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WO2014140532A1 - Dispositif à pression expiratoire positive avec surveillance électronique - Google Patents

Dispositif à pression expiratoire positive avec surveillance électronique Download PDF

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Publication number
WO2014140532A1
WO2014140532A1 PCT/GB2014/050656 GB2014050656W WO2014140532A1 WO 2014140532 A1 WO2014140532 A1 WO 2014140532A1 GB 2014050656 W GB2014050656 W GB 2014050656W WO 2014140532 A1 WO2014140532 A1 WO 2014140532A1
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WIPO (PCT)
Prior art keywords
flow
air
sensor
pressure
internal chamber
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2014/050656
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English (en)
Inventor
Benjamin Wolf Heller
Martin James WILDMAN
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Sheffield Hallam University
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Sheffield Hallam University
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Publication date
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Publication of WO2014140532A1 publication Critical patent/WO2014140532A1/fr
Anticipated expiration legal-status Critical
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Definitions

  • the present invention relates to an electronic monitoring device suitable for use with a positive expiratory pressure (PEP) device and in particular, although not exclusively to a device having a sensor configured to detect a change in pressure within the device and a time recorder to record a time period associated with the start and end of a flow of air through the device corresponding to a patient exhaling into the device.
  • PEP positive expiratory pressure
  • Bronchial drainage chest physiotherapy is a typical clinical treatment for the mobilisation and removal of airway secretions in a variety of different respiratory conditions including in particular cystic fibrosis, brochiectasis, bronchitis, bronchial asthma, primary ciliary dyskinesia syndrome.
  • This type of therapy has proven to be effective to maintain pulmonary function and inhibit respiratory complications in patients with chronic conditions.
  • standard CPT is very intensive with regard to labour and time for both hospitalised and non-hospitalised patients.
  • An example positive expiratory pressure (PEP) device (commonly referred to as an airways clearance adjunct) is disclosed in EP 1103287 and comprises a housing having an internal airflow passageway extending between an inlet and an outlet.
  • An oscillator is provided in communication with the passageway and is configured for obstructing and opening the airflow path so that a patient exhaling into the device via the inlet can experience an alternating resistance to flow through.
  • EP 1464357 also discloses a PEP device intended for multiple use and designed specifically to be easily assembled and disassembled for cleaning.
  • the device is further adapted such that its operation is positionally independent to facilitate manipulation and use during PEP therapy.
  • PEP positive expiratory pressure
  • an electronic monitoring device having a sensor and a time recorder that may form a component part of a PEP device or may be a component attachable to such a device and being sensitive to airflow passage through the device (corresponding to a patient exhaling).
  • the present device comprises a sensor, preferably in the form of a pressure transducer or switch together with a time recordal component such that the start and end of a single patient expiration through the device is identifiable.
  • the device comprises a processor in the form of a microcontroller together with a non- volatile memory suitable to record expiration patterns through the device as a patient repeatedly exhales into it during single and multiple prescribed therapeutic sessions.
  • the present device is configured to calculate breath duration, flow rate, flow volume and breath velocity for example.
  • the device comprises a pressure transducer i.e. a continuous sampling configuration
  • the frequency and amplitude of wave form oscillations may be monitored which in turn can be used to confirm i) the device is working properly and ii) the vibration speed and frequency which, are helpful to a clinician in assessing and prescribing the clinical programme.
  • the device may also comprise additional components such as wired and wireless communication ports and data storage facilities to allow a patient to build and transfer respiratory performance data for their own use and that of the responsible clinician to both monitor therapy adherence and performance.
  • an electronic monitoring device suitable for monitoring the passage of air through a positive expiratory pressure (PEP) device, the monitoring device comprising: a housing having an internal chamber with an airflow inlet and an airflow outlet to allow a flow of air through the internal chamber; a sensor positioned within the housing and configured to detect a change in pressure within the chamber including the start of a flow of air through the chamber and a termination of a flow of air through the chamber; and a time recorder to measure a time period between a detected change in pressure within the chamber corresponding to a start and a termination of a flow of air through the chamber.
  • PEP positive expiratory pressure
  • the device comprises a partition extending in a direction between the inlet and the outlet to separate the internal chamber into a passageway for the flow of air between the inlet and the outlet and a compartment to accommodate the sensor and timer recorder such that the sensor and the time recorder are separated from the flow of air through the passageway by the partition.
  • the device further comprises a diaphragm extending between a region of the passageway and the compartment and capable of deforming in response to a pressure change in the passageway.
  • the sensor is coupled to the diaphragm so as to be responsive to a pressure change in the compartment created by displacement of the diaphragm.
  • the device further comprises a processor coupled electronically to the sensor and the time recorder. More preferably, the processor is a microcontroller configured to control the sensor according to at least two modes of operation including a sleep mode having a first sample rate and a breath mode having a second sample rate, wherein the second sample rate is greater than the first sample rate.
  • the device further comprises any one or a combination of the following set of: a battery; a non-volatile memory; a sounder; an optical output device.
  • the time recorder is an electronic real time clock.
  • the device further comprises any one or a combination of the following set of: a wireless communication component; a wired communication component; a data storage component; an optical display.
  • the senor comprises a pressure transducer.
  • the sensor may comprise a pressure switch.
  • an oscillatory positive expiratory pressure (PEP) therapy device comprising an electronic monitoring device as claimed herein.
  • PEP oscillatory positive expiratory pressure
  • a positive expiratory peak flow meter comprising an electronic monitoring device as claimed herein.
  • an oscillatory positive expiratory pressure (PEP) therapy device comprising: a housing having an internal chamber and an airflow inlet and an airflow outlet to allow a flow of air through the internal chamber; an oscillator accommodated within the housing in communication with the airflow path between the inlet and the outlet, the oscillator configured for obstructing and opening the airflow path so that a patient exhaling into the device via the inlet can experience an alternating resistance to flow through the device; a sensor positioned within the housing and configured to detect a change in pressure within the internal chamber including the start of a flow of air through the internal chamber and a termination of a flow of air through the internal chamber; a time recorder to record a time period between a detected change in pressure within the internal chamber corresponding to the start and termination of the flow of air through the internal chamber.
  • PEP oscillatory positive expiratory pressure
  • the device further comprises a mouthpiece releasably connectable to the inlet of the PEP therapy device, the mouthpiece comprising a housing having an internal chamber and an inlet and an outlet to allow a flow of air through the internal chamber; wherein the sensor and the time recorder are accommodated within the mouthpiece housing.
  • the device is a hand-held airways adjunct.
  • the device may be a hand-held peak flow meter.
  • the sensor for identifying a pressure change in the internal passageway of the device is a flow rate sensor or a temperature sensor.
  • Other electronic components may also be employed for this purpose and are suitable if they can identify a change in the environmental state within the passageway indicative of a breath through the device being resultant from a user breathing into it.
  • FIG 1 is an external perspective view of an oscillatory positive expiratory pressure (PEP) therapy device connectable with an electronic monitoring device, in the form of a mouthpiece attachable to the PEP device according to a specific implementation of the present invention
  • Figure 2 is a cross sectional side elevation view of the mouthpiece component of figure 1 ;
  • PEP oscillatory positive expiratory pressure
  • Figure 3 is a cross sectional side elevation view of the PEP therapy device of figure 1;
  • Figure 4 is a schematic illustration of various components of the electronic monitoring device of figure 1 ;
  • Figure 5 is schematic flow diagram of the control of the pressure transducer by a microcontroller according to three different pressure sampling modes according to a specific implementation of the present invention
  • Figure 6 illustrates an expiratory wave form of a patient that has exhaled through a PEP device comprising electronic pressure monitoring according to one aspect of the present invention.
  • an airways adjunct device 100 comprises a main housing 102 having a generally hollow cylindrical configuration.
  • a short tube section 108 extends axially from a first end 110 of housing 102.
  • Tube 108 comprises an open outermost first end that forms an inlet 103 for the adjunct 100.
  • An opposed second end 111 of housing 102 also comprises a short tube 112 having an open outermost end that forms an air intake 115.
  • tube 108, housing 102 and tube 112 are aligned concentrically about central longitudinal axis 113.
  • the device 100 further comprises a plurality of airflow outlets 104 formed at regions of housing 102.
  • Adjunct 100 is connectable to a mouthpiece 101 attached to the inlet tube 108.
  • Mouthpiece 101 comprises a housing 109 defining an internal chamber having an inlet opening 106 and an outlet opening 105 positioned at opposite ends.
  • a flange 107 extends around outlet 105 and is configured to mate around an outward facing surface of tube 108 so the tube 108 may be inserted within a region 114 about mouthpiece housing 109 to releasably secured mouthpiece 101 to adjunct 100.
  • adjunct 100 comprises an internal chamber 311 defined by housing 102.
  • a region of chamber 311 is partitioned by an internal wall 300 extending between inlet 103 and intake 115.
  • Wall 301 defines an internal passageway 312 between inlet 103 and intake 1 15.
  • An aperture or opening 301 is formed within a region of wall 300 towards intake end 115.
  • a one way flap valve 302 extends immediately in board of intake 115 and prevents air flowing out of device 100 at this region.
  • An oscillatory mechanism is mounted within chamber 311 externally of passageway 312 so as to extend over aperture 301.
  • the mechanism comprises an elongate beam 304 mounted upon a pivot mounting 303 substantially at a mid-point along its length via a pivot pin 305.
  • a weight 309 is provided at a first end 314 of beam 304 and a magnetically susceptible tab 307 is attached to a second end 308 of beam 304.
  • a magnet arrangement 306 is mounted at an external region of passageway wall 300 so as to be positioned opposed to tab 307 in close contact.
  • a conical plug 310 extends downwardly from an underside surface of beam 304 to project towards aperture 301 and is dimensioned with a diameter corresponding to a diameter of aperture 301.
  • beam 304 is configured to pivot laterally about pin 305 such that plug 310 is effected to completely close and open aperture 301.
  • air is introduced into passageway 312 as a user exhales into device 100 via inlet 103.
  • the airflow path to outlet 104 is blocked by flap 302 such that air is prevented from flowing through opening 301.
  • aperture 301 is closed by plug 310 until pressure at its underside increases sufficiently to overcome the attractive force of magnet 306 on tab 307. Once this occurs, beam 304 pivots via a sudden motion such that air escapes from housing 102 via outlet gills 313.
  • FIG. 3 illustrates the internal components of the mouthpiece part 101 of figure 1 comprising selected electronic components to provide an attachable electronic monitoring device for use with airways adjunct 100.
  • Housing 109 defines an internal chamber 202.
  • Chamber 202 is divided about axis 113 by a partition wall 200 extending in a direction between inlet 106 and outlet 105 to define an airflow passageway 201.
  • An opening aperture 210 is formed within partition 200.
  • a flexible diaphragm 204 extends across and seals opening 210 to prevent the flow of air from passageway 201 beyond wall 200.
  • a cap extends to cover diaphragm 204 and projects from the perimeter of opening 210 to define a pocket region 203 into which diaphragm 204 is capable of being displaced by a positive pressure within passageway 201.
  • a compartment region 211 is created between housing 109 and the opposite side of partition wall 200 relative to passageway 201. Compartment 211 accommodates a plurality of electronic components including in particular a microcontroller 207 and a pressure transducer 206 coupled electronically to the microcontroller 207 which in turn is mounted upon a suitable PCB 212.
  • a conduit 208 provides a link between sensor 206 and the diaphragm pocket 203 such that a change in pressure within the region of pocket 203 is detectable by sensor 206 as diaphragm 204 is displaced radially outward from passageway 201 and into pocket 203.
  • Mouthpiece 101 is attached to adjunct 100 as tube 108 is partially accommodated within region 114 of mouthpiece cavity 202.
  • the device is then ready for use according to the therapeutic programme prescribed and to dislodge mucus within the passageways of the patient via the oscillatory motion of the beam 304.
  • the electronic monitoring device 101 comprises a variety of different electronic components including in particular: a microcontroller 207 (such as a PIC16LF series); a pressure transducer (such as a Honeywell TruStabilityTM sensor); a battery 400 (such as a CR2032); a non-volatile memory 402 (such as flash SDRAM); an optical display LED 403; an audio sounder 404; a real time clock 401 (such as a 32kHz watch crystal); a USB port 406 to interface with a PC and a wireless communication port/device 405 for wireless transfer of data from device 101 to a PC.
  • the electronic components of figure 4 are mountable upon common PCB 212.
  • Microcontroller 207 is configured specifically to maximise the lifetime of battery 400. This is achieved via software implementation and the control of the pressure transducer 206 according to a plurality of operative states. In particular, pressure transducer 206 is operated according to a first 'low' speed sample rate that may be approximately 1 sample per second; a second 'medium' speed sample state being approximately 10 to 20 cycles per second and; a 'high' sample speed rate being approximately 100 samples per second.
  • the present device via a microcontroller 207, is configured automatically to switch between the different transducer states in response to pressure changes within passageway 201. In particular and referring to figure 5, transducer 206 is first operative in the low sample speed 500.
  • stage 501 if the pressure within passageway 201 (being monitored via transducer 206) exceeds a threshold value transducer 206 is adjusted to start high speed sampling 502 corresponding to user exhaling into device 101 via inlet 106.
  • a breath start time is recorded via clock 401.
  • High speed sampling continues 503 until the pressure within passageway 201 drop below a predetermined value 504 to result in a recordal of an end of breath 506.
  • the sample is recorded at 505 if the pressure is above the predetermined level.
  • the breath characteristics are saved 507 via memory 402.
  • Transducer 406 downgrades to the medium sample state 508 and is then in a state waiting for a further breath. If a breath is detected via an increased pressure 509 the high speed sampling loop is re-entered at 502. Transducer 206 may be configured to 'time-out' after for example one minute to revert to the low speed sampling rate 511 to restart the cycle 500. Alternatively transducer 206 reengages the medium sample rate 508 for possible high speed sampling and a new set of breath characteristic recordings.
  • Figure 6 illustrates a typical breath wave form resultant from a user exhaling into mouthpiece 101. The breath start is indicated by the initial peak 601. The pressure curve then decreases gradually until the end of breath peak 602.
  • the intermediate oscillations 603 correspond to the oscillations of beam 304 and the resistance to the airflow through opening 301 via the oscillatory mechanism within the adjunct 100.
  • the pressure transducer 206 and recordal component 401 it is possible to generate the wave form profile 600 of figure 6 to enable the calculation of additional breath
  • memory storage may be provided to allow large data volume to be obtained and stored at device 101 for subsequent download to a PC via wired 406 or wireless 405 communication.
  • monitoring device 101 is removably attachable to the PEP device 100.
  • device 101 may be formed integrally with PEP device 100 which, alternatively, may be a peak flow meter.

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

Abstract

La présente invention concerne un dispositif de surveillance (101) adapté à surveiller le passage d'air dans un dispositif à pression expiratoire positive (PEP) (100). Le dispositif de surveillance comprend un capteur (206) positionné à l'intérieur d'un logement (109) et configuré pour détecter une modification de pression à l'intérieur d'une chambre de dispositif (202) y compris le début et la fin d'une respiration expirée dans le dispositif. Un dispositif d'enregistrement de durée (401) mesure la durée entre le début et la fin d'une respiration. Le dispositif est adapté à automatiquement enregistrer un utilisateur à l'aide du dispositif à PEP et en respectant un programme clinique particulier.
PCT/GB2014/050656 2013-03-15 2014-03-06 Dispositif à pression expiratoire positive avec surveillance électronique Ceased WO2014140532A1 (fr)

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GB1304742.8 2013-03-15
GB1304742.8A GB2512047B (en) 2013-03-15 2013-03-15 Positive Expiratory Pressure Device With Electronic Monitoring

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WO2016079461A1 (fr) * 2014-11-19 2016-05-26 Smiths Medical International Limited Appareil de thérapie respiratoire
WO2016092247A1 (fr) * 2014-12-11 2016-06-16 Smiths Medical International Limited Appareil de thérapie respiratoire
WO2017178776A1 (fr) * 2016-04-14 2017-10-19 Smiths Medical International Limited Dispositifs de thérapie respiratoire
WO2017187116A1 (fr) 2016-04-27 2017-11-02 Smiths Medical International Limited Appareil de thérapie respiratoire
FR3057466A1 (fr) * 2016-10-18 2018-04-20 Physioblue Dispositif pour renforcer des muscles respiratoires.
CN115475313A (zh) * 2021-06-15 2022-12-16 岩成科技事业股份有限公司 震荡式吐气正压装置
CN118304530A (zh) * 2024-06-10 2024-07-09 广州医科大学附属第一医院（广州呼吸中心） 一种气道廓清技术的振荡呼气正压装置

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US10894142B2 (en) 2016-03-24 2021-01-19 Trudell Medical International Respiratory care system with electronic indicator
WO2017199215A1 (fr) 2016-05-19 2017-11-23 Trudell Medical International Chambre de retenue à valve intelligente
EP3481476B1 (fr) 2016-07-08 2021-09-08 Trudell Medical International Dispositif intelligent de pression expiratoire positive oscillante
JP7093353B2 (ja) 2016-12-09 2022-06-29 トゥルーデル メディカル インターナショナル スマートネブライザ
CA3086890A1 (fr) 2018-01-04 2019-07-11 Trudell Medical International Dispositif intelligent a pression expiratoire positive oscillante
US11395890B2 (en) 2018-06-04 2022-07-26 Trudell Medical International Smart valved holding chamber
CN109621326B (zh) * 2018-12-30 2020-12-11 北京化工大学 一种机械式震荡呼吸训练检测装置
AU2020338979B2 (en) 2019-08-27 2025-09-25 Trudell Medical International Inc. Smart oscillating positive expiratory pressure device
CN113648619A (zh) * 2021-09-26 2021-11-16 重庆上品益生电子商务有限公司 呼吸训练器

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016079461A1 (fr) * 2014-11-19 2016-05-26 Smiths Medical International Limited Appareil de thérapie respiratoire
WO2016092247A1 (fr) * 2014-12-11 2016-06-16 Smiths Medical International Limited Appareil de thérapie respiratoire
WO2017178776A1 (fr) * 2016-04-14 2017-10-19 Smiths Medical International Limited Dispositifs de thérapie respiratoire
WO2017187116A1 (fr) 2016-04-27 2017-11-02 Smiths Medical International Limited Appareil de thérapie respiratoire
FR3057466A1 (fr) * 2016-10-18 2018-04-20 Physioblue Dispositif pour renforcer des muscles respiratoires.
WO2018073531A1 (fr) * 2016-10-18 2018-04-26 Physioblue Dispositif pour renforcer des muscles respiratoires
CN115475313A (zh) * 2021-06-15 2022-12-16 岩成科技事业股份有限公司 震荡式吐气正压装置
JP2022191172A (ja) * 2021-06-15 2022-12-27 岩成科技事業股▲フン▼有限公司 振動式呼気陽圧装置
CN118304530A (zh) * 2024-06-10 2024-07-09 广州医科大学附属第一医院（广州呼吸中心） 一种气道廓清技术的振荡呼气正压装置
CN118304530B (zh) * 2024-06-10 2024-08-27 广州医科大学附属第一医院（广州呼吸中心） 一种气道廓清技术的振荡呼气正压装置

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GB2512047B (en) 2015-07-15
GB201304742D0 (en) 2013-05-01

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