WO1991017706A1 - Detection d'apnee du sommeil obstructive - Google Patents

Detection d'apnee du sommeil obstructive Download PDF

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Publication number
WO1991017706A1
WO1991017706A1 PCT/US1991/003348 US9103348W WO9117706A1 WO 1991017706 A1 WO1991017706 A1 WO 1991017706A1 US 9103348 W US9103348 W US 9103348W WO 9117706 A1 WO9117706 A1 WO 9117706A1
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WO
WIPO (PCT)
Prior art keywords
tubular enclosure
subject
torso
insert
volume
Prior art date
Application number
PCT/US1991/003348
Other languages
English (en)
Inventor
Denise M. Reiten
Original Assignee
Cns, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cns, Inc. filed Critical Cns, Inc.
Publication of WO1991017706A1 publication Critical patent/WO1991017706A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • A61B5/1135—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing by monitoring thoracic expansion

Definitions

  • the present invention relates to volume change monitors for use in detecting changes of a volume enclosed thereby which would typically be that of a section of a human torso and, more particularly, to determine volume changes during respiration as an indicator of the occurrence of apneas in the human being monitored.
  • volume change monitors for use in detecting changes of a volume enclosed thereby which would typically be that of a section of a human torso and, more particularly, to determine volume changes during respiration as an indicator of the occurrence of apneas in the human being monitored.
  • a known important irregularity is the temporary cessation of breathing during sleep, i.e. a sleep apnea.
  • sleep apnea Three kinds of such sleep apneas are generally recognized in humans, these being central apneas due to problems occurring in the central nervous system, obstructive apneas due to blockages of the air passageways involved in respiration, and mixed apneas involving both of these previous kinds of apneas.
  • a desirable method of determining the occurrence of obstructive apnea is based on the measurement of volume changes in the human torso due to respiration as an analog of breathing effort changes.
  • This method avoids the need to place something directly into the subject's esophagus to directly measure structural pressure changes, which such a subject will ind to be quite uncomfortable during installation and may not tolerate it at all.
  • There are known methods for monitoring such volume changes along the torso of a subject including impedance pneumography and inductive plethys ography which are expensive methods and which to some extent pick up unwanted signals such as those accompanying cardiac events.
  • Another known method is the use of a tube about the torso at a selected location having air in the interior space thereof, and a pressure monitoring apparatus connected to that space. The volume changes of the torso at the location of the tube lead to air pressure changes in its interior space which are monitored by the pressure monitoring apparatus.
  • Another means is to have a pair of resilient material strips, or tapes, provided within the tube with a space therebetween so that a passageway is maintained by the material even though compressed by the weight of the subject's torso.
  • a satisfactory tube must have walls that are rather thin so that the tube remains sensitive to even small volume changes of the torso of the subject for reasons to be described below.
  • the tube wall material must be subject to being rather easily deformed. In these circumstances, the tossing and turning of a subject during sleep with such a tube thereabout raises a concern that the two strip portions, joined by portions of the thin wall of the tube, may be repeatedly rolled over one another into a fairly tight twist.
  • respiration volume changes reflected by corresponding pressure changes in portions of the tube on one side of such a twist, may no longer be communicated to the other side of the twist which may be the side connected to the pressure monitoring apparatus.
  • a volume change monitoring apparatus based on varying air pressure occurring inside a tube placed about the torso of a subject in response to volume changes in that torso at that location configured to assure that pressure changes occurring in any one part of the tube will be communicated throughout and so to a pressure gauge connected thereto.
  • the present invention provides a volume change sensor, for sensing volume changes in a flexible body subject to such volume changes, having an elongated tubular enclosure with a thin, deformable wall about an interior region that has a conduit tube extending therefrom to provide access to this interior region by a pressure monitor, there being an elongated insert material in the interior region that is wider than it is thick at least at some locations and formed from resiliently deformable, open cell foam.
  • An elastic belting means with a pair of opposite sides against one of which said tubular enclosure is positioned is used to wrap the tubular enclosure with the insert therein about a subject's torso to measure the volume changes thereof.
  • Two such volume change sensors can be used about a subject's torso to determine the occurrence of obstructive apneas by noting the phasing of the volume changes sensed by each.
  • Figure 1 shows a subject about ⁇ hose torso a pair of monitors embodying the present invention are positioned at selected locations
  • Figure 2 shows a view of one side of either one of the monitors of Figure 1
  • Figure 3 shows the opposite side of the monitor of Figure 2
  • Figure 4 shows a cross section view of the monitor of Figure 2
  • Figure 5 shows the cross section view of Figure 4 but under the weight of the torso of the subject in Figure 1
  • Figures 6A and 6B show results of monitoring subjects using the present invention.
  • Figure 1 shows a subject, 10, having a pair of torso volume change monitoring sensors, 11 and 12, positioned about the torso of that subject at a chest location therealong and at an abdominal location therealong, respectively.
  • Sensors 11 and 12 are each connected by a hollow pressure communication tube, 13, to a pressure monitoring apparatus, 14, containing a pressure sensor which is effectively sealed to tube 13 and which can sense pressure changes occurring in the hollow thereof.
  • a pressure monitoring apparatus 14 containing a pressure sensor which is effectively sealed to tube 13 and which can sense pressure changes occurring in the hollow thereof.
  • sensors 11 and 12 are desired to be sensitive is to permit subject 10 to have some sort of garment on between the torso and either or both of these sensors without resulting in an unacceptable pressure signal from tube 13.
  • Figure 2 shows the view of the inside of either of sensors 11 or 12 of Figure 1, that is, the side of either of sensors 11 or 12 which is facing the torso of subject 10 of that figure.
  • a slight portion of an airtight enclosure, 15, is shown exposed in Figure 2 with the remaining portions thereof being shown in dashed lines in that figure on both sides of the break therein. That break is provided so that both ends of a sensor 11 or 12 can be shown in the figure which requires a substantial portion of the middle of such sensor to be omitted from being shown there.
  • Airtight enclosure 15 is typically formed of 1.5 inches (3.8 cm) wide (if flattened) polyethylene tubing having a wall thickness of 2.0 mils (0.005 cm).
  • the interior of enclosure 15 is provided with an access to pressure monitoring apparatus 14 by hollow pressure connection tube 13 which has the wall about its hollow passageway connected to the wall of enclosure 15 in an airtight connection.
  • Pressure communication tube 13 is typically formed of flexible polyvinyl chloride tubing having its interior hollow passageway with a diameter of 0.125 inches (0.32 cm), and a passageway wall thickness of 0.125 inches (0.32 cm).
  • the primary structural member of monitors 11 and 12 to which airtight enclosure 15 is attached is formed by an elastic belt, 16, which can be stretched lengthwise and which, upon release after stretching, returns to approximately its original length.
  • an elastic belt 16 At either end of belt 16 there is provided a corresponding one of two parts of a buckle, 17 and 18 (although for pediatric subjects a "snap-together" means may alternatively be substituted) .
  • Elastic belt 16 is formed by a strong but elastic material 2.0 inches (5.1 cm) wide.
  • the back of belt 16 can be seen in Figure 3 where portions on either side of the break described in connection with Figure 2 have been separated into two levels.
  • a series of pairs of snap sockets, 19, are shown along upper level portion of belt 16 in Figure 3 at the one end thereof, and a pair of snap studs, 20, can also be seen which are inserted into a pair of unseen snap sockets.
  • Snap sockets 19 and snap studs 20 permit a greater or lesser amount of the elastic material in belt 16 to be drawn through buckle piece 17 so as to provide an adjustable length for belt 16 between buckle pieces 17 and 18.
  • Airtight enclosure 15 is shown attached to the inside of belt 16 in Figure 2 by a fabric sheathing, 21.
  • Fabric sheathing 21 is a "stretch" fabric having a weave that permits it to be stretched lengthwise to a significant extent, but with very little or no stretching in the direction of its width.
  • Fabric sheathing 21 is stitched to elastic belt 16 at the edges of each so as to form a pocket into which airtight enclosure 15 can be inserted and thereafter remain at a desired positioned along the length of belt 16 between its upper and lower edges in Figure 2.
  • FIG. 4 shows a cross section view of the sensor of Figure 2, and reveals that the interior of airtight enclosure 15 contains a resilient material insert, 24, shown as a single entity that essentially fills the cross section of the interior of enclosure 15 at the location of the cross section view. Alternatively, there could be more than one such insert placed more or less end to end with one another. A further alternative would be to fill the interior of enclosure 15 with numerous chunks or balls of the resilient material.
  • Resilient material 24 is formed of an open cell polyurethane foam of a light to medium density.
  • the open cell nature of this foam allows air flow through the material of insert 24.
  • insert 24 will tend to deform and become thinner as the open cells therein are forced closer together. This closing of the previously open cells at a location in insert 24 will tend to reduce the air flow there through the material of insert 24 which could result in pressure changes in the air within airtight enclosure 15 on one side of the squeezed part of insert material 24 not being communicated to the other side which in some situations will mean also not communicated to tube 13.
  • insert material 24 to have a cross section with a substantially longer dimension more or less parallel to elastic belt 16 compared to its dimension more or less perpendicular to belt 16 tends to assure that the added passageways occurring in the interior of enclosure 15 under compression of insert 24 are actually available for communicating pressure changes in the air therein.
  • the freed wall material of enclosure 24 is not merely wrinkled, with parts thereof folded over one another, and then pinched together against the surface of insert 24 under compression to result in closing off part of what should be a passageway.
  • this longer dimension of insert 24 parallel to belt 16 prevents twisting of portions of the monitor when subject 10 slides along the surface of the bed in which the monitoring is occurring, or rolls over in that bed, or performs other such motions.
  • pressure monitoring apparatus 14 will be able to receive pressure changes both above and below this compressed value (or bias pressure value) rather than being limited on the low pressure side by atmospheric pressure, and so will be able to monitor both increases in torso volume due to inhalations and decreases in torso volume due to exhalations at those locations beneath volume change sensors 11 and 12 on the torso of subject 10.
  • open cell foam for resilient material 24 can avoid the need in some situations of having to follow an ordered set of steps in positioning the sensors properly about the subject's torso. If the cells could not hold air, the airtight enclosure may have to be sealed to the pressure monitor before being placed about the subject since otherwise the tossing and turning, or other motions, of the subject may rather completely deflate the enclosure before such sealing. This could lead to inconvenient correction procedures or the inability to fully sense torso volume changes. Since open cell foam can hold and pass air, such problems are avoided in the sensor of the present invention even if the sensor is not sealed to the pressure monitor beforehand.
  • the ability to check both volume increases and decreases at two locations on the torso of subject 10 is important in determining the occurrence of obstructive sleep apneas.
  • the chest and abdominal volume changes have one relationship during normal sleep and breathing, but a changed relationship when an obstructive apnea occurs.
  • Figure 6A shows three graphs, the upper being the actual airflow measured in the respiratory passageway by a thermistor for purposes of confirmation of the results from monitors 11 and 12.
  • the second graph presents the pressure changes sensed by sensor 11
  • the third graph presents the pressure changes sensed by sensor 12.
  • there are regular increases and decreases in airflow measured by the thermistor and in the volume changes sensed by sensors 11 and 12 as changed internal air pressures ⁇ PRESS ⁇ :L and ⁇ PRESS 12/ respectively, corresponding to the inhalations and the exhalations during respiration by subject 10.
  • the changes sensed by sensors 11 and 12 can be seen to track one another, i.e. be in phase with one another. That is, the high peak values in each sensor signal occur at approximately the same times that high peak values occur in the other as do the low peak values.
  • the graphs are presented for another subject 10 undergoing obstructive sleep apneas.
  • the thermistor measured airflow there can be seen to have a waveform with an amplitude at some locations therein that is rising and falling substantially during normal inhalations and exhalations, but which goes to a very much smaller amplitude at some other locations indicating a lack of air flow through the respiratory passageway.
  • the torso volume changes sensed by sensors 11 and 12 as sensor internal pressures ⁇ PRESS 1X and ⁇ PRESS 12 are shown to be of substantial amplitude and again in phase with one another where the airflow data indicates normal breathing airflow.
  • the torso volume change relationships at the chest and abdomen go to small amplitudes and opposite phases with respect to one another where the airflow data indicates there is little breathing due to an obstruction.
  • the amplitudes of the volume changes (or the corresponding pressure changes in enclosures 15) are usually quite small at the occurrence of an obstruction, the sensitivity of sensors 11 and 12 is sufficient to clearly show the opposite phase effect.
  • the use of two sensors like sensors 11 and 12 permits the determination of obstructive apneas without the need for actual airflow data.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Détecteur de changements de volume (11, 12) ayant une protection tubulaire allongée (15) formée par une paroi mince déformable et comportant un tube (13) pour la connection avec un moniteur de pression (14). A l'intérieur de la protection tubulaire se trouve un matériau d'insertion allongé (24) qui est plus large qu'épais à certains endroits et qui est formé avec une mousse à cellules ouvertes déformable mais résiliente. La protection tubulaire est placée sur une ceinture élastique (16) qui est utilisée pour fixer le dispositif autour du corps d'un sujet (10) dont la respiration est surveillée; le dispositif subit les changements de volume et permet de les mesurer.
PCT/US1991/003348 1990-05-18 1991-05-14 Detection d'apnee du sommeil obstructive WO1991017706A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US525,892 1983-08-24
US52589290A 1990-05-18 1990-05-18

Publications (1)

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WO1991017706A1 true WO1991017706A1 (fr) 1991-11-28

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PCT/US1991/003348 WO1991017706A1 (fr) 1990-05-18 1991-05-14 Detection d'apnee du sommeil obstructive

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993001862A1 (fr) * 1991-07-22 1993-02-04 Cyberonics, Inc. Traitement de troubles respiratoires par stimulation nerveuse
DE102012014141A1 (de) * 2012-03-23 2013-09-26 Fritz Stephan Gmbh Vorrichtung und Verfahren zum Detektieren einer Atmungstätigkeit, Beatmungsgerät und Verfahren zum Betreiben eines Beatmungsgerätes

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4373534A (en) * 1981-04-14 1983-02-15 Respitrace Corporation Method and apparatus for calibrating respiration monitoring system
US4381788A (en) * 1981-02-27 1983-05-03 Douglas David W Method and apparatus for detecting apnea
US4602643A (en) * 1984-09-14 1986-07-29 Dietz Henry G Pneumatic breathing belt sensor with minimum space maintaining tapes
US4813428A (en) * 1986-10-22 1989-03-21 Fukuda Denshi Co., Ltd. Device for detecting breathing

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4381788A (en) * 1981-02-27 1983-05-03 Douglas David W Method and apparatus for detecting apnea
US4373534A (en) * 1981-04-14 1983-02-15 Respitrace Corporation Method and apparatus for calibrating respiration monitoring system
US4602643A (en) * 1984-09-14 1986-07-29 Dietz Henry G Pneumatic breathing belt sensor with minimum space maintaining tapes
US4813428A (en) * 1986-10-22 1989-03-21 Fukuda Denshi Co., Ltd. Device for detecting breathing

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993001862A1 (fr) * 1991-07-22 1993-02-04 Cyberonics, Inc. Traitement de troubles respiratoires par stimulation nerveuse
DE102012014141A1 (de) * 2012-03-23 2013-09-26 Fritz Stephan Gmbh Vorrichtung und Verfahren zum Detektieren einer Atmungstätigkeit, Beatmungsgerät und Verfahren zum Betreiben eines Beatmungsgerätes

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