nerve tissue of the patient.

7. The stimulation system of claim 1, further comprising:

a suture having a first suture end engaging the anchor and an opposing second suture end configured to engage a digastric tissue of the patient.

8. A stimulation lead for use with a neurostimulation device to deliver a stimulation signal to a hypoglossal nerve of a patient, the stimulation lead comprising:

a cuff configured to be disposed about the nerve of the patient;

a connector configured to engage the neurostimulation device;

a lead body extending between the connector and the cuff, the lead body having a first section and a second section, the first section engaging the connector and having a first sigmoid portion, the second section engaging the cuff and having a second sigmoid portion; and

an anchor disposed on the lead body between the first sigmoid portion and the second sigmoid portion.

9. The stimulation lead of claim 8, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid wavelength of approximately 1.0 to 1.5 cm.

10. The stimulation lead of claim 8, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid amplitude of approximately 0.75 to 1.5 cm.

11. The stimulation lead of claim 9, wherein at least one of the first sigmoid portion or the second sigmoid portion defines a sigmoid amplitude of approximately 0.75 to 1.5 cm.

12. The stimulation lead of claim 8, wherein the anchor has an exterior surface configured to engage a suture disposed to couple the anchor to a non-nerve tissue of the patient.

13. The stimulation lead of claim 8, wherein the anchor is interposed between the lead body and a suture disposed to couple the stimulation lead to a non-nerve tissue of the patient.

14. The stimulation lead of claim 8, further comprising:

a suture having a first suture end engaging the anchor and an opposing second suture end configured to engage a digastric tissue of the patient.

15. A stimulation lead for use with a neurostimulation device to deliver a stimulation signal to a hypoglossal nerve of a patient, the stimulation lead comprising:

a cuff configured to be disposed about the nerve of the patient;

a connector configured to engage the neurostimulation device;

a lead body extending between the connector and the cuff, the lead body having a first portion engaging the connector and a second portion engaging the cuff, the first portion having a first variable-length section and the second portion having a second variable-length section, the first and second variable-length sections each having a relaxed length and a deformed length that is longer than the relaxed length; and

an anchor disposed on the lead body between the first and second variable-length sections.

16. The stimulation lead of claim 15, wherein at least one of the first variable-length section or the second variable-length section defines a wavelength of approximately 1.0 to 1.5 cm.

17. The stimulation lead of claim 15, wherein at least one of the first variable-length section or the second variable-length section defines an amplitude of approximately 0.75 to 1.5 cm.

18. The stimulation lead of claim 16, wherein at least one of the first variable-length section or the second variable-length section defines an amplitude of approximately 0.75 to 1.5 cm.

19. The stimulation lead of claim 15, wherein the anchor has an exterior surface configured to engage a suture disposed to couple the anchor to a non-nerve tissue of the patient.

20. The stimulation lead of claim 15, wherein the anchor is interposed between the lead body and a suture disposed to couple the stimulation lead to a non-nerve tissue of the patient.

21. The stimulation lead of claim 15, further comprising:

a suture having a first suture end engaging the anchor and an opposing second suture end configured to engage a digastric tissue of the patient.