WO2020121199A1 - Systèmes et procédés de compensation de mouvement dans une surveillance de respiration ultrasonore - Google Patents

Systèmes et procédés de compensation de mouvement dans une surveillance de respiration ultrasonore Download PDF

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Publication number
WO2020121199A1
WO2020121199A1 PCT/IB2019/060626 IB2019060626W WO2020121199A1 WO 2020121199 A1 WO2020121199 A1 WO 2020121199A1 IB 2019060626 W IB2019060626 W IB 2019060626W WO 2020121199 A1 WO2020121199 A1 WO 2020121199A1
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WIPO (PCT)
Prior art keywords
magnetic field
probe
unit
accelerometer
internal structure
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Application number
PCT/IB2019/060626
Other languages
English (en)
Inventor
Morten Eriksen
George Refseth
Knut Løklingholm
Nicolay Berard-Andersen
Nicolas SOUZY
Torgeir Hamsund
Original Assignee
Respinor As
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
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Priority claimed from US16/216,632 external-priority patent/US10398351B1/en
Priority claimed from US16/216,639 external-priority patent/US10595821B1/en
Application filed by Respinor As filed Critical Respinor As
Priority to AU2019395915A priority Critical patent/AU2019395915A1/en
Priority to CN201980088949.2A priority patent/CN113301845A/zh
Priority to KR1020217021700A priority patent/KR20210102376A/ko
Priority to JP2021532863A priority patent/JP7453695B2/ja
Priority to US17/311,590 priority patent/US20220045451A1/en
Priority to CA3123189A priority patent/CA3123189A1/fr
Priority to EP19824008.7A priority patent/EP3893753A1/fr
Publication of WO2020121199A1 publication Critical patent/WO2020121199A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5269—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving detection or reduction of artifacts
    • A61B8/5276—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving detection or reduction of artifacts due to motion
    • 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
    • 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
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • A61B5/721—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4236—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4245—Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
    • A61B8/4254—Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient using sensors mounted on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • 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
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • 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
    • 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
    • A61B5/6832—Means for maintaining contact with the body using adhesives

Definitions

  • the present disclosure relates to methods, devices and systems for motion compensation in ultrasonic respiration monitoring of patients, including correcting for measurement errors resulting from movements of the abdominal region during respiration.
  • Measurement and monitoring of respiration is important for treatment of a wide range of medical conditions in patients.
  • the thoracic diaphragm is the main breathing muscle, and its dysfunction can be symptomatic of many respiratory disorders and conditions.
  • an ultrasonic transducer device may be located in a housing of a probe and embedded therein by an ultrasound sonolucent material, such as a silicone rubber material or another material that allows passage of ultrasonic waves.
  • the ultrasonic transducer probe may be placed on the skin surface of a patient’s body using a double-sided tacky tape having a reinforcing web between its two tacky layers.
  • the present disclosure relates to systems and methods for correcting measurement errors during ultrasonic respiration monitoring, in which the measurement errors result from abdominal movements in a patient’s body during breathing.
  • Embodiments of the invention detect motion of various tissues and structures in the body including, for example, the spleen, liver, or a kidney. But, for purposes of illustrating the principles of embodiment of the invention, the following discussions primarily focus on motion detection of the liver. For example, when comparing measurements made with an abdominal probe attached to the front side of the human body and moving with the abdominal wall, liver excursion appears to be about 30 to 40% less than when measuring with a mechanically fixed probe.
  • a respiration detection system includes a first probe and a second probe.
  • the first probe is configured to be placed on a front side of the body of a patient, and the second probe is configured to be placed on a dorsal side of the body.
  • the first probe includes an ultrasonic transducer, a first accelerometer unit, and a first magnetic field unit, in which the ultrasonic transducer, the first accelerometer unit, and the first magnetic field unit are stationary located in the first probe.
  • the ultrasonic transducer is stationary located within the first probe and has a transceiving face oriented at an acute angle relative to a front plane of the first probe.
  • the ultrasonic transducer is configured to produce an ultrasound beam at the transceiving face for transmission into an internal structure inside the body of the patient.
  • the second probe includes a second accelerometer unit and a second magnetic field unit, in which the second accelerometer unit and the second magnetic field unit are stationary located in the second probe.
  • the ultrasonic transducer, the first and second accelerometer units, and the first and second magnetic field units are coupled to a signal processor.
  • a combination of the first and second accelerometer units and the first and second magnetic units are configured to produce correction output signals that are a function of spatial positional movement and orientation of the ultrasonic transducer upon respiration of the patient. The signals thus obtained are used for correcting the ultrasound measurement of distance between the first sensor and the moving tissue inside the human body in order to provide more accurate output signals.
  • the respiration detection system comprises a first probe comprising: an ultrasonic transducer stationary located within the first probe and having a transceiving face oriented at an acute angle relative to a front plane of the first probe, wherein the ultrasonic transducer is configured to produce an ultrasound beam at the transceiving face for transmission into an internal structure inside a body of a patient, a first accelerometer unit, and a first magnetic field unit, wherein the ultrasonic transducer, the first accelerometer unit, and the first magnetic field unit are stationary located in the first probe; and a second probe comprising: a second accelerometer unit, and a second magnetic field unit, wherein the second accelerometer unit and the second magnetic field unit are stationary located in the second probe; wherein the ultrasonic transducer, the first and second accelerometer units, and the first and second magnetic field units are coupled to a signal processor, wherein the first probe is configured to be placed on a front side of the body of the patient, where
  • a method for motion compensation in ultrasound-based detection of respiration parameters of a patient includes attaching a first probe to a front body surface of the patient, the first probe having an ultrasound transducer, a first accelerometer unit, and a first magnetic field unit, attaching a second probe to a dorsal body surface of the patient, the second probe having a second accelerometer unit, and a second magnetic field unit, and providing a signal processor coupled to the ultrasonic transducer, the first and second accelerometer units, and the first and second magnetic field units.
  • the method further includes transmitting, from the ultrasound transducer in the first probe, an ultrasound beam into an internal structure inside the body of the patient, receiving, at the ultrasonic transducer in the first probe, ultrasound echo signals from the internal structure, generating, by the second magnetic field unit, a magnetic field transmitted to and detected by the first magnetic field unit, and calculating, using the signal processor, an orientation of the first accelerometer unit relative to a fixed coordinate frame using derived parameters from the first accelerometer unit, and further calculating the derived parameters as unit vectors representing an orientation of the ultrasound beam and an orientation of the first magnetic field unit.
  • the method includes calculating, using the signal processor, an orientation of the second accelerometer unit relative to a fixed coordinate frame using further derived parameters, and calculating the further derived parameters including body back support tilt angle (a) and unit vectors representative of a spatial direction from the second magnetic field unit to the first magnetic field unit, an orientation of the second magnetic field unit, and an expected direction of motion of the internal structure during exhalation, calculating, using the signal processor, any varying distance between the first and second magnetic field units based on the detection of the magnetic field, and processing, using the signal processor, results from the calculated orientations, derived parameters from the first and second accelerometer units, and the varying distance to generate correction parameters to compensate for measurement errors in received ultrasound echo signals caused by motion of the ultrasound transducer.
  • body back support tilt angle a
  • unit vectors representative of a spatial direction from the second magnetic field unit to the first magnetic field unit
  • an orientation of the second magnetic field unit an expected direction of motion of the internal structure during exhalation
  • FIGS. 1A-1C illustrate example diagrams of a human torso showing ultrasonic transducer device placement, according to embodiments of the present disclosure.
  • FIGS. 2A and 2B illustrate example diagrams of probe locations on the human body for motion detection of the liver, spleen, or kidney, according to embodiments of the present disclosure.
  • FIG. 3 illustrates a rear perspective view of a front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 4 illustrates a rear plan view of the probe of FIG. 3, according to embodiments of the present disclosure.
  • FIG. 5 illustrates a cross-section of a first embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 6 illustrates a cross-section of a second embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 7 illustrates a cross-section of a third embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 8 illustrates a cross-section of a fourth embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 9 illustrates a cross-section of a fifth embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 10 illustrates a cross-section of a sixth embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 11 illustrates a cross-section of a seventh embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 12 illustrates a cross-section of an eight embodiment of the front ultrasonic transducer device probe, according to embodiments of the present disclosure.
  • FIG. 13 illustrates a perspective, front full view of the probe of FIGS. 9 and 10, prior to installation of first and second materials in the probe, according to embodiments of the present disclosure.
  • FIG. 14 illustrates another perspective, front full view of the probe of FIG. 13 from a different angle, according to embodiments of the present disclosure.
  • FIG. 15 illustrates a perspective, front sectioned view of the probe of FIGS. 13 and 14, according to embodiments of the present disclosure.
  • FIG. 16 illustrates a perspective rear view of a rear probe to be placed on the dorsal side of the human body and interface with the front probe on the front side of the human body, according to embodiments of the present disclosure.
  • FIG. 17 illustrates a perspective, front full view of the probe of FIG. 16, prior to installation of a fourth material and optional application of a tacky body, according to embodiments of the present disclosure.
  • FIG. 18 illustrates a perspective, front sectioned view of the probe of FIG. 17, according to embodiments of the present disclosure.
  • FIG. 19 illustrates a cross-section of the rear probe before installation of the fourth material, according to embodiments of the present disclosure.
  • FIG. 20 illustrates a sectional view of FIG. 19 after installation of the fourth material, according to embodiments of the present disclosure.
  • FIG. 21 illustrates a sectional view of FIG. 20 after addition of a tacky body of a fifth material, an adhesive member, or a double-sided tacky tape material, according to embodiments of the present disclosure.
  • FIG. 22 illustrates a simplified block schematic diagram of an embodiment of the inventive system for performing signal processing related to range calculation and motion compensation, according to embodiments of the present disclosure.
  • FIG. 23 illustrates a cross-section diagram showing basic principles for respiration detection using ultrasound beam directed at a human liver, according to embodiments of the present disclosure.
  • FIG. 24 illustrates a cross-section diagram showing motion of a chest and abdominal region of the human body during respiration, according to embodiments of the present disclosure.
  • FIG. 25 illustrates a cross-section diagram showing effects of abdominal shape changes during respiration, according to embodiments of the present disclosure.
  • FIG. 26 illustrates a cross-section diagram showing rear (ancillary) sensor probe placement, as also shown in FIGS. 1 A, IB or 2, according to embodiments of the present disclosure.
  • FIG. 27 illustrates a schematic diagram showing derivation of signals from accelerometers in the front and rear probes, according to embodiments of the present disclosure.
  • FIG. 28 illustrates a schematic diagram showing signal processing related to range calculation and motion compensation, according to embodiments of the present disclosure.
  • FIG. 29 illustrates an example graph showing first rotation (p) seen from the positive x-axis, according to embodiments of the present disclosure.
  • FIG. 30 illustrates an example graph showing orientation of the gravity vector prior to a second rotation as seen from the positive y-axis, according to embodiments of the present disclosure.
  • FIG. 31 illustrates an example graph showing probe coordinates and measured acceleration seen from the positive y-axis, according to embodiments of the present disclosure.
  • FIG. 32 illustrates an example graph showing a situation after the first rotation seen from the global positive x-axis, according to embodiments of the present disclosure.
  • FIG. 33 illustrates direction of the measured acceleration vector after the second rotation, according to embodiments of the present disclosure.
  • FIG. 34 illustrates a calibration setup, according to embodiments of the present disclosure.
  • Embodiments may be implemented in hardware (e.g., circuits), firmware, software, or any combination thereof. Embodiments may also be implemented as instructions stored on a machine-readable medium, which may be read and executed by one or more processors.
  • a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computing device).
  • a machine-readable medium may include read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.), and others.
  • firmware, software, routines, instructions may be described herein as performing certain actions. However, it should be appreciated that such descriptions are merely for convenience and that such actions in fact result from computing devices, processors, controllers, or other devices executing the firmware, software, routines, instructions, etc. Further, any of the implementation variations may be carried out by a general purpose computer, as described below.
  • each module or unit shall be understood to include at least one of software, firmware, or hardware (such as one or more of a circuit, microchip, and device, or any combination thereof), and any combination thereof.
  • each module or unit may include one, or more than one, component within an actual device, and each component that forms a part of the described module may function either cooperatively or independently of any other component forming a part of the module.
  • multiple modules or units described herein may represent a single component within an actual device. Further, components within a module or unit may be in a single device or distributed among multiple devices in a wired or wireless manner.
  • FIGS. 1A-1C illustrate example diagrams of a human torso showing ultrasonic transducer device placement, according to embodiments of the present disclosure.
  • FIG. 1A shows a right side view of a torso 101 of a human onto which both an ultrasonic transducer device front probe 102 and a different rear probe 104 are attached to a front side 103 and dorsal side 105 of the human, respectively.
  • FIG. IB shows a tentative location of the rear probe 104
  • FIG. 1C shows a tentative location of the front probe 102.
  • the front and rear probes may be referred to as first and second probes, respectively.
  • the probes 102, 104 are seen located close to the right mid-clavicular line 106, it will be appreciated that that these probes may be located laterally of the line 106 and/or at a different position along the direction of the line 106 than the positions shown in FIGS. IB and 1C.
  • the right mid-clavicular line is denoted as 106
  • the left mid-clavicular line is denoted as 108.
  • the probes are preferably located adjacent the line 108.
  • the probes are preferably located adjacent either line 106 or line 108, dependent on the selected one of the kidneys in the body.
  • measurement of motion of internal tissue region or internal structures is not limited to the liver. Any parenchymatous soft tissue that can be accessed by ultrasound from the body surface may be used. In addition to the liver, the spleen and the kidneys may be of particular interest for recording of diaphragm motion, according to some embodiments.
  • FIGS. 2 A and 2B illustrate example diagrams of probe locations on the human body for motion detection of the liver, spleen, or kidney, according to embodiments of the present disclosure.
  • FIG. 2A illustrates probe locations on the human body 101, in which the probes 102, 104 are suitably linked or coupled to a processor (e.g., signal processor 134 shown in FIG. 22) and display 109.
  • FIG. 2B illustrates front probe 102 locations for motion detection of the liver, spleen, or kidney in a patient’s body.
  • FIG. 3 illustrates a rear perspective view of a front ultrasonic transducer device probe 102, according to embodiments of the present disclosure.
  • FIG. 4 illustrates a rear plan view of the probe 102 of FIG. 3, according to embodiments of the present disclosure.
  • the ultrasonic transducer device front probe 102 is further described with reference to FIGS. 5, 6, 9, and 10.
  • the illustrated probe 102 is configured to be placed on a front body surface 103 of a human in order to direct an ultrasonic beam towards an internal structure and receive ultrasonic echo signals from the internal structure.
  • the internal structure is at least one of the liver, the spleen, or a kidney of the human.
  • a tissue region may be referred to as an internal structure inside a patient’s body.
  • the probe illustrated in FIGS. 5, 6, 9 and 10 has a housing 110, suitably made from a hard shell plastic material in a non-limiting example, with a cavity 111 in which an ultrasonic transducer 112 is located.
  • a transceiving face 113 of the transducer 112 is oriented at an acute angle W relative to a front plane 114 of the housing at or adjacent a cavity mouth of the cavity of the housing.
  • the acute angle is suitably in a range of 0 to 60 degrees.
  • the transducer 112 is fixedly located in the cavity 111 of the housing 110 by means of at least a body 115 of first material comprising an ultrasound non-sonolucent material which extends towards the front plane 114. It will be observable that the body 115 of the first material surrounds a recess 116 extending from the transceiving face 113 towards the front plane 114.
  • a first part of a body 117 of a second material comprising an ultrasound sonolucent material is located in the recess 116 at and in front of the transceiving face 113 of the transducer towards the front plane 114.
  • a second part of the body 117 of the second material is in addition applied onto a front surface 115’ of the body of the first material and made integrally engaged therewith.
  • the first and second parts of the body 117 are integral.
  • FIGS. 7, 8, 11 and 12 illustrate additional embodiments of the front ultrasonic transducer device probe.
  • the housing is simply constituted or formed by a body 118 of a first material, suitably of the same type of material as that of the body 115.
  • the transducer 112 is supported in a different way than that in the embodiments of FIGS. 5-8.
  • the transducer 112 is supported by a printed circuit board 119 and the body 115.
  • the recess is lined with an open-ended socket-like member 120 of ultrasound non-sonolucent material, and the transducer 112 is mounted at a bottom region of the open-ended socket-like member 120.
  • the material of the member 120 exhibits an acoustic dampening property, and an outer wall of the member 120 is configured to engage the body 115, 118 of the first material.
  • transducer 112 and the open-ended socket-like member 120 extend from a printed circuit board 119.
  • the member 120 with the transducer 112 located therein, as well as the printed circuit board, are supported by and embedded in the body 115, 118 of the first material.
  • the probe 102 also contains an accelerometer unit 121 (shown schematically) and a magnetic field detection unit 122 which are embedded (e.g., encapsulated) in the body 115, 118 of the first material.
  • the accelerometer unit 121, the magnetic field detection unit 122, and the transducer 112 are connected or coupled to the printed circuit board 119 and to a signal processor 134 (as shown in FIG. 22).
  • the signal processor is further described below with respect to Fig. 22.
  • the housing 110 having the cavity 111 and the body 115 of first material are suitably composed of materials having compatible properties, in particular to bond well together, but suitably also to have e.g. similar thermal expansion properties.
  • materials for the housing 110 may include a suitable plastics material or polymer(s) and/or body 115 of the first material may include an ultrasound non-sonolucent silicone rubber material or the like.
  • an ultrasound non-sonolucent silicone rubber material or the like.
  • a variety of possible additives are available (e.g., calcium carbonate, titanium dioxide, zinc oxide, quartz, glass, or other additives).
  • An example of silicone rubber with an additive is ELASTOSIL® RT 602 A/B.
  • the socket like member 120 is formed of plastics material, such additives may be used.
  • the acoustic dampening property of such additives in silicone rubber or plastics material may be dependent on particle size and particle mass density (e.g., preferably particle density being highly different from the density of silicone rubber of plastic, both being about 1,000 kg/m 3 ).
  • the body 118 of first material forming the probe housing has a rear surface region, (e.g., the surface region which does not face the skin of the human body), such as that visible in FIGS. 3 and 4.
  • the first material being present thereat preferably has a non-sticky surface property.
  • the body 118 of a first material creates the recess 116, and in FIGS. 11 and 12, the body 118 surrounds the socket member 120 in which the transducer is located.
  • the front surface 115’, 118’ of the body 115, 118 of the first material has the body 117 of the second material attached thereto.
  • the front surface 117’ of the body of the second material may exhibit one of: an inherent tacky property, an attachment face for an adhesive member or a double-sided tacky tape, and an engagement face for a tacky layer of a body of a third material.
  • the probe may be provided with a removable protective cover 123, the cover being removable prior to application of the probe onto the skin of the body 101.
  • the probe is of a self-adhesive type suitably for single-use, although double sided tacky tape may be attached to the face 117’ after a first use of the probe, provided that the face 117’ is not contaminated in such a way that the tape will not adhere.
  • an adhesive member or the double sided tacky tape is attached to the front face 117’ of the body 117 of the second material.
  • the adhesive member or double-sided tacky tape may be ultrasound sonolucent at least at a region faced by the transducer transceiving face 113.
  • the general element 124 covering the front face 117’ of the body 117 of the second material is the tacky layer of a body of a third material being ultrasound sonolucent.
  • the first and second materials are provided in the probe 102 as an integral structure, and both materials exhibit similar or compatible thermal and mechanical properties. Further, the second material and the third material are at least one of: identical, property compatible, and engagement compatible.
  • the body material type of at least one of the first, second and third materials comprises a silicone rubber material. If the first and second materials are similar, the ultrasound non- sonolucent first material may have an added component thereto to effectively obtain its desired properties. For example, an additive, such as calcium carbonate, titanium dioxide, zinc oxide, quartz, glass, or the like, may be added to a silicone rubber material to make the silicone rubber material non- sonolucent.
  • the first material is silicone rubber with one or more additives, whereas the second and third materials are silicone rubber.
  • an ultrasound non- sonolucent silicone rubber material is ELASTOSIL® RT 602 A/B
  • an ultrasound sonolucent material is ELASTOSIL® RT 601 A/B.
  • FIG. 13 illustrates a perspective, front full view of the probe of FIGS. 9 and 10, prior to installation of first and second materials encapsulated in the probe, according to embodiments of the present disclosure.
  • FIG. 13 shows the probe 102 prior to installation of an embedding (e.g., encapsulating) body 115 of a first material and application of a body 117 of a second material to fill the recess 116 down to the transducer transceiving face 113 and further to cover a front face 115’ to the body 115 of the first material.
  • an embedding e.g., encapsulating
  • FIG. 14 illustrates another perspective, front full view of the probe 102 as shown in FIG. 13, from a different angle
  • FIG. 15 illustrates a perspective, front sectioned view of the probe 102 as shown in FIGS. 13 and 14, according to embodiments of the present disclosure.
  • Wiring from a cable 125 onto the printed circuit board 119 has not been shown for sake of clarity.
  • cable 125 provides electrical connections between circuit board 119, processor, and display 109 (see FIG. 2A).
  • the first, front probe 102 is configured to cooperate or interface with a second, rear probe 104.
  • These probes are included in a respiration detection system configured to be located on a body surface of a human.
  • the ultrasonic transducer 112 is stationary located as described in reference to FIGS. 5-12 to produce an ultrasound beam directed outward from front surface plane 114 and towards an internal structure or a tissue region inside the body. Further, the probe 102 incorporates the first accelerometer unit 121 and the first magnetic field unit 122.
  • the second, rear probe 104 is shown in further detail in FIGS. 16-21.
  • 104 has a housing 126 in the form of a shell member of a plastics material and with an associated cavity 127 in which a second accelerometer unit 128 and a second magnetic field unit 129 are stationary located and suitably connected to a common printed circuit board 130. Wires from a cable 131 connecting to the printed circuit board are not shown for sake of clarity. In some embodiments, cable 131 provides electrical connections between circuit board 130, processor, and display 109 (see FIG. 2A).
  • the transducer 112, the first and second accelerometer units 121, 128, and the first and second magnetic field units 122, 129 are linked to the signal processor 134, as will be further described with reference to FIG. 22.
  • the second accelerometer unit 128 provides for measurement of tilt angles of a surface supporting the dorsal side of the human body.
  • the magnetic field sensor device of the first magnetic field unit 122 is a magnetic pickup coil in the illustrated embodiment.
  • the first and second accelerometer units 121, 128 exhibit at least two accelerometers each.
  • the first accelerometer unit 121 includes a three-axis accelerometer device.
  • Output signals provided to the signal processor 134 from the first and second accelerometer units 121, 128 and by use of the first and second magnetic field units 122, 129 are a function of spatial positional movements and orientation of the first probe 102 attached to the front side of the patient during respiration.
  • the spatial positional movement and orientation is related to at least one of heave, roll, pitch and yaw type movements resulting from breathing by the patient.
  • the second accelerometer unit 128 and the second magnetic field unit 129 are stationary located in the cavity 127 of second housing 126 by means of a body 132 of a fourth material.
  • a front face plane 132’ of the body 132 of the fourth material provides one of: a tacky property, an attachment face for an adhesive member or a double-sided tacky tape, and an engagement face for a tacky layer of a body of a fifth material.
  • a tacky property an attachment face for an adhesive member or a double-sided tacky tape
  • an engagement face for a tacky layer of a body of a fifth material is generally denoted by reference numeral 133.
  • At least one of the first, second, third, fourth, and fifth materials is suitably of a silicone rubber type.
  • at least a surface area of the second probe to abut or contact a dorsal skin area of the human body exhibits a biocompatible material, the abutting surface area of the second probe (e.g., the area of the probe surface in contact with skin) suitably being in the range of 5 - 100 cm 2 .
  • the first material is silicone rubber with an additive included to make the silicone rubber ultrasound non-sonolucent
  • the second and third materials are ultrasound sonolucent silicone rubber.
  • the fourth and fifth materials are silicone rubber.
  • the fourth and fifth materials might not need to take into consideration ultrasound aspects, because an ultrasound transducer might not be present in the dorsally located second probe 104.
  • the first, second, third, fourth, and fifth materials are commercially available.
  • the signal processor 134 controls intensity, frequency and duration of magnetic field to be generated by the second magnetic field unit.
  • the signal processor is configured to calculate, based on inputs from the first and second accelerometer units 121 and 128 and from the first magnetic field unit 122 interacting with the second magnetic field unit 129, movement and orientation of the abdominal wall of the patient’s body in relation to direction of expected motion of the internal structure in question. The movement and orientation being related to respiration parameters associated with the abdominal muscles of the patient.
  • the internal structure or tissue region of the patient is at least one of the liver, spleen, or kidney of the patient. It will be readily appreciated that detected motion of the internal structure is a function of thoracic diaphragm movement in the patient’s body.
  • the processor 134 has associated therewith a data storage
  • the processor 134 also includes therein a transceiver section 134’ operating with the transducer 112. In some embodiments, the processor 134 may cause a respiration alert unit 137 to generate one or more visual and/or audible alerts if one or more respiration parameters of the patient moves away from acceptable parameter ranges.
  • the front probe 102 has a first probe identity serial number device 138
  • the rear probe 104 has a second probe identity serial number device 139.
  • a registration and operation comparator unit 140 is provided and linked or coupled to the processor 134.
  • a patient’s identity serial number e.g., a social security, a tax personal code, or another identifier
  • a keyboard 141 which is linked to the processor 134, prior to and/or during use of the respiration detection system on a patient.
  • the unit 140 may therefore include an operation mode controller that prevents such second-hand use. In other cases, second-hand use may be acceptable if the probes 102, 104 are re-used on the original patient, and not on a new patient.
  • the operation mode controller may electronically limit numbers of re-use of a probe to a predefined number of uses, e.g., 3 to 10 uses, whereafter the processor 134 and the unit 140 may effectively block the serial numbers from the devices 138, 139.
  • the probes 102, 104 may have a respective self-tacky front face 117’, 132’, as typically could be used by an ICU (Intensive Care Unit) for single use. For these single-use probes, the probe identities may be blocked once the system is shut down, and the probes are removed from the patient.
  • a power supply 142 may deliver power to the processor 134, the data storage 135, the display 136, and the units 137, 140. In additional embodiments, required power to the probes 102, 104 are delivered via the processor 134.
  • FIGS. 23-26 An example method for motion compensation of measurement errors during respiration monitoring is described herein with reference to FIGS. 23-26.
  • FIG. 27 schematically illustrates derivation of signals from accelerometers in the front and rear probes
  • FIG. 28 schematically illustrates signal processing related to range calculation and motion compensation, according to embodiments of the present disclosure.
  • the example method is used in ultrasound-based detection of respiration parameters of a patient.
  • the detection uses an ultrasound beam 143 directed from and to an ultrasound transducer device 112 in a front probe 102 (located on a front side of the human body).
  • the ultrasound beam 143 is directed from a front body surface of the human to an internal structure or a tissue region inside the body and is reflected back to the probe 102 as ultrasound echo signals.
  • the method comprises:
  • body back support tilt angle a
  • unit vectors representative of a spatial direction from the second magnetic field unit 129 e.g., an electromagnet
  • the first magnetic field unit 122 e.g., a sensor device located in the front probe 102
  • an orientation of the second magnetic field unit 129 e.g., an expected direction of motion of the internal structure or tissue region (e.g.,
  • processing step (j) may comprise:
  • step (n) correcting the added motion values of step (m) for an instantaneous cosine value of an angle between the ultrasound beam 143 and direction of motion of the internal structure
  • the probe on the abdominal surface of a patient is moving up and down when the patient is breathing.
  • This motion has a vector component along the ultrasound beam direction 143, and the motion of the probe gives a variable under-estimation of the true motion of the liver 144, as illustrated in FIGS. 23 and 24.
  • the probe will at the same time move away from the liver, and vice versa during exhalation. This occurrence was confirmed experimentally using a mechanically fixed probe that was not allowed to move, resulting in about 40% higher estimates of liver motion compared to a freely moving probe.
  • FIGS. 23 and 24 illustrate cross-section diagrams showing basic principles for respiration detection using ultrasound beam directed at a human liver and motion of a chest and abdominal region of the human body during respiration, according to embodiments of the present disclosure.
  • the cross-section diagrams of FIGS. 23 and 24 show the motion 145 of the liver 144 and the motion 146 of the probe, and how the motion of the probe can be considered as having two components.
  • One component 147 is along the ultrasound beam direction 143. This component will directly affect and disturb the estimated motion of the liver 144.
  • the abdominal surface is conical, and not cylindrical. This abdominal shape will cause a variable tilt of the transducer 112 and the probe 102, and will thus affect the direction of the ultrasound beam 143.
  • the front probe 102 is placed in order to have acoustic access to the liver 144, there may be a substantial concavity of the surface in slim human subjects.
  • the surface is convex, as illustrated in FIG. 25. Thus, assumption of a fixed 45° angulation between the sound beam 143 and the direction 145 of the liver motion might not be valid.
  • FIG. 26 illustrates a cross-section diagram showing the basic principle of distance measurement 148 through use of placement of a dorsal (ancillary) or rear sensor probe 104.
  • the human body is supine on a bed mattress (e.g., lying face upward).
  • the probe 102 is equipped with a 3-axis accelerometer module that uses the direction of the gravity vector to estimate tilt, allowing calculation of the actual spatial direction of the ultrasound beam relative to the motion of the liver.
  • the extra, second (ancillary) sensor rear probe 104 is added at a location on the patient’s dorsal side, vertically below the front probe 102 if the patient body is supine. If the patient is in an upright posture, the front and rear probes 102, 104 may be aligned, roughly at right angles to the spine direction of the human.
  • the rear, second sensor probe 104 contains the additional accelerometer unit 128 for measuring the tilt angle of a bed upon which the patient rests, since most ICU patients have an elevated bed.
  • the tilt angle measurement may be utilized in order to have an estimate of the actual liver motion direction.
  • the rear sensor probe 104 also contains an electromagnet in the unit 129 that generates a weak alternating magnetic field that is sensed by a magnet pick-up coil in unit 122 of the front probe 102.
  • the use of the electromagnet and magnet pick-up coil allows for a continuous measurement of the up and down motion of the front probe 102 based on known relations between magnetic field strength and distance. By obtaining these calculations, the motion of the probe 102 can then be included in the estimate of liver motion.
  • Magnetic field The electromagnet on the patient’s back generates a weak magnetic field, suitably at a frequency of 33 kHz, that decays with the inverse cube of the distance.
  • the field strength is below 27 mT at distances of more than 15 mm from the cylindrical magnet centerline.
  • 27 mT is the recommended maximum magnetic field strength for continuous whole-body exposure to the public at frequencies between 3 kHz and 10 MHz. This means that a few milliliters of skin and subcutaneous tissues close to the back sensor will be exposed to field strengths above 27 mT, but always below 100 mT which is the corresponding limit for continuous occupational whole-body exposure.
  • New acceleration and magnetic sensor devices in the front probe 102 and the acceleration sensor device 128 in the rear probe are passive devices without any energy emissions. They therefore do not have any potential for harming the patient.
  • the rear sensor probe 104 might have a potential for creating pressure sores. This has been considered during the design of the sensor.
  • the probe 104 is suitably encapsulated in a biocompatible soft silicone rubber, and has, e.g., a circular 5 cm diameter flat contact surface for contact with a patient’s skin or a surface in the range of 5 to 100 cm 2 , without sharp edges and with a tapered shape towards its circumference.
  • a suitable attachment location is the back flank of a patient which is a soft tissue region between the rib cage and the pelvis, contributing to an even mechanical pressure distribution.
  • the attachment to the skin is by using one of the several attachment options used for the front probe, such as a double-sided silicone rubber tape. If the body of the fourth material or the fifth material is tacky, the rear probe may be attached to the dorsal side of the human body via one of these tacky materials.
  • the skin in and around the sensor attachment area may be carefully inspected during daily re-attachments of the rear probe, and also during routine nursing visits to the patient.
  • the occurrence of skin irritation may be recorded as an adverse event, and the patient in such a situation may be excluded from further participation.
  • Both probes 102, 104 are fully and hermetically encapsulated, suitably in electrically insulating material, such as silicone rubber with an electrical insulation of 20 kV/mm.
  • electrically insulating material such as silicone rubber with an electrical insulation of 20 kV/mm.
  • the shortest distance from an electrical conductor inside the probe to the surface is at least 1 mm. At least the bodies of the first and the fourth materials exhibit such electrical insulation properties.
  • the device is suitably powered from a medical grade external power supply delivering 12 VDC.
  • the highest voltage found inside the device is preferably not more than 18 to 24 VDC.
  • Calculation of the rear sensor probe orientation (e.g., the probe 104 located on the dorsal side of the patient) may be expressed as a rotation matrix relative to the global coordinate frame, and calculation of derived parameters:
  • the distance is calculated from the magnetic pick-up signal, the direction from the electromagnet 129 to the pick-up 122, and the orientations of the electromagnet 129 and the pick-up signal 122. This calculation also utilizes a single calibration value (k) determined during production of the system.
  • the distance 148 between the rear probe and the front probe is decomposed along the sound beam direction 143 and differentiated to give incremental motion. This is added to the incremental motion detected by the Doppler system in the same time interval. The summed motion is then corrected for the instantaneous cosine of the angle between the sound beam and the liver motion direction. Displacement is then calculated by integration.
  • Accelerometer readings are: a Ax , a Ay , and a Az (signed, arbitrary units)
  • the orientation of the probe 104 may be described by a sequence of two rotations:
  • FIG. 29 illustrates an example graph showing a first rotation (p) seen from the positive x- axis, which can be calculated as follows:
  • FIG. 30 shows an example of orientation of the gravity vector prior to the second rotation as seen from the positive y-axis.
  • the second rotation is calculated as follows: [0141] Note that sin(a) and cos(a) are normally utilized for calculation of front probe 102 orientation. The angle a itself might not need to be evaluated.
  • the unit vector orientation of the electromagnet in the second magnetic field unit 129 of the rear probe 104 is:
  • the unit vector direction of liver motion expressed in the global coordinate system is:
  • the unit vector from the rear electromagnet 129 to the front sensor pickup 122 is:
  • Accelerometer readings are: a Px , a Py , and a Pz
  • Bed tilt angle is: a (from back sensor, expressed as sin(a) and cos(a)).
  • a sequence of rotations that positions the probe 102 in a manner that makes the measured acceleration vertical and upwards, and assures that the probe 102 x-axis and the body centerline are in the same plane are:
  • the calculations are derived by finding the sequence of rotations of a stiff body consisting of the probe 102 and its associated measured gravity vector that aligns the measured gravity vector with the global negative z-axis (upwards).
  • FIG. 31 illustrates probe coordinates and measured acceleration seen from the positive y-axis.
  • user errors in probe 102 placement might cause this condition. If this happens, an error message may be given, and the session may be re-started.
  • the rotation angle f has the following properties:
  • FIG. 32 shows the situation after rotation (1) seen from the global positive x-axis.
  • the next rotation (2) around the global x-axis may bring the acceleration vector into the global x-z plane.
  • the equations include:
  • FIG. 33 shows the direction of the measured acceleration vector after rotation (2).
  • RP3 may be the same as RA2, from Eqn. (7) and might not need to be recalculated.
  • the ultrasound beam direction (45° downwards) is:
  • these trigonometric functions are preferably pre-calculated.
  • the orientation of the magnet pickup 122 (angled, in one embodiment, at 26° rotation around the probe x-axis) is:
  • these trigonometric functions are also preferably pre calculated.
  • Ncai The signal reading during calibration. It is assumed that the emitting magnets in the second magnetic field unit 129 and the receiving magnets in the first magnetic field unit 122 are oriented parallel with each other on a flat surface and orthogonal to the distance between their centerlines when the system is calibrated;
  • Nmeas The signal reading during measurements
  • vmm Unit vector from magnet 129 to pickup 122;
  • Vmagnet Unit vector giving the orientation of the electromagnet 129.
  • Vpickup Unit vector giving the orientation of the magnet pickup 122 in the front probe 102.
  • S is the distance from the dipole along the direction given by vTM, and
  • a circumflex ( L ) indicates a unit vector.
  • the received signal (Nmeas) from the pickup coil 122 will be the component of the field that is parallel with the pickup 122 according to the following equation:
  • k is a constant that combines
  • the constant k is determined by a calibration procedure.
  • Equation 28 K is determined during calibration. Assuming that the ferrite rods are located at a distance of Seal from each other, and oriented as indicated by FIG. 34, then solving Equation 28 provides:
  • the constant k is determined during production of each system of probes according to Equation 31 and is stored in non-volatile memory.
  • a practical value for Seal is 0.25 m.
  • the motion compensation method described herein compensates for continuous variations in beam orientation, bed angle, and abdominal surface motion. It assumes that the abdominal surface moves in a direction (vmm) perpendicular to the mattress.
  • an error message or warning may be issued since measurements then will be very angle-dependent and inaccurate.
  • the present disclosure thereby offers the possibility to compute contribution of up and down motion to the ultrasound Doppler signal provided, and thereby compensate for the related signal errors.

Abstract

L'invention concerne, par exemple, des procédés, des dispositifs et des systèmes de compensation de mouvement dans une surveillance de respiration ultrasonore. Un système de détection de respiration comprend une première sonde placée sur un côté avant du corps d'un patient et une seconde sonde placée sur un côté dorsal du corps. La première sonde comprend un transducteur à ultrasons, une première unité d'accéléromètre et une unité de capteur de champ magnétique, et la seconde sonde comprend une seconde unité d'accéléromètre et une unité de capteur de champ magnétique. Du fait de la respiration du patient, la région abdominale du corps bouge, créant des erreurs de mesure lorsqu'un faisceau ultrasonore est dirigé vers une structure interne (région de tissu interne) à l'intérieur du corps du patient. Une correction pour de telles erreurs de mesure utilise des données d'entrée provenant des première et seconde unités d'accéléromètre et de l'unité de capteur de champ magnétique.
PCT/IB2019/060626 2018-12-11 2019-12-10 Systèmes et procédés de compensation de mouvement dans une surveillance de respiration ultrasonore WO2020121199A1 (fr)

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AU2019395915A AU2019395915A1 (en) 2018-12-11 2019-12-10 Systems and methods for motion compensation in ultrasonic respiration monitoring
CN201980088949.2A CN113301845A (zh) 2018-12-11 2019-12-10 用于超声呼吸监测中的运动补偿的系统和方法
KR1020217021700A KR20210102376A (ko) 2018-12-11 2019-12-10 초음파 호흡 모니터링에서의 모션 보상을 위한 시스템들 및 방법들
JP2021532863A JP7453695B2 (ja) 2018-12-11 2019-12-10 超音波呼吸監視における運動補償のためのシステムおよび方法
US17/311,590 US20220045451A1 (en) 2018-12-11 2019-12-10 Systems and methods for motion compensation in ultrasonic respiration monitoring
CA3123189A CA3123189A1 (fr) 2018-12-11 2019-12-10 Systemes et procedes de compensation de mouvement dans une surveillance de respiration ultrasonore
EP19824008.7A EP3893753A1 (fr) 2018-12-11 2019-12-10 Systèmes et procédés de compensation de mouvement dans une surveillance de respiration ultrasonore

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US16/216,632 US10398351B1 (en) 2018-12-11 2018-12-11 Systems and methods for motion compensation in ultrasonic respiration monitoring
US16/216,639 2018-12-11
US16/216,639 US10595821B1 (en) 2018-12-11 2018-12-11 Ultrasonic transducer device for respiration monitoring
US16/216,632 2018-12-11
US16/520,798 2019-07-24
US16/520,798 US10568542B1 (en) 2018-12-11 2019-07-24 Systems and methods for motion compensation in ultrasonic respiration monitoring

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