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WO2025021909A1 - Capteur de déplacement, ceinture de capteur et système de ceinture de capteur - Google Patents

Capteur de déplacement, ceinture de capteur et système de ceinture de capteur Download PDF

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Publication number
WO2025021909A1
WO2025021909A1 PCT/EP2024/071097 EP2024071097W WO2025021909A1 WO 2025021909 A1 WO2025021909 A1 WO 2025021909A1 EP 2024071097 W EP2024071097 W EP 2024071097W WO 2025021909 A1 WO2025021909 A1 WO 2025021909A1
Authority
WO
WIPO (PCT)
Prior art keywords
displacement
sensor
free end
band
arm
Prior art date
Application number
PCT/EP2024/071097
Other languages
English (en)
Inventor
Felix KINDLER
Ulrich Kindler
Original Assignee
Revamode Ag
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 Revamode Ag filed Critical Revamode Ag
Publication of WO2025021909A1 publication Critical patent/WO2025021909A1/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
    • A61B5/103—Measuring 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 or mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
    • A61B5/1135—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing by monitoring thoracic expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring 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 or mobility of a limb
    • A61B5/1107—Measuring contraction of parts of the body, e.g. organ or muscle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0223—Magnetic field sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier

Definitions

  • the health status of a human subject is currently evaluated using methods such as spirometry and end tidal carbon dioxide measurements.
  • the respiratory status is primarily monitored through pulse oximetry, i.e., by measuring the peripheral oxygen saturation (SpO2) using pulse oximeter probe adapted for an earlobe or fingertip.
  • SpO2 peripheral oxygen saturation
  • end tidal carbon dioxide may be useful for the monitoring of anesthetised or ventilated subjects, however, it is rather inaccurate when used for non-ventilated subjects.
  • Spirometry like the use of pneumotachometers, is somewhat unreliable in that the results are substantially dependent on the effort that the subject makes during testing, and thus on other highly variable factors such as the instructions which the subject receives, understands, or is able to follow during the performance of the measurement.
  • the sensor belt adapted for sensing signals that characterize one or more breathing parameters of a human subject performing at least one breathing maneuver.
  • the sensor belt comprises (a) a band having a longitudinal dimension adapted to encircle the chest of the subject, wherein the band is essentially nonelastic.
  • the belt further comprises (bj a fastening means for directly or indirectly connecting a first locus of the band with a second locus of the band such as to fasten the band around the subject's chest; and (cj a sensing device, herein referred to as a first sensing device, which is attached to the band, this first sensing device being adapted for obtaining and transmitting signals characterizing one or more breathing parameters of the subject comprising a tidal volume (Vt), an inspiratory time (Ti), expiratory time (Te), total cycle time (Ttot), respiratory rate (RR), and/or a work of breath (WoB).
  • the first sensing device is further characterized in that it is capable of sensing a force acting on the band, wherein said force results from an expansion of the chest of the subject caused by a breathing maneuver of the subject.
  • the sensor belt comprises a second sensing device, which is adapted for sensing an electrical activity of one or more muscles involved in the breathing maneuver of the subject.
  • the disclosure provides uses of the sensor belt, such as the use for obtaining and transmitting signals characterizing one or more breathing parameters selected from Vt, Ti, Te, Ttot, RR, WoB, and/or any derivative parameter thereof; and/or signals characterizing the electrical activity of one or more muscles involved in the breathing maneuver of the subject.
  • the disclosure provides a displacement sensor comprising: a base comprising a fixed input mount; a displacement arm comprising: a fixed end fixing the displacement arm to the base, and a free end, the free end comprising: a displaceable input mount aligned with the fixed input mount, wherein the displacement arm has one degree of freedom along a displacement axis perpendicular to the displacement arm to allow substantially linear translation of the free end of the displacement arm along the displacement axis; and a sensor configured to determine displacement of the free end of the displacement arm along the displacement axis.
  • a sensor belt comprises the displacement sensor, the sensor belt further comprising: a band fastened at one end to the fixed input mount of the displacement sensor and fastened at an opposite end to the displaceable input mount, wherein the band is configured to transfer a force acting on the band to the displaceable input mount causing translation of the free end of the displacement arm along the displacement axis.
  • the sensor belt comprises a displacement sensor that is configured to determine displacement of the free end of the displacement arm along the displacement axis from the force acting on the band that is translated to the displaceable input mount.
  • a sensor belt for monitoring breathing of a subject comprises the displacement sensor, the sensor belt further comprising: a band configured for application around a chest of a subject, the band fastened at one end to the fixed input mount of the displacement sensor and fastened at an opposite end to the displaceable input mount, wherein, when the subject breathes, the band is configured to transfer forces from expansion of the subject’s chest to the displaceable input mount causing translation of the free end of the displacement arm along the displacement axis.
  • the sensor belt for monitoring breathing comprises a displacement sensor that is configured to determine displacement of the free end of the displacement arm along the displacement axis from the forces acting on the band that is translated to the displaceable input mount.
  • a sensor belt system comprises the sensor belt, the sensor belt system further comprising: a processor connected to the displacement sensor; and a power source connected to the displacement sensor.
  • the sensor belt system comprises a processor that is configured to determine one or more breathing parameters based on the output of the displacement sensor and/or the electrical sensor.
  • Figure 1 is a simplified depiction of a human subject wearing a sensor belt fasted around the chest.
  • Figure 2 depicts a section of a band of a sensor belt according to an aspect which includes a fastening means and a pretensioner.
  • Figure 3 shows an example of a first sensing device according to certain aspects.
  • Figure 4 depicts a section of a band of a sensor belt according to another aspect which includes a fastening means and a pretensioner; also shown are EMG sensors as part of an example of a second sensing device.
  • Figures 5A, 5B, and 5C depict an aspect of the first sensing device as an exemplary displacement sensor.
  • Figures 6A and 6B depict an example of a displacement sensor.
  • Figures 7A and 7B depict an example of a displacement sensor.
  • Figures 8A and 8B depict an example of a displacement sensor.
  • Figure 9 depicts an example of one or more planar coils.
  • Figure 10 depicts an example of aspects of a sensor of a displacement sensor.
  • Figures 11A and 11B depict an example of a displacement sensor.
  • Figure 12 depicts an example of aspects of a sensor of a displacement sensor.
  • Figure 13 depicts an exemplary strain gauge.
  • Figure 14 is a diagram of an exemplary bridge circuit.
  • Figure 15 depicts a sensor belt system.
  • a sensor belt is provided.
  • the sensor belt is adapted for sensing signals that characterize one or more breathing parameters of a human subject performing at least one breathing maneuver.
  • the belt comprises (a) a band having a longitudinal dimension adapted to encircle the chest of the subject, wherein the band is essentially non-elastic.
  • the belt further comprises (b) a fastening means for directly or indirectly connecting a first locus of the band with a second locus of the band such as to fasten the band around the subject's chest; and (cj a sensing device, herein referred to as a first sensing device, which is attached to the band, this first sensing device being adapted for obtaining and transmitting signals characterizing one or more breathing parameters of the subject comprising a tidal volume (Vt), an inspiratory time (Ti), expiratory time (Te), total cycle time (Ttot), respiratory rate (RR), and/or a work of breath (WoB).
  • the first sensing device is further characterized in that it is capable of sensing a force acting on the band, wherein said force results from an expansion of the chest of the subject caused by a breathing maneuver of the subject.
  • a sensor belt as provided herein enables a highly accurate assessment of the health status of a human subject, in particular the subject's pulmonary function and/or respiratory function, and allows for a very early detection of any deterioration of the patient's respiratory system, as explained in more detail below.
  • the belt comprises a band which is sufficiently long so that it can be worn around the chest of a human subject.
  • the band is flexible so that it can assume the shape of the chest's circumference.
  • the band by virtue of its material, its structure and/or its dimensions, is essentially non-elastic. This is different from elastic sensor belts and enables a more accurate measurement of the mechanical force exerted by the subject during the inspiratory phase of a breathing maneuver in which the chest experiences an expansion. Due to the band's substantial lack of elasticity, said mechanical force can be selectively measured by the first sensing device which is adapted to sense such force acting on the band.
  • essentially non-elastic means that the band does not significantly increase in length when the belt is fastened around the human subject's chest during a breathing maneuver of the subject.
  • the increase in length of the band between the first and the second locus during a breathing maneuver is not more than about 5%, wherein the basis of the percentage is the resting length of the band between the first and the second locus.
  • said increase in length is not more than about 3%, or not more than about 2%, or not more than about 1%, respectively.
  • the increase in length between the first and the second locus is not more than about 3 cm, not more than about 2 cm, or not more than about 1 cm, respectively, measured as described above.
  • band materials are generally known to a person skilled in the art.
  • woven polyester fibers as used in car or airplane safety belts may be used.
  • the band may have any suitable width, for example in the range from about 20 to about 100 mm. In other aspects, the width is from about 30 to about 80 mm, or it is about 40, 45, 50, 55, 60, 65 or 70 mm, respectively. In the context of the width of the band, the expression "about” preferably means ⁇ 5 mm.
  • the thickness of the band may be selected with an eye on the band material and its structure.
  • a thickness in the range from about 0.5 to about 3 mm is considered useful.
  • Further examples of potentially useful thicknesses are about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, or about 2 mm, respectively.
  • the expression "about” should preferably be understood as ⁇ 0.2 mm.
  • the belt comprises a fastening means for directly or indirectly connecting a first locus of the band with a second locus of the band, such that the band can be fastened around the chest of the human subject.
  • the first or the second locus is at or near one of the ends of the band, and the other locus is at or near the other end of the band.
  • the length of the band from the first to the second is sufficient to make up a large portion (for example, about 60% or more, or about 70% or more) of the circumference of the chest where the belt is fastened.
  • the fastening means may, for example, be affixed directly to the first locus at a first end of the band, and near or at the opposite end it may be indirectly attached, optionally via one or more members of the first sensing device, or vice versa.
  • the fastening means may comprise a tongue member attached to the band and a buckle member that is integrated in a housing that also holds the first sensing device.
  • the first sensing device is adapted for obtaining and transmitting signals characterizing one or more breathing parameters of the subject.
  • the sensing device is adapted to be capable of sensing a force acting on the band, said force resulting from an expansion of the chest of the subject caused by a breathing maneuver of the subject. Such force would typically act on the band in a longitudinal direction, relative to the orientation of the band.
  • the breathing parameter may be either one of a tidal volume (Vt), an inspiratory time (Ti), expiratory time (Te), total cycle time (Ttot), respiratory rate (RR), and/or a work of breath (WoB).
  • Vt is understood as the volume of air that moves into or out of the lungs of a subject per breathing maneuver when breathing normally, i.e., without making any effort to take a deep breath or the like.
  • Ti is preferably understood as the time interval during a breathing maneuver from the beginning of an inspiratory air flow to the beginning of an expiratory air flow.
  • the major duration of the inspiratory time is the time of actual positive air flow into the lungs, typically followed by a very short inspiratory pause time without air flow which forms the second phase of the Ti.
  • Te is preferably understood as the time interval during a breathing maneuver from the beginning of an expiratory air flow to the beginning of an inspiratory air flow, including a short expiratory pause time without air flow after an expiratory flow time.
  • Ttot should be interpreted as the total time of a breathing maneuver, measured, e.g., from the beginning of an expiratory air flow of a given breathing maneuver to the beginning of the inspiratory air flow of the subsequent breathing maneuver.
  • RR refers to the number of breathing maneuvers in a minute.
  • the work of breath, or WoB should in the case of a non-ventilated human subject preferably be understood as the energy required for the breathing activity of a subject, i.e., for inhaling and exhaling air or a breathing gas.
  • WoB may be expressed as work per volume unit, such as joules /liter. Alternatively, it may be expressed as a rate of work, for example as joules/min.
  • the signals obtained by the first sensing device relate to a combination of breathing parameters.
  • the same raw signals as obtained by the sensing device may be used to derive or characterize more than one breathing parameter, optionally after suitable calibration.
  • the first sensing device is adapted for obtaining signals that characterize WoB and at least one further parameter selected from Vt, Ti, Te, Ttot, and RR. Such signals may be generated in response to a force, a deflection, a motion, or a change of any of these over time.
  • the first sensing device comprises a member that is moveable or deformable by the force that acts on the band in result of the expansion of the chest of the subject when that subject performs a breathing maneuver.
  • the expression "moveable or deformable” should be interpreted as moveable and/or deformable; in other words, the respective member may be both movable and deformable by the force at the same time.
  • the moveable or deformable member In order for the moveable or deformable member to respond to the force, it is arranged between the first and the second locus of the band. More specifically, the moveable or deformable member has a first end which is affixed to the first locus of the band and a second end which is affixed to the second locus of the band.
  • the affixtures may be direct or indirect.
  • the first locus and the second locus are connected by means of a major portion of the substantially non-elastic band and also via the moveable or deformable member of the first sensing device, such as to form a belt that can be fastened around the chest of the subject, wherein the moveable or deformable member is moved or deformed in response to the expansion of the chest during a breathing maneuver.
  • the movement or deformation of the moveable or deformable member is reversed during the expiration phase of the subject's breathing maneuver.
  • the first sensing device comprises a housing which holds or accommodates the moveable or deformable member.
  • it may hold the moveable or deformable member such that one of its ends, e.g., either the first or the second end, is immovably attached to the housing, whereas the other end is movable with respect to the housing.
  • the first locus of the band, the first end of the moveable or deformable member and the housing of the first sensing device may all be affixed to one another, whereas the second locus of the band may be affixed to the second end of the moveable or deformable member but movable relative to the housing.
  • the moveable or deformable member is entirely encased by the housing, so that the locus of the band which is movable relative to the housing is at least partially insertable into the housing, for example via an opening that is arranged in the housing.
  • an opening may be shaped and dimensioned such as to provide guidance to the insertable portion of the band and to restrict or avoid lateral movement of the band.
  • a guide member may be arranged within the housing to further restrict or avoid lateral movement of the inserted portion of the band.
  • the moveable or deformable member is or comprises a spring, such as a disk spring, a helical spring, a compression spring, a torsion spring, a gas spring, or a leaf spring.
  • a spring such as a disk spring, a helical spring, a compression spring, a torsion spring, a gas spring, or a leaf spring.
  • two or more springs of the same type or of different types may be combined into the moveable or deformable member.
  • the spring(s) may be made of any suitable material, such as metals, polymers, or composite materials such as fiber-reinforced composites.
  • the moveable or deformable member is or comprises a leaf spring. In some preferred versions of the leaf spring, at least two leaves are present, in particular two metal leaves. In further aspects, the moveable or deformable member is a leaf spring comprising two stainless steel leaves. Furthermore, the moveable or deformable member may be a leaf spring comprising two or more metal (such as stainless steel) leaves that are attached to one another such as to form a four-bar linkage. As used herein, a four-bar linkage is a closed-chain movable linkage comprising four members, sometimes referred to as bars or links, that are connected in a loop by four joints.
  • the joints are preferably configured such that the links move in parallel planes, thereby forming a planar four-bar linkage.
  • Two of the four links or bars may be represented by two leaves of the leaf spring, and the other two are auxiliary links. This type of assembly is advantageous in that it prevents or minimizes the lateral movement of the leaves.
  • the first sensing device preferably comprises a transducer adapted to generate an electrical signal in response to the movement or deformation of the movable or deformable member.
  • a transducer is generally understood as a device that is capable of converting a signal in one form of energy to a signal in another.
  • the transducer may be adapted to convert a mechanical signal based on the movement and/or deformation of a leaf spring into an electrical signal which may then be transmitted and processed.
  • the transducer is adapted to generate the electrical signal in the absence of friction with the movable or deformable member. Such arrangement brings about the advantage of reduced noise associated with the electrical signals generated by the transducer.
  • the electrical is generated without direct contact between the transducer and the movable or deformable member.
  • a contactless transducer device which has an inductive sensor comprising at least one coil wherein each coil is configured with a helicoidal conductor disposed on a plane and having two flat surfaces, one of said two flat surfaces forming a measuring surface which variously covers a measuring object, arranged at a distance, according to movement thereof parallel to said measuring surface.
  • said sensor electronics system provides an alternating current to said inductive sensor and evaluates changes in the alternating current caused by the measuring object.
  • the measuring object is guided at a constant distance over the surface of the flat coil.
  • the sensor electronics system of this devices is formed for detecting changes in attenuation due to the varying area of the flat coil covered by the measuring object.
  • the measuring object that influences the measuring surface is electrically conductive, or the measuring object has an electrically conductive target or measuring collar, and covers a coil area of the flat coil that can be predetermined geometrically as a function of the position of the target or measuring collar.
  • the device is further characterized in that a rectangular measuring surface is diagonally divided into two triangular flat coils, whereby their inductances and ohmic resistors form half of a bridge circuit, the other half of which is complemented with resistors, to produce a full bridge.
  • the movable or deformable member is or comprises a leaf spring, such as a spring comprising two or more metal leaves, wherein at least one of the leaves is equipped with at least one strain gauge.
  • Strain gauges are not contactless, but they work without creating undesirable friction. Moreover, they primarily respond to the deformation of a piece to which they are attached, e.g., a leaf spring.
  • two or more strain gauges are affixed to a surface of the movable or deformable member, such as to a surface of a metal leaf comprised in a leaf spring.
  • the strain gauges should be arranged or affixed such that they respond to a deformation of the leaf in a longitudinal direction.
  • the longitudinal direction is the same as the longitudinal direction of the band, and is the same direction in which the force resulting from the expansion of the chest of the subject caused by a breathing maneuver acts on the movable or deformable member.
  • one or more strain gauges are used as transducers for generating electrical signals in response to a mechanical deformation of one or more metal leaves, these may also be arranged in a double bending beam configuration. In such assembly, two spring elements (i.e., leaves or beams) are coupled via rigid elements.
  • the strain gauges may be affixed to the surface of at least one of the leaves, optionally at a location of maximum strain of the leaf, but more preferably at a position where the maximum strain of the strain gauge is not exceeded.
  • the first sensing device comprises a transmitter being adapted for transmitting the electrical signal generated by the transducer by wire or wirelessly.
  • the signal may be transmitted directly or after initial signal processing, i.e., by amplification or filtering, which may be performed by further electronic elements arranged as part of the sensing device, e.g., within the optional housing.
  • Signal transmission may typically occur from the sensing device to an external control unit which is not part of the sensor belt as claimed herein.
  • the control unit may indeed be incorporated in the sensor belt.
  • the control unit may comprise a central processing unit and other electronic devices necessary to perform further signal processing such that the breathing parameters described above, or any parameters derived from these, are calculated.
  • the control unit may further comprise, or be associated with, a display for displaying one or more parameters, their change over time, or messages relating to the status of the subject or the function of the sensor belt.
  • the first sensing device may be arranged as part of the belt such that it bridges or connects the first and the second locus.
  • the fastening means is arranged for connecting the first locus with the second locus via the first sensing device.
  • the fastening means may be associated with or integrated within the housing of the first sensing device.
  • the housing of the first sensing device comprises a first end which is fixated with respect to the first locus of the band and also with the first end of the moveable or deformable member, and a second end which is moveable with respect to the second locus of the band and the second end of the moveable or deformable member.
  • the second locus of the band may be connectable to the second end of the moveable or deformable member, e.g., by the fastening means or a member thereof.
  • a tongue member may be affixed to the band at its second locus
  • a buckle member may be affixed to the second end of the moveable or deformable member, wherein the tongue and the buckle are firmly but reversibly connectable.
  • the buckle member is affixed to the moveable or deformable member via a portion of the non-elastic band.
  • the band may be interrupted by the fastening means.
  • the sensor belt comprises a pretensioner for adjusting the longitudinal extension of the band to the circumference of the chest of the subject.
  • the pretensioner may be a simple, manually adjustable means for preadjusting the effective length of the band, for example a slide, such as a webbing buckle slide.
  • Providing electrical power to the first sensing device may be achieved by connecting the sensing device with an external power source, e.g., using a suitable power cord.
  • the sensor belt is arranged for accommodating an internal power source.
  • the sensor belt may comprise a battery holder.
  • Such battery holder may advantageously be arranged in the housing which also holds the moveable or deformable member, i.e., the housing of the first sensing device.
  • the sensor belt comprises a second sensing device, which is preferably adapted for sensing an electrical activity of one or more muscles involved in the breathing maneuver of the subject.
  • This further sensing device preferably comprises at least one electronic amplifier and at least three skin electrodes arranged for performing surface electromyography (EMG).
  • EMG surface electromyography
  • the electrodes are connected to the amplifier by wires dimensioned to allow the positioning of the electrodes on the skin of the subject independently of the band, i.e., independently of the exact position of the band on the chest.
  • the amplifier may optionally be arranged in the housing of the first sensing device.
  • Electromyography involves the detection of the electric potential generated by muscle cells when these are electrically or neurologically activated.
  • EMG may be performed using needle sensors, but in the context of the present aspects the use of skin electrodes, or surface electrodes, is preferred.
  • the sensor belt also comprising the second sensing device is particularly advantageous as it allows for simultaneous analysis and correlation of breathing parameters derived from mechanical signals as obtained through the first sensing device with electrical signals from muscles involved in breathing which reflect the degree of physiological stimulation that is required for producing the breathing parameters.
  • Such analysis and correlation have been found to permit a more accurate evaluation of the health status of a human subject, in particular the status of the respiratory system.
  • the inventors have discovered that it also enables an earlier detection of a deterioration of the health status, compared to conventional monitoring techniques.
  • the human subject may preferably be a patient receiving postoperative care and/or intensive care.
  • the subject may be a patient at risk of developing a pulmonary complication, such as a postoperative pulmonary complication.
  • at risk should be understood as being at an increased risk compared to a healthy human subject.
  • the disclosure is directed to the use of the sensor belt for monitoring a subject. More specifically, the sensor belt as described above may be used for obtaining and transmitting signals characterizing one or more breathing parameters of a human subject.
  • the breathing parameters may be selected from Vt, Ti, Te, Ttot, RR, WoB, and/or any derivative parameter thereof.
  • some of the preferred aspects are directed to the use of the sensor belt comprising a second sensing device as disclosed above for obtaining and transmitting signals that relate to the electrical muscle activity, in particular of one or more muscles involved in breathing.
  • the disclosure relates to a method of evaluating signals generated by the sensor belt.
  • Such method comprises: continually and simultaneously (i) receiving, from the first and/or the second sensing device, and (ii) processing a plurality of signals characterizing one or more breathing parameters selected Vt, Ti, Te, Ttot, RR, WoB, and/or electrical muscle activity.
  • the processing comprises the calculation of one or more statistical variability measures of Vt, Ti, WoB, electrical muscle activity or of any ratios thereof.
  • continual processing should be interpreted broadly such as to encompass continuous as well as repetitive or iterative processing, such as when a particular calculation step is repeated in certain time intervals, such as every second or every 5 seconds, for example.
  • the period over which the continual and simultaneous receiving and processing of the signals occurs may be selected with an eye on the specific situation. Typically, the period is at least about one minute. For example, the period may be set in the range from about one minute to about 14 days. In some further preferred aspects, the period is from about one hour to about 7 days. If the method is carried out during postoperative and/or intensive care, the period over which the method is performed may essentially cover the period over which the subject receives postoperative and/or intensive care. Alternatively, the period which the method is performed extends over at least about 50%, 60%, 70%, 80% or 90% of the duration of the postoperative and/or intensive care.
  • the continual processing of the signals received from the first sensing devices comprises the continual calculation of a variability measure of Vt and/or of the ratio Vt/Ti, such as the coefficient of variation.
  • the method further comprises a step of continually displaying said variability measurers] on an electronic display, for example in the form of number values or in the form of a graph depicting the variability measurers] over time.
  • the continual processing of the signals comprises performing Fast Fourier Transformation (FFT) of one or more of the signals received from the first sensing device.
  • FFT Fast Fourier Transformation
  • it may further comprise the continual calculation of a correlation measure indicating the degree of correlation of the FFT- transformed signals with previously acquired and FFT-transformed reference signals.
  • the results of the continual calculations may be displayed on a display in real time or with minimal delay. The inventors have found that this use of FFT may significantly enhance the ability of an informed observer to recognize the onset of a deterioration of the status of the monitored human subject, compared to conventional monitoring techniques.
  • the continual processing comprises calculating, from signals received from the first sensing device and from signals received from the second sensing device, a ratio of at least one of the breathing parameters to a parameter describing said electrical activity.
  • a particularly relevant ratio reflecting the status of the monitored subject may be the ratio of WoB, as calculated from signals obtained from the first sensing device, to a parameter describing the electrical activity of one or more muscles involved in breathing, based on signals obtained from the second sensing device, or vice versa. It has been found by the inventors that such ratio is particularly sensitive in evaluating the status of a human subject or in the early detection of a status change.
  • a first sensing device attached to the band the first sensing device being adapted for obtaining and transmitting signals characterising one or more breathing parameters of the subject comprising a tidal volume (Vt), an inspiratory time (Ti), expiratory time (Te), total cycle time (Ttot), respiratory rate (RR), and/or a work of breath (WoB), wherein the first sensing device is capable of sensing a force acting on the band, said force resulting from an expansion of the chest of the subject caused by a breathing manoeuvre of the subject.
  • Vt tidal volume
  • Ti inspiratory time
  • Te expiratory time
  • Ttot total cycle time
  • RR respiratory rate
  • WoB work of breath
  • the sensor belt of item 1 wherein the first sensing device comprises a member that is moveable or deformable by said force, said member having a first end and a second end, wherein the first end is affixed to the first locus and the second end is affixed to the second locus of the band; and wherein the first sensing device optionally comprises a housing which holds the moveable or deformable member.
  • the sensor belt of item 1 or 2 wherein the moveable or deformable member is or comprises a leaf spring, preferably comprising one or more leaves, and wherein the two or more leaves are preferably attached to one another such as to form a four-bar linkage.
  • the first sensing device comprises a transducer adapted to generate an electrical signal in response to the movement or deformation of the movable or deformablel9 member, and wherein the transducer is preferably adapted to generate the electrical signal without direct contact to the movable or deformable member.
  • the transducer comprises: an inductive sensor comprising at least one coil wherein each coil is configured with a helicoidal conductor disposed on a plane and having two flat surfaces, one of said two flat surfaces forming a measuring surface which variously covers a measuring object, arranged at a distance, according to movement thereof parallel to said measuring surface; wherein said sensor electronics system provides an alternating current to said inductive sensor and evaluates changes in the alternating current caused by the measuring object; wherein the measuring object is guided at a constant distance over the surface of the flat coil; wherein the sensor electronics system is formed for detecting changes in attenuation due to the varying area of the flat coil covered by the measuring object; wherein the measuring object that influences the measuring surface is electrically conductive, or the measuring object has an electrically conductive target or measuring collar, and covers a coil area of the flat coil that can be predetermined geometrically as a function of the position of the target or measuring collar; and wherein a rectangular measuring surface is diagonally divided into two triangular flat coils
  • the sensor belt of item 4 or 5 wherein the transducer comprises one or more strain gauges affixed to the movable or deformable member.
  • the sensor belt of any one of the preceding items further comprising: a pretensioner for adjusting the longitudinal extension of the band to the circumference of the chest of the subject; and/or a battery holder, wherein the battery holder is optionally arranged in the housing which holds the moveable or deformable member.
  • the sensor belt of any one of the preceding items comprising a second sensing device, said second sensing device adapted for sensing an electrical activity of one or more muscles involved in the breathing manoeuvre of the subject; and wherein the second sensing device preferably comprises at least one electronic amplifier and at least three skin electrodes arranged for performing surface electromyography (EMG), wherein the electrodes are connected to the at least one amplifier by wires dimensioned to allow the positioning of the electrodes on the skin of the subject independently of the band, wherein the amplifier is preferably arranged within the housing of the first sensing device.
  • EMG surface electromyography
  • processing comprises - performing Fast Fourier Transformation [FFT] of one or more of the signals received from the first sensing device, and - calculating a correlation measure indicating the degree of correlation of the FFT-transformed signals with previously acquired and FFT-transformed reference signals; and optionally - calculating from signals received from the first sensing device and from signals received from the second sensing device a ratio of at least one of the breathing parameters to a parameter describing said electrical activity
  • FFT Fast Fourier Transformation
  • the first sensing device may be a displacement sensor.
  • the physical structure and arrangement of the displacement sensor provides numerous advantages, which may also be described above in detail with regard to the first sensing device.
  • the displacement sensor is able to output a highly accurate and low noise signal for measuring displacement as there is no inter-member friction between the structures of the displacement sensor.
  • the mechanical isolation of relevant input forces again due to the physical structure and arrangement of the displacement sensor, allow for a system with no or negligible mechanical hysteresis.
  • the displacement sensor comprises a base comprising a fixed input mount; a displacement arm comprising: a fixed end fixing the displacement arm to the base, and a free end, the free end comprising: a displaceable input mount aligned with the fixed input mount, wherein the displacement arm has one degree of freedom along a displacement axis perpendicular to the displacement arm to allow substantially linear translation of the free end of the displacement arm along the displacement axis; and a sensor configured to determine displacement of the free end of the displacement arm along the displacement axis.
  • the base of the displacement sensor provides a frame of reference for the various features of the displacement sensor, including the orientation of the various features, as well as a physical structure upon which other features are attached or integrally formed.
  • the base may be part of the housing described above or may be a separate structure provided within the housing.
  • the base may be formed of a material that is not subject to plastic deformation due to forces acting on inputs of the displacement sensor or forces acting on the displacement sensor in general.
  • the base may be formed by one or more metals, plastics, ceramics, and/or composite materials.
  • the base comprises a fixed input mount.
  • the fixed input mount may be a separate structure attached to the base or integrally formed, i.e., monolithically, with the base so that it is immobile and has a fixed position relative to the base.
  • External inputs that transfer a physical force can be attached, e.g., releasably fastened or irreversibly fastened, to the fixed input mount.
  • a releasably fastened external input may be a structure that allows for a firm and fixed connection when attached, but has a structure that allows for the reversible disconnection of the external input to the fixed input mount.
  • an irreversibly fastened external input cannot be removed without resulting in physical damage to the external input or the fixed input mount.
  • the displacement sensor also comprises a displacement arm, also referred to herein as a moveable or deformable member of the first sensing device.
  • the displacement arm extends from a fixed end, also referred to herein as a first end of the moveable or deformable member, to a free end, also referred to herein as a second end of the moveable or deformable member.
  • the fixed end of the displacement arm fixes the displacement arm to the base so that the displacement arm, i.e., the free end of the displacement arm, has one degree of freedom along a displacement axis perpendicular to the displacement arm to allow substantially linear translation of the free end of the displacement arm along the displacement axis.
  • the one degree of freedom refers to the six degrees of freedom of a body with reference to an X-axis, Y-axis, and Z-axis including translation along or relative to any of the respective axes and rotation along or relative to any of the respective axes.
  • the free end of the displacement arm has only one degree of translational freedom along a single axis referred to herein as the displacement axis.
  • the displacement arm is an elongate structure extending from the free end to the fixed end, the structure may have an overall deflection profile that would have an arcuate or curvilinear shape from one maximum deflection point to another maximum deflection point (elastic or plastic); however, the substantially linear translation of the free end of the displacement arm refers to a target area for measurement of displacement in which the movement of the free end of the displacement arm follows a path that is substantially linear, e.g., the deflection profile within the target area has a large enough radius of curvature so that for measurement purposes, the movement of the free end is effectively linear.
  • the physical parameters (for example, dimensions, shape, and material properties and the interaction therebetween) of the displacement arm ensure the substantially linear translation of the free end of the displacement arm along the displacement axis within the target area.
  • the target area may be determined by a predetermined maximum displacement length that the displacement sensor is configured to measure/determine.
  • guiding structures are not required that would delineate a single axis by physically blocking non-axis movement of a measurement target and, thus, result in friction between the measurement target and the guiding structures.
  • the displacement sensor may have one or more stoppers that prevent translation of the free end of the displacement arm beyond the target area of measurement and/or to positions that may result in plastic deformation of the displacement arm.
  • the one or more stoppers may be fixed to the base, may be fixed to the housing, and/or may be integrally formed with the base and/or the housing.
  • the one or more stoppers are configured to physically block or restrict movement of the free end of the displacement arm in one or both directions along the displacement axis.
  • the free end of the displacement arm comprises a displaceable input mount that is aligned with the fixed input mount.
  • the displaceable input mount and the fixed input are aligned so that forces acting on one or both mounts do not result in a moment of force that could result in torque or rotation of the displacement sensor, which would also decrease the accuracy of the displacement sensor.
  • the displacement input mount and fixed input mount may be aligned so that forces acting on one or both mounts are aligned with the displacement axis.
  • the displaceable input mount may be a separate structure attached to the free end of the displacement arm or integrally formed, i.e., monolithically, with the free end so that it is immobile and has a fixed position relative to the free end of the displacement arm.
  • External inputs that transfer a physical force can be attached, e.g., releasably fastened or irreversibly fastened, to the displaceable input mount.
  • a releasably fastened external input may be a structure that allows for a firm and fixed connection when attached, but has a structure that allows for the reversible disconnection of the external input to the displaceable input mount.
  • an irreversibly fastened external input cannot be removed without resulting in physical damage to the external input or the displaceable input mount.
  • the free end of the displacement arm is not in physical contact with any other structures of the displacement sensor, i.e., there is a gap between the free end of the displacement arm and any other structures of the displacement sensor that would result in friction when moving.
  • This allows for frictionless movement (excluding internal friction) of the free end of the displacement arm due to forces acting on the displaceable input mount.
  • the mechanical force acting on the displaceable input mount is accurately communicated as translation of the free end of the displacement arm without any losses due to friction.
  • the displacement arm may comprise a leaf spring (also discussed elsewhere herein) extending from the fixed end to the free end, the leaf spring cantilevered at the fixed end, i.e., along a longitudinal axis / longest dimension of the leaf spring only one end — the fixed end — of the leaf spring is fixed relative to the base with the free end not in physical contact with any other structures of the displacement sensor that would result in friction when moving, with a planar shape of the leaf spring oriented perpendicular to the displacement axis.
  • a leaf spring also discussed elsewhere herein
  • the free end of the leaf spring can translate along the displacement axis with the leaf spring geometry oriented to allow deflection in a direction with the highest elasticity of the leaf spring while simultaneously inhibiting or impeding deflection in other directions, e.g., perpendicular to the displacement axis and aligned with the planar shape of the leaf spring.
  • the planar shape of the leaf spring deflects in an “S” shape when viewed along the planar shape of the leaf spring.
  • leaf spring parameters e.g., spring constant, shape, dimensions, and the interactions therebetween, are selected to minimally or negligibly act on input forces to the displaceable input mount to ensure the mechanical force acting on the displaceable input mount is accurately communicated as translation of the free end of the displacement arm along the displacement axis eliminating or reducing force components in other directions.
  • a leaf spring may have dimensions of a length in a range of 10 to 200 mm, optionally in a range of 50 to 150 mm, preferably 80 mm; a width in a range of 1 to 50 mm, optionally in a range of 10 to 20 mm, preferably 16 mm; a thickness in a range of 0.1 to 1.0 mm, optionally in a range of 0.1 to 0.3 mm, preferably 0.25 mm.
  • the leaf spring may have a linear spring constant.
  • the leaf spring may have a non-linear spring constant, e.g., a variable rate spring constant that varies based on deflection of the leaf spring.
  • the non-linear spring rate may be progressive, i.e., increasing with deflection or digressive, i.e., decreasing with deflection.
  • the spring constant may have a non-linear spring constant in accordance with Table 1.
  • the leaf spring may comprise one or more metals and/or metal alloys, e.g., spring steel, such as a spring steel conforming to one or more of the standards BS 1449, CS 80, and BS 970.
  • the displacement arm may further comprise a mount member fixed to the base; a plurality of leaf springs extending from the fixed end to the free end, the plurality of leaf springs cantilevered at the fixed end of the displacement arm from the mount member, with a planar shape of each leaf spring of the plurality of leaf springs oriented perpendicular to the displacement axis and in parallel to one another, and a connecting member attached to the free end of the plurality of leaf springs for translation of the free end of the plurality of leaf springs in unison.
  • each leaf spring of the plurality of leaf springs may be considered to be in parallel planes, i.e., the planar shapes of the plurality of leaf springs are aligned to be substantially parallel.
  • the plurality of leaf springs may be distanced from each other by a range of 1 to 100 mm, optionally in a range of 10 to 30 mm, preferably by 26 mm.
  • the mount member may be a separate structure attached to the base or integrally formed, i.e., monolithically, with the base so that it is immobile and has a fixed position relative to the base.
  • the mount member is configured so that is the only structure of the displacement arm that is in contact with the base or other structures of the displacement sensor that could result in friction when the displacement arm is moving.
  • the mount member may be composed of a rigid or substantially non-flexible material, i.e., forces acting on the displacement arm should not result in deflection or other movement of the mount member.
  • the connecting member attaches the free end of the plurality of leaf springs together so that the free end of the plurality of leaf springs translate in unison.
  • the connecting member may be composed of a rigid or substantially non-flexible material, i.e., forces acting on the displacement arm should not result in deflection or other movement of the connecting member.
  • the plurality of cantilevered leaf springs are configured as the structures of the displacement arm intended to deflect with substantially linear translation of the free end of the plurality of leaf springs.
  • the planar shape of the individual leaf springs deflect in parallel “S” shapes when viewed along the planar shapes of the leaf springs.
  • each leaf spring of the plurality of leaf springs With the planar shape of each leaf spring of the plurality of leaf springs oriented perpendicular to the displacement axis and in parallel to one another, as well as cantilevered at the fixed end, the free end of the leaf spring can translate along the displacement axis with the leaf spring geometry oriented to allow deflection in a direction with the highest elasticity of the leaf spring while simultaneously inhibiting or impeding deflection in other directions, e.g., perpendicular to the displacement axis and aligned with the planar shape of the leaf spring.
  • this configuration further simultaneously inhibits or impedes torsional/rotational movement of the displacement arm and is more stable in comparison to one leaf spring.
  • leaf spring parameters e.g., spring constant, shape, dimensions, and the interactions therebetween, are selected to minimally or negligibly act on input forces to the displaceable input mount to ensure the mechanical force acting on the displaceable input mount is accurately communicated as translation of the free end of the displacement arm along the displacement axis eliminating or reducing linear and torsional force components in other directions.
  • the displacement sensor further comprises a sensor configured to determine displacement of the free end of the displacement arm along the displacement axis.
  • the sensor may include any of the sensor circuitry referred to elsewhere herein, such as the transducer, contactless transducer, transmitter, electronic component, inductive sensing element, and/or iron core piece, but is not limited thereto, i.e., the sensor refers to any electrical circuity described elsewhere herein that is configured to output an electrical signal based on the mechanical inputs to the displacement sensor as a whole, e.g. from determining/ measuring displacement of the free end of the displacement arm of the displacement sensor as well as any electrical circuitry that implement this function.
  • the senor may further comprise a controller; an integrated circuit; electrical hardware and components, such as, but not limited to one or more resistors, one or more capacitors, one or more coils, one or more diodes, one or more amplifiers, one or more regulators, etc.; software, firmware, and any combination thereof.
  • the sensor may comprise a measurement target attached to the free end of the displacement arm for substantially linear co-translation of the measurement target along the displacement axis, a sensing circuit attached to the base and spaced apart from the free end of the displacement arm and the measurement target to form a gap between the sensing circuit and the measurement target as well as the free end of the displacement arm, and wherein the sensing circuit is configured to determine translation of the measurement target along the displacement axis.
  • the measurement target may be a separate structure or a predetermined portion of the free end of the displacement arm that the sensing circuit is able to sense, i.e., determine and/or measure, any translation of the measurement target.
  • the measurement target is attached, i.e., fixed, to the free end of the displacement arm so that any translation of the free end of the displacement arm also results in the substantially linear co-translation of the measurement target along the displacement axis.
  • the gap may be in a range of 0.1 to 10 mm, optionally 0.1 to 1.0 mm or 0.5 to 1.0 mm, preferably 0.5 mm or 1.0 mm.
  • the sensing circuit is configured to determine movement of the measurement target in a frictionless manner, i.e., without direct physical contact with the measurement target.
  • the sensing circuit may be an optical sensor that is able to optically distinguish the measurement target and determine movement of the measurement target via photosensitive receptors.
  • the sensing circuit may be an electrical field sensor with the measurement target causing a measurable variance in an electrical field between the sensing circuit and the measurement target to determine movement of the measurement target.
  • the sensing circuit may be a magnetic field sensor with the measurement target causing a measurable variance in a magnetic field between the sensing circuit and the measurement target to determine movement of the measurement target.
  • the sensing circuit may be a combination of an optical sensor, an electrical field sensor, and/or a magnetic field sensor.
  • the sensing circuit may be an electromagnetic sensor with the measurement target causing a measurable variance due to the interactive effect of magnetic and electrical systems to determine movement of the measurement target.
  • the sensing circuit may, for example, be an eddy current sensor or an inductive sensor.
  • the measurement target may comprise an optical pattern and/or comprise an optically distinguishable material and/or color, e.g., contrasting colors and/or a phosphorescent material.
  • the measurement target may comprise an electrically conductive material.
  • the measurement target may comprise an electrical component, e.g., having an electrically configured structure to capacitively interact with another electrically configured structure in the sensing circuit, such as a capacitor plate or a capacitive comb structure.
  • the measurement target may comprise a metal, e.g., aluminum, and/or a metal alloy, e.g., brass.
  • the measurement target may comprise a ferromagnetic material, e.g., steel.
  • the sensing circuit may comprise one or more planar coils that are arranged parallel to the displacement axis with the one or more planar coils at a fixed distance from the displacement axis along which the measurement target is configured to translate with the free end of the displacement arm.
  • the size of the gap between the sensing circuit and the measurement target, as well as the free end of displacement arm is constant along the displacement axis.
  • An area covered by the one or more planar coils may define the target area along the displacement axis over which the displacement sensor is configured to measure displacement.
  • the physical structure of the displacement sensor ensures the measurement target moves along the displacement axis at a fixed distance to the one or more planar coils thereby ensuring a constant effect on the one or more planar coils.
  • the measurement target may comprise a ferromagnetic material.
  • the one or more planar coils may comprise an electrically conductive material.
  • the electrically conductive material may comprise one or more metals, e.g., may comprise copper or may comprise an alloy, e.g., a copper alloy.
  • the one or more planar coils may be arranged on a substrate or carrier, which may comprise a material that is not electrically conductive relative to the electrically conductive material of the one or more planar coils.
  • the material of the substrate or carrier may comprise, for example, a resin, such as an epoxy resin, silicon, a ceramic, a glass, and/or a composite material, such as FR4.
  • the one or more planar coils may comprise a plurality of planar coils arranged in parallel planes.
  • the plurality of planar coils arranged in parallel planes may be electrically isolated from one another and vertically aligned with one respective coil stacked above another coil, i.e., stacked.
  • the stacked coil system can reduce the required power input into the sensing circuit due to the stacked coil system having a higher impedance. This is particularly advantageous, for example, when the displacement sensor is connected to a power source with a fixed amount, e.g., a battery, thereby prolonging the operational time of the displacement sensor.
  • the turns of the one or more planar coils may be arranged in a triangular shape and the measurement target may have a right-angled quadrilateral prism shape.
  • the measurement target may have a narrow rectangular profile facing the one or more planar coils with the greatest length of the measurement target arranged perpendicular to the displacement axis and a smallest dimension of the right-angled quadrilateral prism shape arranged in parallel with the displacement axis.
  • the greatest length of the measurement target may extend beyond the greatest width of the planar coils (i.e., as one or more planar coils or two or more planar coils) to compensate for any curvature in the substantially linear pathway of the free end of the displacement arm by ensuring the greatest width of the planar coils is always covered by the measurement target.
  • the narrow rectangular profile may have adjacent sides, e.g., length and width, with a ratio of approximately 4:1.
  • the narrow rectangular profile may have a length in a range of 1 to 100 mm, optionally in a range of 10 to 30 mm, preferably 20 mm, and a width in a range of 1 to 25 mm, optionally in a range of 1 to 10 mm, preferably 5 mm.
  • the sensing circuit may comprise a bridge circuit, e.g., a Wheatstone bridge circuit, with the planar coils forming a half-bridge of the bridge circuit.
  • the planar coils may be configured to create high frequency electromagnetic fields that induce eddy currents in the measurement target moving above the planar coils, thereby causing a damping effect in the high frequency electromagnetic fields that is determined by the sensing circuit.
  • the sensing circuit may further comprise a ferromagnetic structure on a side of the planar coils opposite to the measurement target.
  • the ferromagnetic structure reduces interference in the planar coils from electromagnetic fields opposite to the side of the planar coils and improves the accuracy of the sensing circuit.
  • the senor may comprise one or more strain gauges (described above in further detail) attached to the displacement arm.
  • the one or more strain gauges may be attached to a leaf spring of the displacement arm, preferably to the planar surface of a leaf spring of the displacement arm.
  • a first strain gauge may be attached to the leaf spring closer to the fixed end than the free end and a second strain gauge may be attached to the leaf spring closer to the free end than the fixed end.
  • one of the first strain gauge and the second strain gauge is attached to an area of the leaf spring under compression and the other strain gauge is attached to an area of the leaf spring under tension during deflection of the leaf spring, i.e., here, the relevant translation of the free end along the displacement axis.
  • the measurement areas of the first strain gauge and the second strain gauge may be arranged to be equidistant from a neutral zone of the leaf spring.
  • the neutral zone of the leaf spring is a region of the leaf spring where the compressive and tensile stress transitions.
  • the first and second strain gauges may be attached to different leaf springs of the plurality of leaf springs.
  • the sensor may comprise a bridge circuit, e.g., a Wheatstone bridge circuit, with the first strain gauge and the second strain gauge forming a half-bridge of the bridge circuit.
  • the bridge circuit e.g. a Wheatstone bridge circuit
  • the bridge circuit may be formed by four strain gauges, with a third and fourth strain gauge attached to another leaf spring of the plurality of leaf springs in a mirrored fashion to the first and second strain gauges.
  • the sensor comprising one or more strain gauges attached to the displacement arm allows for frictionless translation of the free end of the displacement arm as the free end of the displacement arm is not in contact with other structures of the displacement sensor that would cause friction when moving. While the one or more strain gauges may have wires connecting the respective strain gauges to additional sensing circuitry, the geometry and properties of the wires may be selected to negligibly effect movement of the displacement arm, e.g., thin or small gauge wires.
  • the displacement sensor in accordance with the various aspects of the disclosure, may be incorporated into a sensor belt.
  • the sensor belt may further comprise a band (described elsewhere in further detail) fastened at one end to the fixed input mount of the displacement sensor and fastened at an opposite end to the displaceable mount at the free end of the displacement arm of the displacement sensor.
  • the band is configured to transfer a force acting on the band to the displaceable input mount causing translation of the free end of the displacement arm along the displacement axis.
  • the displacement sensor is configured to determine displacement of the free end of the displacement arm along the displacement axis from the force acting on the band that is translated to the displaceable input mount.
  • an advantageous aspect of the disclosure is the application of the sensor belt for monitoring breathing and/or breathing parameters of a subject.
  • the band is thus configured for application around a chest of a subject with the band fastened at one end to the fixed input mount of the displacement sensor and fastened at an opposite end to the displaceable input mount.
  • the band is configured to transfer forces from expansion of the subject’s chest to the displaceable input mount causing translation of the free end of the displacement arm along the displacement axis; during exhalation, the subject’s chest contracts and the forces acting on the band reduce and the displacement arm of the displacement sensor returns to an initial position of the displacement arm.
  • the displacement sensor is configured to determine displacement of the free end of the displacement arm along the displacement axis from the forces acting on the band that is translated to the displaceable input mount due to the subject’s breathing.
  • the displacement sensor may output a sinusoidal-like wave that is dependent on the input of the subject’s breathing.
  • the sensor belt may further comprise an electrical sensor, also referred to herein as a second sensing device.
  • the electrical sensor comprises a plurality of electrodes and may be configured to determine an electrical potential difference between the plurality of electrodes.
  • the electrical sensor may be an electromyography sensor.
  • the electrical sensor may be co-located in a housing that also comprises the displacement sensor. Alternatively, the electrical sensor may be located on the band at a position different from the displacement sensor.
  • the sensor belt may be part of a sensor belt system.
  • the sensor belt system may further comprise a processor connected to the displacement sensor.
  • the processor is configured to receive output from the displacement sensor and/or the electrical sensor and/or determine one or more breathing parameters (discussed elsewhere herein in detail) based on the output of the displacement sensor and/or the electrical sensor.
  • the processor may be configured to perform the processing methods described herein.
  • the sensor belt system may further comprise a power source connected to the displacement sensor.
  • the power source may be directly or indirectly connected to the displacement sensor and/or the processor.
  • the power source may be a finite power source, e.g. a battery, or may be directly or indirectly connected to an electrical grid, e.g., “plugged in” to an electrical system that provides on demand electricity.
  • Figure 1 depicts a sensor belt (10) according to some aspects disclosed herein being worn by a subject (1), optionally representing a human patient.
  • the sensor belt (10) which is only partially visible, is fastened around the chest of the subject (1).
  • the sensor belt (10) comprises a band (12) and a first sensing device (20) (e.g., displacement sensor (20)).
  • Figure 2 depicts a portion of a sensor belt according to some aspects disclosed herein, with a band (12) and a fastening means (15) connecting a first locus (17) of the band with a second locus (18) of the band.
  • the first locus (17) and the second locus (18) may represent opposite ends of a single, continuous band segment, or they may be positioned on different segments of the band (10), i.e., a first segment and a second segment, such that the fastening means also connects such two segments of the band (12).
  • the sensor belt (10) comprises a pretensioner (16) for adjusting the longitudinal extension of the band (12) to the circumference of the chest of the subject (not shown).
  • Figure 3 depicts an example of a first sensing device (20) (e.g., displacement sensor (20)) according to some aspects of the present disclosure. Portions of the band (12) are visible which are connected to the first sensing device (20) (e.g., displacement sensor (20)) via connectors (14) of which one affixes the band (12) to the housing (22) of the sensing device (20), and the other one affixes the band (12) to a movable structure which in this case is an iron core piece (30) (which may be an example of a measurement target, e.g., measurement target (141)).
  • a movable structure which in this case is an iron core piece (30) (which may be an example of a measurement target, e.g., measurement target (141)).
  • the band portions thus connected via the sensing device (20) potentially represent a first (17) and a second locus (18), e.g., opposite ends, of a single band segment.
  • the band portions thus connected via the sensing device (20) represent two different segments of the band (12) of the sensor belt.
  • the functional sensor parts e.g., sensor (140)
  • the functional sensor parts are arranged, including an inductive sensing element (28) (which may be an example of a sensing circuit, e.g., sensing circuit (142)) which slidingly receives an iron core piece (30) which is at least partially insertable within the inductive sensing element (28).
  • the movement of the inductive sensing element (28) and the iron core piece (30) relative to one another, whose direction (38) is indicated in the figure, are caused by the expansion of the band (12) in response to the breathing maneuver of the subject (not shown).
  • the movement of the iron core piece (30) relative to the inductive sensing element (28) creates an electrical signal which may be transmitted to electronic component (32) which may, for example, include one or more amplifiers and/or transducers.
  • a leaf spring (24) e.g., with two metal leaves attached to one another such as to form a four-bar linkage is shown (which may be an example of a displacement arm (120) comprising a plurality of leaf springs (121, 122)).
  • the leaf spring (24) thus represents a part of a deformable member (e.g., displacement arm (120)) that responds to the movement of the band (12).
  • one of the two ends of the leaf spring (24) is immovable (e.g., fixed end (125)) with respect to the housing (22) (e.g., relative to base (100), which may be part of housing (22)) by means of its fixation (26) (which may be an example of a mount member (124)) and thereby also immovable with respect to a first locus (17) or segment of the band (12); whereas the other end of the leaf spring (24) is movable (e.g., free end (126)) with respect to the housing (22) (e.g., relative to base (100) which may be part of housing (22)) and connected via the iron core piece (30) (as discussed elsewhere, free end (126) of displacement arm (120) comprises displaceable input mount (130) to which band (12) may be attached, and measurement target (141) may be attached to free end (126) of displacement arm (120)) to a second locus (18) or segment of the band (12).
  • a guiding member (36) is arranged for guiding the movement of the movable connector (14) and the associated band portion at its second locus (18) or segment.
  • a gasket (34) is arranged for protecting the inside of the housing (22) from contamination.
  • FIG 4 depicts an example of a second sensing device (40) (e.g., electrical sensor (40)) according to some aspects of the present disclosure. Also shown is a segment of the sensor belt with the band (12), the fastening means (15), and the pretensioner (16) as previously depicted.
  • the second sensing device (40) in this example, comprises three electromyography (EMG) sensor patches (42), each patch comprising an electrode (44) adapted for surface EMG.
  • EMG electromyography
  • Each of the electrodes (44) is connected by wire (52) with a signal distributor (40), which is electrically connected by wire (52), for example, with an amplifier (not shown).
  • Figures 5A, 5B, and 5C depict an aspect of the first sensing device as an exemplary displacement sensor (20).
  • Figure 5A shows displacement sensor (20) from above and
  • Figures 5B and 5C show displacement sensor (20) from a side view.
  • Displacement sensor (20) comprises a base (100), which may be a part of the housing (22) or may be a separate structure.
  • Fixed input mount (110) is fixed to base (100).
  • Displacement arm (120) extends from a fixed end (125) to a free end (126). Fixed end (125) is fixed to base (100).
  • Free end (126) comprises a displaceable input mount (130) that is aligned with fixed input mount (110), e.g., aligned along displacement axis (150).
  • Displacement arm (120) has one degree of freedom along displacement axis (150) as described above.
  • Displacement axis (150) is oriented perpendicular to displacement arm (120), and free end (126) of displacement arm (120) translates substantially linearly along displacement axis (150) as described above.
  • displacement axis (150) may be considered an x- axis; with a y-axis perpendicular to and coplanar with displacement axis (15), e.g., a longitudinal axis of displacement arm 120 or parallel to the longitudinal axis of displacement arm 120; and a z-axis perpendicular to the plane formed by the x-axis and y-axis.
  • Displacement sensor (20) comprises sensor (140).
  • Sensor (140) is configured to determine displacement of the free end (126) of displacement arm (120) along displacement axis (150).
  • Sensor (140) may be configured to determine the displacement of the free end (126) of displacement arm (120) along displacement axis (150) within a target area (151) that may also correspond to a region where the free end (126) of displacement arm (120) travels substantially linearly along displacement axis (150).
  • One or more stoppers (160) may be fixed to base (100) and limit translation of the free end (126) of displacement arm (120), e.g., limit translation to target area (151).
  • Figures 5B and 5C show a side view of displacement sensor (20). Various elements are omitted for illustrative purposes.
  • Figure 5C differs from Figure 5B in that it shows that fixed end (125) of displacement arm (120) may be fixed to base (100) in any orientation and is not limited to, for example, in an arrangement where displacement arm (120) is parallel to base (100).
  • displacement arm (120) may be directly cantilevered from base (100) without the fixed end (125) orienting displacement arm (120) in a particular arrangement.
  • fixed end (125) may orient displacement arm (120) in a particular orientation as may be shown in Figure 5B.
  • Figures 6A and 6B depict an example of displacement sensor (20).
  • Figure 6A shows displacement sensor (20) from above and
  • Figure 6B shows displacement sensor (20) from a side view.
  • Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • Figures 6A and 6B show displacement arm comprising a leaf spring (121) extending from fixed end (125) to free end (126) with leaf spring (121) cantilevered at fixed end (125) with a planar shape of leaf spring (121) oriented perpendicular to displacement axis (150).
  • Displacement arm (120) may further comprise a mount member (124) that fixes and cantilevers fixed end (125) of leaf spring (121) to base (100). In this aspect of the disclosure, mount member (124) may orient displacement arm (120) in a particular arrangement.
  • Figures 7A and 7B depict an example of displacement sensor (20).
  • Figure 7A shows displacement sensor (20) from above and
  • Figure 7B shows displacement sensor (20) from a side view.
  • Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • Figures 7A and 7B show displacement arm (120) comprises mount member (124), a plurality of leaf springs (121, 122), and connecting member (123).
  • Mount member (124) is fixed to base (100).
  • the plurality of leaf springs (121, 122) extend from fixed end (125) to free end (126) and are cantilevered af fixed end (125) of displacement arm (120) from mount member (124).
  • the planar shape of each leaf spring of the plurality of leaf springs (121, 122) are oriented perpendicular to displacement axis (150) and are in parallel to one another.
  • Connecting member (123) is attached to free end (126) of the plurality of leaf springs (121, 122) for translation of free end (126) of the plurality of leaf springs (121, 122) in unison along displacement axis (150).
  • Figures 8A and 8B depict an example of displacement sensor (20).
  • Figure 8A shows displacement sensor (20) from above
  • Figure 8B shows displacement sensor (20) from a side view.
  • Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • Figures 8A and 8B show displacement sensor (20) with regard to an aspect of sensor (140) comprising measurement target (141) and sensing circuit (142).
  • Measurement target (141) is attached to free end (126) of displacement arm (120) for substantially linear co-translation of measurement target (141) along displacement axis (150).
  • Sensing circuit (142) is attached to base (100) and spaced apart from free end (126) of displacement arm (120) and measurement target (141) to form a gap (170) between sensing circuit (142) and measurement target (141), as well as the free end (126) of displacement arm (120).
  • Sensing circuit (142) is configured to determine translation of measurement target (141) along displacement axis (150).
  • Sensing circuit (142) may be arranged in target area (151) to determine translation of measurement target (141) attached to free end (126) of displacement arm (120).
  • Sensing circuit (142) may comprise one or more planar coils (143) that are arranged parallel to displacement axis (150) with the one or more planar coils (143) arranged at a fixed distance from displacement axis (150) along which measurement target (141) is configured to translate with free end (126) of displacement arm (120).
  • the one or more planar coils (143) may be coplanar.
  • the one or more planar coils (143) may comprise a plurality of planar coils (143-1, 143-2) that are arranged in parallel planes.
  • the plurality of planar coils (143-1, 143-2) are electrically isolated from one another on respective substrates (142-1, 142-2); for example, the substrate may be formed by distinct layers or may be monolithically formed as a single substrate with one or more planar coils embedded within the substrate.
  • Sensing circuit (142) may further comprise a ferromagnetic structure (148) on a side of the one or more planar coils opposite to measurement target (141).
  • Figure 10 depicts an example of aspects of sensor (140) comprising measurement target (141) and one or more planar coils (143). Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • Figure 10 depicts sensing circuit (142) comprising the one or more planar coils (143) corresponding to target area (151) and measurement target (141) aligned over target area (151) and displacement axis (150).
  • a two-dimensional outline of measurement target (141) is provided for illustrative purposes.
  • Planar coils (143) may further comprise one or more contact points (144).
  • sensing circuit (142) may comprise two or more planar coils (143) having turns arranged in a triangular shape with respective hypotenuses and sides of the triangular shapes of the two or more planar coils arranged in parallel forming an overall quadrilateral shape.
  • Figures 11A and 11B depict an example of displacement sensor (20).
  • Figure 11A shows displacement sensor (20) from above and
  • Figure 11B shows displacement sensor (20) from a side view.
  • Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • sensor (140) may be attached to a side of displacement arm (120). While Figures 11A and 11B depict sensor (140) on a particular side of displacement arm (120), the location of sensor (140) is not limited thereto and may be, for example, located on an opposing side of displacement arm (120) or an adjacent side to the depicted side in Figures 11A and 11B.
  • sensor (140) may comprise one or more strain gauges attached to displacement arm (120). As the strain gauge can determine compressive and tensile forces directly on displacement arm (120), it is not necessary to arrange components of sensor (140) within a target area with an aligned sensing circuit and measurement target. However, free end (126) of displacement arm (120) is still configured to travel along displacement axis (150) and may be limited in travel by one or more stoppers (160).
  • Figure 12 depicts an example of aspects of sensor (140) comprising one or more strain gauges (145, 146) attached to displacement arm (120) comprising a leaf spring (121). Various elements are omitted for illustrative purposes and same or similar features are not repeated here for brevity.
  • sensor (140) comprises one or more strain gauges (145, 146) attached to displacement arm (120).
  • a first strain gauge (145) may be attached to a leaf spring (121) of the plurality of leaf springs (121, 122) closer to fixed end (125) than free end (126), and a second strain gauge (146) may be attached to a leaf spring (121) of the plurality of leaf springs (121, 122) closer to free end (126) than fixed end (125).
  • First strain gauge (145) and second strain gauge (146) may be located equidistant from neutral zone (147) of leaf spring (121).
  • Figure 13 depicts an exemplary strain gauge, e.g., first strain gauge (145) and/or second strain gauge (146).
  • the strain gauge includes contact pads (181) and an active area (182) with a conductive pattern that is configured to elastically deform based on applied stresses to the strain gauge that vary resistivity of the conductive pattern.
  • FIG 14 is a diagram of an exemplary bridge circuit (300).
  • sensing circuit (142) of sensor (140) may comprise a bridge circuit (300) with two or more planar coils (e.g., 143-1, 143-2) forming a half-bridge of the bridge circuit (300).
  • the sensor (140) may comprise a bridge circuit (300) with the two or more strain gauges (e.g., 145, 146) forming a half-bridge of the bridge circuit (300).
  • Bridge circuit 300 is attached to a power source, as shown in Figure 14, the power source is exemplarily an alternating current power source.
  • bridge circuit (300) depicts contact nodes (370), representative resistances (310, 320, 330, and 340), and representative inductances (350, 360).
  • the half bridge formed by two or more planar coils or two or more strain gauges may be represented, respectively, by representative resistances and inductances (330, 350) and (340, 360).
  • a sensor belt system as depicted in Figure 15 is provided comprising sensor belt (10) comprising displacement sensor (20); processor (80) connected to displacement sensor (20) and optionally electrical sensor (40); and power source (90).
  • Processor (80) is configured to receive output from displacement sensor (20) and/or electrical sensor (40) and determine one or more breathing parameters based on the output of displacement sensor (20) and/or electrical sensor (40).

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  • Oral & Maxillofacial Surgery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un capteur de déplacement comprenant : une base comprenant un support d'entrée fixe ; un bras de déplacement comprenant : une extrémité fixe fixant le bras de déplacement à la base, et une extrémité libre, l'extrémité libre comprenant : un support d'entrée déplaçable aligné avec le support d'entrée fixe, le bras de déplacement ayant un degré de liberté le long d'un axe de déplacement perpendiculaire au bras de déplacement pour permettre une translation sensiblement linéaire de l'extrémité libre du bras de déplacement le long de l'axe de déplacement ; et un capteur configuré pour déterminer le déplacement de l'extrémité libre du bras de déplacement le long de l'axe de déplacement. Le capteur de déplacement peut faire partie d'une ceinture de capteur, par exemple, une ceinture de capteur pour surveiller l'état d'un sujet humain, par exemple, un état respiratoire. La ceinture de capteur peut faire partie d'un système de ceinture de capteur.
PCT/EP2024/071097 2023-07-25 2024-07-25 Capteur de déplacement, ceinture de capteur et système de ceinture de capteur WO2025021909A1 (fr)

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EP23187516.2 2023-07-25

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US4966155A (en) * 1985-01-31 1990-10-30 The University Of Strathclyde Apparatus for monitoring physiological parameters
US5131399A (en) * 1990-08-06 1992-07-21 Sciarra Michael J Patient monitoring apparatus and method
US20030151402A1 (en) * 2000-06-26 2003-08-14 Ulrich Kindler Device for contactless measurement of a displacement path, especially for the detection of position and movement
US20040176709A1 (en) * 1999-08-09 2004-09-09 Van Brunt Nicholas P. Mechanical chest wall oscillator
JP2006017664A (ja) * 2004-07-05 2006-01-19 Mitsutoyo Corp 変位検出器
US20150342518A1 (en) * 2014-05-07 2015-12-03 Andre Maxim Persidsky System and method to monitor, guide, and evaluate breathing, utilizing posture and diaphragm sensor signals
US20180256074A1 (en) * 2014-05-07 2018-09-13 Prana Tech Llc System and method to monitor, guide, and evaluate breathing, utilizing posture and diaphragm sensor signals
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US20220087575A1 (en) * 2014-05-07 2022-03-24 Prana Tech Llc System and method to monitor, guide, and evaluate breathing

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US4966155A (en) * 1985-01-31 1990-10-30 The University Of Strathclyde Apparatus for monitoring physiological parameters
US5131399A (en) * 1990-08-06 1992-07-21 Sciarra Michael J Patient monitoring apparatus and method
US20040176709A1 (en) * 1999-08-09 2004-09-09 Van Brunt Nicholas P. Mechanical chest wall oscillator
US20030151402A1 (en) * 2000-06-26 2003-08-14 Ulrich Kindler Device for contactless measurement of a displacement path, especially for the detection of position and movement
JP2006017664A (ja) * 2004-07-05 2006-01-19 Mitsutoyo Corp 変位検出器
US20150342518A1 (en) * 2014-05-07 2015-12-03 Andre Maxim Persidsky System and method to monitor, guide, and evaluate breathing, utilizing posture and diaphragm sensor signals
US20180256074A1 (en) * 2014-05-07 2018-09-13 Prana Tech Llc System and method to monitor, guide, and evaluate breathing, utilizing posture and diaphragm sensor signals
US20220087575A1 (en) * 2014-05-07 2022-03-24 Prana Tech Llc System and method to monitor, guide, and evaluate breathing
US20200139126A1 (en) * 2017-07-11 2020-05-07 The General Hospital Corporation Systems and methods for respiratory-gated nerve stimulation
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