IP Library Granted Patent US 10,603,491
Granted Patent B1
US 10,603,491 · App. 14/715,139 · Granted Mar 31, 2020

Detecting and treating disordered breathing

Inventors: Mark Gelfand (New York, NY); Howard R. Levin (Teaneck, NJ); Andrew Halpert (Coral Springs, FL); Antonis Panteleon (Edina, MN)
Assignee: Respicardia, Inc.
A61N1/3601A61B5/0816A61B5/0826A61B5/4818A61N1/3605A61N1/3611A61N1/36514A61B5/0205A61B5/091A61B5/4836A61N1/36139
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Quick Facts
Patent No.
US 10,603,491
App. No.
14/715,139
Granted
Mar 31, 2020
Kind
B1
Abstract

Detection and treatment of disordered breathing is disclosed, with treatment being primarily delivered using electrical stimulation of the diaphragm, either directly or by stimulating appropriate nerves.

Claims (30)

1. A method of treating disordered breathing, the method comprising:

implanting a stimulation lead in a vein of a patient proximate a phrenic nerve;

implanting a respiration sensor within the patient; and

implanting a device within the patient, the device having an energy source, a pulse generator and circuitry, wherein the stimulation lead is electrically coupled to the pulse generator and the respiration sensor is coupled to the to the circuitry, wherein the device:

monitors a signal from the respiration sensor with the circuitry to obtain breathing data regarding the breathing of the patient, the breathing data representative of a tidal volume of breaths of the patient;

determines a breathing data intervention setpoint indicative of a hyperpnea episode;

determines when the breathing data exceeds the breathing data intervention setpoint by monitoring the tidal volume of breaths of the patient; and

provides at least one electric pulse, when there are three sequential breaths where the tidal volume of each breath is at least 20% greater than the tidal volume of the previous breath, to the stimulation electrode to capture the phrenic nerve and extend a duration of a breath to reduce a breathing rate and break a cycle of apnea and hyperpnea.

2. The method of claim 1 , wherein the device determines that the breathing data exceeds the breathing data intervention setpoint only if all of the breaths within ten seconds prior to the first of the three sequential breaths were below 30% of an average tidal volume.

3. The method of claim 1 wherein the device determines a calculated average duration of a hyperpnea episode.

4. The method of claim 3 wherein the device provides the at least one electric pulse for at least 50% as long as the calculated average duration of the hyperpnea episode.

5. The method of claim 3 wherein the device provides the at least one electric pulse for at least 75% as long as the calculated average duration of the hyperpnea episode.

6. The method of claim 1 wherein the at least one electric pulse is in a form of a gradually rising portion and a gradually descending portion.

7. The method of claim 6 wherein the gradually rising portion and the gradually descending portion are in the form of a linear, parabolic or elliptical form.

8. The method of claim 6 wherein the gradually rising portion starts at approximately 50% of a maximum amplitude and increases over 30% of a total duration of the at least one electric pulse to 100% of the maximum amplitude.

9. The method of claim 1 wherein the at least one electric pulse is provided based upon a feedback control based upon a comparison of the breathing data relative to the breathing data intervention setpoint.

10. The method of claim 1 wherein the at least one electric pulse is provided beginning at or after a peak of natural inspiration of the breath when the breath changes from an inspiration phase to an expiration phase.

11. The method of claim 10 wherein the at least one electric pulse delays an end of the expiration phase of the breath.

12. The method of claim 1 wherein the duration of the at least one electric pulse encompasses multiple breaths.

13. The method of claim 1 wherein the at least one electric pulse comprises a pulse train.

14. The method of claim 1 , wherein the at least one electric pulse is provided to the stimulation electrode to stimulate two expiration phases of the breath separated by a still period.

15. The method of claim 1 wherein the at least one electric pulse has a duration of at least ten seconds.

16. A method of treating disordered breathing, the method comprising:

implanting a stimulation lead in a vein of a patient proximate a phrenic nerve;

implanting a respiration sensor within the patient; and

implanting a device within the patient, the device having an energy source, a pulse generator and circuitry, wherein the stimulation lead is electrically coupled to the pulse generator and the respiration sensor is coupled to the to the circuitry, wherein the device is configured to:

monitor a signal from the respiration sensor with the circuitry to obtain breathing data regarding the breathing of the patient;

determine a breathing data intervention setpoint indicative of a hyperpnea episode;

determine when the breathing data exceeds the breathing data intervention setpoint; and

provide at least one electric pulse to the stimulation electrode to capture the phrenic nerve and extend a time duration of a breath, the breath including an inspiration phase and an expiration phase, by extending a time of duration of the expiration phase of the breath to reduce a breathing rate and break a Cheyne-Stokes respiration (CSR) cycle, wherein the at least one electric pulse begins at or after a peak of natural inspiration when the breath changes from the inspiration phase to the expiration phase.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE ADDRESS PREVIOUSLY RECORDED AT REEL: 056267 FRAME: 0334. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME. Recorded May 25, 2021
From: RESPICARDIA, INC.
To: ZOLL RESPICARDIA, INC.
Reel/Frame 056366/0506 →
CHANGE OF NAME Recorded May 17, 2021
From: RESPICARDIA, INC.
To: ZOLL RESPICARDIA, INC.
Reel/Frame 056267/0334 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2021
From: GELFAND, MARK; LEVIN, HOWARD; PANTELEON, ANTONIS; HALPERT, ANDREW
To: CARDIAC CONCEPTS, INC.
Reel/Frame 055716/0293 →
CHANGE OF NAME Recorded Mar 25, 2021
From: CARDIAC CONCEPTS, INC.
To: RESPICARDIA, INC.
Reel/Frame 055727/0783 →
SECURITY INTEREST Recorded Dec 5, 2017
From: RESPICARDIA, INC.
To: ZOLL MEDICAL CORPORATION
Reel/Frame 044298/0216 →
SECURITY INTEREST Recorded Dec 5, 2017
From: RESPICARDIA, INC.
To: CANTOR FITZGERALD SECURITIES, AS AGENT
Reel/Frame 044298/0370 →
Continuity (2)
Continuation 12163500 · Jun 27, 2008
Provisional Application 60937426 · Jun 27, 2007
Cited By (1)
US 12,558,539