IP Library Granted Patent US 10,864,375
Granted Patent B2
US 10,864,375 · App. 16/102,471 · Granted Dec 15, 2020

Devices and methods for sleep apnea treatment

Inventors: Stephen Bolea (Watertown, MN); Wondimeneh Tesfayesus (St. Paul, MN); John Beck (Prior Lake, MN); Thomas Hoegh (Edina, MN); Robert Atkinson (Lake Elmo, MN); Sidney Hauschild (Cottage Grove, MN)
Assignee: LivaNova USA, Inc.
A61N1/3611A61F5/566A61N1/3601A61B2017/248
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Quick Facts
Patent No.
US 10,864,375
App. No.
16/102,471
Granted
Dec 15, 2020
Kind
B2
Abstract

Devices and methods for improving the coupling between the soft palate and the genioglossus. This may be accomplished, for example, but shortening or stiffening the palatoglossal arch. Improved coupling between the soft palate and the genioglossus may be beneficial to a patient suffering from obstructive sleep apnea (OSA) as a stand-alone procedure, or in combination procedures and devices that cause anterior displacement of the tongue such as hypoglossal nerve stimulation, genioglossus advancement surgery, mandibular advancement surgery, mandibular advancement (oral) appliances, etc.

Claims (30)

1. A method of treating an upper airway tissue collapse condition of a patient, comprising:

implanting at least one tissue engagement member in the patient's upper airway to tighten the patient's upper airway tissue from a first condition of the patient's upper airway tissue to a second condition of the patient's upper airway tissue that has a greater stiffness than the first condition, the patient's upper airway tissue in the second condition conveying anterior movement of the patient's tongue to maintain a patency of the patient's upper airway, wherein the at least one tissue engagement member extends between the patient's genioglossus muscle and a portion of the patient's upper airway tissue; and

disposing a stimulation device configured for delivering an electrical stimulation to a nerve innervating a tongue protrusion muscle of the patient to cause anterior movement of the patient's tongue,

wherein the electrical stimulation improves an efficacy of the at least one tissue engagement member.

2. The method of claim 1 , wherein tightening the patient's upper airway tissue includes tightening the patient's pharyngeal tissue.

3. The method of claim 2 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatoglossus.

4. The method of claim 2 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatopharyngeus.

5. The method of claim 2 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's pharyngoepiglottic fold.

6. The method of claim 1 , wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the delivering of the electrical stimulation mitigates the obstructive sleep apnea condition.

7. The method of claim 1 , wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and

wherein the delivering of the electrical stimulation corresponds to a mitigation of the first tissue collapse at the first location, and wherein the tightening of the patient's upper airway tissue corresponds to a mitigation of the second tissue collapse at the second location.

8. The method of claim 1 , wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and

wherein the delivering of the electrical stimulation corresponds to a mitigation of the first tissue collapse at the first location, and wherein an upper airway movement due to the electrical stimulation and the tightening of the patient's upper airway tissue corresponds to a mitigation of both the first tissue collapse and the second tissue collapse.

9. The method of claim 1 , wherein the stimulation device is further configured to modify the electrical stimulation signal in response to receiving a signal from an external therapy controller.

10. The method of claim 1 , further comprising implanting a sensing lead in the patient, wherein the stimulation device is further configured to sense inspirations of the patient via the sensing lead and deliver the electrical stimulation synchronized with the sensed inspirations of the patient.

11. A system for treating an upper airway condition of a patient, the system comprising:

at least one tissue engagement member configured for implantation in the patient's upper airway to tighten the patient's upper airway tissue from a first condition of the patient's upper airway tissue to a second condition of the patient's upper airway tissue that has a greater stiffness than the first condition, the patient's upper airway tissue in the second condition conveying anterior movement of the patient's tongue to maintain a patency of the patient's upper airway, wherein the at least one tissue engagement member extends between the patient's genioglossus muscle and a portion of the patient's upper airway tissue; and

a stimulation device configured for delivering an electrical stimulation to a nerve innervating a tongue protrusion muscle of the patient to cause anterior movement of the patient's tongue;

wherein the electrical stimulation is configured to improve an efficacy of the at least one tissue engagement member.

12. The system of claim 11 , wherein tightening the patient's upper airway tissue includes tightening the patient's pharyngeal tissue.

13. The system of claim 12 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatoglossus.

14. The system of claim 12 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatopharyngeus.

15. The system of claim 12 , wherein tightening the patient's pharyngeal tissue includes shortening the patient's pharyngoepiglottic fold.

16. The system of claim 11 , wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the electrical stimulation is configured to mitigate the obstructive sleep apnea condition.

17. The system of claim 11 , wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and

wherein the electrical stimulation is configured to mitigate the first tissue collapse at the first location and the tightening of the patient's upper airway tissue corresponds to a mitigation of the second tissue collapse at the second location.

18. The system of claim 11 , wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and

wherein the electrical stimulation is configured to mitigate the first tissue collapse at the first location, and wherein an upper airway movement due to the electrical stimulation and the tightening of the patient's upper airway tissue corresponds to a mitigation of both the first tissue collapse and the second tissue collapse.

19. The system of claim 11 , further comprising an external therapy controller, wherein the stimulation device is further configured to modify the electrical stimulation signal in response to receiving a signal from the external therapy controller.

20. The system of claim 11 , further comprising a sensing lead configured for implantation in the patient, wherein the stimulation device is further configured to sense inspirations of the patient via the sensing lead and deliver the electrical stimulation synchronized with the sensed inspirations of the patient.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: LIVANOVA USA, INC.
Reel/Frame 057552/0378 →
SECURITY INTEREST Recorded Aug 16, 2021
From: LIVANOVA USA, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: LIVANOVA USA, INC.
Reel/Frame 057189/0001 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: LIVANOVA USA, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0784 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: LIVANOVA USA, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 053673/0675 →