US20180221660A1 - Stimulator systems and methods for obstructive sleep apnea - Google Patents
Stimulator systems and methods for obstructive sleep apnea Download PDFInfo
- Publication number
- US20180221660A1 US20180221660A1 US15/885,618 US201815885618A US2018221660A1 US 20180221660 A1 US20180221660 A1 US 20180221660A1 US 201815885618 A US201815885618 A US 201815885618A US 2018221660 A1 US2018221660 A1 US 2018221660A1
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- electrode
- nerve
- electrode contacts
- patient
- cuff body
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Images
Classifications
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/3611—Respiration control
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
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- A61B5/08—Measuring devices for evaluating the respiratory organs
- A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
- A61B5/0836—Measuring rate of CO2 production
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- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/389—Electromyography [EMG]
- A61B5/394—Electromyography [EMG] specially adapted for electroglottography or electropalatography
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- A—HUMAN NECESSITIES
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- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
Definitions
- the electrode lead further comprises at least three axially aligned electrode contacts circumferentially disposed along the inner surface of the cuff body when in the furled state.
- the electrode contacts when the cuff body is in the furled state, circumferentially span at least a 180-degree arc around the inner surface of the cuff body.
- the electrode contacts when the cuff body is in the furled state, circumferentially span at least a 270-degree arc around the inner surface of the cuff body.
- a center-to-center spacing of each pair of adjacent ones of electrode contacts is equal to or less than twice the width of each electrode contact of the respective pair of electrode contacts.
- a neurostimulation system for treating obstructive sleep apnea (OSA) in a patient comprises an electrode lead carrying at least one of the electrode contacts.
- the electrode lead comprises a lead body, and a biologically compatible, flexible, electrically insulative cuff body affixed to distal end of the lead body.
- the method further comprises sequentially delivering an electrical pulse train to each of a plurality of sets of the electrode contacts.
- each set of electrode contacts may comprise a pair of adjacent ones of the electrode contacts, in which case, the electrical pulse train may be sequentially delivered to each set of electrode contacts in a bipolar mode.
- each set of electrode contacts may comprise a single electrode contact and the neurostimulator (or IPG) housing the indifferent or return electrode, in which case, the electrical pulse may be sequentially delivered to each electrode contact or set of contacts in a monopolar mode.
- non-adjacent electrode contact pairs or even more than two non-adjacent contacts may be chosen for either bipolar or monopolar stimulation.
- the measured physiological parameter may comprise a peak-to-peak difference in the concentration of CO2 in inhaled and exhaled air of the patient, and the method further comprises determining the efficiency of each inspiration phase in the respiratory cycle based on the measured peak-to-peak difference in the concentration of CO2 in inhaled and exhaled air of the patient, in which case, the score may be computed based on the determined efficiency of each inspiration phase in the respiratory cycle.
- a neurostimulation system may comprise an electrode lead carrying the electrode contact(s), and the neurostimulator, with the receptacle being configured for receiving the electrode lead.
- the electrode lead may carry a plurality of electrode contacts, in which case, the neurostimulation system may further comprise a clinician programmer configured for selecting the electrode contact(s) from the electrode contacts, transcutaneously communicating with the neurostimulator, and programming the control circuitry to deliver the electrical pulse train to the selected electrode contact(s).
- the neurostimulation system may further comprise a patient programmer configured for transcutaneously communicating with the neurostimulator, and toggling the neurostimulator between the OFF position and the ON position.
- the neurostimulator may further comprises a rechargeable battery contained within the case, in which case, the neurostimulation system may further comprise an external charger configured for inductively and transcutaneously charging the rechargeable battery of the neurostimulator.
- the neurostimulator will typically be implanted in the upper chest portion of the patient away from these anatomical structures, one or more leads must be used to implant the sensor(s) within these anatomical structures remote from the neurostimulator, thereby requiring additional surgical time and effort.
- the sensing circuitry 76 is used primarily to sense the respiration cycle and can, in embodiments of the invention, determine a projected onset of the inspiratory phase of the breathing cycle, or alternatively, may determine the projected onset of the expiratory phase of the breathing cycle.
- the sensing circuitry 76 is configured for detecting physiological artifacts that are caused by respiration (e.g., movement or expansion of ribcage and/or abdomen), which are proxies for respiratory phases, such as inspiration and expiration or, if no movement occurs, to indicate when breathing stops.
- the sensing circuitry 76 may sense movement of the thoracic cavity and/or detect changes in pressure/force in the thoracic cavity.
- the feedback mechanism 90 can take the form of any mechanism that can output a signal indicative of the efficacy of the treatment of OSA.
- the patient is either asleep or under general anesthesia.
- the feedback mechanism 90 comprises a temperature sensor that can be located under the nose and/or close to the mouth of the patient to measure the temperature of the inhaled and exhaled air of the patient. Since inhaled air has a lower temperature than that of the exhaled air, the temperature of the inhaled and exhaled air is a good indicator of the respiratory cycle. The temperature change between the inhaled air and the exhaled air is best illustrated in FIG.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Physiology (AREA)
- Pulmonology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Optics & Photonics (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Otolaryngology (AREA)
- Electrotherapy Devices (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15/885,618 US20180221660A1 (en) | 2017-02-01 | 2018-01-31 | Stimulator systems and methods for obstructive sleep apnea |
| US16/245,509 US20190143110A1 (en) | 2017-02-01 | 2019-01-11 | Stimulator systems and methods for obstructive sleep apnea |
| US16/812,947 US11638826B2 (en) | 2017-02-01 | 2020-03-09 | Stimulator systems and methods for obstructive sleep apnea |
| US16/992,439 US20200368526A1 (en) | 2017-02-01 | 2020-08-13 | Stimulator systems and methods for obstructive sleep apnea |
| US17/083,532 US11654284B2 (en) | 2017-02-01 | 2020-10-29 | Stimulator systems and methods for obstructive sleep apnea |
| US17/091,182 US11642529B2 (en) | 2017-02-01 | 2020-11-06 | Stimulator systems and methods for obstructive sleep apnea |
| US18/296,805 US20230241393A1 (en) | 2017-02-01 | 2023-04-06 | Stimulator systems and methods for obstructive sleep apnea |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762453311P | 2017-02-01 | 2017-02-01 | |
| US15/885,618 US20180221660A1 (en) | 2017-02-01 | 2018-01-31 | Stimulator systems and methods for obstructive sleep apnea |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US16/245,509 Continuation US20190143110A1 (en) | 2017-02-01 | 2019-01-11 | Stimulator systems and methods for obstructive sleep apnea |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| US20180221660A1 true US20180221660A1 (en) | 2018-08-09 |
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Family Applications (7)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US15/885,618 Abandoned US20180221660A1 (en) | 2017-02-01 | 2018-01-31 | Stimulator systems and methods for obstructive sleep apnea |
| US16/245,509 Abandoned US20190143110A1 (en) | 2017-02-01 | 2019-01-11 | Stimulator systems and methods for obstructive sleep apnea |
| US16/812,947 Active 2038-08-06 US11638826B2 (en) | 2017-02-01 | 2020-03-09 | Stimulator systems and methods for obstructive sleep apnea |
| US16/992,439 Abandoned US20200368526A1 (en) | 2017-02-01 | 2020-08-13 | Stimulator systems and methods for obstructive sleep apnea |
| US17/083,532 Active 2038-08-08 US11654284B2 (en) | 2017-02-01 | 2020-10-29 | Stimulator systems and methods for obstructive sleep apnea |
| US17/091,182 Active 2038-08-26 US11642529B2 (en) | 2017-02-01 | 2020-11-06 | Stimulator systems and methods for obstructive sleep apnea |
| US18/296,805 Pending US20230241393A1 (en) | 2017-02-01 | 2023-04-06 | Stimulator systems and methods for obstructive sleep apnea |
Family Applications After (6)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US16/245,509 Abandoned US20190143110A1 (en) | 2017-02-01 | 2019-01-11 | Stimulator systems and methods for obstructive sleep apnea |
| US16/812,947 Active 2038-08-06 US11638826B2 (en) | 2017-02-01 | 2020-03-09 | Stimulator systems and methods for obstructive sleep apnea |
| US16/992,439 Abandoned US20200368526A1 (en) | 2017-02-01 | 2020-08-13 | Stimulator systems and methods for obstructive sleep apnea |
| US17/083,532 Active 2038-08-08 US11654284B2 (en) | 2017-02-01 | 2020-10-29 | Stimulator systems and methods for obstructive sleep apnea |
| US17/091,182 Active 2038-08-26 US11642529B2 (en) | 2017-02-01 | 2020-11-06 | Stimulator systems and methods for obstructive sleep apnea |
| US18/296,805 Pending US20230241393A1 (en) | 2017-02-01 | 2023-04-06 | Stimulator systems and methods for obstructive sleep apnea |
Country Status (5)
| Country | Link |
|---|---|
| US (7) | US20180221660A1 (fr) |
| EP (1) | EP3576838A1 (fr) |
| AU (1) | AU2018215194B2 (fr) |
| CA (1) | CA3071628A1 (fr) |
| WO (1) | WO2018144631A1 (fr) |
Cited By (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020181123A1 (fr) * | 2019-03-06 | 2020-09-10 | Medtronic Xomed, LLC | Système de simulation de muscle lingual sensible à la position pour apnée obstructive du sommeil |
| US11167140B2 (en) * | 2020-01-24 | 2021-11-09 | Medtronic Xomed, Inc. | System and method for therapy |
| US11167127B2 (en) * | 2020-01-24 | 2021-11-09 | Medtronic Xomed, Inc. | System and method for therapy |
| US11298540B2 (en) | 2017-08-11 | 2022-04-12 | Inspire Medical Systems, Inc. | Cuff electrode |
| US11324950B2 (en) | 2016-04-19 | 2022-05-10 | Inspire Medical Systems, Inc. | Accelerometer-based sensing for sleep disordered breathing (SDB) care |
| WO2022211946A1 (fr) * | 2021-03-30 | 2022-10-06 | The Alfred E. Mann Foundation For Scientific Research | Fils d'électrode ayant des gaines de nerf et systèmes associés |
| US11491324B2 (en) | 2019-10-16 | 2022-11-08 | Invicta Medical, Inc. | Adjustable devices for treating sleep apnea, and associated systems and methods |
| US11617888B2 (en) * | 2020-11-04 | 2023-04-04 | Invicta Medical, Inc. | Implantable electrodes with remote power delivery for treating sleep apnea, and associated systems and methods |
| US11623086B2 (en) | 2020-01-24 | 2023-04-11 | Medtronic Xomed, Inc. | System and method for therapy |
| US11666755B2 (en) | 2020-01-24 | 2023-06-06 | Medtronic Xomed, Inc. | System and method for therapy |
| US11738197B2 (en) | 2019-07-25 | 2023-08-29 | Inspire Medical Systems, Inc. | Systems and methods for operating an implantable medical device based upon sensed posture information |
| US11833348B2 (en) | 2021-07-09 | 2023-12-05 | The Alfred E. Mann Foundation For Scientific Research | Electrode leads having multi-application helical nerve cuffs and associated systems and methods |
| US11964154B1 (en) | 2022-12-22 | 2024-04-23 | Invicta Medical, Inc. | Signal delivery devices to treat sleep apnea, and associated methods and systems |
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| US12311170B2 (en) | 2020-05-04 | 2025-05-27 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
| US12194290B2 (en) | 2020-09-02 | 2025-01-14 | The Alfred E. Mann Foundation For Scientific Research | Electrode leads having multi-application nerve cuffs and associated systems and methods |
| US11883668B2 (en) | 2020-11-04 | 2024-01-30 | Invicta Medical, Inc. | Implantable electrodes with remote power delivery for treating sleep apnea, and associated systems and methods |
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| US11617888B2 (en) * | 2020-11-04 | 2023-04-04 | Invicta Medical, Inc. | Implantable electrodes with remote power delivery for treating sleep apnea, and associated systems and methods |
| WO2022211946A1 (fr) * | 2021-03-30 | 2022-10-06 | The Alfred E. Mann Foundation For Scientific Research | Fils d'électrode ayant des gaines de nerf et systèmes associés |
| US12350489B2 (en) | 2021-03-30 | 2025-07-08 | The Alfred E. Mann Foundation For Scientific Research | Electrode leads having nerve cuffs and associated systems and methods |
| US11833348B2 (en) | 2021-07-09 | 2023-12-05 | The Alfred E. Mann Foundation For Scientific Research | Electrode leads having multi-application helical nerve cuffs and associated systems and methods |
| US12296172B2 (en) | 2022-02-01 | 2025-05-13 | The Alfred E. Mann Foundation For Scientific Research | Electrode leads having nerve contact elements with coil contacts and associated systems and methods |
| US11964154B1 (en) | 2022-12-22 | 2024-04-23 | Invicta Medical, Inc. | Signal delivery devices to treat sleep apnea, and associated methods and systems |
| US12246175B2 (en) | 2023-03-17 | 2025-03-11 | Invicta Medical, Inc. | Methods for positioning signal delivery devices to treat sleep apnea, and associated devices and treatments |
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Also Published As
| Publication number | Publication date |
|---|---|
| US20210038889A1 (en) | 2021-02-11 |
| WO2018144631A1 (fr) | 2018-08-09 |
| AU2018215194A1 (en) | 2019-08-15 |
| US20200368526A1 (en) | 2020-11-26 |
| CA3071628A1 (fr) | 2018-08-09 |
| EP3576838A1 (fr) | 2019-12-11 |
| AU2018215194B2 (en) | 2023-02-02 |
| US11638826B2 (en) | 2023-05-02 |
| US20210052893A1 (en) | 2021-02-25 |
| US20200206501A1 (en) | 2020-07-02 |
| US11642529B2 (en) | 2023-05-09 |
| US20230241393A1 (en) | 2023-08-03 |
| US20190143110A1 (en) | 2019-05-16 |
| US11654284B2 (en) | 2023-05-23 |
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