IP Library › Granted Patent US 12,616,839
Granted Patent B2
US 12,616,839 · App. 17/683,933 · Granted May 5, 2026

System and method to modulate phrenic nerve to prevent sleep apnea

Inventors: Mark Gelfand (New York, NY); Howard R. Levin (Teaneck, NJ); Andrew Halpert (Coral Springs, FL)
Assignee: ZOLL RESPICARDIA, INC.
A61N1/3611A61B5/08A61B5/0816A61B5/0826A61N1/0551A61N1/3601A61N1/3614A61B5/4818A61N1/36135A61N1/3615
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Quick Facts
Patent No.
US 12,616,839
App. No.
17/683,933
Granted
May 5, 2026
Kind
B2
Abstract

An implantable medical device for treating breathing disorders such as central sleep apnea wherein stimulation is provided to the phrenic nerve through a transvenous lead system with the stimulation beginning after inspiration to extend the duration of a breath and to hold the diaphragm in a contracted condition.

Claims (26)

1 . A medical device for use in a patient comprising:

a single transvenous stimulation lead comprising at least one stimulation electrode and configured to be placed in a vein adjacent to a phrenic nerve of the patient;

an implanted medical device (IMD) configured

to be implanted in a body of the patient,

to be electrically connected to the single transvenous stimulation lead and to the at least one stimulation electrode via the single transvenous stimulation lead, and

to receive a respiration signal via the single transvenous stimulation lead;

and

control logic incorporated within the IMD, the control logic configured to analyze the respiration signal and deliver stimulation pulses to maintain activation of at least a portion of a diaphragm of the patient, wherein the control logic is configured to be able to deliver consistent amplitude stimulation pulses, progressively increasing amplitude stimulation pulses, progressively decreasing amplitude stimulation pulses, and pulses in which an amplitude of the stimulation pulses increases and then decreases, and to be able to select for delivery one of the consistent amplitude stimulation pulses, the progressively increasing amplitude stimulation pulses, the progressively decreasing amplitude stimulation pulses, or the pulses in which the amplitude of the stimulation pulses increases and then decreases.

2 . The medical device of claim 1 wherein the control logic is further configured to deliver the stimulation pulses at a time proximate a transition from an inhalation phase of respiration to an exhalation phase of respiration.

3 . The medical device of claim 2 wherein the control logic is further configured to analyze the respiration signal and deliver the stimulation pulses at an end of naturally initiated inspiration.

4 . The medical device of claim 2 wherein the control logic is further configured to analyze the respiration signal and deliver the stimulation pulses for a duration that exceeds naturally initiated exhalation.

5 . The medical device of claim 2 wherein the control logic is further configured to analyze the respiration signal and deliver the stimulation pulses at an end of naturally initiated inspiration and for a duration that exceeds naturally initiated exhalation.

6 . The medical device of claim 1 further comprising an implantable motion sensor capable of sensing motion of the patient, wherein the control logic is capable of sensing and analyzing motion signals.

7 . The medical device of claim 6 wherein the control logic is further configured to deliver phrenic nerve stimulation based on the respiration signal and to disable the phrenic nerve stimulation based on the motion signals.

8 . The medical device of claim 6 wherein the implantable motion sensor is an accelerometer.

9 . The medical device of claim 1 wherein the control logic is configured to reject respiration signals indicative of cough, arousal, or movement.

10 . The medical device of claim 1 wherein the control logic is configured to reject respiration signals that appear during a refractory period that follows a stimulation pulse.

11 . The medical device of claim 1 wherein the single transvenous stimulation lead includes a plurality of stimulation electrodes, the plurality of stimulation electrodes including the at least one stimulation electrode.

12 . The medical device of claim 11 wherein stimulation provided by the plurality of stimulation electrodes is bipolar.

13 . The medical device of claim 1 wherein stimulation provided by the at least one stimulation electrode is monopolar.

14 . The medical device of claim 1 wherein the single transvenous stimulation lead has at least one anchoring mechanism.

15 . The medical device of claim 1 where the at least one stimulation electrode is coated with medication.

16 . The medical device of claim 1 wherein the control logic is configured to calculate an observed breathing rate based on the respiration signal and to deliver the stimulation pulses at a fixed stimulation rate that is less than the observed breathing rate.

17 . The medical device of claim 1 wherein the at least one stimulation electrode is configured to be retained in a pericardiophrenic vein.

18 . The medical device of claim 1 , wherein the at least one stimulation electrode and a can of the IMD form a transthoracic impedance sensor to provide the respiration signal.

19 . The medical device of claim 1 , wherein the phrenic nerve is a right phrenic nerve or a left phrenic nerve.

Assignments (3)
CHANGE OF NAME Recorded Mar 2, 2022
From: CARDIAC CONCEPTS, INC.
To: RESPICARDIA, INC.
Reel/Frame 059692/0078 →
CHANGE OF NAME Recorded Mar 2, 2022
From: RESPICARDIA, INC.
To: ZOLL RESPICARDIA, INC.
Reel/Frame 059692/0080 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2022
From: GELFAND, MARK; LEVIN, HOWARD R.; HALPERT, ANDREW
To: CARDIAC CONCEPTS, INC.
Reel/Frame 059142/0265 →
Continuity (7)
Continuation 14715128 · May 18, 2015
Continuation 13538713 · Jun 29, 2012
Continuation 11601150 · Nov 17, 2006
Provisional Application 60743326 · Feb 21, 2006
Provisional Application 60743062 · Dec 21, 2005
Provisional Application 60737808 · Nov 18, 2005
Related Publication 20220176119A1 · Jun 9, 2022
References Cited (185)
US 4129125A · Lester · 1978 [cited by examiner]
US 4169479A · Muto · 1979 [cited by applicant]
US 4827935A · Geddes et al. · 1989 [cited by applicant]
US 4830008A · Meer · 1989 [cited by applicant]
US 5056519A · Vince · 1991 [cited by applicant]
US 5146918A · Kallok et al. · 1992 [cited by applicant]
US 5170802A · Mehra · 1992 [cited by applicant]
US 5174287A · Kallok et al. · 1992 [cited by applicant]
US 5184621A · Vogel et al. · 1993 [cited by applicant]
US 5211173A · Kallok et al. · 1993 [cited by applicant]
US 5265604A · Vince · 1993 [cited by applicant]
US 5483969A · Testerman et al. · 1996 [cited by applicant]
US 5485851A · Erickson · 1996 [cited by applicant]
US 5531781A · Alferness et al. · 1996 [cited by applicant]
US 6006134A · Hill et al. · 1999 [cited by applicant]
US 6132384A · Christopherson et al. · 2000 [cited by applicant]
US 6212435B1 · Lattner et al. · 2001 [cited by applicant]
US 6266564B1 · Hill et al. · 2001 [cited by applicant]
US 6301507B1 · Bakels et al. · 2001 [cited by applicant]
US 6360740B1 · Ward et al. · 2002 [cited by applicant]
US 6415183B1 · Scheiner et al. · 2002 [cited by applicant]
US 6449507B1 · Hill et al. · 2002 [cited by applicant]
US 6456863B1 · Levin et al. · 2002 [cited by applicant]
US 6463327B1 · Lurie et al. · 2002 [cited by applicant]
US 6532388B1 · Hill et al. · 2003 [cited by applicant]
US 6537228B1 · Lambert · 2003 [cited by applicant]
US 6542774B2 · Hill et al. · 2003 [cited by applicant]
US 6587726B2 · Lurie et al. · 2003 [cited by applicant]
US 6589188B1 · Street et al. · 2003 [cited by applicant]
US 6641542B2 · Cho et al. · 2003 [cited by applicant]
US 6684101B2 · Daum · 2004 [cited by applicant]
US 6714823B1 · De Lurgio et al. · 2004 [cited by applicant]
US 6718208B2 · Hill et al. · 2004 [cited by applicant]
US RE38705E · Hill et al. · 2005 [cited by applicant]
US 6881192B1 · Park · 2005 [cited by applicant]
US 6890306B2 · Poezevera · 2005 [cited by applicant]
US 6928324B2 · Park et al. · 2005 [cited by applicant]
US 6934583B2 · Weinberg et al. · 2005 [cited by applicant]
US 6937903B2 · Schuler et al. · 2005 [cited by applicant]
US 6964641B2 · Cho et al. · 2005 [cited by applicant]
US 7025730B2 · Cho et al. · 2006 [cited by applicant]
US 7070568B1 · Koh · 2006 [cited by applicant]
US 7077132B2 · Berthon-Jones · 2006 [cited by applicant]
US 7082331B1 · Park · 2006 [cited by examiner]
US 7094207B1 · Koh · 2006 [cited by applicant]
US 7155278B2 · King et al. · 2006 [cited by applicant]
US 7179229B1 · Koh · 2007 [cited by applicant]
US 7184829B2 · Hill et al. · 2007 [cited by applicant]
US 7200442B1 · Koh et al. · 2007 [cited by applicant]
US 7212862B2 · Park et al. · 2007 [cited by applicant]
US 7223244B1 · Koh · 2007 [cited by applicant]
US 7225019B2 · Jahns et al. · 2007 [cited by applicant]
US 7225021B1 · Park et al. · 2007 [cited by applicant]
US 7245971B2 · Park et al. · 2007 [cited by applicant]
US 7269457B2 · Shafer et al. · 2007 [cited by applicant]
US 7269459B1 · Koh · 2007 [cited by applicant]
US 7277757B2 · Casavant et al. · 2007 [cited by applicant]
US 7340302B1 · Falkenberg et al. · 2008 [cited by applicant]
US 7357775B1 · Koh · 2008 [cited by applicant]
US 7361146B1 · Bharmi et al. · 2008 [cited by applicant]
US 7363086B1 · Koh et al. · 2008 [cited by applicant]
US 7371220B1 · Koh et al. · 2008 [cited by applicant]
US 7628801B2 · Westlund et al. · 2009 [cited by applicant]
US 7647115B2 · Levin et al. · 2010 [cited by applicant]
US 7747323B2 · Libbus et al. · 2010 [cited by applicant]
US 7787946B2 · Stahmann et al. · 2010 [cited by applicant]
US 8086314B1 · Kieval · 2011 [cited by applicant]
US 8131372B2 · Levin et al. · 2012 [cited by applicant]
US 8200336B2 · Tehrani et al. · 2012 [cited by applicant]
US 8244359B2 · Gelfand · 2012 [cited by examiner]
US 8255056B2 · Tehrani · 2012 [cited by applicant]
US 8280513B2 · Tehrani et al. · 2012 [cited by applicant]
US 8290595B2 · Kieval et al. · 2012 [cited by applicant]
US 8348941B2 · Tehrani · 2013 [cited by applicant]
US 8463401B2 · Jones et al. · 2013 [cited by applicant]
US 10406366B2 · Westlund et al. · 2019 [cited by applicant]
US 10518090B2 · Gelfand et al. · 2019 [cited by applicant]
US 20010003799A1 · Boveja · 2001 [cited by applicant]
US 20020165535A1 · Lesh et al. · 2002 [cited by applicant]
US 20020165536A1 · Kelley et al. · 2002 [cited by applicant]
US 20030050681A1 · Pianca et al. · 2003 [cited by applicant]
US 20030195571A1 · Burnes et al. · 2003 [cited by applicant]
US 20040088015A1 · Casavant et al. · 2004 [cited by applicant]
US 20050021102A1 · Ignagni · 2005 [cited by examiner]
US 20050043765A1 · Williams et al. · 2005 [cited by applicant]
US 20050061320A1 · Lee et al. · 2005 [cited by applicant]
US 20050085734A1 · Tehrani · 2005 [cited by applicant]
US 20050085865A1 · Tehrani · 2005 [cited by applicant]
US 20050085866A1 · Tehrani · 2005 [cited by applicant]
US 20050085867A1 · Tehrani et al. · 2005 [cited by applicant]
US 20050085868A1 · Tehrani · 2005 [cited by examiner]
US 20050085869A1 · Tehrani et al. · 2005 [cited by applicant]
US 20050165457A1 · Benser et al. · 2005 [cited by applicant]
US 20050197588A1 · Freeberg · 2005 [cited by examiner]
US 20050240240A1 · Park et al. · 2005 [cited by applicant]
US 20050288729A1 · Libbus et al. · 2005 [cited by applicant]
US 20050288759A1 · Jones et al. · 2005 [cited by applicant]
US 20060030894A1 · Tehrani · 2006 [cited by applicant]
US 20060036294A1 · Tehrani · 2006 [cited by applicant]
US 20060041277A1 · Deem et al. · 2006 [cited by applicant]
US 20060041295A1 · Osypka · 2006 [cited by applicant]
US 20060084060A1 · Nagahama et al. · 2006 [cited by applicant]
US 20060122662A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060142815A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060149334A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060155341A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060167523A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060229677A1 · Moffitt · 2006 [cited by examiner]
US 20060247729A1 · Tehrani et al. · 2006 [cited by applicant]
US 20060247750A1 · Seifert et al. · 2006 [cited by applicant]
US 20070021795A1 · Tehrani · 2007 [cited by applicant]
US 20070118183A1 · Gelfand et al. · 2007 [cited by applicant]
US 20070129643A1 · Kwok et al. · 2007 [cited by applicant]
US 20070260285A1 · Libbus et al. · 2007 [cited by applicant]
US 20070282376A1 · Shuros et al. · 2007 [cited by applicant]
US 20080154330A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080161878A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080167695A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080177347A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080183239A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080183240A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080183264A1 · Bly et al. · 2008 [cited by applicant]
US 20080188903A1 · Tehrani et al. · 2008 [cited by applicant]
US 20080188904A1 · Tehrani et al. · 2008 [cited by applicant]
US 20090036947A1 · Westlund et al. · 2009 [cited by applicant]
US 20130165989A1 · Gelfand et al. · 2013 [cited by applicant]
US 20130296973A1 · Tehrani · 2013 [cited by examiner]
US 20160001072A1 · Gelfand et al. · 2016 [cited by applicant]
US 20220212005A9 · Westlund et al. · 2022 [cited by applicant]
US 20250082929A1 · Westlund et al. · 2025 [cited by applicant]
EP 1588735A1 · 2005 [cited by applicant]
EP 2371416A1 · 2011 [cited by applicant]
WO 2008092246A1 · 2008 [cited by applicant]
Aiyar, Harish et al., Diaphragm Pacing for Chronic Respiratory Insufficient, CRC Press, LLC, 2001, Chapter 9. [cited by applicant]
Bilgutay, A.M. et al., Augmented Ventilation by Synchronous Phrenic Nerve Stimulation, Trans. Amer. Soc. Artif. Int. Organs, 1970, vol. XVI, pp. 213-217. [cited by applicant]
Brack, Thomas, Cheyne-Stokes Respiration in Patients with Congestive Heart Failure, Swiss Med Wkly 2003; 133:605-610, www.smw.ch. [cited by applicant]
Canadian Office Action dated Jan. 4, 2016 for corresponding Canadian Application No. 2,865,410, filed Sep. 14, 2014. [cited by applicant]
Canadian Office Action dated Jul. 12, 2017 for corresponding Canadian Application No. 2,865,410, filed Sep. 26, 2014. [cited by applicant]
Canadian Office Action dated Jun. 29, 2018 for corresponding Canadian Application No. 2,865,410, filed Sep. 26, 2014. [cited by applicant]
Canadian Office Action dated Nov. 17, 2016 for corresponding Canadian Application No. 2,865,410. [cited by applicant]
Caples, Sean M. et al., Influence of Cardiac Function and Failure on Sleep-Disordered Breathing, Journal of Applied Physiology 2005, vol. 99, pp. 2433-2439. [cited by applicant]
Chatfield, Paul O. et al., Role of Pulmonary. Proprioceptive Reflexes in Suppression of Spontaneous Breathing During Electrophrenic. Respiration, Dept. of Physiology, Harvard Medical School, and Dept. of Physiology, Har… [cited by applicant]
Canadian Office Action for CA 2,865,410, dated May 3, 2019, 4 Pages. [cited by applicant]
Canadian Office Action, Application No. 2,865,410, dated May 2, 2020, 4 pages. [cited by applicant]
Diedrichs, Holger et al., Symptomatic Relief Precedes Improvement of Myocardia Blood Flow in Patients Under Spinal Coard Stimulation, BioMed Central, 2005, pp. 1-7. [cited by applicant]
Dobelle, William H., Use of Breathing Pacemakers to Suppress Intractable Hiccups of up to Thirteen Years Duration, ASAIO Journal 1999, pp. 524-525. [cited by applicant]
Esler, Murray et al., Is Obstructive Sleep Apnea the Cause of Sympathetic Nervous Activation in Human Obesity?, Journal of Applied Physiology 2006, vol. 100, pp. 11-12. [cited by applicant]
Furman, Seymour, MD et al., Transvenous Stimulation of the Phrenic Nerves, Journal of Thoracic and Cardiovascular Surgery, vol. 62, No. 5, 1971, pp. 743-751. [cited by applicant]
Garrido-Garcia, H. et al., Treatment of Chronic Ventilatory Failure Using a Diaphragmatic Pacemaker, Spinal Cord (1998) 36, 310-314. [cited by applicant]
Gottfried, Stewart B. et al., Effects of Phrenic Stimulation on Upper Airway Resistance in Anesthetized Dogs, Am Physiological Society 1983, 0161-7567/83, pp. 419-426. [cited by applicant]
Handa, Y. et al., Basic Studies on Electrophrenic Respiration Part 2—Assisted Ventilation by the Synchronous Electrophrenic Respirator, Medical and Biological Engineering, Jul. 1976. [cited by applicant]
International Preliminary Report on Patentability of international application PCT/US2006/044788 (May 20, 2008). 4 pp. [cited by applicant]
International Search Report of international application PCT/US2006/044788 (Aug. 15, 2007). 3 pp. [cited by applicant]
Javaheri, Shahrokh, MD, Central Sleep Apnea in Congestive Heart Failure: Prevalence, Mechanisms, Impact, and Therapeutic Options, Seminars in Respiratory and Critcal Care Medicine, 2005, vol. 26, No. 1. [cited by applicant]
Kaneko, S. et al., A New Approach to Respiratory Assist for Phrenic Nerve Paralysis, Trans Am Soc. Artif Intern Organs, 1985, vol. XXXI, pp. 301-304. [cited by applicant]
Kimura, M. et al., A Heart-Rate-Responsive Diaphragm Pacemaker, Med. & Biol. Eng. & Comput., 1987, 25, 458-462. [cited by applicant]
Kimura, M. et al., Additive to an RF-Coupled Phrenic Nerve Stimulator Implant to Provide Outward Transmission of Body Temperature, Med. & Biol. Eng. & Comput. 1986, 24, 659-661. [cited by applicant]
Kimura, M. et al., Heart Rate and Body Temperature Sensitive Diaphragm Pacing, Med. & Biol. Eng. & Comput. 1992, 30, 155-161. [cited by applicant]
Kingma, John G. Jr. et al., Neuromodulation Therapy Does Not Influence Blood Flow Distribution or Left-Ventricular Dynamics During Acute Myocardial Ischemia, Autonomic Neuroscience: Basic and Clinical 91 (2001) pp. 47-5… [cited by applicant]
Kohnlein, T. et al., Central Sleep Apnoea Syndrome in Patients with Chronic Heart Disease: A Critical Review of the Current Literature, Thorax 2002; 57:547-554. [cited by applicant]
Leuenberger, Urs A. et al., Hypoxia Augments Apnea-Induced Peripheral Vasoconstriction in Humans, Journal of Applied Physiology 2001, vol. 90, pp. 1516-1522. [cited by applicant]
Linderoth, Bengt, MD, PHD et al., Mechanisms of Spinal Cord Stimulation in Painful Syndromes: Role of Animal Models, American Academy of Pain Medicine, vol. 7, No. S14-S26, 2006. [cited by applicant]
Lorenzi-Filho, Geraldo et al., Cheyne-Stokes Respiration in Patients with Congestive Heart Failure: Causes and Consequences, Clinics 2005; 60(4):333-44. [cited by applicant]
Macintyre, Neil R., MD, Setting the. Frequency-Tidal Volume Pattern, www.rcjournal.com/contents/03.02/03.02.0266.asp. [cited by applicant]
Office Action from corresponding Canadian Patent Application No. 2,865,410, dated Feb. 3, 2021. [cited by applicant]
Oliven, Arie, et al., Upper Airway Response to Electrical Stimulation of the Genioglossus in Obstructive Sleep Apnea, Journal of Applied Physiology 2003, vol. 95, pp. 2023-2029. [cited by applicant]
Parati, Gianfranco et al., Sleep Apnea: Epidemiology, Pathophysiology, and Relation to Cardiovascular Risk, Am Journal Physiological Society 2007, vol. 293, pp. R1671-R1683. [cited by applicant]
Planas, Roque F. et al., Diaphragmatic Pressures: Transvenous vs. Direct Phrenic Nerve Stimulation, Am Physiological Society 1985, 0161-7567/85, pp. 269-273. [cited by applicant]
Prosecution History for corresponding U.S. Appl. No. 11/601,150 including: Notice of Allowance and Fee(s) Due mailed Jun. 4, 2012, Final Rejection mailed Jun. 8, 2010, Non-Final Rejection mailed Aug. 20, 2009; and Requi… [cited by applicant]
Prosecution History for corresponding U.S. Appl. No. 12/150,654 including: Notice of Allowance and Fee(s) Due mailed Apr. 30, 2019, Non-Final Rejection mailed Apr. 6, 2018, Final Rejection mailed Mar. 2, 2017, Non-Final… [cited by applicant]
Prosecution History for corresponding U.S. Appl. No. 13/538,713 including: Notice of Allowance and Fee(s) Due mailed lugust 19, 2019, Final Rejection mailed May 15, 2019, Non-Final Rejection mailed Nov. 2, 2018, Final R… [cited by applicant]
Punjabi, Naresh M. et al., Disorders of Glucose Metabolism in Sleep Apnea, Journal of Applied Physiology 2005, vol. 99, pp. 1998-2007. [cited by applicant]
Redline, Susan et al., Beyond the Fat Boy, Journal of Applied Physiology 2005, vol. 99: pp. 1243-1244. [cited by applicant]
Sarnoff, Stanley J. et al., Electrophrenic Respiration IV. The Effectiveness of Contralateral Ventilation During Activity of One Phrenic Nerve, Dept. of Physiology, Harvard School of Public Health, 1949, pp. 929-937. [cited by applicant]
Sarnoff, Stanley J. et al., Electrophrenic Respiration. III. Mechanism of the Inhibition of Spontaneous Respiration, Dept. of Physiology, Harvard School of Public Health, 1948, vol. 155, pp. 203-207. [cited by applicant]
Series, F. et al., Site of Phrenic Nerve Stimulation-Induced Upper Airway Collapse: Influence of Expiratory Time, Journal of Applied Physiology 2002, vol. 92, pp. 665-671. [cited by applicant]
Series, Frederic, Assessment of Upper Airway Dynamics in Awake Patients with Sleep Apnea Using Phrenic Nerve Stimulation, Am Journal Respir Crit Care Med, 2000, vol. 162., pp. 795-800. [cited by applicant]
Stemmer, Edward A. MD et al., Diaphragmatic Pacing in the Treatment of Hypoventilation Syndrome, Journal of Thoracic and Cardiovascular Surgery, vol. 54, No. 5, 1967, pp. 649-657. [cited by applicant]
Taira, Takaomi, MD, Ph.D et al., Phrenic Nerve Stimulation for Diaphragm Pacing with a Spinal Cord Stimulator, Elsevier Science, Surg Neural, 2003; 59:128-32. [cited by applicant]
Tanaka, Satoshi et al., Mechanisms of Sustained Cutaneous Vasodilation Induced by Spinal Cord Stimulation, Autonomic Neuroscience: Basic and Clinical 114 (2004) pp. 55-60. [cited by applicant]
Written Opinion of the International Searching Authorit}' of international application PCT/US2006!044788 (Apr. 12, 2007). 3 pp. [cited by applicant]
Yasuma, Fumihiko et al., Eight-Year Follow-Up Study of a Patient with Central Alveolar Hypoventilation Treated with Diaphragm Pacing, Respiration, 1998; 65:313-316. [cited by applicant]
Yumino, Dai et al., Central Sleep Apnea and Cheyne-Stokes Respiration, Proceedings of the American Thoracic Society, 2008, vol. 5, pp. 226-236. [cited by applicant]
Macintyre, Neil R., MD, Setting the Frequency-Tidal vol. Pattern, www.rcjournal.com/ contents/03.02/03.02.0266.asp. [cited by applicant]
Prosecution History for corresponding U.S. Appl. No. 13/538,713 including: Notice of Allowance and Fee(s) Due mailed Aug. 19, 2019, Final Rejection mailed May 15, 2019, Non-Final Rejection mailed Nov. 2, 2018, Final Rej… [cited by applicant]